Senate Hearing, 107TH Congress - Bioterrorism, 2001

S. HRG.
107452
BIOTERRORISM, 2001
HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
SPECIAL HEARINGS
OCTOBER 3, 2001WASHINGTON, DC
OCTOBER 28, 2001WASHINGTON, DC
NOVEMBER 2, 2001WASHINGTON, DC
NOVEMBER 29, 2001WASHINGTON, DC
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COMMITTEE ON APPROPRIATIONS
ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii TED STEVENS, Alaska
ERNEST F. HOLLINGS, South Carolina THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont ARLEN SPECTER, Pennsylvania
TOM HARKIN, Iowa PETE V. DOMENICI, New Mexico
BARBARA A. MIKULSKI, Maryland CHRISTOPHER S. BOND, Missouri
HARRY REID, Nevada MITCH MCCONNELL, Kentucky
HERB KOHL, Wisconsin CONRAD BURNS, Montana
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama
BYRON L. DORGAN, North Dakota JUDD GREGG, New Hampshire
DIANNE FEINSTEIN, California ROBERT F. BENNETT, Utah
RICHARD J. DURBIN, Illinois BEN NIGHTHORSE CAMPBELL, Colorado
TIM JOHNSON, South Dakota LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island MIKE DEWINE, Ohio
TERRENCE E. SAUVAIN, Staff Director
CHARLES KIEFFER, Deputy Staff Director
STEVEN J. CORTESE, Minority Staff Director
LISA SUTHERLAND, Deputy Minority Staff Director
SUBCOMMITTEE ON DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND

EDUCATION, AND RELATED AGENCIES
TOM HARKIN, Iowa, Chairman
ERNEST F. HOLLINGS, South Carolina ARLEN SPECTER, Pennsylvania
DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi
HARRY REID, Nevada JUDD GREGG, New Hampshire
HERB KOHL, Wisconsin LARRY CRAIG, Idaho
PATTY MURRAY, Washington KAY BAILEY HUTCHISON, Texas
MARY L. LANDRIEU, Louisiana TED STEVENS, Alaska
ROBERT C. BYRD, West Virginia MIKE DEWINE, Ohio
Professional Staff
ELLEN MURRAY
JIM SOURWINE
MARK LAISCH
ADRIENNE HALLETT
ERIK FATEMI
ADAM GLUCK
BETTILOU TAYLOR (Minority)
MARY DIETRICH (Minority)
SUDIP SHRIKANT PARIKH (Minority)
Administrative Support
CAROLE GEAGLEY
EMMA ASHBURN (Minority)
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CONTENTS
WEDNESDAY, OCTOBER 3, 2001

Page
Opening statement of Senator Tom Harkin .......................................................... 1
Prepared statement of the American Pharmaceutical Association ..................... 3
Prepared statement of the American Society of Clinical Pathologists ................ 5
Prepared statement of the Commissioned Officers Association of the U.S.
Public Health Service .......................................................................................... 6
Prepared statement of the Association of State and Territorial Health Offi-
cials .......................................................................................................................
Opening statement of Senator Arlen Specter ........................................................ 13
Opening statement of Senator Robert C. Byrd ..................................................... 14
Statement of Hon. Edward M. Kennedy, U.S. Senator from Massachusetts ..... 16
Prepared statement .......................................................................................... 19
Statement of Hon. Bill Frist, U.S. Senator from Tennessee ................................ 20
Statement of Hon. Chuck Hagel, U.S. Senator from Nebraska ........................... 28
Statement of Hon. John R. Edwards, U.S. Senator from North Carolina .......... 29
Statement of Hon. Tommy G. Thompson, Secretary, Department of Health
and Human Services ............................................................................................ 32
Opening statement of Senator Mike DeWine ........................................................ 46
Opening statement of Senator Richard J. Durbin ................................................ 46
Opening statement of Senator Judd Gregg ........................................................... 48
Opening statement of Senator Herb Kohl ............................................................. 49
Statement of Jonathan Tucker, Ph.D., director, Chemical & Biological Weap-
ons Nonproliferation Program, Monterey Institute of International
Studies .................................................................................................................. 52
Statement of Stephen Cantrill, M.D., associate director, Department of Emer-
gency Medicine, Denver Health Medical Center ............................................... 62
Statement of Jerome M. Hauer, managing director, Crisis and Consequences
Management, Kroll Associates ............................................................................ 66
Statement of Patricia Quinlisk, M.D., M.P.H., medical director and State
epidemiologist, Iowa Department of Health ...................................................... 68
Statement of Rex Archer, M.D., M.P.H., director, Kansas City Health Depart-
ment ...................................................................................................................... 79
TUESDAY, OCTOBER 23, 2001

Statement of Jeffrey P. Koplan, M.D., M.P.H., Director, Centers for Disease
Control and Prevention, Department of Health and Human Services ............ 98
Statement of James T. Caruso, Deputy Assistant Director, Counterterrorism
Division, Federal Bureau of Investigation, Department of Justice .................. 109
Statement of Bob Kramer, president and chief operating officer, Bioport Cor-
poration ................................................................................................................. 123
Statement of Mary Kuhn, vice president of operations, Bayer Corporation ....... 129
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IV
Page
Statement of Barbara Hunt, R.N., M.P.A., district health officer, Washoe
County Health Department, Reno, Nevada ....................................................... 133
Statement of Hilary Koprowski, M.D., president, Biotechnology Foundation,
Inc., Philadelphia, PA, professor, Department of Microbiology and Immu-
nology, director, Center of Neurovirology and Biotechnology Foundation
Laboratories at Thomas Jefferson University ................................................... 136
Statement of Thomas P. Monath, M.D., vice president for Research and
Medical Affairs, Acambia, Inc. ............................................................................ 138
Statement of Mary J.R. Gilchrist, Ph.D., director, University of Iowa Hygienic
Laboratory ............................................................................................................ 141
FRIDAY, NOVEMBER 2, 2001

Opening statement of Senator Robert C. Byrd ..................................................... 157
Opening statement of Senator Ted Stevens .......................................................... 160
Statement of Anthony S. Fauci, M.D., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health, Department of
Health and Human Services ............................................................................... 160
Statement of James W. LeDuc, Ph.D., Acting Director, Division of Viral
and Rickettsial Diseases, National Center for Infectious Diseases, Centers
for Disease Control and Prevention, Department of Health and Human
Services ................................................................................................................. 164
Statement of Michael Friedman, M.D., chief medical officer for biomedical
preparedness, Pharmaceutical Research and Manufacturers of America ....... 171
Statement of M. Anita Barry, M.D., M.P.H., director, Communicable Disease
Control, Boston Public Health Commission, and member, National Associa-
tion of County and City Health Officials ........................................................... 177
THURSDAY, NOVEMBER 29, 2001

Opening statement of Senator Ted Stevens .......................................................... 204
Statement of Jeffrey P. Koplan, M.D., M.P.H., Director, Centers for Disease
Control and Prevention, Department of Health and Human Services ............ 205
Statement of Anthony S. Fauci, M.D., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health .................................... 210
Opening statement of Senator Herb Kohl ............................................................. 218
Opening statement of Senator Mary L. Landrieu ................................................. 224
Statement of Ken Alibek, M.D., president, Advanced Biosystems, Inc. .............. 229
Statement of Joseph Barbera, M.D., associate professor and co-director, Insti-
tute for Crisis, Disaster, and Risk Management, the George Washington
University ............................................................................................................. 233
Statement of Joseph LeValley, senior vice president for planning and systems
development, Mercy Medical Center of Des Moines, Des Moines, Iowa .......... 237
BIOTERRORISM
WEDNESDAY, OCTOBER 3, 2001
U.S. SENATE,
SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN
SERVICES, AND EDUCATION, AND RELATED AGENCIES,
COMMITTEE ON APPROPRIATIONS,
Washington, DC.
The subcommittee met at 10:35 a.m., in room 216, Hart Senate
Office Building, Hon. Tom Harkin (chairman) presiding.
Present: Senators Harkin, Byrd, Kohl, Murray, Durbin,
Landrieu, Specter, Gregg, and DeWine.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator HARKIN. Good morning. The hearing of the Appropria-

tions Subcommittee on Labor, Health and Human Services, and
Education, and Related Agencies, will come to order.
History will note that on September 11, 2001, our freedom was
attacked. These attacks have made us realize that a free America
must be a vigilant America. Vigilance requires that we prepare to
meet the likely threats posed by our enemies. While I do not want
to overstate its likelihood, or incite unnecessary panic, we must
take a hard look at the threat posed by biological weapons and our
Nations preparedness to meet that threat.
This is not science fiction fantasy. Iraq had a biological weapons
program, although we have no evidence that it was successful.
They had already shown a willingness to use chemical weapons on
combat against their own citizens. I believe we are not far from the
day when a nation or organization will possess both biological
weapons and chemical weapons and the will to use them, so the
time for us to prepare is now.
Preparedness requires an investment in our public health infra-
structure on the local, State, and Federal level. They must have the
resources and expertise needed to respond to an array of terrorist
actions. It is no longer a matter of public health, it is a matter of
national defense.
Imagine how we would meet a biological attack, given our Na-
tions current state of readiness. On May 20, a western States de-
partment of public health begins receiving reports that increasing
numbers of people are seeking medical attention at a citys area
hospital for coughing and fever during the previous evening. By
early afternoon on May 20, 500 persons with these symptoms have
received medical care, and 25 have died.
The State declares a public health emergency. Hospitals and clin-
ics around the area who just days before were dealing with what
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2
appeared to be just an unusual case of influenza are recalling

staffs, but hospital staffs are beginning to call in sick. More and
more people and resources are scarce. The States Governor then
restricts travel, including bus, rail, and air travel into and out of
the affected area. All antibiotics that can be used to prevent or
treat the plague are commandeered. Citizens are told to seek treat-
ment at a medical facility if theyre feeling ill. By the end of that
day, 783 cases of pneumonic plague have occurred, and 123 people
have died.
On day 2, May 21, a cable news network reports that a national
crash effort is underway to move large quantities of antibiotics to
the region. A push pack of needed medical supplies from the Na-
tional Pharmaceutical Stockpile arrives in the city, but there are
great difficulties moving antibiotics from the stockpile delivery
point to the persons who need it for treatment. Out-of-State cases
now begin to be reported. The CDC notifies bordering States of the
epidemic.
On day 3, May 22, hospitals cannot manage the influx of sick pa-
tients. By noon, there are 3,060 United States and international
cases of the plague and 795 have died.
On the day 4, May 23, there are conflicting reports of the number
of sick and dead. Some reports show an estimated 3,700 cases of
pneumonic plague, with 950 deaths. Others are reporting over
4,000 cases, and more than 2,000 deaths.
The good news from this? This was an exercise, just an exercise.
In this scenario, an aerosol of plague, (Y. pestis) bacilli was re-
leased at the Denver Performing Arts Center, and we can see the
results of this. Clearly, we are not sufficiently prepared, but we
have made some progress.
Several years ago, this subcommittee, under the leadership of
Senator Specter from Pennsylvania, began to put more and more
effort into protecting us from bioterrorism. Over the past 2 years,
we have appropriated $545 million to the Center for Disease Con-
trol for this purpose. That investment has improved the detection,
treatment, and containment of a potential bioterrorist attack by
strengthening the Federal, State, and local partnerships that are
the first and even second lines of defense. In addition, two of our
distinguished witnesses, Senators Kennedy and Frist, led the effort
to pass the Public Health Threats and Emergencies Act. That legis-
lation will further strengthen our efforts.
In the near term, we will put forward a plan on how to allocate
the $20 billion in anti-terrorism funds we approved 2 weeks ago.
It is my hope that this hearing will help us focus on how a portion
of those funds can be used to combat bioterrorism. Should the un-
thinkable happen, our local public health departments will be the
first line of defense. Unlike a conventional or chemical weapons at-
tack, a biological weapon can be launched and can strike without
even a sound.
It will be our emergency room personnel and urgent care pro-
viders who will recognize the attack and counter it. That requires
training and effective surveillance systems that can put pieces of
information together in a meaningful plan. That is how public
health threats are tracked and contained.
3
For example, in New York, a doctor who had recently attended

a public health seminar on the importance of this type of tracking
and reporting had the presence of mind to report two unusual cases
of encephalitis to the public health department. That information
led to the identification of the West Nile virus outbreak.
In the case of biological weapons, we will require trained per-
sonnel and equipment to first detect the attack, the ability to treat
a large number of exposed individuals, and immediate access to the
necessary pharmaceuticals, whether it be vaccines, antibiotics, or
something else.
We have made some progress in meeting the threat, but how
much further do we need to go to protect Americans from a biologi-
cal attack? That is the question we must address today.
We have a very distinguished and knowledgeable panel of wit-
nesses, who I know will add a great deal to this hearing, and I
want to thank them for joining us. Before we begin with our first
distinguished panel, I would ask unanimous consent that a number
of statements from various experts who asked to testify today, but
who were unable to be accommodated, be inserted into the record.
[The statements follow:]
PREPARED STATEMENT OF THE AMERICAN PHARMACEUTICAL ASSOCIATION
The American Pharmaceutical Association (APhA), the national professional soci-
ety of pharmacists, is pleased that the Committee is addressing the important issue
of bioterrorism and ways to prepare for and provide a response to a biological or
chemical terrorist attack. APhA is the first established and largest professional as-
sociation of pharmacists in the United States. APhAs 50,000 members include prac-
ticing pharmacists, pharmaceutical scientists, pharmacy students, pharmacy techni-
cians, and others interested in advancing the profession. Pharmacy is the third larg-
est health profession in America. The Association is extremely proud of the role our
pharmacist members played in meeting the needs of individuals who, in the after-
math of the terrorist attacks, were stranded away from home or working on rescue
efforts and were in need of medications or other healthcare needs.
The roots of pharmacys involvement with public health initiatives go back well
over a century. Pharmacists have served as local, decentralized extenders of public
health departments, playing a major role in the distribution and administration of
vital vaccines, medications, supplies and health care services.1 The nations phar-
macists have demonstrated a serious commitment to preventing disease and stand
ready to serve the needs of our nation in the event of a biological or chemical attack.
Indeed, the profession recognizes the deadly threat that an attack of this nature
would pose with the population of our nation at risk of fatal infection with little no-
tice. When an attack occurs, time will be short to mount a preventive program to
preserve the publics health. Pharmacists accessibility in every community provides
an excellent opportunity to reach individuals in need of preventive care, healthcare
services, medications and supplies, vaccines, and information. Pharmacists want to
actively participate in whatever response or preventive plan is implemented, and
are available to assist in preparedness efforts and response to bioterrorism. APhA
pledges its services and communications vehicles to help mobilize this vital resource.
Pharmacists contributions to such efforts can include: Monitoring for and surveil-
lance of signs and symptoms of a possible biological or chemical attack. Pharmacists
are a trusted source of health care information for the public. Patients often seek
the advice of pharmacists, even before going to a physician, when they require
health information. The initial symptoms presented by several potential biological
agents that could be utilized against our citizenry resemble those of the flu. Many
patients may attempt to self medicate and will seek a remedy from their local phar-
macy shelf before going to the physicians office or hospital. As one of the most ac-
cessible health care professionals, pharmacists are in an excellent position to assist
in monitoring any patterns of symptoms or diseases reported by patients. Phar-
1 Pharmacy in History, American Institute of the History of Pharmacy; Vol. 41, pgs. 137149,
1999.
4
macists involvement in this area can help to serve as an early warning that a bio-
terrorism attack has occurred.
The pharmacist is an expert in medication use, both prescription and over-the-
counter. This expertise is invaluable in determining which pharmaceuticals should
be stored and which can be used as second and third line agents if the supply of
first line agents is limited.2
The resources and talents of the nations pharmacists may be extended beyond
dispensing necessary medications and working with patients to make those medica-
tions work. For example, pharmacists in 31 states may administer vaccines and pro-
vide general support for immunization programs. There is substantial evidence that
pharmacists are readily accessible, trusted professionals who can motivate the pub-
lic to be vaccinated and enhance vaccine delivery. These capabilities will be helpful
in a national infectious disease emergency. Here are some of the practical ways
pharmacists could help:
Community pharmacists at more than 52,000 neighborhood pharmacies can edu-
cate the public and, in 31 states, actually immunize them. In many rural areas, a
pharmacist is the only health professional conveniently located to patients. The na-
tions community pharmacies could serve as 52,000 bases of operation and commu-
nication for immunization programs coordinated by state health departments.
Pharmacists in hospitals and other health systems can educate, motivate, support,
and immunize inpatients and outpatients in these settings. As medication experts,
pharmacists link the clinical, logistic, and administrative functions of hospitals and
health systems.
Consultant pharmacists can enhance immunization delivery to residents of nurs-
ing homes and other institutions. Consultant pharmacists review residents drug
regimens monthly and are already integral contributors to health quality in these
settings.
Pharmacists are trained to take any of three roles in support of the national pre-
paredness plan. These three roles are:
Motivating: Pharmacists can distribute literature, display posters, perform one-on-
one counseling, speak to local civic groups, and similar activities. Scientific studies
demonstrate that 50 percent to 94 percent of the people to whom a pharmacist rec-
ommends immunization accept this recommendation.3 In the confusion and uncer-
tainty possible in any national immunization campaign, pharmacists can be voices
of reason and sources of factual information and advice.
Hosting: In 1997, more than 5 million doses of influenza vaccine were adminis-
tered at more than 15,000 pharmacies across the country, more than one-quarter
of all pharmacies. Even in the pharmacies where pharmacists are not yet trained
to immunize, nurses or other vaccine providers could administer vaccines or estab-
lish vaccine supply depots. These sites are equipped to store refrigerated medica-
tions, are widely dispersed in urban, suburban, and rural settings, near population
centers of diverse sizes. Most are open long hours and have large parking lots that
could accommodate large patient flows. Further, given that more than 95 percent
of pharmacies already have electronic communications capabilities, pharmacies
could serve as communication centers for sending and receiving instructions and
data between state health authorities and field workers during a pandemic. In addi-
tion, pharmacists can serve as information resources to consumers, media, and other
health care professionals.
Immunizing: Estimates are that there are currently more than 3,000 immunizing
pharmacists, delivering more than 300,000 doses of vaccine to adults during recent
flu seasons. Pharmacists are authorized to administer drugs in 31 states, cor-
responding to a population of over 135 million people. Additional states are consid-
ering empowering pharmacists with this authority to advance the public health.
Pharmacists could be enlisted to administer vaccine dose(s) during bioterrorism
events, reporting to state authorities, as well as providing areas for vaccine and
medication storage and distribution.
APhA has made available to its members educational programming focusing on
bioterrorism at Association annual meetings. Additionally, a bioterrorism resource
center located on APhAs homepage (www.aphanet.org) was developed to assist
pharmacists and consumers with education about and preparing for a bioterrorism
attack.
All of these actions will be greatly facilitated by having Congress express interest
in including the nations pharmacists in plans to defend the nation against these
threats.
2 Supplement to the Journal of the American Pharmaceutical Association, September/October

2000.
3 Spruill et al., 1982; Grabenstein et al., 1986; Morton et al., 1988; Grabenstein et al., 1990.
5
Thank you for the opportunity to provide comments on this important issue. The
American Pharmaceutical Association and its members stand ready to assist the
government in any way possible to prepare for and respond to bioterrorism.
Contact information: American Pharmaceutical Association 2215 Constitution Av-
enue, NW Washington, DC 20037 (202) 4297575.
PREPARED STATEMENT OF THE AMERICAN SOCIETY OF CLINICAL PATHOLOGISTS

In light of the tragic events of September 11, 2001, we appreciate you holding this
hearing to address the issue of bioterrorism. We hope the following comments will
provide you with some specific suggestions on how to improve the public health in-
frastructure and prepare for potential biological and chemical attacks.
As the worlds largest organization representing laboratory personnel, the Amer-
ican Society of Clinical Pathologists 75,000 board certified pathologists, clinical sci-
entists, certified technologists and technicians, are the individuals most likely to
first receive patient specimens for etiologic agents that are likely to be used in bio-
terrorism and toxins that may be used as chemical weapons. These professionals
must provide prompt and accurate laboratory test results so that a potential out-
break can be detected, provide support for hospitals and clinics caring for affected
patients, and assist in the development of an integrated epidemiologic network, es-
pecially for law enforcement purposes.
Bioterrorist events will likely present as outbreaks of acute febrile illnesses or as
unusual infectious diseases with no readily apparent point source. Therefore, clini-
cians will rely heavily upon laboratory tests for diagnostic clues as to the etiologic
agent. Laboratory professionals must be trained to identify microbial pathogens like-
ly to be used for bioterrorism, to safely collect, transport, and process specimens con-
taining biological agents associated with bioterrorist acts, to follow chain of custody
and other legal requirements, and to have familiarity with needs of mass disaster
support services.
Unfortunately, there is growing concern over the serious shortage of medical lab-
oratory personnel in our nations health care system. In the United States, vacancy
rates for seven of ten key laboratory medicine positions are at an all time high.
Since the early 1980s, the number of accredited educational programs for laboratory
positions has decreased significantly, and laboratory professionals who entered the
workforce in the 1960s and 1970s will be retiring soon.
To assist in reversing this shortage, we respectfully request two amendments to
the legislation offering appropriations for the Public Health Improvement Act, Pub-
lic Law 106505. Specifically, we ask that the legislation allow schools and pro-
grams of allied health to qualify for grants. The Public Health Threats and Emer-
gencies; Education of Medical and Public Health Personnel program already allows
grants to be given to state or local public health agencies to train laboratory per-
sonnel in the recognition or identification of resistance in pathogens. Similarly, we
ask that schools and programs be eligible for grants in order to train medical labora-
tory personnel in disciplines that recognize or identify a potential biological agent.
The Public Health Threats and Emergencies; Public Health Countermeasures to a
Bioterrorist Attack program allows states, hospitals, clinics, or primary care facili-
ties to qualify for grants to enhance the ability of personnel to recognize the symp-
toms and epidemiological characteristics of exposure to a potential weapon. The
Centers for Disease Control and Prevention should implement these training initia-
tives, and provide grants to schools and programs that train medical laboratory per-
sonnel and to other public or private non-profit entities. We suggest appropriating
$25 million for education training grants. The Association of Public Health Labora-
tories concurs with this approach.
Also, in order to protect the health of the citizens of the United States from bioter-
rorism, emerging infectious diseases, foodborne diseases, and environmentally asso-
ciated diseases, it is imperative to establish a national system of laboratories to help
detect, coordinate, and control these threats. A national laboratory system is where
public health, hospital and independent laboratories throughout the United States
would build a collaborative infrastructure, to assure that timely and accurate lab-
oratory information can be shared. The Centers for Disease Control and Prevention
has determined that maintaining and developing a national laboratory system that
is efficient at detecting and timely in reporting is critical to minimize the negative
impact of disease or other adverse public health events in the community. A na-
tional laboratory system is intended to assure the availability of consistent public
health laboratory capacity regardless of the location.
Development of a national laboratory system is already underway with the estab-
lishment of four demonstration projects in Nebraska, Minnesota, Michigan and
6
Washington state, but much more needs to be accomplished to weave an effective
national system, and quickly. A national laboratory system would permit partner-
ship building among clinical laboratories, public health laboratories, and the govern-
ment. It would assess staffing and capacity needs, provide guidance for training in
bioterrorism specimens, and create voluntary standards for the public health infra-
structure.
To carry out this function, we respectfully request $50 million for the national lab-
oratory system. To maintain the system, an additional $50 million should be author-
ized for future years.
The American Society of Clinical Pathologists also supports funding the Centers
for Disease Control and Prevention at $500 million for building and upgrading state
and local public health capacity.
Thank you for the opportunity to comment on this critical public health concern.
If you have questions or need additional information, please contact the American
Society of Clinical Pathologists at (202) 3474450.
PREPARED STATEMENT OF THE COMMISSIONED OFFICERS ASSOCIATION OF THE U.S.

PUBLIC HEALTH SERVICE
INTRODUCTION
The Commissioned Officers Association (COA) of the U.S. Public Health Service
appreciates the interest of this Subcommittee in the very important issue of bioter-
rorism. We are pleased that this Subcommittee recognizes the vulnerability of the
nation to acts of bioterrorism by fringe groups and rogue nations, and is willing to
take a leadership role in seeing to it that the various governmental agencies (local,
state and federal) are asking the necessary questions and taking the necessary steps
to ensure the nation is prepared if the unthinkable should occur.
COA believes the threat of bioterrorism is a serious one, and the Federal Govern-
ment must have a clear, coherent and coordinated plan to deal with potential inci-
dents that could impact upon the safety and health of large numbers of Americans.
COA also strongly supports the enhancement of the Nations public health infra-
structure at all levels of government. In our view, such an effort is necessary irre-
spective of the magnitude of the bioterrorism threat we may face. Too often the bulk
of Federal health funds has been expended for direct health care costs or to support
biomedical research, while Federal expenditures for public health programs have
lagged far behind. Consequently, we would urge this Subcommittee to examine not
only the ability of our public health agencies to respond to bioterrorism, but also
to review their ability to meet the current demands being placed upon them.
THE COMMISSIONED CORPS OF THE U.S. PUBLIC HEALTH SERVICE
In our view any planning that takes place with regard to response to an incident
of bioterrorism must take into consideration the capabilities of the Commissioned
Corps of the U.S. Public Health Service. This view has been supported on a number
of occasions, most recently by Secretary Thompson in testimony before the Senate
Appropriations Committee, Subcommittee on Commerce, Justice, State, and the Ju-
diciary this past May 9th. In that hearing he stated:
In order to advance an orderly and comprehensive approach to the many issues
involved in such preparation (for a bioterrorism event), I will appoint a special as-
sistant within the Immediate Office of the Secretary to lead the departments bioter-
rorism initiative. This person will report to me directly. I plan to call a national
meeting of HHS agencies to evaluate the status of bioterrorism activities and report
back to Congress on our efforts. In addition, the new special assistant will support
the Surgeon Generals efforts to revitalize the Public Health Service Commissioned
Corps and its Readiness Force. Let me assure you that this is a top priority for me
and for my entire department.
Congress has also noted that the Commissioned Corps has much to offer in the
area of bioterrorism. In 1998 the Senate Armed Services Committee, in the Com-
mittee Report that accompanied the Department of Defense Authorization Act for
fiscal year 1999, observed: The Committee notes the efforts underway within the
Department of Defense to develop the means to respond to acts of terrorism involv-
ing weapons of mass destruction. In this regard, the committee directs the Secretary
of Defense to ensure the assessment of needs and capabilities includes an analysis
of the capabilities that exist within the Commissioned Officer Corps of the U.S. Pub-
lic Health Service, who, as members of the uniformed services, might be easily inte-
7
grated into Department of Defense plans to respond to emergencies involving weap-
ons of mass destruction.
The Commissioned Corps has a history of deploying with the military that goes
well beyond mobilization in times of war. In such instances the uniform and rank
structure of the Commissioned Corps, as noted by the Senate Armed Services Com-
mittee, has indeed facilitated the relationship among the services.
This Committee came to a similar conclusion. In the report accompanying the Ap-
propriations Bill for the Departments of Labor, HHS and Education for fiscal year
1999, the Committee stated: In developing plans for bioterrorism countermeasures,
the Committee notes the standing personnel and reserves of the Public Health Serv-
ice are a valuable resource that ought to be well-integrated.
The Commissioned Corps, as a uniformed service, brings some unique capabilities
to the public health and emergency response arenas, making these officers espe-
cially well-suited for the public health response required in the aftermath of a bio-
terrorism incident. As noted in a February 1998 Report prepared by a Special Advi-
sory Committee of esteemed public health professionals headed by Former Surgeon
General C. Everett Koop, . . . expertise which is resident in the Corps to deal with
biological and chemical agents is a critical resource that can be called upon in the
event of terrorist attack. Tab A briefly describes some of the important characteris-
tics of the Commissioned Corps, among them:
public health training and experience;
on call 24 hours a day, like their military counterparts;
available for assignment to accommodate changing public health needs and pri-
orities;
an exceptional track record in the area of emergency response;
presence in 49 of 50 states, with large concentrations of officers in nearly every
region of the country, thereby allowing for an expedited response.
The Commissioned Corps is also a rich source of epidemiologists whose expertise
will be critical as part of a bioterrorist response.
In August 1997 Minnesotas former governor, Arne H. Carlson sent a letter to
then-DHHS Secretary Shalala praising the outstanding assistance provided by Com-
missioned Corps task forces to the citizens of Minnesota in the aftermath of the dev-
astating spring floods. Governor Carlson noted that one of the lesser publicized, but
serious impacts of the flooding was an estimated 2500 flooded private wells, requir-
ing the restoration of safe water supplies for many of Minnesotas citizens. He ob-
served that (t)he three task forces entered the state fully equipped and thoroughly
organized to operate with a minimum of state involvement, and they brought the
long, dirty and sometimes dangerous work to a successful conclusion in six weeks.
Tab B further details the emergency response capability of the Commissioned Corps
based upon actual experience since the late 1980s.
One special component of the Commissioned Corps (cited by Secretary Thompson
in his May 9th testimony before the Senate Appropriations Committee, Sub-
committee on Commerce, Justice, State, and the Judiciary) is the Commissioned
Corps Readiness Force (CCRF), which was created by the Office of the Surgeon Gen-
eral in 1994 to improve the DHHS ability to respond to public health emergencies.
The CCRF is a cadre of nearly 1500 PHS active duty officers who are uniquely
qualified by virtue of their education, skills and experience to respond to public
health emergencies, and who can be mobilized quickly for this purpose.
The Commissioned Corps is also a vital part of the Nations emergency response
capacity through its role with Disaster Medical Assistance Teams (DMATs), which
consist of both federal and private sector personnel. One of these DMATs (PHS1)
is comprised primarily of Commissioned Corps Officers (approximately 80 percent).
This team has been stationed at high profile national events to provide the initial
public health response in the event of a bioterrorism incident.
In 1999 the first National Symposium on Medical and Public Health Response to
Bioterrorism was held in Arlington, VA. During a panel discussion of a smallpox sce-
nario, Mr. Jerome H. Hauer, then Director, Office of Emergency Management, New
York City, stated that in the event of a smallpox outbreak in New York, he would
require hundreds of investigators in the metropolitan area. In addition, he noted the
requirement for personnel to provide smallpox vaccinations, observing that the vac-
cination process is complex, and the average health care provider is not trained in
this area.
Mr. Hauers needs can most certainly be met by the Commissioned Corps. With
hundreds of public health professionals stationed within a short drive of New York
City, a rapid response can be achieved. The variety of locations nationwide where
Commissioned Corps officers are stationed permits the mobilization of a large num-
ber of Commissioned Corps officers anywhere in the country in a very short period
of time. Furthermore, with some improvements to the administration and training
8
of the inactive reserve component of the Commissioned Corps (discussed below), an
additional response capacity, or a backfill capacity, as circumstances require can be
made available. The medical expertise also resides within the Commissioned Corps
to staff alternate care facilities as needed (e.g. hospitals to handle small pox cases).
While the Commissioned Corps is currently the best available source of public
health expertise, a few modest initiatives will make it even better. Some of the ini-
tiatives may require legislation, while others may simply require policy changes
within the Department of Health and Human Services. Clearly, however, oversight
from this Committee is crucial to ensure that the necessary steps are taken. The
following are some of the actions that would enhance the ability of the Commis-
sioned Corps to respond to a bioterrorism incident:
Clarification of the ability to mobilize the Commissioned Corps under a single
operational control in the event of an incident involving a weapon of mass de-
struction.The Surgeon General, the uniformed leader of the Commissioned
Corps, administers the Corps and as such is responsible for formulating Com-
missioned Corps policy. However, Commissioned Officers are assigned to agen-
cies both within and outside the Department of Health and Human Services.
This diversity in assignments is a clear advantage, and one of the great
strengths of the Commissioned Corps. However, those agencies to which officers
are assigned retain significant control over the work performed by their officers.
There should be no question that the Surgeon General has authority to direct
all PHS officers to respond to a bioterrorism incident, regardless of the agency
to which the officers are assigned.
Provide additional training.The public health background these officers bring
to the bioterrorism scenario is a significant advantage. However, it is important
that, as in any specialized area, the officers receive ongoing training to develop/
maintain their expertise.
Formalize the Inactive Reserve program.This issue was touched upon above.
Unlike the inactive reserve components of the other services, the Commissioned
Corps program has been run on an informal basis, with a somewhat loose affili-
ation by the members. Nearly all members of the PHS inactive reserve have
served at least two years on active duty and thus are familiar with Federal pro-
grams and procedures. The potential of this program has been recognized by
many in Congress, including the House Appropriations Committee that directed
a study to ascertain the viability of establishing an Office of Reserve Coordina-
tion to administer the program. Without question the inactive reserve program,
and public health in general, could be dramatically enhanced if even modest re-
sources were committed to the maintenance of the reserve program and to the
training and utilization of inactive reserve officers.
Once again, the Commissioned Officers Association very much appreciates this op-
portunity to submit its views to this distinguished Subcommittee. We look forward
to addressing further details of these and other issues with you and the Sub-
committee staff.
PREPARED STATEMENT OF THE ASSOCIATION OF STATE AND TERRITORIAL HEALTH

OFFICIALS
The Association of State and Territorial Health Officials (ASTHO) appreciates this
opportunity to provide comments to the U.S. Senate Subcommittee on Labor, Health
and Human Services, and Education Appropriations on public health preparedness
particularly for potential terrorist attacks using biological or chemical agents.
ASTHO represents the state and territorial public health agencies of the U.S.
states, the U.S. territories, and the District of Columbia. ASTHOs members are the
chief executive officers of the health agencies of these jurisdictions. In response to
the tragic events of September 11, ASTHO has established an Anti- terrorism Pre-
paredness Task Force to provide expert information and advice on relevant pre-
paredness policy and programmatic, and legislative priorities.
For years, public health professionals have identified the need for strengthening
the United States public health infrastructure as a major national issue. Public
health surveillance capabilities provide an early warning system for our nation.
However, challenges such as emerging infectious diseases continue to tax this sys-
tem. The terrorist events of September 11 have further shown that disaster pre-
paredness and strengthening the public health systems ability to identify and re-
spond to such disasters must be a top national priority.
Within the past few days, members of Congress have proposed appropriations in
excess of $1.6 billion to improve the nations bioterrorism preparedness, with a
major portion of those funds devoted to critical public health response programs
9
through state and local health agencies. We fully endorse this proposed allocation
as a critical down payment for future vigilance against a tragic threat that is here
to stay.
Ten days after the September 11th tragedies, ASTHO produced a special closed
circuit satellite telecast to discuss public health infrastructure in the context of
emergency preparedness. The conference, moderated by ASTHOs President Dr.
Georges Benjamin of Maryland, featured presentations from state health commis-
sioners in several of the affected states (E. Anne Peterson, MD, MPH, Virginia;
George T. DiFernando, Jr., MD, MPH, New Jersey; and Robert S. Zimmerman, Jr.,
Pennsylvania); HHS Deputy Secretary Claude Allen; Jeffrey Koplan, MD, MPH, Di-
rector of the Centers for Disease Control and Prevention (CDC); and Elizabeth M.
Duke, Ph.D., Acting Administrator of the Health Resources and Services Adminis-
tration (HRSA). The discussion focused on the public health response to the terrorist
events: the successes, challenges, and unresolved issues. Dr. Koplan listed seven
critical areas of public health capacity that must be strengthened to ensure national
preparedness against a biological or chemical threat:
(1) public health workforce;
(2) laboratory capacity;
(3) epidemiology and surveillance;
(4) secure and accessible information systems;
(5) communication;
(6) effective policy and evaluation; and
(7) preparedness and response capacity.
We believe these key areas are absolutely essential to preparedness planning and
require additional resources to assure their availability. States are at different
stages of preparedness in each of these seven critical areas. Therefore the states will
have different priority needs.
In addition, resources and leadership are needed at the federal level to support
state planning and coordination and development of a national strategy for pre-
paredness. We encourage Congress to utilize and build upon the expertise, experi-
ence, and leadership that CDC has demonstrated in recent years in developing our
nations public health response to bioterrorism.
CRITICAL RESPONSE AREAS
Public health workforce

A well-trained, fully prepared public health workforce is the foundation of our
public health system. The public health workforce includes a range of disciplines
such as physicians, nurses, dentists, social workers, nutritionists, environmental
health specialists, epidemiologists, veterinarians, laboratorians, health educators,
disease investigators, and outreach workers. These professionals work to improve
the publics health through prevention, education, research, and policy development.
The current public health workforce is not sufficiently trained to meet the growing
needs of emerging infectious diseases, new vaccines, and more far-reaching preven-
tion efforts, in addition to planning for potential threats of terrorism or emergencies
such as a global pandemic influenza. A Status Report recently prepared by CDC on
the Public Healths Infrastructure indicates that as of 1997, 78 percent of local
health officers did not have graduate degrees in public health.1 Moreover, many
public health professionals lack opportunities for continuing education in their fields
due to insufficient budgets, staff shortages, and proximity to education and training
programs.2 If we are to be fully prepared to respond, these trends must be reversed.
The Status Report also shows that the governmental portion of the public health
workforce includes nearly 500,000 professionals deployed at the local, state, and na-
tional levels. With the increasingly complex patterns of disease, interventions, tech-
nology and partnerships; advanced education and training are becoming increas-
ingly important.3 At the same time, hiring freezes and low salaries have hindered
the ability of health agencies to recruit and retain talented public health officials.
The average tenure of a state health official is less than two years.
Laboratory capacity
Active surveillance depends on the ability of the public health laboratory to rap-
idly and accurately analyze and identify samples submitted to them for analysis.
For example, in 1997, the Colorado State Public Health Laboratory was responsible
1 A Status Report, Public Healths Infrastructure prepared for the Appropriations Committee
of the United States Senate by the Department of Health and Human Services and the Centers
for Disease Control and Prevention, 2000.
2 Ibid.
3 Ibid.
10
for determining that an outbreak of E. coli O157: H7 had occurred and that con-
taminated hamburger patties were the source of infection. Their rapid response pre-
vented serious cases of hemolytic uremic syndrome that frequently result from this
infection from occurring across the nation as a result of the largest recall of con-
taminated meat products in our nations history.
Public health laboratories are ideally suited for the critical role of identifying bio-
logical agents. Unfortunately, some state public health laboratories are not equipped
to detect the most likely biological agents such as anthrax and smallpox. State lab-
oratory facilities need to be upgraded with appropriate equipment and trained per-
sonnel.
Laboratory personnel in all 50 states and territories should have access to ad-
vanced training in both the identification of bioterrorist agents, using the newest
detection techniques, and in handling the agents safely. Responding to these issues
is not a short-term proposition. Laboratory support for public health programs re-
quires ongoing investment in new techniques, new equipment, methods development
and documentation, staff training, and quality assurance procedures.
Another related issue pertains to the need to train hospital and private clinical
laboratory personnel to recognize an unusual pathogen, a critical public health role
in emergency preparedness. The importance of timely detection cannot be over-
emphasized. In the case of many biologic agents, the time lag between exposure to
the pathogen and the onset of symptoms may vary from hours to weeks. An effective
response will depend jointly on the ability of the clinician to identify and accurately
diagnose an uncommon disease or toxic response and on a surveillance system for
collecting and organizing information from clinicians and laboratories.
Three excellent programs currently exist within CDC to enhance laboratory capac-
ity and coordination but not all states receive funding to support these efforts.
ASTHO recommends enhancement of these programs: the Laboratory Response Net-
work, the National Laboratory System, and the development of a Chemical Ter-
rorism Preparedness program to include all states.
Epidemiology and surveillance
Epidemiology and surveillance programs of state health agencies detect outbreaks
of common diseases or rare occurrences of unusual diseases. Epidemiological inves-
tigation determines when and where the exposure took place and whether cases are
still occurring. To conduct such surveillance, state health agencies need adequate
numbers of epidemiologists trained to recognize both natural and intentional events
and to institute appropriate measures to control them.
In additional to trained personnel, there is also a need for electronic reporting ca-
pabilities. An electronic disease reporting system enhances state and local surveil-
lance partnerships which are critical throughout the detection and response process.
An electronic system would connect reporting entities, such as hospitals, private lab-
oratories, physician offices and local health agencies with state and national public
health officials. Such systems require not only technology but also support in the
areas of technical support persons, hardware, and software.
Secure and accessible information systems
The ability to rapidly communicate with state and local health agencies is critical
in responding to bioterrorist and infectious disease outbreaks. Rapid communication
was an essential component of the coordinated response to the September 11 attacks
in Virginia, New York, and Pennsylvania.
All states need state of the art computer systems with high speed Internet access.
Satellites for distance learning are essential and videoconference capability is also
greatly needed to improve the ability to disseminate information routinely and in
the event of an emergency. Information is only as reliable as the data management
that supports it. Upgrading information systems is an ongoing challenge. Many
states analyses of their data systems show major gaps in infrastructure. Weak-
nesses exist particularly in linking databases, in assuring the security necessary to
increasing web applications, and in interactions with the provider community, the
source of much public health data. Three systems have been developed by CDC to
begin to address the aforementioned gaps; however, these systems are not fully im-
plemented.
The first of these three systems, the Epidemic Information Exchange (Epi-X), was
designed to instantly notify public health practitioners of urgent public health
events and request assistance from CDC on- line. Epi-X assists bioterrorism pre-
paredness efforts by providing a secure communication channel for public health of-
ficials. Future enhancements of the system include providing secure communications
for multi-state outbreak-response teams, links between disease surveillance pro-
11
grams and the Health Alert Network, and improved software to automate the rec-
ognition of similar disease outbreaks across jurisdictions.
The National Electronic Disease Surveillance System (NEDSS) assists in the man-
agement of surveillance systems and allows the public health community to respond
more quickly to public health threats. When completed, NEDSS will electronically
integrate and link together a wide variety of surveillance activities and will facili-
tate more accurate and timely reporting of disease information to CDC and state
and local health agencies. To accelerate NEDSS deployment, additional resources
are needed to strengthen state data security infrastructure, fast-track the avail-
ability of the NEDSS Base System, and enhance NEDSS functionality at the state
level.
The Health Alert Network serves as the backbone for the public health commu-
nication strategy developed by CDC. This network will ensure communications ca-
pacity at all local and state health agencies. The Health Alert Network was oper-
ational 24 hours per day, seven days per week during September 11 to September
28 to provide critical information to state and local health agencies about the re-
sponse and recovery activities associated with the terrorist attacks. Additional re-
sources are needed to accelerate the development, coordination, and full implemen-
tation of these systems.
Communication
The importance of effective communication in times of emergencies cannot be
overstated. Just as states and local health agencies need effective information sys-
tems, they also need up to date information and appropriate messages to share.
Health officials are on the front lines and their message and communication ap-
proach will not only coordinate response, but will also reassure a fearful public.
Communication channels must be established before an emergency takes place,
and must be inclusive of all partners involved in the response. Rapid, reliable infor-
mation and communication among federal, state, and local public heath authorities,
health care delivery systems, police, firefighters, emergency management services
(EMS), emergency personnel, and others is essential.
Effective policy and evaluation
The events of September 11 have served to increase our understanding of the
need for sound public health policy. Issues of conflicting legislative and regulatory
provisions across state lines could impede the ability of public health to respond to
critical health needs in the event of a bioterrorist event. The ASTHO Task Force
on Anti-terrorism Preparedness will help identify many of the specific issues en-
countered during the days after the tragic events and will be prepared to make rec-
ommendations as to policy and even legislative needs in this regard in the near fu-
ture.
CDC, in partnership with ASTHO, the National Association of County and City
Health Officials (NACCHO), the National Association of Local Boards of Health, the
Public Health Foundation and the American Public Health Association, has devel-
oped the National Public Health Performance Standards Program. Three assess-
ment tools have been designed specifically for state and local health agencies and
local boards of health. These assessment tools provide performance measures by
which the public health system, including public and private partners who con-
tribute to the publics health, can be evaluated.
Specific to bioterrorism preparedness evaluation, the Bioterrorism Preparedness
and Response Core Capacity Project, which is co-chaired by CDC, ASTHO and
NACCHO, is in the process of identifying core capacities for bioterrorism and emer-
gency response preparedness.
States also have taken steps to evaluate their public health systems. For example,
Washington State has begun to assess how well prepared its public health system
is to respond to a major public health threat or emergency. The state has developed
and tested performance standards for the public health system, evaluating how well
its 34 local health jurisdictions and state department of health can perform in five
key areas of public health practice. The state has also established a baseline assess-
ment of county-level preparedness capacities examining the processes, procedures,
and relationships necessary to effectively detect and respond to public health emer-
gencies. This is typical of the types of exercises underway in other states.
Preparedness and response
Successful preparation for weapons of mass destruction emergencies will depend
on the development of a well-orchestrated plan to be used in responding to an event.
The implementation of that plan will vary, depending on the nature of the attack.
If the incident involves biological agents, public health officials as well as emergency
room personnel and critical care unit personnel will be key players and first re-
12
sponders. If the incident involves chemical or explosive agents, public health offi-
cials would be complementary to the management of the emergency. Regardless of
the nature of the attack, the responsibilities of public health officials will include
identification of existing assets and assessment of needs, resource allocation for pre-
paredness, stockpiling of supplies, medical training for treatment, and communica-
tion with the public.
Planning and coordination
Planning and coordination go hand in hand with all areas previously mentioned.
If the response to a biological threat or chemical attack has not been well planned,
it carries the potential of being ineffective. States are currently working to better
define and test the roles of various entities, including local health agencies, state
laboratories, emergency responders, hospitals, and others to establish policy to ad-
dress unexpected events. Pre-emergency response planning forges better commu-
nications between public health and emergency response sectors, which in many
states operate independently. Improvements in infrastructure made now to address
the major elements of emergency preparedness planning can have immediate and
lasting benefits.
Emergency planning for bioterrorism requires special emphasis on certain func-
tions not normally included in disaster plans. Examples include special surveillance
operations, delivery of vaccines and antimicrobial agents, and other mitigation ef-
forts. The widespread nature of adverse health effects due to the disruption of crit-
ical human infrastructure will require the expansion of the typical disaster manage-
ment team. Public health officials bring essential contributions to such strategic
planning teams.
National strategy
There is sufficient crossover and concurrence in each of these seven areas to ne-
cessitate appropriate coordination at the national level. In the event of a bioterrorist
event, the magnitude of the problem, essential treatment and prevention measures,
and environmental impact are continually assessed. If an infectious agent is in-
volved, public health officials may have to house ill individuals in isolation units in
hospitals, or in make-shift facilities, attended by medical personnel who are pro-
tected by specialized clothing, or who have received advance immunization. Public
health officials may also be forced to place a large number of individuals in quar-
antine and temporarily close large public gathering places and transport centers.
Massive distribution of stockpiled vaccine and medical treatments such as anti-
biotics will also be necessary. Assurance of safe food and water supplies will be es-
pecially critical. These are just a few of the many issues that require a strong na-
tional strategy.
Addressing the threat of smallpox and anthrax
The threat of a terrorist attack using smallpox remains unlikely, but health offi-
cials recognize that it is prudent to be prepared. It is important to move as rapidly
as possible to accelerate production of smallpox vaccine. In addition, a plan should
be developed outlining the appropriate course of action in the event of a smallpox
attack, including the use of vaccine. Planning and resource allocation must be un-
dertaken to ensure that vaccine delivery and administration and other appropriate
actions are immediate, efficient, and effective.
ASTHO makes this recommendation on the basis of the following assessments: (a)
while the probability of such an event appears low, a smallpox attack by terrorists
is nonetheless a credible possibility; (b) the threat of smallpox is a threat that we
do have the ability to substantially mitigate or even abrogate through effective use
of vaccine; (c) smallpox is a threat for which there are really no good alternatives
to vaccination for effective response; and (d) smallpox is a threat that carries the
potential for great harm and global spread if there is not an effective response.
ASTHO also encourages expeditious exploration of methods to provide protection
to civilian populations in the event of terrorist use of anthrax. ASTHO encourages
CDC to develop rational, reasonable, and balanced communications tools concerning
smallpox and anthrax which are suitable for the general public and can be shared
with all state health agencies. ASTHO encourages Congress to provide additional
resources as needed to support these recommended activities.
Conclusions and closing recommendations
The Department of Health and Human Services, through CDC, has been leading
the effort to upgrade national public health capabilities to address any potential bio-
terrorist event. CDC has initiated a cooperative agreement program for state and
major local health agencies to help upgrade their capabilities. Eligible applicants
can request support under the following five focus areas: Preparedness Planning
13
and Readiness Assessment; Surveillance and Epidemiology Capacity; Laboratory Ca-
pacity-Biologic Agents; Laboratory Capacity-Chemical Agents; and the Health Alert
Network. These funds have enabled state and local health agencies to link and inte-
grate their preparedness activities and local and county preparations for crisis and
consequence management of a terrorist event. ASTHO commends the Congress for
making these resources available. However, all states are not funded in all areas
and additional resources are urgently needed to address the concerns outlined in
this document.
ASTHO urges the Subcommittee to assure that:
The federal government assumes an appropriate leadership role in strength-
ening the national public health infrastructure and capacity;
The federal government makes the necessary resources available for public
health workforce training, preparedness planning, and readiness assessment at
the state and local health agency level to assist in the development and imple-
mentation of plans to address public health issues following a biologic or chem-
ical terrorist attack;
Public health agencies at the local, state and federal levels are sufficiently en-
hanced to detect, monitor, and contain disease outbreaks. Rapid detection of a
biological attack can prevent a local epidemic from becoming a national epi-
demic;
Sufficient resources are provided to develop medical counter-measures against
a bioterrorist attack, including funding to speed up vaccine production and to
stockpile antibiotics; and
Our nations hospitals are properly equipped and health professionals are prop-
erly trained to respond to bioterrorism.
The public health system is the vital link in our ability to preserve and protect
human life when disaster strikes. Services we all count on must be present in the
event of a major epidemic, a bioterrorism incident, exposure to a chemical hazard,
radiological release or contamination of food and water supplies. We thank the Sub-
committee for its understanding of the vital importance of a national policy and ap-
propriate resources to strengthen public healths capacity to identify and respond to
bioterrorist events, and its recognition that by doing so, public healths overall ca-
pacity to protect our nations health and well-being will be enhanced.
We look forward to working with the Subcommittee to assure the availability of
the critical funding needed to address each of these urgent issues.
Senator HARKIN. Before I turn to our first panel, I will yield to
our distinguished ranking member, Senator Specter, for his open-
ing remarks.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator SPECTER. Thank you very much, Mr. Chairman, and

thank you for convening this important hearing, and for your lead-
ership in this important field.
Earlier this week, I held town meetings at Cheney and Lincoln
Universities in Pennsylvania, and one of the key topics on the
minds of the students and faculty there was what would happen
in the case of an attack by biological weapons or chemical weapons.
It is obvious that there is great concern in America today with the
potential for weapons of mass destruction.
When we have seen what the terrorists did on September 11,
there is no doubt that they have the capacity and the evil to render
unlimited damage on America to the maximum extent of their ca-
pabilities, and there is obvious concern that, as well-financed as
they are, and as sophisticated as they are, that they may have bio-
logical and chemical weapons and other weapons of mass destruc-
tion, so this is a matter of the utmost urgency.
The issue is joined today with contrasting viewpoints, with Sec-
retary of Health and Human Services Thompson being quoted ear-
lier this week that the administration was: very confident that we
could act and react to any kind of bioterrorist breakout, and Sec-
14
retary Thompson insisting that the Government: can handle any

contingency right now.
One of our witnesses today is Dr. Steven Cantrill, of the Depart-
ment of Emergency Medicine of the Denver Health Medical Center,
who categorically disagrees, saying: an additional concern is the il-
lusion shared by many that our health care system could ade-
quately deal with a significant weapons of mass destruction inci-
dent.
In this area, I must respectfully disagree with Secretary Thomp-
son, and Dr. Cantrill goes on to say: this problem would only be
partially alleviated by dispatching Federal resources to a specific
locale, and could be of no help if terrorism opted to involve dozens
of metropolitan areas simultaneously.
This subcommittee has responded with almost doubling the fund-
ing for bioterrorism from 1999 through the projections for the year
2002. We find that there is again a fragmentation of our efforts
among the Department of Health and Human Services, the Depart-
ment of Justice, the Department of Energy, the EPA, and emer-
gency response.
We now have a new leader coming into the field later this week,
Governor Tom Ridge, announced as being the Secretary of Home-
land Security, and now there are issues raised as to the scope of
his authority, and a number of us are drafting legislation to try to
put a number of the agencies and resources under his control, like
Border Patrol, Coast Guard, Immigration, and Naturalization, and
a significant hand in intelligence.
Just having an agency in the Federal Government analogous to
the National Security Advisor raises very serious questions as to
whether that is enough authority on this very, very important mat-
ter. In a testimonial to the importance of this issue, we have four
distinguished U.S. Senators here today. That is the most Senators
this subcommittee has drawn in the 21 years that I have been
here, so we know, ipso facto, this is an important subject.
Mr. Chairman, while we are having this hearing, down the hall
there is a Subcommittee on Constitutional Law hearing on ter-
rorism legislation which is probably of equal importance to what
we are hearing today, so I am going to be shuttling back and forth,
but I do welcome our colleagues here today, Senators Kennedy,
Frist, Hagel, and Edwards, and look forward to their testimony.
Thank you.
Senator HARKIN. Thank you. Now I would recognize the distin-
guished chairman of the full Appropriations Committee, Senator
Byrd.
OPENING STATEMENT OF SENATOR ROBERT C. BYRD
Senator BYRD. Thank you, Mr. Chairman. Thank you for holding
this hearing. This is a very important hearing. I have been saying
in the Armed Services Committee for a long time that we had bet-
ter be thinking about chemical and biological weapons being used
against us. While I think that debate was with respect to a nuclear
attack and how a missile shield is important, this is as important,
if not more so. So I congratulate you on holding this hearing, and
I congratulate the ranking member, and these four eminent Sen-
15
ators who are on authorizing committees that are very important

in this battle.
I was just sitting here thinking about the nine plagues of Egypt.
You recall, Moses sought to get the pharaoh to let our people go,
and pharaoh was hard-nosed about it, so God threw Moses and
these plagues upon Egypt. There were nine of them. Let me see if
I can remember them in sequence. First was blood, the rivers
turned to bloodyou can write it down and check me.
Blood, frogs, lice, flies, cattle, boils, hail, locusts, and darkness,
nine plagues, so to translate that into todays language, and into
todays modern life, that would be, I suppose, biological warfare in
that day.
I am concerned about biological warfare. Unlike an explosion, a
cloud of microbes released from a small plane would not trigger
alarm like dropping a bomb. Many of the initial symptoms in hu-
mans could first be mistaken as an ordinary cold or the flu.
Most public health departments dont even have computers to
track diseases, and yet several of the most dangerous biological
warfare agents, plague, anthrax, and others, respond to antibiotics,
so quick detection of an outbreak and rapid availability of drugs
could save numerous lives. It is critical that adequate supplies of
drugs be available, and that plans exist for their efficient distribu-
tion.
Are we ready? We might ask the Secretary when he comes. I
may not be here at that time. I am trying to get these appropria-
tions bills moving, Senator Kennedy. It is like moving a stone up-
hill, but Sisyphus kept trying, and so I will continue to try.
Unfortunately, public health experts believe that the Nation is
currently tens of millions of vaccine doses short to effectively de-
fend against a biological attack, and stockpiles of antibiotics and
other medicine are inadequate. Just go over to Fairfax Hospital
and look at the emergency room. I took my wife over there just a
while back. She had pneumoniawe did not know it was pneu-
moniathen atrial fibrillation. She was in that emergency room all
day, and I was right there with her. They cannot handle it. We do
not have the infrastructure to handle the crowds that come to these
hospitals.
Fairfax Hospital is a great hospital. But they do not have the in-
frastructure. Hospitals have reduced in-patient care in recent
years. They are unprepared to handle large numbers of critically
ill patients. If you have not been there, go over to Fairfax Hospital
or any of the other hospitals in the area. Go to the emergency
rooms. That is where we are likely to go, those of us who are past
80. You have got a long time to wait.
But the administrations belief is that Osama bin Laden and his
Al Qaeda network may already have the means to use chemical
and biological agents as terror weapons. A Department of Defense
report released in January of 2001 indicated that Iraq, Iran, Syria,
Sudan, and Libya all have active chemical or biological weapons
programs.
Now, Mr. Chairman, that completes my statement. Thank you
for conducting this exercise. Were both on appropriations, and so
is Mr. Specter, and the Senators here who are on the authorizing
committees will be talking with us about appropriating. There is no
16
more important problem facing us as appropriators, or as author-

izers, than this one. Enough said.
Thank you.
Senator HARKIN. Mr. Chairman, you really put it succinctly, and
we appreciate you being here and thank you for your leadership on
the full committee in this effort. I know I can speak from having
served on this committee now for 17 years, that I know we can look
to you for the guidance and the leadership necessary to put the
funds out there to make sure we meet this emerging national
threat, and we thank you for your leadership in this area.
As our chairman said, as appropriators we look to our author-
izers for guidance on how we spend this money. Regarding the $20
billion, we look to our authorizers to give us guidance and direc-
tion. We turn now to our distinguished first panel with those au-
thorizers, and first I would recognize Senator Kennedy from Mas-
sachusetts.
Senator Kennedy, along with Senator Frist, introduced the legis-
lation last year which was the Public Health Threats and Emer-
gencies Act. It was passed and signed into law, and basically was
the first step to building up our first line of defense and our basic
infrastructure. Senator Kennedy and Senator Frist, I want to ap-
plaud both of you for being way ahead of the curve on this. You
had the foresight to do it.
So Senator Byrd, I would just say we do have some basic legisla-
tion right now, thanks to Senator Kennedy and Senator Frist, to
which we can look for the guidance on where we would want to put
this money to build up that basic infrastructure.
With that, I want to thank both of you, and we will go in order
of seniority, and I will recognize Senator Kennedy first.
STATEMENT OF HON. EDWARD M. KENNEDY, U.S. SENATOR FROM
MASSACHUSETTS
Senator KENNEDY. Thank you very much, Mr. Chairman. If I
could Id like to submit my full statement in the record. I know the
committee has a full schedule, so we will not take an undue
amount of time.
First of all, I want to thank this committee for their superb
statements that have been made this morning. This is a committee
that has responsibility for allocating resources, and it is quite clear,
not only from the statements this morning but also the actions that
have been taken in the past, particularly in terms of the support
for the research and the development of various vaccines and anti-
biotics, that this committee has been ahead of the curve. That is
why we particularly appreciate the chance to work with the com-
mittee in terms of ensuring that we are going to have adequate re-
sources to try and meet our responsibilities to the American people.
I want to first of all thank my colleague, Senator Frist, and my
other colleagues as well, Senators Edwards and Hagel. Senator
Frist and I embarked on a series of hearings in 1998 on this sub-
ject matter, and into 1999, and developed the legislation in 1999,
and then passed it last year, and we have worked very closely to-
gether. It represented our best judgment and the judgment of the
committee, and I enjoyed working with him.
17
While we worked very closely on this legislation and will con-

tinue to do so, I thank Senator Edwards and Senator Hagel. They
have given with their legislation an additional component in deal-
ing with the agricultural challenge. That was not dealt with in our
committee. We did not include it, but we noted it, and it is an ex-
tremely important aspect which they will speak to, as well as to
their sense of the importance of the legislation.
I want to also thank Secretary Thompson. He has been des-
ignated as the principal lead person for the administration. I have
spent time with Secretary Thompson. He is very familiar with the
General Accounting Office review, as well as other reviews about
the inadequacies of our system, and the GAO has pointed out that
there needed to be a great deal more coordination. There was frag-
mentation between the various agencies. He is addressing that
issue. You will have more of a chance to get into that question.
Also the GAO talks about the various gaps in our system, and I
know you will hear from him on this issue. We address a number
of those components that have been outlined in the GAO report,
and that is why we are glad to be here.
As has been mentioned here, the September 11 terrorist attack
indicates that we may very well face a different kind of attack in
the future, and we are here to mention very briefly at least how
we believe the focus and attention of resources ought to be focused.
First of all, we want to emphasize the area of prevention. The
best way to assure the health and well-being of our citizens is to
prevent a bioterrorist attack. That is going to be done as part of
the administrations overall efforts in terms of the intelligence-
gathering, information-gathering, the penetration of these various
cells, as well as penetrating the free flow of resources that are
going to various terrorist activity. That kind of aspect is underway
at the present time, and it is something that is outside of what we
are going to talk about, but it is of enormous importance.
Second, we take note that as there has been the development of
weapons of mass destruction, both biological and chemical, the
principal source of the storage of this material is in the former So-
viet Union. As we have made important progress with the former
Soviet Union in terms of the storage of nuclear material, we are
very hopeful that the administration is working on assuring that
we are going to have adequate storage in the former Soviet Union
with regards to biological weapons. Also the scientists and re-
searchers that are very much involved in the development of that
program, and a similar kind of a program that has been worked
on in the Nunn-Lugar proposal, could also have application here.
Those are issues for another time, but they are, we believe, of im-
portance.
The three items that I want to mention is, first, the issues of de-
tection, second, the issues of treatment, and third, the issues of
containment. This chart, which is difficult to read, Mr. Chairman,
and then my colleague, Senator Frist, will go into greater details
regarding how these particular features can be addressed in terms
of the appropriations.
The first item, in order to have detection of any attack, is im-
proving the State and local disease surveillance. This is primarily
the public health system. You will see that reflected in the high
18
priorities we give to the public health system. That has been also
a deficient area which has been identified by the GAO.
We have not addressed again the issue of food safety. Secretary
Thompson will. Again, we have a small part of food safety in our
committee. Most of that is in the Agriculture Committee. The
chairman of the committee is very familiar with this issue, but that
is an important part of it.
Next is the upgrading of the capacity of laboratories to identify
biological weapons. There has to be an upgrading at the local level
in terms of detection. That can be done in some parts of our coun-
try. Where it is being done, they have the ultimate in terms of the
cutting edge technologies. We ought to make sure that those kinds
of technologies are going to be available to communities all over the
country.
The first line of defense is going to be in our public health sys-
tem. Our proposal, then, is to improve the detection of an attack.
Second, our proposal will improve the treatment for victims of an
attack. This comes by improving the ability of our hospitals to in-
crease their emergency capacity. As Senator Byrd and others have
pointed out, we have seen a contraction in the number of hospitals.
That has been true in urban areas, it has been true in rural areas.
We have gone in my own State of Massachusetts from 132 hos-
pitals to 84 hospitals over the period of the last 5 years, and we
know that in many of the urban areas people wait out in the cor-
ridors, even to go into the emergency rooms.
This is going to be called upon as the first order of priority.
There are a number of different ways that their assets can be ex-
tended. There is good planning in a number of our great medical
centers about how to do that. We ought to share that information,
but we ought to now have the kind of investment that permits
them to do this in very short order. That is a feature of our pro-
posal.
Next is the development and enhancing of local and Federal med-
ical response. This also includes training. Senator Frist, and many
of us have heard him speak on this, will mention that in all the
times he has been a doctor, in 25 years, he has not been able to
detect smallpox, or has not had smallpox in front of him. We have
to make sure we are going to have the training for the personnel
to be able to detect this. This is training health professionals to di-
agnose and treat the victims of a bioterrorist attack.
Finally, our proposal will improve the containment of an attack
by providing better vaccines to limit the spread of infection, by im-
proving the national pharmaceutical stockpile, and by increasing
research in medications. You will have an opportunity to hear from
the top of our research community. They can give you different
guidance as to what needs help and support, and there are a vari-
ety of different undertakings even at the present time, but as we
understand right at the outset, most of those products do not have
a private market. It is going to take an investment by the Federal
Government, and the Federal Government is going to have to in-
vest in terms of stockpiling those products.
Finally, I would like to just say, Mr. Chairman, the administra-
tion has approximately $350 to $400 million in their budget. Our
budget recommendation is for an additional $1.4 billion. That
19
comes to about $1.8 billion. In terms of our recommendations this

amounts now to about a sixfold increase. Money is not the answer
to everything. We think that this is a prudent and reasonable kind
of investment that can at least start us down the road to meet our
first responsibilities.
The final point I would like to mention, Mr. Chairman, I would
hope as a Nation that we are not going to be frightened by this
prospect. I think that that would be very, very dangerous. We know
that there are individuals that are taking action, as has been point-
ed out. This is a national responsibility, and we would hope that
you are going to deal with it in a responsible way, a serious way,
and a way that underlines the importance of preparation.
PREPARED STATEMENT
Some steps have been taken, other steps are needed, more steps
are needed, a greater investment is needed, but the American peo-
ple ought to understand this is serious. It is dangerous, but at least
we have an understanding about what needs to be done in the very
early stages of it, and that hopefully this committee and the Con-
gress are prepared to make the kind of investment that is going to
be a meaningful down payment to give the kind of protection the
American people deserve.
[The statement follows:]
PREPARED STATEMENT OF SENATOR EDWARD M. KENNEDY
Thank you, Senator Harkin, and thank you also Senator Specter for holding to-
days hearing on this topic of special importanceimproving the nations prepared-
ness for bioterrorism. Your own leadership in providing resources for public health
and medical research has already done a great deal to strengthen the nations pre-
paredness to meet this challenge. Its a privilege to be here today with Senator
Frist.
September 11th was a turning point in Americas history. For two centuries, the
continental United States was spared from foreign attack. The vicious air attacks
of September 11th shattered that security. In the aftermath, we must clearly
strengthen our ability to defend the American people against all forms of terrorist
attacks.
One of the most destructive ways an enemy could attack the nation would be to
use a biological weapon. The difficulty of mounting a biological attack has given the
nation a reprievebut none of us knows how long that reprieve will last.
Over the past two years, Senator Frist and I have held hearings on the dangers
of bioterrorism. As we learned at those hearings, a biological weapon could unleash
destruction on a very broad scale, and we need to be better prepared. A substan-
tially increased investment must be a major part of the nations response, and I am
confident this committee will provide it. This investment is a sound price to pay for
the greater security it will bring to every American and every community in the na-
tion.
Our first priority must be to prevent an attack from ever occurring, and we are
moving quickly to strengthen our intelligence capacity and take other needed steps
to do so.
We also need to work with nations that have stocks of dangerous biological agents
to ensure that they do not fall into the hands of terrorists. Russia currently holds
the largest supply of potential biological weapons. Ive spoken with Secretary
Thompson about the situation in Russia, and I believe theres a real opportunity to
make progress in securing and destroying these dangerous biological materials.
Weve worked with Russia on containing nuclear weapons. Now we must work to-
gether on preventing the spread of biological weapons.
But we must also enhance our preparedness for a bioterrorist attack. Americans
need not live their lives in fear of a biological attack, but building strong defenses
is the right thing to do.
20
If a bioterrorist attack does occur, the keys to responding effectively lie in three
key concepts: immediate detection, immediate treatment and immediate contain-
ment.
Unlike the assaults on New York and Washington, a biological attack would not
be accompanied by explosions and police sirens. Instead, terrorists could release a
lethal bioweapon in a crowded shopping mall or subway station. They might expose
millions to the deadly microbes by spraying a biological weapon over a city.
In the days that followed, victims of emergency room, complaining of mild fevers,
aches in the joints or perhaps a sore throat. Doctors need to be well aware of the
symptoms of a bioterrorist attack, or precious hours will be lost as doctors try to
diagnose their patients.
In Boston, a recently installed electronic communication system would allow phy-
sicians to report unusual symptoms rapidly to local health officials so that an epi-
demic could be identified quickly. Too often, however, as a CDC report has stated:
Global travel and commerce can move microbes around the world at jet speed, yet
our public health surveillance systems still rely on a Pony Express system of paper-
based reporting and telephone calls.
In addition, public health laboratories need the training, the equipment and the
personnel to identify anthrax, plague, smallpox or other potential biological weapons
as quickly as possible.
Emergency care facilities will also be essential. Boston, New York and a few other
communities have plans to convert National Guard armories and other public build-
ings into temporary medical facilities, and other communities need to be well pre-
pared too. Even cities with extensive plans need more resources to ensure that those
plans will be effective when they are needed.
It has been an honor to work with Senator Frist on legislation to enhance the
countrys preparedness for bioterrorism. Congress enacted that initial legislation
last November, and it has already served one of its intended purposes. That legisla-
tion gave the Secretary of HHS the authority to act decisively to protect the public
health during a bioterrorist attack or other health emergency. Secretary Thompson
used this new authority wisely to send medical supplies and personnel to New York,
where they were so urgently needed, and I commend him for his prompt and effec-
tive action.
To improve detection, treatment and containment of a bioterrorist attack at the
state and local level, the legislation authorized investments in disease surveillance,
food safety, and new research initiatives to diagnose such attacks. The Act also
called for new investments in hospital preparedness, so that medical facilities will
have the planning and resources needed to assist victims. To improve containment,
the legislation called for federal supplies of vaccines and antibiotics to be available
quickly to assist local public health officials in containing an epidemic. Federal
stockpiles of vaccines and antibiotics will be essential to contain any outbreak and
save lives.
Under the leadership of Secretary Thompson and Secretary Shalala, much has
been done to improve the nations readiness. We are better prepared now, but we
need to be even more prepared. Senator Frist and I look forward to working with
our colleagues on this committee and in Congress to achieve these extremely impor-
tant goals.
Senator HARKIN. Senator Kennedy, thank you for your very, very
strong statement, and thank you for your leadership on this issue
in getting the legislation passed last year.
Now we turn to the cosponsor of that legislation, who has been
a great source of information and guidance for all of us here in the
Senate because of his strong medical background, and that is Sen-
ator Frist from Tennessee.
STATEMENT OF HON. BILL FRIST, U.S. SENATOR FROM TENNESSEE
Senator FRIST. Thank you, Senators Harkin, Specter, and col-
leagues for holding this hearing on what is a pressing challenge for
us all, and one of the most disturbing issues of our time, given the
events of September 11, and that is the threat of germ weapons
being used by terrorists.
Let me open by saying we are all walking a fine line in terms
of both the potential for being alarmist, and at the same time lay-
21
ing out the information that is important for us to recognize in

terms of our vulnerability as a Nation and as a people. The threat
is real. There is no question about that. The overall probability is
low. Nobody can give a number. There is uncertainty around the
number, but it is low, yet is increasing. Given the events of Sep-
tember 11, I believe that it is increasing quite dramatically.
Bioweapons, germ weapons have huge consequence, much, much
further than anything than we have ever seen in recent humanity,
where we are talking about the potential destruction of millions,
not thousands, not hundreds, not tens, and we are highly vulner-
able. Again that is where we have to be very careful in terms of
saying how vulnerable are we, but we are vulnerable not because
we are unprepared today, and we will hear over the course of the
day that in many ways we are very, very prepared, and have made
tremendous progress, but that we are underprepared, and that
there are certain gaps that we have a responsibility at this junc-
ture to address.
We will hear a lot from respected experts a little bit later in the
subsequent panels, but I think the message that I would like to
leave is the following, and that is that as Nation, with respect to
germ weapons in the hands of terrorists whose stated goal, and we
know that today, and we did not know that quite as well a year
ago, whose stated goal is to cripple the United States of America,
that we are vulnerable not because we are unprepared, but because
we are underprepared, and it is our responsibility to identify those
gaps and to fill those gaps, to reduce that vulnerability.
Now, if our goal is to eliminate those gaps, it is important for
this particular committee to address which gaps are significant,
and in doing that, I would encourage you to look at least at what
we started with in 1999, as Senator Kennedy laid out, and that is
the Public Health Threats and Emergencies Act of 2000, because
our specific purpose at that point in time was to develop a strategy
and a framework that reflects coherency and comprehensiveness in
terms of a national defense policy.
It does this in addressing three different areas. One is preven-
tion. Senator Kennedy spoke to the importance of that. The second
is preparedness, how ready are we, and what is the responsibility
there, and then the response, and these can be looked at discretely,
but clearly work in an interrelated fashion.
Why do I say the threat is increasing? Why do we act now, and
why do we put such figures as $1.4 billion in addition now? The
threat is increasing. If we look, Osama bin Laden has had public
pronouncements that acquisition of biological and biochemical
weapons of mass destruction are a religious duty of his. We know
that now. We have not focused on it, but we know that now.
Coupled with that is that just 3 weeks ago he used something
we had never thought about as a weapons of mass destruction, and
that is an airplane loaded with fuel. He has the money, again
something new. We know that he has money, and we know that
technology is out there, available.
Senator Kennedy mentioned that during the 1980s the Soviet
Union for that whole decade has more than 7,000 scientists work-
ing full-time on developing bio weapons that could be used for de-
structive purposes.
22
Second, the threat has increased because of technology, and you

will hear different people in the third panel talking about the tech-
nology there. Let me just say, from a hospital standpoint we use
nebulizers all the timewe did not have them 15 years agoto
aerosolize sprays. Perfumes are being aerosolized all the time. We
know that from department stores. The aerosolization is just an ex-
ample of how increasing technology has made it possible to dis-
tribute and deliver these biochemical, biological weapons, these
germs in a way that just was not possible 10 years ago or 15 years
ago.
The third issue is that issue which Senator Kennedy mentioned,
is that the expertise is out there, there is no question about it.
Even since the 1980s the science, in terms of genetic recombinant
issues, genetic engineering, it is there today, and if it is not there
today, it will be there within 6 months or a year. In certain areas
the expertise is out there. It is out there probably to the highest
bidder.
What we have done is propose an additional $1.4 billion specifi-
cally, not to cover everything, but when you look at some of the list
you will say, you are all over the place. But look at the original
framework of prevention, preparedness, and response, and you will
see that we are really putting that increased funding where gaps
have been identified.
We will hear again differing opinions about how prepared are we
at the Federal level. In certain areas, we are very prepared, but
without that local front line surge capacity at the hospitals, physi-
cians who can recognize that rash which they have never seen, or
never been trained to recognize before, or that cough, or that flu
illness coming in being presented, out of the last thousand cases
you have seen zero pneumonic plague, or pneumonic anthrax, to
raise that bar up, if you cannot recognize it and detect it in an ex-
peditious way, no matter how good the Federal response is, no mat-
ter how much money is spent at the Federal level, unless you have
this vertical integration of Federal, State, and local coordination, it
does not do any good. It does not do any good.
Now, very quicklyand again, we do not need to go through
what we have done overall, but regarding prevention, there are
three areas. First, regarding intelligence, we have got to know who
has access to things such as smallpox, anthrax, the more naturally
occurring things like tularemia, and the nerve toxins that are out
there.
The issue of food has been mentioned and must be mentioned
once again, and there are many people who think, we all know, we
have underinvested in food safety. We have fewer than 1,000 in-
spectors, 56,000 sites out there where we need to be doing inspec-
tions. We only inspect about 1 percent of the food that is imported
into this country. We have underinvested in the past, and you will
hear more about that today. It absolutely must be addressed.
The third area as we look at prevention is this whole area of re-
search. If we do not have a cure for smallpox, and smallpox has a
40 percent mortality rate today, and if we do not have a cure for
that, we do have to invest in research so that we will have
antiviral therapy. Anthrax has a 100 percent mortality rate if un-
treated, and as Senator Byrd pointed out, it has to be treated in
23
the first 24 hours, so you have to be able to detect itafter 24

hours. We dont know that the vaccines that we have today are
going to be entirely as good as we think, and we need a second gen-
eration that will have the advantages that we know will protect.
The second issue of preparedness, again I do not need to go into
too much, because we hear a lot about it at the Federal level. At
the Federal level we are doing very well, I think, compared to 3
years ago. We can clearly do more. Most of the bulk of the funding
of the more than $1 billion that we are saying should be put into
the system is at the State and local level of preparedness, looking
at medical surveillance, looking at medical epidemiology, address-
ing the issues of fax machines, Internet connections, so when one
public health institution or unit identifies a rash which they sus-
pect to be something, they can at least communicate broadly.
The last areaand we will hear more about stockpiling, I want
to mention is this issue of stockpiling again. We have done very
well. We hear about how well we have done, but clearly we have
a long way to go in terms of having an adequate response at the
stockpiling level. We have specific funding in for that stockpiling,
and to improve that stockpiling so we can really give the security
to the American people that they deserve.
In closing, let me just say that I think our most significant fail-
ure in this country as we look at this coherent strategy of preven-
tion, of preparedness and response, is the lack of investment in our
public health infrastructure. Our public health infrastructure is the
front line. Without the front line, nothing else can click. Nothing
else can work. That is the huge gap that we have underinvested
in.
The good news about it, it is dual use. If we do not ever, and I
pray that we do not ever see a chemical or bioterrorist attack in
the United States, if we never see that, it is dual use investment,
because at the same time you are investing in that public health
infrastructure you are addressing the potential for a flu outbreak,
a flu epidemic, better treatment for HIV and AIDS, and the other
viral illnesses are out there.
PREPARED STATEMENT
Mr. Chairman, we sort of laid a template in the bill that we put

forth last year that is now the law of the land. I would encourage
this committee to use that as part of a coherent strategy as we go
forward, in view of what I would argue is an increased threat of
a bioterrorist attack. I think that we now need to identify those pe-
culiar gaps that are out there, mainly at the State and at the local
level, fill those gaps, and by doing that we will move from our
underprepared state to a prepared state.
Thank you.
PREPARED STATEMENT OF SENATOR BILL FRIST
Thank you, Senators Harkin and Specter, for calling todays hearing on one of the
most pressing and disturbing issues of our timethe threat of germ weapons used
by terrorists. That threat is real. Although the threat has low probability, I would
argue strongly that there is an increasing probabilitywith huge consequences.
Today, we remain highly vulnerable.
24
You will hear from respected experts on these particular issues shortly. I will
focus my comments on the following simple message: As a nation, with respect to
biological weapons, we remain highly vulnerable, not because we are unprepared,
but because we are under-prepared.
You will hear shortly from Secretary Thompson about the tremendous advances
made by the Department of Health and Human Services over the past three years.
Although we have made significant progress, there are still large gaps in our cur-
rent approach. Our goal should be to eliminate these gaps and reduce the risk to
our nation and our people.
Part of the progress that has been made is tied to crucial legislationthe Frist-
Kennedy Public Health Threats and Emergencies Act of 2000, a law which pro-
vides the strategy and framework for a coherent national biodefense policy. This bill
addresses bioterrorism from three discrete but interdependent vantage pointspre-
vention, maximizing our preparedness, and response.
With this framework in place, we can identify shortcomings within our ability to
prevent, to prepare, and to respond. As a critical first step, Senator Kennedy and
I are strongly recommending today that Congress work together with the Adminis-
tration to provide sufficient funding for the priorities specifically established in the
Public Health Threats and Emergencies Act. Just a few months ago, Senator Ken-
nedy and I wrote the members of this Committee earlier this year, requesting full
funding for our legislation. Today, we outline what additional steps should be taken
in light of the September 11 attacks.
The threat of a bioterrorist attack is still remote, but it is higher today for a vari-
ety of reasons. First, Osama bin Laden has publicly pronounced that it is his reli-
gious duty to acquire weapons of mass destruction, including chemical and biological
weapons. He has shown his disregard of human life, using weapons of mass destruc-
tion that we had never envisioned. Furthermore, he has the resources and motiva-
tion to use germ warfare.
Additionally, the threat is increased because of the recent scientific and techno-
logical advances. Rapid advances in agent delivery technology such as aerosolization
have made weaponization of germs, such as anthrax, much easier. Finally, the ex-
pertise of scientists expert in germ warfare is available. Through the 1980s, over
7,000 scientists in the Soviet Union were part of a committed program to create and
maximize the effectiveness of bioweapons. With the fall of the Soviet Union, these
experts are unemployed and soliciting their expertise around the world.
Now that we are all aware of this potential threat, we must concentrate on our
response and invest approximately $1.4 billion specifically to fill the gaps in our cur-
rent biodefense and surveillance system. We must take necessary actions to prevent
the use of bioweapons, prepare our communities, and improve our capacity to re-
spond. We have shared these documents with the subcommittee and I ask that
these documents be included in the record following my statement.
PREVENTION
Our first national priority must be enhanced on-the-ground intelligence to know

who has access to and is capable of deploying biochemical agents, which will require
increased investment for general intelligence capabilities. Much of that work is al-
ready being done within the Department of Defense, in an effort to significantly in-
crease our human intelligence capabilities. Within the Department of Health and
Human Services, however, we must increase international surveillance and coopera-
tion activities. With this investment, we can enhance our intelligence capabilities to
monitor other countrys bioterrorism capabilities; improve coordination of inter-
national surveillance activities; and reduce threats posed by the former Soviet
Union.
Bioterrorism has been successfully used only one time in our country and that
was in 1984 in Oregonand the method of delivery was food. We have under-
invested in food safety. Less than 1 percent of all food imports are properly in-
spected. We have fewer than a thousand food inspectors expected to oversee 56,000
food sites. Given that two of the major biochemical agentsanthrax and tula-
remiaas well as a large number of disease-producing organisms may be trans-
mitted through the food supply, we absolutely must do more to ensure the safety
of our food.
Finally, for those likely bioterrorist agents for which we have no treatment and
for those infections for which we have inadequate vaccines, we must invest in re-
search. Specifically, we need anti-viral therapies for smallpox and newer, improved
and more powerful versions of an anthrax vaccine.
25
PREPAREDNESS
Even if we do all that we can to prevent a bioterrorism attack, our preparedness

will ultimately define the impact if such an attack were to occur. Therefore, our pro-
posal to bolster preparedness includes what we must do, and if implemented prop-
erly, will ensure that we are perched and ready to respond at every levelfederal,
state and local.
As GAO reported last week, we must strengthen and better coordinate our federal
bio- response program. As Secretary Thompson has stated, the federal government
has already done a lot. We have a rapid response team of over 7000 health care
providers for medical emergencies. We can deploy truckloads of therapeutics and
medical supplies in 12 Hour Push Packagesthe key component of the National
Pharmaceutical Stockpile. However, we must do more to strengthen our resources.
Currently, the stockpile has enough antibiotics to give complete prophylaxis to 2
million people after an anthrax exposure, but that number is not large enough. To
expand the contents and number of the push packages as well as increase our drug
and vaccine inventories, we are asking for a doubling of the amount currently being
spent to supply and support the national stockpile.
However, the federal preparedness is not sufficient unless our state and local
agencies are also prepared. Unfortunately, our local preparedness is severely lacking
today because it is inadequately underfunded. We have allowed our public health
systemthe front line of our defenseto deteriorate over the past 20 years. We
must buttress our local response by upgrading local and state medical surveillance
epidemiology; assuring adequate staffing and training of health professionals to di-
agnose and care for victims of bioterrorism; and improving our public health labora-
tories, many of which simply are not equipped to efficiently diagnose infections and
other diseases associated with biochemical weapons. Finally, we must ensure that
local entities are prepared to cope with the early situationfrom recognition
through diagnosis and initiation of treatment, until federal assistance in the form
of push packages and other assistance can arrive.
For all of these reasons, most of the funding in our proposal almost $1 billion
is directed to improve our state and local responsiveness, and this investment will
take a few years to fully implement.
RESPONSE
Once preparedness is maximized, the key to response and mitigation of disaster

rests principally with coordination and seamless crisis management. Therefore, our
proposal ensures that we have the plans and resources developed for an appropriate
response by ensuring adequate health care personnel and hospital preparedness. We
must improve our disaster response medical systems, including strengthening the
National Disaster Medical System, the Metropolitan Medical Response System, and
the Epidemic Intelligence Service.
Hospitals will be the natural destination for those who are victims of a bioter-
rorist attack and for those who seek relief from fear. However, only one in five hos-
pitals have developed a plan for such a calamity. They are ill-prepared for the re-
sulting surge capacity. We must ensure that local hospitals are equipped to provide
appropriate crisis management structuresby ensuring that every hospital not only
has a plan for dealing with a bioterrorist attack but also has appropriate surge ca-
pacity, decontamination units, and necessary supplies for the immediate needs.
With all of the proposed preparation, we will be able to respond by implementing
our detailed plans of action, deploying appropriately trained health care profes-
sionals and resources to care for thousands of individuals who will seek care, and
providing up-to-date information regarding risk reduction.
One of the marvelous things about this particular investment is its dual usenot
just preparing for a rapid response to in the event of germ warfare but also
strengthening a system that every single day contributes to the improved health of
all Americans. Now is the time to strengthen our public health system and ensure
that we can adequately prepare for and respond to potential bioterrorist attacks,
natural infectious disease outbreaks, or other challenges to the public health.
I commend the Administration for taking steps to address bioterrorism by not
only increasing funding before the attacks of September 11, but also assigning Gov-
ernor Ridge as the primary federal coordinator of such activities.
The Frist-Kennedy Public Health Threats and Emergencies Act provides the ap-
propriate framework for a comprehensive biodefense plan. Now is the time to fund
this authorizing legislation. In view of the increased risks of a bioterrorist attack,
we must act now to fill the gaps we have identifiedgaps that if allowed to persist
debilitate our responseand to move us from the under-prepared to the appro-
priately prepared state.
26
Senator HARKIN. Thank you very much, Senator Frist, and Sen-
ator Kennedy.
Just as a postscript, Senator Frist, I was back home this last
weekend, and a friend of mine who is a doctor in Des Moines came
up to me and said, how am I supposed to recognize it? He said, I
have never been trained to recognize anthrax. He said, we need
help out here to start to recognize it. That is one of the points you
just made there. We need to get that information out and training
out at the local level, so I appreciate your comments. This just hap-
pened to me this last weekend.
I am now going to move to Senator Hagel and Senator Edwards,
who just introduced new legislation, and I recognize the time con-
straints and how busy our Senators are, Senator Kennedy, Senator
Frist, and please stay if you would like, but if you would like to
leave, we would excuse you at this time.
Senator BYRD. Mr. Chairman, in the event that these two Sen-
ators need to leave, they mentioned a figure of $1.4 billion. How
did you arrive at the $1.4 billion? How do you break that down,
and how much of that needs to be appropriated immediately? Can
it be broken down into phases that would help us to better under-
stand it? I do not know how we can spend $1.4 billion better than
in this very exercise here.
Senator KENNEDY. Quickly, Senator, half of it is, as Senator Frist
pointed out, for our public health services. Those resources will be
invested in the States. That is the front line. That is on the basis
of figures estimated by the public health service, and the particular
organizations, the Public Health Laboratories, for example. This is
basically how we got it, and it was rather a lean budget on that.
You will find about another quarter or so of it is for the hospitals
in terms of developing outreach programs, and the remaining third
are listed here, and cover a number of the different kinds of pro-
grams that Senator Frist pointed out in terms of surveillance, the
development of various vaccines, and the storage and purchase of
those programs. This breakdown which is a part of our testimony
is an activity sheet where we give the figures, the allocations of the
$1.4 billion to each of probably 10 different initiatives, and we will
be glad to submit to the committee the additional kinds of support
for each of those.
There are some provisions that are not on there. Food protection
is not on here. The agricultural aspects are not on here. There is
not a program on here, although the Secretary will probably talk
about it, like the Nunn-Lugar programs, in order to try to do some-
thing over in the former Soviet Union in terms of the employment
of some of those scientists, so those elements are not on here and
probably may have to be added. but this is really the public health
aspect of the program, and we have submitted it, and we will be
glad to work with the staffs of the committee to give the particular
justification.
Senator FRIST. Mr. Chairman, could I just add to that very brief-
ly? The documents from this chart should be made a part of the
record, and should be before you. There are certain elements up
here, and you see that $635 million of the $1.4 billion is for State
and local preparedness capabilities. We absolutely must address
that particular issue. Some of the $635 million could be multiyear.
27
It needs to be made available now, but it could be multiyear in

terms of the way it is carried forth.
What we have done is looked at what is needed and backed it
forward, recognizing that we see this increased risk. If you go down
that list, the second area, improving hospital response capabilities,
the $295 million, it is important that it be addressed. We would
recommend that it be provided this year. To carry out that program
fully will take 2 to 3 years. Our staff will be working with the com-
mittee staff, because as you go down that list there are a few
things on there that could be multiyear. It does not have to all be
right now. If it is right now, we will obviously be able to go from
an unprepared to a prepared state.
Senator BYRD. Thank you.
Senator HARKIN. Mr. Chairman, since I have got your attention
on this, we mentioned food safety, and I would like to just give you
these figures. You might think about them, and you can write them
down.
Senator BYRD. My problem is, I cannot write. I cannot read my
own writing after I get it down.
Senator HARKIN. I have the same problem.
Senator BYRD. That is why I do not play the violin any more.
Senator HARKIN. That is a loss, because I have heard you play
the violin in the past. But I want to give you these figures about
food safety, and I have been harping on this for sometime. Last
year, USDA received $712 million to inspect 6,000 meat, poultry,
egg product and import establishments. So they got $712 million to
inspect 6,000 establishments. FDA received $260 million, one-third
as much, to inspect 57,000 food establishments and over 9,000 ani-
mal, drug and feed establishments, as well as a majority of food
imported into the United States.
Of the 7,000 food-borne illnesses that we detected, 85 percent
were linked to foods regulated by FDA. We have a gaping hole out
there in our food safety, especially in terms of the importation of
foods into this country. We just have a big, gaping hole there, and
we have got to fill that. I would hope that we would look at some
of that $1.4 billion in terms of that, and getting to the FDA and
giving them the resources they need to do these inspections.
Senator DURBIN. Mr. Chairman, if I could just comment on that
very briefly, one issue that I have been focused on is putting to-
gether one science-driven food safety inspection agency. We now
have 12 different Federal agencies involved in food safety inspec-
tion, and 35 different laws. Senator Frist and Senator Kennedy,
thanks for raising this issue.
Next week, on October 10, we are going to have a hearing in the
Government Affairs Committee that is going to focus on food safety
and security. Believe me, this is a big undertaking, to finally har-
monize this, and I look forward to working with you in trying to
make sure we do the right thing.
Senator HARKIN. You have a been a leader on that, and we ap-
preciate it, and we do need one central food agency. It is all spread
out now. We need one agency to look at food safety in this country,
and we need to combine those that are in USDA and FDA some
how.
28
Again, I thank the Senators, and please stay or leave as you so

desire.
Now I turn to Senator Edwards and Senator Hagel, who have in-
troduced the Biological and Chemical Weapons Preparedness Act of
2001, and going down the line of seniority I would recognize my
good friend and my neighbor from across the Missouri, Senator
Hagel of Nebraska.
STATEMENT OF HON. CHUCK HAGEL, U.S. SENATOR FROM NEBRASKA
Senator HAGEL. Mr. Chairman, thank you, and to you and to our
Ranking Member, Senator Specter, we are very appreciative that
you would put the focus on this, as has already been established
this morning, because of its most critical nature, and to Chairman
Byrd, thank you, because you will play a rather important role in
all of this, and to our colleagues Senators Kennedy and Frist, I,
too, would add my appreciation for their leadership and commit-
ment to, in fact, as much as anyone could have, stay ahead of this
issue.
I am reminded, Mr. Chairman, when Wayne Gretzky, the great
hockey player, was asked why was he so great, he responded by
saying, well, I am not sure I was that great, but if there was any-
thing I tried to do, it is that I tried to skate not where the puck
was, but where I thought the puck would be. Certainly Senators
Kennedy and Frist have skated to where they thought the puck
would be, and they were right.
In the interests of time, Mr. Chairman, I will submit a statement
for the record. My colleague, Senator Edwards, has taken a very
significant lead role on this issue through his committee assign-
ments and his own interest in something very important, as one of
the great challenges of our time, and I appreciate working with
him. This issue has been referred to this morning by those who
have spoken. It is a critical, integral part of our long-term war on
terrorism.
It is about, as we have heard, preparation, prevention, and de-
fense, but, as Senators Kennedy and Frist have laid out, all the
components of this now must come together. I hope that what Sen-
ator Edwards and I have done by introducing our legislation, which
he will speak to in a more framed way, I suspect, is to move for-
ward what is critically important to coordinate the local, State, and
Federal responses, meaning that this coordination is going to be
absolutely essential. It is going to require resources that it now
does not possess. It is going to require infrastructure which we do
not now have. It is going to require thinking that we have not ap-
plied before.
So what Senators Kennedy and Frist have done is laid down a
very important baseline. Senator Kennedy mentioned, as you did,
Mr. Chairman of the Agriculture Committee, the need to deal with
the agriculture piece here, and this is an area that Senator Ed-
wards and I felt that we could contribute to by adding onto what
Senators Kennedy and Frist have already done. We have done that,
and we will be prepared to answer any questions.
As to where we think some of this money should go, our overall
number is $1.6 billion. We have that broken down, and we would
be glad to share that with you whenever you would like.
29
I would summarize my thoughts on this by saying, Mr. Chair-

man, as both Senators Frist and Kennedy have noted, that it is im-
portant that we not panic the American public. It is important that
we speak plainly, directly, clearly, and honestly to the American
public, as the President is doing, and as Secretary Thompson is
doing. But we need to keep this in proportion, so that the American
people can be assured, and as we continue our efforts here they
will be assured, that we are dealing with this and they should have
a high degree of confidence in what we are doing.
As you all know, and many of you have been around here a lot
longer than I have and have provided leadership to this great coun-
try, we are now confronted with the great challenge of our time.
Not since World War II has our Nation been confronted with such
enormity in the completeness of this challenge. I believe our coun-
try is up to it. I believe our leadership is up to it. I think we have
seen some testament to that over the last 3 weeks in how our
House and Senate, and our Democrats and Republicans have
worked together on this. This certainly seems to be, regarding this
area that we are dealing with this morning, a very clear example
of how that is coming together.
There is one last point I would make, which I think says it all,
Mr. Chairman. You probably have seen the cover of Time Magazine
this week. Time Magazines cover, and a very, very good story
about this issue, does not say it all, but it says an awful lot. It
asks: How real is this threat? That is what we are talking about
this morning. We all agree the threat is very real.
Mr. Chairman, thank you.
Senator HARKIN. Thank you. I brought Newsweek, which asks:
How scared should we be?
It is almost the same cover.
Well, thank you for your leadership in this area, Senator Hagel.
Now I turn to Senator Edwards. Senator Edwards, I know you
have spoken to me a number of times about this issue and your
concern about it, and your focus on working with Senator Hagel to
develop this legislation. So we do appreciate that, and we thank
you for your leadership, and thank you for being here this morning.
STATEMENT OF HON. JOHN R. EDWARDS, U.S. SENATOR FROM NORTH
CAROLINA
Senator EDWARDS. Mr. Chairman, thank you very much, and
Senator Byrd, we thank you for your critical time on this issue. I
think what this hearing shows, Mr. Chairman, is that the Senate
is prepared to deal with not just the terrorist attacks of the past,
but also the potential terrorist attacks of the future. I want to
begin, as Senator Hagel did, by commending my colleagues Sen-
ators Kennedy and Frist, who have been leaders along with mem-
bers of this subcommittee on this issue for years.
We fully endorse their request for additional resources. I do be-
lieve, though, Mr. Chairman, in addition to additional resources,
we are also going to need to see some changes in our policies to
deal with the national security threat to our country.
Let me start, Mr. Chairman, if I could, by asking you and others
to picture in your minds eye what a biological attack would look
like. First, there would be no explosion. There would be no plane
30
crash. There would be no catastrophic event of any type. Instead,

it would be a silent attack. It may not be seen for days, or even
weeks, and it would first show up, as Senator Byrd described, as
a case that looked very much like a bad cold or the flu in a hospital
on one side of town. Then you would have another case with a child
on the other side of town, and then you would have a case out in
the county somewhere at a hospital, or seen by a primary care pro-
vider.
The critical question is, how much time passes before we recog-
nize that there is something more than a cold or the flu going on,
and the only people who can make that determination are your
local emergency room personnel, the local health care providers,
primary care physicians, and local nurses. Those are the people.
They are our first line of defense in any kind of biological attack,
and they are the key.
We could have all the teams in the world with extraordinary ex-
pertise gathered together in Washington, DC, but if these people
who are on the front lines of providing health care across the coun-
try are not ready, it is very difficult for us as a Nation to be ready.
Senator Frist talked about how few, if any, of these people have
ever seen a case of anthrax or smallpox. They do not know what
to look for, what the symptoms are, and they also do not know how
to react.
That is the reason, Mr. Chairman, we are not adequately pre-
pared, but all of us are here to say to the American people, we will
be, and we are committed to being completely prepared. It is not
flashy, it is not high tech, but it is the key to getting us ready to
respond to the potential for a serious biological attack on our coun-
try.
I want to also commend Secretary Thompson for the work he has
done. He knows from being Governor how critical these primary
care providers are, and how critical they are to our response.
Senator Hagel mentioned he and I have offered legislation in ad-
dition to complementing the work that has been done by Senators
Kennedy and Frist. There are two components of our legislation
that we hope builds on the work that they have done.
One component is that we have a significant amount of money,
$555 million, specifically in the form of block grants that go to
State and local agencies, so that we do not have the money staying
in Washington, DC, but we in fact get it to the front lines, to those
people that we have all talked about this morning that are so crit-
ical in any sort of response on a national level to a biological at-
tack, to get them trained, get them educated, get them prepared to
put a disease surveillance system in place so that they could com-
municate the information among themselves to the people who
need to know.
The second area that we have added is the issue of agriterrorism,
of which both Senators Kennedy and Frist have made mention. Ev-
eryone recognizes this is a serious issue. We have $100 million in
the form of block grants for agricultural terrorism, and $350 mil-
lion for food safety, and also in the area of Federal Government
programs for agricultural terrorism.
So we are working with our colleagues. All of us are committed
to do what is necessary. The work that Senators Kennedy and Frist
31
have done and have shown extraordinary leadership on, along with
the work of this subcommittee, has been critical. The work that
Senator Hagel and I have done I think builds on that, first, by get-
ting money directly to the people who we believe need it most, the
people who are going to have to recognize that a biological attack
has occurred and coordinate the response to that biological attack,
and second, by dealing with the specific issue of agriterrorism and
food safety, which all of us are concerned about and recognize is
a serious national threat.
So Mr. Chairman, what I would say, and I think all of us would
say to the American people, while we may not be fully prepared at
this moment to respond, we are committed to being completely and
totally prepared very quickly.
Thank you, Mr. Chairman.
Senator HARKIN. Senator Edwards, thank you for a great state-
ment. Thank you for your leadership on this issue in light of what
has been happening lately, and for working with Senator Hagel
and all of us to move this forward.
Senator BYRD. Mr. Chairman, may I ask a quick question? You
asked for $1.6 billion. Senator Frist and Senator Kennedy are talk-
ing about $1.4 billion. How does your $350 million, your $100 mil-
lion, and your $555 million square with similar items in their re-
quests?
Senator EDWARDS. Senator Byrd, I think we have worked with
Senators Kennedy and Frist in coming up with these numbers. I
think it is a matter of how we describe the figures. In fact, the ad-
ditional money that is in our bill, in addition to what Senators
Kennedy and Frist are proposing, is primarily aimed at agricul-
tural terrorism, which is not something that is specifically ad-
dressed in their request. I believe, though, that our numbers are
very much in line, because we have been working with them.
Senator BYRD. And your initial request, let us say it could be ap-
propriated this year, what would it be, the initial portion of the
$1.6 billion?
Senator EDWARDS. I think it is a 1-year appropriation request,
Senator.
Senator BYRD. The $1.6 billion?
Senator EDWARDS. Yes, sir.
Senator BYRD. Then is that the case, Dr. Frist, with yours?
Senator FRIST. Conceptually, about .4 of the $1.4 billion needs to
be for filling these gaps, and is ultimately going to need to be
factored into a baseline as we go forward. There are just huge gaps
in public health infrastructure and the like. Conceptually, about $1
billion of that is in response to the emergency money that needs
to come in now. I do not know if it would come out of the $20 bil-
lion that was mentioned. That depends on how you determine it.
Of that $1 billion, just big picture overall, about 50 percent of
that could be over a 2- to 3-year period.
Senator HAGEL. Senator Byrd, our percentages are not unlike
what Senator Frist has said, too. We all recognize that, as Senator
Frist said, the infrastructure is not in place now to be able to ab-
sorb that much resources coming within a 12-month period.
Senator BYRD. Thank you. Thank you very much.
32
Senator HARKIN. Thank you all very much. I thank Senators

Kennedy, Frist, Hagel, and Edwards for being here.
Now we will turn to Secretary Thompson, Secretary of Health
and Human Services, who we welcome. I want to welcome you, Sec-
retary Thompson, and commend you and your Department for its
rapid and professional response to September 11.
I understand, Mr. Secretary, you personally supervised HHSs re-
sponse to the attack, sending health officials to New York to pro-
vide expertise and assistance in deploying Push Packages of emer-
gency materials, including pharmaceuticals, that arrived in New
York in under 7 hours. You are to be commended for HHSs level
of preparedness, and your calm and speedy response to the crisis.
And with that, Secretary Thompson, your full statement will be
made a part of the record. I know that you are under some time
constraints. Welcome again to the subcommittee, and please pro-
ceed as you so desire.
STATEMENT OF HON. TOMMY G. THOMPSON, SECRETARY, DEPART-
MENT OF HEALTH AND HUMAN SERVICES
ACCOMPANIED BY DR. SCOTT LILLIBRIDGE

Secretary THOMPSON. Thank you very much, Mr. Chairman, Sen-
ator Specter, other distinguished members of the subcommittee. I
appreciate very much this opportunity to appear in front of you. I
also want to thank Senators Kennedy and Frist and Hagel and Ed-
wards for their tremendous support and their tremendous introduc-
tion of legislation that can be very helpful.
I would like to thank you, Mr. Chairman, for your attention to
a subject that has long been of very much interest to me, and has
become a concern of all Americans since the terrorist attacks.
The Department of Health and Human Services is responsible for
the public health responses to any biological or chemical attack, as
well as for disease surveillance and medical preparedness. In the
wake of September 11, there are questions about how prepared our
Nation is to respond to a biological attack, and rightfully so.
Let me characterize our status this way. We are prepared to re-
spond, but there is much more that can and should be done to
strengthen that response. We have needs in the short term and in
the long term. At HHS we are aggressively pursuing those needs
so that we can build the strongest, most coordinated response pos-
sible to a biological attack.
Let me outline for you this morning what steps have been taken,
what we are doing currently, and what our most pressing needs
really are. We made great strides in our preparedness in the past
8 months, because the President and his administration have made
it a priority, designating Vice President Cheney to lead a task force
on this and just recently nominating Governor Tom Ridge, an out-
standing Governor, to head up the national security.
For me, bioterrorism has been a concern for years. In fact, after
being nominated for this position last December, the first briefing
I received while still back in Wisconsin was on bioterrorism, when
we moved rapidly to make sure the Department was improving its
ability to respond. We began by making sure we were better coordi-
nated, not only within our Department and the administration, but
33
within the State and local partners who depend so much on a

strong and efficient response.
I moved bioterrorism into my immediate office, appointing Dr.
Scott Lillibridge, who is with me today, who is a doctor, and at
CDC as my Special Assistant for Bioterrorism. Dr. Scott Lillibridge
is one of the countrys most respected bioterrorism experts, and I
charged him with making sure that the Department was working
in a coordinated and aggressive manner to strengthen its capabili-
ties. We sent a strong message to our Department that this issue
is a priority, and that we will be ready.
We have also reached out to work more closely with the State
and local governments, but a lot more needs to be done in that
area. We have taken steps to improve our pharmaceutical stock-
piles, and made investments in research in our public health infra-
structure. In fact, this week we sent another $10 million out to 25
cities through the metropolitan medical response system to go from
97 cities to 122 cities that have the expertise to handle bioter-
rorism, and just this past week, we accelerated the production of
a new smallpox vaccine.
We brought together CDC, NIH, FDA, manufacturers, and some
outside consultants, and we have developed an accelerated plan
that would produce the new smallpox vaccine by mid to late next
year, and 40 million doses were to be delivered in the year 2005.
Now it will be delivered in the year 2002. This shows how aggres-
sively we are striving to strengthen our readiness and our re-
sponse, but my confidence in our ability to respond comes from how
our Department performed on September 11.
We had two major cities, as all of us know, that were simulta-
neously hit with terrorist attacks. When we began to respond that
morning, we did not know if there was bioterrorism involved, and
we did not know how many injuries or casualties there would be,
and yet we immediately implemented our health alert system at
the Centers for Disease Control. We contacted all the State health
departments and put tham on alert, saying that if you see some-
thing suspicious, please contact us. This immediately put State and
local health departments on alert for anything unusual or mys-
terious in terms of illness.
We also put 81 health laboratories across America on alert so
that they could analyze any blood samples or any tissue samples
that came in.
We then activated our national disaster medical system, which
comprises 90 DMAT teams, or 7,000 medical professionals across
America. We ended up that day sending five of these DMAT teams
in to the City of New York, teams of doctors and nurses, over 200
individuals, as well as EMTs, and four to the Pentagon within
hours on that first day. These medical teams were on the ground,
supplementing the local health care system.
In addition, we sent mortuary teams to New York, Virginia, and
Pennsylvania to assist with identification and with the fatalities.
Within the first 24 hours, we sent from CDC a group of 35 epi-
demiologists. Now that has been increased to 55, to also help sup-
plement local medical needs. These highly trained experts were in
New York hospitals looking for any signs of bioterrorism, or the po-
tential for any outbreak of disease as a result of the damage.
34
For the first time ever, we sent a Push Pack containing 50 tons
of medical supplies to New York City. We have eight of these packs
strategically located throughout the country, and they are supposed
to arrive at any location within 12 hours. We were able to deliver
that Push Pack to the City of New York within 7 hours.
This is the first time our emergency response system had been
tested at this extreme level, and they responded without a hitch.
Granted, we did not find any signs of bioterrorism, but we were
there quickly. We had experts looking for any problems, and we
were prepared to move rapidly to contain and treat any problem-
atic disease. That response encouraged me, I believe it should en-
courage this committee and the Congress, and it should encourage
the American public that we do have the ability to respond.
Now, I by no means contend that our system is perfect or with-
out weaknesses. We have gaps. We can, indeed, make our re-
sponses stronger, and it is imperative, ladies and gentlemen, that
we do so. We must continue to accelerate our preparedness efforts,
and that is going to require a strong partnership with this com-
mittee and with Congress.
Frankly, bioterrorism preparedness has not been the highest fis-
cal priority in the past, as it competed with other public needs. My
hope is that this will change as a result of greater awareness of our
needs. Here are the areas in which we need to move more aggres-
sively. You heard a lot about it today, and the first one, and by far
it surpasses anything else, is our local public health infrastructure.
Without question, this is our greatest need.
We must continue working with State and local public health
systems to make sure that they are strong and prepared. This is
going to include developing response and contingency plans, mak-
ing sure that they have the tools to respond in educating their
medical community. A strong and coordinated response between
Federal, State, and local Governments is absolutely essential and
fundamental to our ability to respond effectively and in an emer-
gency. We must continue to strengthen that partnership.
We also need to make sure that doctors and medical profes-
sionals are able to get the continuing education and training that
they will need to be astute in the area of identifying diseases from
a biological attack. To supplement this effort, we plan to hold a bio-
terrorism conference every year for emergency medical profes-
sionals, the Nations best experts and scientists will keep them up
to speed with the latest in preparing for, identifying, and treating
diseases from biological warfare.
We would also benefit from expanding the number of slotsI
know that is something Senator Specter has been very interested
in, and I applaud him for itand that is in the CDC Epidemic and
Intelligence Service, so we have moved highly trained experts in
the field of identifying diseases. In fact, I would recommend to this
committee that the Federal Government consider paying and plac-
ing more EIS graduates in State health departments. Currently,
there are 42 EIS experts in the States, but we must make sure
that every State has at least one of these EIS epidemiology special-
ists in their health departments, and we should add more to the
States that could use the extra resources.
35
This program, ladies and gentlemen, would put uniquely trained

individuals on the ground in each State who can be a valuable re-
source for public health departments in educating and training
their medical community, as well as helping to identify anything
suspicious or unusual.
Also in regard to public infrastructure I have created an advisory
committee of public health experts, and I have asked Dr. D. A.
Henderson, who is the doctor that led the eradication of smallpox,
to lead that, including State and local officials. They are going to
help us and assist us in devising the most effective and rapid ways
to strengthen our local preparedness, and I have asked the Nations
Governors, public health agencies, public health industriesI met
with the American Medical Association, the American Health Asso-
ciation last week and asked them to convene a summit with the
Department in order to discuss bioterrorism.
I have spent the past few weeks meeting with leaders in the
biotech, the medical device, the pharmaceutical insurance indus-
tries, as well as the major medical societies. They agreed that we
need to work more closely together in the public and private sectors
to make sure there are no weaknesses in our biodefense. We must
continue investing in our local health care systems so that we are
ready to respond in a very effective and coordinated manner in the
event of a catastrophe.
The second area, pharmaceuticals, we must continue to accel-
erate the production of vaccines and antibiotics, invest in the re-
search, bolster our stockpiles and more Push Packs. I would like
this committee and Congress to add two more Push Packs to our
arsenal, making more emergency medical supplies available
throughout the country. After our New York experience in deploy-
ing a Push Pack for the first time, we are doing a review of the
packages and their contents. The packages performed well, and yet
we expect to further strengthen the Push Packages by better orga-
nizing them in terms of contents.
For example, we are in the process of developing a Push Package
specifically for a chemical attack, and one specifically for a biologi-
cal attack. We want to continue planning for tomorrow by making
sure that the stockpile and the Push Packs are as up-to-date as
possible. The third areaand Senator Harkin, this has been one of
yours and Senator Durbins and my real passions, and that is food
safety.
We need more inspectors. We have 750 inspectors in FDA to en-
sure the safety of our food supply and to inspect 55,000 different
sites. The FDA can use more help in monitoring our food, for this
is one area in which we are lacking, and which we must be much
more vigilant. We are aggressively working with the food industry
as well to make sure that their awareness is appropriately height-
ened, and I thank you, Senator Harkin, for your leadership, and
they are taking the necessary steps to secure the production and
delivery of food.
Security, finally, we need continued help with improving security
of all of our facilities and the resources those facilities hold. Public
health is a national security issue. It must be treated as such, es-
pecially in these times. Therefore, we must not only make sure that
we could respond to a crisis, but that we are secure in defending
36
our stockpiles, our institutions, and our products, and throughout

the past 3 weeks I have spent a great deal of time meeting with
Members of Congress, the Senate and the House. We have dis-
cussed our preparedness, our response, and our needs. I appreciate
all of your attention to this issue.
While I am personally confident in our ability to respond because
of the strides we have made in the past few months and years, I
appreciate this committee reaching out to determine what we can
do better, and what resources we need to become stronger. This en-
deavor must be pursued in partnership not just in this city, but
within cities all across America. As a Nation, we must deal with
this sensitive issue in a rational manner. People, Americans should
not be scared, and believe that they need to be gas-masked, and
people should not be frightened in using medicine and food. There
is nothing that we know of that would warrant such actions.
People should be vigilant, should be aware and alert. A biological
attack is certainly possible, but as President Bush has said, we
must not be intimidated. We must get back to living our lives. Yes,
we need to do more on bioterrorism, but we are prepared to re-
spond. The mission now is to accelerate the efforts to strengthen
that response and make sure that our local public health systems
are able to respond as well.
PREPARED STATEMENT
We are doing today what this country once thought it could put
off until tomorrow, and I applaud you. As always, I am confident
that you, this Congress and all Americans, will rise to the chal-
lenge.
PREPARED STATEMENT OF TOMMY G. THOMPSON
Mr. Chairman and Members of the Subcommittee, thank you for inviting me here
today to discuss the Department of Health and Human Services (HHS) prepared-
ness to respond to acts of terrorism involving biological agents.
Among weapons of mass destruction, bioterrorism features several characteristics
that set it apart from other acts of terrorism involving, for example, explosives or
chemical agents. While explosions or chemical attacks cause immediate and visible
casualties, an intentional release of a biological weapon would unfold over the
course of days or weeks, culminating potentially in a major epidemic. Until suffi-
cient numbers of people arrive in emergency rooms, doctors offices and health clin-
ics with similar illnesses, there may be no sign that a bioterrorist attack has taken
place.
Three important points must be considered in bioterrorism preparations. First, bi-
ological agents are easy to conceal. A small amount may be sufficient to harm large
populations and cause epidemics over a broad geographic region. Second, the con-
tagious nature of some infectious diseases means that once persons are exposed and
infected they can continue to spread the disease to others. Third, in the most worri-
some scenario of a surreptitious attack, the first responders are likely to be health
professionals in emergency rooms, physician offices, outpatient clinics, public health
settings, and other health-care activities rather than the traditional first respond-
ers. The longer the terrorist-induced epidemic goes unrecognized and undiagnosed,
the longer the delay in initiating treatment and other control efforts to prevent fur-
ther infectious outbreaks.
The broad goals of a national response to bioterrorism, or any epidemic involving
a large population will be to detect the problem, control the epidemics spread and
treat the victims. HHSs approach to this challenge has been to strengthen public
health infrastructure to deal more effectively with epidemics and other emergencies,
and to hone our emergency health and medical response capacities at the federal,
state and local level. HHS has also worked to forge new partnerships with organiza-
tions related to national security.
37
What has HHS been doing to prepare for this kind of event? Our efforts are fo-
cused on improving the nations public health surveillance network to quickly detect
and identify the biological agent that has been released; strengthening the capac-
ities for medical response, especially at the local level; expanding the stockpile of
pharmaceuticals for use if needed; expanding research on disease agents that might
be released; developing new and more rapid methods for identifying biological
agents and improved treatments and vaccines; improving information and commu-
nications systems; and preventing bioterrorism by regulation of the shipment of haz-
ardous biological agents or toxins.
Several HHS agencies play a key role in our preparedness for terrorist events, in-
cluding the Office of Emergency Preparedness (OEP), the Centers for Disease Con-
trol and Prevention (CDC), the Food and Drug Administration (FDA), and the Na-
tional Institutes for Health (NIH).
In order to advance an orderly and comprehensive approach to the many issues
involved in such preparation, in July of this year I appointed a special assistant
within the Immediate Office of the Secretary to lead the Departments bioterrorism
initiative. I have directed this individual, Dr. Scott Lillibridge, to begin creating a
unified HHS preparedness and response system to deal with these important issues.
Under my direction, Dr. Lillibridge will provide executive leadership and organiza-
tional direction for HHS budget, policy, and program implementation on terrorism
preparedness issues. Let me assure you that this is a top priority for me and for
my entire Department.
We are striving at HHS to strengthen our readiness and response, and our ability
to respond has been greatly improved over the last several years. The system is not
perfect, however, and we must continue to accelerate our preparedness efforts.
IMPROVED SURVEILLANCE IS KEY TO DETECTION
If a terrorist used a biological or chemical weapon against the civilian population,

how quickly the outbreak is detected, analyzed, understood and addressed would be
the responsibility of state and local public health jurisdictions and the Centers for
Disease Control and Prevention.
The CDC has used funds provided by the past several congresses to begin the
process of improving the expertise, facilities and procedures of state and local health
departments and within CDC itself related to bioterrorism. CDC has established a
Bioterrorism Preparedness and Response Program within its National Center for In-
fectious Diseases to direct and coordinate their activities. CDC has a dedicated anti-
bioterrorism staff of more than 100 full-time professionals comprising expertise in
epidemiology, surveillance, and laboratory diagnostics.
Over the last three years, the agency has awarded more than $130 million in co-
operative agreements to 50 states, one territory and four major metropolitan health
departments to support,
(1) Preparedness planning and readiness assessment;
(2) Epidemiology and surveillance;
(3) Laboratory capacity for biological or chemical agents; and
(4) The Health Alert Network (a nationwide, integrated, electronic communica-
tions system).
The CDC has launched an effort to improve public health laboratories that likely
would be called upon to identify a biological or chemical attack. The Laboratory Re-
sponse Network (LRN), a partnership among the Association of Public Health Lab-
oratories (APHL), CDC, FBI, State Public Health Laboratories, DOD and the Na-
tions clinical laboratories, will help ensure that the highest level of containment
and expertise in the identification of rare and lethal biological agents is available
in an emergency event. The LRN also includes the Rapid Response and Advanced
Technology Laboratory at CDC, which has the sole responsibility of providing rapid
and accurate triage and subsequent analysis of biological agents suspected of being
terrorist weapons.
The CDC is also working to provide coordinated communications in the public
health system, between federal agencies and between public health officials and the
public itself. To this end, CDC has the Epidemic Information Exchange (EPI-X).
The EPI-X is a secure, Web-based communications network that will strengthen bio-
terrorism preparedness efforts by facilitating the sharing of preliminary information
about disease outbreaks and other health events among officials across jurisdictions
and provide experience in the use of a secure communications system.
CDC has invested $90 million in the Health Alert Network (HAN), a nationwide
system that will distribute health advisories, prevention guidelines, distance learn-
ing, national disease surveillance information, laboratory findings and other infor-
mation relevant to state and local readiness for handling disease outbreaks. HAN
38
provides high-speed Internet connections for local health officials; rapid communica-
tions with first responder agencies and others; transmission of surveillance, labora-
tory and other sensitive data; and on-line, Internet- and satellite-based distance
learning. With the addition of several recent awards, CDC has provided HAN fund-
ing and technical assistance to 50 state health agencies, Guam, the District of Co-
lumbia, three metropolitan health departments and three exemplar Centers for Pub-
lic Health Preparedness.
CDC also manages the National Pharmaceutical Stockpile (NPS), which provides
us with the ability to rapidly respond to a domestic biological or chemical terrorist
event with antibiotics, antidotes, vaccines and medical materiel to help save lives
and prevent further spread of disease resulting from the terrorist threat agent. The
NPS Program provides an initial, broad-based response within 12 hours of the fed-
eral authorization to deploy, followed by a prompt and more targeted response as
dictated by the specific nature of the biological or chemical agent that is used. The
first emergency deployment of the NPS occurred in response to the tragedy in New
York city.
Because food may be a likely medium for spreading infectious diseases, FDA as
well as CDC have enhanced their surveillance activities with respect to diseases
caused by foodborne pathogens. PulseNet, a national network of public health lab-
oratories created, administered and coordinated by CDC in collaboration with FDA
and USDA, enables the comparison of bacteria isolated from patients from wide-
spread locations, from foods and from food production facilities. This type of rapid
comparison allows public health officials to connect what may appear to be unre-
lated clusters of illnesses, thus facilitating the identification of the source of an out-
break caused by intentional or unintentional contamination of foods.
BIOTERRORISM PREPAREDNESS AND RESPONSE
HHS coordinates and provides health leadership to the National Disaster Medical
System (NDMS), which is a partnership that brings together HHS, DOD, FEMA,
and the Department of Veterans Affairs (VA). The NDMS provides medical re-
sponse, patient evacuation, and definitive medical care for mass casualty events.
This system addresses both disaster situations and military contingencies. More
than 7,000 private citizens across the country volunteer their time and expertise as
members of response teams to support this effort. This system also includes approxi-
mately 2,000 participating non-federal hospitals. VA and DODs expertise and re-
sources are critical to many key aspects of NDMS response, and I would note that
these Departments have distinguished themselves on many occasions.
In most localized disasters, including the scurrilous attacks on the World Trade
Centers in New York and the Pentagon here in Washington, HHS organizes its
medical field response through the Office of Emergency Preparedness using a team
structure. Teams can include Disaster Medical Assistance Teams, specialty medical
teams (such as burn and pediatric), and Disaster Mortuary Teams. In addition, Na-
tional Medical Response Teams are able to deploy to sites anywhere in the country
with a supply of specialized pharmaceuticals to treat up to 5,000 patients. Cur-
rently, HHS can draw on 27 such teams that can be federalized and deployed to
assist victims. Such teams have been sent to many areas in the aftermath of disas-
ters in support of FEMA-coordinated relief activities.
HHS, through OEP, has the capability to mobilize NDMS resources, the Public
Health Services Commissioned Corps Readiness Force, as well as enlist the support
of other federal agencies, such as DOD and VA, to help provide needed medical and
public health services to treat disaster victims. In the last few years, these assets
were deployed to New York, Florida, Texas, Louisiana, Alabama, Mississippi, the
Virgin Islands and Puerto Rico in the aftermath of hurricanes and tropical storms,
and to New York and Virginia in response to the events of September 11, 2001.
However, regional or national response to a health emergency involving bioter-
rorism will also require that additional capacities be in place at the state and local
level before the disaster strikes. HHS, primarily through CDC, is supporting state
and local governments to strengthen their surveillance, epidemiological investiga-
tion and laboratory detection capabilities, as well as continuing development of a
national stockpile of critical pharmaceuticals and vaccines to supplement local and
state resources.
The Office of Emergency Preparedness is working on a number of fronts to assist
local hospitals and medical practitioners to deal with the effects of bioterrorism and
other terrorist acts. Since fiscal year 1995, for example, OEP has been developing
local Metropolitan Medical Response Systems (MMRS). Through contractual rela-
tionships, the MMRS uses existing emergency response systemsemergency man-
agement, medical and mental health providers, public health departments, law en-
39
forcement, fire departments, EMS and the National Guardto provide an inte-
grated, unified response to a mass casualty event. As of September 30, 2001, OEP
will has contracted with 97 municipalities to develop MMRSs. The fiscal year 2002
budget includes funding for an additional 25 MMRSs (for a total of 122).
MMRS contracts require the development of local capability for mass immuniza-
tion/prophylaxis for the first 24 hours following an identified disease outbreak; dis-
tribution of materiel deployed to the local site from the National Pharmaceutical
Stockpile; local capability for mass patient care, including procedures to augment
existing care facilities; local medical staff trained to recognize disease symptoms so
that they can initiate treatment; and local capability to manage the remains of the
deceased.
TRAINING
HHS has used classroom training, distance learning, and hands-on training activi-
ties to prepare the health and medical community for contingencies such as bioter-
rorism and other terrorism events. For example, in fiscal year 1999, Congress appro-
priated funds for OEP to renovate and modernize the Noble Army Hospital at Ft.
McClellan, Alabama, so the hospital can be used to train doctors, nurses, para-
medics and emergency medical technicians to recognize and treat patients with
chemical exposures and other public health emergencies. Expansion of the bioter-
rorism component of Noble Training Center curriculum is a high priority for HHS.
HHS has been working closely with the Office of Justice Programs (OJP) National
Domestic Preparedness Consortium and we will continue our excellent relationship
with them. OJP and HHS have teamed together to develop a healthcare assessment
tool and have also delivered a combined MMRS/first responder training program.
CDC has participated with DOD, most notably to provide distance-based learning
for bioterrorism and disease awareness to the clinical community. CDC is now mov-
ing to expand such training with organizations, such as the Infectious Disease Soci-
ety of America (IDSA), and Schools of Public Health, such as the Johns Hopkins
Center for Civilian Biodefense. The recent FEMA-CDC initiative to expand the
scope of FEMAs Integrated Emergency Management Course (IEMC) will serve as
a vehicle to integrate the emergency management and health community response
efforts in a way that has not been possible in the past. It is clear that these commu-
nities can best respond together if they are able to train together toward realistic
scenarios that leverage the best of both organizations.
CONCLUSION
In conclusion, the Department of Health and Human Services is committed to en-

suring the health and medical care of our citizens. We have made substantial
progress to date in enhancing the nations capability to respond to a bioterrorist
event. And, Mr. Chairman, the Department is prepared to respond! But there is
more we can do- and must do- to strengthen the response. Priorities include
strengthening our local and state public health surveillance capacity, continuing to
enhance the National Pharmaceutical Stockpile, and helping our local hospitals and
medical professionals better prepare for responding to a bioterrorist attack. Our
mission is to accelerate these efforts.
Mr. Chairman, that concludes my prepared remarks. I would be pleased to answer
any questions you or members of the Subcommittee may have.
Senator HARKIN. Mr. Secretary, thank you for a very poignant
and well-stated statement. It was right to the point.
Two things I would observe before I ask just one question. First,
I just want to note for the record and recognize Mr. Scott
Lillibridge, who is with you as the Special Assistant for Bioter-
rorism. You mentioned public health being part of national secu-
rity. I think that is a concept that we now really have to think
about. Public health is a part of our national security, and so I ap-
plaud you for thinking about it in those terms.
Second, there is a lot of talk, of course, about increasing airport
security and federalizing employees and making them more profes-
sional. Again, I am glad that you noted in your comments another
part of our uniformed services that gets overlooked a lot in our
country, and that is the Public Health Service Commissioned
Corps. The Corps is one of our uniformed services, and again, I
40
think we need to do more to heighten their public appearances out

there so that people know who these Commissioned Corps officers
are, to elevate their status, and to bring more people into the Pub-
lic Health Service.
Secretary THOMPSON. Thank you for saying that, Senator. I con-
gratulate you.
Senator HARKIN. I would like to work with you on that.
Secretary THOMPSON. Scott Lillibridge is a captain.
Senator HARKIN. Well, thats good that he is in the uniformed
services, and we have got to do more to get information on this out
there to people, and we will work with you on that. The only ques-
tion I have, Mr. Secretary, and I know your time is precious, in the
next few weeks we are going to be working, as Senator Byrd said,
to allocate this $20 billion that we appropriated earlier. Again, we
want to work with you to get the resources you need for CDC, and
the rest of your Department. I understand that you have submitted
certain requests to OMB; you have submited a budget for this addi-
tional funding, and they are reviewing it.
Can you provide this subcommittee with your professional judge-
ment of what those needs are, such as how much is needed for
stockpiling activities, the training you mentioned, the local public
health departments, the EIS people? We need to have some of that
information. If you cannot provide it now, could you help get it to
us? In other words, just as we are asking Senators Kennedy and
Frist where they think we need to go, we need to ask you, also,
where do you think we need to put this?
Secretary THOMPSON. Thank you, Senator Harkin. I have to defer
until OMB makes a decision on my request, but my request is very
much in line with what Senators Kennedy and Frist have indi-
cated, and we have worked with Senators Kennedy and Frists
staff, and we are relatively close on the numbers, not completely,
but I am very impressed by their proposal and where they want to
spend the money.
The public health system at the local level is where we need to
invest our dollars, and that is the area that I think the Senators
have indicated, what you talked about, Senator Specter has talked
about, and I applaud you for that, and that is exactly what we
need.
Senator HARKIN. Thank you very much.
Secretary THOMPSON. I will get you more information by the end
of the week, as soon as OMB makes a decision.
Senator HARKIN. Senator Specter.
Senator SPECTER. Thank you, Mr. Chairman. Secretary Thomp-
son, the day before yesterday I was at Lincoln University in the
Philadelphia suburbs, and was asked about protection for the popu-
lace, and I was asked about gas masks, and I told them I had no
gas mask, and from what you have testified to I take it you have
no gas mask either.
Secretary THOMPSON. I do not, Senator.
Senator SPECTER. With respect to any special antibiotics to
counter any bioterrorism, I told them that Senators had no special
antibiotics. I take it you have none, either.
Secretary THOMPSON. I have none, but we have 400 tons of that
in our Push Packs for the American people at large.
41
Senator SPECTER. So that will be available to Secretary Thomp-

son and Arlen Specter, like any other citizens, with no special pref-
erential treatment for the Cabinet?
Secretary THOMPSON. No preferential for the Cabinet, I am sorry
to report, or the Congress.
Senator SPECTER. Well, that is what equal protection means, Mr.
Secretary.
Mr. Secretary, you have been quoted as saying that the Govern-
ment can, quote, handle any contingency right now. Your state-
ment in your oral testimony has been that the Government is pre-
pared to respond, but that there are gaps. Was that an accurate
quotation that the Government, quote, can handle any contingency
right now, and do you stand by that?
Secretary THOMPSON. We can handle, we think we can handle
any contingency dealing with bioterrorism at this point in time,
Senator, but we also understand that there needs to be improve-
ments, especially in the local public health system. I mentioned
that, and the quote that you mentioned, was on 60 Minutes. I
went on to articulate that we need to invest money in the local
health system for education, for infrastructure, and I also pointed
out that I would like to see some EIS agents that graduate from
CDCs educational program after 2 years placed in every State
health department.
Senator SPECTER. Mr. Secretary, stay with CSPAN. They do not
edit your comments.
I can understand your caution, and your measured words. How
would you respond to Dr. Steven Cantrill, who is going to testify
later, probably early this evening the way we are proceeding so
farhe is with the Emergency Medicine Department at Denver
Health Medical Centerwhen he said, quote, this problem would
only be partially alleviated by the dispatching of Federal resources
to a specific locale, and would be further of no help if terrorists opt
to involve dozens of metropolitan areas simultaneously?
When you see the coordination of four hijackings, and perhaps
others which failed, and you see the level of sophistication and
their resources, what are the realities if, as Dr. Cantrill says, doz-
ens of metropolitan areas are attacked simultaneously?
Secretary THOMPSON. How we have got it set up, Senator, is we
have the Health Alert Network, and we put that on notice. Every
one of the 50 State health departments immediately after bioter-
rorism attacks, or even after the terrorist attacks on September
11they were notified, and we monitor State health departments.
They are supposed to feed into CDC any mysterious outbreaks of
any illnesses whatsoever.
We have also got 81 laboratories on notice that will be able to
analyze any blood or any samples, and we would send CDC EIS
specialists like Scott Lillibridge into communities if there was any
type of an outbreak, if we found anything mysterious whatsoever,
and they would get on the ground in that community, in Denver,
in Milwaukee, in Pittsburgh, and be able to work with the State
and local health departments.
Senator SPECTER. You did not mention Philadelphia.
Secretary THOMPSON. And Philadelphia, I am sorry, and we
would then be able to develop a plan, and if necessary move our
42
Push Package in, move extra personnel in. We have 7,000 DMAT
teams ready to be activated and placed into any particular commu-
nity.
I agree with the doctor that at the local level there needs to be
more education, more opportunities for research, and more things
we think we could provide a good share of that through CDC, Sen-
ator.
Senator SPECTER. Are the lights on? They should be set for 5
minutes so we can control the time, but I am going to conclude
here. Just very briefly let me ask you about the comments of the
GAO report, Mr. Secretary, which focused on the lack of laboratory
capacity for a large outbreak, and the lack of hospital emergency
capacity. How do you respond to those accounts by the GAO?
Secretary THOMPSON. I think we do lack laboratory capability
and we do lack hospital space, and we discussed that. I discussed
that with the American Hospital Association, I believe last Friday.
I also discussed it with the Department of Defense last week. I
talked to Secretary Don Rumsfeld and I asked if, in fact, we needed
some mobile hospitals from the Department of Defense, could we
be able to use them, and he said absolutely. We also asked them
the same thing about vaccines, dealing with anthrax, and the De-
partment of Defense said, absolutely.
Senator SPECTER. My final question relates to the issue raised by
the GAO regarding the adequacy of coordination with the respon-
sibilities being lodged in many departments, HHS, the Department
of Justice, the Department of Energy, the Environmental Protec-
tion Agency, FEMA, and others.
Governor Ridges duties have not been defined with any preci-
sion, and in the speech that the President made, he talked about
a Cabinet-level position, a Secretary of Homeland Defense, and
now there is talk about an agency, and I think we are really in the
formative stage as to what is going to be done here.
I am preparing some legislation in collaboration with Senator
Lieberman, and it is our view, or it is my viewwe have not
worked it all out yetthat there ought to be Cabinet rank and
there ought to be a way to have some authority when you start
dealing with various Secretaries. Washington is famous for turf
battles, and absent
Secretary THOMPSON. I am understanding that, Senator.
Senator SPECTER. I understand that you understand that. I have
seen that. I have seen some of the understanding back and forth.
Now, I know you cannot speak for the President, but as a judg-
ment, if Governor Ridge is going to come in and do an effective job,
is he not going to need some line of authority beyond having access
to the President? To try to arbitrate every single dispute, we know
the reality is that simply cannot happen. You have been very expe-
rienced in Government. Do you think we need a Cabinet level posi-
tion? Do you think we need some specific statutory authorization
which will enable Governor Ridge to do an effective job?
Secretary THOMPSON. First off, I think Governor Ridge is going
to do an outstanding job. He is a wonderful individual, and I think
the President chose very wisely. I think the President is looking at
this. I have not been privy to those discussions as such, and so I
43
do not think I should be talking for the White House on this sub-
ject, Senator.
Senator SPECTER. Thank you very much, Secretary Thompson.
Senator Byrd, Senator Harkin had to absent himself for a few
minutes. We are going to proceed in order of arrival: Senator Byrd,
Senator DeWine, Senator Landrieu, Senator Durbin, Senator Mur-
ray, Senator Gregg, and Senator Kohl, and I think Senator Gregg
ought to be higher here. He came in earlier.
Senator GREGG. That is okay.
Senator SPECTER. Senator Byrd.
Senator BYRD. Thank you, Mr. Chairman.
Mr. Secretary, you indicated that 42 epidemiologists were in the
50 States. I believe you said 42.
Secretary THOMPSON. That is correct.
Senator BYRD. You said we needed one in each State.
Secretary THOMPSON. I said at least one in each State.
Senator BYRD. How many States do not have at least one?
Secretary THOMPSON. I would think there are 13 at the present
time.
Senator BYRD. Including West Virginia?
Secretary THOMPSON. I am not sure about that, but I can check
and get back to you. I understand West Virginia does not have one.
Senator BYRD. How much money do you need to have 13 addi-
tional epidemiologists?
Secretary THOMPSON. We have them, but we would have to give
money to the States, or put in a Federal position in the State
health departments. I do not exactly know. We think that we
should have at least one in each and every State, Senator. I can
get you the exact figures and send them to you without any prob-
lem whatsoever.
Senator BYRD. Yes, if you would, please. Also, you indicated that
your proposal is pretty much like the proposals that are being
talked about by Senators Kennedy, Frist, Hagel, and Edwards.
How much difference is there in your amounts?
Secretary THOMPSON. There is some differenceI think, Senators
Hagel and Edwards, about $1.6 billion, I think Senators Kennedy
and Frist about $1.4 billion. I think ours is a little bit under that,
and we have made a proposal to OMB. But together, there is very
much uniformity in strengthening the local public health systems
and protecting food safety and security.
Senator BYRD. How much do you need? If it could be appro-
priated in the remainder of this calendar year, how much do you
need immediately?
Secretary THOMPSON. We think we need somewhere around $800
million.
Senator BYRD. May I ask, if you already have not done it, that
you break that down and send it to this committee immediately?
Secretary THOMPSON. I have to wait till OMB makes a decision,
but I would be more than happy to give it to you.
Senator BYRD. If we could know what you are asking for.
Secretary THOMPSON. I certainly will, Senator. I will get it to you
by the end of the week.
Senator BYRD. Very well. Now, you mentioned local, State, and
Federal health officials, and you emphasized the problem that ex-
44
ists in preparing the local and State officials to adequately deal

with a bioterrorism attack.
What is being done to establish clear channels of communication
between local, Federal, State, and other officials to enable them to
consult with one another in the aftermath of a bioterrorist attack,
and what do you think needs to be done at the Federal level to best
equip our State and local health departments to effectively prepare
for and respond to a chemical or biological terrorist attack?
Secretary THOMPSON. The best thing we could do right now is to
connect every State health department and as many of the local
health departments as possible with our Health Alert Network. We
have a very sophisticated computerized system in Atlanta through
CDC. That is where the experts are in infectious diseases, and
what we need to do is expand that into the regional and to local
health departments. That would be the best way to disseminate in-
formation as well as education from CDC through the States down
to the local levels.
The second thing is, putting, as you have indicated, these EIS
specialists in every State health departmentat least one and
probably more. Third, we have got to put on more expanded edu-
cational courses, especially for emergency doctors and nurses that
go into the emergency clinics. Fourth, we have got to discuss how
we would get the extra hospital beds if we needed them in a surge
capacity kind of situation.
Those are the four things, and it is communication, it is edu-
cation, it is personnel, and it is space.
Senator BYRD. Now, as to Federal resources to help bring these
things together, do you have a figure, and if so, has that request
been made to OMB?
Secretary THOMPSON. Those requests have been made to OMB,
and those requests have also been made by Senators Kennedy and
Frist in their proposal.
Senator BYRD. Would you mind adding that to the information
you are going to provide me?
Secretary THOMPSON. Absolutely, Senator.
Senator BYRD. One final questionand is the light red?
Senator SPECTER. I think it is yellow for you, Mr. Chairman.
Senator BYRD. Mr. Secretary, reference has been made to some
of your public statements to the media. You have said, or are sup-
posed to have said, in a recent media interview that the U.S. Gov-
ernment is: prepared to take care of any contingency, any con-
sequence that develops from any kind of bioterrorism attack. That
is a pretty broad statement.
Secretary THOMPSON. It is.
Senator BYRD. Do you stand by that today?
Secretary THOMPSON. I do.
Senator BYRD. Well, Mr. Secretary, I want to tell you in the
nicest way I know how
Secretary THOMPSON. I said we could respond, and evidenced by
what we did on September 11, I am absolutely assured that we
could respond to any contingency and control it.
Senator BYRD. Well, will you still love me if I say to you, I do
not believe that?
Secretary THOMPSON. I still love you.
45
When you are the chairman of the Appropriations Committee, I

will love you even more, Senator.
Senator BYRD. That is a broad statement, and Washington is so
full of hyperbole and broad statements. We know, or we should
know, because we make them, too. They tell me that it is a bad
thing to do if we mislead, and I know you do not intend to do that.
Secretary THOMPSON. I do not want to mislead. I want to calm
the American people so that people understand that we are pre-
pared.
Senator BYRD. Well, I just do not believe that, and I say that to
you very kindly. I think we ought to be very careful. I try to be.
Next year is my 50th year in Congress, and I have heard a lot of
broad statements made, and some of them were not kept, but I
hope that we will both be very careful what we say in this matter.
There is nothing more important. I want to help you get the money
you need. I want to do what I can.
Secretary THOMPSON. Thank you very much, Senator.
Senator BYRD. Thank you.
Senator HARKIN. Secretary Thompson, I would support what
Senator Byrd just said. There is a lot of concern in the land, but
I think Americans are not going to be intimidated, or reassured
from what you testified to regarding the response on September 11.
Those categorical statements will not really help, but the specifica-
tion as to what is being done in addition I think will be helpful.
I think America will be reassured that Senator Byrd spent a couple
of hours at this hearing, because he deals with the final markup
in the appropriations process.
Secretary THOMPSON. All I can say, Senator, is that we meet on
a daily basis with, I think, the best doctors and researchers and
scientists in the countryon a daily basis on this subject, and Scott
Lillibridge, if you would respond, are we prepared?
Dr. LILLIBRIDGE. Let me say we are ready to respond, that we
have many, many things in progress for preparedness, and that
those things need to be accelerated. Many of those things have
been. There is a complex task before us, and I agree that the public
health infrastructure, the hospital community and the other compo-
nents need to move in lockstep.
Senator SPECTER. I would yield back to the new chairman and
call on Senator DeWine first.
Senator HARKIN. If I just might interject, Senator DeWine, if you
would defer just a second, Mr. Secretary, I do not know what your
time is. I had information that you had to leave. I hope that Sen-
ators would respect that, and please let us know if you have some-
thing urgent that you have to go to. If you do, we would respect
that. Maybe Dr. Lillibridge could stay and answer questions that
are not answered by the time you have to leave.
Secretary THOMPSON. Thank you.
OPENING STATEMENT OF SENATOR MIKE DE WINE
Senator DEWINE. Mr. Chairman, I will be very brief.

Mr. Secretary, thank you very much for joining us. I want you
to put your old hat back on as Governor and look at it from the
point of view of a Governor or local official. It seems to me that we
46
have an immense challenge, certainly not a challenge we cannot

meet, but it is an immense challenge.
My home State is probably not unusual. We have county health
departments, we have a State health department, we have local
fire departments, some entirely voluntary, some are mixed, some
totally paid, Nation-wide tens of thousands of them, and within a
State, so many different people that may be the first line of de-
fense, the first people who respond to the problem, or maybe the
first people who have to try to detect that we do have a problem.
From a Government point of view, from a Governors point of view,
what do you think are the biggest challenges, and how are we
meeting those?
The second question related to that is, what has been your con-
sultation with Governors and with mayors and with local officials?
Secretary THOMPSON. I think some States are better prepared
than others. As it is in any case, any issue you will find some
States excel in certain areas and are far superior to other States.
I think what Governors have got to do is, they have got to work
with the National Governors Association, with the Department of
Health and Human Services, and with FEMA, and they should be
setting up an annual meeting, a summit on bioterrorism prepared-
ness, and I think it should be in consultation with our Department.
In fact, I sent out a letter, Senator DeWine, asking the National
Governors Association to call such a summit as soon as possible,
in consultation with us. I think that is the best way.
I think also that our local health support network is not as
strong as it should be, and I have said that many times, and even
though I think we are prepared to respond at the Federal level, I
do not believe that all State local health departments are as ready
as they need to be, and some of them will not be able to recognize,
some of them will probably not have the education or the experi-
ence, and that needs to be strengthened. That is why these EIS
specialists that I am asking be put in every State health depart-
ment is so very important.
In regards to what I would suggest from Governors, I would sug-
gest that they come together and form an advisory committee
through the National Governors Association to put together more
information, more education opportunities for local health depart-
ments.
Senator DEWINE. Thank you, Mr. Secretary. Thank you, Mr.
Chairman.
Senator HARKIN. Thank you, Senator DeWine. Senator Durbin.
OPENING STATEMENT OF SENATOR RICHARD J. DURBIN
Senator DURBIN. Thank you, Mr. Chairman. I want to thank the

subcommittee for their gracious hospitality. I will be very brief, and
speak to one particular issue, and it is one that has been already
alluded to in terms of my interest and Senator Harkins interest.
We at this moment in history have a great challenge and a great
opportunity. For 40 years, we have been debating bringing together
under one agency food safety inspection in America. Everyone is
agreed in theory, and we have been unable to do it.
47
We have, as I mentioned earlier, a dozen agencies, and 35 dif-

ferent laws. We have no standards that we can point to that make
any sense from the aspect of food safety or security.
Now we have a convergence of events here. We have the election
of a President who campaigned on creating such an agency. We
have a national challenge to deal with the safety and security of
our food supply, and I think we have a better political environment
than at any time in recent memory to finally tackle this.
I would like to ask you, Mr. Secretary, two questions. First, will
you join with Senator Harkin and myself and people from the ad-
ministration to talk about the road map to move us from where we
are today to such an agency? How we might achieve that in a time-
ly fashion?
Secretary THOMPSON. Absolutely, without a doubt, I think we
need to discuss it. I am not sure that we need a separate Depart-
ment. I think put under the rubric of FDA we could handle it. But
I certainly would love to discuss it, because to me, food safety has
got to be uppermost in every one of our minds. We have got to do
a better job, and we have not invested the resources.
I have got lots of ideas and I would like to share them with you,
Senator Durbin. I know you are passionate about it. And Senator
Harkin, I would love to be able to have the opportunity to sit down
with the two of you or your staffs or whatever and discuss how we
might be able to proceed to get this job done.
Senator DURBIN. I am going to have a hearing next week, and
I hope if you cannot attend that someone from your Department
can attend.
Secretary THOMPSON. I will try and attend.
Senator DURBIN. Thank you very much.
The second point is fairly obvious. Once we have established to
our satisfaction the improvement and modernization of our food
safety inspection system, it is clear that there will be countries
around the world who export food into the United States who will
also want to be part of this conversation so that they can export
and we can import with peace of mind.
I am hoping that we can then take whatever our initial thinking
is on this and expand it into a much larger dialogue involving the
European Union and other friendly, civilized countries around the
world that want to help us establish standards of safety and secu-
rity so that we can say to the American people, our food supply is
not only the safest in the world today, it will continue to be, even
if we bring in food from overseas. So I hope that we can find a way
to bridge our conversation into a much larger context.
Secretary THOMPSON. I would like to make sure that we invite
Secretary Veneman, because I know she is also, as Secretary of Ag-
riculture, extremely interested in this subject, and is very knowl-
edgeable.
Senator DURBIN. Thank you. Thank you, Mr. Chairman.
Senator HARKIN. Thank you, Senator Durbin. Senator Gregg.
OPENING STATEMENT OF SENATOR JUDD GREGG
Senator GREGG. Thank you, Mr. Chairman. Mr. Secretary, it is

a pleasure to discuss this issue with you.
48
The chairman, in opening this hearing, in fact went into some

length about the exercise Top Off, which was an exercise which
was energized as a result of the Commerce, State, Justice Sub-
committee of the Appropriations Committee and which we dis-
cussed, in fact in this room about 4 months ago when all the major
Departments involved in terrorism testified, and one of the conclu-
sions which I think came out of that hearing was that we did not
have adequate coordination amongst our Departments especially in
a variety of areas, but especially in the area of health care, and the
doctors who were on the ground in Denver who came and testified
felt very strongly that that was the case. I was wondering to what
extent your agency has reviewed the Top Off findings in Denver,
and what conclusions you have come to as a result of that.
Secretary THOMPSON. We have reviewed Top Off, we have re-
viewed Dark Winter, and we have taken all of the suggestions and
conclusions in developing them, and we looked at the problem. We
have tried to come up with a solutionhow we would fix itand
that is what Dr. Lillibridge has been doing for the last 5 months.
He has been evaluating them, and I think we have been making
a lot of progress in that area. But coordination is still a problem.
Senator GREGG. It is a huge problem. I congratulate the Presi-
dent for bringing in Governor Ridge. I think that is going to be a
very significant effort in coordinating, but one of the issues that
was raised there was the availability of vaccine.
Today, as I understand it, there is no vaccine being manufac-
tured for anthrax, none for pneumonic plague, none for botulism,
and the smallpox vaccine is being manufactured both for DOD and
for HHS, but the HHS timetable is next year, which I congratulate
you on accelerating that, but basically, it means we really do not
have any current existing new product in any of these areas, is
that correct?
Secretary THOMPSON. That is correct. I would like to point out,
though, that NIH is doing a wonderful job of research in coming
up with some new vaccines. They are not there yet, but there is
a lot more money that has been put into Dr. Tony Fauccis exper-
tise in trying to come up with this.
Senator GREGG. What should we do at FDA, then, I guess is my
question, to assist us in accelerating this process?
Secretary THOMPSON. What we do about every morning, Dr. Scott
Lillibridge meets with Kathy Zuhn from FDA and several other
specialists, and we are looking at ways in which we could expedite
and move this along, and I would rather have Dr. Scott Lillibridge
answer that question.
Dr. LILLIBRIDGE. Let me just mention this in brief discussion of
the activities. It takes a lot of elbow grease with the manufacturer,
FDA, scientific experts, and our best team from NIH, CDC, and
FDA to get together and push this issue forward. We have in the
space of about 2 weeks begun to accelerate smallpox vaccine pro-
duction activity. We have a timeline, we have a process, and again,
as the Secretary mentioned, we had a timeline of 2005, and we are
moving it down.
I think you also allude to the systemic problem of getting at vac-
cines. A couple of things on the horizonwe are working with the
Secretary of Defense on finalizing plans and collaborations on a
49
Government-owned contractor-operated facility for vaccines. We are

reaching out to the manufacturers in ways that we have not before.
We have also invited foreign manufacturers to come to the United
States to present their data about safety and efficacy, to get it ex-
pedited and reviewed so we can use it to protect the population.
As for anthrax vaccine, the production facility is being worked
with almost on a weekly basis, daily basis with the Food & Drug
Administration to help that facility get into full production shortly.
And they anticipate in perhaps as soon as 6 weeks they will be able
to resume production towards a licensed product.
Senator GREGG. Is this Dynpor?
Dr. LILLIBRIDGE. I would hesitate to mention the manufacturer,
but suffice it to say, the manufacturer for anthrax vaccine in this
country.
Senator GREGG. Now, if we would put the Defense Department
in charge of manufacturing vaccines, which is essentially one of the
proposals, is that really the best approach? One of the problems we
had that I think it was that we stopped producing pneumonic
plague vaccine because we could not get the Defense Department
to be the big player.
Dr. LILLIBRIDGE. Sir, that is exactly right. As we looked at this,
it looks like it is going to require multiple solutions, some with the
Government, some with private industry, some within regulatory
issues that we have to work through, and incentives across the in-
dustry, both public and private partnership working together and
looking at some of the off-shore options as well to get complete cov-
erage on all these issues.
Senator GREGG. My time is about up, but should this be decided
by you folks or by the Defense Department or by the Homeland
Secretary, the decision as to where these manufacturing capability
occurs, and what the time line is, and who is going to drive the
process of getting it done?
Secretary THOMPSON. I think it should be done in consultation
with all three, plus this subcommittee and your subcommittee.
Senator GREGG. Where does the buck have to stop?
Secretary THOMPSON. I think the buck has to stop on the medical
and health conditions. I think that has got to be the determining
factor.
Senator GREGG. Okay.
Secretary THOMPSON. Suffice it to say, it should be a medical de-
cision as much as possible.
Senator HARKIN. Senator Kohl.
OPENING STATEMENT OF SENATOR HERB KOHL
Senator KOHL. Governor Thompson, good to see you.

Mr. Secretary, I appreciate the tremendous efforts you made at
your Department to respond to a biological attack, and I know it
is a comfort to many Americans to know that our Government,
through your efforts, is prepared, but the question I most often get
asked by my constituents back in Wisconsin is, what should I do,
not so much what are you doing, but what should I do?
People want to know what they can do today to protect their
families from a biological attack. They ask questions like, should
they ask the doctors for vaccines, should they secure a room in
50
their house, should they make efforts to avoid public places, or cer-
tain areas of the country, are there questions they should ask their
doctor to determine whether or not the doctor is capable of recog-
nizing the symptoms of a biological attack?
Is the Department issuing recommendations or advice, Mr. Sec-
retary? In other words, what can you tell, or what would you say
to Americans all across our country today with respect to what
they can or should be doing to respond to this threat?
Secretary THOMPSON. I would strongly tell Mr. and Mrs.
Siddleson of Milwaukee, as I would Philadelphia, as I would San
Francisco, be very vigilant. Be very vigilant about your activities,
and anything suspicious, any kind of cold, or anything mysterious
dealing with your body. Illness or infections or rashes or coughing,
get to a doctor and ask that doctor if he or she knows anything
about smallpox, anthrax, botulism and so on.
I would not suggest buy a gas mask. I would not suggest that
they go out and buy a lot of cyprofloxin, or doxycycline, or peni-
cillin. I would strongly just urge them to be more alert than they
have in the past. If there is anything that their body is telling
them, they should check with their doctor as soon as possible, and
they should ask their doctor if their doctor knows things about bio-
terrorism.
Senator KOHL. All right, Governor. As you know, some of the
most advanced biological research in the world is occurring every
day at federally funded labs and our public universities, including
the University of Wisconsin, as you well know. We also know that
very important and vital research involves the use of dangerous bi-
ological agents. Of course, we must secure these labs and not allow
these lethal pathogens to fall into the wrong hands.
The CDC regulation that will go into effect next January will re-
quire upgraded security measures at these labs. I read in the paper
that you said that you would like to expend funds in order to in-
crease security at Government labs. My question to you is, what
are we going to do at university labs?
Secretary THOMPSON. I think we should find ways to increase the
security in all of our laboratories. I think it is very important, Sen-
ator Kohl. I am very happy you brought that up, and if I might I
would just like to ask Scott LillibridgeI forgot to do thisabout
getting vaccinated, because I think this is a question that a lot of
peopleand I think that we have looked at it, and we would
strongly suggest that that is not the best way to go. Scott.
Dr. LILLIBRIDGE. Thank you, sir. I have two things I wanted to
mention. Although the public health infrastructure is weak and we
are investing in the infrastructure to improve surveillance, the lab-
oratory science, and health alerting, our medical community and
our public health officers have never been better in history. They
have had more information, better education, local people must still
trust and seek advice locally. I do not want to dissuade anybody
from doing that.
The first issue, of course, in lockstep with, do we need gas masks,
is, do we need vaccinations at this time, and the answer is no. We
are not taking them in our senior management, nor are we recom-
mending them to the population, and the primary reason is that
most of the things we deal with have an incubation period. And
51
second, in the absence of disease, we would be confronted with

large numbers of side effects.
Senator KOHL. But dont you, or dont we vaccinate our soldiers
before they get involved in situations in which they may be threat-
ened?
Dr. LILLIBRIDGE. Well, I will not speak to the DOD vaccination
policy on soldiers in combat or staged in potential combat areas,
but we think the risks for civilians are different.
Senator KOHL. Is it because we do not have enough to vaccinate
all Americans today?
Dr. LILLIBRIDGE. No, sir. The primary issue is health and safety,
and our confidence that we would use those at the time of crisis
to be able to control the epidemic.
Senator KOHL. That is fine, and I will not spend too much time
contending that with you, but it does seem not to answer the ques-
tion of why would we vaccinate our military personnel as they are
entering combat, but not suggest that the civilian population needs
the same kind of protection. I do not think you have really re-
sponded to that in a way that I understand.
Dr. LILLIBRIDGE. Well, let me just add, then, that the policies of
the Department of Defense on vaccination have to do with practical
situations, expected exposures, and the way they deploy their
troops in high-risk areas. Looking at what we know and the way
we respond now, we do vaccinate for illnesses that are present in
the population. A case in point, childhood immunizations. However,
we do not vaccinate nor recommend in a public health standard at
this time to vaccinate the public for illnesses that are not moving
through the population if we have the capacity to respond accord-
ingly.
The other thing, in specific anthrax in the military, the Depart-
ment has taken the position that our responseprimary response
modalityis not vaccine. It is antibiotics for 30 or 60 days, for a
length of time to treat and prevent the illness, and that makes it
a little different for us on that issue.
As for smallpox, again there is an incubation period, and we can
target the vaccine most effectively. If you look back at the smallpox
eradication campaigns, it was not area vaccination that controlled
the outbreak, it was targeted surveillance and containment that
helped us control the outbreak, and we would do likewise if that
would recur in this country.
Senator KOHL. I just would like to get an answer from you, Gov-
ernor, on whether or not there will be some Federal funds available
to help university labs meet new security requirements.
Secretary THOMPSON. I cannot answer that, Senator Kohl. I wish
I could, but I cannot. A lot depends upon the request we put into
OMB. A lot depends upon Senators Kennedy and Frists proposal.
I do not think they put that kind of money in for securing labs on
our universities, but I think it is something that States should cer-
tainly consider strongly.
Senator KOHL. Thank you. Thank you, Mr. Chairman.
Senator HARKIN. Thank you very much, Mr. Secretary, for being
so generous with your time and your expertise, and thank you for
your leadership on this issue. Again, following up on Senator Dur-
bins comments, we look forward to working with you.
52
Secretary THOMPSON. I appreciate that. Thank you very much.

Senator HARKIN. We will now turn to panel 3. I would like to call
to the witness table Jonathan Tucker, Stephen Cantrill, Jerome
Hauer, Patricia Quinlisk, and Rex Archer. I thank this panel for
being so patient and for being here this morning. Some of you are
coming a great distance.
I will again state that all of your statements will be made a part
of the record in their entirety. We would be appreciative if you
could summarize them succinctly and hit the high points for us. We
would appreciate that so we might get into a generalized discussion
with you, the experts in this area, and we will just go down the
line in which I called the names, or in which I have them listed
here.
First I would recognize Dr. Jonathan Tucker, who directs the
Chemical and Biological Weapons Nonproliferation Program at the
Monterey Institute of International Studies, and is the editor of
Toxic Terror: Assessing Terrorist Use of Chemical and Biological
Weapons. He is also the author of Scourge: The Once and Future
Threat of Smallpox.
Dr. Tucker, welcome to the committee.
STATEMENT OF JONATHAN TUCKER, Ph.D., DIRECTOR, CHEMICAL &
BIOLOGICAL WEAPONS NONPROLIFERATION PROGRAM, MON-
TEREY INSTITUTE OF INTERNATIONAL STUDIES
Dr. TUCKER. Thank you, Mr. Chairman. Mr. Chairman, distin-
guished members of the subcommittee and guests, many thanks for
the opportunity to testify before you today on a concern that has
gripped the Nation in the wake of the September 11 terrorist at-
tacks on the World Trade Center and the Pentagon, which is the
possibility that terrorists might escalate their horrific campaign of
death and destruction by resorting to the use of unconventional
weapons, including biological pathogens.
Although experts disagree on the ease with which terrorists
could acquire and use biological agents, many studies have con-
cluded that the threat of bioterrorism against the United States is
growing, and that the Nation is not adequately prepared to handle
even a medium-sized biological attack. With a potential health
emergency in the making, time is of the essence in reducing our
vulnerability to this threat, and I believe there is much we can do
in the near term.
It is important to note that bioterrorism and the growing chal-
lenge of national emerging infectious diseases are two sides of the
same coin. Both phenomenon would manifest themselves in an un-
usual outbreak of infectious disease, one that would have to be rap-
idly detected, identified, and contained to minimize the harmful
consequences. Because some of the most deadly biological warfare
agents such as anthrax and plague respond to antibiotics adminis-
tered during the early phase of the infection, prompt diagnosis and
treatment could save many lives.
In the case of a contagious agent, rapid containment by isolation
and vaccination could prevent further spread. Both the emerging
infection and bioterrorist threats can be addressed most effectively
by strengthening the Nations public health systems, which unfor-
tunately have been allowed to atrophy over the past several dec-
ades.
53
In the event of a major outbreak of disease, whether the result

of a natural emerging infection or a deliberate terrorist attack, city,
county, and State health departments would be the Nations first
line of defense, backed up by the medical detectives and virus cen-
ters at the CDC, the National Institutes of Health, and other Fed-
eral agencies.
The first indication of an unusual disease outbreak, as others
have testified today, would be when the initial victims became ill
and sought treatment at emergency rooms and doctors offices. For
example, a group of people in an urban neighborhood or an office
building who were infected by a covert bioterrorist attack might
come down days later with nonspecific, flu-like symptoms.
Today, I believe it is essential to bridge three critical gaps that
would seriously impede the Nations ability to detect and respond
rapidly to an unusual outbreak of disease. The first gap in the U.S.
infectious disease surveillance system is between primary care pro-
viders and public health departments. Today, disease surveillance
systems in the United States are patchy in their coverage and lack
adequate resources.
In the case of the West Nile virus in New York City, the surveil-
lance system worked. Reporting by an alert physician was key to
the early detection of the outbreak. Nevertheless, a bioterrorist at-
tack or serious natural outbreak of disease would permit little mar-
gin for error. If health care providers are to be effective sentinels
of an epidemic, they must have the necessary training and profes-
sional awareness to include the possibility of emerging infections
and bioterrorism in the differential diagnosis. In addition, they
must have direct communication channels to the public health de-
partment, and be able to report cases at any time, day or night.
The second gap in the Nations infectious disease surveillance
system is between the human health and animal health commu-
nities. Many emerging infectious diseases and putative bioterrorist
agents are zoonotic, which means that they originate in animals
but can also affect humans.
Given the considerable overlap of animal and human pathogens,
animals can serve as useful sentinels for outbreaks of zoonotic dis-
eases. The West Nile investigation, however, exposed a major gap
between the veterinary and public health communities. Although
the key to identifying the causative agent lay in merging informa-
tion from the parallel investigations of the bird and human out-
breaks, communication between animal health and public health
agencies was poor, and what limited cooperation occurred was the
result of informal personal relationships, rather than official coordi-
nating mechanisms.
Finally, the third gap in the Nations infectious disease surveil-
lance system is between public health specialists and intelligence
analysts. The dual threats of emerging infections and bioterrorism
pose major conceptual and technical challenges for the U.S. intel-
ligence community, such as distinguishing between an actual out-
break of an emerging disease and the deliberate release of a patho-
gen by terrorists.
Although the CIA has recruited a few microbiologists and other
scientists for its analytical staff, this solution is not optimal, be-
cause scientists need to interact freely with colleagues from other
54
countries if they are to remain current and well-informed. A better

approach would be to provide for routine exchanges of people and
training between the U.S. public health and intelligence agencies.
To date, however, sharp differences in organizational culture such
as the need for secrecy versus scientific openness have impeded
interagency collaboration in analyzing bioterrorist threats.
I would like to make a number of recommendations now on how
these three gaps can be filled. To bridge the first gap between pri-
mary health care providers and public health practitioners, I would
recommend the following steps. First, the Department of Health
and Human Services should expand the national program of aware-
ness training by professional medical societies for primary health
care providers, including health care practitioners, emergency room
physicians, and nurse practitioners.
Second, the Department should provide grants to State and local
public health agencies to establish simple reporting mechanisms
and clear communication channels between medical practitioners
and city, State, or county public health departments, including 24-
hour telephone or e-mail hotlines to respond effectively when doc-
tors call, day or night. State and local health departments will need
additional funds to hire more staff members with expertise in infec-
tious disease epidemiology and information technology.
To briefly summarize my other recommendations on the need to
bridge the second gap between human and animal health commu-
nities, I recommend that the Department of Health and Human
Services and Department of Agriculture establish a surveillance
network that covers livestock, zoo animals, and wildlife so that un-
usual patterns of zoonotic disease will be reported promptly to
State and local health departments.
And to bridge the third gap between public health specialists and
intelligence analysts, I recommend the Department of Health and
Human Services establish formal exchanges of people and training
between public health agencies such as CDC and Federal intel-
ligence services.
In conclusion, Mr. Chairman, the natural emergence of a deadly
and contagious infectious disease such as the Spanish flu of 1918,
or the deliberate release of anthrax or some other pathogen as an
act of bioterrorism could result in serious loss of life and social dis-
ruption. Unless corrected, the three gaps that currently exist
among the U.S. medical, public health, animal health, and intel-
ligence communities could seriously delay detection of the resulting
disease outbreak and impede the prompt response needed to mini-
mize its medical impact and social consequences. Bridging these
three gaps will be essential if the Nation is to be better prepared
to deal with the dual threats posed by emerging infections and bio-
terrorism.
PREPARED STATEMENT
The good news is that, despite the anxieties we all share today
over this issue, the U.S. Government can take practical steps to re-
duce the threat. Improved disease surveillance, combined with
other preparedness measures, may make it possible in the not-too-
distant future to render biological weapons in the hands of terror-
55
ists, to borrow a phrase from President Ronald Reagan, impotent

and obsolete.
Thank you.
PREPARED STATEMENT OF JONATHAN B. TUCKER
Mr. Chairman, distinguished Members of the Subcommittee, and guests: Many
thanks for the opportunity to testify before you today on a concern that has gripped
the nation in the wake of the September 11 terrorist attacks on the World Trade
Center and the Pentagon: the possibility that terrorists might escalate their horrific
campaign of death and destruction by resorting to the use of unconventional weap-
ons, including biological pathogens. Although experts disagree over the ease with
which terrorists could acquire and use biological weapons, many studies have con-
cluded that the threat of bioterrorism against the United States is growing, and that
the nation is not adequately prepared to handle even a medium-sized biological at-
tack. With a potential health emergency in the making, time is of the essence in
reducing our vulnerability to this threat, and I believe there is much we can do in
the near-term.
It is important to note that bioterrorism and the growing challenge of natural
emerging infectious diseases are two sides of the same coin. Both phenomena would
manifest themselves in the form of an unusual outbreak of infectious disease-one
that would have to be rapidly detected, identified, and contained to minimize the
harmful consequences. Because some of the most deadly biological warfare agents,
such as anthrax and plague, respond to antibiotics administered during the early
phase of infection, prompt detection and treatment of an outbreak could save many
lives. With a contagious agent, rapid containment by isolation and vaccination could
prevent further spread.
The threats of emerging infections and bioterrorism can both be addressed most
effectively by strengthening the nations public health systems, which have been al-
lowed to atrophy over the past several decades.1 Back in the 1950s and 1960s, pub-
licly supported community hospitals and public health laboratories supported an ef-
fective early-warning network for detecting and containing epidemics. Since then,
however, the shift to privatized medicine and managed care has largely eliminated
this system. Shortages of manpower and infrastructure in the nations public health
departments have also impeded effective epidemiological surveillance, leaving the
public more vulnerable to serious outbreaks of infectious disease.2
My testimony will briefly address the dual threats of bioterrorism and emerging
infectious diseases, point out some key gaps and weaknesses in our current public
health defenses, and conclude with a number of practical policy recommendations
for improving U.S. response capabilities.
THE THREAT OF BIOTERRORISM
Although it is unlikely that a small terrorist group working on its own would have
the technical and financial resources to carry out a major bioterrorist attack on the
scale of the September 11 event, a state-sponsor might provide the terrorists with
the necessary know-how, seed cultures, and specialized dissemination equipment.
Alternatively, a wealthy terrorist organization might be able to recruit scientists
and engineers formerly employed by a state-level biowarfare program, such as that
of Iraq, South Africa, or the former Soviet Union. As the biotechnology industry con-
tinues to spread rapidly around the world, fermentation tanks and other equipment
used to produce biological warfare agents-much of which has commercial as well as
military applications-will become increasingly accessible to terrorists. Moreover,
given the current high level of public anxiety over bioterrorism, even a relatively
small-scale attack with anthrax or some other biological agent could have a dis-
proportionate psychological impact, eliciting widespread panic and undermining
trust in government.
Defense analysts also worry about the possible use of biological agents by hostile
states as a means of asymmetric warfare-David-and-Goliath strategies in which
small countries would seek to circumvent or blunt the conventional military suprem-
acy of the United States and its ability to intervene in regional conflicts. Such strat-
egies might involve the use of disease agents to attack troops or civilians, destroy
1 This testimony draws extensively on the following publication: Jonathan B. Tucker and Rob-
ert P. Kadlec, Infectious Disease and National Security, Strategic Review, vol. XXIX, no.
2 (Spring 2001), pp. 1220. 2 Rick Weiss and Ellen Nakashima, Biological Attack Concerns
Spur Warnings, Washington Post, September 22, 2001, p. A04.
56
U.S. crops or livestock, or contaminate the nations food supply. Biological attacks
could be carried out on a scale large enough to hamper or deter U.S. intervention
abroad, yet without crossing the mass-casualty threshold that could credibly trigger
nuclear retaliation. Even in the face of U.S. deterrent threats, a rogue state or ter-
rorist group that believed it could carry out an attack without attribution might be
tempted to do so, particularly in the heat of crisis or war.
A bioterrorist attack would probably involve the covert release of a microbial
pathogen that would give rise to detectable illness only after an asymptomatic
delay, or incubation period, when the microorganism is multiplying in the host to
cause disease. For example, Bacillus anthracis, the bacterium that causes anthrax,
has an incubation period of roughly six days. Individuals who had been exposed to
an invisible aerosol cloud of anthrax spores would probably be unaware at the time
that they had been infected. The first evidence of the attack would emerge days
later, when the infected individuals, by now widely dispersed, began to develop non-
specific, flu-like symptoms such as fever, fatigue, cough, and chest discomfort. A few
days later, severe symptoms would set in, including pneumonia, sweating, anoxia
(causing the victim to turn blue), and death, if the disease remained untreated. An-
thrax is not-I repeat, not-transmissible from person to person, but because the dis-
ease is generally fatal within 24 to 36 hours after the onset of severe symptoms,
antibiotic therapy (possibly combined with post-exposure vaccination to enhance the
patients immune response) must begin as soon as possible to have any chance of
success. It is therefore essential to identify an outbreak linked to a bioterrorist at-
tack early, while the disease is still treatable.
An even more challenging scenario would involve the deliberate release of a con-
tagious agent, such as plague bacteria or smallpox virus. Plague has an incubation
period of one to six days, whereas smallpox has an incubation period of roughly 12
to 14 days. By the time the first cases of smallpox were diagnosed, the initial group
of cases would probably have infected close contacts, such as family and friends. In
this case, it would be essential to launch an aggressive vaccination campaign to con-
tain the epidemic before the infection spread through the general population in a
series of expanding waves.
THE THREAT OF NATURAL EMERGING INFECTIONS
In parallel to the emerging threat of bioterrorism, the United States faces a grow-
ing problem of infectious disease from natural sources. During the 1960s and 1970s,
powerful antibiotic drugs and vaccines appeared to have banished the major infec-
tious scourges from the industrialized world, leading to a sense of complacency and
neglect of programs for disease surveillance and prevention. Over the past two dec-
ades, however, several well-known diseases, such as tuberculosis, malaria, and chol-
era, have re-emerged in more virulent or drug-resistant forms or have spread geo-
graphically. At the same time, scientists have identified a host of previously un-
known infections, including Legionnaires disease, AIDS, Lyme disease, Sin Nombre
virus, hepatitis C, mad cow disease, Nipah virus, and new strains of influenza.
AIDS was not recognized until the 1980s, yet it now infects some 36 million people
worldwide and kills 3 million annually. Since 1980, the U.S. death rate from AIDS
and other infectious diseases has increased by about 4.8 percent per year, compared
with an annual decrease of 2.3 percent for the 15 years before 1980.3
Several factors have contributed to the problem of emerging infections:
The inappropriate use of antibiotic drugs has fostered the evolution of resistant
strains of tuberculosis and other bacterial diseases, even as the development of
new generations of antibiotics has lagged.
Ecosystem disturbances, such as clearing rainforests for economic gain or
human settlements, have altered the geographical distribution of disease vec-
tors such as rodents, monkeys, and mosquitoes, increasing their contact with
humans.
Rapid population growth and rural-urban migration have given rise to
megacities in the developing world with poor public health infrastructure, en-
abling diseases that once remained isolated in rural areas to spread to large
urban populations.
The collapse of public health systems in Russia and other parts of the former
Communist world have fostered the spread of diseases such as AIDS and drug-
resistant tuberculosis.
3 National Intelligence Council, The Global Infectious Disease Threat and Its Implications for
the United States, NIE 9917D, January 2000 [www.cia.gov/cia/publications/nie/report/nie99
17d.html].
57
The rising volume of tourism, trade, and imported agricultural goods associated
with economic globalization has created new opportunities for the introduction
into the United States of disease vectors and microbial pathogens from other
parts of the world.
Because most U.S. cities are within a 36-hour commercial flight of any part of the
globe, or less than the incubation period of many infectious diseases, infected indi-
viduals may not be visibly ill when they cross a U.S. border. The risk of disease
importations is greatest in major hubs of global commerce such as New York City,
Los Angeles, and Miami. Indeed, the source of the 1999 outbreak in New York of
West Nile encephalitis, a viral disease never before seen in the Western Hemi-
sphere, may have been travelers from the Middle East who were incubating the dis-
ease or a stray infected mosquito on an airplane. Having spread widely over the
past three years, West Nile virus is now permanently entrenched in the United
States.
A future emerging infection introduced into our country could be far more deadly.
In the worst-case scenario, a new pathogen would have the attributes of the 1918
strain of influenza virus, or Spanish Flu, which was highly transmissible through
the air and uncharacteristically lethal to young, healthy people. This disease caused
a global pandemic that claimed more than 20 million lives in less than two years.
The speed at which the U.S. public health system could identify and contain such
an outbreak would mean the difference between life and death for a large number
of Americans.
CURRENT DEFICIENCIES IN INFECTIOUS DISEASE SURVEILLANCE
In the event of a major outbreak of disease-whether the result of a natural emerg-

ing infection or a deliberate terrorist attack-city, county, and state health depart-
ments would be the nations first line of defense, backed up by the medical detec-
tives and virus hunters at the Centers for Disease Control and Prevention (CDC),
the National Institutes of Health (NIH), and other federal agencies. The first indica-
tion of an unusual disease outbreak would be when the initial victims became ill
and sought treatment at emergency rooms and doctors offices. For example, a group
of people living in an urban neighborhood or working in an office building that had
been subjected to a covert bioterrorist attack might initially develop nonspecific, flu-
like symptoms. Detection and containment of a disease outbreak would entail four
basic steps:
1. Recognition and diagnosis by primary health care practitioners.Medical clini-
cians would identify cases of an unusual infectious disease or an undiagnosed syn-
drome (cluster of symptoms). Clinical laboratories would then attempt to identify
the causative agent from patient blood, urine, or other specimens.
2. Communication of surveillance information to public health authorities.Physi-
cians and infectious-disease specialists who had detected an unusual pattern of dis-
ease incidence, such as several patients with the same symptoms, would report their
observations to local or state public health authorities.
3. Epidemiological analysis of the raw surveillance data.Epidemiologists work-
ing for the health department would interpret the disease-surveillance data to deter-
mine the source of the outbreak, the mode of transmission, and the extent of expo-
sure. They would then make recommendations for appropriate treatment and public
health measures (e.g., vaccination) to contain the outbreak.4
4. Delivery of the appropriate medical treatment and public health measures.Pa-
tients seriously affected by the disease would be admitted to hospitals for treatment.
Those infected with a contagious agent would be isolated and all potential contacts
vaccinated (if vaccine is available) to prevent the disease from spreading.
Today, a major epidemic arising either from a natural emerging infection or an
act of bioterrorism would pose serious challenges to the U.S. public health system
in all four areas identified above. Useful lessons can be drawn from the 1999 epi-
demic of West Nile encephalitis in New York City, which revealed some serious gaps
in the existing system of disease surveillance and response. These gaps must be
remedied if the nation is to be better prepared in the future.
The first manifestation of the West Nile epidemic appeared in early July 1999,
when common birds such as sparrows, robins, and crows began to die in unusual
numbers in northern Queens and the South Bronx. One month later, humans in the
same area began to be stricken with encephalitis, or inflammation of the brain, al-
though a possible connection with the bird die-off was not suspected at the time.
The human outbreak was detected when a physician at a hospital in Queens admit-
4 Chemical and Biological Arms Control Institute, Bioterrorism in the United States: Threat,
Preparedness, and Response, Executive Summary, November 2000, p. 12.
58
ted several elderly patients with an atypical form of encephalitis that was accom-
panied by severe muscle weakness. Unable to diagnose this condition, she took the
initiative of reporting the unusual cases to the New York City Department of
Health. Recognizing the possibility of an infectious disease outbreak, health depart-
ment officials then called doctors at 70 hospitals around the city and identified 30
similar cases of encephalitis.5
In early September 1999, the Centers for Disease Controls laboratory for vector-
borne infectious diseases in Fort Collins, Colo., analyzed patient specimens from the
New York outbreak and identified the causative agent as St. Louis encephalitis
virus. Three weeks later, however, the CDC was forced to admit that its initial diag-
nosis had been incorrect and that the infectious agent was actually West Nile virus,
a disease endemic to East Africa and the Middle East that had never before been
reported in the Western Hemisphere. The three-week delay in reaching the correct
diagnosis revealed some significant deficiencies in the U.S. public health system:
CDC scientists investigating the outbreak suffered from tunnel vision by
screening only for encephalitis viruses commonly found in the United States
and neglecting those linked to foreign outbreaks or possibly developed for bio-
terrorism.
CDC scientists repeatedly rebuffed a veterinary pathologist at the Bronx Zoo
who suspected a possible link between the bird and human outbreaks. Commu-
nity newspapers in northern Queens had reported bird die-offs as early as late
June 1999, or five weeks before the first human cases were detected. If the vet-
erinary investigation had begun earlier and been pursued more aggressively, it
is possible that the human epidemic could have been mitigated or even averted.
Throughout the outbreak investigation, communication among the 18 partici-
pating local, state, and federal agencies was complex and difficult, and was
achieved primarily through conference calls lasting several hours.
The various city, state, and federal laboratories involved in the case used dif-
ferent diagnostic techniques, making it difficult to compare results.6
This experience indicates the need for better information-sharing at all levels, as
well as a common database for disease surveillance and laboratory tracking.
BRIDGING THE GAPS
Today, the U.S. response to a serious epidemic resulting from an emerging infec-
tious disease or an act of bioterrorism would be seriously constrained by poor com-
munication and coordination among the diverse array of federal, state, county, and
city agencies responsible for medical care, public health, animal health, law enforce-
ment, and intelligence collection. Efforts to improve interagency coordination face
formidable obstacles, including fragmented jurisdiction and differences in organiza-
tional mission and culture among the various players.
In particular, it is essential to bridge three critical gaps that would seriously im-
pede the nations ability to detect and respond rapidly to unusual outbreaks of dis-
ease. These disconnects exist between: (1) primary care providers and the public
health system, (2) the human and animal health communities, and (3) public health
experts and intelligence analysts.
The Gap Between Primary Care Providers and Public Health Departments
Disease surveillance systems in the United States are patchy in their coverage,
and most rely on reporting by primary health care providers. In the most common
type of surveillance, physicians and nurse-practitioners are required to report cer-
tain infectious diseases or syndromes (undiagnosed clusters of symptoms) to local
health departments. Even when disease or syndromic reporting is mandatory, how-
ever, it is often incomplete. Doctors may be too busy to comply, or they may simply
not know to whom to report.
In the case of West Nile virus, the system worked: reporting by an alert physician
was key to the early detection of the outbreak. Nevertheless, a bioterrorist attack
or a serious natural outbreak would permit little margin for error. If health-care
providers are to be effective sentinels of an epidemic, they must have the necessary
training and professional awareness to include the possibility of emerging infections
and bioterrorism in their differential diagnosis. In addition, they must have direct
communication channels to the public health department and be able to report cases
at any time, day or night.
5 Jennifer Steinhauer and Judith Miller, In New York Outbreak, Glimpses of Gaps in Biologi-
cal Defenses, New York Times, October 11, 1999.
6 Marcelle Layton, M.D., M.P.H., Outbreak Surveillance and Management at the State and
Local Level: Current Realities, presentation at the Second National Symposium on Medical and
Public Health Response to Bioterrorism, Washington, D.C., November 28, 2000, transcript.
59
The Gap Between the Human and Animal Health Communities
Many emerging infectious diseases and putative bioterrorist agents are zoonotic,
meaning that they originate in animals but can also infect humans. Examples of
zoonotic diseases that have been developed as biological warfare agents include an-
thrax, tularemia, brucellosis, plague, and Venezuelan equine encephalitis. In addi-
tion, many natural epidemics have begun in wild or domesticated animals and then
spread to humans, including the outbreaks of bubonic plague in India, Sin Nombre
virus in the U.S. Southwest, Nipah virus in Malaysia, avian influenza in Hong
Kong, and West Nile virus in New York City.
Given the considerable overlap of animal and human pathogens, animals can
serve as useful sentinels for outbreaks of zoonotic diseases. Sheep, for example,
are far more sensitive to anthrax infection than humans. Nevertheless, the West
Nile investigation exposed a major gap between the veterinary and public health
communities. Although the key to identifying the causative agent lay in merging in-
formation from the parallel investigations of the bird and human outbreaks, commu-
nication between animal health and public health agencies was poor. What limited
cooperation occurred was the result of informal personal relationships rather than
official coordinating mechanisms.
This disconnect arose from the fact that the expert communities that address the
health of people, domesticated animals, and wildlife are separated organizationally,
geographically, and jurisdictionally-despite the fact that infectious diseases do not
respect these artificial boundaries. State and local veterinary agencies focus on the
health of domestic pets, horses, livestock, and other economically important species,
but they rarely communicate with agencies involved in safeguarding human health.
Low priority and funding are devoted to the health of wildlife, particularly non-en-
dangered species such as crows and rats, which are the responsibility of parks de-
partments and animal control officers. Monitoring the health of zoo animals is an-
other gray area with no clear leadership, and only six zoos in the United States
employ full-time veterinary pathologists.7
The 1999 outbreak of West Nile encephalitis in New York City indicated that out-
breaks of zoonotic disease in wildlife and zoo animal populations could provide early
warning of an impending human epidemic. In 2001, the CDC agreed to fund a pilot
project for monitoring the spread of West Nile virus by testing blood and tissue
specimens from zoo animals, as well as dead birds and other wildlife found on zoo
property. A centralized database will be established to summarize the results, which
will be made available to the public health surveillance system. For the project to
be effective, the participating zoo pathologists must build a relationship with local
public health officials, and the zoo data must be reliable (using a validated diag-
nostic methodology), consistent, and reported in a timely fashion. If this pilot pro-
gram is successful, it could serve as the basis for further interaction between the
zoo and public health communities for the surveillance of other zoonotic diseases.8
The Gap Between the Public Health Specialists and Intelligence Analysts
The dual threats of emerging infections and bioterrorism pose major conceptual
and technical challenges for the U.S. intelligence community, such as distinguishing
between a natural outbreak of an emerging disease and the deliberate release of a
pathogen by terrorists. In 1984, for example, members of the Oregon-based
Rajneeshee cult used salmonella bacteria to contaminate ten restaurant salad bars
in a trial run of a scheme to manipulate the outcome of a local election by making
large numbers of voters too sick to go to the polls. After 751 people fell ill with food
poisoning, public health investigators concluded initially that the outbreak had re-
sulted from natural sources. The true cause did not emerge until a year later, when
a cult member confessed to the crime.9
During the West Nile investigation, the belated discovery that the causative virus
had originated in the Middle East reportedly raised red flags with biological warfare
analysts at the Central Intelligence Agency (CIA). The reason was an eerie coinci-
dence. In April 1999, Mikhael Ramadan, a self-declared Iraqi defector who claimed
to have worked as a body-double for Saddam Hussein, published a memoir in Eng-
land titled In the Shadow of Saddam in which he asserted that in 1997, the Iraqi
7 Tracey McNamara, Bronx Zoo, presentation at Workshop on Agro-Terrorism, Cornell Univer-

sity, November 13, 2000.
8 Tracey S. McNamara and Dominic Travis, Project Co-coordinators, Surveillance for West Nile
Virus in Zoological Institutions: Report of a Workshop, June 2122, 2001, Lincoln Park Zoo, Chi-
cago.
9 W. Seth Carus, The Rajneeshees (1984), in Jonathan B. Tucker, ed., Toxic Terror: Assessing
Terrorist Use of Chemical and Biological Weapons (Cambridge, Mass.: MIT Press, 2000), pp.
115137.
60
leader had ordered the development of a highly virulent strain of West Nile virus
as a bioterrorist weapon.10 Additional concern was raised by the fact that during
the 1980s, the CDC had shipped an Israeli strain of West Nile virus to a microbiolo-
gist in Basra, Iraq, ostensibly for public health research.11 Nevertheless, further
analysis turned up no evidence that the Iraqis had developed West Nile virus as
a biological weapon.12
The ability of the CIA to assess whether the West Nile outbreak was a deliberate
attack was hampered by the agencys lack of technical expertise: few intelligence an-
alysts have a solid grounding in infectious diseases or epidemiology. Trained epi-
demiologists would have recognized immediately that West Nile virus was a poor
candidate as a bioterrorist weapon because it causes neurological injury and death
in only about 5 to 10 percent of those infected, mainly children, the elderly, and
those with a weakened immune system. Moreover, because the virus is transmitted
to humans by mosquitoes, the putative terrorists would have had to import virus-
infected insects, release them, and wait for the disease to spread-an unlikely sce-
nario.
Although the CIA has recruited a few microbiologists and other scientists for its
analytical staff, this solution is not optimal because scientists need to interact freely
with colleagues from other countries if they are to remain current and well in-
formed. A better approach would be to provide for routine exchanges of people and
training between U.S. public health and intelligence agencies, but differences in or-
ganizational culture have impeded collaboration in analyzing bioterrorist threats.
For intelligence specialists, working closely with medical doctors and epidemiologists
pose risks to the security and effectiveness of their operations. CDC epidemiologists,
for their part, see themselves as members of the international scientific community,
publish their research results, and interact with colleagues from politically sensitive
countries; few are cleared for classified information or have access to encrypted
phone and fax lines. Public health experts also worry that cooperation with defense,
law enforcement, or intelligence agencies could taint their public image. Indeed, any
link between the CDC and the U.S. intelligence community, however innocent, could
undermine the ability of epidemiologists to investigate natural disease outbreaks in
foreign countries.
POLICY RECOMMENDATIONS
New policies are needed to bridge the three gaps identified above in order to im-
prove the nations preparedness for rapidly identifying and containing outbreaks of
disease associated either with emerging infections or bioterrorism.
Bridging the Gap Between Primary Care Providers and Public Health Departments
The Department of Health and Human Services (DHHS) should expand the na-
tional program of awareness training for primary health care providers. To en-
sure timely detection of an unusual outbreak of disease, general practitioners,
emergency-room physicians, and nurse-practitioners must be familiar with the
signs and symptoms of exotic diseases that they would not normally encounter
in their medical practice. Professional medical societies, physician-oriented web
sites, and continuing medical education programs should offer training and re-
fresher courses in the diagnosis and treatment of bioterrorist agents. Such
courses might eventually be made a prerequisite for medical licensing or board
certification.
DHHS should provide grants to state and local public health agencies to estab-
lish simple reporting mechanisms and clear communication channels between
medical practitioners and city, state, or county public health departments, in-
cluding 24-hour telephone or e-mail hot lines. To respond effectively when doc-
tors call, day or night, state and local health departments will need additional
funds to hire more staff members with expertise in infectious diseases, epidemi-
ology, and information technology.
DHHS should increase the number of clinical laboratories associated with public
health departments around the country that are capable of diagnosing exotic
diseases, including suspected bioterrorist agents. Standardized testing protocols
should be developed so that laboratories can easily exchange and compare diag-
nostic findings.
10 Richard Preston, West Nile Mystery, The New Yorker, October 1825, 1999, pp. 90108.
11 Jonathan B. Tucker, Lessons of Iraqs Biological Warfare Programme, Arms Control/Con-
temporary Security Policy, vol. 14, no. 3 (December 1993), p. 238.
12 Vernon Loeb, CIA Finds No Sign N.Y. Virus Was an Attack, Washington Post, October
12, 1999, p. A2.
61
In conjunction with the Department of Defense, DHHS should improve basic
and applied research on bioterrorist threat agents by increasing funding for this
purpose. Knowledge of the pathophysiology, virulence factors, immunology, and
genomic structure of disease agents is vital for the development of improved di-
agnostic tests, therapeutics, and vaccines. Yet such knowledge is limited for the
roughly two dozen classical biological warfare agents, and almost nonexistent
for more than 100 microbial pathogens of potential bioterrorist concern.
DHHS should facilitate prompt and accurate disease reporting by expanding its
current efforts to establish an electronic infrastructure for this purpose at the
city, county, and state levels. At present, few cities have established electronic
systems for the exchange of surveillance data, and roughly half the public
health agencies in the United States are not connected to the Internet. Also
needed is a national electronic information system for exchanging disease-re-
porting data between state health departments and the CDC.
DHHS should attempt to attract more talented individuals into the public
health field by offering mid-career fellowships and internships for medical doc-
tors, both at CDC and at public health departments around the country.
CDC should assist hospitals to incorporate bioterrorist scenarios in their emer-
gency response plans and to carry out frequent dress rehearsals.
Bridging the Gap Between the Human and Animal Health Communities
If the pilot zoo surveillance project for West Nile virus is successful, DHHS and
the U.S. Department of Agriculture (USDA) should expand this program into
a veterinary surveillance network in which unusual patterns of zoonotic disease
in livestock, zoo animals, or wild animals are reported promptly to state and
local public health departments. In some cases, susceptible species living in a
city zoo could serve as sentinels of a covert bioterrorist attack against the
urban population.
DHHS and USDA should support improved communications infrastructure be-
tween veterinary agencies and public health departments, including telephone
and e-mail hot lines, so that unusual outbreaks of zoonotic disease in animals
can be reported to the appropriate public health authorities.
DHHS should fund more epidemiological research on the complex relationships
between human and animal health. Already, the West Nile outbreak has served
as a catalyst for greater interdisciplinary cooperation among veterinarians, phy-
sicians, ecologists, and wildlife biologists.
Bridging the Gap Between Public Health Specialists and Intelligence Analysts
The U.S. intelligence community should recruit more individuals with advanced
training in microbiology, infectious disease, and epidemiology to work as intel-
ligence analysts focusing on biowarfare and bioterrorist threats. In particular,
the Defense Intelligence Agencys Armed Forces Medical Intelligence Center
(AFMIC), the one intelligence organization specializing in infectious diseases,
should be expanded by hiring more technically trained staff. Individuals with
experience in the biotechnology industry are also needed to detect the subtle in-
dicators of clandestine biological weapons production, particularly at dual-use
facilities such as vaccine plants.
DHHS should establish formal exchanges of people and training between public
health agencies such as the CDC and federal intelligence services such as the
CIA, the Defense Intelligence Agency (DIA), the National Security Agency
(NSA), and the Federal Bureau of Investigation (FBI). To this end, DHHS
should create a cadre of specialists in public health and biomedicine who have
security clearances and access to secure communications, such as encrypted
phone, fax, and videoconferencing facilities. These experts could then provide
technical advice to intelligence analysts as needed concerning suspicious disease
outbreaks that could be the result of covert biological weapons use.
CDC should establish a reporting mechanism so that unusual outbreaks of dis-
ease in the United States detected by the Epidemic Intelligence Service (EIS)
are routinely reported to the FBI and other law-enforcement agencies.
In conclusion, the natural emergence of a deadly and contagious infectious disease
such as the Spanish Flu of 1918, or the deliberate release of anthrax or some other
pathogen as an act of bioterrorism, could result in a serious loss of life and social
disruption. Unless corrected, the communication gaps that currently exist among
the U.S. medical, public health, animal health, and intelligence communities could
seriously delay detection of the resulting disease outbreak and impede the prompt
response needed to minimize its medical impact and social consequences.
Bridging these gaps will be essential if the nation is to be better prepared to deal
with the dual threats posed by emerging infections and bioterrorism. The good news
62
is that despite the anxieties we all share today about this issue, the U.S. govern-
ment can take practical steps to reduce the threat. Improved infectious disease sur-
veillance, combined with other preparedness measures and continued research, may
make it possible in the not-too-distant future to render biological weapons in the
hands of terroriststo borrow a phrase from President Ronald Reaganimpotent
and obsolete.
Senator HARKIN. Thank you. Now we will go to Dr. Stephen
Cantrill, associate director, Department of Emergency Medicine,
Denver Health Medical Center. Dr. Cantrill served as the Regional
Medical Coordinator for Denvers participation in Operation Top
Off, which simulated a bioterrorist incident, which I mentioned in
my opening statement a while ago. He has also been involved in
weapons of mass destruction training for the Denver area.
Dr. Cantrill, welcome.
STATEMENT OF STEPHEN CANTRILL, M.D., ASSOCIATE DIRECTOR, DE-
PARTMENT OF EMERGENCY MEDICINE, DENVER HEALTH MED-
ICAL CENTER
Dr. CANTRILL. Mr. Chairman, and members of the subcommittee,
thank you. I consider it a privilege to have been asked to testify
before this subcommittee today on our experience with Operation
Top Off and on some local perspectives and concerns about our
countrys efforts to improve our domestic preparedness to deal with
the possibility of a bioterrorism event.
Even before our participation in Top Off, a major issue of concern
in our preparedness was achieving adequate involvement in train-
ing on the part of the general medical and public health commu-
nities. This oversight has been partially remedied by recent CDC
grants to State public health departments, but lack of awareness
training and preparedness in the general medical community con-
tinues to be a major issue.
This also represents a major paradigm switch for the public
health sector, as they have not been trained in medical aspects of
disaster management and medical incident command, which are
two areas of major importance in adequately dealing with a biologi-
cal terrorism attack. We must somehow stimulate interest and seek
incentives for the individuals in these communities so they will
avail themselves of WMD training.
We must also stimulate and encourage training and integration
between hospitals and State and local departments of public
health, especially in the areas of information systems, communica-
tion systems, and coordinated test readiness. This task will be
made especially difficult by the decades-old contraction of the pub-
lic health infrastructure in this country, which must be reversed.
It will also be complicated by the recent adoption of the Federal
HIPAA regulations governing excessive confidentiality of patient
information that could potentially be used to detect the early stages
of bioterrorist attack, and most domestic WMD preparedness hos-
pitals and other health care institutions have been the forgotten
components.
Most hospitals are financially strapped due to low levels of reim-
bursement for care. At this time there are few public policy incen-
tives to encourage or enable health care institutions to invest in
WMD planning or training. With a large number of dollars going
63
to other sectors, we must not forget our hospitals and public health
institutions to assist them in their preparedness.
An additional concern is the illusion shared by many that our
health care system could adequately deal with a significant WMD
incident. In this area, I must respectfully disagree with Secretary
Thompson, as you heard me quoted earlier. Due to multiple pres-
sures, including fiscal, regulatory, and inadequate available staff,
our hospitals today have no surge capacity. They could not adjust
to a sudden increase in patient load without degenerating into
chaos.
This has been clear to those of us in health care, and it is well-
demonstrated by Operation Top Off. This problem would only be
partially alleviated by the dispatching of our Federal resources to
a specific locale, and could be of no help if terrorists opt to involve
dozens of metropolitan areas simultaneously. This problem is fur-
ther complicated by regulations such as the Centers for Medicare
and Medicaid Services, the old HCFA, EMTALA regulations.
Our national capability to limit the spread of a WMD infectious
agent is also inadequate in many areas. For example, with an esti-
mated 42 percent of our population susceptible to smallpox, and
with the potential case fatality rate of 20 percent or greater, our
national lack of adequate smallpox vaccine and smallpox
immunoglobulin would severely limit our ability to contain the
spread of this dreaded disease where it is used as part of a ter-
rorist attack. Such an attack would make our 1918 influenza pan-
demic truly look like a walk in the park. The ongoing problems
with the manufacture and availability of anthrax vaccine are also
troubling.
Another concern is the potential lack of coordination between fed-
erally funded efforts such as the Metropolitan Medical Response
System, the MMRS, and systems that are already in place. Every
effort must be made to have these new initiatives interdigitate with
plans and systems that already serve these metropolitan areas.
When possible, it would be better to augment current systems rath-
er than constructing competing systems.
The Federal Government should also increase its research efforts
in some other potential aspects of dealing with a WMD incident.
For example, what are the best techniques to use for the emer-
gency vaccination of thousands of people in a metropolitan area?
How do we expeditiously distribute prophylactic antibiotics to a
million people in 48 hours? These and other operational issues
must be researched and the results disseminated and incorporated
into the planning for all major metropolitan areas.
All said, I do not want to appear negative or ungrateful. I ap-
plaud the Federal Governments effort at initiating and encour-
aging local training and planning for a potential bioterrorism or
other WMD event. I do feel we have made significant strides in the
area of WMD awareness and preparedness. We now have an oppor-
tunity to fine-tune and improve our efforts for domestic prepared-
ness.
In closing, I would like to thank you, Mr. Chairman, and the sub-
committee for this opportunity to discuss some of the issues that
are of concern to the medical and public health communities in our
preparations to combat domestic terrorism at the local level.
64
PREPARED STATEMENT
Mr. Chairman, this concludes my testimony. My written testi-

mony does include other comments concerning the national disaster
medical system, and the National Pharmaceutical Stockpile. I am
happy to address any questions you or the subcommittee members
may have.
Thank you.
PREPARED STATEMENT OF DR. STEPHEN V. CANTRILL
Mr. Chairman and members of the Subcommittee, I am Dr. Stephen Cantrill, As-
sociate Director of Emergency Medicine at Denver Health Medical Center in Denver,
Colorado. I have been involved in local preparation and training for weapons of
mass destruction for the last four years and was a participant in the planning and
execution of Operation TopOff in May, 2000. I consider it a privilege to have been
asked to testify before the Subcommittee today on our experience with Operation
TopOff and some local perspectives and concerns about our countrys efforts to im-
prove our domestic preparedness to deal with the possibility of a bioterrorism event,
even though I do so with a heavy heart, due to the recent terrorist events that have
shocked our country.
As you may know, Operation TopOff was a Congressionally mandated, no-notice,
multi-site disaster exercise to evaluate our countrys ability to deal with multiple
simultaneous disasters from weapons of mass destruction. We in Denver had the
good fortune to be selected to participate in this exercise as the site for a simulated
bioterrorism attack with pneumonic plague. This exercise involved initial exposure
of more than 2500 patients with thousands of fatalities and tens of thousands of
ill patients. Even before our participation in this exercise, a major issue of concern
in our preparedness was achieving adequate involvement and training on the part
of the general medical and public health communities. Many efforts to date have
focused on training and material support for police, fire and emergency medical
services. This includes the training efforts under the Nunn-Lugar-Domenici Act that
were directed towards first responders with no attempt to engage the general med-
ical community nor the state and local public health sectors. This oversight has been
partially remedied by recent CDC grants to the state public health departments, but
lack of awareness, training and preparedness in the general medical community
continues to be a major issue. The message must be clearly conveyed that our
health care system is of central importance in our fight against weapons of mass
destruction. Medicine and public health must be called to the table and included
and supported in the planning and training for dealing with weapons of mass de-
struction. This will be a major paradigm switch, especially for the public health sec-
tor, as they have not been trained in the medical aspects of disaster management
and medical incident command, two areas of major importance in adequately deal-
ing with a biological terrorism attack. Current efforts in these areas have been
largely done pro-bono by a small number of dedicated individuals with little interest
or enthusiasm on the part of the general medical or public health communities. We
must somehow stimulate interest and seek incentives for the individuals in these
communities so they will avail themselves of WMD training. We must also stimulate
and encourage training and integration between hospitals and state and local de-
partments of public health, especially in the areas of information systems, commu-
nication systems and coordinated tests of readiness. This task will be made espe-
cially difficult by the decades old contraction of the public health infrastructure in
this country, which must be reversed. It will also be complicated by the recent adop-
tion of the federal HIPPA regulations governing excessive confidentiality of patient
information that could potentially be used to detect the early stages of a bioterrorist
attack.
In most domestic WMD preparedness, hospitals and other health care institutions
have been the forgotten components. For example, hospitals are not currently al-
lowed to receive any Department of Justice or CDC grant monies to deal with their
WMD needs including drugs and equipment that would be specifically used for a
WMD event. Most hospitals are financially strapped due to low levels of reimburse-
ment for care. They cannot pass on these WMD preparedness costs to normal pa-
tients. At this time, there are few public policies or incentives to encourage or en-
able health care institutions to invest in WMD planning or training. The federal
government must engage and support the medical and public health leadership in
65
building the critical elements of WMD preparedness. With the large number of dol-
lars going to other sectors, we must not forget about our hospitals and public health
institutions to assist them in their preparedness.
An additional concern is the illusion shared by many that our health care system
could adequately deal with a significant WMD incident. In this area I must respect-
fully disagree with Secretary Thompson. Due to multiple pressures, including fiscal,
regulatory, and inadequate available staff, our hospitals today have no surge capac-
ity. They could not adjust to a sudden increase in patient load without degen-
erating into chaos. This has been clear to those of us in health care and was well
demonstrated by Operation TopOff. Unfortunately, this problem is not well appre-
ciated in many governmental circles and by the lay public. This problem would only
be partially alleviated by the dispatching our federal resources to a specific locale
and could be of no help if terrorists opt to involve dozens of metropolitan areas si-
multaneously. This problem is further complicated by regulations such as the Cen-
ters for Medicare and Medicaid Services (the old HCFA) EMTALA regulations that
require a medical screening examination for all who present to an emergency de-
partment but do not allow for suspension or alteration of these requirements under
the duress of a patient load that could balloon to ten to twenty times normal.
Dealing with a massive increase in hospital admissions in a metropolitan area
during a WMD attack could theoretically be alleviated through the activation of the
National Disaster Medical System, with transfer of patients to distant participating
hospitals. It is not clear to us in the trenches, however, that this system, which was
designed more for dealing with natural disasters, could adequately ameliorate the
problems seen with a WMD incident. Would remote hospitals, whose participation
is voluntary, be willing to accept contagious patients suffering from plague? The ca-
pacity and design of this system should be reassessed in light of these issues.
Several areas in which WMD preparedness work has begun could benefit from
some additional attention. The National Pharmaceutical Stockpile maintained by
the CDC is a major step forward in our ability to deal with a WMD attack. How-
ever, the packaging of the drug items in the stockpile remains largely oriented to-
wards fiscally advantageous stock rotation, not efficient distribution once the stock-
pile arrives at the locale of the terrorist attack. Also, significant thought should be
given to increasing stocks of several of the drugs at a local level: a 12 to 24 wait
would render most of the utility of the treatments for a chemical attack unhelpful
as most of the severely afflicted patients would be dead. Also, more effort must be
made to incorporate state-of-the-art treatments that are widely used in Europe
(such as hydroxocobalamin for the treatment of cyanide poisoning) into our medical
armentarium in the United States.
Our national capability to limit the spread of a WMD infectious agent is also inad-
equate in many areas. For example, with an estimated 42 percent of our population
susceptible to smallpox and with a potential case-fatality rate of 30 percent or great-
er, our national lack of adequate smallpox vaccine and smallpox immune globulin
would severely limit our ability to contain the spread of this dreaded disease were
it used as part of a terrorist attack. Such an attack would make our 1918 influenza
pandemic, with a case-fatality rate of 2 percent and more than 670,000 deaths, truly
look like a walk in the park. The ongoing problems with the manufacture and avail-
ability of anthrax vaccine are also troubling.
Another concern is the potential lack of coordination between federally funded ef-
forts, such at the Metropolitan Medical Response Systems (MMRS) and systems
that are already in place. Every effort must be made to have these new initiatives
interdigitate with plans and systems that already serve these metropolitan areas.
Unfortunately, often the federal funding stream has been haphazard, uncoordinated
and operated in a counter-productive fashion, thwarting successful integration. We
must be careful not to create new systems that not only conflict with current in-
place systems, but also may not have sufficient ongoing maintenance funding to suc-
cessfully survive if they are not integrated into current plans and organizational
structures. When possible, it would be better to augment current systems, rather
than constructing competing systems.
This process, by its very nature, will take time. It is not something that we can
throw a lot of money at and expect instant success, but rather will require a long-
term, ongoing commitment. It would be most helpful, if it could be achieved, for all
regional funding to have a single point of contact. There should also be an increased
emphasis on involving regional emergency managers in this integration process. Our
goal should not be to develop a separate system to deal with nuclear- chemical-bio-
logical events, but rather to have this preparedness be part of the existing systems
that we have in place to deal with all other disasters. Hopefully, FEMAs announced
role as an integrative force in this area will address some of these deficiencies.
66
The federal government should also increase its research efforts in some of the
practical aspects of dealing with a WMD incident. For example, what are the best
techniques to use for the emergent vaccination of thousands of people in a metro-
politan area? How do we expeditiously distribute prophylactic antibiotics to a mil-
lion people in 48 hours? In Denver, during Operation TopOff, we exercised a dem-
onstration distribution center for the dispensing of prophylactic antibiotics to the
general population. With 60 workers, we could dispense to only 3360 patients in a
24 hour period. Extrapolating this to the need to deliver prophylaxis to a population
of one million patients within a 48 hour period, we would need 1400 distribution
centers utilizing 84,000 workers. Clearly not doable. These and other operational
issues must be researched and the results disseminated and incorporated into the
planning for all major metropolitan areas.
All said, I do not want to appear negative or ungrateful. I applaud the federal
governments efforts in initiating and encouraging local training and planning for
a potential bioterrorism or other WMD event. I do feel we have made significant
strides in the area of WMD awareness and preparedness. Exercises such as Oper-
ation TopOff have proven invaluable to stimulate interest and planning for the un-
thinkable. We now have an opportunity to fine tune and improve our efforts for do-
mestic preparedness.
In closing, I would like to thank you, Mr. Chairman, and the Subcommittee, for
this opportunity to discuss some of the issues that are of concern to the medical and
public health communities in our preparations to combat domestic terrorism at the
local level. Mr. Chairman, this concludes my testimony. I am happy to address any
questions that you or the Subcommittee members might have.
Senator HARKIN. Thank you, Dr. Cantrill. Next, we will go to Mr.
Jerome Hauer. Mr. Hauer is director of the Crisis and Con-
sequences Management Group at Kroll Associates. Previously he
was director of New York Citys Office of Emergency Management,
where he was responsible for drafting the citys emergency re-
sponse plans to national and manmade disasters, including biologi-
cal terrorism.
Mr. Hauer, welcome.
STATEMENT OF JEROME M. HAUER, MANAGING DIRECTOR, CRISIS
AND CONSEQUENCES MANAGEMENT, KROLL ASSOCIATES
Mr. HAUER. Thank you, Mr. Chairman. I appreciate the invita-
tion to be here today, and I, too, would like to commend you for
your leadership in holding these hearings. As you mentioned, I am
former Director of the Mayors Office of Emergency Management,
and I also served as an advisor to Secretary Thompson on national
security issues. I would like to spend the next few minutes address-
ing the issues State and local governments confront as they plan
for managing the consequences of biological terrorism.
Let me begin by stating the obvious. A biological incident is sig-
nificantly different from that of a chemical incident. A chemical in-
cident is a lights and sirens response by fire departments, police
departments, and emergency medical services.
A biological incident, however, evolves over days, and may not be
evident until victims begin to die. It will be recognized by primary
care providers and changes in health care utilization, and not your
first responders. Preparing for a biological incident at the local
level, therefore, does not entail protective suits and decontamina-
tion units, but,rather, training, surveillance, and developing plans
to support the needs of the community following the incident.
A window of opportunity exists following the release of a biologi-
cal agent. If a State and local government is prepared, they can re-
duce morbidity and mortality, and if they are unprepared at the
time of detection of an incident, people will die unnecessarily. The
67
key is ensuring that the window of opportunity is as large as pos-

sible.
Let me take a few moments to talk about three areas, training,
surveillance, and logistical support. I will start with training. Most
primary care practitioners have never seen a case of anthrax or
smallpox. The symptoms would likely be missed, or thought to be
those of more common illnesses like cold or flu. For a patient with
anthrax, this delay could mean the difference between receiving
care that could save their life, or being sent home with a misdiag-
nosis and then returning in 48 hours and being untreatable.
Training is essential for these care providers in two realms. The
first is in recognizing these diseases and symptoms of other threat
agents, and the second is in knowing what to do when there is a
suspicion that something out of the ordinary has occurred.
Few physicians or nurses know who to call in their local health
department when they have a concern about an unusual cluster of
disease. Most contact with the local county health department is a
three-part disease or reporting form for a limited number of report-
able diseases. It is important we develop strong links between the
medical community and the public health community, which brings
me to my next point.
The public health infrastructure in this country has been allowed
to deteriorate over the past 2 decades. The key to recognizing that
something out of the ordinary has occurred is by having a sensitive
surveillance system in place that monitors the health of the com-
munity and sets off alarms when something out of the ordinary is
occurring.
In New York, we developed a system called the DHI, or daily
health indicators, that tracks a number of activities. Any spike in
any one of these indicators requires investigation by the depart-
ment of health. Things such as EMS runs for respiratory or abdom-
inal symptoms, admissions to the hospitals through the emergency
rooms, sale of antidiarrheal and cold and flu medication over the
counter, and influenza-like illness in nursing homes, are monitored
and an algorithm is in place that causes an alarm when a spike
in any one of the indicators occurs.
The data is also linked to a geographic information system so
that patterns can be relayed on a map, and geographic distribu-
tions of the patients can be discerned. This system is simple in its
design, and can be used in any city or county or State in the
United States. Once it is determined that an incident has occurred,
cities must be prepared to manage massive numbers of patients
and have plans in place to distribute antibiotics or vaccinate people
in a very short period of time.
The logistical support necessary for this will have to come from
State and Federal resources. No city in this country can handle the
demands that will be placed on them during one of these events.
Let me give you a quick example as I conclude my remarks.
In New York, we modeled two scenarios, one in which we went
door-to-door to give out antibiotics, and the other in which we set
up PODs, or points of distribution so that people could come in to
pick up antibiotics. To go door-to-door in Manhattan alone I would
need over 40,000 people to give out antibiotics in a 36-hour period.
68
To set up PODs, I would need about the same amount of people,

but I could give antibiotics out to the entire city.
In either case, these resources are simply not available in New
York. I have not yet discussed the large number of medical per-
sonnel that would be required to treat those who have succumbed
to the disease. We have developed plans to set up alternate care
facilities to take the load off hospitals and casualty collection points
to treat or isolate the overflow of patients.
In summary, I believe that we must continue to build our stock-
piles of vaccines and antibiotics at the national level, as it is im-
practical for cities and States to do this. HHS is moving forward
on this aggressively. Congress, however, must make a commitment
to reinvigorate the public health system of this Nation, beginning
with the development of sophisticated surveillance systems in all
State and local health departments to detect a terrorist attack. Cit-
ies and counties should feed their data into State health depart-
ments and State health departments should feed their data into
CDCs so cross-jurisdictional patterns can be detected.
Mr. Chairman, it is important we as a Nation focus on these
threats. We have underestimated the level of sophistication that
our enemies have. We know that the capability to manufacture
these weapons exists in countries that are not our friends.
Mr. Chairman, that concludes my remarks, and I would be happy
to answer any questions you have.
Senator HARKIN. Thank you very much, Mr. Hauer, for your
leadership in this area.
Now we turn to Dr. Patricia Quinlisk, medical director and State
epidemiologist for the Iowa Department of Health. She is the
former President of the Council of State and Territorial Epi-
demiologists, and is one of its primary consultants on bioterrorism
preparedness. She is also a member of the Gilmore Commission
which is assessing the capabilities for responding to terrorist inci-
dents involving weapons of mass destruction. Dr. Quinlisk, wel-
come.
STATEMENT OF PATRICIA QUINLISK, M.D., M.P.H., MEDICAL DIREC-
TOR AND STATE EPIDEMIOLOGIST, IOWA DEPARTMENT OF
HEALTH
Dr. QUINLISK. Thank you very much. I am honored to appear
today before the subcommittee dealing with this very important
issue, and I am particularly honored to testify before you, Mr.
Chairman, one of Iowas Senators and an important long-time ad-
vocate of public health, for which we deeply appreciate your leader-
ship.
Since the horrible attacks of September 11, we have seen from
news and media reports that some members of the public are be-
coming so frightened by the possibility of a terrorist attack involv-
ing biological/chemical agents that they are purchasing antibiotics
and gas masks in a mistaken belief that these measures will pro-
tect them from harm. However, since many of these agents are
colorless, odorless, could be released covertly and, most impor-
tantly, especially with biological agents, would have an incubation
period before symptoms occur, an individual would have to be tak-
ing these antibiotics or wearing their gas masks continuously for
protection.
69
Therefore, the best defense against grievous harm that would re-
sult from one of these chemical or biological attacks is a robust
public health system at the local, State, and Federal level. This
system would be able to detect rapidly that an attack had occurred,
investigate the nature of that attack, diagnose the agent involved
rapidly, immediately institute responses that would get the right
treatment to those who are ill and the right prevention measures
to those who are exposed, and implement other protection strate-
gies for everyone else.
But right now, the Nations public health system is not robust.
It is fragmented, ill-equipped, and seriously understaffed. There
are not trained epidemiologists, those people who detect, inves-
tigate, and stop epidemics. There are not trained laboratorians or
other critical personnel.
Over the past 3 years, CDC has had a bioterrorism preparedness
cooperative grant program for State and local health departments.
This is an important beginning, but it is only that, a beginning.
Last year, Congress enacted the Public Health Threats and Emer-
gencies Act to focus on building our Nations public health infra-
structure.
This has resulted in a consensus process, now accelerated, about
needed core capacity and an appropriate assessment tool, but to
date there has been no funding for States to conduct these assess-
ments, which must be done in order to determine how to be fully
prepared and where we have weaknesses. While I lack the re-
sources of a documented assessment, I have been asked to provide
this subcommittee with a description of what Iowa would need to
be prepared for a terrorist attack. I am confident that a formal re-
view would confirm much of what I am going to tell you, and I am
also confident that Iowas needs are typical of all the States.
Iowas public health system needs strengthening in five major
areas: Workforce, particularly in epidemiology, laboratories, com-
munications, information systems, and planning. With regard to
workforce, the Iowa Department of Public Health estimates it
would need at a minimum 25 additional people at the State level
alone to address the present needs.
Currently, we only have one person whose job it is to enhance
surveillance for possible terrorist agents, to coordinate education
with health care professionals in over 100 hospitals on identifica-
tion and reporting, to organize an emergency alert system, and ev-
erything else that is needed. A similar number of people would be
needed at the local level. We estimate that this would cost approxi-
mately $8 million.
I would like to emphasize that finding and attracting trained in-
fectious disease epidemiologists to fill these types of positions will
be difficult, particularly in this environment of intense competition
with other States. Iowa tried to hire a bioterrorism coordinator. It
took us over a year and three rounds of position announcements
and interviews to find someone. I urge that the subcommittee give
immediate attention to the problems of the public health workforce
training, particularly epidemiology.
Iowas public health laboratory needs are ongoing for support for
equipment, materials, staff, and training, and needs to add chem-
ical terrorism capacity. This alone will cost another $1 million.
70
An additional $500,000 to $1 million would be needed to build a

comprehensive, rapid, and secure communications system. I will
give you just two other examples of our basic communication needs.
Right now in Iowa, only about 10 of the 99 counties have anyone
on call 24 hours day, 7 days a week.
The State public health laboratory system currently reports dis-
eases to me, the State epidemiologist, on paper through the U.S.
mail system. The National Electronic Disease Surveillance system
is a priority both for CDC and epidemiologists. It is designed to
technically integrate as many as 100 separate data systems cur-
rently used in our Nations public health system. It will allow the
rapid identification of disease trends which may signify biological
or chemical attacks much clearer and more quickly across States
and regions.
CDC estimates this program should be funded at a minimum of
$50 million. Iowa has received only planning and assessment fund-
ing, and will need $1 million to implement and integrate a disease
information collection and analysis system. I cannot stress enough
the critical nature of planning, including regular testing with exer-
cises for preparedness for biological and chemical attacks. Iowa, as
well as 39 other States, receive no funding to address this formal
need. I would guess $200,000 per year would be needed for this ac-
tivity.
In summary, looking only to Iowas public health systems needs
to prepare and respond to a biological or chemical attack, the total
comes to approximately $11.5 million. This estimated amount is
much closer to Iowas real minimum needs than to the funding that
we have already received under the current preparedness pro-
grams. This level of funding also needs to be made available over
a period of several years, because it will take time to build the sys-
tem, particularly in light of a workforce that is not prepared. After
this, significant funding must continue to keep the system main-
tained. This is consistent with the $1.4 billion mentioned earlier.
PREPARED STATEMENT
One final point. By building a robust public health system, we

will be building a multiuse system for diseases and situations that
are occurring every day, such as emerging diseases like West Nile
virus, which was now discovered in Iowa 2 weeks ago, the pre-
dicted pandemic flu, as well as every-day food poisoning outbreaks.
Thus, when and if a terrorist event occurs, the system will be well-
tested and familiar to those involved in ensuring an effective and
efficient functioning system in a crisis.
Thank you again for the opportunity to provide testimony on this
important matter.
PREPARED STATEMENT OF DR. PATRICIA QUINLISK
Mr. Chairman, Members of the Subcommittee, I am Patricia Quinlisk, MD, MPH,
Medical Director and State Epidemiologist for the Iowa Department of Public
Health. I am here today not only representing the Iowa Department of Public
Health, but also the Council of State and Territorial Epidemiologists (CSTE) as a
former Council President and as one of its primary consultants on bioterrorism pre-
paredness. In addition, my written statement includes comments provided by the
71
Association of Public Health Laboratories (APHL) on the need for enhanced labora-
tory capacity at the state and local level.
I am very honored to appear before the Subcommittee today, and particularly you,
Mr. Chairman, as one of Iowas Senators and an important, long-time advocate for
public health. The Iowa Department of Public Health deeply appreciates your lead-
ership.
I am also very honored to provide testimony on one of the most critical issues fac-
ing our nation: terrorism preparedness. The comments I will provide are from the
perspective of a state health department and our specific and immediate, as well
as long-term needs, to be prepared for a serious terrorist event involving biological
or chemical agents.
BIOLOGICAL AND CHEMICAL TERRORISM: STRATEGIC PLAN FOR PREPAREDNESS AND
RESPONSE.
Over a year ago, the national Biological and Chemical Terrorism: Strategic Plan
for Preparedness and Response was developed with input from experts from across
the public health spectrum. This strategic plan is based on the following five focus
areas, each of which is a primary function of public health:
Preparedness and prevention;
Detection and surveillance;
Diagnosis and characterization of biological and chemical agents;
Response; and
Communication.
Working in coordination, federal, state and local public health agencies will also
rely on other groups in the health and medical community to fully address each
area to ensure preparedness. Examples are:
Medical research centers,
Health-care providers and their networks,
Professional societies,
Medical examiners,
Emergency response units and responder organizations,
Safety and medical equipment manufacturers,
U.S. Office of Emergency Preparedness and other Department of Health and
Human Services agencies.
In the state of Iowa, the Iowa Department of Public Health has been given state-
wide responsibility in four areas: traditional public health functions, medical serv-
ices, mass casualty, and radiologic preparedness. I believe that most state public
health agencies have similar preparedness responsibility in addition to their more
traditional functions. Thus, in the above list, Iowas Department of Public Health
not only needs to coordinate with the listed groups that are state based, but also
has primary responsibility to ensure their preparedness.
The national plan identifies nine critical steps in preparing for Chemical and Bio-
logic attacks. I am going to name each step, and describe in each case where Iowa,
a typical state, stands.
STEPS IN PREPARING FOR BIOLOGICAL AND CHEMICAL ATTACKS
Enhance epidemiologic capacity to detect and respond to biological and chemical

attacks.Right now, Iowa depends entirely upon physicians and other health
care providers to recognize and respond to illness in a possible victim of a bio-
logical or chemical attack. Yet after the events of two weeks ago, I received
many phone calls from medical professionals asking what they should be look-
ing for, and how to report suspicious illnesses. I would guess that the majority
of Iowa health care providers do not know what to look for, how to send labora-
tory specimens for diagnosis of these rare diseases and whom to notify if they
do suspect something. And yet this is the base of our present surveillance sys-
tem. We need help in providing these professionals with education and training,
diagnostic tools, and communication systems for rapid reporting.
Supply diagnostic reagents to state and local public health agencies.Right now
in Iowa, if a large attack using anthrax occurred, there is only one laboratory
that has the reagents, i.e. laboratory supplies, to rapidly and correctly diagnosis
this disease. And the supply of these critical laboratory reagents would be de-
pleted within hours.
Establish communication programs to ensure delivery of accurate information.
Right now in Iowa, I, as the state epidemiologist, have no easy means to alert
the health care system, or our public health department, other than personally
calling someone. I am able to fax or send e-mail messages, but if an incident
occurs after working hours, I would have to call. Only about 10 of the 99 local
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health departments in Iowa have someone on call 24 hours-a-day, 7 days-a-
week. Two years ago, when a petting zoo bear was diagnosed with rabies on
a Saturday, there were several health departments with victims living in their
counties that I could not contact until the next Monday morning when their of-
fices opened. Also, the systems I do have available are not secure, thus I would
not be able to send or receive confidential information without jeopardizing the
privacy of that information. Our state public health laboratory, located in Iowa
City, sends confidential patient information via the U.S. postal service, on
paper, to insure safety.
Enhance chemical and bioterrorism-related education and training for health-
care professionals, as well as traditional first responders.Right now in Iowa,
public health only has one person with the responsibility to address training for
over 100 hospitals, all health care providers, and emergency medical personnel
regarding biological and chemical terrorism and medical/public health coordina-
tion. This is obviously inadequate. Everyday, we receive requests to give semi-
nars, lectures, and provide information on these diseases and the appropriate
response to terrorist events. We are lucky in Iowa to have a statewide fiber op-
tics network, which we used two days ago to broadcast a lunch time briefing
on terrorism to almost 200 sites, and thousands of health care providers. But
since only the basic information can be addressed in an hour, this can only be
the beginning of our educational efforts.
Prepare educational materials that will inform and reassure the public during
and after a biological or chemical attack.Since terror, rather than illness and
death, is the primary goal of terrorist, one of the best tools we have against this
is timely, accurate and believable information. Iowa has only just begun to work
with the media on this issue, yet this may be one of the most important actions
we take during an attack.
Stockpile appropriate vaccines, drugs and antidotes.It is estimated that it will
take approximately six to twelve hours for some of the federal stockpiles of crit-
ical medical supplies to reach Iowa, we believe it is necessary to survey Iowas
hospitals and pharmacies to understand the resources that would already be
here prior to an attack. Yet this takes time and personnel, which we do not cur-
rently have.
Establish molecular surveillance for microbial strains, including unusual or
drug- resistant strains.The use of DNA fingerprinting of bacteria is critical
since those destined to become ill may disperse across the US after exposure.
Thus laboratories must be able to link infections they identify with those occur-
ring in other states to understand the scope of the attack. However, right now
this is only occurring with about six bacteria, most of which would not be used
in a biologic attack.
Support the development of diagnostic tests.Since some chemicals, such as tox-
ins that a terrorist might use, do not persist in the human body, we need to
develop tests for surrogates to enable us to quickly recognize what chemical was
being used so that we can protect others by providing antidotes.
Encourage research on antiviral drugs, vaccines and bioassays for chemical inju-
ries.Right now there is no effective treatment for smallpox. Research is need-
ed to develop treatment, as well as preventive vaccines, for some of these dis-
eases.
As the Iowa examples above illustrate, in order to implement many of these crit-
ical preparedness steps, capacity at the state and local level must be built. Con-
sensus about what constitutes core public health capacity to prepare and respond
to bioterrorism, and how to assess that state by state, is now occurring within the
public health community.
DEVELOPING NATIONAL CONSENSUS ON CORE CAPACITY TO PREPARE AND RESPOND TO
BIOTERRORISM
Dr. Jeffrey Koplan, Director of the Centers for Disease Control and Prevention
(CDC), gave an address over the Public Health Training Network Broadcast to state
and local public health officials a week after the September 11th attacks. His topic
was the importance of strengthening the nations public health infrastructure to pro-
tect the publics health. He stressed seven priority areas for capacity building at the
state and local level that have been developed through a consensus process. These
are, briefly:
(1) Public health workforce.a well-trained, well-staffed, fully prepared public
health workforce is the most fundamental need in Iowa and in all states;
(2) Laboratory capacity.to produce timely and accurate results for diagnosis and
investigation
73
(3) Epidemiology and Surveillance.to rapidly detect health threats;
(4) Information systems.that are accessible, rapid, permitting effective analysis
and interpretation of health data and provide public access to health information;
(5) Communication.that is rapid, secure, two-way flow of information that in-
cludes the ability to provide timely, accurate information to the public and advice
to policy-makers in public health emergencies;
(6) Policy and evaluation.routine evaluation of how effective we are at rapidly
detecting health threats and making improvements; and
(7) Preparedness and response.developing response plans and then regularly
testing them to maintain a high-level of preparedness.
The enactment of the Public Health Threats and Emergencies Act (PHTEA) last
year has provided an authorized process for accomplishing these seven priorities.
This process has now been accelerated, and is concentrating first on bioterrorism
preparedness. CDC is about to publish a document identifying the core capacities
needed by state and local health departments for terrorism preparedness and re-
sponse. It reflects the input of epidemiologists, laboratories, state and local health
officers, and many others in the public health practitioner community.
The next step is for CDC to provide grants to states to assess themselves against
these core capacities. Assessment tools have been developed for this purpose and
CSTE has provided its capacity assessment tools for epidemiologic surveillance and
response to CDCs Public Health Practice Program Office (PHPPO) for use in the
assessment phase (see attached document). However, at this time, there are no fed-
eral resources for conducting this assessment of bioterrorism capacity even though
it is clear that every state should undertake this task.
The final step authorized under PHTEA is for CDC to provide grants to state and
local health departments to fill any gaps they have identified in their assessment
process. Again, while there has been three years of bioterrorism preparedness fund-
ing flowing to state and local health departments via CDCand this has been a
critical beginning for most statesit has been far too little to begin to fill the gaps
that are going to be identified more systematically in the capacity assessment
phaseif and when that phase is funded.
SOME SPECIFICS ON WHAT CONSTITUTES CORE EPIDEMIOLOGIC CAPACITY IN STATE
HEALTH DEPARTMENTS
To make the core capacity assessment process concrete let me give you a specific
example. The first goal listed for CDCs document Bioterrorism Preparedness and
Response Core Capacity Project 2001, now in final draft, is: Surveillance and Epi-
demiologic Investigation: The public health system monitors community health sta-
tus to detect the presence of critical bioterrorism agents and characterize the public
health emergency. Under this goal, the first objective is: Ensure early detection of
an outbreak through prompt and systematic collection and interpretation of timely
patient-based and healthcare utilization data. Under this objective are a number of
indicators in three groups. I will provide and discuss a few of these:
Legal authority to collect personal information.Iowa is in the administrative
process of making diseases and syndromes that may be the result of a delib-
erate act using biologic or chemical agents notifiable. This allows us the author-
ity to collect appropriate medical information, however, it does not ensure the
timely identification and reporting of these diseases and syndromes.
Disseminate notifiable disease information and reporting requirements on a peri-
odic basis.As mentioned earlier, Iowa has no means to immediately alert all
its health departments in 99 counties, over 100 hospitals, its public health lab-
oratory, and other key entities such as community health centers and large phy-
sician group practices on either a routine basis, or in the event of a possible
terrorist attack, especially during non-office hours. At the very least, every local
health department in Iowa should have coverage 24/7. All of them need pagers,
and secure communications systems to send confidential information to the
state health department. Also, a system for secure, rapid communications with
Iowas health care systems, including laboratories is critical, yet even the states
public health laboratory reports its findings on paper via the U.S. Mail service.
Establish systematic data collection protocols that monitor community health in-
dicators (e.g., aberrations in utilization trends or syndrome-based presen-
tations).Iowa has no systematic surveillance for syndromes, instead we are re-
lying on the traditional passive surveillance system and two sentinel surveil-
lance systems. We have no capacity to monitor aberrations in, for instance,
emergency room utilization trends based on syndromic presentations. This is
now being done in New York City requiring 70 individuals with some epidemio-
logic training who are conducting syndromic sweeps of all major emergency
74
rooms in the city. This is funded under CDCs bioterrorism grants for special
epidemiologic projects. It requires intensive efforts to educate health care pro-
fessionals, set up systems to do surveillance and report the findings, and per-
sonnel to assess the incoming data for indications of a possible terrorist event.
Iowa, like most states, does not even come close to having this capacity.
Ensure healthcare providers understand the medical effects and public health
consequences of diseases caused by bioterrorism agents.As mentioned earlier,
two days ago, the Iowa Department of Public Health presented health care pro-
fessionals with a briefing on terrorism. We asked the hospitals to pull out their
emergency plans, most of which address disasters such as airline crashes, and
review them for ability to respond to a biological or chemical attack. Items that
need to be assessed include isolation beds for infectious disease and decon-
tamination facilities for chemical injuries. This is just one hour for healthcare
providers when they need on-going, regular communication and assessment as-
sistance from either their state or local health department, regular, on-going
education of their physicians about biologic and chemical terrorist agents and
their lab personnel about what and how to handle specimens. What is needed,
immediately in Iowa, is ten additional masters level, or equivalently experi-
enced bachelors level, public health personnel to liaison, continually, with
Iowas hospitals and other health care providers: community health centers,
health clinics, major physician group practices, etc. This will insure timely re-
sponse to requests for training and information, a knowledgeable cadre of pro-
viders, good reporting of syndromes and diseases, and coordination of the com-
munications systems. In addition, each large local health department in Iowa
needs at least one person to coordinate the health and medical aspects of ter-
rorism response with the law enforcement agencies, fire and HAZMAT depart-
ments, and emergency management in their county.
Train public health, infection control, and clinical staff to collect and rapidly
analyze and interpret surveillance data.As already noted, at the state health
department level, Iowa needs 10 additional, trained individuals to connect to
the medical care system to educate, monitor, assess, and collect data in an on-
going fashion. Iowa also needs three additional epidemiologists at the state level
to conduct training of staff at local health departments, conduct on-going, active
surveillance, including analysis of disease clusters, and to coordinate commu-
nications and investigations.
IOWAS OTHER PRESSING TERRORISM PREPAREDNESS NEEDS
In addition to the above examples of Iowas current capacity gaps when compared
with core bioterrorism capacity goals, Iowa has great needs in several other areas.
Iowa is a major agricultural state, but it currently has only one public health veteri-
narian assigned to the state health department. Iowa needs at least one additional
public health veterinarian to set up and conduct active surveillance on animals to
monitor for West Nile Virus, and economically devastating diseases such as Bovine
Spongiform Encephalapathy (or mad cow disease) and Foot and Mouth Disease. The
latter would be a very effective bioweapon in a state like Iowa or in any state with
a large agricultural base. Also, surveillance for animal diseases can serve as the ca-
nary in the mine and give us advance notice for diseases that can affect human
health.
Iowas medical examiners office, which has been given the responsibility for mass
casualty response, urgently needs one nurse administrator full-time to: 1) organize
medical examiner teams for response to a mass casualty event; 2) survey available
resource such as refrigerator trucks, x-ray equipment, autopsy supplies; 3) conduct
and coordinate surveillance for unusual deaths; and 4) prepare for coordination of
information and possible notification of victims families.
Also, Iowa needs one doctoral level person who can educate medical professionals,
coordinate communications, and provide consultation to the medical care system
with regard to chemical weapons. This will free up the one person currently as-
signed to chemical weapons to conduct full time surveillance for chemical related in-
juries. Right now, Iowa is relying on our poison control center for information about
chemical injuries and possible attacks. This is haphazard at best.
Iowa is currently trying to develop a critical response capacity with Medical As-
sistance Disaster Teams. These teams, critical in rural states that have no major
metropolitan centers like Iowa, will be recruited from the medical care system. They
will be able to move in a moments notice anywhere within Iowas borders, or sur-
rounding states, in the case of a terrorist attack involving mass trauma, or illness,
to assist the local medical care system since it will take at least 2436 hours before
federal teams can get to Iowa. The Iowa Department of Public Health has absolutely
75
no additional resources to coordinate and train these teams, or to pay for their de-
ployment if needed.
Another pressing need in Iowa, and many other states as I have learned from my
colleagues around the country, is more a problem of perception than funding. Public
health has to be seen by all as a major player, and having expertise, thus needing
to have control over some issues, especially in bioterrorist events. We need to be at
the table, not an after thought. Last Saturday, a town hall meeting was put to-
gether in Iowa, to address Terrorism: Risk and Response. Five U.S. Congressmen,
police, fire, a city manager, the CIA, former FBI, etc were invited. Not one single
public health or even a practicing health care professional was invited. We continue
to be forgotten.
Finally, last week, Iowa has created an Office of Medical and Public Health Dis-
aster Preparedness. The director will coordinate all of the various public health and
medical elements in the state health department that might respond to a natural
or deliberate disaster. This is a function every state needs to address. We have hired
a director, but have taken her from the Emergency Medical System (EMS) unit,
which the health department also administers. EMS will have to fill this vacated
position in the current climate of terrorism preparedness. The new director will
eventually need to hire additional staff to manage all of the required duties. Each
county in Iowa with 500,000 or more population also needs a full-time bioterrorism
coordinator in the local health department.
CDC GRANTS TO IOWA FOR BIOTERRORISM PREPAREDNESS
Iowa has received a total of $953,181 over three years under CDCs Public Health
Preparedness and Response for Bioterrorism Cooperative Agreement Awards pro-
gram. Of this amount, $545,430 has been used to help Iowas public health lab meet
the specifications of a Bio Level 3 laboratory. But more funding is needed to keep
the lab sustainedadequately equipped, with appropriate reagents for example, and
trained staff. In addition, the lab needs to add an entire chemical terrorism capa-
bility. Finally, funding is needed to make it part of the National Laboratory System
with enhanced communication and collaboration with Iowas independent and hos-
pital based clinical labs, and secure electronic connection to the state health depart-
ments epidemiology office, at a minimum.
Iowa received no epidemiologic and surveillance funding in the first year of CDCs
grant program and only $96,000 in Year 2. This money has been used to hire an
epidemiology nurse for my office, the state epidemiology office, but we need three
more epi-trained individuals. It took three rounds of position announcements and
interviews to find and hire this person; hiring additional trained individuals is
clearly going to be very difficult and we are competing intensely now with many
other states. The Year 2 epi-surveillance funding has also been used to pay for the
one-hour broadcasted terrorism seminar for the medical system described earlier,
and to provide support for the newly hired terrorism coordinator. Iowa has just re-
ceived $170,000 for epidemiology and surveillance for the current fiscal yearYear
3. While we are still working on specific plans, we will be attempting to hire more
epi-trained individuals.
Iowa also just received its first Health Alert Network grant for $143,000. This
money will be used to facilitate training and education of our states public health
workforce and to begin to address a system for emergency alerts. It will clearly not
be enough to establish the communication network for local health departments and
medical systems that is needed across the state that I have described earlier.
And, as I mentioned before, Iowa has received no planning moneythe logical
first step in bioterrorism preparedness.
These funding levels are not unusual. A colleague in Texas, who helped CDC de-
sign its bioterrorism planning grant, also has not received any planning funding. He
was so concerned about preparing his state that he dropped all his other public
health duties to work with his staff to plan for a biological or chemical attack. This
is typical of dedicated individuals in state health departments where there is a
chronic shortage of trained staff. This shortage has also been well documented in
federal reports on health workforce needs.
I also know that my Texas colleague has been seeking, at a minimum, 33 addi-
tional trained staff for the state health department alone to conduct surveillance
and provide response. Only about six of Texas major cities have an identified epi-
demiologist on staff in their health department. This slows down the ability to de-
tect disease and puts additional burden on the state to cover. And these deficiencies
do not include concerns the department may have about the needs of its public
health laboratory, or the continuing need for overall planning, and testing that plan
76
in regular training exercises. Texas needs, therefore, mirror Iowas only on a larger
scale.
The past three years of federal funding has been critical to begin to build the na-
tions public health terrorism preparedness and response. But it is simply not
enough when states like Iowa and Texas cannot get planning money, and can only
get a fraction of what they need for epidemiologic surveillance and response, labora-
tory capacity, and secure, electronic communications. This also does not address
other related issues such as information systems that are accessible, and allow for
rapid analysis and interpretation of health data as Dr. Koplan noted. The National
Electronic Disease Surveillance System, or NEDSS, is an important CDC effort in
collaboration with states, to allow the technical integration of a myriad separate
data bases that currently obfuscate important disease trends, or service utilization,
and so slow down our ability to detect outbreaks of disease and quickly respond.
NEDSS is a CDC and a CSTE priority and it needs to be fully funded at $50 mil-
lion.
COMMENTS FROM THE ASSOCIATION OF PUBLIC HEALTH LABORATORIES
Iowa needs to enhance its public health laboratory system. This is also true for
all of our states public health laboratories. The public health laboratory is a critical
component of the national and state surveillance for bioterrorism. In order to be pre-
pared for bioterrorism public health laboratories need safe facilities, trained per-
sonnel, modern equipment, rapid assays, and communications tools. Courier services
are also needed to move specimens to the public health laboratory. To prepare for
chemical terrorism our states need containment laboratories, trained personnel and
equipment to perform rapid screening for toxic chemicals.
To prepare Iowa, and our nations public health laboratories, we recommend en-
hancement of the following three programs: The Laboratory Response Network, the
National Laboratory System and the development of a Chemical Terrorism Pre-
paredness program.
The Laboratory Response Network (LRN) is critical to the success of the United
States response to terrorism. The national Laboratory Response Network (LRN) is
composed of county, city, state, and federal public health laboratories, and was es-
tablished to help public health laboratories across the nation prepare for and re-
spond to acts of terrorism. This network of laboratories can accept specimens and
samples from hospitals, clinics, the Federal Bureau of Investigation (FBI) and other
law enforcement groups, emergency medical services, the military, and other agen-
cies. With adequate resources, this multi-level network will be able to function effec-
tively even if airplane travel is simultaneously grounded. During the recent events
in New York City and Washington, D.C., if there had been simultaneous attacks
with physical and bioterrorism agents, patient samples could have easily been trans-
ported over the ground to adjacent states.
Definitive identification of agents of biologic terrorism in both an overt or covert
attack will depend on laboratories having technical capabilities, equipment and
trained personnel. Laboratories must be able to identify a broad range of potential
agents including organisms that could be used to compromise the food supply, water
or air. Conventional identification methods are now in place and more rapid meth-
ods are being evaluated prior to implementation in public health laboratories. There
is no reliable alternative to the testing by the network laboratories. The hand held
devices that are widely touted by industry often provide false positive results and
false negative results and cannot be relied upon to provide accurate testing at this
time. Therefore, the LRN should not only be sustained it must be augmented. In
order to prepare the LRN member labs at the local, state, and federal level an addi-
tional $50 million is needed.
The National Laboratory System (NLS) is an essential component of a laboratory
preparedness plan for biological and chemical terrorism. The National Laboratory
System (NLS) is a demonstration program funded by the Centers for Disease Con-
trol and Prevention (CDC) in response to the growing threat to public health posed
by bioterrorism, food-borne diseases, and emerging infectious diseases. A major goal
of the NLS is to facilitate communication between public health laboratories and the
medical community and hospital/independent laboratories. Accurate and timely lab-
oratory detection is critically important to identify, track, and limit public health
threats like biologic and chemical terrorism. Today, most diagnostic testing for infec-
tious agents occurs in 170,000 private hospital or commercial laboratories nation-
wide. These facilities will very likely be the primary sites for detecting an act of bio-
terrorism or the introduction of an unusual infectious agent into a community. Im-
provements are needed in the integration of public health laboratories and private
clinical laboratories. These two types of laboratories have independent yet com-
77
plementary roles to safeguard public health. To reach this goal, the CDC, in con-
junction with the Association of Public Health Laboratories, has been piloting the
National Laboratory System within the states of Minnesota, Michigan, Nebraska
and Washington. The National Laboratory System focuses on building enhanced col-
laboration, communication and coordination between Public Health Laboratories
and private clinical laboratories to develop a network of alert and responsive labora-
tories. The National Laboratory System must be expanded to all states to maximize
our nations preparedness to detect and provide public health interventions for infec-
tious disease outbreaks. Through improvements in communication, collaboration,
and coordination, the NLS initiative is successfully providing links to the public and
private sectors necessary for an effective response to terrorism, emerging infectious
disease, antimicrobial resistance, and food borne diseases. Mr. Chairman, Iowa
needs to be part of a National Laboratory System. An additional $50 million is need-
ed to fully implement the NLS in all 50 states.
For Chemical Terrorism Preparedness, expanding the number of laboratories able
to handle chemical agents and agents present in environmental samples is essential.
The likelihood that chemical agents will be used for terrorist purposes is high. Un-
like biological agents, chemical agents can produce immediate effects; are cheap,
easy to use, stable, and can be precisely delivered; and can be easily, efficiently, and
rapidly dispersed. Terrorists can use thousands of commercially available chemicals.
These chemicals can be purchased throughout the world. These include herbicides,
blood agents, choking agents, blistering agents, and nerve agents. Currently only
five state public health laboratories (New York, Virginia, New Mexico, California
and Michigan) have received funding and training from the CDC, and are beginning
to serve as surge capacity laboratories for CDC chemical terrorism analyses of
clinical specimens. At present there are no efforts to coordinate laboratories testing
environmental samples for evidence of terrorist attacks. Additional public health
laboratories, strategically located throughout the country, must be prepared for the
threat of chemical terrorism. At a minimum, a total of $25 million additional dollars
is needed to enhance and expand public health laboratories testing clinical speci-
mens for chemical terrorism. Additional dollars would also be needed to fully imple-
ment a program of testing for environmental samples.
SUMMARY AND RECOMMENDATIONS
(1) Capacity Assessment Needs.In order to provide you with a well-documented

cost estimate of Iowas needs with regard to capacity for terrorism Iowa would need
to conduct an adequately funded assessment. A consensus process for this is well
underway, but has received no funding to date. I understand that CDC believes
each state will need $1 million to conduct an assessment of capacities under three
categories authorized by PHTEA: bioterrorism, antimicrobial resistance, and major
naturally occurring infectious diseases. I do not know if CDC would estimate it will
cost less to limit this to bioterrorism, including chemical and radiological agents. I
would guess that it will cost Iowa a minimum of $750,000 to conduct a thorough
biological and chemical terrorism preparedness and response assessment.
(2) Workforce Needs.Again, I am reluctant to make specific funding rec-
ommendations until and when an adequately funded assessment is concluded. How-
ever, the Department of Public Health estimates it will need, at a minimum, 25 ad-
ditional peopleat the state level aloneto address the needs of the epidemiologic
surveillance system as described in this statement. This is estimated to cost $2 mil-
lion in salaries, taxes, and benefits. But each additional person will also need office
space, a computer, educational materials, and various support staff including data
analysis and computer technicians. This will cost an estimated additional $2 million.
We also estimate that this amount will be needed at the local health department
level, for a total of $8 million for an investment in the right kind of trained work-
force for Iowa. I would like to stress that finding and attracting trained, infectious
disease epidemiologists to fill these positions will be difficult, if not impossible, par-
ticularly in an environment of intense competition with other states. Great attention
needs to be given immediately to public health workforce training, particularly epi-
demiology.
(3) Laboratory Needs.I cannot speak specifically for Iowas public health labora-
tory, and it would obviously be included in a capacity assessment process, but it is
clear that it will need on-going support for equipment and materials, staff and train-
ing, and will need to add chemical terrorism capacity. As the APHL comments make
clear, Iowas lab should also be part of a National Laboratory System that will im-
prove its connection to the numerous clinical labs and tie it electronically to the
state epidemiology office, at a minimum. I would assume that this level of need is
approximately $1 million.
78
(4) Communication Needs.The $143,000 grant to begin to establish a Heath
Alert Network in Iowa is an important beginning. The communication goal must be
comprehensive, rapid, and timely. This means it needs to be electronic, two-way,
and secure and include all major medical system sites, state and all local health de-
partments, the public health lab, the states clinical labs, and the CDC. This needs
to be supplemented with a system that allows immediate ability to contact at least
one person in each county health department on a 24 hour, seven day-a-week, avail-
ability. Again, I am hesitant to estimate the cost of a comprehensive communica-
tions system for Iowa. Some of this cost is built into the estimated cost for workforce
needs, and laboratory needs. But I would guess an additional $500,000$1 million
would be needed for the whole system.
I would like to mention here the importance of CDCs Epi-X program. The mission
of Epi-X is to provide rapid, secure communication about outbreaks and other acute
or emerging health events among public health officials. It is a secure Web-based
system with participants from CDC, state health departments, and the military.
Epi-X also provides emergency notification by: telephone, including office, home, and
cell; fax; pager; e-mail. During the September 11th attacks, Epi-X provided secure
communications for state epidemiologists to post information on surveillance and re-
sponse activities for 500 public health officials around the country, including the
U.S. military. As Iowas state epidemiologist, I have found Epi-X to be extremely
effective. CSTE urges the Subcommittee to provide $10 million in annual funding
for Epi-X.
(5) Information Systems Needs.Every state has now received at least $85,000 in
funding for assessment and planning under the National Electronic Disease Surveil-
lance (NEDSS) program. Several states are progressing to the next stage, the inclu-
sion of element development, at an average cost of $300,000 and even finished, pro-
totype testing at an average cost of $1 million. The NEDSS program is designed to
technically integrate as many as 100 separate data systems currently used by the
nations public health system so that data analysis can be done rapidly, across data
sets, across regions including multi-states, and so that mandated reporters, such as
physicians, will find reporting diseases significantly simplified. This is a priority
program for CDC and CSTE; it will make trends that may signify a biological or
chemical attack much clearer more quickly. It will also, eventually, permit analysis
of many other disease trends including environmental exposures and chronic dis-
ease. CDC estimates the NEDSS program should be funded at a minimum of $50
million. Iowa has only received planning and assessment funding and would need
an estimated $1 million to fully implement an integrated data collection and anal-
ysis system.
(6) Planning Needs.I cannot stress enough the critical nature of planning, in-
cluding real and regular testing of the plan, to be prepared for a biological or chem-
ical attack. Iowa, as well as 39 other states, has received no funding to address this
foremost need in the nations effort to combat terrorism. Again, this is an unpre-
pared, and undocumented estimate of what Iowa needs in this area, but I would
guess $200,000 per year, should be committed to this activity.
(7) Bioterrorism Response Needs.This would need careful review under a well-
funded assessment process, but I would anticipate that if Iowa can put in place the
workforce, laboratory, communications and information systems identified here as
needed for bioterorismand chemical terrorismthis is the system, with regard to
public health, that would also respond in the event of an attack. The workforce
would need to be immediately expanded in an emergency to conduct an outbreak
investigation in the case of infectious disease, or evaluation of victims exposed to
toxins in the case of a chemical attack. But we could draw upon epidemiological
staff in other areas to accomplish this. CDCs Epidemic Intelligence Service teams
would likely supplement these efforts. Iowa would additionally draw upon the Med-
ical Assistance Disaster Teams we hope to create to fill the gap that would nec-
essarily occur before federal D-MAT and D-MORT teams could arrive. None of these
estimated expenditures address the deficiencies of our medical system, which will
need to develop surge capacity for infectious disease patients and victims of chem-
ical attack including decontamination facilities. It also does not include the expense
involved in conducting a survey, which Iowa feels it must do now, of its hospitals
and pharmacies to determine the resources our state has on hand immediately in
case of attack. Again, obtaining and distributing national stockpile pharmaceuticals
will take at least 24 hours.
Total Estimated Needs for Iowa to Prepare and Respond to a Biological or Chem-
ical Attack.Looking only at Iowas public health system needs, items 16 above,
the total comes to $11,450,000. This does not include the specific response needs
noted in item 7. It does include preparedness for a chemical, as well as a biological
attack. It also includes some items that may be one-time expenditures, or periodic
79
expenditures. But this estimated amount is much closer to Iowas real minimum
needs than the funding we, or any state, has received under the current CDC bioter-
rorism preparedness program. This level of funding also needs to be made available
over a period of several years, as it will take time to build the system, particularly
the right workforce. After that, significant funding must continue to keep the sys-
tem maintained.
Estimated National Need.CSTE is aware of a proposal by Senator Kennedy,
Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee
to provide $625 million to improve the ability of state and local health agencies to
monitor, contain, and respond effectively to the effects of a bioterrorist attack. CSTE
believes this is much closer to the real needs of the nation in confronting an enemy
that could strike with terror using biological or chemical weapons.
I would like to make one final point about the extended value of strengthening
public health while preparing for a bioterrorist attack. By continuing to build to-
ward a robust comprehensive public health system, we will be building a multi-use
system that will be used for diseases and situations that are occurring everyday.
For example, responding to emerging diseases like West Nile Virus, which was dis-
covered in Iowa two weeks ago, the predicted pandemic flu and the more mundane
food poisoning outbreaks. Thus, when and if a terrorist event occurs, the system will
be familiar to those involved which will help ensure efficient and effective func-
tioning in a crisis.
Thank you again for this opportunity to provide testimony on this important mat-
ter before the Subcommittee. I am pleased to answer any questions you may have.
Senator HARKIN. Thank you very much, Dr. Quinlisk, for your
statement.
Now we turn to our final panelist, Dr. Archer, who is here on be-
half of the National Association of County and City Health Offi-
cials. Dr. Archer is the director of Kansas City Health Department,
and is chairman of the Bioterrorism and Emergency Response Task
Force of the National Association of County Health Officials. He
has been involved in bioterrorism and emergency preparedness
planning in Kansas City, and has helped to develop guidance and
performance standards on bioterrorism preparedness for local pub-
lic health systems.
Welcome, Dr. Archer.
STATEMENT OF REX ARCHER, M.D., M.P.H., DIRECTOR, KANSAS CITY
HEALTH DEPARTMENT
Dr. ARCHER. Thank you. On behalf of those almost 3,000 local
health departments, we really want to thank you for your leader-
ship on this issue. Are we prepared for bioterrorism? One of the ad-
vantages of being last is, I do not have to repeat everything in my
written comments, so I am going to jump right into this. As said
earlier, we are not unprepared, but we are certainly underpre-
pared, and I think everybody testified that it is at the local level
that we are most vulnerable. We have been working very strongly
on partnerships with CDC, with a lot of different partners on this,
but it does not get you where you need to go if you do not have
all the resources.
One of the advantages here is that every dollar we spend at the
local level for preparedness really can improve our overall public
health threats response. As mentioned, I have been working with
a number of partners on a core set of capacities that are needed
at the State and local level. That work is what our needs at the
local level is based on.
It might surprise you that in almost every city, in fact almost
every community that I am aware of in the United States, we have
more deaths from infectious diseases, natural causes, than we have
from motor vehicle crashes, burns, drowning, falls, and homicides
80
combined. So again, everything that we need we should be already

doing, and we should be recognized as public safety agencies, but
in the last 2 decades this system has really been crumbling.
We have a 50-percent increase in deaths from infectious disease
over the last couple of decades. We have been doing a lot of innova-
tive activity at the local level, attempting to take all of these silos
of grants and create generalists so that we have surge capacity to
be able to handle an outbreak, but our field staffs still have to han-
dle over 800 cases in a year in regards to being able to do all of
the contact tracing and to make sure that that disease is not
spreading to others.
We believe that that needs to be cut in half in regards to those
caseloads. We do 24-hour-7 days a week coverage, but we dont pay
the people anything for it. It is just an added responsibility that
they have to carry the pager.
I want to go down the kind of staffing we need. Obviously, we
need a full-time bioterrorism coordinator. We are almost a one-half
million population. In the metropolitan area we are 1.8 million. We
have 9 or 10 hospitalsone may be closingbut we believe we
need a liaison staff person from our health department at these
hospitals that would be working with them on infectious diseases,
on reportability, and on training.
All the kinds of issues that have been talked about, such as co-
ordination, that have been trouble at times at the Federal level,
have been issues at the local level. Any dollars that come into the
local community, we need to be aware of them. We need to coordi-
nate that activity, and if we are doing training of physicians,
nurses, and other providers, public health needs to coordinate and
be at that training table, because then the providers will report to
you if they see a face and they know who you are when they are
being trained.
This is not one-time training, either. We all know that this has
to be ongoing. We need a full-time training coordinator because of
that.
In addition, as I mentioned, we need to double our epidemiolog-
ical field staff; that is another 12 individuals. We believe we need
at least four data entry people to be able to maintain our Health
Alert Network and other systems. Those broadcast-back systems
are not any good if the numbers are not correct and are not up-
dated.
In addition, we believe that we need a full-time high-level com-
puter professional, because actually the first responders are actu-
ally probably going to be in the pharmacies. If you think about it,
people self-medicate first, and as was mentioned earlier, with Mil-
waukee or other places, it is actually in the pharmacies that you
will run out of the anti-diarrhea medication or the cough medicine.
So if you add that up, that is about 30 people. Take that up at
a per capita rate across our Nation, and that is probably around
13,000 additional local public health workers that we need in this
country. So I could say very conservatively, at least let us get
10,000 up and running right now.
81
PREPARED STATEMENT
I know you share our sense of urgency, and it is really a shame

that we have had to take this catastrophe to pull us together to
move forward on this. We must keep our military defense strong,
but it is now obviously even more apparent that we have to keep
our public health system strong, and unless somebody comes up
with a better way to name this, I think what we need to call this
is really Operation Bio Shield, and that is improving our infra-
structure for public health, for all of these purposes.
Thank you.
PREPARED STATEMENT OF DR. REX ARCHER
Good morning, Mr. Chairman and members of the Subcommittee. I am Rex Ar-
cher, MD, MPH. I am Director of the Kansas City Health Department in Missouri.
I chair the Bioterrorism and Emergency Preparedness Committee of the National
Association of County and City Health Officials (NACCHO). NACCHO is the organi-
zation representing the almost 3,000 local public health departments in the country.
I have been deeply engaged in bioterrorism and emergency preparedness planning
in Kansas City. I have also participated in national work to develop guidance and
performance standards in bioterrorism preparedness for local public health systems.
I am here today to tell you about some of the lessons we have learned in our work,
and how much farther we need to go.
Senator Harkin and Senator Specter, you have been leaders in providing funding
for public health preparedness and in recognizing how local health departments
serve on the front lines in battling public health crises of all types. Local public
health agencies are the first responders on the ground in a bioterrorism incident.
We are particularly grateful for your support of the Health Alert Network. CDC
used this system, although it is not yet complete, at mid-day on September 11 to
advise public health officials to begin heightened disease surveillance.
Are we prepared for bioterrorism? Not nearly enough. Local public health depart-
ments have long experience in responding to infectious disease outbreaks and other
local emergencies with public health implications. We have made progress and
learned important lessons about the challenges of bioterrorism preparedness in the
last few years. But we have a very long way to go to achieve the capacities we need
to detect and respond to an act of bioterrorism as quickly as possible, to prevent
the spread of disease and save as many lives as possible.
Our nations bioterrorism preparedness activities have been limited, but we are
not starting from scratch. We have some experience and some results from funding
that Congress has appropriated thus far that I will share with you. In addition, we
have a legislative framework in place for expanding our general public health pre-
paredness. The Public Health Threats and Emergencies Act of 2000, which has not
yet been funded, establishes a process for systematically defining what our federal,
state and local public health systems need to do, for assessing what they already
can do, and for filling in the gaps. Every component of the public health system
plays a vital role. State and local public health agencies must collaborate closely,
sharing information and resources. Properly equipped laboratories and data man-
agement and communication systems are essential, as is leadership and support
from the Centers for Disease Control and Prevention (CDC).
We urge you to provide ample funding to allow bioterrorism preparedness to move
forward swiftly. The Chairman of the authorizing committee, Senator Kennedy, is
requesting sums that we are confident will provide an excellent, reasonable start.
We fully believe that, when a systematic assessment permits us to quantify more
precisely the national needs for staffing and systems, we will find that developing
and maintaining the state and local public health preparedness capacities the na-
tion needs will require more than a one-time boost.
LESSONS LEARNED FROM THE HEALTH ALERT NETWORK PROGRAM
The Health Alert Network (HAN) program was established to enable rapid, secure
communications among local and state public health agencies and CDC. In addition
to helping fund electronic communications systems in 37 states and 3 large cities,
HAN has funded three Local Centers for Public Health Preparedness. These are
model programs that have explored how local bioterrorism preparedness can be
82
built, emphasizing cutting-edge uses of information technology. These programs
have shown us what can be done with additional resources and were ready to apply
the lessons learned in many more jurisdictions.
The three model programs are in Denver, Colorado, DeKalb County, Georgia (near
Atlanta), and Monroe County, New York (Rochester). CDC has spent $4 million total
on these three centers, beginning in fiscal year 2000. The Centers used the funds
to develop their capacities in three areas: advanced communication and information
systems; advanced operational readiness assessment; and comprehensive training.
These three public health agencies already had advanced levels of information tech-
nology. To build on that, Monroe County developed software to link various local
networks together to enable secure communications across multiple agencies in-
volved in bioterrorism detection and response. They are installing desktop com-
puters in hospital emergency departments to enable instant reporting of unusual
disease syndromes. In Denver, new handheld devices are being piloted and will be
used in data collection for disease surveillance and field investigation of outbreaks.
Disease investigators will be able to input data directly from the field into the state
reportable disease system. DeKalb County has built the capacity to acquire elec-
tronic data from a variety of sources, including 911 systems, county emergency med-
ical services, the medical examiners office, and local hospitals. This is being used
to develop a web-based notifiable disease reporting system that will enable early
recognition of unusual events.
The three centers are also using unique approaches to training, so that bioter-
rorism preparedness training is available and appropriate for all the people who
need it. Denver has developed Web-based curricula to address personal protective
equipment, epidemiology and disease surveillance, victims assistance, and hospital
logistics and operational readiness. As these modules are used, they will also be
evaluated to see how well they work and what more is needed. DeKalb and Monroe
counties have devoted some resources to assessing types of preparedness training
among private physicians, hospital staff, fire departments, law enforcement, and the
medical examiner, as well as public health staff. All three Centers have gained ex-
tensive experience developing and conducting tabletop exercises and other prepared-
ness drills in which hospitals and all other first responders have participated.
The lessons are still coming in. What have we learned so far? First, we have
learned that the real challenges to improving technology are not really technical.
Rather, they are related to training, institutionalizing the use of new technology,
and finding the funding to sustain it.
Another important lesson, which many other jurisdictions that have undertaken
bioterrorism preparedness planning also have learned, is that partnerships between
public health agencies, health care providers, and the traditional first responder
communities, such as fire, police and emergency services, can be built and are es-
sential to progress. When many public and private agencies in a city or county have
to work together to respond to an emergency, they need to know each other and to
have planned together far in advance. Local surveillance and response systems
wont work unless we have people to use them and the people who use them know
exactly what to do and gets lots of practice in doing it.
Finally, we have demonstrated what we really already knewthat preparing for
bioterrorism also prepares us for other public health emergencies. The three Local
Centers are stronger public health agencies in many ways, not just in their ability
to address bioterrorism. The systems for disease surveillance, for communication, for
data management, for interagency planning, for mobilizing the community to re-
spond, are the same for bioterrorism as they are for any other disease outbreaks.
They have multiple uses, extending even to improving our abilities to address other
public health problems more effectively. Every dollar we spend on bioterrorism pre-
paredness will pay off in countless other ways.
The three model centers are showing us what can be done. It is important to note
that they embarked upon building state-of-the-art bioterrorism preparedness with
better, more advanced technology and programs than the average local public health
department has. Many local public health agencies will need significant resources
just to get to the level that the three model centers had before they started their
upgrades.
PROVIDING GUIDANCE TO LOCAL AND STATE PUBLIC HEALTH AGENCIES
NACCHO has also been working with CDC and other public health partners on
a national level to define just what public health agencies need to prepare for and
respond to a bioterrorist act and to provide them solid guidance. We have developed
a set of core capacities and some ways to measure whether an agency has achieved
them. Defining measurable objectives is an essential part of achieving preparedness.
83
Setting standards will enable us not only to assess where we stand, but also to as-
sure that funds are spent prudently, and that the outcome ultimately will be an ef-
fective system serving the countrys needs.
These core capacities include (but are not limited to):
Routine surveillance and epidemiologic investigation
Enhanced surveillance during a suspected emergency
Laboratory work to identify or rule out biological threat agents
Rapid reporting of laboratory results to the right people and agencies
Communications networks among the agencies involved in emergency detection
and management
Methods and systems to receive and transmit data needed to make emergency
management decisions
Plans and protocols for communicating to the public
Integrating the public health emergency response into a communitys overall
emergency response planning
Activating and enforcing emergency public health and infection control meas-
ures, including mass distribution of medications or vaccination, closure of public
places, travel restrictions, and evaluation and handling of the dead.
The next step is to enable states, counties, cities and towns to transform this
framework into their own practical action plan for bioterrorism preparedness and
response. One of our highest priorities now must be to give states and localities the
resources to take this next step and to develop more tools to help them. Evaluating
their progress against measurable objectives is critical to assuring accountability.
A CASE STUDYBIOTERRORISM PREPAREDNESS IN KANSAS CITY
We have never had a bioterrorism incident in Kansas City and I hope we never
do. Nonetheless, we lose more lives from infectious diseases in Kansas City than we
do from all motor vehicle crashes, burns, drownings, falls, and homicides, combined.
The local public health department is just as essential a public safety agency as the
police or the fire department. At the moment, though, we have just one duty officer
on call for nights and weekends, after regular business hours. We cant afford 24/
7 coverage for urgent situations or emergencies.
I am proud of some innovative steps we have taken to maximize the resources
we do have. Our funding for disease surveillance systems has been based on pro-
grammatic funding, one disease at a time. We have eliminated these silos and
have developed a fully integrated surveillance staff that handles everything from
HIV to measles. Yet we need additional staff to make their workload more manage-
able and to provide for surge capacity in the event of an epidemic. Each member
of our epidemiology field staff handles 800 case reports of reportable disease a year,
doing whatever is necessary to locate and interview patients, trace contacts, assure
that infectious disease is being contained as much as possible. We need to double
our staff to reduce the workload to 400 cases a year and have enough trained people
to work 24/7 in a crisis.
Let me tell you what I think my agency needs in terms of human resources to
have an effective system for detecting and responding to a bioterrorist event. First,
we need a full-time bioterrorism coordinator to work with other city agencies and
the health care community. Kansas City has nine hospitals. I would like to place
one full-time infectious disease officer in each institution, to work with hospital staff
in bioterrorism training and emergency planning, to assist with their ongoing infec-
tion control work, particularly antimicrobial resistance, and to be in place as the ac-
tive liaison with the health department in any public health emergency. We need
a full-time trainer in the health department to train both health department em-
ployees and the medical care community on bioterrorism surveillance and response.
We need a full-time public information officer to develop working communication re-
lationships with the media and the public, so that mechanisms are in place when
we must help the public understand and deal with an emergency. We need a full-
time high-level computer professional to manage the funds and contracts for build-
ing an electronic disease reporting system and four lower-level data entry and proc-
essing staff. We need twelve additional epidemiology field staff. Including super-
visory and support staff, we need 30 more people. As you can see, we will gain in
two ways. These staff will position us to detect and respond more effectively to a
bioterrorism incident. In addition, their ongoing responsibilities will improve our
overall effectiveness as a public safety agency.
On a per capita basis, Kansas Citys need for 30 additional public health per-
sonnel to prepare for bioterrorism and for other public health emergencies trans-
lates nationally to about 15,000 more people working at the local level. The cost of
adding such personnel, who are the backbone of surveillance and emergency re-
84
sponse systems, does not include the costs of additional training, enhanced labora-
tories, secure and reliable communication and data management systemsall the
components of public health emergency response that the public may take for grant-
ed, but that we know are not in place.
Mr. Chairman, I know that you share my sense of urgency and recognition that
we have before us a momentous challenge. We wish that it hadnt taken a catas-
trophe to call public attention to the fact that, just as we must keep our military
defenses strong, so must we also keep our public health defenses strong. Thank you
for our longstanding encouragement and support.
Senator HARKIN. Dr. Archer, thank you very much. I know Sen-
ator Specter is late for another appointment. I am going to turn to
him now.
Senator SPECTER. Thank you very much, Mr. Chairman. We are
working simultaneously on the Judiciary Committee down the hall.
We are working on the antiterrorism bills, but I want to join Sen-
ator Harkin in thanking all of you for coming.
You are devoted professionals. You have been standing in the
wings, and now you are on center stage, and this is a matter of tre-
mendous urgency, and we thank you for your professionalism and
for your testimony, and there is a great deal which has to be done.
It is very reassuring to this subcommittee and really to the entire
Congress that you professionals are here to help us out and give
us direction. I do have to excuse myself at this point in time, so
given the 5 minutes for my questioning, I would allocate it to Sen-
ator Harkin. Thank you all very much.
Thank you, Tom.
Senator HARKIN. Again, I would just join Senator Specter in ap-
preciating your past service in which you have all been leaders,
and I have read your testimonies and your backgrounds, and it is
true you are now going to be in the forefront of this effort nation-
ally, and as more than one of you have said in your statements,
while we are not totally prepared, we are not starting from scratch.
Someone said that, I forget who, and that is true, we are not start-
ing from scratch.
We do have a good infrastructure out there. We do have the net-
work. We have the Public Health Service, we have our epidemiolo-
gists, but there are gaps. A couple of you talked about the gaps.
I think we are in pretty good shape for addressing naturally occur-
ring types of biological outbreaks. Are we in reasonably good
shape? Correct me if I am wrong. I thought we were not in very
good shape if it is not naturally occurring, either biological or
chemical.
Dr. ARCHER. Many natural outbreaks happen over weeks or a
month, whereas this kind of an event, it is hours and days, so it
really ramps up your surge capacity. But with West Nile, which
was natural, it crippled or it stressed one of the strongest health
departments we have in the country, and so our public information
side is not adequate to handle these issues.
Senator HARKIN. Dr. Quinlisk.
Dr. QUINLISK. I would just like to add, if you are talking about
the small, food-borne outbreaks, something like that, I think we
are handling those. But any time you have an outbreak where
there is serious illness, with large numbers of people ill, unexpect-
edly occurring, basically right now in Iowa, the people who are sup-
posed to be handling this cannot do it. We start having to pull peo-
85
ple from other areas of the health department to assist in calling

people, doing interviews, whatever, which then takes them away
from the other things, such as vaccinating children.
So I would say small things, maybe yes, we have the capacity,
but once you get beyond a small number, no, we really do not have
that capacity, and systems that support that capacity, such as lab-
oratory reporting, the coordination with the health care agencies,
data analysis, that is woefully inadequate at this point.
Senator HARKIN. Now, Dr. Cantrill, I have talked about, read the
whole scenario of Operation Top Off, and obviously that sort of in-
dicates that we are not prepared to meet at least the nonnaturally
occurring. Do you want to address yourself to that?
Dr. CANTRILL. I think that is definitely true. Even now, as I men-
tioned, we have no surge capacity. People will wait in emergency
departments for hours, sometimes days for a bed to become avail-
able upstairs, which I think is bad medical care. Because of bed
availability in most metropolitan areas there are major problems
with getting patients beds in institutions in those cities, and so
then you add an additional stress on top of that.
Quite honestly, pretty quickly the wheels come off. You are doing
the best you can. We certainly would do the best we could do, but
I think it would be very, very difficult. I think we would really com-
promise care in many cases.
Dr. TUCKER. I just wanted to comment on the threat of naturally
emerging infections. The scenario that scares a lot of epidemiolo-
gists is the possible resurgence of an endemic influenza that is
highly virulent, such as what occurred in this country in 1918,
1919. We are overdue for another major epidemic of this type, and
our public health system is not prepared even for that contingency.
Senator HARKIN. Now, again, just thinking this whole thing
through as I have for sometime now, it seems that you have got
a problem first of all in initial recognition among primary care pro-
viders out there. You may have heard earlier, I said that a doctor
over the weekend in Iowa had said to me, we need training. He
wouldnt even know what to look for in these things. He has never
had any training in this area. It seems to me that is the first area.
Dr. CANTRILL. Senator, I think that may be a little less of an
issue in terms of knowing there is something bad going on, at least
from the emergency department point of view. When you in one 8-
hour period admit your second normally healthy adult individual
who has to be intubated to go to the intensive care unit, the light
should click on, and that is where we need to increase awareness
amongst medical personnel that something is bad, and we need to
train them to go ahead and call their State health department to
get them going. I think we will know, especially when people are
breaking down your doors to get into the ED because they are so
ill, you will know there is something bad going on. You will not
know what it is yet.
Senator HARKIN. Well, Operation Top Off indicated there was
some lag time.
Dr. CANTRILL. Nominally 12 hours.
Mr. HAUER. There is a lag time, Senator, and the problem we
have got is, with most of these types of agents our surveillance sys-
tems are not sensitive enough at this point in time to pick up the
86
early indications of an incident. We have to rely on our primary

care providers to recognize that, and the training at the local level
for our primary care providers has not been there.
It is evolving now, and HHS has been rolling it out, but as Sec-
retary Thompson said, we need to do more along these lines. The
training at the local level is a big issue, and not just the primary
care providers in emergency rooms, but nurse practitioners that
take care of rural areas, family practitioners, they have to be
trained as well.
Dr. QUINLISK. I was going to add that I think that a medical sys-
tem realizing something might be odd probably does occur, it does
occur quickly. One of the biggest problems I see is, since there is
no training for them regarding how to then take that information
they have and get it to the health department, there is an incred-
ible gap there.
We had whole busloads of ill children brought into the emergency
rooms, and not a single person ever even thought to contact the
health department. I do not think that ER doc did not realize
something was going on, but there was the disconnect between the
medical system and the public health system that desperately
needs to be addressed.
Dr. ARCHER. That is why I propose we need that liaison function
there in the hospital that is part of the health department that
keeps that on a day-to-day basis, because one-shot training will not
do it. You have to keep that relationship going.
Senator HARKIN. There has to be a system whereby those pri-
mary care providers who may not be an M.D., such as a nurse
practitioner, could report this quickly through some centralized
board, where you would recognize it.
Now, something has to be done immediately, and I do not know
that that kind of system is in place.
Mr. HAUER. In point of fact, in most county and State health de-
partments it is a 9-to-5 operation. Some of them do have on-call
folks, some do not.
When I worked for then-Governor Bayh in Indiana, and I was
out there for 7 years overseeing the public safety agencies, we had
an occasion to call the department of health, and we put a system
in place. But when the Governor first came into office there was
no system, and getting people on the weekends was impossible. We
could not find a public health professional on the weekends. There
was no on-call system. If they wanted to report, you called in Mon-
day morning to report.
Senator HARKIN. If you are a bioterrorist you would strike Friday
night.
Mr. HAUER. Absolutely right.
Senator HARKIN. And you would have the whole weekend.
Mr. HAUER. By Monday morning, particularly with anthrax, the
event would be so far along, that window of opportunity would be
so narrow that we would at that point not be treating people, be-
cause once you get through the first phase of anthrax, they are not
treatable.
Senator HARKIN. Dr. Quinlisk.
Dr. QUINLISK. I wanted to make the point too it is not just get-
ting information from the hospitals to the public health system, but
87
the public health system has to get information down to the hos-
pital level to alert them to look for specific things, or that things
might be happening. We talk about the Health Alert Network, and
it is true that CDC alerted everybody on September 11, but the
problem is, they came to me at the State health department in
Iowa.
Right now I have no easy way of getting information out to the
hospitals, or down even to our local public health departments. We
sent out an e-mail, but then we had to call everybody in our de-
partment to start making phone calls to tell people to go look at
their e-mail that they received.
Now, we were lucky that that happened on a week-day. If that
had happened on an evening or a weekend, I do not know that we
would have had any possibility other than just call everybody we
can by telephone to put them on alert that way. That would have
been 99 county health departments even if we had been able to get
a hold of somebody, and calling over 100 hospitals personally in
that kind of system just is not going to meet these needs.
Mr. HAUER. Senator, I think one important point is, part of this
is our fault in public health. We have never looked at this as a re-
sponsive or proactive type of approach. There has always been the
luxury of time. In public health emergencies in the past you did not
have to respond in 4, 6, 12 hours.
Most reporting, as I mentioned in my testimony, has been by
three-part cards that you mail in to the department of health, and
they get it, and sometime over the next 4 or 5 months it gets en-
tered into the computer, because it has been mostly for sexually
transmitted diseases or other types of diseases that are required to
be reported. That urgency has not been there in the public health
arena, and that is something we have to instill, and we are instill-
ing into the public health arena. It has not been there in the past.
Dr. ARCHER. We changed our reporting ordinance so that within
4 hours of the suspicion of any of these conditions you had to report
those kinds of things. You would not have a police or fire depart-
ment close at 5:00 and not be available until the next morning, or
over the weekend, and yet we allow that with our public health
agencies.
For years we have underfunded our public health positions at the
local level. Those individuals, then, if they did not want to do
shiftwork in a hospital, might take a lower paid position. Even if
we want to go 247 and go 12-on, 12-off during an emergency we
have people whos lives may not be easily adjusted to even do that,
because we have not thought in that way. We have got some major
overhauling that needs to be done.
Senator HARKIN. Let me, if I might, turn to another aspect of
this which you heard me talk about and others talk about today,
and that is the whole issue of food safety. Now, again, it seems to
me there are at least a couple of objectives of terrorists. One is to
kill people. Now, that is what we are talking about when you are
talking about anthrax and botulism and these virulent pathogens.
That is meant to kill people and strike terror. But there may be
another objective of striking terror into people and disrupting the
economic system of our country.
88
With the food distribution system we have in America today, an

animal could be slaughtered in Kansas, and it could be processed
and within 24 hours people in Portland, Oregon could be eating
some of that, people in Miami, Florida could be having some of
that, and people in New York City could be having some of that.
It just goes all over the country within a day, and we have seen
cases where we have had to track back to find out exactly where
the origin of some salmonella, for example, originated.
I mean, consider the scenario that might happen if someone were
to place within our food supply chain at a certain point certain
pathogens that might not kill you, but could really make you aw-
fully sick, and what would happen to the public confidence in our
food supply system if that were detected and we found that it was
a manmade cause that was injected at a certain point?
The scenario would be that people would become very terrified of
buying food, and where would they go to get the best food, and how
could they be reassured, and yet from my vantage point of being
both on the Agriculture Committee and on this subcommittee, we
really have not done much to address that, and I need your
thoughts and your suggestions on how we might, both prevent and
rapidly address this to reassure people that we have caught it, that
we have stopped it, and that they are assured that the food they
buy the next day is going to be safe.
Do I make myself clear on that? How do we do that? Can we set
up that system?
Dr. ARCHER. One problem is that we might not even know that
if the cases are spread out enough, because now frequently these
people are treated symptomatically without laboratory testing or
confirmation. It is probably something we need to change, that if
the physician feels or sees more than one case, that the companies
would pay for even the laboratory testing, because we miss most
food-borne illness. We do not even pick it up, so we have got that
piece also. If we picked up more, we could handle, I think, more
of these types of things.
Most of these pathogens, if you cook it adequately, if you do the
food preparation things that people used to get in home economics
and may not get any more, then it would help reduce that risk.
Mr. HAUER. Also, finding out this is an intentional type of an
event is very difficult in one of these outbreaks. If you remember
the 1984 incident in Oregon, with the Rajneesh, over 750 people
were impacted.
Senator HARKIN. That was salmonella.
Mr. HAUER. Right, and it was almost 2 years later that we found
out that it was not accidental. When the FBI was interrogating one
of the members, they found out that it was, in fact, intentional. Ac-
cidental outbreaks versus intentional outbreaks can be very dif-
ficult to discern in this kind of an environment.
Dr. QUINLISK. That is the public health function. Hopefully these
things could be investigated very quickly, and we could find out
those kinds of things much more quickly and then do whatever
kind of prevention measures necessary to then go back to the pub-
lic and say, we have taken care of this, and you can go buy your
food tomorrow and feel okay.
89
Dr. CANTRILL. Senator, one of my concerns is, if we start having

to report every case of diarrhea to the public health department,
that is a very onerous obligation. In medicine today we are just
overregulated, and this would be an additional regulation if every
time I have a case of diarrhea I have to fill out a form in three
parts, so we need to work on smoothing those things out.
And quite honestly, the HIPAA regulations are an issue here too,
in terms of patient confidentiality. I think we have not fully inves-
tigated those yet, but I think those may compromise some of our
abilities to look over from a global vision point of view and see pat-
terns of diseases. We can maybe look at the individual patterns,
but we cannot get to the patient because that information is pro-
tected, so there are some very complex issues here we have to ad-
dress.
Mr. HAUER. Senator, I understand Steves concern about report-
ing, but I think with the right data-mining systems in place, the
right surveillance systems, it can all be automated as we have done
in New York City, and you really take the load off the medical care
providers and just do it in an automated fashion.
There are some issues with hospitals. They are concerned about
sharing data with their local health departments or their local
emergency management agencies, and we ran into that. But when
they realize that we were going to shield patient IDs, or maintain
confidentiality, and that we were not looking at their morbidity and
mortality rates, which was a big concern and real sensitive issue,
and that we were really just trying to track the health status of
the city on a daily basis, we got a fair amount of cooperation.
Dr. TUCKER. Just in terms of threat assessment or probability of
bioterrorism, I think food contamination is probably the most likely
type of incident, because the technical challenges are quite limited.
The Rajneesh, for example, used a low tech approach. They just
took vials of salmonella and poured them on restaurant salad bars
in 10 restaurants in the town of The Dalles, Oregon. It did not re-
quire a sophisticated dissemination system that many people have
talked about.
So if, as you said, terrorists are just wanting to scare people and
kill a few and scare a lot more, this would be the easiest approach.
Dr. QUINLISK. I would just add something. The Dalles salmonella
and the shigella from the medical center in Texas, were both lab-
oratory organisms. They actually went into a laboratory that actu-
ally had the legal authority to have those organisms. So going back
to some of the security things that need to be done, we do need to
make sure that the people who have the right to have those orga-
nisms have them under some kind of a secure method so that
somebody else cannot get a hold of them.
Senator HARKIN. There is one last thing I just wanted to cover
with you before we adjourn, and we have gone on long enough, but
I keep hearing about surge capacity. I think I have a vague idea
of what you are talking about. It is about the influx of patients and
we do not have the room, or the places, or the emergency rooms
to take care of that. How do we address the surge capacity problem
that hospitals have?
Mr. HAUER. Quite frankly, I do not think we ought to put these
patients in the hospitals. I think initially a lot of them will go to
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hospitals, but as Steve has said, hospitals will be overcrowded. We

did some modeling in New York, and we believe that you can set
up alternate care facilities and depending on the nature of the
agent and the type of illness you shunt these people away from the
hospital, and then if they are really sick, you put them in the hos-
pital, or if the hospitals are overwhelmed, you set up alternative
facilities.
We identified a number of locations throughout New York where
we could put 5,000 or 10,000 people, like the Javits Convention
Center. The biggest problem you have is needing to have a surge
of medical personnel, because I have to assume that a certain per-
centage of the medical providers are victims themselves, and will
want to stay home with their families. So I might lose 10 to 15 per-
cent of the medical care providers that I already need, so I am
going to have to rely on State and Federal resources to come in and
provide the care.
Finding the facilities should be relatively easy, and if it is a pro-
longed type of an incident, as you would see with smallpox or an-
thrax, DOD also has the ability to come in and set up medical fa-
cilities as well, but I think this is a role that local government
should be providing, and they ought to be identifying these facili-
ties now.
Senator HARKIN. Get them identified now, and locate them now,
so that they are ready.
Mr. HAUER. Then you integrate Federal and State resources into
the local response, and that ought to be the hallmark of any re-
sponse. You take Federal assets and integrate them into the State
and local response to supplement what is going on at the State and
local level.
Dr. ARCHER. We have to look back at our history such as the
1918 flu pandemic. We certainly have more hospital beds now than
we did then. Our city charter allows me to in effect commandeer
hotels, and set those up as a place to be able to put patients. If
this is communicable, we do not have enough negative pressure
rooms in our hospitals to have these patients there anyway, and we
cannot afford to take our hospitals offline for other treatment pur-
poses.
We have talked about issues of using drive-through banks and
fast-food places to hand out medication to be able to keep people
from getting in the same air space even, as a way to reduce the
spread.
The other issue on surge capacity, though, is being able to do the
outbreak investigation. What I mean by that is, we talk about in
some cities whether can we get the second SWAT team there in 15
minutes. With this, we need to be able to interview, like, 100 pa-
tients at 10 different sites in less than an hour, get them entered
into a computer data base, merge that, do an analysis to see
whether they all were at this building, this sporting event, where
were they exposed, so we can prioritize where we do our prophy-
laxis so we know what we are dealing with. We do not have that
capacity, but we are working on it.
Dr. QUINLISK. I would just like to say, too, one of the things we
have learned from some of these terrorist attacks, specifically, the
Sarin in the Tokyo subway, is that the number of people who were
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actually killed by this and the number of people who were actually
injured were very, very low, as compared to the numbers of people
who showed up for emergency care because they were concerned,
the worried well. That is, I think, a very big issue we need to be
addressing, and not just at the hospital systems or the public
health systems, but with the media.
They have got to get the correct information out to people and
not to panic them, because we have seen instances where the
media has, unfortunately, played into peoples panic and created
more of a hysteria than maybe was necessary. So that is another
area that I think we need to have very good relationships with and
communications with to make sure that the proper information
gets out to the public, because that is who people are going to be
relying on to get their medical information at a time of crisis.
Senator HARKIN. That is an excellent point.
Dr. CANTRILL. One issue about the surge capacity, as Senator
Kennedy mentioned, hospitals continue to close, and I think that
heightens any potential surge capacity problem we might have.
We have had 5 hospitals close in Denver in the last 5 years. We
have fewer beds now than we had 15 years ago, and 112 times the
population. This is a major problem. I do not have the answer for
it, but I think it really does need to be looked at. We need to keep
every bed that we have now.
I think staffing certainly has become an issue as well. Even
though we may have alternative sites, we may not have enough
staff to deal with some of the very ill patients.
Senator HARKIN. Any final comments or suggestions, advice you
might have, before we adjourn?
Dr. CANTRILL. I would like to personally thank you for having
these hearings. Having been in this area for several years, I am
very encouraged now that there is a resurgence of interest in this
area, and I think it is marvelous.
Senator HARKIN. The one thing that I hope comes out of it, and
I am sure that will come out of it, is a renewed interest in our Pub-
lic Health Service, and public health in general. It has been sort
of relegated to the back porch for a long time, and I think now we
should recognize we are all in this thing together. We need strong-
er support for all of our public health systems out there in very
many ways.
So hopefully this will at least boost that recognition, and get the
necessary funds out there to help on the local, State, and Federal
level to coordinate this. Public health, as someone said earlier, is
a national security issue, it really is, and now I think we are seeing
recognition of that.
So again, I thank you, as Senator Specter did, for your public
service and for your help in this area. As we move ahead in devel-
oping different responses and funding programs, please feel free to
give us your input either by phone or by e-mail, or whatever. If you
see us doing things you think we should not be doing, or we need
to boost something else, please, you are the experts, and we rely
on you, so please give us your best input as we move forward.
92
SUBCOMMITTEE RECESS
Thank you all very much for being here, that concludes our hear-
ing.
[Whereupon, at 1:40 p.m., Wednesday, October 3, the sub-
committee was recessed, to reconvene subject to the call of the
Chair.]
BIOTERRORISM
TUESDAY, OCTOBER 23, 2001
U.S. SENATE,
Washington, DC.
The subcommittee met at 11 a.m., in room S5, the Capitol, Hon.
Tom Harkin (chairman) presiding.
Present: Senators Harkin, Reid, Murray, Landrieu, Specter,
Hutchison, and Craig.
Senator HARKIN. The Subcommittee on Labor, Health and

Human Services, and Education Appropriations Committee will
come to order. Among the duties we have on this subcommittee is
to provide the necessary funding for the protection of the public
health here in America. It is an important responsibility, and one
that has taken on even greater significance over the last month.
In combatting bioterrorism, we face one of the greatest public
health challenges of our lifetime. Meeting that challenge will re-
quire considerable resolve, know-how, and resources. Read that as
money.
This subcommittee is prepared to do its part and I hope that the
Department of Health & Human Services understands that it is
this subcommittee of the Appropriations Committee on the Senate
side that will decide how much and how that money is going to be
spent. I have a feeling that some people at the Department of
Health and Human Services do not understand that, and they had
better understand it, and they had better start working with us so
that we can get the right information and that we are able to de-
cide on an appropriate basis not only how much, but where that
money is to go.
Several weeks ago we heard from Secretary Thompson and other
experts about the extent of the threat of bioterrorism. I think we
all came away understanding that we need to view our public
health system as a front line of our national defense. Just as we
need an army of well-trained and well-equipped soldiers to defend
us overseas, we need a well-trained and well-equipped public
health force to defend against bioterrorism. While we have made
some improvements, today I state emphatically we are in no way
as well-prepared to fight bioterrorism here at home as we are to
defeat enemies overseas. To use military terms, our troop force is
inadequate and ill-trained, our radar and communications systems
(93)
94
are outdated, we are short on ammunition, and our weapons sys-

tems need updating.
Well, we want to change that. Over the last several weeks, Sen-
ator Specter and I have consulted with experts, our colleagues, and
the administration to try to develop a comprehensive
antibioterrorism plan to include in the emergency supplemental ap-
propriations bill. We have put forward a $2.3 billion proposal that
both Senator Specter and I have worked on.
Now, the administration says that they think $1.5 billion is
enough. We think that is insufficient, and we need them to get
back to the pencils and sharpen them a little bit.
Now, in terms of medicine supplies and equipment, we believe
we need $643.6 million to acquire medicine, supplies, and equip-
ment for the National Pharmaceutical Stockpile. This would enable
us to treat an additional 10 million Americans exposed to anthrax
and other bacterial infections, and others exposed to possible chem-
ical weapons. We believe we need $509 million to acquire and
stockpile enough doses of the smallpox vaccine, and we will hear
about that this morning, to inoculate every American should that
ever become necessary.
We feel we need at least $700 million to beef up our State and
local public health capabilities and hospital surge capacity. This
would include training of doctors, nurses, and other health profes-
sionals, expanding the Health Alert Network, improving their ca-
pacity for early detection and surveillance, and increasing the ca-
pacity and security of public health laboratories.
We believe we need $140 million to expand the capacity of CDC,
including their labs, and assigning every State trained disease in-
vestigators to be on duty 24 hours a day, 7 days a week.
We need $10 million to establish a comprehensive data base and
tracking system for all biohazardous pathogens. We have this for
nuclear material. We should have it for biological agents. I know
this is difficult, and there may be some problems involved, but I
think we have to tackle it.
We feel we need $250 million to double our commitment to the
inspection of imported foods. Only about 1 percent of those foods
are currently being inspected. The administration only asks for $75
million. We believe we need $250 million.
So todays hearing will enable us to get input on this plan. We
will try to get answers on a number of questions, like how quickly
we can acquire this stockpile of vaccines we need, what steps are
most urgent to take, what resources are required, what is the most
effective course of treatment for those exposed to anthrax and other
biological pathogens, and what about electronic pasteurization, and
I will speak more about this with Dr. Koplan and others.
Can electronic pasteurization, which is approved by the FDA for
food safety processes, be used to make our mail safe and, if so, how
rapidly can we get it involved in some of our mail processing cen-
ters?
What can be done better, and I am glad the FBI is here today,
to coordinate public health and law enforcement resources? From
what I have seen, there has been some disconnect there and I
think we need to reassure ourselves that there is a good working
relationship between law enforcement and our epidemiologists.
95
We have a very distinguished panel of witnesses. I look forward

to hearing from each of them. I want to just conclude with this.
This is not the time to panic. We do not need to push any panic
buttons. That is what the bioterrorists want. But it is the time for
us to meet the requirements necessary to protect the American peo-
ple and to make sure we do it in the most expeditious, efficacious
manner possible.
There is a lot of misinformation out there. Misinformation can
lead to panic and unbased fears, but I believe we need better co-
ordination, we need better information, and I will be asking the
FBI about that. Where do you cross the line? They are doing inves-
tigations, and a lot of it they need to keep secret, I understand
that. But the public needs information. Our public health agencies
need information on which to make decisions to protect the Amer-
ican public. That is what we are talking about, not a panic, but we
need to determine a course of action and we need to start on it
now.
Now, with that, I would recognize my distinguished colleague,
Senator Specter.
Senator SPECTER. Thank you, Mr. Chairman, and thank you and
the staff for convening this very important hearing under very dif-
ficult circumstances. Those who may be watching this on CSPAN
do not know that we are in the tombs of the Capitol, not in our
customary hearing room in the Dirksen Senate Office Building, be-
cause that building is closed. The Hart Senate Office Building and
the Russell Senate Office Building are also closed. But we have
pushed hard to convene this hearing today because of the impor-
tance of this subject.
The terror of September 11 has resulted in a war on the terror-
ists now being waged in Afghanistan, but the public concerns and
the focal point of attention of America today is on bioterrorism, and
that is the subject we are going to address. We have very distin-
guished witnesses. We have the Director of the Center for Disease
Control, a key official from the FBI on counterterrorism, represent-
atives of the scientific and commercial community to deal with this
subject, and we do so because of the need for the inquiry to deter-
mine just precisely what appropriations need to be made.
The Congress responded immediately on the Friday after the at-
tack by appropriating $40 billion. A portion of that funding is going
to be directed to bioterrorism, and we are a rich and powerful and
ingenious country, and we can meet the challenge, but we have to
do so in a way which is totally realistic.
This subcommittee heard from Secretary of Health and Human
Services Thompson a couple of weeks ago and had assurances
which Senator Byrd, who is the chairman of the full committee,
categorized in very blunt terms, waving his arms for the evening
news and saying, I do not believe you. We need to be realistic as
to what our problems are and where we are going and assure the
American people that the Congress is functioning and that we do
have a plan and that we are prepared to do what is necessary.
This subcommittee, and Senator Harkin and I have worked hand
in glove as partners for more than a decade. He is now the chair-
96
man. We had a little reorganizational event in May, but it has not

made any difference. When I was the chairman for 612 years and
Senator Harkin was ranking and we were reversed we formed a
seamless operation. He and I learned a long time ago if you want
to get something done in Washington you have to cross party lines,
and we have been attentive to this issue, and that was before Sep-
tember 11.
I made a visit to the Centers for Disease Control a year-and-a-
half ago to respond to what I heard were the deplorable conditions
there, but they were not as deplorable as I had heard. They were
worse, and more than a year ago this subcommittee took the lead
in putting up $175 million to improve the infrastructure for the
Centers for Disease Control. Before September 11 we put up some
$250 million in fiscal year 2002 to continue those improvements at
the Centers for Disease Control. The warnings were clear as to
what was happening, but the reality is that no one knew the inten-
sity of the problem or could focus on it until the wake-up call came
on September 11, and now we are mobilized. Senator Harkin out-
lined our determination to put up the funds which are necessary.
I found that, being back in the State that there was a real need
for Senators and Members of the House of Representatives to com-
municate with their constituents. There has been a feeling for a
long time that if Government was not irrelevant, it was close to ir-
relevant. You get the Government out of the way and private enter-
prise will take care of things. Suddenly, Government has become
relevant, and shortly before this hearing was convened, the leaders
were talking about finishing up our business, which I think we
have to do by Thanksgiving, and making the decisions and putting
politics aside and returning to our States to take care of very im-
portant business and talking to our constituents.
We really should finish our business by September 30, and
Thanksgiving it seems to me is the outside date, so Senator Har-
kin, I thank you for pushing ahead today, and the staff. Late yes-
terday afternoon we did not think we would have a hearing. We
were shut out of the Russell Building, but we are here today and
we are prepared to go to work to solve this problem.
Senator HARKIN. Thank you very much, Senator Specter.
Our first panel will be Dr. Jeffrey Koplan, Director of the Cen-
ters for Diseases Control. Dr. Koplan has had a very distinguished
career. He was a member of the CDC team that helped eradicate
smallpox. He has served as Assistant Surgeon General and has
been involved in public health for most of his adult life. He has his
B.A. from Yale, his M.D. from Mount Sinai School of Medicine, and
a masters in public health from Harvard. Also on the first panel
is Mr. James Caruso, Deputy Assistant Director of the
Counterterrorism Division at the FBI. Before being appointed to
his current post, Mr. Caruso served as Special Agent in Charge of
the National Security Division in Washington, and also served on
the investigation staff of the U.S. House of Representatives Com-
mittee on Appropriations.
Before I turn to you, Dr. Koplan, you know I have the greatest
respect for you personally and professionally. I have the highest re-
spect for the FBI and for the Centers for Disease Control and Pre-
97
vention, with whom I have worked closely for the past 15 years. I
must tell you I have some deep concerns, and I might as well get
it off my chest right now, about the actions of the CDC recently in-
volving the events surrounding the deaths of the two postal work-
ers here in Washington. This is where I hope to get some informa-
tion from both of you about what is happening in terms of coordi-
nation.
Now, I am not one that believes the headlines all the time, but
it says here in The Washington Post: Workers Question Response;
CDC Says Policy Evolving. Officials at the U.S. Center for Disease
Control acknowledged yesterday that recommendations for postal
workers are still evolving. It says in the paper this morning: We
are dealing with something that up until 2 or 3 weeks ago we had
not dealt with before, said CDC spokesman Tom Skinner.
Well, that is what CDC is for. Of course there are things we have
not been up against before, but we would hope that CDC would
have had some kind of a plan that they could have used to trace
back, to use the epidemiologists to ensure that we would trace ev-
erything back and make sure that everything was covered.
Here is another quote from the story: What we do is still sort
of a work in progress. We are making decisions based on the best
scientific information we have at the time.
Based on that record, and on the absence of evidence of contami-
nation inside the Brentwood building, CDC officials advised the
U.S. Postal Service the workers there did not need to take anti-
biotics. They reversed that advice on Sunday, when the first Brent-
wood employee was diagnosed with the inhaled form of anthrax.
Well, first of all, we get the letter that comes into Senator
Daschles office. Hundreds and hundreds of people here in the Cap-
itol were tested. We knew at that time, or shortly thereafter, that
a couple of officials in Trenton, New Jersey had come down with
the skin form of anthrax. Trenton, New Jersey to here, someone
here gets it, at least they tested positive, and we know that the
powder substance was anthrax. We have officials in Trenton, New
Jersey at the postal facility that come down with the skin form of
anthrax. In between, it goes through Brentwood, and yet the people
at Brentwood are told do not worry about it. At least, that is my
reading, and I am very concerned, Dr. Koplan, about what CDC is
doing, and how they are operating to make sure that those who
have any possible connection with this in any of these facilities are
alerted, that they are tested, and that they are treated in a timely
fashion.
Now, I do not know, maybe I am wrong, but it just seems to me
something broke down here, or is broken down. I do not know
whether it is the FBI in terms of trying to find out who is doing
this, and trying to trace it back, and needing some secrecy. I do not
know if that is a part of the problem. If it is, we have got to get
over it, because obviously, people are getting sick and people are
dying, and we cannot afford to continue to have this happen.
So whatever happened at Brentwood we just cannot afford to let
happen anywhere else. We count on CDC. You are our line of de-
fense at CDC to set out the procedures, the processes, the steps we
take to make sure that our people are protected, and quite frankly,
as you can tell by my tone of voice, I am a little upset about this,
98
because I felt all along that CDC really was on top of this. Maybe
they still are, and maybe you can reassure us this morning that
they are.
Dr. KOPLAN. I hope to.
Senator HARKIN. I appreciate that. Thank you very much, Dr.
Koplan, and I would turn it over to you for an opening statement.
STATEMENT OF JEFFREY P. KOPLAN, M.D., M.P.H., DIRECTOR, CEN-
TERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Dr. KOPLAN. Thank you, Mr. Chairman, and Senator Specter, I
will address in detail the issues you have raised and try to reas-
sure you and every one here and the public that the expectations
they have of us have been met and are being met and will be met
in this outbreak, and provide you with an explanation and some
understanding of the issues you have just described.
Thank you for the invitation to update you on CDCs public
health response to the threat of bioterrorism. All of our vigilance,
preparedness, and understanding shifted after September 11, but
prior to that, this committee under both of your leaderships has
recognized the importance of bioterrorism, and has provided us
support for many key programs in this regard, but the public
health system of the United States is severely challenged at the
moment.
At CDC we have reorganized ourselves. We have reassigned
staff, deployed over 200 people to the field investigations at several
sites, we have laboratory epidemiologists and other public health
professionals working 24 hours a day. At State and local levels
similar efforts are being undertaken, but the system is stressed
through years of neglect and underinvestment. Labs are inundated
with specimens. Epidemiologic investigative staff, where present,
are being run ragged. Communications capabilities are strained,
and cash-strapped States and localities face extraordinary
unbudgeted costs for overtime, reagents for tests, extra equipment,
et cetera.
Despite this stress, one can see how public health works in a cri-
sis, and the unseen system which has been taken for granted and
now expected to perform has performed admirably, from the initial
disaster in New York and the response to the New York City
Health Department to a wide variety of health problems there, in
trying to anticipate other health problems. We have worked with
them from September 11 afternoon on, and still have many dozen
staff there working on everything from bioterrorism issues to envi-
ronmental health issues, in Florida and in New York and Wash-
ington, D.C. similarly.
If you like, I could now expand on the situation in Washington
that you have just targeted and explain a little bit, but if you will
permit me, let me back up a little bit to some of the other inves-
tigations, because these are stepwise pieces of information that we
acquired.
Yes, we are amongst the most knowledgeable places in the world
in epidemiologic investigation and in the problems of anthrax as
well, but sometimes the information we have on day 14, which
would have been very valuable on day 10, cannot be used on day
10 when you do not get it until day 14, and while we do try to an-
99
ticipate things like this, there is a stepwise process of building in-

formation that derives both an epidemic investigation and permits
us to take the appropriate steps to control it. Let me back up a lit-
tle bit and talk about some of these pieces.
In the initial investigation in Floridayou have heard a lot
about what state the U.S. public health system is in. Here is a case
where an astute clinician could have easily passed over an ill pa-
tient and said, I just do not know what this is, and we will ascribe
it to a pneumonia or a meningitis of unknown cause, but instead
this individual sent specimens, took collected specimens, sent them
to a lab specifically to test for anthrax, which he had never seen
before, had not been present in the State of Florida for years, but
because of this increased sensitivity, because of educational courses
provided for infectious disease specialists on potential bioterrorist
agents his antennae were up. He got an initial positive.
It was then sent to the Florida State lab. Through support that
you all have provided to us, that Florida State lab had had recent
training on the diagnosis of anthrax at CDC and had the reagents
to do it, and they did that testing and got an initial positive.
At that point, they needed confirmation from another backup fa-
cility and called us. They called us on a Wednesday night, late, de-
scribed the situation to us, described the results, wanted to send
a specimen, got it on a plane that night, we received it on Thurs-
day morning in Atlanta, and had confirmed the diagnosis by noon.
Prior to that, not even waiting for that diagnosis, we, in consulta-
tion with the Florida State Health Department, had put together
an investigative team, had them on a plane and on their way, prior
to the confirmation being received, and that investigation went into
play.
Yes, we know something about anthrax, but I would have you
keep in mind that in the course of our 50-plus years of history
there have been 200 cases of anthrax in this country as a whole,
all of them associated with people who deal with hides, animals,
wool-sorting, et cetera, so we have a body of experienced based on
that, and like everyone else in the world, most of the rest of our
experience is on reading things, studying things, doing things in
the laboratory, but we are all thankful we have not had to have
the experience with a bioterrorist event, per se, before.
In the case in Florida and then in our subsequent information in
New York, we began to piece together what placed people at risk
in these circumstances and in Florida, as you know, there have
been only two cases, and very unfortunately one of the gentlemen
died from inhalation anthrax, another person is still hospitalized
and stable with it, but it was related to either opening mail or
being in a closed space where mail was opened, and again from
past knowledge, from reading about others experiences with an-
thrax, one has to base ones approach from the information avail-
able and towards what we learn on a day-to-day basis from the lab
and, as you say, epidemiologic investigations.
So as we pursued things in Florida, we looked for all different
kinds of spread and other modes of transmission, and we backed
up through the system. We go upstream from where the cases are,
and continue to look, is there exposure, are there caseswe reach
100
a wider community. Are there cases that we are missing of this

that would give us more information?
In this instance, there continued to be the linkage between an
opened letter, and its a physical property, a physical substance
that this anthrax is present in a powdered form and needs to get
out in order to expose people.
Following that, we had experience working closely with our New
York City Health Department colleagues on cases in New York,
again, where we and our colleagues at FBI are open as to how is
this being spread? You cannot assume the same cause each time,
but here was again a place where the letters were received, where
an incriminating letter this time was found, and that is the dif-
ference between New York and Florida. Each one of these is a little
different.
In Florida, we did not have a letter in our hand. We knew the
people worked with mail, and suspected that is what had hap-
pened, and they remembered having mail that was suspect that
had come through, but we did not have that letter in our hand that
we could look at and test to see what the powder was, to see how
it might have been transmitted, to see what its properties were.
In New York, there was such a letter, which in turn confirmed
this association with mail from Florida, and in turn, in New York,
the association with the letter and opening it involved a second
form of anthrax, a less severe form called cutaneous anthrax on the
skin, and there was no evidence of inhalation disease there.
We are puzzled. Why was there inhalation disease in Florida at-
tached to the letter there, but there was no explanation. There was
no one present when the individual involved had opened it. He
opened it in a way that caused the dust to come out. Was there
more dust in that letterand we do not have the letter, so we can-
not tell whether it was ragged or whether it was leaking, or wheth-
er it had other properties attached to it.
So that we end up at this point with two cases of inhalation an-
thrax associated with opened mail, and all of our cases in New
York associated with either a given open letter, or places where
mail gets opened, desk tops, people whose job it is to open the mail,
not just to handle the mail but to open the mail.
So one of our questions throughout this has been, how far back
up the mail chain do you go? It can go to every household in the
country eventually, at an extreme, or it can go to every post office
in the country, or what we try to do is go backwards from the cases
that we found and see, is there evidence of anthrax present in
these places, is there evidence of illness in these other places, to
go backstream to it.
Here in Washington, we have been involved with a number of
other partners. In both Florida and New York and in New Jersey
our primary linkage is with State and local health officials and
with the FBI who do the criminal investigations out of this. In
Washington, there have been a number of folks involved in this,
where it started at the Hart Office Building, and again, let me re-
assure you and say, absolutely that we used the same standards,
we used the same approach, and we tried to be as diligent, as
quick, and as thorough no matter where or to whom these cases ap-
pear, or where the threat is.
101
We work in public health. There is no favoritism. In fact, it is

quite the reverse. We are most interested in folks who are less fa-
mous, less well-off, and less visible, throughout the field of public
health, so our approach has been to take a systematic, rational ap-
proach to dealing with this, because it is natural in epidemics, and
we have experience in thousands of epidemics, for people to want
to rush to make a decision early, and it may be the wrong one and
can cause more harm and illness than not.
Let me also add the antibiotics in this are not without harm
themselves. We have no desire to withhold antibiotics, nor does
anyone in the health field, from people who need it. Our key goal
is to identify who needs it, and let us make sure they get it, and
not have people take it unnecessarily, because there is a risk.
We have already had some significant and serious adverse reac-
tions from people taking these, including some of our own staff tak-
ing these antibiotics, so we want people on them who need them,
and we do not want people to take them unnecessarily, so there is
a balance in there. Where we have to err, we want to err on the
side of more people taking antibiotics to better cover them for this
serious disease.
In the case of the Hart Building, the investigation again, just as
you indicated, Senator Harkin, we tried to target it by epidemio-
logic grounds. In other words, just not distribute samples and dis-
tribute environmental swabs all over the place, but target where
there is a problem. Again there is a letter, and it is a letter on
someones desk, and we are able to go find a potential source of ex-
posure in this instance. The letter was opened, and again the peo-
ple right around it were the ones at greatest risk, and our experi-
ence in New York, when we did both environmental specimens
from people and from surfaces, the spread was pretty much con-
fined If we opened a letter here, it would be in this space around
here, with very little going beyond it, so that was our approach in
the Hart Building as well.
Many people came who wanted both swabs and who wanted anti-
biotics, and our policy wherever we have been is not to discourage
anyone who wants it from getting it, and so many staff came who
we did not feel were likely to be exposed, but ours is not to say you
cannot have it or you should not get it. Instead we say, and we
have said it in every instance, including the Postal Service, take it,
take it for x number of days. It comes to in some cases 10 days,
in some cases 14, in some cases fewer, and we will come back to
you then and determine what your risk is. You may have to take
it for 60. We may be able to say to you, your risk is really neg-
ligible, you do not have to keep taking it.
And I think that is what we have seen at the Hart Office Build-
ing, where the environmental isolation was targeted, not just in the
suites immediately around Senator Daschles office, but on the fifth
and sixth floor, and a mailroom in Dirksen, so we used the environ-
mental specimens to correlate our previous observations, and that
makes a rational approach in this, where lots of people do not have
to be on the antibiotics unnecessarily, with potential risk to them,
yet the people who need it are taking it.
In the issue with the mail sorting facility, as we had had no
cases of inhalation anthrax in a mail-sorting facility, and there was
102
no reason to think, based on everything we had seen so far, that

this was a possibility, because open mail had been the relationship
between these cases and mail was not being opened in these facili-
ties, as soon as the first inhalation case became known, we imme-
diately, working withand we are part of the larger team in this.
There is the D.C. Health Department, there is the Postal Service
itself, and let me just say to you that my very first conversation
with the Postmaster General, as soon as this started his word to
us was, he will do whatever is necessary to protect the health of
his workers. That is number 1, and that no modification has to
take place for any other of their responsibilities. Nothing super-
sedes the health of his workers, and he has had that attitude at
every discussion we have had together.
On inspecting that place, we could not be sure what letters had
gone through there.
Senator HARKIN. What place, Brentwood?
Dr. KOPLAN. I am sorry, the Brentwood facility. On getting there,
what was troublesome was that obviously mail is not opened there,
so that the hypothesis we were working on all along, that you had
to have an open letter to spread this, whichand I hope you will
agree with me is somewhat reasonable. Most things that are in let-
ters are in that letter, and our past experience in other places was
that only when it was opened did the person get inhalation an-
thrax, and even in some cases where it was opened, it was still cu-
taneous, and we had not seen inhalation anthrax in places where
the mail was not opened, so this was the first case, with that very
first case, which was new information, and very different from
what we had been seeing.
We immediatelyin consultation with the Postal Service, the
station was closed by them. Specimens were taken from all over.
All of the staff was offered antibiotics, and that was supplied. We
had the material here in town, and got it to them to take. Everyone
was told to take it. The people in the immediate area around the
facility where the first case occurred were urged and told that they
were going to need to take it for 60 days, even then. Everyone else
was told, here is 10 days, and we will determine further needs
then.
Senator HARKIN. Do you remember what day that was, Doctor?
Dr. KOPLAN. I am afraid all of these days are flowing together.
It was, I believe, Sunday or Monday morning.
Senator HARKIN. Like, yesterday?
Dr. KOPLAN. Exactly.
Senator HARKIN. After the two people had already expired?
Dr. KOPLAN. The two people that expired were notyes, that
may have happened after the two people had expired, but those
two people who expired had not been identified earlier either to us
or had come through the system. You can only act on the informa-
tion you have got in hand.
We were not passively collecting information. One of the things
we do in Florida and New York and Washington, DC is we had ac-
tive surveillance going on in hospitals throughout Metro DC, in-
cluding Virginia and Maryland, looking for other ill people who
might even possibly have inhalation anthrax, and these two did not
turn up. I think in one of themand these are terrible cir-
103
cumstances for the individuals and their families, and again let me
assure you, we are health professionals. Our job is for people not
to get ill or to die, so these are tragedies for us as well, and not
something that we take lightly in the least, but you have got to
know about the cases as well in order to take action on them, and
one of these individuals had been seen, had relatively mild symp-
toms, and was not associated with the outbreak in any way, or the
Brentwood mail facility, and progressed very rapidly, extremely
rapidly, and died before the medical staff could do much at that
point.
So that yes, these two cases came in, but already action had been
taken. The action, the decision to both close the facility and to get
people on treatment did not await these two cases. My under-
standing from discussion with colleagues up here was that that de-
cision was made immediately after that first case. It did not await
these two deaths.
Senator HARKIN. Do you mean the decision was made to put ev-
eryone on antibiotics?
Dr. KOPLAN. Put everyone on antibiotics and begin to take speci-
mens, close the facility to take environmental specimens to see how
far the anthrax had spread.
Let me reiterate. Knowing what we know today, would we have
done things differently 3 days ago, or 4 days ago, yes. Let me add
that that is true in every epidemic I have ever investigated. We al-
ways learn things, because we are out looking for things a day
after or 2 days after that could have helped us 2 or 3 days before,
but the absence of this investigative approach, the absence of doing
this at all can mean a much more serious and longstanding epi-
demic.
We do not want any cases, and we do not want any deaths, but
we do not always get the information necessary to permit us to op-
erate that way.
Senator HARKIN. I hate to interrupt you, but you had the Tren-
ton facility, and you had the postal workers there that had cuta-
neous anthrax. Now, was that because of open mail, that they
opened something in that facility, or what?
Dr. KOPLAN. There seemingly was a heavier level of contamina-
tion related to the Trenton area.
Senator HARKIN. But you do not know if it was open mail or un-
opened mail?
Dr. KOPLAN. We do not know, nor do we know whether it was
packages or what it was. We only know that the postmark on a
couple of these letters did come through Trenton, and we had a let-
ter from NBC in New York that had a Trenton postmark on it, and
then I believe Senator Daschles had a Trenton postmark.
Senator HARKIN. So when did you first test the Brentwood facil-
ity?
Dr. KOPLAN. I believe Friday night was the first time we got into
the Brentwood facility. I do not have a chronology in front of me
to go over this with you, but we could certainly provide that.
Senator HARKIN. Would you provide a chronological order of that,
because I want to know how soon it was after the workers in Tren-
ton were diagnosed, how soon after that did you start to test or
104
start to at least inform the employees at the Brentwood facility. I

would ask for that chronology.
Dr. KOPLAN. Sure.
Senator HARKIN. But the point is, we do not know whether the
contamination at Trenton was from open mail or not. We just sim-
ply do not know that.
Dr. KOPLAN. I think that is being investigated now. There are
several cases there. They perform different tasks, and we are
checking as to what they might have been exposed to and what
they did and what they saw. I think the supposition that it has to
be open mail is clearly not a sole supposition now.
Clearly, that puts people more at risk, but what is very dis-
turbing about this to all of us is that apparently closed envelopes
can potentially transmit as well. We do not know whether that is
out of open flaps in the envelopes, whether it potentially can pass
through the envelope, we do not know. Lots of this would be easier
if we had answers to all of these things. Some of them we learn
as we go along, and some we may not know for sometime, but we
have investigated thousands of outbreaks over 50 years, and have
a pretty good track record. I have investigated dozens myself.
PREPARED STATEMENT
The difference is, this one isas you are all well aware, is not
a naturally occurring event, and we have experience with how
things pattern themselves in a naturally occurring event, but here
we have an ongoing malevolent force working against us and pos-
sibly a force with some level of sophistication, so I can assure you
we are working hard, we are working fast, and absolutely working
equitably in every single place. We do thiswhether we can get the
answers as fast as we would all like to have them, probably that
will not be the case, because we would like to have those answers
yesterday, but I do not think you would find a better place, or an
institution, or a people to be doing this than the ones you have
doing this, whether it is in New York, Florida, New Jersey, or
Washington, D.C.
PREPARED STATEMENT OF DR. JEFFREY P. KOPLAN
Good morning, Mr. Chairman and Members of the Subcommittee. I am Dr. Jeffrey
P. Koplan, Director, Centers for Disease Control and Prevention (CDC). Thank you
for the invitation to update you on CDCs public health response to the threat of
bioterrorism. I will update you on CDCs response to recent anthrax exposures, and
I will discuss the status of implementing the overall goals of our bioterrorism pre-
paredness program.
As has been highlighted recently, increased vigilance and preparedness for unex-
plained illnesses and injuries are an essential part of the public health effort to pro-
tect the American people against bioterrorism. Prior to the September 11 attack on
the United States, CDC was making substantial progress toward defining, devel-
oping, and implementing a nationwide public health response network to increase
the capacity of public health officials at all levelsfederal, state, and localto pre-
pare for and respond to deliberate attacks on the health of our citizens. The events
of September 11 were a defining moment for all of us, and since then we have dra-
matically increased our levels of preparedness and are implementing plans to in-
crease it even further.
105
RECENT ANTHRAX EXPOSURES
As you are aware, many facilities in communities around the country have re-
ceived anthrax threat letters. Most were received as empty envelopes; some have
contained powdery substances. Moreover, in a few cases, actual anthrax exposures
have occurred. On Wednesday, October 3, the Florida Department of Health notified
CDC of a positive anthrax laboratory test result in a Florida resident who had re-
cently visited North Carolina. Samples were sent overnight to CDC for confirmatory
testing, and CDC dispatched two investigative teamsto Florida and North Caro-
linathe next day. By Sunday, October 7, test results confirmed that a second per-
sona coworker of the first individualhad been exposed to anthrax and that
traces of the bacteria had been found in the workplace. A decision was made to close
the building, and additional CDC staff were sent to help manage notification, health
evaluations of other coworkers, and provision of prophylactic antibiotics after the
National Pharmaceutical Stockpile was deployed.
As CDC was continuing to receive clinical specimens and environmental samples
from Florida, we became aware of a possible case of cutaneous anthrax in New York
City. This person, an NBC employee in Rockefeller Plaza, had received an envelope
containing powder on September 25. The diagnosis was confirmed by im-
munohistochemistry on a skin biopsy specimen in CDCs laboratory in the early
morning of October 12, and the New York City Health Department and CDC imme-
diately implemented appropriate public health actions, including restricting activity
on two floors of 30 Rockefeller Plaza and evaluating workers for the need for pro-
phylactic therapy. CDC sent additional investigative personnel to New York, joining
the more than 30 epidemiologists and other CDC stall assisting with worker injury
and enhanced syndrome surveillance following the September 11 terrorist attack.
Laboratory studies on the powder from the September 25 letter were negative for
the organism causing anthrax. Subsequent investigation identified a second letter
that arrived on September 18, which was found to be contaminated with Bacillus
anthracis, the organism that causes anthrax.
Last week, on October 15, CDC was notified of a possible anthrax exposure on
Capitol Hill. A letter, which has now been confirmed to have contained B. anthracis,
was opened by a Senate staff member. This person took appropriate action, noti-
fying emergency personnel, and Capitol, local, and federal emergency workers imme-
diately implemented public health measures. Certain areas of the office building
were closed, and employees were screened by history for exposure and started on
antibiotic prophylaxis after a nasal swab was obtained for epidemiologic purposes.
CDC sent two teams of epidemiologists to assist local, state, and federal authorities
in the investigation.
The best defense against such biologic threats continues to be accurate informa-
tion regarding how to recognize a potential threat and knowledge of appropriate ac-
tions. In the Morbidity and Mortality Weekly Report (MMWR) and in multiple
health advisories distributed via the Health Alert Network, CDC has issued several
updates on the investigations as well as interim guidelines for state health depart-
ments with recommended procedures for handling such incidents. These guidelines
include advice to the public and state and local health officials dealing with sus-
picious incidents, as well as guidance to clinical laboratory personnel in recognizing
Bacillus anthracis in a clinical specimen. The guidelines also outline post-exposure
prophylaxis recommendations. In persons exposed to Bacillus anthracis, disease can
be prevented with antibiotic treatment. Early antibiotic treatment of all forms of an-
thrax is essential. Bacillus anthracis usually is susceptible to penicillin, doxycycline,
and fluoroquinolones; but for bioterrorism planning, ciprofloxacin or doxycycline is
recommended as the antibiotic for initial use for prophylaxis. Copies of the October
19, 2001, MMWR, which addresses these issues, have been provided to the Sub-
committee.
In collaboration with state and local health and law enforcement officials, CDC
and the FBI are continuing to conduct investigations related to anthrax exposures.
During this heightened surveillance, cases of illness that may reasonably resemble
symptoms of anthrax will be thoroughly reviewed until anthrax can be ruled out.
The public health and medical communities continue to be on a heightened level of
disease monitoring to ensure that any potential exposure is recognized and that ap-
propriate medical evaluations are given. This is an example of the disease moni-
toring system in action, and that system is working.
As of noon October 22, 2 cases of inhalational anthrax have been identified in
Florida, 2 cases of inhalational anthrax have been identified in Washington, DC, 5
cases of cutaneous anthrax have been identified in New York City, and 3 cases of
cutaneous anthrax have been identified in New Jersey.
106
PUBLIC HEALTH LEADERSHIP
The Department of Health and Human Services (DHHS) anti-bioterrorism efforts

are focused on improving the nations public health surveillance network to quickly
detect and identify the biological agent that has been released; strengthening the
capacities for medical response, especially at the local level; expanding the stockpile
of pharmaceuticals for use if needed; expanding research on disease agents that
might be released, rapid methods for identifying biological agents, and improved
treatments and vaccines; and preventing bioterrorism by regulation of the shipment
of hazardous biological agents or toxins.
As the nations disease prevention and control agency, it is CDCs responsibility
on behalf of DHHS to provide national leadership in the public health and medical
communities in a concerted effort to detect, diagnose, respond to, and prevent ill-
nesses, including those that occur as a result of a deliberate release of biological
agents. This task is an integral part of CDCs overall mission to monitor and protect
the health of the U.S. population.
In 1998, CDC issued Preventing Emerging Infectious Diseases: A Strategy for the
21st Century, which describes CDCs plan for combating todays emerging diseases
and preventing those of tomorrow. It focuses on four goals, each of which has direct
relevance to preparedness for bioterrorism: Disease surveillance and outbreak re-
sponse; applied research to identify risk factors for disease and to develop diagnostic
tests, drugs, vaccines, and surveillance tools; infrastructure and training; and dis-
ease prevention and control. This plan was developed with input from state and
local health departments, disease experts, and partner organizations such as the
American Society for Microbiology, the Association of Public Health Laboratories,
the Council of State and Territorial Epidemiologists, and the Infectious Disease So-
ciety of America. It emphasizes the need to be prepared for the unexpectedwheth-
er it is a naturally occurring influenza pandemic or the deliberate release of small-
pox by a terrorist. It is within the context of these overall goals that CDC has begun
to address preparing our nations public health infrastructure to respond to acts of
biological terrorism. Copies of this CDC plan have been provided previously to the
Subcommittee. In addition, CDC presented in March a report to the Senate entitled
Public Healths Infrastructure: A Status Report. Recommendations in this report
complement the strategies outlined for emerging infectious diseases and prepared-
ness and response to bioterrorism. These recommendations include training of the
public health workforce, strengthening of data and communications systems, and
improving the public health systems at the state and local level.
CDCS STRATEGIC PLAN FOR BIOTERRORISM
CDC outlined necessary steps for strengthening public health and healthcare ca-
pacity to protect the nation against bioterrorist threats in its April 21, 2001, MMWR
release of Biological and Chemical Terrorism: Strategic Plan for Preparedness and
ResponseRecommendations of the CDC Strategic Planning Workgroup. This report
reinforces the work CDC has been contributing to this effort since 1998 and lays
a framework from which to enhance public health infrastructure. In keeping with
the message of this report, five key focus areas have been identified which provide
the foundation for local, state, and federal planning efforts: Preparedness and Pre-
vention, Detection and Surveillance, Diagnosis and Characterization of Biological
and Chemical Agents, Response, and Communication. These areas capture the goals
of CDCs Bioterrorism Preparedness and Response Program for general bioterrorism
preparedness.
Preparedness and Prevention
CDC has been working to ensure that all levels of the public health community
federal, state, and localare prepared to work in coordination with the medical and
emergency response communities to address the public health consequences of bio-
logical and chemical terrorism.
CDC is creating diagnostic and epidemiological guidelines for state and local
health departments and will help states conduct drills and exercises to assess local
readiness for bioterrorism. In addition, CDC, the Food and Drug Administration
(FDA), the National Institutes of Health (NIH), the Department of Defense (DOD),
and other agencies are supporting and encouraging research to address scientific
issues related to bioterrorism. In some cases, new vaccines, antitoxins, or innovative
drug treatments need to be developed, manufactured, and/or stocked. Moreover, we
need to learn more about the pathogenesis and epidemiology of the infectious dis-
eases which do not affect the U.S. population currently. We have only limited knowl-
edge about how artificial methods of dispersion may affect the infection rate, range
of illness, and public health impact of these biological agents.
107
Detection and Surveillance
As was evidenced in Florida, New York, and Washington, DC, the initial detection
of a biological terrorist attack occurs at the local level. Therefore, it is essential to
educate and train members of the medical communityboth public and private
who may be the first to examine and treat the victims. It is also necessary to up-
grade the surveillance systems of state and local health departments, as well as
within healthcare facilities such as hospitals, which will be relied upon to spot un-
usual patterns of disease occurrence and to identify any additional cases of illness.
CDC is providing terrorism-related training to epidemiologists and laboratorians, in-
fection control personnel, emergency responders, emergency department personnel
and other front-line health-care providers, and health and safety personnel. CDC is
providing educational materials regarding potential bioterrorism agents to the med-
ical and public health communities on its website for Public Health Emergency Pre-
paredness and Response at www.bt.cdc.gov. CDC is working with partners such as
the Johns Hopkins Center for Civilian Biodefense Studies (www.hopkins-bio-
defense.org) and the Infectious Diseases Society of America to develop training and
educational materials for incorporation into medical and public health graduate and
postgraduate curricula. With public health partners, CDC is spearheading the devel-
opment of the National Electronic Disease Surveillance System, which will facilitate
automated, timely electronic capture of data from the healthcare system.
Diagnosis and Characterization of Biological and Chemical Agents
To ensure that prevention and treatment measures can be implemented quickly
in the event of a biological or chemical terrorist attack, rapid diagnosis is critical.
CDC has developed guidelines and quality assurance standards for the safe and se-
cure collection, storage, transport, and processing of biologic and environmental
samples. In collaboration with other federal and nonfederal partners, CDC is co-
sponsoring a series of training exercises for state public health laboratory personnel
on requirements for the safe use, containment, and transport of dangerous biological
agents and toxins. CDC, also in cooperation with the Association of Public Health
Laboratories (APHL) and the National Laboratory Training Network (NLTN) have
sponsored a hands-on laboratory course for public health microbiologists. In con-
junction with the course, CDC produced two videos that were distributed to the par-
ticipants as well as to members of the NLTN. The participants in this course are
now using these videos and the other materials developed by CDC to train other
laboratorians in their states. CDC is also enhancing its efforts to foster the safe de-
sign and operation of Biosafety Level 3 laboratories, which are required for handling
many highly dangerous pathogens. Furthermore, CDC is developing a Rapid Toxic
Screen to detect peoples exposure to 150 chemical agents using blood or urine sam-
ples.
Response
A decisive and timely response to a biological terrorist event involves a fully docu-
mented and well rehearsed plan of detection, epidemiologic investigation, and med-
ical treatment for affected persons, and the initiation of disease prevention meas-
ures to minimize illness, injury and death. CDC is addressing this by (1) assisting
state and local health agencies in developing their plans for investigating and re-
sponding to unusual events and unexplained illnesses, and (2) bolstering CDCs ca-
pacities within the overall federal bioterrorism response effort. CDC is formalizing
current draft plans for the notification and mobilization of personnel and laboratory
resources in response to a bioterrorism emergency, as well as overall strategies for
vaccination, and development and implementation of other potential outbreak con-
trol strategies such as quarantine measures. In addition, CDC is developing na-
tional standards to ensure that respirators used by first responders and by other
health care providers responding to terrorist acts provide adequate protection
against weapons of terrorism.
Communication Systems
Rapid and secure communications are crucial to ensure a prompt and coordinated
response to an intentional release of a biological agent. Thus, strengthening commu-
nication among clinicians, emergency rooms, infection control practitioners, hos-
pitals, pharmaceutical companies, and public health personnel is of paramount im-
portance. To this end, CDC is making a significant investment in building the na-
tions public health communications infrastructure through the Health Alert Net-
work (HAN). HAN is a nationwide program to establish the communications, infor-
mation, distance-learning, and organizational infrastructure for a new level of de-
fense against health threats, including bioterrorism. Currently, 13 states are con-
nected to all of their local health jurisdictions; 37 states have begun connecting to
108
local providers as well; and CDC is also directly connecting to groups, such as the
American Medical Association, to cast a broad net of coverage. CDC has also estab-
lished the Epidemic Information Exchange (Epi-X), a secure, Web-based communica-
tions system that provides information sharing capabilities to state and local health
officials. CDC also provides timely satellite broadcast and web-broadcast training
through the Public Health Training Network. For example, just last week, CDC ex-
perts shared information on anthrax with physicians, hospitals, and other
healthcare providers across the country.
Ongoing communication of accurate and up-to-date information helps calm public
fears and limit collateral effects of the attack. CDC communicates with the public
directly through its website on emergency preparedness and through a public in-
quiry telephone and e-mail system, which, since the recent attacks, has responded
to hundreds of questions daily. In addition, CDC communicates to the public by re-
leasing daily updates to the news media, answering inquiries from the press and
providing medical experts for interviews.
THE NATIONAL PHARMACEUTICAL STOCKPILE
Another integral component of public health preparedness at CDC has been the
development of a National Pharmaceutical Stockpile (NPS), which is mobilized in
response to an episode caused by a biological or chemical agent. The role of the
CDCs NPS program is to maintain a national repository of life-saving pharma-
ceuticals and medical material that can be delivered to the site or sites of a biologi-
cal or chemical terrorism event in order to reduce morbidity and mortality in a civil-
ian population. The NPS is a backup and means of support to state and local first
responders, healthcare providers, and public health officials. The NPS program con-
sists of a two-tier response: (1) 12-hour push packages, which are pre-assembled ar-
rays of pharmaceuticals and medical supplies that can be delivered to the scene of
a terrorism event within 12 hours of the federal decision to deploy the assets and
that will make possible the treatment or prophylaxis of disease caused by a variety
of threat agents; and (2) a Vendor-Managed Inventory (VMI) that can be tailored
to a specific threat agent. Components of the VMI will arrive at the scene 24 to 36
hours after activation. The NPS was mobilized for the first time on September 11,
when a 12-hour push pack was deployed to New York City, delivering 50 tons of
medical supplies to the site of the disaster in 7 hours. In addition, substantial quan-
tities of VMI were delivered to New York City within 24 hours. Components of the
VMI were deployed to Palm Beach, Florida, this month to provide adequate supplies
of ciprofloxacin to provide prophylaxis to individuals who were potentially exposed
to anthrax. CDC has developed this program in collaboration with federal and pri-
vate sector partners and with input from the states.
CORE CAPACITIES FOR STATE AND LOCAL HEALTH BIOTERRORISM PREPAREDNESS AND
RESPONSE
CDC has been working with partners at all levels to develop core capacities need-
ed to respond to pubic health threats and emergencies. CDC is also developing spe-
cific guidelines to assist public health agencies in their efforts to build comprehen-
sive bioterrorism preparedness and response programs. This collaborative effort en-
gages federal, state, and local partners in determining what is needed for state and
local public health agencies to improve their preparedness and response to bioter-
rorism. This process enables health departments to more effectively target specific
improvements to protect the publics health in the event of a biological or chemical
terrorist event and will provide the framework for future program efforts. The core
capacities effort is for dual purpose. While these capacities focus on bioterrorism
events, they are also relevant to naturally occurring infectious disease outbreaks
and natural disasters.
CHALLENGES
CDC has been addressing issues of detection, epidemiologic investigation,

diagnostics, and enhanced infrastructure and communications as part of its overall
bioterrorism preparedness strategies. Based on federal, state, and local response in
the weeks following the events of September 11, and on recent training experiences,
such as the National TOPOFF event and the Dark Winter exercise, CDC has
learned valuable lessons and identified gaps that exist in bioterrorism preparedness
and response at federal, state, and local levels. CDC will continue to work with part-
ners to address challenges such as improving coordination among other federal
agencies during a response and understanding the necessary relationship needed be-
tween conducting a criminal investigation versus an epidemiologic case investiga-
tion. These issues, as well as overall preparedness planning at federal, state, and
109
local levels, require additional action to ensure that the nation is fully prepared to
respond to acts of biological and chemical terrorism.
Disease experts at CDC are developing strategies to prevent the spread of disease
during and after bioterrorist attacks. Specific components include (1) creating proto-
cols for immunizing at-risk populations; (2) isolating large numbers of exposed indi-
viduals; (3) reducing occupational exposures; (4) assessing methods of safeguarding
food and water from deliberate contamination; and (5) exploring ways to improve
linkages between animal and human disease surveillance networks since threat
agents that affect both humans and animals may first be detected in animals.
CONCLUSION
In conclusion, CDC is committed to working with other federal agencies and part-
ners as well as state and local public health departments to ensure the health and
medical care of our citizens. We have made substantial progress to date in enhanc-
ing the nations capability to prepare for and respond to a bioterrorist event. The
best public health strategy to protect the health of civilians against biological ter-
rorism is the development, organization, and enhancement of public health preven-
tion systems and tools. Priorities include strengthened public health laboratory ca-
pacity, increased surveillance and outbreak investigation capacity, and health com-
munications, education, and training at the federal, state, and local levels. Not only
will this approach ensure that we are prepared for deliberate bioterrorist threats,
but it will also ensure that we will be able to recognize and control naturally occur-
ring new or re-emerging infectious diseases. A strong and flexible public health in-
frastructure is the best defense against any disease outbreak.
Thank you very much for your attention. I will be happy to answer any questions
you may have.
Senator HARKIN. Is there anything else? I am going to turn to
Mr. Caruso, now, from the FBI, and to brief us on, along the same
line of questioning here, what you see as the situation right now
regarding the anthrax investigation, and I will have questions for
you about this investigation.
STATEMENT OF JAMES T. CARUSO, DEPUTY ASSISTANT DIRECTOR,
COUNTERTERRORISM DIVISION, FEDERAL BUREAU OF INVES-
TIGATION, DEPARTMENT OF JUSTICE
Mr. CARUSO. Thank you, Mr. Chairman, Senator Specter, mem-
bers of the committee. I will briefly address the FBIs coordination
with State and local law enforcement agencies, the first responders
and the scientific and medical communities. Each FBI field office,
in addition to having squads responsible for investigating suspected
acts of domestic and international terrorism, has weapons of mass
destruction (WMD) coordinators. These individuals are trained to
address incidents involving chemical, biological or radiological at-
tacks or incidents that the Federal Government, State, and local
agencies need to be prepared to deal with, as we have been dealing
with over the past weeks, and this committee is discussing.
DUTIES OF WEAPONS OF MASS DESTRUCTION COORDINATORS
The WMD coordinators duties include establishing and main-

taining liaison with State and local first responder communities,
such as the police, fire, hazmat materials units, and establishing
a local FBI WMD incident contingency plan, which is our own FBI
response to a suspected or actual WMD incident.
The coordinator participates in planning and execution of State
and local WMD exercises and participates in established
counterterrorism working groups. Additionally, many FBI field of-
fices have established Joint Terrorism Task Forces, JTTFs. Pres-
ently, there are 35 JTTFs Nation-wide, with 24 of those task forces
participating in 6 Regional Terrorism Task Forces (RTTFs). As a
110
result, all 50 States are represented, receive and contribute to the

flow of information at law enforcement centers of intelligence.
JTTFs are staffed by FBI, State and local law enforcement, as
well as with other personel from Federal agencies. The FBI utilizes
the JTTFs, the RTTFs, and the National Law Enforcement Tele-
communications System, known as NLETS, to provide hazardous
materials assistance and guidance to first responders.
Beginning in 1998, the FBI, the Centers for Disease Control
(CDC), and the Association of Public Health Laboratories (APHL),
partnered together to assure a united and coordinated response to
suspected and actual biological incidents. Known as the Laboratory
Response Network (LRN), this group was composed of over 80
State public health, private, and military laboratories. The CDC
and the APHL set out the scientific protocols for the testing of
specimens. The FBI sets out the chain of evidence, or evidentiary
protocols to be used in gathering and testing specimens.
A question posed to the FBI is, what have we done to coordinate
efforts with State and local representatives on crime scenes? In the
anthrax venues such as those in Miami, New York, New Jersey,
and Washington, DC, the local FBI field offices work closely with
State and local government officials, public health agencies, and
law enforcement and first responder units, to expeditiously identify
and isolate any potential crime scene. The FBI is coordinating sam-
pling, and testing operations with the CDC and the Department of
Health and Human Services (HHS) to ensure public safety. We are
also closely aligned with the U.S. Postal Service and the Office of
the Chief Postal Inspector at the local and headquarters levels.
The FBI deployed members of its Hazardous Materials Response
Unit out of Quantico, Virginia to assist State, local, and Federal
personnel in the sampling of locations and facilities believed to be
contaminated with anthrax. Currently, there is a CDC official and
U.S. Postal Service officer assigned to the domestic terrorism sec-
tion at FBI Headquarters to ensure direct connectivity and infor-
mation-sharing.
Finally, Mr. Chairman, the FBIs mission is to investigate and to
prevent future acts of terrorism, whether committed by a single in-
dividual or a terrorist cabal.
Thank you.
BIOTERRORIST INCIDENTS AND INFORMATION
Senator HARKIN. Thank you, Mr. Caruso. I just have one more
question, and then I will turn to Senator Specter and the other
Senators who are here. This is the question I started out with.
In the bioterrorist incidents, it is necessary we tell people what
is going on. People have to have information. Our public health of-
ficials, not only at CDC but those at the State and local levels,
have to have information. Do you think there is a conflict with the
FBIs need to control that information due to the fact that it is an
ongoing criminal investigation? I am getting a sense there may be
some conflict here, and I do not know who is ruling the roost.
Is it Dr. Koplan and the people at CDC on whom we rely to do
the epidemiology of this, to track it down, to let us know where it
is coming from, how to control it and contain it? Or are you ruling
the roost in trying to go after the people who are doing it, and try-
111
ing to do a criminal investigation? How well is that being coordi-

nated? Who is running this show?
Mr. CARUSO. Mr. Chairman, the mission of the FBI is to inves-
tigate and prevent act of terrorism, thereby saving lives. We turn
to the CDC for guidance in doing that. If there is information that
is law enforcement-sensitive, or information that may tip into the
classified world, we find a way to make sure that information gets
to the proper authorities so that we can save American lives. There
is no question in our mind what our mission is with reference to
that, and we try to live up to that every day.
Senator HARKIN. I have no doubt about that.
Dr. KOPLAN. Can I expand on that a bit? We are not two agencies
that normally work together on a day-to-day basis. We have had
some contact on West Nile, and some laboratory work, as has just
been indicated. In this particular instance, from the get-go both of
us were involved in the Florida investigation, and it became clear
we were mutually dependent on each other for a wide range of ac-
tivities, and it worked extraordinarily well. That does not mean
that every day there was not a question on who does what and how
do we do it, but we got it resolved well.
We had a team leader, they had an investigative team leader. We
assigned someone from our epidemiology staff to sit in their emer-
gency operations office, and they did the same with us. We as-
signed a senior CDC person who knows this area well to come to
FBI Headquarters in Washington and sit there and we have made
great efforts to ensure an enmeshed cooperative venture in this,
and I think it has worked well.
So in terms of, they lead the criminal investigation, we lead the
epidemiologic investigation, and when we get in the way of each
other, we try to sort it out.
Senator HARKIN. Well, that is sort of the concern that I have,
and others have, too, and it is a balancing act. I assure you we
want to get these people, there is no doubt about it. But we also
want to protect people, too, so we need as much information about
what is going on so we can protect people. I can assure you there
is a great deal of concern here, when we think about that Brent-
wood facility. The fact that we were here and had exposure, and
so did Trenton, and it was not until somebody got sick there that
we finally decided to start testing people there and giving anti-
biotics, that is something that bothers us.
Mr. CARUSO. Mr. Chairman, from early on in this investigation,
under the leadership of Attorney General Ashcroft and Director
Mueller, the FBI has provided information to the State and local
representatives. One of the ways we do that most effectively is
through the National Law Enforcement Telecommunications Cen-
ter, NLETS, and that is a communications system that electroni-
cally connects us to about 18,000 law enforcement agencies across
the country.
Under General Ashcroft and Director Muellers leadership, we
have been providing information even of a general threat nature to
the law enforcement community to make sure that they are prop-
erly postured, and that we get information out.
Sometimes we have been criticized for giving information out
that was not terribly specific in particular areas. It is more impor-
112
tant to have the law enforcement and the American people be in-
formed. That is the springboard from which we in the FBI are com-
ing with reference to providing information as soon as we can get
it.
Senator Specter.
Senator SPECTER. Thank you, Mr. Chairman.
Mr. Chairman, since we are in this makeshift room we do not
have the lights on, and I am going to take 5 minutes, which is our
custom, and I would appreciate it if the clerk would hand me a
note when I have 1 minute left so I will know when my time is
up. We have a very long list of panelists beyond Dr. Koplan and
Mr. Caruso, and we have caucus luncheons where we have to fig-
ure out the schedule as to how we are going to complete our busi-
ness, so we are going to be under very tight time constraints, so
I am prepared to observe time limits meticulously.
RESONSIBILITY FOR ANTHRAX DISTRIBUTION
Mr. Caruso, it is very important that we be sure about what we

say as to who is spreading the anthrax. We speculate or wonder
if there is a connection between the September 11 attack by Osama
bin Laden and Al Qaeda and the anthrax, and until we know, we
should not jump to any conclusions.
There has also been speculation about what is happening with
Saddam Hussein and Iraq. As we know, we have not been able to
inspect Iraq for many years now, and we know that Saddam Hus-
sein has been actively engaged in bioterrorism. Is there anything
in the FBI investigation which suggests any connection to either
Osama bin Laden or Al Qaeda or Iraqs Saddam Hussein?
Mr. CARUSO. Senator, we do not have information at this point
that would make evidentiary links to Osama bin Laden or Al
Qaeda.
POSSIBLE RANGE OF BIOTERRORIST THREATS
Senator SPECTER. When you say evidentiary links, I do not think

we need admissible evidence in court, but that is something which
is very much on our minds, so while not to jump to any conclusions
at all that is something that we ought to focus on, and the sub-
committee would like a follow-up from you, if you could give it to
us, as to what your line of inquiry is and we will treat it on a con-
fidential basis.
Now, Dr. Koplan, looking at the broader picture on bioterrorism,
you hear a lot of talk about smallpox. You hear talk about anthrax.
There are concerns about water, and there are concerns about
chemicals, as the Japanese subway incident several years ago. As
a matter of public information, what is the range of possibility with
respect to bioterrorist attacks?
Dr. KOPLAN. Unfortunately, it is very broad. There is a wide
range of agents, both biological and chemical, that can be used.
Senator SPECTER. Would you furnish to this subcommittee a list
as to those substances?
Dr. KOPLAN. Sure.
Senator SPECTER. Would you also furnish to this subcommittee
a list as to what ought to be done about it? We have certain re-
113
sponses to anthrax. We would like to have an update as to what

is happening with respect to smallpox. We would like to have a
specification as to what other threats are out there, and what
ought to be done by the Government to act if we find that they
strike, and we also need to know what the cost factor is.
Senator Byrd and Senator Stevens, Senator Harkin and I wrote
to the President several weeks ago after Secretary Thompson testi-
fied asking what figure we need, and we are prepared to spend
whatever it takes, but we need to have the specifications and the
range of problems, and what the answers are and what the costs
are.
You see a lot of information about crop-dusting. What kind of a
risk is posed to Americans across the land by materials which
could be spread with crop-dusters?
Dr. KOPLAN. Again, it is difficult to determine. There is a variety
of factors in that, many of which involve the criminal FBI side of
this.
Senator SPECTER. I only have 60 seconds left, Dr. Koplan.
Dr. KOPLAN. So I should not use up a lot of it. Quickly, there are
some elements that could be sprayed in that form, but it s not
quite as simple as people would think in terms of clumping and
particle size and all of that. It is an issue.
Senator SPECTER. A last question. I have 25 seconds left, and I
want to be within the time limits. If somebody in America has a
problem, or a question, what should they do? Whom should they
call? Do you have a number, or a hotline?
Dr. KOPLAN. I think the best source of information for everybody
in the country is their local county or city health department, No.
1, their State health department, No. 2. They have been given a
wide range.
Senator SPECTER. Dr. Koplan, could I suggest we establish a na-
tional hotline so that we have one number where people could call?
Dr. KOPLAN. We have a hotline for State and local health depart-
ments but it would be virtually impossible to answer all of the calls
on a national basis.
Senator SPECTER. I am glad it is only virtually impossible.
Senator HARKIN. In order of appearance, let us now turn to Sen-
ator Murray.
TESTING OF POSTAL FACILITIES AND WORKERS
Senator MURRAY. Thank you very much, Mr. Chairman, espe-

cially for holding this hearing today.
Dr. Koplan, I know many of us are very concerned that the post-
al workers at the Brentwood facility were not tested in now what
appears, looking back, a timely manner, and given the treatment
that many people here on the Hill were given almost immediately,
and I think that is very disconcerting to many of us here.
It seems to me, if I remember correctly, that we knew on
Wednesday that there was anthrax on a mail machine in the Dirk-
sen Building. At what point did we go backwards from there and
start checking where did this mail come from? Obviously, it is on
a postal machine in Dirksen, and where was it before, and why was
114
there a gap between that and the Brentwood facility and beginning
to take a look at whether there was exposure there?
Dr. KOPLAN. Thank you, Senator Murray. Before you came in I
offered to get a chronology of this for Senator Harkin. The presence
of environmental isolates in places does not necessarily correlate
with people getting ill from the disease, and as I indicated, there
had still been no evidence of inhalation anthrax in a place where
people had not opened mail, and that is the change in what we
learned in this instance.
On the Wednesday you are referring to, I do not think we had
received, or anyone had received results of any isolations from the
Brentwood facility. There was an association with a sorting ma-
chine inand I am not sure where the environmental specimen
was from in Dirksenthe mail room, but I believe the investigation
had continued at that point, looking again downstream. There is a
P Street station that was looked at, and then Brentwood after that.
Senator MURRAY. So that was ongoing?
Dr. KOPLAN. I believe it was.
Senator MURRAY. Well, obviously we have learned a lot in a week
in terms of unopened mail, opened mail, where exposure can be
and all of that, and I am curious, are we now putting together a
protocol so that the next time a letter appears some place we will
know immediately how to backtrack it?
Dr. KOPLAN. Well, we have been trying to put together protocols
at each day in this, and have had to change them each day based
upon new information as it comes in, and absolutely we have been
working for several days with the Postal Service and others to try
to come up with what is a rational and the best approach to take
to make workers safe in the postal facilities.
It has to change based upon new information, but we are dis-
cussing on a daily basis with the postal authorities and their
unions and everyone else involved what are the best steps we can
take. Some of this I will tell you is somewhat arbitrary, and we are
not sure on all of these things, but we are going to try to step as
far over towards workers safety as we possibly can to get this
thing done.
Some of the questions are, what type of protective barriers
there has been a focus on protective barriers of gloves and masks,
et cetera, and which are the best of those to use. It is more com-
plicated than just saying gloves and masks. For some of the equip-
ment I understand postal workers use there can be a danger in get-
ting a hand caught, or something caught.
PROPER PROCEDURES TO HANDLE OPENING OF MAIL
Senator MURRAY. And I think that goes to my second concern.

Everybody hears something different. Are we doing research quick-
ly, I mean, really quickly to let postal workers or people in offices
who open mail know what is the proper procedure? We hear from
one group to wear gloves, we hear from another do not wear gloves.
Dr. KOPLAN. We are not waiting for research for this. We are try-
ing to bring folks who have the most to offer, and it is mixed skill
sets, occupational experts and occupational health and safety.
Senator MURRAY. How soon will we know what those rules are?
115
Dr. KOPLAN. We are meeting later today to talk about it, but I
would rather have rules that make sense and work, rather than
just get rules out in the next couple of hours. We will be working
as quickly as we possibly can to get valid and appropriate rules
out, in the meantime trying not to put anyone at further risk.
Senator MURRAY. I think that is really important, that people
just have the facts so that they know how to deal with this. Most
people just want to know, how do I protect myself?
GETTING INFORMATION TO HEALTH CARE PROFESSIONALS
My time is almost up. I have a few other questions. It seems to

me there was so much information in the press and everywhere we
went about anthrax. How could it possibly be that someone showed
up at a health care professionals office and was turned away and
sent home who may have been exposed to anthrax and subse-
quently died? How do you get information out there? Where was
the hole?
Dr. KOPLAN. Well, we have had a number of people who have
recognized it, or whose antenna went up and reported it both in the
cutaneous cases in New York and in the case in Florida and some
other instances. In this particular instance, when doctors or health
professionals see people it is not always obvious what that is, and
unfortunately in the early stages of inhalation anthrax it can look
like any one of a number of things that people see hundreds of
cases of every day, and again, it is easy for me sitting here think-
ing that I might have thought, well, maybe it is anthrax, I probably
would not if someone comes in with a cough and a cold and a head-
ache.
The difference now is, I think the level of suspicion is up all over.
Nevertheless, it is hard for me to find fault with an individual in
that circumstance, and one of the issues in this particular unfortu-
nate patient was the rapid deterioration that occurred after what
was seemingly symptoms like you see for a large number of other
illnesses.
A key issue here, and an important issue for the public and the
health education message is, it is the combination of those symp-
toms and where this person worked, and that is the key linkage.
Senator MURRAY. That was my last question. Is that going to be
part of the protocol for doctors to understand?
Dr. KOPLAN. Yes, and now one of the things is we have associa-
tion with handling mail, and not just opening mail, that that has
got to be raised, and it is one of the things that all health profes-
sionals now have to say to people is, you have got a cold, you have
got a cough, you have got a fever, now what kind of job do you do
and where do you do it, and do you handle mail. It is again some-
thing we would not have asked 2 weeks ago that we need to ask
now.
Senator MURRAY. Thank you very much.
Senator HARKIN. Thank you, Senator Murray.
Senator Landrieu.
Senator LANDRIEU. Let me just begin by following up briefly, and
thank you, Mr. Chairman, for holding this hearing, and our Rank-
ing Member, for the timeliness of this hearing.
116
But to follow up with what Senator Murray said, it does seem

difficult to fathom, though, how here in the District, that anybody
showing up at a hospital who was a postal worker with flu-like
symptoms could have been sent home. I just think we need to ex-
plore that in a little bit more detail, because it is important, as the
chairman said, to learn our lessons quickly, because of course these
families have suffered tremendous loss, and there are thousands
and thousands of postal workers and families and children of the
postal workers and mothers and fathers of postal workers through-
out the Nation that are obviously very, very concerned. So it is very
important, Mr. Chairman, that we learn that lesson quickly and
apply it.
Second, I think to keep this in perspective, because I think it is
important for all of us, the Members of Congress and the public
generally to do that, I found a quote that Samuel Adams gave in
a speech in 1771, and I thought, Mr. Chairman, I would share that.
He says: the necessity of the times more than ever calls for our
utmost circumspection, deliberation, fortitude, and perseverance.
Let us remember that if we suffer tamely a lawless attack upon our
liberty, we encourage it, and involve others in our doom.
Now, of course, this was prior to the Revolution, but throughout
the history of our Nation we have had very serious attacks, and
this is one that we are in.
Another point I want to make, and we continue to refer in this
hearing to this outbreak, this anthrax outbreak, I would suggest
that we use a little tougher language to understand what we are
in, because this is an attack. We do not know the perpetrators. We
do not know the exact linkages, but we do know enough of the sub-
stance to realize that someone most certainly intended this act to
cause death and destruction and disruption, and to a certain degree
they obviously have been successful, and so this is not just our
usual public health situation. This is a purposeful, merciless attack
in this way, and it may not be, unfortunately, the last time that
we see it.
PROUD POSTAL WORKERS AND AWARENESS
The next point is that I have shared with my staff, and many
of the Senators and House members have expressed this to their
staffs, that although we do not show up in a uniform, we wear reg-
ular clothes, we are, this staff here, like we wear a uniform. The
postal workers out there, I want them to be proud of the uniform
that they wear, because everything that we do, whether it is open-
ing mail, delivering mail, preparing for hearings like this, giving
speeches, conducting hearings in very difficult circumstances like
the chairman has had to put this hearing together, and all of you,
it is a way that we stand up to the flag every day, and I hope that
we can communicate that.
There is no sense in blaming, but we do need to get about quick-
ly finding some answers, and so for my question, I wanted to ask
the FBI, because we went to the web site and looked at the advi-
sory that has been put out for letters that is on the FBI web site,
and it is obvious to me just looking at this that we might need to
revise the web site somewhat. It talks about letters, for us to be
aware of. Be aware of letters, it says, with no return addresses. Be
117
aware of letters with postage that is more than necessary. Be

aware of letters that are postmarked or post-stamped from a for-
eign source.
Well, these letters, at least the letter to Senator Daschle that we
know of, had a return address from a fourth grade class in New
Jersey, it was clearly marked, the postage was mailed from a do-
mestic box with a local postmark in New Jersey, so I think that
is what Senator Murray and others are referring to. We realize we
are all learning, but the faster we learn, and the more clear, spe-
cific, reliable information that we can put out there, the better. I
would only ask, first, and I know I have got a minute left, can this
be revised, and should it be?
My second question is, what is the FBI doing to rely on and con-
nect to the military, which does have a lot of experience dealing
with weapons of mass destruction, which this most certainly is?
And my third question to the FBI is, of the 2,300 incidents that
you say that have been reported, could you provide to the chair-
man, because we do not have time to go over this, our time is short,
how many of those incidents were shared with local law enforce-
ment, and how many were not? I think that would be important
for this committee to know so we can see if the local law enforce-
ment is, in fact, getting the information that they need to be get-
ting.
And finally, you can submit this for the record later, because we
do not have time, what is the penalty for hoaxes that the FBI is
either suggesting for Congress to consider, or suggesting for local
legislators to take up across this country, because Mr. Chairman,
the last thing we need is for our resources to be stretched with peo-
ple who are sort of conducting hoaxes on their own. I think the
swiftest penalties need to be given out so that we can nip this in
the bud and give the American people the confidence and the com-
fort they need.
You can answer one or two for the time, and then if you would
just submit the rest in writing. Thank you.
[The information follows:]
INFORMATION SHARING WITH LOCAL LAW ENFORCEMENT
The response to suspected Weapons of Mass Destruction (WMD) threats or inci-
dents typically involves both the Federal Bureau of Investigation FBI and local law
enforcement entities. In reference to the 2,300 mentioned incidents, the majority (no
specific number available) were investigated by both FBI and local law enforcement.
The FBI maintains weekly statistics of all FBI responses to suspected or actual
WMD threats or incidents to include anthrax. For the period between September 11,
2001, and November 19, 2001, the FBI responded to approximately 14,000 incidents
throughout the United States in which the distribution/release of anthrax was sus-
pected, as well as responding to approximately 750 incidents in which other WMD
were suspected of being involved. The FBI response to these incidents was based
on information that it received from a variety of sources, to include referrals from
local law enforcement and first response entities and telephonic tips from the gen-
eral public. The FBI takes each and every report seriously and expends the re-
sources necessary to address the threat and provide a measured response.
As noted in Mr. Carusos statement, the FBI has established several mechanisms
that facilitate the sharing of WMD-related information with local law enforcement
entities. The working relationships emanating from the existence of Joint Terrorism
Task Forces/Regional Terrorism Task Forces (JTTF/RTTF) and the outreach efforts
of field office WMD coordinators have resulted in the establishment of mechanisms
for the exchange of information with local law enforcement entities. These mecha-
nisms, which can include passing information to local police officers on a JTTF or
118
telephonic contacts between a field office WMD coordinator or management official
and the appropriate counterparts at local law enforcement entities, serve as the
means for timely dissemination of information regarding incidents in which a WMD
is suspected of being involved.
FIRST RESPONDERS
Mr. CARUSO. I think your suggestions on the announcement

there are very wise, and we will see if we can incorporate those to
make them look a bit more like some of the letters you referred to.
I think that is a very good observation. Thank you for that.
We are working closely with the Department of Defense in those
areas where we can. For example, we use their institute to take a
look at some of the anthrax or the material that they determine to
be anthrax, and we have a very good, close working relationship
with them, as well as with CDC. With reference to the 2,300 inci-
dents, I will get you that information.
Specifically, my expectation is the vast majority, if not all of
them, have local law enforcement involvement because local law
enforcement or fire departments are really the first entities who
are called by an individual who says, I have a strange and sus-
picious package before me. What do I do? It is the first responders,
the local law enforcement agencies and five departments that are
the first responders. But I can get you some more specific informa-
tion. My expectation is the vast majority will have local
connectivity and response with the FBI.
PENALTIES
The hoaxes penalty issue is something that I will talk with the
Department of Justice about. The Attorney General, as you know,
and Director Mueller have vigorously gone after and arrested indi-
viduals who have played hoaxes to show individuals that their
comedic attempt is not appreciated, and we will apply the full ex-
tent of the law against what they have done. There have been a
number of instances in that regard. Increasing penalties is some-
thing to be discussed with the Department of Justice.
Thank you.
PENALTY FOR HOAXES
Prior to October 23, 2001, no penalties existed for weapons of mass destruction
hoax devices in the Federal Criminal Code. However, within sections 175 (biologi-
cal weapons), 229 (chemical weapons), 831 (nuclear material), and 2332a (weapons
of mass destruction), it is illegal to threaten the use of such weapons. The threat-
ened use of a WMD does not constitute a hoax, but involves the articulated threat
that a chemical, biological, nuclear, radiological, or high explosive device is present.
A statute is needed which specifically addresses instances in which an individual
falsely reports the presence of a WMD or the action does not rise to the level of
a threat. The proposed language, H.R. 3209, satisfies this law enforcement need.
Specific to the question regarding current penalties under these statutes:
Section 175.As of October 24, 2001, Section 175 was amended pursuant to the
Patriot Act to include a penalty provision, 175 (c), which includes fines and impris-
onment of not more than 10 years or both.
Section 229.As defined under 229A, Criminal penalties include: fines or impris-
onment for any term of years, or both; death penalty or life imprisonment where
violation of 229 results in the death of another person; and, Civil Penalties may in-
clude an amount not to exceed $100,000.
Section 831.As defined under 831 (b), Criminal penalties include: a fine and im-
prisonment for any terms of years or life, depending on relevant conduct.
119
Section 2332a.As defined under 2332a (b), imprisonment for any term of years
or life; and if death results, punishment by death, or any term of years or for life.
Under the proposed H.R. 3209, an individual who violates this statute may be
fined or imprisoned for not more than 5 years.
ANTHRAX AND SMALLPOX AS BIOTERRORIST TOOLS
Senator HARKIN. Senator Craig.

Senator CRAIG. Mr. Chairman, thank you. Again, I would echo
my colleagues appreciation for the timeliness as we work with peo-
ple like our folks at the FBI and the CDC to learn as we go, and
hopefully gain very rapidly from these experiences.
In what we have had made available to us as it relates to the
use of anthrax as a bioterrorist tool, it appears that while it does
and can take life, and we are now experiencing that, it is rather
limited in its application. The ability to apply it to a wide range
of the population would be more difficult, and we do have the ap-
propriate medical application, and we are on alert, if you will to
largely save lives and how to substantially lessen impact on the
populace.
I think it was the Soviets, when they were developing bioterror-
ists, said they had more of a psychological impact on a society than
an actual, physical impact, and we are learning that, although it
is not in any way to suggest that what has occurred is not impor-
tant, and we are very concerned about it.
We hear a great deal, though, being talked about in the media,
and therefore the public is concerned about smallpox, the dis-
continuation of the kinds of treatments we have had in the past for
our children to be inoculated some number of years ago, wiping it
off, or believing we have wiped it off the face of the earth.
Doctor, could you tell the committee, or talk to the committee
briefly aboutand I know you are going to list these and provide
us additional informationthe ability to apply smallpox to a broad-
er base of the population? It has a tool of bioterrorism versus that
of anthrax. Now, we are talking about 19-plus million inoculations
available, or something in that range. We are proposing to spend
a great deal more money and possibly attempt to inoculate the
whole population in this country and get back into the business of
inoculation. I think that all has to shape itself with the use of it
as a tool and the ability to apply it as a tool to expose a broad pop-
ulation base in this country.
What are the factors? What are the risks?
Dr. KOPLAN. Thank you, Senator Craig. My first job in public
health was working in the smallpox eradication.
Senator CRAIG. Then I have asked the right person.
Dr. KOPLAN. I do not know about that. I had two roles, one when
I started in 1972 at CDC it was to discourage the routine, contin-
ued use of smallpox vaccination, because we had determined that
the risk of the vaccine outweighed the benefits of being vaccinated,
because the risks in the U.S. were so low at that time.
The other half of my job was to work on the worldwide smallpox
eradication, including doing clinical care of patients with smallpox
in Bangladesh. I thought that this was a wonderful experience. At
the end of those 2 years I would never have to use this information
again, and it shows you how humbling health and public health
120
events are, that something that I had hoped would remain history
is something that is very much now present upon us.
The issues you raise are considerable. The vaccine which we are
in the process of funding in, and we will hear from a colleague who
is actively involved in the production of this vaccine, we have a
contract in for the production of many more millions of doses of
this vaccine. Some of the issues are, should it be deployed, should
it be held and await its need, how much vaccine is necessary?
The decision of the Department has been, and we are part of
that, is that it is valuable to have enough vaccine should we need
it for every American in the country. The widespread use of the
vaccine, though, would be attendant with a certain number of pre-
dictable adverse reactions, including enough for hospitalization,
enough for people to have if there is an encephalitis attached to it.
So that is the balance that has to be taken into play, is both the
investment in the vaccine, which I think is worthwhile, but wheth-
er to deploy it prior to is an issue of, you will certainly have people
severely ill, and some deaths from the use of the vaccine alone, and
then that has to be matched with the risk of introduction and the
threat.
SMALLPOX PREVENTION AND USE AS A THREAT
One of the advantages of smallpox vaccine, there is no treatment

for smallpox. There is no antibiotic, no antimicrobial, no antiviral
that has been proven effective against smallpox, so the vaccine is
the only preventive device, and yet it is a vaccine that can be used
in the first few days of exposure, which is quite unusual, and gives
us some leeway to get it into people in those first few days of expo-
sure.
Senator CRAIG. You are suggesting, then, if there is a known ex-
posure of a population base and we have a vaccine available, they
can be treated and it would lessen the impact of that exposure dra-
matically?
Dr. KOPLAN. It can prevent the disease, but a key element of that
is not just the production of the vaccine, and let me emphasize to
all of you, it is the ability of State and local health departments
to then distribute that vaccine and get it into people, and the de-
gree to which State and local health departments are pressed now,
they would be sorely tried, with current resources, to get those vac-
cines into people. They do it, but they would sure need some help
in getting it done.
Senator CRAIG. Mr. Chairman, I understand I have a little time
left. I did ask another question that was maybe a bit elusive, and
that is the ability to use it as a tool of bioterrorism, and therefore
the ability to apply it.
Dr. KOPLAN. This is smallpox itself?
Senator CRAIG. Smallpox itself, comparatively to anthrax.
Dr. KOPLAN. I think one, and I hate to even use this phrase, but
one aspect of anthrax which is in all of our advantages is, it cannot
spread from person to person. It is not contagious. It is horrible
when one person gets it, a tragedy when that person dies, but it
cannot be spread from that person to another person.
Smallpox is a contagious illness, and can be spread from person
to person, making itwe have a vaccine for it, but it is contagious,
121
so with each of these agents, there are different approaches, dif-

ferent ways of dealing with it, and different downsides to them that
makes them more difficult, one than another.
ANTHRAX ANTITOXIN
Senator HARKIN. Senator Hutchison.

Senator HUTCHISON. Thank you, Mr. Chairman. Dr. Koplan, I
picked up the Austin American Statesman on October 10, and the
headline is: UT researchers close in on antidote to anthrax toxin.
It appears that there is a consortium of the University of Texas,
Texas Tech, and the University of South Florida that has been test-
ing an anthrax antibody on mice, and that the antibody has been
demonstrated to kill the anthrax bacteria.
The next step for them is to inject the mice with live anthrax,
rather than just the anthrax toxin, and test it there, but they say
they are some weeks away from this antidote. I wondered if you
are aware of this. My original intention had been to see if we could
get the money from the emergency appropriations bill we have al-
ready passed to let them proceed with their experiments on an ex-
pedited basis, particularly considering the ongoing threat of an-
thrax attacks. So I just wanted to ask you if you were aware of this
research, and whether or not you think there is something that we
might be able to do to facilitate these experiments?
Dr. KOPLAN. Thank you. That certainly sounds promising. I was
aware of antitoxin work going on. I did not know the particulars
of this experimentation. There is a real time gap between mouse
experiments and work there, and then getting it into humans,
which even in trying to increase the amount of research, it still
takes time to sort out the experimentation. I would be glad to have
folks look into it and see whether we can make direct linkages.
Certainly FDA would have an interest in this, and NIH as well,
and we would be glad to get the information.
Senator HUTCHISON. That is exactly what I want. I want to do
all the right things, but I am sure that if the NIH and the FDA
and you are working on something, perhaps we could speed it up
if this is going to continue to be the urgent problem that we see
it, at least isolated in this area. I would like to just try to do every-
thing we can to get it on the right track and shorten the timetable
if, in fact, it would help save some of these lives that have already
been hurt by this anthrax.
ANTIBIOTICS FOR USE AGAINST ANTHRAX
Thank you, Mr. Chairman, for giving us this opportunity.

Senator HARKIN. Thank you, Senator Hutchison. Just one last
thing. In every instance of anthrax exposure during the past 2
weeks, Cipro has been prescribed, but my understanding is the
FDA is officially approving the use of two additional generic anti-
biotics for the treatment of anthrax, doxycycline and penicillin. My
question is, why are we giving people Cipro when other drugs are
available? Secondly, can people who are now on Cipro switch to a
cheaper drug?
Dr. KOPLAN. Expense has not been our primary consideration to
get started. As you indicated, there are several antibiotics that can
be used in this, and in the antibiotic sensitivities we have gotten
122
from the organisms we have isolated from these different outbreaks

there are a number of antibiotics that seem susceptible to it.
I believe today we are coming outwe have gotten a group of ex-
perienced clinicians, people who care for people and take care of
people and engage in treatment for infectious diseases to spell out
alternative antibiotic guidelines, but Cipro remains a primary drug
of choice for people who are sick with the disease. Other antibiotics
may also be used in that regard for people who are taking it in a
preventive way, such as folks exposed, or in the city Cipro might
be a reasonable start and then shift after a period of time to
doxycycline. All of these things have some side effects to them, and
so probably the thing is to explain to people what the options are
for them and both make a suggestion to them, but let them choose
which they think would be best for them as well.
An example is doxycycline, you cannot go out in the sun with it.
It causes a skin rash if you are in the sun. That might not be an
issue for most of us who spend all of our time indoors, but certainly
in Florida it was not something we wanted the people exposed to,
so it is a balancing act, but you are absolutely right, doxycycline,
there has been this rush for Cipro, but doxycycline works terribly
well, and we would recommend it.
Senator HARKIN. And penicillin?
Dr. KOPLAN. Penicillin, our folks are looking at in a little more
detail in the lab as to whether in the isolates we are seeing wheth-
er that is going to be recommended. I think at the moment I would
stick with doxycycline or Cipro for these cases we are seeing now.
Senator HARKIN. Dr. Koplan, Mr. Caruso, thank you very much.
I think you have given us some good reassurances. I think what
you have just spelled out indicates that CDC is on track, and I am
hopeful that we will continue to get the kind of information we
need and support for our public health agencies. Thank you so
much.
Our next panel will include Mr. Robert Kramer, president and
chief operating officer of the BioPort Corporation, who is accom-
panied by Robert Myers, who is a doctor of veterinary medicine and
is executive vice president of Bioport; Mary Kuhn, vice president
of Bayer Corporation, makers of Cipro; Thomas Monath, vice presi-
dent of research and medical affairs for Acambis, the makers of
smallpox vaccine; Hilary Koprowski from Thomas Jefferson Univer-
sity; Mary Gilchrist, director of the University of Iowa Hygienic
Lab; and Barbara Hunt, district health officer for the Washoe
County health department in Nevada.
Again, I would ask if you have any lengthy types of documents,
if you would submit those for the record. Barring any objections,
all of your statements will be made a part of the record in their
entirety. I would hope that you could, in less than 5 minutes, sum
up for us your views and your opinions of what has happened dur-
ing the recent events, and any advice and suggestions you have for
us as we pursue this. With that, I would open first with Mr. Bob
Kramer of the BioPort Corporation.
123
STATEMENT OF BOB KRAMER, PRESIDENT AND CHIEF OPERATING
OFFICER, BIOPORT CORPORATION, ACCOMPANIED BY DR. ROB-
ERT MYERS, EXECUTIVE VICE PRESIDENT
Mr. KRAMER. Thank you, Mr. Chairman. I want to thank you for
your invitation to discuss the anthrax vaccine and the current sta-
tus of the vaccine production, and the process we have been work-
ing through with the FDA. In addition, I will use this opportunity
to set the record straight on BioPort and our FDA licensed anthrax
vaccine.
Before I begin, I would like to introduce Dr. Robert Myers, our
executive vice president of BioPort, who will assist me in answer-
ing your questions.
The history of the anthrax vaccine begins in Michigan, with its
Department of Public Health. During the 1920s, Michigan was one
of several States with its own vaccine research facility. Michigan
developed a number of critical vaccines to protect public health, in-
cluding one of the first combined pediatric vaccines in the country.
In response to Department of Defense requests, the Michigan facil-
ity took over development of the anthrax vaccine in 1965, when no
one else was interested, and in 1970 a U.S. license was granted for
the Michigan anthrax vaccine, the only FDA licensed anthrax vac-
cine in the Nation.
From 1970 to 1989, the Michigan facility shipped 68,000 doses of
the anthrax vaccine. Then in 1990 Iraq invaded Kuwait, and the
Persian Gulf conflict began. The Michigan plant stepped up again
to meet the needs of the U.S. military at the request of the Depart-
ment of Defense. During the past 10 years, the FDA has continued
to increase its compliance standards for biologics manufacturers.
These higher standards more fully assure that vaccines and other
biologic products will continue to be safe, pure, and effective. We
fully support these higher standards.
By 1996, in the midst of having amassed a sizeable stockpile of
anthrax vaccine, the State of Michigan facility faced a serious regu-
latory challenge. Consequently, in 1997 the State moved forward
with its decision to sell the assets of the facility. Meanwhile, to ad-
dress these concerns, Michigan State government officials, in tan-
dem with the Department of Defense, decided to suspend produc-
tion of the anthrax vaccine in January of 1998 to begin a long-
planned, much-needed renovation of the facilities.
BioPort Corporation, the only U.S. company participating in the
final round of bids, acquired the facility from the State of Michigan
on September 4, 1998, and became responsible for the renovation.
We completed the renovation process, resumed production in 1999,
and submitted our biologics license application supplement to the
FDA. The FDA subsequently conducted a preapproval inspection,
and identified more work in order to get the facility approved.
BioPort immediately prepared a detailed plan. The FDA has con-
curred with that plan, and we have since met regularly with them,
briefing them on our execution. We submitted our amended bio-
logics license application supplement to the FDA on Friday, Octo-
ber 12 of this year, and are confident that this submission, the cul-
mination of 20 months of work, satisfies all FDA requirements and
will allow the agency to complete its comprehensive review and ap-
124
proval process. We stand ready to respond to any additional ques-

tions raised by the FDA during this review period.
The events of September 11 and the subsequent intentional expo-
sure to anthrax have undoubtedly changed the landscape of public
health and protection from terrorist attacks for years to come. As
well, recent national events have altered the profile of the BioPort
Corporation, a privately held vaccine manufacturer that employs
220 people.
The media coverage of anthrax exposures, and the subsequent
public health response, was initially characterized as an Olympics
of misinformation. As it relates to BioPort Corporation and its vac-
cine, this is certainly the case. I would like to correct some of these
myths that have been out there.
Senator HARKIN. I am going to ask you to collapse them. I think
they are very good, but you cannot read them all. We do not have
the time. Just give us the myth and a brief fact.
Senator KRAMER. The first myth was the anthrax vaccine is not
safe and may not be effective. The truth is, there are over 18 stud-
ies by independent professionals who consistently demonstrate and
show the vaccine is safe, and as well the FDA has consistently tes-
tified to the same.
The second myth is that we have failed to produce any anthrax
vaccine since acquiring the facility from the State of Michigan.
Contrary to this, BioPort has maintained and significantly added
to a significant stockpile of the anthrax vaccine and can make it
available, with the concurrence of the Department of Defense who
owns the anthrax vaccine stockpile, to the CDC, who would make
the medical determination when it is necessary, and the FDA must
release the product.
The third myth was that BioPort has been mismanaged since ac-
quiring the facilities from the State of Michigan. The fact is that
we have hired and been successful in bringing in a number of expe-
rienced managers from the industry and technical experts, and we
have the right people doing the right things to get this job done,
and we will get the approval of the renovated facility.
The funding from the Department of Defense in the last 3 years
has been substantial, and BioPort is grateful for the Department
of Defenses continued support, but these expenditures need to be
placed in the overall perspective of the industrial cost of vaccine de-
velopment and manufacture. It is comforting to hear from Senator
Specter that you are prepared to spend whatever is necessary to
make sure these important products are made available.
Senator HARKIN. How much would it cost?
Mr. KRAMER. I guess I would have to ask, cost to do what?
Senator HARKIN. To vaccine Americans with this vaccine.
Mr. KRAMER. For all public citizens?
Senator HARKIN. Yes.
PREPARED STATEMENT
Mr. KRAMER. If you are talking about 300 million people, our
contract right now with the Department of Defense has us selling
the vaccine to them for just under $11 a dose. That will likely in-
crease as we work with the Department of Defense in the current
contract, but that is probably a good ballpark.
125
Senator HARKIN. Over $3 billion. Thank you very much, Mr. Kra-
mer.
PREPARED STATEMENT OF BOB KRAMER
Good afternoon Chairman Harkin and esteemed members of the committee. Im
Bob Kramer, President and Chief Operating Officer of BioPort Corporation. I want
to thank the members of the committee for the invitation to discuss the history of
the anthrax vaccine, the current status of vaccine production, and the approval proc-
ess we have been working through with the FDA. In addition, I will use this oppor-
tunity to set the record straight on BioPort and our FDA-licensed anthrax vaccine.
Before I begin, I would like to introduce Dr. Robert Myers, Executive Vice President
of BioPort, who is with me today to assist in answering your questions.
VACCINE HISTORY
The history of the anthrax vaccine begins in Michigan, with its Department of
Public Health. During the 1920s, Michigan was one of several states with its own
vaccine research facility. Michigan developed a number of critical vaccines to protect
public health, including one of the first combined pediatric vaccines in the country.
Anthrax was a disease feared by a limited population, particularly by textile
workers who handled imported wool and hides, and farmers and ranchers who
worked with livestock.
The Department of Defense conducted the initial work on an anthrax vaccine. The
departments results were outlined in a patent that highlighted the concept of the
vaccine and its manufacture. Merck produced some initial lots of a further devel-
oped vaccine in the 1950s for the original field tests. The company declined contin-
ued work on the vaccine.
In response to a Department of Defense solicitation, the Michigan facility took
over development of the anthrax vaccine in 1965, and, in 1970, a U.S. license was
granted for the Michigan anthrax vaccinethe only FDA-licensed anthrax vaccine
in the nation.
From 1970 through 1989, the Michigan facility shipped 68,000 doses of the an-
thrax vaccine. Then, in 1990, Iraq invaded Kuwait, and the Gulf War began. Since
Saddam Hussein had developed anthrax weapons, the Michigan plant stepped up
production to meet the needs of the U.S. military at the request of the Department
of Defense. Approximately 400,000 additional doses were shipped to protect our
service members during the Gulf War.
During the past ten years, the FDA has continued to increase its compliance
standards for biologics manufacturers. The agency now requires manufacturers of
biologics to meet the highest global standards for process validation and Good Man-
ufacturing Practices. These higher standards more fully assure that vaccines and
other biologic products will continue to be safe, pure and effective. We fully support
these higher standards. Another dynamic has occurred in the past 10 yearsa de-
clining interest in vaccine production, due principally to the aforementioned rising
compliance standards and the diminishing profitability of vaccines. This is particu-
larly true for bio-defense vaccines, where the non-government market is uncertain.
Beginning in 1996, the State of Michigans facility faced serious regulatory chal-
lenges. In 1997, the State made the decision to sell the assets of the vaccine facility,
and allow private business to assume the renovation and subsequent production of
vaccine.
Meanwhile, in January of 1998, Michigan state government officialsin tandem
with the Department of Defensemade the decision to suspend production of the
anthrax vaccine in order to begin a long-planned and much-needed renovation of the
facility. BioPort Corporation, the only U.S. company participating in the final round
of bids, acquired the facility from the state of Michigan on September 4, 1998. One
of the early decisions we made was to suspend all production of other biological
products so we could concentrate on the anthrax vaccine.
And so the renovation of the facility became BioPorts responsibility. We com-
pleted the renovation process and resumed production in May 1999. BioPort sub-
mitted its Biologics License Amendment supplement to the FDA in August 1999.
The FDA subsequently conducted a pre-approval inspection in November 1999, and
imposed additional requirements before approval of the renovated facility would be
granted. The additional requirements were directly related to the higher standards
imposed by the FDA on vaccine manufacturers.
BioPort immediately prepared a detailed plan for meeting the additional require-
ments and presented it to the FDA in January 2000. The FDA concurred with the
126
plan and implementation by BioPort began. Since then, we have met regularly with
FDA representatives, providing updates on our progress. We submitted our amend-
ed BLA supplement to the FDA on Friday, October 12, 2001 and are confident that
this submissionthe culmination of 20 months of worksatisfies all FDA require-
ments and will allow the agency to complete its comprehensive review and approval
process. We stand ready to respond to any additional questions raised by the FDA
during this review period.
MYTHS VS. FACTS
The events of September 11, and the subsequent intentional exposures to anthrax
have undoubtedly changed the landscape of public health and protection from ter-
rorists attacks for years to come. As well, recent national events have altered the
profile of BioPort Corporationa privately held vaccine manufacturer that employs
220 people.
The media coverage of anthrax exposures and the subsequent public health re-
sponse was recently characterized as an Olympics of misinformation. As it relates
to BioPort Corporation and its vaccine, this is most certainly the case. I will first
point out the myths and then lend clarification.
Myth.The anthrax vaccine is not safe.
Fact.The safety of this vaccine is well documented. It is one of the most studied
vaccines. To date, 18 human studies and the CDCs independent expert Advisory
Committee on Immunization Practices have assessed the safety of the anthrax vac-
cine. Some of these studies stretch back many decades. They also include very close
scrutiny of more than two million doses of anthrax vaccine given to over 500,000
recipients over the past three years. The side effects of this vaccine are similar to
those of other vaccines routinely administered to both adults and children.
An independent, civilian vaccine expert safety panel, the Anthrax Vaccine Expert
Committee (AVEC), has reviewed all reported reaction rate data and found no evi-
dence of a causal link between the vaccine and serious, long-term medical condi-
tions. As of October 2, 2001 the AVEC has reviewed 1,623 adverse event reports
obtained through the FDAs Vaccine Adverse Event Reporting System. From these
reports, there were 57 that involved hospitalization. The AVEC found that only 10
of these were likely caused by the anthrax vaccine. All 10 involved allergic, inflam-
mation reactions at the injection site and the patients have since recovered.
The FDA has concurred with this assessment. On October 3, 2000, Mark
Elengold, Deputy Director of the Center for Biologics Evaluation and Research, in
testimony to the House Government Reform Committee, commented about the 1,561
adverse event reports that had at the time been submitted. He said: None of these
events, except for the injection site reactions, can be attributed to the vaccine with
a high level of confidence, nor can contribution of the vaccine to the event be en-
tirely ruled out. With the exception of injection site reactions, all of the adverse
events noted above occur in the absence of immunization. He further went on to
say, FDA continues to view the anthrax vaccine as safe and effective for individuals
at high risk of exposure to anthrax, when used in accordance with the approved la-
beling.
Earlier that year, on April 13, 2000, before the Senate Armed Services Committee,
Dr. Kathryn Zoon, the Director of the Center for Biologics Evaluation and Research,
said in her concluding remarks: We believe the anthrax vaccine is a safe and effec-
tive vaccine for the prevention of anthrax diseasean often-fatal diseasewhen
used according to FDA approved label.
In conclusion, on the topic of safety, extensive studies of those vaccinated as well
as independent review of reported adverse events, lead to the certain conclusion
that anthrax vaccine is safe. The FDA, in its testimonies before congressional com-
mittees, has also stated it has found the vaccine to be safe.
Myth.BioPorts anthrax vaccine is not effective.
Fact.The effectiveness of the anthrax vaccine was documented in three ways:
Clinical trials showing protection of human subjects exposed to the infectious
agent;
Demonstration of a measurable immune response following immunization;
Demonstration of protection of immunized animals when challenged with the
infectious agent.
I will now describe these in further detail.
Clinical Trials.A single-blinded well-controlled trial was conducted in the 1950s
by Dr. Phillip S. Brachman and co-workers in the employees of four U. S. textile
mills. Those workers were processing imported goat hair known to be occasionally
contaminated with anthrax spores. A similar but less potent predecessor to the cur-
rent vaccine was used in this trial. A total of 26 cases of cutaneous and inhalational
127
anthrax occurred during the course of the trial. The efficacy of the vaccine in pre-
venting anthrax was found to be 92.5 percent. In one of these mills, five cases of
inhalational anthrax (four of them fatal) occurred among the unvaccinated workers.
No cases of inhalational anthrax occurred in mill workers who had received the an-
thrax vaccine. With the occurrence of these inhalational anthrax cases, the study
was stopped in the mill so that all employees could be offered immunization since
it would have been unethical to continue the study. The number of cases of inhala-
tion anthrax was, thus, too small to demonstrate a statistically significant decrease
in the vaccinated group. Following universal immunization of employees in this mill,
the occurrence rate of anthrax fell precipitously. The FDA has subsequently indi-
cated at Congressional hearings that based on the data from this clinical trial, when
supplemented by additional case control studies in humans, and studies in vac-
cinated animals protected from exposure to inhalational anthrax, there is strong evi-
dence that the vaccine protects humans against inhalational anthrax.
In the 1980s, an Advisory Review Panel was established to review information on
biologic products licensed prior to July, 1972. In 1985 this panel recommended con-
tinuation of the anthrax vaccine based on substantial evidence of safety and efficacy.
This review included a CDC-sponsored vaccine safety study, in which approximately
16,000 doses of vaccine were administered according to the current six-dose schedule
to approximately 7,000 study participants from 1967 to 1971. The panel also re-
viewed surveillance efficacy data collected by the CDC between 1962 and 1974. Dur-
ing this period, 27 cases of anthrax were identified in employees working in or near
goat hair mills. Twenty four of these employees were unvaccinated and the remain-
ing three had received only one or two doses of the anthrax vaccine. These two stud-
ies, in addition to the efficacy data from the Brachman study, served as the basis
for the panels recommendation. No anthrax cases have been reported in fully vac-
cinated persons. Since the availability of the current vaccine, the occurrence of an-
thrax in at risk industrial settings, including laboratory workers, has been nearly
eliminated.
Demonstration of immune response.Human immune response studies were re-
cently performed by Dr. Phillip Pittman and co-workers, using an assay which
measured the development of antibodies specific for B. anthracis Protective Antigen
(PA) known to be important to protection. In 28 volunteers immunized according to
the current schedule of subcutaneous injections, (0, 2, and 4 weeks), significant im-
mune responses (i.e. seroconversion) were detected in almost all of the recipients
after two doses of vaccine, and in all persons after three doses. Other volunteers
received vaccine at 0 and 4 weeks only, one group by the subcutaneous route (n=23)
and one by the intra-muscular route (n=22). Except for one individual in the intra-
muscular group, all volunteers tested were found to have seroconverted after the
second (4-week) dose. The size of this study was not considered large enough to sup-
port a change in the dosing schedule or the route of administration.
Demonstration of protection.Because it would be unethical to challenge immu-
nized persons with B. anthracis, such studies must be performed in animals.
Nonhuman primates, which develop inhalational anthrax much like that seen in hu-
mans, have been used extensively. A total of 65 non-human primates, immunized
with only one or two doses of anthrax vaccine, have been given inhalation chal-
lenges containing hundreds of times the number of anthrax spores known to be le-
thal in unvaccinated animals. Of these, 62 animals (95 percent) survived the chal-
lenges. When eight of the non-human primates received a high-dose inhalation chal-
lenge two years after they received two doses of the vaccine, seven survived, indi-
cating long-term immunity.
Similar anthrax inhalation challenges were performed in rabbits, which also de-
velop inhalational anthrax similar to that seen in non-human primates and in hu-
mans. Of 117 rabbits challenged following two doses of vaccine, 114 (97 percent) sur-
vived.
Dr. Arthur Friedlander and co-workers performed a post-exposure study in
nonhuman primates, some of which had also received a 30-day course of antibiotics.
The group of animals that received both vaccine and antibiotics following inhalation
exposure remained free of disease throughout, and long after, the 30-day period of
antibiotic treatment. Furthermore, this was the only group of animals that survived
a second inhalation exposure -indicating that they had developed immunity against
the anthrax.
The above series of studies of the anthrax vaccine illustrate several ways to over-
come the inherent difficulty in demonstrating the efficacy of vaccines to be used for
defense against bio-terrorism and bio-warfare agents. Since natural exposure to
many of these agents does not exist, and because human challenge studies would
be considered unethical, straightforward efficacy studies cannot be performed. In-
stead, a careful assessment of the immune responses following vaccination in hu-
128
mans, as well as evaluations of protection against infectious challenges in relevant
animal models, must be made.
The currently licensed schedule of subcutaneous injections given over 18 months,
will soon be evaluated in a large CDC-sponsored study. Along with evaluations of
the safety of the vaccine, the impact of reductions in the number of doses adminis-
tered, as well as the route of administration (subcutaneous v. intra-muscular), on
the immune response to B. anthracis will be determined. These immune responses
will be compared to those seen in a parallel study involving non-human primates,
which will later be subjected to inhalational challenges with anthrax. Through these
studies, a deeper understanding of the immune correlates of protection will be
achieved, and the most appropriate dosing schedules determined.
The Advisory Committee on Immunization Practices (ACIP) has recently rec-
ommended that in a confirmed post-exposure setting, where anthrax vaccine is
available, antibiotic prophylaxis should continue for 4 weeks and until three doses
of vaccine have been administered. The consensus that three doses are expected to
provide significant protection is justified in the context of the most current medical
information available. This includes the known human immune response data and,
the above-mentioned, long-term protection seen in non-human primates following
only one or two doses.
Our present understanding of the immune system, coupled with the findings of
these animal and human studies lead to a reasonable expectation that the anthrax
vaccine should be protective after two or three doses. The challenge is to conclu-
sively demonstrate this when direct efficacy studies in humans cannot be under-
taken. This challenge applies not only to the current anthrax vaccine, but also to
any anthrax vaccine now under development.
Myth.BioPort has failed to produce anthrax vaccine since acquiring the facility
from the State of Michigan.
Fact.Contrary to news reports, BioPort has maintained and significantly added
to a stockpile of anthrax vaccine since acquiring the facilities in Lansing, Michigan,
three years ago. Although we cannot discuss the specific numbers contained in that
stockpile, there is now a considerable amount of anthrax vaccine that could be made
immediately available in an emergency, if fully supported by the FDA. It requires
coordination, decisionmaking and action across three Federal agencies:
The Department of Defense, which owns the vaccine;
The Department of Health and Human Services, which based on the advise of
the medical experts in the CDC, would recommend its use; and
The FDA, which would authorize the release of the vaccine.
Further, we stand ready to manufacture the licensed anthrax vaccine to full ca-
pacity in our renovated facilities. We have met regularly with representatives from
each of these agencies to discuss this considerable stockpile and to offer our full as-
sistance and support in the event that vaccine is needed on an emergency basis.
Myth.BioPort has been mismanaged since acquiring the facilities from the State
of Michigan.
Fact.There is now and there has for some time been a capable management
team in place. We have been successful in hiring industry-experienced managers
and technical experts. The company culture has been transformed from that of a
state bureaucracy to a results-oriented business. For the last two years, we have
been meeting regularly with the FDA to update our progress. The relationship with
FDA is constructive and the agency has expeditiously reviewed the various seg-
ments of our submission. We are also working closely with our partner, the Depart-
ment of Defense. In short, we have the right people, in the right places, doing the
right things to get this job done.
On the financial side, when BioPort took over the vaccine manufacturing facilities
from the State of Michigan we were well aware that we were taking over an unprof-
itable venture with an aging physical plant that had never been operated in a com-
mercial environment. The State had no effective financial accounting system in
place for tracking costs. To meet the heightened FDA biological product regulatory
standards, a company in this business must have substantial quality control sys-
tems, which takes considerable time and expense to put in place. Unfortunately, the
States management practices did not include calculation of these costs. There was
no direct relationship between Michigans total costs of producing the anthrax vac-
cine and the prices paid by the Department of Defense. It became clear to us that
the prices paid to Michigan by the government for the vaccine were significantly
below the costs for producing the vaccine under modern regulatory standards. Au-
dits which were conducted by the Department of Defense, supported an adjustment
to the contract price of the vaccine.
Furthermore, in the last two years, there have been five major financial audits
by the Defense Contract Audit Agency (DCAA). BioPort has submitted over 50 fi-
129
nancial reports during this time. Our compliance with contract accounting stand-
ards has been consistently confirmed by these audits.
In addition to these accounting audits there was a widely reported criminal inves-
tigation conducted by the Defense Investigative Services (DIS). What has not been
reported is the fact that we were completely cleared of any wrongdoing. A recent
DIS letter confirms that fact.
The funding from the DOD in the last three years has been substantial and
BioPort is grateful for the departments continued support. But these expenditures
need to be placed in the overall perspective of the industrial costs of vaccine devel-
opment and manufacture. DODs investment in BioPort over the past three years
is the most cost-effective investment that any agency in the federal government is
committing to insure the availability of the needed defense or civilian vaccines.
DODs own report on the costs for vaccine research, development and manufacturing
estimates that it will require an average of $400 million over a 5- to 10-year period
for each FDA-licensed vaccine. Another vaccine company, Aviron has reported that
they will have expended between $400 to $500 million over many years in devel-
oping and manufacturing their intranasal flu vaccine. They are still awaiting their
FDA license. The government has indicated that it will take several billion dollars
and many years for other defense vaccines to be developed and manufactured. An
October 2000 independent report by the Institute for Defense Analysis (IDA) con-
cluded that the fastest route to a continued supply of licensed anthrax vaccine is
through BioPort. Now a year since that report, its findings are still valid.
FUTURE CONSIDERATIONS
Allow me to make a few final points. As you, our nations policymakers, look to
the future for a viable long-term vaccine program, several issues must be resolved.
Important among these are:
The oversight and management of the development and manufacture of defense
vaccines must be streamlined, becoming less bureaucratic. The creation of a cabinet
level position and the appointment of Governor Ridge to that position are encour-
aging early steps.
The dollars committed to protection against biological threats need to better
match the nations goals. Facing the potential of a cost of $400 million per vaccine
developed, the financial commitments now being pledged by Congress will better en-
able the goals to be met.
There must be adequate incentives to assure the engagement of the private sector
to meet these goals. We are aware that several bills are being drafted to specifically
address this point and firmly believe that incentives will be adequately considered.
In addition to these incentives, some form of protection from tort is needed for
defense vaccines use in the civilian sector as it is for several products supplied to
the DOD.
Just as important, misinformation must be corrected vigorously as soon as it sur-
faces. As has been clearly demonstrated for anthrax vaccine, left unanswered, misin-
formation erodes confidence and progress in defense vaccine development and manu-
facture. It must be countered whenever it occurs.
Once again, thank you for this opportunity. I am eager to respond to your ques-
tions.
Senator HARKIN. Next is Mary Kuhn, head of operations for
Bayer Corporation.
STATEMENT OF MARY KUHN, VICE PRESIDENT OF OPERATIONS,
BAYER CORPORATION
Ms. KUHN. Thank you, Senator Harkin, Senator Specter, and
other distinguished members of this Senate appropriations sub-
committee. My name is Mary Kuhn, and I am head of operations
for the Bayer Corporation Pharmaceutical Division in Westhaven,
Connecticut. The core objective of Bayer Pharmaceutical is to sig-
nificantly improve health worldwide. Since the events of September
11 and the days that have followed, we stand even more committed
to that purpose. We at Bayer Corporation would like to assure Con-
gress that we will meet the Nations demands for Cipro, our anti-
biotic, which has FDA approval for post-inhalation anthrax.
130
The issue that looms large with this subcommittee and, of course,
with the American public is, can Bayer fulfill our Nations Cipro re-
quirements? The answer to that question is yes. Please allow me
to elaborate.
Bayer is currently producing Cipro at an incredibly rapid and un-
precedented rate, over 2 million tablets each and every day. We
continue to work closely with the Centers for Disease Control and
the Department of Health and Human Services to make available
this key weapon in the fight against anthrax. Bayers U.S. facilities
shipped more than 50 million tablets of Cipro in the month begin-
ning September 16 through October 16. In response to the in-
creased demand, Bayer has tripled its production of Cipro.
Prior to the terrorist attacks, typical production of Cipro was
about 20 million tablets per month. We have now committed to
supplying 200 million tablets over the next 3 months. That is more
than 15 million tablets a week. In addition, because of Bayers glob-
al resources, we will be able to supply additional Cipro tablets.
In order to manufacture this quantity, Bayer is now running its
Connecticut Cipro production facilities on an expanded production
schedule. We are also reopening an additional manufacturing plant
to augment active ingredient stock. We are sending shipments of
Cipro out every day of the week, including Saturdays and Sundays.
We believe that with current inventories, plus the amount we are
now supplying, in conjunction with other FDA-approved drugs such
as doxycycline, there will be enough Cipro in Government phar-
macies and other facilities to treat over 12 million Americans for
anthrax, the objective recently set by the Department of Health
and Human Services.
In addition, Bayer does support the Food & Drug Administra-
tions approval of doxycycline for the treatment of all forms of an-
thrax, including inhalation anthrax. These drugs are widely avail-
able from a variety of generic manufacturers. We are confident that
there should be no concerns about an adequate supply of safe and
effective treatments for anthrax. We feel it is important for this
subcommittee to realize that Bayer has fulfilled every order from
the United States Government within the requested delivery sched-
ule.
We continue to work daily with the Government to define and
fulfill future orders. To our knowledge, everyone who has needed
Cipro in response to an anthrax event has been able to get Cipro.
Soldiers going overseas carry Cipro. The people in New York, Flor-
ida, New Jersey and Washington who have been exposed to an-
thrax have had Cipro prescribed and have been able to procure it.
The CDC, which is in charge of stockpiling the drug, has ordered
millions of tablets. These orders have been filled completely, and
the agency has them in their inventory. We are working closely
with the Nations drug distribution system to get Cipro to those
locales and to those people who are most immediately in need of
it.
Our confidence in the adequacy of antibiotic supplies to treat an-
thrax is further enhanced by the efforts of Secretary Thompson,
Surgeon General Satcher, and countless other Government and
non-Government authorities. These leaders are advising the public
of the harm that could be caused by taking antibiotics just in case,
131
and to warn people against hoarding drugs through advertising

and other initiatives, such as this one in todays paper. Bayer is
adding its voice to ensure that these critical messages are under-
stood and followed.
To address any concerns that we will not be able to meet this
commitment, we would like to point out that this is not the first
time that we have had to respond quickly in a national emergency.
During the Persian Gulf War, we were called upon by the Depart-
ment of Defense to supply 45 million Cipro tablets for air and
ground troops. Bayer met these urgent production and delivery tar-
gets.
The support of Secretary Thompson, Surgeon General Satcher
and others in their educational efforts regarding appropriate use,
personal stockpiling, and the wide availability of generic treatment
alternatives will help to manage the demand for Cipro in phar-
macies throughout the country.
Bayer fully recognizes that it has a compelling responsibility to
assist the Nation in addressing bioterrorist threats. We are proud
to have a role in this effort to confront this national emergency and
protect the health of the American public. We have fulfilled that
role in the past, and we continue to do that today.
PREPARED STATEMENT
There is no doubt that comprehensive coordination between rel-

evant branches of Government and the pharmaceutical industry is
absolutely critical to addressing bioterrorist threats. We urge this
subcommittee to do all in its powers to assure this coordination and
cooperation continues. We will face this latest challenge together,
and we will succeed.
PREPARED STATEMENT OF MARY KUN
Chairman Harkin, Senator Specter and other distinguished members of this Sen-
ate Appropriations subcommittee, my name is Mary Kuhn, and I am the Head of
Operations for the Bayer Corporation Pharmaceutical Division in West Haven, Con-
necticut.
The core objective of Bayer Pharmaceutical is to significantly improve health
worldwide. Since the events of September 11 and the days that have followed, we
stand even more committed to that purpose. We at Bayer Corporation would like
to assure Congress that we will meet the nations demands for Cipro, our antibiotic
which has FDA approval for post-inhalation anthrax.
The issue that looms large with this subcommittee and of course with the Amer-
ican public is: Can Bayer fulfill our nations CIPRO requirements?
The answer is yes.
Please allow me to elaborate:
Bayer is currently producing Cipro at an incredibly rapid and unprecedented
rate . . . over 2 million tablets each and every day. We continue to work closely
with the Centers for Disease Control and the Department of Health and Human
Services to make available this key weapon in the fight against anthrax.
Bayer US facilities shipped more than 50 million tablets of Cipro in the month
beginning September 16 to October 16.
In response to the increased demand, Bayer has tripled its production of Cipro.
Prior to the bioterrorism attacks, typical production of Cipro was 20 million tab-
lets per month. We have now committed to supplying 200 million tablets over
the next three monthsthats more than 15 million tablets a week.
In addition, because of Bayers global resources we will be able supply addi-
tional CIPRO tablets
In order to manufacture this quantity Bayer is now running its Connecticut Cipro
production facilities on an expanded production schedule. We are also reopening an
132
additional manufacturing plant to augment active ingredient stock. We are sending
shipments of Cipro out every day of the week, including Saturdays and Sundays.
We believe that with current inventories plus the amount we are now supplying,
in conjunction with other FDA approved drugs such as doxycycline, there will be
enough Cipro in government, pharmacy and other facilities to treat over 12 million
Americans for anthrax, the objective recently set by the Department of Health and
Human Services.
In addition, Bayer supports the Food and Drug Administrations approval of
doxycycline for the treatment of all forms of anthrax, including inhalation anthrax.
These drugs are widely available from a variety of generic manufacturers. We are
confident that there should be no concerns about an adequate supply of safe and
effective treatments for anthrax.
We feel it is important for this subcommittee to realize that Bayer has fulfilled
every order from the United States government within the requested delivery sched-
ule. We continue to work daily with the government to define and fulfill future or-
ders. To our knowledge, everyone who has needed Cipro in response to an anthrax
event, has been able to get Cipro. Soldiers going overseas carry Cipro. The people
in New York, Florida, New Jersey and Washington who have been exposed to an-
thrax have had Cipro prescribed and have been able to procure it. The CDC, which
is in charge of stockpiling the drug, has ordered millions of tablets. The orders have
been filled completely and the agency has them in their inventory. We are working
closely with the nations drug distribution system to get Cipro to those locales, and
to those people who are most immediately in need of it.
Our confidence in the adequacy of antibiotic supplies to treat anthrax is further
enhanced by the efforts of Secretary Thompson, Surgeon General Satcher and count-
less other government and non-government health authorities. These leaders are ad-
vising the public of the harm that could be caused by taking antibiotics just in
case, and to warn people against hoarding drugs. Through advertising and other
initiatives, such as this one in todays newspaper, Bayer is adding its voice to ensure
that these critical messages are understood and followed.
To address any concerns that we will not be able to meet this commitment, we
would like to point out that this is not the first time we have responded quickly
in a national emergency. During the Persian Gulf War we were called upon by the
Department of Defense to supply 45 million Cipro tablets for air and ground troops.
Bayer met these urgent production and delivery targets.
The support of Secretary Thompson, Surgeon General Satcher and others in their
educational efforts regarding appropriate use, personal stockpiling, and the wide
availability of generic treatment alternatives will help to manage the demand for
Cipro in pharmacies throughout the country.
Bayer fully recognizes that it has a compelling responsibility to assist the nation
in addressing bioterrorist threats. We are proud to have a role in the effort to con-
front this national emergency and protect the health of the American public. We
have fulfilled that role in the past and we continue to do that today. There is no
doubt that comprehensive coordination between relevant branches of government
and the pharmaceutical industry is absolutely critical to addressing bioterrorist
threats. We urge this subcommittee to do all in its powers to assure that this coordi-
nation and cooperation continues.
We will face this latest challenge together and we will succeed.
Senator HARKIN. Thank you, Ms. Kuhn. Now I would just like to
recognize Senator Reid for the purpose of an introduction of our
next witness.
Senator REID. Senator Harkin, Senator Specter, I apologize for
being late, but I have literally been on the floor since we last
spoke. Typically, let me just say that this hearing is very impor-
tant, like all those you have done on stem cells, diabetes, and I
could go on and on.
Senator SPECTER. Go ahead, Senator Reid.
Senator REID. I appreciate this hearing, but I want to take just
a minute to introduce Barbara Lee Hunt, who is the Washoe Coun-
ty Health District Health Officer. Washoe County is, we know, the
second most populous county in the State of Nevada. She has cer-
tainly been in the trenches.
133
As you know, Reno was deemed to have an anthrax problem 2

weeks ago, or 3 weeks ago, and as a result of the work that was
done in Reno, by Barbara Hunt, and all the screening she super-
vised, she is qualified and very important to speak to what we are
trying to determine here in this committee, and it is a pleasure to
introduce Barbara Hunt to this committee.
Senator HARKIN. Thank you very much, Senator Reid. Ms. Hunt,
welcome to the committee. Please proceed.
STATEMENT OF BARBARA HUNT, R.N., M.P.A., DISTRICT HEALTH OFFI-
CER, WASHOE COUNTY HEALTH DEPARTMENT, RENO, NEVADA
Ms. HUNT. Good morning, Mr. Chairman, Senator Specter, and
members of this subcommittee. I am Barbara Lee Hunt, District
Health Officer for Washoe County. I was asked to present a little
bit of our experience in Reno a couple of weeks ago, and I will try
to do that as briefly as possible.
I think a key point is that when it became public that a sus-
picious letter that was delivered to Microsoft in Reno had tested
presumptively positive for the bacillus anthracis, both health de-
partments, Clark Health Department in Las Vegas and our depart-
ment in Reno, and our Reno 911 dispatch centers were inundated
with calls from concerned citizens, hospitals, law enforcement, and
physicians offices, to the point that the State Emergency Oper-
ations Center had to be activated to help take calls.
The District Health Department in Reno appropriately took the
lead in the public health investigation and the overall response. We
identified, interviewed, and collected specimens for testing from six
people who had contact with the letter. We did personal and envi-
ronmental risk assessment, and made appropriate recommenda-
tions. We coordinated with the hospitals, law enforcement, and
emergency medical responders, and we were the local information
source.
What went well was the State Emergency Operations Center. It
took calls for the entire State for 3 days. The Health Alert Network
worked well in sending us updates on anthrax and related issues
on a regular basis.
We managed to prevent further strain on public health and safe-
ty systems by educating the public with frequent, consistent, and
coordinated communications through the media and by other
means. We provided intensive on-site education for hundreds of
employees in the Sierra Pacific Power Building where Microsoft is
located.
We were in constant communication with Microsoft and the Si-
erra Pacific Power management, forging relationships that resulted
in support for our recommendations. Despite some pressure from
offices and the advice of medical consultants that conflicted with
our recommendations, they even participated in all of our press
conferences.
What did not go quite so well is that the initial publicity placed
us in a reactive position for a few hours, which contributed to
delays in communication and coordination with health and public
safety agencies and delayed the establishment of telephone hot-
lines. This contributed to an initial overloading of the ambulance
and 911 dispatch systems. Hospital emergency rooms were flooded
134
with the worried well. It took quite a while to get definitive labora-
tory results.
What we learned was that we can handle small, contained
events. A larger event, especially a covert attack with a disease
agent that is transmissible person-to-person would overwhelm not
only the public health system but our hospitals and public safety
systems, and emergency medical responders as well.
What we have identified as needs to improve our response capa-
bilities include increased public health laboratory staff, equipment,
and training for more rapid assessment of biological threat agents.
A great deal of public concern could have been avoided if we had
been able to obtain definitive laboratory results sooner. In Nevada,
we also need another location for our public health laboratory.
There is one location in the entire State. That is in Reno. Las
Vegas needs a public health laboratory.
As we know across the country, not only public health practi-
tioners but physicians, hospitals, and emergency responders all
need training in bioterrorism and how to respond to it. We found
a situation where a local official advised Sierra Pacific Power not
to bring their employees together for an educational meeting about
anthrax because they thought it would be risky.
Additional epidemiology staff for the State and local health de-
partments is extremely important. We must increase our capacity
to conduct public health investigations and surveillance, and par-
ticularly to heighten surveillance during high profile events that
are so common in Las Vegas and Nevada, and that bring so many
tourists from all over the world, not to mention all over the coun-
try. We need a bioterrorism coordinator to coordinate training and
preparation not only in-house, but coordinate training and prepara-
tion with the community, the hospitals, public safety, and emer-
gency responders.
We found that something very important to have was a public in-
formation officer to coordinate communication with the public. The
health department needs such a public information officer. If
Washoe County had not generously loaned us their entire public
education staff we would have had much greater public concern
and a greater strain on health and public safety resources.
Our key objective was to avoid the kind of panic that had people
flooding the 911 system and the hospital emergency rooms. We
need good data systems at Washoe County District Health Depart-
ment. We need a full-time physician. We do not have a physician
on staff. We have a medical consultant who has other full-time em-
ployment.
Hospital capacity is an issue, particularly in Las Vegas. An ordi-
nary flu season can overwhelm the hospitals.
PREPARED STATEMENT
I would like to thank you very much for your support of public
health, and to urge that full funding be allocated for the public
health threats and emergencies. Thank you.
135
PREPARED STATEMENT OF BARBARA LEE HUNT
Good morning, Mr. Chairman and members of the Subcommittee, I am Barbara
Lee Hunt, District Health Officer for the Washoe County District Health Depart-
ment, serving Reno, Sparks and Washoe County, Nevada.
BACKGROUND
The only other local health district in Nevada is Clark County Health District,
serving Las Vegas. Five hundred miles separate Reno and Las Vegas. The State
Health Division serves the remaining 15 rural counties.
We host many high profile events that draw thousands of tourists from all over
the world, creating attractive terrorist targets. Depending on the agent used, a bio-
terrorist attack in Reno or Las Vegas could have national and international impacts.
WHAT HAPPENED
When it became public that a suspicious letter delivered to Microsoft in Reno had
tested presumptively positive for Bacillus anthracis, both health districts and Renos
911 dispatch center were inundated with calls from concerned citizens, physicians
offices, law enforcement, and hospital emergency rooms. The State Emergency Oper-
ations Center even had to be activated to assist with calls.
The District Health Department appropriately took the lead in the public health
investigation and overall response. We identified, interviewed and collected speci-
mens for testing from 6 people whod had contact with the letter. We did personal
and environmental risk assessment and made appropriate recommendations. We co-
ordinated with hospitals, law enforcement and emergency medical responders. We
were the local information source.
WHAT WENT WELL
The State Emergency Operations Center worked well, taking calls for 3 days. The
Health Alert Network worked well.
We prevented further strain on the public health and safety systems by educating
the public with frequent, consistent and coordinated communication through the
media. We provided intensive, onsite education for hundreds of employees in the Si-
erra Pacific Power building, where Microsoft is located.
We were in constant communication with Microsoft and Sierra Pacific Power man-
agement, forging relationships that resulted in support for our recommendations,
despite pressure from their corporate offices and advice from their medical and envi-
ronmental consultants that conflicted with our advice. They even participated in all
our press conferences.
WHAT DID NOT GO WELL
Initial publicity placed us in a reactive position for several hours, contributing to

delays in communication and coordination with health and public safety agencies
and delaying establishment of hotlines. This contributed to initial overloading of the
ambulance and 911 dispatch systems. Hospital emergency rooms were flooded with
worried well. Definitive laboratory results took a week.
WHAT WE LEARNED
We learned that we can handle small, contained events. A larger event, especially
a covert attack with a disease transmissible from person to person, would over-
whelm our public health and safety systems, hospitals and emergency medical re-
sponders.
What we need to improve our response capabilities are:
Increased public health laboratory staff, equipment and training for more rapid
assessment of biological threat agents. A great deal of public concern could have
been avoided if we had been able to obtain a definitive result sooner.
Trainingfew of our staff have had any level of bioterrorism training, and were
not alone. A physician advised Sierra Pacific Power not to bring their employees
together for a meeting, advising that it would be risky to have them in the same
room.
Additional epidemiology staff for the state and both local health departments.
We must increase our capacity to conduct public health surveillance and epide-
miological investigations and heighten surveillance during high profile events.
A bioterrorism coordinator for each local health district and the state, to coordi-
nate training and preparation in house and with our hospitals, public safety
and emergency medical responders.
136
A health department public information officer to coordinate communication
with the public. Without the loan of public information staff from Washoe Coun-
ty, we would have had increased public concern and greater strain on health
and public safety resources.
A physicianwe do not have a physician on staff. We have a medical consultant
who has other fulltime employment.
Hospital capacity to handle a sudden surge of patients.
In addition, our disaster planning must include biological scenarios and realistic
simulation exercises.
All of these resources would serve us in day to day public health work and in
emergencies, such as emerging infectious diseases, communicable disease outbreaks,
toxic spills, and natural disasters.
The Kennedy-Frist bill proposes appropriate initial funding for state and local
public health preparedness and response to bioterrorism. I ask that you support it.
Thank you.
Senator HARKIN. Thank you for being here. That is why I think
we have more money in our bill for this.
I would recognize Senator Specter for purposes of an introduc-
tion.
Senator SPECTER. Thank you, Mr. Chairman. Just a word or two
about our next witness, Dr. Hilary Koprowski, one of the worlds
greatest scientists since he received his M.D. degree from the Uni-
versity of Warsaw in Poland in 1939, and that puts you on the
record for 62 years of active work, Dr. Koprowski.
Among his many accomplishments involve his contribution to the
development of the first live polio vaccine. I would not want to use
his full 5 minutes by describing all of his honors or positions which
he holds.
STATEMENT OF HILARY KOPROWSKI, M.D., PRESIDENT, BIO-
TECHNOLOGY FOUNDATION, INC., PHILADELPHIA, PA, PRO-
FESSOR, DEPARTMENT OF MICROBIOLOGY AND IMMUNOLOGY,
DIRECTOR, CENTER OF NEUROVIROLOGY AND BIOTECHNOLOGY
FOUNDATION LABORATORIES AT THOMAS JEFFERSON UNIVER-
SITY
Dr. KOPROWSKI. Thank you, Senator Specter. Mr. Chairman, I
am Director of the Biotechnology Foundation of Thomas Jefferson
University, Pennsylvania, and head of the Microbiology Institute.
As Senator Specter said, I have developed the first oral polio vac-
cine that led to the first mass trial with oral polio vaccine, and this
bridged the way to eradicate polio from the world in 2004.
For the past 10 years, I have led a team of scientists to study
plants as vectors for the production of vaccines and other
biomedicals, and our studies of the virus B vaccine was found to
create protection of hepatitis, the vaccine which we grew in spinach
and fed to human volunteers.
We have successfully in the laboratory created the experimental
vaccine in tobacco plants against AIDS. We have both the knowl-
edge and techniques to produce any vaccine, whether it be bacteria
or whether it be viral, like smallpox or any other thing, in plants
using two techniques. We transform plants whose foreign agents
produce vaccines either in seeds, leaves, or fruit. Such plants can
be provided indefinitely as a source of vaccine production.
Another approach is we use plant viruses to fuel these foreign
agents. Plants were infected with these compounds, and they were
isolated in plant virus and the foreign agent to produce vaccine.
137
As far as the anthrax vaccine project, for several years we have

proposed this anthrax project which we thought might be of inter-
est to the military. The project is aimed at developing safe, cost-
effective vaccine which could be used for mass oral vaccinations.
Our immediate goal of this project is to stabilize the protective
antigen of anthrax, the fusion of the plant protein, and then trans-
formations of lettuce and radishes.
Laboratory animals will be fed with raw plants which have been
transformed and then tested for resistance at Fort Dietrick. In ad-
dition, the transformed plant material will be processed to produce
tablets containing the antigen and the vaccines in trials. Clinical
trials in man can follow immediately the experimental procedure,
which we are dealing with plants, not with animal tissue. This we
can process in a safe way, and you have no cross-contaminants
which can be produced in animal tissue.
Now, within a year of founding the project, we could start prop-
erly having clinical trials. Now, the advantages of this, no cross-
contamination, it does not require sophisticated and expensive fa-
cilities. Four pounds of specific protein can be recovered from an
acre of plants. It can be grown in different geographical and cli-
mactic conditions, and it can be used as a vehicle for oral delivery
of vaccine.
PREPARED STATEMENT
So this is what I would like to say in our proposal today, that

we have done something already with anthrax, and this is, we took
three or four domains of the protective antigen and fuse it with a
plant virus and then infect it with a plant virus in tobacco plants,
and if funds would be available we can check whether it produces
immunity. This is just to tell you that there is feasibility in this
project and it can be applied to almost every biomedical in the
world.
Thank you very much.
PREPARED STATEMENT OF HILARY KOPROWSKI
My name is Hilary Koprowski. I am presently the Director of the Biotechnology
Foundation located at Thomas Jefferson University, Head of the Center of
Neurovirology and Professor of Microbiology and Immunology also at Thomas Jeffer-
son University in Philadelphia, Pennsylvania.
To tell you a little bit about myself, I developed the first oral polio vaccine and
conducted the first mass trial immunization by oral route with polio vaccine. This
bridged the way for a plan to eradicate polio from the world in 2004.
For the past 10 years I led a team of scientists to study plants as vehicles for
the production of vaccines and other biomedicals. In our studies, Hepatitis B vac-
cine, grown in lettuce was administered to human volunteers by feeding and was
found to produce antibodies against Hepatitis virus. Rabies vaccine, which we grew
in spinach and fed to human volunteers led to immune reactivity to rabies. We have
successfully created an experimental vaccine in tobacco plants against AIDS.
We have both the knowledge and the techniques to produce any vaccine in plants
using two techniques to achieve our goals:
(1) We transformed plants with foreign agents to produce vaccines either in seeds,
leaves or fruit. Such plants can propagate indefinitely as a source of vaccine produc-
tion.
(2) In the other approach, we used plant viruses to fuse with foreign agents.
Plants were infected with these compounds and we isolated the plant virus and the
foreign agent to produce the vaccine.
138
ANTHRAX VACCINE PROJECT
For several years we have proposed this Anthrax project, which we thought might
be of interest to the military. The project is aimed to develop a new, safe, cost-effec-
tive vaccine which could be used for mass oral vaccination against anthrax. Our im-
mediate goal of this project is to stabilize the Anthrax Protective Antigen (Pa)
through fusion with the stable plant protein called ubiquitin and to use this recom-
binant for transformation of lettuce and radishes. Laboratory animals will be fed
raw plants which have been transformed by Pa and then tested for resistance to
infection at Fort Dietrich. In addition, the transformed plant material will be proc-
essed to produce tablets containing the Pa antigen and these, in turn, will be tested
for immunogenic potential. Clinical trials in man will follow the successful outcome
of laboratory investigation within a year after funding for the project is made avail-
able. The great advantages of plant-derived vaccines are as follows:
Safety.No cross contamination
Inexpensive.Does not require sophisticated and expensive facilities; Up to 4
pounds of specific protein can be recovered from an acre of plants.
Distribution.Can be grown in different geographical and climactic conditions;
can be produced locally.
Delivery.Can be used as a vehicle for oral delivery of vaccines.
Continuous production.Once transgenic lettuce and radishes become available
they can be propagated ad infinitum as a source of anthrax vaccine.
PROGRESS UP TO DATE
In preliminary experiments, we succeeded in the expression (in tobacco plants) of

three fragments of anthrax protective antigen (Domains 1, 4 and part of 4) fused
with a plant virus in tobacco plants. Virus particles obtained from plant extracts
were purified and are ready to be checked for their immunogenicity in animals
when funds become available. We are ready to proceed! We are just waiting for
funding and the go ahead.
Senator HARKIN. That is fascinating. We will follow up on that
one. Thank you, Dr. Koprowski.
Now let us move to Thomas Monath, vice president for research
and medical affairs for Acambis, makers of smallpox vaccine.
STATEMENT OF THOMAS P. MONATH, M.D., VICE PRESIDENT FOR RE-
SEARCH AND MEDICAL AFFAIRS, ACAMBIA, INC.
Dr. MONATH. Mr. Chairman, members of the subcommittee,
thank you for the opportunity to speak today about smallpox vac-
cine and the threat of bioterrorism.
As mentioned, I represent a company called Acambis, a publicly
traded company headquartered in the United Kingdom. Our vac-
cine program is performed solely in the United States, by our divi-
sion in Massachusetts. I also spent 20 years of my life with the
CDC, and I have a perspective on the use of vaccines from a public
perspective as well.
As you know, smallpox vaccination has been performed for over
200 years. The market, however, for this vaccine collapsed after
eradication of the disease in the late 1970s. The last vaccine made
in the United States by Wyeth was in 1982. This was a crude vac-
cine, made in the way that it had been for 2 centuries, collecting
serum from the skin of cows and processing that into a vaccine.
That is not a modern way to make a vaccine, so it is really not fea-
sible to go back to that method of preparing a new product.
Now, the last administration became concerned about bioter-
rorism and the threat of smallpox, and that led to a contract
awarded to our company about a year ago, September 2000, to
produce about a 40 million-dose stockpile of new, modern smallpox
vaccine, using cell culture techniques. Our goal was to prepare a
vaccine that matched as closely as possible the biological character-
139
istics of the original vaccine, since it was unlikely we could actually

demonstrate efficacy, since the disease had disappeared.
We were successful in the first few months of this program. Our
scientists created a new vaccine with those properties, and the re-
maining time since the award has been devoted to making the vac-
cine in a way that the Food and Drug Administration would find
acceptable for a new human product, and we are almost there. We
plan to begin clinical trials of the new vaccine in January of next
year.
Now, the original contract I mentioned was for 40 million doses,
and the world has obviously changed. We got a change order to our
contract recently to increase it to about 54 million doses, and to ac-
celerate the program. As was mentioned here already, the Govern-
ment and HHS has determined that they should afford the Amer-
ican people one dose per person, roughly 300 million doses of vac-
cine, and we are currently responding to a request for information
from HHS to greatly increase and accelerate the amount of vaccine
that our company could provide.
We teamed up with Baxter Health Care, a big U.S. pharma-
ceutical company, in order to achieve this. Baxter owns a signifi-
cant equity share in our company. We have a strong collaboration
with them on many fronts. It is our belief we could manufacture
the amount of vaccine that the Government has requested in about
the first 9 months of 2002. We are looking at the cost of doing this.
We are not sure that the estimate that has been mentioned today
of $509 million is going to cover such an effort. We will know more
in the next day or so.
I want to also make the committee aware that in addition to the
vaccine, we have to think about distributing the vaccine. The art
of how you perform vaccinations is a lost art, and people need
training in order to do this.
There are two other matters which I feel important to bring to
the subcommittees attention. The first is that what we are doing
is unheard of in the history of vaccine development. The normal
cycle of development of a new vaccine is roughly 10 years, and it
is a very difficult proposition to get through all of the regulatory
hurdles and clinical trials and so on, so we are planning to do
something in record time.
A highly proactive collaboration with the Food and Drug Admin-
istration is absolutely critical to make things happen. This is not
going to be business as usual, but we have to make sure that no
short-cuts are taken, because the product must be of highest qual-
ity, since one can certainly imagine the situation in which a lot of
vaccine might be given when faced with a threat, only to find out
later that that was just a threat and nothing was actually hap-
pening. So we need a safe vaccine that meets all of FDA regula-
tions regarding product quality.
Second, I would like to make the point that vaccine manufactur-
ers, including us, require indemnification against tort claims re-
sulting from vaccine-associated adverse events. Dr. Koplan men-
tioned if the entire U.S. population were immunized with a new
vaccine, more than 40 percent or so having never been vaccinated
before, that we could expect 2,0003,000 adverse events, potentially
140
lethal events, so particularly where the threat is uncertain the

safety of a vaccine is imperative.
PREPARED STATEMENT
It is quite extraordinary, but we got this contract from CDC

based on our providing private insurance against claims against us
and the Government associated with any adverse events. In the
setting of providing 300 million doses of vaccine, there is no private
insurers willing to pick up that kind of risk. It must be done by
the Government, and at the present time, although it has been
talked about and there are efforts underway, we are unable to
make a proposal to the Government for a lot of new vaccine absent
assurances regarding the indemnification piece.
I thank you for allowing me to speak today.
PREPARED STATEMENT OF THOMAS P. MONATH
Senator Harkin, Senator Spector, members of the Committee, thank you for the
opportunity to speak about smallpox vaccine and the threat of bioterrorism. I rep-
resent a bio-pharmaceutical company, Acambis, which has a contract with the CDC
to develop, manufacture, store and distribute a new smallpox vaccine. Acambis is
a publicly traded company headquartered in the United Kingdom but, our vaccine
program is performed by the United States branch of the Company, located in, Mas-
sachusetts. I wish to inform the Committee that I have a financial interest in mat-
ters pertaining to smallpox vaccine, and my statements should be viewed accord-
ingly.
Smallpox is a truly horrific disease known from ancient times. Over 200 years
ago, a British surgeon, Edward Jenner, developed use of cowpox (a virus related to
smallpox) for vaccination. Vaccine was made by scarifying the skin of calves, and
serum and pus containing vaccine virus was harvested from the skin. This crude
way of making vaccine continued up to 1982. Vaccine manufacture ceased because
smallpox disappeared after an intensive eradication program in the 1970s. The pos-
sibility that smallpox would be re-introduced as a bio-weapon was not a sufficient
priority for governments, including the US, to maintain a manufacturing capability.
Worldwide supplies of old, calf-skin vaccine have dwindled to about 60 million doses,
of which 15 million reside in the United States.
Rising concern about bioterrorism during the Clinton administration, ledin
1999to an effort to protect the American people against the threat of epidemic dis-
ease. The first step, taken in July 1999 was to identify an appropriate bio-pharma-
ceutical company willing and able to perform the task. A formal RFP was issued
in February 2000, and the CDC contract was awarded in September 2000, at which
time our Company initiated work.
The vaccine is a live attenuated virus, which is introduced into the most super-
ficial layer of the skin using a needle using the so-called multiple puncture tech-
nique, unlike other vaccines which are inoculated under the skin using a syringe.
It is worth noting that the method of delivering vaccinia requires skill and experi-
ence lost by virtually all medical personnel in the US. Wide-scale use of smallpox
vaccine will require concurrent training of medical personnel in the art of vaccina-
tion.
After introduction of the virus into the skin, the vaccinia virus produces a limited
local infection, which typically results in formation of a single pock within 37 days.
There are two features of this process that are worth noting. First, the formation
of a visible pock rapid evidence of immunity that is obvious and reassuring to both
patient and physician. This is unique, since all other vaccines stimulate immunity
silently and require a blood test to determine if a take has occurred. The second
unique feature of the vaccine is that it can be applied up to 34 days after exposure
to smallpox virus and still .provide protection. Since smallpox virus is transmitted
only by patients who have overt signs of rash, and since contacts can be effectively
protected by vaccination up to several days after exposure to such patients, there
is a very real opportunity to interrupt the spread of the disease. The problem we
face is supply and distribution of sufficient vaccine to deal with a wide range of pos-
sible scenarios should a bioterrorist attack occur.
141
Our original contract with CDC was to produce 40 million doses of vaccine using
modern methods in cell culture rather than in calf skin.
Our program at Acambis has been devoted to the creation of a new vaccine that
matches the safety and effectiveness of the original vaccine. This was accomplished
by our scientists in the first few months of the program. The remaining time since
the contract award has been devoted to the manufacturing of vaccine that meets the
stringent requirements of the Food and Drug Administration. Vaccine manufac-
turing is being scaled up in our facility, to reach very high levels of production next
year.
Acambis, together with our partner Baxter HealthCare, is also responding to a re-
quest from the Government for a large number of vaccine doses beyond the scope
of the current contract. It is the Governments intent to make sufficient vaccine over
the next 12 months, i.e., approximately 300 million doses, to provide for universal
coverage of the American people in case of an emergency or a decision to reinstitute
routine immunization.
I would like to take this opportunity to make two comments about this accelerated
program. First, the Committee should note that what is being tasked is highly un-
usual, indeed unheard of in the history of vaccine development. The cycle of develop-
ment from the initial stages through FDA licensure of a new vaccine typically takes
10 years, despite the best efforts on the part of industry to minimize timelines. A
highly proactive collaboration between industry and the FDA will be required to
achieve the Governments objective. However it is critical that shortcuts do not com-
promise product quality or demonstration of safety and effectiveness in clinical
trials, since is easy to imagine a situation where large numbers of individuals are
exposed unnecessarily to the vaccine, which may have a significant risk of serious
adverse events.
Second, the Committee should take note of the fact that vaccine manufacturers
will require indemnity against tort claims resulting from vaccine-related adverse
events. Our current contract at Acambis was awarded based in part on our company
having provided private insurance against such claims for the use of up to 40 mil-
lion doses of FDA-licensed vaccine. The new plan to develop a much larger stockpile
of vaccine, which could be used as investigational product in advance of FDA licen-
sure, is certainly beyond the scope of any possibility of coverage by private insurers.
If this plan is to succeed, the Government must solve the problem of indemnifica-
tion. Thank you once again for the opportunity to address the committee.
Senator HARKIN. Did you state $509 million?
Dr. MONATH. I think that was the figure you mentioned.
Senator HARKIN. What did you say?
Dr. MONATH. We are looking at the cost of providing 300 million
doses of vaccine. We are not quite there. I think in the next day
we have to provide those figures to the Government. I am not sure
the $509 million is going to be enough.
Senator SPECTER. But you read it in the newspaper?
Dr. MONATH. I read it in the newspaper.
Senator HARKIN. That is what we have been asking for, and if
it is not enough, we had better know about it.
Senator SPECTER. It is interesting you would read it in the news-
paper.
Senator HARKIN. Now we turn to Dr. Mary Gilchrist. Dr. Gil-
christ is director of the University of Iowa Hygienic Lab, and presi-
dent of the Association of Public Health Laboratories. I visited the
Hygienic Lab at the University just a couple of weeks ago, and was
very impressed with your ability to rapidly respond, so welcome,
and please proceed.
STATEMENT OF MARY J.R. GILCHRIST, Ph.D., DIRECTOR, UNIVERSITY
OF IOWA HYGIENIC LABORATORY
Dr. GILCHRIST. Thank you, Mr. Chairman, distinguished mem-
bers of the subcommittee. I am honored to be here today to discuss
the critical role the public health laboratories play in bioterrorism
response, including the most recent anthrax attacks. I am going to
142
address three important components that do require attention, the

bioterrorism response network, linkages between public health and
clinical laboratories, and the chemical terrorism response network.
The public health laboratory community spent the last 3 years
preparing for a potential bioterrorism event. The Laboratory Re-
sponse Network, anchored by the CDC, was formed. The public
health laboratories in the cities and States were designated to
shoulder much of the testing. Methods for identification of bacteria,
toxins, and viruses were written, and technologists are being
trained and tested with unknown specimens.
Much remains to be done, but the basic structure is effective, as
demonstrated by the case in Florida. Now is the time to strengthen
the system and fully equip the public health laboratories. At
present, many of the 81 labs in the network are inundated with
suspicious packages, powders, and other challenging specimens.
They require great effort to work up safely, as each is unique. The
testing cannot be sustained indefinitely without burnout, given the
long hours that the technologists are enduring. The testing must
be sustained, however. When testing is readily available, it helps
to control fear so that it does not progress to panic.
Last year, a total of only $8.3 million was provided to fund the
network. This money helped to build a foundation that should now
be enhanced. The APHL is disappointed in the Presidents recently
announced emergency budget for the LRN. We must move beyond
the startup phase, and this will require a substantial increase in
funding that far exceeds the administrations request.
To adequately fund the LRN, a total of $125 million should be
distributed to the States. Funding is necessary for new instruments
that will perform rapid tests, for staffing, chemical supplies, com-
munications, information management, facilities, courier systems,
biosafety and security.
Let me provide an example that we experienced regarding secu-
rity. In Iowa, following the unconfirmed report that the Ames
strain may have been used in Florida, our security issues became
acute. Misleading and inaccurate wording in the press suggesting
an Iowa laboratory connection brought the National Guard to our
door, and this was pictured on the front page of the New York
Times, which spawned interest by other media.
Although the controlled strain at our lab is a vaccine and not a
virulent strain, it was deemed necessary to increase security
against any anthrax agents that may be isolated in the future.
These security advancements were not inexpensive, particularly in
a building that was built in 1917 to serve as a tuberculosis sani-
tarium. Public health laboratories throughout the Nation are crit-
ical infrastructure, and these assets must be secure.
The National Laboratory System is a concept that will more
closely tie the public health laboratories to the 170,000 hospital
and other clinical laboratories, which do most of the testing for in-
fectious agents. Without good linkages between hospital, reference,
and public health laboratories, the rapid emergence of threat
agents may be missed. The complexities of antibiotic resistance and
bioterrorism demand that this system be fully funded and insti-
tuted. To fully fund the LNS, $75 million is necessary.
143
The chemical terrorism laboratory system also requires greater

funding. Currently, only five laboratories in the Nation have this
capacity, and none of these five are located in the Plains States.
Through the events of the past few weeks, we have learned that
our laboratories will be called on to detect both microorganisms
and chemicals in order to evaluate the threats to our society. How-
ever, most, like those in Iowa, do not have the biomonitoring in-
struments that cost several hundred thousand dollars each. To
fully implement this program, a minimum of $100 million is nec-
essary.
The events of the last few weeks have fully demonstrated that
response capabilities must be distributed to the States, and not
solely available through the Federal system for three major rea-
sons. First, the Nations public health laboratories can provide im-
portant redundancy so that if one or more is incapacitated the rest
can take up the slack and provide surge capacity.
Second, they provide geographic dispersal so that ground trans-
portation can be employed should air transport again be com-
promised.
Third and most importantly, they provide local control so that
the most urgent specimens can be prioritized instead of ending up
in a queue of nameless specimens at a regional laboratory.
PREPARED STATEMENT
We must sustain and augment this critical infrastructure. This

can only be accomplished with your help.
Thank you for the opportunity to testify today. I would be
pleased to answer any questions you might have.
PREPARED STATEMENT OF MARY J.R. GILCHRIST
Mr. Chairman and distinguished members of the subcommittee, my name is Dr.
Mary Gilchrist. I am the Director of the University Hygienic Laboratory (UHL),
Iowas public health and environmental laboratory. I am also the president of the
Association of Public Health Laboratories (APHL), representing state and local pub-
lic health laboratories across this nation. We are pleased that the Council of State
and Territorial Epidemiologists (CSTE) support this testimony, and the written
statement reflects comments provided by our epidemiology partners. Both epidemi-
ology and the laboratory must have equivalent strength so that they may function
effectively.
I am honored to be here today to discuss the critical role that public health lab-
oratories play in bioterrorism response, and specifically the most recent anthrax
threats and attacks.
The public health laboratory is a critical component of national and state surveil-
lance for bioterrorism. In order to be prepared for bioterrorism, public health labora-
tories need safe and secure facilities, trained personnel, modern equipment, rapid
assays, and communications tools. Courier services are also needed to move speci-
mens to the public health laboratory. To prepare for chemical terrorism our states
need containment laboratories, trained personnel and equipment to perform rapid
screening for toxic chemicals.
In Iowa, following the unconfirmed and false announcement that an Ames or Iowa
strain may have been used in Florida, our security issues became acute. News that
the Iowa National Guard was guarding laboratories in Iowa City was carried on the
front page of the New York Times and this revelation spawned inquiries from the
networks. Much misinformation was circulated regarding the Ames strain, an iso-
late of Bacillus anthracis that was identified at the National Veterinary Services
Laboratories (NVSL) in Ames some twenty years ago and widely circulated to other
facilities for research purposes. Indeed, although the Bacillus anthracis control
strain at UHL is a vaccine strain and not the Ames strain, it was deemed necessary
144
to increase security against any anthrax agents that may be isolated in the future.
These security advancements are not inexpensive particularly in a building that
originally served as a tuberculosis sanitarium.
To prepare our nations public health laboratories for the biological and chemical
terrorism threats our nation faces we urge enhancement of the following three pro-
grams: The Laboratory Response Network, the National Laboratory System and the
further development of a Chemical Terrorism Preparedness and response program.
The approximate cost for the three components would be $300,000,000. Details for
each of the three components follow.
The Laboratory Response Network (LRN) is critical to the success of the United
States response to terrorism. In order to prepare the LRN member labs at the local,
state, and federal level, and to ensure adequate and appropriate expansion, an addi-
tional $125 million is needed, at a minimum.
The Laboratory Response Network is composed of county, city, state, and federal
public health laboratories, and was established to help public health laboratories
across the nation prepare for and respond to acts of terrorism. It is a joint program
of the CDC and the Association of Public Health Laboratories and was begun about
three years ago. This network of laboratories can accept specimens and samples
from hospitals, clinics, the Federal Bureau of Investigation (FBI) and other law en-
forcement groups, emergency medical services, the military, and other agencies.
With adequate resources this multi-level network will be able to function effectively
even if airplane travel is grounded. During the September 11 attacks in New York
City and Washington, if there had been simultaneous attacks with physical and bio-
terrorism agents patient samples could have easily been transported over the
ground to adjacent states.
The public health laboratory community spent the last three years preparing for
a potential bioterrorism event. The public health laboratories in the cities and states
were designated to shoulder the bulk of the testing for dangerous biologic agents
such as Anthrax, Botulism, Plague, Tularemia and Brucellosis. In fact, the first
(index) case of anthrax in Florida was diagnosed because astute private healthcare
personnel (a clinician and a laboratorian) saw suspicious gram-positive rods and
immediately forwarded the sample to the state public health laboratory, which con-
ducted more sophisticated and more definitive tests, and then went on to alert the
CDC.
Methods for identification of the designated threat strains of bacteria, toxins and
viruses were written and laboratory technologists were trained and tested with un-
known specimens. The basic structure is effective but we must fully fund the infra-
structure in our laboratories to sustain the efforts that are currently underway.
At present, the laboratories in the network are inundated with many suspicious
packages, powders and other very challenging specimens. They arrive in complex
and challenging packaging and require great effort to work up as each is unique.
This testing is demanding and cannot be sustained indefinitely without burnout,
given the risks and long hours that our technologists are enduring.
Definitive identification of agents of biologic terrorism in both an overt or covert
attack is dependent on laboratories having technical capabilities, equipment and
trained personnel. Laboratories must be able to identify a broad range of potential
agents including organisms that could be used to compromise the food supply, water
or air. Conventional identification methods are now in place and more rapid meth-
ods are being evaluated prior to implementation in public health laboratories. There
is no reliable alternative to the testing by the network laboratories.
The hand held devices that are widely touted by industry often provide false posi-
tive results and false negative results and cannot be relied upon to provide accurate
testing at this time. If there are accurate devices, it is not easy to distinguish them
from the problematic ones because reliable evaluations have not been published in
an adequate fashion. In fact a recent CDC Health Alert states the following: Hand-
held assays (sometimes referred to as Smart Tickets) are sold commercially for the
rapid detection of Bacillus anthracis. These assays are intended only for the screen-
ing of environmental samples. First responder and law enforcement communities
are using these as instant screening devices and should forward any positive sam-
ples to authorities for more sensitive and specialized confirmatory testing. The re-
sults of these assays should not be used to make decisions about patient manage-
ment or prophylaxis. The utility and validity of these assays are unknown. At this
time, CDC does not have enough scientific data to recommend the use of these as-
says.
Importantly, the testing taking place in the public health laboratories controls
panic and fear. The ready availability of the testing of these packages, powders and
environmental specimens is also providing the CDC respite from a volume of testing
145
that could never be performed in their laboratories even if the problems with trans-
port, chain of custody and jurisdiction could easily be solved.
Last year, CDC distributed $8.3 million to the state public health laboratories to
prepare for bioterrorism. The dollars provided by the CDC were helpful for a net-
work in formation. It has helped to build a foundation that can be enhanced. It is
now essential that we fully fund the network.
Therefore, we call for substantial increases for the programs at the CDC that are
needed for biological terrorism preparedness and response. Furthermore, we must
ensure that the money designated for the CDC flows to our nations public health
laboratories. The state, county, and city public health laboratories are on the
frontlines in our nations response to this crisis. Without a needed influx of dollars
our states public health laboratories will not have the capacity and capability need-
ed to respond to an emergency situation. Funding is necessary for the following: new
instruments that will perform rapid tests; staffing; chemicals and supplies; commu-
nications; information management; facilities; courier systems; and biosafety and se-
curity. Once again, we call for $125 million for the LRN.
The National Laboratory System (NLS) is an essential component of a laboratory
preparedness plan for biological and chemical terrorism. Currently, the National
Laboratory System (NLS) is a demonstration program funded by the CDC in re-
sponse to the growing threat to public health posed by bioterrorism, food-borne dis-
eases, and emerging infectious diseases. At a minimum, $75 million is needed to
begin to fully implement the NLS in all 50 states.
We are all aware that the health of citizens of the United States is at risk due
to potential and real bioterrorist events or exposure to other infectious diseases in-
cluding organisms that develop antimicrobial resistance. A recent GAO report
(Emerging Infectious Diseases, February 1999), and a Lewin Group Report (Public
Health Laboratories and Health System Change, October 1997) both address the
need for development of a cohesive laboratory system. Consequently, it is important
to develop a system that will allow rapid and accurate information to flow between
public and private laboratories and to define the roles of each in containing the dis-
eases. Detection of a causative agent and its unique properties is essential for effec-
tive public health intervention.
All clinical laboratories are the front-line of detection of events, whether those
events be biologic or chemical. Patients show up at doctors offices and emergency
rooms, not at public health laboratories or public health programs. So public health
is dependent on clinical laboratories to be aware of public health concerns and to
route appropriate specimens/isolates to public health laboratories.
A major goal of the NLS is to facilitate communication and coordination between
public health laboratories and the medical community and hospital/independent lab-
oratories. Accurate and timely laboratory detection is critically important to identify,
track, and limit public health threats like biologic and chemical terrorism. Today,
most diagnostic testing for infectious agents occurs in 170,000 private hospital or
commercial laboratories nationwide. These facilities will very likely be the primary
sites for detecting an act of bioterrorism or the introduction of an unusual infectious
agent into a community.
Improvements are needed in the integration of public health laboratories and pri-
vate clinical and hospital laboratories. These two types of laboratories have inde-
pendent yet complementary roles to safeguard public health. To reach this goal, the
CDC, in conjunction with the Association of Public Health Laboratories, has been
piloting the National Laboratory System within the states of Minnesota, Michigan,
Nebraska and Washington.
The National Laboratory System must be expanded to all states to maximize our
nations preparedness to detect and provide public health interventions for infectious
disease outbreaks. Through improvements in communication, collaboration, and co-
ordination, the NLS initiative is successfully providing links to the public and pri-
vate sectors necessary for an effective response to terrorism, emerging infectious dis-
ease, antimicrobial resistance, and foodborne diseases. All states must be part of a
National Laboratory System. We urge you to provide $75 million to build the NLS.
For Chemical Terrorism Preparedness and Response, expanding the number of
laboratories able to handle chemical agents and agents present in environmental
samples is essential. Minimally, $100 million is needed to enhance and expand pub-
lic health laboratories testing human specimens for chemical terrorism agents as
well as to implement a program of testing for environmental samples. Currently
there is no program in place to test environmental samples and this is a major gap
in testing.
The likelihood that chemical agents will be used for terrorist purposes is high.
Unlike biological agents, chemical agents can produce immediate effects; are cheap,
easy to use, stable, and can be precisely delivered; and can be easily, efficiently, and
146
rapidly dispersed. Terrorists can use thousands of commercially available chemicals.
These chemicals can be purchased throughout the world. These include herbicides,
blood agents, choking agents, blistering agents, and nerve agents.
Last year CDC provided $3.1 million to five state public health laboratories (New
York, Virginia, New Mexico, California and Michigan). In addition to funding, these
laboratories have received training from the CDC, and are beginning to serve as
surge capacity laboratories for CDC chemical terrorism analyses of clinical speci-
mens. At present there are no efforts to provide coordinated laboratory testing of
environmental samples for evidence of terrorist attacks. Once again, we need a min-
imum of $100 million to begin to fully implement these programs.
APHL supports the following testimony regarding building state epidemiology ca-
pacity. These portions of my testimony have been provided to us by the Council of
State and Territorial Epidemiologists.
The Council of State and Territorial Epidemiologists (CSTE) supports the white
paper, Providing a Framework for Public Health Action and Bioterrorism Prepared-
ness: Recommendations for Federal Funding of Public Health Activities, prepared
by the Center for Infectious Disease Research and Policy at the University of Min-
nesota, and the Workgroup on Bioterrorism Preparedness. While this document is
still a work in progress with regard to supporting points, the overall funding rec-
ommendations, and general funding categories, are endorsed by CSTE.
With the Framework as a context, CSTE has specific recommendations within two
funding categories. Under item #1, Improving State and Local Preparedness, item
(b), Staffing, Training, Epidemiology and Surveillance, a total of $400 million is rec-
ommended. Within this total, CSTE recommends the following: $60 million (per
year) to expand the Emerging Infections Program (EIP). The current funding level
is $18 million. State and local health departments must improve their ability to rec-
ognize and respond to bioterrorism events by integrating bioterrorism preparedness
activities into existing communicable disease prevention and control programs.
CDCs Emerging Infections Programs (EIPs), now operational in nine states, have
been highly successful in enhancing the kind of long-term epidemiologic capacity
needed at the state level and county level. The EIPs are built around specific cut-
ting edge surveillance projects that are collaborative efforts between state and
county health departments and the CDC. The infrastructure created by these
projects provides a level of surveillance infrastructure that is uniquely suited to
challenges posed by bioterorrism. The EIPs also have the flexibility to enhance their
capacity to detect a bioterrorism event. This amount of funding would permit expan-
sion to 1620 states and several additional large cities.
$65 million (per year) to expand the Epidemiology and Laboratory Capacity for
Infectious Diseases program (ELC). The current funding level is $50 million. The
ELC for Infectious Diseases program is less structured than the EIP Network and
builds more basic epidemiologic and surveillance capacity in states and eligible local
health departments. Some states have used the ELC to build capacity and have
gone on to become part of the EIP Network. dsELC for Infectious Diseases was es-
tablished in 1995 in response to CDCs national strategy to address emerging infec-
tions. Resources are used to hire and train staff, develop diagnostic and subtyping
methods, implement electronic disease reporting systems, and strengthen collabora-
tion between laboratory scientists and epidemiologists. As of April, 2001, all states
and six Metropolitan health departments, and Puerto Rico have received funds
through ELC. More than 200 epidemiologists, laboratory scientists, and technicians
have been hired with ELC funding and many states now have modern molecular
diagnostic and communications tools. The recommended funding level would double
existing core capacity funding, which averages $250,000 per site, and add a bioter-
rorism component.
Again, within the Framework document, under Item (c) under Improving State
and Local Preparedness is Information and Communications Systems and totals
$200 million. Within this total for this purpose, CSTE recommends the following:
$50 million (per year) to fully implement the National Electronic Disease Surveil-
lance System (NEDSS). The current funding level is $27 million. NEDSS is a system
designed by CDC to integrate a myriad separate databases for public health surveil-
lance so that reporting can be simplified and outbreaks (including bioterrorism at-
tacks) can be rapidly detected and characterized across the different systems and,
very importantly, across an entire state and multi-state region. The system also pro-
vides new, upgraded features such as automatic laboratory electronic reporting and
Geographic Information Systems, or mapping to show where cases are occurring.
While, this year, 57 states and jurisdictions received some NEDSS funding, 21
states who applied for funds to move their systems ahead were not funded due to
insufficient resources. Only two states have fully implemented systems. With addi-
tional funding, CDC could provide intermediate NEDSS capacity to all 50 states; it
147
could add resources to state grants to permit re-examination of their Information
Technology security issues which are not adequate; and it could broaden the soft-
ware licenses beyond just intrastate laboratories to include intrastate providers, re-
porters, and non-laboratory facilities.
$10 million (per year) to fully implement Epi-X. There is no current appropriation
for Epi-X. The Epidemic Information Exchange is software created to provide rapid,
secure communication about outbreaks and other acute or emerging health events
among public health officials. Epi-X is a secure web-based system with participants
from CDC, state and local health departments, and the military. Epi-X also provides
emergency notification by telephone and/or pager for defined groups of public health
officials. The funding level requested would support state and local health depart-
ment efforts in all 50 states and large city health departments to integrate Epi-X
capabilities into their existing and future disease surveillance and outbreak commu-
nications plans.
In closing, I want to thank the members of the Committee for the opportunity to
testify during this time of great need.
Senator HARKIN. Thank you very much, Dr. Gilchrist. Thank you
all for being here.
I will try to ask just a couple of questions. To BioPort, the an-
thrax vaccine right now is not available to civilians. Should it be
made available to civilians?
Mr. KRAMER. As you correctly point out, the stockpile of vaccine
we have is owned by the Department of Defense.
Senator HARKIN. How many doses do they have?
Mr. KRAMER. I have been asked not to comment about the num-
ber of doses that is in the stockpile, but I have been assured that
the HHS and the DOD are coordinating to make sure that that
vaccine will be made available on an emergency basis with the ap-
proval of the FDA.
Senator HARKIN. You are saying the number of vaccines we have
available for anthrax is a classified matter?
Mr. KRAMER. I have been asked not to comment on the number
of doses that are in the stockpile.
Senator HARKIN. I am just wondering, in open testimony, why it
is classified. Does anybody know? Well, I will try to find out why
it is classified. Why should it be? Do you know why it is classified?
Senator SPECTER. No.
Senator HARKIN. I do not know, either. Well, I do not know what
the level of classification is.
The other thing on the anthrax vaccine, do I understand cor-
rectly that if someone is exposed, and they have tested positive,
this vaccine be helpful to them?
Mr. KRAMER. I will let Dr. Myers answer that question.
Dr. MYERS. Animal studies have shown that when both vaccine
and antibiotic are given concurrently after exposure, that protec-
tion is 100 percent. In those same animal studies, if only anti-
biotics were given for a 30-day period, some 17 percent of the ani-
mals, regardless of the antibiotic, 9 out of 29 animals would later
develop anthrax after the antibiotic were taken away.
It suggests also that perhaps the course of antibiotic therapy can
be reduced, therefore expanding the amount of antibiotic that is
available for exposures as well as preventing disease on reexpo-
sure, so we think it has a place, and we think it is certainly up
to the Centers for Disease Control and Health and Human Services
to determine what that place is.
Senator SPECTER. Does that mean that it works?
Dr. MYERS. Yes, it does.
148
Senator HARKIN. That is what it sounds like, although this is

based on animal studies.
Dr. MYERS. That is correct.
Senator HARKIN. If you gave this vaccine to someone who is ex-
posed, what is the risk to that person?
Dr. MYERS. Let me be clear that vaccine alone after exposure is
not protective. It requires vaccine plus antibiotic, but it may pre-
vent some cases of anthrax that would occur after antibiotic treat-
ment is completed.
Senator HARKIN. How about if someone has inhalation anthrax,
would there still be time for the vaccine to work after that?
Dr. MYERS. The Advisory Committee on Immunization Practices
recommends that anthrax vaccine be made available, and that post
exposure treatment be both vaccine and antibiotic for 30 days, until
three doses of vaccine have been given.
Senator HARKIN. Just from a laymans standpoint, it seems to me
if someone has the symptoms of inhalation anthrax, in which I
think the mortality rate is quite highI do not know what it is,
but it is quite highthen what would be the harm in giving that
person the regimen that you suggest, which is antibiotics plus an-
thrax vaccination?
Dr. MYERS. Certainly what we have seen thus far, and what we
would expect from animal studies, is that once symptoms have oc-
curred, the prognosis is poor, and with very aggressive, supportive
therapy, as we have seen, a death might still occur, even if vaccine
and antibiotics were given after the symptoms begin. So it is prob-
ably not going to be real useful at all, after symptoms of inhala-
tional anthrax occur.
Senator HARKIN. If you tested positive at some point for exposure
for anthrax, that is when it is useful?
Dr. MYERS. That is correct, before disease begins, and that is the
recommendation of the Advisory Community on Immunization
Practices.
Ms. Kuhn, what is the price of Cipro right now?
Ms. KUHN. We have an average wholesale price, and there are
other Government prices, but in my job as operations, I am not
really involved in the pricing structure.
Senator HARKIN. So you cannot tell me how much Cipro is?
Ms. KUHN. There are varying prices, depending upon where the
purchase is, but if you would like to discuss the pricing further I
can take the questions and get back to you.
Senator HARKIN. Senator Specter just said here Bayer supplies
Cipro to the U.S. Government at a price of $1.83 per tablet. I guess
my question is, could you provide for the record what was the cost
to the Government per tablet 12 months ago?
Ms. KUHN. I do not have that information with me. I can get
back to you with that.
Senator HARKIN. I think it is incumbent on us to take a look at
what the pricing structure of this is, since it is going to be some-
thing that is going to be, I think, widely used in the United States.
We should take a look at that.
Ms. KUHN. Thank you for that question, and we would welcome
that opportunity.
149
Senator HARKIN. My time is up. Senator Specter.

Senator SPECTER. Thank you very much, Mr. Chairman.
I am very encouraged by what I hear today. When I listen to the
comments from BioPort and Bayer and Acambis and Dr.
Koprowski, I think the terrorists are overmatched. I think that we
have the ingenuity and the capability of meeting this crisis.
When we talk about how much things costwe always do that
around herebut the real question is, what can be produced? What
is our capacity for solving the problems? It is very reassuring to
hear how good it is, so that it is a matter of pursuing these various
courses.
Ms. Kuhn, you talk about what Bayer does and what Cipro does.
I think that it is important to inform the public that Bayer officials
are meeting today with Governor Ridge and also Secretary of
Health and Human Services Thompson to make a determination as
to what the needs are of the Departments to actively protect Amer-
icans. Are the costs being negotiated and discussed in those meet-
ings, to your knowledge?
Ms. KUHN. I do not have the agenda for that meeting so I do not
know if it is being discussed, but we certainly would welcome the
opportunity to have those discussions, because we would also like
to finalize these contracts.
Senator SPECTER. Well, I am sure those people are not sitting
down without getting down to brass tacks, but we would appreciate
it if you could provide the subcommittee with the specifics on that
letter, and I know in the morning press releases that the issue be-
tween Bayer and Canada has been solved. There had been an issue
as to your patents and the takeover of the patents, and that has
been worked out with Canada, recognizing your patents.
Ms. KUHN. That is correct, Senator Specter. We have reached a
deal with the health ministry in Canada for 1 million tablets.
Those 1 million tablets are in their inventory, and in addition we
will take over inventory management of the generic product and
use that as necessary.
Senator SPECTER. The issue of patents, or respecting patents is
a very important one, so that there is motivation in our society for
ingenuity and for development and an appropriate compensation,
but not an inappropriate compensation, and it is important that
pharmaceutical companies, when dealing with a problem of this
sort, deal with the Government, as Bayer is, with the Homeland
Security Director, Governor Ridge, and the Secretary of Health and
Human Services, Secretary Thompson, to arrive at what is a fair
price, and we want to be kept informed about that.
We want to encourage people to develop products, and you have
a constitutional requirement in America that you cannot expro-
priate property. You cannot take property without due process of
law, but the other side of it is that there be fairness, and we want
to pursue that, Ms. Kuhn, and we would appreciate it if you would
report back to us on that.
Ms. KUHN. I will do that, Senator Specter.
Senator SPECTER. Dr. Koprowski, the comments you have made
are really fascinating, especially when the praise does not come
from your home State Senator, but it comes from Senator Harkin,
150
who does not lavish praise without real cause, and so I think that
is quite a tribute to you.
Dr. Koprowski, how fast could this vaccine for anthrax be devel-
oped by your procedures, if you could give us an estimate?
Dr. KOPROWSKI. Senator Specter, it depends upon funds. The
larger the funds, the quicker we can get space and organize it. I
have said in my report that it would be not less, but perhaps not
more than a year. However, if we had more funds we could accel-
erate the process, because it really involves growing plants and
putting the vaccine in plants.
Senator SPECTER. So if you were funded appropriately, ade-
quately, you could do it in less than a year?
Dr. KOPROWSKI. Yes, we could do it in less than a year if prop-
erly funded.
Senator SPECTER. Well, we are going to ask the Federal officials
to take a look at your program to see its potential, and with your
record for solving problems that is something we really want to
take a close look at.
Dr. Monath, when you talk about doses for 54 million people, are
you talking about doses for all Americans?
Dr. MONATH. It has been a changing set of requirements. Our
original contract was for 40 million. That came out of some consid-
erations of the minimum number of doses needed to interrupt an
event using some dynamic modeling. I think everyone has kind of
woken up in the anthrax crisis.
Senator SPECTER. Could you provide us with what it would cost
for 300 million Americans, tell us what that would cost and how
long it would take you to produce it?
Now, are the risks reduced with the vaccine that you are working
on? Dr. Koplan testified earlier that the risks outweigh the bene-
fits, and I heard actually my son tell me yesterday that there was
one chance out of 4,000 on a smallpox vaccine that there would be
very, very serious medical problems. Do you know if that is accu-
rate?
Dr. MONATH. Well, you are referring to the original vaccine, the
only material that is in the stockpile that exists today, the 15 mil-
lion doses at CDC.
Senator SPECTER. The question is, is there a significant risk?
Dr. MONATH. It is about 5 to 10 per million of very severe ad-
verse events.
Senator SPECTER. How about the vaccine which you are pre-
paring?
Dr. MONATH. Well, it has not been made, but our goal is to
match the characteristics of the old vaccine.
Senator SPECTER. In that event, the risk would be present?
Dr. MONATH. The risks are going to be significant, so we really
need to determine, or have a clear policy regarding, the use of
smallpox vaccine.
Senator SPECTER. Well, I compliment you on all you are doing
and the public health experts. This is a massive problem, and I like
what I hear. There is productivity and there is capacity and there
is ingenuity, and there are plans, and it might take us a little time
to get on track, but the Congress is just a facilitator. You people
are the real answers to the problems.
151
With all the money that we would put up, it would not be any-
thing unless we had the productivity and the ingenuity to solve the
problem, and I think the terrorists are overmatched, and we are
going to prove it.
Senator HARKIN. Thank you, Senator Specter.
Dr. Monath, on smallpox vaccine, once you have it, and you have
it in a vial, does it degenerate over time? How long will it last?
How long will it still have efficacy?
Dr. MONATH. You have to remember the material was made by
Wyeth in 1982 which still constitutes our stockpiles. It is a very
stable virus. We are estimating a shelf life of 5 years or more, but
it will be determined by actual testing, real time stability testing.
Senator HARKIN. What you develop will have a shorter shelf life
than what we did previously?
Dr. MONATH. Well, the FDA will give us a shelf life, and what
is happening now with the old stockpile is that it is tested every
year.
Senator HARKIN. We have 15 million doses right now in the
United States, 15 million, and we are relying upon that, I think.
If there ever was an outbreak of smallpox, as I understand it, that
they would begin to vaccinate ever larger concentric circles and
that type of thing. How certain are we that these 15 million vials
of viruses are good, or efficacious, or that they will work? How cer-
tain are we of that?
Dr. MONATH. We are quite certain. There is a simple test that
can be performed on the materials.
Senator HARKIN. That is 20 years old.
Dr. MONATH. Well, people have gotten these pox viruses out of
materials that have been sitting around on a shelf for decades, and
they are still viable. They are very stable viruses. They are the
only class of viruses that have that characteristic, so the vaccine
is remarkably stable. It has to be retested to establish its stability
from time to time, and we expect that the new vaccine will have
a long shelf life. We will have to replace it on a regular schedule.
Our contract calls for a 20-year program.
Senator HARKIN. How would someone ever be able to get a hold
of a smallpox virus that could infect people?
Senator SPECTER. You do not have to answer that question, Dr.
Monath. We do not want to give people any information about that.
Dr. MONATH. Well, I have lived in a world of BW for much of my
career. It could happen.
Senator HARKIN. I just wonder what our real fears are. Are there
real fears out there that people could manufacture or get a hold of
smallpox vaccine? I think we have a right to know. Is this some-
thing serious, or is it not?
Dr. MONATH. I consider it to be serious. We knew in 1989, with
the first Russian defector of a high level, that the Russians had
weaponized smallpox and what has happened to that program is
quite uncertain. Much has been said about the possibility that
other countries, rogue states, have acquired materials from that
program, or maybe acquired it from other means, so I think there
is a credible threat.
152
I think it is less easy to perpetrate than anthrax for a variety

of reasons, but it cannot be dismissed, and it has a bigger problem
associated with it because it can spread, as was mentioned, so it
is a potential epidemic disease.
So whether or not the bad guys have it, I do not know. I do not
think anybody knows, but I think there is a real possible risk, and
we have to be prepared for it.
Senator HARKIN. I understand. Regarding the 300 million doses,
I figured it would cost up to a little over $3 billion as an estimate.
Dr. MONATH. I hesitate, Mr. Harkin, to give you a number.
Senator HARKIN. You gave me $11 a dose.
Dr. MONATH. That was the anthrax vaccine. I do not think it is
going to be quite that much.
Senator HARKIN. Well, I would like to get a handle on that, and
how fast we could ramp up.
Dr. MONATH. We are providing information to the Government
Thursday.
Senator HARKIN. Could you provide us with that kind of informa-
tion?
Dr. MONATH. The information actually is being provided to the
Department on Thursday in response to a request for information
issued last week.
Senator HARKIN. One last question I have, and I wanted to ask
Dr. Koplan about it, but maybe I will ask some of you. Maybe, Dr.
Gilchrist, you are the proper person to respond to this.
There is a front-page article in the paper this morning, well,
maybe not the front page. It was on page 11. It says, irradiation
is the answer to anthrax. The process used on food can be adapted
to rid the mail of pathogens. They talk about electron beams. I am
very familiar with that, having started funding a long time ago in
the House for the first food irradiator at Iowa State University al-
most 20 years ago. They first used cobalt, and then they moved
into electronic beam pasteurization, or irradiation.
There is a facility now right outside of Sioux City, which I saw
a year or so ago. It is now being operated by this company men-
tioned here in the paper, the Titan Corporation, and a subsidiary
called Sure-Beam Incorporated. They have a big electronic pasteur-
ization facility there for meat in Sioux City, Iowa, so all of the
hamburger and meat that goes through this electronic pasteuriza-
tion kills all the pathogens.
They asked whether the beam could kill anthrax, and they re-
plied yes, anthrax bacteria and the spores. Evidently it could do it
right within envelopes, within packages and things like that. Could
you enlighten us, any of you, on this, and is this a viable thing to
look at as a way of protecting our people?
Dr. GILCHRIST. To me it seems very probable that it would work
here. You are usually trying to get at the nucleic acids, the spores
resistance, because it protects other parts of the cell. So the fact
that you would have to irradiate the envelope and get to the
spores, there would be some physical needs you would have to pay
attention to. Obviously the need up front is to make sure that the
envelope from where it was mailed to where it was irradiated was
not a risk to anyone, so those are the things that I see.
153
I think it should work, absent the concern for the pre-attention

to the irradiation. We are now concerned about where were they
mailing things, for example, and where do they get sorted. It has
to be handled somehow before it gets irradiated, so those would be
the only concerns that I would have right now.
Senator SPECTER. Mr. Chairman, I have one more question, if I
may.
Mr. Kramer or Dr. Myers, there had been reports in the media
about people in the military who were given the anthrax immuni-
zation objecting to it, getting sick from it. Are those myths?
Mr. KRAMER. I think if you look at the safety studies that have
been provided in the written testimony, you will see that the an-
thrax vaccine has a side-effect profile that is very similar to any
other vaccine. At the site of injection you get redness. There is
some swelling.
Senator SPECTER. So there are some side effects?
Mr. KRAMER. There are some local side effects, but not unlike
any other vaccine such as diphtheria or tetanus which we give our
children.
Senator SPECTER. Some of the military personnel, according to
the reports, refused to take it. Do you know if that is a myth, or
true?
Mr. KRAMER. Well, you are correct in that some of the military
people have refused to take the vaccine, but there is no evidence
that I am aware of to support their allegations that what they are
claiming was caused by the vaccine.
Senator SPECTER. Thank you very much.
Senator HARKIN. Thank you, Senator Specter. Thank you all for
being here. I think one thing is quite clear that came out of this,
and that is, we are going to do more to help our local public health
agencies in the bill that we are coming up with, aside from looking
at how much we need to put in for smallpox.
SUBCOMMITTEE RECESS
ing.
[Whereupon, at 1:30 p.m., Tuesday, October 23, the sub-
Chair.]
BIOTERRORISM
FRIDAY, NOVEMBER 2, 2001
U.S. SENATE,
Washington, DC.
The subcommittee met at 9:05 a.m., in room SD192, Dirksen
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
Present: Senators Harkin, Byrd, Specter, and Stevens.
SMALLPOX
Senator HARKIN. The Subcommittee on Labor, Health, Human

Services, Education, and Related Agencies of the Senate Appropria-
tions Committee will come to order. The subcommittee today will
have its third hearing on the subject of our Nations preparedness
for bioterrorism.
This mornings hearing will focus on the threat posed by small-
pox. In the past couple of weeks we have seen the havoc that can
be created by just a few grams of anthrax spores. Several Congres-
sional office buildings were shut down, mail has been disrupted
over much of the east coast, and four people have died. So I find
it less than comforting when I am told that the greatest risk is not
from anthrax, but from smallpox.
An exercise this past June called Dark Winter started with 24
simulated cases of smallpox in Oklahoma, Pennsylvania, and Geor-
gia. The exercise ended after 2 weeks with 1,000 people dead,
15,000 people infected, and the Nations stockpile of 15 million vac-
cine doses entirely gone. Had it continued, they expected the num-
ber of cases would have grown by a factor of 10 every 2 weeks. For-
tunately, this was just an exercise. Nearly one-third of people who
contracted the most common type of smallpox died and there is no
known cure. Unlike anthrax, smallpox is contagious and a small at-
tack could spin out of control.
There seems little doubt that our efforts to date have not ade-
quately prepared us for this threat. We do not have enough vac-
cines to respond to an attack. Our public health system has been
allowed to decay and needs more help to detect an outbreak quick-
ly, to treat a large number of infectious patients, and to vaccinate
large parts of the country.
Under the leadership of Senator Byrd, the proposal that we have
put together includes funding for the production of enough small-
(155)
156
pox vaccine for every American, should that ever be necessary. It

also includes funds to beef up our public health capacity at the
local level so that we will be better able to identify and track and
contain a smallpox outbreak should we ever be confronted with it.
We expect and hope to include our package in the emergency sup-
plemental appropriations bill to be taken up shortly.
This morning I hope we will learn more about what we can do
to better protect against the threat of smallpox. I hope several
questions will be answered today: How likely is the threat of a
smallpox attack? What is the current state of the stockpile? How
many of the doses that we have are still effective? How can we get
these doses out rapidly? How quickly can 100 million doses be
made to protect all Americans? What else do we need to do to pro-
tect ourselves, and how prepared are we at the local level to vac-
cinate on a mass scale?
So again, as I said, this subcommittee, under the leadership of
Senator Byrd and with Senator Specter, has developed a com-
prehensive $2.3 billion plan to better protect Americans from the
threat of smallpox and other bioterrorism threats.
We have a distinguished panel this morning who will help to en-
lighten us on these questions. I look forward to the testimony and
to their answers to the subcommittees questions.
Before we start, I will recognize first my ranking member Sen-
ator Specter and then our distinguished chairman of our full com-
mittee, Senator Byrd.
Senator SPECTER. Well, thank you very much, Mr. Chairman. I

commend you for convening this hearing on a Friday morning. I
think it is appropriate to note that this subcommittee has been
very attentive to health care issues. Senator Harkin was chairman
of the committee in 1991, 1992, 1993, and 1994. I took over in
1995, 1996, 1997, 1998, and 2000, until the middle part of this
year.
But what Senator Harkin and I like to emphasize, and I think
it is worth noting because people are so concerned about the need
for bipartisanship and to end the bickering on Capitol Hill, is that
it does not make any difference which of us is chairman. I slightly
prefer it when I am chairman, but the public interest is promoted
either way.
We got a very unique compliment this morning, which I do not
think is confidential, I will share with you. Senator Byrd called us
the health care twins. I said to Senator Byrd, who is the senior
Member of Congress, having been elected in 1952 to the House and
1958 to the Senate, about to celebrate 50 years on Capitol Hill,
that was quite a high compliment.
Senator Harkin and I have been very attentive to the National
Institutes of Health and to health funding at every level. We have
taken a look at this issue of bioterrorism and before the recent con-
cerns we had put in the budget $338 million, last year over $290
million, the year before $255 million. But the fact is that until
there was such a focus of attention there was not the ability to put
the kind of funds in which are really necessary to deal with the
threat that we have now.
157
We had the Secretary of Health and Human Services in a few

weeks ago and we were a little concerned about being candid with
the American people and that there ought not to be an overrepre-
sentation, as the statement had been made that we were prepared
for any contingency. I made a comment that I thought it was coun-
terproductive to do that. If we lay it on the line, people will under-
stand. They want to know what we are doing now.
When Senator Byrds turn came he said, in an interesting, maybe
flamboyant, gesture: I do not believe you. That is the value of sepa-
ration of powers. We can speak perhaps a little more candidly and
a little more bluntly because we are separate and we are inde-
pendent. But before that day was up a letter drafted by Senator
Byrd, the chairman of the full committee, was sent out with Sen-
ator Stevens, ranking on the full committee, and Senator Harkin
and myself to the President, asking him what he needed and we
were prepared to give him what he needed, Congress was prepared
to do that.
As Senator Harkin has noted, we have a package in excess of $2
billion and it may go beyond that, because the real issue is what
are the resources of our country, our capability for the vaccines and
the health preparedness measures. We have a very wealthy, pro-
ductive, ingenious country and we can meet this threat.
I might tell you on the personal level it is disconcerting to be 100
yards from the Hart Building and not to be able to get into my of-
fice. Senator Daschle had the anthrax envelope. I am right above
him. We could not get in the office, and I was tested, fortunately
negative, and took Cipro. It is no funan adverse reaction. I
missed a day of squash.
But I did not think it was possible to get Congress more fighting
mad than the September 11 attack, but this anthrax business has
done that, and we are prepared to move. I am glad to see the ex-
perts here to give us the information as to what ought to be done
and how it ought to be done, and we will provide the funding from
the Appropriations Committee.
Now I turn to our distinguished chairman of our entire Appro-
priations Committee, Senator Byrd.
OPENING STATEMENT OF SENATOR ROBERT C. BYRD
Senator BYRD. Thank you, Mr. Chairman. Thank you for con-
ducting these hearings. This is where the action is, and these are
indeed the health care twins. They are both very courteous, very
responsive to our health needs, and they are men of action. I have
found that in the case of each of them when each has been chair-
man. So I compliment them and thank them.
I thank you for convening this important hearing on smallpox. I
thank the chairman for giving me this moment to address the sub-
committee and the witnesses.
Smallpox, whose world eradication in 1980 was hailed as one of
public healths greatest triumphs, has turned from a success story
to a bioweapons specter. Banquos ghost at the head of the table
is there. Now public health officials in the wake of the September
11 terror attacks are scrambling on several fronts to guard against
158
a nightmare scenario involving the intentional release of the small-

pox virus on a vulnerable population with waning immunity or
none at all against the disease.
Smallpox epidemics have changed the course of history, killing as
many as half their victims and crippling entire civilizations. In the
Twentieth Century, smallpox has killed millions, scores of millions,
even hundreds of millions of people, far more than all of the cen-
turys wars combined. Smallpox causes unspeakable misery. It can-
not be cured with current drugs and spreads easily from person to
person.
Thus, in the event of a bioterrorist smallpox attack, our country
needs to be prepared to avert widespread fever and immediate sys-
tem disruptions on a national scale. The only hope of containing an
outbreak is when it is still in the foothill stages, when the number
of infections is low and targeted vaccination can be used to choke
off the virus. Catching an outbreak early keeps it from erupting.
Unfortunately, the public health community seems ill-prepared
for an influx of patients and the ensuing chaos. Remember Miltons
Paradise Lost. He used the word chaoschaos.
Since the first case of anthrax was diagnosed in Florida a month
ago, almost every assumption about anthrax has been challenged,
if not disproved outright. Scientific and medical wisdom has been
revised daily, it seems. As our Nation prepares for potential small-
pox attacks, it is imperative that we learn from the experience that
we have gained in dealing with the anthrax problem.
You know, there were ten plagues of Egypt, and I will see if I
can name them in order: blood, frogs, lice, flies; and then there is
murrain, I believe it is murrain of cattle, horses, camels, m-u-r-r-
a-i-n. That is the one I want to settle upon, so I will not complete
the seven. There are actually 10 plagues.
But that is the one, murrain. So I have looked up that word
murrain. It was spoken of in the book of Exodus, having to do
with the efforts of Moses to get pharaoh to release the people, re-
lease his people. So I have looked it up in the dictionary. The dic-
tionary tells me that it is a disease of cattle, like anthrax; murrain,
like anthrax.
So among the seven plagues, the nine plagues of Egyptsome
will say there are 10there is murrain of cattle, a disease like an-
thrax. That is going back a long way.
It is my hope that we can translate our discussions today into
a tangible plan of action to deal with the threat of bioterrorism
that for too long we have been reluctant to recognize. Shoring up
our public health infrastructure is certainly one of the solutions
and we have been tardy in coming to a realization of the impor-
tance of our doing something about these potential catastrophes.
As I have been saying for some time, we need to make more in-
vestments in the wellbeing of our citizens on our own soil. As part
of a $20 billion economic stimulus package, as the chairman has
said, I have recently proposed $3.1 billion for bioterrorism preven-
tion and response efforts to strengthen our public health infrastruc-
ture and restore confidence in our homeland security.
Congress must act now to ensure the security of this Nation and
the American people. You are taking a great first step here. Here
is where the action is. You impressed me greatly the other day, Mr.
159
Chairman, when you spoke of the need to spend $2 billion or $2.5

billion on clean water, on safe water, when you pointed out that
there are $22 billion requests backlogged for clean and safe water.
Now you are dealing with the problem another day in another way
and having this hearing.
I certainly thank you, and I thank Senator Specter.
Senator HARKIN. Mr. Chairman, thank you so much. It is always
a learning experience to listen to you and a learning experience to
be on your committee.
I personally, and I think on behalf of all the American people,
want to thank you for your strong leadership in this area. You
were the first one, when we started talking about putting all of this
money in to fight terrorism, to say, wait a minute, we have to think
about bioterrorism and think about putting that money aside for
that and focusing on it.
You have led the way on that and we are proud to follow in your
wake.
Senator BYRD. You are my chairman. Just command me; I am
your lieutenant.
Senator HARKIN. I think it is the other way around. But thank
you so much, Mr. Chairman.
We have a good panel here. I will introduce each of them and
then we will start with Dr. Fauci and work on down. First we have
Dr. Fauci, who first joined the National Institute of Health in 1968.
Since then he has had a distinguished career at the National Insti-
tute of Allergy and Infectious Diseases. He became Director of that
Institute in 1984. Dr. Fauci has made many important contribu-
tions to research regarding immune-mediated diseases, especially
with regard to the AIDS virus.
Next will be Dr. James LeDuc. Dr. LeDuc is the Acting Director
of the Division of Virus and Rickettsial Diseases of the Centers for
Disease Control and Prevention. Prior to joining the CDC, Dr.
LeDuc served for more than 20 years as an officer in the U.S.
Army, where he directed studies on the epidemiology of virus dis-
eases.
Dr. Michael Friedman was appointed this week to coordinate the
pharmaceutical industrys initiative to combat bioterrorism. He is
currently a Senior Vice President at Pharmacia Corporation. Prior
to joining the pharmaceutical industry, Dr. Friedman served in the
Public Health Service for 20 years and held the rank of Rear Admi-
ral and Assistant Surgeon General.
Dr. Anita Barry is the Director of Communicable Disease Control
at the Boston Public Health Commission. She is a member of the
Council of State and Territorial Epidemiologists and the American
Society for Microbiology, and serves on the Advisory Board for the
Greater Boston Biodefense Collaborative.
We thank you very much for taking time from your busy sched-
ules to be here to enlighten us.
We are now graced also by our ranking member of the full Ap-
propriations Committee, the former chairman, Senator Stevens. I
am delighted to yield to Senator Stevens for any opening remarks
or comments that Senator Stevens might have.
160
OPENING STATEMENT OF SENATOR TED STEVENS
Senator STEVENS. I have extreme interest in this subject and am

pleased to join you. Thank you.
We are graced by both the chairman and the ranking member of
the entire Appropriations Committee, so you can see how impor-
tant this is to our Senate.
STATEMENT OF ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTI-
TUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL IN-
STITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Senator HARKIN. With that, Dr. Fauci, welcome. All your state-
ments will be made a part of the record in their entirety, and we
would like if you could sort of sum up in maybe 5, 7 minutes each,
I would sure appreciate it. Dr. Fauci.
Dr. FAUCI. Thank you, Mr. Chairman, Senator Byrd, Senator
Stevens. We appreciate your calling this hearing and giving us, my
colleagues and I, the opportunity to address the threat of smallpox
bioterrorism and how we may as a group defend against the bioter-
rorist potential of this pathogen. I represent the National Institutes
of Health, which is a component of a multifaceted effort including
government and nongovernment, our colleagues, others represented
here at this table.
Smallpox is just one of many bioterrorist threats, as you have
just mentioned, Mr. Chairman, but perhaps it is the most fright-
ening. Even though the disease was eliminated from the world with
the last case documented in 1977, stocks of smallpox vaccine are
known to exist in secure facilities, one in the United States and one
in Russia. But there are other possibilities that stores may exist
outside of those locations, so the threat of the use of smallpox as
a bioterrorist weapon are real.
Smallpox is caused by Variola major. It is a virus that is easily
transmitted from person to person through aerosolized droplets
from saliva and other body fluids. It is unlike anthrax in that it
can be transmitted from person to person and not just a danger by
a direct contact. The symptoms typically appear about 12 days
after exposure, with a characteristic clinical syndrome. At least 30
percent of people infected die and many survivors are disfigured.
In some respects, the situation that we are in today is what we
call a victim of our own success, because smallpox was eradicated
with a very good vaccine in what is probably the most successful
and unprecedented story of a public health victory in the eradi-
cation of smallpox.
The Dryvax vaccine, or the classic vaccine that for decades has
been used in the ultimate elimination of smallpox, was last pro-
duced about 20 years ago. It is very effective in prevention and also
likely in post-exposure prophylaxis. This vaccine has not been
given routinely in the United States since 1972, except for, for ex-
ample, workers, laboratory workers who work with related viruses.
The military discontinued it several years ago.
In other words, the population, as you alluded to just a little bit
ago, who were vaccinated years ago certainly have waning immu-
161
nity, namely decreasing immuniaty. The exact extent of that resid-

ual immunity is really unclear.
In that regard, we have about 15 million doses of the classic
original Dryvax vaccine available and owned by the Federal Gov-
ernment. This is not enough for a large-scale epidemic. In this re-
gard, a three-pronged or three-phased approach has been imple-
mented to increase the availability of vaccine.
The first is one that I am sure you have heard of, is the
dilutional study, namely to take the 15 million doses, take an ali-
quot of that and determine, if you dilute it one to five or one to
ten, do you get comparable safety as well as what we call a take
rate, namely a characteristic skin lesion accompanied by an
immunological response. If we are successful, and we have reason
to believe that we very well might be since a preliminary study
showed that a one to a hundred dilution really did not give a good
response, one to ten gave approximately 70 percent take. We want
to do better than that.
In the end of October, literally now, October the 26th, we initi-
ated a second dilutional study involving over 650 people. In that
we are comparing a one to five with a one to ten dilution. If for
example a one to five dilution is successful, then we will have am-
plified our 15 million doses to approximately 75 million doses. We
consider that a short-term, not solution, but a short-term ameliora-
tion of the shortage response.
This must come in parallel with what we call an intermediate
and a long-range solution. The intermediate solution is to produce
a second generation smallpox using not the typical calf lymph ap-
proach, but using a cell culture-based approach that will be revved
up and accelerated using not only the company that was originally
contracted, namely Acambis, but also other large corporations that
are being discussed now, which will be large pharmaceutical cor-
porations that would hopefully get us to the desired 300 million
doses by the end of the year 2002 and perhaps before that.
There is a third generation of smallpox vaccines that are in the
research phase, namely one that we look to several years from now,
anywhere from 2 or more years, one that is using a type of virus
that might give less potential toxicities such that pregnant women
and people with weakened immune systems might be able to be
vaccinated. That is more than a year or so away. We consider that
the long-range solution.
Finally, in therapeutics, currently only supportive therapy is
used for individuals who are infected for smallpox. However,
screening efforts have identified the possibility of using anti-virals
not only to combat as a second line defense against the potential
toxicities of vaccination, but also in an experimental fashion to use
in the treatment. One, for example, is a drug called Cidofovir that
is made by the company Gilead, that was originally made as a drug
to combat cytomegalovirus in HIV-infected individuals.
We now have an investigational new drug application to look at
this drug in the vaccination program and we are working towards
getting an IND to perhaps use it in treatment if necessary. In addi-
tion, we are working with the United States Army and USAMRIID
to screen a number of compounds that might have potential use as
a treatment of smallpox.
162
PREPARED STATEMENT
In conclusion, the NIH is committed to focusing its basic and

clinical research efforts to approach and hopefully overcome this
bioterrorism threat. We are committed to working together with
our sister agencies in the Federal Government as well as with in-
dustry and the local and State public health groups in a com-
prehensive effort to keep the citizens of our Nation safe from the
threat of a smallpox bioterrorism attack.
Thank you, Mr. Chairman. I would be happy to answer questions
later.
PREPARED STATEMENT OF DR. ANTHONY S. FAUCI
Mr. Chairman and Members of the Committee, thank you for inviting me here
today to discuss the threat of smallpox as a weapon of bioterrorism and the current
efforts by the National Institutes of Health (NIH) to accelerate basic and clinical
research related to the prevention and treatment of smallpox.
Recent events, notably the attacks on the World Trade Center and Pentagon and
numerous incidents involving the intentional spread of anthrax spores, have high-
lighted our Nations vulnerability to attack by bioterrorists. In addition to anthrax,
other potential agents of bioterrorism include smallpox virus, the bacteria that
cause plague and tularemia, botulinum toxin, filoviruses (e.g. Ebola virus) and
arenaviruses (e.g. Lassa virus), and other selected pathogens.
As concern grows about the use of biological agents in acts of terrorism or war,
federal health agencies are evaluating and accelerating measures to protect the pub-
lic from the health consequences of such an attack. The National Institute of Allergy
and Infectious Diseases (NIAID), a component of the NIH, supports research on the
diagnosis, prevention and treatment of infections caused by a wide variety of patho-
gens, including those with potential for use as biological weapons.
Our ability to detect and counter bioterrorism depends to a large degree on the
state of biomedical science. Basic and applied research supported by NIH com-
plements the efforts of other agencies by developing the essential toolsdiagnostic
tests, therapies and vaccinesneeded by physicians, nurses, epidemiologists and
other public health workers to prevent and control a disease outbreak.
SMALLPOX: THE DISEASE
Smallpox, caused by a virus known as Variola major, is considered one of the

most dangerous potential biological weapons because it is easily transmitted from
person to person, and because few people carry full immunity to the virus. Although
a worldwide immunization program eradicated smallpox disease in 1977, small
quantities of smallpox virus still exist in two secure facilities in the United States
and Russia. However, it is possible that unrecognized stores of smallpox virus exist
elsewhere in the world.
The symptoms of smallpox infection appear approximately 12 days (range: 7 to
17 days) following exposure. Initial symptoms include high fever, fatigue, and head
and back aches. A characteristic rash, most prominent on the face, arms, and legs,
follows in 23 days. The rash starts with flat red lesions (a maculopapular rash);
the lesions evolve at the same rate. Lesions become pus-filled and begin to crust
early in the second week. Scabs develop and then separate and fall off after about
34 weeks. Individuals are generally infectious to others from the time period imme-
diately prior to the eruption of the maculopapular rash until the time of the shed-
ding of scabs. The mortality of smallpox infection is approximately 30 percent; those
patients who recover frequently have disfiguring scars. Smallpox spreads directly
from person to person, primarily by aerosolized saliva droplets expelled from an in-
fected person. Contaminated clothing or bed linens also can spread the virus.
Smallpox vaccine has proven to be highly effective in preventing infection. In
unvaccinated people exposed to smallpox, the vaccine can lessen the severity of, or
even prevent, illness if given within 4 days after exposure. Vaccine against smallpox
does not contain the smallpox virus, but rather a laboratory strain of a related virus
called vaccinia.
Vaccinations to prevent smallpox have not been required in the United States
since 1972. People vaccinated prior to 1972 very likely have diminished immunity
to smallpox; people born in the United States after 1972 are not routinely vac-
163
cinated. Currently, smallpox vaccination is recommended and available only for in-
dividuals who are at risk of imminent exposure, such as laboratory personnel who
work with orthopox viruses related to smallpox virus, including vaccinia. No new
smallpox vaccine has been manufactured in almost 20 years.
SMALLPOX RESEARCH: VACCINES
The NIAID strategy for smallpox vaccine research is a three-part program that
addresses immediate, intermediate, and long-term needs. In the near-term, a bioter-
rorist attack involving smallpox would require the utilization of stores of the exist-
ing smallpox vaccine. Approximately 15 million doses of the FDA-approved Dryvax
vaccine have been stored since production stopped in 1983. This clearly would not
be enough to respond to a national smallpox epidemic. As a response, NIAID last
year initiated a study to determine the feasibility of expanding the use of the exist-
ing stores of the Dryvax vaccine by dilution. In this study, investigators examined
the skin and immune system responses of normal unimmunized adult volunteers
who were given a 1:10 dilution (10 percent) or a 1:100 dilution (1 percent) of off-
the-shelf Dryvax vaccine They compared responses to those from other volunteers
who had received the full-strength vaccine. The results showed that the full-
strength vaccine had maintained its potency, and that 70 percent of people who re-
ceived a single dose of the 10-percent vaccine developed a sore followed by a scab
at the injection site and antibodies in their blood, indicating protection. Even though
the 10-percent vaccine was capable of stimulating an immune response in most peo-
ple in the study, it is unlikely that it would protect enough people in a large popu-
lation to sufficiently stop the spread of smallpox. Based on these findings, a new
study was designed to determine if a diluted vaccine combined with an alternative
vaccination schedule could protect a greater number of people than did the standard
dose and regimen.
This study, which will enroll up to 684 people, is evaluating three different doses
of Dryvax. Researchers will study the ability of the various vaccine formulations to
stimulate a scab, or take, at the vaccination site and to produce antibodies in the
blood. If participants have not developed a scab in seven to nine days after vaccina-
tion, they will be revaccinated with the same vaccine they received the first time.
By that strategy, researchers hope to learn which vaccine dose given in a single in-
jection elicits the best response among the largest number of people and whether
boosters can fortify the immune response in those who did not react to the first
vaccination. This study is being conducted at several NIH Vaccine and Treatment
Evaluation Units around the United States, including Saint Louis University,
Baylor College of Medicine, the University of Maryland, and the University of Roch-
ester. Recruitment of study participants began on Oct. 26, 2001.
NIAID-intermediate-term plans include development of a new smallpox vaccine:
a safe, sterile product grown in cell cultures using modern technology. This vaccine
will be rapidly tested in human clinical trials; 250 million doses will be produced
and delivered to the federal government by the end of 2002. In the long-term, basic
research promises to provide a third generation of smallpox vaccines that could be
used in all segments of the population, including pregnant women and people with
weakened immune systems. As the research evolves, NIAID continues to be actively
involved in the development and testing of new vaccines, including the initiation of
clinical trials to determine vaccine safety and efficacy, particularly in special popu-
lations.
THERAPEUTICS RESEARCH
NIH therapeutics research focuses on the development of new antimicrobials and

antitoxins, as well as the screening of existing antimicrobial agents to determine
whether they have activity against organisms that might be employed by bioterror-
ists. For example, in collaboration with DOD, NIH has rigorously screened a large
number of antiviral drugs against smallpox and related viruses. One of these agents
is an antiviral called cidofovir, which is approved by the Food and Drug Administra-
tion (FDA) for treating certain AIDS-related viral infections. Cidofovir has shown
potent activity against smallpox and related viruses in test tube studies and in ani-
mal models. NIH has taken the lead in developing a protocol that would allow
cidofovir to be used in emergency situations for the treatment of smallpox. Concur-
rently, other anti-smallpox agents are being investigated. NIAID and the U.S. Army
Medical Research Institute of Infectious Diseases (USAMRIID) funded initial
screening of approximately 500 compounds for potential antiviral activity against
smallpox. Compounds were selected for antiviral testing from the following cat-
egories: FDA approved drugs effective against other viruses; antiviral compounds in
clinical development for other viruses; known experimental antiviral compounds;
164
and new chemical entities. Several drugs tested in these screening studies, including
several cidofovir derivatives, have been shown to be active against both vaccinia and
cowpox by in vitro evaluation. Promising leads will be further tested with additional
in vitro studies, animal model testing, or combination therapy studies. In addition,
the design of medications active against known drug-resistant variants of microbes
and the development of broad-spectrum agents are important NIH research prior-
ities.
Together with our many research partners, NIH has made substantial progress
in the research effort that is critical to our Nations fight against terrorism. Much
remains to be accomplished, however, and the challenges posed by bioterrorism will
require a protracted and sustained commitment. With a strong research base, tal-
ented investigators throughout the country, and the availability of powerful new re-
search tools, we fully expect that our basic and applied research programs will pro-
vide the essential elements that will help enhance our defenses against those who
attempt to harm us with bioterrorism.
This concludes my testimony. I would be happy to answer any questions which
you or members of the Subcommittee may have.
Senator HARKIN. Dr. Fauci, thank you very much for a very
straightforward presentation.
Dr. LeDuc.
STATEMENT OF JAMES W. LeDUC, Ph.D., ACTING DIRECTOR, DIVISION
OF VIRAL AND RICKETTSIAL DISEASES, NATIONAL CENTER FOR
INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND
PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. LEDUC. Good morning, sir, and thank you for the invitation.
I will proceed to brief you on our response to smallpox.
It is CDCs responsibility to provide national leadership for the
public health and medical communities to detect, diagnose, and re-
spond and prevent illnesses, including those that are a result of in-
tentional release of agents. This task is an integral part of CDCs
overall mission, which is to monitor and protect the health of the
United States.
It is within this context that CDC is preparing our Nation to re-
spond to biological terrorism. Last year CDC issued a strategy out-
lining steps in five areas to protect the Nation against these
threats. The first priority area is preparedness and prevention.
CDC is working to ensure that all Federal, State, and local public
health officials are prepared to work with medical and emergency
response communities to address the consequences of biological and
chemical terrorism.
We are developing performance standards and we are helping
States to conduct exercises to assess local readiness for these
issues. As Dr. Fauci just said, we are working in collaboration with
scientists at NIH, the Department of Defense, and other agencies
to actively research issues on smallpox virus, including anti-viral
drugs. We are producing additional smallpox vaccine and we are
making sure that the vaccine we now have, the 15 million doses
that Dr. Fauci mentioned, are safe and ready for immediate use.
The second priority area is disease surveillance. As was seen re-
cently in Florida, the initial detection of a biological terrorist act
will most likely occur at the local level. This is the area that we
need to focus our attentions. To do this, we must upgrade surveil-
lance systems of State and local health departments and strength-
en their linkages with health care providers so that unusual pat-
terns of disease can be promptly recognized and responded to.
In preparing to respond to smallpox, CDC is building dedicated
response teams and we will be offering specialized training both to
165
State and local health officials and clinicians to better prepare

them to handle this tragedy.
Third, to ensure that the control strategies and treatment meas-
ures can be implemented promptly, we need to focus on rapid diag-
nostic capabilities.
Fourth, a timely response to a biological terrorism event involves
a well-rehearsed plan to detect, to investigate, and treat. We are
assisting State and local health agencies to develop these tests. Be-
cause hospitals play a critical role in the response to bioterrorism
activities, we are working closely with the various health care insti-
tutions and associations to better prepare them for potential bioter-
rorism events.
The fifth priority area deals with communications. Rapid and se-
cure communications are crucial to ensure a prompt and coordi-
nated response. CDC is building the Nations public health commu-
nications infrastructure through an effort called Health Alert Net-
work. We communicate with the public directly through our web
site and through a telephone and email system which since the re-
cent attacks has literally responded to hundreds of inquiries every
day.
As has been highlighted recently, increased vigilance and pre-
paredness for unexplained illnesses are an essential part of the
public health effort to protect the American people against bioter-
rorism. Prior to September 11, CDC was making substantial
progress towards developing and implementing a nationwide public
health response network to help public health officials respond to
deliberate attacks.
The events of September 11 were a defining moment for all of us.
Since then, we have dramatically increased our levels of prepared-
ness and we are continuing to do so.
PREPARED STATEMENT
In conclusion, the best public health strategy to protect the Na-

tion against biological terrorism is strengthening the public health
surveillance and prevention systems. Priorities include improved
laboratory capacity, increased surveillance and outbreak response
capabilities, and better health communications, education, and
training. Not only will this approach ensure that we are prepared
for a deliberate biological terrorism attack, but it will also improve
our national ability to promptly detect and control naturally occur-
ring outbreaks of infectious diseases.
Thank you very much, sir, for your attention. We will be happy
to answer any questions.
PREPARED STATEMENT OF DR. JAMES LEDUC
Good morning, Mr. Chairman and Members of the Subcommittee. I am Dr. James
LeDuc, Acting Director, Division of Viral and Rickettsial Diseases, National Center
for Infectious Diseases (NCID), Centers for Disease Control and Prevention (CDC).
Thank you for the invitation to update you on CDCs public health response to the
threat of smallpox. I will address specific activities aimed at preparedness for a de-
liberate release of variola virus, the pathogen responsible for smallpox.
As you are aware, many facilities in communities around the country have re-
ceived anthrax threat letters. Most were received as empty envelopes; some have
contained powdery substances. However, in some cases, actual anthrax exposures
have occurred. As of Wednesday, October 31, 10 cases of inhalational anthrax and
166
10 cases of cutaneous anthrax have been identified in Florida, New Jersey, New
York, and Washington, DC. This is the first bioterrorism-related anthrax attack in
the United States, and the public health ramifications of this attack continue to
evolve. In collaboration with state and local health and law enforcement officials,
CDC and the FBI are continuing to conduct investigations related to anthrax expo-
sures. During this heightened surveillance, cases of illness that may reasonably re-
semble symptoms of anthrax will be thoroughly reviewed. The public health and
medical communities continue to be on a heightened level of disease monitoring to
ensure that any potential exposure is recognized and that appropriate medical eval-
uations are given. This is an example of the disease monitoring system in action,
and that system is working.
PUBLIC HEALTH LEADERSHIP
The Department of Health and Human Services (DHHS) anti-bioterrorism efforts

are focused on improving the nations public health surveillance network to quickly
detect and identify the biological agent that has been released; strengthening the
capacities for medical response, especially at the local level; expanding the stockpile
of pharmaceuticals for use when needed; expanding research on disease agents that
might be released, rapid methods for identifying biological agents, and improved
treatments and vaccines; and regulating the shipment of hazardous biological
agents or toxins.
As the Nations disease prevention and control agency, it is CDCs responsibility
on behalf of DHHS to provide national leadership in the public health and medical
communities in a concerted effort to detect, diagnose, respond to, and prevent ill-
nesses, including those that occur as a result of a deliberate release of biological
agents. This task is an integral part of CDCs overall mission to monitor and protect
the health of the U.S. population.
In 1998, CDC issued Preventing Emerging Infectious Diseases: A Strategy for the
21st Century, which describes CDCs plan for combating todays emerging diseases
and preventing those of tomorrow. It focuses on four goals, each of which has direct
relevance to preparedness for bioterrorism: disease surveillance and outbreak re-
sponse; applied research to develop diagnostic tests, drugs, vaccines, and surveil-
lance tools; infrastructure and training; and disease prevention and control. This
plan was developed with input from state and local health departments, disease ex-
perts, and partner organizations such as the American Society for Microbiology, the
Association of Public Health Laboratories, the Council of State and Territorial Epi-
demiologists, and the Infectious Disease Society of America. It emphasizes the need
to be prepared for the unexpectedwhether it is a naturally occurring influenza
pandemic or the deliberate release of smallpox by a terrorist. It is within the context
of these overall goals that CDC is preparing our Nations public health infrastruc-
ture to respond to potential future acts of biological terrorism. Copies of this CDC
plan have been provided previously to the Subcommittee. In addition, CDC pre-
sented in March a report to the Senate entitled Public Healths Infrastructure: A
Status Report. Recommendations in this report complement the strategies outlined
for emerging infectious diseases and preparedness and response to bioterrorism.
These recommendations include training of the public health workforce, strength-
ening of data and communications systems, and improving the public health sys-
tems at the state and local level.
CDCS STRATEGIC PLAN FOR BIOTERRORISM
On April 21, 2000, CDC issued a Morbidity and Mortality Weekly Report
(MMWR), Biological and Chemical Terrorism: Strategic Plan for Preparedness and
ResponseRecommendations of the CDC Strategic Planning Workgroup, which out-
lines steps for strengthening public health and healthcare capacity to protect the na-
tion against these threats. This report reinforces the work CDC has been contrib-
uting to this effort since 1998 and lays a framework from which to enhance public
health infrastructure. In keeping with the message of this report, five key focus
areas have been identified which provide the foundation for local, state, and federal
planning efforts: Preparedness and Prevention, Detection and Surveillance, Diag-
nosis and Characterization of Biological and Chemical Agents, Response, and Com-
munication. These areas capture the goals of CDCs Bioterrorism Preparedness and
Response Program for general bioterrorism preparedness, as well as the more spe-
cific goals targeted towards preparing for the potential intentional reintroduction of
smallpox.
167
Preparedness and prevention
CDC is working to ensure that all levels of the public health communityfederal,
state, and localcoordinate with the medical and emergency response communities
to deal with the public health consequences of biological and chemical terrorism.
CDC is creating diagnostic and epidemiological performance standards for state
and local health departments and will help states conduct drills and exercises to as-
sess local readiness for bioterrorism. In addition, CDC, the National Institutes of
Health (NIH), the Department of Defense (DOD), and other agencies are supporting
and encouraging research to address scientific issues related to bioterrorism. In
some cases, new vaccines, antitoxins, or innovative drug treatments need to be de-
veloped or stocked. Moreover, we need to learn more about the pathogenesis, epide-
miology, and clinical features of the infectious diseases which do not affect the U.S.
population currently. We have only limited knowledge about how artificial methods
of dispersion may affect the infection rate, virulence, or impact of these biological
agents.
In 1999, the Institute of Medicine released its Assessment of Future Scientific
Needs for Live Variola Virus, which formed the basis for a phased research agenda
to address several scientific issues related to smallpox. This research agenda is a
collaboration between CDC, NIH, DOD, and international partners, and is being un-
dertaken in the high-containment laboratory at CDC with the concurrence of WHO.
The research addresses: 1) the use of modern serologic and molecular diagnostic
techniques to improve diagnostic capabilities for smallpox, 2) the evaluation of
antiviral compounds for activity against the smallpox virus, and 3) further study of
the pathogenesis of smallpox by the development of an animal model that mimics
human smallpox infection. To date, genetic material from 45 different strains of
smallpox virus has been extracted and is being evaluated to determine the genetic
diversity of different strains of the virus. The NIH, with CDC and DOD collabo-
rators, has funded a Poxvirus Bioinformatics Resource Center (www.poxvirus.org) to
facilitate the analysis of sequence data to aid the development of rapid and specific
diagnostic assays, antiviral medicines and vaccines. A dedicated sequencing and bio-
informatics laboratory has been developed at CDC to help further these efforts. This
laboratory will also be used to help characterize other potential bioterrorism patho-
gens. A team of collaborating scientists has screened over 700 compounds for
antiviral activity against isolates of variola (smallpox) virus and other related
orthopoxviruses and have found several compounds which merit further evaluation
in animal models. Over 20 of the most promising compounds will be further tested
for antiviral activity in animal model systems. The identification of one currently
licensed compound with in vitro and in vivo efficacy against the smallpox virus has
led to the development of an Investigational New Drug (IND) application by NIH
and CDC to the FDA for use of this drug, cidofovir, in an emergency situation for
treating persons who are diagnosed with smallpox. In addition, CDC has included
the use of cidofovir in an existing IND to allow the emergency use of this medication
in the treatment of adverse reactions to smallpox vaccination. Researchers also have
been funded by NIH to design new anti-smallpox medicines and to create human
monoclonal antibodies to replace the limited supply of vaccinia immune globulin
that is needed to treat vaccine complications that arise during immunization cam-
paigns.
The Advisory Committee for Immunization Practices (ACIP) worked with CDC to
develop updated guidelines for the use of smallpox vaccine. These guidelines were
published in the MMWR in June 2001 and serve to educate the medical and state
and local public health community regarding the recommended routine and emer-
gency uses and medical aspects of the vaccine, as well as the medical aspects of
smallpox itself. Several infection control and worker safety issues were also ad-
dressed by the ACIP within the updated guidelines.
We are pursuing the development of additional smallpox vaccine with multiple
manufacturers in order to rapidly enhance our vaccine resource capabilities to re-
spond to a smallpox outbreak. We are also working to ensure that the stores of vac-
cine that we have in the United States currently are ready for use, including proto-
cols for emergency release and transportation of the vaccine. We have conducted po-
tency testing to and have confirmed that all currently existing lots are still potent.
On October 26, NIH began recruitment for a study to test Dryvax vaccine efficacy
undiluted, at 1:5 dilution, and at 1:10 dilution. Depending on the results of this
study, CDC will ensure availability of enough diluent to allow for the appropriate
dilution of vaccine. One study has already been completed which found that undi-
luted vaccine was effective 95 percent of the time, 1:10 dilution was effective 70 per-
cent of the time, and 1:100 was effective 20 percent of the time. CDC is in the proc-
ess of contracting with additional manufacturers to produce a total of 300 million
168
doses of vaccine by the end of next year. The President recently signed an Executive
Order that allows HHS to provide indemnification for the smallpox manufacturers.
Detection and surveillance
Because the initial detection of a biological terrorist attack will most likely occur
at the local level, it is essential to educate and train members of the medical com-
munityboth public and privatewho may be the first to examine and treat the
victims. For example, the Florida physicians ability to recognize a suspected case
of anthrax and his awareness of his role in reporting it to the local health depart-
ment was critical to our initial recognition of the current bioterrorist events. It is
also necessary to upgrade the surveillance systems of state and local health depart-
ments, as well as within healthcare facilities such as hospitals, which will be relied
upon to spot unusual patterns of disease occurrence and to identify any additional
cases of illness.
CDC is enhancing its national surveillance system for hospital-acquired infections,
dialysis surveillance, and healthcare worker safety surveillance into the National
Healthcare Safety Network (NHSN). NHSN, is a web-based tool for collecting and
communicating important clinical findings with healthcare facilities. Other partner-
ships with managed care and provider groups have proved invaluable for commu-
nicating recommendations during the recent bioterrorism response, and further ac-
tivities to improve detection of potential bioterrorist attacks through these partners
is planned.
CDC will provide terrorism-related training to epidemiologists and laboratorians,
emergency responders, emergency department personnel and other front-line health-
care providers, and health and safety personnel. CDC is working to provide edu-
cational materials regarding potential bioterrorism agents to the medical and public
health communities on its bioterrorism website at www.bt.cdc.gov.
Preparing CDC, state, and other professionals to respond to a smallpox bioter-
rorist threat or incident will revolve primarily around training three groups:
CDC Response Teams.CDC will begin conducting a 3-day course this month
for personnel comprising teams that will be deployed to respond to an incident.
Training will cover technical issues regarding the disease and the vaccine, oper-
ational issues such as isolation and quarantine, surveillance, and communica-
tions, and an introduction to CDCs response plan. A scenario-based exercise
will be included.
State Health Representatives.CDC is developing a 34 day training course for
health representatives from U.S. states and territories who would be involved
in responding to a smallpox bioterrorist incident. The objective of this training
is that each state/territory produce a Smallpox Response Plan that will be com-
patible with CDCs national plan. Approximately 150 representatives (up to 3
from each state/territory) will be trained.
Clinicians.On December 13, CDC will conduct a live satellite broadcast titled
Smallpox: What Every Clinician Should Know. This training session is targeted
toward physicians, nurses, and others who may be called on to identify and
handle smallpox cases and to deliver smallpox vaccine. It will cover topics such
as smallpox epidemiology, diagnosis, laboratory confirmation, vaccination, and
management of suspected cases. After the broadcast, the course will be con-
verted to a web-based format and self-instructional videotapes.
Concurrent with the satellite broadcast, a train the trainer session will be
held for infectious disease experts at academic institutions and staff at national
provider organizations. The goal is to enable representatives from these groups
to disseminate smallpox response training to their peers throughout the medical
community. Followup sessions will be held through April/May 2002.
CDC is also producing a variety of educational materials to be used by clini-
cians who may be involved in smallpox identification, care, or vaccination.
These materials include an interactive CDROM that will contain technical in-
formation and practice exercises, fact sheets, aids to smallpox diagnosis, and a
smallpox Vaccine Information Statement.
Diagnosis and Characterization of Biological and Chemical Agents
To ensure that prevention and treatment measures can be implemented quickly
in the event of a biological or chemical terrorist attack, rapid diagnosis is critical.
CDC has developed guidelines and quality assurance standards for the safe and se-
cure collection, storage, transport, and processing of biologic and environmental
samples. In collaboration with other federal and non-federal partners, CDC is co-
sponsoring a series of training exercises for state public health laboratory personnel
on requirements for the safe use, containment, and transport of dangerous biological
agents and toxins. CDC, also in cooperation with the Association of Public Health
169
Laboratories (APHL) and the National Laboratory Training Network (NLTN) have
sponsored a hands-on laboratory course for public health microbiologists. In con-
junction with the course, CDC produced two videos that were distributed to the par-
ticipants as well as to members of the NLTN. The participants in this course are
now using these videos and the other materials developed by CDC to train other
laboratorians in their states. CDC is also enhancing its efforts to foster the safe de-
sign and operation of Biosafety Level 3 laboratories, which are required for handling
many highly dangerous pathogens. Furthermore, CDC is developing a Rapid Toxic
Screen to detect peoples exposure to 150 chemical agents using blood or urine sam-
ples.
Response
A decisive and timely response to a biological terrorist event involves a fully docu-
mented and well rehearsed plan of detection, epidemiologic investigation, and med-
ical treatment for affected persons, and the initiation of disease prevention meas-
ures to minimize illness, injury and death. CDC is addressing this by (1) assisting
state and local health agencies in developing their plans for investigating and re-
sponding to unusual events and unexplained illnesses and (2) bolstering CDCs ca-
pacities within the overall federal bioterrorism response effort. CDC has formed and
trained multiple outbreak response teams that are available for rapid deployment
to assist state and local authorities deal with outbreaks due to any potential bioter-
rorism agent including smallpox. CDC is formalizing current draft plans for the no-
tification and mobilization of personnel and laboratory resources in response to a
bioterrorism emergency such as smallpox, as well as overall strategies for vaccina-
tion, and development and implementation of other outbreak control measures such
as isolation and quarantine measures. In addition, CDC is developing national
standards to ensure that respirators used by first responders and by other
healthcare providers responding to terrorist acts provide adequate protection
against weapons of terrorism.
Hospitals are critical in the response to bioterrorist attacks. CDC is collaborating
with various healthcare associations and infection control societies to better prepare
for potential bioterrorist events. Various hospital-based syndromic surveillance ac-
tivities in regions affected by anthrax exposures have provided critical information
on possible cases. Through provider-based sentinel networks, CDC has been able to
communicate with infectious disease clinicians, infection control professionals, and
other key clinical participants in bioterrorism preparedness and response.
Communication Systems
Rapid and secure communications are crucial to ensure a prompt and coordinated
response. Thus, strengthening communication among clinicians, emergency rooms,
infection control practitioners, hospitals, pharmaceutical companies, and public
health personnel is of paramount importance. To this end, CDC is making a signifi-
cant investment in building the nations public health communications infrastruc-
ture through the Health Alert Network (HAN). HAN is a nationwide program to es-
tablish the communications, information, distance-learning, and organizational in-
frastructure for a new level of defense against health threats, including bioter-
rorism. Currently, 13 states are connected to all of their local health jurisdictions;
50 states have begun connecting to local providers as well; and CDC is also directly
connecting to groups, such as the American Medical Association, to cast a broad net
of coverage. CDC has also established the Epidemic Information Exchange (Epi-X),
a secure, Web-based communications system that provides information sharing ca-
pabilities to state and local health officials. CDC also provides timely satellite broad-
cast and web-broadcast training through the Public Health Training Network. For
example, on October 18, CDC experts shared information on anthrax with physi-
cians, hospitals, and other healthcare providers across the country via a satellite
broadcast, Anthrax: What Every Clinician Should Know. Part II of this program is
scheduled for this week and will present an update on clinical guidelines and proce-
dures for the early recognition, diagnosis, treatment, and reporting of anthrax expo-
sure.
Accurate and up-to-date information helps calm public fears and limit collateral
effects of the attack. CDC communicates with the public directly through its website
on emergency preparedness and through a public inquiry telephone and email sys-
tem, which, since the recent attacks, has responded to hundreds of questions daily.
In addition, CDC communicates to the public by releasing daily updates to the news
media, answering inquiries from the press and providing medical experts for inter-
views.
170
THE NATIONAL PHARMACEUTICAL STOCKPILE
Another integral component of public health preparedness at CDC has been the
development of a National Pharmaceutical Stockpile (NPS), which is mobilized in
response to an episode caused by a biological or chemical agent. The role of the
CDCs NPS program is to maintain a national repository of life-saving pharma-
ceuticals and medical material that can be delivered to the site or sites of a biologi-
cal or chemical terrorism event in order to reduce morbidity and mortality in a civil-
ian population. The NPS is a backup and means of support to state and local first
responders, healthcare providers, and public health officials. The NPS program con-
sists of a two-tier response: (1) 12-hour push packages, which are pre-assembled ar-
rays of pharmaceuticals and medical supplies that can be delivered to the scene of
a terrorism event within 12 hours of the federal decision to deploy the assets and
that will make possible the treatment or prophylaxis of disease caused by a variety
of threat agents; and (2) a Vendor-Managed Inventory (VMI) that can be tailored
to a specific threat agent. Components of the VMI will arrive at the scene 24 to 36
hours after activation. The NPS was mobilized for the first time on September 11,
when a 12-hour push pack was deployed to New York City, delivering 50 tons of
medical supplies to the site of the disaster in 7 hours. In addition, substantial quan-
tities of VMI were delivered to New York City within 24 hours. Components of the
VMI were deployed to various locations along the East coast to provide adequate
supplies of antibiotics as prophylaxis to individuals who were potentially exposed to
anthrax. CDC has developed this program in collaboration with federal and private
sector partners and with input from the states.
CHALLENGES
As has been highlighted recently, increased vigilance and preparedness for unex-
plained illnesses and injuries are an essential part of the public health effort to pro-
tect the American people against bioterrorism. Prior to the September 11 attack on
the United States, CDC was making substantial progress toward defining, devel-
oping, and implementing a nationwide public health response network to increase
the capacity of public health officials at all levelsfederal, state, and localto pre-
pare for and respond to deliberate attacks on the health of our citizens. The events
of September 11 were a defining moment for all of us, and since then we have dra-
matically increased our levels of preparedness and are implementing plans to in-
crease it even further.
CDC has been addressing issues of detection, epidemiologic investigation,
diagnostics, and enhanced infrastructure and communications as part of its overall
bioterrorism preparedness strategies. Based on federal, state, and local response in
the weeks following the events of September 11, and on recent training experiences,
such as the National TOPOFF event and the Dark Winter exercisewhich simu-
lated a terrorist release of smallpox virus, CDC has learned valuable lessons and
identified gaps that exist in bioterrorism preparedness and response at federal,
state, and local levels. CDC will continue to work with partners to address chal-
lenges such as improving coordination among other federal agencies during a re-
sponse and understanding the necessary relationship needed between conducting a
criminal investigation versus an epidemiologic case investigation. These issues, as
well as overall preparedness planning at federal, state, and local levels, require ad-
ditional action to ensure that the nation is fully prepared to respond to acts of bio-
logical and chemical terrorism.
Disease experts at CDC are developing strategies to prevent the spread of disease
during and after bioterrorist attacks. Specific components include (1) creating proto-
cols for immunizing at-risk populations; (2) isolating large numbers of exposed indi-
viduals; (3) reducing occupational exposures; (4) assessing methods of safeguarding
food and water from deliberate contamination; and (5) exploring ways to improve
linkages between animal and human disease surveillance networks since threat
agents that affect both humans and animals may first be detected in animals.
CONCLUSION
In conclusion, CDC is committed to working with other federal agencies and part-
ners as well as state and local public health departments to ensure the health and
medical care of our citizens. We have made substantial progress to date in enhanc-
ing the nations capability to prepare for and respond to a bioterrorist event, but
there is much more to be done. The best public health strategy to protect the health
of civilians against biological terrorism is the development, organization, and en-
hancement of public health prevention systems and tools. Priorities include
strengthened public health laboratory capacity, increased surveillance and outbreak
171
investigation capacity, and health communications, education, and training at the
federal, state, and local levels. Not only will this approach ensure that we are better
prepared for deliberate bioterrorist threats, but it will also enable us to recognize
and control naturally occurring new or re-emerging infectious diseases. A strong and
flexible public health infrastructure is the best defense against any disease out-
break.
Thank you very much for your attention. I will be happy to answer any questions
you may have.
Senator HARKIN. Dr. LeDuc, thank you very much for your testi-
mony.
Now we turn to Dr. Friedman. Dr. Friedman.
STATEMENT OF MICHAEL FRIEDMAN, M.D., CHIEF MEDICAL OFFICER
FOR BIOMEDICAL PREPAREDNESS, PHARMACEUTICAL RE-
SEARCH AND MANUFACTURERS OF AMERICA
Dr. FRIEDMAN. Thank you, Mr. Chairman, Senator Byrd, Senator
Specter, Senator Stevens. On behalf of the men and women who
are the member companies in the Pharmaceutical Research and
Manufacturers of America, I thank you for this opportunity to de-
scribe our deep commitment to the national effort to counter bioter-
rorism and specifically our response to smallpox.
In my new position I am focusing on ways in which we can co-
ordinate and facilitate the pharmaceutical industrys efforts with
government and with others to protect the public health. This is a
time of unprecedented public health threats and the pharma-
ceutical industry is completely committed to the government and to
the American people to counter this threat. We are already work-
ing in a variety of ways to address these issues.
We are uniquely qualified to do so. Our scientists have the inge-
nuity, the energy, the knowledge, the capability, and the commit-
ment to meet the threat. We are providing antibiotics. We will be
providing vaccines. We are making our company scientists avail-
able. We are offering government all the tangible resources that we
can to assist. The reason we are doing this is because its our clear
duty as American citizens.
We have made many tangible and important contributions, and
that is outlined in my written testimony and in the interest of time
I will not go through all of those here. Suffice it to say that within
hours of the terrorist attack on September 11 our companies began
responding in a variety of tangible ways to try and help, and that
continues today.
In addition, we reached out to the President, to the Secretary of
Health and Human Services, to Governor Ridge and the Office of
Homeland Security, to ask them what can we do to complement
government activities and to make a more integral overall defense
of the Nation. We formed within our organization our own emer-
gency preparedness task force to direct our efforts at bioterrorism,
both from an administrative point of view and a separate com-
mittee on a scientific level to try and do that.
We have had the privilege of meeting twice with Secretary
Thompson very recently, once with Governor Ridge, to discuss very
specifically identifying the priority needs that the government has
and how we can help address those things. We are committed to
working with organizations represented on this panel and other or-
ganizations within the government to fully address these issues.
172
It has been pointed out to you that the global success of vaccina-
tion has caused the smallpox threat to diminish until just very re-
cently. Let me outline, if I may, very quickly what several of our
companies are engaged in at this moment. Initially, several of our
companies were contacted by the government in late September
about the feasibility of manufacturing a new version of smallpox
vaccine. Today I am pleased to report that they have made really
extraordinary efforts to respond in record time.
Even before the formal request for information was issued, they
had brought to bear considerable resources to this project, re-
directing other priorities and surveying their existing technical ca-
pabilities, recognizing what would be needed. They put in place
their efforts to respond. Within a week of receiving the initial re-
quest, our companies were here in Washington, presenting to a dis-
tinguished panel of experts formed by the government what our ca-
pabilities for each of those companies might be in the response to
that initial request.
This has been a herculean effort. Normally it takes many years
to produce a new vaccine, but the government needs it more quick-
ly. They have said that their expectation is 300 million doses, as
Dr. Fauci has mentioned, produced within 1 year. This is an ex-
traordinary effort. We are up to this effort and our individual com-
panies are prepared to do what is necessary.
A new vaccine will be needed. New technology will be employed.
It will not be the old vaccine produced in the old way. That rep-
resents a number of challenges. But I was astonished to learn that
if you just add up the number of years of experience that the four
companies within our organization bring to this problem, it is 400
years of combined experience, and that is a tremendous resource
that we can offer to the American public.
We recognize that there are a number of specific issues and prob-
lems that will need to be dealt with. This contracting process is
still ongoing and so I cannot speak to any of the specifics. But our
companies are fully committed to this and we are working well
with government agencies.
The government is best able to assess and identify the risks of
various possible agents. Our responsibility, as vibrant and vigorous
research organizations, is to bring about those treatments to ad-
dress those specific needs. We feel it is a privilege to be able to
serve in that capacity.
PREPARED STATEMENT
I understand that there may be a number of questions that you

would like to ask. We would be very pleased to try and answer
those. Uniquely, the pharmaceutical industry has what it takes to
win this bioterrorism war, and we are fully engaged in this.
PREPARED STATEMENT OF DR. MICHAEL FRIEDMAN
Mr. Chairman and Members of the Subcommittee: On behalf of the Member com-
panies of the Pharmaceutical Research and Manufacturers of America (PhRMA), I
want to thank you for providing me the opportunity to testify on the pharmaceutical
industrys response to bioterrorism, and specifically its response to small pox. My
name is Michael Friedman and I am the Chief Medical Officer for Biomedical Pre-
173
paredness at PhRMA, a new position created to help coordinate the pharmaceutical
industrys efforts to protect public health. I am a board certified internist and med-
ical oncologist and am currently a Senior Vice President at Pharmacia Corporation.
Prior to joining Pharmacia, I spent four years at the Food and Drug Administration
(FDA), including more than a years service as Acting Commissioner. In addition to
my time at the FDA, I also spent 12 years at the National Cancer Institute, and
8 years as a faculty member teaching and conducting research at the University of
California, San Francisco Medical School. I also served on active duty for many
years in the Public Health Service, holding the rank of Rear Admiral and Assistant
Surgeon General, and continue today as a reserve officer.
In this time of unprecedented public health threats, the pharmaceutical industry
is united with the American people and with our government. We are committed
to doing everything possible to help protect the public health. Our scientists have
the innovation, the energy, the cutting-edge knowledge, the capability, and the com-
mitment necessary to meet the bioterrorist threat. From providing antibiotics and
vaccines, to making available scientists within our companies, we are offering the
government our resources to meet the public health threats of bioterrorism. We are
here to continue our partnership with the federal government and with the Amer-
ican people in meeting these challenges. This is our first duty as Americans.
INDUSTRYS RESPONSE TO EVENTS OF SEPTEMBER 11
Let me briefly summarize the pharmaceutical industrys initial response to the

tragic events of September 11, a day that none of us will ever forget. Within hours
of the terrorist attacks, our companies responded by supplying:
Transportation/Delivery Support to Hospitals and Medical FacilitiesRefrig-
erated Trucks
Helicopter Support
18-wheeler transports for military and medical supplies
Fire Trucks
Ambulances
Medicines
Pain medication
Antibiotics
Analgesics
Anti-fungals
Eye lubricants
Saline
Infant Formula
Anesthesia products
Alcohol swabs
Bags of dextrose solution and sodium chloride
Wound care and personal care products in disaster-care modules delivered by
mid-afternoon Tuesday to New York area hospitals
Medical Equipment
Masks
Tyvek suits
Respirators with cartridges
IVs
Tubing
Work gloves
Latex gloves
Aid for burn victims
On the night of September 11th, Novartis made a donation of their artificial
human skin, Apligraf Graftskin, for burn victims. Working closely with offi-
cials in New York and at the Department of Health and Human Services
(HHS) in Washington, they have provided technical medical support and en-
listed cars, vans and trucks to ship the skin to medical facilities. Additionally,
Novartis sent 20,000 bottles of eye solution for rescue workers.
In the immediate hours after the attack, Solvay obtained special Food and
Drug Administration (FDA) compassionate use approval to provide 2,088
bottles of burn cream that is currently in Phase III trials. Solvay worked
through the Centers for Disease Control and Prevention (CDC) in Atlanta to
arrange for shipment to New Yorks Presbyterian Hospital Burn Center by
Special FedEx truck and state police escort.
Blood supplies and blood donations
With the help of National Guard and police escorts, Abbott delivered critical
medical products throughout the day to all of the hospitals in the affected
174
areas that placed emergency orders. To address the blood shortage, Abbott
transported (by refrigerated truck) a supply of blood from the Chicago area
and Wisconsin blood banks to hospitals and medical centers in New Jersey
and New York area.
Clothing
To fire, police and other rescue workers
Financial Contributions
Our companies have donated over $80 million in cash to a variety of relief
efforts.
Immediately, our companies reached out to President Bush, Secretary Thompson,
Governor Ridge and others in government to ask what we could do. In addition,
PhRMA and its member companies quickly formed an industry Board-level Emer-
gency Preparedness Task Force to direct PhRMAs efforts on bioterrorism.
INDUSTRYS RESPONSE TO ANTHRAX
Just weeks ago, when stories first began breaking about cases of anthrax expo-
sure in Florida, the nation quickly became aware that Cipro, manufactured by a
PhRMA Member Company, Bayer, was the initial treatment of choice for anthrax
exposure. Let me briefly explain what several of our companies have done to specifi-
cally respond to fight anthrax:
Bayer has donated four million tablets of Cipro to HHS for emergency workers
on the frontlines and the postal workers who may have been exposed to an-
thrax-laden mail. They have also tripled production of Cipro to 15 million tab-
lets a week, ensuring that an ample supply of Cipro is available. They have
pledged to the U.S. government that they will produce 200 million tablets in
the next 90 days for its stockpile. Last, Bayer will sell Cipro to the government
at deeply reduced prices.
Abbott will supply the antibiotics Biaxin and erythomycin, if approved by the
FDA for the treatment of anthrax, free to the government for any victims. Ab-
bott is also sending shipments of its antibiotics to the Department of Defense
for U.S. military troops involved in the current effort.
Bristol-Myers Squibb will make its antibiotic Tequin available free to people in-
fected by or exposed to anthrax if the FDA approves its use against anthrax.
It will also consider sharing the Tequin license with the government or other
companies in the unlikely event the need should exceed the supply.
GlaxoSmithKline is working with the government on expeditious review of two
antibiotics, Amoxil and Augmentin, to be used in the treatment of anthrax. It
will make these medicines available to the government free of charge for indi-
viduals exposed to, or diagnosed with, anthrax.
Johnson & Johnson is seeking FDA approval of an existing antibiotic, Levaquin,
for the treatment of anthrax and will make up to 100 million tablets of the med-
icine available to the government free of charge.
Pharmacia Corporation will make available to the government free of charge an
antibiotic, Cleocin HCl, to treat anthrax infection, pending FDA approval for the
treatment of anthrax. Other Pharmacia antibiotics are also in laboratory testing
to determine efficacy against anthrax and other biological agents.
Pfizer has increased production of an antibiotic, Vibramycin, which is indicated
for the treatment of the cutaneous and inhalation forms of anthrax. Pfizer is
also in discussions with public health authorities regarding the possible utility
of the companys other human antibiotics. It has also pledged that it will make
no profit on medicines supplied to the government to fight bioterrorism.
Eli Lilly and Company will provide any of its antibiotics that are found to be
effective against anthrax at cost to victims of bioterrorism.
PH RMAS EMERGENCY PREPAREDNESS TASK FORCE ACTION
On October 19, 2001, PhRMAs Emergency Preparedness Task Force met with
Secretary Thompson to offer the industrys assistance in responding to the national
bioterrorism threats. By October 26, 2001, a follow-up meeting was held with Sec-
retary Thompson to continue sharing information and offering assistance.
As part of this meeting, we pledged to Secretary Thompson a wide array of sup-
port. In addition to the Task Force on Emergency Preparedness composed of indus-
try leaders, we also established a Bioterrorism Group of Scientific Experts composed
of leading scientists. Through the Task Force, the Bioterrorism Group of Scientific
Experts, and myself, we are offering our assistance to the United States Office of
Homeland Security, HHS, CDC and any other government agency that we are asked
to serve.
175
On October 31, 2001, our Emergency Preparedness Task Force met with Governor
Ridge to offer the industrys support in responding to bioterrorism threats.
In addition to pledging our leading scientists, several companies have stepped for-
ward with other offers of assistance, including:
Bristol Myers-Squibb will provide a dedicated antibioterrorism team of 2025
scientists specialized in anti-bacterial research who will initiate a multiprong
attack on the microbial weapons of bioterrorism. This team will purse research
under government direction and be fully funded by Bristol Myers-Squibb.
Merck-Medco will help state and federal authorities distribute antibiotics as
needed and will use its technology and expertise to transform stockpiles of
medicines into individual prescriptions. In New Jersey, Merck-Medco is on call
to assist the state in dispensing antibiotics to approximately 1,500 postal work-
ers, if needed.
Pfizer will put its extensive distribution network and warehouses at the dis-
posal of the government to ship medicines as needed.
Abbott is testing existing antibiotics to see if they would be effective against bio-
terrorism organisms and offering the assistance of its experts in infectious dis-
eases.
Johnson & Johnson will makes its scientific and research capabilities, manufac-
turing facilities, distribution channels and public information and education ca-
pabilities available to the government to deal with the crisis.
Aventis is offering technical and scientific support to the government in the de-
velopment of new vaccines and antibiotics manufacturing.
Pharmacia will provide confidential access to its internal scientific information,
animal model systems and chemical libraries to government officials.
The industry will make many of its manufacturing facilities and delivery sys-
tems available to the government, upon request.
INDUSTRYS RESPONSE TO SMALL POX THREAT
In addition to concerns over anthrax exposure, attention and concern is now being
focused on other diseases, such as small pox. As you know, the small pox vaccine
was credited with eradicating the disease on a global basis. As a result, public
health officials terminated the vaccination program within the U.S. in the 1970s.
Several of our companies were initially contacted by the U.S. government in late
September about the feasibility of manufacturing a new version of the small pox
vaccine. I am pleased to report that they have each made an extraordinary and un-
precedented effort, to respond in record time.
Even before the formal Request for Information (RFI), they brought resources to
bear on this project, redirecting priorities and surveying existing technical capabili-
ties that could be put into place to address this prospective public health emergency.
Within a week of receiving the RFI, our companies were here in Washington making
presentations to our nations public health authorities as to their individual capa-
bilities to produce the necessary amount of small pox vaccine.
This is no small task as the normal course of vaccine manufacturing scale-up is
a process than can take 58 years.
Our government has requested enough doses of vaccine for the entire U.S. popu-
lace (300 million doses) and to have this vaccine available within one year. Our in-
dustry stands ready to meet this request.
Since the vaccine has not been produced in nearly a quarter of a century, the
United States only has a relatively small amount of this vaccine on hand. In addi-
tion, the manufacturing process by which that vaccine was made is not deemed ac-
ceptable by modern day standards. Rather than growing Vaccinia (the virus that the
small pox vaccine is based on) in cows, a new process of growing it in cell culture
must be scaled-up. Developing the appropriate cell culture system and manufac-
turing capabilities present challenges. However, our vaccine companies can and will
meet this challenge. Collectively they have hundreds of company-years of experience
in research, scaling up production, and manufacturing and distributing vaccines
against many major public health threats.
It is the pharmaceutical industry that manufactured the original small pox vac-
cine. They have developed numerous viral vaccines for prophylaxis against diseases
such as mumps, measles, rubella, polio, and hepatitis and have extraordinary expe-
rience in the type of large scale manufacturing operations that lead me to be opti-
mistic that this challenge can be met.
An initial assessment suggests that with extraordinary efforts and an unprece-
dented crash program, 300 million doses of Vaccinia could be available by the mid-
dle of next year. Of course, many tens of millions of doses could be available consid-
erably earlier.
176
There is no doubt that developing the capabilities to produce enough quantity in
a quick time frame will be a massive, unprecedented undertaking requiring compa-
nies to retool their production processes on a scale never previously contemplated.
Clearly a number of the critical issues will be addressed when the government
issues its formal Request for Proposal (RFP) that we understand will be forthcoming
shortly.
It is also vital that there be a concerted effort on the part of the FDA to work
with industry as this new vaccine is developed. FDA must provide swift and clear
guidance to any of the prospective manufacturers of this new small pox vaccine as
to the expected requirements for licensure. This is critical as the new process for
producing this vaccine is markedly different than the process used in the past.
There are two components to this. First, the new vaccine must be evaluated to en-
sure that it is as efficacious as the older, animal-sourced vaccine. This will require
some comparative clinical trials, which should be conducted on an expedited basis.
Second, the manufacturing facility or facilities will have to be inspected for manu-
facturing compliance. It is our assessment that the FDA has all of the requisite au-
thority to make this a priority.
NEXT STEPS
The U.S. government and the pharmaceutical companies have the same goal
protecting the public health. We will assist the government in any way we can to
protect the health of our nations citizens.
We are offering our assistance to the government to help educate consumers and
the medical community. We are in the process of establishing a consumer-friendly
web site to educate and inform the public. In a meeting with Governor Ridge earlier
this week, our companies also offered the use of their work forces, who meet and
visit with doctors on a regular basis, to be a tool the government can use to educate
doctors about potential public health threats related to bioterrorism.
We will also continue to do what we dodevelop new medicines. Today, there are
19 antibiotics and 42 vaccines currently in development, including vaccines for
AIDS, malaria and tuberculosis. Continuing research and development of new medi-
cines, both to conquer natural diseases and to assure that our countrys citizens
have the best possible defenses against bioterrorism. Our armed forces and public
safety workers are the nations first defense. Our countrys unparalleled scientific
capabilitiescharacterized by innovation, nimbleness and extraordinary creativity
in fighting diseasestand immediately behind them in protecting the public health.
Our government is in the best position to assess the risk of the use of threat
agents. This is a difficult task and I know that the health and defense authorities
are hard at work on it. We will make our expertise available to assist in designing
the right responses to threats. As needed steps are identified, we will do what is
necessary to respond, including making the best treatment options available.
CONCLUSION
As I said in the beginning of my testimony, the pharmaceutical industry is pre-

pared to do whatever it takes to win this war. We stand ready to work with the
government to identify and respond to threats. Our companies are eager to make
contributions to this effort, and we stand ready to be of service.
Americas pharmaceutical companies have always been there for our country at
times of national crisis. We provided Penicillin for our soldiers in WWII. We re-
sponded to the AIDS epidemic, and since the mid-1990s, when the first protease
inhibitor drugs were launched and combination drug therapy was introduced, the
U.S. death rate from AIDS has dropped 80 percent. We offered medicines, supplies,
and financial assistance within hours of the tragic events of September 11th. And
were here for our country again in this time of crisis.
Were in unchartered waters here. We anticipate that this is going to be a long
war. And well be here for the American people every step of the way. We have what
it takes to win this war on bioterrorismin terms of the innovation, the research,
the cutting-edge knowledge, and well do whatever it takes to get the job done.
Thank you.
Senator HARKIN. Thank you, Dr. Friedman.
Now we turn to Dr. Barry. Dr. Barry.
177
STATEMENT OF M. ANITA BARRY, M.D., M.P.H., DIRECTOR, COMMU-
NICABLE DISEASE CONTROL, BOSTON PUBLIC HEALTH COMMIS-
SION, AND MEMBER, NATIONAL ASSOCIATION OF COUNTY AND
CITY HEALTH OFFICIALS
Dr. BARRY. Good morning. Chairman Harkin, honorable com-
mittee members, thank you for inviting me to speak to you today
from the perspective of a major urban health department. My name
is Dr. Anita Barry and I am the Director of Communicable Disease
Control for the Boston Public Health Commission, in the City of
Boston, under the leadership of Mayor Thomas Menino.
I am speaking to you today on behalf of the Boston Public Health
Commission and also the National Association of County and City
Health Officials, or NACCHO. NACCHO represents the Nations
3,000 local health agencies and NACCHO members serve every day
on the front lines to protect the health of their local communities.
As you consider legislation related to bioterrorism and smallpox,
I offer you the realities of what dealing with smallpox on a local
level would entail. While we have all learned a great deal in re-
sponding to anthrax-related bioterrorism, smallpox would be very
different. It is highly infectious and can be spread person to person,
making it a global as well as a local public health threat.
Thus far, proposals put forward by the administration have fo-
cused primarily on creating more vaccines. With smallpox, all the
vaccine in the world is not going to do any good without the capac-
ity to distribute and administer this vaccine locally. One thing is
very clear. The current levels of staffing, planning, and prepared-
ness at the local level are not enough, even in cities that have initi-
ated bioterrorism preparedness.
Well before September 11, Boston began to prepare for the possi-
bility of a bioterrorist event. City public health officials and safety
personnel have participated in Federal emergency planning efforts
and have held tabletop exercises to develop city-specific plans. But
the recent cluster of anthrax cases, despite the fact that there have
been no anthrax cases in Boston, has illustrated the many chal-
lenges that bioterrorism presents. These challenges will be mag-
nified manyfold if the disease in question is smallpox, which can
be transmitted from person to person, instead of anthrax, which
cannot.
If presented with a smallpox case, what would a local health de-
partment do? We would first confirm the diagnosis as quickly as
possible. But once that happened, we would be faced with a myriad
of issues, such as appropriate care for and isolation of the infected
individual, identification of the source of infection to determine if
others were at immediate risk, identification of exposed individuals
who need smallpox vaccination to prevent disease, provision of clin-
ical guidelines for other health care providers in the area to enable
them to provide both the best individual and public health care,
and the launching of a massive educational campaign for both the
public and the health care community.
The local health department would quickly be contacted by the
hospital for advice on infection control. We would be asked to per-
form epidemiologic analysis to identify those at risk in the commu-
nity. We would have a flood of calls from health care providers con-
cerned that they have the next smallpox case. Citizens would turn
178
to their local health department with the expectation that vaccina-

tion clinics would be widely available ASAP. And all the while, the
media would be contacting us to report to the waiting public.
Can a local public health department meet this challenge? I be-
lieve that it can, but this smallpox threat highlights the fact that
local health departments desperately need increased Federal sup-
port in order to plan for and respond to a major infectious disease
event like smallpox.
In the communicable disease control program in Boston, we have
currently one infectious disease physician and a few nurses, which
is not enough for a city with a population of 600,000 residents and
a weekday work force of 1.2 million people. Many times this num-
ber of clinical and public health personnel would be needed to deal
with smallpox, as well as other infections such as meningitis that
also urgently demand our attention.
At the most recent Boston Surveillance Task Force on Bioter-
rorism meeting held last Monday, hospitals were already asking for
infection control guidelines related to smallpox. Questions about
the imposition and enforcement of quarantine have already sur-
faced. From my perspective, voluntary in-home quarantine with ap-
propriate support, such as the delivery of medical information,
food, and medication, is our most realistic option. But depending on
the number of cases, a quarantine facility may need to be set up
and staffed as an option for those unable to stay at home.
The Federal Centers for Disease Control and Prevention plays a
key role in providing technical assistance of the highest quality.
However, expediting direct access to this expertise for local health
departments should be a top priority. Already strained State health
departments should not have to act as a liaison in this process.
Last week, Boston Mayor Thomas Menino and city public health
and safety officials joined mayors from across the country to dis-
cuss local preparedness at the U.S. Conference of Mayors Emer-
gency Safety and Security Summit. The following recommendations
include public health steps urged by the U.S. Conference of May-
ors. These action steps will go a long way to help local public
health departments effectively carry out our jobs to protect public
health in the event of smallpox or another bioterrorist event.
First, local health departments should be represented at the
table at national emergency planning. The Director of Homeland
Security should immediately establish a permanent commission in-
cluding mayors, local public health officials, and local safety offi-
cials. Local officials are on the front lines of homeland security and
it is essential to forge direct lines of communication.
Second, the technical capabilities and communications infrastruc-
ture of local health departments need to be improved. All local
health departments should have access to communications systems
to receive accurate and timely information from State and Federal
authorities. We strongly support full funding and expansion of the
Health Alert Network.
Third, Federal agencies should direct significant
Senator HARKIN. Dr. Barry, could you please sum up, please.
Dr. BARRY. I am. Direct more funding to local communities. Too
often, local health departments are left out of the equation, but we
bear the burden of the front line response.
179
PREPARED STATEMENT
In closing, I would like to thank Senators Harkin, Specter, Byrd,

and their colleagues, including Senator Kennedy, for recognizing
the importance of funding for bioterrorism preparedness, and I
would encourage you, as you go forward, to direct funding to those
on the front lines, the local health departments.
PREPARED STATEMENT DR. ANITA BARRY
Chairman Harkin, Honorable Committee Members, thank you for inviting me
here to speak to you today from the perspective of a major urban health depart-
ment. My name is Dr. Anita Barry. I am the Director of Communicable Disease
Control for the Boston Public Health Commission, the health department for the
City of Boston, under the leadership of Mayor Thomas Menino. I am speaking today
on behalf of the Boston Public Health Commission and also the National Association
of County and City Health Officials (NACCHO). NACCHO represents the nations
3,000 local public health agencies. NACCHO members serve every day on the front
lines to protect the health of their communities.
As you consider legislation related to bioterrorism and smallpox, I offer you the
realities of what dealing with smallpox at the local level would entail. While we
have all learned a great deal in responding to anthrax related bioterrorism, small-
pox would be very different. It is highly infectious and can be spread person-to-per-
son, making it a global as well as a local health issue. Thus far, the proposals put
forth by the Administration have focused primarily on creating more vaccines. With
smallpox, all the vaccine in the world isnt going to do any good without the capacity
to distribute and administer vaccine locally. And one thing is very clear: the current
levels of staffing, planning, and preparedness at the local level are not enough, even
in cities that have initiated bioterrorism preparedness.
Well before September 11, Boston began to prepare for the possibility of a bioter-
rorist event. City public health and safety personnel have participated in federal
emergency planning efforts and have held tabletop exercises to develop city specific
plans. But the recent cluster of anthrax casesdespite the fact that there have been
no anthrax cases in Bostonhas illustrated the many challenges that bioterrorism
presents. These challenges will be magnified many fold if the disease in question
is smallpoxwhich can be transmitted from personinstead of anthraxwhich can-
not.
If presented with a smallpox case, what would a local health department do? We
would first confirm the diagnosis as quickly as possible. But once that happened,
we would be quickly faced with a myriad of issues, such as:
appropriate care for and isolation of the infected individual;
identification of the source of infection to determine if others were at immediate
risk;
identification of exposed individuals who need smallpox vaccination to prevent
disease;
provision of clinical guidelines for other health care providers in the area to en-
able them to provide the best individual and public health care;
launching of a massive educational campaign both for the public and the health
care community.
The local health department would quickly be contacted by the hospital for advice
on infection control. We would be asked to perform epidemiologic analysis to identify
those at risk in the community. We would have a flood of calls from health care
providers concerned that they have the next smallpox case. Citizens would turn
to their local health department with the expectation that vaccination clinics would
be widely available ASAP. And all the while, the media would be contacting us to
report to the waiting public.
Can a local public health department meet this challenge? I believe it can, but
the smallpox threat highlights the fact that local health departments desperately
need increased federal support in order to plan for and respond to a major infectious
disease event such as smallpox. In the Communicable Disease Control Program at
the Boston Public Health Commission, we currently have one Infectious Disease
physician and a few nursesnot enough to address a major infectious disease emer-
gency in a city with 600,000 residents and a workday population of 1.2 million.
Many times this number of clinical and public health personnel would be needed
to deal with smallpox as well as other infections such as meningitis that urgently
demand our attention.
180
At the most recent Boston Surveillance Task Force meeting held last Monday,
hospitals were already asking for infection control guidelines related to smallpox.
Questions about the imposition and enforcement of quarantine have already sur-
faced. From my perspective, voluntary-in home quarantine with appropriate support
(such as delivery of health information, food, and medication) is the most realistic
option. But depending on the number of cases, a quarantine facility may need to
be set up and staffed as an option for those unable to stay at home.
The federal Centers for Disease Control and Prevention plays a key role in pro-
viding technical assistance of the highest quality. However, expediting direct access
to this expertise for local health departments should be a top priority. Already
strained state health departments should not have to act as a linkage in this proc-
ess.
Last week, Boston Mayor Thomas Menino and City public health and safety offi-
cials joined mayors from across the country to discuss local preparedness at the U.S.
Conference of Mayors Emergency, Safety, and Security Summit. The following rec-
ommendations include public health steps urged in the U.S. Conference of Mayors
National Action Plan for Safety and Security in Americas Cities. These action steps
will go a long way to help local health departments effectively carry out our jobs
to protect the public health in the event of smallpox or other bioterrorist incident:
1. Local public health departments should be represented at the table in national
emergency planning. The Director of Homeland Security should immediately estab-
lish a permanent commission including mayors, local public health officials, and
local public safety officials. Local officials are on the frontlines of homeland security,
and it is essential to forge direct lines of communication among the Office of Home-
land Security, federal agencies, and local governments.
2. The technical capabilities and communication infrastructure of local health de-
partments need to be improved. All local health departments should have access to
communications systems to receive accurate and timely information from state and
federal authorities. We strongly support full funding and expansion of the Health
Alert Network.
3. Federal agencies should direct significantly more funding to local communities.
National public health organizations recommend that at least $835 million of the
emergency bioterrorism funding request go directly to local and state health depart-
ments. Local communities must receive a significant portion of that funding. Too
often, local health departments are left out of the equation, but we bear the major
burden of front line response. For example, in Boston, the health department antici-
pates spending at least $700,000 by the end of this fiscal year on bioterrorism-re-
lated emergency medical service response and the surveillance, communication, and
coordination activities of the communicable disease program.
4. Federal funding should be flexiblewe need to track and respond to a range
of public health concerns, including bioterrorist agents as well as influenza and
other emerging problems.
In closing, I again thank Chairman Harkin and the Committee for inviting me
to speak on behalf of local health departments and NACCHO. I would be pleased
to provide any further information in the future.
Senator HARKIN. Thank you, Dr. Barry. Thank you all.
I will turn to Senator Byrd first for questions and then Senator
Stevens. But before I do, Senator Byrd, just listening to these wit-
nesses, I thought of comparing our public health officials and our
public health infrastructure in America, to our military overseas.
If I were to do so, after listening to these people, I would say that
if you put it in military terms, our troops are ill-trained, our radar
is out of date, and we are short on ammunition with our public
health in America. That just seems to me what I am hearing here.
I turn to you, Senator Byrd, for your comments.
Senator BYRD. In other words, as Oliver Twist said, Heaven is
a long way off. We are coming up pretty short.
Well, I thank you, Mr. Chairman, again. I thank Senator Ste-
vens. I am the 23rd chairman of the Senate Appropriations Com-
mittee. Now, remember that. There is the best chairman. I have
served with a lot of good chairmen on the Appropriations Com-
mittee. Where MacDonald sits, there is the head of the table. There
181
is MacDonald, Senator Stevens, my colleague. As far as I am per-

sonally concerned, he is the best chairman I have ever served with.
Now, this is a fine panel, an extraordinarily fine panel. It seems
to me that the emphasis here mostly is on building our State and
local health departments so that they will be able to respond, so
that they will be able totheir labs, building their labs, enhancing
their labs, so that they will be able to recognize a variety of patho-
gens, be able to recognize these pathogens.
I would wager that there are very, very few doctors in the United
States who have ever seen a case of smallpox, very few. Therein
lies a great need here, a need to be able to recognize smallpox and
other bioterrorism pathogens quickly and then, as has been said
here, be able to spread the word and be able to take action, be able
to isolate and so on.
So let me ask my questions all at once. I have about three or four
questions. I will make it easy for you on the panel to answer these
questions. I am from a rural State. I say to Dr. Barry, with all re-
spect to the great urban communities of this country: God made
the country and man made the town. Now, I am from a rural State.
Thank God for that. A small State, a rural people, and my prob-
lemsmy questions concentrate perhaps on the rural areas.
We all recognize the need, the desperate need, to strengthen the
resources of our State and local health agencies. But I fear that one
problem may severely limit that effort, namely the critical shortage
of well-trained doctors and nurses in our rural areas. So what can
NIH or CDC do to bridge this gap in times of medical emergencies?
That is question No. 1.
Question No. 2, particularly to Dr. LeDuc. You spoke of the
CDCs high tech communications toolsthe Internet, email, and so
forth. But so many rural health departments do not have access to
these communications resources. What is the CDC going to do, and
what does it recommend that we do, as members of this panel to
overcome this gap?
As we contemplate the dark winter of our discontent, should
some medical or emergency workers be vaccinated immediately?
Finally, will the decision to produce so many doses of the vaccine
fuel public demand for a potentially hazardous mass immunization
campaign? You have indicated that there is some toxicity side ef-
fects. Let me speak of one. What happens to those who have asth-
ma, who already have lung diseases, and shortage of capacity, and
so on?
That is my contribution, Mr. Chairman. I hope that Dr. LeDuc
would begin because I mentioned him specifically.
Dr. LEDUC. Thank you, sir, for those very thoughtful questions.
Let me address the specific question you asked about communica-
tions in the rural area. It is our plan to develop the Health Alert
Network to the local area, to the county level, in all States, and I
think we are well on the way to doing that.
I can get back to you for the recordwell, maybe I can get to you
right now. We are making progress in getting that to all the local
county levels. I do not know exactly what the implementation scale
is today, but that clearly is one of our highest priorities, especially
now that the need is so apparent.
Senator BYRD. Dr. Fauci.
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Dr. FAUCI. The question that I could address, Senator Byrd, of

the few that you asked is one that is quite relevant and we do need
to address it. It is the question of what we call preemptive vaccina-
tion, because a lot of people are asking that. We are now on a crash
course, as it were, to get enough vaccine to be able to vaccinate the
entire population of the United States if necessary.
The public health approach to the identification of a case or cases
of smallpox in West Virginia, for example, if that happened, would
be to do the approach that you heard mentioned here: you identify,
isolate, quarantine if necessary, contact, trace, and vaccinate peo-
ple in an area that could have come into contact with smallpox
virus. That is the classic public health approach to smallpox and
is the way that eradication of smallpox was actually accomplished,
particularly in developing nations, the strategy that Dr. Bill Foege
and others had developed many years ago.
If you have multifocal involvement, where you have many cases
in many different places, then you think in terms of a broader,
more massive vaccination. I can tell you here today that when we
get, and even before we get, enough vaccine to execute something
like a preemptive vaccination, a decision needs to be made in a way
that is serious and well thought out. The American public needs to
hear about this and it needs to be transparent.
Senator BYRD. But what are some of the toxicities that I have
heard about?
Dr. FAUCI. The toxicities are as follows, and then perhaps Dr.
LeDuc can amplify on them. The toxicities we know come from ex-
perience decades ago with vaccination, and there are a few studies
that vary with regard to toxicities. For example, the most recent
study that we have from 1968 data indicates that for every million
people who are vaccinated there will be anywhere from one to four
or five deaths associated with the vaccine.
That is generally due to a fulminant response such as encepha-
litis associated with the vaccination or generalized vaccinia. They
are uncommon, but when they occur they are serious. This is rel-
evant to the point that I mention, that if you decide to preemp-
tively vaccinate you must weigh the risk-benefits. I believe this de-
bate is going to occur and it might even occur right here before this
committee when that time comes, about whether to do the classic
public health approach of trying to isolate the index cases or to
think ahead and preemptively vaccinate.
That is a debate that needs to occur in a transparent way for the
American people to understand it.
Senator BYRD. I thank you. I do not want to press this further.
I am sure that through the questioning of my colleagues here the
answers to some of the other questions about the need for more
nurses, more doctors, more emergency health responders who will
be able to recognize these various pathogens and laboratories en-
hanced so that they can recognize the early symptoms of these bio-
terrorist weapons.
Senator HARKIN. Thank you, Mr. Chairman.
Senator Stevens.
Senator STEVENS. Thank you very much, ladies and gentlemen.
My role here has predominantly been in defense, as I think you all
183
know. But my basic interests have been in medical research. I am

pleased to say Dr. Fauci spent one evening and tried to help edu-
cate me. I thank you for that.
But I am constrained to say that if we look at the recent history,
the Soviet Union imploded because of the fear of weapons we did
not have. I would hate to see us implode because we finance a
whole series of actions against fears that could not or would not
materialize.
Now, having said that, I would hope that we keep in mind we
are into some things that are not detectable. This is a detectable,
readily detectable disease if it comes to our community, is it not?
It will be readily detectable?
Senator BYRD. The record will not show the nodding of heads.
Dr. LEDUC. Yes, sir. There are virtually no clinically inapparent
infections. All infected people will be overt.
Senator STEVENS. I do not want to underestimate the severity of
this disease.
Senator HARKIN. Senator Stevens.
Senator STEVENS. Yes?
Senator HARKIN. Could you just yield on that for a little bit of
enlightenment on that?
People today do get chickenpox. Do you believe that there are
enough health professionals out there that would recognize the dif-
ference between smallpox and chickenpox before it got out of hand?
Dr. LEDUC. We have had experience addressing this very issue
quite recently and I can tell you that severe chickenpox is ex-
tremely difficult to differentiate from classic smallpox. This would
be a diagnostic dilemma.
Senator HARKIN. So then your question to Senator Stevens has
to be modified a little bit. You nodded your head and said yes, that
this is something that would be readily identifiable. But if it is con-
fused with chickenpox, which is rather benign, and is not treated
immediately as smallpox, then it could spread out of control very
rapidly.
Dr. LEDUC. Well, in fact we are approaching this problem from
two perspectives. There is an effective vaccine for chickenpox and
we are encouraging health providers to use this, so that we main-
tain a very high level of coverage for chickenpox immunization, so
that we have reduced the risk of having outbreaks of chickenpox.
Senator STEVENS. To show my age, although my senior colleague
is not very far off
Senator BYRD. Do not worry about it.
Senator STEVENS [continuing]. I recall very well both chickenpox
and smallpox in my community when I was a boy, and we all got
our vaccinations in school and they were automatic. That is an-
other subject, because I was raised by a Christian Science family.
So it was a real interesting life that I had.
But as a practical matter I would like to ask you just a couple
of questions and see if you can give us the answerthose of us who
are old enough to have lived through the seventies were vaccinated
for smallpox and I was vaccinated several times. None of those vac-
cinations have any effect today, is that correct? They are all ex-
pired?
184
Dr. FAUCI. I do not think we can say that, Senator Stevens. I

think we can say that from what we classically know about immu-
nology and response to vaccinations, that the immunity that you
and I got when we were children and vaccinated is almost certainly
diminished. We say waning immunity. I doubt, as an immunol-
ogist and as an infectious disease person, that that immunity is
gone, namely zero.
Senator STEVENS. That is my question, doctor. Can those that
were previously vaccinated be given a booster, as opposed to those
that have never been?
Dr. FAUCI. Yes.
Senator STEVENS. Can you stretch that supply out by saying, you
people that were vaccinated before, you get this vaccine; those that
have not, you get another?
Dr. FAUCI. No, because the booster for an already vaccinated per-
son, Senator, is exactly the same as a primary for a person who has
never been vaccinated.
Senator STEVENS. Then answer another question on an entirely
different subject. If an exposure of a community occurred on Mon-
day, how long would it be before a vaccination would not be effec-
tive on the populace? How soon do we have this vaccine available
to a community after exposure?
Dr. FAUCI. It is approximately 4 days, between 3 and 4 days. Ex-
perience tells you that, if you vaccinate an exposed person, you
could either prevent infection or significantly modify the disease
that that person has.
Senator STEVENS. My other question would be, how effective is
real quarantine of a community that has it?
Dr. LEDUC. I think quarantine would be very effective. Isolating
patients is what we do, for example, to control ebola outbreaks,
where we have no other tools. This interrupts transmission. If you
could isolate patients so that they do not come into contact with
susceptible individuals, then you can interrupt transmission. We
have lots of tools to do that. We can isolate them within established
hospital rooms under isolation conditions. We can vaccinate staff
even after, as Dr. Fauci said, even after they have been exposed.
So for example, the patient comes into the emergency room and
it is determined that that individual has smallpox; we could immu-
nize the attending physician and all those in contact with that pa-
tient within four days and certainly alleviate the symptoms and in
many cases protect from infection completely.
Senator STEVENS. About the exposure of our community in the
case of anthrax, it has obviously taken highly trained people who
can refine that product, deliver it without themselves being in-
fected. I have not seen any reports that people who handle it and
deliver it have been infected. This process involves a human being
with smallpox. Can it be delivered other than by a human being
who is infected?
Dr. LEDUC. I do not really have any information on delivery sys-
tems. Perhaps others do.
Senator STEVENS. Well, if you had a petri dish here and it
spilled, would I get exposed? Or does it take an infectious person
who breathes into the air that I breathe?
185
Dr. LEDUC. You could certainly get it from the virus itself in the
equivalent of a petri dish or from a clinically ill individual, that is
true. It could be concentrated. It could be disseminated by air.
Senator STEVENS. But I am looking to the question, how can we
protect the community against exposure? We have immigrants
coming in, we have people coming with visas. To our knowledge, we
have no cases of smallpox in the United States today, so this would
be something that would have to be imported, right?
Dr. LEDUC. There are no cases anywhere in the world today. The
disease has been eradicated, so the virus that causes the illness
only occurs in test tubes in stored stocks.
Senator STEVENS. I do not want to prolong it, either, but I think
we have a real problem in trying to assess as we go forward now
with this money we have available this year the priorities of where
we put the money. Very clearly, one of the basic priorities that I
have had is the research to determine what substances might be
used as weapons.
Dr. Fauci.
Dr. FAUCI. Senator Stevens, let me address directly the direction
I believe you were going in, about what we need to do, be it easily
recognizable or not, even if we were absolutely correct and expert
in recognizing a case of smallpox in this country. That would imme-
diately trigger the need and justification for having vaccine avail-
able, because just one case, even if you recognize it totally accu-
rately, tells you that smallpox has been introduced to our society
and we need to be prepared with a vaccine.
Senator STEVENS. How about a timetable on that, doctor? If you
have an exposure in West Virginia, how soon thereafter with the
community at large, the whole country, have to have vaccine if they
desired to have vaccine?
Dr. FAUCI. If you fulfilled the strategy of isolating the case and
it is only a West Virginia case, and do what I mentioned before
about identification, isolation, contact, tracing and vaccination
around the case, you can do that at the local level. If you had
multifocal cases, then it becomes very complicated.
There was an experiment done that I, interestingly, as a child
was part of. That was in 1947 in New York City. There was a mis-
diagnosis of a case of smallpox that was felt to be chickenpox. An
individual went into a hospital and exposed a number of people.
Twelve people were infected, 2 people died. The public health ap-
proach to that was exactly what we said. There was isolation, quar-
antine, and vaccination within a 2-week period of 6.3 million New
Yorkers, one of which was me at that time. That is how that poten-
tial epidemic was curtailed.
That is exactly what the first-line approach would be. The critical
issue is if it is a multifocal outbreak, where it is not just New York
City or West Virginia, that is the reason why we are talking about
the need to have smallpox vaccination on hand.
Dr. BARRY. Could I just clarify for my perspective as a local
health person. Let us say we have a case come in the Massachu-
setts General Emergency Room and the docs there immediately
recognize that this is smallpox and they call us at the local health
department. First of all, you have to realize that person has been
wandering around the city of Boston now for a number of days and
186
is infectious. So we on a local level are not only going to have to

be advising the hospital on types of isolation, but somehow we are
going to have to find the staff to try to interview and find out
where this person has been in the city.
So you have 4 days from the time you are exposed to get the vac-
cine and be protected. But we are not going to know where those
people are. We are going to have to find those people and we are
going to have to have pretrained staff who are going to know how
to deliver that vaccine. That is going to be a very challenging task
for a local health department.
Also, I have to comment on the issue of community-wide quar-
antine. I think that is going to be very difficult to do. I think we
are really going to have to look at building support structures for
people, allowing them to stay for the most part in their own homes.
Senator STEVENS. Doctor, respectfully, I have to tell you that if
someone is going to use this as a weapon, you are going to have
a peripatetic agent that will probably visit about 10 or 11 terminals
in 1 day or 2. I do not think that, if this is to be used as a weapon,
we can say it is going to be contained in Boston or Anchorage or
somewhere in West Virginia. A weapon is a weapon.
I go back where Dr. Fauci came. I believe in fully available vac-
cines, but I do not suspect this is going to be some disease that
springs out of someone having visited someplace in the world and
coming back with smallpox. This comes to us as a weapon and I
think we have to think of it as a weapon, not think of it as a public
health problem, respectfully. It will be dealing with a weapon, a
weapon delivered to our system which we must react to imme-
diately. That does not mean just one community; it means that the
Nation is the community.
Dr. BARRY. Oh, I certainly understand that, Senator. But I am
just trying to figure out literally step A to step B what is going to
happen to get us into that responding to, as you call it, weapons
mode. It is going to take a lot.
Senator STEVENS. It will, yes.
Thank you very much. I appreciate your courtesy to me. I am
late for another meeting, but I appreciate what you are doing.
Thank you.
Senator HARKIN. Thank you, Senator Stevens.
Senator Specter.
With respect to the issue of our preparedness, the testimony and
written statements point out that the vaccine will be available by
the end of next year, but what do we do now if something should
happen immediately? Dr. Friedman?
Dr. FRIEDMAN. If you will, sir, I think that the current stocks of
vaccines are the responsibility of the Centers for Disease Control.
Dr. LEDUC. Yes, sir, let me try to answer that for you. As Dr.
Fauci said, we have in place a little over 15 million doses of vac-
cine. That represents our immediate response capability. We have
already explored the possibility of diluting that and, for example,
as Senator Stevens said, if we think of this as being a formal mili-
tary attack, I think one of the first challenges or first requests we
are going to have is from the Department of Defense.
187
Senator SPECTER. Let me ask you if there is a way to dilute it,

which has been testified to, to increase it substantially, but what
can be done now to deal with the population in this country of 280
million people? This subcommittee is prepared to recommend, and
I think the Congress will accept, funding for whatever it takes. So
what can be done now to have enough vaccines for our entire popu-
lation?
Dr. LEDUC. We have already begun that process. As Dr. Fried-
man said, we have met with the major manufacturers. I can tell
you, it is a heartwarming experience to have each and every one
of these major firms come and say, we recognize this as a major
national crisis, we are here to help.
Senator SPECTER. Dr. LeDuc, we understand that the people are
willing to cooperate. The question is how fast can it be done. If
money were no objectif it was no object; we will make it subjec-
tive. If money was no object, how fast can it be done?
Dr. LEDUC. The fastest that we will have a full 300 million doses
for the entire population is roughly by the end of next year. Actu-
ally, it will be more towards the middle, third quarter of next year,
those vaccines.
Senator SPECTER. By the third quarter of 2001?
Dr. LEDUC. 2002.
Senator SPECTER. 2002.
Dr. LEDUC. Calendar year.
Senator SPECTER. Dr. LeDuc, that is not adequate.
Dr. LEDUC. That is as fast as it can be made. Now, let me ex-
plain also that this will be an increasing slope. In fact, we are al-
ready producing the vaccine, the new vaccine
Senator SPECTER. How soon can we have it, if not for 300 million
people, for 100 million people?
Dr. LEDUC. We are talking with the major manufacturers. Their
lot sizes are roughly 20 million doses. When they get going, they
produce these in a matter of a couple of weeks. It takes
Senator SPECTER. Dr. LeDuc, let me ask you to go back to the
drawing boards and you, Dr. Friedman, as to what can be done to
expedite it.
Dr. LEDUC. Sir, I think that we have pushed this system abso-
lutely as much as we can. I do not think that we can make it go
any faster than we already are.
Senator SPECTER. Well, let me ask you, notwithstanding that, to
go back to the drawing boards and let this subcommittee know
within a week what can be done with more intensity. We have
found a lot of lines that we can do more if cost is no object, a life
and death situation.
Dr. FRIEDMAN. Senator Specter, may I just interrupt for one mo-
ment, because I wanted to just give some amplifying remarks, if I
may, sir. Something unprecedented is being offered by our pharma-
ceutical companies. What they have said is, irrespective of the con-
tracting process, whoever gets that contract, the other companies
are willing to dedicate their scientists and their production facili-
ties in order to meet this need.
Now, there are other legal implications of that that have not
been fully explored. But when I say that our companies are pre-
188
pared to do things that have never been done before, that is what
I am talking about.
Senator SPECTER. Dr. Friedman, I understand that. I understand
that they understand it is an emergency. But the question is how
soon for 100 million people or how soon for 200 million people and
how soon for 280 million people. We know they are prepared to
move ahead, but how soon if cost is no object.
I want to turn now to the question of vaccination. Under normal
circumstances, you do not vaccinate because the risks of vaccina-
tion are higher than the risks of contracting smallpox. The Wash-
ington Post had last Sunday characterizing Smallpox may be the
scariest thing in the biowarfare arsenal. Specifically when the
Post writer Shannon Brownley comes down to the issue of vaccina-
tion, the statement is made: A biological attack with smallpox
virus, though perhaps not as unlikely as it was just weeks ago, is
still a low probability, high impact event.
The experts are said to be opposed to vaccination because of the
adverse consequences. Well, it seems to me that that is a valid con-
clusion under normal circumstances, when you take the likelihood
of bad reaction or even death. But I question that in the context
of a bioterrorist attack. Now, that is very, very hard to quantify,
but it seems to me as a matter of common sense that vaccination
may be preferable. But those odds are totally changed.
What about that, Dr. LeDuc? First of all, what are the risks with
vaccination? I had heard one out of 4,000 would result in death. Dr.
Fauci says no. What are the risks, Dr. Fauci?
Dr. FAUCI. There is a bracket depending on the study and the
bracket goes anywhere from one to six per million deaths. There
are a lot of serious complications that do not necessarily result in
death, but mortality is anywhere from one if you look at the 1968
study, or an early study, it goes up to six or so per million.
Senator SPECTER. So why not vaccinate if the risks are that pro-
portioned? Dr. Fauci?
Dr. FAUCI. As I said before, Senator Specter, I believe that we
should seriously consider that, depending upon what the risks are.
Right now the risk is unclear with regard to the unleashing of a
smallpox bioterrorism attack.
Senator SPECTER. Dr. Fauci, are the risks ever going to be other
than unclear?
Dr. FAUCI. If you have good intelligence or an index caselet me,
if you would permit me, Senator, to just very quickly go through
some scenarios. If you have very good intelligence and we know
there clearly is smallpox available and it will be used as a bioter-
rorism weapon, that weighs toward what you are alluding to. If
there is an index case, even if it is not in the United States, that
weighs a little bit more. If we have an index case, that makes it
very, very heavy.
So myself as a physician, as an infectious disease person, am not
at all against vaccination. But we need to weigh the risk-benefits
as they evolve. There is a risk, but it may be that those risks
should be acceptable. I would not deny that at all. It is entirely
conceivable that we will have to accept those risks and vaccinate
people. But at this point in time, given the uncertainty as to
whether or not there is even material available to mount a bioter-
189
rorism attack, we do not have the material yet, so we do not have

enough even if we wanted to vaccinate everyone.
As we get it, we need to sharpen the debate about whether or
not we should preemptively do it. So I think we are on the same
channel. You are not hearing me say that we should not do that.
Senator SPECTER. Well, I do not think that we are ever going to
have intelligence to tell us that a bioterrorist attack with smallpox
is imminent. If we could not find out that they were about to crash
into the World Trade Center and the Pentagon, we are not going
to find that out. Our intelligence, we just cannot rely upon our in-
telligence. So I think the time is upon us now to get the maximum
amount of vaccine available, which we have already discussed, and
then at a minimum to leave it up to people to make the decision
as to whether they want to be vaccinated.
That is not really a governmental decision. Tell the American
people what the risks are, have the vaccine available, and let them
make the decision.
Dr. FAUCI. That is an entirely reasonable approach.
Senator SPECTER. My judgment would be to have my four grand-
daughters vaccinated. It is one in a million that they are going to
have an adverse reaction. It is our job to get the vaccine available.
I do not think thatit is not your province to decide what the risk
factor is of bioterrorism. That is the province of the Department of
Defense or the Central Intelligence Agency, with perhaps some in-
puts from the Congress.
But you tell us what the risks are and get us the vaccine and
let us leave it up to the American people to make their choice.
Dr. FAUCI. What you say makes very good sense, Senator, and
as a matter of fact, my own children, I would take the risk of hav-
ing them vaccinated if given the choice of having it. So I agree with
you. I think that is something that should be discussed in detail
because it makes sense.
Senator SPECTER. Now we are on the same wavelength.
Dr. FAUCI. Yes, okay.
Senator SPECTER. Put aside the risk factor. We are not going to
figure that out any better than we know it now. Let us get the vac-
cine available and let us have the fathers and maybe even some
of the grandfathers make choices.
One more question to you, Dr. Barry. One infectious disease doc-
tor in Boston. How many in Philadelphia? I know you do not know
the answer to that, but what can you do? Or Pittsburgh or Harris-
burg or Russell, Kansas. What can you do to make more infectious
disease doctors available?
Dr. BARRY. Well, the issue is within the city health department.
There is one infectious disease doctor within the city health depart-
ment to deal with bioterrorism, meningitis, hepatitis, tuberculosis,
and what can you do? You can increase funding for local health de-
partments so they can hire people.
Senator SPECTER. Okay, that is the city health department, but
how about the medical personnel generally in Boston? There are
more infectious disease doctors?
Dr. BARRY. There are many excellent infectious disease doctors
in the city of Boston and they have been wonderfully cooperative
in working with us in our planning efforts. However, their focus is
190
not on public health. Their focus is dealing with their patients in

the hospital or in their practice.
Senator SPECTER. Have they been organized in the event of an
infectious disease bioterrorist attack?
Dr. BARRY. Yes. In fact, in 1999 we got about a $1 million grant
over 5 years from the Centers for Disease Control to develop a spe-
cialized surveillance system and to develop that system we created
a citywide task force that included emergency department and in-
fectious disease personnel from all the hospitals in Boston.
Senator SPECTER. Dr. Barry, would you provide to this committee
just what you have done there, how many infectious disease doctors
there are, what organization there is to pull them into a coordi-
nated response to an attack? I think that is something that we will
inquire of other cities, to see what assistance may be necessary.
Dr. BARRY. Sure, no problem. There are infectious disease soci-
eties.
EMERGENCY COORDINATION AMONG PHYSICIANS IN BOSTON
Emergency Department and Infectious Disease physicians from 9 Boston hospitals
as well as physicians from Boston Emergency Medical Services and the Massachu-
setts Department of Public Health are members of the Commissions Surveillance
Task Force. These doctors receive daily reports on emergency department and acute
care site volume, frequent clinical advisories from the Boston Public Health Com-
mission, and participate in regular Task Force meetings to monitor and improve the
Special Surveillance System.
The Boston Public Health Commission is also in close communication with the
Conference of Boston Teaching Hospitals, which receives the regular clinical
advisories and forwards these to member hospitals.
Surveillance Task Force physicians have worked with the Commission to develop
a train the trainer curriculum and implement a program to teach other physicians,
nurses and other health care workers about bioterrorism.
Despite intensive education, healthcare providers have relied on Dr. Barry, and
the Boston Public Health Commission for guidance on anthrax and other bioter-
rorism related issues. For example, physicians consult Dr. Barry regarding whether
a patients symptoms and exposure to a suspicious substance require antibiotic
treatment. In another case, a doctor called the Commission for guidance regarding
appropriate measures for a patient complaining of fever and pox. The Boston Public
Health Commission assisted in determining that the patient was suffering only from
chicken pox.
Dr. Barry also serves on the Public Health Executive Council of the Massachu-
setts Medical Society and has contributed to the development of educational mate-
rials as part of their education group.
We are continuing to discuss ways to better coordinate communication and re-
sponse efforts among the hospital and public health and public safety agencies of
the City. However in the event of a public health emergency, the Boston Public
Health Commission will have the primary responsibility for centrally coordinating
communication and response efforts.
Therefore, we need more clinical personnel in Boston Public Health Commission,
specifically the Communicable Disease Control program, which has played a unique
role in a public health crisis. To increase clinical personnel at a large city health
department, what is needed is simply additional funding.
Senator SPECTER. Do you have access to the information which
is in the hands of Federal authorities, or do you have a problem?
Local police departments are complaining that the FBI will not
share information.
Dr. BARRY. We have a lot of information available. I think some-
times it would be a little easier for local health departments to be
able to deal directly with the technical expertise available at CDC,
191
as opposed to having to almost always work through the State

health departments.
Senator SPECTER. Would you say in the event of bioterrorist at-
tacks with smallpox we need a massive education program?
Dr. BARRY. Yes.
Senator SPECTER. Should we not start that now?
Dr. BARRY. Yes. In fact, we have, as well as we can with our re-
sources, started. We have fact sheets developed on smallpox. We
have started to talk to health care providers as part of an edu-
cational series. But again, we have limited staff. We have started
this process, but we clearly need more to be able to finish it.
Senator SPECTER. Would you provide the information as to what
your educational program is?
Dr. BARRY. Certainly.
Senator SPECTER. That is something the subcommittee would
like to look at
Dr. BARRY. Certainly.
Senator SPECTER [continuing]. To see what funding is appro-
priate for you and for other similarly situated health departments.
BIOTERRORISM EDUCATION IN BOSTON
The Boston Public Health Commission (BPHC) has engaged in several initiatives
to educate providers and the general public about bioterrorism. In addition, we have
conducted trainings and disseminated information on workplace mail safety proce-
dures for other City agencies and a number of major businesses.
Train the Trainer for Health Care Providers
As mentioned previously, the Surveillance Task Force has developed a bioter-
rorism lecture. BPHC also operates a train the trainer program for lecturers.
BPHC provides the lecture in a CDROM format and also provides written mate-
rials for dissemination at lectures. BPHC updates the lecture regularly. To date the
lecture has been delivered at Boston hospitals, university health centers, a major
HMO, and at schools of public health and nursing.
Clinical Advisories
The Commissions Communicable Disease Control Program develops regular clin-
ical advisories for health care providers with guidance on the latest national and/
or local incidents, symptoms, diagnosis, treatment, and any other recommendations
from the U.S. Centers for Disease Control and Prevention. These advisories are sent
out to all members of the Surveillance Task Force, community health centers, Con-
ference of Boston Teaching Hospitals, university health centers, hospital-based in-
ternal/primary care providers and school based health services as well as posted on
the BPHC website.
Training Commission Staff
The Commission has identified key clinical staff from all its programs as well as
key non-clinical staff with the capacity to serve as public educators and staff the
hotline in the event of a major mobilization. These staff have received in-depth
training regarding bioterrorism issues and response plans.
General Public
In addition to regular media appearances by BPHC staff, the Commission web
site is regularly updated with the latest news and recommendations, in addition to
fact sheets about bioterrorism in many languages. See www.bphc.org for this infor-
mation. This information can also be accessed through the City of Boston website
at: http://www.cityofboston.com/.
A dedicated phoneline has been established with a recording in Spanish and
English. Staff is available to answer questions in both languages during usual busi-
ness hours. A manager on call is available by pager to answer urgent questions
after hours.
The Commission also partnered with the state health department to develop a
supplement on bioterrorism for a major daily newspaper offering practical informa-
192
tion for readers, and a monthly health education column in community papers pro-
vides similar practical information.
Well, this has been a very informative gathering. I thought I
would start my line of questioning by responding a little bit to
what Senator Stevens had said. I had interrupted him once. I did
not want to interrupt him again. But regarding the point that Sen-
ator Stevens made about building up and spending all this money
against a nonexistent threat, let me put a different face on it.
I remember the farewell speech that another former chairman of
this full committee gave when he left the Senate, Senator Mark
Hatfield. I was sitting on the floor listening to that, and I remem-
ber he was talking about where we ought to be focusing our atten-
tion in terms of governmental spending. I think that is sort of the
gist of what it was.
He said: No longer is the threat that the Russians are coming,
the Russians are coming. He said: The threat is the viruses are
coming, the viruses are coming. I will never forget that. Now, he
was not talking about it in terms of a bioterrorist threat. That was
not even on the horizon. He was talking about it in terms of the
naturally occurring viruses that mutate over time, that evolve and
threaten us periodically, the new pathogens that arise. Maybe we
dealt with one, but over time they mutate, they become stronger,
they develop different strains that we have to attack.
Sometimes, as we know, they can become very virulent, HIV for
example. We still do not know how to attack the HIV virus, but it
has killed millions and millions of people.
So building up against a nonexistent threat. Well, maybe in
terms of the bioterrorist threat, it may be so. But if we build up,
we protect ourselves against the naturally occurring disease
threats that also may come down the pike in the future.
There is an old saying, there is no dark cloud but what has a sil-
ver lining. Perhaps out of what is happening to us in this country
may come a silver lining. Now we recognize the need to bolster our
public health system in this country and around the world.
I just think for too long we have just sort of skimmed by, and
now we recognize in this hour of darkness that we have in our
country right now the need to respond to the possibility of man-
made threats. But out of that comes the possibility that we will
also build up our defenses against the non-man-made threats that
come down the pike in the future.
So I see it a little bit differently, that it is an existing threat. As
long as there are viruses and pathogens in the world, there is that
threat. Regarding food safety, we lost about 5,000 people I think
in New York in the World Trade Center buildings, but last year
there were about 5,000 who people died of food-borne illnesses in
the country. Millions more got deathly sick and lived. So we are
finding that some of these strains in our food are becoming more
virulent than they were in the past, strains of salmonella, botu-
lism, things that we have attacked with antibiotics over time, but
they have become more resistant and they have become harder to
attack.
193
So our public health system needs to be beefed up. Regarding

communications, Dr. LeDuc, I believe it was in your statement that
only 13 States, 13 States, have connections from their central State
public health office to all of the local public health offices. Is that
right?
Dr. LEDUC. That is correct, sir.
Senator HARKIN. That is abysmal. I found out that there are
some States that do not even have 24-hour, 7 day a week response
from their hygienic labs. Some States do, some States do not. I do
not know how many there is like that.
You talked about the Health Alert Network. Senator Byrd said
in his opening statement that there are some of them are not even
hooked up to the Internet. They do not even have a fax machine
to be able to respond. Right, Dr. Barry?
Dr. BARRY. That is absolutely true. There are some small com-
munity health departments that do not have fax machine, Internet
access, that is true.
Senator HARKIN. I will bet you they are mostly in our rural
areas. That is where they mostly are. There may be some in cities
too, but I bet you in rural areas there are even less.
So I make those points again just to say that we are all on the
right track, Senator Byrd. You are on the right track in getting this
money out there to beef up our public health system in America.
Certainly there are different priorities.
Right away, I think the first priority is to ensure that we have
adequate vaccines against smallpox. We are on the way to that,
and I am going to ask a couple of questions about it. But then we
need other kinds of responses for the other type of weapons of mass
destruction that might be introduced by a terrorist.
But then beyond that, I think we have to do other things. By the
way, Dr. LeDuc, I was a little remiss in not thanking you for the
phone call last week. I had a lot of my colleagues asking me all
these questions about smallpox and I did not have the answers, so
I had to get some answers, and I appreciate that.
Dr. LEDUC. It was my pleasure, sir. Thank you.
Senator HARKIN. I listened to Dr. Barry speak about the lack of
coordination and the Health Alert Network. Is there a manual, is
there a blueprint, is there something that a local health depart-
ment could go to and say, we have got something here, open the
book, here is what we do? Is there such a blueprint, is there such
a manual from CDC?
Dr. LEDUC. Yes, sir, there is. It is just in final review stage. That
will be sent out in the next couple of weeks as a draft, with Draft
on the top, so that we can get more active feedback from the local
level. That is, a very comprehensive plan, and is ready to go.
Senator HARKIN. Will that be made available on the CDC
website? How will local health departments get this? You have got
to get it out there in a hurry.
Dr. LEDUC. Well, we will certainly use the Health Alert Network
as part of that distribution process. I can get back with you for the
details of how else we will get it out. I do not have that off the top
of my head, but I will.
Senator HARKIN. That needs to be gotten out there in a hurry,
because as I understand it there really is no blueprint right now.
194
There is not a cookie-cutter type of an approach that you can go

to and say, here is what we do if this happens.
Dr. LEDUC. It is virtually done.
Senator HARKIN. Now, let us get back to smallpox again. It is my
understanding that there are some 400 different strains of small-
pox. Is that true or is someone telling me a story here? Dr. Fauci
or Dr. LeDuc?
Dr. LEDUC. We have over 400 different isolates from individual
patients that are in the CDC collection. That collection was accu-
mulated as the global eradication campaign proceeded. They were
put into two different repositories, one at CDC and one in Russia.
There are about over 400, about 450 isolates.
Senator HARKIN. Will the vaccines that we have on hand, the
15.4 million doses that we have on hand, that was developed
through the old methodology, will that protect against all those
strains?
Dr. LEDUC. Yes, sir. This vaccine was used in the global eradi-
cation campaign and did protect against wild-type smallpox.
Senator HARKIN. That is comforting to know.
Now let me ask the follow-up question. Regarding the vaccines
that you are now developing that are not based upon the old meth-
odology, how confident are you that those will also protect against
all those strains?
Dr. LEDUC. We are working very closely with the Food and Drug
Administration to develop a strategy to show that the vaccine is
not inferior, the new vaccine is not inferior to the old one.
Senator HARKIN. Tell us how you will do that and how long will
it take?
Dr. LEDUC. It is being done now. In fact, there is a number of
pre-clinical tests have already been done, animal experiments, cell
culture experiments, these sorts of things, and at every point we
have shown that the new vaccine is identical to the old vaccine.
Senator HARKIN. But you do have to go through some clinical
trials, do you not?
Dr. LEDUC. The clinical trials that we will look at are primarily
focused on safetywell, making sure that it does not make people
sick, then making sure that it produces the kind of immune reac-
tion that we know is protective.
Senator HARKIN. Now, you are absolutely certain, 100 percent
certain, that the stored vaccines will protect against all of them be-
cause it was used in the worldwide eradication?
Dr. LEDUC. Yes, sir, we are.
Senator HARKIN. Give me your level of confidence in the new vac-
cines and the ones that are developed in the petri dishes?
Dr. LEDUC. I am very, very confident that this will be equally as
effective. There is a very small difference in the new vaccine versus
the old one. It is only in the method of manufacture. We no longer
make it in calves; we make it in cell culture, which is the way we
make virtually all of our other viral vaccines.
Senator HARKIN. As confident? Are you as confident as the old
ones?
Dr. LEDUC. You said 100 percent. I am 99.9 percent.
Senator HARKIN. That is pretty good.
195
Dr. Fauci, in your prepared statement you mentioned there is an

anti-viral, I cannot even pronounce it, called Cidofovir.
Dr. FAUCI. Cidofovir.
Senator HARKIN. What?
Dr. FAUCI. Cidofovir.
Senator HARKIN. Cidofovir has been found effective against
smallpox. Can you tell us more about this, and will it work?
Dr. FAUCI. Yes. As I mentioned in my oral statement also, Sen-
ator, cidofovir was originally developed as an anti-viral against
cytomegalovirus for the purpose of treating that complication in
HIV-infected individuals. In studies that have been performed in
an animal model in which animals were challenged with pox vi-
ruses with strong resemblances to smallpox, a variety of viruses, it
proved to be highly effective in treating in that animal model, pri-
mate monkey model.
Based on that, an investigational new drug application has been
taken out to determine, as a secondary backup, if cidofovir could
be used in our vaccination programs when people get a reaction
against the vaccine. The first thing you would do is to give vaccinia
immune globulin. We are going to use cidofovir as a backup. We
are also pursuing developing or getting an IND for its use in the
treatment of smallpox.
The animal model data are very impressive, but, as is always the
case with an animal model, there is a leap from the animal model
to the humans. So you cannot say, as Dr. LeDuc mentioned with
regard to his confidence in the smallpox vaccine, you cannot have
that same confidence in an anti-viral since it has not been tested
in humans with smallpox.
But if you look at the data that emanated from the animal stud-
ies with similar pox viruses, it is quite impressive, the data. That
is the reason why investigators are not only pursuing cidofovir
itself, but they are doing a large screening on drugs that are of the
class of cidofovir to see if you could come up with even a better one.
Senator HARKIN. That is being aggressively pursued?
Dr. FAUCI. Quite aggressively, yes.
Senator HARKIN. Is that under your guidance?
Dr. FAUCI. It is a combination of ourselves and the Department
of Defense USAMRIID.
Dr. LEDUC. And the CDC.
Dr. FAUCI. I am sorry, I am sorry. When I say us, we do every-
thing together. I take it for granted. It is the CDC, NIH, and
USAMRIID.
Dr. LEDUC. Let me just add to that, sir, for clarity. We are actu-
ally, and have been for the past 2 years, working with live Variola
virus, the virus that causes smallpox, at CDC in our maximum con-
tainment laboratory. Senator Specter saw the space suit labora-
tories. We are actually doing the testing of the drugs that Dr. Fauci
mentions against the virus itself.
Senator SPECTER. I saw those when I made the trip down there.
Dr. LEDUC. Yes, sir, you did.
Senator SPECTER. Are you improving those conditions? We have
got $170 million last year, $250 million this year, long before this
was a focus of attention.
196
Dr. LEDUC. We are indeed. Thank you very much for that. We
thank you for that.
Senator SPECTER. All you had to do was ask.
Dr. LEDUC. Thank you.
Senator HARKIN. I just might say to Senator Byrd, both of us
have been down there and looked at CDC. We paid a lot of atten-
tion to NIH, rightfully so. We doubled their funding in about 5
years, Senator Specter and I.
Senator SPECTER. May I interject at this point, Mr. Chairman,
just for a comment or two?
Senator HARKIN. Let me just finish my statement. I was just
going to say that we both visited CDC. The CDC is our front-line
defense in America against illnesses and public health. They are
spread out all over the place. Some of their labs date back to World
War II buildings, really, literally. I could not believe it when I saw
how out of date they are.
In fact, I learned when I was down there, they made a movie,
one of these scary movies.
Dr. LEDUC. Outbreak, I think, Outbreak.
Senator HARKIN. Outbreak. I saw it. It is one of those movies
about an outbreak of disease. They wanted to film a movie, they
wanted to film at CDC to show the buildings and how they do all
of this. I was told that the buildings were so decrepit and old that
the movie producers decided to build their own set because the peo-
ple would not believe it.
Is that true?
Dr. LEDUC. Yes, sir, that is true. But we are getting better and
we appreciate your help.
Senator HARKIN. I am just saying that is why we need to rebuild
that. Can we use the movie set? No?
Senator SPECTER. I wanted to make a comment about our level
of preparedness and it ties in to what happened with the Center
for Disease Control. There had never been a request by the Depart-
ment of Health and Human Services to improve the physical plant
there. Senator Harkin and I heard about it from the people in At-
lanta and we took the initiative to go down there. I spent a Sunday
taking a look at it and had a hard time. I had heard that it was
awful, but what I had heard was wrong. It was worse.
On the initiative of this subcommittee, last year we put in $170
million. That is hard to find in our budget, but we did it because
of the importance. This year we put $250 million in before Sep-
tember 11 occurred. But to be candid or really blunt, I do not like
what I am hearing today. Senator Harkin says we are on the right
track and I think we are, but we are a long way from the station,
just a long way from the station.
Now, when it came to the National Institutes of Health this sub-
committee took the lead 6 years ago to ask a lot of hard questions.
We saw what NIH could do on Parkinsons and Alzheimers and
heart disease and cancer, and every year we brought in the 25 di-
rectors of NIHyou were always here, Dr. Fauciand we said, if
we give you a billion dollars more next year, what can you do with
it? Then we put a billion in 5 years ago.
We had to take it out of the budget that we had because the
Budget Committee would not give us more. $2 billion the year after
197
and $2.3 billion. Every year we brought in the experts and said,
what did you do with the extra money last year and if you get more
money what will you do with it next year.
But we did not have the foresight to ask you about diseases.
Candidly, Dr. LeDuc, I think the Center for Disease Control should
have come to this subcommittee and should have said, smallpox is
a problem, we have only got 15 million vaccines, maybe we can di-
lute them one to five.
Now, I asked Dr. Koplan, the head of CDC, on October 23 to give
us a list of all the possibilities of bioterrorism and what it would
cost. But I think the American people have the standing to be very
dissatisfied with what their government has done. The first respon-
sibility of government is security of the people, and we have so
hamstrung the CIA when we had people who were informants that
were not Boy Scouts that we precluded the CIA from having those
informants to deal with intelligence. So we are vastly unprepared
on intelligence.
Now you could itemize the dangers of smallpox which we are
talking about today, and as we took the initiative on NIH because
we understood that, and we talked about bioterrorism, we put a lot
of money into it, but not nearly enough. So I think what we really
have to do is face up to the failures and find out how fast it can
be done.
I think the American people have a right to be very dissatisfied
with what we have done for them.
Dr. LEDUC. Sir, I will relay that message.
Senator HARKIN. Dr. Friedman, did you have something you
want to add?
Dr. FRIEDMAN. Not directly to Senator Specters point, but if you
will allow me to go back to the point you were making, Mr. Chair-
man, if you would allow me to make just a brief comment on the
military metaphor that you talked about. Senator Specter was talk-
ing about it, Senator Byrd as well. There are differences between
wars. You make a mistake if you compare one with the other. But
if you think that we were not well prepared when World War II
started, the country had to do a lot of work and there were a lot
of mistakes made in terms of how quickly we came up to speed, it
is not inappropriate to make that comparison.
From my point of view, if you think that our industrial might
really helped us to win World War II, and I think that most people
would say that it did, what I would suggest to you this morning
is that for this war the pharmaceutical industry is the most perti-
nent power for helping us to defend our freedom. We are not going
to do it alone, but we are going to provide the weapons for the pub-
lic health infrastructure that everyone is talking about here today
and which absolutely needs to be improved.
We can provide those weapons and we want to be the industrial
might that helps win this war.
Senator HARKIN. Dr. Friedman, as a matter of fact I had a ques-
tion here. Dr. Friedman, what do we need to do to move this for-
ward more rapidly? I made a note here about joint government-in-
dustry effort like World War II.
Dr. FRIEDMAN. Yes, sir.
198
Senator HARKIN. Just like what we did in World War II. The gov-
ernment joined with the auto industry, it joined with the aircraft
industry, it joined with all kinds of industries in a joint effort. I
think we can use that.
You are right, not every war is the same. But it seems to me that
you are right, the pharmaceutical industry in this country is the
best in the world. We take a back seat to no one. Our pharma-
ceutical industry, our research scientists, our ability to develop and
bring to market new drugs and new remedies is unparalleled any-
where in the world, anywhere in history, any time in history.
Dr. FRIEDMAN. That is right, sir.
Senator HARKIN. It seems to me this is the group we have got
to go to now to ramp up and to provide the kind of protections our
people need. I hope that with this committee and with other com-
mittees of the Congress that we could have that kind of joint gov-
ernment-industry cooperation. I see no reason why we cannot.
Dr. FRIEDMAN. We appreciate that, sir. Thank you.
Senator HARKIN. Senator Byrd, I know I wanted to recognize
you. You said you wanted to say something?
Senator BYRD. Mr. Chairman, I found so interesting your ques-
tions and the questions of others on the panel. I feel that I have
gained a great deal of knowledge here today and I think that we
four, you and Senator Specter and Senator Stevens and I, are in
a position here on this Appropriations Committee to do something
about this war and I believe we will.
Now, my mother died in the great influenza epidemic in 1918,
and people contracted the disease one day and were buried the
next or perhaps died the same afternoon. That epidemic killed 20
million people around the world, 12 million in India and probably
750,000 in this country.
My question would be this. I hardly know how to phrase it. In
the context of todays circumstances, todays treatments, todays
abilities to recognize anthrax, smallpox, and influenza, and all of
the various aspects, if an enemy were to seek to somehow spread
any one of these three pathogens, how would you rate the one most
dangerous, the one most dangerous to us as a Nation, the one per-
haps most easily spread by an enemy?
Which would be worseI will narrow it downbetween anthrax
and smallpox? If you were the enemy, which would you think could
cause the greatest damage to our countrythat is No. 1.
No. 2, what is the lifespan of the smallpox virus? If it were re-
leased into the air over in McLean where I live and if the wind is
blowing this way, how long, how far would that virus be potent?
What is its lifespan?
That leads me to think that if an enemy sought to diffuse this
smallpox virus in the air somehow, if he were of a nation across
the Atlantic, would he need to be cautious lest this wind drive this
virus across the sea to his own country?
Dr. LEDUC. I do not have accurate information on the stability
of smallpox virus. I know it is a rather stable virus, especially in
the crust after a person has been infected. As an airborne particle,
I would assume, like many viruses, that it would be degraded over
time by UV, sunlight, radiation. I do not think it would be crossing
199
any oceans. It would be a matter of hours, I suspect, before it is

inactivated. But that is strictly my personal guess.
Senator BYRD. All right. As between this and that, as I said ear-
lier, which would you
Dr. LEDUC. Well, I certainly do not want to place public chal-
lenges on which is better.
Senator BYRD. No, not which is better, but
Dr. LEDUC. Which is worse, exactly. Actually, we know that
there will be influenza outbreaks and I think that this is an area
in which we need to remain vigilant. Regarding the comparison be-
tween smallpox and anthrax, anthrax is no longer a theoretical
risk. I think we need to be very prudent in our approach to this,
and I think likewise the steps that we are proposing to take in pre-
paring the Nation for smallpox are equally prudent and essential.
Dr. FAUCI. Senator, as a fundamental principle a microbe that
could be transmitted from one person to the other is inherently
more dangerous than a microbe that cannot, that does not have
that characteristic of transmissabiltiy. So smallpox, being able to
be easily transmitted, as well as an aberrant form of influenza like
we experienced in 1918, is inherently more dangerous than an
agent, regardless of how virulent it is, that can only attack the per-
son exposed to the agent.
Senator BYRD. Mr. Chairman, this is the first line of defense.
Senator HARKIN. You are right, this is it, and we will do our ut-
most to meet our obligations to give you all the tools you need to
work with industry and to work with our local public health de-
partments, to try to get them up to speed, trained, equipped, and
working closely with the Center for Disease Control.
We have an opportunity now. We have an opportunity to build
the kind of public health system in the United States that we
should have done 20, 30 years ago. I believe by doing so we will
not only protect our people against the man-made threats, but
against the naturally occurring threats that may be coming down
the pike also. So out of the dark cloud that is what I see as our
silver lining. That is what we will do.
Senator SPECTER. I have another question or two, Mr. Chairman.
Dr. Fauci, in 1994 the budget for the National Institute for Infec-
tious Diseases was $1.063 billion and the current is $2.063 billion.
With the increases which this subcommittee has proposed, next
year it is going to be $2.375 billion. My question to you is, when
we have doubled it and now projecting more than doubling it, has
your department in NIH on infectious diseases directed a signifi-
cant amount of that increase to bioterrorism?
Dr. FAUCI. The increase, yes, Senator. The relative increase of
bioterrorism resources compared to the relative increase of other
infections, it is on a steep
Senator SPECTER. Could you give us a ballpark figure?
Dr. FAUCI. Yes, I can do that. If you look atI can just give you
some numbers on bioterrorism from our Institute. In year fiscal
2000excuse mefiscal 1999, it was $23.8 million. In the year
2000, $32.6 million. Then it jumps up in 2002 to Presidents budget
of $81.5 million.
Senator SPECTER. Well, I suggest to you that $23.8 million and
$32 million are a very, very small part of $2 billion.
200
Dr. FAUCI. I agree with you.

Senator SPECTER. I think you need to do better.
Dr. FAUCI. We will. I agree with you.
Senator BYRD. Would the Senator yield?
Of the $81.5 million in the budget, how much did you ask for?
You have standing between you and the budget the Office of the
OMB.
Dr. FAUCI. Right.
Senator BYRD. And they generally cut what you request. How
much did you request?
Dr. FAUCI. The initial request was about that ballpark, Senator.
But a lot of things happened between the original request and
where we are standing right now vis a vis the assessment of that.
Senator SPECTER. Senator Byrd, this subcommittee has seen to
it that OMB does not stand between NIH and funding.
Senator BYRD. Hallelujia.
Senator SPECTER. Last year the President asked for a billion dol-
lars. Senator Harkin and I took the lead and put in $2.8 billion.
We have made a determination on priorities as to how important
NIH was.
But I am a little disappointed, Dr. Fauci, that you only used $32
million of that money for bioterrorism.
Let me say this to you, Dr. LeDuc. I already asked Dr. Koplan,
the head of the Center of Disease Control on October 23rd for a list
of agency problems in bioterrorism and what it would cost. Go back
and give us a figure as to what it would take, what would it take
on smallpox to have the vaccine for 280 million Americans. Then
go down the list and tell us what it would take, and let us make
the decision as to whether we are going to fund it or not. That is
a decision for Congress. That is Congress job. Your job is to tell
us what it takes.
You listened to the Boston Public Health Service and Dr. Barry
who is struggling under circumstances which are disgracefulone
infectious disease doctor. So if there is going to be follow-up here,
let it rest with the Congress. You tell us what it takes and I think
we will provide the resources.
Dr. LEDUC. Well, I will certainly relay that message.
Senator HARKIN. With that, we thank you all very much, and
thank Senator Byrd for gracing us with his presence and for his
interest and leadership in this area. We thank you so much. Thank
you all for your leadership in your respective areas. We look for-
ward to working with you.
SUBCOMMITTEE RECESS
ing.
[Whereupon, at 11:01 a.m., Friday, November 2, the sub-
Chair.]
FUNDING FOR BIOTERRORISM
PREPAREDNESS
THURSDAY, NOVEMBER 29, 2001
U.S. SENATE,
SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:08 a.m. in room
SD192, Dirksen Senate Office Building, Hon. Tom Harkin [chair-
man] presiding.
Present: Senators Harkin [presiding], Kohl, Landrieu, Specter,
and Stevens.
Senator HARKIN. The Subcommittee on Labor, Health, Human

Services, and Education will come to order. Today marks the sub-
committees fourth hearing this year on bioterrorism. This morning
we will focus on the resources required to improve our public
health infrastructure and protect Americans from a possible bio-
logical weapons attack.
In recent years this subcommittee made significant new invest-
ments in our public health system. We have made progress, but we
know it is not enough. Recent events and expert testimony before
this subcommittee have made one thing perfectly clear: Our Na-
tions public health system is not adequately prepared to either
prevent or respond to a biological weapons attack. To properly pre-
pare, we must begin to think of our Nations public health system
as the front lines in our battle against terrorism.
Right now we do not have enough vaccines to protect every
American. We will be discussing that this morning. But public
health officials are without the tools and training they need to de-
tect an outbreak and rapidly respond. Prudence demands action
and that is why Senator Specter, Senator Byrd, and I have crafted
a $4 billion bioterrorism initiative. We plan to press ahead with
this initiative and we should not end this session without acting to
protect the American people.
Last week Director of Homeland Security Tom Ridge stated that
the administration intends to request substantial new funding for
bioterrorism as part of the 2003 budget request. With all due re-
spect to Mr. Ridge and the administration, these funds would come
much too late. Safeguarding this Nation against public health
threats demands immediate action. If a nation declared war on the
United States, we would not wait until next fiscal year to prepare.
(201)
202
We would act and get prepared now, and that is what we have to
do in the public health sector.
That is why Senator Specter and I are finalizing legislation that
we will introduce later today hopefully, much of it based on this
mornings testimony. Our plan would be to boost our Nations de-
fenses against bioterrorism. Among other things, we would put the
bulk of the funding, $1.3 billion, into improving our public health
departments, shoring up local lab capacity, and expanding the
health alert network. Our proposal would also allocate $200 million
for research at NIH on new vaccines.
Earlier this month our subcommittee heard testimony from Dr.
Fauci, who is with us this morning, about the promising future of
antivirals against smallpox, and so we want to see again how much
more we need to invest in that area.
Our plan also provides substantially more money to boost the
work of the Centers for Disease Control and Prevention. We need
to upgrade their overburdened lab capacity and their disease sur-
veillance systems.
We need to do more this year to make sure that Americans are
fully protected against anthrax, smallpox, other types of pathogens
that might be used in a bioterrorist attack. We have a distin-
guished panel of witnesses before us today. I really want to thank
them for joining us. I would, before I yield to Senator Specter,
again just pay my respects and my accolades to you, Dr. Koplan
especially, and for the Centers for Disease Control and Prevention
for all of the great work that you have done out there in respond-
ing to the anthrax attacks that have been bedeviling us around the
country. I know you have got your investigators hot on the trail.
I know they are working hard.
I think Americans everywhere ought to understand that these
soldiers working for the Centers for Disease Control are putting
their lives at risk every day, in much the same way as our soldiers
in Afghanistan are putting their lives at risk. These are the people
that go out, that have to expose themselves openly to anthrax, as
the case may be right now. They are doing the lab work and they
are exposing themselves to the possibility that they too might get
infected.
So I just wanted to point that out that they have been doing a
great job under very trying circumstances. I hope, Dr. Koplan, you
will pass on to all of the people that work in the Centers for Dis-
ease Control our high esteem and our genuine thanks and appre-
ciation for all of the hard work that they are doing and the risks
that they are taking on themselves for tracking down this anthrax
scare.
Dr. KOPLAN. Thank you. That means a lot to us.
Senator HARKIN. Senator Specter.

There is no more important subject for America today than the
subject matter of this hearing. The American people face the poten-
tial of an imminent threat of bioterrorism. We have had in the past
several weeks two high alerts from the administration and the im-
ports of those alerts is the potential for a bioterrorist attack. It is
203
indispensable that we address the subject now before the Congress

adjourns for whatever funding is necessary to meet this danger.
An administration report published in last Fridays New York
Times talked about including this funding in next years budget.
That appears to mean for the budget beginning October 1st, 2002,
and we know the reality of that is later than the end of the fiscal
year and into 2003 before the funding could be started. That, sim-
ply stated, is too late.
This subcommittee had an earlier hearing where Dr. Koplan tes-
tified when we were ousted from this building because of bioter-
rorism, because of anthrax, and we asked at that time to have a
comprehensive list of all the threats and what it would take in dol-
lars and cents to meet them. Then we had a hearing in this room
a couple of weeks ago where Dr. Fauci and others testified about
what needed to be done with respect to the focus on smallpox. At
that time the debate centered on the issue that vaccinations were
not really necessary, that there would be time to inoculate after ex-
posure.
My rejoinder was that the government has the responsibility to
have the vaccines available and then the citizens can make a deci-
sion as to whether they want to undertake the risks, which were
identified as one to six out of a million. Dr. Fauci and I had a little
discussion about our grandchildren and I said I wanted my grand-
children inoculated. It is not my decision, by the way. It is my son
and daughter-in-laws decision. They are the people to determine
what their children will have. I think Dr. Fauci came around to my
way of thinking and he wanted his grandchildren immunized, vac-
cinated, too.
The point is that it is governments responsibility to have it
available. I made the point that this subcommittee, with Senator
Harkins leadership and my joinder, has provided enormous fund-
ing for NIH. We saw the needs there. NIH did not come forward
and ask us to double the money, because NIH is controlled by
HHS, and HHS is controlled by OMB, and by the time you finish
the alphabet soup Congress cannot find out what is going on, un-
less we use back channels to find out.
But we saw the potential for NIH ourselves and we took a budget
of $12 billion and with this years appropriation it will be $11 bil-
lion more. That is a great tribute to America for what NIH has
been doing on Parkinsons and Alzheimers and heart attacks and
cancer and a whole litany of ailments.
When we heard that the CDC needed additional capital improve-
mentsand we did not hear it from the Secretary of HHSSen-
ator Harkin and I made trips down there on our own to take a look
at the facilities. Before we had this emergency of September 11th,
more than a year ago we added $170 million to their capital pro-
gram, because this subcommittee is determined to see to it that the
medical needs of America are taken care of.
This year we have added $255 million on our way to a billion dol-
lar program. I think this is a lesson for government generally. You
professionals need to tell us what you need, and if we do not fund
it then it is our responsibility.
204
So I am glad that we are going to get the figures today and we

are talking about ways to include it in the budget to make sure
that it does get done.
We have been joined by our distinguished ranking member of the
full committee, Senator Stevens.
Senator STEVENS. Senator Kohl.
Senator HARKIN. Senator Kohl, did you want to make an opening
statement?
Senator KOHL. No.
Senator HARKIN. Senator Kohl is deferring, Senator Stevens.
OPENING STATEMENT OF SENATOR TED STEVENS
Senator STEVENS. I intend to stay, Senator, so I would be happy

tothank you very much.
It is nice to see you again, Dr. Fauci and Dr. Koplan. I am
pleased to have a chance to be with you today for a little while.
I thank the chairman and the ranking member for holding this
hearing.
Yesterday at another subcommittee I had an exchange with re-
gard to the safety of our business, our buildings here, and the mail.
We were told it is the responsibility of CDC to set the standards
for safety and the standards for the ultimate decision that our
buildings are safe for our staff and the public. I am going to have
some questions about that later if I may, but for now I would say
this, that I do think that we have got a real problem here and the
problem is that, at least as far as I am concerned, there are still
some areas of great misunderstanding about anthrax.
The front page of the Post today talked about how they had to
use a paraffin sheet to capture the anthrax because it is so finely
refined into such small units. We are having to face our staff to tell
them we are going back into that building. I do not know if you
know about it. I asked some questions, for instance, whether the
plants were still there. Friends of mine told me all the plants
should have been destroyed immediately. But in any event, they
said that is where the anthrax spores go around the ranch, into
dirt and into manure; they do not go to books and tables, they go
into the ground.
Apparently there is a difference of opinion here. We have some
real problems ahead of us here now. Dr. Fauci, one of the greatest
ones is that in the years that we have doubled NIH, and this is
the last year, we have decided not to earmark. Yet now that appar-
ently money should be plentiful at NIH, some of the priorities that
the people are screaming at us to get onto the list of these research
agencies are being ignored.
So I want to tell the subcommittee, as far as I am concerned this
is the last year we do not earmark unless we see some action deal-
ing with some of the issues the public is clamoring for details on.
Just for instance, I asked the question, do we know anything about
the anthrax spores? What do they do? What is their range? How
far can they travel without some type of assistance, either by car-
rier or by wind, etcetera? We do not know, apparently.
205
I asked questions about the files and the books in our offices and
I was told, no, they did not open those. They did not open the files
and they did not open the books, because they do not believe the
spores would go there. Well, you try to tell that to a bunch of young
college graduates. Yesterday I tried. It was not acceptable.
I think we have to have some answers and we have to have them
pretty quick. But we have not had that kind of answer. I would as-
sume someone had tried to determine the characteristics of this an-
thrax that was headed toward the Senate and the House, but par-
ticularly the Senate.
So I am going to have some questions about that. I hope that
that is all right with the committee, when we get to that time.
But I do welcome you. Again, we have not spent much time to-
gether, Dr. Koplan, but I had some interesting education with Dr.
Fauci and I hope to get more today.
We will turn to our first panel: Dr. Jeffrey Koplan, Director of
the Centers for Disease Control and Prevention. After him we will
then turn without interruption and without questions to Dr. Fauci,
who is the Director of the National Institute of Allergy and Infec-
tious Diseases at NIH. So welcome. Your statements will be made
a part of the record in their entirety. Dr. Koplan, we will turn to
you first.
STATEMENT OF JEFFREY P. KOPLAN, M.D., M.P.H., DIRECTOR, CEN-
TERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Dr. KOPLAN. Good morning and thank you, Mr. Chairman, Sen-
ator Specter, Senator Kohl, Senator Stevens. I am pleased to ap-
pear before you today on behalf of the Centers for Disease Control
and Prevention, the CDC, and thank you for the invitation to dis-
cuss CDCs public health response to the threat of bioterrorism.
The terrorist events on and since September 11th have been de-
fining moments for all of us and they have greatly sharpened the
Nations focus on public health. But even before the September
11th attack on the United States, CDC with the support of this
subcommittee was making substantial progress to define, develop,
and implement a nationwide public health response network to in-
crease public health capacity at local, State and Federal level.
Since September 11th we have dramatically increased our ef-
forts, resulting in a heightened level of preparedness which we are
committed to increase even further based on lessons learned in re-
cent months.
CDC has used funds provided by the Congress to begin the proc-
ess of improving the expertise, facilities, and procedures at State
and local health departments and then within CDC itself related
to bioterrorism. We have established a bioterrorism preparedness
and response program to direct and coordinate our efforts. We have
over 100 full-time professionals comprising expertise in epidemi-
ology, laboratory science, surveillance. Over the last 3 years we
have awarded over $130 million in cooperative agreements to 50
States, a territory, and 4 major metropolitan health departments to
support preparedness, planning and readiness, epidemiology and
surveillance, laboratory capacity, and improved communications.
206
Since September 11th, we have sent over 500 CDC staff to the
field. For example, at the height of the anthrax response here in
the Washington, D.C., area, we had 85 staff present. Currently in
Connecticut in the investigation we have over 25 staff present
working with the Connecticut State Health Department. These ex-
perts include epidemiologists, industrial hygienists involved in en-
vironmental sampling, laboratorians, communications specialists,
logisticians, management staff.
CDC has also been working with many of the States where there
have not been documented anthrax cases because there have been
threats and hoaxes and hundreds of thousands of laboratory speci-
mens sent to these States, putting a tremendous burden on every
State in the country. In some instances we have augmented their
staff with staff of our own to assist them in getting through the
work load that they had.
We have launched an effort to improve health laboratories across
the country in a network, a laboratory response network, improving
our capability of detecting bioterrorist agents quickly and accu-
rately, and we have done that in partnership with a number of
other groups and laboratories.
We have tried to improve communications systems which are an-
tiquated and in which, for example, less than half of the health de-
partments in this country have direct, secure Internet linkage in
a national communications system for public health.
We have worked to get pharmaceutical materials available to
places in need and we have in place large amounts of materials
that include antibiotics, antidotes, vaccines, materials for blood loss
and trauma, available to any site in the country within 12 hours
of a request for deployment. As an example, in New York the mate-
rials were provided within 7 hours of the request and being distrib-
uted for use.
A critical issue is preparedness of State and local health depart-
ments in this effort. They need to have plans in place to deal with
terrorism. Those plans need to include distribution of supplies,
such as pharmaceuticals, vaccines, antibiotics. Currently CDC
funds only nine States and two cities to do such planning.
Security is a major issue, for facilities in particular, and at CDC
we pay particular attention and effort to this, but have more to do
to increase the quality and status of our security at several sites.
Our challenges for the future. While we have accomplished a
great deal in the past 10 weeks, several challenges remain. One,
it is critical that we bolster the infrastructure of State and local
health departments in the areas such as early detection, laboratory
analysis, crisis communications, and epidemiologic capability.
In addition, we need to forge closer working relationships be-
tween clinical medicine and public health, between hospitals in our
communities, local health departments, law enforcement, other
first responders.
Another important opportunity is to strengthen our relationship
with other Federal agencies. While institutions such as the Na-
tional Institutes of Health and the CDC and the FDA work closely
together many, many times a day, we need to broaden that to in-
clude the law enforcement community. As we have seen in recent
events, a close working relationship can be very helpful in dealing
207
with an event such as bioterrorism, which includes a public health

investigation component and a criminal investigation component.
To facilitate that, we have assigned a senior staff member from
CDC to work at the FBI to improve and assure an optimal inter-
change between the two agencies.
Finally, we need to redouble our efforts to enhance our own ca-
pacity at CDC to respond to future threats. Since October 4th we
have tested over 5,500 laboratory specimens. Our labs are working
24 hours a day. Scientists sleep in their office to avoid losing time.
We need to expand that scientific capacity in the areas of epidemi-
ology, surveillance, and laboratory, as well as accelerating our
plans to improve our physical facilities and enhance security at all
our locations.
In conclusion, the strength of our Nation to deal with bioter-
rorism is only as strong as our weakest links. That means every
local health department, every State health department, and the
Federal capacity have got to all be optimal and they have to be op-
timal in a variety of different capacities: laboratory, ability to in-
vestigate quickly and accurately, communicationthe range of
what modern public health is about.
PREPARED STATEMENT
When that playing field is level, when there are no weak spots,
then we will be truly capable of dealing with a wide range of
threats as they come to us. But a strong and flexible public health
infrastructure is our best defense.
PREPARED STATEMENT OF JEFFREY P. KOPLAN, M.D.,
Good morning, Mr. Chairman and Members of the Subcommittee. I am pleased
to appear before you on behalf of the Centers for Disease Control and Prevention
(CDC). Thank you for the invitation to discuss CDCs public health response to the
threat of bioterrorism.
The terrorist events on and since September 11th have been defining moments
for all of us-and they have greatly sharpened the Nations focus on public health.
Even before the September 11th attack on the United States, CDC was making sub-
stantial progress to define, develop, and implement a nationwide public health re-
sponse network to increase the capacity of public health officials at all levels-local,
State, and Federal-to prepare for and respond to deliberate attacks on the health
of our citizens. Since September 11th we have dramatically increased our efforts,
resulting in a heightened level of preparedness, which we are committed to increase
even further based on lessons learned in recent months.
CDCs top priority is to protect the Nations health. To do this, CDC focuses on
building a solid public health infrastructureat CDC, as well as at the State and
local level to protect the health of all citizens. As recent events have shown so dra-
matically, we must be constantly vigilant to protect our nations health and security.
The war on terrorism is being fought on many fronts, and we must ensure a strong,
robust public health system to be on guard at all times to prevent and respond to
multiple and simultaneous terrorist acts. The arsenal of terrorism may include bio-
logical, chemical, and radiological agents as well as conventional and non-conven-
tional weapons, as the attack on the World Trade Center so vividly attests.
BIOTERRORISM PREPAREDNESS
CDC has used funds provided by Congress to begin the process of improving the
expertise, facilities and procedures of State and local health departments and within
CDC itself related to bioterrorism. CDC has established a Bioterrorism Prepared-
ness and Response Program to direct and coordinate our activities. CDC has a dedi-
cated anti-bioterrorism staff of more than 100 full-time professionals comprising ex-
pertise in epidemiology, surveillance, and laboratory diagnostics.
208
Over the last three years, we have awarded more than $130 million in cooperative
agreements to 50 States, one territory and four major metropolitan health depart-
ments to support,
(1) Preparedness planning and readiness assessment;
(2) Epidemiology and surveillance
(3) Laboratory capacity for biological or chemical agents; and
(4) The Health Alert Network (a nationwide, integrated, electronic communica-
tions system).
Since September 11, we have sent almost 500 CDC staff to the field. For Example,
at the height of the anthrax response in the Nations Capital, there were 85 staff
in Washington, DC alone. These experts included epidemiologists, industrial hygien-
ists involved in environmental sampling and clean up, laboratorians, communica-
tions specialist to assist with media relations, and logistics and management staff.
CDC not only investigated cases that proved to be anthrax in four States and the
District of Columbia, but also investigated suspicious cases in six other States.
These cases proved not to be anthrax, but required CDC assistance to go through
the process of ruling them out. CDC experts were needed to augment the staff of
State and local health departments, who would have been severely overtaxed with-
out our help. The Administration has requested $20 million through the Emergency
Response Fund to create additional specialized Federal teams and place additional
Epidemic Intelligence Service (EIS) officers in more States.
CDC has launched an effort to improve health laboratories that likely would be
called upon to identify a biological or chemical attack. The Laboratory Response
Network (LRN), a partnership among the Association of Public Health Laboratories
(APHL), CDC, FBI, State Public Health Laboratories, DOD and the Nations clinical
laboratories, will help ensure that the highest level of containment and expertise
in the identification of rare and lethal biological agents is available in an emergency
event. The LRN also includes the Rapid Response and Advanced Technology Labora-
tory at CDC, which has the responsibility of providing rapid and accurate triage and
subsequent analysis of biological agents suspected of being terrorist weapons. The
Administration has requested $35 million under the Emergency Response Fund to
improve State and local health departments laboratory capacity and improve CDCs
internal laboratory capacity.
The CDC is also working to provide coordinated communications in the public
health system, between Federal agencies and between public health officials and the
public itself. To this end, CDC has the Epidemic Information Exchange (EPIX).
The EPIX is a secure, Web-based communications network that will strengthen
bioterrorism preparedness efforts by facilitating the sharing of preliminary informa-
tion about disease outbreaks and other health events among officials across jurisdic-
tions and provide experience in the use of a secure communication system.
CDC has invested $90 million in the Health Alert Network (HAN), a nationwide
system that will distribute health advisories, prevention guidelines, distance learn-
ing, national disease surveillance information, laboratory findings and other infor-
mation relevant to State and local readiness for handling disease outbreaks. HAN
provides high-speed Internet connections for local health officials; rapid communica-
tions with first responder agencies and others; transmission of surveillance, labora-
tory and other sensitive data; and on-line, Internet- and satellite-based distance
learning. With the addition of several recent awards, CDC has provided HAN fund-
ing and technical assistance to 50 State health agencies, Guam, the District of Co-
lumbia, three metropolitan health departments and three exemplar Centers for Pub-
lic Health Preparedness. The Administration has requested an additional $40 mil-
lion through the Emergency Response Fund to improve and expand these systems.
CDC also manages the National Pharmaceutical Stockpile (NPS), which provides
us with the ability to rapidly respond to a domestic biological or chemical terrorist
event with antibiotics, antidotes, vaccines and medical materiel to help save lives
and prevent further spread of disease resulting from the terrorist threat agent. The
NPS Program provides an initial, broad-based response within 12 hours of the Fed-
eral authorization to deploy, followed by a prompt and more targeted response as
dictated by the specific nature of the biological or chemical agent that is used. The
first emergency deployment of the NPS occurred in response to the tragedy in New
York City.
We saw just how critical local planning iseach State and community needs to
plan for terrorism. The planning process builds essential relationships among public
health, emergency management, and health care providers. And this coordination,
especially with law enforcement must be strongat the Federal, State, and local
levelas the anthrax investigations have highlighted. Currently, CDC funds only
nine States and two cities to do this planning. Under the Administrations Emer-
209
gency Response Fund request, an additional $10 million will allow all States and
territories to receive funding for planning and preparedness activities.
In light of the recent terrorist attacks, it is important for CDC to improve security
in its facilities. CDC received an additional $3 million in the initial Administration
release of Emergency Response Funds, and the Administrations Emergency Re-
sponse Fund request also includes an additional $30 million to secure CDC facilities,
particularly where special pathogens may be stored. Also, as mentioned earlier,
there is an additional $20 million to improve and upgrade CDCs internal laboratory
capacity.
CHALLENGES FOR THE FUTURE
Although we have accomplished a great deal in the past 10 weeks, we have sev-
eral remaining challenges .
First, it is critical that we bolster infrastructure in State and local health depart-
ments. As evidenced by our experiences following the September 11th and anthrax
incidents, public health departments are at the frontlines of emergency response.
State and local health departments need expanded capacities and resources for key
preparedness and response functions such as early detection, laboratory analysis,
and crisis communications.
In addition, we must continue to forge relationships between clinical care and
public health. It was through the efforts of clinicians that we were able to identify
the cases of anthrax. These physicians reported the cases to their local public health
authorities and obtained laboratory specimens for analysis at State laboratories and
CDC. The closer the relationship between clinical medicine and public health the
faster we are able to identify potential bioterrorist threats and other outbreaks,
identify the cause of the illness, and provide early treatment to save lives.
Another important opportunity is to strengthen our relationships with other Fed-
eral agencies, and State and local agencies outside the field of public health. Since
September 11th, we have created stronger partnerships with a wide range of agen-
cies, particularly the law enforcement community. For example, in response to the
recent events, CDC assigned an individual to work at the FBI to assure optimal in-
formation exchange between the two agencies. As we prepare for any future threats,
we need to maintain and enhance our ties with a much larger range of agencies.
Finally, we must redouble our efforts to enhance our own capacity at CDC to re-
spond to future threats. For example CDC has tested over 5400 human and environ-
mental samples since October 4, our labs have worked around the clock, with sci-
entist sleeping in their offices to avoid losing time. We need to expand our scientific
capacity in the areas of epidemiology, surveillance, and laboratory, as well as accel-
erating our plans to improve our physical facilities and enhance security in all CDC
locations.
CONCLUSION
In conclusion, CDC is committed to working with other Federal agencies as well

as State and local public health partners to ensure the health and medical care of
our citizens. We have made substantial progress to date in enhancing the nations
capability to prepare for and respond to public health threats and emergencies, in-
cluding bioterrorism events. The best public health strategy to protect civilians
against any health threat is the development, organization, and enhancement of
public health systems and tools. Priorities include a fully staffed, fully trained, and
properly protected public health workforce, strengthened public health laboratory
capacity, increased surveillance and epidemiological capacity, secure up-to-date in-
formation systems, solid health communications capabilitiesall supported by flexi-
ble policies and preparedness plans that enable the public health system to prepare
for and respond to any type of health emergency at the Federal, State, and local
level. Not only will this approach ensure that we are prepared for deliberate bioter-
rorism threats, but it will also ensure that we will be able to recognize and control
any threat to the publics health. A strong and flexible public health infrastructure
is our best defense. The Administrations Emergency Response Fund request is an
important step in this process and we encourage you to support it.
At this time, I would be happy to answer questions from you and Members of the
Committee.
Senator HARKIN. Thank you very much, Dr. Koplan.
Dr. Fauci.
210
STATEMENT OF ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTI-
TUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL IN-
STITUTES OF HEALTH
Dr. FAUCI. Mr. Chairman, Senators Specter, Stevens, Kohl:
Thank you for calling this hearing and thank you for giving me the
opportunity to testify before you. As you have just heard from Dr.
Koplan, the effort to address bioterrorism is out of necessity a com-
prehensive and multi-faceted endeavor involving multiple Federal
agencies, several sister agencies within the Department of Health
and Human Services, as well as other agencies such as the Depart-
ments of Defense and State, local health departments, and, impor-
tantly, private industry.
The NIHs role in this important comprehensive approach is a
very specific one and that is addressing the biomedical research
component of the counter-bioterrorism effort. We do that with basic
researchI will talk about that very briefly in a momentand we
aim to develop and apply basic research to the production of
diagnostics, therapeutics, and ultimately vaccines.
We have emphasized, together with the CDC, a number of mi-
crobes that we call Category A microbes that are, in our esti-
mation, of the highest risk and greatest impact. Among these are
anthrax, smallpox, plague, botulism, tularemia and the hemor-
rhagic fevers. In the interest of time, I am going to focus my very
brief discussion on the NIH research efforts addressing smallpox
and anthrax.
First with regard to smallpox, as I testified a short time ago be-
fore this committee, we have embarked on dilutional studies to look
at the already-owned stock that the Federal Government has under
the auspices of the CDC, the 15 million doses, to determine if by
diluting them one-to-five or one-to-ten we can preserve the potency
as well as expand the numbers. This study is proceeding extraor-
dinarily well. We have an encouraging high rate of takes. A
take is an indication that the potency still remains, even when
the vaccine is diluted. I will be happy to discuss this a little bit
later.
You heard yesterday the announcement of the letting of the con-
tract by Secretary Thompson to Acambis and Acambis-Baxter to
have 155 additional million doses of a second-generation vaccine to
supplement those that we already have contracted for. Together
with the dilutional group, this will allow us to have vaccine avail-
able if necessary to give to everyone and anyone in the country.
Importantly the NIH research effort also includes third-genera-
tion vaccines, namely the molecular biological approach of looking
at purified sub-units that would obviate the concern regarding
toxicities of using a live virus. This is years away, but it is one of
those future things that we need to approach because this would
make it safe for all populations.
We also have an antiviral screening and development program.
You have heard of the drug Cidofovir. I mentioned this at the last
hearing. It is a drug that we originally developed for the purpose
of treating cytomegalovirus infection in HIV-infected individuals. It
is now shown in the test tube and in animal models to be highly
effective against a variety of pox viruses. We are pursuing this in
211
investigational new drug applications to determine its capability

against disseminated vaccinia and ultimately smallpox.
Moving on to anthrax, the NIHs role is to cooperate with our sis-
ter agencies, CDC, USAMRIID, and others, together with the FDA
to develop a recombinant protective antigen anthrax vaccine that
we could use as a second- and third-generation vaccine. Also, there
is a considerable amount of basic research done on the anthrax mi-
crobe itself to answer somenot all but someof the questions
that Senator Stevens just brought up.
Integral to our research effort again is another area that we have
been working on for a considerable period of time that significantly
antedated the September the 11th tragedy. That is the sequencing
of the full genomes of pathogenic microbes, including smallpox, an-
thrax, and several others. The reason that this is important is be-
cause this approach gives us a very specific target for the develop-
ment of diagnostics, therapeutics, and vaccines.
Very briefly, there are other agents that I alluded to. We do not
have time to go into them right now, but one of them in particular
is the group of hemorrhagic fevers, including Ebola. We have a pro-
gram at the NIH in the Vaccine Research Center of the NIAID that
has shown very convincingly in a non-human primate model that
a recombinant type of second-third-generation vaccine was able to
protect these non-human primates against Ebola. We are moving
as rapidly as we can to get that into phase one trials.
Having said all of this, much still needs to be done because there
are many unanswered questions and we need to address these as
quickly as we possibly can.
In summary, the NIH is focusing our basic and applied research
resources on bioterrorism. We have at the intramural research pro-
gram at NIH, and in our extramural community of very talented
investigators whom we support with grants and contracts, the
worlds experts in the science of countering bioterrorism. Together
with our sister agencies such as the Centers for Disease Control
and Prevention, we commit ourselves to meeting this most extraor-
dinary and historic challenge to the health of our Nation.
PREPARED STATEMENT
I would be happy to answer any questions, Mr. Chairman. Thank

you.
PREPARED STATEMENT OF ANTHONY S. FAUCI, M.D.
Mr. Chairman and Members of the Subcommittee, thank you for inviting me here
today to provide an update on the current bioterrorism research activities of the Na-
tional Institutes of Health (NIH) and our plans for the future. Any program that
will effectively counter bioterrorism out of necessity would be a comprehensive pro-
gram involving multiple government agencies, local and State health departments,
and private industry. An important component of such a comprehensive effort is bio-
medical research. The role of the NIH in the overall government effort against bio-
terrorism is to conduct and support such research.
The NIH bioterrorism research program is spearheaded by the National Institute
of Allergy and Infectious Diseases (NIAID) and encompasses four broad areas: basic
research, diagnostics, vaccines and therapeutics. I would like to briefly describe our
research in these broad areas as well as summarize several specific NIAID-sup-
ported smallpox and anthrax studies.
Research into the basic biology and disease-causing mechanisms of pathogens un-
derpins efforts to develop interventions against agents of bioterrorism. NIH supports
212
research to better understand the factors that influence a pathogens virulence and
invasiveness, as well as those that determine antibiotic resistance. NIH also sup-
ports research on the host/pathogen interactions. Knowledge from basic research
findings is crucial to the development of preventative and therapeutic strategies.
One of the most important basic research tools that has evolved in recent years
is the ability to rapidly sequence the entire genomes of microbial pathogens, includ-
ing potential agents of bioterrorism. Some agents, such as smallpox and other
orthopoxviruses related to smallpox, have already been sequenced; the sequences of
others, such as Bacillus anthracis (the anthrax bacterium) and other bacteria rel-
evant to bioterrorism are in progress and close to completion. The fruits of genomics
research, coupled with other biochemical and microbiological information, are ex-
pected to facilitate the achievement of critical new goals, including the discovery of
new targets for drugs and vaccines. In particular, comparative genomics (comparing
the sequences of different strains of particular organisms) will be an important com-
ponent of future research, helping us to understand what makes a particular orga-
nism either harmful or benign.
NIH also supports research leading to the development of new and improved
diagnostics. The goal of this research is to establish methods for the rapid, sensitive,
and specific identification of natural and bioengineered microbes as well as the de-
termination of the microbes sensitivity to drug therapy. These scientific advances
will allow health care workers to diagnose and treat patients more accurately and
quickly.
NIH-supported researchers are developing vaccines that are effective against
many infectious agents, including those considered to be bioterrorism threats, with
the intention of developing products that are safe and effective in civilian popu-
lations of varying ages and health status. Vaccines against pathogens are being de-
veloped using both traditional and novel technologies. Some novel technologies in-
clude the development of DNA vaccines, various vector vaccines, and innovative
systems for the rapid creation of vaccines against unfamiliar or genetically altered
pathogens; these technologies are in various stages of development.
NIH therapeutics research focuses on the development of new antimicrobials and
antitoxins, as well as the screening of existing antimicrobial agents to determine
whether they have activity against organisms that might be employed by bioterror-
ists. Knowledge gained from basic and applied research is helping to identify addi-
tional targets for medications against agents of bioterrorism. The design of thera-
peutic drugs active against known drug-resistant variants of microbes, and the de-
velopment of broad-spectrum agents are also important NIH research priorities.
Together, these efforts create the strong foundation from which the NIH carries
out bioterrorism research activities. Two cogent examples of this multifaceted re-
search approach are the specific NIH projects in the areas of smallpox and anthrax.
Smallpox is considered one of the most dangerous, potential biological weapons be-
cause it is easily transmitted from person-to-person, and very few people carry full
immunity to the virus. Historically, the mortality of smallpox infection has been ap-
proximately 30 percent; those patients who recover frequently have disfiguring
scars.
NIAID research on smallpox focuses primarily on extending existing vaccine
stocks to increase the number of available doses, and developing new vaccines and
treatments for the entire population, as well as diagnostic tools to detect the disease
quickly.
At present, the approximately 15 million doses of the traditionally employed and
highly effective Dryvax vaccine that have been stored since production stopped in
1983 would not be enough to respond to a national smallpox epidemic. In response
to this shortage, NIAID initiated a study last year to determine the feasibility of
expanding the use of the existing stores of the Dryvax vaccine by dilution. In this
study, investigators examined and compared the skin and immune system responses
of normal unimmunized adult volunteers who were given undiluted Dryvax vaccine,
a 1:10 dilution (10 percent) of vaccine or a 1:100 dilution (1 percent) of vaccine. The
results showed that the full-strength vaccine had maintained its potency, and that
70 percent of people who received a single dose of the 10-percent diluted vaccine
developed a sore followed by a scab at the injection site and antibodies in their
blood, strongly suggesting protection. The 1:100 dilution had an unacceptably low
take rate.
Based on these findings, a larger study is underway to determine the best strat-
egy for optimal use of available vaccine. This study, which will enroll up to 684 peo-
ple, is evaluating three different doses (undiluted, 1:5, 1:10) of Dryvax. Researchers
will study the ability of the various vaccine formulations to stimulate a scab, or
take, at the vaccination site and to produce neutralizing antibodies in the blood.
If participants have not developed a scab in seven to nine days after vaccination,
213
they will be revaccinated with the same vaccine dose they received the first time.
By that strategy, researchers hope to learn which vaccine dose given in a single in-
jection elicits the desirable response among the largest number of people and wheth-
er boosters can increase the take rate on a population basis.
NIAID is also designing clinical protocols for testing of Dryvax in previously im-
munized adults and in children. At the same time, we are investigating the newer
cell culture based smallpox vaccines as well as alternative vaccination strategies
with the goal of designing safer and more effective vaccines.
NIAID/NIH also supports long-established contracts that conduct in vitro and in
vivo screening of known antiviral compounds to determine if they are effective
against viruses that are similar to smallpox (vaccinia virus and cowpox virus). Com-
pounds with promising in vitro activity are further evaluated in animal models of
orthopoxvirus infection by both United States Army Medical Research Institute of
Infectious Diseases (USAMRIID) and NIAID-supported investigators. To date,
NIAID and USAMRIID have screened approximately 500 compounds. The drug
cidofovir has been shown in multiple test systems to have activity against all
orthopoxviruses tested in vitro and in vivo. NIAID submitted an Investigational
New Drug (IND) application for use of this drug as a backup to vaccinia immune
globulin (VIG) in our dilutional vaccine studies and possibly for the emergency
treatment of smallpox should a bioterrorism attack occur.
One key collaborative activity that will accelerate the development of new treat-
ments and vaccines for smallpox is the recent establishment of the Orthopoxvirus
Genomics and Bioinformatics Resource Center. NIAID, the Defense Advanced Re-
search Projects Agency (DARPA), the Centers for Disease Control and Prevention
(CDC), USAMRIID and the American Type Culture Collection have all contributed
toward this Center, which will conduct sequence and functional comparisons of
genes to provide insights for the selection of targets for the design of antivirals and
vaccines.
With regard to anthrax research, NIAID has been collaborating with the Depart-
ment of Defense (DOD) to support the development of the next generation of an-
thrax vaccines that may be more appropriate than the current anthrax vaccine for
use in the civilian population. At present, we are currently planning Phase 1 safety
and immunogenicity trial for the USAMRIID recombinant protective antigen (rPA),
one of the leading anthrax vaccine candidates. In addition, NIAID is utilizing its
vaccine production and support contractor, Science Applications International Cor-
poration (SAIC) to facilitate and expedite the development of additional rPA vac-
cines.
NIAID is also exploring rapid diagnosis of anthrax and the utility of available
antimicrobial or antitoxin therapies. Together with the Food and Drug Administra-
tion (FDA), CDC, and USAMRIID, NIH is working to prioritize and accelerate test-
ing of existing antimicrobials for use against anthrax. Last month, NIAID-supported
investigators published two studies in the scientific journal Nature that help to ex-
plain how anthrax toxin destroys cells. In the first study, researchers have identi-
fied the site on the cell that binds the anthrax toxin and have developed a com-
pound that may disable it. Another group of investigators has characterized the
structure of a major component of the anthrax toxin. The information gained
through these studies will likely hasten the development of new drugs to treat an-
thrax.
In addition, the NIAID, through an Inter-Agency Agreement with the Office of
Naval Research, has provided funds to help complete work on sequencing the ge-
nome of B. anthracis. The information derived from this genome-sequencing project
should be of great value in developing rapid diagnostic tests, as well as new vac-
cines and antibiotics therapies against mutant strains of B. anthracis.
Although the focus of national attention has been on smallpox and anthrax, we
must not overlook other organisms of bioterrorism, including agents that cause
plague, tularemia, botulism, and viral hemorrhagic fevers. NIH-supported research
is yielding insights in these areas. For example, intramural investigators at NIAIDs
Dale and Betty Bumpers Vaccine Research Center have developed a DNA vaccine
that has protected monkeys from infection with Ebola virus; this vaccine could soon
enter human trials.
Together with our many research partners, NIH has made substantial progress
in the research effort that is critical to our Nations fight against emerging diseases,
including those that are intentionally released as agents of terrorism. In addition
to previously mentioned collaborations with other government agencies, NIAID
maintains important partnerships with industry that are essential to the develop-
ment of new technologies and treatments in the arena of infectious diseases.
Much remains to be accomplished, however, and the challenges posed by bioter-
rorism will require a sustained commitment over the years to come. Within the next
214
few weeks, NIH will announce new initiatives for funding in fiscal year 2002 to pro-
vide the academic and industrial research communities with an opportunity to pro-
pose studies targeting new approaches to research on agents of bioterrorism. For ex-
ample, we will unveil an initiative entitled Partnerships for Novel Therapeutic, Di-
agnostic and Vector Control Strategies in Infectious Diseases, which will involve
substantive involvement by a private sector partner and focus on areas that are cur-
rently not a high priority or that may be too financially risky for industry to pursue
alone, but are likely to have a high impact on public health. The submission, review,
and funding of these proposals will be expedited in order to facilitate the rapid ad-
vance of these important research endeavors. This information is being made avail-
able to the public and the research community through our website.
With a strong research base, talented investigators throughout the country, and
the availability of powerful new research tools, we fully expect that our basic and
applied research programs will provide the essential elements that will greatly en-
hance our defenses against those who attempt to harm us with bioterrorism.
That concludes my testimony. I would be happy to respond to any questions that
you might have.
Senator HARKIN. Thank you, Dr. Fauci.
I wonder if I could start with you, Dr. Fauci. To go back over
smallpox, I would like you to, if you could, in just a little more de-
tail outline for us the proposal that Secretary Thompson made late
yesterday afternoon. I spoke with him personally myself yesterday.
As I understand it, negotiations have been finished, and there will
be, what, three companies that will be supplying the smallpox vac-
cine?
I am not so much interested in all the minute details. What I
really want to know is, give us a time line and let us know, how
soon will you be able to tell us whether the 15.4 million doses that
we have stockpiled now could be used for, let us say, up to maybe
seven, eight times that much, depending on the dilution? How soon
will we know that?
How soon will we have enough vaccines available for every per-
son in America? How soon we will have that built up under the
agreement that was made yesterday?
Dr. FAUCI. First of all, it is not three companies, Mr. Chairman.
The companies involved are the company Acambis that we had al-
ready contracted with initially to make 40, but then changed to
over 50 million doses of the second-generation vaccine. They have
combined with a large company called Baxter. So to avoid confu-
sion, there is the Acambis contract that had already been let, and
then there is the Acambis-Baxter contract which was announced by
Secretary Thompson yesterday.
So let me run through your questions briefly and tell you how
we are going to get to the total number of doses that you refer to.
The dilutional study that started at the end of October, in which
we are looking at that 15 million doses to see if we could stretch
them out, we are doing a one-to-five and a one-to-ten dilution. We
have vaccinated essentially everyone with just a few to go in the
original 684. The take rate is extraordinarily high.
Senator HARKIN. That is undiluted?
Dr. FAUCI. That is, no, on all of them.
Senator HARKIN. All of them.
Dr. FAUCI. We cannot tell you exactly and I do not want to make
any announcement of results because you have to scientifically ex-
amine them, put them to peer review, look at the antibody titers
that we do not have yet. We are just looking at take rate, and our
experiments over the years tell us that take rates coincide very
215
well with the production of the antibodies that you would like to
induce.
So it is not final yet, but things are looking quite good. We will
have those results in their final form by the end of January, the
very beginning of February. Let us assume that the dilution one-
to-five does in fact give you a high rate of induction of immunity.
That then would provide us with about 75-plus million doses. So
that is one component of the totality of doses.
We have a contract with the CDC and Acambis, that has been
going on for a considerable period of time, with the original target
to get 40 million doses by the beginning of the year 2004. That has
been markedly upscaled to now deliver 54 million doses by the end
of the year 2002. That is another 54 million. So it is 75 and 54 mil-
lion.
Then you have what you heard about yesterday, the 155 million
doses in which Acambis and Baxter together are going to give us
that second generation smallpox vaccine. They are now going to be
having pilot lots probably by the beginning of the year, later winter
or so. Then there will be an accrual, that each month that goes by
there will be that many more tens of millions of doses, so that by
the time we get to late fall, perhaps early winter of 2002, we will
have the totality of doses that you referred to, which would be
about 280 million some odd doses.
Senator HARKIN. Do you knowI do not know if you are the
right person to ask this question, but is the idea then that these
vaccines would be distributed around the United States at various
locations? Is that the idea?
Dr. FAUCI. The idea is to have them in reserve. I will defer to
Dr. Koplan, since the CDC plays such a major role, not only in the
advice about how and when and where to vaccinate, but also in the
distribution. So if I could pass that over to Dr. Koplan, he could
answer that.
Dr. KOPLAN. Thanks.
We have already begun discussions on the appropriate deploy-
ment of amounts of vaccine as they become available. What will
happen is in the coming months we will have broad public discus-
sions with academicians and scientists from both within the gov-
ernment and outside the government, from academia, elected offi-
cials, Congress, and discuss the pros and cons of the various alter-
native ways of dealing with having a vaccine for which currently
there is no naturally occurring infection, but for which there might
be a threat of its use as a bioterrorism agent, and the level of that
threat is quite unknown at this time.
The issues that will be involved in that discussion are complex
and they involve: one, the issue of should there be a mandatory
vaccination, should everyone have it? If that were true, does it then
get repeated every year for new people who have not been vac-
cinated?
This is a vaccine which has a low rate of side reactions to it, but
a real and a predictable rate of side reactions to it. Some of them
are not just significant reactions. Some of them are severely dam-
aging and some of them result in death. So if you use this vaccine
in a million people, you can expect a half dozen or more to be se-
216
verely enough injured from the vaccine to be hospitalized and some

number of those to die from it.
So in a widespread use of the vaccine, there will be hospitaliza-
tions, there will be people with permanent damage, and there will
be deaths. So that has to get balanced with what one considers the
threat of an introduction of smallpox. This will take place over the
coming months as the amount of vaccine is increased in the coun-
try.
We have a mechanism for determining immunization policy in
this country using the ACIP, the Advisory Committee on Immuni-
zation Practices, which has served us well over decades now and
has resulted in the lowest rates of disease from immunizable ill-
nesses that has ever been seen in the world. So they would I think
play a major role as well in this.
Senator HARKIN. Thank you, Dr. Koplan. I want to come back
and ask you about that later. I see my time is up right now, but
I want to ask about Cidofovir and the stockpile, if we are going to
stockpile that drug, later on.
Senator Specter.
Dr. Koplan, on October 23rd at our bioterrorism hearing I asked
you to furnish a list of all the threats and the costs involved. I
would like now your professional judgment on what we need to ap-
propriate now to meet all the bioterrorism threats.
Dr. KOPLAN. Thank you, Senator Specter. I am happy to offer my
professional judgment. Of course, you will all recognize that it is
not constrained by the competing priorities that the President and
his advisors must consider.
Having said that, a major area for upgrade is State and local
health capacity. You have heard that from, I think, your own re-
spective States, wherever they are, and that this is really where
things start in a bioterrorist event. It started in Palm Beach Coun-
ty, Florida; it started in New York City.
Senator SPECTER. Dr. Koplan, I have got 5 minutes. What is the
cost?
Dr. KOPLAN. Okay. Basically, roughly between $15 and $20 mil-
lion per State is needed to get them up to running speed for this.
Senator SPECTER. Total national?
Dr. KOPLAN. For a total of about $1.050 billion for States.
Senator SPECTER. What is next?
Dr. KOPLAN. Upgrading CDC capacity, including our biological
capabilities and laboratories and chemical needs, is roughly $150
million.
Senator SPECTER. I am convinced of that. I have seen it myself.
Next?
Dr. KOPLAN. The national pharmaceutical stockpile we want to
enlarge. We want to add anti-botulism items. We want to increase
trauma supplies, etcetera. That is about $640 million. We will add
four more pushpacks to bring the total to 12 from 8 that we had
before.
For the vaccine purchase that you have heard Dr. Fauci just de-
scribe, there are also some implementation figures that might be
helpful for States. In other words, it is not just having the vaccine
present in a warehouse. It is how do they get them out to commu-
217
nities. We can work with your staff to give an estimate of that

number, but that will require a little more research.
Senator SPECTER. What is your professional estimate at the mo-
ment?
Dr. KOPLAN. I would guess it is probably somewhere between
$600 and $700 million for the extra expenses beyond just producing
the vaccine.
For laboratory security, principally at CDC, at four of our cam-
puses that have biological agents present, roughly $96 million
would be required for laboratory security improvement.
Then finally, for efforts related to the events of the last several
months, where lots of expenditures have been made and lots of
needs have been accrued by the localities in which these bioter-
rorist and terrorist events have occurred, roughly $50 million.
Senator SPECTER. Did you cover smallpox?
Dr. KOPLAN. Smallpox is handled within that vaccine, the area
that I just mentioned, $600 to $700 million.
Senator HARKIN. $600 to $700 million.
Dr. KOPLAN. Plus the purchase, not including the purchase cost.
Senator SPECTER. So what would the total need be for the pur-
chase of vaccines?
Dr. KOPLAN. Well, the purchase of vaccines, as Dr. Fauci just in-
dicated, is the $500 million figure for purchasing these new vac-
cines.
Senator SPECTER. I had been informed that the smallpox vaccine
would cost $1.4 billion.
Dr. KOPLAN. I am saying the purchase of the vaccine itself is
roughly $500 million, but then there are other expenses in terms
of getting it out to States and localities, having people prepared to
use it, and having training for those people. There also has to be
vaccinia-immune globulin.
Senator SPECTER. Then is the $1.4 billion figure accurate or not?
Dr. KOPLAN. I think that is a little high because of the negotia-
tion and the lower price we got on the vaccine that was announced
yesterday.
Senator SPECTER. How much would you take off the figure then?
Dr. KOPLAN. I would probably take off $600 million off of that,
based on the way we have been able to package vaccine and get
it up to 300 million doses.
Senator SPECTER. So $800 million instead of $1.4 billion?
Dr. KOPLAN. Exactly.
Senator SPECTER. The release by the Secretary yesterday on the
expenditure of some $428 million, that has to be appropriated. The
Department does not have that money, correct?
Dr. KOPLAN. I believe that has to be appropriated, correct.
Senator SPECTER. So he is contracting for it without authoriza-
tion, without an appropriation from Congress, and I congratulate
him for doing so.
You did not answer the question, Dr. Koplan, and you do not
have to.
Dr. Fauci, the same question was put to you. What are the needs
for NIH to have adequate funding for bioterrorism?
Dr. FAUCI. In our original request that is contained in the Presi-
dents budget, Senator Specter, we had accelerated up to $92.7 mil-
218
lion. As things have evolved since the time of that submission I

would have to give you my professional judgment of what we would
need to meet what I feel are the scientific and public health needs
that the NIH can address. As Dr. Koplan said, I would have to say
that this judgment is not constrained by those other priorities of
the President and his advisers.
But in my professional judgment we would have to do signifi-
cantly more than that. If you look at bioterrorism prevention, treat-
ment, vaccine and other basic research, not only in smallpox, an-
thrax, and other microbes, together with the secure facilities that
we would need, what we call BL4 facilities, to work with the ma-
terial that we would ultimately have to work with, as well as other
physical security measures and continuation of part of the smallpox
vaccine program, it is going to depend on when we get it. But I will
give you specific numbers, because if we could do it immediately it
would be something that would be more front-loaded.
If you are talking about the number that we could clearly do
the kinds of research that I think are implementable right now
we are talking about a total additional number above the $92.7
million that ranges from $175 million to more than $200 million,
again depending on when and how we get it.
If you add the kinds of things that we need
Senator SPECTER. The question is how much do you need and can
you put it to use now?
Dr. FAUCI. Right now, we could put to good use between $175
million and $200 million, in addition to the $92.7 million that we
asked for.
Senator SPECTER. That sounds to an appropriator like $175 mil-
lion. Will that meet your needs? If you are going to give us a range
of $175 million to $200 million, we are not going to give you the
top figure; we are going to give you the bottom figure. I just want
to be sure that is what you need.
Dr. FAUCI. We could adequately spend up to $200 million.
Senator SPECTER. Dr. Koplan, on the figures you have given, is
there room for a first installment or is that the money you need
now to move ahead with an adequate response to bioterrorism?
Dr. KOPLAN. I think we are facing risks now and the sooner
these funds beef up State and local health departments, the sooner
we are better prepared.
Senator SPECTER. So you have a need to expend them now?
Dr. KOPLAN. Yes.
Senator SPECTER. Thank you.
Senator Kohl.
OPENING STATEMENT OF SENATOR HERB KOHL
Senator KOHL. Thank you, Senator Harkin.

Dr. Koplan, I would like to talk with you about the immunization
program for the vast number of people who we would describe as
the caregivers in the event of an outbreakphysicians, nurses, peo-
ple who work in hospitals around the country, other local public
health officials. I am assuming that in order for them to provide
219
the kind of service that would be necessary in the event of an out-

break they would need to be immunized beforehand.
Number one, is that true? Number two, what is the program that
is on the table to immunize the caregivers of this country? Number
three, how long does it take to provide that immunization to an in-
dividual, a day, a week, a month? How is this going to unfold and
how quickly is this going to unfold?
Dr. KOPLAN. Thank you, Senator Kohl. We are trying to deter-
mine who would most benefit from vaccine. There are a range of
both caregivers and non-caregivers who could potentially be ex-
posed. One of the aspects of smallpox is that in the first 4 days
after exposure to the disease you can still get the vaccine and be
fully protected from it. So, unlike some other diseases where you
have to get the vaccine days, weeks, or months ahead of time,
smallpox is different. You begin to produce antibodies right away.
Another method of protection against smallpox is not just vac-
cine, but the type of isolation procedures that hospitals routinely
use for a wide variety of other diseases and that can protect their
staff, including the use of face masks protective against smallpox
dissemination.
Nevertheless, having said those two things, what we are in the
process of now, we have just put out a draft version of a national
smallpox bioterrorism plan, if you will. That was created in co-
operation with State and local health partners. What we are going
to be doing is meeting, talking with them, with physician groups,
nursing groups, etcetera, to determine just what you said, who are
the groups that would most benefit from early vaccination with
smallpox vaccine.
Senator KOHL. All right, I appreciate that. But if we have an out-
break tomorrow or next week, are the caregivers of this country
prepared to provide their services?
Dr. KOPLAN. Yes. If we have an outbreak todayfirst of all, the
outbreak begins with the recognition of a case or two, that is the
way all outbreaks begin. At that point, local and State investiga-
tors would be on the spot, getting specimens, determining what is
going on, and also identifying what had been exposed to that indi-
vidual. All those individuals would be getting vaccine and we would
go in increasing rings around that individual who had been ex-
posed.
Senator KOHL. Yes, but dont those people need to be immunized
in order to provide the kind of services that will be necessary?
Dr. KOPLAN. No, they do not. They can provide those services. I
am not currently immunized and I would not hesitate to provide
service to someone who came in with a rash or an illness, as long
as I know that within 4 days after I have had that exposure I can
get vaccinated.
Senator KOHL. You said that is true with respect to smallpox?
Dr. KOPLAN. That is true for smallpox.
Senator KOHL. What about other communicable diseases?
Dr. KOPLAN. Some of the other diseases that we worry about,
rather than vaccines, we have antibiotics that are effective against
them. But I think the key item in every one of these things that
you are raising and appropriately raising is the speed of diagnosis.
That is what makes all the difference in every one of these out-
220
breaks. It is how quickly you could identify those first cases, be-
cause particularly in diseases, unlike anthrax which cannot be
spread from person to person. But some of the other diseases that
we would worry about, such as smallpox and some others, are
spread from person to person.
So the speed of that first diagnosis is crucial in limiting the
amount of spread of disease.
Senator KOHL. Well, do we intend to immunize in advance those
several hundred thousand primary caregivers around the country?
Dr. KOPLAN. I think that is a subject for discussion. As we get
more doses of vaccine available, certainly more and more people
can and ought to be considered. It is not just the primary care-
givers. Once you get into a hospital emergency room, it includes
maintenance staff and cleanup crews and people that come in and
out, and there is turnover of all these individuals.
As I indicated before, the thing one has to keep in mind with
something like smallpox vaccine is it is a live vaccine which is
present on the skin surface. With its rates of side reactions, people
who are immunosuppressed, who are HIV-positive, may have se-
vere reactions to this vaccine. In addition, people working in hos-
pital environments where there are sick people around may have
to leave work for a period of time while that vaccination takes
place because of the live virus present; they may not have to, but
some may.
So these are all complicating issues when you talk about health
care providers getting the vaccine. There is a tradeoff. If they abso-
lutely need it, then they need to get it. But where the risk is un-
clear, there are also dangers attached to providing the vaccination,
and it is these benefits and risks that have to be taken into balance
and will be discussed with both clinicians and clinician groups and
with public health people in the States.
Senator KOHL. Are you prepared to recommend that this group
be immunized in advance at this time, next week, next month?
Dr. KOPLAN. No, I am not prepared to make that recommenda-
tion. But we are certainly eager to have discussions with both these
people who would be involved and the people in the States and see
what the consensus is on what policy would be best.
Senator KOHL. Thank you.
Thank you, Senator.
Senator HARKIN. Thank you, Senator Kohl.
Senator Stevens.
Senator STEVENS. Doctors, let me first start by making a short
statement, and that is this. We are dealing with bills now that will
probably not be signed until Christmas. Monies could not be re-
leased until at least January. We will be through at least one quar-
ter of the fiscal year.
The figures you have just given the chairman and Senator Spec-
ter I assume were annual expenditures, or were they expenditures
for several years?
Dr. KOPLAN. Those were annual.
Senator STEVENS. Could you give us a statement of how much
you believe you need to pay out, not commit, pay out between now
and May and between now and the end of September? I do not
want it right now, but we are dealing with a lot of tight money
221
right now and we have got to stage it if we are going to get the
money we need to you as it is needed. There is great fear that we
are just dumping money out the window and people do not know
exactly what it is for and therefore people are afraid that we are
going to waste money. We all read the papers about the terrible big
spenders around here and I usually head the list, but I do not be-
lieve we are. But we want to be very specific.
Now, my first question to you is, we have been visited, I think
most of us have been visited, by a group that believes that they can
develop a heteropolymer system that uses monoclonal antibodies to
bind pathogens in the blood and transport them to the liver, where
they can be cleansed and removed from the body.
Now, I do not know enough about the science, and I assume you
do. But we have been told there is money in the budget, there has
been money in the budget the last 2 years dealing with this. But
we have been told that that process might be accelerated. I am par-
ticularly concerned with the people we send in harms way, our
military, and they said they could prepare what could be called a
cocktail of such heteropolymers that could provide broad spectrum
protection for people against a series of substances.
Now, do you know about this research and are either of you pur-
suing funding it?
Dr. FAUCI. The principle that you are referring to is a mechanical
and physical chemical way, as you mentioned correctly, to bind to
any organism, essentially, and get it cleared out of the body. The
NIH, as in the past, enthusiastically now and in the future, will
be happy to examine any proposal in the classical peer-reviewed
way to determine if in fact it is something that can be and should
be funded.
If we do not have a proposal in front of us, we cannot evaluate
it. To my knowledge, that proposal has not reached us. But if it
has, we would be more than happy to expedite looking at it.
Senator STEVENS. Well, I have been specifically requested to allo-
cate portions of the defense budget to that immediately, because we
still have the defense bill with us. I think that is why they are
looking at the defense budget.
But we are also told that that research, with sufficient funding,
now could be accelerated so that those substances might be avail-
able by 2003. If that is possible, we were further told that these
substances could protect an individual for up to 60 days against the
substance that might otherwise seriously harm or kill them.
I think we need to know about things like this because if this has
less risk to the populace by using a temporary substance it might
even bypass the problem we previously discussed of the risk to peo-
ple with HIV or damaged immune systems from even things like
smallpox.
All I can tell you is I hope you will look into it. I do not know
what the cost would be, but clearly it would be much better to have
people in the service have a vial that they could use, like we used
to use morphine, and just self-administer it and have protection in
the event they were told that substances had been released at them
that might otherwise kill them.
I really think we are in a crisis period as far as they are con-
cerned. Our people up here at home, we might have a better way
222
for civil defense than they do for defense militarily. So I would urge
you to take a look at it.
Dr. FAUCI. If I can get something to look at, I would be happy
to look at it, Senator.
Senator STEVENS. I will see that they get to you.
Dr. FAUCI. Thank you.
Senator STEVENS. I think we need someones judgment before we
move to earmark defense money for this. There is just not enough
available to me so far.
Secondly, let me ask you this. I am running out of time. Could
I have another minute?
Senator HARKIN. Yes, sure.
Senator STEVENS. I asked yesterday a series of questions about
these substances in our building, about how far these spores can
travel, have traveled, whether they have traveled further as
minute particles than they would in the normal run of the mill an-
thrax, and what exposure we could expect our people to have if
they go back into offices that may or may not have been exposed
to this anthrax.
Now, my offices are on the fifth and sixth floor of the Hart Build-
ing. They are at the other end of the building from Senator
Daschle. But clearly the question is what does the air system dis-
tribute and where do these things go. My friends from ranch coun-
try tell me they go to the ground. But these people have been leav-
ing petri dishes around to see if spores are there. Everyone I have
talked to says they may go to petri dishes, but they are going into
the ground if it is there, and if it is not they are going where it
is dark and dirty.
Now, we have not been looking where it is dark and dirty. We
have been putting petri dishes out on the tables, as I understand
it.
Can you clear that up for us? We really seriously have a group
of young people who are going back into these buildings before
Christmas probably and they are not satisfied with our expla-
nations.
Dr. KOPLAN. Let me try. For one, I think there is frustration for
all of us because we do not have all the answers and we do not
have all the science for this. But for one, the EPA is responsible
for the cleanup of the Hart Building and we are providing technical
consultation.
Senator STEVENS. Doctor, they say you are responsible for the de-
gree of safety in the buildings and determining whether it is clean
or not.
Dr. KOPLAN. We are providing technical support to the EPA, and
I will tell you everything I know.
Senator STEVENS. Do you accept responsibility for saying if the
Hart Building is clean or not? Are you going to be the one that de-
termines that?
Dr. KOPLAN. I think by statute the EPA is. We are working with
them on a daily basis and this is an area that they have got long-
standing expertise in, which is building cleanup and safety. We are
involved in this to provide information on the anthrax.
Senator STEVENS. I am talking about the standards of what is
clean.
223
Dr. KOPLAN. There are no standards, Senator.

Senator STEVENS. They are telling us that you are going to set
them.
Dr. KOPLAN. Well, it is hard to set them in the absence of sci-
entific information. This is why it is frustrating for all of us. But
if I can continue, the issue here is to get rid of all the anthrax
spores that we can through some process that gets rid of them.
Your question is, well, how do you know where they are and how
do you measure that?
The putting around of those petri dishes is appropriate because
if you are on a ranch or you are on a farm, you look for anthrax
in the soil or on cattle, but if you are in a room like this or in our
homes or anywhere you might go, the spores exhibit a physical
phenomenon: they drop to wherever they drop. They can drop in
the plants and in the soil, yes. But they can also drop on a desk,
and if there is a crevice on a piece of furniture they are as likely
to be there as anywhere else.
It is not that they gravitate to soil. That is where they are found
naturally. So when your folks outside talk about where you find it
outside, yes, that is where it is naturally found, but not when it
has been purposely spread in an office building.
Yes, it does spread through air ventilation systems and one of
the things that has been done in Hart and other buildings has been
to put petri dishes around in other places in the building to see
where it has spread and to take specimens from walls, vents, fil-
ters, et cetera, to see where it has gone.
Really, the best measure of your first question of how far does
it go, how do we know how fast it travels someplace, and where it
goes, is to do that measurement in different parts of the building.
That is what EPA and we have been working to do; to get those
measures and see if it is there.
If you go and do a cleanup and it is still in places, then you have
got to come back and do the cleanup again. I think none of us,
whether it is CDC or EPA or the Capitol Physician, want to see
you or any of your staff exposed to anything that can cause them
harm. We have got to come to some determination of what is a safe
level. Yes, we are working with our partners there to determine
what is a safe level. We will come visit you in the Hart Building,
too. We care about it for everybody. So we want a safe environ-
ment, a safe work environment.
The place will not be opened until it is deemed safe. You asked
a question earlier of where these things line up and how you can
find the spores; these petri dishes are the best route because that
is what they grow on. But we will keep working with EPA until
we can determine that you have got a safe work environment to go
back into.
Senator STEVENS. I am overdoing it, but let us take the Daschle
envelope. Air could carry that, it could go to the floor, people could
walk on it and they could carry that. The cart that it was on could
have carried it. A lot of things could have carried it around the
building.
Let me say, I stayed in the building almost three days after I
was there and I am one who believes it is clean now. Beyond that,
the question is assuring other people it is clean. I still do not know
224
why other things were excluded. Petri dishes are one thing. Are
you saying that you have tested some of the soils and the plants,
you have tested some of the files and the drawers, you have pulled
books off the shelf and tested them? That is not what we learned
yesterday.
Dr. KOPLAN. Let me ask and I will get back to you on that. I will
see exactly what they have tested, where they have done their
swabs. If they have missed things that should be tested, they will
have to be tested.
Senator STEVENS. Thank you very much. Thank you for your pa-
tience.
Senator Landrieu.
OPENING STATEMENT OF SENATOR MARY L. LANDRIEU
Senator LANDRIEU. Thank you, Mr. Chairman. I appreciate you

calling this hearing. I have prepared a statement that I will submit
for the record, but I would like to take this opportunity to say a
few things on the subject.
I realize that we are all on a learning curve here and really
struggling to deal with something that is in some ways unprece-
dented in our Nation. Both of you have been wonderful to testify
before our committees on several occasions and have been doing a
very good job in helping the country prepare in the event of an-
other attack.
Following up on what Senator Stevens said, could you just de-
scribe for the committee the link, the relationship or the commu-
nications you are having with our military infrastructure? While I
appreciate that this is a public health issue, it is more than just
a public health issue. It is not just your regular outbreak, obvi-
ously. It is not just an infection that has taken over the country.
This is a purposeful attack with agents that we have had very lim-
ited experience with.
The questions that Senator Stevens asked are very much on
point, I think: how clean is clean, how dangerous is the substance?
Our military for many years has had a great deal of experience in
bioterrorism, directed at protecting its own forces. All the informa-
tion that the military has about protecting its own forces from this
attack could be used very effectively in protecting the citizens of
our Nation.
So my question would be, could you both describe for the com-
mittee your current communications and relations with the mili-
tary and the Pentagon, so that we can both benefit from the exper-
tise of the military and the CDC can try to come up with a plan
that really works for the country? Dr. Koplan?
Dr. KOPLAN. Thank you. Thank you, Senator Landrieu. By the
way, on your recent visit you advised us that it really is an anthrax
attack, not an outbreak. I would like to let you know we use that
expression now regularly ourselves, because it is not a naturally oc-
curring disease outbreak.
Our links with the military actually go back some ways and so
we have got a very good and close working relationship scientist-
to-scientist and then at higher levels as well. The new Assistant
225
Secretary of Defense for Health Bill Winkenwerter and I have had

regular discussions over this.
Our close ties are with USAMRIID, the Army Medical Research
Institute for Infectious Diseases. In the earliest days of this an-
thrax outbreak, when our staff had to go to a 24-hour, 3 shift a
day, round the clock cycle, they actually lent us some of their staff,
came down, worked side by side with our people in our lab to get
the job done. That is just an example. There is a close daily work-
ing relationship with USAMRIID, and we know the folks well and
there is good communication and information gets exchanged.
As this thing progresses, there may well be the need for even
more and broader interchange for information and for staff and for
learning how things work.
Senator LANDRIEU. Mr. Chairman, the reason I raise this is as
chair of the Emerging Threats Subcommittee, our jurisdiction is
about helping the military be more prepared for these new asym-
metrical attacks. So there may be a way for us to explore a more
formal relationship between CDC and some of the experts within
the Pentagon to really help step up this homeland defense so that
these substances can be detected quickly, they can be analyzed
more quickly, the communications can be made more effectively,
and questions like Senator Stevens had can be answered in a much
more urgent fashion, so that we can counter what we hope will be
fewer attacks, but we are fairly confident there are going to be
other attacks.
So I think a more formal relationship with the military and
using their expertise, as well as leveraging the expertise of the
CDC, is something I would like to pursue with you. I do not have
a specific suggestion for this morning, but I just wanted to get that
information.
Doctor, do you have anything to add?
Dr. FAUCI. Yes. Since we are a research institution, we have very
good scientist-to-scientist interactions, particularly with individuals
at USAMRIID and other groups that do biomedical research, pre-
vention and public health out of the Department of Defense. It has
been really quite good.
In fact, before you came in, Senator, I had mentioned that some
of the collaborations, particularly in the arena of the development
of the next-generation anthrax vaccine, is done in very close col-
laboration and cooperation with the Department of Defense. So
from the scientific standpoint there is good collaboration.
I just might mention something that might be helpful to you in
your formulation about the relationship between the military and
civilian situations. Though we can learn an awful lot from them
and I encourage us all to continue to make sure that the lines of
communication are open, one of the things that is not fully appre-
ciated is the rather significant difference in the populations that
the military needs to think about and worry about when you are
talking about bioweapons, strategic and tactical, versus bioterror in
a very diverse civilian population.
If this were a theater of military operation and there was an an-
thrax attack and the attack was taken care of, you would have had
very, very healthy young men and women between the ages of 18
and mid-forties or what have you. They would have been vac-
226
cinated, they would be very robust individuals. Whether or not

there were two or three spores lying around, no one would care be-
cause of their mission.
Whereas in a situation in which you have civilians, where you
have children coming into the building, pregnant women, older in-
dividuals, that is an entirely different ballgame. So that is really
the reason why there is the frustration that Dr. Koplan alluded to,
because there really is not any experience about what is totally
safe in the setting that we are in right now.
Senator LANDRIEU. I appreciate that and I thank you. I will just
close with this, that your points about the differences are well
taken and I acknowledge that and I think it was well spoken.
PREPARED STATEMENT
But even given that, I think there are still, as we mentioned,

some great leveraging that can be done between the military and
the CDC as we stand up to this sort of new attack, or whatever
we are going to sort of call it, to get the kind of information to the
American people and get treatment and vaccines and deal with it
in a much more expedited fashion. So I thank you and look forward
to continuing to work with you on that.
PREPARED STATEMENT OF SENATOR MARY L. LANDRIEU
Mr. Chairman, again, I would like to thank you for your leadership in holding this
important hearing. As you well know, the subject of bioterrorism preparedness has
been on the minds of all Americans. Stop at any newsstand in America and you will
surely find the racks covered in newspapers and magazines with headlines that
read, How real is the threat? or Is America Ready? Stop any American on the
street and ask them to detail the symptoms and remedies for Anthrax or small pox
and no doubt they will be able to. In this new world we live in, sights of HAZMAT
suits and Cipro bottles are common.
The concern about the risk of exposure to deadly biological weapons is not just
something we have read about or seen on television. For most of us here on the hill,
our present circumstances remind us of how very real this threat is. From the time
that the letter containing Anthrax was discovered in Senator Daschles office, we
ourselves, have had first hand experiences with nasal swabs, mail tests, fumigation
procedures and antibiotic treatments. This experience forced us to question how pre-
pared are we not only to respond to a bioterrorist attack but also to prevent against
it. Finding the answers to these questions has not been easy. Like most other places
in America, we were not unprepared, but we certainly were under prepared. We
have made some good decisions and some not so good decisions, but most impor-
tantly, we have learned some important lessons. Our task now is to take those les-
sons learned and convert them into a plan for the next time, God forbid there ever
is a next time.
Websters dictionary defines the word preparation as the process of making some-
thing ready for use or service or of getting ready for an occasion, test or duty. I
mention this only because while we all use this word often, especially lately, it is
important that we focus on what being prepared really means. In the event of a bio-
terrorist attack, our public health system must be ready to serve. This system has
a duty to protect and preserve the lives of the American people. To be ready to per-
form that duty and that service, they will need guidance, assistance and resources.
Perhaps the first and most important step in the process of preparation is assess-
ing the need for improvement. A recent article in the Washington Post asked this
very question and what they found was this. A recent survey of city and county
health departments found that 80 percent of them do not have comprehensive bio-
terror response plans. A little more than half of them have plans under develop-
ment. Sixty-Two percent of these health centers responded that they were only
somewhat prepared or not prepared at all to answer the publics bioterror ques-
tions since the September 11th attacks. A 1999 survey of the city and county health
departments found serious gaps in the communication process between them and
227
the CDC. Sixty-Five percent of the CDCs e-mails were not successfully delivered to
the departments. Whats more, 55 percent of these public health agencies did not
have the capacity to send alerts to multiple recipients like health agencies, the CDC
and doctors. Finally, a 1998 study of 186 hospitals in Washington, Oregon, and
Idaho found that 88 percent of them had no plan for attacks involving biological
weapons.
These statistics show a collection of gaps that must be filled if we are to fulfill
our promise to protect the American people from harm. Filling these gaps will re-
quire time, expertise and first and foremost, resources. In fiscal year 2001, the bio-
terrorism portion of the $3.9 billion CDC budget was a mere $181 million dollars.
That is less than half of one percent. In this new world in which we now live, this
is not enough. Yet just investing more money is not the answer. We must use these
funds to make strategic investments in our public health infrastucture, national
communication and coordination systems and disease and vaccine research.
Last year, Congress passed the Public Health Threats and Emergencies Act. This
law, which I was proud to support, laid out a series of important initiatives to
strengthen the nations public health system, improve hospital response capabilities,
assure adequate staffing and training of health professionals to diagnose and care
for victims of bioterrorism, enhance our research and development capabilities and
take additional steps to prevent, prepare and respond to the threat of a bioterrorist
attack. While this bill became law, none of the programs it outlined were funded
in fiscal year 2001. At the very least, we must invest the $1.4 billion authorized by
this bill.
Mr. Chairman, as Chairman of the Armed Services Subcommittee on Emerging
Threats, I look forward to working with you, other members of this committee,
members of the House and the Administration toward ensuring that the funding
level for bioterrorism preparedness reflects its importance as a national priority. I
am interested to hear from the witnesses today, especially those from the CDC and
NIH about the extent to which they are collaborating with the Department of De-
fense and their experts in the area of bioterrorism. This threat of a biological weap-
ons war is not new to them, they have had to have been prepared for such an at-
tack, albeit under different circumstances, for quite some time. The resources, proce-
dures and information that the DOD has to offer in this area are invaluable. I en-
courage members of this first panel to make use of this resource. Most importantly,
I hope that they will work together with the DOD to reduce any duplication of effort
and thereby maximize the potential of the resources and skill offered by all the rel-
evant federal agencies.
Thank you.
Senator HARKIN. Thank you, Senator Landrieu.
Just a couple of follow-ups. I mentioned earlierI do not know
which one of you want to respond to this, but on the national phar-
maceutical stockpile, are you planning to include Cidofovir in that?
I do not know who is the proper person to ask that?
Dr. KOPLAN. Yes, there is a budget for Cidofovir in that.
Senator HARKIN. In the stockpile?
Dr. KOPLAN. Yes.
Senator HARKIN. Secondly, Senator Specter apologized; he had to
leave to go to the Judiciary Committee. Both of us were discussing
here the figures, Dr. Koplan, that you went over with him. There
is just a little bit of confusion here on the smallpox development
versus the smallpox vaccine, and we are trying to get a handle on
that.
Without going into it because we want to move to our next panel,
could you just submit to us again the details of what you just dis-
cussed with Senator Specter?
Dr. KOPLAN. Can I do that for the record?
Senator HARKIN. You want to do that now or do you want to sub-
mit it for the record?
Dr. KOPLAN. Can I submit it for the record?
Senator HARKIN. Please submit it for the record.
Dr. KOPLAN. Okay.
228
Senator HARKIN. Well, I am told by staff that we need to get this

budget today.
Dr. KOPLAN. We will have it to you before the day is over. It is
easier to see it written out on a line, and we will have it for you
today.
Senator HARKIN. There is just a little bit of confusion on this, on
a couple of those figures.
Dr. KOPLAN. We will have it on paper before the hearing is over,
how is that?
Senator HARKIN. Rather than sitting here going back and forth,
just give it to the staff afterwards.
Dr. KOPLAN. Great.
Senator HARKIN. Also, with those figures, Senator Specter also
needed to know, just again we need to know time lineshow much
now, how much you need later on, so we know the flow of the
money.
Dr. KOPLAN. Will do.
Senator HARKIN. Lastly, do we have to provide money each year
for upgrading State and local public health? You mentioned the fig-
ure of $1.050 billion. That was for upgrading State and local capac-
ity. We are going to be hearing from some of the hospitals here on
the next panel, but obviously there is a one-time up-front cost for
training and that type of thing. But then there is going to have to
be some ongoing costs.
Dr. KOPLAN. Actually, there is very little up-front cost for train-
ing because the training is ongoing for all these individuals. Yes,
we would start right off with training, but the nature of the turn-
over in local and State health departments and the nature of new
knowledge being imparted is such that training goes on literally
365 days a year for laboratorians and epidemiologists. So that is
an ongoing thing.
Senator HARKIN. So you are looking at that $1.050 billion as
Dr. KOPLAN. This is a yearly cost to keep our local and State
health departments up to speed.
Senator HARKIN. So you are saying this committee has got to
come up with an extra billion every year?
Dr. KOPLAN. Yes.
Senator HARKIN. Okay.
Dr. KOPLAN. In my professional judgment.
Senator HARKIN. I am sorry that Mr. Stevens left before that
one. But anyway, we will make sure he hears that.
Thank you both very much again from a personal standpoint, but
also speaking for this committee, we thank you both for your great
leadership that you have shown in these trying times.
Barring any unforeseen circumstances, I doubt that we will be
having you here again before the end of the year, but certainly
when we come back in January we will want to have you back
again to see where we are at that point in time, probably at the
end of January, early February, come back and see if we need to
make any adjustments in our budgets at that time.
Dr. KOPLAN. Thank you.
Senator HARKIN. We will be having supplementals.
Dr. FAUCI. Thank you very much, Mr. Chairman.
Senator HARKIN. Thank you very much, Dr. Fauci, Dr. Koplan.
229
Next, we have a vote coming up at 10:30. I am going to try to

see if we can bring this next panel up: Dr. Ken Alibek, President
of Advanced Biosystems; Dr. Joseph Barbera, Associate Professor
and Co-Director of the Institute for Crisis, Disaster, and Risk Man-
agement at the George Washington University; and Joseph
LeValley, Senior Vice President for Planning and Systems Develop-
ment, Mercy Medical Center of Des Moines, Iowa.
We will start off in the way I have introduced: Dr. Alibek, Presi-
dent of Advanced Biosystems. Dr. Alibek, I might inform the audi-
ence, defected to the United States from the Soviet Union in 1992.
Prior to that he was the Deputy Director of Biopreparat, the civil-
ian arm of the Soviets biological weapons program. Dr. Alibek fre-
quently briefs U.S. military, intelligence, and medical officials
about biological weapons and defenses. He is the author of Bio-
hazard, which describes his experiences running the Soviet bio-
weapons program. He holds M.D., Ph.D., and Doctor of Science de-
grees which he has received in the Soviet Union.
Dr. Alibek, welcome to the committee. Your testimony will be
made part of the record and just please proceed as you desire.
STATEMENT OF KEN ALIBEK, M.D., PRESIDENT, ADVANCED BIOSYS-
TEMS, INC.
Dr. ALIBEK. Thank you. Mr. Chairman, thank you for inviting me
to speak today. I know I have not much time, but I will try just
to be absolutely short.
In my opinion, one of the biggest issues we need to resolve as
soon as possible is what kind of research do we need to do in the
field of weapons threat analysis and development of medical de-
fense against biological weapons threat agents. I know we are fo-
cusing now on anthrax and smallpox. I fully support this work and
I believe that anthrax and smallpox could be considered as an im-
minent threat to our Nation.
But at the same time, we need to keep in mind, unfortunately,
the number of biological agents that could be used in biological
weapons is very large. Just a short analysis done in the former So-
viet Union showed that several dozen different biological agents
could be used in biological weapons. Many of them have been de-
veloped in the form of biological weapons. For example, just a short
enumeration probably would show you what is the real biological
weapons threat.
In addition to anthrax, bacterial agents like plague, tularemia,
brucellosis, glanders, melioidosis have been developed as biological
weapons. Viral biological agents include smallpox, Ebola, Marburg,
various encephalitis, and some other viral hemorrhagic fevers.
There is a group of biological weapons based on so-called rickettsial
agents: epidemic typhus, and so on and so forth. There is a group
of so-called fungi biological weapons, including blastomycosis and
toxidiumicosis.
Of course, I realize that if we start taking care of all these agents
probably it would not be possible to find such a huge amount of
money. But at the same time, we need to start doing some work
to understand what is the real biological weapons threat. In my
opinion, we need to rectify our knowledge, our understanding of the
biological weapons threat. It would help us to develop a new con-
230
cept of biological weapons defense. When we work in the field of

biological weapons defense or medical defense against biological
weapons, we usually work in three major fields.
One field is so-called prophylaxis, or vaccine development; an-
other field, so-called emergency prophylaxis is when we develop
some medical means and approaches just to use for pre-exposure
or post-exposure prophylaxis. I mean immediate pre-exposure, post-
exposure. Then there is a third field, so-called treatment.
But when we discuss this issue, we focus very much on vaccines.
I have nothing against vaccines, but what we need to keep in mind
is that vaccines have been considered as the best defense against
biological weapons by many countries to protect troops. Nobody
considered vaccines for use in protecting civilian populations, be-
cause of some important reasons.
What we need to keep in mind is that vaccines usually take
weeks and months just to take effect. In this case, for example, the
just recent anthrax event, nobody discussed the necessity of using
anthrax vaccine to vaccinate people who got infected.
In this case, of course, we need to spend more time just to see
what kind of emergency prophylaxis means we could develop and
use to take care of these infected individuals. We need to pay much
attention to our treatment options and see what we can use to
treat these individuals.
There are many other issues, but what I would like to say, when
again we discuss the smallpox vaccineI fully support this effort.
We need to develop this vaccine because of two important reasons:
because this infection is a very threatening, contagious infection
and could cause epidemics and pandemics; but at the same time,
this infectionthis vaccine, I mean, this vaccine could be used not
just for containing outbreaks and epidemics. It could be used for
treatment, for so-called post-exposure prophylaxis. This vaccine is
the only means we have got now just to protect against smallpox.
But at the same time we need to think what else we can do, be-
cause I do not envision any situation in which we are going to vac-
cinate the entire population of the United States against anthrax,
for example, prior to any anthrax incident. I do not envision a situ-
ation in which you are going to vaccinate the entire population of
the United States against many different infections.
In this case, of course it does not mean we do not have to work
in this field of vaccines, but it means we need to focus much effort
in the field of emergency prophylaxis and treatment, because
theres not just a single way to protect, such as to develop and de-
ploy vaccines.
One more issue I would like to touch on here. You know, the So-
viet Union as a country has spent decades and decades researching
and developing new biological weapons. My knowledge is coming
from the Soviet Union, and my expertise in this field. Since I came
to the United States in 1992, I have spent years and years dis-
cussing these biological weapons threat issues and possible ap-
proaches to biological and medical defense against biological weap-
ons with many experts here in the United Statesmilitary experts,
civilian experts. We discussed the different aspects of this problem.
You know what is getting obvious? Unfortunately, we have lost
the knowledge and understanding of biological weapons threat
231
some time in the sixties and seventies. Since the seventies a lot has
changed. We need to keep in mind two important things. Now
when we discuss a biological weapon, or let me say medical defense
against biological weapons, we are working in the field of devel-
oping protection against biological weapons developed in the seven-
ties, early seventies and late seventies.
But you know, starting from the eighties a lot of new biological
weapons have been developed. A lot of new genetically engineered
agents and weapons have been developed. We are not addressing
these issues now.
There is another problem when we talk about developing protec-
tion against biological weapons. In my opinion it is a major point.
When we develop a new vaccine, it usually takes from 8 to 12 years
to develop and get a new vaccine approved. But you know, my per-
sonal experience is that the development of biological weaponsI
knew about many biological weapons developed in the former So-
viet Unionusually takes from 3 to 4 years.
You can imagine in this case it is a sort of a race, with biological
weapons appearing that are genetically engineered, antibiotic re-
sistant, new agents, and so on and so forth. If you have got this
time range for the development of protection, 8, 12 years, we will
be increasing, widening the gap between our knowledge in the field
of biological weapons defense and an actual situation in the field
of biological weapons threat agents. In my opinion, this is impor-
tant to address.
At the same time there is a group of scientists still in Russia.
Some of them from the former Soviet Union are in the United
States, in some European countries, Asian countries.
PREPARED STATEMENT
I am finalizing my talk. What we need to do in my opinion, we

need to use the knowledge of these people, because many of them
are underemployed now. Useing their tremendous knowledge in the
field of biological weapons threat and defense probably would give
us a lot of benefits here in developing a defense against biological
weapons.
PREPARED STATEMENT OF DR. KENNETH ALIBEK
TOPIC: BIOTERRORISM
Thank you, Senator Harkin and members of the Committee, for inviting me to
testify for you today on the topic of bioterrorism. I am in a rather unique position
to discuss these issues, since I developed biological weapons for the Soviet Union
for nearly twenty years, until my defection in 1992. When I left the Russian biologi-
cal warfare program, I had been serving as First Deputy Director of Biopreparat,
the civilian arm of the biological weapons program, for four years. At that time, I
was responsible for approximately 32,000 employees and 40 facilities, comprising
over half of the entire Russian programs personnel and facilities. Since arriving to
the United States, my personal and professional goal has been to make the greatest
contribution I can to the elimination of the danger of biological weapons.
Biological Weapons Threat of Proliferation and Terrorism Following the breakup
of the Soviet Union and the end of the Cold War, the threat of proliferation of mass
casualty weapons has grown dramatically. In some ways, the danger posed by the
proliferation of biological weapons and biotechnology is greater than that of nuclear
proliferation. For example, the acquisition, manufacture, deployment, and move-
ment of nuclear components or weapons is much more expensive and difficult to
achieve than that of biological agents. A freeze-dried vial of anthrax can easily be
232
obtained and concealed, and the knowledge of how to turn that vial of anthrax into
a biological weapon is in the possession of hundreds of scientists and technicians.
The recent incidents of anthrax dissemination through the Postal Service have only
served to demonstrate the reality of this threat.
The growing frustrations among scientists within the former Soviet bioweapons
community add to the risks of proliferation. Despite initiatives directed by the
United States government to employ some of these scientists and to shift the focus
of their research to peaceful projects, more needs to be done. Many of these sci-
entists are highly trained in biotechnology and their talents could be directed to-
ward finding new methods of preventing or treating the diseases caused by these
pathogens. Several former bioweapons scientists have emigrated to the West and
are currently under-employed. We fear that in order to feed their families, others
may offer their technical skills on the open market, which could provide our enemies
with technical expertise or ready-made, engineered organisms. Some Russian micro-
biologists are reportedly teaching students from rogue states that are interested in
this expertise. Other prominent scientists have simply dropped out of sight.
In a report to the Senate Permanent Subcommittee on Investigations in 1995, the
U.S. Office of Technological Assessment identified 17 nations believed to possess bio-
logical weapons. It is estimated that at least 20 countries either have active re-
search programs or were formerly involved in biological weapons research and pro-
duction. In many cases, these are nations that are also engaged in chemical and nu-
clear programs, since they feel the necessity to protect themselves from hostile
neighbors by any means necessary.
BIOLOGICAL DEFENSE AND TREATMENT OPTIONS
In the U.S. and other countries, growing fears of a biological attack by a hostile
country or a terrorist group have prompted intensive efforts in the areas of con-
sequence management, response planning, intelligence gathering, and nonprolifera-
tion of expertise. However, little effort has focused on new methods for treatment
or prophylaxis of biological threat agents.
Unfortunately, the diseases caused by many biological threat agents, such as
smallpox, Ebola, and Marburg are currently untreatable. For so-called treatable dis-
eases, such as anthrax, plague and tularemia, current methods of treatment or med-
ical prophylaxis are often ineffective. Antibiotic resistance is on the rise, and in
many cases biological threat agents have been genetically engineered to increase
their resistance to drugs.
Similarly, vaccines do not exist for the majority of biological threat agents. This
situation is unlikely to change when we consider that it takes 34 years to engineer
a new drug resistant or more virulent bioweapons, but it takes 1012 years to de-
velop and get Food and Drug Administration approval for a new vaccine. Even the
few available vaccines are often ineffective against biological weapons for three rea-
sons:
Vaccines often require weeks to months to take effect;
Vaccination of large portions of the population against numerous threat agents
in advance of a biological incident is not feasible
Biological threat agents can be engineered to circumvent the action of vaccines
NEW PARADIGM
We need to develop a broader appreciation of the scope of the threat posed by the
major biological threat agents and possible medical and public health responses to
them. This can only be achieved through extensive biomedical research aimed at de-
veloping new prophylaxis and treatment strategies.
New approaches are needed to both prevent and treat these pathogens, and our
country needs to be at the forefront of medical research aimed at studying and de-
veloping novel approaches to combat disease. Recent advances in our understanding
of the immune system are making it possible to create new tools to defeat invading
organisms by boosting the immune response. These new means and approaches
would supplement or replace drugs used to attack the invader. Tools to boost the
immune system are not limited to infectious diseases, but can also be applied to the
treatment of cancer, cardiovascular, autoimmune, and age-related diseases.
Research in this area should include investigations of the etiology and patho-
genesis of infections caused by biological weapons, specific and nonspecific
immunomodulation as a means of eliminating pathogens, and new antiviral and
antibacterial drugs. Many of the treatments that could be developed based on this
research could be useful not only for the purpose of medical defense, but also for
the greater purpose of improving the general health of mankind.
233
INTERNATIONAL COLLABORATION TO CATALYZE THE DEVELOPMENT OF EFFECTIVE
RESPONSES TO BIOTERRORISM
Countering bioterrorism will require efforts on an international scale. We should

establish and maintain international collaborations of experts on bioterrorism and
biodefense. The following research areas would greatly benefit from international
collaboration:
The potential of various biological threat agents
Possible production and deployment methods used by terrorists
Technical countermeasures to biological aerosols
Analysis of possible genetic engineering of biological threat agents
Epidemiology of infections caused by biological weapons
Disinfection of large contaminated areas and buildings
Medical microbiological, molecular biological, and immunological methods for
the development of protection against biological weapons
Research and development of novel therapeutic and prophylactic regimens for
infections caused by biological weapons
Signatures of possible production facilities
Addressing these issues will greatly enhance the international communitys pre-
paredness for a biological attack.
Senator HARKIN. Thank you, Dr. Alibek. That is a great sugges-
tion. I read it in your testimony and that needs to be followed up
on and I intend to follow up and find out what the administration
is doing on that.
Dr. Barbera, welcome to the subcommittee. Dr. Barbera, your
testimony will be made a part of the record in its entirety and I
will ask you to summarize it if you could.
I just want to say again that Dr. Barbera is Associate Professor
and Co-Director of the Institute for Crisis, Disaster, and Risk Man-
agement at GW University. Dr. Barbera.
STATEMENT OF JOSEPH BARBERA, M.D., ASSOCIATE PROFESSOR AND
CO-DIRECTOR, INSTITUTE FOR CRISIS, DISASTER, AND RISK
MANAGEMENT, THE GEORGE WASHINGTON UNIVERSITY
Dr. BARBERA. Thank you very much, Mr. Chairman. I will try to
summarize. My statement is relatively short.
I have been an operational emergency medical responder to
major disasters for the past decade for the Urban Search and Res-
cue system for the Office of Foreign Disaster Assistance. I re-
sponded to the Oklahoma City bombing and after the September
11th events. I was a responder to both the Pentagon and World
Trade Centers.
I have additionally been involved through the hospital and
through local preparedness efforts with the bioterrorism events
that occurred recently here in Washington, D.C.
I am coming at this from a different angle than what we have
heard in the prior testimony and that is from the operational med-
ical perspective: how do we actually address bioterrorism and other
types of mass casualty terrorism at the operational level, how do
we institute medical care, how do we apply the principles, the sci-
entific principles that you have heard talked about earlier?
I would like to say also that I think it is important that at this
point we start to focus very much on hospital preparedness for
mass casualties. This has not been something we have done in the
past. It is something the public and the press have asked about:
Why do we not have adequate preparedness at the hospital level
for mass casualties?
234
What we have right now is hospitals trying to do reasonable pre-

paredness for mass casualty events, and it is my belief that there
is a wide gap between what is adequate and what is reasonable.
The current medical economics are such that hospitals have very
little left over to spend on things that do not have to do with the
everyday practice of medicine. When I have talked to hospital ad-
ministrators in the past about disaster preparedness, many of them
have responded that their main concern is not the terrorism that
could occur 3 months from now, it is whether or not their hospital
will be in business 3 months from now due to medical economic
constraints.
It is important to recognize that preparedness for mass casualty
terrorism and mass casualty events from a hospital perspective has
very little to do with what hospitals do on an everyday basis and
what they do to prepare for the old-fashioned definition of a dis-
aster, which is 1 to 10 or 20 casualties from a trauma event. In
order to prepare for these things, I think it is time that we start
to focus on how we treat hospitals as part of the public safety func-
tion in the American emergency response community.
As I have put into my testimony, right now when you need fire
suppression you call 911 and you get fire response, which is a gov-
ernment entity. When you need law enforcement, you get police
and that is a government entity. When you need mass casualty
medical care, you get 911 and you get EMS, which is a government
entity. But the patients end up at hospital facilities that are gen-
erally private, for-profit, not-for-profit, even public hospitals, that
do not have a budget for mass casualty preparedness.
If we are going to adequately prepare for this, we need to pay
attention to that, start to treat at a public policy level mass cas-
ualty medical care as a public safety function. We also have to rec-
ognize that hospitals are very much a vital asset in community
emergency response and they deserve the same level of security
and other attention that other government emergency response en-
tities are given.
So how do we address this? I think you are taking a very impor-
tant step here and I congratulate you on focusing on hospital pre-
paredness for mass casualties. I think there are models out there
for public-private emergency response partnerships that can be fol-
lowed and I have referenced a paper that I did for the Harvard
Kennedy School that addressed this specific subject.
I think that hospitals very much would be willing to develop
even a contractual relationship with local community emergency
response, to develop programs that include training and mainte-
nance of those programs for mass casualty care and for specialty
care, for true surge capacity for not just bioterrorism events, but
an all-hazards mass casualty preparedness.
In closing, I would like to say very much that I think that we
have a very strong medical foundation here at the hospital and the
acute care medical communities across the United States. I have
been part of the bioterrorism response entity here in Washington,
D.C., over the past month and a half. I chair the D.C. Hospital As-
sociation Emergency Preparedness Committee. We have developed
a mutual aid memorandum and a hospital mutual aid system in
235
Washington, D.C., between all of the hospitals in Washington,

D.C., and including the four Federal hospitals in the D.C. area.
As part of our response, we established a daily conference call
that ended up encompassing most of the hospitals in the National
Capitol Region, most of the public health authorities in the area,
and the acute care medical community. As the moderator of those
conference calls, I was quite encouraged and inspired at how hos-
pitals came together and worked very hard for community better-
ment during this.
PREPARED STATEMENT
I think that we have a possibility now or a very strong prob-

ability to develop programs that promote operational medical sys-
tems, not just the buying of equipment, not just seed money that
will start programs that will then be another unfunded Federal
mandate for hospitals to continue, but an opportunity to develop
operational systems of information management, communication,
true collaboration between the acute care medicine and public
health entities, things that will be ongoing that will improve the
medical care in the United States, not just for terrorism response
but for all-hazards mass casualty events.
PREPARED STATEMENT OF DR. JOSEPH A. BARBERA
Mr. Chairman and Members of the Subcommittee, I am Joseph A. Barbera, a resi-
dency trained, board certified emergency physician. I am Co-Director of the Institute
for Crisis, Disaster, and Risk Management at the George Washington University,
where I teach masters and doctoral emergency management courses, and I provide
emergency medicine services through the George Washington University Hospital.
One of my professional volunteer activities is chair of the Emergency Preparedness
Committee of the District of Columbia Hospital Association (DCHA), a position I
have held since the committees inception in 1995. In this role, I have presided over
the development and implementation of a comprehensive Hospital Mutual Aid Sys-
tem that provides effective coordination and communication between the Districts
hospitals in emergency preparedness and response. The four Federal hospitals in
the National Capital Region, Walter Reed, National Naval, Malcom Grow, and the
Veterans Administration Medical Center are all very active and vital participants
in this process.
During my medical career, I have also had the privilege of experiencing disaster
response to major incidents. I have participated in the FEMA and Office of Foreign
Disaster Assistance Urban Search & Rescue programs for over a decade, including
earthquake responses to Northridge California, Taiwan in 1999 and the Philippines
in 1990. I have responded to major terrorism incidents, providing medical expertise
to the search and rescue effort after the Oklahoma City bombing and, after Sep-
tember 11, to both the Pentagon and the World Trade Center incidents.
I have additionally experienced the specter of biological terrorism. I was the emer-
gency physician on duty at George Washington University Hospital the day of the
Bnai Brith bioterrorism hoax in 1997. I was a medical controller for the TOPOFF
bioterrorism exercise in Denver in 2000. Most recently, I was heavily involved in
the recent anthrax dissemination incident here in the National Capitol Region. In
my role for DC Hospital Association, I established a daily conference call that be-
came the basis for information exchange between hospitals, acute care providers,
and the multiple public health authorities in the National Capitol Region. We are
currently developing a profession review of that incident response to capture the
views of the hospital-based medical community.
I have been asked to speak to you today about the subject of hospital prepared-
ness for mass casualty response. I would like to note that I provide this testimony
from the medical perspective of a hospital-based emergency physician with extensive
experience in emergency public health and emergency response. I have no remu-
nerative relationship representing hospitals, or hospital associations, in this regard.
236
I would like to begin by congratulating and thanking you for focusing on this vi-
tally important subject. As we face the specter of mass casualties from chemical, bio-
logical, incendiary or explosive attacks, the press and the public are continuously
asking why the medical care community is not adequately prepared for these possi-
bilities. Many vague reasons have been put forth, but the cold hard reality is that
adequate preparedness is impossible without basic changes in public policy attitudes
towards funding medical preparedness.
First, one must understand that the non-governmental medical system must be
viewed as a first responder in mass casualty care.
Next, one must understand what mass casualty care entails. The medical infra-
structure needed to care for one or ten injured or ill individuals is completely dif-
ferent from that required to care for hundreds or thousands of patients. The infra-
structure for mass casualty care also has very little to do with everyday hospital
practice. This is not a minor technicality to be recognized and understood only by
medical planners. This is a fundamental financial reality that must be addressed
by the highest level of political leadership at all levels of government. It is also criti-
cally important to understand the following key concepts:
When you need firemen for fire suppression, you call 911 and the municipal fire
department responds with the needed assets. All non-governmental assets are
bit players. We stopped expecting private fire insurance companies to fund mu-
nicipal fire services somewhere around two hundred years ago.
When you need law enforcement to control a situation, you call 911. Police re-
spond and become the primary force that provides law enforcement. Private se-
curity is only a bit player if involved at all.
When you need acute medical care for hundreds or thousands of casualties, you
call 911, but the response capabilities are completely different. Municipal serv-
ices have little significant acute medical care capacity beyond triage and trans-
port of patients. Definitive medical care in Washington DC, and most areas of
the United States, is a function of primarily private sector assets. As such, all
hospitals should be viewed as critical emergency response assets within a com-
munity, and accorded security considerations similar to that provided to govern-
mental emergency response entities.
The next reality is that private medicine has been shaped by medical economic
forces beyond the control of the medical and hospital community. Hospitals now sur-
vive by adopting modern business practices such as just-in-time inventory, bare
minimum staffing patterns, closure of empty hospital beds. All these make smart
business sense, but they have severely impacted health care surge capacity for both
mass care and for specialty care of unusual victims such as critical care patients,
ventilator patients, burn patients, patients requiring isolation, and so on. In an era
of barely survivable medical economics, the government and the public have ex-
pected private medicine to pay on its own to cover the exorbitant costs of the com-
munitys mass casualty preparedness. It hasnt happened, which is why we are here
today.
Mass casualty medical care must be recognized as a public safety function, and
therefore as a governmental responsibility equal in importance to fire suppression,
emergency medical services, public works, and law enforcement. Until public policy
changes to address this financial reality, we have little chance of adequate prepared-
ness for mass casualties. Hospitals, in their current financial circumstances, can at
best make a good-faith effort at reasonable preparedness, and indeed they are doing
so. The difference between adequate and reasonable is wide, and I believe it is unac-
ceptable to the American public.
How can we address this gap?
Begin with a fundamental change in governmental attitudes towards hospitals,
and I commend you for taking this important step. Government must actively solicit
the hospitals planning input through hospital group efforts such as the DC Hospital
Associations Emergency Preparedness Committee. Government agencies must un-
derstand that they have an obligation to support hospitals in planning for mass cas-
ualtiesHospitals are in fact in the drivers seat of providing medical care. Govern-
ment, including government public health entities, must allow hospitals to have sig-
nificant input in developing the most effective ways for them to organize and to be
assisted by governmental assets in preparing for and responding to mass casualty
events.
A major fact of emergency management is that the planning process is far more
important than any actual plan. The process must promote the development of effec-
tive planning and response relationships between key players, and this is even more
important in areas such as healthcare, where many of the key resources are non-
governmental. It again is a governmental obligation to assure that this objective is
accomplished, and I believe this should be a goal of your legislative efforts.
237
Finally, government at all levels must accept that mass and specialty casualty
care is a public safety function and must have adequate funding provided to hos-
pitals who are willing to accept the responsibility for this community need. Hos-
pitals do not need, nor should they accept, seed money that begins expensive
emergency preparedness programs that result in additional unfunded Federal man-
dates. Hospitals need to become funded partners in community emergency prepared-
ness, fully integrated into emergency response. Hospital mutual aid systems, effec-
tive collaboration between public health and the hospital community, mass decon-
tamination capabilities, critical care surge capacity, improved information systems
for communicating between hospitals and with key health officials are only a few
of the requirements that would provide immense public benefit. Public hospitals, in-
cluding our Federal hospital partners here in the Washington DC area, must receive
the same financial attention.
Many hospitals, I believe, would be very willing to agree to a contractual relation-
ship with the local community that adequately funds development, training, and
maintenance of defined surge capacity and other specialized resources. Medical re-
alities, such as the twenty- percent annual turnover in emergency department staff
found in many hospitals, must be addressed in the training aspect of system mainte-
nance. Many models exist for this type of public-private emergency response part-
nership, and have been described more fully in an article I co-authored for the Ken-
nedy School of Government at Harvard University, titled Ambulances to Nowhere:
Americas Critical Shortfall in Medical Preparedness for Catastrophic Terrorism.
In closing, I would like to emphatically state that this is not a time for political
maneuvering, and it is not a time for shaping public perceptions of medical response
competence through any route other than actually becoming competent in a plan-
ning process that could mean life or death for future terrorism victims in the United
States. The coming together and voluntary commitment to community well-being
that I witnessed by hospitals in the National Capital Region since September 11
have been both encouraging and inspiring. We have a very strong medical founda-
tion upon which to expand our mass casualty preparedness. I urge you to thought-
fully develop a program that promotes creation of operational medical response sys-
tems that are effective, sustainable, and multi-use.
Mr. Chairman, that concludes my prepared remarks. I apologize that they are not
more detailed, but I was invited to furnish this testimony only two days ago, and
my schedule did not provide the amount of time I would have liked to further shape
my comments. I would be pleased to answer any questions you or members of the
Subcommittee may have at this time.
Senator HARKIN. Thank you very much, Dr. Barbera.
There is a vote on now. I think what I will do is I will hear Dr.
LeValleys testimony, then we will take a break. You might get to-
gether with Dr. Koplan so he can get back and get these figures.
Then I will come back here for a round of questioning. Senator
Specter may come back with me at that time also.
So now we will turn to Dr. Joe LeValley, Senior Vice President
for Planning and Systems Development, Mercy Medical Center in
Des Moines, Iowa, again, hearing from people out in the field as
to, again taking off from what you just talked about, Dr. Barbera,
what we need in our local hospitals to be ready for any contingency
like this. I am going to get into that more later when I get back
to my questions.
Dr. LeValley, welcome again to the committee.
STATEMENT OF JOSEPH LeVALLEY, SENIOR VICE PRESIDENT FOR
PLANNING AND SYSTEMS DEVELOPMENT, MERCY MEDICAL CEN-
TER OF DES MOINES, DES MOINES, IOWA
Mr. LEVALLEY. Thank you, Mr. Chairman. My name is Joe
LeValley. I serve as Senior Vice President for Planning and System
Development at Mercy Medical Center in Des Moines.
I want to begin by saying it is an honor for me to be here rep-
resenting our hospital and indirectly thousands of other hospitals.
Mr. Chairman, as an Iowan it is particularly a pleasure to appear
here before this committee. I and everyone at Mercy have enjoyed
238
the opportunity to work closely with you and your staff for many
years and appreciate your longstanding support of health care in
Iowa.
Mercy is a 691-bed tertiary hospital. We are involved in pro-
viding care in more than 50 sites, including physician clinics, nurs-
ing homes, hospice, and a dozen rural community hospitals. So I
am going to try to bring the perspective as a non-clinician, the per-
spective of an administrator trying to coordinate with many others
the care of Iowans in these issues.
One of the questions that Americas hospitals have been asking
since the national tragedy of September 11 is how ready are we to
respond to incidents of terrorism involving biological, chemical, or
nuclear materials. One answer is that we currently are well pre-
pared to decontaminate, triage, diagnose, and treat a small number
of victims of exposure to these dangerous materials. Our medical
center, as an example, has one portable decontamination unit that
can be utilized. We have one negative air flow room in our emer-
gency department that prevents fumes and particulates from enter-
ing the rest of the hospital. We have a large emergency department
with 38 exam and treatment rooms and a staff of more than 120
people. This emergency department cares for 56,000 people a year,
the most of any in Iowa.
One reason we can claim to be ready for modest incidents is that
we recognized even before September 11th the need to do more and
we have implemented last spring an aggressive program to in-
crease our preparedness. It involved training, new equipment, new
haz-mat suits, new policies and procedures, clinical guidelines, se-
curity measures, several education programs, etcetera.
We also participate in the Metropolitan Medical Response Sys-
tem, which is a community-wide effort we are very proud of, that
coordinates the planning for and response to these types of things.
We have five departments represented on different committees of
that collaborative effort.
Of course, Senator Harkin, we also hosted the community forum
that you sponsored and facilitated, which was attended by people
from throughout the community and the area in addition to the
general public.
Despite our obvious pride in Mercys capabilities and prepara-
tions, I do have to report that I do not believe we are prepared, nor
any hospital is prepared, for mass casualties in the area of biologi-
cal, nuclear, or chemical exposure. When you ask, well, how pre-
pared are we, what is our level of preparedness overall, it is dif-
ficult to answer. It depends on what scale of preparedness do we
want to be ready for, what scale of attack do we think is possible.
But, having said that, that it is almost an unanswerable ques-
tion, there is no question that hospitals need to do more. An orga-
nization like ours, the largest trauma center in the State, needs
more than one portable decontamination booth. If an attack were
to occur, that booth takes care of one person every 8 minutes. That
may not be adequate, probably would not be adequate in a mass
exposure situation.
Many hospitals do not have even the basic level of the capability
that Mercy has. So we know hospitals do need to do more and we
are going to need the Federal Governments assistance to do that.
239
Some of this is occurring. We are pleased that the Des Moines

area with this collaborative team has received a $400,000 Federal
grant to get it started. But it is not nearly enough when you con-
sider the number of providers and agencies who need that money
in order to improve their capabilities.
So it is imperative the Federal Government provide additional
assistance to Americas hospitals, many of which already are suf-
fering from declining reimbursement, increasing demands for care,
and rising costs. Many of us have reached those capacity limits of
having full beds and long waiting times in our emergency depart-
ments.
This problem is especially acute in Iowa, and the Senator is very
aware of this issue, where we are severely underpaid by Medicare
in a very unfair way. That constrains all types of issues for us: our
ability to recruit and retain staff, to have adequate facilities,
etcetera.
So I have included in my testimony a kind of a laundry list of
things I think hospitals need. For times sake, I will not repeat it
here, but I think these are all critical things, not only the ongoing
education and training that Dr. Koplan mentioned, but there are
facility needs, there are equipment needs, that we have to address.
I would ask the Federal Government to address these things in
two forms: an ongoing provision of fair and adequate payment and
in specific grants to health care organizations and coalitions. Some
of the bills that are being worked on include especially the second
half of that and we appreciate that.
PREPARED STATEMENT
In closing, I want to say thank you. We appreciate Senator Har-

kins and the committees attention to this critical issue, and we
certainly appreciate any support you are able to provide Americas
hospitals in dealing with these threats.
PREPARED STATEMENT OF MR. JOSEPH LEVALLEY
Mr. Chairman and members of the Committee, my name is Joe LeValley and I
serve as Senior Vice President for Planning and System Development at Mercy
Medical Center in Des Moines, Iowa. I want to begin by saying that it is an honor
for me to be here today, representing our hospital and, indirectly, thousands of other
hospitals across our nation. Mr. Chairman, as an Iowan, its a particular pleasure
to appear before this committee. I and everyone at Mercy have enjoyed the oppor-
tunity to work closely with you for many years, and appreciate your longstanding
support of health care providers in Iowa, and of the patients and families we serve.
Mercy Medical Center is a 691-bed tertiary medical center in downtown Des
Moines. However, our organization is involved in providing care in more than 50
sites including physician clinics, nursing homes, hospice and a dozen rural commu-
nity hospitals in central and southern Iowa. We are members of Catholic Health Ini-
tiatives, one of the nations largest not-for-profit health care systems, and are affili-
ated with Mercy Health Network, a statewide network of hospitals and clinics in
Iowa.
I have worked for Mercy hospitals in Iowa for 18 years. In my current role I am
responsible for the strategic and facilities planning for Mercy-Des Moines and I
oversee our Network of community hospitals. In contrast to several of the other wit-
nesses, I am not a clinician. The perspective I hope to provide to the committee is
that of an administrator who works closely with physicians, nurses and managers
in all areas of the organization to try to ensure that our programs, services and fa-
cilities are adequate to meet the needs of more than 650,000 people living in the
nine counties of central Iowa.
240
One of the questions that Americas hospitals have been asking since the national
tragedy of September 11, is: how ready are we to respond to incidents of terrorism
involving biological, chemical or nuclear materials? One answer is that we currently
are well prepared to decontaminate, triage, diagnose and treat a small number of
victims of exposure to these dangerous materials. Our medical center has one port-
able decontamination unit that can be utilized in the Emergency Department garage
with just 12 minutes notice, and we have one negative air flow room that prevents
fumes or particulates from entering the rest of the hospital when caring for cases
such as these. We have a large Emergency Department, with 38 exam and treat-
ment rooms and a staff of more than 120 nurses, doctors and support staff. This
ED receives and cares for 56,000 patients a yearthe most of any hospital in Iowa.
One reason Mercy-Des Moines can claim to be ready for modest incidents is that
we recognized, even before September 11, that we and the rest of the community
needed to do more to prepare for the possibility of mass exposure to biological,
chemical or nuclear agents. As a result, Mercys clinical and safety leaders began
an aggressive program to increase our preparedness. Since last Spring Mercy has
provided hazardous materials training to all members of the staff of the Emergency
Department. This training has totaled more than 600 person-hours. In addition, we
have added new equipment, such as the decontamination booth, and about a dozen
special Haz-mat suits to protect staff as they decontaminate and care for these pa-
tients. We have developed new policies and procedures, we have developed clinical
guidelines for dealing with specific agents, such as Anthrax, we have stepped up our
disaster drills, and we have increased our security measures for the hospital and
its ambulances and helicopter. We also have hosted several educational programs
for health care providers, have been active participants in the Metro Medical Re-
sponse Systema community-wide effort to coordinate planning for, and response
to, disasters such as were discussing today. Mercy currently has representatives
from Emergency Services, Infection Control, Safety and Security, Laboratory and
Pharmacy serving on committees for this effort. In addition, Mercy representatives
participate in the Iowa Department of Public Healths Disaster Preparedness Initia-
tivea statewide effort to create teams to respond to terrorist incidents. Lastly, as
you know, Senator Harkin, Mercy hosted a community forum in October which you
organized and facilitated, that was attended by emergency personnel from every
agency and organization, in addition to the general public.
Despite our obvious pride in Mercys capabilities, and the leadership we have
shown in this important arena, I must report to the committee that we are NOT
preparednor do I believe any hospital in America is preparedfor large scale dis-
asters involving biological, chemical or nuclear agents. What is our level of pre-
paredness overall? That is a difficult question to answer specifically, without defin-
ing the magnitude of the threat for which we want to be prepared. But I DO believe
a large trauma center such as Mercy needs more than one decontamination room
and one negative-air-flow treatment room. I know that the many hospitals that do
not have even that basic level of capability must address this deficiency as well.
There may be no upper limit to the resources that could be committed to increasing
the health care systems preparedness. However, I believe the federal government
does need to commit additional funds to assist hospitals in doing more.
Some of this is being done. For example, the Metro Medical Response System in
Des Moines has received a $400,000 federal grant to improve the surveillance, com-
munications, response and treatment capabilities related to potential terrorist acts.
The Des Moines emergency workers and health care providers very much appreciate
this support. However, it is not nearly enough, when you consider the multiple po-
lice departments, fire departments, hospitals, first responders and other agencies
and organizations that are attempting to improve their capabilities.
It is imperative that the federal government provide additional assistance to
Americas hospitals, many of which already are suffering from declining reimburse-
ments, increased demands for care, and rising costs of wages, supplies and pharma-
ceuticals. This is especially critical in Iowa, which is one of the lowest paid states
in the nation by Medicare, and which cares for one of the highest percentages of
Medicare recipients. The latest data available shows that the average hospital in
Iowa has a negative Medicare margin of 6.5 percent. This enormous challenge is
being exacerbated by plans to reduce outpatient payments to hospitals, and to re-
duce physician reimbursement by more than 5 percent.
I respectfully submit that health care providersand hospitals specificallyneed
additional federal money to assist with the following critical needs related to our
disaster preparedness:
Community education
Clinical training
Development of clinical protocols and responses
241
Development and coordination of community disaster response plans
Improved communication systems
Improved disease surveillance and reporting systems
Purchase of decontamination and protective equipment
Improvement of decontamination and treatment facilities
Pharmaceuticals and medical supplies
Mental health resources
This federal support should come in two forms. First and foremost, the ongoing
provision of fair and adequate payment for the services provided by hospitals and
doctors. Secondly, grants to specific health care organizations, to coalitions of pro-
viders, and to governmental entities to support needed improvements.
Related to these needs in Iowa, Governor Tom Vilsack has submitted, on behalf
of the Iowa Department of Public Health, a request for a Medical/Disaster Grant.
This grant would be used equipment, vaccines, transportation support, communica-
tions improvements and many other areas related to potential terrorist events. A
portion of this money would flow to hospitals, to assist them in their roles.
Also, as you may be aware, the American Hospital Association also has done some
analysis related to these issues. The AHAs work is related more specifically to the
needs of Americas hospitals. Again, for the record, I have attached the AHAs report
entitled Hospital Resources for Disaster Readiness to my printed statement.
In closing, on behalf of Mercy Medical Center, I want to say that we appreciate
Senator Harkins and the Committees attention to the critical issue, and any sup-
port you provide to us in meeting these crucial needs. Thank you very much for the
opportunity to testify. I would be happy to answer questions.
HOSPITAL RESOURCES FOR DISASTER READINESS
The American Hospital Association has developed the following overview of the
needs of the nations hospitals related to future mass casualty events. Many experts
agree that it is a matter of when and not if such an event will occur. Without
warning, hospitals in New York, Washington DC, Pennsylvania, Virginia, Maryland,
New Jersey, and Connecticut were prepared to answer the call when it came on the
morning of September 11th. Americas hospitals will be there to do so again. The
September 11th attacks, unfortunately, resulted in high mortality and few sur-
vivors. Hospitals were ready to respond but few patients appeared. The more recent
spate of anthrax cases in Florida, New York, New Jersey and Washington, DC has
been a further test of hospitals readiness to address the increasing possibility of fu-
ture mass casualty incidents.
However, the stakes have clearly been raised since the September 11th attack.
Hospitals need to upgrade their capabilities. In a nuclear, biological, or chemical
(NBC) attack, hospitals would be severely challenged without access to additional
resources. The recent anthrax scare has shown that hospitals can adequately re-
spond to an attack yielding a small numbers of patients, but questions remain about
their readiness to deal with larger scale attacks.
This paper will provide a rough estimate of what each of the nations 4,900 acute
care hospitals would require to increase their ability to respond to a NBC attack.
We will distinguish between readiness resources required for the nations approxi-
mately 2,700 metropolitan hospitals and 2,200 non-metropolitan hospitals. For met-
ropolitan hospitals, we estimate the average number of total full-time equivalent
(FTE) employees per hospital at 1,200, with 370 clinical staff. For a non-metropoli-
tan hospital, we estimate the average number of total FTE employees per hospital
at 300, with 90 clinical staff. The source of these hospital statistics is the AHAs
Hospital Statistics database.
The resource estimates below are based on a scenario that includes an event with
casualties of 1,000 individuals seeking care at a metropolitan hospital and 200 indi-
viduals seeking care at a non-metropolitan hospital. We estimate what these hos-
pitals would need in order to sustain these intense demands for approximately 24
to 48 hours. After this period of time, we assume that the Centers for Disease Con-
trol and Prevention (CDC) Bioterrorism Preparedness and Response program, espe-
cially its National Pharmaceutical Stockpile program, would be mobilized, and pro-
vide additional medical supplies to the impacted community. It should be noted,
however, that this program is not fully implemented and concerns about its weak-
nesses have been raised (See, Combating Terrorism: Accountability Over Medical
Supplies Needs Further Improvement, GAOO1666T).
The AHA is also exploring a number of other options related to readiness, includ-
ing the need for regional coordination of community-wide efforts to deal with an in-
cident of biological or chemical terrorism; the need for educational efforts by Fed-
eral, State and local government to help hospitals and other members of the
242
healthcare infrastructure best utilize the resources outlined below; and the need to
address changes in certain regulations, such as the Health Insurance Portability
and Accountability Act (HIPAA), the Emergency Medical Treatment and Active
Labor Act (EMTALA), and other requirements on hospitals that may actually im-
pede our ability to prepare for and ultimately respond to acts of terrorism. Further,
because health care workers in hospitals would be first responders in an outbreak
resulting from biological terrorism, they may face a higher risk of infection than the
general population. Therefore, the AHA, in consultation with public health authori-
ties, will be addressing whether health care workers should be given priority with
regard to inoculation against certain biological agents (such as smallpox and an-
thrax) that are considered to be potential terrorist threats. These issues will become
agenda items for our readiness efforts.
In this document, we have included only those items that would be essential for
the shortterm (24 to 48 hours) disaster response. However, we believe that what is
ultimately needed, in both the short and long-term, is an operationally effective re-
sponse system and the integration of hospitals into the community-wide response
for mass casualty events. Because mass casualty events will, by definition, over-
whelm the resources of a single hospital, they should be seen as community-wide
concerns likely to require a broad array of community resources to supplement the
health care system. Therefore, a communitywide perspective and community-wide
planning is essential for readiness. Local government must be involved in such plan-
ning, including the public health department, police and fire department. Other
community resources are likely to be called upon and should be included in commu-
nity-wide planning, including public transportation officials, news media, telephone
and communication systems, schools, churches, voluntary disaster relief organiza-
tions, restaurants and food suppliers.
In order to ensure the readiness of the nations hospitals for such events, this
paper will attempt to provide a credible roadmap toward that goal. Operationally
effective response systems must be defined and developed so as to be sustainable
over time. All related training also must be sustained over time.
The following key areas must be addressed to increase hospital readiness:
Communication and notification
Disease surveillance, disease reporting and laboratory identification
Personal protective equipment
Facility
Dedicated decontamination facilities
Medical/surgical and pharmaceutical supplies
Training and drills
Mental health resources
Communication and notification
Mass casualty incidents create a demand for public information and multiple
means for communication with community first responder organizations. In most
cases, at least some of the information will not be readily available while the inci-
dent develops. In our mass media and multi-media culture, every news and informa-
tion source will seek access to the latest and most up-to-date information. Absent
clear and credible information, speculation may reign, and increase the stress and
pressure of the incident, especially on the hospital and its staff. Therefore, planned
and structured arrangements for communication throughout the incident and during
its response are critical components of hospital and community preparedness. For
example, all organizations involved in the community preparedness plan for mass
casualties, including hospitals, need to agree in advance on who will serve as the
single, regional spokesperson. If a government official is designated as the spokes-
person, health experts must be provided to assist the official with responses to med-
ical questions. To minimize disruption of hospital patient care activities, press
events should be conducted away from health care facilities, using regularly sched-
uled and pre-announced media briefing times.
Further, in a mass casualty incident, it is critical that hospitals have an ongoing,
open channel of communications with the public safety community who may have
first awareness of the incident. A community-wide network using the same channel
is necessary. The network should be tested daily, with the test rotating across the
various hospital and emergency medical services (EMS) shifts. Members of the pub-
lic safety community, such as fire, EMS, public health departments, State, local and
Federal law enforcement, and hospitals, normally rely on effective communications
to provide emergency medical care, rescue accident victims, respond to natural dis-
asters and investigate crime. One of the lessons learned from the experiences in
the recent New York City attack, at Columbine High School in Colorado and in re-
sponse to the Oklahoma City bombing is the need for greater coordination of public
243
safety communications. These types of communications may become even more crit-
ical in the case of an NBC attack.
One of the key issues regarding public safety communications is interoperability.
Interoperability refers to the ability of different public safety entities to commu-
nicate with each other, on demand, in real time. Common problems experienced by
the public safety community include the failure of equipment in dead spots, inter-
ference, insufficient equipment, outdated equipment and channel congestion. An
array of technologies including pagers, cellular phones, mobile data terminals and
mobile laptop computers are currently used. However, a recent report suggests that
existing local land mobile radio systems are, on average, nearly 10 years old, with
State agencies having considerably older infrastructures (See, Public Safety Wire-
less Network Program Analysis of Fire and EMS Communications Interoperability,
April 1999).
Most public safety organizations, including hospitals, have experienced problems
with interoperability. There is a critical need for funding to upgrade and modernize
public safety communications systems and to address interoperability problems. In
addition, public safety communications face a variety of issues related to spectrum.
These are serious interoperability problems that arise from the fragmentation of
public safety spectrum. The most effective way to better ensure interoperability is
to incorporate the fundamental principles of the Incident Command System into
each level of emergency preparedness planning. Additional spectrum may be re-
quired, as well as improved planning and management of the interoperability spec-
trum.
In case existing systems fail in an emergency, alternative and redundant commu-
nications systems (e.g., cell phone, two-way radio, ham radio, unlisted numbers,
web-based, video conferencing, and use of human couriers) will be required as back-
up. Loudspeakers or bullhorns for communicating with the public outside the facility
may also be required for the purposes of crowd control. Finally, translators and
translated patient resource documents for non-English speaking patients will also
be needed, as well as clear signage plans for directing patients to appropriate loca-
tions within the facility.
The following are resources needed for increasing preparedness and developing an
adequate communications system for metropolitan and non-metropolitan hospitals.
Coordination of public safety communications (fire, EMS, public health depart-
ment, other hospitals, Federal Bureau of Investigation, Office of Emergency
Preparedness, etc.)
Alternative communications system if hospital communications fail/overload
(e.g., cell phone, two-way radio, ham radio, unlisted numbers, web-based, video
conferencing, courier system)
Translators for non-English speaking patients and translated patient resource
documents
Loudspeakers/bullhoms for communicating with individuals outside the facility
Signage for communicating instructions to patients and for designating various
emergency functional areas
All hospitals in cat-

Per hospital egory
Metropolitan hospitals ....................................................................................................... $75,000 $202,500,000

Non-metropolitan hospitals: .............................................................................................. 37,500 82,500,000
Disease surveillance, disease reporting and laboratory identification

A terrorist attack involving nuclear, biological or chemical agents could occur in
an overt or covert manner. Most typical of terrorist actions to date is that of a sud-
den and highly localized event producing immediate casualties, such as an explo-
sion. This is also the most likely scenario for an attack involving chemical weapons.
Scenarios involving the deployment of a biological agent are expected to occur cov-
ertly, with increasing numbers of patients presenting to hospitals and physicians of-
fices over the course of hours to weeks with signs and symptoms that may be com-
mon to many diseases and conditions. Radiologic agents could be released in either
a covert or overt manner.
Improving hospital disease surveillance and disease reporting, and the public
health infrastructure will be critical to determining that a cluster of disease may
be related to the intentional release of a biological or chemical agent. Particularly
for biological agents, an effective medical response will be critically dependent upon
the ability of individual clinicians, who may be widely scattered around a large met-
244
ropolitan area, to identify, accurately diagnose, and effectively treat an uncommon
disease. To facilitate this level of readiness, laboratory diagnostic capability will
need to be upgraded and laboratory personnel will require additional training.
The rapid identification of the chemical, biological or radiologic agents involved
in any such incident is vital to the protection of the first responders and emergency
medical personnel at local hospitals, as well as to the most effective treatment of
resulting casualties. Further, readiness will require a special ability to track large
numbers of patients and handle and display comprehensive amounts of real-time pa-
tient information, with the ability to integrate with systems currently used by Fed-
eral, State, regional and local agencies.
What follows are some of the improvements, equipment and tests that will be crit-
ical to ramping up hospital disease reporting, disease surveillance and laboratory
identification capacity.
Improvement of hospital disease surveillance, disease reporting, and public
health infrastructure
System to facilitate expedited disease reporting, dissemination of real-time
treatment guidelines and access to experts
Informatics
Patient tracking system
Detection instruments/monitors for detecting radiation
Tests/assays for detection of chemical agents and toxic industrial materials
Serologic/immunologic/nucleic acid tests for identification of biologic agents

Per hospital egory
Metropolitan hospitals ....................................................................................................... $750,000 $2,025,000,000

Non-metropolitan hospitals ............................................................................................... 375,000 825,000,000
Personal protective equipment

Personal protective equipment (PPE) refers to clothing and respiratory apparatus
designed to shield an individual from chemical, biological or other physical hazards.
The universal precautions (gloves, gown, mask, goggles, etc.) used by medical per-
sonnel to prevent infections will generally provide protection from the biological
agents commonly considered to be threats. However, in the event of a large-scale
biological event, hospitals would have to provide at least this level of protection to
all staff. A hospitals daily inventory of such items would be quickly exhausted and
the replacement of these supplies and equipment would be necessary. This is par-
ticularly the case because hospitals would have to be prepared to receive not only
patients who would be decontaminated in the field, but also patients who walk in
without being decontaminated. Initial triage must be performed by health care
workers in appropriate PPE. Today, hospitals generally are not stocked with suit-
able PPE to protect clinicians and other health care workers from exposure in the
event of a biological or chemical attack, particularly one involving an unknown
agent.
The highest level of PPE provides the utmost protection for the worker, but car-
ries the disadvantages of being extremely costly to purchase and train staff mem-
bers in its use, and is a very awkward ensemble in which to function. Other levels
may provide appropriate protection levels and yet overcome some of the disadvan-
tages. All levels of protection will fall under Occupational Health and Safety Admin-
istration (OSHA) regulations for respiratory protection (29CFR 1910.134) and per-
sonal protective equipment (29CFR 1910.132). A requirement for training hospital
employees in the use of PPE also must be included in disaster planning.
Level A protection provides the highest level of respiratory and skin protection.
The suit provides a fully enclosed environment for the health care worker, being
chemical resistant and impermeable to gases and vapors. Chemical resistant boots
and gloves also should be worn. It is used with either a self-contained breathing ap-
paratus (SCBA) internal to the suit or a supplied-air respirator. According to OSHA
this is the level of protection to be used with an unidentified agent. This level of
protection is extremely cumbersome, hot to wear and may hinder communication.
Level B protection provides slightly less skin protection than level A, in that the
suit does not provide a fully enclosed environment for the worker, but still a high
level of respiratory protection. It is also chemical resistant, but does not fully protect
against vapors, which may be harmful to the skin. Chemical resistant boots and
gloves also would be required. At this level the SCBA tank would be worn outside
of the suit, or a supplied-air respirator may also be used. Although less than level
245
A, level B protection is still cumbersome and warm, as well as limiting to commu-
nication.
Level C protection is also chemical resistant and splash proof, with chemical re-
sistant gloves and boots required. At level C, a full- or half-face air-purifying res-
pirator may be used. With this type of respiratory protection, it is essential that the
chemical agent be identified, as the cartridges must filter that specific agent. There
are some respirators available with stacked cartridges to address organic vapors and
acid gas, and to provide high efficiency particulate air (HEPA) filtration. This latter
system may prove to be effective against most agents expected to be utilized in a
situation of chemical terrorism.
Level B protection will be appropriate for front-line clinicians in most health care
applications. It provides a high level of protection, yet provides more ease of move-
ment and comfort for the health care worker, while also being less costly than level
A protection. Additionally, with SCBA or air-purifying respirators with full head
cover, immediate knowledge of the specific identity of the agent is not required. For
most agents encountered in a hospital setting, level B will be adequate, although
not the highest level of available protection. However, level C protection, with
stacked cartridges may also suffice. A health care organization must make its own
determination concerning appropriate PPE based on regulatory requirements, eval-
uation of potential hazards, and consultation with local emergency response agen-
cies. If, during the course of an incident, the contaminant is identified and deter-
mined to be a lesser threat than originally assessed, the level of personal protective
equipment can be downgraded.
For metropolitan hospitals, we assume that a basic universal precaution level
protection would be required for 1,200 FTE employees, with Level B protection
available to 50 clinicians functioning in a front-line capacitydecontamination,
triage, emergency room (ER), operating room (OR), laboratory, radiology, and custo-
dial personnelover the course of 48 hours in an event involving 1,000 patients pre-
senting to the hospital. For non-metropolitan hospitals, we assume that the basic
level of protection would be required for 300 FTE employees, with Level B protec-
tion available for 20 front line cliniciansdecontamination, triage, ER, ORover
the course of 48 hours and in an event yielding 200 patients at the hospital.
Gloves, gowns, HEPA masks (OSHA/NIOSHapproved high efficiency particu-
late), goggles, shoe coversavailable to all employees with allowances for fre-
quent glove, gown and mask changes (metro hospital $65,000, non-metro hos-
pital $16,000)
Fit-testing HEPA maskat $75 per person for all employees (metro hospital
$90,000, non-metro hospital $22,500)
Level B protection for front-line clinical staff includes:
SCBA operated in positive pressure mode
Fit-testing and maintenance requirements for SCBAs
Hooded, two-piece chemical resistant suit
Chemically resistant gloves and boots
Estimated cost of $7,000 per person; metropolitan hospital $350,000; nonmetro-
politan hospital cost of $140,000

Per hospital egory

Facility
Newly constructed and existing hospitals must comply with the Life Safety Code
(LSC) developed by the National Fire Protection Association. The LSC is intended
to provide a level of life and occupancy safety necessary to protect patients, per-
sonnel, visitors and property from fire, smoke and other products of combustion. It
provides a process for inspecting, testing and maintaining fire protection and life
safety systems, equipment and components on a regular basis. In addition, each hos-
pital must develop policies and procedures that include written criteria evaluating
various deficiencies and construction hazards.
In the case of a NBC attack the following additional items and capabilities must
be contemplated:
Lockdown capability to minimize access to facility and facilitate direct patient
flow to specific points
246
Other security measures such as perimeter checks, hospital-issued staff photo
identification badges, visitor badging/identification and package handling.
Auxiliary power source
Increased storage capacity for fossil fuels to provide uninterrupted power
Portable negative air machines and HEPA filters
Large volume water purification equipment
Expanded mortuary facilities to manage bodies with high contamination or in-
fectivity potential
Designated hospital locations for personnel quarantine
Expanded patient isolation facilities, including separate air handling system
Expanded storage space for stockpiles of PPE, pharmaceuticals and supplies.

Per hospital egory

Dedicated decontamination facility

Patient decontamination is the process of removing or neutralizing hazardous
chemical, biological or radiologic agents from an injured or otherwise exposed indi-
vidual in order to reduce the risk to the individual and minimize secondary expo-
sure to health care workers and other patients in the facility. Hospitals should have
a minimal level decontamination facility for ambulatory and non-ambulatory pa-
tients for small events; the ability to ramp-up quickly for a medium level event; and
access to a regional decontamination facility for a large-scale event.
An outdoor facility or area can be effective, particularly to prevent contaminants
from entering a fixed health care facility. An outdoor facility also is suitable for han-
dling any large influx of injured or exposed individuals. It also holds the advantage
of not requiring a dedicated air-handling and ventilation system, as would be re-
quired in an indoor decontamination facility. There are several drawbacks, including
the requirement for providing protection from inclement weather and providing ad-
ditional lighting. Each hospital must consider all such relevant factors in making
a decision regarding appropriate decontamination facilities.
Hospital decontamination room, including:
Dedicated entrance from the ambulance entrance
Ventilation: negative pressure (minimum of 12 air changes per hour) and dedi-
cated exhaust with HEPA filter
Water supply: emergency eyewash and shower (with hot and cold water)
Waste water containment: Floor drain directs decontamination water to a com-
mercially available, 500-gallon hazmat-compatible (polypropylene) holding tank,
with sample port, bypass valve and extra holding tanks.
Electrical: Two explosion-proof pendant fixtures (not affixed to the ceiling), with
two 48 1 inch 32W T8 tubes per fixture with full electronic ballast; external
light switch, and; explosion-proof receptacles, protected by ground fault inter-
rupters.
Decontamination tables
Storage: PPE, medical and other decontamination room supplies should be
stored in a cabinet alcove outside the decontamination room. A hazardous waste
drum should be in the room for contaminated patient clothing, etc.
Provision for the storage and identification of patient clothing and personal
items/valuables, pending possible disposal requirements.
Provisions to extend decontamination into the parking lot or other large area
using portable units, including:
Outdoor shower systems with hot and cold water supply, with provision for sep-
arate showers for male and female patients
Adequate containment for run-off waste water
Separate tents for male and female patients
Portable generator(s) for power and for heating/air conditioning based on weath-
er
Portable lighting units for use during evening operations
Soap, dispensers, brushes, etc.
Facilities for safe collection, containment, storage and disposal of contaminated
materials
Extra patient linen for decontaminated patients and hospital scrubs as change
of clothing for hospital staff working in the decontamination room/area
247

Per hospital egory

Pharmaceutical and medical/surgical supplies

Hospitals must be properly stocked with antibiotics, antitoxins, antidotes, ventila-
tors, respirators and other supplies and equipment needed to treat patients in a
mass casualty event. We assume that external sources of drugs and related supplies
(e.g. CDCs National Pharmaceutical Stockpile) will be available within 24 hours of
the detection of a biological or chemical agent. Therefore, hospitals would have to
be prepared to sustain a 24-hour supply of pharmaceutical products at the most
common dosage for the estimated number of patients and hospital personnel. Provi-
sions and planning also must be made for appropriate dosages and formulations for
children who may be victims. For medical/surgical supplies and equipment, a stand-
ardized formula must be developed to adequately determine stock requirements.
In addition to needed pharmaceuticals and medical supplies that are directly re-
lated to attacks using biological or chemical agents, hospitals may need to increase
their in-house inventory of routine drugs, biologicals and medical supplies. As a cost
containment initiative, many, if not most, hospitals have very tight inventory con-
trols in place. If local transportation is disrupted or local warehouses destroyed, hos-
pitals will need to be able to survive for 2448 hours with on-hand pharmaceuticals
and supplies for all purposes until relief supplies arrive. The need to increase their
on-hand stock may be especially important for high-use items, such as insulin, that
are taken daily by large numbers of people with chronic conditions. If local retail
sources of such drugs become unavailable or local retail sources are unable to re-
plenish their stock, chronically ill individuals who lose access to their home supplies
are likely to turn to their local hospitals to access needed drugs and biologicals.
For pharmaceutical and other supplies used rarely in the normal course of hos-
pital activity, particular attention must be paid to appropriate dosing, shelf life and
stock rotation issues. A plan for pooling of resources through mutual aid agreements
among area health care facilities should be considered for such rarely used products
and supplies.
Suggested pharmaceuticals and related supplies
Bacterial agents: Ciprofloxacin, Doxycycline, Penicillin, Chloramphenicol,
Azithromycin, Rifampin, Streptomycin, and Gentamicin.
Botulism toxin: Mechanical respiratory ventilators, and other associated supplies.
Cyanides: Cyanide antidote kits containing amyl nitrite, sodium nitrite and so-
dium thiosulfate.
Lewisite: British anti-lewisite.
Nerve agents: Atropine, Pralidoxime chloride, and Diazepam (or lorazepam).
Pulmonary agents: Oxygen ventilators, and Respiratory care supplies.
All agents: Resuscitation equipment and supplies, Vasopressors and vasopressin
vials.
Other equipment and supplies
Mechanical respiratory ventilators (adult, pediatric, neonate), IV pumps and
poles, IV supplies (for 1,000 patients)IV Fluids-D5W, D5NaC1, D5 lactated Ring-
ers (need one per initial patient) In-dwelling catheters (need one per initial patient
in each size), IV sets (enough to handle one per initial patient)Suction machines,
Stretchers, Wheelchairs, Linens, and Bandages and dressings.

Per hospital egory

Training and drills

Staff training is needed at all levels of the organization for all types of potential
disasters: nuclear, biological, chemical and conventional. The training needs to be
stratified by educational level, from general staff awareness to technician level. Fur-
248
ther, drills must be conducted at least twice a year, according to requirements of
the Joint Commission on the Accreditation of Healthcare Organizations, (JCAHO),
and involve all key staff. Additional disaster drills beyond those required by
JCAHO, particularly those integrated into local/State/Federal disaster drills, would
enhance the level of hospital readiness and staff competence in the event of a mass
casualty incident.
Training: Using Web-based format with hard copy materials for all levels of
staff on mass casualty event awareness and preparedness (initial orientation,
annually, periodic)
Development of on-site disaster-response training courses (equipment, supplies,
course manuals, trainers). This would include, but not be limited to, clinical
training on biological and chemical topics involving staff from ER, urgent care,
primary care, laboratory and others involved in emergency response. Should in-
clude training on pediatric casualties.
At least two drills annually: Functional exercise, full disaster drill, and addi-
tional hours on development of the scenarios and logistics.
Training on the use of personal protective equipment
Training on set up and use of decontamination systems

Per hospital egory

Mental health
Survivors of mass casualty events and responders to such incidents (fire, police,
rescue workers, health care professionals, etc.) will suffer not only physical injury
requiring medical care but also will undoubtedly undergo extreme psychological
trauma. Thus the deployment of chemical, biological or nuclear agents against a
population produces both acute and chronic psychiatric problems. In a disaster, sev-
eral different groups would require mental health services, both direct and indirect:
Individuals presenting at the door or brought to the facility by rescue personnel,
including those who have specialized needs such as pregnant women, children,
elderly, or those who have an underlying mental health problem that may or
may not have been previously treated;
Fire, police and rescue workers injured while attempting to save a life
Injured individuals, including children, who have witnessed the death or serious
injury of a family member or colleague;
Family and friends of the missing, injured or dead. This group may suffer men-
tal distress that may require immediate mental health services or physical
treatment;
Worried well individuals who may need reassurance that they are not ill;
Administrative staff responsible for making decisions that affect the facilitys
ability to quickly respond to a mass casualty disaster;
Communication/professional staff to handle media inquiries and present accu-
rate and appropriate information so that the general public and institutions will
be able to process the information; and
Facility staff working the disaster to ensure they are mentally and physically
fit. There would be an immediate on-site need for critical incident stress debrief-
ing to be conducted for those providing trauma and triage care.
Beyond physical injuries, individuals who have survived a disaster also would be
experiencing extreme emotional distress that could also manifest in physical condi-
tions. This could include, but not be limited to, physical shock, hysteria, anxiety,
fear, anger, frustration, and guilt, as well as an inability to communicate informa-
tion critical to their treatment. For example, a survivor with a heart condition or
asthma may require both immediate physical help and crisis intervention to be able
to calm down and prevent further injury or distress. Finally, some individuals also
may want to leave facilities to find loved ones or colleagues or to return to a safe
place, whether or not they are physically or mentally able to do so. This might re-
quire close monitoring or short-term containment.
The following estimate was provided by the New York-Presbyterian Healthcare
System, 525 E. 68th Street, New York, NY, whose recent experience provided some
answers regarding this question. According to their estimate, triage and initial eval-
uation for one day of 1,000 individuals (assuming an average salary of $75,000)
would require that 31.25 FTEs provide four direct service evaluations per hour. This
249
would be a direct cost of $9,375 per day. In addition, administrative services would
cost $2,500 per day with total service personnel of $11,875. Other costs would in-
clude additional security, medications and administrative costs of $10,000, for a
total of about $22,000 for a metropolitan hospital. We assume that a non-metropoli-
tan hospital would bear about half the total cost of a metropolitan hospital.

Per hospital egory

Totals: Metropolitan Hosp .................................................................................... 3,027,000 8,172,900,000
Totals: Non-metropolitan Hosp ............................................................................ 1,439,500 3,166,900,000
Totals .................................................................................................................... ........................ 11,339,800,000
Senator HARKIN. Thank you, Dr. LeValley.

I want to call a brief recess here. When I come back I would like
to cover just the following things. Dr. Alibek, I just want to ask
you, do you think we are maybe overreacting? I want to just delve
into that a little bit with you. Are we overreacting or not in this?
We will get back to that when I get back.
Dr. Barbera and Dr. LeValley, I want to talk about this question
you raised, Dr. LeValley, about what is the adequate level of pre-
paredness. We cannot prepare for every possible contingency, so we
have to prioritize. What is the first thing that we have to do and
what does that cost, and what level of protection did we provide for
the American people in our hospital systems across the country?
Obviously, we just cannot cover everything, but we have to think
about what is it that gives the maximum amount of protection to
the American people in the realm in which we are working right
now, and how much is that going to cost and how soon do we need
to do it? So I am going to come back and ask you what the prior-
ities are out there, since we cannot fund everything.
So we will have a brief recess. Maybe, Dr. Koplan, you can get
those figures, because, as Senator Specter said, we have got to get
this budget put together before the end of the week.
So we will have a brief recess and the subcommittee will be back
in about 15 minutes.
[Recess from 10:42 a.m. to 11:04 a.m.]
Senator HARKIN. The subcommittee will resume.
Dr. Alibek, before I left I said I wanted to ask you a couple of
questions. Again, I want to know if we are overreacting, because
a couple of years ago, we had this Japanese cult that released some
sarin gas in Tokyo in the subways and it just did not work on a
broad basis. Even with the anthrax, it seems to be very difficult to
do on a broad-basis.
Now that the initial wave has hit, people are now thinking about
what we have to do. Are we overreacting? Is it very likely that bio-
logical weapons that were manufactured in the Soviet Union have
been obtained by other nations?
You said that the former Soviet Union had genetically modified
smallpox and other agents. Would the smallpox vaccine that we are
talking about here, will it work against the modified smallpox?
250
Dr. ALIBEK. It would.

Senator HARKIN. It would.
Second, what do you think about this? Are we overreacting or
not?
Dr. ALIBEK. I would like to say we are overreacting, but unfortu-
nately I cannot say this. The problem is this: When we discuss bio-
logical weapons, what is the difference between a biological weap-
ons threat, a bioterrorism threat, and some other threats we have
already faced? We noticed that this anthrax threat was a long-term
continuous threat. We saw how people reacted. The entire popu-
lation was in a state of fear or scare.
What is important to say in this case is that this attack was the
least effective attack you could imagine, because letter-borne de-
ployment is not very effective. I would say it is the least effective.
In this case, think what could be done if they are able to use some
other techniques to deploy biological agents. I am not going to
elaborate what kind of techniques they could use, but, believe me,
there are many different techniques.
I do not want to be a bad messenger, but in my opinion it is sort
of the beginning of the process. We will be seeing some new at-
tempts to deploy biological agents in the future.
But when we say it was not very effective, for example the Japa-
nese cult using sarin gas, and then the anthrax scare or attack
here in the United States, in my opinion it is a first attempt. Even
these first attempts showed how scary this thing could be. In this
case, in my opinion we need to put it on a scale: What kind of con-
sequences could we expect in case we have a large biological weap-
ons attack somewhere in the mall, one of the malls, or metro sys-
tems, and so on and so forth. You can imagine what kind of dam-
age, psychological and economic damage, this type of attack would
bring to the United States.
In my opinion, we are not overreacting. We do what we need to
do, and in my opinion we need to do more to be better prepared.
Senator HARKIN. I appreciate that.
One last thing. You mentioned the scientists that have a lot of
expertise in this area. You mentioned in your testimony and in
your written testimony, that they have a lot of expertise and that
they could be used. Where are these scientists now? Are they still
in Russia, are they here? Where are they?
What would it take to be able to enlist them? I think what you
said is, because of the knowledge base they have, that knowledge
could also be used to help develop defenses against biological weap-
ons. Is that not what you said?
Dr. ALIBEK. Yes.
Senator HARKIN. Where are all these people?
Dr. ALIBEK. It is a very interesting question. Of course, maybe
I am not an appropriate person to answer this question because I
have never done intelligence work to find out where these people
are. My knowledge is coming from my talks with some former Rus-
sian scientists and some discussions with some other people. For
example, I know that many of them are here now in the United
States. In my opinion, about between 70 and 100 scientists are in
the United States.
Senator HARKIN. Are here?
251
Dr. ALIBEK. Yes, in the United States. Quite a significant num-

ber of people are in Europe, in Eastern and Western Europe; some
of them are in Asia, Japan and some other Asian countries. We
know about some scientists working as professors and faculty in
Iran, teaching Iranian students. There was a rumor that some of
them left for Iraq, but it was rumor. Of course, we cannot prove
this.
There are quite a significant number still in Russia, and many
of them are in the former Soviet Union countries, which are inde-
pendent countries now.
I would say these scientists are scattered all over the world now.
In my opinion it is important to discuss this issue of Russian sci-
entists. We discussed smallpox, for example, and we know that in
the United States we have got significant knowledge of smallpox.
At the same time, a huge study was done on smallpox, regarding
how to develop protection and how to develop biological weapons,
in the former Soviet Union. A lot has been done with anthrax.
These people have sophisticated knowledge about how to work with
anthrax.
But at the same time, for many diseases like glanders, like
melioidosis, brucellosis, tularemia, Ebola infection, Marburg infec-
tion, and so on and so forthI can continue this enumeration end-
lesslywe have no sophisticated knowledge here in the United
States. But these people, theyve got this knowledge and they could
be very good assets to help us understand what kinds of protection
we can develop and understand the pathogenesis of these infec-
tions.
Just to prepare a good scientist in this field who is able to work
under BL3, BL4 conditions and do this necessary work, it could
take years and years or even decades, and it would cost millions
of dollars. But we have got ready-made scientists and they are able
to accumulate this knowledge here in the United States. In my
opinion, they could be a perfect asset to help the United States de-
velop protection against biological weapons and against bioter-
rorism.
Senator HARKIN. Thank you, Dr. Alibek. It seems to me we could
make agreements with Russia. It would seem that they have as
much interest in this as we do. But that is out of the realm of my
subcommittee.
Dr. Barbera and Mr. LeValley, I asked you when I left to
prioritize. Since we cannot do everything, what can we do now to
help our local hospitals be at least somewhat prepared for what we
know would be some of the major things that might happen? We
know we cannot do everything, but what are the first things we
need to do and ought to be paying attention to here with the money
that we are appropriating?
Either one of you. Mr. LeValley?
Mr. LEVALLEY. Well, Senator, I think we all understand that, as
I mentioned in my testimony, it is an unanswerable question. I
think you are probably aware the American Hospital Association
has done some work on some broad-based estimates using some
pretty broad rules of thumb and came up with a figure of over $11
billion that hospitals could use to better prepare, based on the as-
252
sumption that we would want large urban centers like Mercy to be

able to handle 1,000 casualties.
I think as we debate those kind of numbers, we can debate how
many hospitals need to be ready for what level of care and what
can the government afford, and all those are very legitimate issues.
One thing I might suggest to try to get to your issue of
prioritizing. Rather than rely on my perspective, we may want to
convene a group with the Iowa Hospital Association, for example,
and get some clinicians and others together and provide you a writ-
ten response to that question of how would hospitals prioritize. I
might make that offer to you. I would be happy to coordinate that
on your behalf, to pull some people together and get some addi-
tional minds other than mine in terms of the priorities.
From Mercys perspective, I can tell you that if you took the
American Hospital Association numbers, and I just did the calcula-
tion quickly last night in Mr. Waters office, roughly about $3 mil-
lion would flow to Mercy Medical Center. I can tell you as we sit
here today that we could spend that $3 million to significantly im-
prove our preparedness and not any of it would be wasted.
We have very real needs to improve our emergency department,
to improve our security systems, to increase our pharmaceutical
supplies and vaccines and all those things. I made kind of a laun-
dry list here in my notes about laboratory and diagnostic capability
expansion.
Compounding this problem of the terrorist threat is the fact that
Americas hospitals are experiencing capacity problems all across
the Nation already. We have a bit of a crisis going on in hospital
care to begin with. In Des Moines, not just Mercy, but all Des
Moines hospitals have had numerous days in the last year or two
where we have been full, with no beds available. We have had nu-
merous days where emergency departments have been forced to
turn away patients, divert patients to other places, because they
did not have the capacity.
If an attack like this were to occur on a day when our beds were
full and people are already being diverted, we would have a true
catastrophe on our hands.
But to answer your question then, do we say as part of our ter-
rorist preparedness that we want to expand the bed capacity and
physical plants of all of our hospitals? That number would be enor-
mous. So I think it is a very difficult policy question and we have
lots of needs. Our commitment to you would be to put to very good
use whatever funds you can come up with for hospitals to help us
improve our preparedness.
Second, I would just hammer home this issue that, if we are
going to have nurses in the future, if we are going to have physical
capacity in the future to deal with our health care needs, we have
got to have adequate reimbursement day in and day out. Think
about trying to recruit nurses and the whole smallpox issue. Think
about what we are going to have to be paying people in the future
as these threats are elevated and emergency staffs and nursing
staffs are being asked to take care of these kinds of risks. The costs
of that are only going to rise, and if the government keeps reducing
what they pay us, as currently proposed in the outpatient capital
253
process and the physician reimbursement process, we are really

headed for disaster.
Senator HARKIN. That is on another track we are trying to ad-
dress right now.
Mr. LEVALLEY. We appreciate it very much.
Senator HARKIN. But I see what you are saying. I think, to inter-
pret what you just said, Mr. LeValley, it is hard to focus on build-
ing this extra additional capacity when the basic fundamental ca-
pacity and support structure is being eroded.
Mr. LEVALLEY. Absolutely.
Senator HARKIN. That is what we are facing.
Dr. Barbera, you spoke about what is adequate and reasonable.
I am not certain I could define what is adequate. That is what I
do not know. That is what we as appropriators are trying to get
a handle on: What is adequate and what is reasonable?
You said in your testimony: The difference between adequate
and reasonable is wide and it is unacceptable to the American pub-
lic. What are those parameters? I just do not know.
Dr. BARBERA. I do not think we know what adequate is, but I
think what we need is an objective process to decide what we think
it is and whether or not we are going to make a conscious decision
whether we are going to try to reach that or not.
I can tell you somewhat what reasonable preparedness is. We as
the hospital community in the District of Columbia have recognized
for a while that mass terrorism is a possibility, a very real possi-
bility. In 1995 we developed a hospital mutual aid system. We rec-
ognized from research and other things, multiple things.
One thing is, in major mass casualty events 80 to 85 percent of
patients get to hospitals without EMS, even in the best-trained
EMS system. So contaminated patients and others are going to
show up at hospitals no matter how well prepared our hospital
community is.
We recognize also that in most mass casualty events the regional
hospital capacity is rarely exceeded. It is a problem of medical
needs being in places where there are not the medical resources.
We saw that in Oklahoma City, where many of the casualties ar-
rived at St. Anthonys 5 minutes from the Murrah Building, where-
as hospitals were prepared and standing by only a few minutes fur-
ther on and got very few patients.
So we developed a mutual aid system so that we can call each
other for help and we can offer assistance, recognizing that you can
move medical staff, nursing staff, and equipment better than you
can move critically ill patients. So we have tried to maximize what
we have here in the District. Indeed, when we had a fire in the
Foggy Bottom Metro Station across the street from George Wash-
ington Universitys main entrance and we did not know whether it
was accidental or terrorist, we activated the system and had plenty
of capabilities that could have responded if we suddenly had 200
badly injured, smoke-ingesting patients who came up from the
Foggy Bottom Metro stop.
That is part of what we would call reasonable. At George Wash-
ington University Hospital, we developed a low budget mass cas-
ualty decontamination system. We made some assumptions and we
254
moved forward, so that we can wash off a significant number of pa-

tients quickly. Those are some of the things that are reasonable.
But in terms of adequate, we truly need a surge capacity, and
a surge capacity is not regular business. If you are using your
surge capacity on a regular basis, it is not surge capacity. Anyone
who looks at the business of anything says if you develop capacity
and you are funding capacity that does not bring you anything
back that is a stupid business idea. And medicine and hospitals can
no longer afford any sort of those types of ideas.
Senator HARKIN. But if I might interrupt you, for surge capacity
you just need locations, sites, you need facilities that can be requi-
sitioned, is that not the idea for quarantine purposes and treating
purposes?
Dr. BARBERA. On a regular day most hospitals are close to their
capacity for critical care patients.
Senator HARKIN. I understand that.
Dr. BARBERA. So you need locations, you need equipment, you
need staff that can provide critical care services. We saw with Sep-
tember 11th in the D.C. area and I think in the New York City
that area hospitals stepped up. Hospitals from the Baltimore area
called our communications system and offered their services de
novo. Hospitals will do what they can. But if these are bioterrorism
events or things that are going to go long term, we have to look
at what you are going to do to hospitals.
You can close down your operating rooms and use the post-opera-
tive area, the post-anesthesia or recovery room area as a critical
care area, but you have just killed off your operating income for the
hospital. How long can you do that, and is there a mechanism to
recover that if you have done that for the communitys benefit?
What happens if you have accepted large numbers of contagious
patients potentially with contaminants on them? How do you con-
vince the public that it is time to come back to your hospital, that
it is clean? And do you recover in some manner the business losses
that you have for doing that? This is not looking at profit. This is
looking at maintaining an everyday capacity in your community.
These are difficult questions. So I would say you would like to
prioritize these things, starting with what are relatively cost-effec-
tive mechanisms to develop a surge capacity across the region that
is sustainable and multi-hazard. That is why we used our mutual
aid system. We also have to prioritize the protection of hospitals,
their staff and current patients from patients who are coming in
that could inadvertently be a threat to the facility or staff.
We have to look at the security interests of hospitals. We all rec-
ognize that the terrorism modus operandi is secondary hits, and we
also recognize that they are not like in the old days, where there
were some general rules, so the hospital could very well be the sec-
ondary hit. Hospitals do not have extra money to have standby se-
curity capacity.
So there are a lot of these issues. I think we can prioritize them
based on cost-effective considerations, such as how do we maximize
what we have using information systems and communications sys-
tems, how do we have an integrated system between public health
and emergency medicine and the hospitals and emergency manage-
ment, how do we bring regional and Federal resources in to assist
255
the hospitals, how do we work closely with the U.S. military med-
ical capacity and the hospitals?
I think we have developed a model here in Washington, D.C.,
using the mutual aid system, with Walter Reed, Malcolm Growe,
the National Naval Medical Center, and the Veterans Hospital. We
have offered help to each other when we have had problems inter-
nally at hospitals.
So there are things we can do, but there are adequate things
that we have not defined yet.
Senator HARKIN. Thank you very much, Dr. Barbera, Mr.
LeValley, Dr. Alibek. Thank you very much for being here and for
your expert testimony. I appreciate it. You have given some good
suggestions we are going to follow up on.
One thing we have really got to work through with the Centers
for Disease Control and with hospitals around the country is that
there have to be plans in effect for these kind of surge capacities.
There has to be some plans in effect, maybe not in every locality,
but at least I think in major metropolitan areas, where the rate of
contagion can be more rapid than, let us say, in a dispersed area.
I am not certain that we have those kind of plans in effect right
now.
Mr. LEVALLEY. If I might, Senator, I think every hospital does
have a disaster plan.
Senator HARKIN. Oh, I understand that.
Mr. LEVALLEY. I think at least in Iowa the coordination and co-
operation between hospitals is wonderful, as we saw in Sioux City
with the 232 crash. There is good response capability for 100, 200
casualties. I think it is when we get up into those big numbers that
everything is really at risk.
Thank you.
CONCLUSION OF HEARINGS

The subcommittee will stand in recess until Tuesday morning,
when we will have a hearing on cloning.
[Whereupon, at 11:26 p.m., the hearings were concluded, and the
subcommittee was recessed, to reconvene subject to the call of the
Chair.]

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SUBCOMMITTEE ON DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND

WEDNESDAY, OCTOBER 3, 2001

TUESDAY, OCTOBER 23, 2001

FRIDAY, NOVEMBER 2, 2001

THURSDAY, NOVEMBER 29, 2001

WEDNESDAY, OCTOBER 3, 2001

Senator HARKIN. Good morning. The hearing of the Appropria-

appeared to be just an unusual case of influenza are recalling

For example, in New York, a doctor who had recently attended

2 Supplement to the Journal of the American Pharmaceutical Association, September/October

PREPARED STATEMENT OF THE AMERICAN SOCIETY OF CLINICAL PATHOLOGISTS

PREPARED STATEMENT OF THE COMMISSIONED OFFICERS ASSOCIATION OF THE U.S.

PREPARED STATEMENT OF THE ASSOCIATION OF STATE AND TERRITORIAL HEALTH

Public health workforce

Senator SPECTER. Thank you very much, Mr. Chairman, and

retary Thompson insisting that the Government: can handle any

ators who are on authorizing committees that are very important

more important problem facing us as appropriators, or as author-

While we worked very closely on this legislation and will con-

comes to about $1.8 billion. In terms of our recommendations this

ing out the information that is important for us to recognize in

Second, the threat has increased because of technology, and you

the first 24 hours, so you have to be able to detect itafter 24

Mr. Chairman, we sort of laid a template in the bill that we put

Our first national priority must be enhanced on-the-ground intelligence to know

Even if we do all that we can to prevent a bioterrorism attack, our preparedness

Once preparedness is maximized, the key to response and mitigation of disaster

It needs to be made available now, but it could be multiyear in

Again, I thank the Senators, and please stay or leave as you so

I would summarize my thoughts on this by saying, Mr. Chair-

crash. There would be no catastrophic event of any type. Instead,

Senator HARKIN. Thank you all very much. I thank Senators

ACCOMPANIED BY DR. SCOTT LILLIBRIDGE

within the State and local partners who depend so much on a

This program, ladies and gentlemen, would put uniquely trained

our stockpiles, our institutions, and our products, and throughout

If a terrorist used a biological or chemical weapon against the civilian population,

In conclusion, the Department of Health and Human Services is committed to en-

think we need to do more to heighten their public appearances out

Senator SPECTER. So that will be available to Secretary Thomp-

ists in preparing the local and State officials to adequately deal

When you are the chairman of the Appropriations Committee, I

Senator DEWINE. Mr. Chairman, I will be very brief.

have an immense challenge, certainly not a challenge we cannot

Senator DURBIN. Thank you, Mr. Chairman. I want to thank the

We have, as I mentioned earlier, a dozen agencies, and 35 dif-

Senator GREGG. Thank you, Mr. Chairman. Mr. Secretary, it is

The chairman, in opening this hearing, in fact went into some

Government-owned contractor-operated facility for vaccines. We are

Senator KOHL. Governor Thompson, good to see you.

second, in the absence of disease, we would be confronted with

Secretary THOMPSON. I appreciate that. Thank you very much.

In the event of a major outbreak of disease, whether the result