PUBLIC CITIZEN HEALTH RESEARCH GROUP

SIDNEY M. WOLFE, M . D. , EDITOR SEPTEMBER 2002 + VOL . 18, NO . 9

The Invisible Plague:

The Rise of Mental Illness from 1750 to the Present
It is exciting for us to review a book out is a brilliant, unprecedented review writer describing mental illness and the
written by one of our colleagues and of dozens of fictional writers such second from Daniel Defoe's A]ournal
staff members who bas been working as Coleridge, Wordsworth, Byron, of the Plague Year, 1722, a similarly
with us since the Health Research Shelley, Dickens, Lewis Carroll, Yeats, well-researched book based on the
Group began, almost 3 1 y ears ago. Dr. Joyce, Melville and others, their per- late-17th century London plague out-
E. Fuller Torrey, an internationally sonal or family history of serious men- break. Chapter 4, for example, begins
known psychiatrist and anthropologist tal illness and its evidence in their writ- with Defoe's:
is president of the Treatment Advocacy ings. The reader is reminded of the
Center in Arlington, Virginia, has comparison to the more well under- For it was indeed a dismal time,
extensive experience treating people stood and highly visible plagues such and for about a Month together,
with serious mental illnesses such as as the Black Death or bubonic plague not taking any Notice of the Bills
schizophrenia, manic-depressive ill- at the start of each chapter in the book of Mortality, I believe there did not
ness (bipolar disorder), and major by a pair of quotes, the first from a continued on page 2
depression and has been a leader in
research concerning the causes ofthese
diseases. He is also currently professor CONTENTS
ofpsychiatry at the Uniformed Services
University of the United States and Update on the Illegal Promotion of Gabapentin (Neurontin)
ex ecutt"ve director of the Stanley There are two reasons you should be using this drug. But that's not
Medical Research Institute. what the drug company is telling doctors . .... ... ..... ....................... ...... 3

(Tbe Invisible Plague: Tbe Rise of Product Recalls

Mental Illness from 1 750 to the July l~August 7, 2002
Luvox tablets, syringe kits and puzzles are on our list this month . . 6
Present, by E. Fuller Torrey and Judy
Miller, published in 2001 , is available Pressure On To Ban Ephedra
at major bookstores, from Rutgers We report another case of the damage done by this dangerous
University Press (1-800-446-9323), supplement. ... ...... ..... .............. ... .... ............ .... ..... .. ... ... .. ....... ...... ............ 9
and on the Internet at Amazon.com
and BarnesandNoble.com. West Nile Virus Activity
The Centers for Disease Control tells us exactly where cases
of this disease have been reported ......... ... ........ .. .. ....................... .. .. .. lO

T
he Invisible Plague: Tbe Rise of
.Mental Illn ess from 1750
to the Present, combines a
Outra]le of the Month
Health Research Group Asks for Metabolife President to
meticulously researched history of the be Investigated.
sharp increases in the prevalence of He lied to the FDA. What are they going to do about it? ... .............. l2
serious mental illness with the chang-
ing societal reactions to this relatively
invisible plague. Interwoven through-

VISIT HEALTH RESEARCH GROUP'S WEB SITE AT WWW.CJ'fiZEN.ORG/IIRG/

 die less than 1500 or 1700 a Day, the seriously mentally ill. The best ty were first being sounded, surveys
one day with another. aspects of Dix also characterize an were carried out in the United States
important aspect of Dr. Torrey's work as well as in several European coun-
Dickens was remarkably knowl- and advocacy in that he has made tries. These reports uniformly report-
edgeable about insanity and depict- dozens of unannounced visits to ed that the prevalence of insanity was
ed insane characters in 1be Pickwick mental illness treatment facilities under 1 case per 1,000 population.
Papers, Barnaby Rudge, and David such as hospitals and clinics, docu- By the later years of the 19th century,
Copperfield. He had an extensive mented the problems and frequently repeat studies revealed that the
library of psychiatric books, was presented these outrages to the pub- prevalence had increased. In the
close friends with prominent psychi- lic with the result that important United States, for example, the 1880
atrists and members of the Lunacy improvements sometimes followed. census included a special initiative to
Commission, which inspected insane It is widely assumed that the identify every insane person, includ-
asylums, and regularly visited asy- prevalence of severe psychiatric dis- ing those in hospitals, jails, and work-
lums himself. During his 1842 visit to orders has remained constant over houses as well as those living at
America, Dickens visited two asy- many centuries. Such disorders are home or elsewhere in the communi-
lums. In 1857, in "The Lazy Tour of now called schizophrenia, manic- ty. It was the most complete enumer-
Two Idle Apprentices," published depressive illness (bipolar disorder), ation of severely psychiatrically ill
with Wilkie Collins, Dickens and major depression, but until a individuals ever carried out, before or
described a fictional visit to an century ago, they were together sim- since, in this country. The census
insane asylum, including a poignant ply called insanity. Virtually every reported that the rate had more than
description of patients standing idly federal, state, and county mental doubled since earlier in the century
on the wards of the asylum: health planning group assumes that to 1.8 insane persons per 1,000. By
the prevalence of these disorders is 1955, the prevalence of hospitalized
Long groves of blighted men-and- constant, and virtually every text- individuals with severe psychiatric
women trees; interminable avenues book of psychiatry assures us that disorders, not including those in jails,
of hopeless faces; numbers, without this is so. public shelters, or living at home had
the slightest power of really combin- A careful analysis of available reached 3.4 per 1,000. More recent
ing for any earthly purpose; a soci- records, however, suggests that this surveys carried out through the
ety of human creatures who have assumption is wrong. Insanity, a tra- Epidemiologic Catchment Area CECA)
nothing in common but that they ditional shorthand for severe psychi- survey and National Comorbidity
have all lost the power of being atric disorders, has increased at least Survey (NCS) suggest that by 1990
humanly social with one another. fivefold, as a rate per population, the prevalence of severe psychiatric
over the past 200 years and may be disorders was more than 15 per
Lewis Carroll was also intrigued by continuing to increase. This increase 1,000.
insanity, partly because his uncle and in prevalence would help explain the In addition to such prevalence
closest friend was a member of the continuing increase of individuals surveys, incidence surveys of first
Lunacy Commission. Carroll testified with severe psychiatric disorders admissions have also shown a pro-
before an 1859 Royal Commission among the homeless and in jails and gressive increase. For over a century,
investigating the increase in insanity. prisons. It would also help explain state psychiatric hospitals were con-
It is well known that Carroll used why the planning of services for tinuously being built and expanded,
insanity prominently in such works as these individuals, by both govern- and almost immediately filled to
Alice in Wonderland and Through the ment agencies and managed care overflowing.
Looking Glass. What has heretofore companies, has so badly underesti- The apparent increase in insanity
not been described is the fact that mated the need for these services. It over the past two centuries has been
1be Hunting of the Snark is an alle- has been a recurring theme in plan- widely explained by psychiatric his-
gorical account of the Lunacy ning services in recent years that torians as simply the shunting of
Commission and the death of whatever numbers of severely psy- troublesome persons from the com-
Carroll's uncle, who was killed by a chiatrically ill individuals are planned munity to state hospitals. According
psychiatric patient (see story at for, the numbers actually needing to the authors, an examination of the
http:// www.richmondreview.co.uk/ services are invariably much greater. historical records , however, does not
library/torreyO 1. html). What evidence is there that the support this interpretation. These
A heroine for the authors of 1be prevalence of insanity is increasing? records show that the individuals
Invisible Plague was the 19th century According to the authors, there is no being hospitalized were not merely
mental illness crusader, Dorothea single smoking gun that proves it but "troublesome persons" but rather
Dix. Her visits to asylums for the rather an accumulation of data that all gave clear evidence of having severe
insane and her advocacy on their point in the same direction. For psychiatric disorders. The records
behalf had a remarkable impact on example, in the early 19th century, also indicate that the building of state
awakening people to the plight of when alarms about increasing insani- continued on page 3

2 + September 2002
 Update on the Illegal Promotion of
Gabapentin (Neurontin)
n the May 2002 issue of Wor.st This article is based on allegations approval. Instead, company officials

I Pills, Best Pills News, we wrote

about gabapentin (NEURONTIN),
a drug approved by the Food and
made in recently released court doc-
uments.
Gabapentin was originally pro-
developed a strategy that would
allow Parke-Davis to avoid the costs
of proving gabapentin's safety and
Drug Administration (FDA) for treat- duced by Parke-Davis, which was effectiveness for these other uses,
ing seizures, a somewhat limited acquired by Pfizer, Inc, of New York while allowing the company to enter
potential market, that was illegally in 2000. The only FDA approved use the lucrative off-label markets.
transformed into a "blockbuster" drug for gabapentin at that time was as an Taking advantage of a loophole in
with sales approaching $1.5 billion in add-on treatment for epilepsy. This is the FDA's off-label marketing rules,
2001. The metamorphosis was a very limited market with little Parke-Davis decided to employ a
accomplished by fabricating a num- upward potential for sales. The new "publication strategy" that would
ber of uses for the drug that are not court documents allege that Parke- allow it to promote gabapentin by
FDA approved. These included bipo- Davis knew that pain management, the massive distribution of publica-
lar disorder, attention deficient disor- psychiatric disorders, anxiety and tions supposedly written by inde-
der, and migraine. The use of a drug depression were immense markets pendent researchers who purported-
that is not approved by the FDA is which, if tapped, could yield enor- ly described the scientific evaluation
referred to as an "off-label" use. mous profits from sales of gabapentin. of gabapentin. Another advantage of
The May article was based on New this strategy, from the company's
York Times reporting and documents The Decision to Promote perspective, was that it could be
from the United States District Court Gabapentin for Unapproved Uses done immediately. There was no
for the District of Massachusetts. This Documents revealed that after an need to wait for the results of scien-
court recently released new docu- extensive economic analysis, senior tifically conducted clinical trials to
ments that for the first time gave the officials at Parke-Davis determined determine if gabapentin was actually
public an inside picture of the lengths that it was not sufficiently profitable effective in the treatment of these
to which a pharmaceutical company for Parke-Davis to obtain FDA conditions and submit them to the
will go to sell a drug even when there approval for gabapentin's alternative FDA for approval.
is no evidence that it is safe or effec- uses mentioned above by doing the
tive for the uses being promoted. types of studies necessary for continued on page 4

THE INVISIBLE PLAGUE, such things as changing exposure to causing society to move much more
frompage2 infectious agents (e.g., paralytic polio effectively to do something about it.
hospitals was in response to a per- increased as sanitation improved and Toward the end of the book, the
ceived need, that there was much young children were thus no longer authors quote from the Final Report
taxpayer resistance to building them, exposed to its innocuous early child- of the Joint Commission on Mental
and that families were usually reluc- hood form), toxins (e.g., PCB's affect Illness and Health's 1961 report:
tant to have their sick family mem- mental development in childhood),
bers hospitalized. or dietary changes. At this point in 1be way society handles it mental-
The authors believe that the most time, the authors admit that we can- ly ill has been the subject of scan-
likely explanation for the apparent not say for certain what might be dalized public attack many times.
increasing prevalence of insanity is causing increasing insanity. The Humane, healing care for the
simply that it has been truly increas- important thing is to recognize that mentally ill ... remains the great
ing. Existing data suggest that this insanity appears to be increasing unfinished business of the mental
increase has corresponded closely and, they argue persuasively, we health movement.. .A large propor-
with increasing urbanization. The must proceed with the necessary tion of mental patients in the pres-
increase does not appear to be relat- studies to ascertain why. ent, as in the past, are not treated
ed to social stress, since it appears to The book is an all-too-rare combi- in accordance with democratic,
have been unaffected by the World nation of medicine, history, sociolo- humanitarian, scientific and ther-
Wars or the Great Depression. Rather gy, anthropology and literature apeutic principles. We have sub-
the increase in insanity is most likely which will play an important role in stantially failed them on all
related to the biological antecedents making all the more visible this counts.
of the disease. These may include plague in our society and hopefully

Public Citizen's Health Research Group + Health Letter + 3

GABAPENTIN, from page 3 Parke-Davis would routinely ana- attendees based on their ability and
Paytnent to Doctors to Increase lyze whether the consultants' meet- willingness to prescribe high quanti-
Gabapentin Prescriptions ings were successful in getting doc- ties of gabapentin, evaluated the pre-
The company's "publication strate- tors to change their prescription writ- sentations to make sure Parke-Davis'
gy" required doctors to perform the ing practices. At some meetings, the "message" was appropriately deliv-
work normally performed by the so-called consultants were asked ered, black-listed presenters whose
company's sales force in order to directly if they would write more presentations were not sufficiently
promote gabapentin. This necessita- gabapentin prescriptions as a result pro-gabapentin, and monitored the
ted that Parke-Davis make tens of of the meeting. This question would prescribing patterns of the physicians
thousands of payments to the doc- have been irrelevant if the actual who attended.
tors who would act as a surrogate purpose of the meeting was to
sales force as well as to the practi- receive the consultants' advice. Grants and Studies
cing physicians who would receive Parke-Davis also routinely tracked Parke-Davis also made outright
the message. In other words, adop- consultants' gabapentin prescription payments, in the form of grants, to
tion of the "publication strategy" writing practices after these meet- reward demonstrated gabapentin
required the company to pay physi- ings. Parke-Davis actually analyzed advocates. Company sales managers
cians to either recommend the pre- whether the doctors they had paid identified key doctors who actively
scription of gabapentin or to order had in fact written more gabapentin prescribed gabapentin or programs
gabapentin, in violation of the feder- prescriptions after the meeting, using which were willing to host gabapentin
al anti-kickback regulations, accord- market data purchased from third speakers and encouraged such per-
ing to the newly released court doc- parties. sons or programs to obtain "educa-
uments. tional grants" from the company.
A description of the various pro- Medical Education Seminars Parke-Davis' sales people informed
grams Parke-Davis used to .make The court documents revealed leading gabapentin subscribers that
these payments to physicians fol- another platform used by the compa" significant advocacy for gabapentin
lows. ny to pay kickbacks to doctors to hear would result in the payment of large
off-label promotion of gabapentin. grants. These studies did not involve
Consultants' Meetings These were programs billed as significant work for the physicians.
A common trick used by Parke- Continuing Medical Education (CME) Often they required little more than
Davis to funnel illegal payments to seminars. These conferences and collating and writing up office notes
doctors to encourage them to pre- seminars were set up to appear to or records. Parke-Davis frequently
scribe gabapentin off-label was qualify for an exception to the FDA's hired technical writers to write the arti-
through "consultants'" meetings. off-label marketing restrictions which cles for which the "authors" had been
Under this front, Parke-Davis invited permits doctors to learn about off- given grants.
doctors to dinners or conferences label uses of drugs at independent
and paid them to hear presentations semin2.rs. Such seminars, however, Payments to "Authors" of
about off-label uses of the drug. must be truly independent of the drug Ghost- Written Articles
Under the guise that these doctors companies. The companies may Another method of paying off
were acting as consultants, Parke- make "unrestricted grants" for the doctors for backing gabapentin was
Davis sometimes, but not always, purpose of a seminar, but may not be to pay honoraria for the use of their
had the doctors sign bogus consult- involved in formulating the content of names on scientific articles intended
ing agreements. At these meetings, the presentations, picking the speak- for publication in various neurology
the company would give these doc- ers or selecting who attends the sem- and psychiatry journals, but actually
tors lengthy presentations relating to inars. Parke-Davis retained third party ghost-written by technical writers
gabapentin, particularly regarding companies to present seminars while hired by Parke-Davis, which retained
off-label usage. Presentations would in fact retaining control of virtually control of all such articles. In 1996
be made by Parke-Davis employees every aspect of these events. The Parke-Davis paid for at least 20 such
or physician speakers hired by the seminar companies obtained Parke- articles, most of which dealt with off-
company for the purpose of promot- Davis' approval for all content pre- label use of gabapentin, and were
ing gabapentin, and questions relat- sented at the seminars. Parke-Davis placed according to the company's
ing to the use of gabapentin would also paid all expenses, including all "publication strategy." Naturally,
be solicited and answered. At some the seminar companies' fees. Parke-Davis paid all expenses in
conferences, the sponsoring organi- The company designed and connection with these articles.
zation or Parke-Davis intentionally approved the seminars, hand-picked Once Parke-Davis and the techni-
posed questions to the speakers the speakers, approved the seminar cal writers conceived the articles, the
about off-label use to insure that the presentations, previewed (in most company and its outside firms
doctors were exposed to such infor- cases) the contents of the seminars attempted to find recognized
mation. prior to a presentation, selected the gabapentin prescribers whose names

4 +August 2002
could be used as the authors of these into public view. Because of the journal to accept a study for publica-
articles. In some cases, drafts of the detail of fabrications, pay-offs, tion. The FDA bases its drug
articles were completed even before manipulation, and their effect on approval decisions on its own review
an "author" agreed to place his or her gabapentin sales some widely held of the actual data submitted by a
name on the article. This even myths have been shattered. manufacturer, not on published jour-
occurred in connection with case his- First, and perhaps the most impor- nal articles. The agency has a staff of
tories that purported to describe the tant to the health and safety of highly trained statisticians who do
"author's" personal treatment of actu- patients, is the belief that doctors are their own analyses of the manufac-
al patients. The "authors" were paid not fooled or influenced by drug turer's data, thus ensuring that
an honorarium of $1,000 to lend their company promotional ploys such as approval decisions are based on
names to these articles, and also were gifts to attend medical meetings or valid data. Also, the agency has
able to claim publication credit on expensive meals. The evidence pre- authority to inspect clinical sites in
their professional resumes. sented in the court documents unam- order to keep investigators honest.
biguously shows that such schemes On the other hand, the editor of a
Speakers' Bureau work. Congress recognized 40 years peer reviewed medical journal must
Parke-Davis also formed a ago that a large proportion of physi- accept the veracity of a study submit-
Speakers' Bureau, another tactic to cians in everyday practice have nei- ted for publication. The editor will
make large and numerous payments ther the training nor the background send the study to several peer review-
to doctors who recommended to differentiate between a useful drug ers for their recommendations, but
gabapentin at teleconferences, din- and a harmful one. This is why these people have other things to do,
ner meetings, consultants meetings, Congress created a process by which and may spend only a few hours on
educational seminars, and other the FDA approves drugs based on their review. Peer reviewers also must
events. These speakers repeatedly validated science-to protect patients accept the veracity of the underlying
gave short presentations relating to from worthless or dangerous drugs. data presented in the study. The jour-
gabapentin for which they were paid But this says nothing about the nal editor has neither the authority
anywhere from $250 to $3,000. Some apparently substantial number of nor the resources to inspect clinical
speakers received tens of thousands doctors who accepted kickbacks or sites. This is a system that can be
of dollars annually in exchange for bribes to prescribe gabapentin for "gamed," as documented in the court
recommending to fellow physicians uses that had not been proven. The papers about Parke-Davis' gabapentin
that gabapentin be prescribed, par- memorable words of the inspector publication strategy.
ticularly for off-label uses. Speakers in the movie Casablanca-''I am The message for patients is that if
who most zealously advocated shocked-shocked!" come to mind. you have been prescribed a drug for
gabapentin were hired most fre- Second, the sacrosanct position of an off-label use, the evidence sup-
quently for speaking events, regard- peer-reviewed medical literature as a porting such a use may be good or it
less of the fact that many of these vehicle for scientific exchange has may be fabricated. The doctor pre-
events were billed as independent been seriously damaged. The manip- scribing the drug may have based the
medical education seminars where ulation of information about decision to use the drug on an
objective information was supposed gabapentin that Parke-Davis exer- expensive dinner, received a kick-
to be delivered. cised would astonish George Orwell. back or was bribed, or was simply
Circumstantial and some direct In defense of the many physicians fooled by a fabricated medical jour-
evidence over the years suggests that who try their best for patients by dili- nal article.
the behavior of Parke-Davis in the gently keeping up with the medical
off-label promotion of gabapentin is literature, there is no way for a doc- What You Can Do
not isolated, but rather an integral tor, scientist, or medical journal edi- If you or a family member receive
part of the pharmaceutical industry's tor to know if a study is a fabrication . gabapentin for a use not listed in the
marketing practices. However, in the There are major differences FDA approved professional product
Health Research Group's experience, between the way the FDA reviews labeling, discuss with your doctor
the gabapentin episode is the most clinical trials as part of the new drug the continued need for taking
complete and well documented case approval process and the process gabapentin.
of off-label promotion to ever come used by a peer reviewed medical

Public Citizen's Health Research Group + Health Letter + 5

 Product Recalls
july 1 0-August 7, 2002

T his chart includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs, dietary
supplements and medical devices, and Consumer Product Safety Commission (CPSC) recalls of consumer products.

DRUGS AND DIETARY SUPPLEMENTS

The recalls noted here reflect actions taken by a firm to remove a product from the market. Recalls may be conduct-
ed on a firm's own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall is a situation
in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health
consequences or death. Class II recalls may cause temporary or medically reversible adverse health consequences. A
Class III situation is not likely to cause adverse health effects. If you have any of the drugs noted here, label them Do
Not Use and put them in a secure place until you can return them to the place of purchase for a full refund. You can
also contact the manufacturer. If you want to report an adverse drug reaction to the FDA, call (800) FDA-1088. The
FDA web site is wwwfda.gov.

Class I Recall
Name of Drug or Supplement; Clas.~ of Reca/~· Problem Lot #; Qmmtity and Distribution; Mtlmtjacturer

Comblvlr Tablets (lamivudine 150 mg/zidovudine 300 mg) 60 Lots 1ZP0848, 1ZP2346, 1ZP2347; 1.756 bottles distributed in
tablet bottles; Counterfeit: bottles labeled to contain Combivir Illinois, California, Indiana, New York, Tennessee, Pennsylvania,
tablets may contain Ziagen tablets Maryland and New Jersey; Alliance Wholesale Distributor, Richton
Park, Illinois

Nmue of Drug m· Supplement; Clas.~ of Recall; Pmblem Lot #; Quantity allfl Di.~t,·ilmtitm; Mmuifacturer

Acyclovir Tablets, 400 mg, Rx only, 100-count bottles; Class Ill; Lot 106091 A EXP 3/04; 11,483 bottles distributed nationwide; lvax
Tablet crumbling Pharmaceuticals, Inc., Miami, Florida

Col rex Compound Capsules, 100 capsule bottles, Rx only, Lot H000449A; 1,853 bottles distributed in New Jersey; Mikart, Inc.,
(Codeine Phosphate 16 mg, Acetaminophen 325 mg, Phenylephrine Atlanta, Georgia
Hydrochloride 10 mg, Chlorpheniramine Maleate 2 mg); Class Ill;
Low weight capsules

Desyrel Tablets (trazodone HCL), 100 mg, Rx only, packaged in Lots MLS08 and MKC09; Undetermined quantity distributed nation-
bottles of 100 and 1,000 tablets; Class Ill; Lack of content uniformi- wide; Bristol-Myers Squibb Co., Evansville, Indiana
ty-subpotent at 18 month stability

Esgic-Pius Capsules (Butalbital, Acetaminophen and Caffeine Lots D01 0201 A, D01 0202A, D01 0203B, J01 0602A, J01 0603B and
Capsules) 50 mg/500 mg/40 mg, 100 and 500 count bottles, Rx only; L010742A; 966/500 ct. bottles and 23,081/100 ct. bottles distributed
Class Ill; Low weight dosage units in Missouri; Mikart, Inc., Atlanta, Georgia

Luvox Tablets (Fiuvoxamine Maleate) (scored), 25 mg, 50 mg and Numerous lots; 1,503,114 units distributed nationwide; Solvay
100 mg 100 count bottles and unit dose packages of 100, Rx only; Pharmaceuticals, Inc., Marietta, Georgia
Class Ill; Inaccuracies in data submitted to the New Drug Application
by Solvay (stability)

6 + September 2002
 MEDICAL DEVICES
Device recalls are classified in a manner similar to drugs, Class I, II or III, depending on the seriousness of the risk pre-
sented by leaving the device on the market. Contact the company for more information. You can also call the FDA's
Device Recall and Notification Office at (301) 443-4190. To report a problem with a medical device, call 1-800-FDA-
1088. The FDA web site is http.//wwwfda.gov.

Class I Recall
Nm11e of Device; Cltus of Reet1l~· Problem Lot #; Quautity ami Distributiou; Mtmufucturer

LTV Series Ventilators; Capacitor malfunction leading to quit LTV 1000, Catalog No. 10130. LTV 950, Cat. No. 10950. LTV 900,
with no alarm Cat. No. 10638. LTV 800, Cat. No. 11800; 3,348 distributed nation-
wide and internationally; Pulmonetic Systems, Inc., Colton,
California

Nm11e of Device; Class of Reetll~· Problem Lot #,· Qmmtity mul Di.~tributio11; Mmmfacturer

Contact Lens, Choice A.B. (aberation blocking) Daily wear soft Lots 0620, 1016, 1009, 0912,0924, 0925, 0926, 1025, 1004, 0926,
(hydrophilic); Class Ill; Polymer was undercured, lens may appear 1015,0829,0912,1023,0912,0921 , 0717,0916,10620,11025,
cloudy 10823, 10730; 781 units distributed nationwide; Specialty Ultravision,
St. Hubert, Quebec, Canada. Recalled by Ciba Vision Corp., Duluth,
Georgia

Disposable Syringe Kits; Class II; May exceed endotoxin specifica- Ct Tri Pak Sterile, catalog number CTP-200-FLS Lots 29764, 29765,
tion limits and 29766; 41 ,650 kits distributed nationwide and internationally;
Medrad, Inc., Indianola, Pennsylvania

CONSUMER PRODUCTS
Contact the Consumer Product Safety Commission (CPSC) for specific instructions or return the item to the place of
purchase for a refund. For additional information from the Consumer Product Safety Commission, call their hotline at
1-800-638-2772. The CPSC web site is www.cpsc.gov.

Name of Product; Problem Lot #; Quatltity tllltl Distrilmtio11; Mmmfacturer

All-Terrain Vehicles (ATVs); Mounting-bracket weld on rear hub Warrior model, years 1997 and 1998; 14,000 sold nationwide from
can come loose, resulting in rear brake failure August 1996 through December 1997; Yamaha Motor Corporation,
U.S.A., Cypress, California (800) 88-YAMAHA www.yamaha-
motor.com

Bicycle Suspension Seat Posts; Cradle, which attaches to the Thudbuster, black and silver with serial numbers ranging between
bicycle seat, can break, posing the risk of falls and serious injury 10894 and 18710; 7,700 sold nationwide from November 2000
through June 2002; Cane Creek Cycling Components, Fletcher, North
Carolina (800) 234-2725 www.canecreek.com

Cigarette Lighters; Lighters do not have child-resistant mecha- Shape of Coca-Cola and Budweiser beverage containers; 1,800 sold
nisms, as required by federal law in Oregon and Washington from October 2001 through February
2002; Young's J.K. Inc., Portland, Oregon (503) 252-3022

Dive Computer Consoles; Pressure gauge can malfunction and U-Line, Smart PRO, Pro ULTRA, Sport PLUS; 1, 700 sold nationwide
display inaccurate pressure readings. Divers could fail to decompress from January through May 2002; Johnson Outdoors Inc., Racine,
properly during a dive Wisconsin (800) 382-2211 www.scubapro.com

Public Citizen's Health Research Group + Health Letter + 7

 C 0 N S U M E R P R 0 D U C T S co,t.

Name of Product; Problem Lot #; Qutmtity a11d Di~·tributio11,· Mmmfacturer

Electrical Testing Meters; An incompatible grommet, located in Models CM-700 and CM-750; 650 sold nationwide during April2002;
battery compartment can cause meter to provide inaccurate voltage Greenlee Textron, Inc., Rockford, Illinois (800) 435-0786
and current readings, creating potential for electric shock or electrocu- www.greenlee.textron.com
tion

Extension Cords; Cords have undersized wires, presenting a shock Brown or white, 5-feet 3-inches long; 190,000 sold at discount stores
hazard nationwide from October 1998 through March 2002; STK International
Inc., Los Angeles, California (800) 536-7855

Gas Grills; Glass casing of thermometer displays attached to grills Series models 2000 and 3000; 1,800 sold in southeastern and south
can break or shatter central U.S. and on firm's web site from July 1999 through July 2002;
Flat Rock Grill Co., Powhatan, Virginia (888) 308-7399
www.flatrockgrill.com

Grass Bag Attachments; Rear-mounted grass bag does not seal Attachments for 19-inch electric walk-behind mowers; 5,000 sold
properly to the rear door of mower, allowing grass and other debris to nationwide from January through July 2002; MTD Products Inc.,
be thrown out at the top of the bag, creating a potential injury hazard Cleveland, Ohio (888) 848-6038

Juice Extractors or Juicers; Filter and lid can break apart and Model ACJ-250; 117,000 sold nationwide from March 1996 through
project metal and plastic into the air July 2002; Aroma Housewares Co., San Diego, California
(800) 276-6286

Mosquito Deletom Traps; Propane regulator can leak propane or Sold as part of the Portable and Back Home Systems, 24-inches high
allow an overflow posing a fire hazard with green or gray base; 136,000 sold nationwide from March through
July 2002; The Coleman Company Inc., Wichita, Kansas
(800) 257-5299 www.coleman.com

Pull-along Snails; Eyes on pull toy can detach, posing a choking Plan Toys, green, yellow and red wood, 10-inches long; 3,000 sold by
hazard internet retailers and mail order catalogs from June 2001through
June 2002; BRIO(r) Corp., Germantown, Wisconsin
(888) 274-6869

Riding Lawn Mowers; Excessive heat, vibrations and wear causes Hustler "FasTrak"; 1,500 sold nationwide from November 2001
the fuel line to droop over time and rub against the transmission fan, through May 2002; Excel Industries Inc., Hesston, Kansas
causing the fuel line to be cut, posing afire hazard (800) 395-4757 www.excelhustler.com

Smatter Spray Foam; If the pressurized can is left in a hot automo- Date codes 0492PT to 0952PT, sold in 3 varieties; 296,000 cans sold
bile, it can forcefully break apart and cause injury to a nearby con- nationwide from February through June 2002; Jakks Pacific Inc.,
sumer Malibu, California (800) 554-5516 www.jakkspacific.com

Sorter Toys; Plastic windows on the sorting blocks can break, caus- Sort & See wood box with shaped blocks; 880 sold nationwide from
ing beads to be released, presenting a choking hazard May through June 2002; Small World Toys, Culver City, California
(800) 421-4153

Toddler Puzzles; Dog puzzle included with both products and the Toddler Tote activity sets and Familiar Things puzzles; 121,000 sold
rubber handle on the box of the activity set can tear apart into small nationwide from January 1999 through July 2002; Lauri Inc., Phillips-
pieces and pose a choking hazard Avon, Maine (800) 451-0520

Toy Cars; Child can pull the horn from the steering wheel-small Model 8 Roadster, manufactured before January 2002; 59,000 sold
part poses a choking hazard nationwide from January 2001 through July 2002; Radio Flyer Inc.,
Chicago, Illinois (800) 708-9246 www.radioflyer.com

continued on page 9

8 + September 2002
 Pressure On To Ban Ephedra
This story is reprinted from a tran- thought it was safe. But a growing screened by the FDA before they're
script of an August 13, 2002 broad- chorus of critics claims ephedra is put on the market. And the proof
cast on the CBS Evening News. not safe. required to force them off the market
Also called "Ma huang," ephedra is much higher than what's necessary
lso called "Ma huang, " is banned by the Olympics commit- to ban a dangerous drug.

A ephedra is banned by the

O lympics committee, the NFL
and the NCAA. The U.S. military has
tee, the NFL and the NCAA. The U.S.
military has recorded injuries and
deaths in troops that took ephedra.
The ephedra industry says its own
scientific studies show the herb is
completely safe. "Consumers should
recorded injuries and deaths in Yet it remains wildly popular. The understand that if there were any sci-
troops that took ephedra. industry brags three billion servings ence indicating that the products
At age 35 Capt. Michael McDonald are consumed every year. were doing what some of the critics
was an up-and-coming Army pilot, That frustrates Raymond Woosley, claim they're doing, that the industry
and as far as anyone knew, the pic- a pharmacologist hired by the FDA would pull these products off the
ture of health. But, as CBS News in 1995 to analyze a rash of deaths market in a heartbeat," says Wes
Correspondent Sharyl Attkisson and heart problems in teenagers Siegner, of the Ephedra Education
reports, three years ago McDonald's who'd taken ephedra. "There's no Council.
military career came to a sudden In 2000, the FDA again tapped
halt. During physical training he col- Woosley to review 135 more cases,
lapsed. His heart stopped and res- this time mostly young women and
cuers shocked him back to life. "I
woke up in a hospital," he says. He
Herbal supplements athletes. "We saw the same thing, " he
says . "People were dying. People
didn't even recognize his own wife.
"We laughed because he tapped
are officially were having heart attacks, strokes
that (they) shouldn't have."
his mother over his shoulder and
said, 'Who's that pretty girl over
classified as a food Despite the second analysis, the
FDA failed to act, in part, Woosley
there?" his wife Margaret remembers.
Today, he can't recall his own wed-
and not a drug says, under pressure from the pow-
erful ephedra industry. Now, the
ding day, and sometimes can't watchdog group Public Citizen is
remember from one minute to the demanding the FDA ban ephedra.
next. McDonald's collapse mystified The FDA has put off a decision until
doctors, but they soon honed in on doubt in my mind that these were at least fall 2002.
one factor. "The only thing he was being caused by the ephedra prod- No matter what the outcome,
really taking was Ripped Fuel," says ucts," Woosley says. After reporting McDonald blames ephedra for
Margaret. his findings to the FDA, Woosley grounding him from the career he's
McDonald is now suing the mak- thought the agency would move dreamed of since he was a kid .
ers of Ripped Fuel, one of dozens of quickly to restrict ephedra. But that McDonald says he will never fly
dietary supplements containing the didn't happen. again in the military. "My military
herb ephedra, a chemical cousin to Part of the problem is that herbal career was cut short, " he says.
speed. It's used to boost energy, supplements are officially classified Ironically cut short, he believes, by
build muscle or lose weight. as a food and not a drug-meaning an herbal supplement he thought
Because it's all-natural, McDonald they don't have to be proven safe or would give him an edge.

c 0 N s u M E R p R 0 D u c T s COlli.

Name of Product; Problem Lot #; Qmmtity tmd Di.~tribuiiou; Mtmujttcturer

Vacation Station™ Children's Cooler/chairs; Folding mecha- Purple or green aluminum; 27,000 given to guests at participating
nism can pose acrushing, cutting or severing hazard to consumers' Hilton, Doubletree and Hilton Garden Inn hotels from May through
fingers June 2002; Hilton Hotels Corporation, Beverly Hills, California
(877) 221-2424 www.hilton.com/families

Vinyl Post Kits; Cracks can develop near the base of the posts Royal Colonial pre-built rail system; 1,250 sold in mid-Atlantic region
which can allow the railing to collapse, potentially injuring people on from February through April 2002; Royal Outdoor Products,
the deck Woodbridge, Ontario, Canada (877) 467-6925 www.royaloutdoor.com

Public Citizen's Health Research Group+ Health Letter+ 9

 West Nile Virus Activity
United States,August 8-14, 2002, and Mississippi,July 1-August 14, 2002
The following information comes available data, the median age was 54
During 2002, a total of 156 human
from Morbidity and Mortality Weekly years (range: 3--94 years), and the
cases with laboratory evidence of recent
Report, a publication of the Federal dates of illness onset ranged from June
WNV infection have been reported from
Centers for Disease Control and 10 to August 13.
Louisiana (n=85), Mississippi (n=48),
Prevention (CDC) _In addition, 1,458 dead crows and
Texas (n=14), Alabama (n=three), Illinois
(n=two), Florida (n=one), Indiana 1,137 other dead birds with WNV

T
his report su mmarizes West (n=one), Massachusetts (n=one), andinfection were reported from 37 states,
Nile virus (WNV) surveill anc District of Columbia (n=one). Nine New York City, and the District of
data re ported to the CDC by deaths have been reported from Columbia (Figure 1); 139 WNV infec-
ArboNET and by states and other Louisiana (n=seven) and Mississippitions in horses have been reported
jurisdictions as of August 14, 2002. from 15 states (Alabama, Florida,
(n=two). Among the 154 patients with
Georgia, Illinois, Kansas,
United States Kentucky, Louisiana, Min-
During the reporting FIGURE 1. Areas reporting West Nile virus (WNU) activity- nesota, Mississippi, Nebraska,
period of August 8--14, a United States, 2002* North Dakota, Ohio, South
total of 44 laboratory-posi- Dakota, Tennessee, and
tive human cases of WNV- Texas). During 2002, WNV
associated illness were seroconversions have been
reported from Mississippi reported in 62 sentinel chick-
(n=20), Louisiana (n=14), en flocks from Florida,
Alabama (n=three), Texas Nebraska, and Pennsylvania;
(n=two), Florida (n=one), 787 WNV-positive mosquito
Illinois (n=one), Indiana pools have been reported
(n=one), Massachusetts from 13 states (Alabama,
(n=one), and the District of f"-1 - Georgia, Illinois, Indiana,
Columbia (n=one). During
the same period, WNV
~""'t> Massachusetts, Mississippi,
Nebraska, New Jersey, Ohio,
infections were reported in Pennsylvania, South Dakota,
13} Recent human WNV Infection and animal WNV activity
382 dead crows, 310 other 1'5 Animal WNV activity only
Texas, and Virginia), New
dead birds, 52 horses, and York City, and the District of
• As ol August 14, 2002
362 mosquito pools. Columbia.

TilE PUBliC CTT1Zl!N Hl!Alnl RI!S'I!ARCH CROUP

Edttor ...........................................Stdney M. Wolfe

Managing Edttor .................. Phyllts McCarthy
Staff Researchers .......................... Larry Sastch
Hcaltl1 Letter The Health Research Group was co-founded
in 1971 by Ralph Nader and Sidney Wolfe in
Washington, D.C. to fight for the public's
health, and to give consumers more control
Benita Marcus Adler over decisions that affect their health.
Information Spectaltst......]ohn Paul Fawcett Copyright © Health Letter, 2002
Published Monthly by Material in the Health Leifer may not be
Production Mg1: ...................... Krtsty !.jackson Public Citizen Health Research Group re-printed without permission from the Editor.
All rights reserved. ISSN 0882-598X Send letters and requests to HEALTH LEITER,
Editor, 1600 20th St., N\V, Washington, D.C.,
President ....................................joan Claybrook 20009.
Founder ........................................... Ralph Nader
Annual subscription price is $18.00 (12 is-
sues). Mail subscriptions and address changes
to Health Letter, Circulation Department, 1600
20th St., NW, Washington, D.C., 20009.
Our Web site address is www.citizc:n.org/hrg

10 + September 2002
OUTRAGE, from page 12 access to these AERs." The DO] 2001.
documented each call received from underscored the urgency of the July The lawyer who approached you,
a consumer. 1 request by referring to the five year Jeff Wentworth, is, according to a May
In order to see if Ellis' allegation statute of limitations that exists 15, 2000 article in Time Magazine,
was supportable and as an important between the commission of an from a San Antonio law firm headed
source of data on the safety of these alleged crime and the filing of papers by some of President Bush's closest
products, the FDA subsequently concerning criminal prosecution. political associates and was hired by
asked the Department of justice "to "The statute of limitations for this Metabolife when Bush was governor
obtain the consumer adverse reac- crime is five years. Any such charges of Texas in order to influence the reg-
tion reports (AERs) documented by would have to be brought before ulation of ephedra by the Texas State
Metabolife." Previous efforts by the 4/17/03 [five years after the letter Health Department.
DO] to obtain these reports, filed by from Ellis to the FDA]." As you are aware, we petitioned
Metabolife under a gag order in a HHS to ban the manufacture and sale
California state court ephedra injury Previous Michael Ellis Criminal of all ephedra containing dietary
case, were thwarted because the Record supplements last September. By
judge refused the DO] request Metabolife President and co- now, there have been well over 100
because of the secrecy under which founder Michael Ellis was convicted deaths reported to the FDA in people
the documents were obtained during in 1990 on a drug-related charge using ephedra containing products
discovery from Metabolife in that involving the illegal manufacture and and, as described in our September
case. The DO] subsequently learned sale of methamphetamine which, 5, 2001, petition to ban these prod-
from an attorney, according to the interestingly, can be produced from ucts, there are more reports of death,
july 1 letter to Dan Troy, that in yet ephedra. He pleaded guilty to a stroke, arrhythmia, heart attacks,
another product liability case against felony charge. chest pain, seizures and hyperten-
Metabolife, the company had sion for ephedra than for all other
"received consumer reports of seri- Metabolife Political Influence dietary supplements combined. As
ous injuries related to the use of According to an article in The long as the FDA delays the inevitable
Metabolife before Ellis wrote his Washington Post (December 25, ban of these products, cases will
April 17, 1998 letter to FDA claiming 2000), Metabolife had, by October 1, continue to occur.
that Metabolife had received no such 2000, donated $683,000 to federal I urge you to free yourself from
reports." This is presumably the basis campaigns, ranking seventh among the influences that Metabolife and
for DO]'s allegation that Ellis may all pharmaceutical companies nation- other ephedra makers have had on
have made false statements to FDA wide. In Texas, the site of a battle the Texas Department of Health and
and "thereby, if done willfully, he between ephedra makers and the their continued massive lobbying in
may have committed a Federal state health department efforts to Washington against a ban of these
crime." more tightly regulate the dietary sup- most dangerous "food supplements."
The DO] letter goes on to state plement, Metabolife spent more than Any failure by your department to: a)
that "While we were unsuccessful in $4 million between 1998 and 2000 to agree to aggressively pursue a crimi-
getting access to the AERS in the lobby against state regulations. In nal investigation against Metabolife
California state court, Federal law is California, Metabolife ranked fourth President Michael Ellis for apparently
much more favorable to granting in state "soft money" contributions, lying to the government; b) to pur-
access to discovery materials when with $493,000 in 2000 and a $100,000 sue the acquisition of now-sealed
access to those materials will benefit donation to the campaign of Gov. court documents concerning serious
the public health and safety. Gaining Gray Davis, who subsequently adverse effects of Metabolife, many
access to these AERs will not only vetoed state legislation imposing likely not to have been reported to
give FDA a substantial amount of restrictions on ephedra use. the FDA because there is no require-
data with which to study the safety of More recently, the Los Angeles ment to do so; and c) to order a ban
ephedrine-based dietary supple- Times (September 6, 2001) reported on the production and distribution of
ments, it will also permit FDA and on the role of the current Bush ephedra products will ultimately
our office to assess the accuracy of Administration in suspending enforce- bring disgrace to you and your
Ellis' 4/17/98 letter to FDA and any ment of a Texas regulation to protect department.
potential criminal liability Ellis may athletes and other users of dietary
have for writing that letter. Asking supplements such as ephedra. This 1be evening this letter was
the Alabama court for access to the occurred, according to the L4 Times, sent, the Department of justice
Metabolife AERS will only require the after telephone calls to Austin, Texas, announced they are starting an
filing of a motion with the court. My from one of your senior aides after investigation into these charges.
office stands ready to handle making you were approached by a lawyer
such a request if FDA wishes to seek representing Metabolife in August

Public Citizen's Health Research Group + Health Letter + 11

 OUTRAGE OF THE MONTH

Health Research Group Asks for Metabolite President

to be Investigated
Th is letter was sent by Health Letter ly, he may have committed a Federal of Metabolife, wrote a letter to the
Editor Dr. Sidney M. Wolfe to crime, violating 18USC§ 1001 and FDA dated April 17, 1998, in whi ch
Tommy Thompson, Secretary of the 1505." The DO] lette r therefore asks if he contended that ephedrine w as
Depa rtment of Health and I Iuman "FDA w o uld like our office to begin being used safely and that there was
Services (HHS) on August 15. investigating this matter. " The other no widespread pattern of abuse of
request to the FDA in the le tter is to ephedrine in the U.S. or the world.

T
his letter strongly urges you to agree that the D O] be given the go- To support these contentions, Ellis
direct FDA Chief Counsel Dan ahead to try to obtain a large number stated in his letter that "Metabolife
Troy to agree that a criminal of adverse reaction reports of people has never received one notice from a
investigation of Metabolife be using Metabolife, o btained by plain- consumer that any serious adverse
opened, as requested in a July 1, tiffs' atto rneys during discovery from health event has occurred because of
2002, letter he was sent from Eugene the company, which are currently the ingestion of Metabolife 356 [a
M. Thirolf, Director, Office of under a gag order in a product liabil- best selling ephedra-containing diet
Co nsumer Litigation, U.S. Department ity case pending in Federal court in product]." Ellis also stated that "con-
of justice (DOJ). In that letter, the DO] Alabama. sequently, since there had been no
official states that Michael Ellis, the In a March 18, 1998, Federal serious adverse reports [AERs] of any
President of Metabolife, one of the Register Notice, the FDA asked for sort, there had been no such reports
natio n 's largest producers of comme nts conce rning the abuse of overuse or abuse of the product. "
ephedrine-based dietary supplements, potential, actual abuse, medical use- Ellis described Metabolife's monitor-
may have made false statements to fulness and trafficking of ephedrine . ing system, including how Metabolife
the FDA and "thereby, if done willful- In respo nse, Michael Ellis , President continued on page 11

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12 + September 2002