Abstract
Summary
This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry.
Introduction
Real or perceived problems in the relationship between academics and the industry have been the subject of much recent debate. It has been suggested that academic clinicians should sever all links with the industry—a view that is rarely challenged.
Methods
Academic experts and members of the pharmaceutical industry were invited to an expert consensus meeting to debate this topic. This meeting was organized by the Group for the Respect of Ethics and Excellence in Science. Conflict of interest, competing interest, right and duties of academic scientist, authorship, and staff and student education were discussed.
Results
Guidelines for a transparent, ethical, strong, and successful partnership between the academic scientist and the pharmaceutical industry have been provided.
Conclusions
The Group support interactions between the industry and clinicians provided that it is transparent and ethical.
Similar content being viewed by others
Explore related subjects
Discover the latest articles, news and stories from top researchers in related subjects.References
Walsh K, Sandars J (2008) Competing interests and research in medical education. Postgrad Med J 84:113–114
Haines IE, Olver IN (2008) Are self-regulation and declaration of conflict of interest still the benchmark for relationships between physicians and industry? Med J Aust 189:263–266
Shaldon S (2008) Conflict of interest in clinical guidelines should be avoided. Nephrol Dial Transplant 23:1771, author reply 1772
Elliott KC (2008) Scientific judgment and the limits of conflict-of-interest policies. Account Res 15:1–29
Sismondo S (2008) How pharmaceutical industry funding affects trial outcomes: causal structures and responses. Soc Sci Med 66:1909–1914
Doucet M, Sismondo S (2008) Evaluating solutions to sponsorship bias. J Med Ethics 34:627–630
Chabner BA (2008) Conflict of interest: in the eye of the beholder? Oncologist 13:212–213
Camilleri M, Cortese DA (2007) Managing conflict of interest in clinical practice. Mayo Clin Proc 82:607–614
Tungaraza T, Poole R (2007) Influence of drug company authorship and sponsorship on drug trial outcomes. Br J Psychiatry 191:82–83
Duvall DG (2006) Conflict of interest or ideological divide: the need for ongoing collaboration between physicians and industry. Curr Med Res Opin 22:1807–1812
Weinfurt KP, Friedman JY, Dinan MA, Allsbrook JS, Hall MA, Dhillon JK, Sugarman J (2006) Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators. J Law Med Ethics 34(581–591):481
Bekelman JE, Li Y, Gross CP (2003) Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 289:454–465
Shaywitz D, Stossel T (2009) It’s time to fight the “PharmaScolds”. In Wall Street Journal
Collier J (2009) Doctors, patients, and the pharmaceutical industry. BMJ 338:b443
Royal-College-of-Physicians (2009) Innovating for health: patient, physicians, the pharmaceutical industry and the NHS. Report of a Working Party, London
Rothman DJ, McDonald WJ, Berkowitz CD, Chimonas SC, DeAngelis CD, Hale RW, Nissen SE, Osborn JE, Scully JH Jr, Thomson GE, Wofsy D (2009) Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA 301:1367–1372
Christensen JA, Orlowski JP (2005) Bounty-hunting and finder’s fees. IRB 27:16–19
Moses H 3rd, Dorsey ER, Matheson DH, Thier SO (2005) Financial anatomy of biomedical research. JAMA 294:1333–1342
Olesen J, Lekander I, Andlin-Sobocki P, Jonsson B (2007) Funding of headache research in Europe. Cephalalgia 27:995–999
Philipson L (2005) Medical research activities, funding, and creativity in Europe: comparison with research in the United States. JAMA 294:1394–1398
Demotes-Mainard J, Canet E, Segard L (2006) Public–private partnership models in France and in Europe. Therapie 61(325–334):313–323
Moses H 3rd, Braunwald E, Martin JB, Thier SO (2002) Collaborating with industry—choices for the academic medical center. N Engl J Med 347:1371–1375
Bero LA, Glantz S, Hong MK (2005) The limits of competing interest disclosures. Tob Control 14:118–126
Sismondo S (2008) Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemp Clin Trials 29:109–113
Niebyl JR (2008) The pharmaceutical industry: friend or foe? Am J Obstet Gynecol 198:435–439
Haas J (2008) Commentary: epidemiology and the pharmaceutical industry: an inside perspective. Int J Epidemiol 37:53–55, discussion 65-58
Boyd EA, Bero LA (2007) Defining financial conflicts and managing research relationships: an analysis of university conflict of interest committee decisions. Sci Eng Ethics 13:415–435
Sismondo S (2007) Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med 4:e286
Reginster JY (2007) The efficacy of glucosamine sulfate in osteoarthritis: financial and nonfinancial conflict of interest. Arthritis Rheum 56:2105–2110
Pharmaceutical Research and Manufacturers of America (PhRMA) (2008) Code on interactions with healthcare professionals
Wager E, Field EA, Grossman L (2003) Good publication practice for pharmaceutical companies. Curr Med Res Opin 19:149–154
Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark DB, Califf RM (2002) A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med 347:1335–1341
Campbell P (2001) Declaration of financial interests. Nature 412:751
Wager E (2004) The need for trial identifiers. Curr Med Res Opin 20:203–206
Hirsch L (2008) Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors. Curr Med Res Opin 24:1683–1689
Goldhahn J, Mitlak B, Aspenberg P, Kanis JA, Rizzoli R, Reginster JY (2008) Critical issues in translational and clinical research for the study of new technologies to enhance bone repair. J Bone Jt Surg Am 90(Suppl 1):43–47
Compston J, Reid DM, Boisdron J, Brandi ML, Burlet N, Cahall D, Delmas PD, Dere W, Devogelaer JP, Fitzpatrick LA, Flamion B, Goel N, Korte S, Laslop A, Mitlak B, Ormarsdottir S, Ringe J, Rizzoli R, Tsouderos Y, Van Staa T, Reginster JY (2008) Recommendations for the registration of agents for prevention and treatment of glucocorticoid-induced osteoporosis: an update from the Group for the Respect of Ethics and Excellence in Science. Osteoporos Int 19:1247–1250
Lekkerkerker F, Kanis JA, Alsayed N, Bouvenot G, Burlet N, Cahall D, Chines A, Delmas P, Dreiser RL, Ethgen D, Hughes N, Kaufman JM, Korte S, Kreutz G, Laslop A, Mitlak B, Rabenda V, Rizzoli R, Santora A, Schimmer R, Tsouderos Y, Viethel P, Reginster JY (2007) Adherence to treatment of osteoporosis: a need for study. Osteoporos Int 18:1311–1317
Reginster JY, Abadie E, Delmas P, Rizzoli R, Dere W, der Auwera P, Avouac B, Brandi ML, Daifotis A, Diez-Perez A, Calvo G, Johnell O, Kaufman JM, Kreutz G, Laslop A, Lekkerkerker F, Mitlak B, Nilsson P, Orloff J, Smillie M, Taylor A, Tsouderos Y, Ethgen D, Flamion B (2006) Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men. Osteoporos Int 17:1–7
Abadie E, Ethgen D, Avouac B, Bouvenot G, Branco J, Bruyere O, Calvo G, Devogelaer JP, Dreiser RL, Herrero-Beaumont G, Kahan A, Kreutz G, Laslop A, Lemmel EM, Nuki G, Van De Putte L, Vanhaelst L, Reginster JY (2004) Recommendations for the use of new methods to assess the efficacy of disease-modifying drugs in the treatment of osteoarthritis. Osteoarthritis Cartilage 12:263–268
Holgate ST, Bousquet J, Chung KF, Bisgaard H, Pauwels R, Fabbri L, Rabe K, Doherty M, Snell NJ, Cuss F, D’Amato M, Reginster JY (2004) Summary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma. Respir Med 98:479–487
Delmas PD, Calvo G, Boers M, Abadie E, Avouac B, Kahan A, Kaufman JM, Laslop A, Lekkerkerker JF, Nilsson P, Van Zwieten-Boot B, Kreutz G, Reginster JY (2002) The use of placebo-controlled and non-inferiority trials for the evaluation of new drugs in the treatment of postmenopausal osteoporosis. Osteoporos Int 13:1–5
Vignon E, Garnero P, Delmas P, Avouac B, Bettica P, Boers M, Ehrich E, MacKillop N, Rovati L, Serni U, Spector T, Reginster JY (2001) Recommendations for the registration of drugs used in the treatment of osteoarthritis: an update on biochemical markers. Osteoarthritis Cartilage 9:289–293
Group for the Respect of Ethics and Excellence in Science (GREES) (1998) Recommendations for the registration of drugs used in the treatment of rheumatoid arthritis: rheumatoid arthritis section. Br J Rheumatol 37:211–215
Kanis JA, Johnell O, Oden A, Johansson H, De Laet C, Eisman JA, Fujiwara S, Kroger H, McCloskey EV, Mellstrom D, Melton LJ, Pols H, Reeve J, Silman A, Tenenhouse A (2005) Smoking and fracture risk: a meta-analysis. Osteoporos Int 16:155–162
Horrobin DF (1999) Beyond conflict of interest. Non-financial conflicts of interest are more serious than financial conflicts. BMJ 318:466
The PLoS Medicine Editors (2008) Making sense of non-financial competing interests. PLoS Med 5:e199
Bero L (2008) “Experimental” institutional models for corporate funding of academic research: unknown effects on the research enterprise. J Clin Epidemiol 61:629–633
de Haas ER, de Vijlder HC, van Reesema WS, van Everdingen JJ, Neumann HA (2007) Quality of clinical practice guidelines in dermatological oncology. J Eur Acad Dermatol Venereol 21:1193–1198
Reed DA, Cook DA, Beckman TJ, Levine RB, Kern DE, Wright SM (2007) Association between funding and quality of published medical education research. JAMA 298:1002–1009
Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326:1167–1170
Angell M, Kassirer JP (1996) Editorials and conflicts of interest. N Engl J Med 335:1055–1056
Drazen JM, Curfman GD (2002) Financial associations of authors. N Engl J Med 346:1901–1902
Ancker JS, Flanagin A (2007) A comparison of conflict of interest policies at peer-reviewed journals in different scientific disciplines. Sci Eng Ethics 13:147–157
Chaudhry S, Schroter S, Smith R, Morris J (2002) Does declaration of competing interests affect readers’ perceptions? A randomised trial. BMJ 325:1391–1392
Healy D, Cattell D (2003) Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry 183:22–27
McLennan M, Leong FC, Steele A, Harris J (2008) The influence of industry sponsorship on the acceptance of abstracts and their publication. Am J Obstet Gynecol 198(579):e571–e574
Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, Horton R, Kotzin S, Nicholls MG, Nylenna M, Overbeke AJ, Sox HC, Van Der Weyden MB, Wilkes MS (2001) Sponsorship, authorship, and accountability. Lancet 358:854–856
Bodenheimer T (2000) Uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med 342:1539–1544
International Committee of Medical Journal Editors (1997) Uniform requirements for manuscripts submitted to biomedical journals. JAMA 277:927–934
Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM, Field EA, Gurr JA, Marx ME, Patel M, Sanes-Miller C, Yarker YE (2009) Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 339:b4330
Jacobs A, Wager E (2005) European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 21:317–322
Norris R, Bowman A, Fagan JM, Gallagher ER, Geraci AB, Gertel A, Hirsch L, Ross PD, Stossel TP, Veitch K, Woods D (2007) International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer. Curr Med Res Opin 23:1837–1840
Moher D, Schulz KF, Altman D (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285:1987–1991
Acknowledgements and competing interests
The GREES is a nonprofit organization, which has no source of funding, outside the annual dues (€1 per year) of the individual members. GREES only serves as a go-between to facilitate the organization of scientific meetings including academic scientists, members of regulatory agencies, and representatives of the pharmaceutical industry. O Bruyere receives grants, fees or has been reimbursed for attending meetings from MSD, GlaxoSmithKline, Rottapharm, Servier, Theramex, Galapagos, Wyeth, and IBSA. He also gives advice, as an expert, to the European Food Safety Authority, the French Food Safety Agency, and the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis. JA Kanis consults for a large number of companies: Abiogen, Italy; Amgen, USA, Switzerland, and Belgium; Bayer, Germany; Besins-Iscovesco, France; Biosintetica, Brazil; Boehringer Ingelheim, UK; Celtrix, USA; D3A, France; European Federation of Pharmaceutical Industry and Associations (EFPIA), Brussels; Gador, Argentina; General Electric, USA; GSK, UK and USA; Hologic, Belgium and USA; Kissei, Japan; Leiras, Finland; Leo Pharma, Denmark; Lilly, USA, Canada, Japan, Australia, and UK; Merck Research Labs, USA; Merlin Ventures, UK; MRL, China; Novartis, Switzerland and USA; Novo Nordisk, Denmark; Nycomed, Norway; Ono, UK and Japan; Organon, Holland; Parke-Davis, USA; Pfizer, USA; Pharmexa, Denmark; Procter and Gamble, UK and USA; ProStrakan, UK; Roche, Germany, Australia, Switzerland, and USA; Rotta Research, Italy; Sanofi-Aventis, USA; Schering, Germany and Finland; Servier, France and UK; Shire, UK; Solvay, France and Germany; Strathmann, Germany; Tarsa Therapeutics, USA; Tethys, USA; Teijin, Japan; Teva, Israel; UBS, Belgium; Unigene, USA; Warburg-Pincus, UK; Warner-Lambert, USA; and Wyeth, USA. He also receives grants or gives advice to nongovernmental agencies: Arthritis and Rheumatism Council, UK; Canadian Osteoporosis Society; European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO); Government of Manitoba, Canada; Group for the Respect of Ethics and Excellence in Science (GREES); INSERM, France; Medical Research Council, UK; Ministry of Public Health, China; Ministry of Health, Australia; National Institute for Health and Clinical Excellence (NICE), UK; National Osteoporosis Guideline Group, UK; National Osteoporosis Society; International Osteoporosis Foundation; Japanese Osteoporosis Society; National Osteoporosis Society, UK; Osteoporosis 2000, UK; Osteoporosis Australia; Swiss Osteoporosis Society; and World Health Organization (WHO), Geneva. N Alsayed is an employee of Sanofi-Pasteur MSD. ML Brandi receives support from Fondazione F.I.R.M.O. (Fondazione Italiana Ricerca Malattie Ossee) and grants from Merck Sharpe & Dohme, Nycomed, Roche, Glaxo, Eli Lilly, and Wyeth. She has acted as a speaker for Procter and Gamble, Merck Sharpe & Dohme, Nycomed, and Wyeth. D Cahall is an employee of Sanofi-Aventis and as such receives remuneration and owns stock in the company. A Chines is an employee of Wyeth Pharmaceuticals. J-P Devogelaer has received consulting or advisory board fees from Novartis; lecture fees from Merck, Sharpe & Dohme, Procter & Gamble, Servier, and Roche; and grant support from Schering-Plough, Abbott, Amgen, Novartis, Servier, Merck, Sharpe & Dohme, Procter & Gamble, and Fonds National de Recherche Scientifique Médicale Belge. W Dere is an employee of Amgen. N Goel is an employee of UCB Pharma. N Hughes was an employee of Amgen. JM Kaufman received fees as consultant, for participating in an advisory board, as a speaker, or as clinical trial investigator, or received financial support for attending meetings from Amgen, Eli Lilly, GlaxoSmithKline, Merck Sharpe & Dohme, Novartis, Novo Nordisk, Nycomed, Procter & Gamble, Roche, Sanofi-Aventis, Servier, and Wyeth. He received grant support from GlaxoSmithKline, Merck Sharpe & Dohme, Novartis, Roche, and the Flemish Fund for Scientific Research. He is a (alternate) member of a commission on drug reimbursement with the Belgian health authorities. S Korte is an employee of Novartis. BH Mitlak is an employee of Eli Lilly and Company. D. Niese is an employee of Novartis. R Rizzoli is at the Speaker Bureau of Amgen, GSK, Merck, Novartis, Nycomed, Roche, and Servier. He is a member of the Scientific Advisory Boards of Amgen, Danone, Eli Lilly, Novartis, Nycomed, Roche, and Servier; and editor of Bone and Associate Editor of Osteoporosis International. He is treasurer and member of the Executive Committee of the International Osteoporosis Foundation. L Rovati is an employee of Rottapharm. J-Y Reginster has received consulting fees or payments for participating in advisory boards for Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, and UCB. He has received lecture fees when speaking at the invitation of Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genevrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Theramex, Nycomed, and Novo Nordisk; and grant support from Bristol Myers Squibb, Merck Sharp & Dohme, Rottapharm, Teva, Lilly, Novartis, Roche, GlaxoSmithKline, Amgen, and Servier.
Contributions
All authors participated at the meeting. Initial literature review was performed by OB, MEIA, and SK. OB and JAK have written the first draft of the manuscript. All authors have commented on the initial manuscript and have approved the final manuscript.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Bruyere, O., Kanis, J.A., Ibar-Abadie, ME. et al. The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES). Osteoporos Int 21, 713–722 (2010). https://doi.org/10.1007/s00198-010-1190-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00198-010-1190-9