Abstract
Conflicts of interest are common and exist in academia, government, and many industries, including pharmaceutical development. Medical journal editors and others have recently criticized “the pharmaceutical industry,” citing concerns over investigator access to data, approaches to analysis of clinical trial data, and publication practices. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures, and markets a broad range of human and animal health products, directly and through its joint ventures. Although part of its mission is to provide a superior rate of return to its investors, Merck does not believe this creates an irreconcilable conflict of interest, particularly in activities concerning clinical drug development. We employ rigorous scientific methods to design, conduct, analyze, and report results of clinical trials in the development of innovative drugs and vaccines, with a focus on meeting unmet medical needs and with an ethic that puts the interests of the patient first. This article describes Merck’s approaches to potential conflicts of interest in drug development, particularly with regard to clinical trials. We believe that proprietary interests of the Company can be respected while observing objectivity and transparency in communicating clinical research results. The standards for the review of manuscripts reporting such trials for peer-reviewed publication should be the same, whether they are from Merck or elsewhere.
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Thompson, D.F. (1993) Understanding financial conflicts of interest. N Engl J Med 329: 573–576.
Smith, R. (1998) Beyond conflict of interest: transparency is the key. Br Med J 317: 291–292.
Cohen, J.J. (2001) Trust us to make a difference: ensuring public confidence in the integrity of clinical research. Acad Med 76: 209–214.
Horton, R. (1997) Conflicts of interest in clinical research: opprobrium or obsession? Lancet 349: 1112–1113.
Smith, R. (1994) Conflict of interest and the BMJ. Br Med J 308: 4–5.
Rennie, D. (1997) Thyroid storm. JAMA 277: 1238–1243.
Kahn, J.O., Cherng, D.W., Mayer, K., Murray, H., Lagakos, S. for the 806 Investigator Team. (2000) Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 × 106/L CD4 cell counts. JAMA 284: 2193–2202.
Hrachovec, J.B., Mora, M., Wright, J.M., Perry, T.L., Bassett, K.L., Chambers, G. K., Silverstein, F., Simon, L., Faich, G. (2001) Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 286: 2398–2400.
Loder, E. (2002) Sponsorship, authorship, and accountability (letter to the editor). N Engl J Med 346: 291.
Steneck, N.H. (2000) Assessing the integrity of publicly funded research — a background report for the November 2000 ORI Research Conference on Research Integrity. Accessed May 1, 2002, at http://www.ori.dhhs.gov/multimedia/acrobat/backg_int.pdf.
Weiss, R. B., Rifkin, R.M., Stewart, F.M., Theriault, R.L., Williams, L.A., Herman, A.A., Beveridge, R.A. (2000) High-dose chemotherapy for high-risk primary breast cancer: an on-site review of the Bezwoda study. Lancet 355: 999–1003.
Angell, M., Kassirer, J.P. (1994) Setting the record straight in the breast-cancer trials. N Engl J. Med 330: 1448–1450.
Kohn, A. (1986) False prophets: fraud and error in science and medicine. The brilliant John Darsee. Blackwell, Oxford, England: 84–88.
DiMasi, J.A. (2001) Risks in drug development: approval success rates for investigational drugs. Clin Pharmacol Ther 69: 297–307.
DiMasi, J. (2001) Tufts Center for the Study of Drug Development pegs cost of a new prescription medicine at $802 million. Press release Nov 30, 2001. Accessed May 15, 2002, at http://www.tufts.edu/med/csdd/Nov30CostStudyPressRelease.html.
Navia, M.A., Fitzgerald, P.M.D., McKeever, B.M., Leu, C.T., Heimbach, J.C., Herber, W.K., et al. (1989) Three-dimensional structure of aspartyl protease from human immunodeficiency virus HIV-1. Nature 337: 615–620.
DeAngelis, C.D., Fontanarosa, P.B., Flanagin, A. (2001) Reporting financial conflicts of interest and relationships between investigators and research sponsors. JAMA 286: 89–91.
Davidoff, F., DeAngelis, C.D., Drazen, J.M., Hoey, J., Højgaard, L., Horton, R., et al. (2001) Sponsorship, authorship, and accountability. N Engl J Med 345: 825–827.
Lewis, S., Baird, P., Evans, R.G., Ghali, W.A., Wright, C.J., Gibson, E., Baylis, F. (2001) Dancing with the porcupine: rules for governing the university-industry relationship. CMAJ 165: 783–785.
Weintraub, W.S., Boccuzzi, S.B., Klein, J.L., Kosinski, A.S., King III, S.B., Ivanhoe, R., et al. for the Lovastatin Restenosis Trial Study Group. (1994) Lack of effect of lovastatin on restenosis after coronary angioplasty. N Engl J Med 331: 1331–1337.
Pitt, B., Poole-Wilson, P.A., Segal, R., Martinez, F.A., Dickstein, K., Camm, A.J., et al. for the ELITE II Investigators. (2000) Effect of losartan compared to captopril on mortality in patients with symptomatic heart failure: randomised trial — the Losartan Heart Failure Survival Study ELITE II. Lancet 355: 1582–1587.
Topol, E.J., Moliterno D.J., Herrmann, H.C., Powers, E.R., Grines, C.L., Cohen, D.J. et al. for the TARGET Investigators. (2001) Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization. N Engl J Med 344: 1888–1894.
Navari, R.M., Reinhardt, R.R., Gralla, R.J., Kris, M.G., Hesketh, P.J., Khojasteh, A., et al. (1999) Reduction of cisplatin-induced emesis by a selective neurokinin-1-receptor antagonist. N Engl J Med 340: 190–195.
Dickersin, K., Chan, S., Chalmers, T.C., (1987) Publication bias and clinical trials. Controlled Clin Trials 8: 343–353.
Easterbrook, P.J., Berlin, J.A., Gopalan, R., Matthews, D.R. (1991) Publication bias in clinical research. Lancet 337: 867–872.
Blumenthal, D., Campbell, E.G., Anderson, M.S., Causino, N., Louis, K.S. (1997) Withholding research results in academic life science: evidence from a national survey of faculty. JAMA 277: 1224–1228.
Davidson, R.A. (1986) Source of funding and outcome of clinical trials. J Gen Int Med 1: 155–158.
Stelfox, H.T., Chua, G., O’Rourke, K., Detsky, A.S. (1998) Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 338: 101–106.
Van Kolfschooten, F. (2002) Conflicts of interest: can you believe what you read? Nature 416: 360–363.
Rennie, D., Flanagin, A. (1994) Authorship! Authorship! Guests, ghosts, grafters and the two-sided coin. JAMA 271: 469–471.
Flanagin, A., Carey, L.A., Fontanarosa, P.B., Phillips, S.G., Pace, B.P., Lundberg, G.D., and Rennie, D. (1998) Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA 280:222–224.
The CONSENSUS Trial Study Group. (1987) Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 316: 1429–1435.
Scandinavian Simvastatin Survival Study Group. (1994) Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study. Lancet 344: 1383–1389.
Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg MC et al for the FIT Research Group. (2000) Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. J Clin Endocrinol Metab 85: 4118–24. (Erratum J Clin Endocrinol Metab 2001 86: 938).
McConnell, J.D., Bruskewitz, R., Walsh, P., Andriole, G., Lieber, M., Holtgrewe, H.L., et al. for the Finasteride Long-Term Efficacy and Safety Study Group. (1998) The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N Engl J Med 338: 557–563.
Downs, J.R., Clearfield, M., Weis, S., Whitney, E., Shapiro, D.R., Beere, P.A., et al. For the AFCAPS/TexCAPS Research Group. (1998) Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels. JAMA 279: 1615–1622.
Bombardier, C., Laine, L., Reicin, A., Shapiro, D., Burgos-Vargas, R., Davis, B., et al. for the VIGOR Study Group. (2000) Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 343: 1520–1528.
Brenner, B.M., Cooper, M.E., De Zeeuw, D., Keane, W.F., Mitch, W.E., Parving, H-H., et al. for the RENAAL Study Investigators. (2001) Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 345: 861–869.
Dahlöf, B., Devereux, R.B., Kjeldsen, S., Julius, S., Beevers, G., de Faire, U., et al. for the LIFE Study Group. (2002) Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 359: 995–1003.
Juni, P., Rutjes, A. W.S., Dieppe, P. A. (2002) Are selective COX-2 inhibitors superior to traditional nonsteroidal anti-inflammatory drugs? Adequate analysis of the CLASS trial indicates that this may not be the case (editorial). Br Med J 324: 1287–1288.
Drazen, J.M. and Curfman, G.D. (2002) Financial associations of authors (editorial). N Engl J Med 346: 1901–1902.
Smith, R. (2001) Maintaining the integrity of the scientific record — editors make a move (editorial). Br Med J 323: 588.
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Based on presentations given April 5, 2002 at the International Bioethics Conference Warsaw, Poland and May 5, 2002 at the Annual Meeting of the Council of Science Editors, San Diego, California, USA.
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Hirsch, L.J. Conflicts of interest in drug development: The practices of Merck & Co., Inc.. SCI ENG ETHICS 8, 429–442 (2002). https://doi.org/10.1007/s11948-002-0065-7
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DOI: https://doi.org/10.1007/s11948-002-0065-7