Accuracy of Conflict-of-Interest Disclosures Reported by Physicians

The question of independence of decision making from financial benefits in medicine and other areas of healthcare remains an ongoing problem. It exists, it is being more exposed, it is insidious and it affects important decision making processes. No discipline is free of the pernicious influence of commercial pressure – how this translates into risk Vs benefit is a more complex question.

In a recent study out in the NEJM, the authors analysed the reports of payments made to physicians by five manufacturers of total hip and knee prostheses in 2007. For each payment recipient who was an author of a presentation or served as a committee member or board member at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons, the disclosure statement was reviewed to determine whether the payment had been disclosed.

Conclusions In this study of self-reported conflict-of-interest disclosure by physicians at a large annual meeting, the rate of disclosure was 79.3% for directly related payments and 50.0% for indirectly related payments.

Kanu Okike, Mininder S. Kocher, Erin X. Wei, Charles T. Mehlman, and Mohit Bhandari Accuracy of Conflict-of-Interest Disclosures Reported by Physicians N. Engl. J. Med., Oct 2009; 361: 1466 – 1474 View Full Paper

The first paragraph of the article is presented below.

Financial conflict of interest in biomedical research has been associated with a number of potential pitfalls, including an increased likelihood of positive (pro-industry) conclusions,^[1-25} the suppression of negative results,^[26-30] restrictions on the behavior of the investigators,^[31] and the use of biased study designs.^[32] Although some academic medical centers have sought to manage the financial relationships of their investigators, most interested parties — including the U.S. government, professional organizations, and medical journals — have required only that potential conflicts of interest, including those that were present at the time of publication or presentation of the research, be fully disclosed.^[32] Historically, these disclosures have nearly always been reported by physicians, and there have been no means of confirmation or verification. However, there is reason to believe that this policy may change in the near future, since there is legislation currently pending in the U.S. Congress that would require companies to publicly disclose payments made to physicians.^[32]

1. Okike K, Kocher MS, Mehlman CT, Bhandari M. Conflict of interest in orthopaedic research: an association between findings and funding in scientific presentations. J Bone Joint Surg Am 2007;89:608-613. [Free Full Text]
2. Yaphe J, Edman R, Knishkowy B, Herman J. The association between funding by commercial interests and study outcome in randomized controlled drug trials. Fam Pract 2001;18:565-568. [Free Full Text]
3. Kjaergard LL, Als-Nielsen B. Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ 2002;325:249-249. [Free Full Text]
4. Baker CB, Johnsrud MT, Crismon ML, Rosenheck RA, Woods SW. Quantitative analysis of sponsorship bias in economic studies of antidepressants. Br J Psychiatry 2003;183:498-506. [Free Full Text]
5. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 2003;290:921-928. [Free Full Text]
6. Finucane TE, Boult CE. Association of funding and findings of pharmaceutical research at a meeting of a medical professional society. Am J Med 2004;117:842-845. [CrossRef][Web of Science][Medline]
7. Montgomery JH, Byerly M, Carmody T, et al. An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia. Control Clin Trials 2004;25:598-612. [CrossRef][Web of Science][Medline]
8. Friedman LS, Richter ED. Relationship between conflicts of interest and research results. J Gen Intern Med 2004;19:51-56. [CrossRef][Medline]
9. Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry 2005;162:1957-1960. [Free Full Text]
10. Bell CM, Urbach DR, Ray JG, et al. Bias in published cost effectiveness studies: systematic review. BMJ 2006;332:699-703. [Free Full Text]
11. Jørgensen AW, Hilden J, Gøtzsche PC. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. BMJ 2006;333:782-782. [Free Full Text]
12. Ridker PM, Torres J. Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005. JAMA 2006;295:2270-2274. [Free Full Text]
13. Kelly RE Jr, Cohen LJ, Semple RJ, et al. Relationship between drug company funding and outcomes of clinical psychiatric research. Psychol Med 2006;36:1647-1656. [CrossRef][Web of Science][Medline]
14. Etter JF, Burri M, Stapleton J. The impact of pharmaceutical company funding on results of randomized trials of nicotine replacement therapy for smoking cessation: a meta-analysis. Addiction 2007;102:815-822. [CrossRef][Web of Science][Medline]
15. Tungaraza T, Poole R. Influence of drug company authorship and sponsorship on drug trial outcomes. Br J Psychiatry 2007;191:82-83. [Free Full Text]
16. Peppercorn J, Blood E, Winer E, Partridge A. Association between pharmaceutical involvement and outcomes in breast cancer clinical trials. Cancer 2007;109:1239-1246. [CrossRef][Web of Science][Medline]
17. Bero L, Oostvogel F, Bacchetti P, Lee K. Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others. PLoS Med 2007;4:e184-e184. [CrossRef][Medline]
18. Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS. Relationship between funding source and conclusion among nutrition-related scientific articles. PLoS Med 2007;4:e5-e5. [CrossRef][Medline]
19. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003;289:454-465. [Free Full Text]
20. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167-1170. [Free Full Text]
21. Bhandari M, Busse JW, Jackowski D, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ 2004;170:477-480. [Free Full Text]
22. Cunningham MR, Warme WJ, Schaad DC, Wolf FM, Leopold SS. Industry-funded positive studies not associated with better design or larger size. Clin Orthop Relat Res 2007;457:235-241. [Medline]
23. Leopold SS, Warme WJ, Fritz Braunlich E, Shott S. Association between funding source and study outcome in orthopaedic research. Clin Orthop Relat Res 2003;415:293-301. [CrossRef][Medline]
24. Shah RV, Albert TJ, Bruegel-Sanchez V, Vaccaro AR, Hilibrand AS, Grauer JN. Industry support and correlation to study outcome for papers published in Spine. Spine 2005;30:1099-1104. [CrossRef][Web of Science][Medline]
25. Fenton JJ, Mirza SK, Lahad A, Stern BD, Deyo RA. Variation in reported safety of lumbar interbody fusion: influence of industrial sponsorship and other study characteristics. Spine 2007;32:471-480. [CrossRef][Web of Science][Medline]
26. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine — selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171-1173. [Free Full Text]
27. Rennie D. Thyroid storm. JAMA 1997;277:1238-1243. [Free Full Text]
28. Schafer A. Biomedical conflicts of interest: a defence of the sequestration thesis-learning from the cases of Nancy Olivieri and David Healy. J Med Ethics 2004;30:8-24. [Free Full Text]
29. Berenson A. Evidence in Vioxx suits shows intervention by Merck officials. New York Times. April 24, 2005:A1.
30. Tong EK, England L, Glantz SA. Changing conclusions on secondhand smoke in a sudden infant death syndrome review funded by the tobacco industry. Pediatrics 2005;115:e356-e366. [Free Full Text]
31. Okike K, Kocher MS, Mehlman CT, Bhandari M. Industry-sponsored research. Injury 2008;39:666-680. [CrossRef][Web of Science][Medline]
32. S.301: Physician Payments Sunshine Act of 2009 (GovTrack.us). (Accessed September 11, 2009, at http://www.govtrack.us/congress/bill.xpd?bill=s111-301.)