Archivos de Ortopedia y Traumatología
Número 45, 14 de Enero de 2010
Noticia adicional
INTERNAL MEDICINE & ETHICAL ISSUE: -Accuracy of conflict-of-interest disclosures reported by physicians
Background
The recent public reporting of payments made to physicians by manufacturers of orthopedic devices provides an opportunity to assess the accuracy of physicians' conflict-of-interest disclosures.
Methods
We analyzed 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.
To ascertain the reasons for nondisclosure, a survey was administered to physicians who had received payments that were not disclosed.
Results The overall rate of disclosure was 71.2% (245 of 344 payments). For payments that were directly related to the topic of the presentation at the meeting, the rate was 79.3% (165 of 208); for payments that were indirectly related, the rate was 50.0% (16 of 32); and for payments that were unrelated, the rate was 49.2% (29 of 59) (P=0.008).
In the multivariate analysis, payments were also more likely to have been disclosed if they exceeded $10,000 (P<0.001), were directed toward an individual physician rather than a company or organization (P=0.04), or included an in-kind component (P=0.002).
Among the 36 physicians who responded to the survey regarding reasons for nondisclosure (response rate, 39.6%), the reasons most commonly given for nondisclosure were that the payment was unrelated to the topic of presentation at the annual meeting (38.9% of respondents) and that the physician had misunderstood the disclosure requirements (13.9%); 11.1% reported that the payment had been disclosed but was mistakenly omitted from the program.
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.
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,1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25 the suppression of negative results,26,27,28,29,30 restrictions on the behavior of the investigators,19 and the use of biased study designs.19
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.31
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
Recently, the five companies that account for nearly 95% of the market for total hip and knee prostheses — Biomet, DePuy, Smith and Nephew, Stryker, and Zimmer — were required, as part of a settlement with the U.S. Department of Justice,33 to make public all payments that were made to physicians during the 2007 calendar year (see the Supplementary Appendix, available with the full text of this article at NEJM.org).
We used these disclosures to collect information on company payments to physicians that were not reported by the physicians.
The purpose of this study was to assess the extent to which conflict-of-interest disclosures made by physicians reflected payments made to these physicians, as reported by for-profit companies.
To this end, we analyzed the payments that were made to physicians in 2007, as reported by five leading manufacturers of orthopedic devices, and compared them with conflict-of-interest disclosures made by physicians who were authors of presentations or served as board members or committee members at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons.
** Our primary outcome measure was the accuracy of conflict-of-interest disclosures as reported by physicians.
** Secondary research questions centered on factors that are potentially associated with conflict-of-interest disclosure.
NEJM.- Volume 361:1466-1474 October 8, 2009 Number 15
Kanu Okike, M.D., M.P.H., Mininder S. Kocher, M.D., M.P.H., Erin X. Wei, B.A., Charles T. Mehlman, D.O., M.P.H., and Mohit Bhandari, M.D
SEE FULLTEXT
http://content.nejm.org/cgi/content/full/361/15/1466
http://www.e-medicum.com/noticiasDelDia/verNoticia.php?noticia=84210
