The New England Journal of Medicine recently published a research study on the “Accuracy of Conflict-of-Interest Disclosures Reported by Physicians” reviewing data from five companies that were recently required, as part of a settlement with the U.S. Department of Justice, to make public all payments that were made to physicians during the 2007 calendar year. The companies—Biomet, DePuy, Smith and Nephew, Stryker, and Zimmer—according to the report, account for nearly 95% of the market for total hip and knee prostheses.
The study analyzed 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 of Orthopaedic Surgeons.
Results
The report provided the following findings:
– The overall rate of disclosure was 71.2%
– Disclosure for payments directly related to the topic of the presentation at the meeting was 79.3%
– Disclosure for payments indirectly related was 50.0%
– Disclosure for unrelated payments was 49.2%
The report also found that payments were more likely to be disclosed if:
– They exceeded $10,000
– Were directed toward an individual physician rather than a company or organization
– They included an in-kind component
– They were made to a symposium presenter or instructional-course lecturer at the annual meeting
– They were made to a board or committee member
– They were directly related to the topic of presentation
The range of payments to physicians was as follows:
– 61.9% were monetary and in-kind
– 28.9% were monetary only
– 9.2% were in-kind only
– The median payment was $17,181.00
– The average was $150,758.16
– 18.3% of payments were under $10,000
– 39.2% of payments were between $10,000 and $100,000
– 42.4% of payments were above $100,000
– 47 payments totaled more than $1 million
Approximately 25% of the payments that were made in 2007 were made to physicians who were authors of presentations or who served as committee members or board members at the 2008 annual meeting of the of Orthopaedic Surgeons. Almost 70% of the payments were directly related to the topic of the presentation at the annual meeting. In addition, recipient’s reported disclosure statement included the disclosure of royalties for most of the large payments.
The report then focused on the reasons for nondisclosure by administering a survey to the 91 physicians (which is an extremely low number) who did not disclose payments in the final program of the 2008 annual meeting. The survey was administered by the McMaster University Division of Orthopaedic Surgery. Only 20.7% of directly related payments went undisclosed, while 50% of indirectly related payments were also not disclosed. Among the reasons why physicians did not disclose payments:
– 38.9% said that the payment was unrelated to the topic of the presentation at the annual meeting
– 13.9% misunderstood the disclosure requirements
– 11.1% reported that the payment had been disclosed but was mistakenly omitted from the program.
As a result of these responses, the rate of nondisclosure should not be surprising. There is no intentional failure to disclose payments for almost 70% of nondisclosures, and considering the limitations of this report, it is likely that this rate of nondisclosure is not accurate.
For example, the research underestimated the number of unrelated payments and, consequently, the overall rate of disclosure, because they assessed payment relatedness by comparing the topic of presentation at the annual meeting with the specialty of the companies (total hip and knee replacement.
Additionally, since 11.1% of survey recipients reported disclosing conflicts that were not printed in the program at the annual conference, it is likely that NEJM also underestimated the disclosure rate.
Another possibly for unrepresentative disclosure rates is that none of the physicians surveyed indicated that receipt of payments after the disclosure deadline may have been a factor in nondisclosure of payment.
Conclusions
As NEJM correctly points out, “disclosures have nearly always been reported by physicians.” While until recently, there have been few means of confirmation or verification of such disclosures, this report shows clear evidence that physicians are in fact reporting their payments properly. With almost 80% of physicians disclosing directly related payments, the only way to get 100% is by doing just what NEJM did: create a uniform reporting methodology.
Once this new form is given a year to be adapted and changes are made, physicians will no longer have the confusion of misunderstanding disclosure requirements, and hopefully such studies will publish all disclosure information properly. As a result, the outcome of NEJM’s effort to show such a high rate of participation in disclosing significant educational and research activities gives patients the trust and confidence they need in their doctors.