More than 20 percent of payments made to surgeons by the five leading orthopedic device makers were not disclosed by the docs during presentations of their research, according to a study in the New England Journal of Medicine.
The study examined reports of payments made to physicians by five manufacturers of total hip and knee prostheses in 2007 — DePuy, Smith & Nephew, Zimmer Holdings Inc., Biomet Inc. and Stryker Corp. — and reviewed the disclosure statements for any doctors who gave a presentation or served as a committee member or board member at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons.
The study’s authors then surveyed the physicians who failed to disclose the payments to find out why.
The results showed that the overall rate of disclosure was 71.2 percent; for payments that were directly related to the presentation, the rate was 79.3 percent. Only half of indirectly related and unrelated payments were disclosed.
“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, the suppression of negative results, restrictions on the behavior of the investigators, and the use of biased study designs,” the study’s authors wrote. “The most notable finding of our study, however, was the high rate of nondisclosure. A total of 20.7 percent of directly related payments and 50.0 percent of indirectly related payments received during the 2007 calendar year were not disclosed, despite instructions directing each participant to make a disclosure ‘if he or she has received something of value from a commercial company or institution, which relates directly or indirectly to the subject of their presentation.’ The size of these undisclosed payments was substantial: the 43 directly related payments that were not disclosed totaled $4,320,563, and the 16 indirectly related payments that were not disclosed totaled $7,772,105.”
The five companies reviewed in the study account for nearly 95 percent of the market for total hip and knee prostheses. Leaders of the five firms, which settled kickback charges, earlier this year said their new procedures ensure that their interactions with surgeons are transparent, above-board and, above all, absolutely necessary to the development of new devices and technologies.
According to the study’s survey, the most common reasons for nondisclosure were that the payment was unrelated to the topic of the presentation and that the disclosure requirements were misunderstood. Eleven percent of the respondents said their payments were disclosed, but inaccurately printed in the conference program.
The study could be a boon for advocates of so-called “sunshine laws” akin to the gift bans enacted in Massachusetts and Vermont that mandate disclosure. A similar measure is being considered at the federal level.
“Disclosure is key, but self-disclosure by physicians may not be so accurate,” Mininder Kocher, a Harvard Medical School orthopedic surgeon who participated in the research, told the Wall Street Journal. “We were a little surprised at how high the nondisclosure rate was. Some of that might have been intentional and perhaps people shouldn’t be trusted, but I think the big part is it’s very confusing how self-disclosure happens now in scientific meetings and in journals.”
American Academy of Orthopaedic Surgeons president Joseph Zuckerman told the Journal that the group clamped down its conflict-disclosure policies.
“In 2007 or 2008, it was a different deal than it is now. … We have made conflict of interest front and center,” Zuckerman said, adding that he pulled in about $132,000 last year from Exactech Inc. for a shoulder-replacement system he helped design.
Relationships between doctors and the device industry “have benefited millions of patients,” he told the newspaper.
Some of the study’s authors themselves reported receiving cash from device makers: Kocher disclosed grant support from ConMed Linvatec, a consulting deal with ConMed Linvatec, Covidien, Biomet subsidiary EBI and Smith and Nephew; Charles Mehlman received grant support from Abbott Spine (now part of Zimmer), DePuy Spine, Globus Medical, Medtronic and Synthes; Mohit Bhandari received grant support from DePuy, Smith and Nephew, Stryker, and Zimmer and was a consultant for Amgen, Osteogenix, Pfizer, and Zelos Therapeutics.