Surgeons Fail to Disclose Corporate Payments

Oct. 10, 2009— -- Orthopedic surgeons who received payments from device makers often failed to follow disclosure policies required by their chief professional society, researchers said.

Nearly 30 percent payments to surgeons serving as board and committee members of the American Academy of Orthopedic Surgeons (AAOS), and to presenters at its 2008 annual meeting, went unreported, according to Dr. Kanu Okike, of Harvard University.

The AAOS written policy requires disclosure of all payments -- including non-cash remuneration such as travel, gifts, entertainment, and meals -- from companies selling products related directly or indirectly to presentation topics.

Yet, some 20 percent of payments directly related to presentation topics at the 2008 meeting went undisclosed, as did half of indirectly related and unrelated payments, Okike and colleagues found.

The researchers suggested that, in light of their findings, the current disclosure system based on physician self-reporting may soon be replaced by mandatory reporting by companies making such payments.

"Legislation requiring all drug and device manufacturers to publicly disclose payments to physicians is currently pending in the U.S. Congress and has been met with widespread support," Okike and colleagues wrote.

"On the basis of the results of our study, one might expect the adoption of such policies to allow the identification of conflicts of interest that were previously undisclosed."

Following the Money

The researchers compared disclosure statements printed in the AAOS 2008 meeting program with payment records in 2007 released by five manufacturers of knee and hip prostheses.

The manufacturers -- Biomet, DePuy, Smith and Nephew, Stryker, and Zimmer -- made the payment records public as part of a settlement with the Department of Justice, which was investigating an alleged payola scheme involving financial inducements to surgeons.

Okike and colleagues identified 344 payments in these records that were made to AAOS board or committee members or to researchers presenting at the group's 2008 meeting.

Of these, 245 (71.2 percent) were disclosed in the final meeting program.

The study authors did not say how many AAOS meeting participants received payments, but they did find that 91 failed to report payments.

Okike and colleagues sent them questionnaires about the reasons for the nondisclosure, which were completed by 40 percent.

Just under 40 percent of respondents said the payment was unrelated to their presentation topic. Misunderstanding of the disclosure requirement was cited by 14 percent, and 11 percent said they had reported the payment but it was mistakenly omitted from the meeting program.

Larger payments were more likely to be disclosed by physicians, Okike and colleagues found. About 90 percent of those exceeding $100,000 were disclosed, compared with just 43 percent of payments less than $10,000.

Payments made to individual physicians rather than an organization to which the physician belonged were also more likely to be reported: disclosure rate 78 percent versus 46 percent.

Board and committee members and presenters at symposia or instructional courses were more likely to disclose payments than physicians who did not have such roles.

Payments directly related to the presentation topic, according to criteria adopted by Okike and colleagues, were also more likely to be reported than those indirectly related or unrelated.

The researchers noted that the AAOS policy required disclosure from participants who "received something of value from a commercial company or institution, which relates directly or indirectly to the subject of their presentation."

Payments were considered directly related in the study if the presentation topic focused specifically on knee or hip implants.

Presentations on other aspects of knee or hip arthroplasty, such as antibiotic prophylaxis during such procedures, were deemed indirectly related to payments from the five companies.

Presentation on other topics altogether were classified as unrelated.

Okike and colleagues identified 208 payments as directly related to the presentation topics, of which 165 were disclosed (79 percent).

Fifty-nine payments went to physicians presenting on unrelated topics, of which 29 were disclosed (49 percent). Half of the 32 payments to physicians whose presentations were indirectly related went undisclosed.

Okike and colleagues said the high rate of nondisclosure could have relatively innocent explanations.

Could Non-Disclosure Be a Mistake?

"One possibility is that the physicians in question did not consider the undisclosed payments to have been related to the subject of their presentation," they said, noting that their survey found this to be at common explanation.

The disclosure requirement may also have been confusing, the researchers said. "The policies regarding conflict of interest and its disclosure are constantly in flux, and it is possible that additional education regarding disclosure requirements may be needed."

Okike and colleagues identified several limitations to their study. Their method of determining payment relatedness could have been faulty, and omissions in the printed meeting program may have led the researchers to undercount disclosures submitted by participants, they noted. Their survey also had a low response rate.

In addition, the study focused on disclosures at one meeting of a single specialty society, covering a specific set of payments.

In a prepared statement responding to questions about the study, AAOS President Dr. Joseph D. Zuckerman, said that "Since 2008, we have taken steps to make our process and emphasis on mandatory disclosure more robust."

Zuckerman, head of orthopedic surgery at the NYU Hospital for Joint Diseases in New York City, said those steps included:

Launching an electronic system for reporting disclosures, accessible all year long

Requiring that all payments and relationships be disclosed, whether or not they are related to presentation topics

Increasing education efforts for members on the importance of disclosure

He added that relationships with industry are good for physicians and patient care, as long as they are transparent.