Oct. 7 (Bloomberg) -- Doctors failed to disclose almost a third of payments, or at least $12 million, from companies when participating in a 2008 medical meeting, according to a study on physicians’ self-reports of potential conflicts of interest.

Of 344 payments made by five medical-device makers to physicians making presentations at last year’s meeting of the American Academy of Orthopaedic Surgeons, 245, or 71 percent, were disclosed, the report published in the New England Journal of Medicine found. About 29 percent of the compensation wasn’t disclosed. Payments included royalties on products doctors helped develop, fees for consulting services and costs of lodging, meals and transportation, the report said.

Disclosure is essential because such relationships may cause a pro-industry bias, said Mininder Kocher, an associate professor of orthopedic surgery at Harvard Medical School in Boston and a lead author of the study. The research published today showed self-reporting doesn’t necessarily yield complete transparency, he said.

“Some of it is that some of the requirements are confusing and somewhat open to interpretation,” Kocher said in a telephone interview yesterday. “There is some confusion about what types of relationships are supposed to be reported.”

The researchers used data on 2007 payments to physicians from five makers of hip and knee surgical implants -- Biomet Inc., Johnson & Johnson’s Depuy, Smith & Nephew Plc, Stryker Corp. and Zimmer Holdings Inc. -- available on the companies’ Web sites. The firms were required to publicly report all payments to physicians that year as part of a settlement with the U.S. Department of Justice over whether the companies paid physicians to use their devices.

Disclosure Payment Comparison

The researchers compared that data with the disclosures by physicians presenting or serving on boards or committees at the 2008 meeting of the American Academy of Orthopaedic Surgeons. The group told doctors to disclose whether “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 report said.

Twenty-one percent of directly related payments and half of indirectly related payments weren’t disclosed, the study found. The 43 directly related payments not disclosed amounted to $4.3 million, while the 16 indirectly related ones totaled $7.8 million. Individual sums ranged in size from $6 to $7 million, with an average size of $151,000, Kocher said.

The report did not give the total amount for all 99 undisclosed payments as well as all industry payments to doctors at the medical meeting.

Reason for Nondisclosure

The leading reason given for nondisclosure was that the doctor said payment didn’t relate to the presentation topic, the study found by sending a survey to the 91 physicians who didn’t disclose payments in the final program of the meeting. Thirty- six of the 91 physicians responded to the survey.

The American Academy of Orthopaedic Surgeons has changed its disclosure policies since the 2008 meeting, held at the beginning of the year, said the association’s president, Joseph D. Zuckerman. Participants in the meeting must now submit disclosures online, and aren’t allowed to attend without fully completing the document, which asks for more detail than last year’s, he said.

“The changes we made weren’t in response to the study; we made those changes to make things better,” said Zuckerman, who is also a professor and chair of the department of orthopedic surgery at the New York University Hospital for Joint Diseases. “There should be transparency about this.”

Beneficial Relationships

While disclosure is important, relationships between physicians and industry can be beneficial for patients, Kocher said.

“Advances we’ve made in medicine and devices have come from positive relationships between physician innovators and industry,” he said. “Also, at a time when federal funding of medical research is falling, industry funding has been very important.”

The potential that such relationships may skew results to favor companies also exists, which increases the value of disclosure, Kocher said.

“It is essential in the orthopedic industry that companies engage with surgeons who can help them evaluate products, educate their peers in the safe and effective use of these products and populate clinical studies,” said Bill Kolter, corporate vice president of public affairs at Warsaw, Indiana- based Biomet. “Just because surgeons are being funded to do work by industry does not mean that they are necessarily creating conflicted data.”

Sunshine Act

Legislation requiring companies to disclose payments to physicians was proposed in the U.S. Senate in January, called the Physician Payments Sunshine Act of 2009. Introduced by Senator Chuck Grassley, an Iowa Republican, and Senator Herb Kohl, a Wisconsin Democrat, the bill aims to provide transparency in the relationship between physicians and medical manufacturers.

“There’s a large movement for more disclosure, more sunshine, more getting all of those payments out in the open, which we certainly support,” said Andrew Van Haute, associate general counsel for the Advanced Medical Technology Association, or AdvaMed, a Washington trade group. “Those payments are by and large fair-market value payments for services that are the lifeblood of a lot of these device companies,” such as consulting, product development and training other physicians on how to use the products, he said.

The American Academy of Orthopaedic Surgeons supports the Sunshine Act, Zuckerman said.

“Not only is it making it more transparent but it adds some consistency across the board,” he said.

“The main thrust of disclosure has been self-disclosure from physicians, and that may not be so accurate,” Kocher said. “Perhaps simplifying disclosure rules or having mandatory disclosure from the companies might be a better way forward.”

To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net.

Last Updated: October 7, 2009 17:00 EDT