Detailed disclosures would clarify financial links between doctors and industry

Clear, specific requirements for what needs to be disclosed when physicians have relationships with medical device and pharmaceutical manufactures will be essential to evaluating conflicts of interest inherent to such relationships, a study concludes.

Researchers examined data from a Dept. of Justice settlement with the five largest joint implant manufacturers and found complex payment patterns to orthopedic surgeons. The settlement required the companies to release details on the number of orthopedic surgeons receiving payments, the size of the payments, the aggregate dollar amount and the proportion going to academically affiliated orthopedic surgeons in 2007 and 2008.

Study authors said the number of orthopedic surgeons receiving payments declined substantially after disclosure was required under the settlement in 2007: 526 received payments in 2008, down from 939 in 2007. For three firms that continued to report in 2009 and 2010, the numbers began to rise again, but not to where they were in 2007, said the study in the Oct. 24 Archives of Internal Medicine (link).

Companies paid $198 million in 2007 and $228 million in 2008. However, study authors said the 2008 total included $109 million in one-time royalty buyouts from one company.

The data showed a "modest increase" in the proportion of academically-affiliated surgeons who received money: 44.9% in 2008, up from 39.4% in 2007. These surgeons influence the practice patterns of the next generation of physicians, the study said.

However, the study noted "substantial variation across the firms in the details provided in the disclosed data." This led study authors to conclude that "universal and detailed disclosure with standardized reporting formats and data elements would make these data more useful to patients, providers and policymakers."

"Having more information in the public space is better," said Jason M. Hockenberry, PhD. He was at the University of Iowa and Iowa City Veterans Affairs Medical System at the time of the study and now is an assistant professor at Rollins School of Public Health at Emory University in Atlanta.

Changes in reporting requirements are coming next year under the Patient Protection and Affordable Care Act, which mandates that firms disclose payments to physicians. The act requires companies to report 2012 data to the federal government by March 2013. The Dept. of Health and Human Services must post the information on a publicly available online database in September 2013.

Hockenberry said it is crucial that standardized information is reported under the act and that financial disclosures are linked to clinical practices to help determine whether payments are influencing physicians.

"The reality is we don't know if this is influencing physicians," Hockenberry said. "This is a complex issue and needs to be thought out."

He said it is not wrong for physicians to be compensated and that it wouldn't be good if physicians were concerned that they were being judged for receiving small amounts of money.

"I someday will probably need a hip replacement ... and I want an orthopedic surgeon in on the design of the device," Hockenberry said. "At the same time, disclosure is in order."