By now you’ve probably read it: a study published in the New England Journal of Medicine today found that 3 in 10 orthopedic surgeons did not disclose financial arrangements they had with medical device makers – relationships that five device companies were required to disclose in online databases as part of a settlement with the U.S. government over illegal marketing. The authors compared the payments disclosed by the companies in 2007 to the disclosures required of presenters, committee members and board members at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons. The free full text is here.
This is a big deal. And it makes the crosscheck function of the Physician Payments Sunshine Act – which we’ve talked about here and here – seem more necessary than ever. That's because the Sunshine Act would basically set up a bigger version of what the device companies have done, a public online database into which drug and device companies would report annually.
This study suggests voluntary physician reporting is less complete than company reporting, and in the case of the orthopedists meeting, significantly so. The discrepancy represents $4 million in undisclosed payments related to physicians research. That’s a lot from a relatively small sample of the medical device industry (344 total payments), and it suggests there may be a lot more undisclosed payments out there.
"We were a little surprised at how high the nondisclosure rate was," co-author Dr. Mininder Kocher told the Wall Street Journal.
So, how to account for such discrepancy? One common argument made is that disclosure policies and forms differ widely, creating confusion. Fourteen percent of respondents to a follow-up survey the authors gave the non-disclosing physicians said that they misunderstood the requirements.
But another argument we hear a lot when physicians have failed to disclose hundreds of thousands -- sometimes millions – of dollars in company payments, is that it wasn’t relevant to the research at hand, the paper they were presenting, the treatment guidelines they were writing. Merrill Goozner over at Gooznews digs in to this.
Looking at the follow-up study the researchers did, Goozner notes that this relevance argument is the main reason (about 40 percent) respondents gave for non-disclosure: the money that appeared on the devicemakers’ websites wasn’t relevant to their presentation. But the NEJM study shows that one of five payments directly related to a presenter’s research still went undisclosed.
Besides, Goozner asks: “Is ‘relevance’ relevant?” He doesn’t think so. “In my view,” Goozner writes, “it's just a convenient excuse for not baring all and letting the reader/listener/reviewer decide. It's time to get rid of the relevance dodge.
"For those steeped in the arcana of conflict-of-interest disclosure rules, the relevance test is one of the major bones of contention. If you consult for Pfizer, and talk about a drug from AstraZeneca, should you disclose your consulting gig? "Of course" is the easy answer since the companies compete on a wide range of products. But what if your consultancy is on a rare disease in which AstraZeneca has no product or development program?
"Those Talmudic distinctions offer an easy out for physicians on the payroll of drug and device firms, allowing them to hide some of their financial ties from editors at major journals and federal officials screening nominees for advisory committees. Their internal gavel comes down: not relevant, no disclosure required.
"The beauty of the court settlements in the device cases, as well as the Physician Payments Sunshine Act in the health care reform bills, is that they ignore the fine distinctions and opt for universal disclosure. But as this new study points out, even in the wake of having an easily accessible database, physicians will find reasons to avoid making those disclosures in public fora, whether in a printed article or before making a speech to an annual convention.Check out a comparison of the Sunshine provisions in the health reform bills at the Sunshine Act Guide.
--Kate Petersen, PostScript blogger