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Conflicts of Interest and the FDA
| November 17, 2011
Thomas Sullivan at Policy and Medicine reports that 'patient groups encourage Congress to remove burdensome FDA rules' which require that each panel meet a quota of members without conflicts of interest. Thomas writes, 'Two years ago, 218 positions of the 600-plus on FDA's 49 advisory committees had yet to be filled, in part because the FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist's view.' This kind of absence rate is extremely disturbing for patients who are waiting for new treatments and products to be approved.'' The disclosures mandated under the Affordable Care Act are meant to facilitate and speed up the process of ensuring that panelists are conflict-free, but are there enough conflict-free panelists to be found?
Merrill Goozner of GoozNews certainly thinks so.' After a recent New York Times article highlighted the conflicts of interest of members on three NIH expert panels convened to issue new guidelines on hypertension, cholesterol and obesity, Merrill took issue.' In his post, Conflict-Free Panels Are Possible & Necessary, he writes, 'When the Food and Drug Administration commissioned a study to see if it couldn't make up its advisory panels with conflict-free experts, the outside consulting firm discovered that it would take about one week to find unconflicted physicians with the skills required to analyze clinical trial and other data needed to serve.'
One week?' The authors of a 2007 study, Measuring Conflict of Interest and Expertise on FDA Advisory Committees (PDF), set out to find experts to replace 17 members of three different committees who had conflicts of interest. ' After a week-long search process, the authors identified approximately 70 experts who didn't have "evident" conflicts of interest. ' However, in the end, the search methods they used, already fairly labor-intensive, weren't comprehensive enough. A few of those 17 members they sought to replace weren't eliminated in their new, supposedly more rigorous, search.' '
Tanya Albert Henry reports for American Medical News that part of the problem is that currently there are no 'clear, specific requirements for what needs to be disclosed when physicians have relationships with medical device and pharmaceutical manufacturers.' ' For example, she notes, a recent study of a Department of Justice Settlement revealed 'complex payment patterns' from joint implant manufacturers to orthopedic surgeons.' Without clear guidelines for disclosure, it can be difficult to determine who has a conflict of interest and how significant it really is.
What constitutes fair compensation for an expert's work?' How much money'what level of relationship'does it take to bias an expert unfairly?' And how can the FDA navigate these issues to work in patients' best interests?' These questions have yet to be answered.
- Patient Advocates: Flies In The Ointment Of Evidence-Based Care ' Jessie Gruman
- NIH to Drop Requirement for Websites Disclosing Researchers' Ties to Industry ' Elaine Schattner
- Niseritide, the 'Lost Decade' and the Pinto ' Patricia Salber
- Laurel & Hardy and Prostate Cancer Chemoprevention ' Gary Schwitzer
- Sunshine Isn't So Bright After All ' Sarah Jorgenson
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