Credit: Don Buciak
Last week, U.S. Food and Drug Administration Commissioner Margaret Hamburg told the advocacy group Public Citizen that the FDA may loosen conflict-of-interest rules for experts who serve on the agency’s advisory panels. These panels wield considerable power when it comes to FDA decisions about approving drugs and medical devices, and for pulling them off the market when evidence surfaces that they may cause patients harm.
Why loosen the rules? Commissioner Hamburg said the agency is having trouble finding experts to fill its advisory panel slots. In other words, anybody expert enough to be on an FDA panel undoubtedly has a conflict.
Or maybe the FDA just isn’t looking very hard. In 2008, Jeanne Lenzer -- an independent journalist -- and I created a list of more than 100 experts in fields ranging from epidemiology to neurology to emergency medicine, every one of them independent from industry conflicts of interest. We made the list available to our fellow journalists at the website, Healthnewsreview.org, a site that grades health stories. Dozens of journalists from top news outlets, including the New York Times, Bloomberg, and the Wall Street Journal, have requested the list, and used it to find sources for their stories -- or at least we hope they have.
If Lenzer and I can readily find more than 100 industry-independent experts, what’s stopping the FDA? Is there really a problem filling the slots for advisers, or is the agency simply responding to pressure from Congress? According to a story in Bloomberg this week, “Republicans in Congress and manufacturers have criticized the pace of FDA reviews as too slow, blaming unanticipated requests for safety information from FDA staff and advisers.”
Bloomberg quoted Representative Fred Upton of Michigan, the chairman of the Energy and Commerce Committee, as saying FDA’s conflict-of-interest rules are slowing new product approvals. (According to Opensecrets.org, Upton received nearly $300,000 in campaign contributions from the pharmaceutical industry and health professionals during his 2009-2010 re-election campaign).
Where’s his evidence that conflict of interest rules are delaying truly effective drugs from reaching patients? Indeed, where's the evidence that his own conflicts-of-interest are not affecting his position on this issue?
I ask because we already have plenty of instances where FDA advisors with conflicts-of-interest have failed to serve the public interest. To take just one ready example, in 2005 an FDA advisory panel voted to keep painkillers Vioxx, Bextra, and Celebrex on the market, despite mounting evidence that Bextra and Vioxx significantly increased patients’ risk of heart attack, stroke and death. Ten of the 32 members of that panel had financial ties to manufacturers. Out of 30 votes cast by those ten, 28 were in favor of keeping the three drugs on the market.
Loosening conflict-of-interest rules at the FDA seems particularly wrongheaded in the wake of recent scandals involving researchers and physicians whose industry ties appear to have biased their judgment. Last month, three Harvard psychiatrists were sanctioned for violating their university’s conflict-of-interest policies. The most prominent of the trio, Joseph Biederman, is widely credited with promoting the use of powerful drugs known as atypical antipsychotics in children. These drugs have turned out to have devastating side effects for many patients. Biederman earned an estimated $1.6 million in consulting fees from the drugs’ makers between 2000 and 2007, but failed to report the income to Harvard as required.
Jeanne Lenzer and I have sent Commissioner Hamburg our list of industry-independent experts. With a little effort, surely the FDA can find a few more.