A Food and Drug Administration advisory panel last week voted not to ban sales of painkillers Celebrex, Bextra and Vioxx, despite the risk of heart problems associated with the drugs. Today, the New York Times reports that 10 of the 32 government panel members who recommended continued use of the drugs had previously served as paid consultants for the drugs’ makers:
If the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx’s return.
The votes of the 10 did not substantially influence the committee’s decision on Celebrex because only one committee member voted that Celebrex should be withdrawn.
The debate over whether experts with drug industry ties should sit on FDA advisory panels has long been a contentious one. “The agency has said it tries to balance expertise — often found among those who have conducted clinical trials of the drugs in question or otherwise studied them — with potential conflicts of interest,” write reporters Gardiner Harris and Alex Berenson.
The Vioxx vote is the latest in a series of news accounts examining scientific and financial conflicts of those who advise the government on critical health issues. Los Angeles Times reporter David Willman has written extensively about the ties of researchers at the National Institutes of Health, which this week announced new ethics rules.
The New York Times reporters drew on a database maintained by the Center for Science in the Public Interest, an advocacy group that tracks scientists’ industry connections based on disclosures in medical journals and other public documents.
Debate is likely to continue over the presence of experts on advisory panels who might have a financial stake in the outcome of a public-health decision. Those opposed include Christopher A. Seeger, a lawyer in New York representing a number of clients suing over Vioxx, who told the Times that advisory panel members are afraid to say “no” out of fear they’ll lose access to lucrative clinical trial research. Those who see a benefit include Dr. John Farrar, a neurologist at the University of Pennsylvania who has received research support from Pfizer (maker of Celebrex and Bextra) and is a panel member. His argument: “I think FDA would have a hard time finding people who are good at what they do who never spoke to a pharmaceutical company.”
Fair enough, but when it comes to crucial public health decisions, the potential conflicts must be clearly spelled out. That’s the role of journalists like Willman, Harris, Berenson and others covering this underreported story.
Dr. Alastair Wood, an associate dean at Vanderbilt University, who chaired the painkiller panel, told the Times he was disappointed that FDA had not done a better job in spelling out the financial ties of committee members.
“I’m a great believer in letting it all hang out,” he said.
So are we.
–Susan Q. Stranahan
Susan Q. Stranahan wrote for CJR.