In two weeks, an FDA advisory panel will meet to discuss the safety of the drug Avandia – a diabetes drug which, according to recent studies, may increase the risk of heart attack by 43%. Amongst the members of the panel will be six doctors who have financial ties to the pharmaceutical industry.
It’s not as if this is a new phenomenon – in fact, just the opposite. A study last year by the Journal of American Medicine revealed
“…the extent to which panel members were receiving support from the very companies whose drugs they were voting on — a clear conflict of interest.
The report found that in meetings held by 16 advisory panels between 2001 and 2004, at least one panel member had a conflict in 73 percent of meetings. And here’s an even more shocking indictment: In 22 percent of the meetings examined in the JAMA study, more than half of the individual panel members at those meetings had a conflict of interest.” Yahoo Health News
The newly-appointed Avandia panel members are merely the latest in a long line of panel members who have had ties to the industry, including those that made decisions about medicated heart stents, Celebrex, Bextra and Vioxx. (A 2005 panel on those three drugs voted to keep them all on the market – even after two of them had been pulled for increased risk of heart problems and strokes.).
When questioned, doctors insist that financial ties to pharmaceutical companies don’t influence their votes, including several who will be sitting on the Avandia panel. However, an analysis of the Celebrex/Bextra/Vioxx panel votes showed just the opposite:
Of the 30 votes cast by the 10 panel members [who had relationships with the drug companies] on whether Celebrex, Bextra and Vioxx should continue to be sold, 28 favored the drugs. Among the 66 votes cast by the remaining 22 members of the panel [without conflicts of interest], just 37 favored the drugs. The members with financial ties to the companies were 10 times more likely to favor the drugs as those without such ties. San Francisco Chronicle
In that case, I agree wholeheartedly with Merrill Goozner:
“They shouldn’t appoint people with conflicts of interest,” said Merrill Goozner, the director of the Integrity in Science project at the Washington-based Center for Science in Public Interest, in an interview. “The public perception of the evenhandedness of the process will be immeasurably enhanced if they appoint only people who do not have conflicts.”
Recent drug safety legislation that passed the House of Representatives addresses the issue by limiting the FDA to grant only one conflict of interest waiver per advisory panel. Experts with conflicts of interest without waivers could present information to the panels, but are not allowed to vote. Let’s hope that the final draft of the bill that goes to President Bush for signing maintains this strong language and starts us on a new path of un-conflicted advice from our country’s medical experts.