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The New Health Dialogue

A Blog from New America's Health Policy Program

FDA: "Intellectual" conflict of interest more serious than actual conflict

Published:  January 13, 2012
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Conflict of interest is back in the news this week, with a new story in the Washington Monthly by medical journalist Jeanne Lenzer and Keith Epstein. The story, also reported on by the Wall Street Journal and co-published with BMJ, reports that three decisive votes on a recent FDA safety evaluation panel had financial relationships with Bayer--maker of the drugs in question.

Yaz, Yasmin, Beyaz, and Safyral are Bayer's birth control drugs that contain the hormone drospirenone. Such drugs have come under heavy fire in recent years for being unsafe. Consumers and researchers have argued that the drugs increase the likelihood of fatal blood clots, deep vein thrombosis, and other serious adverse events.

In light of those allegations, the FDA convened a panel to assess the evidence. Five or six members of that panel had financial relationships with Bayer; in what appears to be a violation or misapplication of the FDA's conflict of interest rules, they were still allowed to vote. That undermines the intent of conflict of interest rules, which should aim to protect public confidence in the FDA and avoid even the appearance of impropriety. In the end, all conflicted panelists voted that the drug was safe enough to stay on the market; if the their votes had switched, it would have reversed the 15-11 vote.

The truly absurd part of this story is the member the FDA chose to exclude from voting: consumer advocare Sidney Wolfe.  Wolfe had previously made statements critical of the drugs, and so the FDA deemed that he had an "intellectual conflict of interest." Such a charge is inane; if he was conflicted, surely any clinician who had ever prescribed (or declined to prescribe) one of the drugs would be similarly unable to vote! FDA panelists are responsible for doing exactly what Wolfe does: evaluating the evidence and coming to a conclusion. Making familiarity with the evidence a disqualifying factor is patently ridiculous and contrary to the purpose of the board.

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