Posted: 09-13-10 Categories:
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Avandia Recall

Drug safety expert at FDA: Avandia panel had anti-recall bias

FDA drug safety experts Dr. David Graham and Dr. Kate Galperin sharply criticized the agency for including consultants who were biased against an Avandia recall on a 2010 FDA drug advisory panel. This most recent criticism of FDA Avandia review was published in the British Medical Journal (BMJ) on September 7, 2010.

The 2010 joint committee voted 20 to 12 against recommending an Avandia recall to the FDA. Avandia panelists included members of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. In addition, members of a 2007 FDA advisory committee that voted 20-3 against an Avandia recall also were included on the panel, “even though they were no longer active members of either committee.”

Of the 32 panelists who voted at the 2010 meeting, 16 also had voted at the 2007 meeting. All but one of the 16 panelists who attended both meetings voted against an Avandia recall in 2010. Dr. Graham and Dr. Gaperin write:

“The addition of these former members substantially biased the results of the vote on whether rosiglitazone should be withdrawn from the market. Members voting for the first time were 4.4-times (95% confidence interval 1.1 to 17.0; P=0.01) more likely to vote that rosiglitazone be withdrawn from the market than were members who had voted previously to keep it on the market.”

“By inviting these former members to participate in the 2010 meeting, CDER biased the outcome of the vote in favour of rosiglitazone remaining on the market. Had these former members not been included, the vote would have been 10 out of 17 (59%) in favour of rosiglitazone withdrawal, with an additional three in favour of severely restricted distribution.”

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