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Posts with tag primary reviewer of Avandia removed from review after voicing co

FDA interfered with Avandia safety decisions?

I don't think the Food and Drug Administration (FDA) liked opening this envelope. Yesterday, Senate Finance Committee Chairman Max Baucus, a Democrat, and Senator Charles Grassley, a Republican, sent a letter to the FDA with a serious allegation -- a former FDA primary reviewer for Avandia was removed from her/his work on the drug after voicing safety concerns. This senior FDA scientist was interviewed by committee investigators.

The unnamed scientist believed the evidence for risk of congestive heart failure was strong enough for a "black box" warning on Avandia. With the Senators' letter was a statement titled, "Senators reveal effort by the FDA to suppress scientific dissent and downplay safety concerns." They said the reviewer was literally "sidelined" after speaking up. He was told to stop participating in the review of Avandia's possible cardiovascular safety problems.

The Senators said, "This new allegation is especially significant and raises our level of concern about FDA interference in safety decisions regarding Avandia."

Suppression, interference, sidelining a dissenting scientist -- a FDA conspiracy? This should play nicely with the FDA's upcoming July 30 meeting of an outside advisory panel to discuss Avandia's potential heart risks. Read Allie's earlier post about a doctor claiming Avandia-maker GlaxoSmithKline tried to silence him.

The FDA has stated they received the letter and will respond. Lots of closed door meetings today over at the FDA. Read more in Reuters.

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