It seems old hat--the U.S. Food & Drug Administration's protecting drug companies' interests at public safety's expense. Tomorrow, the House Oversight & Government Reform Committee will hear testimony on the FDA's role in evaluating the diabetes drug Avandia.
People taking Avandia have a 43% higher risk of heart attack than those taking other diabetes drugs or nothing, according to a study in the New England Journal of Medicine. Even studies by Avandia's maker, GlaxoSmithKline, showed a 30% higher risk.
According to the New York Times, an FDA scientist pushed for black-box warnings on Avandia's label; after complaints from FDA officials with ties to Glaxo, the scientist "was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia."
AFter investigating the scientist's claims, Senator Charles Grassley (R-Iowa) sent a letter to the FDA commissioner, saying "'I hope you recognized what is wrong with this picture.... I also sincerely hope that this is not standard practice within the F.D.A.'”
Grassley was being polite. For years, he has spotlighted the FDA's questionable drug-safety policies. Click here for examples (e.g., Vioxx, Viagra and Ketek).
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