FDA Memo Blasts Diabetes Medicine Avandia

As the mainstream media have gradually exposed the scandal of unpublished drug-risk studies (for example, the Celebrex/Vioxx affair), the concept of risk-to-benefit analysis has entered public consciousness. While consumers are aware that all prescription drugs come with risks, few know how to weigh these risks vs. the benefits. But we are less likely to take chances with our health when we are educated about the potential dangers of using prescription drugs.
Avandia, a widely prescribed diabetes medication, was scrutinized by two FDA drug-safety reviewers, Dr. David Graham and Dr. Kate Gelperin, who wrote an October 2008 memo (yes, over a year ago!) in which they concluded that Avandia posed serious risks. Graham and Gelperin’s memo stated there was “strong evidence that (Avandia) confers an increased risk of “heart attack and heart failure when compared with Actos.” The researchers estimated that Avandia caused 500 more heart attacks and 300 more cases of heart failure per month than did Actos. In 2007 Dr. Graham had urged an FDA panel to pull Avandia from the market, but the panel voted 22-1 to advise the FDA to allow continued sales of the drug.
Sens. Grassley and Baucus, who serve on the Senate Finance Committee, released the Graham/Gelperin memo as part of a report showing that Glaxo “knew for several years prior to this study that there were possible cardiac risks associated with Avandia.” The FDA appears to serve the interests of corporations whose fees fund the agency’s activities and who employ many former FDA staff members. The Grassley/Baucus report should galvanize every American into action. As we have often written here, the FDA cannot be fixed; it must be fundamentally reformed from the ground floor up.