Studies within the Food and Drug Administration reveal that Avandia, the diabetes medication, should be pulled from the market because of the link to heart attacks. The drug is made by GlaxoSmithKline (GSK) and the confidential studies were released as part of a report by the staff of the Senate Finance Committee.
The studies, released as part of a report on Avandia by staff of Senate Finance Committee members Chuck Grassley (R- Iowa) and Max Baucus (D- Mont.) said that GSK was aware as far back as 2007, that Avandia had a 43% higher risk of cardiovascular events, when Dr. Steve Nissen of the Cleveland Clinic published a study. The Senators also believe that a clinical trial that compares Avandia and rival, Actos, made by Takeda Pharmaceuticals, would be “unethical and exploitative.”
Avandia’s generic name is rosiglitazone, or rosiglitazone maleate. A black box warning was added to the drug, but the Senate committee concludes that GSK intimidated doctors who raised concerns, among them the FDA’s David Graham and Kate Gelperin. They concluded Avandia should come off the market because of the heart attack risk. An FDA panel voted in 2007 to leave the drug on the market.
Doctors believe if Actos was substituted for the blockbuster drug, Avandia, there would be 500 fewer heart attacks and 300 fewer cases of heart failure every month.
