Washington, DCGovernment reports allege GlaxoSmithKline knew about the cardiac risks associated with Avandia but waited years before alerting the public. The confidential reports, made public in The New York Times (02/19/10) recommend that Avandia be removed from the market.
According to the reports, as cited in The New York Times, if every diabetic person were given Actos instead of Avandia, approximately 500 heart attacks would be prevented every month. Avandia is used to treat Type 2 diabetes. It was reportedly linked to 304 deaths during the third quarter of 2009.
GlaxoSmithKline has defended its drug by saying that it has studied Avandia extensively and there is no scientific evidence to show that the drug causes an increase in the risk of heart attacks. The company also says it disagrees with the Senate investigation's conclusions.
Another FDA advisory committee is expected to meet this summer to determine whether or not Avandia should stay on the market.
Rather than warning patients about the risks of Avandia, the government report notes, "G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk."
A trial was ordered to determine the risk of heart attacks, strokes and heart-related deaths among patients taking Avandia, Actos or a placebo. However, officials working in the FDA say the study is "unethical and exploitative" because the patients given Avandia have a much higher risk of adverse events with no additional benefit.
The Senate investigation also reportedly found that GSK—and the FDA—waited too long before warning the public about the risk of heart problems.