In May, 2007, the New England Journal of Medicine published an analysis of
dozens of studies on nearly 28,000 people who had taken Avandia. The Journal said that there was a 43% higher risk of
heart attack for those taking Avandia compared with people taking other diabetes drugs or those taking no diabetes medications.
The findings raised
concerns because two-thirds of the people with type 2 diabetes die of heart problems.
On Saturday, February 20, 2010, after a two year
study, Senator Max Baucus (D-Montana) and Senator Charles E. Grassley (R) released a report saying that drugmaker GlaxoSmithKline
knew of possible heart attack risks tied to their diabetes drug Avandia years before they made such information public.
They asked the FDA why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007. Based on its knowledge of the heart attack risks, GlaxoSmithKline "had a duty to sufficiently
warn patients and the FDA of its concerns in a timely manner," the report said. Instead, the company tried to downplay
findings that the drug would increase cardiovascular risks.
