Senate report: Drugmaker knew of risks tied to Avandia

Drugmaker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before evidence became public, according to a Senate report.

Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee, and Sen. Chuck Grassley (R-Iowa), the committee's ranking Republican, released the report yesterday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated the drug caused 83,000 heart attacks between 1999 and 2007.

In a letter to FDA Commissioner Margaret Hamburg, also released yesterday, the senators said the committee report was based on researchers' studies of Avandia, internal GlaxoSmithKline documents and FDA documents. They said committee investigators had interviewed GlaxoSmithKline and agency employees as well as what it called anonymous whistle-blowers.

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 could increase cardiovascular risks while also working to downplay findings that a rival medication might reduce such risks, it said.

GlaxoSmithKline said in a statement the drug is safe. It said the committee report took data out of context from analyses of Avandia.

"Contrary to the assertions in the report, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events," GlaxoSmithKline said.

FDA spokesman George Strait said the FDA is reviewing new data and will present those findings to an advisory committee this summer. - AP