Senate Report: Glaxo Knew of Avandia Risks

WASHINGTON (TheStreet) -- A Senate report says that GlaxoSmithKline (GSK) knew about potential cardiac risks from its Avandia diabetes drug long before they were made public.

The report is the result of a two-year inquiry and was released Saturday by Sen. Max Baucus (D., Mont.), who heads the Senate Finance Committee, and Sen. Charles Grassley (R., Iowa).

The senators are also asking the Food and Drug Administration why it allowed a clinical trial of the drug to go forward after the agency had already estimated that the drug caused tens of thousands of heart attacks, the Associated Press reported.

This six-year study, which compares the safety of Avandia to Takeda Pharmaceuticals' Actos diabetes medication, is still enrolling patients, the AP noted. Glaxo agreed to conduct the study in 2007 at the request of the FDA.

But the Senate report quoted FDA researchers as calling the study "unethical and exploitative." This suggests there was disagreement inside the agency over how to deal with Avandia.

The report said that the drug company "had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner."

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But GlaxoSmithKline said Saturday in a statement that scientific evidence fails to establish a link between Avandia and increased risk of heart problems.

The New England Journal of Medicine in 2007 published an analysis of multiple studies on almost 28,000 people who had taken Avandia, and the analysis showed there was a 43% higher risk of heart attack for people taking the drug than for people taking other diabetes medication or no medication at all, the AP noted.

Shares of GlaxoSmithKline closed Friday at $38.26.

-- Written by a member of TheStreet.com staff.

This article was written by a staff member of TheStreet.com.