The Food and Drug Administration said Monday that for now, patients should not stop taking the diabetes drug Avandia, subject of a two-year Senate Finance Committee investigation whose findings were revealed Saturday.
A May 2007 study in The New England Journal of Medicine raised concerns that Avandia increased users' heart attack risk. In July 2007, an outside panel of experts convened by the FDA voted 20-3 that Avandia did raise heart attack risk. But the panel voted 22-1 to recommend keeping the drug on the market.
The Finance Committee report concluded that maker GlaxoSmithKline, or GSK, knew of possible Avandia heart risks for several years before the study.
"It can be argued that GSK had a duty to warn patients and the FDA of the Company's concerns," the finance committee report said. "Instead, GSK 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."
In a news release, GSK said the report's conclusions were based on "analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug."
The FDA plans another advisory panel meeting on Avandia in July. In a "drug safety communication" posted Monday, the agency said it was reviewing data received in August from RECORD -- a large, long-term, company-funded study designed to assess Avandia's cardiovascular risks in patients with type 2 diabetes.
"We feel that it is time for a thorough evaluation of all the cardiovascular risks with that drug," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said Monday in a teleconference with diabetes doctors.
Last June in The Lancet, RECORD scientists confirmed that Avandia increases heart failure risk, as noted in a "black box" warning added to its label in August 2007. But, they said, Avandia didn't increase cardiovascular risk compared with standard diabetes drugs.
"We are neither accepting nor rejecting that conclusion," Woodcock said. "We have to go over that study with a fine-toothed comb."
Endocrine Society president Robert Vigersky, a diabetes specialist at Walter Reed Army Medical Center in Washington, D.C., told Woodcock that "everybody's best interest would be served" if the FDA could hold the Avandia meeting earlier. In an interview, he said that "I have to take them at their word" that more time is needed to review data.
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