In his posting, Thomas A. Marciniak, medical team leader of the division of cardiovascular and renal products at the FDA's Center for Drug Control and Evaluation, said that "RECORD was inadequately designed and conducted to provide any reassurance about the [cardiovascular] safety of rosiglitazone" and that "RECORD suggests the (sic) rosiglitazone increases the risk for [heart attacks]."
Last June, Glaxo used the trial results to tout the drug's safety.
"RECORD provides important and reassuring information about Avandia for physicians fighting diabetes," said Dr. Ellen Strahlman, Glaxo's chief medical officer, in a statement released at the time. "We believe that the results showed that Avandia is safe."
On Friday, the company, in a prepared statement, said, "The RECORD study was conducted according to good clinical practices and the data are reliable. . . RECORD demonstrated that Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death compared to metformin and sulfonylureas."
But Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, said Friday, "If the data from RECORD had truly been mishandled in some way, not only is it going to pretty well be the end of Avandia in the clinical world, but it's going to put GlaxoSmithKline under the magnifying glass in an important way for clinicians going forward. They'll lose credibility, and that's tough to get back."
"There is an alternative drug out there," Garratt added. "From the clinical side, it's a fortunate circumstance that we find ourselves in, since we have an alternative product that seems to have [litt
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