GSK to face FDA meeting over Avandia safety record
Wednesday 24 February 2010
The Food and Drug Administration (FDA) will hold a public meeting on the possible heart risks of GlaxoSmith-Kline's (GSK) diabetes treatment Avandia in July, the US regulator said yesterday, but it urged doctors to continue prescribing the drug until any new advice was issued.
The move came after Rosa DeLauro, a Democratic Representative in Congress, posted a notice on her website on Saturday saying the FDA should "remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the safety and effectiveness of the drug".
Ms DeLauro, the chairman of the agriculture subcommittee of the Committee on Appropriations, which funds the FDA, was reacting to the release of documents in Congress, including a memo from two FDA safety officials who recommended Avandia should be withdrawn from the US. They said the drug posed a greater risk of heart attacks than alternative treatments.
GSK said the FDA had conducted seven trials into the cardiovascular safety of Avandia since 2007, when concerns were first raised. "None of these randomised clinical trials, which remain the gold standard for evaluating scientific and medical questions, shows a statistically significant association between Avandia and heart attack or other ischemic cardiovascular events."
Avandia sales were worth $3bn (£1.9bn) in 2006, before an article written by the Cleveland cardiologist Steven Nissen in the respected New England Journal of Medicine cast doubts over Avandia's safety. In 2009, GSK made $1.2bn (£780m) from Avandia sales.
Dr Nissen recorded a meeting he held with GSK executives days before his research was published. He told The New York Times that he feared he would come under pressure to change his work. The Congressional report issued on Saturday said that scientists critical of Avandia's safety had been threatened by the company.
GSK rejected the report, saying it "cherry-picks information from documents, which mischaracterizes [sic] GlaxoSmithKline's comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients".
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