Healthy Skepticism Library item: 11049

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Publication type: news

U.S. Senators: FDA Pulled Reviewer off Glaxo Drug
Reuters 2007 Jul 25
http://www.medscape.com/viewarticle/560402?src=mp

Full text:

A senior Food and Drug Administration scientist has told congressional investigators that the FDA removed him or her from work on GlaxoSmithKline Plc’s drug Avandia after voicing concerns about the safety of the diabetes pill, two senators said on Tuesday.

The unnamed FDA medical officer at one time was the primary reviewer for Avandia, according to a letter sent to the FDA by Senate Finance Committee Chairman Max Baucus, a Democrat, and Sen. Charles Grassley, the panel’s top Republican.

The scientist has believed since 2005 that there was enough evidence for a strong “black box” warning on Avandia about a risk of congestive heart failure, the senators said.

In a statement titled “Senators reveal effort by the FDA to suppress scientific dissent and downplay safety concerns” released with their letter, they said the reviewer was “sidelined after voicing safety concerns” about Avandia.

The FDA reviewer “was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia,” the senators’ letter said.

The senators said the scientist was interviewed by committee investigators.

“This new allegation is especially significant and raises our level of concern about FDA interference in safety decisions regarding Avandia,” the letter said.

FDA spokeswoman Julie Zawisza said the FDA had received the senators’ letter and would respond.

In June, the FDA said it had asked for a black box warning about heart-failure risk on Avandia and competing diabetes pill Actos, a competitor made by Takeda Pharmaceutical Co Ltd..

Concerns about Avandia’s heart risks arose in May when a study published in the New England Journal of Medicine linked Avandia to a 43 percent higher chance of having a heart attack.

The FDA has said other evidence conflicts with that finding. The agency is holding a meeting of an outside advisory panel on Monday to discuss the potential heart risks of Avandia, known generically as rosiglitazone.

Millions of patients take Avandia, and sales topped $3 billion last year. Glaxo says the drug is as safe as other diabetes medicines.