Senior FDA Scientist Removed -- for Voicing Concerns About Avandia
August 16, 2007
The Food and Drug Administration (FDA) has reportedly removed a senior FDA scientist from work on diabetes drug Avandia because the unnamed scientist voiced concerns about the drug’s safety.
"This new allegation is especially significant and raises our level of concern about FDA interference in safety decisions regarding Avandia," Congressional investigators said in a letter sent to the FDA.
Since 2005, the scientist, a medical officer who was once Avandia’s primary reviewer, believed that Avandia’s risks warranted a strong “black box” warning for its risk of congestive heart failure.
In May 2007, a study in the New England Journal of Medicine found that those taking Avandia had a 43 percent higher chance of having a heart attack.
The scientist was "sidelined after voicing safety concerns," the Congressional letter said, and “was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia.”
The FDA said it did ask for a black box warning for Avandia’s heart risks in June, and an outside advisory panel is meeting to discuss the risks further. The Agency has received the letter, according to FDA spokeswoman Julie Zawisza, and is planning to respond.
Avandia, made by GlaxoSmithKline Plc, brought in more than $3 billion in sales in 2006.
Reuters July 25, 2007