FDA pulled reviewer off Glaxo’s Avandia drug
A senior Food and Drug Administration scientist has told congressional investigators that the FDA removed them from their work on GlaxoSmithKline Plc's drug Avandia after voicing concerns about the safety of the diabetes pill. The unnamed FDA medical officer was the primary reviewer for Avandia. 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 FDA reviewer was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia. The scientist was interviewed by senate committee investigators. 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 allegation is significant and raises the level of concern about FDA interference in safety decisions.
