A report has claimed that the risk of heart attacks carried by diabetes medication Avandia was known of by its manufacturer years before the evidence concerned was made public.
The report by the US Senate Finance Committee also said the drug maker GlaxoSmithKline had a duty to warn patients and the US Food and Drug Administration of its concerns “in a timely manner”, but instead tried to downplay the findings. The committee is asking the FDA why it allowed a clinical trial to continue after the drug was estimated to have caused 83,000 heart attacks between 1999 and 2007.
Committee members said to FDA Commissioner Margaret Hamburg that their investigators interviewed GlaxoSmithKline and agency employees and whistleblowers. They told her in a letter that the report was based on researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents.
Senator Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee’s ranking Republican, released the report after a two-year inquiry. The drug firm also tried to downplay findings that a rival medication might reduce such risks, it said.
GlaxoSmithKline said in a statement the drug is safe. It said the committee report took data out of context from analyses of Avandia.
Copyright Press Association 2010
Medicines and pharmacy