A new bombshell fell as a panel of experts met in suburban Washington to weigh the fate of Avandia, a controversial diabetes drug that raises heart risks.
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New allegations about GlaxoSmithKline's handling of safety questions about Avandia have surfaced.
Documents, first reported on by the New York Times, show that more than a decade ago the maker of Avandia studied Actos, a rival diabetes medicine, to learn which was better. Avandia lost.
Strictly speaking, the test didn't compare the medicines head to head. But the company now known as GlaxoSmithKline monitored the effect of Actos on fats in the bloodstream using the same measures and techniques as it had in previous clinical tests of Avandia. That way the researchers could compare data from the different studies to see if a full-fledged, prospective comparison was worth the risk.
It wasn't, they decided.
Avandia looked worse on how it affected bad cholesterol and triglycerides. A company e-mail in 2001 from Dr. Martin Freed, a drug development executive no longer at GSK, said of the test:
This was done for the US business, way under the radar and we lost .... Per Sr Mgmnt request, these data should not see the light of day to anyone outside GSK.
For its part, GSK said in a statement Tuesday that the documents released by Senate Finance Committee were cherry picked from more than 14 million pages and don't give a full, accurate picture of Avandia.
Furthermore, the test, dubbed Study 175, looked only at Actos — not Avandia — and didn't examine heart attacks, the company said. But subsequent studies of Avandia, GSK says, didn't show an increase in hardening of the arteries.
The risk of heart attack and death with Avandia use are the key safety issues being weighed by the committee of experts advising the Food and Drug Administration.
A letter from Sens. Max Baucus (D-MT) and Charles Grassley (R-IA) to FDA Commissioner Margaret Hamburg says the results of that study and others unfavorable to Avandia were either not shared with the agency in a timely way or went unpublished.