July 13th, 2010
Avandia, Day 1
Larry Husten, PHD
A few hours before the start of the FDA’s advisory panel meeting on Avandia, the New York Times published a story by Gardiner Harris that said GlaxoSmithKline (GSK) began a study comparing the safety of rosiglitazone (Avandia) to pioglitazone (Actos) back in 1999 and spent the next 11 years keeping the study a secret.
The Senate Finance Committee then released a letter sent to FDA leaders and accompanying documents detailing internal GSK discussions about the trial. GSK then issued its response to the Senate letter and documents.
You can read detailed coverage of the FDA advisory panel by Matt Herper at Forbes.com and by myself (Larry Husten) at CardioBrief.org.