July 10, 2010 - FDA Advisory Panel To Debate Safety Of Avandia.

USA Today (7/10, Rubin) reported, "A large clinical trial of Avandia, sponsored by its maker, 'was inadequately designed and conducted to provide any reassurance' that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday." The memo, written by Thomas Marciniak is part of a 765-page briefing document prepared by the FDA for the upcoming advisory committee meeting to review Avandia [rosiglitazone]. The New York Times (7/10, A1, Harris) reported on the front page that Dr. Marciniak "found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study's tally of adverse events. Such repeated mistakes 'should not be found even as single occurrences' and 'suggest serious flaws with trial conduct,' Dr. Marciniak wrote." The Washington Post (7/10, Stein) reported that “agency experts remained split over the drug." The Wall Street Journal (7/10, Dooren), HealthDay (7/9, Gardner), MedPage Today (7/9, Phend), and MedPage Today (7/9, Walker) also covered the story.