It is standing room only here at the advisory panel meeting on GlaxoSmithKline's Avandia. I count about 300 people in the main ballroom and about 50 more watching on closed circuit in an overflow breakout room. The place is crawling with PR people, especially from Glaxo which like most drug companies at the center of a storm like this one has set up a war room here.
In my previous blog entryI summed up "Team Glaxo's" presentation. Then it was the FDA's turn.
Several staffers made presentations. But Dr. David Graham, a top FDA drug safety expert who the media labeled a "whistleblower" in the Vioxx saga, summed things up by saying, "Does (Avandia) increase the risk of heart attacks? We believe the answer to that question is 'yes'." He went on to say the FDA found a 20-70% higher risk of heart attacks within six to 12 months of going on Avandia.
One FDA endocrinologist--diabetes specialist--said she reviewed more than 100,000 pages of information about the class of diabetes drugs known as TZDs which Avandia is apart of. The files were so big, she said, IT had to expand her computer's capacity. The FDA and GSK winnowed that down to about 700 pages for the panelists.
Again,Glaxo says the data are inconclusive and inconsistent and that Avandia is no worse than any other diabetes drug when it comes to heart risk.
The panel is expected to vote this afternoon on whether Avandia increases heart attack risk and, if so, if it should be taken off the American market.
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