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Can Americans trust that the medicines we take are both safe and effective?

That’s the basic question underlying the this week’s FDA advisory committee meeting. The panel of experts from outside the FDA will consider whether GlaxoSmithKline’s diabetes drug Avandia should be banned for safety reasons.

It’s Avandia that’s on trial.  But subject to debate is  GSK’s handling of crucial safety information in Avandia trials. What’s really at stake here is the FDA’s ability to demand and to oversee clinical trials to demonstrate a drug’s safety and efficacy.

The case against Avandia is strong. Observational studies, including a recent analysis of Medicare data by FDA safety expert David Graham, MD, MPH, and colleagues, suggest that Avandia is significantly riskier than Actos, the other FDA approved blood-sugar-lowering drug in the same class.

GSK, on the other hand, points to the results of its own trial of Avandia heart safety, RECORD, as proof the drug is safe.

Critics have lambasted the RECORD study. Now a new FDA briefing, previewed in slides posted on the FDA web site ahead of the advisory panel meeting, casts more doubts on the conduct of the RECORD trial. The briefing, the Thomas A. Marciniak, MD, of the FDA’s division of cardiovascular and renal products, includes a slide titled “Why Should You Believe My Numbers Instead of GSK’s?”

Another FDA briefing, by Susan Leibenhaut, MD, in the FDA’s division of scientific investigations, finds that while some of the discrepancies in the RECORD database were resolved, important questions remain.

GSK has it’s own team of prestigious researchers ready to defend Avandia. Steven Nissen, MD, head of cardiology at Cleveland Clinic and a prominent Avandia critic, will also be on hand and will be delivering a hard-hitting argument for the prosecution.

Stay tuned for a blow by blow report from WebMD.

– Daniel J. DeNoon, senior medical writer, WebMD.