Endocrine Insider
July 16, 2010

(See full issue)

On Wednesday, July 14, Endocrine Society Past-President Robert Vigersky, MD, testified before advisory committees of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), stating that concrete evidence is lacking to make a final determination on the safety of Avandia (rosiglitazone).  The Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee were tasked with considering whether the data show that the risk of keeping the drug on the market outweighs the benefit of the drug to the care of patients with type 2 diabetes.

Dr. Vigersky’s comments focused on factors that the FDA must consider regarding the safety of rosiglitazone, highlighting four points for the advisory committees’ consideration.

1. The FDA decision on rosiglitazone will have broad implications on the entire process of drug development.
2. In its deliberations, the FDA must consider how this drug is being used in the real world by clinicians and patients and therefore only focus on Active Comparator studies rather than those with placebo control.
3. The FDA should give greatest weight to prospective, randomized-controlled trials of adequate power having pre-specified and adjudicated endpoints.
4. Real and significant discrepancies exist among studies on the safety of rosiglitazone in several areas, including patient population, study design, data interpretation and analysis, and the conclusions drawn.  As a result, the Society does not feel that a clear-cut evidence-based recommendation can be made either for or against the retention of rosiglitazone on the market and/or the continuation of the TIDE trial.

The full testimony can be viewed on the Society’s website.

The FDA advisory committees were specifically asked to address a series of questions on the safety of rosiglitazone.  The committee members found that there is sufficient evidence to be concerned that rosiglitazone increases the risk of heart attacks and strokes compared with other medications used to treat type 2 diabetes.  However, they found that the evidence is insufficient to show that the drug increases the risk of death.  As a result, 20 committee members voted that rosiglitazone should remain on the market with varying forms of restrictions while 12 voted that the drug should be removed from the market.  A final decision will be made by the FDA in the near future. 

The Society worked with the American Association of Clinical Endocrinologists and the American Diabetes Association to issue two joint statements to providers—one on Monday, June 12 in advance of the FDA hearing and another on June 15 in response to the FDA advisory committees’ decision.  Both statements can be viewed on the Society’s website.