Unpublished FDA study says diabetes drug Avandia should be withdrawn

An unpublished study by a Food and Drug Administration researcher and colleagues at Medicare indicates that as many as 48,000 heart attacks, strokes and other cardiovascular problems in the elderly between 1999 and 2009 could have been averted if the patients had taken other medications instead of the controversial diabetes drug Avandia, the Wall Street Journal reported Friday.

The paper by Avandia critic Dr. David Graham has been submitted to the Journal of the American Medical Assn., but the journal has not acknowledged whether it is considering publication.

The Graham study, which reviewed Medicare records, was reported by the respected pharmaceutical industry blog Pharmalot, which also published an e-mail from Graham to his superiors arguing that senior FDA officials were trying to suppress the work.

The FDA is scheduled to conduct a review of Avandia’s safety next month.

Previous criticisms of the drug can be found here and here. The group Public Citizen has argued that ongoing clinical trials of Avandia should be halted immediately because of the risks of the drug, as has biomedical ethicist Ruth Macklin.

Stay tuned. The argument is sure to get hotter next month.

—Thomas H. Maugh II