FDA Considers Stopping Avandia Study; Ethics Concerns Raised

The U.S. Food and Drug Administration is considering whether to stop a safety study comparing Avandia to another diabetes medication.  If the study is stopped, it is possible that the FDA will remove the drug from the market.  It has been estimated that more than 200,000 people in the U.S. alone suffer serious, sometimes even fatal, side effects caused by prescription drugs.  See information on unsafe drugs and medical devices.

Avandia was linked to an increased risk of heart attack and stroke by a Cleveland Clinic cardiologist in 2007.  Later that year, the FDA undertook a study comparing adverse events from Avandia to Actos, a diabetes drug not linked to similar problems.  But some scientists have protested the study, saying that it is unethical to compare a drug that has known adverse events to an apparently safer alternative.  The FDA has requested the Institute of Medicine to review the ethics of such comparative studies.

For the full story, go to the Wall Street Journal.