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Lessons from the Avandia Controversy

"The time has come to reassess what should be expected of a new drug to treat diabetes," concludes an editorial written by Dr. Robert Misbin, a Medical Officer for the U.S. Food and Drug Administration (FDA).

The editorial suggests that the FDA "reevaluate criteria for approval of drugs to treat type 2 diabetes," in light of the recent controversy surrounding the diabetes drug rosiglitazone (Avandia).

Rosiglitazone, approved by the FDA in 1999, came under fire earlier this year when a meta-analysis in the New England Journal of Medicine reported that it may increase the risk of heart attacks. An FDA advisory committee concluded that the evidence against the drug's safety was insufficient to have it withdrawn from the market. But the episode "undermined the confidence that patients have in the drugs they take and in the physicians who prescribe those drugs," Misbin wrote. "It cast further doubt on FDA's ability to protect patients from harm."

Misbin concluded that it "is no longer enough" to show that a new drug is more effective than placebo in lowering glucose levels. "New drugs should be tested in comparison to other antidiabetic agents that are already in use," he wrote. "A plan should be in place at the time of approval that will determine what benefits and harm can be expected from chronic use."

Diabetes Care, published by the American Diabetes Association, is the leading peer-reviewed journal of clinical research into the nation's fifth leading cause of death by disease. Diabetes also is a leading cause of heart disease and stroke, as well as the leading cause of adult blindness, kidney failure, and non-traumatic amputations. For more information about diabetes, visit the American Diabetes Association Web site http://www.diabetes.org or call 1-800-DIABETES (1-800-342-2383).