WASHINGTON—In a lawsuit filed this month against the Food and Drug Administration, a doctors group seeks to compel the agency to alert patients to safe dietary alternatives to Avandia and other diabetes drugs that may increase the risk of stroke, heart failure, and death. The nonprofit Physicians Committee for Responsible Medicine (PCRM) is filing the suit in the U.S. District Court for the District of Columbia.
The lawsuit targets FDA commissioner Margaret Hamburg, M.D., for failing to act on a PCRM administrative petition urging the FDA to require that diabetes drugs carry warning labels telling patients that low-fat plant-based diets can effectively treat type 2 diabetes without dangerous side effects associated with oral medications.
A 2006 study funded by the National Institutes of Health found that a low-fat plant-based diet was as effective as oral medications at reducing blood glucose and cholesterol in people with diabetes.This month, other researchers unveiled data linking Avandia to life-threatening side effects that may have killed or injured tens of thousands of people. The FDA took expert and public testimony on Avandia at a special joint meeting of two advisory panels on July 13 and 14.
“A plant-based diet is as effective as drugs for lowering blood sugar, and much more effective for trimming body weight,” says PCRM president Neal Barnard, M.D. “Doctors and patients need the facts.”
As the doctors point out in their lawsuit, “PCRM’s petition requested that FDA require a disclosure in the labeling of drugs, such as Avandia, used to manage blood glucose in diabetes treatment. The disclosure would state that a low-fat plant-based diet has an efficacy and safety profile that can be as favorable as, or more favorable than, oral diabetes medications. FDA has failed to provide a substantive response to PCRM’s petition in a reasonable time, in violation of the Administrative Procedure Act.”
Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit health organization that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in research.