PCRM Sues FDA Over Avandia’s Side Effects

PCRM wants diabetes patients to know about dietary alternatives to dangerous oral diabetes drugs. To ensure that doctors and patients get the facts, PCRM filed a suit against the Food and Drug Administration this July.

The lawsuit, filed in the U.S. District Court for the District of Columbia, targets Food and Drug Administration (FDA) commissioner Margaret Hamburg, M.D., for failing to act on a PCRM administrative petition. The petition urges 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.

“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.”

The lawsuit came after researchers released data linking Avandia to life-threatening side effects that might have killed or injured tens of thousands of people. Following these findings, the FDA took expert and public testimony on Avandia at a special joint meeting of two advisory panels.