“Avandia can cause or worsen heart failure.” That’s what the drug’s black box warning states. But in a lawsuit against the Food and Drug Administration, PCRM is asking the agency to require wording on the label that also alerts patients to safe dietary alternatives to Avandia and other diabetes drugs that may increase the risk of stroke, heart failure, and death.
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. In July, other researchers unveiled 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.
“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 lawsuit points out, “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.”
This month, PCRM also educates health care professionals about the benefits of a plant-based approach to treating diabetes at the American Association of Diabetes Educators annual meeting. Dr. Barnard’s research on how a vegan diet can prevent and reverse diabetes will be presented in a session titled “Insulin Resistance and Diet: Effective Nutrition as First-Line Treatment.”
Diabetes educators will also learn how to help their patients safely and effectively treat diabetes with a vegan diet. PCRM director of diabetes education and care Caroline Trapp, M.S.N., A.P.R.N., B.C.-A.D.M., C.D.E., will present “Acceptability and Effectiveness of a Worksite Program Using a Plant-Based Diet,” and Brenda Davis, R.D., author of Becoming Vegan and Defeating Diabetes, will present “Overcoming the Diabetes Epidemic: A Story of Hope from the Marshall Islands.”
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