FDA Petition Calls for Changes in Diabetes Drug Labeling

On December 18, a petition was filed with the FDA by the Physicians Committee for Responsible Medicine. It asks the FDA to require that diabetic medications in the thiazolidinedione class of drugs like Avandia include labeling that states a low-fat vegan diet has been shown to be as effective or more effective than medications taken orally to lower blood sugar in those with diabetes.


The Physicians’ Committee for Responsible Medicine conducted an NIH-funded study which tested the effects of a low-fat vegan diet in patients with type 2 diabetes. It confirmed previous studies which demonstrated the effectiveness of a plant-based diet as a treatment for heart disease and type 2 diabetes. The labeling would also explain that a vegan diet can lower blood pressure and high cholesterol, accelerate weight loss, and prevent and reverse heart disease. A vegan diet is not indicated for everyone; it has some specific risks of its own. But it is much safer than many drugs.
The FDA recently called for a new black box warning on Avandia, alerting patients to an increased risk of heart attacks. The drug already included warnings of heart failure. Researchers estimate that Avandia (rosiglitazone) has caused more than 13,000 heart attacks and heart failure events.
The information that diet can effectively prevent and treat chronic diseases is not new. The famed Portfolio diet from the University of Toronto—so called because it puts a lot of cholesterol-lowering foods together in one meal plan (like stocks in a portfolio)—has been shown to lower blood cholesterol. In a statement issued by Andrew Shao, PhD, vice president for scientific and regulatory affairs at the Council for Responsible Nutrition, “The best advice for consumers is to engage in a lifetime of healthy habits—like not smoking, maintaining a healthy weight, eating a well-balanced diet, and appropriately supplementing with vitamins, regular exercise, and regular visits to a physician. These appear to be best practices. Vitamins play a vital role in promoting overall general health and filling specific nutrition gaps [and] may play a role in helping to lower the risk of chronic diseases. However, vitamin supplements are just one piece of the puzzle, which may be why we didn’t see the results we anticipated from the recent clinical trials. Perhaps we need to revise our expectations that one single healthy habit will serve as a ‘magic bullet’ and allow us to live disease-free after all, one piece does not complete the whole puzzle, but we certainly don’t discard the piece just because it doesn’t fit in a particular spot.” It is worth noting as well that most recent articles critical of vitamins have been interpretive studies rather than trials and have used seriously flawed methodologies.

It is critical that healthcare reform focus on lifestyle to address the growing epidemic of chronic diseases that face the American population. A deeply ingrained bias within government agencies has created a need to address scientific free speech. There will be more information in the weeks ahead about an effort to protect free speech about science. Stay tuned at www.anh-usa.org.