Misleading ads for these products — which appear everywhere from magazines to public buses to interstate billboards — promote the idea that being thin at any cost is more important than being at a healthy weight.
The National Women’s Health Network (NWHN) has long urged the Food and Drug Administration (FDA) to enforce more stringent standards for anti-obesity drugs. The current efficacy standard for weight management drugs to meet one of two criteria; both criteria focus solely on weight loss as the endpoint rather than also assessing drug-specific health benefits and harms. The fact is, research shows that drug-assisted weight loss alone does not necessarily improve people’s overall health outcomes.
The NWHN supports women who want to become healthier by losing weight. We firmly believe that all weight-loss products and treatments must be safe for the people who use them. Sadly, this isn’t always the case.
For example, the Lap-Band is a medical device that has been approved for weight loss; it is also promoted as having health benefits beyond weight loss, including improving Type II Diabetes, hypertension, and high cholesterol. Gastric banding (the surgery to put a band around part of the stomach) is touted as “the surgery that could save your life” — a claim that goes significantly beyond weight loss. Yet, data do not back up these claims. The NWHN believes that patients need accurate information about the Lap-Band’s effectiveness compared to the risks of surgery and the (as yet unanswered) questions about the device’s safety.
Contrave is another example. This anti-obesity drug was approved in 2014, but may actually do more harm than good to users. Clinical trials demonstrated that Contrave may increase people’s blood pressure and heart rate, which is dangerous; it may also increase the risk of serious mental health conditions like depression and anxiety. These adverse effects counteract any potential health benefits that might result from weight loss. Worse, we don't even know the drug’s full dangers. Rather than insisting on adequate pre-approval safety tests with specific safety endpoints, the FDA decided to approve Contrave, then rely on post-market studies to identify serious and potentially life-threatening risks. This approach privileges drug companies’ profits over women’s health.
The NWHN has provided testimony to the FDA urging that the agency require drug manufacturers to prove that their products offer drug-specific health benefits for users. It is vitally important that consumers be able to trust the FDA to ensure that the drugs and medical devices it approves are not only safe but also that they have proven health benefits.
The National Women’s Health Network is committed to ensuring that women have access to accurate, balanced health information and services. Stay informed about this issue by signing up for our e-alerts, and by connecting with us on Facebook and Twitter.