Is a Lower Number Worth a Higher Risk?
Taken from the March/April 2015 issue of the Women's Health Activist Newsletter.
Quick-fix weight loss remedies have always been popular, but they have gained even more momentum in recent years due to increased attention to the rising rates of obesity. In 2012, 69 percent of U.S. adults over age 20 were overweight, and 35 percent were obese.1 Internationally, in 2008, 35 percent of people over 20 were overweight and 11 percent were obese; obesity affects almost 1.5 billion adults worldwide, making prevention and treatment efforts a global public health concern.2
Anti-obesity drugs are often touted as “miracle products” that yield results with minimal effort. Misleading ads for these products appear everywhere from magazines to public buses to interstate billboards, and promote the idea that being thin is more important than being at a healthy weight. They portray heavily airbrushed and largely unattainable body parts like six-pack abs and long, lean legs. The ads are not only deceptive, but also encourage weight loss for the sole purpose to improve sex appeal rather than short- and long-term health.
Now there’s another drug on the market. Last September, the Food & Drug Administration (FDA) approved a controversial anti-obesity drug (after previously rejecting it), even though, during clinical trials, it was only minimally effective compared to placebo when combined with diet and exercise. The drug, Contrave, is a reformulation of an anti-depressant (bupropion) and a substance abuse treatment drug (naltrexone). People who took it lost a meager 4.1 percent more weight than those in the placebo group.
The FDA’s current efficacy standard requires weight management products to meet one of two criteria that focus solely on weight loss as an endpoint without regard to drug-specific health benefits. So, we know nothing about whether Contrave’s modest-at-best weight loss results are indicative of long-term health promotion.
Alarmingly, in addition to demonstrating only modest effectiveness, Contrave also proved to be unsafe during its clinical trials. People who took it reported having increased heart and blood pressure rates, and were more likely to experience seizures, compared to those taking the placebo. Serious psychiatric events were also more common in the treatment group — including depression, anxiety, sleep disorders, and psychosis. In fact, people taking Contrave were twice as likely to withdraw from the trial due to adverse events, compared to the placebo group.
Contrave and other minimally effective and unsafe anti-obesity drugs not only don't work that well, but also may actually worsen health issues faced by overweight and obese individuals. Reducing an arbitrary number on a scale while simultaneously increasing blood pressure and risk of serious neuropsychiatric events, does not improve anyone’s health or well-being.
Another concerning aspect of the FDA’s approval of Contrave’s was the brevity of the clinical trials, which only lasted a year. This means we lack information about the complications that may arise from its long-term use. The National Women’s Health Network (NWHN) is adamant about the need for adequate pre- and post-market surveillance of all new drugs and medical devices. That’s why we asked the FDA to insist on three year-long trials before approving any new weight loss drugs. This would provide regulators and consumers with more information on the risks and benefits of long-term use of these obesity drugs. Consumers may be willing to risk rebound weight gain after using a safe weight-loss product, but obesity drugs like Contrave must deliver on their promise of safety first and foremost.
Contrave, like many of the obesity drugs on the market, lacks sufficient data to assess its long-term safety with any confidence. The National Women’s Health Network has long advocated that clinical trials include diverse groups of populations (including women, the elderly, and people of color) and last long enough to identify any long-term complications. When a clinical trial lasts only a matter of months — like Contrave’s did — consumers are forced to rely on adverse event reports after the drugs are on the market (this is called “post-market surveillance”) in order to identify possible side effects. This process allows pharmaceutical companies to maximize their profits and places the burden of risk on consumers.
Women may be interested in losing weight, but at what cost to their health? A “miracle drug” like Contrave, which claims to help people achieve a slim physique, jeopardizes their health to do so, is far more of a curse than a blessing.
1. Centers for Disease Control and Prevention (CDC), FastStats: Obesity and Overweight, website updated January 14, 2015. Available on-line at: http://www.cdc.gov/nchs/fastats/obesity-overweight.htm
2. World Health Organization (WHO), Fact Sheet: Obesity and Overweight, Geneva: WHO, January 2015. Available on-line at: http://www.who.int/mediacentre/factsheets/fs311/en
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