Just when I think the Food and Drug Administration can’t do anything else that will surprise me, they manage to pull another rabbit out of the hat.
In this case, five rabbits – Belviq, Qsymia, Contrave, Saxenda, and Vivanse. In January Vyvanse was approved for a condition known as binge-eating disorder. The other four drugs were approved for weight loss. Belviq, Qysmia and Contrave had previously been rejected by the agency. But after 13 years of rejecting any new diet drugs, the FDA has allowed all of these potentially harmful products on the market.
The drugs were approved despite the potential for serious side effects, including suicidal thinking, increased heart rate and cancer risk. There is also no proof the drugs improve the main health concern posed by obesity: heart attacks and other cardiovascular problems. I can almost hear the echoes of the Phen-Phen and Meridia disasters already.
What has changed that allowed the FDA to do an about-face and approve these new diet drugs? Intense pressure has come from the pharmaceutical companies who manufacture these diet drugs, and also from the U.S. Senate, which in 2011 called on the agency to approve new obesity treatments.
What facilitated that pressure? According to an investigation by the Milwaukee Journal Sentinel/MedPage Today, since 2010 pharmaceutical companies spent $51 million lobbying Congress and the FDA on a variety of issues, including obesity.
As long as there have been pharmaceutical companies there has been a quest to reduce waistlines and improve health, but the history of diet drugs is abysmal. Some of the main health concerns posed by obesity are heart attacks and no diet or weight-loss drug has ever been proven to reduce heart attacks, strokes or cardiovascular deaths. This has led some users of these dangerous drugs exposed to injury and even death. Most of the earlier diet drugs (see; Phen-Phen and Meridia) were eventually forced off the market.
I am worried that when it comes to these new drugs history will repeat itself and patients will again be harmed. The FDA appears to have ignored the lessons of history, and all it took to get them to forget was $51 million.
