FDA and Lifestyle Drugs — The Next Chapter in the Story
For those who may have missed the news from last week, Vivus Pharmaceuticals missed big time with Qnexa. Their FDA Endocrinologic and Metabolic Drugs advisory committee voted against recommending the anti-obesity drug for approval, basing their decision primarily on the absence of long-term safety data. The committee vote was 10 to 6 against approval. A comment made by Dr. Lamont G. Weide, MD, PhD, of the University of Missouri, Kansas City is a telling marker of how attitude is changing in the assessment of drugs seen as lifestyle treatments. Weide said that he was tired of having to take drugs off the market after they have been in use for a few years because of failing to identify problems. “That really is some of what has given the FDA a bad reputation outside in the public. We have a responsibility to protect the public at large.”
The drug development graveyard is filling up with much ballyhooed prescription weight loss drugs.
Technical Communication Myths
My colleague Jessica Mahajan came across this post on the blog TechCommDood talking about common technical communication myths. Myths that apply to medical writing as well.
FDA and Lifestyle Drugs….Drawing a Line?
The winds at FDA appear to be shifting direction when it comes to “lifestyle” drugs. The mood surrounding lifestyle drugs in FDA Advisory Committees suggests the approval bar may have been moved somewhere closer to the neighborhood of infinity.
Now I want to be clear that the precise definition of lifestyle drugs is a subject of debate that I suspect will carry on for some time. I am using the term here as routinely applied in the popular press.
So when we talk about lifestyle drugs, consider that an FDA advisory panel almost unanimously voted on both safety and efficacy grounds against Boehringer Ingelheim’s flibanserin, even though the drug (a re-purposed antidepressant for female libido) did not display side effects of notable concern.
Now the first of three new diet drugs — Vivus Pharmaceuticals qnexa– is up in front of an FDA advisory committee tomorrow (July 15). The two waiting in the wings are Arena Pharmaceutcial’s lorcaserin and Orexigen’s product contrave. There is considerable churn in the pharma press on the Vivus drug as pundits read tea leaves on the future of qnexa.
Perhaps FDA and other health professionals are reconsidering where to draw the line between the social and the medical dimensions of health and treating problems that are often construed as caused by lifestyle choices (like obesity). Some clinical professionals feel that, when drug therapy is available, physicians are less willing to consider non-drug treatments, even when there is no evidence that pharmacotherapy is superior (for example see this paper by Everitt DE, Avorn J, and Baker MW). It is interesting to me to consider the arguments (pro and con) for the use of pharmacological interventions to mitigate the impact of human habit and lifestyle choices.