A recent opinion piece in the Journal of the American Medical Association faults the federal Food and Drug Administration for not adequately taking gender differences into account for medical device clinical trials.
Authors Sanket S. Dhruva, MD, and Rita F. Redberg, MD, MSc, note early on that women generally have higher bleeding rates and procedural death rates than men, meaning the risk/benefit assessments for implanted medical devices can be different for women.
The FDA is aware of this situation, and has put out guidelines calling for adequate enrollment of women in clinical studies. But the fact that those guidelines are classified as nonbinding recommendations “raises the fundamental question of whether these important guidelines will be followed,” the piece states.
The authors cite several examples of studies where this has been a problem. For example, a left ventricular assist device was approved for patients with advanced heart failure based on data from just 44 women, making up 23 percent of the study participants.
Although women were noted to have a three-fold increase in stroke risk compared with men as well as more bleeding and infection, the device manufacturer specifically markets it to women.
“Such marketing, while perhaps well meaning, is misleading in the absence of sufficient numbers of women to ensure safety and effectiveness,” the piece states.
See the full text here: http://jama.ama-assn.org/content/early/2012/02/24/jama.2012.254.full