To the Editor In a meta-analysis of data on flibanserin in a recent issue of JAMA Internal Medicine, Jaspers et al1 concluded that the drug had minimal efficacy and significant risk. The related editorial by Woloshin and Schwartz2 characterized flibanserin as a “marginally effective drug [with] substantial…uncertainty about its dangers.” While we welcome such analyses on novel therapies, we believe that the interpretation of the data and regulatory history struck a heavy-handed tone with a disproportionate emphasis on the risks. As sexual medicine clinicians with decades of experience, we believe that both the meta-analysis and editorial lacked proper understanding of the condition of hypoactive sexual desire disorder (HSDD) and did little to clarify the efficacy of flibanserin. While sexually satisfying events were a coprimary end point in all of the pivotal trials due to regulatory carryover from trials assessing erectile dysfunction treatments in men, it must be emphasized that sexual activity is entirely unrelated to the diagnosis and treatment of HSDD, a condition characterized by decreased or absent sexual desire and increased distress. Thus, the focus on sexually satisfying events as a measure of either HSDD severity or treatment efficacy is misplaced. In an analysis by the US Food and Drug Administration (FDA),3 54% to 58% of premenopausal women treated with flibanserin had clinically meaningful benefit ranging from minimal to very much improved with placebo response rates (40%-48%) that were typical of psychoactive medication trials. The FDA concluded that flibanserin was both safe and effective.
Irwin Goldstein, James A. Simon, Sharon J. Parish. Appropriate Perspective and Context for Newly Approved Medications, Including Flibanserin. JAMA Intern Med. 2016;176(9):1403–1404. doi:10.1001/jamainternmed.2016.3883