This story reports on a investigational drug, flibanserin, that is being developed to treat what is a controversial diagnosis called "hypoactive sexual desire" in women. The popular press has dubbed this drug "Female Viagra" despite that fact that it has few similarities to drugs that treat erectile dysfunction. Preliminary research examining the drug’s efficacy in treating sexual distress and/or low sexual desire were presented at the May 2010 annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG). To place the story in context, previous reports from the manufacturer claimed that flibanserin resulted in "clinically significant" improvement in the number of sexually satisfying events reported by women taking the drug vs. those taking placebo, an absolute difference of 0.7 events per month. The story was detailed and did a good job of presenting information in absolute terms so that the reader could clearly see that reported benefits were small and of unknown clinical significance.
Good reminders that this is a controversial diagnosis and that "some experts see it as the medicalization of what is for many women a relationship issue."
Cost data for flibanserin is not provided. Some projection of cost should be available for any drug this far along in Phase III trials – and for which the company has already begun marketing campaigns. If not from the company, then from stock analysts.
The story properly quantifies the reported benefits in absolute terms which allows the reader to see that they are small. (Results are described in Quality of Evidence comments.) In an interview a study researcher conceded that the absolute number of women reporting benefit was not large.
The story provided statistics on common side effects including daytime sleepiness, dizziness, fatigue, anxiety, dry mouth, nausea and insomnia. These side effects resulted in 15% of those taking flibanserin vs 7% taking placebo withdrawing from the study.
The story does a good job of presenting and evaluating the available evidence. Results are presented in absolute terms, for example that just under one third of women taking flibanserin reported improvement in sexual distress/desire compared to approximately one fifth of women taking placebo. In contrast, these results were presented in relative terms by the manufacturer.
Except for the headline, " ‘Female Viagra’ May Treat Low Sexual Desire", this story avoids disease mongering and notes that "hypoactive sexual desire disorder" in women is a controversial diagnosis. The text clarifies that while the popular press is dubbing flibanserin as the "female Viagra", it is not similar to Viagra or other drugs to treat erectile dysfunction.
Conflicts of interest are disclosed. The story noted that the study researcher interviewed is a paid consultant for the drug manufacturer. An alternative point of view is provided by two independent experts, a psychologist and a sex-therapist. The independent sources comment on the role that personal relationships play in sexual desire and experience which was not addressed or acknowledged by the researchers.
The story indicates that an alternative drug called the Intrinsa testosterone patch is available in Europe, but not in the U.S. The story also notes a difference between these dugs; Intrinsa is a hormonal treatment compared to flibanserin which is a non-hormonal.
The story indirectly informs that reader that flibanserin is not available by noting that it is in phase III clinical trials and that the manufacturer is seeking FDA approval (despite early direct to consumer marketing campaigns).
The story makes it fairly clear that this is a new treatment – also for a new and controversial diagnosis.
The story was apparently based on research presented in abstract form at the annual clinical meeting of the American College of Gynecologists and Obstetricians, although this information has not been published in independently, peer-referred scientific journals.
There is no direct evidence that it relied largely on a news release. In fact, the use of interviews with independent experts makes it clear that independent reporting took place.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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