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by Robert MacKay, Monday, May 20, 2013 | Categories: Female Sexual Dysfunction

Female sexual dysfunction has always been a controversial topic, with discussions targeting everything from the validity of the concept to the possibility of creating a female “Viagra”. So it came as no surprise to us to see that the marketing of a recently FDA approved drug for dyspareunia (painful sexual intercourse) was met with scepticism from a number of quarters. Given the sharp contrast between the manufacturer’s optimistic prognosis for its applicability and the doomsday reports in some papers, we felt inclined to take a closer look at the issue.

The drug, which goes by the name Osphena, is being marketed following two successful 12-week phase III trials to establish efficacy and a longer trial that examined the safety profile of the active ingredient (ospemifene). The key findings indicated a statistically significant difference between placebo and treatment groups, with the latter having 14% greater alleviation of symptoms. In addition to that, there were reports of more side effects in the treatment groups such as urinary tract infections, increased hot flashes and an increased risk for yeast infection.

One aspect that was criticised was whether the marketing of Opshena misrepresented what dyspareunia is and how many women would benefit from the treatment. Essentially, dyspareunia is painful sexual intercourse that can occur due to a range of medical causes that can be congenital or acquired. These include, but are not restricted to endometriosis, vaginal septa, vulvular vestibules, and vaginismus. Osphena is meant to work by enhancing oestrogen levels that lead to vulvo-vaginal atrophy. However, vulvo-vaginal atrophy is a term used for a process that is not restricted to the genital area but results in the thinning of skin and muscles in general. According to the researchers, Opshena would have the potential to be useful for 64 million women in the US alone. We consider this number to be on the high side by a considerable margin.

Although both sides appear to advocate two extremes, we are glad to see that the findings and marketing of this treatment are not going unnoticed. It is important to understand the rigorous methods required for a treatment to pass a phase III trial. Therefore, even smaller effects may be important and sufficient for a treatment to be taken seriously by the research community. Naturally, no pharmaceutical company would wish to harm an individual in order to increase their profits and we are a bit tired of this dated argument being regurgitated in the media.

What we found interesting was the way dyspareunia was explained. Clearly it is a condition that confuses individuals, and we agree that the manufacturers have inflated the number of women that can be helped. Yet we cannot help to wonder whether the marketing really is a case of misrepresentation. From our experience, we know that many women seek to get an informed opinion from clinicians rather than relying on marketing material. Accordingly, clinicians strive to explain treatments, conditions and risks in enough detail for a patient to feel like they are making an informed decision. This is why we feel that some of the commentary on the marketing of Osphena, needlessly underestimates the intelligence of adult women and ethics of clinicians.





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