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Female Sexual Dysunction is a Medical Issue…Period!

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The debate over female sexual response has been raging since Masters and Johnson in the 1960's and shows no sign of abating anytime soon. This was made clear during the FDA-approval process of Addyi, a pill for the treatment of Hypoactive Sexual Desire Disorder (HSDD), in 2015. The debate that raged in the media at the time, which included input from political pundits, women's health experts, and HSDD sufferers, both fascinated and infuriated me. For what seemed to be a lifetime, they went back and forth on whether HSDD was a disorder developed by pharmaceutical companies to sell a drug and, even if there was a biological origin, whether it warranted medical therapy. One side of the argument believed that HSDD should only be addressed with cognitive and behavioral therapies rather than drug therapy. The opposing side felt that, due to the multifactorial nature of HSDD, this type of approach wasn't always sufficient and that drug therapy should be one of the tools in a clinician's HSDD treatment arsenal. Unfortunately, the debate in the media took away from the important messages that came out of Addyi's approval - that there was finally an FDA-approved therapy for the most common form of female sexual dysfunction (FSD) and that the FDA pledged to support the development of other safe and effective therapies for FSD.

To answer the question about HSDD's biological origins, in 2009 I was part of a team at Stanford that set out to identify the region of the brain in women with HSDD that reacted differently to sexual stimuli (aka, erotic films) compared to women without HSDD.[1] We found that these 2 groups were neurobiologically different when it came to sexual arousal. It turned out that the women with HSDD did not have the same type of activity in the entorhinal cortex, an area of the brain associated with processing emotional memories, as the women without HSDD. Therefore, it stood to reason that this region of the brain, as well as others in the limbic system, could be targets for HSDD drug therapy. Like any medical disorder, several drug companies embarked on development programs to create treatments for HSDD. This pathway was no different than the development programs created by pharmaceutical companies for the treatment of erectile dysfunction (ED) - and there certainly are a lot of those therapies on the market. These companies identified a biological problem (for ED, that's diminished blood flow to the penis) and created the treatment around it. The big difference was that the approval process of Viagra and its counterparts did not become the political juggernaut that Addyi did. To add another layer of complexity to the approval process, a REMS (Risk Evaluation and Mitigation Strategy) program was put in place, which meant that clinicians and pharmacists who prescribed and dispensed Addyi had to undergo an online training and certification program. With so much controversy and hoops to jump through, some clinicians felt that it was easier not to bring up FSD or it's treatment, at all. With 44% of women in this country experiencing a sexual concern, this does not equate to "good doctoring".

Addyi was a coup in that it was the first-in-class drug for the treatment of HSDD, the most common form on FSD. The downside of the Addyi debate in the media was the loss of attention on the most important issue: the women suffering with this problem. There is no question - HSDD is a scientifically proven disorder that deserves evidence-based solutions, both cognitive and pharmacotherapeutic.

Several drug companies have HSDD drugs in the development pipeline that will eventually go up for FDA-approval. Clinicians who address women's sexual function concerns need treatment options to offer their patients, but the controversy only detracts from the countless individuals struggling with FSD, a condition that negatively impacts multiple aspects of a woman's life. Just like male sexual health, women's sexual health is a medical issue, not a political one...period!

[1] Arnow B, et al. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Neuroscience 2009;158(2):484-502

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Topics: Sex Talk health sexual function sexual dysfunction sexual heatlh

Written by Leah Millheiser, MD

Dr. Leah Millheiser is the Chief Scientific Officer of Aytu Women's Health, LLC. At Stanford University Medical Center, Dr. Millheiser is a Clinical Assistant Professor in the Department of Obstetrics and Gynecology and Director of the Female Sexual Medicine Program. In addition, she is a Fellow in the American College of Obstetricians and Gynecologists and the International Society for the Study of Women’s Sexual Health. As a sexual medicine expert, Leah devotes her career to treating all aspects of female sexual health. She has a particular interest in the sexual wellness of cancer survivors. In her gynecology practice, she takes care of women across the lifespan, from adolescence to menopause and beyond.

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