The altered classification of sexual dysfunction of women in the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the approval by the FDA of the first drug to treat low sexual desire in females have led to a debate among researchers and clinicians.

How was female sexual dysfunction originally classified?

Psychosexual dysfunction was first mentioned in the DSM published in 1980. Previous versions did not cover sexual disorders. One of the included psychosexual dysfunctions was inhibited sexual desire, which was based on the Human Sexual Response Cycle (HSRC): “disturbances in sexual desire and in the physiological changes that characterize the sexual response cycle”. In the following edition published in 1994, the word inhibited was no longer used. A feature of the HSRC model is the universal range of phases of sexual response that are basically the same in men and women (excitement, arousal, orgasm, resolution). The criterion for Hypoactive Sexual Desire Disorder was also similar for both sexes.

The DSM classification and the HSRC both received a lot of criticism in the last decades. One complaint concerns the absence of defined duration and severity criteria. According to the criteria, nearly half of the American females have a sexual dysfunction. More defined severity criteria resulted in a much lower rate.

The classification of sexual disorders was heavily altered in the DSM edition published in 2013, especially regarding female sexual disorders. Defined severity and duration criteria to all sexual dysfunctions were presented, the requirement that the symptoms cause “clinically significant distress” was added and the HSRC phases were dropped. Disorders regarding arousal and desire (FSAD and HSDD) were deleted an a new disorder was introduced: Female Sexual Interest/Arousal Disorder (FSIAD). The criteria for low sexual arousal/desire included behavioral, physical and subjective aspects. Females need to meet three of six criteria (polythetic approach), as not all women experience the same arousal/interest problems and express them in various ways. 

What pharmaceutical treatments are available for low sexual desire in women?

A lot of criticism is also targeted at the increased medicalization of sexuality. The pharmaceutical industry tried to create a female version of Viagra. The creation of a pharmaceutical market for women included the promotion of the notion that Female Sexual Dysfunction is a urgent public health concern that requires treatment.

In 2004, trials of Viagra for females with arousal disorders were stopped due to men’s and women’s  fundamentally distinct relationship between desire and arousal. The focus was then redirected to treating low sexual desire, but the FDA disapproved a testosterone patch and gel. Other drugs are still in the developmental phase.

Flibanserin is the first drug for treating HSDD in premenopausal women that received approval by the FDA in 2015, albeit it with a serious safety alert and after several applications. It has effect on dopaminergic and serotonergic transmitter systems. Research on the impact of the drug in women with HSDD indicate marginal benefits, especially given the significant incidence of adverse events.

A difference from the previous (unsuccessful) applications was the advocacy campaign ‘Even the Score’ in 2014, which included health professionals, women’s health organizations and patients. They wanted to raise more awareness for HSDD and address gender inequality regarding sexual dysfunction treatments. They (falsely) claimed that 26 drugs for the male problem were approved and none for women. Even The Score gathered many signatures and their campaign was backed by women’s organizations and congresswomen.

What narratives did the patients mention?

FSD-patients attended and testified at the FDA Patient-Focused Drug Development Public Meeting in 2014. 5 out of 8 panel members and 7 out of 12 non-panel members who testified received payments for their travel from a pharmaceutical company and Even The Score. With the exception of one, all women had sought treatment and some were still taking drugs for FSD.

Two women declared being devastated when the previous Flibanserin trails were discontinued and told about the dramatic consequences for their sexual desire. Others also described how it had affected their relationships, feelings (feeling guilty, wanting to have their ‘old’ sexual desire back, wanting to feel feminine and connected to their partners), friendships, family and work life. They all described the lack of sexual desire in physiological terms. Feminist narratives focus on the right of women to receive medication and having treatment choices, especially as there are so many drugs for men available (which is false).

Trials funded by pharmaceutical companies consider women without sexual desire as having a health problem that requires a pharmaceutical salutation. They do not see sex (and sexual desire) as diverse and varied, and pay no attention to the several possible reasons for the lack of desire (aging, cancer, stress, hysterectomy, fatigue, medication use). Additional problems regard the media: press coverage lacks a critical look at essential terms, conflicts of interest, the efficacy/safety of drugs and issues of trial design.

Research is limited due to the choice of participants. Studies focused on Western, heterosexual, middle aged women in long-term and monogamous relationships. Black, single, lesbian and women younger than 30 were not represented in trials. Drawing conclusions about the sex lives and sexual desires of all women from these limited studies is therefore not appropriate.

What recommendations are proposed?

There is a number of recommendations for clinicians, journalists and researchers. Regarding clinical work and research: better assessments and definitions that acknowledge that desire and sex have several meanings and interpretations. The variability of women’s sexual experiences also needs to be better acknowledged by researchers. Media: more critical and comprehensive coverage (conduct, outcomes and history of trials, including side effects and limitations). Why were earlier trials discontinued or treatments disapproved? Are there conflicts of interest? Lastly, women need to be offered a truly informed choice, by also being told that a reduced sexual desire does not always equal the presence of a dysfunction, and they need to be informed about the numerous non-pharmacological solutions.