Later today, a committee of advisors to the Food and Drug Administration will vote on whether or not the agency should approve flibanserin - the much-hyped yet controversial "female Viagra." However, the drug has already been rejected twice previously by the organization, who cite safety concerns. In the wake of those decisions, battle lines have
been drawn between those who feel the agency is discriminating against the sexual health of women and those who feel the language of sexual equality has been hijacked in an attempt to force an ineffective and unsafe drug on the market. We take a look at both sides of this dramatic debate.
In the 1990s, Pfizer began development on a drug called UK-92480, intended as a treatment for angina and high blood pressure. The drug worked by inhibiting an enzyme that causes the inside of blood vessels to contract. The theory was, if this process was disrupted, then the cells would relax, improving blood flow and relieving blood pressure.
However, UK-92480 did not work quite as intended. Trials found that the drug amplified the effect of nitrates - the standard treatment for angina - causing blood pressure to fall too low. Side effects of UK-92480 included muscle aches and - amongst male volunteers - increased erections for several days following the initial dose.
Faced with the reality that UK-92480 was not a viable angina treatment, Pfizer took an interest instead in its unintended effects. As a treatment for erectile dysfunction, UK-92480 was much more effective than a placebo. In 1998, the drug was approved for this use by the Food and Drug Administration (FDA), and it was rechristened Viagra.
In the 17 years since, drugs acting as variations on Viagra's mechanism have also made it to market as erectile dysfunction treatments. What has been conspicuous in its absence, however, has been "a Viagra for women."
Following the FDA's second decision not to approve flibanserin, in fall 2014, two well-funded media campaigns - Even The Score and Women Deserve - set about engaging women's groups, starting up petitions and lobbying policymakers on the issue. A mantra of these campaigns is the figure "26-0."
What 26-0 relates to is a claim made by Cindy Whitehead, the CEO of Sprout Pharmaceuticals (who now own flibanserin) - and reportedly the creative mind behind Even The Score and Women Deserve - that 26 drugs have been FDA-approved for male sexual dysfunction and none for women."Women have waited long enough," write Even The Score, of their pro-flibanserin petition, which is reported to have attracted more than 40,000 signatures. "In 2015, gender equality should be the standard when it comes to access to treatments for sexual dysfunction."
Accusations of data manipulation
However, critics have claimed that Even The Score's campaign is built on misinformation. The 26 products for male sexual dysfunction are actually different regional brands of the four main erectile dysfunction treatments, which themselves adhere to a similar mechanism.
Another statistic wielded by the campaigns - the claim that 43% of American women have a sexual dysfunction - has also come under fire. The figure is drawn from a contentious 1994 survey that gave its female respondents the option of answering yes or no to whether they had any sort of sexual problem, but the survey did not collect any data on what the nature of the problem was - even the senior author of that study has reportedly claimed the statistic is misused.
That "a biological lack of desire to have sex negatively impacts 1 in 10 American women" was questioned in a high-profile LA Timespiece by Kinsey Institute research fellow and sexologist Prof. Ellen Laan, and Leonore Tiefer, professor of psychiatry at NYU School of Medicine and founder of the New View Campaign.
"No diagnostic test has identified any biological cause - brain, hormone, genital blood flow - for most women's sexual problems," the pair wrote. Rather, they claim that low sexual desire in women more likely reflects a difference in desire between the two partners.
"It is unethical and unscientific to attribute a couple's discrepancy in desire to the woman's biological deficit," they continue, pointing out that studies have shown women's response to both test medications and placebo drugs is high. "These repeated findings do not support the 'unmet medical need' theory."
What Laan and Tiefer's article and the New View Campaign emphasize is that Viagra and flibanserin are false equivalents. Viagra treats erectile dysfunction, while Sprout claim that flibanserin is an antidote for low sexual desire in women. Viagra does not increase male libido; rather it acts on the mechanism that allows an erection to happen.
What flibanserin is concerned with - boosting sexual desire - is more amorphous and complex. New View even argue that male and female sexual dysfunctions are also not equivalents, so a female Viagra would therefore not be appropriate for women.
'Hypoactive sexual desire disorder' and the DSM
The New View Campaign take issue with the current sexual dysfunction classification implemented by the American Psychiatric Association (APA) in its 1980 edition of the Diagnostic and Statistical Manual of Disorders (DSM), which envisions male and sexual "dysfunction" as equivalents across four categories: sexual desire disorders, sexual arousal disorders, orgasmic disorders and sexual pain disorders.
They consider that this has led to a reductive, mechanistic perception of how female sexuality works in relation to male sexuality. They argue that women's sexual problems are less physiological and genital-focused than men's, that "women generally do not separate 'desire' from 'arousal,' women care less about physical than subjective arousal, and women's sexual complaints frequently focus on 'difficulties' that are absent from the DSM."
"The DSM takes an exclusively individual approach to sex, and assumes that if the sexual parts work, there is no problem; and if the parts don't work, there is a problem," summarize the campaigners.
Instead, the campaigners say, it has fostered a commercial drive to produce "a female Viagra" - a pharma sensation that will repeat the massive success of that drug for a new audience, regardless of whether pharmacology is the correct intervention, or to what extent there is a problem that requires treatment.
In fact, the specific illness that Sprout argue flibanserin treats - hypoactive sexual desire disorder (HSDD) - was removed from the DSM in 2013.
Medical News Today spoke to Thea Cacchioni, an assistant professor of women's studies at the University of Victoria in British Columbia, who testified against flibanserin the first time it was unsuccessfully submitted for FDA approval in 2010. She asserted bluntly of flibanserin's position in the modern pharmaceutical landscape: "there is no recognized illness it treats."
"There are many problems with the HSDD disorder, as I mentioned in the hearing," Cacchioni told us, "how could we ever come up with a baseline level of normal desire? Norms of desire vary from era to era and culture to culture. Also, research shows that most desire problems are caused by external factors - interpersonal, relationship issues, social judgements and pressures related to especially women's sexuality, feelings of inadequacy, work stress, etc."
As fascinating as the cases for and against the idea of a pharmaceutical intervention for female sexual dysfunction are, the issues that Cacchioni and others expressed the greatest concern about when testifying in 2010 were much less philosophical and more to do with hard data.