Even the Score, a women’s health initiative committed to pushing for drugs to treat female sexual dysfunction, argues that the FDA has approved 26 medications that target male sexual dysfunction but not a single drug for women.
The campaign was founded primarily to press for the federal drug agency’s approval of flibanserin, a drug purported to relieve the symptoms of hypoactive sexual desire disorder, or HSDD, the most common form of female sexual dysfunction.
However, a small band of women — some of them medical professionals — argue that Even the Score has got it all wrong. Specifically, they point out that drugs approved for male sexual dysfunction address specific physiological problems or hormonal imbalances, while flibanserin targets what is essentially a psychological issue, namely lack of sexual desire.
¨Unmet Medical Need¨?
These opponents of flibanserin and the campaign to get it approved argue that Even the Score is a thinly disguised initiative of the pharmaceuticals industry to persuade regulators and women that diminished sexual desire represents an ¨unmet medical need.¨
In a November 2014 op-ed piece posted at LATimes.com, two leaders from the opposing camp charged that the International Society for the Study of Women’s Health is largely financed by the pharmaceutical industry. It is this group that collaborated with Sprout Pharmaceuticals, the owner of the patent on flibanserin, to form not only Even the Score but also a companion group called Women Deserve.
Flibanserin Rejected Twice
This stepped-up campaign to press the FDA to approve flibanserin as the first prescription drug to treat female sexual dysfunction comes in the wake of the regulatory agency’s earlier denial of two separate petitions for approval to market the drug.
The authors of the recent op-ed piece at LATimes.com are Ellen Laan, a professor of sexuality at the University of Amsterdam in the Netherlands and a Kinsey Institute research fellow, and Leonore Tiefer, a clinical associate professor of psychiatry at the NYU School of Medicine.
New View Campaign
Tiefer is also the founder of the New View Campaign, formed in 2000 as a grassroots network. At its website, New View defines its mission as follows: ¨To challenge the distorted and oversimplified messages about sexuality that the pharmaceutical industry relies on to sell its new drugs.¨
In their op-ed, Laan and Tiefer recounted some of the testimony given at a two-day FDA hearing on female sexual dysfunction and possible drug therapies in late October 2014. Laan and Tiefer describe the FDA workshop as ¨a rowdy meeting by sedate, scientific standards.¨ They also suggested that the preponderance of the testimony presented was designed to characterize the regulatory agency’s failure to approve some sort of drug for female sexual dysfunction as ¨sexist.¨
Just a ¨Marketing Tactic¨
Although she was definitely in the minority, Tiefer herself testified at the FDA hearing in October. Mincing no words, she described Even the Score as ¨a flagrant marketing tactic disguised as a pro-woman campaign.¨ She also said she was upset ¨to hear we are committed to developing a drug, when in fact we can’t even decide what it’s for. This is not the way to do science.¨
In their op-ed, Laan and Tiefer explain that ¨as professional sexologists and advocates of women’s sexual rights, we were horrified by the campaigns’ use and abuse of the language of equality to pressure the FDA to approve a potential billion-dollar blockbuster ‘pink Viagra.’¨
Numbers Questioned
They also take issue with the oft-repeated claim that the FDA has approved 26 drugs to treat male sexual dysfunction and zero for females. Laan and Tiefer point out that most of the male drugs referred to are different versions of drugs that are very similar in composition and in how they work. They go on to assert that most of these drugs feature testosterone, ¨which an FDA advisory committee recently warned is wildly oversold to men for age-related normal changes, has serious risks, and has not been approved for sexual dysfunction.¨
As the only drug currently being offered as an answer to the lack of drug therapies for female sexual dysfunction, flibanserin differs significantly from the impotence medications and hormone replacement therapies that have won approval as treatments for men.
Differences Between Drugs
While the popular impotence drugs, such as Viagra and Cialis, work by increasing blood flow to the penis, and other male-targeted drugs help by boosting testosterone, the primary male sex hormone, flibanserin purportedly works by subtly altering brain chemistry.
Sprout Pharmaceuticals’ website explains that flibanserin increases brain levels of dopamine and norepinephrine, two neurotransmitters that have a positive effect on sexual desire. Dopamine increases levels of sexual excitement, while norepinephrine helps to control arousal and orgasm. At the same time, Sprout’s drug acts to limit levels of serotonin, ¨which can decrease desire and delay orgasm.¨
In an article posted at Philly.com, Philadelphia Inquirer staff writer Marie McCullough also points out that some of the arguments of pro-flibanserin are somewhat misleading. For example, McCullough notes that in fact the FDA has approved two treatments for female sexual problems. One is the EROS device, which is designed to increase female sexual arousal by increasing blood flow to the clitoris, and the other is Osphena, a daily pill that works hormonally to decrease the pain of intercourse.
The Numbers Game
McCullough also addresses the confusion caused by the numbers game with pro-flibanserin groups repeatedly citing the 26 drugs approved for the treatment of male sexual dysfunction. She notes that this math has been challenged by flibanserin opponents. She cites in particular a blog posting by Josh Bloom, director of pharmaceutical sciences at the American Council on Science and Health. In that blog, Bloom argues that the actual number of male sexual dysfunction medications is five or six because ¨calling a pill by a different name doesn’t make it a different drug.¨
McCullough also notes that Bloom takes issue with the inclusion of testosterone-replacement therapies among the collection of 26 drugs approved for male sexual dysfunction. Those medications are designed to treat a wide array of symptoms, including fatigue and osteoporosis, that have nothing to do with sexual function. If they are to be included, says Bloom, so too should hormone-replacement therapies for post-menopausal women.
Summing up their op-ed arguments against a gender-balanced approach to drugs for sexual function, Laan and Tiefer question the motives of the pharmaceutical industry. They write: ¨If the pharmaceutical industry were truly concerned with women’s sexual well-being, companies would market drugs that are effective for women whose sexual problems are caused by physical problems or disease, such as diabetes, multiple sclerosis and spinal cord injuries. Yet efforts to test drugs for narrow markets have been curtailed on several occasions as the industry pursued its blockbuster dreams.¨
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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