Image: Sprout Pharmaceuticals

'Pink Viagra' Is Coming to Solve a Problem That May Not Exist

The new pill won’t address the majority of women’s issues with sex.

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Jul 3 2015, 2:00pm

Image: Sprout Pharmaceuticals

What makes sex good? An orgasm? Both parties being into it? Just getting some at all?

For one of the women who testified in an FDA panel on sexual dysfunction, successful sex is when her husband has fun. Katherine, who was only identified by her first name, said she has "no expectations" when it comes to sex, as she only does it "out of obligation." Carol said she just wants to be able to get through it without crying. Beverly said she'd spent $35,000 on different medical treatments, a testament to her efforts to fix the problem of her supposedly dysfunctional sex drive.

Though all the women testifying at the meeting last October described different anxieties about sex, they were all diagnosed with the same thing: female sexual interest/arousal disorder (FSIAD). Ten years ago, this diagnosis didn't exist, and many experts are skeptical that the disorder itself exists today—or that it can be treated with modern medicine.

Regardless, Sprout Pharmaceuticals—which you may remember as the maker of Testopel, the implantable testosterone pellet that might just give you breasts—wants to sell you the holy grail of sexual dysfunction drugs: a "Viagra for women" or "pink Viagra."

The two pills are distinguishable by more than color. Unlike Viagra, which increases blood flow to the penis to sustain an otherwise unlikely erection, flibanserin—or Addiyi, as it would be marketed to consumers—alters a woman's brain chemistry. Apparently though, not significantly enough to get it approved by the FDA to treat depression, the application for which it was initially developed by German pharmaceutical company Boehringer Ingelheim.

"It was only 150 years ago that doctors were telling us if we had frequent desire there was something wrong with us. Now if we don't have desire there's something wrong with us."

While flibanserin's predecessor failed as an antidepressant, a few women reported they felt more sexual desire during clinical trials. Sprout jumped on the chance to corner this wide-open market and bought the rights to flibanserin in 2012. The company has branded it as a treatment for HSDD or hypoactive sexual desire disorder, an old classification of FSIAD that psychiatrists no longer even use.

Though this so-called feminist wonder drug has already been rejected by the FDA twice for being ineffective, and because users reported a high rate of side effects and drug interactions, there are some indications that Sprout might finally get its way and be granted a green light to sell flibanserin to the general public as early as this August. In the latest FDA report, an advisory committee said female sexual dysfunction was "clearly an area of unmet medical need" and voted 18 to 6 to recommend its approval, although the FDA admitted in the report that it doesn't know how flibanserin works to treat this disorder that may not exist.

"It was very distressing that we start off this meeting saying we are committed to developing a drug when, in fact, we can't even agree what it is for," Dr. Leonore Tiefer, a psychiatrist with the NYU School of Medicine, told the panel.

Some are attributing the FDA's newfound acceptance of flibanserin to an aggressive marketing campaign orchestrated by Sprout that accused the FDA of sexism. In one article, Dr. Anita Clayton, who is a paid consultant for Sprout and seven other pharmaceutical companies, claimed that fast-tracking drugs like Viagra while withholding flibanserin undermines the importance of women's sexual health.

"There's some concern about bias on the part of the FDA," said Dr. Clayton in an interview. "There was something going on for female sexual dysfunction that wasn't happening with male sexual dysfunction."

Image: Sprout Pharmaceuticals

Even the Score, a lobbyist group partially funded by Trimel Pharmaceuticals and Sprout Pharmaceuticals, became the most vocal champion of this perspective. Its website calls sex "a basic human right" and says "we must act for the 1 in 10 women, couples, and ultimately families affected by this issue." Even the Score says there are 26 drugs for sexual dysfunction in men and none for women—but its list for men includes different dosages of the same drug, and some medications that haven't been approved specifically to treat sexual dysfunction. Even the Score did not immediately respond to request for comment.

The Even the Score campaign wasn't meant to pressure the FDA, but just to raise public awareness of an unmet medical need, Cindy Whitehead, Sprout's CEO, told the Wall Street Journal last year.

Given that the medical and psychological industries have spent centuries convincing women that sexual desire was a symptom of their hysteria, an actual medical diagnosis until 1980, or their "uterine fury," it's ironic that today any woman who has a disinterest in sex can be deemed mentally ill—and that those who disagree can be labeled sexist.

"Norms of desire vary from era to era and culture to culture," said women's studies professor and sociologist Thea Cacchioni, who's written about her experience testifying at the FDA hearings on flibanserin. "It was only 150 years ago that doctors were telling us if we had frequent desire there was something wrong with us. Now if we don't have desire there's something wrong with us."

According to Dr. Rosemary Basson, a clinical professor and director of the University of British Columbia's school of sexual medicine who sat on the FDA's scientific panel at the meeting in October, having low desire is normal.

"It's what all of us in the normal world with busy lives are experiencing," Basson said.

While it's undoubtedly problematic if it's impossible for a woman to ever become aroused, it's likely that such extreme cases have to do more with physiological ailments, mental health, or relationship issues; being constantly desirous of one's partner is an unrealistic expectation.

The idea that a drug like this would advance feminism or women's health "has not been supported in any feminist academic literature ever"

"I've provided references to the fact that the opposite is true—that sexually satisfied women, when they're surveyed, will say it's rare to actually sense desire other than during an experience," Basson said.

If you can feel satisfied without this constant desire, then it cannot be a dysfunction, she said.

While sexual dysfunction in men is characterised by the inability to get a boner, its female counterpart is characterized in the DSM, the American Psychiatric Association's official catalogue of mental disorders, as a lack of interest or fantasies that result in a difficulty getting turned on.

It was once thought that Viagra might work for women too, just by sending blood down south, and some doctors still prescribe it, though without much success. As one patient, Karen, who tried Viagra said at the panel, "The only thing that got swollen were my sinuses."

In clinical trials, Sprout measured flibanserin's effectiveness with three markers—the number of times a woman had satisfying sex every month, the distress she felt about her sex life, and her overall desire for sex. The drug was only tested on women in long-term heterosexual relationships.

Compared to a placebo, flibanserin increased the number of "sexually satisfying events" the women in the trial had by an average of 0.5 to one per month, over a median of two or three per month. Their reported distress about sex went down by an average of about 10 percent.

So it might only make you cum 0.5 more times per month—but hey, you'll also be 10 percent less worried about it!

In terms of overall desire, which is cited as the problem in most dysfunctional women, the FDA and Sprout couldn't agree on how to measure it. When women recorded their thirst for action in a daily diary, flibanserin showed no improvement over a placebo. When women answered questions after a 28-day period that ranked their desire on a scale of 1.2 to 6.0, flibanserin showed an average improvement of 0.3 to 0.4. On top of any drug's placebo effect, these trials arguably could have had the same effect as sex therapy, since women had to make sex a priority, think about it on a daily basis, and record their feelings about it.

Obviously ranking something as subjective as sexual desire on a 6-point scale is problematic, as is characterizing all women who don't constantly want sex as mentally ill. Ideas about sex and desire are socially constructed and there are many reasons why women might not be that into sex at any given moment.

On top of flibanserin's questionable efficacy, the studies also uncovered side effects. US News and World Report reported in 2010 that "about 15 percent of flibanserin users in the experimental trial stopped taking the drug because of bad reactions like dizziness, nausea, anxiety and insomnia, compared to 7 percent of the placebo users." These risks were amplified when flibanserin was mixed with alcohol, which will be listed as a no-no on the warning label. Perhaps most troublingly, Sprout only tested that on 25 people—23 of whom were men. What a curious way to study a drug being developed for a dysfunction that only affects women.

"If he wants sex and I give it to him, then yes, I was a good wife today."

Also cause for concern is that the women who may be more likely to give in to the powers of persuasion of flibanserin marketing are also the kind of women who might attempt to mediate nervousness about sex with alcohol.

"Women with sexual difficulties will often say, 'The only way I can agree to this is if I've had a couple of drinks. So the fact that it's not to be mixed with alcohol is a huge worry," she said.

For Cacchioni, Even the Score was the most frustrating part of this whole circus, calling their accusations "an appropriation of feminism for a commercial purpose." The idea that a drug like this would advance feminism or women's health "has not been supported in any feminist academic literature ever," she said. "Quite the contrary, among feminist academics and people working in health and sexuality . . . the understanding is that the drug industry has created very unsafe and ineffective drugs for women for a long time."

In her own research, even women who blame their low desire on biology and seek medical help admit they struggle with society's expectations of them, said Cacchioni.

"As much as they tried to blame their bodies . . . what came out in interviews is that they had a really hard time with heterosexual norms today," she said. "They talked about . . . this negative influence of Hollywood, their negative early experiences with sexuality, the way their partners were really hard on them if they didn't live up to certain sexual ideals, and the shame they felt even with their girlfriends in talking about sex if they weren't really that into it."

Of the women suffering from low sexual desire who spoke at the FDA panel, all were adamant that they didn't have any personal or relationship issues that could be causing their problem. But one woman said she learned at a young age not to initiate sex because her boyfriends shamed her when she did. Another had to have her uterus and ovaries removed at age 35 because of damage done to her body by the Dalkon Shield (an IUD she said was advertised to her as 100 percent safe, "the Cadillac of contraceptives"). Multiple women said they avoid alone time with their husbands at all costs. Carol could only describe how she feels when her husband initiates sex with a loud sigh. Again, all were sure that the problem is strictly biological.

"There are many social, interpersonal, economic reasons why women may have low desire and there's very, very little if any evidence to show it's a result of a faulty internal mechanism, especially in relation to brain chemistry," Cacchioni said. Telling women that there's something wrong with them, and that a pill will make them want to have sex with their partners— and could even save their relationship—won't fix these underlying problems. "It's going to play on the insecurities of so many women," Cacchioni said.

It wouldn't be the first time Sprout played on heterosexual norms to sell drugs. In 2010, the FDA reprimanded Slate Pharmaceuticals (what Sprout used to be called) for violating rules with a marketing campaign for a testosterone treatment, Testopel. If you don't remember those manly "Is it Low T?" ads, men described their ailments—ranging from HIV to only being able to do five push-ups—and raved about how Testopel helped them. The FDA warning said that Slate's pamphlets, website, and videos promoted unapproved uses of Testopel, omitted and minimized important risk information, overstated its efficacy, presented unsubstantiated superiority claims, left out material facts, presented misleading convenience claims, and encouraged an unapproved dosing regimen. The warning went on the say that the FDA was "extremely concerned by the breadth and scope of violations."

Interestingly enough, a few women at the FDA panel on flibanserin were using testosterone to increase their libido. Two even said they had testosterone pellets inserted. The treatment is supposed to last six months, but Beverly said she sometimes returns to the doctor after only two or four months if she's feeling less interested in sex. "When I'm not interested in his advances," she said of her husband, "it becomes very clear that the pellet that's inserted in me must be wearing off." So she just wants a pill she can take every day that will never wear off. Another woman at the panel said of her husband, "If he wants sex and I give it to him, then yes, I was a good wife today."

If Sprout's plan to "even the score" in sex is giving men more entitlement to demand sex whenever they want it—and women less room to say no, flibanserin is no health care solution. And it certainly isn't feminist.

This article is part of Bodies of the Future, a collaboration between Motherboard and LadyBits. Follow LadyBits on Twitter and Facebook.