Is "Female Viagra" a Real Thing? FDA to Rule on Drug Marketed as Libido-Lifter

This week the US Food and Drug Administration (FDA) will consider approving a drug that purports to treat female sexual dysfunction amid a campaign funded largely by pharmaceutical companies alleging the FDA has a gender bias when it comes to approving sexual dysfunction drugs.

The potential approval raises two important questions: First, is there really a medical need for it? And second, has the pharmaceutical industry created a medical problem in order to sell a potentially lucrative cure?

The female sexual dysfunction treatment drug is called flibanserin, and was first developed as an anti-depressant. Now, it is being marketed as a cure for Hypoactive Sexual Desire Disorder (HSDD), which the drug's makers describe as distressingly low sexual desire. The FDA will consider approving the drug on Thursday.

The FDA rejected flibanserin twice before: The first time, in 2010, the federal agency rejected an application from then-owner, German pharmaceutical giant Boehringer Ingelheim, because it said the effectiveness of the drug was not sufficiently robust to justify the risks, which include sleepiness, nausea, and fainting.

The current owner, Raleigh, North Carolina-based Sprout Pharmaceutical, purchased the drug in 2010 from Boehringer Ingelheim and reapplied for FDA approval in 2013. Again, the FDA rejected the application.

Now, Sprout has helped launch a public relations campaign arguing that the FDA needs to approve a drug for women's sexual dysfunction, 17 years after the agency first approved one for men, the blockbuster success Viagra.

But critics say the comparison to Viagra is misleading.

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Sprout and other pharmaceutical companies are funding a public relations campaign called Even the Score, which accuses the FDA of gender bias and that likens flibanserin to Viagra. The campaign claims that there are 26 FDA-approved drugs to treat sexual dysfunctions in men, but "not a single one for women's most common sexual complaint."

But the statement is problematic: first, there are only eight FDA-approved drugs to treat erectile dysfunction, and another 32 testosterone drugs not approved for use in sexual dysfunction.

Neither Viagra nor testosterone are comparable to flibanserin: testosterone is not approved to treat sexual dysfunction and Viagra treats erectile dysfunction, not low desire.

Further, critics of the drug contend that decreased interest in sex is usually psychological, social, and relational, not medical, and that Sprout is creating a medical problem where there is none to try and make a fortune, a la the makers of Viagra.

"Why is it that none of these drugs have shown strong results in terms of efficacy? I think it's because you can shift biology but if everything else, the whole context around one's sex life remains the same, and that will still be the same primary influence on desire," Thea Cacchioni, a sociologist at the University of Victoria and outspoken critic of flebanserin, told VICE News.

The diagnosis of Hypoactive Sexual Desire Disorder was removed from the DSM-5 and instead combined with low arousal, forming a new disorder with symptoms including absent or decreased sexual interest and erotic thoughts or fantasies, and absent or decreased initiation of sex, responsiveness to a partner's initiation of it, excitement and pleasure, response to sexual cues, and sensations during sexual activity.

Put simply, the disorder is present if a woman has lost interest in sex.

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Sprout Pharmaceuticals, the maker of flibanserin, argues that decreased interest in sex is a medical problem, seen in neuroimaging studies when women with the illness show no reaction in their prefrontal cortex to erotic images. The drug will solve the problem by increasing two chemicals responsible for an excited sexual response — dopamine and norepinephrine, and limiting serotonin, which controls inhibition, according to Cindy Whitehead, CEO of Sprout.

"We were required to look at whether it was meaningful, whether the patients saw the effect to be meaningful," Whitehead told VICE News. "The effect from flebonsirin is modest, but the goal is modest. The goal is not to make her hypersexual, we don't want to take desire and catapult it. It's really a restoration…to their own normal level."

Critics including Cacchioni and pharamacologist Adriane Fugh-Berman said that Sprout's own data showed it was not effective, adding that it would only improve sexually satisfying events by less than 1 per month, or eight per year.

"Not being able to have an orgasm or pain and discomfort during intercourse are probably more common problems, and this drug won't do anything for those," Fugh-Berman said.

Dr. James Simon, an investigator who worked for Sprout on flebanserin, said the diagnosis is a specific medical problem, not just run-of-the-mill relationship problems that lead to difficulty having sex.

"I have a great deal of sympathy and empathy for these women, they are basically normal…women, and for whatever reason, and I don't really believe we know, kind of a switch goes off, what was a normal level of spontaneous sexual thoughts and fantasies, is gone," Simon said.

Whitehead said much of the "invented controversy" about whether female sexual dysfunction was a real medical problem in need of treatment is analogous to how society used to treat depression as something normal and routine to be dealt with on one's own.

"Maybe before we understood brain chemical imbalance we thought life is tough, suck it up. I think unfortunately that's where we've been with [Hypoactive Sexual Desire Disorder]," she said.

Whitehead contests the drug will help women with a real condition that has been recognized for decades.

Critics of the drug aren't so sure.

"There's a lot of controversy in the DSM about sexuality, let's just start with that," Leonore Tiefer, a psychologist at the New York University School of Medicine and an outspoken critic of flibanserin, told VICE News.

"I've written about this since the 80s, and it's a mess. Start with homosexuality, which was in there and then voted out, and you see that the DSM has become the poster child for questionable science in terms of nomenclature issues," she said.

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"The whole area of psychiatry is hard to diagnose because it doesn't have the kind of biomarkers and clear-cut outcome variables that you have in urinary tract infections. It's a whole different ball game. It's very subjective. How do you measure changes in depression, in anxiety, in sexual satisfaction? It's a roving target," Tiefer said.

Sprout was created in 2011 by Bob and Cindy Whitehead in order to try to bring flibanserin to the market. The couple had previously owned another small pharmaceutical company, Slate Pharmaceutical, which sold a testosterone pellet called Testopel, which is approved for use in hypogonadism.

In 2010, Slate Pharmaceutical received a warning letter from the FDA for advertising unapproved uses for Testopel, including depression and erectile dysfunction, and unsubstantiated superiority claims for the pellet. The advertisements promised "improved mood, increased sexual interest, restoration of erectile function, increased muscle mass, increased strength of bones."

The couple sold Slate in 2011, the same year they bought flibanserin and created Sprout Pharmaceutical to focus on it. Both Slate and Sprout are funded by private investors, with Sprout now boasting $50 million in funding.

The Whiteheads bought flibanserin for an undisclosed price from German pharmaceutical giant Boehringer Ingelheim after that company planned to shelve the drug following a rejection from the FDA, according to Simon, who also worked on flibanserin at Boehringer Ingelheim before it was sold to Sprout.

After flibanserin's intial rejection from the FDA under Sprout's ownership, the company joined with a group of organizations to form a public relations campaign called Even the Score, which accused the FDA of gender bias in its decision to reject female sexual dysfunction drugs. The group put together a robust web and social media presence, including a petition for women to sign to demand equal treatment from the FDA.

According to the New York Times, Sprout hired the former head of the FDA's office of women's health, Audrey Sheppard, as a consultant, and Sheppard then worked to bring together Sprout and Washington, DC-based activist groups, who together then launched the Even the Score campaign.

Even the Score also worked on Capitol Hill to drum up support for the campaign among Congress members, the group told VICE News. Cindy Whitehead also made modest contributions to the Democratic Party; in 2014, she donated $32,400 to the Democratic Congressional Campaign Committee.

Fifteen Democratic Congress members have since signed letters sent to the FDA urging the agency to act fairly in its approval process of female sexual dysfunction drugs.

"We believe approval of a drug to treat Female Sexual Dysfunction that women could access can have a beneficial impact on the lives of millions of American women and men," read one letter, signed by Congresswomen Debbie Wasserman Schultz, Chellie Pingree, Nita Lowey and Louise Slaughter.

The political pressure seemed to have worked in some ways: since the drug's first appearance before the FDA, the agency made "female sexual dysfunction" one of its top 20 priorities of diseases to hold public hearings on, alongside illnesses such as lung cancer, fibromyalgia, HIV, and breast cancer. The FDA said it chose those priorities after taking public comments about critical challenges facing significant populations with limited treatment options.

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"I think it's unprecedented that the FDA has gotten this kind of public relations pressure," said Fugh-Berman, who runs a research project at Georgetown called Pharmed Out, which studies the pharmaceutical industry's influence in Washington.

"This is unusual. This company is small but incredibly aggressive in PR," she said.

At the public hearing on flebanserin in October, 2014, Sprout and Even the Score arranged for patients with the disorder to arrive at the hearing by bus, where they were greeted with goody bags from corporate sponsors, wore matching pins, and testified about equal access to sexual dysfunction drugs, according to Whitehead.

Opponents of the drug have been nearly as vocal and organized, appearing at hearings to testify that the drug is unnecessary.

"Even the Score is very clever, it has grassroots look to it, it's very good at convincing people this is a case of sexism. But if you look at facts, the FDA is actually protecting women," said University of Victoria sociologist and outspoken critic of flebanserin Thea Cacchioni.

Cacchioni praised the FDA for so far rejecting the drug based on data about its safety and effectiveness, but criticized the agency for buckling to pressure for even considering female sexual dysfunction as a high-priority disease. She said Sprout has created a "media circus" around the issue.

Whitehead said she was optimistic about the FDA's coming decision, and believed that Sprout had met all of the requirements the FDA had asked of them in conversations at the end of 2014. She would not speculate about whether they would resubmit the drug again if it were again rejected by the agency.

Follow Colleen Curry on Twitter: @currycolleen

Watch the VICE News documentary, "Sex, Slavery, and Drugs in Bangladesh."

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