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The “Female Viagra” Is Here: The Story Of How It Almost Never Happened.
Update, 8/18: The FDA announced its approval of flibanserin, the first drug to treat sexual desire disorder this evening. The drug will be sold with strong warnings about interactions with alcohol and other precautions to try to limit misuse. Read the original story below.
In 1998, Viagra was approved as the first drug to treat male sexual dysfunction. Today, while men have a total of 26 drugs that can help them, a woman struggling in bed is still out of luck in the pill department.
That could change today. Following years of controversy, the FDA will announce on whether it will approve the very first libido-boosting drug for women suffering from a condition called hypoactive sexual desire disorder (HSDD), which can affect about 1 in 10 women. Women who have HSDD don’t have sexual fantasies or desire sexual activity–and suffer psychologically for it. Their symptoms also can’t be explained by another obvious condition, like depression or drug addiction.
If it’s approved, as an FDA advisory committee recommended in June, it would be a milestone for a relatively small startup company that bet on developing the drug in 2011. Whether the desire-enhancing pill would be a milestone for women is much more questionable. Among both feminists and women’s health experts, the drug still has as many critics as it has supporters.
The drug, called flibanserin, works by rebalancing the levels of three neurotransmitters in the brain. It was first developed as an antidepressant for both sexes, but that didn’t pan out in testing. Its developer, the large drugmaker Boehringer Ingelheim, instead pursued one of its side effects–a boost in sexual desire–instead. However, by 2010, the “pink pill” hit a wall when the FDA declined to approve it. The agency said more work was needed to characterize safety and show it was effective enough to justify its side effects, which included low blood pressure, fainting, nausea, and fatigue. Rather than keep going, the German pharmaceutical company canceled the project outright.
Boehringer Ingelheim wasn’t the first drugmaker to bow out of the potentially lucrative quest for a female libido drug. Others, including Viagra’s maker Pfizer, Procter and Gamble, and BioSante Pharmaceuticals, have tried and failed. They all quickly learned that when it comes to sexual dysfunction, a pharmaceutical fix was much easier in a man than a woman. Viagra and other drugs like it are taken before sex and increase physical blood flow to the penis (of the 26 FDA-approved male impotence treatments, many are variations of the same one). The so-called “female Viagra” isn’t anything similar at all: It must be taken every day and messes with complicated systems of brain chemistry. And the very premise that women should turn to a drug to alter their desire, which is naturally prone to fluctuate in life, has drawn critics’ ire.
When flibanserin was sidelined, Cindy Whitehead, together with her husband Bob Whitehead, were leading a pharmaceutical company that sold testosterone treatments for men. At that year’s meeting of the Sexual Medicine Society, according to Whitehead, people involved in the research were looking for new investors to continue the work. Some patients in the clinical trial had been responding well and didn’t want the pill abandoned. The Whiteheads considered it for a year and, at the urging of colleagues, including Viagra’s creator Irwin Goldstein, decided to sell off their profitable business and buy the rights to the drug. They formed a small 25-person team at Sprout Pharmaceuticals to pick up where the other company left off.
Cindy Whitehead, CEO of Sprout.
“It became a cause for me,” Cindy Whitehead, the CEO of Sprout, the company that formed to push the drug to market, says. “I really felt that the reason that they were walking away was, in fact, because of a societal narrative that has frankly gone on for too long. It’s that which reduces all things in the bedroom for men to biology … and all things in the bedroom for women to psychology. The truth is we both bring both things into the bedroom, and women were being completely underserved in having no biological treatment options.”
The path from five years ago to today was not at all straightforward. Backed by private investors, the company has spent the last few years addressing the FDA’s concerns about the drug, including additional testing on 3,000 patients in 14 new clinical studies that further addressed both its efficacy and side effects (in addition to the 8,000 women who had already been part of past trials, making it the largest application for a woman’s health drug ever). In the end, for pre-menopausal women (average age: 36), these studies showed that the drug increased a woman’s desire, led to more frequent satisfying sex, and decreased “distress” about lost sexual desire. But the trials also showed it was far from a miracle sex drug. On average, women on the drug had 0.5 to 1 additional sexually satisfying events per month (from a 2 to 3 “event” baseline) compare to those on a placebo. Only 10% to 12% responded at all.
Sprout resubmitted its new drug application in 2013, but the FDA said even more additional safety studies would be needed. After that, Sprout decided to pursue the little-chosen path of challenging the agency’s decision. That’s when media attention around the drug exploded. “The world woke up and started watching,” says Whitehead.
From birth control to hormone replacement therapy, the history of drugs for women’s sexual health is highly politicized. Flibanserin is no exception. Members of Congress and a dozen advocacy groups, including the National Organization of Women and the Association for Reproductive Health Professionals, began lobbying the FDA to approve the drug.
Most controversially, the campaign framed the FDA’s decisions in gender justice terms. The campaign noted that erectile dysfunction drugs like Viagra and Cialis also come with even more serious health risks, such as seizures and strokes, not to mention the four-hour erection that requires medical attention that’s often mentioned in commercials.
“I think there’s been some unconscious bias at the FDA and an overly protective mentality about the risks women are allowed to undertake when it comes to sexual health, especially compared to men,” says Sally Greenberg, executive director of the National Consumer’s League, one of the organizations that has led the “Even the Score” campaign. Greenberg says it has been the advocacy groups that have led the campaign’s efforts, not Sprout–as critics have charged–though the pharma company has given some funding and assistance. She doesn’t think Sprout’s drug should be the end-all of libido drugs for women, “but if you don’t get something passed the FDA’s gates, other companies aren’t going to follow.”
Not all feminists agree, and for that matter, neither do all health experts. Opponents say the company is co-opting a feminist agenda in the name of profit. Sexual health activist and NYU psychiatrist Leonore Tiefe has been campaigning for years against the pharmaceutical industry’s quest to train people to think all sexual problems are medical issues, requiring expensive medicines to cure. She calls “pink” Viagra the sham drug of the year. And a July 13 letter to the FDA signed by 200 women’s and sexual health experts, psychologists, and ethicists opposes Sprout’s “carefully orchestrated public relations campaign” and the dangerous precedent of approving a chronic use drug with a “poor risk-benefit profile,” as well as unclear data about whether it’s safe with alcohol. They also worry about off-label use of a serious, daily drug by women who don’t actually have HSDD, and are simply bored with their spouses, depressed, or are having relationship problems better suited to therapy.
And HSDD itself is murky. Hypoactive sexual desire disorder was always hard to diagnose. But the American Psychiatric Association entirely removed HSDD from its diagnostic manual in 2013 and replaced it with a new diagnosis that focuses on arousal and desire as a much more complicated feedback loop. Basically, the pink pill may be treating healthy women with no disorder at all, says Laurie Mintz, a psychologist at the University of Florida and author of A Tired Woman’s Guide To Passionate Sex .
“There is very very good science that indicates having low spontaneous desire, aka [not] ‘feeling horny,’ is actually not a medical problem at all. What’s actually the problem is that once sexual activity begins, when someone can’t get aroused,” says Mintz. “[Sprout’s] outcome is sexual desire, not arousal.” She fears that the drug’s approval will encourage women to pop pills they don’t need, rather than try safer desire-boosting remedies without side effects, like therapy or reading erotica.
When Whitehead speaks about her drug’s potential, she talks with passion about women who have broken down in tears knowing that their lack of interest in sex is driving a wedge between them and their partners. She meets women who fear their partners will leave them and those who blame themselves for their troubles. The company’s fundamental position is that the data is all in–there’s some benefit, there’s some side effects, and the decision should be left to women. Sprout’s plan is to include information on the bottle that if the drug isn’t working within eight weeks, it’s probably not right for the patient. As for its relatively modest effect, she says women who have HSDD aren’t generally looking to put their sex drive into hyper mode–to them, a small improvement in their sex drive is often very meaningful.
If the FDA does approve the drug, she believes, it’s going to be the beginning of a more “logical” conversation about sex. Like depression, sexual dysfunction will be a problem for which both therapy and pills are available. As for the business potential? If the FDA gives its approval, Sprout has a specialty salesforce of about 200 that are ready to start pushing the drug. “I think whether or not this is ultimately the right choice for women is a story that will be told in the marketplace.”