Is the little pink pill pitting science against gender politics?
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While Carmon Friedrich’s three decades of marriage haven’t all been sexless – she has 10 children – sex has been mostly a duty, a chore.
“My husband and I have been married 33 years, and I would say 30 of those years we were having difficulty connecting sexually with one another,” Friedrich said. “And the big problem was I had low sexual desire.”.
Friends told Friedrich to get some rest, take a romantic getaway and go on more date nights. None of that worked. Sexual therapy helped bring Friedrich and her husband closer, but it didn’t resuscitate her libido. At the suggestion of a therapist, Friedrich sought out medical help and was eventually diagnosed with Hypoactive Sexual Desire Disorder. Defined as a persistent lack of sexual desire, HSDD is considered the most prevalent female sexual dysfunction disorder.
Now, the drug flibanserin, billed as a pill to boost the female libido and amp up sexual satisfaction in women, has come to the forefront. After more than a decade of development, clinical trials and two previous attempts at FDA approval, the drug is on the cusp of hitting the market. Last week, an FDA advisory panel approved the pill, and the agency has until Aug. 18 to make its final decision. Many say the drug is long overdue and will address an enormous unmet need.
But the little pink pill has been mired in controversy. Even the sexual disorder it’s designed to treat has been the subject of intense debate.
In 2013, the Diagnostic and Statistical Manual of Mental Disorders removed HSDD as a disorder and adopted a new diagnosis: female sexual interest/arousal disorder, or FSIAD. This was partly because of questions regarding whether women’s sexual desire issues and arousal problems are distinct.
The prevalence of sexual dysfunction in women is also contentious. A 1992 study found 43 percent of women suffer from sexual dysfunction, but some of the questioning used in that study was later disputed. Others have suggested the number is more like one in 10.
“It’s real. There are a lot of women who have issues," said Dr. Peter Weiss, executive director of the Rodeo Drive Women’s Health Center in Beverly Hills, California.
Weiss is hearing from more of those women now, as patients ask about the “female Viagra,” the nickname for flibanserin.
Weiss is hearing from more of those women now, as patients ask about the “female Viagra,” the nickname for flibanserin.
“A lot of people are trying to claim the pink pill is the equivalent of the blue pill or Viagra for men,” Weiss said. “And it’s just not.”.
Viagra is for erectile dysfunction caused by blood flow problems; it treats a mechanical problem, not a sexual desire problem. In contrast, flibanserin was originally developed as an antidepressant – acting on a woman’s neurotransmitters – that must be taken every day.
Rather than the equivalent of the little blue pill, flibanserin represents a new class of drugs. It would be the first sexual desire pill on the market.
But flibanserin can’t shake the shorthand "female Viagra,” which may not be a bad thing for its manufacturer, Sprout Pharmaceuticals, which bought the pill from another drug company after an FDA panel unanimously rejected it over safety concerns. With flibanserin as its only drug, the pharmaceutical start-up was able to raise $50 million from investors. They’re gambling on the FDA’s decision, knowing the winnings could be huge. If approved, the drug would be the first to tap a market that some estimate would exceed $2 billion a year.
The nickname is also handy for many of the drug’s supporters, who see it as a feminist issue and equate its possible impact on the sexual lives of women to that of the birth control pill more than 50 years ago.
“This is a milestone. This is a breakthrough. We haven’t seen anything that will be as powerful as, as important, since the 1960s when the pill was introduced,” said Sally Greenberg, the executive director of the nonprofit advocacy group the National Consumers League, which has lobbied the FDA to approve the drug.
Greenberg accuses the FDA of being sexist for twice rejecting the pink pill over concerns about its efficacy and side effects like nausea, low blood pressure and faintness. In 1998, the same agency fast-tracked Viagra in six months, even though it listed stroke, blindness and death among its possible side effects.
“I don’t know what else to call that except for gender bias,” Greenberg said.
But many who work in the field of sexual health say that’s an unfair charge. Equality for women, they say, doesn’t mean the FDA should approve a drug that could possibly do more harm than good.
“You have to be concerned it is not politicized," Weiss said. "Just to say, ‘Men have Viagra and I want a pill, too,’ that’s not really the answer. So men have Viagra, fine. What issues can we do to help women?”.
Dr. Leonore Tiefer, associate professor of psychiatry at New York University, says women have been conned by the women’s rights case for the little pink pill.
"The gender equity argument was conceived in a smoke-filled backroom between public relations people, consultants and Sprout Pharmaceuticals," she said. "This was after the drug was rejected twice."
Tiefer has been a vocal critic of what she calls the “medicalizing” of female sexual dysfunction. Women’s sexual issues shouldn’t be treated with a daily dose of medication that changes the chemistry of the brain, she said, but prevented "through sexual education, through relationships that are equal."
Tiefer believes the pink pill may get approved not based on science but rather a brilliant marketing campaign by the drug’s makers.
A coalition of women and consumer groups who support the approval of flibanserin formed the online campaign Even the Score, which frames the approval in feminist terms. More than 60,000 people have signed its online petition demanding the drug get approval.
The campaign’s website also has an open letter signed by more than 60 medical professionals asking for the pill to be approved. At least a few on the list have been consultants or investigators for Sprout Pharmaceuticals.
National Consumers League.
Sprout is also a sponsor of the Even The Score campaign, but how much – if any – they contribute to it is unknown.
Another women’s health care group with ties to Sprout assisted with travel expenses for women who traveled to the FDA advisory conference on flibanserin last October, sharing their stories of living with sexual dysfunction. It’s unclear if they also paid for the expenses of women who traveled to last week’s advisory hearing, which voted to recommend approval of the drug.
"We are in a moment in time of women’s sexual emancipation, where the opportunities are being hijacked by an industry that are really not interested in a women’s well-being," said Tiefer. "They are interested in financial opportunities that they have."
Greenberg acknowledges that Sprout could make great money off the drug; that’s what happens, she says, when a company delivers a product that consumers want. And the charges of sexism against the FDA? Greenberg says that’s just good advocacy.
"I will say they’re incompetent, I will say they’re idiots, I will say they’re not doing their jobs, when it’s patently obvious that there is a way to fix something or treat something and a federal agency doesn’t do the job that it’s set up to do," she said. "It’s good advocacy and it needed to be done."
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FDA panel backs approval of ‘female Viagra’
Panel of government experts vote to back flibanserin to treat low libido in women; FDA decision expected in August.
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