Sex<\/a>, Drugs & Who Has Control demonstrates, the road to get flibanserin \u2013 often called, somewhat derisively, \u201cthe female Viagra\u201d \u2013 to women struggling with their libido was anything but obvious, strewn with regulatory roadblocks, pharmaceutical price-gouging, sexist double standards and a profound societal disinterest in female choice, pleasure and experience.<\/p>\nThough the US Food and Drug Administration (FDA) approved flibanserin, sold under the name Addyi, for premenopausal women suffering from Hypoactive Sexual Desire Disorder (HSDD) back in August 2015 (and, as of last December, for women post menopause) most women are not aware that a drug for female sexual desire exists, let alone that it\u2019s available. Until she was approached about making the film, \u201cI had never heard of this drug,\u201d Aisling Chin-Yee, the director, said. \u201cI had never even thought about going in and talking to my doctor about my sex life. The only thing I\u2019ve ever been asked by a doctor is, am I having sex or am I not having sex? And whatever answer I gave always seemed like the wrong answer.\u201d<\/p>\n
The Pink Pill examines just how persistent that disinterest in female sexuality, beyond reproduction, runs throughout the US medical establishment. As several sexual health doctors, gynecologists and urologists attest, most medical school curricula do not include sections on female sexual health, libido or clitoral anatomy. When Viagra was introduced in 1998, the medical establishment quickly adopted a drug that was seen as a breakthrough treatment for a physical issue in men. But the conversation around female libido and orgasm remained stagnant, often starting and ending with \u201cit\u2019s complicated\u201d.<\/p>\n
Frustration with this apathy and her own disappeared desire led Cindy Eckert, a pharmaceutical entrepreneur based in Raleigh, North Carolina, to buy flibanserin for $5m in 2011, after Boehringer Ingelheim decided not to fight for FDA approval. A hyper-feminine, distinctly 2010s entrepreneur with a fondness for everything magenta, Eckert renamed the drug Addyi after Dr Addison Grey, Kate Walsh\u2019s character on the popular medical drama Grey\u2019s Anatomy who represented the drug\u2019s ethos of, as she says, \u201cwomen living life on their own terms\u201d. Her company, Sprout Pharmaceuticals, completed the necessary trials, demonstrating that Addyi improved the sexual drive and experiences of women struggling with HSDD. By October 2013, it was ready to go to market, subject to FDA approval. Though Addyi works on neurotransmitters in the brain, akin to an antidepressant, the FDA assigned its review to its urology division \u2013 a better fit for Viagra, which relaxes muscles and increases blood flow to the male genitalia. The FDA rejected it, claiming that the side effects \u2013 namely dizziness, nausea, fatigue and low blood pressure \u2013 did not outweigh the benefits.<\/p>\n
The question of side effects \u2013 essentially, why would desire be worth it for women? \u2013 continued to dog the medication as it sought regulatory. The Pink Pill amasses a significant recent history archive of the \u201cfemale Viagra\u2019s\u201d role in the culture wars of the 2010s, as Sprout mounted an aggressive lobbying campaign ahead of its 2015 hearing. Some of the backlash was predictably patronizing: \u201cYou might know [flibanserin] by its old name \u2013 wine,\u201d joked Jimmy Fallon on The Tonight Show. Some was more grounded, such as pushback from those who believed HSDD to be a fictional condition to guilt women for their lack of sex drive, low libido medicalized in the name of pharmaceutical profit, with no medical consensus on what constitutes \u201cnormal\u201d sexual desire.<\/p>\n
The FDA questioned the potential for sedative effects, wondering if \u201ca woman might take flibanserin the night before and get up the next morning and fall asleep taking her kids to school\u201d, recalls Dr Anita Clayton, a University of Virginia psychiatrist and consultant to Addyi, in the film. \u201cThere was a very paternalistic attitude.\u201d Data showing an increase of one \u201csuccessful sexual event\u201d per month was dismissed as ineffective \u2013 even though women with untreated HSDD experienced maybe one or two such events a year.<\/p>\n
The bias showing through the FDA approval process boiled down to \u201cwell, we just don\u2019t know if [Addyi] is necessary\u2019\u201d, said Chin-Yee. \u201cBut that\u2019s not a question that has ever come up when it comes to male sexual dysfunction. It is absolutely imperative that if you are a man with a penis, you should be able to do whatever you want with it. And those were not the same considerations for women.\u201d (The FDA, which denied any accusations of gender bias, did not respond to the film-makers\u2019 interview requests. \u201cI will give the benefit of the doubt to the FDA that they were in the midst of like getting Doge-ed,\u201d Chin-Yee said, referring to the Elon Musk-led consolidation that gutted the department.)<\/p>\n
Never mind that many women wanted their desire back, and felt less whole without it. \u201cI thought \u2018well, after you have kids, that goes away \u2026\u2019\u201d says one HSDD patient in the film, frustrated by her lack of options and a prevailing narrative that \u201cyou\u2019re a mother now and you focus on these things. That\u2019s behind you.\u201d The loss of sexual desire was \u201cdevastating\u201d, says another whose menopause torched her formerly steady libido. \u201cI felt like someone had slayed me.\u201d Both Gattuso and her daughter testified at the FDA\u2019s public hearing on the drug\u2019s approval, speaking emotionally about the toll their diminished libido had taken on their lives. Opponents of the drug put the onus back on them; one recommended they instead try what worked for her: \u201cswitching boyfriends, chocolate, coffee, certain episodes of Grey\u2019s Anatomy, pornography, upgrading my vibrator, read Fifty Shades of Grey, a removable shower-head and an acceptance of myself and the libido I came with\u201d.<\/p>\n
Photograph: Paramount<\/p>\n
After much heated back and forth, the FDA approved Addyi in 2015. Eckert subsequently sold Sprout to pharma giant Valeant for $1bn. But the victory came with a major caveat: a black box warning, the most serious level available, for side effects such as dizziness, nausea and headache. Doctors had to take a test to prescribe it. Pharmacists had to take a test to fill it. Women<\/a> prescribed Addyi had to sign a pledge that they would not drink alcohol. (Viagra, on the other hand, came with a recommendation that one merely should avoid alcohol.)<\/p>\nFaced with declining sales, Valeant more than doubled the price of Addyi, to $800 a prescription, making the drug cost-prohibitive. Then, in 2017, they shelved it altogether. What had once been the promising frontier in female sexual health was now essentially locked away. \u201cHow can you possibly pass something that is so wonderful for women and then have it ripped out?\u201d says Gattuso in the film. \u201cAfter all of this work, all of this emotion, we\u2019re down to square one again. And we still are.\u201d<\/p>\n
Eckert managed to buy Addyi back from Valeant and start over. The drug is back on the market \u2013 though, if you google it, the first thing you will read is still a bold warning about side effects. Addyi proponents see a seriously stubborn double standard. There are 26 drugs approved for male sexual dysfunction, Chin-Yee noted, in part because no drug fits all. \u201cThat\u2019s obvious, but for this drug and for women, it\u2019s like, \u2018well, if this could be a potential side effect, then the risk isn\u2019t worth the benefit,\u2019\u201d she said. \u201cAnd the benefit is only that women might enjoy their sex better. You know how many drugs come with nausea and dizziness and headaches? Those are things that pretty much every drug has on the side of their box.\u201d<\/p>\n
The through line, she emphasized, is choice. \u201cYou should be able to have that discussion with your own body and your own physician, rather than somebody just removing it as an option for you.\u201d The film puts that pursuit of pleasure in context with a very different medical landscape than when Addyi first premiered, a post-Roe world in which women\u2019s reproductive rights are under assault, healthcare for trans people is criminalized and bodily autonomy across the board remains tenuous.<\/p>\n
Whether for abortion or orgasm, there\u2019s nothing diminutive or inconsequential about choice, the film concludes. \u201cYou might think it\u2019s funny and frivolous to say that women enjoying sex with their husbands is necessary,\u201d said Chin-Yee. \u201cBut it is exactly that right being taken away that is related to all the other rights that could be taken away from you, and are being removed in the United States right now.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Barbara Gattuso had been happily married for decades when she signed up, in the late 2000s, for a…\n","protected":false},"author":2,"featured_media":333715,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27],"tags":[93,61,60,270],"class_list":{"0":"post-333714","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-movies","8":"tag-entertainment","9":"tag-ie","10":"tag-ireland","11":"tag-movies"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/333714","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=333714"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/333714\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/333715"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=333714"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=333714"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=333714"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}