BROOKE: And I’m Brooke Gladstone.

It was revolutionary. It was a game-changer. It was blue. But for the last week, TV news would have you believe it’s now even prettier... in pink.

 [clip montage]

 ... female Viagra, the little pink pill as it’s also known, is the first official drug to boost sexual desire in women.

... some call the female Viagra. Now these are the pills many think will revolutionize the treatment of women with low sex drive.\.

 It’s known as the female Viagra, and many say it will be a game-changer for women.

Female Viagra. Why supporters of the drug argue it would be sexist not to approve this pill.

 The little pink pill getting the green light from the Food & Drug Administration. Flibanserin is the first prescription pill to boost libido in women.

 

BROOKE: Just so’s you know, Flibanserin is not female Viagra. Not even close. Viagra was released in 1998 to fix a male plumbing problem by boosting blood flow to a certain body part. It does this by blocking an enzyme. Contrast that with Flibanserin, developed by Sprout Pharmaceuticals, to tackle hypoactive sexual desire disorder (HSDD),  defined as a chronic and distressing lack of sexual desire, in women.  It seeks to restore libido by increase the availability of dopamine in the brain. Like antidepressants, and unlike Viagra, no one knows quite how it works. And unlike Viagra,  you take it every day. But the advocacy group pushing for Flibanserin embraces the Viagra analogy. That group, called “Even the Score,” produced Viagra parodies to strengthen that link...

 

WOMAN [without accent] I’m a beautiful woman, laying in a bed, talking about your erection. Erection. [Ding sound]

WOMAN [without accent] Now that they’re distracted, let’s do something to change this? Women deserve better. Let’s even the score

VO Men who take erectile dysfunction medication may find it entirely useless if their partner doesn’t have any desire.

 

BROOKE: It’s not a drug, it’s a movement! I mean consider the name Viagra - an unsubtle melding of Vigor and Niagara. Whereas Flibanserin’s brand name is Addyi, which Sprout told the website Bustle “represents the individuality of the first of her kind, and the definition of a woman's best self." Hm. too subtle, I think..

 

JIMMY FALLON:  So lets take a look at the pros and cons of Female Viagra. Pro: the drug is called Flibanserin. Con: It’s street name is She-alis.” 

BROOKE: Thanks, Jimmy! Now I get it. It evens the score.  Sally Greenberg.

 

GREENBERG: Even the Score came together after a group of both consumer health and women’s advocacy proponents went out to the Food and Drug Administration for a meeting to discuss with officials there why it had taken so and been so difficult for the FDA to approve a treatment for women’s sexual disfunction.

 

BROOKE: Sally Greenberg is executive director of the National Consumers League and a member of  Even the Score, which lists Sprout among its funders. She says she was pulled in by stories of suffering, like that of Amanda Parrish, here testifying at the FDA, which had twice rejected the drug.

PARRISH: often pretending to be asleep...as if a light switch had been turned on, so was I.

GREENBERG: Even the Score was formed not just to raise awareness about the need for treatments for women’s sexual dysfunction, but also to raise with the FDA and the medical community the issue of why in 1998 it seemed so easy to get a drug for male sexual dysfunction

BROOKE: Even the Score has suggested that there is sexism afoot.

GREENBERG: Unconscious gender bias at the FDA and perhaps in the medical community on this issue. And I’m one of those people who would argue that that’s true. Women who consider themselves feminists I understand are suspicious, and think that this is a creation of a drug company for a condition that doesn’t exist. And I just think that is so wrong, to say that has been manufactured and the women are made to feel bad about themselves. Women feel bad about themselves now.. It is women with a recognized condition that has been recognized for decades.

BROOKE: Even the Score started you said in 2013, and it was not started by Sprout?

GREENBERG: No. Really came out of our first meeting at the FDA.

BROOKE: But how did you get together to get to the FDA?

GREENBERG:  Well somebody did bring us together and we met with some clinicians and heard about the situation and then we said wait a second, what’s going on here

Brooke: And the person who brought you together wasn’t Sprout.

GREENBERG:   Was not Sprout.

Brooke: Ok.

GREENBERG:  Well, it was a consultant I think for Sprout.

CACCHIONI: I think the fact that that same company so committed to women’s health and empowerment apparently sold the drug for a billion dollars the day after it was approved I think that speaks volumes

 BROOKE: Thea Cacchioni (THEE-ah CATCH-ee-OH-nee) is an assistant professor in Women’s Studies at the University of Victoria.

CACCHIONI: They were willing to kind of cast the story in very inaccurate ways, stating that men had 26 drugs approved for their sexual problems, which is just a flat out lie.

BROOKE: Is it? There aren’t 26 drugs to work with erectile dysfunction?

CACCHIONI: If you go on the FDA website you can see there’s a list of exactly what drugs have been approved for men’s sexual dysfunction. there’s about 5 Viagra type drugs, and there’s another drug approved for a very specific disease called Peyronie's disease. Other than that, many of the drugs that they listed have not been approved.

[CLIP MONTAGE]

CNN: “So this drug would be the first of its kind out there. Compare that to the 26 sex drugs that men have to choose from…”

Larry Wilmore: “Currently there are 0 drugs on the market that treat sexual dysfunction in women. You know how many there are for men? 26.”

MSNBC: “There are actually 26 drugs on the market to help men with any kind of sexual problems that they may experience. ”

CACCHIONI: And you may hear another number which is 43% of women suffer from Female Sexual Dysfunction, still used in scores of research.

[CLIP MONTAGE]

Al Jazeera: “for women,43% suffer from sexual dysfunction”

Fox: “Studies show that 43% of women at some point are affected by sexual dysfunction, versus only 31% of men.”

ABC: “more women suffer from sexual dysfunction than men do! 43% to 31%.

CACCHIONI: That came from a health survey of sexuality in america, and there was a list of questions, do you ever lack desire, are you ever unable to orgasm, just some very basic questions. If women ticked yes to one of those questions, the people who analyzed the research chalked that up to that women have quote unquote a Female Sexual Dysfunction diagnosis, and it was also sponsored by Pfizer the makers of Viagra.

BROOKE: Buzzfeed reported that the marketing campaign went beyond creative statistics. Even the Score, having positioned Flibanserin as a feminist issue, enlisted powerful groups like the National Organization for Women, and persuaded 11 Congressmen and women to sign a letter to the FDA noting that the call for gender equality in the approval of sexual dysfunction treatments has grown louder.

Some suggest that when the FDA approved Flibanserin this month, it caved under the sexism charge.

WOOD: If there is sexism or discrimination because there is a lack of treatments, that starts way earlier.

BROOKE: Susan F. Wood is director of the Jacobs Institute of Women’s health at George Washington University, and former assistant Commissioner for Women’s Health at the FDA.

WOOD: We need more research on women's health, we need more understanding of women’s biology and understanding of sex differences. so its grounded in something very real but it was used to stimulate a political and PR reaction. and their target was the FDA, but  their target was wrong.

BROOKE: She would know. She quit the FDA because political pressure delayed the plan B morning-after pill from being sold over the counter for years. But she has real doubts about Flibanserin.   

WOOD: I feel very badly for the reviewers and for the professional staff inside FDA because I do feel they’ve been pressured. This approval is relatively speaking very narrow. only specific physicians have to go through training before they can prescribe it, certain pharmacies have to get certified in order to dispense it. they also have to provide  counseling about not drinking any alcohol at all during the weeks, months, years that you may be taking this product.... right now, this product should be limited to women who are premenopausal, who have no other physical, or relationship, or medical, or drugs that could be causing a lack of desire. They must have serious psychological distress so they should have tried lots of other approaches before being prescribed this pill. However the fact that it was just sold for a billion dollars makes me think that the company anticipates marketing it far beyond that very limited group.

BROOKE: you’re concerned about off-label use?

WOOD: I am. Generally speaking it can be prescribed for anyone and the FDA can require them to have some special training and to provide informed consent about the risks. But if it is touted - as we saw Viagra go from what was thought to be a niche market to being prescribed widely off label - then we may see this with women. That this will become in perception, a product to promote women’s sexual health and sexuality. And yet, it doesn’t work!!

BROOKE:That’s a matter of opinion. In the clinical trials, women were tracked to see if they saw improvement in three areas, one of which was an increase in satisfying sexual  events, or SSEs. Those could be anything sexual, including activity with a partner, or solo, or fantasy. Nor does it require a big finish. Before entering the trial, the test subjects reported 2.7 SSEs a month, women on the placebo experienced  3.7 such events, and women taking Flibanserin, 4.5. That’s .8 more events a month, over the placebo.

KINGSBERG: So we're talking about how many women respond to flibanserin. And that's 50 to 60%. In all three trials, there were statistically significant differences between flibanserin treated women and placebo --

BROOKE: In 60% of the women.

KINGSBERG: Yes.

BROOKE: Mhm.

KINGSBERG:  Excuse me, no no no, the flibanserin group was statistically better than placebo. Ok?

BROOKE: Dr. Sheryl Kingsberg is a clinical psychologist and associate professor at Case Western Reserve University School of Medicine. She also receives consulting fees from Sprout pharmaceuticals. Several times she cited a 45 to 60 percent response rate. So did Even the Score’s Sally Greenberg, a response rate a lot higher than the 8 to 13 percent rate cited by Sprout and the FDA. I found this confusing. Kingsberg explained that the higher response rate, is the difference between the pretrial response - to that of women in the trial, both on the placebo and Flibanserin.  I said discounting the placebo effect was deceptive.

KINGSBERG:  Well, I hear you, but to say that there is only an 8 to 13% um, efficacy, also is deceptive. What you show is an improvement above placebo. And in the real world, we would expect that women who are not in a clinical trial taking flibanserin --

BROOKE: Will also experience a placebo effect.

KINGSBERG:  No, no no, well, certainly they can show a placebo effect, but the overall effect, right -- minus any placebo for being in a trial for anybody -- is going to be greater than that 8 to 13% which is the placebo corrected efficacy. And you can look at it and say, well, that doesn't look like a big effect, but it really is quite significant when you're looking at a CNS drug.

BROOKE:Those are drugs that work on the central nervous system. Like many antidepressants.

KINGSBERG:  And if you looked at other clinical trials, for other CNS drugs and other categories, like um, overactive bladder or irritable bowel syndrome, you would see the same kinds of rates of efficacy above placebo. And they certainly are effective in the real world.

BROOKE: Sally Greenberg.

GREENBERG: We’re talking about sexual satisfying experience for the women who have HSDD, they will take one more sexually satisfying experience, two more sexually satisfying experiences, because they have nothing right now.   

BROOKE: Interestingly, the condition Flibanserin was developed to treat, HSDD, was dumped as a diagnosis by the American Psychiatric Association’s Manual of Mental Disorders two years ago and replaced with a diagnosis called female sexual interest/arousal disorder, or FSIAD. Before that, arousal problems were addressed in a separate diagnosis.  But then researchers found that some women don’t fantasize, and don’t desire, until they get aroused. They were inextricably intertwined. So why am I telling you this? Because female sexuality, apparently, is complicated. 

BROTTO: Every woman really needs a thorough assessment.

BROOKE: Lori Brotto is a psychologist who worked on changing the diagnosis in the update of  the Diagnostic manual of mental disorders, the DSM5.

BROTTO: By and large, most of the studies have pointed to psychosocial...interpersonal, individual factors. I’ll give you a few examples. Women with low desire have 3x the rate of depression compared to women with healthy levels of sexual desire. Relationship satisfaction - that variable has shown up over and over again. Stress, distraction, lack of sexual skills, poor communication, these are all variables that come up.

BROOKE: Now you’re quoted as saying, the impact of relationship duration is something that comes up constantly. .. you said, sometimes I wonder if HSDD isn’t so much about libido as it is about boredom

BROTTO: Yeah, for both women and for men, although there is more of a pronounced effect of relationship duration on sexual desire in women than there is in men. So that in my mind absolutely should not be labeled as a desire disorder. This is a normative decline in desire that happens with relationship duration.

BROOKE: But absent bad relationships, exhaustion, mental or physical illness, drug use, babies, stress or boredom,, distressing loss of libido happens, and Brotto says Flibanserin may help a few people. But like other neurotransmitter drugs, there are side effects, including drops in blood pressure that could cause you to faint. The alcohol issue is particularly worrisome, because women metabolize alcohol differently from men, in a way that could prolong and intensify the impact of flibanserin in the blood. Sprout consultant Sheryl Kingsberg said 60 percent of women in the Flibanserin trials did say they were social drinkers, and there was no  sign that alcohol was a problem,  but the FDA wanted data.

KINGSBERG: The FDA did say since we don't have accurate numbers, we would like you to do an alcohol challenge. So Sprout followed the same, um, extreme challenge that was used in a Cialis study. And so they had subjects drink the equivalent of a half to a full bottle of alcohol within ten minutes in the morning on an empty stomach. The problem with the extreme challenge was that women really weren't able to tolerate that level of alcohol consumption without essentially throwing up.

BROOKE: So, of the 25 test subjects, 23 were men, doing a challenge designed to gauge the impact of extreme alcohol consumption on users of Cialis. An erectile disfunction drug.

KINGSBERG: My hope is that that will be a trial that is forthcoming and forthcoming soon. Because based on the fact that 25 people in the study, a quarter of them showed significant dizziness, alcohol is contraindicated for use of flibanserin... that's going to be on the label

BROOKE: Kingsberg says the health risks posed by Flibanserin are no worse than those presented by some widely prescribed anti-depressants. And for those afflicted with with unexplainable and otherwise untreatable loss of desire, they may be worth it. At the very least, women deserve the same chance as men to choose. After all, Viagra’s no walk on the beach. It can cause dizziness, headache, back pain, runny nose, blurred vision, a rash, upset stomach,, the inability to see the difference between blue and green,, four hour erections, possibly  an increased risk of melanoma, tinnitus, nausea, muscle aches, …(fade under)

BRING UP...(you’ve come a long way baby).....