Friday, June 5, 2015

Flibanserin: Female Libido--Even the Score Fights to Win

J.S. Sergeant Egyptian Girl 

Here's a story which made it above the fold in today's New York Times: "FDA Panel Backs 'Viagra for Women.'"

"The move was immediately hailed by some women's organizations as a step toward sexual equality by, in effect, giving women their counterpart to Viagra, the widely prescribed drug for male erectile dysfunction."

"The controversial campaign by some women's groups to win federal approval was waged under the banner Even the Score, which accused the FDA of gender bias because it had approved Viagra and other drugs to help men have sex while leaving leaving women without options."

"Susan Scanlan, chairwoman of the Even the Score coalition, hailed the vote, saying in a statement, 'Today we write a new chapter in the fight for equity in sexual health.'"

Oh, we wrote a new chapter, but I'm not sure it was the chapter Ms. Scanlan describes.

Let us examine the many ways in which wrong has ascended here.

1. The FDA is supposed to function to protect the public health by approving drugs which have met two criteria: 1. They are safe.  2. They are effective. 
The study of 5,000 women in which half got a placebo and half got flibanserin and were then interviewed about how many satisfying sexual encounters they had had during the month was unconvincing on many levels. It is not like you can actually do a blood test and generate a number for the effect of a drug on libido. Many women will report their sexual appetite increases with a martini or two, and that can be convincing testimony, but with drugs we like to measure something beyond recall and testimony. The difference between the two groups was barely one additional night of good sex and there could have been many reasons for that. The placebo group increased their sexual encounters almost as much as the treatment group and that ought to tell us something.

2. The fact the FDA has not approved a drug to improve libido in women who have low libido does not mean the FDA doesn't care about low libido in women; it means nobody in the drug industry, at the FDA, in medicine, in endocrinology or gynecology, in the whole wide world really understands female libido. 
Males are pretty simple: give them enough testosterone and they are looking for action. 
Give women testosterone, or estrogen or any hormone you care to mention and nothing happens. 
We simply do not understand the basic physiology of female libido or the pathophysiology of it's absence.  
So, if women who lack libido were left without options, it was not because of indifference or wrong doing by the FDA.  It was because science has not provided options. The failing, you see, is not a failing of the FDA. Got that? Is that really so difficult?

Flibanserin may act on neurotransmitters, may accentuate the dopamine and dampen the serotonin but nobody really understands if or how these transmitters work in female sexual libido.  
A similar outcry arose in the early days of HIV, when activists cried out the reason there was no cure was nobody cared about gay men dying. That was untrue. The reason there was no cure was the doctors didn't know what to do. Spending more money did not solve the problem; science eventually did. Sometimes money cannot buy insight.  The response of non scientists in Congress to a problem like AIDS or almost anything scientific they don't understand is to vote for more spending, but that's because they are ignorant Congressmen.

3. Flibanserin, even if it were effective at increasing female libido would not be a female Viagra. Viagra and its fellow travelers do not increase male libido. Viagra improves erections. To have good erections you need working blood vessels, working nerves and adequate levels of testosterone. Viagra takes care of the blood flow.  Testosterone is what usually drives libido in males and there is no such agent for driving libido in women.

4. Libido is one thing, but having enjoyable sex is another. Libido is the first step down the road. We understand even less about what drives female libido in chemical terms than we understand about what allows women to achieve orgasm. 

5. Voting for approval of a drug aimed at a problem which vexes women is not the same thing as actually solving that problem, if the drug is ineffective, which, may be flibanserin's problem.  
One of the doctors who voted for approval explained: "The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product ...seems to be the right step at this point." 
Which is to say, "We were taking a lot of heat to approve something, anything, so we caved to political pressure, even though the public health service and the FDA is not supposed to cave to political pressure. We are supposed to do the right thing."

6. People who earn their salaries by winning fights in the halls of Congress or the FDA were able to make this decision not a consideration of the science but a test of intentions and "a fight for equity in sexual health."

The fact is, I wish we had an effective pill for low libido in females. 
I wish we had an effective pill for baldness and for obesity and for breast cancer and for lung cancer and for melanoma and for diabetes and for a whole lot of problems for which we do not have cures or even effective management. 

But you cannot vote a cure for medical problems. You cannot win a fight against inequity in sexual health if there is no science to help you.  Parsing uplifting phrases does not help in medicine. 

We have allowed moneylenders in the temple when it comes to allowing Even the Score to  bully the members of an FDA panel into voting through a medication not because it works, but because it satisfies the needs of the board of directors of Even the Score.  Activists simply do not deserve a seat at the table when it comes to medicine. 

Which is not to say we should not sympathize with their cause. When Act Up picketed Building 32 at the National Institutes of Health, the head of the Institute for Allergy and Infectious Disease was Tony Fauci. (He still is head of that institute.) He walked by the pickets, took the elevator up to his office and asked his secretary why anyone would picket a building at the NIH. She told him, "They're picketing you, Dr. Fauci."  He sent for the pickets and brought the whole lot of them into a conference room and asked them what they wanted and what they expected him to do. 
They told him the reason there was no cure for AIDS was nobody cared about patients who got AIDS because it was thought of as a gay disease. 
Fauci replied he had a lot of very good scientists who were working hard on an antiviral agent both on campus at the NIH and spread out across university health centers across the country. He described the units he had set up at the Clinical Center where patients with AIDS were dying in beds attended by nurses and doctors who were risking their lives just starting IV's and doing routine care on those patients. "If you think nobody cares, you've never talked to any of the men or women who come to work every day at the Clinical Center." 
The activists listened and were convinced. They came as angry men and women with a cause; they left Fauci's office understanding anger and passion are not the answers in medicine. They had been educated in the reality of disease and the realities of medical care.

Someone should do the same for Even the Score. 


  1. Mad Dog,
    I agree, this is much more the story of a brilliant marketing ploy than it is the tale of a medical breakthrough. Sprout Pharmaceuticals, the new owners of Flibanserin knew a good thing when they saw it. Here was an opportunity to turn a business venture, bringing a drug to market, into a cause and they grabbed it. Not every drug provides that opportunity-it's hard to imagine a new drug for say,cracked heels, generating that kind of coverage and ability to morph into a political cause. One thing that remains a question is just how widespread a political cause it actually was, or were the voices in support of it just a few, carefully orchestrated by the drug company. Perhaps the FDA advisory panel caved because of the outcry they feared, rather than what was actually taking place.There wasn't much difference in the data the third time, than there was the previous two times the drug came up for approval and was denied, except the third time it had supposedly become a women's rights issue.. Even though the drug seemed to have pretty lack luster results and the manufacturer has agreed not to market it on TV and radio for 18 months, it's a good bet the drug company will get right on getting the word out in other ways... Most women will probably not realize how little the difference in results are between Flibanserin and a placebo. They may accept the marketing claims of the manufacturer and line up to buy a drug of very limited efficacy...So I'm struggling to see where women's rights have been advanced in this instance..seems there should be a cry of foul by more mainstream and well known women's groups..

  2. Ms. Maud,

    Your analysis is, as always, trenchant.
    This drug is, as far as I can see, more like Wellbutrin than Viagra.
    Some antidepressants have been thought to heighten libido, but likely these agents are the members of the SSRI class which simply do not depress libido and so they are, by comparison, more sex friendly.

    All this is supposed to be a balancing act between inhibitory serotinin and excitatory dopamine, but the understanding is so rudimentary as to be likely simply inadequate.

    The striking thing is the anger expressed about women who are unhappy because they do not want sex. Where else do we have a complaint about disinterest? I'm not saying this is not a problem, but I wonder whether the disinterest is a symptom rather than a disease, at least for some women.

    Until we understand the physiology better, I'm still stuck with Gloria Steinem's famous remark: "I cannot breed in captivity" which expressed succinctly what I've heard so many women say: When we were just fooling around, sex was such fun. But as soon as we started signing contracts, leases, telling our family and friends and we became an institution, the fun evaporated.

    Surely, this is not the case for every woman, but I suspect it operates for at least some.

    Treating cracked heels is, as you suggest, way simpler, that is as long as the patient is amenable and that finding does not evoke deeper connections.

    Mad Dog

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