The People's Perspective on Medicine

Sex Pill for Women Cracks Medical Taboo

Flibanserin has been highly controversial as a sex pill for women. Even women's groups are divided on its benefits and risks. Experts recommended approval.

The topic of women’s sexuality has been taboo for centuries. Both men and women are often uncomfortable discussing female libido.

Men’s sexuality, on the other hand, has received a lot of attention. Prime time television commercials for Viagra, Cialis or Levitra have made ED (erectile dysfunction) a household acronym. In addition, ads for testosterone supplementation for men emphasize the benefits for libido as well as strength and energy.

Off Label Prescribing of Testosterone

For years, however, women who complained of low libido have had no recourse. Some physicians prescribe low doses of the male hormone testosterone to improve sex drive, but there are risks such as facial hair, oily skin, acne and voice changes. This was an “off-label” use that the FDA frowned upon.

Female Libido: A Controversial Topic

More recently there has been growing interest in newer drugs that might actually affect brain chemicals to restore libido. The idea of a sex pill for women has been highly controversial, though. Some advocates maintain that medicalizing women’s sexuality is nothing more than a ploy by the pharmaceutical industry. They insist that low libido can be better addressed with talking therapy or couples counseling.

Others insist that there is a strong biological component to libido. They report that a total lack of sex drive has a devastating effect on their relationships and their lives.

An article in the New York Times (June 13, 2015) titled “Aid to Women, or Bottom Line? Advocates Split on Libido Pill” reveals the divide in women’s organizations about the new sex pill for women. For example, the National Women’s Health Network and Our Bodies Ourselves did not support the campaign to “Even The Score.” This was the public relations effort designed to sway experts at the FDA to recommend approval for the new drug called flibanserin. The National Organization of Women had a representative speak in favor of the drug  and other women’s groups also supported the initiative.

A Personal Story

One reader shared her story:

“I’m a female, 26 years old, married for eight years with one child. Since I had my child, my sex drive has vanished. Over the last four years I have lost all desire and sexual responsiveness. I am too young to be deprived of this part of life. This problem is stressing my husband out and putting a real strain on my marriage.”

We have received dozens of similar messages to this website over the years and most are powerful and poignant.

The New Sex Pill for Women

Over the past several years, a sex pill for women that would help improve libido has been developed. Flibanserin (Addyi) was submitted for FDA approval twice before 2015. Both times the agency rejected it.

Recently, however, a panel of experts met to advise the FDA on whether to approve flibanserin. After hearing testimony on the drug’s effectiveness (which seems to be modest but statistically significant), the advisory committee voted to recommend approval.

The green light came with substantial reservations, however. The health professionals were underwhelmed by the drug’s ability to stimulate sex drive.

They were also quite concerned about possible side effects. Flibanserin can cause dizziness, drowsiness, nausea, low blood pressure and fainting (syncope).

The panel was especially worried about a potential interaction with alcohol. Because the drug has to be taken for long periods of time, some experts worried that cautioning women not to drink alcoholic beverages would be unrealistic.

Despite these qualms, the committee voted 18 to 6 that the FDA should approve flibanserin for hypoactive sexual desire disorder (HSDD). It is expected that the FDA will give the drug the go-ahead sometime later this year. There will likely be restrictions and special precautions for its use.

You can read our blog about the hearing here.

Perhaps the most encouraging aspect about the flibanserin hearing is that it will open the door for more research into human sexuality. Better communication may also result, so that women’s libido is no longer such a taboo topic.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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What is wrong with using something natural? Something that does not involve drugs? It is well known that a woman can be sexually aroused with vibration in the vicinity of the clitoris. Why is this not acknowledged and encouraged?

I wish they would focus on research as to why Women lose their sex Drives after having a child. I sure lost mine and now I’m 57 and still nothing!!

The comment by Pharmabuse sounds compelling to me. Frankly, the very fact that pharma is selling something makes it suspect in my eyes. In other words, that industry has zero credibility with me.

Interesting article, but I do not see why you should have to choose a photo of a large-breasted woman showing lots of cleavage as the photo to illustrate your article. I am sure you could come up with a better photo than that…. or even a photo of a bottle of the new drug… or is it just easier to find photos on the internet of a large-breasted woman?

The so-called sex pill for women does not crack any medical taboos, but rather runs a very familiar route in Big Pharma’s playbook – deceptive manipulation of clinical trial data. What was different this time, from the other two when the FDA panel rejected Flibanserin, is that Sprout Pharmaceuticals ran a very effective “Even the Score” campaign making gender equality, not medical science, the issue. Big Pharma, with the help of Madison Avenue, successfully diverted our attention away from what really matters when approving or denying any drug – whether the drug is effective and whether it is safe.

Even panelists who voted to approve the drug this time under public pressure did so reluctantly, expressing concerns about the drug’s marginal benefits as demonstrated by the clinical trial data.

In one study, there were 135 clinical trial dropouts on Flibanserin versus only 101 dropouts on placebo. Likewise, in another clinical trial, there were 95 dropouts on 50mg Flibanserin, 114 dropouts on 100mg Flibanserin, versus 75 only dropouts on placebo.

The side effects of the drug caused more subjects taking the drug to drop out of the trial(s) when compared to placebo. In one study, 53 withdrew due to adverse effects of Flibanserin versus only 20 on placebo.

In typical Pharma fashion, those who dropped out of the clinical trials due to adverse effects did not get tallied in the final results, having the double effect of exaggerating the benefits of the drug while understating its risks. It would be akin to our public schools boasting that students’ test averages have improved, because more students flunked out of school, raising the average of the remaining students.

Even with the skewed clinical trial data, Flibanserin only led to women on the drug having sex one more time per month over women on placebo. With such meager, albeit exaggerated benefits, to compare Flibanserin with Viagra is to deceive the public. Viagra actually works.

We are witnessing Pharma’s new wave of demographic-targeted marketing. It works, because co-opting existing, often worthy social agendas produces an instant “grassroots” movement. The clever marketing strategy works just as well in the bedroom as it does in the classroom. Racial equality, for example, has been successfully co-opted by Big Pharma to unnecessarily drug an alarmingly increasing percentage of minority children for “mental disorders” like ADHD, under the banner that they have previously been denied equal access to mental health care.

If gender equality is the crux of the issue regarding Flibanserin, then the disproportionate reaction to a drug with such doubtful benefits shows us that women can be deceived by Big Pharma just as easily as men.

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