Female Libido Pill Leaves Ethicist Cold

Could popping a daily pill be an answer to decreased sexual desire in women? A German pharmaceutical giant’s hopes of cashing in, to the tune of an estimated $2 billion annually, on a “little pink pill” were rebuffed recently by the federal Food and Drug Administration, which is not convinced the drug has proven benefits that outweigh its side effects. One thing the proposed treatment did arouse is sprawling debate about whether anyone can define what constitutes a normal sex drive, how many subjective, circumstantial, and still mysterious factors contribute to waning libido in women, and whether repurposing a brain-targeting, failed antidepressant as the newest lifestyle drug is the latest example of what some in the medical field call disease mongering.

Boehringer Ingelheim, the company hoping to launch the purported libido booster flibanserin, is already in the throes of a promotional campaign armed with a Web site, a Twitter feed, a Discovery Channel documentary, and a publicity tour by soap opera actress and former Playboy model Lisa Rinna, who offers a pep talk, woman to woman: “Many women are consumed by balancing their personal relationships, family lives, and demanding careers. In trying to do it all, we sometimes put our own needs on the back burner.”

Confused? There are many reasons to be, and one of them is the fact that in Boehringer’s trials, 15 percent of the subjects dropped out because of nausea and dizziness and/or fatigue (several fainted), and in the rest the pill barely edged out the placebo. To shed some light on the company’s claims, the escalating trend in disease branding, and the pill’s misnomer as “the female Viagra,” BU Today spoke with Leonard Glantz (CAS’70, LAW’73), a professor of health law, bioethics, and human rights at the School of Public Health and of sociomedical sciences and community medicine at the School of Medicine, who has written numerous books on health issues.

BU Today: Time magazine and others have dubbed flibanserin the “female Viagra.” Does this make sense?
Glantz: There’s actually no connection at all between Viagra and this medication. With Viagra one isn’t dealing with issues of desire, but with issues of performance, and the assumption is that with Viagra there is desire. Viagra really has to do with the vascular system — with blood going to places where it hasn’t previously gone. And unlike Viagra and other erectile dysfunction medicines, this pill must be taken every day, just like an antidepressant.

Can sexual desire be measured scientifically?
You can’t measure desire. I could have you fill out a questionnaire every day that asks, do you want ice cream or not. All I’m measuring is your desire, not how much ice cream you actually eat, or what kind of ice cream it is. If the general public wants ice cream every day, and you want it just twice a week, you’re suffering from hypoactive ice cream disorder. And I have a pill for you, so you can want ice cream more. I, for example, have no golf desire. I have hypoactive golf disorder.

Isn’t it obvious that certain life circumstances can seriously stifle sexual desire?
That’s another question. How do we determine which women have an adequate or inadequate desire as a result of their experiences with partners, life stresses, children, jobs, and all that, as opposed to a problem with their brain chemistry? And this drug does affect brain chemistry. It was created as an antidepressant, but didn’t work that well, so the company decided to try it for something else.

After reviewing Boehringer’s data, do you think the drug is effective?
The drug doesn’t work. Depending on what was measured, there could be a slightly positive statistically significant improvement for subjects taking the drug versus placebo, but it’s very tiny. There’s a difference between statistical significance and clinical significance. And the company’s results indicate that if one asked women about a change in sexual desire, the drug didn’t make a difference at all. But when asked about sexual satisfaction in their experiences while medicated, there was slight improvement. One of the notable things about the study is that desire went up for women on placebo too; it went up quite a bit.

In light of this, the side effects seem prohibitive. How can these be justified?
With this drug and its questionable effectiveness, the side effects would cancel out any benefits. There’s no such thing as a safe drug. Safety is judged in relation to the benefits. Chemotherapy drugs are poisons; the only reason we use them is because of the potential efficacy in fighting cancer. In this case, of the 5,000 women in the trial, 750 found it intolerable and the rest were nauseated, dizzy, and some fainted. It’s a real drug, and it has to be taken every day. The question of how much benefit you’d need to have to outweigh this would be hard to answer. Even for people convinced that there is a hypoactive sexual desire disorder in women as a result of their brain chemistry, and women with the condition would want a drug, this just isn’t the one. Also, the trial was just 24 weeks, so the long-term effects aren’t known.

Can low sexual desire accurately be called a disease?
For one thing, sexual desire — which is not the same as sexual arousal or the ability to achieve orgasm — is measured only by self-reporting. Desire is so subjective, and depends on so many things. And it is mysterious — the great mystery. If you look at DSM-IV (the latest version of the Diagnostic and Statistical Manual of Mental Disorders), there are sexual disorders such as anorgasmic men and women and painful intercourse, but hypoactive sexual desire disorder is not gender-specific, and the manual’s purpose is just descriptive. The reality is that this company, like all companies, is in the business of selling a product, and one way to do that is to increase demand. Those are just general marketing rules, so there’s no question that the company has an interest in convincing women that they have a disorder and they need this pill. Some people call it disease mongering. It’s problematic, and it doesn’t make the country feel any better.

Since doctors do the prescribing, shouldn’t they speak out more about the questionable branding of new so-called diseases?
Doctors are subject to marketing and patient pressures. There’s the thought that doctors should be the learned intermediaries, which they are sometimes, but not always. To think that doctors are robots not amenable to marketing is just wrong.

Is there a distinct condition known as hyperactive sexual desire, or nymphomania — the other side of the coin?
I just asked someone from the Boston Women’s Health Collective about that. Clinical talk of nymphomania went away, but there is a diagnosis of compulsive sexual behavior, with a checklist of symptoms — impulses are beyond one’s control, can’t maintain emotional closeness, having frequent sex with prostitutes. Remember the Kinsey Reports? The surprising thing they found was that women actually wanted to have sex, women masturbated — oh my God, those were huge findings. So the desire issue does have to do with attitudes. It used to be that there were loose women, but no loose men, just playboys, cads, and bounders. The notion of excess sexual desire was only attributed to women, and back then pedophilia and homosexuality were in the same category. This demonstrates the lack of science in these classifications and reflects not just the mores of the time, but also the mores of the psychological and medical profession. There’s a reason the DSM is five times larger now than when it started. It’s meant to be descriptive, and it’s the result of doctors voting on entries.

Don’t the attitudes of the doctor figure to some extent in a diagnosis like hypoactive sexual desire disorder?
Yes. One of the interesting things about this disorder is the diagnostic criteria — one is “deficiency of sexual fantasies.” The determination is made by the doctor, who takes into account the context. So if you tell the doctor your husband smells and comes home drunk and you don’t want him to touch you, there’s no disorder. But if your husband comes home with flowers and greets you lovingly and smells good and you have no desire, you have this disorder. But these women have identical symptoms. Yet in real diseases like diabetes, diabetics have the disease whether they’re distressed about it or not.

Do you think this pill will eventually receive FDA approval?
I think chances of this pill getting approved are zero. When you read the FDA report, things are problematic: when the company couldn’t show that sexual desire increased in a significant way, they tried to get the FDA to look at something else. The drug doesn’t work, and it has side effects.

Susan Seligson can be reached at sueselig@bu.edu.