A "little pink pill" to solve women's sexual problems probably won't be hitting drugstore shelves anytime soon. But that doesn't mean discussion of the need for it, or lack thereof, is likely to end.
On June 18, an advisory panel for the Food and Drug Administration recommended against the approval of flibanserin, which had been touted as a female Viagra. The FDA can accept or reject the panel's advice but usually chooses to follow it. In many drug approval proceedings, that would be the end of the matter.
In this case, the highly publicized hearing was preceded by a campaign launched by flibanserin's manufacturer, Boehringer Ingelheim, to educate women about the connection between the brain and desire. The campaign, called "Sex. Brain. Body.," never mentioned flibanserin, but the drug is purported to treat low libido by acting on brain chemicals such as serotonin and dopamine.
Together, the hearing and campaign fueled a long-standing debate over how to define, diagnose and treat low sexual desire in women.
Some medical experts say that low libido, or female sexual dysfunction, is a condition that can and should be treated with medication. Others say that a woman's sexuality is far too complex and is affected by too many other aspects of her life to be reduced to treatment with a pill.
This disagreement has been ongoing despite — or, perhaps, because of — the fact that sexual dysfunction disorders were introduced in 1980 to the Diagnostic and Statistical Manual of Mental Disorders, which is used for diagnostic purposes by medical professionals.
Some people are trying to propose that no medication for female sexual dysfunction should be approved because it's a fabricated condition, said Laura Berman, a sex therapist and author of "The Book of Love."
Berman herself disagrees. "There are real medical factors. Sexual response and sexual factors are in part physiological; you can't ignore that."
Hypoactive sexual desire disorder, which flibanserin was proposed to treat, is one of seven sexual dysfunction disorders currently listed in the DSM that can affect women. It's defined by a near, or complete, lack of sexual fantasies and little to no desire for sex, and it requires that a woman experience distress over her sexual functioning. Among the other disorders are female sexual arousal disorder, defined by the inability to become and stay sufficiently vaginally lubricated; female orgasmic disorder; and pain during intercourse.
Researchers have attempted for years to find solid numbers reflecting how many women suffer from female sexual dysfunction disorders.
One of the most frequently cited studies analyzed data from a 1992 National Health and Social Life Survey. Published in the Journal of the American Medical Assn. in 1999, the study found that 43% of women surveyed, ages 18 to 59, experienced sexual dysfunction. Of that 43%, 22% cited low desire, 14% had problems with arousal and 7% experienced sexual pain. In this and other studies, women younger than 35 were found to experience more distress over their sexual functioning than their older counterparts.
The findings, while still used by experts, came under some scrutiny when the lead researcher later revealed ties to pharmaceutical company Pfizer.
In other studies looking at the prevalence of female sexual dysfunction, results have been notoriously divergent. Over the years, researchers have estimated that from less than 10% to more than 50% of women ages 20 to 65 and 18 to 49, respectively, have experienced notably or long-lasting low sexual desire, according to a paper published in the Archives of Sexual Behavior in 2009.
The inability to establish a more precise number of women affected comes as little surprise to some medical experts. They say there are inherent difficulties in diagnosing female sexual dysfunction.
To begin with, known causes of low sexual desire in women are nearly innumerable.
In older women, hormonal change from menopause may be the culprit. But in younger women there's rarely an underlying physiological factor at play, says Dr. Bernadith Russell, a fellow at the American Congress of Obstetrics and Gynecologistswww.acog.org/ and the chairman of that group's task force on female sexual dysfunction.
"There are some tests that I would do in premenopausal women," she said, including assessments of thyroid function and screening for diabetes or endocrine disorders, "but that's unlikely to be the cause."
The root of the problem is more likely one of myriad emotional and psychological factors that are known to adversely affect women's libidos, including stress, depression, relationship problems, body image, infertility or a history of sexual abuse.
Women's reactions to sex drive also vary, which throws a wrench in the DSM's criteria that a woman experience distress about her sexual functioning in order to be diagnosed with a disorder Some may feel distress over normal, well-documented fluctuations in sex drive, such as those that follow the birth of a child; and some experience distress over their sexual functioning regardless of their level of desire. Such reactions lead researchers to question how much of what's being called dysfunction is a result of cultural expectations.
Other women feel just fine about having a low libido. The same report that established disparate estimates of women affected by sexual problems also found that of all women surveyed, 7% to 26% reported being distressed by having a low sex drive; that's less, in most cases, than those who reported low desire alone. Factors affecting distress included women's age, age at menopause and overall emotional well-being.
Another barrier to diagnosis is that there is no agreement within the medical community about what typical sexual behavior is for humans, male or female.
"Our understanding of normal sexual function is just evolving," said Russell, "so to make a diagnosis of abnormal sexual functioning, we would have to have normal pinned down pretty well, and we don't right now."
There's also a great deal of deviation from one woman to another. One woman's inactive spell, in other words, is another woman's second honeymoon. "I may have a patient who goes, 'something is really off with me — usually I have sex four-five times a day, and lately I'm just not into it that way,'" Russell said.
The uncertainties surrounding female sexual dysfunction have led some experts to suggest that pharmaceutical companies are jumping to treat the disorder prematurely and are interested primarily in generating profit.
Leonore Tiefer, clinical psychologist at the New York University medical school, spoke against flibanserin at the FDA hearing. Female hypoactive sexual desire disorder "is all about not having satisfying sexual activity, but that sounds to me more like not having a satisfying marriage, not being able to travel, having too much anxiety, or ignorance," she said. "I don't think the medicalization of sex is helpful for people to have a good sex life."
Other experts in the field of psychology say that pointing the finger at problems in a woman's life is just as damaging.
"It's as irresponsible to say that it is only in her head or relationship as it is for people in the medical community to simplify sexual dysfunction to being just a medical condition," Berman said.
For the time being, women seeking help for a low libido are treated with talk therapy, whether from a sex therapist, couples counselor or individual therapist. They may also be prescribed off-label medication including estrogen or testosterone creams, or antidepressants, although premenopausal women with normal menstrual cycles are rarely, if ever, treated with hormones.
But if a pill becomes available and is approved by the FDA, its popularity could quickly trump any slower-going solutions.