Authors: Patricia Cohen
In 1998, when the Food and Drug Administration
for the first time approved a treatment for male impotence, Viagra, doctors developed hand cramps from responding to requests for prescriptions. The market for male libido lifters reached $2 billion in 2010. Drug companies reportedly spend $100 million each year on advertising treatments for male impotence or flagging desire, rebranded as erectile dysfunction (or preferably by its nonrevealing initials, ED).
After the phenomenal financial success of Viagra, the feverish hunt for a female counterpart was on. Within a year of the drug's approval, scientific and professional conferences sprang up in the United States and abroad about female sexual dysfunction (FSD), an abnormal absence of desire frequently mentioned in connection with middle-aged women, both pre-and postmenopausal.
The effort to find a pharmacological answer
to FSD was further energized by a 1999 article in the
Journal of the American Medical
Association
about a study which estimated that forty-three percent of women between the ages of 18 and 59 suffered from sexual dysfunction. Drug companies and women's groups seized on the results to protest that female sexual problems deserved as much attention as male ones.
This examination of the sex lives of 1,749 women and 1,410 men had serious flaws. Anyone who reported problems with sexual desire, arousal, orgasm, pain, pleasure, or minor anxiety about sexual performance over a period of two months was included in the sexual dysfunction category. Such troubles were often reported by women who were dissatisfied with their partners or single, had physical or mental health difficulties, or had experienced a recent social or economic setback. Any woman who might have mentioned a disappointing sex life because she had just lost a job, developed a painful backache, was contemplating a divorce, or suffering from depression was labeled as having a sexual disorder. Two of the study's authors had links to Pfizer, which was in the process of developing a drug for FSD.
A series of scientists challenged this research, arguing that female sexual dysfunction was essentially a newly concocted syndrome fabricated by the drug industry.
Writing in the
British Medical Journal
in 2003, Ray Moynihan called female sexual dysfunction “the freshest, clearest example we have” of a disease created by pharmaceutical companies. “A cohort of researchers with close ties to drug companies are working with colleagues in the pharmaceutical industry to develop and define a new category of human illness at meetings heavily sponsored by companies racing to develop new drugs.”
More recent surveys have estimated
that seven to fifteen percent of women between 20 and 60 are distressed about problems related to drive, arousal, and orgasm, significantly fewer than the forty-three percent trumpeted by the 1999 study. Even these figures may exaggerate the problem. All the studies that found more than one in ten women were affected were financed by drug companies. In truth, research on female sexuality is sparse and ambiguous. It is not at all clear how many of these problems are signs of a sexual disorder and how many are related to other physiological dysfunctions or social pressure. Nor do scientists know how many middle-aged women might be affected.
Viagra and its competitors essentially work on a mechanical problem. The drug increases blood flow to the penis to produce an erection. The effect of a treatment can be measured. That isn't the case with female sexuality, a combination of desire, arousal, and gratification that cannot be gauged with a ruler.
As a Harvard Medical School newsletter
put it: “Without an empirical standard by which to assess female sexual function, it would seem difficult, if not impossible, to come up with criteria for female sexual dysfunction.”
Judgments about what a disease or disorder is reflect social and historical currents as much as they do science. Moral pronouncements have always had a hand in demarcating the border between sickness and health. In 1898, James Foster Scott warned men over 50 that sexual overexertion was bad for their health. Until it was removed in 1987, homosexuality was classified as a disorder in the
Diagnostic and Statistical Manual of Mental Disorders,
or
DSM,
the handbook published by the American Psychiatric Association. Changing norms and the development of the gay rights movement put muscle behind empirical evidence to bring about the reclassification.
The level of female desire
that certain doctors, advocates, and television writers consider normal would have been labeled nymphomania in previous eras. In the eighteenth and nineteenth centuries, lascivious glances from a woman were considered a sign of sexual madness, possibly brought on by masturbating, spinal lesions, an enlarged clitoris, reading novels, or eating too much chocolate.
Female sexual dysfunction was
added to the manual in 1980 and is essentially defined as “persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity.” No clear diagnostic keys distinguish someone who has it from someone who doesn't, and the process of updating the manual for the fifth edition, scheduled to appear in 2012 or 2013, has sparked vigorous arguments over how to improve the diagnosis.
The distress that plagues many people about their sex lives may be as much of a cultural phenomenon as a physiological one. Media portrayals of consuming, aching desire in the middle years have become common. Leonore Tiefer, a clinical associate professor of psychiatry at New York University Langone Medical Center, criticizes what she sees as “the
mandatory participation in high frequency, high pleasure, high desire culture,” or the
pressure to have “sex
âwomb to tomb.”
Some plastic surgeons
have said that widespread images available on-screen, on the Internet, and in magazines have inflamed concerns about the aesthetics of female sexual organs. They have been visited by women who say they have become self-conscious about the appearance of their genital features. Though there are no verifiable statistics on the emergence of genital plastic surgery, some doctors have reported that women are coming in for “vaginal rejuvenation.” “I was very, very self-conscious about the way I looked,” one middle-aged patient explained. “Now I feel free. I just feel normal.” In 2010, the first global symposium on a “new subspecialty,” genital cosmetic surgery, was held in Orlando, Florida.
Lori Brotto, a psychologist who is overseeing
the
DSM
's revised entry on female sexual disorder, is wary that conceptions of normal desire often reflect a male perspective. Persuaded by research from Rosemary Basson, a clinical professor in the Departments of Psychiatry and Obstetrics & Gynecology and one of her collaborators at the Center for Sexual Medicine at the University of British Columbia, Brotto believes that a focus on urges may be misleading. For women, desire is triggered by arousal. A decision to have sex, to be responsive to a partner's touch, may be at the core of the female sexual response, rather than an inescapable impulse.
In 2010, researchers who
analyzed the latest MIDUS results reported evidence of a gender gap in middle age sex. At age 55, men can expect an average of 15 more years of an active sex life, while women can look forward to 10.6 years. One explanation the researchers offered was that many more men in their late 60s have regular partners than do women of the same age. Another is the increased use of drugs that stoke men's sexual capacity.
Tiefer believes the push for a “female Viagra
” follows men's artificially induced sexuality.
Pfizer initially undertook testing
to prove that Viagra could work for women as well as men, but admitted in 2004 that this was not the case because female sexual disorders were the result of “a broad range of medical and psychological conditions.” Procter & Gamble's attempt to get the FDA to approve a testosterone skin patch for some women was rejected that same year because of a possible increase in the risk
of breast cancer and cardiovascular disease. Other variations are in the works. The Illinois-based BioSante Pharmaceuticals has been developing a testosterone patch, while Acrux, an Australian company, has tested a testosterone-based spray for women.
The German pharmaceutical company
Boehringer Ingelheim announced in November 2009 that it had completed the pivotal Phase III clinical trials of the drug flibanserin, used to treat the most common form of FSD, hypoactive sexual desire disorder (HSDD). The company reported that North American women in the trial had an average of 4.5 “sexually satisfying events” a month, compared with 3.7 by women who took a placebo and 2.7 by those who did not take any pills. Interestingly, European women did not register any significant change, an indication of how “cultural fictions” play an important role in expectations about sex.
Flibanserin was meant to treat depression but was ineffective. That meant it was a drug in search of a disease. The process brings to mind Latisse, the eyelash lengthener released in 2009 by Allergan, the maker of Botox and Juvéderm. Initially developed to treat glaucoma, Latisse turned out to have a much more profitable side effect: longer lashes. Before it could be sold as a prescription drug, however, Allergan needed the Food and Drug Administration's stamp of approval. But the FDA found itself in a quandary: What disease or condition was this new drug purporting to treat?
None existed, so the FDA
created one: hypotrichosis of the eyelashes, or not having enough hair. (The company is currently investigating how to treat hypotrichosis of the scalpâalso known as baldness.)
Finding a disease to fit the cure is similar to what advertising copywriters did in the 1920s, when they invented hundreds of syndromes, like bromhidrosis (sweaty foot odor) and acidosis (sour stomach). It is what the cosmetics and dermatology industries are currently trying to do to wrinklesâto get consumers to see them as a form of dermatosis, a skin disease.
The American Society of Plastic and Reconstructive Surgeons
employed the strategy in 1983 when it used the term “micromastia” for small breasts. A memo sent by the society to the FDA declared that “a substantial and enlarging body of medical information and opinion”
believes “these deformities”âsmall breastsâ“are really a disease,” since they create “a total lack of well-being.” Plastic surgeons assured patients that “normal breasts” could be achieved through augmentation surgery.
As the 2010 date
approached for the Food and Drug Administration's ruling on flibanserin, Boehringer Ingelheim launched a publicity campaign that included a website, Twitter feeds, and a documentary about the supposedly widespread problem of HSDD, declaring that six out of ten premenopausal women suffer from itâa claim disputed by a number of independent researchers. As part of a medical education class sponsored by the German pharmaceutical, doctors and nurses were asked to diagnose a 42-year-old working mother who cares for three children and her sick mother, and has no desire for sex. The correct response, the company instructed, was to evaluate her for a sexual-desire disorder.
“This is really a classic case of disease branding,” said Dr. Adriane Fugh-Berman of Georgetown University's medical school, who frequently testifies on behalf of plaintiffs in lawsuits against pharmaceutical companies. “The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient.”
Michael Sand, director of clinical
research at Boehringer Ingelheim, conceded the company has no idea how flibanserin works. “We don't understand the pathways,” he said. “What we think is that in women with HSDD there is likely an imbalance of serotonin, and that flibanserin is balancing the imbalance in these neurotransmitters.” With flibanserin, the company has shifted the focus from hormones to psychology. Boehringer Ingelheim is guessing that brain chemistry is at the root of the problem.
A Kinsey Institute survey
found that general well-being was the most frequently cited contributor to female sexual satisfaction, followed by emotional reactions, attractiveness, physical responses to lovemaking, frequency of sexual activity with a partner, the partner's sensitivity, one's own state of health, and a partner's state of health. This is not to say that middle-aged women and others do not suffer from sexual problems, only that a pill may not be the cure-all. Mindfulness training and cognitive therapy have also had success in raising low sexual desire.
In June 2010, the FDA recommended
against approval of flibanserin. Its assessment was that the benefits did not outweigh the side effects,
which included dizziness, nausea, and fatigue, and that the company had not proved that the drug increased women's desire (though panel members urged Boehringer Ingelheim to keep trying).
Social, commercial, and political forces can have as much to do with decisions about treatments as they do with scientific advances and health concerns. From miraculous hormone therapies to drugs that instill sexual vigor, many of the pitches and promises of middle age medicine echo those of the previous century. What is different today is the existence of better and safer treatments, an established scientific methodology to test them, and the means to communicate the results. What has not changed is the will to believe.
Attempts to remodel middle age have exposed the tension between authenticity and social acceptance, between the democratizing and coercive aspects of the market, between self-help and social responsibility, and between biological determinism and environmental influence.
Distorted information from advertisers and the media promote unrealistic expectations, whether about pills that ignite sybaritic sexual pleasure or sprays that promise to instantly and imperceptibly cover bald spots. Skeptics are chastised for failing to do everything they can to help themselves before it is too late.