Now it’s the women’s turn

“They have Viagra,” says the woman in the advertisement. “Now we have Avlimil.” The ad for the herbal supplement, which promises “an enhanced libido” and a “more frequent and satisfying climax,” is among the first campaigns touting pharmacological remedies for a condition called “female sexual dysfunction.”

Others promise to follow, as researchers at companies such as Pfizer Inc. and Procter & Gamble Co. race to introduce comparable sexual remedies for female sexual dysfunction, or FSD, ranging from testosterone patches and creams to electric clitoral-suction devices.

The lure for health-care companies: a potentially bountiful market that some think could rival the more than $1.7 billion in annual sales for Pfizer’s blockbuster drug Viagra, the erectile dysfunction remedy that 20 million men have taken. Those companies refer to a widely cited 1999 report that suggested that as many as 43% of U.S. women may suffer from some form of sexual dysfunction, and they point out that women tend to use drugs more frequently than men.

Overall, the market for all sexual dysfunction products, male and female, is expected to climb sharply during the next several years. Front Line Strategic Consulting, a San Mateo, Calif., market research firm, forecasts that sales will grow 25% per year to more than $5.4 billion by 2007. Most of that total is expected to be for products for men, including drugs that will compete with Viagra and new therapies to treat premature ejaculation, but remedies targeting women will account for an increasing share over the years, the consulting firm predicts.

The firm advised in a market research report last year that “pharmaceutical companies need to constantly reinforce the idea that sexual dysfunction is normal and educate about new treatments” and “positively influence the image of sexual dysfunction.... This would be the case when FSD products are launched.”

Meantime, the increasing focus on producing a female equivalent of Viagra has ignited a controversy about whether the drug industry is trying to rev up sales by pushing pharmacological solutions for a women’s health issue that may have multiple causes -- and remedies. Some doctors critical of drug industry efforts charge that the companies are trying to capitalize on some women’s insecurities by convincing them, and their doctors, that the sexually related problems are serious enough to require medical intervention.

Some drug makers have been organizing seminars and funding research at several women’s sexual health centers that have been founded across the country, such as the UCLA Female Sexual Medicine Center. There, the Berman sisters, urologist Jennifer Berman and psychotherapist Laura Berman, have been leading the charge for more medical research in the field of female sexual disorders. One of their studies includes a Pfizer-sponsored clinical trial to determine if Viagra works for women in improving arousal and orgasm.

But they are finding that it isn’t nearly so clear-cut for women as for men. Though psychological issues, such as unemployment and depression, certainly can affect men when it comes to performance in the bedroom, problems more often are physiologically rooted.

Viagra works by improving blood flow to the penis by dilating the blood vessels there. When a man is sexually excited, the arteries in the penis relax and widen, allowing more blood to flow, then these arteries expand and harden. Veins that carry blood away from the penis get compressed. More blood flowing in and less flowing out make the penis larger, causing an erection.

But much is still not understood about the physiological elements of sexual arousal in women. Blood flow to the genitals does appear to play a role, researchers say, but loss of libido is more common in women, and Viagra does not appear to help with that in either men or women.

Most doctors agree that women have far more difficulty than men in putting aside emotional and relationship issues when it comes to sex.

Urologists like to show a drawing of two electrical boxes to describe sexual variations in the sexes: The one for men has a single switch, “on-off”; the box for women is a complicated tangle of knobs, meters and wires.

Accusing the drug industry of “medicalizing” female sexuality research, a group of doctors, researchers, sex therapists and nonprofit agencies have formed a coalition called FSD-Alert.org. An Internet site explains the group’s purpose as opposing the “infusion of industry funding into sex research and the incessant media publicity about ‘breakthrough treatments’ that put physical problems in the spotlight but isolate them from broader contexts.”

No one denies that sexual drive in women, just as in men, tends to wane with age. Menopause, with its attendant reduction in estrogen production, can hinder lubrication in the vaginal area. Hormonal imbalances, thyroid deficiencies, antidepressants and birth-control pills can affect it as well. Moreover, there’s been little research about how gynecological surgeries, for example, affect the nerves involved in sexual arousal and pleasure.

FSD is now generally being defined as problems with desire, arousal, orgasm or pain during intercourse.

But other factors are more often at issue, these critics say, such as the quality of a woman’s relationship with her partner, whether she feels loved, how busy or stressed she is with her job or children, whether there’s abuse in her past and whether she’s depressed or harbors any resentment toward her partner.

“There are much more worthy aspects of women’s sexuality that the drug industry isn’t interested in,” said Leonore Tiefer, a psychologist, sex therapist and associate professor at New York University’s medical school, who is a leader in the coalition.

“My irritation,” Tiefer said, “is the great sucking up of brain power, research and attention devoted to endless meetings about rabbit vaginal tissue.... They talk about arousal and orgasm in simply biological-reductionist ways.” The overwhelming factor in women’s sexual hang-ups, she contends, is poor body image. Most women think they’re too fat. The drug industry plays on that insecurity by channeling it into the rubric of a “dysfunction” that requires a pill to fix, she believes.

The group also worries that the emphasis is creating expectations about sexual performance that many women may have difficulty meeting. “Sex might or might not be important in somebody’s life,” Tiefer says, but our culture seems to dictate that great sex is something one cannot do without. From explicit scenes in movies and television shows such as “Sex and the City” to provocative ads in magazines and billboards, sex is omnipresent in society. What surprises Tiefer and many researchers is how few scientifically rigorous studies have been done recently about the sex lives of ordinary people. So people don’t know what’s normal, she says.

“People are always looking around for the norm and direction about what’s supposed to be the norm,” Tiefer says of the patients whom she counsels. “But there really is none.”

The federal government has funded few studies about sexual practices. One of the few major studies was done more than 10 years ago, when Edward Laumann, a University of Chicago sociology professor, and Raymond Rosen, a psychiatry professor at the University of Medicine and Dentistry of New Jersey, interviewed 3,500 Americans on their sexual habits and practices.

This often-cited study about sexual practices was not even originally designed to determine sexual dysfunction but to find out how people were putting themselves at risk of sexually transmitted diseases such as AIDS.

The data first appeared as a chapter in a book, but later the researchers extrapolated the data for a 1999 article in the influential Journal of the American Medical Assn. that concluded that 43% of women and 31% of men suffered from some sort of sexual dysfunction: The figures have been widely quoted since.

But Laumann says the study never suggested that “dysfunction” be viewed simply as “medical conditions” that can be treated with a pill or other medical therapy. For example, women in their 20s with children younger than 6 are two to three times less interested in sex than those without children. “It doesn’t take a rocket scientist to say they’re exhausted,” Laumann said in a telephone interview. Here, in fact, the lack of desire for sex could be explained, possibly, as a biological response that helps protect the mother from having additional children that would compound her problems, he said.

Moreover, he said, “our data are clear that relationship quality is important. When the relationship is poor, much more dysfunction is reported.” He also notes that women who have had a substantial decline in income in the past three years were more sexually dysfunctional than those with stable incomes, as was true with men.

Laumann, now a consultant for Pfizer, has since conducted surveys on sexual practices internationally and has found similar results.

Dr. Irwin Goldstein, a urologist at Boston University’s Institute for Sexual Medicine, contends that understanding the physiology behind sexual arousal and response in women is vital. “It’s amazing, in 2003, when we’re splicing genes, we still don’t understand much of what’s happening” in women’s genitals, he says. Using rats and rabbits, the institute is testing the effects of androgen and estrogen on vaginal, clitoral and labial tissue. The institute has developed a tiny probe to test blood flow to the animal genitalia. When a woman is sexually aroused, blood flow increases to the clitoris and the vagina relaxes, widens and lengthens, while droplets lubricate the cervix and the labia engorge, he says.

Dr. Mary Dolan, chairwoman of the gynecology and obstetrics department at Stanford University, agrees that medical intervention “doesn’t cure everything, but neither does therapy.” After menopause, women complain of vaginal dryness, which occurs as estrogen levels decline. “Women will say, ‘I love my husband, but things have changed,’ ” she said at a recent seminar. “They will say, ‘I can’t get aroused.’ ”

Dolan says getting enough sleep and exercise can help, but she also believes there may be a role for nutritional supplements. She conducted a study of 108 patients for a nutritional supplement called ArginMax, which contains the herbal product ginkgo biloba. In the study, 61% of the women who took the supplement reported an increase in the frequency of sex, compared with 32% of women who took a placebo, or ineffective dummy pill.

Indeed, in the Bermans’ study of 202 postmenopausal women, the placebo effect for Viagra in women was also quite high -- about 43% of a control group of women taking a dummy pill reported improvement in genital sensations, compared with 57% of those taking Viagra.

Perhaps, suggests Tiefer, this is because in the study the women “all get attention, encouragement and permission -- the very things we know are needed in improving sexual life. There’s nothing quite like an authority wearing a white coat saying, ‘Did you do it? How many times?’ It’s what your mother never said to you.”

Other drug makers are evaluating hormone treatments, in the form of pills, gels and creams, that would stimulate sexual interest. Procter & Gamble, for example, is testing a testosterone patch for women, because testosterone has also been reported to be helpful in stimulating desire; though men have more of it, women also produce testosterone in their adrenal glands and their ovaries, and it has been linked to greater sexual desire.

As of yet, the only prescription product that has been approved by the Food and Drug Administration for women’s sexual dysfunction is the EROS Clitoral Therapy Device, a small suction device that is placed over the clitoris to promote blood flow to stimulate arousal.

Avlimil, the supplement being widely advertised, is made of a variety of natural ingredients, including leaves of sage and red raspberry, as well as the roots of ginger, licorice, black cohash and kudzu. (Makers of dietary supplements are not required by the U.S. government to test their products in clinical trials to demonstrate safety or effectiveness.) Warner Health Care says that it has received 200,000 orders for the $35-a-month supplement.

Dr. Michael Sweeney, the urology group leader at Pfizer, says the company is conducting more extensive trials with Viagra on women and is encouraged by the initial results. No one would have thought there’d be a drug for erectile dysfunction in men either, he says. “Had somebody suggested they could produce a tablet taken by mouth, people would have laughed us out of the place. People would have been incredulous.” But that’s just what happened when they saw that a drug to dilate blood vessels in the heart didn’t do much there but did a great deal in the genital area.

Much the way Pfizer helped replace the term “impotence” with “erecticle dysfunction” in advertisements featuring former U.S. Sen. Bob Dole and other celebrities, the company hopes to take FSD out of the closet, critics notwithstanding.

Still, Viagra is no panacea. Pfizer claims it works for 80% of sexually stimulated men who try it. (It is less effective in those with health conditions such as diabetes.) Nevertheless, at least 40% of Viagra prescriptions are not renewed, suggesting that drugs can’t solve many problems. “You have to remember the context and whether resumption of sexual activities is what works for a relationship at that time,” Sweeney says. “If the couple has not had sex for 10 years, they establish a new equilibrium and, when intercourse starts, that equilibrium may not be the way they want to go.”