By David Segal
Washington Post Staff Writer
Wednesday, March 12, 2008
Viagra turns 10 this month, and didn't time just fly? It seems like only yesterday we started guffawing at the Symbolism for Dummies ads on TV for the little blue pill and its "erectile dysfunction" rivals -- footballs tossed through tires, faucets erupting. The spots ended with a list of potential side effects that sounded like a satire of potential side effects. "More than four hours ?" we winced. "Ouch."
However discomfiting the commercials, the Food and Drug Administration's approval of Viagra -- on March 27, 1998 -- is a landmark day in the history of sex. It seemed at the time like a biomedical revolution was upon us all, and about five minutes after word of the magical med went global, the question first was asked: Where is the women's version of Viagra?
The short answer: They're still working on it. A bunch of companies have tried and failed to create "pink Viagra," as it's often called. Other companies have drugs in late stages of clinical testing, including a gel that recently began a make-or-break nationwide study with several thousand women. Give us five years, maybe less, say the most optimistic researchers and doctors. Though it's unclear exactly how many women would ask for a prescription, no one doubts that the first company that gets to market a remedy for female sexual dysfunction, as it's formally known, will earn a fortune.
But as this race reaches what could be its final lap, not all of the spectators are cheering. Some, in fact, are booing as loudly as they can.
A modest-size but fervent group of psychologists, academics and public health advocates contend that FSD isn't an authentic medical condition, or at least not the sort of problem that should be treated with drugs. These aren't the obtuse male physicians who for decades have been telling women distressed by their lack of libido that "it's all in your head." The anti-FSD crowd is mostly women, many of them self-described feminists. The most prominent is Leonore Tiefer, a psychotherapist and clinical associate professor at New York University, who has long decried what she calls "the medicalization of women's sexuality."
"Drug companies want to say to women, 'You don't need to know anything; you can have the satisfying sex life that you seek -- people dancing on TV, the whole bit -- without knowing anything. Just ask your doctor,' " she says. "I resent that, because there are specific harms that come from being ignorant and dependent in the world we live in. There may be lots of people who aren't interested in sex, but is there a medical reason for that, and do we diagnose that?"
Tiefer's critique centers, in part, on the way that pink Viagra is sure to be marketed -- with ads day and night, suggesting that women who aren't feeling frisky have a medical problem. She and her allies -- organized as the New View Campaign -- are also galled that so much money and media attention are heaped on the lust drug, even before it exists, when for many women the solution to their libido problems isn't that exotic. Maybe they have a partner who hasn't a clue about technique.Maybe they're stressed out. Maybe they can't possibly get in the mood because they're so busy raising children. Therapy, counseling, even free day care, says the New View Campaign, might do more for women's sex lives than any drug company ever could.
"People walk out of their doctors' offices with a prescription in hand 85 percent of the time," says Meika Loe, the author of "The Rise of Viagra" and a New View endorser. "But health insurers won't pay if you want to talk to a counselor or if you need advice about how to communicate your sexual desires. We've got a health-care system that is almost entirely focused on medical solutions."
On the other side of the FSD divide, allied with the pharmaceutical companies, is a group of physicians who are prescribing off-label treatments for women vexed by their sex lives. (Off-label means the drug hasn't been approved by the FDA for that specific treatment.) The highest-profile of the bunch is Irwin Goldstein, the director of sexual medicine at San Diego's Alvarado Hospital. He and Tiefer have debated the topic of FSD for a decade, but as far as he's concerned, there's really nothing to discuss. He's been using hormones to treat women, and he'll happily put you in touch with patients who will rhapsodize about the results.
Women like Virginia, a 60-year-old native of Britain and an artist who, for privacy reasons, asked that her last name be omitted. She'd spent years asking doctors for medical help to boost her sex drive, which had once been voracious. All of them, she says, "rolled their eyes and harrumphed and tried to change the subject."
"But when I was younger, a really strong libido was just part of who I was," she goes on. "Losing that was like losing a good friend."
Three years ago, she heard Goldstein interviewed on National Public Radio. Within weeks she flew to Boston, the site of his practice at the time, and she soon was taking several hormones. There was tinkering with the combination and the dosage, but a few weeks later she suddenly felt "perky" -- more confident about herself as a sexual being and more attractive. She also started having better sex.
"I could get to seventh heaven years ago, and now I can get to fifth," she says. "That's far better than purgatory."The Flops
On one point everyone agrees: The search for pink Viagra is proving trickier than anticipated. So far it's been one flameout after another.
There was PT-141, by Palatin Technologies of New Jersey, a drug inhaled via nasal spray and found, in preliminary tests, to produce friskiness in both men and women, leading to buzz in 2005 that people would soon be able to snort themselves into the mood. "The first real, honest-to-God, horny-making, body-shaking, equal-opportunity aphrodisiac," panted New York magazine that year.
Nuh-uh. In August, the FDA stopped clinical testing, citing concerns about a side effect high blood pressure.
There was Intrinsa, a patch made by Procter & Gamble that transmitted testosterone into the bloodstream through the skin. (Testosterone, associated with sex drive, is produced naturally in women, though in far lower quantities than in men.) Also dinged by the FDA.
And of course, long before modern medicine, there were zany experiments with ointments, insects and ground-up rhinoceros horns. The search for a female aphrodisiac is apparently as old as wooing.
What's taking so long?
With men, all a medication needs to produce is arousal, a.k.a. an erection. A guy will conjure lust on his own. A woman, on the other hand, can get aroused -- or have the physical signs of arousal -- and remain uninterested in sex. That's why Viagra doesn't work for the ladies, even though it produces roughly the same physical effect on them as on men. (In simplest terms, the drug rushes blood to the nether regions and creates the symptoms known as "hot and bothered.")
Arousal for women does not always lead to desire: Even Pfizer had a hard time grasping that concept. The company tested 3,000 women over the course of eight years before finally abandoning hope, in 2004, that Viagra itself could be the female Viagra.
"What we know is that very little of what's going on with women and sex is below the waist," says Anita Clayton, a professor at the University of Virginia's Center for Psychiatric Clinical Research and co-author of "Satisfaction: Women, Sex and the Quest for Intimacy." "Almost all of it is above the neck."
Which gets you to another complexity: If lust is "above the neck" for women, how exactly do you measure it? To win the pink Viagra sweepstakes, the FDA wants data demonstrating an increase in the number of a woman's "sexually satisfying events." But that's hard to define and fantastically varied, and it doesn't necessarily translate as "orgasm."
So pink Viagra must clear a higher hurdle than Viagra ever did -- it has to spark desire that also leads to satisfying events. To Clayton, it seems as if the government has set a standard that is unreasonably high -- perhaps because the government doesn't actually want to see a desire drug marketed to women, for vaguely puritanical reasons.
"It's as though the government is worried women will be turned into nymphomaniacs," she says. "Look, the FDA blocked the morning-after pill for ages. Why? Either they're worried we'll be bad girls, or they don't understand women's sexuality."
A number of drug companies say they can clear the FDA's bar, no matter how high. In January, 100 clinical trials began across the country for LibiGel, a testosterone gel made by BioSante. Women rub a dab of LibiGel into their upper arms once a day. (It builds up testosterone levels over the course of months.) There's also a German company, Boehringer Ingelheim, that discovered that a drug it developed for depression didn't lift anyone's mood but boosted desire in women. It hopes to win FDA approval for the drug in 2009.
The sooner the better, say many physicians in the field of sex medicine. They describe FSD as a kind of silent epidemic, particularly among post-menopausal women. Surveys on this issue, like just about every issue related to sex, vary widely in their results, depending on how you phrase the question. A recent paper in the journal American Family Physician combed through a bunch of surveys and decided that anywhere between 10 percent and 46 percent of women suffer from "hypoactive sexual desire disorder," a term often used for FSD.
Other studies have found that most women who are distressed by their sex lives are too embarrassed to discuss it with their doctors. Those who do speak up are often told they need a shrink.
"When I started this field in the '70s, 90 percent of the treatment was psychological," says Irwin Goldstein. "It was just assumed that every couple needed therapy."
The success of Viagra changed that. For decades, a guy who couldn't get aroused was thought to be "impotent," which carried the connotation that he needed to talk it over, on a couch, with a therapist. Viagra redefined impotence as "erectile dysfunction" and revealed that a lot of men didn't need to plumb their psyches at all; they needed greater vasodilation of the corpus cavernosum. In other words, they needed a pill.
After the launch of Viagra, Goldstein started organizing annual conferences to share research and ideas about FSD, then a relatively unknown diagnosis. About 500 clinicians, doctors and reps from the pharmaceutical industry showed up for the first Boston Forum, as it was called, in 1999. The media turned out, too. It was the moment FSD began to go mainstream.
It was also the moment that turned Leonore Tiefer into an activist. What bothered her, she says, was the idea "that women would be overtreated and given stuff they don't need that won't help." That a number of drug companies were underwriting the conference added to her sense that Big Pharma was simply cooking up a new malady, ravenously eyeing a new market. It was a criticism that would eventually gain some traction in parts of academia. An article in the Journal of British Medicine in 2003 called FSD "the freshest, clearest example we have" of "the corporate-sponsored creation of a disease."
But in 1999, the opposition consisted entirely of Tiefer and a dozen or so fellow travelers, who flew to Boston and strategized in a pre-conference meeting about how to voice their dissent.
"Someone suggested guerrilla theater, but I'm an academic, not a guerrilla theater person," Tiefer says.
Her debut, while not strictly speaking "theater," still grabbed everyone's attention. Here's how Goldstein remembers it: "She stood in the middle of the room and shouted."The Paradox
One recent afternoon, Tiefer is sitting in a leather chair in the midtown Manhattan office where she sees patients, mostly men and women with sexual problems. She looks younger than her 63 years and has a trace of the Bronx in her voice, which somehow adds to the sense that she is on the verge of putting you in a headlock. But headlocks aren't her style. Dry wit is.
She didn't shout at that 1999 meeting, she says.
"I didn't need to shout, because I had a very good point to make: That the meeting was window dressing for the pharmaceutical industry."
Tiefer led the quiet life of a Manhattan psychologist until 1998. She's been a feminist since the early '70s, she says, but when she got involved with a cause, she was always in the audience, not on the podium. Soon after FSD turned up, it dawned on her that she was as qualified as anyone to lead an attack. So she put together the New View Campaign, which now has a Web site, dozens of endorsers (such as the American College of Women's Health Physicians) and a manifesto.
Tiefer's argument can sound a little paradoxical -- it's clearly intended to help women, but at the same time, it tells women they can't have a medication that might enhance their lives. This raises some obvious questions, each of which she bats away.
What if women who are distressed by their sex lives really want a libido drug?
"Medicine is not a retail operation," she says. "It's not a consumer-demand issue. Just because people want things doesn't mean it should influence definitions, classification, research."
If pushed, she will agree that in the best of all possible worlds, yes, a medical option would be part of the vast arsenal of tools to help improve women's sex lives, along with therapy, couples counseling and so on. But this isn't the best of all possible worlds, she says. It's a world where the drug companies set the agenda, and if and when they start selling pink Viagra, it'll stigmatize women who aren't interested in sex, even if they're not bothered by that lack of interest.
Okay, but what if a drug company created a libido enhancer for women and sold it in a way that didn't imply that women who weren't interested in sex have a problem?
"That's like asking me, 'If people sprout two heads, should they wear two little hats or one big one?' I can't get with that assumption."
Mention Tiefer's name to physicians in the sex medicine field and they sound exasperated very quickly. To their ears, there is something self-interested in an argument from a psychologist who says counseling is the answer.
"Go back to the '50s and '60s and it was said that 95 percent of erectile dysfunction was psychological," says Andre Guay, a urologist in Massachusetts. "Then urologists get involved, and now we know that 95 percent of it is medical. That's taken a lot of people away from consulting with psychologists. They're worried about losing the other half of their business."
For the record, Tiefer says the number of men she treats has never even dipped. Perhaps talk therapy will always be part of any comprehensive approach to helping both women and men who want more lust in their lives. (All of Goldstein's patients see a psychologist who is part of his staff.)
But the more you know about what is happening in research labs around the world, the more the debate about female Viagra starts to seem a little quaint. We're getting closer and closer to understanding sexual gratification in its most basic chemical terms.
A small group of neuropsychologists, for instance, are using technology to pinpoint exactly what happens, biologically speaking, in the mind of women in sexual ecstasy. One of those is Barry Komisaruk of Rutgers University, co-author of "The Science of Orgasm." In his Newark laboratory he is at work on research that you really need a smock and a PhD to attempt. He's hooking up women to functional magnetic resonance imaging -- a kind of souped-up MRI, which tracks neural activity in real time -- getting a brain image as they self-stimulate.
He now has what is arguably the least romantic account of female sexual satisfaction ever: It's a flood of the hormone dopamine to a part of the brain called the nucleus accumbens. A pill that could produce that experience would be no substitute for a relationship, he acknowledges.
"And I see the potential for abuse by pharmaceutical companies, who have been guilty of creating illnesses to sell drugs. On the other hand, if a woman is distressed by the lack of sexual desire in her life and we can help her, why not?"