PASSION PILLS

A new crop of designer drugs in the works will allow you to pick a potion that
guarantees you good sex even if you - or your partner - don't much feel like it
by
Judith Newman
Ok, so it doesn't look much like a love nest. No candles, no Persian rugs, not one Barry White CD: just a drab hospital room equipped with a Barcalounger.

But romance--or at least its offspring, arousal--is what it's all about here at the Women's Sexual Health Clinic at the Boston University School of Medicine. This room is a testing ground for new generations of drugs to treat women who hove lost their zest for sex -- and therefore, suggest researchers at the center, for life.

Right now, the drug being tested is the one already proven wildly successful for men: Viagra. Here's what happens. A woman takes the blue diamond-shaped pill, then waits the requisite hour for the drug to work. She settles into the reclining chair and straps on a pair of 3-D glasses. For the next 15 minutes or so, she tunes in to an erotic video created for women (it has a plot), a movie with a title like Dinner Party II or The Bridal Shower. She is told to use a vibrator to excite herself--doctors are trying to make the conditions of sexual arousal similar from patient to patient. Before long, clinic director Jennifer Berman enters the room.

Berman, whose youth and blond good looks seem better suited to the catwalk than the science lab, gauges the woman's physiological responses using a variety of special instruments: an ultrasound device that measures blood flow, a pH probe that measures alkalinity, another probe to measure the lengthening and widening of muscle tissues, and a biothesiometer to determine sensitivity to applied pressure. The preliminary results of this ongoing study reveal that Viagra significantly improves sexual response in some women.

Berman and a handful of other researchers across the country are trying to answer a question that has puzzled humanity since Ovid first suggested onions were aphrodisiacs: What causes passion? And-- more important to the pharmaceutical companies investing billions in search of the answer--can it be bottled?

The introduction of Pfizer's Viagra last year ushered in a season of sexual reawakening for millions of men. If clinical trials are successful, Viagra will eventually be made available for women, although Pfizer has yet to announce marketing plans. In the meantime, numerous new drugs for enhancing sexual function--for both men and women--are in the pipeline. Pharmaceutical companies clearly heard the siren call of Pfizer's sales--$1 billion in one year--and they are answering with a vengeance.

To compete with the 800-pound blue gorilla, the competition must come up with drugs that do what Viagra does--increase blood flow to sex organs--but do it better. Or they must come up with a blockbuster pharmaceutical that does what Viagra definitely doesn't do--create a desire for sex, not just the ability to have it if you already want it.

The likelihood that drug manufacturers will achieve the latter goal is good, so imagine, if you will, pillow talk in the year 2003: "You're not in the mood? What does that mean?"

The story of scientific progress is often the story of serendipity, and that is certainly true with the new breed of designer sex drugs in the works. Just as sildenafil, the active ingredient in Viagra, began its life as a treatment for angina, so several of the new sex drugs originally had another use entirely--until some smart person figured out that those frequent erections being reported by test subjects weren't just the result of youth and good health.

Several of the new treatments being tested are, like Viagra, vasodilators. All strive for essentially the same end result of increasing blood flow in the genitals. And it is thought that these vessel dilators work in clitoral tissue just as they do in penile tissue. Each drug company working on a new vasodilator is trying hard to outdo Viagra. Zonagen's Vasomax apparently works in 15 to 30 minutes, as compared with Viagra's one hour. But only 30 to 40 percent of the men who try Vasomax find it helpful compared with about 70 percent of the men who try Viagra. A female version of Vasomax is also in the works. Testing of Vasofem, which may be formulated as a vaginal suppository rather than a pill, began last December. "We think vaginal delivery will increase blood flow and lubrication," says Jean Anne Mire, a spokesperson for Zonagen.

Apomorphine, another blood vessel dilator, has been used for years to treat tremor-causing Parkinson's disease. It turned out that many male Parkinson's patients experienced an unexpected side effect: improved erections. Apomorphine acts on the central nervous system, helping to send electrical impulses from the hypothalamus in the brain down through the spinal cord to increase blood flow to the genitals. Uprima, an apomorphine tablet from TAP Pharmaceuticals Inc., helped 40 to 60 percent of men who tried it in three tests. The tablet is placed under the tongue and works in 15 to 20 minutes. One drawback: It makes some users nauseous.

Tests on women began in July. "Eventually, apomorphine may be taken with Viagra," says Ragab El Rashidy of Pentech Pharmaceuticals, which is producing a sublingual apomorphine tablet for women. "Together, the two drugs should have about an 80 percent effectiveness rate."

With various Viagra copycats about to flood the market, the question for researchers studying female sexual dysfunction is: Will they really work for women? Because vaginal dryness and inability to reach orgasm are often found in women who have vascular disease, there's some reason to believe that insufficient blood supply to a woman's genitals impedes her sex life. So for women whose problem is lack of lubrication or narrowing of the blood vessels, vasodilators may provide some relief. In the United States 43 percent of women experience some form of sexual dysfunction, according to a 1999 survey from the University of Chicago, but they don't all have problems with their blood vessels. Some have problems with their libidos.

They'd rather be doing something altogether different.

Vasodilators like Viagra may restore physical function, but they cannot give a woman a sex drive. That seems to be the job of hormones. Specifically, the hormone we associate with the male sex drive: testosterone.

Certainly Carol Gruwell, a 43-year-old mother from Springfield, Illinois, is convinced. Three years ago she had two children, four dogs, two cats, and a very happy marriage. But her life changed abruptly when severe endometriosis necessitated the removal of her uterus and ovaries. She was catapulted into premature menopause--and complete sexual paralysis. "My husband and I had sex, but I was just going through the motions," she says. "I tried to hide my feelings, but I didn't even feel like being affectionate."

Standard estrogen replacement therapy to prevent hot flashes, mood imbalances, and the atrophying of vaginal tissue was not enough for Gruwell. Eventually, Gruwell's doctor recommended Estratest, a pill from Solvay Pharmaceuticals that combines estrogen and a testosterone derivative. In women, both the ovaries and the adrenal gland secrete minute amounts of testosterone--about 20 times less than the amount secreted by men. But researchers increasingly believe that this smidgen of hormone may be just as responsible for female libido as it is for its male counterpart.

Estratest has been on the market for more than 30 years as an alternative to standard estrogen therapy But along with a decrease in hot flashes, many patients were reporting an increase in energy and sexual enjoyment. The people at Solvay knew a good thing when they saw it. "About 70 percent of women on estrogen therapy alone discontinue use after one year because their symptoms haven't been relieved or they don't like the side effects," says Roland Gerritsen van der Hoop, head of clinical research and development at Solvay "Based on prescription renewal figures, loyalty to Estratest is much greater."

And now, no one is more loyal than Carol Gruwell. "At first, it was almost too much." she says. "My nipples became so easily aroused that for the first two weeks just clothing rubbing against me would be a turn-on." After about a year she lowered her dosage from two capsules to one a day, "which is still great but normal."

There is enough promise in hormone therapy so that even consumer goods giant Procter & Gamble is getting in on the act. Testosterone patches have long been available to treat hypogonadism, a condition suffered by millions of American men who do not secrete enough testosterone and generally have little or no sexual desire. In a recent study for Procter & Gamble and TheraTech Inc., Glenn Braunstein of Cedars-Sinai Medical Center in Los Angeles found that the patches, in smaller doses, restored energy and libido to some women whose testosterone levels were below normal because their ovaries had been removed.

Nobody knows the long-term effects of testosterone replacement. There is concern that increasing testosterone levels in women may heighten the chances of heart disease. One thing is likely: Companies will have to offer different patches with sizably different doses, because women seem to have quite a range of sensitivity to the hormone. Most women, like Gruwell, suffer no ill effects, but testosterone can sometimes cause acne, voice deepening, and hirsutism. So a dose that is one woman's lust producer may be another woman's electrolysis bill.

Perhaps the most startling area of hormone research involves work on PT-14, a peptide molecule derivative of a melanocyte-stimulating hormone that's being investigated by Palatin Technologies. The hormone is naturally present in the body It has several functions, among them the production of melanin to protect the nuclei of skin cells from the ravages of the sun. Norman Levine, a dermatologist at the University. of Arizona Health Sciences Center, was investigating the possibilities of giving the hormone to very fair-skinned people. He noticed that some of his patients were not only getting great suntans but also great erections. Earlier studies had revealed that the hormone, when injected by a catheter into brains of rats, "made the male rat get an erection and elicited a mating position in the female," says Carl Spana, chief technology officer and a researcher for Palatin. In a study completed in May, Levine and a urologist gave PT-14 to ten men with erectile dysfunction and found it helped nine of them. If additional trials go well for men, testing on women should begin in about two years.

Vasodilators require sexual desire to create an erection or vaginal lubrication; testosterone seems to create sexual desire. But a guy on PT-14 can be thinking about his income tax returns and still achieve a level of tumescence a character in a gothic romance novel would be proud of. "Normally, with an erection, as you start to think about sex there's a feedback loop: There's a subset of nerves that get stimulated, and the vessels in the penis undergo vasodilation," says Spana. "With PT-14, if your circulatory system is functioning, you get an erection whether or not you're sexually aroused. There are advantages and disadvantages to this. The drug may be for men who have impotence for purely psychogenic reasons." In other words, there's nothing wrong with their plumbing but the men may have some psychological hang-ups about sex. "But with PT-14," Spana adds, "an erection is pretty much guaranteed."

The fact that we might soon have an arsenal of pharmaceuticals available to treat sexual dysfunction begs a question: Do we need to medicalize yet another fact of nature, that some people don't have as strong a sex drive as others? Weight loss drugs suggest that you are ill--and perhaps irresponsible--if you don't slim down. Baldness cures suggest there's something abnormal about a shiny pate. Drugs for depression are targeted toward compulsive shoppers and the severely shy Are we using medicine to shrink diversity in the range of human behavior? And what will we lose if everyone's alike? If Henry James had had a vigorous sex drive, would he have only written greeting cards?

Certainly there is ambivalence among researchers about using medicine for social engineering. "If there's something that can be done to enhance a woman's possibility for reaching her flail sexual potential, I'm all for it," says sex therapist Laura Berman, who runs the Women's Sexual Health Clinic at Boston University with her sister Jennifer. "That said, there are a couple of potential backlashes. It's just like antidepressants. A person may suffer from depression for all sorts of good reasons--family problems, death of a loved one--and taking an antidepressant may relieve the symptoms but not the problems. Well, with drugs for sexual dysfunction, women can use them as Band-Aids and not resolve real issues in their lives--like abusive relationships or body image problems." In her practice, Berman already has women patients who ask for Viagra--for themselves--as a way of dealing with their husbands' premature ejaculations. Rather than slow the men down, which is easily accomplished without drugs, the women want Viagra to speed themselves up.

Berman also sees a risk that men and women-- but especially women--may begin to have unrealistic expectations of their own sexuality. "It's like the prevalence of breast implants has changed our expectation of what a perfect breast should be," she says. "These drugs could do the same thing. Women may begin to think that every orgasm must be super-powerful and super-easy in order to be correct."

Other health specialists fervently disagree. "This isn't about medicalizing--it's about improving our understanding of sexuality, particularly how men's and women's sexuality differ," says Marianne Legato, director of the Partnership for Women's Health at Columbia University in New York who ran a symposium this year on Gender and Human Sexuality in Washington, D.C., which was sponsored by Pfizer and Procter & Gamble. "We're on a quest for real information about female sexuality. For the most part, sexuality has only been studied in men."

An outgrowth of the symposium was a survey of 500 Americans' attitudes toward human sexuality; 92 percent of the women queried said that sexual enjoyment adds to quality of life at any age, and 60 percent didn't think waning sexual desire should have to be accepted as part of aging.

Carol Gruwell, for one, finds it frustrating that so many women she knows who've had their uteruses or ovaries removed still have not heard about vasodilators to make sex more comfortable or testosterone to make sex more desirable. The doctors who are used to thinking that a man without an erection is not a man are often the same doctors who think that a woman with sex problems is just ... well, either getting on in years or one of "those" women. "A man gets Viagra and the news is all over the world," says Gruwell. "But women have to fight tooth and nail for this stuff. It aggravates me."

SEXUAL DYSFUNCTION: THE GENDER GAP
[related article]

When Pfizer entered the world of impotence treatment with Viagra, there was a consensus on what male sexual dysfunction was," says Irwin Goldstein, a professor of urology at Boston University School of Medicine. "There were outcome parameters. International conferences existed in the field." But for women, says Goldstein, "we couldn't agree on what sexual dysfunction was. What if you can get aroused but can't have an orgasm? What if you can have an orgasm but generally don't get there because you feel no desire in the first place? What if you have three orgasms a week but want three per session?"

In an article submitted to the Journal of Urology, Goldstein and 18 leading researchers studying women's sexual response came to a consensus. They define four classes of female sexual dysfunction: lack of desire; inability to be sufficiently aroused, including problems with lubrication and sensation; problems having an orgasm; and sexual pain, including the involuntary contraction of the vaginal muscles and severe genital discomfort.

Given the myriad issues that may confront a woman, the treatment will most likely be more multifaceted than "Take pill. Swallow. Wait." -J. N.

DRUG TESTING: A LONG WINDING ROAD
[related article]

Wonder why Viagra costs a whopping 10 bucks a pill? Well, consider that a drug can take from three to 10 years to get to market, a gestation period during which expenses inevitably mount up. The new sex drugs must go through several testing stages. Phase I involves preliminary safety tests with healthy humans: Will the drug harm you? In Phase II, manufacturers move on to studies with larger populations to test effectiveness: Does this drug work? Phase III is the stage for double-blind, placebo-controlled studies in which some subjects receive the drug and some don't. This phase is crucial for Food and Drug Administration approval. Even after granting initial approval, the FDA often requires Phase IV as feedback comes in from the general population. "When millions are taking a drug, that's when you're really going to find the problems," says FDA spokesperson Laura Bradbard. -J.N.

 

DRUG NAME:	SILDENAFIL	PHENTOLAMINE MESYLATE
BRAND NAME:	MEN: Viagra WOMEN: None yet	MEN: Vasomax WOMEN: Vasofem
DELIVER:	MEN AND WOMEN:Oral tablet	MEN: Oral tablet WOMEN: Likely vaginal suppository
WHAT IT DOES:	Enhances blood flow	Enhances blood flow
POTENTIAL SIDE EFFECTS:	MEN: Headache, facial flushing, indigestion, hazy light blue vision WOMEN: Unknown	MEN: Nasal congestion, dizziness WOMEN: Unknown
STATUS:	MEN: Available. WOMEN: In Phase II trials. Earliest availability - several years from now	MEN: Finished Phase III trials. Earliest availability - late 2000. WOMEN: Phase II trials begin late 1999

 

DRUG NAME:	APOMORPHINE	ESTROGEN / TESTOSTERONE DERIVATIVE
BRAND NAME:	MEN: Uprima WOMEN: None yet	WOMEN: Estratest
DELIVER:	MEN AND WOMEN: Sublingual tablet	WOMEN: Oral tablet
WHAT IT DOES:	Enhances blood flow	Boosts libido
POTENTIAL SIDE EFFECTS:	MEN: Nausea WOMEN: Unknown	Nausea
STATUS:	MEN: In Phase III trials. Anticipated availability, mid-year 2000. WOMEN: Phase II trials began July 1999	Available now for relieving various symptoms of MENopause, Additional tests under way for effectiveness as a libido boost

 

DRUG NAME:	TESTOSTERONE PATCH	PT-14
BRAND NAME:	WOMEN: None yet	MEN: None yet WOMEN: None yet
DELIVER:	WOMEN: Dermal patch	MEN AND WOMEN: To be determined
WHAT IT DOES:	Boosts libido	Triggers response through nervous system
POTENTIAL SIDE EFFECTS:	Unknown	MEN AND WOMEN: Yawning and stretching
STATUS:	WOMEN: In Phase II trials. Earliest availability - several years from now	MEN AND WOMEN: Phase I trials expected to begin in 2000. Earliest availability - several years from now

 

 

Viagra
PT141
Selegiline
Bupropion
Melanotan
Yohimbine
Amineptine
Apomorphine
Testosterone
Phentolamine
Viagra: review
Violent 'sleep sex'
Prescription Drugs
Viagra: mechanisms
Phosphodiesterase 5
Sexual pharmacology
The Viagra Revolution
Viagra: clinical efficacy
Semen as an antidepressant?
Drugs to promote female sexual desire
Viagra leaves fake aphrodisiacs flagging
PT-141 (bremelanotide): the first aphrodisiac

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