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Biotech / Medical : PFE (Pfizer) How high will it go?
PFE 25.05-0.1%3:59 PM EST

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To: James Baker who wrote (2407)5/12/1998 7:33:00 AM
From: MARIO PASQUA  Read Replies (1) of 9523
 
FEATURE-For some women, Viagra offers second honeymoon

By Maggie Fox, Health and Science Correspondent

WASHINGTON, May 12 (Reuters) - For Robin Lyles, Viagra offered a second honeymoon.

"It's really exciting," she told Reuters in an interview. "I can't describe how it makes me feel. I have only been married two years. I had my second anniversary in April. But my husband made a comment the other day, he said: 'I just got so used to not having sex that it doesn't matter any more.' I felt really bad because we're still newlyweds."

Viagra changed all that -- not for her husband but for her. Lyles is one of a handful of Americans enrolled in a clinical trial testing the blockbuster impotence drug in women.

The drug's effects on men who have "erectile dysfunction" has been trumpeted on front pages and the television news. In their third week on the market, the little blue pills made by Pfizer Inc. sold more than 200,000 new prescriptions.

Viagra has not been approved for use by women, but many doctors think it should be. University of Maryland urologist Dr. Jennifer Berman is one. She is starting clinical trials in a small group of women and says it is already having spectacular results.

Urologists, who specialize in treating the urinary tracts of men and women and male genitals, say there is no reasonphysiologically why women should not respond to the drug.

DRUG GETS BLOOD TO WHERE IT IS NEEDED

It works as an enhancer of arousal, getting blood to the penis when a man is sexually stimulated and allowing it to stay there. The result is an erection in men who have been unable to have one, usually for medical reasons.

The female sexual organs work in the same way. Blood must get to the area and stay there to stimulate the lubrication and other responses needed for a woman to enjoy sex.

Berman has given the drug to three women, two who had hysterectomies and one past menopause. Such women often say that sex is unpleasant and unsatisfying. But Viagra helped.

The female equivalent of erectile dysfunction is not as obvious as a man's inability to have an erection, and has no clinical name, but the symptoms are clear.

"It was uncomfortable ... the dryness after a hysterectomy," said Lyles, 39, who had to have a total hysterectomy after a serious infection, the possible result of treatments for infertility and endometriosis.

"Even if you are using lubricants, just forget it. It was such an effort to try to get things to function. And even if I did do it things didn't feel like they did before. Basically I gave up trying because when I tried it was so much effort and when I did do it it was to fulfill my duty, so to speak."

She said her husband was understanding and supportive, but she felt like she had let him down. "I'm kind of excited about it because it's like a new beginning," she said of Viagra.

DOCTORS SAID IT WAS IN HER HEAD

Berman described another patient who had a hysterectomy five years ago, who declined to be interviewed herself. "Ever since then she has had a lack of sensation," Berman said.

"She had been bounced around from gynecologist to urologist to psychologist, told it was in her head. She bought books and videotapes and did the whole relaxation thing. It was putting a significant damper on her relationship with her husband. He was disappointed, she did not fake it, and he knew."

The woman finally came to Berman, whose school had taken part in the clinical trials of Viagra in men. "Because I heard this same story from so many women following a hysterectomy, I decided to give her the medication," Berman said.

The results were better than good. "She had an unbelievable response. She said it was like it used to be, maybe even better. It feels like things woke back up. She was able to have an orgasm easily."

Berman, who has a grant from the American Foundation for Urological Diseases to study the physiology of the female sexual response, is delighted to get money for such a project.

"The fact that this grant was funded by this group, which is a very conservative, very academic group, when I was competing against people trying to cure prostate cancer, is kind of revolutionary within itself," she said.

Testing will take place only in women who cannot have children because the drug's effects on a developing fetus are not known. Experts estimate that 30 million American men suffer from erectile dysfunction. There are no official estimates on women but many doctors suspect the numbers are about the same.

Pfizer has Phase II clinical safety tests underway in Europe in a group of women but says it has no plans at present to include U.S. women.

Berman, who will do her study at Boston University, will also test other drugs in the women, including Vasomax, a pill made by Zonagen and licensed to Schering-Plough. Its active ingredient, phentolamine, also dilates blood vessels, and the company is expected to seek FDA approval this year.

MALES WERE GUINEA PIGS

"Males in this case were our guinea pigs. They had to go through the needles and the suppositories and the pumps, but now we are able to understand the physiology behind an erection and apply it to women and not start at ground zero," she said.

It is a badly neglected area. "Nobody has addressed it," Berman said. "Most urologists and gynecologists have traditionally been men. The questions that were asked were, 'Are you able to have intercourse and does it hurt' and if those things were OK they didn't press any more."

Research was not even allowed. "That's been the problem -- when we were talking about this earlier it engendered snickers and fears from our colleagues, even as scientists."

Lyles hopes the publicity will foster open discussion so more women can he helped.

"I think there's quite a few women and I think they never would be willing to say anything because that's such a taboo area and you don't talk about it like I've been doing," she said. "The reason I've been talking is that I want other women to get out there and say what's wrong and do something about it and improve the quality of their lives."

Sex was important to her and to her marriage, she said. "I think it's important to a lot of other women and they don't realize it." And, she added with a sigh, "Society wants to think, 'OK this is a man's problem. Women don't have those problems,' and that's simply not true." (<PFE.N> <SCHG.F>)

22:17 05-11-98
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