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April 25, 1998
Doctors Debate Use of Drug to Help Women's Sex Lives
Related ArticlesPfizer Drug for Impotence Leads Market (April 21) New Drug for Impotence Raises Hope for Its Use by Women, Too (April 4) FDA Approves Pill to Overcome Impotence (March 28) Impotence Drug Expected to Be a Popular Pill (March 28)
By GINA KOLATA
ETHESDA, Md. -- About 100 scientists from drug companies, academia and the Food and Drug Administration met in a hotel here Friday to ask a pressing question: If Viagra or a drug like it works in women, how would you know?
Viagra, of course, is the male sexual potency pill manufactured by Pfizer Inc. that the FDA approved for marketing this month to unprecedented sales. In men, Viagra works by increasing blood flow to the penis, enhancing erections.
Doctors say they are besieged by men who want the drug. "I am writing 15 to 20 prescriptions a day," said Dr. Stephen Auerbach, a urologist in Newport Beach, Calif., who attended Friday's meeting.
And, as every drug company scientist in the room realized, if a drug like Viagra is effective in women as well as in men who have sexual difficulties, what looks like an unheard of market could be doubled.
But the fundamental question, asked by doctor after doctor here, is: What is the female problem that Viagra or some drug like it would solve? Women complain about a lack of sexual desire or a lack of arousal or a lack of lubrication, but are they really complaining about a lack of blood to their clitoris or vagina? Do women even know it if they have a blood-flow problem?
Norman Mazer, vice president for clinical research at TheraTech Inc, a small drug company in Salt Lake City, stated the difficulty: "A man knows he has a problem. But in the case of a woman, she can perform. She doesn't necessarily think of herself as having a problem."
Although the actual definitions of female sexual dysfunction may seem elusive, those who were at the meeting agreed that women do complain about their sex lives. Large surveys in the United States and Europe have found that as many as 50 percent of adult women say that they have lost interest in sex or that they have difficulty becoming aroused.
Drug companies and individual doctors were clearly rushing into the female sexual-dysfunction arena.
Pfizer has started small studies in Europe in which it is giving Viagra to women. Dr. Raymond Rosen of Robert Wood Johnson Medical School in New Brunswick, N.J., has given a Viagra-like drug to a handful of women and measured their responses while they watched pornographic movies. Dr. Irwin Goldstein of the Boston University School of Medicine said he has already prescribed Viagra for a woman, despite the lack of data on whether it will work.
And Dr. Harin Padma-Nathan of Santa Monica, Calif., says he is going to start his own study giving Viagra to women. But first, he said, he must change the name of his medical center. It is now called the Male Clinic.
Treatments have been available for women before this, but they have not solved the problems for most women. Doctors have tried a variety of hormones. But, said Dr. Nancy Phillips of Robert Wood Johnson Medical School, "hormone levels do not clearly correlate with female sexual function or dysfunction."
Rosen spoke of a small "proof of concept" study. If he used a drug that increased blood flow to women's genitals, would it increase their sexual pleasure? He tested phentolamine, made by Zonagen in The Woodlands, Texas, a drug that is now under consideration, in pill form, to be a competitor to Viagra.
Rosen gave the pills to six women who said they had difficulty becoming aroused. Then he had them wear special tampons to measure their blood flow while they watched a pornographic movie. Blood flow to the women's vaginas increased, Rosen found, and they said they felt wet and had pleasant tingling sensations in their genitals -- responses they did not have without the drug.
But any idea of objectively measuring women's sexual responses as part of a large study gives rise to questions, experts at the meeting said. "How do you prove lubrication?" asked David Ferguson, a consultant to drug companies whose offices are in Grayslake, Ill. "Do you put tampons in their vaginas and weigh them when you take them out? Do you aspirate vaginal fluids?"
And where is it shown that blood flow to the vagina has anything to do with sexual arousal or desire, he asked.
The likely way of measuring a drug's effectiveness in women will be with questionnaires that ask women about intimate details of their sexual lives, drug company scientists and their consultants said.
Dr. Frances Quirk of the Rowertt Research Institute in Aberdeen, Scotland, who is a member of the Pfizer team that is evaluating Viagra, told of the company's efforts to develop such a questionnaire for women. It is the same strategy that the company used in testing Viagra in men, one that the FDA accepted.
Other doctors are going off on their own, testing Viagra in women without Pfizer's involvement, reasoning that once a drug is approved they can prescribe it as they see fit. That means that they can, if they want, prescribe Viagra to women. But they would feel more comfortable if they had some data on its effectiveness. Hence, the private studies.
But what happens if a desperate woman shows up tomorrow at a doctor's door?
Goldstein told the group about a woman who contacted him. She had had breast cancer and, in addition, her uterus and ovaries had been surgically removed. Sexual intercourse was extremely painful because her vagina was dry. But she could not take estrogen, which can help, because it could increase the chance that her breast cancer would recur.
So what did Goldstein do? "I gave her Viagra," he said.
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