To: BigKNY3 who wrote (1643 ) 4/26/1998 2:17:00 PM From: Anthony Wong Read Replies (1) | Respond to of 9523
Today's New York Post: Now Women Catch Love-drug Bug By WILLIAM SHERMAN Women are clamoring to get their hands on the newly approved male impotency drug Viagra - for themselves. They're hoping the pill will do for them what it does for men - improve sexual performance. And manufacturer Pfizer Inc. thinks they may be onto something. The company - which just two weeks ago won federal Food and Drug Administration approval for the drug's use by men - has been conducting top-secret tests in Europe to determine if its new best-selling drug has a unisex application. A company spokeswoman said the drug has passed Phase I safety studies on women. Hundreds of female volunteers in several European cities are now taking the wonder pill in Phase II safety and effectiveness tests being conducted by scientists from Pfizer's research center in Sandwich, England. If the studies prove successful, the tests will be expanded to include thousands of women under the tough protocols required for Food and Drug Administration approval. The tests, which began earlier this year, won't be finished for some time, said the Pfizer spokeswoman, stressing that the results are not in yet on the drug's effectiveness for women. "This is a drug approved for use for men with erectile-tissue problems, and there is no scientific data to support its use by women," she said. But women here aren't waiting for the results. The chief physicians at several hospital-based sexual-dysfunction clinics in Manhattan said they've been bombarded with requests from women - some for information about Viagra, others for prescriptions for it. Several Manhattan pharmacists said they've filled Viagra prescriptions written by doctors specifically for women. There are no regulations to stop or penalize doctors who write prescriptions "off label" - for a use not specified by the manufacturer. "Off-label prescribing is a medical decision, and the FDA has no authority over that, so we have no comment on Viagra for women," said an FDA spokesman. Still, doctors who specialize in sexual dysfunction are cautious about the drug's effect on women. "I think Viagra will possibly have a significant role in women's sexual health," said Dr. Natan Bar Chama, director of Male Reproductive Medicine and Surgery at Mount Sinai Hospital. "The fact that Pfizer is going to trials on women means they have good evidence to suggest it will work, but we don't know what the side effects may be and we don't know if it will work." He added that in addition to getting direct requests from women, "husbands are also asking for Viagra for their wives." Dr. Jean Francois Edie, head of New York Hospital's erectile-dysfunction unit, said, "I've had calls from women - and I even had a call from one husband who begged me to convince his wife to take it, but I wouldn't do it. We don't have the criteria for female sexual dysfunction like we do for men." Dr. Ridwan Shabsigh, director of Columbia-Presbyterian Medical Center's Center for Human Sexuality also reported getting calls from women requesting Viagra prescriptions. "Theoretically it should work, because the causes of orgasm are similar in men and women," said Shabsigh, who directed Viagra tests on 40 men for Pfizer at the center. "We'll do the same tests on women," he said, "but my recommendation is, widespread prescribing for women is inappropriate right now." Other doctors interviewed, including gynecologists, were close-mouthed when asked if they were writing "off label" Viagra prescriptions, but they all said they knew other physicians who were. And some pharmacists are filling prescriptions for women, though others say they would not fill Viagra prescriptions for women because they feared it would make them liable in any malpractice actions.nypostonline.com