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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: BigKNY3 who wrote (2471)	5/13/1998 5:54:00 PM
From: Caroline	Respond to of 9523

biz.yahoo.com Wednesday May 13, 5:00 pm Eastern Time Major New Study Concludes Pfizer's Viagra Meets 'Ultimate Goal' For Erectile Dysfunction Treatment Outstanding Efficacy, Safety Demonstrated in New England Journal of Medicine NEW YORK, May 13 /PRNewswire/ -- Pfizer Inc's Viagra (sildenafil citrate) is the only approved therapy that meets American Urological Association treatment standards for erectile dysfunction, according to the results of two major clinical trials published today. The ''ultimate goal'' of an erectile dysfunction treatment is to be reliable, have minimal side effects and be simple to use, according to AUA treatment standards cited in the study published in The New England Journal of Medicine. ''Sildenafil appears to meet these specifications,'' the study concluded. An estimated 30 million American men suffer from erectile dysfunction, which is defined as the inability to achieve and/or maintain an erection sufficient for sexual activity. In an accompanying editorial, erectile dysfunction was characterized as a condition that ''can destroy a man's ego and threaten happy relationships.'' The availability of Viagra, the editorial stated, ''means that many more men will seek help for the condition.'' Viagra was tested in more than 4,000 men and was approved by the U.S. Food and Drug Administration on March 27. The first in a new class of drugs known as phosphodiesterase type-5 inhibitors, Viagra was demonstrated to work in about seven out of 10 men, including for both physical and psychological causes of erectile dysfunction. The FDA approval was based on safety and efficacy data from 21 clinical trials. ''These large-scale, long-term and innovative trials clearly demonstrate that Viagra is effective in treating this devastating condition,'' said Pierre Wicker, M.D., of Pfizer Central Research and a study author. ''We believe that these results will provide practical insights useful to physicians while expanding the scientific thinking in this emerging area of medicine.'' The article reported on two studies that included a total of 861 men with a broad variety of causes of erectile dysfunction, including organic causes such as diabetes and hypertension as well as psychological causes. The efficacy of Viagra, which was measured by a 15-item questionnaire completed by patients, was demonstrated regardless of the cause of the erectile dysfunction. Data indicate that Viagra significantly improved erectile function and the success rate of intercourse. In general, Viagra resulted in successful sexual intercourse 69 percent of the time, compared with 22 percent for patients receiving placebo. Viagra efficacy was maintained over the long term with about 9 out of 10 men opting to remain on treatment for up to a year. Prior to Viagra, treatment options were limited to penile injections and suppositories, vacuum constriction devices and surgical implants. ''Oral therapy permits discreet administration and is less invasive than some other treatment options,'' the study stated. In addition, Viagra is effective only in the presence of sexual stimulation, ''enhancing the role of the man's partner,'' the NEJM said. ''This publication clearly affirms that Viagra is a remarkable medical and scientific advance that will benefit many men and their partners,'' said Joseph Feczko, M.D., senior vice president, Medical and Regulatory Operations for the Pfizer Pharmaceuticals Group. ''As shown in these trials, erectile dysfunction is associated with many concomitant conditions. Diagnosis of erectile dysfunction therefore can provide physicians with insights into other conditions affecting their patients' health.'' Viagra was well tolerated. In the studies, the discontinuation rate for patients on Viagra was the same as patients taking placebo. The most common side effects are headache, flushing and indigestion. Viagra should not be taken by patients taking nitrates in any form, including nitroglycerin. Pfizer Inc is a research-based health care company with global operations. In 1997, the company reported revenues of about $12.5 billion and invested more than $1.9 billion in research and development. SOURCE: Pfizer Inc.

To: BigKNY3 who wrote (2471)	5/14/1998 6:46:00 AM
From: James Baker	Read Replies (1) \| Respond to of 9523

BigK, read the WSJ article on the Superstar of ED(I know you will). If this is representative of his way of off hand RXing of Viagra for elderly women with "driness" and actually suggesting sharing of medication he is headed for deep trouble for irresponsible medicine if not outright malpractice. Jim excerpts: Viagra Craze Gives Irwin Goldstein Superstar Status in Health-Care Field By LAURA JOHANNES Staff Reporter of THE WALL STREET JOURNAL Dr. Goldstein says he is trying Viagra on women because it is relatively safe and acts to improve blood circulation, which he believes can negate dryness, a common postmenopausal complaint. Clinical trials, which the FDA demands to prove safety and effectiveness, are just beginning for women. "We've tested Viagra for 3 1/2, four years in men, but I have to admit, I'm shooting at the hip as far as women are concerned," says Dr. Golsdstein. So far, he says, "we've seen some failures and some successes." An elderly woman sits demurely in Dr. Goldstein's office as he writes her husband a prescription for Viagra. Then Dr. Goldstein turns to her. "I know you're an Irish Catholic," he says. "But in the modern era, it's OK to talk about sex." He tells her Viagra can improve lubrication during intercourse, and asks if she would also like a prescription. She accepts. But once the doctor is out of earshot, she says she was "more than surprised" by the offer. Dr. Goldstein refuses Viagra to a man who is on chest-pain medication, telling him that mixing the drugs could cause a heart attack, and to a patient who wants him to write a prescription for a 70-year-old cousin in Turkey who just married a woman half his age but can't get the drug in his country. "That's illegal, I can't do that," he says, adding "You can share with your friend, but I don't want to hear about it."