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

To: James Baker who wrote (6420)	12/3/1998 7:27:00 AM
From: BigKNY3	Respond to of 9523

Hard truths Alice Cairns 12/02/98 South China Morning Post 2 Page 24 Even the makers of tonight's deadly serious documentary about erectile dysfunction were unable to resist a pun in the publicity bumph which began with the words "Rising Expectations". As the Viagra phenomenon has demonstrated, male impotence has gone from being the last great taboo, to one of the most widely discussed subjects of the year. It is presumably in recognition of this fact that TVB has been positively thrusting (there I go now) information about The Truth About Impotence (Pearl, 10.45pm) at us. The programme comes with an unprecedented personal recommendation from Stephen Chan, TVB's programme controller. His minions sent preview tapes practically before I even had a chance to notice the show in the schedules, another first. This is not a programme about Viagra ; that comes at the same time next week. Instead it is an attempt to explain the causes of male impotence, using a team of sun-tanned American urologists, a handful of courageous sufferers and their partners, and a lot of computer-generated graphics. Viewers learn that impotence (euphemistic scientific term "erectile dysfunction") affects about half of all American men between the age of 40 and 70. Until 15 years ago the condition was so poorly understood scientists did not even know whether an erection was caused by muscles contracting or relaxing. Then a British scientist removed his trousers in the middle of a lecture and proudly showed the world an enormous erection he had achieved by injecting himself with a relaxant. He walked around the lecture theatre offering disbelievers a chance to see for themselves, and instead of being arrested, made medical history. Since then, researchers have come up with all kinds of techniques to help men achieve long-lasting erections, and all of them are described and demonstrated here. Half a dozen real-life patients not only discuss their symptoms, and their suffering, but in some cases allow their treatment sessions to be filmed as well. We get to see Jack, 59, who has blocked veins in his penis, learning how to use his new implants. And we meet a young couple who emigrated from Sarajevo four years ago, after the man was injured in a grenade attack. Sarajevan doctors told him he was never going to make love again. Well, what we actually see are the faces of Jack and the young refugee undergoing treatment. There is never a single glimpse of a real penis, hard or soft. It is an understandable omission, but given the frankness that makes the rest of the programme so unusual, it is a noticeable one. Would we get a programme about childbirth without seeing a vagina? Breast cancer without seeing a breast? Of course not.

To: James Baker who wrote (6420)	12/3/1998 8:34:00 AM
From: BigKNY3	Read Replies (2) \| Respond to of 9523

The MUSE clinical study presented at the 1998 AUA has been published in the December issue of the Journal of Urology. Noteworthy is MUSE's ability to lower blood pressure. In this study, "defined by strict criteria 41.2% of patients experienced orthostatic hypotension during in office testing". "One patient had a syncopal episode and fell in the office." As a result of these types of case reports, in March, 1998, the FDA required MUSE to revise their labeling. fda.gov BigKNY3 Journal of Urology, December 1998 DISAPPOINTING INITIAL RESULTS WITH TRANSURETHRAL ALPROSTADIL FOR ERECTILE DYSFUNCTION IN A UROLOGY PRACTICE SETTING PAT F. FULGHAM, JAMES S. COCHRAN, JOHN L. DENMAN, BRIAN A. FEAGINS, MICHAEL B. GROSS, KEITH T. KADESKY, MELVIN C. KADESKY, ANGELA R. CLARK AND CLAUS G. ROEHRBORN From the Urology Specialists and Associates, Presbyterian Hospital of Dallas and Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas Purpose: We evaluate the response to intraurethral alprostadil administration using the Medicated Urethral System for Erection (MUSE*) in unselect men with a history of erectile dysfunction. We determine the effects on blood pressure during in office monitoring and assess safety of this form of treatment. We compare the efficacy of MUSE in an office setting with the placebo controlled pivotal study. Materials and Methods: A total of 115 men with erectile dysfunction underwent in office testing with MUSE following the algorithm recommended by the manufacturer and outlined in the original pivotal study. Patients were asked to rate the rigidity of erection from 1 to 5 with scores 4 and 5 for erections sufficient for intercourse, and level of discomfort from 1 (very uncomfortable) to 5 (very comfortable) at 15-minute intervals. Patients who did not achieve a sufficient erection were scheduled to return for in office testing using the next higher dose up to 1,000 µg. Patient supine and sitting blood pressures were recorded by a nurse before and every 15 minutes after administration. Telephone contact with patients 2 to 3 months after the last in office testing was made to determine whether they were using the system. Results: Mean plus or minus standard deviation rigidity scores independent of dosage increased from 2.34 ± 0.99 at 15 minutes to 2.49 ± 0.96 at 30 minutes and decreased thereafter. Although the 1,000 µg. dosage resulted in highest mean score at all times, the differences between dosages were not significant. Rigidity score 4 or 5 was achieved in 13.2% (500 µg.) and 30% (1,000 µg.) of patients at 30 minutes. Mean level of discomfort was 3.6 ± 1.2 at 15 minutes and improved thereafter. Comfort levels were not significantly different among dosages. Overall, at 15 minutes 16.8% of patients were uncomfortable (score 1 or 2) and 41.3% were somewhat uncomfortable (1, 2 or 3). For all dosages supine and sitting systolic and diastolic blood pressures decreased significantly from before treatment to 15 minutes and stayed lower during monitoring. Defined by strict criteria 41.2% of patients experienced orthostatic hypotension during in office testing. A total of 21 patients had adverse events, including pain, discomfort and burning in the penis (the most common), dizziness and chest pain. One patient had a syncopal episode and fell in the office. At last followup only 18.6% of the tested patients continued to use MUSE at home, while the remainder discontinued treatment due to pain, insufficient erections for intercourse and cost. Conclusions: We were unable to achieve similar results to the pivotal study following manufacturer instructions and the algorithm provided by that study. Independent of age and etiology no more than 30% of patients at any given time using any dose achieved erections sufficient for intercourse during in office testing. Because of this limited efficacy, discomfort, pain and burning associated with treatment, and cost, more than 80% of patients did not continue to use MUSE at home. Key words: alprostadil, impotence, penile erection