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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: Gene Voss who wrote (4318)	1/5/1998 11:02:00 AM
From: LoLoLoLita	Read Replies (1) of 23519

>>Regarding systemic damage from oral meds. Gene-- You have excellent comments. What I'd like some of the M.D.s to address are these questions: what constitutes "safety" for an ED therapy, and, is there a "lower bar" used by FDA etc. in assessing drugs for (IMHO) non-life-threatening illnesses? It seems logical to suppose that the "acceptable" level of bad reactions for ED therapies should be substantially less than what is considered OK for drugs used for chemotherapy, organ transplants, heart attacks, etc. I believe that recent recalls of a "diet pill" and an antihistamine are evidence that this may be the case. Will this affect the future of Viagra? My professional background is that of a risk analyst working on issues related to nuclear accidents. We constantly struggle with the question of "acceptable risk." I'd greatly appreciate any cites to journal articles or books on how this question is addressed in the drug approval/monitoring process. David P.S. According to Yahoo, VVUS has picked up a few new analysts, albeit with HOLDs; there are seven now. quote.yahoo.com

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