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

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To: Gene Voss who wrote (4324)1/5/1998 11:56:00 AM
From: LoLoLoLita  Read Replies (1) of 23519
 
re: Acceptable Risk

Gene--

As we in "risk space" would say, it appears that acceptability
is a "subjective determination by the decisionmaker."

I'd like to go further with this question, after first
acknowledging that quantitative (i.e., non-subjective) risk
acceptance criteria have a whole host of problems, and it's
not clear (at least in the nuclear/environmental field) that the
"subjective" approach is any better (or clearly worse) than
the "objective" approach.

OK, here is my question. Some time ago I asked the M.D.s to
comment on whether erection-enhancing drugs could come into
use by the broader population of "healthy males" who don't
meet the clinical diagnosis of ED. In brief, the very large
(IMHO) cohort of "2-15 minute men" who would like (at least
occasionally), to be "60-minute men." The answer I got was,
"of course this is going to happen, and it was discussed at
the urology meetings." This correlated very well with my own
experience BTW. Once Viagra is on the market with a big
marketing blitz it seems a virtual certainty that there will
be some diversion of the drug to "health males" wishing a
sex-enhancer. Some of this use of the drug will probably
fit the criteria for "drug abuse" with doses and intake
frequencies exceeding the recommended values. This could lead
to emergency room admissions reported to the Drug Abuse Warning Network, which would trigger both greater scrutiny by the FDA
for drug safety, as well as scrutiny by the DEA as to whether
the drug should be a Controlled Substance. This happened a
few years ago with anabolic steroids and testosterones, many
of which are now in Schedule III.

Could this happen with Viagra?

David
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