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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: Gene Voss who wrote (4324)	1/5/1998 11:56:00 AM
From: LoLoLoLita	Read Replies (1) \| Respond to 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

To: Gene Voss who wrote (4324)	1/5/1998 2:26:00 PM
From: Zebra 365	Read Replies (3) \| Respond to of 23519

IT'S HERE!! Just in the mail this morning. A bright yellow cardboard box, 12"x9"x2", Return address Vivus, 1645 Oak Street, Lakewood, NJ 08701. Black letters on the outside, A WORD IN PRIVATE ABOUT A SUBJECT GOING PUBLIC... I'm too busy now to review the contents but I will later (epidemic of bad bronchitis in Dallas, we're double booked.) For now I'll just list the contents: - GLOSSY BROCHURE two-page 8 1/2 x 11 foldout yellow-on-black talks of direct-to-consumer campaign starting in February. Mentioned trained nurse educators available by phone to patients (saves your Time and lowers your Risk, Doc) - DUMMY MUSE SYSTEM (applicator, no medicine) on an 8 1/2 x 11 card with instructions on preparing the system for use. - MUSE product information sheet, same stuff in the 1998 PDR - MUSE patient information sheet, I'll look later. - VIDEOTAPE for in-office counseling, (probably a wink-wink, loan this out to patients) I'll look later. - LETTER from Alfred P. Spivack, M.D. Director Medical Services tells Dear Dr. Zebra: Roll out of consumer ads, 20 million men, 400,000 men have used it, BIG focus on LOCAL treatment. One Paragraph from the letter, my assistant is giving me the big frown <gg>: <<<Experts agree that erectile dysfunction is a local disorder.(NIH Consensus Conference ref) That helps explain why MUSE - a targeted medication with few systemic side effects or minimal drug-drug interaction potential and with a 5- to 10- minute onset--has become the #1 treatment prescribed by urologists for this indication.(IMS data ref) Quick, convenient administration allows for the spontaneity that patients prefer.>>> Again, the New Slogan as in JAMA ad: *Local problem, local solution...the answer is MUSE* Zebra P.S. I cannot emphsize this enough, as an internist, this would be the first time I have ever received any marketing material about MUSE. This came to me because I'm a primary care physician, not because I'm an investor. If it went out to all PCP's in the country, we are talking about 5-10 million dollars. This is what Leland would not reveal in the conference call when asked about PCP marketing.