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

To: BigKNY3 who wrote (19682)	3/12/1999 9:57:00 PM
From: Zebra 365	Read Replies (2) \| Respond to of 23519

BigK, Re: the Viagra/MUSE combination, I suggest you read the board above that you have been scrolling past to read the SI VVUS posts, particularly the last word that I put in almost a year and a half ago, (yes, I rewrote it upon the request of Frostman): <<Finally, most people in the scientific community expect the approval and marketing of Viagra to have an eventual positive impact on MUSE sales as these are likely to be complimentary treatments.>> Off-label uses of drugs are nothing new. I know you have never had the situation of standing eye-to-eye with a person who has come to you for medical help. When you know their problem backward and forward, and your basic science tells you that the combination of two drugs may work where either fail, you inform the patient of the risks and benefits and you do the deed, label or no. Combo therapy for Hypertension is old hat. Combo therapy for type II diabetes is new to the label, but I've been doing it for years before the labeling was there. I tell people all the time, "Medicine ain't golf, there are no rules except the main one, the needs of the patient come first". I see no reason that two drugs with different mechanisms should not be used in combination to lower side effects. To me it is like the gamma knife. Several atomic particle beams are focused from different directions so that they pass harmlessly through tissue but when they converge on a single point, the effect is devastating to the tissue (cancer or AVM) at the convergence. VLAD, I take umbrage at your remark that the vagaries of the market may make one "testy", I assume that this is a sexist slam at those of us (male) who have much more testosterone "testy" than the females do, thereby rendering us hopelessly aggressive and prone to attend Professional Wrestling Matches and Topless Bars. I expect an immediate retraction and apology to the DMA, (Domesticated Males of America). I also expect that you will never use the term "testy" in mixed company again. My wife made me type this. Don't lose your sense of humor folks; if you can't take a joke you shouldn't be investing in this company. Still Long, Zebra

To: BigKNY3 who wrote (19682)	3/13/1999 2:06:00 PM
From: DaiS	Read Replies (2) \| Respond to of 23519

BigK, Thanks very much for posting this abstract. If you typed this out for me that is very generous! The RESULTS section makes it clear that all the 16 men failed both on 100mg sildenafil and on 1000ug alprostadil. The experiment would hardly make sense otherwise. Although it might be tricky for Vivus to promote the combo, to me the result is highly important. For what the experiment shows is a huge positive interaction between the two drugs. Suppose that a proportion 0.25 of men had sufficient erections with viagra alone, and a proportion 0.125 had sufficient erections with muse alone. If we treat these values as probabilities then if the two drugs acted in a manner that was independent and multiplicative we would expect that, 16 x (1-0.25)(1-0.125) = 10.5 men would fail on the combo and therefore 5.5 men would get sufficient erections with the combo. If it happened that 10 men got sufficient erections on the combo then the difference 10-5.5=4.5 would reflect a positive interaction between the drugs. So we can break the 10 successes down and say that 5.5 derive from the direct effect of the drugs and 4.5 derive from the positive interaction. Neither Pfizer nor Vivus can claim these 4.5 successes as their own! On this basis in the present study we can say that of the 16 successes on the combo, 0 are due to the direct effects of the drugs and 16 are due to the interaction! The result is even more impressive given that the combo had 500ug not 1000ug of alprostadil. I suspect that there is a clear and massive synergistic effect that could not be replicated by increasing more and more the dose of sildenafil alone or alprostadil alone, rather than an effect of overcoming some underlying threshhold to create an erection. Now it would be very interesting to repeat these experiments with lower doses of sildenafil and alprostadil. I missed all the excitement because I was away the beginning of last week. You have made me aware that there are problems to be overcome in promoting the combo. But if you had told me on Thursday that there had been a pop to near 6, and asked me to choose the news, either, 1. Topical alprostadil for women 2. Combo gives 100% success on men failing both muse and viagra. I would undoubtedly have chosen option 2. DaiS