To: DAVID who wrote (7949 ) 5/9/1998 9:16:00 AM From: DaiS Read Replies (1) | Respond to of 23519
David, Great idea - my suggestions for questions, 1) WHAT RESEARCH IS VIVUS DOING TO DECREASE URETHRAL PAIN? There seems to discrepancy between scientific reports (see below) where it is not portrayed as being that serious a problem and urologists opinion (eg Edderd who says price would shoot to 80 if the pain were eliminated. Nobody wants to tell me why you couldn't put a bit of local anaesthetic in the muse pellet. INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH, 1997, Vol.9, No.4, In terms of side effects the reported penile pain/burning-rate after MUSE(TM) was 31.4% compared to 10.6% after i.c. Alprostadil. (ANTI-MUSE paper) UROLOGY, 1997, Vol.50, No.5, pp.809-811 Penile and/or perineal pain occurred in 24% of patients (ANTI-MUSE paper) JOURNAL OF UROLOGY, 1998, Vol.159, No.5, pp.1523-1527 (VIVUS team) The most common side effect of therapy was penile pain, which rarely led to study discontinuation. NEW ENGLAND JOURNAL OF MEDICINE, 1997, Vol.336, No.1, pp.1-7 The most common side effect was mild penile pain, which occurred after 10.8 percent of alprostadil treatments, but the pain rarely resulted in refusal to continue in the study. (VIVUS team) UROLOGY, 1996, Vol.48, No.6, pp.851-856 The most common side effect was penile pain, which occurred in association with 9.1% to 18.3% of alprostadil administrations, depending on dose. Mean comfort ratings ranged from 79 to 87, depending on dose, where 0 = severe discomfort and 100 = comfortable. (VIVUS team) 2) WHAT RESEARCH IS VIVUS DOING ON NEW DRUG COMBINATIONS IN THE MUSE PELLETS? For example a start, JOURNAL OF UROLOGY, 1998, Vol.159, No.5, pp.1523-1527 Transurethral alprostadil and alprostadil-prazosin combinations produced erections in men with complete organic erectile dysfunction. This combination therapy may be an option in patients who do not respond to transurethral alprostadil alone.(VIVUS team) What about drugs in the pellet to improve uptake of alprostadil? What about testing use together of muse and viagra? 2. WHAT ARE VIVUS GOING DOING ABOUT PUBLICITY AND PRESS RELEASES? I) Viagra effectiveness overstated and overhyped? Look even at the Pfizer web site! Figure 1 on the viagra page is really intriguing though quite difficult to interpret. They pick on maintenance of an erection as variable to graph. My interpretation is that viagra is not effective for a large proportion of men who had problems during a 4 week pre-trial period but IS very effective in preventing recurrence during the test period of problems in men who in fact had no erectile problems during the pre-trial period. In other words, viagra is great if you don't have ED but not so good if your do. Figure 2 shows that the number of men reporting improvements above a median score increases with increasing dose of viagra but no quantification of the magnitude of improvement. You'd get that with three glasses of wine an hour before sex. II) Viagra bad side effects i) Headaches (16% according to Pfizer web site) Even if anecdotal evidence suggesting this an underestimate is untrue this 16% is no less than incidence of muse urethral burning. ii) Impaired vision (3% according to Pfizer web site compared with 7% for dyspepesia and 3% each for diarrhea and urinary tract infection) ".......sildenafil is only about 10-fold as potent for PDE5 compared to PDE6, an enzyme found in the retina; this lower selectivity is thought to be the basis for abnormalities related to color vision observed with higher doses ....." (Pfizer web site) iii) Delayed action of viagra - Pfizer must be terrified of this disadvantage over muse if they press release that they are working on a faster action pill. I hope it is not the case that vivus perceives that any negative publicity for viagra would reduce the coat-tail effect for muse. III) Legal actions against Vivus It is a disaster that all a prospective investor sees now on the internet news sources is a list of these class action lawsuit things - frightening, an incredible turnoff. 4) WILL VIVUS SEND INFO TO BOB DOLE Article from Daily Mail May 9 - `The potency pill worked its magic for me says Dole' "There are many men out there, millions of men, who suffer from impotence and this may be the FIRST step to a solution for them." says Dole (my upper case) Can't a bunch of you aggressive Americans go to this meeting and really shake things up? DaiS PS I have a lot of other scientific questions, anybody interested in corresponding.