To: Tunica Albuginea who wrote (54 ) 2/6/1998 8:57:00 AM From: MissLil Read Replies (2) | Respond to of 1016
This is a summary of my previous remarks. Subscribers (and perhaps anyone) can read my previous posts listed under my profile. 1. From the limited data I have available (and I don't have any inside info), Viagra is likely to work in mild to moderate ED. However, it is unlikely to work in moderately severe or severe ED. Muse will be the drug of choice for this group. Injectable will be the drug of last choice but will pick up some people who won't respond to intra-urethral insertion. The doctors are bullish on this drug because we know, no way, will the pill work for the entire ED market. Intra-urethral insertion of combination drugs will probably work better than alprostadil alone. 2. Systemic therapy is a big unknown. Chances are all will be ok, but there is a significant, but small chance, that Viagra will be associated with significant side effects that will result in its withdrawal from the market or significant limitations in its use. I would estimate this risk at about 5% but, admittedly, that's a wild guess. I don't think anybody could do better without looking at the data, and even such a person couldn't know without the "Phase IV" trial of a million prescriptions. Comparisons with Persantine, etc. are possibly misleading due to dose-response issues. That being said, PFE is probably a good investment if one can get it at a good price (unlikely). Might be good to buy in February, wait for the expected approval in March (April or May if some minor problem develops), then sell on the expected surge after approval. 3. Any FDA reviewer who could not figure out what the patient population was would be fired or hung up by their fingernails. That may be the most persnickety (?sp) agency in the world, but they do know what they are doing. I learned a lot working there and wish I could have stayed at least another year (had to leave for family reasons) as it was very educational. Highly recommended for any clinician who wants to do research. Back on topic: the FDA will limit the indications for the drug to those populations in which it was tested, e.g. men with mild to moderate ED (I suspect). 4. Even men will mild ED may like to keep some Muse around. It works faster. So really now, what we need is someone to find out what that patient population was. Must be someone who knows or can find out. P.S. If Viagra works and is safe (i.e. one to two years of use without serious side effects), what's wrong with it if it helps men get over a little loss of confidence? O.K. so technically, it's not impotence, but who cares?