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

To: Tunica Albuginea who wrote (4435)	1/9/1998 11:49:00 AM
From: LoLoLoLita	Read Replies (1) \| Respond to of 23519

>>Redux; Rezulin;Seldane. All approved, but subsequent more >>data showed they killed too many people, and there were >>other alternative therapies so they got yanked off the market. TA, Bravo! I'm a risk analyst and software developer. Risk analysts, the smarter ones, know that their results/conclusions are ALWAYS affected by bias. Main contributors are two-fold: (1) economic interests (production pressure--"get that f'ing facility going!), and (2) the more subtle pressure to follow previous practices, right or wrong ("hey, if they did it before, it's probably OK, and who am I to rock the boat"). How do we deal with it? Simple. Independent review. Get enough "experts" together in a room, all with their own agendas and self-interests, and it's inevitable that any B.S. will get exposed to the light of day. How can you do this when research is privately funded, and contracts call for non-disclosure, etc.? I don't have the foggiest. It's up to the FDA to figure that one out. But, if they keep pulling "safe" drugs off the market, Congress may tighten the screws on them, so it makes sense that the decisionmakers will want to go slow, especially with treatments for non-life-threatening illnesses such as ED. I said I was a software developer. There too are parallels. Any software engineering text will tell you that programmers can't be tasked with testing their own code. Period. It's human nature to "test for success." That means programmers can spend many dollars and months devising elaborate schemes to "test" their own work, but, guess what, they almost always devise tests that show it works fine. Hand it off to someone who doesn't have a clue as to how it works internally and ask them to "make it crash" and guess what, they will succeed. FDA doesn't have the budget to do this kind of thing. They rely on Phase IV monitoring. We are the real guinea pigs! In the "real world" patients are not screened anywhere near as carefully for pre-existing conditions as they are in clinicai trials. Also, real-world patients are likely to deviate from recommended doses and frequencies MUCH more than you will find in clinical trials. That, I believe, is why these "safe" drugs had to be taken off the market. Could it happen to Viagra? David