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Biotech / Medical : Biotech Valuation

CRSP 56.88

+0.9%

3:42 PM EST

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To: zeta1961 who wrote (19395)	3/21/2006 8:12:14 PM
From: Biomaven	Read Replies (1) of 52153

<why do you think that prohibiting placebo controlled trials is a mistake?> Clearly if there is an existing treatment that works for a serious disease, then it would not be ethical to have a placebo controlled trial. So we are only talking about serious diseases for which there is no accepted standard of care. So let's consider a real-life example. Consider the spheramine trial for Parkinson's Disease. That involves brain surgery, so it's by no means clear that the placebo patients are suffering a detriment compared with the active patients. If you ban placebo-controlled trials, then the trial would have to be run with historical controls. The only way to convince people that the implant was working would be to run massive trials - maybe thousands of people, because the comparison to historical controls is so difficult - you'd have to do some sort of case control study, matching each active participant with a similar non-participant. So at the end of the day, you'd need to subject a whole lot more people to a dangerous experimental treatment and at the end of it you'd still be left with more uncertainty than if you had allowed a placebo-controlled trial. The fact is that clinical trials require some degree of "public service." There's a balance to be struck between benefit to the participant and benefit to future patients (and the sponsor). In the example of spheramine I don't think there is much balancing to do as it's not really clear that the placebo patients are getting the short end of the stick. In other trials it might be somewhat different - but note that many trials in serious diseases allow for an active crossover at some point, even though this generally hurts the trial. Peter

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