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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID -- Ignore unavailable to you. Want to Upgrade?

To: Scott who wrote (1425)	1/16/1998 1:33:00 AM
From: Maurice Winn	Respond to of 1762

Scott, We agree on the usefulness of FDA approval in doing broad brush vetting of products. But there are hundreds of millions of people who all have to wait and are unable to use applied thinking to their particular situation even if they want to, have the ability to and can afford the costs. The underlying problem in the medical world seems to be the centralisation of authoritative control. My preference is to have a voluntary system, so that people can choose to do what they like with their own bodies. If they choose to stick with FDA approvals because the FDA earns its reputation through performance and customer satisfaction, then that is great. But there is something grotesque about forcing people under your control even if they choose to do something else. There is a good enough record of wrong FDA opinion sufficient to show they should not have other than recommendation powers. If doctors don't wish to be sued, they should put in writing their recommendations, the risks the person thinking of undergoing the treatment will carry and if the doctor thinks it a dodgy experiment but the person will suffer or die anyway, then the doctor should be able to say to the person in writing that the treatment is dodgy, might kill them and there is no information to say that it will work. Get the patient to sign the papers listing the risks, and unknowns. That covers malpractice. I have no doubt that the FDA people try to do a good job, they are expert and all that stuff. But the fact is that they are only human with 1 litre brains. They don't have enough to handle all the problems and decisions in the world. This is the central problem between authorities and individuals. In this case it is costing lives in delays. How about malpractice suing of FDA - people who die because approvals were too slow? Poor bureaucratic process causing death. Rituxan must wait for the inertia of a trundling great medical fraternity to decide that use of it is not too left field. Its sales and profits will be slower than a free market medical system would provide. People who want to "feel a lot safer knowing that drugs have been passed through the gauntlet of FDA approval hurdles" could stay with that system. Others could go for the gamble. Freedom was once a byword of the USA. Maurice [I'll try to find where I read that some states are deregulating their medical processes a bit so people can decide for themselves in conjunction with a doctor. Thanks for your comments.]