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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 (1433)1/17/1998 4:22:00 AM
From: Maurice Winn  Read Replies (1) | Respond to of 1762
 
Scott, thanks for making that very clear and adding some extra information. This is all new to me and I'm paddling as fast as I can. I did understand what you meant as being what you restated.

My objection to the system was not that the companies seeking approvals were doing anything wrong. What you said makes perfect sense to me. What doesn't make sense is that doctors can know that Lupus is ready and waiting for the product which is held up pending approvals for some unrelated condition. I say why not just let the doctors loose and if they want to use something for Lupus with the patients understanding and fully informed consent, then leave them alone.

Why make everyone wait around while ingrown toenails show effective regrowth after amputations if Lupus is the actual target? That is just feeding bureaucracy to no effect. Safety levels do get partly demonstrated, but management of that risk could come from the contractual relationship between the doctor and patient. If the doctor can't say what the likely damage is from the treatment, then informed consent to likely death or unknown injury with set parameters could be given. When in the process of dying, most people would be more tolerant of a greater level of treatment risk than others would.

Also, I see my writing was sloppy, putting "maximum time" when I meant "minimum time". Sorry - see last post "..Fiddling around with strategies to maximize approval times as you mentioned in your last post instead of aiming at maximum human benefits is a joke. The drugs are meant to treat disease, not cure bureaucracy and feed the approvals system with millions of dollars."

Okay, I'm getting tedious on this one so I'll drop it. Thanks for your advice.

Maurice