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Biotech / Medical : Techniclone (TCLN) -- Ignore unavailable to you. Want to Upgrade?

To: Bob L who wrote (3117)	6/1/1999 10:33:00 AM
From: The Dodgy Ticker	Read Replies (1) \| Respond to of 3702

Here's a link to old news that I hadn't read before re the FDA and cancer drugs in trial: sddt.com

To: Bob L who wrote (3117)	6/2/1999 7:59:00 AM
From: Maurice Winn	Read Replies (1) \| Respond to of 3702

BobL, suppose a doctor decided that a new anti-cancer drug, Thalidomide, which might be approved by the FDA for a particular treatment for a particular cancer, might be suitable as an anti-nausea drug for pregnant women. The drug would have been properly approved and the doctor is using it properly, with good, but unproven, reason to expect efficacy in anti-nausea. We see immediately that the present FDA approvals process might not stop the disaster. The doctor's judgement might not stop it and the patient is ignorant so decides that the risk is probably low and accepts the treatment. Is anyone at fault? I think not. The patient made a mistake. The doctor, provided they had taken due care and was informed about possible risks which might be expected and had informed the prospective patient of these risks, would not be liable. So, in that sense, it is anarchy. Educated and expert anarchy, but anarchy nevertheless. Off-label treatment is anarchy. Let's have more of it! In the same way that doctors currently take responsibility for off-label use of products which are FDA approved, could they not take responsibility for any products the manufacturers come up with? They would presumably require similar standards of proof that the FDA does. But if faced with a person with glioma, they wouldn't need a huge approvals process to try thalidomide, Cotara or anything else which they thought was the best option. They'd just need their own judgement to be satisfied and the patient to agree to it, which is the same as the off-label situation right now. Maurice