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Biotech / Medical : Techniclone (TCLN)
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To: Bob L who wrote (3114)5/31/1999 4:58:00 PM
From: Maurice Winn  Read Replies (1) of 3702
 
Thanks Bob, but surely the whole point is for the FDA to approve all applications of the approved product? As a patient wondering whether to accept treatment with a product or not for a particular ailment, one would expect to see the imprimatur of the FDA for that particular ailment. If it is 'off-label', how is a patient to know that the FDA has approved the necessary clinical trials?

It seems a small cost to get labels updated so that the approvals are clearly written down. The manufacturer should bother to go back and get the label updated so that their products are properly identified and labelled.

If good, [whose definition of 'good'?] peer-reviewed published evidence is available supporting the use for an application, that still is far from FDA approved. It is a person knowledgeable in the field making an educated guess that the application is a good idea.

You said the uses may or may not have been 'scientifically proven' in the sense of peer-reviewed published evidence to support the use. If the case is they have NOT been thus 'scientifically proven', it seems an anarchic situation with individual doctors making decisions on applications.

Puzzled, and thinking the FDA isn't doing even what they claim to do = protect the public against unproven treatment. For a start, people are using all sorts of outright mumbo jumbo provided by 'alternative' therapists. Then, oncologists who have got some reasonable knowledge of the situation [though the field is too big for them to have more than a very approximate understanding] can apply treatments in off-label cases where there is not the FDA approved clinical trial base to substantiated efficacy.

Maurice
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