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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: squetch who wrote (3676)	12/6/1997 5:58:00 PM
From: CYBERKEN	Read Replies (1) \| Respond to of 9719

Possible factor in FDA myotrophin decision: The review panel that refused to recommend did so, as I understand it, because myotrophin doesn't either cure ALS or slow it down. You still die at the same time, and a medicine that would help you there is still somewhere in the future. They gave no weight to the concept that victims of the disease suffer greatly prior to death and that myotrophin helps to limit that suffering. American doctors have been criticized in the past for failing to consider the symptom of pain an important subject for treatment (that's not "healing"). Part of the blame may belong to Cephalon and Chiron for not persuing myotrophin from the "relief of suffering" angle. I don't know if either company has commented on that at all. The point is that ALS sufferers appear to be well organized, and have decided they would like to choose the relief that this drug offers, and consequently can't see why the FDA would stand in the way of that, unless someone can prove myotrophin kills them faster. This is the kind of controversy that even the left-wing media would love to paint as government stepping on the "little guy". Disapproval would certainly help lay the political groundwork for round II of FDA reform. There is the strongest possibility that the FDA deosn't want the negative publicity of a disapproval regardless of whether they think it's warranted. Line of least resistance for the FDA::approve myotrophin and require that the label explicitly say that it's purpose is for relief of symptoms, rather than treatmemnt of the disease. If CEPH and CHIR then want to market it as a treatment, they'd have to do another trial and get approval for a label change. IMO: That sounds like a good, fair deal all around. Do you agree?