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Biotech / Medical : ICN Pharmaceuticals
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To: IRWIN JAMES FRANKEL who wrote (838)5/4/1998 5:53:00 PM
From: Clouseau  Read Replies (1) of 1029
 
IJF - Exciting indeed - I have been in this since 1994 and suffered thru the initial disappointment, so this is really nice. It was interesting to me that the enthusiasm for Intron by itself was very low, and even though the panel doesnt now know how the heck the combo therapy works, exactly, and even tho there are unpleasant toxicities (the Chairman at the end commented that one of the drugs is a known parenteral and the other is teratogenic - and dont ask me to explain!)...they slam dunked unanimously the recommendation for approval. The specific question on which they voted was "Is Ribavirin in combination with interferon alfa-2b recombinant safe and effective for the treatment of hepatitis-C virus?" There were some quibbles about the fact that they don't know the effect on the virus...ie does it kill it or change it to a nonthreatening form? Another guy expressed disappointment that there wasnt more data supporting dose optimization in the manner being done for HIV (again dunno what he was talking about). Several commented about the unknown long term effect (ie after ten years, say) but nevertheless, sufficient evidence was there to take the risk.

There is a study ongoing to determine dosage in which they are varying RBV from 400 to the 1200 mg now used. One letter from a Doctor, which was read, argued against SGP's recommendation to package the drugs together. He argued that Docs need to be able to vary dosage according to pt tolerance to side effects and other factors. Economics of the marketing will be affected by this factor. Also, it was noted that the approval would be for a pretty restricted pt population. They didnt let people in the study who had any of a fairly long list of problems.

I would be very interested to hear from someone who attended who also has more than my less-than-a-smidgen medical knowledge...and if anyone has questions, I can go over my notes to see what I might have jotted down.

Dave
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