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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID
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To: DMB who wrote (1435)1/18/1998 2:38:00 PM
From: Bob L  Read Replies (2) of 1762
 
As long as you are dropping in on this conversation, I thought I would too. You raise a very interesting point on "compassionate use" approvals. I have a different perspective.

My father has NHL. After the favorable FDA advisory committee recommendation for Rituxan in July, he inquired about treatment IND ("compassionate use") at both the large HMO where he is a patient, and a regional university medical center that had participated in the Rituxan trials. After some hemming and hawing, it became clear that none of the doctors were interesting in tackling the paperwork. One doctor said by the time they got approval for an individual protocol for my father, Rituxan would probably be on the market anyhow. These are compassionate and helpful doctors, not unreasonable people.

It took almost 4 more months for Rituxan to get final approval. I'm sure it wouldn't have taken that long for IND approval. But it shows the practical obstacles a patient faces in finding a willing doctor, a willing drug company, and getting FDA clearance.

Coulter, for example, says they are a small company and not interested in the burden of getting treatment IND approval for Bexxar. Perhaps this is justified by the manufacturing difficulties of a radioisotope-labeled product. I don't know. Eventually, my father got in the trial for Bexxar, but only after waiting months for his platelet level to creep from 95K to the required 100K. Any reasonable person in his position would have wanted to take the risk of treatment earlier. We understand the need for controlled studies, but not the need for dying while waiting for the results of the studies.

I wonder if there are any statistics for the number of seriously ill people who have successfully obtained treatment IND. I suspect it is the proverbial drop in the bucket. And many of those are probably AIDS patients, who are an organized group that has been pounding on the FDA for years.
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