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Biotech / Medical : Centocor ( CNTO ) -- Ignore unavailable to you. Want to Upgrade?

To: puborectalis who wrote (652)	4/14/1998 11:00:00 PM
From: FNS	Read Replies (1) \| Respond to of 965

Stephen: I am not an MD so I can not make any medical judgements. Unfortunately, I don't recall all the details as previously published regarding the Avakine study. However, I understand that there is strong opinion that the few lymphoma incidents were more related to the already suppressed immune state of the individuals in the study -- due to previous medications/treatments rather than due to Avakine. Again, this is what I read and understood from the various articles months ago! I do believe also that if Avakine were to have had any serious side affects that the study would have been stopped and/or potentially negative side effects immediately reported to the FDA. In any event, this seems to be an issue that needs to be resolved asap IMO.

To: puborectalis who wrote (652)	4/15/1998 8:01:00 AM
From: PawPr	Read Replies (2) \| Respond to of 965

Yes and no. Comment #653 echos my view. In many ways, patients with autoimmune diseases are inherently immunosuppressed; plus, they receive immunosuppressive drugs. Many of the cancer chemotherapy drugs are associated with an increased risk of lymphoma, so that per se does not mean a given drug is not approvable. The big question is, would the FDA approve such a drug to treat a benign condition ( if, in fact, they believed that the incidence of lymphoma is increased )? I would guess yes, since many of the same cancer chemotherapy drugs ( e.g., azathioprine, methotrexate ) are used to treat other severe autoimmune diseases. ( Of course, in the case of Avakine they would have the indication read as only for severe, recalcitrant disease ).