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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: Maurice Winn who wrote (1712)5/26/2000 1:10:00 PM
From: Richard Belanger  Read Replies (2) of 1762
 
Gidday Maurice

A common cliche is 'human life is invaluable' meaning human life is worth a lot. Well, if we judge by leisurely actions rather than words, we can't really say that's true. I'm sure the regulators would take issue with the 'leisurely' tag. It's due process to them, and indeed they are under enormous pressure to ensure that all new drugs produce the net positive benefit the applicant is claiming. Obviously, it is tragic when lives are lost in the course of this due process, although for low-grade NHL, I'm afraid it's more the case of precious months being lost.

Rituxan has been available for 2 and a half years. Zevalin is grinding ever so slowly through the linear regression analyses and FDA hoop-jumping procedures excruciatingly slowly. All grist to the highly-paid guild members of course. Yet oncologists seem still to be 'discovering' Rituxan with the % of patients being treated continuing to increase. There is still some reluctance to use Rituxan as front-line therapy and I can understand that. What I can't understand is why Rituxan isn't eventually used in ALL NHL patients who are relapsed or refractor to other therapies. It can prolong life with quality. There is nothing to lose! Aren't these oncologolists keeping up with their continuing education requirements? If Greg Rasp is listening, maybe he can comment on this from the onc. viewpoint.

Meanwhile, Zevalin seems a much better idea than Rituxan, so it's a puzzle that oncologists are happy to keep messing about with Rituxan when Zevalin seems a real method of dealing with lymphoma cells. It seems like the real hope is in combinatorial therapies. Zev treatment also involves Rituxan, and I would imagine there are many combinations of antibodies and radioconjugates that will eventually prove better than anything currently available. For example, each isotope performs optimally against tumors of a given size, and many NHL patients have multiple tumors with different sizes. So theoretically at least it would make sense to use a combo of isotopes. It's all very complicated, trying to determine optimal doses and treatment regimens. I guess that's why there's 150 Rituxan trials going on.

Indeed, Maurice, it is all very puzzling.

Rich
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