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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID -- Ignore unavailable to you. Want to Upgrade?

To: Maurice Winn who wrote (1673)	7/15/1999 12:17:00 AM
From: Bob L	Respond to of 1762

I think the off-label use is mostly in combination with chemotherapy.

To: Maurice Winn who wrote (1673)	7/15/1999 10:30:00 PM
From: Bob L	Respond to of 1762

One thing that is unclear to me is what exactly is the definition of "off label." It is a term that is bandied about, but I haven't seen a real definition. Here is what I think "off-label" means, based on what I have read. I'd be happy to hear from anyone who has a better or more precise definition. I think "off-label" means any use other than that for the "indications" and "dosage" in the "label" required by FDA. The FDA statutes are more than a bit convoluted, not surprisingly. They date back to an era when adulterated food and snake oil "patent medicines" were the concern. The original statutes focused on disclosure to customer rather than regulation per se. So, to over simplify, you can't sell a drug unless it is properly labeled as provided by the FDA. And FDA won't approve your label unless you jump through all the requirement hoops for clinical trials, inspection of manufacturing, etc. So where is the "label"? I don't know for sure. But each drug has "prescribing information", aka the "package insert" that comes with the drug to the retail pharmacy. Genentech has posted the prescribing information for Rituxan at gene.com Therein, we find this indication: "RITUXAN™(Rituximab) is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma." And under "dosage and administration" there is no mention of combination with other drugs or treatments. There is a statement that the "recommended" treatment is once weekly for four doses. Therefore, it seems that there may be four general types of off-label use for Rituxan: 1. For anything other than relapsed or refractory low-grade or follicular. 2. In combination with other drugs. 3. For patients who haven't yet had chemo. 4. Using 8 cycles of treatment rather than 4, although I'm not sure whether this variation from the "recommended" treatment qualifies as off label. Lehman seems to imply most off label use is item 2, although I may be misreading their reports. In any event, since many of these patients are probably intermediate grade, some usage is off label under item 1 as well. I doubt much Rituxan is given alone to intermediate, since chemo is more effective with intermediate than low grade. I haven't seen any discussion of "off label" numbers other than from Lehman. I suppose from an investor viewpoint it doesn't matter. Clearly sales aren't limited to the indicated usage. So the market is bigger, which makes investors happy, and it is too early to tell how much bigger, because the exact boundaries can't be determined yet anyhow.