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

To: Pseudo Biologist who wrote (1430)	1/16/1998 4:36:00 PM
From: Maurice Winn	Respond to of 1762

Thanks PB, that was a busy ASH conference with lots of reading. Well worth while. Much appreciated. Re CD20, you are on pretty safe ground in saying CD20 is necessary but not sufficient. The simple body count supports you there. Complete or partial responses are indifferent to say the best for Rituxan. Adding I131 [Iodine 131] or Y90 [Yttrium 90] doesn't do the job particularly well either. But without information on the other determinants of Rituxan outcomes, CD20 seems to be the basis for narrowing the hunt. At least you get a lot better efficacy with it than with no treatment and the fatal collateral damage is near zero [isn't it?] so it might as well be poured in along with the cyclophosphamide, vincristine, adriamycin and prednisone. And add some Ascorbic Acid too! As well as cod liver oil and a bunch of retinoids. I gather from JDai and pals abstract that arsenic trioxide and other chemotherapeutic agents are more effective with ascorbic acid which increases cytotoxic or cytostatic activity. I read elsewhere about Vitamin E interaction with chemotherapies and the conclusion seemed to be that it didn't seem to stop the efficacy of the treatment, but they were uncertain. That was in the medical school library, but I can't recall the reference sorry. Variation seems to be the name of the game with the large B-cell non-Hodgkins lymphomas. Single bullets aren't going to work unless a common factor is found. So early detection, excision, CHOP, Rituxan, I131, Ascorbic Acid, Vitamin E, Retinoids, sleep, exercise, good diet seems to me to be the way to recover from NHL tumors. Comments? Of course, when available, TNT, antiangiogenesis instead of excision, maybe some selective telomerase inhibition. And a nice cup of tea! Plus don't get it in the first place and choose good parents, while avoiding whatever has caused an 80% increase in the incidence over 25 years. So IDPH doesn't have it all its own way. Lots of competition for Rituxan and minimal efficacy on its own. But for now, anyone with CD20 might as well be dosing up. Thanks again for the reference, Maurice

To: Pseudo Biologist who wrote (1430)	1/16/1998 5:01:00 PM
From: Maurice Winn	Respond to of 1762

PB, Just on the FDA saving us from ourselves and doctors. They are boasting about taking over a year to approve products. Working backwards from the number of people suffering the problems which these products will help, we could work out the number of people who died due to the delays. Fiddling around with strategies to maximize approval times as you mentioned in your last post instead of aiming at maximum human benefits is a joke. The drugs are meant to treat disease, not cure bureaucracy and feed the approvals system with millions of dollars. ----------------------------------------------------------------- The Food and Drug Administration said it sped up drug approvals in 1997 by as much as 20 percent. Management reforms and new laws to modernize the whole agency helped speed 35 major new approvals to market. The median approval time for last year's 121 new original drugs was 14.4 months, six percent shorter than the 15.4 months in 1996. Ten of the major approvals were for products containing substances new to the American market. The median time for first-time approvals in 1997 was 12 months, 20 percent shorter than the median time of 15.08 months required for such approvals in 1996. It said the most significant new approvals were for BeneFIX, a bloodclotting factor approved in February and made by Genetics Institute Inc which uses the body's own immune system to prevent rejection of kidney transplants. It also named Carticel, Genzyme's new process for repairing knee cartilage using a patient's own cells, Genetics Institute Inc's Neumega, which uses a hormone called interleukin-11 to help cancer chemotherapy patients and Infanrix, SmithKline Beecham's new diphtheria, tetanus and pertussis (DPT) vaccine for babies and small children. Drugs that got priority approval included Viracept, Agouron's new protease inhibitor for HIV which got okayed in less than three months and Evista, Eli Lilly and Co's new osteoporosis drug, cleared in less than six months. The remaining major biological approvals included software to enhance the safety of blood products, expanded indications for approved products and new manufacturing methods and technologies to improve the safety of biologics,it said. The Prescription Drug User Fee Act requires the FDA to act on new drug applications within 10 months by 2002. ------------------------------------------------------------------- Oh, the lawmakers are getting their cut of the cake too, passing laws to ensure human freedom from TOO much bureaucracy while creating the bureaucracy in the first place. I hope the courts and lawyers are getting their cut of the cake. Your cynical servant, Maurice