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Biotech / Medical : Biotechnology Value Fund, L.P.

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To: aknahow who wrote (261)	8/28/1998 2:43:00 PM
From: scaram(o)uche	Read Replies (1) of 4974

George: preamble.... I've worked with FDA scientists. I've taken two clinical projects to FDA and worked with the agency for IND. Now, to answer your question..... Toxicity is not yes or no. There is a fine line that a regulatory agency needs to walk.... toxicity can't be studied in the detail necessary to say "ABSOLUTELY safe" in a time period that is consistent with rushing new therapies to patients that need them. Thus, drugs are approved and subsequently withdrawn when stuff shows up that testing didn't reveal. It's the risk you take. It is my personal opinion that it's not a risk that society should take if efficacy is not a portion of the equation. We could market sugar, in moderate quantities, for acne. The consumer would determine the market size, yes, but so would advertising. I have worked for a company that didn't have sufficient data to back a product. I have had a V.P. Clinical ask me "do you know how much money is involved?" I characterized "Centoxin" (HA-1A) from Stanford/Nelson Teng while I was at Bayer/Cutter. We returned it to Stanford and elected to pass on the license fee. It was subsequently licensed by Centocor. I knew what the "antibody" was. Centocor's trials were eventually halted, given that patients were dying at a higher frequency than placebo controls. If you take efficacy out of the approval process, I think that the frequency of death and serious consequences will go up. Toxicities are often not observed until AFTER an exhaustive search for them has been conducted. Why take that chance for stuff that would have the effect of sugar, when there are overzealous or just plain dishonest individuals out there trying to make a buck off of people's misfortune? No question..... the approval process needs to be reworked, and we need an agency that takes greater risk in the face of demonstrated efficacy. Recent changes at the agency have gone a tremendous way toward that end. There are people out there trying to cheat, George. Some of them don't care if they kill people. That's the real world. Rick

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