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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?

To: IRWIN JAMES FRANKEL who wrote (2153)	3/1/2002 7:32:18 PM
From: Cacaito	Read Replies (1) \| Respond to of 2515

IJF, the classic personal "would you take it" when a drug is being evaluated is completely irrelevant for the evaluation of effectiveness and/or investment. I would take Erbitux as part of a ramdomized, placebo control study, then I would have the chance of benefit myself and/or help with the creation of knowledge. The outside of trial compassionate care use is appropriate in certain cases. I would probably consider a drug out of desperation, like any other terminally ill subject, that says nothing about the drug, it says a lot about human condition. For the record, I have not objected to any of the compassionate use of Erbitux cases presented here or in the media. I do argue that they are very much irrelevant, as the oppinion of the clinicians involved, except for propaganda in this case. Go and check Allp web site (I am heavily invested on it, have made good money on it in the past) they have a cute girl birthday photos. She was part of the "matched" patients in the Liquivent study published in the NEJM on premature newborns, read the study, very impressive, 7 "close to death" ventilatory failure babies survived, the other 6 matched control babies died. Impressive 100% vs 0% results. Later a pII in adults gave mediocre results, the definitive pIII in adults was very good but just that placebo was better. Well, there is no development for cute little babies, and tens of thousands sick like the Allp birthday girl and more premature and weighing a lot less are being saved every year in the USA. At the time, I did not understand the big controversy about the lack of a prospective concurrent placebo control group very well, now it is very clear: It distorts the view and evaluation of drugs and creates more problems than solved. The birthday girl is PROPAGANDA (I own tons of the stock). I mentioned few posts before the problems of steroids in brochopulmonary dysplasia of premature newborns and recent Pediatrics journal position of US and Canada Pediatric Societies: no more use unless on ramdomized studies, they leave open an "Inform Consent" treatment for the severely ill close to death compassionate use URGING to be very strict in criteria to use.

To: IRWIN JAMES FRANKEL who wrote (2153)	3/2/2002 11:27:17 PM
From: Cacaito	Read Replies (1) \| Respond to of 2515

IRJ, Will You send an innocent man to jail, just because there is not a culprit one during a justice trial? The premise in clinical trials is the same as in a justice one: Innocent, until proven otherwise. A drug is non-effective (innocent) until proven otherwise, guilty (effective). In the legal system, guilty (effective in clinical trials) MUST be proven beyond reasonable doubt. In a clinical trial with the placebo control randomized prospective trial and multicenter is the equivalent of beyond a reasonable doubt. Statistics are to further enhance that the evidence is good and reliable (kind of good police/detective work). The market is to a drug in clinical trials as the tv followers of a famous trial in a justice one. Anecdotes are hearsay, even if coming from experts, maybe good for a civil trial, but not for a criminal one. In many trials, the previous conduct and even crimes of suspects are (sometimes, and very variably)kept from the jurors to keep bias from influencing outcomes. Anecdotes are hearsay, and the FDA accept anecdotes in the big reports from companies, but the evaluators try to keep them a little to the side. Erbitux is innocent (non-efective) until proven otherwise. As deffendants are to declared "non-guilty", it is irrelevant to them to be "innocent" or not, cause their problem is when "guilty, beyond reasonable doubt". It is irrelevant what many ask when their pet drugs are in trouble: "prove me it does not work" (innocent), the only valid relevant aspect is when "proven to work" (guilty). Lots of misunderstandings when one need a drug to be proven "guilty" to be approved by the Fda! And the first trial to go to the Fda just could not prove Erbitux guilty, only suspicious! Of course, one would not make one cent in the market following the analogy above !!!