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Old 05-06-2005, 11:19 AM   #17 (permalink)
matthew330
Banned
 
1. No problem
2. Starting doses for phase 1 trials are determined by exhaustive, multiple pre-clinical trials.
"That included putting dangerous drugs into their bodies in doses not even approved for adults." This is a misleading statement. They didn't jump right in and feed them high doses of unapproved drugs and watched intently with their fingers crossed. DLT's - dose limiting toxicities. Once preclinical trials determine a safe starting dose, phase 1 trials escalate dosing in pre-defined stages (i.e. - no DLT's seen at this level in ? out of ? patients, move on to next). Once say, 3 DLT's are seen in 5 patients on one cohort, the maximum tolerated dose is determined to be the dose level prior to that. Yes phase 1 trials are risky, and no there are no guarantees. The problem doesn't appear (from the limited info in the article), the trial design, simply whether or not proper procedure was followed in enrolling vulnerable subjects (i.e. - minors). The problem is whether or not independent advocates were utilized or required.

It's as simple as that, and as far as i can tell this is not even a political argument. Your premature comparison of our govenment to Nazi germany is the only connection to this story and politics, i'm not personalizing anything - i'm addressing what is apparently your biggest concern in this matter. and trying to show why it is a completely misguided concern.
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