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While this is truly a sad event, there are some things to note here, primarily: This was a Stage 1 trial, whose sole goal is to determine the minimum-tolerate
by jszymborski 11y ago
While this is truly a sad event, there are some things to note here, primarily:
This was a Stage 1 trial, whose sole goal is to determine the minimum-tolerate dose. The idea here is that after we've identified a possible drug, we do preliminary tests in animals and follow some well established dosage-scaling formulas to determine human dosages.
They then scale that waayy down, and gradually scale up the drug in different patients until side-effects are noticed.
Although the article describes the patients as being healthy, people who volunteer for these types of studies usually have exhausted all possible alternatives and aren't usually given good prognosis.
If a study is conducted ethically, they aren't given any hope that the drug will positively effect them in any way, and that they are truly doing this for the possible benefit of Stage >1 patients.
Usually, toxicity is found before patients die (although that happens). What makes this unprecedented, imho, is that so many died. What makes it personally disheartening is that one is brain-dead, which is a special kind of hell for a family to go through.
While these patients weren't told "this drug will murder you, or maybe leave you brain-dead, with high-likelihood", however, in a Phase I trial, that is very much the risk you're running at such an early stage of drug development.
- dlandis 11y ago> What makes this unprecedented, imho, is that so many died. No one died from this trial.
- tremon 11y agopeople who volunteer for these types of studies usually have exhausted all possible alternatives and aren't usually given good prognosis. According to other comments here (e.g. https://news.ycombinator.com/item?id=10910698 https://news.ycombinator.com/item?id=10910698), this is incorrect. Stage 1 is given to otherwise healthy patients, to ascertain adverse effects of the drug. Stage 2 is where the positive effects of the drug are tested, that seems like the case you're describing here.
- jszymborski 11y agoYou are correct, and I beleive I mentioned in my comment that the sole purpose of Stage I is to asses the minimal tolerated dosage. What I meant by the sentence you quoted is that because of the unknown human physiological consequences of the drug, it is usually only used on those who have no other recourse. Patients that have a clear course of treatment undergo those clear courses, and do not assume the risk of a Phase I drug.