In the Pipeline
Props out to In the Pipeline, a blog by Derek Lowe who is an organic chemict and drug developer for a major pharmaceutical company. This is a valuable resource for anyone interested in, and with no idea how, the pharmaceutical company really works (ie. me). Apparently they're not always heartless monsters?
http://www.corante.com/pipeline/
Of particular interest as I was skimming through some posts I've missed was how the FDA testing guidelines for clinical drug trials are not enough to predict some side effects that might occur if millions of people take a drug...
"And there's the worry. There is absolutely no way that large enough clinical trials could be run on a drug like this (acomplia) to predict everything that might happen when millions of people start taking it. Can't be done. You can get down to a margin of safety that will get you past the FDA, but that isn't enough, now is it? No, if one person out of a hundred thousand has a nasty side effect, that's enough to bring the sky down on your head. And we can't test down to the level of one-per-hundred-thousand effects."
Food for thought.
http://www.corante.com/pipeline/
Of particular interest as I was skimming through some posts I've missed was how the FDA testing guidelines for clinical drug trials are not enough to predict some side effects that might occur if millions of people take a drug...
"And there's the worry. There is absolutely no way that large enough clinical trials could be run on a drug like this (acomplia) to predict everything that might happen when millions of people start taking it. Can't be done. You can get down to a margin of safety that will get you past the FDA, but that isn't enough, now is it? No, if one person out of a hundred thousand has a nasty side effect, that's enough to bring the sky down on your head. And we can't test down to the level of one-per-hundred-thousand effects."
Food for thought.
posted by Kaiser at 6:09 PM
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