Derek Lowe is always the high-quality skeptic on all things pharma, and that’s a valuable role. Still, I feel like this isn’t really engaging with the issues:https://blogs.sciencemag.org/pipeline/archives/2020/05/01/why-are-clinical-trials-so-complicated …
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In other words, if there were a proliferation of sloppier trials, would the benefit of getting true positives sooner (& thus faster, cheaper drugs) outweigh the harms of people getting sick from ineffective or dangerous drugs that were reported as good?
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I could imagine a world where lower-quality trials were so useless that nobody intelligent believed them. In that case, legalizing them would be morally correct according to me, but a loss from a societal benefit perspective.
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Fortunately we have a great natural experiment right now! COVID19 drug & vaccine development is moving at much faster than usual speeds and skipping a lot of typical precautionary steps.
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If this “works” for generating drugs or vaccines that actually work, faster or cheaper than average, then we’ll know that there can be value in streamlining these processes.
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The reason a lot of the current minimum standards are set as they are is because they (or many others) used to be lower and people really did get harmed because of it. That's the whole 'c' part of cGMP
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I figure people got harmed! I don't think many rules are literally for *no* reason.
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