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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“Clinical trial regulations are completely unnecessary & don’t improve the quality of research at all” is a strawman. There might be some that are absurd, but in general, these rules are made by smart people, for actual reasons.
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Yes, CGMP rules ensure pure & stable drug samples. Yes, rigorous study designs make study results more credible. The question is: how much more credible, relative to the cost?
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Part of the problem is, once you have an FDA, it becomes *trusted*. Lots of doctors will immediately go out and prescribe any drug that’s FDA approved. People expect “approved” to mean “I can trust it.”
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Replying to @s_r_constantin
I don't think I've ever encountered a doctor who "just goes out and prescribes anything that is FDA approved".
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What I’ve heard is that *insurers* pretty much rubber stamp coverage of anything once it’s approved, and then marketing has a huge influence on doctors. I agree most docs i’ve spoken to are much more thoughtful but I may have a biased sample
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