“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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As long as that’s true, the case for high standards is a lot more sympathetic. Crappy studies are, indeed, crappy, and rarely worth betting a patient’s health on.
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But take a different extreme, for perspective. It’s totally legal to write a blog post saying “this drug worked for me!” The fact that this is legal tells you *nothing* about how much credence to put in the post. Free speech doesn’t come with a quality guarantee.
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It’s possible that if we allow more crappy studies *and amp up skepticism accordingly* there will be valuable signal amid the noise. Signal that we’re not allowed to generate today.
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I actually *agree* with
@Dereklowe that most attempts to make medicines that bypass the regulatory system are crap. And I appreciate his work in explaining to the public *why* they’re crap.1 reply 0 retweets 4 likesShow this thread -
The *ethical* position I take (which I know most people don’t agree with) is that you have a right & responsibility to decide for yourself what is crap. And if you want to take risks with your own health, that’s your business.
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The *empirical* hypothesis I’m making, which I *do* expect to be a question even skeptics should care about investigating, is that the “optimal” minimum standard for clinical trials is looser than the present standard.
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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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End of conversation
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