“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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Replying to @s_r_constantin
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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