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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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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Replying to @s_r_constantin
Yes, but are "we" all capable to take these decisions ? By that, I mean do we, like common people, have the knowledge to distinguish "good" from "crap" medecines in this very case ?
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Not everyone has to know about medicine themselves; they just have to decide which sources they trust.
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Replying to @s_r_constantin
IMHO, this is even worst. It means that these people should have access to different opinion about medecines (i.e. differents doctors), those opinions themselves not being biased by other factors... (Sorry if I'm not clear)
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