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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Replying to @s_r_constantin
Wasn’t this experiment run before 1963 when drug companies just had to prove to the FDA that a drug was safe and not safe and effective? Seems we got lots of great new safe drugs that were effective at a low cost with this old approach.
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Replying to @Nucleics_Inc
What I know about the before/after Kefauver-Harris natural experiment 1.) Far fewer drugs were FDA approved after the law was passed 2.) the amount of illness from medication adverse effects did not decrease
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What I don’t know: 1.) what percent of drugs that *didn’t* have to prove efficacy to get approved, were later found effective in clinical trials 2.) an estimate of the medical harm (due to delayed/foregone medical treatment) from taking safe but ineffective drugs
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Replying to @s_r_constantin @Nucleics_Inc
It’s not surprising that Kefauver-Harris didn’t reduce adverse effects because drugs already had to prove safety. What we need to know is *how bad* it is for patients if ineffective drugs are on the market. (If doctors rarely prescribe them, for instance, little harm is done.)
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