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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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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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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My thought yesterday: What if all the clinical trials ever conducted happened just as they did, but were approved for marketing when safe. Would there have be an explosion in misinformation? Or would companies stop wasting time on ineffective things sooner without the sunk costs?
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Depends if docs/hospitals/payors still insisted on efficacy before they’d prescribe or reimburse.
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How do you view hydroxychloriquine through this lens? Crummy trial spurred better trials but also led to many hospitals including it in their algorithms and many patients taking it who (seemingly) didn’t benefit. It also consumed a lot of research and clinical testing effort.
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I would need to get a sense of the cost of doing one good trial vs many bad trials.
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Interesting thread—even if Indisagree with many of the conclusions. A couple comments: 1) Most (all?) consumers are super dumb (sorry!) and cannot tell good research from bad. Hell, most docs can’t! 2) Most regulations are the result of a previous error causing harm.
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