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A_D_E_P_Ttoday at 12:51 PM3 repliesview on HN

In medicine, observational evidence is actually better and far more ethical than the RCT. (Which simply dooms the terminally ill to fake treatment.) You just need large datasets and an agile culture that's responsive to new input.

Don't forget that RCTs are very far from perfect and issues -- sometimes literally fatal issues -- have later turned up via observational evidence in large cohorts. Vioxx, for instance. Many others.

I believe, without the tiniest shred of doubt, that the only trials drugs need to go through are initial safety/toxicity trials (phases 0/1) and that everything else would be much better left to access+observation.


Replies

taerictoday at 1:33 PM

This feels off. In medicine, any evidence can also be blinded by confounding factors that are far easier to miss without adding specific controls. Really, in any field this will be the case.

Should we demand an RCT before we accept evidence? Of course not. At some point you do have to make a choice on things.

And it should be noted that most drugs do have early cutoff criteria if the evidence is strong enough that it is working. It isn't like people are wanting to withhold good treatments from the world. Adding controls and randomizing them, though, has proven to be highly effective at helping progress.

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timrtoday at 2:40 PM

> In medicine, observational evidence is actually better and far more ethical than the RCT. (Which simply dooms the terminally ill to fake treatment.)

This is just nonsense. First, everyone in a trial is informed of the situation. It's not "unethical" unless you lie about it. If you participate in a trial, you do so knowing that you might not get the experimental drug. It's a selfless, honorable thing to do, and we shouldn't be framing it as some kind of scam.

Second, we don't give terminally ill people "fake treatment" (placebo trials). We give them current standard of care. Giving someone a placebo trial doesn't prove anything that would change clinical practice, because you want to know if the drug works better than what is out there today. Rarely is that standard of care "nothing", and this (bad controls) is actually a primary reason that a lot of drug company trials are rejected by the FDA.

If I didn't see the Wall Street Journal editorial board repeating the same garbage in defense of patent medicines, I'd write you off as simply having a sophomoric understanding of how trials work. I'm convinced that someone is driving this absurd narrative.

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naaskingtoday at 2:19 PM

> Which simply dooms the terminally ill to fake treatment.

I wish people would stop saying this. First, controls aren't necessarily "fake treatment", they are often compared to other standard treatments.

Second, the treatment being tested can actually harm the patient more, therefore the people receiving your alleged "fake treatment" can actually come out better off. Which is the "fake treatment" now?

I don't disagree with your final point, but mainly with this increasingly pervasive and wrong framing of RCTs.

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