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Comment by darawk | Hacker News Reader

I suppose one counter-argument might be that if the data is public, drug companies would have more transparency into the FDAs methods, that might allow them to tailor their trials in a way to target the FDA's criteria in a way that would be bad for outcomes? Maybe?

But I come down on the same side, more transparency is probably better, and the FDA really probably only resists transparency here to avoid their own accountability to the public.

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Is that kind of secrecy useful in any way? No. It, instead serves to cover up abuses and oversights. Transparency, especially in government is essential. People should have privacy as their right, but the government should not.

Ya, I agree. Just trying to come up with the strongest possible counter-argument. Which may be that the FDA depends on some level of secrecy in order to prevent drug companies from overly tailoring their trials to their internal criteria. To be clear, I don't find that argument convincing, it's just the best one I could think of.

Drug companies already tailor their trials for the FDA. There are IND meetings with the FDA where they give you feedback on trial design.

Pretty much any “recommendation” they give is not really optional.

Which part of the FDA new drug evaluation process is secret? I have never heard of such a thing.

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