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Trump Unveiling Virus ‘Breakthrough’ a Day After Hitting FDA

Re: Trump Unveiling Virus ‘Breakthrough’ a Day After Hitting FDA

dave8383 said:
How new it is isn't the question. The question is is it useful in this case?
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Of course that is the question but calling it new is not correct. It is also of necessarily limited value since this plasma cannot be manufactured and relies on blood donations by recovered individuals.

Convalescent plasma therapy - Mayo Clinic
 
The FDA really looks bad on this one, and I’m afraid Hahn has really, really hurt its reputation. Internationally, the FDA has always been the most admired regulatory body, and talking with people today, this may really tarnish it.

If you listen to Hahn, he makes an incredibly bad mistake by confusing relative risk and absolute risk- stating 35/100 patients will be saved where the actual numbers are more like 5/100.

That number is already really, really tenuous since it comes from a post hoc analysis of a subgroup of a subgroup...and any data scientist in the world will tell you that’s just bonkers to rely on that as ‘real’ data.

But overall, this isn’t a horrific thing- it’s a treatment that might work, and needs more study to find out how to ideally use it (high dose? Earlier in therapy? Outpatient? Etc etc) and by issuing this EUA that will probably hurt further research.

It’s counterproductive because it will actually slow the research down and with Trump touting it, makes it seem more political, which might really hurt when it comes time to see a vaccine approval.
 
Threegoofs said:
This is really embarassing.

Confusing relative and absolute risk is getting Stats 101 wrong.
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Well, I have learned to lower my expectations over the last 3 years.
 
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