alt Hacker NewsIt's really weird how many in HN such as you don't like Vinay Prasad.
He is 100% data driven. He has no ideology behind any of his beliefs or decisions, it's all 100% data driven. He should be worshipped by HN but instead he is vilified because many people on HN are the ones motivated by ideology or politics.
The decision to block Moderna's application was simple, they were comparing their results against a lower-dosage flu shot which no one in that age range (65+) takes.
Moderna agreed to add a comparison for the higher dose for older patients and then the application was allowed through. Why is this bad?
The media framed it as if the FDA backtracked but that's a complete lie, Moderna modified their application because Prasad looked at the study and rejected it because it was purposefully giving itself easier goal posts. He did EXACTLY what we want, which is don't make it easier for drug companies to give us bullshit, and to make sure that the drugs are doing what they say they are.
The loss of Prasad is a real loss for Americans.
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Is there a similar story behind that huntingtons therapy?
He's the opposite of data driven. Moderna did in fact include several studies together encompassing over 40 thousand patients over a diverse demographic group. In fact, they designed the study program only after the approval of the FDA was already given for it. It's a perfectly normal drug trial. This guy wanted his name in headlines and so he decided to just go ahead with 'vaccine bad' against the will of literally every expert the FDA employs to make these recommendations.
This guy got fired for a good reason - he's an idiot.
Note that Prasad didn't reject their application: he prevented Moderna from even applying. Prasad overrode a phalanx of FDA career scientists who had studied and approved Moderna's study approach and were ready to review it. He did so suddenly and without warning: the FDA up to that point had not raised any concerns about Moderna's trial protocol. He didn't cite any safety or efficacy issues.
This wasn't the only time he stepped in and overrode experts with seemingly no justification. Just the most prominent example.
I think it's good he's gone.