[blindriver]

It'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.

[SeanLuke]

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.

[blindriver3]

Yes, he used his own data-driven judgement to override a bunch of career FDA scientists that were ready to approve a drug with a lower guardrails that made sense.

Americans who are 65+ years old only use the high dose flu vaccine. Moderna only wanted to test against the low dose vaccine, so we would have no data as to the efficacy of this new vaccine for 65+ year olds vs the standard therapy. Prasad demanded that Moderna include this.

Explain to me why this is wrong? Should we let multi billion dollar drug companies do what they want? Prasad did exactly what he was supposed to do, which is use his judgement to protect Americans. And Moderna did it, and now everyone is happy.

> He did so suddenly and without warning: the FDA up to that point had not raised any concerns about Moderna's trial protocol.

This is not true. FDA previously asked Moderna to add the results of the high dose vaccine and somehow it got removed. All Prasad did was insist on this. This was not suddenly and without warning.

[Arainach]

> Don't create accounts routinely. HN is a community—users should have an identity that others can relate to.

https://news.ycombinator.com/newsguidelines.html

[awakeasleep]

Is there a similar story behind that huntingtons therapy?

[blindriver3]

(For some reason I am being blocked from replying with my original account which is BS. Nothing I said was inflammatory or rude unless HN mods believe in groupthink.)

Yes, the treatment doesn't work and the studies show as much. But because people with Huntington's are desperate for any sort of treatment (rightfully so, it's a horrible disease), they don't want anyone to impede this therapy.

Uniqure is selling a so-called treatment to desperate patients looking for even a minuscule probability of a treatment and Prasad demanded that there be more evidence before the therapy gets more approval.

Uniqure's therapy consists of neurosurgery and injecting gene therapy deep into the brain. They claim that it slowed the disease but the same therapy compared to placebo had no better results.

Prasad was gain completely data driven, but to whoever just reads the news, they somehow believe that Prasad is against science which is complete bullshit. Everything you read about the therapy is that it doesn't work, and shouldn't be approved. He is PROTECTING us from bad drugs and therapy based on DATA.

https://augurbio.substack.com/p/unmasking-amt-130-hope-hype-...

[idiotsecant]

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.

[blindriver3]

No, they included only data from a study of 50+ year olds using a lower dose. But 65+ year olds don't use the lower dose flu shot. They ONLY use the higher dose for 65+ so why would the review go forward without this data? Why review a drug where we don't know how effective they are vs the standard treatment for the main group of adults (65+) that need it the most?

> Moderna acknowledged that FDA scientists had previously suggested that the company use a recommended high-dose flu vaccine in trial participants 65 and older. But the agency ultimately signed off on the trial design with the uniform standard dose, calling it “acceptable.” Moderna, meanwhile, agreed to add a comparison of a high-dose vaccine to some older participants and provide the FDA with additional analysis.

FDA previously suggested to use the higher dose vaccine as comparison for 65+ but for some reason they backed off it. Who knows why, but Prasad did the right thing. And Moderna added the data and now everyone is happy.

Are you saying that multi-billion dollar drug companies should just get a rubber stamp? What Prasad demanded was spot on, which is make sure that the trials include the group of patients that need it the most against the standard, high-dose flu vaccine. Again, explain to me why this is wrong?