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FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

arstechnica.com

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Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#71

Post by ted_dunning »

willmadden wrote: post #56

Flu vaccines aren't immunizing vaccines. They protect against specific strains, and half the time they immunize against a strain that doesn't become widespread and do very little or nothing to protect you. They have side effects which vary widely in severity depending on the specific vaccine. This article has no data about why mRNA flu vaccines will improve these outcomes, and has no data about the risk/benefit ratio…

Wow... that took me several, uh, seconds to find.

https://www.nejm.org/doi/full/10.1056/NEJMoa2516491

There's your hard data.

Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#72

Post by epistasis »

peyton wrote: post #30
epistasis wrote: post #18

Earlier quoted context omitted.

That is a good question, and I'm sure many of the people at UCSF are asking similar questions. However, his sort of misconduct is not the type that would usually violate tenure protections. Beyond the minor CV fibbing, without some evidence that he actually, say, solicited a bribe from Moderna, it's unlikely that he can face any sort of official sanction. The fraud is in his supposed thrust towards better scientific…

> he is so sloppy with major decisions of life and death To be clear, the FDA regulates marketing claims. “Is the label accurate?” Major decisions about life and death are between the doctor and the patient, not the FDA. It sounds like you’re taking an expansive view of this government agency’s mandate. People will push back on this at the ballot box, even if they can’t put it to words themselves.

Far more significantly, the FDA regulates what is allowed to be marketed as treatment at all, an influence that extends heavily into what types of validation studies are performed, etc.

Such decisions, what treatments are available, are far more widespread and momentous than any individual decision between a doctor and a single patient, because they affect all conversations between doctors and patients.

> It sounds like you’re taking an expansive view of this government agency’s mandate

It sounds like you don't know what the FDA does in practice. It is not my supposed "view" it is the basic factual reality of the FDA for decades and decades. (And if you are asking for my view, I believe it has the appropriate level of control of the industry, having developed products directly under their regulation. My personal experience with the FDA, and the experience of all the people I know in similar situations, has been with a very astute and scientifically meritous institution, that worked hard to make sure that products see fair and rapid evaluation. At least, up until what I have seen under Vinay Prasad.)

Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#73

Post by epistasis »

dlev_pika wrote: post #16
naturalmovement wrote: post #12

Earlier quoted context omitted.

Imagine being able to shut down discussion at the FDA because a few anonymous randos pushed a "flag" button when they saw something they disagreed with.

Apparently, the ‘fuck your feelings’ crowd DOES care about some ‘feelings’

They were actually clear about this, it's only your feelings that don't matter, not feelings in general.

In their minds there are two classes of people, and all of politics and law is about establishing the hierarchy. For the in group, the law is meant to protect and not bind, and the out group for which the law exists to bind but not protect.

It's clear in the language about "criminals" too. Actual convictions and clear corruption in the in group politicians? That's A-OK. An immigrant that is showing up for an official hearing? Time to be whisked away and treated with cruel and unusual punishment, whether or not their bureaucratic forms were filled out perfectly. (In particular I'm thinking of the immigration raid where South Korean professionals were helping to set up a battery factory and treated with chains as if they were violent criminals)

Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#75

Post by idiotsecant »

JSR_FDED wrote: post #44

How much death and suffering does this guy have on his conscience? I’m so curious how someone goes from being a professor to a science denier? I simply can’t imagine that journey.

I can definitely imagine it. It becomes so much easier to not worry about it when you have a comfortable pillow made out of lots and lots of money to rest your head on.

Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#76

Post by awakeasleep »

blindriver wrote: post #74
JSR_FDED wrote: post #44

How much death and suffering does this guy have on his conscience? I’m so curious how someone goes from being a professor to a science denier? I simply can’t imagine that journey.

[flagged]

Is there a similar story behind that huntingtons therapy?

Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#77

Post by blindriver »

datsci_est_2015 wrote: post #64
nfw2 wrote: post #61

Earlier quoted context omitted.

I lived in Manhattan in April 2020 and specifically know doctors who worked in the ER at Mt. Sinai. I think the vaccine mandates, to the limited extent there were any, were not paternalistic in a way that was unreasonable. I would not say shutting down all discussion about a topic (lab origin) that ends up getting vindicated is a minor scandal. It's something everyone observed that erodes trust at a national level.

> I would not say shutting down all discussion about a topic (lab origin) that ends up getting vindicated is a minor scandal. “Shutting down all discussion” - lol. I mean this is grossly hyperbolic. Were social media companies coordinating with the government to slow disinformation? Yes. Was it applied too broadly? Maybe. But describing it as “shutting down all discussion” is a disservice to people who don’t know as…

[flagged]

Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#78

Post by idiotsecant »

blindriver wrote: post #74
JSR_FDED wrote: post #44

How much death and suffering does this guy have on his conscience? I’m so curious how someone goes from being a professor to a science denier? I simply can’t imagine that journey.

[flagged]

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.

Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#79

Post by SeanLuke »

blindriver wrote: post #74
JSR_FDED wrote: post #44

How much death and suffering does this guy have on his conscience? I’m so curious how someone goes from being a professor to a science denier? I simply can’t imagine that journey.

[flagged]

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.

Re: FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

#80

Post by idiotsecant »

dboreham wrote: post #62
JSR_FDED wrote: post #44

How much death and suffering does this guy have on his conscience? I’m so curious how someone goes from being a professor to a science denier? I simply can’t imagine that journey.

Also interesting that there can be a giant asshole running a federal agency into the ground and I've never heard of him until now. Gives some scale to the problem. I also wonder what else is going on in government that falls below the widely reportable threshold.

It's like saying that one of the seagulls at the beach is particularly noisy.
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