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

arstechnica.com

31–40 of 173 posts

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

#31
post #8

Earlier quoted context omitted.

> The subversion of scientific expertise to replace it with podcasters and political sycophants > The very concept of merit has been destroyed ... It's the subversion of truth. I think that way of saying it is more accurate, addresses the consequences, and is less occluded by jargon: People care about truth; 'scientific expertise' may seem esoteric to most people. I think HN is frequently part of that process: Merit…

How is discussion on HN different from the leadership levels at FDA? Very different. Decisions with enormous health implications, enormous financial implications, are made at FDA. At HN, most people are here to learn, here to understand more. Vinay Prasad is a fraud, completely unfit for the leadership role he was placed into, making baffling and arbitrary decisions on his own, overturning those with far more experie…

[deleted]

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

#32

The subversion of scientific expertise to replace it with podcasters and political sycophants is one of the biggest disasters of the current years. The very concept of merit has been destroyed and replaced with judgement calls on celebrity (necessary for leadership role) and subservience to the political whims of the last 15 minutes (and you had better switch in the next 15 minutes or you're out).

[flagged]

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

#33
post #27

Earlier quoted context omitted.

I would say that the US has had enough destruction of institutions and few enough institutional protections of individuals. I can dislike someone’s stance while at the same time recognizing that others benefit from the same protections. If protections are reduced, the process will be weaponized.

> If protections are reduced, the process will be weaponized This is a valid concern. So is moral hazard from a lack of accountability. I’m trying to figure out how those balance.

One way they should balance in a functioning society is that while tenure would protect you from negative repercussions within the walls of an academic institution, a Congress with any semblance of seriousness and care toward the American people would ensure you never set foot inside a policy-making institution.

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

#34
post #30

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.

The FDA regulates which drugs make it to market which is itself an extremely powerful force (excessively so) on conversations between you and your doctor.

In the case of vaccines, FDA's decisions can quite obviously make a difference in whether we have a rampant lethal pathogen roaring through our schools and killing our children and elderly... or not.

It's pedantic to the point of being outright false to say the FDA is not involved in major decisions of life and death. Silly take.

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

#35
post #8

Earlier quoted context omitted.

> The subversion of scientific expertise to replace it with podcasters and political sycophants > The very concept of merit has been destroyed ... It's the subversion of truth. I think that way of saying it is more accurate, addresses the consequences, and is less occluded by jargon: People care about truth; 'scientific expertise' may seem esoteric to most people. I think HN is frequently part of that process: Merit…

How is discussion on HN different from the leadership levels at FDA? Very different. Decisions with enormous health implications, enormous financial implications, are made at FDA. At HN, most people are here to learn, here to understand more. Vinay Prasad is a fraud, completely unfit for the leadership role he was placed into, making baffling and arbitrary decisions on his own, overturning those with far more experie…

> Mention you work on drug development for big pharma to the random person and they think you're evil

this is how Martin Shkreli described his work of identifying drug patents to buy that he could jack up the prices on. If that's the extent of the description you gave, I think random people would be right to first think you are doing something evil

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

#36

The subversion of scientific expertise to replace it with podcasters and political sycophants is one of the biggest disasters of the current years. The very concept of merit has been destroyed and replaced with judgement calls on celebrity (necessary for leadership role) and subservience to the political whims of the last 15 minutes (and you had better switch in the next 15 minutes or you're out).

“Scientific expertise” was already sold out to politics as we saw during covid. The further degradation to podcast bros is the cherry on top.

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

#37

The subversion of scientific expertise to replace it with podcasters and political sycophants is one of the biggest disasters of the current years. The very concept of merit has been destroyed and replaced with judgement calls on celebrity (necessary for leadership role) and subservience to the political whims of the last 15 minutes (and you had better switch in the next 15 minutes or you're out).

[flagged]

That might be true for some of them, but unfortunately I know a few anti vaxxers who also happen to be atheists. They just believe all the various conspiracy theories about vaccines.

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

#38

The subversion of scientific expertise to replace it with podcasters and political sycophants is one of the biggest disasters of the current years. The very concept of merit has been destroyed and replaced with judgement calls on celebrity (necessary for leadership role) and subservience to the political whims of the last 15 minutes (and you had better switch in the next 15 minutes or you're out).

“Scientific expertise” was already sold out to politics as we saw during covid. The further degradation to podcast bros is the cherry on top.

Both VRBPAC and CDC's ACIP did remarkably good work during the pandemic under enormous pressure - what specific complaints do you have? They got safe and effective vaccines out there fast, did a really reasonable job of balancing the cost benefit w.r.t. side effects of both j&j's and the somewhat elevated myo/pericarditis risk from moderna's vaccine in young men, etc.

Be specific?

(I have complaints - I thought Dr. Meissner was wrongheaded about opposing allowing EUA to extend to pediatric populations. But the committee as a whole functioned well and balanced the urgency of the situation with the need for voluminous data.)

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

#39
If Prasad thought this needed more research then it needed more research. He and the people he works with have written dozens, maybe hundreds now, of reports that expose studies that lack the rigor for definitive results, have misleading endpoints, have imbalanced arms etc. I get that anything that would slow vaccines down has somehow become political and lots of people would gladly accept the pharmaceutical companies word on things. This is a blindness due to political leanings and not evidence based. If Prasad says it needs more and better data I'd put money on it needing it.

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

#40
post #8

Earlier quoted context omitted.

> The subversion of scientific expertise to replace it with podcasters and political sycophants > The very concept of merit has been destroyed ... It's the subversion of truth. I think that way of saying it is more accurate, addresses the consequences, and is less occluded by jargon: People care about truth; 'scientific expertise' may seem esoteric to most people. I think HN is frequently part of that process: Merit…

How is discussion on HN different from the leadership levels at FDA? Very different. Decisions with enormous health implications, enormous financial implications, are made at FDA. At HN, most people are here to learn, here to understand more. Vinay Prasad is a fraud, completely unfit for the leadership role he was placed into, making baffling and arbitrary decisions on his own, overturning those with far more experie…

At HN, most people are here to learn, here to understand more.

There's a substantial "learn and understand" cohort, but there are other factions. At the start of the pandemic, there were 2 posters explicitly here to proselytize Trump style conservatism. I'm reasonably certain there was an anti-vaxx voting ring 2020-22, and I suspect there's remnant Elon fanboy and MAGA coordinated voting.

I'd love to be proved wrong on these things.

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