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FDA critics are finally having an aha moment

We now have booster shots aimed at the Omicron strains of COVID-19, and suddenly conservatives are realizing there's a downside to their endless yammering about how the FDA moves too damn slow. Michael Brendan Dougherty fills us in on the FDA's rapid approval of the Omicron boosters:

There’s a catch though: These boosters have been tested only on mice, not on humans.

....There was a libertarian and conservative vision of how the FDA should operate: more liberally, and faster please. They viewed the slow pace of the regulators as an impediment to discovery, innovation, and iteration....But there is another side to the story, which is trust. The faster that medicines are rolled out, and the less oversight they receive, the more room you have to make for public mistrust and doubt.

A very short time ago, it was nearly unthinkable to approve new vaccines without human trials. Now, we live in a world where ongoing booster mandates in some localities would oblige citizens to take a medicine that was never tested on humans or forfeit their access to public accommodations.

First off, Dougherty is wrong: Every year we all get flu vaccines that have never been tested on humans. It is assumed (correctly) that since the basic vaccine is safe, every possible combination of the vaccine against various strains of the flu is also safe. This is the same logic that's driving the fast approval of the Omicron boosters.

More to the point, though, is that everyone who's not an idiot already knew about the tradeoff between speed and safety. Am I being harsh? You damn well bet I am, and it's because the public reaction to the original vaccine approval pissed me off so much. Conservatives (mostly) could hardly shut up about how the FDA was a broken agency and there was no excuse for its sludge-like approval of the Moderna and Pfizer vaccines. But you have to run trials and analyze the data, and that takes time, we said. Bah, we heard back. A month earlier there was zero chance the vaccine wouldn't be approved. So why not just approve it then?

Does everyone now get it? In the case of the Omicron boosters, we're skipping the human trials and getting the vaccine out fast. Are you happy? Or are the dissenters on the FDA approval panel¹ suddenly going to become conservative heroes, leading to endless yammering about how reckless the FDA is? You can't have it both ways.

¹Yes, there is one.

41 thoughts on “FDA critics are finally having an aha moment

    1. bethby30

      They are having it both ways on the student debt forgiveness with those ads featuring working class people saying they should have to pay for other people going to college. There is a long list of powerful Republicans like Marjorie Taylor Greene and Matt Gaetz who got PPP loans forgiven.

      1. MontyTheClipArtMongoose

        Marjorie Taylor Greene at least operates a CrossFit gym. What business does Matt "Wooderson" Gaetz operate?

        Pretty sure that paedarast was fraudulently funding his prom wear & limousine rides for each of the fifty high schools where he plowed a lucky eleventh grader.

  1. AlHaqiqa

    I don't know about "The Conservative Media" which covers almost as wide a swath as "The Liberal Media". You can find people with differing opinions inside any media. When any person is internally inconsistent, it's time to ignore them. But I don't think you can claim that people inside those groups are personally inconsistent just because the group is. Or do you think everyone is a victim of groupthink?

    1. KenSchulz

      Well, then, also from National Review:

      On The Editors podcast, my friend Michael Brendan Dougherty observed that one possible way to mitigate the baby-formula shortage would be for the FDA to speed up certification of overseas factories.

      1. kennethalmquist

        Saying something is “one possible way” of mitigating the baby formula shortage is not the same thing as taking a position on what the FDA should do. Similarly, the piece Drum links to asserts that there is a tradeoff between speed and public trust, but doesn't take a position on how the FDA should balance that tradeoff.

        This refusal to take a solid position is inconsistent with the position that the FDA delayed approval of the COVID-19 vaccines unnecessarily. But as AlHaqiqa says, this simply means that not all conservatives agree with each other. It's not evidence of any conservative changing their mind about Covid-19, and thus Drum's title (“FDA critics are finally having an aha moment”) is unsupported by evidence.

        1. KenSchulz

          Yeah, right.

          Now, we live in a world where ongoing booster mandates in some localities would oblige citizens to take a medicine that was never tested on humans or forfeit their access to public accommodations.

          Wow, is the FDA making us human guinea pigs? Doesn’t this put our health at risk? But, I’m not taking a position, I’m just asking questions!

    2. ey81

      Yes, I think we are dealing with two different sets of conservatives: the libertarian intellectual set who think that the FDA is a bureaucratic monster hobbling the private sector (they think that about every government agency), and the working class don't-tread-on-me set who distrust vaccines whether promoted by Big Government or Big Pharma.

      1. Amber

        Probably also an age divide. Older people wanted the vaccine quickly while younger people and parents wanted reassurance that it would be safe.

  2. KawSunflower

    This makes me wonder if all those who have believed Kevin Drum to be too conservative or even (heaven forfend!) a Republican, will think that he's now taking his cues from the Nomoremisternice blog, getting his dander up.

    1. MontyTheClipArtMongoose

      No, I still think he's a Rockefeller Republiqan at best, Reagan Democrat at worst (& more likely).

      He's a white-centered codger who doesn't have time for all the #idpol. & if he were from fifty miles inland, would be the classic Bernie --> Trump voter.

  3. KJK

    The so called "conservatives" only cared that the vaccines were not approved prior to election day, so that their "stable genius" of a president couldn't crow loudly how he, and he alone, was able to get this done. Thereafter, those same "conservatives" did everything in their power to erode public confidence in the vaccines safety and effectiveness.

    I do remember when I used to vehemently disagree with conservatives on policy, but did not doubt their patriotism, adherence to the rule of law, and support of democracy.

  4. humanchild66

    I don't know what all of the fuss is about. The microchip didn't hurt going in, I barely notice it, and my loved ones find it extremely helpful to just be able to just call Hunter Biden's laptop to find out where I am at any time.

  5. DFPaul

    You have to admit that's pretty hilarious. You have to admit "conservatives" these days are just lost and wandering in the dark. Witness the endless criticism of the student loan debt thing as forcing the working class to pay for the educations of the rich. Any card-carrying KD reader knows the federal tax system is relatively progressive, thus the Biden program -- whatever your view of it -- amounts to getting the rich to pay the loans of people who took loans to go to school, and those people are -- by definition -- people who needed the money. So, taking from the rich and giving to people who need money. You may hate that, but don't throw this populist stuff at me about mechanics paying for dance degrees.

    1. Austin

      Come April 15, 2023, I'm sure there will be a lot of retractions and apologies online, on Twitter, etc. about how practically nobody's personal tax returns went up to pay for all the communism passed this year. Just like how we waged wars for 2 decades and nobody's taxes went up for that either. /s

  6. D_Ohrk_E1

    Actually, he's wrong in the first place.

    The bivalent Moderna MRNA-1273.214 (and presumably others, but I've only been tracking Moderna) has been tested on humans during Phase II efficacy trials. Moderna's study is on its investor relations website and on the FDA's server.

    What changed at the FDA was the elimination of Phase III safety trials for a proven technology. That's why they don't go through Phase III for other vaccines even when the formulation changes.

  7. Austin

    "More to the point, though, is that everyone who's not an idiot already knew about the tradeoff between speed and safety. Am I being harsh? You damn well bet I am, and it's because the public reaction to the original vaccine approval pissed me off so much. "

    There are lots of people in this country who have no idea how anything works. When covid first came out, a common refrain in my region was "why don't they have a test for this yet?" As if tests for viruses that nobody has ever heard of before are just sitting around in a warehouse somewhere. People are really ignorant, especially about science, but also generally on any topic that doesn't involve sportsball or a celebrity. It's not surprising that they could be led astray on the efficacy of vaccines... it's why we really need responsible people leading the government and speaking to the public, instead of the jokers and asshats we routinely get from the Ungovernable Tribal Regions.

    1. memyselfandi

      The UN approved a test on jan 27th 2020. There was vastly less testing availability in the US then every other civilized country, and even uncivilized countries if you include china in the last category.

      1. Rattus Norvegicus

        I'll attest to this.

        I got something which seemed a hell of a lot like COVID-19 in early April 20220. High fever, chills, chough, diarrhea, vomiting, the whole nine yards. Worst "flu" I ever had. Couldn't get a test. Sick AF for about 10 days, but testing was not available. The same thing happened to my sister in California. Doc told her the same thing: assume you had it.

        This was the single biggest failure in the US response: Not Invented Here syndrome.

  8. memyselfandi

    From the underlyng nationalreview article kevin citesThat has vaccine experts divided. Dr. Paul Offit, a member of the advisory committee, says this strategy makes him “uncomfortable” for several reasons. He notes that the data presented from Pfizer-BioNTech and Moderna in June involving their BA.1 booster shot, which focused on the levels of virus-fighting antibodies the vaccine generated, were underwhelming. “They showed that the neutralizing antibody titers were between 1.5- and two-fold greater against Omicron than levels induced by a booster of the ancestral vaccine,” he says. “I’d like to see clear evidence of dramatic increase in neutralizing antibodies, more dramatic than what we saw against BA.1, before launching a new product. We’re owed at least that.”
    An honorable auther, i.e. not one working for national revew would have noted that Offit got his wish as the vaccine being discussed here was not approved for this very reason.

  9. rick_jones

    I seem to recall a pundit lamenting the speed at which the FDA (CDC?) was approving new tests and the time it would take to certify new processors.

    1. D_Ohrk_E1

      Neutralizing antibodies may decline after 4 months but T-cell memory remains strong for years. You get sick but not that sick.

    2. Amber

      So you get the shot in November and you're covered for the holidays. It's not perfect, but it's better than nothing. And the protection against severe illness lasts much longer.

  10. Special Newb

    I'm pretty pleased. It can't make things worse, may make them better. Since my fellow citizens don't give a fuck about me I will pay what I need to get it.

  11. kahner

    Your underlying premise that any of these conservative critiques are based on any coherent, deeply held principle is just silly. FDA moves slowly: BAD! FDA moves quickly: BAD! FDA does anything: BAD! It's craven politics and disingenuous arguments all the way down.

    1. mandolin

      As Hanah Arendt has pointed out, his form of mental gyrations does not actually require "thinking," properly understood.

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