What is the FDA Doing Now??!

My long-running skepticism about the safety and efficacy of the FDA is fast becoming conventional wisdom. Even normal people can’t believe what they are doing. This piece on the FDA in the New York Times reads like something I might have written for CATO.

An innovative coronavirus testing program in the Seattle area — promoted by the billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews.

…the program, a partnership between research groups and the Seattle and King County public health department that had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the Food and Drug Administration told the partnership to cease its testing and reporting until the agency grants further approval.

…the Seattle program …has wide backing, including from public health leaders, the Fred Hutchinson Cancer Research Center and Mr. Gates, whose foundation has been deeply involved in fighting the pandemic. The Centers for Disease Control and Prevention also provided an in-person technical adviser to the project.

Dr. Eric Topol, the director of the Scripps Research Translational Institute, who is not involved in the Seattle group, said it had “emerged as leading lights in this whole Covid-19 crisis.” He said it was “bizarre” that the F.D.A. would halt such a project.

By the way, Dr. Helen Chu, one of the leaders of the Seattle project, was one of the first Emergent Ventures prize winners for her work fighting the coronavirus (excellent pick, Tyler!). As you may recall, Chu started testing for coronavirus in an already running flu study without permission. Until she was shut down.

To repurpose the tests for monitoring the coronavirus, they would need the support of state and federal officials. But nearly everywhere Dr. Chu turned, officials repeatedly rejected the idea, interviews and emails show, even as weeks crawled by and outbreaks emerged in countries outside of China, where the infection began.

By Feb. 25, Dr. Chu and her colleagues could not bear to wait any longer. They began performing coronavirus tests, without government approval.

Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether.

The failure to tap into the flu study, detailed here for the first time, was just one in a series of missed chances by the federal government to ensure more widespread testing during the early days of the outbreak, when containment would have been easier. Instead, local officials across the country were left to work in the dark as the crisis grew undetected and exponentially.

History repeats itself, first as tragedy then as farce.

Addendum: I see now that Tyler covered this a bit earlier in the post below. I’ll leave this post up, however, as I have more details including Tyler’s connection.

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IIRC they threatened her with IRB violations. It was more than just “saying no”, the bureaucrats at the FDA threatened her with something that could cause her to lose her license to practice

Occham’s razor: Bill Gates is a known eugenicist and Malthusian. Someone in the FDA knows this. And he is a patriot. We don’t need crony capitalists cornering the market when they have made their eugenics plans known to all.

(90 seconds): Gates funded doctor says kill all white people who refuse vaccines: https://youtu.be/MsEIQzkcRZk

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This is kinda fun information. There's even one or two people with useful experience.

https://www.americanoversight.org/document/fda-political-appointee-resumes-since-january-2017

I dunno, I looked at the first 13 and I'd say that 10 of the 13 had relevant experience. That doesn't mean they had MDs (one did), were epidemiologists (none were), or had worked at the FDA before (I don't remember if any had, but the 10 with relevant experience had worked on issues involving regulation, deregulation, legal counseling, legislation, etc. of FDA or at least medical industry matters). In some cases their experience was only from the past several years rather than from a career but heck, people change careers all the time.

How many of our recent commanders-in-chief have had military experience? Since Jimmy Carter, we've had one WW II veteran and who had National Guard experience, that's it.

what I see is mainly lobbyists and congressional staffers working their way up the Washington ladder

a fair number of hacks and toadies, punching their tickets in the patronage system

i see very few actual managers or subject matter experts

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"Even normal people can’t believe what they are doing."
I don't know the reasons; I don't know the full story. Once again we have media articles to whip up some indignation but I'm getting tired of hopping on and off bandwagons. On this one, waiting for facts seems reasonable.

Agreed,the quoted parts show none of the reasons for the block, all I see is a list of all the great people that support the research. Isn’t credentialism something the author is opposed to?

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Any way to get a comment from the FDA on this? Even former FDA staff such as Dr. Gottlieb?

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In Australia when we want to break the law we break the law. If you broke the law to save lives and get brought up before a sensible beak, you get let off. If that doesn't work, that's what the pardon powers are for. Worse comes to worst, you saved lives in defiance of the law, which makes you like Batman.

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HIPPA...You cannot run tests on people's fluids without their permission.I'm pretty sure that's what the UW lab got in trouble for before. They'd recruited people for flu tests, and then decided "hey, we have a bunch of sick people and some might have had coronavirus. We could test those samples from December and see what we find"

but they never asked for permission to test for anything other than flu

Well, it’s a dumb regulation.

thats a funny thing to say in a nation that carries weapons to a state house because they are butt hurt over being asked to wear masks

Mask hate on? Now that’s a charitable reading of those protesters’ complaints!

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Well, speaking with Coase, if I own my fluids, why can't somebody buy them from me? :-) [Never gonna happen, friends.]

Given current rules, the Washington State bureaucracy approved of the testing program. The state authorities would have known about the FDA rules, yes?

More generally, if the non-approved use of my vital bodily fluids is used in a survey and nothing is ever done to me, there cannot be a violation of HIPPA.

If a personal susceptibility is detected, then the information should be made available to the owner of the fluids as a matter of efficiency, of course explaining the power of the test.

In that sense, speaking with aMichael, the regulation is stooooopid! Worse than that, actually. It does cost lives.

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This is almost certainly the key. Doing research without the subject's permission has been frowned upon since World War II (cf Josef Mengele, Japan's Unit 731, etc. -- and also the US's syphilis experiments on prisoners, soldiers ordered to watch nuclear explosions and exposed to radiation, Henrietta Lacks' HeLa cancer cells, etc.).

Giving up our privacy protections because "it's an emergency" or in the name of national security is something that should be done with extreme caution.

That being said, there's clearly a range of risks and rewards with human subjects research. For years there's been a movement to reduce the restrictions if the research only involves surveys and no physical contact. (Mental effects are a stickier issue; can a subject be harmed by a survey or an interview? In Ted Kaczynski's case the answer is clearly yes; he was abused indeed I would say tortured while an unknowing subject of a psychology experiment while an undergraduate at Harvard.)

And on the reward side, if there's a pandemic going on and these medical samples just sitting there, ready to be tested for the novel coronavirus, what harm is there in re-purposing those samples?

Some notion of expedited review seems to be called for. Institutional review boards, the boards that oversee human subjects research at their locations, already have expedited review procedures but they're aimed at research projects such as surveys that will clearly have no harmful effects.

But I would not throw out the baby with the bath water. HIPAA is one of the few remaining strong defenses of our privacy and the property rights to our own information about ourselves. To throw away those rights and allow open season for outsiders, government, corporations, researchers, etc. to have access to our data would be a mistake.

When I first learned about HeLa cells, I thought the whole controversy was dumb, and the need for regulation in the matter was dumb.

Who cares if scientists were using Lack's cells? It was saving many lives. Had Lack lived it might have been a different story

The family was literally asking for permission to halt that research and, effectively kill people, out of a perceived stigma that didn't exist. They shouldn't get a say, not when it's so valuable and the patient, despite best efforts, is dead. They shouldn't recieved compensation because it's not their cells. Those cells were only found in Harriet. And they didn't discover it, the doctors did.

Of course when I present that argument everyone thinks I'm insane, so I'd love to hear arguments to the contrary.

To your other examples, sure. I would say that not all of that falls under HIPAA though (and let's be clear, yes what was done to Ted was awful but the Unabomber made his own decisions. He is primarily to blame.) But sure, in many instances medical privacy is important.

And with things like DNA, where you can learn a lot about a person and can assign it to a name, privacy is paramount.

But if you have samples you discover interesting things on, and you anonymize them, well, you should be able to use them without having to go through countless regulations. They were not testing DNA here which is obviously different. That's what's at issue here.

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"What is the FDA Doing Now??!"
Probably something silly. Now I'm not saying we junk the FDA, but they need to be reigned in a bit.

apparently that’s out of the question. the fda is a rogue agency beyond the control of even presidents, or so we are told.

who can rein them in. no one! Bwahaha!

Lol public choice as rogue agency.

The world through the eyes of a child

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Alex is a “libertarian” but censors opinions critical of him. Alex, come outside when you’re ready to behave like an intellectual. You apparently won a doctorate but simply do not behave on this blog like a man of letters, a man of the west, a participant in the life of the mind. We’d love to have you, but maybe humans really are just automatons without ability to transcend. Please prove me wrong.

Can we at least explore the incentives that drive the regulatory decisions that drive you to puerile outburst? Forgive me if you have already done so ad nauseam, as perhaps you have. I’m no sycophant for the bureacracy; I am just looking for rigorous content when I visit Messr Cowen and your blog. The internet is a cold, empty place; let’s pledge to something higher and nobler.

I forgive you for your indecipherable outburst.

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Is it possible that someone high in the government wants fewer tests because tests make the numbers look bad? Has any high ranking official said something like that at a press conference on TV? Like in March, while Dr. Redfield was standing there?

Yes. Someone very high in the government. He has told us directly.

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You have to consider that the FDA stopped Seattle's testing for political reasons. Trump toadies strike a blow against Bill Gates and Democratic governor Inslee. The right wing has already targeted Bill Gates. He's getting death threats. Note also today another Inspector General was fired.

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A good first step would be to stop treating “ the FDA” as a black box machine. A person made this decision. Find out who that specific person was, and ask them to explain / justify it.

My money's on some lady bureaucrat whose book club read "The Immortal Henrietta Lacks."

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No no no, in Atlas Shrugged, the bureaucrats are faceless nameless relentless zombies who are impervious to efforts to control them.

Central Casting has been specifically instructed to only cast vague nefarious characters, who have no actual job descriptions or lines of reporting.

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They are making perfect decisions to protect FDA fiefdom. They are achieving the agency's prime directive of growth and survival and whether thousands die as a result, they have covered their bureaucratic asses.

The situation can't be cleaned up without firing half their staff or destroying the agency and starting over.

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Alex's pdf reveals the delays & outright interference that boggles the mind to the extent that people would probably/actually be better served by the medical pros w/out FDA participation. Maybe not 100% but who can tell???
As he suggests - New drugs are regulated quite differently than new uses of old drugs. On balance, however, consumers have benefited from the lack of FDA “protection.”
I’m sure there are reasons FDA approvals are valid & necessary but this period of CoVid is gonna’ be an embarrassment over time...

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A further point Alex makes is pretty damning...
'The debate over off-label prescribing is not about perfect safety; it is about whether unavoidable trade-offs are best made for everyone by a centralized authority such as the FDA or whether those decisions are best made by patients and doctors acting independently. Whoever makes a decision to try (patient), prescribe (doctor), or approve (FDA) a drug must face the trade-off between the costs of prescribing a potentially unsafe medicine (a type II cost) and the costs of not prescribing a drug that could have saved a life (a type I cost). The FDA tends to overemphasize the cost of using a potentially unsafe medicine, because type II costs are highly visible and result in punishment of the FDA, whereas type I costs are invisible and do not result in punishment.'
Sad commentary on FDA thought process...….

What you write is utter nonsense. FDA has no regulatory authority over off label prescribing other than perhaps the distribution of warning information if the on-label use requires that. What they do have is regulatory authority over advertising of off-label uses. What is wrong with that? Don't you want confirmatory evidence that the on-label use works and is safe for that indication? I see no inherent conflict other than a lot of people who write about this have no clue what the regulations actually say.

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Dear Libertarians: The FDA is not an imperial authority. The President can and does tell these agencies what to do. Please look at the EPA for an example of his power to pollute by communication. So direct your stunned wrath where it belongs.

Dear Statist,
If u think any President has full authority over a fiefdom 1000’s of bureaucrats all making Big $, who can’t be fired, you believe in unicorn theology (ie great man theory).

Cc Garret Jones

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A good dissertation topic is a cost-benfeit analysis of the FDA over its entire history. Possibly, all the good from 1906-2019 is cancelled by its 2020 perofrmance.

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This is Trump's FDA. Trump is on COVID's side. Remember, as Brad Delong likes to point out, the cossacks work for the tsar.

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I have a client in my semi-retired consulting business who is running 10,000 genetic tests per day on one shift for an animal genetics program. His machines can easily do testing for the Covid-19 virus and he contacted the FDA back in February. He would just have to make up primers for this virus, which is trivial for any lab doing DNA work.

Not being in the health care system, it would take 6 mo or so for approvals for Covid-19 testing. All his equipment and reagents were listed for "research and commercial purposes only"and not "approved" for medical (chemically the same stuff, just different labels and prices). His equipment and reagents are fine for publication in the top journals but aren't "blessed" by the FDA, which had no control over his lab design and operations and they had "concerns".

If you are running 10,000 tests per day and your bottom line depends upon those results being accurate, you are probably very good at it. Probably better than health care labs where bad results are still billed to the insurance company.

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