My understanding is that global public policy, and supply chains, and so on have nothing to do with the FDA’s official powers.
However, the whole thing is a dumpster fire, and the FDA technically has a legislative mandate to control the legal right to buy “water hoses”, which makes them the focal point during the dumpster fire.
In a deep sense, every person who dies because of a legally delayed treatment, or delayed testing, or very expensivemanufacturing that putting life saving medicine out of their reach… is dead because of the FDA.
...in the meantime the FDA is a bunch of doctors and biologists and statisticians who have the right to vote medicines “off the island”. NOTE: they have almost no economists.
(In theory, the FDA has a positive role covering the asses of doctors who can’t be bothered to read the primary literature themselves when pill pushers try to sell them on selling a new pill to random patients? If doctors actually were competent, we wouldn’t need an FDA. But if you think doctors are competent, why have an FDA? (But then again: if doctors are incompetent, the FDA can’t save you by itself. (None of it makes sense. No one smart can defend any of it that I’ve been able to find.)))
The FDA’s formal right is to veto “drugs” and “medical devices” and “biologics” by default. They just ignore a request for authorization, and until they act, the thing is illegal.
Then, if someone trying to bring a medicine to market gets pushy, they can be rejected explicitly by saying that a positive burden of proof has not been met, wherein they report enough evidence, described with enough paperwork, in studies pre-registered with the FDA, etc, etc, etc.
The official question is whether the medicine is “Safe(TM)” and also “Effective(TM)” but these concepts are totally bullshit.
They can Goodheart these concepts to mean anything they want them to mean in practice. All medicine is unsafe at the wrong dose, for example. If the placebo effect is real, then in some sense all placebos are kind of effective… But they don’t want to authorize placebos… That’s the opposite of the kind of monopoly maintenance they want to do… And so on.
People (including the CDC, or the President, or Medicare, or anyone) can ask the FDA to put their finger on the scale for any reason, including bad reasons as well as potentially good reasons. Also: any of them can leak stuff to the press to badmouth the others. So the president, unless he’s careful, is actually weaker than the FDA, because there ain’t no way to vote any of them out...
Assuming friendly collusion among them all… Maybe they want to keep a drug out of Medicare coverage, because it might extend lives somewhat AND is definitely very expensive? It could be better for government budgets if the poor people (the ones on Medicare) just died quickly and cheaply. So then maybe the FDA could do something to help with this budget problem by denying that drug? It might sorta work… so long as no one worries too much about too many details?
Practically though: studies that randomly give people medical insurance (who otherwise had none) just find that they go to the doctor more, not that they have any better net health outcomes.
So since most medicine is overpriced bullshit anyway, the primary importance of it for the last 50 years has been who gets privileged access to the big fact juicy profits. The FDA controls the money spigot. So the FDA are the cockiest people in the room that everyone sucks up to. Everyone praises them because everyone wants money.
...
The deep deep problem is that it is fine for the FDA to regulate “the efficacy and safety of boob implants” and similar private medical bullshit…
...but good old fashioned public health (like “plagues and other communicable diseases”) is NOT fake. Antibiotics are real. Vaccines are real. These things radically improved life expectancy in previous centuries! They are some of the only real medicine that exists. It is hard to extract the full value of the goodness from customers… how much is the patient’s life worth? How much of that can be charged for?
If monopoly power applies here, the clearing price might be something “just barely less than all the patient’s money to keep the patient from having to sell themselves into slavery” or some such? So the real medicine, in a system that extracts profits using scarcity pricing power, will bankrupt essentially all the patients :-(
So we have this system to facilitate and protect monopolies based on “soft private medical fraud” where all cause mortality might well GO UP after an Intent To Treat, and that just means you designed your study wrong, and should have measured some other “Efficacy” outcome so you could get in on the gravy train of profits in an acceptably legal and refined way...
...and this system being “fine” is predicated on the essential uselessness of medicine in general… and then along comes covid and finally we Actually Needed New And Real Medicine Very Fast… and we can’t do it anymore? Not via normal processes :-(
...
Personally, I think Biden should go after the the FDA, so that no one else with more odious characteristics does first. Biden’s best trait is “going off script towards decent common sense”. If Trump goes after the FDA in his campaign in 2024, god help me I will vote for Trump. I will vote for anyone at the federal level who agrees with “FDA delenda est”.
We can’t eradicate covid because we don’t have the tools. We need mass testing at scale in regionally isolated places that can be turned into “green zones” and then kept green by making every human who tries to go into a green zone go through a stop-and-test-and-incubate-and-test-again gate. Once two zones are both green, the gates between them can relax.
That’s how SARS Version 1 was eradicated… but back then a simple temperature check was adequate because it was not infectious at low doses… it was only infectious at the high doses that occurred during the peak of the symptoms. So then after SARS Version 2 was built in a lab (with serial passage in humanized mice to optimize the ACE receptor attachment) it became infectious even before symptoms, and so it needs more complex testing :-(
But lots and lots and lots of of super cheap testing (with near zero “false negatives”) is the key here to cleaning up the spilt milk I think...
So can a mayor clean up the spilt milk for his own city? No. There is no mayor in the US could save his city this way… because there are no FDA approved tools that hit the necessary points in terms of testing price and testing scale.
And no company is likely to spend millions up front securing (from the FDA) a monopoly for testing systems with the right characteristics. The government itself is their only market, and is unlikely to buy, and if it bought eradication-focused test kits the company that paid for all the research that the FDA voted on at the end… would face an oligopsonistic buyer with non-trivial negotiating power.
The whole thing is insane, and baroque, and only could exist in a world where no one with actual power actually cared about any of it in a competent way :-(
It has all the flexibility and efficiency of communism, and all the charity and civic-mindedness of capitalism.
Mayors and governors should be able to simply hire a scientist and a doctor and build a public health system.
The FDA should not be able to veto this, but right now it can, and right now it is, de facto, actually vetoing stuff like this.
I think we will eventually beat covid. That is no reason to keep the FDA. The FDA is structurally broken and will kill more people the next time medical innovation could save lives. That’s what the FDA’s job actually amounts to: preventing life saving that lacks the confused pointless (monopoly-maintaining) sacred approval of the FDA.
If doctors actually were competent, we wouldn’t need an FDA.
Seems wrong. Centralized approval means that we don’t need millions of doctors reading the same literature and duplicating work to determine whether something is safe.
I’d say that even if doctors are not competent we still don’t need an FDA that bans things, at most we need an FDA that evaluates strength of evidence for safety and efficacy and which competes with private firms doing the same.
I appreciate the response and I agree that it does “seem wrong” at first glance.
However, I think this appearnace is part of why the FDA is dangerous.
From what I can tell, the FDA is optimized to have a vaguely satisfying answer to every first order query that people raise “in general”. The problems show up in the second and third order analysis, and then the messed up practical details that actually arise after people stop questioning and start following bad laws.
The FDA actually DO NOT make things particularly easier for competent doctors.
The signal provided by the FDA is too noisy and confused and tentative for doctors to actually use to actually do their job properly just by relying on that and nothing more.
Example: the FDA has not approved melatonin for sleep. Melatonin is simply a supplement, like concentrated lime juice or St John’s Wort. I think lime juice is yummy and nutrious, I’m substantially more wary of St John’s Wort, and melatonin is one of my “staples” that I keep in my medicine cabinet for “just in case”. However, doctors treating the FDA as a source of “actual medical advice” miss all of this.
(The FDA’s essential power is the power to veto coercively. They do this by default for everything new, and then sometimes they loop back around and remove things from the market for various reasons which might sometimes be “because someone who the formerly legal drug competed with wanted the legal drug to no longer be able to compete with them so they lobbied for removal”. Once you’re able to buy or not-buy anything (drug, food, healthy food, spice, or whatever) the FDA’s input is done and over.)
The service you’re thinking that the FDA provides is actually provided by multiple groups, and the best one I know of (for everyone in general) is the Cochrane Review folks.
Cochrane provides an actual useful service. They try to break things down to the point of actionability, and review their reviews as more research comes in, sometimes changing the practical upshot, which the FDA basically never does.
Then separately there are often semi-large medical systems like Kaiser where they practice “evidence based medicine” where specifically their patients and their systems are subject to focused optimizing pressure of a similar sort. I’ve heard Kaiser doctors grouch about how they don’t enjoy their job as much when it feels like they are just following corporate treatment policies and not actually “practicing medicine”. Some doctors (who aren’t burned out yet?) seem to like unusual patients where they don’t have the EBM policies memorized, but maybe some doctors are happy to become “implementers of the policies of others” for the same handful of general practice problems, over and over and over.
But if you doubt doctor competence at anything but being a subservient lackey of wise bureacrats (which, maybe that’s valid, because maybe some doctors ARE burned out and phoning it in) then getting treatment from a corporate system like Kaiser can make a lot of sense, precisely because “the kind of service you’d naively expect from the FDA” is actually being offered by that corporate system’s best efforts towards generalized executive competence at science based medicine in an organizationally realistic way.
If there is a coherent positive argument for the FDA that round trips through the actual medical ecosystem… I’ve never heard it… and I’ve been looking for one since the FDA killed over half a million Americans just over 18 months ago.
The FDA has blood on their hands and I’m still can’t figure out why this isn’t common sense to the American voter, and also not even among particularly smart people!
Maybe I am missing something really obvious and big? The FDA has existed for longer than it has had legal support (it started out as a non-profit, basically, and then the government threw money and power at them during a crisis roughly a century ago) and so surely there are good and proper “Chesterton’s Fence” style reasons to support them out of common sense non-hubristic conservatism?
And I do love common sense non-hubristic conservatism.
Also, the train of thought seems somewhat binary. If doctors are somewhat competent, but the doctors who worked at the FDA were unusually competent, then having an FDA would still make sense.
My understanding is that global public policy, and supply chains, and so on have nothing to do with the FDA’s official powers.
However, the whole thing is a dumpster fire, and the FDA technically has a legislative mandate to control the legal right to buy “water hoses”, which makes them the focal point during the dumpster fire.
In a deep sense, every person who dies because of a legally delayed treatment, or delayed testing, or very expensive manufacturing that putting life saving medicine out of their reach… is dead because of the FDA.
Since the FDA itself is not safe or effective eventually we will repeal the Kefauver-Harris amendment (which authorizes the FDAs current existence). By the time this happens, some people (the ones able to experience shame?) who worked at the FDA will be hiding the fact that they worked there because it will be a mark of shame.
But in the meantime...
...in the meantime the FDA is a bunch of doctors and biologists and statisticians who have the right to vote medicines “off the island”. NOTE: they have almost no economists.
(In theory, the FDA has a positive role covering the asses of doctors who can’t be bothered to read the primary literature themselves when pill pushers try to sell them on selling a new pill to random patients? If doctors actually were competent, we wouldn’t need an FDA. But if you think doctors are competent, why have an FDA? (But then again: if doctors are incompetent, the FDA can’t save you by itself. (None of it makes sense. No one smart can defend any of it that I’ve been able to find.)))
The FDA’s formal right is to veto “drugs” and “medical devices” and “biologics” by default. They just ignore a request for authorization, and until they act, the thing is illegal.
Then, if someone trying to bring a medicine to market gets pushy, they can be rejected explicitly by saying that a positive burden of proof has not been met, wherein they report enough evidence, described with enough paperwork, in studies pre-registered with the FDA, etc, etc, etc.
The official question is whether the medicine is “Safe(TM)” and also “Effective(TM)” but these concepts are totally bullshit.
They can Goodheart these concepts to mean anything they want them to mean in practice. All medicine is unsafe at the wrong dose, for example. If the placebo effect is real, then in some sense all placebos are kind of effective… But they don’t want to authorize placebos… That’s the opposite of the kind of monopoly maintenance they want to do… And so on.
People (including the CDC, or the President, or Medicare, or anyone) can ask the FDA to put their finger on the scale for any reason, including bad reasons as well as potentially good reasons. Also: any of them can leak stuff to the press to badmouth the others. So the president, unless he’s careful, is actually weaker than the FDA, because there ain’t no way to vote any of them out...
Assuming friendly collusion among them all… Maybe they want to keep a drug out of Medicare coverage, because it might extend lives somewhat AND is definitely very expensive? It could be better for government budgets if the poor people (the ones on Medicare) just died quickly and cheaply. So then maybe the FDA could do something to help with this budget problem by denying that drug? It might sorta work… so long as no one worries too much about too many details?
Most medicine IS bullshit, and no one really cared for a long time. Robin Hanson was on about this for a long time in years gone by, but switched to other topics in the last ~5 years. No one cared.
Practically though: studies that randomly give people medical insurance (who otherwise had none) just find that they go to the doctor more, not that they have any better net health outcomes.
So since most medicine is overpriced bullshit anyway, the primary importance of it for the last 50 years has been who gets privileged access to the big fact juicy profits. The FDA controls the money spigot. So the FDA are the cockiest people in the room that everyone sucks up to. Everyone praises them because everyone wants money.
...
The deep deep problem is that it is fine for the FDA to regulate “the efficacy and safety of boob implants” and similar private medical bullshit…
...but good old fashioned public health (like “plagues and other communicable diseases”) is NOT fake. Antibiotics are real. Vaccines are real. These things radically improved life expectancy in previous centuries! They are some of the only real medicine that exists. It is hard to extract the full value of the goodness from customers… how much is the patient’s life worth? How much of that can be charged for?
If monopoly power applies here, the clearing price might be something “just barely less than all the patient’s money to keep the patient from having to sell themselves into slavery” or some such? So the real medicine, in a system that extracts profits using scarcity pricing power, will bankrupt essentially all the patients :-(
So we have this system to facilitate and protect monopolies based on “soft private medical fraud” where all cause mortality might well GO UP after an Intent To Treat, and that just means you designed your study wrong, and should have measured some other “Efficacy” outcome so you could get in on the gravy train of profits in an acceptably legal and refined way...
...and this system being “fine” is predicated on the essential uselessness of medicine in general… and then along comes covid and finally we Actually Needed New And Real Medicine Very Fast… and we can’t do it anymore? Not via normal processes :-(
...
Personally, I think Biden should go after the the FDA, so that no one else with more odious characteristics does first. Biden’s best trait is “going off script towards decent common sense”. If Trump goes after the FDA in his campaign in 2024, god help me I will vote for Trump. I will vote for anyone at the federal level who agrees with “FDA delenda est”.
We can’t eradicate covid because we don’t have the tools. We need mass testing at scale in regionally isolated places that can be turned into “green zones” and then kept green by making every human who tries to go into a green zone go through a stop-and-test-and-incubate-and-test-again gate. Once two zones are both green, the gates between them can relax.
That’s how SARS Version 1 was eradicated… but back then a simple temperature check was adequate because it was not infectious at low doses… it was only infectious at the high doses that occurred during the peak of the symptoms. So then after SARS Version 2 was built in a lab (with serial passage in humanized mice to optimize the ACE receptor attachment) it became infectious even before symptoms, and so it needs more complex testing :-(
(Biden should also go after Peter Daszak.)
But lots and lots and lots of of super cheap testing (with near zero “false negatives”) is the key here to cleaning up the spilt milk I think...
So can a mayor clean up the spilt milk for his own city? No. There is no mayor in the US could save his city this way… because there are no FDA approved tools that hit the necessary points in terms of testing price and testing scale.
And no company is likely to spend millions up front securing (from the FDA) a monopoly for testing systems with the right characteristics. The government itself is their only market, and is unlikely to buy, and if it bought eradication-focused test kits the company that paid for all the research that the FDA voted on at the end… would face an oligopsonistic buyer with non-trivial negotiating power.
The whole thing is insane, and baroque, and only could exist in a world where no one with actual power actually cared about any of it in a competent way :-(
It has all the flexibility and efficiency of communism, and all the charity and civic-mindedness of capitalism.
Mayors and governors should be able to simply hire a scientist and a doctor and build a public health system.
The FDA should not be able to veto this, but right now it can, and right now it is, de facto, actually vetoing stuff like this.
Hence: FDA delenda est. We must repeal the Kefauver-Harris amendment.
I think we will eventually beat covid. That is no reason to keep the FDA. The FDA is structurally broken and will kill more people the next time medical innovation could save lives. That’s what the FDA’s job actually amounts to: preventing life saving that lacks the confused pointless (monopoly-maintaining) sacred approval of the FDA.
Seems wrong. Centralized approval means that we don’t need millions of doctors reading the same literature and duplicating work to determine whether something is safe.
I’d say that even if doctors are not competent we still don’t need an FDA that bans things, at most we need an FDA that evaluates strength of evidence for safety and efficacy and which competes with private firms doing the same.
I appreciate the response and I agree that it does “seem wrong” at first glance.
However, I think this appearnace is part of why the FDA is dangerous.
From what I can tell, the FDA is optimized to have a vaguely satisfying answer to every first order query that people raise “in general”. The problems show up in the second and third order analysis, and then the messed up practical details that actually arise after people stop questioning and start following bad laws.
The FDA actually DO NOT make things particularly easier for competent doctors.
The signal provided by the FDA is too noisy and confused and tentative for doctors to actually use to actually do their job properly just by relying on that and nothing more.
Example: the FDA has not approved melatonin for sleep. Melatonin is simply a supplement, like concentrated lime juice or St John’s Wort. I think lime juice is yummy and nutrious, I’m substantially more wary of St John’s Wort, and melatonin is one of my “staples” that I keep in my medicine cabinet for “just in case”. However, doctors treating the FDA as a source of “actual medical advice” miss all of this.
(The FDA’s essential power is the power to veto coercively. They do this by default for everything new, and then sometimes they loop back around and remove things from the market for various reasons which might sometimes be “because someone who the formerly legal drug competed with wanted the legal drug to no longer be able to compete with them so they lobbied for removal”. Once you’re able to buy or not-buy anything (drug, food, healthy food, spice, or whatever) the FDA’s input is done and over.)
The service you’re thinking that the FDA provides is actually provided by multiple groups, and the best one I know of (for everyone in general) is the Cochrane Review folks.
Cochrane provides an actual useful service. They try to break things down to the point of actionability, and review their reviews as more research comes in, sometimes changing the practical upshot, which the FDA basically never does.
Returning to the example: For melatonin, Cochrane is in favor of it for jet lag but unconvinced for use in ICUs even after hearing the pitch in favor, and looking at studies.
Then separately there are often semi-large medical systems like Kaiser where they practice “evidence based medicine” where specifically their patients and their systems are subject to focused optimizing pressure of a similar sort. I’ve heard Kaiser doctors grouch about how they don’t enjoy their job as much when it feels like they are just following corporate treatment policies and not actually “practicing medicine”. Some doctors (who aren’t burned out yet?) seem to like unusual patients where they don’t have the EBM policies memorized, but maybe some doctors are happy to become “implementers of the policies of others” for the same handful of general practice problems, over and over and over.
But if you doubt doctor competence at anything but being a subservient lackey of wise bureacrats (which, maybe that’s valid, because maybe some doctors ARE burned out and phoning it in) then getting treatment from a corporate system like Kaiser can make a lot of sense, precisely because “the kind of service you’d naively expect from the FDA” is actually being offered by that corporate system’s best efforts towards generalized executive competence at science based medicine in an organizationally realistic way.
If there is a coherent positive argument for the FDA that round trips through the actual medical ecosystem… I’ve never heard it… and I’ve been looking for one since the FDA killed over half a million Americans just over 18 months ago.
The FDA has blood on their hands and I’m still can’t figure out why this isn’t common sense to the American voter, and also not even among particularly smart people!
Maybe I am missing something really obvious and big? The FDA has existed for longer than it has had legal support (it started out as a non-profit, basically, and then the government threw money and power at them during a crisis roughly a century ago) and so surely there are good and proper “Chesterton’s Fence” style reasons to support them out of common sense non-hubristic conservatism?
And I do love common sense non-hubristic conservatism.
But at some point the weight of logic, evidence, and sanity has to pile up such that you fix the giant obvious death machine in your midst? Right? Eventually?
Also, the train of thought seems somewhat binary. If doctors are somewhat competent, but the doctors who worked at the FDA were unusually competent, then having an FDA would still make sense.