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“What would a practical abolish-the-FDA-lite policy proposal look like?”

The lazy answer is, just leave it as it is, but advisory rather than mandatory. Just let innovations happen on the margin.

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Can you expand more on what "advisory rather than mandatory" would look like? Companies would be allowed to seek an FDA seal of approval, but wouldn't have to?

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Basically, yes. Obviously I have not given it much thought, so I can’t fill it in. But that is my go-to attitude for reform, don’t make people who are happy already into unwilling experimental subjects, just let the willing subjects give it a try.

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I haven't put too much thought into it either, but the view I have seen most often is not 'abolish the FDA'. Rather, it is to make it opt-out. Which I think is DavesNotHere's idea as well.

Require a big red sticker that says 'NOT FDA APPROVED' on any drug choosing to opt out of FDA guidelines. Companies are still liable for torts, as always. One way to discharge your duty is to demonstrate that your drug was FDA-approved. But even currently, that is not sufficient, though it is necessary. Under this proposal, it would be neither necessary nor sufficient.

In the immediate aftermath, things don't look too different. However, an entrepreneur realizes that there is a an opportunity to be had-- start a company that gives a 'gold-seal' of approval that, like the FDA, offers a presumptive case against negligence. Essentially, have a competing FDA.

There is the issue of judgment proof start-ups looking to cut corners, but mandating liability insurance would solve this. The insurance company, not wanting to be on the hook for millions of dollars in damages, would require the company to follow certain regulations. But only insofar as the regulation is efficient. As an aside, this is a libertarian response to most of these kinds of regulations (echoed by Dave)-- if it really is efficient, just mandate insurance, and the insurance company will require the regulations.

There is more to be said, obviously. But I think this kind of proposal makes a lot more sense than the 'abolish the FDA' proposal, for many of the reasons you discussed. Functionally, it is pretty much just a dressed-up version of your legalize synthetics as supplements line of thinking.

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So if I make sure all my assets are offshore and held in a jurisdiction that doesn't recognize US court judgments?

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That’s the sort of thing that would make your Gold Seal of Approval not carry much weight.

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Right. Also, something that would make it harder to find insurance companies willing to take on potential liabilities. Of course, Feral might counter with 'what if the insurance company hides their assets and goes bankrupt'. Now, my understanding is that there is federal/state regulation to prevent that sort of thing, but since we are making the libertarian case that would seem like a cop out answer.

A better reply might be that if people are worried about such an issue, then it would be in the interest of an entrepreneurial company (perhaps the same as the FDA competitor, perhaps different) to offer a second seal of approval; namely, that the company has adequate insurance with a company that can pay its debts.

So, one seal vouches for the quality of the product. Another vouches that the company has insurance willing to cover its ass. If consumers value the assurance that a company who will bear the cost of liabilities (the insurance agency) has agreed to indemnify the company, they will opt for that product. Others may take the risk, and opt for the 'insurance-free' bargain.

The likely counterargument is that consumers do not have enough knowledge and sophistication to meaningfully understand the distinction between a drug that carries a seal of insurance and one that doesn't. But you can carry on arguing forever here (eg. grocery stores/pharmacies might, and might not want to sell risky drugs to consumers.. etc.).

Again, not an expert in this-- just my initial thoughts. Happy for better replies/counters.

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So the public are supposed to be lawyers as well as scientific reviewers.

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that's something I don't get about law because if I buy chemical X and it poisons me, why is that the seller's problem? Or if you want to have a default deal that's fine, but why should I not be allowed to buy X with the only promise given that it is X.

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If I understand your comment correctly-- you are asking why the presumption shouldn't be 'buyer beware'. I think the reply is that given that currently, most consumers operate on the assumption that a drug is FDA-approved, it would be negligent (perhaps fraudulent) for a company to sell a drug, without explicitly noting that they are not in FDA compliance.

If what you are asking is why it is the seller's problem that they sold something that poisoned you (and not your own problem)-- the answer to that encompasses tort law. There are separate justifications for why we have tort law, that libertarians may or may not agree with-- but that would be a longer explanation that I feel unqualified to offer.

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So from what I've seen, the whole problem with this line of thinking is enshittification.

Companies have repeatedly shown that they are willing to build up a good reputation in phase 1, and then take a treacherous turn in phase 2 to cash in that reputation for money at the expense of the customers that got used to trusting them.

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There are third parties like LabDoor which do this for some supplements. The companies then advertise this in their marketing.

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From the post:

> The only problem is that this hasn’t happened with supplements (examine.com, LabDoor, etc, are nowhere close to this level, sorry

so I assume Scott wants something better / something else? Idk.

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I've never found an evaluation of how good LabDoor is.

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AFAIK this is almost exactly the role Underwriters Laboratories plays in the electronics industry.

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UL and UL certification are the exact model I think of w/r/t changing the FDA.

I'll expand down below, but the ideal would be to allow the FDA to carry out its mandate -- generally checking that most things US citizens might *ingest* aren't useless, tainted, or wildly dangerous -- without having de facto total control over the drug industry and huge amounts of government healthcare spending.

(Government healthcare spending being actually ALL healthcare spending, at this point, another thing that Must Change)

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Dec 7, 2023·edited Dec 7, 2023

How much does it cost to comply with UL certification? What percentage of devices submitted for certification end up being denied?

One of the problems with FDA drug trials is that (apparently) they end up costing in the hundreds of millions of dollars to run, with many of them not successful.

I suspect that UL certification tends to be less of a crap shoot.

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This is because we understand electrical engineering far more deeply and reliably than we do pharmacology. It's not a feature of UL vs FDA, it's a feature of their respective domains. When a drug fails its FDA drug trial, it's usually because it's useless.

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Which is an argument that taking UL certification as a model for drug licensing is premature. We would need to know a lot more before we can do that.

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Speaking honestly, we could probably keep the majority of the apparatus that confirms that some food or drug won't actively kill people. In the pharma world, that's the goal of Phase 0/1 clinical trials, which are notably inexpensive relative to phase 2 (roughly speaking: prove it could work) and phase 3 (prove it works a lot). The result would be a market for drugs that won't hurt you, might not do anything at all for your joint pain, but it only costs you $7 to find out.

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I'm an FDA skeptic: https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/ and there are others: https://marginalrevolution.com/marginalrevolution/2023/12/dont-let-the-fda-regulate-lab-tests.html. But I've never argued for abolishing the FDA, for the reasons you cite. Or, if it were abolished, it'd need to be replaced by *something* to regulate drugs.

Since I've got fatal cancer, I'm particularly interested in that area, and a lot of the emails and comments I've seen have two major complaint components: 1. the FDA is too slow and 2. the FDA is too random. The slowness part entails submitting study plans or data, which the FDA takes months and months to process even though statistical analyses can be done almost immediately via Excel or SciPy or R or whatever.

The randomness part is the failure for the FDA to set and keep to clear guidelines about what constitutes a reasonable trial, what success looks like, and what failure looks like. This raises the cost of compliance and, again, can waste months or years of time. Even in a low-interest-rate environment, that's terrible. In a high-interest-rate one, it's even worse. Meanwhile, people die for lack of treatments.

We saw both pathologies at work during the pandemic.

If a federal drug regulator acts too fast, some people may be hurt or die from bad treatments. But if one acts too slow, some people may be hurt or die from lack of good treatments. There's a scale between them, and right now the FDA is way too far towards the second, and it needs to move towards the first. Governments and government agencies, though, very rarely give up power once they acquire it.

Imagine trying to run a business, but first you have to run a gauntlet of opaque government agencies that take months to years to reply to submissions. That situation would kill many startups and businesses. I realize I'm describing San Francisco, but most startups are Delaware C Corps, which avoids many of SF's pathologies in ways retail can't. In most of the U.S., it only takes ~4.2 days to start a business: https://tradingeconomics.com/united-states/time-required-to-start-a-business-days-wb-data.html.

And then there is the clinical-trial quagmire: https://bessstillman.substack.com/p/please-be-dying-but-not-too-quickly, which has emerged as it has in part from the two FDA pathologies noted above.

So there's a lot that can and should be done better, though a total free-for-all is also undesirable.

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In thinking about this more, I think one problem is that the FDA does so many different things that are somewhat related but not really the same—like regulating ADHD meds versus oncology treatments—that it's hard to fully accept "FDA good" or "FDA bad." It's too different. Maybe breaking the agency into smaller pieces would make sense.

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Most likely, breaking the agency into several pieces results in a world where you need to get the approval of several different agencies to do anything, rather than just one.

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Where does our host come out on this question?

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I think as a general rule, a major government reform I would like would be to restructure so that you never need permission from more than one body to do something (granted, this is hard to implement)

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Yeah, probably. It would seem to make sense to break off, say, the part responsible for "visit the plants and make sure they're not putting melamine in the baby formula" and let them just do that kind of job.

But then you'd probably end up with a whole new agency, with accompanying bureaucracy, for "Going Round To Chemical and Pharma Plants To Make Sure They're Not Putting Shit In Stuff", plus an agency turf war over does this include food production plants or not under their aegis, or shove off new agency this is our bailiwick and always has been?

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Yes, rather like Homeland Security. You had a security problem, people fought over whos fault it was, the result was adding another bureaucracy on top of all the existing ones.

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I don't think there is one simple answer, or any answer that will satisfy everybody.

Look at the Covid vaccines: opinions went from "skip all the red tape paperwork, this is a crisis and we need them now with minimal approval roadblocks in the way!" and then afterwards "these vaccines are killing healthy young adults, why were they rushed out, where were the approval roadblocks?"

A lot of the problem is reacting to crises. Food and Drug acts were passed in many countries because manufacturers were putting any old shit into products and poisoning the public. As "this drug caused A, B, or C serious side effects" cases came along, and went to court, so the red tape and regulation got cranked up every time.

Now there is (and I think we should err on the side of caution) the cautious approach about "let's dot every i and cross every t" before approving new drugs. But that holds up promising new treatments. But how can you tell "promising in the early stages but useless when given as a medication" from "promising in the early stages, effective when given as a medication" without large scale testing? And that means delays.

I don't know. There probably is a lot of room for improvement, but what part can you safely prune away and what part is going to be load-bearing?

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The "afterwards" set of opinions was exclusively held by idiots who should be ignored.

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That may be, but we really did see a divergence (i.e. I saw it between members of my family) over the vaccines between person A saying "the FDA is killing people with red tape, how could they possibly be taking so long to approve these vaccines" and person B saying "this is the fastest FDA vaccine approval ever? In an environment where the person A mindset is publicly pressuring them to approve it even faster? No WAY they're not cutting corners; we can't know if these are safe"

Which is to say there are always tradeoffs and the FDA legitimately could have reduced vaccine hesitancy by taking longer to approve the shots

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> FDA legitimately could have reduced vaccine hesitancy by taking longer to approve the shots

I don't think that would have helped. Most of the public didn't have the faintest idea how long it takes to produce a new vaccine -- whether it's 6 weeks, 6 months, or 6 years --, and what the different methods of producing one are. The problem was that the media kept yapping about how fast it had been produced, and the novelty of the method -- well, they had to write something to capture eyeballs, and of course for some people it was *good* news that some wonderfully smart people had used this novel method and produced an effective vaccine so fast. But that info was seized on by people who were already angry and mistrustful because of how covid had been handled so far, accurately perceiving that the government was herding us rather than informing us of the best direction to wallk in. And then of course social media amplified the fear, anger and mistrust.

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I've asked a few people about what they thought about this. I think many people were nervous about the vaccines because of how quickly they'd been produced - and arrived at this idea independently of press coverage, and would probably have found it eerie if nobody acknowledged that they were brought to market much more quickly than a lot of other vaccines. My sense is that this is because most people don't realize how straightforward vaccines are (the body does the heavy lifting, really, all you need to do is present an antigen) and so they assume it must be a long and complex process fraught with difficulty (perhaps exacerbated by how much people worship the pioneers of immunization like Pasteur and whoever and act like they're geniuses of unimaginable and superhuman magnitude).

People don't realize that one-in-ten-thousand safety risks don't really happen with vaccines (not to mention the obvious safety risks of not getting a covid shot, which many people don't really think about, because of some sort of cognitive bias I don't really understand), regardless of how quickly they're brought to market, but I think, in the absence of any information either way, people would assume that one-in-ten-thousand safety risks are actually a common pitfall, just because of how difficult I think people assume vaccine development is. (Yes, I know about vaccine-mediated enhancement, but that doesn't really have any bearing on this because it was conclusively rules out by clinical trials.)

(Another reason people might assume it's fraught is that development of small-molecule pharmaceuticals is definitely very fraught, and I think a lot of people don't understand the huge difference between vaccines and small-molecule drugs.)

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Dec 7, 2023·edited Dec 7, 2023

>many people were nervous about the vaccines because of how quickly they'd been produced - and arrived at this idea independently of press coverage, and would probably have found it eerie if nobody acknowledged that they were brought to market much more quickly than a lot of other vaccines.

But it's not as though new vaccines are brought to market often, right?, which would give people a sense of what typical pace for developing them is. I think the only vaccine development process most people are aware of is the flu vaccine, which is different every year. Actually, of course, pharmaceutical companies don't build a whole new flu vax in a whole new way every year -- they just tweak the formula. But how much of the public knows that?

And in any case: People you know are saying they would have been worried without the media's yammering about the novel technique and rapid development of the covid vax? How can they know that? It was utterly impossible not to be exposed to a shit-ton of info, speculation and opinion about mRNA vaxes and the speed of development, unless one was a hermit. How can any of us know how we would have felt about various developments in the covid saga if we had had no input from the news media and the goddam social media?

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Dec 6, 2023·edited Dec 6, 2023

The answer, of course, is "most vaccines take years to approve because raising money for the trials takes ages; the trials themselves are pretty quick. This is what it looks like when we don't dawdle."

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But if you don't trust it when it's first approved, you can wait half a year more until millions of less skeptical people have got it (perhaps until it has full, not emergency, approval), and there is much more data than there would be from half a year more of clinical trials. I don't have high confidence that this actually convinced many people, but I also don't think a slower but still fast by ordinary standards approval would have convinced many people.

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But of course by the time half a year had passed Twitter and no doubt other sites were full of stories about people developing grotesque symptoms and severe illnesses and flat-out dropping dead right after receiving the vax. I was on medical Twitter all through covid, following epidemiologists, immunologists, researchers, etc. and saw literally hundreds of these stories in comments made in response to posts about research by smart, honest professionals who were working their asses off to understand covid better. Over time the tone of stories changed from alarmed to snarky: "Sure, asshole researcher, promote the vax. We've figured out what's really going on."

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Sure, but if you wait half a year longer to approve it, those scaremongering stories would have still appeared by the time half the population has got it. Except perhaps if they manufacture enough doses for everyone before approving it, and then they gave out the shots very quickly, before anyone has a chance to put out those stories. And doing that would give up a genuine safety benefit of having data from millions of people by the time less vulnerable people who benefited less from the vaccine got it, and it would generate another form of skepticism in the form of "why do they insist we take it immediately?".

And then there is that the benefit of less vaccine skepticism would have been far outweighed by the harm of later access for less skeptical people. And that the former benefit would have primarily accrued to people making poor decisions, while the latter harm would have accrued to people making good decisions.

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There's no rigorous psychological evidence that reduces vaccine hesitancy, and instead when the FDA engaged in amateur psych to pause the J&J they INCREASED hesitancy.

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Different people have different levels of risk tolerance and even different understandings of what risk looks like. While I think some of the anti-vax opinions related to COVID were outright mistakes rather than just value disagreements, I think a good solution would include a system that allows people to take on risk if they do so with informed consent. The devil is in the details. But in theory there's room enough in this world for the ravers and the anti-drug folk and everything in between.

More narrowly: If a drug is approved in another OECD country it should be available with warnings and outside of a standard of care in the US. If people want to pay for it, they should be able to purchase it. Or someone should make an argument that the approval process for that country is significantly worse than the one for the US.

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In the current system, the FDA micromanages product testing conducted by other entities - usually the manufacturer. If the manufacturer doesn't comply with extremely detailed testing parameters that are only conveyed in secret closed-door meetings then there are delays and people are forbidden to choose potentially life-saving medicines. There's no independent peer review mechanism for the question of whether the FDA's demands are reasonable - and that's important because, from my perspective, the FDA appears to frequently be falling into the type of dangerous sit-tight-and-assess behavior parodied in Don't Look Up.

It might help to drill down on a specific example. Based on published data, I would bet that a Covid vaccine called SKYCovione could offer me broader, more durable protection than first-generation Covid vaccines. Here's more detail:

https://cbuck.substack.com/p/extraordinary-evidence-requires-extraordinary

SKYCovione was approved in South Korea a year and a half ago, but FDA continues to judge the overseas data as inadequate to support approval. I can read the overseas data for myself and I think the FDA is wrong - to the point that I've literally considered flying to South Korea as a refugee vaccine tourist. FDA vaccine committees seem to me to be trapped in a bureaucratic cover-your-ass funhouse on this question. The myopia could realistically have something to do with the fact that vaccine manufacturers are paying their salaries:

https://www.nytimes.com/2022/09/15/health/fda-drug-industry-fees.html

And the decision-making process could be distorted by the fact that manufacturers are allowed to offer FDA employees top 0.1% salaries on the other side of the revolving door:

https://www.hulu.com/series/dopesick-227de06a-d3d4-42e0-9df1-bb5495e1738d

The fundamental problem is that there are no checks and balances in the current system - FDA veto authority is inscrutable, unaccountable, and unbreachable.

In a separate comment I sandbox the idea that creation of competitive independent testing agencies could, in the longer run, make it possible to abolish the FDA. Independent testing works fine for dangerous products like cars - so why not for medicine? Figuring out how best to organize independent testing infrastructure is an interesting debate. What I don't understand is why any American on either side of the aisle would think that having a government agency with unchecked veto authority is a great idea. It's obviously an abomination. We should abolish the FDA's unchecked veto authority as soon as possible.

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"… and get it all exactly right." Yeah, that's kinda true, but it's not *tricky* to "reform" them all to the ground (salt to taste).

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I think Scott is saying "the FDA needs to be reformed, not abolished" without getting dogpiled by libertarian reply guys

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Minor warning for low information, high temperature comment. 25% of a ban.

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I'm sorry. It wasn't meant as a criticism at all.

Your piece points out a number of reasons why the libertarian approach seems unworkable, and notes that if there is a way to make it work, it hasn't been discovered yet. I read that as your not supporting abolition until the solution is discovered, which is the kind of position that (if stated explicitly) tends to get a lot of rude responses.

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I wasn't saying you were criticizing me, I do think "dogpiled by libertarian reply guys" is an unfair way to put it.

I can see arguments for rip-off-the-bandaid type solutions but that's not my style.

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I'm not unsympathetic to libertarian policy options but LRGs are definitely a common type of RG, though maybe not on your substack since the things you write wouldn't normally wind them up.

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Not a direct response, but do you associate "RG" with "low-information high-temperature responder"? I'm not sure this is actually true (and kinda dislike the stereotype, mostly because I find it easier to respond to things than proactively write them).

There's definitely a thing where if you look at a random insightful post most replies will be low-quality, but that's just because most content is low-quality and it being in response to an insightful post doesn't counteract that much. I don't think replies are inherently lower-quality in general though (though there is a good argument that it's harder to filter them for insightful ones).

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Yeah. Writing a reply doesn't necessarily make you a reply person.

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This is me. My ratio of replies to posts is definitely greater than 10. I strive to reply in a manner that is interesting or useful so do find the pejorative use of RG a little unfortunate. Part of it is status I guess and part of it is simply that a lot of replies are genuinely low to no value. Maybe we need a new term for us RGs to aspire to: the high value reply guy (HVRG). Hehe.

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I think you seem to be failing to grasp that Scott does not want you to cavalierly dismiss people on the other side of the argument as “reply guys,” which is rather anti-intellectual and unnecessarily inflammatory.

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I hope I wasn't being cavalier. But Scott's argument felt like something that a sensible progressive could have written in peak 2020: "Here are a few issues we need to resolve before we move forward on abolishing the police", followed by a laundry list of reasons the whole approach is misconceived.

In other words, it seemed like a reasonable argument that was carefully phrased to reach people whose views on a given issue aren't entirely reasonable, without triggering a dismissive "reply guy" reaction from them.

There's a need for that style of argument. If I'd been assigned to write a piece on this topic it would have been much shorter than Scott's and the tone would have been "what a dumb idea", which wouldn't have been helpful in changing anyone's minds. Scott is more libertarian than I am and that (plus his medical degree) gives him credibility in explaining to FDA abolitionists that this is, in fact, not a well-thought-out proposal.

I thought he managed that in a very tactful way and by pointing out that this seemed to be what he was trying to do, it may have looked as if I was trying to spoil his rhetorical strategy. But I hadn't meant to imply that people with ill-considered opinions are stupid, only that it helps to address them with respect.

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I think rip-off-the-bandaid solutions will produce chaos, which the well-off and well-educated will be able to navigate with decent success. Everyone else will suffer greatly.

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FWIW, I don't think anyone would be able to navigate that successfully...or at least not safely. Scot points out a number of things that would need to be addressed. If they weren't...I doubt that even caffeine tablets would be safe. And he left out a bunch of things that currently really need more effective regulation. (Meat packing plants are currently a lot better than they once were, but they're hardly very sanitary.) The problem is, with the current setup, being sanitary, safe, etc. isn't sufficient. You also need inspection seal which can be both expensive, and require a bunch of stuff that's irrelevant for what you're doing.

I don't see any good solution, only modest improvements. And a lot of the improvements are disallowed by bureaucratic regulations which either don't reasonably apply (in some situations), or were always for the purpose of empire building. But there's no clear way to disentangle the necessary from the extraneous.

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Well, the FDA isn't the only drug-regulating agency on the planet. In principle, educated people could just choose to rely on e.g. European regulators for judgments of safety and efficacy, and Canadian and Mexican authorities for quality/contamination control.

(This is more-or-less what a lot of smaller countries do as a matter of policy.)

It's still a really terrible idea, but it's not necessarily catastrophic for *everyone.*

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Would be nice to have some high quality, RCTs looking at the aggregate effects of healthcare utilisation accross various margins, expensive but could potentially save a lot of resources. Also would be nice if politically more emphasis was on the more robust correlates of health such as diet, exercise, pollution, stress etc.

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Most abolish the FDA types are proposing a grand remaking of the relationship between government and citizens. Courts, insurance, medical licensing and welfare would all be changed so much it doesn’t make sense to speculate on the effects of FDA disbandment on present institutions.

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This is very similar to what I’ve been told about abolishing police or prisons: we’re talking about totally transforming society so there’s no point trying to figure out how it would work.

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I really don't understand who finds this argument pursuasive - surely the bigger the change, the more important it is to think it through first!

I don't think "don't worry, this change will be radical so don't worry about the details of it" is pursuasive in any practical context - If I was on a plane to New York and the pilot told me our flight was being redirected to Boston, I might have a few questions but I'm sure it would work out in the end, but if I was told our flight was being redirected to Havanna I would have a lot more questions about the practical implications of our change of course.

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Yes, I agree, and it also seems like an acknowledgment by the speaker that they are not talking about changes they ever expect to happen. It’s Land of Cockaigne stuff.

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Scott has had some hard words for arguments of this form in the past: https://slatestarcodex.com/2014/09/13/book-review-singer-on-marx/

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This way of thinking comes from Hegelians, who are the cause of all America's present political woes. Hegel argued that there is a World Spirit guiding humanity on a path towards ultimate perfection. At each step on this path, the World Spirit chooses one nation to move humanity forward to the next level. If you are one of the Chosen People, all you must do is destroy your current society, and the World Spirit will see to it that the next, more-perfect iteration of human society springs up from the ashes.

This is stupid, and few if any people believe it consciously. Yet it is/was obviously assumed by Marxists, the early modern artists, the leftists of the 1960s, and many leftists today. I think most leftists today would justify this by saying that humanity is naturally kind and cooperative, and any instances of suffering are necessarily caused by evil people who have gotten into power. Destroy the system, and "the people" will be in power, and everyone knows the people are good.

You could also attribute this to Rousseau, who taught that the natural state of humanity is idyllic, and civilization is corrupting. It ultimately traces back to Plato, who taught that the world began with the perfect Forms, and that over time, things can only degrade, as copies of copies of copies, unless they are destroyed and remade in the image of the original Form by a philosopher who has insight into the Forms.

The first step toward wisdom in this matter was by Adam Smith in 1776, the first person AFAIK who realized that the question that needed an answer is not why some people are poor and miserable, but why some people are not.

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I don't think that's true. Many people who want to abolish the FDA may also want to abolish other government agencies, but their support for abolishing the FDA is in no way contingent on other reforms. I think Scott is overselling necessary changes. You could easily abolish the FDA and everything would continue exactly as before except insurers would have to find a new basis for what new treatments to cover (and doctors for what new treatments to prescribe). Anyway many proposals are for FDA approval to be optional or to revert to safety review only (not effectiveness).

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One, libertarians are just as much a monolithic creed as are Substackers, YouTubers or TikTokkers. Two, agreed that the FDA is one of the wonders of the modern world, barely a whisker below the NHS. They admitted once that they'd made a mistake but turns out they were wrong.

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"Agreed"? I think the FDA is terrible, it's just dug itself into the system so deep that it's hard to get rid of it.

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Then why are you defending it so hard?

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So, what’s your plan?

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Fine-tuning a steampunk balloon wouldn't have got it to the moon. But Americans love one-hundred thousand page legislative documents. They provide work not only for the drafters but for millions of bureaucrats, and cavernous warehouses for pork. Yes I am aware of Chesterton's Fence. Ask why the fence is there before you tear it down. Finland for example probably has a platoon of one or possibly two thousand accomplishing the same as or better than the armies of the FDA. Elon Musk has built a fine if fugly truck by throwing away everything that doesn't absolutely essentially have to be there. It outperforms Porsches and Lamborghinis.

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What?

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What what?

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Elon built a truck that people who drive trucks are unlikely to buy, because it misses the point of a truck. It's not easy to repair or modify, it is likely to struggle in rural areas, it has no way to fit plows, dump bodies or PTO driven accessories. Etc etc.

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Scott gives his reasons for the writing the post in the first two paragraphs.

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I think Hypatia is saying that both the FDA and NHS are not only terrible, but so terrible that they cause awe and wonder in all who behold them.

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Yes, as one would feel viewing a cathedral made entirely of petrified dinosaur shit.

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The NHS saved my partner's life, so I have a somewhat rosier view of it (and indeed object to it being not only compared to the FDA, but compared *unfavourably*).

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Saved your partner's life contra some world without the NHS?

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I mean, probably any first-world healthcare system would have been able to do the same (though some would have tried to stick us with an enormous bill for several days of inpatient care). But the NHS was the one that actually did it.

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FWIW, and as someone who is not a health professional, I think the FDA is marvelous. It's got a number of places where it needs to be improved, but it's an organization managed by teams of humans, and it's still trying to do it's job more than increase its power. And the job that it's trying to do is an extremely important one.

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As David Friedman said, ""There may be two libertarians somewhere who agree with each other about everything, but I am not one of them."

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The current movie "Pain Hustlers" on Netflix with Emily Blunt and Chris Evans as fentanyl lollipop marketers is instructive:

https://www.youtube.com/watch?v=HbPeXsdamT4

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I don't think legal fentanyl has been that much of a problem. Matt Yglesias has a point that the scientific discovery of fentanyl wreaked disaster once drug-dealers realized they could make their products more potent by cutting it with cheap fentanyl, but that's a different topic.

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What lesson do you draw from it?

The trailer emphasizes money. They were able to get a lot of money because insurance companies were paying for this treatment. If this were out of pocket, there would be no movie. The Purdue problem was that the standard (which was probably not explicit and certainly wasn't created just by the FDA) was that oxycodone was bad and anything new was good. This sounds like the same problem, but it was after Purdue! Was this about bribing FDA and DEA?

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Surprised you haven't mentioned a common proposal: autoapprove anything the European Medicines Agency approves. This could replace, or be added to, current FDA approval processes. We can keep the FDA around for enforcement (e.g. factory inspections), or create a new body that only does this.

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This would have instantly solved the great formula shortage of 2022. But I did get a bit of a high from smuggling in a dozen boxes of Canadian formula in the trunk without the CBP noticing.

(Fun fact: the "Canadian" formula was actually made in the USA. Apparently bilingual labels aren't FDA-approved.)

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This would also have avoided the absolute scandal of millions of doses of AstraZeneca Covid vaccine sitting in warehouses for months while the FDA insisted on duplicating the trials that had already been done, but this time in America.

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FDA ended up never approving AstraZeneca, right? I think they did end up shipping those doses to other countries that approved them, but it seems like such a shame that it was never approved here (and that Novavax approval was held up so long that most people never even heard it was approved).

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Looks like the FDA approved it for travel purposes only: https://en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations#Oxford%E2%80%93AstraZeneca I'm glad to hear that those doses did eventually get used (and even more pleased to see that AZ is the most widely-administered vaccine worldwide: not surprising, since it used well-established tech and was designed to be manufactured cheaply and at enormous scale). But it's still infuriating that those doses weren't released earlier when they could have done much more good.

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The AZ vaccine was not well-established tech. The only prior approved vector vaccine was an ebola vaccine with emergency approval in 2015 and full in 2019. The total number of vector vaccines administered before the AZ trial was probably 1/10 as many as in the trial.

Everyone agrees that vector vaccines are (for now) easier than nanolipids, but they aren't that easy. While Russia and China were able to make their own, they weren't able to produce enough to matter. So India, which produced most of the doses, probably really needed the help of AZ.

The small mystery is why the West didn't just print protein vaccines. A rogue German distributed 20k doses, so it probably would have been even easier. The answer about the West is probably corruption. The big mystery is why China and Russia didn't use 20th century technology, but went back to 19th century vaccines.

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> The only prior approved vector vaccine was an ebola vaccine with emergency approval in 2015 and full in 2019.

Huh, OK. Wikipedia gives examples going back to 1972: I guess none of those were approved for use in humans?

> The small mystery is why the West didn't just print protein vaccines.

Looking at https://en.wikipedia.org/wiki/COVID-19_vaccine#List_of_authorized_vaccines, the first "subunit" vaccine to be approved (that's the same thing, right?) was China's Zifivax, in March 2021. I remember there being several protein subunit vaccines under development in 2020, so I guess either they didn't pan out or took longer to get to market for some reason?

> The answer about the West is probably corruption.

Could you expand on this?

> The big mystery is why China and Russia didn't use 20th century technology, but went back to 19th century vaccines.

I see both Chinese and Russian subunit vaccines on the list, but all debuting after their respective inactivated-virus vaccines.

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Ah yes, moving towards one worldwide government. I don't think the anti-FDA folks would support that.

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I'm anti-world government because I don't want a single authority being able to restrict everyone's freedom. The FDA shouldn't exist, so multiplying the number of agencies sufficient to approve gets us closer to that ideal.

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It's not one worldwide government. It's just saying that if the German government (or a small group of other trusted countries) approves a drug, American doctors should be allowed to prescribe it.

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This isn't politically viable. If it happened, no clinical research would ever be done in the USA, which is probably hundreds of billions of dollars a year. Any industry that large will fight back politically, and they'll fight back hard.

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So the FDA process is nothing more than crony capitalism, like farm subsidies or public funding for sports stadiums?

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I was not the one who made the claim that the just because an industry heavily relies on the presence of a regulatory infrastructure this necessarily implies the entire industry is "nothing more" than a rent-seeking apparatus.

I merely pointed out that there would be significant unintended consequences of attempting to shift approval reliance from US regulatory authorities onto OUS authorities - one of which being the alignment of lots of interest groups in keeping clinical research in the USA. As someone who works in clinical research (and had an FDA interaction this week, actually) I agree that the current system needs a LOT of work, but I've also seen a lot of what the rest of the world has to offer, and I agree with Scott's assessment that an attempt to cut out the FDA cold-turkey would be a disastrophe.

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It’s rarely correct to say that *anything* is *only* something. Plenty of what the FDA does is good and proper. Most of it could probably be done better. Much of it could probably be done privately.

But yes, crony capitalism and regulatory capture is certainly a huge part of the current situation, and it would be foolish to assert otherwise.

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ISTM that we were moving in that direction before Thalidomide happened. I think a lot of pharma companies would get behind a treaty for the EU and the US to "conditionally approve" any drug approved by the other. (Conditionally would mean it would be a lot easier to revoke approval if any problems surfaced...but until they did it could be treated as if approved.)

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In the US, we have something called "breakthrough" designation, where the FDA will allow conditional approval for drugs based on surrogate endpoints (like improved lab values), while we wait for results of endpoints we really care about (like improved overall survival). Interestingly, the FDA has never rescinded approval for a drug that got conditional approval but failed to meet the later efficacy threshold. Indeed, some drug companies have failed to complete the follow-up studies and the FDA hasn't punished them by pulling the drugs until the studies are done. I imagine something similar would happen under any other conditional approval scheme.

"But if it worked somewhere else, won't it work in the US, too?" Probably? Vinay Prasad has done some great work on this. He talks about how many drug companies will do studies outside the US so they can shop around for comparator treatment regimens that have long since been abandoned in the US. It's easier to show your drug is better than the state of the art from 20 years ago, but not so much the state of the art today. Drug companies do a lot to game the system, so I would expect them to find new ways to game the system if we change it. Perhaps get the EU to conditionally approve anything approved in Australia. Then go from Australia to India, to Azerbaijan, etc.

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From Omsk, to Tomsk, to Pinsk, to Minsk...?

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I was intentional in my country selections (with the exception of the last one). The EU is the logical next market after the US for focusing clinical research, given market share. (China is probably larger, but ability to pay isn't as large. Japan is important, but EU is the focus after US for clinical development in the industry.)

Meanwhile, countries like Australia are trying to incentivize companies opening up clinical research in their country by offering some very steep discounts for doing studies there.

Then you have India, which had some pretty major scandals around 2015-2016 involving made-up/fraudulent data. Since then, Indian regulatory authorities have made major changes to increase confidence in Indian clinical research. Everyone wants a piece of this industry, given how much money is involved. The probability of a bad actor arising in a race to the bottom is not negligible. If US regulators stop caring where studies are done, a race to the bottom is inevitable.

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Dec 7, 2023·edited Dec 7, 2023

> The probability of a bad actor arising in a race to the bottom is not negligible. If US regulators stop caring where studies are done, a race to the bottom is inevitable.

I've actually been making the same point a lot in these comments, against people who think the FDA should auto-approve drugs already approved by some other regulatory agency (either EMA, or any of the G7 nations' agencies seem to be popular choices). My objection is to the auto- part, for exactly the reasons you say, but surely there's room for compromise here - are European drug trials really sketchier than American ones? If anything I'd have thought the opposite. I'm thinking some kind of reciprocal fast-track approval process, subject to the agencies demonstrating comparable standards to each other and the receiving agency checking over the trial results.

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The drug trial industry is big, but so is the pharma industry which has the direct opposite interest (making trials cheaper).

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OTOH, maybe we in Europe might just as well save money on abolishing/cutting the EMA and just approving whatever the FDA approves.

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Dec 6, 2023·edited Dec 6, 2023

I think there's absolutely a case for the G7 regulatory agencies to all fast-track approvals of drugs for which one of the others has already done the hard work.

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Seems like there could be a hybrid between this and "EXPERIMENTAL" drugs, namely that you would be allowed to sell experimental drugs with a label that says which other countries they're approved in. Not sure if that would help at all with getting insurance to cover them, though.

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Yes, that's a great idea.

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This *sort of* exists already. Regulatory bodies in a few different high intensity health economies put their heads together and developed 'Project Orbis' (which isn't an acronym, just a really cool name I think). The details are a bit complicated, but the idea is that a regulatory submission made through Project Orbis will satisfy every regulator in the scheme at once, so any regulator can pick up the work of reviewing a submission and therefore approval from any country can lead to approval for every country. Naturally there are a few teething issues (the biggest being that only oncology drugs are eligible at the moment), but products are being approved through this process, most famously osimertinib (Tagrisso)

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Is there much difference between the European and American agencies in what they approve and the requirements?

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That comment got triple-posted for some reason. AFAICT there isn't any obvious difference in the letter of the law, but the FDA seems more stringent, and is clearly much slower — a big recent case is covid vaccine approvals, for example.

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Is there much difference between the European and American agencies in what they approve and the requirements?

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Is there much difference between the European and American agencies in what they approve and the requirements?

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While I do think we need a form of overarching patient protection when it comes to drug development\factory safetey, the FDA has reached well past oversight and moved into actively causing harm by being slow and paternalistic. They likely don’t see it that way, but in their attempts to avoid the doctrine of double effect—in this case being afraid of potentially harming a few people even while most others benefit—they shut or slow down patient access to off-label treatments and compassionate use drugs which they have to green light in addition to the providing pharma company, and delay access of novel therapies to terminal patients.

They’re making an irrelevant distinction between killing and letting people die, all the while filling the invisible graveyard with patients they saved from potentially being harmed by treatment by instead letting them die. (I talk about this at length in an essay I wrote about the insane process of finding a clinical trial, https://open.substack.com/pub/bessstillman/p/please-be-dying-but-not-too-quickly?r=16l8ek&utm_campaign=post&utm_medium=web) I’m specifically thinking of my husband, Jake, who is dying of recurrent metastatic HNSCC and isn’t a Keytruda responder. There’s some exceptionally compelling research about using fecal transplants to transform non responders into Keytruda responders, and small scale studies out of UMPC have demonstrated this effect in melanoma patients, demonstrating improved responses in around 30% of patients. That’s huge. I’m a doc at the hospital where Jake’s getting treatment and brought up the possibility of performing a fecal transplant for him using a PD-1 responder donor and wrote a protocol. His gastroenterologist is on board with the idea. But the FDA cracked down on off-label fecal transplants after 2 deaths (in immunocompromised patients) around 2 years ago. For reference over 10k are performed a year for C. diff. Off-label would be any use that’s not treating C.diff. So we need IRB and FDA approval for this n of 1 study with Jake as the only trial participant. Or, Jake as the only off-label recipient. However you want to spin it. Jake consented to the risks and is fully educated about what the procedure entails. We even have a friend who meets criteria and offered to be a donor (non invasive! simple!). But it’s been 5 months of waiting and there still hasn’t been approval. Luckily Jake got into a different study that’s keeping his tumors stable. But if he hadn’t he would have died from his aggressive cancer, while the FDA protected him from the scant possibility of dying from a procedure that could potentially significantly extend his life. How kind! This is what I mean by overshooting. When I’ve made this argument in other settings, I’ve had examples of catastrophic failures of oversight given as reason why there should be tighter control over everything. Say the word “thalidomide” and it has the same effect on public opinion about relaxing FDA oversight as saying “chernobyl” has on people against nuclear power. They should exist, but they need to loosen their grip there it makes sense.

Some of the insane restrictions seem like theater anyhow. In the clinical trial essay I wrote that:

“Safety” sounds great, but the FDA is providing safetyism. There’s a process by which the FDA can fast-track a drug based on promising early-phase data, allowing the drug to come to market contingent on confirmatory trials. In exchange for accelerated approval, pharmaceutical companies will perform follow-up studies collecting additional data. The drug companies can use the drug, but they don’t always fulfill the obligations to complete additional safety testing. This kind of wild-west “give it a try” approach extended to the drug companies by the FDA isn’t extended in kind to patients who want to try certain off-label uses of established drugs of therapeutic interventions.

This kind of internal inconsistency is frustrating. The FDA is trying to do too much of everything, and instead, ends of doing a lot very poorly. I don't think there's a single solution, but rather, different areas of oversight: drugs, clinical trials, compasisonate use, etc. should all be addressed separately.

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Substack ate my reference links! Very annoying. Here are some:

Fecal transplants for improved keytruda response (this is SO COOL): https://www.nih.gov/news-events/news-releases/fecal-microbiota-transplants-help-patients-advanced-melanoma-respond-immunotherapy

What is safteyism? https://freddiedeboer.substack.com/p/safetyism-is-the-water-in-which-we

What do you mean the FDA is fast tracking then not following up on further testing? https://www.npr.org/sections/health-shots/2022/07/22/1110830985/drugmakers-are-slow-to-prove-medicines-that-got-a-fast-track-to-market-really-wo

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Since you've written candidly about all this, I hope you don't mind me asking: have you considered DIY'ing the whole fecal transplant process? It seems like the main issue would just be finding a Keytruda responder in moderately good health who's willing to be a donor? Such a person might be found through Keytruda support groups or other patient support networks. Then they need to get some screening, but I have heard that it can work fairly well to just ask one's doctor, "Hey, I'm planning to be the donor in a fecal transplant, I would like to do that more safely, can I get XYZ tests for that?". And then the actual procedure can be done at home in a few hours with simple equipment.

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Seconding this - this is exactly what I'd be doing, and I don't have an MD - it seems somebody with actual medical knowledge and an assurance they're doing it safely would be all over this, especially with loved ones' lives at stake.

Of course, us making this public likely means our good doctor can't respond to us in any way except in the strong negative, out of fear of potential medical license impacts or other liability.

I thought it's still valuable to signal boost for other folk reading here, though - the traditional and established medical channels aren't the only option. Self treatment, going overseas to countries with less-murdery regulatory regimes, going overseas to concierge doctors with broader ideas about what's medically advisable, etc. Especially if important lives are on the line, doing EVERYTHING you can to save your loved one is actually an option you can consider and do.

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To follow up on Paul Kreiner’s comments about DIY home FMT: this is explicitly not regulated by the FDA, and it is trivially easy to do. I’ve walked over 1,000 patients through it in the past decade and in my clinical experience the safety and efficacy (at least for refractory C diff infections, inflammatory bowel disease, and irritable bowel syndrome) of DIY home FMT are indistinguishable from the safety and efficacy of FMT in clinical trials. As a side-note, since FDA approved the FMT products Rebyota in Nov ‘22 and Vowst in April ‘23, they *can* be used off label, although they are ridiculously expensive. And they absolutely are not coming from donors who have responded to specific chemotherapies, immune checkpoint inhibitors, etc. There are FMT clinics around the world that I have sent patients to, but so far, none of them are selecting donors with response to cancer drugs. Outside of a prohibitively cumbersome and expensive clinical trial, the only way you can accomplish this is through DIY home FMT. I myself learned almost everything I know about FMT from other doctors who generously gave of their time over the past 15 years, and although a substantial part of my practice is educating patients about FMT during paid visits, I’ve always had a policy of educating other clinicians at no charge, which I would be happy to do for you Dr. Stillman. Feel free to send me a message (mark@IBDspecialty.com) if you’d like to chat.

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Rebyota is wildly expensive! We were quoted 10k for one round. Sending you an email

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Why default to liability on the doctor and not the person making and selling the drug?

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The doctor has a smaller budget for lawyers, so you're more likely to get a result.

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The doctor presumably knows something about the patient they're prescribing the drug to. The person making and selling the drug does not.

As an example, there was a case in the (UK) media recently about British people being 80 to 120 times as vulnerable to severe negative side effects (agranulocytosis leading to death) from metamizole as Spaniards, and as such expats died or went into comas upon being prescribed a rather popular Spanish painkiller with a low rate of side effects (for Spaniards).

Suppose you're a Spanish drug maker: you do your tests, they're all positive, you start selling the drug -- and then a tourist takes it and dies. Is it fair that you have liability here? Do you need to test on representative population groups all around the world because one of them might have an adverse reaction?

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"As an example, there was a case in the (UK) media recently about British people being 80 to 120 times as vulnerable to severe negative side effects (agranulocytosis leading to death) from metamizole as Spaniards"

That's fascinating and astounding, not something I would have expected. What is the genetic difference between the Spanish and the Brits likely to cause this, or is it just that the Brits aren't used to taking it and misdose? I mean, if we're assuming Anglo-Saxon heritage, it should be as bad for the Germans, and yet:

"In Germany, the drug is the most commonly-prescribed painreliever."

Wikipedia is just teasing me more with intriguing questions but no answers:

"Metamizole is banned in several countries, available by prescription in others (sometimes with strong warnings, sometimes without), and available over the counter in yet others. For example, approval was withdrawn in Sweden (1974), the US (1977), and India (2013, ban lifted in 2014).

Although metamizole is banned in the US, it was reported by small surveys that 28% of Hispanics in Miami have possession of it, and 38% of Hispanics in San Diego reported some usage."

What was that study about elderly Hispanic women, again? 😁

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>Is it fair that you have liability here?

Yes.....

Say there's a drill manufacturer that manufactures and sells a drill. They tested the drill in Minnesota, and it seemed safe, but it actually explodes in temperatures over 100 degrees. Then they sell it I Texas, and a contractor installing a bathroom is using the drill and it explodes and a piece of shrapnel flies off and takes off the neighbour's finger who should be liable?

I think it's reasonable to say if you're selling a product you should have a responsibility to check it is safe to use in the conditions you sell it in. And if they say on the box "warning this drug has not been tested in XXX population" then the doctor needs to make a risk benefit calculation and ideally have some mechanism to have the patient waive their right to sue if it goes wrong (which Scott has talked about before).

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So, suppose that drill manufacturer expects to sell that drill in Texas, and tests it thoroughly to not explode up to 150 degrees (hotter than any recorded temperature in Texas), sells it in Texas, to a company that installs it in an industrial lathe that runs so hot that it hits 160 degrees and explodes, taking the million-dollar lathe with it. Who should be liable?

It's not practical to always put liability on the manufacturer, since there's no way for the manufacturer to anticipate every use case. It *might* be practical for the manufacturer to test the conditions he believes are *likely*, and it's even in his interest to do that and clearly label that it's guaranteed under those conditions so that more customers will believe the product is reliable enough to buy, and it turns out that's what a lot of product manuals say.

This is harder to do with drugs, since the condition is something like "safe in the people we tested it in" and the doctor is considering that drug for his patient who might have some rare condition that makes that drug worse, and given how complicated human bodies are, this is distressingly common.

Which is why clinical trials are so incredibly expensive.

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As I understand it, the standard legal strategy is to sue everyone whom you have a vaguely plausible legal theory for suing and see what sticks. Any lawsuit that doesn't immediately get dismissed by the court gives you a chance to win at trial. Also, trials are slow, expensive, uncertain, and tedious, so defendants are very often willing to settle for at least a token amount even if they have a good chance of willing at trial, so more defendants lets you stack up more small settlements. One more factor that seems plausible but I don't know how much it applies in real life is that with responsibility uncertainly divided between multiple defendants, each defendant might make arguments in pre-trial filings that can strengthen the case against other defendants.

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My vision of an FDA-less world is one in which all drug companies immediately give up boring and not-so-profitable drugs that actually cure things, and start working on making hyper-addictive narcotics.

You think fentanyl is bad? Wait 'til you see what it looks like when Pfizer, Merck etc have sunk a trillion dollars worth of the best pharmaceutical research into the world to optimise it for addictiveness at the expense of everything else.

Now it's a simple matter of getting the whole world addicted, and gently jacking up the price until your drug is 90% of the global economy.

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Abolishing the FDA does not one would presume legalize all controlled substances.

Your ancaps would argue for that as well but your average libertarian would not.

Controlled substance classification and enforcement would still be a thing.

But I agree on the margin they'd be making things more addictive.

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I thought the average libertarian was decidedly opposed to the war on drugs and any restrictions on "acts of capitalism between consenting adults"?

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As an ex-libertarian who used to roll in such circles, there's a big difference between "end the war in drugs" and "legalize all controlled substances".

Only your proper ancaps and extremists would really hold to the exact line of no restrictions on free trade between consenting adults.

In actual fact the majority of libertarians are some kind of minarchist, (not spelled incorrectly, not monarchist) that is advocated for the minimum possible state. That is, accept immediately and right away the proper place of government as police, military, and court system. And then as far as determining what things are enforceable laws, a _presumption_ away from state action or interference into free trade or association between consenting adults, but not a total unwillingness to do so at all. Basically, the argument is, anything the state does is at the barrel of a gun, so you'd better use it only in extreme circumstances and you'd better be damn sure.

The result in practice is that the majority of libertarians I actually met or heard speak would legalize marijuana, mdma, cocaine, and hallucinogens, but probably not heroin or meth, and wouldn't balk at controlling pharma-optimized-mega-heroin. A lot of libertarians are a short cry away from rugged-individualist-conservatives and would end the war on drugs but not legalize anything except marijuana. That is, leave it illegal and prevent import / export / manufacture / distribution and just not go after users or dealers.

Only a few libertarians really are the recreational mcnukes type.

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>"That is, leave it illegal and prevent import / export / manufacture / distribution and just not go after ... dealers."

This strikes me as contradictory, but perhaps there's an elided nuance?

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The libertarian is primarily concerned with the liberty of the individual and their right to choose how to spend their days and what to put in their body.

The more you aggregate and create collectives, the less concerned your archetypical conservative libertarian is with freedom of collective action. That's not to say it's not valued, but other things also are valued. He believes in creating and securing borders (as opposed to the archetypical liberal libertarian) and would not balk at preventing international industry from importing things that were very harmful, like explosives, biological or chemical dangers, or addictive drugs. Similarly, as a cultural and social conservative, while he may be okay with an individuals choice to buy and consume a particular drug, as this concerns his direct right to bodily autonomy, this does not equally extend to a right of a mass manufacturer to produce at industrial scale addictive drugs (where the ancaps and extremists differ, as they do extend such personal freedom to essentially all actions)

A small time "dealer" is not meaningfully a distributor. He's some guy in the middle of the chain, not the manufacturer or the mass-quantity-trafficker. You can leave him alone and just prevent anyone from distributing mass quantities like a food or retail company distributes their goods.

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I've never heard of a self-described minarchist who wanted to ban recreational drugs. An anarchist wants to get rid of all government, including the "night watchman state". A minarchist wants that state to only police coercion, not engage in any kind of paternalism.

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I don't know what to tell you other than that I met em, at Porcfest and at in the formal party. If they were coming from the more conservative side it was pretty common.

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I'm not very well-informed about this, but I see a strong case that the vast majority of the harm caused by opioids is caused by their prohibition, rather than the substance itself. As far as I understand, their side-effects aren't all that bad as long as they are manufactured and dosed correctly. But due to their illegality

- People use black market drugs that may not be reliably dosed, may be contaminated, and lack basic quality control (even what would be incentivized by reputation considerations on a free market).

- People use especially potent opioids that are especially easy to overdoes, because they are easier to smuggle in a small space.

- People inject instead of taking it through other routes because a smaller dose is needed for the same effect, and it's very expensive due to the prohibition. Frequent injections of stuff that may be contaminated have bad side-effects regardless of what is injected.

- Some people share needles, which spreads severe diseases like AIDS and Hepatitis C.

- It strengthens criminal gangs, which then commit violence and other crimes besides selling drugs.

- Users may become destitute and commit crimes to get money to pay for the drugs made expensive by the prohibition.

- Imprisonment of drug users and dealers, besides harming the prisoners directly, probably has harmful knock-on effects even after they are released.

- Some people get addicted to legal prescription opiates, and then when prescription rules are tightened, they turn to the black market and suffer or die from any of the above.

Cutting through all of this by making reliably dosed stuff legal and cheap, with a big fat warning that even one try can get you addicted, seems much preferable to this.

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China did not have a great time with legalized industrial scale manufacture of opium, famously.

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It's famous for going to war to ban opium, but I've no idea how good a reason it had to want to ban it. And that was before the effects of prohibition were seen; alcohol prohibition also looked like a better idea before it was tried.

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Seconding this - most of the "deaths of despair" are due to drug prohibition and illegality. The actual drugs cost pennies - if they were legally available at a fair cost+20% or whatever at a known strength and purity, there would essentially be zero overdose deaths, and very little negative physical downsides. With pharmaceutically pure stuff, addicts can live and work and function in society for decades. Just look at William Burroughs or Keith Richards!

And a lot of the deaths are precisely due to strength and purity - the strength varies every time on the street, and with fentanyl a 1mg difference can be the difference between "feel good" and "OD." And contamination is rampant - there are 'zenes that are even cheaper than fentanyl that contaminate most street opiates now. They are cheaper AND more addictive, and they absolutely destroy tolerance in addicted people so they have to do more and more, so it's sort of a double punch in terms of incentives for illegal drug folk to include them. Unfortunately, they are much worse for human biology and orderly function than real opiates too.

And it is exactly a policy of "who cares about drug addicts, they deserve to die" in the USA that leads to these deaths too. It's at epidemic numbers, and lots of the people are people who got addicted to legal pills and then can't get them anymore because doctors are under more scrutiny and negative pressure to not prescribe any actually effective painkillers.

But for every doctor that refuses that script, they're probably killing .1 of a person due to this illegal drug purity / contamination / overdose dynamic. Deny ten scrips and statistically kill somebody! But you know, that's totally in line with Hippocratic Oaths, it would be MUCH worse to prescribe somebody painkillers that work and have very little physical downsides. Really.

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> Abolishing the FDA does not one would presume legalize all controlled substances

Who decides what substances are and are not legal in the absence of an FDA?

We could certainly continue to ban already-banned substances, but what about new ones? If Bayer comes along next week with a brand new chemical formulation for a "headache tablet" that's really really good at getting rid of headaches (and also makes you really want to take another one in three hours) then who decides whether or not that's legal to sell, in the absence of an FDA equivalent?

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I think you have a misunderstanding of what government agencies do what.

While the FDA is the gatekeeper for food drugs and medical devices for commercialization, it is not the body that decides what is a controlled substance and to what degree.

The CSA (Controlled substances act) empowers the DEA and the Department of Health and Human Services to schedule out drugs, determine their restrictions, and enforce them.

The FDA is intended as a watchdog to prevent patient risk in the course of normal healthcare business, that is, primarily by accident or corporate fraud.

It is not the body intended in any way to police narcotics, recreational drugs, controlled substances etc.

In the absence of an FDA, a company can commercialize a drug in absence of a pre-market approval, but if the department of health and human services or the DEA decides it should be a controlled substance, its a simple matter to schedule and control it.

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Fine, but what's the procedure by which the DEA would decide whether or not Bayer's new "headache tablet" should be considered a controlled substance?

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The same way they and the DHHS do it now - the FDA is not a part of that chain.

The FDA may decide whether a drug is allowed to be sold or not but them saying it can't be sold doesn't make it a controlled substance. Totally different pipelines

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Isn't it a DEA matter if I'm producing and selling prescription medicines without a prescription? And doesn't the FDA decide what is a prescription-only medication versus an unregulated one?

If that goes away, the DEA suddenly has a whole lot of new drugs coming onto the market that they need to decide whether or not to declare as controlled substances. If they choose to say "Meh, if it comes from a respectable company it must be fine" then you get the wirehead pharma-world I descried above. On the other hand, if they decide to look carefully at new drugs before deciding whether or not they should be banned then you've probably just reinvented the FDA as the DEA.

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"My vision of an FDA-less world is one in which all drug companies immediately give up boring and not-so-profitable drugs that actually cure things, and start working on making hyper-addictive narcotics."

Zero-sum fallacy.

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A new lucrative market doesn't make the existing market unprofitable.

I doubt that it's possible to make all that many novel, hyper-enjoyable recreational drugs, let alone ones where an addition can't be satisfied by different, generic alternatives. As far as I understand, if you get addicted to one opioid, another opioid will satisfy the addiction.

Why would people buy the new hyper-addictive drug, instead of the (sometimes less addictive) existing ones?

I expect that if recreational drugs were legalized, without excessive regulatory burden, the market would look more like the market for aspirin: old, cheap drugs with many competing generic manufacturers.

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I suspect that FDA could only (and in the -- however distant -- future, will) be abolished in the exact same way in which e.g. the Praetorian Guard or the Gestapo were abolished.

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> Right now your doctor doesn’t worry you’ll sue them, because “the medication was FDA-approved” is a strong defense against liability. But if there are thousands of medications out there, from miraculous panaceas to bleach-mixed-with-snake-venom, then it becomes your doctor’s responsibility to decide which are safe-and-effective vs. dangerous-and-useless. And rather than take that responsibility and get sued, your doctor will prefer to play it safe and only use medications that everyone else uses, or that were used before the FDA was abolished. You might even find it’s even harder to get a medication into common use than it was back when the FDA existed!

This is part of a genre of "we can't do without regulation" arguments that doesn't really work. The hidden premise is that the FDA has always existed.

The reason that other defenses to liability are weak is that it's presumed that only the FDA can make reasonable judgments about what medical treatments are appropriate. In the absence of the FDA, that presumption isn't available, and which defenses are strong will change.

It's true that if you abolish anything, or for that matter establish anything, and then attempt to run every other part of the world as if the change you made had never occurred, those parts of the world that depended on the presence of the thing you abolished, or on the absence of the thing you established, won't work. But that is not actually an argument that the systems they implemented will stop functioning, despite what the people making this observation usually claim.

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It does not seem like the quality of food and drugs was great prior to the founding of the FDA was very high, that is in fact the reason why it was created:

https://en.wikipedia.org/wiki/History_of_the_Food_and_Drug_Administration

In the absence of a regulatory body I would generally expect standards to decline, especially so in ways that are hard for consumers to notice.

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Dec 6, 2023·edited Dec 6, 2023

The quality of food was much higher before the problem period that led to pressure to create the FDA. The low quality was the historically anomalous period.

I think it would be fair to attribute that development of low quality to a disconnect between food manufacturers and food consumers. This made it more difficult for consumers to obtain information about manufacturers, and manufacturers responded, as you note, by becoming untrustworthy in ways that were difficult to assess. (Consumers also responded by shifting their consumption to foods in which defects were very, very easy to assess, such as white bread and large cuts of meat served with very little in the way of flavorings.)

Moving into a much more speculative area, I think it's also fair to observe that the period of low quality essentially coincided with the beginning of the large-scale distribution of food. Systems are more chaotic and display more undesirable behavior when they are new; the problem might have driven itself out of existence given more time. (There is a really interesting piece from Bret Deveraux comparing the social structures of the Mongols with those of the Plains Indians, and noting that in many ways the Mongol structures functioned better. He specifically observes that this is likely due to the Mongol social structure having developed over thousands of years while the Plains Indian lifestyle existed for no more than a few centuries.)

There are several things we might say about this:

1. The same pressure that led to establishing the FDA, if the FDA had instead never happened, would have led to something else. It is not obvious that the FDA is a better solution than the counterfactual one would have been; what we know is that the FDA was a _faster_ solution. (This point is similar to my "speculative" paragraph above.)

2. Between then and now, methods of propagating information at very large scales have come into being, making it much easier for people to obtain good information about manufacturers.

3. A punishment scheme can keep standards consistently high without prospective review. Ron Unz wrote a fascinating piece contrasting the Chinese baby formula contamination scandal with the American Vioxx should-have-been-a-scandal-but-nothing-ever-happened ( https://www.theamericanconservative.com/chinese-melamine-and-american-vioxx-a-comparison/ )

A Chinese formula manufacturer (Sanlu) decided to save costs by cutting the formula with melamine. This killed six babies and hospitalized hundreds. And the result of the state's investigation was that two company executives were executed, one got life in prison, and a handful received shorter prison terms.

By contrast, an American drug manufacturer (Merck) introduced a pain medication that -- as Merck was aware when it introduced the drug -- frequently caused fatal side effects. Vioxx was voluntarily recalled from the market when Merck learned that the FDA had discovered those side effects.

Unz:

> Although the Vioxx scandal certainly did generate several days of newspaper headlines and intermittently returned to the front pages as the resulting lawsuits gradually moved through our judicial system, the coverage still seemed scanty relative to the number of estimated fatalities, which matched America’s total losses in the Vietnam War.

> The circumstances of this case were exceptionally egregious, with many tens of thousands of American deaths due to the sale of a highly lucrative but sometimes fatal drug, whose harmful effects had long been known to its manufacturer. But there is no sign that criminal charges were ever considered.

> A massive class-action lawsuit dragged its way through the courts for years, eventually being settled for $4.85 billion in 2007, with almost half the money going to the trial lawyers. Merck shareholders also paid large sums to settle various other lawsuits and government penalties and cover the heavy legal costs of fighting all of these cases. But the loss of continuing Vioxx sales represented the greatest financial penalty of all, which provides a disturbing insight into the cost-benefit calculations behind the company’s original cover-up. When the scandal broke, Merck’s stock price collapsed, and there was a widespread belief that the company could not possibly survive, especially after evidence of a deliberate corporate conspiracy surfaced. Instead, Merck’s stock price eventually reached new heights in 2008 and today is just 15 percent below where it stood just before the disaster.

> Furthermore, individuals make decisions rather than corporate entities, and none of the individuals behind Merck’s deadly decisions apparently suffered any serious consequences. The year after the scandal unfolded, Merck’s long-time CEO resigned and was replaced by one of his top lieutenants, but he retained the $50 million in financial compensation he had received over the previous five years, compensation greatly boosted by lucrative Vioxx sales. Senior FDA officials apologized for their lack of effective oversight and promised to do better in the future.

We have here a perfect liability shield - the FDA can't be liable for Vioxx because they weren't trying to kill anyone, and Merck can't be liable for Vioxx (in a way that would actually act as a deterrent) because, sure, they were trying to kill people, but they had approval to do that from the FDA!

Which system do you think is likely doing a better job preventing counterfactual decline in manufacturing standards?

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Yes, it's large scale commercial and industrialised processes which lead to the worst adulteration scandals (see link below) but even before the "historically anomalous period" food could be contaminated, either through ignorance, the methods used (grinding grain with a quern stone meant grit in the resulting flour) or greed/cheating.

To produce food in the quantities needed for today's population, large scale processes are necessary, and that means the need for oversight. Your mention of "white bread" as one of the foods in which defects were very, very easy to assess is ironic, because adulterating bread - including things to make it whiter - is one of the complaints:

https://www.bbc.com/news/uk-25259505

"When basic staples like bread started to be produced cheaply and in large quantities for the new city dwellers, Victorian manufacturers seized on the opportunity to maximise profit by switching ingredients for cheaper substitutes that would add weight and bulk. Bread was adulterated with plaster of Paris, bean flour, chalk or alum. Alum is an aluminium-based compound, today used in detergent, but then it was used to make bread desirably whiter and heavier. Not only did such adulteration lead to problems of malnutrition, but alum produced bowel problems and constipation or chronic diarrhoea, which was often fatal for children."

And of course, where there is large scale industrialisation, there is both the necessity and the temptation to cut costs and sell at lower prices than the competitors:

https://vichist.blogspot.com/2007/12/adulteration-of-food-and-drink-in.html

"More than a decade earlier [in 1855], in his testimony before a Parliamentary committee, the Select Committee to inquire into the Adulteration of Food, Drinks and Drugs, Arthur Hill Hassall pointed out that the practice “prevails in nearly all articles which it is worth while to adulterate, whether it is food, drink or drugs.” and he went on to point out that

The majority of adulterations consist in the addition of substances of greatly inferior nature, for the sake of weight and bulk. Others consist in the addition of various colouring matters, to conceal other adulterations, or to heighten, and, as it is considered, to improve the appearance. Lastly, a few adulterations are for the purpose of imparting smell, pungency, or taste.

Among the items adulterated and the adulterants used were alum, added to flour in the production of white bread; sloe, ash and elder leaves used to adulterate tea; peas and beans in ground coffee; alum to brighten wine; Brazil wood to colour Port; and sawdust and filbert husks to make red wine more astringent. Just how widespread was the adulteration of food and drink? Certainly it varied from area to area, but it is likely that it was as great or greater in London than in any other part of the British Isles. Writing at the very beginning of the Victorian Era, Theodore Sedgwick commented that it was “difficult to mention a single article of food that is not adulterated.” Some items, he noted, could hardly be found in their genuine state. Even medicines were adulterated and the “quantity of medical preparations thus injured is said to exceed belief.”

https://journals.sagepub.com/doi/full/10.1177/23978473211033034

"In 1820, Frederick Accum published a book, best known by its biblical subtitle ‘Death in the Pot', showing the widespread fraudulent and dangerous adulteration of common foods and drinks bought in London. Despite its brief popularity, there was no effective legislation in Britain until 1875 after more extensive analytical surveys by Hassall and Letheby in 1855 and a parliamentary enquiry had confirmed the frauds and risks to public health. There were similar surveys and legal action against food adulteration in France and Germany towards the end of the 19th century. In the USA, campaigning by Harvey Wiley and others revealed the same risks and frauds and led to the Pure Foods and Drugs Act in 1906 and formation of the FDA. We should have celebrated Accum’s bicentennial in 2020 to recognise his achievement and to remind us of the continuing dangers of food adulteration today."

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Dec 6, 2023·edited Dec 6, 2023

Case study from Finland today. For context, dog and cat food intended for household pets is minimally regulated. In November, news and social media was filled with reports and videos of pets having deadly paralysis attacks. The cause was quickly pinpointed to a major brand of pet foods, which were recalled, but nobody still knows for sure why and how the dog food was contaminated: the manufacturer (Musti Group) argues that the potatoes they bought from the Netherlands were defectively high in glycoalkaloids (but claims they are not responsible as nobody expects to test dog food ingredient potatoes for that); the Dutch supplier argues the glycoalkaloid content was high but not high enough cause major side-effects.

In this case, some pets died. Yet we are not in the 19th century early industrialization information environment. Turns out, despite the internet, the assessment of quality in dog foods comes down to (a) avoiding food that obviously gives your pet a deadly seizure (b) trusting the brand you've previously bought and hoping they have not changed manufacturing process. Modern information environment makes information about (a) spread a little faster, but it helps only if the harmful effect is obvious and already killed someone else's pet.

If the regulation of human foodstuffs were reduced to similar level as dog foods, it seems likely that we'd have similar cases with bad or adulterated human foodstuffs are noticed only after someone dies after eating a product that turned out to be clearly poisonous ... coincidentally similar to the Chinese melamine adulteration case. If one compares melamine and Merck, Merck was not stupid enough to sell a product that contained large amount of chemical that is known to kill your baby just to make it look like it passed quality control; they sold a painkiller that sort-of did what it promised but also had known prevalent but not ubiquitous harmful effects. The Chinese melamine milk producers had been going unnoticed and unpunished for years as long the producers added amounts of melanin that was still harmful but didn't obviously kill babies. Nobody went prison or was executed for killing babies slowly, their mistake was increasingly adding it so much that many babies started dying immediately, which couldn't go unnoticed.

The part in the Merck case that appears the largest injustice to me has nothing to do with the existence of FDA or its regulatory tasks, but the feature of the US legal system where the executives who make money killing people can often escape unscathed with minor personal consequences by having the corporation to pay large monetary settlements (I don't think such cases are limited to FDA only, American system is famous for out-of-court settlements and plea deals).

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Dec 6, 2023·edited Dec 6, 2023

> The part in the Merck case that appears the largest injustice to me has nothing to do with the existence of FDA or its regulatory tasks, but the feature of the US legal system where the executives who make money killing people can often escape unscathed with minor personal consequences

I did explicitly make the argument that that feature of the US legal system is due to the existence of the FDA.

> If the regulation of human foodstuffs were reduced to similar level as dog foods, it seems likely that we'd have similar cases with bad or adulterated human foodstuffs are noticed only after someone dies after eating a product that turned out to be clearly poisonous ... coincidentally similar to the Chinese melamine adulteration case.

That is also what we have right now. Do problems occur with the dog food in Finland more often than they do with the human food?

(Compare this relatively recent American scandal involving human food: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/chipotle-mexican-grill-agrees-pay-25-million-fine-resolve-charges-stemming-more-1100-cases-foodborne . Nobody died, but that's just a coincidence.)

I'm not sure what you're trying to tell me with the example of the dog food. If it had been regulated more heavily, what would have happened differently?

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Honestly, I think "Carve up the FDA" is a better plan than "Abolish the FDA". Remove more and more of their control over medicine, starting with the easiest stuff.

Step 1: Remove AI tools and medical devices from their regulation.

The argument here is simple, the FDA is not competent to regulate AI in healthcare. A ton of new "AI" medical devices have been approved, per Wu ~500, and I'd bet that 80% of them are crap because, well, reality. But there's a ton of AI products that are going to hitting hospitals over the next 5-10 years. And the FDA, to the best of my knowledge, has nowhere near the technical capacity to understand these tools or regulate them in a meaningful sense. With all due respect, at worst they're bureaucrats and at best they're pharmacists, neither of which qualifies them to regulate AI or, frankly, even read some simple Python code.

And we had a perfect example of this with the Epic EMR and their Sepsis prediction model v 1.0. It came out, lots of hospitals adopted it, some ran their own numbers to check their effectiveness, found out Epic significantly overstated it's effectiveness, Epic went back and came out with a new version that genuinely seems better, various hospitals are still evaluating it, and at no point was the FDA involved because....why would you? If a new "AI" device drops and it tries to alert a nurse when a patient at home is potentially having heart problems, whether that's effective or not, especially when faced with an exasperated nurse and 20 false alarms, is a decision for the hospital.

So keep the FDA out of field it's, with all due respect, not qualified to regulate.

Second, cut out medical devices in general:

My CPAP probably isn't going to kill me and doesn't need to cost $3k...this is pretty settled technology. And, again, the FDA isn't engineers, it doesn't build stuff, why are they regulating this?

Now I'm more hesitant here, because there have been a number of dangerous medical devices and there's real danger here and legitimate problems. And I pretty clearly want some sort of regulation of pacemakers, for example. But it sure seems like there's a lot of easy money to be saved in removing regulation from...non-surgical medical devices, for example.

Finally, tackle drugs. Which, ick, for reasons laid out above.

But I should stick up "Abolish the FDA" a bit here by suggesting that politics in the US might...not allow us to pursue our policy goals in as sensible and circumspect a manner as we might ideally like. And while it pains me to suggest that our noble civil servants might undermine or ignore any laws or executive orders they personally disagree with, I think any Libertarian president might want to consider simple and easily verifiable plans rather than detailed and surgical ones. In an ideal world you might want to slowly carve away at the authority of the FDA, and you might even find that their performance improves as their mission gets smaller and more coherent, but in our fallen world of...not ideally functioning politics, we may be left with "Abolish the FDA" or "status quo".

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Dec 6, 2023·edited Dec 7, 2023

(Im in the med devices industry)

The FDA already has in place a classification system for the risk profile of a medical device (class 1 2 or 3 (or "not a medical device))

To be honest cutting out the class 1 devices from their purview entirely would be pretty risk free. - but it nearly works this way already. To commercialize a class1 requires paperwork and a promise that you have a system for hearing about it if people use your device and have complaints. There's no approval process. (requires registry only)

More generally, and this is commonly misunderstood, In the med devices space the FDA are NOT the arbiters of whether a device is safe and effective. They are actually just an organization that sets a standard of due diligence and checks whether you followed it.

(Clarification edit for wording. The FDA is not a panel of technical experts that themselves evaluates the safety and efficacy of a device. They are a panel of regulators that sets standards for what it means to be safe an effective, tell industry to do the work proving it, and check their work)

They are not engineers or even doctors really and they know this - they make no attempt to "understand" the technology such that they could decide whether it's risk benefit profile is acceptable (though contrary to popular belief, risk benefit analysis is baked into the regulation at all levels, it's cost / benefit that isnt)

Rather, the FDA requires you to make a clinical trial, do your own testing, with competent third parties and doctors, and _they_ are the ones who say whether it's safe and effective, and the FDA just needs to be able to trust their credentials. They will look at your study design and data and see if they agree, and ask questions where they don't. In practice this still ends up cumbersome because they can ask about any kind of data and halt you til you get an answer and trials themselves are difficult and time consuming.

But, the one elegance of the system is that it can actually do it's job explicitly without the FDA needing to be subject matter expert or understand the treatment or modality. They just need to understand study design.

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It's really great to have a comment from someone with actual experience in the field. For me, one comment like that is worth 10 or 100 from theorizers. Similar kudos to the fecal transplant post above.

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Agreed, comments like the one above are the main reason I even read the comments section.

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Thanks for the response, that was very insightful.

I find myself confused though. So the FDA just...double checks the study, at least for medical devices? Like, all the testing and analysis comes from reputable third parties and the FDA just double checks their credentials?

Is this similar for drugs? Does the FDA do more for drugs, do they have actually specialists or is it also just reputable third parties?

Because two notes:

First, this kinda makes abolition sound...sensible. Like, if all the FDA is doing, fundamentally, is double checking qualified third party experts, it doesn't sound that crazy to just abolish the FDA and hospitals and doctors judge off the third party experts. Not that this sounds faultless but, I mean, as far as I can tell the bond markets are based on independent third party experts like the S&P rating agency. Which is far from ideal but if we abolished the FDA, what's the prevent the expert market from consolidating into a few medical device "rating agencies"?

Second, genuine question, does anybody know who and how the FDA is approving these new medical devices? Because ML prediction algorithms don't...work fantastically with standard studies. I don't want to step too heavily here, I'm not that much of an expert, but I know plenty of ML prediction algorithms have had ugly failure modes because their training data was limited to 2-3 hospitals and so those algorithms don't generalize to the wider population, or more appropriately, other niche populations. Any links would greatly be appreciated.

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Okay, a bunch more detail.

1. I'm really familiar with medical devices but not at all familiar with drugs and from what I hear that's a different animal altogether. So, can't say anything about how the FDA does drugs.

2. So, you want to commercialize a new medical device? Here's what happens.

A. If your device is simple and non-critical and has a low risk profile, like a laparoscopic grasper or chest retractor or blood pressure cuff, your device is a class 1 device. You will create a "Design History File" which includes the user of the devices needs from the device, the engineering requirements that satisfies those needs, a set of drawings and specifications that fully define a device that meets those needs, and then probably only one kind of testing which you will run yourself, checking that a device made to your drawing meets your specifications, in an objective manner.

Then youll have a way to prove that the manufacturer is building that same device. You do a pre-market registration with the FDA, where you notify them you are selling this and where it's being manufactured, and you're done.

All of this has to be well documented with traceability. If your device has complaints the FDA may look into it.

For class 1 devices a lot of this can be left out and does based on the size of the company but if you do at least the above you're in good shape if the FDA checks and it's usually just good practice engineering anyway.

B. Your device is potentially critical and could be risky, but it's based off something that already exists and so you can make pretty good guesses about it's risk profile. This can include basic implants, monitors, surgical devices, etc. Your device is class 2.

You will be using the "510K" submission pathway, where you demonstrate that your new device is substantially equivalent to a device or combination of devices that already exists.

Your design history file will include all of the same as before, with the addition of the following: documented design reviews at a minimum of 3 defined stages in the product design. Documented "risk evaluation" where you assess what the likely failure modes are, what happens if they occur and how bad it is and develop a semi-quantitative sense of risk level, and then implement risk controls to address each until they are acceptable.

A second kind of testing, where a licensed clinician uses your device in a simulated use environment and agrees that the device made to your drawing meets the needs of the user.

Statistical process qualifications of the manufacturing process by which the manufacturer will make.

A clinical registry, where once you start selling the device you'll be carefully tracking the first physicians who use it and checking their outcomes.

A few other documentation requirements but this comment is already too long.

C. Your device is critical to the patient, risky, and brand new. Your device is class 3 and you will need a pre-market approval, i.e., a clinical trial.

You'll do all the same documentation and testing as in (B), plus a bit more, but the big difference is that you run a clinical trial before you can sell anything.

The results of the clinical trial are outcomes and judgements made by clinicians. Typically you run these with a third party who specializes in doing so.

So the FDA receives your submission and reviews it. The first thing they do is check your argument for classification. If they disagree with the device class your submission is DOA. A lot of new devices get held up here - tiny companies who have sold a class 1 and the FDA scrambles to tell them no that's a class 2 stop, or much more frequently someone trying to say something is class 2 and the FDA is t convinced and says it's class 3.

This is a partially expert opinion call, but they have some fairly objective ways of making it that are honestly pretty decent: devices are the same if they have the same intended use on the same patient population and use broadly the same modality.

Usually the disagreements are when there's different intended uses but sometimes the FDA won't buy that the modality is similar enough.

The FDA then goes through your submission, checks all your documentation and testing and data and the outcomes of the data.

If they're confused or disagree with something, they will ask you for additional information, and possibly data.

If youve answered all their questions to their satisfaction, and in the case of class 3 completed the trial, congratulations you can sell a medical device.

But we're not done yet

In addition, the FDA also audits you on an irregular basis, to check whether you have a defined procedure in place for creating all that documentation and running the testing etc and for capturing that it happened and that it happened the way you said it did. If you fail an audit you may have to make corrections or may have to not sell devices.

They also perform inspections in manufacturing facilities and audit them similarly but with experts on manufacturing facilities. Here they really do have subject matter expertise.

They also are tracking the healthcare space and looking for complaints or devices creating bad outcomes, and require you to do this as well. If the device is not performing, they are the watchdog for when you have to recall your device. (In practice no one let's it get so bad that the FDA has to tell them to recall, they do it themselves first because if mom has to tell you to stop you're in trouble).

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3. For the review of special cases, the FDA does keep on staff some genuine technical and medical experts. But for the review of business as usual submissions, they are not involved.

4. The FDA typically leaves the design and performance of a device totally up to the designer, but they do have in place a list of industry standards for basic and very quantifiable things that your device is required to meet (things like biocompatibility of materials, sterile barrier packaging tests, etc)

5. Honestly the main risk o see of dissolving the FDA specifically in regard to medical devices is a lot of companies commercializing devices made to varying engineering standards, that have only been tested internally, manufactured in facilities that are poorly controlled, especially ones that really should have had clinical trials.

There is a lot of pressure for this in the space already. I absolutely do not believe companies would perform this testing if they were not required to.

6. In regard to AI, the big fight that's going on right now is companies trying to make an AI based device and arguing it's a physician _aid_ and not an alarm or diagnostic modality, and therefore class 2, and the FDA saying look we all know damn well they are going to just trust the machine or they wouldn't use it and you wouldn't sell it, it's class 3, and imo both arguments have merit. That pushes the AI algorithms into clinical trial land. And until they can consistently get good outcomes they won't be approved. Tbh the FDA doesn't need to understand AI, if you can demonstrate your device achieved good outcomes with low risk according to the defined statistical practices, they will let you. But nobody wants to run an AI trial.

On the bright side, after a bunch of AI class 3s HAVE been made, someone will be able to claim equivalence and then some of them will start being class 2s.

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Dec 7, 2023·edited Dec 7, 2023

Finally, admittedly, the FDA can be pretty arbitrary with what they ask for in a submission. We've never been able to predict what things they'd be confused about and ask for more data on ahead of time. And for anything shiny and new (AI) they are much more inclined to ask to show more work and data regarding risks. This can really bog things down and make it take a long time and a lot of money.

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Nobody wants to run an AI trial because they don't think it'll be successful?

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Depends on the particular use of AI. But mostly nobody wants to run an AI trial because it's cumbersome and impractical to set up. (Read: expensive and time consuming)

In the case of a hospital alarm system like mentioned before somewhere, to have a proper control and experimental group would probably involve a dozen hospitals and hundreds of patients. Or in the case of using AI to interpret some kind of massive diagnostic data set, the trial required to properly vet that might demand enormous numbers of samples, especially if no one can tell you how the AI works under the hood.

To a first order, whether you have to do a trial for an AI or not is a difference of at least one and probably 2 orders of magnitude in terms of cost to actually release your device.

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Where did you get the idea that the FDA isn't the arbiter of whether a device is safe and effective? How, then, did the FDA stop 23andme from helping people interpret their genotype? (Answer: They claimed that a microarray was a medical device, and that it needed to go thru the full approval process.) How has the FDA managed to block the introduction of broad-spectrum genetic pathogen-detection tests for decades? I've spoken to several companies who sell such tests overseas, and all said they will never sell them in the US, because of the FDA.

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Hey, the wording was unclear, ive added the following edit to the top level:

(Clarification edit for wording. The FDA is not a panel of technical experts that themselves evaluates the safety and efficacy of a device. They are a panel of regulators that sets standards for what it means to be safe an effective, tell industry to do the work proving it, and check their work)

They dont scientifically evaluated whether a particular device is safe or effective, they are a group that makes sure you proved it before you sell anything. Sorry for the poor choice of the word arbiter (since that word has such strong associations / connotation with gatekeeper)

Does that answer your question?

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My question was rhetorical. Your post suggests that the FDA doesn't have the power to keep "medical devices" off the market for stupid reasons, and to apply the term "medical devices" outrageously broadly. Yet they have done so, over and over again.

23andme takes your saliva and runs it on a microarray that detects 640,000 different SNPs (single nucleotide polymorphisms). They used to have software which then checked the disease risks associated with all those SNPs, and provided the user a summary showing which diseases they had an elevated risk for.

The FDA declared that this constituted a medical device, and that 23andme needed to go through the approval process for EVERY ONE OF THOSE 640,000 SNPs. That's 640,000 different approvals.

It was stupid to pretend that the microarray is a dangerous medical device, and it is stupid to demand going thru a regulatory process on literally every nucleotide in the human genome before you can tell a patient anything about it. And this kind of abuse of power is not the exception, but the rule. The business with banning broad-spectrum pathogen tests is far worse, and has probably killed millions of Americans.

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I dont think my post suggests that at all, in fact its exactly for the reasons im trying to describe that such a thing as the above can happen - The FDA are not scientists, doctors, or engineers. They are regulators working within a constrained definition of what a medical device is, and if something meets that definition they expect an approval process, and they arent capable of understanding the technology scientifically in order to know when to make an exception or change their protocol.

They are the gatekeeper, but not because they do the math, because they make you do it.

I dont disagree that this results in a lot of stupid things. Im just explaining how it works.

Frankly, such a product really _does_ seem like a medical device, but one that should probably have a single submission altogether. But like I said in my later post, most of the sticking points on a project is the FDA disagreeing with the classification and requiring arbitrary things.

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Ah, sorry. I interpreted "the FDA are NOT the arbiters of whether a device is safe and effective" as "the FDA doesn't regulate devices". I didn't interpret your statement within the context of the comment you were responding to, which said the FDA doesn't have the expertise to do so, but instead only in the context of Scott's post.

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As a libertarian who wants to abolish the FDA (and every other government agency), my answers to your questions are:

1. Are we also eliminating the concept of prescription medication?

Yes, in the sense that people should be free to put whatever they want into their own bodies. If patients, doctors, pharmacist, pharmaceutical companies, insurance companies, or others find the concept of prescription medication useful, they can recreate it for those who want it while leaving the rest alone.

2. Are we also eliminating factory inspections to make sure drugs aren’t contaminated?

My answer is essentially the same as to the previous question.

Factory inspections are probably useful, and could probably be even more useful if done by people with better incentives than the FDA.

Factories could be inspected and certified by organizations created for that purpose. These could be anything from for-profit companies to non-profit patient organizations.

3. How do we deal with the fact that many doctors are dumb?

Certainly not by replacing them with even dumber bureaucrats. At least the good drug is also available in your scenario. In the equivalent scenario with the FDA, only the bad drug would have been approved.

No system can create the optimal outcome every time. The FDA certainly doesn't. Sometimes doctors make mistakes or act maliciously, but the harm caused by such events is smaller and easier to deal with than when bureaucrats and politicians do the same. When a doctor is malicious or incompetent, the only challenge is finding out and convincing everyone else. That may be a big challenge, but even that's not enough when the FDA is malicious or incompetent because the FDA doesn't need the consent of the people it has the potential to harm.

4. How will the smart doctors get the data they need?

I don't share your confidence in the FDA reliability. The FDA's ability to enforce its decisions creates bad incentives because it means that it doesn't need the trust of patients. I think that also makes the agency easier to manipulate compared to a voluntary organization because there is no counterweight to the individual decision makes' incentives to maintain good a good relationship with the large pharmaceutical companies that they often end up working for once they leave the FDA.

Regarding supplements, I would assume the reason there are not as many studies into their safety is that unsafe supplements are a relatively small problem. How likely are people to die or suffer serious injury after consuming supplements compared to FDA approved drugs? What are the consequences of the average supplement not doing anything compared to the average FDA approval drug not doing anything? I don't know the answer to those questions and I could be wrong, but I suspect they explain the lack of large scale studies.

5. What would insurance cover?

That should be decided by patients, doctors, insurance companies, mutual aid organizations, etc., not by government agencies.

However, if you don't want to reform the healthcare system, I assume there is already a system in place for determining what insurance companies have to cover when it comes to procedures such as surgery, physical therapy, etc. that is outside the FDA's remit. That system could perhaps be extended to cover drugs as well.

While I would abolish the FDA in a heartbeat if I could, making the FDA advisory and voluntary by removing their enforcement powers as DavesNotHere suggests would be an acceptable compromise. Almost all harm caused by the FDA comes from their monopoly and their ability to enforce their decisions by force.

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Thanks for providing actual answers!

What happens in a situation where a drug has good effects for most people but unexpectedly causes death to a few? While the FDA frustrates a lot of beneficial medical innovation I worry that without it private lawsuits could have an even bigger chilling effect.

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That's a good point. Lawsuits could definitely lead to a chilling effect that limit access to drugs even without the FDA if pharmaceutical companies are forced by law to accept liability. That wouldn't be a problem if liability was regulated by contract rather than law.

The amount of liability that it makes sense for a patient to expect and a pharmaceutical company to accept would probably vary wildly depending on the drug and the context in which it's used. A patient probably wouldn't care nearly as much about the chance of getting compensation if something goes wrong if they take the drug in a last-ditch attempt to save their life compared to if they take the drug to treat something less serious or if there are other treatments options.

The amount of liability a pharmaceutical company is willing to accept for a drug when there are multiple competing drugs available can also serve as an indication of how safe the drugs are, as a compliment to independent certifications and studies.

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So you'd need to sign a contract with each customer? I... don't actually see major problems with that. Obviously creates a bit of a transaction cost but eh. Prescription meds are already transaction costed out the wazoo.

I kind of expect that pharma companies would just waive all liability as a default though. Even if you're selling basic ultra-safe paracetamol, the cost of one random person dying and their family trying to blame your pill for it could easily be high enough that it's just easier to say "buyer beware".

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There should be some default, but it should be alterable in contract.

One possible default is that the manufacturer is only liable for whatever they explicitly state on the box or in the leaflet. Then the "contract" doesn't need signatures, so it has little transaction cost.

If the box only states that it contains 30 pills of 5 mg fluxomoxacil each plus these-and-these excipients, they have fulfilled their duty as long as they actually give you 30 pills of 5 mg fluxomoxacil and excipients, regardless of what effects that has on you. You probably shouldn't take this unless it's recommended by a doctor who knows what fluxomoxacil does.

If they state that here is the list of side-effects and their prevalences, they are liable for any side-effect that's not on the list or more prevalent than that. If they also say that they limit their responsibility to no more than $100,000 per patient, that applies.

If they state that they have done FDA-standard clinical trials (or some FDA-equivalent if the FDA is not preserved even in an advisory role), and here is the list of *known* side-effects and their prevalences, they are responsible for that being true, but not for any unknown rare side-effects.

If there are many scandals of people dying from unsafe drugs, people will pay more for drugs that make stronger promises.

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This is my preferred system too. It almost seems like common sense to me.

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This is definitely what I expected the lib answer to be: liability law makes all the above manageable.

But thats where they lose people, who respond have you actually SEEN liability law? Its insane.

For my part I could believe liability law is the lesser of two evils, but would appreciate more effort showing its not quite as terrible as everyone thinks it is.

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Started fine, but I felt Scott had already done other - dare I say: better - suggestions for reform, didn't he? With a four star system of FDA approval, I vaguely remember. Not just: new supplements - experimental - the ol' stuff. On SSC I a quick search only turned up https://slatestarcodex.com/2013/11/26/a-letter-i-will-probably-send-to-the-fda/

which is a fine but different story. Was it on ACX?

That said, the new supplements should make all libertarians happy enough. Though I wonder: Won`t many of the bad outcomes described for an "FDA deleted" still apply?

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I agree with you that making the FDA optional (which is sort of what legalizing artificial supplements would do) is a better solution that abolishing it. Selective deregulation is not the same thing as a free market, at all.

I don't think your "abolition would be bad" arguments are quite as strong as they appear, though. I don't think supplements are the only relevant comparison. Their high degree of safety and low price (for the most part) goes a long way to explaining the paucity of evidence. I also think the existence of the FDA drives more dubious claims into the supplement market. Take the personal computer market for example. There is reliable evidence about performance and reliability characteristics which experts (e.g. system integrators) can reliably interpret to recommend things to lay clients, sort of like doctors do for medicines. There's no compelling case for a regulator here. It is not the case that a PC hardware company can make a terrible product and make billions in sales anyway with slick marketing.

I think the ideal starting place for reform is insurance, not drug approvals. Meaningful price signals are necessary for a functioning market.

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Tired: Abolish the FDA.

Wired: Reform the FDA.

Inspired: Develop really good drug-evaluation AI that does the FDA’s job super fast.

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So instead of infinite paper clips killing us all, we’ll have an AI torture us to death with medication „studies“ GlaDOS-Style, because the best representative study is of course testing everyone on every drug. For science!

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Nope. It works just as well to test using a good large representative sample, and AI would know that.

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I thought it’s going to be too intelligent for us to comprehend. How can *you* know what AI is going to know and derive to be best?

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I like your two proposed solutions, but I disagree with your assertion that "if you throw the average 2023 American into the jungle, they will die within days." People would certainly be unhappy and uncomfortable, but I think humans are far more resilient than you give them credit for. When push comes to shove and a human's life is on the line, they have a strong tendency to get over themselves and figure things out.

The jungle is harsh, and survival is hard, and your life expectancy is certainly going to go down. But you aren't going to just lay down and fail to find water or stand by while a tiger gnaws on your leg. Take a look at Uruguayan Air Force Flight 571 for an extreme example of how modern humans will "figure it out" when they need to.

I think if we remove this assumption that humans are incapable of "figuring it out" without the state telling them how to live, then the "just delete the FDA and DEA" solution becomes "viable" (for some definition of viable) and at least worth considering IMO. Your alternative solutions may come up superior depending on how you measure success, but I don't think they are automatic wins no matter what metric of success you choose.

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"Throw us into the jungle 2024" is not a great election campaign slogan, irrespective of whether the average person would eventually learn to eat a raw jungle mouse!

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If the goal is "to get votes" we have strong evidence that "regulate more" is the optimal strategy (because people that advocate for that historically get elected, while people who advocate for any regulatory reduction don't).

If the goal is to have a plan that may plausibly work over the long term, then Scott's suggestions or the "just delete them" fulfill this requirement.

It would be cool if Scott's plans were sufficiently friendly to the average voter to get them to vote in a direction of such things, but I'm quite skeptical on that.

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A plan that would work long-term while causing its implementers to lose elections is like an airplane that would fly if there was air but no gravity.

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By that metric, I think both of Scott's proposals are out as well. This is a serious problem with current US politics IMO; there is no "political will" to remove/reduce regulations, only to increase them.

So either we are discussing options that could solve the problem, regardless of whether they are something a politician could run their platform on, or we accept that for now there is no viable path to significantly reducing regulations and we discuss how we change that.

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I’m ideologically opposed to almost all consumer protections of which the FDA is maybe the best example. So let me tell you about my libertarian fantasyland, in which consumer protections have been eliminated. People prefer safe food, drugs, etc; so let the free market figure out how best to meet their needs. I imagine that a complicated mixture of partial solutions would emerge:

Liability is one important solution. Even without the FDA, you should still get sued if you lie about your drug and it makes people sick. Maybe drug vendors are still required to purchase liability insurance. This should cover a lot of concerns about potential harms, e.g. “Are we also eliminating factory inspections?” Answer: yes, as long as you can afford the insurance!

How do we deal with BadCorp? Maybe I’m naive but I am a lot more optimistic about certification than you seem to be. “NEVER RECOMMEND UNCERTIFIED DRUGS” is exactly the sort of simple norm which I suspect would be very easy to install in the medical establishment. Similarly, I think it would be easy to establish a protocol where certification bodies publish whatever data the smart doctors need in a standardized format.

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> you should still get sued if you lie about your drug and it makes people sick.

Correct me if I'm wrong, but your comment seems to be treating "lie" and "makes people sick" as if observers can easily reach consensus on when these occur. If a company promised that e.g. bleach injection was a safe cure for COVID-19, and most bleach-injectors died rapidly, then that would probably work.

The more likely scenario in FDA-free libertarian fantasyland is that no new drug is rapidly fatal as often as bleach injection would be, and thus it becomes hard for observers to reach consensus without... studies.

But what sort of studies?

As Scott wrote,

> The only reason we have big, less-than-completely-manipulated studies is that the FDA demands it, and employs lots of experts to figure out which studies have been manipulated or not.

Why should the judicial system take over the FDA's role in mandating big, less-than-completely-manipulated studies? Why would we trust judges and juries with data analysis more than we trust FDA bureaucrats?

If that's not what you're proposing, then how are the lawsuits resolved? On the basis of small, completely manipulated studies?

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Dec 6, 2023·edited Dec 6, 2023

For all its faults, one of the benefits of the tort system over a bureaucracy like the FDA is that if nobody with standing objects, then the former does nothing. The FDA will prevent dying patients from using experimental drugs, even though these people would never bother suing the company for selling them experimental drugs.

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" Even without the FDA, you should still get sued if you lie about your drug and it makes people sick."

So how libertarian is this fantasy land? As libertarian as Negidius describes above, where you can put whatever you like in