>can the FDA actually stop or sanction experimental procedures like this?

They explicitly permitted this operation, by means of https://www.fda.gov/news-events/public-health-focus/expanded...

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Yes, the FDA will insert itself to regulate medicine wherever it can. For example, the FDA has been pushing to regulate diagnostic tests as medical devices.

It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues

I have a weird muscle disease that is treated with just taking over the counter L-Carnitine. The issue, vitamins and supplements are not regulated. So, I will try to take a new brand and after a few days my symptoms will come back because the pills don't have the L-Carnitine like it says and there is no one to make sure it does. It will cost me four to seven days of pain, and no one is held responsible.

My best guess is one in a thousand actually needs them so the 999 have a placebo effect and the 1 suffers. I told my neurologist, and he couldn't even prescribe them for me because that isn't a thing. So now I buy all I can find that works and hope they don't stop making it.

I don't know if this helps you, but in case it does: They are regulated in Australia. Products that conform will have an AUST R or AUST L number on the packaging.

I learnt this at a talk I went to about 10 years ago. At the time, in the speakers opinion (who from memory was involved in surveillance testing of these products), some countries did regulate stuff like vitamin supplements, but Australia was the only country that "did it properly". And a major component of this was that their regulations covered ingredients and the supply chains.

A quick search turned up this article: https://www.tga.gov.au/blogs/tga-topics/how-are-vitamins-reg...

Finally, a word of caution given by the speaker: many companies/suppliers try to trick consumers online by selling cheaper versions with identical labelling but no AUST number and shipped directly from overseas so it technically counted as a consumer "importing" on their own. Idk if this loop hole still exists.

That sounds severe enough I'd consider it worthwhile to pay a lab to run spectroscopy on a range of supplements just in case, or consider hiring a lab to synthesize a batch I _know_ will meet my needs. The first option is probably a lot less pricey than you'd expect.

Do you have any proof the supplements don’t have l-carnitine? You should get a lawyer if so, that is an easy case against the supplement maker imo.

The whole supplements industry is like this. The best you can do is get one that’s USP certified.

> So, I will try to take a new brand and after a few days my symptoms will come back because the pills don't have the L-Carnitine like it says and there is no one to make sure it does.

Unlikely. What's more likely is that something else interferes with the absorption.

Anyway, don't just take my word at face value, have a sample tested: liquid chromatography can give you an answer quickly. Also, don't buy on amazon where cheap fakes and inventory comingling make the problem unsolvable.

Grab a monster energy drink: content in L-Carnitine is guaranteed,

Have you considered skipping the shady middleman altogether and just ordering the pure stuff directly from a manufacturer?

I had to spend thousands to go through a dozen medications for medical issues. Eventually turned to supplements in part because it was much easier to experiment.

I have a couple meds and treatments I’ve been begging doctors to try, but they aren’t aware of them so refuse to consider.

Go onto any support forum and you’ll find countless tales of doctors not listening or not knowing current info on a condition.

You'll also find tons of people who swear by their home "witches brew" medication. People who are just feeling a placebo. Or people who think they have the forum's banner illness but actually have something totally different and much more benign. They heal over time naturally, but attribute it to gum root jelly concentrate.

I've been there a few times before. And while inevitably monkeys popping random pills will find something, separating the signal from the noise takes time and studies. The things that doctors pay attention too.

Disclaimer: Yes there are out of touch doctors and yes random medicating has lead to amazing discoveries.

If there are two brands exposed to the same market rules and one cost half the price there is a fair possibility that will contain less amount of the expensive active stuff and more of the cheaper ingredients. Technically is still carnitine, but one can have 90% of carnitine and the other just a 60%.

> For example, the FDA has been pushing to regulate diagnostic tests as medical devices.

I assume you mean COVID home tests and things like that? Call me strange, but if I buy such a thing then I'd like to make sure it's held to some standard of accuracy and safety. I do not have the resources or knowledge to find this out myself. Most people don't, and you can't just rely on "internet reviews" or the like.

Someone has to do this, and while the FDA and government authority may not be perfect, they're the best we've got, and we can at least somewhat hold them accountable through the democratic process (which also isn't perfect, but better than anything else we've got).

I'm surprised by the popular take on this. Hasn't HN spent the last 3 years lamenting how the FAA ceded too much regulatory power to industry?

... because this is where it starts. The answer to "there are regulatory inefficiencies" is not "get rid of regulations" or "allow industry to self-regulate."

Right? Like why shouldn't they regulate diagnostic tests? Do you expect the free market to do it?

> regulate diagnostic tests

If only there hadn't been a major high profile collapse of a fraudulent diagnostic test company recently.

The hostility towards FDA on HN is incredible. I wouldn't trust some VC funded startup bros with anything related to medicine at all without having passed every single regulatory board tangentially related to whatever they are doing, even more so after Theranos.

It's not like "enforce more" vs. "enforce less" is the only axis along which the behaviour of a government agency can be tweaked.

For an extreme example, imagine you had a court system that picks 100 people at random to execute each year (most of whom are naturally innocent). Then, you have a crime wave. Would you say that the solution to this problem would be that the courts need to be tougher? ...more lenient? Both seem quite obviously wrong: being more lenient would solve the problem of innocents getting executed but do nothing about crime, being tougher would only trivially solve the problem of crime near the limit point where everyone is executed. However, being hostile towards such a court system seems quite appropriate.

Likewise, I don't think Theranos is sufficient evidence that the FDA needs to simply be stricter, nor is the difficulty of getting approval for pig hearts sufficient evidence that the FDA needs to be more lenient. Instead, taken together the two imply that the FDA needs to be more specific at blocking the bad therapies and allowing the good ones - in other words, it simply needs to get better at its job. Is this not something we can demand of the government?

> it simply needs to get better at its job

The issue here (and with regulators in general) is that in general "being better at their job" means going into more depth to determine whether an approval is warranted, which means expending more resources on investigation. I don't know that I've ever seen any overlap between the people who think the regulators do a bad job at regulating and people who think we should be funding the regulators more thoroughly.

All that not to mention that when a regulator like the FDA starts going into more depth in its investigations of an industry, that industry's firms start spending more money on either complying with or deceiving the regulator, risking a downward spiral of wasted resources.

But the FDA isn't executing 100 people (or corporations) per year. FDA isn't even indiscriminately halting progress. Your argument has no premise.

The FDA regulates with cause and investigates all new medical products before they can be brought to market. They don't willy nilly approve some and nix others.

I wouldn't trust startup-bros either, without regulatory oversight. That being said, the hostility towards the FDA is not without basis (see below). Though I would argue that much of that hostility it due to it doing too little, rather than too much.

Why is the FDA Funded in Part by the Companies It Regulates?

https://today.uconn.edu/2021/05/why-is-the-fda-funded-in-par...

Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns:

https://www.science.org/content/article/hidden-conflicts-pha...

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice:

https://www.jabfm.org/content/17/2/142.long

Revisiting financial conflicts of interest in FDA advisory committees:

https://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12073

(edit: more links)

Why? Because citizens want an expert-staffed and functional regulatory body, but aren't willing to pay the tax necessary to fund it, at parity with private sector salaries.

The root of all government problems is "We trust you to make decisions that impact a large amount of monetary value, but also pay you less than the amount of money flowing through you, and also pay you less than private industry would be willing to."

Which... sets up an interesting dynamic.

There are a lot of selfless saints out there. But there are also a lot, not. And so internal processes and regulations pile on top, in an attempt to curb the worst of corruption.

Can we make the system better? Eh... maybe? But it's important to remember that a lot of features that look insane are actually reactive solutions to problems inherent in the system.

> Why? Because citizens want an expert-staffed and functional regulatory body, but aren't willing to pay the tax necessary to fund it, at parity with private sector salaries.

The FDA (and the CDC and others) and pharma sectors trade people all the time. There is a revolving door between the two. Medicine isn't the only place this happens. It happens in telecomm, military, manufacturing, and so on.

We have experts at all levels. Those same experts may or may not have patriotic tendencies. They are placed for their knowledge of their respective industries. They may also have a financial ax to grind.

Is there a conflict of interest? Only if the appointee was appointed by the other party. I argue that the apparent conflict of interest is only surface level. In the US we don't have "capitalism", we have "crony capitalism" that is verging on technocracy (rule of The Science and unelected bureaucrats).

> The root of all government problems is "We trust you to make decisions that impact a large amount of monetary value, but also pay you less than the amount of money flowing through you, and also pay you less than private industry would be willing to.

The kinds of people who make those decisions are paid very well, and if they make it out without media incident, they are nearly always guaranteed a job in the industry they used to regulate.

> Is there a conflict of interest? Only if the appointee was appointed by the other party. I argue that the apparent conflict of interest is only surface level. In the US we don't have "capitalism", we have "crony capitalism" that is verging on technocracy (rule of The Science and unelected bureaucrats).

There is no such thing as capitalism separate from democracy, with a government that performs many functions.

It's not crony capitalism or technocracy. It's just normal capitalism in a democracy. Same way it has been since the founding of the United States.

> The kinds of people who make those decisions are paid very well

Are they? GS tops out at around $170k https://www.generalschedule.org/ . And S/ES at around $220k https://www.federalpay.org/ses/2022 .

That's a good salary. But it's not necessarily something I'd feel comfortable going to sleep with, knowing they had a finger on the scales of millions of dollars, if there weren't watchdog and mitigation measures in place.

> In the US we don't have "capitalism", we have "crony capitalism"

The real world system for which the term “capitalism” was coined, was, is, and always has been crony capitalism; the idea of a non-crony capitalism is a utopian fairy tale that was invented to justify real-world capitalism which has never resembled it.

The idea of "freedom" and inalienable rights are also utopian fairy tales. There's a reason the guys that wrote the Constitution called it "a more perfect union". We aren't perfect, by we may strive for that ideal.

> The idea of "freedom" and inalienable rights are also utopian fairy tales.

No, they are normative ideals, not fantastical models of how interactions do, or even could, work. Entirely different class of things, even if you disagree with them.

(It's true that people build utopian fairy tales out of them, such as the idea that a society observing certain complexes of multiple and conflicting rights without any tradeoff between them can exist. But the ideas of the rights themselves aren't the utopian fairy tales, they are just a value function.)

There are a wide range of options between startup bros and government. For example, in the US, a lot of electrical component standards and testing are managed by the UL, which is a nonprofit ngo.

Maybe something like "a UL for drug approval" might be worth a go.

The market for counterfeit and unregulated chargers and electronics on Amazon/Alibaba (most all of which are UL marked) and fires related to the above suggests that the UL doesn't really have any teeth.

It's possible that medical approvals would be less prone to this sidestepping of independent regulators, since much of the spending is proxied by insurance companies looking to maximize profits and minimize BS spending, but I have very little confidence that such a system would function.

There's also a wide range of things between the UL and FDA.

Besides, if it's counterfeit, then it's not actually UL marked, so I'm not sure what your argument is.

> Besides, if it's counterfeit, then it's not actually UL marked, so I'm not sure what your argument is.

Consumers can't tell the difference between devices that are fraudulently or legitimately marked with the UL logo, and the UL doesn't appear to be able to do anything about the prevalence of fraudulent uses of the UL mark.

Getting regulation "just right" is a complicated process, people differ in their risk tolerance, and it isn't clear to me at all that "more powers to X" is always the right answer.

I don’t sense hostility outside the typical vocal minority. Having straddled the FDA-regulated world and the libertarian-leaning internet cultures through the aughts and teens, my experience is that the internet libertarians are simply ignorant of how the FDA actually serves us. Pretty typically libertarian—freedom as long as nothing gets more dangerous. Kind of like rebellious children.

The fda is responsible for keeping hearing aids at insane prices my entire life. They serve as the gatekeepers for a cartel of once manufacturers, now IP holders (pure rent seekers,) who have successfully used the US government to exploit one of the most overlooked and vulnerable classes of people. Almost everyone loses hearing when they're older.

When you live with hearing loss, it leads to social isolation and embarrassing situations, depression, and all the usual attendant disasters in people's lives.

The hearing cartel has used their wealth to create a pseudomedicine so as to brand their salespeople as doctors, and infested almost every state with bureacrats who determine policy and direct licensing and enforcement.

Hearing aids that are priced at $5000 or more are produced at scale for less than $5 per unit. It'd be trivial to turn most modern headphones into hearing aid equivalent technology, but there is a regulatory moat surrounding real time audio enhancement that will cause the fda to shut down any attempt to augment regular hearing, let alone allow the hearing impaired the ability to operate what amounts to a stereo equalizer.

The fda does engage in legitimate business, but that's insufficient to justify the costs paid by people who get screwed when the FDA is exploited for profit.

I currently pay for "hearing aids as a service" and lose $200 a month for the privilege of hearing. I pay what amounts to extortion money for my disability. Because my loss is classified profound, none of the Obama era loosening of hearing aid restrictions help. It's lip service that acknowledges the problem but leaves 95% of it unsolved.

Libertarian shmibertarian, I think I'm entitled to not get specially fucked because my ears don't work. I think it's sick that I feel grateful that I can afford hearing as a service when it should be something covered by insurance, or something I can buy for the same cost as premium earbuds.

Government shouldn't be involved in hearing aids, except in the consumer protection arena. The fda has no business enabling the exploitation of disabled and vulnerable people, but hearing aids are just one area they happily strong-arm the public on behalf of cartels and industry lobbies.

I'm so sorry you're having such a hard time hearing and dealing with all this BS. Sending a firm but warm internet handshake your way. I don't have an answer to your issues and am here to listen if you need someone to vent to.

Why don't you just take a vacation to another country and buy a much cheaper hearing aid there?

This One example is not just due to the FDA, but the larger medical system. Yes they shouldn't cost that much and it is a cartel that overcharges, but also yes medical devices need regulation to prevent hucksters from exploiting people.

The FDA doesn't set prices. The cartels provide a product that works, which as far as the FDA is concerned, is all they care about. The FDA does not set prices.

As of 2017 there is already laws being changed to help lower prices and provide OTC hearing aids.

>Government shouldn't be involved in hearing aids, except in the consumer protection arena.

That is what they are involved with...

You seem to have demonized the FDA over one issue they don't really control and are now throwing the baby out with the bath water.

> Pretty typically libertarian—freedom as long as nothing gets more dangerous. Kind of like rebellious children.

Or, as this guy[1] put it, like house cats. “convinced of their fierce independence while utterly dependent on a system they don’t appreciate or understand.”

As a former Libertarian who luckily grew out of that phase, I love this analogy.

1: https://twitter.com/jspauldingphoto/status/14615069981183303...

Yea, that’s a good one!

HN had a huge sophomoric Randian streak years ago.. It seems to be maturing as I assume the users age.

It's easy to be Randian when you're young, don't have dependents, and are in good health.

One of the things I always liked about HN (even years ago HN) is that it seemed to feature a diversity of age ranges. Which brings some nice perspective.

On the other hand, countless lives would have been saved had we started using the Covid vaccine before the FDA got around to authorizing it. Those VC-funded startup bros at Moderna really could have moved a lot faster without the government’s interference.

Incredible, thank you for the live example of this mindset.

This is the epitome of survivorship bias. The Moderna vaccine could have just as well made a lot of people very very sick. There are countless examples of problematic medicines and vaccines which didn't get the scrutiny the COVID vaccines got (and continue to get) simply because not enough people were relevant for the studies and statistics are subsequently weaker.

We should all appreciate it went through the regulatory process (accelerated) to confirm it does not before injecting millions of people with it.

Regulations are written in blood, then the blood darkens and people forget why we have regulations.

Too often it seems it's blood of the lobbyist who slipped and fell on ice while carrying a suitcase full of benjamins.

Your quip is an easy one to make but there is very clearly no shortage of entities who peddle goods and services seeking, often successfully, to influence lawmaker so those goods and services are legally required despite the benefit to society being marginal if even measurable.

Regulations should be transparent, with link to original cases and deduction process documented. We are not telepaths.

You can look up any and all regulations online. Then you can read the transcripts of public comments regarding the regulations. You can find relevant court cases online. What else do you need?

Nobody does that now, for the most part, why would they do it if there were a hyperlink attached to the regulations themselves? Who actually reads the text of regulations in the general population? I have zero data, but I'm willing to bet it's virtually no one. Specialists with a vested interest sure do, and they will probably already know relevant cases or thought processes.

Edit: This was written in a very US-centric way, because it is in response to something originally about the FDA.

Finding of all that information requires a lot of time and dedication. In my country (Ukraine), a lot of information about law development process is available online. For example: http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_2?id=&pf3516=509... . It contains notes with explanation about why law need to be changed, but it hard to follow. Some information is available online, some in docx files, some in a random database, some on a video, some is not available at all.

The process is not fully transparent. It means that it's easy to create two laws, which are contradicting each other, or modify laws against their original purpose, etc., because it's hard to see consequences when the law is not transparent. For example, our ex-president Yanukovich just replaced Constitution on president site with an older version. Yes, it's online, but it took 2 years(!) until people noticed that and start to revolt.

In software development, we have test cases, which must be passed. In law development, we have nothing like that.

In my county, we read laws fairly often, because they are easy to get, but most of the time people prefer to read «commentary» — a book about law with comments and cases.

Well, they are? You just need to look them up. It seems you expect others to drip or force feed you these regulations or something.

If there was indeed a way to pull back the scope and power granted to the government I think a lot of us Americans would love to hear about it. The way it is, it seems like the US government is an unstoppable machine that will grow until it destroys itself.

I don’t think the American governments biggest problem is it’s scope and power: I think it’s biggest problem is inefficiency due to corruption (regulatory capture, etc). It seems to me that the biggest obstacle to fixing this is that many Americans see this as an inevitable character of government rather than something specific to their system, and thus spend their time trying to reduce government (ironically making it even less effective by hobbling it with silly restrictions) rather than fixing it into a well functioning system.

The two are interrelated — regulatory capture doesn’t make sense if there’s no power to capture. So one must first grow the size and power of government through other means, then capture/influence that power. This cycle has been going on for a long time.

One of the amendments is supposed to shield you from tyranny. But, going down a less risky path, I'd vote (no pun) for migration. My parents migrated away from a country that trades in humans to this day, in full view of the gov, and i can't be thankful enough.

Is that a recent push? I used to work for a company producing a diagnostic test, and it was being regulated as you said.

But what is the issue with that? Failures in diagnosis kill people very regularly. It should be regulated.

All you need is a conservative talking head to kickstart resistance to that as well, they just have to figure out a way of making money out of it.

>> to regulate diagnostic tests as medical devices.

Like MIR machines? Like blood labs? Like home pregnancy tests? Without the FDA's regulation of medicine we would quickly be back to snake oil and cocaine in everything. It is bad enough that drugs stores are allowed to sell water as a "homeopathic remedy". The snake oil people are out there waiting for deregulation.

>It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues

If they knew the extent of it they probably wouldn't.

I don't know where you're from but I'm sure the people there show equal apathy on some subjects.

> It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues

You're implying that all ~332 million Americans are a homogenous and single-minded mass. Please stop generalizing, it's not a good look.

Some of us realize it's straight up politics, but we have no power. It's not a choice, but a reality we live with.

That's actually why we're against it. Once they have the power it's basically impossible to recall it. There were many lines in the sand in the past and they keep being crossed.

Everyone who isn’t an HCP “surrenders” medical autonomy since not everyone pretends to know better than the experts.

HCPs love the idea of declaring autonomy as outdated, or problematic, or even better, an HCP behavior itself. Dream on.

It's funny how susceptible Americans are to medical misinformation. The FDA is a necessity.

Private companies also rely on the state for liability reasons as we just now saw with the vaccines. I believe overall this is a good idea to have high expectations for medical procedures as it does not inhibit progress.