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?
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.
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.
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)
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.
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.
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.
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.
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.)
Maybe something like "a UL for drug approval" might be worth a go.
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.
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.
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.
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.
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...
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.
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.
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.
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.
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.
If only there hadn't been a major high profile collapse of a fraudulent diagnostic test company recently.