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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

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.

DrAwdeOccarim 5y ago
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.
- ryandrake 5y ago
  > 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/1461506998118330374 https://twitter.com/jspauldingphoto/status/14615069981183303...
  - DrAwdeOccarim 5y ago
    Yea, that’s a good one!
- sjg007 5y ago
  HN had a huge sophomoric Randian streak years ago.. It seems to be maturing as I assume the users age.
  - ethbr0 5y ago
    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.
- robbedpeter 5y ago
  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.
  - searine 5y ago
    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.
admash 5y ago
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-part-by-the-companies-it-regulates-2/ 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-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical 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 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 https://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12073 (edit: more links)
- ethbr0 5y ago
  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.
  - all2 5y ago
    > 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.
4bpp 5y ago
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?
- InitialLastName 5y ago
  > 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.
- malfist 5y ago
  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.
School-Cotton 5y ago
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.
- neuronic 5y ago
  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.
inglor_cz 5y ago
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.
dnautics 5y ago
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.
- InitialLastName 5y ago
  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.
  - dnautics 5y ago
    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.
    - InitialLastName 5y ago
      > 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.

DrAwdeOccarim 5y ago

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.

ryandrake 5y ago
> 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/1461506998118330374 https://twitter.com/jspauldingphoto/status/14615069981183303...
- DrAwdeOccarim 5y ago
  Yea, that’s a good one!
sjg007 5y ago
HN had a huge sophomoric Randian streak years ago.. It seems to be maturing as I assume the users age.
- ethbr0 5y ago
  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.
robbedpeter 5y ago
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.
- searine 5y ago
  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.

admash 5y ago

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-part-by-the-companies-it-regulates-2/ 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-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical 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 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 https://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12073 (edit: more links)

ethbr0 5y ago
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.
- all2 5y ago
  > 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.

4bpp 5y ago

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?

InitialLastName 5y ago
> 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.
malfist 5y ago
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.

School-Cotton 5y ago

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.

neuronic 5y ago
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.

inglor_cz 5y ago

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.

dnautics 5y ago

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.

InitialLastName 5y ago
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.
- dnautics 5y ago
  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.
  - InitialLastName 5y ago
    > 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.