Who regulates the regulators? We need to go beyond review-and-approval(rootsofprogress.org)
rootsofprogress.org
Who regulates the regulators? We need to go beyond review-and-approval
https://rootsofprogress.org/against-review-and-approval
104 comments
> The regulator can still set legal penalties high enough to stop any innovation, if they want to.
A liability model has a couple of advantages despite this:
1. The regulator has some slack to not set penalties insanely high. As long as they're seen enforcing those penalties against someone periodically, and as long as the penalties sound like a big number to the general public, they can look like Stern Serious Regulators who are doing their jobs properly. The difference between a $5M fine and a $10M fine can have huge financial implications, but to the political circus those numbers are both roughly the same size, i.e. big. This allows the regulators to be more reasonable if they want to be.
2. Using liability rather than specific procedural rules lets the people closer to the ground decide how to most efficiently mitigate risk. Suppose that you run a factory, and sometimes people get injured by careless operation of a rotary saw. A naive regulatory approach might be to require that an additional person be watching whenever the rotary saw is in use. And that would probably help with safety somewhat, though at great cost. But if the regulator instead just requires workman's compensation payments to be made when someone gets hurt, then you can try to figure out a better way using your own knowledge of how your factory operates. (Historically, the adoption of workman's comp laws led to factories hiring engineers to make the equipment harder to accidentally misuse. That rotary saw, for example, would have had a cheap guard retrofitted -- and that would improve safety much more, for a much lower cost, than the "have an observer at all times" rule.)
A liability model has a couple of advantages despite this:
1. The regulator has some slack to not set penalties insanely high. As long as they're seen enforcing those penalties against someone periodically, and as long as the penalties sound like a big number to the general public, they can look like Stern Serious Regulators who are doing their jobs properly. The difference between a $5M fine and a $10M fine can have huge financial implications, but to the political circus those numbers are both roughly the same size, i.e. big. This allows the regulators to be more reasonable if they want to be.
2. Using liability rather than specific procedural rules lets the people closer to the ground decide how to most efficiently mitigate risk. Suppose that you run a factory, and sometimes people get injured by careless operation of a rotary saw. A naive regulatory approach might be to require that an additional person be watching whenever the rotary saw is in use. And that would probably help with safety somewhat, though at great cost. But if the regulator instead just requires workman's compensation payments to be made when someone gets hurt, then you can try to figure out a better way using your own knowledge of how your factory operates. (Historically, the adoption of workman's comp laws led to factories hiring engineers to make the equipment harder to accidentally misuse. That rotary saw, for example, would have had a cheap guard retrofitted -- and that would improve safety much more, for a much lower cost, than the "have an observer at all times" rule.)
The liability model has a big downside, though. Because sometimes people in charge are idiots, they ignore common sense and make risks. So they possibly get burned only when accident happens, which costs human health and lives.
Regulation is intended to prevent human harm by setting and enforcing a safety standard.
Regulation is intended to prevent human harm by setting and enforcing a safety standard.
That only applies to large rare risks. If a risk is common, anyone who ignores it quickly goes out of business from the liability, so anyone still in business is taking effective measures. If a risk is rare and has a low impact, ignoring it frequently is the right thing to do.
You're left with things like plane crashes, which have to be minimized even if they're already rare. But that kind of regulation is extraordinarily expensive, and then the same regulatory model gets applied where it isn't needed.
You're left with things like plane crashes, which have to be minimized even if they're already rare. But that kind of regulation is extraordinarily expensive, and then the same regulatory model gets applied where it isn't needed.
> You're left with things like plane crashes, which have to be minimized even if they're already rare.
I know we're all trying to be moderate here, but I'm not very good at that:
1) It is irrational. The cost-benefits of aircraft safety make no sense. Planes are held to a standard that we don't hold buses and trains to. We should strive to make rational decisions as a matter of policy.
2) There is no reason to think the US regulators are any good at what they are doing. As the thread root comment points out, the incentives are terrible. US industrial policy over my life time has consistently led to Asian growth and US stagnation in ways that were predictable. The US has banned most of the avenues that it could grow by, and coincidentally growth has largely stopped. Very similar story in Europe too, big focus on banning stuff (plus a bit of redistribution) and small focus on how to achieve more prosperity.
The US is dedicating the lives of countless smart people to taking a thing that was going to fly through the air like a bird and ... not changing the outcome much. They could have been doing something else that was more useful, like competing with China for telecoms leadership.
I don't think the evidence is there for this "having" to be minimised. The big picture looks a lot like people are behaving emotionally, that is sometimes leading to irrational decisions and those irrational decisions have added up to cause real harm. People should be more accepting of other people taking reasonable risk.
I know we're all trying to be moderate here, but I'm not very good at that:
1) It is irrational. The cost-benefits of aircraft safety make no sense. Planes are held to a standard that we don't hold buses and trains to. We should strive to make rational decisions as a matter of policy.
2) There is no reason to think the US regulators are any good at what they are doing. As the thread root comment points out, the incentives are terrible. US industrial policy over my life time has consistently led to Asian growth and US stagnation in ways that were predictable. The US has banned most of the avenues that it could grow by, and coincidentally growth has largely stopped. Very similar story in Europe too, big focus on banning stuff (plus a bit of redistribution) and small focus on how to achieve more prosperity.
The US is dedicating the lives of countless smart people to taking a thing that was going to fly through the air like a bird and ... not changing the outcome much. They could have been doing something else that was more useful, like competing with China for telecoms leadership.
I don't think the evidence is there for this "having" to be minimised. The big picture looks a lot like people are behaving emotionally, that is sometimes leading to irrational decisions and those irrational decisions have added up to cause real harm. People should be more accepting of other people taking reasonable risk.
> Planes are held to a standard that we don't hold buses and trains to. We should strive to make rational decisions as a matter of policy.
What are the poor ROI irrational decisions that the FAA makes on airline safety, how many lives do they save, and how many dollars do they add to the price of my ticket?
It's easy to say that things are not optimal. Let's say that's the case. What would you change?
> The US is dedicating the lives of countless smart people to taking a thing that was going to fly through the air like a bird and ... not changing the outcome much. They could have been doing something else that was more useful, like competing with China for telecoms leadership.
The US isn't a command economy, it can't redirect human effort like that, introducing subsidies into telecoms will distort the markets, and most of the country's intellect is wasted on financial innovation and adtech and middle management, anyways.
What are the poor ROI irrational decisions that the FAA makes on airline safety, how many lives do they save, and how many dollars do they add to the price of my ticket?
It's easy to say that things are not optimal. Let's say that's the case. What would you change?
> The US is dedicating the lives of countless smart people to taking a thing that was going to fly through the air like a bird and ... not changing the outcome much. They could have been doing something else that was more useful, like competing with China for telecoms leadership.
The US isn't a command economy, it can't redirect human effort like that, introducing subsidies into telecoms will distort the markets, and most of the country's intellect is wasted on financial innovation and adtech and middle management, anyways.
Thank you. We are nowhere close to the Pareto-efficient frontier for risk reduction. We could be safer, while sacrificing much less prosperity for that safety, if things were structured better.
(The optimal number of plane crashes is not zero, as the saying goes, and it’s probably more than we have now.)
(The optimal number of plane crashes is not zero, as the saying goes, and it’s probably more than we have now.)
Optimal by what measure? I don't know the saying.
You multiply the cost of prevention by the risk of a crash and see if it exceeds the cost of a crash.
Some plane crashes can be prevented with a $0.30 warning light. Preventing those plane crashes is optimal.
Some plane crashes can only be prevented by permanently grounding all planes, because they'll be caused by a confluence of improbable events. Trying to mitigate every implausible circumstance that could potentially lead to a crash is not optimal, even when some of them proceed to actually happen.
Some plane crashes can be prevented with a $0.30 warning light. Preventing those plane crashes is optimal.
Some plane crashes can only be prevented by permanently grounding all planes, because they'll be caused by a confluence of improbable events. Trying to mitigate every implausible circumstance that could potentially lead to a crash is not optimal, even when some of them proceed to actually happen.
Ah - so the measure is cost?
I suppose you could let the market decide, and just have airlines publish their failure rates, and more process means a higher ticket price. But it's a bit grisly.
I suppose you could let the market decide, and just have airlines publish their failure rates, and more process means a higher ticket price. But it's a bit grisly.
It is grisly, but the role the government has here is in setting reasonable liability numbers for a life, currently somewhere near $750K on average in the USA. On top of that there are putative penalties (sometimes including criminal) for negligence beyond current accepted standards.
> I suppose you could let the market decide
People think of the market as just involving the principles, but in practice you actually get a ecosystem of controls, between insurance companies, vendors setting standards beyond the normal risk of consumer litigation. The tradeoff is really one of how many specific procedures are specified top-down by government, or required by your insurance company (which may in-turn require something like third-party certification). In-practice plenty of the private regulatory regimes can provide just as much protection, or even better protection for the public as governmental review. They can also be worse. But they do tend to be nimbler, and also tend to leave more room for experiments and risk takers on the margin.
> I suppose you could let the market decide
People think of the market as just involving the principles, but in practice you actually get a ecosystem of controls, between insurance companies, vendors setting standards beyond the normal risk of consumer litigation. The tradeoff is really one of how many specific procedures are specified top-down by government, or required by your insurance company (which may in-turn require something like third-party certification). In-practice plenty of the private regulatory regimes can provide just as much protection, or even better protection for the public as governmental review. They can also be worse. But they do tend to be nimbler, and also tend to leave more room for experiments and risk takers on the margin.
I think it's worth keeping in mind that the Asian growth has often occurred due to their governments placing little value on human life and/or wellbeing. I'm not sure that's something that the US should aspire to emulate.
I'm not sure of a good way to have a middle ground between excessive regulation and devaluing human wellbeing. In that case, I'd rather that we err on the side of excessive regulation; especially since there are already powerful financial interests advocating for the other side.
I'm not sure of a good way to have a middle ground between excessive regulation and devaluing human wellbeing. In that case, I'd rather that we err on the side of excessive regulation; especially since there are already powerful financial interests advocating for the other side.
> especially since there are already powerful financial interests advocating for the other side.
There aren't actually powerful interests advocating for reduced safety. What they want is increased profits.
One way to do that is by eliminating safety measures to save costs, but liability for harm already removes that financial incentive because the cost of the liability should be greater than the cost of the mitigation in any case where the mitigation is cost effective.
Another way to increase profits is to impose "safety regulations" on smaller competitors so they go out of business and larger incumbents can raise prices. Powerful financial interests do not oppose this, they promote it.
There aren't actually powerful interests advocating for reduced safety. What they want is increased profits.
One way to do that is by eliminating safety measures to save costs, but liability for harm already removes that financial incentive because the cost of the liability should be greater than the cost of the mitigation in any case where the mitigation is cost effective.
Another way to increase profits is to impose "safety regulations" on smaller competitors so they go out of business and larger incumbents can raise prices. Powerful financial interests do not oppose this, they promote it.
1)
We were talking about aircraft a moment ago. Are low-status people known for their frequent flying? There are a lot of places where the problem clearly has nothing to do with valuing people - skilled workers aren't exactly treated like dirt, but they're often the ones that regulation cripples. I personally want to see nuclear scientists and engineers allowed to drop their standards to only 2-5x safer than current practice by other energy providers so that we can open up an economic boom in clean energy but obviously that ain't happening. Crippling safety standards continue to be the order of the day.
2)
We're living through the greatest expansion of living standards in the history of humanity. There has never been anything comparable to what has been happening over the last 70 years in Asia. Such an unprecedented rapid improvement that the English language doesn't have the words required to describe it.
There is something there that the US should aspire to emulate. I don't think we know what [0], but more effort should be going in to figuring that part out. If it was placing little value on human life then the US should do that, the results justify putting emotions aside.
How much is this "placing value on human life" worth anyway? https://en.wikipedia.org/wiki/List_of_tent_cities_in_the_Uni... paints a grim picture of how useful all this valuing is to the people on the ground. There is a force in politics that doesn't believe poor people have the capacity to improve themselves if given small economic opportunities. This blinding ignorance is leaving people worse off. In practice, 4% real growth in the economy would do much more for everyone than complaining that pro-growth policies seem kinda mean. Why should people care that they seem kinda mean? They work.
[0] I heard a cute theory that Maoism decimated the bureaucracy so much that it couldn't control China's economy.
We were talking about aircraft a moment ago. Are low-status people known for their frequent flying? There are a lot of places where the problem clearly has nothing to do with valuing people - skilled workers aren't exactly treated like dirt, but they're often the ones that regulation cripples. I personally want to see nuclear scientists and engineers allowed to drop their standards to only 2-5x safer than current practice by other energy providers so that we can open up an economic boom in clean energy but obviously that ain't happening. Crippling safety standards continue to be the order of the day.
2)
We're living through the greatest expansion of living standards in the history of humanity. There has never been anything comparable to what has been happening over the last 70 years in Asia. Such an unprecedented rapid improvement that the English language doesn't have the words required to describe it.
There is something there that the US should aspire to emulate. I don't think we know what [0], but more effort should be going in to figuring that part out. If it was placing little value on human life then the US should do that, the results justify putting emotions aside.
How much is this "placing value on human life" worth anyway? https://en.wikipedia.org/wiki/List_of_tent_cities_in_the_Uni... paints a grim picture of how useful all this valuing is to the people on the ground. There is a force in politics that doesn't believe poor people have the capacity to improve themselves if given small economic opportunities. This blinding ignorance is leaving people worse off. In practice, 4% real growth in the economy would do much more for everyone than complaining that pro-growth policies seem kinda mean. Why should people care that they seem kinda mean? They work.
[0] I heard a cute theory that Maoism decimated the bureaucracy so much that it couldn't control China's economy.
> Planes are held to a standard that we don't hold buses and trains to.
Or highway/pedestrian/cyclist safety, for that matter?
Or highway/pedestrian/cyclist safety, for that matter?
That is where mandatory liability insurance comes into play. Because the insurer will check... and if the people in charge are idiots, the insurance will charge them high premiums.
I am not sure how well this works in practice - but I think the idea has real merit.
I am not sure how well this works in practice - but I think the idea has real merit.
There is an issue with correlated vs uncorrelated risks. This is the reason that only the federal government can offer FDIC insurance for banks and disaster insurance in Florida. When banks fail, they tend to all fail at the same time and there is no insurer that could hold enough reserves to actually pay out if they all fail together. Private insurance can cover fire insurance for homes, but is unlikely to have enough in reserves to pay if a category 5 hurricane floods half the homes in Florida.
To make sure that I'm following, is what you are saying that the risk is that there's a big enough disaster that the insurance company(s) can't pay everything that's owed to those who have been harmed?
Correct. I'm saying that private insurance is good at insuring uncorrelated risks, like car wrecks, but usually, only the federal government can enable insuring correlated risks. Suggesting that mandatory liability insurance can a good policy alternative to regulation is correct, but if you are regulating something large enough with correlated risks, only the federal government can every really provide insurance. Banks pay FDIC insurance, and bank failures are usually covered by this, but it's pretty clear that the pool of money to save banks is backstopped by the federal government in case of a cascading failure.
Even for uncorrelated risk, if the payout event is bad enough, it can't be insured. For example, insurance on a nuclear plant is backstopped by the federal government, because no private insurer could ever really insure the worst case scenario.
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The usual hack for dealing with this is to require liability insurance. The insurer has incentives to set premiums at a level that reflect risk, along with reasonable contract conditions -- e.g. "Put guards on all your rotary saws, and yes we will be sending inspectors in to make sure they're being used properly."
(How is this different from an ordinary procedural regulator? Because the insurance market has competition, which means that the insurance companies aren't only trying to optimize for reducing risk -- they're trying to reduce risk efficiently. And if they're not very good at it, they can be outcompeted by someone who is.)
(How is this different from an ordinary procedural regulator? Because the insurance market has competition, which means that the insurance companies aren't only trying to optimize for reducing risk -- they're trying to reduce risk efficiently. And if they're not very good at it, they can be outcompeted by someone who is.)
Why would they check that the guards are in place when they can reject the claim after an accident happens because the guard wasn't in place?
Who regulates the insurers?
Who regulates the insurers?
Aren't all models vulnerable to "sometimes people in charge are idiots"?
> Because sometimes people in charge are idiots, they ignore common sense
This ignores that regulators are also people, with the same traits, but with no vested interest in making anything work.
This ignores that regulators are also people, with the same traits, but with no vested interest in making anything work.
Isn't #1 a downside? Regulators can impose penalties that sound like a big number but which corps just treat as a cost of doing business.
1. If the penalties are not insanely high, it just becomes another cost of doing business issue.
2. If you look at IRBs, how much do you think Scott Alexander is going to be able to pay for liability insurance? The review model does have some advantages.
2. If you look at IRBs, how much do you think Scott Alexander is going to be able to pay for liability insurance? The review model does have some advantages.
Making it part of the cost of doing business is precisely the point -- you allow business to go on when it passes a cost/benefit test, and the business tries to minimize that cost by taking safety measures. There's a middle ground between "basically nonexistent" and "insanely high".
The regulator has not only negative feedback when they fail, but also everyday pressure from lobby and interest groups, politicians, companies etc. to do their job faster and "cut the red tape". See for example the very public shaming of FAA by Elon Musk when while expecting launch licenses, tweeting 'sad Escobar in swing' memes etc. And that was just the visible tip of an iceberg of lobbying under the table.
So there is some sort of equilibrium forming, not necessarily an optimal one, but the ratchet does loosen occasionally. For example, FDA has famously succumbed to public pressure and reformed its procedures for drugs for terminal diseases so that patients who have nothing to lose can accept much riskier treatment trials, to speed up development for such drugs.
I say it's not an optimal equilibrium because nobody incentivizes for the common good. Politicians should, but they seldom do. For example, the nuclear industry would lobby and pressure for rapid approval of their existing traditional methods, but they would, as a whole, be very aggressive against a startup with an innovative design. What better way to kill such a competition than to call your regulator, lay out your 'concerns' and bash the startup with thick rulebook, even if those rules are not at all relevant for the new thing, they still have to comply for a 'fair' playing field.
So there is some sort of equilibrium forming, not necessarily an optimal one, but the ratchet does loosen occasionally. For example, FDA has famously succumbed to public pressure and reformed its procedures for drugs for terminal diseases so that patients who have nothing to lose can accept much riskier treatment trials, to speed up development for such drugs.
I say it's not an optimal equilibrium because nobody incentivizes for the common good. Politicians should, but they seldom do. For example, the nuclear industry would lobby and pressure for rapid approval of their existing traditional methods, but they would, as a whole, be very aggressive against a startup with an innovative design. What better way to kill such a competition than to call your regulator, lay out your 'concerns' and bash the startup with thick rulebook, even if those rules are not at all relevant for the new thing, they still have to comply for a 'fair' playing field.
> the feedback they get is either negative if there's a bad product released, or neutral if there is no terrible product released
Yeah, in some ideal world things would work like that.
On the real world, there is also an strong incentive not to block the profitability of any powerful person, and your paragraph applies only to powerless ones.
A couple of decades ago, there was a strong movement on the governments to measure and publicize the societal costs of the regulators procedures. Leaded by the US and Germany. But then we got the stupidification of politics, that stopped it completely.
Yeah, in some ideal world things would work like that.
On the real world, there is also an strong incentive not to block the profitability of any powerful person, and your paragraph applies only to powerless ones.
A couple of decades ago, there was a strong movement on the governments to measure and publicize the societal costs of the regulators procedures. Leaded by the US and Germany. But then we got the stupidification of politics, that stopped it completely.
The FDA is emphatically not a democratic institution. Who exactly do I vote for if I disagree with FDA policy? Can a civil service FDA employee be fired on the grounds of supporting a particular wildly unpopular policy?
I feel like thats a deliberate misreading of the parent comment.
Of course the FDA is not, itself, a democratic instution. But then neither is your local police department or NASA. The reason those institutions are accepted despite the lack of direct democratic accountability is because they are still situated within the larger democratic institution (the US government) and subject to oversight by those elected representatives.
If you hate the FDA your best bet is to lobby against it yourself (or help others that do). Its to much of an in-the-weeds issue for it to be a high priority for most lawmakers (unless maybe you live in a district with a lot of businesses regulated by FDA)
Of course the FDA is not, itself, a democratic instution. But then neither is your local police department or NASA. The reason those institutions are accepted despite the lack of direct democratic accountability is because they are still situated within the larger democratic institution (the US government) and subject to oversight by those elected representatives.
If you hate the FDA your best bet is to lobby against it yourself (or help others that do). Its to much of an in-the-weeds issue for it to be a high priority for most lawmakers (unless maybe you live in a district with a lot of businesses regulated by FDA)
> Groups like the FDA are democratic institutions
> deliberate misreading of the parent comment
> Of course the FDA is not, itself, a democratic instution.
Can't tell if doublethink or just motte-and-bailey.
> deliberate misreading of the parent comment
> Of course the FDA is not, itself, a democratic instution.
Can't tell if doublethink or just motte-and-bailey.
What are we supposed to get out of your comment, or is this supposed to just be an unvarnished sneer?
As readers we are supposed to learn that we are being misled. One hopes GP commenter would learn they cannot always get away with this sort of deception.
What, if anything, are we supposed to get out of your comment, which seems to question the value of critical reading?
What, if anything, are we supposed to get out of your comment, which seems to question the value of critical reading?
If you disagree, you can reply as to why you disagree, or you can silently disagree and move on. You've added no reasoning beyond the disagreement that slavboj brought up, only that you think it's not just wrong but... misleading? Of what? Why is it motte-and-bailey? Why would it be doublethink? What are you adding to the disagreement? rt4mn clearly states what they disagree about, namely their belief that a non-votable institution with democratic oversight is a democratic institution. All you're doing is sneering, you're not actually offering a reason for disagreement.
Sneering without reason brings the quality of discussion down on this site. Either substantively disagree or move on.
Sneering without reason brings the quality of discussion down on this site. Either substantively disagree or move on.
You could have just admitted that you're incapable of critical reading and moved on, instead of that wall of text.
Perhaps they misspoke, or perhaps they misunderstood, or perhaps their usage of the term is different then yours or mine. I understood them to mean it in the sense that the FDA holds democratic legitimacy by nature of its assistance as an org within the US government, which is by any reasonable definition a democratic institution.
The point is that its not really relevant to the point they are making, which is that the FDA as an institution has some weird incentives.
> motte-and-bailey.
I'm not familiar with this idiom so I cant say.
The point is that its not really relevant to the point they are making, which is that the FDA as an institution has some weird incentives.
> motte-and-bailey.
I'm not familiar with this idiom so I cant say.
Yeah, this is tough, because the obvious counterbalance to "only negative incentives" is to add some positive incentives but the US Patent and Trademark Office is an example of what can go wrong with positive incentives: there are loads of garbage patents on the book and one can't help but wonder if that's because the USPTO is financially incentivized to put them there.
I agree, though I am much less bothered by a proliferation of pointless patents than by a dearth of life-saving treatments.
Overall I agree, but I would say that is also an example of a negative incentive. A patent is restrictive and prevents innovation and competition in the market. So the patent office erring on the side of granting dubious patents is a restrictive policy same as the FDA erring on the side of not approving useful drugs.
I wonder if part of the issue is that FDA approval implies Medicare coverage, which is expensive. And so as a pragmatic matter the FDA slows approval for financial reasons. I don't know if it works at all like this, but the thought did come to mind.
> the feedback they get is either negative if there's a bad product released, or neutral if there is no terrible product released
Patient activists and drug companies lobby to make stonewalling approvals difficult.
Patient activists and drug companies lobby to make stonewalling approvals difficult.
Yeah, I'm pretty sure lobbying and hiring good lobbyists to the FDA is the only reason one of the projects I worked on saw the light of day. If our CEO hadn't already been through the process it would have died in De Novo.
If you think the regulators are Democratic I have this wonderful bridge I would like to sell you as an investment. I’m old enough to remember that dictators also hold elections with the same kind of results as the DC presidential election results.
Rather ironically, your naive perspective is precisely why “democracy” is a self-evidently failed system and there are clear arguments that it is also a counterproductive, intrinsically unsustainable, and self-defeating system.
Rather ironically, your naive perspective is precisely why “democracy” is a self-evidently failed system and there are clear arguments that it is also a counterproductive, intrinsically unsustainable, and self-defeating system.
Reminds me about the overnight pizza issue. I.e. the USDA claims pizza that's 2 hours old will kill you despite people eating old pizza all the time and probably no documented significant negative consequences.
https://news.ycombinator.com/item?id=26635856
https://news.ycombinator.com/item?id=26635856
> The FDA must have done something right
They have just as many issues as any other regulating body. There's many ingredients that are deemed safe in the US that the rest of the world has banned.
Every regulating body has been compromised thanks to late stage capitalism.
They have just as many issues as any other regulating body. There's many ingredients that are deemed safe in the US that the rest of the world has banned.
Every regulating body has been compromised thanks to late stage capitalism.
This is a curious extract - why didn't the author do the obvious research?
> "I don’t know much about what happened in the ~60 years since Kefauver–Harris [1962]. But today, I think there is good evidence, both quantitative and anecdotal, that the FDA has become too strict and conservative in its approvals, adding needless delay that holds back treatments from patients."
There have been endless scandals since then related to lax oversight and failures of the process, such as Merck's Vioxx scandal (FDA approval despite evidence of heart issues, only taken off the market after what $10 billion in sales???), the Pfizer-Bextra scandal ($2.3 billion settlement), a whole host of cancelled shady experiments, e.g.
> "A research scandal that led to the shutdown of 75 human experiments at the University of Oklahoma medical school in Tulsa has brought the departure of three top university officials and dismissal proceedings against a scientist."
https://www.latimes.com/archives/la-xpm-2000-jul-22-mn-57464...
Then there's the movement of clinical trials overseas by the likes of Pfizer to avoid FDA scrutiny, and resulting $7B lawsuits by Nigeria etc.
https://www.theguardian.com/world/2007/jun/05/health.healtha...
If people are going to write articles calling for less regulation of clinical trials in the USA by the FDA, they should at least try to inform themselves on recent history.
> "I don’t know much about what happened in the ~60 years since Kefauver–Harris [1962]. But today, I think there is good evidence, both quantitative and anecdotal, that the FDA has become too strict and conservative in its approvals, adding needless delay that holds back treatments from patients."
There have been endless scandals since then related to lax oversight and failures of the process, such as Merck's Vioxx scandal (FDA approval despite evidence of heart issues, only taken off the market after what $10 billion in sales???), the Pfizer-Bextra scandal ($2.3 billion settlement), a whole host of cancelled shady experiments, e.g.
> "A research scandal that led to the shutdown of 75 human experiments at the University of Oklahoma medical school in Tulsa has brought the departure of three top university officials and dismissal proceedings against a scientist."
https://www.latimes.com/archives/la-xpm-2000-jul-22-mn-57464...
Then there's the movement of clinical trials overseas by the likes of Pfizer to avoid FDA scrutiny, and resulting $7B lawsuits by Nigeria etc.
https://www.theguardian.com/world/2007/jun/05/health.healtha...
If people are going to write articles calling for less regulation of clinical trials in the USA by the FDA, they should at least try to inform themselves on recent history.
The presence of a handful of scandals with huge settlements does not need that we need more FDA.
We need less. Much less. At the very least we need to separate the concept of it being legal for doctors to prescribe a drug and mandatory for insurance to pay for a drug.
Right this minute, hundreds or thousands people are actively suffering and dying from rare diseases because it's ludicrously expensive to bring new medicines to market. We place blame - we file lawsuits - on someone who sells a drug that doesn't work or that causes harmful side effects, but we sag our shoulders and shake our fist at the uncaring universe when someone dies of a disease that wasn't worth $200,000,000 to force a guaranteed-safe treatment through FDA approval.
A medical review and approval process that must never, ever allow a single bad outcome through on pain of terrible, multi-billion-dollar scandals is guaranteed to cause bad outcomes, because not allowing good things to be approved is a bad outcome.
We need less. Much less. At the very least we need to separate the concept of it being legal for doctors to prescribe a drug and mandatory for insurance to pay for a drug.
Right this minute, hundreds or thousands people are actively suffering and dying from rare diseases because it's ludicrously expensive to bring new medicines to market. We place blame - we file lawsuits - on someone who sells a drug that doesn't work or that causes harmful side effects, but we sag our shoulders and shake our fist at the uncaring universe when someone dies of a disease that wasn't worth $200,000,000 to force a guaranteed-safe treatment through FDA approval.
A medical review and approval process that must never, ever allow a single bad outcome through on pain of terrible, multi-billion-dollar scandals is guaranteed to cause bad outcomes, because not allowing good things to be approved is a bad outcome.
There's an easy fix for these rare disease cases, but it's not one the pharmaceutical industry likes - open source drug development with clinical trials run by research agencies themselves.
This would mean such drugs would not be exclusively licensed by any private entity, but instead could be manufactured and distributed by anyone that met quality standards, greatly reducing prices for consumers. See Linux etc.
This would mean such drugs would not be exclusively licensed by any private entity, but instead could be manufactured and distributed by anyone that met quality standards, greatly reducing prices for consumers. See Linux etc.
This Scott Alexander essay says that the FDA is too strict on some things and not strict enough on others, which is probably right: https://astralcodexten.substack.com/p/adumbrations-of-aducan...
they hired a new staff of administrators to wield the real power. These administrators had never done research themselves, had no particular interest in research, and their entire career track had been created ex nihilo to make sure nobody got sued.
Really in many cases it's been co-opted for special interests for the sake of rent seeking. It's just layers of problems at this point.
So, summarizing the timeline here:
Bad things happened.
Review-and-approve regulation happened, things improved.
Another bad thing happened, at a much lower scale.
Regulators cracked down, professional admins replaced experts, things got buried in red tape.
The author argues against review-and-approve but they don't present a better alternative than that first review-and-approve. They mention, but don't really endorse, liability law models. But today's adversarial legal model in the US is also slow, expensive, and results in tons of cover-your-ass legalese at large places.
The "ratcheting up" of the regulation enforcement seems like the much bigger problem here than an "review and approve" model itself. The need to look like you're doing anything to try to prevent bad things from ever happening.
We don't see that everywhere - we enforce speeding and reckless driving laws, but sometimes people still die from traffic incidents caused by those. The reaction hasn't been to put ten times as many cop cars on the road, or ubiquitous speed cameras. We did put in cameras for red lights, but those lost a lot of momentum and were pulled back in some places instead of rapidly turning into constant monitoring of everything about driving.
So is the problem just that politicians don't relate or understand something like a medical study as well as they do driving, and don't understand the tradeoffs and burden required to try to make sure nothing went wrong, ever? If anything, I'd expect that to result in industry lobbyists pushing deregulation to have a much easier go of it than they have. So I don't get it.
Bad things happened.
Review-and-approve regulation happened, things improved.
Another bad thing happened, at a much lower scale.
Regulators cracked down, professional admins replaced experts, things got buried in red tape.
The author argues against review-and-approve but they don't present a better alternative than that first review-and-approve. They mention, but don't really endorse, liability law models. But today's adversarial legal model in the US is also slow, expensive, and results in tons of cover-your-ass legalese at large places.
The "ratcheting up" of the regulation enforcement seems like the much bigger problem here than an "review and approve" model itself. The need to look like you're doing anything to try to prevent bad things from ever happening.
We don't see that everywhere - we enforce speeding and reckless driving laws, but sometimes people still die from traffic incidents caused by those. The reaction hasn't been to put ten times as many cop cars on the road, or ubiquitous speed cameras. We did put in cameras for red lights, but those lost a lot of momentum and were pulled back in some places instead of rapidly turning into constant monitoring of everything about driving.
So is the problem just that politicians don't relate or understand something like a medical study as well as they do driving, and don't understand the tradeoffs and burden required to try to make sure nothing went wrong, ever? If anything, I'd expect that to result in industry lobbyists pushing deregulation to have a much easier go of it than they have. So I don't get it.
I think a lot of it is timing, bias towards the status quo, and how much immediate tangible benefit there is to the consumer. Take the example of electricity. It's quite easy to build a coal power plant and extremely difficult to build a nuclear power plant even though the former is much dirtier and more dangerous than the latter. The reason is that when coal power plants were invented, the alternative was no electricity. It would have been politically impossible to make it difficult to build them or shut down existing plants. People would have rioted. Politicians would have been voted out. There were power plant accidents, horrific pollution, tens of thousands of deaths from coal mining disasters, but nobody is going to go back to not having power, so this was just accepted and became the status quo.
Then when nuclear power is invented and plants are built, the alternative is coal, not going without power. So when there are nuclear accidents, the regulators can go nuts and shut down plants, and prevent new ones from being built. Consumers don't care that much about what the source of their electricity is, and coal is the status quo, so no politician loses their seat for going back to it.
If nuclear power had been invented first, it and all its problems would have just been accepted as the cost of having electricity instead, and it would be extremely difficult to build coal plants.
Then when nuclear power is invented and plants are built, the alternative is coal, not going without power. So when there are nuclear accidents, the regulators can go nuts and shut down plants, and prevent new ones from being built. Consumers don't care that much about what the source of their electricity is, and coal is the status quo, so no politician loses their seat for going back to it.
If nuclear power had been invented first, it and all its problems would have just been accepted as the cost of having electricity instead, and it would be extremely difficult to build coal plants.
> They mention, but don't really endorse, liability law models. But today's adversarial legal model in the US is also slow, expensive, and results in tons of cover-your-ass legalese at large places.
They allude to no-fault workman's compensation laws, discussed at greater length in this excellent article:
https://rootsofprogress.org/history-of-factory-safety
The trick there was to take the liability out of the adversarial court system, by not requiring the injured party to prove that the employer was at fault -- only that they got injured somehow. And it worked much more reliably, with less ass-covering and less overhead, than the previous tort-based model.
They allude to no-fault workman's compensation laws, discussed at greater length in this excellent article:
https://rootsofprogress.org/history-of-factory-safety
The trick there was to take the liability out of the adversarial court system, by not requiring the injured party to prove that the employer was at fault -- only that they got injured somehow. And it worked much more reliably, with less ass-covering and less overhead, than the previous tort-based model.
> So is the problem just that politicians don't relate or understand something like a medical study as well as they do driving, and don't understand the tradeoffs and burden required to try to make sure nothing went wrong, ever? If anything, I'd expect that to result in industry lobbyists pushing deregulation to have a much easier go of it than they have. So I don't get it.
Yes, it's that politicians and importantly members of the public don't relate. Driving is so ubiquitous in the US that almost everyone does it. Almost everyone with the ability to decide things in America or who has the time to lobby for something has been a driver and can empathize with a driver who was doing their best but encountered something unexpected on the road and ended up in a crash (note my usage of passive language, specifically to build up this frame-of-mind, even though in reality it isn't like this.)
The average American doesn't see themselves as the creators of new drugs nor do they see themselves as airline pilots. Even if the harms American perpetuate via driving are actually worse than the harms of the other two, without the ability to empathize as the creator of a drug or a commercial airline pilot, they're much more likely to favor heavy censure for wrongdoing for something they see as being done by someone else. It's a case of "Look grandma was trying her best when she accidentally crashed into the kid" vs "Those elites at Johns Hopkins trying to pull the wool over our eyes." The less likely the average American is to work a job, the more likely the average American is at heavily regulating that job.
It's a big problem with American regulations because everyday harms are swept under the rug while rare harms perpetrated by a minority are dealt with harshly.
Yes, it's that politicians and importantly members of the public don't relate. Driving is so ubiquitous in the US that almost everyone does it. Almost everyone with the ability to decide things in America or who has the time to lobby for something has been a driver and can empathize with a driver who was doing their best but encountered something unexpected on the road and ended up in a crash (note my usage of passive language, specifically to build up this frame-of-mind, even though in reality it isn't like this.)
The average American doesn't see themselves as the creators of new drugs nor do they see themselves as airline pilots. Even if the harms American perpetuate via driving are actually worse than the harms of the other two, without the ability to empathize as the creator of a drug or a commercial airline pilot, they're much more likely to favor heavy censure for wrongdoing for something they see as being done by someone else. It's a case of "Look grandma was trying her best when she accidentally crashed into the kid" vs "Those elites at Johns Hopkins trying to pull the wool over our eyes." The less likely the average American is to work a job, the more likely the average American is at heavily regulating that job.
It's a big problem with American regulations because everyday harms are swept under the rug while rare harms perpetrated by a minority are dealt with harshly.
Perhaps the difference with traffic regulations is that both the benefits and drawbacks of regulation are experienced directly by many regular people. Whereas the benefits and drawbacks of corporate regulation are most directly experienced by the upper levels of corporate leadership.
Granted, even then I'm not sure what the solution is. (Well, at least assuming that employee owned corporations are mostly a non-starter in the US.)
Granted, even then I'm not sure what the solution is. (Well, at least assuming that employee owned corporations are mostly a non-starter in the US.)
I find the arguments selective and entirely unconvincing.
The examples he brings up are all selected to elicit an emotional response while not really investigating how regulations have prevented significant number of deaths (this is admittedly difficult).
Several of the arguments and sources given make only sense at first glance, e.g. the argument about the FDA would be more convincing if not for the fact that pharmaceuticals still spend as much on marketing (that's the conservative estimate) as on R&D (they even argue that giving away free samples should not count as marketing I kid you not https://www.raps.org/news-and-articles/news-articles/2019/7/...).
The arguments that anesthesists give a good example for a liability model because of some improvements made in the 90s, maybe makes sense from a purely US point of view. The question is (and this was not investigated in the source) how did the improvements compare in countries without the same liability but regulations. So would (or have) the same improvements being made with regulation.
Similay he brings up nuclear power and argues that liability would be a better model. Apart from the fact that the cost of nuclear vs renewables is not primarily driven by regulation (there was an analysis here on HN a couple of months ago, which I can't find on mobile atm), liability would kill nuclear in its tracks because no insurance would or could cover the potential cost a nuclear disaster.
Finally, why not talk about the FCC, a regulation agency which has made flying the safest mode of travel in the world. In fact if the aviation industry was as lax as the medical we had planes falling out of the sky multiple times a day. They only recently come under flag, because they have been dropping the ball because they got too cosy with the industry. Largely in the desire to speed up the process, which also refutes the argument that there is not counter regulation pressure.
Another example of pressure to reduce regulations are financial regulations. Their reduction arguably gave us (or contributed) to the GFC.
Several of the arguments and sources given make only sense at first glance, e.g. the argument about the FDA would be more convincing if not for the fact that pharmaceuticals still spend as much on marketing (that's the conservative estimate) as on R&D (they even argue that giving away free samples should not count as marketing I kid you not https://www.raps.org/news-and-articles/news-articles/2019/7/...).
The arguments that anesthesists give a good example for a liability model because of some improvements made in the 90s, maybe makes sense from a purely US point of view. The question is (and this was not investigated in the source) how did the improvements compare in countries without the same liability but regulations. So would (or have) the same improvements being made with regulation.
Similay he brings up nuclear power and argues that liability would be a better model. Apart from the fact that the cost of nuclear vs renewables is not primarily driven by regulation (there was an analysis here on HN a couple of months ago, which I can't find on mobile atm), liability would kill nuclear in its tracks because no insurance would or could cover the potential cost a nuclear disaster.
Finally, why not talk about the FCC, a regulation agency which has made flying the safest mode of travel in the world. In fact if the aviation industry was as lax as the medical we had planes falling out of the sky multiple times a day. They only recently come under flag, because they have been dropping the ball because they got too cosy with the industry. Largely in the desire to speed up the process, which also refutes the argument that there is not counter regulation pressure.
Another example of pressure to reduce regulations are financial regulations. Their reduction arguably gave us (or contributed) to the GFC.
You're so focused on reducing risk from the treatments/procedures themselves that you're not looking at the risks caused by the diseases that the treatments/procedures are not able to cure because they have not innovated fast enough.
This is the classic pro-centralization bias.
Cancer and heart treatment are still in the stone age, with whole-body toxification in chemotherapy, and cutting open people's chest for open heart surgery, still being mainstay treatments.
Costs are also not declining, making cutting edge treatments unaffordable and inaccessible.
Compare to less regulated sectors, where quality has improved orders of magnitude while costs have massively declined, and it's clear that medicine/pharmaceuticals are underpeforming.
This is the classic pro-centralization bias.
Cancer and heart treatment are still in the stone age, with whole-body toxification in chemotherapy, and cutting open people's chest for open heart surgery, still being mainstay treatments.
Costs are also not declining, making cutting edge treatments unaffordable and inaccessible.
Compare to less regulated sectors, where quality has improved orders of magnitude while costs have massively declined, and it's clear that medicine/pharmaceuticals are underpeforming.
> FCC, a regulation agency which has made flying the safest mode of travel in the world
FCC or FAA?
FCC or FAA?
Another aspect of this is that a lot of regulation doesn't really work, it gets corrupted or bloated in numerous ways because it might help but actually doesn't. The separation between people doing the thing and those overseeing it leads to ineffective regulation that ends up not actually saving lives and also potentially costing a lot of manual time to adhere too.
I am not sure liability insurance is necessarily the complete answer. I think widening of criminal charges for breaching regulation should absolutely be pursued alongside liability for harms to humanity, there should be a basic duty of care to the the planet and its inhabitants and to the people that work for you that they are not harmed by your endeavours. We can't just continue allowing wage theft all the way up to mass destruction to the environment and treating it like its just a small fine that is necessary to resolve it. The system needs to expel those willing to take minor risk of getting caught for the large personal gain.
I am not sure liability insurance is necessarily the complete answer. I think widening of criminal charges for breaching regulation should absolutely be pursued alongside liability for harms to humanity, there should be a basic duty of care to the the planet and its inhabitants and to the people that work for you that they are not harmed by your endeavours. We can't just continue allowing wage theft all the way up to mass destruction to the environment and treating it like its just a small fine that is necessary to resolve it. The system needs to expel those willing to take minor risk of getting caught for the large personal gain.
I see this all the time but it seems every time we go through a round of regulation trimming based on that premise we see the industry in question suffering issues within a couple years, and the cycle seems to just keep getting tighter.
The 90s/early 00s cut back banking regulation and then we had the 08 crash. Trump rolled back some rail regulations and now we've got serious incidents happening there. Of course businesses hate the regulations they're generally preventing profitable but very risky behaviors with externalities beyond the business that's taking the risk.
Combine that with Supreme Court decisions that have limited courts abilities to punish companies when they do mess up by limiting things like punitive damages and the picture gets bleak for any option other than up front, very paperwork heavy regulation.
If we could trust businesses to actually follow rules and not take disastrous short cuts to make a buck maybe we could have a less heavy handed regulatory system but time and time again shows voluntary compliance or self regulation isn't a viable option.
The 90s/early 00s cut back banking regulation and then we had the 08 crash. Trump rolled back some rail regulations and now we've got serious incidents happening there. Of course businesses hate the regulations they're generally preventing profitable but very risky behaviors with externalities beyond the business that's taking the risk.
Combine that with Supreme Court decisions that have limited courts abilities to punish companies when they do mess up by limiting things like punitive damages and the picture gets bleak for any option other than up front, very paperwork heavy regulation.
If we could trust businesses to actually follow rules and not take disastrous short cuts to make a buck maybe we could have a less heavy handed regulatory system but time and time again shows voluntary compliance or self regulation isn't a viable option.
> The 90s/early 00s cut back banking regulation and then we had the 08 crash.
Little to no evidence that the deregulation was the cause
> Trump rolled back some rail regulations and now we've got serious incidents happening there.
Derailments have increased recently but are still lower than they were in 2000.
Little to no evidence that the deregulation was the cause
> Trump rolled back some rail regulations and now we've got serious incidents happening there.
Derailments have increased recently but are still lower than they were in 2000.
> Derailments have increased recently but are still lower than they were in 2000.
So we've regressed approximately two entire decades in rail safety. I'd say that's an L...
So we've regressed approximately two entire decades in rail safety. I'd say that's an L...
We don't have a succinct term that captures the real risks of over-regulation (see the Sapir-Whorf hypothesis). I recommend the term "metarisk" to describe the risks that come from being too risk averse. As in: you are too focused on the risk and don't understand the metarisk you are creating.
More generally, the public and journalists only seem to have the intellectual capacity for first-order thinking, not second-order (not speaking of individuals, per se, just the emergent dynamics).
I would love to see an experiment that creates an agency that regulates other agencies, which has the following mandate: require all agencies to demonstrate that the all proposed regulations and regulatory enforcement has an outcome that is optimally beneficial for society. The agency would have the power to fire employees of other agencies and to disband and reconstitute entire agencies.
Don't get hung up on defining optimality, the metaregulators' real job is just to have the regulators think twice before letting their block-everything reflex kick in.
More generally, the public and journalists only seem to have the intellectual capacity for first-order thinking, not second-order (not speaking of individuals, per se, just the emergent dynamics).
I would love to see an experiment that creates an agency that regulates other agencies, which has the following mandate: require all agencies to demonstrate that the all proposed regulations and regulatory enforcement has an outcome that is optimally beneficial for society. The agency would have the power to fire employees of other agencies and to disband and reconstitute entire agencies.
Don't get hung up on defining optimality, the metaregulators' real job is just to have the regulators think twice before letting their block-everything reflex kick in.
I think the idea of MANDARORY liability insurance against regulatory fines is very interesting.
The insurer is motivated to incentivise effective risk-reduction behaviour - the government only has to define the penalties.
The insurer is motivated to incentivise effective risk-reduction behaviour - the government only has to define the penalties.
Or the insurers are incentivized to lobby for regulation reduction or, worse, cover-ups
It’s true. But the current state is also untenable. People are dying that could be saved if we weren’t making medical trials and environmental review so costly.
People are quick to point out the deficiencies of Adam Smith's invisible hand.
But then turn around and appeal to an equally dubious deity.
But then turn around and appeal to an equally dubious deity.
Some real Plato Guardians vibe from all this. Maybe AI will someday in fact be the objective guardians we need (say, if all parties verify the code is objective ex ante). I think men are too prone to corruption and bias for truly bias-free human regulators to exist.
It's all just a mirage. You can never avoid the Iron Law of Oligarchy: it doesn't matter what system you think you have - monarchy, democracy, anarchy, dictatorship; what you have always amounts to rule by oligarchs
The problem with hierarchies like "regulators" is that there is never a bidirectional feedback loop. The people who are being regulated should also be able to negatively review poor regulators.
FWIW what I've seen from IRBs isn't so much risk aversion as institutional protectionism where they seem to do a good job of keeping things quiet when stuff goes wrong.
It's not just regulators.
It's bureaucrats across a whole range of activities, or lack of activity thereof.
There was an article a while back on HN about the "Bureaucratic Failure Mode" that was worthwhile to look at.
It's bureaucrats across a whole range of activities, or lack of activity thereof.
There was an article a while back on HN about the "Bureaucratic Failure Mode" that was worthwhile to look at.
Regulations really don't work when you're dealing with adults. Anti-social behaviors cannot be regulated. That's actually the point of being anti-social.
Throughout history, every time you start to count on regulations, the whole thing falls apart pretty quickly. LOOK ELSEWHERE. We didn't have this much regulations 30 years ago and things were great.
Throughout history, every time you start to count on regulations, the whole thing falls apart pretty quickly. LOOK ELSEWHERE. We didn't have this much regulations 30 years ago and things were great.
I don’t know what to say. 1993 was definitely not better than 2023.
The world moves forwards, three steps forward and two steps back. Human rights have progressed enormously since 1993 and that’s largely due to regulation. Deaths from smoking have been reduced. Deaths from car accidents have declined. Incredible, life changing drugs have been developed. And, of course, things have become worse in other ways. Wealth inequality being a very big one.
Things might have been great if you were healthy and wealthy in 1993, but I’d definitely not want to go back there.
The world moves forwards, three steps forward and two steps back. Human rights have progressed enormously since 1993 and that’s largely due to regulation. Deaths from smoking have been reduced. Deaths from car accidents have declined. Incredible, life changing drugs have been developed. And, of course, things have become worse in other ways. Wealth inequality being a very big one.
Things might have been great if you were healthy and wealthy in 1993, but I’d definitely not want to go back there.
Well you have a good point, I'll give you that.
Although you don't seem to understand the real reason you're living a "better" life: Someone (you or others) pays for it. Lives don't get better by regulation, they get better by hard work. The real reason smoking are less is because nice hard working people reach a consensus that smoking is bad. Not a genius that imposes regulation on smoking. Actually, if you don't offer alternatives for a nicotine addict (like a good life), regulation only makes them resentful and anti-social. So get your priorities straight.
Although you don't seem to understand the real reason you're living a "better" life: Someone (you or others) pays for it. Lives don't get better by regulation, they get better by hard work. The real reason smoking are less is because nice hard working people reach a consensus that smoking is bad. Not a genius that imposes regulation on smoking. Actually, if you don't offer alternatives for a nicotine addict (like a good life), regulation only makes them resentful and anti-social. So get your priorities straight.
This makes no sense to me. Lives get better through many factors. Better knowledge. Better medicine. Better education. Better products. Greater shared wealth. And, ideally, better regulation.
I do not vote for governments who allow companies to sell dangerous goods to unsuspecting people for profit.
By all means let them sell dangerous products to informed people who know and accept the risks (I’m looking at you, Blast Aqua Park :). But regulation is needed because shitty companies do shitty things to people who don’t deserve it, don’t expect it, and are “encouraged” to have no idea about it.
There are always going to be bad actors who make the world worse. And, because of those people, we need regulation.
I do not vote for governments who allow companies to sell dangerous goods to unsuspecting people for profit.
By all means let them sell dangerous products to informed people who know and accept the risks (I’m looking at you, Blast Aqua Park :). But regulation is needed because shitty companies do shitty things to people who don’t deserve it, don’t expect it, and are “encouraged” to have no idea about it.
There are always going to be bad actors who make the world worse. And, because of those people, we need regulation.
Great, now I got flagged. Someone is trying to regulate my words, because they feel uncomfortable. Funny I just predicted exactly that. The comment became recursive. Just like the self-fulfilling recursive personality structure of a narcissist.
For the record, it wasn’t me.
Irony alert.
Irony alert.
Not getting it.
It's not about you anyway.
> Lives get better through many factors. Better knowledge. Better medicine. Better education. Better products. Greater shared wealth. And, ideally, better regulation.
Who pays for that? You don't sound like you're an active participant in producing any of that stuff. You sound like you're just an advocate for "more" regulation. How does that help? Don't you agree that bad regulations do more damage than a single bad actor? Like in Soviet Union?
Or it could just be that you're the bad actor in disguise, or you don't realise it yourself. Don't get me wrong here, but your mindset sounds like that of a young child, who wants to control everything, by "regulating" others' behaviour.
Who pays for that? You don't sound like you're an active participant in producing any of that stuff. You sound like you're just an advocate for "more" regulation. How does that help? Don't you agree that bad regulations do more damage than a single bad actor? Like in Soviet Union?
Or it could just be that you're the bad actor in disguise, or you don't realise it yourself. Don't get me wrong here, but your mindset sounds like that of a young child, who wants to control everything, by "regulating" others' behaviour.
I'm not sure that things were really great 30 years ago with respect to things that have been regulated. For example, greenhouse gas emissions and discrimination against LGBTQ people were both much worse than they are now. Just slightly more than 30 years ago (33 years) we didn't have the Americans with Disabilities Act so it was much more difficult for disabled people to get accommodations.
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Do we just need better regulators? We could increase pay and hire larger regulatory staffs to move faster. It seems to work for Singapore.
This is a problem not only for regulators, but pretty much any profession we might want to improve.
Our labor pool is vast, but fixed. There is some fungibility among the individual workers... a welder can be re-trained as a teacher, or a miner can be re-trained to become a web developer. But it isn't perfectly fungible, the 45 yr taxi cab driver can't re-train to be an oncologist, and he certainly can't re-train to be a pharmaceutical engineer.
We might even say that they're not even mostly fungible... not for the professions we really want the most.
So how many "better regulators" do you need? Do you need two more, nationwide? We could probably find those. Do you need 24? A little more difficult, but as long as you are willing to wait 18 months or so, doable.
Do you need 300? 600? 800? Exactly how many at the FDA have to be superior regulators there? Worse still, even if the number is low...
What incentivizes someone who could be the superior regulator, but has chosen to be whatever-else-it-is-that-they-are? Do we need to offer more money? How much more? Million dollar salaries for one or two is feasible, but not for 800. Worse, even if we can afford it, offering that much money doesn't just attract them, it attracts many more inferior regulators.
Can you tell the difference? If three people show up for the $500,000/year regulator job, and two are schmoozing assholes, and the third is hyper-competent, what hiring system can you devise to reliably pass on the two and pick the other?
If the signal-to-noise ratio is too high there, it can likely overwhelm even a good hiring system.
And if it's bad for regulators, then this is simply a losing strategy for jobs like teachers, where we don't need a few dozen or a few dozen "better teachers", but hundreds of thousand of them. Police, etc.
Our labor pool is vast, but fixed. There is some fungibility among the individual workers... a welder can be re-trained as a teacher, or a miner can be re-trained to become a web developer. But it isn't perfectly fungible, the 45 yr taxi cab driver can't re-train to be an oncologist, and he certainly can't re-train to be a pharmaceutical engineer.
We might even say that they're not even mostly fungible... not for the professions we really want the most.
So how many "better regulators" do you need? Do you need two more, nationwide? We could probably find those. Do you need 24? A little more difficult, but as long as you are willing to wait 18 months or so, doable.
Do you need 300? 600? 800? Exactly how many at the FDA have to be superior regulators there? Worse still, even if the number is low...
What incentivizes someone who could be the superior regulator, but has chosen to be whatever-else-it-is-that-they-are? Do we need to offer more money? How much more? Million dollar salaries for one or two is feasible, but not for 800. Worse, even if we can afford it, offering that much money doesn't just attract them, it attracts many more inferior regulators.
Can you tell the difference? If three people show up for the $500,000/year regulator job, and two are schmoozing assholes, and the third is hyper-competent, what hiring system can you devise to reliably pass on the two and pick the other?
If the signal-to-noise ratio is too high there, it can likely overwhelm even a good hiring system.
And if it's bad for regulators, then this is simply a losing strategy for jobs like teachers, where we don't need a few dozen or a few dozen "better teachers", but hundreds of thousand of them. Police, etc.
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Even as the article states, the problem is the risk-aversion of private actors to regulation. I can assure you, the scientists are happy to have the administrators handle regulatory affairs. To get approvals, administrators do the comparative analysis to show that a similar risk was accepted with similar constraints.
The real problem is the advantage this gives to repeat players. Then innovators have to sell out to the majors before market validation, so there's been little significant change in the identity of the key players, even though there have been huge (finance-driven) changes in organizational and market structures (with wider profit margins).
It also amplifies first-mover advantage. Not only do first movers capture customers, they set the regulatory standards others have to beat. If they are a key technology (like Illumina's NGS short-read sequencing), it's a perfect set-up for the monopoly to tie sale of one product to another (e.g., the one-time hardware to ongoing reagents or software services). This is amplified by the privacy of the regulatory submissions.
How can it be changed? It can't. Big pharma is a trillion-dollar golden egg is a nest of the FDA's making, and no rational humanistic discourse or broad-based health-care financing issues are going to dislodge those investments.
The best we can hope for is to keep the profiteering reasonably discreet. By being somewhat unpredictable, the FDA gives each administration leverage to extract some concessions for each generation.
The real problem is the advantage this gives to repeat players. Then innovators have to sell out to the majors before market validation, so there's been little significant change in the identity of the key players, even though there have been huge (finance-driven) changes in organizational and market structures (with wider profit margins).
It also amplifies first-mover advantage. Not only do first movers capture customers, they set the regulatory standards others have to beat. If they are a key technology (like Illumina's NGS short-read sequencing), it's a perfect set-up for the monopoly to tie sale of one product to another (e.g., the one-time hardware to ongoing reagents or software services). This is amplified by the privacy of the regulatory submissions.
How can it be changed? It can't. Big pharma is a trillion-dollar golden egg is a nest of the FDA's making, and no rational humanistic discourse or broad-based health-care financing issues are going to dislodge those investments.
The best we can hope for is to keep the profiteering reasonably discreet. By being somewhat unpredictable, the FDA gives each administration leverage to extract some concessions for each generation.
this is very true with the FAA
They’re so concerned with rule making and red tape they forget their actual mission
They’re so concerned with rule making and red tape they forget their actual mission
Isn't the answer lobbyists? A good example is FCC carrying water for them
[deleted]
Who regulates the regulators of regulators?
gitlab won't allow the merge unless it is signed off.
Warren G?
Also, who reviews the peer reviewers?
>What areas of regulation have not fallen into these traps, or at least not as badly? For instance, building codes and restaurant health inspections seem to have helped create safety without killing their respective industries. Driver’s licenses seem to enforce minimal competence without preventing anyone who wants to from driving or imposing undue burden on them. Are there positive lessons we can learn from some of these boring examples of safety regulation that don’t get discussed as much?
I'm pretty sure Louis Rossman has a massive playlist making fun of how hilariously slow NYC's approval process for construction work is. Adjacent to building codes is zoning laws, which exist specifically to make sure American housing is shaped like a speculative investment vehicle[0].
Driver's licenses err the other way: being licensed to drive is hideously easy, suspensions of that license for unsafe driving are far too uncommon, and people regularly flout the rules. Any serious attempt to enforce the law is opposed as draconian, so the law is only enforced on populations that cannot meaningfully fight back[1].
>What other alternative models to review-and-approval exist, and what do we know about them, either empirically or theoretically?
I'm not aware of any. In fact, while the author suggested liability as an alternative; I would argue that liability and review-and-approval are two sides of the same coin. You have some liability, which you don't realize right away because probabilistic outcomes allow lucky individuals and institutions to dodge bullets, and then once you realize your liability is higher than you thought you start engaging in review-and-approval. In the case of the FDA, the liability was the risk of public embarrassment and losing elections for allowing unsafe drugs to hit the market. In the case of factories, the review-and-approval processes are internal and unaccountable. While IRBs can start out well-meaning and degrade into exercises in speculative donkey blanketing[2], the factories will start as a CYA measure.
AI risk is particularly strange, because the biggest risk of AI is just that the technology works as intended. Not just that it works, or doesn't work, but that it works and one company owns it all. A cursory reading of selectorate theory would suggest the ultimate disenfranchisement of everyone but the specific subgroup of capitalists that happen to own parts of OpenAI, Microsoft, or Google. What you need is not risk mitigation, what you need is to force free publication and use of AI software. In other words, Stallman was right[3].
>Why is there so much bloat in the contract research organizations (CROs) that run clinical trials for pharma? Shouldn’t there be competition in that industry too?
Competition is an artifice of the 1970s. When we stopped blocking mergers on antitrust grounds we functionally abandoned the concept of private competition. This is why I don't think liability is a fix. The author thinks that there are still competitive pressures that would disincentivize over-regulation; that is not the case.
[0] Not it's original intent, of course: the original idea was to keep black people out of the suburbs. Like much else in the US, the structure is not perpetuated for the sake of racism, but it is an artifice of vestigial racism.
[1] This is mediated through poverty; rich towns have politically active citizens that will fight back against new ways of enforcing the law. Poor towns can fleece their people at traffic stops, and they don't have to pay their cops as much as long as they can be paid in police brutality. Thanks to vestigial racism induced poverty, this disproportionately affects black people, too.
The dynamics behind this are Cory Doctorow's "shitty technology adoption curve."
[2] Covering your ass.
[3] Also Ned Ludd was right.
I'm pretty sure Louis Rossman has a massive playlist making fun of how hilariously slow NYC's approval process for construction work is. Adjacent to building codes is zoning laws, which exist specifically to make sure American housing is shaped like a speculative investment vehicle[0].
Driver's licenses err the other way: being licensed to drive is hideously easy, suspensions of that license for unsafe driving are far too uncommon, and people regularly flout the rules. Any serious attempt to enforce the law is opposed as draconian, so the law is only enforced on populations that cannot meaningfully fight back[1].
>What other alternative models to review-and-approval exist, and what do we know about them, either empirically or theoretically?
I'm not aware of any. In fact, while the author suggested liability as an alternative; I would argue that liability and review-and-approval are two sides of the same coin. You have some liability, which you don't realize right away because probabilistic outcomes allow lucky individuals and institutions to dodge bullets, and then once you realize your liability is higher than you thought you start engaging in review-and-approval. In the case of the FDA, the liability was the risk of public embarrassment and losing elections for allowing unsafe drugs to hit the market. In the case of factories, the review-and-approval processes are internal and unaccountable. While IRBs can start out well-meaning and degrade into exercises in speculative donkey blanketing[2], the factories will start as a CYA measure.
AI risk is particularly strange, because the biggest risk of AI is just that the technology works as intended. Not just that it works, or doesn't work, but that it works and one company owns it all. A cursory reading of selectorate theory would suggest the ultimate disenfranchisement of everyone but the specific subgroup of capitalists that happen to own parts of OpenAI, Microsoft, or Google. What you need is not risk mitigation, what you need is to force free publication and use of AI software. In other words, Stallman was right[3].
>Why is there so much bloat in the contract research organizations (CROs) that run clinical trials for pharma? Shouldn’t there be competition in that industry too?
Competition is an artifice of the 1970s. When we stopped blocking mergers on antitrust grounds we functionally abandoned the concept of private competition. This is why I don't think liability is a fix. The author thinks that there are still competitive pressures that would disincentivize over-regulation; that is not the case.
[0] Not it's original intent, of course: the original idea was to keep black people out of the suburbs. Like much else in the US, the structure is not perpetuated for the sake of racism, but it is an artifice of vestigial racism.
[1] This is mediated through poverty; rich towns have politically active citizens that will fight back against new ways of enforcing the law. Poor towns can fleece their people at traffic stops, and they don't have to pay their cops as much as long as they can be paid in police brutality. Thanks to vestigial racism induced poverty, this disproportionately affects black people, too.
The dynamics behind this are Cory Doctorow's "shitty technology adoption curve."
[2] Covering your ass.
[3] Also Ned Ludd was right.
> Not it's original intent, of course: the original idea was to keep black people out of the suburbs. Like much else in the US, the structure is not perpetuated for the sake of racism, but it is an artifice of vestigial racism.
Zoning laws limiting new buildings and artificially increasing cost of housing are pretty universal feature in developed world, even in racially homogeneous countries.
Zoning laws limiting new buildings and artificially increasing cost of housing are pretty universal feature in developed world, even in racially homogeneous countries.
Yes, I built a cabin and I can tell you that building codes are pretty dumb. The county wanted me to put an outlet every six feet on a cabin that has no power!
Mount up!
As long as the incentives stay the same, I don't see how a change to, say, liability model, would make any difference. The regulator can still set legal penalties high enough to stop any innovation, if they want to.
Ideally there would be some positive incentive on the regulator as well as negative incentives. Perhaps somehow they could be responsible for the overall success of an industry, rather than just avoiding the negatives.
It's especially hard though when you are regulating foreign businesses. It might be dumb to prevent the Microsoft-Activision merger, but what incentive do UK regulators have to get it right?
If the incentives are all just politics then maybe the only real answer is politics, like the YIMBY movement seems to be somewhat effective at fighting anti-housing regulation. It is not really changing the paradigm per se, it is just changing the rules to be more pro-housing.