[HN Gopher] Who regulates the regulators? We need to go beyond r...
___________________________________________________________________
Who regulates the regulators? We need to go beyond review-and-
approval
Author : jasoncrawford
Score : 127 points
Date : 2023-05-05 15:42 UTC (7 hours ago)
(HTM) web link (rootsofprogress.org)
(TXT) w3m dump (rootsofprogress.org)
| [deleted]
| Glyptodon wrote:
| 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.
| paulddraper wrote:
| 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.
| jcq3 wrote:
| Who regulates the regulators of regulators?
| pandemicsyn wrote:
| Warren G?
| m463 wrote:
| gitlab won't allow the merge unless it is signed off.
| anon223345 wrote:
| this is very true with the FAA
|
| They're so concerned with rule making and red tape they forget
| their actual mission
| version_five wrote:
| 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.
|
| This is not limited to drug approvals, and is imo on it's way to
| destroying society. Everything we do it governed by safety
| obsessed technocrats with no understanding of human priorities,
| only of minimizing liability. There needs to be a return to some
| sensible balance.
| derbOac wrote:
| 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.
| PaulKeeble wrote:
| 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.
| rtkwe wrote:
| 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.
| pitaj wrote:
| > 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.
| realjhol wrote:
| 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
| lacker wrote:
| I think the core problem is the incentives of the regulators.
| Groups like the FDA are democratic institutions, but if their
| only goal is to have the approval of national politicians, the
| feedback they get is either negative if there's a bad product
| released, or neutral if there is no terrible product released.
| The FDA must have done something right - what have they done
| right? We don't even know. Their incentives are basically, stop
| as many drugs as possible, but avoid public scandals.
|
| 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.
| marcosdumay wrote:
| > 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.
| pjscott wrote:
| > 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.)
| mcguire wrote:
| 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.
| js8 wrote:
| 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.
| pjscott wrote:
| 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.)
| AnthonyMouse wrote:
| 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.
| BurningFrog wrote:
| Aren't all models vulnerable to "sometimes people in charge
| are idiots"?
| konschubert wrote:
| 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.
| aero142 wrote:
| 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.
| cornholio wrote:
| 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.
| Nifty3929 wrote:
| 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.
| hanniabu wrote:
| > 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.
| jjoonathan wrote:
| 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.
| fallingknife wrote:
| 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.
| Nifty3929 wrote:
| I agree, though I am much less bothered by a proliferation of
| pointless patents than by a dearth of life-saving treatments.
| slavboj wrote:
| 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?
| rt4mn wrote:
| 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)
| firstlink wrote:
| > 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.
| kmeisthax wrote:
| >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.
| zajio1am wrote:
| > 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.
| biomcgary wrote:
| 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.
| majormajor wrote:
| 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.
| fallingknife wrote:
| 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.
| pjscott wrote:
| > 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.
| firstlink wrote:
| All three of these things are orthogonal:
|
| 1) Negligence vs strict liability
|
| 2) Tort model
|
| 3) adversarial truth-seeking
| pbreit wrote:
| Also, who reviews the peer reviewers?
| photochemsyn wrote:
| 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.
| LeifCarrotson wrote:
| 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.
| photochemsyn wrote:
| 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.
| jasoncrawford wrote:
| 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...
| alexfromapex wrote:
| 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.
| sproketboy wrote:
| [dead]
| redandblack wrote:
| Isn't the answer lobbyists? A good example is FCC carrying water
| for them
| konschubert wrote:
| 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.
| ttymck wrote:
| Or the insurers are incentivized to lobby for regulation
| reduction or, worse, cover-ups
| konschubert wrote:
| 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.
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