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Who regulates the regulators? We need to go beyond review-and-approval

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Re: Who regulates the regulators? We need to go beyond review-and-approval

#21
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.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#22
post #7

Earlier quoted context omitted.

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.

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.

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.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#23
post #3

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…

> 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.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#24
post #4
post #3

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…

> 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 Regul…

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.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#25
>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.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#26

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 re…

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.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#29

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.

Or the insurers are incentivized to lobby for regulation reduction or, worse, cover-ups

Re: Who regulates the regulators? We need to go beyond review-and-approval

#30

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 re…

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...
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