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

195 pointsby jasoncrawfordabout 2 years ago

23 comments

lackerabout 2 years ago
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&#x27;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&#x27;t even know. Their incentives are basically, stop as many drugs as possible, but avoid public scandals.<p>As long as the incentives stay the same, I don&#x27;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.<p>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.<p>It&#x27;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?<p>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.
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photochemsynabout 2 years ago
This is a curious extract - why didn&#x27;t the author do the obvious research?<p>&gt; &quot;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.&quot;<p>There have been endless scandals since then related to lax oversight and failures of the process, such as Merck&#x27;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.<p>&gt; &quot;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.&quot;<p><a href="https:&#x2F;&#x2F;www.latimes.com&#x2F;archives&#x2F;la-xpm-2000-jul-22-mn-57464-story.html" rel="nofollow">https:&#x2F;&#x2F;www.latimes.com&#x2F;archives&#x2F;la-xpm-2000-jul-22-mn-57464...</a><p>Then there&#x27;s the movement of clinical trials overseas by the likes of Pfizer to avoid FDA scrutiny, and resulting $7B lawsuits by Nigeria etc.<p><a href="https:&#x2F;&#x2F;www.theguardian.com&#x2F;world&#x2F;2007&#x2F;jun&#x2F;05&#x2F;health.healthandwellbeing1" rel="nofollow">https:&#x2F;&#x2F;www.theguardian.com&#x2F;world&#x2F;2007&#x2F;jun&#x2F;05&#x2F;health.healtha...</a><p>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.
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version_fiveabout 2 years ago
<p><pre><code> 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. </code></pre> This is not limited to drug approvals, and is imo on it&#x27;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.
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majormajorabout 2 years ago
So, summarizing the timeline here:<p>Bad things happened.<p>Review-and-approve regulation happened, things improved.<p>Another bad thing happened, at a much lower scale.<p>Regulators cracked down, professional admins replaced experts, things got buried in red tape.<p>The author argues against review-and-approve but they don&#x27;t present a better alternative than that first review-and-approve. They mention, but don&#x27;t really endorse, liability law models. But today&#x27;s adversarial legal model in the US is <i>also</i> slow, expensive, and results in tons of cover-your-ass legalese at large places.<p>The &quot;ratcheting up&quot; of the regulation enforcement seems like the much bigger problem here than an &quot;review and approve&quot; model itself. The need to look like you&#x27;re doing <i>anything</i> to try to prevent bad things from ever happening.<p>We don&#x27;t see that everywhere - we enforce speeding and reckless driving laws, but sometimes people still die from traffic incidents caused by those. The reaction <i>hasn&#x27;t</i> 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.<p>So is the problem just that politicians don&#x27;t relate or understand something like a medical study as well as they do driving, and don&#x27;t understand the tradeoffs and burden required to try to make sure nothing went wrong, ever? If anything, I&#x27;d expect that to result in industry lobbyists pushing deregulation to have a <i>much</i> easier go of it than they have. So I don&#x27;t get it.
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cycomanicabout 2 years ago
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).<p>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&#x27;s the conservative estimate) as on R&amp;D (they even argue that giving away free samples should not count as marketing I kid you not <a href="https:&#x2F;&#x2F;www.raps.org&#x2F;news-and-articles&#x2F;news-articles&#x2F;2019&#x2F;7&#x2F;do-biopharma-companies-really-spend-more-on-market" rel="nofollow">https:&#x2F;&#x2F;www.raps.org&#x2F;news-and-articles&#x2F;news-articles&#x2F;2019&#x2F;7&#x2F;...</a>).<p>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.<p>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&#x27;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.<p>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.<p>Another example of pressure to reduce regulations are financial regulations. Their reduction arguably gave us (or contributed) to the GFC.
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PaulKeebleabout 2 years ago
Another aspect of this is that a lot of regulation doesn&#x27;t really work, it gets corrupted or bloated in numerous ways because it might help but actually doesn&#x27;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.<p>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&#x27;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.
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biomcgaryabout 2 years ago
We don&#x27;t have a succinct term that captures the real risks of over-regulation (see the Sapir-Whorf hypothesis). I recommend the term &quot;metarisk&quot; to describe the risks that come from being too risk averse. As in: you are too focused on the risk and don&#x27;t understand the metarisk you are creating.<p>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).<p>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.<p>Don&#x27;t get hung up on defining optimality, the metaregulators&#x27; real job is just to have the regulators think twice before letting their block-everything reflex kick in.
konschubertabout 2 years ago
I think the idea of MANDARORY liability insurance against regulatory fines is very interesting.<p>The insurer is motivated to incentivise effective risk-reduction behaviour - the government only has to define the penalties.
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paulddraperabout 2 years ago
People are quick to point out the deficiencies of Adam Smith&#x27;s invisible hand.<p>But then turn around and appeal to an equally dubious deity.
avazhiabout 2 years ago
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.
realjholabout 2 years ago
It&#x27;s all just a mirage. You can never avoid the Iron Law of Oligarchy: it doesn&#x27;t matter what system you think you have - monarchy, democracy, anarchy, dictatorship; what you have always amounts to rule by oligarchs
alexfromapexabout 2 years ago
The problem with hierarchies like &quot;regulators&quot; is that there is never a bidirectional feedback loop. The people who are being regulated should also be able to negatively review poor regulators.
Glyptodonabout 2 years ago
FWIW what I&#x27;ve seen from IRBs isn&#x27;t so much risk aversion as institutional protectionism where they seem to do a good job of keeping things quiet when stuff goes wrong.
fuzzfactorabout 2 years ago
It&#x27;s not just regulators.<p>It&#x27;s bureaucrats across a whole range of activities, or lack of activity thereof.<p>There was an article a while back on HN about the &quot;Bureaucratic Failure Mode&quot; that was worthwhile to look at.
Camouflagerabout 2 years ago
Regulations really don&#x27;t work when you&#x27;re dealing with adults. Anti-social behaviors cannot be regulated. That&#x27;s actually the point of being anti-social.<p>Throughout history, every time you start to count on regulations, the whole thing falls apart pretty quickly. LOOK ELSEWHERE. We didn&#x27;t have this much regulations 30 years ago and things were great.
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gershabout 2 years ago
Do we just need better regulators? We could increase pay and hire larger regulatory staffs to move faster. It seems to work for Singapore.
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w10-1about 2 years ago
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.<p>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&#x27;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).<p>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&#x27;s NGS short-read sequencing), it&#x27;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.<p>How can it be changed? It can&#x27;t. Big pharma is a trillion-dollar golden egg is a nest of the FDA&#x27;s making, and no rational humanistic discourse or broad-based health-care financing issues are going to dislodge those investments.<p>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.
anon223345about 2 years ago
this is very true with the FAA<p>They’re so concerned with rule making and red tape they forget their actual mission
redandblackabout 2 years ago
Isn&#x27;t the answer lobbyists? A good example is FCC carrying water for them
jcq3about 2 years ago
Who regulates the regulators of regulators?
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pbreitabout 2 years ago
Also, who reviews the peer reviewers?
kmeisthaxabout 2 years ago
&gt;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?<p>I&#x27;m pretty sure Louis Rossman has a massive playlist making fun of how hilariously slow NYC&#x27;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].<p>Driver&#x27;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].<p>&gt;What other alternative models to review-and-approval exist, and what do we know about them, either empirically or theoretically?<p>I&#x27;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&#x27;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 <i>start</i> as a CYA measure.<p>AI risk is particularly strange, because the biggest risk of AI is just that the technology works <i>as intended</i>. Not just that it works, or doesn&#x27;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].<p>&gt;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?<p>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&#x27;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.<p>[0] Not it&#x27;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.<p>[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&#x27;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.<p>The dynamics behind this are Cory Doctorow&#x27;s &quot;shitty technology adoption curve.&quot;<p>[2] Covering your ass.<p>[3] Also Ned Ludd was right.
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hk1337about 2 years ago
Mount up!