Category: Law
Pandemic Preparation Without Romance
My latest paper, Pandemic Preparation Without Romance, has just appeared at Public Choice.
Abstract: The COVID-19 pandemic, despite its unprecedented scale, mirrored previous disasters in its predictable missteps in preparedness and response. Rather than blaming individual actors or assuming better leadership would have prevented disaster, I examine how standard political incentives—myopic voters, bureaucratic gridlock, and fear of blame—predictably produced an inadequate pandemic response. The analysis rejects romantic calls for institutional reform and instead proposes pragmatic solutions that work within existing political constraints: wastewater surveillance, prediction markets, pre-developed vaccine libraries, human challenge trials, a dedicated Pandemic Trust Fund, and temporary public–private partnerships. These mechanisms respect political realities while creating systems that can ameliorate future pandemics, potentially saving millions of lives and trillions in economic damage.
Here’s one bit:
…in the aftermath of an inadequate government response to an emergency, we often hear calls to reorganize and streamline processes and to establish a single authority with clear responsibility and decision-making power to overcome bureaucratic gridlock. By centralizing authority, it is argued that the government can respond more swiftly and effectively, reducing the inefficiencies caused by a fragmented system.
Yet, the tragedy of the anti-commons was also cited to explain the failure of the government after 9/11. Indeed, the Department of Homeland Security was created to centralize a fragmented system and allow it to act with alacrity. Isn’t a pandemic a threat to homeland security? And what about the Swine Flu pandemic of 2009? While not nearly as deadly as the COVID pandemic, 60 million Americans were sickened, some 274 thousand hospitalized with over 12 thousand deaths (Shresha et al. 2011). Wasn’t this enough practice to act swiftly?
Rather than advocating for a reorganization of bureaucracies, I propose accepting the tragedy of the anti-commons as an inevitable reality. The tragedy of the commons is an equilibrium outcome of modern-day bureaucracy. Bureaucracy has its reasons and some of those reasons may even be reasonable (Wittman 1995). It is too much to expect the same institution to respond to the ordinary demands of day-to-day politics and to the very different demands of emergencies. Indeed, when an institution evolves to meet the demands of day-to-day politics it inevitably develops culture, procedures and processes that are not optimized for emergencies.
Instead of rearranging organization charts we should focus on what has proven effective: the creation of ad-hoc, temporary, public–private organizations. Two notable examples are Operation Warp Speed in the United States and the British Vaccine Taskforce. These entities were established quickly and operated outside regular government channels, free from the typical procurement, hiring, or oversight rules that hinder standard bureaucracies.
…Operation Warp Speed exemplified the “American Model” of emergency response. Rather than relying on command-and-control or government production, the American Model leverages the tremendous purchasing power of the US government with the agility and innovation of the private sector.
The only problem with the “American Model” was its inconsistent application.
I am especially fond of this paper because it is the first, to my knowledge, to cite separate papers from Alex, Maxwell and Connor Tabarrok.
Addendum: This paper isn’t about lockdowns. It’s about avoiding lockdowns!
It’s happening, UAE edition
The United Arab Emirates aims to use AI to help write new legislation and review and amend existing laws, in the Gulf state’s most radical attempt to harness a technology into which it has poured billions.
The plan for what state media called “AI-driven regulation” goes further than anything seen elsewhere, AI researchers said, while noting that details were scant. Other governments are trying to use AI to become more efficient, from summarising bills to improving public service delivery, but not to actively suggest changes to current laws by crunching government and legal data.
“This new legislative system, powered by artificial intelligence, will change how we create laws, making the process faster and more precise,” said Sheikh Mohammad bin Rashid Al Maktoum, the Dubai ruler and UAE vice-president, quoted by state media. Ministers last week approved the creation of a new cabinet unit, the Regulatory Intelligence Office, to oversee the legislative AI push.
Here is more from the FT.
Our non-eggcellent regulations
Germany, Italy, Poland and Sweden are among the nations the U.S. Department of Agriculture approached to address the shortage brought on by a bird flu outbreak, according to European industry groups.
But supplying Americans with eggs would be complicated for foreign producers — but not because of political tensions over the myriad import tariffs President Donald Trump has imposed or threatened to impose on his nation’s top trading partners.
Even if they were eager to share, European countries don’t have many surplus eggs because of their own avian flu outbreaks and the growing domestic demand ahead of Easter.
One of the biggest obstacles, however, is the approach the United States takes to preventing salmonella contamination. U.S. food safety regulations require fresh eggs to be sanitized and refrigerated before they reach shoppers; in the European Union, safety standards call for Grade A eggs to be sold unwashed and without extended chilling.
Here is the full story, via Rich Dewey. So no, American scientists will not be moving to Europe — their eggs are too dangerous. And yes it is Germany too:
It is common in parts of Europe, for example, for consumers to buy eggs that still have feathers and chicken poop stuck to them.
Here is Patrick Collison, comparing the virtues of America to the virtues of Europe. I do not mind that he left out the chicken poop, for me it is a sign of authenticity. As for eggs, the best ones I ever had were in Chile.
Bastiat’s revenge
“S.F. auto glass shops suffering as car break-ins drop”
Here is the San Francisco Chronicle link, via Air Genius Gary Leff.
Book ban sentences to ponder
Using a staggered difference-in-differences design, we find that the circulations of banned books increased by 12%, on average, compared with comparable nonbanned titles after the ban. We also find that banning a book in a state leads to increased circulation in states without bans. We show that the increase in consumption is driven by books from lesser-known authors, suggesting that new and unknown authors stand to gain from the increasing consumer support. Additionally, our results demonstrate that books with higher visibility on social media following the ban see an increase in consumption, suggesting a pivotal role played by social media. Using patron-level data from the Seattle Public Library that include the borrower’s age, we provide suggestive evidence that the increase in readership in the aggregate data is driven, in part, by children reading a book more once it is banned. Using data on campaign emails sent to potential donors subscribed to politicians’ mailing lists, we show a significant increase in mentions of book ban-related topics in fundraising emails sent by Republican candidates.
That is from a new paper by Uttara M. Ananthakrishnan, et.al., via Kris Gulati.
The roots of gun violence
An estimated 80 percent [of U.S: gun shootings] seem to instead be crimes of passion — including rage. They’re arguments that could be defused but aren’t, then end in tragedy because someone has a gun. Most violent crimes are the result of human behavior gone temporarily haywire, not premeditated acts for financial benefit.
That is from the new and interesting Unforgiving Places: The Unexpected Origins of American Gun Violence, by Jens Ludwig.
How to do regulatory reform (from my email)
“Philip Howard here. I enjoyed your discussion with Jen Pahlka. Here are a few notes:
1. This current system needs disrupting, but I fear DOGEs indiscriminate cuts are making the status quo look good. Here’s Peter Drucker, criticizing Gore’s reinventing got: “patching. It always fails. The next step is to rush into downsizing. Management picks up a meat-ax and lays about indiscriminately. …amputation before diagnosis.” (from Management, revised ed).
2. Most of the newcomers to the realization that govt is paralyzed (Ezra Klein, Dunkelman etc) think that the red tape jungle can be pruned, or organized with better feedback loops (Pahlka). This is falling into Gore’s pit. There’s a fatal defect: the operating system is designed around legal compliance–instead of human authority to make tradeoff judgments. Law should be a framework setting the boundaries of authority, not a checklist. That’s why some reforms I championed (page limits, time limits) haven’t worked; there’s always another legal tripwire. I describe what a new framework should look like in this recent essay. https://manhattan.institute/article/escape-from-quicksand-a-new-framework-for-modernizing-america
3. Public unions: Democracy loses its link to voters–quite literally–if elected executives lack managerial authority. The main tools of management– accountability, resource allocation, and daily direction–have been either removed by union controls or are subject to union veto. Government is more like a scrum than a purposeful organization. There’s a core constitutional principle –private nondelegation–that prevents elected officials from ceding their governing responsibility to private groups. Stone v Mississippi: “The power of governing is a trust…, no part of which can be granted away.” That’s the basis of the constitutional challenge we’re organizing. The Trump admin could transform state and local govt by invoking this principle.
Fwiw, I see these points– authority to make tradeoff judgments, authority to manage— as microeconomic necessities, not policy positions. Nothing can work sensibly until people are free to make things work. We’re organizing a forum at Columbia Law School, The Day After Doge, on the morning of April 23. Here’s the lineup. https://www.commongood.org/the-day-after-doge. Let me know if you’d like to weigh in.”
My Conversation with the excellent Jennifer Pahlka
Here is the audio, video, and transcript. Here is the episode summary:
Jennifer Pahlka believes America’s bureaucratic dysfunction is deeply rooted in outdated processes and misaligned incentives. As the founder of Code for America and co-founder of the United States Digital Service, she has witnessed firsthand how government struggles to adapt to the digital age, often trapped in rigid procedures and disconnected from the real-world impact of its policies. Disruption is clearly needed, she says—but can it be done in a way that avoids the chaos of DOGE?
Tyler and Jennifer discuss all this and more, including why Congress has become increasingly passive, how she’d go about reforming government programs, whether there should be less accountability in government, how AGI will change things, whether the US should have public-sector unions, what Singapore’s effectiveness reveals about the trade-offs of technocratic governance, how AI might fundamentally transform national sovereignty, what her experience in the gaming industry taught her about reimagining systems, which American states are the best-governed, the best fictional depictions of bureaucracy, how she’d improve New York City’s governance, her current work at the Niskanen Center, and more.
Excerpt:
COWEN: Does that mean we need something like DOGE? I’ve lived near DC for about 40 years of my life. I haven’t seen anyone succeed with regulatory reforms. You can abolish an agency, but to really reform the process hasn’t worked. Maybe the best iteration we can get is to break a bunch of things now. That will be painful, people will hate it, but you have a chance in the next administration to put some of them back together again.
Maybe it’s just in a large country, there’s no other way to do it. We have separation of powers. The first two years of DOGE will seem terrible, but 8, 12, 16 years from now, we’ll be glad we did it. Is that possible?
PAHLKA: I don’t know what’s going to happen. I do think this is the disruption that we’re getting, whether it’s the disruption we wanted. The question of whether it could have been done in a more orderly manner is a tough one. I just feel sad that we didn’t try.
COWEN: Are you sure we didn’t try?
PAHLKA: I don’t think we really tried.
COWEN: The second Bush presidency, people talked about this, what we need to do. Al Gore — some of that was good, in fact, reinventing government. We’ve been trying all along, but this is what trying looks like.
PAHLKA: Yes. I think reinventing government happened at a time when we were just at the beginning of this digital revolution. It was trying with a very 20th-century mindset. Fine, did well within that context, but we don’t need that again.
We need 21st century change. We need true digital transformation. We need something that’s not stuck in the industrial ways of thinking. I don’t think we tried that. I think the efforts have just been too respectful of old ways of working and the institutions. There was really not an appetite, I think, for what I would call responsible disruptive change. Would it have worked?
COWEN: Is there such a thing?
PAHLKA: I don’t know. [laughs]
COWEN: Say you’re approaching USAID, where I think the best programs are great. A lot of it they shouldn’t be doing. On net, it passes a cost-benefit test, but the agency internally never seemed willing to actually get rid of the bad stuff, all the contracting arrangements which made American Congress people happy because it was dollars sent to America, but way inflated overhead and fixed costs. Why isn’t it better just to blow that up — some of it is great — and then rebuild the great parts?
PAHLKA: It’s so hard to say. [laughs] I’ve had the same thought. In fact, before inauguration, I wrote about the Department of Defense. It’s the same thing. There’s a clear recognition by the people in the institution, as you saw with USAID, that this is not okay, that this is not working. It’s just strange to be in an institution that large where so many people agree that it’s not working, from the bottom to the top, and yet nobody can make really substantive change.
Of great interest, obviously.
One economist removed from the Naval library
Deirdre McCloskey, can you guess which book? See #197. I might add the text to that one is remarkably non-salacious, perhaps many readers were somewhat disappointed.
Via the excellent CW.
Federal Judge Rejects FDA Power Grab
In Don’t Let the FDA Regulate Lab Tests! and The New FDA and the Regulation of Laboratory Developed Tests I warned that the FDA’s power grab over laboratory developed tests was both unlawful and likely to result in deadly harm (as it did during COVID). Thus, I am pleased that a Federal judge has vacated the FDA’s rule entirely, writing:
…the text, structure, and history of the FDCA and CLIA make clear that FDA lacks the authority to regulate laboratory-developed test services.
…FDA’s asserted jurisdiction over laboratory-developed test services as “devices” under the FDCA defies bedrock principles of statutory interpretation, common sense, and longstanding industry practice.
The judge also noted some of the costs that I had pointed to:
…the Fifth Circuit has made clear that district courts should generally “nullify and revoke” illegal agency action, Braidwood, 104 F.4th at 951. The Court finds that such relief is appropriate here. The final rule will initially impact nearly 80,000 existing tests offered by almost 1,200 laboratories, and it will also affect about 10,013 new tests offered every year going forward. The estimated compliance costs for laboratories across the country will total well over $1 billion per year, and over the next two decades, FDA projects that total costs associated with the rule will range from $12.57 billion to $78.99 billion. FDA acknowledges that the enormous increased costs to laboratories may cause price increases and reduce the amount of revenue a laboratory can invest in creating and modifying tests.
… For these reasons, it is ORDERED that the Laboratory Plaintiffs’ Motions for Summary Judgment, (Dkt. #20, #27), are GRANTED. The final rule is hereby SET ASIDE and VACATED.
HHS head RFK Jr. should immediately instruct the FDA to halt any further efforts to regulate laboratory developed tests.
AI Discovers New Uses for Old Drugs
The NYTimes has an excellent piece by Kate Morgan on AI discovering new uses for old drugs:
A little over a year ago, Joseph Coates was told there was only one thing left to decide. Did he want to die at home, or in the hospital?
Coates, then 37 and living in Renton, Wash., was barely conscious. For months, he had been battling a rare blood disorder called POEMS syndrome, which had left him with numb hands and feet, an enlarged heart and failing kidneys. Every few days, doctors needed to drain liters of fluid from his abdomen. He became too sick to receive a stem cell transplant — one of the only treatments that could have put him into remission.
“I gave up,” he said. “I just thought the end was inevitable.”
But Coates’s girlfriend, Tara Theobald, wasn’t ready to quit. So she sent an email begging for help to a doctor in Philadelphia named David Fajgenbaum, whom the couple met a year earlier at a rare disease summit.
By the next morning, Dr. Fajgenbaum had replied, suggesting an unconventional combination of chemotherapy, immunotherapy and steroids previously untested as a treatment for Coates’s disorder.
Within a week, Coates was responding to treatment. In four months, he was healthy enough for a stem cell transplant. Today, he’s in remission.
The lifesaving drug regimen wasn’t thought up by the doctor, or any person. It had been spit out by an artificial intelligence model.
AI is excellent at combing through large amounts of data to find surprising connections.
Discovering new uses for old drugs has some big advantages and one disadvantage. A big advantage is that once a drug has been approved for some use it can be prescribed for any use–thus new uses of old drugs do not have to go through the lengthy and arduous FDA approval procedures. In essence, off-label uses have been safety-tested but not FDA efficacy-tested in the new use. I use this fact about off-label prescribing to evaluate the FDA. During COVID, for example, the British Recovery trial, discovered that the common drug, dexamethasone could reduce mortality by up to one-third in hospitalized patients on oxygen support that knowledge was immediately applied, saving millions of lives worldwide:
Within hours, the result was breaking news across the world and hospitals were adopting the drug into the standard care given to all patients with COVID-19. In the nine months following the discovery, dexamethasone saved an estimated one million lives worldwide.
New uses for old drugs are typically unpatentable, which helps keep them cheap—but the disadvantage is that this also weakens private incentives to discover them. While FDA trials for these new uses are often unnecessary, making development costs much lower, the lack of strong market protection can still deter investment. The FDA offers some limited exclusivity through programs like 505(b)(2), which grants temporary protection for new clinical trials or safety and efficacy data. These programs are hard to calibrate—balancing cost and reward is difficult—but likely provide some net benefits.
The NIH should continue prioritizing research into unpatentable treatments, as this is where the market is most challenged. More broadly, research on novel mechanisms to support non-patentable innovations is valuable. That said, I’m not overly concerned about under-investment in repurposing old drugs, especially as AI further reduces the cost of discovery.
Peter Marks Forced Out at FDA
Peter Marks was key to President Trump’s greatest first-term achievement: Operation Warp Speed. In an emergency, he pushed the FDA to move faster—against every cultural and institutional incentive to go slow. He fought the system and won.
I had some hope that FDA commissioner Marty Makary would team with Marks at CBER. Makary understands that the FDA moves too slowly. He wrote in 2021:
COVID has given us a clear-eyed look at a broken Food and Drug Administration that’s mired in politics and red tape.
Americans can now see why medical advances often move at turtle speed. We need fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.
This starts at the top. Our public health leaders have become too be accepting of the bureaucratic processes that would outrage a fresh eye. For example, last week the antiviral pill Molnupiravir was found to cut COVID hospitalizations in half and, remarkably, no one who got the drug died.
The irony is that Molnupiravir was developed a year ago. Do the math on the number of lives that could have been saved if health officials would have moved fast, allowing rolling trials with an evaluation of each infection and adverse event in real-time. Instead, we have a process that resembles a 7-part college application for each of the phase 1, 2, and 3 clinical trials.
A Makary-Marks team could have moved the FDA in a very promising direction. Unfortunately, disputes with RFK Jr proved too much. Marks was especially and deservedly outraged by the measles outbreak and the attempt to promote vitamins over vaccines:
“It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote in a resignation letter referring to HHS Secretary Robert F. Kennedy Jr.
Thus, as of now, the FDA is moving in the wrong direction and Makary has lost an ally against RFK.
In other news, the firing of FDA staff is slowing down approvals, as I predicted it would.
Rethinking regulatory fragmentation
Regulatory fragmentation occurs when multiple federal agencies oversee a single issue. Using the full text of the Federal Register, the government’s official daily publication, we provide the first systematic evidence on the extent and costs of regulatory fragmentation. Fragmentation increases the firm’s costs while lowering its productivity, profitability, and growth. Moreover, it deters entry into an industry and increases the propensity of small firms to exit. These effects arise from redundancy and, more prominently, from inconsistencies between government agencies. Our results uncover a new source of regulatory burden, and we show that agency costs among regulators contribute to this burden.
That is from a new paper by Joseph Kalmenovitz, Michelle Lowry, and Ekaterina Volkova, forthcoming in Journal of Finance. Via the excellent Kevin Lewis.
What Follows from Lab Leak?
Does it matter whether SARS-CoV-2 leaked from a lab in Wuhan or had natural zoonotic origins? I think on the margin it does matter.
First, and most importantly, the higher the probability that SARS-CoV-2 leaked from a lab the higher the probability we should expect another pandemic.* Research at Wuhan was not especially unusual or high-tech. Modifying viruses such as coronaviruses (e.g., inserting spike proteins, adapting receptor-binding domains) is common practice in virology research and gain-of-function experiments with viruses have been widely conducted. Thus, manufacturing a virus capable of killing ~20 million human beings or more is well within the capability of say ~500-1000 labs worldwide. The number of such labs is growing in number and such research is becoming less costly and easier to conduct. Thus, lab-leak means the risks are larger than we thought and increasing.
A higher probability of a pandemic raises the value of many ideas that I and others have discussed such as worldwide wastewater surveillance, developing vaccine libraries and keeping vaccine production lines warm so that we could be ready to go with a new vaccine within 100 days. I want to focus, however, on what new ideas are suggested by lab-leak. Among these are the following.
Given the risks, a “Biological IAEA” with similar authority as the International Atomic Energy Agency to conduct unannounced inspections at high-containment labs does not seem outlandish. (Indeed the Bulletin of Atomic Scientists are about the only people to have begun to study the issue of pandemic lab risk.) Under the Biological Weapons Convention such authority already exists but it has never been used for inspections–mostly because of opposition by the United States–and because the meaning of biological weapon is unclear, as pretty much everything can be considered dual use. Notice, however, that nuclear weapons have killed ~200,000 people while accidental lab leak has probably killed tens of millions of people. (And COVID is not the only example of deadly lab leak.) Thus, we should consider revising the Biological Weapons Convention to something like a Biological Dangers Convention.
BSL3 and especially BSL4 safety procedures are very rigorous, thus the issue is not primarily that we need more regulation of these labs but rather to make sure that high-risk research isn’t conducted under weaker conditions. Gain of function research of viruses with pandemic potential (e.g. those with potential aerosol transmissibility) should be considered high-risk and only conducted when it passes a review and is done under BSL3 or BSL4 conditions. Making this credible may not be that difficult because most scientists want to publish. Thus, journals should require documentation of biosafety practices as part of manuscript submission and no journal should publish research that was done under inappropriate conditions. A coordinated approach among major journals (e.g., Nature, Science, Cell, Lancet) and funders (e.g. NIH, Wellcome Trust) can make this credible.
I’m more regulation-averse than most, and tradeoffs exist, but COVID-19’s global economic cost—estimated in the tens of trillions—so vastly outweighs the comparatively minor cost of upgrading global BSL-2 labs and improving monitoring that there is clear room for making everyone safer without compromising research. Incredibly, five years after the crisis and there has be no change in biosafety regulation, none. That seems crazy.
Many people convinced of lab leak instinctively gravitate toward blame and reparations, which is understandable but not necessarily productive. Blame provokes defensiveness, leading individuals and institutions to obscure evidence and reject accountability. Anesthesiologists and physicians have leaned towards a less-punitive, systems-oriented approach. Instead of assigning blame, they focus in Morbidity and Mortality Conferences on openly analyzing mistakes, sharing knowledge, and redesigning procedures to prevent future harm. This method encourages candid reporting and learning. At its best a systems approach transforms mistakes into opportunities for widespread improvement.
If we can move research up from BSL2 to BSL3 and BSL4 labs we can also do relatively simple things to decrease the risks coming from those labs. For example, let’s not put BSL4 labs in major population centers or in the middle of a hurricane prone regions. We can also, for example, investigate which biosafety procedures are most effective and increase research into safer alternatives—such as surrogate or simulation systems—to reduce reliance on replication-competent pathogens.
The good news is that improving biosafety is highly tractable. The number of labs, researchers, and institutions involved is relatively small, making targeted reforms feasible. Both the United States and China were deeply involved in research at the Wuhan Institute of Virology, suggesting at least the possibility of cooperation—however remote it may seem right now.
Shared risk could be the basis for shared responsibility.
Bayesian addendum *: A higher probability of a lab-leak should also reduce the probability of zoonotic origin but the latter is an already known risk and COVID doesn’t add much to our prior while the former is new and so the net probability is positive. In other words, the discovery of a relatively new source of risk increases our estimate of total risk.
Not the precedent I have been looking for
The Federal Communications Commission is prepared to block mergers and acquisitions involving companies that continue promoting diversity, equity and inclusion policies, FCC Chairman Brendan Carr said Friday.