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“What is wrong with physicians?” (from the comments)

My top candidates:

1. Loss of locus of control. People go into medicine to save lives. They believe that they will use their demonstrated intelligence and skills to make a difference. Unfortunately, modern medicine is ever more about turning physicians into box checkers. CPT codes, checklists, facility mandates, perpetual boards … a physician quickly loses control of their working day unless they are weird freaks who do extensively more work to retain control. And beyond that the average physician becomes enculturated to this much earlier. Which medical school you get into is largely a function of where you grew up, went to undergrad, and exactly how well you did on a test that everyone aces with a side of barely legal implicit racial quotas. Your residency is determined by where you went to medical school, where you went to medical school, where/what the top candidates want, and how well you did on a test that everyone aces with a side of barely legal implicit racial quotas. You spend a decade where your locus of control in life is minimal. Then you hit the real world and rather than being set free, you get hit by unending paperwork and yet a thousandth petty demand on your time. If you do research it is not uncommon to spend multiplicatively more time on compliance paperwork. If you head out to make money, you will find that your charge capture is more relevant than the quality of care you provide by an order of magnitude. All of this is a textbook case of loss of locus of control that we know is highly correlated with drug use and depression.

2. There is a wild disconnect between “being a physician” as understood by the public and what you actually live. The public thinks this is still the 1980s when you could pay for medical school working a summer job, residency was three years, and salaries were higher in real terms than they are today. Instead, physicians spend much closer to fifteen years going through training as the needed resume padding has grown at every step along the way. This means that they live longer at resident salaries which are close to US median, but typically are located in high population areas with expensive housing costs. And being a resident physician is not cheap. You have high commuting costs because the regs allow your boss to work you 24 out of 28 days. You can, and will, have weeks with over 100 hours of actual patient care. And again, remember that something like half of residencies are in violation of these rules. And all of this is while nursing a second mortage in undischargable medical school debt. Everyone will think you are rich and that you take fine vacations to Europe and the you will drive a flashy care. And maybe you will, but it will not be until after you are 40 and often 45 that the full physician lifestyle of the movies really comes into play.

3. And then we have the stakes. At every step in a physicians formative adult years you face massive ultra-high stakes events that we know are bad for mental health. College admissions (where you will hit a ceiling for medical schools if you get in too low), MCAT and medical school admissions (which will drastically lower your access to certain specialties if you end up having to go DO), Step and the Match (where you will spend five figures to beg for interviews, the folks on the other side will be unable to differentiate you from the thousands of other applicants, and when you get the interview the only thing of meaning that will come forth is if they like you and if you grew up nearby). Then you have boards and your first job. All of these are massively high stakes and they all require performing quite well relative to your peers. This sort of setup is known in experimental animals and people to lead to depression, anxiety disorders, and drug use.

3. Then we have the punctuated nature of the physician’s life. Going back to medical school, you routinely have long weeks with minimal time to enjoy because studying is rampant. Your entire career can theoretically hang on if you memorized which ultra-rare cancer is caused by which mutation in which gene – even if you want to be a psychiatrist. When you have time “off” this may be the only time you get and there is a very strong tendency toward binges and bacchanals. This will continue to residency where you might have one free weekend in a month (the others being taken up with working and studying), which again lends itself toward binging. And it may continue from there with horrid call schedules and long weeks punctuated by long vacations.

4. The stakes never get lower. You go through with your career riding on high stakes tests and your studying time never being accounted for in your official duties. Boards are now never ending and you face ever more theoretically threatening liability for your decisions.

5. And then there is the obvious stuff. Day in, day out you meet people at their worst. And all your coworkers are doing the same. People cry, threaten, swear, and otherwise abuse you. And nobody wants to get mad at somebody who was just paralyzed from the waist down. Likewise, you can only become so inured to death and dying, we are a social species with extremely large portions of our brains dedicated to feeling empathy for others, physicians see the 5% of humanity who is most obviously suffering as their modal patient.

6. Lastly, whatever you think about physician renumeration, it becomes painfully evident that the golden days were decades ago and there is a small army looking for ways to reduce your renumeration. It will fall disproportionately on you even when the major growth in medical expenses has been nursing, administration, and other warm bodies. Whatever you got paid for a highly taxing job last year, there will be a thousand signs that people think you should do it again for less. People who believe wholeheartedly in the stickiness of wages for reasons of morale and who hold that pay cuts are sufficiently difficult that we need to order international finance around inflation and obviating the need for explicit wage reductions will turn around and concoct wild schemes that explicitly reduce your income in real and nominal terms and question your character should your professional organization (to which you don’t belong) object. All, of course, while the administrators who are generally incompetent at understanding medical practice rake in an ever larger share of the money.

Some of this is US specific, but we have set up medicine to be highly backloaded with its rewards for physicians. We have risen the profession to a vocation and made it a truly arduous task to get through. And at every step along the way physicians have not had access to healthy coping mechanisms and repeated psychic injuries of the sort known to cause or exacerbate these conditions. Major life protective events (e.g. marriage, children, home ownership) are routinely delayed and disrupted by the demands of the training. Why again are we surprised that physicians come out bruised, batter, and willing to take the short term fix for some relief?

That is all from Sure.

The Rise and Decline and Rise Again of Mancur Olson

Mancur Olson’s The Rise and Decline of Nations is one of my favorite books and a classic of public choice. Olson may well have won the Nobel prize had he not died young. He summarized his book in nine implications of which I will present four:

2. Stable societies with unchanged boundaries tend to accumulate more collusions and organizations for collective action over time. The longer the country is stable, the more distributional coalitions they’re going to have.

6. Distributional coalitions make decisions more slowly than the individuals and firms of which they are comprised, tend to have crowded agendas and bargaining tables, and more often fix prices than quantities. Since there is so much bargaining, lobbying, and other interactions that need to occur among groups, the process moves more slowly in reaching a conclusion. In collusive groups, prices are easier to fix than quantities because it is easier to monitor whether other industries are selling at a different price, while it may be difficult to monitor the actual quantities they are producing.

7. Distributional coalitions slow down a society’s capacity to adopt new technologies and to reallocate resources in response to changing conditions, and thereby reduce the rate of economic growth. Since it is difficult to make decisions, and since many groups have an interest in the status quo, it will be more difficult to adopt new technologies, create new industries, and generally adapt to changing environments.

9. The accumulation of distributional coalitions increases the complexity of regulation, the role of government, and the complexity of understandings, and changes the direction of social evolution. As the number of distributional coalitions grows, it will make policy-making increasingly difficult, and social evolution will focus more on distributing wealth among groups than on economic efficiency and growth.

Olson’s book has become less well known over the years but you can gauge it’s continued relevance from this excellent thread by Ezra Klein which gets at some of the consequences of the forces Olson explained:

A key failure of liberalism in this era is the inability to build in a way that inspires confidence in more building. Infrastructure comes in overbudget and late, if it comes in at all. There aren’t enough homes, enough rapid tests, even enough good government web sites. I’ve covered a lot of these processes, and it’s important to say: Most decisions along the way make individual sense, even if they lead to collective failure.

If the problem here was idiots and crooks, it’d be easy to solve. Sadly, it’s (usually) not. Take the parklets. There are fire safety concerns. SFMTA is losing revenue. Some pose disability access issues. It’s not crazy to try and take everyone’s concerns into account. But you end up with an outcome everyone kind of hates.

I’ve seen this happen again and again. Every time I look into it, I talk to well-meaning people able to give rational accounts of their decisions.

It usually comes down to risk. If you do X, Y might happen, and even if Y is unlikely, you really don’t want to be blamed for it. But what you see, eventually, is that our mechanisms of governance have become so risk averse that they are now running *tremendous* risks because of the problems they cannot, or will not, solve. And you can say: Who cares? It’s just parklets/HeathCare.gov/rapid tests/high-speed rail/housing/etc.

But it all adds up.

There’s both a political and a substantive problem here.

The political problem is if people keep watching the government fail to build things well, they won’t believe the government can build things well. So they won’t trust it to build. And they won’t even be wrong. The substantive problem, of course, is that we need government to build things, and solve big problems.

If it’s so hard to build parklets, how do you think think that multi-trillion dollar, breakneck investment in energy infrastructure is going to go?
This isn’t a problem that just afflicts liberal governance, of course.

All these problems were present federally under Trump and Bush. They are present under Republican governors and mayors. But it’s a bigger problem for liberalism because liberalism has bigger public ambitions, and it requires trust in the government to succeed. I’m going to be working a lot over the next year on the idea of supply-side progressivism, and this is an important part.

Why the New Pollution Literature is Credible

My recent post, Air Pollution Reduces Health and Wealth drew some pushback in the comments, some justified, some not, on whether the results of these studies are not subject to p-hacking, forking gardens and the replication crisis. Sure, of course, some of them are. Andrew Gelman, for example, has some justified doubt about the air filters and classroom study. Nevertheless, I don’t think that skepticism about the general thrust of the results is justified. Why not?

First, go back to my post Why Most Published Research Findings are False and note the list of credibility checks. For example, my rule is trust literatures not papers and the new pollution literature is showing consistent and significant negative effects of pollution on health and wealth. Some might respond that the entire literature is biased for reasons of political correctness or some such and sure, maybe. But then what evidence would be convincing? Is skepticism then justified or merely mood affiliation? And when it comes to action should we regard someone’s prior convictions (how were those formed?) as more accurate then a large, well-published scientific literature?

It’s not just that the literature is large, however, it’s that the literature is consistent in a way that many studies in say social psychology were not. In social psychology, for example, there were many tests of entirely different hypotheses–power posing, priming, stereotype threat–and most of these failed to replicate. But in the pollution literature we have many tests of the same hypotheses. We have, for example, studies showing that pollution reduces the quality of chess moves in high-stakes matches, that it reduces worker productivity in Chinese call-centers, and that it reduces test scores in American and in British schools. Note that these studies are from different researchers studying different times and places using different methods but they are all testing the same hypothesis, namely that pollution reduces cognitive ability. Thus, each of these studies is a kind of replication–like showing price controls led to shortages in many different times and places.

Another feature in favor of the air pollution literature is that the hypothesis that pollution can have negative effects on health and cognition wasn’t invented yesterday along with the test (we came up with a new theory and tested it and guess what, it works!). The Romans, for example, noted the negative effect of air pollution on health. There’s a reason why people with lung disease move to the countryside and always have.

I also noted in Why Most Published Research Findings are False that multiple sources and types of evidence are desirable. The pollution literature satisfies this desideratum. Aside from multiple empirical studies, the pollution hypothesis is also consistent with plausible mechanisms and it is consistent with the empirical and experimental literature on pollution and plants and pollution and animals. See also OpenPhilanthropy’s careful summary.

Moreover, there is a clear dose-response effect–so much so that when it comes to “extreme” pollution few people doubt the hypothesis. Does anyone doubt, for example, that an infant born in Delhi, India–one of the most polluted cities in the world–is more likely to die young than if the same infant grew up (all else equal) in Wellington, New Zealand–one of the least polluted cities in the world?  People accept that “extreme” pollution creates debilitating effects but they take extreme to mean ‘more than what I am used to’. That’s not scientific. In the future, people will think that the levels of pollution we experience today are extreme, just as we wonder how people could put up with London Fog.

What is new about the new pollution literature is more credible methods and bigger data and what the literature shows is that the effects of pollution are larger than we thought at lower levels than we thought. But we should expect to find smaller effects with better methods and bigger data.  (Note that this isn’t guaranteed, there could be positive effects of pollution at lower levels, but it isn’t surprising that what we are seeing so far is negative effects at levels previously considered acceptable.)

Thus, while I have no doubt that some of the papers in the new pollution literature are in error, I also think that the large number of high quality papers from different times and places which are broadly consistent with one another and also consistent with what we know about human physiology and particulate matter and also consistent with the literature on the effects of pollution on animals and plants and also consistent with a dose-response relationship suggest that we take this literature and its conclusion that air pollution has significant negative effects on health and wealth very seriously.

Air Pollution Reduces Health and Wealth

Great piece by David Wallace-Wells on air pollution.

Here is just a partial list of the things, short of death rates, we know are affected by air pollution. GDP, with a 10 per cent increase in pollution reducing output by almost a full percentage point, according to an OECD report last year. Cognitive performance, with a study showing that cutting Chinese pollution to the standards required in the US would improve the average student’s ranking in verbal tests by 26 per cent and in maths by 13 per cent. In Los Angeles, after $700 air purifiers were installed in schools, student performance improved almost as much as it would if class sizes were reduced by a third. Heart disease is more common in polluted air, as are many types of cancer, and acute and chronic respiratory diseases like asthma, and strokes. The incidence of Alzheimer’s can triple: in Choked, Beth Gardiner cites a study which found early markers of Alzheimer’s in 40 per cent of autopsies conducted on those in high-pollution areas and in none of those outside them. Rates of other sorts of dementia increase too, as does Parkinson’s. Air pollution has also been linked to mental illness of all kinds – with a recent paper in the British Journal of Psychiatry showing that even small increases in local pollution raise the need for treatment by a third and for hospitalisation by a fifth – and to worse memory, attention and vocabulary, as well as ADHD and autism spectrum disorders. Pollution has been shown to damage the development of neurons in the brain, and proximity to a coal plant can deform a baby’s DNA in the womb. It even accelerates the degeneration of the eyesight.

A high pollution level in the year a baby is born has been shown to result in reduced earnings and labour force participation at the age of thirty. The relationship of pollution to premature births and low birth weight is so strong that the introduction of the automatic toll system E-ZPass in American cities reduced both problems in areas close to toll plazas (by 10.8 per cent and 11.8 per cent respectively), by cutting down on the exhaust expelled when cars have to queue. Extremely premature births, another study found, were 80 per cent more likely when mothers lived in areas of heavy traffic. Women breathing exhaust fumes during pregnancy gave birth to children with higher rates of paediatric leukaemia, kidney cancer, eye tumours and malignancies in the ovaries and testes. Infant death rates increased in line with pollution levels, as did heart malformations. And those breathing dirtier air in childhood exhibited significantly higher rates of self-harm in adulthood, with an increase of just five micrograms of small particulates a day associated, in 1.4 million people in Denmark, with a 42 per cent rise in violence towards oneself. Depression in teenagers quadruples; suicide becomes more common too.

Stock market returns are lower on days with higher air pollution, a study found this year. Surgical outcomes are worse. Crime goes up with increased particulate concentrations, especially violent crime: a 10 per cent reduction in pollution, researchers at Colorado State University found, could reduce the cost of crime in the US by $1.4 billion a year. When there’s more smog in the air, chess players make more mistakes, and bigger ones. Politicians speak more simplistically, and baseball umpires make more bad calls.

As MR readers will know Tyler and I have been saying air pollution is an underrated problem for some time. Here’s my video on the topic:

Nu, a variant of real concern

Here is the Eric Topol thread.  Do read it.  Here is the scary graph, based on preliminary data.  Here is Bloom Lab.  Here is a layperson’s take from the Times of London:

When was the variant first discovered?
South African authorities raised the alarm at 2pm on Tuesday of this week, when they found samples with a significant number of worrying mutations.

The samples dated from tests taken on November 14 and 16. On Wednesday, even as scientists were analysing the genome, other samples were found in Botswana and China, originating from travellers from South Africa.

Why were scientists initially concerned by this variant?
The spike protein is the tool a virus uses to enter cells, and the part of it our vaccines are trained to spot. This variant had 32 mutations in the spike — meaning it would look different to our immune system and behave differently when attacking a body. As a virologist at Imperial College put it, it was a “horrific spike profile”.

Why has worry increased over the course of the week?
When geneticists and virologists looked at the mutations they realised there was a high likelihood they could increase its transmissibility or help it evade immunity. But these concerns were still theoretical. However, today South African scientists spotted a quirk in the testing regimen. PCR tests look for three genes in the coronavirus and amplify them. If, however, the virus was this variant they were only able to amplify two.

In the province of Gauteng, where the proportion of tests coming back positive has rocketed to one in three, they found the proportion in which only two genes were amplified has also rocketed.

What does this mean?
There are three options. It is still possible — though unlikely — this is chance, with the variant’s apparently increased spread relating to an unusual cluster. If it does have a genuine advantage, then it is either better able to spread or better able to infect people who have prior immunity — either from vaccination or infection. Or, it is both.

This might come to nothing, but it is definitely a matter of concern.  One more general point is that even if Nu is a non-event, it seems to show that the space for possible significant mutations is largely than we had thought.

Model this Apple pricing decision

Apple has one new product that’s already so back-ordered it won’t arrive in time for Christmas. It’s a polishing cloth. Priced at $19.

Unveiled in October after Apple showed off its new line of gadgets, the soft, light gray square is made of “nonabrasive material” and embossed with Apple’s logo. During tests, the rag worked like other microfiber cloths that list for less than half that price. So…why $19?

As it happens, Apple’s pricing strategy rarely allows accessories to fall below that threshold. The 6.3-inch swatch of fabric sits beside 17 other Apple-branded items on the company’s website—a mélange of charging cables, dongles and adapters—each priced at $19. Some, such as the wired earbuds and charging adapter, were once included with new iPhones.

Those $19 Apple items—together with the Apple Watch, AirPods and other small gadgets—are part of the company’s growing Wearables, Home and Accessories category, which had more than $8 billion in revenue in the quarter that ended in October.

Almost every Apple price ends in the number “9.”  Would it matter if we all carried around $30 bills?  There is further discussion in this Galvin Brown WSJ piece.

Via the excellent Samir Varma.

Yglesias on CRT

Matt Yglesias has an excellent post on schooling and politics emphasizing three points. First, there is a lot of diversity, equity, inclusion (DEI) nonsense which the schools are using to train teachers and administrators. Second, at the same time the school administrators/teacher’s unions are generally ignoring the very real cost to children and parents of the school closures, including the costs of a widening racial gap. Third, the schools are stigmatizing testing under the guise of promoting equity but in reality because the teacher’s unions know that when you test children you learn that not all teachers are equally capable.

[The DC Public Schools] also recommend that people read a bunch of Robin DiAngelo books and brag that “more than 2,000 DCPS staff have participated in Courageous Conversation training.” But is Courageous Conversation training a good idea? This NYT Magazine profile of the company and its founder made it sound pretty bad:

Singleton, who holds degrees from the University of Pennsylvania and Stanford, and who did stints in advertising and college admissions before founding what’s now known as Courageous Conversation in 1992, talks about white culture in similar ways. There is the myth of meritocracy. And valuing “written communication over other forms,” he told me, is “a hallmark of whiteness,” which leads to the denigration of Black children in school. Another “hallmark” is “scientific, linear thinking. Cause and effect.” He said, “There’s this whole group of people who are named the scientists. That’s where you get into this whole idea that if it’s not codified in scientific thought that it can’t be valid.” He spoke about how the ancient Egyptians had “ideas about how humanity works that never had that scientific-hypothesis construction” and so aren’t recognized. “This is a good way of dismissing people. And this,” he continued, shifting forward thousands of years, “is one of the challenges in the diversity-equity-inclusion space; folks keep asking for data. How do you quantify, in a way that is scientific — numbers and that kind of thing — what people feel when they’re feeling marginalized?” For Singleton, society’s primary intellectual values are bound up with this marginalization.

I don’t think Frankfurt School Marxists are going to take over society by injecting these ideas into K-12 schools or anything like that. What I so think is that time and money is being wasted on initiatives that are run by people who are somewhere between stupid and fraudulent.

And it’s important to take that seriously, not just because someone somewhere may take these goofy ideas seriously (see prior commentary about Tema Okun), but because fiscal tradeoffs are real. Dollars spent on DEI trainings that come with zero proof of efficacy are dollars that can’t be invested in things like D.C.’s successful teacher bonus pay program, updating school air conditioning, improving school lunches, reducing kids’ exposure to air pollution and lead poisoning, or any of the other various interventions that have decent evidence behind them.

Of course when I say that investing in higher quality school lunches is good for kids’ learning, what I mean is that it’s good as measured on standardized tests.

Standardized testing has become a weird discourse flashpoint, but I think everyone agrees that you can, in principle, assess someone’s competence in a given subject area with a test. And if you want to compare different people, you need to give them the same test. It’s only by making comparisons across classrooms and across time that we are able to persuasively demonstrate that particulates are bad for school performance, healthy meals are good for school performance, and air conditioning improves school performance in the summer.

All this would be uncontroversial, I think, except teachers’ unions don’t like the idea of assessing teachers based on their job performance.

Read the whole thing and subscribe to Slow Boring.

The”hot hand” depends on location

Here is new research by Robert M. Lantis and Erik T. Nesson:

Do basketball players exhibit a hot hand? Results from controlled shooting situations suggest the answer is yes, while results from in-game shooting are mixed. Are the differing results because a hot hand is only present in similar shots or because testing for the hot hand in game situations is difficult? Combining repeated shots in a location and shots across locations, the NBA 3-Point Contests mimics game situations without many of the confounding factors. Using data on the 1986-2019 contests, we find a hot hand, but only within shot locations. Shooting streaks increase a hot hand only if a player makes his previous shot and only within locations. Even making three shots in a row has no effect on making the next shot if a player moves locations. Our results suggest that any hot hand in basketball is only present in extremely similar shooting situations and likely not in the run-of-play.

This YouTube video, of Stephen Curry, is one of the greatest videos of all time.

Markets in everything

A Louisiana widow is left horrified at the news that her deceased husband was dissected in front of a live, paying audience after she donated his body to scientific research.

Elsie Saunders had carried out the wishes of her late husband, David Saunders, who wanted his body donated to help advance medical science, according to The Advocate. David Saunders, a World War II and Korean War veteran, died of COVID-19 on August 24 at the age of 98. Donating his body was his last act of patriotism, Elsie Saunders said.

But instead of being delivered to a research facility, David Saunders’ body ended up in a Marriott Hotel ballroom in Portland, Oregon, where DeathScience.org held an “Oddities and Curiosities Expo.” At the October 17 event, members of the public sat ringside from 9 am to 4 pm—with a break for lunch—to watch David Saunders’ body be carefully dissected. Tickets for the dissection sold for up to $500 per person…

Elsie Saunders learned of the dissection from a Seattle-based reporter at KING 5, who was investigating the event and tracked her down. A photojournalist who attended undercover for KING 5 had noted that the body had a bracelet with the typed name “David Saunders.”

“As far as I’m concerned, it’s horrible, unethical, and I just don’t have the words to describe it,” Elsie Saunders told The Advocate. “I have all this paperwork that says his body would be used for science—nothing about this commercialization of his death.”

Are medical students allowed to pay tuition?  Is “science” allowed to balance the books?  Here is the full story, via the excellent Samir Varma.

Addendum: Under other circumstances, it has been common to use donated bodies for crash test dummies.

ProPublica on FDA Delay

If you have been following MR for the last 18 months (or 18 years!) you won’t find much new in this ProPublica piece on FDA delay in approving rapid tests but, other than being late to the game, it’s a good piece. Two points are worth emphasizing. First, some of the problem has been simple bureaucratic delay and inefficiency.

In late May, WHPM head of international sales Chris Patterson said, the company got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies, and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be “deprioritized,” or moved to the back of the line.

“We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,” said Patterson. Meanwhile, the WHPM rapid test has been approved in Mexico and the European Union, where the company has received large orders.

An FDA scientist who vetted COVID-19 test applications told ProPublica he became so frustrated by delays that he quit the agency earlier this year. “They’re neither denying the bad ones or approving the good ones,” he said, asking to remain anonymous because his current work requires dealing with the agency.

Recall my review of Joseph Gulfo’s Innovation Breakdown.

Second, the FDA has engaged in regulatory nationalism–refusing to look at trial data from patients in other countries. This is madness when India does it and madness when the US does it.

For example, the biopharmaceutical giant Roche told ProPublica that it submitted a home test in early 2021, but it was rejected by the FDA because the trials had been done partly in Europe. The test had compared favorably with Abbott’s rapid test, and received European Union approval in June. The company plans to resubmit an application by the end of the year.

A smaller company, which didn’t want to be named because it has other contracts with the U.S. government, withdrew its pre-application for a rapid antigen test with integrated smartphone-based reporting because it heard its trial data from India — collected as the delta variant was surging there — wouldn’t be accepted. Doing the trials in the U.S. would have cost millions.

Photo credit: MaxPixel.

Our regulatory state is failing us, edition #1637

The U.S. Food and Drug Administration (FDA) has authorized the SalivaDirect PCR COVID-19 test created by the Yale School of Public Health for use with pooled saliva samples.

Pooled testing allows labs to combine saliva samples from multiple individuals into a single tube and process the batch as a single test. This approach maintains the clinical sensitivity associated with the real-time reverse transcription polymerase chain reaction tests — the gold standard for detecting SARS-CoV-2, the virus that causes COVID-19 — and gives labs the ability to process the tests far more quickly. The FDA authorizes Yale-designated laboratories to use the SalivaDirect test to pool as many as five samples at a time for SARS-CoV-2 testing.

That is November 2021In July 2020, Alex wrote: “Tyler and I have been pushing pooled testing for months.”

Better to have nothing in the meantime I guess!  In the meantime, only a handful of pooled spit tests have been approved.

Here is the full piece, via DR.

Clement and Tribe Predicted the FDA Catastrophe

Paul Clement and Laurence Tribe

Laboratory developed tests are not FDA regulated–never have been–instead the labs are regulated under the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS. Laboratory developed tests are the kind your doctor orders, they are a service not a product and are not sold directly to patients. Labs develop new tests routinely and they do not apply to the FDA for approval. Despite this long history, the FDA has claimed that it has the right to regulate lab tests and they have merely chosen not to exercise this right for forty years. In 2015, Paul Clement, the former US Solicitor General under George W. Bush, and Laurence Tribe, considered by many to be the leading constitutional lawyer in the United States, wrote an article that rejected the FDA’s claims writing that the “FDA’s assertion of authority over laboratory-developed testing services is clearly foreclosed by the FDA’s own authorizing statute” and “by the broader statutory context.”

Despite lacking statutory authority, the FDA has continued to claim it is authorized to regulate laboratory tests. Indeed, a key failure in the pandemic happened when the FDA issued so-called “guidance documents” saying that any SARS-CoV-II test had to be pre-approved by the FDA. Thus, the FDA reversed the logic of emergency. In ordinary times, pre-approval was not necessary but when speed was of the essence it became necessary to get FDA pre-approval. The FDA’s pre-approval process slowed down testing in the United States and it wasn’t until after the FDA lifted its restrictions in March that tests from the big labs became available.

Clement and Tribe rejected the FDA claims of regulatory authority over laboratory developed tests on historical, statutory, and legal grounds but they also argued that letting the FDA regulate laboratory tests was a dangerous idea. In a remarkably prescient passage, Clement and Tribe (2015, p. 18) warned:

The FDA approval process is protracted and not designed for the rapid clearance of tests. Many clinical laboratories track world trends regarding infectious diseases ranging from SARS to H1N1 and Avian Influenza. In these fast-moving, life-or-death situations, awaiting the development of manufactured test kits and the completion of FDA’s clearance procedures could entail potentially catastrophic delays, with disastrous consequences for patient care.

Clement and Tribe nailed it. Catastrophic delays, with disastrous consequences for patient care is exactly what happened.

Addendum: See also my pre-pandemic piece on this issue, Our DNA, Our Selves.

The Promising Pathway Act

Operation Warp Speed showed that we can move much faster. FDA delay in approving rapid tests shows that we should move much faster. There is a window of opportunity for reform. The excellent Bart Madden and Siri Terjesen argue for the Promising Pathways Act.

One particularly exciting development is the Promising Pathway Act (PPA), recently introduced in Congress. PPA would reduce bureaucracy via legal changes and provide individuals with efficient early access to potential new drugs.

Under PPA, new drugs will receive provisional approval five to seven years earlier than the status quo via a two-year provisional approval. Drugs that demonstrate patient benefits could be renewed for a maximum of six years, and the FDA could grant full approval at any time based on real-world as opposed to clinical trial data documenting favorable treatments results.

The PPA allows patients, advised by their doctors, to choose early access to promising but not-yet-FDA -approved drugs. Patients and doctors would make informed decisions about using either approved or new medicines that demonstrate safety and initial effectiveness compared to approved drugs.

…Patients and doctors can log into an internet registry database for early access drugs that would contain treatment outcomes, side effects, genetic data, and biomarkers. Scientific researchers, as well as patients, will also benefit from the identification of subgroups of patients who do exceptionally well or fail to respond.

Data from the registry will open knowledge pathways to improve the biopharmaceutical industry’s research outlays to benefit future patients.

With radically lower regulatory costs plus heightened competition as more companies participate, expect substantially lower prescription drug prices for provisional approval drugs.

Here is the text of the PPA.

FDA Approves American Rapid Antigen Test

I wrote earlier:

What makes the FDAs failure to approve more rapid antigen tests even more galling is that the test being sold cheaply in the Amsterdam supermarket is the Flowflex, an American test made by Acon Labs in San Diego.

Well the FDA has finally approved the Acon test! Apparently it is good enough for the Germans and for US citizens. Hoorah! USA Today notes:

ACON expects to make 100 million tests per month by the end of this year. Production could double to 200 million monthly tests by February, according to the FDA.

…The United Kingdom and Germany have made significant purchases of home tests and widely distributed them to their residents to slow the spread of coronavirus. Such large government purchases allowed manufacturers to continue making tests even when demand softened as cases dropped.

The Biden administration will spend nearly $1.2 billion to purchase up to 187 million home tests from Abbott Laboratories and Celltrion Inc., company officials confirmed. The Department of Defense announced additional contracts totaling $647 million to buy 60 million kits from Abbott and three other testing vendors: OraSure Technologies, Quidel and Intrivio Holdings.

The FDA has authorized seven antigen-based tests that can be used at home without a prescription. The EU has authorized 21 tests beginning with the letter A (I am not sure all of these are authorized for home use but you get the idea.) Turtle slow. Still this is a big improvement.

Frankly, I think all the pressure from people like Michael Mina amplified by myself and others over 18 months and culminating in David Leonhartd’s NYTimes article Where Are the Tests? finally pushed them over the edge.