Category: Law
U.S.A. fact of the day
Hispanics are slightly less likely to be jailed than whites…
A Council on Criminal Justice analysis found that in 2000, the rate of being on probation was 1.6 times higher and the rate of being parole was 3.6 times higher for Hispanics than non-Hispanic whites. But by 2016, the probation disparity had disappeared and the parole disparity had shrunk by 85%. Hispanics still faced a 60% higher risk of being incarcerated in a state prison. This is an enormous and worrying disparity, but the Council noted that it decreased by 60% since 2000…
The dwindling of Hispanic-white disparities is even more remarkable in light of criminal behavior being so heavily concentrated in adolescence and young adulthood,. The median age for Hispanics is 29.8 years versus 43.7 for whites, meaning even in a system free of prejudice that punished solely on the basis of crimes committed, we would expect criminal justice disparities between the populations to be growing, not shrinking.
That is from the Matt Yglesias Substack, but the actual writer is Keith N. Humphreys.
My Conversation with Zeynep Tufekci
Here is the audio and transcript. Here is part of the summary:
Zeynep joined Tyler to discuss problems with the media and the scientific establishment, what made the lab-leak hypothesis unacceptable to talk about, how her background in sociology was key to getting so many things right about the pandemic, the pitfalls of academic contrarianism, what Max Weber understood about public health crises, the underrated aspects of Kemel Mustapha’s regime, how Game of Thrones interested her as a sociologist (until the final season), what Americans get wrong about Turkey, why internet-fueled movements like the Gezi protests fizzle out, whether Islamic fundamentalism is on the rise in Turkey, how she’d try to persuade a COVID-19 vaccine skeptic, whether public health authorities should ever lie for the greater good, why she thinks America is actually less racist than Europe, how her background as a programmer affects her work as a sociologist, the subject of her next book, and more.
Here is one excerpt:
COWEN: Max Weber — overrated or underrated as a sociologist?
TUFEKCI: Underrated.
COWEN: Why?
TUFEKCI: Part of the reason he’s underrated is because he writes in that very hard-to-read early 19th-century writing, but if you read Max Weber, 90 percent of what you want to understand about the current public health crisis is there in his sociology. Not just him, but sociology organizations and how that works. He’s good at that. I would say underrated, partly because it’s very hard to read. It’s like Shakespeare. You need the modern English version, conceptually, for more people to read it.
I would say almost all of sociology is underrated in how dramatically useful it is. Just ask me any time. Early on, I knew we were going to have a pandemic, completely based on sociology of the moment in early January, before I knew anything about the virus because they weren’t telling us, but you could just use sociological concepts to put things together. Max Weber is great at most of them and underrated.
COWEN: Kemal Mustafa — overrated or underrated?
TUFEKCI: Underrated.
COWEN: Why?
TUFEKCI: Why? My grandmother — she was 12 or 13 when she was in the Mediterranean region — Central Asia, but Mediterranean region, very close to the Mediterranean. She was born the year the Turkish Republic had been founded, 1923, and she was 13 or so. She was just about to be married off, but the republic was a little over a decade — same age as her. They created a national exam to pick talented girls like her. The ones that won the exam got taken to Istanbul to this elite, one of the very few boarding high schools for girls.
The underrated part isn’t just that such a mechanism existed. The underrated part is that the country changed so much in 13 years that her teacher was able to prevail upon the family to let her go. To have a 13-year-old be sent off to Istanbul, completely opposite side of the country, to a boarding school for education — that kind of flourishing of liberation.
I’m not going to deny it was an authoritarian period, and minorities, like Kurds, during that period were brutally suppressed. I can’t make it sound like there was nothing else going on, but in terms of creating a republic out of the ashes of a crumbling empire — I think it’s one of the very striking stories of national transformation, globally, within one generation, so underrated.
There are numerous interesting segments, on varied topics, to be found throughout the dialog.
Why Doesn’t the United States Have Test Abundance?!
We have vaccine abundance in the United States but not test abundance. Germany has test abundance. Tests are easily available at the supermarket or the corner store and they are cheap, five tests for 3.75 euro or less than a dollar each. Billiger! In Great Britain you can get a 14 pack for free. The Canadians are also distributing packs of tests to small businesses for free to test their employees.
In the United States, the FDA has approved less than a handful of true at-home tests and, partially as a result, they are expensive at $10 to $20 per test, i.e. more than ten times as expensive as in Germany. Germany has approved over 50 of these tests including tests from American firms not approved in the United States. The rapid tests are excellent for identifying infectiousness and they are an important weapon, alongside vaccines, for controlling viral spread and making gatherings safe but you can’t expect people to use them more than a handful of times at $10 per use.
We ought to have testing abundance in the US and not lag behind Germany, the UK and Canada. As usual, I say if it’s good enough for the Germans it’s good enough for me.
Addendum: The excellent Michael Mina continues to bang the drum.
Thailand and The WHO on Fractional Dosing
Thailand will study fractional dosing:
Thailand is studying the possibility of injecting coronavirus vaccines under the skin to try to stretch its limited supply, a health official said on Thursday, as the country races to inoculate the public faster amid a worsening epidemic.
“Our previous experience shows that intradermal injections uses 25% of a muscular injection, but triggers the same level of immunity,” head of the medical science department, Supakit Sirilak told reporters.
I am also pleased that the WHO’s SAGE has issued an interim statement on fractional doses:
WHO, with support of the Strategic Advisory Group of Experts (SAGE) on Immunization and its COVID-19 Vaccines Working Group, is reviewing the role of fractionating doses as a dose-sparing strategy in light of global vaccine supply constraints. SAGE is continuously reviewing the literature and has reached out to vaccine manufacturers and the research community for available information.
….While SAGE acknowledges the potential public health benefits of dose-sparing strategies to increase vaccine supply and accelerate population-level vaccination coverage, and possibly also a reduction in reactogenicity, SAGE considers there is currently insufficient evidence to recommend the use of fractional doses. Any use of a fractional dose at this point in time constitutes an off-label use of the vaccine. SAGE encourages research in the area, with a particular emphasis on research into using fractionated doses as potential boosters and fractional doses in children and adolescents. Programmatic and operational considerations should be considered from the start.
The statement is reasonable but could have used some cost-benefit analysis. Given shortages, I’d push for a challenge trial or some field trials. I agree that if we are to have boosters and to vaccinate young children we should be looking very hard at fractional doses as they are likely to be sufficient for purpose and to preserve as much supply as possible for the rest of the world.
By the way, I think you can also see some status quo bias in the WHOs position on boosters: they are not (yet) enthusiastic about increasing supply with fractional doses but they are very negative about reducing supply with boosters. What a miracle that the status quo is just right!
In the context of ongoing global vaccine supply constraints, administration of booster doses will exacerbate inequities by driving up demand and consuming scarce supply while priority populations in some countries, or subnational settings, have not yet received a primary vaccination series.
The WHO also doesn’t note that if developed countries go for boosters then the case for fractional doses elsewhere to make use of the even more limited supply is likely even stronger.
Here’s my paper with co-authors on fractional doses.
Hat tip: Witold.
The problem with fitting third doses into a regulatory structure
That is a key theme of my latest Bloomberg column, here is one excerpt:
In the U.S., President Joe Biden’s administration is now pushing third booster shots for people who already have been vaccinated. That might be a good idea, but it too creates additional uncertainty for travel and migration — and for social interaction more broadly. If three doses are so important, should people be allowed to travel (or for that matter interact indoors) with only two doses? The bar is raised yet again.
Of course the issues do not end with the third dose. If the efficacy of the second dose declines significantly in less than a year, might the same happen with the third dose? How long before four doses are necessary, or maybe five? Or what if yet another significant Covid variant comes along, and only some people have a booster dose against that strain? What then counts as being “sufficiently vaccinated”?
Many Americans seem to be keen to get their third dose, but by the nature of counting that number is fewer than the number willing to get two doses. Furthermore, many people might just tire of the stress of dealing with an ongoing stream of obligatory booster shots and stop at one or two.
The sad reality is that the “two-dose standard” may not last very long, whether abroad or domestically (the same is true of the even weaker one-dose standard with Johnson & Johnson and AstraZeneca). Vaccine mandates will become harder to define and enforce, will be less transparent, and will probably be less popular.
If you tell people that three doses are needed for safety, but two doses are enough to get you into a concert or government building, how are they supposed to sort out the mixed messages? It is not obvious that enough people will get the third dose in a timely manner to make that a workable standard for vaccine passports.
Add to that the problems with the Johnson & Johnson vaccine, which originally the government urged people to get. Now those people are not being given comparable chances to obtain boosters — in fact, they are not yet being given specific guidance at all. Are they orphaned out of any new vaccine passport system, or will (supposedly dangerous?) exceptions be made for them? Or do they just have to start all over?
The big international winner from all this is likely to be Mexico, which has remained an open country and is not relying on vaccine passports. In general I do not admire Mexico’s lackadaisical Covid response, but the country may end up in a relatively favorable position, most of all when it comes to tourism and international business meetings.
As for the U.S. and Europe, the temptation to escalate required safety measures is understandable. But the previous vaccine standards were largely workable ones. If they are made tougher, they might break down altogether.
Recommended.
They had better hurry up and distribute those AstraZeneca doses
Movement data from last weekend show Melburnians engaging in what experts have called thousands of small transgressions with the potential to drive COVID-19 infections higher, as the effect of 200 days of lockdown takes an emotional toll.
Google mobility data compiled by The Age reveals that across the state last Friday and Saturday, people were moving more than at any time since mid-July last year when complacency prompted Premier Daniel Andrews to plunge the state into stage-four lockdown and mandatory mask-wearing.
Last weekend saw a spate of breaches including an organised takeaway pub crawl in Richmond and an engagement party in Caulfield North attended by 69 guests. The couple involved in the illegal party have received $5400 fines. Two of their parents were also fined and other guests are being interviewed.
Some metropolitan municipalities including Glen Eira and Bayside recorded their highest lockdown movement levels last week, ahead of a number of mystery cases appearing in St Kilda.
Professor Mike Toole from Melbourne’s Burnet Institute, who lives in a mobility hotspot in the inner south, said he was shocked to witness large groups of people gathering in parks at the weekend.
Here is the full article, via Rich Dewey. And the Sydney lockdown is now extended until the end of September, with masks mandated for outside as well. Elsewhere:
Walmart, Target and Lowe’s, by contrast, all lifted sales forecasts this week after beating expectations for the three months to the end of July. While demand for toilet paper and cleaning supplies has cooled after 2020s pantry hoarding, the appetite for other products was broad-based. Party supplies, apparel and travel gear flew off Walmart’s shelves. At Home Depot, an early cache of Halloween decorations sold out almost immediately. Swimsuits and children’s clothing were similarly popular at Target and, in another sign of confidence, more customers returned to Walmart and Target store aisles after a year of browsing online.
Here is the associated FT article. Which set of values do you prefer? Which do most people prefer?
The FDA and CDC Standards on the J&J Vaccine and the Immunocompromised are Unintelligible
Last week the FDA authorized and the CDC now recommends a third mRNA booster for the immunocomprimised. The CDC says:
Who Needs an Additional COVID-19 Vaccine?
Currently, CDC is recommending that moderately to severely immunocompromised people receive an additional dose. This includes people who have:
- Been receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking medicine to suppress the immune system
- Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response
That’s very reasonable but the headline is inaccurate because the CDC then goes on to say:
The FDA’s recent EUA amendment only applies to mRNA COVID-19 vaccines, as does CDC’s recommendation.
Emerging data have demonstrated that immunocompromised people who have low or no protection following two doses of mRNA COVID-19 vaccines may have an improved response after an additional dose of the same vaccine. There is not enough data at this time to determine whether immunocompromised people who received the Johnson & Johnson’s Janssen COVID-19 vaccine also have an improved antibody response following an additional dose of the same vaccine.
So if you got one dose of J&J and are immunocompromised then you can’t get a second dose. But if you got two doses of an mRNA (which is already more effective than one dose of J&J) and are immunocompromised then the CDC recommends a third dose. None of this makes any sense. The weasel words there ‘isn’t enough data to determine’ indicate a typical failure to think in Bayesian terms and use all the information available and a typical failure to think in terms of patient welfare and expected cost and benefits.
Notice also the illiberal default. Instead of saying ‘we don’t have data on the J&J vaccine and the immunocompromised so we are not at this time recommending or not recommending boosters but leaving this decision in the hands of patients and their physicians’ they say ‘we don’t have data and so we are forbidding patients and their physicians from making a decision using their own judgment.’
Hat tip: Pharmacist CB.
Shame. Shame. Shame.
The Afghanistan war was an epic disaster. Nothing good came of it. The least we can do as we evacuate, however, is to help all the Afghanis who helped us and who are now under death threat from the Taliban. But our record on Afghan refugees is shameful. At right from Daniel Bier is a chart of Afghan refugees resettled in the United States–604 last year 494 this year (data here). There are more Afghan immigrants accepted under other programs (not just the refugee program) and we have made motions to accept more but it may now be too late.
Canada in contrast is accepting 20,000 refugees.
Canada plans to resettle more than 20,000 vulnerable Afghans including women leaders, human rights workers and reporters to protect them from Taliban reprisals, Immigration Minister Marco Mendicino said on Friday.
The effort is in addition to an earlier initiative to welcome thousands of Afghans who worked for the Canadian government, such as interpreters, embassy workers and their families, he told a news conference.
“As the Taliban continues to take over more of Afghanistan, many more Afghans’ lives are under increasing threat,” he said. He did not provide a timetable.
Defense Minister Harjit Sajjan said some Canadian special forces were in Afghanistan taking part in the relocation effort but gave no details.
“The challenges on the ground are quite immense,” he said.
Build
The excellent Eli Dourado in the NYTimes:
Many of our country’s problems are reducible, in one way or another, to the fact that we have lost the imperative to transform the physical world. While the soft technology of the internet has marched forward, development of real stuff — of steel and concrete — has slowed, hampered by laws that privilege the status quo.
…Under the National Environmental Policy Act, passed in 1969, federal agencies must produce a detailed statement of environmental impacts for any action — including granting a permit — that significantly affects the human environment. In contrast with the ugly motivations driving zoning, NEPA came into existence riding a wave of environmental consciousness. It was motivated by two well-meaning but mistaken beliefs: that material progress was of environmental quality and that environmental justice could be served through more citizen voice.
…If we want to build infrastructure as well as housing, we need to address environmental review as well as zoning. We must protect the environment, but we need not do it indirectly with laws that operate only through paperwork and court cases. We should do it directly — with stricter air and water standards, smarter conservation policies and a carbon tax. A direct approach would enable speedy government decisions and get shovels in the ground. A pro-building, pro-environment deal, eliminating environmental review in favor of these direct protections, could improve the environment through stricter substantive standards and through a stimulative effect on new, clean infrastructure.
How did the most dynamic country on the planet become so sclerotic? We did it to ourselves. We enacted laws that privilege the status quo at the expense of change and progress. We liberally passed out veto rights to anyone with the money and wherewithal to hire a lawyer. If we want to reverse the damage and create a more prosperous future, we must make it easy to build.
This is also a good opportunity to plug Ezra Klein’s excellent interview with Jerusalem Demsas, How Blue Cities Became So Outrageously Unaffordable. Notably, neither Erza nor Jerusalem let the left off the hook. The subtitle of the episode is How did the party of big government become the party of paralysis? Ezra also pushes back appropriately on some of the nuttier ideas like expanding the welfare state would make homeowners less likely to push for zoning restrictions.
In many ways, we are rediscovering Mancur Olson’s The Rise and Decline of Nations.
Our Regulatory State Isn’t Learning
Delta is the fourth wave of covid, and amazingly the US policy response is even more irresolute than the first time around. Our government is like a child, sent next door to get a cup of sugar, who gets as far as the front stoop and then wanders off following a puppy.
The policy response is now focused on the most medically ineffective but most politically symbolic step, mask mandates. An all-night disco in Provincetown turns in to a superspreader event so… we make school kids wear masks in outdoor summer camps? Masks are several decimal places less effective than vaccines, and less effective than “social distance” in the first place.* Go to that all night disco, unvaccinated, but wear a mask? Please.
If we’re going to do NPI (non pharmaceutical interventions), policy other than vaccines, the level of policy and public discussion has tragically regressed since last summer. Last summer, remember, we were all talking about testing. Alex Tabarrok and Paul Romer were superb on how fast tests can reduce the reproduction rate, even with just voluntary isolation following tests. Other countries had competent test and tracing regimes. Have we built that in a year? No. (Are we ready to test and trace the next bug? Double no.)
What happened to the paper-strip tests you could buy for $2.00 at Walgreen’s, get instant results, and maybe decide it’s a bad idea to go to the all night dance party? Interest faded in November. (Last I looked, the sellers and FDA were still insisting on prescriptions and an app sign up, so it cost $50 and insurance “paid for” it.) What happened to detailed local data? Did anyone ever get it through the FDA’s and CDCs thick skulls that even imperfect but cheap and fast tests can be used to slow spread of disease?
…And then we indulge another round of America’s favorite pastime, answers in search of a question. Delta is spreading, so… extend the renter eviction moratorium. People who haven’t paid rent in a year can stay, landlords be damned.
All true. I got dispirited on testing. It’s insane that we don’t have cheap, rapid testing and good ventilation ready for a new school year. As I wrote about earlier, even the American Academy of Pediatrics is shouting from the rooftops that the FDA is deadly slow. The eviction moratorium is a sick joke. Just a backhanded way to redistribute wealth without a shred of justice or reason. Disgusting.
Here’s one more bit (but read the whole thing there is more.)
To learn from the mistakes, and institutionalize better responses would mean to admit there were mistakes. One would think the grand blame-Trump-for-everything narrative would allow us to do that, but the mistakes are deeply embedded in the bureacracies of the administrative state. Unlike bad admirals in WWII, nobody less than Trump himself has lost their job over incompetent covid response. The institutions have an enormous investment in ratifying that they did the best possible job last time. So, as in so many things (financial bailouts!) we institutionalize last time’s mistakes to keep those who made them in power in power — which means we do not learn from mistakes.
Solve All Murders
Defund the police is a bad idea and a terrible slogan. Conor Friedersdorf argues for a better policy and a better slogan, Solve All Murders. He quotes, Jill Leovy, author of Ghettoside:
Forty years after the civil rights movement, impunity for the murder of black men remained America’s great, though mostly invisible, race problem. The institutions of criminal justice, so remorseless in other ways in an era of get-tough sentencing and “preventive” policing, remained feeble when it came to answering for the lives of black murder victims.’
Few experts examined what was evident every day of John Skaggs’s working life: that the state’s inability to catch and punish even a bare majority of murderers in black enclaves such as Watts was itself a root cause of the violence, and that this was a terrible problem—perhaps the most terrible thing in contemporary American life. The system’s failure to catch killers effectively made black lives cheap.
Homicide is the leading cause of death for black males under the age of 44. As Friedersdorf continues:
The absence of policing yields not a safe space where marginalized people thrive, but a nasty, brutish place where violent actors either push people around with impunity or are met with violence by someone who forces them to stop. “When people are stripped of legal protection and placed in desperate straits, they are more, not less, likely to turn on each other,” Leovy wrote. “Lawless settings are terrifying; if people can do whatever they want to each other, there are always enough bullies to make it ugly.”
Moreover, although crime has declined until recently, that beneficial trend may have masked that police may be becoming less productive over time. Nationally a majority of homicides are cleared but the long term tend is down. Moreover, an increasing number of police agencies fail to clear a majority of homicides. In Chicago, for example, less than half of homicides are cleared–that screams too few police not too many. Solve all murders!
We are underpoliced in the United States especially in high-crime areas. We need better policing so that we can all be comfortable with more policing.
The American Academy of Pediatrics Tells the FDA to Speed Up and Stop Endangering Patients
The American Academy of Pediatrics has written a stunning letter to the FDA:
We understand that the FDA has recently worked with Pfizer and Moderna to double the number of children ages 5-11 years included in clinical trials of their COVID-19 vaccines. While we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group. In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children. The FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on data from the initial enrolled cohort, which are already available, while continuing to follow safety data from the expanded cohort in the post-market setting. This approach would not slow down the time to authorization of these critically needed vaccines in the 5–11-year age group.
In addition, as FDA continues to evaluate clinical trial requirements for children under 5 years, we similarly urge FDA to carefully consider the impact of its regulatory decisions on further delays in the availability of vaccines for this age group. Based on scientific data currently available on COVID-19 vaccines, as well as on 70 years of vaccinology knowledge in the pediatric population, the Academy believes that clinical trials in these children can be safely conducted with a 2-month safety follow-up for participants. Assuming that the 2-month safety data does not raise any new safety concerns and that immunogenicity data are supportive of use, we believe that this is sufficient for authorization in this and any other age group. Waiting on a 6-month follow-up will significantly hinder the ability to reduce the spread of the hyper infectious COVID-19 Delta variant among this age group, since it would add 4 additional months before an authorization decision can be considered. Based on the evidence from the over 340 million doses of COVID-19 doses administered to adults and adolescents aged 12-17,as well as among adults 18 and older, there is no biological plausibility for serious adverse immunological or inflammatory events to occur more than two months after COVID-19 vaccine administration.
In my many years of writing about the FDA, I can’t recall a single instance in which a major medical organization told the FDA to use a smaller trial and speed up the process because FDA delay was endangering the safety of their patients. Wow.
The invisible graveyard is invisible no more.
Immigration encouragement as the new form of hybrid warfare?
Baltic officials say his [Lukashenko’s] latest tactic is to offer migrants from Iraq, Syria or several African countries a package that includes passage to the Lithuanian border. More than 4,000 migrants have crossed into Lithuania this year alone, more than 50 times the number that entered last year.
Rinkevics said this was “a very clear case of hybrid warfare” by deliberately using migration to target the EU and Lithuania. “The migrants are actually being used as the weapon. The longer we live in this 21st century, the scarier it becomes. Things that we couldn’t imagine that could be used, they are being used,” he said.
Here is the full FT piece, unsettling throughout.
Is this the correct market price?
This is totally immoral of course, but I am wondering about the elasticity of demand here:
One math lesson Prof. Edward C. Ennels taught at Baltimore City Community College was, according to prosecutors, pretty simple: $150 for a C; $250 for a B; and $500 for an A.
And in some courses, an A could go for as little as $300.
Over the course of seven months last year, Mr. Ennels, 45, solicited bribes from 112 students, and received 10 payments from nine students, totaling $2,815, the Maryland attorney general, Brian E. Frosh, said in a statement on Thursday.
In another scheme, Mr. Ennels sold online access codes that enabled students to view instructional material and complete assignments, prosecutors said. From 2013 to 2020, he sold 694 access codes for about $90 each.
Mr. Ennels, a professor at the college for 15 years who served on the faculty senate’s Ethics and Institutional Integrity Committee, pleaded guilty on Thursday in Baltimore County Circuit Court to 11 misdemeanor charges, including bribery and misconduct in office, according to prosecutors and online court records.
He was sentenced to 10 years in prison with all but one year of the term suspended and to be served in a local jail. He was also ordered to pay $60,000 in restitution and will be on probation for five years upon his release.
Mr. Frosh said in his statement that Mr. Ennels employed “an elaborate criminal scheme to take advantage of his students,” including using multiple aliases to hide his identity.
In March 2020, Mr. Ennels sent an email using one of his aliases, “Bertie Benson,” to another of his aliases, “Amanda Wilbert,” prosecutors said in a statement. In the email, “Benson” offered to complete “Wilbert’s” math assignments, guaranteeing her an A for $300, prosecutors said.
Then, as “Wilbert,” Mr. Ennels forwarded that email to 112 students enrolled in a class that he was teaching, prosecutors said. “Ennels often haggled with students regarding the amount of the bribe, and set different prices based on the course and grade desired,” according to the statement.
Most students declined to pay the bribes and Mr. Ennels “often persisted, offering to lower the amount of the bribe or offering payment plans,” according to the statement.
According to the statement, one student rebuffed the $500 solicitation for an A by saying: “Oh I don’t have that sorry. I will be sure to keep studying and pass my exam.” Mr. Ennels’s response, according to prosecutors: “How much can you afford?”
That student ultimately paid a bribe, according to prosecutors, who did not say how much that particular student paid.
I guess he was wondering about the elasticity of demand too. Here is the full NYT story.
The FDA Is Still Much Too Strict
Here is just one bit from a superb post on the FDA by psychiatrist Scott Alexander at Astral Codex Ten.
I worry that people are going to come away from this with some conclusion like “wow, the FDA seemed really unprepared to handle COVID.” No. It’s not that specific. Every single thing the FDA does is like this. Every single hour of every single day the FDA does things exactly this stupid and destructive, and the only reason you never hear about the others is because they’re about some disease with a name like Schmoe’s Syndrome and a few hundred cases nationwide instead of something big and media-worthy like coronavirus. I am a doctor and sometimes I have to deal with the Schmoe’s Syndromes of the world and every [email protected]$king time there is some story about the FDA doing something exactly this awful and counterproductive.
A while back I learned about Infant Short Bowel Syndrome, a rare condition with only a few hundred cases nationwide. Babies cannot digest food effectively, but you can save their lives by using an IV line to direct nutrients directly into their veins. But you need to use the right nutrient fluid. The FDA approved an early draft of the nutrient fluid, but it didn’t have enough fish oil, which is necessary for development, so a lot of the babies still died or ended up with permanent neurological damage. Around the late 90s/early 00s, researchers figured out what was going on and recommended adding fish oil to the IV fluid. The FDA responded that they had only approved the non-fish-oil version, it would take them a while to approve the new version, and until they did that adding fish oil was illegal. A bunch of babies kept dying and getting permanent neurological damage, and everyone knew exactly how to stop it, but if anyone did the FDA would take away their licenses and shut them down. Around 2010, Boston Children’s Hospital found some loophole that let them add fish oil to their nutrient fluid on site, and infants with short bowel syndrome at that one hospital stopped dying or ending up permanently disabled, and the FDA grudgingly agreed to permit it but banned them from distributing their formulation or letting it cross state lines – so for a while if you wanted your baby not to die you had to have them spend their infancy in one specific hospital in Massachusetts. Around 2015 the FDA said that if your doctor applied for a special exemption, they would let you import the correct nutritional fluid from Europe (where, lacking the FDA, they had just added fish oil to the fluid as soon as researchers discovered it was necessary), but you were only able to apply after your baby had already sustained serious damage, and the FDA might just say no. Finally in 2018 the FDA got around to approving the corrected nutritional fluid and now babies with short bowel syndrome do fine, after twenty years of easily preventable state-mandated deaths. And it’s not just this and coronavirus, I CANNOT STRESS ENOUGH HOW TYPICAL THIS IS OF EVERYTHING THE FDA DOES ALL THE TIME.
Read the whole thing! I actually had to read it in several sessions, it’s not that long but bouts of anger interspersed with moments of laughter made me have to put it down momentarily to recover. There is a lot more in the post on reforms.
Best quick intro to my views on the FDA is this post (follow the links) and my paper on off-label prescribing.
Addendum: Scott updates the infant fish oil story and provides much more detail. He got some things wrong and the FDA as an agency ends up looking better but the broad outline about the FDA system looks right. I am leaving the post up for posterity but this specific part isn’t correct.