Month: August 2021

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 f@$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.

How many children are killed by the schools anyway?

That is the topic of my latest Bloomberg column, here is one excerpt:

Of course, with or without Covid, some number of children die at school. But it is surprisingly difficult to find out how many. In 2020, there were more than 50 million students in public elementary, middle or high schools, yet there is no systematic national database of student deaths at school. School shootings have claimed up to 75 deaths annually in recent years, and there are many other possible causes of death, such as traffic or sports accidents.

It’s entirely plausible that a few hundred students die each year for reasons directly related to school attendance. If suicides induced by school bullying but occurring off campus are included, the number could be higher still. Some 4,400 young people in America commit suicide in a typical year, and surely many of those deaths are attributable, at least partially, to events at school.

Adding up all these admittedly indirect chains of causation, it’s possible that school attendance leads to at least 2,000 deaths every year in the U.S. And those have nothing to do with Covid.

Fortunately, it is not customary in normal times to debate whether it is worth opening schools knowing that it could result in the death of perhaps 2,000 students. The true toll of opening schools is unknown, much less debated, and if there is a discussion it is over school shootings, which ought to be preventable (or at least limited) by measures other than closing schools.

This “head in the sand” approach is highly imperfect. Still, it is preferable to panicking and closing the schools every year.

It is difficult to calculate how many children have died of Covid, but perhaps the best estimate comes from England, where it caused 25 deaths of people younger than 18 in the year ended in March. The final tally is certainly higher in the more populous U.S., but as of July seven states still were reporting zero Covid deaths among children. This recent estimate suggests 358 deaths, though it is based on only 43 states.

Yes, it is worth considering whether school reopenings will lead to unacceptably high levels of Covid in the non-school population. It is also worth pointing out that Covid is spreading very rapidly in states with low vaccination rates — without the schools playing a role. In any case, it does not justify focusing solely on the safety of children in discussions of school reopening.

Economists have long studied the tendency of people to assign more value to a “known life” than to a “statistical life.” When a baby is trapped down a well, for example, many millions of dollars will be spent trying to save her. Her photo will appear on the evening news and on social media. Yet when it comes to saving lives in the aggregate, such as by installing more and better smoke detectors, there is only modest interest.

Right now too many Americans are trapped: Because the pandemic has been so dramatic for so many, every life looks like a known life rather than a statistical life. We all need to start working our way back to a bit more emotional distance.

Recommended.

That was then…

Here is an excerpt from Arthur Moeller van den Bruck, the guy who coined the term “The Third Reich” (hint: he wasn’t against it):

The Left has reason.  The Right has wisdom…Masculinity is the essence of wisdom.  It takes character not to succumb to self-delusion.  The conservative man possesses this character as well as the physical prowess and moral determination to act in accordance with this character…He has the innate ability to pass judgement, and to make deductions, to recognize reality…Conservatism is based on an understanding of human nature.

That is from the new and excellent book Nazis and Nobles: The History of a Misalliance, by Stephan Malinowski.  This book builds on themes from Arno Mayer’s old and excellent The Persistence of the Old Regime.

It is an interesting question why these sentiments — some of which are cliched rather than offensive per se — are as correlated with fascism as they are.  In my oversimplified model, feminization is the key variable.  Van den Bruck saw the feminization of society coming, and opposed it, but I believe he was more interested in Nazism and fascism per se.  Many current commentators also oppose that feminization virulently, and that leads them to take up with strange and rather unfortunate bedfellows, namely fascists, as fascists do in fact have modes of discourse for opposing or criticizing feminization.  Often fascism per se is not the main interest of today’s right-wing thinkers, and if you started lecturing them on Speer’s building plans for Berlin, or earlier German cartel policy, their eyes would glaze over.  They are more interested in the current cultural wars, but they don’t always have the intellectual equipment to fight them, and so they look to fascists, a badly mistaken choice.

I say feminization is here to stay, we need to find workable versions of that — how’s that for a challenging intellectual project?  Those of us looking backwards to “the nasty people” are going to find themselves staring down a dead end, intellectually and otherwise.  Hungary and Salazar are not the future, people.  You should be jumping on better bandwagons, or if need be building them yourselves.

The Most Important Act of the Last Two Decades?

A good case can be made that Project Bioshield is the most important piece of legislation passed in the last twenty years. Passed under President Bush in 2004, Project Bioshield’s primary goal was to create advance market commitments to purchase countermeasures for chemical, biological, radiological or nuclear agents (CBRN). Several billion dollars have been spent in this area promoting anthrax and smallpox vaccines and various antitoxins for botulism and nuclear threats. The record on these advance market commitments is mixed with some notable failures.

The second thing the act did is to reduce some paperwork requirements on purchases and research funding. Those seem fine although the simplified procedure is itself too complex and the amounts such simplified procedures apply to are too small, e.g.

The Project Bioshield Act authorizes the HHS Secretary to use an expedited award process for grants, contracts, and cooperative agreements related to CBRN countermeasure R&D Activity, if the Secretary deems a pressing need for an expedited award exists. The authority is limited to awards of $1.5 million or less.

The third aspect of the act was not considered a big deal at the time but is the one that has proved to be the most important. Project Bioshield created the Emergency Use Authorization (EUA). In other words, prior to 2004 the FDA had no clear legislative authority to authorize an unapproved vaccine, drug or device. Without Project Bioshield and the EUA procedure the FDA might have eventually found some way to authorize vaccines before full approval. Britain, for example, used a temporary authorization procedure. Or the FDA might have sped up full approval but given the FDA’s lethargic record it’s easy to imagine that this would have taken months longer than the EUA process. As a result, the EUA procedure created by Project Bioshield probably saved 100,000 or more lives.

Important Addendum: It’s also worth mentioning that the EUA procedure doesn’t just apply to approvals it also allows changes in dosage and labeling. Susan Sherman, the senior attorney with the HHS Office of the General Counsel, noted in 2009 that a drug that had been approved for individual health in a non-emergency might have to be used very differently for public health in an emergency and that the EUA process could be used to adjust to these differences:

“You can change the labeling. You can change the information. You can change the dosage. You can give it to populations for which wasn’t approved.” She continued, “In some sense we had to match up in practice a public health response where you might not have the precise labeling that your physician would prescribe to you. There are a lot of variables that are necessary for the public health responders that don’t necessarily match what the approved drug would look like if you just went to your physician and got it because you had that illness.

In other words, the EUA process was made to allow for procedures such as fractional dosing. It’s too late for fractional dosing in the United States (but we should use it for boosters) but fractional dosing remains a vital tool to deal with the global shortage of vaccines.

“My favorite things Hungary” — my revisionist take

Way back in 2011, when I was visiting Hungary, I did a post in typical MR style: My Favorite Things Hungary.  I had no particular political point in mind, and indeed the current disputes over Hungary did not quite exist back then.  Nonetheless, if you survey the list, just about every one of my favorites listed ended up leaving Hungary.  The one exception, as far as I can tell, is film director Béla Tarr, but he is a critic of both nationalism and Orban.

All the rest left Hungary.

And while I cannot give you exact numbers, a large number of them were Jews or half-Jewish, hardly examples of Christian nationalism.

You should note that Hungary has a longstanding tradition of flirting with fascism and indeed going beyond mere flirting, for instance as exemplified by the Horthy government of the interwar years.

Once you get past all the polemics and name calling (not to mention the reality), here is the lesson I draw from the current debate over how parts of the Right are embracing Hungary.  It is genuinely the case that liberal societies often draw upon less liberal societies for a good deal of their cultural vitality, most notably the United States recruiting various creators from Central Europe — including Hungary — during the 20th century.  (Or the blues drawing some of its depth from the history of slavery.)  That point should be appreciated, even though we all should recognize it is not worth Hungary’s history, including its feudal and conquered past, for being able to say your country produced Bartok and Solti.

The current Hungary, sadly, has nothing remotely like the Hungarian cultural blossoming that ran from Liszt through Ligeti.  Instead it is giving us an empty huff and puff of rhetoric, “owning the Libs,” having “the right enemies,” gender role polemics, and so on.  It is not producing great buildings like the Budapest of times past, and it is not developing a significant Christian tradition of the sort that might have marked the 19th century Hungarian Church (however you might feel about that, I can tell you it is not my thing, though I can appreciate the liberal elements in it).

These days we have a U.S. television show host visiting Hungary and serving up thin polemics which are then debated on Twitter.  There is only a thin veneer of culture behind the whole thing, and a lot of unearned borrowing against earlier Hungarian creative traditions.

Don’t fall for it.  If you wish to respect Hungarian culture, listen to Bartok’s “Out of Doors” [Im Freien], or Liszt’s Transcendental Etudes.  What is there now is the straggling remnant of a cultural destruction led by both fascists and communists.  Current commentators can spin the current situation all they want, but it hasn’t worked out for the better, and Hungary is lucky to be in the EU at all.

Even American cultural borrowing from Central European traditions peaked some time ago.  George Szell brought Beethoven to the Cleveland Orchestra in 1946, and it was adored and financially supported by conservative Midwestern businessmen, as it should have been.  Szell passed away in 1970.  Ligeti himself stretches improbably late into Hungary’s cultural golden run.

If you think the current right-wing Hungary fandom is going to restore or revitalize either Hungarian or American culture, there is a bridge I would like to sell you, the Széchenyi Chain Bridge in fact…

Wednesday assorted links

1. How time use changed during the pandemic.

2. My short review of Green Knight.

3. Barbie doll of Oxford vaccine maker.

4. “Tennessee has sent nearly half a million dollars to farmers who have vaccinated their cattle against respiratory diseases and other maladies over the past two years.  But Republican Gov. Bill Lee, who grew up on his family’s ranch and refers to himself as a cattle farmer in his Twitter profile, has been far less enthusiastic about incentivizing herd immunity among humans.”  Link here.

5. “Five parrots separated at UK zoo after encouraging each other to swear at guests.”

6. The new Chris Blattman book on war is available for pre-order.

Status Quo Bias

Here is the lead sentence from a CNN piece on vaccine boosters:

Even though the biopharmaceutical company Pfizer has announced that it might be time to consider giving a third dose of its coronavirus vaccine to people, many doctors and public health officials argue that it’s more beneficial to get shots into the arms of the unvaccinated right now than to boost those who are already fully vaccinated.

Delaying the 3rd dose to get out more 2nd doses is a perfectly reasonable position. What’s interesting is that today delaying the 3rd dose is conventional wisdom and yet this is exactly the same argument that I made for delaying the 2nd dose, i.e. first doses first (FDF), back in December of 2020. At that time, however, the argument was controversial. My point, isn’t that FDF has won the argument. My point is that what we are seeing, then and now, is status quo bias.

In December, status quo bias meant that people wanted to find a reason to stick with the status quo, i.e. 2 doses, and so they argued that delaying the second dose was “risky.” Today, people still want to stick with the status quo and so they argue that third doses are “risky”, i.e. delaying the third dose is now the less risky idea. The argument–it’s smart to protect more people with fewer doses–hasn’t changed but, without even realizing it, people are now making the argument that they once denied.

The logic hasn’t convinced people but previously the logic opposed the status quo and now it supports the status quo so what was once denied is now accepted. What was in December the riskier choice now becomes the safer choice. With motivated reasoning, when the motivation changes so does the reasoning.

Hat tip: Iamamish

Addendum: People will respond in the comments, but actually the situations are different. Indeed, things are different and the situation has changed. But that’s not the only or even the primary driver. If we had started with a 3-dose regimen, delaying the third dose would have seemed just as “risky” as delaying the second dose in a 2-dose regimen.

Addendum 2: The WHO today called for a moratorium on boosters until more countries are vaccinated.

What should I ask David Salle?

Yes, the famous painter, I am slated to do a Conversation with him.  Here is the beginning of his Wikipedia page:

David Salle (born September 28, 1952; last name pronounced “Sally”) is a Pictures Generation American painter, printmaker, photographer, and stage designer. Salle was born in Norman, Oklahoma, and lives and works in East Hampton, New York. He earned a BFA and MFA from the California Institute of the ArtsValencia, California, where he studied with John Baldessari. Salle’s work first came to public attention in New York in the early 1980s.

And he has written the well-known and excellent book How to See.  He directed the Hollywood movie Search and Destroy, starring Christopher Walken.  So what should I ask him?

What makes an interview podcast good or great?

A few people have asked me lately what makes for a good podcast.  Since my podcast is far from the most popular, and since most podcasts are not like mine, and do not (and should not) try to be like mine, perhaps I am not the right respondent.  Nonetheless I offered a simple formula:

A podcast really works when it is the dramatic unfolding of a story and mood between the guest and host.

Or expressed in other words:

What makes for a good podcast is the dramatic tension between the guest and host.

If you think of Russ Roberts at EconTalk, often “the story line” is something like “I am a Mensch and you are a Mensch, and we are going to talk this through together.”  In earlier times, it had more elements of “you are going to put forward some mainstream points, and I am going to push back with market-oriented economics.”

Many of the most famous podcasts are variants of: “We will pretend to be talking about something, but in fact we will exploring new visions of masculinity for a Woke and post-Woke world.”

The visual images and home pages associated with those podcasts are often so…manly.  The T-shirts!  The muscles!  It is also why those podcasts fail so badly at having significant numbers of interesting female guests, addressed on their own terms.

Many episodes of Conversations of Tyler are “I’m going to try to show people just how smart you are, but it will end up a wilder and more precarious ride than you might have thought.”  Occasionally a guest flunks the test (though they might still be smart).  Alternately, the podcast with Daniel Carpenter was the first episode of “Tyler gets upset at a guest, they really have at it!”

I called my podcast with David Deutsch “weird and testy” — that too is dramatic tension.  One listener tweeted: “Tyler’s delight at having a guest who doesn’t hedge or mealymouth is palpable.”  Few tweeted about the substance of the disagreements.

One woman wrote about it: “Without understanding everything he said, I find myself mentally stimulated & spiritually inspired. Such a purist, an idealist, a truth-seeker w/ religious zeal. Not religious myself, I could see myself eventually submit to his religion”

She meant Deutsch.

Some listeners enjoy how the guests are surprised and delighted by the questions.  With Alexander the Grate — the homeless guy — the question was how he would perform at all.  I thought he was excellent and very interesting, but there was real suspense leading up to that point.  “And will Tyler question him just like he does everyone else?”

Get the picture?  I’m not saying these listeners are indifferent to the content, rather they filter it through the unfolding story about the dialogical interaction.  I don’t know of any successful podcasts that violate this principle.

One reader wrote to me:

…some very few podcasts are high level professionals in the same field, with a lot of respect for one another, exploring the space and enjoying each other’s company, especially when effectively “meeting for the first time.” I feel like this is maybe on the order of 1-5% of podcasts I hear. Most podcasts I listen to are “just” very high quality interviews

My podcasts with Lex Fridman or Tim Ferriss would be examples of that, and there are plenty more out there without yours truly.

So, to use Hansonian rhetoric, “Podcasting isn’t about the podcast!”  If you are seeking to understanding a podcast, including your own, start by asking what the basic story line is.  Where the dramatic tension lies.  Do you have enough dramatic tension in what you are doing?  What is the actual reason why you are not attracting more quality guests of a particular kind?

I am not claiming comparable expertise, but to return to my own endeavors, they are most influenced by: Monty Python’s Flying Circus (especially the interview segments, which maintain remarkable dramatic tension), Seinfeld (wonderful ensemble work), Curb Your Enthusiasm (for how long can you keep people on edge?), and the TNT halftime show with Charles Barkley, Kenny Smith, etc. (what makes for a dramatic or memorable interjection?).  I doubt those are the right sources for your podcast, but perhaps you should look far and wide as well, rather than just listening to other podcasts.  Howard Stern is perhaps another useful source?

If they had had another season of Seinfeld, would Jerry have to have started (again) dating Elaine?  The dramatic stories in a podcast also need to change and evolve over time, and perhaps I will return to that topic in the future.

Inequality sentence fragments to ponder

…wealth inequality varies greatly across countries, and there is no clear correlation with countries’ levels of income inequality.

Sweden for instance has reasonable income equality but very high wealth inequality.  Many of the southern European nations are the opposite.

So which is it that matters?  Is it income inequality that matters when you wish to praise Sweden over the United States, but wealth inequality that matters when you wish to argue for a wealth tax?

By the way, the distribution of housing equity is a critical factor for understanding how income variables translate into wealth variables.

That is all from Fabian T. Pfeffer and Nora Waitkus.  Via the excellent Kevin Lewis.