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America's inflexible public health institutions
We've changed a lot to cope with the pandemic, but the institutions charged with protecting us have stayed rigid
I’m a guy with a lot of takes and a lot of strongly held opinions, but I feel weirdly indifferent to the whole mask debate. When I was in Texas where nobody wears masks, I didn’t wear one either and thought it was fine (I’m vaccinated). But now I’m back in D.C. where the rule is you need to wear masks inside, and that’s fine too. Honestly, if you made masks mandatory forever in grocery stores with the stated goal of reducing the spread of the common cold, I wouldn’t really mind. But we could also all ditch masks forever and I’d be fine with that (again, I’m vaccinated).
As a contentious person with a lot of opinions, I honestly feel weird not having strong feelings about such a hot button issue of our times. But that’s how I feel — nothing.
Where I do have strong feelings, though, is that I observe the public health community asking everyone to show a lot of flexibility with regard to this whole mask thing. It’s not normal American practice to be wearing masks. And people don’t like to deviate from their normal routines. The idea is that the Covid-19 pandemic is a big deal such that people should be willing to show more flexibility than they normally would.
And that’s a very reasonable idea. But what’s been sticking in my craw for months is the extent to which America’s public health institutions themselves have shown so little flexibility during this crisis even as they see the virtue of flexibility in everyone else’s behavior.
Moderna’s vaccine still isn’t fully approved
David Leonhardt did a good piece on Tuesday laying out the case that the FDA not moving quickly enough on full authorization for the Pfizer vaccine likely led to thousands of deaths.
Now whenever I bring this up, someone quickly wants to push the conversation in the direction of social psychology. The anti-vax nutters would go crazy if the process were rushed. The skeptics would still be skeptics. And that’s maybe all true. But my basic point about this is simpler: if an unvaccinated person were to say tomorrow he’d like to get vaccinated, but he doesn’t want to drive to the next town over, and the local pharmacy only has Moderna, he’s not going to bother until things slow down at work. Then everyone on public health twitter would yell at him. Dr. Fauci would tell him to just go get the Moderna shot. That’s what I’d tell him too. And it’s what Joe Biden would tell him. Heck, it’s what Donald Trump would tell him.
The point is that the reason the Moderna vaccine should have full authorization is that nobody in any position of power or authority in the United States is expressing any doubt about the wisdom of taking the Moderna vaccine.
There is simply a mismatch between what their judgment says people should do and what the bureaucratic process says ought to happen. By choosing to subordinate their assessment of what people should do (take the damn shot!) to the strictures of the process (more time needed!), they are demonstrating a form of stubbornness and inflexibility.
This is bad not because of its impact on anti-vaxxers or skeptics, but because of its impact on other inflexible bureaucracies. The U.S. military routinely requires servicemembers to take vaccines — not only the standard vaccinations required by colleges but even annual flu shots. Yet when Covid vaccines first became available, the military did not require them. Indeed, vaccine uptake among military service members has been fairly low. Having discussed this with a few officers, including a military doctor, a few points emerge:
The enlisted troops skew young, male, and non-college, which are all demographic groups that skew toward being less cautious about Covid, so naturally you have some problems with uptake.
The military is very much a professional culture that emphasizes courage in the face of danger, so people with an objectively low risk profile taking a vaccine they “don’t need” may be seen as cowardly.
The military routinely requires vaccinations, so making a vaccine optional suggests a lack of confidence in the vaccine that is unnerving.
If you mandate the vaccine, then you’re not getting the vaccine because you’re afraid; you’re getting it because it’s mandatory. And you may not agree with the decision, but you’re in the military and you get ordered to do stuff you don’t particularly want to do all the time.
And the good news is the military is now going to mandate vaccination. But they’re only doing it now because the Defense Department's view was that they can’t mandate an EUA vaccine. And the FDA’s view was they couldn’t give Pfizer non-emergency authorization. And then lots of other American institutions looked at the Pentagon and decided that if the military felt a mandate would be illegal or inappropriate, who were they to become more authoritarian than the military? Now as it happens, the dam started to break on non-military mandates about a month ago which was great to see. And as far as I can tell, every major public health figure agrees that vaccine mandates were good. But we could have started rolling out mandates back in May or June when the supply crunch went away. We didn’t because institutions throughout American society were deferring to the DOD lawyers, who were deferring to the FDA, who were deferring to the vaccine licensing procedure.
Which is all totally understandable human behavior. Unfortunately, tons of people died as a result. It is, to me, a precisely parallel tragedy to what unfolded last December when tons of families were unwilling to delay their traditional family Thanksgiving and Christmas gatherings — a very understandable human impulse — and tons of people died as a result. Most people in the public health world, it seems to me, understand why the holiday season inflexibility was bad but don’t appreciate the harms done by institutional inflexibility.
Fractional doses and longer schedules
A media thing that drove me crazy back before the Johnson & Johnson vaccine went out of style was the habit of saying that the Moderna & Pfizer vaccines require two doses while J&J was a one-shot vaccine.
The way this actually works is that when you conduct a Phase III clinical trial, you need to say in advance what you are testing. Then you run the trial, you collect the data, and you submit it as evidence that your medication is safe and effective. That means the pharmaceutical company needs to try to guess based on its prior research what kind of dosing regime will show positive results, and also what kind of dosing regime will be attractive in the marketplace and useful. The normal situation with vaccines is that you get an immune response with one shot, and also that immune response is enhanced with booster doses.
So J&J simply chose to design a one-shot clinical trial while the mRNA companies designed trials based around a two-shot regime. When the data came back, it said that one J&J shot was effective but that two mRNA shots were even more effective.
But just because a trial was conducted a certain way doesn’t mean we have to slavishly imitate it. A number of countries, including most relevantly our neighbors to the north in Canada, responded to the early shortage of mRNA doses with a “first doses first” approach. The way this worked is that they lengthened the space between the first shot and the second shot to four months to maximize the number of people who could get the protection of the one dose. Then they looped back around and gave everyone a booster. This took advantage of our scientific knowledge that one shot provides immune protection, and also that there was no experimental evidence whatsoever that the four-month delay was worse than the three-week delay in the clinical trial (indeed, a subsequent study from the UK suggests that the longer spacing might actually be more effective).
Canada, in other words, was flexible.
In part, that’s smart decision-making. In part, I think it reflects a different institutional culture. Canada has a single-payer health insurance system, and provinces operate within the context of a global budget cap. So Canadian health authorities’ day-to-day job is solving resource-optimization problems. In America’s much more profit-driven system, the regulators’ mission is to protect us from hucksters. But in a new context when America was facing a resource optimization problem, they didn’t display flexibility.
Relatedly, they continue to not recommend that people who got the Johnson & Johnson shot get an mRNA booster even though there is clear data to support that idea. The issue, as Leana Wen of the Milken Institute School of Public Health explains, is that nobody has done a specific safety trial on the mix-and-match. It is too bad that we don’t have ironclad experimental evidence on this, but as she says, “though the risk is theoretically unknown since this exact combination is still being studied, it’s almost certainly lower than the risk of severe illness were they to contract covid-19.”
A related issue is that half-doses of the Moderna vaccine appear to be much more than half as effective as a full dose. That could have been used to speed vaccination during the U.S. supply crunch (recall that the deadliest phase of the pandemic came in the winter of 2020-21, after vaccines were authorized but while supply was very scarce). It also could be used to ameliorate what health authorities currently perceive to be a stark tradeoff between booster shots for rich countries and first doses for poor countries. We could conceivably double supply by using half doses. But we’d need to be flexible.
I will also admit that all of these issues would benefit from more study. But that’s another way of saying we’d benefit from more flexibility on the research agenda.
Unresponsive science funding
At the beginning of the pandemic, Patrick Collison, the CEO of Strip, partnered with economist Tyler Cowen to create a program called Fast Grants that aimed to give scientists grants really fast.
Here is a slightly faux naive tone, they explain why a new initiative for this was necessary:
As the first U.S. lockdowns commenced in March last year, we reached out to various top scientists, and were surprised to learn that funding for COVID-19 related science was not readily available. We expected the U.S.’s immense government funding systems to be unleashed, with decisions made in days if not in hours. This is what happened during World War II, which killed fewer Americans.
Instead, we found that scientists — among them the world’s leading virologists and coronavirus researchers — were stuck on hold, waiting for decisions about whether they could repurpose their existing funding for this exponentially growing catastrophe. It’s worth visiting the National Institutes of Health (NIH)’s application overview for this, launched in March 2020, to get a tangible sense for what those seeking emergency funding were facing.
I think even in a utopian world of optimal government there would still be a utility for something like Fast Grants. A large public sector entity is never going to be as nimble or as daring as an idealistic young rich guy partnering up with a few of his favorite scholars. And that’s fine; it’s one of the reasons why it’s good to have a philanthropic sector and not just a government.
But even in a world of realistic expectations, we just have seen very little effort to pivot the country’s science funding apparatus in a nimble way toward high-value projects.
Just keeping the focus on vaccine stuff, we’ve treated it essentially as a totally normal drug approval situation. The pharmaceutical companies are expected to pay for the clinical trials, so they don’t want to do anything beyond what’s necessary to sell the product. The regulators look at the data they are handed and make decisions within the four walls of the trial. If provocative research comes in suggesting we should maybe be halving Moderna doses but the sample size happens to be small, nobody hustles to go do an experiment with a larger sample size. And I get the sense that based on the way academic career incentives go, something like that wouldn’t be considered a prestigious undertaking worth spending your time on anyway.
Then there are tons of other questions about acquired immunity in recovered Covid patients, about the efficacy of different kinds of masks, the utility of HEPA filters, etc. where the quality of the evidence just isn’t that good. A lot of what we talk about these days is based on studies from Israel and the UK because the American government hasn’t really been setting up big studies. If you eyeball the numbers in the highly vaccinated states, it sure looks to me like there’s got to be a decent number of vaccinated people who are getting some kind of low-level Covid infection. But there’s no place in the country that’s trying to do randomized surveillance testing to assess the level of asymptomatic or barely-symptomatic cases, and there never has been.
Change is hard
I appreciate that I am glossing over a lot of details here.
For the NIH to reallocate funding more nimbly might require a new act of Congress. On the other hand, Congress did pass some pretty dramatic legislation in response to the Covid pandemic. Oftentimes in government people can’t do something that seems sensible because their hands are tied by the rules. But oftentimes people implicitly like having their hands tied by the rules because it lets them off the hook personally. A school district saying it can’t mandate vaccines and pointing to the Department of Defense which points to the FDA where the commissioner points to the established process is not a functional way to run society.
But for Janet Woodcock or Lloyd Austin or Joe Biden to put themselves out there would be a risk. And it’s easier to stick with the system.
This is where I’m back to the fact that I’ve had my life turned upside down by Covid-related protocols and I don’t even feel like I’m in the top half of people who’ve had their lives impacted by Covid-related protocols. I’ve seen teachers working in-person mid-pandemic while also trying to serve kids learning remote. Restaurant owners who’ve had to pivot to takeout business models. Parents with service sector jobs that can’t be done remotely who’ve had to deal with schools that are “open” but not on Wednesdays. The movie industry totally changed its distribution model. Live music went away altogether.
And I tend to agree with the public health consensus that significant segments of American society did not demonstrate enough flexibility during this pandemic. But honestly, there has been a lot of flexibility! Yet very little of it has come from the health agencies.
It really makes me worried about the next pandemic. As events have unfolded, I think daily conditions have become a lot more tolerable. I’m vaccinated. My family is vaccinated. We own lots of masks. All the little kids I know are fine with wearing them. Restaurants have more outdoor seating than they used to. I’m accustomed to recording podcasts over Zoom now. Life goes on. But I haven’t seen the public sector institutions we rely on getting any more nimble even though we are aware that the situation will keep changing, and wherever Covid came from, we haven’t stopped new viruses from emerging.