Here's a question I've been mulling in recent months: Is Alex Tabarrok right? Are people dying because our coronavirus response is far too conservative?
I don't mean conservative in the politicized, left-right sense. Tabarrok, an economist at George Mason University and a blogger at Marginal Revolution, is a libertarian, and I am very much not. But over the past year, he has emerged as a relentless critic of America's coronavirus response, in ways that left me feeling like a Burkean in our conversations.
He called for vastly more spending to build vaccine manufacturing capacity, for giving half-doses of Moderna's vaccine and delaying second doses of Pfizer's, for using the Oxford-AstraZeneca vaccine, for the Food and Drug Administration to authorize rapid at-home tests, for accelerating research through human challenge trials. The through line of Tabarrok's critique is that regulators and politicians have been too cautious, too reluctant to upend old institutions and protocols, so fearful of the consequences of change that they've permitted calamities through inaction.
Tabarrok hasn't been alone. Combinations of these policies have been endorsed by epidemiologists, like Harvard's Michael Mina and Brown's Ashish Jha; by other economists, like Tabarrok's colleague Tyler Cowen and the Nobel laureates Paul Romer and Michael Kremer; and by sociologists, like Zeynep Tufekci. But Tabarrok is unusual in backing all of them, and doing so early and confrontationally. He's become a thorn in the side of public health experts who defend the ways regulators are balancing risk. More than one groaned when I mentioned his name.
But as best as I can tell, Tabarrok has repeatedly been proved right, and ideas that sounded radical when he first argued for them command broader support now. What I've come to think of as the Tabarrok agenda has come closest to being adopted in Britain, which delayed second doses, approved the Oxford-AstraZeneca vaccine despite its data issues, is pushing at-home testing and permitted human challenge trials, in which volunteers are exposed to the coronavirus to speed the testing of treatments. And for now it's working: Britain has vaccinated a larger percentage of its population than the rest of Europe and the United States have and is seeing lower daily case rates and deaths.
Many of these policies could still help America and the world — particularly with the more contagious, and more lethal, B.1.1.7 variant spreading. Just this week, Atul Gawande, who served on President Biden's Coronavirus Task Force, endorsed delaying second doses in order to accelerate initial vaccinations and slow the rise in cases. But there's no evidence that the FDA, the Biden administration or global health authorities are any closer to doing so. At this point, it's worth asking why.
At the core of this debate sit two questions: How much information do regulators need to act? And how should regulators balance the harms of action against the harms of inaction? The FDA's critics feel the agency demands too much information before it moves and is too comfortable with the costs of not making decisions, even in an emergency. "Not doing something is a choice," said Emily Oster, a health economist at Brown. "It's not a safe harbor."
Daniel Carpenter is a professor of government at Harvard, and an expert on the FDA, and he thinks its critics underestimate the costs of a mistake. "Effective therapies depend upon credible regulation," he told me. Mass vaccination campaigns work only if the masses take the vaccines. "In this way, it's a deeply social technology, and so the credibility is everything."
To Carpenter, the FDA's critics miss the consequences of regulators losing public trust. President Donald Trump publicly pressured the agency to authorize unproven drugs, like hydroxychloroquine, that proved useless and tweeted that the "deep state" in the agency was trying to delay a vaccine to hurt him politically. Stephen Hahn, then the FDA commissioner, joined Trump at a briefing to tout an emergency use authorization for convalescent plasma — and Hahn then had to apologize, and fire two staff members, after misstating the evidence. It looked, to many, as though the FDA's process was collapsing under Trump's attacks.
A result was that from August to September, the share of Americans who told Gallup they were willing to take a vaccine fell from 62% to 50%, and among Democrats it fell even further, from 79% to 53%. Further polling showed that fears of a rushed, unsafe vaccine were driving the drop. It took months, and a series of stringent process announcements by the FDA making clear that it would not be bullied into an early authorization by Trump, for confidence to recover. This, for Carpenter, is what the FDA's critics don't understand. "Therapeutic credibility is the entire ballgame here," he said.
Let's grant that Trump put the FDA in an impossible position and hurt the vaccine rollout. The more reckless and politicized he publicly urged it to be, the more careful and conservative it had to be to maintain credibility. But Trump's behavior doesn't explain the morass the FDA created over testing.
"Testing has been a problem throughout the pandemic," Eric Topol, the founder of the Scripps Research Translational Institute, told me. "We had no tests for six weeks, maybe two months. That's what led to the wide spread of the virus in February and March." That was an FDA failure, he says, perhaps its most consequential. When I spoke with him on Monday, the FDA's sluggishness on testing was still a problem. "Not one damn cheap, at-home, 15-minute test has been approved in a year!" Topol said, his voice rising.
The good news is that the FDA has changed its mind. On Wednesday night, the FDA authorized a number of cheap, rapid, at-home tests. This follows the news that the Centers for Disease Control and Prevention is launching an at-home testing pilot program in Tennessee and North Carolina. But all of this could, and should, have happened months ago. Mina, who has led the charge on at-home testing, told me that the FDA has demanded too much certainty, given the scale of the crisis, and it has been too loath to permit reasonable experiments. "One of the best pieces of advice I ever received was 'When you're making a tough decision, remember decisions are temporary,'" he said. "We can try it. If we see data that suggests it's not working, we can retreat and try something new. Our policymakers make decisions as if they have to stick with them. That's one of the most destructive dynamics in this pandemic."
The same tensions have held up efforts to alter vaccine dosing in ways that would increase supply. There's good evidence that the first doses of Pfizer and Moderna provide significant protection, and so delaying second doses — as Britain is doing — could allow us to vaccinate more of the population, and get to herd immunity faster. There's also research suggesting that half-doses, or some other fraction, might be plenty to trigger an immune response.
Biden said he will "follow the science," but that often means following the existing evidence, which is not the same thing. It's wrong to assume that the dosing protocols that pharmaceutical companies proposed in their rush for authorization are optimal for society's goals. "They wanted to get this going as soon as possible, so they didn't explore other doses, and it's very likely they overdosed the vaccine," Topol said. There is, of course, a risk in attempting a dosing protocol that didn't go through Phase 3 trials; perhaps immunity will fade faster, for instance. But holding to the current dosing schedules means a slower vaccination program and more deaths.
In all of this, the same issue recurs: What should regulators do when there's an idea that might work to save a large number of lives and appears to be safe in early testing but there isn't time to run large studies? "People say things like, 'You shouldn't cut corners,'" Tabarrok told me. "But that's stupid. Of course you should cut corners when you need to get somewhere fast. Ambulances go through red lights!"
One problem is no one, on either side of this debate, really knows what will and won't destroy public trust. Britain, which has been one of the most flexible in its approach to vaccines, has less vaccine hesitancy than Germany or the United States. But is that because of regulatory decisions, policy decisions, population characteristics, history, political leadership or some other factor? Scientists and politicians are jointly managing public psychology, and they're just guessing. If a faster, looser FDA would lose public trust, that's a good reason not to have a faster, looser FDA. But that's a possibility, not a fact.
"My view is this was all psychology which no one really understood, so I just said, 'Go with the expected value. Do the thing that'll save the most lives and stick with it,'" Tabarrok said. "That's a better rule than trying to figure out 'If I do this, what will someone else do?'"
One thing I came to believe, reporting this column, is that politicians have too often hidden behind regulators. For much of the pandemic, Trump had no plan at all, and so the decisions of governors and regulators were paramount. Biden is doing much more, but he's said, repeatedly, that he doesn't want to get ahead of the science. Unfortunately, science can't tell you what it does not yet know, and the virus spreads faster than our knowledge. It's the job of politicians to weigh the information we have, and the possible benefits of experimentation, against society's broader goals.
The good news is we know more now than we did a year ago. "We got really lucky," Gregg Gonsalves, an epidemiologist at Yale, told me. "These were incredibly potent vaccines. If things were on the margins, we'd be a lot more uncomfortable right now about what we're doing." It's an important point. Regulators have seen medicines fail, sometimes in lethal fashion. They would have to live with the consequences of a decision gone terribly wrong, in ways that their critics would not. But we did get lucky. And so there may be policies that looked risky six months ago, or fantastical a year ago, that we can, and should, consider now.
When I asked Tabarrok what his agenda was now, much of it was the same. "The variants come from the unvaccinated," he said, so we need to finish vaccinating Americans and do everything in our power to accelerate vaccinations in the rest of the world. Everything he's argued for in America applies globally: First doses first, run challenge studies to see if half-dosing or fractional-dosing works, pump money into vaccine supply.
To Tabarrok, vaccines have shown themselves to be so valuable that it's simply absurd that we wouldn't do everything possible to be fully equipped for mass vaccination campaigns in the future. Florian Krammer, a microbiologist, has proposed developing and testing vaccines for all of the respiratory virus strains that are plausible drivers of future pandemics. Tabarrok backs that plan.
And to make sure we could then produce those vaccines at scale, Tabarrok brought up an idea that came from the Biomedical Advanced Research and Development Authority when Rick Bright was its director. The authority proposed subsidizing the construction of private manufacturing facilities as long as the government has the authority to take them over in times of pandemic.
If all of this sounds as if it'll require a lot of government action, well, it will. "Ninety-nine years out of 100, I'm a libertarian," Tabarrok said with a laugh. "But then there's that one year out of 100."