Why the U.S. pandemic playbook was no match for COVID

COVID-19 deaths and cases are starting to decline and some experts are projecting that the worst of the delta surge is over, thanks to a combination of vaccine uptake and natural immunity.

However, recent experience warns against complacency. This (not-so-novel-anymore) coronavirus and its variants have wreaked havoc and could continue to.

And the country urgently needs to upgrade its pandemic response capabilities to prevent future infectious calamities, argues former Food and Drug Administration Commissioner Scott Gottlieb.

In his new book, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic, Gottlieb revisits the federal response to the COVID-19 crisis from his post-government perch as a health care venture capitalist, media commentator and member of Pfizer's board — the company that launched one of the first safe and effective vaccines against COVID-19.

Along the way, he recounts the science, the policies, the successes and notable failures in our country's pandemic preparation — and makes a strong case that we need to already be planning ahead for more pandemics.

Gottlieb helmed the FDA from 2017-2019, leading the agency through policy battles over electronic cigarettes and the opioid epidemic. When the pandemic started, he worked with other public health experts to cull the evidence and make recommendations to the White House Coronavirus Task Force.

This interview originally aired on Public Radio Tulsa's Medical Monday. It has been edited for clarity and length.

You had a front row seat to many of the policy decisions that were made, or in many instances, not made early in the pandemic. Why do you think, for example, we failed to quickly implement widespread COVID-19 testing?

A big problem was we were playing off of our standard approach to rolling out a diagnostic test in a public health emergency, without recognizing that we were in a fast-moving epidemic where diagnostic testing was going to be essential. This has the CDC maintain tight control over the tests and the testing — rolling out a test, initially running the tests, then rolling it out to the public health labs. And if that isn't sufficient to keep up with public health demand, you would make it available to the clinical laboratories such as academic hospitals. And if that still isn't enough, you turn to commercial manufacturers to ramp up testing.

Once the CDC finally had a test designed, we got behind the eight ball early by not having enough testing in place to diagnose the early cases. And by the time we had testing in place, it was too late. The virus was everywhere, and we weren't going to be able to use testing as a tool to try to contain the spread.

Why is the "standard playbook" so slow?

Part of the problem is that our pandemic playbook always envisioned that a pandemic would be caused by influenza. And in the setting of influenza, having a diagnostic test widely deployed isn't as important for one reason — because the incubation period for flu is shorter. Patients come into contact with flu and get sick in a much shorter period of time, and they're usually not contagious until they're infectious. So diagnosing people when they're asymptomatic and carrying the infection isn't as important in the setting of controlling a flu as it is for a coronavirus.

You were asked to brief President Trump early in the pandemic. What do you think he did right in the pandemic response, and where did he fumble?

I met with the president right before they announced the "15 days to slow the spread" and then another 30 days to slow the spread of the virus. People have been critical of the president and say he didn't take this seriously, and forget that early on the president agreed to a 45-day shutdown, a national shutdown. I mean, an extraordinary decision, right? So that's an indication that they were sufficiently alarmed by the grave risk that this posed that they were willing to take dramatic action.

Where I'm critical of the administration is that I think we didn't stick with it. This was going to be a long fight and we had to have a plan for dealing with this as a pervasive risk. That didn't mean shutting down the country for a year — that wasn't on the table, but we needed to find some way to put downward pressure on the spread until we could get a vaccine.

I think by the end they had given up on a lot of these simpler interventions like wearing masks, or reducing high risk activities in high risk settings. We never really came together around a commonly agreed upon set of measures that we could take. We could have used the bully pulpit of the White House to get common action around a common set of ideas.

In the book you explain some of the ways the U.S. has tried to plan ahead for future pandemics. For one thing, we have a strategic chicken stockpile. Is that still true, and what is it for?

Yeah, it's still true. It's less secretive now than it was at one point. This comes out of the pandemic planning around 2005, when we were planning for the risk of a pandemic with an avian flu — H5N1 flu. And there was concern that in the setting of a pandemic flu, you either wouldn't have enough eggs to manufacture vaccines or the chickens themselves that lay the eggs would be decimated by the strain of flu.

As many people probably know, flu vaccine is manufactured in chicken eggs. What you basically do is use a chicken egg where there is a developing chicken embryo to grow the influenza virus, and then you harvest the virus out of the chicken egg and make the vaccine. So as a hedge against an avian flu that would either decimate the chicken flocks around the country or overwhelm our supply of eggs, we created this strategic stockpile of chickens that was sequestered in carefully maintained facilities, so you'd always have a supply of chicken eggs. And we maintain that as a strategic hedge against pandemics. So there was a lot of pandemic planning that went on. It just focused around flu.

You offer an example of how the U.S. pharmaceutical manufacturing sector could prepare for the next pandemic. In the book you describe how Hurricane Maria hit Puerto Rico in 2017 and caused major disruption to pharmaceutical manufacturing. Yet there was one facility run by the pharma firm Amgen that continued manufacturing without interruption. What does it teach us about planning ahead for crises?

First of all, this facility was operating at full tilt. I mean, they had the generators to back up their generators. They had enough fuel on hand to operate for months off the grid. And so I asked the obvious question [of CEO Bob Bradway]: Why did you build this exceptionally hardened facility?

And his answer was, "We made an implicit guarantee to the federal government that there would never be an interruption in the supply of Neupogen," which was a drug they made there. Neupogen is used to reconstitute white blood cells, typically after chemotherapy. But if there was ever a radiological attack and people had their bone marrow poisoned by radiation, you'd also need a lot of Neupogen to help rescue people from the radiation poisoning. And as a strategic hedge against that contingency, the federal government paid Amgen some explicit amount of money to build these exceptional facilities.

That's an illustration of the kind of planning that needs to go into place as a hedge against a pandemic. We need to pay for some residual capacity in the current system. We can't just build plants and mothball them. We need to keep them hot. We need to keep them operating.

The example I use is a high-complexity diagnostic lab that may operate 3,000 PCR machines at 80% capacity. That's maximal efficiency. You can't operate them all the time. You need some downtime, maybe having 5,000 machines and operating them at 50% capacity. So now you have a surge capacity available. Someone's going to need to pay for that residual capacity because it's expensive. So that's when the government can come in and pay for some residual capacity as a strategic hedge against a bad outcome like a pandemic.

You make the case for a forecasting service along the lines of the National Weather Service to use strategic data insight so we're not caught off guard by another pandemic. Do you think we'll get there? Will we be more prepared next time?

I hope we will. I mean, the book is my attempt to start to stimulate a discussion about what we need to do to be better prepared and hardened against these contingencies in the future. I think that there's going to be a more fundamental debate that needs to precede the debate around how we prepare for the next pandemic, and that is the debate around what is the role of public health. I think that in order to be properly prepared for the next pandemic, we're going to need to empower public health agencies. We're going to need to build new capacities at CDC and empower them to act in a public health crisis of this magnitude in the future.

I think that there's skepticism of public health right now. And this isn't just sort of a right-left debate, conservative vs. liberal. I think it's more pervasive than that. And so we need to have a fundamental discussion about what the role of public health is. How do we reform the process by which public health advice gets generated and disseminated and arrive at a consensus around the appropriate role for public health agencies that hopefully vests in them the authority that they need to exercise the role that they're going to have to play in a public health crisis.

John Henning Schumann is a doctor and writer in Tulsa, Okla., where he hosts StudioTulsa's Medical Monday for KWGS Public Radio Tulsa.

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