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Former FDA chief Scott Gottlieb urges the US to prepare seriously for the next pandemic: gunfire

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Dr. Scott Gottlieb headed the Food and Drug Administration from 2017 to 2019. His new book discusses the successes and failures of the U.S. response and how to plan ahead for future pandemics.

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Drew Angerer / Getty Images

Dr. Scott Gottlieb headed the Food and Drug Administration from 2017 to 2019. His new book discusses the successes and failures of the U.S. response and how to plan ahead for future pandemics.

Drew Angerer / Getty Images

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

However, recent experiences warn against complacency. This (no longer so novel) coronavirus and its variants have wreaked havoc and could continue to do so.

And the country urgently needs to improve its pandemic response capabilities to prevent future infectious disasters, argues the former commissioner of the Food and Drug Administration Scott Gottlieb.

In his new Book, Uncontrolled Spread: Why COVID-19 Has Crushed Us And How We Can Beat The Next Pandemic, Gottlieb views the federal response to the COVID-19 crisis from his government post as healthcare venture capitalist, media commentator, and board member of Pfizer – the company that brought one of the first safe and effective companies to market Vaccinations against COVID-19.

Along the way, he tells the science, politics, successes and notable failures of our country’s pandemic preparation – and makes it clear that we need to plan ahead for further pandemics.

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

This interview was originally broadcast on Tulsa Public Radio Medical Monday. It was edited for reasons of clarity and length.

You had a front row seat on many of the policy decisions made, or in many cases not made at the beginning of the pandemic. For example, why do you think we failed to quickly implement widespread COVID-19 tests?

A big problem was that we were playing off our standard approach to introducing a diagnostic test in a public health emergency without realizing that we were in a fast-paced epidemic where diagnostic testing would be essential. This keeps the CDC in tight control of the tests and the tests – run a test, run the tests first, and then run it in the public health labs. And if that’s not enough to keep up with public health needs, you’d make it available to clinical laboratories like academic hospitals. And if that’s still not enough, contact commercial manufacturers to speed up the testing.

After the CDC finally came up with a test, we got past eight early because we didn’t have enough tests to diagnose the early cases. And by the time we finished testing, it was too late. The virus was everywhere and we couldn’t use testing as a tool to contain the spread.

Why is the “standard playbook” so slow?

Part of the problem is that our pandemic playbook always stated that a pandemic was caused by influenza. And with the flu, having a diagnostic test not so important for one reason – because the incubation period for flu is shorter. Patients come into contact with the flu and get sick in much less time, and they are usually not contagious until they are contagious. So diagnosing people who are asymptomatic and have the infection is not as important in fighting the flu as it is in fighting coronavirus.

You have been asked to brief President Trump about the start of the pandemic. What do you think he got right with the pandemic response, and where was he fumbling around?

I met with the president just before they announced “15 days to slow the spread” and then another 30 days to slow the spread of the virus. People have criticized the president saying he didn’t take this seriously and forgot that the president early agreed to a 45-day shutdown, a national shutdown. I mean, an extraordinary decision, right? So this is an indication that given the grave danger this posed, they were sufficiently alarmed to take dramatic action.

What I am critical of the administration is that, in my opinion, we did not stick with it. It was going to be a long struggle and we had to have a plan to deal with this ubiquitous risk. That didn’t mean closing the country for a year – that wasn’t on the table, but we had to find a way to pressure 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 environments. We never really got together to come up with a mutually agreed package of measures that we could take. We could have used the White House tyrant’s pulpit to take joint action around a common set of ideas.

In the book, you explain how the US has tried to plan ahead for future pandemics. For one thing, we have a strategic chicken herd. Is that still true and why?

Yes it is still true. It’s less mysterious now than it used to be. This comes from the pandemic planning around 2005 when we were planning the risk of a pandemic with avian flu – the H5N1 flu. And there were concerns that in a pandemic flu, you would either not have enough eggs to make vaccines or the chickens that lay the eggs would be decimated by the strain of flu.

As many probably know, flu vaccine is made from chicken eggs. Basically what you’re doing is using a chicken egg that has a developing chicken embryo in it to grow the influenza virus, and then you harvest the virus from the chicken egg and make the vaccine. As a hedge against avian flu that would either decimate chicken flocks across the country or overwhelm our egg supplies, we created this strategic chicken population that has been segregated in carefully maintained facilities so you 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. It just focused on the flu.

They provide an example of how the US pharmaceutical industry could prepare for the next pandemic. In the book you describe how Hurricane Maria hit Puerto Rico in 2017 and severely disrupted pharmaceutical production. However, there was a facility from the pharmaceutical company Amgen that continued production without interruption. What does it teach us about planning a crisis in advance?

Initially, this system ran at full speed. I mean, they had the generators to back up their generators. They had enough fuel on hand to work without a network for months. And so I asked the obvious question [of CEO Bob Bradway]: Why did you build this exceptionally hardened system?

And his answer was: “We have implicitly guaranteed the federal government that there will never be an interruption in the supply of Neupogen,” a drug manufactured there. Neupogen is used to reconstitute white blood cells, typically after chemotherapy. But if there was ever a radiological attack and people were poisoning their bone marrow with radiation, it would also take a lot of Neupogen to save people from radiation poisoning. And as a strategic safeguard against this emergency, the federal government paid Amgen an explicit sum of money for the construction of these extraordinary facilities.

This is an example of the kind of planning that must be done to hedge against a pandemic. We have to pay for some remaining capacity in the current system. We can’t just build plants and mothball them. We have to keep them warm. We have to keep it going.

The example I’m using is a highly complex diagnostic laboratory that can run 3,000 PCR machines at 80% capacity. That is maximum efficiency. You cannot operate them all the time. You need some downtime, maybe you have 5,000 machines and they are running at 50% utilization. So now you have an overvoltage capacity at your disposal. Someone will have to pay for this remaining capacity because it is expensive. Then the government can step in and pay for a certain amount of remaining capacity as a strategic safeguard against a bad outcome like a pandemic.

They advocate a forecast service modeled on the National Weather Service to leverage strategic data insights so that we are not caught off guard by another pandemic. Do you think we will make it? Will we be better prepared next time?

I hope we will. I mean, the book is my attempt to start a discussion about what we need to do to be better prepared and hardened for these eventualities in the future. I think there will be a more fundamental debate that needs to precede the debate on how we prepare for the next pandemic, and that is the debate on the role of public health. I think in order to be properly prepared for the next pandemic, we need to strengthen the public health authorities. We need to build new capacity at CDC and empower it to act in a future public health crisis of this magnitude.

I think there is currently skepticism about public health. And this is not just some kind of right-left debate, conservative vs. liberal. I think it’s more ubiquitous. So we need to have a fundamental discussion about the role of public health. How do we reform the process by which public health advice is produced and disseminated and reach consensus on the appropriate role of health authorities, hopefully giving them the authority they need to carry out the role they have will? play in a public health crisis.

John Henning Schumann is a doctor and writer based in Tulsa, Oklahoma, where he is StudioTulsa’s. moderated Medical Monday for the public KWGS radio Tulsa.

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