Former FDA Head Scott Gottlieb's Lessons For Controlling The Next Pandemic
Dr. Scott Gottlieb was FDA commissioner under President Trump, from 2017 to 2019.
He’s been highly critical of how the U.S. responded to the COVID-19 pandemic:
“We didn’t have the right infrastructure, we didn’t have the right agencies. The agencies weren’t properly empowered, properly resourced.”
Now, he says, we need a national conversation.
“We need to bring together a bipartisan commission,” he says. “We need to bring together thought leaders to try to develop a plan for the future.”
Today, On Point: Public health, national security and a conversation with Scott Gottlieb.
Scott Gottlieb, resident fellow at the American Enterprise Institute. He served as commissioner of the Food and Drug Administration from 2017 to 2019. Author of the forthcoming book “Uncontrolled Spread.” (@ScottGottliebMD)
On blunders in America’s COVID response
Scott Gottlieb: “There were mistakes made at every level. And I deliberately in the book tried to focus on the more systemic shortcomings in the structure of the U.S. response. And not just focus exclusively on the political shortcomings. But there were clearly political mistakes, mistakes in leadership all along the way. And so setting those aside just for the moment, and focusing on the structural features of government where where we went wrong, going back and looking at those op-eds in January that I had written. And this is, again, a big focus of the book.
“What I was advocating at the time was that we should start a very aggressive effort to try to develop and deploy mass screening tests, diagnostic tests to employ what we call sentinel surveillance. Where basically what you would do is people who are presenting with flu-like symptoms, but testing negative for flu. So they have some other respiratory virus. We should have been testing those people at a massive scale to try to see if coronavirus was starting to circulate in the United States.
“We didn’t early enough work with the manufacturers and labs capable of scaling that kind of testing to have that in place in the timeframe that we needed. In order to do that, in order to have that in place in a timeframe that was required, we would have had to begin that effort at some point in January. As it were, we really didn’t start that effort till the end of February or early March. So we were way late to this, and we were way late to recognize the scope of the threat.
“Someone in January needed to say, This may become a global pandemic. The only way we’re going to be able to protect the United States and be able to identify the spread, get people tested, isolated, quarantined — if they’re sick — is with a massive diagnostic testing campaign. We need to start getting the commercial manufacturers capable of scaling that testing in place right now. That just didn’t happen. That conversation never happened.
“And in part, it was because we were playing off of a very old blueprint, the old blueprint for pandemic preparedness had the CDC would be the first organization to get samples of a novel virus. They would design their own tests. They would deploy that test to the 100 public health labs in this country. Each of those labs is capable of doing about 100 tests a day. That’s 10,000 tests a day, which is way insufficient relative to the crisis we faced. If that still isn’t adequate testing, then CDC would work with the academic labs … to develop what we call laboratory developed tests.
“And if that still isn’t enough testing, then they would work with the commercial labs that are able to mass manufacture diagnostics and distribute them to commercial labs across the country. That’s a highly iterative process. And actually the CDC’s blueprint, which I reviewed for the book, actually had this unfolding over the course of six months. We didn’t have six days, let alone six weeks, let alone six months to get this in place.
“And so we were playing off of a blueprint where the expectation was that the pandemic strain would sort of emerge and evolve on a much slower timeframe frame. Whereas this coronavirus raced around the world, and raced around the country.”
It took a long time before Americans could access tests. What led to that failure in particular?
Scott Gottlieb: “It was all those things. It was a failure of leadership. Someone saying early on in January, we need to do this. We need to start prepping this testing, in this infrastructure, in the U.S. as a contingency. In case this ends up being a national epidemic. I don’t think that there was a clear vision of how severe this could be, and the kinds of tools that we would need.
“And then there were just practical problems with rolling out the tests. CDC insisted on making the test itself. So they didn’t make viral samples available to academic and commercial labs that could have developed their own tests. They actually didn’t do that until the end of February. So they designed their own tests using their access to the virus samples. And then they developed intellectual property around their test.
“And so other commercial manufacturers of labs wanted to use the CDC design in order to make their own tests. Because those commercial labs couldn’t get access to virus samples in order to design their own tests. CDC said, Well, you’re going to have to license our intellectual property. This is a setting of a public health crisis, or an evolving public health crisis. And CDC is putting long legal documents in front of commercial manufacturers, asking them to sign agreements to license the agency’s intellectual property.
“And so companies, I talked to them at the time, when this was going on, I said, Look, we can’t negotiate with CDC. It’s going to take us weeks, a month to do this. We’re going to wait and see what happens. So CDC went forward with their tests. Other people sat on the sidelines, and CDC ended up contaminating their test. So what they were doing was they were — what I believe they were doing, and I reported this in the book — they were testing running samples.
“So if you were a doctor sending in a patient sample to be tested, the only place that was testing patient samples in January and February was the CDC lab. So you had to send your patient sample to the CDC lab. So they were running those samples. And in the very same room, they were designing their diagnostic tests. And at some point, the virus went from the samples that they were running, the patient samples, into their manufacturing process.”
Do you think things would have been different if there had been another president in place?
Scott Gottlieb: “I think things could have been different. I think some of the same challenges would have faced us. And I think you’re seeing that even now with the Biden administration. Where the Biden administration is struggling, in my view, at least, because they’re not getting timely information. They’re not getting actionable information from the agencies that they’re depending on, as well.
“I think they’re suffering some of the same challenges working with CDC. Where CDC isn’t able to respond in a timeframe on some of the critical questions that policymakers need to work within. So would we have had a different response if political leadership was more seriously focused on the early challenges we face with this virus, and got agencies more engaged, more aggressively, back in January and February in the opening days of this crisis? Absolutely. But I think we still would have suffered some of the same shortcomings.”
What needs to change about our institutions? Do we need a new agency to oversee pandemic response?
Scott Gottlieb: “I’m clearly critical of the CDC’s role in this response. But I think, you know, in fairness to the CDC, the agency was never invested with the right resources, authorities, capacity to really handle a crisis of this magnitude. There was a misguided vision among policymakers that the CDC had this, that they’d be able to quarterback the entire national response to this crisis. And they never had this.
“They are a very retrospective organization. They’re accustomed to doing very exquisite analyzes based on bespoke data feeds. They’re slow. They’d rather take four or five months, and do a definitive analysis, rather than surface real time information to inform policy decisions that have to get made, in the moment, to respond to a current crisis.
“But I don’t think the answer is to build a new agency or dismantle CDC. I think we need to invest in CDC with a proper sort of authority and entity capable of handling a crisis, a public health crisis. That’s a national crisis. And it’s much more of a national security mindset that needs to be imbued in the CDC. And the capabilities to scale an operational response. Something like a FEMA-like capability, where you have the ability to deal with a public health contingency of this magnitude.
“I think before we have that discussion, though … there is now coming out of this a lot of skepticism of public health agencies and authorities issuing guidance that becomes binding in the setting of a crisis like this. And it’s not just a right-left debate, Republican or Democrat. I think it’s far more pervasive than that, where people now are skeptical because they felt that the advice they got constantly changed. Wasn’t well grounded, wasn’t pitched in a way that it could be incorporated into their lives in sort of a practical way.
“And we’re going to have to have that more fundamental discussion and debate. Because in order to have adequate preparations going forward, we’re going to have to imbue public health authorities with more authority, more agency, more resources. But there’s going to be people who are reluctant to do that. And so that’s a fundamental debate that we need to have in this nation.”
What do you see as our future with this virus? Where do we go from here?
Scott Gottlieb: ”This is going to be a virus that continues to be with us. It will be an omnipresent risk. It’s not going to represent the same level of risk that it poses right now as we’re in this pandemic, and spreading in an uncontrolled fashion. And the migration from the pandemic phase, to the endemic phase when this just becomes a pervasive virus, and spreads like other viruses do each season, and settles into more of a seasonal pattern, there’s not a bright line.
“It’s like a recession. We’re going to know when it went from a pandemic to an endemic two quarters after it happened. Or, you know, a year after it happened. But we’re in the throes, I think, of that transition right now. Delta is probably the last major wave of infection on the back end of this. This will start to settle into more of a seasonal pattern. But if COVID continues to spread each winter, which I believe it will. Alongside influenza, the combined impact on life, on productivity is going to be too great for us to be complacent about the risk of respiratory pathogens in the wintertime.
“We’re going to have to reorder society in some fashion to reduce the risk from these twin pathogens. That means making buildings, improving air filtration and handling and putting hospital grade air filtration in buildings, the de-densifying offices where we can, improving work life to keep people safer from respiratory pathogens.”
From The Reading List
The Atlantic: “A Second Major Seasonal Virus Won’t Leave Us Any Choice” — “This pandemic will eventually be over, and the Delta surge—in which most of those not yet vaccinated against the coronavirus could become infected—may well be America’s last destructive wave. But just because we’re eager to move past the virus doesn’t mean it’s finished with us.”
This article was originally published on WBUR.org.
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