Leadership During Crisis:

A Conversation with Dr. Scott Gottlieb and Dr. Zeke Emanuel

MS. SELLERS: Hello, and welcome everybody to Washington Post Live.

I'm Frances Stead Sellers. I'm a senior writer at the Washington Post. And today, we're going to be talking with two of the nation's leading medical experts about where we stand with the coronavirus pandemic and where we're heading.

In a little while, I'll introduce you to Zeke Emanuel, who's a physician, a health reform advocate, and the Vice Provost at the University of Pennsylvania.

But first, let me welcome former FDA Commissioner Scott Gottlieb, who's also an informal advisor to the White House.

Thank you both for joining us today and thank you to our audience.

Dr. Gottlieb, as an informal advisor to the White House, could you tell us what to make of the conflicting reports about whether the taskforce will be closing or not? I gathered this morning President Trump tweeted it would continue indefinitely.

What are the practical implications?

DR. GOTTLIEB: Well, I'm not that well informed about the internal discussions around the taskforce, so I'll just state that upfront. You know, I'm doing some advisory work for the taskforce over the course of the last several months or last couple of months.

But you know, I saw the President's statement this morning. It sounds like the taskforce is going to continue indefinitely, focusing more on the reopening and some of the issues going forward.

I would expect a lot of the dialogue to shift to therapeutics, as well. I think that you're going to see an increasing emphasis on trying to bring more organization and leadership around the development of therapeutics for COVID-19.

MS. SELLERS: So, it's treatment and vaccines?

DR. GOTTLIEB: Yeah, therapeutics and vaccines, but also the things that the government can affect here, which is trying to bring more coordination around clinical development, and also trying to bring greater resources and government involvement in the scaleup of manufacturing.

I think the more that we can do these things in parallel, the more likely we are to be able to secure sufficient doses of a vaccine in time, if we are able to get one to the market that's safe and effective.

MS. SELLERS: So, that brings me to a question about the federal plan for reopening. Where does that stand at the moment, particularly with the rise in cases in some rural areas around the country?

DR. GOTTLIEB: Look, I think that it's state-by-state, obviously--I think you're going to see more announcements from the different governors going forward, particularly in the Northeast, more granular proposals going forward, and I've been talking to and working with some of those governors.

The reality is that, in the Northeast, you see cases and hospitalizations going down; but elsewhere, around the country, you see hospitalizations, deaths, and cases going up.

Now, some of the reporting on the increase in cases is an artifact of greater testing; we're capturing more cases. But certainly, the hospitalizations are an objective measure, albeit a lagging indicator but an objective measure. And so, it's an indication that, around the country, once you back out the Tri-State Region in the New York area, this is still expanding. There's 20 states where you see cases rising. There's 30 states with 250 or more cases a day that they're reporting. And those trends are continuing. I just put up the latest data on Twitter and, in fact, you see another spike in hospitalizations in cases and deaths around the country.

So, the reality is that we're going to be reopening, and it does appear that we're reopening. I think there's a lot of pressure on governors and there's a lot of economic hardship and public health consequences of the shutdown, but we're going to be reopening against the backdrop of, at the very least, stable infection at a very high level but probably rising infection in many parts of the country.

And so, we have to hope that people continue to take measures to social distance. We have to hope that there's a seasonal effect here that's going to be a backstop against spread going into the summer, or else we can see, you know, sharp rises in the number of cases.

Number of cases is certainly going to go up. They're not going to go down as we reopen. We always expected that, that we would see a spike in cases; the question is how much.

MS. SELLERS: So, tell us a little bit--there's been a report out of Los Alamos recently about the potential for a mutation of this virus, which could make it more contagious. Is that something you are concerned about, looking into the summer and beyond?

DR. GOTTLIEB: Well, I think that that Los Alamos study has to be taken into perspective. What the study was was a computational analysis showing that a certain strain with a particular genetic change in the sequence that codes for the spike protein, which is the part of the virus that it uses to invade human cells. There was a single amino acid-base pair change and that strain became predominant in Europe and then became predominant in the U.S.

And they concluded, based on that analysis, that this strain must be more infective, must be more contagious because that's why it became the dominant strain. But it could be what we call "founder's effect." It could be that this strain just got into Europe and then became epidemic there and Europe heavily seeded the United States and so it became epidemic here. There's nothing to suggest biologically that it's more infectious.

Something similar happened with Ebola where there were two strains of Ebola. There was a single base pair change in the Region that infected human cells. At that time, we had some cell culture studies, as well, and there was the conclusion drawn that it was more a infectious strain of Ebola and there was a lot of press around that at the time. It turned out, when we put those two strains into animal studies, they turned out to be equivalent in terms of their infective ability.

And so, it's really early and, I think, premature to conclude from the Los Alamos study anything at all, and certainly conclude that this is a more infectious, more transmissible strain.

MS. SELLERS: You sounded the alarm, though, about the danger of this virus back in January. Why did the White House not listen to you then?

DR. GOTTLIEB: Sorry, I missed the...

MS. SELLERS: Sorry. You sounded the alarm in early January about the danger of this virus. Why did you not get a response from the White House at that point? Why did they not...

DR. GOTTLIEB: Well, you know, I was having discussions with officials. You know, I remember the very first phone call I made to a senior White House official about this, it was the day that the SitRep report came out showing that the number of cases in Wuhan had quadrupled from 50 reported cases to almost 200; it was about 180. I remember the exact day.

And there were White House officials that I was talking to all the way through about my concerns here, and I think that they shared my concerns. And so, there were people in the government in the government, I think, who shared concerns around this.

You know, we can sort of armchair quarterback what could have been done earlier around this, but there were people who were concerned that this had pandemic potential and some of that reporting has come out now, including by your newspaper.

MS. SELLERS: So, you have worried about a potential fall outbreak. How long do you think this virus is going to be with us? And what can we do now to try to prevent the kind of crippling economic lockdown we've got at the moment?

DR. GOTTLIEB: Well, I think that the risk is--so, we're going to start to reopen the economy, but the reality is that the economy is not going to reopen in the way that we would want, so long as this virus is circulating. I think consumers are still going to be very nervous about doing the kinds of things and reengaging in the kind of activity that it did before. And so, there's going to be a persistent drag on the economy so long as this is circulating at levels sufficient to create enough concern that it's spreading and that you can catch it.

And so, I don't know what the economy actually looks like in a backdrop where we haven't really snuffed out the spread of this virus to a lower level than what it currently is at.

The worry that I have is we reopen against this backdrop of persistent spread of about 30,000 cases a day, which is probably more like 300,000 cases a day, because we're probably diagnosing 1-in-10 to 1-in-20 infections, and the seroprevalence studies seem to show that.

We sort of simmer through the summer at those levels. Maybe it goes up, you saw the CDC preliminary analysis that they put up which showed a spike in infections. But assuming an optimistic scenario where it doesn't go up, maybe it remains, at worst, stagnant, through the summer and there is a seasonal effect here. Maybe it even goes down in July and August in the depth of the summer, as H1N1 did in 2009. Nonetheless, there will still be enough persistent spread that it could come back in the fall in a more robust way and we face the risk of renewed outbreaks in the fall, especially heading into flu season. That's my concern, that this collides with flu season.

MS. SELLERS: And is there anything that--you know, you have said that mitigation hasn't worked as well as you had hoped. What did you mean by that and how should we be doing things differently?

DR. GOTTLIEB: Well, look, it depends on how you view mitigation. The primary objective of mitigation was to, as we said, push down the epidemic curve, suppress the infection to the point where the health care system wouldn't become saturated, wouldn't become overwhelmed.

We knew when you put in place those mitigation steps, what you do is you flatten the curve. You basically push it down. So, the peak is lower, but you extend it out. So, you end up with a longer epidemic as a result of mitigation and we knew that.

But I think what has surprised people, and some of us--including me, quite frankly--is that I felt at this point after a month of those mitigation steps and social distancing, you'd start to see sustained declines in new cases.

We really haven't seen that nationally. We've seen it in the Northeast, we've certainly seen it in California, parts of California, and Pacific Northwest, Los Angeles, we have not seen that. But around most of country, you have not seen sustained declines in new cases outside of certain states like Ohio, Idaho. Louisiana has demonstrated that. Hawaii shows a very steep epidemic curve, sharp up, sharp down. So, there are states that we see a resolution, but around most of the country, you don't see that. And in fact, what you're seeing is a rising number of cases. So, that has surprised me. I thought that at this point we'd see more of a sustained decline and that we'd be reopening in May, because there was always an expectation we'd be sort of compelled to reopen in May given the economic hardship, but we'd be reopening in May against a backdrop of much less infection.

MS. SELLERS: So, you've talked about the three "Ts" with this regard: testing, contact tracing, and treatment. Why is the U.S. so far behind on testing? And can we reopen without efficient testing and effective, accurate testing?

DR. GOTTLIEB: Yeah, well, we've had a dramatic scaleup in testing when you look at what's happened over the last month or six weeks. We're testing about 1.5 million a day. I suspect by the end of May we'll be testing two million a day, maybe more. And I think by the fall we're going to have such robust capacity that the issue is not going to be the capacity to do testing but it's going to be a question around the sites, and whether or not primary care sites are willing to test for coronavirus.

But the reality is we got a late start. Things that happened in late February and March should have happened in January and had we, in January, you know started to engage the commercial labs and the academic labs and spin them up and get them into the game, had we started to engage companies that had the ability to put these kinds of tests on point-of-care platforms and develop antigen-based tests. We would have had that technology available by the end of February, early March, certainly--probably earlier than that. But we got a late start, and so the reality is, because we got a lot start, we're going to get a late finish. And the capacity that we would have wanted in April and May, we're going to have in June and July.

MS. SELLERS: So, that brings me to a reader question I'm hearing from people listening in. This is a question from Bridget Dreary [phonetic] that I'd like to read in Virginia.

She says, "In times of crisis, how do you balance relying on proven frameworks and methods while still encouraging creative and innovative solutions?"

DR. GOTTLIEB: Well, I think we have been, you know, improvising as we go. We've never dealt with a pandemic before. We are playing off of a playbook in terms of the mitigation that we implemented, but we are improvising as we go to try to--

MS. SELLERS: Because we've had so many warnings about pandemics: We've had SARS, we've had MERS, we have flu. We have respiratory illness every single year and, every five years, we have bad flu. And public health officials have warned about pandemics for decades. So...

DR. GOTTLIEB: Yeah, I think a lot of the pandemic planning was geared towards influenza. I'm not sure that we ever anticipated a pandemic with a coronavirus, even though we should have, given the outbreaks of MERS and SARS, to your point.

But there was always a thought that if there was a pandemic strain of influenza, we'd be able to get to a vaccine more quickly. And so, the mitigation was intended to be a bridge to a vaccine. Mitigation isn't a bridge to a resolution. And so, that's the challenge we're facing right now. We've implemented the mitigation. We've spared the health care system from being overwhelmed. We've managed to push down the peak of the epidemic curve.

But a bridge to what? It's a bridge to persistent spread. And ultimately, we're going to need a technological solution in order to fully resolve this, and that technological solution, unfortunately, is going to take longer than it would have if this was, perhaps, an influenza where we have more experience developing therapeutics and vaccines.

MS. SELLERS: So, when do you think we could have a vaccine?

DR. GOTTLIEB: Well, I think that we'll hopefully have a vaccine, assuming that the vaccines that are currently in development and in clinical trials--and there was a clinical trial announced yesterday by Pfizer Company. I'm on the board of a very robust phase one/phase two study that's going to be conducted here in the U.S. They're one of a number of companies that have candidates.

Assuming that those vaccines show success in early-stage phase one studies show success in safety studies and show that they're--they generate immunogenicity. They generate an antibody response that's predictive that they could provide immunity, I think that we're going to have enough vaccine to run largescale studies in the fall. And I suspect those studies are going to be run in the context of outbreaks. So, if we do have outbreaks in a large American city, what we're likely to do is use hundreds of thousands of doses of those vaccines, experimentally, still, but in large protocols where we would both try to ringfence the outbreak, as well as turn over the card on whether the vaccines are safe and effective for general use.

And so, you do what's call a "step wedge cluster" randomization, which is basically you randomize sequential intervals of the population to the vaccine and look at whether the time in which you got vaccinated affected the propensity of different populations of people to get the virus. So, you randomize one group to early intervention, one group to mid intervention, and one to late intervention, and then you compare the three groups.

MS. SELLERS: It feels as if we only just got started, but we're going to need to wrap up and thank you very much for joining us today.

DR. GOTTLIEB: Thank you [audio distortion]--

MS. SELLERS: So, that's all we do have time for, but please, everyone else, stay tuned. I will be back after a short video to talk with Dr. Zeke Emanuel who, as I said, is a physician, a health reform advocate, and the Vice Provost at the University of Pennsylvania.

Thank you, Dr. Gottlieb.

DR. GOTTLIEB: Thank you.

[Pause]

[Video plays]

MS. SELLERS: It gives me great pleasure now to welcome Dr. Zeke Emanuel. He is a physician. He's health reform advocate and he is the Vice Provost at the University of Pennsylvania, and he joins us here today from his living room, as we all are.

Dr. Emanuel, you said that the U.S. won't return to normal for 12 to 18 months. What do those intervening months look like to you?

DR. EMANUEL: Well, unfortunately, they're quite hard months. We're going to have to maintain a lot of the physical distancing, staying six feet apart, getting into our pods, wearing facemasks in public, continuing our handwashing, and we're going to slowly try to expand the number of businesses that are open and where people can engage while keeping other parts of the economy closed, parts where there's large groups of people that cannot social distance, parts that include nursing homes and long-term care facilities where particularly vulnerable parts of the population are present.

MS. SELLERS: [Audio distortion]--

DR. EMANUEL: So, I think we do that slow opening, as it were, in phases over time. And we have to be prepared to reimpose more restrictive measures when we see some flare-ups, outbreaks, resurgences, whatever you want to call them.

MS. SELLERS: You heard Dr. Gottlieb talking about his ideas for when a vaccine may be ready. When do you think we might have one and how would you think it would be deployed in a way that can actually affect a population?

DR. EMANUEL: Well, Scott, I thought, was optimistic. I always like to note that almost every scholarly item you read says, "if everything goes perfectly." And those people who've been engaged in vaccine production in the past knows that it's rare that everything goes perfectly. I would also point out that it's basic that we have you might say four different kinds of candidates that we're--vaccines that we're trying.

We're trying some of these new MRNA DNA vaccines. We're trying a viral vector, so we take a cold virus like adenovirus and we put the RNA of the coronavirus in to generate an immune response. We then have inactivated or live-attenuated virus particles.

And then, we have the sort of artificial viruses that have the spike protein on them. Some of those are tried and true, like the inactivated virus vaccines, but they take many years to develop. They have--you know, they tend to have a lot of serious side effects.

Some of those we've never developed a viral vaccine from, MRNA or DNA. And so, it's really--they're easy to get into the clinic, but they're much more of a shot in the dark.

And then, the final point is, even if we prove--you know, I thought Dr. Gottlieb was a little optimistic that, by the end of the year we'll have evidence, we'll be going into a big phase three in the fall. I think that might be premature. But say we are in, say, October, November, December, sometime like that, starting big phase threes, you still have to find out how many people get infected, and that takes time.

And then, you're going to have the whole production. Yes, we're going to ramp up production. Some of those are easier to produce than others. Not all of them can be wildly produced to a billion doses. And then, the distribution is also going to be a problem.

All of it sounds--you know, we could have it in 12 months--yes, I think we could have it in 12 months, but I don't think that means all of us in the country are going to have it in 12 months. So, I'm looking at the fall 2021, maybe January 2022. I think that's when we're very likely to have it and it's going to be widely distributed--or very likely. That's--if everything goes well, that's when we could have it, and that's with--

MS. SELLERS: The long haul.

DR. EMANUEL: It's a long haul, and I think I just get upset when our leadership doesn't prep people in the way that Winston Churchill prepped people for the long haul of the battle with Germany.

MS. SELLERS: Right.

DR. EMANUEL: And I think being honest with people--you know, when I'm on an airplane, I prefer that the pilot be honest with me about what the delays are. And I think it is somewhat the same here. I can plan better and it also means that we'll have public policies that can plan better for the time period instead of a rapid--you know, we're going to give everyone $1,200. That's really important, but that's not going to carry you for 18 months. So, we need a planned subsidy situation that will carry people for 18 months. So, we need a planned subsidy situation that will carry people for 18 months.

MS. SELLERS: So, let me ask you a little question about the clinical trials going on. We heard some good news out of NIH with remdesivir; it's not a curative drug.

But we have a reader question from Jasmine Smith in Virginia who says: "How long before we learn the results of other clinical trials that are going on?" Can you give us a little bit of a perspective there on what's happening in the science and what we can expect to see in the next...

DR. EMANUEL: It's a really good question. So, basically, when I think of the therapeutics, there are sort of two kinds of therapeutics that you have. One is that we take drugs off the shelf that we think might work and we try them in COVID-19. I'm skeptical that we're going to have much big impact on that. I think remdesivir, you know, it's a marginal impact that didn't improve survival; what it did is got people out of the hospital four days faster. That's hardly a home run. It qualifies for a little improvement and encouragement and proof of principle that we can impact but hardly a very big change.

Most of the off-the-shelf stuff doesn't typically work in new scenarios. There are some notable cases, thalidomide--I'm an oncologist. Thalidomide was developed in the '60s for pregnancy but it really works well for a type of blood cancer, multiple myeloma. We know Viagra was a--

MS. SELLERS: --problems with pregnant women, right, thalidomide?

DR. EMANUEL: Yeah, it was originally developed for pregnant women, for nausea and vomiting. It was--caused serious birth defects, but now it works for cancer.

MS. SELLERS: Okay.

DR. EMANUEL: We have Viagra that was originally developed for blood pressure and now works for erectile dysfunction. There are a few other cases. But in general, that doesn't work too well.

And by the way, besides remdesivir, we've tried a number of other drugs that have failed, including hydroxychloroquine.

What we really need are drugs designed for COVID-19 disease, and those are going to take longer, because you're going to have to do safety studies on them and then you're going to have to assess them in the clinic, you know, trying them out with monkeys and seeing that they really do prevent monkeys--do prevent monkeys from getting sick from COVID is going to be--it's going to give us early indications whether these drugs can be effective.

But then, we still have to do safety trials and the trials with humans to make sure it does help people. And I think that's going to take probably--maybe not quite as long as a vaccine. But the idea that, by January, we're definitely going to have a therapeutic is somewhat doubtful.

The other thing I would mention, Frances, is you know, for a lot of these viruses, like HIV or hepatitis C, we need more than one drug. You know, I'm an oncologist. Typically, in cancer, you don't get away with one drug, you need a drug regiment hat has drugs in it.

It's very likely that, for COVID-19, the same will be true. So, it won't be just one therapeutic that we'll get. We'll probably need a couple of therapeutics used in conjunction.

MS. SELLERS: So, let me take you now to a question about our health care system.

We spent--there's no shortage of money spent on health care in this country; and yet, we've ended up with this disaster. Where do we need to be reinvesting resources? Where do we need to rebalance the system to try to make sure when we see another pandemic, as we almost assuredly will in coming years we don't lend--end up with this kind of crippling lockdown?

DR. EMANUEL: Really good point. So, let's differentiate two parts. One is the health system, that is, you go to the doctor, you go to the hospital. You get diagnostic tests. That has been overwhelmed because we had this big surge in--you know, at the emergency room with the very infectious disease. But what we really needed was a public health response early on and I think what Dr. Gottlieb talked about was the failure to activate a public health response in January or February at the latest, and I think that's a different item. That's not so much your individual doctor and the hospital; that is putting in place some of these public health measures that we've now gotten used to, the physical distancing measures, the--abandoning the large groups--[audio distortion]--

MS. SELLERS: --chronically underfunded in this country, right? It's always been the sort of--the place you could take money from in 2008. I know a lot of the public health departments lost huge amounts of money.

Do we need to revamp entirely and centralize public health across the country, or what's your prognosis there?

DR. EMANUEL: Well, a lot of the local and state public health agencies were funded through CDC. And as--you're correct, it is chronically underfunded. It's in the low billions of dollars in terms of total funding to the CDC and it should be much, much more and we should redo their program.

I will say, to be very, very clear about it, you know, beginning probably in 2005 with Secretary Leavitt, to his credit, he came in, recognized that pandemic was a real threat, commissioned some pandemic preparedness work, and that's a poor stepchild all along.

When we were in the Obama administration, we did focus on pandemic preparedness, in part because we had H1N1 right at the start of the administration and it alerted us to the problem. We then had MERS and we did learn that we needed to prepare things--and Ebola happened, as well. But that message did not get carried over into the current administration and, as has been noted early in this process, they were proposing 19 percent cuts to the CDC just when we were hitting a pandemic.

That seems like not rational policymaking, with an agency whose budget was already pretty tiny. And I might say that Secretary Leavitt did take the initiative in 2005 to get the pandemic preparedness at the top of the agenda because SARS had just happened and it, again, alerted him to the threat of a serious novel virus pandemic. And so--

MS. SELLERS: I have another question that I'm dying to ask you about, and that is--

DR. EMANUEL: Okay.

MS. SELLERS: --about the politicization of public health. Is there any way out of that? Is this a new phenomenon? And is it peculiar to an election year where there's--you know, points are being scored?

What's the future of public health, given the politicization right now?

DR. EMANUEL: Let's hope it's not politicized because it really isn't a political matter. It is a matter of science, as we can see from the influence of the public health measures that have really brought the death rate down in New York and brought the hospital demand down in New York.

They work and we need more of them, and we need more campaigns. Part of the problem is that public health has gotten politicized because it deals with gun violence, it deals with smoking and vaping, and these things have become, unfortunately, tied up with the culture wars rather than just focusing on the science and the dangers that they pose to science and the dangers that they pose to people's health, longevity, morbidity.

I am hoping that we can, you know, just look at the data and design policies that effectively implement the data. You know, that's true in some other countries and they have done better on some of these very important measures.

It also happens to overlap with taxation. For example, one of the best ways we know of decreasing smoking is just raising taxes.

MS. SELLERS: You are advising Vice President Biden, I believe. What would be some of the top things you would recommend if he were to become President?

DR. EMANUEL: Well, we're going to have to focus on the production and distribution of a vaccine.

As I mentioned at the top of our interview, even if we get a vaccine quickly, getting enough of it for the whole country, for the whole world, and getting enough of it out there and in people's arms is going to be a huge challenge and a huge logistics challenge. And I think that is--day one, that's probably--you know, whether we have the vaccine ready at that moment, coordinating that effort to make sure it happens is going to be a major challenge. And I think, at least on COVID, that's going to be important.

I think reexamining the balance between health care spending and public health spending is another major area that we really need to look at. And figuring out how to restructure our health care system so we don't have this problem again is also going to be the third topic that would have to be looked at by a new health care administration.

MS. SELLERS: So, an entire restructuring of the way health is delivered across the country?

DR. EMANUEL: I think a restructuring of how we pay for it, making sure we have universal coverage is going to be vitally important. If anything's been shown by this, you can't leave a large portion of the population out.

And then, we do need to think about how to shift and make sure doctors don't become bankrupt and do continue with their telemedicine and restructuring hospitals so they're not so reliant on elective surgery for their money and providing better health care is more of a focus.

MS. SELLERS: Well, thank you very much. That's all that we have time for this afternoon. I feel as if we could have continued both of these conversations for much longer.

Thank you, Scott Gottlieb.

DR. EMANUEL: Thank you.

MS. SELLERS: Thank you, [audio distortion] Emanuel. It was a pleasure to have you.

And everybody else, please stay tuned. My colleague, Jonathan Capehart will be interviewing Nasdaq CEO, Adena Friedman, at 1:15 p.m. So, back on Washington Post Live tomorrow. Thank you.

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