April 10, 2020

Scott Gottlieb

President Trump’s former FDA Commissioner Dr. Scott Gottlieb discusses what is next for the coronavirus. Gottlieb says he is concerned about a second wave of COVID-19 that may hit in September. Gottlieb says parts of life may be altered until there is a vaccine, which could be still two years away. Gottlieb also discusses the prospects for antiviral and antibody medicine to treat the virus.

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He’s the former Trump administration official who sounded the alarm back in January, this week on ‘Firing Line.’
This is probably far more contagious than what we first assumed.

Former FDA commissioner Dr. Scott Gottlieb said the U.S.
needed to act fast and decisively to defeat the coronavirus in America.

I think we need to change our posture here in the United States.

At that time, the President was saying this.

We think it’s going to have a very good ending for us, so that I can assure you.

With thousands of American lives already lost, hundreds of thousands infected, and the world turned upside down…
We face a lot of risk and we need to get the tools in place to mitigate that risk.

…Gottlieb continues to focus on the future.
He’s written a roadmap for recovery.

I just — I just received it a little while ago.
He sent it over.

What does Dr. Scott Gottlieb say now?

‘Firing Line with Margaret Hoover’ is made possible by… Additional funding is provided by… Corporate funding provided by…
Welcome to ‘Firing Line,’ Dr. Scott Gottlieb.

Thanks for having me.

You are the former FDA commissioner in the Trump administration, a resident fellow at the American Enterprise Institute, and on the board of Pfizer, a drug company, and Illumina, a diagnostics company, both of which are involved in aspects of the response to COVID-19.
I think it’s also important for our viewers to know that you are a trained medical doctor who worked in New York City.
And you have managed to receive praise from both Republicans and Democrats alike because of your time at the FDA and also because of your early response and voice to the COVID-19 crisis.
And we’re delighted to have you here to delve into your roadmap and your view of how we should tackle this crisis next.

Thanks.

You tweeted back on January 6th about a mystery disease less than a week after China had publicly acknowledged its first novel corona case.
How did this get on your radar from the very beginning?

Probably started tracking it late December, early January, when these cases first started to emerge.
And what was concerning about it was it — it sounded very SARS-like, but it seemed more transmissible.
There were some early reports from some physicians in China that this was highly contagious.
And we always feared that sort of perfect pathogen, one that would have a lethality, that it could cause a lot of death and disease, but be contagious enough that it could spread around the world.

You wrote an opinion editorial at The Wall Street Journal on January 28th.
You said… Now, at the time, your focus in that piece was not on mitigation, not on social distancing, but on increased testing and on medical supply availability.
You know, you can’t help but wonder when you read that piece now that if your advice had been heeded, we may not be in the situation that we are now of mitigation and the throes of the crisis of this pandemic.
What’s your response to that?

Well, my concern early on was that we don’t have enough surveillance in the United States, didn’t have enough testing in place to be able to detect this if this came to the U.S.
I knew from working at FDA that it took time to get that kind of testing capacity in place.
So I think the real inflection point for a lot of us was on January 18th, when a report came out that the cases in China had quadrupled, had gone from about 50 cases that they were reporting in Wuhan to about 200.
And that was a real wake-up call.
I think that was a day that a lot of people got very concerned about this.

It was the day after your piece came out that the White House Coronavirus Task Force was formed.
And, you know, it was reported that you were in the running to lead it before Vice President Pence was announced as the leader of the coronavirus task force.
And you’ve been called by media reports, Politico in particular, as the shadow coronavirus czar, which I know is a title you eschew and say isn’t fair, but you are currently serving as an informal adviser to the White House Coronavirus Task Force, are you not?

I talk to them quite regularly.
I mean, I talk to the White House folks, you know, almost every day, if not a couple of — you know, every other day.
And I’m also talking to a number of governors, congressional staff.
And so I’m trying to provide perspective to a lot of different people who are involved in this.

There are now eight states that still haven’t told residents to stay home.
Now, you served in two Republican administrations.
You’re advising Republican governors right now.
Do you have any advice for those eight states, all of whom, coincidentally, have Republican governors, about how to handle this virus as it approaches higher levels in their states?

I don’t think every state has to have the same response.
I do think most states should be implementing pretty strict measures at this point.

Well, that’s my question for you.
I mean, as a public-health official, is it advisable for any state to not have stay-at-home orders right now?
Is it okay for Iowa not to have a stay-at-home order?
Do you think that’s advisable from a public-health perspective?

I think a state like Iowa should, given the fact that they have dense urban environments.
But I think it’s advisable that most states be contemplating these things and implementing them at this point, because the problem is we don’t have enough testing and surveillance in place to really identify where the risk is.
So a lot of states may think they have low levels of spread and low levels of risk but be underestimating it.

Yeah.
But let me ask you about a headline that was at National Review this week, and it was about Sweden and how Sweden is handling this crisis.
The authors of the piece wrote, ‘Sweden has kept schools, bars, restaurants, parks, shops open’ and only isolated the most vulnerable citizens, the elderly, those with underlying conditions.
The headline of the piece is, ‘Has Sweden found the right solution to coronavirus?’
Is that approach, while very different from the United States’s approach, one that is viable from a public-health perspective?

And the United Kingdom contemplate this kind of an approach, too.
The theory is that the people who are most affected by this virus are older, older individuals.
And if you can just isolate individuals with preexisting health conditions who are older and more likely to suffer bad outcomes from this virus, you can allow it spread in the general population and develop what we call herd immunity.
Basically, enough people get it that it stops spreading.
I think there’s a lot of problems with that theory.
First of all, it isn’t just older Americans that are having bad outcomes with this virus.
There’s a lot of younger Americans, 40, 50, who are succumbing to the virus but also having prolonged hospitalizations with prolonged stays in the ICU and intubation in order to survive this virus.
The other issue is that we don’t know that we can achieve herd immunity here.
Right now, when you talk to people who’ve modeled spread of this virus in the United States, they predict anywhere between 1% to 5% of Americans have probably been exposed to this at this point and developed some level of immunity to it.
That’s a very small percentage.
And look at all the death and disease we have with just 1% or 2% the population having been exposed to this.
If we allowed this to run through the population and infect 40% or 50% of the population, which is what it might take to develop herd immunity, probably a little more than that, there would be a lot of morbidity and a lot of death associated with this virus.

All right.
So, to that point, I want to read to the audience something you wrote this week in The Wall Street Journal editorial opinion pages.
You said… What do you say to people who are really hoping and aspiring that, you know, ‘We can start getting back to normal by the end of April’?
Well, look, I think we’re going to make a transition in May where we’re going to start to reopen the country and people are going to start to resume aspects of their normal lives.
I think that transition will accelerate in June.
And by July and August, it may be relatively quiescent in this country.
We may see cases really drop off as we get into the depth of the summer.
I’m very worried about September.
This is a virus that’s probably going to infect the southern hemisphere.
There’s probably a seasonality to this.
We’re going to see epidemics in the southern hemisphere.
But it’s going to want to come back in September.
It’s going to want to become epidemic.
This is a virus, the characteristics of which suggest that it wants to infect 40% or 50% of the population.
And the question is, are we going to have the tools in place in September to prevent that from happening?
And I’m concerned that we don’t yet have those tools in place and don’t really have a very clear path to how we’re going to obtain them.
And while we may never — we may not have an outbreak like we have now, an epidemic like we have now, I do worry that we’re going to have sizable outbreaks, and this is going to continue to be a drag on normal activities.

You’ve recently written a publication through the American Enterprise Institute called ‘A Roadmap to Reopen.’ And it deals with this series of phases that you say need to happen in order to reopen.
I want to break those down, but first, I want to listen to what President Trump said about your roadmap.
Let’s take a look.

Scott Gottlieb, your former FDA commissioner, wrote a roadmap for recovery after the coronavirus.

Yeah, very interesting.
I saw it.
He’s somebody — he was with me for a long time.
He did a great job at FDA.
So, we’re going to take a look.
I just — I just received it a little while ago.
He sent it over.

So your roadmap calls for the continuing of slowing the spread, developing the ability to treat the virus, either through vaccines or therapeutics, and, also, you recommend technology that will allow for widespread surveillance.
And I want to get to all of those, but first, you know, according to your roadmap, social distancing is going to need to stay in place for some time until two things are achieved, you write.
First, that cases will need to be declining for 14 consecutive days in a certain jurisdiction, and that jurisdiction will need to have the ability to implement widespread testing.

Right.
You need to have the capacity to test in the community.

So, you know, several companies are working on these rapid tests.
And I want you to listen to what New York Governor Andrew Cuomo had to say about it.

Also, rapid testing to determine whether or not you have the virus now exists.
They have ’15-minute tests’ that are commercially available.
But again, they have to be brought to scale.
No private company has the capacity to bring those to scale.

So, Dr. Gottlieb, how long do you believe it will take for us to get rapid testing widely available?

Well, it’s already deployed.
So one of the systems is by a company called Abbott that’s currently deployed in 18,000 doctors’ offices across the country.
And they developed a kit that goes on their existing platform.
It’s the platform that doctors use to test for flu or strep throat.
So it’s deployed.
It needs to be expanded.

So how long before, you know, you and I can walk out just ordinary people, right?
You’re not ordinary, but ordinary people can walk out and really get a rapid test.
I mean, is that a matter of weeks or months?

Yeah, unfortunately, probably months.
It’s not going to be in place in time.
And that’s what I’m concerned about, that if you don’t have this in place, certainly when you transition away from these population-based mitigation tactics, basically asking people to stay at home and not work, you want to have that testing widely deployed, and we’re not going to have that in place in a month.
We could have it in place by September, by August and September, and we have to make that a goal right now.
But we’re going to be flying without all the tools that we want once we start lifting these measures come May.

Is that wise?

It’s a concern.
I mean, that’s what I’m — If you ask me what I’m most concerned about with respect to transitioning the country as cases fall off, it’s the fact that the healthcare system is still gonna be overburdened because there is a delay in hospitalizations and deaths.
And that’s one concern.
But the other big concern is the fact that we’re not going to have the diagnostic capacity in place that we need.
We started late, and so we’re going to finish this job later than we should.

It is clear.
I think we all understand now that we had a series of fumbles at the beginning of this testing.
The Washington Post has written about these testing failures and their quote is… In your estimation, does that fairly characterize the government’s failure?

Well, I don’t know all the details of what went on.
I’ve read the same articles.
The CDC tests clearly had challenges associated with it and was delayed in getting out to the public-health labs.
But what I would say is that even if everything had worked perfectly, even if that system had worked just as it was supposed to, CDC had gotten a test out in a very timely fashion, it worked, and the public-health labs were able to stand up those tests, we’d still be in a very difficult situation and maybe precisely where we are right now.

Why?

Because what needed to happen was someone needed to decide at some point, probably in January, that this pathogen could become an epidemic here and start standing up the clinical labs and the academic labs.

What if you had been at FDA in January and February?
What would you have done differently?

Well, look, it’s easy — Hindsight’s easy and it’s easy to opine sitting outside the agency.
But what I was feeling outside the agency and what I was tweeting about was doing exactly what I said — getting the clinical labs in the game and getting the academic labs in the game.
So those are the kinds of things I was advocating from the outside.
And I probably would’ve been working the same kinds of issues from the inside.

Do you think that the FDA made a mistake by not allowing private labs to stand up testing earlier, to be able to scale testing earlier?

Yeah, I don’t know where those decisions were made.
My hunch is that the professional staff at the FDA and the career staff at the FDA very much wanted to get these labs in the game.
I know how they operate.
I know how they think.
And I’m hard-pressed to believe that the scientific staff didn’t want to find a way to get the academic labs and the clinical labs stood up earlier and try to develop a point-of-care diagnostic earlier.
Now, why that didn’t happen, I don’t know.

Look, I mean, there are some who speculate that it wasn’t the professional staff at all that’s to fault but it’s some of the political staff, and that there are some reports that the President, not wanting to hear how dire some of the prognostications could be, made individuals who are in positions of power, political leaders, hesitant to make him aware of some of the real threats because they didn’t want to risk being fully honest with the President, knowing he didn’t think it was in his political advantage to have a pandemic.
Do you think there’s anything to that?

I just don’t know.
I mean, you know, I wasn’t there.
I haven’t asked these questions.
I try to look forward, not back.
The things that I thought we should be doing in January and February, I said in January and February.
Now, come April, I’m saying what I think we should be doing in August and September.

We need to be looking forward, I agree with you.
But there is a certain degree of learning from our mistakes, that we don’t make the same mistakes again, and that’s all I’m trying to try.

Right.
And I think — I think the lesson is, we didn’t do what we needed to do in January to prepare for April.
We shouldn’t — We should make sure we do in April what we need to do to prepare for August.
And I’m not sure we’re doing that.
And so absent a lucky breakthrough with a drug, come this fall, we’re going to be at a lot of risk for big outbreaks, potentially.

Well, so let’s move on to therapeutics, treatments, vaccines.
I want to point you to something Dr. Anthony Fauci said just this week.
Let’s take a look.

I don’t think that you’re going to have to say that the country cannot get back to a real degree of normalcy until you absolutely have a safe and effective vaccine.

Dr. Gottlieb, is it the consensus of the medical community that, as you’ve said, our best near-term hope is a therapeutic drug if not a vaccine?

A vaccine’s our best long-term hope?
I think if you want to be conservative, you have to figure that a vaccine’s a couple years away.
The platforms being used to develop the vaccines are highly novel.
We’ve never developed a vaccine against a coronavirus, so to think that we’re going to do that in some super-accelerated timeframe and mass vaccinate the entire population with a highly novel vaccine against a highly novel pathogen, I think we need to budget two years, and we need to understand what it looks like living with this pathogen for two years.
There is a potential that you can have a drug by the fall of more than one drug.
I think the subset of medicines that both could be available and could be impactful enough to actually affect the morbidity, the death and disease from this pathogen is a very small subset.

All right.
So, let’s talk about what some of those drugs are.
There’s currently no FDA-approved treatment for COVID-19, but several of the drugs are being tested in clinical trials.
And while I want to get into the various options, the drug the President has continued to tout is hydroxychloroquine, which is an anti-malarial drug.
It is also used to mitigate symptoms of autoimmune disorders.
Let’s take a look at what the President just said this week.

And the other thing that we’ve bought a tremendous amount of is the hydroxychloroquine — hydroxychloroquine — which I think is, you know, it’s a great malaria drug.
It’s worked unbelievably.
It’s a powerful drug on malaria.
And there are signs that it works.

So you have said previously that you are not an optimist about this treatment.
But just last week, the FDA did authorize the emergency use of hydroxychloroquine in certain cases where patients are hospitalized.
Do you support that move by the FDA?

Look, the data’s very early and very mixed on this drug.
And while we understand the safety profile of the drug, I think the important thing to keep in mind is this drug’s widely available, and it’s being widely used.
If you talk to physicians, a lot of doctors were taking it as a prophylaxis, off label.
A lot of doctors in Italy were doing the same thing.
Most patients that weren’t on some other protocol, they weren’t receiving some other experimental therapy that were hospitalized, were receiving this drug.
I’ve asked physicians informally if they’re prescribing it, and they’re prescribing it fairly widely here in United States and have been from the outset.
So if this was having a robust treatment effect and was going to help mitigate the impact of an epidemic, it’d be doing it.

This treatment is being tested.
When are we going to know for certain whether this treatment will be effective?

I’ve asked people this question.
I get different answers.
Most people think that there’s trials that should read out within a month that are going to be not definitive trials but more informative than what’s been done.
There’s been a couple of trials.
One has been retracted.
And that was the initial trial that people pinned a lot of hopes on.
It only involved six patients in the active arm.
One was a 30-patient trial that showed activity, some potential benefit, and another was a trial of similar size that showed no benefit.
So the publicly available datasets are very limited.
Now, again, I suspect that there is some private data that they have because it’s being so widely prescribed in the U.S., they’re probably extracting data from clinical records that just hasn’t been published yet.

You seem to be more enthusiastic about a different antiviral drug which is currently in its trial phase, remdesivir.
Is that right?

The aspects of how this virus replicates, we’ve drugged before.
We’ve developed successful drugs to interfere with those aspects of how this virus goes about making copies of itself.
So we should be able to do it here.
Remdesivir, we have a lot of experience with it in other settings.
It does appear, based on limited datasets, to be active against the virus.
Probably the place where a drug like remdesivir will have its biggest impact is if you prescribe it early in the course of the disease before patients really get sick to try to break off viral replication, before the virus has a chance to do more harm to the person.

You’ve also written about antibody treatments.

Right.

Do you think that an antibody treatment holds more promise than an antiviral treatment?

Probably in the long-term, no, but what I’m focusing on are drugs that could be available by August.
And if you look at the subset of drugs that could be available by August, really, this is it.
And the antibody drugs are attractive because it’s a fairly simple approach.
We’ve done it before against other viruses, including Ebola.
And the virtue of an antibody is it can be used as a treatment in early disease.
Probably when patients are very sick, it’s not going to be effective.
But it can also be used as a prophylaxis to prevent infection in people who are exposed.
And so it could be a bridge to a vaccine.

So you wrote in your op-ed last week in The Wall Street Journal that — and this is a quote — that a therapeutic drug ‘would be transformative, and it’s plausible as soon as this summer, but the process will have to move faster.’ So as the former commissioner of the FDA, what needs to be done in order for the process to move faster?

I think we need to have a different mind-set about how we pull these drugs through.
We need to be able to say, ‘These are the drugs we really need in the next four, five months.’ And we’re going to make a very deliberate effort to try to bring these products to development and to work very closely with companies in a way that we haven’t before.

What’s it gonna take for that to happen?
I mean, you’ve been the commissioner of the FDA, so you understand why regulatory process works the way it does now.
What will it take for it to be expedited in the way you’ve just suggested?

Well, I think the most important thing is for leadership to tell the professional staff, the center directors, who are exceptional, that that’s what you want, and ‘Do whatever you need to do, take what resources you need to take to make sure that we’ve done everything we can to try to expedite the development of these products.’ That should be the charge and the mission, and that should be the direction, because we need these therapies.
If we don’t have them by the fall, we’re in a challenge.

Does that direction come from political leadership?

Yes.

You’ve called in your roadmap to reopen for a national surveillance system for containment.
Could you just describe to us what a national surveillance system would look like?

Yeah, I think, in retrospect, we shouldn’t have used the word ‘surveillance,’ because it has the wrong connotation.
Really, what we’re talking about is health monitoring and having in place very widespread testing capability so people could get diagnosed with the virus.
They can go to their doctor.
There’s a point-of-care system there.
They can get swabbed in the office, in the convenience of the doctor’s office, and find out if they have it in a rapid fashion, not have to wait days to find out if they have this virus, especially if they’re presenting with signs and symptoms of coronavirus.

So that’s the key to a national testing system or a national surveillance system.
We use the word ‘surveillance’ in medicine, but it’s not the kind of surveillance I think you typically think of in other contexts.

This week, the major story about the coronavirus is how it is disproportionately hitting communities of color.
To what do you attribute this?

Well, I think that the virus disproportionately impacts people from lower socioeconomic groups.
And there’s a lot of reasons for that.
And I don’t know that we understand all of them and I don’t know that I’m gonna be able to explain all of them.
But first of all, it’s harder to social distance when you’re living in tight quarters, when you’re living in public housing.
You can’t separate from sick family members.
You can separate from other people.
I think a lot of lower-income Americans are forced to work through this.
You know, if you’re a checkout person on a grocery line in a store, you’re coming into contact with many people.

What are the public policy solutions, in terms of simply, you know, the healthcare response and the public-health response for those who are more economically disadvantaged?

I think a lot of the public policy solutions are going to be on the back end of this, unfortunately, now that the way this has ensued and trying to make sure that we support those communities that have been hardest hit by this virus and help people get back to work.
But, you know, there’s things that we could think about, in terms of how we implement policy.
So, one of the places where there probably is a lot of spread of the virus is on public transport.
Now there’s a reason why New York City and others have maintained the subway systems.
They have to for people to be able to get to work, essential employees and people who just can’t afford to travel other ways.
But recognizing that and recognizing that a lot of lower-income New Yorkers are now gonna be forced to continue to take public transport, which could become a vehicle for spread of this virus, we should try to focus more resources into those systems to do cleanings of those systems.

You know, you predict, based on what you know and you’re understanding of the virus and how it replicates, that there is a likelihood that it comes back in the fall.
How do you think that then plays into impacting our elections, our national elections, in November?

Yeah, I think we need to start thinking about this right now whether or not we’re gonna be able to crowd people into voting booths and into long lines in the middle of the cold in November.
Do we shift to mail-in elections or early voting in most states to allow people, to allow the voting to be spread out over a number of days where you don’t have to have big crowds?
Those are things we probably should be contemplating right now because there is a real risk.
I don’t think this just goes away.
This now recedes into our lives, and it’s become something that we need to deal with on an ongoing basis, again, until we can vanquish it with a vaccine.

Tell me, do you think that handshakes should go away, like Dr. Anthony Fauci just suggested?

Well, I was never a big fan of the handshake, and I carried Purell long before it was fashionable and would Purell after I shook people’s hands.
And I think sometimes people saw me do that and thought it was offensive.
But now you’re prudent.
So now that I have an excuse not to shake people’s hands, I’m gonna take advantage of that.

Dr. Gottlieb, ever the canary in the coal mine.
Thank you so much for coming to ‘Firing Line’ and for sharing your insights.

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