The U.S. Fumbled the Early COVID Response in Two Major Ways

In the first of two exclusive video interviews, MedPage Today Editor-in-Chief Marty Makary, MD, MPH, of Johns Hopkins in Baltimore, discusses the strategy and public health messaging in the early days of COVID-19 with Andy Slavitt, former White House Sr. Advisor for COVID Response, past head of Medicare/Medicaid and the author of the recent book “Preventable”.

Following is a transcript of their remarks; note that errors are possible.

Marty Makary: Hi, I’m Marty Makary with MedPage Today. I’m here with Andy Slavitt who used to run CMS and has been a senior advisor to the Biden administration on COVID. He’s also the author of the new book “Preventable: The Inside Story of How Leadership Failures, Politics, and Selfishness Doomed the U.S. Coronavirus Response.” He’s also by the way, an editor of MedPage Today [editor’s note: Slavitt is a member of MedPage Today‘s editorial board]. Thanks so much, Andy, for all you have been doing.

Andy Slavitt: Great to be with you. I’m an admirer of your book, so it’s good to get to finally chat.

Makary: You’ve been really sort of at the center of a lot of stuff on COVID early on. I remember even as the pandemic was starting to mount, even rumors that there might be a pandemic, you were following things pretty closely, and I know you were concerned. How did you get first interested in taking a leadership role in speaking out on COVID early on when it was not even recognized to be a problem?

Slavitt: So I think I did what everyone else tried to do, which is help in any way that I could. And in my case, I had background in responding to large-scale crises, a lot of connection points inside the government and healthcare, and I called Jared Kushner offering to help. I think the other thing that I tried to do which was maybe a little bit different is, I think of myself more as an outsider than an insider. So I really tried to share the information that I was leaving with the public as things were going along, and very much tried to try to help in any way I could. There were a lot of people dying as we all know. And it’s no better time to ask how you can contribute in moments like that.

Makary: You were sort of right in the mix of everything with the masking debate. Masks have been such a scientific enigma initially and then sort of a political enigma. Looking back on the whole mask issue, which I know you followed closely, what do you think was our greatest failure there, or something that folks may not appreciate about the whole masking debate?

Slavitt: I think there’s a couple of things that are clear in hindsight. One is that, nobody loves wearing masks. I mean, you’re not going to find somebody who says, please let me wear something that makes my face sweaty. So the question was whether or not the inconvenience was worth it. And by the way, that was the debate that occurred all over the world. There wasn’t a country in the world that wasn’t having some form of that debate. Is the mask right, which mask, does it protect me, does it protect you, et cetera. And of course we had a shortage of the best quality masks, N95 masks, that’s another matter, but that was probably the original sin, because I think everybody’s quite convinced N95 masks would have protected everybody.

Our original sin was doing something that no other country did and you refer to it, Marty. And that’s that we turned it into a political identity issue. It would have been enough of a challenge if it was just a public health question, and there would been plenty of debate and plenty of people who didn’t like it or liked it. But, I think what President Trump saw in it was a wedge issue. Using it as a wedge issue to kind of put forward kind of how anti-establishment and kind of this sort of rebellious vibe, it made the conversation much harder to have. And it sort of poisoned the well to being able to have a public health conversation about masks, which again there would have been plenty of debate about it even in those terms. The problem became, in the U.S., at least, we couldn’t have that conversation.

Makary: Where we are today with masks, Andy, how are you feeling about things? It seems like there’s a trade-off between maybe wearing masks too long could jeopardize some credibility when we may need people to put them on again in the future. And at the same time, taking them off prematurely could have risks. So how do you feel about where we are now?

Slavitt: I feel like right now it’s an individual choice and it should be. We have very low prevalence of COVID in this country. Notwithstanding that things may change, notwithstanding Delta [variant], notwithstanding other potential variables at this current moment. And I think probably for most of the summer, in most of the country, we have incredibly low prevalence of COVID and people have been going through a lot. And for people who have been vaccinated, I think they should enjoy the freedom to follow the CDC guidance and not wear masks if that’s what they choose.

But I want to say something about CDC guidance. CDC guidance is one factor you should take into account. There are plenty of other things we do in life that don’t just follow the literal science. If you feel better wearing a mask psychologically, or if you think it sends a signal, or if you have kids, or if you want to make other people feel safe in public spaces, there’s plenty of reasons that you could choose to wear a mask that are perfectly okay. And I don’t think we should be side-eyeing people who choose to or don’t choose to wear masks. So for people who are vaccinated, I think the CDC science is right as of now you don’t need to wear masks, and I wouldn’t feel the pressure to put them on. But if you feel like wearing them, it’s absolutely okay.

Now, if you’re not vaccinated, it’s another story. And I think the first thing you ought to do is strongly consider talking to your doctor about why you’re not vaccinated, ask any questions you have, and hopefully you’ll make the decision to get vaccinated. But in the meantime, you’re at much more risk, particularly with the Delta variant. And in that case, I think it would be wise to wear a mask. I think I’m probably yelling into the wind with that, but that’s my perspective.

Makary: Do you think there has been some bureaucratic hurdles that were unnecessary, that we’ve learned lessons about that could be addressed in the future? Say if we have to get a better guidance or FDA approval around something in the future, are there some steps that we can streamline?

Slavitt: Oh, always … there always are. And we need a serious look back kind of objectively at every step. And to try to do that in as apolitical a way as possible. It begins with the fact that we had 12 million N95 masks sitting in our strategic stockpile when we should have had hundreds and hundreds of millions. And I was part of the budget requests after the outbreak of Ebola, I was part of the budget requests that Obama put together to restock the strategic stockpile, and the Republican Congress refused to do it.

And there’s a larger point here, which is not political, but the larger point is these sort of invisible investments in things that we think don’t matter, sometimes they do matter. And sometimes we don’t know why they matter until later when they do matter. But if we had had the the proper amount of N95 masks, first of all it would have protected healthcare workers, they wouldn’t have had to reuse them. Secondly, they would have been more broadly available. And I think that would have probably helped make the guidance a little clearer, at least that’s my suspicion.

And then we had the companies that were producing the masks not tracking them. And so we had a tough time pulling the trigger to get them. As I talked about in my book, 3M wasn’t always a great actor here. Many of their masks were going other places and were being turned around and sold in the black market at a time when we desperately needed them.

So that’s one, I think your second question is, if I interpreted right, is could the CDC do a better, clearer job on guidance? And I think there’s a lot to learn about public health messaging that we all need to get better at because public health messaging, it isn’t like regular communication. Before we have a vaccine or a therapy, all we really have are our words. All we really have are how we communicate with one another, how we relate to one another, whether or not we decide to get in a crowded room and yell and scream during the middle of a crisis.

And so if we lose trust by not communicating well, or if we don’t explain why things change as they change, which isn’t difficult for the public to understand — it’s a novel virus, we learn how it works, that it evolves — but that erodes trust if you don’t carefully manage it. So I’m quite sure that there’s a strong lesson in public health communication. And the reason I know that is because if you look at the countries that did better at this, they largely did better because they’ve been through public health crises before.

Makary: Which country would you say did the best that’s not an island country?

Slavitt: Well look, I think the entirety of Southeast Asia and you could call Hong Kong an island country, but the truth is it’s got the most direct flights and train-line directly to Wuhan as you know. So I think all of, all of sort of East Asia I think did better, not because there weren’t people flying into the country from China with COVID. There were, and from other places. But because they had the muscle memory, they had the reps in the country to simply know how to relate to public health crises. We were going through it all for the first time in our defense. We, I think for a long time, felt immune from crisis like this. And so I think we were, our response was a little bit more sluggish.

But even if you look at countries in Central Europe like Germany, which I think is a pretty good parallel to the U.S., it is obviously surrounded by other nations. It’s very, very diverse as you know. And yet I think [Chancellor] Angela Merkel did a pretty good job talking people through the science and the logic and balancing the needs of different communities. And when they shut down bars, they provided funding to the bars that they shut down so that everybody could be in it together. We didn’t do those things. And I think those cost us.

Makary: You mentioned that Andy, in your book Preventable, how testing was such a struggle early on. And one of those issues was that hospitals and universities really just couldn’t test people, even though they may have had the brain power and the technology to do so. How was that a factor in getting behind the eight ball early?

Slavitt: Well, it was the first big technical mistake we made, or one of the first major technical mistakes we made, because if we had an opportunity at original containment, and I don’t think that containment would have lasted entirely, but if we had an opportunity to keep the genie in the bottle for longer so people could have responded, it would have been very quickly identifying where the spread was. And we would have needed to have testing rollout pretty significantly.

And a lot is made of this parallel, maybe too much is made about this parallel, but the parallel between South Korea and U.S. is interesting in the following way. The same day we had our first identified case, what South Korea did was they allowed basically every lab in the country, university, national, et cetera, to develop tests and get them out there quickly and created a national system as we all know, we remember drive through testing. They also, by the way, purchase masks for everybody in the country. Again, rapidly. We made the decision, which I think turned out to be a very big mistake, to say that there would only be one test and it would come from the CDC. And the reason that was a problem is because we had to put speed over everything else at that point in time. And we were not treating this like a crisis within the Department of Health and Human Services, the way we should have. There was a leadership problem, but it was also an experience problem.

And so the one thing that I’ve learned in managing crises is you try not ever to have only one path out of the jungle, so to speak. So if you put all your eggs in one basket, which is this is the test we’re going with, then you better execute perfectly. And the problem in a crisis is you’re always going to make some mistakes. Your plan has to allow for some things to go wrong. And so if you had every lab in the country producing tests, if a few of them didn’t work, you still would have been in much better shape. When they made this decision to say, we will only use the CDC test, it put themselves in a very tough spot. And of course, that test didn’t work.

Makary: The research dollars were mostly driven towards vaccines early on, and a lot of the big clinical questions like, how does it spread and if masks work, the funding for that type of research lagged behind. Is that something where we could have done a lot better?

Slavitt: Really interesting question. And that’s a complex question because the question is at some level, should there be a national strategy and prioritization to help you with all of the above the the diagnostics, the therapies, the vaccines, and of course the public health communications and testing of what’s working. And the truth is your most limited set of resources is time, but as you know, every company in the world can’t do a clinical trial for their product. So you do have to pick winners.

And I know some people will look at that and say, whoa, what about the free market? What about unfettered capitalism? And this sounds like national planning. Yeah, it is national planning. It’s smart people being prepared and having a plan and effectively, one of the things that the team at [Operation] Warp Speed did well was they selected eight potential winners. And this is on the vaccine side, obviously. And they put their resources behind those, as opposed to having a free for all where they tried to take the FDA staff and stretch it across 50 candidates, they focused them on aid. They’re making a bet that among those eight would be the right ones. That was a smart move on [director of the FDA’s Center for Biologics Evaluation and Research] Peter Marks’ part.

Likewise, I think you can ask the question, what’s the role of and what’s the promise for diagnostics, and how much do we need to invest there — clearly more — and therapies.

Now, it’s interesting and it shows in the books, when Peter Marks, who is a career staffer at FDA, came up with the idea of Operational Warp Speed, because he’s a sci-fi nut, he presented it to [former HHS Secretary] Alex Azar at HHS. Azar’s incoming view before that meeting was that it would take too long to develop a vaccine and that they shouldn’t focus on vaccines, we should focus on therapies. To Azar’s credit after he heard Marks out, and Marks’ plan for how to get focused on developing vaccines more rapidly, Azar supported it and decided to fund it. And the rest is history.

Makary: How do you feel about unvaccinated kids going to school in the fall right now?

Slavitt: Well look, I think presuming that the FDA gives final approval for Pfizer and Moderna, or even just Pfizer and has a set of recommendations that the ACIP presumably will follow with a set of recommendations, and I’m interested in what those say. Because those should be developed independently and they should be developed with the process of smarter people that need people who are more focused on these questions clinically. I guess my perspective would be if we don’t have approval by then, the kids should be going to school in person. I believe it is unbalanced. Again, my opinion here isn’t the monopoly opinion, but my own view is that it’s unbalanced but safe for kids to be going to school. And probably with precautions in areas where there’s spread.

And as we learn more as we see what’s going on in Israel right now, if we believe that something different happens because of Delta, then I probably would make sure that the kids who were going to school unvaccinated were wearing protective masks and we were having some measure of public safety. So it’s gonna be a question that’s going to have to get answered obviously over the next month and a half or so.

Makary: One area of vaccine hesitancy has been that people sometimes argue that it’s under an emergency use authorization and not fully approved. Is the fully approved process something that should be reexamined here? Many are saying, look, there’s millions of cases out there. The safety profile is pretty impeccable, and maybe this process is being hung up on what they call the shelf life testing, which is to look at stability testing. And maybe that’s, if we could make that a separate approval, a separate label, maybe we could issue a full approval based on safety now.

Slavitt: I think the one thing I know for sure is that the people who are not getting vaccinated because they’re waiting for FDA approval don’t want people like me weighing in on what the FDA should and shouldn’t do. I think those are people who really want to see that it go through the full process. Because they are nervous. And what they’re nervous about rightly or wrongly is that there was something that was done that was expedient that wasn’t wise that hasn’t shown up yet. And look while you and I may be very confident that’s not the case — and I’m gathering you are and I certainly am, and that’s why we got vaccinated so quickly — it’s not an irrational thought for people to have. And I think we need to respect the fact that people come from a place where their process tells them that this should be a more considered decision.

And if people are feeling that way, it’s probably not my course to say, are they right or are they wrong to be concerned. It is my course to say fine, let’s let people see this evolve. And then if they feel the jury is still out to get there and continue to hopefully dialogue with the right people, with their physicians, with people who know things, as opposed to going on Facebook and reading rumors.

Now, your broader question is a good one, which is are there the reform opportunities for the FDA to shorten the process of approval. And I think that ought to be examined outside the bounds of the current crisis. Again, so it doesn’t taint people’s perspective on the process. But of course, I mean, as you know very well and as I know very well, there are always opportunities for the FDA to improve how they do their jobs.

I will say one final thing having run an agency. If you’re running an agency like FDA or CDC, the one thing you can be sure of is you’re always going to either be too slow or too fast for somebody, and oftentimes too slow and too fast at the same time. Why did they remove the mask mandate so quickly, why did they wait so long to move the mask mandate? They’ll hear them both. So, they’re in a position where they have to make what they believe to be the right call, because unlike all of the people outside the agency, they have to live with the results if they’re right and if they’re wrong.

And coming on TV and saying, oh, CDC should do this faster or do this slower, et cetera. That’s free and easy because if you ended up being wrong, you don’t end up having to live with the consequences. And as you know, because of your first question, when they have to double back and say, oh, we got to change this. It does come with a cost.