In the second in a series of video interviews on lessons from the COVID-19 pandemic, Brink Lindsey speaks with Dr. Scott Gottlieb, senior fellow at the American Enterprise Institute, former FDA chair, and author of Uncontrolled Spread. They discuss how the disastrous beginning of the U.S. pandemic response stemmed from fighting the last war: Previous efforts at pandemic planning focused heavily on an influenza pandemic in which rapidly ramping up testing would not have been such an important challenge. They also discuss the need for a national security mindset to guide pandemic preparedness and response—and the dispiriting evidence that American politicians and policymakers still have not adopted such a mindset.
Brink Lindsey: Hello, this is Brink Lindsey. I’m a vice president with the Niskanen Center, where I helped to direct our new project on rebuilding American state capacity. State capacity is a social science term for the ability to formulate and execute policy effectively. Nowhere have problems with American state capacity been more tragically obvious of late than in the response to the coronavirus pandemic. And so we’re doing a whole series of video interviews with different prominent experts on what went wrong and how we can learn from what went wrong, and occasionally what went right, in order to do better for next time, because there will be a next time.
So I’m delighted to be able to speak today with Dr. Scott Gottlieb. He’s a physician, he served as Commissioner of the FDA from 2017 to 2019 and is currently a Senior Fellow at AEI and a member of the board for Pfizer. Throughout the pandemic, he’s been a prominent commentator in the Wall Street Journal and CNBC, Face the Nation, and elsewhere – a real go-to source of insight and common sense during this dreadful time with such a high noise-to-signal ratio. And he’s the author of the superb book, Uncommon Spread, which came out in the fall.
Dr. Scott Gottlieb: Thanks a lot. Thanks for the interview.
Brink Lindsey: Also an advisor to a handful of governors on their pandemic response. So Scott, thank you so much for taking the time to speak with me today.
When we planned to do these videos in the spring of 2022, we were hoping it was going to be retrospective and we could look back. But alas, we’re still in the thick of things. We’re taping right now in the middle of March. There will be a little delay before this goes up, but right now Omicron seems to be on the way down in the United States, but we’ve just been through a wave of where we’ve had thousands die every day. We’re approaching a million dead. Here in Asia, I’m in Thailand, Omicron is setting record case totals in Thailand. It’s the highest daily case totals of the whole pandemic. Thankfully, it’s a highly vaccinated population, higher than the United States, so fatalities are pretty low. But in Hong Kong, things are miserable right now. In China, there’s tens of millions of people on lockdown. So before we go back, maybe you could just comment a little on where we stand right now, entering year three of the pandemic. What’s your outlook for these coming weeks and months?
Dr. Scott Gottlieb: Well look, I think what’s going to happen in the future depends on what happens with the virus itself and whether the virus continues to evolve in ways that evade our immunity. At this point in the United States, we have a very tall wall of immunity. Not only have a lot of people been vaccinated as well as infected, and in many cases, vaccinated and infected, but we have in the US a lot of depth of immunity. People who’ve been vaccinated in many cases have been infected with Omicron. Many people have been infected with Delta and Omicron. So there’s sort of a diversity of immunity, if you will. That is a very tall wall, kind of like what the UK experience is. And so the only way to really see I think uncontrolled spread in the US in the same way we’ve seen these dramatic waves in the past is if a new variant comes along that pierces the immunity that people have acquired.
And that’s going to get and more difficult for this virus. The virus has shown us a lot of its genetic diversity. And so if the base case is that future mutations happen within that Omicron lineage, you have a population that’s already been heavily exposed to it. The immunity that people have acquired through vaccination, we know wanes over time. The immunity that people have acquired through infection with Omicron is also going to diminish over time and so there’s a risk that as we get into the fall and the winter, you start to see infection rates climb again. Maybe because there’s some future mutations within the Omicron lineage, probably because there’s some decline in immunity and you also don’t get the benefit of a seasonal backstop. As the weather gets cold, people crowd together indoors, it’s easier for respiratory pathogens to transmit.
So I would expect to see that this is going to surge again as we enter the fall and the winter, certainly not like what we’ve seen in the past. But for now, I think the base case is that you’re going to see continued declines. Now in the nearer term, you’re probably going to see an increase in infections through the months of March and April, because B2, this new Omicron variant, which is more transmissible but not any more dangerous than B1, the Omicron that was widely epidemic here, is starting to become more prevalent. It’s now 50% of cases as we sit here on March 18th.
In part because we’ve lifted all the mitigation, so people are interacting more and that’s going to be conducive to spread, and in part because there is some decline in the immune protection for people who’ve been vaccinated or have been boosted or been previously infected. And so they have declining immunity. But the most prominent features are going to be the relaxing of mitigation and the replacement of B2 for B1, which is going to drive an uptick in infections. I wouldn’t expect it to be a very sharp wave of infection, but there is going to be some increase in infections before we start to see continued declines as we enter the late spring and into the summer.
As far as the what’s going on in Asia right now, it really is I think a tale of two cities when you look at, for example, South Korea and Hong Kong. And it kind of speaks to what happens when you do and don’t have a population that’s heavily vaccinated. In Hong Kong, you have a population where two thirds of those over the age of 80 have not been vaccinated….
Brink Lindsey: It’s crazy, right? It’s the exact inverse of how it should be.
Dr. Scott Gottlieb: Exactly, especially this far into the pandemic. And you have vaccines that have been deployed that are proven to be not as effective against the Omicron variant as the vaccines that we used in the West. And overall, the vaccination rates are about 60% have been fully vaccinated, about I think 30% have been boosted, somewhere around there, in Hong Kong. And the result is that Hong Kong has experienced about, in the month of March, they’ve experienced around 300,000 infections, a little bit more than that, and 3,000 deaths. The death curve in Hong Kong is sharper than the death curve in the UK in the first wave, before there were vaccines, and in New York City. It’s the highest death toll per capita on a case basis that we’ve seen at any stage in the pandemic in any city.
In South Korea, by contrast, has a very high vaccination rate. Only 9% of the population over the age of 80 hasn’t been vaccinated. About 80% of the population overall has been vaccinated. I think about 60% have been boosted. So very heavy vaccination rates. And there you’ve seen around 5 million infections over the month of March, but only 3,000 deaths. A comparable level of deaths, 10 times the number of infections with a comparable number of deaths as Hong Kong. And South Korea, mind you, has a population, as you know, of 50 million and Hong Kong, 7 million. So Hong Kong has witnessed a devastating toll. And the biggest variable that is different between the two regions really is the rate of vaccination. And Hong Kong mirrors China.
Brink Lindsey: Absolutely. Do you have a sense of where China stands? Does China have this problem of vaccine hesitancy among the elderly like Hong Kong does? Or is Hong Kong an outlier?
Dr. Scott Gottlieb: Yeah, I don’t know if it’s so much vaccine hesitancy. I don’t know culturally whether there is a reluctance to use the vaccine. I think it relates more to just the logistics and the ability to distribute the vaccine. I don’t know that there’s necessarily cultural hesitancy as we’ve seen in some other parts of the country and in parts of this country though. But China does, to your question, China does have similar vaccination rates to Hong Kong, where about 50% of those over the age of 80 haven’t been vaccinated and the level of people who’ve been fully vaccinated and boosted is comparable to Hong Kong. And again, the vaccines that have been deployed are different than the vaccines that have been deployed in the US. What is being demonstrated is that they’re far less effective against this Omicron variant.
Brink Lindsey: Right. So let’s go back to the beginning of the story, at least the beginning in the US, and the testing debacle. So that was the original sin of the US response. The CDC was going to make a diagnostic test. They told everybody else to back off, we’ll do it. They bungled it, bungled it a couple of different times, stood in the way of other organizations developing their own tests for a while, and things really never recovered from there. So in a well-functioning US public health system, how would it have gone? What would’ve been the ramp up to go from the initial stage… I assume things would’ve started at the CDC, but they have to branch out into universities and labs and then branch out into commercial manufacturing. How should the playbook have run?
Dr. Scott Gottlieb: Yeah. Well, a lot of… I mean, you’ve summed it up well. A lot of our original woes during that first wave were the result of not having an effective diagnostic to deploy. Not only the public health problems we face, but also the cultural problems we face and the pushback against the mitigation. We were unable to target the mitigation and applied it far more widely than we should have and needed to. And that created some backlash to what we were doing, and the backlash was warranted. We were shutting down parts of the country that didn’t have a lot of spread at that time, simply because we didn’t know, because we couldn’t get a test deployed.
The old playbook had CDC always going first and deploying a test against a novel pathogen. The way it worked was that CDC would manufacture a test in-house because it would be the first entity to have access to the samples of a new virus. If capacity, if demand for a test exceeded what CDC was able to supply – and CDC would largely supply tests to hospitals and public health authorities – if demand exceeded that, CDC would start pulling laboratories into the game, into the market. And if you still had too much demand, then they would start pulling in outside manufacturers that could mass produce a test.
And this is in fact the playbook that they followed for Zika, and it didn’t work real well. We didn’t have enough testing for the Zika infection, and that was an infection that was largely slow moving because it was spread through mosquitoes. It wasn’t a respiratory pathogen that moved quickly through a population. This was never going to work with a novel respiratory pathogen.
Brink Lindsey: When was the US Zika experience again? When was the Zika scare in the United States?
Dr. Scott Gottlieb: Zika was probably… I’m going to forget the exact dates. It was around there, yeah, 2013, 2014.
Brink Lindsey: 2014, something around there?
Dr. Scott Gottlieb: I had been out of FDA the first time, it was during the Obama administration. But we were never going to be able to have enough tests for a fast-moving respiratory pathogen if we followed that playbook. So the question, your question is, what should we have done? I think we needed to have a system more akin to what South Korea did. And South Korea handled that first wave very well because they got a massive amount of testing deployed quickly. They started manufacturing tests at scale even before the virus had first arrived. And the way they did it was their playbook that they had put in place following their brush with SARS and MERS was that they would have a rapid handoff to industry and that there were programs in place to subsidize the production of tests by industry participants.
So you very quickly pivot to the mass manufacture of diagnostic test kits that could be deployed to any lab. And they standardized the test kits across labs so that they maximized the installed base of testing equipment that they had in those labs to run the most number of tests it will. Because there’s a diversity of testing platforms in the labs, so you need to have test kits that are going to run on the biggest number of testing platforms, because each test is sometimes unique for different kinds of testing platforms.
We had no such playbook here in the United States. First of all, we had no capacity in place for CDC to do a commercial handoff. CDC itself had no awareness of the commercial testing landscape, so they had no insight into what platforms labs were running and how you would maximize the installed base of testing equipment. It just was never contemplated. CDC historically has worked with public health labs and hospitals. They never worked with the commercial lab market and historically they never made tests for any entity other than hospitals and public health labs. So for example, when they manufacture flu tests every year, they hand those off to public health labs and hospitals. They never interface with the commercial marketplace.
Brink Lindsey: A fascinating thing I learned from reading your book was the extent to which this blind spot about testing was a kind of fighting-the-last-war problem. To the extent we had a pandemic response playbook, it was produced during the Bush 43 administration, and it was really, really focused on a flu pandemic, and influenza’s different from coronavirus in important ways. The incubation period’s less and also coronavirus has this incredible variability in spreading. So you have these super spreader events. So for coronavirus, asymptomatic transmission is a much bigger deal than for flu. With flu, you know who’s sick. They get sick within a day or two. They present with symptoms, and then you can trace from there if you’re going to do that. But the idea of having this enormous blind spot that you don’t know who’s spreading the disease wasn’t on anybody’s mind.
Dr. Scott Gottlieb: Yeah. That’s a good summary. Again, flu has a very short incubation period. So by the time you can get someone diagnosed, they’re already symptomatic and they’ve already probably come into contact with some other people where they’ve propagated the infection. But in the case of this novel coronavirus, it had a long incubation period, and you were most contagious when you were pre-symptomatic. And so the diagnostic test became much more important to try and contain spread in the setting of this coronavirus because people were spreading it when they were either asymptomatic or pre-symptomatic. And so if you could be testing more of those individuals before they manifest symptoms, you could take them out of circulation, get them to isolate, before they’re going to go on and spread the virus.
With flu, you’re most contagious after you’ve manifested symptoms. By that point, you’re identifiable, and the incubation period’s very short anyway. So the time between exposure and infection’s very short. So most people are going to manifest symptoms very quickly after they become infected and after they become con contagious. And so the diagnostic test is less important in stopping spread.
Now I was part of that plan in the Bush administration. I was young at the time, working at FDA as a senior advisor of the commissioner, but was peripheral to what was going on. And at that point, and in all the subsequent tabletop exercises, even the ones I was part of when I came back as the commissioner of the agency and as the deputy commissioner of the agency, when we exercised to model a pandemic, it was always involving influenza. So we were always prepping for a pandemic that would involve a flu. And with a flu, the diagnostic test wouldn’t be that important. Not only because of the reasons we discussed, but also because the nation’s installed base of flu testing would be sufficient.
So we never modeled, how do we scale up diagnostic testing? Because you have a huge installed base of flu test testing. Those flu tests in every doctor’s office can differentiate influenza A from influenza B. If the pandemic strain of flu that’s circulating is an influenza A, then you can use that installed base because all you have to do is diagnose that someone has influenza a and if that’s the prevalent strain that’s circulating, you just assume it’s the pandemic strain. You don’t need to do sequencing to figure out if that’s the strain that people have. They come in. They’re symptomatic. They have all the signs and symptoms of the pandemic flu that’s circulating. You test them. They have influenza A. You know they have the pandemic flu.
So we never said we would need testing because we knew we had a big installed base of testing. So what was new, what was different here was, all of a sudden, you had to grow up an installed base not only of PCR testing, but also the capacity to collect respiratory samples outside of the healthcare setting, which we didn’t have. South Korea had mothballed that. They facilities ready to pop up where they could do massive collection of respiratory pathogens. We had nothing of that sort.
Brink Lindsey: So I get that pandemic planning started with an influenza focus, understandable. But then had MERS. We had Zika. We had Ebola. We had a bunch of pandemic scares that were completely different kinds of threats. So it just seems baffling to me that we were caught so unaware.
Dr. Scott Gottlieb: Yeah, what was baffling was that we had never really contemplated that you could have a pandemic involving a coronavirus, even after, to your point, SARS and MES. Now, SARS and MERS never acquired the ability to spread efficiently from person to person, but they were highly pathogenic. But it wasn’t a great leap of imagination to conceive of the possibility that there could be a coronavirus that came along that combined some of the pathogenicity of SARS and MERS with the ability to spread as efficiently as a seasonal coronavirus. This is the four seasonal strains of coronavirus that circulate.
And what we should have been looking at was not just influenza, and not just coronavirus for that matter. We should have been looking broadly at the category of pathogens that replicate through RNA and that transmit through respiratory droplets or aerosols. And the reason why that category of pathogens is important when you’re doing pandemic preparedness, to think about it from that broad, macro perspective, is that any virus that replicates through RNA is going to have the potential to mutate very rapidly and undergo changes in its features because of the replication through RNA. That process lends itself towards a lot of mutations through replication cycles.
And any pathogen that spreads through aerosols or respiratory droplets has the potential to rip through a population very quickly. And so any pathogen that combines those two features, it replicates through RNA and spreads through respiratory droplets, has pandemic potential. And if you’re thinking about it from that vantage point, the universe of viruses you need to worry about is not only influenza, not only coronaviruses, but it’s a little bit broader than that. There’s other viruses that fall within that bucket if you’re talking about viruses that replicate through RNA and spread through respiratory droplets or aerosols.
Brink Lindsey: So April 2020, it was looking like the Trump administration was gearing up for a big national push on testing, but then for various mysterious reasons, mostly, apparently, having to do with political calculations, they junked all of that and devolved testing responsibility to the states.
Dr. Scott Gottlieb: I was having a lot of communications with the White House at that point. I was talking to them up through, maybe, April, May. And so I didn’t have great insight into everything that was going on, but I had some insight. And I think that the prevailing narrative in the media was that the administration pulled back from testing because there was this view that the more you test, the more cases you’re going to uncover. And the more cases you uncover, the worse the epidemic looks. I don’t think that was what was driving the administration’s decision to push back from the table a little bit. I think what drove their decision to push back from the table, at point in time — maybe that media narrative was a little bit more true later on heading into the election – but at that point, April/May 2020, I think there was an understanding that it was important to get diagnostics into the field, that people wanted to know if they were sick.
There were a lot of consumers that were symptomatic, and they wanted to know whether they had COVID. And they were bitter at government for not providing those tests. I think that what drove the decision to push testing out to the states and push back from the table was a recognition that they simply couldn’t do it. They had made an initial foray to stand up testing sites and to get the commercial manufacturers engaged, and they just couldn’t scale it. We didn’t have the capacity to do it. And so I think that there was a political decision to say, let’s get out of this game and try to just push this to the private market and to the states to figure out because we’re not able to run this out of the White House.
Brink Lindsey: So counterfactual, we’ve got President Clinton in office, who’s got no issues with trying to downplay the epidemic or skepticism about testing. Let’s say she was 100% committed to, we need to scale up testing as fast as possible. Do you think, in that counterfactual, we still would’ve stumbled badly just because we had never tried this before and the organizational hurdles were just too much for us to overcome on the fly?
Dr. Scott Gottlieb: Not necessarily, but I think the mistakes were made much earlier. If you go back and you look at some of the original things I wrote about COVID, I started writing at the end of January about how we need to have a massive effort to start scaling the development of diagnostic tests. This was back in late-January. My first piece in the Washington Post, I talked about developing point-of-care diagnostics and how important testing was going to be.
Brink Lindsey: Right.
Dr. Scott Gottlieb: And this was the world that I came out of. I had worked this issue before. And if you want to a diagnostic test for a novel pathogen, the lead time to that is about six weeks, even in the best of circumstances. So if we wanted to have tests available for the beginning of March, the process for making them needed to begin in January, not in March. And the problem was we didn’t start really focusing on trying to scale testing until March.
That’s really when the administration started to push major resources. And there was this broad awareness that, oh my God, we don’t have testing in place. We needed to have large-scale testing in place at some point in mid- to late-February to prevent the seeding that was taking place at that point in time that created the disaster in New York, with a healthcare system that effectively collapsed in New York. So someone needed to pick up the phone around January 15th and call Abbott and Thermo Fisher and Labcorp and the other major labs and say, “Look, we’re very worried about this outbreak in China. We’re not sure what this is, but we think it could come here. We need you guys to start working on develop diagnostic test kits at scale right now. We know it’s going to cost you between 2 and 5 million dollars to convert a line and manufacture at scale. We know we don’t have funding in place to reimburse you, but we’ll try to figure that out. But you need to be good corporate citizens and do this and make this investment, even if you know you might end up losing money.”
This is why we have large major companies in this country. And we support them. I guarantee you, if the FDA Commissioner or HHS Secretary or someone would’ve made that phone call, the manufacturers would’ve gotten together and done this. Those phone calls have been made in the past. I had to make some of those phone calls when we had crises or impending crises, and most major companies will respond to that.
Brink Lindsey: Yeah.
Dr. Scott Gottlieb: That was never done. I have different theories about why it was never done, but the bottom line is it wasn’t done. And as much as people now say retrospectively, “Oh yeah, we talked to them. We were encouraging them to do this.” There was never a concerted effort to bring together the industry early on to do this. It didn’t happen until March.
Brink Lindsey: So that’s not the end of the failure of testing story. We also had problems with making mass availability of rapid antigen tests for home use and for self-diagnosis. That, at least technologically, was feasible a lot sooner than it happened. It was even organizationally feasible because in Europe they had widely-available, cheap, rapid testing months before we did. So how big a problem was that? Would that have saved a lot of lives if people could have tested themselves?
Dr. Scott Gottlieb: Yeah. Look, it was something we should have had much sooner.
Brink Lindsey: And what was the primary reason for the delay.
Dr. Scott Gottlieb: And again, go back to the reasons I wrote in January, talked about the idea of developing a readable stick. So like what we have for flu, where you can swab and get a diagnosis. We really didn’t start a concerted effort to push the manufacturers to make these tests, to start getting funding available for it until much later in the cycle. It really wasn’t a concerted effort until, I would say, late summer 2020. Early on, we were just focused on scaling the PCR testing, the lab-based testing. So again, it was this sequential process to the pandemic rollout, if you will, rather than an upfront and all-of-the-above approach in terms of trying to get testing into the market. Because you’re right, from a technological standpoint, this wasn’t a great feat developing an antigen-based test. We have the technology to do this. We’ve done this many times for viral pathogens, and we understood this viral pathogen well enough to be able to do that.
And then I think once we got those tests into the market, and I think this was one of the positive stories in terms of how FDA pivoted its framework and its mindset to get these tests into the market to make them available as home diagnostics, and I’ll get back to that. But once we got them into the market, we needed to step in and subsidize this market in a way that supply would continue to expand and wouldn’t just respond to normal supply and demand curves.
What happened was there was a big demand. Demand fell off. Supply fell off. Then when Omicron came along unexpectedly, we didn’t have enough testing because we had the biggest wave of infection we’ve ever seen in human history right at Christmas time when everyone wanted the test. But we should have accounted for that. We should have been stockpiling these, even if it meant we were going to end up throwing out a lot because they expired. We shouldn’t have found ourselves in this shortage situation.
I mean, we’ve never seen anything like Omicron. In a two-month period, 50% of the US population was infected. To put that into perspective, over the course of an entire flu season, about 15% in the high end of the population would be infected with flu, but that’s over a five-month period. We’ve never seen a viral pathogen rip through a population as big as it did over such a compressed period of time.
Now, getting back to the point about FDA, if you would’ve asked me at the outset of this pandemic, will FDA ever allow people to self-diagnose at home for COVID and not have a requirement that the result get reported somehow? I would have say nah, the regulator’s never going to get comfortable with that. The idea that you have a reportable pathogen and people are going to be able to self-diagnose for it with a test that’s not 100 percent predictive and is going to generate false negatives, they’re not going to do that. And yet they did it.
This was a sort of tremendous change in the regulatory mindset of recognizing that the overall public health good would be best served by making a diagnostic widely accessible to consumers. Even if it meant number one, some consumers weren’t going to report the result – and a lot of them weren’t going to report the result – and number two, many consumers wouldn’t take appropriate action based on the result, and number three, many consumers or some consumers would get a false result. They would be told they don’t have the virus when in fact they do because these tests aren’t 100 percent.
The FDA recognized that the public health good would be best served by making these tests widely accessible. That was a very significant change in regulatory mindset. I think it’s going to be a paradigm change going forward because you’re going to now see tests into the market for not just COVID, but for strep, for influenza. People are going to be swabbing at home for a whole host of pathogens now because FDA has changed the regulatory framework and recognize that making these tests more accessible to consumers at the point of home serves the public health good.
Brink Lindsey: You say this was a real change in regulatory mindset, so it wasn’t there at the outset. It took the grim experience of this pandemic to effect that mindset change. So it’s a hard-earned lesson learned, but it does seem to be a shift there. Now, on the vaccine approval side, there’s the whole question about approval of the vaccine before the election. I think that’s tough to second guess how the FDA did things given the evident pressures of this decision being politicized, and the public health imperative of having the public have confidence in the vaccine.
Dr. Scott Gottlieb: Well, I mean, remember also a lot of that sort of pressure on the FDA was being whipped up by outside groups and individuals. You can draw your own conclusions about whether or not everyone’s motives were pure. I mean, there were people on both sides of this. On the one hand, you had the Trump administration talking about trying to get the vaccine approved before the election and linking it very clearly to the election, which I thought was not appropriate. Then on the other hand, you had a lot of people saying, “We’ve got to figure out… We’ve got to keep this from happening quickly.” You can sort of try to look at the individual people who were putting a lot of pressure on the FDA and ask yourself, “What was the sort of genesis of their angst?”
Brink Lindsey: So here’s a question, how about why did it take so long. You had this emergency use authorization, that’s a relatively novel form that was used to great effect in getting by FDA standards, very rapid approval, and getting these vaccines approved. But then like eight months elapsed between the EUA for Pfizer and the full approval in August 2021, during which time that shot had gone into hundreds of millions of arms without result. Also during which time, you were having the sort of building up of anti-vax sentiment and people worried about it, and people saying, “Hey, it’s experimental. It’s only got this emergency use authorization. It’s not really approved.” Mandates like from the military were hooked to whether it was fully authorized.
Dr. Scott Gottlieb: Well, look, it’s hard for me to say because I wasn’t inside the agency on the other side looking at what FDA was doing. I suspect that there wasn’t a full awareness of the importance of the full approval for all those policy reasons you outlined. Not that necessarily would’ve influenced FDA, but I’m not sure that people sort of fully understood what the implications were of having it hang out there as long as it did under an EUA. But the thing that happens… So underlying your question is, why does it take so long? What’s happening during this process? You were making the point, there’s a lot of clinical data. We’re now two years into this. Billions of people have been vaccinated. We haven’t seen untoward events that weren’t predicted or aren’t well understood. So why would it take so long?
What the FDA is mostly doing in that process is what we call the CMC portion of the review. It’s basically doing the long-term stability studies and the oversight of how the product is manufactured to make sure that it can be put into the normal supply chain. So when the product comes to market, when the vaccine initially comes to market, you don’t have six months stability studies on it because it hasn’t been out for six months. So in order to do long-term stability studies and make sure that a vaccine can sit on a shelf for six months and go from cold to hot, to cold, to hot, you actually have to do those studies. Those studies take time because you actually have to leave it on a shelf for six months, and then test it to see if there’s been any degradation in the vaccine.
Now, initially when it comes to the market under emergency use authorization, you don’t need that data because you know in a crisis, it’s going to come to market. It’s going to go to a vaccine distribution site, and it’s going to be put in an arm within like three weeks. So you don’t need to be able to prove that it could sit on a shelf at Cardinal Health for four months, then just sit on a shelf at CVS for another four months, and not be kept in quite the right temperature because as things move around, stuff happens. You don’t need to prove that. But if you’re going to fully approve it and put it into the “normal distribution channel” where those things happen, where products aren’t used right away, they sit on shelves for long periods of time, you need that long-term stability data.
Dr. Scott Gottlieb: That’s primarily… I’m not saying that’s only what was going on. There was a lot of other stuff going on. They were continuing to collect clinical data. They were looking at the safety and effectiveness of the vaccine for sure. But a large part of the reason why it takes so long is because you’re doing those long-term stability studies to show that it could sit out for longer periods of time.
If you remember, when Pfizer came to the market, and I forget… I’m obviously on the board of Pfizer, and I still forget the details. But it had a very short or shorter shelf life in terms of how long the label said it could stay out and how it had to be stored. It had to be stored at super cold temperatures. Then as time went on, all of a sudden that timeline got longer and longer and longer, and then they relaxed the provisions for storage. So it was able to sit in a normal refrigerator for an extended period of time.
The reason why they were able to do that was because as time went on, they had more and more stability data to prove that the vaccine didn’t degrade in any way as it was kept for longer periods of time in a syringe, or a bottle, a vial. As it was kept in a normal refrigerator as opposed to a freezer as opposed to a deep freezer. It takes time to do those studies. That’s a lot of what was going on as we went from EUA to full approval.
Brink Lindsey: So what’s the story with treatments? We’ve had approvals of a couple of treatments that looked very promising, Paxlovid and Molnupiravir. I don’t know if that’s how you pronounce it, but they don’t seem to be… Maybe I’m missing something, but I don’t hear about them in action at scale making a big difference anywhere. What’s going on? I mean, outside of the rich countries, we’ve got just billions of people unvaccinated, who are sitting ducks for this virus. So if there are like really effective treatments, we need to be able to scale those up. It doesn’t seem to be happening and why is that?
Dr. Scott Gottlieb: Yeah, and antibodies as well, the antibody drugs… I’ve written a lot, all through the spring and the summer during that first wave, about the need to try to scale production of antibody treatments. Because it was clear that the first therapeutic response to this virus was going to be through antibodies, and that we would have the antibodies before we even had the vaccines. Mark McClellan and I were writing a lot of articles about this, that we needed to start crashing massive production of these antibodies, and that didn’t happen as well.
So we never had enough supply of the antibodies during any wave of this infection. We were never able to use the antibody drugs in a prophylactic way as sort of a vaccine. An active vaccine for people who were immunocompromised or who weren’t going to get a good response from vaccines because they were immunosuppressed, and the vaccines wouldn’t allow them to produce a robust antibody response. The antibody drugs could be used to prophylaxis people. We never had enough supply to do that.
In terms of the small molecule drugs that you just referred to, Paxlovid and the drug by Merck, part of the challenge has been that supply only started to ramp as the Omicron wave was cresting. So we didn’t have a lot of supply in the market. So it was kind of rationed to people who were at very high risk. So there again, we didn’t mass manufacture it early, which we could have. There could have been resources to do that. Part of it is it does take time to build physician awareness and get physicians comfortable with prescribing a drug. We saw this with the antibodies, and we’ve seen this with the small molecule drugs.
Because these are under an emergency use authorization and not in normal commercial distribution, the drug companies aren’t there doing what they normally do, which it would be detailing physicians and educating them about how to prescribe it. They could do some of that under an EUA, but it’s more limited and more restricted what they can do. So you don’t have that kind of physician education going on. I think the adoption rate has been slower among doctors.
Brink Lindsey: So I know you’re pressed for time, so I want to conflate a couple of questions I had. I wanted to talk about in your book, you conclude with a vision for treating pandemics as a national security issue and for building in excess capacity to be able to surge for testing, PPE, vaccines, treatments. To plan for having that capacity available, so we don’t run into these horrible situations like we did with testing and so forth.
But in your book, that’s pretty much a national focus. But we’re in a globalized world and unvaccinated populations in poor countries are serving as reservoirs for possible new variants that can come back and bite us. So we’re not really safe until the whole world is vaccinated or treatable, particularly vaccinated. How does the fairly grindingly slow delivery of access of vaccines to much of the world, how does that experience influence how you think we ought to do better next time? How do we get global capacity to do vaccines before a pandemic?
Dr. Scott Gottlieb:
I think we need to have a bigger footprint for vaccine biologics manufacturing, generally. And some of that you want to locate around the world. Countries should have their own production capacity for vaccines. And some of it’s going to be in Western markets where you have the ability to maintain these things at a massive scale. And we just need to think about how do we maintain some reserve capacity and see this as a strategic priority, where we subsidize the overbuilding of facilities. So we’re not operating all these biologics manufacturing facilities at 100 percent capacity all the time, which is how we operate them now for maximal efficiency, so we never have any reserve capacity. And if we want to scale the production of something unexpectedly, we’ve got to take another critical product offline. And most of what’s made in these biologics facilities are important therapeutic products. You can’t just shut off production very easily. Although we did that in the setting of COVID.
I will say that there’s a lot of reasons why we want to have global distribution of a vaccine and of this vaccine. And the most paramount reason is to try to reduce global suffering from COVID, global death and disease from COVID. But the issue of new variants doesn’t perfectly correlate with the amount of spread around the world. Although obviously more spread creates more opportunity for variants to emerge, but the variants are emerging in sort of unique circumstances where it either had an animal reservoir that serves as a sort of sequestered reservoir where this is continuing to mutate and it sort of reenters human circulation. And that’s probably going on right now as we speak. Or we think that single person who became chronically infected with COVID and the virus was able to continue to mutate within that single host and then eventually reemerged. And in the case of Omicron, there’s speculation that it was someone who was co-infected with HIV, so they were immunocompromised and couldn’t clear COVID.
So it’s not just the total amount of infection that creates the opportunity for these variants. These variants could emerge when you have sort of the wrong person in the wrong place at the wrong time or the wrong circumstance, and not just because you have a high level of overall infection. So I think when we talk about why we should be distributing vaccines, the first reason should be because we want to end global suffering or reduce global suffering from COVID. Right now, the challenge with the global distribution of vaccines isn’t supply, although global organizations are still talking about the supply issues. Right now as we sit here, March 18th, the US government cannot give away the supply it has.
So they are sitting on probably hundreds of millions of doses of vaccine. Some of them were earmarked for donation, that the countries that they were intending to donate to can’t, aren’t taking, don’t want to take, don’t have the capacity to take, because we never invested upfront in trying to put in place a global distribution system on the ground. So all the things that the WHO should have been doing, going into these markets, getting local distribution in place, getting the cold chain storage in place, doing a lot of the advance work to educate the population, to try to build demand for the vaccine and try to reduce hesitancy, that really wasn’t done. All the early sort of browbeating and focus was on supply, supply. So now that we have supply, and supply’s been slowed to ramp up globally, but now that we have the supply, we don’t have the infrastructure to distribute it, and we’re finding that the doses that we have are going unused.
Brink Lindsey: So if ever there were a time we’re going to take this abstract threat of future pandemics seriously, it would be right now, still in the teeth of the present one. A year from now, five years from now, it’s going to recede and people are going to think about other things, and it’ll be much easier to put out of mind. But now is the time. Does it look like that realization has really hit our political leadership?
Dr. Scott Gottlieb: No. The bill that just pass the senate is at best a down payment on true pandemic preparedness. I think that we need to dramatically, we didn’t talk a lot about CDC, but a lot of the root of our woes here in the US was because of the CDC that didn’t have the capacity to respond to a crisis of this magnitude. I mean the wrong culture, the wrong organizational set up, the wrong capacities. And yet, we look to CDC to sort of quarterback this whole thing without recognizing that it was inadequate to the task. And if you look at the legislation that’s being worked on in Congress, it doesn’t fundamentally reprogram CDC. It doesn’t try to create new capacities there and maybe excise some existing obligations to skinny down that agency and focusing more on its sort of core national security mission, which it’s migrated away from in recent decades.
Dr. Scott Gottlieb: I think part of the problem is, and when I talk to members and staff is, I don’t think that there’s enough familiarity with CDC to really know how to reprogram it. I mean, Congress is going to need to step in. The administration isn’t going to be able to do this. It’s very hard for an agency to self organize and ground a complicated new mission on its own. Congress is going to need to step in and fundamentally reprogram that organization, maybe pull out the prevention function and give it to NIH, and focus FDA on its disease control mandate and more of its national security mandate migrated away from it in recent decades. But that’s going to require Congress to come in and really carve it up and give it new authorities, new resources in certain places, and maybe take away some of its authorities or obligations in other places and refocus its mission. And I don’t think that there’s adequate understanding of how that organization functions to do that.
Congress did do that with FDA about 20, 25 years ago with the initial PDUFA legislation. They worked with industry who had knowledge of how the FDA functioned in part to effect that. But Congress wrote very specific legislation on how to fundamentally change the function of FDA. And I think FDA became a much more professional organization, a high functioning organization, owing to that sort of congressional oversight and congressional leverage. But in that case, Congress, there were people on Capitol Hill who acquired a deep understanding of how FDA functioned. There’s nobody on Capitol Hill, I think who is, no Congressman or Senator who their core expertise is how CDC works. Maybe we need a Congressman who worked there. Maybe that’s the wrong person. I don’t know.
Brink Lindsey: So in light of that, I’ll let this be the final question. Is re-engineering the CDC the answer, or should it just be left to be this kind of research organization and you stand up an entirely new entity in the office of the president or somewhere that is the real quarterback?
Dr. Scott Gottlieb: Yeah. I mean, this is a political question as much as sort of a practical question, like what’s the best way to effect this goal. We need an agency that kind of is like the JSOC for pandemic preparedness and the Joint Special Operations Command that has a national security mindset and an operational capacity and doesn’t function like a school of public health, which is how CDC functions with their culture. And is the best way to get that to create a new agency or to build the capacity in CDC? I still think that the best way to get that is to build the capacity in the CDC. I think the idea of starting new agencies inside the government’s hard. Who’s going to supervise it? It’s going to end up being under like Homeland Security, which isn’t going to have the adequate scientific prowess to supervise it.
CDC already has a lot of this expertise and already has been looked to historically to effect this mission. So I think the idea of building a new capacity in CDC that is culturally distinct from CDC but within in the confines of CDC makes the most sense. And maybe pulling out some of the things that CDC does that are very far afield from that kind of national security mission mindset. Should CDC be working on smoking cessation and reducing heart disease? Well, they could certainly do it, but FDA has a set up for tobacco products, which is very focused on reducing smoking rates in this country. NIH does a tremendous amount of research on cardiovascular risk. I mean, there’s places where those kinds of aspects of their prevention mission can reside that you can kind of pull that out, put it in agencies already focused on those that work, and then start to focus CDC more on this kind of national security disease control mission. That’s what I would do.
That’s going to be very hard politically too, because there’s going to be people who say that we shouldn’t be pulling these things out of CDC, then they’re going to be given lower priority. And then there’s going to be reluctance in CDC to take on that more national security mindset, because they’ve deliberately migrated away from that.
I mean, historically CDC was conceived as that kind of an organization. The epidemiological surveillance service was seen as a component of the nation’s national security. If you ask people at CDC now, do they see themselves as a part of the national security complex in this country? I would bet most would say, no, that’s not what we do. To give you sort of one anecdote, CDC had to be pushed to develop a SCIF in the early 2000s to take classified briefings because there were people there who were reluctant to be in such obvious receipt of classified information. They were worried that if they were working with national security agencies, it might impugn their ability to operate overseas, where people might perceive them to be working with spy agencies. That’s the ethos of the organization.
Brink Lindsey: Right.
Dr. Scott Gottlieb: But that’s what Congress comes in.
Brink Lindsey: That seems like a hard culture to pivot into the moral equivalent of war fighting.
Dr. Scott Gottlieb: I mean, you can’t do this quickly, but you can do it over time by changing how an organization is chartered and what it’s obligated to report to Congress and where the new funding goes. And Congress can come in and start to evolve this agency in the same way I think it did very effectively with FDA, if you look at the 25 year time span of the User Fee legislation, where Congress successively reauthorized that with more statutory language about trying to evolve that agency.
Brink Lindsey: Well, I feel like I’ve just scratched the surface of picking your brain, but we covered a lot of interesting detail in a pretty abbreviated period of time. So thank you for that really high dose of information.
Dr. Scott Gottlieb: Thanks a lot. Appreciate it.
Brink Lindsey: And I appreciate your taking the time and look forward to keeping in touch.
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