In This Episode
The COVID-19 vaccines have put the FDA front-and-center in our national COVID-19 response. Between the lag for full COVID-19 vaccine approval, the approval of a questionable new Alzheimer’s drug, and the booster it’s worth asking where the FDA goes from here. Abdul talks to Dr. Scott Gottleib, former FDA Commissioner and author of a new book about the pandemic.
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Dr. Abdul El-Sayed: Cases continue to trend downward in the hardest hit states in the country, even as hospitals teeter at the brink. As new evidence emerges about the efficacy of boosters, an FDA panel recommends them for people who are immunocompromised or over 65, but not the general public. Three moderate Democrats are trying to tank legislation to empower Medicare to negotiate prescription drug prices. This is America Dissected. I’m your host, Doctor Abdul El-Sayed. In theory, in our democratic society, our government is by the people and for the people. That system of government may lend to a lot of chaos and noise as the will of the people shifts every two to four to six years, but in theory at least, it should deliver the goods and services that people need to live dignified lives. But the nature of that idea, by the people and for the people, has always been contested. After all, at the very moment that those ideas were being written, women, Black people, even non-landowning white men, weren’t considered people at all. And because there were explicitly excluded from the conception of the people, the government has long since failed in ways big and small to serve them. Today, though there’s no doubt that we’ve made strides in establishing far greater representation for women, people of color, sexual minorities, and low-income people, we still remain so far from true representation. And part of that is because the growing power of major corporations. Back in 2010 in a landmark case, Citizens United versus the FEC, the Supreme Court interpreted the 14th Amendment to protect businesses as people and interpreted the First Amendment to protect money as speech. Their ruling opened the floodgates for cash from large corporations to influence our politics. Today, big corporations spend billions of dollars in efforts to elect politicians who support their aims. And those politicians rarely forget that. It’s putting yet more pressure on an inherent tension in our democratic government. On the one hand, we expect the government to operate in an objective manner dictated only by the best interests of the people. On the other, we leave government’s basic decision making and operations to a political process that is increasingly greased by the money that corporate largesse can offer. The point of maximal tension sits in the agencies of government like the Food and Drug Administration. The FDA has a unique responsibility to keep the food we consume and the medications we take for our health, safe, effective and secure. There is, of course, one right way to do that. That’s science. Science offers us the tools we need to objectively ask and answer questions about safety, efficacy and security. In theory, no amount of campaign contributions, political pressure, or misinformation should shake the scientific process on which these decisions are made. And yet this happened just last week:
[clip] Two of the senior officials who really led the vaccines unit within FDA have announced their retirements because they felt frustrated that the FDA was getting front run on the booster decision by the White House, and to some extent, the CDC as well.
Dr. Abdul El-Sayed: Before that, there was this:
[clip] The FDA just approved a new drug to fight the major cause of Alzheimer’s, despite concerns about the cost and its effectiveness.
Dr. Abdul El-Sayed: Oh, and don’t forget this:
[clip] Why hasn’t the CDC and FDA given the COVID vaccine anything more than emergency use approval?
[clip] Health experts say full approval may encourage more people to get vaccinated.
Dr. Abdul El-Sayed: The FDA has found itself at the center of a number of high-profile controversies regarding whether or not to approve vaccine boosters for healthy Americans, how long it took for the FDA to offer full authorization for the vaccines in the first place, or its recent approval of a new controversial Alzheimer’s drug despite a startling lack of evidence that it even worked to slow cognitive decline. The good folks who make the FDA what it is, career civil servants who are among the top in their classes in science and medicine, care deeply about getting it right. At the same time, though, they don’t operate in a sterile vacuum. The world, its corporations, its public pressures, it pressures them to sometimes just get on with it, but also to rule in this direction or that. Worse, they often have to answer to folks who don’t understand or don’t even believe in what they do. And they have to contend with the fact that their decisions could cost billions of dollars. Understanding that space where science, politics, government and society meet, well, that’s the whole point of the show. And today we’re going to talk to someone who sits squarely between them. A couple of weeks ago, Dr. Scott Gottlieb, the former FDA commissioner who served between 2017 and 2019 under Donald Trump, reached out to me asking to be on the show. Needless to say, we don’t see eye to eye on much. After some discussion with our team and some reflection about what the mission of the show really is, I decided to take him up and have him on. I believe we always learn more from engaging with those with whom we disagree rather than pretend their perspectives don’t exist at all. Our discussion after the break.
Dr. Scott Gottlieb: So I’m recording now, so . . .
Dr. Abdul El-Sayed: All right, fantastic, and I am also recording. All right, let’s get started. Can you introduce yourself to the tape?
Dr. Scott Gottlieb: Scott Gottlieb.
Dr. Abdul El-Sayed, narrating: I wanted to use this opportunity to speak with Dr. Scott Gottlieb, former FDA commissioner, board member of Pfizer, and author of the new book “Uncontrolled Spread” to offer a perspective you don’t usually hear. We discuss the operations of the FDA, his time in the Trump administration, the relationship between government and politics, and his new book. Our conversation may sound a little bit different than you’re used to. And that’s because I wanted to focus on fleshing out the spaces where we differ so you can make a decision for yourself.
Dr. Abdul El-Sayed: For listeners at home, the FDA just seems like this black box and you wait for it to say certain things and and then it does or it doesn’t. Can you demystify the FDA for folks who may not know how the institution functions and what it does?
Dr. Scott Gottlieb: Hey, look, it’s a complex organization, and I think that’s why people on the outside sometimes perceive the decision making process as being opaque. A big focus of the agency’s efforts over the last few decades, really, and certainly over the time that I was there to try to bring more transparency to how decisions got made. And the advisory committee meetings, for example, are a big part of that, where the agency goes before a public, a public group, group of its advisers and sort of articulates its rationale for making certain decisions and makes all the information that forms the basis of its judgments, public. But different decisions get made through different processes. I think with respect to the drug approval decisions, sponsors conduct clinical studies, those clinical studies are required to be made public. So there’s public awareness of what studies are being undertaken. There’s public scrutiny of the protocols. Information gets submitted to the FDA. The FDA has different review clocks in terms of how much time it commits to taking to review different kinds of applications based on the way the applications filed, based on the priority that the agency assigned to the application with respect to how important the product is, and has user fee goals, has commitments that it’s made to Congress about how long it’s going to take to reach a decision—and those commitments aren’t how long it’s going to take the agency to reach a positive decision, it’s how long is it going to take the agency to reach any decision—and so that there is predictability around the process.
Dr. Abdul El-Sayed: It strikes me that the pandemic has put an intense amount of scrutiny on the FDA. And it’s not just public scrutiny, but also it’s really pressured the FDA in ways that are unique, considering the fact that we are trying to leverage science in real time to make public policy decisions and of course, have medications, treatments and, of course, vaccines available to the public as part of the arsenal to take down this pandemic. What do you think the pandemic has taught us about both the strengths and also the weaknesses of the FDA?
Dr. Scott Gottlieb: Well, certain groups inside the agency, I think were frankly overwhelmed by the workload. And the vaccine division is one of them. The vaccine group inside FDA isn’t a very big group. There’s not a lot of vaccines that get reviewed and approved each year. It’s, there’s not a lot of innovation in the vaccine space generally. And so that division is small relative to other groups inside the agency and obviously had a historic workload over the past year. I think to your point about the political intrusions into the agency, I think that they were unfortunate political intrusions into the agency—around hydroxychloroquine, around the process by which the agency undertook its review of convalescent plasma—and I think that that unfortunately colored how some people perceived the agency’s decision making process. And also forced the agency into a position where they had to create really clear boundaries about how they were going to go about adjudicating a vaccine to make sure that the public remain confident in the process that they were using to evaluate the vaccine and that that had an impact on the review process for the vaccine product, because it really forced the agency to put out objective guidance before they really had an opportunity to get any data in at all, and they had to sort of delineate what the rules of the road were going to be. And I think that they felt compelled to do that because of the scrutiny that was being applied to the agency and because some of the unfortunate episodes that had occurred earlier with, particularly the hydroxychloroquine product and the convalescent plasma. So I think that the agency’s been under a lot of scrutiny. I think it’s been under a lot of pressure. A lot of it’s been political. A lot of it just has been a monumental workload. One of the, one aspect of agency—just to sort of finish the point—one aspect of the agency, I think gets less focus because a lot of people focus on the therapeutics and the process by which the agency went about evaluating the vaccine, I think one part of it is the diagnostics group, which has issued emergency use authorization for literally hundreds of different diagnostic products that we use to help control the pandemic. And so the workload foisted upon that division has been historic as well. And I think people sort of don’t appreciate how efficient they’ve been going about trying to bring these new diagnostic modalities to the market—including point of care, diagnostics and things people can use in their home, where they’ve really changed the regulatory paradigm for those kinds of products.
Dr. Abdul El-Sayed: I want to ask quickly about some of the technical questions around speed and accuracy at the FDA and then and then jump over to some of the bigger political questions as well. You had recently suggested that we have to be a lot more responsive around the ways that we design and execute on clinical trials for situations like this. Can you talk about your approach to thinking about how we could speed up clinical trial processes, and how does that compare to what we have right now?
Dr. Scott Gottlieb: Well, it’s not just a question of speeding up clinical trial processes. I think in the setting of a public health crisis of this magnitude, we need to have trials designed in a way that they can be executed while doctors are delivering crisis levels of care, and that patients are going to want to enroll in. And we conducted literally hundreds of clinical studies that were never going to yield definitive answers. They weren’t properly designed, they weren’t randomized studies, and they were just designed in a way where you weren’t going to get objective information that could help change medical practice. And so a lot of patients were diverted to clinical studies that were never going to impact the practice of medicine. And meanwhile, therapeutics like the antibody drugs by Regeneron and Lilly, which were very important drugs, which people had a lot of hope were going to impact clinical practice, and in fact did end up providing a significant treatment benefit to patients—those trials were hard to enroll because they were randomized trials, patients didn’t want to enroll in those studies, they were conducted in a very rigorous fashion with a lot of data collected so doctors had a difficult time enrolling and [unclear] those studies in the setting of a crisis. So I think we need to think about how we conduct studies and design studies in a way that they can be enrolled and completed in this kind of an emergency, and where they’re going to be designed in a rigorous enough fashion that they’re going to yield definitive information that can actually impact medical practice. And the British got it right in this regard with the recovery study. The recovery study was a practical clinical trial. Patients were randomized not to placebo, but to different active therapies. So patients had an incentive to enroll in the study because they all knew they were going to get some active therapy. And the trial didn’t try to boil the ocean. They didn’t try to collect 200 different variables on the patients. They tried to collect the information that was most pertinent to answering the relevant question, which was does the treatment work or not? And in fact, many of our most important answers about therapeutics, including demonstrating that a drug as simple and as cheap as steroids can help improve outcomes, can help save lives in patients who are requiring oxygenation as a result of COVID. Many of the most important clinical answers, certainly the early clinical answers that we got, came out of that single recovery trial. So I think we need to think about how we conduct studies like that and also how we give some authority to groups like the FDA and the NIH to basically favor those studies, to say, look, you guys, you might want to conduct three hundred different studies, but these are the five studies that we need to conduct because we need answers to these questions and we’re going to ask you to bias enrollment in these studies. And just to sort of finish the point they made at the outset of about hydroxychloroquine, that drug was clearly demonstrated not to work in the treatment of COVID but how many studies did it take for us to finally arrive at some level of consensus that the drug didn’t work? Literally hundreds of studies were conducted with hydroxychloroquine and because we didn’t have a definitive answer around that up front early on, the sort of mythology around that drug was allowed to persist for far too long. And now some of that is even hard to pierce once the definitive information became available.
Dr. Abdul El-Sayed: Yeah, what I hear you saying is that there’s a trade off between control, oversight, speed, and size. And in these kinds of high pressure situations where clinicians and policymakers are making decisions on the fly in the midst of an emergency situation, we really need high oversight, high speed, a little bit less control, and a little bit potentially less size, unless we can get it.
Dr. Scott Gottlieb: And the recovery trial is a good illustration of those tradeoffs and the US didn’t participate in the recovery trial because we didn’t deem it sufficiently rigorous. But I mentioned that the recovery trial, the British recovery trial, came out with that result showing that steroids can help save lives in patients who have advanced COVID disease. Well, in that trial, they didn’t collect information on whether or not the steroids caused the patient’s blood sugar to go up, because we know when you give steroids to patients, their blood sugar goes up. It’s one of the, it’s one of the known side effects of the drug. And the people who conducted the study said, why would we collect information on a variable when we know it’s going to happen and we know doctors are going to treat it? The US regulators, or the US trials would have said, well, how could we not collect that data variable, because maybe the magnitude of the increase in blood sugar correlates with whether or not you’re driving the treatment benefit. But once you start going down that path of trying to collect information on all the variables that can impact the outcome that you’re most interested in, you end up with a trial design that’s hard to conduct in the setting of a crisis. And so that’s why we didn’t get a lot of research early. A lot of the most important answers were coming from clinical studies conducted outside the US.
Dr. Abdul El-Sayed: And there are also, those studies end up being super noisy. I want to ask you if you had to sort of offer a grade to the FDA in this particular moment, what would you give it? And if you were back in the saddle running the FDA or advising the Biden administration, what is the principle two or three things that you would want to see changed immediately?
Dr. Scott Gottlieb: Look, I think the FDA did really admirable work under extraordinary circumstances. And I can’t even imagine what the environment was like there. There’s no crisis that we managed of anything near the magnitude of what they went through over the past year. So I think they did an outstanding job against a very hard set of circumstances. Are there things that could have been done differently, looking back objectively, I wish I was there, I would have done this? Sure. One of the things that I think could have happened early on—and this really wasn’t the FDA per se say, I think this was more a failure of leadership above the FDA—but early on, someone in January needed to say this may be a pandemic, we need to start getting the commercial manufacturers who develop test kits, who develop diagnostic tests, engaged in this and starting to make tests right away. Because we know that’s going to be a four to six week process, even if they’re fully engaged in trying to mass manufacture diagnostic tests. Because if this does become an epidemic in the US, those test kits are going to be very important to getting people diagnosed and staging a proper policy response. That didn’t happen. That phone call wasn’t made. Now, could the FDA commissioner have made that phone call? Probably. But really that phone call should have come from even above the agency. And so there were things like that where I think there were steps that could have been taken, but it didn’t really fall within the FDA’s purview. Could a different commissioner have made different decisions around that? Potentially.
Dr. Abdul El-Sayed: I want to switch tack here. The FDA has been in the news quite a bit recently, whether it was how long it’s taken for them to go from emergency use authorization to full approval of the vaccine, or even the conversation about Aduhelm, the new Alzheimer’s drug that was approved, despite the fact that the advisory panel overwhelmingly voted against it. And they raised a couple of important questions. Even now, we’re in the midst of a debate about the boosters and the fact that the director and associate director of the vaccines unit resigned over questions of the booster. All of this sort of points to the fact that implicitly, when you’re working in a moment like this one, the impact of politics and public discussion are going to vary and as are the impact of corporate interests and public policy. And so I wanted to ask a couple of questions of that. As you think about this ongoing debate, first and foremost about the booster, where do you fall on that and where do you think the administration or those FDA officials may be wrong?
Dr. Scott Gottlieb: Well, and as you know, I’m on the board of Pfizer, which has submitted an application requesting authorization or approval for a third dose of the vaccine. And a lot of data that’s informing the discussion is coming out of Israel where they exclusively used the Pfizer vaccine. So I’m of the opinion that there is evidence of declining efficacy for people who have been vaccinated a long interval ago, particularly in older individuals. And that may be the population that you want to look at boosting. I think with respect to the administration and I, I don’t think any of us really understand the basis for the resignations, but I interpreted some of the commentary around that a little bit differently. I think with respect to the Bush administration, they needed to have an approximate date when boosters might be made available. There’s sort of an emerging consensus in the public health community—I believe, I think this is a fair statement—that for older individuals who are vulnerable, who were vaccinated along interval ago, a booster can provide benefit. And we’ve made that decision, obviously, with immunocompromised, moderately, severely immunocompromised patients. So if you accept that, just accept that for a moment that that’s truthful and there’s a general consensus around that, if the administration wants to be in a position to say we’re going to start giving nursing home patients boosters, they need to know probably four and maybe six weeks in advance what the approximate date is that they’re going to start rolling that out, because it takes that long to operationalize that. So the administration saying that by the end of September or some point in October, having an approximate timeline in their mind and sort of articulating that is important because all the planning needs to begin. And if you look back what happened in the Trump administration, when the vaccine was authorized on December 12th, I believe—the Pfizer vaccine was first authorized in December 12th—we didn’t start vaccinating in the nursing homes for another probably about three or four weeks. And at that point, we were losing about 7,000 people a week in the nursing homes were dying of COVID. Why didn’t they start vaccinating on December 13th? The vaccine was authorized December 12th. The supply was there. Because they didn’t have the logistics in place. They had to go in and get the consent form signed and consent is so hard to get nursing homes, a lot of patients don’t have capacity for consents, you have to call the family. So it took weeks to get that in place. So I’m sympathetic to where the administration was trying to have an approximate timeline. My interpretation of some of the commentary around the resignations was if there was frustration, it wasn’t necessarily frustration at the White House for trying to back into an approximate timeline. I interpret it as frustration more directed at CDC, quite frankly, where I think some FDA officials have been concerned and frustrated with CDC out of a perception that CDC has overstepped its traditional role and basically assumed some of the role of a drug regular. And this was most apparent, quite frankly, around the J&J vaccine when there were certain safety questions that had come up, and you basically had CDC adjudicating the safety questions and issuing sort of statements that constituted an update to the labeling of the Johnson & Johnson vaccine. When, in fact, that’s FDA’s purview. FDA should have adjudicated that information, made a judgment, updated the labeling, before CDC started to take on some of those tasks. And so that that becomes, that’s more than a turf war. I mean, there’s consequences when one agency steps in front of the other agency. And did I have moments like that? I did. And I sometimes had to have very direct discussions with the CDC Director or heads of other agencies when I felt that they were taking actions that were stepping in front of FDA, taking away our prerogatives, but also doing it in a way that could harm the public health.
Dr. Abdul El-Sayed: So I agree with you that having the logistics thought through around how to deploy a vaccine booster should a vaccine booster be authorized and recommended is important. I also agree with you that there’s relatively strong evidence that demonstrates, as Dr. Fauci put it, a diminution of effects around a two-dose regimen in seniors and people who are immunocompromised. The step where I think there has been some broad disagreement is around whether or not a booster is recommended to healthy Americans more broadly, and particularly considering the opportunity cost of every dose that’s given. Every third dose given to a relatively healthy American is a first dose that’s not given to someone in a country abroad where access to vaccines has been particularly low and that, you know, that can’t be divorced from a lot of the economic consequences of selling a third dose vaccine into a higher-income country like the United States versus a lower-income country like India or Vietnam or Chad. And I guess that is the place where I think there has been some broad disagreement. What do you make of that conversation? Obviously, I know that you are a board member at Pfizer and so in some respects I see that question, but the evidence just doesn’t feel like it’s fully there. And it does feel like there are ways that one could have worked out the operational questions quietly before recommending publicly that there ought to be a booster.
Dr. Scott Gottlieb: Yeah. And I think, you know, the administration really has just talked about boosters in the context of older individuals, senior citizens, and where they’re trying to operationalize some preplanning is mostly around the nursing home. So I think that they, there hasn’t been any statement that would suppose that they think boosters are something that should be for 30 and 40 and 50-year olds. And I agree with you, the data there is still unclear. I think, where there is a clear signal among older individuals. And the debate in the public health community right now is this is as I see it: clearly, we’re seeing rising break-through infections, even among those who’s vaccinated. And it’s probably some combination of a vaccine that is now six, seven, five months old in individuals and a much more contagious variant. But what we’re not seeing for most people, with the exception of some older individuals, people over the age of 70 in most recent CDC data, is a decline in the protection against severe disease and hospitalization. And the original premise of the vaccines was that they’re going to protect you from dying and they’re going to protect you from getting severely ill. And that premise is fully intact. The secondary premise of the vaccines, which we didn’t know at the time that the vaccines were first approved, is that they were also going to protect you from getting any infection at all and they’re going to protect you from spreading the infection. That thesis is what’s been pierced as a result of Delta and probably as a result of an aging vaccine in more individuals. And so the debate that I see in the public health crowd is should we be providing a booster just to restore that second premise when the first premise, the whole basis for developing these vaccines and authorizing them in the first place still appears to be intact for the vast majority of people. And I think that’s the debate that’s happening right now. And I think it’s a reasonable question.
Dr. Abdul El-Sayed: The other problem, though, is that we don’t have evidence that suggests that we can actually uphold that second premise, that third vaccine dose—
Dr. Scott Gottlieb: In perpetuity.
Dr. Abdul El-Sayed: —actually reduce the probability of spread. I haven’t seen any evidence to that effect.
Dr. Scott Gottlieb: Right. Well, I think, I think you’re going to see data come out of Israel, and there has been some data out of Israel showing that the third dose seems to restore some of the original assumptions around a reduction in infection, and if it reduces any infection at all, it’s going to reduce transmission. I think where the questions become from some in the public health crowd is, is it going to be durable? Just like we’ve seen that sort of premise decline over time with the second dose, is it also going to decline over time with the third dose? And really what these vaccines are providing is protection against symptomatic disease, severe disease, and hospitalization. On your first point about the using a vaccine here is a vaccine that could have been used globally where there is a more acute need, where you have more of a population that hasn’t had any vaccine at all—I’ll say two things to that. First of all, it’s not a zero-sum game. The reality is that the United States has already bought 200 million doses of the Modern vaccine, 200 million doses of the Pfizer vaccine. They’re not going to let those outside the US. The Biden administration is going to hold on to enough vaccine to re-inoculate the entire population as a matter of national security, just as a hedge against what we don’t know. So it’s not like using one dose here is taking a dose away from somewhere else that it could have been used. And the second point I’d make is that I think the issues around the global vaccine distribution question and challenge is going to very soon become an issue of distribution and not supply. We there’s been 5.8 billion doses of vaccine already used globally. 380 million doses just used in the United States. So a good portion of the world population has already been vaccinated. Over the next 12 months, Pfizer has said they’re going to make four billion doses. Moderna said they’ll make three billion. AstraZeneca is going to make billions. J&J now in partnership with Merck is going to make billions. Sanofi is going to enter this market and be able to make billions of doses. The Serum Institute in India is going to make billions of doses. China is going to fully vaccinate their own population and Russia the same. We’re going to have a lot of supply and the challenge is going to be getting vaccines into austere settings and also convincing a global population to take Western vaccines. We see the hesitancy here in the US around vaccines. We’re going to encounter the same challenges outside this country. And I don’t see the investment in the infrastructure that it’s going to take to really vaccinate a global population because talking about lead time getting into nursing homes, lead time getting into austere settings globally is going to be even longer. We should be making those investments right now.
Dr. Abdul El-Sayed: I don’t disagree. I don’t disagree with that point. I do think, though, that it is, demand is a function of time. You go back six months and people are clamoring for the vaccine and you check in today and there’s more than enough to go around to the point where we’re actually, unfortunately, wasting doses. And so in some respects, it’s not about whether or not we’re going to at some point in the long term have enough vaccine. It’s about whether or not we can get it fast enough to the people who need it in order to hopefully stave off the emergence of the next variant. I want to ask you just about the relationship between corporations and the FDA. Obviously, you were the FDA commissioner. You now hold the position on the board of Pfizer. And, you know, I would argue that that’s given you some or given Pfizer some advantage in terms of understanding how the FDA works and in having relationships inside the FDA. You know, where this potential breaking down of the firewall between corporate interests and the FDA was most egregious, was most recent with the approval of Aduhelm. We did a whole episode with Professor Kessellheim from Harvard about that. But I want to ask you in this moment where there is a lot of worry, a lot of lack of trust, do you think it’s appropriate for us to have such tight relationships between corporations and the regulators that are supposed to regulate them? And if so, why? And if not, what do we do about it when we’re in the situation where unfortunately we’ve seen it influence the decisions that the FDA is making?
Dr. Scott Gottlieb: Yeah, look, I don’t know the specifics around that particular drug decision and the interactions that Biogen had with FDA. I read some of the same stories that obviously you see in the media, but I don’t have any particular knowledge around that. I’ll say that the, you know, the processes inside FDA—so I worked at CMS, too, I worked at Medicare. Medicaid, right, and so I have a basis for comparison of just how public health agencies function. The processes around FDA were tightly controlled in terms of interactions. And what I mean by that is that there was a very clear process for how you interact with companies. Me as commissioner, I didn’t meet with individual companies. The meetings I took were either with trade associations or advocacy groups. I didn’t take meetings with individual companies. My calendar was public. I had a very clear process if someone wanted to petition me what they needed to go through, the layers that they needed to go through in my office, and the same processes were sort of maintained inside the centers. If companies wanted to come in, provide information to the agency, that was a very clear process for doing that. You needed to go through the program manager, you could appeal to the division director, it would go up to the director, go up to the center director. So most of the interactions were very tightly regulated. Are there examples where companies might have tried to go outside the process? I’m sure. And I’m sure there were examples where companies might have been successful trying to go outside the process. But that was very different, in my view that’s very different than a lot of other agencies where there is a back door and a front door and a side door. At FDA, there was a front door and most people were forced to go through the front door. You know, at CMS by comparison when I was there—and this is a long time ago so things would probably change there, too—the idea that a drug approval decision would be briefed to me before the decision got made, it almost never happened. The only time I got briefed on the drug approval decision was after the fact or sometimes before the decision, if it was going to be particularly controversial decision where they knew I was going to get asked questions about it, they would want to brief me because they want to make sure I understood and could explain the agency’s rationale. But the decision itself never came up to me. I would read about drug approvals by reading Biosentry or STAT. I would see it in Twitter, you know: FDA approved a drug. That was typically how I found out about drug approval decisions. By comparison in CMS decisions came up to the administrator. They were adjudicated in the administrator’s office. Much different process, you know, coverage decisions. And a lot of agencies were like that. So FDA had a very clear process and there was a deliberate process to keep decisions away from, certainly political officials like me, but even senior career officials so that the decisions got adjudicated and made at the appropriate level, and then they could be appealed up through those officials.
Dr. Abdul El-Sayed: I want to switch tack to your book. I thought your book was really well written. It’s thoughtful, it’s a thoughtful take on the pandemic. Certainly a different perspective for two pieces that I thought you didn’t quite talk through. And I wanted to just ask you about them here. You know one of the countries that you said got it right was the U.K., especially around the way that they were able to conduct and deploy the information coming out of clinical trials. Of course, the UK is very different from the United States when it comes to health care simply because they have a national health program. And the NHS does great work. It’s connected to the National Institute of Clinical Excellence. They’re able to to produce information, set up trials, read those trials, and then interpret them into health care decisions really quickly in a way that in our far-less centralized and corporatist health care system, we can’t. I want to ask you, you didn’t talk about the structure of our health care system and the ways that it interrupted our ability to intervene against COVID, nor the fact that we were ultimately unable to support our health care institutions in the way that they needed early on. And then, of course, the fact that public health institutions have been gutted in this country for decades. What role do you think the structure in our health care system plays in what we saw with COVID-19? And what would you get behind in terms of making our health care system a bit more resilient to something like this ever happening again?
Dr. Scott Gottlieb: Look, I think our health care system absorbed a tremendous impact. I mean, the New York health care system was almost breached, and you could argue was breached, but what it withstood was historic. I mean, the amount of death and disease in New York City, it became a COVID-only health care system. And I don’t think that the problems associated with collecting and analyzing and disseminating information were somehow exacerbated by the fragmentation of our health care system or that—we could have achieved a much better outcome with respect to how we collect and analyze information and even a better outcome than the US even within a health care system where we don’t have a single central electronic medical record. We didn’t use what we had effectively and there were a lot of things we did that were just the wrong approach to gathering information. Where I think our health care system was exposed, where the weaknesses of our health care system was exposed, was by virtue of the fact that COVID demonstrated that certain groups were excessively vulnerable to this disease. There were certain people who were disproportionately impacted by COVID. And that was a function of a lot of things. It was a function of low income, it was a function of racial bias in the delivery of health care, a function of structural issues in our society—but it was also a function of the health care system itself and the fact that certain individuals, certain groups, had a harder time accessing timely care, a harder time getting access to advanced care, than others in our society. And so you saw the disparities in the delivery of care in our society become very glaring as a result of COVID, because you saw the disproportionate impact that COVID was having a certain communities. I think that’s, if I take away sort of one lesson about the frailties of our health care system and our vulnerabilities and how we make ourselves more resilient going forward in the future against the future pandemic, that’s the one that I would put on top of the list.
Dr. Abdul El-Sayed: Wouldn’t you argue that that is a function of the way our system is organized? I mean, if you think about it right, we have multiple different tiers of systems. If you’re fortunate enough to be high income in this country and far, far more likely to be white, you are likely to be covered by a private health insurance corporation. That private health insurance corporation is likely to reimburse your care at a substantially higher rate compared to, you know, if you are low income, you may not have health insurance at all. You sit in that donut hole. Or you’re on Medicaid, which is of variable quality depending upon where you are, that on average reimburses at 50% of the value of care. And so, you know, in some respects, when you have a system that is as fragmented as ours is and you tier access to health care as a function of socioeconomic position, income, wealth—and we know that those things are patterned by race and ethnicity—you’re describing the system that we have. And one of the things about the UK, for example, or Canada, is that no matter who you are, you’re going to get the same high-quality care and you have far fewer disparities by race, ethnicity, socioeconomic position, geography, than we have in our country. And I feel like you’ve just made an argument as to why we do need to have some centralized backstop that at least treats everybody like it truly was equal.
Dr. Scott Gottlieb: Now, look, we have we have a centralized backstop in this country. We have the Affordable Care Act. We have Medicaid. I think there has been too little attention given in the past to the quality of care being delivered under those programs. And you just made the argument about Medicaid. In some cases, I’ve made the argument in the past that Medicaid, in some cases, depending on what your situation is, what your health situation is, is delivering an inferior benefit, is not delivering high-quality care. People push back on that. I think people are uncomfortable embracing the notion that Medicaid or the Affordable Care Act is delivering in certain respects for certain patients a subpar benefit. And I think we need to have an honest discussion about that and examine these public programs to make sure that they’re delivering on what they’re promising. Because you’re right, a Medicaid card in some settings is just a card. You can’t actually go use it because the reimbursement has been driven down so low that a lot of providers and communities won’t take Medicaid. And so a Medicaid patient has to go to a busy clinic. I practiced in a setting where I took care of a lot of Medicaid patients, my patients getting care was a whole day endeavor because they had to come see me, they had to go to a busy clinic, wait on a two-hour line in the clinic to get some treatment, had to go to the one pharmacy that would take their insurance on the other side of town. And so what is normally a two-hour visit for someone in the suburbs or one-hour visit ended up being an entire day. We need to look at that.
Dr. Abdul El-Sayed: Scott, I agree with you, right, that the problem is that public discussion about the low-quality care or reimbursement provided by Medicaid and the hoops through which people have to jump tends to serve into sets of political ideologies that say we should scrap the system overall. Right? And I would argue that you served under a president who tried to do exactly that. And if conservatives often had their druthers, they would cut these public systems overall and then use the argument for poor-quality care to argue that the public systems don’t work.
Dr. Scott Gottlieb: I don’t agree with that. I think that we have a consensus in this country. If we—I’ll rephrase that—if we didn’t have a consensus in this country that it was important to provide a high-quality benefit to Americans, that in a rich society, health care, people have a right to have access to high-quality health care, we wouldn’t have the programs that we have. Now, I know that there is some who still want to repeal the Affordable Care Act and would repeal Medicaid, but there are also a lot of people who feel that these programs aren’t delivering on the promise, that we ought to reform them to make sure they’re delivering on the promise. There might be better ways to deliver on that promise, but that promise is something that we should offer to Americans.
Dr. Abdul El-Sayed: You know, you and I will agree—I coauthored a book called “Medicare for All” which we argued that we should provide high-quality public insurance for everybody. So I’m glad to hear we agree on that. I want to just ask you one last point, right, and, you know, the sort of elephant in the room, pun intended, that we haven’t discussed is, of course, that former president under whom you served. And, you know, I get that when you serve in government, you don’t necessarily agree with the elected officials under whom you serve and you do your best to do your job and do it, do it well. But notably absent in your discussion of the pandemic was the—I’d argue—buffoonery and straight anti-science rhetoric coming from the very top of American government. And I wonder why why not just call it out, right? Because I would argue that path dependency is severe. And the fact that we got off to such a bad start on COVID and the fact that the pandemic was immediately politicized has led us down this path where we continue to struggle to try and get people vaccinated, we continue to struggle against the pandemic, and we continue to have some of the worst numbers in the world.
Dr. Scott Gottlieb: Yeah, look, I think I did call it out in a book because I have a lot of discussion in the book around the debate on masks inside the administration that I was a part of, where the president sort of undermined his own message on masks. He announced the CDC guidance on masks and then said he wouldn’t be wearing a mask. I talk about that and what happened. I talk about the episode involving hydroxychloroquine, the meeting I was in on in the Oval Office. So I think I did talk about the political erosion of the response, including the White House’s involvement in that political erosion. But what I tried to do in his book—a lot of people were going to tell the political story of the failures in the political leadership that led us to be excessively vulnerable to this crisis. I really tried to focus on the more systemic shortcomings and the structural features of government that left us excessively vulnerable, because ultimately we’re going to have to reform those. Ultimately, we would have had some of the same challenges, regardless of who the president was. And so that’s what I was trying to do in the book. You know, the, if I sort of had to summarize the biggest sort of negative influence, if you will, from the White House and the political leadership—and there were people in the White House who were very worried about this and I talk about some of them in the book, who I was engaging with it with—it was a lack of consistency. I mean, early on, early on we didn’t mount an appropriate response, there were things we did wrong, but ultimately we decided to do the 15 days to slow the spread. President announced that. Then, followed by the 30 days to slow the spread. So we implemented a nationwide mitigation because we didn’t know how far this was spreading, which was historic. We basically shut down the country for 45 days. So we went from that to by the end, by Election Day, the President was ceremoniously taking off his mask while he was still contagious with the virus. So it was the lack of consistency all the way through, and the ability to come up with some consensus around a set of measures that we could all agree on that was going to help mitigate some of the spread. And it wasn’t keeping the country shut down for a year. That wasn’t what we were going to do. But we needed to agree on certain things that we were all going to do collectively that was going to, on the margins, help control the spread until we could get to a point that we could vaccinate the populations. And masks were the most obvious. And getting, not just masks, but high-quality masks. Why couldn’t we get in N95 masks and KN95 masks to vulnerable people, senior citizens? I mean, there was no concerted effort to do that. So it was the lack of consistency, taking it seriously at one point and then by the end saying, you know, this is going to spread uncontrolled, that it’s inevitable—and it wasn’t inevitable.
Dr. Abdul El-Sayed: Well, I really appreciate you taking the time to to speak with me. And again, that was Scott Gottlieb, who’s the former FDA Commissioner and author of the new book “Uncontrolled Spread.” Scott, thanks for a vigorous discussion and debate. I hope we get to do it again, OK.
Dr. Scott Gottlieb: Thanks a lot. Thanks for having me.
Dr. Abdul El-Sayed: As usual, here’s what I’m watching right now: across the largely under-vaccinated southern states that have driven this Delta surge, cases are continuing to trend downward even as hospitals continue to struggle to care for the overwhelmingly unvaccinated people who come in with COVID. Here’s one tragic story from Alabama:
[clip] ICU patients outnumbered the beds available last week, making it very hard for people like Ray Demonya to find care. They called 43 different hospitals in three states. Now, they finally found room for him at Rush Foundation Hospital. That’s in Meridian, Mississippi, about two hours away from Coleman. Unfortunately, Ray passed away September 1st from a cardiac event.
Dr. Abdul El-Sayed: It’s a reminder that COVID doesn’t have to kill you directly. It kills indirectly every time someone’s turned away from a hospital because those who are unvaccinated put themselves and the rest of us at risk. Meanwhile, an FDA panel debated whether or not to recommend boosters last week. In a new study of people over the age of 65 from Israel, published in the New England Journal of Medicine, those who received boosters were 11 times less likely to be infected and 19 times less likely to be symptomatically ill with COVID-19. Based on this and other evidence, the panel recommended boosters for people who are immunocompromised or over the age of 65, but it ruled that it had insufficient evidence to recommend them for the general public. But you know what remains even more important? Getting people who haven’t been vaccinated at all their first shot.
Three so-called moderates are holding hostage new legislation that would allow Medicare to negotiate prescription drug costs. That’s not surprising considering the role of corporations in shaping our public policy. Representative Scott Peters of California took nearly $56,000 from pharmaceutical PACs. His colleagues, Representative Kurt Schrader and Representative Kathleen Rice, took $24,000 and $3,000, respectively. If you disagree with them and think that Medicare really ought to be able to negotiate prescription drug prices, you can go ahead and give them a call 202-224-3121 Again, that’s two zero two, two two four, three one two one and let them know what you think, that actually maybe Medicare, the biggest purchaser of prescription drugs in the country, maybe they ought to be able to actually negotiate those drug costs on behalf of the rest of us. But what do I know?
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America Dissected is a product of Crooked Media. Our producer is Austin Fisher. Or associate producer is Olivia Martinez. Veronica Simonetti mixes and masters the show. Production support from Tara Terpstra, Lyra Smith, and Ari Schwartz. The theme song is by Taka Yasuzawa and Alex Sugiura. Our executive producers are Sarah Geismer, Sandy Girard and me: Dr. Abdul El-Sayed, your host. Thanks for listening.