Former FDA commissioner: ‘We remain almost equally vulnerable to threat from the next pandemic’

I have to admit, I wasn’t ready to dive into a book-length account of the pandemic quite yet. Why did you decide to write it now?

I think we haven’t done an adequate job really reflecting on everything that went wrong that left us excessively vulnerable to covid, both the early spread as well as the continued vulnerability. We haven’t done a good job keeping up with the twists and turns of this virus and the emergence of the delta variant and how much it’s engulfed this nation. Part of the problem is we really haven’t looked at the more systemic shortcomings that left this nation weak in the face of this virus. I think a lot of the initial focus was on all the political failures. And while there was plenty of political mistakes along the way, especially by the Trump administration early in the epidemic, I think a lot of the very corrosive shortcomings were at an agency level, especially at the CDC, where in many cases we had an ill-prepared bureaucracy, and in other cases the institutions that we relied on just weren’t equipped and empowered to execute the kind of response that was needed. The result was that we remain persistently at risk in covid’s evolution. We remain almost equally vulnerable to threat from the next pandemic. I don’t think we’ve done anything to really think about how do we prevent the next pandemic. And I’m surprised that at a policy level, Congress and others haven’t started to contemplate what kind of steps we need to take that next pandemic. So I try to do that in the book.

What’s striking to me in your account is just how unprepared we were, given how much we thought we had prepared for a pandemic.

Well, we prepared for the wrong pandemic. We focused just on flu, and what we should have been focusing on was the whole category of viruses that replicate RNA and spread through respiratory droplets or aerosols, because, as a category, those viruses all have pandemic potential. They have pandemic potential because by replicating through RNA, it means they undergo rapid mutation, and by spreading through droplets or aerosols, it means they can spread very quickly, very widely. And so that’s a much broader category of viruses, of which coronaviruses are one part. And we had enough warnings that coronaviruses were evolving in ways that could potentially threaten us in a more sinister fashion.

You’re not impressed by the CDC’s performance over the past year and a half.

Well, look, it’s the wrong agency. I mean, in fairness to the CDC, we asked the agency to do things that we never equipped it to do, that it doesn’t have the culture or the mission or the mind-set to do. CDC is a high-science organization that does very exquisite retrospective scientific work to try to track outbreaks and do disease surveillance. Their cultural preference would be to gather all the information, do a very careful analysis, publish a peer-reviewed document giving a retrospective look at what happened that is bulletproof. They’re not an organization geared toward providing real-time, actionable information that’s partially informative in a setting of a crisis.

In a setting of a crisis, policymakers need whatever information they can get, even if it’s only partially informed information, because they’re going to have to make decisions regardless. And so you’d rather make the decisions in the setting of some information rather than the absence of any information. The CDC’s preference would be not to surface the information until it’s been carefully vetted for, in some cases, months. And so it’s just the wrong agency. And that’s sort of a personification of the mind-set that pervades everything that they do and how they reacted to this crisis. They’re just not an operational agency; they don’t have a crisis mind-set. They’re not capable of moving in a real-time fashion. So, yes, I’m pretty critical of the CDC in this book, but I think in fairness to the agency, it was the wrong agency.

Are you comfortable sending your kids to school?

I’m comfortable sending my kids to school. But I have a district that is very vigilant. I mean, masks are mandated, and my school will be keeping kids in defined social pods to try to reduce the likelihood of transmission within the school. My town will make use of testing. So there’s a lot of things that are going to be put in place. There’s been a lot of studies looking at what are the sort of ideal interventions to try to reduce the likelihood of outbreaks in the school. And that’s really what you’re trying to do. I mean, you’re never going to be able control the introduction of a single infection. Kids are going to get infected. They’re going to come to school with a mild or asymptomatic case, but what we want to do is control the risk in that setting. And the two single most potent interventions from some of the literature are keeping kids in defined social pods, so keeping kids within small groups, and implementing regular surveillance testing. So ideally twice-a-week testing, or at a minimum, once-a-week testing. Those two interventions probably give you the most bang for your buck in terms of risk reduction in the school setting

You wrote in the book that you didn’t want to assign political blame, particularly as events unfolded, but right now we have a number of governors who remain aggressively against masking mandates and against vaccine mandates. Is there any justifiable rationale for that approach to the pandemic?

No. First of all, I think it’s wrong of governors to intervene in ways that take away discretion of local authorities, local public health authorities. A very conservative principle is that the practice of medicine is something that the federal government deliberately leaves to the states, and the states empower professional societies and local governments to implement laws that would govern the practice of medicine. So to see anyone intervene to take away that local discretion, I think, is antithetical to conservative principles and wrong as a matter of public health. I certainly don’t think governors should be intervening to actively sort of thwart the kinds of steps that people might take to protect themselves, including wearing masks, including getting vaccinated. I think in the book I’m critical of specific actions that political leaders took that I felt were antithetical to a good response. What I didn’t want to do was make it another book about ‘it’s all the fault of the liberal governors, or it’s all the fault of Trump.’ Every book that I’ve read about covid looks at the response and the failures through a political prism. I wanted to try to avoid that. This isn’t a book where I’m going to say everything flowed from the political mistakes that were made, even though I obviously get into some of those political mistakes, and there are certain things that I found very objectionable, like, you know, the opposition to masks and the inability to have an informed discussion around masks, and the efforts to elevate hokey remedies like hydroxychloroquine over more established treatments.

The development of the covid vaccines has been amazing. We have an abundant supply of coronavirus vaccines in the United States, while other countries have almost no access to vaccines, and huge percentages of their populations are unvaccinated. You’re on the board of Pfizer. What responsibility do the U.S. and major pharmaceutical companies have to make vaccines available in those countries?

Yeah, look, I think we need to be much more proactive about getting the global population vaccinated. And this will very soon no longer be any question of our supply. It’s a question around access and the capabilities on the ground to distribute the vaccine, particularly a vaccine that requires some complicated storage requirements. And to the extent that we see vaccine hesitancy in the U.S., there’s going to be a lot of vaccine hesitancy in other markets when we try to deploy Western vaccines into some markets. And in fact, Brazil refused to allow the Pfizer vaccines into that market, and so did India for a long time. There’s going to be ample supply of vaccine over the next couple of months. I think the Western manufacturers alone are going to produce probably 15 billion doses. The issue is going to be [distribution] on the ground. And we need to start paying much more attention to that.

What’s giving you optimism as we move forward?

Well, first of all, the pace of the technology. I think we’ve had tremendous success being able to track this, target [covid] and develop vaccines against it. We’re going to be able to develop drugs that can be taken as a pill and prevent progression of severe covid, or even prevent onset of infection in people who have been exposed to it. Much like we have Tamiflu for influenza, we’re going to have a drug like that for coronavirus. We’re going to develop newer, better formulations of these vaccines that are going to have better characteristics in terms of storage requirements and are going to potentially confer even more durable immunity, are going to potentially allow us to vaccinate against a compilation of variants rather than just a single variant as new variants emerge. And so we’re going to develop better antibodies that target certain regions on the virus so the virus can’t easily mutate around them. So the technology is going to get a lot better. And I think in a lot of parts of the country, you’re starting to see a consensus emerge around what we need to do to improve our protections against respiratory pathogens. Generally, we’re at a point now that this virus will become endemic. We’re going to go from the pandemic to the endemic phase of this virus. And delta may be the last major wave of this virus. And we’re going to see ourselves evolve into a more endemic phase where this just continues to be an omnipresent risk and a continual threat, but not as pervasive as it is now.