The Road to the New Normal: Science & Public Health
This article is part of an ongoing collaboration between the Colorado School of Public Health, the Denver Museum of Nature & Science, and the Institute for Science & Policy. Find all of our previous COVID-19 webinars and recaps here.
By nature, scientific research is a slow, steady and self-correcting process, built for the marathon rather than the sprint. Then, COVID-19 arrived. Over the past year, we've witnessed priorities and policies shift on the fly to concentrate on a singular goal like a modern day Manhattan Project or moon landing. Governments fast-tracked emergency authorization for vaccines. Public health officials and pharma companies became household names. Scientists raced to collectively publish tens of thousands of research papers, many of which bypassed peer review altogether. Grant dollars arrived in spades for coronavirus research while other projects were postponed indefinitely, perhaps never to be resumed. The long-term effects of this disruptive year of COVID on the scientific enterprise may not be fully realized for a decade.
In the first in our forthcoming set of episodes previewing the "New Normal," Dr. Harvey V. Fineberg, President of the Gordon and Betty Moore Foundation joined Institute for Science & Policy Director Kristan Uhlenbrock to talk about how the medical and scientific worlds have shifted as we eventually move beyond the pandemic.
This transcript has been lightly edited for length and clarity. Watch the full recording here.
KRISTAN UHLENBROCK: At the top, I want to acknowledge that this week, we passed a sobering milestone of 500,000 American deaths from COVID-19. So while we do see cases receding, we must maintain vigilance because this pandemic is not over.
Dr. Fineberg, I want to give you a few minutes here at the top to give your take on our current situation. How are we doing right now as a nation and as a globe?
DR. HARVEY FINEBERG: This pandemic is in a really critical moment of inflection. We're past the end of the beginning, but are we very far into the beginning of the end? That's a question for us to ponder. You mentioned a very criticalmilestone: 500,000 deaths counted officially in the United States attributable to the COVID pandemic. The actual number is very likely somewhat more than that because of undercounts of deaths, but it's a pretty serious number.
A century later, it's been incredibly hard. We say in public health that every statistic is a number with a tear attached. Every life lost is a serious loss. And it has repercussions throughout a family and a community. On top of that, the disruption to our economy has been so profound and affected so many individuals in such a dramatic way. And the crisis has extended to our educational system. I was delighted to hear your plan to look ahead to education because the disruption to children's schooling throughout the United States has been truly horrific component of this pandemic.
So, we are in the midst. We are, however, seeing trends of improvement that you also alluded to. In the second week of January this year, the average number of new cases per day exceeded 250,000. Now we're down below 60,000 per day of new cases in a trendline that has been almost a straight decline. So that's really encouraging.
What is not known at this time, and still a matter of speculation, is what will the force of the pandemic be as we look ahead in the next six to 12 months. On the encouraging side, we have the vaccine that is now been deployed in the United States, about 40 million initial doses. About half that number has gotten the full two dose regimen of immunization. We have the seasonal advantage coming into our summer, which for respiratory infections very typically is a season which is less severe in terms of the spread of the infection.
But on the other side, we know historically that these pandemics often go through periods of waxing and waning, and often can sustain for more than a year or even two. That's a reason why Dr. Fauci is warning that we may still be wearing masks for a number of months. That's what's behind that. And the main uncertainty today has to do with the arrival of the variants to the virus, which have different capacities for spread, for infectivity, and may be eluding our vaccines and may be harder to detect in our diagnostic tests. So that was a kind of monkey wrench into the plans. It creates a level of uncertainty that would give caution to any predictions about what the future course is going to be.
So in summary, we've been through a lot. We have suffered an extraordinary burden of mortality. The trends at the moment in new cases are improving and that means that in the weeks following, the number of hospitalizations improved and in weeks following that, the number of mortalities also improved. So that's good. But the uncertainty looking ahead, knowing the history of these pandemics and recognizing the wild card of varying strains of the virus — those are the uncertainties.
KU: Thank you for that. Dr. Peter Hotez, who was on earlier in our series talking about vaccines, made a staggering number that I hadn’t heard before, which is that the global vaccination of the whole world is about 10 years out. He felt that that would be a timeframe when maybe we really had this pandemic globally under control. Any reaction to that?
HF: Well, Dr. Peter Hotez is extraordinarily well informed. Great expert, and I respect his judgment enormously. In my own thinking, I make a differentiation between trying to project elements that depend on nature — which would include, for example, the future of these variant strains of virus — and elements that depend on human response and action. So, in the case of global immunization, yes: part of it is going to depend on the need, which is a natural phenomena, but a big part of it depends on the mobilization, commitment, and determination of nations and peoples of the world to accomplish the task.
In a sense, the speed of immunization will depend our capacity to produce an effective vaccine to distribute equitably and efficiently and to ensure that the resources that are needed reach every country, every one of those individuals. So, this is a factor that is under our control. It's not a matter of the natural world. And for that reason, I would like to hope that the response would in fact be somewhat accelerated. But it depends on the choices and commitments of our countries and leaders and individuals.
KU: So let's pick up on that and focus specifically on the U.S. Looking at our governance structure, understanding national versus state versus local authorities, what are our strengths here and what are our weaknesses when trying to manage a pandemic?
HF: From a global point of view, the threat of a Covid 19 pandemic really throws into sharp relief the strengths and weaknesses of different forms of governance and different cultural values, different attitudes, and levels of trust between a population and the government. When you look at the United States of America, our fundamental principle of constitutional government is a federal system. Sovereign states came together to form the union represented in the Constitution to assign certain powers to the federal government and it says that remaining powers are in the hands of the individual states. In hundreds of years of history, we've constantly had a tension and a struggle between the elements of sovereignty that adhere the nation as a whole to the federal system, and the elements of sovereignty with the individual states.
When it comes to a matter of a pandemic, of a national response within the context of a global threat, our federal system represents elements of strength and elements of weakness. Among the strengths are the fact that different parts of the country can experiment in different ways to advance on the problem, and we can learn from one another.
The weakness is that our federal system depends on a degree of coherence, uniformity, collaboration, and joint action across the entire nation, from the national level all the way down to the local government. The United States is not intrinsically set up with a command-and-control unified system of management, a response from the federal to the state to the local levels. It requires active participation, cooperation, understanding, and decision-making in a mutual way to achieve that kind of coherence. We generally do in national emergencies come together as a nation. We came together after 9/11, most recently in our memories, in a way that overcame all of the intrinsic political structural elements that keep us separate.
In the case of pandemic, especially where it was easy to add in the political elements — when the crisis was not only a health crisis but also an economic crisis, and we talked about the educational crisis — it created an imbalance of interests. The focus on the health and medical care side as compared to the economic setbacks created a political tension that has dogged us throughout the pandemic. And so, the U.S. is tremendously strong in individual innovation, cooperation at the individual levels, collaboration and willingness to try new things to experiment. But we have, by virtue of our constitutional structure, a natural set of divisions that when you're trying to manage a coherent national response, we have to overcome.
KU: And let's take that one step further and build on that and the global response and the global framework, including the WHO. We have a new administration in place. What’s your take on where we stand globally?
HF: You know, the World Health Organization has a dual mandate. On the one hand, it is expected to be the moral leader of global response to help with threats such as the COVID. At the same time, the World Health Organization is the product of its member states. It only has the authority, the money, the will to act that is represented in the collective will of the member states. So there's this constant tension between how far can the leadership pull the states, and how willing are the states to push that leadership in a case of a global pandemic. It is never solved anywhere until it is truly solved everywhere, and therefore if we even out of what we might call enlightened self interest want to overcome this pandemic, we have to be part of a global response to manage and suppress and overcome this global threat to health.
On top of that, of course, is the imperative from a humanitarian perspective of doing the right thing, to treat every life with the same respect and the same value, regardless of whether it happens to be in country A, country B, or country C. So, from both a humanitarian perspective and a perspective of enlightened self interest, they both compel us to a decision in the same direction, which is to actively engage and participate and to be part of a global solution.
How does that translate exactly into resources, into allocations of vaccines, into distribution of medical protective equipment and other necessary resources? These practical issues have to be played out in real time. In the ideal circumstance, a lot of these decisions — for example, about vaccine sharing — can be spelled out and codified in advance of a particular outbreak. Because when you do it in advance, without the pressure of the immediate crisis, you have a much better chance of coming to grips with a fair and equitable and acceptable arrangement from everyone's point of view. WHO tried that and has tried that with influenza vaccines. But now we're trying to solve the problem for COVID in real time under real pressure.
On top of that, there are certain practicalities. For example, the two currently approved vaccines in the United States have very strict cold chain requirements for their distribution, very low temperature of maintaining these vaccines. And that creates a natural barrier to their widespread use in many parts of the world. So we have to be both practical and humane. We have to act in enlightened self interest and are doing the right thing. So, we're in the midst of it. Right now, we have an administration in place today that has a very different attitude about America's place in the world, its participation, its responsibilities. It's a sense of partnership with others and I think we're going to see continued growth of commitment, among nations of the world, to provide the resources, the vaccines, the funding and the human capacity that will help many if not all countries cope more effectively with this pandemic.
KU: Was there an equitable plan in place for vaccine distribution before SARS-CoV-2, or was it a partial plan? I just want to clarify, or do you think there will be a solid kind of agreement in place after this?
HF: There have been partial plans, particularly with influenza, in which there are pre-positioned agreements on the part of different countries in terms of the vaccines that they will accept, the vaccines that they will utilize. But there were so many uncertainties with COVID-19, including the fact that they weren't anticipating that we would have a coronavirus that was as severe, as widespread, as complex as this one. And so there were no trained physician agreements and commitments, in part because there were no available vaccines. This is all now being worked out in real time.
KU: And in the future, it sounds like there's going to be a little bit of both, potentially some rough frameworks and then some real time adaptation.
HF: It's very hard to anticipate all the contingencies, for example the cold chain requirement, making some [advance plans] impractical. But we can do a lot better at putting in place many of the preconditions, the legal agreements, that would facilitate vaccination distribution in real time in the future.
KU: And also, just because we're speaking of the WHO, I had pulled up one of their situation reports from a year ago today, February 24, 2020. And it was focused on stigma. I want to read the high level bullet takeaway quote from it, where they wrote: “Since the emergence of COVID-19, we have seen instances of public stigmatization amongst specific populations and the rise of harmful stereotypes.” At the time when we first identified the SARS-CoV-2, when the majority of the cases were in China, there was the rise of anti-Asian discrimination. We've kind of seen that throughout the pandemic in a variety of ways. Could you talk a little bit about how we should be thinking about this and combating discrimination tied to whole swaths of cultures and races and countries?
HF: The history of disease and pandemics is filled with the idea of blaming the other, or someone else. You can go back to the early 19th century and the names for syphilis. The English called it the French disease, the French called it the German disease. I'm not sure who the Germans attributed it to, but it was always some other. That was the source, the origin, the responsible party for the disease that is now afflicting us.
In the case of naming of diseases, one of the steps that the World Health Organization has taken is to do away with naming according to the place where a particular organism is first detected. The 1918-1919 influenza is popularly known as the Spanish flu. It didn't start in Spain. It was actually first reported in Spain by the news media because Spain was neutral in World War One and the combatant countries were suppressing any press reports of information that could give comfort to the enemy. And so, the outbreaks of these diseases on other parts of the European continent were never reported. It was reported in Spain and that became the name. So not only are the epithets and characterizations and attributions about places or peoples misplaced, misguided, and misleading, but history teaches that they're often just totally erroneous.
I guess human instinct is always to look to blame someone else for our troubles. In the case of infections, yes, it's true they all start somewhere. But occasionally they start in ways that are indiscernible exactly where and when it was originally. It is important from the point of view of epidemiology and virology in terms of tracking and especially being able to predict future outbreaks and to control them, to work on assessing, analyzing, tracing back, understanding the origins of place and circumstance. But that shouldn't extend to the idea of naming and blaming so that it excuses anything that we do, because it's really someone else's fault that we are suffering from this condition.
You may know the Chinese have a rumor going around this was an American disease planted in China, because of the emnity from the administration to the Chinese. So it's not exclusively an American flaw to blame others, but it is a human tendency that is best resisted when we’re trying to deal honestly and effectively with something as serious as COVID-19.
KU: We actually haven't really talked much about emergency use authorization, which that the FDA uses when we don't have a full wealth of data and tests and clinical trials that we typically would for a treatment or a drug. Hydroxychloroquine was one of the earlier ones in the COVID-19 pandemic, later retracted. And there have been many others. So could you talk a little bit about this tool that the FDA has and those risks and benefits? Is this going to be a new way of doing business for us?
HF: The US Food and Drug Administration, the FDA, really has set the world standard for careful and effective review of new medications, new drugs, and new devices that could be applied to treat patients. The FDA standards for a proven drug or a vaccine or a device are very rigorous. They require extensive documentation from the manufacturer, and from independent parties about the, the effectiveness and safety of the proposed drug. They require comparisons against placebos, meaning an agent that is believed to have no effect, from the treating clinician and the recipient doesn't know whether they've gotten the real drug being tested or the placebo. And the reason placebo control is so important is anytime you receive anything that you believe could help you, for example, you can have an effect. You want to make sure that there's a genuine physiological, biochemical, or metabolic benefit from the agent.
Now, these rigorous standards for approval have limitations, especially when you may have a condition that is relatively rare, extremely serious, or life threatening and where there could be an experimental agent that is available to treat it. And so the FDA has an option that it calls compassionate use, which can authorize individual one-off use. And then this intermediate level of authorization called emergency use authorization, or EUA, was put in place about a decade ago to provide a capacity for the FDA to say well, there's enough promise and enough need that we're going to authorize this agent’s use under these emergency circumstances even though it has not yet met the full requirements for approval.
If you talk to any of the FDA experts, they're very careful not to use the word approval when they talk about these EUA agents, because they want to differentiate the full approval from the emergency use authorization. That'll be very clear. Even when a vaccine has received full approval, that is no guarantee that it will work in every patient, nor is there any guarantee that in time there might not be new evidence that would question the wisdom of the initial approval or emergency use authorization.
When the standard for allowing the use authorization is even lower, this means that it's available to us and the evidence looks promising. At the same time, it has not met the rigorous standards for full approval. Both of our vaccines are under emergency use authorization. The monoclonal antibodies that are being deployed are under emergency use authorization. And it is true that at one time, hydroxychloroquine was an agent that was under EUA and has since been withdrawn. That's a very interesting example, because it clearly was clouded by politics, a repeated boosting of this agent, which was not without reason. I mean, there were laboratory indications that hydroxychloroquine along with many, many others drugs [might have helped]. The question is always: Do we have anything off the shelf that could be effective against this virus? It would be a fantastic advantage. Hydroxychloroquine, a treatment for malaria, did show some action in vitro, in the laboratory. But we know from many, many experiences that that is no assurance about what will actually happen in a patient who is infected and then treated with this agent.
The only way to learn is to actually do the trials. And when you have politicization of the advantages of this untested agent, where we have the clinical and scientific experts constantly telling us, it needs to be tested, it needs to be tested, and political figures constantly telling us, it's going to be a miracle, it's going to save everybody...that created a lot of tension and pressure. And I suspect in the fullness of time as this story of the COVID response plays out, this set of actions of the FDA is not going to be its credit over time on the hydroxychloroquine decision making. But it has been withdrawn and every clinical trial that has been reported has demonstrated that that particular treatment is not effective. And it's a lesson that in medical science, you look for those that are promising and then you do the clinical trials. If you don't do the clinical trials, you simply cannot know whether or not this agent holds any value in the treatment of the patient.
KU: What's your take on the role of telemedicine, which has seen a big increase? Is that going to be something that's lasting?
HF: That's a fascinating question. One of the effects of response to COVID, including the use of Zoom, like we're meeting with right now, or in medical care, the growing prominence of telemedicine. Many of these experiences that we were forced to try because we could not gather in the usual traditional ways are going very likely to have a lasting impact on the conduct of our lives, whether it's the amount of travel arrangements or the ways in which museums of science are going to be responding to the future interests and needs of the public, or the way in which medical care is practiced and especially the role of telemedicine. These are going to play out in various ways in the future.
Telemedicine is one area that has many advantages in principle. I can remember the days when it started out as literally telephone medicine, where you have a telephone consultation. And now, with the advent of our ability to be able to see one another and examine with a camera - what does that rash look like, what does the patient look like? That gives a level of advantage of opportunity in clinical care that really offers tremendous gains of efficiency. It saves the patient travel. It makes the use of professional and nursing and physician time much more efficient. It can accomplish many things successfully. And we are very likely to see a greater continued reliance on this form of medical consultation going forward, along with other impacts on medicine and public health surely as we go forward. Telemedicine is a really good example of the forced experiment under COVID that's likely to have lasting effect in the way we live our lives.
KU: What’s something we haven't talked about that is potentially a major change to our scientific medical public health system that you think is going to maybe be a lasting change for us?
HF: From the point of view of conduct of science, I think another two influences of COVID are, first, demonstrating the importance of fundamental research basic research. The idea that a vaccine could be developed in the space of a year actually rests on a very deep wealth of prior research, understanding the basics of biology, of immunology, of RNA technology that has enabled the applied development in a very short time.
And the second is a big boost to open science and collaboration as a mechanism to more rapidly advance when there is a defined objective that needs to be met in science. And so, the practice of science, I think, is going to be also influenced in an ongoing way, just as so many aspects and how we live our lives, the way we relate to one another, the disparities in our society. The telemedicine example that you cited. All of these are going to be affected, and some more profoundly.
The Institute for Science & Policy is committed to publishing diverse perspectives in order to advance civil discourse and productive dialogue. Views expressed by contributors do not necessarily reflect those of the Institute, the Denver Museum of Nature & Science, or its affiliates.