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>> Howard Bauchner: Hello and welcome to Conversations with Dr. Bauchner. Once again it is Dr. Bauchner, Howard Bauchner Editor in Chief of JAMA. And I'm joined by two remarkably, remarkably distinguished individuals. One is a good friend who I've known for many years. He's our legal correspondent and knows an incredible amount about the legal issues involving health as well as ethics, its Larry Gostin. He's a university professor; Georgetown University's highest academic rank confirmed by the University Professor, he's the founding Linda D. and Timothy O'Neal Professor of Global Health Law. Welcome Larry.
>> Lawrence Gostin: Thanks Howard. It's really great to be with you.
>> Howard Bauchner: And he's joined by Michelle Williams. Michelle is Dean of the faculty at Harvard TH Chan School of Public Health. The Anglo Pullis Professor in Public Health and International Development; how'd I do with that one Michelle? I'm not so good on those names sometimes?
>> Michelle Williams: You did well Howard.
>> Howard Bauchner: International development HT Chan School of Public Health, internationally acclaimed epidemiologist and public health. She's been dean for the last four years. We're going to talk about what will evolve into one of the greatest challenges in the history of public health in the United States, which is the lawful and ethical prioritization and distribution of vaccines with respect to racial minorities for the Covid 19 vaccines. Larry and Michelle have written a viewpoint that we're publishing simultaneously with Harold Schmidt and it is entitled, is it Lawful and Ethical to Prioritize Racial Minorities for Covid 19 Vaccines? We're going to start with what was the recently released National Academy of Medicines framework for the distribution and then we're going to talk about the content of the viewpoint. And I've already discussed with Larry and Michelle that - that Larry will outline the proposed framework from the National academy of Medicine. Larry?
>> Lawrence Gostin: Thanks Howard and let me just begin by saying you know we've been friends for so many years. And friend of JAMA, it's just really - it's wonderful to be with you. The - our viewpoint really begins with the idea that - that of racial minorities, Black Americans, Latin-X, indigenous communities have disproportionately been burdened by Covid 19 and also have a long history of unequal health outcomes. The National Academies of Science Engineering and Medicine has recommended prioritization of racial minorities who are worse off socioeconomically and epidemiologically. And the WHO, World Health Organization also cautioned that if we just did color blind allocation frameworks we could perpetuate and exacerbate racial injustice in the United States, particularly in relation to health. And so the question for us, for Michelle and Harold Schmidt in this viewpoint was really what is the ethical case for prior - prioritization of racial minorities per vaccines and what would be lawful and constitutional? And we started of course, with the National Academies framework. The academy allocates vaccine in four sequential phases with distinct priority populations. And within each population group vaccine access would be prioritized for geographic area identified as vulnerable by statistical measure called social vulnerability - the social vulnerability index. That index has as one of its factors of - racial classifications. That is to give some priority to race. But as Howard, Michelle and I were talking about before we even came onto this view, the - the National Academies are making recommendations to the CDC's advisor committee [inaudible] immunization practices, but ultimately the decisions about the actual allocation of these vaccines will end up with state and local health departments and a lot will depend upon how they allocate them. And of course the most important thing is we don't want a free for all based upon wealth or power or influence. We don't want states to be bidding against one another as they did with personal protective equipment and other things in the early stages of Covid. But what we want is an ethical, legal practice so that we - we can insure that the most vulnerable among us and those who have been subjected to such great disadvantage not only with Covid 19 but before that that they have a fair shot, equitable shot of for future - that's healthy. And that's the importance I think of this problem. That's what Michelle and I have tried to contribute to and now I'll just turn it over to you Howard and we can begin a conversation.
>> Howard Bauchner: Yeah, we'll return to certain issues because I think in the viewpoint you - you emphasize that a distribution based upon race alone could eventually make it to the Supreme Court and be found unconstitutional and that's to be avoided. So - so we'll return to that and I just want to mention that both for the National Academy of Medicine and the Advisory Committee on Immunization practices you're likely to prioritize at least initially the 20 million or so estimated healthcare workers. And then after that it will be essential workers and then at risk populations. And then there's prioritization within each of those groups. Michelle the second section of the viewpoint is entitled Covid 19 communities of color. It's been a very painful year for the United States and particularly for Black Americans and Latin-X and other groups. How do you think about this vis e vis vaccines?
>> Michelle Williams: Yeah, no thank you Howard. You know just to add the motivation here is to really not go back to that painful space where we were as we were appreciating just how widespread and disproportionately spreading the virus was. So it was painful because we saw an unfolding of the pandemic and then we saw the murder of George Floyd.
>> Howard Bauchner: Right.
>> Michelle Williams: And that brought into stark relief for all of us a real awareness and the awakening and reckoning of the basic inequalities that exist in our society. And it was playing out during the time of a pandemic. So health disparities and access to quality healthcare, access to testing the disproportionate burden of infection - infection rate but also death rates contributed to Covid came into very painful stark relief. I will tell you that we were motivated in having a real discussion in the middle of our viewpoint here about the source - the social justice rationale for the framework that we you know, that - that we wrote about. Because you had to think about as the pandemic unfolded we saw that lower income individuals, largely Black, Latin-X and native individuals were less likely to have access to testing. While they were more likely to be in occupations where the feasibility of doing the public health intervention of working remotely was not available to them. They were living in dense housing situations with multiple generations in a household. So higher risk, older individuals were particularly at high risk in the Black and Brown communities. They - the fundamental structural inequalities that existed pre-Covid just became just that much more visible and stark for us to appreciate. And when we think about what happens in allocating a vaccine, we realize that race based allocation model would be fraught because of the legal issues that Larry discussed. And there are social vulnerability index that race is an embedded variable within the context of other geographic income employment population density variables that give us opportunity to have equity as a cross cutting consideration in how we allocate the vaccine, making sure the vulnerable and the high risk have access without a running up against legal and ethical issues.
>> Howard Bauchner: Larry what would be the legal challenges? I mean you talk about it in a viewpoint. I know this is your area of expertise. What - what are the potential legal challenges?
>> Lawrence Gostin: Yeah well we have to see this also in the context of the current confirmation hearings of Amy Coney Barrett. Because the - the judicial composition of the Supreme Court is going to change. Already there was a probably a majority of five to four majority before Ruth Ginsburg died in favor what - what the court calls strict scrutiny of any prioritization whether it be in educational benefits or in this case health or vaccine benefits. And strict scrutiny means - usually it means that we can't do it. Chief Justice Roberts famously said if you don't want to discriminate against race then don't discriminate against race. And that's you know, could be a dagger to the whole idea of affirmative action and trying to remedy past forms of discrimination. And so what the current changing - changing composition of the court we thought that the last thing we wanted to do was to see something so sensitive, something so important to health of the American population as you said earlier Howard. This is the most important allocation of a medical resource that I can remember in my lifetime. We don't want it - implementation stole or - or controversial as it winds its way up to the courts, and the Supreme Court and so what Michelle, Harold and I tried to do is find a way to actually defacto give preference to racial minorities. But based upon you know clear disadvantage, clear social and economic disadvantage. And that was the - that was the way that we were really nudging the CDC, ACEP and the National Academies to do so. They can accomplish the same goal, but do it without really just feeding into the cultural controversies that are going on in our country today.
>> Howard Bauchner: Michelle do you think - do you think the social index goes far enough? Do you think it gets us to immunization of those groups that have been so disadvantaged for such a long period of time? I mean we're all a little older. Healthcare disparities have been with us for many, many decades. That is not the new issue. They were unmasked in - kind of a painful way obviously. And then as you already mentioned combined with the killings of various black individuals men and women. Do you think the social index goes far enough in making sure that those groups appropriately get access to vaccines?
>> Michelle Williams: It's a great question and I will you that in our viewpoint we indicated that we should model and communicate how it goes, so that we can empirically answer your question. But I - I think from this perspective we - we will have to do something. And the social vulnerability index, you know there's precedent for it. It was developed for us to be able to be prepared in response with you know, prepared to respond to natural disasters that would hit vulnerable communicates. And so it is a good place to start, given the legal context that we have that you heard Larry just talk about. It could probably go farther, but we will have to do the modeling in communities, in states across this nation to really identify just how far and just how consistent it - it will capture the low income black and brown and Native American populations that are vulnerable to this pandemic. And you know, should have reasonable access to a vaccine that is healthy, that is safe and effective.
>> Howard Bauchner: The good news is there's enough data to actually do the modeling. The data exists, so it's not like it's going to be theoretical and you know, have a lot of disagreements over the models. We haven't published any modeling papers over the pandemic. I'm happy because I think all of them were wrong in different ways because it evolved so quickly. Larry, what's the fine line? The legal fine line?
>> Lawrence Gostin: Let me begin by saying that if it were me, and - and I were on the court I would be much more partial to - to explicit racial preferences.
>> Howard Bauchner: Okay.
>> Lawrence Gostin: I do believe in affirmative action and I think - you know our viewpoint Howard as you know, we - you know we make the ethical case that - that structural racism does justify race based classifications. But for the court, and that's - goes exactly to the, to your question Howard, for the court anything that has a specific class - race preference, that is once you actually single out ways as one factor or even one of many factors, you could get strict scrutiny. So if you - you might want to call just by analogy the affirmative action cases that came before the court in relation to admission to universities. That was very, very controversial. The court said if race was just one of many characteristics that it could - it could accept it. But the court's shifting. It's been shifting very quickly even before this new confirmation that we expect. And so I think that any explicit class based upon race, even if it's diluted with many other factors could find its way to the courts. And at the moment the Supreme Court has been quite hostile to the idea of any race based classification at all.
>> Howard Bauchner: If a vaccine gets approved in the first quarter of next year, let's say January, February and they announce that 50 million doses will be available, let's set aside how will they be distributed? How will they be allocated within the States? The general sense will go to healthcare workers first. Now the good news is hospitals generally are pretty good about storing vaccines and giving them. Once we go beyond healthcare workers we have an entirely different set of challenges just logistical challenges. Could the Supreme Court get tested quickly? I mean usually I have a sense of it takes months or years, but could it move up to the Supreme Court by February or March? Is that actually even possible Larry?
>> Lawrence Gostin: It's unlikely.
>> Howard Bauchner: Okay.
>> Lawrence Gostin: It's unlikely but it's - it is possible. Normally the court won't take a case unless it's been well vetted in the lower courts and even then it requires two circuit court of appeals to be in conflict as there are many of the - the Affordable Care Act and other kind of cases or just those kind of cases that the courts dealt with. But - but we're in uncharted territory and - and already the Supreme Court has made two decisions relating to Covid 19. And they both had to do with religion, the Freedom of Religion. Frankly with the 6-3 majority that case probably would have gone the other way because now Chief Justice Roberts is the swing vote in a - in closely contested really socially raw cases. He won't be anymore most likely; I'm just assuming that Judge Coney Barrett will be confirmed. She's very well qualified. And so the - it could go up very quickly and if it did I couldn't - I couldn't say with a great deal of assurance that they wouldn't either strike it down or send it back down to the courts with clear instructions which delays and the - as we say it delays one of the most important public health implementations that we see in our lifetimes.
>> Howard Bauchner: Now Michelle it's interesting, in the - in the viewpoint you talk about a different scale and - and I was struck that you said that - that they are different. The other one that you talk about is the area deprivation index, the ADI. You don't have to go into great details, but how is that different than the one that the National Academy of Medicine mentioned. Because I know in the viewpoint the three of you talk about it, you talk about that - that being more comprehensive and trying to identify individuals who are disadvantaged. And that it - it speaks less specifically to race. Could you just talk about these different scales?
>> Michelle Williams: Right so the area deprivation index actually integrate it's a number of variables. It integrates income, education, employment and housing quality in deriving a vulnerability. And so it - it does not explicitly use race. But these variables are intertwined with race and ethnicity. And so you can get at the level of vulnerability I think without explicitly invoking race. The social vulnerability index which was developed specifically for public health emergencies, for identifying vulnerable populations in the face of natural disasters, hurricanes, earthquakes is based on 15 different variables. And race is among those 15 variables. But it's only one of them. And so it has allowed local regional and national planners to allocated preparedness and response resources based on population vulnerability that includes race, but not explicitly or exclusively due to race and ethnicity alone.
>> Howard Bauchner: Michelle how -what's your sense, so you know you're Dean at the Harvard School of Public Health, Harvard Chan School of Public Health. Sandra Galeo who writes for us is at BU. [inaudible] former faculty member for you is at Tufts. So the governor is going to call the three of you up. And he's going to say "We have 10 million doses for the commonwealth of Massachusetts." What do you do next? Let's take the healthcare workers off the table. That a million doses went to healthcare workers. You have nine million doses left to distribute. And he calls up the three deans of the schools of public health and says "Help me"; what's your sense of what you would do next Michelle?
>> Michelle Williams: You know - my guiding principle would be that equity is a cross getting really central to the decision making, the distribution of the vaccine. I would definitely say if we've got healthcare workers covered then we really have to think about essential workers and we have to do that through the - and vulnerable elderly population, particularly those living in crowded settings and in - in high - with high risk medical conditions. But all of that has to be under guarded with a strong commitment where equity is core at the consideration.
>> Howard Bauchner: Larry can this - can this vary a great deal from state to state? You know we talked earlier. It is confusing, you know McKesson is going to get 100 million doses and they'll distribute it to the 50 states, Puerto Rico, District of Columbia. You know it was a nightmare with Rendisivir. I remember one critical care doc saying we just got 100 doses, I have no idea why we got 100 doses, we have no cases. And while Michigan got no - they didn't get enough Rendisivir and they had cases. I mean let - assuming we're a little smarter at it this time. Could what the Commonwealth of Massachusetts do be very different than what Alabama does.
>> Lawrence Gostin: Yeah I think it - I think it will obviously because no matter what - no matter what framework is used Howard it's absolutely going to be up to state and local health departments and ultimately to state governors and legislators to make the decision about how exactly things are going to be implemented. This is also another you know, legal and - legal question as well as a policy and public health question behind we're a federalist society. The Centers for disease Control and Prevention don't have any power to force states to do anything, to give them the resources. But then he can't go in and micro manage what exactly they're - how they're allocating. I mean it's very possible that you could have a highly conservative say southern state. That might make very, very different choices then the state like you know, Massachusetts or New York or Maryland or - or the District of Columbia. So yes, you're going to get really, really different outcomes and that's you know, federalism is a - has been a conundrum with Covid 19 because it's supposed to work well by giving states kind of you know, they're closer to the people, they're more innovative. But in the end it hasn't been uniform. There hasn't been a national plan and that's been a problem. So I hope that problem won't continue.
>> Howard Bauchner: Yeah, you know I've had a lot of discussions with the advisory committee on immunization practices. Just to try to understand it is just an advisory committee. It's very striking. I mean I'm a pediatrician so we follow what the American Academy of Pediatrics says, all the time. But the ACEP is an advisory body, it has no legal standing at the state level. Do - do you two fear that money will win out? I always feel like - I mean I'm amazed who was able o get tested. I'm still amazed that like the hockey league, the NFL, the NBA they seem to have as many tests as they want. I'm amazed. Do you fear that money will win out in the end, you know of the available 10 million doses? Really well off people will just pay for them and get it.
>> Lawrence Gostin: Michelle and I are clamoring for this. You can have the first go Michelle.
>> Michelle Williams: So absolutely. I mean I think one of the most disheartening things that you know, at the outset of this was the access to testing really depended on whether you had resources or you were a celebrity. And the people who needed testing the most were you know essentially an afterthought. The essential workers who you know, who had high risks commuting to their work, high risks at their work, high risks in their multi-generational households were often an afterthought in - in the standing up and allocating testing resources to the population. When you think about Navajo Nation was one of the last places that we really mobilized resources to get testing done. So you know I'm - I'm passionate about not repeating you know, this inequity and access for the vaccine, which you know is going to be the single most important public health response to this crisis in - in 100 years. That we not make it be so blatantly you know personality and money oriented for getting in the front of the line.
>> Lawrence Gostin: Yeah Howard would you mind if I jumped in here?
>> Howard Bauchner: No it's meant to be a conversation.
>> Lawrence Gostin: I - obviously I totally agree with Michelle. I think this is what's going to happen. It won't be the - the same kind of you know, raw inequity and free for all based upon money, power, influence that we saw with testing and personal protective equipment and things like that. Because I think we will have a national plan, we will have national priorities and that's good. So I think it will take the edge off of the - the raw power based, money based competition. But I can't imagine that having considerable wealth, access to concierge or - or well-paid physicians and also power, including political power and - and celebrity fame won't push you closer to the top of the queue. It's very hard for me to see that - the case -if you think back to the H1N1 vaccine. This is now taking it globally. There were pre-agreed with WHO distributions based upon and more equitable formula for lower income countries. But once the epidemic hit, everybody pulled out all the high income countries, including President Obama and it was only when we had enough vaccine that was then distributed. And I think we're going to see not as raw as - as before, but we are going to see class - class and power and money, race preferences. It's hard for me to think otherwise.
>> Howard Bauchner: Michelle -
>> Michelle Williams: Howard if I may, there's one other consideration and that is the infrastructure available for distributing this [inaudible] the vaccine is going to be important. And so you know when we talk about communities, when we talk about states, it's going to in large part be - how ready are the systems, the public health systems, the healthcare delivery system to manage implementing the distribution of the vaccine. And that's something I worry about as a public health person where there's been you know, prolonged [inaudible] investment in our infrastructure.
>> Lawrence Gostin: Yeah and of course you've got - getting it to kind of poor rural communities, inner-city communities, things like that. I think that the - the less prepared we are in terms of vaccine and healthcare infrastructure, the more we're going to see discrimination against the poor because those are the ones that often have the most difficulty getting access to medical resources.
>> Howard Bauchner: As I said, the first 20 million doses go to healthcare workers; the good news is that they're largely hospital based. And hospitals will be generally good at storage and distribution. I thought there's 10,000 community health centers in this country and they really do serve a very specific population described in these social indexes. And I was hoping that we could sort out a way to make sure they know how to store and distribute vaccine. Because then I feel like they're connected to the community that - that we would like to focus on and so I'm hoping the - that each state will be able to invest in those community health centers that they know serve the group of people that these indexes are going to model and say should be a priority. And many of the people who are essential workers probably get care at those community health centers. I know I'm biased, I'm thinking of Boston, East Boston, Dorchester House, where I know -
>> Michelle Williams: Chelsea -
>> Howard Bauchner: Chelsea, there - those are the - those are the places that would be able to reach the individuals. One - two questions have come in; it's the same question Michelle. I feel like I have to ask you, you're African American, the issues of vaccines in the African American community. How - how do we get there? How - how can we try to get to more trust around this issue?
>> Michelle Williams: That's a great question. You know we've got to - we've got to work on this. And I think it begins with acknowledging and reckoning with our history that really contributed to an erosion of trust. This is not the first time that the African American population has been skeptical in the face of public health crises. We have to really get to a place where we reckon with the past wrongs. And we effectively communicate to this community. It means investing in holding intimate conversations in communities around what we - where we've gone wrong and why we have to move past let's say Tuskegee and think seriously about how African Americans engage in - in participating in clinical trials. The efficacy and safety of the vaccines will only be generalizable to those populations who participate in the trials or where we can accrue the - the experience and the understanding of safety and efficacy. So there has to be clear conversations reckoning with the past and then an acknowledgement of the scientific process that involves recruitment of a diverse population of individuals by geography, race, ethnicity, age in these clinical trials so that when we are out of a phase III clinical trial we know the populations to which the inferences about safety and efficacy can make - be made. We have to go upstream Howard, honestly. We can't just go to a black and brown communities and say "Sign up for clinical trials, participate in clinical trials," if there is not deep representation upstream in the science and the management of the processes that bring about the science. So it means really finally reckoning with the systematic racism, the history of where black and brown people have been misserved, excluded from the research process, excluded from the - the data that brings forth information about safety of therapeutics and vaccines. And then a real effort as we discussed to make sure that we don't do anything in the allocation of safe and effective vaccines that would exacerbate disparities.
>> Howard Bauchner: Larry final word?
>> Lawrence Gostin: Yeah I mean Michelle said it so eloquently. You know we have - I was going to say deficit of trust in the United States, but it's really a cavernous distrust and a huge gap and we are going to need to do a lot as a scientific medical public health community to actually work together to make sure as - as Michelle said both upstream and downstream. I think we're going to need to go into communities, have community leaders lead vaccine - vaccine trust and trusting public health. But we're also going to need government to actually go back to the - the way that - the data that we got the research we've got and really kind of make up for you know, a long history where - where we - where frankly public health deserves that distrust unless we earn it back. And we need to start earning it back soon and urgently.
>> Howard Bauchner: This is Howard Bauchner, Editor in Chief of JAMA. This has been Conversations with Dr. Bauchner. What a pleasure to talk with Larry Gostin. Larry is our legal correspondent, he's a university professor at Georgetown - Georgetown University's highest academic rank. And Michelle Williams, Michelle is Dean of the Faculty at Harvard TH Chan School of Public Health internationally recognized epidemiologist. We've been talking about an incredibly important viewpoint. Is it lawful and ethical to prioritize racial minorities for Covid 19 vaccines? Harold Schmidt is the first author and Larry and Michelle are his two co-authors. Larry and Michelle thanks so much for joining me this day - today and please stay healthy.
>> Lawrence Gostin: Thanks Howard.
>> Michelle Williams: Take care.