It’s been a while since we’ve done a Covid/bioethics podcast (see prior ethics podcasts here, here, here, and here). But Covid is not over and this pandemic keeps raising challenging issues that force us to consider competing ethical considerations.
This week, we discuss an article by bioethicists Govind Persad and Emily Largent arguing that the NIH guidance for allocation of Paxlovid during conditions of scarcity. They argue that the current guidelines, which prioritize immunocompromised people and unvaccinated older people on the same level, should be re-done to prioritize the immunocompromised first, and additionally move up older vaccinated individuals or vaccinated persons with comorbidities. The basis of their argument is the ethical notion of “reciprocity” – people who are vaccinated have done something to protect the public health, and we owe them something for taking that action. Eric and I attempt to poke holes in their arguments, resulting in a spirited discussion.
To be sure, Paxlovid is no longer as scarce as it was a few months back. But the argument is important because, as we’ve seen, new treatments are almost always scarce at the start. Evusheld is the latest case in point.
Sometimes, you can’t always get what you want…
Eric: Welcome to the GeriPal Podcast. This is Eric Widera.
Alex: This is Alex Smith.
Eric: And Alex, who do we have on the show with us today?
Alex: Today, we are delighted to welcome two bioethicists. First we have Emily Largent who is a bioethicist in the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine, welcome to the GeriPal podcast, Emily.
Emily: Great to be here.
Alex: And we have Govind Persad, who is a bio ethicist at the University of Denver Sturm College of Law. Welcome to the GeriPal podcast, Govind.
Govind: Thanks, Alex. Thanks, Eric.
Eric: So we have a hot topic today. We’re going to be talking about whether or not we should prioritize the vaccinated over the UN vaccinated. As we think about COVID treatments, scarce resources, maybe even COVID prevention got a lot to discuss today. And this stems from a Gem Health form viewpoint that Govind and Emily wrote titled COVID 19 Vaccine Refusal and Fair Allocation of Scarce Medical Resources that we’ll have a link to on our podcast. But before we start on this hot topic, Emily, I think you got a song request.
Emily: I do. I requested The Rolling Stones, You Can’t Always Get What You Want.
Alex: Love this. I guess it’s pretty self-evident why you chose this one.
Emily: It is. Although I feel like the next part, right? But you can get what you need is not maybe accurate circumstance.
Alex: Yeah, it’s true. Okay. Here we go.
Eric: Lovely, Alex. So let’s dive into this topic. So it’s been a while since we’ve done a COVID podcast and especially a while since we’ve done one on ethics in COVID. We’ve previously had one at the start of the COVID pandemic talking about scarce medical resources, how to allocate them, we’d had folks like Doug white on, but something’s different now. So we’ve had vaccines, we’ve had a lot of changes as far as therapeutics and recently I’ve seen a lot of op-eds especially September, November, December around should we prioritize those who are vaccinated over the unvaccinated around scarce resources?
Eric: I’m wondering, maybe I can turn to both Emily and Govind, whoever would be willing to chat, how did you decide to write about this or think about it from an ethical perspective?
Govind: Sure. Yeah. So I think a few different things from my perspective, and I’m sure Emily may have her own. So one was that especially as these new antiviral drugs like Paxlovid and Molnupiravir looked like they were starting to become available, there was actually getting to be a question about whether unvaccinated people would be prioritized over vaccinated people for access to some of these therapies. And I think that sort of raised new questions about whether people… There were sort of anecdotal reports of people saying, “Well, maybe I won’t get vaccinated because I can get an antiviral instead if I get sick.” And at that point as opposed to now, it was still quite short supply of these antivirals. I think it still was globally, but in the US less so now. So that was a big sort of fact than motivated.
Govind: The other thing for me, and I think Emily may have more virtuous motivations is I just thought a lot of the arguments that people were making in op-eds or on Twitter were just really not good arguments and often take this form that I always find is frustrating as an ethicist, where people would instead of engaging the merits of what are the pros and cons of considering vaccination status, they would be like, “Oh, you can’t do that. It’s gross. It’s shaming on vaccinated people. You can’t even talk about this. People who want to talk about considering vaccination status are disgusting.”
Govind: And this I think is not necessarily a prudent way of writing, but I felt like, “Gosh, these arguments are just not very good.” Regardless of how you come out, it’s useful to have a treatment that takes this issue seriously and tries to engage with what the arguments are for and against as opposed to just yelling at people to shut the conversation down, and so I think that was part of my motivation for thinking about the topic.
Emily: Yeah. I’d actually echo that. I think that for me, it seems like an argument of extremes where people definitely wanted to consider it, oftentimes I think because they were angry that people weren’t being vaccinated and then wanted access to resources. And then on the other hand, there were people who were very much like you can never consider it, and it seemed to me that it was much more nuanced than that and it was nice to have a chance to sit with Govind and think through what is that nuanced position?
Eric: And especially around, I guess, what the default is right now, there is COVID 19 treatment guidelines, I think, published in the NIH about prioritization of therapeutics and there is a framework currently out there, is that right?
Govind: Yeah, there is. We’re pretty critical of their framework in our piece, but yeah, that is the framework that’s out there now. Interestingly, it wasn’t clear to us in reading it that there are people of the NIH who we were both fellows, not in the part of the drafts COVID treatment guidelines way back when it wasn’t super clear to me that there were people who had expertise distinctively in ethics who drafted those guidelines as opposed to people who were more experts in clinical management. And on the prioritization front, I think we ended up being pretty skeptical.
Govind: It’s not clear to me actually, totally, and I’d be really interested, Eric and Alex, for your perspective as clinicians. Given that we’ve been told that we shouldn’t be treating Paxlovid and certainly Molnupiravir is scarce now, whether those guidelines are still being used as gatekeepers. But yeah, there are those guidelines even though we thought that they had issues even when they came out and it’s not clear whether they should be still used as reasons to say no to somebody now.
Eric: And just to let people of our audience know, we’ll have a link to this, but there’re kind of four different tiers. The first tier is really focused on immunocompromised individuals were thought not to amount a response, and also unvaccinated individuals at the highest risk of the disease, that’s tier one. And then tier two is unvaccinated individuals not included in tier one who are at risk for severe disease.
Eric: And then at tier three, we start getting into vaccinated individuals at high risk for severe disease, and then tier four, again, vaccinated individuals at risk for severe disease at a little bit more detail. So in that framework, it really does prioritize immunocompromised and the unvaccinated. What’s wrong with that? Why not prioritize them?
Emily: Well, I’ll actually just start by not quite answering your question but saying what I think is a really important piece of all of this, which this is really about prioritization in times of scarcity. So I think that so often where these conversations in my opinion went wrong is that they said, well, doctors shouldn’t discriminate on the basis of vaccine status, they should always give people what they need.
Emily: And these are circumstances where we go back to the song that we started with, you don’t have enough to give to everybody, so you can’t always give everyone what they need, you have to make some tough choices. And so this is really the context in which we started thinking about this, where if there was enough for everybody, then it makes sense that everybody should get what they need, but these are real circumstances of scarcity that we’re focused on.
Govind: Yeah. I mean, beyond that, I think Emily’s done a really nice job of framing the problem that I think is useful in answering the question. Our view on the NIH guidelines isn’t so much that it’s sort of never appropriate to consider vaccination status, including the unvaccinated if it raises your risk of harm from COVID 19, but we thought that the way that it did it seemed sort of somewhat ad hoc and even from a purely… So we talk about different values in the piece. We talk about value of preventing harm, we talk about the value of reciprocity and of addressing mitigating disparities.
Govind: But even if we just focus on the perspective of preventing harm, we weren’t worried about reciprocity or disparities, there are problems in the guidelines because I think looking at the post-Omicron, US actually makes this even clearer, there are lots of people who would be described as unvaccinated, we wouldn’t think are particularly high risk because they have recent prior infection and they’re still pretty young, and there are other people say, people who are vaccinated but unboosted who are older adults or people who are immunocompromised or have other severe medical problems who actually are making up a decent proportion of deaths right now in sort of the post-Omicron US.
Govind: And so certainly, vaccination status matters. Vaccines are a big protective against harm, but there are circumstances where somebody who is unvaccinated will be at lower risk than somebody who’s immunocompromised yet they all get stuff together in tier one under extreme scarcity. And even when you go to the lower tiers, any unvaccinated person with a risk factor could include somebody with a prior infection of the way the NIH defines that the risk factors are very broad. And to have them come before, say a person who is in their 60s who is vaccinated, especially if not boosted might not even make sense from the perspective of harm prevention.
Eric: Mm-hmm. Now let’s talk about some of those words you mentioned before. Let’s break down the ethical analysis of this. One of the words you mentioned is reciprocity. What’s reciprocity?
Emily: So when we talk about it, we talk about it as looking backwards at things that people have done often to promote a public good or alleviate scarcity and recognizing that as part of the allocation framework. And we focus on vaccines, but one of the things that I think helps contextualize this conversation is that we’re not introducing a new concept. In fact, if you look at things like organ transplants, there’s often a boost given to people who have either been donors previously or in some countries who have indicated that they’re willing to be donors.
Emily: And so even in the pandemic, we’ve seen circumstances like this where hospitals wrote allocation policies that were going to give preference to frontline healthcare workers in hopes, right, that they would incentivize them to stay on the job knowing that they would be taken care of and because they had been working for the public good. And so that’s how we conceived reciprocity.
Eric: So I can understand the organ donor part, you’ve done something in the past. I can imagine though you’d probably want to weigh how big was the sacrifice, doing an organ donation is much bigger than me getting a shot in my arm. I’d also think, is it reciprocity if we prioritize frontline healthcare workers or is it like that instrumental value where actually, we don’t care what they did in the past, we care that they’re able to work in the future.
Govind: Yeah. So often reciprocity and instrumental value can be hard to tease apart because often something that promotes the one promotes the other. And we actually see that with considering vaccination status as well. Because you might consider it both to recognize that some people have taken steps, and in some cases for me, it was not a big sacrifice, it was great to get vaccinated. I was glad to be protected against harm. I am a professor, I work from home. If I was somebody where if I had had to miss work, if I was, say, the sole caregiver for kids and I had dealt with side effects, it might have been more of a sacrifice. So I think even there it’s important to consider. But in terms of the reciprocity and instrumental value, there could also be instrumental value in incentivizing more people to get vaccinated.
Govind: So you’re right that those often go together. I think we often said that we prioritize healthcare personnel on the basis of instrumental value because it seems less controversial. But if you look at the actual arguments, they often had sort of elements of reciprocity in them. It wasn’t just to get healthcare workers to stay on the job, it was to thank them or recognize their service. Another area where this came up that I think has to just be clearly reciprocity is that people who were volunteers or clinical trial participants were often prioritized to some extent for COVID 19 vaccines.
Govind: And there again, compared to certainly being a frontline health provider, many people who were in trials were there because they really wanted the vaccine, they didn’t necessarily perceive being in a trial as burdensome, but is still thought to be by a lot of people important to recognize their contribution by way of reciprocity. And that’s not so much an instrumental value argument because once they’ve been in the trial, unlike with your docs and nurses, it’s not to try to get them to be in future trials or something so much as it is to recognize that past contribution, so I think that’s another example.
Alex: I think building on this point here, there is a distinction between people who the public health rationale behind vaccines is the idea of getting toward herd immunity, right. But I think individuals who are vaccinated don’t choose to be vaccinated in order to protect other people primarily, they choose to be vaccinated to protect themselves.
Alex: So there is sort of a disconnect between the public health motivations behind mass vaccination campaigns, and the individual motivations of people who are becoming vaccinated. And is it possible we’re attributing too much to those individuals who are being vaccinated and saying they deserve something because of the steps that they’ve taken to protect the public health?
Govind: It’s an interesting question whether we think about it in terms of motivation or contribution. So go back to your trial participant, we don’t normally differentiate whether somebody with a trial participant out of who are unspoiled altruism from somebody who was a clinical trial participant because they really wanted to get early access to a vaccine or the trial was financially compensating, they were motivated by that incentive. So I think it’s challenging with motivations because I think the motivations that people had both were getting vaccinated or for doing things like clinical trial participation are still multifaceted, maybe more multifaceted than for say something like organ donation.
Govind: And so I agree that, I think, for a lot of people the motivation was purely to protect themselves. I think in other cases, if you look at surveys, the motivations can be more complex. There were community-minded motivations, there were motivations that were not having to do with health but having to do with, “So my kids won’t keep calling me and telling me I have to get vaccinated,” type motivations so.
Eric: But if we’re using organ donation example, there are really no physical benefits for the organ donor. You can argue that there are other potential benefits being an organ donor, being altruistic, but in Alex’s point, there are physical benefits from getting a vaccine if you believe that the vaccine works, which all the data points towards yes.
Alex: Yeah. Just establish that right now. Starting from a place of agreeing that vaccines are effective.
Eric: I’ll probably get some tweets about that…
Eric: … but shouldn’t there be a distinction between that?
Govind: Yeah. So I could see perhaps how somebody who not only contributes to the public good, but makes a major net sacrifice by doing that might warrant even more reciprocity. But the question I think for our purposes is whether there’s a difference between somebody who contributes to the public goods say by reducing scarcity, by being vaccinated and somebody who doesn’t, that’s sort of coming back to Emily’s point about scarcity, in scarcity, it’s that comparison that we’re concerned with.
Govind: There might be a further question about, say, if you had to prioritize your garden variety vaccinated person against, again, somebody who really made major sacrifices for the public good, that person might warrant even more reciprocity. But I’m not sure that shows that it’s not relevant even in the case here, the sacrifice was minor or even the person benefited and the public good benefited too.
Eric: And Emily, where does all of this fit into the resource allocation framework? Is this the first thing we look at, are they vaccinated or not?
Emily: Yeah. So we make some simplifying assumptions in the paper that we talk about and it’ll be interesting to hear Govind’s perspective. I think he and I maybe diverge slightly at this point, but the idea is that there are two core values that we need to think about. So one of them is addressing health disparities, right? We don’t want to exacerbate disparities by adopting reciprocity, and it’s important to maximize the benefits that we have in any sort of resource allocation policy. And so we establish those as the two core values of a pandemic response and allocation in conditions of scarcity.
Emily: And then say that we assume that reciprocity can be used, but it has to be consistent with both of those values, and it should be used as a tiebreaker, but as a simplifying assumption that of course leaves open the possibility that reciprocity could play a larger role in allocation frameworks, but we just start with defending that simpler position.
Govind: Yeah. One thing you all are familiar with and I think many who have written for journals are familiar with is you don’t only have to write something that you feel willing to have out there in the world, but you have to satisfy reviewers. And the easiest way of keeping the article within the very constrained word limits of the viewpoint while making the points we wanted to make was to make that simplifying assumption. I think there are a lot of examples where people at least tacitly are willing to accept a somewhat less good outcome from the perspective of say benefit in order to get a better reciprocity result and use that on the organ case I think sometimes. But in the paper, I think just to make it simpler, we say, well, at the very least it could be used as a tiebreaker.
Govind: And that’s actually the way that one of the papers about priority for trial participants suggested this earlier on in the pandemic is they said, I think this is Annette Rid who is a colleague of ours at the NIH. Their view was there can be priority for clinical trial participants, but what you would do is you would put them at the front of the line within their tier. So if you remember all these vaccine allocation plans where you had the first tier maybe for much older adults or people in long term care facilities or something, and then the second tier might have been people over 50 or people working in highly exposed jobs.
Govind: If you were in a trial, the view there was that doesn’t jump you, say, ahead of the long term care facility participants say if I had been in a trial, but it might move me to the front of my group. So I think that’s one way of trying to… It’s almost especially about sort of how you formalize or operationalize these values and I think that’s one way that it’s been done.
Alex: Mm-hmm. Can we stick with this point for a moment? I want to just take a step back and applaud you for incorporating both the sort of public health ethos we talked about in an early podcast with Doug White, that the values and priorities differ in public health emergency, in a pandemic emergency. And traditionally we thought of, well, the core value there and there is only one is do the most good for the most people. And I applaud you for incorporating this second important component which is to not worsen existing disparities.
Alex: And I think there’s been growing recognition throughout the course of this podcast on the importance of not worsening, not widening disparities by any ethical allocation framework. To that point, in your article, you note that vaccination rates among blacks and Latinx individuals have been higher than whites according to a Kaiser Family Health news report. And I looked up the report and they are slightly higher, which was news to me.
Alex: However, I did note that booster rates, and you had mentioned booster rates before, Govind, are lower among blacks and Latinx individuals compared to whites. Thoughts on that and sort of the differences there in overall vaccination rates versus booster rates and the potential for widening disparities if we allocate.
Emily: So I do think it gets a lot more complicated when we’re looking at a multiple shot series and when we start looking at boosters and we start talking about now second boosters for some individuals, and trying to figure out at what point you draw the line and say somebody is or isn’t vaccinated, I think that does complicate things somewhat in practice. One of the things we talk about is that you have to define disadvantage and realize that given persistent disparities and structural racism, that there can be a complex interplay and that people who might be in what we think of as disadvantaged populations, they might have higher vaccination rates, but they might also have a much higher burden of non-COVID related health disparities.
Emily: And so I think what we advocate for generally is to think about this is a social vulnerability index as being built in and that’s probably a much better way to address the disparities issue than to try to adjust for that status across the allocation framework in terms of health.
Alex: Mm-hmm. And I note that your proposal doesn’t specifically incorporate allocation based on booster status. It’s not a part of your framework, it’s not a part of NIH’s framework.
Govind: Yeah. I mean, actually it is part of the NIH’s framework a little bit, and that they say that within the same tier, you should prioritize people who are not boosted. And boosters just seem different for a couple of reasons. One is that, I just think the guidance around boosters has been so in a lot of ways, confusing for people much more so than get vaccinated. And then also if you got vaccinated later, for a period of time, you actually still had to wait to be booster eligible when we were writing this at least. The other is just if you look at the absolute risk production, you get some from boosters. But in terms of getting people’s probability especially for scarce resource needs down, the biggest contributor by far is going to be that initial vaccine series, and the boosters aren’t further beneficial.
Govind: But if you’re looking at what’s really making the big chunk of difference in terms of keeping hospitals from being overwhelmed, it would definitely be that initial series, I would say. But Emily’s other point is really important, I think, for us to remember and I feel like we haven’t talked about it yet, which is that we often talk, and I think I’ve made the mistake of talking this way sometimes, as if scarcity in the pandemic is just a matter of like there are a ton of COVID patients and it’s only COVID patients we’re worrying about, and they’re the ones who are competing for all the scarce resources.
Govind: And part of what motivated me as well, I think I should have said, is that especially when we were sort of revising this and thinking about Omicron is that there were non COVID patients throughout the pandemic but especially at surge periods who were repeatedly having procedures put off, maybe being harmed in other ways, there were some studies suggesting that when hospitals are in contingency cure, this exacerbates certain kinds of implicit biases and disparities.
Govind: So even if there’s some reason to worry about considering vaccination status, on the one hand, maybe disadvantage some unvaccinated COVID patients who might disproportionately suffer certain kinds of disadvantage, in scarcity you have to think, well, what’s the alternative? And if the alternative is that your non-COVID patients who show up are getting their procedures delayed or running into other problems, what we say in the piece is that there’s reason to worry, given that we know about the burden of heart attacks and car accidents even, other emergent conditions tracking disparity as well. Getting severe COVID or even getting severe COVID from being unvaccinated isn’t necessarily more correlated with being on the short end of disparities than showing up in the hospital for some other reasons.
Eric: So a lot of this depends on past choice, your choices in the past. If you decided to get vaccinated or not, and there’s a lot of choices that we could choose like, “Oh, you decided to go to a crowded bar and that’s how you got COVID, you’re not going to get this treatment.” “Oh, you decided that you would go on a trip to Arizona during one of those surges, you’re not going to get this treatment.” How important is past choice as we’re thinking about these decisions and why just focus on this one particular thing, vaccination status.
Emily: Yeah. So I think your question actually points to even why you’re concerned that you saw in a lot of the responses that Govind and I were reacting to, which is if we can think about vaccine status, next, we’re going to make room for say fat phobia or other sorts of behaviors and incorporating a lot of past choices into allocation frameworks that people, I think, rightly find kind of icky, to use a not technical term. And I think that while there is an understandable bias, there are two ways to think about this.
Emily: One is that it shouldn’t be the individual clinician who’s deciding, right. It’s really important that in a public health emergency, when we have scarcity, these are institutional policies or they are policies from bodies like the NIH, so that you’re not admitting room for the bedside clinician to make discriminatory choices based on how they perceive the appropriateness of past behavior and choices, right. There needs to be a policy people are referring to and hopefully that can be applied evenly.
Emily: The other thing is that there really are ways to, I think, draw principle distinctions between whether or not you went to a crowded bar and got COVID there, or whether or not you were vaccinated. So in particular, right, it’s easily verifiable with a vaccine card that somebody has been vaccinated, but it’s much harder to make any sort of principle judgment about the appropriateness of the bar attendance. Because it’s not verifiable, right, to the person at the bedside in the same way. Additionally, I thought it was important for us to point out that it needs to be something that’s widely accessible so you wouldn’t want to create some sort of backward looking criterion for allocation that was not readily available to the population.
Emily: So when we wrote this, right, we knew that vaccines had been freely available to individuals, what was it? More than a year at the time we were writing this so there had been a long stretch where people could engage in the behavior that we were looking to incentivize and we also felt like it was important that there was a direct link between the action, right, which was getting vaccinated and what we were interested in which was alleviating scarcity by avoiding severe disease and death that would use up those resources.
Emily: So I think that many people worry about a slippery slope, but I think that we can actually identify some very clear principles to arrest that slide and to really try to focus on behaviors that are clear, measurable, and directly linked.
Eric: I think, and this reminds me of when we were talking about using area deprivation index, things like that into allocation resources. I think fundamentally, I just can’t. The practical use of those things, for example, COVID vaccination cards. Restaurants have better access to COVID vaccination cards than hospitals. I never see somebody’s COVID vaccination card, we never ask for that. And I don’t think people think to bring those things when they’re really sick in coming to the hospital. So I think the practical implementation may be very challenging for this as well as just the documentation of whether or not somebody’s been vaccinated.
Eric: I also wonder, when we’re thinking about this model, how much choice did people actually have in deciding whether or not to get vaccinated? For example, how much of this was the influence of misinformation that influenced their decision? How much of this was history of distrust towards the CDC and healthcare institutions from systemic racism and real issues that we’ve done in the past towards particular populations? And how should we think about that?
Govind: Yeah. So I’ll take the second one first, because I think this dovetails what Emily was saying earlier about ways in which things have changed. And if you look back at June of 2021, there were still those large disparities. And I think if you look at surveys done by organizations even the census, you see that change.
Govind: You see the reasons shifting from being hesitancy and there being these racial disparities to, if you look at there’s a very nice report by ASPE which is a part of HHS which basically explains that right now, as opposed to in 2021, the reasons for not being vaccinated much more have to do with… It’s much more, it seems to me from this report, reflecting political ideology as opposed to subjection to past structural racism. Whereas if you had looked in June 2021, you would see much more of that.
Eric: As a political ideology or political manipulation? How much of this is like when we think about how much people, actually we just did a podcast on nudging, nudging people, how much, really, autonomy are they having in this decision versus they’re just being manipulated to not take the vaccine?
Govind: So totally, I agree that there aren’t sort of choices that are sort of abstractly free that are not influenced by anything. I guess what I would say and we could say the same thing, I think, about what we were saying earlier about the legitimacy of considering vaccination as opposed to other choices is there are other contexts where political manipulation may drive you to make really poor choices or in particular not to get vaccinated. But we do think it’s legitimate even if we say, “Look, we understand why somebody would get into the situation.” We feel empathy for them to some extent. We still recognize that it can be appropriate to take that into consideration when deciding how to treat them.
Govind: So I don’t think not getting vaccinated arises to this level, but I think a lot of the people who went to the January 6th protests were very badly manipulated, but that doesn’t mean that it wasn’t warranted to respond to them differently than people who saw all those same misinformation but didn’t go and do that. Similarly, I think many healthcare settings said, “Look, at the end of the day, it’s appropriate to layoff workers who refuse to be vaccinated and don’t have the medical or religious exemption,” even though part of the reason why is that they were manipulated.
Govind: And you can recognize that while still thinking that there’s a difference between the person who faces the manipulation but gets vaccinated or doesn’t commit insurrection and people who are manipulated and then go on to do harm or risk harm to other people.
Emily: I would say too that nothing in our framework is inconsistent with and I think we would actually very strongly encourage, but we’re told we didn’t have a word count to elaborate upon the point that there’s still an important role for outreach and education of individuals, right? This is not a framework that means that we stop trying to increase vaccination rates, it means that we still are engaged in outreach to communities that might have distrust. It means that we’re still having those one-on-one conversations between primary care providers and individuals who are vaccine hesitant to try to educate them and understand and respond to their concerns.
Emily: And all of the things like nudges and the different strategies that are being used to try to promote uptake should be used in conjunction with something this. But it would be an abdication of responsibility not to still have those educational pieces in tandem with a policy that incorporated reciprocity.
Govind: Just to something that you said, because I feel this comes up a lot and I want to understand more what’s going on with it. Because people will say this thing like, “Oh, it’ll be impractical or too challenging to consider it, but I’m wondering whether you think that’s reconcilable with, for instance, the NIH policy, which says you should consider vaccination status to prioritize unvaccinated people for Paxlovid or Molnupiravir.
Eric: Yeah. I think it’s really hard. As a provider, as somebody who has to constantly look whether or not somebody’s boosted and when is the next boost, our EHRs are disjointed, fragmented, doesn’t give us the information we need. And just trying to figure out when somebody got a vaccination for me is exceedingly confusing, it takes a while. And then being on a scarce resource committee during March, April 2020, man, it got really complicated and we spent hours and days trying to figure things out. Despite actually I work in the VA, so having a national guideline, it was still like you wanted to just keep it as simple as possible.
Eric: Again, I hear that the statement, we do have an NIH guideline, it does say to do this. I also wonder though, I get the NIH guideline in part because the population that’s studied for Paxlovid are unvaccinated adults and immunocompromised adults. So we actually don’t have any data on does Paxlovid work for people who are vaccinated? And you can argue probably from an ethics standpoint, one argument could be that there’s a utilitarian argument. You got to maximize lives, right? What’s most likely to benefit? And we know, and even from the little data that we have, the people who are not vaccinated are more likely to benefit than the people who are.
Eric: At least, again, there’s very little data, we don’t have any randomized control trials on people who are vaccinated with Paxlovid. Interestingly enough, Pfizer actually was doing one and then they cut out all the people that were vaccinated. So they probably know something that we don’t.
Govind: Yeah. So I think it would definitely be better to have more clinical trials, but I do think it’s got to be too simple to make the generalization that vaccination status is sort of categorically determinative, right. I’m not a clinician, you can tell me I’m wrong, but if you have a 85 year old that they show up and they’re vaccinated but they’re not boosted, and then you have somebody who shows up, they are, 18 their BMI is 27 and they had COVID a month ago.
Govind: I think it’s pretty clear that even though you might want to say, “Well, there wasn’t any research specifically on vaccinated people,” they also didn’t say, “Look at [inaudible] status,” when they were looking at the trial, probably for Paxlovid. I would be surprised if a clinician said, “No,” since the guy with the 27 BMI in their 20s, he’s unvaccinated so he’s got to be higher risk than the 85 year old, that would be quite surprising to me.
Eric: Well, he wouldn’t. I don’t think he’d qualify for Paxlovid at 27.
Govind: No, he wouldn’t.
Eric: He would just because he’s overweight.
Govind: One risk factor and unvaccinated.
Eric: Yeah. That is, I think, a failure of evidence-based medicine right there.
Govind: I mean, I think it is really tough because NIH has wanted to be very broad in what is considered a high risk condition for really, I think, admirable reasons. So I think I was looking through a list in conditions like ADHD, I think is there as well. And it’s not to say that can’t raise risk at a population level because of things like infection, but the NIH’s list is not, I think, Emily, I’d love to hear your thoughts, validated in any way. And so it’s very strange to us that it has that structure.
Alex: Can we just take a step back? Hold on. We have like nine minutes left. Did we hear from you what your proposal is and how it differs from the NIH’s framework? I don’t think it’s here. Emily, can you just go through how you would change the NIH framework? What would you do differently?
Emily: I’m actually going to pass the baton here to Govind. I think I having heard him do this before, he’s much eager about describing the thought.
Govind: Emily is much clearer than I, but here’s how we would change it. First, I think immunocompromised people under severe scarcity, I would put in sort of tier 1a definitely at the top, don’t mix them in with the unvaccinated folks, immunocompromised, and maybe people who cannot get vaccine for the very vanish and least number of people who have peg allergies and whatever the other allergies you have to have.
Govind: Then beyond that rather than prioritizing unvaccinated people categorically in tier two including the sort of cases where you have people who have a risk increasing condition that may not be that absolutely risk increasing, I think some people who are vaccinated, but are older and have very high risk conditions based on what the evidence shows might end up going above them or alongside them in that tier, as opposed to being categorically sort of deprioritized down into tier three by being vaccinated.
Govind: And that’s particularly true because in a sense, it almost can create… I mean, in practice, I don’t think people would really do this, but it almost creates a perverse incentive not to be vaccinated in that if you’re an older adult and Paxlovid has an enormous mortality reduction, you might be better strategizing to not get that second dose if there really was scarcity which I think is unfortunate.
Eric: Well, I want to just clarify, there’s a mortality reduction in unvaccinated adults.
Govind: No, that’s right. And I shouldn’t imply, I don’t think Paxlovid is more efficacious than vaccination, but I think-
Eric: No. I think the hard part I’m trying to say is that I think this is the hard part when I’m trying to think what are the benefits of let’s say if Paxlovid was still a scarce resource as I think about as a clinician who should be getting it, part of my mental equation is who’s more likely to benefit from it. And in some ways, I think the person who is unvaccinated is more likely to benefit it than that vaccinated person if all things are equal.
Govind: I agree.
Eric: Again, I would also say that I don’t even know from an evidence-based standpoint if people who are vaccinated are really going to see much of a mortality benefit from Paxlovid because we don’t have the data.
Govind: So there is, I think, just a philosophical difference that has come up throughout the pandemic and how to think about cases where you have good clinical trials in one population and not for another and what to do in terms of extrapolating, and I think this has come up time and time again, so I think.
Eric: Yeah. I mean, it’s kind of the booster part of this equipment too.
Govind: Yes, yes. Exactly.
Eric: Do we start valuing people who… Think about reciprocity for those who got the first booster, the second booster, knowing that. Again, the data around second boosters is I would say pretty crappy. That’s like observational studies from certain countries, it’s not great. I think it’s still potentially worth it because the risk harm benefit, but when we’re creating national strategies, man, I’d start feeling uncomfortable if we start doing resource allocation, whether or not somebody decided to get a booster or not, because I’m not sure the evidence is really there.
Govind: Yeah. And I think we would probably agree with… I think, again, reciprocity depends on how big the benefit to the public is from what you did.
Alex: Last question for me, you cited in your article, a Washington Post article by pinning deputy editor at the Washington Post, Ruth Marcus, who talks about how she doesn’t advocate explicit policies around this. She says it’s okay if the emergency medicine physician puts his finger on the scale in favor of the vaccinated and saying that they’re behaving rationally unjustly. Interested in your thoughts on revising this framework at a national level, the NIH framework versus clinicians making individual choices about who to allocate this, a scarce treatment to whether it’s Paxlovid or an ICU bed or a ventilator or a dialysis compounds.
Emily: Yeah. I mean, I think as I said earlier, I feel really strongly that this is about a policy position when there’s resource scarcity and it’s not a decision I want left to the discretion of individual clinicians. I actually don’t think that putting your thumb on the scale for one patient or another because of something that you find morally praiseworthy is a good idea, so I would not endorse that position that she lays out.
Govind: Same. The one thing is I do believe, and you actually have seen this, I think if the NIH won’t add greater clarity to guidelines, I think there can be legitimate room for, say, state level policy variation. And I notice it’s not perceived as ideal by some people, but I think some states really do, for instance, care very strongly about disparities and have adopted. So you actually saw there’s a really interesting paper about this in Massachusetts where they used ADI in prioritizing monoclonals. And I actually think that sort of state level adoption of policies not having would be awful is having the emergency doc be like, “Oh, this person looks disadvantaged, they should be prioritized.”
Govind: But I think having different states adopt prioritization policies as Emily’s emphasizing that reflect their state’s values, I think can be legitimate and often can add greater clarity compared to I think federal officials often love to do this, I don’t know if you all felt like this. Stick everybody in tier one, everybody gets a trophy, and then let the docs figure out how to deal with when there’s not enough for everybody to tier one.
Eric: Yeah. Well I think this is fabulous. I recognize that we’re coming up to the end of the hour. I want to thank both of you joining us, but before we end, can we get a little bit more I Can’t Always Get What You Want.
Eric: Thank you, Alex. And thank you both Govind and Emily for joining us today. That was absolutely fabulous. I love these epic podcasts, I always find it absolutely fascinating and love learning from our guests.
Alex: Fun discussion, thank you both.
Eric: Thank you. And great article.
Govind: Thank you.
Eric: We’ll have links to it on our website. So as always, thank you Archtone Foundation for your continued support and to all of our listeners.