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Rationing of Scarce COVID-19 Drug Treatments: A Podcast with Drs. DeJong, Chen, and White


The question of who should get limited supplies of drugs that treat COVID-19 is not a theoretical question, like what seems to have happened with ventilators in the US.  This is happening now.  Hospitals right now have limited courses of remdesivir.  For example the University of Pittsburgh hospital system has about 50 courses of remdsivir.  They expect it to last to mid-June, enough for about 30% of patients who will present in the next 3 weeks.   Who do you give it to?   The first that present to the hospital (give it all away in the first week)?   Random lottery?  Or something else that also accounts for the greater impact of COVID-19 has on disadvantaged communities ?

On today's Podcast we talk with Colette DeJong, 3rd year medicine resident at UCSF, and Alice Hm Chen, Deputy Secretary for Policy and Planning at the California Health and Human Services Agency, who were two of the authors of a recently published JAMA article titled "An Ethical Framework for Allocating Scarce Inpatient Medications for COVID-19 in the US". We also bring on our repeat guest, Doug White, who authored the University of Pittsburgh model hospital policy for fair allocation of scarce COVID-19 medications, which can be found here.

The University of Pittsburgh allocation strategy doesn't use a first-come, first-served or random allocation, but rather a weighted lottery that is aimed at reducing the impact of social inequities on COVID-19 outcomes in disadvantaged communities.   In particular, the following groups receive heightened priority in this framework:
  • Individuals from disadvantaged areas, defined as residing at an address with an Area Deprivation Index score of 8 to 10 (range 1-10; with higher numbers meaning worse deprivation)
  • Essential workers, defined by the state’s list of essential businesses that are required to continue physical operations during the pandemic, which include lower-paid workers who may be socially and economically vulnerable, such as grocery store clerks, bus drivers, agricultural workers, and custodial workers.
Of note, the Area Deprivation Index was developed in large part by Amy Kind, Geriatrician at the University of Wisconsin, and recipient of the 2019 American Geriatrics Society Thomas and Catherine Yoshikawa Award for Excellence in Scientific Achievement.

by: @ewidera


  


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TRANSCRIPT

Eric: Welcome to the GeriPal Podcast, This is Eric Widera.

Alex: This is Alex Smith.

Eric: Alex, today we're getting I think close to a record of the number of guests on our podcast.

Alex: We have a record number of guests. First joining us from UCSF is Colette DeJong who is a resident in internal medicine and is finishing tomorrow. She will be chief resident at UCSF. Welcome to the GeriPal Podcast Colette.

Colette: Thank you.

Eric: And just give everybody a primer. Colette was first author in a JAMA paper on the ethical framework for allocating scarce inpatient medications for COVID-19 in the US and that's going to be our topic for today. And that's why we have all these other guests with us.

Alex: Yeah. Second author on that paper is Alice Chen who is professor at UCSF and deputy secretary for policy and planning at the California health and human services agency. Welcome to the GeriPal podcast Alice.

Alice: Thanks for having me. Delighted to be here.

Alex: And returning to our podcast, we have Doug White who is professor of critical care medicine and a director of the program in ethics and decision making and critical illness at the University of Pittsburgh. Welcome back to the GeriPal podcast, Doug.

Doug: Hello everyone. Thanks for having me.

Alex: And we have Lynn Flint who is a frequent host and guest on our podcast and is associate professor at UCSF in the division of geriatrics. Welcome back, Lynn.

Lynn: Thank you.

Eric: We always start off with a song request before we get into the topic at hand but I'm not sure who has the song.

Colette: I requested the song.

Eric: What do you got Colette?

Colette: I requested the King of Wishful Thinking. I can't remember who it's by, but Alex probably remembers.

Alex: It's by Go West, although I'm going to do a cover that I heard on the Internet, but first tell us why you chose this song, Colette.

Colette: Well, first of all it's just one of my favorites. It's from the pretty woman soundtrack as I think a lot of you will recognize. I'm afraid Eric and I are on service together right now and he pointed out right before the podcast that the title sounds really cynical and that's not at all why I picked it. I actually thought that... if you listen to the lyrics, it's about someone telling himself to be hopeful and that we'll get through this. So I thought that was relevant.

Alex: Great. All right. We'll see... Let's have a go at the hopeful lyrics here. (singing).

Colette: Wow, that was beautiful.

Alex: It's blast from the past that's like the... Somebody who said online, that's the most 80s song that was released in the 90s. [laughter]

Lynn: I just had Julia Roberts was just in my mind the whole time. That was great. So I think we're going to get started with just asking you Colette kind of how you got interested in this topic and what motivated you to write this paper?

Colette: Yeah, absolutely. I really don't have much of a background in ethics. I learned a huge amount about it just through this process. But Alice has just been a hero of mine and an incredibly important mentor to me since like, I don't know, one of my very first months of medical school which was years and years ago. So I had heard about how active and what a huge role Alice was playing in the response for California. Initially I thought Alice was probably too busy to even send her an email, but one day I emailed and I just asked if there's any way I could help out and she immediately kind of stepped out of her way to make time for me to join on with some projects. So I got to help out with some projects with incredible members of Alice's team around a few different aspects of the state's response. And then Alice and Bernie Lo and I connected about this paper around allocation of Remdesivir specifically. So that's how I got involved.

Alice: That's being very generous. She has been an incredible asset to the state and just helping us think through various aspects of therapeutics and in particular allocation of Remdesivir being ahead of the curve actually.

Eric: What's the concern with allocation of Remdesivir, but I don't even know how to clearly pronounce it.

Colette: Well, I think just that there's not enough of it right now and that it's kind of the first drug that we have that's been shown to be directly effective against COVID. Obviously we have so many supportive treatments that are helpful, but this being the first drug to really show benefit in randomized control trials. So knowing that Gilead is working incredibly hard to manufacturer enough supply, but at least initially there will be a period where there's not enough and thinking through on the inpatient side, how can we help hospitals to think through allocation of that in a way that's fair and particularly that mitigates healthcare disparities.

Alice: Yeah, I mean, I'll just add that I think at the state level when we're thinking about how do we move from a place where we very effectively curtail the transmission of COVID to opening back up, one of the key indicators that we recognized was therapeutics. And there isn't a lot to be done to accelerate it. We have done some work on the convalescent plasma side in terms of trying to elevate and accelerate that. But in terms of therapeutics, what we realized that Remdesivir was really the only thing in the pipeline that was probably in the near future. So we had been in conversation with Gilead for the weeks before actually. Any of the trials came out thinking that if this did show promise that we need to be prepared for how to allocate it because we knew there wasn't going to be enough to go around. So that's where when Colette reached out, I thought, this is a real opportunity for us to be proactive and be ahead of the curve so that we're ready with our thinking and our framework if this does pan out.

Eric: And just for clarification, when I think about this drug, I also think, hopefully there'll be some other therapeutics out there that will probably also face this issue around limited supply and potential benefit. But what I think about this drug in particular, I think it looks like there is a potential benefit. It's just, it's not a blockbuster decreases length of stay. It may have an effect on mortality, although that was not statistically significant in the studies. And that's kind of where we know about this. We also don't exactly know who will benefit it from most right now. Is that kind of where we are? I'd love to hear your take on this too, Doug.

Doug: I think you, you summed it up really well. It shortens length of stay that P was 0.06 for mortality reduction. So it's a 4% absolute risk reduction. And the group that was included in the study is people with what they call severe COVID-19 which essentially is, you're in the hospital with COVID-19 and you're hypoxic. So you're either, your SATs are less than 94% on room air or you're on oxygen or you're on mechanical ventilation or you're on ECMO. That's what we know right now. We don't have any evidence that there's a particular subgroup that benefits more.

Alex: I'd like to ask, what are you concerned about here? I mean, how is Remdesivir being allocated currently and what is the worst case scenario? What are sort of in the absence of an ethical approach and a guideline based on a set of ethical principles, which we'll talk about, what is likely to happen? And maybe that's what is happening. I don't know if any of you have heard or what's happening in your hospital.

Doug: Yeah. So here's the worst case scenario in my view, is that it goes, it's allocated based really biased criteria. It goes to the wealthy and the well connected and the cronies of leaders who can get their hands on it. I think that would be the worst case scenario. A little bit lower down on the list of bad approaches is essentially what's happening, which is to say most hospitals are using something that looks a lot like first come first serve, because they are uncomfortable apparently with the notion that we have a fixed amount of drug that's coming from the state. And we know that we're not going to get another shipment of the drug for three or four weeks so we need to figure out how many patients are going to need it over that time and then find a fair way to allocate it over time. Because first come first serve introduces so many idiosyncratic considerations and probably really disadvantages people who have poor access to care. So in my view, it should not be allocated based on first come, first serve and there are better ways to do it.

Alice: Yeah. And I hope Doug can actually elaborate on the framework he's developed for his hospital because I think it's really innovative. At the state level, what I'd say is that the Federalists, what's been really helpful in the allocation process that HHS and ASPR has decided to adopt is that they've tried to give us clear visibility about future allocations. So initially when there's so much uncertainty and you have no idea how much is coming out and when the next allotment is going to be there, it's really hard to plan. At this point, they've given us a sense at least through June about the relative volume so that you actually can be more data-driven and more thoughtful and fair most of all in terms of how you allocate the medication.

Lynn: Just to clarify for my understanding, does each state kind of get an allotment and then it's up to the state to distribute to hospitals and then it's up to hospitals to distribute to patients?

Alice: Exactly. So what HHS decided to do is they asked all of the hospitals, acute care hospitals across the country to submit data around their hospitalized COVID confirmed and suspected patients. California is ahead of the curve because we've actually been collecting this data for some time now. So we're able to submit on behalf of our 416 hospitals across the state and based on that data point, they then do a proportional allocation. The States, here in California, we actually do a similar process looking at only confirmed cases and allocate to the counties and then the counties then allocate to the hospitals. And that's just because we're so large, it's hard for us to do it centrally.

Eric: So when we're thinking about resource allocation here, there's the state allocating, there's the County allocating and then there's also what Doug was talking about physicians potentially allocating all potentially using different frameworks for the allocation. I think we're going to be talking a lot about what's happening in the hospitals, but do we want to say anything about how the state or the counties should be allocating this and how that also impacts disparities?

Alice: Yeah. I would say the way we've decided to do this is look, we had a lot of discussion about whether we should adopt the same parameters as the FEDS and we landed on confirmed positive cases. I won't take you through all the different permutations around, testing disparities or conversion rate to PUIs. But we decided to allocate it strictly proportionally across the state in part thinking that a lot of the disparities that have been shown are in actually severe disease and hospitalization rates and that that should be bounced out somewhat in the allocation process. Just to note that for listeners who are here in California next week, we're going to be moving towards a better metric, we think epidemiologically, and also clinically given the data we know about who benefits from Remdesivir which is the number of new admissions and PUI conversions over the last 24 hours. We think that's a little bit more granular and specific about who would most benefit.

Doug: Can I just build on what else Alice said? So I thought it was really important that she said that California is allocating proportional to the number of cases by whatever metric you define proportion by the number of cases as, But it's proportional and so that's different than some other States. So for example, Michigan has taken an approach where they have identified the counties that are particularly hard hit in the city of Detroit and given a disproportionate allocation to those places as a macro allocation technique to redress the really disparate impact that those locations are suffering from. So that's trying to mitigate disparities at the macro allocation level, which is a really interesting idea. I think it gets around a lot of the sort of emotionally charged issues that come up when you have to do this at the bedside.

Alice: We actually had talked about that particularly like when we were talking about ventilator distribution and things like that and not... really trying to get it out of the individual hospital and patient, but at a higher level at the same time. I think the issue for us in California, I know Michigan has done a lot of work over many years around crisis standards of care and has really engaged a broad set of stakeholders. I think in California one of our challenges has been the pandemic has really compressed everything. We have been in the process of finalizing our own state crisis standards of care guidelines. But ideally you would do this before there's a crisis and that you would actually have a very robust process of stakeholder engagement and making sure all the right voices are at the table, particularly people are traditionally underserved and vulnerable. I think that's a process that we're still going through and that we will hopefully have a chance to continue when there's a pause in the pandemic to really be more inclusive in people's input.

Alex: So I want to bring Colette back into the conversation. Colette, when you first were introduced to this idea, coming up with a framework for allocation of scarce medications, what were your initial thoughts on how these resources should be allocated or the ethical principles that underlie allocation of resources? And then what did you learn along the way?

Colette: I think that's a great question because coming to this without having an ethics background, I would say that my thoughts really changed. I wouldn't say they did a 180, but I learned a huge amount from working with Bernie Lowe and with Alice on this paper. I'm on service in the ICU right now and we make so many decisions at the bedside about what someone's prognosis is and whether the risks of something outweigh the benefits and kind of at what point someone is suffering and we need to focus on kind of comfort, focus measures, et cetera. We make so many decisions without having a kind of micro direct evidence to support those decisions just based on our gestalt, our clinical gestalt and our understanding of the evidence.

Colette: So I think I initially thought that the framework would look something like the ICU team knows that there's this much Remdesivir and we think that this person might stand more to benefit. So we are going to give it to that person. I learned just how I think risky that approach can be when it comes to a scarce medication. And learning so much from what Doug and Bernie have written on ventilators, knowing that with life support, it makes sense that by definition we're supporting someone's life because we think that their prognosis is XYZ and we think we can just get them through this period. So allocating ventilators on the basis of something like prognosis has certain implications.

Colette: But with medications, without having the evidence to know who stands most to benefit, those kinds of bedside decisions by the ICU team are subject to bias, I think both implicit but also explicit on the basis of age or perceived quality of life. So through the process of writing this and learning about this with Bernie and Alice and reading things written by Doug and others. What we wrote about is something that encourages hospitals to really stick to the evidence. And when there isn't evidence to rely on something closer to random allocation.

Alex: And let's talk first, two things I want to get to that Colette just mentioned. The first is differentiation. We've had Doug on for two podcasts about allocation of scarce ICU resource ventilators in particular. How is this different? And you just mentioned that it's different in that we don't... Well, there's different in several ways. I want to give Doug and Alice a chance to weigh in on how this is different and how it's the same. And then the other issue that you mentioned which I think is also important is the lack of evidence and tremendous uncertainty here and how that weighs into our treatment allocations. And I guess the third thing that we need to get to is disparities, but we'll get to that shortly. When we're talking about disparities, we're talking about the unequal impact of this disease on African American Latino communities in particular. But let's turn back Doug, I want to hand it over to you to just say how do you see this as different from allocation of ventilators?

Doug: A couple of ways. So Colette hit the nail on the head when she said, we just within the group that met criteria to receive Remdesivir, we don't have any data about who's more or less likely to benefit. And that's a real distinction from, for example, when someone goes on a ventilator, we have a variety of risk prediction tools that can say, "Okay, of the group of people who are on a ventilator, we can very much stratify them according to outcomes based on SOFA scores, for example." So I would say that's a really big difference in terms of the state of the science. I think a second really important difference is the way that people present. So for example, for ventilators it's more often than not going to be an allocation team or a triaged team seeing, "Okay, we have two patients here and one ventilator left. Or we have three patients and someone who's been on a ventilator and we need to choose between these several people."

Doug: But for drug allocation, it's much more about we have a supply of drugs that needs to last us X amount of time. And so we need to be prudent planners over time to say, "Hey, if we're going to have 100 patients in the next three weeks and we have 30 courses of the drug, we need to figure out a way that doesn't give all of the drug to the first 30 if they're not the ones who are most likely to benefit or achieve our public health goals." So I would say those are the two main differences.

Alex: Alice. Any other thoughts from your perspective?

Alice: Yeah. I was just trying to, as looking back as my team has been putting together these fact sheets. I think part of the issue with a new medication is the evolving evidence. So really having to be really attuned to what's coming out recognizing that none of it's definitive, but in the case of Remdesivir where it's so scarce. I mean really we have, there's a big mismatch between supply and demand, really trying to look at rigorously at who might benefit most from both an individual public health perspective but not jumping to conclusions. So one of the conversations we had in the beginning before any of the trials that have been published, it was just the preliminary announcement from NIH is we can't take the kind of observational epidemiologic data around what we know are poor prognostic factors. And then layer that and jump to conclusions about who might or might not benefit from the medication because it could actually be the reverse.

Alice: It could be those that have the worst prognosis generally would benefit most from the medication. So at the state level we've been actually updating our fact sheet so that when data comes out around the duration of therapy or subgroup analysis around the people who benefit most pre-intubation. Like we've been trying to push that out as considerations for people to really think about how to best allocate the medication.

Doug: There's one more difference. It's not about the particulars of ventilators or drugs, but it's about where we are now in the pandemic and the difference is that in contrast to when we were making decisions about ventilators and we really had very little outcome data about who's being hardest hit. We now know that the people from low SES groups and persons of color are being disproportionately affected by this disease. I think that's perhaps one of the biggest changes from six weeks ago that is ethically and at least in my view, ethically relevant.

Alex: Let's go there. So that both framework are far more similar than they are different I believe, and correct me if I'm wrong. But both fundamental, two guiding principles that appear in both frameworks are the duty to steward scarce resources for the good of the public health and the duty to address inequalities in COVID-19 but talking about disproportionate impact on African American Latino communities in particular. Is that right? Do I have just thought sense of those two guiding principles? Is there anything you'd want to add to that?

Doug: Well, Colette and Alice are the ones... Listen, I want to make really clear that what I have developed is merely an operational extension in my view of the ethical principles that they are articulated in that JAMA piece. I don't think there's anything particularly novel ethically about the work we've done to develop the model hospital policy. So I think right on the money. Alex, I would say one thing though. For legal reasons, although the race-based disparities are very evident, we can't do race-based prioritization. It's not legal in the United States, in many States, formative action as a whole sort of separate conversation and it's certainly a political lightning rod. So we have taken the view that looking at socioeconomic status and giving some priority to low SES groups is both an ethically appropriate way to do it and will survive the heat of political and legal scrutiny.

Alex: So rather than focusing on race per se, I believe the framework that you have come up with focused individuals who are from disadvantaged neighborhoods. Is that right?

Doug: That's right. And the reason we should just say New York city has an amazing interactive calculator where you can look at outcomes across groups within New York city. And there are now hundreds of thousands, if not a million cases in New York city alone. What it shows, if you go to click on one of the graphs and say stratify by SES group, they have low poverty, medium poverty, high poverty, and very high poverty. What you see is this incredible direct relationship between increasing numbers of cases, the worst of poverty. And then if you click on death rates, you see the same thing, increasing death rates by levels of poverty. So in my view, that's a clear disparity that is arising from social circumstances. And again, in my view, part of the reason that public health is here is to mitigate those kinds of social inequalities. That's the ethical basis.

Alice: And I just want to add two things. One I think is Doug as very clearly laid out, it's like race-based policies are really contentious, legalistically difficult to balance and require a lot of societal discussion and engagement. I do think the way COVID has played out, there's a clear call to have central workers who are again disproportionately from lower SES communities of color to have special consideration. And I guess I would also say that I would, Doug was like, "Oh, I have just based my allocation scheme on this paper." That's the hard work. I mean, having some guiding principles is I think a starting place, but it's where the proverbial rubber hits the road, which is where the really challenging decisions happen. I would love Doug to share more about the actual model they put together, because I think it's really quite thoughtful and we're sharing it across the state, through our hospital association and to many of our academic medical centers who are grappling with the same issue.

Eric: Can I ask real quick, just because we're on this ethical framework right now, before we got to Doug, I promise, next question. Why what's the ethical underpinning of essential workers? Why do we think that they should receive priority over not essential workers like the gardener, the person who is doing some other job that somebody hasn't defined as essential.

Doug: So I would say, just quickly I'll say two things. First, I think people have a misconception about what an essential worker is. I think many of us, when we hear essential worker, we go quickly to a high wage, high status position, like a doctor or a nurse. If you look at the epidemiology of who is an essential worker, that's part of it but the vast majority are service workers. They work in food delivery, grocery stores, agriculture, sanitation, custodial services. Many low wage, low status jobs are entailed in that. The ethical justification for prioritizing these groups, I would say is twofold. One is to preserve the societal infrastructure to save more lives in the pandemic.

Doug: We need to have an infrastructure to get food to people, to provide healthcare, et cetera. So it's really about a multiplier effect of these people. And then two is based in what we call reciprocity, which is while many people are sheltering in place appropriately, these individuals are being asked to take on added risk of contracting COVID in order to achieve certain public health or social goals. The principle of reciprocity says that we should give them some priority because they're taking risks for society.

Eric: All right. Two questions then is if we start opening up our economy, more people can go to work, everybody's then taking risks. Does that then negate the second part, which is now we're all taking risks? For the first one, we had this guy on our podcast. I think his name was Doug White. And he told us like, when we were thinking about ventilators, it's like the odds are, if somebody is going to need a ventilator, they're not going to go right back to the workforce right when we discharged them from the hospital. So do we expect the same thing with novel drugs that we give them a great, they can get back to work in two weeks and continuing their essential work?

Doug: I think so. I mean, I think we're seeing this is going to... this unfortunately is not going to be over in six weeks. And many of us thought about the pandemic as something more on a really sort of narrow timeframe before. And now we're looking at this extending out over a years, but unfortunately. So I do think that it's very likely essential workers if treated would get back to the front lines quickly.

Eric: And would you also agree with like potentially expanding who would be included to anybody who is going out to work because then we're all taking risks.

Doug: Well, each state articulates their view of who are the essential workers to maintain social cohesion in the public health and state infrastructure. So I think those are the groups that should be prioritized because they're being called on. Even if they could conceivably work from home, they're being called on to do their work or actually I guess the way to say it, as many of them can't work from home. So they have to take on these risks that many of us we can do much of our work from home.

Alex: Alice, do you want to jump in here?

Alice: I was going to say, and I just think again, talking to Doug and hearing about the framework they put together really helped me clarify. It's not a binary issue whether you're deserving of the drug or not. It really is about should you have some weight or some acknowledgement of the additional risks that you're taking. I do think that the core essential workers that we've defined really are folks who can't shelter in place and are particularly in the early stages of the epidemic, when we didn't have sufficient PPE even for healthcare workers, let alone our transit drivers, our grocery store clerks, really did deserve a special consideration for the reasons that Doug outlined. I don't know that I would say that that's easily broadened because I think as we go forward, we're going to see NPIs go up and down. And again, that core group of people who really won't be able to dial it up and back I think in my mind are the essential workers.

Eric: And because we're talking about the framework, Doug, do you want to give us an overview of the framework? We will have links to Doug's framework on our GeriPal website but Doug, can you give us an overview?

Doug: Yeah, it's probably easiest just to sort of lay out the situation and Pittsburgh to help people kind of understand how we're applying it first. So in Pittsburgh, UPMC, which is a 40 hospital health system, we have 50 courses of Remdesivir and we expect it needs to last through mid June. And we are getting, we're seeing about four cases a day who would meet criteria in the system. So if you sort of do the math, we have enough for about 30% of the patients who are going to present over the next three weeks. And what that means is that we need to make some choices. We could just give it all. Give it to the first 30 people who come and then we're done and we say, well, we don't have to ration because we don't have the drug. We have the drug, we didn't ration it and now we don't have it anymore and we don't have to ration, but that obviously that's not quite true. We're rationing by giving it all away first.

Doug: That's why I think a first come first serve approach is so problematic. So we have scarcity in Pittsburgh. We developed a framework that is what's called a weighted lottery, which is to say, if the baseline chances of getting the drug are 30% every person who would be eligible to receive Remdesivir in the trial, that's the entry for being eligible to get the drug in Pittsburgh should have a chance to get it. And the chances should be adjusted slightly based on three considerations. First, are you from a hard head or a socioeconomically disadvantaged group? And we're using something called the area deprivation index to define that. It's an address based marker of economic disadvantage.

Doug: And if you're in the most disadvantaged group, you have a somewhat higher chance of getting the drug. So let's say that the average chances are 30 out of 100. These people's chances from low SES areas might be 36 out of 100. So that's number one. Number two, are you an essential worker as defined by the Commonwealth of Pennsylvania? And if so, you have a similarly increased chance of getting the drug in the lottery, 36 out of 100. Then the third is if you are someone who has a very poor near term prognosis, your chances of getting the drug should be less. The idea being that you're expected to die within a year, even if you survive your COVID infection, public health goals of maximizing community benefit won't be served by prioritizing those people.

Doug: So the chances for that group, won't be zero, but there's something closer to like 15 out of 100. So you end up with this sort of grid, and there are different permutations if you are an essential worker from a low or a high poverty area, your chances are different doubly high. So for each patient who comes in, who qualifies, we basically do a random number generator between one and 100. And let's say that this person's chances based on the stratification on those three variables should be, they should have a 36 out of 100 chance of getting the drug.

Doug: So we run the random number generator. If the number is 36 or less, that comes back, they get the drug, if it's 37 or higher, they don't. We do that for each patient over time. So over three weeks, that's how we treat all patients. We don't change the odds unless we get a new shipment of the drug or unless it's really clear that we're getting way more or way less people than we expected.

Eric: And have you started this yet?

Doug: Yeah, we started about 10 days ago. So this is how every day we get on a Zoom call, we have a spreadsheet that shows us only the variables that I just said. So I have no idea how old the patients are. I have no idea their race, I only know their address, whether they're an essential worker and whether they're at the end of life and we just run the lottery for each of them.

Eric: That's interesting because I worry, like when I sometimes read New England Journal pieces from Zeke Emanuel, I think that's never going to happen. They're like the King of wishful thinking, but it sounds like you are not -- you actually created something that actually that you could run and you've been running it for the last 10 days.

Doug: Yeah. I mean, this is what's amazing about the drug issue, the scarcity of therapeutics is that it sort of came up on us incredibly quickly and has gotten not a ton of attention in the lay press or academic journals. In contrast to ventilators where it was this theoretical thing that there was so much smoke, but no fire and it never happened. And yeah, here we are. I mean, we've been rationing Remdesivir for a week.

Lynn: One thing that's going through my mind and that I'm glad to hear you're doing it because you can tell us the answer to this, which is how are primary teams sort of how's the communication going? Because I could imagine one scenario where frontline providers would really be wanting to advocate and push back against your random assignment versus others who might express sort of great relief that they don't have to make the decision. So I'm just curious what that's been like.

Doug: Yeah. It's been incredible in ways that I didn't exactly, I couldn't have predicted. Certainly, Lynn, what you mentioned about providers advocating for their patients is definitely happening. But we're also seeing the reverse, which is to say some of the clinicians are saying, "I'm not sure this is... maybe you should give the drug to someone else," for reasons that I chose not to push too hard on but felt a lot like quality of life considerations. So I actually think there's something really valuable about taking, of having an out location team who's not the clinical team saying, "We just need this information from you and then we're going to make the decision about whether we're going to run the lottery and then the patient should be offered the drug or not offered the drug." To sort of get away from the biases that good or bad can come from frontline clinicians who may not understand how much Remdesivir we have, what are the ethical issues at play, how we need to guard against certain biases, et cetera.

Alice: And Doug, are you waiting for clinicians to request it or are you proactively identifying all COVID cases and entering them into the system?

Doug: Yeah, the latter. We felt like it was really important to proactively screen again to minimize bias. So we've been having our pharmacy and IT colleagues every day screen all of the hospitals, electronic health records for, are they COVID positive and are they on oxygen or are they hypoxemic? And that gets a closer scrutiny of each patient to figure out whether they would be eligible to enter the lottery.

Eric: And let's say I appeal, I didn't get it, but I say, "No, no, no, I was Totes an Uber driver. I think that's essential. I just forgot to tell the person that was my occupation."

Doug: Yeah. So we have an appeals mechanism built in place. I think it's very important to have that kind of mechanism. Here it's, if people are saying we disagree with the ethics of the framework, that's not grounds for reversing a decision. That's a broader societal debate that can't happen at the level of the hospital. But if they say, "Listen, I think you just got it wrong." Or different doctors says, "I think you've got something wrong," then absolutely. And the appeals process is basically having leaders in the hospital. Three, three leaders sit down and look at the case and say, was the framework appropriately applied. And if it wasn't, then there needs to be a change and if it was then things stand

Eric: Now, me and Colette were talking about earlier about this essential worker. Let's say like I'm a physician, but I'm just mainly doing tele-health with my patients, I'm really not doing any increased risk, I guess I am making sure other people are staying healthy. Does that come into play at all? Or is it just black and white? Do you fall into these categories.

Doug: Black and white. It's just too hard to make these very subtle discernments about, well, what is your risk actually high enough? Or did you actually see most of your patients from home doing telehealth? This is a public health intervention, it's an instrument of public health, which frees us up and makes us think, I think more at the macro-population level rather than are we getting it right for every individual patient. Is we're trying to get it right for populations on average over time.

Eric: Well, that's the interesting thing, I was playing around with the ADI, area deprivation index, yesterday. I like most think, oh yeah, that seems right. That seems right. But like, there's this area of Tiburon, which is this very toney part of Marin and there they were red. They were in like, "Oh, wait a second. That can't be right." You're going to have these because these things are based on big population studies. So there's going to be some wrongness to it but it's really, you're saying we've got to look at a little bit bigger than just the individual level.

Doug: Yeah, exactly. That's why I think conceptualizing it as a public health intervention is critical rather than saying this is bedside doctors or ethics committees at individual hospitals making these decisions. Because that makes you, that frame of thinking is the clinical ethical frame. And that's not the right frame to be thinking about why we're prioritizing people from impoverished communities.

Lynn: Yeah. I will have to say for me, that is my big as a relatively inexperienced number of our ethics committee. To me that was really the sort of big take home learning point, going through all this, is the difference between sort of a public health framework and a clinical framework. I could imagine, and that's why I was asking about the frontline clinicians kind of budding up against that or having to really offer that education as you go through this each time.

Doug: Absolutely. Yeah, no, it has been remarkable to have to sort of talk clinicians through this is not bedside decision-making at one on one, as we normally do. There are certain public health goals that we're trying to achieve and they diverge a bit from our normal clinical goals. Actually this is where I wanted to ask Alice, as a public health person and really thinking about what are the things that States can do in the name of public health? Is it okay to say we have these horribly high death rates in certain communities, can we use public health as an instrument to lessen these disparate outcomes?

Alice: Yeah. Again, I think those are definitely questions we're grappling with in terms of going beyond. I mean, obviously because a lot of these communities are disproportionately hit, proportionally allocating the medication based on the hospitalizations or deaths addresses a little bit of it, but how do you actually readdress some of it, I think is a much more difficult question requires a lot of vetting which we right now have not had the luxury of doing. We're trying to do it, but I think what I was going to say is that in terms of this kind of public health allocation, I think the key principles really are to be transparent, to be in having like frequent and clear communication. Every time we do an allocation, we post it online. We make sure that it is publicly available where every vial of Remdesivir goes in California.

Alice: We've asked all the counties to actually be public about which hospitals they are giving it to on what cadence. I think that goes a long way and just having a clear methodology that is as fair as possible, that is data-driven sidesteps a lot of these issues because we have individual clinicians, individual hospitals, individual counties approaching us to try to get additional supply. I mean, honestly, all we can say is we are trying to do this in the fairest way possible with all the information we have and if people have better and different ideas, we're completely open to them, but it has to be public, none of these side conversations.

Eric: Yeah. I think one of the issues we had with testing early on, it certainly seemed like if you had money, if you own an NBA team or an NBA player, certainly got easy access testing, but the rest of the people even essential workers didn't. So being open and fair. I want to turn to you Colette. This is my last question. Hearing all of this, how are you thinking about Doug's framework and does it fit in with kind of how you were thinking about this too for your JAMA piece?

Colette: Yeah, absolutely. I mean, it was really a learning experience to see how Doug was able to kind of instrumentalize some of these really challenging things. Like how do you not give out medication first come first served. So I learned a lot from reading how Doug implemented it. One thing I'm just thinking about, I really liked the words Alice was using fair as possible. I'm thinking about the VA ICU in San Francisco right now, and the fact that I'm ostensibly taking care of COVID patients, but in fact have basically hardly been in the room. And there are nurses and respiratory therapists that are going in every single hour doing procedures, like truly being exposed in a way that is just worlds apart. And thinking about the implementation of even this very carefully thought through ethical framework.

Colette: Imagine if let's say was a 50/50 chance whether I got the medication or one of our bedside nurses got it who's... I probably got it at the grocery store, if I caught COVID, that's how little my risk has been. And not taking into account the fact that let's say this nurses 50 years old and has diabetes and might have higher risks of poor outcomes. It's just such a painful process of thinking through this kind of allocation and do the best we can.

Doug: Yeah. If I could just say I see Alex getting the guitar going, that's the hook I think. But as I've been thinking about this, I really think that the level of operationalization shouldn't be individual hospitals. I get that that's how States have chosen to allocate, they give it to the hospital and then the hospital makes the choices. But now since we have Alice on the line, I mean, I think that there are so much to be said for having a little bit more of a regionalized approach rather than a hospital based approach, because it gives, if you're really rationing, it suddenly gives you an opportunity to both ration and get away from any of these issues Colette talked about, but then also learn from the rationing.

Doug: A lottery is essentially a form of randomization. So this was happening at the regional level, we could be following, putting in a requirement to follow outcomes for everyone who came to that central, they made the call and said, "I have a patient who I'd like to get Remdesivir for. And then the department of health, for example, runs the lottery and either gives them the drug or says, "No, we don't have drug," but then follows everyone out. If you do that for 2000 patients, which would not be hard in California, for example, you have a huge randomized natural experiment.

Alice: Yeah. And I will just put out some [inaudible 00:48:25] for one second, which is I think you're exactly right. I think for example, in California, we have 58 counties. They vary tremendously in terms of their infrastructure and workforce and LA County has actually done this. They've actually created a registry where they have given out the medication to track outcomes, but not the randomization at the point of contact. I think what I would say is that, ... this is this isn't going to come out the right way, but in some ways we're fortunate that Remdesivir is a silver bullet. I mean, so I think when we do have something that is much more efficacious we need to be prepared for that.

Alice: I think that all the things that we're doing here. So I just want to really thank Eric, Alex, Lynn, for having this conversation, because I think we actually need to have this be a very broad conversation, have many people actually be implementing and operationalizing this so that we're ready for the next medication, which is hopefully inevitably going to come and will hopefully be even more efficacious in Remdesivir.

Eric: Well, I want to thank you all and we are coming actually past the hour. So before we say goodbye to everybody, Alex, we are going to be wishfully thinking that we have a better drug in the near future or a vaccine.

Alex: (singing).

Doug: Bravo.

Eric: I was actually just watching contagion a couple of days ago with my family. And it just made me think -- they did a lottery at the end for the vaccine. I'm all, oh man, this topic is...

Alex: I thought you were going to say you were watching pretty women with your 10 year old child. [laughter]

Eric: Well, I got to say, watching Contagion with my 11-year-old child was pretty tricky. [laughter]

Alex: Thank you so much, Doug. Thank you so much, Colette. Thank you so much, Alice. Thanks for joining again, Lynn.

Lynn: Sure thing, thank you.

Alice: Good to see you guys.

Colette: Thank you.

Lynn: Bye.

Alex: Bye everybody.

Eric: Thank you Archstone Foundation too for your continued support and all of our listeners for everything that you do and hanging in with us. Stay safe.



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