Listen and subscribe on Apple, Stitcher, Spotify, and Google, so you don’t miss the next episode. And if you like what you hear, a five-star rating goes a long way in helping us “Track the Vax”!
Eight COVID-19 vaccines have been approved somewhere in the world, at least for emergency use. In the U.S., only Moderna and Pfizer’s two-dose mRNA vaccines are now available for distribution.
But as the COVID pandemic continues to run rampant, vaccine supply everywhere remains limited. How did different countries decide who gets it and who doesn’t? And what happens to the dozens of phase III clinical trials and their placebo participants who possibly qualify for vaccination with a different shot?
To explore these and more ethical questions related to the COVID-19 vaccines, in this episode we speak with Arthur Caplan, PhD, director of the Division of Medical Ethics at NYU Grossman School of Medicine in New York City.
The following is a rough transcript of his interview with “Track the Vax” host Serena Marshall:
Marshall: Dr. Caplan, thank you so much for joining us here at Track the Vax.
Caplan: Thank you so much for having me.
Marshall: I want to start out by talking about distribution. We’ve seen a lot of problems as the vaccine has rolled out, but one of the first things that had to be determined by the CDC was priority groups. Now they made recommendations for who gets the vaccine.
That was a big ethical question and undertaking. As a medical ethicist, how are those decisions made?
Caplan: Well, it’s been complex as to how allocation and rationing have been handled for vaccines. Some guidance has come from top level organizations like the CDC; there have been states that have, almost uniformly, created advisory panels and tried to come up with criteria.
And then we have guidance coming even from international organizations like World Health. The guidance is fairly consistent, but not a hundred percent. And the more you get down to micro allocation decisions, meaning group A versus group B or decisions within a group, say, prisons. And you’re thinking about guards versus prisoners versus cleaning staff versus visitors. The more discretion goes to the institution.
Marshall: But when you’re talking about those big buckets, the 1-As, the 1-Bs you mentioned states have come up with their own approaches, how do medical ethicists determine who should get the vaccine first? Because without fail, someone’s going to feel left out or discriminated against.
Caplan: Well, let me be clear that in some states, the decisions about how to proceed did not involve medical emphasis or bioethicists. They weren’t on the committees. Their input was not sought. In other states, their input was actively sought.
So when it is, situation where the emphasis weigh in, they ask first: what’s the goal. What do you want to achieve with vaccination?
Given the limits of what we know about the vaccines, you asked the question. Do you want to protect people who are most at risk of getting sick? Or do you want to maintain your workforce in healthcare or do you have other goals? Keep the economy moving, try and vaccinate people who can do that.
They’re also on the side, not as widely discussed, but clearly the military steps in and takes vaccines. Whether anybody else likes it or not, they just do. They don’t care about anybody’s advice. And then there are certainly goals that might involve making sure that the people who make vaccines and distribute them are vaccinated.
That seems pretty self-evident. You don’t want to have them shutting down. So the major question is what goal? And we’ve got some consensus, most ethists would say, protect those most at risk. And if you agree with that, then you get to nursing, home residents and staff, and then you get to healthcare workers with high exposure risk.
And then probably if you’re being ethical, you get to prisons and other congregate settings where people can’t be distanced and are on top of one another. I think those jump out, given that goal.
Marshall: Those two goals, stopping the disease spread versus disease impact and deaths, seem not always aligned with each other?
Caplan: I think that’s right. So if you had a group that was really at risk, but living in a setting where they don’t go out much, nursing home residents. They’re not huge risk factors for spread, right. Maybe the staff has to wear protective gear. Maybe they have to keep distance.
But if you vaccinate the staff and you vaccinate the nursing home residents in a particular location, I don’t think you’re going to do much to control the spread. Whereas if you, or were to vaccinate first-line responders, people who circulate widely in the population, people who might be handling packages for Amazon or UPS and traveling around, police, fire. That’s what I’m talking about. They may make more sense to give priority to for disease transmission. But again, without knowing that the vaccine or knowing how effective it is at controlling transmission, it’s fair to say that preventing harm has driven ethical thinking in this area.
Marshall: What about when you include the things that we don’t know about the virus, like the long-term impact of those who have been infected, the long haulers as they’re so-called that comes down then to do we protect folks with a longer life span versus quality of life for those individuals versus the elder population, which may have a shorter number of years?
Caplan: It’s a great question. I think ethically, most ethicists have argued that even if you’re old, 80, 90, if you’re at risk of dying, you should still have access to vaccination. You shouldn’t lose those remaining years. Others have pointed out, does that apply to people, even in palliative care who are going to die imminently? Do we vaccinate them?
Some have argued that at that point in time, days are precious in ways that might not be true for others. So, yes, personally, I find the palliative care argument not that persuasive. I think that is a place where we would forgo, and ought to forgo, vaccination. There’s just not much time left for those people.
And others could benefit far, far more. I think the nursing home case, you have to do it almost by, case by case. If someone’s 104, frail and got six underlying diseases, they may be dying basically. And that may not make sense. Whereas someone in a nursing home who’s 68 and in relatively good shape may have many years of active life, yet.
The other tough question is what if they’re cognitively impaired? What if they’re demented, what if they have Alzheimer’s, Lewy body syndrome? I’ve still argued that we have to treat them fairly. And unless someone is completely comatose and can’t enjoy life in any way, they too should receive vaccination as priority.
But others, I think hesitate and are not as convinced. So that’s been a close call.
Marshall: In some ways. It sounds like the decision that medical ethicists like yourself have to make, come down to death panels.
Caplan: You might view them positively. And they come down to life panels.
Marshall: Life panels yes..but death panels. It’s probably the term we’ve heard a little bit more in the U.S.
Caplan: But again, we find ourselves in a tough situation because unlike death panels, when you’re trying to decide if it’s ever acceptable to stop available treatment.
When you think it’s futile or pointless. Here, we’ve got ourselves into a mess because we didn’t control the epidemic well. We left people working without adequate mass and PPE. And so spread occurred in many congregate institutions. We didn’t use testing adequately. So we put ourselves again and again, into situations where we have to ration, whether it’s vaccines or ventilators or beds.
So, yes, I would say if you want, you could still call it a death panel, but I don’t like that rhetoric because that refers to a different situation in a different set of criticisms.
Marshall: So how fair though, is it even though there are those restrictions, those shortfalls, when it comes to things like vaccines and PPE to still restrict access to someone and an individual in the vaccination queue, when they have no control over where they line up.
Caplan: Well, I think you have to do what you have to do. If you know, you’ve got a limited supply of vaccine. There’s no other choice, but to decide one way or another, how are you going to distribute? I’ve had many medical students ask me if I’m in or out. Primary care people who come in to visit patients, but aren’t on the staff of the hospital in terms of full-time employment. Are they in or out? What about cleaning staff? What about people who don’t really have much patient contact or working from home, but they’re employed by the health system.
Why are they in the line or why are they in the line at all? Even people asking questions about management. Some of my CEO friends have said, I can’t run this place unless I have my business managers, IT, my record keepers. I got to put them in line, too. It won’t do any good to try and run the hospital if I don’t have, you know, the requisite administration.
So a lot of confusion, and that’s why I said, it’s one thing to say, ‘we’re going to help those most in need sitting in a state Capitol, sitting in the health department at a state.’ When the rubber hits the road, a lot of these tough decisions are being made by the hospital, by the nursing home themselves.
Marshall: How does that public perception of politicians as you kind of alluded to there, other privileged individuals, quote, unquote, cutting the line, affect the process and vaccination efforts?
Caplan: Well, I see some politicians saying they want to get vaccinated early to build trust on the part of the public in vaccination.
And I think that’s nonsense. There’s no evidence and no followup surveys to show that the public is more likely to get vaccinated because politicians did so, even publicly. Or vaccinated their wives or their families. I find that argument just a rationalization for cutting in line and going first, there may be a few politicians and government officials who are deemed essential workers, maybe the president, maybe some national security group, a tiny number of people.
And if so, we should designate them as essential, then list them as part of the criteria. But it says, to having a state legislative person vaccinate and then vaccinate their spouse. Where they’re a family I think is cutting in line and it leads to a lack of support on the part of the public for rules.
People begin to say these connected people are going first, or the rich are going first. Or I heard that somebody bought their way in, or they’re honoring donors at the hospital because they’re rich. If you want rationing and to be orderly and you want it to be accepted, then you can’t have this kind of cutting in line.
Rationing requires two moral values.
One is you need principals to decide how are you going to do it, to help those most at risk. Make sure you identify people that help keep the healthcare system going because they can save lives, both from COVID and other problems. Go to essential workers. So the economy keeps moving, whether it’s water supply, or people who handle our food or people who deliver packages.
But if you see the rich angling in, then people are just going ‘to say to heck with it’ I’m going to do what it takes to get ahead of others, too. I’ll bribe or lie, or do what it takes or create a black market. That’s fairness. So one element is what principles do you follow, that’s justice. But the other side is, is everybody getting an equal opportunity and is the whole system following equal opportunity and that’s fairness. And you need both, otherwise the public won’t support it.
Marshall: At what point though, does a country’s innate values come into play? The United States known for being a capitalist economy, where does that play into that mix?
Caplan: It’s pretty clear that if we need to re-dose, once the government contracts are done, we’re likely to see distribution in the United States by ability to pay.
America is very much capitalist. The whole healthcare system is a market. I think it’s unfair. It’s likely to harm those who don’t have financial clout down the road. But I will predict that is distribution will flow, not so much for the initial round of vaccination or other vaccines coming through because they’re under government control, but that will end.
And then we’ll see the usual problems in a market society of distribution.
Marshall: That brings me to a question on race. We’ve seen Blacks disproportionately affected, other minority races, disproportionately affected, higher severe disease cases. Should they be eligible to get the vaccine sooner?
And should there be a way for those populations to receive the vaccine when we do. As you predict, move to a capitalist distribution format?
Caplan: Look, I don’t think it’s race in terms of severity of impact of COVID. I think it’s poverty and that affects people of minority groups more. If we looked at, and I don’t have data for this, but I’d bet native Americans who own casinos and get good healthcare versus native Americans on a reservation who don’t get good health care.
I’d suspect that poverty fuels the difference. And I believe that’s likely to be true. We haven’t seen any data that says African-Americans are more at risk of COVID because of their genes. I think it’s because of their pocketbook or their lack of healthcare, or the fact that they are more exposed to COVID in the kind of jobs they have. We don’t like to admit it in the United States, but poverty and class drive distribution very much. We like to pretend that everybody will be treated equally. I don’t think that’s so. Do I think we could distribute now, according to race? No.
Do I think we should distribute now, according to poverty? Yes. So it might be by zip code.
Marshall: How much effort should be given though to encouraging those in priority groups to get it? Those who might be hesitant to get it versus just moving on?
Caplan: So the data shows 60% of nursing home staff at Ohio, and many of the facilities around the Cleveland area, saying no, many of the VA’s that have a nursing homes that they run, the families are saying no for the patients.
It’s not the patients. Many healthcare workers are not getting vaccinated. First responders when offered rates of refusal very high. We have a huge problem. We’re not going to control this pandemic until we get more percentage of people vaccinated, particularly in the healthcare system. We are seeing some adverse events from vaccination, but small numbers.
Not huge and they are manageable. I’m not saying it’s fun to get a fever or fun to get sore or fun to have to stay in bed a day. But I think we have to make it clear that COVID kills you and the vaccine may make you sick for a day. The, that message out, more clearly. Sadly, we don’t have good communicators — enough of them.
Start to work with groups, whether it’s the NBA or pediatricians or whoever, the trusted voices are. More messaging, more communication, more fireside chats by the president and others.
Even more situations where the politicians don’t get vaccinated, but they go to a firehouse or a nursing home and stand there and applaud when those people do.
Marshall: Dr. Caplan, I want to talk about clinical trials. This has been a huge question when it comes to how to continue them ethically, should testing continue in those placebo groups?
Should the placebo groups be given a vaccine? How do you determine the need versus the ethical responsibility to maintain these clinical trials as more vaccines come on the market?
Caplan: Yeah. So I’ve written about this a lot, spoken about it. It’s a no brainer to me. We established decades ago that if someone had a treatment, if someone found something that looked promising, you cannot keep people in research.
Even if the research would be very valuable. Even if we’d love to get answers to key important questions that would benefit the public. Every individual has the right to drop out of a study. No one has a duty or an obligation to stay in. I’ve heard some public officials say that we should just continue studies even with the approval of vaccines under emergency use.
Whereas more vaccines get approved, maybe even licensed, that is ethically wrong. It is clearly wrong. We’ve established that you must tell people in studies, we have something new, it looks therapeutic. We’re going to unblind the trial. We’re going to let you know which arm you were in.
Remember if you don’t do that, subjects will go out and get antibody testing and try to figure out on their own which group they might be in placebo or not. We’ll see people harmed as they just go get a shot and maybe already had one and they didn’t know it. It’s not an ethical mystery. You can go all the way back to the Tuskegee study, where people were denied treatment because people wanted to find out the end effects of syphilis on the subjects.
We condemned it, then we must condemn it now. I think we’re going to have to live down the road with less evidence in clinical trials of vaccines than we would like, because more and more people are also going to say, I’m not going to be in a placebo controlled study. You’ve got three approved vaccines out there on emergency use.
I’m taking one of those.
Marshall: We spoke to Pfizer clinical trial participant Kelly Pick… who told us she was disappointed, as a trial participant she still doesn’t know if she received the placebo or the shot.
Kelley Pick: We think this vaccine is great and we can’t wait to get it. Personally, my feelings are that I believe the healthcare professionals, and I don’t want to jump in line in front of anybody else.
From an ethical point of view that I wish everybody could get this all at once, but yet this would not be happening if not for the people that joined the study. When you look at it, I think there was close to 44,000 people who participated in Pfizer’s study. At least 22,000 of those people probably received the vaccine and the other half received the placebo. So out of the 2 million vaccines that have already been put forth in a few days, to me, 22,000, isn’t that many in the grand scope of things.
Caplan: I agree. I absolutely agree. And I think the only point of debate that makes any ethical senses, whether, if you unblind say 20,000 people in the placebo arm, and many of them are not in at-risk groups, should they then just get in line with other people in the same category of prioritization and then be eligible to vaccinate when their time comes. Many of the people in these studies who volunteered are healthcare workers, some are elderly, they’re in the groups that are going to go early and they absolutely should have the right to go get vaccinated.
Maybe it’s the case that if you’re young and healthy and you volunteered, even though we want to honor that willingness to take risk, exposure to an experimental vaccine, we still say we’re going to unblind you, but you don’t get priority because you are a subject. You just get to get in line when your number is called.
Marshall: We’ve been told here on Track the Vax that we don’t just need one or two vaccines. We need a library of vaccines though. We don’t need just mRNA. We need adenovirus vector. We need single dose. As people continue to get vaccination and get their queue in line and get a shot that is given emergency use authorization.
How will that impact though these other trials and the ability to get a library of vaccines?
Caplan: We will get a library of vaccines based on less evidence. People are not going to sign up for trials when you have a number of things out there that they can go and get. Whether it’s emergency use or the first ones get licensed.
There are a ton of questions that we will then have to worry about. Like how long does protection last? Are any vaccines better at preventing transmission? Are any vaccines better at fewer side-effects if single shot ones don’t make us as sick as double shot ones and on and on. But the answers to those questions are not going to come from large scale randomized trials.
They’re going to come from follow-up.
So we really need the Biden administration, companies to pay serious attention because in vaccines for COVID the day of the randomized, placebo-controlled, large-scale trial is going to be over.
Marshall: But what about the ethical responsibility to ensure that there is an easier vaccine that can be transported easier and given to, third world countries, or even countries in rural populations here in the U.S. they don’t have access, for example, to this ultra cold storage facilities?
Caplan: I think those are absolutely obligations that we have. I think we may find out that a single shot vaccine is as effective as a two-shot vaccine. And we do want to know that because it’s costly to do two shots wherever it is. But what I’m saying is you’re going to have to make those decisions on less evidence.
Not more, not none, but less. Because again, if you have, let’s just say in a few months we have four or five vaccines that are out there that people can take and volunteers are drying up because they’re like, I’m going to go get that vaccine. Then all we have is an option. All we have is either to do studies in countries that don’t have vaccine access, which will quickly lead to protests that were exploiting them.
Turning them into Guinea pigs or trying to track what happens when we roll out the next generation of vaccines. Using what I’m calling real-world evidence and follow up rather than randomization to placebo. And I’ll say it again, 10 important questions that will affect vaccination, but the way we’ve gotten the answers in the past cannot and will not work out for getting evidence for the future.
It will be riskier. But there will be less evidence.
Marshall: Dr. Caplan, I want to ask you really quickly about general questions when it comes to vaccination and ethics. Mandating the COVID vaccine is a perfectly legal route for some businesses and one schools may take, but is it ethical to require people to get the vaccine?
It’s a question, you know, my body, my choice that we’ve heard when it comes to vaccines that are already in the market, like the MMR, for example,
Caplan: It’s harder to mandate, I think something that’s out on an experimental use authorization because you are saying it’s, it’s important. It looks good, but we’re not definitive.
And I think people who didn’t want to get vaccinated, it would be hard to stand up to a legal challenge. If they challenge a mandate using something on an EUA. But once vaccines get licensed, we will see mandates within the next week. Healthcare workers, nursing home staff, absolutely are going to get mandated.
You’re talking to someone who instigated the whole idea of mandating flu vaccination for healthcare workers a few years ago now. That swept through the healthcare systems in the United States, they all do it. We will see the exact same thing for those groups. Healthcare workers with licensed vaccines for COVID and many, many employers will be insisting on mandates or telling you to stay home.
If you want to exercise your rights. And I’m going to say you will be unable to get on a plane, get on a cruise, get on a train, get on a public transportation without, on an app, a vaccine certificate proving that you got vaccinated. If you don’t want to travel, you don’t want to go on a cruise. You don’t want to get into a hotel.
You’re free not to do it, but I’m sure those businesses are going to require vaccination. Mandate vaccination, because they want to reassure the public that it’s safe to travel again.
Marshall: How do you see that being played out though? When we can’t even convince people nationally to mask up?
Caplan: It’s true that many people said, “I’m not wearing a mask” or “the whole thing’s a hoax.”
But look, if the airline says: “you can’t get on here without a vaccine certificate,” you can jump up and down and say you don’t like it, but they’re under no obligation to honor you, to fly you. And you’re just stuck. So what I think people will quickly realize is while they may want freedom and they may want freedom of choice.
You’re going to have a heck of a lot more freedom if they vaccinate.
Marshall: And we like to ask all of our guests here at Track the Vax one final question. Have you already gotten the vaccine and will you?
Caplan: I did get the vaccine just recently. I had a sore arm, but no bad side effects from the first shot. I got it because I’m an employee of our health system. And I got it because, not because I’m patient facing. I came up because they’re just running as organizations do, right through the employee list and rightly or wrongly.
If you give a supply to a hospital system and you tell them, use it, they’re going to use it on their employees right down to the end of the line. There’s some guilt about taking it under those circumstances, but I also know better to take it than waste it.
Marshall: Great. Well, thank you so much for joining us here at Track the Vax. A fascinating conversation.
Caplan: Thank you.
Last Updated January 20, 2021
Source: MedicalNewsToday.com
