Allocating Scarce Resources with Dr. Jennifer Bell
In this episode we discuss another success story with Dr. Jennifer Bell who helped her medical center think about how to ration scarce CAR-T Cell cancer treatments.
Transcript
0:00
Welcome to this episode of Bioethics for the People, the most popular bioethics podcast on the planet according to Grandma Nancy.I'm joined by my Co host Doctor Devin Stahl, who dutifully completes the same 5 New York Times puzzles every single day.
0:17
And I'm joined by my Co host Doctor Tyler Gibb, who if he weren't here right now, would probably be golfing.All right, Tyler, so we have another success story to share today from a fellow Canadian.Yes, I love Canadians, of all the nationalities, they're my favorite.
0:37
Have you ever, I don't think you even talked about this in the podcast we did about you, Tyler, is that you're Canadian?Well, kind of Canadian.I was born there.I can have dual citizenship if I ever fill out the paperwork.Oh, you've never filled out the paperwork?No, it's like $125.00 fee and I've never never actually filled it out, but.
0:55
That says something about your like extreme optimism about our political situation that you've never like in the back of your mind, Go said maybe Canada might not be such a bad choice for me.Yeah, maybe this year will be the difference maker though.We'll see.OK, so we've got a Canadian with us.
1:10
Well, I'm actually dual citizen.Yes, dual citizens are the best.I grew up in Georgia and now I live in Toronto, so.All right, so we've got Jennifer Bell with us, who's a senior bioethicist up north of the border, and we'll let her introduce herself.
1:27
Yeah, well, I I already told you more about me than I think I tell the average person.So I am.I won't start from birth.I'm currently a senior bioethicist in Toronto, ON and Director of Bioethics Research.I'm at the University Health Network and I'm affiliated with the University of Toronto.
1:47
Very cool.So, Jen, what does your day-to-day look like?Well, I mean, actually it's changed a little bit because I just was awarded a fellowship actually in AI and compassionate healthcare, but previous to that, which I just started a couple of weeks ago.So I've been seconded to that and it's a research fellowship, but, but prior to that my, my day was very clinically oriented.
2:10
I mean, I provide clinical, organizational research and policy and education ethics across our organization.I primarily support Princess Margaret, which is our cancer hospital.But organizationally, I do a lot of work for the entire organization as it goes.
2:28
So, you know, day-to-day it's, I mean, as those of you who work in healthcare settings and our ethicists there and you're sort of beholden to what kinds of consults and questions come up and you can never really anticipate what those might be.So that's sort of exciting, but also a bit daunting because you know, you're called on to be sort of have knowledge about all these various areas.
2:51
But it's sort of a generalist in a sense, at this hospital at least, because I, again, serve a larger population than just the cancer system.So it could look very different depending on the day.But generally, I will be responding to a clinical consult, a bedside consult.
3:09
Maybe there's a policy coming through that needs an ethics perspective.Right now, we're in the midst of creating sort of AI protocols and procedures.And so there's a lot of opportunity there for ethics input on that.So, I mean, it really varies, yeah.And I know that Tyler has experience with this too, but I've been part of hospital systems that get like 1 consult a year, and then I've been part of ones that get more like 1 consult a day.
3:36
My guess is you're getting even more than that.So what is your typical load like?How often are you being called to consult?Yeah.Well, I should preface this.I'm not a sole bioethicist working in this network.Actually one of five others.So there's six of us.We're not all full time.
3:52
So me in particular, I have 3 days that I devote to practicing ethics in the healthcare in our, in our healthcare network, but I'm also paid to do research.I have a nice dual role, which is it's hard to come by, at least in Canada.
4:08
I don't know how frequent you have these opportunities in the States, but so my day, my week is actually split into normally it's changed a bit now because I've started this fellowship, but before this it was three days clinical organizational research ethics practice and then two days I had devoted to actually conducting research and bioethics.
4:28
I would say that's incredibly unusual.That is a lot of time for research.That is really cool.Yeah, yeah.And it's not grant funded either.So it's it is a permanent sort of part time research position, a full position in its entirety, but the research side is actually well as guaranteed as you can be.
4:47
That's cool.One of the topics that we're covering on this kind of series group of episodes is success stories.What we want to do is highlight some of the good work that clinical ethicists are doing.Number one, because they, I think clinical ethics and being an employed clinical ethicist is a fairly unusual type of position.
5:06
Most people don't know that this position exists, but it's easy to envision, you know, the worst case scenario or really terrible cases where an ethicist is useful.But sometimes those get sad and those get heavy.Those talking about those cases all the time.
5:22
So we wanted to talk about success stories.And so you have a success story that you are going to share with us.Yeah, Yeah, I do.And thanks.And it just, it just dawned on me that I didn't actually answer Devin's question about how many consoles we get.I I was leading into it and then and then digressed.
5:40
But as a snapshot, because we have, you know, almost 6 at the system varying kind of responsibilities to ethics within our service, we have around 350 consults a year.I don't know how to make sense of that necessarily.I mean, that's one of the questions of our, of our profession, of our discipline is how do you benchmark this?
6:00
But but yeah, we are a busy service, a very busy service.And actually the success story stems from an organizational ethics consults.So actually most of my work has tended to be at the Cancer Center and it's tended to be organizational in nature.
6:16
I think that might be because I'm there three days out of five and I'm just not, I'm not as present on, on the units walking around or participating in rounds as much as maybe I would be if I were there five days.I mean, I think that might be some reason.
6:32
But I have also just had a lot of uptake in terms of organizational ethics issues and leadership has brought me on to some of these issues and it's just kind of propelled from there.So the success story that I wanted to share with you all is an organizational, I'd say organizational ethics success story in the sense of success of being involved as an emphasis being included embedded I think in the process and the questions.
6:59
It was an important and still is actually an important issue that we're working through at the Cancer Center that, but that's the setup.It might be helpful to some of our listeners who might not be as familiar with the work of clinical ethicists to just describe briefly the difference between sort of a clinical ethics consult and an organizational consult.
7:19
I generally understand those as a clinical would more come from a physician or someone on the healthcare team, maybe even a patient, other family members saying like what's happening here doesn't seem quite right or there's an ethical dilemma I'm seeing at bedside versus an organizational question might be more like the process itself that we have some sort of policy that we have doesn't seem to be working for us.
7:40
So we need a higher level console that says we need to think about how our systems are running.Is that how you make that distinction?Yeah.I think that's a really, that's a really helpful distinction.I would have made something similar, but maybe not as eloquent.
7:56
Yeah, clinical ethics is more about direct patient care.We got consulted by all those parties that you just mentioned.Many people don't know, especially patients or public members that they, at least in our service, they are free to contact us for a consult.They don't need to pay for it.
8:12
So that's something we're always trying to strive for in our services to let people know that they can contact us, doesn't have to be the healthcare team contacting us.And then organizational, yes, just as you just described, I'm often involved in policy guidelines, anything that would sort of touch a systems level of how a practice might operate or a program might function that has ethical components to it.
8:39
I mean, lots of ethicists I know have been involved, for example, in informed consent policies in their institution.So that's a, a pretty typical 1.And I know, you know, we talk sometimes about these hybrid cases.My colleague Sally Bean has a great article describing hybrid cases where you might have a clinical ethics consult, a patient, a consult involving direct patient care.
9:02
I'll take an example from my own practice.We had a patient that was uninsured in Canada.We have public insurance, but it's only available to those people who have status in Canada, that being immigration status.And that's how we define uninsured or insured government provided insurance.
9:21
And so there's going to be some folks without that eligibility and don't have the access.So we've had many consults that arise during direct patient care about whether we should or should not, the healthcare team should or should not provide care to certain patients who are uninsured.And as a result, a long time ago, I developed with senior leadership a policy around how the hospital ought to approach this issue.
9:43
So that's a good example, sort of a hybrid case where an organizational ethics issue is informed by a clinical ethics case.Yeah, in my experience, that's almost always how they go is that somebody identified something on the bedside that then needed a policy to make sense of, like how we would think about future cases.
10:01
So how did this case or this success story, how did it land on your desk?So for the success story, I have to actually go back several years.This was pre COVID when it landed on my desk, so to speak.So it was 2019 and I have been quite involved in the self therapy working groups at Princess Margaret's.
10:25
So like prior to this, the stem cell transplant program and we had actually written a paper and developed a process around prioritizing patients to stem cell therapies.And so I knew this group very well.And the director of the cell therapy, the cell effector therapy program approached me basically and said, look, we have this cellular therapy, it's called Karti cell therapy.
10:53
This is a kind of immunotherapy for cancer where you take your own immune cells, you engineer them and make them better able to attack cancer.This is a, you know, highly specialized therapy.It's very resource incentive.
11:10
It's very expensive and it's only performed at specialized centers.Princess Margaret being one of those very few centers in Canada, and I know in the United States there's also select centers that apply.Not every center has a cell therapy or CAR T cell therapy program.So she approached me actually and said, look, I'm really concerned about the way that we're currently allocating very scarce spots of this CAR T cell therapy to patients.
11:38
We come together currently, we discuss the patients that are eligible, but you know, I'm worried that it's not.It could be better.Like the process for deciding which patients should get the next slot.This process could be better.She was worried about the squeaky wheel effect where a patient's physician might just be more vocal about a patient and it might just that patient may rise above the others then in the decision making.
12:03
And she just wanted some guidance and transparency and really an ethical framework around this process to support it.That is like when we teach about the first dialysis committee that had to decide.So they were like hundreds of patients, thousands probably around the country who and but like 3 dialysis machines and the physician says Yikes, I can't just make all these decisions on my own.
12:26
I need an Ethics Committee.And in that case, they, I think we've talked about this on the podcast before, found like representatives from the community to do this who ultimately made some pretty biased decisions.But now we have these professional ethicists like yourself presumably have some expertise in this and now you're being tapped to do it.
12:43
So it's like a different model then.It'd be great to sort of compare this at some level.You should I'm, I'm always good at telling people what they should be writing.Do a comparison of like those kind of original committees that were formed.And and this like has a similar sort of problem.But now we have a new profession that's that is there to address it.
13:02
And so can we do better than the original dialysis committee that what they used to call the God committee?Yes.So this, as you say, this is not a new ethical problem.The clinical context had changed.We're not talking about dialysis anymore, but we're, we're and we're not talking about transplant because we know we still have this in, in solid organ transplants where the organs are extremely scarce.
13:25
This is a bit different.This is our T cell therapy is it's not, it's not an organ, it's it's a product.It's a product that's made from a patient's own cells.It's engineered.It's a little bit different.It's not an absolute scarcity.I suppose that's the difference.
13:41
There are other things that make this product scarce or limited.So there's capacity challenges, for example, manufacturing challenges.It takes a lot of people to be able to make this therapy available.So I, I can get into the various challenges if you wanted, but suffice to say that this is a therapy that is very, very, very intensive, complex and and only performed at very limited centers.
14:12
And presumably very expensive.Yes, very expensive.So I think, I mean the last number I heard was it's $500,000 a product and I'm not sure if that actually includes all of the bedtime.Sometimes these patients need to go to the ICU.
14:29
So I think that's an average, but it could, I think it could be more than that given all the needs that sometimes go along with it.So incredibly resource intensive type of therapy.Remind me, what type of cancer is this treating or or what types of cancer is this useful for?
14:48
So it's, it's been approved for blood cancers mostly, so leukemia, lymphoma cancers and it's been used mostly third line.So these are, these are patients who have tried several lines of therapy already and they're now on maybe their third line and nothing else has worked.
15:09
And CAR T, they are eligible for CAR T at that stage.It's going to be available for multiple myeloma.In fact, the product may have already come out two months ago here in Canada and may be more available in the States earlier, but it's the blood cancers.However, I will say that in clinical trials, CAR T's being explored for solid tumors as well.
15:30
It's sort of lots of people are very optimistic about CAR T cell therapy, but it just hasn't shown yet to my understanding, as great of benefit or usefulness in solid tumors as it has in blood cancers.Janet, sounds like you know a lot about cancer.
15:46
I mean, it makes sense that you're in the you're in the cancer hospital mostly.But for your kind of work and for what you are tasked to do with thinking about resource allocation, how important was it that you understand cancer, like the pathophysiology of cancer, The, you know, sort of the mechanisms of cancer, the science of cancer?
16:05
How much of that is really important for you to be able to know in order for you to think about resource allocation of this chemotherapy or this immunotherapy?Oh my gosh.I think this is almost an existential question.Yeah, Because I, I struggle with this.I want to know as much as I can.
16:22
I try to learn as much as I can.It's, I mean, obviously it's beyond me.Like this field is just so fast-paced, so complex.I went to a conference last year in immunotherapy, the bio can RX conference in Canada.It's, it's really pushing the boundaries of our T cell science and just sitting there to look at all, all the various permutations of vectors they're exploring like ways to get the cell into the engineered cell back into the cell and, and what should carry it in there.
16:50
Like it's just beyond me.So I, I try and just have a basic level of understanding at least to be able to converse with people and ask good questions.But you really, I really rely on my colleagues to, to fill that medical gap.
17:10
Obviously I'm not trained in medicine so doesn't come easy.So you were approached to help develop this allocation process for this particular expensive, high resource intensive cancer therapy.So how, how do you even approach the question?
17:26
Like how do you even get started on something like this?As as you may or may not know, you know, I come from the background and philosophy.And so I, you know, I've studied John Rawls, I've studied different models of justice in theories.
17:42
And but when it comes to actual sort of clinical application of some of these series there, it's difficult.So when it comes to problems of distributive justice.So this is problems of justice where demand outstrips supply and decisions need to be made about how to allocate.
18:01
There are some raining sort of philosophical approaches.So you could take a utilitarian approach, which would just mean trying to maximize benefits to the majority of people.When you look at the literature, because you as an ethicist, part of I, I see part of my job is going to the literature to see what's been tried, to familiarize myself with the theories and a possible approaches and to do some evaluation on my own about what might be most applicable to the situation that I've been consulted about.
18:34
But generally, I mean, utilitarian approaches have been criticized in problems of distributive justice because you still land up with or you still end up with discussions around, well, what counts as maximizing benefit?What is benefit?And then we get into discussions or disagreements potentially about what benefit might mean.
18:54
Is it elongation of life?Is it quality of life?You know, there will be disagreements.And then obviously utilitarianism as a theory fails to consider properly or appropriately the needs of the less well off or the minority because it's very much concerned with what the majority is owed.
19:12
The other approach in the literature for distributive justice problems is an egalitarian approach where everyone deserves equal based on personhood, deserves equal amount of resources distributed to them.But obviously the first problem there in this situation is that there isn't enough resources to go around to everyone.
19:32
And so we can't give everyone equally the amount that they deserve.We can't give everyone a slot for car T because we are very limited in car T slots.And that's why we have this problem where we need to justify why one person should get it or be prioritized over somebody else.
19:50
Or could somebody wait and this person get it now or, or are they not fit to wait?So egalitarian approaches also sort of fail the test.And so in the literature, of course, there's recognition, I guess, of these limitations of these two approaches to distributive justice.
20:07
And somebody very smart developed an accountability for reasonableness model.That's right, we don't remember anybody's names.So that you can edit this.No, there are some people who are like so good about saying this person thought this and wrote this or like lawyers, sometimes they're really good about saying like this versus this case and this court said, but we are not like that.
20:30
And yeah, so somebody smart said something smart, right?You are my people then.Yeah.So they developed accountability for reasonableness, which is really just a process for making decisions.So it it outlines various principles that ought to be met in a decision making process where reasonable people disagree.
20:55
And so we already know reasonable people are going to disagree.In this situation, we're going to have debates about should this person go or should that person go.And so this process, accountability for reasonableness sets out some criteria that a decision making process ought to meet in order to be considered fair.
21:13
There are several stages in application.So as an ethicist, I came in then and suggested we use this approach, accountability for reasonableness to tackle the ethical issue of prioritization of patients to CAR T cell therapy given the disagreement and given the scarcity of CAR T cell therapy.
21:33
So this reasonableness account is published in the literature and and why did you think that this would be the best approach?I mean, why not just lean into utilitarianism like that?Seems like the most cut and dry to me.Yeah, I mean, we did have discussions and so in our process, you know, we invited different parties.
21:50
So part of accountability for reasonableness to go back to your diet to tell us this example, one question might be, well, who was at the table or at the where?Was it the right people at the table?And if, you know, a certain group was left out, could that have been a factor in arriving at what we would now consider a skewed outputs or decisions made, You know, that we would now reflect on and say, well, maybe this wasn't quite right.
22:15
And so part of the process for accountability, for reasonableness, I'll just say A for R is to and invite relevant stakeholders.Of course, then you're then you're tasked with the question, well, who, who is relevant here?And very helpfully or somewhat not at all helpfully, I think the guidance is will anyone that will be impacted by the decision.
22:41
OK, not helpful in our sense.I mean, CAR T cell therapy involves a lot of people.I mentioned it's very complex.You know, you have to take cells from a person's body.You have to, it's called apheresis, where you you actually have a bed space as a patient.
22:58
You would go to that bed space and have your white blood cells in this case withdrawn from your arm probably at the catheter.So this is a process that needs to happen.Those cells will be extracted.So you need a local cell processing facility to extract and keep and freeze those cells.
23:17
All of this is required.It's overseen by accreditation bodies.So you need to have the trained staff to be able to do this and handle the cells appropriately.Quality is very, very important in managing in this process.So you need to have quality and auditing process and like it takes a lot actually to do this.
23:38
And then once you have the cells you can, you need to distribute it to the manufacturer.So they need to be transported to the manufacturer in Canada.That means transporting it to a site in the United States.So we don't have a manufacturing site, apparently one that's for standard of care up and running in Canada.
23:55
So we send it to the state and then you wait four to six weeks for them to engineer the cell and then and they transport it back to us and then we keep it in our cell processing facility and then the patient comes in and we infuse the cell back into the patient.So this is just to illustrate that it's a very, it's a very complex process.
24:14
There's a lot of people involved.There's cell coordinators, there's nurses, there's obviously the oncologist, there's patients, there's their family members, there's, you know, bioethicists, there was myself, there's leadership that overseas a lot of this part T cell therapy, I should also mention can touch other areas of the hospital.
24:34
So again, some of the side effects of part T cell therapy can be severe.So some of these patients might experience cytokine release syndrome, which is like an influx of your immune cells sort of sort of exploding in your body, going haywire as a result.
24:51
And it needs to be managed and it's very severe.You can develop neurotoxicities based on this.It can be very harmful and it's best managed in an ICU by very trained staff that know how to manage this.So, so now you can see right there, there's other people that are impacted by CAR T cells.
25:11
So bringing in potentially the viewpoints and considerations of the ICU of our chemotherapy units, of our apheresis unit.So there was a lot of people to consider in this case to bring together and we did have quite a large working group when we began this project of about 35 people.
25:30
That's too many cooks in the kitchen.Not all of them came all at once, but to get the point about utilitarianism, I didn't forget it right there.There's I mean, there's so many people and but there's a lot of difference of opinion then about how exactly this, how do you define and understand benefit in this patient population?
25:52
And we have lots of discussions around who would be most likely to benefit from CAR T cell therapy.And this was where I found it very interesting as a non medical person because the discussion came out around, well, you know, someone is someone who has greater disease progression may have a greater chance of benefit of CAR T cell therapy because their disease is progressing.
26:18
It's their last line.They really need this.It's their only option.And the disease is, it is advanced, so they have a greater opportunity to benefit because there's no other options for them and they can't wait very long because their disease is progressing.But then others would say, well, if their disease is progressing, then they may actually not do so well with this therapy.
26:39
It may be too far gone or they may be too sick, or they may have other comorbidities.So we should be allocating this to someone who is sort of less sick in that sense they they could derive more benefit from this.What strikes me about the case, the problem that you're working is that the same analysis and the same issues come up whenever we're talking about scarce resources.
27:03
And so we could be talking about ventilators during Kovid, we could be talking about solid organ transplantation, we could be talking about something as simple as diabetes medication, right?So whenever there's a scarcity of resources, which there always is some sort of scarcity, some sort of limitation, then we have to make really hard decisions about who gets what.
27:23
And there's a letter of different ways of approaching it.And I think people who aren't familiar with these types of cases mistakenly assume that it's fairly simple that we just, you know, list people and they've got criteria and then we, whoever deserves it, whatever that means, gets that organ or that medication or that resource or whatever.
27:44
But it's so it's so much more complicated and nuanced.And when I'm teaching students about allocation of scarce resources, if there's almost always a point when they start going through the problem set or the the case and then they have to stop and be like, wait a second, this is way more complicated than I Then then we started thinking this was.
28:02
So I think that's part of the benefit of having an ethicist in the room is like, we anticipate complexity probably better than most people.But yeah, it sounds like you're struggling with the same thing.And if it's not immediately complex, we can show how it is.Yeah, We're good at making it seem really complex.
28:19
It immediately kind of like struck me as like very similar to organ donation.But I think Tyler's right that a lot of scarce resources like this.But I think what I am struggling with is not that it's easy with organ donation, but we do have some sense of we've been doing organ donation long enough where we can sense like if somebody is too far gone to receive the benefit of the organ.
28:40
But with COVID, it was really unclear.Like we were using tools to help us understand, like how people, how close people were to death such that maybe treatment wouldn't help them.But we were really unclear about it because COVID was so new.It was such a novel disease that we were really unsure if our tools and our measurements were correct.
29:02
So is is this therapy somewhere in between there, like we have some evidence of its effectiveness for certain populations depending on disease progression?Or is it more like COVID where it's just so brand new that we're not certain of our own measurements?So I would say that it's more leaning towards the COVID scenario and obviously not entirely.
29:21
A lot of the studies that the approvals have been based upon the FDA, Health Canada, European nations have based approvals on our early phase trials.So phase one, phase two trials.The long term effects of this therapy in this in these populations is, is not well known.
29:42
We're starting to know a little bit more, but it's there's a lot of uncertainty.There's also a lot of uncertainty around predicting which patients will do well exactly.So there's a lot of medical uncertainty.They have scales.Frailty is seen as maybe a significant factor in considering whether someone will do well comorbidities.
30:00
But I've witnessed my medical colleagues struggle with this around making predictions or knowing or having knowledge about which patients will do better.And a lot of their research in this space, or not a lot, but a stream of research in this space is about trying to figure out which patients will do better on this therapy than others.
30:21
That makes the ethics really complex too, because if you don't have good facts about who's going to benefit, then you really need some other.I see now why you're saying utilitarianism can't work here because we just don't have enough facts about outcomes, so we need some other kind of model.And I might touch on one criteria that came up because it was interesting discussion in our group and it's come up in other allocation decisions before and that is age.
30:46
So did you allocate a scarce resource based on age?And this came up in our discussion as well.And you know, to the to the point about not having all the facts, there isn't much research to show that age is predictive or correlated with outcomes in car T cell therapy.
31:08
There isn't good rationale for leaning on age as a determining factor or criterion to consider in allocating patients.So in our working group, we had a lot of discussion and patients were included in our working group and they were very adamant that age should not be a criterion if we cannot justify it based on sound evidence, medical evidence.
31:35
And we had disagreement about whether we actually had that sound medical evidence.And in the end, we as a group decided we did not.So age was excluded from our list of factors to consider when prioritizing patients.And I know that age is a very contentious factor in discussions of other resource allocation discussions.
31:55
Yeah, because age can either age as a criterion doesn't tell us whether being older is an advantage or being younger is an advantage.And also it's interesting.I think it's important that you tried to link your decision about whether or not age is a criteria to evidence, because a lot of evidence is based upon all evidence is based upon research and the research is based upon protocols.
32:19
And there are exclusion criteria, probably based upon age, in the underlying research as well, which also complicates it.Yeah, but can't we say like a 99 year old?OK, maybe it will or won't work for them, but gosh, how many years did they have left if they get therapy or not?
32:35
I mean, they're, I wouldn't say that, of course I love old people.But I have heard people say that like, you know, even if we don't have evidence that it'll help or hurt based on age, just by nature of like human lifespan, if we're giving therapy scarce resources to people who are very, very old, they just won't derive the same benefit as somebody who's very young.
32:53
The general population feels that way.But I agree with you that it shouldn't be good criteria.Yeah.And especially in the context of Car T, when people are this sick, if you take a 45 year old person who's that end of line cancer treatment, this is their last sort of shot, but they have a whole host of comorbidities associated with their illness.
33:16
Very they have a not good medical gestalt here is they could be harmed by CAR T and actually not derive any benefit versus obviously a 99 year old who's very, very fit and otherwise healthy.
33:33
I mean, this is a very a little bit far fetched scenario, but I mean, you will see quite a significant age difference in some of the candidates.And I think the rationale is that it needs to be based on the underlying condition.I mean, we're all going to die, but there's certain things about, you know, frailty or having other conditions that make us more vulnerable to, to not doing so well other than relying on age.
33:58
Because if you rely on age to differentiate the 99 year old, then you're going to have to rely on that threshold to make differences of other age groups as well.And I'm not sure that that would stand up.Yeah.So making a choice between a 99 year old and a 19 year old may be easy, but making a choice between a 55 year old and a 65 year old, I mean, that's where it really gets into something more problematic if you don't have clear justification for it.
34:22
And I'd say the other interesting very contentious area that we engaged our working group in discussion about and had very heated discussion about was psychosocial factors.And this comes up in organ transplant as well.CAR T cell therapy, it's infused in hospital, but it requires a lot of a caregiver.
34:42
So patients it's, I believe it's actually mandatory to have a caregiver to be eligible for CAR T.So we might worry about those patients obviously who lack, who are more isolated, who don't have a caregiver, maybe don't have the financial means to hire somebody to care for them while they're going through Car T and then the time spent at home monitoring their symptoms for many days afterwards.
35:07
A caregiver is very essential for good outcomes for CAR T, good medical outcomes for CAR T So we had a discussion around, well, what would happen if a patient didn't have a caregiver?Should they then be excluded from parting a slot?And our overwhelming consensus from our group was this should not be an exclusionary criterion.
35:28
Lacking a caregiver shouldn't mean that you don't have access to CAR T Rather what it should mean is signal that we need a lot of social support around this person and to find ways to enable them to have the the caregiving support or some social resources to enable them to get there.
35:47
You know, you have to have a very well resourced center with social work with in our case, we also have some philanthropic funding to be able to house patients in a hotel or some supports.Or we had an agreement with another care center that enabled some of our very unstably housed patients to go to receive aftercare of Car T so they could have that follow up care.
36:13
So it was a signal in our process to identify patients who lacked a caregiver, not to exclude them, but to then wrap around support for them.But this is similar for for transplant as well.As I understand it's that there needs to be some demonstration of a caregiver and obviously that's tied to socioeconomic status and other.
36:32
I'm really glad you made that decision.I'm like really heartened by the, the justice framework that you're using here.But it also required a lot of, like you said, supports from the health system that you work in.All right, So you've gotten together the stakeholders, you've thought about criteria.What's the next step then?
36:48
I mean, the bulk of this process is engagement and discussion really.So you're bringing together all these differing viewpoints, these differing values considerations.You're finding areas of overlap and trying to signal to people as an emphasis, as a facilitator of this process, finding ways that people are actually speaking the same language, even though they may seem at first to be in disagreement.
37:17
They're you're asking questions to elaborate on certain reasons why certain people think that aid should or should not be a factor.Or can you tell me why?So the process of actually getting people together to identify what are relevant criteria for the decision was the bulk of the engagement and it took place.
37:38
We were, we were interrupted by COVID.So there was.Like we all were.And COVID put other other pressures as it did for everything, other pressures on the car T cell process.You know, we had a lot of exodus of healthcare workers.We had bed space that was reallocated.
37:56
You know, there are drugs that we use in car T cell therapy that were then used actually for COVID, the viral vectors.So the thing the the thing that helps the engineered cell go back into the cell when it's when the white blood cells are taken from the patient and engineered at the manufacturing facility, they engineer the T cell and reinfuse them.
38:18
They use a viral vector to get that, to get the car T reinfused into the cell.Those viral vectors were being used in the COVID vaccine.They were also being used in other gene therapies.And there was actually a shortage during COVID for that.So there there was pressure.
38:36
You know, I'm in Canada, it's a publicly funded health system.We have scarcity based on just finite resources.But there was also this manufacturing limitation that hit the globe for car T US included.Everyone was hit by this viral vector shortage because of COVID.So there were many ways that COVID interrupted our process.
38:53
So when when you were developing your process, you didn't put in a contingency plan for a global pandemic that creates resource scarcity across the entire globe?You will in the future, I'm sure.Seems short sighted.We are all learning to incorporate the unexpected.
39:09
But I think that also highlights the like the contingent nature of a lot of ethics clip clinical ethics work, right?And so it's very uncommon, I think for a really competent, excellent clinical ethicists to say, this is the right thing, right?This is our process, this is how we're going to do things.
39:26
It's morally the case of here, here's a couple of options.And if this, then this is what we should do, right?And if this happens, then this is what we should do.And even in our policies and processes, we we get that if then type of approach.I think that that's common for really good clinical ethics is to be able to identify what are the ifs and what are the thens of what we're dealing with.
39:49
Although the global pandemic may be threw a sulfur a loop.And I think also another thing I said before that I studied philosophy when when I was doing my degrees, the other thing that I've struggled with in actually teaching other ethicists to do this strange job that we do.
40:07
Is that you can never apply theory in the way that theory intended.You know, it's this is messy real world.And that may seem obvious to many people, but when you're an idealist and you've studied some of these theories, you know, it's a little bit hard to accept.
40:25
I think when you come in, you know, out the other end and you're actually practicing ethics in, in the clinical space.So I, I would be the last one to say that, you know, we followed this process.They for our accountability for reasonableness to a perfect TI think that there there is always a, a good, you know, pause for reflection about what we could do better.
40:47
So for example, I think the discussion that we had and the, the people we involved in the discussion was very strong.We involved patients, We did a separate focus groups with patients.I think that they were engaged actually very well and their thoughts were heard on many points, not just the age criterion, but there were, there were other points that they made.
41:07
Adherence was once a criterion for patient prioritization.If a patient was seen as unlikely to adhere to the to the protocol of CAR T, which again is is very comprehensive, they have to commit to a lot of appointments and following, you know, drug regimes and so on and so forth.
41:26
Early on that was thought to be a factor.Patients vetoed that almost immediately.Adherence should not be a reason to exclude anyone from CAR T.They emphasize that we need to look at the reason for non adherence.You know, is it the case because a mother of three children can't actually attend her appointments because she's got competing childcare demands and can't make it to the center because she lacks a car?
41:51
Yes, we ought to attend to those complexities of this particular patient's experience.So adherence was actually one of those things that was thrown out very early on and that was because primarily of the patient voice.So Jen, I love hearing about all the particularities of what the group came to, and I just wonder how you think about your role and the success of what you're doing from the ethics perspective.
42:17
I hope that this story is is a successful example of an embedded ethicist facilitating a process that was engaging for everyone and that helped to develop a transparent and hopefully fair framework for allocating a scarce resource.
42:41
I think the benefit of having a bioethicist involved here is that, you know, I, I don't think of myself as a neutral third party.I have my own perspectives and values and beliefs as an ethicist.I come from a philosophical paradigm.
42:58
I come from a feminist philosophical paradigm.I mean, I have, I have to do work of reflexivity as well in my practice, in my ethics practice.But you know, I do think that there is a stance that I can take by offering a tool, which is accountability for reasonableness in this case, to a clinical team that was struggling with a decision, where they were not only struggling with a decision, they wanted to do the right thing, but they're also mired in their own power hierarchies of medical power hierarchies.
43:33
They needed somebody to be able to come in and level the playing field in a sense, to say, well, that coordinator's voice, that patient's voice is just as important as the medical director's voice.And kudos to the medical director for bringing me in and being open to the process because, you know, the practice of ethics is really reliant for good or I'll, I think on relationships that can place us in difficult situations sometimes.
44:05
But a for R is a, again, a process where you're not asserting a certain position upfront.You're really trying to come to compromises, and again, that may be coming to decisions that the group has thought is justified, where you as an individual may still have reservations.
44:26
But hopefully through dialogue and an empowered engagement, you can reach a solution that people can say it's OK, we understand, even though we may not fully agree, we understand.And I think an ethicist is just very crucial and important in that process.
44:44
Jen, I think that your your institution is very lucky to have you there and also it is wise in using your skills to help benefit this process.It So what what you're talking about reminds me of something that my my mentor at UCLA, Doctor Hines, said, that a good clinical ethicist is able to help people find their moral voice, but then also be able to hear the moral voice of other people.
45:08
Yeah, that's lovely.I, I, I love that.I might use that.Yeah, feel, he loves it when I steal his stuff, so feel free to use it.So, Jen, thank you so much for sharing that story.I think resource allocation is one of those topics where we sort of talked about it before COVID, but man, it has become just an obviously really important discussion and it sounds like you came up with a really great framework for working through it at your center.
45:34
Yeah.Thanks so much for the opportunity.It was quite painless to do this so.That's what we like.That's going to be a new tagline.Quite painless.Thanks for listening to this episode of Bioethics for the People.We can't do it alone.Thanks to Christopher Wright for writing and producing our theme song.
45:52
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