Willowbrook State School

Bioethics for the People

Devan and Tyler explore the Willowbrook State School, that stands as a stark symbol of the dark chapters in the history of medical ethics and public health. Willowbrook gained infamy for its association with highly controversial medical experiments conducted on children with intellectual disabilities during the mid-20th century. Led by Dr. Saul Krugman, the Willowbrook studies became emblematic of ethical questions about the treatment of vulnerable populations and the boundaries of medical research.

• “Willowbrook: The Last Disgrace” Investigative Report by Geraldo Rivera

• DuBois, J. M. (2008). A framework for analyzing ethics cases. Ethics in Mental Health Research, 45-57.

• Krugman, S. (1986). The Willowbrook Hepatitis Studies Revisited: Ethical Aspects, Reviews of Infectious Diseases, 8:1.

Transcript

0:03

Come to another episode of Bioethics for the People.I'm joined by my Co host Doctor Devin Stahl, who according to her student reviews should be cloned and teach all of the bioethics.And he's Tyler Gibb, who, according to his students, is best described as the goat of bioethics.

0:28

Devin, it's my turn for a case.All right, can't wait.This case is really challenging, I think, but more so because it's like, emotionally provocative.OK, not, not that any of our cases this season haven't been emotionally provocative, but this one is, I think, particularly challenging.

0:49

OK, that's that's a lot to say because we've had a lot of tough cases this season.But this is also one that I think is probably one of the more commonly taught in kind of introduction to bioethics courses.And I know that you teach it quite a bit and I've taught it quite a bit too.So yeah, I'm happy to get into it.

1:06

So it's the case of Willowbrook.Yes, Willowbrook, this is a good one.So you've heard of Willowbrook?Of course.OK.So I'm going to kind of paint the picture of Willowbrook as an institution and kind of the history and kind of the dark, the dark past that came out over the the decades that it it operated.

1:29

But then, But then there's some interesting bioethical wrinkles and and issues that we'll get into at the end, OK?OK.All right, so the Willowbrook School was created in 1938.Ish.So it's in New York.It's on Staten Island.It was an institute that was paid for and organized and and run by the state of New York, OK.

1:52

And it was created at at a time when there was this outcry or this public interest.Or maybe it was even just a kind of a public perception that people who had mental disabilities or developmental disabilities that the best way to care for them would be to institutionalized them.

2:12

So put them all in some sort of group setting and care for them all at the same time and and all in kind of the same way.So this institutionalization kind of movement went through was all over the United States.Many, many states across the country had multiple state institutions.

2:30

Actually, here in Kalamazoo in Michigan, there's a a state institution for the developmentally disabled folks.But now it's just a state public psychiatric hospital.I bet they called it something that we would never call it.Today, yes, yes.Which doesn't even need to be said right and I.

2:46

So I think it's it's important the outset that we're going to be using terminology and language from some of the historical descriptions and accounts and stuff.That's language that you would never use, I would never use in my day-to-day life.And so I just want to put that caveat that some of the language is kind of rough and can be pretty triggering.

3:04

And also we're going to talk about children, disabled folks who are being treated in really terrible ways.So just want to put that out at the beginning.So during World War 2 this institution that was created in Staten Island had actually been taken over by the military and was a large army hospital operating in Staten Island during most of World War 2 and then kind of towards few years after the World War 2 and they did all types of the surgeries and orthopedics there a lot of kind of General Hospital medical care for veterans and and people who had served in World War 2 and subsequently.

3:46

So at some at one point they had 2500 ish, 2025 hundred is soldiers, veterans being treated on a regular basis at this hospital.Wow, okay, so large, many buildings, many different wings of these.

4:04

It was built to house about 4000 patients or 4000 people.So it's a large institution, sprawling, supposed to be very picturesque.And actually it's it's had been taken over by a State University, the State University system in New York and so it's now being re appropriated for something else, but it's a vast campus what we'll call it so.

4:25

That's typical, right?So from what I understand of the institutionalization process, there was this idea that being part of the land, being able to work the land and teaching people how to work the land and get and being physical was part of the rehabilitation process.

4:43

So for some of the institutions, it was teaching folks like how to earn a living on their own.The idea was that they would come and get educated and then they could go back into their communities.And so you'd needed a space where that could happen.So it was a kind of very idyllic setting for these institutions.

5:00

Not always, but it sounds like for this one, that's true.Right.So the setting was very much part of like the the the ethos of the institution like like you said job training ideally education.So there's a school component to it.And so it was a place where families who had children who they couldn't take care of for a number of reasons.

5:20

Maybe it was just physical disability like we give it a severe case of like a a severe case of cerebral palsy or spina bifida or something like that's very physically debilitating and and many families and communities struggle to provide adequate resources for for folks like that.

5:39

And so being able to have a safe place for families to kind of entrust their loved ones was a really important part of how they were trying to love and care for their patients.And Willowbrook was described and advertised as a very idyllic situation.

5:56

They had all the resources, they had facilities, they had experts.And so families were eager.And there's actually a waiting list to get people into this institution.And so it was really well marketed.At first, isn't that how bad stories always start?That's.Right.There's this glossy, you know, it's before the days of like a glossy brochure.

6:15

But you can imagine that as like, you know a glossy brochure of send send your children.And.And I think it's important to say at the very beginning that families entrusted their loved ones to this institution out of really good intentions and out of love.

6:30

And unfortunately, the funding from the state was never consistent and never as much as it needed to be.And over time, there got to be overcrowding and the constriction of resources.And eventually, over a number of years, decades, it, it developed into a place that was really, really different from the living conditions that these families hoped that they were entrusting people, their loved ones into.

6:59

Yeah, and.And people didn't tend to visit a lot, right?So maybe it wasn't obvious that things were getting worse and worse if you if if it was far away from where you lived and you didn't have the opportunity to go and visit very often.Exactly.And some of the the visitations especially when people of leadership in the state or politicians or whatever, whenever they would come to visit these announced visits, they did a really good job of cleaning up the facility and and making it look like things were as they should be and not not showing actually what the the day-to-day life living situations were.

7:34

And so, like I said earlier, families were eager and looked forward to and advocated to get their children into this institution because they thought it was the best place for them.Yes.And this is where I think it's important to paint the best of intentions of families, because I think it's easy to look back and say, you know, people were just dumping their children off, that they didn't care about their children.

7:55

That might be true of some people, but I don't think it was true for the vast majority of people.Yeah.And it I think it would be wrong for us to assume that that was the intention of most of the folks who who ended up there as well and even the people who worked there and maybe even did some of these things or allowed some of these conditions to continue like it's it's hard for me to assume malice, right.

8:18

So I don't think that these were necessarily evil people, although some of the decisions that were made are pretty hard to hard to justify.So the institution is running in the late 40s, in the 1950s and the 1960s and the 1970s and as a military hospital it had a really good reputation.

8:36

It was kind of like the Walter Reed of that region where families and veterans they would seek out care there.And over the course of the as it transitioned into a long term care facility for developmentally and physically disabled individuals, children specifically, the reputation definitely changed.

8:55

And there there were reports and rumors and allegations of mistreatment and neglect and and stuff that started percolating and started building up to the point that one of the state senators did an unannounced visit to this institution in the mid 1960s.

9:15

So quick question, Devin, who is your favorite Kennedy?Robert, of course.Which, oh, good, Robert.That's my favorite as well.So Robert F Kennedy, brother to to John F Kennedy.

9:32

So this was, yeah, he was a state senator at the time.He went on to obviously be the attorney general and the nominee for the president for his unfortunate assassination.So he went and visited Willowbrook and took along reporters and kind of his aides and his whole entourage, and they did an unannounced visit.

9:53

And he came away, I would say, shocked and horrified at what he saw.So I'm going to play a brief video clip of him recounting that, OK?I visited the State institution for the Mentally retarded and I think that particularly at Willowbrook, that we have a situation that borders on a stake pet and that the children live in Bill.

10:18

That many of our fellow citizens are suffering tremendously because lack of attention, lack of imagination, lack of adequate manpower, with very little future for the children or for those who are in these institutions.Both need a tremendous overhauling.

10:34

I'm not saying that those who are the attendants there or the ones that run the institution are at fault.I think all of us are at fault.And I think it's just long overdue that something be done about it.Who has that accent anymore?It's just such a perfectly Kennedy accent accent.

10:51

Yeah, I don't know anybody who speaks like that.Maybe maybe if we lived in Massachusetts or you know, someplace in New England we would hear that more often.But it is such an iconically Kennedy like phraseology and accent.But anyway, so a snake pit, right?And and again, let's just, let's just keep in mind that these are children, right?

11:10

And not just These are children who are particularly vulnerable to mistreatment because they're they're disabled children, right?Yeah, so horrifying.So he was horrified.Horrifying.We should be, we should be horrified.

11:25

We'll we'll post, I'm sure, links to some of the documentaries that are horrifying.Yeah.Yeah.And so his quote is living in filth and dirt and their clothes in rags and in rooms less comfortable and cheerful than the cages in which we put animals in a zoo.

11:42

And so after this he takes us on his one, his one of his primary causes as a, as a, as a politician, as a representative of the people and makes a lot of, I would say makes a lot of noise about this.

11:58

But and and there's some agreements between the state and the institution and the parents about improving conditions and and getting adequate resources.But it didn't actually change much over the subsequent several years.Yeah, Robert Kennedy dies and not too many years later and has moved on to different political offices.

12:19

And so the issue kind of it came to the spotlight for a moment, but then it there wasn't really staying power.And part of that I think is because it was him recounting what he saw, right.There were some photos that were distributed in in the media, but he wasn't able to really, I would say really make the case or make this tell the story in a way that had as much impact as it needed to.

12:46

And the Kennedys have always been big proponents of disability rights, so this sort of falls in line with kind of the whole Kennedy ethos around this.So it's interesting, but and interesting that it didn't win people over in the way you would have expected.Yeah.And I don't know enough about that kind of that moment in the history about what did did Kennedy after he kind of took this on and saw this issue did he you know what what the timeline was before him going into national office and maybe it kind of fell off of the the radar to a certain degree.

13:16

But in let's Fast forward a couple of years to 1972.OK.So there's an investigative journalist who meets with who would we would describe as a whistleblower now a whistleblower who worked at the the Willowbrook school and this was a healthcare provider and he was horrified, disgusted, outraged at the condition of these children.

13:41

And he had tried to go through the the Gen. the normal routes avenues of advocating for the patients and making noise internally into the in the institution advocating for change, but was ultimately unsuccessful and left his position there.

13:57

But he kept a key to one of the buildings, and it was Geraldo Rivera and his yes, so Geraldo Rivera.So Geraldo Rivera was this investigative journalist in the 1970s in ABCS affiliate in the greater New York area.

14:16

And he went there with this stolen key.It's described in the in the the literature is a stolen key and went in through one of the back doors of the institutions with the film crew and filmed what was going on.And I think the combination of the advocacy kind of the change in the culture or between the mid 60s and the early 70s, but also having video of what was going on really struck a nerve with culturally.

14:49

Yeah, it was a moment and I'm sure the video helped.If you've seen the video, it is horrifying.It it it's one of the more troubling videos that that I've seen.So I'm just going to play a clip of him.So this is Geraldo Rivera introducing his the the news piece that he created.

15:07

It's been more than six years since Robert Kennedy walked out of one of the wards here at Willowbrook and told newsmen of the horror he'd seen inside.He pleaded then for an overhaul of a system that allowed retarded children to live in a snake pit, but that was way back in 1965, and somehow we'd all forgotten.

15:25

I first heard of this big place with the pretty sounding name because of a call I received from a member of the Willowbrook staff, a doctor, Michael Wilkins.The doctor told me he'd just been fired because he'd been urging parents with children in one of the buildings Building #6 to organize so they could more effectively demand improved conditions for their children.

15:44

The doctor invited me to see the conditions.He was talking about South, unannounced and unexpected, by the school administration.We toured building #6.The doctor had warned me that it would be bad.It was horrible.There was 1 attendant for perhaps 50 severely and profoundly retarded children, and the children lying on the floor, naked and smeared with their own feces.

16:06

They were making a pitiful sound, the kind of mournful wail that it's impossible for me to forget.This is what it looked like.This is what it sounded like.But how can I tell you about the way it smelled?It smelled of filth, it smelled of disease, and it smelled of death.

16:23

So horrific.Yes, that's the clip I always show my students.The the clip of him running across the field into the Yeah, it's it's it's tough to watch and and just seeing the images and there it's like darkened spaces and it feels like, do you remember the movie The Blair Witch Project?

16:46

So like the found video where they're like running through the forest and you can't really tell what's going on.It's bouncing around.That's what it feels like, right.It feels like a horror show.And the one of the other journalists that was with her all the Rivera started publishing, you know, after that, that the interviews that they did and the material that they gathered over the course of about six weeks, repeatedly, more and more stories almost every day.

17:11

And just kept it kept hammering and kept hammering and kept hammering.And that was the the moment in which all of the spotlight came on to Willowbrook.And eventually over there was a class action lawsuit by the parents claiming that they were their children are being neglected.

17:28

Also claiming that they were they had enrolled their students in this school, institutionalized them with under false pretenses and and they weren't being their basic needs and their basic civil rights were being violated.Yeah, hard to argue with.

17:44

Yeah.So question then.OK.Why is this a bioethics issue?Why is this a case that we all teach and that we all, we all talk about so much?Yeah.Well, I think you could probably bring up Willowbrook as a you know case study in and of itself of of related to disability in the way people with disabilities are taken care of in our healthcare system, in our education system.

18:10

What you just laid out to me is bioethics enough.But the reason that it gets taught is because a group of researchers came into Willowbrook and conducted a study on the children at Willowbrook that is hard to imagine whatever happened today.

18:29

And it's that case that that research that they did that really gets talked about in bioethics a lot.Right.So looking at this situation with the school, with the the neglect and the under resourced and these children, as many as 6000 children lived in this institution at one point at its largest, so 50% more than it was built for.

18:51

So overcrowding, really, really tough circumstances.On top of all that there was a group of researchers who were using those children as subjects for human subjects, research, experimentation.

19:08

So another random question.Devin, what's your favorite sexually transmitted disease?Cut that.Cut that right out of the podcast.All right.So hepatitis, Not my favorite.OK, OK, so.

19:23

Hepatitis during World War 2.So Willowbrooks history really is rooted in a lot of the experience of World War 2, right?So during World War 2, hepatitis was rampant.So as many as 50,000 American troops alone contracted hepatitis at some point during the war.

19:42

And so it was a big issue for the surgeon general, for the Department of Defense to like figure out what is this disease, how does it transmit like what's going on the etiology or the epidemiology of it, right.And of course, hepatitis is not just spread through sexually transmitted practices.

19:59

So did you know this is one of the most interesting, one of the interesting things that we'll talk about that we didn't know that there were two types of hepatitis.There's the one that's transmitted through like blood and fluids.That is hepatitis B.

20:16

And then there's hepatitis A, which is transmitted usually through like fecal contamination, so like dirty water.So we didn't know that that was the case until Willowbrook.Until the.Willowbrook study.I didn't know that.Wait, what's hep CI?Don't know another another version but but early in so late 1940s, early 1950s, when the researcher who's named Saul Krugman him and his team before they started their project, the 1950s, there was no differentiation in hepatitis.

20:53

Like we knew that it what it was, but we didn't know that there were different types and also we didn't know what the natural course looked like from infection all the way until death.Right.So that was that was the research project that Krugman and his team wanted to the questions that they wanted to answer, and through various personal and professional contacts, they had access to the Willowbrook School.

21:18

They knew about it, knew the conditions, and decided that this would be the ideal situation in which we can study hepatitis and figure out what's going on.Why?Why would this be the ideal place, Tyler?Well, well, that's a great question, Devin.

21:34

Why would an institution that is rampant, terribly overcrowded, rampant hygiene issues, and really difficult from a people management perspective, right?

21:53

So kidding, overcrowding, all of those issues.Why would that be an ideal situation in order to test or study the the lifespan of a disease that is transmitted through poor hygiene?Yeah.

22:08

I mean, off the top of my head, there are two reasons.The 1st is that they're probably getting it right.So like the people who reside at Willowbrook, if it's unsanitary, might be getting hepatitis.And so you know, their their population, we can isolate.And relatedly, they live in a confined space where they're easy to control.

22:29

So you can control just about every aspect of their lives because they reside in a facility and their meals are taking care of, like everything about their daily life is controlled by the environment.So in that sense, you know, they're easy to manipulate for the purposes of research because you don't, you don't have to control for a lot of other factors that you would with somebody who doesn't live in a facility.

22:53

Exactly.It's a situation in which the, the researchers have a lot of control over the variables that go that would go into the lifespan of this disease.And like you said, the infection rate for hepatitis at this institution was like unbelievable, like everybody, like 98% of people within the first six weeks got infected with hepatitis.

23:19

It's just like an unbelievable infection rate.It's it's almost like it's it's like you couldn't create a a set of circumstances in which hepatitis could be more infectious right.It's like the ideal perfect storm for hepatitis type of infections.So this is interesting because the one of the reasons or one of the rationales that the researchers put forth was these children, they're coming to this, they're being entrusted in us to give them care and they're going to get infected anyway.

23:48

So let's infect them in a way that is controllable, as predictable and maybe even we can control how much infection they get and what over what time span to help increase their immunity.Yes, which is always the thing that horrifies my students when I first say it is.

24:07

They say, well, you can't give people an infection like that, right?We don't in research give people viruses or infections or make them sick, right?I say, well, actually we do sometimes.But if you're going to do that, you have to have a pretty darn good reason to do it.

24:24

And you're going to get it anyway.I don't know if that's the really good reason that we're looking.For right.Well, it's not in and of itself a reason, although sometimes in in research ethics we talk about risk to participants being no greater than the risks they encounter in their daily lives.

24:41

And so that's kind of how you want to balance risk is you don't want to put them any participation in research, put you at some level of risk.And so the only way to justify putting people at risk is, or one of the ways to justify it is to minimize it as much as you possibly can, but also compare it to the risks they take on in their everyday lives.

25:01

And if in their everyday lives they're almost certain to get this anyway, you can see how that is a kind of justification for doing this.Right.And I think it's important, as we talk through this and and kind of talk about the ethical principles that were maybe violated or at least in question, that we keep in mind that I don't think that Saul Krugman was an evil person.

25:20

I don't think that he was intentionally inflicting hepatitis on children because he got some sort of perverse joy out of it.I think that he was a a researcher who was trying to answer a research question and he's presented with a very unique set of circumstances and he tried to do the best he could with kind of what he was presented.

25:39

Yeah.I I think it's you can disagree with what he did without painting him as some sort of like malicious figure.I I do question but I I think he had it in the if I'm going to give him the benefit of the doubt he really thought hepatitis is terrible it's hurting a lot of people.

25:57

We have a unique opportunity here to solve the hepatitis epidemic.I'm going to go for it.It's important to note also that this research project was not without criticism even at the time.It was controversial even at the time.One of the most important papers in bioethics and medical ethics is was written by Henry Beecher, right.

26:18

We talked about this in previous episodes.In 1966, this Seminole paper came out talking about human subject research and unethical research practices, and it listed, I mean he called out by name a number of different research projects that were either recent or ongoing that he would categorize as ethically problematic, and Willowbrook was one that he pointed to even in 1966.

26:43

That's right.Although he also pointed out Tuskegee, right.And that didn't that had been going on for quite a long time.Yes, he did.He did call it Tuskegee as well.Also hepatitis study.I mean, I tell you what the the US was committed to, no?That was a syphilis study.Oh, that's right, syphilis.

26:59

I I always get my STD's mixed up.These children didn't have STD's.I know, OK.I know you know.Syphilis OK, help me understand like it's easy.So it's easy to look at these studies, these cases that we talk about historically and look back at them and with our the, I've heard the term a retrospectroscope, looking back in hindsight and judging them really harshly, saying this was unethical, that person was bad, we would never do something like that today.

27:33

Is that often that's not the case right now?I don't know.Yeah.Help us think through that, Devin.Yeah, I I'm OK off the top not going to defend Willowbrook.I mean I think what happened there was unethical and I I want to get into why and I so I think, but I think actually this case and This is why I teach it is a little bit more complicated than maybe our gut reaction to it.

27:57

And so I think the details matter.Unlike something like Tuskegee, where I think wholly unethical if not evil from the get go, there is very little, really nothing in my mind to justify Tuskegee, just an evil, horrible research project that happened over the course of many decades.

28:19

Willowbrook is not quite so simply bad for I think a few reasons.And maybe we should do a whole separate episode on Tuskegee, because I think even though it's terribly problematic and and there's no way to justify it, it's worth understanding the details.

28:34

Because actually most of my students, even a lot of people I meet, do not read like they've heard of Tuskegee but they don't really know anything about it.So it's worth it's worth it's worth going through the worst cases to to know what we really have learned from them.This though, I think I teach it as actually a pretty complicated case.

28:54

How is that how you teach it as complicated?Or is it just obviously bad?No, yeah, it's it's complicated.I generally use it to talk about disability like public policy changes and how it is a catalyst to some of this the like the Americans with Disabilities Act and like all of those things.

29:11

So that's generally how it comes across in my material.But I also don't teach like an entry level bioethics class right now.But where where I would teach it more like the details of this case and some of the anecdotes and kind of the the colorful little descriptions that come out are just so emotionally evocative, right.

29:30

Like when they talk about the way in which so we we said that they intentionally administered hepatitis to children.They did.They had to eat it, right?Right.It they, they put it in their chocolate milk and fed it to him, Right.And so you hear about a contaminated chocolate milk being fed to a disabled child in an institution and like, you know, we're ready to fight somebody, right?

29:52

But I think it's important to to help us walk through the nuance of it.OK, so when I talk about with my students, here's how it it The time was justified.And actually I'm taking some of this from.We have a former professor that taught us at SLU, Jim Dubois.

30:11

He's now at Washington University and he has a really good paper on this where he's actually just talking about research ethics in general, but uses Willowbrook as a case study to think through the kind of principles of research ethics that are slightly different than clinical ethics.

30:29

And the big difference, of course, being that in clinical ethics we're always thinking about the good of the patient.But in research ethics, the primary goal is not the good of the subject.The the purpose of research is to create generalizable knowledge that can benefit society.And so we're asking individuals to take on risk to themselves for the benefit of future people.

30:48

And so we have different principles insofar as, you know, we're not really at all benefiting the individual.If we do, usually it's just by happenstance.Or if it turns out the research works.But that's we can't assume that.We can't assume that, you know, the research project's going to yield some sort of result, like a vaccine.

31:07

There's a term for that, right?It's it's the therapeutic misconception, right.And this idea that you're going into the research study and we hear this all the time with like cancer patients doing experimental, going into a research protocol should be with the intention of benefiting science, right?

31:26

If you individually benefit, that's great, but that should be the primary motivation.And if it is, there's a misconception about that.And that's where that term comes from, so.Right, right.It's really hard to get rid of that.Except people think, oh, sure, sure, sure, future people, but also maybe me.And it's hard to get rid of that.But we, we try to minimize that.

31:43

OK, so duopoly lays out four Actually 5 principles that you should consider in research ethics and how they apply to Willowbrook.The 1st is this idea of necessity.So is it necessary to infringe on the values or norms of one population for the intended goal of the future population?

32:05

So in other words, can we use these children?Can we infringe on their values and norms or or their, you know, kind of person bodily integrity, I might say, for the benefit of a of a future population.And it has been suggested that, you know, because they're children, that leaves them in a vulnerable state.

32:28

And the obvious response to that is why wouldn't they just use a population of adults?And it turns out that hepatitis is way more lethal in adults than it is in children.In fact, most children will do OK Which isn't to say children never die of hepatitis, but this particular strain of hepatitis is way riskier for adults.

32:51

And so I children are a better population, Can we infringe on, you know, the the norms of this particular population?You justify that by saying actually it's way less risky for children than adults.So in that situation, the child population of the pediatric research population is actually scientifically a IT.

33:11

There's less harm associated with doing the research in that population versus an adult population.So for that reason it it might make sense.Yeah, yeah.So the population in that sense, to use them instead of adults makes sense.So you would of course always have to justify why children and not adults because children can't give informed consent.

33:28

And so we always want to make sure that we're using adults if we can.But insofar as adults are much more likely to become seriously ill from hepatitis and children, children are actually a much safer population to do a project like this on.The second principle is effectiveness.

33:46

So this is this one's a little complicated.Like, how much evidence do we have that the research will yield positive results?So we cannot, we absolutely cannot know the future.Most research will not yield something like a vaccine.Most research fails to find or produce the thing that it intends to.

34:07

You can have a whole conversation about like the Pharmaceutical industry and why drugs cost so much, but they always say that this is part of the reason is that most of these drug trials will fail.And it's not just limited to drug research, right?This is all research.The vast majority of all science research does not right result in the outcome that was expected or anticipated or hoped for.

34:29

Right.But if it doesn't mean then that we can just say, yeah, go ahead and try.Most things fail.It's fine.You have to have really good reasons to think that the thing you're testing for will result in something positive, that it has like scientific merit to it, that you haven't jumped from, you know, theory to children, Right.

34:49

So you have to do some animal studies.You have to go through the process of the phases of human subjects research.And so you have to have a pretty good reason to think that the thing you're doing will be effective, even if you can't know that for sure.And the justification from these research researchers was, you know, they had done animal trials, they had done a few smaller population trials, but also that vaccines were booming in the 60s.

35:13

And so there was real optimism that these researchers, you know, they had the tools and vaccines were becoming so viable that this really could yield an effective vaccine.So there was great optimism about that.The third principle is proportionality.

35:29

So is the desired goal important enough to just to justify, you know, the potential risks and harms to the population you're testing on?So you wouldn't give these children hepatitis if hepatitis, you know, wasn't really a big deal, like very few people ever got it.

35:46

It wasn't really hurting anybody.You don't do it.You don't do research for the sake of research.You do it because it's a you're researching something for the public good and the risks.The more risks you put on participants, the more important that becomes.

36:03

So if you're you got to be researching something pretty darn important to infect children with hepatitis.But their rationale, like you said, is hepatitis is really bad at this time.There is a huge population dying of hepatitis A vaccine is really important and so it was justified that the proportion seems justified.

36:23

Yeah, yeah, that makes sense too.The 4th principle is least infringement.So are you doing everything you can to minimize the infringements or the the risks to the participants?And Dr. Krugman and colleagues said, you know, we're doing everything we can there, not responsible.

36:40

This is a kind of different argument.They're not responsible for cleaning up Willowbrook, right, that that's not what their job is, and they wouldn't necessarily even know how to do that as researchers, as vaccine researchers.But they were putting these children in a special wing of Willowbrook.They were cleaning up their hygiene in.

36:58

By all accounts, the children in their research wing were better off than the children in the and the rest of Willowbrook.So that's how they justified sort of minimizing risk is that these children were not in any more risk.And in fact maybe we're at less risk in their everyday lives for all sorts of things than the children who resided in Willowbrook, who were not part of the research study and they sought parental permission.

37:21

So it's of course children, and especially these children can't give informed consent, but they did seek it through their parents.I'm glad that you brought up the informed consent issue because that to me that that's one of the things that sticks in my mind is being OK.This isn't just researchers who were in a unusual situation, made questionable decisions, and maybe they compounded and resulted in this like bad situation.

37:46

It's the informed consent thing that I have a hard time getting around, OK?OK.OK.So say more.Yeah.So like I said earlier, there was this advertising campaign, this promotional effort to get people to come into the institution, right?

38:04

So there is this waiting list.Krugman and his friends at Krugman ET al.Actually used that as a a way to entice people to participate in the research, and so I was able to find an old copy of one of the original informed consent documents.

38:24

So let me send that to you.I want you to take a look at it and maybe read read it out loud and and tell us what you think about it.OK, wow, I can't believe you found this.So the date on this is November 14th, 1958 Deer, and it's blanked out.

38:41

Redacted.It redacted.Hepatitis is an illness characterized by abdominal symptoms, fever, jaundice and general malaise.It is more severe in adults than in children.It is caused by a virus spread from person to person.OK, so far so good.Very like good 8th grade, you know, reading level language in cooperation with the pediatric staff of New York University, Bellevue Medical Center.

39:04

So this was the 5th principle, just to say you have to go through the proper process.They did.They got approval to do this study.So in cooperation with the pediatric staff, we are studying the possibility of preventing epidemics of hepatitis.On a new principle, virus is introduced and gamma globulin given later to some, so that either no attack or only a mild attack of hepatitis is expected to follow.

39:28

This may give the child immunity against this disease for life.It doesn't say that I added that we should like to give to your child redacted this new form of prevention with the hope that it will afford protection.

39:44

Permission form is enclosed for your consideration if you wish to have your child given the benefit of this new preventative.Will you so signify by signing the form, having it witnessed, and returning it to me at your earliest convenience?Wow.And so the and.Yeah.And so the subtext of this is if you do this and sign this permission slip, then you will have a favorite place on the waiting list.

40:05

You'll be able to get admission.So what are your thoughts?So a couple of thoughts.This is one of the huge criticisms of this study.And I think one that is really important is that if you're on a waiting list and enrolling your child in research gets you into the facility that you've been waiting for, that sounds to me like an undue inducement, meaning you might not have enrolled your child in the study, but you got the huge benefit of getting them some other good and that probably manipulated whether or not you wanted to enroll them in the research.

40:43

So you're being, you're being pressured, you're being manipulated in some way in taking a risk or putting your child at risk in a way in which you wouldn't otherwise do, right?Right, right.You might not have said yes, but for this and in that sense, we don't want to, you know, pressures may be a good word because it's not necessarily coercing anyone.

41:03

Sometimes we use that word coercion.I think it's too strong.In many cases, something like pressure or you know, the the technical term is undue influence, which can mean a lot of things.That could mean like, if I said I'll pay you $1,000,000 to do this study, you'd be like, OK, sign me up and you probably wouldn't even read the potential risks, so maybe undo it influence.

41:24

But also like, even though it's very like straightforward in a lot of ways, it also kind of conceals what's really happening.Like it doesn't outright say we're going to feed your child this virus, at least to me it's not.I'd have to read it a couple times to get that from this.

41:42

I I don't think you would ever get that to that right.And so it says this virus is introduced right and gamma globulin given later to some.Right.It doesn't.Yeah, it doesn't necessarily.It's not clear that that means I will feed it to your child through their chocolate milk.

41:58

Right, yeah, exactly.And the the, the phrase to some causes concern, right.I mean if it's a double blinded study, I mean if there's a control group, I mean all of these questions that we would ask now about wait a second, So the gymnoglobulin is what the treatment that you think is going to be better than what's going on, but only some of those children are going to get it.

42:20

OK, so who gets it?Who doesn't get it?Like, what happens if my child is in a group that doesn't get it?Will they eventually get it?Yeah.Well, these are all questions that I'm sure are addressed in the appendix that comes with this letter.No, that's not the case.

42:39

Yeah.And so I think so informed consent, the vulnerability of the patients, the the, the situation at Willowbrook, how it was really, really terrible, horrific at the time that this research project was going on.

42:56

Like all of these things kind of coalesce into this perfect storm of this.The things things did not go right in this situation.So what Dubois.And actually, I think I, I don't think I definitely agree with him.Well, let me so back up a second.When I do this case with my students, they can actually usually come to those five prima facie principles.

43:17

And so we chart it.I have them do this sort of mind map where they're they're trying to connect these facts with values and and whether or not this is a ethical research or not.And they'll have a lot of lines actually that go toward yes, this is ethical.

43:33

In fact, more lines that say this is ethical and they'll only have a couple of lines that go toward the idea that this is unethical.And the two lines are, you know, the what we just said about the informed consent being not great.The 2nd is this idea of vulnerability.

43:51

It's triple vulnerability.Their children, children are more vulnerable.They're disabled.So it's the intellectual disabilities make people more vulnerable to certain kinds of research and they're institutionalized.So that's that's three kinds of vulnerability.

44:08

And so you can't imagine really I can't imagine a more vulnerable population than the children at Willowbrook.And so to choose them needs a huge justification and to my mind the only way today.So this is pre common role which is the the current federal regulations that tell us about ethics and research and it talks about vulnerability in particular.

44:32

So today we would say the only way to justify doing any research on that population would be that they are really singularly the only population having the problem being researched and that the benefits would only accrue to them.That is definitely not the case.

44:47

We have a huge population that can serve as potential subjects because it's a huge general population that can get hepatitis.So they're not singular.And they're they might be singular and like, that's the perfect storm to get hepatitis, but they're not the only ones who can.

45:03

And so it's you can't justify using them, this extremely vulnerable population, to accrue benefits to a much larger population that includes them.But it's not singularly them.And that's, to me, the only way you could plausibly do this research.

45:19

And I think that's hard for people who kind of don't get into the weeds about research ethics to to to start to wrap your head around is like there are situations in which this population in this setting can can not only participate but be the beneficiaries of research.

45:40

But this just wasn't the case, right?This wasn't this.This was more a situation where this population was chosen because of convenience and not because of this is the the science was driving the selection of this population.Yeah, I I think ultimately you can say that.

45:56

And so it's not quite as clear as like this was the he was just, you know, trying to prey on this vulnerable population because he could and it was mere convenience.He had other reasons, but ultimately I don't think those reasons were good enough to use this population.Krugman went to his, his, his coffin, his deathbed, arguing that he did nothing wrong and that they followed all of the the ethical principles, and it was justifiable.

46:17

And there were notably, notably good, quote UN quote, good outcomes, I guess.So we talked about earlier the the actual science, the understanding of the Physiology, the pathophysiology, and the process of the disease itself.

46:34

We learned a lot from Willowbrook.Yeah, well, they came up with a vaccine, right?So, you know, they they were able to do the thing that they set out to do, which is in itself incredible.It doesn't post facto justify what they did to the subjects.Yeah, we, we, we get this question a lot when we start talking about some of the research experiments that were done, quote UN quote research experiments, the human experimentation done during World War 2 by Nazi doctors and and you know, physicians in other parts of other countries as well.

47:07

There are some things that science has learned from those studies, but that doesn't retrospectively justify what happened to those people, right?And we can still, not even, we can still use that scientific knowledge to continue kind of the our understanding of of humans and science and and medicine without also having to accept the way in which we got that information right.

47:29

Is that how you approach that?I, you know, I actually leave it up to my students to decide because I'm, I think there's still maybe good reasons to throw it out, even if it can save lives.I mean, like, apparently every almost everything we know about hypothermia was done by the Nazis in the most terrible ways.

47:48

And it's still the kind of not the only knowledge we have because you just can't, like, let somebody almost die from hypothermia like, as part of your research anymore.And so it's really hard to replicate those studies in an ethical way.But I I think it's, for me still kind of, I feel pretty conflicted.

48:03

We would say today, if it turns out that your research was not done in an ethical way, it will not be published or it will be retracted.And so we do actually take away that knowledge in some ways.So if you were to do any of that stuff today, we wouldn't use it.So why is it OK that we, you know, the the Holocaust wasn't that long ago.

48:22

You know, what the Nazis were doing, The Nuremberg trials were not that long ago.Where do you draw the line?I think is for me still.I still am pretty conflicted about it.I thought I had a good answer to this until we we hear it.At my school we hosted a woman who was one of the last surviving last survivors of Mangalas, actually her the twin medical experimentation.

48:47

So she was one of the twins and so she came and visited and and she really powerful woman it talked about her experience and and so she she was in I can't remember it was Auschwitzer Dachau but she was one of the concentration camps she like interacted with Mangala she had a twin sister who received different treatment like experimentation than she did And and so she talked about this experience and I was sitting next to a woman who was in our department who has who is Jewish by background and bioethicists really well read really insightful I after after the media after the the lecture.

49:23

I asked Eva Moses core who is the woman who was visiting one of the maybe it was one of the the audience member asked her this question like what do we do with this knowledge that came and her response was if we don't do something with that information that came out of these experimentations then we're dishonouring the legacy of people who who had to go through that right.

49:43

And it was very very much in the in the spirit of like forgiveness and moving forward and reconciliation.And I was sitting next to this other woman and she leaned over and she said, I completely, really disagree with that.She said it has to be the only way to honor those people is to suppress it and to not like build upon that foundation.

50:00

And so I was like, gosh, I mean these two really eloquent, smart, like the invested people coming to very different conclusions for kind of the same reasons.I was like, I don't know this, this is.This is why ethics is so interesting and so hard and so complicated and changing, I guess.

50:17

And that's why we love this field is because there aren't easy answers.Yes.In fact, there are no easy answers.Trademark.OK, So yeah, that's Willowbrook.What else?Anything else that we missed?You know any Nuggets or tidbits that you impart upon your students when you're covering Willowbrook?

50:37

No, I mean, I think what I want my students to really get out of the exercise of going through is to say there might be 20 plausible reasons why something like this is ethical, and only really one or two reasons why it's unethical.But those reasons are so strong that they outweigh all of the other reasons.

50:55

And that's OK.So it's good to dissect the case.It's good to think through the ethics of it.At the end of the day, there might just be 1 ethical principle that it is too weighty it it weighs it outweighs all the other justifications and and that's OK and that's some that's why I teach the case.

51:12

I mean there are actually a lot of reasons I teach the case because I also do disability rights and disability history.So it's important this is an important moment there but it's also to show my students that it's on balance.You don't have to say, oh, there are six reasons why this is ethical, 7 reasons why it's unethical.So therefore you know, one with no some principles are more weighty than other principles.

51:32

Yeah.And that gets into the even bigger questions of how do we weigh different ethical principles against each other, Right.And so, yeah, that's some of the Gray area that we love in bioethics, so.Yes, we do.All right.Thanks, Tyler.That's a good one.Thanks for listening to this episode of Bioethics for the People.

51:48

We can't do this podcast by ourselves.We've tried and it's not pretty.Our team includes our research interns, Michaela Kim, Madison Foley and Macy Hutto.Special thanks to Helen Webster for social media and production support.Our theme music was created and performed by the talented Chris Wright, friend to all, dad to two, and husband to one.

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Podcast art was created by Darian Goldenstall.You can find more of her work at dariangoldenstall.com.You can find more information about this episode and all of our previous seasons at bioethicsforthepeople.com.We love to connect with our listeners.All of our episodes can be found wherever you listen to podcasts.

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