Evidence and Ethics in Healthcare Research with Dr. Zeke Emanuel

Transcript Generated by AI.

Announcer: 0:00

Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts hosted by cardiologist and top medical researcher, Dr. Michael Koren.

Dr. Michael Koren: 0:11

Hello, I'm Dr. Michael Koren, the executive editor of MedEvidence, and I have a really super fun task today to introduce my friend, long-standing colleague and an incredible doctor, Ezekiel Emanuel. Zeke Thanks for being part of the MedEvidence family now. And Zeke has had an absolutely storied career in medicine that goes way back to when we were in medical school together. I'm going to tell you an anecdote in a second about that, but Zeke is the chair of bioethics and health policy at the University of Pennsylvania. He's been advisor to the White House, to the WHO, and he's widely considered as a true thought leader in the areas of bioethics and also in public policy. So again, Zeke, welcome to MedEvidence and I'm really looking forward to our conversation.

Dr. Ezekiel Emanuel: 0:59

It's great to be here. Thanks for inviting me.

Dr. Michael Koren: 1:02

All right. So I'm going to start off on this anecdote that I just shared with you, to remind you, because I think it's really wonderful. So Zeke and I were actually in the same medical school class at Harvard and we both chose the curriculum that involved a more rigorous scientific part of medicine that was run through MIT, and so there's probably about 25 of us in that program, something like that. So I was late to go to school because of a family emergency and I show up to one of the first sessions where we're getting oriented to the other members of the class. I don't really know who anybody was at that point and there was a professor that was going around trying to predict what our specialty would be, literally as first week medical students. And again, this is what the professors did for fun. I guess they wanted to see if you had the personality of a pediatrician or an obstetrician or a surgeon or somebody in a non-patient care specialty like radiology. So they went through the whole group and people raising their hand yeah, I want to be a surgeon, I think I want to be a pediatrician, I want to do OBGYN.

Dr. Michael Koren: 2:03

But Zeke didn't raise his hand. So eventually the professor comes over to Zeke. He says I noticed, Zeke, you haven't raised your hand. Do you know what you want to be? And he says I want to be a medical bioethicist. And the whole class smiled and I didn't know him. This was literally the first time I heard anything come out of Zeke's mouth, but it so impressed me that you knew exactly what you wanted to do. And it also fascinated me because I had no idea what a medical bioethicist is. And in fact you did exactly what you said you were going to do, which is so impressive and really part of our mission here at MedEvidence is to help physicians understand career paths and how people get to certain places. And, given your great success, I think the audience will be super interested in us understanding how you went from that statement in the first week of our medical school class to where you are now as a chairman of a major department at a great academic medical center. So tell us the story, Zeke. I'm super fascinated.

Dr. Ezekiel Emanuel: 3:00

Well, I did. I was an undergraduate at Amherst College.

Dr. Michael Koren: 3:06

Great school.

Dr. Ezekiel Emanuel: 3:07

Double majored in chemistry and philosophy and very interested at that time in ethics and political philosophy, and I was also, you know, pre-med. But I really didn't want to go to med school. On the other hand, as I like to say, being a doctor was sort of overdetermined. My father's an immigrant. My father was a pediatrician. I was the eldest of an immigrant pediatrician and I was very good at science and it's like there's no alternative. You got you know he was pushing medicine, but I was very hesitant.

Dr. Ezekiel Emanuel: 3:50

I had worked a few summers in labs. I found the science interesting, but I didn't find spending my time in the lab interesting. So I applied to med school but I went to England to work in a lab there for a couple of years to see if I really liked it, and it was actually pretty good. I did molecular immunology. I got three papers, including one in nature, done we identified antibody complement interaction sites but it really wasn't exciting to me. I didn't really like being in the lab. Um, and you know, this sort of ethics thing, uh was a pulling. I came back to med school because I didn't have an alternative plan, um, and the part of the story that is relevant is that at the end of our first year of medical school. I hated medical school. I liked my peers, but HST because it was a small group of people was actually great.

Dr. Michael Koren: 5:00

That's the MIT-Harvard combination

Dr. Ezekiel Emanuel: 5:03

Health, science and technology program Right.

Dr. Michael Koren: 5:05

Just for the audience. Yes, yep, go ahead.

Dr. Ezekiel Emanuel: 5:07

I, instead of doing the usual I think everyone went to a lab to work for the summer. I went to Washington to intern at a political newspaper, a political magazine there called the New Republic, which was in it. That was one of its heydays of about 20 year stretch of great reporting and stuff. I spent the summer doing that and I realized two things First, there are plenty of people who were way better writers than I was I wasn't that great a writer and second, I didn't want to report on what was happening. I wanted to do what was happening. So I came back again for the second year because I didn't have a plan B. I didn't, you know. It wasn't clear to me what to do. Alternatively, how to actually get this.

Dr. Ezekiel Emanuel: 5:55

Medical ethics thing

Dr. Michael Koren: 5:56

And it really wasn't a terrible gig to be going to Harvard Medical School. Let's face it, but go ahead.

Dr. Ezekiel Emanuel: 6:00

For sure, for sure. But so during that year someone suggested actually one of my brother youngest brother's colleagues was going to Harvard College and suggested that I become a tutor at Harvard, and so I don't know if you remember, but they had us explore teaching opportunity or not teaching. They had us explore different labs to see where people would end up in the lab. So we had an afternoon a week off and I'm like, well, maybe I could teach an afternoon a week at Harvard College instead of being in a lab. And that's what I did and I taught a Harvard major called social studies where you read everyone from basically Thucydides and Plato and Aristotle to Freud and Durkheim, and it was great, I loved it and I said you know this teaching. I really liked that.

Dr. Ezekiel Emanuel: 6:53

So after our third year of medical school, I took off. I got accepted to the Harvard political science Department, called the Gov Department, for a PhD, and I basically stopped medical school and, you know, did the PhD. The thing about it at Harvard was that you only needed 15 months of clinical rotations to graduate and I had had the 15 months summer and by the time I started the PhD I basically could have graduated. But of course you can't because you have to go into internship. And then I did the PhD in four years and then I went back as an intern and this may surprise you, because I'd sort of been off the wards and forgotten a lot of stuff. While I was working on medical ethics related dissertation, I asked to start in the CCU and every time people who aren't doctors think, well, that's crazy. You know, those are the sickest patients in the hospital and I said yeah, and they wouldn't let a fresh intern touch them.

Dr. Michael Koren: 8:07

That's right,

Dr. Ezekiel Emanuel: 8:07

they have experienced nurses, they have a cardiology fellow.

Dr. Ezekiel Emanuel: 8:11

I'd be there and I could learn. I could remember how to take a history. I could remember how to write the order and after two weeks I'd be up to speed which is exactly what happened and it was, you know.

Dr. Ezekiel Emanuel: 8:24

It was very good learning and I met some of our classmates who by that time were fellows because I had taken off for a PhD. Harlan Krumholz, for example, was a cardiology fellow on the service and I short track because I was impatient and after two years I went and became a Farber fellow at the Dana Farber Cancer Institute and did oncology. And I chose oncology for three or four reasons. One coolest science going on in cancer. In the late 80s, early 90s, we were really at the cutting edge. Every patient had end-of-life issue crisis. That was part of my research. I was heavily focused on improving end-of-life care. And last, there was this whole issue of allocation of resources.

Dr. Ezekiel Emanuel: 9:23

We were even back then, 25 years ago 35 years ago, I mean spending a fortune on cancer. We had bone marrow transplants at 100,000 a crack at that time where we thought it was outrageously expensive, and so it had all of these ethical elements and there wasn't anyone who was really systematically dealing with them and they all interested me. So I chose oncology and the Farber was a fabulous place for someone like me because everyone knew that there were big ethical dilemmas but they didn't have anyone who was going to address them.

Dr. Ezekiel Emanuel: 10:02

So I started something called the Ethics Grand Rounds and every month we had a big ethics case that presented and we brought in an expert and everyone showed up. Unlike the other Grand Rounds, everyone found these interesting, personal. Yeah, we had ones about doing things on clinical trials the ethics of phase one oncology trial, and then the Journal of Clinical Oncology, which is the professional journal of the American Society of Clinical Oncology, began running these articles. So I got a lot of academic credibility there and I think it convinced people that ethics and end-of of life care and informed consent and thinking about research ethics and was part of what they should be doing. And they just happened to have me, so it was-

Dr. Michael Koren: 10:55

-f ascinating, yeah, so fascinating.

Dr. Michael Koren: 10:57

You really were a pioneer in that space, quite frankly.

Dr. Ezekiel Emanuel: 11:00

Well, I, I was. Uh, it is the case that, um, the history of bioethics is such that it sort of took off in the United States in 1970, '71. But a lot of the people who were doing it were not well-trained. They were psychiatrists who were doing it because of whatever, or they were retired surgeons who, after retirement, decided this was an interesting, important topic even though they had no training. So a lot of the early stuff was not particularly good.

Dr. Ezekiel Emanuel: 11:33

At the end of the 70s there was a Jimmy Carter appointed a presidential commission on bioethics to look at a lot of things like gene therapies and stuff, and it got a little more professionalized.

Dr. Ezekiel Emanuel: 11:45

But there still weren't people that were. There were only a handful of people who were both physicians and interested in this, who had some training and that were just sort of talking based upon their intuition and guts but actually understood something about ethical reasoning, and so that's the area that was lucky that I had this overlap and I was one of the few people who both you know, frontline clinical back with oncology as well as and I understood a lot of the science and research as well as highly trained in ethics and political philosophy. It gave me a kind of unique position and it was a I would say again, a time when the profession did open up and did say you know, this is core of what we've got to be doing. And so I was in that unique moment and it emphasized for me, you know, a lot of career success is luck. Are you at the right place at the right time and take advantage of that luck. And I did happen to be at the right place.

Dr. Michael Koren: 13:01

Yeah, tremendous. So, as a quick summary, you made your parents proud. They can say my son the oncologist and you are a true pioneer in a kind of a new part of science. The Belmont Report that we'll talk about came out in 1979.

Dr. Ezekiel Emanuel: 13:17

Yeah, I was part of that

Dr. Michael Koren: 13:17

So literally.

Dr. Michael Koren: 13:18

you know, within about a decade of that we were starting to understand how that applied to actual clinical practice and getting people involved in clinical research. And there were very, very few people, as you point out, that had knowledge both on the clinical side and the bioethics side and know how to navigate those tensions which are actually super interesting. So I'm not surprised you had great attendance to the bioethics grand rounds. I'm sure there was some fascinating cases discussed. So kind of give me the little bit of the scoop from going from training to ending up at Penn and ending up at the White House. That's kind of an interesting transition.

Dr. Ezekiel Emanuel: 13:54

Well, I was at the Farber for seven years and then trying to figure out what the next job was.

Dr. Michael Koren: 14:02

So you were an attending physician there for a while, treating cancer patients.

Dr. Ezekiel Emanuel: 14:06

I would put that in quotes. Yes, I was a classic academic physician half a day, a week of clinic.

Dr. Michael Koren: 14:12

Oh, wow, ok, All right, that counts.

Dr. Ezekiel Emanuel: 14:14

Most of my time was spent doing research. I had a teeny, teeny tiny research group. The biggest it ever got to was two people,

Dr. Michael Koren: 14:24

All right

Dr. Ezekiel Emanuel: 14:24

In addition to me, and we were incredible. I mean, you know it.

Dr. Ezekiel Emanuel: 14:28

Just let me say

Dr. Michael Koren: 14:30

yeah, Watson and Crick were a two-person team.

Dr. Ezekiel Emanuel: 14:33

I had two research assistants and you know we were focused on this sort of medical ethics issues, mainly end-of-life care, but we also focused heavily on physician-patient relationship. We wrote a very important paper on how to understand the physician-patient relationship and I should say an interesting thing happened to me at the Farber. All of you who've worked in academic centers know that the coin of the realm is space. There's never enough space and because of what I was doing, um uh, after my second year, you know, I needed to get a space of my own. Um, the head of my department, which happened to be the epidemiology department, um uh took me on a walk, says well, Zeke, you know we're gonna find you new space. And he took me out of the main building at the farber to walk across the parking lot and then there was this little building in the shadow of a power plant. It turned out that that little building housed all the unused um iron lungs.

Dr. Michael Koren: 15:50

Oh geez .

Dr. Ezekiel Emanuel: 15:50

From Polio, from the 50s and he said you know, there's this second floor suite in the back there and you know you can have four rooms. And I realized this is the place where they put all the people who they're not actually firing but want people to leave. It turned out, you know, I thought you know, basically this is Siberia. It turned out to be a blessing in disguise. Sometimes Siberia can be cold and unproductive and a vast wasteland. But for me, I was out of the flow, out of the politics, out of everyone. You know, spending time, wasting time talking about this and that and who was up, who was down, and I simply focused on my work and it. We turned out to have two people and me and we were incredibly productive, um, just banging out the papers, and then in 1996, I believe '95 um, a job came up to. Uh, they were looking for a head of bioethics at the NIH, not just the head. They, the guy who was head of the clinical center, which is the hospital at the at the NIH, was establishing a department and he thought well, we needed you know, the hospital needed to have a bioethics department. So I applied and, um, the two other candidates were much more senior than I. I was, I think, uh, whopping, uh, uh, 38 years old or something, um, and I didn't do any research ethics. You know, since the hospital at the NIH is purely research, there's no routine patient care there, and I had not done any publications in the research space. Uh, in immune, uh, deficiency, uh, diseases, um, chronic granulomatosis, um, for whatever reason, we hit it off. He went to Amherst. I went to Amherst, we had a very nice meeting of personalities and he gave me the job, um, and you know it was a wonderful opportunity to build something from the ground up, uh, and to, you know, invite people. And it got me also interested in research ethics.

Dr. Ezekiel Emanuel: 18:19

At that time this is 1996, 97. I was like, well, you know, all of that research ethics done. We had the Belmont report, we had the declaration of Helsinki, we have federal regulations what more could there be to do? And I scratched the surface. I began reading these documents and realized, you know, there's a lot more to do. These aren't. They're heavily focused on one thing autonomy and informed consent. But there's also much more about the ethics of research that they're not addressing at all. And, by the way, a lot of the literature that had been published, I thought, was again given my unique position as a doctor, a researcher and a bioethicist. It's like I think they've got it wrong and we could do a better job, of sort of fixing it and putting it right. And so it turned out to be a wonderful, wonderful moment to create a department and to really I think we ended up transforming how people think about the ethics of clinical research.

Dr. Michael Koren: 19:32

One super cool and absolutely spot on is that there's been a huge change in the way we perceive ethics. That we'll get into more detail in a moment, but that's just wonderful story. So tell me about the political part of your career, how that came aboard, and you're well known for those contributions, so why don't? You tell us a little bit more about that.

Dr. Ezekiel Emanuel: 19:56

So I worked at the NIH from 97. And then, beginning around 2003, 2004, I could see I'd done almost everything I wanted to do in the research ethics space. Again, it was an incredibly generative from a productivity standpoint, one of the best experiences you could imagine. We had a fellowship, we had people coming right out of college, we had postdocs. They were all brilliant, they were great to work with.

Dr. Ezekiel Emanuel: 20:31

But I could see that I was sort of getting to the end of all the research ethics things I wanted to really write about. Not like I covered everything, but that I wanted to write about. And I was like the thing that's sort of uh, agitating me is going back to my political philosophy. My government polsci roots was, you know, we don't have universal coverage and we need to begin thinking about it and lay the plans for it. So I ended up writing some stuff and teaming up with one of the uh I like to call them the uh uh three original health economists in the country a guy named Victor Fuchs who was a professor at Stanford. He had just retired and you know we had talked about collaborating and some of our ideas overlap and again, that turned out to be incredibly generative. So in '03, '04, '05, we began really publishing a lot.

Dr. Ezekiel Emanuel: 21:32

Romney, uh, uh, Mitt Romney was governor of Massachusetts and and, uh, put in his Romney care, uh, a legislation that created a way for people to get insurance who didn't have insurance and subsidize them. And then, you know, president Obama was his stuff and I was again writing on this and talking about it. And when Obama was elected, he appointed Peter Orszag as head of the Office of Management and Budget. And Peter Orszag asked if I would come and work there as a special assistant working on the Affordable Care Act. And what was important about that is because I was at the NIH, I was a government employee, I could go there and it wouldn't cost the White House a penny, which is always and one of the things you.

Dr. Ezekiel Emanuel: 22:24

Let me just say two things you learn very quickly. First, the Office of Management and Budget is the most powerful agency you never heard of. Actually, it controls all the budgets, it controls all the regulations. It's really a magical place to be. The second thing is that there are never enough people in the White House to handle all the incoming, and so I always tell students, if they ask you to come and sweep the floors at the White House, you say absolutely I will do it because peas are falling off issues. You can do so much. It doesn't get to the presidential level, doesn't even get to the chief of staff level, doesn't get to the National Economic Council level. There's things you can do. So just give you one example I got there and part of what Obama was talking about was we got to reduce regulation.

Dr. Ezekiel Emanuel: 23:22

So I said to Peter Orszag I said you know, there's a lot of regulation around clinical research that is not helping and just creating a lot of paperwork that we could streamline. So he said he ran it up the flagpole. He said okay, you can put together a group. So I could put together a group from HHS. There's, for a variety of reasons, labor and the feds department involvement and we put together a group and within six months we had a draft of the first ever revision of the regulations of human subjects research and it didn't get passed till January 2017, literally as president Obama was leaving the office.

Dr. Ezekiel Emanuel: 24:04

But that's because I left and they didn't have someone driving it and it was being held up by some people at the NIH, ironically enough, but that's the kind of thing you can do at the White House, and I also happened to work on the First Lady Michelle Obama's let's Move initiative, the food, redoing the food pyramid to make it a food plate. So lots of possibilities, but the main thing I was there for was to work on the Affordable Care Act and that was a thrilling, wonderful opportunity. And I like to say, you know, 22, 25 million people got health insurance. If I was one of a thousand people working on that, you know, okay, I take, you know, 0.1% of 25 million people. There's 25,000 people. I helped 25,000 people. You can't do that every day of your life,

Dr. Michael Koren: 25:00

Yeah.

Dr. Ezekiel Emanuel: 25:00

And every year of your life. It's a pretty lucky opportunity.

Dr. Michael Koren: 25:05

Well, thank you for those efforts, not always widely appreciated, but certainly people in the know do appreciate them. So thank you. So tell us a little bit about from this incredible experience obviously became well known through your work on the Affordable Care Act and then ending up at Penn and in your current position and you tell us a little bit about what you do day to day now.

Dr. Ezekiel Emanuel: 25:26

Well, at Penn I had again the same wonderful opportunity to be at the right place at the right time. They were creating, they had a center for bioethics with Arthur Kaplan headed, but they wanted to change it to make it a department and merge it with health policy. So there were PhDs and they had a lot of PhD health policy people working in clinical departments like primary care, and it didn't make any sense. So they wanted to merge or have the bioethicists and the health policy people in one department and make, you know, give it, unlike a center that has no ability to appoint or hire faculty, it would have appointment power. And again, there you. And again there were no people in the department. So I came and started a department, which was again a wonderful opportunity. I think I was selected because I'm one of the few people again who was both a bioethicist and had expertise in health policy Not everyone who whose bioethics can do health policy and few people who do health policy do bioethics. So I actually was one of the few people who had a leg in both sides. I had a great opportunity to attract two absolutely outstanding people to head each division Steve Jaffe, I recruited from Boston Children's Hospital, and Dana Farber, who's an oncologist and expert in bioethics, part. And Kevin Volpe, who people know because of his great work on the role of behavioral economics and healthcare and using incentives in the right way to head the health policy side. I mostly do what I've always done, which is mostly uh, um, research and it's what up in the morning, writing papers. I'm at the moment, um, I've got uh, uh, two books in the air. One's going to be published in January and I'm working, spent the morning here working on chapter six of the next book, which is the one really about.

Dr. Ezekiel Emanuel: 27:36

I'd like to say why America can't achieve any one of the goals of healthcare. We can't get the universal coverage at reasonable costs, with consistent, high quality, reducing, if not eliminating disparities and having high satisfaction for both the physicians and clinicians in the care and patients. We don't have any of the five. Now.

Dr. Ezekiel Emanuel: 27:59

Most other countries have many of the five. They have coverage, they have reasonable costs on it you know 12 percent of GDP going to health care. They have more consistent, high quality and people actually like their system, even the British, you know we always say well, they've got to wait, and it's dirty hospitals and all of this. Well, it turns out you poll the British. They're way proud of their national health service. They may moan about various parts, but we can't achieve, and we have no path for achieving, those five. You know what we're looking at is our health care spend to go above 20 percent of GDP. We're now at five trillion dollars on health care. You know we and we're getting further and further away from universal comfort. So the question is why is that and is there a solution to that?

Dr. Michael Koren: 28:56

Well, definitely have to bring you back to dig into those really important questions in a much more detailed manner.

Dr. Ezekiel Emanuel: 28:59

I have absolutely no doubt. Yeah, To continue watching this podcast episode. Head over to medevidence. com.

Transcript generated by AI

Announcement: 0:00

Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts. Hosted by cardiologist and top medical researcher, Dr. Michael Koren.

Dr. Michael Koren: 0:11

We'll definitely have to bring you back to dig into those really important questions in a much more detailed manner.

Dr. Ezekiel Emanuel: 0:17

I have absolutely no hair.

Dr. Michael Koren: 0:19

Yeah, but I want to spend the rest of our time together focusing on the ethics part of the equation right now, and we talked about the Belmont Report and I've been interested in that as well.

Dr. Michael Koren: 0:31

I'm a cardiologist and certainly somebody that's done a lot of research but also been really interested in all these ethical tensions that occur in the clinical research realm.

Dr. Michael Koren: 0:41

And, just for everybody's knowledge, the Belmont Report came out in 1979.

Dr. Michael Koren: 0:45

There are three overarching principles, which is Autonomy, or what we call respect for persons and that's actually changed over the years, which is kind of interesting and this is the concept that all consent for study should be free consent and, for people who may not have full autonomy or full knowledge, that we help them appropriately. Then we have Distributive Justice, which is that the burdens or the risks of research can fall on the same people all the time. And then we have Beneficence, which is our responsibility to try to make all the research studies as beneficial as possible and to reduce risk for the patients as we design them. So those are the three basic principles and the reason I'm bringing those up is because we're super interested here in MedEvidence of the concept of research as a care option, and you and I were just talking about before, when we say that it's fundamentally different than research as a treatment option. So maybe I know that you've done some work in this area, so maybe you can educate us a little bit more on that distinction.

Dr. Ezekiel Emanuel: 1:47

Well, this is actually one of those interesting areas where, you know, I looked at the Belmont report and I thought, you know, and in 79, laying out those three principles was very important, but I think they didn't get it quite right. And part of what one of my most famous, most highly cited let's put it that way, articles is what makes clinical research ethical, and we delineated that there are seven principles that you actually have to do. One is there has to be social value to the research. You know, if you don't disseminate your results, if you don't make them available, if it's not answering an important question, you shouldn't be doing the research. It's got to be scientifically valid. Are you going to get it, are you designed it to get it, A real answer, because if you're doing a randomized trial of 20 people and you know you don't have some whopping big effect, the data is going to be garbage and you can't put people at risk for no scientific advance

Dr. Michael Koren: 2:56

Right.

Dr. Ezekiel Emanuel: 2:57

Third thing is to fit to, as you put it, the distributive justice one. You have to choose fairly the people who are going to participate. You can't say, for a super beneficial study, heavily get people who are well off or connected to the board or whatever, and for a highly risky study, get only people who are minorities or low income or low education. And then you know you have to have a review, independent review, because as researchers we're always biased for our research. So you need an independent review. We have an IRB system. Doesn't have to be that system, it does have to be independent. And then you have to have informed consent. And then we added the last one, which is look, people participated in research. You have to disseminate that and you have to inform them what was learned. You can't just forget them. So all of these are really important. One of the things and again, you know, being trained as an oncologist, it was sort of at the Farber mother's milk that you know that clinical research is the best way to go and we were always trying to see why that people should get on research studies. And there are good reasons to think about it. It's standardized. Some of the smartest people in the world have worked on developing a protocol so that you know you are getting good standard of care and you're getting all the right tests and treatment. And there's people looking at your situation there's people looking at the data to make sure that nothing's going awry. So I think that there's a lot of positives there. Actually, thinking about your point that you made at the start, I think you know it led me to write a paper which I talked about people's obligation to participate in research.

Dr. Ezekiel Emanuel: 5:06

When the Belmont report was written, a lot of that was like protecting people from research. Why did we end up with the Belmont report and the whole presidential commission? Well, we ended up with it because of a scandal, the Tuskegee scandal, and this was the response to the Tuskegee scandal. To try to make sure it wouldn't happen again, we'd have bioethicists thinking about all the ethical issues and that framework right. Research is dangerous, research is risky, research is going to hurt people is what led to the Belmont report and the regulations. And my view is we, because of the Tuskegee, largely because of the Belmont we did put in a infrastructure, including IRB review, including informed consent, to protect people.

Dr. Ezekiel Emanuel: 5:56

But once we had that structure, we could be pretty confident that research was safe. And again, it also meant that all of us who take a pill every day we're the beneficiaries of that research right. That pill has been shown to be safe and effective and so we benefit by someone else having participated in the research. I think that actually gives us an obligation as people to actually participate ourselves when the opportunity presents itself. And I think we have. We, the bioethicists, the medical community, spend so much time trying to protect people. We haven't thought about our obligation to participate in ethical research. Now, it has to be ethical. It has to have a risk benefit ratio where the risks are appropriate to the benefits. It has to be that people are fairly selected, it doesn't target one vulnerable group, etc. But if it fulfills all that, we do have, I think, an obligation which we don't talk about in America, very much.

Dr. Ezekiel Emanuel: 7:06

We don't say it.

Dr. Michael Koren: 7:07

I think those are amazing points and I like the emphasis on encouraging people to be part of research, but not only for societal benefit, but also for personal benefit.

Dr. Ezekiel Emanuel: 7:12

Yeah I always think it's a 2-for-1. It's good for you, but its good for people around you. And by the way, since many of the things we research. Have, you know, a family

Dr. Ezekiel Emanuel: 7:31

lineage relationship or raised in the same environment. You may in fact be benefiting your family by what you do, because you advance the science and knowledge of some condition or disease or a genetic disorder, and that's all very, very important, I think.

Dr. Michael Koren: 7:50

Yeah, there's a really interesting nuance in the Tuskegee scandal. I want to get your take on this, which is as you know, but I'm articulating this for the audience. This is a study that started in the 1930s let's look at the natural history of syphilis when there really wasn't any treatment for it, and this study continued for close to 40 years until there was an expose in the Washington Star that talked about how this research was going on and the men about 400 black men, who are uneducated were not told about their participation in research, and this happened for over 40 years, and this is, of course, quite scandalous. It's horrible, it was exploitative, but there's another side to it that's interesting. One is that there was actually a lot of learning from it. So, while we've apologized to these men that participate in the study, we've never thanked them for being in the study. Thank you for allowing us to learn, and we've never done that, and I think that's a miss.

Dr. Michael Koren: 8:52

The other thing is that it's an interesting dynamic between racism and socioeconomic issues. So the Tuskegee study was actually performed at a traditionally black university, tuskegee, and during the course of this 40 years, the government was very involved, by the way, doing some horrible things, like, for example, when members of the Tuskegee study group were drafted into the military, they were not allowed to get penicillin shots because it would mess up the study. So that's just absolutely horrible. But the government also was in consultation with African-American groups during this whole discussion. So as late as 1969, the CDC evaluated the study and felt like it should continue under the current rules, including consultation with black physicians.

Dr. Michael Koren: 9:42

So here again is this concept that has been, I think, somewhat misunderstood by the general public, that this was a socioeconomic gulf between the physician community, the medical community and people who are not educated. And we've made a lot, a lot of progress, as you point out, with IRBs and informed consent forms, et cetera. In fact, if anything, we may be going overboard, because when you have a 35-page consent form that changes every week, you're not going to necessarily be communicating with people that have less than a high educational level, and so, when you think about these things, they're ways of excluding people who are in lower socioeconomic classes from participating in something that's not only important for society but important for them in terms of both direct and indirect benefits, including being in a medical community, having really good, ethical, smart people looking out for you and then knowing how to navigate the health system, because you have somebody that's helping you in a very complex set of rules that we all have to navigate. So I don't know your reaction to that, but I'm curious to hear it.

Dr. Michael Koren: 10:49

So I don't know your reaction to that, but I'm curious to hear it.

Dr. Ezekiel Emanuel: 11:11

So I think that there's some controversy over whether the study ever -needed, was beneficial the sense of adding to scientific knowledge, even in the '30's. Because there was a fair amount of understanding of the natural history of syphiis, and part of the idea was, well was a natural history, and this is where I think some of the racism, even at the start, came in: was the natural history different in black men than in whites. And so I think there is some controversy on whether in fact, from a scientific standpoint, it needed to be done. It was quite clear that when penicillin became widely available and effective against syphilis, that it was consciously and explicitly withheld. That is clearly unethical.

Dr. Michael Koren: 11:40

That's absolutely horrible.

Dr. Ezekiel Emanuel: 11:41

No justification for that. And that is 20 years before the whole thing, easily 20 years, maybe more, before the whole thing ended, as you say, on an expose by one of the staff members who was upset by the situation. It also did, as you point out, it was done in conjunction with African-American leaders and physicians in the community and that you know that power dynamic, socioeconomic dynamic, education dynamic I think was problematic and there was no one who was necessarily looking out for the sharecroppers who were enrolled. And I do think you know one of the problems that has resulted, and I think you point out very well, is you know we now have this apparatus and infrastructure to protect people through IRB review and informed consent and it's, you know, one of the reasons I launched a revision of the regulations is it's become encrusted, nothing sticking around. And you point out one of them. Our informed consent arguments are way too long for what they do.

Dr. Ezekiel Emanuel: 13:04

They're written at an average 11th grade level. They have way too much boilerplate. It's part of the area I've done a fair amount of recent research in getting back into this informed consent thing. I've shown that, for example, the COVID vaccine informed consents were 40 pages, outrageous, and you could reduce hundreds of words to a short sentence. We have worked with a couple of drug companies that are very interested in trying to reduce their informed consent form text; and make it more readable and bring the age down of the reading level down so that they could get more people involved. It does you know, when you have a big document like that, it intimidates people, or they simply ignore it and just trust whatever they're told about it from the doctor or from the nurse who is telling them about the study. That's not exactly what you want.

Dr. Michael Koren: 14:03

Well, it sends the wrong impression. So if it requires a 40-page document for you to be in it, you think, oh my God, this must be incredibly risky, what am I signing up for? And, quite frankly, there's really no way to assess the true risk within those 40 pages.

Dr. Ezekiel Emanuel: 14:19

Well, again, one of the things I've long argued is look if you have an IRB that's well-functioning. The main thing that they're really got to be entrusted with is the risk-benefit ratio, the right risk-benefit ratio.

Dr. Ezekiel Emanuel: 14:34

Do we have enough knowledge. That's not to say you know things can turn out to be risky, even though an IRB approved them. That's why we're doing the research, because we don't know the full measure of the risk or the benefits. But you have the value of an independent group looking at this and assessing the pluses and minuses of that research study, by the way, which you don't have in regular clinical medicine. Not everything in clinical medicine has been tested to the degree that drugs have been tested.

Dr. Ezekiel Emanuel: 15:08

That's one of the big problems, I think, is we have a very uneven system. The devices don't have to go through the same rigorous, randomized, controlled trials and things like that. So I think we've overdone it in the 45 years since the regulations have been written and I think we need a fresh examination. But this is like many things once you write it down and it becomes institutionalized, it gets very hard to reform things and people have sort of standard operating procedures which are not necessarily conducive. And again, a lot of that is built on the idea that, well, research is really risky, well, life has got some risks and we've got to put it all in context, and that's actually one of the things I've written a lot about how do we compare the risks of research with the risks of everyday life. It turns out, given the risks of everyday life, turns out, given the risks of everyday life, the big one for most adults, driving. The big one for kids other accidents, drownings, things like that, and so playing sports also.

Dr. Michael Koren: 16:24

You're much safer in the research office than you are out living in the world.

Dr. Ezekiel Emanuel: 16:27

It's one of the important points and I think we don't sufficiently make that comparison. Well, how risky is everyday life? We just assume, you know, we become habituated to the risk. Every time you put your key in that car, what's the chances that you might? You know, chance are about one, and I think it's one in a hundred, of being in an accident every year, and I forget all the data, but it's not trivial.

Dr. Michael Koren: 16:50

Sure, no, absolutely so. Would you have a family member do research?

Dr. Ezekiel Emanuel: 16:55

Oh, I do research. So, um, um, my kids were raised with, uh, lots of talk about medicine. They went off to college, Every one of them participated in clinical research studies. \I every year participate in a flu vaccine study. They take out a large amount of my blood after the vaccine. I participated in MRI studies. I participated in studies about concentration and shocks. I even got that protocol changed. I'm not shy about talking up. I've tried to get into a variety of cardiology studies because I have a high cholesterol, but it's high because my HDL is very high.

Dr. Michael Koren: 17:45

That's good!

Dr. Ezekiel Emanuel: 17:46

I never qualified for those studies and so, yeah, I think again. I have the view that you know we're all the beneficiary of people who've enrolled in clinical research. We ought to do it when we can.

Dr. Michael Koren: 18:02

Do you feel cared for in those studies?

Dr. Ezekiel Emanuel: 18:04

Yeah, I feel look, I will actually tell you what I do is I feel like I'm making my small contribution to making healthcare better in the future.

Dr. Michael Koren: 18:15

Yeah, and again, just to sort of reiterate my point, when doctors talk about treatment, it's what we know, that you're getting as part of a plan to create some therapeutic benefit based on what we know or we think we know, whereas in research we don't know that usually, and so what we can provide is just that being a part of a community learning about your health condition, hopefully identifying other things that may help you live a better life, for both yourself and your loved ones.

Dr. Michael Koren: 18:46

So, there's lots of elements of care that are separate from the treatment elements, what we do as physicians.

Dr. Ezekiel Emanuel: 18:52

Absolutely. I mean treatment's only one. As you point out, treatment's only one very small part of what medicine is about.

Dr. Michael Koren: 19:00

Absolutely, absolutely. So, This has been a great discussion. I've enjoyed every minute of it. So just to kind of summarize, what's your view for the next five to 10 years for yourself professionally, and what maybe you predict for us in terms of the research world?

Dr. Ezekiel Emanuel: 19:17

Well, I'm going to keep working, keep writing. I've got after the book I'm working on right now. I've got two more ideas, one of which is about how to retire. I think we do it Well. One of the things I've become very interested in is the impact of what we do during retirement, how that affects dimentia, cognitive decline, what we do, how we could do it better. I think many people could use advice about how to do it better. I think there are certain things that we're discovering that can, if you do it right. One of the problems is we often just retire instead of retire with a plan. I think everyone needs a plan for retirement. Anyway, that's another book.

Dr. Michael Koren: 20:07

Well, you had a plan in medical school, so I'm sure you'll have a plan for retirement.

Dr. Ezekiel Emanuel: 20:12

Then I've got another book after that, so that'll take me to 75. And then, who knows?

Dr. Michael Koren: 20:19

Well, that's one of your controversial statements, I think. If you want to address that, one of the things you're known for is I think people maybe have misinterpreted that, but the general interpretation is that Zeke Emanuel thinks you hit 75 and just hang it up and you go out to pasture and never come back. So maybe you can address that statement

Dr. Ezekiel Emanuel: 20:39

You're 100% right.

Dr. Ezekiel Emanuel: 20:41

That's very wrong interpretation. So the title of the article is called why I Want to Die at 75. It was in the Atlantic 11 years ago, in 2014. As I like to tell people, you don't, as an author, you do not choose your title. That is left to the editors and publishers. Your interest in accuracy and their interest in selling a lot of magazines are not necessarily conjoined, right, and this is one where I did fight hard about that title and I lost.

Dr. Ezekiel Emanuel: 21:16

Yeah, my philosophy is that I don't want life-saving like cancer chemotherapy after 75. I don't want an intervention where the purpose of the intervention is to prolong my life. On the other hand, if you know, I was in it. This happened to a friend of ours, which is why it's hot on my mind. But if I was in a ski line and someone came and barreled into me and knocked me down and I broke my hip, I would want that hip fixed. If I get cataracts, I want those cataracts replaced, even though they're not going to save my life. So I want to live a full life. I think I'm still living a pretty full life.

Dr. Ezekiel Emanuel: 21:54

Uh, you know, two days ago I went out and rode 25 miles. Yesterday rode 15 miles on my bicycle pretty good clip 17 miles an hour. So, um, I'm very active and I try to do new things. This coming weekend I will harvest my honey from my beehives. So the problem at 75 is that if you look at the data, you know cognitive decline goes up, alzheimer's risk goes up, you know the wheels begin to come off the car, our functional capacity goes down, we lose a lot of muscle mass. You have to consciously maintain your muscle mass. I'm not planning to retire and hopefully cognitive decline won't afflict me. Um, but it does take um. You know there is a a very clear um inflection point at about 75. Is it true for everyone? No, a lot of people say, well, if it were just 80?

Dr. Ezekiel Emanuel: 22:59

well, yeah yeah, the fact is 75, when it goes up like a hockey stick, um, and all of us think we're going to be outliers. I'm a little more sober about that. Not everyone can be an outlier. I'm talking about averages. Yes, there will be some outliers. I have done I taught a course and created a video on Coursera about Benjamin Franklin.

Dr. Ezekiel Emanuel: 23:22

I think he's the most remarkable person ever born in an America. He was excelled at all sorts of things and he was an outlier. Everyone talks about his inventing bifocals. He was 79 when he invented bifocals. Not many people are inventing something that sticks around for 250 years in their 79th year and after that he still had more inventions that you know about the arm to lift up and grab something from a high shelf. Ben Franklin, he needed to grab his books. Anyway, he is a model, but not all of us are going to be like that, and so we have to think about what happens when we're not going to be there, and that was the point of the book. I told people my philosophy. I wasn't saying everyone should adopt my philosophy, but everyone should have a philosophy and they should think about a philosophy and they shouldn't just have it come upon them.

Dr. Ezekiel Emanuel: 24:20

I don't particularly endorse, and I would argue with anyone who has a sort of what I call the Silicon Valley view of life, which is I got to live forever. What's the world going to be if I die? Yes, the world will continue, I can guarantee that, and I think trying to live forever is got it. You know, excuse me, but ass backwards. Right, the point is to live a rich life, right? If you make the focus of your life living forever, there's no content to it, there's no meaning, there's no fulfillment to it, and that, I think, mistakes what we are on this planet to do. We're on this planet to make the world better, to make our loved ones better people, to make ourselves better people, and not to just live forever.

Dr. Michael Koren: 25:12

Well, speaking of Benjamin Franklin, there's a quote, I believe, from poor Richard's Almanac that is attributed to Ben Franklin, that the goal of life should be to live well, not necessarily live long. So that gets your philosophy. Although he did both, quite frankly, he lived long and he lived well. But I'd also argue that there are lots of people that make amazing contributions well into their 70s, 80s and even 90s. You look at people like Warren Buffett.

Dr. Ezekiel Emanuel: 25:38

You and I may disagree.

Dr. Michael Koren: 25:39

Yeah, so my brain works just as well now in my 60s as it did in my 30s in some ways better, and if I extrapolate that, it should be working really well by the time I get to 90. And so we'll see.

Dr. Ezekiel Emanuel: 25:55

We'll revisit that in a few years.

Dr. Michael Koren: 25:57

Yeah, we'll definitely do this again in about 10 years and we'll see if our views have changed. But again, I think that we're a wealthy country. We can support people. I think perhaps a little bit beyond the 70s and quite frankly, to your point.

Dr. Ezekiel Emanuel: 26:12

No, no, no, Wait, wait, wait, wait. This is not about wealthy countries supporting people. This is about your personal philosophy. It has nothing to do. Even if you're magnificently rich, you'll support yourself. Blah, blah, blah.

Dr. Michael Koren: 26:23

No, no, I'm talking about society, your philosophy, like contrast. As you know, in Great Britain, for example, there are limitations of what treatments are performed at certain ages.

Dr. Ezekiel Emanuel: 26:33

Well, we know that in the United States it's the same thing, even if it's not a policy doctors, they don't admit 80-year-olds with the same thing as 70-year-olds to the ICU, et cetera. So I'm not sure I agree with that. Yes, we don't have a formal policy, but we have practices that people have imbibed, and you know it's anyway. And my article is not about public policy. It's very, very firmly in challenging each of us to have a personal philosophy about how we want to live, how long we want to live. You know I ask this all the time when I talk. You know you want quantity or you want quality of life. Oh, we all want quality of life. And then you talk to them and you know they just haven't thought through what that might mean. And when we get to that, you know the default of the system is quantity over quality.

Dr. Michael Koren: 27:35

Easier to measure quantity versus quality.

Dr. Ezekiel Emanuel: 27:38

Yes 100%.

Dr. Michael Koren: 27:39

Yeah, so fair enough. Well, Zeke, this has been an amazing conversation. Thank you for being a guest here on. MedEvidence and it's been my absolute pleasure and hopefully we'll do it again very, very soon and you can share some of your amazing insights with us.

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