September 3, 2025 • 28 mins
The conversation between Dr. Michael Koren and Dr. Zeke Emanuel continues in part 2. Bioethicist Zeke Emanuel dives into the unethical Tuskeegee study and landmark Belmont Report in 1979 and how many safeguards to clinical research are currently in effect. They doctoral duo also talk about how in spite of the potentially off-putting document-heavy nature of current clinical research participation, it is still a good care option and a moral obligation for those who benefit from the fruits of medical research.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Announcement (00:00):
Welcome to MedEvidence, where we help you
navigate the truth behindmedical research with unbiased,
evidence-proven facts.
Hosted by cardiologist and topmedical researcher, Dr.
Michael Koren.
Dr. Michael Koren (00:11):
We'll definitely have to bring you
back to dig into those reallyimportant questions in a much
more detailed manner.
Dr. Ezekiel Emanuel (00:17):
I have absolutely no hair.
Dr. Michael Koren (00:19):
Yeah, but I want to spend the rest of our
time together focusing on theethics part of the equation
right now, and we talked aboutthe Belmont Report and I've been
interested in that as well.
I'm a cardiologist and certainlysomebody that's done a lot of
research but also been reallyinterested in all these ethical
tensions that occur in theclinical research realm.
(00:41):
And, just for everybody'sknowledge, the Belmont Report
came out in 1979.
There are three overarchingprinciples, which is Autonomy,
or what we call respect forpersons and that's actually
changed over the years, which iskind of interesting and this is
the concept that all consentfor study should be free consent
and, for people who may nothave full autonomy or full
(01:03):
knowledge, that we help themappropriately.
Then we have DistributiveJustice, which is that the
burdens or the risks of researchcan fall on the same people all
the time.
And then we have Beneficence,which is our responsibility to
try to make all the researchstudies as beneficial as
possible and to reduce risk forthe patients as we design them.
So those are the three basicprinciples and the reason I'm
(01:26):
bringing those up is becausewe're super interested here in
MedEvidence of the concept ofresearch as a care option, and
you and I were just talkingabout before, when we say that
it's fundamentally differentthan research as a treatment
option.
So maybe I know that you'vedone some work in this area, so
maybe you can educate us alittle bit more on that
distinction.
Dr. Ezekiel Emanuel (01:47):
Well, this is actually one of those
interesting areas where, youknow, I looked at the Belmont
report and I thought, you know,and in 79, laying out those
three principles was veryimportant, but I think they
didn't get it quite right.
(02:07):
And part of what one of my mostfamous, most highly cited let's
put it that way, articles iswhat makes clinical research
ethical, and we delineated thatthere are seven principles that
you actually have to do.
One is there has to be socialvalue to the research.
You know, if you don'tdisseminate your results, if you
(02:30):
don't make them available, ifit's not answering an important
question, you shouldn't be doingthe research.
It's got to be scientificallyvalid.
Are you going to get it, areyou designed it to get it, A
real answer, because if you'redoing a randomized trial of 20
people and you know you don'thave some whopping big effect,
the data is going to be garbageand you can't put people at risk
(02:52):
for no scientific advance
Dr. Michael Koren (02:56):
Right.
Dr. Ezekiel Emanuel (02:57):
Third thing is to fit to, as you put it,
the distributive justice one.
You have to choose fairly thepeople who are going to
participate.
You can't say, for a superbeneficial study, heavily get
people who are well off orconnected to the board or
whatever, and for a highly riskystudy, get only people who are
(03:18):
minorities or low income or loweducation.
And then you know you have tohave a review, independent
review, because as researcherswe're always biased for our
research.
So you need an independentreview.
We have an IRB system.
Doesn't have to be that system,it does have to be independent.
And then you have to haveinformed consent.
(03:40):
And then we added the last one,which is look, people
participated in research.
You have to disseminate thatand you have to inform them what
was learned.
You can't just forget them.
So all of these are reallyimportant.
One of the things and again,you know, being trained as an
(04:01):
oncologist, it was sort of atthe Farber mother's milk that
you know that clinical researchis the best way to go and we
were always trying to see whythat people should get on
research studies.
And there are good reasons tothink about it.
(04:23):
It's standardized.
Some of the smartest people inthe world have worked on
developing a protocol so thatyou know you are getting good
standard of care and you'regetting all the right tests and
treatment.
And there's people looking atyour situation there's people
looking at the data to make surethat nothing's going awry.
(04:45):
So I think that there's a lotof positives there.
Actually, thinking about yourpoint that you made at the start
, I think you know it led me towrite a paper which I talked
about people's obligation toparticipate in research.
(05:06):
When the Belmont report waswritten, a lot of that was like
protecting people from research.
Why did we end up with theBelmont report and the whole
presidential commission?
Well, we ended up with itbecause of a scandal, the
Tuskegee scandal, and this wasthe response to the Tuskegee
scandal.
To try to make sure it wouldn'thappen again, we'd have
(05:28):
bioethicists thinking about allthe ethical issues and that
framework right.
Research is dangerous, researchis risky, research is going to
hurt people is what led to theBelmont report and the
regulations.
And my view is we, because ofthe Tuskegee, largely because of
the Belmont we did put in ainfrastructure, including IRB
(05:51):
review, including informedconsent, to protect people.
But once we had that structure,we could be pretty confident
that research was safe.
And again, it also meant thatall of us who take a pill every
day we're the beneficiaries ofthat research right.
(06:12):
That pill has been shown to besafe and effective and so we
benefit by someone else havingparticipated in the research.
I think that actually gives usan obligation as people to
actually participate ourselveswhen the opportunity presents
itself.
And I think we have.
(06:35):
We, the bioethicists, themedical community, spend so much
time trying to protect people.
We haven't thought about ourobligation to participate in
ethical research.
Now, it has to be ethical.
It has to have a risk benefitratio where the risks are
appropriate to the benefits.
It has to be that people arefairly selected, it doesn't
target one vulnerable group, etc.
(06:57):
But if it fulfills all that, wedo have, I think, an obligation
which we don't talk about inAmerica, very much.
We don't say it.
Dr. Michael Koren (07:07):
I think those are amazing points and I like
the emphasis on encouragingpeople to be part of research,
but not only for societalbenefit, but also for personal
benefit.
Dr. Ezekiel Emanuel (07:12):
Yeah I always think it's a 2-for-1.
It's good for you, but its goodfor people around you.
And by the way, since many ofthe things we research.
Have, you know, a familylineage relationship or raised
(07:34):
in the same environment.
You may in fact be benefitingyour family by what you do,
because you advance the scienceand knowledge of some condition
or disease or a genetic disorder, and that's all very, very
important, I think.
Dr. Michael Koren (07:50):
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 theaudience.
This is a study that started inthe 1930s let's look at the
natural history of syphilis whenthere really wasn't any
treatment for it, and this studycontinued for close to 40 years
(08:14):
until there was an expose inthe Washington Star that talked
about how this research wasgoing on and the men about 400
black men, who are uneducatedwere not told about their
participation in research, andthis happened for over 40 years,
and this is, of course, quitescandalous.
It's horrible, it wasexploitative, but there's
(08:35):
another side to it that'sinteresting.
One is that there was actuallya lot of learning from it.
So, while we've apologized tothese men that participate in
the study, we've never thankedthem for being in the study.
Thank you for allowing us tolearn, and we've never done that
, and I think that's a miss.
The other thing is that it's aninteresting dynamic between
(08:55):
racism and socioeconomic issues.
So the Tuskegee study wasactually performed at a
traditionally black university,tuskegee, and during the course
of this 40 years, the governmentwas very involved, by the way,
doing some horrible things, like, for example, when members of
the Tuskegee study group weredrafted into the military, they
(09:17):
were not allowed to getpenicillin shots because it
would mess up the study.
So that's just absolutelyhorrible.
But the government also was inconsultation with
African-American groups duringthis whole discussion.
So as late as 1969, the CDCevaluated the study and felt
like it should continue underthe current rules, including
(09:40):
consultation with blackphysicians.
So here again is this conceptthat has been, I think, somewhat
misunderstood by the generalpublic, that this was a
socioeconomic gulf between thephysician community, the medical
community and people who arenot educated.
And we've made a lot, a lot ofprogress, as you point out, with
IRBs and informed consent forms, et cetera.
(10:02):
In fact, if anything, we may begoing overboard, because when
you have a 35-page consent formthat changes every week, you're
not going to necessarily becommunicating with people that
have less than a higheducational level, and so, when
you think about these things,they're ways of excluding people
who are in lower socioeconomicclasses from participating in
(10:25):
something that's not onlyimportant for society but
important for them in terms ofboth direct and indirect
benefits, including being in amedical community, having really
good, ethical, smart peoplelooking out for you and then
knowing how to navigate thehealth system, because you have
somebody that's helping you in avery complex set of rules that
we all have to navigate.
So I don't know your reactionto that, but I'm curious to hear
(10:48):
it.
So I don't know your reaction tothat, 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 scientificknowledge, even in the '30's.
Because there was a fair amountof understanding of the natural
history of syphiis, and part ofthe idea was, well was a
natural history, and this iswhere I think some of the
racism, even at the start, camein: was the natural history
different in black men than inwhites.
And so I think there is somecontroversy on whether in fact,
from a scientific standpoint, itneeded to be done.
It was quite clear that whenpenicillin became widely
(11:31):
available and effective againstsyphilis, that it was
consciously and explicitlywithheld.
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 thewhole thing, easily 20 years,
maybe more, before the wholething ended, as you say, on an
expose by one of the staffmembers who was upset by the
situation.
It also did, as you point out,it was done in conjunction with
(12:04):
African-American leaders andphysicians in the community and
that you know that power dynamic, socioeconomic dynamic,
education dynamic I think wasproblematic and there was no one
who was necessarily looking outfor the sharecroppers who were
(12:30):
enrolled.
And I do think you know one ofthe problems that has resulted,
and I think you point out verywell, is you know we now have
this apparatus andinfrastructure to protect people
through IRB review and informedconsent and it's, you know, one
of the reasons I launched arevision of the regulations is
(12:52):
it's become encrusted, nothingsticking around.
And you point out one of them.
Our informed consent argumentsare way too long for what they
do.
They're written at an average11th grade level.
They have way too muchboilerplate.
It's part of the area I've donea fair amount of recent
(13:13):
research in getting back intothis 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 shortsentence.
We have worked with a couple ofdrug companies that are very
interested in trying to reducetheir informed consent form
(13:35):
text; and make it more readableand bring the age down of the
reading level down so that theycould get more people involved.
It does you know, when you havea big document like that, it
intimidates people, or theysimply ignore it and just trust
whatever they're told about itfrom the doctor or from the
(13:55):
nurse who is telling them aboutthe study.
That's not exactly what youwant.
Dr. Michael Koren (14:03):
Well, it sends the wrong impression.
So if it requires a 40-pagedocument for you to be in it,
you think, oh my God, this mustbe incredibly risky, what am I
signing up for?
And, quite frankly, there'sreally 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 anIRB that's well-functioning.
The main thing that they'rereally got to be entrusted with
is the risk-benefit ratio, theright risk-benefit ratio.
Do we have enough knowledge.
That's not to say you knowthings can turn out to be risky,
(14:39):
even though an IRB approvedthem.
That's why we're doing theresearch, because we don't know
the full measure of the risk orthe benefits.
But you have the value of anindependent group looking at
this and assessing the plusesand minuses of that research
study, by the way, which youdon't have in regular clinical
(15:02):
medicine.
Not everything in clinicalmedicine has been tested to the
degree that drugs have beentested.
That's one of the big problems,I think, is we have a very
uneven system.
The devices don't have to gothrough the same rigorous,
randomized, controlled trialsand things like that.
So I think we've overdone it inthe 45 years since the
(15:28):
regulations have been writtenand I think we need a fresh
examination.
But this is like many thingsonce you write it down and it
becomes institutionalized, itgets very hard to reform things
and people have sort of standardoperating procedures which are
not necessarily conducive.
(15:48):
And again, a lot of that isbuilt on the idea that, well,
research is really risky, well,life has got some risks and
we've got to put it all incontext, and that's actually one
of the things I've written alot about how do we compare the
risks of research with the risksof everyday life.
It turns out, given the risksof everyday life, turns out,
given the risks of everyday life, the big one for most adults,
(16:11):
driving.
The big one for kids otheraccidents, drownings, things
like that, and so playing sportsalso.
Dr. Michael Koren (16:24):
You're much safer in the research office
than you are out living in theworld.
Dr. Ezekiel Emanuel (16:27):
It's one of the important points and I
think we don't sufficiently makethat comparison.
Well, how risky is everydaylife?
We just assume, you know, webecome habituated to the risk.
Every time you put your key inthat 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 accidentevery year, and I forget all
(16:48):
the data, but it's not trivial.
Dr. Michael Koren (16:50):
Sure, no, absolutely so.
Would you have a family memberdo research?
Dr. Ezekiel Emanuel (16:55):
Oh, I do research.
So, um, um, my kids were raisedwith, uh, lots of talk about
medicine.
They went off to college, Everyone of them participated in
clinical research studies.
\I every year participate in aflu vaccine study.
They take out a large amount ofmy blood after the vaccine.
(17:18):
I participated in MRI studies.
I participated in studies aboutconcentration and shocks.
I even got that protocolchanged.
I'm not shy about talking up.
I've tried to get into avariety of cardiology studies
(17:38):
because I have a highcholesterol, 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 knowwe're all the beneficiary of
people who've enrolled inclinical 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'mmaking my small contribution to
making healthcare better in thefuture.
Dr. Michael Koren (18:15):
Yeah, and again, just to sort of reiterate
my point, when doctors talkabout treatment, it's what we
know, that you're getting aspart of a plan to create some
therapeutic benefit based onwhat we know or we think we know
, whereas in research we don'tknow that usually, and so what
we can provide is just thatbeing a part of a community
(18:37):
learning about your healthcondition, hopefully identifying
other things that may help youlive a better life, for both
yourself and your loved ones.
So, there's lots of elements ofcare that are separate from the
treatment elements, what we doas physicians.
Dr. Ezekiel Emanuel (18:52):
Absolutely.
I mean treatment's only one.
As you point out, treatment'sonly one very small part of what
medicine is about.
Dr. Michael Koren (19:00):
Absolutely, absolutely.
So, This has been a greatdiscussion.
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 yourselfprofessionally, and what maybe
you predict for us in terms ofthe research world?
Dr. Ezekiel Emanuel (19:17):
Well, I'm going to keep working, keep
writing.
I've got after the book I'mworking on right now.
I've got two more ideas, one ofwhich is about how to retire.
I think we do it Well.
One of the things I've becomevery interested in is the impact
(19:39):
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 useadvice about how to do it better
.
I think there are certainthings that we're discovering
that can, if you do it right.
One of the problems is we oftenjust retire instead of retire
(20:02):
with a plan.
I think everyone needs a planfor 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 forretirement.
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 havemisinterpreted that, but the
general interpretation is thatZeke Emanuel thinks you hit 75
and just hang it up and you goout to pasture and never come
back.
So maybe you can address thatstatement
Dr. Ezekiel Emanuel (20:39):
You're 100% right.
That's very wrong interpretation.
So the title of the article iscalled why I Want to Die at 75.
It was in the Atlantic 11 yearsago, in 2014.
As I like to tell people, youdon't, as an author, you do not
choose your title.
That is left to the editors andpublishers.
(21:00):
Your interest in accuracy andtheir interest in selling a lot
of magazines are not necessarilyconjoined, right, and this is
one where I did fight hard aboutthat title and I lost.
Yeah, my philosophy is that Idon't want life-saving like
(21:20):
cancer chemotherapy after 75.
I don't want an interventionwhere the purpose of the
intervention is to prolong mylife.
On the other hand, if you know,I was in it.
This happened to a friend ofours, which is why it's hot on
my mind.
But if I was in a ski line andsomeone came and barreled into
me and knocked me down and Ibroke my hip, I would want that
(21:41):
hip fixed.
If I get cataracts, I wantthose cataracts replaced, even
though they're not going to savemy life.
So I want to live a full life.
I think I'm still living apretty full life.
Uh, you know, two days ago Iwent out and rode 25 miles.
Yesterday rode 15 miles on mybicycle pretty good clip 17
(22:02):
miles an hour.
So, um, I'm very active and Itry to do new things.
This coming weekend I willharvest my honey from my
beehives.
So the problem at 75 is that ifyou look at the data, you know
cognitive decline goes up,alzheimer's risk goes up, you
(22:24):
know the wheels begin to comeoff the car, our functional
capacity goes down, we lose alot of muscle mass.
You have to consciouslymaintain your muscle mass.
I'm not planning to retire andhopefully cognitive decline
won't afflict me.
Um, but it does take um.
(22:55):
You know there is a a veryclear um inflection point at
about 75.
Is it true for everyone?
No, a lot of people say, well,if it were just 80?
well, yeah yeah, the fact is 75,when it goes up like a hockey
stick, um, and all of us thinkwe're going to be outliers.
I'm a little more sober aboutthat.
Not everyone can be an outlier.
I'm talking about averages.
Yes, there will be someoutliers.
(23:15):
I have done I taught a courseand created a video on Coursera
about Benjamin Franklin.
I think he's the most remarkableperson ever born in an America.
He was excelled at all sorts ofthings and he was an outlier.
Everyone talks about hisinventing bifocals.
He was 79 when he inventedbifocals.
(23:38):
Not many people are inventingsomething that sticks around for
250 years in their 79th yearand after that he still had more
inventions that you know aboutthe arm to lift up and grab
something from a high shelf.
Ben Franklin, he needed to grabhis books.
Anyway, he is a model, but notall of us are going to be like
(24:00):
that, and so we have to thinkabout what happens when we're
not going to be there, and thatwas the point of the book.
I told people my philosophy.
I wasn't saying everyone shouldadopt my philosophy, but
everyone should have aphilosophy and they should think
about a philosophy and theyshouldn't just have it come upon
them.
I don't particularly endorse,and I would argue with anyone
(24:25):
who has a sort of what I callthe Silicon Valley view of life,
which is I got to live forever.
What's the world going to be ifI die?
Yes, the world will continue, Ican guarantee that, and I think
trying to live forever is gotit.
You know, excuse me, but assbackwards.
Right, the point is to live arich life, right?
(24:47):
If you make the focus of yourlife living forever, there's no
content to it, there's nomeaning, 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 makethe world better, to make our
loved ones better people, tomake ourselves better people,
(25:08):
and not to just live forever.
Dr. Michael Koren (25:12):
Well, speaking of Benjamin Franklin,
there's a quote, I believe, frompoor Richard's Almanac that is
attributed to Ben Franklin, thatthe goal of life should be to
live well, not necessarily livelong.
So that gets your philosophy.
Although he did both, quitefrankly, he lived long and he
lived well.
But I'd also argue that thereare lots of people that make
amazing contributions well intotheir 70s, 80s and even 90s.
(25:35):
You look at people like WarrenBuffett.
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 insome ways better, and if I
extrapolate that, it should beworking 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 ifour views have changed.
But again, I think that we're awealthy country.
We can support people.
I think perhaps a little bitbeyond the 70s and quite frankly
, to your point.
Dr. Ezekiel Emanuel (26:12):
No, no, no, Wait, wait, wait, wait.
This is not about wealthycountries supporting people.
This is about your personalphilosophy.
It has nothing to do.
Even if you're magnificentlyrich, 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 treatmentsare performed at certain ages.
Dr. Ezekiel Emanuel (26:33):
Well, we know that in the United States
it's the same thing, even ifit's not a policy doctors, they
don't admit 80-year-olds withthe same thing as 70-year-olds
to the ICU, et cetera.
So I'm not sure I agree withthat.
Yes, we don't have a formalpolicy, but we have practices
that people have imbibed, andyou know it's anyway.
(26:57):
And my article is not aboutpublic policy.
It's very, very firmly inchallenging each of us to have a
personal philosophy about howwe want to live, how long we
want to live.
You know I ask this all thetime when I talk.
You know you want quantity oryou want quality of life.
Oh, we all want quality of life.
(27:17):
And then you talk to them andyou know they just haven't
thought through what that mightmean.
And when we get to that, youknow 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 anamazing conversation.
Thank you for being a guesthere on.
MedEvidence and it's been myabsolute pleasure and hopefully
we'll do it again very, verysoon and you can share some of
your amazing insights with us.
Announcement (27:55):
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Welcome to MedEvidence, where we help you
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Hosted by cardiologist and topmedical researcher, Dr.
Michael Koren.
Dr. Michael Koren (00:11):
We'll definitely have to bring you
back to dig into those reallyimportant questions in a much
more detailed manner.
Dr. Ezekiel Emanuel (00:17):
I have absolutely no hair.
Dr. Michael Koren (00:19):
Yeah, but I want to spend the rest of our
time together focusing on theethics part of the equation
right now, and we talked aboutthe Belmont Report and I've been
interested in that as well.
I'm a cardiologist and certainlysomebody that's done a lot of
research but also been reallyinterested in all these ethical
tensions that occur in theclinical research realm.
(00:41):
And, just for everybody'sknowledge, the Belmont Report
came out in 1979.
There are three overarchingprinciples, which is Autonomy,
or what we call respect forpersons and that's actually
changed over the years, which iskind of interesting and this is
the concept that all consentfor study should be free consent
and, for people who may nothave full autonomy or full
(01:03):
knowledge, that we help themappropriately.
Then we have DistributiveJustice, which is that the
burdens or the risks of researchcan fall on the same people all
the time.
And then we have Beneficence,which is our responsibility to
try to make all the researchstudies as beneficial as
possible and to reduce risk forthe patients as we design them.
So those are the three basicprinciples and the reason I'm
(01:26):
bringing those up is becausewe're super interested here in
MedEvidence of the concept ofresearch as a care option, and
you and I were just talkingabout before, when we say that
it's fundamentally differentthan research as a treatment
option.
So maybe I know that you'vedone some work in this area, so
maybe you can educate us alittle bit more on that
distinction.
Dr. Ezekiel Emanuel (01:47):
Well, this is actually one of those
interesting areas where, youknow, I looked at the Belmont
report and I thought, you know,and in 79, laying out those
three principles was veryimportant, but I think they
didn't get it quite right.
(02:07):
And part of what one of my mostfamous, most highly cited let's
put it that way, articles iswhat makes clinical research
ethical, and we delineated thatthere are seven principles that
you actually have to do.
One is there has to be socialvalue to the research.
You know, if you don'tdisseminate your results, if you
(02:30):
don't make them available, ifit's not answering an important
question, you shouldn't be doingthe research.
It's got to be scientificallyvalid.
Are you going to get it, areyou designed it to get it, A
real answer, because if you'redoing a randomized trial of 20
people and you know you don'thave some whopping big effect,
the data is going to be garbageand you can't put people at risk
(02:52):
for no scientific advance
Dr. Michael Koren (02:56):
Right.
Dr. Ezekiel Emanuel (02:57):
Third thing is to fit to, as you put it,
the distributive justice one.
You have to choose fairly thepeople who are going to
participate.
You can't say, for a superbeneficial study, heavily get
people who are well off orconnected to the board or
whatever, and for a highly riskystudy, get only people who are
(03:18):
minorities or low income or loweducation.
And then you know you have tohave a review, independent
review, because as researcherswe're always biased for our
research.
So you need an independentreview.
We have an IRB system.
Doesn't have to be that system,it does have to be independent.
And then you have to haveinformed consent.
(03:40):
And then we added the last one,which is look, people
participated in research.
You have to disseminate thatand you have to inform them what
was learned.
You can't just forget them.
So all of these are reallyimportant.
One of the things and again,you know, being trained as an
(04:01):
oncologist, it was sort of atthe Farber mother's milk that
you know that clinical researchis the best way to go and we
were always trying to see whythat people should get on
research studies.
And there are good reasons tothink about it.
(04:23):
It's standardized.
Some of the smartest people inthe world have worked on
developing a protocol so thatyou know you are getting good
standard of care and you'regetting all the right tests and
treatment.
And there's people looking atyour situation there's people
looking at the data to make surethat nothing's going awry.
(04:45):
So I think that there's a lotof positives there.
Actually, thinking about yourpoint that you made at the start
, I think you know it led me towrite a paper which I talked
about people's obligation toparticipate in research.
(05:06):
When the Belmont report waswritten, a lot of that was like
protecting people from research.
Why did we end up with theBelmont report and the whole
presidential commission?
Well, we ended up with itbecause of a scandal, the
Tuskegee scandal, and this wasthe response to the Tuskegee
scandal.
To try to make sure it wouldn'thappen again, we'd have
(05:28):
bioethicists thinking about allthe ethical issues and that
framework right.
Research is dangerous, researchis risky, research is going to
hurt people is what led to theBelmont report and the
regulations.
And my view is we, because ofthe Tuskegee, largely because of
the Belmont we did put in ainfrastructure, including IRB
(05:51):
review, including informedconsent, to protect people.
But once we had that structure,we could be pretty confident
that research was safe.
And again, it also meant thatall of us who take a pill every
day we're the beneficiaries ofthat research right.
(06:12):
That pill has been shown to besafe and effective and so we
benefit by someone else havingparticipated in the research.
I think that actually gives usan obligation as people to
actually participate ourselveswhen the opportunity presents
itself.
And I think we have.
(06:35):
We, the bioethicists, themedical community, spend so much
time trying to protect people.
We haven't thought about ourobligation to participate in
ethical research.
Now, it has to be ethical.
It has to have a risk benefitratio where the risks are
appropriate to the benefits.
It has to be that people arefairly selected, it doesn't
target one vulnerable group, etc.
(06:57):
But if it fulfills all that, wedo have, I think, an obligation
which we don't talk about inAmerica, very much.
We don't say it.
Dr. Michael Koren (07:07):
I think those are amazing points and I like
the emphasis on encouragingpeople to be part of research,
but not only for societalbenefit, but also for personal
benefit.
Dr. Ezekiel Emanuel (07:12):
Yeah I always think it's a 2-for-1.
It's good for you, but its goodfor people around you.
And by the way, since many ofthe things we research.
Have, you know, a familylineage relationship or raised
(07:34):
in the same environment.
You may in fact be benefitingyour family by what you do,
because you advance the scienceand knowledge of some condition
or disease or a genetic disorder, and that's all very, very
important, I think.
Dr. Michael Koren (07:50):
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 theaudience.
This is a study that started inthe 1930s let's look at the
natural history of syphilis whenthere really wasn't any
treatment for it, and this studycontinued for close to 40 years
(08:14):
until there was an expose inthe Washington Star that talked
about how this research wasgoing on and the men about 400
black men, who are uneducatedwere not told about their
participation in research, andthis happened for over 40 years,
and this is, of course, quitescandalous.
It's horrible, it wasexploitative, but there's
(08:35):
another side to it that'sinteresting.
One is that there was actuallya lot of learning from it.
So, while we've apologized tothese men that participate in
the study, we've never thankedthem for being in the study.
Thank you for allowing us tolearn, and we've never done that
, and I think that's a miss.
The other thing is that it's aninteresting dynamic between
(08:55):
racism and socioeconomic issues.
So the Tuskegee study wasactually performed at a
traditionally black university,tuskegee, and during the course
of this 40 years, the governmentwas very involved, by the way,
doing some horrible things, like, for example, when members of
the Tuskegee study group weredrafted into the military, they
(09:17):
were not allowed to getpenicillin shots because it
would mess up the study.
So that's just absolutelyhorrible.
But the government also was inconsultation with
African-American groups duringthis whole discussion.
So as late as 1969, the CDCevaluated the study and felt
like it should continue underthe current rules, including
(09:40):
consultation with blackphysicians.
So here again is this conceptthat has been, I think, somewhat
misunderstood by the generalpublic, that this was a
socioeconomic gulf between thephysician community, the medical
community and people who arenot educated.
And we've made a lot, a lot ofprogress, as you point out, with
IRBs and informed consent forms, et cetera.
(10:02):
In fact, if anything, we may begoing overboard, because when
you have a 35-page consent formthat changes every week, you're
not going to necessarily becommunicating with people that
have less than a higheducational level, and so, when
you think about these things,they're ways of excluding people
who are in lower socioeconomicclasses from participating in
(10:25):
something that's not onlyimportant for society but
important for them in terms ofboth direct and indirect
benefits, including being in amedical community, having really
good, ethical, smart peoplelooking out for you and then
knowing how to navigate thehealth system, because you have
somebody that's helping you in avery complex set of rules that
we all have to navigate.
So I don't know your reactionto that, but I'm curious to hear
(10:48):
it.
So I don't know your reaction tothat, 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 scientificknowledge, even in the '30's.
Because there was a fair amountof understanding of the natural
history of syphiis, and part ofthe idea was, well was a
natural history, and this iswhere I think some of the
racism, even at the start, camein: was the natural history
different in black men than inwhites.
And so I think there is somecontroversy on whether in fact,
from a scientific standpoint, itneeded to be done.
It was quite clear that whenpenicillin became widely
(11:31):
available and effective againstsyphilis, that it was
consciously and explicitlywithheld.
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 thewhole thing, easily 20 years,
maybe more, before the wholething ended, as you say, on an
expose by one of the staffmembers who was upset by the
situation.
It also did, as you point out,it was done in conjunction with
(12:04):
African-American leaders andphysicians in the community and
that you know that power dynamic, socioeconomic dynamic,
education dynamic I think wasproblematic and there was no one
who was necessarily looking outfor the sharecroppers who were
(12:30):
enrolled.
And I do think you know one ofthe problems that has resulted,
and I think you point out verywell, is you know we now have
this apparatus andinfrastructure to protect people
through IRB review and informedconsent and it's, you know, one
of the reasons I launched arevision of the regulations is
(12:52):
it's become encrusted, nothingsticking around.
And you point out one of them.
Our informed consent argumentsare way too long for what they
do.
They're written at an average11th grade level.
They have way too muchboilerplate.
It's part of the area I've donea fair amount of recent
(13:13):
research in getting back intothis 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 shortsentence.
We have worked with a couple ofdrug companies that are very
interested in trying to reducetheir informed consent form
(13:35):
text; and make it more readableand bring the age down of the
reading level down so that theycould get more people involved.
It does you know, when you havea big document like that, it
intimidates people, or theysimply ignore it and just trust
whatever they're told about itfrom the doctor or from the
(13:55):
nurse who is telling them aboutthe study.
That's not exactly what youwant.
Dr. Michael Koren (14:03):
Well, it sends the wrong impression.
So if it requires a 40-pagedocument for you to be in it,
you think, oh my God, this mustbe incredibly risky, what am I
signing up for?
And, quite frankly, there'sreally 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 anIRB that's well-functioning.
The main thing that they'rereally got to be entrusted with
is the risk-benefit ratio, theright risk-benefit ratio.
Do we have enough knowledge.
That's not to say you knowthings can turn out to be risky,
(14:39):
even though an IRB approvedthem.
That's why we're doing theresearch, because we don't know
the full measure of the risk orthe benefits.
But you have the value of anindependent group looking at
this and assessing the plusesand minuses of that research
study, by the way, which youdon't have in regular clinical
(15:02):
medicine.
Not everything in clinicalmedicine has been tested to the
degree that drugs have beentested.
That's one of the big problems,I think, is we have a very
uneven system.
The devices don't have to gothrough the same rigorous,
randomized, controlled trialsand things like that.
So I think we've overdone it inthe 45 years since the
(15:28):
regulations have been writtenand I think we need a fresh
examination.
But this is like many thingsonce you write it down and it
becomes institutionalized, itgets very hard to reform things
and people have sort of standardoperating procedures which are
not necessarily conducive.
(15:48):
And again, a lot of that isbuilt on the idea that, well,
research is really risky, well,life has got some risks and
we've got to put it all incontext, and that's actually one
of the things I've written alot about how do we compare the
risks of research with the risksof everyday life.
It turns out, given the risksof everyday life, turns out,
given the risks of everyday life, the big one for most adults,
(16:11):
driving.
The big one for kids otheraccidents, drownings, things
like that, and so playing sportsalso.
Dr. Michael Koren (16:24):
You're much safer in the research office
than you are out living in theworld.
Dr. Ezekiel Emanuel (16:27):
It's one of the important points and I
think we don't sufficiently makethat comparison.
Well, how risky is everydaylife?
We just assume, you know, webecome habituated to the risk.
Every time you put your key inthat 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 accidentevery year, and I forget all
(16:48):
the data, but it's not trivial.
Dr. Michael Koren (16:50):
Sure, no, absolutely so.
Would you have a family memberdo research?
Dr. Ezekiel Emanuel (16:55):
Oh, I do research.
So, um, um, my kids were raisedwith, uh, lots of talk about
medicine.
They went off to college, Everyone of them participated in
clinical research studies.
\I every year participate in aflu vaccine study.
They take out a large amount ofmy blood after the vaccine.
(17:18):
I participated in MRI studies.
I participated in studies aboutconcentration and shocks.
I even got that protocolchanged.
I'm not shy about talking up.
I've tried to get into avariety of cardiology studies
(17:38):
because I have a highcholesterol, 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 knowwe're all the beneficiary of
people who've enrolled inclinical 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'mmaking my small contribution to
making healthcare better in thefuture.
Dr. Michael Koren (18:15):
Yeah, and again, just to sort of reiterate
my point, when doctors talkabout treatment, it's what we
know, that you're getting aspart of a plan to create some
therapeutic benefit based onwhat we know or we think we know
, whereas in research we don'tknow that usually, and so what
we can provide is just thatbeing a part of a community
(18:37):
learning about your healthcondition, hopefully identifying
other things that may help youlive a better life, for both
yourself and your loved ones.
So, there's lots of elements ofcare that are separate from the
treatment elements, what we doas physicians.
Dr. Ezekiel Emanuel (18:52):
Absolutely.
I mean treatment's only one.
As you point out, treatment'sonly one very small part of what
medicine is about.
Dr. Michael Koren (19:00):
Absolutely, absolutely.
So, This has been a greatdiscussion.
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 yourselfprofessionally, and what maybe
you predict for us in terms ofthe research world?
Dr. Ezekiel Emanuel (19:17):
Well, I'm going to keep working, keep
writing.
I've got after the book I'mworking on right now.
I've got two more ideas, one ofwhich is about how to retire.
I think we do it Well.
One of the things I've becomevery interested in is the impact
(19:39):
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 useadvice about how to do it better
.
I think there are certainthings that we're discovering
that can, if you do it right.
One of the problems is we oftenjust retire instead of retire
(20:02):
with a plan.
I think everyone needs a planfor 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 forretirement.
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 havemisinterpreted that, but the
general interpretation is thatZeke Emanuel thinks you hit 75
and just hang it up and you goout to pasture and never come
back.
So maybe you can address thatstatement
Dr. Ezekiel Emanuel (20:39):
You're 100% right.
That's very wrong interpretation.
So the title of the article iscalled why I Want to Die at 75.
It was in the Atlantic 11 yearsago, in 2014.
As I like to tell people, youdon't, as an author, you do not
choose your title.
That is left to the editors andpublishers.
(21:00):
Your interest in accuracy andtheir interest in selling a lot
of magazines are not necessarilyconjoined, right, and this is
one where I did fight hard aboutthat title and I lost.
Yeah, my philosophy is that Idon't want life-saving like
(21:20):
cancer chemotherapy after 75.
I don't want an interventionwhere the purpose of the
intervention is to prolong mylife.
On the other hand, if you know,I was in it.
This happened to a friend ofours, which is why it's hot on
my mind.
But if I was in a ski line andsomeone came and barreled into
me and knocked me down and Ibroke my hip, I would want that
(21:41):
hip fixed.
If I get cataracts, I wantthose cataracts replaced, even
though they're not going to savemy life.
So I want to live a full life.
I think I'm still living apretty full life.
Uh, you know, two days ago Iwent out and rode 25 miles.
Yesterday rode 15 miles on mybicycle pretty good clip 17
(22:02):
miles an hour.
So, um, I'm very active and Itry to do new things.
This coming weekend I willharvest my honey from my
beehives.
So the problem at 75 is that ifyou look at the data, you know
cognitive decline goes up,alzheimer's risk goes up, you
(22:24):
know the wheels begin to comeoff the car, our functional
capacity goes down, we lose alot of muscle mass.
You have to consciouslymaintain your muscle mass.
I'm not planning to retire andhopefully cognitive decline
won't afflict me.
Um, but it does take um.
(22:55):
You know there is a a veryclear um inflection point at
about 75.
Is it true for everyone?
No, a lot of people say, well,if it were just 80?
well, yeah yeah, the fact is 75,when it goes up like a hockey
stick, um, and all of us thinkwe're going to be outliers.
I'm a little more sober aboutthat.
Not everyone can be an outlier.
I'm talking about averages.
Yes, there will be someoutliers.
(23:15):
I have done I taught a courseand created a video on Coursera
about Benjamin Franklin.
I think he's the most remarkableperson ever born in an America.
He was excelled at all sorts ofthings and he was an outlier.
Everyone talks about hisinventing bifocals.
He was 79 when he inventedbifocals.
(23:38):
Not many people are inventingsomething that sticks around for
250 years in their 79th yearand after that he still had more
inventions that you know aboutthe arm to lift up and grab
something from a high shelf.
Ben Franklin, he needed to grabhis books.
Anyway, he is a model, but notall of us are going to be like
(24:00):
that, and so we have to thinkabout what happens when we're
not going to be there, and thatwas the point of the book.
I told people my philosophy.
I wasn't saying everyone shouldadopt my philosophy, but
everyone should have aphilosophy and they should think
about a philosophy and theyshouldn't just have it come upon
them.
I don't particularly endorse,and I would argue with anyone
(24:25):
who has a sort of what I callthe Silicon Valley view of life,
which is I got to live forever.
What's the world going to be ifI die?
Yes, the world will continue, Ican guarantee that, and I think
trying to live forever is gotit.
You know, excuse me, but assbackwards.
Right, the point is to live arich life, right?
(24:47):
If you make the focus of yourlife living forever, there's no
content to it, there's nomeaning, 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 makethe world better, to make our
loved ones better people, tomake ourselves better people,
(25:08):
and not to just live forever.
Dr. Michael Koren (25:12):
Well, speaking of Benjamin Franklin,
there's a quote, I believe, frompoor Richard's Almanac that is
attributed to Ben Franklin, thatthe goal of life should be to
live well, not necessarily livelong.
So that gets your philosophy.
Although he did both, quitefrankly, he lived long and he
lived well.
But I'd also argue that thereare lots of people that make
amazing contributions well intotheir 70s, 80s and even 90s.
(25:35):
You look at people like WarrenBuffett.
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 insome ways better, and if I
extrapolate that, it should beworking 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 ifour views have changed.
But again, I think that we're awealthy country.
We can support people.
I think perhaps a little bitbeyond the 70s and quite frankly
, to your point.
Dr. Ezekiel Emanuel (26:12):
No, no, no, Wait, wait, wait, wait.
This is not about wealthycountries supporting people.
This is about your personalphilosophy.
It has nothing to do.
Even if you're magnificentlyrich, 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 treatmentsare performed at certain ages.
Dr. Ezekiel Emanuel (26:33):
Well, we know that in the United States
it's the same thing, even ifit's not a policy doctors, they
don't admit 80-year-olds withthe same thing as 70-year-olds
to the ICU, et cetera.
So I'm not sure I agree withthat.
Yes, we don't have a formalpolicy, but we have practices
that people have imbibed, andyou know it's anyway.
(26:57):
And my article is not aboutpublic policy.
It's very, very firmly inchallenging each of us to have a
personal philosophy about howwe want to live, how long we
want to live.
You know I ask this all thetime when I talk.
You know you want quantity oryou want quality of life.
Oh, we all want quality of life.
(27:17):
And then you talk to them andyou know they just haven't
thought through what that mightmean.
And when we get to that, youknow 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 anamazing conversation.
Thank you for being a guesthere on.
MedEvidence and it's been myabsolute pleasure and hopefully
we'll do it again very, verysoon and you can share some of
your amazing insights with us.
Announcement (27:55):
Thanks for joining the MedEvidence podcast.
To learn more, head over toMedEvidence.
com or subscribe to our podcaston your favorite podcast
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