November 12, 2025 • 33 mins
Dr. Evan Loh joins Dr. Michael Koren to discuss Dr. Loh's journey through the medical profession. Dr. Loh moved from doing lab work in medical school to patient care in the academic sphere and into the pharmaceutical world of research. Dr. Loh and Dr. Koren discuss the core differences between bedside physican work and research, including in time spent with patients, physician incentives, and the treatment that results. Through it all the doctors find a simple axiom: all medicine is about patients at the end of the day.
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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 bycardiologist and top medical
researcher, Dr.
Michael Koren.
Michael Koren, MD (00:11):
Hello, I'm Dr.
Michael Koren, the executiveeditor of MedEvidence! And one
of the really fun parts of myjob is I get to catch up with
old friends and talk about theirlives.
And gives me an opportunity totalk a little bit about my life,
but more interestingly, theguests' lives and how we have
interfaced over time.
And I had that greatopportunity today to interview
(00:32):
my friend and colleague, Dr.
Evan Loh.
And Evan and I caught up at arecent Harvard Medical School
reunion.
And when I was learning aboutwhat he was doing with his
career, I was really franklyblown away.
And I said, Evan, you got tocome to Med-Evidence and tell us
about your journey from uh whenI know you knew you back as a
medical student to becoming anacademic cardiologist to now
(00:55):
running a drug company.
So, Evan, welcome toMedEvidence! and uh share with
us um this incredible journey.
Evan Loh, MH (01:02):
Yeah.
Hey Michael, this is such atreat for me to be here with
you.
I'm delighted uh that we've hadeach other in our lives over
these many, many years.
It's hard, hard to even imaginethe uh the actual number of
years uh since we actually werein medical school together.
Michael Koren, MD (01:15):
That's a classified secret, my friend.
Evan Loh, MH (01:17):
It is a classified; I was not gonna
reveal that.
So uh a little bit ofbackground on me for for the
audience.
Um I am the uh firstborn uh sonof Chinese immigrants uh who
came here uh to the UnitedStates in uh 1955, uh, neither
(01:37):
of them speaking uh English,having to relearn English and
relearn their medicine.
My father was a physician andmy mom was a nurse, and trying
to figure out how to make aworld for themselves here in the
United States.
They didn't have family to goback to at that time.
There was a lot, a lot going onback there in Asia uh at the
time.
And um, you know, as being thefirstborn uh son in a
(01:59):
traditional Chinese householdthat we tried to make, um, there
was a big emphasis on trying tofigure out you know what was
going to be the uh career pathuh for uh for for this child.
And um I um did a lot ofthings.
I enjoyed every kind of sportuh possible.
I was the shortstop of mylittle league baseball team, and
(02:22):
uh I also played the violin andI was quite good at it.
You were incredible, by the way, andum just an aside uh for for the
audience, um we had a big showwhen we were second-year medical
students, and Evan actuallyopened the show playing the
violin from Fiddler on the Roofthat we turned into uh a bit of
a comedy sketch and was was morethan just good.
(02:43):
He uh maybe not quite avirtuoso, but pretty darn close.
Well, you're awfully kind, Michael.
I it was it was something thatI enjoyed then and continue to
play today in terms of enjoyingit, chamber music and what have
you.
Uh, but the um uh my motherquickly said, You can't have a
(03:04):
career as a musician.
Michael Koren, MD (03:05):
Really?
That was not okay.
Okay.
Evan Loh, MH (03:09):
So uh, and you know, the small world that I
lived in, you know, we I grew upin New Haven, and um, all of
the men and women that we had inour Chinese student circles,
uh, they were all either MDs orPhDs.
So there was a little bit ofpredestination in the sense that
my world was very narrow,Michael.
Uh so I think that uh on somelevel, medicine was preordained
(03:34):
or some pathway within themedical research field uh from
that perspective.
So um as I uh finished collegeand applied to medical school,
decided that was the path that Iultimately uh wanted to take,
um, I think that the pathwaydeviated a little bit from what
my parents knew, because myparents really, when they came
here, needed to basically getcertified to practice medicine.
(03:58):
And that was really their goalto have a career, to have a job,
and to be able to put a roofover our heads and uh support
our education.
But where I deviated a littlebit was the fact that I really,
by being at Harvard andsearching out opportunities to
actually open my mind up, got uminvolved with uh ongoing
medical research.
And so I did a senior thesis.
(04:18):
I did it at the Dana FarberCancer Institute.
Uh, we worked on uh fundamentalpathways of uh metabolism in
oncologic cells, and we had thechance to uh get those data
published, but I got exposed tothe fact that there's a real
opportunity to put translationaldata that you generate in cell
systems, even in mice systems orother animal systems, and apply
(04:41):
them to ask the question arethey relevant for human disease
and asking that particularquestion?
And so that was the backgroundupon which I went into medical
school.
And um, you know, when Michaeland I first met there, I don't
know whether you remember this,Michael, but we had a um
research mentor program for allfirst year HMS students.
(05:01):
And I think you mentioned maybeHarvey Feinberg was someone
that was close to you, but TomSmith, who was the chief of
cardiology at the Brigham.
Oh, wow, okay.
Was my first year mentor.
Very cool.
And uh so he brought me downinto the basement of the
Brigham, it's the new Brigham,showed me his, you know, his uh
uh dig antibody machine that hehad, the only person in the
(05:24):
world that could actually getdig antibodies and uh monitor
dig levels in the world.
Michael Koren, MD (05:29):
Right.
And um And for everybody,digoxin is a drug that we we've
used in cardiology for hundredsof years, literally.
For decades, yeah.
And and uh it was changing whenwe were in in school, but prior
to that, people would neverknow if if you were toxic from
dig or actually benefiting fromit.
That's right.
And this will get into ourevidence-based medicine
discussion, but we didn't evenknow the evidence for digoxin
(05:51):
until relatively recently.
But sorry for-
Yeah, that's right.
That's right.
And it's been controversial,actually, interestingly.
Yeah, sorry to interrupt it.
Uh yeah, a little aside.
Evan Loh, MH (05:59):
Then um it turns out that uh HMS had a program in
the in the summertime.
I don't know if you rememberthis.
You could apply as a student toactually do a medical research
project, and they would pay you.
Guess how much they paid, paidme?
$1,500 for 12 weeks of work.
Nice.
And it turns out that I uh dida research project in uh one of
(06:20):
Tom Smith's cardiology labs.
And um, it was um with JimMarsh, and um, we did work on
understanding uh calcium channeluh receptor physiology.
And so that was my start of myexposure to cardiology and uh
learning about that, and it'skind of stuck with me, Michael.
And so that's ultimately why II ended up uh you know going
(06:43):
into cardiology from thatstandpoint.
So um you and I graduated.
I went got my house stafftraining at the Brigham Internal
Medicine, did my cardiologythere, and got a transplant
fellowship as certificationthere uh at the Brigham, spent a
few years there, and ultimatelywent to the University of
Pennsylvania, where they askedme to run their cardiac
transplantation program, which Idid for about seven years or
(07:06):
so.
And uh we were able to growthat program to I think the
fifth largest volume hearttransplantation program in the
country.
Michael Koren, MD (07:12):
Wow.
And um had a lot of fun doingthat, built a giant program, uh,
a lot of fun.
And um, you know, it was at apoint where academic medicine,
this was back in 2000 or so,this is when academic medicine,
you know, had begun to have itsstruggles with understanding,
you know, how to actually runmedical centers.
Uh, they were trying toconsolidate primary care
(07:33):
practices, et cetera.
And I think the margins inthose businesses were hard.
And uh they really, you know,even though I had a
translational program where Iwas the clinical director and I
had to liaise with people thathad labs, um, you know, that was
not the commodity that theyvalued, Michael.
They really valued my RVUs,they wanted me to be busier, and
(07:54):
uh, that's what they valued atthat time.
Yeah, it was a very for the audience, RVUs
are relative value units, andthat doctors get paid in a lot
of settings based on how manyvisits they do or how many
procedures they do based on thisRVU matrix.
Evan Loh, MH (08:08):
But good, yeah.
And and so, you know, eventhough we had fellows and lots
of research going, uh, I'dpublished, you know, a hundred
plus papers, written a book, etcetera.
That was not really what theyvalued, which was disappointing
to me.
And I wanted to actually askmyself, where else could I go to
actually think about being inthat translational space where I
(08:30):
could apply interesting basicscience knowledge, translate it
into animal models, andultimately think about how it
could continue to be a positiveoutcome for improving and
advancing uh clinical care.
Because I'd done some of thatwork, you know, when I was a
cardiologist.
You read some of my papers interms of being the first person
(08:52):
to publish the effects of thebeneficial effects of warfarin
in patients with heart failure,secondary to myocardial
infarction, and other thingsalong those lines.
So it turned out that I made abig transition.
I put a I left academicmedicine and I joined a uh large
uh pharmaceutical companycalled Wyeth, been stayed there
for about nine years, developeda bunch of different uh
(09:14):
medicines, and then uh we wereacquired by Pfizer.
And um, after being there for acouple of years, I really
wanted to get out and go on goon my own and wanted to get back
to drug drug development.
And um ultimately um landedhere at my company called
Paratech.
This is uh back about oh, 13years ago, and we've been able
(09:35):
to get the company public uhafter being private, and then
now we're private again, butraised a ton of capital,
probably about a billion and ahalf dollars worth of capital in
about 12 years to get to thepoint where we actually have two
approved products in ourportfolio, and we are
commercially uh out in themarketplace with our two drugs.
(09:57):
One is an broad spectrum nextgeneration uh tetracycline, and
then the other product is a newmed device combination with a uh
next generation flonase forpeople with chronic sinusitis
with and without nasal polyps.
And so um we're moving alongand we're having a good time,
but it's you know one of thoseplaces where um, you know, as I
(10:18):
hearken back to something that Ilearned when I transitioned
into uh pharma, you know, we hadum, you know, I was a I was a
thought leader, Michael, hadpublished a lot of papers, and
you know, there's academicianswho think they're really
important.
And um, I get into thepharmaceutical world, and uh my
head of clinical research anddevelopment at Wyatt sat me down
(10:41):
and said, Look, I just want tolet you know, and this is what
I've seen before in the past, hesaid, you know, when academics
come into pharmaceutical land,they think they're really
important.
But at the end of the day, noone really cares.
All they care about is thatyou're focused on doing great
drug development and helpingthem be successful.
And that was really a soberingmoment for me.
(11:01):
You know, it was kind ofhumbling in some sense because I
didn't really understand howdrug development has to work,
which is in a team setting.
You know, one of the thingsthat I like to say in my company
is that no one in my companyhas a monopoly on intelligence.
And you need to bring ideasfrom everybody in order to have
successful drug developmentbecause people come from
different places, they havedifferent different levels of
(11:22):
experience.
Michael Koren, MD (11:23):
Right.
Evan Loh, MH (11:24):
And, you know, when I and another theme that I
had that I learned that I stillthink about today is that the
head of our commercial businessalso said, you know, you you
guys here can really spend a lotof time thinking about
transformational changes, makingthe company more efficient,
thinking about doing it withless heads, blah, blah, blah,
blah, blah.
But you know what?
There are no great, there areno great pharmaceutical
(11:47):
companies on this planet.
There are only companies thathave great products.
Focus on the great products.
And that was really a themethat I continue to believe in
today that's really, reallyimportant.
And what are those greatproducts, Michael?
You know, I know that you'reyou're in this field, you've
been in your in this field fordecades, leading uh clinical
(12:07):
trial development, clinicaltrial protocol development,
living in the regulatory world.
At the end of the day, it'sit's a mix, right?
One is that it has to make adifference in a patient's life
in a way that's reallyobjective, demonstrable,
measurable, that a regulator cansee, say yes to.
But at the end of the day, it'sgot to be something that a
doctor is going to care about.
And then finally, I think theother piece that I think
(12:30):
pharmaceutical companies cansometimes lose their way, and it
speaks to the value of I thinkbeing a physician in this
particular field, is just alwaysrespecting and honoring a prima
facie commitment to patientsafety.
Always because you're askingthem to take a potential drug or
an antibody or a vaccine thatcould ultimately hurt them.
(12:52):
And you and I know that thelast thing that we want to ever
have at the patient's bedside isthat we do something or make a
recommendation that the outcomeis less than less than perfect.
And I know nature, nature andmedicine are humbling every day.
We do our best based upon theinformation we have, but we
don't want to activelyparticipate with a company or a
(13:13):
product that ultimately has ahigher risk of actually hurting
someone than making them better.
Michael Koren, MD (13:19):
Yeah, you you said so many incredible things
in in that little discussion anda lot of stuff to unpack.
So I'm gonna uh in noparticular order.
Uh one of the things that yousaid that resonated with me was
this trade-off between theclinical care and the RVU
environment where you're beingvalued based on what you do for
(13:43):
one patient at a time, which isimportant, versus research,
which impacts thousands ofpeople at a time.
And it reminds me of adiscussion I had with my
cardiology fellowship mentor,Dick Devereux.
I don't know if you ever workedwith Dick, but he was he was my
mentor at Cornell duringcardiology fellowship.
And he he kind of drove thatidea into my head in a big way.
(14:06):
He said, You're you know,clinical care is important, but
let's face it, you're affectingone person at a time.
Whereas in the research world,you're literally affecting
thousands or millions of peoplebased on the work you're doing.
And that that always reallyresonated with me.
And I think you had that thatDNA as well.
Uh and and and interestingly,you kind of made the path to
(14:27):
industry in part to pursue thatDNA, if you will.
Evan Loh, MH (14:31):
Yeah, I think that's right.
I think you you hit it right onthe head.
People have asked me, you know,you had such a great career uh
in academia and in cardiology,why'd you leave?
I said, well, in some regards,it was it was unbelievable in
terms of my experience, justlike yours, when you were
actively and you may still beseeing patients, I think one day
a week, uh, to make thatdifference one patient at a
(14:54):
time.
I think though, where the wherethe rubber met the road for me
is that I was getting pulled soheavily into the clinical arena
that I couldn't actually havethe time to think about
fundamental research questionsthat would advance the field and
make patients' lives better.
And I hoped when I moved intothe pharma world that number
(15:15):
one, the science was good, andnumber two, that they that they
were asking good fundamentalquestions that could advance the
care of patients.
And I think that's part of theI think that's part of the
subtlety, Michael, that folksdon't really appreciate that the
science in the pharmaceuticalresearch world and the biotech
world is top shelf.
Michael Koren, MD (15:33):
Yeah, oh no doubt.
Evan Loh, MH (15:34):
Uh it's really top shelf with top shelf
scientists, top shelfresearchers.
I mean, you can't really gointo clinical trials and give
patients these medicines unlessyou've really understood the
products.
And and I've learned so muchthat I'd never learned in
medical school, which ispharmacokinetics,
pharmacodynamics, drugmetabolism, conversions.
(15:56):
I had to go back to my Krebscycles, I had to go back to my,
you know, all yeah, all of it'srelevant.
Michael Koren, MD (16:02):
No, no doubt.
And absolutely.
And and and uh And it's fun touse that stuff. Yeah, it it's
fun to say, oh, I I did studythis when I was a first-year
medical student, and now I seethe relevance after all these
years.
Yeah.
So that is fun.
So I want to also focus onsomething else you said that I
think is really compelling,which is the role of the
(16:24):
physician in drug developmentand how there's a centricity
around the patient and safetywhen we do what we do, that's
probably fundamentally differentthan non-physician researchers.
So maybe you can comment alittle bit more on that.
Evan Loh, MH (16:41):
Yeah, you know, if you think about, you know, if
you think about the predominantpercentage of people that are in
pharmaceutical drugdevelopment, I would say 98% of
them are actuallynon-physicians.
And if you look at theleadership of these
organizations, because they haveto survive, right?
And they have to be, you know,profitable, most of the senior
(17:03):
leaders are actually commercialcommercially driven or from the
finance world.
And so they've never been atthe bedside.
And I do think that there'salso some bias that clinicians
in the pharmaceutical drugworld, drug development world,
are really only good for safetyto evaluate patient safety,
which is great.
They understand that there's noone else can that can actually
(17:25):
do that because then they've notbeen at the bedside.
But I think where that thatassumption goes awry, Michael,
you know, and you and I weretalking about this earlier, is
that I don't think that anyoneelse has really been at the
bedside to understand how aclinician thinks, how they might
use a new medicine, what theirdeterminants of what a good
outcome would be for a patientwith disease X or Y.
(17:49):
And I think that's where Ithink physicians that have the
ability to navigate through thecomplexities of the science, the
translation, the clinicaldevelopment data, as well as on
the commercial side andmarketing side, to be able to
blend those together, I thinkphysicians have an incredibly
important role because we're theonly ones that have ever been
at the bedside.
(18:10):
And I think that one of the oneof the pieces of feedback that
I re that I get veryconsistently, that I'm very
pleased about in my currentcompany, by being a physician
who's the CEO.
I talk about patients everytime I talk publicly with my
company.
Patients are always front andcenter.
Patient safety always is numberone, Michael.
(18:31):
I know you believe in that interms of everything that we do,
but the products that weultimately have.
I asked all of my employees atthe end of the day, if it's your
mother, father, brother,sister, grandmother,
grandfather, would this actuallybe a product that you would
feel comfortable giving to yourmother, father, brother, sister,
grandmother, grandfather?
Michael Koren, MD (18:51):
I love that.
Evan Loh, MH (18:51):
So it is about patient safety.
And so by doing that, you know,everyone in the company comes
up to me and they say, Wow, it'sso great to have a physician
leading this company because Iunderstand who we are fighting
for.
We are fighting for ourpatients.
And that's really the themethat I like to carry through in
my current leadership role.
And I don't think it's anydifferent, Michael, than why I
went to medical school, which iskind of odd because you know,
(19:15):
I'm not actually at the bedside,but I patients are front and
center because they have to be.
Otherwise, otherwise, themission is actually off point.
Michael Koren, MD (19:26):
Yeah, well said.
So that that gets me to sort ofuh the last point I wanted to
drill down with you on, which isthis concept of what is
evidence-based medicine andparticularly how patients could
fit into that.
And as you know, we've had thisdiscussion previously, but kind
(19:46):
of my career path has beenaround not only looking at the
outcomes of the studies that wedo, but also thinking about what
that experience was for allthese patients, and why that's
such a fulfilling experience anda valuable experience for
patients.
And of course, I've I've builtan organization around that to
give patients the opportunity tohave those experiences.
(20:08):
But I think there's a lot ofmisconceptions about what
evidence-based medicine is,first of all, and then secondly,
why it's so attractive for forpatients, for people to get
involved in this process.
So maybe share some of yourthoughts on that.
Evan Loh, MH (20:22):
Yeah, look, I think that they're, you know,
there, if you look at thehistory of clinical research,
right, you can go back to theTuskegee experiments and other
things that you know have givenit a bad name.
And I think that things havereally come a long way.
You know, if you look at theDeclaration of Helsinki and uh
the International Committee onHarmonization of Clinical Trial
(20:46):
Development or ICH, they arefundamental oversight bodies
that we ascribe to, we committo, and that we live by to
ensure that patients, whenthey're asked to participate,
there's no coercion, thatthey're actually in a place
where the experience is actuallyshould be in some ways no
different than getting routineclinical care.
(21:06):
And that in fact we try tominimize the amount of abuse of
in terms of uh blood draws orother procedures or other you
know x-rays or other things.
Michael Koren, MD (21:18):
Data collection.
We won't we won't call itabuse, we'll call it data
collection.
Evan Loh, MH (21:21):
Yeah, I think abuse is not the right word for
it, but um, thank you for that.
But I think it's really theamount of data collection.
Right.
And I think that there's also amoral contract that you develop
with these patients or evenknown volunteers who participate
in pharmacokinetic studies toask them to actually
participate, is that I thinkthat they're what what what I
(21:44):
think you've experienced as wellas I've experienced is that
there is a deep-seated level ofaltruism that humans actually
have.
Yeah, that they say, you knowwhat, it may not be good for me,
but if this is data that yousay could lead to this
improvement or this new medicinehelping this cohort of
individuals down the road, I'mall in.
Yeah, I'm all in to help you.
(22:05):
Yeah.
And and I just continue to justtip my hat to to all of those
patients who say yes.
And when they say yes, I alsosay to my folks that are working
on my side, remember whatthey've said yes to.
And we have an absoluteobligation to transparency, to
(22:27):
treat them well, to let them beable to say that I'm done.
I don't want to participateanymore, to give them complete
freedom to, you know, determinetheir pathway, and at the end of
the day, interact with theirphysicians in a way that at the
right time they can also sharethe outcomes of the trial with
them so that they know what theyparticipated in.
So I think that there's athere's a full circle here,
(22:48):
Michael, as you said, in termsof their participation to
generate these data.
Michael Koren, MD (22:52):
Yeah-
But in the absence of thesedata, we don't get life-saving
cancer drugs, we don't getlife-saving cardiovascular
drugs, we don't get life-savingdrugs that, you know, change the
natural history of people withrheumatoid arthritis.
You remember the days when wewere at the Brigham where these
elderly patients would come inin wheelchairs with deformed
joints, their hands, their legs,they couldn't walk.
(23:14):
You know, today medicalstudents don't see that type of
rheumatoid arthritis.
Yeah, so interesting.
Evan Loh, MH (23:19):
Right?
And it's because of theproteins that we've developed,
the Enbrels and the Humiras andthings like that, the disease
has completely changed.
I mean, uh and I just am soexcited to be part of this uh
industry.
I mean, think about the naturalhistory of cystic fibrosis,
right?
Uh they used to all uh perish,you know, in their late teens.
Today, uh the natural historyof patients with cystic
(23:42):
fibrosis, because of theinterventions and the places
that uh these these new drugshave gone.
64 years, Michael.
Is the life expectancy of apatient with cystic fibrosis.
Michael Koren, MD (23:52):
Amazing.
Evan Loh, MH (23:53):
Five more decades of life.
I mean, that's amazing, right?
Michael Koren, MD (23:57):
It's it's it's absolutely fabulous.
It's absolutely fabulous.
And so you know, uh, we used toum compare notes all the time
at at the different cardiologymeetings when you were uh uh
running the heart failureprogram at Penn.
I remember we we had somediscussions, and obviously you
were doing you were gettingpeople in clinical trials that
were really, really sick.
And um, you know, in though inthat case, a lot of the people
are really doing it to see ifthey can improve their survival.
(24:20):
But there's so many otherelements of participation that
people love.
Uh and my favorite statistic toquote is when you ask an
average American or averageEuropean who's never been
exposed to clinical researchwhether or not they're
interested in being involved ina clinical trial, only 40% say
yes.
But if you ask somebody that'scompleted a research study, if
(24:43):
you would do a second study, 97to 99% of people say yes.
And the reason that there'sthat high conversion rate to
being true believers and fans inthe process is because they get
so many things.
They get the socialization, theintense interaction with the
staff and the physicians, whichas you alluded to, is not really
(25:03):
part of clinical medicinenowadays.
Everything has become sort ofcookbook and and just
processing.
And the the human touch hasbeen unfortunately extracted a
lot from from clinical medicine,but you still get that in
research, ironically, when youthink about it.
And uh, of course, there's alot of information that's shared
with the patients.
Uh people get imaging teststhat they might not get, people
(25:25):
get uh treatments that they mayor may not get, although we are
always very clear that sometimeswe don't know what you're on,
and sometimes it can be aplacebo.
But and and there's alsostipends.
People in many cases get paidfor their time in travel.
That is helpful for a lot ofpeople.
It could be the difference uhbetween uh not a great Christmas
and having more money for giftsfor for the family.
So you know these are practicalthings that really impacted a
(25:47):
lot of our patients.
But you brought up the thingthat I think is the most
compelling, which is at the endof the day, we get these results
that change the world.
And people love that.
Uh and and it it could changethe world for that generic
person out there, or it canchange the world for a family
member because it's a geneticdisease that we're learning
(26:08):
about.
And and so to me, this is whatfloats my boat.
This is what gets me excited.
And um, you know, this is theexperiential part of
evidence-based medicine.
And then there's one other partthat I don't think people
understand that well, and I'dlove to hear your comments on
that, which is, and we kind ofalluded to it in some of our
stories, but you know, 50 yearsago, the way physicians worked
(26:32):
was kind of, okay, well, myfriend, the oncologist, tried
this and maybe we'll try it, uh,versus what we do now, which is
when we actually use a medicinethat's been approved, we know a
lot about it.
And we talked about digoxin,which is probably the oldest
cardiac drug.
Uh uh aspirin may have been theoldest cardiac drug we didn't
even know it was a cardiac drugfor many years.
Evan Loh, MH (26:53):
No, that's right.
But digoxin has been somethingthat's been uh used by
physicians for over 200 years,and it was only in the last 20
years or so where we actuallyhad a study to show that it kind
of worked, but maybe not asmuch as we thought.
So this whole concept of justassuming that the physician has
all this information versusactually having the information
(27:17):
is a fundamental transformativemedicine uh transformative part
of evidence-based medicine.
But your your reaction to that.
I I think it's spot on.
It's it it is, I think when youlook at evidence-based
medicine, Michael, I think youcan you can take it to one
extreme, which is that if youdon't have the evidence, you
can't use it.
However, I think that there isa gradient of of data that
(27:44):
actually you can couple togetherwith your bedside experiences
to ultimately have you decidewhat's what's best at the end of
the day.
I think that you know, wherethings have gone a little
sideways recently is uh notreally understanding or
appreciating how hard it is togenerate those studies.
(28:06):
And when you look at theanalytics that go along with it,
how important they are to, Ithink being able to answer a
fundamental clinical question.
And number two, I think howdoes it ultimately get applied
in the clinical care?
Because as you know, sometimesthese clinical trials are
designed in ways where you haveto try to get as pure a
(28:27):
population as possible to beable to have that intervention
be the one thing that you couldactually determine was making
the difference, as opposed toputting it in the context of a
clinical care algorithm whereyou actually may have other
drugs in the mix at the time.
But the regulators and alsoclinicians want to see the
effect of that one drug asopposed to that in combination.
(28:51):
Those those data come later,uh, but it's one of those things
where I think it really is veryhelpful.
And I think when you go back toour training and you think
about some of the some of thetrials that we looked at, right?
Such as the natural history ofuntreated aortic stenosis, you
know, from Eugene Braunwald, oryou know, the uh outcome of
(29:14):
low-gradient aortic stenosis andLB dysfunction, right?
That Blase Carabello study wasdone in like 20 patients.
I mean, that's what we basedour practice on, was just what
was published, right?
I mean, it was the best we hadat that time.
But now you're you're talkingabout trials that have tens of
thousands of patients of data,like you said.
(29:35):
We really do know that thesedrugs, number one, are
fundamentally safe, or theyhave, you know, a risk of
diarrhea or nausea or or whathave you.
But at the end of the day, wecan actually be able to
actually, in a very, veryaccurate way, tell the clinician
exactly what they couldpotentially expect on a
population basis for the effectsize.
Michael Koren, MD (29:56):
Absolutely.
Absolutely.
And you you brought upsomething that's interesting.
Is again, it's the balancebetween some of the clinical
aspects and the scientificaspects.
And all the things that we doin evidence-based medicine is
built on these protocols, but itdoesn't take away our
commitment to the patients anddoing the right thing for the
patient.
I'll give you a recent exampleof that.
So, as you know, I've done alot of work in the lipid world,
(30:19):
and we've done a lot of uh earlyphase clinical trials here in
Jacksonville, and we had apatient last year who was in for
a very early phase lipid study,which involved confinement for
seven days here in our offices.
And um, very nice guy.
Um, probably not somebody thatwas interacting with the
standard medical profession asmuch as he should, had multiple
(30:41):
cardiovascular risk factors, butactually no known actual heart
disease.
And he's in a lipid study, andhe, you know, starts to get a
little angina when he's herewith us.
Okay.
And um, because of the factthat we're, you know, even
though we have a protocol thatdoesn't really evaluate angina,
of course, for the safety of thepatient, we do what's
(31:02):
necessary.
And then we find he has alittle troponin bump, which
means that he had some damage tohis heart muscle.
And uh so uh literally we gothim from our confinement area to
the cath lab, which is ofcourse not part of the protocol
at all, but this is what we needto do for the patient.
And he had a very seriousobstruction of his coronary
(31:23):
artery that we fixed.
And um uh and so he comes backuh after that, and you know, I
didn't know how he was gonnareact to the whole thing.
You know, would he blame thestudy for this whole thing?
And Evan, he was so thankful.
He literally thanked me forsaving his life because you know
he said, you know, I Iunderstand that if it wasn't for
(31:43):
this study, I would not havehad that experience.
And even though I did end uphaving a small heart attack, it
turns out you would have neverknown this problem and you
literally saved my life.
And so it's an example of inthe uh in the process of
creating evidence-based medicinefor a new lipid drug, we
actually had a huge impact onsomebody's life.
(32:03):
And and and again, this is tome why it's so important what we
do.
And and and you've touched thisspace in so many places during
your career from being a medicalstudent and drawing blood on
people to uh to running a heartfailure clinic and now actually
running a drug company thatfinds the funds and finds the
logistics to actually run thesestudies across the world.
(32:25):
So again, congratulations andthanks for everything that you
do.
Evan Loh, MH (32:30):
Look, Michael, thanks, thanks for that.
I I love that story.
And you know, at the end of theday, and I know you care deeply
about eviden evidence-basedmedicines, but you know, what I
like to say, you know, is thatat the end of the day, data's
forgotten, but stories areremembered.
And what are we in the businessof?
We're in the business ofgenerating great patient
stories.
And that through line has notchanged a whit from our time in
(32:53):
medical school to today.
And I'm just honored andprivileged to have been part of
this industry and making adifference in patients' lives
each and every day.
Michael Koren, MD (33:04):
Well, that was a brilliant way to end our
discussion, and I want to thankyou for being part of
MedEvidence! and thank you forspending some time with us.
And um, this has been a truepleasure for me.
Thank you, Evan.
Evan Loh, MH (33:15):
Tons of fun, Michael.
Thank you so much.
Announcement (33:17):
Thanks for joining the MedEvidence Podcast.
To learn more, head over toMedEvidence.com or subscribe to
our podcast on your favoritepodcast platform.
Welcome to MedEvidence, where we help you
navigate the truth behindmedical research with unbiased,
evidence-proven facts, hosted bycardiologist and top medical
researcher, Dr.
Michael Koren.
Michael Koren, MD (00:11):
Hello, I'm Dr.
Michael Koren, the executiveeditor of MedEvidence! And one
of the really fun parts of myjob is I get to catch up with
old friends and talk about theirlives.
And gives me an opportunity totalk a little bit about my life,
but more interestingly, theguests' lives and how we have
interfaced over time.
And I had that greatopportunity today to interview
(00:32):
my friend and colleague, Dr.
Evan Loh.
And Evan and I caught up at arecent Harvard Medical School
reunion.
And when I was learning aboutwhat he was doing with his
career, I was really franklyblown away.
And I said, Evan, you got tocome to Med-Evidence and tell us
about your journey from uh whenI know you knew you back as a
medical student to becoming anacademic cardiologist to now
(00:55):
running a drug company.
So, Evan, welcome toMedEvidence! and uh share with
us um this incredible journey.
Evan Loh, MH (01:02):
Yeah.
Hey Michael, this is such atreat for me to be here with
you.
I'm delighted uh that we've hadeach other in our lives over
these many, many years.
It's hard, hard to even imaginethe uh the actual number of
years uh since we actually werein medical school together.
Michael Koren, MD (01:15):
That's a classified secret, my friend.
Evan Loh, MH (01:17):
It is a classified; I was not gonna
reveal that.
So uh a little bit ofbackground on me for for the
audience.
Um I am the uh firstborn uh sonof Chinese immigrants uh who
came here uh to the UnitedStates in uh 1955, uh, neither
(01:37):
of them speaking uh English,having to relearn English and
relearn their medicine.
My father was a physician andmy mom was a nurse, and trying
to figure out how to make aworld for themselves here in the
United States.
They didn't have family to goback to at that time.
There was a lot, a lot going onback there in Asia uh at the
time.
And um, you know, as being thefirstborn uh son in a
(01:59):
traditional Chinese householdthat we tried to make, um, there
was a big emphasis on trying tofigure out you know what was
going to be the uh career pathuh for uh for for this child.
And um I um did a lot ofthings.
I enjoyed every kind of sportuh possible.
I was the shortstop of mylittle league baseball team, and
(02:22):
uh I also played the violin andI was quite good at it.
You were incredible, by the way, andum just an aside uh for for the
audience, um we had a big showwhen we were second-year medical
students, and Evan actuallyopened the show playing the
violin from Fiddler on the Roofthat we turned into uh a bit of
a comedy sketch and was was morethan just good.
(02:43):
He uh maybe not quite avirtuoso, but pretty darn close.
Well, you're awfully kind, Michael.
I it was it was something thatI enjoyed then and continue to
play today in terms of enjoyingit, chamber music and what have
you.
Uh, but the um uh my motherquickly said, You can't have a
(03:04):
career as a musician.
Michael Koren, MD (03:05):
Really?
That was not okay.
Okay.
Evan Loh, MH (03:09):
So uh, and you know, the small world that I
lived in, you know, we I grew upin New Haven, and um, all of
the men and women that we had inour Chinese student circles,
uh, they were all either MDs orPhDs.
So there was a little bit ofpredestination in the sense that
my world was very narrow,Michael.
Uh so I think that uh on somelevel, medicine was preordained
(03:34):
or some pathway within themedical research field uh from
that perspective.
So um as I uh finished collegeand applied to medical school,
decided that was the path that Iultimately uh wanted to take,
um, I think that the pathwaydeviated a little bit from what
my parents knew, because myparents really, when they came
here, needed to basically getcertified to practice medicine.
(03:58):
And that was really their goalto have a career, to have a job,
and to be able to put a roofover our heads and uh support
our education.
But where I deviated a littlebit was the fact that I really,
by being at Harvard andsearching out opportunities to
actually open my mind up, got uminvolved with uh ongoing
medical research.
And so I did a senior thesis.
(04:18):
I did it at the Dana FarberCancer Institute.
Uh, we worked on uh fundamentalpathways of uh metabolism in
oncologic cells, and we had thechance to uh get those data
published, but I got exposed tothe fact that there's a real
opportunity to put translationaldata that you generate in cell
systems, even in mice systems orother animal systems, and apply
(04:41):
them to ask the question arethey relevant for human disease
and asking that particularquestion?
And so that was the backgroundupon which I went into medical
school.
And um, you know, when Michaeland I first met there, I don't
know whether you remember this,Michael, but we had a um
research mentor program for allfirst year HMS students.
(05:01):
And I think you mentioned maybeHarvey Feinberg was someone
that was close to you, but TomSmith, who was the chief of
cardiology at the Brigham.
Oh, wow, okay.
Was my first year mentor.
Very cool.
And uh so he brought me downinto the basement of the
Brigham, it's the new Brigham,showed me his, you know, his uh
uh dig antibody machine that hehad, the only person in the
(05:24):
world that could actually getdig antibodies and uh monitor
dig levels in the world.
Michael Koren, MD (05:29):
Right.
And um And for everybody,digoxin is a drug that we we've
used in cardiology for hundredsof years, literally.
For decades, yeah.
And and uh it was changing whenwe were in in school, but prior
to that, people would neverknow if if you were toxic from
dig or actually benefiting fromit.
That's right.
And this will get into ourevidence-based medicine
discussion, but we didn't evenknow the evidence for digoxin
(05:51):
until relatively recently.
But sorry for-
Yeah, that's right.
That's right.
And it's been controversial,actually, interestingly.
Yeah, sorry to interrupt it.
Uh yeah, a little aside.
Evan Loh, MH (05:59):
Then um it turns out that uh HMS had a program in
the in the summertime.
I don't know if you rememberthis.
You could apply as a student toactually do a medical research
project, and they would pay you.
Guess how much they paid, paidme?
$1,500 for 12 weeks of work.
Nice.
And it turns out that I uh dida research project in uh one of
(06:20):
Tom Smith's cardiology labs.
And um, it was um with JimMarsh, and um, we did work on
understanding uh calcium channeluh receptor physiology.
And so that was my start of myexposure to cardiology and uh
learning about that, and it'skind of stuck with me, Michael.
And so that's ultimately why II ended up uh you know going
(06:43):
into cardiology from thatstandpoint.
So um you and I graduated.
I went got my house stafftraining at the Brigham Internal
Medicine, did my cardiologythere, and got a transplant
fellowship as certificationthere uh at the Brigham, spent a
few years there, and ultimatelywent to the University of
Pennsylvania, where they askedme to run their cardiac
transplantation program, which Idid for about seven years or
(07:06):
so.
And uh we were able to growthat program to I think the
fifth largest volume hearttransplantation program in the
country.
Michael Koren, MD (07:12):
Wow.
And um had a lot of fun doingthat, built a giant program, uh,
a lot of fun.
And um, you know, it was at apoint where academic medicine,
this was back in 2000 or so,this is when academic medicine,
you know, had begun to have itsstruggles with understanding,
you know, how to actually runmedical centers.
Uh, they were trying toconsolidate primary care
(07:33):
practices, et cetera.
And I think the margins inthose businesses were hard.
And uh they really, you know,even though I had a
translational program where Iwas the clinical director and I
had to liaise with people thathad labs, um, you know, that was
not the commodity that theyvalued, Michael.
They really valued my RVUs,they wanted me to be busier, and
(07:54):
uh, that's what they valued atthat time.
Yeah, it was a very for the audience, RVUs
are relative value units, andthat doctors get paid in a lot
of settings based on how manyvisits they do or how many
procedures they do based on thisRVU matrix.
Evan Loh, MH (08:08):
But good, yeah.
And and so, you know, eventhough we had fellows and lots
of research going, uh, I'dpublished, you know, a hundred
plus papers, written a book, etcetera.
That was not really what theyvalued, which was disappointing
to me.
And I wanted to actually askmyself, where else could I go to
actually think about being inthat translational space where I
(08:30):
could apply interesting basicscience knowledge, translate it
into animal models, andultimately think about how it
could continue to be a positiveoutcome for improving and
advancing uh clinical care.
Because I'd done some of thatwork, you know, when I was a
cardiologist.
You read some of my papers interms of being the first person
(08:52):
to publish the effects of thebeneficial effects of warfarin
in patients with heart failure,secondary to myocardial
infarction, and other thingsalong those lines.
So it turned out that I made abig transition.
I put a I left academicmedicine and I joined a uh large
uh pharmaceutical companycalled Wyeth, been stayed there
for about nine years, developeda bunch of different uh
(09:14):
medicines, and then uh we wereacquired by Pfizer.
And um, after being there for acouple of years, I really
wanted to get out and go on goon my own and wanted to get back
to drug drug development.
And um ultimately um landedhere at my company called
Paratech.
This is uh back about oh, 13years ago, and we've been able
(09:35):
to get the company public uhafter being private, and then
now we're private again, butraised a ton of capital,
probably about a billion and ahalf dollars worth of capital in
about 12 years to get to thepoint where we actually have two
approved products in ourportfolio, and we are
commercially uh out in themarketplace with our two drugs.
(09:57):
One is an broad spectrum nextgeneration uh tetracycline, and
then the other product is a newmed device combination with a uh
next generation flonase forpeople with chronic sinusitis
with and without nasal polyps.
And so um we're moving alongand we're having a good time,
but it's you know one of thoseplaces where um, you know, as I
(10:18):
hearken back to something that Ilearned when I transitioned
into uh pharma, you know, we hadum, you know, I was a I was a
thought leader, Michael, hadpublished a lot of papers, and
you know, there's academicianswho think they're really
important.
And um, I get into thepharmaceutical world, and uh my
head of clinical research anddevelopment at Wyatt sat me down
(10:41):
and said, Look, I just want tolet you know, and this is what
I've seen before in the past, hesaid, you know, when academics
come into pharmaceutical land,they think they're really
important.
But at the end of the day, noone really cares.
All they care about is thatyou're focused on doing great
drug development and helpingthem be successful.
And that was really a soberingmoment for me.
(11:01):
You know, it was kind ofhumbling in some sense because I
didn't really understand howdrug development has to work,
which is in a team setting.
You know, one of the thingsthat I like to say in my company
is that no one in my companyhas a monopoly on intelligence.
And you need to bring ideasfrom everybody in order to have
successful drug developmentbecause people come from
different places, they havedifferent different levels of
(11:22):
experience.
Michael Koren, MD (11:23):
Right.
Evan Loh, MH (11:24):
And, you know, when I and another theme that I
had that I learned that I stillthink about today is that the
head of our commercial businessalso said, you know, you you
guys here can really spend a lotof time thinking about
transformational changes, makingthe company more efficient,
thinking about doing it withless heads, blah, blah, blah,
blah, blah.
But you know what?
There are no great, there areno great pharmaceutical
(11:47):
companies on this planet.
There are only companies thathave great products.
Focus on the great products.
And that was really a themethat I continue to believe in
today that's really, reallyimportant.
And what are those greatproducts, Michael?
You know, I know that you'reyou're in this field, you've
been in your in this field fordecades, leading uh clinical
(12:07):
trial development, clinicaltrial protocol development,
living in the regulatory world.
At the end of the day, it'sit's a mix, right?
One is that it has to make adifference in a patient's life
in a way that's reallyobjective, demonstrable,
measurable, that a regulator cansee, say yes to.
But at the end of the day, it'sgot to be something that a
doctor is going to care about.
And then finally, I think theother piece that I think
(12:30):
pharmaceutical companies cansometimes lose their way, and it
speaks to the value of I thinkbeing a physician in this
particular field, is just alwaysrespecting and honoring a prima
facie commitment to patientsafety.
Always because you're askingthem to take a potential drug or
an antibody or a vaccine thatcould ultimately hurt them.
(12:52):
And you and I know that thelast thing that we want to ever
have at the patient's bedside isthat we do something or make a
recommendation that the outcomeis less than less than perfect.
And I know nature, nature andmedicine are humbling every day.
We do our best based upon theinformation we have, but we
don't want to activelyparticipate with a company or a
(13:13):
product that ultimately has ahigher risk of actually hurting
someone than making them better.
Michael Koren, MD (13:19):
Yeah, you you said so many incredible things
in in that little discussion anda lot of stuff to unpack.
So I'm gonna uh in noparticular order.
Uh one of the things that yousaid that resonated with me was
this trade-off between theclinical care and the RVU
environment where you're beingvalued based on what you do for
(13:43):
one patient at a time, which isimportant, versus research,
which impacts thousands ofpeople at a time.
And it reminds me of adiscussion I had with my
cardiology fellowship mentor,Dick Devereux.
I don't know if you ever workedwith Dick, but he was he was my
mentor at Cornell duringcardiology fellowship.
And he he kind of drove thatidea into my head in a big way.
(14:06):
He said, You're you know,clinical care is important, but
let's face it, you're affectingone person at a time.
Whereas in the research world,you're literally affecting
thousands or millions of peoplebased on the work you're doing.
And that that always reallyresonated with me.
And I think you had that thatDNA as well.
Uh and and and interestingly,you kind of made the path to
(14:27):
industry in part to pursue thatDNA, if you will.
Evan Loh, MH (14:31):
Yeah, I think that's right.
I think you you hit it right onthe head.
People have asked me, you know,you had such a great career uh
in academia and in cardiology,why'd you leave?
I said, well, in some regards,it was it was unbelievable in
terms of my experience, justlike yours, when you were
actively and you may still beseeing patients, I think one day
a week, uh, to make thatdifference one patient at a
(14:54):
time.
I think though, where the wherethe rubber met the road for me
is that I was getting pulled soheavily into the clinical arena
that I couldn't actually havethe time to think about
fundamental research questionsthat would advance the field and
make patients' lives better.
And I hoped when I moved intothe pharma world that number
(15:15):
one, the science was good, andnumber two, that they that they
were asking good fundamentalquestions that could advance the
care of patients.
And I think that's part of theI think that's part of the
subtlety, Michael, that folksdon't really appreciate that the
science in the pharmaceuticalresearch world and the biotech
world is top shelf.
Michael Koren, MD (15:33):
Yeah, oh no doubt.
Evan Loh, MH (15:34):
Uh it's really top shelf with top shelf
scientists, top shelfresearchers.
I mean, you can't really gointo clinical trials and give
patients these medicines unlessyou've really understood the
products.
And and I've learned so muchthat I'd never learned in
medical school, which ispharmacokinetics,
pharmacodynamics, drugmetabolism, conversions.
(15:56):
I had to go back to my Krebscycles, I had to go back to my,
you know, all yeah, all of it'srelevant.
Michael Koren, MD (16:02):
No, no doubt.
And absolutely.
And and and uh And it's fun touse that stuff. Yeah, it it's
fun to say, oh, I I did studythis when I was a first-year
medical student, and now I seethe relevance after all these
years.
Yeah.
So that is fun.
So I want to also focus onsomething else you said that I
think is really compelling,which is the role of the
(16:24):
physician in drug developmentand how there's a centricity
around the patient and safetywhen we do what we do, that's
probably fundamentally differentthan non-physician researchers.
So maybe you can comment alittle bit more on that.
Evan Loh, MH (16:41):
Yeah, you know, if you think about, you know, if
you think about the predominantpercentage of people that are in
pharmaceutical drugdevelopment, I would say 98% of
them are actuallynon-physicians.
And if you look at theleadership of these
organizations, because they haveto survive, right?
And they have to be, you know,profitable, most of the senior
(17:03):
leaders are actually commercialcommercially driven or from the
finance world.
And so they've never been atthe bedside.
And I do think that there'salso some bias that clinicians
in the pharmaceutical drugworld, drug development world,
are really only good for safetyto evaluate patient safety,
which is great.
They understand that there's noone else can that can actually
(17:25):
do that because then they've notbeen at the bedside.
But I think where that thatassumption goes awry, Michael,
you know, and you and I weretalking about this earlier, is
that I don't think that anyoneelse has really been at the
bedside to understand how aclinician thinks, how they might
use a new medicine, what theirdeterminants of what a good
outcome would be for a patientwith disease X or Y.
(17:49):
And I think that's where Ithink physicians that have the
ability to navigate through thecomplexities of the science, the
translation, the clinicaldevelopment data, as well as on
the commercial side andmarketing side, to be able to
blend those together, I thinkphysicians have an incredibly
important role because we're theonly ones that have ever been
at the bedside.
(18:10):
And I think that one of the oneof the pieces of feedback that
I re that I get veryconsistently, that I'm very
pleased about in my currentcompany, by being a physician
who's the CEO.
I talk about patients everytime I talk publicly with my
company.
Patients are always front andcenter.
Patient safety always is numberone, Michael.
(18:31):
I know you believe in that interms of everything that we do,
but the products that weultimately have.
I asked all of my employees atthe end of the day, if it's your
mother, father, brother,sister, grandmother,
grandfather, would this actuallybe a product that you would
feel comfortable giving to yourmother, father, brother, sister,
grandmother, grandfather?
Michael Koren, MD (18:51):
I love that.
Evan Loh, MH (18:51):
So it is about patient safety.
And so by doing that, you know,everyone in the company comes
up to me and they say, Wow, it'sso great to have a physician
leading this company because Iunderstand who we are fighting
for.
We are fighting for ourpatients.
And that's really the themethat I like to carry through in
my current leadership role.
And I don't think it's anydifferent, Michael, than why I
went to medical school, which iskind of odd because you know,
(19:15):
I'm not actually at the bedside,but I patients are front and
center because they have to be.
Otherwise, otherwise, themission is actually off point.
Michael Koren, MD (19:26):
Yeah, well said.
So that that gets me to sort ofuh the last point I wanted to
drill down with you on, which isthis concept of what is
evidence-based medicine andparticularly how patients could
fit into that.
And as you know, we've had thisdiscussion previously, but kind
(19:46):
of my career path has beenaround not only looking at the
outcomes of the studies that wedo, but also thinking about what
that experience was for allthese patients, and why that's
such a fulfilling experience anda valuable experience for
patients.
And of course, I've I've builtan organization around that to
give patients the opportunity tohave those experiences.
(20:08):
But I think there's a lot ofmisconceptions about what
evidence-based medicine is,first of all, and then secondly,
why it's so attractive for forpatients, for people to get
involved in this process.
So maybe share some of yourthoughts on that.
Evan Loh, MH (20:22):
Yeah, look, I think that they're, you know,
there, if you look at thehistory of clinical research,
right, you can go back to theTuskegee experiments and other
things that you know have givenit a bad name.
And I think that things havereally come a long way.
You know, if you look at theDeclaration of Helsinki and uh
the International Committee onHarmonization of Clinical Trial
(20:46):
Development or ICH, they arefundamental oversight bodies
that we ascribe to, we committo, and that we live by to
ensure that patients, whenthey're asked to participate,
there's no coercion, thatthey're actually in a place
where the experience is actuallyshould be in some ways no
different than getting routineclinical care.
(21:06):
And that in fact we try tominimize the amount of abuse of
in terms of uh blood draws orother procedures or other you
know x-rays or other things.
Michael Koren, MD (21:18):
Data collection.
We won't we won't call itabuse, we'll call it data
collection.
Evan Loh, MH (21:21):
Yeah, I think abuse is not the right word for
it, but um, thank you for that.
But I think it's really theamount of data collection.
Right.
And I think that there's also amoral contract that you develop
with these patients or evenknown volunteers who participate
in pharmacokinetic studies toask them to actually
participate, is that I thinkthat they're what what what I
(21:44):
think you've experienced as wellas I've experienced is that
there is a deep-seated level ofaltruism that humans actually
have.
Yeah, that they say, you knowwhat, it may not be good for me,
but if this is data that yousay could lead to this
improvement or this new medicinehelping this cohort of
individuals down the road, I'mall in.
Yeah, I'm all in to help you.
(22:05):
Yeah.
And and I just continue to justtip my hat to to all of those
patients who say yes.
And when they say yes, I alsosay to my folks that are working
on my side, remember whatthey've said yes to.
And we have an absoluteobligation to transparency, to
(22:27):
treat them well, to let them beable to say that I'm done.
I don't want to participateanymore, to give them complete
freedom to, you know, determinetheir pathway, and at the end of
the day, interact with theirphysicians in a way that at the
right time they can also sharethe outcomes of the trial with
them so that they know what theyparticipated in.
So I think that there's athere's a full circle here,
(22:48):
Michael, as you said, in termsof their participation to
generate these data.
Michael Koren, MD (22:52):
Yeah-
But in the absence of thesedata, we don't get life-saving
cancer drugs, we don't getlife-saving cardiovascular
drugs, we don't get life-savingdrugs that, you know, change the
natural history of people withrheumatoid arthritis.
You remember the days when wewere at the Brigham where these
elderly patients would come inin wheelchairs with deformed
joints, their hands, their legs,they couldn't walk.
(23:14):
You know, today medicalstudents don't see that type of
rheumatoid arthritis.
Yeah, so interesting.
Evan Loh, MH (23:19):
Right?
And it's because of theproteins that we've developed,
the Enbrels and the Humiras andthings like that, the disease
has completely changed.
I mean, uh and I just am soexcited to be part of this uh
industry.
I mean, think about the naturalhistory of cystic fibrosis,
right?
Uh they used to all uh perish,you know, in their late teens.
Today, uh the natural historyof patients with cystic
(23:42):
fibrosis, because of theinterventions and the places
that uh these these new drugshave gone.
64 years, Michael.
Is the life expectancy of apatient with cystic fibrosis.
Michael Koren, MD (23:52):
Amazing.
Evan Loh, MH (23:53):
Five more decades of life.
I mean, that's amazing, right?
Michael Koren, MD (23:57):
It's it's it's absolutely fabulous.
It's absolutely fabulous.
And so you know, uh, we used toum compare notes all the time
at at the different cardiologymeetings when you were uh uh
running the heart failureprogram at Penn.
I remember we we had somediscussions, and obviously you
were doing you were gettingpeople in clinical trials that
were really, really sick.
And um, you know, in though inthat case, a lot of the people
are really doing it to see ifthey can improve their survival.
(24:20):
But there's so many otherelements of participation that
people love.
Uh and my favorite statistic toquote is when you ask an
average American or averageEuropean who's never been
exposed to clinical researchwhether or not they're
interested in being involved ina clinical trial, only 40% say
yes.
But if you ask somebody that'scompleted a research study, if
(24:43):
you would do a second study, 97to 99% of people say yes.
And the reason that there'sthat high conversion rate to
being true believers and fans inthe process is because they get
so many things.
They get the socialization, theintense interaction with the
staff and the physicians, whichas you alluded to, is not really
(25:03):
part of clinical medicinenowadays.
Everything has become sort ofcookbook and and just
processing.
And the the human touch hasbeen unfortunately extracted a
lot from from clinical medicine,but you still get that in
research, ironically, when youthink about it.
And uh, of course, there's alot of information that's shared
with the patients.
Uh people get imaging teststhat they might not get, people
(25:25):
get uh treatments that they mayor may not get, although we are
always very clear that sometimeswe don't know what you're on,
and sometimes it can be aplacebo.
But and and there's alsostipends.
People in many cases get paidfor their time in travel.
That is helpful for a lot ofpeople.
It could be the difference uhbetween uh not a great Christmas
and having more money for giftsfor for the family.
So you know these are practicalthings that really impacted a
(25:47):
lot of our patients.
But you brought up the thingthat I think is the most
compelling, which is at the endof the day, we get these results
that change the world.
And people love that.
Uh and and it it could changethe world for that generic
person out there, or it canchange the world for a family
member because it's a geneticdisease that we're learning
(26:08):
about.
And and so to me, this is whatfloats my boat.
This is what gets me excited.
And um, you know, this is theexperiential part of
evidence-based medicine.
And then there's one other partthat I don't think people
understand that well, and I'dlove to hear your comments on
that, which is, and we kind ofalluded to it in some of our
stories, but you know, 50 yearsago, the way physicians worked
(26:32):
was kind of, okay, well, myfriend, the oncologist, tried
this and maybe we'll try it, uh,versus what we do now, which is
when we actually use a medicinethat's been approved, we know a
lot about it.
And we talked about digoxin,which is probably the oldest
cardiac drug.
Uh uh aspirin may have been theoldest cardiac drug we didn't
even know it was a cardiac drugfor many years.
Evan Loh, MH (26:53):
No, that's right.
But digoxin has been somethingthat's been uh used by
physicians for over 200 years,and it was only in the last 20
years or so where we actuallyhad a study to show that it kind
of worked, but maybe not asmuch as we thought.
So this whole concept of justassuming that the physician has
all this information versusactually having the information
(27:17):
is a fundamental transformativemedicine uh transformative part
of evidence-based medicine.
But your your reaction to that.
I I think it's spot on.
It's it it is, I think when youlook at evidence-based
medicine, Michael, I think youcan you can take it to one
extreme, which is that if youdon't have the evidence, you
can't use it.
However, I think that there isa gradient of of data that
(27:44):
actually you can couple togetherwith your bedside experiences
to ultimately have you decidewhat's what's best at the end of
the day.
I think that you know, wherethings have gone a little
sideways recently is uh notreally understanding or
appreciating how hard it is togenerate those studies.
(28:06):
And when you look at theanalytics that go along with it,
how important they are to, Ithink being able to answer a
fundamental clinical question.
And number two, I think howdoes it ultimately get applied
in the clinical care?
Because as you know, sometimesthese clinical trials are
designed in ways where you haveto try to get as pure a
(28:27):
population as possible to beable to have that intervention
be the one thing that you couldactually determine was making
the difference, as opposed toputting it in the context of a
clinical care algorithm whereyou actually may have other
drugs in the mix at the time.
But the regulators and alsoclinicians want to see the
effect of that one drug asopposed to that in combination.
(28:51):
Those those data come later,uh, but it's one of those things
where I think it really is veryhelpful.
And I think when you go back toour training and you think
about some of the some of thetrials that we looked at, right?
Such as the natural history ofuntreated aortic stenosis, you
know, from Eugene Braunwald, oryou know, the uh outcome of
(29:14):
low-gradient aortic stenosis andLB dysfunction, right?
That Blase Carabello study wasdone in like 20 patients.
I mean, that's what we basedour practice on, was just what
was published, right?
I mean, it was the best we hadat that time.
But now you're you're talkingabout trials that have tens of
thousands of patients of data,like you said.
(29:35):
We really do know that thesedrugs, number one, are
fundamentally safe, or theyhave, you know, a risk of
diarrhea or nausea or or whathave you.
But at the end of the day, wecan actually be able to
actually, in a very, veryaccurate way, tell the clinician
exactly what they couldpotentially expect on a
population basis for the effectsize.
Michael Koren, MD (29:56):
Absolutely.
Absolutely.
And you you brought upsomething that's interesting.
Is again, it's the balancebetween some of the clinical
aspects and the scientificaspects.
And all the things that we doin evidence-based medicine is
built on these protocols, but itdoesn't take away our
commitment to the patients anddoing the right thing for the
patient.
I'll give you a recent exampleof that.
So, as you know, I've done alot of work in the lipid world,
(30:19):
and we've done a lot of uh earlyphase clinical trials here in
Jacksonville, and we had apatient last year who was in for
a very early phase lipid study,which involved confinement for
seven days here in our offices.
And um, very nice guy.
Um, probably not somebody thatwas interacting with the
standard medical profession asmuch as he should, had multiple
(30:41):
cardiovascular risk factors, butactually no known actual heart
disease.
And he's in a lipid study, andhe, you know, starts to get a
little angina when he's herewith us.
Okay.
And um, because of the factthat we're, you know, even
though we have a protocol thatdoesn't really evaluate angina,
of course, for the safety of thepatient, we do what's
(31:02):
necessary.
And then we find he has alittle troponin bump, which
means that he had some damage tohis heart muscle.
And uh so uh literally we gothim from our confinement area to
the cath lab, which is ofcourse not part of the protocol
at all, but this is what we needto do for the patient.
And he had a very seriousobstruction of his coronary
(31:23):
artery that we fixed.
And um uh and so he comes backuh after that, and you know, I
didn't know how he was gonnareact to the whole thing.
You know, would he blame thestudy for this whole thing?
And Evan, he was so thankful.
He literally thanked me forsaving his life because you know
he said, you know, I Iunderstand that if it wasn't for
(31:43):
this study, I would not havehad that experience.
And even though I did end uphaving a small heart attack, it
turns out you would have neverknown this problem and you
literally saved my life.
And so it's an example of inthe uh in the process of
creating evidence-based medicinefor a new lipid drug, we
actually had a huge impact onsomebody's life.
(32:03):
And and and again, this is tome why it's so important what we
do.
And and and you've touched thisspace in so many places during
your career from being a medicalstudent and drawing blood on
people to uh to running a heartfailure clinic and now actually
running a drug company thatfinds the funds and finds the
logistics to actually run thesestudies across the world.
(32:25):
So again, congratulations andthanks for everything that you
do.
Evan Loh, MH (32:30):
Look, Michael, thanks, thanks for that.
I I love that story.
And you know, at the end of theday, and I know you care deeply
about eviden evidence-basedmedicines, but you know, what I
like to say, you know, is thatat the end of the day, data's
forgotten, but stories areremembered.
And what are we in the businessof?
We're in the business ofgenerating great patient
stories.
And that through line has notchanged a whit from our time in
(32:53):
medical school to today.
And I'm just honored andprivileged to have been part of
this industry and making adifference in patients' lives
each and every day.
Michael Koren, MD (33:04):
Well, that was a brilliant way to end our
discussion, and I want to thankyou for being part of
MedEvidence! and thank you forspending some time with us.
And um, this has been a truepleasure for me.
Thank you, Evan.
Evan Loh, MH (33:15):
Tons of fun, Michael.
Thank you so much.
Announcement (33:17):
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