June 27, 2025 • 45 mins
Surveys show that 97-99% of participants who participate in one clinical research study would sign up for another. We wind out why in this episode, recorded in front of a live audience. Dr. Michael Koren and Nalini Jones, CCRC are joined by three clinical research patients to review the good, the bad, and the ugly in the history of clinical research. They also discuss the ins and outs of how the clinical research process works and share patient stories of their experiences as research participants. Step into a behind-the-scenes look at how we get from medical ideas to medical treatments and how the process leaves a lasting impact on patients and the legacy of knowledge.
Be a part of advancing science by participating in clinical research.
Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.com
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Announcement (00:00):
Welcome to the MedEvidence podcast.
This episode is a rebroadcastfrom a live MedEvidence!
presentation.
Dr. Michael Koren (00:06):
Thank you very much.
I appreciate that, so we'regoing to do something different
today.
Who in the audience has been toone of our sessions before here
in this room?
Okay, most people.
Who has not?
Who's never been here?
Okay, that's good About.
Maybe 40% has not.
(00:26):
So, for those of you who havenot been here, what we usually
do is we present a particulararea of medicine it's often me
or somebody else with anotherexpert and we go through that.
So it could be an expert onintestinal diseases, or expert
neurologist, or an expert incongestive heart failure, and
(00:49):
then that person and myself willhave a conversation, with
audience input of course.
But we decided today to dosomething different.
Instead of talking about anarea of medicine, what we're
going to do today is just talkabout the overall research
process, Because in our othertalks we always allude to
(01:11):
research.
In fact, sometimes we go intodetails about research, and the
concept here is this MedEvidence concept that we want
everybody to understandinformation and we want you to
understand it from thisstandpoint.
In medicine most things in life,but particularly in medicine
there are things that we knowfor sure, there's things that we
(01:33):
definitely do not know, andthen there's a process to learn
about the things that we don'tknow.
So, in a simple case, whensomebody comes in to me as a
cardiologist and is having afunny pain this, that and the
other place I get an EKG and Ican tell you if you're having a
heart attack immediately, sothat I know; but I don't know
(01:55):
exactly what's causing yourchest pain, and then we figure
it out.
More broadly, everything inmedicine falls into that
category.
When you come in, whatever yourproblem is, there's stuff that
we know about it, there's stuffthat we don't know about it, and
there's a process to learn, andone of the most powerful
(02:18):
processes that we have to learnis clinical research, and the
three heroes here on stage haveall been part of that process
and they're going to share theirstories with you.
So I'm actually really excitedabout the interaction.
And then the person that makesthe heroes heroes is actually
sitting right next to me, NaliniJones, who is truly, I'm truly
blessed to have her as ourdirector at our large site on
(02:41):
University Boulevard inJacksonville.
Nalini is brilliant, she'scaring and she's an incredibly
good administrator, so she'sactually the manager that runs
the show day to day, and soshe's going to be here up with
me on the stage interacting withour guests and also to answer
questions from the standpoint,not of the physician,
(03:01):
necessarily, but of the personthat's kind of running the
day-to-day operations.
So that's who everybody is.
And why don't we just do this,Nalini just give us 30 seconds
on your background and soeverybody can hear your voice.
Nalini Jones, BBA, CCRC (03:14):
Sure .
Again.
My name is Nalini Jones and Iam the site director at the
Jacksonville Center for ClinicalResearch, the University
Boulevard location.
I've been with ENCORE Researchfor 26 years now, started as a
research assistant.
Dr. Michael Koren (03:27):
She started in utero, by the way, 26 years
Nalini Jones, BBA, CCRC (03:30):
I was born in the parking lot.
I've been there for a long time,worked my way up to a study
coordinator and then to a sitemanager, and it's been a very
rewarding experience for mepersonally, just because of the
blessings that we receive fromthe participants that come in to
work with us.
We can go more in-depth later,but you guys have always been a
(03:54):
huge part of the success of ourorganization.
Dr. Michael Koren (03:57):
So, Louise, introduce yourself, so everybody
can hear your voice.
Dorothy "Louise" Rohan (04:00):
Hi, I'm Dorothy Louise Rohan and I have
been in clinical research for anumber of years.
I've been with well, I think,as it was already stated, since
2008 with yes, and that is awonderful staff.
I cannot say enough about theemployees there.
(04:21):
They care for you as though youwere their family and I'm just
really proud and I feel gratefulto be a part of that,
Dr. Michael Koren (04:29):
Thank you, and we'll get into the
testimonials in a second,but tell everybody where you
grew up.
Dorothy "Louise" Rohan (04:35):
Oh, I grew up in a small town in
middle Tennessee and I'm a greatgrandmother and I'm married to
the most wonderful man that Godever created.
Dr. Michael Koren (04:47):
Wow Aw, I want to meet that guy.
David, you're up.
Dave Gnage (04:54):
My name's Dave Gnage .
I grew up in western New York,very close to Niagara Falls.
Dr. Michael Koren (05:01):
Are you still a Buffalo Bills fan?
Dave Gnage (05:03):
Absolutely a Buffalo Bills fan.
My uncle took me to the veryfirst Buffalo Bills game.
Dr. Michael Koren (05:09):
Wow
Dave Gnage (05:10):
Well, when they started in 1960.
I'm probably the oldest guy onthis platform today.
I'm married, we have a numberof kids and we have a
granddaughter who lives with usthat we're raising, and she
happens to be here today.
I've been in a number of studiesI started with.
(05:34):
Well, first of all, I wasreferred for some studies for
heart issues, but I didn't passthe test, which is good because
I was better than what theywanted.
But then the COVID test camealong, so I signed up for that
and my wife said well, I can dothat too.
(05:57):
So I was taking Pfizer and shesigned up for Moderna, I think.
And my granddaughter said well,if you're doing it, I want to
do it.
So if I could just go back alittle bit, when she came with
us, I thought she should learnthat people give blood for blood
(06:20):
tests.
So when she was about 10, Itook her to when I was having a
blood test I said come just seewhat goes on.
Well, when the needle came out,she ran out of the room.
But then, when she gotinterested in the test, I
explained that she's going tohave blood tests, have blood
(06:41):
tests, okay.
And she signed up and wasaccepted.
We went in for her first bloodtest and they numbed her arm a
little bit and I held her handand she was a trooper.
Well, she's been through threedifferent research projects and
(07:04):
by the time we got to the lastone, when it was time for a
blood test, she marches into theroom, puts her arm down.
They ask well, she didn't puther arm down.
They ask what arm do you wantto use?
And she pointed to me and saidhis,
Dr. Michael Koren (07:19):
That's a good line.
Thank you for that.
So the biggest question for youis your wife, half as good as
Louise's husband.
Dave Gnage (07:31):
Louise, she's better .
Dorothy "Louise" Rohan (07:33):
Oh.
We must keep them apart.
Dr. Michael Koren (07:38):
And how about you, Tony?
Are you married?
Anthony Langhals (07:40):
Yes, I am.
As a matter of fact, my name isTony Langels and my beautiful
wife.
She's sitting at the tablethere with the patriotic jacket
on.
Nice, all right so sheaccompanied me here tonight
today, but anyhow, I'm from Lima, Ohio and spent time with the
military, you know, 20 years.
But anyhow, I got to say youknow I had a long presentation
(08:03):
but, Dave, he took a lot of mytime here, you know.
Dr. Michael Koren (08:05):
So I kind of have to shorten mine, you know,
so that we get out of here.
We have plenty of time, but goahead, just tell us a little bit
about your background.
Okay, well, like.
Anthony Langhals (08:13):
I say I was in the military aviation with the
Navy and also I worked with AT&TBell South and Vistacon making
contact lenses.
So you know, know a little bitabout that.
But anyhow, you know, I went toUNF, graduated there, but I've
(08:34):
got to say I'm shocked at thelayout here.
I've never been here before inthe studio here, you know.
So you know I'm very impressedwith the layout and all the
attendance here.
So, and also I live on thesouth side, uh, real close to
the uh research center there, uh, Kennerly and University.
I could almost walk to it.
(08:55):
So, uh, it makes it convenientfor me to even get there.
So anyhow, uh, you know, I wantto thank Dr Koren for inviting
me to be up here and looking tohave a good time up here.
Dr. Michael Koren (09:08):
Well, thank you very much.
That's terrific.
So thank you for being on stage, and I'm glad that you all have
great spouses.
My story with regard to that ismy wife and I were happy for 25
years and then we met eachother.
All right, so people who havebeen here before know that
(09:31):
there's no such thing as a freelunch, and we like to get the
audience involved in thequestion and answers.
So we're going to start by thisfirst question.
By volunteering in a clinicaltrial, participants play a vital
role in A.
training robots to becomedoctors.
B keeping the coffee machinesrunning at clinical research
(09:54):
sites.
C.
contributing to scientificprogress that could benefit
countless others in the future.
D.
a plausible escape from anagging spouse.
You guys obviously don't haveto worry about that one.
Or E.
proving that laughter ismedicine but hard to get
(10:14):
approved by the FDA.
All right, you guys are good,absolutely.
C is the correct answer.
All right, you're so good.
We'll give you one.
More.
Benefits that patients canreasonably expect while
participating in a clinicaltrial include, A.
a lifetime supply of hospitalgowns.
B.
(10:36):
a cure for daytime insomnia.
C.
free Medications based onessential oils and moonlight.
D.
inside knowledge, stipends fortime and travel and a medical
legacy Sounds kind of AMedEvidence t-shirt.
(10:57):
If you behave yourself Well, Ithink we all know that D.
is the correct answer.
You can get a MedEvidencet-shirt, but you don't really
have to behave yourself.
All right.
So with that introduction, Ijust want to maybe spend 15
minutes giving everybody alittle bit of background about
how clinical research works, andthen we'll get back to the
(11:17):
discussion.
So there are basically two waysthat physicians make decisions.
One is called anecdotal and theother one is called
evidence-based.
And 50 years ago, virtually allmedical decisions were based on
anecdotes.
So a physician would be in asituation and they would
(11:38):
recognize the situation and theywould say, okay, well, in my
experience, this is what works.
Or, oh, I tried this for thelast five times and it seemed to
work, so let's try it again.
Or, oh my God, I tried this andit was horrible, so I'm not
going to try it again in you,even though some people think it
works.
So it was all based on anecdotes, but we've moved away from that
(12:00):
model as much as possible.
It still happens, but now wewant to do everything based on
evidence.
And when we say based onevidence, that means these are
things that are proven to workin a structured experiment or a
structured clinical trial.
And under those circumstanceswe say, okay, a thousand people
tried treatment A, a thousandpeople tried treatment B and
(12:24):
treatment A worked better thantreatment B.
So, doctors around the world,let's use treatment A and that's
the concept behindevidence-based medicine.
And we apply this to new drugdevelopment, to new procedures,
to new psychiatric methods.
This is ways that we do thingsand there's a whole process to
(12:45):
run clinical trials or researchin order to get evidence, so
physicians and otherpractitioners around the world
can make good decisions based onreal information rather than
just what they saw over the lastyear.
So this is a huge breakthroughin medicine and this concept is
ancient in some ways, but,believe it or not, it's only
(13:07):
been structured in its currentform since the 1970s and early
80s.
So prior to around 1980, it wasvery, very difficult to do a
really well-conducted structuredclinical trial.
But since 1980, which is lessthan 50 years ago, we now have
this incredible mechanism andtrained professionals like
(13:29):
Nalini Jones who know how to runthese studies, and this has
become a phenomenon throughoutthe US and other parts of the
world where we have people thatspend their entire career just
running clinical trials.
Now some doctors get trained inthat during medical school, but
most really don't.
And a subspecialty in medicineare people like me.
(13:52):
I practice cardiology.
I'm a fully trainedcardiologist and internist, but
I spent extra time learning howto run clinical trials.
So it's a subspecialty in andof itself, where the skill set
to run clinical trials issomething you apply to your
practice and help others do, aswe do have done here in
Jacksonville.
(14:12):
Now, evidence-based medicine inits current form evolved from a
lot of learning experiences, andwe like to call those learning
experiences the good, the badand the ugly, and sometimes
research gets a bad name.
People say, oh, you're a guineapig or you're just
experimenting on me, and thatbad name has sometimes come from
(14:33):
things that happened way in thepast, but again over the past
50 years.
This is now a highly ethical,highly structured, high quality
way of not only discovering thetruth for society, but always to
try to get the best outcomesfor our patients.
So throughout the process, oneof the ethical principles is
that we're always advocating forour patients, even if we're not
(14:56):
sure what arm of a study thatthey're in, and we're going to
go over some of those details.
So let's talk about the good.
So the concept of comparing twogroups is really an ancient one.
In fact it goes back to theBible, and there's a story from
the book of Daniel which talksabout when Daniel was
(15:17):
interfacing with the Babylonians.
He noticed that the Babylonianshad this really rich diet and
he mentioned that.
Well, let's compare whathappens if you eat the
Babylonian diet versus thehealthy diet.
And lo and behold, Daniel andhis disciples ate the healthy
diet and they stated, that after10 years, they felt great that
(15:40):
there was a big differencecompared to the Babylonian diet.
So this is the basic concept ofwhat's called randomization, or
comparing two groups, where onegroup does one thing and the
other group does another.
Obviously, current trials aremuch more sophisticated, but
this is an example of doingsomething in a structured way.
So it's an early example ofwhat we call the good.
(16:01):
Another example of the good isa really interesting project
which is considered the firstquote modern age clinical trial.
It's not really modern becauseit goes back to 1721.
But in the 16th and 17thcenturies and the 18th century
1721 would be the 18th centurysmallpox was absolutely
(16:25):
devastating.
So when smallpox hit acommunity, up to a third of the
people in the community died.
Imagine that.
So these were devastatingthings and people didn't know
what to do.
They weren't sure how to dealwith it, they didn't have any
good solutions, and it turnedout that they knew of what was
called inoculation, which is aconcept that actually came from
(16:49):
Turkey and Africa, where peoplewho got inoculated with the pus
of somebody who survivedsmallpox would be given that in
an injection, usually in theirleg, and they seemed to be
protected against smallpox whenit hit the community.
So this was considered a crazyidea.
(17:09):
Imagine going to a doctor andgetting a slash in your leg and
then putting pus in your leg.
But that was the concept ofinoculation.
So in 1721, everybody knew thatthere was this smallpox coming
to Great Britain.
One of the people in the royalfamily went to the king and said
(17:30):
we've got to do something.
I'm desperate, let's do thisinoculation.
Back in those days, of course,the concept was that prisoners
didn't have the same rights aseverybody else.
They went to the prisoners andthey took six people and they
said okay, this is what we'regoing to do.
We know that this epidemic iscoming and we're going to give
you this inoculation procedure.
In exchange for thatinoculation procedure, your
(17:52):
sentences will be commuted,you'll be free after that.
So, lo and behold, they gavethese six people inoculations,
and when the smallpox epidemicoccurred, they actually put
these people in the room withactive victims of smallpox and
none of them got sick.
And so this was the first timewhere people thought ahead,
(18:15):
identified a group of patients,prepared them with a medical
intervention and then showedthat it worked.
During the same epidemic, therewas a guy named Cotton Mather
who was one of the Puritans inMassachusetts, and a guy named
Onesimus who was an Africanslave, and they collaborated in
(18:38):
1721 on the exact same, duringthe exact same epidemic.
First it hit the UK, Britainand then it came to the United
States, of course, through theships, and they actually put in
over 200 patients from theMassachusetts colony and
inoculated them, and the peoplethat were inoculated had a death
rate of only 2% during thesmallpox epidemic, whereas if
(19:00):
you were not inoculated, yourlikelihood of dying was 16%.
So, again, this led to thislarger structured experiment in
the United States, which isinteresting a collaboration
between a Puritan minister andan African slave that helped the
people of Boston at that time.
So really, really cool stuff.
So we call this the good.
And again, these are not evenclose to the kind of structured
(19:23):
studies that we do these days.
But along the way, there's oneother thing All the inoculated
prisoners remain free ofsmallpox.
A couple little things.
Three of the prisoners end upback in jail for future crimes.
So that problem existed, butway back then, and one of the
patients actually lied.
(19:47):
So one of the patients in thisstudy actually never disclosed
the fact that she had smallpoxbefore, and because she had
smallpox before, it was very,very difficult for her to
actually get the proper reactionfrom the inoculation, which was
a sign that she was alreadyimmune to smallpox.
So that's why we go throughthis whole business about making
sure that we're getting theright patients into studies.
(20:09):
So let's talk about some of thenot-so-good stuff.
So who's here heard of thethalidomide babies?
Oh yeah, hopefully everybody.
Okay, so this was a drug thatwas highly marketed in Europe
that led to birth defects andthe typical thalidom.
My baby is an unfortunate childthat is born with no upper
(20:30):
extremities.
They're cut off toward theshoulder.
Ironically, a Germanpharmaceutical company was
marketing this for morningsickness for pregnant women, and
so this was a widely availabledrug in Europe in the 1950s and
early 1960s.
The German company tried to getthis done in the United States
and they hired 50 doctors to runa clinical trial of about 875
(20:55):
patients in the 1950s, and theprincipal investigators did this
study and they noticed that thedrug really didn't work very
well for what they wereadvocating it for.
So they were talking about itbeing for nausea, and it didn't
really help.
They were talking about itbeing something for insomnia it
really didn't help.
So the 50 principalinvestigators, after they
(21:16):
finished the study, didn't useit.
But in those days you didn'tneed to finish the trials before
a drug got approved.
So the German pharmaceuticalcompany sent the drug to 1,270
other doctors in the UnitedStates who used it in a couple
thousand patients.
So the United States wasbasically spared from the worst
of the thalidomide crisis, andthe reason for that was because
(21:40):
of a heroine named FrancisKelsey.
Dr.
Frances Kelsey, who was aphysician who worked for the FDA
, and she looked at the datafrom the clinical trial and the
German company was trying to getfull marketing approval in the
United States and she said no,this is not a good drug, this
should not be in the UnitedStates, and she blocked it.
And so when she blocked it andthe results came out that this
(22:03):
caused birth defects, it led toa very important law in the
United States, which was anamendment of the Food and Drug
Act in 1962.
And at that point that was thefirst really important
legislation that required theclinical trials to be completed
before you actually put the drugout in the marketplace.
So that was really an importantbreakthrough in terms of safety
(22:25):
.
And then an ugly incident issomething I'm sure most of you
have heard about, which is theTuskegee syphilis study, and
this study is really a horribleepisode of unethical behavior in
a study that was funded by theU.
S.
government.
It was actually originallyfunded by the chairman of Sears
(22:46):
Roebuck and he had sympathy forthe plight of poor people in the
rural South and wanted todonate some money for it, and he
wanted to study how syphiliswas affecting that population
before there was any treatmentfor syphilis.
So that started actually in thevery, very early 1930s.
(23:08):
And then the U.
S.
Public Health Service took overthe study when the private
grant ran out and they wanted tounderstand what happened in
syphilis.
So they enrolled about 400black men they were all very
poor sharecroppers withouteducation and then they had 200
or so uninfected controls andthey wanted to see what happened
over the course of their livesand how syphilis developed
(23:29):
complications.
Well, syphilis is untreated, isa horrible disease, ultimately
resulting in severe dementia anda number of other complications
.
The patients that were involvedin this were never told they
were being observed in a study.
They were just told that theyhad bad blood.
There was no consent process.
When the first antibiotics cameout, which was they weren't
(23:50):
very good in 1930s, but peoplewere using arsenic and bismuth
to try to treat infections, butthese unfortunate men were not
told about this.
When penicillin came out, theywere not told about it.
In fact, when this group ofpatients was being looked at for
participation in the military,when all the other recruits were
getting injections ofantibiotics, they were
(24:12):
specifically banned from gettingthose injections because they
didn't want to mess up theresearch.
So this was really, really bad.
And then the government, theCenters for Disease Control
actually looked at the study in1969, while they were still
following these people, and saidokay, let's keep on going.
And it wasn't until 1972, whenan expose came out in the
(24:32):
Washington Post, that peoplesaid what are you doing here?
You're subjecting these peopleto the rages of this disease.
That's very treatable at thispoint, and at that point it led
to the National Research Act in1974, which is really what
started the current modernclinical trial movement.
So after this, everybody thatwas going to be in a study had
(24:56):
to give written consent.
After this, everybody that's ina study had to be under the
watchful eye of an institutionalreview board.
So before we do any research,the researchers have to present
all the study methods to aninstitutional review board to
make sure it's completelyethical.
All this came out of thistragedy.
So there's a couple ofinteresting elements to this,
(25:18):
and one of the elements of it isthat it took so long for people
to respond to something thatshould have been so obvious.
That's horrible, but the otherthing is that it's created a lot
of racial tension.
There's a lot of people in theAfrican-American community that
haven't trusted research becauseof this story.
But it's actually more of acomplicated story than just
about race, because this wasactually conducted at a
(25:41):
historically black university,Tuskegee University, and there
were plenty of doctors andnurses that were part of the
study that were African American.
So it's really more, in myopinion, race is part of it, but
it was also socioeconomic isthat people that didn't have the
knowledge were being exploited,and that's a sad part of this
whole thing and that's one ofthe reasons why we have MedE
(26:03):
vidence and other things.
We want our people that getinvolved in research to be
really knowledgeable.
In fact, we want you to be moreknowledgeable than the average
consumer, because we see thatactually as a benefit of the
research, and this is certainlya learning that happened through
these historical incidences.
So this gets into the conceptof who's looking out for you.
(26:24):
So, as we know, we have theFood and Drug Administration and
that's an administrative bodyof the federal government and
again, as mentioned, FrancisKelsey was a true pioneer who
got the point across to theauthorities that you really need
to look at all the researchdata in a very structured way
before you approve a drug.
(26:45):
And now the process of getting adrug approved is a mammoth
process.
It takes tens of thousands ofpeople to do this tens of
thousands of volunteers andthousands of scientists and
nurses and other people that areall part of this process, and
it's a very expensive processright now, but it assures the
safety and throughout this we'reconstantly sharing information.
(27:07):
So we have a process, forexample, called a serious
adverse event report and theresponsibility of a physician
like me.
If I learn of a strange sideeffect in somebody that's
involved in the study, Iimmediately have to send that
information to the Food and DrugAdministration and it's
immediately disseminatedthroughout the world.
So I come into my office everymorning and I get reports from
(27:28):
all over the world about whatcould possibly go wrong and
whether or not the doctorsinvolved there thought it was
related to the study or not.
It's almost never related tothe study medication, but I get
all this information and if Isee something that's relevant to
my patients, I can share itwith the patients.
So it's a cool part of theprocess.
I mentioned the IRB,Institutional Review Board.
(27:49):
Their sole goal is just to makesure that everything is done
ethically and then, whateverpossible, there will be a
benefit to the patients forparticipating in clinical
research.
And then you have excuse me, youhave your investigators, like
myself, many of whom arecertified.
I'm a certified principalinvestigator.
That's like being boardcertified in cardiology.
(28:10):
I have that certificate forclinical research and we are
knowledgeable people that lookout for our patients and can
share insights that willhopefully not only affect you in
that study but help you withother elements of your life,
other medical issues, and we'lltalk more about that momentarily
.
So when you get involved in aclinical trial, you can get
(28:32):
involved in different stages.
So before any study gets donein human beings, we look at it
in animals, in test tubes, allkinds of analyses.
So nowadays this preclinical,pre-patient information is so
accurate and so valuable that wereally screen out most of the
side effects before a patienteven touches that.
(28:54):
Not 100%, but there's a reallyreally good screening process
before any patients getsubjected to any of these
medications that we use orprocedures.
It doesn't have to be amedication.
But then, once it gets past thepreclinical, then we have these
phases phase one, two and three.
So phase one is called first inhuman phase.
So this is where you'll come inand for the first, maybe 100
(29:19):
patients that ever get a product.
They are monitored 24/7 for aperiod of time it could be a
week or two.
Any curiosity has anybody heredone a phase one study as a
volunteer?
We have one, so we might okay acouple.
That's nice.
(29:39):
So that's the first in humantype of work and we do that in
Jacksonville in our organization.
We also do it in Inverness,Florida, in our organization,
and we have sister sites in SanAntonio, texas, in Orlando, that
also do it.
So this is again first inhumans, where you come in and we
look at you really, reallycarefully.
You're constantly monitored andwe want to make sure that it's
safe in the first hundred or sopatients that get exposed to a
(30:00):
particular product.
Then, after phase one, you goto phase two.
That typically involvesanywhere between 200 and 500
patients and that's when you getthe dose right.
So in phase two you have to seeis the dose 1 milligram or 50
milligrams and we look at anumber of factors to make that
ultimate determination.
And then, once phase two iscompleted and the company
(30:23):
decides that they really want toinvest in the product, which
now is going to be a hugeinvestment, they go to phase
three and that's when you takethe dose that you're going to
actually use and try to getregulatory approval.
And that typically involvesthousands, if not tens of
thousands, of patients.
So just to give you a littleinsight, I do a lot of work with
cholesterol drugs and the firstcholesterol drug that was
(30:47):
approved in the United Stateswas called Lovastan and that was
approved in a study of about800 patients.
That was before I was active.
That got approved actually as Iwas in medical school.
Then I was active in thebeginning in the mid-1990s, and
(31:08):
the big drug that got developedthen was atorvastan or Lipitor,
and I was very involved withthat and actually that's a drug
that was developed inJacksonville to a large degree.
13% of all patients who wereexposed to atorvastan before it
was approved by the FDA camefrom Northeast Florida, in part
because of the work that me andmy colleagues did here and that
(31:28):
involved 3,000 patients.
So we went from 800 for thefirst drug to 3,000.
Lipitor is the fifth drugactually in the class and then
Crestor or rosuvastatin had12,000 patients to get approval.
So more and more patients,despite the fact that we even
have more and more experience inthe class and now the studies
that we're doing for these newcholesterol drugs involve 20,000
(31:51):
patients.
So there's a lot of informationthat we get before these drugs
are approved, but with thatthere's a lot of opportunity for
being involved and the benefitsfrom all that.
Phase four is the term that weuse once a drug has been
approved by the FDA, and this iswhat we call post-marketing
studies.
And there's even a phase fiveright now, which gets into all
(32:14):
the pharmaco-economics.
So when you have a situationwhere you're dealing with
expensive drugs, who gets them?
Some of these new drugs areusing these incredible
technologies, nobel Prizewinning technologies.
They're very sophisticated,they're very expensive to
manufacture and not everybodycan afford them.
So how do we decide who getswhat?
And that's considered a phasefive study.
(32:36):
So who are the players?
Well, I'm a principalinvestigator and my job is to
lead the team and to be a voiceof reason, hopefully, but also
somebody that has the medicalknowledge to answer questions
when they come up, especiallyquestions around, "could this be
a side effect?
Or, oh, my other doctor put meon this drug.
(32:57):
Is it still safe for me to bein the trial?
These are the questions that weget all the time.
Then you have clinical researchcoordinators like Nalini and
her team, who really are doingthe bulk of the work.
Quite frankly, so, they're thepeople that literally are
meeting the patients, schedulingthe patients and then
collecting all the informationand they work with teams.
They have helpers that do dataentry and other things, but
(33:19):
they're the core day-to-daypeople that are doing the work
and of course, I'm around ifthey need my help, which is
actually relatively infrequentbecause they're so good, but
when they're new they would needour help more.
But these are the people thatare doing the day-to-day stuff.
And then, most importantly, thevolunteers and we're going to
be talking to them in a secondand sharing their experiences.
(33:40):
Just a couple of the peoplethat are behind the scenes, that
you wouldn't know about it, butjust to get a sense, there's
something called the CRA orClinical Research Associate, and
these are counterparts that areusually on the sponsor side.
So if a drug company or devicemanufacturer or somebody that's
creating a lab test is going tohire us to help them do that
(34:01):
development work, then they havepeople that are constantly in
touch with us, helping us withwhatever questions may come up
and monitoring the progress ofthe study.
The sponsor is the person thatpays the bill.
The way these things work isthat we apply for a study grant
and basically the study grantswill say, ok, we're going to get
$100,000 to deliver data for 10patients and part of that
(34:27):
budget, by the way, goes to thepatients.
So we do negotiate that sumwhen we get these grants.
But we compete for grants witha lot of other similar sites
like ours around the country.
And then we have theInstitutional Review Board and
again they're an independentparty that looks at the data and
is also there if a questioncomes up.
So if there's a question aboutthe ethics of a study at any
(34:50):
point, our colleagues in theInstitutional Review Board help
us out.
So the reason we do these trialsis one to get the data that
provides the scientific evidenceas we talked about in the
beginning needed to determine ifa new intervention is safe and
effective, to understanddiseases and how they progress.
We learn incredible amountsfrom this.
(35:11):
Actually, one of the neatthings for me as a cardiologist,
as a curious, intellectuallycurious person, is that when I
do clinical trials I learn somuch about the disease area that
I didn't learn in medicalschool.
It really forces you tounderstand these things and the
questions that come up inclinical research are so
valuable for me to build myknowledge base.
(35:32):
You want to improve the qualityfor the life for patients, both
the patients that are in thestudy and the patients that get
the benefits, the results of thestudy and ultimately improve
health outcomes throughout theworld.
So we're going to now move toour volunteers and I'm going to
(35:53):
let Nalini kind of take over thequestioning here.
But I'm real curious if you canmaybe talk about what your
experiences are.
So, Nalini, go ahead.
Nalini Jones, BBA, CCRC (36:01):
Yeah, so we'll start with you.
Louise, how did you get intoclinical research?
Dorothy "Louise" Rohan (36:05):
I did.
My first research was oncontact lenses for bifocals, and
then I went to CNS research andI did a research on a
depression drug and I've beendoing research with JCCR since
(36:39):
2008.
And I can only say that I am soproud to be able to say that I
volunteer for this, because Ireally believe in being able to
give back and just be importanttowards something and the
medication, and it also helpsthat I have a degree in
hypochondria so, so-Dorothy "Louise" Rohan: Pardon
me,
Nalini Jones, BBA, CCRC (36:59):
I think my mother went to school with
you.
Dorothy "Louise" Rohan (37:00):
Oh, I'm sure she did.
I recognize you, yeah um, butI'm very happy to have to say I
am a volunteer and I urge anyonewho has a member of the family
or themselves that think theywould be interested to please
give it a try
Dr. Michael Koren (37:16):
Very nice.
Nalini Jones, BBA, CCRC (37:18):
That's lovely, and I want to say that
you were talking about how proudyou are to have participated in
so many trials with us and justto be a part of research, and
that's kind of the way we feelon the staff side as well.
Everybody can be a part of it,even if you think it's really
small.
What we're doing is for thegreater good and everything,
every study, every medication,even if the medication doesn't
(37:40):
get approved, we've learnedsomething medically,
scientifically, that's going tohelp them when they develop the
next medication.
So, Tony, how did you getstarted with JCCR?
Anthony Langhals (37:51):
Well, I was online and I don't know if it
was Facebook or just onlinewhere the JCCR, the research
clinic, needed volunteers fortheir studies.
So I went ahead and signed upand I got a call and they called
me in and they said oh, we gotthese studies available.
Which ones would you like to beinvolved in?
(38:12):
I said, well, which ones do Iqualify in?
So some of the studies thatI've been involved in is like
the flu study, fatty liver study, Moderna study study, and I'm
currently involved in the Vaxartstudy, where that is uh,
they're developing a pill to uhtake the place of a injection
(38:35):
vaccine for covid.
So you know, if you're a pillpopper, I think you'll like this
immensely, you know yeah,
Dr. Michael Koren (38:43):
Really cool technology
Anthony Langhals (38:44):
Exactly, yeah,
Dr. Michael Koren (38:46):
Instead of a shot for to protect people
against covid.
Anthony Langhals (38:49):
Yeah, and likewise, I just want to put out
that, uh, you know the staffthe doctors, nurses and
coordinators and staff arehighly qualified, competent and
professional.
They exhibit great concern andcare for the well-being of the
patients.
They're very personable andsociable and the studies that I
have been in you know they havea packet that you have to review
(39:16):
and, of course, sign and anyquestions I have, they fully and
expertly answer those questions.
So, like I say, the staff overthere at least, I know you've
got different sites (39:30):
Lane Avenue , Fleming Island.
Uh, you know, University by me,but you know the staff has just
been great, you know, uh,working with them
Nalini Jones, BBA, CCRC (39:40):
So I just want to jump in.
he mentioned the packet that hereceives.
That would be our informedconsent that everybody has to
sign if you haven't done aresearch study.
These forms can be a littlelengthy, but it tells you
everything about the study.
It tells you the purpose of thetrial.
It lets you know how manyothers hundreds or thousands are
going to be participatingaround the world with you.
It talks about the medicationin depth, the side effects that
(40:02):
we already know.
It's very transparent and italso has information about that
IRB, that Institutional ReviewBoard that Dr.
Koren mentioned.
It's in the packet with theirinformation because they are the
patient advocate.
So everything that we do iscompletely transparent.
Just to insert that and youmade a really good plug for the
rest of our sites, I think if wedo a commercial, we can have
(40:22):
Tony on it because, youadvertise for us very well.
Thank you, but we do.
We have locations on the westside of Jacksonville on Lane
Avenue, we have one in FlemingIsland, we're in St Augustine,
we have three locations inInverness and we do phase one
through phase four trials.
So we have something foreverybody and we are so grateful
that you guys continue to comeback to us.
I have a term, right.
(40:44):
I call you guys repeatoffenders, right, you just keep
coming back but then you alsobecome family to us.
Do you ever have thatexperience?
Is there anybody at our sitethat you've, or at any of our
sites that you guys have, kindof formed a relationship with?
Dorothy "Louise" Rohan (40:57):
I still keep in touch oh, I still keep
in touch with one of the ladiesthat I met there and, as I said,
I feel like they're family.
Nalini Jones, BBA, CCRC (41:10):
That's lovely.
Dr. Michael Koren (41:11):
Thank you.
David's up next.
Nalini Jones, BBA, CCRC (41:13):
Yeah.
So we know you've done vaccinestudies you, your wife, your
granddaughter.
Are you still currentlyparticipating in anything?
Dave Gnage (41:20):
Yes, I am.
I'm in a study right now thatmeasures changes in your voice
to see if there's a change in,if that can be an indicator of a
change in your heart.
Nalini Jones, BBA, CCRC (41:33):
Oh, the app.
Yeah, that's cool.
Dave Gnage (41:35):
I don't know what the official name is.
Yeah, can I say a little bitabout how I got interested?
Nalini Jones, BBA, C (41:41):
Absolutely .
Dave Gnage (41:42):
I spent my career in higher education and many times
I was working closely withpeople in the health fields and
one of them really struck me andthis was in the floor above
where my office was they weredeveloping new medications and
(42:06):
how they were using very smallamounts and technologies to
develop maybe 50, 60 differentalternative medications for a
particular disease or situationat a time.
But of course, then when theyidentified some that might work,
they went out into this process.
At the same time, I wasteaching statistics, so all
(42:29):
these methods, how youscientifically test whether a
drug or a process is successful.
I was teaching that, so Ithought okay, I'm retired, now
I'm here in Jacksonville, I'vegot an opportunity to pay back
all those people that took partin studies prior to this and
(42:55):
leave a legacy and I want tosince Tony said I took all his
time.
He took my time because he did agreat job of talking about the
relationship that we have withthe staff at the center and that
we kind of become a familytogether there,
Dr. Michael Koren (43:16):
Thank you
Nalini Jones, BBA, CCRC (43:17):
it's very nice
Dr. Michael Koren (43:18):
Yeah, so you made a couple points that I
found particularly interesting.
One, is the current study thatyou're in is actually a study of
technology, so it's to seewhether or not, by talking to
your phone, we can identifychanges in your heart status.
So not everything we do isinvolved drugs or devices.
It's actually more and moretechnologies that we're looking
(43:40):
at, so that's pretty cool, so Ilove that.
Excuse me, the other thing isthat you all mentioned this
concept of legacy as beingimportant to you, and that's
certainly one of the driversthat we see over and over again
and one of the reasons why wehave so many quote repeat
offenders.
So I think that's really,really cool.
Does anybody have an event thatyou can remember that like was,
(44:06):
maybe had a profound effect onyour day-to-day life or changed
the way you approach something?
Anthony Langhals (44:13):
Tony, yes, kind of give you a story.
I was in the Moderna study, thevaccine study 2020 timeframe,
and that's when COVID-19 wassweeping across the United
States and I'm in this study, Ivolunteered for it and I was
(44:37):
talking to my neighbor about mebeing in the study and getting
the vaccine and all this.
Well, it might have been aplacebo, but it was a vaccine
because I got some side effects.
But anyhow, I'm talking to himabout it.
He says no way will I get thisvaccine put in my body.
Okay, and I said well, you'reentitled to your opinion.
That's fine, you know.
But anyhow, about three, fourmonths later, he develops the
(45:01):
COVID symptoms and it got so badhe had to go to Memorial
Hospital, spent two, three weeksin Memorial Hospital being
treated for COVID symptoms.
Ok, and once he got, once hegot out, he came over to me and
he says Tony, man, I learned mylesson.
(45:22):
He says you know, you know, hesays what kind of vaccines are
out there?
I said, well, like you know,Moderna, Pfizer, Johnson
& Johnson, you know.
And he looks at me.
He says man, I'm ready to takethem all and my family will take
them all right now he says.
I just don't want to go throughthe experience of what I went
through with COVID for the two,three weeks that I was at
(45:45):
Memorial Hospital.
Dr. Michael Koren (45:46):
Yeah, that's a great story.
Thank you for sharing that.
Nalini Jones, BBA, CCRC (45:48):
Thanks for joining the MedEvidence
podcast To learn more head overto MedEvidence.
com or subscibe to the podcaston your favorite podcast
platform
Welcome to the MedEvidence podcast.
This episode is a rebroadcastfrom a live MedEvidence!
presentation.
Dr. Michael Koren (00:06):
Thank you very much.
I appreciate that, so we'regoing to do something different
today.
Who in the audience has been toone of our sessions before here
in this room?
Okay, most people.
Who has not?
Who's never been here?
Okay, that's good About.
Maybe 40% has not.
(00:26):
So, for those of you who havenot been here, what we usually
do is we present a particulararea of medicine it's often me
or somebody else with anotherexpert and we go through that.
So it could be an expert onintestinal diseases, or expert
neurologist, or an expert incongestive heart failure, and
(00:49):
then that person and myself willhave a conversation, with
audience input of course.
But we decided today to dosomething different.
Instead of talking about anarea of medicine, what we're
going to do today is just talkabout the overall research
process, Because in our othertalks we always allude to
(01:11):
research.
In fact, sometimes we go intodetails about research, and the
concept here is this MedEvidence concept that we want
everybody to understandinformation and we want you to
understand it from thisstandpoint.
In medicine most things in life,but particularly in medicine
there are things that we knowfor sure, there's things that we
(01:33):
definitely do not know, andthen there's a process to learn
about the things that we don'tknow.
So, in a simple case, whensomebody comes in to me as a
cardiologist and is having afunny pain this, that and the
other place I get an EKG and Ican tell you if you're having a
heart attack immediately, sothat I know; but I don't know
(01:55):
exactly what's causing yourchest pain, and then we figure
it out.
More broadly, everything inmedicine falls into that
category.
When you come in, whatever yourproblem is, there's stuff that
we know about it, there's stuffthat we don't know about it, and
there's a process to learn, andone of the most powerful
(02:18):
processes that we have to learnis clinical research, and the
three heroes here on stage haveall been part of that process
and they're going to share theirstories with you.
So I'm actually really excitedabout the interaction.
And then the person that makesthe heroes heroes is actually
sitting right next to me, NaliniJones, who is truly, I'm truly
blessed to have her as ourdirector at our large site on
(02:41):
University Boulevard inJacksonville.
Nalini is brilliant, she'scaring and she's an incredibly
good administrator, so she'sactually the manager that runs
the show day to day, and soshe's going to be here up with
me on the stage interacting withour guests and also to answer
questions from the standpoint,not of the physician,
(03:01):
necessarily, but of the personthat's kind of running the
day-to-day operations.
So that's who everybody is.
And why don't we just do this,Nalini just give us 30 seconds
on your background and soeverybody can hear your voice.
Nalini Jones, BBA, CCRC (03:14):
Sure .
Again.
My name is Nalini Jones and Iam the site director at the
Jacksonville Center for ClinicalResearch, the University
Boulevard location.
I've been with ENCORE Researchfor 26 years now, started as a
research assistant.
Dr. Michael Koren (03:27):
She started in utero, by the way, 26 years
Nalini Jones, BBA, CCRC (03:30):
I was born in the parking lot.
I've been there for a long time,worked my way up to a study
coordinator and then to a sitemanager, and it's been a very
rewarding experience for mepersonally, just because of the
blessings that we receive fromthe participants that come in to
work with us.
We can go more in-depth later,but you guys have always been a
(03:54):
huge part of the success of ourorganization.
Dr. Michael Koren (03:57):
So, Louise, introduce yourself, so everybody
can hear your voice.
Dorothy "Louise" Rohan (04:00):
Hi, I'm Dorothy Louise Rohan and I have
been in clinical research for anumber of years.
I've been with well, I think,as it was already stated, since
2008 with yes, and that is awonderful staff.
I cannot say enough about theemployees there.
(04:21):
They care for you as though youwere their family and I'm just
really proud and I feel gratefulto be a part of that,
Dr. Michael Koren (04:29):
Thank you, and we'll get into the
testimonials in a second,but tell everybody where you
grew up.
Dorothy "Louise" Rohan (04:35):
Oh, I grew up in a small town in
middle Tennessee and I'm a greatgrandmother and I'm married to
the most wonderful man that Godever created.
Dr. Michael Koren (04:47):
Wow Aw, I want to meet that guy.
David, you're up.
Dave Gnage (04:54):
My name's Dave Gnage .
I grew up in western New York,very close to Niagara Falls.
Dr. Michael Koren (05:01):
Are you still a Buffalo Bills fan?
Dave Gnage (05:03):
Absolutely a Buffalo Bills fan.
My uncle took me to the veryfirst Buffalo Bills game.
Dr. Michael Koren (05:09):
Wow
Dave Gnage (05:10):
Well, when they started in 1960.
I'm probably the oldest guy onthis platform today.
I'm married, we have a numberof kids and we have a
granddaughter who lives with usthat we're raising, and she
happens to be here today.
I've been in a number of studiesI started with.
(05:34):
Well, first of all, I wasreferred for some studies for
heart issues, but I didn't passthe test, which is good because
I was better than what theywanted.
But then the COVID test camealong, so I signed up for that
and my wife said well, I can dothat too.
(05:57):
So I was taking Pfizer and shesigned up for Moderna, I think.
And my granddaughter said well,if you're doing it, I want to
do it.
So if I could just go back alittle bit, when she came with
us, I thought she should learnthat people give blood for blood
(06:20):
tests.
So when she was about 10, Itook her to when I was having a
blood test I said come just seewhat goes on.
Well, when the needle came out,she ran out of the room.
But then, when she gotinterested in the test, I
explained that she's going tohave blood tests, have blood
(06:41):
tests, okay.
And she signed up and wasaccepted.
We went in for her first bloodtest and they numbed her arm a
little bit and I held her handand she was a trooper.
Well, she's been through threedifferent research projects and
(07:04):
by the time we got to the lastone, when it was time for a
blood test, she marches into theroom, puts her arm down.
They ask well, she didn't puther arm down.
They ask what arm do you wantto use?
And she pointed to me and saidhis,
Dr. Michael Koren (07:19):
That's a good line.
Thank you for that.
So the biggest question for youis your wife, half as good as
Louise's husband.
Dave Gnage (07:31):
Louise, she's better .
Dorothy "Louise" Rohan (07:33):
Oh.
We must keep them apart.
Dr. Michael Koren (07:38):
And how about you, Tony?
Are you married?
Anthony Langhals (07:40):
Yes, I am.
As a matter of fact, my name isTony Langels and my beautiful
wife.
She's sitting at the tablethere with the patriotic jacket
on.
Nice, all right so sheaccompanied me here tonight
today, but anyhow, I'm from Lima, Ohio and spent time with the
military, you know, 20 years.
But anyhow, I got to say youknow I had a long presentation
(08:03):
but, Dave, he took a lot of mytime here, you know.
Dr. Michael Koren (08:05):
So I kind of have to shorten mine, you know,
so that we get out of here.
We have plenty of time, but goahead, just tell us a little bit
about your background.
Okay, well, like.
Anthony Langhals (08:13):
I say I was in the military aviation with the
Navy and also I worked with AT&TBell South and Vistacon making
contact lenses.
So you know, know a little bitabout that.
But anyhow, you know, I went toUNF, graduated there, but I've
(08:34):
got to say I'm shocked at thelayout here.
I've never been here before inthe studio here, you know.
So you know I'm very impressedwith the layout and all the
attendance here.
So, and also I live on thesouth side, uh, real close to
the uh research center there, uh, Kennerly and University.
I could almost walk to it.
(08:55):
So, uh, it makes it convenientfor me to even get there.
So anyhow, uh, you know, I wantto thank Dr Koren for inviting
me to be up here and looking tohave a good time up here.
Dr. Michael Koren (09:08):
Well, thank you very much.
That's terrific.
So thank you for being on stage, and I'm glad that you all have
great spouses.
My story with regard to that ismy wife and I were happy for 25
years and then we met eachother.
All right, so people who havebeen here before know that
(09:31):
there's no such thing as a freelunch, and we like to get the
audience involved in thequestion and answers.
So we're going to start by thisfirst question.
By volunteering in a clinicaltrial, participants play a vital
role in A.
training robots to becomedoctors.
B keeping the coffee machinesrunning at clinical research
(09:54):
sites.
C.
contributing to scientificprogress that could benefit
countless others in the future.
D.
a plausible escape from anagging spouse.
You guys obviously don't haveto worry about that one.
Or E.
proving that laughter ismedicine but hard to get
(10:14):
approved by the FDA.
All right, you guys are good,absolutely.
C is the correct answer.
All right, you're so good.
We'll give you one.
More.
Benefits that patients canreasonably expect while
participating in a clinicaltrial include, A.
a lifetime supply of hospitalgowns.
B.
(10:36):
a cure for daytime insomnia.
C.
free Medications based onessential oils and moonlight.
D.
inside knowledge, stipends fortime and travel and a medical
legacy Sounds kind of AMedEvidence t-shirt.
(10:57):
If you behave yourself Well, Ithink we all know that D.
is the correct answer.
You can get a MedEvidencet-shirt, but you don't really
have to behave yourself.
All right.
So with that introduction, Ijust want to maybe spend 15
minutes giving everybody alittle bit of background about
how clinical research works, andthen we'll get back to the
(11:17):
discussion.
So there are basically two waysthat physicians make decisions.
One is called anecdotal and theother one is called
evidence-based.
And 50 years ago, virtually allmedical decisions were based on
anecdotes.
So a physician would be in asituation and they would
(11:38):
recognize the situation and theywould say, okay, well, in my
experience, this is what works.
Or, oh, I tried this for thelast five times and it seemed to
work, so let's try it again.
Or, oh my God, I tried this andit was horrible, so I'm not
going to try it again in you,even though some people think it
works.
So it was all based on anecdotes, but we've moved away from that
(12:00):
model as much as possible.
It still happens, but now wewant to do everything based on
evidence.
And when we say based onevidence, that means these are
things that are proven to workin a structured experiment or a
structured clinical trial.
And under those circumstanceswe say, okay, a thousand people
tried treatment A, a thousandpeople tried treatment B and
(12:24):
treatment A worked better thantreatment B.
So, doctors around the world,let's use treatment A and that's
the concept behindevidence-based medicine.
And we apply this to new drugdevelopment, to new procedures,
to new psychiatric methods.
This is ways that we do thingsand there's a whole process to
(12:45):
run clinical trials or researchin order to get evidence, so
physicians and otherpractitioners around the world
can make good decisions based onreal information rather than
just what they saw over the lastyear.
So this is a huge breakthroughin medicine and this concept is
ancient in some ways, but,believe it or not, it's only
(13:07):
been structured in its currentform since the 1970s and early
80s.
So prior to around 1980, it wasvery, very difficult to do a
really well-conducted structuredclinical trial.
But since 1980, which is lessthan 50 years ago, we now have
this incredible mechanism andtrained professionals like
(13:29):
Nalini Jones who know how to runthese studies, and this has
become a phenomenon throughoutthe US and other parts of the
world where we have people thatspend their entire career just
running clinical trials.
Now some doctors get trained inthat during medical school, but
most really don't.
And a subspecialty in medicineare people like me.
(13:52):
I practice cardiology.
I'm a fully trainedcardiologist and internist, but
I spent extra time learning howto run clinical trials.
So it's a subspecialty in andof itself, where the skill set
to run clinical trials issomething you apply to your
practice and help others do, aswe do have done here in
Jacksonville.
(14:12):
Now, evidence-based medicine inits current form evolved from a
lot of learning experiences, andwe like to call those learning
experiences the good, the badand the ugly, and sometimes
research gets a bad name.
People say, oh, you're a guineapig or you're just
experimenting on me, and thatbad name has sometimes come from
(14:33):
things that happened way in thepast, but again over the past
50 years.
This is now a highly ethical,highly structured, high quality
way of not only discovering thetruth for society, but always to
try to get the best outcomesfor our patients.
So throughout the process, oneof the ethical principles is
that we're always advocating forour patients, even if we're not
(14:56):
sure what arm of a study thatthey're in, and we're going to
go over some of those details.
So let's talk about the good.
So the concept of comparing twogroups is really an ancient one.
In fact it goes back to theBible, and there's a story from
the book of Daniel which talksabout when Daniel was
(15:17):
interfacing with the Babylonians.
He noticed that the Babylonianshad this really rich diet and
he mentioned that.
Well, let's compare whathappens if you eat the
Babylonian diet versus thehealthy diet.
And lo and behold, Daniel andhis disciples ate the healthy
diet and they stated, that after10 years, they felt great that
(15:40):
there was a big differencecompared to the Babylonian diet.
So this is the basic concept ofwhat's called randomization, or
comparing two groups, where onegroup does one thing and the
other group does another.
Obviously, current trials aremuch more sophisticated, but
this is an example of doingsomething in a structured way.
So it's an early example ofwhat we call the good.
(16:01):
Another example of the good isa really interesting project
which is considered the firstquote modern age clinical trial.
It's not really modern becauseit goes back to 1721.
But in the 16th and 17thcenturies and the 18th century
1721 would be the 18th centurysmallpox was absolutely
(16:25):
devastating.
So when smallpox hit acommunity, up to a third of the
people in the community died.
Imagine that.
So these were devastatingthings and people didn't know
what to do.
They weren't sure how to dealwith it, they didn't have any
good solutions, and it turnedout that they knew of what was
called inoculation, which is aconcept that actually came from
(16:49):
Turkey and Africa, where peoplewho got inoculated with the pus
of somebody who survivedsmallpox would be given that in
an injection, usually in theirleg, and they seemed to be
protected against smallpox whenit hit the community.
So this was considered a crazyidea.
(17:09):
Imagine going to a doctor andgetting a slash in your leg and
then putting pus in your leg.
But that was the concept ofinoculation.
So in 1721, everybody knew thatthere was this smallpox coming
to Great Britain.
One of the people in the royalfamily went to the king and said
(17:30):
we've got to do something.
I'm desperate, let's do thisinoculation.
Back in those days, of course,the concept was that prisoners
didn't have the same rights aseverybody else.
They went to the prisoners andthey took six people and they
said okay, this is what we'regoing to do.
We know that this epidemic iscoming and we're going to give
you this inoculation procedure.
In exchange for thatinoculation procedure, your
(17:52):
sentences will be commuted,you'll be free after that.
So, lo and behold, they gavethese six people inoculations,
and when the smallpox epidemicoccurred, they actually put
these people in the room withactive victims of smallpox and
none of them got sick.
And so this was the first timewhere people thought ahead,
(18:15):
identified a group of patients,prepared them with a medical
intervention and then showedthat it worked.
During the same epidemic, therewas a guy named Cotton Mather
who was one of the Puritans inMassachusetts, and a guy named
Onesimus who was an Africanslave, and they collaborated in
(18:38):
1721 on the exact same, duringthe exact same epidemic.
First it hit the UK, Britainand then it came to the United
States, of course, through theships, and they actually put in
over 200 patients from theMassachusetts colony and
inoculated them, and the peoplethat were inoculated had a death
rate of only 2% during thesmallpox epidemic, whereas if
(19:00):
you were not inoculated, yourlikelihood of dying was 16%.
So, again, this led to thislarger structured experiment in
the United States, which isinteresting a collaboration
between a Puritan minister andan African slave that helped the
people of Boston at that time.
So really, really cool stuff.
So we call this the good.
And again, these are not evenclose to the kind of structured
(19:23):
studies that we do these days.
But along the way, there's oneother thing All the inoculated
prisoners remain free ofsmallpox.
A couple little things.
Three of the prisoners end upback in jail for future crimes.
So that problem existed, butway back then, and one of the
patients actually lied.
(19:47):
So one of the patients in thisstudy actually never disclosed
the fact that she had smallpoxbefore, and because she had
smallpox before, it was very,very difficult for her to
actually get the proper reactionfrom the inoculation, which was
a sign that she was alreadyimmune to smallpox.
So that's why we go throughthis whole business about making
sure that we're getting theright patients into studies.
(20:09):
So let's talk about some of thenot-so-good stuff.
So who's here heard of thethalidomide babies?
Oh yeah, hopefully everybody.
Okay, so this was a drug thatwas highly marketed in Europe
that led to birth defects andthe typical thalidom.
My baby is an unfortunate childthat is born with no upper
(20:30):
extremities.
They're cut off toward theshoulder.
Ironically, a Germanpharmaceutical company was
marketing this for morningsickness for pregnant women, and
so this was a widely availabledrug in Europe in the 1950s and
early 1960s.
The German company tried to getthis done in the United States
and they hired 50 doctors to runa clinical trial of about 875
(20:55):
patients in the 1950s, and theprincipal investigators did this
study and they noticed that thedrug really didn't work very
well for what they wereadvocating it for.
So they were talking about itbeing for nausea, and it didn't
really help.
They were talking about itbeing something for insomnia it
really didn't help.
So the 50 principalinvestigators, after they
(21:16):
finished the study, didn't useit.
But in those days you didn'tneed to finish the trials before
a drug got approved.
So the German pharmaceuticalcompany sent the drug to 1,270
other doctors in the UnitedStates who used it in a couple
thousand patients.
So the United States wasbasically spared from the worst
of the thalidomide crisis, andthe reason for that was because
(21:40):
of a heroine named FrancisKelsey.
Dr.
Frances Kelsey, who was aphysician who worked for the FDA
, and she looked at the datafrom the clinical trial and the
German company was trying to getfull marketing approval in the
United States and she said no,this is not a good drug, this
should not be in the UnitedStates, and she blocked it.
And so when she blocked it andthe results came out that this
(22:03):
caused birth defects, it led toa very important law in the
United States, which was anamendment of the Food and Drug
Act in 1962.
And at that point that was thefirst really important
legislation that required theclinical trials to be completed
before you actually put the drugout in the marketplace.
So that was really an importantbreakthrough in terms of safety
(22:25):
.
And then an ugly incident issomething I'm sure most of you
have heard about, which is theTuskegee syphilis study, and
this study is really a horribleepisode of unethical behavior in
a study that was funded by theU.
S.
government.
It was actually originallyfunded by the chairman of Sears
(22:46):
Roebuck and he had sympathy forthe plight of poor people in the
rural South and wanted todonate some money for it, and he
wanted to study how syphiliswas affecting that population
before there was any treatmentfor syphilis.
So that started actually in thevery, very early 1930s.
(23:08):
And then the U.
S.
Public Health Service took overthe study when the private
grant ran out and they wanted tounderstand what happened in
syphilis.
So they enrolled about 400black men they were all very
poor sharecroppers withouteducation and then they had 200
or so uninfected controls andthey wanted to see what happened
over the course of their livesand how syphilis developed
(23:29):
complications.
Well, syphilis is untreated, isa horrible disease, ultimately
resulting in severe dementia anda number of other complications
.
The patients that were involvedin this were never told they
were being observed in a study.
They were just told that theyhad bad blood.
There was no consent process.
When the first antibiotics cameout, which was they weren't
(23:50):
very good in 1930s, but peoplewere using arsenic and bismuth
to try to treat infections, butthese unfortunate men were not
told about this.
When penicillin came out, theywere not told about it.
In fact, when this group ofpatients was being looked at for
participation in the military,when all the other recruits were
getting injections ofantibiotics, they were
(24:12):
specifically banned from gettingthose injections because they
didn't want to mess up theresearch.
So this was really, really bad.
And then the government, theCenters for Disease Control
actually looked at the study in1969, while they were still
following these people, and saidokay, let's keep on going.
And it wasn't until 1972, whenan expose came out in the
(24:32):
Washington Post, that peoplesaid what are you doing here?
You're subjecting these peopleto the rages of this disease.
That's very treatable at thispoint, and at that point it led
to the National Research Act in1974, which is really what
started the current modernclinical trial movement.
So after this, everybody thatwas going to be in a study had
(24:56):
to give written consent.
After this, everybody that's ina study had to be under the
watchful eye of an institutionalreview board.
So before we do any research,the researchers have to present
all the study methods to aninstitutional review board to
make sure it's completelyethical.
All this came out of thistragedy.
So there's a couple ofinteresting elements to this,
(25:18):
and one of the elements of it isthat it took so long for people
to respond to something thatshould have been so obvious.
That's horrible, but the otherthing is that it's created a lot
of racial tension.
There's a lot of people in theAfrican-American community that
haven't trusted research becauseof this story.
But it's actually more of acomplicated story than just
about race, because this wasactually conducted at a
(25:41):
historically black university,Tuskegee University, and there
were plenty of doctors andnurses that were part of the
study that were African American.
So it's really more, in myopinion, race is part of it, but
it was also socioeconomic isthat people that didn't have the
knowledge were being exploited,and that's a sad part of this
whole thing and that's one ofthe reasons why we have MedE
(26:03):
vidence and other things.
We want our people that getinvolved in research to be
really knowledgeable.
In fact, we want you to be moreknowledgeable than the average
consumer, because we see thatactually as a benefit of the
research, and this is certainlya learning that happened through
these historical incidences.
So this gets into the conceptof who's looking out for you.
(26:24):
So, as we know, we have theFood and Drug Administration and
that's an administrative bodyof the federal government and
again, as mentioned, FrancisKelsey was a true pioneer who
got the point across to theauthorities that you really need
to look at all the researchdata in a very structured way
before you approve a drug.
(26:45):
And now the process of getting adrug approved is a mammoth
process.
It takes tens of thousands ofpeople to do this tens of
thousands of volunteers andthousands of scientists and
nurses and other people that areall part of this process, and
it's a very expensive processright now, but it assures the
safety and throughout this we'reconstantly sharing information.
(27:07):
So we have a process, forexample, called a serious
adverse event report and theresponsibility of a physician
like me.
If I learn of a strange sideeffect in somebody that's
involved in the study, Iimmediately have to send that
information to the Food and DrugAdministration and it's
immediately disseminatedthroughout the world.
So I come into my office everymorning and I get reports from
(27:28):
all over the world about whatcould possibly go wrong and
whether or not the doctorsinvolved there thought it was
related to the study or not.
It's almost never related tothe study medication, but I get
all this information and if Isee something that's relevant to
my patients, I can share itwith the patients.
So it's a cool part of theprocess.
I mentioned the IRB,Institutional Review Board.
(27:49):
Their sole goal is just to makesure that everything is done
ethically and then, whateverpossible, there will be a
benefit to the patients forparticipating in clinical
research.
And then you have excuse me, youhave your investigators, like
myself, many of whom arecertified.
I'm a certified principalinvestigator.
That's like being boardcertified in cardiology.
(28:10):
I have that certificate forclinical research and we are
knowledgeable people that lookout for our patients and can
share insights that willhopefully not only affect you in
that study but help you withother elements of your life,
other medical issues, and we'lltalk more about that momentarily
.
So when you get involved in aclinical trial, you can get
(28:32):
involved in different stages.
So before any study gets donein human beings, we look at it
in animals, in test tubes, allkinds of analyses.
So nowadays this preclinical,pre-patient information is so
accurate and so valuable that wereally screen out most of the
side effects before a patienteven touches that.
(28:54):
Not 100%, but there's a reallyreally good screening process
before any patients getsubjected to any of these
medications that we use orprocedures.
It doesn't have to be amedication.
But then, once it gets past thepreclinical, then we have these
phases phase one, two and three.
So phase one is called first inhuman phase.
So this is where you'll come inand for the first, maybe 100
(29:19):
patients that ever get a product.
They are monitored 24/7 for aperiod of time it could be a
week or two.
Any curiosity has anybody heredone a phase one study as a
volunteer?
We have one, so we might okay acouple.
That's nice.
(29:39):
So that's the first in humantype of work and we do that in
Jacksonville in our organization.
We also do it in Inverness,Florida, in our organization,
and we have sister sites in SanAntonio, texas, in Orlando, that
also do it.
So this is again first inhumans, where you come in and we
look at you really, reallycarefully.
You're constantly monitored andwe want to make sure that it's
safe in the first hundred or sopatients that get exposed to a
(30:00):
particular product.
Then, after phase one, you goto phase two.
That typically involvesanywhere between 200 and 500
patients and that's when you getthe dose right.
So in phase two you have to seeis the dose 1 milligram or 50
milligrams and we look at anumber of factors to make that
ultimate determination.
And then, once phase two iscompleted and the company
(30:23):
decides that they really want toinvest in the product, which
now is going to be a hugeinvestment, they go to phase
three and that's when you takethe dose that you're going to
actually use and try to getregulatory approval.
And that typically involvesthousands, if not tens of
thousands, of patients.
So just to give you a littleinsight, I do a lot of work with
cholesterol drugs and the firstcholesterol drug that was
(30:47):
approved in the United Stateswas called Lovastan and that was
approved in a study of about800 patients.
That was before I was active.
That got approved actually as Iwas in medical school.
Then I was active in thebeginning in the mid-1990s, and
(31:08):
the big drug that got developedthen was atorvastan or Lipitor,
and I was very involved withthat and actually that's a drug
that was developed inJacksonville to a large degree.
13% of all patients who wereexposed to atorvastan before it
was approved by the FDA camefrom Northeast Florida, in part
because of the work that me andmy colleagues did here and that
(31:28):
involved 3,000 patients.
So we went from 800 for thefirst drug to 3,000.
Lipitor is the fifth drugactually in the class and then
Crestor or rosuvastatin had12,000 patients to get approval.
So more and more patients,despite the fact that we even
have more and more experience inthe class and now the studies
that we're doing for these newcholesterol drugs involve 20,000
(31:51):
patients.
So there's a lot of informationthat we get before these drugs
are approved, but with thatthere's a lot of opportunity for
being involved and the benefitsfrom all that.
Phase four is the term that weuse once a drug has been
approved by the FDA, and this iswhat we call post-marketing
studies.
And there's even a phase fiveright now, which gets into all
(32:14):
the pharmaco-economics.
So when you have a situationwhere you're dealing with
expensive drugs, who gets them?
Some of these new drugs areusing these incredible
technologies, nobel Prizewinning technologies.
They're very sophisticated,they're very expensive to
manufacture and not everybodycan afford them.
So how do we decide who getswhat?
And that's considered a phasefive study.
(32:36):
So who are the players?
Well, I'm a principalinvestigator and my job is to
lead the team and to be a voiceof reason, hopefully, but also
somebody that has the medicalknowledge to answer questions
when they come up, especiallyquestions around, "could this be
a side effect?
Or, oh, my other doctor put meon this drug.
(32:57):
Is it still safe for me to bein the trial?
These are the questions that weget all the time.
Then you have clinical researchcoordinators like Nalini and
her team, who really are doingthe bulk of the work.
Quite frankly, so, they're thepeople that literally are
meeting the patients, schedulingthe patients and then
collecting all the informationand they work with teams.
They have helpers that do dataentry and other things, but
(33:19):
they're the core day-to-daypeople that are doing the work
and of course, I'm around ifthey need my help, which is
actually relatively infrequentbecause they're so good, but
when they're new they would needour help more.
But these are the people thatare doing the day-to-day stuff.
And then, most importantly, thevolunteers and we're going to
be talking to them in a secondand sharing their experiences.
(33:40):
Just a couple of the peoplethat are behind the scenes, that
you wouldn't know about it, butjust to get a sense, there's
something called the CRA orClinical Research Associate, and
these are counterparts that areusually on the sponsor side.
So if a drug company or devicemanufacturer or somebody that's
creating a lab test is going tohire us to help them do that
(34:01):
development work, then they havepeople that are constantly in
touch with us, helping us withwhatever questions may come up
and monitoring the progress ofthe study.
The sponsor is the person thatpays the bill.
The way these things work isthat we apply for a study grant
and basically the study grantswill say, ok, we're going to get
$100,000 to deliver data for 10patients and part of that
(34:27):
budget, by the way, goes to thepatients.
So we do negotiate that sumwhen we get these grants.
But we compete for grants witha lot of other similar sites
like ours around the country.
And then we have theInstitutional Review Board and
again they're an independentparty that looks at the data and
is also there if a questioncomes up.
So if there's a question aboutthe ethics of a study at any
(34:50):
point, our colleagues in theInstitutional Review Board help
us out.
So the reason we do these trialsis one to get the data that
provides the scientific evidenceas we talked about in the
beginning needed to determine ifa new intervention is safe and
effective, to understanddiseases and how they progress.
We learn incredible amountsfrom this.
(35:11):
Actually, one of the neatthings for me as a cardiologist,
as a curious, intellectuallycurious person, is that when I
do clinical trials I learn somuch about the disease area that
I didn't learn in medicalschool.
It really forces you tounderstand these things and the
questions that come up inclinical research are so
valuable for me to build myknowledge base.
(35:32):
You want to improve the qualityfor the life for patients, both
the patients that are in thestudy and the patients that get
the benefits, the results of thestudy and ultimately improve
health outcomes throughout theworld.
So we're going to now move toour volunteers and I'm going to
(35:53):
let Nalini kind of take over thequestioning here.
But I'm real curious if you canmaybe talk about what your
experiences are.
So, Nalini, go ahead.
Nalini Jones, BBA, CCRC (36:01):
Yeah, so we'll start with you.
Louise, how did you get intoclinical research?
Dorothy "Louise" Rohan (36:05):
I did.
My first research was oncontact lenses for bifocals, and
then I went to CNS research andI did a research on a
depression drug and I've beendoing research with JCCR since
(36:39):
2008.
And I can only say that I am soproud to be able to say that I
volunteer for this, because Ireally believe in being able to
give back and just be importanttowards something and the
medication, and it also helpsthat I have a degree in
hypochondria so, so-Dorothy "Louise" Rohan: Pardon
me,
Nalini Jones, BBA, CCRC (36:59):
I think my mother went to school with
you.
Dorothy "Louise" Rohan (37:00):
Oh, I'm sure she did.
I recognize you, yeah um, butI'm very happy to have to say I
am a volunteer and I urge anyonewho has a member of the family
or themselves that think theywould be interested to please
give it a try
Dr. Michael Koren (37:16):
Very nice.
Nalini Jones, BBA, CCRC (37:18):
That's lovely, and I want to say that
you were talking about how proudyou are to have participated in
so many trials with us and justto be a part of research, and
that's kind of the way we feelon the staff side as well.
Everybody can be a part of it,even if you think it's really
small.
What we're doing is for thegreater good and everything,
every study, every medication,even if the medication doesn't
(37:40):
get approved, we've learnedsomething medically,
scientifically, that's going tohelp them when they develop the
next medication.
So, Tony, how did you getstarted with JCCR?
Anthony Langhals (37:51):
Well, I was online and I don't know if it
was Facebook or just onlinewhere the JCCR, the research
clinic, needed volunteers fortheir studies.
So I went ahead and signed upand I got a call and they called
me in and they said oh, we gotthese studies available.
Which ones would you like to beinvolved in?
(38:12):
I said, well, which ones do Iqualify in?
So some of the studies thatI've been involved in is like
the flu study, fatty liver study, Moderna study study, and I'm
currently involved in the Vaxartstudy, where that is uh,
they're developing a pill to uhtake the place of a injection
(38:35):
vaccine for covid.
So you know, if you're a pillpopper, I think you'll like this
immensely, you know yeah,
Dr. Michael Koren (38:43):
Really cool technology
Anthony Langhals (38:44):
Exactly, yeah,
Dr. Michael Koren (38:46):
Instead of a shot for to protect people
against covid.
Anthony Langhals (38:49):
Yeah, and likewise, I just want to put out
that, uh, you know the staffthe doctors, nurses and
coordinators and staff arehighly qualified, competent and
professional.
They exhibit great concern andcare for the well-being of the
patients.
They're very personable andsociable and the studies that I
have been in you know they havea packet that you have to review
(39:16):
and, of course, sign and anyquestions I have, they fully and
expertly answer those questions.
So, like I say, the staff overthere at least, I know you've
got different sites (39:30):
Lane Avenue , Fleming Island.
Uh, you know, University by me,but you know the staff has just
been great, you know, uh,working with them
Nalini Jones, BBA, CCRC (39:40):
So I just want to jump in.
he mentioned the packet that hereceives.
That would be our informedconsent that everybody has to
sign if you haven't done aresearch study.
These forms can be a littlelengthy, but it tells you
everything about the study.
It tells you the purpose of thetrial.
It lets you know how manyothers hundreds or thousands are
going to be participatingaround the world with you.
It talks about the medicationin depth, the side effects that
(40:02):
we already know.
It's very transparent and italso has information about that
IRB, that Institutional ReviewBoard that Dr.
Koren mentioned.
It's in the packet with theirinformation because they are the
patient advocate.
So everything that we do iscompletely transparent.
Just to insert that and youmade a really good plug for the
rest of our sites, I think if wedo a commercial, we can have
(40:22):
Tony on it because, youadvertise for us very well.
Thank you, but we do.
We have locations on the westside of Jacksonville on Lane
Avenue, we have one in FlemingIsland, we're in St Augustine,
we have three locations inInverness and we do phase one
through phase four trials.
So we have something foreverybody and we are so grateful
that you guys continue to comeback to us.
I have a term, right.
(40:44):
I call you guys repeatoffenders, right, you just keep
coming back but then you alsobecome family to us.
Do you ever have thatexperience?
Is there anybody at our sitethat you've, or at any of our
sites that you guys have, kindof formed a relationship with?
Dorothy "Louise" Rohan (40:57):
I still keep in touch oh, I still keep
in touch with one of the ladiesthat I met there and, as I said,
I feel like they're family.
Nalini Jones, BBA, CCRC (41:10):
That's lovely.
Dr. Michael Koren (41:11):
Thank you.
David's up next.
Nalini Jones, BBA, CCRC (41:13):
Yeah.
So we know you've done vaccinestudies you, your wife, your
granddaughter.
Are you still currentlyparticipating in anything?
Dave Gnage (41:20):
Yes, I am.
I'm in a study right now thatmeasures changes in your voice
to see if there's a change in,if that can be an indicator of a
change in your heart.
Nalini Jones, BBA, CCRC (41:33):
Oh, the app.
Yeah, that's cool.
Dave Gnage (41:35):
I don't know what the official name is.
Yeah, can I say a little bitabout how I got interested?
Nalini Jones, BBA, C (41:41):
Absolutely .
Dave Gnage (41:42):
I spent my career in higher education and many times
I was working closely withpeople in the health fields and
one of them really struck me andthis was in the floor above
where my office was they weredeveloping new medications and
(42:06):
how they were using very smallamounts and technologies to
develop maybe 50, 60 differentalternative medications for a
particular disease or situationat a time.
But of course, then when theyidentified some that might work,
they went out into this process.
At the same time, I wasteaching statistics, so all
(42:29):
these methods, how youscientifically test whether a
drug or a process is successful.
I was teaching that, so Ithought okay, I'm retired, now
I'm here in Jacksonville, I'vegot an opportunity to pay back
all those people that took partin studies prior to this and
(42:55):
leave a legacy and I want tosince Tony said I took all his
time.
He took my time because he did agreat job of talking about the
relationship that we have withthe staff at the center and that
we kind of become a familytogether there,
Dr. Michael Koren (43:16):
Thank you
Nalini Jones, BBA, CCRC (43:17):
it's very nice
Dr. Michael Koren (43:18):
Yeah, so you made a couple points that I
found particularly interesting.
One, is the current study thatyou're in is actually a study of
technology, so it's to seewhether or not, by talking to
your phone, we can identifychanges in your heart status.
So not everything we do isinvolved drugs or devices.
It's actually more and moretechnologies that we're looking
(43:40):
at, so that's pretty cool, so Ilove that.
Excuse me, the other thing isthat you all mentioned this
concept of legacy as beingimportant to you, and that's
certainly one of the driversthat we see over and over again
and one of the reasons why wehave so many quote repeat
offenders.
So I think that's really,really cool.
Does anybody have an event thatyou can remember that like was,
(44:06):
maybe had a profound effect onyour day-to-day life or changed
the way you approach something?
Anthony Langhals (44:13):
Tony, yes, kind of give you a story.
I was in the Moderna study, thevaccine study 2020 timeframe,
and that's when COVID-19 wassweeping across the United
States and I'm in this study, Ivolunteered for it and I was
(44:37):
talking to my neighbor about mebeing in the study and getting
the vaccine and all this.
Well, it might have been aplacebo, but it was a vaccine
because I got some side effects.
But anyhow, I'm talking to himabout it.
He says no way will I get thisvaccine put in my body.
Okay, and I said well, you'reentitled to your opinion.
That's fine, you know.
But anyhow, about three, fourmonths later, he develops the
(45:01):
COVID symptoms and it got so badhe had to go to Memorial
Hospital, spent two, three weeksin Memorial Hospital being
treated for COVID symptoms.
Ok, and once he got, once hegot out, he came over to me and
he says Tony, man, I learned mylesson.
(45:22):
He says you know, you know, hesays what kind of vaccines are
out there?
I said, well, like you know,Moderna, Pfizer, Johnson
& Johnson, you know.
And he looks at me.
He says man, I'm ready to takethem all and my family will take
them all right now he says.
I just don't want to go throughthe experience of what I went
through with COVID for the two,three weeks that I was at
(45:45):
Memorial Hospital.
Dr. Michael Koren (45:46):
Yeah, that's a great story.
Thank you for sharing that.
Nalini Jones, BBA, CCRC (45:48):
Thanks for joining the MedEvidence
podcast To learn more head overto MedEvidence.
com or subscibe to the podcaston your favorite podcast
platform
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