July 10, 2025 • 28 mins
Dr. Kevin J. Tracey, President and CEO of the Feinstein Institute for Medical Research at Northwell Health and Director of the Laboratory of Biomedical Science, discusses how bioelectronic medicine could transform how we treat inflammation and immune disorders. 🧬💡
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
SPEAKER_00 (00:00):
Welcome to the Tomorrow's World Today podcast.
We sit down with experts, worldchanging innovators, creators
and makers to explore howthey're taking action to make
tomorrow's world a better placefor technology, science,
innovation, sustainability, thearts and more.
On this episode, host GeorgeDavison, who is also the host of
(00:21):
the TV series Tomorrow's WorldToday, sits down with Dr.
Kevin Tracy, a renownedneurosurgeon and the president
and CEO of the FeinsteinInstitutes for Medical Research.
Dr.
Tracy explores the critical roleof inflammation in the vagus
nerve in our health and unveilsa groundbreaking solution, a
tiny device designed to tackleinflammation at its core.
SPEAKER_01 (00:43):
Welcome everybody to another edition of Tomorrow's
World Today.
And today we have Dr.
Tracy.
He's a special guest of ours.
And I'd like to introduce him toall of you.
Dr.
Tracy, welcome.
Thank you for having me on.
It's great to be here.
Could you tell us a little bitabout the name of your company
and what you do?
It's so unique.
I'm the president of theFeinstein Institutes at
(01:04):
Northwell Health.
The Feinstein Institutes is theresearch home for the largest
healthcare system and privateemployer in New York.
I hear it's quite a bigoperation.
How many employees are wetalking?
Northwell employs about 110,000people now and provides care to
2 million patients a year.
Within the research enterpriseat the Feinstein Institutes, we
(01:26):
have about 100 laboratories withprofessors, faculty, and about
5,000 team members.
So it's a big operation.
And what's your role with allthis?
So as the president of theresearch arm, the Feinstein
Institutes, I also run mylaboratory with my colleague
Sangeeta Shivan, and we focus onwhat we call bioelectronic
(01:47):
medicine.
That's the area where we studyhow the nervous system, the
brain, controls the immunesystem, and we work on making
computer chips and nervestimulators to treat
inflammation.
Isn't that wonderful?
I mean, inflammation is a bigproblem.
I've learned a lot.
Well, first, I've seen it in ourfamily, and then I've had to
(02:07):
learn a lot more about it as Istarted to study up your
organization.
It's a bigger problem than manypeople realize.
If you look at the 60 millionpeople on planet Earth who die
every year, 40 million of themdie of conditions like heart
disease and stroke, diabetes,obesity, metabolic syndrome,
Alzheimer's disease,neurodegeneration, and even
(02:29):
cancer.
All of these conditions areeither caused by inflammation or
made worse by it.
And so the real question is ifinflammation is contributing to
two-thirds of the deaths onEarth every year, what if we
could treat inflammation?
What if we could stop itcompletely in its tracks?
What would that do to thoseother conditions?
(02:50):
And so those are the kinds ofquestions my colleagues and I
are studying now.
And could you walk us back intime a little?
I mean, you didn't start at thispoint in your career, you know,
and just arrive here.
Something must have got youstarted on this adventure.
Can you walk us back through howthis started to happen in your
life?
(03:10):
How far back do you want to go,George?
Well, it's like when you'reinnovating or you're inventing,
usually something impacts yourlife.
Maybe you saw something, youheard something, you made an
observational analysis, right,out of science, and something
moved you and has now taken youinto this career.
The specific events, twospecific events moved me into
(03:33):
the career path.
And one unexpected discovery inthe laboratory led to this major
path I'm on now.
So the two unexpected lifeevents were the death of my
mother when I was five of abrain tumor, which inspired me
to believe that I wanted tospend my life in neurosurgery
(03:53):
and in inventing things thatmight lead to therapies for when
I was young for other kids,mothers, and ultimately not for
other mothers, but for allothers.
Understood.
That's a hard thing to face as ayoung person.
But I'll tell you, you know,what a noble cause.
(04:15):
Well, you know, when you're myage now and have spent 40 years
pursuing something you love todo, it's interesting to look
back and connect the dots.
Whether there's cause andeffect, as you know, is always
up to debate.
But something, did cause mespecifically to become
interested in inflammation.
And that was another death of alittle girl this time when I was
(04:38):
training to be a neurosurgeonwho died in my arms of a
household accident, a burninjury.
And I was haunted by her deathbecause we couldn't explain why.
She had been recovering fromthis burn injury and suddenly
went into shock and died.
And we deduced it was from someunseen infection, but we
(04:58):
couldn't explain it.
And so, as I had alreadycommitted to a career in science
and neurosurgery, I hadn'tcommitted to a choice of what I
would study in the lab.
And when Janice died, I decidedI would try to study
inflammation and figure out whatled to her death.
So that was the second choice.
That was the second event.
But those were the two eventsthat pushed me onto the career
(05:22):
path.
The unexpected discovery thatled to what we hope now is a
revolutionary new therapy formillions of people, that
happened in the lab, you know,surreptitiously, accidentally,
unintended consequences.
And that was the day we wereputting...
an anti-inflammatory moleculeinto the brains of rats to study
(05:42):
how it would stop inflammationin the brain, which is what we
expected would happen and didhappen.
What we didn't expect is thatthe presence of these molecules
in the brain stoppedinflammation in the body of the
rat.
This was a total shocker and itwas inexplicable.
It took us at first months andsubsequently years to explain
(06:04):
what had happened, but what welearned is that that the brain
sends signals to the body tostop inflammation and based on
that, we've now been able toreduce this idea into a therapy
using a computer chip thatcontrols the nerves that control
the immune system to stopinflammation.
And we've now seen this hashelped successfully in a
(06:28):
clinical trial, patients withrheumatoid arthritis.
And we're, as you and I arespeaking, we're waiting on the
FDA's decision, which I fullyexpect will lead to the approval
for this idea in the UnitedStates as one of the treatments
for rheumatoid arthritis.
That's a great, great moment intime.
Thank you for your work.
For this audience, though, I'dlike to...
(06:48):
Let's...
Give them a little more clarity.
They may not be so familiar withinflammation.
And is there something that thebody naturally does that brings
inflammation on?
What is this moment, thistrigger that causes this?
Do you know?
We've known for centuries,dating back to the first
physician scientist, Galen, inancient Rome, who taught us that
(07:10):
inflammation is the body'sreaction to injury or infection.
So if you scratch yourself, evenif you do it with the tip of a
of a ballpoint pen, you'll seethe redness, the swelling, the
pain that occurs when youinjure, even gently injure the
skin.
And similarly with an infection.
You get an infected pimple, yousee the pain, you see the
(07:31):
swelling, the redness, the heat.
So that's what inflammation is.
Why do we have inflammation?
Because it is very importantdefensive mechanism to ward off
infection and to facilitate, toincrease the rate of healing of
an injury.
So the right amount ofinflammation in the right time
in the right place is verybeneficial.
(07:53):
And we know this because inconditions where people are
immunosuppressed and they don'thave enough inflammation, then
their bodies are susceptible todamaging injury and infection.
They can actually be very, veryserious.
So inflammation is a good thingto start.
But if it persists, if itdoesn't stop, if it ramps up, if
(08:15):
the inflammation becomes rampedup to a high level, now it can
actually damage normal organssuch as the kidneys such as the
lungs and even the heart andbrain and when that happens now
inflammation becomes the problemnot the beneficial solution so
this let's call it accidentaldiscovery You know, it's one of
(08:39):
those things.
There are a lot of inventionslike that.
Vulcanized rubber happened thatway.
Penicillin.
Penicillin happened that way.
I mean, but if you're not tryingand if you're not looking, you
know, then things can kind ofpass you by.
So was it lightning in a bottlethat you happened to discover
(09:01):
it, or is there a system thathas been set in the lab to make
sure everything is alwaysmonitored and seen and tested?
I think it's a little of theformer, but much more of the
latter.
I think there's lots of ways ofdoing invention and science, and
there's lots of ways of doingart and creativity, but they
come together around having agoal, a desire, a personal
(09:27):
philosophy to do something thatwould lead to, in the case we're
talking about now, lead to atherapy or a cure.
And so when something unexpectedhappens, rather than say, that's
not what I expected, throw thatexperiment away and do it over
again until you get what youexpect, every time something
unexpected happens is theopportunity to say, what if it's
(09:49):
true?
And what if there's analternative path to that goal
that I hadn't thought of beforeand maybe no one had thought of
before?
And then you have to imagine.
Remember Albert Einstein said,imagination is more powerful
than knowledge.
Now you have to imagine analternate route.
Instead of around the mountainor over the mountain, what if we
(10:10):
could go through the mountain?
And there's a lot teamed upagainst that approach.
There's a lot of pressure.
There's a lot of dogma.
There's a lot of history.
Well, this is how it is.
I don't know if it's a flash oflightning, but the flash of
insight comes when you say, oh,I can go through the mountain.
(10:32):
And if I went through themountain, that would solve this
problem.
That creates a new set ofchallenges.
How the heck are we going to gothrough the mountain?
And that's the next step.
But in the lab, the key is,having thought about going
through the mountain, the nextstep is, what is the experiment
I can do?
And it's usually only oneexperiment.
(10:54):
What's the experiment I candesign and do that if it works,
will convince not only me, buteverybody else, oh yeah, you can
go through the mountain.
And that's what we focus oureffort on next.
And in the case of thisexperiment, where we had this
accidental result wheresomething, a molecule in the
brain stopped inflammation inthe body, the experiment that
(11:14):
was told us we could go throughthe mountain was we put a an
electrode on the vagus nerve,which connects the brain to the
spleen and other organs.
And when we activated thatcircuit, like the brakes in your
car, it stopped inflammation.
So that was in the late 1990s,and that changed everything for
(11:36):
me and my colleagues, hundredsof colleagues who've now worked
on that in my lab and also atlaboratories around the world
ever since.
So the discovery of a...
So it's nature combined with youknow, man-made devices that
you're blending together toinvent something that hasn't
been created before to vibrate aspecific nerve in the body that
(12:00):
will then shut off theinflammation from manufacturing
more inflammation.
Exactly right.
Hundreds of millions of years ofevolution perfected a control
mechanism for the brain to stopinflammation at the right
amount.
Yes.
And that makes perfect sensebecause if you're evolving in
ancient animals, if you'reevolving over millions of years,
(12:23):
an immune system that has thecapacity to do tremendous
damage, then the pressure isalso on those organisms to
evolve a neural mechanism tocontrol it in a healthy way.
So absolutely evolution tookcare of inventing and producing
this hardwired neural circuitthat acts like the brakes on
your car to stop inflammation.
Silicon Valley and modernneuroscience and modern
(12:47):
understanding of molecularbiology gave us the tools to
connect the dots so we couldbuild a computer chip that would
target those fibers specificallyto activate them.
Activating the fibers stopsinflammation because like when
you activate the brakes in yourcar, it slows down your car.
What a great discovery.
(13:07):
It's very interesting now.
Even having worked on it for 25years, it gets more interesting
every day.
As a side note, in the field ofpain management, I had shoulder
surgery.
And after surgery, they want toget you moving.
Well, I couldn't get my armvery...
I couldn't get it above here.
(13:28):
And the therapist takes all thisice, he puts it on my shoulder,
right?
And within 10 minutes, he has myarm up over my head and and I
was observing him while he wasdoing this you know I'm like I
love science I'm watchingeverything he's doing wait he's
tapping the ice bag as he'smoving it right and I'm thinking
(13:48):
well this is kind of strange Icouldn't move my arm before but
he's just tapping an ice bag andI Apparently, the pain receptors
don't know how to deal withvibration and cold, which I just
found intriguing.
So I came back to Inventionland,and I sat down with the guys,
(14:08):
and I said, we're going to builda vibrating ice bag.
And so we built this thing,right?
And I went back for therapy, andI said, hey, Doc, look at what I
created here, you know?
And he put it on, and we usedit.
And he's like, this thing reallyworks.
And I said, yeah, isn't itgreat?
So I said, well, he's like, no,no, no, you're not taking this.
(14:28):
This is staying here.
It'll never leave here, George.
I said, I have the engineeringfiles.
We can make another one.
But it was just anotherobservation, discovery moment.
It's very different thaninflammation, but still pain
observing the body, tying ittogether with mechanical
devices.
It's not different thaninflammation.
(14:50):
Really?
Inflammation and pain gotogether.
All right.
Yeah, the question really is,What is pain?
And can you have pain in theabsence of inflammation?
And that's an incrediblyimportant question in
neuroscience and in immunologyright now.
If you recall the definitionfrom Galen 2,000 years ago after
injury or infection, it's pain,swelling, heat, and redness.
(15:14):
And when you have pain, injuryor infection, white blood cells
come in and they releasemolecules that create these
inflammatory responses.
Those molecules produce painbecause they interact with
neurons.
But here's the kicker.
Neurons also make thosemolecules.
So when someone asks me, what'sthe difference between the
(15:35):
nervous system and the immunesystem, I say, I'm not sure.
They're both capable of makingmemories.
They're both capable of causingpain.
Yes, I can see that.
When you say memories, you meanas in, like in my situation, it
would be muscle memory.
Is that what you mean?
Or memory of a specific virus orinfection that you get.
(15:55):
So when you get exposed to avirus or a bacteria, your immune
system comes in.
If it's never seen it before, itdeals with it.
You might be sick from theinflammation that's occurring
from the immune response to thevirus or the bacteria, but it
also makes what are calledmemory cells, and it makes
antibodies.
Now, the next time that you seethat virus or that bacteria,
(16:16):
your immune system immune systemmemory cells come to life very,
very quickly.
And you don't have the sameresponse.
In fact, sometimes you havealmost no response.
That's how vaccines work.
Vaccines produce memory cells.
So the immune system is capableof producing memory.
Your brain, obviously, iscapable of producing memory.
When it's injured frominflammation in the course of
(16:36):
Alzheimer's disease.
So it's, let me say it in, maybenot in the neuroscience way, but
it's saying, I've seen thisbefore and I know what to do so
I can move rapidly to solve aproblem rather than I haven't
seen this before and I'm not sosure how to solve it so it's
going to take me longer but I'llsolve it I thought you said you
weren't going to explain it inthe neuroscience way that is the
(16:59):
explanation really okay wellyou're explaining it well thank
you and I'm sure our audience isthankful too well I did write a
book about all this it's calledThe Great Nerve which is what
Galen called The Vegas Nerve andI think there's one more
important piece of explanationsince we're down to this level
of details So we call it thevagus nerve, but you actually
have two, like two thumbs andtwo kidneys.
(17:22):
And actually within each one ofthese two nerves, which runs
from about the level of your earthrough your neck down into all
the organs of your body, youactually have on each side
100,000 fibers.
So you said before that thesestimulators vibrate the neurons.
They actually do vibrate alittle bit, even when you
(17:42):
stimulate them with electricalinputs.
But we estimate of the 200,000fibers you have, 100 on each
side, we estimate that probablyaround 1,000 or 2,000 control
the immune system or theinflammatory response.
We call that the inflammatoryreflex.
So the obvious question is, whatare the other 198,000 fibers
(18:02):
doing?
So it's a very complicatedsystem, and we're
systematically, my colleaguesand I in labs around the world,
actually, are systematicallyworking through what each and
every one of those fibers does.
George, as an inventor, each andevery one of of those fibers or
groups of fibers, may be thesource of future inventions for
different conditions.
(18:23):
That makes sense.
I'm sure they're performing somefunction.
We know that they have specificorigins and insertions.
We know they have specificroots.
We know they carry specificmessages.
My colleague at Harvard, SteveLiberlis, has actually, in mice
anyways, shown that about 100fibers are controlling
(18:43):
breathing.
Think of that.
Mice have 5,000 fibers, and 100of them are controlling
breathings.
So it gives you a sense.
If something as important asbreathing is controlled by these
fibers, and we know these fiberscontrol insulin release in the
pancreas, they controldigestion, they control how your
kidney works and your heartworks, then the opportunity to
(19:04):
go deep on the function of thosefibers and invent new therapies,
the opportunities are at hand.
Well, I'll tell you what.
If I was a young person today,I'd be getting into your field.
It's so exciting.
You're not the only one.
Right now, one of the fieldsthat we work in is called
neuroimmunity.
and in my opinion, and I feelpretty strongly about this, it's
the most exciting field ofscience and it is one of the
(19:25):
fastest growing fields today.
Young people do want to do this.
They do want to understand thisrelationship between the brain
and the immune system.
Look, we all know the studentsstudy for their exams and
they're fine and they get sleepdeprived and they work hard and
then they have the exam and theyget sick the next day.
We know that there's thisrelationship between the brain
(19:47):
and the immune system and we'veknown this for centuries, and
today we have the tools and theability to actually figure out
how it works at the molecularand neural level of the neural
fibers.
You know, if I was to ask you toproject out there, no promises,
but based on the science and theknowledge that you've seen so
(20:07):
far, what would be somethingthat you could anticipate in
tomorrow's world that would beexciting for our audience to
know about?
We are living in an era of aclear and present future.
Now look, I'm a scientist and aneurosurgeon and it's not my job
to predict the future, but ifyou know the area of a pond and
(20:28):
you know the doubling time of apond lily and you know how many
pond lilies are on the pondtoday because you can count
them, then you can predict withsome accuracy when the pond will
be covered with pond lilies.
Makes sense.
So with that sort of analysis,where we are today is we have
devices, computer chips, assmall as a multivitamin that you
can implant in people withrheumatoid arthritis,
(20:50):
inflammatory bowel disease, andother disabling and devastating
conditions, and put some ofthese people, not all, but some
of these people into completeremission so they don't have to
take medications or injectthemselves with
immunosuppressing drugs, andothers of these patients who
derive significant benefit,although they still need to take
medications.
That's today.
(21:12):
On the horizon, right around thecorner, will be clinical trials
for conditions like multiplesclerosis, lupus, probably
diabetes, metabolic syndrome,obesity, and maybe even
Alzheimer's disease, which areof course really important
conditions.
There are active researchprograms looking at how to
harness the information and thetherapeutic power of the nervous
(21:37):
system to treat cancer.
And there are clinical trialsbeing planned in the future.
So what do I see in the future?
I see a future where manydiseases that are currently
being treated with dangerous,powerful, expensive medications
will actually be treated withcomputer chips.
And I think that in the In theshort term, that is nearly
(21:58):
inevitable for some conditionslike rheumatoid arthritis.
And in the longer term, 10years, not 50 years, 10 years,
you're going to see patientswith these other conditions
benefiting from intervention,first of targeting the vagus
nerve, but later targeting othernerves.
This is, to me, this is not piein the sky.
This is very real.
(22:19):
That's exciting, first of all.
And thank you for sharing thatwith us.
I hope it can be as soon aspossible.
So let's talk about yourresearch and how it gets
converted, because I think it'stied to what you're saying.
So somebody is developing adevice right now to start to be
able to control inflammation.
Can you talk a little bit aboutthe device?
(22:42):
Sure.
And take me back to, was itfirst...
What's the first concept model?
Was it prototyped?
How many prototypes did youmake?
Where are we today with thisadvancement?
And what's it doing?
My laboratory in New York at theFeinstein Institutes made the
discovery that we could, in miceand rats, that we could use
(23:05):
electrodes on the vagus nerve tostop inflammation.
That was, as I said, in the late1990s.
We wrote the papers, publishedthem in Nature and other
journals, and we wrote patents.
Because, interestingly, at thattime in the 90s, the FDA in the
US and Europe had alreadyapproved the use of
(23:26):
pacemaker-like devices tostimulate the vagus nerve in the
left neck in patients withconditions such as epilepsy and
later depression, anxiety anddepression.
In both cases, epilepsy anddepression that was not
successfully being treated withmedications first.
Now, that was based, I won't gointo it, but that was based on
(23:48):
early work out of Italy,actually, post-World War II in
Pisa, Italy by a physiologistwho had noted, discovered that
when he elected electricallystimulated the vagus nerve.
In cats, it stopped seizures.
That's the longer story.
The shorter story is we knew inthe 1990s that you could safely
(24:10):
stimulate the vagus nerve with apacemaker device.
So I started a company with mycolleague, Shaw Warren.
We co-founded a company calledSetpoint Medical.
That was in 2007 to build thedevices and do the clinical
trials.
Because as you know, you can'tjust make something in your
garage and put it in a person.
There's a...
(24:31):
It's a complicated process.
It's a complicated process.
So we started the company to dothat.
So pure research to now makingthe devices.
Startup companies.
So we moved the charge intoSetpoint Medical, which is, as I
said, began in 2007.
They're now in Valencia,California.
(24:52):
And they spent years led firstby Mike Faltes, the chief
engineer, and Yakov Levine, whohad been a grad student in my
lab, who moved to the company.
And they worked for many, manyyears to build a device the size
of a fish oil pill or amultivitamin.
And that device has an ASIC, acomputer chip.
(25:14):
It has a rechargeable battery.
It has a lead, which contactsthe vagus nerve.
And it has an antenna to talk tothe doctor's tablet.
And it's encased in a silasticpee pod.
So the surgeon makes a smallincision in the neck, puts the
device onto the vagus nerve downby the carotid artery, wraps it
in the pee puts one stitchthrough this elastic, couple
(25:34):
stitches in the skin, patientgoes home the same day.
Two weeks later, patient comesback, to the doctor's office,
and the doctor logs in to thedevice on her tablet, turns it
on, and the therapy begins.
The therapy is one minute a dayof 400 microamps of pulses of
current.
Some of these patients haveslept through the treatment at
(25:56):
4.30 in the morning.
Others wake up.
I've met many of these patients,and I asked one in particular,
Dawn, if she wanted the...
I said, I'm sure the companycould change the time because it
wakes her up every morning, andshe goes, no.
She goes, She said, no, doc, Iwake up and I realize my hands
don't hurt and I smile and I'mglad to go to work.
(26:17):
Isn't that wonderful?
Let's be clear.
This technology, like anytechnology, is not a panacea.
It will not cure everybody.
It's not going to help 100% ofpeople.
But the results in about a thirdto a half of the patients are
dramatic and significant.
And the results in anotherquarter are still quite
statistically significant.
So it's amazing.
(26:37):
Meeting these patients, youasked about about my career and
the motivation.
Today, every time I meet apatient, it just makes me think
40 years of work is worth it.
Oh, definitely.
With those results, I'd takethose results Any day.
Any day.
Well, thank you for doing allthis work.
It is changing lives.
Well, I don't think you can...
(26:58):
Well, thank you for saying that,but the thanks really don't go
to me.
The thanks go to the hundreds ofcolleagues I've worked with, to
my lab co-head, Sangeeta Shivan,but to all the people that have
supported this work.
This has cost millions ofdollars over many, many years.
To the board members that havesupported the Feinstein
Institute.
And ultimately, who's taking therisk here, George?
(27:20):
The patients?
The patients.
I love what I do.
I get to work with brilliantpeople.
I have fun.
The patients, they have pain.
They're suffering.
And they come to us and we tellthem, we made this.
It might work.
We don't know.
We're not sure.
And they say, sign me up.
I mean, those are the peoplethat deserve tremendous credit.
(27:43):
They take the risk.
And we do it for them, but theytake the risk.
So they get credit.
That's very kind of you.
Helping the folks and thenpassing all the credit on to
your team.
That's the way leadership works.
So, Dr.
Tracy, thank you so much forcoming in today.
Thanks for having me on, George.
It's great to be here.
You bet.
Well, everybody, that's anotheredition of Tomorrow's World
(28:04):
Today.
We'll see you next time.
Bye now.
SPEAKER_00 (28:08):
Thank you for listening to this episode of
Tomorrow's World Today podcast.
Join us next time as we continueto explore the worlds of
inspiration, creation,innovation, and production.
Discover more atTomorrowsWorldToday.com, connect
with us on social media at TWTExplore, and find us wherever
podcasts are available.
Welcome to the Tomorrow's World Today podcast.
We sit down with experts, worldchanging innovators, creators
and makers to explore howthey're taking action to make
tomorrow's world a better placefor technology, science,
innovation, sustainability, thearts and more.
On this episode, host GeorgeDavison, who is also the host of
(00:21):
the TV series Tomorrow's WorldToday, sits down with Dr.
Kevin Tracy, a renownedneurosurgeon and the president
and CEO of the FeinsteinInstitutes for Medical Research.
Dr.
Tracy explores the critical roleof inflammation in the vagus
nerve in our health and unveilsa groundbreaking solution, a
tiny device designed to tackleinflammation at its core.
SPEAKER_01 (00:43):
Welcome everybody to another edition of Tomorrow's
World Today.
And today we have Dr.
Tracy.
He's a special guest of ours.
And I'd like to introduce him toall of you.
Dr.
Tracy, welcome.
Thank you for having me on.
It's great to be here.
Could you tell us a little bitabout the name of your company
and what you do?
It's so unique.
I'm the president of theFeinstein Institutes at
(01:04):
Northwell Health.
The Feinstein Institutes is theresearch home for the largest
healthcare system and privateemployer in New York.
I hear it's quite a bigoperation.
How many employees are wetalking?
Northwell employs about 110,000people now and provides care to
2 million patients a year.
Within the research enterpriseat the Feinstein Institutes, we
(01:26):
have about 100 laboratories withprofessors, faculty, and about
5,000 team members.
So it's a big operation.
And what's your role with allthis?
So as the president of theresearch arm, the Feinstein
Institutes, I also run mylaboratory with my colleague
Sangeeta Shivan, and we focus onwhat we call bioelectronic
(01:47):
medicine.
That's the area where we studyhow the nervous system, the
brain, controls the immunesystem, and we work on making
computer chips and nervestimulators to treat
inflammation.
Isn't that wonderful?
I mean, inflammation is a bigproblem.
I've learned a lot.
Well, first, I've seen it in ourfamily, and then I've had to
(02:07):
learn a lot more about it as Istarted to study up your
organization.
It's a bigger problem than manypeople realize.
If you look at the 60 millionpeople on planet Earth who die
every year, 40 million of themdie of conditions like heart
disease and stroke, diabetes,obesity, metabolic syndrome,
Alzheimer's disease,neurodegeneration, and even
(02:29):
cancer.
All of these conditions areeither caused by inflammation or
made worse by it.
And so the real question is ifinflammation is contributing to
two-thirds of the deaths onEarth every year, what if we
could treat inflammation?
What if we could stop itcompletely in its tracks?
What would that do to thoseother conditions?
(02:50):
And so those are the kinds ofquestions my colleagues and I
are studying now.
And could you walk us back intime a little?
I mean, you didn't start at thispoint in your career, you know,
and just arrive here.
Something must have got youstarted on this adventure.
Can you walk us back through howthis started to happen in your
life?
(03:10):
How far back do you want to go,George?
Well, it's like when you'reinnovating or you're inventing,
usually something impacts yourlife.
Maybe you saw something, youheard something, you made an
observational analysis, right,out of science, and something
moved you and has now taken youinto this career.
The specific events, twospecific events moved me into
(03:33):
the career path.
And one unexpected discovery inthe laboratory led to this major
path I'm on now.
So the two unexpected lifeevents were the death of my
mother when I was five of abrain tumor, which inspired me
to believe that I wanted tospend my life in neurosurgery
(03:53):
and in inventing things thatmight lead to therapies for when
I was young for other kids,mothers, and ultimately not for
other mothers, but for allothers.
Understood.
That's a hard thing to face as ayoung person.
But I'll tell you, you know,what a noble cause.
(04:15):
Well, you know, when you're myage now and have spent 40 years
pursuing something you love todo, it's interesting to look
back and connect the dots.
Whether there's cause andeffect, as you know, is always
up to debate.
But something, did cause mespecifically to become
interested in inflammation.
And that was another death of alittle girl this time when I was
(04:38):
training to be a neurosurgeonwho died in my arms of a
household accident, a burninjury.
And I was haunted by her deathbecause we couldn't explain why.
She had been recovering fromthis burn injury and suddenly
went into shock and died.
And we deduced it was from someunseen infection, but we
(04:58):
couldn't explain it.
And so, as I had alreadycommitted to a career in science
and neurosurgery, I hadn'tcommitted to a choice of what I
would study in the lab.
And when Janice died, I decidedI would try to study
inflammation and figure out whatled to her death.
So that was the second choice.
That was the second event.
But those were the two eventsthat pushed me onto the career
(05:22):
path.
The unexpected discovery thatled to what we hope now is a
revolutionary new therapy formillions of people, that
happened in the lab, you know,surreptitiously, accidentally,
unintended consequences.
And that was the day we wereputting...
an anti-inflammatory moleculeinto the brains of rats to study
(05:42):
how it would stop inflammationin the brain, which is what we
expected would happen and didhappen.
What we didn't expect is thatthe presence of these molecules
in the brain stoppedinflammation in the body of the
rat.
This was a total shocker and itwas inexplicable.
It took us at first months andsubsequently years to explain
(06:04):
what had happened, but what welearned is that that the brain
sends signals to the body tostop inflammation and based on
that, we've now been able toreduce this idea into a therapy
using a computer chip thatcontrols the nerves that control
the immune system to stopinflammation.
And we've now seen this hashelped successfully in a
(06:28):
clinical trial, patients withrheumatoid arthritis.
And we're, as you and I arespeaking, we're waiting on the
FDA's decision, which I fullyexpect will lead to the approval
for this idea in the UnitedStates as one of the treatments
for rheumatoid arthritis.
That's a great, great moment intime.
Thank you for your work.
For this audience, though, I'dlike to...
(06:48):
Let's...
Give them a little more clarity.
They may not be so familiar withinflammation.
And is there something that thebody naturally does that brings
inflammation on?
What is this moment, thistrigger that causes this?
Do you know?
We've known for centuries,dating back to the first
physician scientist, Galen, inancient Rome, who taught us that
(07:10):
inflammation is the body'sreaction to injury or infection.
So if you scratch yourself, evenif you do it with the tip of a
of a ballpoint pen, you'll seethe redness, the swelling, the
pain that occurs when youinjure, even gently injure the
skin.
And similarly with an infection.
You get an infected pimple, yousee the pain, you see the
(07:31):
swelling, the redness, the heat.
So that's what inflammation is.
Why do we have inflammation?
Because it is very importantdefensive mechanism to ward off
infection and to facilitate, toincrease the rate of healing of
an injury.
So the right amount ofinflammation in the right time
in the right place is verybeneficial.
(07:53):
And we know this because inconditions where people are
immunosuppressed and they don'thave enough inflammation, then
their bodies are susceptible todamaging injury and infection.
They can actually be very, veryserious.
So inflammation is a good thingto start.
But if it persists, if itdoesn't stop, if it ramps up, if
(08:15):
the inflammation becomes rampedup to a high level, now it can
actually damage normal organssuch as the kidneys such as the
lungs and even the heart andbrain and when that happens now
inflammation becomes the problemnot the beneficial solution so
this let's call it accidentaldiscovery You know, it's one of
(08:39):
those things.
There are a lot of inventionslike that.
Vulcanized rubber happened thatway.
Penicillin.
Penicillin happened that way.
I mean, but if you're not tryingand if you're not looking, you
know, then things can kind ofpass you by.
So was it lightning in a bottlethat you happened to discover
(09:01):
it, or is there a system thathas been set in the lab to make
sure everything is alwaysmonitored and seen and tested?
I think it's a little of theformer, but much more of the
latter.
I think there's lots of ways ofdoing invention and science, and
there's lots of ways of doingart and creativity, but they
come together around having agoal, a desire, a personal
(09:27):
philosophy to do something thatwould lead to, in the case we're
talking about now, lead to atherapy or a cure.
And so when something unexpectedhappens, rather than say, that's
not what I expected, throw thatexperiment away and do it over
again until you get what youexpect, every time something
unexpected happens is theopportunity to say, what if it's
(09:49):
true?
And what if there's analternative path to that goal
that I hadn't thought of beforeand maybe no one had thought of
before?
And then you have to imagine.
Remember Albert Einstein said,imagination is more powerful
than knowledge.
Now you have to imagine analternate route.
Instead of around the mountainor over the mountain, what if we
(10:10):
could go through the mountain?
And there's a lot teamed upagainst that approach.
There's a lot of pressure.
There's a lot of dogma.
There's a lot of history.
Well, this is how it is.
I don't know if it's a flash oflightning, but the flash of
insight comes when you say, oh,I can go through the mountain.
(10:32):
And if I went through themountain, that would solve this
problem.
That creates a new set ofchallenges.
How the heck are we going to gothrough the mountain?
And that's the next step.
But in the lab, the key is,having thought about going
through the mountain, the nextstep is, what is the experiment
I can do?
And it's usually only oneexperiment.
(10:54):
What's the experiment I candesign and do that if it works,
will convince not only me, buteverybody else, oh yeah, you can
go through the mountain.
And that's what we focus oureffort on next.
And in the case of thisexperiment, where we had this
accidental result wheresomething, a molecule in the
brain stopped inflammation inthe body, the experiment that
(11:14):
was told us we could go throughthe mountain was we put a an
electrode on the vagus nerve,which connects the brain to the
spleen and other organs.
And when we activated thatcircuit, like the brakes in your
car, it stopped inflammation.
So that was in the late 1990s,and that changed everything for
(11:36):
me and my colleagues, hundredsof colleagues who've now worked
on that in my lab and also atlaboratories around the world
ever since.
So the discovery of a...
So it's nature combined with youknow, man-made devices that
you're blending together toinvent something that hasn't
been created before to vibrate aspecific nerve in the body that
(12:00):
will then shut off theinflammation from manufacturing
more inflammation.
Exactly right.
Hundreds of millions of years ofevolution perfected a control
mechanism for the brain to stopinflammation at the right
amount.
Yes.
And that makes perfect sensebecause if you're evolving in
ancient animals, if you'reevolving over millions of years,
(12:23):
an immune system that has thecapacity to do tremendous
damage, then the pressure isalso on those organisms to
evolve a neural mechanism tocontrol it in a healthy way.
So absolutely evolution tookcare of inventing and producing
this hardwired neural circuitthat acts like the brakes on
your car to stop inflammation.
Silicon Valley and modernneuroscience and modern
(12:47):
understanding of molecularbiology gave us the tools to
connect the dots so we couldbuild a computer chip that would
target those fibers specificallyto activate them.
Activating the fibers stopsinflammation because like when
you activate the brakes in yourcar, it slows down your car.
What a great discovery.
(13:07):
It's very interesting now.
Even having worked on it for 25years, it gets more interesting
every day.
As a side note, in the field ofpain management, I had shoulder
surgery.
And after surgery, they want toget you moving.
Well, I couldn't get my armvery...
I couldn't get it above here.
(13:28):
And the therapist takes all thisice, he puts it on my shoulder,
right?
And within 10 minutes, he has myarm up over my head and and I
was observing him while he wasdoing this you know I'm like I
love science I'm watchingeverything he's doing wait he's
tapping the ice bag as he'smoving it right and I'm thinking
(13:48):
well this is kind of strange Icouldn't move my arm before but
he's just tapping an ice bag andI Apparently, the pain receptors
don't know how to deal withvibration and cold, which I just
found intriguing.
So I came back to Inventionland,and I sat down with the guys,
(14:08):
and I said, we're going to builda vibrating ice bag.
And so we built this thing,right?
And I went back for therapy, andI said, hey, Doc, look at what I
created here, you know?
And he put it on, and we usedit.
And he's like, this thing reallyworks.
And I said, yeah, isn't itgreat?
So I said, well, he's like, no,no, no, you're not taking this.
(14:28):
This is staying here.
It'll never leave here, George.
I said, I have the engineeringfiles.
We can make another one.
But it was just anotherobservation, discovery moment.
It's very different thaninflammation, but still pain
observing the body, tying ittogether with mechanical
devices.
It's not different thaninflammation.
(14:50):
Really?
Inflammation and pain gotogether.
All right.
Yeah, the question really is,What is pain?
And can you have pain in theabsence of inflammation?
And that's an incrediblyimportant question in
neuroscience and in immunologyright now.
If you recall the definitionfrom Galen 2,000 years ago after
injury or infection, it's pain,swelling, heat, and redness.
(15:14):
And when you have pain, injuryor infection, white blood cells
come in and they releasemolecules that create these
inflammatory responses.
Those molecules produce painbecause they interact with
neurons.
But here's the kicker.
Neurons also make thosemolecules.
So when someone asks me, what'sthe difference between the
(15:35):
nervous system and the immunesystem, I say, I'm not sure.
They're both capable of makingmemories.
They're both capable of causingpain.
Yes, I can see that.
When you say memories, you meanas in, like in my situation, it
would be muscle memory.
Is that what you mean?
Or memory of a specific virus orinfection that you get.
(15:55):
So when you get exposed to avirus or a bacteria, your immune
system comes in.
If it's never seen it before, itdeals with it.
You might be sick from theinflammation that's occurring
from the immune response to thevirus or the bacteria, but it
also makes what are calledmemory cells, and it makes
antibodies.
Now, the next time that you seethat virus or that bacteria,
(16:16):
your immune system immune systemmemory cells come to life very,
very quickly.
And you don't have the sameresponse.
In fact, sometimes you havealmost no response.
That's how vaccines work.
Vaccines produce memory cells.
So the immune system is capableof producing memory.
Your brain, obviously, iscapable of producing memory.
When it's injured frominflammation in the course of
(16:36):
Alzheimer's disease.
So it's, let me say it in, maybenot in the neuroscience way, but
it's saying, I've seen thisbefore and I know what to do so
I can move rapidly to solve aproblem rather than I haven't
seen this before and I'm not sosure how to solve it so it's
going to take me longer but I'llsolve it I thought you said you
weren't going to explain it inthe neuroscience way that is the
(16:59):
explanation really okay wellyou're explaining it well thank
you and I'm sure our audience isthankful too well I did write a
book about all this it's calledThe Great Nerve which is what
Galen called The Vegas Nerve andI think there's one more
important piece of explanationsince we're down to this level
of details So we call it thevagus nerve, but you actually
have two, like two thumbs andtwo kidneys.
(17:22):
And actually within each one ofthese two nerves, which runs
from about the level of your earthrough your neck down into all
the organs of your body, youactually have on each side
100,000 fibers.
So you said before that thesestimulators vibrate the neurons.
They actually do vibrate alittle bit, even when you
(17:42):
stimulate them with electricalinputs.
But we estimate of the 200,000fibers you have, 100 on each
side, we estimate that probablyaround 1,000 or 2,000 control
the immune system or theinflammatory response.
We call that the inflammatoryreflex.
So the obvious question is, whatare the other 198,000 fibers
(18:02):
doing?
So it's a very complicatedsystem, and we're
systematically, my colleaguesand I in labs around the world,
actually, are systematicallyworking through what each and
every one of those fibers does.
George, as an inventor, each andevery one of of those fibers or
groups of fibers, may be thesource of future inventions for
different conditions.
(18:23):
That makes sense.
I'm sure they're performing somefunction.
We know that they have specificorigins and insertions.
We know they have specificroots.
We know they carry specificmessages.
My colleague at Harvard, SteveLiberlis, has actually, in mice
anyways, shown that about 100fibers are controlling
(18:43):
breathing.
Think of that.
Mice have 5,000 fibers, and 100of them are controlling
breathings.
So it gives you a sense.
If something as important asbreathing is controlled by these
fibers, and we know these fiberscontrol insulin release in the
pancreas, they controldigestion, they control how your
kidney works and your heartworks, then the opportunity to
(19:04):
go deep on the function of thosefibers and invent new therapies,
the opportunities are at hand.
Well, I'll tell you what.
If I was a young person today,I'd be getting into your field.
It's so exciting.
You're not the only one.
Right now, one of the fieldsthat we work in is called
neuroimmunity.
and in my opinion, and I feelpretty strongly about this, it's
the most exciting field ofscience and it is one of the
(19:25):
fastest growing fields today.
Young people do want to do this.
They do want to understand thisrelationship between the brain
and the immune system.
Look, we all know the studentsstudy for their exams and
they're fine and they get sleepdeprived and they work hard and
then they have the exam and theyget sick the next day.
We know that there's thisrelationship between the brain
(19:47):
and the immune system and we'veknown this for centuries, and
today we have the tools and theability to actually figure out
how it works at the molecularand neural level of the neural
fibers.
You know, if I was to ask you toproject out there, no promises,
but based on the science and theknowledge that you've seen so
(20:07):
far, what would be somethingthat you could anticipate in
tomorrow's world that would beexciting for our audience to
know about?
We are living in an era of aclear and present future.
Now look, I'm a scientist and aneurosurgeon and it's not my job
to predict the future, but ifyou know the area of a pond and
(20:28):
you know the doubling time of apond lily and you know how many
pond lilies are on the pondtoday because you can count
them, then you can predict withsome accuracy when the pond will
be covered with pond lilies.
Makes sense.
So with that sort of analysis,where we are today is we have
devices, computer chips, assmall as a multivitamin that you
can implant in people withrheumatoid arthritis,
(20:50):
inflammatory bowel disease, andother disabling and devastating
conditions, and put some ofthese people, not all, but some
of these people into completeremission so they don't have to
take medications or injectthemselves with
immunosuppressing drugs, andothers of these patients who
derive significant benefit,although they still need to take
medications.
That's today.
(21:12):
On the horizon, right around thecorner, will be clinical trials
for conditions like multiplesclerosis, lupus, probably
diabetes, metabolic syndrome,obesity, and maybe even
Alzheimer's disease, which areof course really important
conditions.
There are active researchprograms looking at how to
harness the information and thetherapeutic power of the nervous
(21:37):
system to treat cancer.
And there are clinical trialsbeing planned in the future.
So what do I see in the future?
I see a future where manydiseases that are currently
being treated with dangerous,powerful, expensive medications
will actually be treated withcomputer chips.
And I think that in the In theshort term, that is nearly
(21:58):
inevitable for some conditionslike rheumatoid arthritis.
And in the longer term, 10years, not 50 years, 10 years,
you're going to see patientswith these other conditions
benefiting from intervention,first of targeting the vagus
nerve, but later targeting othernerves.
This is, to me, this is not piein the sky.
This is very real.
(22:19):
That's exciting, first of all.
And thank you for sharing thatwith us.
I hope it can be as soon aspossible.
So let's talk about yourresearch and how it gets
converted, because I think it'stied to what you're saying.
So somebody is developing adevice right now to start to be
able to control inflammation.
Can you talk a little bit aboutthe device?
(22:42):
Sure.
And take me back to, was itfirst...
What's the first concept model?
Was it prototyped?
How many prototypes did youmake?
Where are we today with thisadvancement?
And what's it doing?
My laboratory in New York at theFeinstein Institutes made the
discovery that we could, in miceand rats, that we could use
(23:05):
electrodes on the vagus nerve tostop inflammation.
That was, as I said, in the late1990s.
We wrote the papers, publishedthem in Nature and other
journals, and we wrote patents.
Because, interestingly, at thattime in the 90s, the FDA in the
US and Europe had alreadyapproved the use of
(23:26):
pacemaker-like devices tostimulate the vagus nerve in the
left neck in patients withconditions such as epilepsy and
later depression, anxiety anddepression.
In both cases, epilepsy anddepression that was not
successfully being treated withmedications first.
Now, that was based, I won't gointo it, but that was based on
(23:48):
early work out of Italy,actually, post-World War II in
Pisa, Italy by a physiologistwho had noted, discovered that
when he elected electricallystimulated the vagus nerve.
In cats, it stopped seizures.
That's the longer story.
The shorter story is we knew inthe 1990s that you could safely
(24:10):
stimulate the vagus nerve with apacemaker device.
So I started a company with mycolleague, Shaw Warren.
We co-founded a company calledSetpoint Medical.
That was in 2007 to build thedevices and do the clinical
trials.
Because as you know, you can'tjust make something in your
garage and put it in a person.
There's a...
(24:31):
It's a complicated process.
It's a complicated process.
So we started the company to dothat.
So pure research to now makingthe devices.
Startup companies.
So we moved the charge intoSetpoint Medical, which is, as I
said, began in 2007.
They're now in Valencia,California.
(24:52):
And they spent years led firstby Mike Faltes, the chief
engineer, and Yakov Levine, whohad been a grad student in my
lab, who moved to the company.
And they worked for many, manyyears to build a device the size
of a fish oil pill or amultivitamin.
And that device has an ASIC, acomputer chip.
(25:14):
It has a rechargeable battery.
It has a lead, which contactsthe vagus nerve.
And it has an antenna to talk tothe doctor's tablet.
And it's encased in a silasticpee pod.
So the surgeon makes a smallincision in the neck, puts the
device onto the vagus nerve downby the carotid artery, wraps it
in the pee puts one stitchthrough this elastic, couple
(25:34):
stitches in the skin, patientgoes home the same day.
Two weeks later, patient comesback, to the doctor's office,
and the doctor logs in to thedevice on her tablet, turns it
on, and the therapy begins.
The therapy is one minute a dayof 400 microamps of pulses of
current.
Some of these patients haveslept through the treatment at
(25:56):
4.30 in the morning.
Others wake up.
I've met many of these patients,and I asked one in particular,
Dawn, if she wanted the...
I said, I'm sure the companycould change the time because it
wakes her up every morning, andshe goes, no.
She goes, She said, no, doc, Iwake up and I realize my hands
don't hurt and I smile and I'mglad to go to work.
(26:17):
Isn't that wonderful?
Let's be clear.
This technology, like anytechnology, is not a panacea.
It will not cure everybody.
It's not going to help 100% ofpeople.
But the results in about a thirdto a half of the patients are
dramatic and significant.
And the results in anotherquarter are still quite
statistically significant.
So it's amazing.
(26:37):
Meeting these patients, youasked about about my career and
the motivation.
Today, every time I meet apatient, it just makes me think
40 years of work is worth it.
Oh, definitely.
With those results, I'd takethose results Any day.
Any day.
Well, thank you for doing allthis work.
It is changing lives.
Well, I don't think you can...
(26:58):
Well, thank you for saying that,but the thanks really don't go
to me.
The thanks go to the hundreds ofcolleagues I've worked with, to
my lab co-head, Sangeeta Shivan,but to all the people that have
supported this work.
This has cost millions ofdollars over many, many years.
To the board members that havesupported the Feinstein
Institute.
And ultimately, who's taking therisk here, George?
(27:20):
The patients?
The patients.
I love what I do.
I get to work with brilliantpeople.
I have fun.
The patients, they have pain.
They're suffering.
And they come to us and we tellthem, we made this.
It might work.
We don't know.
We're not sure.
And they say, sign me up.
I mean, those are the peoplethat deserve tremendous credit.
(27:43):
They take the risk.
And we do it for them, but theytake the risk.
So they get credit.
That's very kind of you.
Helping the folks and thenpassing all the credit on to
your team.
That's the way leadership works.
So, Dr.
Tracy, thank you so much forcoming in today.
Thanks for having me on, George.
It's great to be here.
You bet.
Well, everybody, that's anotheredition of Tomorrow's World
(28:04):
Today.
We'll see you next time.
Bye now.
SPEAKER_00 (28:08):
Thank you for listening to this episode of
Tomorrow's World Today podcast.
Join us next time as we continueto explore the worlds of
inspiration, creation,innovation, and production.
Discover more atTomorrowsWorldToday.com, connect
with us on social media at TWTExplore, and find us wherever
podcasts are available.
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