Electric Healing: Northwell Health’s Path to Bioelectronic Medicine

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. 🧬💡

Transcript

SPEAKER_00: 0:00

Welcome to the Tomorrow's World Today podcast. We sit down with experts, world changing innovators, creators and makers to explore how they're taking action to make tomorrow's world a better place for technology, science, innovation, sustainability, the arts and more. On this episode, host George Davison, who is also the host of the TV series Tomorrow's World Today, sits down with Dr. Kevin Tracy, a renowned neurosurgeon and the president and CEO of the Feinstein Institutes for Medical Research. Dr. Tracy explores the critical role of inflammation in the vagus nerve in our health and unveils a groundbreaking solution, a tiny device designed to tackle inflammation at its core.

SPEAKER_01: 0:43

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 to all of you. Dr. Tracy, welcome. Thank you for having me on. It's great to be here. Could you tell us a little bit about the name of your company and what you do? It's so unique. I'm the president of the Feinstein Institutes at Northwell Health. The Feinstein Institutes is the research home for the largest healthcare system and private employer in New York. I hear it's quite a big operation. How many employees are we talking? Northwell employs about 110,000 people now and provides care to 2 million patients a year. Within the research enterprise at the Feinstein Institutes, we have about 100 laboratories with professors, faculty, and about 5,000 team members. So it's a big operation. And what's your role with all this? So as the president of the research arm, the Feinstein Institutes, I also run my laboratory with my colleague Sangeeta Shivan, and we focus on what we call bioelectronic medicine. That's the area where we study how the nervous system, the brain, controls the immune system, and we work on making computer chips and nerve stimulators to treat inflammation. Isn't that wonderful? I mean, inflammation is a big problem. I've learned a lot. Well, first, I've seen it in our family, and then I've had to learn a lot more about it as I started to study up your organization. It's a bigger problem than many people realize. If you look at the 60 million people on planet Earth who die every year, 40 million of them die of conditions like heart disease and stroke, diabetes, obesity, metabolic syndrome, Alzheimer's disease, neurodegeneration, and even cancer. All of these conditions are either caused by inflammation or made worse by it. And so the real question is if inflammation is contributing to two-thirds of the deaths on Earth every year, what if we could treat inflammation? What if we could stop it completely in its tracks? What would that do to those other conditions? And so those are the kinds of questions my colleagues and I are studying now. And could you walk us back in time a little? I mean, you didn't start at this point in your career, you know, and just arrive here. Something must have got you started on this adventure. Can you walk us back through how this started to happen in your life? How far back do you want to go, George? Well, it's like when you're innovating or you're inventing, usually something impacts your life. Maybe you saw something, you heard something, you made an observational analysis, right, out of science, and something moved you and has now taken you into this career. The specific events, two specific events moved me into the career path. And one unexpected discovery in the laboratory led to this major path I'm on now. So the two unexpected life events were the death of my mother when I was five of a brain tumor, which inspired me to believe that I wanted to spend my life in neurosurgery and in inventing things that might lead to therapies for when I was young for other kids, mothers, and ultimately not for other mothers, but for all others. Understood. That's a hard thing to face as a young person. But I'll tell you, you know, what a noble cause. Well, you know, when you're my age now and have spent 40 years pursuing something you love to do, it's interesting to look back and connect the dots. Whether there's cause and effect, as you know, is always up to debate. But something, did cause me specifically to become interested in inflammation. And that was another death of a little girl this time when I was training to be a neurosurgeon who died in my arms of a household accident, a burn injury. And I was haunted by her death because we couldn't explain why. She had been recovering from this burn injury and suddenly went into shock and died. And we deduced it was from some unseen infection, but we couldn't explain it. And so, as I had already committed to a career in science and neurosurgery, I hadn't committed to a choice of what I would study in the lab. And when Janice died, I decided I would try to study inflammation and figure out what led to her death. So that was the second choice. That was the second event. But those were the two events that pushed me onto the career path. The unexpected discovery that led to what we hope now is a revolutionary new therapy for millions of people, that happened in the lab, you know, surreptitiously, accidentally, unintended consequences. And that was the day we were putting... an anti-inflammatory molecule into the brains of rats to study how it would stop inflammation in the brain, which is what we expected would happen and did happen. What we didn't expect is that the presence of these molecules in the brain stopped inflammation in the body of the rat. This was a total shocker and it was inexplicable. It took us at first months and subsequently years to explain what had happened, but what we learned is that that the brain sends signals to the body to stop inflammation and based on that, we've now been able to reduce this idea into a therapy using a computer chip that controls the nerves that control the immune system to stop inflammation. And we've now seen this has helped successfully in a clinical trial, patients with rheumatoid arthritis. And we're, as you and I are speaking, we're waiting on the FDA's decision, which I fully expect will lead to the approval for this idea in the United States as one of the treatments for rheumatoid arthritis. That's a great, great moment in time. Thank you for your work. For this audience, though, I'd like to... Let's... Give them a little more clarity. They may not be so familiar with inflammation. And is there something that the body naturally does that brings inflammation on? What is this moment, this trigger that causes this? Do you know? We've known for centuries, dating back to the first physician scientist, Galen, in ancient Rome, who taught us that inflammation is the body's reaction to injury or infection. So if you scratch yourself, even if you do it with the tip of a of a ballpoint pen, you'll see the redness, the swelling, the pain that occurs when you injure, even gently injure the skin. And similarly with an infection. You get an infected pimple, you see the pain, you see the swelling, the redness, the heat. So that's what inflammation is. Why do we have inflammation? Because it is very important defensive mechanism to ward off infection and to facilitate, to increase the rate of healing of an injury. So the right amount of inflammation in the right time in the right place is very beneficial. And we know this because in conditions where people are immunosuppressed and they don't have enough inflammation, then their bodies are susceptible to damaging injury and infection. They can actually be very, very serious. So inflammation is a good thing to start. But if it persists, if it doesn't stop, if it ramps up, if the inflammation becomes ramped up to a high level, now it can actually damage normal organs such as the kidneys such as the lungs and even the heart and brain and when that happens now inflammation becomes the problem not the beneficial solution so this let's call it accidental discovery You know, it's one of those things. There are a lot of inventions like that. Vulcanized rubber happened that way. Penicillin. Penicillin happened that way. I mean, but if you're not trying and if you're not looking, you know, then things can kind of pass you by. So was it lightning in a bottle that you happened to discover it, or is there a system that has been set in the lab to make sure everything is always monitored and seen and tested? I think it's a little of the former, but much more of the latter. I think there's lots of ways of doing invention and science, and there's lots of ways of doing art and creativity, but they come together around having a goal, a desire, a personal philosophy to do something that would lead to, in the case we're talking about now, lead to a therapy or a cure. And so when something unexpected happens, rather than say, that's not what I expected, throw that experiment away and do it over again until you get what you expect, every time something unexpected happens is the opportunity to say, what if it's true? And what if there's an alternative path to that goal that I hadn't thought of before and 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 an alternate route. Instead of around the mountain or over the mountain, what if we could go through the mountain? And there's a lot teamed up against 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 of lightning, but the flash of insight comes when you say, oh, I can go through the mountain. And if I went through the mountain, that would solve this problem. That creates a new set of challenges. How the heck are we going to go through the mountain? And that's the next step. But in the lab, the key is, having thought about going through the mountain, the next step is, what is the experiment I can do? And it's usually only one experiment. What's the experiment I can design and do that if it works, will convince not only me, but everybody else, oh yeah, you can go through the mountain. And that's what we focus our effort on next. And in the case of this experiment, where we had this accidental result where something, a molecule in the brain stopped inflammation in the body, the experiment that was told us we could go through the 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 that circuit, like the brakes in your car, it stopped inflammation. So that was in the late 1990s, and that changed everything for me and my colleagues, hundreds of colleagues who've now worked on that in my lab and also at laboratories around the world ever since. So the discovery of a... So it's nature combined with you know, man-made devices that you're blending together to invent something that hasn't been created before to vibrate a specific nerve in the body that will then shut off the inflammation from manufacturing more inflammation. Exactly right. Hundreds of millions of years of evolution perfected a control mechanism for the brain to stop inflammation at the right amount. Yes. And that makes perfect sense because if you're evolving in ancient animals, if you're evolving over millions of years, an immune system that has the capacity to do tremendous damage, then the pressure is also on those organisms to evolve a neural mechanism to control it in a healthy way. So absolutely evolution took care of inventing and producing this hardwired neural circuit that acts like the brakes on your car to stop inflammation. Silicon Valley and modern neuroscience and modern understanding of molecular biology gave us the tools to connect the dots so we could build a computer chip that would target those fibers specifically to activate them. Activating the fibers stops inflammation because like when you activate the brakes in your car, it slows down your car. What a great discovery. It's very interesting now. Even having worked on it for 25 years, it gets more interesting every day. As a side note, in the field of pain management, I had shoulder surgery. And after surgery, they want to get you moving. Well, I couldn't get my arm very... I couldn't get it above here. And the therapist takes all this ice, he puts it on my shoulder, right? And within 10 minutes, he has my arm up over my head and and I was observing him while he was doing this you know I'm like I love science I'm watching everything he's doing wait he's tapping the ice bag as he's moving it right and I'm thinking well this is kind of strange I couldn't move my arm before but he's just tapping an ice bag and I Apparently, the pain receptors don't know how to deal with vibration and cold, which I just found intriguing. So I came back to Inventionland, and I sat down with the guys, and I said, we're going to build a vibrating ice bag. And so we built this thing, right? And I went back for therapy, and I said, hey, Doc, look at what I created here, you know? And he put it on, and we used it. And he's like, this thing really works. And I said, yeah, isn't it great? So I said, well, he's like, no, no, no, you're not taking this. This is staying here. It'll never leave here, George. I said, I have the engineering files. We can make another one. But it was just another observation, discovery moment. It's very different than inflammation, but still pain observing the body, tying it together with mechanical devices. It's not different than inflammation. Really? Inflammation and pain go together. All right. Yeah, the question really is, What is pain? And can you have pain in the absence of inflammation? And that's an incredibly important question in neuroscience and in immunology right now. If you recall the definition from Galen 2,000 years ago after injury or infection, it's pain, swelling, heat, and redness. And when you have pain, injury or infection, white blood cells come in and they release molecules that create these inflammatory responses. Those molecules produce pain because they interact with neurons. But here's the kicker. Neurons also make those molecules. So when someone asks me, what's the difference between the nervous system and the immune system, I say, I'm not sure. They're both capable of making memories. They're both capable of causing pain. Yes, I can see that. When you say memories, you mean as in, like in my situation, it would be muscle memory. Is that what you mean? Or memory of a specific virus or infection that you get. So when you get exposed to a virus or a bacteria, your immune system comes in. If it's never seen it before, it deals with it. You might be sick from the inflammation that's occurring from the immune response to the virus or the bacteria, but it also makes what are called memory cells, and it makes antibodies. Now, the next time that you see that virus or that bacteria, your immune system immune system memory cells come to life very, very quickly. And you don't have the same response. In fact, sometimes you have almost no response. That's how vaccines work. Vaccines produce memory cells. So the immune system is capable of producing memory. Your brain, obviously, is capable of producing memory. When it's injured from inflammation in the course of Alzheimer's disease. So it's, let me say it in, maybe not in the neuroscience way, but it's saying, I've seen this before and I know what to do so I can move rapidly to solve a problem rather than I haven't seen this before and I'm not so sure how to solve it so it's going to take me longer but I'll solve it I thought you said you weren't going to explain it in the neuroscience way that is the explanation really okay well you're explaining it well thank you and I'm sure our audience is thankful too well I did write a book about all this it's called The Great Nerve which is what Galen called The Vegas Nerve and I think there's one more important piece of explanation since we're down to this level of details So we call it the vagus nerve, but you actually have two, like two thumbs and two kidneys. And actually within each one of these two nerves, which runs from about the level of your ear through your neck down into all the organs of your body, you actually have on each side 100,000 fibers. So you said before that these stimulators vibrate the neurons. They actually do vibrate a little bit, even when you stimulate them with electrical inputs. But we estimate of the 200,000 fibers you have, 100 on each side, we estimate that probably around 1,000 or 2,000 control the immune system or the inflammatory response. We call that the inflammatory reflex. So the obvious question is, what are the other 198,000 fibers doing? So it's a very complicated system, and we're systematically, my colleagues and I in labs around the world, actually, are systematically working through what each and every one of those fibers does. George, as an inventor, each and every one of of those fibers or groups of fibers, may be the source of future inventions for different conditions. That makes sense. I'm sure they're performing some function. We know that they have specific origins and insertions. We know they have specific roots. We know they carry specific messages. My colleague at Harvard, Steve Liberlis, has actually, in mice anyways, shown that about 100 fibers are controlling breathing. Think of that. Mice have 5,000 fibers, and 100 of them are controlling breathings. So it gives you a sense. If something as important as breathing is controlled by these fibers, and we know these fibers control insulin release in the pancreas, they control digestion, they control how your kidney works and your heart works, then the opportunity to go deep on the function of those fibers 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 fields that we work in is called neuroimmunity. and in my opinion, and I feel pretty strongly about this, it's the most exciting field of science and it is one of the fastest growing fields today. Young people do want to do this. They do want to understand this relationship between the brain and the immune system. Look, we all know the students study for their exams and they're fine and they get sleep deprived and they work hard and then they have the exam and they get sick the next day. We know that there's this relationship between the brain and the immune system and we've known this for centuries, and today we have the tools and the ability to actually figure out how it works at the molecular and neural level of the neural fibers. You know, if I was to ask you to project out there, no promises, but based on the science and the knowledge that you've seen so far, what would be something that you could anticipate in tomorrow's world that would be exciting for our audience to know about? We are living in an era of a clear and present future. Now look, I'm a scientist and a neurosurgeon and it's not my job to predict the future, but if you know the area of a pond and you know the doubling time of a pond lily and you know how many pond lilies are on the pond today because you can count them, then you can predict with some 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, as small as a multivitamin that you can implant in people with rheumatoid arthritis, inflammatory bowel disease, and other disabling and devastating conditions, and put some of these people, not all, but some of these people into complete remission so they don't have to take medications or inject themselves with immunosuppressing drugs, and others of these patients who derive significant benefit, although they still need to take medications. That's today. On the horizon, right around the corner, will be clinical trials for conditions like multiple sclerosis, lupus, probably diabetes, metabolic syndrome, obesity, and maybe even Alzheimer's disease, which are of course really important conditions. There are active research programs looking at how to harness the information and the therapeutic power of the nervous system to treat cancer. And there are clinical trials being planned in the future. So what do I see in the future? I see a future where many diseases that are currently being treated with dangerous, powerful, expensive medications will actually be treated with computer chips. And I think that in the In the short term, that is nearly inevitable for some conditions like rheumatoid arthritis. And in the longer term, 10 years, not 50 years, 10 years, you're going to see patients with these other conditions benefiting from intervention, first of targeting the vagus nerve, but later targeting other nerves. This is, to me, this is not pie in the sky. This is very real. That's exciting, first of all. And thank you for sharing that with us. I hope it can be as soon as possible. So let's talk about your research and how it gets converted, because I think it's tied to what you're saying. So somebody is developing a device right now to start to be able to control inflammation. Can you talk a little bit about the device? Sure. And take me back to, was it first... What's the first concept model? Was it prototyped? How many prototypes did you make? Where are we today with this advancement? And what's it doing? My laboratory in New York at the Feinstein Institutes made the discovery that we could, in mice and rats, that we could use electrodes on the vagus nerve to stop inflammation. That was, as I said, in the late 1990s. We wrote the papers, published them in Nature and other journals, and we wrote patents. Because, interestingly, at that time in the 90s, the FDA in the US and Europe had already approved the use of pacemaker-like devices to stimulate the vagus nerve in the left neck in patients with conditions such as epilepsy and later depression, anxiety and depression. In both cases, epilepsy and depression that was not successfully being treated with medications first. Now, that was based, I won't go into it, but that was based on early work out of Italy, actually, post-World War II in Pisa, Italy by a physiologist who had noted, discovered that when he elected electrically stimulated the vagus nerve. In cats, it stopped seizures. That's the longer story. The shorter story is we knew in the 1990s that you could safely stimulate the vagus nerve with a pacemaker device. So I started a company with my colleague, Shaw Warren. We co-founded a company called Setpoint Medical. That was in 2007 to build the devices and do the clinical trials. Because as you know, you can't just make something in your garage and put it in a person. There's a... It's a complicated process. It's a complicated process. So we started the company to do that. So pure research to now making the devices. Startup companies. So we moved the charge into Setpoint Medical, which is, as I said, began in 2007. They're now in Valencia, California. And they spent years led first by Mike Faltes, the chief engineer, and Yakov Levine, who had been a grad student in my lab, who moved to the company. And they worked for many, many years to build a device the size of a fish oil pill or a multivitamin. And that device has an ASIC, a computer chip. It has a rechargeable battery. It has a lead, which contacts the vagus nerve. And it has an antenna to talk to the doctor's tablet. And it's encased in a silastic pee pod. So the surgeon makes a small incision in the neck, puts the device onto the vagus nerve down by the carotid artery, wraps it in the pee puts one stitch through this elastic, couple stitches in the skin, patient goes home the same day. Two weeks later, patient comes back, to the doctor's office, and the doctor logs in to the device on her tablet, turns it on, and the therapy begins. The therapy is one minute a day of 400 microamps of pulses of current. Some of these patients have slept through the treatment at 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 company could change the time because it wakes her up every morning, and she goes, no. She goes, She said, no, doc, I wake up and I realize my hands don't hurt and I smile and I'm glad to go to work. Isn't that wonderful? Let's be clear. This technology, like any technology, is not a panacea. It will not cure everybody. It's not going to help 100% of people. But the results in about a third to a half of the patients are dramatic and significant. And the results in another quarter are still quite statistically significant. So it's amazing. Meeting these patients, you asked about about my career and the motivation. Today, every time I meet a patient, it just makes me think 40 years of work is worth it. Oh, definitely. With those results, I'd take those results Any day. Any day. Well, thank you for doing all this work. It is changing lives. Well, I don't think you can... Well, thank you for saying that, but the thanks really don't go to me. The thanks go to the hundreds of colleagues 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 of dollars over many, many years. To the board members that have supported the Feinstein Institute. And ultimately, who's taking the risk here, George? The patients? The patients. I love what I do. I get to work with brilliant people. I have fun. The patients, they have pain. They're suffering. And they come to us and we tell them, 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 people that deserve tremendous credit. They take the risk. And we do it for them, but they take the risk. So they get credit. That's very kind of you. Helping the folks and then passing all the credit on to your team. That's the way leadership works. So, Dr. Tracy, thank you so much for coming in today. Thanks for having me on, George. It's great to be here. You bet. Well, everybody, that's another edition of Tomorrow's World Today. We'll see you next time. Bye now.

SPEAKER_00: 28:08

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