Shaping the New Field of Bioelectronic Medicine

A bioelectronic device.
A bioelectronic stimulator. A recent clinical trial of the device had very promising initial results.

Kevin Tracey, MD, president and CEO of the Feinstein Institute for Medical Research, is an expert in the fields of medical innovation and bioelectronic medicine. In our latest Leadership Series interview, Dr. Tracey discusses a novel approach to replace traditional drug therapies: Bioelectronic medicine, which can treat a range of diseases, including rheumatoid arthritis and inflammatory bowel disease.

Question from interviewer: Bioelectronic medicine. What is it? What does it do? Why should I care?

Dr. Tracey: Bioelectronic medicine is the concept that makes it possible to design devices, specific computer chips, which interact with nerves in the patient's body to replace drugs.

It is a way to use electrical signals through computer chip-like devices and nerve stimulating electrodes that essentially replace drugs, such as Remicade and Enbrel, which people currently use to treat rheumatoid arthritis and inflammatory bowel disease.

This is the place where our current knowledge in molecular medicine, neurophysiology and biomedical engineering come together.

It’s a brand new field. The idea of harnessing the electrical information that nerves normally use to communicate and to harness that electrical information to deliver therapy to patients with a range of diseases is based on relatively recent discoveries of how it's possible to actually do that.

What my colleagues and I have shown is, we can regulate the activity of signals in one of the major nerves of the body called the vagus nerve, which travels to the spleen, an important organ in the immune system. These electrical signals that travel in the vagus nerve to the spleen control the amount of inflammation that develops in diseases, such as rheumatoid arthritis and inflammatory bowel disease.

Q: Without breaking any patient-doctor confidences, can you give me some real life examples of where bioelectronic medicine made the difference in a patient’s treatment and life?

Dr. Tracey: There is a patient from a SetPoint Medical clinical trial that we can discuss. This was the first clinical trial to treat rheumatoid arthritis [RA] using an implanted nerve stimulator. The 38-year-old patient, Mirela Mustacevic, had been diagnosed when she was 22 and had tried nine medications to treat her RA. She received the implant in April 2013 and since then has gone from barely being able to hold a pencil to dressing herself without help, taking long walks and even riding her bicycle for 20-mile trips in her home town. The New York Times Magazine featured the story on the cover.

Q: Is this going to lead to a bionic person? Will you be planting a chip somewhere in the body to generate those electronic signals?

Dr. Tracey: Currently it’s possible to use pacemaker-like devices, which are implanted surgically, and then connected to the vagus nerve or other nerves of the body using electric lead wires. In the future, we envision very small devices the size of the tip of your little finger that will be implanted directly onto the nerve and these devices will replace the entire pacemaker.

These devices will have a computer chip, a battery, an electrode, and these will be fully programmable. The doctor will be able to communicate with these devices through an iPad or a laptop. The treatment that the patient will receive will go from the computer to the device to the nerve.

Bioelectronic Medicine Is Happening Now

Q: When will this become a viable treatment?

Dr. Tracey: This is not some futuristic idea. It is happening today.

We have the basic molecular understanding of the mechanisms and approaches that we have developed and discovered over the last 18 years. We have seen early clinical trial results that hold tremendous promise.

The next step in the development of these devices to be broadly used are additional clinical trials, FDA and other regulatory approval and adoption into a new world where people will think of using devices instead of drugs.

What we’re really talking about here is the opportunity for devices to be used in some patients instead of drugs. This is the first potential real challenge to a new way of thinking about treatment that’s come along in medicine in a long, long time.

In addition, there is treatment for some patients for which there are no drugs today.

So, there’re two tremendous opportunities here to provide new therapies for previously or currently untreatable diseases and to provide therapies that will be more effective, cheaper, or safer than currently available drugs.

Q: Will these devices replace drug therapies?

Dr. Tracey: I don’t envision devices will replace the entire drug industry.

The drug industry is in the business of developing therapies and so investments by the drug industry into this space are likely to happen. I do, however, believe that some of today’s drugs which are either minimally or not that effective, very expensive and/or toxic may be replaced in the future by bioelectronic devices.

Q: What pushback are you getting?

Dr. Tracey: There is always pushback from new ideas in any field. But particularly in medicine which, by its conservative nature, must move slowly and carefully so that people don’t get hurt.

The pushback in bioelectronic medicine has not been significantly different than the pushback I’ve experienced in 30 years of research of seeing other drugs and therapies come to market. The pushback comes from a misalignment of incentives.

Patients want all their treatments for free. Doctors and inventors want things done quickly. Venture capitalists and early investors want their money in and out quickly. And the FDA and those with the longer-term vision want safety and efficacy to be proven slowly and carefully.

To align those incentives in any area, today looking back 15 years when we started doing this or looking forward 15 years that’s always going to be difficult. But at the end of the day the ideas that are correct, the ideas that work, the ideas that are true, they get delivered to the patients because we have an increasingly intelligent patient population in the world, and they demand things that work.

Great Ideas Attract Great People

Q: Let’s talk about the Feinstein Institute for Medical Research. How was it created and why it is important?

Dr. Tracey: The Feinstein Institute is the home to 55 laboratories as the research center for the North Shore-LIJ Health System.

It was founded approximately 15 years ago around the work of key laboratory leadership -- many of whom were present in the health system at that time. Currently, the Feinstein Institute is a collaborative team of scientists that work together on really hard problems in medicine.

Q: What specific programs are underway and how might they impact our lives in the coming years?

Dr. Tracey: The Feinstein Institute has research programs spanning a number of fields in medicine. Primarily in the fields of neuroscience and behavioral health and in the field of inflammation and immunology. Those two broad research fields account for approximately 90% of the research here.

Those fields include some of the major diseases that challenge the globe today, including Alzheimer’s disease, schizophrenia, inflammatory bowel disease, rheumatoid arthritis, lymphoma, lupus, Parkinson's disease, diabetes and the list goes on. These diseases are important to the future health of our population. Not only in the New York region, but also around the world.

Q: What are you doing to attract knowledgeable people to this process? How are you encouraging them that this is going to be among the leading levels of medicine in the coming years?

Dr. Tracey: Great ideas attract great people. We have been in the processes of developing this idea for 15 years, of investing and expanding our footprint, our space in bioelectronic medicine. In the past year or so, we’ve undergone significant outreach and inquiry with leaders in the field of either molecular medicine, neurophysiology, or bioelectronic or biomedical device development and biomedical engineering.

We’ve been speaking to biomedical engineers, neurophysiologists, and experts in molecular medicine and collecting information needed to understand exactly how to recruit people to this newly emerging field. People want to work in this space. People want to come and do this. We’re quite confident that we will be able to attract the best and the brightest into this space to launch this area of bioelectronic medicine here in New York.

Q: You’ve probably created an enormous number of startup companies that have been thrown-off by this new process. Talk about how these start-up companies are accelerating this process in the private arena.

Dr. Tracey: Today, inventions made in academic laboratories, university departments and research institutes like the Feinstein Institute with an eye towards moving these ideas and inventions to the clinic have to embrace the for-profit sector. Ideas are plentiful and the hard work of converting an idea into an invention is expensive and difficult. But neither the idea, nor the invention is sufficient to have a cure.

In order to have drugs or therapies to cure disease, there is a transition period from the idea and the invention of the product. And the product, whether it’s a pill or a bioelectronic device requires a development phase which is also risky, expensive and time consuming. Our solution here at North Shore-LIJ and at The Feinstein Institute has been to embrace the for-profit component of the development pathway in order to fulfill our not-for-profit mission. It’s going to require huge investments of time and money to cross that bridge from the invention stage, to the clinical development stage, to the product, and ultimately to marketing. If one doesn’t embrace that entire spectrum, than the ideas stay stuck in the lab.

That’s not our mission. The mission of researchers here at The Feinstein Institute is to produce knowledge to cure disease. That mission can’t be realized, unless we engage the entire spectrum. We have a number of mechanisms of engaging the for-profit side of the development trajectory to convert our discoveries into products.

At the end of the day what matters is the not-for-profit mission, which is to produce knowledge to cure disease. And as the knowledge progresses to the development of a clinical product, we feel responsible and enjoy being part of the trajectory until we realize our goal of a cure delivered to our patients.

Formative Experiences

Q: Tell me some of the personal reasons you decided to become a neurosurgeon?

Dr. Tracey: When I was five years old, my mother died suddenly of a brain tumor. Her father was a pediatrician, a professor of pediatrics at Yale. I asked him, “Why didn’t the surgeon take the tumor out?” He explained that the tumor was intertwined between the nerves of the brain and that to remove the tumor would have damaged the nerves. I learned at that age that nerves are responsible for everything that makes us human -- how we move, how we think, how we talk, and I became interested in this problem of diseases of the brain and of nerves from a very young age.

Q: Did some patients along the way encourage, or have any impact on your care as to where it would go?

Dr. Tracey: When I was a neurosurgery resident at New York Hospital, I came across a young patient named Janice. Janice had crawled across the kitchen floor while her mother was cooking spaghetti and crawled between her mother's legs, causing her to trip and spill boiling water on her.

Janice subsequently died in my arms. I had to answer questions of Janice’s parents as to why she died and what she died of. One of the questions that I couldn’t answer was why did Janice go into shock? Why did her blood pressure fall? Since then, I’ve struggled with understanding the answer to that question because I couldn’t provide it to that family.

My colleagues and I subsequently discovered one of the molecules that caused that problem, the shock that Janice had, was a molecule that is now a drug target for rheumatoid arthritis, inflammatory bowel disease, and other inflammatory diseases. It’s called TNF and the drugs are called Remicade, Enbrel and go under other names as well.

These drugs are now taken by six million patients and account for $50 billion worth of annual sales around the world.

I’ve had the privilege in a relatively short 30-year career of seeing ideas go from unknown questions to molecular answers that can be studied and identified in a laboratory to drugs that can help people and change their lives.

Q: If you were talking to a group of young people today in medicine, what specific advice would you give them in terms of their medical career?

Dr. Tracey: Follow your dreams. Find out what it is you love to do because medicine is a wide-open field. You can be a brilliant bedside practitioner and clinician. You can be a brilliant author. You can be a brilliant teacher or a businessperson. You can be an inventor and a scientist. The challenge today in medicine is it’s changing so fast that you need to set the correct career trajectory when you’re young.

It comes back to the advice that grandma often gives -- find out what you want to do in your heart and find a way to do it. In medicine, the opportunity to do that is very rich and very promising. It’s a great time to go into medicine.

Q: When you walk out of here at night what excites you?

Dr. Tracey: I like to go home and see my kids as they grow up into a world that’s changing very rapidly. And I see the opportunities available to them.

Many of these opportunities are in education. Many of these opportunities are in medicine and in science; and many of these opportunities are in building things that we can’t even imagine today could be built.

It comes from making things out of materials that are available, but that people have not imagined could be put together in that way before.

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