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  • Kelly Owens

Revolutionary Research and the Autonomy of Patients

What does it say about the health of our nation when every other commercial on TV is for an immune-suppressing biologic? Each commercial follows the same format: a thirty-second ad where a silent person begins the commercial in some kind of pain and then they are introduced to a great new drug. The person is given their prescription and as they walk out into the sunshine and through a randomly placed farmer’s market, the narrator of the commercial spends twenty of the thirty allotted seconds going through a laundry list of side effects, while the person happily examines a head of lettuce and exchanges pleasantries with the townspeople. The main character makes his or her way through the entire farmer’s market and is now throwing a Frisbee to a stranger’s dog in the park as the narrator continues listing side effect after side effect. Our main character is quite literally running out of things to do as the narrator’s list of side effects and black box warnings barrels on.

For those of us who have actually experienced being chronically ill, we know that the picture painted in the commercial is rosy compared to what we’ve experienced – but that’s the point, isn’t it? To sell the drug – to sell the promise of the drug.

The reality, however, isn’t reflective of the ad space.

Recently, Creaky Joints published a study showing that 74% of patients with rheumatoid arthritis are unhappy with their current treatment options, and that pain, fatigue, and insomnia continue to cripple their quality of life. Further, in 2013, the U.S. economy spent 304 billion dollars on arthritis alone, and RA patients lost 252 million in wages due to their disease. Arthritis is the leading cause of work disability in the United States, and patients with rheumatoid arthritis have a 10-15 year shorter life expectancy than their healthy counterparts, due to inflammation attacking their cardiovascular system, often leading to heart disease.

Patients with Crohn’s disease have an increased risk of developing colon cancer. We’re just scratching the surface of autoimmune diseases: I haven’t touched upon those suffering from lupus, ankylosing spondylitis, multiple sclerosis, scleroderma, and more – all of which are diseases resulting from the overproduction of inflammation.

In clinical trials, biologics like those you see in the commercials (Humira, Enbrel, Remicade, and more) the FDA only requires that fifty percent of the trial population have a twenty percent reduction in disease symptoms in order to be considered effective enough for FDA approval.

It sure doesn’t sound a whole lot like current treatment options are working for patients.

Imagine a world where patients aren’t dependent on expensive pharmaceuticals that drive up insurance premiums, and where their diseases aren’t just hardly managed, but treated to the point where they can thrive.


I was diagnosed with Crohn’s disease and inflammatory arthritis in 2002. In the 15 years that followed, I was prescribed twenty-two different biologics and immunosuppressants, all of which failed, leaving me battling active disease from the time I was thirteen until I was twenty-eight.


I learned about vagus nerve stimulation in 2014 after seeing Dr. Tracey’s interview with the Huffington Post about this tiny device that uses electrons to treat inflammatory diseases. At the time, he shared that it was going to be tested in rheumatoid arthritis. I knew immediately that it would help me too — it seemed to me that while drugs negotiated with the body, vagus nerve stimulation seemed to command it. However, a trial didn’t become available for Crohn’s until 2017. By then, my health had further deteriorated. When we learned that the trial was taking place in the Netherlands, my husband and I sold everything and spent six months abroad. Within days, my pain decreased significantly and within weeks, my joint swelling did as well. Two months later I was deemed in clinical remission for the first time since my diagnosis, nearly sixteen years prior.

It's been three years since my surgery and life looks nothing like it did before. I am living proof of what chronically ill patients are capable of accomplishing when their lives are no longer plagued by disease. Prior to vagus nerve stimulation, I had to think about what movements it would take to button a shirt, brush my hair, or wash a dish. Nowadays, I exercise daily and live a life free of arthritis. As the years pass, it’s difficult to imagine where I’d be without this revolutionary field of medicine.


Dr. Kevin J. Tracey, the CEO of the Feinstein Institutes for Medical Research, is the founder of this field of medicine. In 2002, his paper published in Nature titled ‘The Inflammatory Reflex’ was the first-ever to show that electrical stimulation of the vagus nerve reduces inflammatory cytokines in the immune system. Realizing that there wasn’t a platform for conducting clinical trials using neuromodulating devices, he founded SetPoint Medical, a device company that set the stage for bioelectronic medicine clinical trials.

To date, clinical trials have been overwhelmingly positive. Bioelectronic medicine clinical trials have shown that more than 60% of the trial population either go into remission or have up to an 80% reduction in symptoms, with their disease activity scores decreasing by more than 100 points. Trials include not only implantable devices as have been successful with SetPoint’s trials but also transcutaneous devices that stimulate the vagus nerve auricularly, through the cymba concha cartilage of the ear. In trials conducted by researchers at the Feinstein Institute, patients with rheumatoid arthritis stimulating their vagus nerve auricularly saw their TNF level (an inflammatory cytokine) drop by 80% for twenty-four hours.

Over the last three years, I have spoken to over a thousand patients about bioelectronic medicine and have built a database of patients who are eagerly awaiting access to this therapy. I’ve built relationships with patients across a spectrum of diseases from Crohn’s, arthritis, MS, and more. They reach out regularly asking when a trial will be available for them or how they can pursue ‘Right to Try’ or ‘Compassionate Use.’ Both of those pieces of legislation have great intentions, but they don’t actually work in real life. People are desperate. Current treatment options available are failing them, and they deserve so much more. Patients are suffering and some are dying waiting for their right to have a new treatment option, while those who make safety decisions on their behalf are shielded from the burden of knowing this truth: the truth that time isn’t on our side, and that red tape hurts more people than it helps.

The hurdles we face in broader deployment of translating this research from bench to bedside are philosophical, financial, and bureaucratic. From a philosophical standpoint, we are asking the medical community to think about disease in an entirely new way. Until now, the medical community has been broken down into specialties that view the body through different organs, systems, and functions, and not as a whole – until now, the central nervous system and immune system weren’t though to interact with each other. Now, we know that they interact intimately, communicating constantly and altering the other’s responses based on infection and injury, and neural mechanisms that either function as they should, or don’t – which then allows inflammation to run rampant. Rather than treating patients like they can be broken down into parts – between gastroenterology, rheumatology, cardiology, neurology, and the like – we need to look at the patient’s pathology as a system that works in conjunction with all of those parts. That is going to require changing the hearts and minds of those who have been practicing medicine for decades and have learned about the body differently than we understand it today.

Financially, we need to allocate funding to expand clinical trials to a broader patient population. It’s not enough to do the research if we simply sit with the knowledge we have, rather than allowing millions of patients to benefit from it. To know is a privilege, but to directly benefit from this research is currently a luxury – and should be a right to all patients who are still suffering, which brings me to the bureaucratic hurdle: in the land of the free, I struggle to grasp how regulations and policies make medical decisions for patients who should have the autonomy to decide for themselves what risks they are willing to take in exchange for the possibility of the health I now hold so dearly.


Vagus nerve stimulation has been proven safe for the last 20 years in over 100,000 people with epilepsy and depression. Yet how many years have to pass before the FDA decides that it's safe for those with inflammatory diseases? How many people have to fail at biologics and DMARDs, both of which come with black-box warnings and side effects sometimes worse than the disease itself? How many people with inflammatory diseases have to end up dying from sepsis and cardiovascular issues, all of which are related to the overproduction of inflammation?

We have more work to do moving forward, and I eagerly await the day when there are more voices speaking to their experiences and sharing their stories about how this revolutionary field of medicine transformed their lives as much as it has mine.

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