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  • Kelly Owens

When Good Intentions Become Red Tape

As I watched President Biden’s recent address to Congress, I heard a familiar theme weaved throughout: the spirit of our American Exceptionalism. We are, indeed, the home of invention and innovation. Over the last fifty years, our commitment to science has taken us to the moon and Mars, given us the Internet, and has delivered vaccines in record time to combat COVID-19.


The common thread among all of these breakthroughs is investments in science – yes – but it is also a testament to what can happen when we cut red tape that stagnates progress.

In his address, President Biden outlined a noble idea; a new federal agency modeled after the Department of Defense’s DARPA called the Health Advanced Research Projects Agency

(HARPA). HARPA’s mission will be to fund research that creates new methods of disease prevention, detection, and treatment.


I am heartened to see our country becoming one that once again seeks, invests, and values discovery. While we certainly need to keep accelerating discovery in all fields of medical research to uncover the mechanisms of cancer, Alzheimer’s, diabetes, and more, what is of equal necessity is cutting the red tape that prevents current research from moving from bench to bedside.


I should know. After suffering from Crohn’s disease and inflammatory arthritis for fifteen years and failing two dozen biologics and immunosuppressants, my husband and I sold everything we owned to move to Amsterdam for six months so I could participate in a clinical trial using vagus nerve stimulation, part of an emerging field called bioelectronic medicine. Two months after being implanted with a device in June of 2017, I was deemed in clinical remission for the first time since my diagnosis fifteen years prior.


Bioelectronic medicine is the convergence of neuroscience, molecular medicine, and bioengineering that uses devices to stimulate nerves to achieve a targeted outcome in the immune system, bringing the body into a state of homeostasis rather than immunosuppression. Importantly, it is without side effects, whereas current FDA-approved biologics and immunosuppressants often come with susceptibility to infections, rare cancers, and have black box warnings.


It was a long road to get to bioelectronic medicine. I learned about it in 2014 when I saw an interview with the founder of this field of medicine, Dr. Kevin Tracey, talking about using devices to treat disease. It made sense to me; it seemed to me that whereas medicine negotiated with the body, bioelectronic medicine seemed to command it.


In 2015, Dr. Tracey penned an op-ed in the Wall Street Journal: Let Patients Decide How Much Risk They’ll Take. There, he discussed how Institutional Review Boards and human-research subject protocols weed out the bad-actors and only allow for ethical, peer-reviewed research, and current FDA regulations hinder translation to patients. I read that article back then, prior to my vagus nerve implant, and I nodded my head: it seemed to me that this was a matter of my body, my choices, my liberty (don’t we have a statue about that in New York Harbor?).


As patients, do we not have the right to live? To thrive? The freedom of action to have autonomy over our body and well-being without the interference and injuries of government bureaucracy?


Since Dr. Tracey published The Inflammatory Reflex in Nature in 2002, billions of dollars have poured into the space of bioelectronic medicine from agencies like DARPA as well as private industry. Still, billions of dollars are not enough to translate a revolutionary therapy from bench to bedside in the last twenty years. Continued investments are necessary, but what is of parallel need is cutting red tape that stagnates translation. Phase III trials for rheumatoid arthritis have received Breakthrough Device Designation, meaning that vagus nerve stimulation has proven more effective than the current therapies that are FDA approved – and upon trial completion in 2023, it will be expedited for FDA approval for rheumatoid arthritis.


But what about the vast array of patients with inflammatory diseases who will continue to suffer? What about those with Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and more? Well, more red tape and more money: more trials will be needed to prove efficacy in those diseases even though we already have more than enough evidence of the neural mechanism that turns off the overproduction of inflammation in the spleen. While more research is needed to target these therapies even more effectively, vagus nerve stimulation has demonstrated safety and overwhelmingly positive efficacy.


Not to mention that vagus nerve stimulation has been FDA approved for twenty years for epilepsy and drug-refractory depression, with 100,000 patients treated with this therapy over the last two decades. One in five prescriptions written today is for off-label use, meaning that physicians are prescribing FDA-approved drugs for their patients to treat conditions different than what the drug is approved for.


Over the last three years, I have heard from thousands of patients who are eagerly awaiting access to this therapy. In instances where clinical trials are not available, patients inquire if they can qualify through Compassionate Use and Right to Try. Unfortunately, those laws are largely pat-yourself-on-the-back legislation. All it really means is Right to Ask.


Why is this emerging field of medicine so necessary? Because current treatment options aren’t nearly effective enough. The fact of the matter is that in clinical trials, drugs like Remicade, Humira, Enbrel, and other biologics only need 50% of the trial population to have a 20% reduction in symptoms in order for the FDA to consider these drugs ‘effective.’ On the contrary, 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.


Recently, alongside fellow ALS patients, Corey Polen worked with Senator Braun to create the Promising Pathways Act. This bill would expand access to investigational therapies for patients with serious and life-threatening illness by requiring the FDA to provide provisional approvals for therapies that “demonstrate substantial evidence of safety and relevant early evidence of positive therapeutic outcomes.” This bill needs support in the Senate and the House and has a long way to go to get that support. Like the AIDs community did thirty years ago, the ALS community has the grit to get this done because they simply have no choice; their lives depend on this. ALS progresses at such a rate that time is quite literally of the essence. While the purpose of the FDA is noble, bureaucracy is killing more ALS patients than it is protecting.


What Congress needs to do is pass the Promising Pathways Act. The FDA should be required to create pathways like the PPA for serious, life-threatening illness — as they’ve done before — and they should add PPA provisions onto Breakthrough Device Designation for patients with inflammatory diseases as well.


Over the last year, America has shown what it can do when we invest in research and cut red tape. Let this be the start of a new era of American Exceptionalism when science and progress impact lives today. The patients who I speak to every day are desperate and out of options. Once upon a time, I was, too. Nearly four years later, as I write these words today, that young disabled woman I once was is only a memory.


Let’s make that possible for more.


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