‘Right To Try Laws’ and Legal Access to Psilocybin Therapy with Dr. Jonathan Fields

Dr. Jonathan Field brings a wealth of functional medicine knowledge as a board certified herbalist into the psychedelic space, and joins us on the podcast today to discuss his ongoing petitioning of the DEA as well as his perspectives on the emergent psychedelics industry.

Dennis: So, one of the things I wanted to start discussing right away is a petition that you have written, and you are actively asking the DEA for people with terminal conditions to use their “Right To Try” laws. Can you explain a little bit more about what the “Right To Try” means?

The DEA can grant access to people for psilocybin therapy, right, which has cleared clinical trials in some cases. So it is not yet federally FDA approved, but it is on the track to that. What is this petition all about? And where do you see this motion headed in the near future?

Jonathan: The “Right to Try” laws are applicable in 38 different states and federally. They state that if someone is near the end of life, they have the right to try investigational new products; these products must have passed Phase I clinical trials, but are not yet FDA approved.

Psilocybin falls into this realm; it has already passed Phase I clinical trials. Compass Pathways and some other people have entered Phase II, or are finishing up Phase II clinical trials. However, the DEA is refusing people who are terminally ill the right to access such products.

They’re supposed to be allowing people access to the companies who are doing the clinical trials, so that they can use some of this to deal with some of the end-of-life depression and anxiety that comes along with it.

So, the amicus brief was filed by Dr. Sunil Agarwal and the Ames Institute – this is their third petition. They denied the first two petitions, saying “We will not even hear it; we will not even hold a public discussion on this.”

In essence, they are violating state and federal laws. The first two petitions did not go through; however, this third petition has a bunch of law firms and doctors, like myself, who have signed it.

Dennis: Have you had any experience in the past working with these legal frameworks? Obviously, taking on the DEA and attempting to get them to take you seriously requires a great deal of social capital and specialized knowledge of how to go about this process.

So, what precipitated this petition? How did you personally get involved in being in this position where you’re petitioning the DEA – which is a monolithic entity that a lot of people don’t know how to engage because it’s so massive, bureaucratic, and deeply entrenched? Is there any legal precedent for why you think you might be successful in getting them to take you seriously?

Jonathan: Well, I got involved personally through my attorneys who are representing me in this matter: Joseph Shapiro and Dan Mckillop. They are from New Jersey and they are part of the State Bar Psychedelic Association over there. There are a bunch of other law firms that have signed up.

After the first two petitions were denied, and when the DEA refused to even take it into public consideration, the firm representing Dr. Aggarwal put together a coalition of other attorneys, physicians, doctors, medical providers, and groups who support psilocybin therapy based on clinical research available.

You know, we know that these therapies work. There have been a lot of researchers that have come out specifically in the last 5 to 10 years that show that the therapies are effective, safe, and have passed clinical trials.

You know, we know that these therapies work. There have been a lot of researchers that have come out specifically in the last 5 to 10 years that show that the therapies are effective, safe, and have passed clinical trials.

So, I found this out from my attorney, Joseph Shapiro. We just happened to be talking about another issue; it’s funny how it started. I was booked unknowingly to moderate a panel at Cannadelic on the legal lessons that the psychedelic industry can learn from the cannabis industry.

Jonathan: 

So, I called Joseph; we’re friends from LinkedIn and he’s in the field. And I said, “Hey Joe, help me out here. What do I talk about? What am I moderating? This is not my field of expertise; I’m a clinician and hands-on in the clinic with patients on a day to day basis. However, I have done research; I have a doctorate and master’s in acupuncture and Eastern medicine, and am also a board certified herbalist. So, I have some experience in this field both personally and professionally.

But Joe says, “Well, you know, it’s funny that you mentioned this; this is good timing. We just got involved. We have another doctor that we’re representing and we’re looking to get people involved with this AIMS 3 appeal. Would you be interested in us representing you and your practice?

And I said, okay, well, tell me about it. I said that’s fascinating and I would love to.

So, it actually turned out really cool because not only was I able to sign on as one of the physicians supporting the matter, but I was also able to contribute some information. They were able to use some of my wording and language in the petition itself. I read the initial petition and saw that it was all geared towards the “Right To Try” which is for terminally ill patients, but they had only mentioned cancer and AIDS patients specifically.

And I said, “Well, listen, Joe Dan, this is a problem because when we look at terminally ill cancer patients and AIDS patients, this is not how it should be; however, we tend to just sweep them under the rug and say things like, “Oh, they’re dying anyway; they’re on their way out.”

I said, “Well, what about all these other conditions? What about Parkinson’s? What about multiple sclerosis? Alzheimer’s and all these other conditions that result in end-of-life stages? And what about the veterans?” We’re losing 22 veterans a day to suicide.

We’re losing 22 veterans a day to suicide.

So they told me there’s another petition going out specifically for the veterans. I said that I think that it needs to be included. So they were able to add some of that language.

I also noticed that the Compass trial had already finished Phase IIB and was already publishing results, which were not included. The results of this trial are one of the justifications showing the DEA that we have passed Phase I trials. So they added some of the research I was able to pull up on the Compass trial specifically into the brief as well; it feels really cool.

I work with patients who have various severe autoimmune issues, connecting mixed tissue diseases to cancer and other things. I’m stuck in the clinic, knowing that these therapies are working. I’m reading the research and seeing this reflected in what patients are reading in publications like Time Magazine or National Geographic—about SSRIs not working—and they are coming to me and asking for referrals to therapy but I can’t help them since I’m speaking at conferences.

I mean, I can refer to Ketamine clinics, but that isn’t for everyone. I’ve referred patients out to clinical trials, but sometimes they aren’t a good match for the trials. But what about suicidal teenagers and those under them? Unlike people who need help now, I cannot sell them medicine, I cannot prescribe it to them, and I cannot even legally refer them to this kind of medicine. That is why I wanted to get involved.

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