Greetings from London. We are bringing you this issue of The Frontier Psychiatrists newsletter from the Clinical TMS Society annual meeting!
I will go ahead and share with you a picture of the first magnetic induction coil— as made by Michael Faraday— which I spent time in the presence of last night.
And now…back to psychedelics!
I described issues with (or beat up on) MDMA-AT for the past 5 parts of this series. I’ve been critical of their manualized therapy…for those who need to catch up!
Prequel: Now, Everyone Is Interested in Drug Development
Should MDMA-AT Be Saved, Part III
That having been said, today is time to provide concrete advice on how psychedelic medicines can succeed in a novel context—medicine. Today’s article pertains to staffing, and we will get to technology thereafter.
We start with monitoring. I am going to start by saying— the activities that happen while patients are under the influence of a psychoactive hallucinogen? None of that is therapy. It’s medical monitoring. We have this happen regularly in other medical contexts ALL the time. Anesthesia, for example. The patients? They are in an altered state of consciousness and physiological changes, together. Monitored closely. Similarly, acute agitation is monitored in the ICU and emergency settings regularly. The ICU nursing staff might be therapeutic…but the activity is nursing care, not psychotherapy. We refer to this as psychological support in some clinical trials of psychedelic medicines:
The primary purpose of psychological support throughout is to ensure participants' physical and psychological safety and minimize the number of any potential adverse events.
It's a combination of niceness, professional judgement, and the ability to intervene to prevent problems. This set of goals and skills will be immediately familiar to anyone who has ever interacted with nurses. You know, the people whose names you bother to recall in the hospital. This is as opposed to the doctor in a hospital—what was her name?— who rounds for five min a day. She likely then spends the rest of the day furiously entering data in EPIC for billing and coding, if you were wondering.
Therapists—overwhelmingly PhD and Master’s level clinicians are trained to provide therapy after an experience, perhaps. Therapists talk to people after weird sh*t all the time. However, they have no medical training to know how to administer meds—that is a nursing job—or check vitals—again, nursing. Hell, as a physician I barely know how to actually administer meds—that is how much nursing is a separate gig owned by an entirely other set of medical professionals. The rest of medicine understands nursing is mandatory for medical care to happen.
When patients are altered…or, to quote anyone in my home town of Brooklyn, high? That is not the time for therapy. When people have a blindfold on? Not time for therapy. For 8 hours in a row? Absolutely not a plausible role for someone with 7 years in a PhD program—just so they can talk about it the next day?
But, readers may protest, the content of the session, while people are high, is important for the subsequent integration session. This is an empirical question, but I will kick the can down the road for now. This is why we have cool tech like MDHub.ai! This is an Ambient Scribe and more tool. Right now, it condenses 60 min of a therapy session I provide into a medical note. One can can read that note in one minute. AI solves this problem for therapists walking in the next day. Realistically, therapists go on vacation. They get sick. Coverage needs to exist. It’s nice to think the same human does every session for the same patient, but it’s not how the rest of medicine works. We have shifts, notes, hand offs, and AmIOn software.
Therapists are also uniquely skilled at hearing about what happened after the fact. They then figure out what to say about it after it happened. In fact, it’s their whole job. Therapy is usually “there and then with them.” Some of us would argue that “here and now with us” is an important therapeutic frame in Mentalizing therapy, but again, that requires sober patients.
As an added benefit, the amount of time that a Psychologist is needed for integration only? In this model, it is no longer many hours. Now, they can be scheduled like every other Psychologist in a regular office that does not need to have the assumed to be necessary elaborate set and setting to buttress the altered state itself. Practically speaking, it's cheaper if you guys use the same office to deploy this new therapy then if you need a space purpose built with, presumably, calming plants, water features, and Buddhist-adjacent statues.
The staffing of nursing is also more aligned with extended monitoring of patients in altered states! Nurses are routinely working 12 hour shifts. Nursing requires less time to train— 2 years for an RN degree after college— and associated technician roles on the nursing team, less time still. In the hospital, these individuals have been providing “constant observation” and psychological support for decades.
Physicians will be needed, and on site, for these psychedelic treatments. We require REMS (Risk Evaluation and Mitigation Strategy) certification on site for Esketamine, and 100% of these medicines will come to market with one of these REMS on the FDA-label. Prior products—Xyrem by Jazz Pharmaceuticals—is similar to psychedelics in an important respect. GHB aka sodium oxybate—a treatment for narcolepsy. This drug costs about a dollar to make. It costs something like $6-7k every 14 days. The protected intellectual property in this product is the REMS, and there has been excellent coverage of the nonsense that went on with this product was published in
’s On Drugs Substack.The point is—you can make plenty of money on a tightly controlled drug, for industry. This is by owning the risk mitigation intellectual property instead of the drug alone in a novel indication. This is called lifecycle management in pharma, and it is part of the business.
The more controlled the substance, the more restrictive the REMS, the more this approach becomes a meaningful barrier to entry for competition. Thus, this has the potential to be a profitable product without having to rely on selling tons of expensive therapy training to therapists. That business model ends up looking a lot more like NXVIM or Scientology than a biotechnology or medical company.
I am at CTMSS right now—and in real time, I am listening to Dr. Rodriguez from Stanford present on MDMA for OCD paired with ExRP therapy in clinical trials. We need more excellent treatments, and I believe MDMA will have a place at the table.
The field of psychiatry, working with industry, needs to get psychedelics right. I hope my proposed suggestions about who will need to be in the room will help. I will remind readers—what is needed, and when, will be empirical questions. We need to test assumptions, not just accept spiritually-based assertions in place of rigorous mechanisms of action. Further, humans need to deploy these treatments. Thinking about whom, under what payment model, and in what settings? These are as important as the magical power to make world peace a reality, man.
Enough polemic! The next installment will recommend technology solutions to augment the above assertions about staffing of psychedelic medicines.
Thanks Owen, nurse and psych np here and I 100% agree with how well suited nurses are to provide this care, so much so that I cofounded the Organization of Psychedelic and Entheogenic Nurses OPENurses.org and have published on the care delivered in PAT https://www.andrewpennnp.com/_files/ugd/52de8b_9cc6cd7e72b448f49d1d967843de4592.pdf
You’re on a roll brother! Preach 🙌🏼