Group Ketamine Pilot; Therapist Training Platform's Seed Round; Durable Response to PAT at 12 Month Follow up
Sometimes the news of the week happens to be thematic.
Last week, the theme was Innovation. This week it is Care Delivery.
Today we’ll look at:
Thanks for reading 🙏 I hope you enjoy it.
Before the week’s news analysis, a quick preamble on the divide between innovation and care delivery in modern healthcare systems.
Innovation (commercial biotech and life sciences companies) and
Care Delivery (providers, payers, health systems, pharmacies, etc.).
I included this quote in The Last Mile Problem Part 2: The Innovation and Delivery Divide:
One of the things I’ve realized is that those of us in [Innovation], we’re not thinking [about] and paying attention and not interacting with the world of our health systems, the payers, the employer groups, the governments who pay for innovations, the provider groups. Those worlds, the worlds of medical innovation and the systems that deliver those innovations to make life better don’t intersect… in innovation, we say “if we just make it, and if it is incredible, then it will all be fine.”
Novel innovations and new treatment paradigms are needed and worth pursuing. But if the Care Delivery systems and incentives are ill-equipped to deliver these innovations to patients, there’s a problem.
“There's some kind of last-mile problem. You can turn to the newspapers and read all kinds of fantastic stories—new research, new ideas, new tools—but when the rubber hits the road, people living longer, we're spending more and more and more for exactly the same returns. So if that trend continues…the question becomes, you know, where does all the progress go?”
Psychedelics are not new.
Humans have been using them for millennia; therefore, their introduction into the modern healthcare systems and Care Delivery frameworks is the real innovation.
On to the week’s developments.
🧑⚕️ Group KAP for Frontline Healthcare Workers
From the press release:
“Novamind…is pleased to update shareholders on a clinical pilot investigating the efficacy of group ketamine-assisted psychotherapy for frontline healthcare workers (“Frontline KAP”). With the final cohort of participants expected to begin treatment in March 2022, data analysis is currently underway and will be published following completion of the clinical pilot.
Frontline KAP represents a unique opportunity for Novamind to scale an innovative research pilot into a novel treatment program and make it accessible at all Novamind clinics. The pilot launched in July 2021, in partnership with Colorado-based Wholeness Center.
Novamind Medical Director Reid Robison shared some details with me about the program:
It is not research but a pilot program to establish feasibility as a future treatment offering at their facilities.
Groups of four healthcare workers met weekly for six weeks with two facilitators for a combination of treatment and integration sessions.
Dosing was escalated from sublingual low-dose to sublingual medium-dose and ultimately high-dose intermuscular injections.
They expect 40 frontline healthcare workers to complete the pilot program.
Psychedelic Clinical research has primarily been in individual formats, with a single participant undergoing therapy with one or two therapists. This research will inform regulatory approval and practice guidelines in conventional healthcare settings.
However, group sessions have been the dominant form used throughout history in indigenous, underground, and retreat settings.
In a recent paper that explores the role of the group and interpersonal connection in psychedelic experiences, Psychedelic Communitas: Intersubjective Experience During Psychedelic Group Sessions Predicts Enduring Changes in Psychological Wellbeing and Social Connectedness, the authors state (emphasis added):
“…naturalistic settings in which psychedelics are taken almost always involve their use as a collective activity, raising the question of how psychedelic substances may acutely affect the experience of intersubjectivity, i.e., human interaction, relation, and collective emotion, and how such psychosocial dynamics might, in turn, act upon the psychological constitution of the individual.
Despite the small amount of clinical research with groups, such settings are an attractive path to scalability and reduced costs upon FDA approval and roll-out of legalized frameworks like Oregon’s Measure 109.
Furthermore, there is reason to suspect that group facilitation may offer better outcomes than individual approaches in some contexts.
As Dr. Robison told me,
“there's the added kind of healing power of a group. But then there's also the cost-effectiveness of delivering in that way. And the in certain conditions like burnout and some types of trauma that helps people realize they're not alone in it.”
Again, from Psychedelic Communitas (emphasis added):
“…the present study provides novel evidence of enduring prosocial and psychological benefits derived from the experience of communitas during a collective psychedelic experience. In particular, post-psychedelic improvements in wellbeing, social connectedness, depressive symptoms, trait anxiety, and interpersonal tolerance, were found to be positively associated with the extent of communitas experienced during psychedelic ceremonies….”
Cohorts: Common Identity and Shared Purpose
As mainstreaming rolls on, we see niche communities forming around integration. These groups are often based on common identity and shared purpose and could be excellent vectors for facilitated group sessions.
However, the inverse is also true.
Therefore, a significant amount of harm reduction will come from understanding which patient populations should NOT participate in group formats despite their common identity and shared purpose.
Again, Dr. Robison;
“We do have to be careful with the groups that are being assembled because it is very different to assemble a group of health care workers with burnout, stress, and perhaps even post-traumatic symptoms that are work-related… It is different to assemble that group compared to trying to put together a group of PTSD where you might have severe childhood sexual abuse and combat veterans in the same room. There are some kinds of conditions or even with the same diagnosis in my opinion, and many people's opinions, you wouldn't want to combine, or you wouldn't expect a value add, it might even be counterproductive.”
Unmet Need + Therapist Shortage
Compounding the need for group facilitation of psychedelic therapy is the already dire shortage of mental health service providers.
“Unfortunately, our current mental health workforce is inadequate to meet the swelling demand that over a year of pandemic life has brought about. The pandemic has expanded the hairline cracks in our mental health care system to full-on fractures.
I fear that the inability to access mental health care is about to get worse.
Why? The answer may surprise you: psychedelics.”
Penn notes that PAT’s time and labor demands will only further exacerbate the matter, given how many therapists are keen on using psychedelics in their practice.
Alternatively, the rise of psychedelic therapy could excite so many would-be therapists and lead to the profession’s growth.
Either way, group therapy should become a priority for researchers and commercial developers alike to enable scalability and accessibility.
🛋️ Therapist Training Platform Fluence Raises $3 Million Seed Round
From Business Insider:
Fluence, a psychedelics-focused educational platform, announced Tuesday that it had raised $3 million to train therapists and other practitioners to administer psychedelic treatments for mental health.
Twenty-four months ago, the idea of a therapist training program raising venture capital seemed unlikely. At the time—and I think this still holds—the overwhelming majority of investment into psychedelics went to drug development programs.
Now, as legal psychedelic therapy inches closer, urgency is setting in.
There is perhaps a greater appreciation and understanding of the need for “picks and shovel” businesses required for Care Delivery.
At the top of that list are therapist training programs.
Fluence COO Michael Kuntz:
“if there's not enough trained mental-health professionals to actually shepherd these drugs out to the patient population, then how are these companies going to ultimately succeed in the future," he said, adding that investing in Fluence was also a way for some of these investors to protect their biotech investments.”
It is taken as given that MAPS’ MDMA Assisted Therapy for PTSD will receive FDA approval.
At that point, the primary bottleneck to the roll-out will be a sufficient number of licensed and trained therapists.
In Unbundling Psychedelic Therapy, we explored how current PAT protocols will adapt for scalability and accessibility.
The primary levers to pull in this regard are group therapy, as we discussed above, and leveraging technology to free up therapists’ time and reduce patient visits.
However, in the same vein as the Innovation and Care Delivery divide mentioned above, psychedelic therapy is interpersonal and technological innovation tends to overlook such nontechnical aspects.
There is no getting around or shortcutting the need for compassionate, empathetic, and capable humans.
So it is reassuring that investors see the value in such a crucial component of Psychedelic Medicine.
📆 Study: PAT Shows Durable Response at 12-Months, But not a Silver Bullet
A new publication from researchers at Johns Hopkins shed light on the durability of PAT for depression, finding that for the majority of participants, the antidepressant effects were durable at 12 months.
From lead author Natalie Gukasyan’s Twitter thread announcing the publication:
As is the case with all psychedelic research (ney, ALL research!), the devil is in the details.
Despite the remarkable effects a third of participants began taking antidepressants, and 42% continued with psychotherapy after the trial ended.
Very Effective Tools, Not a Panacea
As pointed out amidst the recent hype and enthusiasm, psychedelic therapy might better be thought of as the start of a healing journey, not the end.
The ‘psychedelics as a silver bullets/miracle cure’ narrative is tough to contain, especially as the field receives more mainstream coverage.
The balance between hope and hype is a significant challenge.
That’s all for this week; thanks for reading, and see you next time.