Religious Use in Oregon; Psychedelics @ Davos; Wearable Brain Imaging
Religious Use in Oregon; Psychedelics @ Davos; Wearable Brain Imaging
***This piece has been revised to correct a few errors in the original version.***
Originally I had said: “The EPP would allow these organizations to produce their own psilocybin-containing products outside of the guidelines outlined in the original ballot initiative” this is incorrect. Author of the Proposal Jon Dennis informed me that “It would create a special manufacturing endorsement to allow entheogenic manufacturers to grow them in less regulated ways, but the manufacturing would still need to occur as provided for within Measure 109.”
I also included retracted a comment about the OHA’s likelihood to approve the EPP. It was ill-informed speculation
Kernel CEO Bryan Johnson alerted me to a response to Matt Wall’s piece by the company’s CTO, part of which I have added to the below commentary.
Dispatch from Oregon: Entheogenic Practitioners Proposal
Next week the Oregon Psilocybin Advisory Board (OPAB) will vote on a proposal to change the framework of the ballot initiative voters put into law in the 2020 elections.
The changes come from the Entheogenic Practitioners Proposal (EPP), which attorney Jon Dennis put forward to expand the privileges of religious or entheogenic practitioners under Measure 109.
Currently, religious use of psilocybin would be acceptable if it adheres to Oregon’s regulatory framework. But according to Dennis:
“If Oregon gives less than the most religious liberty that is available under M109, it would constitute a setback in the hard-fought progress that entheogenic religions have won over decades of struggle.1”
So there are two mutually reinforcing issues at hand here:
First, the framework of the ballot initiative does not include provisions for religious use, which, according to proponents of the EPP, makes it akin to government interference in religious practice and therefore unconstitutional.
The costs associated with regulations, including service center facility requirements, facilitator’s time and training tuition, and costs of regulated growing, testing, and transporting of approved psilocybin products, will make the price out of the range for most people.
So the EPP is basically a carve-out of the Measure 109 framework that would mitigate government interference by extending certain privileges to religious organizations operating within the 109 framework, which simultaneously would reduce the cost of delivering psilocybin services.
The proverbial two birds, one stone.
What are these privileges?
The EPP would
grant qualifying religious organizations service center licenses
allow for psilocybin experiences to be facilitated by community peers (volunteers) instead of paid and licensed facilitators
allow these organizations to produce their own psilocybin-containing products outside of the guidelines outlined in the original ballot initiative.“It would create a special manufacturing endorsement to allow entheogenic manufacturers to grow them in less regulated ways, but the manufacturing would still need to occur as provided for within Measure 109.”
The last two measures alone—peer support and ‘homegrown’ less regulated products—will tremendously reduce service costs.
The proposal has garnered the support of David Bronner, CEO of Dr. Bronner and the largest donor to the measure 109 campaign effort. In his letter of support to the OHA, Bronner said:
“I support the Entheogenic Practitioner program that Jon proposes, giving more freedom and leeway to sincere entheogenic communities, religious or otherwise, to safely practice and heal under the 109 program, and have the option to grow their own different varieties of psilocybin mushrooms cost-effectively as far as testing requirements.”
The proposal also received public support when the Oregon Health Association solicited public comments. In a post on Psychedelics Today, Dennis noted:
“The overwhelming majority of the public testimony received was in support of religious freedom, affordable access, and the community container for psilocybin service. The support was so overwhelming during the first meeting that I tried to keep tabs on the second meeting. I counted 31 total comments that were received. 24 of those 31 – or 74%! – voiced support for the adoption of the entheogenic practitioners framework for safely regulating community-based practice. I do not believe a single person testified in opposition to its adoption.”
With all that said, the OPAB, who will be voting on the proposal next week, is not the final decision-maker
That would be the Oregon Health Association Authority.
So even if the EPP fails to gain approval, it offers activists and legislators in other states a model for including religious and other entheogenic practices in their proposals.
A Neuroscientist’s Thoughts on Kernel Flow
When I first heard about the prospect of Pre-Approval Pragmatic clinical trials and Real-World Research, I had found my hobby horse.
I wrote about this idea more substantively in The Middle Way: Tech-Enabled Psychedelic Pragmatic Clinical Trials, which was based on the paper: Can pragmatic research, real-world data, and digital technologies aid the development of psychedelic medicine?
There is already widespread use of psychedelics even as the scientific knowledge base is young. Moreover, such use is often in settings that lend themselves to collecting data—retreat centers, for example—why not take advantage of it?
The uptick in commercial drug development for FDA approval and expansion of academic research to understand the mechanism and neurobiology are following the increasing use of psychedelics in the real world—ie. personal use, ‘underground’ ceremonies, or retreat settings in legalized jurisdictions.
Furthermore—and this is a primary thesis of this newsletter—psychedelics are entering the mainstream just as digital technology is making inroads into healthcare and clinical research.
This is the premise of the paper mentioned above about pre-approval pragmatic clinical trials:
“Here we propose that pragmatic trials, data registries and electronic data capture will aid advances in psychedelic medicine by catalysing our understanding of best practice, which includes, but is not limited to, identifying and mitigating risks…
Easy to sample biometrics (e.g. via wearable devices or sensors and simple electroencephalography) and behavioural sampling (e.g. natural language and phone-use) could accrue large pools of objective data with potential predictive value.
If such studies and data registries are designed with careful consideration of data quality and fitness, pragmatic research could create significant value for various different stakeholders, e.g. scientists, clinicians, regulators, health care systems, payers and investors.”
One such technology still in its infancy and not yet vetted and validated is a wearable brain-imaging device from Kernel.
Last week the company posted a promotional video about their collaboration with Cybin, who also published a press release about“the Cybin-sponsored feasibility study evaluating Kernel’s quantitative neuroimaging technology, Flow, to measure cortical hemodynamics while experiencing an altered state of consciousness.2”
The details were scant, but the prospect of a wearable brain imaging device that might allow for greater ease of capturing neuroimaging data mid-trip feels like an area of innovation that would be useful and interesting to have as the field of psychedelic science matures.
Something like the Kernel Flow seems like a great fit for advancing our understanding under real-world conditions. Still, with splashy new tech, the promises always come before pragmatism, so I was grateful to see Professor Matt Wall’s thoughts on Kernel.
Wall is a neuroscientist whose work focuses on fMRI, so he is a good scout for evaluating new imaging technologies.
From Professor Wall:
“So, what is the Kernel Flow device? It’s a wearable brain imaging device that looks like a kind of segmented helmet, and is based on time-domain functional Near Infrared Spectroscopy (TD-fNIRS) technology…
This is definitely a significant and impressive technical achievement. However, the amount of real data they’ve presented so far is pretty thin, and as a neuroimager and neuroscientist, I have questions. Lots of them…
These developments in wearable brain imaging devices like Kernel Flow (and the recent OPM-MEG innovations) can potentially mean that we can do neuroimaging outside the confines of an MRI or PET scanner; or even leave the laboratory behind and acquire functional brain data out in the ‘real’ world.
This is definitely an exciting prospect, however I think it remains to be seen whether the portability/ease of use are truly useful innovations, and outweigh the strong limitations on the quality and kinds of data that can be acquired from such devices based on fNIRS technology. I’m very much looking forward to seeing more data and formal write-ups from the Kernel Flow device and what kinds of data it can actually provide.
Kernel CTO, Ryan Field, followed up on Wall’s post on LinkedIn with a clarifying comment:
“The PSYCH talk was a 5 minute slot and needed to hit a wide audience, so there was only so much detail we could include.
Our devices have only been out in the world for about 9 months and, you are correct, our JBO paper is focused on showing the core technology in the device works and works well. The finger tapping example was included to show that it does indeed record signals from the brain, as expected! Over the last few months, we have started several larger studies and we’ll start to see results from them, including the full ketamine study with Cybin, later this year. We will definitely publish more as our work progresses.”
Further Reading
Psychedelics at Davos
Next week, during the World Economic Forum, Energia Holdings will be hosting the Medical Psychedelics House of Davos.
The programming includes talks and discussions with many experts and stakeholders, including David Nichols, Rachel Yehuda, and Amanda Feilding, focusing on the “regulatory approval for these compounds, their therapeutic potential, policy, safety and efficacy, biocultural preservation, drug development pipelines, and patient access.”
Inside the Dispute Over a High-Profile Psychedelic Study
“As psychedelics have gained more respectability, though, the pendulum has been swinging the other way again: not back toward stigma or calls for prohibition, but away from uncritical hype and toward a desire for a more circumspect approach to the research, its processes, and the claims that can be made about it.”
BrainFutures Report: Expediting Psychedelic-Assisted Treatment Adoption in Clinical Settings
“The promise of these psychedelic compounds raises great hope for PAT’s potential to relieve pain and suffering for millions of patients. The path from research to clinical adoption, however, is still lengthy and challenging. As the industry prepares for this next critical stage, BrainFutures seeks to highlight the importance of a shared set of fundamental principles to guide key decision-makers in this process. These principles are:
PAT must be accessible to all patients who qualify for, and would benefit from, such therapy.
PAT must be affordable for all patients who qualify for, and would benefit from, such therapy.
PAT must meet high quality standards to ensure optimal patient outcomes.
That’s it for this week. Thanks for reading!
Zach
Slide 31
https://www.bloomberg.com/press-releases/2022-05-09/cybin-and-kernel-announce-results-from-kernel-flow-piloting-of-feasibility-study-measuring-ketamine-s-effects-on-the-brain-l2z66shr