What if the 'Psilocybin vs. Escitalopram' trial used Digital Biomarkers to measure results?

Welcome to "Late-Stage" DSM based categorization of mental disorders

Quick Summary

  • Milestone trial results published in NEJM comparing psilocybin to the antidepressant escitalopram for the first time

  • Paradoxically, results are both inconclusive and favor psilocybin over Escitalopram in the treatment of depression.

  • How we “measure” “depression” in research is fundamentally flawed

  • The psychedelic renaissance is coinciding with fundamental changes in the measurement and classification of mental disorders

  • Digital Biomarkers will replace multiple-choice surveys as the Research Domain Criteria (RDoC) overtakes the DSM and psychedelics1 overtake the antidepressants.


Last week, Robin Carhart-Harris and co-authors published the results of the first head-to-head comparison of psilocybin vs. an antidepressant in the prestigious New England Journal of Medicine.

The most common impressions/comments/takeaways:

  1. Bravo! A well-done, first-of-its-kind comparison trial of psilocybin and Escitalopram. Kudos to the authors. A milestone for the field.

  2. The study was inconclusive2 because it was underpowered3. The primary outcome measure, the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), revealed that patients in both groups improved, the psilocybin group improved more, but not enough to be considered clinically significant.

  3. The real results are in the secondary outcomes—all of which favored psilocybin.

Call your shot before you shoot your shot

Good science requires that you declare what you are going to do and how you will measure it, before you do it.

It is like a game of horse; you have to call your shot before you shoot. If you call “bank shot4” and your shot doesn’t hit the backboard but still goes in, it doesn’t count.

In this case, the Imperial team called their shot when they decided to use the QIDS-SR-16 as the primary outcome.

They also used other measurements, secondary outcome measures, which are useful, offer additional insight, and will help inform future trial design. Still, since you can only have one primary outcome measure, they don’t “count” when officially drawing conclusions.

As lead author, Robin Carhart-Harris lamented, the choice was almost arbitrary:

“This study used multiple depression measures (QIDS-SR-16, HAM-D, MADRS, BDI-1A) among which QIDS was defined as primary, a largely arbitrary choice, and in hindsight, not a good one. This was the only outcome measure where the psilocybin vs SSRI difference was not statistically significant. It was significant on all of the other depression measures!

"in saying no conclusions can be drawn on the secondary outcomes due to the absence of correction for multiple testing, we are recognizing the risk of false positives when casting a wide ‘fishing net’. However, when one factor in how consistently the secondary outcomes favoured psilocybin and by what margin, it is easy to suspect that the miss on the primary outcome is in fact a ‘false negative.’”

Here is a graph of the secondary outcomes Dr. Carhart-Harris refers to, showing psilocybin superior in virtually all categories.

In other words, we have a situation in which the researchers were like a guy chosen from the crowd to shoot a full-court shot at halftime of an NBA game for a million dollars—but he has to call his shot. Thinking a 90-foot hurl has a better chance of going in off the backboard, he calls “bank shot” only to throw up the shot of his life that goes in perfectly, nothing but net.

Doesn’t count.

Then I saw this from Boris Heifets:

“The inconclusive outcome may say more about a generation of psychiatric scales designed for SSRIs than it does about psychedelic potential”

Dr. Heifets’ offered more insight via the excellent write up from Psilocybin Alpha:

"It’s more likely than not that existing metrics for depression are just not well suited to studying psilocybin and measuring its impact, e.g. emotional breakthroughs, meaning-making, spirituality. Hopefully, the field will evolve and broaden its horizons."

I started wondering, “How do we measure depression?”

Which lead me to, “What is depression? How do we define it? How can a subjective experience possibly be objectively quantified? Am I depressed?”

Which, of course, eventually leads to the question of “what does it mean to be conscious and sentient?”

The slide from asking "How is depression measured?" to "What does it all mean and why am I here?" is well oiled. Before we build up too much speed down this slipperiest of slopes let's actually look at how psychiatry/psychology researchers "measure" "depression" and how that will be changing.

Depression, Measured

Do you know how psychology, psychiatry, and mental health researchers measure depression?

With surveys.

Self-rated, multiple-choice questionnaires5.

At a time when we have a global, anonymous, peer-to-peer digital currency with a $1 trillion market cap; when the rockets used to launch space shuttles into orbit are returned to earth with pinpoint precision, when waste carbon dioxide can be removed from the atmosphere—we are still using multiple-choice surveys to measure mental health conditions6.

DSM Based Surveys

The Diagnostic and Statistical Manual of Mental Disorders (DSM) is a universally loathed artifact of psychiatry’s attempts to quantify and qualify subjective human suffering. It seems to be universally loathed for reasons related to reimbursement, big pharma, big healthcare, and Rene Descartes.

Psychiatrist & writer Scott Siskind:

“Remember, the DSM is fundamentally a diagnostic guide. It’s a list of criteria to determine who has eg depression. To oversimplify just a little, if a patient has five or more of their depression criteria, then they “really have” depression, and a psychiatrist should diagnose them. If they only meet four or fewer, they don’t have depression, and should not get the diagnosis. All of this is predicated on the idea that there’s a specific thing called depression that you either do or don’t have.”

The primary outcome measure of the psilocybin vs. Escitalopram study was the QIDS-SR-16. This is a self-rated, multiple-choice survey composed of 16 items that correlate with the DSM-IV symptom criteria for depression.

Below is an example of the type of questions the QIDS-SR-16 asks and the four response choices:

The other 15 multiple choice questions ask for similar ratings about sleep, appetite, restlessness, and the subjective feelings of weight gain or weight loss, concentration, energy, restlessness, suicidal thoughts, and interest levels7.

A similar survey used as a secondary outcome measure is Beck’s Depression Inventory. Beck’s is a 21 question, multiple-choice survey very similar to the QIDS. Another is the Hamilton Depression Rating Scale, again with similar questions, presented with multiple choice answers.

All of these surveys are meant to identify symptoms that, when present in sufficient quantity and intensity, create the experince we call depression.

This is by no means a critique of the researchers or their study design choices. There are constraints and considerations, measurement processes need validation, and it seems there are no good options.

But isn’t it telling that potentially paradigm breaking research on the leading cause of disability worldwide is resigned to using paper and pencil surveys to measure outcomes while we are all walking around with supercomputers in our pockets?

Supercomputers that can collect the very phenomena these surveys seek to capture— mood, behavior, activity, sleep, word choice, communication, and emotions.

Why not make use of it8?

Technology is required to move past the DSM

There is a paradigm shift underway in mental health research in which the classification system is transitioning away from DSM towards a new framework called the Research Domain Criteria (RDoC).

In 2013 the National Institute of Health (NIH) decided that the DSM was basically useless and stopped funding mental health research based on DSM categories.

Then director, Tom Insel wrote:

“While DSM has been described as a “Bible” for the field, it is, at best, a dictionary, creating a set of labels and defining each. The strength of each of the editions of DSM has been “reliability” – each edition has ensured that clinicians use the same terms in the same ways. The weakness is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure…

Patients with mental disorders deserve better. NIMH has launched the Research Domain Criteria (RDoC) project to transform diagnosis by incorporating genetics, imaging, cognitive science, and other levels of information to lay the foundation for a new classification system…

Here’s what’s happening:

  • DSM—>RDoC

  • Self-report surveys/structured interviews—>Digital Phenotyping

RDoC and Digital Phenotyping

Last year in Psychedelics & Digital Phenotyping, I wrote:

From Harvard's Digital Phenotyping and Beiwe Research website:

““What is digital phenotyping?” We define digital phenotyping as the “moment-by-moment quantification of the individual-level human phenotype in situ using data from personal digital devices, in particular smartphones.”

The critical takeaway is that digital phenotyping relies only on gathering data from regular interactions one has with their phone, such as swiping, typing, scrolling, speaking, etc. NOT the "active" answering survey questions or responding to prompts throughout the day.”

The collection and analysis of these data streams are required to move past the category-based framework of the DSM to an “alternative [with] a focus on psychopathology based on dimensions simultaneously defined by observable behavior (including quantitative measures of cognitive or affective behavior) and neurobiological measures9.”

This alternative is the RDoC.

The ‘Godfather’ of digital phenotyping, JP Onnela, and colleagues note in the journal Translational Psychiatry:

“Combining the RDoC framework with digital phenotyping offered from smartphones and other connected devices presents a unique opportunity for psychiatric research. Through incorporating the potential of these new digital technologies into RDoC framed clinical questions, psychiatry can now explore new dimensions of pathology largely inaccessible only a few years before.”

So, the future looks like this: sleep, activity, situation avoidance, energy, mood, attention, focus, lethargy, emotional valence (positive affect, negative affect), and other data points will be passively collected and analyzed.

The result of this process is information that can then inform diagnosis, treatment and personal health practices.

The optimistic take is that in the future we will be evaluating the effect of psilocybin and escitalopram on discrete dimensions objectively captured in order to understand the organism-wide response, not rely on self report surveys.

In other words the term depresion and the current way it is defined and diagnosed is under intense evolutionary pressure.

Digitally Equipped Psychedelic Research

So how might the results of future psychedelic clinical trials be informed with the advent of digital biomarkers and digital phenotyping?

We may soon find out.

Compass Pathways is in Phase II of COMP360 for Treatment-Resistant Depression. The primary outcome measure is the Montgomery Asberg Depression Rating Scale, a clinician-rated scale based on the DSM schema.

But Compass is also employing digital phenotyping technology through a partnership with Mindstrong, a company founded by the above-mentioned Tom Insel, former director of the NIH who oversaw the transition away from the DSM and member of Compass’s Scientific Advisory Board.

I bet we see a similar situation when Compass publishes their Phase II data that we just saw with the psilocybin vs. escitalopram trial. The primary outcome, a DSM based measure, will fail to capture the “real” impact10 that data from digital biomarkers will show.

And then there are the crucial matters of privacy, surveillance, data ownership, and portability.

Along with the challenges of intellectual property and patent disputes, this is another domain that will be contentious.

This seems like an area for collaboration, open source and blockchain projects to create competitive technologies in which individuals own their data and know where and how it is being used11. Beiwe is an open-source digital phenotyping and analysis program from JP Onnela that researchers can use for this.

In closing, the prospect of psychedelic medicine is exciting in its own right. But I think it is so fascinating that the psychedelic renaissance is coming of age at a time when the measurement and classification systems of mental health conditions are under enormous evolutionary pressure and changing.

It really is a paradigm shift.

1

broadly speaking. This includes empathogens, entactogens, the “tripless” psychoplastogens, etc.

2

Technically, the conclusion is that no conclusions can be drawn. Or that psilocybin is at least no less effective than Escitalopram. Scientists can correct me here.

3

Prof Kevin McConway, Emeritus Professor of Applied Statistics, The Open University: "The trial was not large, involving only 59 patients, and in several ways, the results were rather inconclusive… The lack of statistical significance means that we can’t rule this possibility out."

Prof Guy Goodwin, Emeritus Professor of Psychiatry, University of Oxford: The present study is not a quantum leap: it is underpowered and does not prove that psilocybin is a better treatment than standard treatment with escitalopram for major depression.

Dr. James Rucker, Lead for the Psychedelic Trials Group @ King’s College London, NIHR Clinician Scientist Fellow, and Consultant Psychiatrist, The Institute of Psychiatry, Psychology, and Neuroscience (IoPPN), King’s College London: “It is possible that the study was not adequately powered to detect a difference, or that this represents a true finding that the treatments are equivalent in terms of patient-reported outcomes, when delivered in this context. This is important, because other trials have indicated very large effect sizes for psilocybin therapy and the interpretation of this by some is that psilocybin will be more effective than established treatments for depression."

4

A “bank shot” is when the ball hits the backboard before going through the hoop.

5

And structured interviews.

6

This is not meant to be a critique of researchers or validation processes from someone completely outside the field. I hope it doesn’t come across as such.

7

If people could compare their self-rating of these factors against objective data that would probably be really effective. Is anything like this out there?

8

The risks, ethical considerations, and incentive structures are under fierce debate. Add psychedelics to the mix, and the bioethicists among us have their work cut out for themselves.

10

I mean, regardless of whether it is clinically significant or not, the more sophisticated picture of the results will come from digitally captured datasets.

11

If you’re working on this, I would love to hear from you

East meets Tech: Digital Shamanism & Closed-Loop Psychedelic Therapy

Hello!

On the occasion of my recent appearance on the Business Trip Podcast, where I spoke with Greg Kubin of the Psychedelic Medicine Syndicate, I wanted to say hello, and update you on future plans.

I also want to share some thoughts on my current fascination—the interface between technology and psychedelics, specifically what Adam Gazzaley calls Closed-Loop Psychedelic Therapy.

For new readers, this is a good place to start to get a sense of what The Trip Report is all about.

Listen here

The Trip Report Update

The last few months have been wonderful and challenging. As any parent will know, a new baby in the family wreaks havoc on routine, sleep, plans, sanity, etc. So I decided to hit pause on writing 3 times a week, rest up and think about the future.

And change diapers.

Fortunately, I have met some wonderful people, and we have exciting plans that I look forward to sharing with you in the coming weeks.

East meets Tech: Digital Shamanism & Closed-Loop Psychedelic Therapy

TL;DR

  • Robin Carhart Harris Joins UCSF’s Neurscape Lab

  • Neuroscape, headed up by Adam Gazzaley, develops Closed-Loop Human-Computer systems that target cognitive and neurological conditions and brain optimization.

  • Closed-Loop systems work by driving neuroplastic changes by applying adaptive loads on targetted neural circuits. Psychedelics “soften” these circuits making them malleable. combine the two and….

  • Closed-Loop systems create the possibility for effective and scalable tech-enabled psychedelic therapy.

Robin Carhart-Harris Joins UCSF & Adam Gazzaley Officially Steps into Psychedelic Science

OK, this is exciting:

Psychedelics research in support of brain health is getting a major boost this month with the formation of the Neuroscape Psychedelics Division at the University of California, San Francisco (UCSF). Through $6.4M in private funding, the new division will take a unique translational research approach to integrate cutting-edge neuroscience technology with psychedelics treatment...

"Heading up the new Neuroscape division as Founding Director will be Robin Carhart-Harris, one of the most cited researchers in the world in psychedelic science and the founder of the first center for psychedelic research at Imperial College London. "The founding of this new division is a hugely exciting development in the story of the psychedelic renaissance," says Carhart-Harris, who is the newly endowed Ralph Metzner Distinguished Professor of Neurology and Psychiatry at UCSF. "I'm delighted to be joining UCSF and the Neuroscape team and hope to steer this new division to great success." (emphasis added)

This is big.

Why?

The world’s foremost psychedelic researcher is joining the world’s foremost translational neuroscience lab at one of the world’s foremost biomedical research institutions.

If you’re reading this, you probably know who Robin Carhart-Harris is, but you may not know about Neuroscape or its founder, Adam Gazzaley.

Neuroscape is “a translational neuroscience center at UCSF engaged in technology creation and scientific research to better assess and optimize brain function of both healthy and impaired individuals1.”

Founded and led by neuroscientist and neurologist Adam Gazzaley, Neuroscape developed the core technology that underpins the first FDA-approved video game to treat ADHD. Gazzaley is a co-founder and chief scientific officer of Akili Interactive, which developed EndeavorRx, the video game approved for ADHD, last summer.

I didn't realize it at the time, but we touched on Neuroscape’s technology in June of last year in Software-Assisted Psychedelic-Assisted Psychotherapy: Part 1 when discussing the first FDA approval of a video game as a treatment for ADHD:

This announcement from ATAI comes days after a watershed moment for the field of Digital Therapeutics.

The FDA approved the first video game for the treatment of ADHD developed by Boston based Akili Interactive.

“The U.S. Food and Drug Administration (FDA) has granted clearance for EndeavorRx as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). Delivered through a captivating video game experience, EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue”

The FDA's approval of Akili's EndeavorRX was significant, not merely for the irony of the headline "FDA Approves Video Game for ADHD" but because it marked an inflection point in the field of digital therapeutics.

Again from June's dispatch:

“This is significant because digital therapeutics (DTx), as a field, has been limited in its ability to create a therapeutic effect directly.

The term has referred to the use of digital and Internet-based health technologies to make behavioral and lifestyle changes that indirectly affect clinical endpoints through behavior modification, this is what we mean by DTx 1.0.

However, Nikhil Krishnan, healthcare analyst and author of the Out of Pocket newsletter, made the case that Akili’s EndeavorRX marks the leap from Digital Therapeutics 1.0 to 2.0 on yesterday’s A16Z podcast.

“One really cool thing about this is Akili is a therapeutic through and through. It is not trying to incentivize a behavior change to induce the therapeutic effect. The goal of the video game is to actually induce the therapeutic effect directly which brings a lot of the promises of true scaleability.””

Closed-Loop Human-Computer Systems

The technology that enabled this leap from Dtx 1.0 to 2.0 is called Closed-Loop Human-Computer System or what the creator, Adam Gazzaley, calls “Closed-Loop algorithms for experiential treatments.”

From the Neuroscape website (emphasis added):

“Our goals to improve quality of life for both healthy and impaired individuals are focused at creating and validating new approaches to better assess and optimize brain function. We propose that the most effective approach to accomplish this is via dynamic interactions with a closed-loop system.

In this context, a ‘closed-loop system’ is one where: (1) an individual is challenged by an intervention, (2) the influence the challenge has on the individual is recorded in real-time, (3) these data then immediately update the challenge to be more effective in eliciting the desired response. The cycle then begins again with the updated challenge being reapplied, and real-time data being again collected and used to update the challenge. This closed-loop cycles over and over again – targeting and personalizing the challenge to the individual at every pass.

The closed-loop allows for high precision, personalized data to be collected so we can rapidly assess where an individual begins, and how to keep him/her at the edge of their ability for optimal learning.

In Neuroscape’s Technology division, we create closed-loops between an individual and custom-designed video games. Video games are an ideal platform to create closed-loop systems, as they are interactive and fun, leading to deep engagement.”

Challenge, Stressors, and Neuroplasticity

I want to acknowledge the risks of overselling technology, especially in healthcare, that creates outsized power dynamics between tech operators and users2. But the techniques discussed here make so much intuitive and conceptual sense to me based on the ups and downs of my own mental/emotional wellbeing and the science of biological tissue remodeling (aka neuroplasticity)3.

Here’s how I think about it:

The word ‘challenge’ was mentioned six times in one paragraph in Neuroscape’s description of closed-loop technology.

Why?

When I hear Adam Gazzaley explain the premise of closed-loop systems he often begins with exercise.

Lifting heavy things causes muscles to grow in size and strength. If muscles aren’t stressed enough, they don’t grow. If they are stressed too much, they get injured.

It turns out that all biological tissues, including neural circuits, operate according to this same principle. This dose-response relationship is generalizable across systems. It goes by many terms, but the basic framework is called hormesis.

Challenges come in a few flavors. There are cognitive challenges like learning a new language. Physical challenges like weightlifting and endurance exercise. Metabolic challenges like fasting and thermal conditioning. There are also psychological and emotional challenges like confronting fear and reliving traumatic events.

Such biological stressors and challenges cause structural and functional changes in biological systems according to predictable dose-response relationships, and we can leverage them for health-promoting and healing.

In closed-loop digital therapeutics, the challenge imposed by the increasing difficulty of a sensory-motor experience (video game) applies an adaptive pressure to the neural circuits involved. In the case of the EndeavoRX game for ADHD, the adaptive pressure is on the neural circuitry that governs attention and working memory.

This challenge changes the structure and function of the circuits that are “loaded” by the sensory, motor, and cognitive demand of the video game through a process called experience-dependent neural plasticity.

Dr. Gazzaley from his recent appearance on The Tim Ferriss Podcast:

“Probably what makes EndeavorRx so unique, as well as the dozen other video game technologies that we have at Neuroscape… they’re all closed-loop. What that means is that real-time data about your state, and it may be very simple data like your performance data, how fast or accurate you are, feeds into a processor, a computer, that records that data, makes a decision about it and then updates your environment. The challenges that you’re experiencing, the stimuli, the rewards that you’re being exposed to, and it goes on and on constantly adapting.

That’s why I made the analogy to a personal trainer. Imagine going to a gym and having a trainer that has access to every aspect about you in the moment. And also this ability to change things so subtly, to just push you to the next level. That is what this closed-loop system does.”

But, what does this have to do with psychedelics?

I’ve become convinced that:

  • Closed-loop systems will enable safe, scalable, and effective psychedelic medicine.

  • Closed-loop systems will empower human therapists, not replace them.

  • Rather than usurp traditional wisdom systems, closed-loop technology has the potential to breathe life into millennia-old healing practices like shamanism, contemplative traditions, and other lineage-based practices under intense extinction pressure.

Again, Dr. Gazzaley from Tim Ferriss’s Podcast:

“I think that what we’re doing here is building a set of tools, really sophisticated, informed, data-driven tools that will allow a therapist or any practitioner in the space to be more effective at helping their patient. That is what I hope and believe will come from this long journey. And that technology will be what it always should be, is just another human tool…

“Now, let’s talk about psychedelics. I described to you a system where technology enables multimodal biosensing, so we can understand your state in real time. And I described us having the ability to change what you see, hear, smell, and feel. So we have the two sides. We have the ability to know what’s going on with you, and we have the ability to shape your environment. What we didn’t talk about is what you just said: creating a closed-loop psychedelic experience. That is the goal here.”

The closed-loop systems apply adaptive pressure (challenges) to targeted neural systems, thus provoking selective neuroplastic changes.

Psychedelics, molecularly speaking, create an environment in which these neural circuits become more malleable and changeable.

Combine them, and the implications are incredibly compelling.

1

https://neuroscape.ucsf.edu/

3

Really should be bioplasticity since changes in immune, endocrine, even soft tissue are implicated.

Best of The Trip Report

Hi,

Thanks for checking in.

In case this is your first time here, The Trip Report is a newsletter created by, me, Zach Haigney. It is an attempt to explore and understand the complex and nuanced challenges and opportunities in psychedelics.

The Trip Report is currently on hiatus but here are a few of my better posts.

The 'Last Mile Problem' for Psychedelic Medicine

The Machine Elf will see you now: DMT in clinical Medicine

Psychedelics for Chronic Pain? The Problem and The Unmet Need

Psychiatrists & Decriminalize Nature Oppose Oregon Ballot Measure

Software-Assisted Psychedelic-Assisted Psychotherapy: Part 1

Slowing Down

Dear Readers,

It is time to think about the next chapter of The Trip Report.

I have decided to take a hiatus from the 2-3 posts/week schedule that we've been on for the last year. I will continue to write but not as frequently or on a predetermined schedule.

I want to develop better ways of exploring the burgeoning psychedelic space in all of its complexity and because the landscape is changing, what has worked until now feels stale and insufficient for the future.

It is time to hit reset.

So I have paused subscriptions of The Trip Report Pro while I change course and figure out the next phase. 

This effectively means the next bill date on your current subscription will be pushed out appropriately. If you have 12 days left on a monthly subscription right now, you’ll still have 12 days left when I resume. If you have 289 days left on an annual subscription, you’ll still have 289 days.

The End of the Beginning

I am not quite sure what the future holds, but I am excited about it.

As Winston Churchill said,

"Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning."

Over the next few weeks, I will be taking some time to think about the next phase, test different formats, get reader feedback and try to have some fun.

When I decide to restart subscriptions I will be sure to let you know.

As always, thanks for reading and supporting The Trip Report.

See you soon,

Zach

MDMA Saves Money; Can Psychedelics Save America? Science & Religion; Business Highlights

Psychedelic News Roundup

In Partnership with Lucid News

Policy

Can Psychedelics Help Save America?

A Healthcare and bioethics group at Harvard Law school is hosting a panel discussion of this very question:

"This panel, along with its companion Bill of Health symposium, attempts to answer the following questions: Can psychedelics benefit those not helped by modern medicine? Could they help political rivals find common ground and work together to build a better future? Can their benefits be accessed equitably, without leaving vulnerable groups behind and reinforcing patterns of oppression and exploitation? Can they revitalize the economy by creating new industries? Can they offer a model for harm reduction that could help address the opioid epidemic?

In other words: can psychedelics help save America?”

If Bill Clinton said: “it depends on what the meaning of the word ‘is’ is.

The answer to the question “can psychedelics help save America?” depends on what your definition of the word ‘save” is.

Canadian Parliament is on the clock

With a focus on Oregon and Washington DC, I missed that the petition to decriminalize plant medicines in Canada was read in the House of Commons a few weeks ago.

The Canadian government has 45 days to respond.

From Linkedin:

“Our petition to decriminalize plant medicines in Canada was presented in the House of Commons by Paul Manly MP on September 30th, 2020.

The Canadian government now has 45-days to respond to this petition that was signed by 15,000 Canadians. Entheogenic medicines could be the crucial missing piece in healing epidemic rates of depression, anxiety, PTSD, and drug addiction while empowering people to realize greater l wholeness, purpose and connection. Join us in support of decriminalization!”

Related: How a Canadian Decriminalization Model Can Improve on Portugal

Science & …Religion?

Odd bedfellows, eh?

Given the attention placed on drug development, clinical trials, and psychedelics as therapeutic tools, it is easy to forget that historically there has been an overlap between religious and medical practice. There is evidence, clinical and historical, that point towards a potential reunion this time around.

Last week a virtually unknown author named Brian Murarseku appeared on the Joe Rogan Experience and I can’t stress this enough…. it blew my mind.

The Immortality Key is Muraresku’s first book. With it, he assumes the role of torchbearer for the rigorous study of the role of psychedelics in the Greek and Roman empires and primitive Christianity, carrying on the work of luminaries like Gordon Wasson, Aldous Huxley, and others.

The Immortality Key is like The Road to Eleusis, The Doors of Perception, and The Da Vinci Code wrapped into one.

Offering the latest archeological and classical scholarship with a swift-moving plot, it is accessible reading on a topic with implications that would, to use a cliched phrase, "shake the Roman Catholic Church to its core” and fundamentally change long agreed upon historical narrative.

Muraresku lays out evidence that the original Christian Eucharist might very well have been a psychedelic wine. Of course, the early Church would have viewed such a sacrament as a threat and would have stomped out the pre-Christian ritual leaving little to no evidence.

I am not one for hyperbole, but if the advent of psychedelic-assisted therapy isn’t a watershed moment in human history, the simultaneous emergence of psychedelic medicine and entheogenic-assisted religiosity certainly is.

Along those lines, Johns Hopkins Magazine recently resurfaced findings from a DMT survey study, noting that:

“The vast majority of the respondents said DMT brought them into contact with a "conscious, intelligent, benevolent, and sacred entity," most commonly described as a "being" or "guide," in an interaction that oozed joy, trust, love, and kindness. Eighty percent reported that the experience had fundamentally altered their perception of reality, and 72% said that the entity continued to exist after the experience "in a different plane of reality." Perhaps most startling was that more than half of those who had previously self-identified as atheists—28% of the sample—described some type of belief in a higher power or God after taking DMT, according to Griffiths, director of the Johns Hopkins Center for Psychedelic and Consciousness Research.”

You expect Blue Cross Blue Shield to cover this?

Speaking of insurance coverage, MAPS just published findings that MDMA-Assisted Psychotherapy Will Be More Cost-Effective than Other Treatments for PTSD.

“A peer-reviewed study published today in the research journal PLOS ONE demonstrates that MDMA-assisted psychotherapy is remarkably cost-effective when compared to currently available treatments for posttraumatic stress disorder (PTSD). It is estimated that a public healthcare payer or private insurer making MDMA-assisted psychotherapy available to 1,000 patients with PTSD would reduce general and mental health care costs by $103.2 million over 30 years.”

And if the entanglement between the modern healthcare system, Mystical Experience-as-Mechanism-of-Action, and the history of the Abrahamic Religions wasn’t enough, we have to deal with the political implications of psychedelic medicine.

Eddie Jacobs, the Oxford bioethicist in training made the case in Scientific American that the ethical implications of psychedelic-assisted therapies are far from straightforward because of the apparent “liberalizing” qualities (emphasis mine):

“Arguably, then, it is unsurprising that it can generate long-lasting changes in patients: studies report increased prosociality and aesthetic appreciation, plus robust shifts in personality, values and attitudes to life, even leading some atheists to find God. What’s more, these experiences appear to be a feature, rather than a bug, of psilocybin-assisted psychotherapy, with the intensity of the mystical experience correlating with the extent of clinical benefit….

But to generate a breadth of appeal, one challenge stands out: psilocybin seems to make people more liberal.”

Eddie has been preparing for the dissertation process and peer review with an active Twitter presence, where What if a Pill Can Change Your Politics or Religious Beliefs? received some good-natured “real world peer-review.”

Business Headlines

Numinus Appoints Multidisciplinary Global Leaders to its General Advisory Council

“Drawing on experience across a broad range of specialties including psychedelic medicine, mental health advocacy, performance optimization, and digital healthcare, the multidisciplinary council will provide unique insight and guidance to support Numinus' mission of creating an ecosystem of health solutions centered on safe, evidence-based, accessible psychedelic-assisted psychotherapy.”

Field Trip Adds Acclaimed Physician, Dr. Andrew Weil, to Medical Advisory Board

“Field Trip Health… today announced the addition of Andrew Weil, M.D., world-renowned leader and pioneer in the field of integrative medicine, to its medical advisory board. In this role, Dr. Weil will provide Field Trip with medical advice and expertise on healing-oriented approaches to healthcare, as well as guidance on extending the influence and reach of psychedelic therapies.” 

Havn Life Applies for Licence to Produce and Sell Psilocybin

“Havn Life Sciences…is pleased to announce it has submitted an application to Health Canada to obtain a Controlled Drugs and Substances Dealer's Licence ("Licence") for Psilocybin and Psilocin.

This Licence, when issued, will permit Havn Life to sell naturally-derived psilocybe spp compounds, under the Controlled Drug and Substances Act, to universities, researchers and companies.”


Thanks for reading and see you next time.

Zach

Loading more posts…