How to Change Your Culture & Ketamine in the Coal Mine Revisited
Today, we’re looking at:
The impact of Michael Pollan’s How to Change Your Mind (HTCYM) and the forthcoming Netflix Docuseries.
We’ll also revisit the story of Cerebral, the Direct-to-Consumer (DTC) Mental health startup, and how it might impact the practice of at-home ketamine operations.
How to Change Your Culture
I hypothesized that the period between August 2017 and December 2019 was a critical incubation period in which seminal regulatory, scientific and cultural eventsgalvanized sufficient mainstream interest to launch ‘psychedelics-the-industry’ into orbit.
The gravitational pull of any persisting stigma was insufficient, and the culture was on its way to a new epoch in psychedelic science, culture, and therapy.
Chief among these seminal events was Michael Pollan’s NY Times Bestseller How to Change Your Mind (HTCYM).
As evidenced by Google Search Trends, since May 2018, when the book was published, the search volume for “psychedelic therapy” has steadily climbed:
Now, the cultural impact of HTCYM is about to go to eleven with the Netflix docu-series:
From the Netflix Media Center:
“Academy Award-winning filmmaker Alex Gibney and New York Times best-selling author Michael Pollan present this documentary series event in four parts, each focused on a different mind-altering substance: LSD, psilocybin, MDMA, and mescaline. With Pollan as our guide, we journey to the frontiers of the new psychedelic renaissance – and look back at almost-forgotten historical context – to explore the potential of these substances to heal and change minds as well as culture. How to Change Your Mind is directed by Emmy-nominated filmmaker Alison Ellwood and two-time Academy Award-nominated and Emmy-winning filmmaker Lucy Walker.”
If the impact of HTCYM on the culture was a museum dose, the Netflix series will be heroic.
It will spread the psychedelic gospel to everyone who no longer reads books and prompt a further move away from “psychedelics are for hippy burnouts” to “psychedelics seem to have therapeutic, spiritual and ontologicalvalue.”
Furthermore, reading is a solitary act, but Netflix is a social medium. People watch Netflix together, so if one partner is intrigued but the other is not, Netflix is a window to modify perceptions in a way that a book is not.
So, while HTCYM the book will have inspired conversations, interest, and media attention, the shared experience of meeting the characters on the screen and following the story of the psychedelic revival with others will do much more to change the narrative than the book.
In the long run, I suspect this will re-galvanize interest, philanthropy, and capital. More so, I bet it will even impact regulators at institutions that stimy research funding and perpetuate politically motivated drug policy. One can wish.
In the short term, the increased attention on psychedelics will promote psychedelic use and highlights the need for education, skilled facilitators, and safe and responsible venues. Hopefully, this film will continue to encourage thoughtful, high-quality entrepreneurs to enter the space.
On the other hand, it will also make interpreting the science more tricky.
So allow me to hop onto one of my favorite hobby horses: Real-World Research.
Working with Great Expectations
In Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials Jacob Aday and colleagues note:
“psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants’ expectations for treatment benefit…”
As we covered in Great Expectations:
Regular Trip Report readers may be rolling their eyes at yet another invocation of real-world research and the role of technology in psychedelic science and clinical practice, but here we are. It’s in my nature.
The proliferation of psychedelic use, the advent of Regulated Use frameworks (i.e., Oregon), the rise of retreats and clinics, and the adoption of digital health technology are aligning to make naturalistic/real-world research an increasingly compelling research format. Therefore, our understanding can come from real-world clinics, retreats, and even personal use scenarios, not just laboratories.
It is exciting to see what comes of this evolution of Michael Pollan’s impact on both the culture and research.
Hopefully, with this increased interest and adoption coupled with technology to support data collection, we can usher in a new era of psychological and salutogenic research.
DTC Ketamine in the Coal Mine
Cerebral is probably the largest virtual care startup that prescribes controlled substances without in-person visits.
They don’t work with ketamine, but if ketamine is the canary in the coal mine of psychedelic medicine, Cerebral may be a canary in the coal mine for Direct-to-Consumer (DTC) ketamine.
Founded in January 2020, Cerebral grew to an incredible $4.8 Billion valuation in less than two years with the rapid adoption of telehealth services in the wake of Covid lockdowns, a loosening of telehealth-prescribing restrictions, aggressive marketing, and of course, universal despair.
But since May this year, they have been the subject of intense media and regulator investigation.
At the time, the scrutiny of online prescribing practices of controlled substances like Xanax, Adderall, and Ritalin was just beginning as Cerebral announced it was under investigation by the Department of Justice.
Since then, pharmacies stopped filling prescriptions written by Cerebral, the CEO stepped down, and the Federal Trade Commission launched an investigation into the company’s business practices.
This week, further reporting from Fierce Biotech suggests that other telehealth startups will be facing similar scrutiny (emphasis added):
“Even prior to the COVID-19 pandemic, the Department of Justice (DOJ) was ramping up its focus on telehealth companies and prescribing practices for controlled substances…
Cerebral is currently mired in a DOJ investigation into its prescribing practices and “possible violations” of the Controlled Substances Act. Last month, Cerebral Medical Group received a grand jury subpoena from the U.S. Attorney’s Office for the Eastern District of New York…
“I think we're going to see a lot of activity in the space,” Miranda Hooker, a partner in the health sciences department at law firm Troutman Pepper, told Fierce Healthcare. “I think we're going to see an increase in a lot of investigations and inquiries into services that are being provided via telehealth, including the prescription of controlled substances.”
Does Cerebral Ruin the opportunity for everyone?
Virtual prescribing of controlled substances like Adderal and Ketamine comes from emergency legislation during the Covid pandemic.
Lockdowns in the early days of the pandemic prompted the DEA to waive the requirement for an initial in-person visit:
"for the duration of the public health emergency, a practitioner may prescribe a controlled substance to a new patient via telemedicine—using a real-time, two-way, interactive audio-visual communication—without first conducting an in-person examination."
The DEA may decide the public health emergency is over and lifts the waivers that allowed this model.
Even if the waivers continue, Cerebral looks to be the poster child against wanton virtual prescribing of controlled substances, and restrictions and oversight will become more ubiquitous.
Relatedly, a lively discussion about ketamine happened over on LinkedIn that is worth checking out.
Further Developments & Reading
Chacruna: Decriminalize Nature Targets Peyote: Drug Reform or Settler Colonialism?
“When these general developments are paired with the realities of a draconian drug war that seeks to punish and control, rather than support and assist individuals and communities in need, steps to decriminalize these substances and de-escalate the War on Drugs appear quite rational and important. The history and present sociocultural context of the peyote cactus within the United States, however, sets it apart from other, similar substances.”
Entrepreneur: The Burgeoning Psychedelics Industry Is Full of Money and Good Intentions. But Can It Avoid All Of Cannabis's Mistakes?
“The challenge to launching in a new space is you might have some strong feelings about how things should be," says Rory McDonald, Ph.D., an associate professor of business administration at Harvard Business School. "But in a new space, that 'should' can quickly change: All it takes is one person or organization to do things differently and have success, and it can redefine the terms for everyone else.”
CaaMTech x Alexander Shulgin Research Institute
“Dr. Shulgin was able to design, synthesize, and test hundreds of compounds in his lab in Lafayette, California, but he did not have the benefit of modern equipment, such as X-ray diffractometers. Since that time, X-ray crystallography has become the gold standard of chemical characterization.”
Forbes: Psychedelics May Be Your Ticket To Self-Actualization, Says New Research
“Self-actualization refers to the process of realizing one’s full potential while retaining the ability to appreciate and enjoy life to its fullest. It is a state of mind that everyone strives for but not everyone achieves…
Interestingly, new research in the field of psychedelics has begun to highlight how psychedelic use could propel you towards self-actualization. Here’s how.”
Thanks for reading, and have a great weekend!
In chronological order:
August 2017—MAPS’ Breakthrough Therapy Designation for MAT for PTSD
May 2018—Publication of Michael Pollan’s How to Change Your Mind
October 2018—Compass Pathway’s Breakthrough Therapy Designation for Psilocybin for TRD
March 2019—FDA Approval of Spravato (esketamine)
April 2019—First University Psychedelic Research Center at Imperial College London
May 2019—Denver’s Decriminalization of Psychedelic Mushrooms by Ballot Initiative
June 2019 —Oakland Decriminalizes Psychedelics by City Council Resolution
September 2019— Launch of John’s Hopkins Psychedelic and Consciousness Research Center
November 2019—Usona Institute’s Breakthrough Therapy Designation for Psilocybin for MDD
better than a mycelium analogy 🤷
People who read books don’t even know what ontological means, and neither do I
Netflix and Chill