Elon Musk Promotes Psychedelics; Italy Schedules Ayahuasca; DTC Controlled Substances Under Scrutiny by DEA
Elon Musk Promotes Psychedelics; Italy Schedules Ayahuasca; DTC Controlled Substances Under Scrutiny by DEA
Before we dive in, a quick note on the format of this newsletter.
I am still figuring out how to approach these end-of-the-week dispatches.
Is it a news round-up? Is it a weekly column?
Ideally, it is both.
Here’s what I aspire to—identify the themes and narratives in the week’s developments and connect them to the long-term trends and dynamics that are shaping this emerging space.
For example, this week, I learned of Italy’s recent scheduling of Ayahuasca.
Italy had been considered hospitable to the religious and ceremonial use of Ayahuasca and a potential destination for psychedelic retreat operators.
So this decision will affect retreat companies and religious organizations, but more broadly, what does this decision—seemingly out of the blue—say about the appetite for the increasing use of psychedelics by federal governments worldwide?
Should we consider this move, along with the DEA’s recently announced plans to schedule DOC, DOI, and five other tryptamines, as indicators of a broader trend among national governments’ unease with the psychedelic movement?
Do these developments mean the perception that The War on Drugs is ending is in fact a hallucination?
In today's dispatch, we’ll look at this in more detail, as well as:
Elon Musk’s advocacy for psychedelics
The DEA’s investigation of Cerebral, the Direct-to-Consumer mental health startup—and what it could mean for ketamine purveyors
A crowdfunded brain imaging study of DMT and other news
And if you have thoughts, opinions, feedback, or ideas, please hit respond and let me know what works, what doesn’t and what you would like to see in these dispatches.
On to The Trip Report.
Elon Musk Supports Psychedelic Medicine
In case you’ve been living under a rock, Elon Musk has been even more in the spotlight lately for his acquisition of Twitter.
If he wasn’t the most adored and loathed figure on the planet before this purchase, he certainly is now.
Not long after the announcement of the takeover—and entirely unrelated— he advocated for psychedelics by tweeting:
“I’ve talked to many more people who were helped by psychedelics & ketamine than SSRIs & amphetamines”
I captured a screenshot of the thread that includes Musk’s comment as it captures the state of the psychedelic narrative arc remarkably well:
Psychedelics pointed to as innovative mental health treatment
Psychedelics invoked as cultural and social change agents
The idea is amplified by celebrity/media support—in this case, the global celebrity
A cautious party concerned with the overexuberance challenges the premise
Several weeks ago, I posited that the psychedelic industry was squarely in the trough of disillusionment as matters of sexual abuse in psychedelic clinical trials surfaced, company stocks had bottomed out, and recent clinical trial results did not meet lofty expectations.
While I think this holds true for those of us paying close attention and working in this emerging space (and is further evidenced by the difficulty in interpreting recent scientific findings). However, as far as the general public is concerned, it is still early days in the adoption of psychedelics.
That’s what makes this field so incredibly fascinating—there is no precedent, in my opinion.
Any novel technology or innovation that has meaningfully shaped society—the automobile, the telephone, the internet, sanitation, antibiotics, birth control—were all introduced as new categories that had to be adopted through commercialization or government adoption.
While many companies, organizations, and political movements seek to introduce psychedelics through legally tenable means, an underground or black market of psychedelics has been around forever. It will continue to provide the on-ramp for many people over the next several years as clinical trials and policy reform efforts establish legal access in healthcare systems and local jurisdictions.
Proselytizing by the world’s wealthiest and most influential person will go a long way to accelerating this adoption.
Hopefully, the most entertaining outcome is the most likely.
Federal Unease About Psychedelics?
During panel discussions at psychedelic conferences, podcasts, and webinars, the common question is, “how does this get shut down?”
“This,” of course, is the emerging psychedelic ‘renaissance’—the fragmented assortment of political and social movements, areas of scientific research business strategies that all share psychedelics as the common ingredient.
And the prospect of a “shut down” hearkens back to 1970 when Richard Nixon launched The War on Drugs with the Controlled Substances Act, making psychedelics and other drugs illegal—in response to the ‘drug-fuelled counterculture movement.’
This federal regulation and increasing pharmaceutical regulation put an end to the promising, albeit flawed1, clinical research into the therapeutic use of psychedelics for mental health conditions.
Two items came across the newswire this week that are relevant to thinking about how ‘this could all get shut down’:
As discussed above, Italy’s unanticipated scheduling of Ayahuasca
and
The DEA’s Investigation of Cerebral, a Direct-to-Consumer prescriber of prescription mental health drugs, including Adderal and other controlled substances
I wouldn’t say these are harbingers of a dramatic halting to what is a ‘train that has left the station,’ but they do point to the ever-present challenges of
Introducing psychedelics into the culture under outdated and politically motivated prohibitionist drug policies and
Introducing psychedelics into pharmaceutical-first, fee-for-service-healthcare systems.
Both are examples of federal governments shortening the leash in response to perceived and actual risk.
Italy Schedules Ayahuasca
From ICEERS, which reported the details of Italy’s decision to schedule Ayahuasca (emphasis added):
“In March 2022, the Italian government made Banisteriopsis caapi and Psychotria viridis, the two principal ingredients of the Amazonian brew ayahuasca, Schedule I controlled substances. In addition, components of these plants (harmine and harmaline from B. caapi and DMT from P. viridis) are now controlled as well. Schedule I is a category created by the International Convention on Psychotropic Substances of 1971 that includes components declared to have “no medical or scientific use” and pose a “high risk for public health…
This motion put forth by Health Minister Roberto Speranza was not anticipated, particularly since in 2009 the Cassation Court had ruled that ayahuasca was not illegal. The reason given for the policy change was that ayahuasca (as well as three of its components) presents “risks to public health.”
This move by Italy follows the US Drug Enforcement Agency’s recently announced intention to schedule several tryptamines and the psilocybin analogs DOC and DOI, commonly used in basic research.
You have to ask, “how do such strategies persist when the scientific case for the therapeutic potential and non-toxic and non-addictive properties of psychedelics builds strength while at the same time the scientific rationale for prohibition-based drug policy is falling apart?”
I think back to a conversation I once had with a federal agent who enlightened me on the incentives at play. Agencies like the FBI and DEA are dependent upon the drug trade. Therefore, office budgets, careers, and livelihoods, depend on fighting illegal drug trafficking.
Despite growing interest and efforts to reform local drug policy, the field could be reduced to medical psychedelics and illegal operations if the federal government isn't going to play ball.
I can't help but think of the Terrence Mckenna quote:
“Psychedelics are illegal not because a loving government is concerned that you may jump out of a third story window. Psychedelics are illegal because they dissolve opinion structures and culturally laid down models of behaviour and information processing. They open you up to the possibility that everything you know is wrong.”
Cerebral Halts DTC prescribing of Adderal and Faces Investigation by DEA
Relatedly, the DEA is investigating Cerebral, the $4.8 billion Direct-to-Consumer mental health start-up causing them to halt online prescriptions of controlled substances like Adderall and Xanax for ADHD, depression, and anxiety.
From Fierce Biotech:
“Cerebral will stop writing prescriptions for Adderall, Ritalin and other controlled substances to new ADHD patients as concerns grow about telehealth companies' prescribing practices.
The well-funded online mental health startup has faced increased scrutiny from the media and former employees about its prescribing practices. Complaints have surfaced that the company has been too quick to prescribe powerful stimulant drugs.
The problems at Cerebral intensified Wednesday as Insider reported that the Drug Enforcement Agency (DEA) is investigating the company. U.S. DEA agents interviewed former Cerebral employees about issues with clinician licensing and about allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported, citing sources.”
What does this have to do with psychedelics?
At the moment, the psychedelic industry is the ketamine industry.
With the exception of international retreats, illegal ceremonies, and local networks of growers and dealers, ketamine clinics and online ketamine prescribers are the primary revenue-generating businesses in psychedelics.
The online prescribers of ketamine are reliant on the suspension of the Ryan Haight Act, which we covered several weeks ago:
“Several Direct-to-Patient Ketamine startups are possible because of covid-era changes to legislation that previously prevented online prescribing of controlled substances.
Until the Covid pandemic, doctors had to conduct in-person evaluations to prescribe scheduled substances like Buprenorphine for opioid use disorder and ketamine for depression.
In March 2020, this restriction was temporarily lifted under an emergency authorization—now, stakeholders are trying to make these changes permanent.
The in-person requirement was part of The Ryan Haight Online Pharmacy Consumer Protection Act of 2008. It was meant to regulate the then-nascent practice of prescribing controlled substances through telemedicine, specifically to prevent the diversion to illegal markets.
However, lockdowns in the early days of the pandemic prompted the DEA to waive the requirement for an initial in-person visit, thereby allowing patients to receive controlled substances through telemedicine.”
I get the sense scent that Cerebral is in hot water because of a ‘growth at all costs’ mentality, and in healthcare startups, when patient well-being is secondary to growth, it will eventually catch up to you.
The demand for DTC ketamine that lets people trip in the comfort of their own home or with their own therapist rather than a ketamine clinic appears to be robust.
So, will we see the DEA investigate DTC online ketamine prescribers? Eventually.
Other News & Further Reading
Right to Try March
National Mobilization and Call for Civil Disobedience on Behalf of Terminally Ill and Others Facing Life-Threatening Conditions
"Passed by Congress and signed by former President Trump in 2018, the Right to Try Act affords those with life-threatening conditions the right to use experimental drugs as long as the drug has completed at least one clinical trial and remains under investigation...
But the DEA has prevented terminally-ill patients from receiving the drug [Psilocybin] for nearly two years by incorrectly citing the Controlled Substances Act and psilocybin’s status as a Schedule I drug.
WHEN: Monday, May 9th, 12:00pm ET
WHERE: DEA Headquarters, 700 Army Navy Dr., Arlington, VA 22202
Public Funding to Increase Access to Psilocybin: Barriers & Possible Solutions
“This blog post addresses how continued federal prohibition limits the accessibly of psilocybin services under Measure 109, and proposes several funding sources the state of Oregon could tap into to increase access.”
Compass Presents Data on Anorexia Nervosa:
“30% (n=3) of participants experienced clinically significant reductions in eating disorder psychopathology at the 1-month follow up, and 40% (n=4) experienced clinically significant reductions at the 3-month follow-up. Participants demonstrated statistically significant reductions in shape concerns at the 1-month follow-up (p<.05), and statistically significant reductions in eating concerns at the 3-month follow-up (p<.05).”
Do psychedelics change beliefs?
“Rather than inducing de novo beliefs, we argue psychedelics may instead change the impact of affect and of others’ suggestions on how beliefs are imputed. Critically, we find that baseline beliefs (in the possible effects of psychedelics, for example) might color the acute effects of psychedelics as well as longer-term changes.”
Connecticut Advances Psychedelic Treatment Bill
“Connecticut lawmakers sent the governor a large-scale budget bill on Tuesday that includes provisions to set the state up to provide certain patients with access to psychedelic-assisted treatment using substances like MDMA and psilocybin…
While the legislation would not legalize the psychedelics, it would set up a regulatory infrastructure to enable Connecticut to play a leading role in providing access to this alternative treatment option as federal agencies continue to fund and facilitate clinical trials.
Psychedelic therapy would be specifically provided and funded for military veterans, retired first responders and health care workers under the budget measure.”
That’s it for this week. Thanks for reading!
Zach
Will we ever see psychedelic research that isn’t flawed?