Part of our Year in Review series

Having already looked back at your favourite Psychedelic Alpha articles from 2023, I thought I’d offer some broader reflections on the year.

We’re also approaching the fourth birthday of Psychedelic Alpha—which I began back in March 2020 as Psilocybin Alpha. That milestone, which takes place in Spring, will offer a natural moment for a broader reflection on the recent history and trajectory of the space.

For now, I will try to keep my thoughts limited to the year just gone by: 2023.

Josh Hardman
Founder & Editor

Like many things, 2023 simultaneously passed in a flash yet also seems like an era ago. When I looked back through our coverage in preparation for this Year in Review series, I was struck by just how much happened.

To kick off the year, the Windsors’ ugly duckling (Prince Harry) confessed his use of ayahuasca and psilocybin in a 60 Minutes special. Mainstream media were beside themselves, with British press reportedly “in a tizzy” and U.S. outlets like WSJ carrying bizarre stories like this one on the Prince’s “Pagan Progress”. (Harry “seeks enlightenment like a typical millennial”, the tagline reads, “via drugs and meditation.”)

Conservative think tank Heritage Foundation swiftly FOIA’d the Department of Homeland Security, asking it to release Harry’s allegedly fraudulent visa application as pro-monarchy (and thus vehemently anti-‘Haz and M.’) outlets foamed at the mouth.

Harry’s confession appeared to capture a moment among high society. “Everyone seems to be on psychedelics except me”, read the title of a January opinion piece in the posh British broadsheet, The Telegraph.

In terms of more niche ‘industry’ news, on January 5th MAPS announced that its second Phase III study of MDMA-assisted therapy for PTSD was “successful”. While thin on details, the signal allowed a sigh of relief and a building of anticipation for the study’s publication and a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

January also saw Oregon begin accepting licencing applications for the first state-legal psychedelic program in the country. And, state legislatures across the U.S. announced a flurry of new psychedelic policy reforms: from Washington to Connecticut.

Whether you were a psychedelic policy reform advocate, researcher, hopeful service centre operator, Prince Harry basher or industry bod: It looked set to be an absolute belter of a year.

But, that firehose of news swiftly dialled down. Oregon’s licencing floodgates opened to be greeted by a trickle, psychedelics-related bills slogged through a war of attrition, and the reality of FDA approval timelines and roll-out challenges sunk in.

In many ways, as the psychedelics space’s internal hype cycle boiled over in 2021 and early 2022, it returned to a simmer in 2023. But, as I learned in Austin last year, the best brisket is cooked ‘low and slow’.

Moments of Celebration

There were certainly moments of celebration in 2023.

For me, many of the most memorable moments took place at the variety in-person events and meetings I was lucky enough to attend. As the spectre of COVID lifted, the return to in-person events was in full swing.

In March, psychedelics programming took a sizeable chunk of SXSW’s programming, with 2023 marking the first year that it had a dedicated track (“SXSW Is High on Psychedelics”, reads an Austin Chronicle headline looking ahead to 2024’s agenda) and a strong contingent.

Later in March, I headed to Nice in the South of France for the European College of Neuropsychopharmacology’s (ECNP) psychedelics-dedicated New Frontiers meeting. I found this fascinating, as you can read in my Dispatch.

In June, our team had a fantastic time at Psychedelic Science 2023 in Denver, Colorado, where MAPS hosted tens of thousands of people from all corners of the ‘psychedelics space’. (All of the conference’s talks and panels—including my State of the Psychedelic Sector talk—can be viewed, for free, via the Virtual Trip website.)

Other notable mentions include Breaking Convention on home turf in Exeter, UK in April; a visit to Shulgin’s Farm in October; a trip to the European Parliament in November; and, reMind in December.

As the psychedelic-specific conference calendar threatens to have reached peak saturation, perhaps the next stage in the space’s maturity is the infiltration of more mainstream conferences.

We have already seen this in the likes of professional associations and meetings like the American College of Neuropsychopharmacology and the main ECNP conference (where presentations on psychedelics were exceedingly popular), and now we’re seeing it in more popular, sector-agnostic conferences like SXSW.

Aside from the in-person meetings, a real moment of celebration which provided a nice punctuation mark at year-end was MAPS PBC’s (now Lykos) submission of its New Drug Application for MDMA-assisted therapy in the treatment of PTSD, which is the culmination of decades of work and philanthropy.

Regulators and Governments Came to the Table

In 2023, we saw various regulators, professional bodies and agencies come to the proverbial table to discuss psychedelic use, research and potential medical roll-out.

Psychedelics were broached in or by governing bodies across the world: from U.S. federal and state governments through to those in Mexico, the UK, and the EU.

Both the FDA and European Medicines Agency (EMA) issued draft guidelines on psychedelic research this year, the former dropping during MAPS’ Denver conference. In February, members of the EMA’s Central Nervous System Working Party teamed up with ECNP to co-author a Lancet article outlining the ‘European regulatory perspective’ on psychedelics.

In November, the U.S. House Committee on Veterans’ Affairs’ Subcommittee on Health held a hearing titled Emerging Therapies: Breakthroughs in the Battle Against Suicide? The meeting marked the first time the House has substantially discussed psychedelic therapies, a milestone that the Chair, Mariannette Miller-Meeks (R-IA), made sure to highlight in her opening remarks.

The very same month, Canada’s Senate Subcommittee on Veterans Affairs recommended “the immediate implementation of a robust research program funded by VAC and the Department of National Defence (DND) in partnership with Health Canada, the Canadian Institutes of Health Research, and all other relevant partners.”

And, in December, funding for research into the potential of psychedelics in treating PTSD and traumatic brain injury (TBI) in active-duty military made it into the National Defense Authorisation Act, which sets out the U.S. military’s annual budget.

For its part, the U.S. Department of Health and Human Services (HHS) hosted a workshop on the ethical and practical considerations of psychedelics research in September.

The United Nations World Drug Report 2023 featured Recent Developments Involving Psychedelics as one of its eight ‘contemporary issues’. The chapter charts the renewed interest in therapeutic uses of some psychedelics, along with policy developments and commercial interests. (Our U.S. psychedelic laws tracker is featured prominently, too!)

The European Drug Report 2023 also saw psychedelics pulled into focus, with a section on MDMA (largely looking at how product strength remains a concern) and comments relating to psychedelics’ renewed “clinical and public interest”.

But, it wasn’t all rosy. The FDA’s draft guidelines on clinical investigations involving psychedelics struck discord with researchers, in some regards. Elsewhere, the FDA also issued warnings over what it deems the misuse of ketamine¹.

In terms of professional organisations, the American Medical Association approved a trio of CPT III codes for the monitoring of psychedelic treatments in May, a crucial step in the commercialisation of psychedelics. CPT codes are a central part of U.S. medical infrastructure, allowing healthcare practitioners to record and seek reimbursement for the delivery of various services and procedures².

The Royal Australian and New Zealand College of Psychiatrists (RANZCP), meanwhile, emphasised a “safety first” approach to prescribing MDMA and psilocybin in the country. The organisation had been forced into formulating guidelines after the TGA unilaterally rescheduled the two psychedelics—for use in very specific circumstances—in July 2023 (more below). “Put simply, psychedelic-assisted therapy is in its infancy”, RANZCP said in a statement. The professional body had opposed calls to reschedule psilocybin and MDMA.

In the UK, The Royal College of Psychiatrists (RCPsych) signed-on to a letter to the Drugs Minister that called psilocybin’s schedule I designation into question on moral, medical and economic grounds. RCPsych also offers an online learning module on psychedelic therapy. (As far back as the 2018/19 winter edition of its London division’s newsletter, the body was showing interest: the theme was psychedelics in psychiatry.)

The American Psychiatric Association (AMA) did not update its official position that finds the current evidence inadequate to endorse the use of psychedelics and empathogens for mental health, which it adopted in 2022. It did, however, announce a continuing education course on the science of psychedelics and published a podcast episode on the topic.

Legal Markets: From Oregon to Oz

On the policy reform front, we saw a substantial number of psychedelic policy reforms introduced in 2023, at least in the U.S.. While many failed (some due to lack of popular or political support, others due to actions like vetoes), the pace and scale of reforms was remarkable. We will cover this in greater detail in a forthcoming Year in Review section dedicated to 2023’s policy developments.

In terms of ‘legal’ jurisdictions, one highly-anticipated milestone was the advent of the first state-legal, regulated psychedelic services program. As aforementioned, the pace of Oregon’s psilocybin services program’s roll-out has been—somewhat predictably—quite slow.

By year-end, the state had issued licences to 21 service centres, 206 facilitators, 7 manufacturers, and 2 labs. Roll-out has been bottlenecked³ by tight regulations and high licensing fees, though advocates point out that this is the first iteration of an unprecedented program. Disagreements flared over the extent to which participant data should be collected and evaluated, which are likely to continue to cause debate in Oregon as well as Colorado⁴.

Colorado’s Natural Medicine Advisory Board, for that matter, made some progress towards formulating draft recommendations in 2023, though it appears to be bogged down by questions and debates. See our Colorado Natural Medicine Health Act Tracker, which we launched last year with Vicente.

As alluded to above, Australia surprised many by announcing its limited rescheduling of MDMA and psilocybin in early 2023, which was a volte-face from its 2022 decision to not do precisely that. Nevertheless, Australia became the world’s first country to recognise MDMA and psilocybin as prescribable medicines, at least in the Western paradigm of medicine, though real-world impact appears to be limited due to regulatory, logistical and payor barriers.

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Drug Development and Research

On the biotech or pharmaceutical side of the space, the decline in funding appetite and challenging macroeconomic backdrop continued the chill seen in 2022, with very few notable raises last year.

M&A was also slow, though Otsuka scooped up Mindset Pharma, albeit at a modest valuation (See our forthcoming M&A and partnerships section).

And, the shake-out of publicly-listed companies that IPO’d (or, RTO’d in many cases) during the peak of the shroom stocks hype continues, with at least a dozen companies on the brink—or in the throes—of insolvency by 2023’s year end. As with many of the topics mentioned here, we will cover this in more detail in the coming weeks.

We did see long-awaited publications from Usona Institute, which presented data from its Phase IIb study of psilocybin for MDD⁵, and MAPS’ second and final Phase III study⁶.

Elsewhere, we were treated to some major nonclinical studies as the pace of psychedelics-related publications continued to accelerate. Gül Dölen et al.’s critical periods paper sparked conversation around psychedelics’ mechanism of action, disrupting a neuroplasticity-based thesis that was quickly becoming gospel. Also in June, a group of researchers in Finland sparked an intracellular-vs.-extracellular signalling debate after claiming psychedelics promote plasticity by directly binding to TrkB.

Other studies, such as Boris Heifets et al.’s small study of ketamine under anaesthesia, contributed to the gradual chipping away at larger questions such as whether the subjective effects are necessary to the apparent therapeutic benefits of psychedelics; the role of expectancy effects; and so on.

2023 didn’t deliver closure, though, on many of the field’s biggest questions.

The jury is still out, for example, on whether microdosing delivers any efficacy above placebo effects (and whether it has cardiac safety risks); whether non-hallucinogenic psychedelics⁷ will prove efficacious (and, whether they’re even non-hallucinogenic in humans… and, what that even means); the role of psychotherapy in psychedelic-assisted therapies; the optimal number of doses; and so on.

We dive into some of these studies later in our Year in Review, and most of these questions will remain open throughout the year ahead.

Public Perceptions Plateau; Decline?

Despite a splashy start to the year, psychedelics weren’t in the zeitgeist quite as much as they have been in prior years. Or at least, things seem to have plateaued; especially by year-end.

There hasn’t been something comparable to a Nine Perfect Strangers or How to Change Your Mind Netflix series this past year, for example, and public figures like Aaaron Rodgers and Prince Harry appear to be receiving equal parts vitriol as praise for their psychedelic confessionals (Rodgers took top spot in Deadspin’s ‘Idiot of the Year’ charts).

That’s not to say psychedelics didn’t receive airtime: John Oliver’s segment on psychedelic therapy was relatively popular (though was significantly out-viewed by Oliver’s Ron DeSantis segment and on par with his feature on carbon offsets), and psychedelics maintained the attention of mainstream journalists at the likes of the New York Times, the BBC, and so on.

But towards the end of the year, public sentiment took an undoubtedly negative turn.

In October, reports broke that an off-duty pilot had tried to disable the engines on an Alaska Airlines flight. He told authorities that he had ingested psilocybin mushrooms two days prior, and had not slept in forty hours. Some psychedelics advocates (unfortunately, in my opinion) scrambled to dismiss the role of psilocybin in the situation, eager to note that the pilot had ingested mushrooms 48 hours before the incident.

Ryan Munevar, campaign director for Decriminalize California, told POLITICO that the off-duty pilot “couldn’t have been experiencing the effects 48 hours after ingesting the mushrooms”. “It wouldn’t have an impact on him the next day, let alone 48 hours later,” he told the outlet.

The incident was cited by a lawmaker in a VA Subcommittee on Health meeting, as well as by media outlets like the California Globe, where a reporter claimed that “a near hijacking and crash of an Alaskan [sic] Airlines flight late last month by a pilot who had previously taken magic mushrooms put another damper on legalization efforts”, suggesting that this led Senator Scott Wiener to face “even more opposition”.

The challenging news cycle didn’t end there, however. Later in October, a young man was charged with four counts of first-degree murder and one count of attempted murder after he ploughed his truck into a Muslim family in June 2021. Nathaniel Veltman’s lawyers sought to focus on the impact of the three grams of psilocybin he reportedly ingested around 40 hours prior to the attack.

Then, in December, the death of Friends star Matthew Perry, with an autopsy identifying ‘acute effects of ketamine’, ignited similar attempts to explain away the reported role of ketamine in his death.

There’s a delicate balance to be had between avoiding supplying more oxygen to damaging tropes borne of the War on Drugs while not dismissing or explaining away the potential harms (both acute and longer-term) of psychedelics—or those who wish to discuss them. While both are troubling, I am increasingly concerned about the latter.

Speaking of Challenges…

In some of the conversations I had, and events I attended, last year I couldn’t help but sense some unease about some of the tactics used to win bipartisan support for psychedelics.

In the opening of our 2022 Year in Review, Shayla Love described the strange bedfellows that are increasingly occupying the psychedelic mainstream.

The opening ceremony of Psychedelic Science 2023 was arguably a case in point, a spectacle of bipartisanship, with self-described knuckle-dragging Republican Rick Perry and Democrat Governor of Colorado Jared Polis both giving opening remarks.

This present milieu is, at least to some extent, the product of conscious efforts at fostering bipartisan support; which are presumably most focused on picking up champions of the right, given that they have historically (and presently) been most opposed to psychedelics and drug policy reforms more generally.

And this strategy seems to be paying off—at least in a realpolitik sense. When I was taking an elevator to my room in the conference hotel, a retired firefighter and his wife struck up conversation with me. “You’re here for the hippy conference, huh?” he said with a notable hint of derision. When I ran him through the agenda—from Perry to Aaron Rodgers—his tone softened, and his wife reminded him that they had seen an interesting news segment on psychedelics for veterans. And psychedelic organisations have attracted funding from conservative donors.

Be the Bridge is one of MAPS’ 7 Principles⁸, and the effort to make ‘psychedelics’ a broad church certainly extends beyond MAPS. But in 2023 I sensed some people and groups increasingly questioning this strategy. Is it a convenient bridge over the troubled waters of the War on Drugs, or is it a bridge to nowhere?

Some other significant challenges I think were evidenced last year include the aforementioned delicate balance between having sober conversations about the risks and potential damages of psychedelics without playing into prohibitionist tropes; identifying and establishing public funding streams for psychedelic research that are acceptable to voters, legislators and investigators and that don’t cannibalise other deserving projects; preparing for rolling-out and scaling-up psychedelic therapies while acknowledging a chicken-and-egg issue at the heart of that process.

I’m also wondering what came of the ‘reciprocity pledges’ that were often discussed during the peak financial gravity of the space in 2021.

And perhaps the most immediate and existential challenge for many psychedelics companies in 2023 was convincing investors to support them.

Onwards

I’ll save my forward-looking piece for the end of this Year in Review series, but I will share one thing now.

I hope that the baseline, the bare minimum, that we see in the space in the coming years is different constituencies ‘staying in their lane’, so to speak.

My hope is that those pursuing FDA- (and equivalent agency) approval constituents are able to succeed and flourish, reaching patients in need who wish to engage in this pathway, without doing so at the expense of those who wish—or need—to access psychedelics through other pathways (spiritual, ceremonial, decriminalised, etc.).

As these multiple very different routes to psychedelic saliency ramp-up further in 2024—-from the Get Clean for Gene style through to the establish-a-Church model—I hope they will respect the rights of others to pursue a different path; and will do so without infringing on or otherwise jeopardising them. Especially those that have been using psychedelics as part of their religious or spiritual practice for millennia.

For my part, I’m looking forward to getting back to writing more, especially as 2024 promises to be a pivotal year for psychedelics in many respects. With that goal in mind, I was pleased to launch our reader-supported model late last year.

And as things got weird over at Twitter, I was encouraged to create a platform-agnostic home for psychedelics news—a type of aggregator. So we created The Psychedelic News Feed in October and have updated it (almost) every day since.

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At-home ketamine providers and other remote prescribers of scheduled substances didn’t gain the clarity they might have hoped for in a decidedly post-COVID 2023. We had expected to see a permanent solution to the expected end of the Ryan Haight Act waiver, but that didn’t come to pass.
CPT III codes are temporary; designed to allow for data to be collected on emerging technologies, services and procedures. In time, this data might be used to justify CPT I codes, which generally allow for widespread reimbursement consideration by payors.
We expected this, as noted in our 2023 predictions: “The program will get off to a relatively slow start”.
“Given that some see these state psilocybin services models as natural experiments of sorts, discussions over the balance between data privacy on the one hand and the generation of valuable (real-world) safety and efficacy data on the other will continue to be salient”, we wrote in our 2023 predictions.
A couple of months later than we had predicted.
Which was only a quarter behind our prediction from our 2022 Year in Review, as was the NDA submission.
Which remain controversial. Charles Raison, for example, told Nautilus in December: “I personally am greatly hoping that when we remove the conscious experience, that psychedelics will not have the signal.”
MAPS founder, Rick Doblin, has also remarked that his organisation “don’t actually do science, we do political science.”