You are currently viewing Psychedelic Bulletin #140: Regulators Weigh in on Psychedelics; Psychedelic Biotech Strikes Big Pharma Agreement; GH Publishes 5-MeO-DMT Trial

Psychedelic Bulletin #140: Regulators Weigh in on Psychedelics; Psychedelic Biotech Strikes Big Pharma Agreement; GH Publishes 5-MeO-DMT Trial

This Week:

  • ✒️ Regulators Weigh in on Psychedleics (FDA, UN, EU)
  • 🌏 Psylo Strikes Agreement with Japanese Pharma Co.
  • 🥼 GH Research 5-MeO-DMT Trial Published
  • 🌍 Our New Worldwide Psychedelic Laws Tracker

and lots more…

Psychedelic Sector News

Regulators Weigh in on Psychedelics (FDA, UN, EU)

Regulators are increasingly paying attention to interest in psychedelics: both medical and beyond. In the past couple of weeks national regulators like FDA as well as supranational groups like the UN and EU have published guidance or commentary on this class of substances.

UN World Drug Report 2023 Covers ‘Recent Developments Involving Psychedelics’

As part of its annual World Drug Report the United Nations Office on Drugs and Crime (UNODC) supplements its data dump with a more narrative-led booklet on Contemporary Issues on Drugs. This year, the second of the eight topics included in this booklet was titled, Recent Developments Involving Psychedelics.

The fourteen-page booklet begins by describing ‘renewed interest’ in the therapeutic use of some psychedelics, psychedelic tourism, and “self-therapy” with psychedelics; while acknowledging longer-standing indigenous and spiritual uses.

On the topic of regulatory developments, the booklet features our U.S. decriminalisation and legalisation map (regrettably, the publication of our worldwide psychedelic laws map just missed the deadline)

If this author was being pedantic, they might be tempted to point out errors or sloppiness in this piece, which include…

  • “In short, it is not the substances alone but their combination with the broader sequence of psychotherapy with trained psychiatrists and psychotherapists that ensures the therapeutic benefit.” While this is almost received wisdom among many in the psychedelics space, it has not been borne out in research just yet. Indeed, as the FDA’s draft guidance notes, “the contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized”.
  • Claims that several states in the U.S. have “begun approving psychedelic therapies for a range of conditions” conflate therapy with the licensed facilitation of non-medical services as seen in Oregon and (soon) Colorado. These contexts are again conflated later when they’re referred to as “medically supervised use”.
  • The fact that a “bad trip” is discussed as a potential adverse outcome of microdosing is odd, given that microdoses tend to be sub-perceptual. Meanwhile, the potential risks of chronic 5-HT2B agonism isn’t discussed at all.

But, overall, this is a largely informative piece for the average reader which does a good job of capturing growing levels of interest in psychedelics from researchers and users alike.

It’s also helpful in outlining the central concern of many regulators: the ‘risk’ that non-medical use outpaces, or proves more accessible than, offerings that are the product of clinical trials and medical research. Of course, the most consequential element is whether, or how, regulators choose to react to this perceived risk.


European Drug Report Briefly Discusses Psychedelics

In a similar spirit, the European Monitoring Centre for Drugs and Drug Addiction’s (EMCDDA) European Drug Report also covered psychedelics, choosing to focus on the “possible adverse consequences of growing interest in the therapeutic potential of psychedelic drugs”.

While the agency acknowledges that “some research appears promising”, it warns that the considerable media attention afforded to these studies “may encourage greater experimental use of these substances without medical support, potentially putting some vulnerable individuals at risk of suffering adverse consequences.” The report also mentions evidence of ‘unregulated programmes’ being operated in the EU, alluding to retreats.


FDA Issues Draft Guidance on Psychedelic Trials

Last Friday the FDA issued its first draft guidance on clinical trials with psychedelic drugs. The 14-page document presents non-binding guidance, or “considerations”, that psychedelic drug developers would be wise to heed.

Interestingly, unlike UNODC, FDA doesn’t include dissociative anaesthetics like ketamine in its definition of ‘psychedelics’, perhaps due to the fact that ketamine is already FDA approved.

One element of the guidance has caused a stir among psychedelic researchers and practitioners:

“The therapist monitoring the session can usually deduce the treatment assignment by observing the subject’s behavior. Therefore, it is preferable that the in-session monitor is not involved in post-session psychotherapy because their knowledge of the treatment could bias the delivery of subsequent therapy.”

This suggestion, the FDA thinks, might help reduce bias in assessing efficacy. But it flies in the face of received wisdom among many psychedelic therapists (and non-psychedelic therapists, for that matter).

We covered this topic in much more detail back in March, when FDA’s Tiffany Farchione addressed participants at ECNP in France and mentioned this potential guidance. While it wasn’t a significant portion of her presentation, it piqued this author’s interest:

Where Regulators and Researchers Disagree

One of the points raised by FDA’s Farchione got me thinking. As aforementioned, Farchione suggested that sponsors might reduce potential biases by having post-treatment therapy conducted by a different person than the in-session monitor.

This approach struck me as out of kilter with what a number of researchers had mentioned throughout the meeting, prior to Farchione’s presentation.

Gerhard Gründer, who leads a psilocybin for depression study funded by the German government (see our November 2020 coverage), believes that “if you administer a psychedelic there’s a special relationship between the therapist and the patient”. Gründer shared emails from two patients in his trial to illustrate his point, with one patient writing: “I am infinitely grateful to you, […] I cherish you in deep friendship, not as therapists but as people.”

The most important factor in the efficacy of psychotherapy is the alliance between patient and therapist(s), he said, adding that “we may lose efficacy” if we separate the therapists who psychologically support the administration of psychedelics from “true psychotherapists.” Gründer was emphatic: this alliance “cannot be delegated for a couple of days to someone to administer the drug”.

Elsewhere, during a question and answer period, David Erritzoe discussed how the responsibility of the therapist in managing the very difficult (and sometimes possibly false, dream-like) material that may emerge during a psychedelic session is “immense”, “massive”.

Upon hearing the FDA’s proposal of having a different person conduct the post-drug integration sessions, I wondered how this might work given Erritzoe’s experiences. How might a therapist who did not witness the psychedelic session take on this “immense” task?

Perhaps this is why psychedelic drug developers and researchers alike have not adopted this element in their study designs.

This mismatch between FDA advice and our current (presumed) ‘best practice’ of psychedelic therapy perhaps points to a larger piece of context that is always worth remembering: the FDA does not regulate psychotherapy. Given this fact, it’s not surprising (or sinister) that the agency is looking to disaggregate the drug effect from the psychotherapy, or psychological support.

It does continue to generate friction and challenges, though, for psychedelic drug developers who walk a fine line between satisfying the FDA that they have taken adequate steps to reduce bias and provide a valid comparison to something, and maintaining key elements of psychedelic-assisted therapy that are presumed to drive its safety and efficacy.

Gründer’s advice (or, plea) to regulators: “Don’t just look at curves. Listen to the patients and to the therapists!”

A 60-day public comment period is now underway, meaning you can take umbrage to this suggestion—and any of the others—via the Federal Register.


Elsewhere, the Royal Australian & New Zealand College of Psychiatrists (RANZCP) released a Clinical Memorandum on the therapeutic use of psychedelics this month, ahead of the limited rescheduling of psilocybin- and MDMA-assisted therapy in Australia next week.

Psylo Strikes Agreement with Japanese Pharma Co.

Psychedelic biotech Psylo has entered into a sponsored research agreement with Japanese pharma company Daiichi Sankyo, which it hopes will help drive the development of its non-hallucinogenic psychiatric drugs. The Sydney-based startup will set-up an office at a science incubation facility in Philadelphia, B+labs.

Daiichi Sankyo is firmly in the realm of big pharma, with a market cap of around $60bn. While its key products are in cardiovascular and oncology, the company has identified psychiatric diseases including major depressive disorder (MDD) and anxiety disorder among its areas of interest.

This isn’t the first time a Japanese pharmaceutical company has partnered with a psychedelic drug developer. Readers might remember that, as part of our 2022 Year in Review, we reviewed Otsuka’s interest in psychedelics.

GH Research 5-MeO-DMT Trial Published

It’s a small trial, with a total cohort of 16 patients, but the top-level results are positive with the inhaled 5-MeO-DMT well tolerated and delivering rapid antidepressant effects. Seven out of eight participants in the individualised dosing regime cohort were in remission at day 7 (Reckweg et al., 2023).

Given the short follow-up period durability of effects is unclear. But if GH is able to come close to reproducing this efficacy in larger cohorts, this could be a goer even without medium- or long-term durability. In that case, it might target a similar product profile as Spravato, with similarly rapid but potentially more potent antidepressant effects.

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Miscellaneous News

Misc. Psychedelic Science 2023 Coverage

We’re still getting back to our usual cadence following PS23 in Denver last week. Here’s some coverage of the event:

  • Daily coverage from The Microdose, UC Berkeley’s fantastic psychedelics newsletter
  • Lucid News also provided daily dispatches
  • Vox: The largest psychedelic conference in history is surprisingly sane
  • Axios: Massive psychedelics conference in Denver draws celebrities, politicians and more
  • NBC News: Aaron Rodgers speaks about psychedelics and how they ‘unlocked that whole world’ for him (note: many other outlets covered this.)
  • NPR: Denver psychedelics conference attracts thousands
  • Colorado Public Radio: ‘Psychedelics is about healing’: Thousands gather in Denver for largest psychedelic conference to date
  • ABC Denver: Moms on Mushrooms organization attend Psychedelic Science Conference in Denver
  • NewScientist: Religious leaders given psilocybin say they “felt God”
  • Bloomberg: Largest Psychedelics Gathering Shows Industry’s Ongoing Struggle

Misc. Media Coverage

AP: Biden’s brother says the president is ‘very open-minded’ about psychedelics for medical treatment

WSJ: Ecstasy-for-Medicine Advocate MAPS Looks for Cash Lifeline

STAT: Counter-culture or pharma: Group behind MDMA therapy for PTSD wrestles with its identity

WSJ: As Psychedelics Become More Mainstream, Here’s What You Need to Know

Independent: Jaden Smith says his mother Jada Pinkett Smith introduced family to psychedelics

Rolling Stone: The Battle for the Future of Psychedelics

OPB: Portland rabbi explores connection between Judaism and psychedelics

POLITICO: Psychedelics oversight just got stricter (note: misleading title; this is coverage of the FDA draft guidance discussed earlier.) Research on Psychedelics, Marijuana as Alternative Treatment for Vets Advancing in Congress

WaPo: Microdosing psychedelics has benefits, users say. Science isn’t convinced.

Wired: Meet the Psychedelic Boom’s First Responders

New: Worldwide Psychedelic Laws Tracker

Starting with the 1961 UN Single Convention on Narcotic Drugs, and followed by the 1971 UN Convention on Psychotropic Substances and the 1988 UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, international barriers to national-level drug policy reform were raised higher and higher. In recent years however, this UN drug control system has started to crumble in response to changing social and political views, starting with the legalisation of cannabis in several countries, and the removal of criminal sanctions for drug use in others. More and more countries are now reforming their drug laws, and the UN Chief Executives Board, which represents the heads of 31 UN agencies, has called for the “decriminalization of drug possession for personal use” and “changes in laws, policies and practices that threaten the health and human rights of people”.

In our latest resource, we track these changes and the status of drug policy reform efforts across the globe, with a focus on psychedelics. The precise effect of these changes are varied: some involve decriminalizing possession and personal use of psychedelics (such as in Portugal), others allowing access to psychedelics for medicinal uses (such as in Canada), while a few are legalizing possession, use, cultivation and sale of specific psychedelics (such as in Jamaica).

An important note—we’re neither lawyers nor residents in these countries, and our information is only as good as our interpretation of the materials we reviewed. If you believe or know otherwise for any jurisdiction, we invite you to reach out to us at To read more about the history of psychedelic use, and how it has been impacted by the changes in drug policy, please see our background article.

PSYCH Symposium: Next Thursday

Join us at PSYCH Symposium next Thursday at the British Museum.

Amidst the packed agenda our Editor, Josh Hardman, will be interviewing Christian Angermayer.

Tickets here (Use HARDMAN15 for a discount)

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