Australia’s new MDMA and psilocybin prescription program raises concerns for researchers, prompts psychiatrists’ organization to release cautionary memo; psychedelics & U.S. presidential candidates

Plus: Harnessing the placebo effect, and California’s SB 58 amendment follows in the footsteps of Colorado and Oregon

Happy Friday, and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics. 

As Australia’s new psychedelics policy takes effect, researchers and psychiatry professional group voice concerns 

As of July 1, physicians in Australia can apply for a license permitting them to administer MDMA and psilocybin to their clients. The policy change was first announced by the country’s Therapeutic Goods Administration (TGA) in February and it took many researchers and practitioners by surprise. This week, Australian researchers published a paper in the Australian & New Zealand Journal of Psychiatry asking why the TGA did not consult with researchers and clinicians before changing the law. The authors of the paper are running the country’s only active, registered research trial studying the use of psilocybin-assisted psychotherapy to treat major depressive disorder. “It seems the TGA has yielded to pressure from the public and lobby groups to increase access to these experimental treatments, outside of clinical trials,” they write. They point to a lack of “sufficient levels of evidence” for psychedelic therapy; a lack of “universally accepted protocols” for psilocybin-assisted therapy to treat depression; a lack of clarity around who qualifies as an authorized prescriber; and no clear directives on how to support patients who experience adverse effects after psychedelic-assisted therapy. “There are many questions regarding the precise details of this change that remain unanswered. Until these are adequately addressed, we cannot, in good conscience, support this move,” the authors write. “We hope the TGA will consider these issues carefully and seek proper consultation in the coming months as these details are worked out.”

Meanwhile, the Royal Australian & New Zealand College of Psychiatrists (RANZCP), Australia's leading organization for training professional psychiatrists, released a memorandum on the therapeutic use of psychedelic substances which provides information to clinicians interested in prescribing MDMA or psilocybin to patients. (TGA’s licensing rules require all applicants to have completed a fellowship with the RANZCP.) RANZCP’s memo emphasizes that while there is some evidence that psychedelic therapy can help treat mental illnesses, evidence is limited and more research is needed. 

They also highlight potential side effects including bad trips, as well as risks, including the potential link between psychedelic therapy and psychosis in people with a family history of psychosis or mania. RANCZP emphasizes that more data is needed on risks and side effects. Moreover, they point out that patients may already have opinions about what these drugs can do for them. “Taking into account recent media attention highlighting the potential therapeutic benefits of psychedelic substances, broader societal strategies may be required to deter illicit use and self-medication,” the memo reads. RANCZP urges psychiatrists to follow the science, and not the hype. “Community and media interest in psychedelic therapy as a promising therapeutic modality in the face of worsening mental health statistics has led to strong pressure from some advocacy groups to fast-track, or even bypass, clinical research and rapidly implement psychedelic assisted therapy in community settings,” they write. “However, undue haste in translation to community clinics could compromise essential aspects of efficacy, safety and equity, ultimately threatening the sustainability of psychedelic assisted therapy.”

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Snapshots of U.S. presidential candidates’ views on psychedelics

The 2024 U.S. presidential election is still more than a year away, but there’s already chatter about two of the candidates’ positions on psychedelics. Last week, Frank Biden, President Biden’s brother, called into a SiriusXM show discussing psychedelics, and said he supported their therapeutic use. The show’s host, Michael Smerconish, asked Frank Biden if he’d ever discussed his stance on psychedelics with his brother, and what the president makes of it. “He’s very open minded,” Frank Biden said. 

In a town hall event hosted by cable news channel NewsNation, Democratic presidential hopeful Robert F. Kennedy, Jr. discussed his personal history with addiction — he’s spoken in other interviews about his addiction to alcohol and heroin — and stated that he would legalize psychedelics and marijuana used “for healing” purposes, and tax their sale federally to fund recovery programs and healing centers.  

Harnessing the placebo effect in psychedelic therapy

The placebo effect has been discussed in Western medicine for centuries, and the concept was crucial to developing randomized controlled trials as a methodology to understand medicines’ effects. In a new paper published in the Journal of Psychopharmacology, researchers from Imperial College London, Maastricht University in the Netherlands, and Bar-Ilan University in Israel review the history of placebo and discuss how psychedelic science might harness the power of placebo.

Randomized controlled trials operate under the assumption that drugs’ effects are additive: that is, that it’s possible to separate out the specific effect of a drug from placebo effects. But it’s not that simple, the authors argue. “Person, treatment, and context invariably interact,” they write, and those interactions don’t happen in the same way every time a medication is administered. Psychedelics provide a good example of this variability; in the field, it’s widely acknowledged that “set” and “setting” can affect people’s experiences of the drugs. 

The authors make recommendations based on existing best practices for maximizing psychedelics’ efficacy. This begins with establishing a relationship between facilitators and clients — called “therapeutic alliance” — which plays a large role in helping clients feel supported. The authors write that it is important for a facilitator or therapist to get to know their client by answering client questions, and using active listening to improve clients’ sense of support. The physical space matters too. “Nicely furnished, well lit, and decorated waiting rooms have been associated with higher perceived quality of care; physicians who don a white coat are rated more favorably by patients,” the researchers write. Ritual, too, can help clients feel more comfortable, and clinicians might create rituals that encourage the client to think about the deeper meaning in taking the medicine, or to use props and performance to add meaning to the simple act of being dosed. 

The State of Psychedelics: SB 58 amendment would put California in the footsteps of Colorado and Oregon

Last week, we reported that California’s Senate Bill 58 had passed the state assembly’s Public Safety Committee. The committee also amended the bill, and the text including those amendments was published late last week. The amendments lay the groundwork for the state to launch a regulated psychedelics program, similar to those already underway in Oregon and Colorado.

The bill, as introduced earlier in the legislative session, would make it state-legal for people over 21 to possess, prepare, obtain, and transport the following psychedelic substances: mescaline (excepting peyote), DMT, ibogaine, psilocin, and psilocybin. The law would also make it state-legal for one person to give the substances to others so long as the transaction does not entail “financial gain” (selling drugs would still be illegal). The amended version of the bill delays implementation of facilitated or supported use of those substances “until a framework governing the therapeutic use of those substances has been adopted.” The bill doesn’t include specifics about that framework or who is responsible for creating it. But, as attorney Mason Marks puts it in his newsletter, Psychedelic Week: “This amendment potentially transforms SB 58 from a decriminalization bill to a regulated, therapeutic model of supervised psychedelic administration.”

• “Psychedelic legislation needs common-sense safeguards — a framework for setting and support, harm-reduction education, public-health tracking and first-responder training — not “later” but baked into any drug-reform policy. I don’t believe we can we rely on an industry poised to make billions to worry about safety. Public policy is the mechanism to ensure protections are in place,” writes psychedelic harm reduction advocate Kristin Nash in a San Jose Mercury News op-ed.

• Jamaica has become a popular destination for psychedelic retreats. Writing for Vice, journalist Mattha Busby explores the history underlying the country’s “shroom boom,” and the divide between locals’ and visitors’ experiences of the burgeoning industry.

• How do psychedelics work? For STAT, journalist Olivia Goldhill speaks with researchers to survey the field’s most prominent theories. 

• In a Washington Post op-ed, University of California at Santa Cruz historian Benjamin Breen argues that we need a new way to categorize psychedelics. “Are they recreational drugs? Are they medicines? Are they religious sacraments? History and science argue that they are all three — and more — and how we categorize them is going to be important in determining their place in American society,” he writes.

• WIRED explores the growing role of “psychedelic first responders” — the people who support those experiencing difficult psychedelic trips. 

• Making money in the psychedelics industry will be harder than it’s been in the cannabis industry, writes attorney Griffen Thorne in the Harris Bricken Psychedelics Law Blog.

• Psychedelic Alpha has launched an ibogaine patent tracker.

You’re all caught up! Have a great weekend. We’ll be back in your inbox on Monday with a new issue of 5 Questions.

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