FDA releases psychedelic recommendations; best practices in obtaining informed consent for psychedelic therapy; new NJ bill, CA bill advances

Plus: Psychedelics users more likely to support legalization than medicalization; and consumption limits and product labeling in 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. 

FDA releases psychedelics recommendations

Last Friday, the U.S. Food and Drug Administration issued its first-ever draft guidance on psychedelics. The document provides “non-binding recommendations,” which are different from actual FDA rules and regulations. According to Tiffany Farchione, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, the agency’s recommendations are meant “to assist researchers in designing studies that yield interpretable results to support future drug applications.” Many researchers and industry insiders are hopeful that the FDA will approve psilocybin and/or MDMA for therapeutic use in the next several years.  These recommendations provide important insights into how the agency is evaluating ongoing clinical trials involving psychedelics. 

In its guidance document, the FDA recommends that clinical trial sponsors consider excluding people from participating in studies if they have pulmonary hypertension or heart valve issues, since classic psychedelics “may induce cardiac valve stiffening.” The agency also suggests that the psychotherapy part of psychedelic-assisted therapy has “the potential to increase expectancy and performance biases” in both study participants and the researchers conducting the studies. As a result, the agency recommends that in clinical trials, any therapist that accompanies participants during a psychedelic trip should not provide post-session integration therapy, “because their knowledge of the treatment could bias the delivery of subsequent therapy.” Members of the public can submit comments on the draft guidance through August 25. 

Best practices in obtaining informed consent for psychedelic therapy

Psychedelics can greatly alter consciousness, potentially making a person more suggestible and vulnerable to abuse. (Several cases of alleged psychedelics-related abuse have come to light in recent years.) Portuguese clinical researchers, psychiatrists, and ethicists collaborated on a new paper published in Nature Medicine highlighting the ethical and regulatory challenges around psychedelic therapy. 

The authors suggest solutions to those challenges, such as obtaining informed consent from participants that includes “full disclosure and detailed discussion of the potential effects;” preparing for the “potential need for rescue interventions, such as antipsychotics for agitation;” and agreed-upon boundaries for any touch between therapists and clients seeking treatment. Informed consent, the authors write, “should include informing patients about the possibility of feeling closer or more familiar to clinicians, and potential impact on vulnerability to abuse.” They also state that regulatory agencies and professional societies should oversee consent processes and training for practitioners.

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The State of Psychedelics: New NJ bill, CA bill advances

Last Friday, New Jersey senators Nicholas Scutari (D), Holly Schepisi (R) and Andrew Zwicker (D) introduced Senate Bill 2934, which would create a Psilocybin Behavioral Health Access and Services Advisory Board within the state’s Department of Health. The board would issue recommendations on establishing and regulating psilocybin services in the state.

On Tuesday, the California State Assembly’s Public Safety Committee voted to pass Senate Bill 58, which 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.” In other words, selling drugs would still be illegal. The bill passed the California Senate earlier this month and now heads to the full Assembly for a vote. (For more on SB 58’s history, read our 5 Questions for California state senator Scott Wiener, the bill’s sponsor.

Tweet via @Scott_Wiener 

New study: Psychedelics users more likely to support decriminalization and legalization policies than medicalization

In a study recently published in the Journal of Psychoactive Drugs, Michigan researchers surveyed over 1200 attendees of a psychedelic advocacy event called Entheofest about their support for psychedelic policies and practices. Survey participants were very likely to support legalizing the possession of psychoactive plants and fungi, as well as individual gifting and selling of those psychoactive substances, also known as entheogens. They were less likely to support individuals selling entheogens, and were on average unsupportive of companies obtaining patents for psychedelics. While they were overall very supportive of therapists administering psychedelics during guided therapy sessions and healthcare professionals prescribing psychedelics for use outside of healthcare settings, they were only somewhat supportive of healthcare professionals administering psychedelics without therapeutic support. “As psychedelic liberalization continues to advance, we believe it is critical for policymakers to consider these preferences to ensure laws provide safe and equitable access to these substances and appropriate medical support for their use,” the authors conclude. 

The Latest in Oregon: Consumption limits and product labeling

On June 7, members of psychedelics nonprofit Healing Advocacy Fund’s Safety Committee drafted a letter encouraging manufacturers and service centers operating in Oregon to propose best practices around the labeling and dosage of psilocybin products. The letter was signed by licensees, nurses, doctors, and a former Oregon Health Authority (OHA) director. 

Currently, the rules established by the OHA require labs to test for psilocybin and psilocin but do not require manufacturers to include psilocin content on labels. “This could render current dosage tables and administration rules significantly off-base, possibly resulting in a session longer and far more intense than expected,” the letter reads. “For example, if a serving is labeled as having 10 mg of psilocybin yet it also contains 8 mg of psilocin not stated on the label, then the psilocybin-equivalent potency would be about 21 mg.” 

Additionally, the letter points out that OHA’s rules allow clients to receive up to 50mg of psilocybin, while 30mg of the drug is known to produce very intense trips. “OHA may wish to revisit its rule that currently allows up to 50 mg to be given,” they write. “We currently take no position on this, other than that all parties should be well educated on dosing.”

The following week, Oregon Psilocybin Services’ section leader Angie Allbee sent a letter to all state licensees addressing the concerns laid out in the committee’s letter. She emphasized that all OHA rules are minimum standards. “If licensees choose to adopt practices that exceed the minimum requirements established in rule, they are welcome to do so,” she wrote.

• In case you missed it, here’s our coverage from days 1, 2, 3, and 4 of the Psychedelic Science 2023 conference in Denver last week. 

• New York Mets owners Steve and Alexandra Cohen donated $5 million to MAPS.

• Microdosers say the practice helps them feel better and more creative — but science about the practice is still inconclusive, I wrote in The Washington Post. 

• Colorado Public Radio reports on the state’s emerging psychedelic gray market and Senate Bill 290, which adopts policies to implement the state’s Natural Medicine Health Act (NMHA).

• VICE digs into the Church of Psilomethoxin’s history and claims about its sacrament.  

• What does the IRS have to say about psychedelics religious organizations that want non-profit status as 501 c3? 

• The Bend Bulletin profiles Bendable Therapy, an Oregon nonprofit dedicated to subsidizing the cost of psilocybin sessions for people seeking the drug as a mental health treatment. 

• Psychedelic watchdog organization Psymposia pulled information from the Psychedelic Science 2023 app about speakers’ conflicts of interest. “Because this information is located on a mobile app that is likely to disappear one day, Psymposia is preserving a copy for public reference on its website,” wrote journalist Russell Hausfeld. (The app’s list covered only speakers who appeared in sessions that could be used as continuing education credits for attendees.) 

• “Bird that can read everyone’s thoughts welcomed as keynote speaker of psychedelics conference,” reads a headline in The Onion. 

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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