U.S. Food & Drug Administration will hold advisory committee meeting on MDMA; A psychedelics research bottleneck in California; and psilocybin meta-analysis under post-publication review
Plus: More opposition to Massachusetts’ psychedelics bill, and researchers publish consensus statement on ethics
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.
U.S. Food & Drug Administration will hold an advisory committee meeting in June
This week, the U.S. Food and Drug Administration (FDA) announced a public advisory committee meeting scheduled for June 4 to discuss Lykos Therapeutics’s application to use MDMA-assisted therapy to treat PTSD. In April, a group of psychedelics scholars and other concerned community members started a petition calling on the FDA to schedule an open advisory committee meeting to discuss concerns about Lykos’s New Drug Application. The June 4 meeting will be held at the FDA’s campus in Silver Spring, Maryland and will include public comment via a video conference platform. The agency is also accepting written public comment through June 3; comments submitted by May 23 will be provided directly to committee members.
In the advisory committee meeting, members of the FDA’s Psychopharmacologic Drugs Advisory Committee will review data from Lykos’s clinical trials. Recently, those data have faced public scrutiny, as a March draft report from the research non-profit Institute for Clinical and Economic Review raised methodological and ethical issues with the studies; people who worked on Lykos’s trials have refuted those criticisms.
Bill seeks to end California psychedelic research bottleneck
Last week, members of the California Assembly’s Health Committee voted unanimously to advance AB-2841, a bill that allows the state’s Research Advisory Panel to hold closed sessions. That panel reviews all research projects involving opioid, stimulant, and hallucinogenic drugs classified as Schedule I and II. The panel had been meeting privately, but after recent changes to a state law that requires public agency meetings remain open to the public, the panel stopped meeting altogether, concerned that holding public meetings could jeopardize the confidentiality of applicants’ research proposals. In January, Psychedelic Alpha first reported on this issue; meetings scheduled for October and November 2023 were canceled without explanation, and those canceled meetings meant psychedelics-related studies were not being approved.
According to state officials interviewed by the Los Angeles Times, the panel has not met since last August, and it currently needs to review 42 new studies and amendments to 28 existing projects. AB-2841 authorizes the Research Advisory Panel to hold closed sessions so it can discuss applications that include intellectual property or trade secrets. Next, the bill will head to the full State Assembly for a vote.
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Psilocybin meta-analysis under post-publication review
Last week, the British Medical Journal published a meta-analysis of seven clinical trials investigating psilocybin’s efficacy in treating depression, in which the authors reported that “psilocybin treatment showed a significant improvement in depression scores.” Just days later, a group of researchers wrote an editorial to BMJ’s editors expressing concerns about the study’s statistical methods. The meta-analysis reported extremely high values for what’s called Hedge’s g, a measure of changes in depression scores. A Hedge’s g value of 0.2 indicates a small change, while 0.8 corresponds to a large change, but the meta-analysis reported Hedge’s g values as high as 3 or 4. In their editorial, the researchers report additional “reporting and analytical inconsistencies” and the meta-analysis’s failure to make its dataset publicly available.
In a corrections statement, the BMJ wrote that the authors are “reviewing and responding to the error” and that their initial results are “likely to have overestimated the benefits of psilocybin.”
New coalition to oppose Massachusetts psychedelics bill
The state of Massachusetts is currently considering the Natural Psychedelic Substances Act, a ballot initiative introduced in August 2023, which would allow people in the state to cultivate, obtain, possess, transport, or ingest psilocybin, psilocin, DMT, ibogaine, and mescaline for personal use.
The initiative has faced opposition from local activists for months; now, it faces new opposition. Last week, Anahita Dua and Charles Gantt filed with the state’s Office of Campaign and Political Finance to establish an organization called the Coalition for Safe Communities to oppose the Natural Psychedelic Substances Act. Dua, the group’s chair, is a surgeon at Massachusetts General Hospital, and Gantt, its treasurer, runs a political firm that receives millions a year from the Trump campaign. Their spokesperson, Chris Keohan, told the Boston Herald that the coalition feels the proposed act “goes way too far way too quickly,” and believes that allowing people to grow psilocybin mushrooms at home is “definitely not safe.”
After receiving 75,000 signatures in November, the Natural Psychedelic Substances Act ballot initiative went to the state legislature for consideration. The legislature could have passed the measure or proposed a substitute initiative, but it chose a third option: to take no action. That means the ballot initiative requires another 12,429 signatures by early July to make it onto the state’s fall 2024 ballot.
Psychedelics researchers publish consensus statement
This week, over two dozen psychedelics scholars published an article in The American Journal of Bioethics detailing their group’s consensus on ethical issues in psychedelics. The group met in August 2023 at the University of Oxford, and the published piece represents the group’s “shared understanding” and positions on a variety of psychedelics-related ethical issues. (It is also published on a website the group made to house the statement, where it has also been translated into French, Spanish, Portuguese, Dutch, and German.)
The group agreed that Indigenous communities, who have long used psychedelics, should be recognized as having valuable insights, and that researchers should acknowledge cultural appropriation as a risk of increased decriminalization and medicalization of psychedelics. They also emphasize a need for a better understanding of psychedelic risks, for harm reduction and education programs, and for clearer codes of conduct for psychedelic practitioners. The group also reported remaining divided on the use of therapeutic touch during psychedelic experiences, and acknowledged that “clear and transparent codes of conduct” to minimize potential for abuse and manipulation should be a part of ongoing professional discussions.
Grass Valley, California was once known for cannabis — but now, local artist Brian Chambers is bringing psychedelics to the forefront, reports the Los Angeles Times.
The Common, a podcast produced by Boston NPR affiliate WBUR, published the first of a three-part series on the past, present, and future of psychedelics. This week’s episode discusses the legacy of Timothy Leary in Massachusetts.
The Ohio State University alum Christopher Pan, an entrepreneur, was invited to give the commencement speech at his alma mater, and, according to Pan, he turned to ayahuasca for inspiration. The resulting speech was panned by attendees; it included a pitch to invest in Bitcoin and a rendition of 4 Non Blondes’ “What’s Up” followed by a box breathing exercise.
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