In this Issue
California’s Psychedelic Research Bottleneck Ends Today
Letter to the Editor: Neşe Devenot
A Look at Complaints as Oregon Psilocybin Services Turns One
Disability and Psychedelics
Other Stories
***
Today, the Research Advisory Panel of California (RAP-C) is sitting for the first time since last summer. While somewhat obscure, the panel is a key roadblock for studies primarily involving Schedule I or II controlled substances, or studies of addiction that employ any scheduled or non-scheduled medication.
In recent years, many of the research projects that fit under the panel’s remit have been psychedelics studies, owing to the increased popularity of the field. Given that investigators must obtain—and maintain—the panel’s approval for such studies, its failure to convene for the better part of a year had brough all new psychedelic studies to a halt in the most popular state of the union.
The issue that led to the panel’s stasis was the blunt enforcement of the Bagley-Keene Open Meeting Act, which generally requires state boards and commissions to conduct and service meetings in public, unless closed sessions are explicitly permitted.
However, amendments to Bagley-Keene and/or its interpretation apparently made it difficult for RAP-C continue operating in accordance with study sponsors’ frequent expectation of confidentiality (especially where study documents are proprietary to a sponsor), as well as panellists’ expectation—or preference—that scientific review be undertaken anonymously.
Bagley-Keene, then, compromised both sponsors’ and academics’ expectations of privacy, which led to a total impasse and the cancellation of all meetings. (For more background on the impasse, see our January coverage, which broke the news: The Obscure Advisory Panel Blocking Dozens of Psychedelic Studies in California.)
Following our coverage, as well as reporting in mainstream outlets and a coordinated push from frustrated substance use disorder and psychedelics researchers, Republican Mary Waldron sponsored Assembly Bill 2841. That Bill sought to have RAP-C explicitly authorised to hold closed sessions in order to review research projects that contain “sensitive and confidential information” such as trade secrets or proprietary information.
AB 2841 was introduced in February, passed unanimously on the Assmebly Floor on July 3rd, and approved by Governor Newsom just yesterday. Given an urgency clause in the bill itself, it goes into effect immediately.
Today’s meeting, then, is good to go.
And it should be a lengthy one. While the panel has been unable to meet, both academic and commercial sponsors have continued submitting their proposed research projects, meaning RAP-C’s agenda for today includes the review and potential approval of more than sixty studies.
Commercial sponsors include Relmada Therapeutics, Reunion Neuroscience, and Compass Pathways; while the list of academic and research institutions is broad: from UCSF, UCLA and UCSD through to NIDA, Stanford, and the Lawrence Berkeley National Lab.
So, the panellists will have a busy afternoon ahead of them, with the meeting set to begin shortly after this article publishes.
While some would have preferred to see the panel dissolved entirely, this compromise at least allows new psychedelics research projects to get underway in the golden state once more.
***
In our last Issue of the Bulletin, I curated responses to Lykos’ critics: i.e., I paraphrased comments I had received/heard from Lykos insiders, affiliates, and others close to the matter. (See Lykos Insiders, Affiliates, Respond to Critics.)
Since the publication of that piece, a vocal critic of the company—who has been named outright in several prominent instances—contacted me to share her side of the story. Here, Neşe Devenot shares a Letter to the Editor on the topic…
During the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) meeting, I served as a proxy for Lykos Therapeutics (formerly MAPS PBC) whistleblowers and participants, because people were already afraid of retaliation by the time they contacted me. The response from Lykos supporters continues a longstanding tendency to portray those who speak up about harms as a threat to the movement.
This pattern feeds into a climate that is hostile to harm reduction, creating an environment where it is impossible to know the full scale of the harms associated with psychedelic clinical trials. That climate poses a substantial barrier to conducting rigorous research, to creating safer psychedelic cultures, and to communicating effective harm reduction information.
It is also dangerous to me personally. On June 23, I was targeted by name in a dishonest Heroic Hearts open letter that launched a coordinated PR campaign as political cover for the FDA’s upcoming decision. In a context of increasingly normalized political violence, the decision to contemptuously blame me for jeopardizing the movement is painting the target on my back even brighter.
The reason we have not shared more information publicly is that we have an obligation to protect the safety of our contacts. We are in touch with 8 contacts with evidence of systemic problems and overlapping abuses across Phase 3 trial sites. This includes Phase 2 and 3 participants, former employees, and clients of Phase 3 therapists and MAPS-trained guides. Collectively, their experiences provide undeniable evidence of widespread corruption and ethical violations that undermined the integrity of data collection and reporting. (Editor’s note: Owing to confidentiality concerns, Psychedelic Alpha is unable to review these claims.)
Prior to contacting us, our contacts witnessed the field’s treatment of the Phase 2 participant who came forward, and they are seeing how leaders in the field still blame her for assaults that occurred during the trial. As the Phase 2 participant reported to the IRB in 2018 and to the FDA in 2021, those assaults were preventable and predictable consequences of the MAPS therapy protocol. Despite that participant’s requests for an investigation to protect future participants, no such investigation took place, and similar harms from the therapy protocol continued into Phase 3.
If these incidents had been properly investigated when they were initially reported, I would not have needed to speak to the PDAC on June 4. Patient advocates should not be attacked for engaging in “the democratic arts of education, organizing, and mobilizing people for change,” when change of some kind is clearly necessary.
The overt contempt by some Lykos supporters is making it harder for that information to become public. Our contacts are still hoping to cooperate with an independent FDA investigation, but no one has yet been contacted.
While we agree with the votes at both ICER and FDA’s PDAC, we were just as shocked about ICER’s report as everyone else. We were not involved in their draft, and we did not see it coming.
I am an Indigenous Kurdish scholar and C-PTSD survivor advocating for other victims of trauma. I’ve been a psychedelic researcher since 2010, because psychedelics saved my life. I challenged Lykos’ MDMA-assisted therapy application not because I don’t understand the value of psychedelics, but because they’re so important that we need to get this right. Lykos’ therapy is causing predictable patterns of preventable harm, and I believe it is in the best interest of the field to recognize this and make meaningful changes.
I was grateful for Jules Evans’ rapid reporting, for Peter Addy’s open letter, for Josh Hardman’s observations, and for everyone who stepped forward to challenge dangerous rhetoric that is demonizing us as political enemies. Building a safer field is a collective responsibility, and it will make for better science.
– Neşe Devenot
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