Public comments on upcoming FDA Advisory Committee; ICER council votes evidence for MDMA-assisted therapy is inadequate; and disentangling psychedelics and therapy

Plus: Could California see psychedelics on its 2026 ballot? And psychedelics for grief

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.

Public comments on upcoming FDA Advisory Committee on MDMA-assisted therapy 

Next Tuesday, the U.S. Food and Drug Administration’s Psychopharmacologic Drug Advisory Committee will hold a meeting to discuss Lykos’s new drug application for MDMA for use in the treatment of PTSD. This week, the FDA announced that it is extending the meeting by an hour to allow for an additional 45 minutes of public comment. (The full meeting agenda is available here.)

As of Thursday, the agency has received 54 comments, with a wide mix of supportive and critical statements. Commentary submitted by groups including BrainFutures, the Wounded Warrior Project, and the Disabled American Veterans underscored the lack of effective treatments for PTSD and the potential of MDMA to help those in need. “There is an urgent and pressing need for innovation to treat PTSD, and Lykos’ current research indicates MDMA may make psychotherapy more effective,” Disabled American Veterans wrote in their statement. “As the FDA considers how this evidence significantly reduces PTSD symptoms, DAV points to the hundreds of veterans choosing to go abroad to unregulated medical facilities in search of the treatments currently unavailable to them in the U.S.” 

Many letters also express concern. The American Psychiatric Association (APA) cautioned the agency to consider the role of both participants’ and researchers’ expectations in driving treatment results. The APA wrote that it “encourages [the Advisory Committee] to consider if the research is too limited and whether guardrails must be incorporated for public safety.” MAPS clinical trial participant Sarah McNamee wrote that she’s met other participants who experienced serious adverse effects that were not reported in journal articles about MAPS’ trial results. McNamee, a Montreal-based psychotherapist, also details conduct by her trial therapists during the trial that she “would never do as a therapist or as a researcher,” including “pressuring me to cuddle with them; repeatedly telling me I was ‘helping make history’ and that I was ‘part of a movement’; and letting me know how my responses and behaviours during and after the trial could jeopardize legalization.” (The Microdose reached out to Lykos for comment but did not receive a response before publication.) 

ICER council votes evidence for MDMA-assisted therapy is inadequate

Yesterday, the New England Comparative Effectiveness Public Advisory Council held a public meeting to discuss a recent report assessing Lykos Therapeutics’ clinical evidence for using MDMA-assisted therapy to treat PTSD. The New England council is one of three appraisal committees of medical and health policy experts that assess the evidence presented in reports published by the Institute for Clinical and Economic Review (ICER), a nonprofit research institute whose reports are referenced by insurers and healthcare professionals in decisions about medical policy and insurance coverage. Earlier this month, ICER published a report that concluded that Lykos’s clinical evidence for MDMA-assisted therapy’s efficacy in treating PTSD is “insufficient.” 

In the six-hour meeting, the 15 voting members of the New England Comparative Effectiveness Public Advisory Council reviewed and discussed the results of MAPP1 and MAPP2 (Lykos’s two MDMA Phase 3 clinical trials). They also heard from five speakers during a public comment session; voted on a series of questions on the evidence from the clinical trials; and discussed logistical and ethical issues that require attention should the drug be approved by the FDA. 

In general, the committee appeared open to the possibility that MDMA-assisted psychotherapy could help patients, but they expressed concerns that participants’ and researchers’ expectations could have biased results, and that variation in psychotherapeutic approaches made it difficult to compare MDMA-assisted psychotherapy’s effects to other therapies, and to the study’s control group. They also discussed whether potential benefits of treatment outweighed potential harms. “For me, these evidence questions boil down to the issue of: do we have confidence in what are on the surface pretty impressive results in light of the constellation of issues that have been raised by the ICER team and others around the design, the conduct, and reporting of the trial?” said Jason Schwartz, an associate professor at the Yale School of Public Health. “While some of them can be contextualized in isolation, like blinding, it’s hard for me to construct a story that gives me confidence that all of these issues have a reasonable explanation.” In the committee’s vote, 14 of the 15 voting members said there was not adequate evidence to demonstrate that the net health benefit of MDMA-assisted psychotherapy was superior to not treating patients with MDMA-assisted psychotherapy. All 15 committee members said that the current evidence was inadequate to demonstrate that MDMA-assisted psychotherapy was superior to the current standard of care, which is short-term trauma focused psychotherapy. 

Another recurring theme was Lykos’s refusal to participate in the report process, and unresolved conflicts between statements from Lykos or MAPS and other stakeholders. For example, study participants told ICER they were excluded from a follow-up study of participants’ long-term outcomes, which ICER included in a draft report. In public comment submitted to ICER, a MAPS researcher denied this, which ICER included in an updated report. After that report was published, a participant sent ICER an email exchange in which a MAPS researcher appeared to exclude them from the follow-up study. “While it is not within ICER’s ability to fully investigate this email trail, the patient reports they have submitted this exchange to the FDA,” said David Rind, Chief Medical Officer at ICER. At several points during the meeting, members of the committee expressed their desire for Lykos to participate in the review process or meeting so their response to allegations or clinicians’ methodological questions could be heard. Rind tells The Microdose that while Lykos did speak with ICER a few times, the company’s lack of participation is relatively uncommon for companies whose drugs are evaluated by ICER. “Companies almost always make comment at public meetings, and they didn’t do that,” he said. (The Microdose reached out to Lykos for comment but did not receive a response before publication.) 

ICER said that its final report, which will include a description of the CEPEC’s votes and discussion, will be released around June 27, and a recording of the meeting will be available on ICER’s website next week. 

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Disentangling psychedelics and therapy

Currently, almost all psychedelic studies use some form of therapy or facilitation together with the psychedelic to treat participants. A new paper in Psychopharmacology questions why there is not more robust research on the therapy part. “Current approaches to psychotherapy in psychedelic-assisted psychotherapy are largely the product of trial-and-error from early psychedelic researchers and contemporary community or ‘underground’ psychedelic practitioners,” the researchers write. “Although these sources of knowledge have been incredibly valuable for the field, systematic study of the psychotherapy in psychedelic-assisted therapy has been lacking.”

Existing studies of psychedelic-assisted therapy use a wide variety of different approaches to psychological treatment. Some are based upon established therapeutic modalities such as Cognitive Behavioral Therapy (CBT), Internal Family Systems (IFS) therapy, Eye Movement Desensitization and Reprocessing (EMDR) therapy and Motivational Enhancement Therapy (MET). Others focus on strategies like psychoanalysis, virtual reality, and general mindfulness. Without standard protocols, it is difficult to understand the role psychotherapy plays in the effectiveness of treatments that use a combination of therapy and psychedelic drugs. The wide variability in therapists’ approaches can also make it difficult to replicate studies.

Could California see psychedelics on the 2026 ballot?

Two weeks ago, California Senate Bill 1012, which would have created a state-regulated program to oversee therapeutic uses of psilocybin, MDMA, DMT, and mescaline, died in Senate Appropriations Committee. (At the time, Wiener acknowledged the state’s budget shortfall and its role in the bill’s demise.) Now, Bay Area NPR affiliate KQED reports that the bill’s sponsor, Senator Scott Wiener, plans to redouble his efforts next year with legislation as well as a potential push for a ballot initiative, similar to those that established psilocybin programs in Oregon and Colorado. 

SB 1012’s quick end came as a surprise to many advocates; last legislative session, Wiener’s psychedelics decriminalization bill passed the legislature but was vetoed by Governor Newsom.  In a letter to the California Senate explaining his veto, Newsom “urge[d] the legislature to send me legislation next year that includes therapeutic guidelines.” 

Psychedelics for grief

Psychedelic-assisted therapy has been studied as a treatment for mental health issues including depression and PTSD, and a new paper in the International Review of Psychiatry suggests it might also help treat prolonged grief disorder. Prolonged grief disorder is characterized by intense thoughts of a loved one, emotional numbness, and difficulty moving on. Currently, most treatment options are psychological rather than pharmacological. The paper’s authors suggest that common effects of psychedelics, such as feelings of connectedness and a deeper sense of meaning, may be helpful for those with prolonged grief disorder. In the authors’ observational and survey-based research, participants report that psychedelics have helped with their grief, and the authors suggest conducting a clinical trial to better understand whether psychedelics could be used to treat the condition.

• The U.S. Government Accountability Office published a report recommending that the Drug Enforcement Administration take steps to clarify how the agency evaluates requests from petitioners trying to access psychedelics for religious or ceremonial use, and to provide information to those petitioners about timeframes and updates on their requests. 

• Some law enforcement officers are turning to psychedelics to treat their trauma. DoubleBlind interviews current and former law enforcement officers about their experiences with the drugs.

• An Atlanta City Council member has proposed that the city’s human resources department study the pros and cons of psilocybin and ketamine to treat mental health issues, and whether the city’s employee health plan should pay for it, reports Axios. 

• The non-profit Women’s Visionary Council and Berkeley’s psychedelic salon The Chalice are holding an event on June 12 to celebrate “Tram Day,” a new psychedelic holiday honoring Susi Ramstein. Ramstein was the lab assistant of Albert Hofmann, best known for inventing LSD and then riding his bike home after taking the drug in his lab. Ramstein, according to the event description, was “the first woman to take LSD and sensibly, took the tram home.”

You’re all caught up! Have a great weekend. We’ll be back in your inbox on Monday for a new issue of 5 Questions, and again on Tuesday with special coverage of the U.S. Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee meeting to discuss Lykos’s new drug application for MDMA.

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