Compass Pathways announced study delays, layoffs; Dispatch from Boston: Advocates rally in support of Question 4
Compass Pathways announced study delays, layoffs; Dispatch from Boston: Advocates rally in support of Question 4
Plus: Regulating psychedelics, and reexamining the FDA’s rejection of MDMA
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.
Compass Pathways announced study delays, layoffs; stock plummets
On Thursday, Compass Pathways had its third quarter business meeting, and announced that top-line data for their phase III clinical trial using COMP360, their proprietary psilocybin product, in treating depression, has been pushed back to the second quarter of 2025. That data was initially expected this summer. The company is also laying off around a third of its workforce.
Directly after the call, the company’s stock dropped more than 25%.
Dispatch from Boston: Advocates rally in support of Question 4
The Microdose was on the ground in Boston this week — I stopped in at a rally on Tuesday at the Massachusetts State House in support of a psychedelics ballot initiative called Question 4. If Massachusetts voters pass the measure next week, the state will become the third in the nation to have a state-regulated psychedelics program, and individuals over 21 will no longer be prosecuted for growing, possessing, and using small amounts of “natural” psychedelics, including psilocybin and DMT.
After Oregon passed a ballot measure creating a psilocybin services program in 2020, psychedelics advocates elsewhere have gained regulatory traction by appealing directly to voters via ballot initiatives. Colorado passed a similar measure in 2022. New Approach, the political action committee behind those two initiatives, also funded Massachusetts Question 4 and created the campaign organization Massachusetts for Mental Health Options. Advocates hope to continue the state-by-state campaign momentum by passing Question 4. Last year, high-profile donors threw their efforts and money behind the initiative; according to campaign finance records, philanthropist Blake Mycoskie (formerly of TOMS shoes) contributed $500,000, and All One God Faith Inc, the company behind Dr. Bronner’s soaps, gave $1 million to kick off the campaign. Over the last month, fundraising has ratcheted up, with some donors contributing even more funds; All One God Faith, for example, gave an additional $250,000. MAPS also joined the donor list, giving $500,000.
At the event on Tuesday, several dozen advocates gathered at the Massachusetts State House in downtown Boston as tourists and school groups snapped photos. The actor Eliza Dushku Palandjian, best known for her roles in Buffy the Vampire Slayer, Bring It On, and Dollhouse, kicked off the rally with an appeal to the Boston crowd: the city was the birthplace of other medical innovations, she said, from the first cardiac surgery to the first successful AIDS treatment, and now had the opportunity to lead on psychedelics. Dushku Palandjian, who is now training as a psychedelics therapist herself, has given $250,000 to the campaign. Her speech set the tone for the event; she highlighted the urgency of “more mental health options” while also addressing some of the opposition’s claims. “Our opponents claim this effort is moving too fast,” she said. “But Question 4 will establish a two year rulemaking process leading to the establishment of a state agency that will be guided by an expert advisory board to provide oversight and guidance. That's not too fast.”
Following Dushku Palandjian at the podium was Bessel van der Kolk, the psychiatrist known for his best-selling book The Body Keeps the Score. Van der Kolk compared underground psychedelic use to illegal abortions. “As long as you keep these things illegal, terrible things will happen,” he said. Next up was Harvard psychiatrist Franklin King, who also discussed the risks of underground psychedelic use. “Illegal psychedelic therapy is happening all around us,” he said. “Criminalizing these behaviors reduces safety by preventing patients from disclosing their activities to doctors, preventing doctors from talking about this with their patients, and thereby losing valuable and, in many cases, crucial opportunities for harm reduction.” King also criticized the opposition, pointing out that the No on Question 4 campaign is chaired by a surgeon. “That speaks volumes to the fact that the opposition could not even find a psychiatrist to represent their leadership,” he said.
Hannah McLane, a physician and founder of the psychedelic facilitator training program SoundMind, started her address by joking that if she could’ve named the campaign, she would’ve called it “Mushrooms for Massholes,” or “Plants Over Pills.” She emphasized the potential power of “natural” psychedelics like psilocybin, and how Massachusetts could help set the national tone for psychedelics. “Federal level approvals will still happen within five or more years, but we don't have time to wait,” McLane asserted. Question 4 would “give the power to price treatment options to the state rather than federal pharmaceuticals driving the narrative,” McLane said.
After the rally, a few dozen people lingered to chat. Several attendees told me they already worked in the psychedelics underground and wanted to help bring their practices above ground. Others said they’d been recruited into the Yes on 4 crowd by grassroots organizers employed by the campaign. New Approach, the PAC behind most of the state psychedelics initiatives, has also enlisted Dewey Square Group, a media relations firm, to help with the campaign. At the rally, representatives from Dewey passed out “Yes on 4” signs, stickers, and t-shirts, and arranged a diverse group of advocates along the steps of the state house building behind the speakers’ podium. While technically part of the same campaign, the efforts of the grassroots organizers appeared somewhat separate from that of the official media relations firm. Jamie Morey, community engagement director of Massachusetts for Mental Health Options, gave out her own Yes on 4 stickers, which had a decidedly trippier feel than Dewey’s.
The group then headed to a luncheon sponsored by Dewey and held at a progressive Christian church a few blocks away. (Because this was Boston, a bust of the church’s namesake, Emanuel Swedenborg, sat in the corner, next to a box of sandwiches.) The half-dozen or so attendees I spoke with were optimistic but nervous about the election next week, citing recent poll results suggesting that Massachusetts voters are fairly evenly split between supporting and opposing Question 4. On Wednesday, the day after the rally, new polling data from Emerson College Polling and Boston TV station WHDH indicated the race remains close: 50% of those polled indicated they would vote yes on Question 4, 44% would vote no, and 6% said they are unsure.
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Regulating psychedelics
A new article in the Administrative Law Review gives an overview of the legal status of psychedelics, including the drugs’ history, the regulations for rescheduling drugs, and current regulatory hurdles to psychedelic research. In the 39-page article, author and American University law student Saumya Sinha argues that current policies could have serious negative consequences for the sector. For instance, she cites a federal 2023 congressional appropriation bill, which specifically dictated that those federal funds could not be used to promote the legalization of any drug, “allows large pharmaceutical companies to monopolize the market and charge exorbitant prices, which, in turn, limits access to useful treatments.” Additionally, Sinha argues, “Schedule I classification also leads to individualized local and state-level measures to decriminalize psychedelics, making it difficult to create a consistent regulatory scheme.”
Sinha suggests that once the U.S. Food and Drug Administration grants approval for MDMA, the agency should recommend that the drug be classified as a Schedule III drug, and that if the FDA approves psilocybin, that the drug be classified as Schedule IV. Both Schedule III and IV drugs are determined to have accepted medical use; Schedule III drugs are classified as having lower potential for abuse than Schedule I or II drugs, and Schedule IV drugs have even lower potential for abuse compared to Schedule III drugs. Sinha also recommends guidance for state licensing boards. “Given that FDA does not regulate the therapeutic context, such guidance will help direct states to adopt a more uniform regulatory scheme and promote safe use of these substances,” she writes.
Reexamining the FDA’s rejection of MDMA
In commentary published recently in Nature Mental Health, University College London neuroscientist Eduardo Schenberg, University of Exeter philosopher Christine Hauskeller, Karl Landsteiner University of Health Sciences researcher Claudia Gertraud Schwarz, and Harvard psychiatrist Franklin King examine factors they believe played a role in FDA’s rejection of Lykos’s New Drug Application for MDMA. Specifically, they analyze statements made during the FDA’s Psychopharmacologic Drugs Advisory Committee meeting in June, during which it voted overwhelmingly to reject MDMA-assisted therapy in the treatment of post traumatic stress disorder. That meeting was held two months before the FDA released their final decision on the New Drug Application in August.
The authors argue that it was misguided for the FDA to ask advisory board members to vote on the efficacy of MDMA alone, when psychotherapy was a large component of the treatment used in clinical trials. They also suggest that the committee’s concerns about functional unblinding — trial participants being able to guess whether they’d received MDMA or a placebo — should not have been a strong factor in FDA’s decision, given that such unblinding is “inevitable with interventions that produce unmistakable perceptual effects.” They also point out that relatively few clinical trials assess blinding, and that other drugs, including ketamine, have been approved despite concerns about blinding. “Demanding perfect blinding in studies that involve psychoactive substances is unreasonable and could impede development of innovative treatments,” they write.
The commentary also takes issue with the make-up of the advisory committee. “The FDA advisory committee consisted primarily of psychiatrist researchers, with one statistician and one consumer representative; it did not include psychologists or psychotherapists. This likely led to the psychological intervention being seen as confounding the effects of the drug, rather than correctly appreciated as part of the treatment,” they write.
The New York Times profiles Jasveen Sangha, the “ketamine queen” who has been charged with providing black market ketamine to the late actor Matthew Perry.
The non-profit psychedelic research company B.More and the NYU Langone Center for Psychedelic Medicine announced they have been awarded a multi-million dollar grant from the National Institute of Drug Abuse to study the efficacy of psilocybin in treating opioid use disorder. The 5-year grant will provide $3 million per year for a total of 5 years, dependent on progress during the first 2 years.
A new paper in BMC Medical Education makes recommendations about rolling out psychedelic-assisted therapies in Germany.
In an essay published in Granta, the writer Tao Lin probes what he calls “the two main factors in my spiritual development: my DMT trips and the near-death experience (NDE) literature.”
New Scientist profiles the work of researcher Zeus Tipado, who plans to dose participants with DMT and have them interact with virtual reality while scanning their brains.
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