Revisions made to report critical of Lykos’s research on MDMA-assisted therapy; Lawsuit postpones hearing for contentious DEA proposal; and former MAPS employees make troubling allegations

Plus: Alaska psychedelic task force bill passes; California research panel bill advances to senate while regulated access bill stalls; and the nocebo effect

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.

Revisions made to report critical of Lykos’s research on MDMA-assisted therapy

On Tuesday, the Institute for Clinical and Economic Review (ICER), a non-profit research institute, published a revised report assessing Lykos Therapeutics’ clinical evidence for using MDMA-assisted therapy to treat PTSD. In the revised report, ICER responds to public comments it received on the draft report it published last month. The differences between the revised report and initial draft are negligible, and the group maintains its original conclusion: the clinical evidence for MDMA-assisted therapy’s efficacy in treating PTSD is “insufficient,” the research group’s lowest rating.

The 16 comments ICER received on its draft report included a response from Lykos, which said it was “disappointed” by the report, as well as responses from researchers who worked on Lykos’s clinical trials. Pharmaceutical company Otsuka, which acquired Canadian psychedelics company Mindset Pharma last year, also wrote in to say that it agreed that some of the issues the draft report raised were “concerning and may have skewed the results of the trial and efficacy/safety data of [MDMA].” Individuals and advocacy groups including the Disabled American Veterans wrote in to underscore the importance of finding novel solutions to treating PTSD; researchers from the Partnership to Improve Patient Care, Northeastern, King’s College London, and UC Berkeley recommended changes to ICER’s model to better reflect MDMA-assisted therapy’s potential benefits. 

After ICER’s draft report was published in April, people who worked on Lykos’s clinical trials published a rebuttal to the criticism in the publication Psychedelic Alpha, saying that they were not consulted about the report. The rebuttal was also submitted as public comment to ICER. In their response, ICER said they reached out to Lykos but the company “declined to collaborate with us, and did not provide us with any relevant contacts to engage with,” and as a result, ICER didn’t reach out to individual investigators. The report also reveals that MAPS founder Rick Doblin was the one who reached out to ICER to suggest that MDMA-assisted therapy might be an appropriate topic for an ICER review.

After ICER publishes its reports, it convenes three appraisal committees of medical and health policy experts to assess the evidence presented in its reports, and vote on them. One of those committees, the New England Comparative Effectiveness Public Advisory Council, will hold a public meeting on May 30 to discuss the revised report. 

Lawsuit postpones hearing for contentious DEA proposal

A June 10 hearing about a U.S. Drug Enforcement Administration proposal to ban psychedelic drugs DOI and DOC, which are often used in scientific research, has been postponed, according to the legal news site Law 360. The DEA filed the proposal in December 2023, its second move in two years to classify two previously unscheduled hallucinogens known as DOI and DOC as Schedule I drugs. Psychedelics researchers have spoken out against the proposal, saying it would hinder ongoing research that uses the drugs to better understand psychedelics and their mechanisms of action. Among those opposed is the psychedelics company Panacea Plant Sciences; the company has also been outspoken on other DEA proposals to ban other currently unscheduled psychoactive drugs. Panacea Plant Sciences submitted public comment to the current proposal alleging that the DEA’s proposed rule is unconstitutional.

The DEA hearing was announced in early April, and shortly after, Panacea Life Sciences filed suit against the agency. While Panacea’s lawsuit plays out, a DEA judge ordered the hearing be postponed.  

Want the latest psychedelics news? Subscribe! (It’s free!)

Former MAPS employees make troubling allegations

This week, Business Insider reporter Anna Silman published a feature story profiling MAPS and its founder Rick Doblin, and the growing rift between long-time employees and new ones. The piece claims that MAPS’ organizational culture changed as it sought FDA approval for MDMA-assisted therapy for PTSD. If the FDA approves the treatment, MAPS’s for-profit pharmaceutical company, now called Lykos Therapeutics, stands to have the exclusive right to sell prescription MDMA in the U.S. for at least five years. Through conversations with over 50 former and current MAPS employees, the piece describes an unconventional workplace culture, in which power was correlated with closeness to Doblin and some fundraisers involved drug-fueled parties. (MAPS’ communications director Betty Aldworth told Business Insider that the parties “did not represent MAPS’s fundraising strategy.”)

Former staffers also made troubling allegations about the organization’s clinical trials. Some allege that Lykos under-reported adverse events in their clinical trials; in response, Doblin told Business Insider, "I don't feel that's true at all.” Several former employees also alleged that Doblin felt that MAPS “had nothing to apologize for” after a participant named Meghan Buisson was sexually abused by therapists during a MAPS Public Benefit Corp. (now Lykos) clinical trial. According to Business Insider: “When asked about the situation, Doblin told BI that MAPS had provided Buisson with $15,000 to cover her therapy costs and ‘had gone above and beyond what was required of us,’ adding, ‘Whether she's grateful or not is up to her.’”

In Silman’s interviews with former employees, many also spoke of a divide between the “old guard” in MAPS leadership and the organization’s newer employees, which included people from finance, consulting, and pharmaceutical companies. She reports that one compliance officer left the company after just three months. Another newer hire, who also quit, told her: “I need to get out of here if I want to keep my license.” 

According to Business Insider, “Lykos did not comment on specific allegations but told BI that ‘Lykos is confident its design and execution of a clinical development program" for MDMA "addresses the scientific and regulatory requirements to support a marketing application.’”

Alaska psychedelic task force bill passes; California research panel bill advances to senate

Alaska’s Senate passed House Bill 228, which proposes the state form a Mental Health and Psychedelic Medicine Task Force to investigate possibilities for legalizing “psychedelic medicines” at the state level. The task force would also recommend insurance and licensing requirements that would go into effect if the U.S. Food and Drug Administration approves any psychedelic substance as medicine, or if the U.S. Drug Enforcement Administration were to reschedule any of these substances into a less restricted category. The bill now heads to Governor Dunleavy. 

California AB 2841 passed the State Assembly 65-0 last Thursday and moved on to the State Senate. The bill allows the state’s Research Advisory Panel, whose approval must be obtained in order to conduct certain research projects involving Schedule I and II opioid, stimulant, and hallucinogenic drugs, to hold closed sessions. If the bill passes, researchers are hoping it will resolve the state’s current bottleneck in approval of research projects that involve these drugs. The panel used to meet privately, but after changes to state public meetings laws went into effect in 2023, the panel has not met out of fear that private meetings would be a violation of the updated law, while public meetings might reveal applicants’ trade secrets and research ideas. This new bill would create an exception to state law, allowing the panel to discuss applications in closed sessions.

Meanwhile, California Senate Bill 1012, which would have created a state-regulated program to oversee therapeutic uses of psilocybin, MDMA, DMT, and mescaline, has stalled in the Senate Appropriations Committee. In a statement, Senator Scott Wiener, who introduced the bill, called the news disappointing. “We’ve been working for four years to legalize access to psychedelics in California, to bring these substances out of the shadows and into the sunlight, and to improve safety and education around their use,” he said. “I’m highly committed to this issue, and we’ll continue to work on expanding access to psychedelics.”

The nocebo effect

Most discussions about methodology in psychedelics research mention the placebo effect: the possibility that if participants believe a drug will improve their condition, that expectation alone may make it more likely for them to show improvement. But the opposite of that — a “nocebo effect” — has received less attention, yet could be just as important, argues a new paper published in The Journal of Psychedelic Studies. Both placebo and nocebo highlight how participant expectations can shape outcomes. For instance, a nocebo effect might occur if a participant believes that they are in a psychedelics study’s ‘control group’, and did not receive the psychedelic drug, and therefore believes that they will experience less favorable outcomes than if they had received the psychedelic drug. 

The paper’s author, Maria Bălăeţ, also points out that most psychedelics use happens outside of the context of highly regulated, controlled scientific studies and that these expectation effects can influence people’s experiences in recreational use of psychedelics too. “A person exposed to a discourse heavily emphasizing the dangers of psychedelics could experience a nocebo-like response,” she writes. It could even lead to a higher likelihood of adverse events. “Considering the heightened suggestibility during a psychedelic experience, these negative expectations could amplify and result in psychological distress. This distress could persist even after the effects of the drug have worn off.” Bălăeţ suggests that future studies should aim to understand how changes in psychedelics discourse are related to any negative effects people may experience on psychedelics. 

• JJ Wilson, the eldest son of Lululemon’s owner Chip Wilson, has started a psychedelics manufacturing company that might soon be licensed by Health Canada to make medical-grade MDMA and psilocybin, reports The Daily Beast.

• Psychedelic Alpha reports on a new study in which Australian researchers will use MDMA-assisted therapy to treat people with natural-disaster-related PTSD.

• The New York Times reports on the growth of psychedelic churches and U.S. courts’ struggles in defining what constitutes a church.

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.

If you know anyone who might like the latest on psychedelics in their inbox, feel free to forward this to them, or click below.

Got tips? Email us at themicrodose@berkeley.edu.