After more than three decades of planning and a $250 million investment, Lykos Therapeutics’ application for the first psychedelic drug to reach federal regulators was expected to be a shoo-in. Lykos, the corporate arm of a nonprofit dedicated to winning mainstream acceptance of psychedelics, had submitted data to the Food and Drug Administration showing that its groundbreaking treatment for post-traumatic stress disorder — MDMA plus talk therapy — was significantly more effective than existing treatments. At a pivotal public hearing last summer, two dozen scientists, doctors and trauma survivors told an F.D.A. advisory panel how MDMA-assisted therapy had brought marked relief from a mental health condition associated with high rates of suicide, especially among veterans. Then came skeptics with disturbing accusations: that Lykos was “a therapy cult,” that practitioners in its clinical trials had engaged in widespread abuse of participants and that the company had concealed a litany of adverse events.
“The most significant harms in Lykos’s clinical trials were not caused by MDMA, but by the people who were entrusted to supervise its administration,” Neşe Devenot, one of the speakers opposed to Lykos’s treatment and a writing instructor at Johns Hopkins University, told the committee. Dr. Devenot and six others presented themselves as experts in the field of psychedelics, but none had expertise in medicine or therapy. Nor had the speakers disclosed their connection to Psymposia, a leftist advocacy group whose members oppose the commercialization of psychedelics and had been campaigning against Lykos and its nonprofit parent, the Multidisciplinary Association for Psychedelic Studies, or MAPS. The critics did not provide evidence to back their claims of systematic wrongdoing, but when the votes were counted that day, the panel overwhelmingly rejected Lykos’s application. Before voting, panelists cited a number of concerns, among them MDMA’s potential effects on the heart and liver, and whether trial results were influenced by the fact that most study participants correctly guessed they had received the drug and not a placebo. Seven of the 11 panelists mentioned the allegations that Psymposia had raised. One of them, Kim Witczak, a drug safety advocate, said in an interview that the allegations of misconduct had dampened her initial excitement about MDMA. “There were too many things that were red flags for me,” she said. Two months later, the F.D.A. rejected the application. It did not mention the allegations of misconduct or abuse.
“If MDMA was a previously unknown molecule, maybe the burden of proof would be lower, but because these drugs have baggage, the science has to be above reproach,” said Dr. Muñiz, who was not involved in the final review. The significance of Psymposia’s role in torpedoing Lykos’s bid is unclear. But Dr. Muñiz and other experts said the group’s incendiary allegations made approval that much harder. The rejection came as a shock to many in the field. It punctured the air of inevitability about the future of psychedelic medicine and led to a management shake-up and mass layoffs at Lykos and other psychedelic companies. Some have directed their anger at Lykos and MAPS — for fostering unbridled optimism about federal approval and for failing to submit an airtight application to the F.D.A. But in recent months, the story of how a small band of anticapitalist activists helped sink the first psychedelic compound to come before the F.D.A. has captivated scientists, therapists and investors in the field.
It has also generated fear. Buoyed by the F.D.A.’s rejection, Psymposia and its allies have expanded their attacks, including against veterans groups that defended Lykos’s application and psychedelic researchers at Johns Hopkins University. Lykos’s application for MDMA-assisted therapy is not dead. The company met in mid-January with F.D.A. officials to discuss a path forward. Executives said that would most likely include an independent review of its data and another clinical trial that could add years and millions of dollars to the process. Some advocates hope that the Trump administration will take a friendlier approach. They note that Elon Musk, a presidential adviser, and Robert F. Kennedy Jr., the nominee for health secretary, are vocal supporters of psychedelic medicine. Jonathan Lubecky, a retired U.S. Army sergeant and a psychedelic medicine policy advocate, said he believed MDMA would eventually be approved. But he worried about the capacity of Psymposia and its allies to damage a field still in its infancy. He also worries about people with PTSD who have fallen into despair since the F.D.A.’s rejection. “I see the consequences in my friends,” he said. “Some, quite frankly, are trying to decide whether they should stick around long enough to see it happen.”
Despite Psymposia’s modest resources, its members have become feared for their ability to use social media to damage reputations and careers, according to more than four dozen academic researchers, clinicians, industry executives, mental health advocates and former Psymposia members who were interviewed for this article. Many asked not to be named for fear of retaliation. “Even the name Psymposia causes a pang of anxiety,” said Robin Carhart-Harris, a leading psychedelics researcher at the University of California, San Francisco. “Doing this interview, I’m worried: Am I kicking the hornet’s nest?” Another Psymposia activist, David Nickles, describes himself as an underground researcher and an anarchist. Mr. Nickles, whose legal name is David Maliken, according to court documents, has written critically about veterans and the police. In an interview, Mr. Nickles declined to discuss the use of a different name. Ido Hartogsohn, a historian and sociologist of psychedelic science at Bar-Ilan University in Israel, served as a peer reviewer for a paper written by members of Psymposia. He said that the group early on played an important role highlighting abuses in the field but that he had become disenchanted by its tactics. “Psymposia makes some valid points,” he said. “But their work is glaringly political, and biased, and it relies too much on shock effect, bad-faith readings of others and questionable assumptions and assertions.”
“I really felt my whole career was finished,” Dr. Labate said. Oriana Mayorga, Psymposia’s former director of community engagement, said she also experienced the group’s wrath not long after leaving the organization. Ms. Mayorga, who is of Latin American and Caribbean descent, said Psymposia’s leaders sought retribution after she criticized on social media a post by Mr. Nickles that accused MAPS of perpetuating “white supremacy, capitalism and imperialism.” Days later, Mr. Nickles, Dr. Devenot and Lily Kay Ross, who is married to Mr. Nickles, sent a 28-page letter to administrators at the university where Ms. Mayorga was enrolled, accusing her of “discrimination, bullying and intimidation.” The 2020 complaint included transcripts of Ms. Mayorga’s public talks, screenshots from her social media accounts, and text and email messages between Ms. Mayorga and her former colleagues. In an interview, Dr. Ross said that they had contacted Ms. Mayorga’s university to provide her an opportunity “for education and growth.” The letter did not result in disciplinary action, but Ms. Mayorga said the experience was devastating. She largely withdrew from the field and no longer has an online presence.
“They’ve hurt people like me 10 times more than the good work they believe they’ve done,” she said. Psymposia’s reputation was elevated in 2021, when a podcast it produced with New York magazine on abuses in the world of underground psychedelic therapy became popular on Spotify. The podcast highlighted an ethical violation that occurred in an early Lykos trial that was not part of the company’s F.D.A. application, when a husband-wife therapy team in Canada spooned and cuddled a participant, Meaghan Buisson, during her MDMA session. After the trial concluded, the male therapist, Richard Yensen, began a sexual relationship with Ms. Buisson. In 2018, Ms. Buisson filed a civil claim in British Columbia saying that Mr. Yensen had sexually assaulted her. The case was settled out of court. After learning of the violation, MAPS notified health authorities in the United States and Canada and barred the two therapists from its programs. The organization publicly addressed the incident in 2019 in a statement. The podcast did not provide evidence of systemic problems in Lykos’s trials, but it helped fuel rumors of rampant misconduct. Psymposia’s approach had another impact, too: It cleaved the small, close-knit psychedelics community.…Read more by WDC NEWS 6 STAFF