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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.
In a confidential letter to Lykos, the agency said its decision was based on uncertainty about how long the treatment would be effective; concerns about positive bias, including previous use of MDMA by some participants; and Lykos’s failure to collect data on feelings of euphoria, which is considered an adverse event because it can signal a potential for abuse. The letter was described by people who had read it.
An F.D.A. spokesperson declined to comment, saying the agency does not discuss pending applications.
Dr. Javier Muñiz, the former associate director of therapeutic review at the F.D.A.’s division of psychiatry who helped Lykos design its trials, said the treatment’s talk therapy component was a challenge for the agency because it does not regulate psychotherapy.
He also cited another factor: the cultural stigma of an illegal drug commonly associated with cuddle puddles and all-night raves.
“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 accusations had contributed to the panel’s skepticism.
The F.D.A. agreed to extend the hearing.
Of the 32 speakers, 10 opposed Lykos’s application. Seven of those 10 were affiliated with Psymposia, though none mentioned their connection to the group.
During the daylong meeting, panelists repeatedly raised questions about Psymposia’s misconduct claims.
One advisory member voted in favor of Lykos’s application — the sole panelist with expertise in psychedelic medicine.
Even though Psymposia did not provide evidence to back up its allegations of widespread wrongdoing, Amy Emerson, the former chief executive of Lykos, said the speakers succeeded in shaping the narrative.
“They were able to prey on the fears of people in government who care about reputational risk,” she said. Ms. Emerson resigned shortly after the F.D.A. denied approval.
In their public testimony, Dr. Devenot repeated an explosive accusation they had shared with ICER: One of the therapists who took part in Lykos’s clinical trials, Veronika Gold, had admitted to pinning down a screaming patient.
But the incident, detailed in a book chapter Ms. Gold wrote, involved ketamine, not MDMA. And rather than being “pinned down,” Ms. Gold said the patient was consensually pushing against her hands, which were passively raised.
Dr. Devenot also testified that Ms. Gold had used a similar practice with a clinical trial participant. Ms. Gold said the incident did not happen, a claim backed up by Lykos, which said it reviewed videos of her therapy sessions.
The accusations, repeated in the media, were damaging, she said. “People have expressed concerns about my ethics and practice,” Ms. Gold said.
Concerns about the organization’s ability to disrupt the field have mounted in recent months after a public relations firm began amplifying Psymposia’s and Dr. Devenot’s allegations of malpractice against Lykos. Dr. Devenot declined to say who was funding the group’s work.
Another longtime Psymposia ally, Sasha Sisko, has been pressuring academic journals to retract studies based on Lykos’s clinical trials. In August, the journal Psychopharmacology retracted three studies that contained data from the session with Ms. Buisson.
Lykos disagreed with Psychopharmacology’s decision, saying a correction to the papers would have sufficed.
Mx. Sisko, who uses gender-neutral pronouns, has also criticized Lykos trial participants who have spoken favorably about their experiences.
Becca Kacanda, who posted about her treatment on X, said Mx. Sisko criticized her on the platform and wrote in a direct message that she had undergone a “whack-a-doodle nonsense ‘therapy.’”
Ms. Kacanda said Mx. Sisko seemed to be fishing for information to use against Lykos and trying to “gaslight” her about her trial experience.
“I am not trying to silence cases of abuse or constructive critiques,” Ms. Kacanda said. “But Psymposia does not have the good faith intentions that they are presenting themselves to have.”
Mx. Sisko declined to be interviewed on the record for this article.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their own group.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.
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