Critics of Lykos’ MDMA Trials come out in force at meeting as FDA denies approval request

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Concerns were raised about the reliability of the data and potential safety risks associated with the drug.

A panel of federal health advisers convened Tuesday to consider a landmark proposal to approve MDMA as a treatment for post-traumatic stress disorder. In the end, Lykos’ MDMA drug approval proposal to treat PTSD failed with a 2-9 vote, preventing a chance at federal approval later this summer.

The Food and Drug Administration panel reviewed the latest research on MDMA, from studies conducted by Lykos Therapeutics, a spinoff of the Multidisciplinary Association for Psychedelic Studies (MAPS). During the trials, patients who received MDMA as part of an intensive, four-month course of talk therapy reportedly experienced significantly lower PTSD scores versus those who did not receive the drug, according to data presented to the panel.

However, the agency expressed concerns about the reliability of the data and potential safety risks associated with the drug, including heart problems and the potential for abuse. In addition, critics of the trials themselves cam out in force to participate in the public comment portion of the meeting.

“This application is both consequential and complex,” FDA reviewer Dr. Tiffany R. Farchione noted at the beginning of Tuesday’s meeting.

Red flags

While taking public statements, the panel heard from a diverse range of stakeholders, including veterans, mental health professionals, researchers, and individuals with personal experiences related to PTSD and MDMA therapy.

Supporters of the therapeutic use of MDMA included Brian Dempsey from the Wounded Warrior Project, who advocated for the potential of MDMA-assisted psychotherapy to help veterans with PTSD, citing the high prevalence of the condition and the need for innovative treatments.

Deran Young from Black Therapist Rock also advocated for the potential of MDMA-assisted therapy to address racial trauma.

“Compared to psychedelic assisted therapy, which is like riding a motorcycle in terms of racial trauma, MDMA assisted therapies offers a significant beacon of hope,” Young said.

Still, red flags regarding Lykos’ leadership and clinical model were laid out during the hearing.

Meghan Poisson, a phase 2 clinical trial participant recruited by Lykos, shared her traumatic experience during the trial. In a statement read by proxy Sarah Grosch, Poisson alleged that she was subjected to physical and sexual assaults during MDMA-assisted therapy sessions, despite not consenting to being “blindfolded, gagged, pinned, cuddled, and caressed.” Poisson also claimed that she became suicidal during the trial, but Lykos failed to document this adverse event.

“The clinical trial shattered me. Overwhelmingly vulnerable, I was trafficked by my therapist while still in the clinical trial,” Poisson said. She urged the FDA to seriously consider its responsibility for patient safety and to reconsider the veracity of Lykos’ claims.

Independent investigative journalist Sasha Sisko, a survivor of PTSD, raised several concerns about alleged misconduct by Lykos and its founder, Richard Doblin. Sisko highlighted incidents such as the assault of Poisson, proposals to enroll Ukrainian refugees in MDMA-assisted group therapy trials, and the promotion of off-label use of MDMA-assisted couples therapy.

Journalist Russell Hausfeld, who has followed Lykos Therapeutics for years, raised concerns about the company’s handling of clinical trial data and alleged mistreatment of participants. One veteran quoted by Hausfeld said, “I watched as Lykos and its researchers used veterans up and discarded them as soon as they no longer served a useful purpose, regardless of mental health consequences or social implications.”

Bo Wittka, who experienced severe symptoms following a guided MDMA therapy session, stressed the importance of proper therapist training and patient support.

“The frightening state I am in, and if I learned to cope with to the best of my ability, began immediately following a single guided MDMA assisted therapy session on Feb. 19, 2023,” Wittka stated, adding, “There is zero support for people like me and absolutely no safety net in place.”

Former members of the psychedelic research community, including the Rev. Joe Welker, who heads a Presbyterian congregation in Vermont, alleged that Lykos leadership used the MDMA trials to advance a religious and spiritual agenda, with instances of abuse and misconduct against trial participants.

“While Lykos leadership may envision a spiritualized humanity, in this very study, Lykos treated the people who were harmed under their care with a falsely spiritual inhumanity,” Welker said.

If ultimately approved, MDMA would become the first illegal psychedelic substance to gain mainstream medical acceptance.

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