High hopes that MDMA therapy would be legalized this summer were deflated on Tuesday after an FDA advisory panel voted overwhelmingly against the drug’s approval as a treatment for PTSD. The public hearing was held by an independent committee of advisers, and its vote is non-binding, but will likely influence the FDA’s official decision expected in mid-August. The panel voted 9-2 against endorsing the efficacy of MDMA-assisted therapy, and 10-1 rejecting the question of whether the benefits outweighed its risks.
Members of the panel critiqued the designs of the two studies submitted by the drug’s sponsor, Lykos Therapeutics, expressing concerns that the integrity of the trials’ impressive results had been compromised by biases and design flaws. Experts also cited as reasons for their “no” vote significant drug risks like the potential for heart problems and abuse, a controversial case of therapist misconduct, and the lack of diversity amongst the participant pool, with only five Black patients receiving MDMA.
Concerns over Lykos’ data have been brewing for several years; in March, a nonprofit called the Institute for Clinical and Economic Review, or ICER, published a report that highlighted many of the problems that resurfaced during the public hearing. Some of the issues weighed by the experts are particularly complex. A persistent challenge that psychedelic researchers face is that participants are usually able to tell if they received a placebo instead of an active compound, which is known as “functional unblinding” and can substantially skew the results. Another intractable issue is that the FDA does not regulate psychotherapy, and has never evaluated drugs like MDMA, whose efficacy is pinned to its use in conjunction with talk therapy.
READ: More Patients Could Have Access to MDMA Therapy—Before the FDA Approves It
Citing the numerous flaws in trial design, committee chair and University of Pittsburgh psychiatry professor Rajesh Narendran described the data as “meaningless.” Panelist and sociologist Elizabeth Joniak-Grant, who also cast a “no” vote, admitted that it was a difficult decision because she saw the potential in the treatment, but was concerned that 40 percent of participants already had prior experiences with MDMA outside the Lykos trials. “The large positive effect was denuded by significant confounders. It just needs to be better studied,” said panelist Maryann Amirshahi, a professor of emergency medicine at Georgetown University School of Medicine.
Tuesday’s “no” vote was a major setback for Lykos Therapeutics, the corporate spinoff of MAPS—the organization that has been spearheading the movement to legalize MDMA since it was founded in 1986. MAPS founder Rick Doblin’s perceived evangelism came under scrutiny during the public comment period held just before the vote, with Brian Pace, a lecturer at Ohio State University, describing Lykos as a “therapy cult” seeking “global spiritual conversion” via psychedelics.
Pace’s involvement in the meeting was expected, given that he and Dr. Neşe Devenot, a senior lecturer at Johns Hopkins University, are long-standing critics of MAPS—and collaborators at Psymposia. In fact, they are largely responsible for getting this week’s committee hearing extended and, in effect, notifying the general public about it. In March, Devenot and a cohort of “concerned citizens” petitioned the FDA to arrange an advisory committee session where the public could voice their concerns and opinions regarding the prospect of MDMA‘s approval.
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READ: Petition Urges FDA to Review Risks of Lykos Therapeutics’ Bid for Legal MDMA
“We hold serious concern that these allegations of entrapment, sexual abuse, and coercive control are directly connected to the organizational culture and psycho-spiritual beliefs around ‘healing’ that are encoded in the MAPS/Lykos protocol,” the petitioners wrote. “This is a high-stakes decision with significant consequences. A public advisory committee meeting is essential to preserve the FDA’s mandate of protecting and promoting public health. As such, we call for the FDA to organize an advisory meeting for MDMA-assisted therapy with an extended open public hearing.”
Despite the committee’s rejection, many industry insiders reacted to the news with measured optimism. “I feel confident that Lykos can course correct,” said clinical pharmacologist Stephanie Karzon Abrams, Founding Advisor at psychedelic consultancy Beyond the Bench. “How much time will it take to do that and satisfy the FDA? That’s another question.”
The FDA’s decision in August will ultimately serve as a moment of truth for the psychedelic legalization movement, while setting a precedent for ongoing efforts to legalize other psychedelics like psilocybin mushrooms. FDA approval of MDMA has been described as a “backdoor” to legalization because it would likely force the DEA to reschedule the drug from Schedule I (no approved medical use) to Schedule II or III. However, the committee’s “no” vote demonstrated the messiness of psychedelic clinical trials and the unparalleled regulatory challenges they pose.
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