The future of psychedelic therapy is at stake as the Food and Drug Administration (FDA) approaches a crucial decision on whether to approve a novel treatment for post-traumatic stress disorder (PTSD) that combines conventional talk therapy with MDMA, a drug commonly associated with rave culture, after more than 50 years of rigorous federal prohibitions.
In the meantime, many groups – including veterans’ organizations, scholars, and an unexpected coalition of legislators, have taken up the cause. Just last week, eighty lawmakers united to write the Biden administration a letter pleading with the FDA to grant Lykos Therapeutics’ application. The hurried effort follows a major setback in June, when a panel of experts unanimously rejected Lykos’s petition, raising questions about the company’s clinical trial procedures and data integrity.
Among the most vocal advocates is Rep. Jack Bergman, a Michigan Republican and former Marine Corps general. Bergman has been instrumental in rallying support, managing to enlist sixty House colleagues in backing the effort. “We’re confronting a severe mental health crisis and a suicide epidemic,” Bergman said. “The FDA needs to consider the real-world consequences of inaction, which could translate into more veterans losing their lives unnecessarily.”
The excitement around the impending ruling indicates how serious and personal the psychedelic medication argument has grown. Psychedelic research centers are being established by prestigious institutions, and the area is receiving substantial funding from private investors. New research indicates that psychedelics, such as LSD, MDMA, and psilocybin mushrooms, may have significant therapeutic advantages for diseases like anxiety and depression that have historically not responded well to traditional therapies. These compounds, however, are still categorized as Schedule I drugs, which means that there is no recognized medical purpose for them and a high potential for misuse, even in light of the mounting evidence.
A recent research that was included in Lykos’s application challenges this stigma. It found that over 86% of participants experienced a significant reduction in PTSD symptoms, with 71% improving to the point where they were no longer diagnosed. This is significantly better than the 69% improvement rate and almost 48% remission seen in the placebo group. Further strengthening the case for approval is that the advantages of MDMA therapy seemed to last for six months after the last dosage.
Dr. David Rabin, a neuroscientist and psychiatrist specializing in psychedelic research, was enthusiastic about the results. “The benefits observed with this therapy are arguably better than any psychiatric medication we’ve had to date,” he remarked. However, the road to approval is not an easy one. The FDA’s advisory panel flagged several issues, including potential for MDMA abuse, possible cardiac risks, and the difficulty of standardizing the psychotherapy component of the treatment.
One notable problem was “functional unblinding,” where participants could often discern whether they had received MDMA or a placebo due to the drug’s potent effects. Dr. Stephen Ross from New York University’s Langone Health Center for Psychedelic Medicine acknowledged that finding a solution to this issue remains a significant challenge in psychedelic research.
The FDA’s decision could have far-reaching implications. A partial approval might necessitate rigorous monitoring and reporting requirements for Lykos, while additional studies could extend the approval process by several years. A rejection, on the other hand, could deter investment and slow progress in the field of psychedelic research.
Juliana Mercer, a Marine Corps veteran and board member of the Heroic Hearts Project, which helps veterans access psychedelic treatments abroad, expressed concerns about the stigma surrounding MDMA. “We just want to ensure that stigma doesn’t influence their decision,” Mercer said. “It would be a tragedy if prejudice prevented a life-saving treatment from reaching those who desperately need it.”
