The vote that sank a revolution
August 2024. The FDA rejected MDMA-assisted therapy for PTSD. Lykos Therapeutics — formerly MAPS, a nonprofit that spent $135 million and three decades getting MDMA through trials — watched its Phase 3 data sink. The advisory committee voted 9-2 against. They cited functional unblinding, therapist misconduct at two sites, and inadequate adverse-event tracking. The most promising psychiatric candidate in a generation failed not because it did not work but because the system could not figure out how to evaluate it.
Six months earlier, the mood had been euphoric. Psilocybin trials at Johns Hopkins and Imperial College London were producing results that looked like typos. Treatment-resistant depression patients — people who had failed four, five, six antidepressants — showed sustained remission after one or two supervised sessions. Effect sizes dwarfed SSRIs. Roland Griffiths, who ran the foundational trials before his death in 2023, described watching terminal cancer patients lose their fear of death in a four-hour session.
The rediscovery problem
The backstory makes the results stranger. Psilocybin is not new. Indigenous Mesoamerican communities used it in healing ceremonies for at least three thousand years. Ayahuasca has been central to Amazonian practice for millennia. The clinical world is not discovering these compounds — it is rediscovering them inside a regulatory apparatus requiring the ceremonial context to be stripped away.
The clinical advocates see the rejection as a speed bump — millions suffering from treatment-resistant conditions behind a Schedule I lock. The cautious researchers voted no because they have seen what happens when psychiatric drugs are approved on hype — the benzo crisis, the opioid catastrophe. The prohibitionists consider this time it’s different
the most dangerous sentence in drug policy. And the tradition holders have been watching from a position so old that clinical trials are a blip — their lineages predate the FDA by three thousand years.
Oregon legalized supervised psilocybin in 2020. Colorado followed. Australia reclassified. The clinical train has left the station. Whether it carries the right cargo depends on which group you ask.
Perspectives:
- Clinical advocates
- Cautious researchers
- Prohibitionists
- Tradition holders