Over the last few weeks, the federal government has taken a number of actions that signal a dark future for psychedelic therapies. Today we'll take a quick look at what's happened, and what may happen in the future.
FDA gives thumbs down to MDMA
Earlier in August, the FDA opted not to approve Lykos Therapeutics' MDMA drug for treatment of post-traumatic stress disorder (PTSD). This followed on a June 2024 meeting in which an advisory committee refused to recommend FDA's approval of the drug, ostensibly because there was not sufficient safety and efficacy data (you can read a report on that decision here).
Meanwhile, after the FDA decision was made public, a scientific journal retracted three MDMA-assisted therapy articles reportedly due to unethical conduct not disclosed prior to publication. The retracting journal's rationale was that some of the authors allegedly failed to disclose their affiliation with the Multidisciplinary Association for Psychedelic Studies (MAPS) or its affiliates. Lykos is, notably, the rebranded name of MAPS PBC.
Lykos apparently plans to ask FDA to reconsider the decision, but it still faces an uphill battle.
Enforcement in the ketamine industry
On August 15, 2024, the United States Attorney for the Central District of California announced charges against five individuals who were allegedly involved in providing ketamine to deceased actor Matthew Perry. Two of the charged individuals are physicians. According to the charging announcement, one of the physicians operated a ketamine clinic.
Then, just a few days later, DEA administrator Anne Milgram appeared on Face the Nation to discuss the Perry charges. During the interview, Milgram compared ketamine abuse to the beginning of the opioid epidemic, and said (emphasis added):
At DEA what we're focused on, we're focused on doctors, nurse practitioners, anyone who is essentially diverting legitimate controlled substances from the normal medical practice to do what we saw happening here, where doctors, these doctors, were not evaluating Matthew Perry, they were not supervising injections. They were leaving behind vials of ketamine for Matthew Perry to be injected by his assistant. And so again, we're focused on the controlled substance side, but we every single day, are targeting and investigating doctors, nurse practitioners, others who are violating this duty of trust to their patients by over prescribing medicine or prescribing medicine that isn't necessary.
The claim that DEA is targeting physicians every day seems like a stretch, although the DEA has shut down clinics in the past. For example, the DEA apparently revoked a South Carolina doctor's permission to prescribe controlled substances in 2023, though the specific circumstances of the revocation were unclear.
The point here though is that Matthew Perry's death shone a light on the ketamine clinic industry, which is now in a new phase of potential enforcement from the federal government. Clinics and physicians must understand that operating outside of the bounds of federal and state laws might lead to criminal charges and convictions.
What about other psychedelics?
We've looked at MDMA and ketamine – which some would argue are not even actually psychedelics – but what about things like psilocybin, etc.?
From a federal perspective, not a lot has changed recently. We still don't have a federal psychedelics "Cole Memo," meaning operators under Oregon's Measure 109 program are operating with a lot more risk than, say, a cannabis company in 2015.
At the same time, other psychedelic formulations are still winding their way through the tedious FDA approval process, including psilocybin. It's certainly possible that a psilocybin-based drug is approved in the next few years, but with what just happened to MDMA, the future looks far less promising.
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