The US Food and Drug Administration has dealt a “critical blow” to efforts to bring psychedelics into the mainstream, said VoxThe agency rejected an application by drugmaker Lykos Therapeutics to use the drug MDMA – in combination with talk therapy – as a treatment for post-traumatic stress. The rejection “does not completely wipe out the psychedelic movement,” but “it will delay it.”
The rejection came after studies used to support the MDMA effort “missed serious side effects,” according to the Wall Street Journal, and there were issues with bias. The biggest problem? Some subjects told researchers that “their suicidal thoughts got worse during the testing,” raising concerns that this was not fully captured in the study reports, according to the Journal. “The data is reliable,” said Amy Emerson, chief executive of Lykos.
Veterans groups have lobbied for the approval of psychedelics to treat trauma, and their cause has bipartisan support in Congress. For now, at least, that is not enough. “It is clear that the path to creating access to safe, psychedelic-assisted therapies will not go through Washington, DC,” Taylor West of the Healing Action Fund told The New York Times.
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The FDA’s decision will “probably only delay the official introduction of psychedelic medicine” as an approved treatment, Jonathan Lambert said in The Atlantic. But it could spark a change in one of the least understood and most hotly contested issues in psychedelic therapy: the therapy itself. Proponents believe that combining the drugs with talk therapy can “catalyze change” when neither alone can. But determining the effects of a therapy is difficult — and the FDA does not regulate therapy — so drug companies may be tempted to focus only on the drugs’ benefits. That could make psychedelics “just another pill to swallow.”
“Developing psychedelic drugs is inherently a difficult process,” said Benjamin Y. Fong of Arizona State University in an interview with The Conversation. The drugs put users in a “highly altered state” that can ultimately leave them vulnerable. Given that, some observers believe it will be “almost impossible to avoid allegations of wrongdoing” as researchers move forward. They will, but the latest setback shows that psychedelics “face unique obstacles on the road to FDA approval.”
What happens next?
“It is not yet clear” how the FDA’s decision will affect future applications for psychedelic treatments, Nature said. Some advocates fear that future applicants will drop the therapy components of their proposed treatments to get government approval. That would be “contrary to the ethos of many who are pushing for the approval and acceptance of these substances,” said Harvard bioethicist Glenn Cohen.
“Is the medical system ready for any psychedelic?” Time asked. Any drug that is approved will have to overcome “overstretched therapeutic workforces, insurance issues, concerns about safety and illicit use, and logistical problems” to be fully usable in a care setting. Getting MDMA before the FDA took “decades of lobbying.” The final push will continue to be strenuous. Psychedelics are “novel treatments,” said Dr. Jonathan Alpert, chairman of the American Psychiatric Association’s research council, “and they inevitably raise new questions.”
