The U.S. Food and Drug Administration has delivered a "critical blow" against efforts to bring psychedelics into the mainstream, said Vox .
The agency rejected an application from drugmaker Lykos Therapeutics to use the drug MDMA as a treatment — combined with talk therapy — for post-traumatic stress. The rejection "does not fully quash" the psychedelic movement, but "it will delay it." The dismissal came after studies used to support the MDMA effort "missed serious side effects," The Wall Street Journal said, and had problems with bias.
The biggest problem? Some subjects told researchers "their thoughts of suicide worsened" amidst the testing, raising concerns the Journal said were not fully captured in the trial reports. "The data is reliable," said Lykos chief executive Amy Emerson. Veterans groups have pushed for approval of psychedelics to treat trauma issues, and their cause has bipartisan support in Congress.
For now, at least, that is not enough. "It's clear that the path to creating access to safe, psychedelic-assisted therapy is not going to run through Washington, D.C.
," Healing Action Fund's Taylor West said to The New York Times . What did the commentators say? The FDA's decision "will likely only delay psychedelic medicine's official debut" as an approved treatment, Jonathan Lambert said in The Atlantic . But it could prompt a change in one of the most "poorly understood and hotly contested" issues in psychedelic therapy: the therapy itself.
Advocates believe combining the drugs with talk therapy can "catalyze changes" neither accomplishes on its own. Sussing out the effects of therapy is difficult, though — and the FDA does not regulate therapy — which is why drug companies may be tempted simply to focus on the benefit of drugs alone. That could turn psychedelics "into just more pills to pop.
" "Psychedelic drug development is a fraught process by nature," Arizona State University's Benjamin Y. Fong said in an interview with The Conversation . The drugs do put users in a "severely altered state" that can render them vulnerable, after all.
Given that, some observers believe it will be "nearly impossible to avoid accusations of impropriety" as researchers make their way forward. They will venture ahead, but the latest setback shows how psychedelics face "unique obstacles on the way to FDA approval." What next? "It's not yet clear" how the FDA decision will affect future applications for psychedelic treatments, said Nature .
Some advocates worry that future applicants will drop the therapy components of their proposed treatments in order to get government approval. That would be "contrary to the ethos of many who have been pressing for approval and acceptance of these substances," said Harvard bioethics expert Glenn Cohen. "Is the medical system ready for any psychedelic?" asked Time .
Any drug that does get approval will have to overcome an "overstretched therapeutic workforce, insurance headaches, concerns about safety and illicit use and logistical issues" to be fully implemented in a care setting. Getting MDMA in front of the FDA took "decades of advocacy." The final push will remain strenuous.
Psychedelics are "novel treatments," said Dr. Jonathan Alpert, chair of the American Psychiatric Association's Council on Research, "and they inevitably raise novel questions.".
