MDMA-assisted therapy for PTSD has shown promising results in clinical trials since it was first studied in 2011. In 2017, the FDA officially labeled MDMA a “breakthrough drug” for PTSD treatment. In a VICE documentary four years ago, a reporter who’d covered conflict for almost two decades and was diagnosed with PTSD decided to try the treatment himself, citing “remarkable results.”
But after over a decade of study, MDMA still isn’t a legal psychedelic medicine—and this week only laid down more roadblocks.
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On August 9, the FDA denied an application for MDMA treatment from Lykos Therapeutics—which would have been the first of its kind—and requested additional trials to evaluate its safety. Lykos had presented promising data from two late-stage trials showing MDMA’s potential benefits when paired with talk therapy. But, the FDA’s advisory committee raised concerns about trial integrity. One of the biggest roadblocks is that it turns out it’s pretty difficult to convince someone they’ve taken a placebo when they know they’re not on ecstasy because they’re not feeling the high.
On top of all that, a scientific journal called Psychopharmacology retracted three studies on MDMA-assisted PTSD therapy due to “unethical conduct” and conflicts of interest. It’s alleged that some researchers didn’t fully disclose their affiliations with a non-profit research group that is an off-shoot of Lykos. For advocates, it’s a frustrating setback but not a dead end: Lykos says that these problems don’t mean the scientific findings or the data submitted to the FDA is wrong.
Experts in psychedelic psychotherapy, like Rachel Yehuda and Michael Bogenschutz, both quoted in this CNN article, agree that what’s most important for the space is adherence to ethical standards. The treatment needs to undergo these rigorous stress tests to ensure safety before full-on FDA approval.
Lykos says it will request a meeting with the FDA to figure out a path forward.
Watch the VICE doc below:
