A first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for post-traumatic stress disorder (PTSD) in the US was criticised on Tuesday by a panel of experts.
In what could be a major setback to advocates hoping to win federal approval for medical psychedelics, a panel of advisers to the Food and Drug Administration (FDA) voted 10-1 against the overall benefits of MDMA when used to treat PTSD.
“It seems like there are so many problems with the data - each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have about how effective the treatment is,” said Dr Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.
Methylenedioxymethamphetamine, commonly known as MDMA or molly, triggers feelings of intimacy, connection, and euphoria. When used to enhance talk therapy, the drug appears to help patients process their trauma and let go of disturbing thoughts and memories.
Flawed and unreliable data
But panellists cited risks, including for heart problems, injury and abuse. They also pointed to flawed or unreliable study data due to a lack of diversity among patients, the difficulty of knowing whether patients were improving due to MDMA only, and previous recreational use of MDMA by some patients.
Almost all patients in two key studies of the drug were able to guess whether they had received the MDMA or a dummy pill. This goes against the approach generally required for high-quality drug research, in which bias is minimised by “blinding” patients and researchers to whether they received the drug under investigation.
“I’m not convinced at all that this drug is effective based on the data I saw,” said Dr Rajesh Narendran, a University of Pittsburgh psychiatrist who chaired the panel.
The FDA is not required to follow the group’s advice and is expected to make its final decision by August 11.
The resurgence of psychedelics
Lykos Therapeutics, the company behind the study, said in a statement after the meeting where veterans benefitting from MDMA and medical professionals advising against its use also testified, that it would work with regulators to address the panel's concerns.
“While we are disappointed in the vote, we are committed to continuing to collaborate with the FDA with their ongoing review of our (drug application) over the coming weeks,” the company stated.
Lykos was founded by the leading psychedelic advocacy group Multidisciplinary Association for Psychedelic Studies (MAPS), set up in 1986.
In April, the company's European programme completed Phase 2 of its two-year study for the use of MDMA for adults with PTSD.
The study included 21 participants treated in the Czech Republic, Germany, the Netherlands, Norway and the United Kingdom.
"Given the substantial need for new treatment options for individuals with mental health conditions in Europe, the completion of this Phase 2 study is an important step to helping address unmet needs outside the United States," said Amy Emerson, chief executive officer at Lykos Therapeutics.
The tests are part of a wider resurgence of interest in the medical potential of treatments using psychedelics such as LSD, Ketamine and psilocybin mushrooms for conditions like depression and addiction.
