Lawmakers in both parties are pushing for approval of a new treatment for veterans suffering from PTSD that pairs therapy with a psychedelic drug, but opponents warn that the treatment could do more harm than good and hinder future approvals.
The Food and Drug Administration is slated to decide whether to approve a psychotherapy treatment from California-based Lykos Therapeutics that pairs therapy with MDMA, also known as ecstasy, by Sunday.
If the agency approves the treatment, it would be the first of its kind in the U.S., and could pave the way for future therapies that incorporate other psychedelics, like LSD or psilocybin. Lawmakers and veterans’ advocacy groups argue that pairing therapy with the drug could help to reduce the number of veteran suicides in the U.S.
According to a report published by the VA last year that compiled satistics of suicides among veterans in 2021, 6,392 veterans took their own lives — an average of roughly 127 per day. Since 2001, nearly 150,000 veterans have committed suicide.
Sen. Michael Bennet, Colorado Democrat, and 19 Republican and Democratic senators argued in a letter to FDA commissioner Robert Califf this week that the latest trial phase of the cutting-edge, MDMA-assisted therapy proved promising in aiding veterans suffering from PTSD.
“If comprehensive evidence demonstrates that MDMA-AT is both effective and safe when administered in appropriate settings, it is our responsibility to ensure that this treatment option is made available to those who could benefit from it,” the lawmakers wrote.
But the approval of Lykos’ treatment hit a snag in June when an FDA advisory panel overwhelmingly voted against recommending it for approval.
Advisory panel members raised concerns with allegations of ethical and sexual misconduct during treatment sessions, weak data and overall questions about long-term health effects and addictiveness from the usage of MDMA. The panel based its decision on data from two trials of roughly 200 participants with PTSD.
The FDA does not have to follow the recommendation from the panel, but typically the agency does not stray from a panel’s opinion during its decision-making process.
“I have real concerns with the validity of the data and the allegations of misconduct,” said committee member Kim Witczak at the time. “I can’t in good conscience support something where this many harms are being reported and just say, ’Oh, someone somewhere is investigating it.’”
Lykos’ push for approval took a hit early on when, in 2015, trial participant Meaghan Buisson was pinned down, cuddled and stroked by therapists, as seen in a video first reported by New York Magazine.
But in a letter to President Biden this week, Rep. Jack Bergman, Michigan Republican, and 61 House Republicans and Democrats contended that the therapy could be the key to lowering the veteran suicide rate.
If approved, the therapy would also be the first new treatment for PTSD authorized by the FDA in over two decades.
“This astounding lack of innovation has undoubtedly contributed to our rising veteran suicide rates over the past two decades,” the lawmakers wrote.
They noted that in the latest phase of the treatment’s trial, more than 71% of participants no longer qualified for a PTSD diagnosis after three eight-hour sessions of treatment, while more than 86% of participants experienced “clinically significant” improvements in their PTSD symptoms.
Lori Tipton, a participant in the therapy trials, told The Washington Times that she struggled with PTSD for over a decade stemming from a series of traumatic events in her life, including the loss of her brother to an overdose, her mother’s suicide after murdering two people, and then the carnage produced from Hurricane Katrina in her home of New Orleans.
Ms. Tipton said her life was filled with anxiety, mood swings, panic attacks and suicidal ideations before her MDMA-assisted treatment.
“While I wouldn’t claim that MDMA-assisted therapy completely eradicated my PTSD, upon completing the trial in 2018, I no longer met the diagnostic criteria, and that remains true today,” Ms. Tipton said.
A group of 730 veterans and veterans organizations urged the FDA to give Lykos’ treatment a chance, writing in a letter to the Biden administration that while PTSD affects millions of Americans, veterans are disproportionately affected and that if the agency were to approve the therapy method, it would be “amongst the most invaluable treatments ever developed.”
Neșe Devenot, who has been outspoken against Lykos’ treatment, is a board member at Psymposia, a nonprofit leftist media outlet that advocates for psychedelic therapies and is strongly opposed to the company’s MDMA-assisted therapy.
Devenot, who uses they/she pronouns, told The Times that concerns with Lykos’ methodology outweigh the benefits that could stem from the FDA approving the treatment, and warned that approval could do more harm than good for future approvals of psychedelic treatments for PTSD.
“No one’s saying that veterans shouldn’t deserve access to treatments that work,” Devenot said. “We’re saying that we need to be sure that the treatments that we’re offering people are going to be safe and effective. In this case, the therapy model of Lykos, they were not even honest with the FDA about what they were doing.”
Lykos CEO Amy Emerson told The Times that accusations that the company misled the FDA were false, and said that across years of trials, Lykos worked hand-in-hand with the agency to ensure consistency in their testing.
Ms. Emerson acknowledged that Lykos would not deny that there was misconduct in 2015, and called the incident “horrible.”
But, she said the latest wave of criticism against Lykos’ therapy model was not unusual, adding that “there’s a lot of fears that come out when you’re about to do something innovative and new.”
“The evidence that we have is strong, and if there are a few more questions that we have to answer, so be it,” she said.
• Alex Miller can be reached at amiller@washingtontimes.com.
Please read our comment policy before commenting.