This article discusses suicide. If you or someone you know is considering suicide, please contact the Suicide and Crisis Lifeline at 988 or 1-800-273-TALK (8255).
A U.S. Food and Drug Administration (FDA) panel has rejected an MDMA-based treatment for post-traumatic stress disorder (PTSD) that is often used to treat military veterans.
On June 4, the advisory committee voted 10-1 against the overall benefits of using MDMA to treat PTSD, according to the Associated Press.
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During a nine-hour hearing in Silver Spring, Maryland, the committee raised concerns about flaws in the studies, unclear data and potentially harmful side effects before again voting 9-2 against the drug’s effectiveness.
A drug application for psychedelic-assisted therapy was submitted by Lycos Therapeutics, Inc. of California, earlier this year.
“When I heard the verdict, all I could think about was how the veterans’ hopes have been dashed and there is no solution,” one advocate said. (iStock)
The company expressed disappointment with the FDA’s decision in a June 4 statement.
“We are disappointed with the outcome of today’s vote given the urgent unmet need for PTSD. We appreciate the Committee faced the difficult and unusual challenge of evaluating a treatment that combines a medication (MDMA) with a psychological intervention,” said Amy Emerson, CEO of Lycos Therapeutics.
“Given the urgent unmet need, we are disappointed with today’s vote.”
“We look forward to working with the FDA to address any outstanding issues so that we can find a path forward to ensure that MDMA-assisted therapy, if approved, is introduced into the health care system responsibly and carefully.”
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In a statement to Fox News Digital, the FDA reiterated its intention to continue reviewing drug applications.
“The FDA appreciates the input from the Psychopharmacological Drugs Advisory Committee,” an FDA spokesperson said in an email. “Following the meeting, FDA professional staff will continue their review of the new drug application, taking into account the committee’s input.”
An FDA panel has rejected an MDMA-based treatment for post-traumatic stress disorder (PTSD) that is often used to treat military veterans. (iStock)
Juliana Mercer, who served in the Marines for 16 years and is director of the San Diego-based nonprofit Healing Breakthrough, is a leading advocate of psychedelic medication in treating mental health issues.
In an interview with Fox News Digital, Mercer said the verdict came as a “huge shock.”
She added: “When I heard the verdict, all I could think about was that the hopes of veterans had been dashed and there was no solution.”
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“There are a number of large veterans organizations that share a common understanding that there is a great need for solutions to PTSD,” Mercer said at the hearing.
“Some veterans who have received this treatment have spoken about how it saved their lives,” she added.
Pictured here is Julianna Mercer, a US Marine who was deployed to Helmand province in Afghanistan in 2010. Now a veteran, she too struggled with PTSD. (Julianna Mercer)
One Marine Corps veteran told the panel about receiving calls from veterans asking, “How do I get this treatment?”
“I’ve been getting those same calls,” Mercer said. “Veterans have heard this works. They’ve seen the data and the science, and they were eager to get this approved.”
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Following the verdict, Mercer said: “My heart broke for the veterans who testified. It took me about 48 hours to go from grief to the realisation that I had an uphill battle ahead of me, and I was prepared to do whatever it took to win this battle.”
Juliana Mercer, pictured, testified in support of psychedelic therapy before the House Veterans Affairs Committee in November 2023. (Julianna Mercer)
Mercer noted that conversations with the advisory committee have pivoted from data and facts to “conversations about substance abuse, integrity and motivation.”
“They’re basically saying there’s not enough data and facts to approve it,” she said. “This is the first time that something based on science and data has actually emerged to actually cure or remove the diagnosis of PTSD, and they refuse to look at it.”
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Mercer said he was “hopeful” the decision would be overturned: “There haven’t been any new drugs for PTSD in over 20 years, and the ones we have aren’t as effective as we’d like them to be.”
“There are significant downsides to unregulated recreational use.”
“We are losing more than 6,000 veterans a year. Since the start of the Global War on Terror in 2001, more than 130,000 veterans have died by suicide here in the United States.”
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According to Mercer, the VA currently has 13 MDMA-based trials ongoing.
The FDA said the decision is not final and that it will continue to work with Lycos Therapeutics to address concerns until a new decision deadline of Aug. 9.
Both MDMA and psilocybin-assisted therapy (also known as ecstasy or magic mushrooms) will be studied by the VA. (iStock)
In a statement to Fox News Digital, VA spokesman Terrence Hayes said the Washington, D.C., department is “closely” monitoring the FDA’s decision but “cannot comment on FDA advisory committee recommendations or the FDA’s pending decisions regarding new drug applications.”
“VA is committed to high-quality research that safely advances the health of our nation’s veterans,” Hayes wrote.
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“In line with this goal, as announced in January, VA will be conducting additional studies under rigorous protocols at various facilities to evaluate whether psychotherapy combined with compounds such as MDMA and psilocybin is effective in treating veterans suffering from post-traumatic stress disorder and other psychiatric illnesses.”
“More than 6,000 veterans die every year,” one activist said. “More than 130,000 veterans have died by suicide in the United States since the global war on terror began in 2001.” (iStock)
Hayes added that VA may provide agency research funding for larger studies investigating these new treatments, including new ways of administering the treatments, aimed at maximizing benefit and minimizing risk to veterans.
Dr. Mark Siegel, Professor of Clinical Medicine NYU Langone Medical Center He is also a medical correspondent for Fox News and interviewed two of the country’s leading researchers on psychedelics.
Earlier this year, he spoke with Dr. Rachel Yehuda, founder and director of the Center for Psychedelic Psychotherapy and Trauma Studies at Mount Sinai in New York, and Dr. Charles Marmer, director of the PTSD Research Program at NYU Langone.
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“Researchers agree that there could be therapeutic value if studied carefully under very strict medical supervision, but there are significant downsides to unregulated recreational use,” Siegel told Fox News Digital at the time.
“Both doctors believe that psychedelics can have therapeutic value if carefully supervised by medical professionals.”
