In what could be a pivotal moment for the future of psychedelic medicine, the Food & Drug Administration (FDA) is weighing a decision to approve MDMA-AT, also known as ecstasy or molly, to treat post-traumatic stress disorder.
The FDA is expected to make a decision by Aug. 11.
The decision will have a huge impact on military veterans who say the psychedelic drug has relieved their PTSD symptoms. Psychiatrists combine their therapy sessions with the psychedelic medicine.
"I have not seen a medicine this powerful in a long time," Dr. Manish Agrawal, the CEO of Sunstone Therapies, told Fox News.
MARINE VET TOUTS BENEFITS OF PSYCHEDELIC-ASSISTED PTSD DRUGS AS FDA CONSIDERS MDMA APPROVAL
Both MDMA and psilocybin-assisted therapies, also known as ecstasy and magic mushrooms, will be studied by the VA. (iStock)
"MDMA allows people to access parts of their trauma that are deeply seated that they've not been able to access with traditional therapy while in a loving and supporting and safe environment," Agrawal said.
Sunstone is participating in an Expanded Access Program that allows it to treat a limited number of patients with MDMA-assisted therapy at its site in Rockville, Maryland. Sunstone did not participate in the Lykos' Phase II or III clinical trials that are being evaluated by the FDA.
"You need a purpose-built space. You need highly skilled, trained therapists and staff. … If MDMA cured PTSD, then everybody that goes to a rave wouldn't have trauma anymore," Agrawal said.
"It's not a magic bullet. It does not work for everyone. But I have seen people really change."
Jonathan Lubecky is a retired Army sergeant who has been treated with MDMA. Lubecky has had a long battle with PTSD. He attempted suicide on Christmas morning in 2006, 60 days after returning home from Iraq. Lubecky found the Lykos trial in Charleston during hospitalization after eight years of struggling and several more suicide attempts.
"I took my first dose of MDMA, only taking it three times as part of the clinical trial. I haven't taken it since. I haven't found the need to take it since because I haven't had PTSD since," Lubecky told Fox News.
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Jonathan Lubecky, a retired Army sergeant who has volunteered as a medic in Ukraine, found the Lykos trial in Charleston during hospitalization after eight years of struggling and several suicide attempts. (Courtesy of Jonathan Lubecky)
Now, Lubecky hopes the FDA will approve the use of MDMA so other veterans like him can get the treatment they need.
"I keep hope because the FDA will approve this, if not on Aug. 11, one day they will. The only question for the FDA is how many veterans, how many Americans' lives, between now and then?" Lubecky said.
Last month, Lubecky joined a chorus of veterans on Capitol Hill to raise awareness about MDMA treatment.
Veterans built a heaping memorial out of dog tags to honor the 17 veterans who die by suicide every day and the 13 million Americans who suffer from PTSD, including 7% of veterans.
Veterans and lawmakers gather on Capitol Hill to dedicate a Dog Tag Memorial to the 17 veterans who commit suicide each day. (Fox News Channel )
Veterans seeking help are traveling outside the U.S. and taking on personal debt to undergo psychedelic-assisted therapy. Heroic Hearts Project helps connect veterans with such overseas services. Founder and President Jesse Gould said the irony is not lost on him.
"The FDA alone holds the key to granting veterans this access to MDMA assisted-therapy. And approving this treatment is not just a formality. It is literally a lifeline for this nation's veterans," Gould said.
More than 60 bipartisan lawmakers have written to the Biden administration urging its approval of MDMA.
"Thousands of Veterans suffering from PTSD continue to take their lives each year. Current treatments clearly are not working well enough, and our Veterans can no longer wait," the lawmakers warned in a letter.
Among the lawmakers backing approval is Texas Republican Rep. Morgan Luttrell, who was medically retired because of a traumatic brain injury after serving 14 years as a Navy SEAL.
"The term psychedelics scares people. It scared me too," Luttrell told Fox News. He described his personal journey on psychedelics as "nothing short of an exorcism."
"It allows you to address things that, you know, live and breathe and repress back in a deep cognitive spaces of your brain. And that's usually what people need," Luttrell said, describing the treatment as 20 years of therapy in three days.
Texas Rep. Morgan Luttrell, who was medically retired for a traumatic brain injury after serving 14 years as a Navy SEAL (Courtesy of Rep. Morgan Lutrell)
Juliana Mercer is a Marine Corps veteran and founder of Healing Breakthrough, a nonprofit that works alongside Heroic Hearts Project. After she was treated, she felt a load had been lifted.
"I woke up the next day, and I was joyful. And I had love in my heart for myself and for others and had a completely new outlook and really was connected to my authentic self for the first time in a really long time," Mercer said.
According to the Multidisciplinary Association for Psychedelic Studies, MDMA studies found that 67% of participants no longer met the criteria for PTSD two months after concluding their sessions.
Despite these positive reviews, the FDA’s advisory committee voted MDMA down last month. Kim Witczak, a consumer representative who sits on the committee and voted no, spoke with Fox News about her decision.
"There were clinical participants as well as investigators and former Lykos employees that came forward and said that there could have been issues with selection bias," Witczak said.
Witczak cited safety concerns and public pressure campaigns targeting lawmakers. Rushing drugs to the market could lead to a lengthy and dangerous process of retracting them if they are found to be unsafe later, Witczak explained.
FDA PANEL REJECTS MDMA-ASSISTED THERAPIES FOR PTSD DESPITE HIGH HOPES FROM VETERANS
MDMA pills (Fox News Channel)
"My message to the FDA would be when you have allegations, you must investigate. ... Once the genie's out of the bottle, it is too late to try to put it back," Witczak said.
The FDA declined to be interviewed on the topic but told Fox News in a statement, "Following the meeting, the FDA career staff will take the committee’s input into account as they continue their review of the application."
No new medications for PTSD have been approved in the last 20 years, and the treatments that are out there have limited results. PTSD patients are commonly prescribed selective serotonin reuptake inhibitors (SSRIs), which are a class of antidepressants that work by preventing the body from reabsorbing serotonin.
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"For many, despite being on an SSRI, despite being on medications, they still have lost a will to live. Feelings of helplessness, of hopelessness, of despair are what they swim in. And, for some, the SSRI can numb some of those. But, for many, it's not worked," Agrawal explained of his patients.
But he says MDMA is offering new hope.
"Certainly, I've seen people cured of the desire not to live anymore. I see people cured of loss of connection. I see people come back and find meaning in their lives again," Agrawal said.
Fox News Channel producers Alexandra Rego and Liz Freden contributed to this report.
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