In what could be a pivotal moment for the future of medical psychedelics, the Food and Drug Administration (FDA) is considering whether to approve MDMA-AT, also known as ecstasy or Molly, as a treatment for post-traumatic stress disorder.
The FDA is expected to make a decision by August 11th.
The decision will have a major impact on veterans who say hallucinogens have helped ease their PTSD symptoms, and psychiatrists have been incorporating them into therapy sessions.
“We haven’t seen a drug this powerful in a long time,” Dr. Manish Agrawal, CEO of Sunstone Therapies, told Fox News.
As FDA considers approving MDMA, Marine veteran touts benefits of psychedelic drug for PTSD treatment
The VA will study both MDMA, also known as ecstasy and magic mushrooms, and psilocybin-assisted therapy. (iStock)
“MDMA allows people to access deep-seated parts of trauma that traditional treatments cannot access in a safe, loving and supportive environment,” Agrawal says.
Sunstone participates in an expanded access program that allows it to treat a limited number of patients with MDMA-assisted therapy at its facility in Rockville, Md. Sunstone is not participating in Lycos’ Phase 2 or Phase 3 clinical trials being evaluated by the FDA.
“We need dedicated spaces. We need highly skilled and trained therapists and staff. … If MDMA cured PTSD, then everyone who went to raves would be de-traumatized,” Agrawal said.
“It’s not a magic bullet. It doesn’t work for everybody. But I’ve seen people really change.”
Jonathan Lubecky is a military veteran who was treated with MDMA. Lubecky had a long battle with PTSD. He attempted suicide on Christmas morning in 2006, 60 days after returning home from Iraq. After eight years of battling and several suicide attempts, Lubecky found a Lycos trial in Charleston while hospitalized.
“The first time I took MDMA was three times as part of a clinical trial. I haven’t taken it since. I haven’t developed PTSD since then so I don’t feel the need to take it,” Lubecky told Fox News.
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Jonathan Lubezki, a former Army sergeant who volunteered as a medic in Ukraine, found the Lycos trial in Charleston while hospitalized after an eight-year battle with illness and several suicide attempts. (Courtesy of Jonathan Lubecky)
Now Lubecki hopes the FDA will approve the use of MDMA, allowing veterans like him to get the treatment they need.
“I remain hopeful because the FDA will approve it, if not on Aug. 11 then someday. The only question for them is how many veterans, how many American lives will be lost by then,” Lubecky said.
Last month, Lubecky joined a chorus of veterans on Capitol Hill to raise awareness about MDMA treatment.
Veterans built piles of identification tags and memorials to commemorate the 17 veterans who die by suicide every day and the 13 million Americans, including 7 percent of veterans, who suffer from PTSD.
Veterans and lawmakers gathered at the Capitol to dedicate a dog tag memorial to the 17 veterans who take their own lives each day. (Fox News Channel)
Veterans seeking help often travel outside the U.S. to receive psychedelic treatment and incur personal debt. Jesse Gould, founder and president of the Heroic Hearts Project, which connects veterans with their service overseas, said he understands the irony.
“The FDA alone holds the key to allowing veterans access to MDMA-assisted therapy, and approval of this treatment is not just a formality; it is literally a lifeline to our nation’s veterans,” Gould said.
More than 60 bipartisan lawmakers sent a letter to the Biden administration urging approval of MDMA.
“Thousands of veterans suffering from PTSD continue to commit suicide each year. Current treatments are clearly ineffective, and veterans cannot wait any longer,” the lawmakers warned in the letter.
Among those backing the approval is Rep. Morgan Luttrell, R-Texas, who served 14 years as a Navy SEAL before being medically retired due to a traumatic brain injury.
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“The word psychedelics scares people. It scared me,” Luttrell told Fox News, describing his personal relationship with psychedelics as “nothing short of an exorcism.”
“This treatment allows us to address what’s lurking, breathing, and suppressing in the deep cognitive regions of the brain, and that’s usually what people need,” Luttrell said, describing the treatment as the equivalent of 20 years of therapy in three days.
Rep. Morgan Luttrell, R-Texas, served 14 years as a Navy SEAL before medically retiring due to a traumatic brain injury. (Courtesy of Rep. Morgan Luttrell)
Juliana Mercer, a Marine Corps veteran and founder of Healing Breakthrough, a nonprofit that works with the Heroic Hearts Project, said after undergoing treatment she felt a weight lifted off her shoulders.
“I woke up the next day filled with joy, a new sense of love for myself and others in my heart, a whole new way of thinking and for the first time in a really long time I felt connected to my true self,” Mercer said.
According to the Interdisciplinary Association for the Study of Multidisciplinary Psychedelics, an MDMA study found that 67% of participants no longer met criteria for PTSD two months after completing their sessions.
Despite these positive reviews, an FDA advisory committee voted down MDMA last month. Kim Witczak, a consumer representative who served on the committee and voted against it, spoke to Fox News about the decision:
“Clinical participants, researchers and former Lycos employees have come forward to say there may have been issues with selection bias,” Witczak said.
Witczak cited safety concerns and public pressure campaigns targeting lawmakers, explaining that rushing a drug to market can lead to a long and dangerous process of withdrawal if it is later found to have safety issues.
Despite high hopes from veterans, FDA panel rejects MDMA for PTSD treatment
MDMA pills (Fox News Channel)
“My message to the FDA is that whenever there is suspicion, they must investigate. … Once the genie is out of the lamp, it’s too late to try to put it back in,” Wittczak said.
The FDA declined to be interviewed for this story, but told Fox News in a statement that “Following the meeting, FDA staff will continue their review of the application, taking into account the committee’s comments.”
No new medications have been approved for the treatment of PTSD in the past 20 years, and current treatments have limited effectiveness. People with PTSD are often prescribed selective serotonin reuptake inhibitors (SSRIs), a type of antidepressant that works by blocking the reabsorption of serotonin in the body.
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“Despite being on SSRIs and taking medication, many patients lose the will to live. They feel helpless, hopeless and hopeless. For some, SSRIs are able to numb some of those feelings, but for many, they don’t work,” Agrawal said of his patients.
But MDMA offers new hope, he says.
“I’ve certainly seen people healed of their desire not to live, I’ve seen people healed of losing connection, and I’ve seen people come back and find meaning in life again,” Agrawal said.
Fox News Channel producers Alexandra Rego and Liz Freden contributed to this report.
