The Food & Drug Administration (FDA) is on the verge of a pivotal decision that could revolutionize the treatment of post-traumatic stress disorder (PTSD). They are considering the approval of MDMA-AT, more commonly known as ecstasy or molly, for therapeutic use. The FDA is expected to announce their decision by August 11th, a date that holds immense significance for veterans who have found relief from PTSD symptoms through psychedelic medicine.
The potential impact of this decision is enormous. Psychiatrists are increasingly incorporating psychedelic medicine into their therapy sessions, believing it holds the key to unlocking deeply rooted trauma. Dr. Manish Agrawal, CEO of Sunstone Therapies, describes it as a powerful medicine unlike anything he has seen in a long time. “MDMA allows people to access parts of their trauma that are deeply seated, parts they haven’t been able to reach with traditional therapy, and it does so in a loving, supportive, and safe environment,” he says.
Sunstone is participating in an Expanded Access Program, treating a limited number of patients with MDMA-assisted therapy at their Rockville, Maryland facility. However, they were not involved in the Lykos Phase II or III clinical trials that are currently under FDA review. Dr. Agrawal emphasizes the importance of a specialized approach: “You need a purpose-built space, highly skilled, trained therapists and staff. … It’s not a magic bullet. It does not work for everyone. But I have seen people really change.”
Jonathan Lubecky, a retired Army sergeant, is a testament to the power of MDMA. He battled PTSD for years, culminating in a suicide attempt in 2006. After a lengthy struggle and multiple suicide attempts, Lubecky found the Lykos trial in Charleston during hospitalization. “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 shared with Fox News.
Now, Lubecky is hopeful the FDA will approve MDMA so other veterans can access this life-changing treatment. “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?” he asks.
Last month, Lubecky joined a group of veterans on Capitol Hill to raise awareness about MDMA treatment. They constructed a memorial out of dog tags to honor the 17 veterans who die by suicide every day, a stark reminder of the urgent need for effective PTSD treatments. The memorial also represented the 13 million Americans suffering from PTSD, including 7% of veterans.
Many veterans are already seeking out psychedelic-assisted therapy overseas, incurring personal debt to access it. The Heroic Hearts Project connects veterans with these services abroad. Founder and President Jesse Gould states, “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.”
Over 60 bipartisan lawmakers have sent a letter to the Biden administration urging 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 declared in their letter.
Among the lawmakers advocating for approval is Texas Republican Rep. Morgan Luttrell, a former Navy SEAL who was medically retired due to a traumatic brain injury. He describes his experience with psychedelics as 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,” he explains, calling the treatment equivalent to 20 years of therapy condensed into three days.
Juliana Mercer, a Marine Corps veteran and founder of Healing Breakthrough, a nonprofit working alongside Heroic Hearts Project, also shares her transformative experience. “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,” she describes.
Studies on MDMA show promising results. The Multidisciplinary Association for Psychedelic Studies found that 67% of participants no longer met the criteria for PTSD two months after completing their sessions. However, despite these positive findings, the FDA’s advisory committee voted against MDMA approval last month.
Kim Witczak, a consumer representative on the committee who voted no, expressed concerns about potential selection bias in the clinical trials and safety issues. She also highlighted the pressure campaigns targeting lawmakers. Witczak believes rushing drugs to market could lead to a dangerous process of retracting them if they are found unsafe later.
The FDA declined an interview but stated they will consider the committee’s input as they continue reviewing the application. The lack of new PTSD medications in the last 20 years and the limited effectiveness of current treatments have fueled the urgency for alternative therapies.
Dr. Agrawal describes the struggles of patients currently on selective serotonin reuptake inhibitors (SSRIs), a common class of antidepressants. “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.” He believes MDMA offers a glimmer of 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.”
The FDA’s decision will have far-reaching consequences for the lives of veterans and the future of psychedelic medicine. The potential benefits for those struggling with PTSD are undeniable, but the weight of the decision and the potential risks must be carefully considered.
