MDMA will, eventually, help many with PTSD
As the executive director of the nonprofit Pearl Institute here in Waynesville, I wanted to express my gratitude to The Smoky Mountain News for the feature story written by Cory Vaillancourt about the recent decision by the FDA to request more research into using the drug MDMA in combination with therapy to treat post-traumatic stress disorder (PTSD).
It was well-researched, accurate and thoughtful and it gave the reader an excellent overview of this recent disappointing decision by the FDA to not yet approve this potentially revolutionary treatment.
However, I was disheartened and disappointed by the choice of wording on the cover which in large, bold words simply said, ‘Not Medicine’ and then below that, “FDA Rejects MDMA for PTSD.” The first statement is incorrect (based on the research) and misleading because no one at the FDA has said that MDMA, when used under clinical supervision, is “not medicine.” The FDA is acknowledging that the research is promising but they want more data before they make the final decision so they are actually delaying the decision rather than rejecting MDMA as a medicine for PTSD.
The FDA allowed formal research with MDMA to begin in the late 1990s and Phase 1 research demonstrated that MDMA was medically safe when given under supervision to healthy volunteers. The Phase 2 research that followed intended to investigate whether MDMA when used with therapy under clinical supervision could effectively treat some of the toughest cases of PTSD. A total of 107 participants with PTSD were treated and they had suffered from PTSD for an average of 18 years and had unsuccessfully tried conventional psychiatric medications and therapy. The participants were largely composed of veterans and first responders and after 3 MDMA-assisted sessions and 12 talk therapy sessions, 67% of them no longer qualified for a PTSD diagnosis. In 2017, MDMA-assisted therapy was given “Breakthrough Therapy” designation by the FDA. The resulting Phase 3 studies targeted almost 200 chronic PTSD sufferers and after the same 3 MDMA-assisted sessions and 12 talk therapy sessions, between 68% and 71% of them no longer qualified for a PTSD diagnosis. People need to stop for a minute and think about what those numbers really mean.
It means that MDMA used under clinical supervision, is, indeed, medicine. It also means that after only 3 treatments embedded within talk therapy sessions over about 18 weeks, over 2/3 of those who had been suffering for years with moderate to severe PTSD were free. They were free of the intrusive thoughts and memories, the nightmares, the flashbacks, the rages, the hopelessness and the anxiety and fear they had been living with for years with some for most of their lives. At this point, worldwide, MDMA has been tested on over 1,700 people and there has only been one serious adverse event. Not only does the research indicate that MDMA is a medicine, it also can be used safely and effectively under clinical supervision.
I have been a licensed clinical psychologist in Western North Carolina for almost 23 years. I have worked in many different settings but I spent much of my time supervising and providing mental health services to the students and families of the Haywood, Jackson and Macon public schools from 2004 until 2018. I have seen firsthand the ravages of domestic violence, childhood physical and sexual abuse, assault, substance abuse and other forms of trauma. Although current PTSD treatments can help with controlling symptoms and helping people function, they are often not effective for the deep healing that is needed. Although the Veterans Administration does what they can to help veterans coping with PTSD, there are 22 veterans in the United States every single day committing suicide, mainly due to their inability to cope with their PTSD. And the FDA has not approved a new medicine for PTSD in over 20 years.
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About 15 years ago, I realized that if I were to trace back to the beginning of the mental health struggles of 90% of the cases I have supervised and treated over the last 35 years, regardless of diagnoses, their struggles were rooted in poorly integrated traumatic experiences. People had to then compensate for the resulting biological, emotional and psychological damage of trauma and it is these compensations that are actually given diagnoses. Therefore, I reasoned, if we were able to develop a treatment that could truly heal the underlying damage of trauma, then we would make a 100-year leap in our ability to treat a wide variety of mental illnesses.
Based on the data from the last almost 30 years of FDA-approved research, MDMA-assisted therapy (when administered under clinical supervision) is both safe and more effective than any currently accepted treatment for PTSD. The FDA was intimately involved in the research design and conduct of the Phase 3 studies so it is odd and disheartening that they would now order that another Phase 3 research is required. This will cost tens of millions of dollars and take years. Meanwhile, people with PTSD will continue to suffer and die. To me, based on what we know about MDMA and MDMA-assisted therapy, it should be given conditional approval so research can proceed to Phase 4 studies where PTSD patients could be treated with MDMA-assisted therapy and we could continue to track safety and efficacy data and learn more about how to safely use this treatment responsibly and intelligently.
The Pearl Institute was one of only two sites in the United States that had permission to legally treat PTSD patients in the FDA’s Expanded Access program and I directly witnessed the healing power of MDMA-assisted therapy. We treated three patients from WNC and one from the Triangle area (including a veteran and a law enforcement officer) and all four had suffered from moderate to severe PTSD for a minimum of 35 years and had unsuccessfully tried previous psychiatric medicines and therapy. One of our patients had suffered from PTSD for 62 years and all four had pretty much given up hope of ever being free of PTSD. At the end of 3 MDMA-assisted sessions and 12 talk therapy sessions, none of them qualified for a PTSD diagnosis anymore. None of them.
There is ample evidence that MDMA-assisted therapy IS medicine. The Pearl Institute is dedicated to continuing the efforts to make this and other cutting edge mental health treatments available to people suffering in our region. It is also important to remember that PTSD does not just affect the sufferer but family members, loved ones and co-workers are also affected. Our mountain culture has been significantly affected by the effects of trauma being passed down from generation to generation and the research that has been done on MDMA-assisted therapy indicates that it has the capacity to interrupt and heal the effects of trauma and PTSD. We have a significant veteran population in our region that would benefit from safe and legal access to this treatment.
Please read beyond the headlines when it comes to MDMA-assisted therapy for PTSD. Despite this delay by FDA and some of the criticisms, most researchers agree that it will likely be approved by the FDA in the next 2-4 years and the Pearl will be well-positioned to be able to help bring this to our family members, friends and neighbors who are currently struggling to live day to day with PTSD. In the meantime, visit us at www.pearlpsychedelicinsitute.org or on social media or on our newly launched YouTube channel. Our mission is to continue to help shepherd this and other cutting-edge treatment into mainstream acceptance through education, treatment and research.
(Raymond Turpin lives in Haywood County. He can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..)
