We are profoundly disappointed by the FDA Advisory Committee’s vote against approval of MDMA for use with therapy (MDMA-AT) to treat post-traumatic stress disorder. Unfortunately, the Committee completely lost sight of the big picture amidst a novel and complex application.
It is hard to describe how tragic and heart wrenching this vote was for so many of our Veterans, who have been on the frontlines battling for more research and compassionate use access to this treatment. Indeed, we lose 17-44 Veterans every single day to deaths of despair such as suicide or overdose – often resulting from unresolved trauma in service to this country – and the problem only seems to be getting worse. Despite rates of PTSD and suicide increasing for decades, we have seen little progress with new treatments, including no new FDA approved drugs for PTSD in over 20 years.
Considering the clear limitations of currently available medications such as SSRIs and talk therapies, MDMA-AT offers a seemingly obvious and logical approach to treating PTSD. The drug’s ability to rapidly establish therapeutic rapport and reduce fear response makes it easier to commit to and engage in a psychotherapeutic process that involves confronting often highly traumatic memories. Indeed, the incredible success stories utilizing MDMA-AT from both patients and highly qualified clinicians, particularly those with extensive careers treating the military and Veteran community, tell a compelling story of why this is so desperately needed for many long-struggling individuals.
Yet, even despite the incredibly promising efficacy results in clinical trials developed in consultation with and agreed upon by the FDA, the Committee unfortunately could not seem to grasp the research nor post-approval regulation of a drug plus therapy combination. Members of the Committee seemed confused about what they were even voting on.
We are hopeful the FDA will reach a different decision, after more work is done to finalize the risk evaluation and mitigation strategy (REMS) and elements to assure safe use, as well as to resolve ongoing investigations of data collection and reporting misconduct. These unresolved issues weighed heavily throughout the Advisory Committee’s meeting.
We believe the benefits of MDMA-AT, particularly alongside a stringent REMS (we suggested the added requirement of video monitoring and recording), clearly outweigh the risks. Indeed, the unfortunate reality is that even with FDA approval, we are many years away from this resource-intensive treatment ever reaching a significant number of people, so there is ample time for additional real-world safety data collection before any notable public health impact. Yet, there are still thousands of Veterans and other Americans whose lives may not only be saved over the coming years, but greatly improved, which will have a major ripple effect for caregivers, family, friends, and communities at-large.
Thus, we urge the FDA to work diligently but swiftly to approve this treatment. While it is unfortunately too late for those we have lost, it is not too late for so many others who have been suffering for so long, particularly within the Veteran community, who have tried everything at their disposal over the course of many years, and who deserve the opportunity to legally access this powerful novel treatment. Veterans should not be forced to continue leaving the country or seeking out underground providers for MDMA-AT or other psychedelic therapies.
Lieutenant General Martin R. Steele, US Marine Corps (Retired)
Cofounder of Reason for Hope and Founder & President of Veteran Mental Health Leadership Coalition
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