August 09, 2024 (NEW YORK) – Reason for Hope and its member organization, the Veteran Mental Health Leadership Coalition, issued a joint statement in response to the Food and Drug Administration's recent decision to deny approval of MDMA-assisted therapy in treating post-traumatic stress disorder (PTSD).
Lieutenant General Martin R. Steele, US Marine Corps (Retired), Cofounder of Reason for Hope and Founder & President of the Veteran Mental Health Leadership Coalition, shared his thoughts:
We are incredibly disappointed with the FDA’s plainly incorrect decision. There is an urgent need and clear demand from the Veteran community for new PTSD treatments, and MDMA-AT has demonstrated safety and profound efficacy in clinical trials based on protocols negotiated and agreed upon with the FDA as part of a Special Protocol Assessment.
It is hard to see how the FDA’s decision can be justified when it has plenty of tools to ensure a slow, cautious roll-out of this novel treatment, which could have at least been conditionally approved with required safety data collection and post-marketing studies, as well as a more restrictive risk mitigation strategy. Instead, Veterans will continue to be forced to leave the country or to seek underground providers for MDMA-AT or other psychedelic therapies, which is a tragic and unconscionable outcome.
While we remain confident MDMA-AT will eventually be approved, there is no doubt that this decision will lead to more unnecessary suffering and lives lost. However, Reason for Hope and the Veteran Mental Health Leadership Coalition, whose members and partner organizations have tirelessly advocated to make their voices heard, will continue doing whatever it takes to help get this across the finish line.
About Reason for Hope
Reason for Hope works tirelessly to broaden access to life-saving breakthrough therapies and treatments for patients – particularly our nations’ Veterans – by bringing together the most knowledgeable team of doctors, scientists, legal professionals, policy advocates and changemakers to advocate for sensible policies and collaborate across sectors. The interest and support from regulatory bodies like the FDA and the growing body of research suggest a shifting paradigm in mental healthcare, one that explores alternative treatments and embraces a more holistic approach to addressing mental health disorders. Reason for Hope is working to change outdated overregulation by honoring those who served and supporting their need for emerging mental health treatments. For more information, visit https://www.reason-for-hope.org/.
The Veteran Mental Health Leadership Coalition
The Veteran Mental Health Leadership Coalition is a national membership based Veteran organization focused on education and advocacy to increase safe and affordable access to psychedelic therapies for Veterans and their families. For more information, visit: https://vmhlc.org/.
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