FDA Committee 'Completely Lost Sight Of The Big Picture' Says Retired Lieutenant General Urging Approval On MDMA For PTSD

"Unfortunately, the Committee completely lost sight of the big picture," said retired Lieutenant General of the US Marine Corps, Martin R. Steele. He was commenting on this week's recommendation by a committee of advisors to the U.S. Food and Drug Administration against the approval of MDMA-assisted therapy as a treatment for PTSD.

Steele is also a co-founder of a non-profit policy and advocacy organization dedicated to advancing safe and equitable access to psychedelic therapies to improve mental health and prevent deaths of despair, Reason for Hope and founder and president of the Veteran Mental Health Leadership Coalition – a member-based organization under Reason for Hope that focuses on increasing access to psychedelic therapies for veterans.

A joint statement from Reason for Hope and Veterans Mental Health Leadership Coalition expresses profound disappointment with the FDA Advisory Committee's vote against MDMA also known as ecstasy. MDMA has been studied for over a decade as a potential treatment for mental health conditions. The therapy in question involved administering MDMA capsules to patients undergoing psychotherapy sessions with a licensed professional. The vote is, however, not binding on the FDA, and the final decision is expected in August.

No New FDA-Approved Drugs For PTSD In Over 20 Years

"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," Steele stated. "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."

Steele further highlighted the obvious limitations of currently available treatments for PTSD like SSRIs and talk therapies.

Rep. Derick Van Orden (R) recently commented that what the "Veterans Administration is doing is not working in preventing veteran suicide. We can quantify that. We have numbers, we have widows, we have widowers, we have kids without parents because they’ve committed suicide as a direct result of their service to our nation.” Orden is a sponsor of the psychedelics-focused measure, H.R.7347, which would amend the United States Code to direct the VA Secretary to report on whether to include certain psychedelic drugs in the VA formulary.

Numbers Don't Lie

According to data from Stop Soldier Suicide, veterans are at 72% higher risk of suicide than those who haven’t served, making suicide the second leading cause of death in veterans under age 45. In 2021 alone, 6,392 veterans took their own life.

"MDMA-AT offers a seemingly obvious and logical approach to treating PTSD," Steele wrote."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."

Despite all of this 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."

Reason for Hope and the Veteran Mental Health Leadership Coalition are hoping the FDA will reach a different decision after more work is done on the risk evaluation and mitigation strategy.

"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." Steele concluded.

See Also: Psychedelic Stocks Trip Up After FDA Advisors Reject MDMA For PTSD Treatment

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