Post-traumatic stress disorder is a scary reality facing 13 million Americans, acutely affecting veterans who risked their lives to serve our country and resilient survivors of sexual assault and domestic abuse. Helping these individuals find relief where they can is imperative, and one federal agency is considering action that could do just that.
The U.S. Food and Drug Administration is set to vote on the approval of MDMA-assisted therapy (MDMA-AT) to treat PTSD in the next few days. Unlike the only two drugs currently on the market to treat this illness that do nothing to actually address the root cause of the disease, MDMA-AT actually has the potential to help patients overcome the root cause of their diagnosis, and it's backed by science.
Every day we wait for MDMA-AT to get approved, another veteran's life is put at risk. Our nation's veterans are experiencing a suicide epidemic with an estimated up to 16,000 veterans currently dying from suicide each year, coming out to a staggering 44 veterans per day. Our veterans cannot wait another day.
During a phase three clinical trial of this innovative drug, 71 percent of participants no longer qualified for a PTSD diagnosis, and 86 percent experienced clinically significant reductions in their symptoms. These results surpass the efficacy of the only two drugs currently on the market to treat PTSD.
Seven Veterans Affairs clinics across the country are currently practicing MDMA-AT, with the VA even requesting federally funded studies to test the therapy to treat veteran PTSD.
The FDA has already shown wide support for the drug, including designating it as a "Breakthrough Therapy" in 2017 for its efficacy and granting it "expanded access status" in 2020 so individuals experiencing severe, life-threatening forms of PTSD could be given this treatment by their mental health professional without having to participate in a trial.
Despite the science and the support from the FDA and VA pointing to every reason as to why MDMA-AT should get approval, the FDA's Advisory Committee (AdComm) voted to not recommend approval of MDMA-AT. If the FDA chooses to follow the AdComm's recommendation, ignoring data and their own previous support, it will be the millions of PTSD patients who will have to suffer longer before they can get the treatment they need.
During my work in the Montana legislature and with veterans groups across our state, I have been at the forefront of advocating to advance treatments that could help treat PTSD, and with more than 78,000 veterans living just in our state, I have seen firsthand the dire need for more therapies that could get to the root cause of the illness. Action by the FDA to approve MDMA-AT would provide sweeping advancements in this regard.
Science exists to bring great innovations to the forefront to help those who are suffering, which is why it is imperative that the FDA approve this new medical treatment.
Looking beyond Montana, we have strong leadership in Congress, such as Senator Jon Tester who sits as the Chairman of the Senate Committee on Veterans Affairs, who we hope will take the lead on encouraging the FDA to follow the science by voting in favor of MDMA-AT approval.
We would also encourage the Biden Administration to urge the FDA to approve MDMA-AT.
Montanans, like me, will continue to do our part to push for innovative new treatments like MDMA-AT to help patients suffering from PTSD. It is my hope that our partners at the federal level will do the same.
Roger A. Hagan is a former member of the Montana House of Representatives and retired member of the United States Air Force and Air National Guard.
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