The Breakthrough Therapies Act will save veterans’ lives
As we prepare to honor all those who served in the U.S. military on Veterans Day, we can do so by taking action and remembering that the mental health crisis facing our veterans remains an ongoing battle.
Our veterans often bear the invisible wounds of war. The mental toll of military service, particularly in combat zones, is well-documented. Despite the heroic nature of their service, veterans can grapple with a myriad of issues, including post-traumatic stress disorder (PTSD), depression, anxiety, substance misuse, treatment-resistant depression and suicidal thoughts and behaviors. Currently available treatments like selective serotonin reuptake inhibitors (SSRIs) have been insufficient in addressing PTSD, and many are left with significant, ongoing symptoms as they struggle to carry on with their lives after service. In fact, it is estimated that up to 40 veterans are lost to suicide every single day. That figure alone should tell you everything you need to know about the current state of the veteran mental health crisis.
In the midst of this unprecedented crisis, data coming out of our nation’s best and brightest research institutions are showing that psychedelic compounds — when administered in clinical settings and under the care of licensed medical professionals — could provide potentially lifesaving relief to those suffering from a myriad of mental health and addiction disorders. The research has been so encouraging that the FDA has designated MDMA- and psilocybin-assisted therapies as “breakthrough therapies,” meaning that they demonstrate substantial improvement over any currently available treatments, have an acceptable safety profile and low-abuse potential.
Despite their tremendous promise, MDMA and psilocybin are still prohibitively difficult to access and research given their Schedule I status under the Controlled Substance Act (CSA). Bureaucratic red tape is slowing down the advancement of research and the availability of potentially lifesaving treatments for veterans, and all those suffering with life-threatening conditions. We must ask ourselves: shouldn’t we make it easier for doctors and researchers to do their job and save lives?
Unfortunately, veterans suffering with suicidal ideation aren’t in a position to wait around. In acts of bravery and desperation, we know that thousands of veterans are seeking psychedelic-assisted therapy (PAT) in the underground here in the U.S., risking serious criminal penalties. Self funded or through sponsoring non-profits, many more are traveling to Central and South America, to countries where it is legal for them to receive PAT. This is the state of affairs of veteran mental health in America: our war fighters are being forced to risk criminal penalties or leave the country they fought to protect in order to get the help they need. Something needs to change.
That something is the Controlled Substance Act. Earlier this year, U.S. Sens. Cory Booker (D-N.J.) and Rand Paul (R-Ky.) introduced the Breakthrough Therapies Act. The bipartisan legislation would bring down the regulatory hurdles inhibiting research and the compassionate use of potentially lifesaving treatments that are currently heavily restricted by Schedule I of the Controlled Substances Act (CSA). U.S. Reps. Nancy Mace (R-S.C.) and Madeleine Dean (D-Pa.) also introduced companion legislation in the House of Representatives.
The Breakthrough Therapies Act would remove these blockades, expediting the transfer of substances that receive “breakthrough therapy” designation from Schedule I to Schedule II, which — with DEA oversight — will enable Veterans to access these treatments and reduce the burden on further clinical investigation. In an era of rapid scientific and medical innovation, the Breakthrough Therapies Act is a beacon of hope that promises to accelerate the development and accessibility of groundbreaking treatments for our veterans and patients in dire need.
This bill also places an emphasis on collaboration between the FDA, DEA, pharmaceutical companies and research institutions, representing a bold step toward streamlining the drug development process and fostering innovation across sectors. By bringing these stakeholders together, the act promotes transparency, the sharing of valuable information and the opportunity to pool resources to tackle the most challenging diseases. This is the kind of collaborative approach that will open up important, new frontiers in medicine and an acknowledgment of the need for a paradigm shift in the way we approach treatments for life-threatening diseases.
In the quest to support the well-being of our veterans, we must remain open to unconventional approaches. It’s time that Congress and the Department of Veterans Affairs acknowledge the potential of these breakthrough therapies to provide much-needed relief and support for those who have sacrificed so much. The current status quo of denying access to therapies and forcing veterans to seek treatments that hold such promise outside of U.S. borders is an injustice to the men and women who have served our country.
If our elected officials in Washington desire to stand in support of America’s veterans this weekend, I implore them to offer their support to the Breakthrough Therapies Act. Effective PTSD treatment is within reach, but is being slowed down by outdated overregulation. Let us honor those who served by supporting their need for alternative mental health treatments and passing the Breakthrough Therapies Act.
Lieutenant General Martin R. Steele is a retired three-star United States Marine Corps General and co-founder and CEO of Reason for Hope and member of the Veteran Mental Health Leadership Coalition — organizations dedicated to policy and grassroots patient advocacy aimed at providing safe access to psychedelic therapies to combat the PTSD, suicide and opioid crisis. General Steele also serves on the National Security Advisory Council of the U.S. Global Leadership Coalition and was nominated by Sen. Mitch McConnell to serve on the Veteran Affairs Commission on Care during the Obama administration.
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