Bowling Green Today

U.S. Senators Rand Paul (R-KY), Michael Bennet (D-CO), Thom Tillis (R-NC), Kyrsten Sinema (I-AZ), and 15 of their Senate colleagues have urged U.S. Food and Drug Administration (FDA) Commissioner Robert Califf to rely on scientific evidence and data as the FDA considers approving MDMA-Assisted Therapy (MDMA-AT) for treating Post-Traumatic Stress Disorder (PTSD). They argue that MDMA-AT could address the mental health crisis, particularly among American veterans.

“Existing treatments and medicines for PTSD, the last of which FDA approved nearly 25 years ago, have not decreased the frequency of suicide within the veteran community. As a nation, we cannot allow our veterans to continue to suffer in silence and must identify treatments proven to drastically decrease the adverse effects of PTSD,” wrote Paul, Bennet, Tillis, and Sinema.

Annually, 6,000 U.S. veterans die by suicide. Untreated mental health challenges such as PTSD increase risks of homelessness, addiction, and depression among veterans. Breakthrough therapies like MDMA-AT offer new hope for those suffering from PTSD; however, further research is necessary to ensure these treatments are safe and effective.

“The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence,” continued the senators. “The rigorous, evidence-based review process by the FDA will be critical in making informed decisions that could offer a new lease on life for many individuals, including veterans.”

Joining Paul, Bennet, Tillis, and Sinema were U.S. Senators Cory Booker (D-NJ), Catherine Cortez Masto (D-NV), Tammy Duckworth (D-IL), John Fetterman (D-PA), Martin Heinrich (D-NM), John Hickenlooper (D-CO), Tim Kaine (D-VA), Ben Ray Luján (D-NM), Ed Markey (D-MA), Jeffrey Merkley (D-OR), Markwayne Mullin (R-OK), Gary Peters (D-MI), Peter Welch (D-VT), Sheldon Whitehouse (D-RI), and Ron Wyden (D-OR).

The letter emphasized that untreated PTSD can lead to severe consequences such as homelessness, addiction, depression, and suicide. It noted that since 9/11 over 150,000 veterans have died by suicide. The senators stressed that innovative therapies like MDMA-AT offer significant promise in breaking this cycle.

Seven years after designating MDMA-AT as a Breakthrough Therapy in 2017, several innovative therapies are under review or on the horizon. The senators insist that FDA's evaluation should remain grounded in scientific evidence.

Given the substantial burden of PTSD and current treatment limitations, new therapies' potential effectiveness is particularly significant. If comprehensive evidence shows MDMA-AT is both effective and safe when administered appropriately, it should be made available to those who could benefit from it.

“We appreciate your consideration on this critical issue,” concluded the letter.

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