A bipartisan coalition of 19 U.S. Senators and 61 Members of the House of Representatives have sent letters to the Food and Drug Administration (FDA) and President Biden, urging swift and scientifically-based approval of MDMA-Assisted Therapy (MDMA-AT) for treating post-traumatic stress disorder (PTSD).
MDMA, often referred to as “ecstasy”.
Led by Sens. Michael Bennet (D-Colo.), Thom Tillis (R-N.C.), Kyrsten Sinema (I-Ariz.), and Rand Paul (R-Ky.), alongside Reps. Jack Bergman (R-Mich.), Lou Correa (D-Calif.), Morgan Luttrell (R-Texas), and Jimmy Panetta (D-Calif.), the letters highlight the urgent need for new PTSD treatments, especially for veterans. This initiative is backed by 15 additional senators and 57 more members of the House, reflecting widespread bipartisan support.
“MDMA-AT has shown incredible promise, with 71% of phase-three trial participants no longer meeting a PTSD diagnosis after three eight-hour sessions of MDMA-AT”, states a press release from Rep. Bergman. “Moreover, 86.5% of participants experienced “clinically significant” improvements in their PTSD symptoms. These results are more than double that of the current best treatment for PTSD.”
The House letter was sent to President Biden and administration officials, highlighting the need for new PTSD treatments and the promise of MDMA-AT to prevent suicide among veterans. The letter also urges the FDA to follow scientific evidence when making its approval decision on MDMA-AT, which is expected within the next week.
“Unfortunately, the FDA approval process has been hindered by outside groups that have been on a mission to discredit this promising treatment at all costs”, says the press release. “While hearing from the public is an important part of the process to approve a new drug, biased anecdotes should not be valued over the data from scientific trials – especially when rejection would come at the cost of the lives of our servicemembers and Veterans.”
The letter states, in part: “Thousands of Veterans suffering from PTSD continue to take their lives each year. Current treatments clearly are not working well enough, and our Veterans can no longer wait. If the data and evidence show that MDMA-AT is safe and effective at relieving the suffering that many Veterans face, then we owe it to them and the millions of others who are living with PTSD to make this treatment option available to them.”
The Senate letter, addressed to FDA Commissioner Robert Califf, emphasizes the necessity of adhering to scientific evidence in evaluating MDMA-AT. The senators note that current PTSD treatments, the latest of which was approved nearly 25 years ago, have failed to reduce the suicide rate among veterans. They underscore the dire consequences of untreated PTSD, including heightened risks of homelessness, addiction, and depression, which contribute to the alarming rate of 6,000 veteran suicides annually.
“Existing treatments and medicines for PTSD… 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,” the senators wrote.
They urge the FDA to maintain its rigorous, evidence-based review process, stating, “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.”
You can find the full letter sent by senators by clicking here. For the letter sent by members of the House, click here.
