Lawmakers Express Bipartisan Support for MDMA-Assisted Therapy to Treat PTSD
A bipartisan coalition of U.S. senators and representatives has issued letters in support of MDMA-assisted therapy (MDMA-AT) as a treatment for post-traumatic stress disorder (PTSD). With a Food and Drug Administration (FDA) decision on the approval of the therapy expected this week, the letters illustrate increasing government interest in the therapeutic use of psychedelics and their changing public profile after decades of stigma and criminalization.
In separate letters addressed to FDA Commissioner Dr. Robert M. Califf and President Joe Biden, lawmakers highlighted the alarming rates of suicide among veterans, with over 150,000 suicides since 9/11, and the inadequacy of current PTSD treatments. Both letters emphasized the FDA’s role in evaluating MDMA-AT, designated a “Breakthrough Therapy” by the FDA in 2017. House members, including Dan Crenshaw (R-TX) and Alexandria Ocasio-Cortez (D-NY), called “MDMA-AT the most effective PTSD treatment ever developed” in their letter.
A group of 19 senators, including co-sponsors Michael F. Bennet (D-CO) and Thom Tillis (R-NC), and notable signatories such as Kyrsten Sinema (I-AZ) and Rand Paul (R-KY), stressed the dire consequences of untreated PTSD, such as “homelessness, addiction, depression, and suicide.” The senators wrote, “If comprehensive evidence demonstrates that MDMA-AT is both effective and safe, it is our responsibility to ensure that this treatment option is made available to those who could benefit from it.”
Meanwhile, 61 members of the House of Representatives, led by Jack Bergman (R-MI) and J. Luis Correa (D-CA), both participants in a July 10 press conference at the Capitol Building, highlighted the extensive research supporting MDMA-AT. They pointed to Phase 3 trials showing that “71.2% of participants no longer qualified for a PTSD diagnosis” after three sessions, with 86.5% experiencing “‘clinically significant’ improvements” in symptoms.
“Despite billions of federal dollars spent on addressing PTSD and mental health, the number of Veteran lives lost to suicide has not decreased,” the representatives noted. “Promising new treatments like MDMA-AT have the clinically proven potential to bring Veterans who have long suffered with PTSD a treatment that works.”
In an interview with Lucid News, Rep. Bergman said that about a year and a half ago, he and Rep. Correa created the congressional Psychedelics Advancing Therapies (PATH) caucus to host roundtables and seminars to hear from researchers in the field and those who had participated in psychedelic-assisted therapies, largely veterans. “We have come to understand that there is the potential for life-changing therapies out there,” said Bergman. “And we, as the U.S. Congress, have to create the environment that encourages the research and therefore the outcomes that can happen right here in our own borders, [so] that people wouldn’t have to go somewhere else in the world to get the treatment that they need.”
Differences In Interpreting the Data and Its Critics
Both letters acknowledged the FDA’s statutory obligation to weigh the risks and benefits of new therapies. The House letter, addressed to President Biden, directly referred to questions raised by outside advisors about the current New Drug Application submitted by Lykos Therapeutics for MDMA-AT. The lawmakers wrote, “It is not our intent to urge the FDA in any direction related to its decision, which must be based solely on the data and evidence.” The authors of the letter also charged, however, that “certain groups and individuals have voiced criticism of the application” that “is not necessarily reflective of the science.” Representatives did not address the multiple concerns about safety, research bias, and oversight in the clinical trials raised by critics. They said opponents of MDMA-AT “may be well-intentioned” but that their criticism reflects “their personal ideological beliefs and biases related to medicalization” of psychedelics.
“While all Americans are free to voice their views on this and other topics of public interest,” said the representatives, “scientific evidence should not be ignored in favor of those who have been on a mission to discredit this promising treatment at all costs – especially when that would come at the cost of our servicemembers and Veterans.”
The Senate letter, addressed to FDA Commissioner Califf, took a more measured approach, urging the agency to “remain firmly anchored in scientific evidence and data when evaluating new treatments.” Senators wrote “the potential for groundbreaking advancements in PTSD treatment is within reach,” calling MDMA-AT “one of the most promising and available options to provide reprieve for veterans’ endless PTSD cycle.” They noted that in the seven years since the treatment was designated as a Breakthrough Therapy, developments have advanced to include “several innovative therapies currently under review and more on the horizon.”
“The FDA is internationally recognized as the gold standard for drug safety and efficacy review,” the senators wrote. “We urge the Agency to continue upholding this rigorous standard of safety, quality, and effectiveness, especially for therapies targeting conditions like PTSD, which is alarmingly prevalent among our nation’s veterans.”
According to Rep. Bergman, no matter what decision the FDA makes about MDMA-AT, Congress will continue to follow the scientific research into psychedelic therapies. He said there are targeted appropriations in House bills this year to provide research funding. The 2024 National Defense Authorization Act is a yearly bill passed by Congress to specify the annual budget and expenditures for the U.S. Department of Defense (DoD). According to Bergman, the bill includes language requiring the DoD to conduct clinical trials into psychedelic treatments for active duty service members and allocates $10M in funding for that research in fiscal year 2025.
“Representative Corey and I got two amendments passed unanimously supporting VA funded research and encouraging them to prioritize training therapists,” added Bergman. “It’s not just the drug compound, it’s the therapists who are trained to understand how this is gonna affect that interaction with the patient. We’ve been encouraging the VA to quickly make a formulary decision following any FDA approval on the MDMA-assisted therapy.”
As a retired U.S. Marine Corps lieutenant general and member of the Veterans Affairs Committee, Bergman says he has visited VA research and therapy sites in New York and California where psychedelic therapies are investigated. He said that members of Congress are taking steps to make people more aware of these proposed treatments and “support good scientists and good research[ers] that are not afraid to take a step that may not have been normal yesterday, but there is evidence that it could be normal tomorrow.”
As for the concerns raised by those who oppose FDA approval of MDMA-AT due to past abuse by a therapist involved in clinical trials and potentially biased research data, Bergman said he supports therapist training and screening plus “guardrails and guidelines so that kind of bad behavior, inappropriate behavior, cannot occur. You make good policy for the 80% positive, not the 5% negative. That’s not good policy.”
If the FDA chooses not to approve MDMA-AT, Bergman said members of Congress who support this therapy are not going to stop advocating for new mental health therapies that are supported by scientific research.
“We’re not gonna quit if the FDA says no. We’re not gonna quit because we know that it’s the right thing to move forward with new breakthrough therapies,” said Bergman.
“When you think about the U.S. as the lead researcher in new components, new therapies, all new technology, new anything, we still do lead the world in 80% to 90% of the cases. Regardless of whether we are talking about therapies for mental health or whether we are talking about technologies for advancing manufacturing, we are the leader in the world,” said Bergman. “Those of us who believe this are going to find a different way to ensure that we can bring the Washington bureaucracy, in this case the FDA, forward in a safe manner.”
Courting Psychedelic Voters
Several signatories of the House and Senate letters supporting MDMA-AT also represent states where psychedelic decriminalization, legalization, or access initiatives, as well as cannabis legalization, have either been passed or are on the ballot for the 2024 election. As grassroots movements towards state acceptance of psychedelics and psychedelic-assisted therapies have gained momentum, lawmakers in Washington D.C. are watching and responding to these shifts in public opinion.
Senator Bennet, an organizer of the Senate letter, represents Colorado, which has decriminalized some psychedelics. The state is at the forefront of developing post-prohibition drug policies and practices. This month, Colorado released rules for licensing and training of facilitators for the state’s first psychedelic therapy program, a step toward implementation of Proposition 122 and the Natural Medicine Health Act. This year, the City and County of Denver and the MAPS nonprofit rolled out a first-of-its-kind comprehensive training for psychedelic crisis assessment and intervention for first responders. Colorado has also legalized medical and recreational cannabis. Colorado representatives who signed the House letter include Doug Lamborn (R-CO) Joe Neguse (D-CO), Brittany Pettersen (D-CO), and Jason Crow (D-CO).
California has also been on the forefront of the current psychedelic reform movement, and a number of cities including Oakland, San Francisco, Berkeley, Arcata, and Santa Cruz have already decriminalized some psychedelics. Several statewide initiatives to change access to psychedelics have to date been unsuccessful, including California Senate Bill 1012, The Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-Assisted Therapy Act, which died after consideration by the Senate Appropriations Committee. Advocates for legal access to psychedelics in California say they are planning a ballot measure to bring the issue before voters. California has also legalized medical and recreational cannabis.
Lawmakers from California who signed the letters include Jimmy Panetta (D-CA), David G. Valadao (R-CA), Jim Costa (D-CA), Tom McClintock (R-CA), Michelle Steel (R-CA), Kevin Kiley (R-CA), Tony Cárdenas (D-CA), Julia Brownley (D-CA), Robert Garcia (D-CA), Salud Carbajal (D-CA), Eric Swalwell (D-CA), Young Kim (R-CA), and Doug LaMalfa (R-CA).
With the passage of Measure 109, Oregon has legalized psilocybin therapy with regulated access, and also legalized medical and recreational cannabis. Last April, the state reversed a 2020 voter-approved measure, Measure 110, which decriminalized all drugs in Oregon. The reversal reflected a rollout of the Measure “that was hobbled by implementation issues,” according to the Associated Press. Restored penalties for possession of small quantities of drugs, including psychedelics, will go into effect on September 1. Senators Ron Wyden (D-OR), Jeffrey A. Merkley (D-OR) and Rep. Val Hoyle (D-OR) signed onto these letters.
Eight Massachusetts cities have deprioritized arrests around psychedelic plants and fungi, including Salem, Somerville, Cambridge, Northampton, Easthampton, Amherst, Provincetown, and Medford. Signatures are currently being gathered to place House Bill 4255 on the ballot. The bill would decriminalize limited personal use and create regulated access to “natural psychedelic substances,” including psilocybin, DMT, ibogaine, and mescaline, excluding peyote, for adults 21 and over. Senator Edward Markey (D-MA) signed onto the Senate letter to the FDA.
Michigan, a fiercely contested swing state in the presidential race, has decriminalized access to some psychedelics in five jurisdictions, including Ann Arbor, Detroit, Ferndale, Washtenaw County, and Hazel Park. Sen. Gary C. Peters (D-MI), and Reps. Jack Bergman (R-MI), Bill Huizenga (R-MI), John James (R-MI), Elissa Slotkin (D-MI) signed onto this week’s letters.
The Washington city of Seattle decriminalized noncommercial activity around some psychedelics in 2021. Responsible Entheogen Access and Community Healing Coalition (REACH) Washington, an advocacy organization, aims to place Initiative Measure No. 2076, the Natural Psychedelics and Supportive Services Act on the ballot for the 2025 legislative session. Rep. Marilyn Strickland (D-WA) signed onto the House letter to the FDA.
New York has legalized medical and recreational cannabis, and has introduced Assembly Bill A10375, which proposes the legalization of psilocybin. Signatories from the state include, Alexandria Ocasio-Cortez (D-NY), Patrick Ryan (D-NY), Yvette D. Clarke (D-NY), Claudia Tenney (R-NY), and Adriano Espaillat (D-NY).
While not mentioned in the letters, Washington, D.C. has decriminalized some psychedelics, which could influence representatives from nearby areas. Signatories from states neighboring the District include Reps. David J. Trone (D-MD), Abigail Davis Spanberger (D-VA), Robert J. Wittman (R-VA), and Sen. Tim Kaine (D-VA).