/2024/06/17/1718634577853.gif?w=3840)
Illustration: Natalie Peeples/Axios
Lawmakers are redoubling efforts to secure psychedelic treatments for veterans after an FDA advisory committee overwhelmingly recommended against what would be the first such drug approval in the U.S.
Why it matters: Some veterans and others living with post-traumatic stress disorder say MDMA along with psychotherapy has reduced their symptoms and given new hope for those with a condition that has few treatments.
- An estimated 13 million Americans suffer from PTSD.
Driving the news: Members are using the annual defense authorization bill and the appropriations process to advance the cause, noting that FDA advisers faulted the sponsoring company's trial design but found hallucinogenics could have some medical benefit.
- "It's not the end of the world," Rep. Dan Crenshaw told Axios. "We're forcing the DoD to do more trials. ... That's what you need. More data, more trials. And we'll get there."
- Lawmakers are focusing now on the VA, which early this year announced it would solicit applications to study the use of psychedelic compounds in treating PTSD.
- "The VA is already doing pilot studies on this in their research and innovation, so we continue to ask them to consider this treatment" Rep. Mariannette Miller-Meeks told Axios. "So far it looks to be safe and it doesn't have the addictive potential as other medications."
- Among the most prominent voices is Rep. Morgan Luttrell, a former Navy Seal who's been outspoken about how psychedelic therapies helped him cope with a traumatic brain injury from a helicopter crash.
- "For the United States to make progress in this field, we must continue to fund research to expand our understanding of the mechanisms behind psychedelic-assisted therapy and its long-term effects," he wrote in a blog post last week.
State of play: There have been several amendments addressing MDMA therapy in play recently, including on appropriations bills as well as the NDAA which passed the House on Friday.
- Last year, the NDAA included a measure that for the first time, allowed the Department of Defense to fund a clinical study on the effect of psychedelic substances such as MDMA for service members who have experienced PTSD or a traumatic brain injury.
- Rep. Nancy Mace submitted a bipartisan amendment to this year's NDAA which would have enabled the Drug Enforcement Administration to change substances such as MDMA from Schedule I to Schedule II, making it easier to conduct research.
- The House Appropriations MilCon-VA bill that the House passed this month also contained two amendments on psychedelics that were adopted with little debate.
- One expressed congressional support for VA-funded research into psychedelic-assisted therapies and encouraged the VA to start proactively training therapists in the event the FDA approves an MDMA treatment.
- The other amendment ordered a report to Congress on psychedelic treatments being added to the department's formulary.
Flashback: 9 out of 11 FDA advisers earlier this month voted against Lykos Therapeutics' application to use ecstasy with psychotherapy for PTSD, citing concerns about missing safety data, allegations of misconduct in clinical trials and questions about whether supervised counseling, rather than the drug, was responsible for the reported benefits.
- The FDA is expected to make a final decision on the application by Aug. 11.
The intrigue: Crenshaw cited the difficulty of doing trials on such substances, because the drugs' notable effects would make it instantly recognizable to patients who got them versus a placebo and could raise their expectations of benefitting from the treatment.
- "I think FDA needs to recognize that it's very hard to design a trial with a placebo with psychedelics, you can't do that," he said.
