US FEDERAL GOVERNMENT
By Aug. 11 the FDA is set to make a decision on approving MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD). In recent years, MDMA, a drug with psychedelic properties known commonly as “Molly,” has been researched, combined with therapy, to treat PTSD in veterans.
In anticipation of the upcoming decision, veterans, bipartisan lawmakers and PTSD experts gathered in front of the U.S. Capitol last month to advocate for FDA approval of this treatment method, focusing in on veteran suicide rates. One of those veterans, Lynn Krug, an Austin-based former military police officer who founded Brass Ovaries, a multi-functional aerial arts studio in Austin, said she had to travel outside of the country to find an effective treatment for her PTSD.
“I want other veterans to have that same experience, but within the United States,” Krug said. “They shouldn't have to leave the U.S. just to get help.”
Legislation researching this treatment method, led by former U.S. Navy SEAL Rep. Dan Crenshaw (R-TX), was signed into law in 2022 as an amendment to the year’s National Defense Authorization Act. Originally introduced as a bill, the intention was to decrease the suicide rates in veterans and active-duty individuals. According to the VA’s 2023 National Veteran Suicide Prevention Annual Report, the veteran suicide rate is estimated to be be- tween 17 and 44 per day.
In early June, an FDA advisory committee voted against allowing MDMA- assisted treatment to treat PTSD. In the advisory meeting, members voted 9-2 that MDMA-assisted treatment is not effective for treating PTSD, and 10-1 that the benefits of this treatment do not outweigh the risks. While the committee’s opinion may be influential, it is up to the FDA to make the final decision within the coming week.
“I think the FDA wants to get this approved,” Rep. Crenshaw said. “But you know, I think that [the advisory committee is] bringing up design flaws in their studies, and… I'm not sure how valid those criticisms are.”
Retired U.S. Navy SEAL Rep. Morgan Luttrell (RTX) who co-led the research legislation and is now a prominent supporter of this bipartisan effort, was not always a supporter of this treatment method.
“I haven't been on the proverbial side of – I'll just say psychedelic treatments – I guess five years is when I kind of turned the corner, when I started seeing the research and the numbers,” Rep. Luttrell said. “I'm a research-based guy, so I really wanted to see the analytics of it all.”
The Congressman said that speaking with members of the military that had gone through the treatments and hearing their results are what changed his mind.
“I went from a hard no to an absolute [yes],” Rep. Luttrell said. “And [I’m] very passionate about it now. I understand the concerns and the worries that – not only the American public – everyone has. I got it – I do 100%. That's why I'm really, really making sure that this is research-based treatment, so it's very structured and very organized.”
There are currently only four types of antidepressant medications (called SSRIs/SNRIs) the VA recommends to treat PTSD. Only two of those medications are FDA-approved treatments for this specific purpose, according to the American Psychological Association (APA). A recent drug trial for MDMA- assisted treatment showed that 71% of participants no longer met the criteria of having PTSD. If this treatment is approved, it would be the first new treatment for PTSD in 25 years.
“This is a breakthrough therapy and it's been since the 1950s that we truly have had breakthrough therapies here in the U.S.,” said Rep. Bergman (RMI), a retired U.S. Marine Corps Lt. General and a prominent supporter of MDMA-assisted treatment for veterans.
The Veterans Health Administration is preparing to integrate MDMA-assisted therapy into their health care system pending possible FDA approval.
AnaBelle Elliott is a senior at Texas State University, majoring in journalism and minoring in music. She serves as the president of the Texas State chapter of the Society of Professional Journalists, as editor-in-chief of the Texas State chapter of Her Campus (a national online magazine) and as a Life & Arts reporter for The University Star. Elliott spent the summer interning on Capitol Hill as a journalist covering Congress.