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Lawmakers and Veterans Affairs officials on Tuesday touted the potential for psychedelic drugs to treat mental health conditions and prevent veteran suicide, but they said additional research and FDA-approval is needed before the therapies could be available.
In one of the first hearings in Congress on psychedelics since 1966, when Dr. Timothy Leary testified on the therapeutic potential for LSD, a House Veterans Affairs panel drilled VA physicians and advocates on psychiatric treatments that use MDMA, known recreationally as molly or ecstasy, and psilocybin, or magic mushrooms.
Researchers for the Multidisciplinary Association for Psychedelic Studies, or MAPS, have studied the safety and effectiveness of MDMA-assisted psychotherapy for post-traumatic stress disorder since 2004. The protocol calls for patients taking MDMA in the presence of a therapist, who then leads them through counseling. The treatment involves three eight-hour sessions.
In September, scientists published results of a recent clinical trial of MDMA-assisted therapy that showed 87% of patients had significant improvement in PTSD symptoms four months after treatment, and by the study's end, 71% no longer met the diagnostic criteria for post-traumatic stress disorder.
The treatment, designated a "breakthrough therapy" by the Food and Drug Administration in 2017, allowing for additional research, has caught the attention of congressional Democrats and Republicans.
In July, the House voted to encourage the VA to explore using federal funds for MDMA research.
On Tuesday, supporters again said they welcomed the science in an effort to reduce the number of veteran suicides. In 2020, 6,278 veterans died at their own hands, according to the VA, a rate of roughly 17 a day.
But they also expressed concern, given that the drugs remain illegal under federal law and can be dangerous if purchased and used recreationally.
"As a physician who practices traditional medicine, I never thought I would enter Congress and be then advocating for emerging breakthrough therapies, but I think science is leading the way," said Rep. Mariannette Miller-Meeks, R-Iowa, the House subcommittee chairwoman. "I want to reiterate that we are not advocating for the legalization or casual use of psychedelics, but rather the advancement of science of their medicinal properties in a clinical setting with assisted therapy."
The research into psychedelic treatments is limited, but it has shown promise, added Rep. Julia Brownley of California, the subcommittee's ranking Democrat.
"However ... it is our duty as members of Congress to ensure that treatments offered to veterans are both effective and safe," Brownley said.
Dr. Carolyn Clancy, the VA's assistant under secretary for health for discovery, education and affiliate networks, told subcommittee members that VA researchers are exploring emerging treatments and the VA's medical arm, the Veterans Health Administration, sponsored a state-of-the-art conference on psychedelic research in September to "provide a better understanding of the current state of scientific evidence" on the treatments.
She added, however, that safety remains a top priority at the VA, where research and treatments must take place in a safe environment, with quality medications and well-trained staff.
"Our focus isn't just on finding the best innovative treatment but on doing it safely," Clancy said. "The conference determined a need for clinical trials that enroll a unique and diverse population of veterans; rigorous studies of VA patients are important, because they often have mental and physical health challenges."
According to Clancy, the VA is planning to fund several of its own studies on psychedelic research, which remains a challenge given the restrictions and approval needed by the FDA and the Drug Enforcement Administration.
"But," Clancy added, "I know a number of our colleagues are excited about the possibility -- not that they think this is the answer, but they are inspired by hearing from veterans whose own experience has been very, very positive and want to be part of learning whether that is a generalizable finding for many veterans."
Two veterans who testified at the hearing said MDMA-assisted therapy was a lifesaver for them.
Jonathan Lubecky, an Army National Guard and Marine veteran who now advocates for MDMA-assisted treatment, said that before he enrolled in a study through the Multidisciplinary Association for Psychedelic Studies, he would hide in his closet on July 4 during fireworks, wearing body armor and suffering flashbacks.
On a recent trip to Ukraine, however, when air raid sirens sounded, he was able to "assess the situation, make sure my building wasn't damaged" and roll over and go back to sleep.
"The triggers still exist. There are still people dropping bombs in this world. They just don't affect me the way they did," Lubecky told the panel.
Juliana Mercer, also a former Marine, said she traveled overseas to receive MDMA-assisted therapy because it wasn't available in the U.S.
"I'm here today asking that you lead as Congress must in such moments of crisis, and continue to urge the VA to implement a nationwide program for this breakthrough therapy as soon as possible. Every day wasted means more lives lost," Mercer said.
The treatment is not without risks. In the Phase 3 trial published in September, nearly all participants experienced what is called a "treatment-emergent adverse event" -- a new symptom or exacerbated existing condition.
None were severe, but symptoms ranged from heart palpitations, high blood pressure, insomnia, anxiety and suicidal ideation. The study noted that 80% of participants had suicidal ideation when they enrolled. Fewer than a handful of participants experienced flashbacks, grief or disassociation, meaning they felt disconnected from themselves and their thoughts and feelings.
Given a potential for addiction and the growing problem of marijuana abuse in the U.S., some lawmakers have raised concerns that promoting the treatments might be tantamount to acceptance of illicit substances and could ultimately cause more harm than good.
Lubecky called a comparison between marijuana and MDMA therapy "inappropriate."
"I'll be honest, I used cannabis for five years to abate suicidal ideation, and it was highly effective. And when I moved to South Carolina and could no longer do that, everything came back. I did MDMA-assisted therapy nine years ago, and I haven't taken any mental health medication since," Lubecky said.
Given its success with the research, MAPS plans to seek FDA approval for its therapy as early as next year.
Clancy said FDA approval could take some time, given that it would not only be approving a controlled substance as a medicine, it would be approving the entire protocol, including the therapy.
"FDA approval will almost certainly be accompanied by something called a REMS approach -- a risk evaluation and management strategy -- which may be straightforward or it may be quite complicated. That will be something that we would obviously review very, very carefully," Clancy said.
She encouraged veterans who are interested in the treatment to speak with their physicians about potential inclusion in future studies and added that anyone thinking about using MDMA recreationally consult a VA provider.
Currently, VA policy prohibits doctors from recommending medical marijuana to veterans or writing prescriptions for it, even in states where it is legal. The policy is controversial, given that some veterans who have admitted to marijuana use with their physicians have had prescription medications curtailed, while others believe that VA doctors should be able to prescribe cannabis.
Clancy said there are no restrictions on veterans speaking with their doctors about psychedelics.
"We'd hope they'd have a conversation ... so that we can help ensure that they have all the information they need," Clancy said.
-- Patricia Kime can be reached at Patricia.Kime@Military.com.