Reagan Udall Foundation’s PTSD Meeting Was “Reassuring,” Says Healthcare Expert

Last Friday, on September 6, 2024, the Reagan Udall Foundation for the US Food and Drug Administration (FDA) hosted the public meeting, “Advancing Treatments for Post-Traumatic Stress Disorder,” for federal partners and stakeholders to share their views on the unmet need in PTSD therapies and current efforts to fill this need.

Colin Beatty, co-founder and chief executive office of Column Health, told HCPLive the meeting was “useful and reassuring.” Beatty has an expertise in both substance use disorder and psychedelic medicine.

“[It was] just reassuring confirmation of what we assumed was between the lines and behind the scenes of the recent [federal] denial for MDMA de-scheduling coming out of the Lykos MDMA clinical trial,” Beatty said. “And they acknowledged that the need is massive.”

He continued by saying how speakers provided daunting statistics, including how 6 million veterans a year need mental health care, and that is only counting those who receive it through the Veterans Affairs (VA) system. Among veterans, 14% get diagnosed with PTSD.

“The idea that these are anything other than dramatically complex mental health issues, I think is irrationally exuberant,” Beatty said. “I think they were definitely confirming that they acknowledge that what they have seen, what we have seen, what those data are that are available around the efficacy of this treatment, that it defies a simple solution.”

He finds it reassuring that the federal government recognizes the need for improvements in treatment and access to treatment, rather than coming up with pseudo-clinical models of care “out of thin air.” He explained creating new models will not be as scientifically based, which can be tricky to apply to broad populations.

He also touched upon how both the panel and public commentators mentioned the need for more data on PTSD treatments. Although the current data is meaningful, they have small sample sizes. Beatty stressed the need for more meaningful, structured data that could inform multidisciplinary care

“I particularly appreciated their nod to that acknowledgment that the work is not done yet,” Beatty said.

Currently, the VA is supporting 12 trials to evaluate potential PTSD treatments, as mentioned by a speaker at the meeting. However, Beatty believes, that because of the small sample sizes, there needs to be a lot more than 12 trials—and more focused on psilocybin.

“The fact that there's not a lot focused on psilocybin, and yet most of the legalization and decriminalization efforts at a state level are focused on psilocybin, I think there's an incongruity there,” Beatty said. “There's a disconnect around the research and trials of a macro nature at a federal level, versus what people are comfortable legalizing and decriminalizing, and that's what we see happening in the States, and that's an interesting dynamic to play out in terms of getting this out into the market before a state and conservative federal government, instead of subset agencies, is willing to accommodate a de-scheduling or a movement to more more free and easy access to these modalities of care.”

References

^{Derman, C. Reagan Udall Foundation for FDA Facilitates Discussion on Urgent Needs in PTSD Therapy. HCPLive. September 6, 2024. https://www.hcplive.com/view/reagan-udall-foundation-for-fda-facilitates-discussion-on-urgent-needs-in-ptsd-therapy. Accessed September 9, 2024.}