FILE - In this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off Cape Neddick in Maine on Dec. 11, 2017. The FDA has rejected the use of MDMA therapy to treat PTSD. (AP Photo/Robert F. Bukaty, File)
Robert F. Bukaty / AP
Earlier this month, the Food and Drug Administration announced it would not approve the use of MDMA, also known as ecstasy, in the treatment of Post Traumatic Stress Disorder. The agency instead asked drugmaker Lykos Therapeutics to further study the safety and efficacy of the treatment.
Taylor West, executive director of the Oregon and Colorado-based Healing Advocacy Fund, calls that decision, “deeply disappointing.”
“There is a large amount of research related to the FDA application, and more broadly in the field, that shows that psychedelic-assisted therapy has incredible promise to help us deal with mental health challenges,” West says.
Still, West is encouraged by the psychedelic-assisted therapy that is being done, including in the VA Portland Health Care system.
Taylor West is the Executive Director of the Healing Advocacy Fund. She calls the FDA's decision to reject MDMA-assisted therapy for PTSD "unconscionable."
Courtesy Healing Advocacy Fund
She says, “It’s notable that the VA has been doing this work and is saying that they will continue doing this work despite the FDA not being able to get on board with these particular clinical trials.”
West spoke with “All Things Considered” host Geoff Norcross.
This conversation has been lightly edited for clarity.
Geoff Norcross: What is your reaction to the FDA’s decision?
Taylor West: You know, it was deeply disappointing. I think there is a large amount of research, both related to the FDA application and more broadly in the field, that shows that psychedelic-assisted therapy has incredible promise to help us deal with mental health challenges that we really don’t have great therapies for at this time.
Norcross: The FDA convened a panel of experts, which it usually does when it’s conducting a review like this. And that panel overwhelmingly said that the company that conducted the trials may have shown some promise, but it had not proven that the benefits outweigh the risks. What is your understanding of what that panel was taking into account?
West: You know, this panel, as well as the FDA, are really designed to evaluate protocols that treat pharmaceuticals in a silo. And this is a really innovative type of treatment that uses the medicine in an integrated way with therapy to create the effective response. This is not something that the FDA is used to evaluating. The good news is that states like Oregon and Colorado that are paving the way for psychedelic-assisted therapy can create innovative approaches in a way that the federal bureaucracy is just not set up to do.
Norcross: Do I take it then that Oregon will have to figure out a legal framework for MDMA therapy like it did with psilocybin?
West: Right now, we’re very focused on ensuring that the current program is successful and continues to serve people in a thoughtful and safe way. And that program, in addition to the one in Colorado, are built around psilocybin-assisted therapy right now. So that will be the continued focus for the immediate term, and I think there will be opportunities for continued innovation in the future. But it is meaningful that we have these state programs to offer the promise of psychedelic-assisted healing, given that the FDA is not moving forward with the MDMA program.
Norcross: Would you push for a ballot measure here right now?
West: As I said, we are really focused on ensuring that the current program continues to operate and grow effectively. More than 5,000 people have already been through the Oregon program and we’re anticipating that to continue to grow, as well as Colorado coming online next year. So we’re going to stay focused on making those successful and then make further decisions down the line.
Norcross: Yeah, I can certainly understand focusing on the states and these experiments that are happening here. But there’s so much uncertainty around this question federally. We are going to have a new president next year, and that president could appoint an Attorney General or a new DEA leader who might have strong views about whether any state should be dabbling in what are still considered Schedule 1 drugs. Are you concerned about that political possibility?
West: It’s certainly true that that is a situation that could happen. What we know is that the precedent has been set for states to truly be these laboratories of democracy, these sites for innovation. And the precedent is that the federal government has maintained a hands-off approach to those programs, particularly when they are designed as carefully and thoughtfully as the ones in Oregon and Colorado are. It is a risk that we take, but it is a risk that is 100% worth it, given that it allows us to bring this care to people who desperately need it.
Norcross: The Department of Veterans Affairs recently launched a center in Portland that is dedicated to psychedelic-assisted therapy for veterans with PTSD, including trials using MDMA. What do you see as the potential benefit from that work?
West: It is absolutely true that the VA has been quite interested in these therapies because they, perhaps more than any other agency within the government, is aware of just how ineffective our current strategies are for managing and treating PTSD. It’s notable that the VA has been doing this work and is saying that they will continue doing this work despite the FDA not being able to get on board with these particular clinical trials.
Click on the audio player above to hear the whole conversation.
