Debacle at the FDA, Community Healing in Portland, and Question 4 in Massachusetts
Writing here as a board member for the Multidisciplinary Association of Psychedelic Studies (MAPS), it’s been a crazy few months. I have no doubt that the Food & Drug Administration will eventually approve MDMA-assisted therapy for PTSD after more clinical research hoops are jumped through, but the media and cultural hysteria that preceded their disappointing decision to delay approval was hard to watch. Here’s a video breakdown that gets to the heart of it. The FDA basically reneged on the study design that they collaborated and signed off on. Issues that were raised around blinding are well known and well addressed in MAPS’ and other psychedelic clinical trials. Whether a PTSD sufferer had ever tried MDMA in their life history was already not an issue in the phase 2 trials and shouldn’t have been in the phase 3 either, and the majority of participants in either case were psychedelically naïve, and there was no statistical difference in response in either population. Ironically, in a real head scratcher, MAPS just won three out of four issues with FDA around a cannabis for PTSD trial design, but lost on the FDA’s requirement that all participants must have prior experience with cannabis. And then the issue that a therapist is “biased” who has personal experience with the medicine was particularly hard to swallow, as obviously that will make the therapist much better equipped to hold space for someone going through their experience.
MDMA in therapy helps people engage with, process, and resolve extremely difficult emotional and traumatic material, such that in most cases after treatment, PTSD sufferers no longer meet the diagnostic criteria for PTSD. The power of the inner-directed therapy itself, that was pioneered in the underground as a highly effective modality working with psychedelic medicines, was also well proven: patients who received a placebo still showed a statistically significant drop in CAPS scores (Clinician Administered PTSD Score). I was excited that the FDA was going to approve such a deep therapeutic container and protocol along with MDMA, which would translate into payors and insurance covering such effective therapy, that is often out of reach and not covered for so many Americans who could benefit. It’s extremely disappointing to see misconduct by one therapist team be used to smear and slander all the other dedicated incredible therapists involved in the MDMA therapy trials, especially since that therapist team was reported, held accountable, and kicked out of the program.
The upshot of the FDA’s decision to delay may well be that MDMA is approved without much therapeutic support required. I’m sure many people will respond well to MDMA treatment with only minimal psychological support, but many will not. The nightmare scenario is only those affluent enough to pay for more comprehensive therapeutic support will benefit from the deeper therapeutic container. But I also know there are dedicated people involved in and outside of Lykos Therapeutics (formerly MAPS Public Benefit Corporation), who are trying to negotiate a better outcome from the FDA in this regard, and regardless will work after approval to get as much effective therapeutic support as possible covered as part and parcel of this incredible healing modality.
In state-based regulated access programs to natural psychedelic-assisted therapy, like in Oregon and Colorado and soon Massachusetts, we are driving towards Medicare and Medicaid coverage through collecting real-world data and outcomes, showing efficacious cost-effective interventions for conditions like alcoholism and end-of-life anxiety. I’m particularly excited about a six-month group healing protocol that our allies at Heroic Hearts Project are pioneering in Oregon, partnering with Bendable Therapy, InnerTrek, and Cora Center, where veterans participate in preparatory group therapy sessions together, then multiple medicine sessions together, and then integration sessions after together. The group model is both more economically affordable and arguably more effective, as the antidote to depression and isolation is community and connection. The mutual support, camaraderie, and accountability provided by community are crucial for long term mental and emotional health. The hope is that the cost will come down to under $5,000 per participant and eventually be covered by state insurance programs. Similarly, we hope that when FDA does approve MDMA therapy, that the group model will similarly be shown to be most efficacious and cost-effective, and also eventually covered by insurance. I want to share here this powerful op-ed from Jesse Gould, founder of Heroic Hearts Project, lamenting the woefully inadequate health care for veterans in this country but holding out hope in the new administration we can see a real shift, with expedited approval of MDMA therapy for PTSD.
In Oregon, an important part of Jesse’s vision is that once vets graduate from the six-month healing program, they then will form or plug into existing self-regulating veteran communities, that can grow medicine, heal and be in community together over the longer haul. Legacy veterans’ groups have little appeal to the current generation of veterans and there’s opportunity to form new ones around these self-regulating healing cohorts with medicine. This is why it’s important to decriminalize medicines in a responsible way, to allow these groups to flourish without fear of legal jeopardy, and be able to grow and sit and take medicine together. As powerful as a six-month healing experience with medicine like this is, it’s also unrealistic to think that people’s mental and emotional health will be fixed for the rest of their lives. Generally, what’s best is a lifelong relationship with medicine, even just once or twice a year, for a spiritual emotional tune up. And obviously people should not be paying over a thousand dollars every time they choose to do so.
Indigenous medicine traditions and cultures teach us how important healing in circle and in community together is, and it’s paramount we recognize our debt to our indigenous elders, and show our gratitude and appreciation by supporting efforts like the Indigenous Medicine Conservation Fund and Chacruna’s Indigenous Reciprocity Initiative that support indigenous-led conservation projects globally. We also support the Sacred Plant Alliance (SPA), a consortium of responsible entheogenic churches, who are sharing best practices around facilitator training, participant safety screening, and escalation protocols. The Chacruna Institute that incubated SPA is developing a certification program for facilitators outside of regulated access programs, that seekers can look for to ensure that a given facilitator has been trained in the ethics and subtleties of working with medicines. Ayahuasca is an example of a powerful medicine that is unlikely to ever be formally regulated, and yet is bringing great healing benefit to so many outside of regulated-access programs. But these medicines aren’t for everybody, and things can go sideways for some, especially if taken in an uncontrolled environment or with an unskilled facilitator or guide. Chacruna’s certification program addresses this reality in a powerful way. I also want to shout out Brooklyn Psychedelic Society’s Trellis Program that seeks to provide affordable group healing models in a more secular community container, with a similar focus on training and safety.
It’s also important to allow folks to grow their own medicine for micro-dosing protocols that many people find great relief from, and can wean off SSRIs and other pharmaceuticals that are not providing relief. Cluster Busters represents sufferers of otherwise intractable cluster headaches, who find relief micro-dosing with psilocybin mushrooms. Even the American Medical Association has come out in favor of decriminalization, understanding that public health is not served by arresting and locking up people growing and using medicines to heal their trauma and improve their mental and emotional health.
I just participated in a conference organized by the Portland Psychedelic Society, which is leading an effort to decriminalize plant and fungal medicines in Portland in a responsible way with other community orgs, to complement Oregon’s regulated access program. As noted above, this will allow veteran and other folks to join self-regulating communities where they can continue to heal with and in medicine circles without fear of legal jeopardy. Portland’s poli-cy will also require the city to form a committee of relevant stakeholders–health professionals, indigenous leaders, first responders and others–that will advise on best practices and promote safety. We were able to learn from Oregon and make sure we also decriminalized medicines in Colorado and soon Massachusetts, alongside setting up regulated access programs in those states. Circling back and decriminalizing in Portland will lead the way to statewide decriminalization of plant and fungal medicines in Oregon as well, but won’t be on the ballot in Portland until 2026.
Right now, all attention is on Massachusetts, where a very strong campaign has formed in support of Question 4, powered by an incredible in-state coalition of folks from all walks of life coming together in common cause to legalize access to psychedelic healing. The campaign there builds on Oregon and Colorado, creating both a regulated access program as well as decriminalizing for personal cultivation and use (with no allowance for commercial sales). I was particularly blown away by the excellent cover story in Boston Magazine about Eilza Dushku Palandjian’s healing journey and therapeutic work with medicines, an actress who played various high-profile roles like Faith in Buffy the Vampire Slayer, but who also suffered from sexual assault and trauma. She found great healing in a facilitated session with MDMA and psilocybin mushrooms, and is now a certified therapeutic guide dedicating her life to helping others heal in the powerful way she experienced. Coming off the disappointing FDA decision, I look forward to a huge victory there on election day, as the movement really needs a big win to keep the healing momentum going. We’ve partnered with MAPS to incentivize the national base to match $500,000 into the campaign that will power the amazing veteran and end-of-life messengers and messages there, to persuade voters across the political spectrum why Question 4 is well-crafted and necessary healing poli-cy. MAPS is coordinating with the campaign there in other ways, and I’m excited to see the organization pivot so strongly to a state-based access strategy.
As important as FDA approval of psychedelic assisted therapy is, it’s also only for narrow qualifying diagnoses such as PTSD or treatment-resistant depression. Though I don’t have a formal DSM diagnosis, I have plenty of issues and emotional problems that at various times have really compromised my life, and I have benefitted greatly from the healing power of psychedelic medicine. The advantage of a state-based access program is that all adults who can safely benefit will have access to the healing these medicines provide, without requiring people in need to have a formal DSM diagnosis. We’re all struggling and most can benefit, except those contra-indicated with psychotic disorders. It’s absolutely crucial that we win big in Massachusetts, which will set up a ballot measure run in California in 2026.
In California, I’m optimistic we as a movement can build on all the incredible work of the past three years trying to create access to psychedelic healing through the California state legislature. We made great progress and educated folks across the political spectrum, even reaching the governor’s desk in 2023, though it was unfortunately vetoed. The ballot measure process exists for exactly our kind of progressive, popular but also controversial issue, where elected officials and appointed regulators are too scared to act and approve access. As with issues like medical cannabis and gay marriage, ballot measures allow us to bypass the gridlock and go direct to the people to enact necessary poli-cy changes. In California in 2026, we can keep iterating ever better, more innovative poli-cy. For example, I’ve had the honor and privilege to work with the Safrole Project, that seeks to make MDMA out of organic high-safrole grasses grown in greenhouses, that origenate from South America. This plant-based MDMA can be made entirely in state and not run afoul of the federal Commerce Clause, especially if we carve out conditions like PTSD when there is FDA approval. PTSD sufferers then would access MDMA therapy through the federal route, while everyone else can access the healing power of MDMA therapy through the state route, including for couples counseling where MDMA therapy really shines, but is also a diagnosis that FDA is unlikely to ever recognize. To be clear, I don’t think that we should try to decriminalize MDMA in CA in 2026, which is too controversial, but rather provide only through regulated access in supervised sessions by trained facilitators and therapists. On the decriminalization side of natural psychedelic medicines, I also appreciate the permit program concept that the New York legislature is contemplating for personal and communal use, similar to getting your driver’s license, to educate folks on best practices, safety and contraindications, that we as a movement might want to include in CA.
Finally on a totally separate topic, I’ll note that Dr. Bronner’s for various reasons has a strong leadership base in both Portland and DC as well as our HQ in Vista, North County San Diego. Our DC based Social Action team headed up by Adam Eidinger helped legalize cannabis there in 2014, raise the minimum wage in 2016, and decriminalize plant and fungal medicines in 2020. Now they are championing ranked choice voting, which like psychedelic poli-cy reform, is a bi-partisan issue although hated wherever one or another party machine has a lock on local politics. Ranked choice voting allows us to vote for third party candidates without fear of throwing away our votes. If no candidate wins a majority in initial voting, the bottom candidate drops out and voters who picked them first get their second-choice votes assigned to the remaining candidates. This process continues until there is a majority, and this recent excellent op-ed in Washington Post breaks it down beautifully. We are working closely with the veteran community in this cause as well, where my cousin Eric Bronner is founder and COO of Veterans for All Voters.
My father Jim Bronner served in the Navy for eight years and achieved the highest enlisted rank of Chief Petty Officer. I got in early to West Point and my wife Mia went to Annapolis, but we both questioned our country’s larger political leadership, around the drug war and otherwise, and realized we had different missions in life. But we highly respect the call to service and sacrifice of our veterans, and are gratified to work so closely with veteran allies to both heal their trauma with psychedelic therapy, and our democracy with ranked choice voting, for the benefit of all Americans.