In June, an advisory committee to the Food and Drug Administration voted that the agency should not approve MDMA therapy for post-traumatic stress disorder. It was a resounding blow to patients and advocates, including the veteran community. The FDA isn’t required to follow committee recommendations, but it almost always does. The agency is expected to issue its decision August 11.
Many of the Psychopharmacologic Drugs Advisory Committee’s reservations implicate larger isssues with MDMA therapy. But it was also specific shortfalls of the research presented by Lykos Therapeutics that caused members to vote 9-2 against MDMA’s efficacy in helping treat PTSD, and 10-1 against its safety.
Video testimony from members of the public, coupled with a critical Institute for Clinical and Economic Review (ICER) draft report that had been released in March, highlighted concerns about an environment where patients were vulnerable to sexual assault. Among those who testified was a proxy for a trial participant who was inappropriately touched during an MDMA session by her two facilitators, a husband and wife team, and who has also alleged sexual assault by another facilitator who was not a licensed therapist.
“Nurturing touch that occurs when the participant is deeply re-connecting with times in life when they needed and did not get it can provide an important corrective experience,” states the Lykos therapist training manual. “Another kind of touch that can be therapeutic is focused bodywork, usually in the form of giving resistance for the participant to push against.”
To learn more about the complex issues around safety, consent and accessibility, Filter spoke with Dr. Genesee Herzberg, co-founder of Sage Integrative Health, who was one of the licensed therapists involved in the Phase III Lykos trials. Herzberg and eight others who worked on the trials co-authored a response to the ICER draft, acknowledging certain critiques and pushing back on a number of others; another 64 signatories added their names in support. Our interview has been edited for length and clarity.
“When it comes to work with MDMA, touch becomes more important. MDMA can lead to regression to preverbal or young self states, and … often words don’t get through.”
Alexander Lekhtman: What was your first reaction to the FDA advisory committee’s vote?
Dr. Genesee Herzberg: I was disappointed. I have witnessed and been in touch with many people who suffer from PTSD, and I have witnessed the very impactful and efficient change MDMA can bring in psychotherapy. I was concerned this will prolong the time it takes for people to gain access to a modality that can help. There are so few PTSD treatments out there that are effective, those that exist are often too intense for people.
There certainly are risks to the treatment and it’s important we talk about those—the issue of sexual boundary violations that came up was really upsetting. It’s something we need to do our best to make sure does not happen again.
AL: Can you explain the appropriate role of “nurturing touch” and “focused bodywork” in MDMA therapy?
GH: I am trained in Relational Somatic Healing, which is a form of therapeutic touch integrated into psychotherapy, generally without medicine. I think with a therapist well-trained in offering touch, and working with consent, it can be an incredibly supportive approach to deepening the therapy, to helping people drop into preverbal states … that are very hard to access otherwise.
When it comes to work with MDMA, touch becomes more important. MDMA can lead to regression to preverbal or young self states, and all the vulnerability and emotion that comes with them. From those states, often words don’t get through. Physical presence and touch are what’s most helpful in supporting the individual so they feel held and cared for and able to process their trauma. It’s vital the therapist be well trained in holding people in these sensitive states and obtaining informed and ongoing consent. We have seen major breaches to that.
Generally it’s encouraged that you only offer touch at the level you’re experienced in. Nurturing touch is the most simple—just involved holding someone’s hand, or a hand on the shoulder or forehead. Like what a friend might offer.
“Sometimes people say they are not interested in therapeutic touch during the prep session, but then during the MDMA session they ask for it. We will hold the boundary we agreed upon.”
AL: How do you reconcile MDMA’s effects with someone’s ability to give consent?
GH: We have a long discussion around touch and consent in the preparation phase. Getting a history about their relationship to touch, any trauma related to it, and their cultural conditioning. If they’re not open to touch, we just leave it there.
Sometimes people say they are not interested in therapeutic touch during the prep session, but then during the MDMA session they ask for it. We will hold the boundary we agreed upon prior to the MDMA session—if you say “No” before, and ask for it during, we will offer an alternative like placing your own hand on your heart or holding a pillow or pushing against a wall. Then we can circle back after that session … to determine if you do want to incorporate touch in the future.
AL: Does it pose a risk to patients if, as a cost-saving measure, only one of the two facilitators overseeing their treatment has to be a licensed therapist? For example, the facilitator accused of sexually assaulting a patient was not licensed. The provincial board basically told the patient that they couldn’t do anything because the facilitator didn’t have a license to take away.
GH: There are many routes to accessibility. The most important is insurance coverage, [but another is] hiring and training pre-licensed therapists. Not “unlicensed” folks, but people who are on the track to licensure but haven’t yet completed all their hours and taken the exam. Pre-licensed people expect to get paid less, so it would certainly lower the cost. I do think there’s an ethical issue with the tendency to underpay masters- and doctoral-level therapists who are not yet licensed, related to a societal undervaluing of mental health in general.
If less-experienced therapists are in the room with a licensed therapist, I think that is an incredible way to ensure safety and that the pre-licensed person is holding the work in a good way. Live supervision is one of the best forms of training, getting to witness someone doing the work and get direct feedback. Co-therapist teams should be debriefing after each session … It’s a great way for both therapists to learn.
If someone wanted to file a complaint, they have the same ability to go to the board and if the person acted in a problematic way to have their license, or their potential to be licensed, revoked.
When it comes to people not on licensure tracks at all, I feel torn about this. It’s a complex question—there are many people who, say, were trained in Indigenous traditions, and have been doing this work for decades. To say those people aren’t eligible because they don’t have a license would take away from the potential diversity and depth of experience and knowledge they hold. On the other hand, not having that route of accountability is concerning. That’s why we need better systems of accountability within the field so when something comes up it’s not just a [psychology] board people can go to, but a governing body that regulates psychedelic therapists specifically.
“There’s a giant hype around psychedelics and this idea that if you have one or two experiences you will be cured.”
AL: Opponents of MDMA therapy argue that it will cost a lot of money up front. But it actually reduces health care expenses in the long-run. Are those competing interests?
GH: There is a good chance people with complex PTSD will need more sessions, more MDMA and integration sessions in order to recover. [But] it also appears that MDMA speeds up the therapeutic process—maybe we’re looking at two years of psychotherapy and six MDMA sessions, as opposed to 10 or 20 years of psychotherapy. It’s still likely to [save costs], reducing emergency room visits, intense suicidality, heart disease, all kinds of problems that add to the overall cost of untreated trauma.
The larger issue I think is relevant is what’s been happening in the media the last five years. Michael Pollan’s book [How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression and Transcendence] really brought forward what I call “the myth of the magic pill.” There’s a giant hype around psychedelics and this idea that if you have one or two experiences you will be cured.
That’s the experience of [a few] people. But in general, and for people with complex PTSD, it’s not like that. It’s an intensive process. It requires openness to looking at and working with your trauma, and re-experiencing feelings that are very intense, going back to memories that were dissociated. One of the issues I’ve noticed is that for some people, three MDMA sessions isn’t enough.
There’s all the hype in the media … that I think led some people to feel disappointed when it didn’t work as well for them. Or like they had failed somehow.
Some people who spoke up felt like they were dropped after the study. Unfortunately, that was the nature of the study—it needed to end, so we could collect and analyze the data. It really should be a longer-term treatment for some.
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