What’s Next for Psychedelic-Assisted Therapy? Charting MDMA’s Path Forward
In the past two months, two different advisory groups – Institute for Clinical and Economic Review (ICER) and the Pharmacologic Drugs Advisory Committee (AdComm), one of several advisory groups that makes recommendations to the United States Food and Drug Administration (FDA) – independently advised against approving MDMA for medical use. The opinions dealt blows to what many had anticipated would be a relatively quick approval process for midomafetamine (MDMA) to treat PTSD, as well as a DEA rescheduling of the drug, after nearly 20 years of patient trials.
ICER assesses treatments based on pricing and access through “comparative clinical effectiveness,” aiming to bring discussions of drug pricing and patient access to the public and enabling patients to share their input. Critics point out the premature timing of some of ICER’s reports, conflicts of interest with ICER’s funding (which comes from individuals, private foundations, drug makers, and government grants), and have noted the methodology ICER uses is questionable because of the “subjective” and “arbitrary” threshold value it uses to measure a year of good health.
The AdComm is one of several independent advisory groups the FDA uses to obtain “independent expert advice on science, technical, and policy matters.” While each group only has a portion of available study data that the FDA has, their recommendations can affect outcomes as drugs move forward as treatment options, but the FDA does not always follow their recommendation.
The high profile recommendations of ICER and the AdComm put MDMA and MDMA-assisted psychotherapy (MDMA-AT) under a harsh spotlight, casting doubt on the potential of psychedelic medicine and throwing the community into turmoil.
The high profile recommendations of ICER and the AdComm put MDMA and MDMA-assisted psychotherapy (MDMA-AT) under a harsh spotlight, casting doubt on the potential of psychedelic medicine and throwing the community into turmoil. On July 7, following the ICER Report and the AdComm meeting, 27 expert researchers and clinicians signed a Consensus Statement strongly supporting MDMA-AT – a striking contrast from the previous “no” votes. They highlighted the urgent need for a more effective therapy for PTSD, the substantial evidence of efficacy in the Phase 3 trials, and the overall established safety of MDMA-AT.
The guidance came several weeks before the FDA is scheduled to make their decision. As the August 11th deadline for the FDA’s decision nears, people are working to gain clarity on the promise and the challenges MDMA–and MDMA-AT–face.
History and Study Design
After years of clinical trials, the Multidisciplinary Association for Psychedelic Studies’ drug development arm, Lykos Therapeutics (formerly MAPS Public Benefit Corp.), filed an application in December of 2023 for permission to market prescription MDMA in conjunction with psychotherapy.
The clinical trials conducted by Lykos relied on a standardized therapy model. MAPS published the first version of its treatment manual detailing this model in 2016 for the Phase 2 clinical trials. This manual was part of a larger study design that includes three MDMA sessions, as well as multiple non-drug sessions guided by a team of co-therapists, or dyad, usually one male and one female. MAPS also created an MDMA Therapy Training Program using this therapy protocol as its foundation. Since then, several other organizations and universities have created their own trainings, often in conjunction with or drawing from this model.
All therapy sessions during the trials were held at supervised clinical sites, and were recorded and randomly screened to ensure adherence to the study protocol and the therapy model. Feedback was shared with therapists after screenings in the event of deviations.
The ICER Report and AdComm Meeting
After a nine-hour meeting that included almost two hours of public comments, 11 members of the Pharmacologic Drugs Advisory Committee (AdComm) voted 9-2 that available data did not show that MDMA is effective in subjects with posttraumatic stress disorder, and 10-1 that the benefits of MDMA (with FDA’s proposed risk evaluation and mitigation strategy, or REMS) do not outweigh its risks for the treatment of patients with PTSD.
The committee’s main concerns were efficacy and safety, specifically related to functional unblinding, expectational bias, potential for abuse, and ethical issues. The ICER Report laid out many similar points a few weeks before, including “concerns about whether there were design choices that affected the interpretation of the results, but also whether there was misconduct that could have influenced the validity of the trial outcomes or that raised questions about the safety of MDMA-AT if it were implemented broadly outside of clinical trials.” While this article does not have the space to address all of the concerns, other sources have done so thoroughly.
ICER and AdComm both shared concern about possible and documented ethical violations using the MAPS therapy model. In Phase 2, a high-profile series of boundary violations of a trial participant, Meaghan Buisson, followed by continued sexual abuse after the trial’s end, resulted in the dismissal of the associated co-therapists, Donna Dreyer and Richard Yensen, from the trials in 2018. MAPS forbids sexual relationships between therapists and patients.
In the spring of 2019, MAPS published an MDMA-Assisted Therapy Code of Ethics, which “outlines ethical principles governing treatment decisions made by providers of MDMA-assisted psychotherapy within a MAPS protocol.” After a compliance review in 2021, MAPS found that the two therapists “substantially deviated” from the treatment manual and protocol on multiple occasions.
Although the impropriety involved site therapists and not corporate Lykos, several critics have raised the question of whether the Lykos therapy model, which allows supportive touch, increases risks of boundary violations.
During the hearing’s open public comment period, which was extended after a citizen petition, 31 commenters spoke out in favor of the treatment, and 10 shared sobering points against approving MDMA and, in particular, its associated psychotherapy. Many researchers and therapists say that the pros to approving MDMA-AT, now or in the near future, far outweigh the critiques.
The prevailing conclusion from both ICER and AdComm, however, was that “significant confounders” indicate the treatment needs to be “better studied,” according to AdComm committee member Dr. Maryann Amirshahi.
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Evangelism, Adherence, and the “Undisclosed Protocol”
Critics of the studies have argued that psychedelic therapists, in particular those affiliated with the Lykos trials, are overoptimistic, evangelical proponents of MDMA-assisted psychotherapy. As early as 2022, researchers and doctors David Yaden and Roland Griffiths called for a need to prepare for “the bursting of the psychedelic hype bubble.” Media and activists have increasingly scrutinized MAPS founder Rick Doblin for problematic comments about psychedelics bringing about “world peace,” “spiritualized humanity,” and “net-zero trauma.”
One of the voices that has risen to the forefront in this conversation is Dr. Neşe Devenot, a Senior Lecturer in the Writing Program at Johns Hopkins University and a board member of nonprofit media organization Psymposia. Devenot was also a co-author of the citizen petition for the public comment portion of the AdComm meeting along with Dr. Brian Pace, a lecturer in the Department of Plant Pathology at The Ohio State University who is also affiliated with Psymposia. Together, they helped organize critics of MDMA-AT and the clinical trials for the AdComm meeting. The group has received notable criticisms for their bias and anti-MAPS/Lykos stance.
Devenot’s Substack article, “MAPS is an MDMA Therapy Cult,” argues that Lykos “exploited the suggestibility-enhancing properties of MDMA to advance an evangelical mission to spiritualize humanity through the vehicle of its clinical trials,” what Devenot calls MAPS’ “undisclosed protocol.” That protocol, they note, was what “the official protocol was built for, to launder into the superstructure of federal regulatory systems.”
“The official protocol submitted to the FDA was a euphemism,” they say. “It was not admitting to the full scope of what their therapy model entailed.” That undisclosed protocol, they argue, also gave agency to therapists “to discern what the client wants even when they’re saying no” and “ultimately put agency onto the therapist to make distinctions about what is coming from an authentic place of the ‘inner healer’ or is a tactic or part preventing growth and healing.”
Cognitive bias, they say, can create a feedback loop that keeps therapists from realizing they may be expecting to see something from a patient based on their own beliefs, training, and sense of themselves – complicating the assumption that the healing is truly coming from within.
Dr. Michael Mithoefer, who authored the protocol with his wife, Dr. Annie Mithoefer and others, and is an independent consultant for Lykos, says that “inner healing intelligence” is a person-centered approach that can be traced to the earliest psychotherapy. This self-directed approach, he says, “is about not missing the new unexpected experiences.” The model, which is biopsychosocial, he explains, prepares therapists to be non-directive.
“Our specific approach, which we’ve proven is good and have a lot of data for, is certainly not the only and may not even be the best,” he says, noting it may also be used in conjunction with other therapy modalities, including cognitive-behavioral therapy. “It’s not about trying to impose this method on everyone using psychedelics, but about making sure people have a grounding in the particularly valuable quality of these medicines to allow for something unexpected.”
He does note that a potential downside is that if something comes up that a therapist is not comfortable with or doesn’t want to deal with, “they can consciously – or unconsciously – decide that this is the time the inner healer and medicine can take care of whatever is happening, when the opposite might be more valuable.”
Mithoefer adds that “saying it’s non-directive does not mean there’s never direction. It’s just all in service to what is trying to emerge already.”
Criticizing the model as “anything goes” is not accurate, note Drs. Chantelle Thomas and Ingmar Gorman (cofounder of Fluence) on an episode of Thomas’s Blind Spots podcast. Both Thomas and Gorman were therapists in the Lykos trials.
The non-directive approach is “an adaptive model” that works particularly well for situations where the level of vulnerability is enhanced, says Thomas in the podcast episode “Therapy Unblinded: Inside MDMA Research Part 2.” “Things could get icky pretty fast if you start telling people what to do while they are more vulnerable and susceptible to influence.” She admits that learning and relearning the “art of being very aware of where we were agendaed or steering even in the subtlest of ways was – I’ll be completely transparent – was a learning curve for me that became really clear when I rewatched 50 hours of video from my first participants.”
To control for this, checks in place included the videotaping of all sessions and their review by blinded adherence raters, as well as a set of criteria that had to be met across preparation, dosing, and integration sessions.
“In psychology we have this term ‘operationalization,’” explains Gorman in the episode. That means, he explains, “to take a concept or idea – or in this case a therapy technique – and define it and break it down in such a way that when a therapist does the technique or an observer sees it there can be consensus that that thing is done.”
He gives the example of “creating a sense of safety and support for the participant.” “People may have all sorts of ideas about what ‘safety and support’ means,” he says, “so you define that term and have paragraphs of description. There might even be examples, or a vignette, or mock back-and-forth between the participant and the therapist. When we operationalize the therapy we refer to that as creating adherence criteria in psychotherapy research – the purpose is precisely to address this issue of therapists doing ‘whatever they want’ in terms of the therapy.”
In previous interviews, Mithoefer has noted that adherence in Phase 2 “was imperfect.” In a March 2022 Cover Story podcast episode, “Political Science,” Mithoefer shares that “We were doing a best practices type of supervision, but it wasn’t as robust as we have now. And obviously it was not as robust as we needed it to be.”
“If MAPS was not doing robust adherence, it makes it hard to know if the psychotherapy was actually ‘identical’ between placebo and MDMA groups,” say journalists Lily Kay Ross and David Nickles.
According to the treatment manual, “It is not expected that therapists will have complete or even near-complete adherence scores. Attempting to achieve very high adherence for its own sake may interfere with the effectiveness of the therapy by distracting therapists or stifling their intuition and creativity. However, it is expected that therapy teams will achieve at least moderately high adherence ratings to ensure that therapy across different sites is consistent with the essentials of the approach described” in the manual.
The protocol in the manual asks adherence raters to evaluate adherence for “a sense of flow or allowance,” whether there is “a rhythmic feeling to the overall session that is led by the participant, with therapists supplying space for things to come up,” the allowance “for silence” and holding off on interventions, inquiry on the therapist’s part as to whether participant “is ready for their anxiety to be explored, without assuming they know where it comes from,” and the trust on the part of the therapist that “any fear, memories, etc. that keep coming up are doing so to be healed [and] more fully understood, and that the participant’s psyche/inner healer knows when the best time is for this to occur.”
“The idea that inner healing intelligence can serve as the foundation for psychedelic-assisted therapy is compelling,” says Jamie Beachy, an MDMA-assisted therapy training consultant and a field scholar with the Emory Center for Psychedelics and Spirituality. “It’s an appropriate foundation for a patient-directed approach to care that takes into account a diversity of spiritual and religious existential commitments and values.” Beachy notes there is an opportunity for more clarity around how the model works, but shares that she experienced it as “a really beautiful foundation” for the practice of MDMA-AT.
“The majority of participants really benefited from the therapy and reported positive outcomes … Some no longer met the criteria for PTSD they came into the study with. Although it’s true there is hype in the field – and there perhaps has been a ‘hype bubble’ as some have pointed out, for me that doesn’t account for the degree of recovery from PTSD I observed in research and in my experience with participants.”
Jamie Beachy
“The majority of participants really benefited from the therapy and reported positive outcomes,” she says. “Some no longer met the criteria for PTSD they came into the study with. Although it’s true there is hype in the field – and there perhaps has been a ‘hype bubble’ as some have pointed out, for me that doesn’t account for the degree of recovery from PTSD I observed in research and in my experience with participants.”
While researchers and therapists were open to learning from the “unfolding experience of patients and clients, the idea that we were sort of evangelistic in our approach to the therapy in a way that overworked the data makes no sense to me personally,” she says. “We are really rigorous, research-oriented practitioners, Ph.D.-level folks and serious clinicians. We are very open to learning from anything, whether positive, negative, or ambiguous, that would have come up in the study.”
Unpacking the “Therapy Cult”
In their analysis, Devenot compares MAPS to groups including NXIVM and the Church of Scientology, and argues that the concept of “inner healing intelligence” central to the therapy protocol is spiritual in its origins. They argue that MAPS’ inner circle used methods including manipulation, love bombing, and hypnosis to further their agendas while claiming to support the liberation of suffering, and that the protocol was designed and deployed to do this at a much larger scale. “Ultimately,” they say, “cult indoctrination is a significant iatrogenic risk for a therapy model that introduces totalizing ideologies into a context of pharmacologically induced and heightened suggestibility.”
Devenot’s decision to term MAPS a “cult” is “deeply disturbing” to Dr. Massimo Introvigne, an Italian sociologist of religion and the cofounder and managing director for the Center for Studies of New Religion.
“Scholars of new religious movements don’t use the word ‘cult,’” he explains, noting that the word was largely abandoned in the past century because “it became ambiguous.”
“Originally,” he says, “‘cult ‘was not a bad word. It just designated a young religion, so a group where most of the members had converted as adults as opposed to being born into. It was not a derogatory use of the word.”
Around the time of World War II, criminologists began to use the word to indicate religious movements whose members committed major crimes or were likely to. “That created ambiguity,” Introvigne says. The term “new religious movement” gained popularity as “cult” “increasingly became a four-letter word and a slur.” Introvigne and others use “criminal religious movement” to describe groups systematically committing crimes. These, he notes, are found among traditional religious groups, as well as new religions.
When the shift away from the word “cult” happened, a small, schismatic group of scholars “abandoned the field and constituted cultic studies,” he explains. “They are a small minority, operating largely outside of the main journals and academic societies.”
The word is also confusing “because it is based on pseudoscientific concepts,” he says. “Coercive persuasion, brainwashing, mind control…these are all synonyms.” Brainwashing is not statistically provable, he says, and is not an admissible defense in court in many countries, including the United States. He points to Margaret Thaler Singer, quoted in Devenot’s article, as a discredited academic on the topic, noting that her testimony was dismissed in United States v. Fishman, a 1990 case in which she testified for the defendant who claimed he was brainwashed by the Church of Scientology. After the dismissal, Singer was no longer allowed to testify in the United States. Her testimony in several later European cases was also dismissed.
“Of course, a very small group of cultic studies scholars still believe in Singer’s theories,” says Introvigne, “but they are tiny and not recognized as part of the mainstream. Very few, if any scholars, will regard these theories.”
Introvigne also takes issue with the mentions of NXIVM and Scientology in Devenot’s analysis. “It is malicious to compare a group which was hardly religious and recognized as criminal with Scientology,” he says. “To put them in the same sentence is highly symbolic. It indicates that all groups stigmatized as cults are like NXIVM, so they have committed very serious crimes and deserve to go to jail. It’s probably true that NXIVM’s leaders committed very serious crimes, but the leaders of Scientology are not in jail. Quite the contrary. The strategy of lumping everyone together and creating guilt by association is a well-known rhetorical figure with no valid scientific weight.”
Introvigne also calls “the notion of a therapy cult” problematic. “That too was created more than 50 years ago to attack Scientology,” he explains, “but it’s very vague. Therapy is, by definition, an attempt to influence people and change their behavior.” He shares the example of someone addicted to drugs who goes to a therapist. “The job of the therapist is precisely to change behavior,” he says.
“The idea becomes very circular,” he continues, “because we say strongly influencing and trying to change behavior is a cult, so we know this therapy is a cult because it tries to change the behavior of the patient. In this sense, we can say all therapy methods are cults by the definition of those who use this word. The use of the expression ‘therapeutic cult’ is even more problematic than the use of the word ‘cult’ for religious groups.”
Even if calling MAPS a “cult” is going too far, bias on the part of enthusiastic researchers is critical to monitor. “The researchers’ enthusiasm for psychedelic psychotherapy, which many consider to be capable of revolutionizing psychiatry, could also be a source of bias. Their beliefs and sense of mission could have favorably influenced the volunteers,” writes Dr. Marcelo Leite, a science journalist and former Nieman Fellow at Harvard University.
The debate about the connections of psychedelic culture to mysticism is also not new, Leite notes. “One of the pioneers of the so-called psychedelic renaissance, Roland Griffiths, saw his group at Johns Hopkins embroiled in a controversy over mystical leanings,” he says. “But it has not been demonstrated that religious or ideological beliefs engender the risk of abuse such as that suffered by Buisson.”
Lykos also stands to profit mightily from the approval of MDMA. In January of 2024, they announced that they raised $100 million in a Series A funding round. MAPS and Lykos also use “the potential to treat veterans as a selling point … to attract political and financial support from conservatives,” says Leite. “One of the opening speeches at the Denver conference, after Doblin’s, was that of former Republican Texas Governor Rick Perry, also a former Secretary of Energy under Donald Trump.”
However, veterans themselves have been vocal, active agents in these discussions, and have stepped forward to advocate strongly that MDMA and its associated psychotherapies be made available as a healing modality.
The Role of Touch
Questions about how therapists use touch in MDMA-AT arose in the AdComm meeting specifically. The treatment manual centers touch as an integral part of some healing processes and outlines occasions where touch may or may not be appropriate. Touch without consent or with inappropriate or sexual connotations is never allowed.
The manual states that touch “must always be used with a high level of attention and care, with proper preparation and communication, and with great respect for the participant’s needs and vulnerabilities.” In the inner-directive approach outlined, touch must be driven by the participant’s, rather than the therapist’s, needs.
MDMA therapists represent diverse clinical approaches to the use of touch in MDMA-AT. Holding the hand of a participant is common practice, and touch is understood as necessary to avoid neglecting the patient’s needs. The manual gives the example of nurturing touch, which occurs “when the participant is deeply re-connecting with times in life when they needed and did not get it,” as a potentially vital experience on the path to healing. In all instances where therapists employ touch, they must “take their cues about touch from the experience of the participant and … help the participant avoid the misconception that the therapists are the source, rather than the facilitators, of her/his therapeutic experience.” Therapists also must always adhere to their professional scope of practice in offering somatic interventions.
The use of touch must be consented to before the medicine sessions take place and must also be accompanied by a neutral safe word, such as “Stop,” that the participant chooses for use in the event that there is touch they do not want. “The participant should be told that this command will always be obeyed by the therapists unless the touch is necessary to protect the participant from physical harm” in order to “avoid confusion between communications that are meant to be directed to the therapists and statements that are expressions of the participant’s inner experience.”
Devenot also points to this as “a flawed model of consent” in the protocol. They elucidate this via an example shared by therapist Veronika Gold, M.A., MFT, taken out of context, explaining a ketamine-assisted psychotherapy session that included a “safe word.” At the AdComm meeting, Devenot shared a slide excerpting this example from the book Integral Psychedelic Therapy: The Non-Ordinary Art of Psychospiritual Healing, published by Routledge earlier this year.
“MDMA is also known for affecting verbal memory recall,” they say. “Expecting someone in a panic attack to remember a specific safe word decided on in an unaltered state, and to determine they were really interacting with their father” is problematic, they say, referring to Gold’s example.
“It’s critical for a client to understand why touch would ever be used,” Gold says. It requires the therapist to have “training and expertise, then really go through a consent process, including knowing whether a client can even consent, and knowing that people have different ways of saying no.”
Gold explains that the type of touch she references most in the chapter includes first inviting the client to work with themselves using somatic sensing and breathing. Following that, Gold invites them to breathe into their somatic experience. “And then, for example, if they feel a pressure on any part of their body, I ask whether they want to put their [own] hand on their body,” she says. “The next thing would be to offer touch at times when it clearly would be appropriate and helpful for the client. If I do offer the touch, then we check it out” through discussion and questioning. After that might come active touch, including gentle focused bodywork. This might be “an option for a patient to push against my hand,” followed by more check-ins, Gold explains.
“It’s a gentle way of allowing them to push while checking in with them. They always have the strength. You never overpower them.” The goal, she adds, is for them to have a sense of the movement that reconnects them with their own force.
Lykos investigated allegations from an unidentified source, which were brought up by Devenot in the AdComm about improper touch during a Phase 3 therapy session. Based on the information available to them and reports they were unable to substantiate Devenot’s claims. Lykos has a system for patients to report misconduct, and participants who feel they experienced misconduct are encouraged to reach out directly to the FDA to report it as well.
“We got to train about 100 therapists for Phase 3,” says Mithoefer, “and then we got to supervise them by watching the videos of their sessions and see what they were doing in great detail afterwards. And it’s a remarkable group of therapists. They are a very talented, educated and ethical group.”
From the beginning, says Mithoefer, “we’ve always said that we know our research has to be more rigorous than anyone else’s because it’s so controversial, and the idea that we’ve tried to obscure or cut corners is ridiculous. Rick [Doblin] has always said we need to look at the risks as well as benefits, knowing it’s the right thing to do, but also that it would be under great scrutiny.”
Although the FDA has given little public indication of how they are handling allegations, this does not mean they are doing nothing. “If FDA hears some kind of concern they can be expected to ask Lykos for data or do some kind of regulatory inspection that won’t necessarily be visible,” says Dr. Matthew Baggott, neuroscientist and CEO of Tactogen, a company working on a next generation of MDMA-like medicines. “They may not be able to talk about this with third parties since that would provide an opening for espionage-like activities between pharma companies. That is one reason I’ve suggested to participants in Lykos’ clinical trials who feel their experience isn’t reflected in the data that they should directly contact FDA as involved parties. FDA may be more responsive to them than to third parties.”
The public, however, “shouldn’t expect to hear anything from FDA regardless of what they’re doing in terms of getting to the bottom of allegations and concerns,” he continues. “It’s also possible that FDA already has audited the relevant data for some of these allegations, requesting data not just from specific participants but all data pertaining to the broader issues at hand.”
Continuing questions about therapy’s shortcomings may have made some companies move away from therapy and focus more on neuropharmacology. Compass Pathways limits the role therapists have “to ensure patient safety,” says Leite. Other researchers are looking most closely at “parapsychedelics,” which “dissociate [psychedelics’] biochemical action on the brain…from the subjective psychological experience.”
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Assessing the Therapy
Lykos’ standardized model of therapy is not the only one, and therapists would not be required to use it if MDMA were approved by the FDA, says Baggott. “The FDA has in the past approved medicines in conjunction with some other non-drug treatment,” he says, pointing to GLP-1 agonists like Wegovy, which was approved for weight loss “in combination with a weight loss program.”
“In such cases, they don’t necessarily try to nail down what the non-drug part of the treatment should be,” Baggott explains, “and they instead leave those details up to the treating physician. This is in part because healthcare is mainly regulated on a state rather than federal level.” There would, in the case of MDMA, he notes, be more oversight than with most drugs. This would come in the form of a REMS (Risk Evaluation and Mitigation Strategy) – an agreed-upon program between Lykos and the FDA designed to ensure that MDMA is being used safely. This might include things like a patient registry, which can help the FDA track problems if they occur, as well as a requirement that prescribing physicians and potentially other personnel receive special training to be aware of proper use of the medicine and potential issues to watch out for.
“That kind of thing will certainly be implemented,” he says, “but it seems unlikely to me that the REMS would include a significant focus on Lykos’ psychotherapy approach. Lykos had to write a manual to standardize therapy across sites during Phases 2 and 3, and they used the approaches that were most evidence-based at the time – ones that had been used in the psychedelic underground and by therapists when MDMA was still legal. Lykos was trying to be evidence-based to the best of their ability. But I think they are aware that much more work needs to be done to optimize the non-drug part of the treatment. Lykos will probably try to balance informing caregivers about what they did in the trials while also broadly supporting work to study other approaches and improve care.”
The Way Forward
In advance of the FDA’s decision, Lykos just announced new initiatives and measures for additional oversight of MDMA-AT, provided MDMA is approved. These include the creation of an independent advisory board that will inform key elements of a potential commercial launch, including therapist training and its delivery, ethics review, and healthcare integration; a plan to work with several selected “top-tier behavioral health centers” (the press release names Emory University, Sheppard Pratt, Sunstone, and several others) to support patient monitoring requirements and provide quality integrated care; and a pledge to collaborate with other institutions for therapist training.
Ultimately, only the FDA and Lykos have the full picture. Regardless of what they know, the public’s image of psychedelic-assisted therapy has been tarnished, and the stakes are high, as no new FDA-approved PTSD drugs have been available for over two decades.
Ultimately, only the FDA and Lykos have the full picture. Regardless of what they know, the public’s image of psychedelic-assisted therapy has been tarnished, and the stakes are high, as no new FDA-approved PTSD drugs have been available for over two decades.
One thing that is certain is the need for more research. “We have reasons to think MDMA can be really helpful for people with PTSD and other indications,” says Baggott. “The big question is how do we make this more reliable and enhance therapeutic benefits and minimize risks as much as possible? The Lykos trial only paired MDMA with one approach to therapy. We don’t know if other approaches could work better. As we move into other indications and different populations, it will be exciting to see what other therapeutic approaches might be better for patients.”
Baggott doubts the AdComm meeting will have significant ripple effects, although it did present a valuable case study for companies to learn from. Other companies developing psychedelics, he says, are likely to have taken notes on stated concerns and will take these into account when devising their own trials.
To Baggott, the AdComm meeting showed the FDA’s stance through the documentation they provided and the comments they made, which included critiques of functional unblinding and Lykos’s failure to collect data on “adverse events related to abuse potential…if they were deemed positive, favorable, or neutral,” and a proposed REMS. “We have a lot of insight into how they are evaluating this class of medicine that we didn’t have before,” he adds.
He also notes that ICER’s findings were not surprising. “ICER often doesn’t find that new treatments are cost effective,” he says. “In many ways, the goal of the organization is to lower the cost of medicines – in part by giving ammunition to the payer side so they can negotiate from a stronger hand. You expect them to be negative for new treatments and then potentially become more positive over time as more data gets presented.”
While clinical investigators on the trials are prohibited from speculating about whether MDMA will be approved, Gorman says that he feels “confident in the data we collected, the integrity of the trial at my site, and my hope is that the FDA will stick with the science and the results of their inspection to make their decision.”
Recognizing the growing interest in psychedelic therapies, the FDA published considerations for clinical investigations of psychedelic drugs in June of 2023. While those considerations were released well before the decision they will make in just a few days, they do show that the path forward, however rocky it seems at the moment, may one day be well-trodden.
Disclosure Note: Dr. Beatriz Caiuby Labate, Chacruna’s co-founder and executive director, is a part-time employee of MAPS. This article does not necessarily represent the views of Dr. Labate, Chacruna or MAPS.
Art by Karina Alvarez.
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