We, the undersigned, call for the FDA to schedule an open advisory committee meeting on Lykos’ application for MDMA-assisted therapy for PTSD. It is imperative that this meeting prioritizes contributions from stakeholders who are concerned about the application’s shortcomings and risks.
The approval of a drug-psychotherapy combination would be precedent-setting for the FDA. This is a high-stakes decision with significant consequences. A public advisory committee meeting is essential to preserve the FDA’s mandate of protecting and promoting public health. As such, we call for the FDA to organize an advisory meeting for MDMA-assisted therapy (MDMA-AT) with an extended open public hearing (OPH).
The decision to extend the OPH beyond the minimum standard is at the discretion of the committee Chairperson. Given the novelty and public interest of this application, the OPH must include sufficient time for participants who can speak to the concerns identified in this petition.
We are aware that the FDA informed Lykos (formerly MAPS Public Benefit Corporation) of a planned meeting in June 2024, but this meeting was not publicly announced by the time of posting this petition. This advance notice allows Lykos to organize advocates in preparation for the meeting. Although the FDA stipulates that meetings must be publicly advertised at least 15 calendar days before the meeting date, other stakeholders should also be afforded the opportunity to prepare for this meeting. Additionally, given that some former clinical trial participants are disabled, advance notice is a reasonable accommodation for their full participation in the OPH. In light of strong public interest in FDA’s decision, this meeting should also be made available by webcast.
If the FDA convenes an advisory committee OPH without sufficient notice or time allotted for other stakeholders, the FDA would be risking public safety and favoring industry interests. While the minimum OPH duration is set at 1 hour, the committee Chairperson has wide latitude to establish a longer OPH schedule. The novelty of MDMA-AT necessitates an extended OPH due to a constellation of special factors, including:
1. Novelty of the drug application: Since MDMA is a psychedelic/entactogen, this application is the first in a new medicine class. As an additional novelty, the FDA has never considered a drug-psychotherapy hybrid application. Further, Lykos purports that MDMA-AT involves a new mechanism of action involving the “inner healing intelligence.” MAPS/Lykos’ protocols explicitly theorize that “surrendering” to the “inner healer” is “the method of therapeutic action.” This construct attributes healing to “ordinarily hidden spiritual dimensions of existence” that are accessed through non-ordinary states of consciousness (Grof, 2006).
2. Significant safety concerns: Evidence from multiple sources indicates that the sponsor has engaged in a pattern of systematic and deliberate omission of adverse events from the public record while minimizing documented harms. This creates “substantial concerns about the validity of the results” submitted to the FDA (ICER, 2024). Although we take no position on the ultimate approval of MDMA or MDMA-AT, we have serious concerns about the safety of the therapeutic adjunct to MDMA proposed by Lykos.
3. Unresolved scientific issues regarding safety/efficacy: The March 2024 Institute for Clinical and Economic Review (ICER) report catalogs numerous issues with MAPS/Lykos clinical trials, including issues with blinding, unvalidated uses of psychometric tools, boundary violations, and inadequate trial designs. As a result of these issues, trial reporting is “unlikely to represent all adverse effects” or to reflect actual treatment efficacy (ICER, 2024).
4. Strong public interest requiring transparency and public input: There are indications that coordinated industry narratives may be skewing public perception of MDMA-AT’s safety and efficacy. MAPS/Lykos employs former participants to engage in public relations and political lobbying campaigns, which raises concerns about the impartiality and objectivity of advocacy efforts. These concerns are heightened by reports from veterans who described feeling “used” as political pawns by MAPS/Lykos. There are also allegations that MAPS’s lobbying campaign was kickstarted by funds acquired through elder abuse employing the drug under review.
The urgency of convening an advisory committee meeting is also supported by the FDA’s own 2008 draft guidance document, which identifies three determining factors. If “one or more” of these factors is met, the issue “should generally be referred to an advisory committee.” All three factors are met by Lykos’ MDMA-AT application:
1. Is the matter at issue of such significant public interest that it would be highly beneficial to obtain the advice of an advisory committee as part of the agency’s regulatory decision-making process? — Yes. If approved, MDMA-AT would be offered to some of the most vulnerable patient groups. Applications for psychedelic-assisted therapy are also anticipated to be transdiagnostic, which means that marketing is anticipated for large cross-sections of the public. As a result, this matter holds significant public interest, and the FDA has a responsibility to ensure the safety of potential patients
2. Is the matter at issue so controversial that it would be highly beneficial to obtain the advice of an advisory committee as part of the agency’s regulatory decision-making process? — Yes. Lykos’ application is highly controversial due to evidence (reported below) of data fraud and systematic misreporting of adverse events. Lykos’ MDMA-AT protocol is also controversial due to concern that the therapy increases risks to participants.
3. Is there a special type of expertise that an advisory committee could provide that is needed for the agency to fully consider a matter? — Yes. Personal, professional, and financial conflicts of interest permeate the research at MAPS/Lykos. As a result, the FDA should solicit testimony from cross-disciplinary experts without such industry ties. The FDA should also hear from trial participants whose experiences are not reflected in official reports. The FDA should not rely on accounts from researchers who are personally and financially invested in the MAPS/Lykos spiritual ideology of the “inner healing intelligence.”
The stakes of this petition are emphasized by recent disclosures from a former MAPS PBC employee, who prefers to maintain anonymity at this juncture. The identity of the former employee is known to two of the undersigned authors, and we share this information with their consent. We consider the former employee’s accounts to be highly credible.
We believe that these accounts from the former MAPS PBC employee, combined with our collective research and personal experiences, are essential for understanding the implications of regulating the model of MDMA-AT proposed by Lykos. We emphasize that this petition is agnostic to the ultimate decision of the FDA on regulating MDMA-AT. However, we believe that the FDA and the public should be informed about the current evidence base for the proposed psychotherapeutic adjunct.
MAPS/Lykos are alleged to have an internal culture of silence that explains the organizations’ limited public acknowledgment of pervasive issues with MAPS/Lykos’ data collection and reporting, despite being known to many MAPS/Lykos employees. Accounts have described a “culture of fear” surrounding widely-recognized concerns about the organization’s operations.
These concerns include an organizational culture that normalized violations of IRB, HHS, and FDA regulations. An account provided by the former MAPS employee suggests that clinical trial investigators would phone Rick Doblin (then MAPS Executive Director) in the event of an incident so that Doblin could determine whether an adverse event should be reported. In turn, Doblin would often respond with justifications for why adverse events should not be filed.
In one account from a clinical trial session involving MDMA, a participant made a serious suicide attempt during a dosing session. Doblin reportedly instructed the investigators not to report the incident, since he attributed the suicide attempt to the participant’s personal circumstances rather than to the MDMA. Despite Doblin’s alleged instructions, this event would have qualified as an “unexpected serious adverse event related to the study” based on the definitions from 21 CFR 312.32(a) (FDA, 2023), which legally obligated MAPS to notify regulatory authorities within seven (7) calendar days. Further, according to the United States Department of Health and Human Services, this event would meet requirements for classification as an “unanticipated problem” or “unanticipated adverse event” and require reporting under HHS regulations at 45 CFR 46.103(a) and 46.103(b)(5) (HHS, 2018; HHS, 2007). In another alleged unreported incident, a participant was kept overnight for observation because they remained in a “regressed” state at the end of the MDMA dosing session.
In addition to the internal reports of unreported adverse events, Rick Doblin asserted during a March 2024 SXSW presentation that suicidality only increased in participants in the placebo groups. However, we are aware of records that Doblin was directly informed of increased suicidality in participants in the MDMA groups. We also note that on the public record, multiple participants have described increased suicidality attributable to MDMA therapy.
In another March 2024 panel at SXSW, Lykos CEO Amy Emerson described that increased suicidal ideation is “actually part of the process” involved in psychedelic therapy, but that the existing medical and regulatory systems need to be “taught” to embrace this.
Based on the preceding information, we cannot rule out the possibility that MAPS/Lykos manipulated clinical trial data to hide adverse events from regulatory agencies, motivated in part by a belief that these agencies would not understand that these adverse events are a necessary part of their MDMA-AT.
There are additional concerning signs of unacknowledged safety issues in the MAPS/Lykos therapy protocol itself, to the extent that several experts suggest that Lykos’ MDMA-AT protocols may increase the risk of harm from MDMA relative to other forms of therapeutic support. Multiple researchers have raised concerns that the protocol’s emphasis on the “inner healing intelligence” establishes a vocabulary for minimizing participant complaints when real harm is occurring. Multiple accounts of harm in MAPS's clinical trials have already been associated with the spiritually-rooted “inner healer” construct, which has never been scientifically validated.
The MAPS/Lykos therapeutic manual encourages patients to “let go” and “surrender” to the inner healing intelligence, which may amplify the risk of harm associated with increased openness and vulnerability from the effects of MDMA. Directing patients to let go of boundaries is not consistent with contemporary trauma-informed practice, which emphasizes building personal boundaries and increasing a sense of control in patients who have experienced trauma.
There are several well-documented cases of high-profile therapists who have exploited the increased vulnerability of patients in MDMA therapy, including incidents of entrapment, sexual abuse, and coercive control. In the aforementioned case of elder abuse, MAPS board chair Vicky Dulai sent records to George Sarlo’s family about his participation in a MAPS clinical trial. These records included the dates of three MDMA dosing sessions between September and December 2020. When Sarlo’s health care agent later requested his medical records, MAPS lawyers denied the existence of this trial. This incident raises concerns that clinical trial records might have been hidden, or that a MAPS clinical trial might have been faked as part of a sales pitch to a MAPS funder.
We hold serious concern that these allegations of entrapment, sexual abuse, and coercive control are directly connected to the organisational culture and psycho-spiritual beliefs around “healing” that are encoded in the MAPS/Lykos protocol. Aspects of the psycho-spiritual beliefs associated with the MAPS/Lykos protocol have been employed by high-control therapy groups, where patterns of harm have been linked to their framing of distress as a necessary component of healing and spiritual development.
Since the expertise necessary to evaluate these risks lies outside of the FDA’s purview, the FDA must solicit input from outside researchers in order to evaluate the full risks of this protocol. We urge the FDA to investigate the psychotherapeutic protocols while considering the application for MDMA-AT.
We also concur with the ICER report on the current evidence base for MDMA-AT. We do not have high confidence in the validity or accuracy of MAPS/Lykos’ reporting to FDA. While MDMA-AT may have potential therapeutic utility, there are numerous indications that Lykos’ experimental protocol poses significant risks to vulnerable patient groups.
The FDA must take action to ensure that this does not amount to another regulatory scandal like the opioid crisis, where widespread harm retroactively illuminated substantial regulatory failures. If the FDA again prioritizes industry interests over public health, the outcome could mirror the trajectory of OxyContin, which was also once promoted as a wonder drug offering relief from chronic suffering. If an unsafe therapeutic adjunct is sanctioned by the FDA, the resulting harm could result in corrective restrictions that ultimately limit MDMA’s potential utility as a therapeutic.
Even if MDMA-AT is approved, the FDA should hold a public hearing to discuss latitude on the psychotherapeutic component. As this petition illustrates, there are serious potential risks in tying the administration of MDMA to the Lykos protocol.
Signed by Authors:
Neşe Devenot, PhD, Senior Lecturer, Johns Hopkins University
Meaghan Buisson, Independent Researcher
Alaina M. Jaster, PhD, Virginia Commonwealth University
Kayla Greenstien, PhD Candidate, University of Sydney
Brian Pace, PhD, Lecturer, The Ohio State University
Other concerned parties who support a thorough vetting of the MAPS/Lykos MDMA-AT application by the FDA are encouraged to sign the petition below. See the full list of signatories here, updated periodically.
