Issues of Patient Safety and Ethical Violations in Psychedelic Therapy

Psychedelic-Assisted Psychotherapy

Psychedelic-assisted psychotherapy, or PAP, is a practice that uses psychedelic compounds like lysergic acid diethylamide (LSD), psilocybin or entactogens like 3,4-methylenedioxymethamphetamine (MDMA) combined with guidance from a therapist over a few sessions to enhance responsiveness to psychiatric treatment.¹ Most recently, it’s been used as a potential therapeutic tool for the treatment of end-of-life associated anxiety or depression, major depressive disorder, and post-traumatic stress disorder (PTSD).^2-5

Typically PAP will have drug-free sessions before and after the drug-assisted sessions, usually called preparatory and integrative psychotherapy, respectively.^1,6 The goal of PAP is to produce a pharmacological effect on the brain, which in turn lowers inhibitions allowing the patient to feel introspective and enhance feelings of trust and closeness with the therapist. PAP, specifically with MDMA, is thought to be most effective for PTSD in part because it allows a person to feel empathy and openness that may facilitate conversations without negative reactions.⁷ MDMA-assisted psychotherapy is currently in phase II and III clinical trials in both the United States and Canada, spearheaded by the Multidisciplinary Association for Psychedelic Studies (MAPS). MDMA-assisted psychotherapy for the treatment of PTSD was granted Breakthrough Therapy Designation by the FDA in 2017.⁸

Ethics and Training in Psychedelic Therapy

Ethics are a fundamental cornerstone to psychiatry. The American Psychiatric Association has a strict code of ethics similar to the American Medical Association, which any person practicing psychiatry, counseling, or therapy must uphold.⁹ Over the last year, there has been a call for accountability within the psychedelic research space, largely due to New York Magazine’s “Cover Story: Power Trip” podcast, which exposed multiple concerns related to ethics and patient safety.

One of these concerns goes back to the training of psychedelic therapists. Training certifications to practice psychedelic-assisted therapy are typically given through an institution or an organization, whether that be non-profit organizations or through research institutions. There are also some informal training networks that include training provided by those who identify as underground guides. Since the use of psychedelics is still federally illegal, there are no federal or state accreditation requirements for these certifications and there is no established psychedelic therapy practice. This is to say that all the training and therefore psychedelic therapies have different protocols and may make use of different therapeutic modalities. For example, some psychedelic therapists do cognitive behavioral therapy, while some may use meditation techniques. These therapeutic modalities have never been formally compared in an evidence-based study to decide which is best in combination with psychedelics, although varying approaches have been reported on separately.^10,11 Further, the American Psychiatric Association recently stated that there is currently inadequate evidence to endorse PAP. These trainings have not been approved by accredited institutions or regulatory agencies outside the scope of clinical trials.¹²

A large majority of psychedelic therapy training comes from or is in part based on the MAPS training manual for MDMA-assisted psychotherapy. The MAPS website openly shares all documents, training materials, and a Code of Ethics on their website for organizations to use for training.^13,14 Despite being a leading research institution in psychedelic therapy, they have had some issues with ethics and behavior of therapists. As recently reported by “Cover Story,” two of MAPS therapists, Donna Dryer and Richard Yensen, assaulted and had an inappropriate relationship with a study participant, Meaghan Buisson.^15,16 Since the abuse, tapes of Meaghan’s therapy sessions were released and concerns of ethical violations have only increased.¹⁶

MAPS also has involvement with other institutions such as the California Institute of Integral Studies (CIIS), which is another popular program for psychedelic therapy certification. The training consists of 6 modules over 150 hours, but only 5 hours are dedicated to ethics as a subsection of the “Therapeutic Competencies and Therapeutic Processes” module.¹⁷ Following the reporting related to “Cover Story,” CIIS has come under fire due to their alleged funneling of students into the underground to be trained by problematic teachers, as well as their affiliations with another training institution, the Center of Consciousness Medicine (CCM). CCM is another institution offering psychedelic education and training for both underground guides and therapists. Co-founded by Francoise Bourzat and Aharon Grossbard, the center’s training program has been suspended until 2023 due the two being reported for multiple ethical violations and a lawsuit.¹⁸ The Hakomi Institute, which is also intertwined with MAPS, CIIS, and CCM training programs, have revoked Bourzat’s certification following these allegations.¹⁹ Bourzat and Grossbard are no longer associated with CCM according to their statements.²⁰

Patient Safety Concerns

PAP provides a unique set of ethical and safety concerns because of the influence of psychedelics on the human psyche, presence of therapists during the experience, as well as enhanced power imbalances with patient and therapist due to the psychedelic effects. It has been reported extensively that psychedelics produce altered states of consciousness and increased suggestibility.²¹ The MAPS Code of Ethics has a section dedicated to special considerations for patients in non-ordinary states of consciousness, which states “participants in non-ordinary states of consciousness may be especially open to suggestion, manipulation, and exploitation; therefore, we acknowledge the need for increased attention to safety, sexual boundaries, and consent.”

Despite this code of ethics, complaints have been brought against MAPS following phase II and phase III clinical trials of MDMA-assisted therapy for PTSD in North America. Before beginning the trials, participants sign an informed consent document, in which participants are ensured that sessions will be monitored and reviewed for adherence to study protocols.^13,14 Despite these assurances in writing and the sessions being recorded and supposedly reviewed, non-consentual touching and sexual assault occurred in a phase II trial.^15,16 It has been reported that MAPS only looked at the recorded footage following public accusations of inappropriate behavior, despite their protocol stating sessions were monitored and would be reviewed.^15,16,22 MAPS has acknowledged this abuse of power, however the organization has not altered their policy of who can provide therapy in these clinical trials.²³

These are not the only patient safety concerns regarding these trials. Other issues have been brought to the forefront, including: lack of reporting suicidality in studies, dismissing participants’ mental health concerns, insufficient number of integration sessions, and lack of follow up.^22,24 This lack of follow up is not necessarily about participants wanting more MDMA sessions, but rather that participants did not feel they had proper information and education regarding the post-therapy process or the potential adverse effects following completion of their participation.

In response to the podcast, MAPS had encouraged participants to sign up for the long term follow up study, but have not responded to reports that at least one participant with negative experiences who wanted to participate was excluded.²² MAPS has also updated their website in response to anecdotal reports of patients and critical concerns about the research, including decreases in PTSD scale scores following PAP not being included in data sets. They state that “misrepresentations – and lack of familiarity with the subject matter – led to a substantially incomplete and inaccurate picture of the work” and addressed this by creating a Frequently Asked Questions section outlining the concerns.²³ Participants and advocates have voiced their continued concerns on social media and the news, stating they find this response to be inadequate and are pushing for further investigation.^22,24 The ongoing major concern of participants is that their negative data was not included in the clinical trial reports in the first place.

In October 2021, a multidisciplinary psychedelic ethics research group (“The Complainers”) composed a formal complaint to the United States Department of Health and Human Services and FDA’s Office of Compliance Oversight. In March 2022, this same complaint was filed to Health Canada.²² The FDA has not stated whether or not they have started an investigation, only that they cannot comment on the specific actions related to inquiry.²² The complaint did prompt Health Canada to investigate the ongoing clinical trials.²⁵

As of June 2022, the Health Canada investigation found an investigator-initiated trial of MDMA-assisted psychotherapy sponsored by the Remedy Institute to be in violation of good clinical practices including^25,26:

• Medical care and medical decisions for the trial were not under supervision of a qualified investigator
• Untrained staff
• Required information not submitted to Research Ethics Board
• Editing protocol without formal submission, not following protocol, and inconsistent protocol at this site
• Lack of consent of participants before beginning the trial
• Not maintaining proper study records

A study with MAPS as the primary sponsor was also investigated. The summary of the inspection described multiple problems including failing to implement systems and procedures to ensure the quality of the clinical trial, good clinical practices, and issues with completeness, accuracy, and availability of required records.²⁷ Presently, the study is still in compliant standing but corrective action has been ordered by Health Canada.²⁸

What Does This All Mean?

Psychedelic therapy is showing promise for treatment of PTSD and other psychiatric disorders, but the results have come into question following reports from participants about lack of patient safety as well as breaches of good clinical practices. While MAPS has issued several statements and updated their website,²³ there are concerns they have still not taken responsibility for harms caused to participants and to ensure safety moving forward.²²

As of July 2022, The Complainers responded to the Health Canada investigations by stating that the issues pertaining to misuse and abuse of power largely lie in the psychotherapy component of the treatment, which falls out of the scope of the regulatory agency and has not been reported to be under investigation by researchers or sponsors running the trials.²⁹ The group put it bluntly,

The potential for harm resulting from a potentiation of/synergy with poor, misguided, or ill-intended psychotherapy practices, combined with drugs that lower inhibition and increase suggestibility, cannot be ignored.

Due to the increasing popularity of PAP, many patients are seeking out clinical trials or other ways to use psychedelics with guides or therapists. With that increased demand, there are also increasing questions about scientific rigor, proper evidence-based protocols, and complete assurance of safety of participants. FDA approval is set to proceed in the United States within the next two years³⁰ and it is currently unknown whether regulatory agencies will be taking any steps to ensure these issues are addressed before approval.

This article was updated on September 6, 2022 to clarify MAPS’ lack of acknowledgement of reports that at least one participant was excluded from a long-term follow up study.

Alaina M. Jaster, BS

Alaina is a PhD student in pharmacology at Virginia Commonwealth University. Her research focuses on behavioral changes and circuitry of psychedelics involved in preclinical models of addiction and depression.

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