Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review

UPDATE Sept. 29, 2022: Health Canada confirmed that it has authorized the reinstatement of the Remedy Institute's clinical trial after determining that the necessary corrections to the study have been made.

Patient safety concerns uncovered during an ongoing federal review have led to the suspension of one of two clinical trials for MDMA-assisted psychotherapy currently underway in Canada.

The Phase II trial in Toronto, sponsored by a mental health charity called the Remedy Institute, was issued a non-compliant rating on June 22, according to Health Canada.

A spokesperson told CBC in an email that the study was put on hold "due to concerns for participant safety."

The federal regulator's summary of a June 6inspection identifies 12 concerns with the project, including a failure to conduct the study according to the approved protocol, problems with quality control and staff training, and a lack of informed written consent from participants.

The report card also says that medical care for the patients involved was happening without supervision from a qualified investigator.

Anne Wagner, founder of the Remedy Institute and an adjunct professor of psychology at Toronto Metropolitan University, said her organization had believed they were compliant with Health Canada regulations, but they now understandchanges are necessary.

"We welcome Health Canada's observations, and we are actively workingto address them by hiring a leading regulatory compliance consultancy, revising documentation and administrative procedures, and creating better audit trail processes," Wagner wrote in an email.

She said no study participants have been harmed.

"All participants in our study have received the safe dosages of medicationapproved by Health Canada and the Research Ethics Board, as well as ethical psychotherapy under the supervision of a licensed psychologist," Wagner said.

Health Canada promised a review of all trials involving MDMA in April, following a complaint from a group of academics, study participants and journalists about alleged sexual misconduct by two investigators in Vancouver, potential flaws in the research conducted to date and reports of increased suicidal thinking from some patients.

Inspectors are still finalizing their findings about the second active MDMA study site in Montreal, where a Phase II trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) is underway.

However, an initial summary of a June 6 inspection of the site says "deficiencies were noted in conducting the clinical trial in keeping with good clinical practices [and] in the completeness, accuracy or availability of the required records."

The Health Canada spokesperson said staff have also reviewed all applications for previously authorized MDMA trials and found nothing in the plans for those studies that suggested safety problems or violations of regulatory requirements.

Complaint raised several concerns about research

The review comes at a time when psychedelic drugs are becoming increasingly mainstream and have been hailed in some corners as miracle drugs for serious psychiatric conditions.

MDMA a recreational drug also known as ecstasy or molly produces feelings of euphoria and enhances sensation and suggestibility. Research to date has largely focused on its potential, when combined with psychotherapy, to treat post-traumatic stress disorder.

Much of the information in the complaint that preceded the Health Canada review was obtained during research by the team behind New York magazine's podcast "Cover Story: Power Trip," which explores the growing field of psychedelic therapy.

Co-host Lily Kay Ross submitted the complaint to Health Canada after reviewing data from trials conducted by MAPS, speaking with experts and hearing from participants about their experiences.

MAPS has characterized many of the criticisms in the complaint as inaccurate and based in part on "a lack of familiarity with the subject matter."

The complaint alleges that MAPS improperly blended data from small study sites that used different methodologies to produce favourable results.

One of the most serious allegations is that certain participants became increasingly suicidal during the course of the trials, and those experiences weren't all included in MAPS's reported results.

CBC has spoken to three Canadian participants who said they experienced a sharp spike in suicidal thoughts during or immediately after the trials.

The complaint also questions whether enough was done to keep patients safe, pointing to videos of MAPS sub-investigators Dr. Donna Dryer and Richard Yensen pinning down, cuddling, spooning and blindfolding participant Meaghan Buisson during experimental sessions in Vancouver in 2015.

MAPS recorded the videos to make sure therapists were following the accepted protocol and patients were safe, but the organization says staff didn't watch the videos until six years after they were filmed.

Yensen has admitted to having sex with Buisson after the experimental sessions ended, but while she was still enrolled in the clinical trial. She has alleged it was sexual assault, but Yensen argues the relationship was consensual.

MAPS issued a statement in 2019 acknowledging Yensen had an "inappropriate and unethical" sexual relationship with a study participant and said it was cutting ties with the couple.