The Phase II trial in Toronto, sponsored by a mental health charity called the Remedy Institute, received 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 about participant safety.” The federal regulator inspection summary of June 6; identifies 12 concerns with the project, including failure to conduct the study according to the approved protocol, problems with quality control and staff training, and lack of informed written consent from participants. The report also states that medical care for the patients involved was done without the supervision of a qualified investigator. Anne Wagner, founder of the Remedy Institute and an assistant professor of psychology at Metropolitan University of Toronto, said her organization thought it was complying with Health Canada regulations, but now they understand changes are necessary. “We welcome Health Canada’s comments and are actively working to address them by hiring a leading regulatory compliance consulting firm, revising documentation and administrative procedures, and creating better trail control procedures,” Wagner wrote in an email. He said no study participants were injured. “All participants in our study have received safe doses of medication approved 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 tests involving MDMA in April, following a complaint by a group of academics, study participants and journalists about alleged sexual harassment by two researchers in Vancouver, possible flaws in the research to date and reports of increased suicidal ideation by some patients. Inspectors are still finalizing their findings on 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 website states “deficiencies were found in the conduct of the clinical trial in accordance with good clinical practice… [and] to the completeness, accuracy or availability of the required records’. The Health Canada spokesman said staff have also reviewed all applications for previously approved MDMA trials and found nothing in the plans for those studies to suggest safety issues or breaches of regulatory requirements.
The complaint raised many concerns about the investigation
The review comes at a time when psychedelic drugs are becoming more mainstream and have been hailed in some corners as miracle cures for serious psychiatric conditions. MDMA – a recreational drug also known as ecstasy or mollies – produces feelings of euphoria and enhances sensation and suggestion. Research to date has largely focused on its potential, when combined with psychotherapy, to treat PTSD. Much of the information in the complaint that preceded Health Canada’s review was obtained during an investigation by the team behind The New York Magazine Podcast “Cover Story: Power Trip,” which explores the growing field of psychedelic therapy. Co-host Lily Kay Ross filed the complaint with Health Canada after reviewing data from trials conducted by MAPS, speaking with experts and hearing from participants about their experiences. Three people who took part in Canadian trials of MDMA-assisted psychotherapy told the CBC they experienced escalating suicidal thoughts. (suriyachan/Shutterstock) MAPS characterized many of the criticisms in the complaint as inaccurate and based in part on “lack of familiarity with the subject.” The complaint alleges that MAPS improperly combined data from small study sites that used different methodologies to produce favorable results. One of the more serious claims is that some participants became increasingly suicidal during the trials, and these experiences were not all included in the reported results of MAPS. The CBC spoke to three Canadian participants who said they experienced a spike in suicidal thoughts during or immediately after the tests. The complaint also questions whether enough was done to keep patients safe, showing video of MAPS sub-investigators Drs. Donna Dryer and Richard Yensen pinning, cuddling, spooning and blindfolding participant Meaghan Buisson during experimental sessions in Vancouver in 2015. MAPS recorded the videos to make sure therapists were following accepted protocol and patients were safe, but the agency says staff only viewed the videos six years after they were taken. Yensen admitted to having sex with Buisson after the experimental sessions ended, but while she was still enrolled in the clinical trial. She has claimed it was sexual assaultbut Yensen maintains that the relationship was consensual. MAPS issued a statement in 2019 acknowledging that Yensen had an “inappropriate and immoral” sexual relationship with a study participant and said he was cutting ties with the couple.
