Health Canada announces review of all MDMA trials, as complaint alleges major flaws and safety issues
PTSD patients say they have hope for the drug-assisted therapy, despite concerns about the research
Concerns about patient safety, reports of increased suicidal thinking, and allegations of flawed research are at the heart of a new complaint to Health Canada over the much-hyped clinical trials for the use of MDMA to treat post-traumatic stress disorder.
The complaint about Health Canada-approved trials conducted by the U.S.-based Multidisciplinary Association for Psychedelic Studies (MAPS) was submitted to the federal agency on March 4 by a group of academics and journalists.
Health Canada confirmed Wednesday that it's now reviewing all trials involving MDMA to ensure patient safety and compliance with regulations.
One of the signatories on the complaint is Emma Tumilty, a bioethicist at Deakin University in Australia. She said she was shocked by some of the things she's learned about the MAPS trials.
"I think there are other actors in this space trying to design studies to keep people safe and test whether this actually has an effect and look at it properly," she said.
"But I think MAPS needs to regroup and have a serious think about what doing good science, and ethical science, looks like."
The complaint, which CBC has reviewed, touches on a newly released video that shows two therapists spooning and pinning down a distressed patient.
It also goes further, alleging some trial participants developed increasingly suicidal feelings that were not documented as adverse events, and claiming MAPS improperly blended together data from small study sites that used different methodologies to produce favourable results.
The complaint asks for Health Canada to "consider any interventions possible to address the potential for serious and lasting harm."
A Health Canada spokesperson told CBC in an email this week that the department is actively reviewing the information in the complaint, and a review of the trials will "ensure that the use of MDMA in the clinical trial continues to not endanger the health of the trial participants, remains in the best interests of the participants and remains compliant with the Canadian Food and Drug Regulations."
The priority in Health Canada's review will be on-site inspections, the spokesperson said.
'I wouldn't throw the baby out with the bathwater'
Despite sharing many of the concerns raised in the complaint, study participants who spoke to CBC about their experiences said they believe in the potential for MDMA to help alleviate PTSD, and they want to see rigorous research into the potential drug-assisted therapy.
"I wouldn't throw the baby out with the bathwater," said Petr Kopet, who participated in Phase II trials in Vancouver.
A Canadian participant in Phase III trials who said their experience left them in a "really bad place" also believes in the drug's potential.
"There's little doubt in my mind, actually, that MDMA is really helpful," they said.
CBC has agreed not to name them because of the sensitive nature of the medical information they disclosed.
They said they now use illegally obtained MDMA at home alone, and have found it to be healing without the presence of therapists continually pushing them to confront their trauma, no matter how painful.
"To have agency around what I want to engage with and when has been far more effective in terms of healing from trauma, where you don't have agency and you don't have choice and your boundaries are completely blown through," they said.
MAPS defends research
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."
Spokesperson Betty Aldworth wrote in an email, "We continually evaluate our training and drug development programs, making adjustments as appropriate to help maximize safety and benefit to participants."
The complaint comes at a time when psychedelic drugs are becoming increasingly mainstream, and substances like MDMA — often known as ecstasy or molly — are being hailed as miracle drugs for serious psychiatric conditions.
Much of the information in the complaint 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 the trials, speaking with experts and hearing from participants about their experiences.
Ross said she believes it's necessary to pump the brakes on the rush to legalize MDMA for use in psychotherapy until safety measures and evidence are more solid.
"I think if there's any possible hope for this, it would require taking a massive step back in the research," she said.
'I was so convinced of the miracle cure'
One of the most serious allegations in the complaint 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.
That includes Kopet, who said he was required to stop taking his antidepressants to participate.
He said he didn't experience the euphoric effects that most people report after consuming MDMA, or the feeling of trust in his therapists, so the sessions had little effect. Meanwhile, his suicidal thoughts escalated to the point that he tried to be admitted to a hospital psychiatric ward.
Kopet alleges that when he raised this with his therapists, he was told to "trust the process." It was only after he ignored their advice and went back on his medication that he improved, he said.
Meanwhile, the Phase III trial participant described their three experimental sessions on MDMA as intense ordeals, where too much trauma was being processed too quickly. They were also opened up to other unresolved traumas that hadn't caused problems in the past, they said, and new symptoms emerged.
By the time the sessions were complete, they no longer registered as having PTSD according to the scale used by MAPS, but things ended so abruptly they felt like they'd been dropped off the edge of a cliff.
The treatment had also created intense feelings of dependency on their therapists, they said. They felt increasingly suicidal in the months after the trial ended, but MAPS did not provide support for that — or a way to report their worsening symptoms.
"If anybody asked me, I was so protective of the trial and was so protective of my therapists, I was so convinced of the miracle cure that … I'd say I was cured," they said.
Looking back to those months after the trial, they describe feeling brainwashed.
"I was also actively suicidal and having really severe PTSD symptoms and really, in retrospect, decompensating psychiatrically," they said.
Aldworth, the MAPS spokesperson, said the organization monitors for suicidal ideation and suicidal behaviour and records all incidents of adverse events that participants report during the trials.
"Secondhand, unverifiable anecdotes from a small number of people is not a valid reason to modify protocols," she wrote.
'It's very low evidence'
A large portion of the complaint is based on MAPS's summary of its results from Phase II, the portion of a clinical trial when drugs are assessed to determine if they are safe and have an effect on humans.
The document, obtained by participant Meaghan Buisson, shows that MAPS pooled data from several small study sites around the world, some with as few as four patients. Those sites used a variety of dosages, different admissions criteria for participants, different placebos and different numbers of sessions, while allowing therapists to use a range of therapeutic techniques.
Tumilty, the bioethicist, has been a member of ethics committees and institutional review boards reviewing clinical trials, and said she was shocked by what she saw.
"It's very low evidence," she said. "I haven't come across heterogeneous pooled data like that before in my work and seen it published."
Without consistent methodologies and much larger sample sizes, Tumilty argues it's very difficult to draw conclusions about the cause of any improvement in PTSD symptoms.
MAPS argues the variation in methodologies it used in Phase II trials was meant "to inform efficient design of Phase III trials," which generally involve much bigger groups of human subjects.
Tumilty countered that while that may be true, it's still necessary to have a larger number of participants using each protocol to determine which is best.
'Not a problem of two bad therapists'
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.
The videos were recorded by MAPS to make sure therapists were following the accepted protocol and patients were safe.
However, MAPS staff didn't watch the videos until six years after they were filmed, and more than two years after Buisson filed a sexual assault complaint against Yensen with the organization.
"This is not a problem of two bad therapists. This is a system that is in place that is allowing individuals such as Richard Yensen and Donna Dryer to be in those treatment rooms and to do what they did," Buisson said in a recent interview.
Tumilty argued the videos of the sessions should have been reviewed during the trials, but even if that wasn't possible, MAPS should have immediately reviewed them when allegations of misconduct were raised.
Aldworth said that for Phase III trials, videos of select sessions involving every participant will be reviewed.
MAPS issued a statement in 2019 acknowledging Yensen had an "inappropriate and unethical" sexual relationship with a study participant and saying it was cutting ties with the couple.
In response to the release of the videos last month, MAPS announced a compliance review and told CBC it has "provisionally determined that Yensen and Dryer substantially deviated from the MDMA-assisted Therapy Treatment Manual on several occasions during the treatment period."
Yensen and Dryer have not responded to requests for comment about the videos. Yensen has admitted to having sex with Buisson, but claimed it was consensual.
Hopes of 'toning down the hype'
The recent concerns about the research came as a shock to Pedram, a Montreal Phase II trial participant who had an overwhelmingly positive experience. CBC has agreed not to use his full name because of the sensitive nature of the medical information he disclosed.
He said he was distressed to learn about Buisson's experience, which he described as unacceptable, and concerned the fallout might stall research into a drug-assisted therapy that could potentially help many desperate people.
Pedram described his three experimental sessions as a steady progression toward feeling like life was worth living again.
He said he would have described himself as "cured" when his time in the trial ended in 2019. Now, he said, he views it as finally finding the right tools to deal with his trauma, something that will be a lifelong process.
"My life was the same, but the way I was looking at it was permanently changed," he said.
Pedram said he wants more people to be aware that while MDMA-assisted psychotherapy might help alleviate PTSD for some, it may not work for everyone, and it's certainly not a miracle cure.
"Maybe one of the positive things that could come out of the recent developments is that it's toning down the hype," he said.
ABOUT THE AUTHOR
