Deficiancies in good clinical practices and accurate record keeping stops an MDMA clinical trial in its tracks
On June 22nd, Health Canada —an institution similar to the American FDA— halted an MDMA clinical trial currently underway in Canada, citing “concerns for participant safety.”
The Phase 2 trial, studying whether MDMA-assisted therapy can treat PTSD, was paused after an investigation by Health Canada revealed 12 issues with the trial. Some of these concerns include: a lack of proper training for the trial staff; a failure to implement systems and procedures to ensure that the MDMA was properly handled and stored; failing to get written informed consent from all trial participants before the trial; improperly changing the study protocol before receiving approval from Health Canada; and not conducting the clinical trial in accordance with the protocol.
The study —which is one of two MDMA clinical trials currently underway in Canada— is being sponsored by a mental health charity called the Remedy Institute. For their part, Remedy is defending their trial, while admitting that changes are necessary to continue.
Speaking to the CBC through email, Anne Wagner, founder of the Remedy Institute and an adjunct professor of psychology at Toronto Metropolitan University, said “All participants in our study have received the safe dosages of medication approved by Health Canada and the Research Ethics Board, as well as ethical psychotherapy under the supervision of a licensed psychologist.” Furthermore, Wagner made clear that no study participants had been harmed.
Despite this, Wagner also said that the Remedy Institute welcomed “Health Canada's observations, and we are actively working to address them by hiring a leading regulatory compliance consultancy, revising documentation and administrative procedures, and creating better audit trail processes.”
At this time it is unclear when —or whether— this Phase 2 trial will be able to resume operations. Right now, Health Canada judges it to be “non-compliant” with its standards, based on their 12 “observations.” If the 12 problems in the Remedy-sponsored trial are considered fixable, and the “leading regulatory compliance consultancy” group they hire can resolve them, hopefully we will see this trial back up and running in the not-too-distant future.
However, some of their transgressions —particularly the failure to obtain informed written consent from their patients— seem serious enough that the possibility of this trial being canceled outright seems plausible.
The Health Canada review of the trial —which ultimately resulted in its suspension— is the consequence of a complaint made to the regulatory body regarding a different MDMA for PTSD study. After the completion of that MAPS-sponsored trial, a group of former particpants, journalists and acedemics lodged a formal complaint which alleged, among other things: one case of sexual abuse; improper data presentation from a collection of different study sites which all had different methodologies; and a failure to report several instances of patients who became suicidal during the clinical trial.
While MAPS has denied any wrongdoing in this trial —read this story for more background into the scandal and MAPS response— in Canada regulators decided to err on the side of caution and review all current MDMA clinical trials in the country. This is what resulted in Health Canada reviewing and ultimately suspending Remedy’s trial.
For their part, MAPS is also currently sponsoring an MDMA-assisted therapy for PTSD clinical trial with sites in Canada. The Health Canada inspection of this Phase 2 trial yielded nine “observations” of problems within the trial. Some of these include: a failure to “implement systems and procedures to ensure the quality of the clinical trial;” a failure to “implement systems and procedures to train study staff;” and a failure to “implement systems and procedures to ensure equipment was maintained and calibrated.”
Despite this, the trial has been allowed to continue with some “corrective and preventive” changes, as it was judged to be “in compliance with Canadian regulations.” In other words, unlike the Remedy-sponsored trial, the problems found in the MAPS trial were judged to be fixable, without shutting it down. Now, according to the CBC, MAPS must “submit acceptable corrective and preventive actions to address all inspection observations.”
Taking a step back, at first glance this story appears to be bad news for psychedelic medicines. I, however, do not view as such.
While I am personally an advocate for psychedelic medicines and I hope to see them ultimately legalized, we need to ensure that the road we take towards that goal is built upon a foundation of ethics, good practices and science. If psychedelic medicines are legalized —in this case MDMA-therapy for PTSD— and at a later date it’s found that the studies that this legalization is built upon were faulty, it could not only reverse the legalization, but it also may set the whole psychedelics movement back by years.
Therefore, we need to ensure that our regulatory bodies —in this case Health Canada— are actively involved in the clinical trials, and rectifying any problems before the studies are completed. While this is a story about a clinical trial failing to live up to the necessary standards, it’s also a story about health regulators stepping in to right the ship before it goes off course, ruining the entire journey.
In the Great White North, we are lucky to have Health Canada playing an active role in the study of psychedelic medicines. While this may mean that from time-to-time they will step in and require modifications to a clinical trial, therefore delaying it, in the long-run it will also mean the quality of the scientific evidence found in such clinical trials is elevated. Then, when it comes time to decide whether to legalize these treatments, we can be sure that the highest quality science is the foundation of the decision.
Editor's Note: This story was updated on July 22nd to reflect Health Canada's decision to allow the MAPS sponsored MDMA-assisted therapy for PTSD trial to continue.
I am already really worried that our ability to study and use psychedelics will be repressed before their benefits can reach the millions who want/need them. Part of the problem is that media and those with legal access to MDMA and ketamine for use in clinical settings are touting them as psychedelics. These are not pure psychedelics. The proliferation of treatment centres offering MDMA and K as psychedelics increases the odds of these treatments getting negative public attention like this, which puts actual psychedelic research (using psilocybin/LSD) at risk. I have just written a blog post about my concerns. https://iamallwrite.com/2022/07/16/psychedelics-pose-threats-to-powerful-groups-with-vested-interests-we-need-to-support-initiatives-to-make-them-available-for-therapeutic-use/