Health Canada announces review of all MDMA trials, as complaint alleges major flaws and safety issues

[S.J.B.]

Health Canada announces review of all MDMA trials, as complaint alleges major flaws and safety issues
Bethany Lindsay
CBC
April 8th, 2022

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.

Read the full story here.

 

[arrall]

The footage shared from one of the trials seems VERY concerning.

I have used MDMA outside of a formal therapy setting to treat my CPTSD. While I am extremely supportive of MDMA as a treatment for PTSD, this is not the first time that there have been issues with MAPS Canada therapists.

I predict that this investigation will probably show that MAPS needs to get its shit together in terms of therapist selection and protocols restricting physical touch and pushing participants to confront trauma -at least the division up here in Canada- while also showing that MDMA does indeed have incredible efficacy for PTSD. That IS what the subjects seem to think:

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.

 

[thegreenhand]

Quite frankly, I detest MAPS as an organization.

Maybe I shouldn’t say that since Bluelight is affiliated with them, but it’s how I feel

In my view, they covered up the sexual assaults that happened during one of the MDMA trials. It’s damn near impossible, however, to find media coverage of the events. But there’s plenty in mainstream media on how the organization is revolutionizing mental health care. Which btw I don’t deny, it’s an incredible advancement in psychiatry, but you can’t ignore abuse like that.

Abuse that, in my opinion, is somewhat systemic in certain psychedelic communities

This article is obviously about other concerns, but i guess it just goes to show there may be multiple problems to solve before going forward.