Health Canada Announces Review Of All Mdma Trials As Complaint Alleges Major Flaws And Safety Issues

The complaint about Health Canada-approved trials conducted by the U.S.-based Mental Science Association (MAPS) was submitted to the federal service on March 4 by a team of academics and journalists. Health Canada confirmed Wednesday that it is now reviewing all tests involving MDMA to ensure patient safety and compliance. One of the signatories to the complaint is Emma Tumilty, a bioethicist at Deakin University in Australia. She said she was shocked by some of the things she learned about the MAPS tests. “I think there are other actors in this area who are trying to design studies to keep people safe and to see if it really works and to look at it properly,” he said. “But I believe that MAPS needs to be rewritten and seriously considered as a good science and an ethical science.” The complaint, which was examined by the CBC, touches on a news that was released video showing two therapists pushing with a spoon and pinning a distressed patient. He also goes so far as to claim that some test participants developed increasingly suicidal feelings that were not documented as adverse events and claimed that MAPS combined inappropriate data from small study sites that used different methodologies to produce favorable results. The complaint calls on Health Canada to “consider possible interventions to address the possibility of serious and permanent damage”. A Health Canada spokesman told the CBC in an email this week that the department was actively reviewing the complaint information and reviewing the tests would “ensure that the use of MDMA in the clinical trial continues to not endanger the health of the test participants.” , remains in the interest of the participants and remains in compliance with Canada Food and Drug Regulations. “ Priority in the Health Canada review will be on-site inspections, the spokesman said.

“I would not throw the baby out with the bath water”

Although they share many of the concerns raised in the complaint, study participants who spoke to CBC about their experiences said they believed MDMA could help relieve PTSD and wanted to see rigorous research into possible assisted treatment. from drugs. “I would not throw the baby out with the bath water,” said Petr Kopet, who took part in a Phase II test in Vancouver. A Canadian in a Phase III trial who said their experience left them in a “very bad position” also believes in the drug’s potential. “There is little doubt in my mind, in fact, that MDMA is really useful,” they said. The CBC agreed not to name them because of the sensitive nature of the medical information they disclosed. They said they now use MDMA illegally taken at home on their own and have found it to be curative without the presence of therapists constantly pressuring them to deal with their trauma, no matter how painful. “Having agencies around what I want to do and when it was much more effective in terms of wound healing, where you have no power and no choice and your limits are completely exceeded,” they said. .

MAPS stands for research

MAPS described many of the criticisms of the complaint as inaccurate and based in part on “lack of familiarity with the subject. “ Spokeswoman Betty Aldworth wrote in an email: “We are constantly evaluating drug training and development programs, making adjustments as appropriate to help maximize the safety and benefit to participants.” The complaint comes at a time when psychedelic drugs are becoming increasingly mainstream and substances such as MDMA — often known as ecstasy or molly — are hailed as miraculous drugs for serious psychiatric disorders. The Multidisciplinary Association for Psychedelic Studies is investigating the use of MDMA-assisted psychotherapy to treat post-traumatic stress disorder. (SkazovD / Shutterstock)
Much of the complaint information was obtained during the investigation by the back team New York podcast of the magazine “Cover Story: Power Trip”, which explores the growing field of psychedelic therapy. Co-presenter Lily Kay Ross filed the complaint with Health Canada after reviewing test data, talking to experts and hearing from participants about their experiences. Ross said she believes it is necessary to curb the rush to legitimize MDMA for use in psychotherapy until the security measures and data are more stable. “I think if there is any possible hope for that, it would require us to take a huge step back in research,” he said.

“I was so convinced of the miraculous cure”

One of the most serious allegations in the complaint is that some participants became more and more suicidal during the trials and these experiences were not all included in the reported MAPS results. The CBC spoke with two Canadian participants who said they experienced a sharp rise in suicidal ideation during or immediately after the trials. This includes Kopet, who said he had to stop taking his antidepressants to participate. He said he did not experience the euphoric effects most people report after consuming MDMA or feeling confident 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 psychiatric ward of the hospital. Kopet claims that when he asked his therapists about this, he was told to “trust the procedure”. Only after he ignored their advice and returned to his medication did he improve, he said. Two people who took part in a Canadian trial for MDMA-assisted psychotherapy told CBC that they were experiencing escalating suicidal thoughts. (suriyachan / Shutterstock)
Meanwhile, the participant in the Phase III trial described his three experimental sessions for MDMA as intense trials, where too much trauma healed very quickly. They also opened up to other unresolved wounds that had not caused problems in the past, they said, and new symptoms appeared. By the time the sessions were over, they were no longer registered as having PTSD according to the scale used by MAPS, but things ended so abruptly that they felt like they had fallen off a cliff. The treatment had also created strong feelings of dependence on their therapists, they said. They felt increasingly suicidal in the months following the end of the trial, but MAPS did not provide support for it – or a way of reporting their worsening symptoms. “If someone asked me, I was so protective of the trial and so protective of my therapists, I was so convinced of the miraculous cure that I would say I was healed,” they said. Looking back on these months after the trial, they describe that they feel brainwashed. “I was also actively committing suicide and had really serious PTSD symptoms and I was really, in hindsight, being compensated psychiatrically,” they said. Aldworth, a spokesman for MAPS, said the body monitors suicidal ideation and suicidal behavior and records any side effects reported by participants during the trials. “Used, unverifiable jokes by a small number of people are not a valid reason to modify the protocols,” he wrote.

“It is very low evidence”

Much of the complaint is based on the summary of MAPS results from Phase II, part of a clinical trial evaluating drugs to determine if they are safe and have a human effect. The document, obtained from participant Meaghan Buisson, shows that MAPS collected data from several small study sites around the world, some with just four patients. These sites used a variety of doses, different admission criteria for participants, different placebo and different number of sessions, while allowing therapists to use a range of therapeutic techniques. Hiking guide Meaghan Buisson received Phase II clinical data from MAPS following a complaint of sexual assault against the couple who underwent MDMA sessions. (Bethany Lindsay / CBC)
Tumilty, a bioethicist, has been a member of ethics committees and institutional review committees reviewing clinical trials and said she was shocked by what she saw. “These are very low figures,” he said. “I have not encountered heterogeneous data collected in the past in my work and I have not seen it published.” Without consistent methodologies and much larger sample sizes, Tumilty argues that it is very difficult to draw conclusions about the cause of any improvement in PTSD symptoms. MAPS argues that the variation in the methodologies used in the Phase II trials was intended to “inform the effective design of the Phase III trials”, which generally involve much larger groups of people. Tumilty responded that while this may be true, it is still necessary to have a larger number of participants who use each protocol to determine which is best.

“It’s not a problem of two bad therapists”

The complaint also disputes whether enough was done to keep patients safe, pointing to video by MAPS sub-investigators Dr. Donna Dryer and Richard Yensen pin, hug, spoon and eye tie participant Meaghan Buisson during pilot sessions in Vancouver in 2015. The videos were recorded by MAPS to make sure the therapists followed the accepted protocol and that the patients were safe. However, MAPS staff watched the videos only six years after they were taken and more than two years after Buisson filed a sexual assault complaint against Yensen with the organization. “It’s not a problem of two bad therapists. This is a system that exists and allows people like Richard Yensen and Donna Dryer to be in these treatment rooms and do what they did,” Buisson told a … .

title: “Health Canada Announces Review Of All Mdma Trials As Complaint Alleges Major Flaws And Safety Issues " ShowToc: true date: “2022-11-06” author: “Diana Lanterman”

The complaint about Health Canada-approved trials conducted by the U.S.-based Mental Science Association (MAPS) was submitted to the federal service on March 4 by a team of academics and journalists. Health Canada confirmed Wednesday that it is now reviewing all tests involving MDMA to ensure patient safety and compliance. One of the signatories to the complaint is Emma Tumilty, a bioethicist at Deakin University in Australia. She said she was shocked by some of the things she learned about the MAPS tests. “I think there are other actors in this area who are trying to design studies to keep people safe and to see if it really works and to look at it properly,” he said. “But I believe that MAPS needs to be rewritten and seriously considered as a good science and an ethical science.” The complaint, which was examined by the CBC, touches on a news that was released video showing two therapists pushing with a spoon and pinning a distressed patient. He also goes so far as to claim that some test participants developed increasingly suicidal feelings that were not documented as adverse events and claimed that MAPS combined inappropriate data from small study sites that used different methodologies to produce favorable results. The complaint calls on Health Canada to “consider possible interventions to address the possibility of serious and permanent damage”. A Health Canada spokesman told the CBC in an email this week that the department was actively reviewing the complaint information and reviewing the tests would “ensure that the use of MDMA in the clinical trial continues to not endanger the health of the test participants.” , remains in the interest of the participants and remains in compliance with Canada Food and Drug Regulations. “ Priority in the Health Canada review will be on-site inspections, the spokesman said.

“I would not throw the baby out with the bath water”

Although they share many of the concerns raised in the complaint, study participants who spoke to CBC about their experiences said they believed MDMA could help relieve PTSD and wanted to see rigorous research into possible assisted treatment. from drugs. “I would not throw the baby out with the bath water,” said Petr Kopet, who took part in a Phase II test in Vancouver. A Canadian in a Phase III trial who said their experience left them in a “very bad position” also believes in the drug’s potential. “There is little doubt in my mind, in fact, that MDMA is really useful,” they said. The CBC agreed not to name them because of the sensitive nature of the medical information they disclosed. They said they now use MDMA illegally taken at home on their own and have found it to be curative without the presence of therapists constantly pressuring them to deal with their trauma, no matter how painful. “Having agencies around what I want to do and when it was much more effective in terms of wound healing, where you have no power and no choice and your limits are completely exceeded,” they said. .

MAPS stands for research

MAPS described many of the criticisms of the complaint as inaccurate and based in part on “lack of familiarity with the subject. “ Spokeswoman Betty Aldworth wrote in an email: “We are constantly evaluating drug training and development programs, making adjustments as appropriate to help maximize the safety and benefit to participants.” The complaint comes at a time when psychedelic drugs are becoming increasingly mainstream and substances such as MDMA — often known as ecstasy or molly — are hailed as miraculous drugs for serious psychiatric disorders. The Multidisciplinary Association for Psychedelic Studies is investigating the use of MDMA-assisted psychotherapy to treat post-traumatic stress disorder. (SkazovD / Shutterstock)
Much of the complaint information was obtained during the investigation by the back team New York podcast of the magazine “Cover Story: Power Trip”, which explores the growing field of psychedelic therapy. Co-presenter Lily Kay Ross filed the complaint with Health Canada after reviewing test data, talking to experts and hearing from participants about their experiences. Ross said she believes it is necessary to curb the rush to legitimize MDMA for use in psychotherapy until the security measures and data are more stable. “I think if there is any possible hope for that, it would require us to take a huge step back in research,” he said.

“I was so convinced of the miraculous cure”

One of the most serious allegations in the complaint is that some participants became more and more suicidal during the trials and these experiences were not all included in the reported MAPS results. The CBC spoke with two Canadian participants who said they experienced a sharp rise in suicidal ideation during or immediately after the trials. This includes Kopet, who said he had to stop taking his antidepressants to participate. He said he did not experience the euphoric effects most people report after consuming MDMA or feeling confident 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 psychiatric ward of the hospital. Kopet claims that when he asked his therapists about this, he was told to “trust the procedure”. Only after he ignored their advice and returned to his medication did he improve, he said. Two people who took part in a Canadian trial for MDMA-assisted psychotherapy told CBC that they were experiencing escalating suicidal thoughts. (suriyachan / Shutterstock)
Meanwhile, the participant in the Phase III trial described his three experimental sessions for MDMA as intense trials, where too much trauma healed very quickly. They also opened up to other unresolved wounds that had not caused problems in the past, they said, and new symptoms appeared. By the time the sessions were over, they were no longer registered as having PTSD according to the scale used by MAPS, but things ended so abruptly that they felt like they had fallen off a cliff. The treatment had also created strong feelings of dependence on their therapists, they said. They felt increasingly suicidal in the months following the end of the trial, but MAPS did not provide support for it – or a way of reporting their worsening symptoms. “If someone asked me, I was so protective of the trial and so protective of my therapists, I was so convinced of the miraculous cure that I would say I was healed,” they said. Looking back on these months after the trial, they describe that they feel brainwashed. “I was also actively committing suicide and had really serious PTSD symptoms and I was really, in hindsight, being compensated psychiatrically,” they said. Aldworth, a spokesman for MAPS, said the body monitors suicidal ideation and suicidal behavior and records any side effects reported by participants during the trials. “Used, unverifiable jokes by a small number of people are not a valid reason to modify the protocols,” he wrote.

“It is very low evidence”

Much of the complaint is based on the summary of MAPS results from Phase II, part of a clinical trial evaluating drugs to determine if they are safe and have a human effect. The document, obtained from participant Meaghan Buisson, shows that MAPS collected data from several small study sites around the world, some with just four patients. These sites used a variety of doses, different admission criteria for participants, different placebo and different number of sessions, while allowing therapists to use a range of therapeutic techniques. Hiking guide Meaghan Buisson received Phase II clinical data from MAPS following a complaint of sexual assault against the couple who underwent MDMA sessions. (Bethany Lindsay / CBC)
Tumilty, a bioethicist, has been a member of ethics committees and institutional review committees reviewing clinical trials and said she was shocked by what she saw. “These are very low figures,” he said. “I have not encountered heterogeneous data collected in the past in my work and I have not seen it published.” Without consistent methodologies and much larger sample sizes, Tumilty argues that it is very difficult to draw conclusions about the cause of any improvement in PTSD symptoms. MAPS argues that the variation in the methodologies used in the Phase II trials was intended to “inform the effective design of the Phase III trials”, which generally involve much larger groups of people. Tumilty responded that while this may be true, it is still necessary to have a larger number of participants who use each protocol to determine which is best.

“It’s not a problem of two bad therapists”

The complaint also disputes whether enough was done to keep patients safe, pointing to video by MAPS sub-investigators Dr. Donna Dryer and Richard Yensen pin, hug, spoon and eye tie participant Meaghan Buisson during pilot sessions in Vancouver in 2015. The videos were recorded by MAPS to make sure the therapists followed the accepted protocol and that the patients were safe. However, MAPS staff watched the videos only six years after they were taken and more than two years after Buisson filed a sexual assault complaint against Yensen with the organization. “It’s not a problem of two bad therapists. This is a system that exists and allows people like Richard Yensen and Donna Dryer to be in these treatment rooms and do what they did,” Buisson told a … .