The FDA is approving a therapeutic component. The FDA has been put in position to not only approve a drug but a therapeutic intervention. MAPS set themselves up for failure by being sloppy in their research design. Nese Devenot is one person who has pointed this out. Also. Eliza if you read the MAPS therapy training manual it’s very clear that it was done with concepts that don’t align with conventional understanding of trauma integration. Nothing remotely evidenced based about what MAPS has proposed as a mechanism of efficacy. Is the FDA suppose to approve a therapeutic intervention based on ‘anything a therapist feels like doing?’ If MAPS didn’t want their therapeutic component scrutinized, they shouldn’t have included it as part of the clinical trial. The FDA cannot choose to willfully ignore this component. That would not be ethical or responsible.
Secondly, while many people have benefitted from MDMA, the hearing provided an opportunity for public input so that all stakeholders voices could be heard. You might not like what they said, but that’s part of a democratic process. Are you suggesting that only MAPS or industry leaders in the pharmaceutical space are is in a position to evaluate or provide an opinion about the study? MAPS has not been open to public scrutiny about safety concerns. I’m grateful that investigative journalists have picked up the story otherwise I’d never know what was actually happening behind the scenes at MAPS which had been unscrupulous and unethical in conduct.
As a survivor who has a history of sexual abuse and profound childhood trauma, I’d like to see MDMA approved. However, now that I have a greater understanding of the psychedelic field and the training of therapists as well as personal experience, it’s clear they’re not ready to roll this out. Thinking heads need to put their heads together to come up with a better protocol. Ketamine clinics that offer ketamine for complex PTSD (and soon to be MDMA) need to better than putting twenty something year old therapists out there to work with complex cases of chronic PTSD. Please note: most of the KAP therapist are new to their role as therapists. They don’t have the experience or training necessary to work with complex PTSD. And yet MAPS and the people that run clinics think all is going to be good because MDMA is that damn great? What about survivors that become suicidal? What about integration? I am stunned by how poor therapists conduct therapy and how very little they understand about PTSD. Are survivors left their own devices like what I’ve experienced with ketamine? What about accountability of psychedelic clinics? Where is the empowerment of clients or is this about the empowerment of the healer? Why did Veronika Gold hold down her client during the trial? That’s not acceptable behavior. Where are the safety guardrails? The FDA showing a little more caution, being a little more deliberate in issuing a ruling it’s a bad thing in my mind.
I also feel that it’s telling that complex PTSD has been left out of the conversation probably because the study was trying to control for dissociative features which in reality is impossible. I feel like survivors of childhood trauma were used as data points to bolster the data while actively used as guinea pigs in a trial to primarily benefit the VA. That’s really how the clinical trial was set up if you listen to interview between Rachel Yehuda and Bessel van der Kolk who both had considerable influence. They knew early on that MDMA has a greater positive reduction in CAPS if you only treat chronic PTSD in childhood trauma cases. This was noted in their interview. 80% of cases in the study fell into this category. If they had only included veterans in the study, their numbers wouldn’t have looked so great. But the emphasis on the approval process has been to overlook problematic aspects with data (such as the fact that this cannot be a blinded study, majority of subject already had taken MDMA before, Rick Doblin omitted adverse events and it’s hard to control for therapeutic component which really isn’t a evidenced based intervention or even a therapy in the strict sense of the word). The argument that was made was all of these problems should be overlooked because the need for veterans is so great and we need to support our veterans who have served this country. I’m appalled by use of this manipulative propaganda. What about survivors who have survived the war of their childhood? Here we have heard relative silence because the VA and veterans have raised a lot of money for the research. Who gets a voice at the table when money is involved?
Veterans and the VA have too much influence over the approval process. It’s not just about what veterans and the VA want, yet this special interest group was over represented in the committee meeting uncritically lauding the benefits without examining the content of the submission. If anything it was a veterans administration PR Blitz.
The FDA is approving a therapeutic component. The FDA has been put in position to not only approve a drug but a therapeutic intervention. MAPS set themselves up for failure by being sloppy in their research design. Nese Devenot is one person who has pointed this out. Also. Eliza if you read the MAPS therapy training manual it’s very clear that it was done with concepts that don’t align with conventional understanding of trauma integration. Nothing remotely evidenced based about what MAPS has proposed as a mechanism of efficacy. Is the FDA suppose to approve a therapeutic intervention based on ‘anything a therapist feels like doing?’ If MAPS didn’t want their therapeutic component scrutinized, they shouldn’t have included it as part of the clinical trial. The FDA cannot choose to willfully ignore this component. That would not be ethical or responsible.
Secondly, while many people have benefitted from MDMA, the hearing provided an opportunity for public input so that all stakeholders voices could be heard. You might not like what they said, but that’s part of a democratic process. Are you suggesting that only MAPS or industry leaders in the pharmaceutical space are is in a position to evaluate or provide an opinion about the study? MAPS has not been open to public scrutiny about safety concerns. I’m grateful that investigative journalists have picked up the story otherwise I’d never know what was actually happening behind the scenes at MAPS which had been unscrupulous and unethical in conduct.
As a survivor who has a history of sexual abuse and profound childhood trauma, I’d like to see MDMA approved. However, now that I have a greater understanding of the psychedelic field and the training of therapists as well as personal experience, it’s clear they’re not ready to roll this out. Thinking heads need to put their heads together to come up with a better protocol. Ketamine clinics that offer ketamine for complex PTSD (and soon to be MDMA) need to better than putting twenty something year old therapists out there to work with complex cases of chronic PTSD. Please note: most of the KAP therapist are new to their role as therapists. They don’t have the experience or training necessary to work with complex PTSD. And yet MAPS and the people that run clinics think all is going to be good because MDMA is that damn great? What about survivors that become suicidal? What about integration? I am stunned by how poor therapists conduct therapy and how very little they understand about PTSD. Are survivors left their own devices like what I’ve experienced with ketamine? What about accountability of psychedelic clinics? Where is the empowerment of clients or is this about the empowerment of the healer? Why did Veronika Gold hold down her client during the trial? That’s not acceptable behavior. Where are the safety guardrails? The FDA showing a little more caution, being a little more deliberate in issuing a ruling it’s a bad thing in my mind.
I also feel that it’s telling that complex PTSD has been left out of the conversation probably because the study was trying to control for dissociative features which in reality is impossible. I feel like survivors of childhood trauma were used as data points to bolster the data while actively used as guinea pigs in a trial to primarily benefit the VA. That’s really how the clinical trial was set up if you listen to interview between Rachel Yehuda and Bessel van der Kolk who both had considerable influence. They knew early on that MDMA has a greater positive reduction in CAPS if you only treat chronic PTSD in childhood trauma cases. This was noted in their interview. 80% of cases in the study fell into this category. If they had only included veterans in the study, their numbers wouldn’t have looked so great. But the emphasis on the approval process has been to overlook problematic aspects with data (such as the fact that this cannot be a blinded study, majority of subject already had taken MDMA before, Rick Doblin omitted adverse events and it’s hard to control for therapeutic component which really isn’t a evidenced based intervention or even a therapy in the strict sense of the word). The argument that was made was all of these problems should be overlooked because the need for veterans is so great and we need to support our veterans who have served this country. I’m appalled by use of this manipulative propaganda. What about survivors who have survived the war of their childhood? Here we have heard relative silence because the VA and veterans have raised a lot of money for the research. Who gets a voice at the table when money is involved?
Veterans and the VA have too much influence over the approval process. It’s not just about what veterans and the VA want, yet this special interest group was over represented in the committee meeting uncritically lauding the benefits without examining the content of the submission. If anything it was a veterans administration PR Blitz.
So well said, thank you for sharing these important points!!
Thanks Eliza! 🙏