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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.

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Anna, thank you so much for your thoughtful comment I am not sure how I missed it - so apologies for the delayed response. I resonate with much of what you're saying but let me touch on a few things:

1. Regulating the therapy: I agree with the notion that asking the FDA to regulate therapy (especially a "novel", unproven therapy model) was not smart. However, one has to note that MAPS collaboratively developed the protocol with the FDA over several years until the FDA signed off on it. So I wonder how much of MAPS' motivation to include therapy was aided by the FDA's seeming openness to it. I imagine here must have been some miscommunication.

2. Accounts of abuse: I'm 100% for transparency on any harm caused. What I don't think is fair, however, is to judge abuse that happened outside of the MAPS clinical trials. Some comments in the hearing came from people that had underground experiences with untrained guides at their own risk - this should not affect judgement of MDMA-AT, which MAPS proposed to be only administered under their trained guidance. So any harm outside the realm of the MAPS rained guidance should not influence the decision, in my opinion.

3. CPTSD: I believe the main reason that the trials are on PTSD rather than CPTSD is a technical one - CPTSD is still not a formally recognized diagnosis in the DSM, psychiatry's bible. So it would not be commercially viable for any organizations to invest millions into clinical research, since treatments can only be reimbursed by insurance if there's a code providers can bill to. CPTSD does not have such a code. I imagine there will be off-label use for CPTSD (privately paid; until it becomes an official diagnoses) - but it was not a viable path for MAPS or any other psychedelic research org. I'm a also a surviver of both SA and CPTSD and I totally relate to your sentiment though, both these patient populations are probably the most in need.

4. VA: I hear you on veterans being over-represented. So much of it is public perception. When people hear about the MAPS PTSD trials they automatically think of veterans, when in reality there were only small share of them in the studies, the vast majority was victims of sexual trauma (mostly women). The truth is that politically, there is much more care for veterans than female victims of sexual abuse. Veteran mental health is a national interest that is one of the very few topics that is bipartisan - as such it is a huge lever for policy change. That's why I personally dedicated the last 2 years to supporting a veteran MDMA non-profit, because I believe that this will pave the way for the huge number of SA victims. I wish there was a more direct path, but there isn't, this seems to be the most effective strategy after much contemplation. And it is the intent of our non-profit to shift to new patient populations such as women with SA as soon as the VA has greenlit the treatment.

I'm grateful for your commentary. We could probably have hour-long conversations about all of this. Ketamine is quite the debacle too, as you noted, it's definitely not a success story. The field will have a steep learning curve (I hope), but it will be at the expense of individuals who don't initially get the treatment they deserve (I fear).

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Aug 6Edited

Hello Julia — No worries about delayed response. I realize I wrote a very long comment. I’m aiming for breviety — however — there’s a lot going on now in the psychedelic space and I have a lot of thoughts. I probably be better off posting from my own publication. Thank you for allowing me this space to express my thoughts and concerns.

1) In response to your thoughts on Regulating the therapy: What you say sounds sensible. It’s hard to know exactly what’s happening at the FDA level. I imagine they are challenged by the psychotherapy component. Maybe they signed off on it without fully thinking through the implications. That would be their mistake. But what’s more problematic, in my mind, is the fact that MAPS proposed this protocol knowing full well that people with severe trauma histories would be subject to a so called psychotherapy developed in the underground. There are absolutely no mainstream trauma therapists that use this protocol to integrate trauma. Telling a survivor with severe trauma history (which includes me!) to trust your inner healer and ‘it’s could get worse before it gets better’ and you could become suicidal (oh well) is not reassuring, it’s not responsible, it’s not reparative, it’s not relational psychotherapy. It does not align with work of Stephen Porges or Dan Siegel or Laura Parnell (EMDR) or Richard Schwartz (IFS) any dozen of people I could name. The MAPS training manual is suggestive, not prescriptive. Dr. Bessel van der Kolk and Dr. Rachel Yehuda could have intervened earlier as I think they know better. But as they’re tight with Doblin and Michoeffers — they seemed hell bent on pushing the envelope — “fake it til you make’ it mentality — as money and professional reputation of researchers was on the line.

I wonder what legitimate trauma therapists were brought in for consultation. You think they’d strive for some consensus building and leverage talent which already exists within the field — but they were aiming for efficiency which doesn’t always result in effectiveness. I’m not so sure it was miscommunication. Again, I’m speculating. But after listening to some of the FDA committee meeting and coverage, it’s clear that the FDA is under the false impression that veteran PTSD is treated the same as complex PTSD (or childhood or relational trauma). It’s not. They had scientists, pharmacists and psychiatrists weighing in. How can they be expected to evaluate what will be standard complex trauma therapeutic intervention if they know nothing or little about CPTSD. I guess a MAPS training manual looks good to them as does CAP5 evaluative measure. One standard treatment

I understand that complex trauma is not an official diagnosis and that’s a huge problem thanks to Dr. Jeffrey Lieberman and friends. We’re now really seeing the repercussions of the DSM committees’ decision not to approve developmental trauma diagnosis. Survivors are suffering because of this decision.

At the same time, MAPS/Lykos could show a little more sensitivity around the issue of inclusion, more emphasis on women’s issues as it relates to sexual abuse even though feminism seems to be an antiquated concept with BIPOC and LGBQT2S being at the forefront of political debate. There’s just not enough room at the table it seems.

I have looked at several sites with practitioners that anticipate offering MDMA in the near future and I’ve reached out to a number of practitioners as I’m engaged in ketamine treatment. I’m absolutely mortified by their lack of experience and understanding of complex PTSD. This is why I will most likely never try MDMA because I don’t trust the practitioners. If these clinics think they’re prepared to offer servics to people with severe trauma histories, they’re clearly delusional.

In response to your comments regarding CPTSD: Yes. CPTSD is not a formal diagnosis. And I understand the commercial viability issue. They’ve also been leaning heavily on the VA for money. See Rachel Yehuda’s research. This has been a political issue for years which Bessel van der Kolk has tried for decades (mostly in vein) to champion: more research and money devoted to developmental trauma research. Government agencies and politicians and the general public doesn’t seem to see that social issues are something that should be funded.

I don’t imagine that it will be ‘off label’ as CPTSD is now being diagnosed as chronic PTSD by psychiatrists as a work around. Wish I could be hopeful for update to DSM — but I don’t see it for reasons connected to the APA that I won’t elaborate here.

I do appreciate your big picture analysis as what we’re discussing is bigger than MAPS/Lykos itself. We can’t fundamentally fix a broken institutional system without political will.

You have a very pragmatic attitude. I see you are also a survivor like myself. I do empathize with veterans and the rhetoric wears very thin. It’s been triggering because I personally viscerally feel the injustice as someone who feels they haven’t been seen, heard or known. And as you probably know, to explain to someone that you have PTSD is much easier to convey if your a veteran as opposed to survivor of major childhood traumas such as physical, emotional and sexual abuse. It’s not something most people can wrap their heads around. The false memories movement and Elizabeth Loftus and Aaron Beck (CBT founder) were not helpful in that regard.

Regarding VA: I appreciate your political perspective here. Given our ever increasingly polarized political landscape, it feels refreshing to imagine an issue where both sides can meet to work on policy.

It’s admirable that you’ve found a way to give purpose to your life by working with a non profit. I hope it does help SA survivors in the future. Looks like you’ve got vision and hope for a brighter future. (Maybe I’m just too old, burned out and cynical at this point 😂)

We probably could have long conversation. Thank you again for responding to my long commentary.

I'm grateful for your commentary.

Ketamine would be another conversation for sure! And I can say it’s helped me a lot as I found a great clinic that offers trauma integration services. As much as it’s extremely difficult — there’s nothing else that compares to this treatment I think, if it’s done with adequate care and support — not just an IV drip line as your relational object.

The field’s steep learning curve will be the greatest challenge as demand, I suspect, will exceed supply. Lots of cutting corners to make treatment affordable. We see that with mail order ketamine already. I also worry about people becoming addicted through microdosing. More and more to discuss.

Best luck with your work.

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Thanks for sharing, Anna. I resonate with much of what you're saying and totally hear your frustrations. I do have to say, though, that medicalized psychedelic therapy is not the only path. My recovery involved underground ceremonies with different medicines, psychedelic integration coaching, traditional therapy, somatic therapy and even a 6-week intensive outpatient program -- and with all of that, I was able to recover from the symptoms of CPTSD (which for me was addiction and depression). Every once in a while something will flare up (only felt states though, no behaviors) - I have certain sensitivities and "parts" that I've learned (and am still learning) to regulate and soothe, and I never even had any MDMA-assisted therapy. I'm only saying this because aside from all the systemic issues, I'm hopeful that you on an individual level will find a way to assemble your own recovery (it sounds like you are?). I'm happy to share more if you're curious, it's a big topic that I touch on here and there but maybe you've already found what works for you and then it wouldn't be necessary to share more. All the best ♡

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So well said, thank you for sharing these important points!!

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Thanks Eliza! 🙏

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