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).
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 ♡
So well said, thank you for sharing these important points!!
Thanks Eliza! 🙏
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).
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 ♡