This is a beautifully rational explanation of the committee's concerns. I agree that approval would regulate the current Wild West, which would be better for all patients.
Thank you for your thoughts. I have a few of my own. 1) I am not sure why we keep saying this is new and unknown. There were over 40,000 papers written on psychedelics throughout the 50's and 60's. I feel like everyone keeps talking like this is new research. Even the Lykos guide was inspired by Stan Grof, who was one of many using LSD in therapy. There were tens of thousands of people treated with LSD. It seems like that is just forgotten altogether. 2) I agree that we need to take caution, but if it is not the FDA's job to judge therapy, then why are they doing it? Even thought the application was for the combination of the two, it seems to me that their job is to ignore the therapy part altogether. 3) It seems a bit absurd that the FDA calls out the design of the study at the approval table; they were the ones who helped make the design. 4) A better design would have been 3 groups...a placebo, MDMA with no therapy, and MDMA with therapy. Just like some studies on SSRI's. 5) Now what? I have heard that it is being legally used in mainstream psychiatry in Australia. Is this true? Is this treatment available to those of us who still suffer and nothing else works? By flying to Australia? Many of us cannot afford to wait 5 more years for another trial.
Do i have this correct? FDA approved the structure of the study, fully recognizing this placebo issue at the time, then after the study is completed at great cost, the advisors reject it, stating the placebo issue as part of the reason. If the above is factual, will they reimburse the researchers for the cost of the study since they, in effect, changed the terms of a contract?
That is correct, and as someone currently contributing to a trial, it is a tremendously complex and intricate process to receive approval from the FDA in the first place. And alas, no reimbursement will be given, so more $5-15 million dollar studies will need to be done with new funding obtained.
We all know the promise of PAT, thats not in question. But, MAPS is a massive grift. That MAPS training, that everyones paid through the nose for, probably like your partner, is also part of the grift of MAPS. Would love to follow up when all of these people who have paid for their training will ever get to use it. It will probably be 5-10 years at least before anything outside of KAP is ever approved, and even then it's going to cost patients 10-15k per treatment. I honestly dont think PAT will ever become accessible to the general public in our lifetime as long as there's companies like MAPS.
If the FDA were to 'tease out' the efficacy of the 'therapy' when we combine the SSRI's with any modality of psychotherapy then all the same issues the FDA is raising and that you have elucidated would have applied. And the SSRI's would still be in research or have been abandoned. The problem is Rick Doblin and Lykos don't have the mega-bucks to do endless research on the nexus between the substance and the relationship between the client and psychedelic therapist(s. ) Such relationships are a huge part of any modality of psychotherapy. Most of the investigations into modes of psychotherapy have pointed out the importance of this relationship to the outcomes. The FDA doesn't regulate the safety of client-therapist relationships. That is the job of licensing boards. The FDA should focus on the chemical pharmacology and leave out the other factors as they do with all the other medications they regulate.
Some of your points are valid, but these trials included the psychotherapy as part of the intervention up for approval. Trials such as those for SSRI's have requested FDA approval for the medication only, without expectation that it only be delivered with a linked therapy intervention. They are not comparable situations.
@@livingmedicineinstitute But if the FDA does not evaluate therapy, then shouldn't that be ignored in their decision and just look at the data to judge its efficacy?
This is a beautifully rational explanation of the committee's concerns. I agree that approval would regulate the current Wild West, which would be better for all patients.
Thanks for the rational explanation Signi. I was eager to hear your thoughts on it.
Thank you for your thoughts. I have a few of my own. 1) I am not sure why we keep saying this is new and unknown. There were over 40,000 papers written on psychedelics throughout the 50's and 60's. I feel like everyone keeps talking like this is new research. Even the Lykos guide was inspired by Stan Grof, who was one of many using LSD in therapy. There were tens of thousands of people treated with LSD. It seems like that is just forgotten altogether. 2) I agree that we need to take caution, but if it is not the FDA's job to judge therapy, then why are they doing it? Even thought the application was for the combination of the two, it seems to me that their job is to ignore the therapy part altogether. 3) It seems a bit absurd that the FDA calls out the design of the study at the approval table; they were the ones who helped make the design. 4) A better design would have been 3 groups...a placebo, MDMA with no therapy, and MDMA with therapy. Just like some studies on SSRI's. 5) Now what? I have heard that it is being legally used in mainstream psychiatry in Australia. Is this true? Is this treatment available to those of us who still suffer and nothing else works? By flying to Australia? Many of us cannot afford to wait 5 more years for another trial.
Well-said
Do i have this correct?
FDA approved the structure of the study, fully recognizing this placebo issue at the time, then after the study is completed at great cost, the advisors reject it, stating the placebo issue as part of the reason.
If the above is factual, will they reimburse the researchers for the cost of the study since they, in effect, changed the terms of a contract?
That is correct, and as someone currently contributing to a trial, it is a tremendously complex and intricate process to receive approval from the FDA in the first place. And alas, no reimbursement will be given, so more $5-15 million dollar studies will need to be done with new funding obtained.
@@TheElan5in other words, some Big Pharma outfit will claim ownership over MDMA rather than MAPS
We all know the promise of PAT, thats not in question. But, MAPS is a massive grift. That MAPS training, that everyones paid through the nose for, probably like your partner, is also part of the grift of MAPS. Would love to follow up when all of these people who have paid for their training will ever get to use it. It will probably be 5-10 years at least before anything outside of KAP is ever approved, and even then it's going to cost patients 10-15k per treatment. I honestly dont think PAT will ever become accessible to the general public in our lifetime as long as there's companies like MAPS.
If the FDA were to 'tease out' the efficacy of the 'therapy' when we combine the SSRI's with any modality of psychotherapy then all the same issues the FDA is raising and that you have elucidated would have applied. And the SSRI's would still be in research or have been abandoned. The problem is Rick Doblin and Lykos don't have the mega-bucks to do endless research on the nexus between the substance and the relationship between the client and psychedelic therapist(s. ) Such relationships are a huge part of any modality of psychotherapy. Most of the investigations into modes of psychotherapy have pointed out the importance of this relationship to the outcomes. The FDA doesn't regulate the safety of client-therapist relationships. That is the job of licensing boards. The FDA should focus on the chemical pharmacology and leave out the other factors as they do with all the other medications they regulate.
Some of your points are valid, but these trials included the psychotherapy as part of the intervention up for approval. Trials such as those for SSRI's have requested FDA approval for the medication only, without expectation that it only be delivered with a linked therapy intervention. They are not comparable situations.
@@livingmedicineinstitute But if the FDA does not evaluate therapy, then shouldn't that be ignored in their decision and just look at the data to judge its efficacy?