Rick Doblin was arrogant and dismissal of his critics that pointed out legitimate issues during the trial. His attempt to parade veterans at the open FDA committee was an obviously PR stunt. Over and over again, we were reminded that “30 veterans die every day of suicide” as if that appeal, in and of itself was going to be enough to convince the FDA. MAPS was so naive about the drug approval process. As I know someone who works in the industry, it’s clear that MAPS knew little to nothing about submission process. They should have hired a CRO much earlier. They needed to have a quality and regulatory person on board earlier. They shouldn’t try to hide adverse effects as the FDA frowns on that kind of behavior. MAPS didn’t have their act together, but then tried to lay the blame at rogue ‘anti capitalist’ critics which is quite laughable. All their sycophants including Robin Carthart Harris came back with that same whiny complaint, the unpatriotic anti-capitalists who don’t like veterans did them in. No. That’s not true. Their own hubris, their own inability to take feedback, their naivety about the FDA submissions process and what it means to start up a biotech or pharmaceutical company is what did them in.
They all signed a letter (including site investigators associated with UCSF, Polaris and Sage Integrative) appealing to FDA to change their mind. Surely, the FDA made a big mistake. No. The FDA did not make big mistake as their primary mandate is PATIENT SAFETY. Why should the FDA be swayed by a bunch of site investigators who were primarily opportunistic, not experienced seasoned trauma informed professionals to be taken seriously. These clinics offer crappy psychotherapy services for ketamine as their psychotherapists know little to nothing about PTSD. These people, who are more concerned with social justice and getting pronouns correct than understanding primary trauma interventions, are going to roll out future MDMA services? I don’t think so. If you want to offer something to help people with PTSD, your psychotherapists should be experienced, licensed and able to offer the latest neuroscience based techniques for integration. “Hippy, trippy become a psychedelic therapist with 150 hours of training” and all the client needs I do is — “trust your inner healer” is total bullshit! And that’s the bogus, non scientific psychotherapy intervention that Mithoefer used to train scores of psychotherapists (trust whatever your intuition says, whstever you feel like doing in the moment) it was offered to FDA. Really? The FDA wouldn’t be able to see through that?
Asking the FDA to approve a non evidenced based psychotherapeutic intervention was a huge mistake. Mithoefer who stated he didn’t care if his malpractice attorney was disapproving of his practice of rolling around on the ground with his female patient while they’re taking psychedelics. (See: @https://substack.com/home/post/p-149470666 )People at MAPS — a real bunch of ethical folks! Can’t imagine how this laissez faire attitude regarding a patient’s heightened state of vulnerability and what ethical precautions and guidelines needs to be implemented in a regulated environment with licensed mental health professionals subject to malpractice would translate. It was a big mistake for MAPS not to be proactive address ethical and clinical trial issues earlier because it just ended up biting them in the ass in the end.
I had planned to participate in the trial as I am a survivor with complex PTSD history. Glad I never did. Ketamine has worked for me because I found a stellar provider with proper experience and expertise. Maybe psilocybin would work as well for me. MDMA isn’t the only game in town. Never good to put all your eggs in one basket. As an investor or a consumer of mental health services, one shoukd always be mindful of what will offer the best return on investment.
Rick Doblin was arrogant and dismissal of his critics that pointed out legitimate issues during the trial. His attempt to parade veterans at the open FDA committee was an obviously PR stunt. Over and over again, we were reminded that “30 veterans die every day of suicide” as if that appeal, in and of itself was going to be enough to convince the FDA. MAPS was so naive about the drug approval process. As I know someone who works in the industry, it’s clear that MAPS knew little to nothing about submission process. They should have hired a CRO much earlier. They needed to have a quality and regulatory person on board earlier. They shouldn’t try to hide adverse effects as the FDA frowns on that kind of behavior. MAPS didn’t have their act together, but then tried to lay the blame at rogue ‘anti capitalist’ critics which is quite laughable. All their sycophants including Robin Carthart Harris came back with that same whiny complaint, the unpatriotic anti-capitalists who don’t like veterans did them in. No. That’s not true. Their own hubris, their own inability to take feedback, their naivety about the FDA submissions process and what it means to start up a biotech or pharmaceutical company is what did them in.
They all signed a letter (including site investigators associated with UCSF, Polaris and Sage Integrative) appealing to FDA to change their mind. Surely, the FDA made a big mistake. No. The FDA did not make big mistake as their primary mandate is PATIENT SAFETY. Why should the FDA be swayed by a bunch of site investigators who were primarily opportunistic, not experienced seasoned trauma informed professionals to be taken seriously. These clinics offer crappy psychotherapy services for ketamine as their psychotherapists know little to nothing about PTSD. These people, who are more concerned with social justice and getting pronouns correct than understanding primary trauma interventions, are going to roll out future MDMA services? I don’t think so. If you want to offer something to help people with PTSD, your psychotherapists should be experienced, licensed and able to offer the latest neuroscience based techniques for integration. “Hippy, trippy become a psychedelic therapist with 150 hours of training” and all the client needs I do is — “trust your inner healer” is total bullshit! And that’s the bogus, non scientific psychotherapy intervention that Mithoefer used to train scores of psychotherapists (trust whatever your intuition says, whstever you feel like doing in the moment) it was offered to FDA. Really? The FDA wouldn’t be able to see through that?
Asking the FDA to approve a non evidenced based psychotherapeutic intervention was a huge mistake. Mithoefer who stated he didn’t care if his malpractice attorney was disapproving of his practice of rolling around on the ground with his female patient while they’re taking psychedelics. (See: @https://substack.com/home/post/p-149470666 )People at MAPS — a real bunch of ethical folks! Can’t imagine how this laissez faire attitude regarding a patient’s heightened state of vulnerability and what ethical precautions and guidelines needs to be implemented in a regulated environment with licensed mental health professionals subject to malpractice would translate. It was a big mistake for MAPS not to be proactive address ethical and clinical trial issues earlier because it just ended up biting them in the ass in the end.
I had planned to participate in the trial as I am a survivor with complex PTSD history. Glad I never did. Ketamine has worked for me because I found a stellar provider with proper experience and expertise. Maybe psilocybin would work as well for me. MDMA isn’t the only game in town. Never good to put all your eggs in one basket. As an investor or a consumer of mental health services, one shoukd always be mindful of what will offer the best return on investment.