Yeaaaaah, that advisory committee meeting ...
I was watching and the chair stumbled over the name midomafetamine repeatedly. I don't think he got it right once. Clearly well informed. sarcasm Those big pharma simps also were not comfortable with any concepts that weren't covered in dust. The functional unblinding -- oh, big surprise that most study participants could tell the difference between MDMA and a placebo -- was stuck in their heads as a serious problem.
I worked with government agencies and regulatory authorities in my career. I was disappointed but not shocked, and personally consider these actions as an exercise in moving the opportunity/profit to the "right" people.
Part of the issue here is that the adjunctive "therapy" - like psychotherapy piece - is vague and added in without much guidance. There's a lot of buzz-words that get thrown in but when you peel back the layers it ends up demonstrating very little in the way of a firm intervention.
Throwing psychedelics at widespread mental health issues can, and likely will, lead to unintended consequences when there aren't robust safeguards in place to ensure proper and effective use. Just because it seems like a good idea doesn't mean that it actually is. The worst thing I can envision is a system where we half-ass the roll out of psychedelic therapies leading to an uptick on the pharma side while the psychotherapy side languishes in uncertainty. Most clinical professionals I work with have very little understanding about how we should even interface with this stuff, and training existing therapists to use these models or even incorporate psychedelic integration, is pretty far from a given.
I don't think you're incorrect about "the right people" being a priority, but I also think that MAPS hasn't been doing the best job leading the charge in many ways. Further, the move from a Public Benefit corporation as it initially was modeled, into a purely for-profit group in Lykos has been deeply troubling to me.
From
an article in Vox in June:
Regulators also weren’t sure if MDMA would harm the liver or cardiovascular system in the long term because Lykos didn’t gather evidence for long enough to know. And we don’t know about the drug’s addictive potential because Lykos failed to report on addiction-driving effects like euphoria; worse,
some claim that Lykos pressured participants not to mention bad outcomes.
Regarding the lack of clarity in how therapy actually fit into all of this:
But there was another major question looming over Lykos (previously known as MAPS public benefit corporation, the
biggest force pushing psychedelics toward legalization over the past few decades). It’s a question that had begun to
bubble up in the news and which finally burst out at the FDA hearing: What the hell is going on with the “therapy” part of Lykos’s “MDMA therapy”?
“The drugs have been manipulated many times across studies, but the studies have not manipulated the therapy component at all,” Aday said. “That’s problematic. This is considered a combined drug-therapy treatment, and so far we’ve only evaluated 50 percent of that equation.”
Some types of therapy, like
cognitive behavioral therapy, have plenty of evidence to back up their effectiveness when used on their own. Others, not so much. Lykos favors certain therapy modalities that have less of an evidence base and more of a New Age flavor. Some prominent critics have said Lykos’s approach leads to foreseeable harms for patients, to the point that they argue Lykos qualifies as a “therapy cult.”
In one of the most fucked up examples of 'drinking the kool-aid' I've seen mentioned:
In one case, therapist Veronika Gold touched a patient, Annie, who became distressed and physically struggled against her. Gold was not troubled.
She writes in a book on psychedelic therapy: “Annie began to add her voice, expressing anger and saying, ‘Go away! Get your fucking hands away from me!’ The words were clearly meant for her father and did not indicate that she wanted me to go away or stop. Because we had the agreement to use the specific safe word “enough” if she wanted me to stop the touch, there was no confusion in my mind about how to proceed. Over the course of the next several minutes, she pushed my hands with increasing vigor and force.”
This is deeply concerning and creates a self-protecting dynamic in the therapist's mind where the only way to frame difficulties is to place the blame solely on the patient, excuse any missteps by the clinician, and treats someone who is dealing with significant distress as both the only person who can and should know what the rules are, and also like a child who doesn't know what's better for them.
I've met Doblin before, I've heard him speak, and I've seen the way he disregards legitimate critique while feeding his own self-righteousness in the pursuit of having the last word. He has followed closely in the footsteps of his psychedelic predecessors in a way that is incredibly dangerous while also standing to make an enormous payday had MDMA or 'midofetamine' (clearly branded to move away from the sinister sounding methamphetamine part of MDMA's name and also ridiculous to try and say with a straight face) been given approval. These drugs may increase positive change, and they can very easily increase the risk of severely traumatic responses in the one place that someone's supposed to be safe.
In a rambling e-mail sent out to people on MAPS's email list last week, Doblin made a very unclear appeal to the masses to view this decision as unjust and a slap in the face to the smart people in the room against a tyrannical federal agency. I have plenty of issues with the federal government and the persecution of drug users who have found real benefits from drugs like MDMA, but I have even more problems with people who chose to exploit these drugs while silencing the very reasonable dissent or critique that comes along in the process.
I know that MAPS is well connected here, and I do not want to minimize the good work that has been done over the years - I also don't feel like it's responsible to ignore the way in which this potential cash windfall has likely corrupted some folks involved in this process from the get-go. I am a therapist who works with patients who struggle with chronic mental health issues and addiction every day. I see the way in which systems have let them down, and the ways in which pharmaceuticals have made their lives objectively worse, all while regular folks end up having very little say in the process. In the end, this whole thing has shown to me what the true priorities of some members of the psychedelic vanguard have grown to become. They've exploited traditional spiritual practices under the auspices of healing, while silencing traditional practitioners and legitimate criticisms all along. It's all very obvious to me and I hope that this gives us all a moment of pause before we put people like Doblin on pedestals.
www.nbcnews.com
omdat ze 5-MAPB gebruikten, van een bekende NLs vendor btw.
