MDMA Approval Process: A Setback and a Set-Up for a Comeback?
The recent advisory committee meeting regarding MDMA-assisted psychotherapy for PTSD may represent a humbling setback for the psychedelic research field and organizations like MAPS/Lykos. It suggests the fragility of progress made over nearly four decades of arduous work within the bureaucratic regulatory system. The challenge posed by the 10-1 no vote against approving MDMA-assisted psychotherapy for PTSD, while seemingly a set-up for failure by the misinformed as well as opponents to MAPS/Lykos in the medical field and psychedelic space, may be a set-up for a massive comeback that will lead to better implementation of a new paradigm of mental health care.
Several key issues emerged during the meeting that can be addressed to facilitate the approval process:
1) Blinding and study design concerns were raised, despite the rationale behind the utilized design being well-established (Doblin, 2002) and previously agreed upon through the FDA's special protocol assessment process. Effective blinding remains an inherent challenge for psychedelic therapy trials (Bershad et al., 2016), and this ought not to be a reason to not approve this medicine.
2) Allegations of potential bias influencing the large effect sizes were made without substantive evidence. An analysis examining outcomes based on prior MDMA exposure may address this (Yazar-Klosinski & Mithoefer, 2017). Furthermore, the large effect sizes are too significant to be explained only by bias or by expectancy effects.
3) Conflation between the therapeutic intervention and investigational drug confused the committee, given their lack of expertise assessing psychotherapeutic modalities (Duvivier et al., 2019). Looking at the past approval process of Buprenorphine (Suboxone) with a behavioral health component may help address this. ?
4) Requests for additional subgroup analyses overlooked Lykos' efforts to ensure adequate representation of underrepresented groups (Michaels et al., 2018). This was in fact adequately addressed in the second Phase III clinical trial.
5) While safety concerns are legitimate, MDMA's physiological risk profile is well-characterized (Vizeli & Liechti, 2017). Potential psychological risks require appropriate mitigations akin to standard therapeutic practices. There are far higher physiological and psychological risks with psychiatric medications currently in widespread use.
The coordinated efforts by undisclosed affiliates providing negatively slanted public comments raise ethical concerns regarding transparency.
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Addressing these issues through comprehensive data analysis and clarification is crucial for an evidence-based regulatory decision by August 2024. The field must persist through such setbacks as this pivotal treatment reaches the culmination of decades-long efforts.
References:
Bershad, A.K., et al. (2016). Psychoactive Drugs & Psychedelics. Annu Rev Psychol, 67, 499-523.
Doblin, R. (2002). A Clinical Plan for MDMA (Ecstasy) in the Treatment of Post-Traumatic Stress Disorder. J.Psychoactive Drugs, 34(2),185-94.
Duvivier, H., et al. (2019). The psychedelic renaissance and the limitations of a limited renaissance. Front Psychol, 10, 1770.?
Michaels, T., et al. (2018). Inclusion of people of color in psychedelic-assisted psychotherapy. BMC Med, 16, 96.
Vizeli, P. & Liechti, M. (2017). Safety considerations of pharmacological study participants. Curr Top Behav Neurosci, 36, 491-522.
Yazar-Klosinski, B. & Mithoefer, M. (2017). Potential Psychiatric Complications in Psychedelic Research. Ther Adv Psychopharmacol, 7(2), 36-49.
Clinical Psychologist ? Digital Mental Health ? Tourism-Psychology ? Awe Research in Nature, Well-Being, Environmentalism, Psychedelics, & Gaming ? Visitor & User Experience ? Anxiety & Metacognitive Research
5 个月Fortunately, other countries are moving forward and paving the way. This will hopefully bring further research and efficacy data??, and more importantly, access to psychedelic treatment to those who current available treatments aren't providing benefit..
Thanks for writing this. I also think medical devices are a fair parallel for your third bullet point. They tend to require specialized training of the doctors who use them due to their uniqueness in the field and they typically have a procedure that goes along with the implementation of them. Very similar qualities to MDMA-AT in these ways.
Co-President / Clinic Director - MSW, LCSW, LCADC, CCS, ICCS, CPATP, MINT Member
5 个月The weaponized FDA. Not supprized as big Pharma cannot figure out how to take ownership of it and make billions on it yet. But they will approve diete drugs that have known possible adverse side effects including death. Just listen to all the possible side effects of most of the drugs they approved already some of which have been recalled and millions have been paid out in law suits. Unfortunately, paying out a few million when you made billions is in big pharma game plan. Sorry if i sound like a conspiracy theorist but not much passes the smell test anymore. Just look up how many directors of the FDA end up in very high positions in major pharmaceutical companies and you will see soms very disturbing stats that are tat amount to payoffs for playing the game.
Psychedelic educator, harm reduction and integration coach, certified mindfulness teacher.
5 个月Was honestly thinking today—with all the discourse that’s arisen since the committee meeting—that it’s going to pass in August.
Welder
5 个月My question is now with this set back is what is the medical psychedelic community going to go do now moving forward? Something needs to break through here; pharmaceuticals do not do anything great for depression, anxiety and ptsd. But, I think experts in the field already know that; it is more complex than a mere chemical imbalance and that is why a third of the population are labeled as treatment resistant. I hope state and federal agencies wake up and actually actively do something to benefit the mental health of our society.