Dear MAPS community and supporters,
On September 6th, the Reagan Udall Foundation hosted a public meeting on advancing treatments for PTSD, where psychedelic therapies were a significant part of the discussion.
Following the meeting, the Multidisciplinary Association for Psychedelic Studies (MAPS) submitted the following comment to the Reagan Udall Foundation.
To whom it may concern,
On behalf of the Multidisciplinary Association for Psychedelic Studies (MAPS), we commend the Reagan-Udall Foundation for convening an essential conversation to advance treatment options for posttraumatic stress disorder (PTSD). PTSD has serious impacts on the individual living with it, their family and friends, and society at large. Current treatment options fall short, and when under- or untreated, PTSD can become life-threatening due to the intensely debilitating nature of the symptoms leading to a high prevalence of suicidality among sufferers. Fortunately, tested tools can help address the growing and pervasive crisis: psychedelic-assisted therapies.
Starting in the 1970s, MDMA was used by therapists to treat a variety of mental health conditions. An estimated 500,000 legal MDMA-assisted therapy sessions occurred before MDMA was criminalized. Despite a DEA Administrative Judge recommending MDMA be placed in Schedule III because existing evidence showed MDMA has a low potential for abuse, an accepted medical use, and accepted safety under medical supervision, in 1985, the then-Administrator of the DEA erroneously placed MDMA in Schedule I. This unilateral decision has had many devastating consequences, not least that it created obstacles to research and halted legal treatment for those suffering.
Beyond the evidence gathered before 1985 pointing to MDMA’s ability to be used safely and effectively, decades of clinical research have continued to provide mounting evidence. The recent Phase III studies sponsored by Lykos Therapeutics show that MDMA-assisted therapy has profound potential in addressing the unmet need for treating PTSD.
Psychedelics are distinct from many drugs that go through the FDA’s drug development process in that there is a vast body of non-clinical evidence further supporting their safety profile. Despite the criminalization of MDMA and other psychedelics, they have continued to be used by therapists in unregulated treatments for a variety of conditions, including PTSD, and millions of Americans use psychedelics every year outside of medical contexts. The scientific literature addresses blinding, expectation bias, adverse events, and more in the study of other psychoactive pharmaceuticals or therapy modalities.
Psychedelic-assisted therapies pose a few unique research and treatment questions worth discussing. The combination of a drug and therapy is “an innovative approach that was ill-suited for FDA review,” wrote the former Director of the National Institutes of Mental Health, “ but which might be a path to optimal care.” Within the therapeutic modality, aside from the administration of a powerful psychoactive drug, the only truly uncommon thing about MDMA-assisted therapy for PTSD is that it includes eight-hour sessions.
This raises questions about the role of the therapy versus the role of the drug in improving symptoms, where several data points can inform an analysis without subjecting people living with PTSD to a trial in which they receive only the drug and no therapy, an ethically questionable approach. For example, a data analysis comparing the MDMA-assisted therapy placebo group in the Lykos trials would likely demonstrate that the inner-directed therapy alone generates better responses than current front-line treatments (with significantly lower drop-out rates). However, efficacy comparison to currently available treatments is not typically a factor in FDA evaluation.
Another stems from providing therapists the opportunity to experience the treatment in a therapeutic context. No responsible researcher would suggest that prescribers of SSRIs should have the opportunity to try them in a clinical trial. It is extremely common, though, for therapists in training for a new modality to receive the treatment themselves. Because psychedelics generally produce only short-term physiological changes and are delivered in a limited number of dosing sessions, we should not compare therapist self-experience to typical psychoactive pharmaceuticals, but rather to a typical therapy training program.
These research questions should not preclude these treatment options from being available to the millions of people suffering from a lack of adequate care for a life-threatening condition when more than half a century of evidence demonstrated these therapies can be utilized safely and effectively.
We urge the Reagan-Udall Foundation, in its unique position, to implement strategies to accelerate research and FDA approval of psychedelic-assisted therapies:
- Support the FDA in simplifying Expanded Access programs to obtain real-world evidence for drugs that have been cleared for Phase 3 studies,
- Support efforts to ensure Right to Try legislation applies to controlled substances under investigation,
- Convene an expert and stakeholder panel to establish and recommend a modernized approach to evaluating drug-therapy combinations, and
- Create an evidence accelerator, similar to that for COVID-19, as a forum for stakeholders across the healthcare spectrum to share real-world data and generate ideas to make psychedelic-assisted therapies rapidly available, equitable, and safe within the healthcare system.
Sincerely,
Rick Doblin, PhD; Founder & President
Betty Aldworth; Director of Education