Dear Friends,In the early 1980s, as a clinical psychologist, I had a remarkable experience as a patient of Dr. Robert Cantor, the founder of the Pacific Graduate School of Psychology. He legally administered MDMA to me over a period of a year and a half, and the benefits were profound. My heart opened, my empathy increased, and my defenses lowered. At the time, therapists across the United States were reporting amazing results using MDMA with couples, claiming they achieved more progress in a few sessions than in years of traditional therapy.However, in 1985, amid growing concerns about recreational use – as well as misinformation about its neurotoxicity – the Drug Enforcement Administration (DEA) emergency scheduled MDMA as a Schedule I substance, effectively banning its use for any purpose, including medical research.Around that time, Dr. Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), went before the government to seek approval for MDMA's medicinal use. Despite promising early research, the FDA rejected his proposal. Now, 39 years later, MAPS and its spinoff Lykos Therapeutics are still fighting for approval, only to face a significant setback this week. An FDA governmental advisory committee voted 10-1 in favor of advising against recommending that MDMA be approved as medicine by the FDA in its upcoming August meeting. This decision comes after decades of rigorous clinical trials that have demonstrated MDMA's potential as a catalyst for psychotherapy in treating post-traumatic stress disorder (PTSD) and other mental health conditions. There is still a remote chance that the FDA will vote against its own advisors.The government's main reason for this denial is that current MDMA studies fail to meet the gold standard of medical testing: the double-blind study. In this design, neither the administrators nor the patients know if they are receiving the actual medicine or a placebo. The FDA argues that a high percentage of subjects quickly determine whether they are in the placebo or experimental group based on the powerful effects of MDMA, compromising the study design.However, this reasoning is flawed. While the double-blind issue is valid, it should not be grounds for disqualification, especially when the medicine is demonstrably effective in approximately 80% of cases. The core question should be whether the positive effects are due to the medicine itself or a placebo effect enhanced by patients' awareness that they have received the active drug. In my view, this distinction is less important than the fact that patients are experiencing real benefits. If both the medicine and placebo effects are contributing to positive outcomes, that should be celebrated, not penalized.The government's position appears to be clouded by the emotional stigma surrounding MDMA as a "party drug," despite the fact that many substances have both therapeutic and recreational applications. This bias should not prevent MDMA from being used as a powerful catalyst in a professional therapeutic context, where it could potentially help hundreds of thousands, if not millions, of people.Ultimately, the government's role should be to prioritize the wellbeing of its citizens and support interventions that can provide the greatest benefit to the most people. Allowing emotion and politics to override scientific evidence and real-world therapeutic outcomes is a disservice to public health.The fight for MDMA therapy is not over, but the struggle has already spanned four decades. It is time for the government to adopt a more nuanced, compassionate approach and allow this promising treatment to become accessible to those who desperately need it. Golden light,Dr. Richard Louis MillerShow Notes* Patients with terminal illnesses often face debilitating anxiety, depression, and existential distress* Psilocybin therapy has shown remarkable potential to alleviate end-of-life suffering in clinical trials* "Right to Try" laws in over 40 states allow access to experimental drugs for the terminally ill, but the DEA is blocking access to psilocybin* Dr. Sunil Aggarwal, a Seattle palliative care physician, is fighting a landmark legal case to win psilocybin access for his dying patients* Some patients resort to underground psychedelics out of desperation; clinical psilocybin therapy would be far safer and more beneficial* The case pits the DEA's scheduling of psilocybin against state laws and patient autonomy at the end of life* Eight states and D.C. have filed amicus briefs supporting Dr. Aggarwal's case, arguing the DEA has overstepped* A summer decision from the Ninth Circuit Court of Appeals could be a pivotal moment for psychedelic medicine* The case highlights the need for a more compassionate, integrated approach to end-of-life care that addresses spiritual and existential dimensions* Responsible, mindful use of psychedelics may help change both how we live and how we approach deathSubscribe for ...
