Juliet, when we made love, you used to cry
You said “I love you like the stars above, I'll love you 'til I die”
There's a place for us, you know the movie song
When you gonna realize it was just that the time was wrong? Juliet
- “Romeo & Juliet”, Dire Straits, Making Movies (1980), Vertigo Records
There was a simmering debate in the mental health community over the potential benefits and risks of an impending "Psychedelic Renaissance." Now, the heat is turned up high. As the early stages of what could be a transformative era in healthcare begin to unfold, the narrative has become quite dramatic. Indeed, it has the intensity of a Shakespearean tragedy, with the so-called Love Drug, MDMA, sharing center stage. It's this production's Juliet. Following an intense setback on the path to acceptance, where fatal flaws were exposed, many are left questioning whether the timing for something new might just be wrong.
MDMA is the first psychedelic drug with the potential of coming to market in the United States and is due to receive a thumbs up or a thumbs down from the U.S. Food & Drugs Administration (FDA) by August 11, 2024. If MDMA—used in association with psychotherapy for treating post-traumatic stress disorder (PTSD)— is approved by the FDA, the next step would be for the U.S. Drug Enforcement Agency (DEA) to reschedule the drug. This would mark an unprecedented and pivotal shift in drug policy, as MDMA would then become the first psychoactive drug ever to be reclassified, highlighting its therapeutic potential and opening new avenues for mental health treatment using this and other psychedelics.
For supporters of MDMA, who envision a world where the drug can be used safely and without legal repercussions, the wait for positive regulatory outcomes has been exceedingly long. Lingering stigmas about psychedelics and legitimate safety concerns are not, however, MDMA's only adversaries. FDA approval and DEA rescheduling would also pose a significant threat to the established mental health drug market. The global daily-use antidepressant market was valued at $16.4 billion in 2023 and is projected to reach nearly $25 billion by 2031 (SNS Insider).
The pharmaceutical lobby is one of the most powerful and well-funded lobbying groups in the United States. In 2024, the pharmaceutical and health products industry spent approximately $107 million on lobbying in just the first quarter alone. This industry consistently ranks at or near the top of all lobbying spenders in the US, reflecting its significant influence on policy and regulation (Politico). None of the Top 10 health care lobbying spenders in the first quarter of 2024 were psychedelic development brands.
"What makes it so interesting and compelling is that when this treatment works, it tends to work quickly. We're talking about a treatment that is administered once to just a handful of times, which has very few precedents when it comes to the kinds of conventional treatments that you see in psychiatry or psychology." Dr. Sandeep Nayak, Center for Psychedelic & Consciousness Research at Johns Hopkins University.
Pharmaceutical companies rely on medications like antidepressants to sustain a recurring revenue model. Psychedelics that work quickly and effectively, however, do not fit this model as they may not require daily use (and they may not even require further use after the first dose). Microdosing of psychedelics is still being researched and may one day fit the daily-use model.
Few mental health professionals or researchers expect psychedelics to replace conventional treatments. Dr. Michiel van Elk, Associate Professor at the unit Cognitive Psychology of the Institute of Psychology, at Leiden University, says, "In the end, psychedelics might find their niche in mental health care, but always as part and parcel of a bigger toolkit of interventions that we can throw at people to help them and cure them."
Until they're sure how to monetize these emerging therapies, however, big pharma may be less than enthusiastic about losing market share.
This modern medical drama, true to Shakespearean form, encompasses elements of passionate love, the inevitable 'unblinding' of hidden truths (Adam & Eve would approve), betrayal, and the sometimes tragic consequences that emerge from these deeply-rooted classic conflicts.
On June 4, 2024, a group of experts met—in-person and virtually—at the behest of the FDA. This was the Psychopharmacologic Drugs Advisory Committee (PDAC) and they were assembled to discuss Lykos Therapeutics' New Drug Application (NDA) 215455, for midomafetamine (5-methoxy-3,4-methylenedioxyamphetamine or MDMA). After a series of presentations, in-depth discussions, and moving public comments, the committee would be asked to give their recommendations concerning the following two questions:
*Do the available data show that the drug is effective in patients with PTSD?
*Do the benefits of midomafetamine with FDA's proposed risk evaluation and mitigation strategy (REMS) outweigh its risks for the treatment of patients with PTSD?
Just a note, everyone knew coming into this meeting that, whether the committee supported or opposed approval of midomafetamine and Lycos' accompanying psychotherapy, the FDA was not obligated to follow their recommendation.
Quick MDMA History
MDMA has been around since 1912 when it was first synthesized by the pharmaceutical company, Merck. Having mostly disappeared since being tested by the US military as part of chemical warfare research in the 50's and 60's, it was synthesized again and introduced into psychotherapy in the 1970's by Alexander Shulgin.
MDMA then emerges from the San Francisco Bay Area not long after the Summer of Love when counterculture ideologies, free love, and the spirit of psychedelic experimentation helped supercharge what was (is) commonly called, Ecstasy, a street name for MDMA that is sometimes a less pure and occasionally less safe version of the drug.
The story of this potentially groundbreaking psychedelic treatment for various forms of mental illness, now under federal regulatory scrutiny, begins its current trajectory in the 1980s. This is when we meet Rick Doblin who first becomes smitten with MDMA, the substance that will be his co-protagonist in a lifelong drama.
Stay tuned for Act II
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