MDMA: The Long, Arduous Journey to FDA Approval

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The Early Years

​Rick Doblin, Founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS), is credited with getting MDMA to the brink of FDA approval. He started MAPS in 1986 with the seemingly impossible goal of bringing mass mental health to the world using psychedelics. He gave it 50 years. With any luck, MAPS will see the legalization of their first psychedelic, MDMA, in 37. But the journey started way back before 1986 and had its roots in Southwest Florida.

At age 18, Rick began studies in 1971 at Sarasota-based New College. As a “child of the 70s”, Rick has acknowledged experimenting with various psychedelics, including LSD. For a young man of 18, it can be overwhelming and for Rick, LSD created an existential crisis, sending him to seek help from the school’s guidance counselor. That counselor was the beginning of several synchronicities as he gave him a book by Stan Grof, Associate Professor in Psychiatry at John Hopkins University, and an early researcher in LSD therapy. Rick became hooked. He wrote to Stan and was amazed when he responded, inviting him to a month-long workshop in California in the Summer of 1972.

That Fall he dropped out of college and didn’t return for 10 years, telling GQ in an article published 10/26/21, “The reason I took 10 years off is because I had done so much LSD and mescaline, in particular, and a little bit of psilocybin mushrooms, that I was really lost.” As fate would have it, just as Rick was set to continue his studies, Stan Grof interceded again. Stan was by now a Scholar-in-Residence at the Esalen Institute. Founded in 1962, Esalen’s goal was to explore human potential through, among other modalities, transpersonal psychology and altered states of consciousness. In the Summer of 1982, Rick won a coveted spot as an Esalen Work Scholar, working for Stan. And, yes, he dropped out of college again.

Enter MDMA (aka Ecstasy and Molly): during the 70s and early 80s, MDMA remained legal and millions of people took Ecstasy while clubbing. The Drug Enforcement Agency (DEA) was determined to put a halt to the loophole that allowed it to remain legal. Rick had lived through the criminalization of LSD and was determined to get in the front of the curve to stop the DEA from criminalizing MDMA. Through 1984, he fought the good fight, traveling to Washington, DC several times to try and stop them.

He ended up losing Round One to the DEA as they did criminalize MDMA in 1985 so he concluded that effecting policy change would be the only route to legalization. He set about to learn what he needed and returned to New College, finally graduating in 1987, 16 years after he started. He followed that with a PhD in Public Policy at Harvard’s Kennedy School of Government, completing his doctorate in 2001.

Along the way, he had a life-altering dream about the holocaust that told him he must do what he can to stop humankind from destroying itself and Rick believed psychedelics were the means. Although it was clear that he was blessed to have been born with the intelligence and determination to see him through the long, journey ahead, it was the dream that drove him with the fear that he must not fail. He launched MAPS in 1986 and worked hard from 1986 to 1990 when the DEA finally allowed research using psychedelics. There was cause for celebration as MAPS could finally begin clinical research using MDMA.

The FDA Years
It typically takes 15 years for a drug to receive FDA approval. Imagine the fight then to seek approval for an illegal drug. In the end, the process added more than 20 years to the timeline. One early roadblock is that, even though the DEA had finally allowed psychedelic research in 1990, it was not until 1999 that MAPS was able to propose a study using MDMA-assisted psychotherapy to treat PTSD. Barrier after barrier had been put up only to be knocked down by Rick and his equally determined colleagues at MAPS.

Yet another five years would pass before MAPS would start their Phase II Clinical Trial. Then it took 13 more years, during which time MAPS and several other research institutions conducted their own trials, before the FDA finally awarded MDMA a Breakthrough Therapy Designation. The Designation meant the FDA had agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD. So, there they were in 2017, more than 30 years since MAPS founding, clearing the hurdle to what may be considered the toughest part yet as they knew many companies spend years getting to this same point only to fail in the make-or-break Phase III Clinical Trials.

Finally, fast forward to May 2021 when the first of two required Phase III Clinical Trials demonstrated significant rates of eliminating PTSD symptoms in 90 subjects. After 2 months, 67% of participants receiving MDMA-assisted psychotherapy exhibited zero PTSD symptoms as compared to the 32% that had received a placebo with psychotherapy. The second Phase III Clinical Trial is now underway and is set to be wrapped up at the end of 2022. Although not guaranteed, there is every expectation that this second trial will also yield significant results and the FDA will approve MDMA in 2023, 37 years after MAPS was launched.

I know I wondered why MAPS chose MDMA out of all the psychedelics and why they focused on PTSD. The simple reason was that Rick had an experience with a friend who suffered from PTSD who had been helped by a combination of MDMA and talk therapy. Standard anti-depressant medications help PTSD sufferers only 20%-30% of the time which leaves millions of people suffering. Turns out, of all the psychedelics, MDMA is the sweet spot for opening those parts of the brain that can heal trauma. Although all psychedelics increase a sense of oneness and positive mood, MDMA, unlike the others, does not cause ego dissolution, increasing activity in the prefrontal cortex, that part of the brain that controls rational thought. At the same time, MDMA also quiets the amygdala, our fear center. This allows a “window of opportunity” to open, and a trained psychotherapist can guide the PTSD sufferer to confront and work through their trauma.
The Cycle Continues

Looking to 2023
FDA approval may be thought of as finishing a marathon, but only one with several more to go. After federal approval, each state must reschedule MDMA for use in a medical setting. Then there is the uphill battle to legalize psychedelic-assisted psychotherapy in the rest of the world. Additionally, MAPS’ mission has not changed. They still seek to bring mass mental health to the world and will not stop until all psychedelics are accessible and affordable for all. Rick clearly understands the multi-generational effort required to bring MAPS’ vision to reality saying, “Psychedelic-assisted psychotherapy research is more urgent than ever. This next generation’s passion and ability to be successful holds great promise, as does the growing disillusionment with the disastrous Drug War.”

This story does circle back to Southwest Florida. Another New College of Florida grad, Alexandra Mars, is also determined to take up the mantle and fight for legalization. As a child, Alex suffered from Crohn’s Disease and after years of failed treatments, turned to plant medicines for relief. As a result, her life’s mission is to educate people on the power they can elicit on collective and individual healing. But as fierce as Alex is about the need to build global consensus on the power of plant medicines, she is just as fierce about protecting our planet. Her senior thesis at New College of Florida was on the influence of psychedelics on human connectedness and their relationship to nature and the environment. Rick, committed as ever to walking the talk, was right there serving as one of her mentors.

If Alexandra is proved right, psychedelics will greatly impact our ability to protect the environment to ensure the survival of our planet. Joseph Campbell, the foremost scholar on myths, bemoaned the death of myths and the rituals associated with them as the source for humankind’s disconnectedness and inevitable destruction of our world. Way back in the early 1980s, Campbell had said that environmental activism may be the only way we reconnect and save our very existence. Hence, the cycle continues: from Joe, to Rick, to Alex. Rock on!


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