Summary: Wall Street Journal Magazine publishes a detailed review of MAPS’ ongoing clinical research into MDMA-assisted psychotherapy’s effectiveness at treating PTSD and trauma. The magazine covers results from Phase 2 clinical trials, upcoming Phase 3 studies, the FDA’s recent decision to grant MDMA a Breakthrough Therapy Designation, and MAPS Public Benefit Corporation which will regenerate revenue for ongoing psychedelic and marijuana research once MDMA-assisted psychotherapy is a legal prescription medicine. Josh Dean speaks with MAPS Founder Rick Doblin, Ph.D., about the timeline for legalization which he predicts should be approved by 2021. “By that time, he will have spent 35 years and $60 million in donations on the legalization effort,” explains Dean.
Originally appearing here.
"As the director of addiction psychiatry at NYU Langone Medical Center, Stephen Ross spends most of his time helping people quit drugs. But early next year, he will begin administering MDMA in his ‘dosing room,’ a chamber in Dr. Ross’s medical research lab that resembles a comfortable living room, with a gong on the wall and ceramic mushrooms decorating the shelves. After ingesting a 125-milligram capsule of the drug, a patient will recline on a brown felt couch as Dr. Ross and a co-therapist conduct an eight-hour talk-therapy session.
MDMA, aka ecstasy, will still be an illegal drug when Dr. Ross begins these sessions. But it’s emerging as one of the most promising treatments for intractable post-traumatic stress disorder. In Phase II clinical trials, which ended in November 2016, more than two-thirds of patients attained ‘sustained remission’ of their PTSD after three MDMA-assisted therapy sessions. Based on those results, the FDA approved plans for Phase III trials, which will be led by 80 licensed therapists around the country, including Dr. Ross.
In August, the agency went a step further, giving MDMA a Breakthrough Therapy Designation, which puts it on a fast track for review and potential approval. The coming Phase III trials are the last step in the drug’s long, quixotic journey to prescription medicine.
If MDMA is medically legalized, it will be more tightly controlled than most pharmaceutical drugs. Unlike opioids and medical marijuana, MDMA won’t be available at a pharmacy. No one will go home with a bottle of ecstacy pills, making resale impossible and reducing the possibility of abuse. The drug will be prescribed only as part of an inpatient therapy program and exclusively for the treatment of PTSD. About 8% of Americans—24.4 million people—suffer from the disorder, but that rate more than doubles for veterans."
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"According to Doblin, one group that stands to benefit from MDMA is America’s veterans. The Department of Veterans Affairs estimates that 30% of Vietnam vets suffered from PTSD, and the condition is even more prevalent in those who’ve fought in Iraq and Afghanistan. By Doblin’s estimates, the VA spends $17 billion a year on disability payments for veterans with PTSD, payments that go on indefinitely when the condition doesn’t improve.
Doblin has met with the secretary of the Navy, an assistant secretary of defense and two executive directors at the VA. He found receptive audiences but was unable to persuade the VA or Department of Defense to fund research. (The VA and Pentagon both declined to comment for this article.)
Veterans are free to participate in trials on their own, and they will be a priority of the Phase III studies. Though no VA hospital will officially direct patients to MAPS, therapists affiliated with those hospitals may do so, and Doblin says many veterans are among the 18,000 who have volunteered for Phase III trials on the MAPS website.
Doblin predicts that MDMA will be approved by 2021. By that time, he will have spent 35 years and $60 million in donations on the legalization effort. He’s still fundraising for the Phase III trials, an effort which recently took him to Burning Man, the weeklong festival in the Nevada desert. But if MDMA is approved, MAPS can begin to generate revenue by manufacturing and distributing the drug to approved clinics. MDMA is an off-patent compound, meaning MAPS won’t get patent protection in exchange for its research investment. But in certain cases, the FDA grants five years of ‘data exclusivity’ to groups that identify and prove new indications for off-patent drugs. This will give MAPS a five-year monopoly on MDMA manufacturing in the U.S. before anyone else can produce generic versions of the drug.
The revenue from manufacturing MDMA could threaten MAPS’ nonprofit status, so Doblin spun off the clinical research division in 2014 into a public benefit corporation. As a B-Corp, it will pay taxes on income but favor social benefit over profit. Forming a B-Corp, Doblin says, ‘is another way to reassure regulators that if MDMA becomes a medicine, we’re not going to be like, "How do we roll it out as fast as we can?"’
If the drug is approved, the rollout will be limited by the number of DEA-certified clinics and licensed therapists who have been trained to conduct MDMA-assisted therapy. Doblin predicts that there will someday be thousands of these clinics, offering not just MDMA but also other psychedelics that were formerly banned substances."