MDMA. Most lay people have heard of it but by names like Ecstacy or Molly and not in connection to treating PTSD or trauma. The scene that may come to mind when the words Ecstacy or Molly roll out in a tete-a-tete is the party drug at raves that make one feel all warm and cozy with strangers dirty dancing in a too small, too loud dark room. The warm and cozy part is right if not the purity of the street drugs.
Yet in another hashtag day – May 4, 2021 – in a world of evolving viewpoints MDMA is the point of conversation, again, as it finds its way from the dancefloor to page A12 of the New York Times.
This is not coming out of the blue. But it is a big deal.
“Who would have thought that MDMA could beat cannabis as the first federally illegal substance to become a prescription medication in the new decade?”
According to Brad Burge, director of strategic communications for the Multidisciplinary Association for Psychedelic Studies (MAPS) MDMA is set to receive FDA approval before weed.
“Burge admits his prediction might seem “surprising and counter-intuitive” given that no states have legalized MDMA as of yet. But the cannabis movement’s progress in individual jurisdictions has yet to translate as success on the federal level, where cannabis research is lagging behind studies of psychedelics.”
In that spirit we come to the May 4 article in The New York Times. In a newsletter press release from The Multidisciplinary Association of Psychedelic Studies subscribers received this exciting news:
“In today’s edition of The New York Times newspaper on page A12, the world-renowned publication reveals research results from the first Phase 3 clinical trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD).”
This hashtag moment is the result of the unwavering dedication of the humans behind the scenes at Multidisciplinary Association of Psychedelic Studies (MAPS), the organization that sponsored the study, and MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS that conducted the study.
“MAPS PBC develops and delivers therapy training programs and is responsible for the development of MDMA as a medicine. MAPS PBC CEO Amy Emerson describes its mandate: “MAPS Public Benefit Corporation is establishing a new paradigm in drug research, development, and commercialization in which we center our efforts wholly on the beneficiaries of our healing modality rather than shareholders.”
Ecstacy may do just that – when paired with talk therapy it was shown that it brought relief to those suffering from severe PTSD.
“It’s not the drug — it’s the therapy enhanced by the drug,” said Rick Doblin, senior author of the study and director of the Multidisciplinary Association for Psychedelic Studies, a nonprofit research group that sponsored and financed the clinical trials.
“Of the 90 people who took part in the new study, which is expected to be published later this month in Nature Medicine, those who received MDMA during therapy experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two months after treatment, 67 percent of participants in the MDMA group no longer qualified for a diagnosis of PTSD, compared with 32 percent in the placebo group.”
The study included people from a variety of trauma induced backgrounds with an average duration of 14 years: “PTSD caused by combat-related events; accidents; abuse; and sexual harm; 84% have a history of developmental trauma”.
“The first Phase 3 trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD) replicated and expanded on Phase 2 results indicating MDMA-assisted therapy may be an effective and cost-saving treatment for PTSD resulting from any cause.”
There is one more step before MDMA-assisted therapy gets FDA approval for therapeutic use: a second positive Phase 3 trial. “One is currently underway with 100 participants and approval can come as early as 2023”.
For the process to work a participant must be ready to deal with their trauma. Participants undertook preparatory sessions with two trained therapists and in following sessions spaced at set intervals – 3 sessions of 8 hours each spaced a month apart – they received either an inactive placebo or the MDMA. Neither the therapist or the participants knew which they were getting until after the participants took it – most who got the MDMA guessed correctly.
“While most participants correctly guessed whether they received a placebo or MDMA, this did not undermine the study’s results or its methodology, which was agreed to in advance by the F.D.A.”
How does MDMA help promote this self-healing?
Anyone who has done Ecstasy is familiar with those warm fuzzy feelings of “empathy, trust, and compassion” making it an attractive drug for intimate encounters – a result of elevated levels of oxytocin and dopamine. That is not the only effect of this unusual drug.
“The substance binds to proteins that regulate serotonin, a neurotransmitter that can, among other things, lift mood. Antidepressant medications like Prozac bind to these same proteins and block their reabsorption of serotonin, but MDMA takes this process further, causing the proteins to pump serotonin into synapses, strengthening their chemical signal.”
“But its primary therapeutic effect may come from its seeming ability to reopen what neuroscientists refer to as a “critical period,” the window during childhood when the brain has the superior ability to make new memories and store them. Evidence from a mouse study published in Nature in 2019 indicates that MDMA may return the adult brain to this earlier state of malleability.”
I would be remiss not to pay tribute to an important stakeholder behind the scenes in this journey to FDA approval and that is MAPS’ pro-bono pharmaceutical lawyer, Peter Barton Hutt of Covington & Burling LLP. The process of getting a drug approved is not an easy one and I suspect trying to get a Schedule I drug approved is all the more difficult. A lawyer who knows the ins and outs of the FDA and is dedicated to the mission is of vital importance.
“There are different ways of calculating how likely the Food and Drug Administration (FDA) is to approve a new drug, but one thing is for sure: Getting a medication from the early “this looks like it could be interesting” stage into clinical trials is a difficult process — and one that, more often than not, ends in failure.”
Who is the lawyer who will help lead the world into the 21st century ‘Age of Aquarius’?
Peter Barton Hutt has been a lawyer longer than many people reading this article have been alive. He joined Covington in 1960 and with the exception of four years has been with the firm in the Washington D.C. office where he is senior counsel. Those four years from 1971 to 1975 (might I add this writer was in college those exact years) he was not off the grid rather he was busy transforming the FDA as Chief Counsel. The legislation he drafted and changes he enacted remain intact to this day.
“He promulgated regulations to implement the review of GRAS food ingredients, require nutrition labeling for half the food supply, to define “imitation” food, to establish the emergency permit controls for low acid canned food, and to modernize food standards; to implement the prescription drug requirements of the Drug Amendments of 1962 following a sweeping victory in four Supreme Court cases and to create the OTC Drug Review for nonprescription drugs; to create a process for reevaluating the safety and effectiveness of all biological products that had been licensed since 1902; to rationalize the application of the Delaney Anticancer Clause to animal drugs; to require ingredient labeling for cosmetics and premarket safety substantiation for all cosmetic ingredients; and to prepare FDA for enactment of the Medical Device Amendments of 1976. He created the requirement of preambles for all proposed and final FDA regulations, initiated the use of guidelines (later named guidance) to establish informal FDA policy, and established the use of regulatory letters (later named warning letters) as an inexpensive and efficient enforcement approach. Just before leaving FDA, he wrote the comprehensive proposed procedural regulations that govern all FDA administrative action to this day.”
His accomplishments do not stop there. In his ‘spare’ time Hutt currently serves on the board of several publicly and privately held biotech companies and has spent the past 20 years teaching a course at Harvard on Food and Drug Law.
“Besides teaching a stellar course, he has inspired people to write papers that get published that change the future,” said HLS Dean Martha Minow.
As life has its coincidences (though Ram Dass always said there are no accidents) Allison Margolin, the founder of this very magazine https://darkmattersmag.com/ was a student of Hutt’s at Harvard Law. She wrote a paper as a 3L in 2002 entitled “On the Right to Get High” that was supervised by Hutt and posted online. It’s most germane to the legalization of these psychedelic medicines today. https://dash.harvard.edu/handle/1/8889470
“This paper argues that the criminalization of drugs, via the criteria the FDA [Food and Drug Administration] uses to put drugs into different schedules, is illegitimate on scientific and philosophical grounds”.
Additionally, Hutt has “represented the national trade associations for the food, prescription drug, nonprescription drug, dietary supplement, and cosmetic industries”.
It has been said of Hutt by Theodore Ruger a former student ‘95 and professor at the University of Pennsylvania Law School:
“With his many jobs—as teacher, scholar, private practitioner, and government lawyer—Hutt can be compared to a marathon juggler, Ruger joked—a person who juggles while running 26.2 miles”.
Hutt has a history of pro bono, humanitarianism, and is a trailblazer for change. In the 1960s he litigated pro bono cases on behalf of homeless alcoholics and drug addicts. He co-argued the only alcoholism case ever heard by the United States Supreme Court, Powell v Texas https://supreme.justia.com/cases/federal/us/392/514/. https://www.lexisnexis.com/community/casebrief/p/casebrief-powell-v-texas
After the Supreme Court case Hutt then “drafted the legislation that created the National Institute of Alcohol Abuse and Alcoholism and the National Institute of Drug Abuse. Based on this work, two-thirds of the States have repealed their statutes that had made public intoxication a criminal offense”.
MAPS is lucky to have Peter Barton Hutt, rightly named by The Washingtonian magazine one of Washington’s 50 best lawyers out of 40,000, behind the scenes moving MDMA and other psychedelic substances into their rightful place from the shadows of illegality to the “lightness of wellbeing”. https://www.cov.com/en/professionals/h/peter-hutt
In a big congratulations to all the stakeholders – the world looks forward to changing perceptions and the law from “MDMA presently defined as having “no medical benefit” and, therefore, not currently accessible as a potential treatment for PTSD or other conditions except as administered in clinical trials” to a legal and approved prescription medication.
Author: Sherri Margolin (Dark Matters)