Why It’s So Important MDMA Has Been Designated a “Breakthrough Therapy” By the FDA

Report by Terry Gotham

At Burning Man 2006, at the Entheogen Camp on the Esplanade, I watched someone ask Shulgin how many times a year he thought it was safe to take MDMA. He said “do you really want to know?” The guy who asked the question wasn’t so sure, being confronted with the possibility of a real answer. On August 26th, 2017, the Multidisciplinary Association for Psychedelic Studies announced that the FDA had granted MDMA the Breakthrough Therapy Designation for its treatment of post-traumatic stress disorder. After decades of demonization, lies, bad science and straight up villainy by the powers that be, MDMA is being given its time to shine. This victory in a long road that MAPS & MDMA have traveled is a long time coming and absolutely pivotal. “Breakthrough Therapies” are seen as crucial, high-value drugs that the FDA wants to assist through development and review. To receive this designation, a drug must qualify in two ways:

  1. The drug treats a serious or life threatening disease or condition.
  2. Preliminary clinical evidence indicates the drug may demonstrate “substantial improvement over existing therapies” on “one of more clinically significant endpoints.”

This designation is a victory, but if you only know MDMA as something to take at parties, you might not know why. From its use as a legal alternative to alcohol in the club/house music scene in 80’s Chicago/Dallas/NYC to its current iteration as the much maligned “Molly,” MDMA has gotten a pretty bad rap over the years. To understand why this news is being celebrated in harm reduction, drug policy and legalization advocacy circles, we need to look back at how MDMA took hold of America & how it became illegal, because a lot of what you think you may know about its history is wrong. For example, most believe Alexander Shulgin invented the compound for the first time in 1965 for Dow Chemical, while it was actually first synthesized in 1912 by Anton Köllisch, a German chemist working for Merck. The chemist was studying substances to stop bleeding but without bumping into the patent held by Bayer for hydrastinine, so in a bit of 20th century novel psychopharmacology, they developed an analogue, methylhydrastinine. MDMA was actually only synthesized as an intermediate step in the methylhydrastinine synthesis process. One of the most important drugs of the 20th Century was created accidentally, just like Hofmann producing LSD accidentally 36 years later.

The lack of interest in MDMA continued until the substance was evaluated due to its similarity to adrenaline & ephedrine by Max Oberlin in 1927 & Albert van Schoor in 1952 to assess its similarity to amphetamine and other stimulants. In the early 50’s, the Army also conducted the first cardiovascular & toxicological tests on mescaline & 7 analogs, MDMA being among them, but we only learned about these studies in 1969 after they were declassified. When Shulgin re-synthesized the substance in 1965, he didn’t end up taking it  Interestingly, MDA had been in wide use during the late 60’s (eventually being scheduled in 1970), but MDMA was totally unknown. Around that time, it’s said that Shulgin sent instructions for MDMA synthesis to an entrepreneur in LA, who in turn sent them to a contact in the Midwest near Chicago. It’s hypothesized that this individual used this information to begin synthesizing MDMA in mass quantities, leading to its explosion in the Chicago house scene, as documented in an report published in The Journal of Criminal Law, Criminology & Police Science after being received in February 1971.


Shulgin was continually presented with positive anecdotal reports by friends, students & colleagues about the substance, so he re-re-synthesized it & consumed it for the first time in September 1976, with the first study documenting its effects in humans published by he & Dr. David Nichols in 1978. In Shulgin’s book PiHKAL, he describes MDMA as his “low-calorie martini.” He wasn’t personally impressed with the substance, but thought its effects could be applicable to the therapeutic process & development of the therapeutic alliance.  He introduced the substance to a man named Leo Zeff, a Jungian analyst who was already leading LSD-assisted therapy sessions in California. Zeff was so taken by the substance that he trained thousands of psychotherapists in MDMA-assisted psychotherapy. It was seen as an exceptional assistant to therapy, eliminating arbitrary resistance, increasing communication and feelings of empathy.  Dr. Zeff and others who used it referred to the drug as “Adam” instead of MDMA or any of the street names we’ve come to to refer to 3,4-Methylenedioxymethamphetamine by.

It doesn’t change ordinary perception very much, but changes the feeling tone, the feeling quality and reduces fear, thereby allowing you to look at, in a kind of impartial way, things that are normally just too anxiety provoking to look at.
~Ralph Metzner

Because the explosion & subsequent scheduling of LSD was still fresh in the minds of those prescribing & partying with MDMA, therapists, chemists and other miscellaneous psychonauts didn’t expand their consumption circles past small informal groups, totally devoid of the “Turn On, Tune In, Drop Out” marketing and ethos that so many had come in contact with a decade earlier. But of course, no one could keep a secret. By the early 1980’s Chicago, New York, Boston, Dallas & San Francisco had started drenching their dance parties with it. By the mid-80s you could get it on college campuses. This explosion in use (10k doses consumed in 1976, 500k doses consumed in total by the 1985 when it was scheduled, with another 2million more produced before it became illegal) can be traced to a few different networks, including Midwestern networks that moved thousands of pills in & out of Chicago, where the first MDMA pill was discovered by law enforcement in 1970, the Boston Group that started producing the MDMA for a small group of chemists & therapists in 1976 and continually refused to up their production, and the Texas Group, a much more enterprising group of chemists and marketers led by a Catholic priest named Michael Clegg.

Michael Clegg liked MDMA. He liked it a lot. So much that he, like a couple of other people in our story, stopped what he was doing and dedicated his life to getting this stuff out there, going so far as to say:

I had my whole life wanted to know the thoughts of God. When I had my first experience with Ecstasy, it was like Moses on the mountain… with the revelation. I think I had three callings in my life: one was to the priesthood, one was falling in love with my wife and to get married, and this was the third one. My mission was to get Ecstasy to the whole world.
~Michael Clegg, Ecstasy Rising (ABC News Documentary)

And that he did. For years, his group produced it in California & gave it away in Dallas. First to friends, then friends of friends, creating a massive pyramid, starting to charge only when it became “prohibitively expensive” (the words of Clegg himself). At his peak, he was producing 500,000 pills a month, with a pill-in-a-bottle being sold as “Sassyfras” at bars all across the Dallas-Fort Worth area, spreading to Austin soon after. MDMA eventually replaced MDA entirely as the “not pot, but not acid” wavy drug of choice for hippies, yuppies, college students, sexual minorities, psychonauts and “Fuck The Man” types of all kinds.

Like with everything else, by the time the early 80’s had rolled around, the party was over. After a press blitz and a year of planning and data collection, the DEA proposed scheduling MDMA on July 27th, 1984. And, just like every other time the DEA has done something awful and flagrantly unconstitutional, they were shocked by the push back they got.  What was new about this flavor of pushback, was that it involved non-broke people. People had gotten used to seeing hippies, burnouts, addicts and assholes demand drugs remain legal or be legalized in the aftermath of the Nixon administration. What people hadn’t gotten used to was doctors, psychiatrists, researchers and academics objecting to the decision to schedule MDMA. I’m not kidding, a DEA agent admitted in a Newsweek article they had “no idea” therapists were using it. Of course, this didn’t stop them from trying to get it scheduled, which created a lovely little Barbara Streisand effect for it, broadcasting the drug across mainstream media and exploding demand. With the Texas Group producing up to 8000 pills a day, it took an emergency scheduling measure at the behest of Senator Lloyd Bentsen to declare the drug Schedule I on May 31st, 1985. Get this, to justify the ban they used the neurotoxicity of MDA, not MDMA. But that’s not even the best part.


A bunch of those eggheads, therapists, and researchers actually ended up testifying that MDMA could be used medicinally. To the point where a judge recommended that the drug be classified as a Schedule III substance, like testosterone, buprenorphrine, vicodin and pentothal. The DEA didn’t give any fucks as usual, and classified the drug as Schedule I because of course they did. Lester Grinspoon, outspoken advocate for medical cannabis and MDMA-assisted therapy, sued the DEA and actually won. A judge shot down the DEA administrator’s justifications for labeling MDMA as Schedule I, but the court order was not binding. The DEA admin, who went by the name of John C. Lawn (in case you needed a new nemesis), just “reviewed the evidence” once again, and re-classifying it as Schedule I. Just like how the Secretary of the EPA doesn’t think climate change is real, John C. Lawn said the evidence 200+ cases of successful MDMA therapy brought to the discussion was worth anything. This led to MDMA being scheduled internationally, and of course, the market moving to synthesize waves of novel psychoactive substances and iterations on the illegal substance. More recently, a baggy of “Molly” (short for Molecular MDMA) that you “dip” into over the party, has replaced the pill as the defacto vehicle for consumption. And of course, it’s just as impure and adulterated. Only this time, as we’ve seen, the adulterants can be way, way wackier than what you might’ve gotten at a club in Dallas or an after-party in Chelsea. Methylone, Mephedrone, Flakka, and dozens of other novel psychoactive substances have come and gone, largely as a way for recreational users to pass the time until MDMA purity rises again, which it does, oscillating up and down over a series of years.

The thread through this decades-spanning odyssey, is that MDMA has never been acknowledged by the US government as a substance that could have medicinal properties and wasn’t a Schedule I drug, on the same level as methamphetamine, PCP and carfentanil. Until now. This week’s announcement is not only a vindication of activists that have worked for years to bring this substance above ground, but also to thousands of real-life therapists all around the world, doing MDMA therapy illegally, under threat of losing their license to practice if they’re discovered. MDMA can be used for so much more, but for the last 30 years it’s been demonized as something that puts holes in your brain (it doesn’t), makes you unable to feel happy (nope), and gets people to dance to shitty music (ok, they may have a point on that one).


Unlike LSD, MDMA never had a Timothy Leary. MDMA also never had a Charles Manson. Some might say Michael Alig could be a poster child for everything that was wrong with Club Kids, but by the time he was all about drug dealing and murder, he’d moved on to much harder drugs. Even the RAVE Act, signed by everyone’s favorite neo-liberal uncle who likes to give back rubs on camera, Joe Biden, was more focused on dealing of drugs in EDM environments. The demonization of ecstasy was a nice side benefit, but the outrage of kids dying of dehydration because of rolling too hard has faded. The kids are still dying though. This designation is the culmination of an epic journey Rick Doblin, MAPS and a legion of advocates, therapists, researchers dedicated to not just keeping any more kids from dying, but using the drug for much more important things than making Steve Aoki sound palatable for 4 hours. Veterans, police officers, EMTs, victims of violence and many others need this stuff. It’s way bigger than just making sure everyone on your art car is high as fuck for the Burn.

Oh, and Shulgin said the answer was four, if you were still wondering. Four times a year at maximum, spaced out, and without using too high of a dose, to ensure you don’t shock your serotonin system so hard you cause degradation. Just FYI.

3 comments on “Why It’s So Important MDMA Has Been Designated a “Breakthrough Therapy” By the FDA

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