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.

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