(When meeting Brad Burge several years ago, I was immediately struck by his masterful ability to communicate to all comers at an academic conference we were speaking at. He connected immediately, and never lost the purpose, message, or empathy that we all strive to have when speaking to people we care about, even when addressing someone he’d never met before. He’s become one of MAPS’ most effective ambassadors, overseeing a period of rapid visibility expansion, to the point where MDMA & PTSD is coming up at the watercooler and at the holiday dinner table. I wanted an update on the MDMA/PTSD clinical trial after my previous article on it, so I was overjoyed when he obliged! Enjoy the chat, and feel free to refer to it while talking about MDMA & PTSD with your family over the holidays!)
Photo courtesy of MAPS.
1. Even with the recent Breakthrough Therapy designation, how do you keep going in the Age of Trump?
We have been able to make a lot of progress since the election, including getting the FDA’s stamp of approval for Phase 3 trials and the Breakthrough Therapy Designation, which came in August. Trump has taken a fairly hands-off policy when it has come to the FDA so far and has given every indication that his administration supports facilitating accelerated development of pharmaceuticals and new medical treatments. Plus, and more importantly, we see psychedelic science and psychedelic therapy research as bipartisan issues, since they are not about being countercultural or revolutionary or being oppositional in the traditional sense, but rather about being careful scientists and treating serious mental health conditions. Of course we think that this research has tremendous transformational value, and that the approval of MDMA-assisted psychotherapy for PTSD is likely to change how our culture understands and treats mental illness, but we are working with the system to make those changes happen, not outside it. We have had equally positive media reports, for example, from The New York Times and Scientific American as from Fox News and Breitbart.
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:
- The drug treats a serious or life threatening disease or condition.
- 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.
In what is the biggest “I can’t believe we have to prove this academically” story of the year, three Johns Hopkins researchers showed that 66-92% of people who got a pile of prescription opioids, didn’t use them all. Not only did 67-92% of patients report unused opioids (92!) but up to 71% of opioids obtained even by surgical patients weren’t consumed. This review of 6 different studies drives home the need for much of the mainstream addiction/treatment community to modernize their thinking when it comes to harm reduction and human behavior. Unsurprisingly, 3 out of 4 people didn’t secure their opioids properly (yes, the FDA legitimately believes that people should store pain pills in locked containers). Even more unsurprisingly, no more than 9% of patients in any study “disposed” of their drugs “properly.” What does disposing drugs properly look like? This: