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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Shockingly, People Don’t Actually Throw Out Drugs.

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:

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Water, Hyponatremia, MDMA & Heat Stroke: How Not to Die

 

By Terry Gotham

Now that the summer festival season is in full swing and we’ve all been dripping with sweat once at least once, it’s time to have a little chat. If you’re one of the people who hasn’t pissed clear at a festival since Dubya was president, this is 100% for you. If you’re the person in your circle that hounds everyone else to stay hydrated and eat salty snacks Wednesday morning on playa, this is also 100% for you. For this edition of Do No Harm, I spoke to Dr. Daniel E. Rusyniak, Professor of Emergency Medicine & Adjunct Professor of Pharmacology/Toxicology and Neurology at the IU School of Medicine. He dropped a pile of knowledge, so I’m going to be able to walk you through what happens to your body when you roll your face off. Down to the hormonal level, putting yourself at risk for heatstroke & hyponatremia. And of course, also illustrate how to NOT do that.

In your body, there’s this antidiuretic hormone called Vasopressin, also known as ADH. ADH’s job is to ensure your body retains water (hence it being known as an antidiuretic), and to constrict blood vessels. By increasing the water pemeability of the kidneys, it plays a key role in keeping your fool ass hydrated. When it’s heavily secreted, your kidneys get the signal to fast track water reabsorption & pissing yellow. This happens in a few complicated ways you can read about here. Guess what MDMA happens to affect?MDMA, along with many of the novel psychoactive substances taken at festivals, regional burns, and EDM shows can be grouped in the term “amphetamines and stimulants.” Which have the much desired effect of decreasing fatigue, especially fatigue you generate from exertion. You know, that thing you’re actively taking drugs to ignore?  Kind of like missing red flags on date 3 & 4, ignoring warning signs from your cardiovascular systems can have disastrous effects on your health.

Fatigue is crucial in preventing heat stroke. The reason this signal is being sent, is to keep your temperature from spiking too high. The thing that everyone forgets about amphetamine use is that it doesn’t actually give you super powers. The fact that you’re getting tired more quickly in hot environments is a warning/break point signal to your body/mind that you’re being fatigued.  When sober, mammals reach a point of exertional fatigue and maximum temperature, at which point you begin to tap out.  Guess what amphetamines & stimulants do?

By allowing you to push past your operational limits, stimulants turn you from a person who will collapse before overheating into a person with a non-trivial risk of doing the exact opposite of that. The perfect storm Dr. Rusyniak described could be used for most, if not all of the MDMA death at festivals in recent years, especially the ones at New York City’s Electric Zoo.

The summer outdoor dance party is therefore the perfect condition for exertional heat stroke to occur. Warm environment (decreasing heat dissipation), increased exertion (dancing), use of drugs that blunt normal protective responses to exertional heat stroke.
~Daniel E. Rusyniak, MD (Medical Director of the Indiana Poison Center)

The problem is exacerbated by the fact that most usual methods for rapidly cooling MDMA users may not be applicable. That person sweating their face off/rolling so hard you can see them chewing the inside of their mouth off from 15 feet away, is probably not giving up his spot in the crowd to get water. Even if he did, especially on day 2 or 3 of the festival, hyponatremia becomes a real risk. Exertion when you’ve not had zero calories, zero sleep and a cocktail of uppers and downers amplifies this risk . This is the reason why smart festivals hand out Gatorade & salty snacks after day 1. This stuff isn’t rocket science, but it does need to be planned ahead and there are plenty of ways to mess it up if you’re not careful.

There are two other wildcards to the MDMA experience. At higher doses (you know who you are), MDMA has been seen to cause cutaneous vasoconstriction. This vasoconstriction increases your blood pressure and can hamper heat release at the same time it raises your temperature. You’ll feel exceptionally hot, and then drink a ton of water, amplifying your risk for hyponatremia. It’s very hard to troubleshoot what’s going on in your cardiovascular system when you’re running a 101 degree temperature in the middle of the dance floor during a Steve Aoki set.

The idea that you can actually overheat is real, verified science, and we need to stop pretending is a myth. It can happen and when you go hard, it’s much more likely. Take breaks, don’t party in direct sunlight for 15 hours a day (you know who you are), and try to be as consistent as you can with water. On playa, Piss Clear is well known, but I think Piss Clear Regularly, should become as important. Drink water consistently, starting early in the day, before you start feeling faint. This way, you’re not fucked up thinking you have to drink a gallon of water when your anxiety spikes and you start telling your friends you feel like you’re dying.

It’s important to build good habits that don’t involve your limits, because when you’re on stimulants of whatever that shady dealer is peddling as the purest molly this week, you might just forget they exist. Additionally, you’re not a varsity or high performance athlete. While it’s been shown that marathon runners and athletes can be cooled from temperatures exceeding 107 degrees, let’s not pretend that any festival will ever have the capacity for you to consider that a way to justify being irresponsible. If you’re LeBron, you can expect a cold water bath and sodium testing on game day; you better expect an hour wait for water and impure drugs. If you’re not LeBron, please follow these simple tips:

  • If a festival or party allows Camelbaks, BPA-free reusable water bottles or any form of BYOW, take advantage of it.
  • Know where the free water stations are at any festival. If you’re at a festival or party that doesn’t have free water, berate them on social media until they have them. Don’t pay for parties that don’t have readily accessible water.
  • If you’re one of those people who use repetitive motions when rolling to de-stress, attempt to build a habit of reaching for your Camelbak nib and taking water as one. That’s way less damaging than finding people to date or smoking cigarettes in response to the jagged energy.
  • Salty snacks and food with savory tastes are your friend, especially after day 1 of events.
  • Alcohol + MDMA = Dehydration Bonanza. Pick one. Seriously, that’s the express train to FailVille, population you.
  • If you feel like a sweaty mess, believe yourself and go get some water. If you don’t feel like a sweaty mess and you’ve been on the dance floor for an hour in direct sunlight, GO GET SOME WATER.
  • If you’re drinking, try to have at least 8-12oz serving of water for every 2-3 drinks. If you’re drinking and dancing, make that ratio as close to 1:1 as you’re able to.
  • Don’t be embarrassed if you need to slow down, take breaks, ask for help or flag down emergency services. That’s what the staff & EMTs are there for. If you try to shrug off serious symptoms of heat stroke, you’ll still need to see EMTs…you’ll be out of commission for much much longer.
  • Taking breaks earlier on are much more rejuvenating. Giving yourself breaks every couple of hours at a multi-day event can make day 2 & 3 a lot easier than forced crashing for 4hrs because you can’t handle it anymore.

Don’t try to be a super hero y’all. The summer is long, and Dr. Rusyniak & I want to make sure every single one of you see Fall 2017 as well as your favorite DJs over the summer.

War on Drugs Leads to Wholesale Rainforest Destruction

Photograph by Luke Duggleby www.lukeduggleby.com

Photograph by Luke Duggleby http://www.lukeduggleby.com

By Terry Gotham

I usually talk about how to reduce the damage drugs can do to people, but today I want to switch it up a little bit. I’m going to tell you about the Mreah Prew Phnom trees of Asia, the Sassafras trees of America, and how our voracious appetite for drugs is hurting them. This isn’t a story about water usage or gang violence, but of appetites. The explosion in popularity of MDMA has ensured one of the trees that produce a precursor substance, safrole oil, is now critically endangered. It’s estimated (not verified) that more than 5 million trees have been destroyed over the last 10 years.

Photograph by Luke Duggleby www.lukeduggleby.com

Photograph by Luke Duggleby http://www.lukeduggleby.com

 

 

Formally named Cinnamomum parathenoxylon, the tree grew in Bhutan, India, Indonesia, Laos, Malaysia, Myanmar, Nepal, Pakistan & Vietnam, but is currently most often found in Cambodia. The remaining population is clustered in the Phnom Samkos Wildlife Sanctuary, as cultivation of the tree is increasingly restricted. When the roots are chopped up and processed, safrole, an essential oil is produced. This stuff has been an herbal remedy, a critical part of perfumes, soaps & can be used to make MDMA.

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Ten Questions With Terry Gotham: Brad Burge – MAPS

(Interviewing the Multidisciplinary Association for Psychedelic Studies has been a dream of mine for years. I’m honored to present this conversation with their Director of Communications & Marketing Brad Burge. Not only does he give us an update on the SIX (6!) Phase II clinical trials of MDMA for PTSD, but he also shares totally new developments & tips on how to talk about this stuff for people who don’t quite dig yet. And a couple of his favorite tunes to boot!)
~Interview By Terry Gotham

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brad_burge1. How was 2015 for MAPS? Any good news from the front to share?
Just a little.

I can say without hesitation that 2015 was our busiest, most exciting year yet. This year (2016) we celebrate MAPS’ 30th anniversary, and all that we’ve accomplished in those three decades. Our Phase 2 clinical trials of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) are now nearly complete, and this year we’ll be meeting with the U.S. Food and Drug Administration (FDA) to plan the much larger Phase 3 trials needed to make MDMA a legal prescription medicine, approved for use in conjunction with psychotherapy to treat PTSD. We are on track for FDA approval as soon as 2021.

As one of the first steps to getting this first approval, in February 2015, we announced the formation of the MAPS Public Benefit Corporation (MPBC), a new wholly owned subsidiary of MAPS which will serve as a vehicle for conducting MAPS’ research, and for balancing social benefits with income from the legal prescription sale of MDMA, other psychedelics, and marijuana. We also initiated the purchase of one kilogram of pharmaceutical grade MDMA manufactured under current Good Manufacturing Practices (GMP) to be used in our Phase 3 trials. This batch of MDMA will cost us approximately $400,000, which we are seeking to raise this year through the Global Psychedelic Dinners and 30th Anniversary Banquet in Oakland, Calif.

Another major 2015 success is our Canadian Phase 2 study of MDMA-assisted psychotherapy for PTSD, which finally started after eight years of effort. This study has already completed treatments as of early 2016, and has been the first clinical psychedelic therapy trial in Canada in over 40 years. In 2015, we also completed and fully funded our two largest Phase 2 clinical trials, one in South Carolina primarily in U.S. military veterans, and one in Colorado primarily in female survivors of sexual assault and abuse.

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