Summary: Terry Gotham of Burners.me interviews Brad Burge of MAPS about MAPS’ recent milestones with clinical trials of MDMA-assisted psychotherapy for PTSD. “We expect that MDMA-assisted psychotherapy will be approved as a legal treatment for PTSD by the FDA as soon as 2021,” explains Burge. “The approval of MDMA-assisted psychotherapy for PTSD is likely to change how our culture understands and treats mental illness.”
Originaly appearing here.
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Interview by Terry Gotham
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.
2. By the time the Phase III trials are done, do you have a sense of how many people will have received the treatment? Will it be Dozens? Hundreds?
We had 100 participants in Phase 2 clinical trials, all of whom had chronic, treatment-resistant PTSD, and we will have another 200-300 in Phase 3 trials, for a total of 300-400 total participants having received MDMA-assisted psychotherapy in MAPS-sponsored trials. Thousands more than that have received MDMA and other research contexts, including basic safety studies sponsored by the National Institute on Drug Abuse (NIDA).
3. Not to be too hopeful, but what is your post-approval plan? How does this scale, what does PTSD treatment with MDMA and MDMA therapy occurring look like? Is it rolled out state-by-state or nationwide?
There’s no reason not to be hopeful! We expect that MDMA-assisted psychotherapy will be approved as a legal treatment for PTSD by the FDA as soon as 2021, as long as the Phase 3 results are comparable what we saw in Phase 2. MDMA will not be a take-home treatment so people will never get a prescription to go fill themselves at the local pharmacy. Instead it will only be available as an inpatient clinic, only administered in certified clinics by certified practitioners, and patients will get safety screenings to make sure they don’t have any conditions that make MDMA too risky. MAPS and others will be establishing clinics where people can receive MDMA-assisted psychotherapy for PTSD, and I know there are lots of therapy centers and private practitioners now who are planning to offer it once it is available. This will happen on a local basis as well as state-by-state and nationwide, since there will be a lot of work involved in getting it covered by insurance plans and government healthcare. We’ll also be training many thousands or tens of thousands of therapists in how to administer the treatment.
4. Besides the survey MAPS is currently collecting data with, are there any long-term plans to evaluate microdosing? Any tips for cutting through the media haze for true best case practices for intrepid psychonauts?
We’re not currently doing any surveys on microdosing, though the Beckley Foundation in the UK is planning a study of LSD microdosing. I think the key message is that there has been very little if any actual research on microdosing, though there are people out there who claim to be sharing scientifically-based information. We also see a lot of media reports about how microdosing is all the rage in certain social circles, like Silicon Valley. Even though it certainly is a growing trend, we need to take all of those reports with a grain of salt and remember that headlines tend to blow things out of proportion.That said, there is some good information available about the effects and risks of LSD, psilocybin, and other psychedelics that are used in microdose quantities, like from Erowid and DanceSafe.
5. Do your teams have contingency plans in case Sessions goes crazy? Is there a Sword of Damocles feeling in the trenches these days, or have too many minds been freed to keep the ball from rolling back down hill?
There is very little that the Justice Department can do to prevent federally regulated, FDA-reviewed, placebo-controlled, double-blind clinical trials from taking place, other than potentially making it more difficult to obtain DEA Schedule 1 licenses for the research. But based on our experience just last week, when our Executive Director Rick Doblin and members of our research team met with administrators at DEA headquarters, it’s clear that the DEA is supportive of the work we are doing and is interested in facilitating it. So, any sort of resistance from the DEA at this point to MDMA-assisted psychotherapy research, or from any other part of the Justice Department, seems extremely unlikely. That said, there is no such thing as a sure thing. We are being exceptionally careful not to overstate research findings, exaggerate the potential benefits of psychedelic therapy, understate the potential risks and side effects, or proselytize in any way. The best we can do now is to make sure the research gets funded, and wait for the results of the decisive Phase 3 trials.
6. Besides donating to MAPS and supporting them on social media, how best can everyone who is just looking at their watch waiting for the decriminalization, medicalization, and even legalization of America’s most popular drugs support MAPS and stay on top of emerging research scientists affiliated with you are working on?
Well, first I might ask whether psychedelics and marijuana are really America’s most popular drugs—a quick trip to the corner store might give you a better idea. Also, legalization of psychedelics is not so much our goal, rather than encouraging responsible and safe uses based on scientific evidence. The best recommendation I can give is to find ways to connect to the psychedelic Science and therapy communities at one of the many in person events that are happening all over the world from conferences, like the annual Horizons conference and more occasional Psychedelic Science conferences, or MAPS Global Psychedelic Dinners, and attend lectures and trainings at Burning Man and other international festivals. That, plus donatingand spreading the word on social media.
7. What is the stupidest thing you’ve ever been asked, in a professional capacity? What is the smartest thing you’ve ever been asked in that same capacity?
It’s more of a bad joke than a stupid question, but I can’t count how many times I’ve been asked if MAPS gives out free samples. (We don’t.) I don’t think I’ve ever been asked this seriously, but really, what do people really think the chan
ces are that we haven’t heard that before? The smartest question we’ve ever gotten—and we’ve gotten this one a lot—is, “How can I help?”
8. Is there something the media gets wrong about how MDMA helps those suffering from PTSD that you wish you could just wave a magic wand and correct?
The media don’t emphasize nearly enough that MDMA is not supposed to be a treatment in and of itself, but is rather a tool to help the therapeutic process. It can be too easy to get stuck in the old pharmaceutical model, where it’s assumed that people with PTSD have to take a drug every day for the rest of their lives in order to feel better. The story here is not just of an illegal drug transforming into a legal medicine, but of an entirely new approach to psychotherapy, psychiatry, and the treatment of mental illness that is not about reducing symptoms but about giving patients the tools they need to heal themselves. So if I could ask journalists and people working in media to do one thing, it might be to remember that psychedelic science is not just an evolution of drug policy, but also of psychiatry.
9. Any tips for talking about psychedelics, MDMA or MAPS to family members at the dinner table around the holidays?
I think it’s best, when starting conversations about psychedelics, to start with where people’s interests already are. If someone isn’t interested in trauma or mental illness, then that might not be the best way to engage them in conversations about psychedelics. Instead, ask them questions about who they are and what they’re interested in, and make the connection from there. For example, do they know somebody who served in the Armed Forces? Have they ever known anybody with PTSD? Have they ever had a positive, or even a difficult, experience with psychedelics themselves? Are they from an area that sees a lot of deaths due to opiate overdoses? Have they ever known anybody to be unfairly incarcerated for possession of a psychedelic or marijuana? Are they suspicious of Big Pharma’s approach to pharmaceutical drugs? Or do they not care about any of those things and instead just want to talk about the weather? In my experience, with any kind of stigmatized subject, it’s best not to push the issue unless you can find a way to connect it to someone’s interest—but fortunately, with psychedelic science, there are a lot of ways to do that if you’re educated. It also helps to remind people that psychedelic science isn’t just a fringe thing any more, and people are coming together from all sectors of society and government to help the research move forward.
10. When MAPS and its allies win, and psilocybin, LSD, MDMA, and maybe even Ibogaine, are being used medicinally, what does America look like?
I think that there will be a whole new wave of people interested in becoming professional therapists, psychiatrists, and researchers, because these are not just new drugs to be incorporated into medical treatment. Like antidepressants, antipsychotics, antibiotics, and many others before before them, they represent an entirely new class of psychopharmaceutical as far as our medical establishment is concerned. I also think that these treatments will bring with them a more holistic, compassionate, and person-centered approach to treating mental illness, one that sees people as fundamentally capable of doing their own healing and not relying on drugs to make them better. In other words, when psychedelic therapy is a legally available treatment, I think we’ll be seeing more people living happier lives with fewer drugs.
(Postscript: Personally, I strongly believe in and endorse highly, MDMA-assisted psychotherapy for PTSD. It is, far and away, the most important and effective treatment we have for the flood of traumatized citizens in this country. Cops, Firefighters, veterans, victims of sexual assault, and many others have no good option for treatment. But MDMA-assisted psychotherapy and medical cannabis treatments offer proven symptom reduction and help to those who need it. MAPS did not compensate me in any way for this post, I simply believe this is one of the most important things that we actually have a chance to make happen as a society. If you’ve got something extra when you’re done holiday shopping, they could use it.)