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Brian Lehrer: It's The Brian Lehrer Show on WNYC. Good morning, again, everyone. If you were listening to our HIV-related segment before the news, here's another very different public health topic. The Food and Drug Administration of the federal government is currently considering MDMA as a treatment for post-traumatic stress disorder, but the agency raised concerns last week citing flaws in the studies that they're looking at to decide on regulating, or deregulating.

You might know of MDMA as ecstasy or Molly. Sometimes ecstasy is used to talk about the pill form of MDMA, while Molly is usually referring to a powder, sometimes put into a capsule for ingestion, and it's supposed to be a purer form of MDMA. According to the National Institute of Health, MDMA's effects may include, "Feeling more energetic and alert, and having an increased sense of well-being, warmth, and openness toward others."

The NIH also says, "While rare, overdoses can happen." The FDA has said that bias has seeped into the studies, herein lies the problem, because both participants and therapists were able to figure out who got MDMA versus a placebo. They also pointed out some, what they call, significant increases in blood pressure and pulse rates that could trigger cardiovascular events, this according to recent reporting on those studies in The New York Times.

The fight to get MDMA in front of the FDA goes back decades, and here to explain how we got to this moment, and what comes next is Anna Silman, Features Correspondent at Business Insider. Her latest piece is titled, MDMA therapy could be legal by summer. Why are so many advocates sounding the alarm? Anna, thanks for coming on. Welcome to WNYC.

Anna Silman: Hi, Brian. Thank you for having me.

Brian Lehrer: Let's start with the drug itself. How does it work in the brain, and why do some researchers think it could help treat PTSD?

Anna Silman: Like with a lot of these drugs, we don't know exactly how it works, but it seems that MDMA's increase in serotonin that it prompts in the brain, that creates those good warm feelings that you described, can also then be helpful for patients with PTSD in enabling them to talk about traumatic memories, or process difficult emotions that they wouldn't otherwise be able to access. [crosstalk] There's been a number of--

Brian Lehrer: Go ahead.

Anna Silman: Sorry.

Brian Lehrer: No, I'm sorry. I apologize.

Anna Silman: Yes, I think there's been a number of studies that have shown a pretty significant reduction in PTSD symptoms in people who've done this MDMA therapy.

Brian Lehrer: You write in your piece that the government named MDMA a Schedule I substance, and for listeners who don't know drug classification under the law, that's a legal category reserved for really dangerous drugs, like heroin, with high abuse potential, and no accepted medical use. Can you give us a quick history of the drug, and why it was categorized as a Schedule I substance in the first place in the way that you define Schedule I there?

Anna Silman: Yes. MDMA was patented in about 1912. It's been around for a while, but in the '80s, especially, it became popular both with clubbers and ravers, and also with a small population of therapists in the United States, who saw its potential as a therapeutic tool. There was also a ensuing moral panic about these ravers having their brains turned into goo.

There was a lot of propaganda about MDMA potentially causing holes in your brain, which was later debunked, but as a result DEA then criminalized MDMA in 1985. They placed it on Schedule I, deeming it as a drug with no medical benefit, and high abuse potential. What some MDMA advocates said was that this was wrong, that this never should have happened, and they spent the next four years trying to get that overturned.

Brian Lehrer: Your article in Business Insider is largely about a 70-year-old activist named Rick Doblin who founded a nonprofit called the Multidisciplinary Association for Psychedelic Studies or MAPS in 1986. You write, "He's a big part of why your grandma's asking you about magic mushrooms, and TikTok influencers are trying to sell you ketamine therapy in between dance challenges and makeup tutorials." [chuckles] We'll just note that, yes, that's what MAPS is doing. Can you give us a bit of background on Doblin, and his influence in this field?

Anna Silman: Yes. Rick is, he's incredibly influential. I was at the conference that they held last summer, and he was really treated like a celebrity amongst people in the movement. He has been crusading for almost four decades to get MDMA legalized, he started MAPS the year after the DEA criminalized MDMA, and he was involved both in raising awareness around psychedelics and in their promise, and also in spearheading the crusade to take MDMA through the FDA's clinical trial process, and ultimately get it to the point where it could be approved as a treatment for PTSD. That's what we're on the cusp of right now. It's really Rick's odyssey that has paid off.

Brian Lehrer: We'll get into the FDA review process in just a second and in what context, they've discovered bias in some of the studies, which is apparently making it harder for them to reach a conclusion one way or the other. I also want to open up the phones. Listeners, anybody out there, an MDMA user for things other than dance challenges and makeup tutorials? [chuckles] Anybody, in all seriousness, ever use MDMA in a therapeutic context, either as a user, or a therapist, maybe guiding an MDMA experience or a series of them for therapeutic purposes, PTSD or anything else? 212-433-WNYC, 212-433-9692 for Anna Silman, Features Correspondent for Business Insider covering this process and how close it may be, but with obstacles for MDMA to be approved for PTSD treatment. 212-433-9692, 212-433-9692. Who has experience with this, or a question, call or text.

Anna, you write, and I'll tell the listeners, in 2014 MAPS launched a public benefit corporation to focus on legalization. This February that entity recently named Lykos Therapeutics announced that the Food and Drug Administration had accepted its application to use MDMA to treat PTSD, and granted it an expedited review. That brings us to last week when a staff analysis was conducted for an independent advisory panel that will meet tomorrow, I see, to consider that application. Can you tell us more about the FDA's concerns?

Anna Silman: Yes. The FDA released some documents ahead of that meeting tomorrow, which is basically composed of a group of independent scientific advisors. They said that one of the big issues is that, the trials are functionally unblinded. Blinding means that you don't know whether you've received the treatment, or a placebo, but because it's so easy for people to tell if they are on MDMA, functionally, that the blinding didn't happen.

As a result, there's a concern that there's bias. People who know they've received the drug, basically, want it to work, and that the investigators want it to work also, and as a result that that might have skewed the data in favor of the very positive outcomes we've seen. There's also concerns about limited data on adverse events, so some cardiovascular issues, and also concerned that negative adverse events weren't captured to the full extent.

There's also questions about, is it the therapy that's helping, or is it the drugs, because everyone in the trials received a number of therapy sessions, and they're basically saying, "Do we have enough data to prove that this is a successful intervention, given the possible risks?"

Brian Lehrer: How would they even design a study that would be double-blind in the way you described, in the way they generally try to design studies when they can, because like you said, you know if you're on MDMA compared to if you're on nothing, because the physical and emotional effects are so dramatic. How can they have MDMA versus a placebo, and draw anything from that kind of study? There must be other ways to study.

Anna Silman: Right. It's a very difficult thing to do, and it's an issue with a lot of psychological drugs that influence your psychology, but of course, especially psychedelics. There were other ideas proposed, including giving people a stimulant in the placebo group, or giving them a very small dose of MDMA, but there were issues with those approaches too.

What they've done here is they instead had independent raters, who watched the sessions who were unaware if the participant had received the MDMA or not. Also, the FDA-approved MAPS on Lykos's trial ahead of time, so they didn't know that this functional unblinding was going to happen. It's not a surprise. It's just obviously something that could have ramifications on the results.

Brian Lehrer: Again, MAPS stands for the Multidisciplinary Association for Psychedelic Studies, now known, I guess, or one of their subsidiaries known as Lykos Therapeutics, and that's approving, who's filing for the approval from the FDA. Let's take a caller with someone with a personal experience to share. Alex in West Orange, you're on WNYC. Hi, Alex. Thanks so much for calling in.

Alex: Thank you so much for having me.

Brian Lehrer: Tell us what you'd like to tell us. [crosstalk] I don't want to put words in your mouth, yes.

Alex: Sure, yes. No, of course. I have experienced anxiety and depression my entire life. As an adult, I became aware of MDMA as a therapeutic tool. Since over the last four years, I've worked with a facilitator on several occasions taking an MDMA, he's there with me, we have preparation sessions, we have the actual dosing session, and then integration afterwards.

I can say that decades of therapy and two decades of SSRIs did practically nothing to actually help me with the underlying issues that were driving my anxiety and depression, and three to four session of MDMA--

Brian Lehrer: SSRI is being that common category of antidepressant. Go ahead.

Alex: Correct. Three or four sessions of MDMA with a facilitator was absolutely life-transforming. It's a lot of work. It's not, "Oh, you take this pill, and your problems are solved." There's a lot of work that has to go into the process, and its an ongoing process. It's not a quick fix, but it really radically transformed my life in so many positive ways, where the anxiety and depression that really defined me in my relationships, became so much more manageable, and something that I could actually really approach head-on in a way I never could through traditional therapy.

Brian Lehrer: Can you describe for our listeners, Alex, the mechanism at all that you think worked on you? If somebody takes MDMA, and has a profound positive experience, but then you come down from the high, how do you take that with you into the rest of your life? Is it possible to put into words?

Alex: Yes, it's such a good question. I also think it's important to say that a positive experience is-- It's not like an awesome time, [chuckles] necessarily. I know people use this in a party context. I never used MDMA as a party drug. I've only ever used it in this context. You go through this experience, you're able to revisit moments in your life that had something to do with shaping your emotional state, and then after--[crosstalk]

Brian Lehrer: Including terrible, traumatic moments, you're saying, as part of this experience. It's not just. "Wee. I'm high."

Alex: Oh, absolutely. You really don't feel high. You have a clarity that you just don't have with the noise of day-to-day life. Then afterwards, you do a lot of, what's called integration, where you work with a facilitator. It's almost like therapy, what you'd imagine talk therapy to be. You just keep processing it and journaling. Some days are really hard. You're digging up some stuff that you maybe never dealt with before in your life, and that's not easy, but the mechanism of the MDMA, it allows the kind of fear that might have been associated with those experiences. It separates them from you, [chuckles] so you can look at it without being taken over by the emotions that were--

Brian Lehrer: Yes, I understand. To one of the concerns about the studies that Anna was raising, and we'll bring her back in as a reporter on this story in just a sec, but one of the concerns that the FDA has apparently before allowing people like your therapist to do this legally, is maybe it's the therapy. You talk about all the work that goes into it. Maybe your therapist is really, really good, and you don't need the drug with its potential side effects. In your experience, how would you answer that question?

Alex: Look, I did therapy, psychiatry, I spent thousands of dollars on that, probably, collectively over most of my adult life. I feel traditional talk therapy scratches a cognitive itch. It's very intellectual, but it doesn't kind of get-- For me, it did not get to the in-your-body emotions that are-- You can't just talk yourself out of these things. I do think talk therapy can be really effective for people. I enjoyed being in therapy, but it always worked on a intellectual level for me. What MDMA really did was allow those defenses to drop-

Brian Lehrer: More on the emotional level.

Alex: -in a way that would have been totally-- Yes, it just wouldn't have been effective. It's just all in your head.

Brian Lehrer: Alex, I really appreciate, and I'm sure our listeners really appreciate you opening up the way that you have. I'm sure it wasn't necessarily the easiest thing to do, so thank you. We really appreciate it.

Alex: It's my pleasure. Thank you.

Brian Lehrer: Back to our guest, Anna Silman, reporting on the legalization application for therapeutic use, particularly, with PTSD sufferers for MDMA. Anna Silman, Features Correspondent for Business Insider, who's been reporting on-- Boy, we had the poster patient there, didn't we?

Anna Silman: Wow. I mean, I think that is part of the reason there is so much excitement in the field, and so much urgency, is you do hear these amazing transformation stories in a field where there hasn't been new treatments for a long time. It is compelling.

Brian Lehrer: Here's Hugo in Sunset Park, who may have had a different experience. Hugo, you're on WNYC. Thank you for calling in.

Hugo: Hey, Brian. Hey, Anna. Hi. Right, I had a different experience. I did take MDMA once when I was 20-years-old, had a very positive experience. I would say that was a therapeutic event unto itself. It wasn't intended as such, but it was. It ended up being-- It was wonderful. I recently, I think it was-- I forget the year, maybe it was during the pandemic, or slightly after. I had a sound healing with a dear friend, who's done great work. Great, great work in areas of healing using substances.

I'm not going to, but-- I had a sound healing with that person, and it involved MDMA and psilocybin, another substance which I also used in my youth during college, again, in positive ways, and some negative. It had some negative effects as well. Anyways, I did a healing, and while it was a really, really positive experience, towards the end of it, the people that I was doing with the healing with, I'm not sure were properly trained, in that, they could guide me out of any pitfalls, because of the-- What happens in the experience. I do remember when I did MDMA 20 years ago, I guess it was when the serotonin levels of your brain get depleted, something you have.

You have kind of a bad trip at the end for a bit. I was feeling not very paranoid, very scared back then, and then I put some [unintelligible 00:19:35] on and it was wonderful again, towards when daylight came up, whatever. This time, they didn't quite-- My mind went to really negative places and they weren't able to therapeutically talk therapy style, or pull me out of that. That left a really negative imprint on my brain. That itself might have been, I think I might suffer from some PTSD to this day, because of that incident. It has shaped my worldview.

Brian Lehrer: Interesting.

Hugo: In a- [crosstalk] I'm more anxious now.

Brian Lehrer: Based on your experience coming out with more anxiety, as you're describing it, and listening to the previous caller, if you heard her with how-

Hugo: I did.

Brian Lehrer: -much this helped her long term as she's experienced it, do you have an opinion on whether it should be legal or illegal, because that's the question before the Food and Drug Administration, for MDMA therapy to be used by therapists on people who want to do that?

Hugo: I feel it should be legal, but it should clearly studied. I'm a pretty liberal person in terms of trying and accepting new methodologies of treatment, but I do think it needs to be-- That's the thing about science though. I was just reading about how we came upon-- It was a Reddit thread. How we came up on so many scientific methods. It was not an easy path for the people that they were being tried on, or the people that were trying them. It's like-

Brian Lehrer: For you-

Hugo: Yes, I do.

Brian Lehrer: -legal, but really communicate the risks.

Hugo: Yes, and figure out a way to try to manage the risks a little bit.

Brian Lehrer: To manage the risks, and also accurately study. I guess, Anna, the prevalence of the risks, which is the issue before the FDA. They don't feel that they have a clear scientific epidemiological picture, right?

Anna Silman: Right. I think there is a concern that there's so much hype around the drug, especially, within the psychedelics movement and within MAPS, the organization that sponsored the trials, that there used to be the war on drugs mentality, where there was a ton of fear around drugs, there was very little research. I think some feel now that the pendulum has swung the other way, and that there's so much hype, and nobody wants to hear about the risks. I think we've got to strike that balance, and it's very difficult.

Brian Lehrer: It's a perennial question for the FDA when deciding whether to legalize any kind of medication or drug. What does the prevalence of the benefit have to be compared to the prevalence of the downsides for users for them to get involved? We're not going to go more into that now, but there could be a very libertarian approach to that, which says, "Well, the government should take a very light approach to ever banning something that doctors and patients, or in this case therapists, who may or may not be MDs, and patients, find useful. On the other hand, they want to be cautious in legalizing things that could do a lot of harm, and have that kind of blow back on people's lives."

Let's take one more call. Here's Victoria in Manhattan, who says she's a therapist, and has a client who had an interesting experience. Victoria, you're on WNYC. Thank you for calling in.

Victoria: Thank you. Thank you so much. I'm actually a really, really good therapist. [chuckles]

Brian Lehrer: [chuckles] A humble one too, right?

Victoria: I utilize-- [laughs] It's interesting work. There's lots of different techniques and interventions, and honestly, sometimes people are really stuck, and when they're really stuck, it's hard to move them forward. In my experience with a client who recently had an experience, I just made sure that the person that he was going to was trained. There's no license. It's not regulated, but I was comfortable enough, and we had many conversations about it, and they reported a really big benefit.

I think that the struggle for me would be, it's like a mix with between Alex and Hugo. The person gets so much benefit from it that they will continue to do it, and it could lead to a Hugo experience, where at the end, it might not be so beneficial, because I've heard this a lot. Actually, a lot of celebrities who've used some of these psychedelics like psilocybin, MDMA, they talk about having great benefits in the beginning, and then if something happens, and then they stop doing it, but they always report that the treatment has been helpful.

Brian Lehrer: You'd support legalization?

Victoria: Regulation, highly licensed. I wouldn't do it maybe 5, 10 years, if I was trained, but I think that that's really important. You want to make sure that you are going to somebody who is trained. It's really, really important.

Brian Lehrer: Victoria, thank you very much. Really good therapist, Victoria in Manhattan-[chuckles]

Victoria: [laughs] Thank you.

Brian Lehrer: -calling in if she does say so herself. To wrap it up on a couple of points, Anna, one, what would this cost if it is legalized, because we have-- Who would the manufacturers be, because we have a text message from a listener who writes-- Wait, I had it in a minute. Bah-bah-bah. "Oh, is part of the problem, lobbying from pharmaceutical companies?" I think the listener means lobbying against it, because they don't have their hooks in it.

Anna Silman: In terms of cost, we don't know what it will look like exactly. There's never been something like this. It would be the first of its kind. The only real analog we have is in Australia, where medical MDMA was legalized last year, and their treatments are expected to cost about $20,000 for single course of session, which is obviously a ton of money, and very prohibitive.

I think there's a lot of concern in the movement, especially, in the drug decriminalization world, that this is going to become a treatment that only the wealthy can get access to. In terms of lobbying, it's complicated, but since MDMA is off patent, that means that in a few years, lots of pharmaceutical companies could feasibly get involved. Right now, we would be in something called the data exclusivity period, which is, I think it's five to seven years that the company that brings the drug to market, is the only one that can use their research to sell it.

That is Lykos, which is MAPS's subsidiary. They are the ones who've done the trials. They are the ones who have brought the application to the FDA, and they are the ones who, if MDMA is legalized, they will be leading the charge for the next few years. They stand to obviously benefit financially hugely, if that does come to fruition.

Brian Lehrer: How crucial is this meeting tomorrow, I guess, an FDA meeting? Are you going to be able to post on Wednesday, whether it looks like it is going to be legalized for therapeutic use for PTSD?

Anna Silman: It's very crucial, in the sense that, there will be a lot of experts weighing in. The public will have an opportunity to weigh in, which is really important, but ultimately, I don't think that we are going to know for sure until August when they announce their ruling. Perhaps, there'll be some indications based on, if the tenor of the remarks from the experts is really guarded, or really negative, but I suspect ultimately the FDA has some deciding behind closed doors to do. Still it's going to be a very interesting meeting, and I'm excited to see what happens.

Brian Lehrer: Anna Silman, Features Correspondent now at Business Insider. Her latest piece is titled, MDMA therapy could be legal by summer. Why are so many advocates sounding the alarm? Thanks so much for coming on.

Anna Silman: Thanks for having me.

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