The Drug Report
The Drug Report
Media Hype vs FDA Reality: The MDMA Decision
Why did an FDA panel recently decisively reject MDMA for medical use despite some supportive scientific studies? Join us on the TDR podcast as we grapple with this critical and controversial topic alongside our distinguished guest, Kevin Sabet. In this episode, we unpack the intricate history and ambitions of MAPS, the organization led by Rick Doblin, which transformed into the for-profit Lycos Therapeutics. Kevin offers his expertise on the mixed results from rigorous studies submitted to the FDA and the factors behind the panel's overwhelming vote against MDMA for treating PTSD. This discussion sheds light on the broader implications for psychedelic therapies and FDA regulations.
We also delve into the media frenzy and the optimistic anticipation within the psychedelics advocacy community leading up to the panel's decision. Despite the buzz and support from certain quarters, the committee's vote of 10 to 1 against MDMA underscores the complexities and risks associated with approving psychedelics for medical use. Get ready for a comprehensive analysis of this pivotal decision and its potential impact on the future landscape of PTSD treatments. Tune in for valuable insights on what lies ahead for MDMA in therapeutic settings and the FDA's ultimate stance.
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Yes or no? Do you believe nicotine is not addictive?
Speaker 2:I believe nicotine is not addictive. Yes, Congressman, cigarettes and nicotine clearly do not meet the classic definitions of addiction. I don't believe that nicotine for our products are addictive.
Speaker 1:I believe nicotine is not addictive. I believe that nicotine is not addictive.
Speaker 2:I believe that nicotine is not addictive.
Speaker 1:And hello everyone. This is Luke Neferatos. I'm your host of the TDR podcast and thank you all for listening and subscribing. I want to also thank our sponsoring organizations SAM, smart Approaches to Marijuana, which you can find at learnaboutsamorg, as well as the Foundation for Drug Policy Solutions FDPS at gooddrugpolicyorg. They make this podcast possible Today. You know there's a bunch of different news in drug policy, but I've asked Kevin Sabet to join me again on the show. Really, I think the biggest story right now that we're looking at is this FDA panel's rejection of MDA as a medical application, at least right now. Kevin, can you give us kind of a synopsis of what happened there?
Speaker 2:Yeah, so MDMA, also known as Ecstasy. There has been a long trial going on by the actual. Well, it's from a group that originally started as MAPS, the Multidisciplinary Association for Psychedelic Studies, led by Rick Doblin, who's been a long time really, drug legalization advocate 30 years plus from Harvard, sort of a student protege really of Timothy Leary, or protege of Timothy Leary, I should say, always really believed in this. Anyhow, you know he started out doing advocacy and then really has changed maps into a public company now called Lycos Therapeutics, which is for profit and essentially they were trying to get MDMA or ecstasy assisted therapy, so as an adjunct to other therapy for PTSD. That was the focus on it.
Speaker 2:Um, and so they had a few studies that they submitted uh, like those did, or maps to an FDA panel which recommends whether or not it should be, um, you know, approved by the FDA, and there was a lot of, you know, people were looking at this for a very, very long time, uh, and very concerned, and on all sides there's been a lot of research on placebo effect and how MDMA and psychedelics even when you think you're taking them, that's actually as beneficial as actually taking them. So you know essentially what happened, is they. This panel voted against.
Speaker 1:By a vote of nine to two.
Speaker 2:Nine to two on whether it's effective and 10 to one about whether the treatment benefit outweighs the risks. So you could still say it was effective. And 10 to 1 about whether the treatment benefit outweighed the risks. So you could still say it was effective. One person said, well, it was effective, but then they still said it doesn't outweigh the risks. So 10 to 1. And this is not binding on FDA, but it would be unusual in this case, I think, for the agency not to follow the recommendation here. This is really unchartered territory and I think we should expect something by the summer, end of the summer. But I think this is unchartered territory.
Speaker 1:Well, kevin, I think what I thought was you know, there was so much of a media and online frenzy around this hearing. You know, for those of us who follow the psychedelics advocate community, they were very excited about this hearing. I think there were a lot of people that expected it to come out favorable to MDMA being useful for PTSD, even though we were starting to see some of the concerns from the scientific community, because there was a big NPR article that raised concerns about these studies that Lycos slash MAPS had submitted, and then there was a big expose on Doblin and MAPS as on just all the various awful things going on under the hood there, and so I think we saw some concerns rising from the scientific community. But there's been so much excitement that it is very striking. This committee vote was so lopsided, don't you think?
Speaker 2:Yeah, no, absolutely, and I think this is really big money I mean the FDA ruling if they go ahead and agree, which again I don't think they will- and again they have overruled their committees before.
Speaker 2:In this case, this is uncharted territory. A lot of this is very unique for FDA, just because not only is it psychotherapy, but it also, you know, it doesn't. Fda does not regulate psychotherapy, it regulates medicines. So it hasn't ever really evaluated a drug, you know, whose efficacy is tied to this, what they call talk therapy. So I just don't, I just don't see it happening.
Speaker 2:But if it did, it could turn Lycos into a multi-billion dollar company, according to one investor, at least in this Business Insider article, which was the expose of Rick Doblin. I mean, yeah, I mean, look, the ketamine-based nasal spray that Johnson Johnson has, which is called S-ketamine nasal spray for depression, has had global sales of half a billion dollars already last year, has had global sales of half a billion dollars already the last year. So you know there is big money here and a lot of people um have invested a lot of people, a lot of people on the right, interestingly, um have or it's not really a right left issue in some ways- yeah, but uh, perry, or um, not not scott perry, the former governor from texas, um, who is Rick Perry, who's all over this.
Speaker 1:I mean he's beaten the streets for the psychedelics, but it's really interesting. Aaron Weiner, who's been on the show before and he's a good friend of ours. He kind of listed some of the bullets of the key reasons this group gave for why the benefits do not outweigh the risk, and I just thought they were pretty striking. I mean, very little information was collected about the potential for misuse and addiction, despite an explicit FDA recommendation to do so. So they didn't even look at the harms in these studies the addiction potential, the misuse potential, lack of evidence supporting the novel approach to psychotherapy, sexual misconduct during a trial between at least one participant and two therapists in these studies, yep, at least 40% of those enrolled had a history of using MDMA prior to the study. I mean, the list goes on and on. There was whistleblower reports. These are things that are all in the list of reasons why this didn't proceed forward. So I just think this was kind of a stand by real scientists against what appears to be not very scientific evidence, at least in this case.
Speaker 2:Well, it's not surprising this has become a religion for people Again. Know, I mean rick doblin grew up in a in a suburb of you. Know he grew up in skokie, I think. Uh, as a quote-unquote I think he used the term once for a press teenager or something and then sort of discovered drugs, like so many people did in the early 70s when they went to college and and just became enamored. He was a disciple of the famous czech psychiatrist who has done a lot of research on LSD, stanislaus Grof, and you know this was something that he was very, very committed to and you know, basically he figured that you know MDMA frankly, more than LSD actually, or even something like peyote. Like the indigenous practitioners, mdma was his drug always of choice, and so he's been doing this ad hoc since you know, the early 80s, literally giving MDMA therapy sessions to friends and saying that it just did, it's done really great things.
Speaker 2:And now that the scientific community is looking at this, they're saying not quite. So I think it's really a wake up call for this, the total hype around psychedelics. Look, I think we all want any drug to be helpful for folks and we certainly didn't. I never opposed the esketamine trial and it went through the proper channels. But this is going through the proper channels and it's not passing those channels. I wouldn't be surprised if this. You know, if they keep getting rejected, they're going to go back to the ballot box, like they did with medical marijuana. That wouldn't be surprising to me.
Speaker 1:Not at all. Yeah, it would not be surprising at all. So, okay, well, good news there. We'll continue to follow up on kind of what's happening with Lycos. I do think you know, I think everyone knows, I'm Greek, or at least half Greek, that is, and study a lot of Greek history. And you look at Lycos. Lycos was one of the children in Greek mythology of Dionysus. So do with that as you will, do with that as you will historically. So anyway, moving on, the CanRA Association of Cannabis Regulators had a meeting or is currently having meetings, I think, and had kicked off their meetings yesterday in Minneapolis to talk about the state of the marijuana industry and regulation. And, kevin, you wrote a nice piece in our drug report which, for those of you who are subscribed, you would have received that If you did not. Please sign up at the drugreportorg. But, kevin, maybe you can talk a little bit about what led you to write that piece and just kind of what these regulators need to be hearing right now.
Speaker 2:Yeah well, I think it's an interesting group that's come together. There are some people from the FDA I mean the former president of this group. He is now one of the people that wrote the FDA my understanding wrote the FDA recommendation to reschedule marijuana. I think it's a little bit of for me an uneasy mix of industry folks, sympathetic people to the industry, as well as regulators, many of whom come from the industry and many of whom are greatly influenced by the industry. That said, I think the executive director, gillian Schauer, and some of the other folks do have very good intentions here. They want to see some kind of real guardrails.
Speaker 2:This was simply a call for that. It was trying to elevate that voice of more guardrails in these legal states, because we really haven't been successful in we, as in the collective field, have not been successful in passing a lot of these guardrails, because the industry is so strong and the regulators already feel like they're under a lot of pressure from the industry because the industry is telling them that their tax too much, there's too many regulations, whereas you know, we all know that they're barely any regulations. So you know, I think it's a very interesting meeting, uh and um. I was glad that john colpitt's rosalie cooler were going and speaking, so that's very good, but it was really kind of a call to action for those that do want to see some real tightening of what's happening in these states.
Speaker 1:Yeah, very interesting. Unfortunately, you see a lot of these industry summits for regulating the industry and it's bankrolled, it's sponsored, it's loaded with industry advocates and industry members themselves, and so obviously you know you see them be a part of it, you expect to see them be a part of it, but you would hope that there would be a sizable public health aspect of this a policy project. These are groups that have paved the way in gold for the industry and they're not at all interested in doing sensible things like capping potency, for example, or eliminating advertising, things that are not controversial in public health but are controversial for industry interests.
Speaker 2:So hopefully we'll see more commitment to that in the future.
Speaker 2:Yeah, and interesting one thing that's happening simultaneously and I know you're going to be going today is the Recovery Leadership Summit in Denver from Faces and Voices of Recovery, one of the legacy groups that have been focusing on recovery for a while, and Patrick Kennedy, our co-founder of SAM, just spoke about an hour ago, where he really hit very hard the issue of marijuana as a for-profit industry that's countering public health and basically saying that if people with substance use mental health issues really need to wake up to this addiction for profit. I heard it was extremely well-received. I do think that there is really an appetite out there to raise awareness about addiction for sort of tackle. Some of that. I'm not too sure that they did. I hope they did, though.
Speaker 1:Yeah, yep, definitely. I'm looking forward to joining up with Patrick here literally just a couple of hours, and we're going to have some events through the end of today in Denver as well as tomorrow. So for those who are in Denver, denver health is rolling out some really exciting new stuff in terms of mental health and addiction treatment, so keep your eyes peeled for that. Well, I think that wraps up that stuff. I mean, kevin, you know, obviously the big topic right now in people's minds related to marijuana policy is rescheduling. Any kind of update from your end on rescheduling that you want to fill our listeners in on before we wrap up?
Speaker 2:Well, I just think we need to keep getting those comments in. You can go to our website, learnaboutsamorg. If you click on the first slider marijuana rescheduling you can speak out now and oppose it. You click on the button. There's a message already there for you and, yeah, it's definitely something that you know. We saw Katka set theirs today, which is great. You know, I think I don't know what the last number of comments. There's already a lot of comments, um, but, um, yeah, I think that this is really something that needs to be out there. Um, people need to get their voice heard and we need to. You know, I I think this is a long way coming. I think there's a lot we can do and a lot that is happening before we actually um, you know, this actually gets rescheduled.
Speaker 1:Yep, so definitely make sure you put your comment in. We send an email to everyone. Again, you can find that on our website, learnaboutsamorg. Public comment is key. These agencies are required by federal law to consider public comment, so your voice does matter here. So anything we can do to help you with that, let us know. We're also going to have a Q&A kind of forum virtual forum on rescheduling for folks who want to submit comment next week, and we sent an email about that yesterday. If you didn't get that, go to learnaboutsamorg. Subscribe for our emails. We'll be sending reminders. We will be able to get all your questions answered as it relates to public comment and what to do there.
Speaker 1:But it's very clear it's a controversial process. There, I think, are a lot of very unexpected things that are going to be coming up as we get through this process. So stay with us. We'll be giving you updates as we get them, as we have been doing here on the TDR podcast. So, kevin, thank you for joining us, thank you to our listeners. We hope you have a great rest of your week and again, wherever you're listening to the podcast, please give us five stars, leave us a good review that makes a big difference and again subscribe to our newsletters and our podcast at thedrugreportorg. Thank you all, thank you.