Chapter 1: What is the main topic discussed in this episode?
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I am here with Robin Carhart-Harris. Robin, thanks for joining me again. Thanks for having me on. So remind people where you are doing your research on psychedelics. I'm at the University of California, San Francisco. I have my lab there. What's the focus of your research at this point? It's consciousness science and how it's encoded in brain activity. That's a big part of it.
How can we use psychedelics to try and tackle that question? And it translates into therapeutic applications of psychedelics as well. I also look at harms. Yeah, so try and cover much of the full gamut of psychedelic science and research. Yeah, well, I want to get into all of that. I guess, big picture to start, what are your impressions of the state of the field at this point?
Where are we with research on psychedelics and therapeutic potential and safety? I mean, how vulnerable are we to having the rug pulled out from under all of this by some new regime of there being a war on drugs? I mean, what's your perception of the field, high level? Well, it's rich and complex.
We rode a wave through a kind of peak of a hype cycle, perhaps after Michael Pollan's bestseller, How to Change Your Mind, published in 2018. And yeah, there was a period of some correction, you might say. There was a bit of a pushback on this space for different reasons. And I think there was a market correction as well. Some of the psychedelic medicine companies had gone up to a
pretty high valuation, a couple of billion dollars, I think, one of them. And they're certainly not there now. So something's happened. We had Lycos seemingly close to getting FDA approval for MDMA therapy for post-traumatic stress disorder, but that was denied by the regulators, by the FDA. And so that put it dent in the road. I do think that there are reasons to be optimistic, though.
If you look at the research, there's a heck of a lot of research. I mean, there's more than ever. The publication, you know, rate and volume is higher than ever year on year. And, you know, more quality trials, bigger trials. So I still feel that, yeah, we're knocking on the door of If FDA approval is the prime milestone, I still think that that's achievable and probably quite close. Yeah.
So what's your sense of all of the research to date that we're relying on to kind of organize our intuitions about the therapeutic value of psychedelics? I mean, much of it, I think, is probably underpowered and many things probably haven't been replicated. There's just a widespread in science now, there's a greater sensitivity to the possibility that results will not replicate.
There's obviously a replication crisis so branded in the social sciences and psychology. What's your sense of the quality of the evidence that we're hurling at the FDA or likely to hurl in the near future so as to argue for the therapeutic value and legalization? Well, there's a lot of small studies published. A few of them have come from myself and my colleagues.
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Chapter 2: What is the current state of psychedelic research?
This is psilocybin therapy for treatment-resistant depression. And that's the most advanced. That's the closest to a breakthrough, I would say, with the regulators. Yeah, they're talking about this rolling submission where not all of the data necessarily has to be submitted for a decision to come. On the face of it, that sounds pretty optimistic. But then I'm hearing mixed messages as well.
What were the implications and consequences of the FDA denial of the Lycos, MAPS, MDMA petition? Yeah, I mean, it did cause this market correction. So, you know, companies were, their valuation dropped quite dramatically. And I think, you know, had that got through, that would have caused a general uplift, you know, rising tide for everyone in this space.
Were the reasons for it intelligible and justifiable? Some of them, and some of them weren't. Some of the data quality in terms of adverse events weren't fully reported, apparently. I think Lycos was the commercial face of maps. Mm-hmm. And MAPS, Multidisciplinary Association of Psychedelic Studies, headed up by Rick Doblin. And MAPS is, in a sense, an advocacy group for psychedelics generally.
Rick brings this incredible charisma, but it's not fundamentally, I think it's fair to say, an academic body, say, annexed to an obvious academic institution. it's not really pure scientists sort of running things. And I think that makes it a very easy target for this accusation of bias. I mean, the bias is pretty overt, really. And so they were very vulnerable in that regard.
And so some of the data quality issues in terms of all AEs being reported, I can sort of see how that could happened some of the some of the sites you know they weren't traditional clinical research sites some of the dosings happening in people's you know homes these are clinicians but still it wasn't very much wasn't the traditional model and so i can see how it went that way
I think the FDA made some errors in terms of their misunderstanding of psychedelic medicine and therapy. Ultimately, they're a regulatory body that approved drugs, drugs as medicines. And so they want to be able to look at the profile of the drug. And as this treatment was presented to them, It was a combination treatment.
Even in the framing of it, I think it was psychedelic-assisted therapy or MDMA-assisted therapy for post-traumatic stress disorder. So that's leaning emphasis on the therapy. And the FDA say, well, this isn't our remit. We're not a body to approve psychotherapy. So this is confusing to us. And I think that tripped things up quite considerably.
And I say compass pathways with psilocybin are playing it very differently. They're much more traditional. How do you think about the promise of psychedelics? Is it inextricably bound up with the role of a therapist or some sort of therapeutic context, or do you think the compounds and their utility are totally divorceable from context in that way? Certainly not. Yeah, I've
I've written a paper called Psychedelics and the Essential Importance of Context. So, you know, I'm very out there on this perspective that I do see it as fundamentally a combination treatment. So, you know, maps like us, how they presented it was right. It was transparent. And it's, in my view, the reality of this treatment. It's the secret source of this treatment is in that combination of
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Chapter 3: Why was the FDA denial of MDMA therapy significant?
What are you controlling? So it is more really what the staff do, the quality of their preparation ahead of a dosing session, the quality of the way they hold the space and provide compassionate support if necessary. needed during a dosing session because the support is typically quite hands-off. It's quite indirect. It's more like a holding rather than something directive.
There's often quite little talking going on, so it's not traditional psychotherapy. It's not traditional talking therapy in the session itself. But it is in the prep and it is in what we call the integration, which is the therapy, the psychological support that comes after the dosing session. It might come the next day. It might come the next week.
And plus maybe one or two sessions on top of that is how we tend to do it in the field. So we do control that quality of psychological support, both its amount and its quality. And we have a protocol to follow for that. We control music listening as a variable. We either have it on or off. With colleagues, we've referred to music as a hidden therapist because the sessions are so non-directive.
You ask the question, well, Is there any nudging, any coaxing going on here? The music can be quite an overwhelming experience. It gets enhanced in its emotionally evocative properties. And we control and manipulate the quality of the aesthetics.
So in what we call this enriched condition, we have an enriched condition with all these psychedelic therapy elements included, and we have an unenriched condition with them stripped out. So there's no music. The sessions are staffed, but really for basic safety monitoring, not for any kind of active emotional support unless there's an emergency. I mean, we're guided by Do No Harm, of course.
And yeah, we control the aesthetic. So in the enriched, there's lovely glowing lighting and printed screens of beautiful nature scenes. And then in the unenriched, it's a standard consulting room in a clinical research unit. All of this suggests that there's a fair amount to get right or wrong with respect to how one promotes people into the role of being a therapist.
I'm wondering about quality control there and screening and supervision and training and I'm thinking of one story I heard of someone who I think was in a group setting. I don't even know what the compound was. It might have been psilocybin. It might have been ayahuasca.
But somebody in the setting was feeling like they were remembering childhood sexual abuse, I think, some trauma from childhood that had not been conscious prior to taking the drug. But They were also uncertain as to whether it was a memory or whether they were just imagining it. And the therapist, you know, to my ear, who was in charge at that point, came in.
It was a heavily enriched context, but you might think it was enriched by this therapist's, you know, dogmatism or delusion because they seemed to be coming at this with a very strong sense of, you know, recovered memory being, you know, very much a real thing. I believe they told this subject that the body never lies or the body never forgets or something like that.
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