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Welcome to the Radical Responsibility Podcast. I'm doctor Fleet Mall
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and I'm excited to guide you on a journey of
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authentic transformation. In each episode, I'll bring you insights from
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leading experts to explore trauma recovery, mindfulness practices, positive psychology,
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and innovative breakthroughs in health, wellness and life optimization. This
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is a space for real conversations that inspire meaningful change,
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helping you find alignment with the person you are always
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meant to be. Let's get started. My name is doctor
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Fleet Mall, your co host for this session, and I'm
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really thrilled to be here today with none other than
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Rick Doblin. Welcome, doctor Doblin.
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Think that's a pleasure to be here with you today.
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Oh, it's really great to have you and been looking
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forward to this conversation. So maps under your direction has
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really been a pioneering force in psychoic research and the
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efforts to overturn what happened back in the seventies with
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the schedule of all the psychic medicines as schedule on
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drugs having no therapeutic or medical value, and your efforts
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led to the clinical studies on MDMA and psilocybin and others,
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and recently the FDA elected not to recommend rescheduling of
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MDMA at this time based on the advice of their
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or the recommendations from their advisory committee. So I'm curious
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about your thoughts on that. Where things stand now and
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given the complexities of the overall FDA approval process and
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dea rescheduling, you know, strategies for seems like it's something
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that's inevitable. But this is clearly that I would imagine
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a bit of a setback. So where are we and
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where do we go from here?
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Well, I do believe it's inevitable because I do believe
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that even the data that we have was considered by
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the ft advisory committee meaning to be in the advocate
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to demonstrate safety, your efficacy. They issued their report on
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June fourth. The Dutch State Committee on MBMA was the
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Dutch equivalent of the FDA committee, except for the fact
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that it had actual subject matter experts who knew more
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about psychedelics and psychedelic research than the advisory people did
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for the FDA. They spent about a year reviewing the
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data and they published a book length report about their findings,
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and they came to the opposite conclusion of the FDA
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Advisory Committee. They said that efficacy was proven, safety was proven,
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and since LEGOS had pulled out of Europe after supporting
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some early pilot studies in phase two to prepare therapists
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phase three, which LEGOS decided not to do, pulled out
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of Europe withdrew their application. The Dutch committee said that
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because efficacy and safety are proven, because there's such a
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major una medical need, there should be immediate implementation of
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what they called naturalistic studies, which is basically real world
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that evidence compassionate use where therapists can give MD get
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made PTSD patients, you do some measurements before and after,
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but there's no control group. So in that sense it's
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like real world evidence, and so that's what's being discussed
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to really set up now in the Netherlands. So I
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think that we need to look at how did two
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different bodies come to two completely different conclusions within two
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days of each other. And I think the answer is
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that the FT Advisory Committee really was composed of people
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that really didn't understand the data, the research. They were
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really much more influenced by media and public opinion, and
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for that Mico's had adopted a traditional approach, which they
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called the quiet period, which they wanted no interaction with media,
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no interaction with ousay agencies, not even blocking me from
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even responding to criticisms about the therapeutic approach in scientific journals.
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So I think it was basically a situation where we
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had people on the advisory committee who didn't really understand
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the science, were much more influenced by the media than
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they were by the briefing package that they got from
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the FDA, and who really didn't understand so much. So
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for example, and then I'll get to where do we
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go from here, which is really the key question. The
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advisory committee said that one big concern of theirs was
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this idea of functional and blinding. And you know, Lekos
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has hired David Hoff, who led the Spravado effort to
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make Spravado into a medicine for Johnson and Johnson for
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s kennemine spravado, and what he said in an interview
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in PSYCHEDELICALFA that in his experience, even schizophrenia studies are
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not really blinded because the drugs that are tested to
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have such a strong side effect profile that the researchers
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and the patients can tell whether they got the placeba
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or whether they got the active drug. Tom Lawfren, who
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was the former director of Psychiatry Products, said something similar
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that even in SSRI studies where you think it's a pill,
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it doesn't have like a psychedelic a fact, you need
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to take it for weeks or a month sometimes before
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it really changes one smood. That would be easy to blind.
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But he said again no, that the side effect profile
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of these drugs makes it so that a double blind
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is a theoretical approach, but in practice it fails more
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often than it succeeds. And we negotiated fully with the
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FDA in twenty seventeen, twenty sixteen of VER twenty ninth,
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twenty sixteen, as we got permission to go to Phase three.
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Because of the double blind and other issues, I decided
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to elect to go through a special protocol assessment process
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that took eight months, and we negotiated every aspect of
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the design with FDA, and we discussed intensively how to
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address functional unblinding, and the solution that the FDA chose
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was MDMA with inactive lacibo versus MDMA with full dose
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I mean therapy with inactiveacebo therapy with full dose MDMA.
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And the reason that my dissertation, which I got from
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the Kinny School Government Heart two thousand and one, focused
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a lot on the double blind issue, and I thought
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the solution was going to be therapy with low dose
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MDMA versus therapy with full dose. And the challenge was
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going to be, what's the dose that's high enough to
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start causing confusion. Microdose doesn't work because you don't really
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notice it. That's the definition of microdosing just has several effects.
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So what's the dose that's high enough to start saying
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to people, well, maybe this is a full dose, but
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not so high that it has so much therapeutic potential
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that you'll never be able to tell the difference between
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the two groups. And what we discovered in sixteen years
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of phase two studies starting in two thousand was that
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the lower doses did produce blinding, and I'm talking about
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twenty five milligrams thirty forty fifty were more likely to
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be confused with fuller dose, But to our surprise, they
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had an anti therapeutic effect, meaning they activated people, but
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they didn't reduce the fear enough and they made them uncomfortable.
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So by anti therapeutic, I mean they still got better
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because it's with the therapy, but they didn't get as much.
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Those people that got low dose MDMA did not make
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as much progress as those people that got therapy without
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any MDMA at all, with inactive placebo. So we went
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to the FDA and we said, hey, you know, we
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can give you blinding, but you're going to make it
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easier for us to find a difference between the two groups.
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The other thing we discovered in phase two, to our surprise,
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was that the that's tipping point you could say, to
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where it went from making people nervous to being very
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therapeutic was lower than we thought it was. Seventy five
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milligrams did great for people, and so in one study
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that we had veterans, firefighters, and police officers, it was
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thirty milligrams for one group, seventy five for another, and
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one twenty five milligram, and the seventy five milligram actually
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did better than the one twenty five. Now, when you randomize,
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not everything is equal, So there was more depression associated
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with the PTSD in the one twenty five group than
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in the seventy five group. That may have contributed to
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the difficulties of treating the people in the one twenty five,
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but in any case, seventy five was really very profoundly effective.
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So we went to the FDA and said, you know,
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we'll give you blinding, but the real quest question is
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if you can do this with therapy, why I bother
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out a drug. And then the other thing we said
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is that the safety profile is better understood and better
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characterized with inactive placebo, because if you have therapy with
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inactive placebo, whatever happens, you know is due to severe
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or monitor severe PTSD. In therapy. We had one woman
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try to kill herself twice in the study. Another woman
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had severe suicidal aviation checked herself into the hospital not
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to kill herself, and both were in the placebo group
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meaning MDMA with inactive placebo. If they had been in
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a group that had gotten twenty five or thirty or
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forty milligrams of MBMA, people would say, oh, maybe that
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was the MDMA made her uncomfortable. That's not background. Now
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when we talk about background factors for treating PTSD. The
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VA did a study, took him around six years, published
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it two years ago nine hundred and sixteen veterans comparing
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prolonged exposure with cognitive processing therapy, the two main non
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drug therapies used by the FDA to treat PTSD. Fifty
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percent of the people dropped out of the study because
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the therapy was retraumatizing. Half the people didn't even make
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it through the study. So that just shows you how
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difficult it is to normally treat people with PTSD with
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any of these normal standard therapies. So FDA had other
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reasons as well. Dutch committee, as I said, was the opposite.
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So where do we go from here?
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It just fell open up for just a minute a
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couple because I know there were a couple other objections
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raised by the TRAM.
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Yeah, I'd be glad to go through them.
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And we could just mention those briefly. The one that
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there was somewhere in the history of the clinical trials
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there was one incident of inappropriate behavior on the part
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of a sitter or a guide or a therapist, which
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happens in psychotherapy all the time. So not that it
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should and there's regulations do you have institutional repercussions, but
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it does happen, So isolating that is being a significant
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It seems like they gave way too much significance to that.
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Let me come out on that first switch totally right,
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because that happened in twenty sixteen. We started in two thousand.
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We've worked with around four hundred people. So the fact
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that a therapist would engage in sexually by definition and
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sexually usive relationship of a patient after the MDMA sessions
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were over one time out of hundreds and hundreds and
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hundreds eight years ago, yeah, that should never have happened.
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One is too many. But this idea that this is
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a rampant, you know, process and everybody who goes through
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therapy with MDMA is vulnerable, and that I'm you know,
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I was called the cult leader on par with scientology
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and nexting I mean, massive exaggerations. But my wife helped
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me to understand this a little bit better, and she
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said that a lot of women are harrassed, are raped,
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or you know, it's not an uncommon thing for a
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woman to encounter this. So when this was raised at
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the advisory committee in such a way that was so powerful,
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the women on the advisory committee meeting were probably reminded
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of some of their own experiences and that became more
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emotionally salient to them than the fact that it happened
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one time eight years ago out of like four hundred people.
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So I think it was completely overblown in the implications
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for the therapy. And at the same time, what about
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people to commit suicide from PTSD reward ratio.
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And as you said, one time of incidence of sexual
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abuse one time is too many, And this is the
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human realm, and these things happen. We try to prevent
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them as much as we can. But purely scientific based
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one out of that many eight years ago, it seems overlyweighted,
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to say the least.
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Well, let me just have it. In the Spravado studies
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for depression, some people committed suicide. We didn't have any
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of that. Not a single person in the MDMA group
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attempt at suicide.
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Maybe this is a minor out anonymous characterizer, but they
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pointed out that there was some they felt underreporting of
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not necessarily negative experiences, but the way preeople were characterized
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as having sort of positive trips so to speak, versus
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somewhat negative or something, And there was some they felt
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there was some underreporting of that. Am I characterizing that correctly?
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Yeah, this idea that people might pass through Now, let
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me just say ninety percent of the people had suicidal
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aviation and had serious suicidal ideation. Roughly a third had
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positive behavior, which means they attempted suicide or they bought
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a rope and thought about hanging them cells.
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We didn't do it prior to the study.
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I mean prior to the study. And once you look
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at this population, then this idea that sometimes people might
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go through a process where they're reliving some of their
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prior suicidal behaviors or ideations. And so the claim was, oh,
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every time that somebody felt suicidal, that was not reported
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as a adverse event. Now I don't believe that's the case.
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I think that there was a real good reporting of
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the adverse events. But the FDA, the letter that the
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FDA sent to licos to complete response letterlecos, I think
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has not made that public. But I think if they did,
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that would be helpful for people and they see whether
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FDA really decided that there was any of this under reporting.
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I don't think that's the case that the other party
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you said about the positive event adverse events. So the
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idea is that if you feel, you know is known
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as the love drug, and you know, people can feel
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self compassion, they can feel joy. A lot of people have,
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you know, particularly traumatized people have not felt joy for
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a long time. So what the FDA said is that
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all these moments of joy or ecstasy or you know,
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should have been recorded as a positive adverse event because
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it could lead to people, you know, taking MVMA outside
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of the therapeutic setting and becoming addicted to MBMA or
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addicted to cocaine. That's somebody at the advisory committee talked
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about how you're going to give people MBMA and before
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you know, if they're going to do cocaine, I mean
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at reads. So I think that it's true though that
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Lecos did not gather this kind of information. Again, it's
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like these are intermedia signals of something else. The something
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else is it is becoming dependent on MBMA. So there
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was no evidence that anybody became dependent on MBMA or
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you know, and there was evidence that people drink alcohol lass.
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You know, once you work through people's traumas, they have
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less of a need to ass escape and drug abuse.
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You know, there was a study in England with MDMA
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for alcohol use disorder, and most of the people in
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the study were running away from traumas and you help
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them work through it. They don't need so I think,
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actually MDMA systs the therapy will be helpful for addiction,
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is not going to create addiction. And yet FDA was like, oh,
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we don't have enough information on euphoria or other kind
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of positive adverse events that, like I was, probably should
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have gathered that, but they didn't.
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Well it's really interesting, I even help they're defining adverse effects,
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both positive and negative, because averse effects can be very
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much part of the therapeutic process.
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Yes, exactly, they're computer therapy. So when somebody goes through,
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there's suicidal ideations. So this is a different kind of
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a story, but this was someone that was, you know,
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going through MDMA therapy in an underground way. I heard
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this story and they were talking about and earlier. Actually
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this is somebody who had an LSD trip that was
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really difficult and then this is now forty years later,
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doing MDMA therapy to deal with the trauma of the
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LSD trip. And during the LSD trip, as the person
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was reliving it, they were talking about how, you know,
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they felt suicidal and that's why it was so problematic.
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And so when you're doing the therapy. You're revisiting these thoughts,
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but you're not like captive to them. It's like, oh,
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you know, yes, I was suicidal at that time. Does
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that feel right now? Did that feel right then? But
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you could look at it from the outside. Oh, now
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he's got suicidal thoughts and that's an adverse event, and
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now this guy's a danger of committing suicide again. He
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actually did try to kill himself during the LSD trip
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and later is trying to four years later, still trying
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to work through it. And it was kind of a
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breakthrough with the MDMA. Yeah, I think the FDA and
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others confused, what's the therapeutic process with adverse events.
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It's be interesting when the FDA looks at trials on
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psilocybin and other classic psychatic psilocybin or even LSD and others,
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because people as part of the therapytic process, people can
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have some really pretty difficult journeys revisiting even unconscious memories
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and traumas and so forth, and they can have extraordinary
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trans personal experiences that are part of the therapeutic back
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but might be considered you know, even beyond the uphoi
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as someone experiences an MDA, so it's kind of hard
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the way they're framing it, how you can almost ever
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get there.
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People at the advisor community said, oh, my god, can't
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trust the results. Forty percent of the people had done
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MDMA before they got into the study. Well, then they
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said they're biased. Now these people liked MDMA or else
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they wouldn't volunteered, they should have fewer side effects, and
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they should get better results because they're all biased. Well
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that's something to raise. However, in the debate of the
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discussions the formal Special Protocol assessment process, the FDA didn't say,
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don't enroll people with prior experience with MDMA. But in
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any case, those people that had prior experience with MDMA
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did not show greater benefits than those people that had
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never done MDMA, and those people that had done prior
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MDMA didn't show fewer side effects than the sixty percent.
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And I think the most important thing to say is
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that these people had done MDMA and they still had PTSD.
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The healing is not in the drug, it's in the
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relationship you have with the drug in a therapeutic context.
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So that was a big criticism. Oh, forty percent of
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your people at prior experience with MDMA, and theoretically we think,
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oh my god, they're biased and they're going to have
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better outcomes in your side effects. But when you look
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at the data, it wasn't that way at all, and
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you got that was this whole big confusion. And then
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the other a bunch of these people at one of
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them said, I've kind of voted against this in part
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because your studies were not diverse. Well, the second phase
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three study had fifty percent non white people. I mean,
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they totally didn't even understand what they were talking about.
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The other thing I should add is that, and this
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relates now back to the unblinding, is that the agreements
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we had with the FDA in twenty seventeen to conclude
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the Special Protocol assessment with a legal agreement letter where
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with people at the FDA who had left the agency afterwards,
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and so the new director of Psychiatry Products was deputy director,
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but she was not director when we made these agreements,
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and so we now have a changing of the guard
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to more conservative people. But the agreements that you make
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should not be with individuals, they should be based with
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the organization. These are agreements with FDA. The FDA changed
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the goal posts all of a sudden said, oh, this
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design that we chose to do inactive PLACEIBO, now we
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don't believe the results of it. It's completely inappropriate for
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them to do that. And we thoroughly discussed functional and blinding,
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and what the FDA said was that there's two main
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ways to deal with this. When there is functional on blinding,
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which there is, as I said, in many studies, but
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also in psychedelics, in cannabis, and also all psychotherapy studies
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are not blinded. You know, you can't blind some mean
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what kind of psychotherapy they're receiving, but the idea that
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people were somehow or other, you know, biased. The FDA
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said that random assignment is the first thing. You want
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everybody to similarly motivated, So that's easy to do. But
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then the other thing that they said is that you
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want independent raiders to evaluate the outcomes. The outcomes should
357
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not be evaluated by the research team or by the therapists.
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And so we had a very robust system of independent raiders,
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over twenty raiders, mostly trained by the Boston VA, with
360
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monthly interrator reliability tests where they'd all watch a videotape
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of someone going through a PTSDD interview for the clinician
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administered PTSD scale. So we had independent raiders that were
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blinded of the condition and we had random assignment and
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so those Now the other thing to say, which somehow
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never got discussed, is that twenty five percent of the
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people who got placebo either thought they had MDMA or
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were unsure. So that's not so bad blinding. Twenty five
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percent of the people who got the placebo couldn't tell
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or thought they had MDMA because they were in a
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situation of work difficult issues. They were supported with music.
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Now it's not the other way around. So it's like
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ninety five percent of the people that got MDMA knew
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they got MDMA. But when you look at the placebo people,
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now the other criticism you could make is, oh, these
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therapists are the blinding doesn't work, and the therapists are
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now biased because now they know who gets MDMA and
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who doesn't, and they're gonna try harder with the people
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that get MDMA and they're not going to try so
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hard with the PLAICCBO people. Well, first off, that's totally
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not true. We have videotapes of all these therapy sessions.
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We've had adherence raiders. That's not true. But the other
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thing is, if you look at the second phase three study,
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unbelievableth forty six point seven percent in the placebo group
384
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no longer had PTSD. That's better than prolonged exposure cognitive processing.
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There's an incredibly low dropout rate. And so the results
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in our control group that got therapy with inact of placebo,
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where seventy five percent knew they had inactive placebo and
388
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twenty five percent weren't sure. I thought it was MDMA,
389
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the results are outstanding. So there's no evidence whatsoever that
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this blinding not working caused therapists to be biased in
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their effort. And there's no good solution. That's the other
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big problem is what's a better approach. So we told
393
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the FDA, you want blinding, you're going to make our
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job easier, we'll give it to you. And they said,
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no therapy with the inactive pacible. Let's make your job
396
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harder to show a difference between the two groups. So
397
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for this current crop of people at the FDA to backtrack,
398
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it's really outrageous, I think, and you know none of that.
399
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But it's expensive, it's not fair, it's not good to patience.
400
00:21:32.359 --> 00:21:34.599
And I think that the you know, this is something
401
00:21:34.599 --> 00:21:36.559
that people are not aware of, but the FDA is
402
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actually considering a proposal to stop voting at the advisory
403
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committee level. They want to keep the advisory committee to
404
00:21:43.920 --> 00:21:46.799
get give advice, but the voting makes it seem like
405
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they have more credibility and more power than they really do.
406
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And the lack of knowledge in this group of people
407
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at the advisory committee was astonishing. In fact, the most
408
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outrageous was this one woman, supposedly the patient representative, said, Hey,
409
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why do we even need new therapies for PTSD? We
410
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have really good evidence based therapies for PTSD and they
411
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work great, and they're so much cheaper than this than
412
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they act faster, I mean, unbelievable. I mean, there's a
413
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million veterans receiving disability for PTSD from the VA. You know,
414
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we included people in our studies that had tried therapies,
415
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had tried medications. This idea from the patient representative that
416
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we don't need new treatments for PTSD is so out
417
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of touch. But those were the people that were asked
418
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by FDA to review, and they really were out of
419
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their depth.
420
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Yeah, that was one of the most shocking things was
421
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the composition of the committee itself. So in light of
422
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where do we go from here, I don't know if
423
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there are ongoing discussions between like Closet and the FDA
424
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on how to go forward. I'm curious whether some kind
425
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of open placebo trial would be one possibility. Up Basically,
426
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people know they're getting a placebo and they know they're
427
00:22:57.039 --> 00:23:01.519
not getting a placebyl and so it makes it process transparent,
428
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and then you're looking at the data as similar to
429
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some of the effects you saw in there that people
430
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who didn't realize they got the placeble, and some of
431
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those people who did realize they got placeble still had
432
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therapeutic effects in the situation. So I'm not sure whether
433
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that could work in this stuff, but some way around
434
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so it seems like the way they're presenting this blating
435
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issue almost is saying you can't get there from here.
436
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Well, what the FDA. You know, the evidence needs to
437
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be presented to the FDA, the data needs to present
438
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the FDA. So LICOS is engaging in the next couple
439
00:23:31.039 --> 00:23:35.319
months with discussions about FDA. There's been some leakage about
440
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what was in this letter published in Psychedelic Alpha, a
441
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newsletter for investors in psychedelgics, and one of the things
442
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that they said was that Licos is saying that, oh,
443
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we don't understand this therapy, so don't use it. Don't
444
00:23:48.880 --> 00:23:51.839
use the therapy that got these incredible results with MDMA,
445
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but use MDMA with the evidence based therapy like prolonged
446
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exposure or something like that. Then they said, not in
447
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the direction you're saying, but they would want like an
448
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active placebo of something. So they're considering lodos MDMA, which
449
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we considered explored for sixteen years in abandon but they
450
00:24:08.640 --> 00:24:11.160
may go back to that, or they may go to
451
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quote psychological support, which is MDMA without therapy at all.
452
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So the concern I have is if they go in
453
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that direction based on kind of pressure from FDA or
454
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suggestions or requirements from FDA. If you get it approved,
455
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what's going to happen with insurance companies. They'll pay for
456
00:24:28.359 --> 00:24:29.960
the drug, but they're not going to pay for more
457
00:24:30.000 --> 00:24:32.759
therapy than was used in the phase three studies. Does
458
00:24:32.839 --> 00:24:35.319
Lecos care about that? I don't know. I think they
459
00:24:35.359 --> 00:24:39.000
care about selling the drug and what's best for patients
460
00:24:39.079 --> 00:24:42.440
is a separate thing. So I'm worried that the design
461
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of the new Phase three study will be to minimize
462
00:24:46.400 --> 00:24:50.680
the role of therapy to use psychological support. I'm fine
463
00:24:50.720 --> 00:24:53.359
if they want to use an active I mean a lotos.
464
00:24:53.480 --> 00:24:56.039
MDMA is a placebo. You know, all the work that's
465
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been done with psilocybin, a lot of it has been
466
00:24:58.680 --> 00:25:01.640
using niasin as an active placebo. Nice and gives you
467
00:25:01.720 --> 00:25:04.480
to a flush and stuff, but it's not psychedelican anyway.
468
00:25:04.519 --> 00:25:06.799
Nobody is fooled by that. You know, if you give
469
00:25:06.799 --> 00:25:10.039
people a tranquilizer, the therapists are not going to be fooled.
470
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Then the people are not going to be thinking, oh,
471
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this is MDMA. And if you give a stimulant like amphetamine,
472
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which doesn't have the heart opening properties of MDMA but
473
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has some in that direction, you know, I think it'll
474
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lack more like lotos. MDMA could be compromising of the therapy.
475
00:25:23.839 --> 00:25:25.839
People could still get better. So I don't know that
476
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there's a better solution, but the FDA is going to say, oh,
477
00:25:28.759 --> 00:25:31.599
do something different, and LIKECOS will say, you know, tell
478
00:25:31.680 --> 00:25:32.119
us what to.
479
00:25:32.039 --> 00:25:35.319
Be Inevitably there will be another pace free trial.
480
00:25:35.519 --> 00:25:38.039
You think, yeah, see, oh for sure, not only were
481
00:25:38.119 --> 00:25:41.240
they well, First off, the FDA approaches essential. We need
482
00:25:41.279 --> 00:25:43.960
to go through the FDA. It's critical they get insureman's coverage,
483
00:25:44.000 --> 00:25:46.160
even if it's just for the drug. And at the
484
00:25:46.200 --> 00:25:49.240
same time, I think lycos will succeed that they've got
485
00:25:49.480 --> 00:25:51.839
I think this delay will be maybe three years. I
486
00:25:51.880 --> 00:25:55.160
don't know how long it'll actually be, but I Thinklecos
487
00:25:55.200 --> 00:25:59.200
will in the end succeed with something. And the other
488
00:25:59.319 --> 00:26:01.720
point is you don't need outstanding results like we had
489
00:26:01.720 --> 00:26:05.319
to succeed. You just need statistical significance. You know, whether
490
00:26:05.359 --> 00:26:09.319
insurance companies will pay for stuff if it's marginally effective
491
00:26:09.480 --> 00:26:12.720
is another question. The other issue about durability, which we
492
00:26:12.799 --> 00:26:16.640
do have very good durability. Not we but LIKECOS or MAPS,
493
00:26:16.680 --> 00:26:21.599
the PTSD patients for really good variability durability, I mean,
494
00:26:21.880 --> 00:26:24.960
and that's key for insurance coverage because it's labor intensive
495
00:26:24.960 --> 00:26:27.960
at the beginning and if it fades over time, they
496
00:26:27.960 --> 00:26:29.799
won't pay for it, but if it's durable they will.
497
00:26:30.319 --> 00:26:33.039
So I do think that Locos will succeed with something
498
00:26:33.160 --> 00:26:36.279
in about three years. And what MAPS is trying to
499
00:26:36.319 --> 00:26:39.960
do is work on creating a nonprofit in Europe to
500
00:26:40.000 --> 00:26:42.759
see if we can raise money from donors. We might
501
00:26:42.839 --> 00:26:45.559
need up to one hundred million or something, but can
502
00:26:45.599 --> 00:26:48.759
we do that and that would permit us to develop
503
00:26:48.880 --> 00:26:54.079
MDMA assistant therapy in Europe with open science, no patents,
504
00:26:54.119 --> 00:26:57.160
and turn it immediately into a generic That's something It's
505
00:26:57.200 --> 00:26:59.319
a long shot, but that's what MAPPS will be working
506
00:26:59.319 --> 00:27:00.519
with others in your to do.
507
00:27:00.920 --> 00:27:04.720
I'm curious as we know, in Australia, the government recently
508
00:27:04.839 --> 00:27:08.599
this year approved both the MDAMA and psilocybin for prescribed
509
00:27:08.640 --> 00:27:13.960
therapeuticcuse and it's currently being used by therapists, psychiatrists, psychotherapists
510
00:27:13.960 --> 00:27:16.720
to go through some kind of initial approval process and
511
00:27:16.720 --> 00:27:19.240
then they're able to use it with their patients. And
512
00:27:19.319 --> 00:27:22.079
I understand it was a bit of a different process there.
513
00:27:22.599 --> 00:27:25.240
The drug actually hasn't been registered what you would call
514
00:27:25.400 --> 00:27:29.400
registered in Australia, which would require an FDA type clinical
515
00:27:29.480 --> 00:27:32.200
trial process, but rather it's been approved by some kind
516
00:27:32.240 --> 00:27:35.119
of governmental process that am I saying was driven as
517
00:27:35.200 --> 00:27:39.480
much by consumer demand and tens of thousands of patient
518
00:27:39.559 --> 00:27:42.039
testimonials as much by that as a science.
519
00:27:42.079 --> 00:27:42.240
Now.
520
00:27:42.240 --> 00:27:45.000
They certainly did reference to clinical trials going on worldwide,
521
00:27:45.039 --> 00:27:47.440
but it seems like it was a different process altogether,
522
00:27:48.079 --> 00:27:50.599
and I'm wondering whether there's anything to learn from that
523
00:27:50.720 --> 00:27:53.079
or are there any other mechanisms in the US outside
524
00:27:53.119 --> 00:27:57.599
of complete legalization or during criminalization that could move the
525
00:27:57.599 --> 00:27:58.440
ball down the field.
526
00:27:59.119 --> 00:28:05.240
Yeah. Well, there's program called expanded access, which is compassionate use. Basically,
527
00:28:05.319 --> 00:28:07.839
LECOS did have an expanded access protocol where you get
528
00:28:07.880 --> 00:28:11.359
MDMA similar in the Phase three design, but there's no
529
00:28:11.480 --> 00:28:14.599
control group and the data is only for safety, not
530
00:28:14.720 --> 00:28:19.680
for efficacy because there's no control group, ANDCOS, for financial
531
00:28:19.680 --> 00:28:21.759
reasons is shut that down. It takes a bit of
532
00:28:21.799 --> 00:28:25.079
time to manage that staff, time and money, so that's
533
00:28:25.119 --> 00:28:27.519
not going to happen. In Australia. It is more like
534
00:28:27.559 --> 00:28:33.279
this compassionate access. You know, Canada they call it special protocol. Yes,
535
00:28:33.359 --> 00:28:37.960
so there's compassionate using Canada and Australia. It's patient by patient.
536
00:28:38.079 --> 00:28:42.079
It is compassionate use. In the US. There the big hope,
537
00:28:42.079 --> 00:28:45.319
and this might take six months or so to resolve,
538
00:28:45.640 --> 00:28:48.640
is what's called right to try. So there's a bunch
539
00:28:48.680 --> 00:28:52.640
of laws in thirty nine states I think that say
540
00:28:52.640 --> 00:28:55.880
that patients have a right to try drugs that are
541
00:28:55.960 --> 00:28:59.480
being developed by pharma if they've tried other medications and
542
00:28:59.519 --> 00:29:02.680
they haven't worked, and there's an experimental drug, then they
543
00:29:02.680 --> 00:29:04.680
should have our right to try, meaning that they can
544
00:29:04.799 --> 00:29:07.880
contact the pharma company and see if they will provide
545
00:29:07.920 --> 00:29:10.640
access to the drug outside of the FDA, not for
546
00:29:10.720 --> 00:29:14.039
research at all, but just as again as a compassionate use. Now,
547
00:29:14.519 --> 00:29:19.720
right to try is prohibited right now from being applied
548
00:29:19.759 --> 00:29:23.960
to controlled substances, meaning scheduled drugs. And there was a
549
00:29:24.039 --> 00:29:27.920
lawsuit about two weeks ago against the DEA by Catherine
550
00:29:27.960 --> 00:29:31.960
Tucker and the others to try to expand right to
551
00:29:32.079 --> 00:29:36.799
try to control substances, and the outcome of that lawsuit
552
00:29:36.880 --> 00:29:39.160
will be known in about six months or so, so
553
00:29:39.240 --> 00:29:45.160
then so promising opportunity if the lawsuit works. Other than that,
554
00:29:45.920 --> 00:29:48.759
you know, there's state level reform. So for example, in November,
555
00:29:48.880 --> 00:29:51.559
just less than two months from now, there's going to
556
00:29:51.559 --> 00:29:56.119
be a ballot initiative in Massachusetts to legalize plant psychedelics,
557
00:29:56.160 --> 00:29:59.559
similar to what passed in Colorado, and expanding on what
558
00:29:59.640 --> 00:30:03.119
passed before in the Oakland psilocybin initiative, which was just
559
00:30:03.160 --> 00:30:06.759
for psilocybin. Now, the problem, from my point of view
560
00:30:06.799 --> 00:30:10.119
is that people have this romantic attachment to plants. But
561
00:30:10.200 --> 00:30:12.920
when you add synthetics like MDMA or psilocybin and you
562
00:30:12.960 --> 00:30:15.279
do the polling, then people don't vote for it, not enough.
563
00:30:15.880 --> 00:30:21.279
So access to MDMA through the state level reforms is
564
00:30:21.400 --> 00:30:25.279
not likely to happen for quite some time because people
565
00:30:25.319 --> 00:30:29.839
again are focused on plants, psychedelics and not synthetics. So
566
00:30:30.039 --> 00:30:33.599
right now, there is no place in the entire world
567
00:30:33.799 --> 00:30:39.799
where people can legally access MDMA outside of a therapeutic protocol. Now,
568
00:30:39.839 --> 00:30:42.319
if you want to go to psilocybin experiences, you can
569
00:30:42.359 --> 00:30:44.720
go to Jamaica, you can go to Costa Rica, you
570
00:30:44.759 --> 00:30:47.240
can go to the Netherlands, you can go to Oregon,
571
00:30:47.279 --> 00:30:49.079
you can go to Colorado. You may be able to
572
00:30:49.160 --> 00:30:52.359
go to the Massachusetts eventually, but there's no place for
573
00:30:52.559 --> 00:30:57.759
MDMA where it's legal without being in a protocol. Unfortunately.
574
00:30:58.920 --> 00:31:01.119
I'm warning about the role of MAPS and kind of
575
00:31:01.160 --> 00:31:04.519
advocacy in Australia. I think there was a you mentioned
576
00:31:04.519 --> 00:31:07.279
this blind period that the traditional blind period during the
577
00:31:07.319 --> 00:31:12.000
FDA process period I'm sorry, quiet period, right, quiet.
578
00:31:11.799 --> 00:31:14.640
Disaster, and not only did lecos quiet, but then they
579
00:31:14.720 --> 00:31:19.480
blocked MAPS and ME from speaking, which was very damaging. Yeah.
580
00:31:19.559 --> 00:31:22.000
So I'm wondering if you have been allowed to have
581
00:31:22.079 --> 00:31:25.319
stronger advocacy that might have because you, as you said,
582
00:31:25.359 --> 00:31:27.599
you think that of Isiac Committee was strongly influenced by
583
00:31:27.640 --> 00:31:30.799
public opinion or different political views, and so public opinion,
584
00:31:31.079 --> 00:31:32.759
and there does seem to be a sea change of
585
00:31:32.799 --> 00:31:36.759
political or public opinion in this country around psychalics and
586
00:31:36.759 --> 00:31:39.480
psychoic medicines, and it'spertally when you hear from the veteran
587
00:31:39.519 --> 00:31:43.680
community and so forth. So I'm wondering if about maps
588
00:31:43.720 --> 00:31:46.920
strategies and with other organizations within the psychaic space in
589
00:31:47.000 --> 00:31:51.559
terms of advocacy, that could marshal enough public opinion and
590
00:31:51.799 --> 00:31:54.400
consumer demand to say, look, you know, there's plenty of
591
00:31:54.440 --> 00:31:56.920
evidence that these things are helping people and this is
592
00:31:56.920 --> 00:32:00.440
something we want. I mean, similarly, you know it's reruly
593
00:32:00.480 --> 00:32:04.480
citizen demand has opened up the whole field of alternative
594
00:32:04.519 --> 00:32:06.880
medicine and even supplements all the rest. At one point,
595
00:32:06.960 --> 00:32:10.319
the FDA and the medical establishment really tried to shut
596
00:32:10.400 --> 00:32:13.559
down the whole world of supplements and all that. At
597
00:32:13.559 --> 00:32:16.759
one point, I think studies showed that citizens were spending
598
00:32:16.799 --> 00:32:20.240
sixty five seventy percent of their medical dollars on alternative medicine,
599
00:32:20.240 --> 00:32:22.799
and I'm sure that freaked out the establishment, but it
600
00:32:22.839 --> 00:32:25.920
really was consumer demand that has really changed that landscape.
601
00:32:25.960 --> 00:32:27.920
So I'm just curious about that whole process.
602
00:32:28.400 --> 00:32:30.000
Yeah, I don't think any of that's going to work
603
00:32:30.039 --> 00:32:33.880
for synthetics like MDMA. Unfortunately, how do you get that?
604
00:32:33.960 --> 00:32:37.200
You know, it gets mediated through state level reforms of
605
00:32:37.359 --> 00:32:41.720
some way, drug decriminalization, you know, or just you know,
606
00:32:42.119 --> 00:32:44.640
there was nineteen s senators and sixty one members of
607
00:32:44.640 --> 00:32:46.720
Congress that sent a letter to the FDA and to
608
00:32:46.839 --> 00:32:51.359
the President Biden saying approve MDMA, But FDA doesn't want
609
00:32:51.400 --> 00:32:54.240
to be swayed by politics, and LYCOS didn't do enough
610
00:32:54.279 --> 00:32:56.720
to respond to the issues that were raised at the
611
00:32:56.759 --> 00:32:57.839
Advisory committee meeting.
612
00:32:59.079 --> 00:33:01.400
Well, it's interesting. MDMA certainly has a history of being
613
00:33:01.480 --> 00:33:04.480
used recreationally, as we all know, but in many ways
614
00:33:04.559 --> 00:33:07.359
it's it could be considered a little more benevolent and
615
00:33:07.440 --> 00:33:10.000
less risky than many of the more powerful psychedelics that
616
00:33:10.279 --> 00:33:11.640
even the plant derived ones.
617
00:33:12.000 --> 00:33:12.920
Yeah, oh very much.
618
00:33:12.920 --> 00:33:13.000
So.
619
00:33:13.160 --> 00:33:16.799
Yeah, people don't have panic reactions as much, you know,
620
00:33:16.880 --> 00:33:19.880
to MDMA as they do for psilocybin. There are people
621
00:33:19.880 --> 00:33:22.559
that have committed murders or committed suicide under the influence
622
00:33:22.559 --> 00:33:24.839
of psilocybin. It's really rare, but that kind of thing
623
00:33:24.839 --> 00:33:28.000
you don't see under MBMA. It's more gentle, filled with
624
00:33:28.000 --> 00:33:32.880
self compassion. So I think that the concerns there are less.
625
00:33:33.160 --> 00:33:35.920
I think it should be legalized and the consequences will
626
00:33:35.920 --> 00:33:39.599
be mostly beneficial with some negative outcomes, but I think
627
00:33:39.640 --> 00:33:41.920
the negative outcomes will be way less than the negative
628
00:33:41.960 --> 00:33:44.880
outcomes from the drug war. I mean, people have died
629
00:33:44.880 --> 00:33:49.200
from ecstasy contaminated with fentanyl. That's correctly related to the
630
00:33:49.279 --> 00:33:52.839
drug war. That's not problems with ecstasy. That's problems or MBMA.
631
00:33:52.960 --> 00:33:55.440
That's problems with underground market its.
632
00:33:55.880 --> 00:33:59.279
Yeah, that's a whole other conversation. The collateral damage of
633
00:33:59.319 --> 00:34:03.559
criminalization in the drug war seems so nonsensical. You mentioned
634
00:34:03.559 --> 00:34:07.319
before the possible what you're doing in your possible average
635
00:34:07.359 --> 00:34:09.639
you could be making in Europe, and I'm wondering curious
636
00:34:09.639 --> 00:34:12.199
about kind of maps. I know you do think globally
637
00:34:12.320 --> 00:34:14.719
in terms of world this is and you know, even
638
00:34:14.719 --> 00:34:19.519
for humanitarian reasons that how opening up both the therapeutic
639
00:34:19.679 --> 00:34:23.519
use of psychedelics and maybe the more well educated sort
640
00:34:23.519 --> 00:34:27.639
of personal growth use and safe and well educated personal
641
00:34:27.639 --> 00:34:31.360
growth while shifting our views around this could really address
642
00:34:31.480 --> 00:34:35.440
some of the really pressing humanitarian issues we have globally
643
00:34:35.679 --> 00:34:38.000
from the effects of all kinds of trauma and as
644
00:34:38.000 --> 00:34:40.079
well as the mental health crisis and all kinds of
645
00:34:40.159 --> 00:34:41.840
things that are going on not just in the US
646
00:34:41.880 --> 00:34:44.719
but globally. And I'm curious about maps involvement with that
647
00:34:44.760 --> 00:34:47.519
and some of your ideas around that. What is transformation
648
00:34:47.760 --> 00:34:52.239
isn't just about thinking differently but feeling differently. Science shows
649
00:34:52.280 --> 00:34:54.920
us that true change happens when we align not just
650
00:34:55.000 --> 00:34:58.679
our minds, but also the neural networks in our hearts
651
00:34:58.719 --> 00:35:02.039
and guts. This heart mind connection is the key to
652
00:35:02.119 --> 00:35:06.519
deeper healing, resilience, and expanded awareness. That's why I created
653
00:35:06.559 --> 00:35:10.159
the Heart Mind All access, membership and community, a space
654
00:35:10.239 --> 00:35:14.480
designed to help you rewire your nervous system, cultivate heart intelligence,
655
00:35:14.760 --> 00:35:18.320
and live with greater clarity and purpose. With over one
656
00:35:18.400 --> 00:35:23.880
thousand hours of transformational teachings specifically curated to meet your needs,
657
00:35:24.320 --> 00:35:29.599
You'll learn from world renowned meditation teachers, neuroscientists, and experts
658
00:35:29.599 --> 00:35:34.039
in neuroplasticity, all sharing powerful tools to help you shift
659
00:35:34.039 --> 00:35:38.840
your mindset and heartset, regulate your emotions, and unlock your
660
00:35:38.880 --> 00:35:43.639
full potential. You'll also gain unlimited access to every summit
661
00:35:43.679 --> 00:35:47.000
and course we've ever produced, a Treasure Trouble Wisdom worth
662
00:35:47.039 --> 00:35:50.760
over ten thousand dollars in growing, plus live gatherings, and
663
00:35:50.800 --> 00:35:54.719
an inspiring global community to support your journey. If you're
664
00:35:54.760 --> 00:35:57.480
ready to step into a more heart centered, connected and
665
00:35:57.519 --> 00:36:00.559
conscious life, I invite you to join us. Clip the
666
00:36:00.639 --> 00:36:03.239
link to learn more and start your journey today.
667
00:36:04.320 --> 00:36:06.719
Wow. Thank you for asking that, because that's really a
668
00:36:06.760 --> 00:36:09.280
lot of the areas that I'm working on right now,
669
00:36:09.400 --> 00:36:12.400
which is I'll just say from an advocacy point of view, though,
670
00:36:12.440 --> 00:36:15.039
just to mention that in June sixteenth to twentieth of
671
00:36:15.280 --> 00:36:17.920
twenty twenty five, we're going to have the world's largest
672
00:36:17.960 --> 00:36:22.119
conference on psychedelacs ever in Denver. We had Psychedelic Science
673
00:36:22.159 --> 00:36:26.440
twenty twenty three that was in Denver twelve four hundred people,
674
00:36:26.880 --> 00:36:30.360
so we anticipate even more people for this upcoming conference
675
00:36:30.400 --> 00:36:33.199
in June in Denver to bring the community together, to
676
00:36:33.480 --> 00:36:36.320
share ideas and things like that, and to bring people
677
00:36:36.360 --> 00:36:38.519
from all over the world. And we're talking about potentially
678
00:36:38.559 --> 00:36:41.480
a track from the global psychedelic societies, because there are
679
00:36:41.480 --> 00:36:44.800
psychedelic societies all over the world. Now, as far as
680
00:36:44.800 --> 00:36:48.760
our humanitarian projects, I saw something some information not too
681
00:36:48.760 --> 00:36:51.360
long ago that talked about the lag between drugs that
682
00:36:51.400 --> 00:36:54.800
are approved in it by FDA or by EMA and
683
00:36:54.880 --> 00:36:57.840
the time these drugs reached the Third World, and often
684
00:36:57.880 --> 00:37:01.840
it's well over a decade or more, and so there
685
00:37:01.880 --> 00:37:07.039
is massive amounts of trauma, especially in poorer countries. You know,
686
00:37:07.039 --> 00:37:09.119
there's an estimate that there could be a billion climate
687
00:37:09.159 --> 00:37:12.920
refugees by twenty fifty and these will all be traumatized
688
00:37:12.920 --> 00:37:15.719
people who will be destabilizing societies. They'll be trauma all
689
00:37:15.760 --> 00:37:18.159
over the place. So I think it's really important that
690
00:37:18.159 --> 00:37:19.880
we think globally. I think one of the things that
691
00:37:19.960 --> 00:37:22.559
Lecos ignored at its peril was this idea that it's
692
00:37:22.599 --> 00:37:25.519
only about the data, which means that they ignored the culture,
693
00:37:25.519 --> 00:37:27.519
and it's only about the US, which means they shut
694
00:37:27.519 --> 00:37:30.840
down Europe. So we have a series of small pilot
695
00:37:30.960 --> 00:37:34.480
studies that we're trying to start, and MAPS is also
696
00:37:34.639 --> 00:37:39.360
doing international trainings, So we are recently had trainings in
697
00:37:39.400 --> 00:37:43.599
Bosni and Sarajevo. We've had trainings in Iceland. So the
698
00:37:43.639 --> 00:37:48.920
first example of a program humanitarian projects is in Somaliland
699
00:37:49.239 --> 00:37:53.639
in Africa, and there's Dale Armstrong's a US psychiatrist that
700
00:37:53.880 --> 00:37:57.679
sort of adopted this area of Somaliland, building a medical
701
00:37:57.679 --> 00:38:01.159
clinic things like that. And so we trained a bunch
702
00:38:01.199 --> 00:38:03.840
of Smiley Land therapists and then they got permission from
703
00:38:03.840 --> 00:38:07.320
their government to import two point one grams of MDMA
704
00:38:07.480 --> 00:38:10.719
for a protocol to give MDMA to therapist as part of
705
00:38:10.760 --> 00:38:13.559
their training, because these are people that have no psychedelic history,
706
00:38:13.960 --> 00:38:17.039
and it was just amazing how much mdmay helped them
707
00:38:17.159 --> 00:38:21.639
personally and how much this experience prepared them for working
708
00:38:21.639 --> 00:38:24.760
with PTSD patients. And now that's in the process of
709
00:38:24.840 --> 00:38:28.639
designing the next study with some body land people with PTSD.
710
00:38:29.079 --> 00:38:31.760
In Bosnia, we're working with the team there that want
711
00:38:31.880 --> 00:38:34.159
to we've trained them. They wanted to do a study
712
00:38:34.199 --> 00:38:38.079
with survivors of the shred Brenica massacre about thirty years
713
00:38:38.079 --> 00:38:41.000
ago where an eighty six hundred or so men and
714
00:38:41.119 --> 00:38:43.639
boys Muslim men and boys were all murdered. So this
715
00:38:43.679 --> 00:38:47.400
would be for women survivors of that. There's a project
716
00:38:47.440 --> 00:38:50.599
in Denmark that we're working to start to help the
717
00:38:50.639 --> 00:38:54.079
people start there. That would be with Syrian refugees in
718
00:38:54.199 --> 00:38:58.920
Denmark second generation, the ones that speak English, less religious
719
00:38:58.960 --> 00:39:01.360
than their parents and are believing that they're going to
720
00:39:01.360 --> 00:39:04.599
stay in Denmark. We're talking about a project that we've
721
00:39:04.599 --> 00:39:07.880
been approached in Rwanda. We haven't had any resources for
722
00:39:07.960 --> 00:39:11.760
that yet. We're talking about training in Ukraine and to
723
00:39:11.840 --> 00:39:15.280
try to bring MDMA to Ukraine and their terrible time
724
00:39:15.360 --> 00:39:18.920
of massive culture wide trauma. And so if we can
725
00:39:18.960 --> 00:39:22.440
do these and maybe one or two other humanitarian projects,
726
00:39:22.920 --> 00:39:25.920
the goal is to do them, to train the trainers,
727
00:39:26.079 --> 00:39:29.079
meaning to help the therapists they learn how to train
728
00:39:29.079 --> 00:39:31.039
another therapist, and then to go for like one hundred
729
00:39:31.039 --> 00:39:32.719
million dollar grant a year and a half or two
730
00:39:32.760 --> 00:39:36.400
years or so from now to really globalize access in
731
00:39:36.480 --> 00:39:38.880
humanitary ways, because these are things the pharma company is
732
00:39:38.920 --> 00:39:41.039
not going to do, and yet the need is great.
733
00:39:41.119 --> 00:39:44.159
And people may have heard about the study with octopuses
734
00:39:44.320 --> 00:39:47.760
where Gould, Dolan and hero scientists at Hopkins and now
735
00:39:47.800 --> 00:39:51.880
at Berkeley, but she gave MDMA to octopuses maps provided
736
00:39:51.920 --> 00:39:56.440
the MBMA, and octopuses became pro social. They're solitary creatures,
737
00:39:56.920 --> 00:39:58.920
but under the influence of MDMA they wanted to hang
738
00:39:58.920 --> 00:40:03.920
out with other octopuses. So it gets pro social, evolutionary, conserved,
739
00:40:04.000 --> 00:40:07.239
and pre verbal. So I think that what we're going
740
00:40:07.320 --> 00:40:09.519
to find is that MDMA is going to work cross
741
00:40:09.519 --> 00:40:12.239
culturally in all these different contexts. We'll have to figure
742
00:40:12.239 --> 00:40:16.119
out what's the therapeutic context things like that. But that
743
00:40:16.119 --> 00:40:17.800
I think is one of the more exciting things that
744
00:40:17.840 --> 00:40:19.480
MAPS is going to be working on, is to really
745
00:40:19.480 --> 00:40:24.400
to globalize access to highly traumatized populations that maybe don't
746
00:40:24.400 --> 00:40:27.559
have a lot of resources. There's something else that MAPS
747
00:40:27.679 --> 00:40:29.800
is going to do with this. We're trying to start
748
00:40:29.840 --> 00:40:34.199
this nonprofit in Europe that would end up trying to say,
749
00:40:34.280 --> 00:40:38.159
let's follow the Dutch position naturalistic studies and then negotiate
750
00:40:38.199 --> 00:40:40.760
it with them A and MHR in England if they
751
00:40:40.760 --> 00:40:45.400
would accept people treated in naturalistic studies as equivalent to
752
00:40:45.559 --> 00:40:48.800
a Phase three study. Then there's something else that's really
753
00:40:48.840 --> 00:40:52.639
interesting for me, which is MDMA for couples therapy. So
754
00:40:52.880 --> 00:40:55.840
couple's therapy is not a disorder. People think, well, the
755
00:40:55.920 --> 00:40:58.400
FDA has never approved a drug and psychiatry for something
756
00:40:58.440 --> 00:41:01.000
that's not a clinical disorder, but there's nothing in the
757
00:41:01.079 --> 00:41:03.880
law that prevents them from doing that. And the advantage
758
00:41:03.880 --> 00:41:07.039
of FDA approval is that then you have insurance coverage potentially.
759
00:41:07.119 --> 00:41:09.840
So we're going to start a study in California with
760
00:41:10.000 --> 00:41:13.559
MDMA for couple's therapy. That's going to be really exciting.
761
00:41:13.639 --> 00:41:16.519
Then the other thing is MAPS is doing twelve point
762
00:41:16.599 --> 00:41:19.119
nine We've got a twelve point nine million dollar grant
763
00:41:19.159 --> 00:41:22.159
from the state of Michigan for a cannabis for PTSD
764
00:41:22.719 --> 00:41:25.920
in three hundred and twenty veterans, and so FDA is
765
00:41:25.960 --> 00:41:28.840
blocking us from doing that study, not permitting us to
766
00:41:28.840 --> 00:41:32.440
study smoked marijuana or vaporized marijuana for reasons that are
767
00:41:32.440 --> 00:41:35.880
not very good. So we've just launched a formal dispute
768
00:41:35.880 --> 00:41:39.639
with lawyer scientists against the FDA two weeks ago trying
769
00:41:39.679 --> 00:41:43.360
to unblock this study with you know, the way people
770
00:41:43.519 --> 00:41:46.679
with PTSD. Veterans with PTSD use cannabis. Some of them
771
00:41:46.679 --> 00:41:49.760
will do it edibles, but most will smoke or vaporize. So,
772
00:41:50.159 --> 00:41:52.800
you know, I find a very amusing in the meeting
773
00:41:52.880 --> 00:41:54.760
we had with the FDA after they blocked it to
774
00:41:54.800 --> 00:41:57.360
try to see if we could come to an agreement
775
00:41:57.400 --> 00:42:00.119
before we do this formal dispute, which will cost three
776
00:42:00.199 --> 00:42:02.480
hundred thousand or son legal fees. We were talking about
777
00:42:02.480 --> 00:42:05.039
this project, and the woman from FDA said, I hate
778
00:42:05.079 --> 00:42:09.559
the word medical marijuana because it's not medical until we
779
00:42:09.719 --> 00:42:12.440
say it. Is said that at a meeting where she's
780
00:42:12.440 --> 00:42:15.960
blocking us from doing research with marijuana. Mind boggling.
781
00:42:16.480 --> 00:42:19.840
So, in terms of your global efforts with MDMA, so
782
00:42:20.320 --> 00:42:23.400
is does Lycos control the patent for MDMA.
783
00:42:24.000 --> 00:42:26.719
No? No, So First off, MDMA was invented by merk
784
00:42:26.800 --> 00:42:29.920
in nineteen twelve, so the molecules in the public domain.
785
00:42:30.480 --> 00:42:33.679
I hired patent attorneys in the late nineteen eighties early
786
00:42:33.800 --> 00:42:36.920
nineteen nineties to help MAPS develop an anti patent for
787
00:42:37.039 --> 00:42:40.360
the uses, which is we publish stories about all different
788
00:42:40.440 --> 00:42:42.440
uses of MDMA, and the website we can say they
789
00:42:42.440 --> 00:42:46.920
invented it. MDMA for postpartum depression, MDMA for fibermyalgia, all
790
00:42:46.920 --> 00:42:49.800
these different things people have said they've received helix. What
791
00:42:49.920 --> 00:42:52.920
Licos is trying to do is to patent the particle
792
00:42:53.039 --> 00:42:58.360
size of the MDMA molecule to optimize it going through
793
00:42:58.679 --> 00:43:03.559
high throughput encapsulation machine. That's the patent that they're going
794
00:43:03.599 --> 00:43:05.559
to try to get. And this is in the public
795
00:43:05.559 --> 00:43:10.280
domain already for them to block generics. Whether they'll get
796
00:43:10.360 --> 00:43:14.079
that or not, I don't know if they do get that,
797
00:43:14.159 --> 00:43:16.719
I think it's easy to not infringe on that patent
798
00:43:16.800 --> 00:43:19.679
and do things in other ways. There's a challenge in
799
00:43:19.719 --> 00:43:22.880
that when you're a pharma company, you can in your
800
00:43:23.199 --> 00:43:25.840
either data exclusivity or one patent is expiring, you've got
801
00:43:25.880 --> 00:43:28.719
another one. You want to delay generics as long as
802
00:43:28.719 --> 00:43:31.320
you can, so you sue them for infringing, and the
803
00:43:31.360 --> 00:43:33.719
FDA is once that those kind of suits happen, the
804
00:43:33.760 --> 00:43:36.000
FDA is automatically blocked for two and a half years
805
00:43:36.440 --> 00:43:39.480
permissioning a license to the generic to give time for
806
00:43:39.519 --> 00:43:42.599
the court lawsuit to work it out. Now, in Australia,
807
00:43:42.679 --> 00:43:45.760
if you are a generic company and your suit for
808
00:43:45.840 --> 00:43:47.599
infringing on the patent and it turns out you don't
809
00:43:47.639 --> 00:43:50.760
infringe on the patent, the company has to pay the
810
00:43:50.800 --> 00:43:53.039
innovator company has to pay your legal fees, but they
811
00:43:53.039 --> 00:43:55.519
have to pay fines because of all the money that
812
00:43:55.559 --> 00:43:58.599
they made when it should have been a generic. There's
813
00:43:58.639 --> 00:44:02.440
no such law like that in the So the other
814
00:44:02.480 --> 00:44:04.960
part of this is that when you are a generic
815
00:44:05.039 --> 00:44:08.599
manufacturer and you have not been sued in forty five days,
816
00:44:09.119 --> 00:44:11.360
you can go to the courts for summary judgment that
817
00:44:11.440 --> 00:44:13.440
you'll never be sued, but the condition is you have
818
00:44:13.519 --> 00:44:16.239
to make your entire package of the FDA available to
819
00:44:16.280 --> 00:44:19.679
the competitor, the innovator company, to look at and see
820
00:44:19.679 --> 00:44:22.719
if there's any evidence of infringement. I said to the
821
00:44:22.760 --> 00:44:25.239
company that when I was still on the lycosport, that
822
00:44:25.320 --> 00:44:27.159
we should make a good faith effort to see if
823
00:44:27.159 --> 00:44:30.360
they infringe before we sue during these forty five days.
824
00:44:30.639 --> 00:44:34.519
That was not well received unfortunately. So I do think
825
00:44:34.559 --> 00:44:39.719
that the effort by Licos to patent particle size is
826
00:44:39.880 --> 00:44:41.360
something that'll probably take a year and a half or
827
00:44:41.400 --> 00:44:44.320
so to figure out if they get it. Now, there's
828
00:44:44.360 --> 00:44:47.360
a company called Tiaran Biosciences. What Licos has done is
829
00:44:47.559 --> 00:44:51.079
MDMA hydrochloride, which is DA with a certain kind of salt.
830
00:44:51.360 --> 00:44:55.159
They're trying to claim that, even though assaults can act differently,
831
00:44:55.760 --> 00:44:59.960
that the patent that they've asked for on particle side,
832
00:45:00.199 --> 00:45:03.960
which they generated from working with MDMA hydrochloride, should apply
833
00:45:04.039 --> 00:45:07.199
to all the different salts that MDMA can be combined
834
00:45:07.239 --> 00:45:10.679
with or manufactured with. So there's another company in Terran
835
00:45:10.719 --> 00:45:14.639
Biosciences that is patent MDMA with a different salt, and
836
00:45:14.679 --> 00:45:18.239
it is claiming that it will not be covered by
837
00:45:18.360 --> 00:45:21.679
the lycos pat and then they want to, you know,
838
00:45:22.079 --> 00:45:25.000
as soon as possible, make MDMA into a generic So
839
00:45:25.440 --> 00:45:26.840
you know, I don't know how that's all going to
840
00:45:26.880 --> 00:45:29.760
play out, but I do think that the problem is
841
00:45:29.800 --> 00:45:32.800
with philanthropal at the part the situation is with philanthropists.
842
00:45:32.800 --> 00:45:36.079
They're not looking to monopoly situations. They're looking to heal
843
00:45:36.159 --> 00:45:39.840
people right doing masters, They're looking not so much to
844
00:45:39.880 --> 00:45:41.719
heal people, but to use healing people as a way
845
00:45:41.719 --> 00:45:46.760
to make money. And so you know, how will patents
846
00:45:46.800 --> 00:45:50.880
be enforced, how will they be applied for? But my
847
00:45:51.440 --> 00:45:54.360
I'm not a patent attorney, but my sense is that
848
00:45:54.480 --> 00:45:58.400
there's a good chance that the salt that Terran Bioscience
849
00:45:58.400 --> 00:46:03.679
has combined with MDMA would not infringe thecos all the
850
00:46:03.719 --> 00:46:05.840
likecos claims that it's worked will apply to all the
851
00:46:05.880 --> 00:46:08.360
different salts to so a lot to see what the
852
00:46:08.440 --> 00:46:09.000
FDA does.
853
00:46:09.199 --> 00:46:12.400
I mean, well, the theologist plays out, and I mean
854
00:46:12.480 --> 00:46:14.960
as fascinating as that is. Systemically, I mean there's so
855
00:46:14.960 --> 00:46:18.559
many there's the economics and a business interests, there's the politics,
856
00:46:18.599 --> 00:46:21.840
there's a cultural forces, and then there's the actual science
857
00:46:21.880 --> 00:46:24.280
and then most importantly, there's the need of people who
858
00:46:24.280 --> 00:46:27.480
are suffering, and that should I think most of we
859
00:46:27.480 --> 00:46:28.440
should predominate.
860
00:46:28.960 --> 00:46:31.320
What I would say is the need is really critical,
861
00:46:31.760 --> 00:46:35.519
but it's the culture that really is where the cultural
862
00:46:35.599 --> 00:46:38.440
change has to take place. That's where I think Lecos
863
00:46:38.440 --> 00:46:41.280
felled down. Is to think it's a rational process. We've
864
00:46:41.320 --> 00:46:43.960
evolved to the point where FDA will just look at
865
00:46:43.960 --> 00:46:47.320
the data. Culture doesn't matter. And that quiet period when
866
00:46:47.320 --> 00:46:50.119
the culture was started to erupt with negativity, and then
867
00:46:50.360 --> 00:46:53.559
the decision was made, oh, let's not apply, not replought,
868
00:46:53.719 --> 00:46:55.760
And that's why I think built and built and built,
869
00:46:55.760 --> 00:46:58.360
and that's what led to the negative outcomes.
870
00:46:58.880 --> 00:47:01.639
Well, speaking of the culture, sure somewhat, I guess parallel
871
00:47:01.880 --> 00:47:04.960
trajectories and forces and trends. On the one hand, the
872
00:47:05.679 --> 00:47:09.960
efforts to reschedule schedule one psychic medicines for therapeutic use
873
00:47:10.119 --> 00:47:13.559
and the medicalization of those to create distribution systems and
874
00:47:13.639 --> 00:47:16.320
third party payment with insurers.
875
00:47:15.800 --> 00:47:18.599
In that whole world, and then.
876
00:47:18.480 --> 00:47:23.760
This psychaic renaissance that's going on, and the widespread semi
877
00:47:23.800 --> 00:47:27.559
above ground, semi blow ground use by people for personal growth.
878
00:47:27.679 --> 00:47:30.079
I mean some recreational obviously, and some of it may
879
00:47:30.079 --> 00:47:33.079
not be but a lot of people really looking spiritual growth,
880
00:47:33.079 --> 00:47:35.719
personal growth and going all around the world to do
881
00:47:35.760 --> 00:47:38.000
it as well. And then here in the US, some
882
00:47:38.639 --> 00:47:44.119
as you mentioned in Oakland, California and Colorado, possibly in Massachusetts,
883
00:47:44.400 --> 00:47:47.559
in Oregon, there's there's these efforts of decriminalization and some
884
00:47:47.599 --> 00:47:51.400
active decriminalization and policy making happening. And so I wonder
885
00:47:52.039 --> 00:47:55.920
how you see these two parallel worlds operating. Is there
886
00:47:56.000 --> 00:47:58.719
can there be a mutual benefit that will move things
887
00:47:58.760 --> 00:48:02.159
down the field, or they cross purposes sometimes or.
888
00:48:02.559 --> 00:48:05.239
Well I think that Lycos feels that they're at cross purposes,
889
00:48:05.280 --> 00:48:08.599
but I think they're mutually supportive. So, as I said,
890
00:48:08.639 --> 00:48:11.320
it's really about the culture. I mean, psychedelic research was
891
00:48:11.360 --> 00:48:15.159
blocked for more than two decades. That's not because of
892
00:48:15.199 --> 00:48:18.480
the science from the nineteen seventy controls obs SEC That's
893
00:48:18.480 --> 00:48:21.920
because of politics. That's because of culture. That's because of
894
00:48:21.960 --> 00:48:25.519
the fear engendered in people about psychedelics. So I think
895
00:48:25.519 --> 00:48:29.920
that the culture is the critical factor, and that that's
896
00:48:29.960 --> 00:48:33.679
something that we constantly be needing to be educating people
897
00:48:33.760 --> 00:48:37.639
about things like that, and that this idea of how
898
00:48:37.679 --> 00:48:39.880
do we do this public education? The most important thing
899
00:48:39.920 --> 00:48:43.480
is people telling their stories about having their own healing experiences.
900
00:48:43.480 --> 00:48:45.599
So what we really need is sort of a psychedelic
901
00:48:45.639 --> 00:48:48.079
coming out of all sorts of people that have benefited
902
00:48:48.119 --> 00:48:51.719
from psychedelics, you know, speaking in public about it, so
903
00:48:51.840 --> 00:48:55.639
to help people understand more from people that they trust
904
00:48:55.679 --> 00:49:00.360
about benefits, to balance off all the negativity so much
905
00:49:00.599 --> 00:49:04.559
hopeful over time, what will happen is more and more
906
00:49:04.599 --> 00:49:07.719
research will come out, more and more positive research will
907
00:49:07.719 --> 00:49:11.079
come out, and they'll be this sort of return to
908
00:49:11.320 --> 00:49:14.320
hope over fear in the public. And that's what we
909
00:49:14.400 --> 00:49:15.360
really need to be counting on.
910
00:49:16.400 --> 00:49:19.679
I'm curious you mentioned education, So it seemed to me that,
911
00:49:19.920 --> 00:49:22.920
you know, if we're going to get this positive cultural
912
00:49:22.960 --> 00:49:28.400
shift and attitudes or psychedelic medicines and eventually decriminalization or
913
00:49:28.440 --> 00:49:32.440
even legalization in certain areas and more availabily not only
914
00:49:32.920 --> 00:49:36.480
medically prescribed therapy, but for people to explore on their own.
915
00:49:36.679 --> 00:49:38.599
And you know, there's a feeling among many people that
916
00:49:38.800 --> 00:49:42.719
natural plants, anybody should have access to those that along
917
00:49:42.760 --> 00:49:45.199
with ours. All the reasons why we maybe think that's
918
00:49:45.199 --> 00:49:47.559
the way it should be, if we want it that way,
919
00:49:47.599 --> 00:49:51.079
it seems like it's incumbent upon the movement to really
920
00:49:51.119 --> 00:49:52.920
do a lot of education so that we have a
921
00:49:53.000 --> 00:49:57.000
very well educated public. Because these medicines can be powerful,
922
00:49:57.199 --> 00:50:00.920
they can be destabilizing some cases. Overall, compared to a
923
00:50:01.000 --> 00:50:04.079
lot of things, they're pretty benevolent, even compared with alcohol
924
00:50:04.079 --> 00:50:06.800
in many cases. But is still there the idea of
925
00:50:06.840 --> 00:50:10.400
creating an educated consumer, so you avoid a lot, you know,
926
00:50:10.480 --> 00:50:12.920
so you really focused on harm reduction through education. I
927
00:50:12.960 --> 00:50:14.960
guess maybe the point I'm making here.
928
00:50:15.320 --> 00:50:18.280
Yeah, So normally the way that this sort of public
929
00:50:18.400 --> 00:50:22.039
education gets done is with advertising dollars. You know, there's
930
00:50:22.079 --> 00:50:24.679
no product, so that doesn't happen. The way that we've
931
00:50:24.719 --> 00:50:27.119
done it in the past is through doing science because
932
00:50:27.159 --> 00:50:31.599
in our culture, science gets widely reported and that's earned
933
00:50:31.719 --> 00:50:34.800
media that you don't have to pay for. So concentrating
934
00:50:34.840 --> 00:50:37.440
resources on doing the science and then getting the media
935
00:50:37.519 --> 00:50:40.639
to report about it is what's been essential. But there
936
00:50:40.679 --> 00:50:43.880
are still so many people that have not heard these stories,
937
00:50:43.880 --> 00:50:47.239
that don't This is just another This is a while ago,
938
00:50:47.280 --> 00:50:49.239
but the very first date I ever had it with
939
00:50:49.280 --> 00:50:52.119
my wife. Now we've been married thirty one years, but
940
00:50:52.440 --> 00:50:55.480
this was now in nineteen eighty nine. She was a
941
00:50:55.519 --> 00:50:58.239
student at Harvard's Kennedy School Government and we have this
942
00:50:58.360 --> 00:51:00.639
lunch together and at the end, she said, you know,
943
00:51:00.679 --> 00:51:02.079
I just want to tell you I'd never want to
944
00:51:02.079 --> 00:51:04.800
have a relationship, for real relationship with anybody like you.
945
00:51:05.280 --> 00:51:08.000
And I'm like, why is that, you know? And she said, well,
946
00:51:08.000 --> 00:51:10.880
you've done so much LSD your chromosomes are all screwed up.
947
00:51:11.360 --> 00:51:13.639
I'm like, it was kind of funny. I said, it
948
00:51:13.639 --> 00:51:16.159
may be premature, but let me defend my spurn here.
949
00:51:16.360 --> 00:51:18.519
The point I'm trying to make is that she, an
950
00:51:18.559 --> 00:51:24.199
intelligent woman, believed the propaganda right about LSD causing chromosome damage,
951
00:51:24.199 --> 00:51:26.760
which it does not do in any way that affects
952
00:51:26.800 --> 00:51:30.840
a childbirth. So how do we really do this public education?
953
00:51:30.920 --> 00:51:33.000
That's a big part of the Psychedelic Science twenty twenty
954
00:51:33.000 --> 00:51:35.920
five conference we're going to have in June. But well,
955
00:51:36.079 --> 00:51:38.039
and that's why I'm talking to you. I think podcasts
956
00:51:38.039 --> 00:51:41.000
are really helpful, but we need the documentaries on therapists.
957
00:51:41.000 --> 00:51:43.840
There's multiple documentaries that we're trying to help. There's a
958
00:51:44.000 --> 00:51:46.559
feature film that's being made about the book Acid Test
959
00:51:46.719 --> 00:51:49.920
LSD Ecstasy in the Party Heal about our movie that
960
00:51:50.000 --> 00:51:52.320
was going to be with participant media. But then participant
961
00:51:52.360 --> 00:51:53.960
media shut down. So I don't know if they're going
962
00:51:54.000 --> 00:51:57.199
to find the funding or not. But I think I
963
00:51:57.239 --> 00:51:59.599
took a class at hard School of Public Health by
964
00:51:59.599 --> 00:52:03.880
the guy that it introduced helped introduce designated drivers into
965
00:52:03.920 --> 00:52:07.840
the American culture, and he did that through TV shows
966
00:52:07.880 --> 00:52:12.599
and movies having somebody be the designated driver. So that's
967
00:52:12.599 --> 00:52:14.440
what we're trying to do. In terms of your public
968
00:52:14.559 --> 00:52:18.280
education question. The more we can get stories in media,
969
00:52:18.719 --> 00:52:22.960
even fictional stories, the more people will be educated. I mean,
970
00:52:23.480 --> 00:52:26.039
you know, there's just such an enormous reservoir of fear
971
00:52:26.039 --> 00:52:28.480
and misinformation that people have, So we have to do
972
00:52:28.559 --> 00:52:31.320
whatever we can for public education. And I think it's
973
00:52:31.360 --> 00:52:33.920
really important that you're putting your finger at that, and
974
00:52:33.960 --> 00:52:36.119
that is something that we really need to figure out
975
00:52:36.159 --> 00:52:39.800
how to do. But without you know, now, you know,
976
00:52:40.039 --> 00:52:42.960
chos will do some science, but they're going to shy
977
00:52:42.960 --> 00:52:45.920
away I think from public education. I think it's really
978
00:52:45.960 --> 00:52:47.800
through the science that we've been able to make the
979
00:52:47.840 --> 00:52:50.960
progress that we have. And now I think some documentaries
980
00:52:50.960 --> 00:52:54.760
of patients telling their stories will be really effective. Well, yeah,
981
00:52:54.960 --> 00:52:58.119
that's the key. We've got a population that well, you
982
00:52:58.199 --> 00:53:01.679
hear one story of one boundary violation by a therapist
983
00:53:02.360 --> 00:53:05.760
and that becomes the dominant story.
984
00:53:05.880 --> 00:53:09.079
I've been above in criminal justice reform in prison work
985
00:53:09.159 --> 00:53:12.519
for a long time, and they talk about incident driven politics.
986
00:53:13.239 --> 00:53:15.880
You know, you have, for example, community corrections, which has
987
00:53:15.920 --> 00:53:19.920
proven to work. It's vastly inexpensive compared to incarcerating people.
988
00:53:20.320 --> 00:53:23.039
But you have one person on proll that messes up,
989
00:53:23.079 --> 00:53:25.360
and suddenly you're going to change the whole policy and
990
00:53:25.400 --> 00:53:28.400
spend a gazillion dollars locking everybody up when actually has
991
00:53:28.440 --> 00:53:31.159
been proven the statistically, it makes total sense to keep
992
00:53:31.159 --> 00:53:33.360
a lot of people in the community. So that incident
993
00:53:33.480 --> 00:53:36.280
driven politics kind of affect a lot of things. I'm
994
00:53:36.320 --> 00:53:37.760
curious about this idea.
995
00:53:37.800 --> 00:53:38.039
You know.
996
00:53:38.239 --> 00:53:41.159
So we're training therapists, and I think a really important
997
00:53:41.239 --> 00:53:43.760
terms of the therapeutic use of psychotic medicines that the
998
00:53:43.840 --> 00:53:46.440
training be really good, the standards be really good. I
999
00:53:46.480 --> 00:53:49.320
know MAPS had a training program for the therapists involved
1000
00:53:49.320 --> 00:53:53.159
in your clinical TRIALCYIS and Europa both have master's level
1001
00:53:53.480 --> 00:53:57.239
professional programs. I think I entered while at Unie Arizona's
1002
00:53:57.239 --> 00:53:59.800
developing one for positions and so forth, So you know,
1003
00:54:00.000 --> 00:54:02.960
developing excellent training, and there's probably some training being developed
1004
00:54:02.960 --> 00:54:06.679
for non clinical guides as well. I'm curious about in
1005
00:54:06.760 --> 00:54:09.679
states where there's an effort at decriminalization even around the
1006
00:54:09.679 --> 00:54:13.880
planet medicines, the idea of almost you know, requiring US
1007
00:54:13.920 --> 00:54:18.159
citizens license of sort, citizens use license. I mean, even
1008
00:54:18.199 --> 00:54:20.440
with the you know, the way marijuana has been, you know,
1009
00:54:20.519 --> 00:54:23.920
legalized recreationally, that someone be required to go through some
1010
00:54:24.000 --> 00:54:26.519
kind of just like to get a driver's license, go
1011
00:54:26.599 --> 00:54:28.960
to some kind of training and take a test, at
1012
00:54:29.039 --> 00:54:30.840
least pass the test, and of course people could gain
1013
00:54:30.880 --> 00:54:32.679
it in this and that, but still on the whole,
1014
00:54:33.039 --> 00:54:36.880
people would get some basic education, harm reduction education. So
1015
00:54:37.280 --> 00:54:40.880
if they're going to use psychaltics for personal exploration growth,
1016
00:54:40.920 --> 00:54:43.119
they would at least be more well informed if there
1017
00:54:43.199 --> 00:54:44.079
wasn't something like this.
1018
00:54:44.639 --> 00:54:48.599
I think that's a phenomenal idea. Yeah, we definitely so
1019
00:54:49.320 --> 00:54:52.840
in the training of therapists, you know, one of the
1020
00:54:52.960 --> 00:54:58.719
key controversial aspects of it is therapist self experience a
1021
00:54:58.840 --> 00:55:01.239
drug that they're going to give to the patients. Now,
1022
00:55:01.760 --> 00:55:04.360
for example, you would probably never take ice skating lessons
1023
00:55:04.360 --> 00:55:06.679
from somebody that never ice skated. You would never go
1024
00:55:06.719 --> 00:55:09.760
to an ayahuasca shaman that had never done ayahuasca. You
1025
00:55:09.800 --> 00:55:13.079
wouldn't go take flying lessons from somebody that never flew
1026
00:55:13.119 --> 00:55:16.440
a plane. Now psychiatrists will say, oh, I give ECT
1027
00:55:16.559 --> 00:55:20.039
electric convulsive therapy, and I give antipsychotics to my patients,
1028
00:55:20.039 --> 00:55:22.400
and I don't need to take them myself, And in
1029
00:55:22.440 --> 00:55:25.000
that case they're right, they don't, because what they're talking
1030
00:55:25.039 --> 00:55:28.679
about is that the ECT is the therapy. The antipsychotics
1031
00:55:28.719 --> 00:55:31.920
are the medicine. They're the therapy. But in psychedelica syst
1032
00:55:31.920 --> 00:55:34.840
the therapy the therapist is part of the treatment. They're
1033
00:55:34.880 --> 00:55:37.559
part of the medicine, They're part of what's helping people
1034
00:55:37.559 --> 00:55:39.920
get better. I think they're more important than the MDMA.
1035
00:55:40.519 --> 00:55:42.400
That's what we said that forty percent of people in
1036
00:55:42.400 --> 00:55:44.599
our study had done MDMA, but they still had PTSD.
1037
00:55:45.320 --> 00:55:49.000
So I think this idea of how do we train therapists,
1038
00:55:49.039 --> 00:55:51.440
and this idea of having them have their own self
1039
00:55:51.480 --> 00:55:55.480
experience is really important. I think the harm reduction what
1040
00:55:55.519 --> 00:55:57.719
we want to do is sort of expand the culture.
1041
00:55:57.800 --> 00:56:00.880
So how do we move to a post probish world?
1042
00:56:01.000 --> 00:56:04.559
And also how do I sort of balance two different things.
1043
00:56:04.559 --> 00:56:08.800
One is MDMA should become a medicine. Administered only under
1044
00:56:08.840 --> 00:56:12.800
direct supervision of therapists who were specially trained, with all
1045
00:56:12.840 --> 00:56:15.639
of that covered by insurance. On the one hand, and
1046
00:56:15.719 --> 00:56:17.159
on the other hand, I'm saying, hey, it should be
1047
00:56:17.199 --> 00:56:18.880
legal for people to just be able to get on
1048
00:56:18.880 --> 00:56:22.079
their own as a fundamental human right to explore their consciousness.
1049
00:56:22.159 --> 00:56:24.159
That will be a lot less risky, I mean a
1050
00:56:24.199 --> 00:56:26.920
lot riskier to just have people. But I think that
1051
00:56:27.360 --> 00:56:30.239
the drug war is worse. But what I really liked
1052
00:56:30.440 --> 00:56:33.159
was your focus on a license. And I think that
1053
00:56:33.320 --> 00:56:35.519
is the key, and we don't hear about it enough,
1054
00:56:35.920 --> 00:56:39.719
but I've talked about licensed legalization, and the idea here
1055
00:56:39.800 --> 00:56:42.079
is that let's say you're a drunk driver and you
1056
00:56:42.119 --> 00:56:46.119
get pulled over for DUI and you lose your driver's license. Well,
1057
00:56:46.639 --> 00:56:48.199
you can go to a liquor store, you can go
1058
00:56:48.280 --> 00:56:50.199
to a bar, and you can still get alcohol. You
1059
00:56:50.199 --> 00:56:52.559
can still get into your car, drive drunk and kill people.
1060
00:56:53.000 --> 00:56:56.199
But if you had a license to buy alcohol, and
1061
00:56:56.239 --> 00:56:59.960
this license was basically simple to get, the main point
1062
00:57:00.159 --> 00:57:02.679
is that you could lose it if you misbehave. And
1063
00:57:02.719 --> 00:57:05.519
we all know how quickly people can check our credit
1064
00:57:05.519 --> 00:57:07.840
cards for us to pay for stuff. It takes seconds
1065
00:57:08.320 --> 00:57:11.239
you know, it's extremely fast. So I like the idea
1066
00:57:11.519 --> 00:57:13.960
very much, but there's very few people talking about a
1067
00:57:14.039 --> 00:57:17.719
license to do cannabis, a license to do alcohol, and
1068
00:57:17.760 --> 00:57:20.800
then you would have different licenses to do psychedelics and
1069
00:57:20.880 --> 00:57:23.320
all these drugs, and I think furthermore, heroin, cocaine, all
1070
00:57:23.320 --> 00:57:26.119
these drugs should be made legal with licenses and with
1071
00:57:26.559 --> 00:57:31.519
proper support, and with harm reduction and opportunities for treatment
1072
00:57:31.559 --> 00:57:33.639
on demand. When you treat people as humans, a lot
1073
00:57:33.679 --> 00:57:36.480
of these people will want treatment. They don't necessarily want
1074
00:57:36.480 --> 00:57:39.280
to stay addicted to drugs. But when you push them underground,
1075
00:57:39.400 --> 00:57:41.920
you push them awave from help. That's not the way
1076
00:57:41.920 --> 00:57:43.840
to get the best results, and then you fuel this
1077
00:57:44.039 --> 00:57:48.199
vast criminal underground. And so I think licensed legalization is
1078
00:57:48.280 --> 00:57:51.840
kind of this midway between Oh, people think, oh, everybody
1079
00:57:51.840 --> 00:57:54.039
can get it for any reason, and that's too dangerous.
1080
00:57:54.440 --> 00:57:57.239
But the license makes it so that if people misbehave
1081
00:57:57.360 --> 00:57:59.800
under the influence of the drug, you've now made it
1082
00:57:59.840 --> 00:58:02.159
hard for them to get that drug, And that just
1083
00:58:02.199 --> 00:58:05.239
makes logical sense. The one main argument I've heard against
1084
00:58:05.239 --> 00:58:08.920
this idea is that then we know how governments switch
1085
00:58:08.960 --> 00:58:12.199
all the time and policies switch, So if you have
1086
00:58:12.280 --> 00:58:13.880
a license, then you've got a list of all the
1087
00:58:13.880 --> 00:58:16.639
people that are using this drug, say it's marijuana or MPTMA.
1088
00:58:16.679 --> 00:58:19.079
And then government shifts and now all of a sudden,
1089
00:58:19.159 --> 00:58:22.519
the new government, which as marijuana, is a list of
1090
00:58:22.559 --> 00:58:24.679
all the people that used it in the past. Now
1091
00:58:25.119 --> 00:58:28.519
they still can go after credit card records to see
1092
00:58:28.559 --> 00:58:30.920
where people have shopped. You know, there's still a lot
1093
00:58:30.920 --> 00:58:33.719
of information for them to tell who's who. But that's
1094
00:58:33.760 --> 00:58:37.320
the main reasons I think I've heard against licensed legalization.
1095
00:58:37.440 --> 00:58:41.039
But I'm curious where you started thinking about that, because
1096
00:58:41.079 --> 00:58:42.800
there's not that many people that think about that.
1097
00:58:43.400 --> 00:58:46.239
Yeah, it just occurred to me, and it's come up
1098
00:58:46.280 --> 00:58:49.199
around other things. There are many things that we do
1099
00:58:49.280 --> 00:58:52.519
in society that we don't need training for, have a
1100
00:58:52.599 --> 00:58:55.719
license for, and maybe they're just considered natural human right.
1101
00:58:55.800 --> 00:58:57.800
But the weather. There's a lot of issues. I mean,
1102
00:58:57.840 --> 00:58:59.760
one that has come out probably get in trouble saying this,
1103
00:58:59.800 --> 00:59:01.719
but one that's come up for me is is the
1104
00:59:01.760 --> 00:59:05.039
whole world of recreational bicycling. You know, and I've been
1105
00:59:05.079 --> 00:59:08.519
a recreational bicyclist, not avid, but have been. But you know,
1106
00:59:08.559 --> 00:59:12.360
we're asked to share the roads and if thrivers misbehave
1107
00:59:12.599 --> 00:59:15.119
somebody can get their license number and they will quickly
1108
00:59:15.159 --> 00:59:16.920
be in trouble and report it and be in trouble.
1109
00:59:17.159 --> 00:59:20.880
A bicyclist completely, you know, off the grid. There's no
1110
00:59:21.000 --> 00:59:23.880
way to track nothing, right, And so you know, if
1111
00:59:23.960 --> 00:59:26.880
people had to get a license to some education around
1112
00:59:26.960 --> 00:59:29.320
riding a bicycle on the roads, had to have a
1113
00:59:29.320 --> 00:59:31.880
little license plate, that would help pay for the you
1114
00:59:31.920 --> 00:59:34.119
know the thing. But you know, I mean even today
1115
00:59:34.159 --> 00:59:37.039
now we get kids out on the streets with electric scooters,
1116
00:59:37.480 --> 00:59:41.719
no license required. You know, I see families a bicycle
1117
00:59:41.800 --> 00:59:44.320
going down the street pulling a little trailer behind it
1118
00:59:44.360 --> 00:59:46.400
with an infinet it out on the street mixed with
1119
00:59:46.480 --> 00:59:49.000
cars and it's legal. You know. So there's a lot
1120
00:59:49.000 --> 00:59:51.320
of these things that are kind of nonsensical, and you know,
1121
00:59:51.360 --> 00:59:53.880
and it's again, you know, I'm not you know, I
1122
00:59:53.920 --> 00:59:55.440
have a part of my brain is a bit of
1123
00:59:55.440 --> 00:59:58.119
a you know, not an anarchist, but so a little
1124
00:59:58.119 --> 00:59:59.840
bit of a living and so the idea of over
1125
01:00:00.000 --> 01:00:02.360
regulating society and having to have permits to do everything
1126
01:00:02.440 --> 01:00:04.440
is not that attractive either. But with some of these
1127
01:00:04.440 --> 01:00:07.079
things that you know, whether there are risks involved, how
1128
01:00:07.119 --> 01:00:09.440
do we try to reduce harm and assure that the
1129
01:00:09.519 --> 01:00:11.440
consumer is well educated.
1130
01:00:11.079 --> 01:00:11.960
I think is the point.
1131
01:00:12.159 --> 01:00:14.480
And also I think you framed it quite beautifully. How
1132
01:00:14.519 --> 01:00:18.679
do we envision a post prohibition world and what does
1133
01:00:18.719 --> 01:00:20.519
that look like? And how do we do that safely
1134
01:00:20.559 --> 01:00:23.239
so that we're not continuing these cycles of backlash and
1135
01:00:23.239 --> 01:00:25.719
them problems and so forth. And it'll never be able
1136
01:00:25.760 --> 01:00:27.599
to be perfect, but everything we can do to make
1137
01:00:27.639 --> 01:00:29.920
it as good and as risky as possible.
1138
01:00:30.440 --> 01:00:32.239
Yeah, I think what we need is pure drug Well,
1139
01:00:32.280 --> 01:00:35.599
first off, we need honest drug education at schools we
1140
01:00:35.639 --> 01:00:39.119
should not have. Then we need pure drugs so that
1141
01:00:39.119 --> 01:00:41.639
people are not dying from contaminated drugs or they know
1142
01:00:41.719 --> 01:00:44.159
the doses, they're not taking drug that all of a sudden,
1143
01:00:44.199 --> 01:00:46.159
is twice as strong as they thought it was. Then
1144
01:00:46.239 --> 01:00:49.880
we need harm reduction trainings for people to provide peer
1145
01:00:49.920 --> 01:00:53.840
support for each other when sechno experiences often can get difficult,
1146
01:00:54.039 --> 01:00:55.960
but it's not a sign that it's a bad trip.
1147
01:00:56.320 --> 01:00:59.079
You need to work on what's difficult. And then also
1148
01:00:59.679 --> 01:01:02.400
so we do the Zendo Project at berning Man. We
1149
01:01:02.440 --> 01:01:05.960
have hundreds of volunteers to provide peer support to people
1150
01:01:06.039 --> 01:01:08.159
that have difficult trips. This year, we had over four
1151
01:01:08.239 --> 01:01:11.360
hundred people come for help. Even in the sort of
1152
01:01:11.400 --> 01:01:14.480
sophisticated environment of Burning Man, where people you presume are
1153
01:01:14.519 --> 01:01:17.719
comfortable with psychedelics, four hundred people said that they had
1154
01:01:17.800 --> 01:01:20.679
experiences that were deeper and more profound or more troublesome
1155
01:01:20.719 --> 01:01:23.760
than they thought, and they came for assistance with this
1156
01:01:23.800 --> 01:01:26.159
group of peer support. And then we need treatment on
1157
01:01:26.199 --> 01:01:28.639
demand for those people that do get addicted to something,
1158
01:01:29.000 --> 01:01:31.719
whatever it happens to be, and they can get treatment
1159
01:01:31.880 --> 01:01:33.599
if they want it, and those I think will make
1160
01:01:33.679 --> 01:01:37.119
post prohibition world work. But the drug war is so
1161
01:01:37.280 --> 01:01:40.400
counterproductive and so negative that we can switch right away.
1162
01:01:40.519 --> 01:01:43.199
If we could, even without all these policies in place,
1163
01:01:43.199 --> 01:01:46.320
they would still be a benefit to society. But I
1164
01:01:46.360 --> 01:01:48.639
do encourage you to sort of keep talking about the
1165
01:01:48.800 --> 01:01:51.119
license idea because it's a really good one.
1166
01:01:51.440 --> 01:01:53.280
Well, I'll be there in Denver in June, so I'll
1167
01:01:53.280 --> 01:01:56.280
see if I can get anybody interested there. I was
1168
01:01:56.280 --> 01:01:58.360
there last year and it was quite an amazing event.
1169
01:01:59.000 --> 01:02:01.320
So I wonder about well, you know, we're talking about
1170
01:02:01.320 --> 01:02:05.679
cultural change, and even in political change and mindset change,
1171
01:02:05.719 --> 01:02:09.679
heartset change, and so a lot of the psychedelic medicines
1172
01:02:09.960 --> 01:02:15.079
can produce trans personal experiences that have in many cases
1173
01:02:15.199 --> 01:02:19.800
changed someone's mindset, heartset, world view. And so I'm wondering
1174
01:02:19.840 --> 01:02:23.119
about the role of that if there's some you know,
1175
01:02:23.159 --> 01:02:24.920
I mean, back in the sixties, many of us had
1176
01:02:24.920 --> 01:02:26.800
the idea, if we could just give all the influential
1177
01:02:26.840 --> 01:02:29.119
people and leaders in the worldality.
1178
01:02:28.599 --> 01:02:30.000
The whole world, change it all be beautiful.
1179
01:02:30.000 --> 01:02:32.519
It didn't quite work out that way, but still I
1180
01:02:32.559 --> 01:02:35.280
think there is the idea that there's something in the
1181
01:02:35.320 --> 01:02:39.920
world of psychedelics that is related to changes in consciousness
1182
01:02:40.000 --> 01:02:42.880
that could be positive for the world. Care about the environment,
1183
01:02:42.960 --> 01:02:46.480
care about others, profound it or connectedness, you know, all
1184
01:02:46.559 --> 01:02:48.719
kinds of things. And so I'm curious about your thoughts
1185
01:02:48.719 --> 01:02:51.920
about that long range or even in the short term.
1186
01:02:52.159 --> 01:02:54.920
Well, that's what really motivated me at eighteen in nineteen
1187
01:02:54.960 --> 01:02:57.800
seventy two, is to devote my life to psychedelics. Now,
1188
01:02:57.880 --> 01:03:00.920
that was to help normalize that. I want to talk
1189
01:03:00.960 --> 01:03:03.519
about the astronauts going to the moon. And we just
1190
01:03:03.559 --> 01:03:06.119
got a quote I just read earlier today about one
1191
01:03:06.119 --> 01:03:10.519
of the first private funded spacewalk in history, a billionaire guy,
1192
01:03:10.519 --> 01:03:12.480
and he said, oh, you know, from up here, the
1193
01:03:12.559 --> 01:03:15.039
Earth looks like this incredibly beautiful thing. We have got
1194
01:03:15.039 --> 01:03:16.639
a lot of problems on Earth, but from up here,
1195
01:03:16.679 --> 01:03:20.719
it just looks like this super rare, beautiful thing. The astronauts,
1196
01:03:20.760 --> 01:03:23.239
some of them Edgar Mitchell in particular, talked about seeing
1197
01:03:23.280 --> 01:03:27.320
the Earth from space and how that changed his mindset.
1198
01:03:27.599 --> 01:03:30.280
So I think this idea that you see the Earth
1199
01:03:30.320 --> 01:03:32.519
as one thing. You don't see the religions, you don't
1200
01:03:32.559 --> 01:03:34.559
see the borders, you don't see the races, you don't
1201
01:03:34.599 --> 01:03:37.480
see the genders. You just see that we're all living
1202
01:03:37.559 --> 01:03:42.159
on this one little, miraculous little planet that somehow has
1203
01:03:42.239 --> 01:03:44.679
life on it, and we're not aware of life anywhere else,
1204
01:03:45.159 --> 01:03:47.480
but we're all part of the same thing. And if
1205
01:03:47.480 --> 01:03:50.519
you can see it that way, the astronauts have said
1206
01:03:50.519 --> 01:03:54.719
that's changed their opinion. So this psychedelic, mystical experience, feeling
1207
01:03:54.719 --> 01:03:58.079
that your unity, you're part of everything, going beyond your
1208
01:03:58.119 --> 01:04:01.159
ego sense, which is there to protect this body, but
1209
01:04:01.480 --> 01:04:03.519
going beyond that, you see this body as part of
1210
01:04:03.559 --> 01:04:06.400
billions of years of history, and you know that there
1211
01:04:06.400 --> 01:04:09.480
were more like ants in an anhill than you know,
1212
01:04:09.639 --> 01:04:14.079
unique individuals. That there's this sentence that if we're all
1213
01:04:14.079 --> 01:04:17.039
in it together. How do you dehumanize other people because
1214
01:04:17.039 --> 01:04:18.960
we're all the same. How do you say, oh, nature,
1215
01:04:19.039 --> 01:04:21.920
let's just throw trash out because it's out. Well, there's
1216
01:04:21.920 --> 01:04:24.360
no out in nature, you know, and we're all responsible
1217
01:04:24.440 --> 01:04:26.599
for global warming, and how do we deal with it?
1218
01:04:26.679 --> 01:04:28.920
So I do think that there's been a couple of
1219
01:04:28.920 --> 01:04:31.960
studies have shown that psilocybin mystical experiences lead to a
1220
01:04:32.079 --> 01:04:37.000
nature relatedness, increased nature relatedness, and there's some other studies
1221
01:04:37.079 --> 01:04:40.400
that talk about, you know, this relationship between the mystical
1222
01:04:40.440 --> 01:04:44.599
experience and therapeutic outcomes. The more you feel connected in
1223
01:04:44.639 --> 01:04:47.320
this way to everything, the more people are able to
1224
01:04:47.320 --> 01:04:51.440
get over depression and anxiety OCD addiction. So I think
1225
01:04:51.480 --> 01:04:56.320
that this kind of cultural change consciousness shift. Clearly we're
1226
01:04:56.320 --> 01:04:59.079
in danger as a species. You know, the amount of
1227
01:04:59.119 --> 01:05:04.199
extinctions that are going on now is unprecedented, and the
1228
01:05:04.239 --> 01:05:07.039
what we're doing to the environment and the rapid change
1229
01:05:07.119 --> 01:05:12.159
that is happening now is also unprecedented. And the way
1230
01:05:12.199 --> 01:05:14.119
I would look at it is, let's just talk about
1231
01:05:14.119 --> 01:05:16.840
Galileo and Copernicus. You know, So there was the thing
1232
01:05:16.920 --> 01:05:19.199
that the Earth was the center of the universe, right
1233
01:05:19.280 --> 01:05:22.079
and then Galileo and Copernicus were like, no, that's not
1234
01:05:22.119 --> 01:05:26.039
the case. Galileo was arrested, was under house arrest by
1235
01:05:26.079 --> 01:05:29.639
the Church because they didn't like this idea that the
1236
01:05:29.679 --> 01:05:33.079
Earth was not the center of the universe. Father Bruno,
1237
01:05:33.239 --> 01:05:36.920
who was both into the plant medicines and into studies
1238
01:05:36.960 --> 01:05:39.760
of Copernicus, was burned at the stake by the Church,
1239
01:05:40.440 --> 01:05:43.400
and at the time that the Inquisition sentenced him, he said,
1240
01:05:43.519 --> 01:05:47.719
your fear in sentencing me is greater than my fear
1241
01:05:47.840 --> 01:05:52.400
in being sentenced. The people's worldview was so integral to
1242
01:05:52.440 --> 01:05:54.760
who they were, and it was so shattering that, oh,
1243
01:05:54.880 --> 01:05:56.800
you know, we're not the center of the universe. So
1244
01:05:56.960 --> 01:06:01.079
I think what we have now is this crisis. EO.
1245
01:06:01.159 --> 01:06:03.679
Wilson said it really well. He said that real problem
1246
01:06:03.719 --> 01:06:10.119
with humanity is that we have paleolithic emotions with medieval institutions,
1247
01:06:10.159 --> 01:06:15.119
with godlike technologies. God have the emotions and spiritual capacity
1248
01:06:15.159 --> 01:06:17.840
to deal with the world that we've created through our minds,
1249
01:06:17.880 --> 01:06:22.119
through our science, and so we need this evolution of consciousness.
1250
01:06:22.519 --> 01:06:25.400
And I think that we're at a stage in humanity where,
1251
01:06:25.440 --> 01:06:29.000
through the Internet and through satellites and through where everybody
1252
01:06:29.039 --> 01:06:33.039
is and through global warming, people are thinking more globally.
1253
01:06:33.079 --> 01:06:35.639
And then I want to talk about humanistic psychology and
1254
01:06:35.639 --> 01:06:39.400
Abraham Manislow. So most people are taught in school about
1255
01:06:39.400 --> 01:06:42.360
the hierarchy of needs, this triangle, this hierarchy of needs.
1256
01:06:42.760 --> 01:06:45.719
It starts with your survival needs and your belonging needs,
1257
01:06:45.719 --> 01:06:47.559
and then your self esteem, and it goes on and on.
1258
01:06:48.000 --> 01:06:51.599
And the highest point that people are taught is self actualization.
1259
01:06:52.159 --> 01:06:55.119
That this is almost like the libertarian dream that you know,
1260
01:06:55.239 --> 01:06:58.519
you become your full self. That's this hierarchy of needs.
1261
01:06:59.079 --> 01:07:01.880
And this this was in the sixties, the mid sixties
1262
01:07:01.880 --> 01:07:05.400
that Abraham Maslow developed this. However, in the end of
1263
01:07:05.440 --> 01:07:09.199
the sixties he changed it, and people are not taught
1264
01:07:09.440 --> 01:07:13.360
what he changed. But what he changed is above self
1265
01:07:13.400 --> 01:07:18.079
actualization is something new, and he called it self transcendence.
1266
01:07:18.760 --> 01:07:21.599
It is this exact thing you're talking about, this mysticalhostre,
1267
01:07:21.679 --> 01:07:24.239
the sense we're big connected to something bigger than ourselves.
1268
01:07:24.760 --> 01:07:28.519
That's I think the consciousness shift that humanity needs to make.
1269
01:07:29.000 --> 01:07:31.800
You know, many people humanity are down at this lower
1270
01:07:31.920 --> 01:07:35.800
level of survival because we have inequitable access to resources,
1271
01:07:35.840 --> 01:07:38.960
we have exploitation, and we have greed many, many people
1272
01:07:39.000 --> 01:07:43.000
are barely surviving in poverty. So it's hard to think
1273
01:07:43.039 --> 01:07:45.840
about self transcendence when you're starving to death or you know,
1274
01:07:45.880 --> 01:07:48.280
so you have to satisfy these needs. But if we
1275
01:07:48.280 --> 01:07:50.360
are to get to more and more people that believed
1276
01:07:50.360 --> 01:07:55.039
in self transcendence, there are enough resources to make everybody
1277
01:07:55.039 --> 01:07:57.199
have a comfortable life. There's more than enough food that
1278
01:07:57.239 --> 01:08:00.880
we can produce, there's more than enough shelter. The capacity
1279
01:08:00.880 --> 01:08:03.840
that humans have to take care of everybody, and to
1280
01:08:04.159 --> 01:08:08.519
take collective action against nuclear weapons, against global warming, all
1281
01:08:08.559 --> 01:08:12.559
of that is there. The opportunity is incredible, but we
1282
01:08:12.599 --> 01:08:16.279
need this consciousness shift. And I think that psychedelic in
1283
01:08:16.399 --> 01:08:19.920
the proper context can play a major role in this
1284
01:08:20.079 --> 01:08:22.840
sort of consciousness shift, but it's not the only way.
1285
01:08:22.920 --> 01:08:25.199
So I was at a meeting the other day and
1286
01:08:25.399 --> 01:08:29.279
somebody was debating is MDMA a psychedelic? They're like, oh,
1287
01:08:29.520 --> 01:08:31.560
And they said, oh, no, MDMA is not a psychedelic.
1288
01:08:31.720 --> 01:08:34.680
You know, only the classic psychedelics that dissolve your ego, LSD,
1289
01:08:34.720 --> 01:08:37.159
psilocybin and things like that are And I said, no.
1290
01:08:37.640 --> 01:08:40.560
You know what I've been doing to try to normalize
1291
01:08:40.560 --> 01:08:44.800
psychedelics in people's minds is to broaden the definition of psychedelic,
1292
01:08:44.960 --> 01:08:48.720
which it was meant to mean mind manifesting, and so
1293
01:08:49.479 --> 01:08:54.199
hyperventilation is psychedelic dreams or psychedelic. So you know, all
1294
01:08:54.239 --> 01:08:56.960
of this is and we all have some connection to
1295
01:08:57.000 --> 01:08:59.680
our dreams or you know, just the thought that through
1296
01:08:59.720 --> 01:09:02.279
all you're breathing, you're going to have a psychnolic experience.
1297
01:09:02.760 --> 01:09:06.039
What it means is it's in ourselves. It's not this
1298
01:09:06.199 --> 01:09:08.840
these experiences in this drug. And it's also something you
1299
01:09:08.880 --> 01:09:11.199
can get from looking at Earth from space. So I
1300
01:09:11.239 --> 01:09:15.319
think that this consciousness shift is necessary for human survival,
1301
01:09:15.880 --> 01:09:17.880
and whether we're going to make it or not is
1302
01:09:17.960 --> 01:09:21.159
really uncertain. You know, people are talking about AI is
1303
01:09:21.199 --> 01:09:23.479
going to destroy the world, you know, but we are
1304
01:09:23.520 --> 01:09:26.359
the ones that program AI. So it's not AI destroying things,
1305
01:09:26.399 --> 01:09:29.119
it's us, if that's what happens. I do think we
1306
01:09:29.239 --> 01:09:32.680
need this consciousness shift. And when I well, I'll say
1307
01:09:32.680 --> 01:09:35.680
Albert Off. Albert Einstein had this great quote as well,
1308
01:09:36.119 --> 01:09:38.960
which was the splitting of the atom has changed everything
1309
01:09:39.119 --> 01:09:42.720
except our mode of thinking, and hence we drift towards
1310
01:09:42.800 --> 01:09:47.039
unparalleled catastrophe. What shall be required if mankind is to
1311
01:09:47.159 --> 01:09:50.000
survive as a whole new mode of thinking. Now, what
1312
01:09:50.159 --> 01:09:52.479
is that new mode of thinking? I think it's collective,
1313
01:09:52.640 --> 01:09:55.680
it's mystical, it's how we're all in it together. That's
1314
01:09:55.720 --> 01:09:58.399
the consciousness shift that we need, and psychedelics can help
1315
01:09:58.439 --> 01:09:58.680
with that.
1316
01:09:59.119 --> 01:10:01.760
Yeah, we clearly seem to be a real inflection point.
1317
01:10:01.840 --> 01:10:05.000
Maybe decades or centuries earlier a shift and consciousness would
1318
01:10:05.000 --> 01:10:08.000
have been nice, but now it seems somewhat existential that
1319
01:10:08.079 --> 01:10:11.199
we need this now to address the very complex problems
1320
01:10:11.199 --> 01:10:14.640
we're facing. And so the psychaic experience in whatever form,
1321
01:10:14.680 --> 01:10:18.479
whether it's through breath work or nature experiences or psychaic medicine,
1322
01:10:18.520 --> 01:10:21.560
seems some kind of transpersonal experiences seems to be so
1323
01:10:21.760 --> 01:10:26.159
necessary to create that collective individual and collective shift and consciousness.
1324
01:10:26.399 --> 01:10:30.000
Maybe just one last question I'd have, So if the
1325
01:10:30.119 --> 01:10:34.279
FDA had approved MDMA, you know, my question is kind
1326
01:10:34.279 --> 01:10:36.680
of I'm in a narrative bit, but where would we
1327
01:10:36.720 --> 01:10:39.560
be now and what would we be doing? And you know, visioning,
1328
01:10:39.600 --> 01:10:41.760
hoping whether the way it works out. They don't just
1329
01:10:41.880 --> 01:10:44.199
narrowly approve just the drug and it doesn't some of
1330
01:10:44.239 --> 01:10:46.680
the dangers of how lycos and FDA may approve it,
1331
01:10:46.680 --> 01:10:48.199
but hopefully if it works out the way you would
1332
01:10:48.239 --> 01:10:50.000
like it to work out in three years and the
1333
01:10:50.039 --> 01:10:53.119
outcome you were hoping for now occurs. But let's say
1334
01:10:53.159 --> 01:10:55.800
it had occurred. One of the challenges is to roll
1335
01:10:55.800 --> 01:10:59.960
this out in any way that's equitable, it's distributable, that's accessible,
1336
01:11:00.159 --> 01:11:03.439
it's not too expensive that insurance will cover, that can
1337
01:11:03.479 --> 01:11:07.279
be widely distributed. And so one of the one of
1338
01:11:07.319 --> 01:11:09.960
the suggestions has been group therapy as opposed to just
1339
01:11:10.039 --> 01:11:13.199
individual therapies. And you know, and then at what level
1340
01:11:13.239 --> 01:11:16.039
of licensures required to be a guide? And you know,
1341
01:11:16.079 --> 01:11:18.520
in the many of the clinical trialogy had two licensed
1342
01:11:18.520 --> 01:11:22.640
clinicians there. That would be extraordinarily expensive. So what would
1343
01:11:22.680 --> 01:11:24.960
you what do you envision would be happening right now
1344
01:11:25.039 --> 01:11:27.439
if it had been approved now and over the next
1345
01:11:27.479 --> 01:11:29.960
six months to a year, And what would you envisioned
1346
01:11:30.000 --> 01:11:30.920
that needs to happen?
1347
01:11:30.920 --> 01:11:35.560
Then? Well, okay, so let's say fdaight approved. One of
1348
01:11:35.600 --> 01:11:38.359
the first things that would have been done and should
1349
01:11:38.359 --> 01:11:41.399
have been done allowed to and this is so clearly commercial,
1350
01:11:42.079 --> 01:11:46.520
is a dose response safety study of people on SSRIs
1351
01:11:46.560 --> 01:11:50.800
with PTSD giving them higher doses of MDMA. So we
1352
01:11:50.880 --> 01:11:56.000
require we licos maps. The research with MDMA requires people
1353
01:11:56.119 --> 01:12:00.439
to taper off of their psychiatric medications. It's true that
1354
01:12:00.479 --> 01:12:02.520
they blunt the effect of MDMA. There's a lot of
1355
01:12:02.600 --> 01:12:06.600
underground evidence and anecdotal reports and some theoretical reasons to
1356
01:12:06.600 --> 01:12:09.479
think that when you do higher doses of MDMA you
1357
01:12:09.640 --> 01:12:13.159
overwhelm the blunting effects, but you don't get serotonin syndrome.
1358
01:12:13.600 --> 01:12:17.239
So that's just from a purely commercial point of view.
1359
01:12:17.239 --> 01:12:20.279
There's loads of people that don't really want to taper
1360
01:12:20.279 --> 01:12:23.640
off their medicines in order to get treated for PTSD
1361
01:12:23.680 --> 01:12:25.880
with MDMA. Yeah, I mean you can give to people
1362
01:12:26.000 --> 01:12:28.439
on their medicines more and more. It's sturning out psilocybein
1363
01:12:28.520 --> 01:12:31.039
you can give to people on their medicines. That's one thing.
1364
01:12:31.560 --> 01:12:33.359
Another thing that would be happening, and I'll get to
1365
01:12:33.399 --> 01:12:36.880
the group therapy, But the FDA has blocked licos and
1366
01:12:37.039 --> 01:12:41.199
maps before that from studying adolescence with PTSD or people
1367
01:12:41.319 --> 01:12:44.479
under eighteen with PTSD. So far, it's only been eighteen
1368
01:12:44.560 --> 01:12:47.000
or over, and if it was approved, it was only
1369
01:12:47.000 --> 01:12:50.159
approved for eighteen or over. However, the FDA indicated that
1370
01:12:50.239 --> 01:12:53.119
if they would approve it, then they would require studies
1371
01:12:53.119 --> 01:12:56.720
and adolescents, which are called pediatric studies. I think that's
1372
01:12:56.800 --> 01:12:59.439
really really important. The closer you can treat people to
1373
01:12:59.479 --> 01:13:03.359
the trauma, the less damage there is, the more benefit
1374
01:13:03.399 --> 01:13:06.000
there is. And so I think there would be adolescent
1375
01:13:06.039 --> 01:13:09.920
studies happening at FDA. Happened as far as group therapy now,
1376
01:13:10.479 --> 01:13:14.119
there is this incredible project that's being developed in Israel
1377
01:13:14.239 --> 01:13:17.520
for group therapy, for exploring that. There's a study the
1378
01:13:17.680 --> 01:13:22.760
Dutch well Accually, the Australian government is now funding research
1379
01:13:22.880 --> 01:13:27.079
with two hundred people in group therapy with climate related
1380
01:13:27.159 --> 01:13:30.880
PTSD from flood in England. They already going to do
1381
01:13:30.960 --> 01:13:34.640
two therapists for three people. And at the Portland Oregon
1382
01:13:34.720 --> 01:13:38.399
VA there is group therapy taking place right now and
1383
01:13:38.399 --> 01:13:41.680
it's four therapists for six people with PTSD and there
1384
01:13:41.720 --> 01:13:44.760
they get one MDMA session individually and then a group session.
1385
01:13:45.199 --> 01:13:48.000
In the Israel study, i'll be group sessions in the
1386
01:13:48.079 --> 01:13:51.039
Australian study. I'm not sure, so I think there would
1387
01:13:51.079 --> 01:13:53.359
be even more work, but there is some work with
1388
01:13:53.720 --> 01:13:57.079
group therapy. The other thing is that the FDA is
1389
01:13:57.079 --> 01:13:59.199
a signal. If they approve it, it's a signal to
1390
01:13:59.239 --> 01:14:01.800
countries all over the world that it's okay. So our
1391
01:14:01.840 --> 01:14:05.800
international global humanitarian projects are made more difficult now because
1392
01:14:05.920 --> 01:14:08.479
FDA did not say approval. So just to give you
1393
01:14:08.560 --> 01:14:13.279
an example, in Armenia, which has leftover terrible laws from Russia.
1394
01:14:13.319 --> 01:14:17.039
In Ukraine, the story is similar. You cannot do research
1395
01:14:17.079 --> 01:14:19.960
with drugs and Schedule one. Now. In Ukraine they're going
1396
01:14:20.039 --> 01:14:22.920
to have a meeting in November. They have such PTSD
1397
01:14:23.000 --> 01:14:26.039
problems because of the Russian invasion that they're willing to
1398
01:14:26.079 --> 01:14:30.600
think about different modifications of their existing systems. So there's
1399
01:14:30.600 --> 01:14:32.560
going to be a meeting in November and Ukraine about
1400
01:14:32.680 --> 01:14:36.600
ending this prohibition of research with MDMA or psilocybin or
1401
01:14:36.640 --> 01:14:38.960
other schedule on drugs. But if FDA said yes, it
1402
01:14:38.960 --> 01:14:42.239
would be rescheduled and then that would be easy. Armenia
1403
01:14:42.600 --> 01:14:44.359
he can through some stuff with Schedule one, but I
1404
01:14:44.359 --> 01:14:46.840
haven't heard about regal efforts to try to change that.
1405
01:14:47.479 --> 01:14:52.319
Everywhere we go in Somaliland, Rwanda, Kenya, South Africa. We're
1406
01:14:52.359 --> 01:14:55.119
going to do a training of therapists in Abudhabi. In Dubai.
1407
01:14:55.600 --> 01:14:58.239
There's an enormous amount of PTSD in the Arab world
1408
01:14:58.239 --> 01:15:01.680
as well, and we want to treat everybody healing for all.
1409
01:15:02.239 --> 01:15:05.319
But now that FDA didn't say yes, and maybe a
1410
01:15:05.319 --> 01:15:08.000
while before, the people in Abudawi Dubai ready for us
1411
01:15:08.000 --> 01:15:10.399
to do that, to do trainings in the start work.
1412
01:15:10.439 --> 01:15:13.439
A lot of people are ready to go second after FDA,
1413
01:15:13.920 --> 01:15:16.640
but they don't want to go first. So that's the
1414
01:15:16.680 --> 01:15:19.279
real setback from FDA is that if they would have
1415
01:15:19.319 --> 01:15:22.920
gone first, then so many other countries would have gone second,
1416
01:15:23.000 --> 01:15:25.239
and we could have but we will still be able
1417
01:15:25.239 --> 01:15:27.560
to do things around the world. But I do think
1418
01:15:27.600 --> 01:15:29.760
that you're putting your finger on group therapy as I
1419
01:15:29.800 --> 01:15:33.279
think the key factor for access. And I just heard
1420
01:15:33.319 --> 01:15:36.000
a story this morning from some of the Israeli teams
1421
01:15:36.520 --> 01:15:39.239
that you know, I've always felt that individual therapy is
1422
01:15:39.279 --> 01:15:42.079
going to be more effective than group therapy, but that
1423
01:15:42.159 --> 01:15:46.199
the group integration process, you'd be so supportive that that
1424
01:15:46.279 --> 01:15:48.399
can kind of make up for it. But what I
1425
01:15:48.439 --> 01:15:50.880
heard from one of the Israelis this morning was that
1426
01:15:50.960 --> 01:15:54.479
they saw a group session that they thought was so
1427
01:15:54.800 --> 01:15:58.119
profound for the people in the group that they're questioning
1428
01:15:58.159 --> 01:16:02.159
whether group therapy is inferior to individual therapy. They think
1429
01:16:02.159 --> 01:16:04.840
it might even be as good or better in certain circumstances.
1430
01:16:05.319 --> 01:16:07.800
So I think that is the main area of research
1431
01:16:07.840 --> 01:16:11.920
that is still happening even though FDA to know. But
1432
01:16:12.079 --> 01:16:15.560
what is more difficult is the global humanitarian projects and
1433
01:16:15.640 --> 01:16:18.119
what is not happening is the pediatric studies or the
1434
01:16:18.520 --> 01:16:22.119
Bocherswant safety study. With people on SSRIs, well, we'll hope
1435
01:16:22.199 --> 01:16:24.479
for the best with how this rolls out with the FDA.
1436
01:16:24.640 --> 01:16:26.960
And thank you so much for the incredible work you've
1437
01:16:26.960 --> 01:16:31.279
been doing for many decades. This has been incredibly educational, illuminating.
1438
01:16:31.279 --> 01:16:32.319
This will thank you so much.
1439
01:16:32.680 --> 01:16:35.000
Thank you for having me because another thing that is
1440
01:16:35.079 --> 01:16:38.319
so clear with the FDA rejection is that we need
1441
01:16:38.359 --> 01:16:41.319
more public education and that's I want to thank you
1442
01:16:41.359 --> 01:16:43.319
for trying to help you do more of that.
1443
01:16:43.319 --> 01:16:47.119
Absolutely, absolutely, thank you, be well. Thank you for joining
1444
01:16:47.199 --> 01:16:51.319
me on the Radical Responsibility Podcast. Remember, real change happens
1445
01:16:51.319 --> 01:16:54.439
when we commit to our growth, face our challenges with compassion,
1446
01:16:54.560 --> 01:16:58.039
and stay open to transformation. If you found this episode helpful,
1447
01:16:58.279 --> 01:17:00.720
I encourage you to subscribe and help us spread the
1448
01:17:00.760 --> 01:17:04.720
message of healing and personal empowerment. Stay grounded, stay present,
1449
01:17:04.920 --> 01:17:05.920
and stay true to you.
1450
01:17:06.199 --> 01:17:06.680
Take care
1
00:00:02.600 --> 00:00:06.519
Welcome to the Radical Responsibility Podcast. I'm doctor Fleet Mall
2
00:00:06.679 --> 00:00:09.119
and I'm excited to guide you on a journey of
3
00:00:09.199 --> 00:00:12.880
authentic transformation. In each episode, I'll bring you insights from
4
00:00:12.960 --> 00:00:18.280
leading experts to explore trauma recovery, mindfulness practices, positive psychology,
5
00:00:18.320 --> 00:00:23.000
and innovative breakthroughs in health, wellness and life optimization. This
6
00:00:23.039 --> 00:00:26.640
is a space for real conversations that inspire meaningful change,
7
00:00:26.719 --> 00:00:29.600
helping you find alignment with the person you are always
8
00:00:29.600 --> 00:00:35.359
meant to be. Let's get started. My name is doctor
9
00:00:35.359 --> 00:00:37.640
Fleet Mall, your co host for this session, and I'm
10
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really thrilled to be here today with none other than
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Rick Doblin. Welcome, doctor Doblin.
12
00:00:42.560 --> 00:00:44.759
Think that's a pleasure to be here with you today.
13
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Oh, it's really great to have you and been looking
14
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forward to this conversation. So maps under your direction has
15
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really been a pioneering force in psychoic research and the
16
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efforts to overturn what happened back in the seventies with
17
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the schedule of all the psychic medicines as schedule on
18
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drugs having no therapeutic or medical value, and your efforts
19
00:01:06.920 --> 00:01:10.840
led to the clinical studies on MDMA and psilocybin and others,
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and recently the FDA elected not to recommend rescheduling of
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MDMA at this time based on the advice of their
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or the recommendations from their advisory committee. So I'm curious
23
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about your thoughts on that. Where things stand now and
24
00:01:26.359 --> 00:01:29.879
given the complexities of the overall FDA approval process and
25
00:01:30.120 --> 00:01:34.840
dea rescheduling, you know, strategies for seems like it's something
26
00:01:34.879 --> 00:01:37.239
that's inevitable. But this is clearly that I would imagine
27
00:01:37.239 --> 00:01:39.280
a bit of a setback. So where are we and
28
00:01:39.319 --> 00:01:40.280
where do we go from here?
29
00:01:40.519 --> 00:01:43.439
Well, I do believe it's inevitable because I do believe
30
00:01:43.519 --> 00:01:47.079
that even the data that we have was considered by
31
00:01:47.079 --> 00:01:50.719
the ft advisory committee meaning to be in the advocate
32
00:01:50.760 --> 00:01:53.680
to demonstrate safety, your efficacy. They issued their report on
33
00:01:53.760 --> 00:01:57.719
June fourth. The Dutch State Committee on MBMA was the
34
00:01:57.840 --> 00:02:02.040
Dutch equivalent of the FDA committee, except for the fact
35
00:02:02.599 --> 00:02:06.200
that it had actual subject matter experts who knew more
36
00:02:06.239 --> 00:02:09.800
about psychedelics and psychedelic research than the advisory people did
37
00:02:10.199 --> 00:02:13.120
for the FDA. They spent about a year reviewing the
38
00:02:13.199 --> 00:02:17.240
data and they published a book length report about their findings,
39
00:02:17.639 --> 00:02:19.879
and they came to the opposite conclusion of the FDA
40
00:02:19.879 --> 00:02:24.159
Advisory Committee. They said that efficacy was proven, safety was proven,
41
00:02:24.240 --> 00:02:27.759
and since LEGOS had pulled out of Europe after supporting
42
00:02:27.800 --> 00:02:31.039
some early pilot studies in phase two to prepare therapists
43
00:02:31.120 --> 00:02:34.840
phase three, which LEGOS decided not to do, pulled out
44
00:02:34.879 --> 00:02:38.800
of Europe withdrew their application. The Dutch committee said that
45
00:02:39.360 --> 00:02:42.240
because efficacy and safety are proven, because there's such a
46
00:02:42.240 --> 00:02:46.280
major una medical need, there should be immediate implementation of
47
00:02:46.319 --> 00:02:49.800
what they called naturalistic studies, which is basically real world
48
00:02:49.840 --> 00:02:53.240
that evidence compassionate use where therapists can give MD get
49
00:02:53.240 --> 00:02:56.159
made PTSD patients, you do some measurements before and after,
50
00:02:56.680 --> 00:02:59.400
but there's no control group. So in that sense it's
51
00:02:59.439 --> 00:03:02.120
like real world evidence, and so that's what's being discussed
52
00:03:02.159 --> 00:03:05.759
to really set up now in the Netherlands. So I
53
00:03:05.800 --> 00:03:08.919
think that we need to look at how did two
54
00:03:09.080 --> 00:03:12.800
different bodies come to two completely different conclusions within two
55
00:03:12.879 --> 00:03:15.560
days of each other. And I think the answer is
56
00:03:15.599 --> 00:03:18.759
that the FT Advisory Committee really was composed of people
57
00:03:19.240 --> 00:03:23.599
that really didn't understand the data, the research. They were
58
00:03:23.639 --> 00:03:26.800
really much more influenced by media and public opinion, and
59
00:03:26.879 --> 00:03:31.080
for that Mico's had adopted a traditional approach, which they
60
00:03:31.120 --> 00:03:35.080
called the quiet period, which they wanted no interaction with media,
61
00:03:35.199 --> 00:03:38.960
no interaction with ousay agencies, not even blocking me from
62
00:03:39.000 --> 00:03:43.759
even responding to criticisms about the therapeutic approach in scientific journals.
63
00:03:44.240 --> 00:03:47.479
So I think it was basically a situation where we
64
00:03:47.719 --> 00:03:52.039
had people on the advisory committee who didn't really understand
65
00:03:52.560 --> 00:03:56.080
the science, were much more influenced by the media than
66
00:03:56.080 --> 00:03:57.919
they were by the briefing package that they got from
67
00:03:57.960 --> 00:04:03.400
the FDA, and who really didn't understand so much. So
68
00:04:03.439 --> 00:04:05.439
for example, and then I'll get to where do we
69
00:04:05.479 --> 00:04:07.879
go from here, which is really the key question. The
70
00:04:07.960 --> 00:04:12.240
advisory committee said that one big concern of theirs was
71
00:04:12.439 --> 00:04:16.399
this idea of functional and blinding. And you know, Lekos
72
00:04:16.519 --> 00:04:21.319
has hired David Hoff, who led the Spravado effort to
73
00:04:21.319 --> 00:04:23.839
make Spravado into a medicine for Johnson and Johnson for
74
00:04:24.519 --> 00:04:27.680
s kennemine spravado, and what he said in an interview
75
00:04:27.759 --> 00:04:32.920
in PSYCHEDELICALFA that in his experience, even schizophrenia studies are
76
00:04:32.959 --> 00:04:36.480
not really blinded because the drugs that are tested to
77
00:04:36.480 --> 00:04:39.639
have such a strong side effect profile that the researchers
78
00:04:39.680 --> 00:04:42.040
and the patients can tell whether they got the placeba
79
00:04:42.560 --> 00:04:45.600
or whether they got the active drug. Tom Lawfren, who
80
00:04:45.839 --> 00:04:49.959
was the former director of Psychiatry Products, said something similar
81
00:04:50.000 --> 00:04:53.199
that even in SSRI studies where you think it's a pill,
82
00:04:53.199 --> 00:04:55.519
it doesn't have like a psychedelic a fact, you need
83
00:04:55.560 --> 00:04:57.959
to take it for weeks or a month sometimes before
84
00:04:58.000 --> 00:05:01.399
it really changes one smood. That would be easy to blind.
85
00:05:01.439 --> 00:05:03.839
But he said again no, that the side effect profile
86
00:05:03.959 --> 00:05:06.959
of these drugs makes it so that a double blind
87
00:05:07.040 --> 00:05:11.519
is a theoretical approach, but in practice it fails more
88
00:05:11.560 --> 00:05:16.000
often than it succeeds. And we negotiated fully with the
89
00:05:16.079 --> 00:05:20.279
FDA in twenty seventeen, twenty sixteen of VER twenty ninth,
90
00:05:20.519 --> 00:05:22.959
twenty sixteen, as we got permission to go to Phase three.
91
00:05:23.240 --> 00:05:26.240
Because of the double blind and other issues, I decided
92
00:05:26.279 --> 00:05:29.639
to elect to go through a special protocol assessment process
93
00:05:29.680 --> 00:05:32.759
that took eight months, and we negotiated every aspect of
94
00:05:32.800 --> 00:05:36.920
the design with FDA, and we discussed intensively how to
95
00:05:36.959 --> 00:05:42.120
address functional unblinding, and the solution that the FDA chose
96
00:05:42.560 --> 00:05:47.040
was MDMA with inactive lacibo versus MDMA with full dose
97
00:05:47.199 --> 00:05:50.399
I mean therapy with inactiveacebo therapy with full dose MDMA.
98
00:05:50.959 --> 00:05:54.439
And the reason that my dissertation, which I got from
99
00:05:54.480 --> 00:05:57.040
the Kinny School Government Heart two thousand and one, focused
100
00:05:57.079 --> 00:05:58.920
a lot on the double blind issue, and I thought
101
00:05:58.920 --> 00:06:01.000
the solution was going to be therapy with low dose
102
00:06:01.079 --> 00:06:04.480
MDMA versus therapy with full dose. And the challenge was
103
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going to be, what's the dose that's high enough to
104
00:06:07.279 --> 00:06:10.199
start causing confusion. Microdose doesn't work because you don't really
105
00:06:10.240 --> 00:06:13.959
notice it. That's the definition of microdosing just has several effects.
106
00:06:14.160 --> 00:06:16.720
So what's the dose that's high enough to start saying
107
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to people, well, maybe this is a full dose, but
108
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not so high that it has so much therapeutic potential
109
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that you'll never be able to tell the difference between
110
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the two groups. And what we discovered in sixteen years
111
00:06:27.000 --> 00:06:29.839
of phase two studies starting in two thousand was that
112
00:06:29.879 --> 00:06:32.519
the lower doses did produce blinding, and I'm talking about
113
00:06:32.560 --> 00:06:36.480
twenty five milligrams thirty forty fifty were more likely to
114
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be confused with fuller dose, But to our surprise, they
115
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had an anti therapeutic effect, meaning they activated people, but
116
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they didn't reduce the fear enough and they made them uncomfortable.
117
00:06:48.839 --> 00:06:51.680
So by anti therapeutic, I mean they still got better
118
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because it's with the therapy, but they didn't get as much.
119
00:06:54.759 --> 00:06:57.240
Those people that got low dose MDMA did not make
120
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as much progress as those people that got therapy without
121
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any MDMA at all, with inactive placebo. So we went
122
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to the FDA and we said, hey, you know, we
123
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can give you blinding, but you're going to make it
124
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easier for us to find a difference between the two groups.
125
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The other thing we discovered in phase two, to our surprise,
126
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was that the that's tipping point you could say, to
127
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where it went from making people nervous to being very
128
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therapeutic was lower than we thought it was. Seventy five
129
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milligrams did great for people, and so in one study
130
00:07:28.319 --> 00:07:30.759
that we had veterans, firefighters, and police officers, it was
131
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thirty milligrams for one group, seventy five for another, and
132
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one twenty five milligram, and the seventy five milligram actually
133
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did better than the one twenty five. Now, when you randomize,
134
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not everything is equal, So there was more depression associated
135
00:07:43.600 --> 00:07:46.040
with the PTSD in the one twenty five group than
136
00:07:46.079 --> 00:07:48.319
in the seventy five group. That may have contributed to
137
00:07:48.519 --> 00:07:51.720
the difficulties of treating the people in the one twenty five,
138
00:07:51.759 --> 00:07:56.079
but in any case, seventy five was really very profoundly effective.
139
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So we went to the FDA and said, you know,
140
00:07:58.439 --> 00:08:00.399
we'll give you blinding, but the real quest question is
141
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if you can do this with therapy, why I bother
142
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out a drug. And then the other thing we said
143
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is that the safety profile is better understood and better
144
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characterized with inactive placebo, because if you have therapy with
145
00:08:12.720 --> 00:08:16.480
inactive placebo, whatever happens, you know is due to severe
146
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or monitor severe PTSD. In therapy. We had one woman
147
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try to kill herself twice in the study. Another woman
148
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had severe suicidal aviation checked herself into the hospital not
149
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to kill herself, and both were in the placebo group
150
00:08:29.439 --> 00:08:31.879
meaning MDMA with inactive placebo. If they had been in
151
00:08:31.879 --> 00:08:33.679
a group that had gotten twenty five or thirty or
152
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forty milligrams of MBMA, people would say, oh, maybe that
153
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was the MDMA made her uncomfortable. That's not background. Now
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when we talk about background factors for treating PTSD. The
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VA did a study, took him around six years, published
156
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it two years ago nine hundred and sixteen veterans comparing
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prolonged exposure with cognitive processing therapy, the two main non
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drug therapies used by the FDA to treat PTSD. Fifty
159
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percent of the people dropped out of the study because
160
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the therapy was retraumatizing. Half the people didn't even make
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it through the study. So that just shows you how
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difficult it is to normally treat people with PTSD with
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any of these normal standard therapies. So FDA had other
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reasons as well. Dutch committee, as I said, was the opposite.
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So where do we go from here?
166
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It just fell open up for just a minute a
167
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couple because I know there were a couple other objections
168
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raised by the TRAM.
169
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Yeah, I'd be glad to go through them.
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And we could just mention those briefly. The one that
171
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there was somewhere in the history of the clinical trials
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there was one incident of inappropriate behavior on the part
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of a sitter or a guide or a therapist, which
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happens in psychotherapy all the time. So not that it
175
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should and there's regulations do you have institutional repercussions, but
176
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it does happen, So isolating that is being a significant
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It seems like they gave way too much significance to that.
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Let me come out on that first switch totally right,
179
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because that happened in twenty sixteen. We started in two thousand.
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We've worked with around four hundred people. So the fact
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that a therapist would engage in sexually by definition and
182
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sexually usive relationship of a patient after the MDMA sessions
183
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were over one time out of hundreds and hundreds and
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00:10:06.320 --> 00:10:10.120
hundreds eight years ago, yeah, that should never have happened.
185
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One is too many. But this idea that this is
186
00:10:13.279 --> 00:10:17.159
a rampant, you know, process and everybody who goes through
187
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therapy with MDMA is vulnerable, and that I'm you know,
188
00:10:20.320 --> 00:10:23.600
I was called the cult leader on par with scientology
189
00:10:23.600 --> 00:10:28.000
and nexting I mean, massive exaggerations. But my wife helped
190
00:10:28.039 --> 00:10:30.720
me to understand this a little bit better, and she
191
00:10:30.799 --> 00:10:32.919
said that a lot of women are harrassed, are raped,
192
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or you know, it's not an uncommon thing for a
193
00:10:35.679 --> 00:10:38.360
woman to encounter this. So when this was raised at
194
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the advisory committee in such a way that was so powerful,
195
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the women on the advisory committee meeting were probably reminded
196
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of some of their own experiences and that became more
197
00:10:49.440 --> 00:10:52.120
emotionally salient to them than the fact that it happened
198
00:10:52.159 --> 00:10:55.200
one time eight years ago out of like four hundred people.
199
00:10:55.399 --> 00:11:00.799
So I think it was completely overblown in the implications
200
00:11:00.840 --> 00:11:04.279
for the therapy. And at the same time, what about
201
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people to commit suicide from PTSD reward ratio.
202
00:11:08.039 --> 00:11:10.679
And as you said, one time of incidence of sexual
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abuse one time is too many, And this is the
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human realm, and these things happen. We try to prevent
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them as much as we can. But purely scientific based
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one out of that many eight years ago, it seems overlyweighted,
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to say the least.
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Well, let me just have it. In the Spravado studies
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for depression, some people committed suicide. We didn't have any
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of that. Not a single person in the MDMA group
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attempt at suicide.
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Maybe this is a minor out anonymous characterizer, but they
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pointed out that there was some they felt underreporting of
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not necessarily negative experiences, but the way preeople were characterized
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as having sort of positive trips so to speak, versus
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somewhat negative or something, And there was some they felt
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there was some underreporting of that. Am I characterizing that correctly?
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Yeah, this idea that people might pass through Now, let
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me just say ninety percent of the people had suicidal
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aviation and had serious suicidal ideation. Roughly a third had
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positive behavior, which means they attempted suicide or they bought
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a rope and thought about hanging them cells.
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We didn't do it prior to the study.
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I mean prior to the study. And once you look
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at this population, then this idea that sometimes people might
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go through a process where they're reliving some of their
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prior suicidal behaviors or ideations. And so the claim was, oh,
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every time that somebody felt suicidal, that was not reported
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as a adverse event. Now I don't believe that's the case.
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I think that there was a real good reporting of
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the adverse events. But the FDA, the letter that the
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FDA sent to licos to complete response letterlecos, I think
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has not made that public. But I think if they did,
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that would be helpful for people and they see whether
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FDA really decided that there was any of this under reporting.
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I don't think that's the case that the other party
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you said about the positive event adverse events. So the
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idea is that if you feel, you know is known
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as the love drug, and you know, people can feel
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self compassion, they can feel joy. A lot of people have,
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you know, particularly traumatized people have not felt joy for
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a long time. So what the FDA said is that
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all these moments of joy or ecstasy or you know,
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should have been recorded as a positive adverse event because
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it could lead to people, you know, taking MVMA outside
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of the therapeutic setting and becoming addicted to MBMA or
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addicted to cocaine. That's somebody at the advisory committee talked
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about how you're going to give people MBMA and before
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you know, if they're going to do cocaine, I mean
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at reads. So I think that it's true though that
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Lecos did not gather this kind of information. Again, it's
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like these are intermedia signals of something else. The something
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else is it is becoming dependent on MBMA. So there
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was no evidence that anybody became dependent on MBMA or
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you know, and there was evidence that people drink alcohol lass.
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You know, once you work through people's traumas, they have
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less of a need to ass escape and drug abuse.
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You know, there was a study in England with MDMA
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for alcohol use disorder, and most of the people in
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the study were running away from traumas and you help
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them work through it. They don't need so I think,
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actually MDMA systs the therapy will be helpful for addiction,
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is not going to create addiction. And yet FDA was like, oh,
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we don't have enough information on euphoria or other kind
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of positive adverse events that, like I was, probably should
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have gathered that, but they didn't.
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Well it's really interesting, I even help they're defining adverse effects,
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both positive and negative, because averse effects can be very
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much part of the therapeutic process.
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Yes, exactly, they're computer therapy. So when somebody goes through,
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there's suicidal ideations. So this is a different kind of
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a story, but this was someone that was, you know,
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going through MDMA therapy in an underground way. I heard
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this story and they were talking about and earlier. Actually
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this is somebody who had an LSD trip that was
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really difficult and then this is now forty years later,
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doing MDMA therapy to deal with the trauma of the
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LSD trip. And during the LSD trip, as the person
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was reliving it, they were talking about how, you know,
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they felt suicidal and that's why it was so problematic.
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And so when you're doing the therapy. You're revisiting these thoughts,
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but you're not like captive to them. It's like, oh,
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you know, yes, I was suicidal at that time. Does
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that feel right now? Did that feel right then? But
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you could look at it from the outside. Oh, now
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he's got suicidal thoughts and that's an adverse event, and
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now this guy's a danger of committing suicide again. He
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actually did try to kill himself during the LSD trip
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and later is trying to four years later, still trying
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to work through it. And it was kind of a
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breakthrough with the MDMA. Yeah, I think the FDA and
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others confused, what's the therapeutic process with adverse events.
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It's be interesting when the FDA looks at trials on
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psilocybin and other classic psychatic psilocybin or even LSD and others,
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because people as part of the therapytic process, people can
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have some really pretty difficult journeys revisiting even unconscious memories
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and traumas and so forth, and they can have extraordinary
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trans personal experiences that are part of the therapeutic back
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but might be considered you know, even beyond the uphoi
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as someone experiences an MDA, so it's kind of hard
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the way they're framing it, how you can almost ever
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get there.
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People at the advisor community said, oh, my god, can't
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trust the results. Forty percent of the people had done
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MDMA before they got into the study. Well, then they
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said they're biased. Now these people liked MDMA or else
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they wouldn't volunteered, they should have fewer side effects, and
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they should get better results because they're all biased. Well
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that's something to raise. However, in the debate of the
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discussions the formal Special Protocol assessment process, the FDA didn't say,
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don't enroll people with prior experience with MDMA. But in
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any case, those people that had prior experience with MDMA
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did not show greater benefits than those people that had
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never done MDMA, and those people that had done prior
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MDMA didn't show fewer side effects than the sixty percent.
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And I think the most important thing to say is
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that these people had done MDMA and they still had PTSD.
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The healing is not in the drug, it's in the
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relationship you have with the drug in a therapeutic context.
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So that was a big criticism. Oh, forty percent of
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your people at prior experience with MDMA, and theoretically we think,
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oh my god, they're biased and they're going to have
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better outcomes in your side effects. But when you look
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at the data, it wasn't that way at all, and
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you got that was this whole big confusion. And then
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the other a bunch of these people at one of
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them said, I've kind of voted against this in part
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because your studies were not diverse. Well, the second phase
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three study had fifty percent non white people. I mean,
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they totally didn't even understand what they were talking about.
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The other thing I should add is that, and this
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relates now back to the unblinding, is that the agreements
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we had with the FDA in twenty seventeen to conclude
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the Special Protocol assessment with a legal agreement letter where
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with people at the FDA who had left the agency afterwards,
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and so the new director of Psychiatry Products was deputy director,
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but she was not director when we made these agreements,
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and so we now have a changing of the guard
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to more conservative people. But the agreements that you make
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should not be with individuals, they should be based with
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the organization. These are agreements with FDA. The FDA changed
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the goal posts all of a sudden said, oh, this
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design that we chose to do inactive PLACEIBO, now we
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don't believe the results of it. It's completely inappropriate for
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them to do that. And we thoroughly discussed functional and blinding,
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and what the FDA said was that there's two main
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ways to deal with this. When there is functional on blinding,
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which there is, as I said, in many studies, but
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also in psychedelics, in cannabis, and also all psychotherapy studies
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are not blinded. You know, you can't blind some mean
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what kind of psychotherapy they're receiving, but the idea that
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people were somehow or other, you know, biased. The FDA
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said that random assignment is the first thing. You want
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everybody to similarly motivated, So that's easy to do. But
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then the other thing that they said is that you
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want independent raiders to evaluate the outcomes. The outcomes should
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not be evaluated by the research team or by the therapists.
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And so we had a very robust system of independent raiders,
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over twenty raiders, mostly trained by the Boston VA, with
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monthly interrator reliability tests where they'd all watch a videotape
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of someone going through a PTSDD interview for the clinician
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administered PTSD scale. So we had independent raiders that were
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blinded of the condition and we had random assignment and
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so those Now the other thing to say, which somehow
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never got discussed, is that twenty five percent of the
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people who got placebo either thought they had MDMA or
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were unsure. So that's not so bad blinding. Twenty five
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percent of the people who got the placebo couldn't tell
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or thought they had MDMA because they were in a
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situation of work difficult issues. They were supported with music.
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Now it's not the other way around. So it's like
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ninety five percent of the people that got MDMA knew
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they got MDMA. But when you look at the placebo people,
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now the other criticism you could make is, oh, these
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therapists are the blinding doesn't work, and the therapists are
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now biased because now they know who gets MDMA and
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who doesn't, and they're gonna try harder with the people
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that get MDMA and they're not going to try so
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hard with the PLAICCBO people. Well, first off, that's totally
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not true. We have videotapes of all these therapy sessions.
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We've had adherence raiders. That's not true. But the other
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thing is, if you look at the second phase three study,
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unbelievableth forty six point seven percent in the placebo group
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no longer had PTSD. That's better than prolonged exposure cognitive processing.
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There's an incredibly low dropout rate. And so the results
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in our control group that got therapy with inact of placebo,
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where seventy five percent knew they had inactive placebo and
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twenty five percent weren't sure. I thought it was MDMA,
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the results are outstanding. So there's no evidence whatsoever that
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this blinding not working caused therapists to be biased in
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their effort. And there's no good solution. That's the other
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big problem is what's a better approach. So we told
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the FDA, you want blinding, you're going to make our
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job easier, we'll give it to you. And they said,
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no therapy with the inactive pacible. Let's make your job
396
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harder to show a difference between the two groups. So
397
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for this current crop of people at the FDA to backtrack,
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it's really outrageous, I think, and you know none of that.
399
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But it's expensive, it's not fair, it's not good to patience.
400
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And I think that the you know, this is something
401
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that people are not aware of, but the FDA is
402
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actually considering a proposal to stop voting at the advisory
403
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committee level. They want to keep the advisory committee to
404
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get give advice, but the voting makes it seem like
405
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they have more credibility and more power than they really do.
406
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And the lack of knowledge in this group of people
407
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at the advisory committee was astonishing. In fact, the most
408
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outrageous was this one woman, supposedly the patient representative, said, Hey,
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why do we even need new therapies for PTSD? We
410
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have really good evidence based therapies for PTSD and they
411
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work great, and they're so much cheaper than this than
412
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they act faster, I mean, unbelievable. I mean, there's a
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million veterans receiving disability for PTSD from the VA. You know,
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we included people in our studies that had tried therapies,
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had tried medications. This idea from the patient representative that
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we don't need new treatments for PTSD is so out
417
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of touch. But those were the people that were asked
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by FDA to review, and they really were out of
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their depth.
420
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Yeah, that was one of the most shocking things was
421
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the composition of the committee itself. So in light of
422
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where do we go from here, I don't know if
423
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there are ongoing discussions between like Closet and the FDA
424
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on how to go forward. I'm curious whether some kind
425
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of open placebo trial would be one possibility. Up Basically,
426
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people know they're getting a placebo and they know they're
427
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not getting a placebyl and so it makes it process transparent,
428
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and then you're looking at the data as similar to
429
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some of the effects you saw in there that people
430
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who didn't realize they got the placeble, and some of
431
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those people who did realize they got placeble still had
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therapeutic effects in the situation. So I'm not sure whether
433
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that could work in this stuff, but some way around
434
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so it seems like the way they're presenting this blating
435
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issue almost is saying you can't get there from here.
436
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Well, what the FDA. You know, the evidence needs to
437
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be presented to the FDA, the data needs to present
438
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the FDA. So LICOS is engaging in the next couple
439
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months with discussions about FDA. There's been some leakage about
440
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what was in this letter published in Psychedelic Alpha, a
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newsletter for investors in psychedelgics, and one of the things
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that they said was that Licos is saying that, oh,
443
00:23:44.640 --> 00:23:48.759
we don't understand this therapy, so don't use it. Don't
444
00:23:48.880 --> 00:23:51.839
use the therapy that got these incredible results with MDMA,
445
00:23:51.920 --> 00:23:56.079
but use MDMA with the evidence based therapy like prolonged
446
00:23:56.079 --> 00:23:59.599
exposure or something like that. Then they said, not in
447
00:23:59.599 --> 00:24:01.640
the direction you're saying, but they would want like an
448
00:24:01.680 --> 00:24:05.599
active placebo of something. So they're considering lodos MDMA, which
449
00:24:05.640 --> 00:24:08.640
we considered explored for sixteen years in abandon but they
450
00:24:08.640 --> 00:24:11.160
may go back to that, or they may go to
451
00:24:11.400 --> 00:24:15.359
quote psychological support, which is MDMA without therapy at all.
452
00:24:15.839 --> 00:24:17.799
So the concern I have is if they go in
453
00:24:17.839 --> 00:24:21.160
that direction based on kind of pressure from FDA or
454
00:24:21.200 --> 00:24:24.839
suggestions or requirements from FDA. If you get it approved,
455
00:24:25.200 --> 00:24:28.319
what's going to happen with insurance companies. They'll pay for
456
00:24:28.359 --> 00:24:29.960
the drug, but they're not going to pay for more
457
00:24:30.000 --> 00:24:32.759
therapy than was used in the phase three studies. Does
458
00:24:32.839 --> 00:24:35.319
Lecos care about that? I don't know. I think they
459
00:24:35.359 --> 00:24:39.000
care about selling the drug and what's best for patients
460
00:24:39.079 --> 00:24:42.440
is a separate thing. So I'm worried that the design
461
00:24:42.519 --> 00:24:46.359
of the new Phase three study will be to minimize
462
00:24:46.400 --> 00:24:50.680
the role of therapy to use psychological support. I'm fine
463
00:24:50.720 --> 00:24:53.359
if they want to use an active I mean a lotos.
464
00:24:53.480 --> 00:24:56.039
MDMA is a placebo. You know, all the work that's
465
00:24:56.079 --> 00:24:58.559
been done with psilocybin, a lot of it has been
466
00:24:58.680 --> 00:25:01.640
using niasin as an active placebo. Nice and gives you
467
00:25:01.720 --> 00:25:04.480
to a flush and stuff, but it's not psychedelican anyway.
468
00:25:04.519 --> 00:25:06.799
Nobody is fooled by that. You know, if you give
469
00:25:06.799 --> 00:25:10.039
people a tranquilizer, the therapists are not going to be fooled.
470
00:25:10.079 --> 00:25:11.680
Then the people are not going to be thinking, oh,
471
00:25:11.680 --> 00:25:15.119
this is MDMA. And if you give a stimulant like amphetamine,
472
00:25:15.559 --> 00:25:17.880
which doesn't have the heart opening properties of MDMA but
473
00:25:17.960 --> 00:25:20.000
has some in that direction, you know, I think it'll
474
00:25:20.039 --> 00:25:23.599
lack more like lotos. MDMA could be compromising of the therapy.
475
00:25:23.839 --> 00:25:25.839
People could still get better. So I don't know that
476
00:25:25.880 --> 00:25:28.720
there's a better solution, but the FDA is going to say, oh,
477
00:25:28.759 --> 00:25:31.599
do something different, and LIKECOS will say, you know, tell
478
00:25:31.680 --> 00:25:32.119
us what to.
479
00:25:32.039 --> 00:25:35.319
Be Inevitably there will be another pace free trial.
480
00:25:35.519 --> 00:25:38.039
You think, yeah, see, oh for sure, not only were
481
00:25:38.119 --> 00:25:41.240
they well, First off, the FDA approaches essential. We need
482
00:25:41.279 --> 00:25:43.960
to go through the FDA. It's critical they get insureman's coverage,
483
00:25:44.000 --> 00:25:46.160
even if it's just for the drug. And at the
484
00:25:46.200 --> 00:25:49.240
same time, I think lycos will succeed that they've got
485
00:25:49.480 --> 00:25:51.839
I think this delay will be maybe three years. I
486
00:25:51.880 --> 00:25:55.160
don't know how long it'll actually be, but I Thinklecos
487
00:25:55.200 --> 00:25:59.200
will in the end succeed with something. And the other
488
00:25:59.319 --> 00:26:01.720
point is you don't need outstanding results like we had
489
00:26:01.720 --> 00:26:05.319
to succeed. You just need statistical significance. You know, whether
490
00:26:05.359 --> 00:26:09.319
insurance companies will pay for stuff if it's marginally effective
491
00:26:09.480 --> 00:26:12.720
is another question. The other issue about durability, which we
492
00:26:12.799 --> 00:26:16.640
do have very good durability. Not we but LIKECOS or MAPS,
493
00:26:16.680 --> 00:26:21.599
the PTSD patients for really good variability durability, I mean,
494
00:26:21.880 --> 00:26:24.960
and that's key for insurance coverage because it's labor intensive
495
00:26:24.960 --> 00:26:27.960
at the beginning and if it fades over time, they
496
00:26:27.960 --> 00:26:29.799
won't pay for it, but if it's durable they will.
497
00:26:30.319 --> 00:26:33.039
So I do think that Locos will succeed with something
498
00:26:33.160 --> 00:26:36.279
in about three years. And what MAPS is trying to
499
00:26:36.319 --> 00:26:39.960
do is work on creating a nonprofit in Europe to
500
00:26:40.000 --> 00:26:42.759
see if we can raise money from donors. We might
501
00:26:42.839 --> 00:26:45.559
need up to one hundred million or something, but can
502
00:26:45.599 --> 00:26:48.759
we do that and that would permit us to develop
503
00:26:48.880 --> 00:26:54.079
MDMA assistant therapy in Europe with open science, no patents,
504
00:26:54.119 --> 00:26:57.160
and turn it immediately into a generic That's something It's
505
00:26:57.200 --> 00:26:59.319
a long shot, but that's what MAPPS will be working
506
00:26:59.319 --> 00:27:00.519
with others in your to do.
507
00:27:00.920 --> 00:27:04.720
I'm curious as we know, in Australia, the government recently
508
00:27:04.839 --> 00:27:08.599
this year approved both the MDAMA and psilocybin for prescribed
509
00:27:08.640 --> 00:27:13.960
therapeuticcuse and it's currently being used by therapists, psychiatrists, psychotherapists
510
00:27:13.960 --> 00:27:16.720
to go through some kind of initial approval process and
511
00:27:16.720 --> 00:27:19.240
then they're able to use it with their patients. And
512
00:27:19.319 --> 00:27:22.079
I understand it was a bit of a different process there.
513
00:27:22.599 --> 00:27:25.240
The drug actually hasn't been registered what you would call
514
00:27:25.400 --> 00:27:29.400
registered in Australia, which would require an FDA type clinical
515
00:27:29.480 --> 00:27:32.200
trial process, but rather it's been approved by some kind
516
00:27:32.240 --> 00:27:35.119
of governmental process that am I saying was driven as
517
00:27:35.200 --> 00:27:39.480
much by consumer demand and tens of thousands of patient
518
00:27:39.559 --> 00:27:42.039
testimonials as much by that as a science.
519
00:27:42.079 --> 00:27:42.240
Now.
520
00:27:42.240 --> 00:27:45.000
They certainly did reference to clinical trials going on worldwide,
521
00:27:45.039 --> 00:27:47.440
but it seems like it was a different process altogether,
522
00:27:48.079 --> 00:27:50.599
and I'm wondering whether there's anything to learn from that
523
00:27:50.720 --> 00:27:53.079
or are there any other mechanisms in the US outside
524
00:27:53.119 --> 00:27:57.599
of complete legalization or during criminalization that could move the
525
00:27:57.599 --> 00:27:58.440
ball down the field.
526
00:27:59.119 --> 00:28:05.240
Yeah. Well, there's program called expanded access, which is compassionate use. Basically,
527
00:28:05.319 --> 00:28:07.839
LECOS did have an expanded access protocol where you get
528
00:28:07.880 --> 00:28:11.359
MDMA similar in the Phase three design, but there's no
529
00:28:11.480 --> 00:28:14.599
control group and the data is only for safety, not
530
00:28:14.720 --> 00:28:19.680
for efficacy because there's no control group, ANDCOS, for financial
531
00:28:19.680 --> 00:28:21.759
reasons is shut that down. It takes a bit of
532
00:28:21.799 --> 00:28:25.079
time to manage that staff, time and money, so that's
533
00:28:25.119 --> 00:28:27.519
not going to happen. In Australia. It is more like
534
00:28:27.559 --> 00:28:33.279
this compassionate access. You know, Canada they call it special protocol. Yes,
535
00:28:33.359 --> 00:28:37.960
so there's compassionate using Canada and Australia. It's patient by patient.
536
00:28:38.079 --> 00:28:42.079
It is compassionate use. In the US. There the big hope,
537
00:28:42.079 --> 00:28:45.319
and this might take six months or so to resolve,
538
00:28:45.640 --> 00:28:48.640
is what's called right to try. So there's a bunch
539
00:28:48.680 --> 00:28:52.640
of laws in thirty nine states I think that say
540
00:28:52.640 --> 00:28:55.880
that patients have a right to try drugs that are
541
00:28:55.960 --> 00:28:59.480
being developed by pharma if they've tried other medications and
542
00:28:59.519 --> 00:29:02.680
they haven't worked, and there's an experimental drug, then they
543
00:29:02.680 --> 00:29:04.680
should have our right to try, meaning that they can
544
00:29:04.799 --> 00:29:07.880
contact the pharma company and see if they will provide
545
00:29:07.920 --> 00:29:10.640
access to the drug outside of the FDA, not for
546
00:29:10.720 --> 00:29:14.039
research at all, but just as again as a compassionate use. Now,
547
00:29:14.519 --> 00:29:19.720
right to try is prohibited right now from being applied
548
00:29:19.759 --> 00:29:23.960
to controlled substances, meaning scheduled drugs. And there was a
549
00:29:24.039 --> 00:29:27.920
lawsuit about two weeks ago against the DEA by Catherine
550
00:29:27.960 --> 00:29:31.960
Tucker and the others to try to expand right to
551
00:29:32.079 --> 00:29:36.799
try to control substances, and the outcome of that lawsuit
552
00:29:36.880 --> 00:29:39.160
will be known in about six months or so, so
553
00:29:39.240 --> 00:29:45.160
then so promising opportunity if the lawsuit works. Other than that,
554
00:29:45.920 --> 00:29:48.759
you know, there's state level reform. So for example, in November,
555
00:29:48.880 --> 00:29:51.559
just less than two months from now, there's going to
556
00:29:51.559 --> 00:29:56.119
be a ballot initiative in Massachusetts to legalize plant psychedelics,
557
00:29:56.160 --> 00:29:59.559
similar to what passed in Colorado, and expanding on what
558
00:29:59.640 --> 00:30:03.119
passed before in the Oakland psilocybin initiative, which was just
559
00:30:03.160 --> 00:30:06.759
for psilocybin. Now, the problem, from my point of view
560
00:30:06.799 --> 00:30:10.119
is that people have this romantic attachment to plants. But
561
00:30:10.200 --> 00:30:12.920
when you add synthetics like MDMA or psilocybin and you
562
00:30:12.960 --> 00:30:15.279
do the polling, then people don't vote for it, not enough.
563
00:30:15.880 --> 00:30:21.279
So access to MDMA through the state level reforms is
564
00:30:21.400 --> 00:30:25.279
not likely to happen for quite some time because people
565
00:30:25.319 --> 00:30:29.839
again are focused on plants, psychedelics and not synthetics. So
566
00:30:30.039 --> 00:30:33.599
right now, there is no place in the entire world
567
00:30:33.799 --> 00:30:39.799
where people can legally access MDMA outside of a therapeutic protocol. Now,
568
00:30:39.839 --> 00:30:42.319
if you want to go to psilocybin experiences, you can
569
00:30:42.359 --> 00:30:44.720
go to Jamaica, you can go to Costa Rica, you
570
00:30:44.759 --> 00:30:47.240
can go to the Netherlands, you can go to Oregon,
571
00:30:47.279 --> 00:30:49.079
you can go to Colorado. You may be able to
572
00:30:49.160 --> 00:30:52.359
go to the Massachusetts eventually, but there's no place for
573
00:30:52.559 --> 00:30:57.759
MDMA where it's legal without being in a protocol. Unfortunately.
574
00:30:58.920 --> 00:31:01.119
I'm warning about the role of MAPS and kind of
575
00:31:01.160 --> 00:31:04.519
advocacy in Australia. I think there was a you mentioned
576
00:31:04.519 --> 00:31:07.279
this blind period that the traditional blind period during the
577
00:31:07.319 --> 00:31:12.000
FDA process period I'm sorry, quiet period, right, quiet.
578
00:31:11.799 --> 00:31:14.640
Disaster, and not only did lecos quiet, but then they
579
00:31:14.720 --> 00:31:19.480
blocked MAPS and ME from speaking, which was very damaging. Yeah.
580
00:31:19.559 --> 00:31:22.000
So I'm wondering if you have been allowed to have
581
00:31:22.079 --> 00:31:25.319
stronger advocacy that might have because you, as you said,
582
00:31:25.359 --> 00:31:27.599
you think that of Isiac Committee was strongly influenced by
583
00:31:27.640 --> 00:31:30.799
public opinion or different political views, and so public opinion,
584
00:31:31.079 --> 00:31:32.759
and there does seem to be a sea change of
585
00:31:32.799 --> 00:31:36.759
political or public opinion in this country around psychalics and
586
00:31:36.759 --> 00:31:39.480
psychoic medicines, and it'spertally when you hear from the veteran
587
00:31:39.519 --> 00:31:43.680
community and so forth. So I'm wondering if about maps
588
00:31:43.720 --> 00:31:46.920
strategies and with other organizations within the psychaic space in
589
00:31:47.000 --> 00:31:51.559
terms of advocacy, that could marshal enough public opinion and
590
00:31:51.799 --> 00:31:54.400
consumer demand to say, look, you know, there's plenty of
591
00:31:54.440 --> 00:31:56.920
evidence that these things are helping people and this is
592
00:31:56.920 --> 00:32:00.440
something we want. I mean, similarly, you know it's reruly
593
00:32:00.480 --> 00:32:04.480
citizen demand has opened up the whole field of alternative
594
00:32:04.519 --> 00:32:06.880
medicine and even supplements all the rest. At one point,
595
00:32:06.960 --> 00:32:10.319
the FDA and the medical establishment really tried to shut
596
00:32:10.400 --> 00:32:13.559
down the whole world of supplements and all that. At
597
00:32:13.559 --> 00:32:16.759
one point, I think studies showed that citizens were spending
598
00:32:16.799 --> 00:32:20.240
sixty five seventy percent of their medical dollars on alternative medicine,
599
00:32:20.240 --> 00:32:22.799
and I'm sure that freaked out the establishment, but it
600
00:32:22.839 --> 00:32:25.920
really was consumer demand that has really changed that landscape.
601
00:32:25.960 --> 00:32:27.920
So I'm just curious about that whole process.
602
00:32:28.400 --> 00:32:30.000
Yeah, I don't think any of that's going to work
603
00:32:30.039 --> 00:32:33.880
for synthetics like MDMA. Unfortunately, how do you get that?
604
00:32:33.960 --> 00:32:37.200
You know, it gets mediated through state level reforms of
605
00:32:37.359 --> 00:32:41.720
some way, drug decriminalization, you know, or just you know,
606
00:32:42.119 --> 00:32:44.640
there was nineteen s senators and sixty one members of
607
00:32:44.640 --> 00:32:46.720
Congress that sent a letter to the FDA and to
608
00:32:46.839 --> 00:32:51.359
the President Biden saying approve MDMA, But FDA doesn't want
609
00:32:51.400 --> 00:32:54.240
to be swayed by politics, and LYCOS didn't do enough
610
00:32:54.279 --> 00:32:56.720
to respond to the issues that were raised at the
611
00:32:56.759 --> 00:32:57.839
Advisory committee meeting.
612
00:32:59.079 --> 00:33:01.400
Well, it's interesting. MDMA certainly has a history of being
613
00:33:01.480 --> 00:33:04.480
used recreationally, as we all know, but in many ways
614
00:33:04.559 --> 00:33:07.359
it's it could be considered a little more benevolent and
615
00:33:07.440 --> 00:33:10.000
less risky than many of the more powerful psychedelics that
616
00:33:10.279 --> 00:33:11.640
even the plant derived ones.
617
00:33:12.000 --> 00:33:12.920
Yeah, oh very much.
618
00:33:12.920 --> 00:33:13.000
So.
619
00:33:13.160 --> 00:33:16.799
Yeah, people don't have panic reactions as much, you know,
620
00:33:16.880 --> 00:33:19.880
to MDMA as they do for psilocybin. There are people
621
00:33:19.880 --> 00:33:22.559
that have committed murders or committed suicide under the influence
622
00:33:22.559 --> 00:33:24.839
of psilocybin. It's really rare, but that kind of thing
623
00:33:24.839 --> 00:33:28.000
you don't see under MBMA. It's more gentle, filled with
624
00:33:28.000 --> 00:33:32.880
self compassion. So I think that the concerns there are less.
625
00:33:33.160 --> 00:33:35.920
I think it should be legalized and the consequences will
626
00:33:35.920 --> 00:33:39.599
be mostly beneficial with some negative outcomes, but I think
627
00:33:39.640 --> 00:33:41.920
the negative outcomes will be way less than the negative
628
00:33:41.960 --> 00:33:44.880
outcomes from the drug war. I mean, people have died
629
00:33:44.880 --> 00:33:49.200
from ecstasy contaminated with fentanyl. That's correctly related to the
630
00:33:49.279 --> 00:33:52.839
drug war. That's not problems with ecstasy. That's problems or MBMA.
631
00:33:52.960 --> 00:33:55.440
That's problems with underground market its.
632
00:33:55.880 --> 00:33:59.279
Yeah, that's a whole other conversation. The collateral damage of
633
00:33:59.319 --> 00:34:03.559
criminalization in the drug war seems so nonsensical. You mentioned
634
00:34:03.559 --> 00:34:07.319
before the possible what you're doing in your possible average
635
00:34:07.359 --> 00:34:09.639
you could be making in Europe, and I'm wondering curious
636
00:34:09.639 --> 00:34:12.199
about kind of maps. I know you do think globally
637
00:34:12.320 --> 00:34:14.719
in terms of world this is and you know, even
638
00:34:14.719 --> 00:34:19.519
for humanitarian reasons that how opening up both the therapeutic
639
00:34:19.679 --> 00:34:23.519
use of psychedelics and maybe the more well educated sort
640
00:34:23.519 --> 00:34:27.639
of personal growth use and safe and well educated personal
641
00:34:27.639 --> 00:34:31.360
growth while shifting our views around this could really address
642
00:34:31.480 --> 00:34:35.440
some of the really pressing humanitarian issues we have globally
643
00:34:35.679 --> 00:34:38.000
from the effects of all kinds of trauma and as
644
00:34:38.000 --> 00:34:40.079
well as the mental health crisis and all kinds of
645
00:34:40.159 --> 00:34:41.840
things that are going on not just in the US
646
00:34:41.880 --> 00:34:44.719
but globally. And I'm curious about maps involvement with that
647
00:34:44.760 --> 00:34:47.519
and some of your ideas around that. What is transformation
648
00:34:47.760 --> 00:34:52.239
isn't just about thinking differently but feeling differently. Science shows
649
00:34:52.280 --> 00:34:54.920
us that true change happens when we align not just
650
00:34:55.000 --> 00:34:58.679
our minds, but also the neural networks in our hearts
651
00:34:58.719 --> 00:35:02.039
and guts. This heart mind connection is the key to
652
00:35:02.119 --> 00:35:06.519
deeper healing, resilience, and expanded awareness. That's why I created
653
00:35:06.559 --> 00:35:10.159
the Heart Mind All access, membership and community, a space
654
00:35:10.239 --> 00:35:14.480
designed to help you rewire your nervous system, cultivate heart intelligence,
655
00:35:14.760 --> 00:35:18.320
and live with greater clarity and purpose. With over one
656
00:35:18.400 --> 00:35:23.880
thousand hours of transformational teachings specifically curated to meet your needs,
657
00:35:24.320 --> 00:35:29.599
You'll learn from world renowned meditation teachers, neuroscientists, and experts
658
00:35:29.599 --> 00:35:34.039
in neuroplasticity, all sharing powerful tools to help you shift
659
00:35:34.039 --> 00:35:38.840
your mindset and heartset, regulate your emotions, and unlock your
660
00:35:38.880 --> 00:35:43.639
full potential. You'll also gain unlimited access to every summit
661
00:35:43.679 --> 00:35:47.000
and course we've ever produced, a Treasure Trouble Wisdom worth
662
00:35:47.039 --> 00:35:50.760
over ten thousand dollars in growing, plus live gatherings, and
663
00:35:50.800 --> 00:35:54.719
an inspiring global community to support your journey. If you're
664
00:35:54.760 --> 00:35:57.480
ready to step into a more heart centered, connected and
665
00:35:57.519 --> 00:36:00.559
conscious life, I invite you to join us. Clip the
666
00:36:00.639 --> 00:36:03.239
link to learn more and start your journey today.
667
00:36:04.320 --> 00:36:06.719
Wow. Thank you for asking that, because that's really a
668
00:36:06.760 --> 00:36:09.280
lot of the areas that I'm working on right now,
669
00:36:09.400 --> 00:36:12.400
which is I'll just say from an advocacy point of view, though,
670
00:36:12.440 --> 00:36:15.039
just to mention that in June sixteenth to twentieth of
671
00:36:15.280 --> 00:36:17.920
twenty twenty five, we're going to have the world's largest
672
00:36:17.960 --> 00:36:22.119
conference on psychedelacs ever in Denver. We had Psychedelic Science
673
00:36:22.159 --> 00:36:26.440
twenty twenty three that was in Denver twelve four hundred people,
674
00:36:26.880 --> 00:36:30.360
so we anticipate even more people for this upcoming conference
675
00:36:30.400 --> 00:36:33.199
in June in Denver to bring the community together, to
676
00:36:33.480 --> 00:36:36.320
share ideas and things like that, and to bring people
677
00:36:36.360 --> 00:36:38.519
from all over the world. And we're talking about potentially
678
00:36:38.559 --> 00:36:41.480
a track from the global psychedelic societies, because there are
679
00:36:41.480 --> 00:36:44.800
psychedelic societies all over the world. Now, as far as
680
00:36:44.800 --> 00:36:48.760
our humanitarian projects, I saw something some information not too
681
00:36:48.760 --> 00:36:51.360
long ago that talked about the lag between drugs that
682
00:36:51.400 --> 00:36:54.800
are approved in it by FDA or by EMA and
683
00:36:54.880 --> 00:36:57.840
the time these drugs reached the Third World, and often
684
00:36:57.880 --> 00:37:01.840
it's well over a decade or more, and so there
685
00:37:01.880 --> 00:37:07.039
is massive amounts of trauma, especially in poorer countries. You know,
686
00:37:07.039 --> 00:37:09.119
there's an estimate that there could be a billion climate
687
00:37:09.159 --> 00:37:12.920
refugees by twenty fifty and these will all be traumatized
688
00:37:12.920 --> 00:37:15.719
people who will be destabilizing societies. They'll be trauma all
689
00:37:15.760 --> 00:37:18.159
over the place. So I think it's really important that
690
00:37:18.159 --> 00:37:19.880
we think globally. I think one of the things that
691
00:37:19.960 --> 00:37:22.559
Lecos ignored at its peril was this idea that it's
692
00:37:22.599 --> 00:37:25.519
only about the data, which means that they ignored the culture,
693
00:37:25.519 --> 00:37:27.519
and it's only about the US, which means they shut
694
00:37:27.519 --> 00:37:30.840
down Europe. So we have a series of small pilot
695
00:37:30.960 --> 00:37:34.480
studies that we're trying to start, and MAPS is also
696
00:37:34.639 --> 00:37:39.360
doing international trainings, So we are recently had trainings in
697
00:37:39.400 --> 00:37:43.599
Bosni and Sarajevo. We've had trainings in Iceland. So the
698
00:37:43.639 --> 00:37:48.920
first example of a program humanitarian projects is in Somaliland
699
00:37:49.239 --> 00:37:53.639
in Africa, and there's Dale Armstrong's a US psychiatrist that
700
00:37:53.880 --> 00:37:57.679
sort of adopted this area of Somaliland, building a medical
701
00:37:57.679 --> 00:38:01.159
clinic things like that. And so we trained a bunch
702
00:38:01.199 --> 00:38:03.840
of Smiley Land therapists and then they got permission from
703
00:38:03.840 --> 00:38:07.320
their government to import two point one grams of MDMA
704
00:38:07.480 --> 00:38:10.719
for a protocol to give MDMA to therapist as part of
705
00:38:10.760 --> 00:38:13.559
their training, because these are people that have no psychedelic history,
706
00:38:13.960 --> 00:38:17.039
and it was just amazing how much mdmay helped them
707
00:38:17.159 --> 00:38:21.639
personally and how much this experience prepared them for working
708
00:38:21.639 --> 00:38:24.760
with PTSD patients. And now that's in the process of
709
00:38:24.840 --> 00:38:28.639
designing the next study with some body land people with PTSD.
710
00:38:29.079 --> 00:38:31.760
In Bosnia, we're working with the team there that want
711
00:38:31.880 --> 00:38:34.159
to we've trained them. They wanted to do a study
712
00:38:34.199 --> 00:38:38.079
with survivors of the shred Brenica massacre about thirty years
713
00:38:38.079 --> 00:38:41.000
ago where an eighty six hundred or so men and
714
00:38:41.119 --> 00:38:43.639
boys Muslim men and boys were all murdered. So this
715
00:38:43.679 --> 00:38:47.400
would be for women survivors of that. There's a project
716
00:38:47.440 --> 00:38:50.599
in Denmark that we're working to start to help the
717
00:38:50.639 --> 00:38:54.079
people start there. That would be with Syrian refugees in
718
00:38:54.199 --> 00:38:58.920
Denmark second generation, the ones that speak English, less religious
719
00:38:58.960 --> 00:39:01.360
than their parents and are believing that they're going to
720
00:39:01.360 --> 00:39:04.599
stay in Denmark. We're talking about a project that we've
721
00:39:04.599 --> 00:39:07.880
been approached in Rwanda. We haven't had any resources for
722
00:39:07.960 --> 00:39:11.760
that yet. We're talking about training in Ukraine and to
723
00:39:11.840 --> 00:39:15.280
try to bring MDMA to Ukraine and their terrible time
724
00:39:15.360 --> 00:39:18.920
of massive culture wide trauma. And so if we can
725
00:39:18.960 --> 00:39:22.440
do these and maybe one or two other humanitarian projects,
726
00:39:22.920 --> 00:39:25.920
the goal is to do them, to train the trainers,
727
00:39:26.079 --> 00:39:29.079
meaning to help the therapists they learn how to train
728
00:39:29.079 --> 00:39:31.039
another therapist, and then to go for like one hundred
729
00:39:31.039 --> 00:39:32.719
million dollar grant a year and a half or two
730
00:39:32.760 --> 00:39:36.400
years or so from now to really globalize access in
731
00:39:36.480 --> 00:39:38.880
humanitary ways, because these are things the pharma company is
732
00:39:38.920 --> 00:39:41.039
not going to do, and yet the need is great.
733
00:39:41.119 --> 00:39:44.159
And people may have heard about the study with octopuses
734
00:39:44.320 --> 00:39:47.760
where Gould, Dolan and hero scientists at Hopkins and now
735
00:39:47.800 --> 00:39:51.880
at Berkeley, but she gave MDMA to octopuses maps provided
736
00:39:51.920 --> 00:39:56.440
the MBMA, and octopuses became pro social. They're solitary creatures,
737
00:39:56.920 --> 00:39:58.920
but under the influence of MDMA they wanted to hang
738
00:39:58.920 --> 00:40:03.920
out with other octopuses. So it gets pro social, evolutionary, conserved,
739
00:40:04.000 --> 00:40:07.239
and pre verbal. So I think that what we're going
740
00:40:07.320 --> 00:40:09.519
to find is that MDMA is going to work cross
741
00:40:09.519 --> 00:40:12.239
culturally in all these different contexts. We'll have to figure
742
00:40:12.239 --> 00:40:16.119
out what's the therapeutic context things like that. But that
743
00:40:16.119 --> 00:40:17.800
I think is one of the more exciting things that
744
00:40:17.840 --> 00:40:19.480
MAPS is going to be working on, is to really
745
00:40:19.480 --> 00:40:24.400
to globalize access to highly traumatized populations that maybe don't
746
00:40:24.400 --> 00:40:27.559
have a lot of resources. There's something else that MAPS
747
00:40:27.679 --> 00:40:29.800
is going to do with this. We're trying to start
748
00:40:29.840 --> 00:40:34.199
this nonprofit in Europe that would end up trying to say,
749
00:40:34.280 --> 00:40:38.159
let's follow the Dutch position naturalistic studies and then negotiate
750
00:40:38.199 --> 00:40:40.760
it with them A and MHR in England if they
751
00:40:40.760 --> 00:40:45.400
would accept people treated in naturalistic studies as equivalent to
752
00:40:45.559 --> 00:40:48.800
a Phase three study. Then there's something else that's really
753
00:40:48.840 --> 00:40:52.639
interesting for me, which is MDMA for couples therapy. So
754
00:40:52.880 --> 00:40:55.840
couple's therapy is not a disorder. People think, well, the
755
00:40:55.920 --> 00:40:58.400
FDA has never approved a drug and psychiatry for something
756
00:40:58.440 --> 00:41:01.000
that's not a clinical disorder, but there's nothing in the
757
00:41:01.079 --> 00:41:03.880
law that prevents them from doing that. And the advantage
758
00:41:03.880 --> 00:41:07.039
of FDA approval is that then you have insurance coverage potentially.
759
00:41:07.119 --> 00:41:09.840
So we're going to start a study in California with
760
00:41:10.000 --> 00:41:13.559
MDMA for couple's therapy. That's going to be really exciting.
761
00:41:13.639 --> 00:41:16.519
Then the other thing is MAPS is doing twelve point
762
00:41:16.599 --> 00:41:19.119
nine We've got a twelve point nine million dollar grant
763
00:41:19.159 --> 00:41:22.159
from the state of Michigan for a cannabis for PTSD
764
00:41:22.719 --> 00:41:25.920
in three hundred and twenty veterans, and so FDA is
765
00:41:25.960 --> 00:41:28.840
blocking us from doing that study, not permitting us to
766
00:41:28.840 --> 00:41:32.440
study smoked marijuana or vaporized marijuana for reasons that are
767
00:41:32.440 --> 00:41:35.880
not very good. So we've just launched a formal dispute
768
00:41:35.880 --> 00:41:39.639
with lawyer scientists against the FDA two weeks ago trying
769
00:41:39.679 --> 00:41:43.360
to unblock this study with you know, the way people
770
00:41:43.519 --> 00:41:46.679
with PTSD. Veterans with PTSD use cannabis. Some of them
771
00:41:46.679 --> 00:41:49.760
will do it edibles, but most will smoke or vaporize. So,
772
00:41:50.159 --> 00:41:52.800
you know, I find a very amusing in the meeting
773
00:41:52.880 --> 00:41:54.760
we had with the FDA after they blocked it to
774
00:41:54.800 --> 00:41:57.360
try to see if we could come to an agreement
775
00:41:57.400 --> 00:42:00.119
before we do this formal dispute, which will cost three
776
00:42:00.199 --> 00:42:02.480
hundred thousand or son legal fees. We were talking about
777
00:42:02.480 --> 00:42:05.039
this project, and the woman from FDA said, I hate
778
00:42:05.079 --> 00:42:09.559
the word medical marijuana because it's not medical until we
779
00:42:09.719 --> 00:42:12.440
say it. Is said that at a meeting where she's
780
00:42:12.440 --> 00:42:15.960
blocking us from doing research with marijuana. Mind boggling.
781
00:42:16.480 --> 00:42:19.840
So, in terms of your global efforts with MDMA, so
782
00:42:20.320 --> 00:42:23.400
is does Lycos control the patent for MDMA.
783
00:42:24.000 --> 00:42:26.719
No? No, So First off, MDMA was invented by merk
784
00:42:26.800 --> 00:42:29.920
in nineteen twelve, so the molecules in the public domain.
785
00:42:30.480 --> 00:42:33.679
I hired patent attorneys in the late nineteen eighties early
786
00:42:33.800 --> 00:42:36.920
nineteen nineties to help MAPS develop an anti patent for
787
00:42:37.039 --> 00:42:40.360
the uses, which is we publish stories about all different
788
00:42:40.440 --> 00:42:42.440
uses of MDMA, and the website we can say they
789
00:42:42.440 --> 00:42:46.920
invented it. MDMA for postpartum depression, MDMA for fibermyalgia, all
790
00:42:46.920 --> 00:42:49.800
these different things people have said they've received helix. What
791
00:42:49.920 --> 00:42:52.920
Licos is trying to do is to patent the particle
792
00:42:53.039 --> 00:42:58.360
size of the MDMA molecule to optimize it going through
793
00:42:58.679 --> 00:43:03.559
high throughput encapsulation machine. That's the patent that they're going
794
00:43:03.599 --> 00:43:05.559
to try to get. And this is in the public
795
00:43:05.559 --> 00:43:10.280
domain already for them to block generics. Whether they'll get
796
00:43:10.360 --> 00:43:14.079
that or not, I don't know if they do get that,
797
00:43:14.159 --> 00:43:16.719
I think it's easy to not infringe on that patent
798
00:43:16.800 --> 00:43:19.679
and do things in other ways. There's a challenge in
799
00:43:19.719 --> 00:43:22.880
that when you're a pharma company, you can in your
800
00:43:23.199 --> 00:43:25.840
either data exclusivity or one patent is expiring, you've got
801
00:43:25.880 --> 00:43:28.719
another one. You want to delay generics as long as
802
00:43:28.719 --> 00:43:31.320
you can, so you sue them for infringing, and the
803
00:43:31.360 --> 00:43:33.719
FDA is once that those kind of suits happen, the
804
00:43:33.760 --> 00:43:36.000
FDA is automatically blocked for two and a half years
805
00:43:36.440 --> 00:43:39.480
permissioning a license to the generic to give time for
806
00:43:39.519 --> 00:43:42.599
the court lawsuit to work it out. Now, in Australia,
807
00:43:42.679 --> 00:43:45.760
if you are a generic company and your suit for
808
00:43:45.840 --> 00:43:47.599
infringing on the patent and it turns out you don't
809
00:43:47.639 --> 00:43:50.760
infringe on the patent, the company has to pay the
810
00:43:50.800 --> 00:43:53.039
innovator company has to pay your legal fees, but they
811
00:43:53.039 --> 00:43:55.519
have to pay fines because of all the money that
812
00:43:55.559 --> 00:43:58.599
they made when it should have been a generic. There's
813
00:43:58.639 --> 00:44:02.440
no such law like that in the So the other
814
00:44:02.480 --> 00:44:04.960
part of this is that when you are a generic
815
00:44:05.039 --> 00:44:08.599
manufacturer and you have not been sued in forty five days,
816
00:44:09.119 --> 00:44:11.360
you can go to the courts for summary judgment that
817
00:44:11.440 --> 00:44:13.440
you'll never be sued, but the condition is you have
818
00:44:13.519 --> 00:44:16.239
to make your entire package of the FDA available to
819
00:44:16.280 --> 00:44:19.679
the competitor, the innovator company, to look at and see
820
00:44:19.679 --> 00:44:22.719
if there's any evidence of infringement. I said to the
821
00:44:22.760 --> 00:44:25.239
company that when I was still on the lycosport, that
822
00:44:25.320 --> 00:44:27.159
we should make a good faith effort to see if
823
00:44:27.159 --> 00:44:30.360
they infringe before we sue during these forty five days.
824
00:44:30.639 --> 00:44:34.519
That was not well received unfortunately. So I do think
825
00:44:34.559 --> 00:44:39.719
that the effort by Licos to patent particle size is
826
00:44:39.880 --> 00:44:41.360
something that'll probably take a year and a half or
827
00:44:41.400 --> 00:44:44.320
so to figure out if they get it. Now, there's
828
00:44:44.360 --> 00:44:47.360
a company called Tiaran Biosciences. What Licos has done is
829
00:44:47.559 --> 00:44:51.079
MDMA hydrochloride, which is DA with a certain kind of salt.
830
00:44:51.360 --> 00:44:55.159
They're trying to claim that, even though assaults can act differently,
831
00:44:55.760 --> 00:44:59.960
that the patent that they've asked for on particle side,
832
00:45:00.199 --> 00:45:03.960
which they generated from working with MDMA hydrochloride, should apply
833
00:45:04.039 --> 00:45:07.199
to all the different salts that MDMA can be combined
834
00:45:07.239 --> 00:45:10.679
with or manufactured with. So there's another company in Terran
835
00:45:10.719 --> 00:45:14.639
Biosciences that is patent MDMA with a different salt, and
836
00:45:14.679 --> 00:45:18.239
it is claiming that it will not be covered by
837
00:45:18.360 --> 00:45:21.679
the lycos pat and then they want to, you know,
838
00:45:22.079 --> 00:45:25.000
as soon as possible, make MDMA into a generic So
839
00:45:25.440 --> 00:45:26.840
you know, I don't know how that's all going to
840
00:45:26.880 --> 00:45:29.760
play out, but I do think that the problem is
841
00:45:29.800 --> 00:45:32.800
with philanthropal at the part the situation is with philanthropists.
842
00:45:32.800 --> 00:45:36.079
They're not looking to monopoly situations. They're looking to heal
843
00:45:36.159 --> 00:45:39.840
people right doing masters, They're looking not so much to
844
00:45:39.880 --> 00:45:41.719
heal people, but to use healing people as a way
845
00:45:41.719 --> 00:45:46.760
to make money. And so you know, how will patents
846
00:45:46.800 --> 00:45:50.880
be enforced, how will they be applied for? But my
847
00:45:51.440 --> 00:45:54.360
I'm not a patent attorney, but my sense is that
848
00:45:54.480 --> 00:45:58.400
there's a good chance that the salt that Terran Bioscience
849
00:45:58.400 --> 00:46:03.679
has combined with MDMA would not infringe thecos all the
850
00:46:03.719 --> 00:46:05.840
likecos claims that it's worked will apply to all the
851
00:46:05.880 --> 00:46:08.360
different salts to so a lot to see what the
852
00:46:08.440 --> 00:46:09.000
FDA does.
853
00:46:09.199 --> 00:46:12.400
I mean, well, the theologist plays out, and I mean
854
00:46:12.480 --> 00:46:14.960
as fascinating as that is. Systemically, I mean there's so
855
00:46:14.960 --> 00:46:18.559
many there's the economics and a business interests, there's the politics,
856
00:46:18.599 --> 00:46:21.840
there's a cultural forces, and then there's the actual science
857
00:46:21.880 --> 00:46:24.280
and then most importantly, there's the need of people who
858
00:46:24.280 --> 00:46:27.480
are suffering, and that should I think most of we
859
00:46:27.480 --> 00:46:28.440
should predominate.
860
00:46:28.960 --> 00:46:31.320
What I would say is the need is really critical,
861
00:46:31.760 --> 00:46:35.519
but it's the culture that really is where the cultural
862
00:46:35.599 --> 00:46:38.440
change has to take place. That's where I think Lecos
863
00:46:38.440 --> 00:46:41.280
felled down. Is to think it's a rational process. We've
864
00:46:41.320 --> 00:46:43.960
evolved to the point where FDA will just look at
865
00:46:43.960 --> 00:46:47.320
the data. Culture doesn't matter. And that quiet period when
866
00:46:47.320 --> 00:46:50.119
the culture was started to erupt with negativity, and then
867
00:46:50.360 --> 00:46:53.559
the decision was made, oh, let's not apply, not replought,
868
00:46:53.719 --> 00:46:55.760
And that's why I think built and built and built,
869
00:46:55.760 --> 00:46:58.360
and that's what led to the negative outcomes.
870
00:46:58.880 --> 00:47:01.639
Well, speaking of the culture, sure somewhat, I guess parallel
871
00:47:01.880 --> 00:47:04.960
trajectories and forces and trends. On the one hand, the
872
00:47:05.679 --> 00:47:09.960
efforts to reschedule schedule one psychic medicines for therapeutic use
873
00:47:10.119 --> 00:47:13.559
and the medicalization of those to create distribution systems and
874
00:47:13.639 --> 00:47:16.320
third party payment with insurers.
875
00:47:15.800 --> 00:47:18.599
In that whole world, and then.
876
00:47:18.480 --> 00:47:23.760
This psychaic renaissance that's going on, and the widespread semi
877
00:47:23.800 --> 00:47:27.559
above ground, semi blow ground use by people for personal growth.
878
00:47:27.679 --> 00:47:30.079
I mean some recreational obviously, and some of it may
879
00:47:30.079 --> 00:47:33.079
not be but a lot of people really looking spiritual growth,
880
00:47:33.079 --> 00:47:35.719
personal growth and going all around the world to do
881
00:47:35.760 --> 00:47:38.000
it as well. And then here in the US, some
882
00:47:38.639 --> 00:47:44.119
as you mentioned in Oakland, California and Colorado, possibly in Massachusetts,
883
00:47:44.400 --> 00:47:47.559
in Oregon, there's there's these efforts of decriminalization and some
884
00:47:47.599 --> 00:47:51.400
active decriminalization and policy making happening. And so I wonder
885
00:47:52.039 --> 00:47:55.920
how you see these two parallel worlds operating. Is there
886
00:47:56.000 --> 00:47:58.719
can there be a mutual benefit that will move things
887
00:47:58.760 --> 00:48:02.159
down the field, or they cross purposes sometimes or.
888
00:48:02.559 --> 00:48:05.239
Well I think that Lycos feels that they're at cross purposes,
889
00:48:05.280 --> 00:48:08.599
but I think they're mutually supportive. So, as I said,
890
00:48:08.639 --> 00:48:11.320
it's really about the culture. I mean, psychedelic research was
891
00:48:11.360 --> 00:48:15.159
blocked for more than two decades. That's not because of
892
00:48:15.199 --> 00:48:18.480
the science from the nineteen seventy controls obs SEC That's
893
00:48:18.480 --> 00:48:21.920
because of politics. That's because of culture. That's because of
894
00:48:21.960 --> 00:48:25.519
the fear engendered in people about psychedelics. So I think
895
00:48:25.519 --> 00:48:29.920
that the culture is the critical factor, and that that's
896
00:48:29.960 --> 00:48:33.679
something that we constantly be needing to be educating people
897
00:48:33.760 --> 00:48:37.639
about things like that, and that this idea of how
898
00:48:37.679 --> 00:48:39.880
do we do this public education? The most important thing
899
00:48:39.920 --> 00:48:43.480
is people telling their stories about having their own healing experiences.
900
00:48:43.480 --> 00:48:45.599
So what we really need is sort of a psychedelic
901
00:48:45.639 --> 00:48:48.079
coming out of all sorts of people that have benefited
902
00:48:48.119 --> 00:48:51.719
from psychedelics, you know, speaking in public about it, so
903
00:48:51.840 --> 00:48:55.639
to help people understand more from people that they trust
904
00:48:55.679 --> 00:49:00.360
about benefits, to balance off all the negativity so much
905
00:49:00.599 --> 00:49:04.559
hopeful over time, what will happen is more and more
906
00:49:04.599 --> 00:49:07.719
research will come out, more and more positive research will
907
00:49:07.719 --> 00:49:11.079
come out, and they'll be this sort of return to
908
00:49:11.320 --> 00:49:14.320
hope over fear in the public. And that's what we
909
00:49:14.400 --> 00:49:15.360
really need to be counting on.
910
00:49:16.400 --> 00:49:19.679
I'm curious you mentioned education, So it seemed to me that,
911
00:49:19.920 --> 00:49:22.920
you know, if we're going to get this positive cultural
912
00:49:22.960 --> 00:49:28.400
shift and attitudes or psychedelic medicines and eventually decriminalization or
913
00:49:28.440 --> 00:49:32.440
even legalization in certain areas and more availabily not only
914
00:49:32.920 --> 00:49:36.480
medically prescribed therapy, but for people to explore on their own.
915
00:49:36.679 --> 00:49:38.599
And you know, there's a feeling among many people that
916
00:49:38.800 --> 00:49:42.719
natural plants, anybody should have access to those that along
917
00:49:42.760 --> 00:49:45.199
with ours. All the reasons why we maybe think that's
918
00:49:45.199 --> 00:49:47.559
the way it should be, if we want it that way,
919
00:49:47.599 --> 00:49:51.079
it seems like it's incumbent upon the movement to really
920
00:49:51.119 --> 00:49:52.920
do a lot of education so that we have a
921
00:49:53.000 --> 00:49:57.000
very well educated public. Because these medicines can be powerful,
922
00:49:57.199 --> 00:50:00.920
they can be destabilizing some cases. Overall, compared to a
923
00:50:01.000 --> 00:50:04.079
lot of things, they're pretty benevolent, even compared with alcohol
924
00:50:04.079 --> 00:50:06.800
in many cases. But is still there the idea of
925
00:50:06.840 --> 00:50:10.400
creating an educated consumer, so you avoid a lot, you know,
926
00:50:10.480 --> 00:50:12.920
so you really focused on harm reduction through education. I
927
00:50:12.960 --> 00:50:14.960
guess maybe the point I'm making here.
928
00:50:15.320 --> 00:50:18.280
Yeah, So normally the way that this sort of public
929
00:50:18.400 --> 00:50:22.039
education gets done is with advertising dollars. You know, there's
930
00:50:22.079 --> 00:50:24.679
no product, so that doesn't happen. The way that we've
931
00:50:24.719 --> 00:50:27.119
done it in the past is through doing science because
932
00:50:27.159 --> 00:50:31.599
in our culture, science gets widely reported and that's earned
933
00:50:31.719 --> 00:50:34.800
media that you don't have to pay for. So concentrating
934
00:50:34.840 --> 00:50:37.440
resources on doing the science and then getting the media
935
00:50:37.519 --> 00:50:40.639
to report about it is what's been essential. But there
936
00:50:40.679 --> 00:50:43.880
are still so many people that have not heard these stories,
937
00:50:43.880 --> 00:50:47.239
that don't This is just another This is a while ago,
938
00:50:47.280 --> 00:50:49.239
but the very first date I ever had it with
939
00:50:49.280 --> 00:50:52.119
my wife. Now we've been married thirty one years, but
940
00:50:52.440 --> 00:50:55.480
this was now in nineteen eighty nine. She was a
941
00:50:55.519 --> 00:50:58.239
student at Harvard's Kennedy School Government and we have this
942
00:50:58.360 --> 00:51:00.639
lunch together and at the end, she said, you know,
943
00:51:00.679 --> 00:51:02.079
I just want to tell you I'd never want to
944
00:51:02.079 --> 00:51:04.800
have a relationship, for real relationship with anybody like you.
945
00:51:05.280 --> 00:51:08.000
And I'm like, why is that, you know? And she said, well,
946
00:51:08.000 --> 00:51:10.880
you've done so much LSD your chromosomes are all screwed up.
947
00:51:11.360 --> 00:51:13.639
I'm like, it was kind of funny. I said, it
948
00:51:13.639 --> 00:51:16.159
may be premature, but let me defend my spurn here.
949
00:51:16.360 --> 00:51:18.519
The point I'm trying to make is that she, an
950
00:51:18.559 --> 00:51:24.199
intelligent woman, believed the propaganda right about LSD causing chromosome damage,
951
00:51:24.199 --> 00:51:26.760
which it does not do in any way that affects
952
00:51:26.800 --> 00:51:30.840
a childbirth. So how do we really do this public education?
953
00:51:30.920 --> 00:51:33.000
That's a big part of the Psychedelic Science twenty twenty
954
00:51:33.000 --> 00:51:35.920
five conference we're going to have in June. But well,
955
00:51:36.079 --> 00:51:38.039
and that's why I'm talking to you. I think podcasts
956
00:51:38.039 --> 00:51:41.000
are really helpful, but we need the documentaries on therapists.
957
00:51:41.000 --> 00:51:43.840
There's multiple documentaries that we're trying to help. There's a
958
00:51:44.000 --> 00:51:46.559
feature film that's being made about the book Acid Test
959
00:51:46.719 --> 00:51:49.920
LSD Ecstasy in the Party Heal about our movie that
960
00:51:50.000 --> 00:51:52.320
was going to be with participant media. But then participant
961
00:51:52.360 --> 00:51:53.960
media shut down. So I don't know if they're going
962
00:51:54.000 --> 00:51:57.199
to find the funding or not. But I think I
963
00:51:57.239 --> 00:51:59.599
took a class at hard School of Public Health by
964
00:51:59.599 --> 00:52:03.880
the guy that it introduced helped introduce designated drivers into
965
00:52:03.920 --> 00:52:07.840
the American culture, and he did that through TV shows
966
00:52:07.880 --> 00:52:12.599
and movies having somebody be the designated driver. So that's
967
00:52:12.599 --> 00:52:14.440
what we're trying to do. In terms of your public
968
00:52:14.559 --> 00:52:18.280
education question. The more we can get stories in media,
969
00:52:18.719 --> 00:52:22.960
even fictional stories, the more people will be educated. I mean,
970
00:52:23.480 --> 00:52:26.039
you know, there's just such an enormous reservoir of fear
971
00:52:26.039 --> 00:52:28.480
and misinformation that people have, So we have to do
972
00:52:28.559 --> 00:52:31.320
whatever we can for public education. And I think it's
973
00:52:31.360 --> 00:52:33.920
really important that you're putting your finger at that, and
974
00:52:33.960 --> 00:52:36.119
that is something that we really need to figure out
975
00:52:36.159 --> 00:52:39.800
how to do. But without you know, now, you know,
976
00:52:40.039 --> 00:52:42.960
chos will do some science, but they're going to shy
977
00:52:42.960 --> 00:52:45.920
away I think from public education. I think it's really
978
00:52:45.960 --> 00:52:47.800
through the science that we've been able to make the
979
00:52:47.840 --> 00:52:50.960
progress that we have. And now I think some documentaries
980
00:52:50.960 --> 00:52:54.760
of patients telling their stories will be really effective. Well, yeah,
981
00:52:54.960 --> 00:52:58.119
that's the key. We've got a population that well, you
982
00:52:58.199 --> 00:53:01.679
hear one story of one boundary violation by a therapist
983
00:53:02.360 --> 00:53:05.760
and that becomes the dominant story.
984
00:53:05.880 --> 00:53:09.079
I've been above in criminal justice reform in prison work
985
00:53:09.159 --> 00:53:12.519
for a long time, and they talk about incident driven politics.
986
00:53:13.239 --> 00:53:15.880
You know, you have, for example, community corrections, which has
987
00:53:15.920 --> 00:53:19.920
proven to work. It's vastly inexpensive compared to incarcerating people.
988
00:53:20.320 --> 00:53:23.039
But you have one person on proll that messes up,
989
00:53:23.079 --> 00:53:25.360
and suddenly you're going to change the whole policy and
990
00:53:25.400 --> 00:53:28.400
spend a gazillion dollars locking everybody up when actually has
991
00:53:28.440 --> 00:53:31.159
been proven the statistically, it makes total sense to keep
992
00:53:31.159 --> 00:53:33.360
a lot of people in the community. So that incident
993
00:53:33.480 --> 00:53:36.280
driven politics kind of affect a lot of things. I'm
994
00:53:36.320 --> 00:53:37.760
curious about this idea.
995
00:53:37.800 --> 00:53:38.039
You know.
996
00:53:38.239 --> 00:53:41.159
So we're training therapists, and I think a really important
997
00:53:41.239 --> 00:53:43.760
terms of the therapeutic use of psychotic medicines that the
998
00:53:43.840 --> 00:53:46.440
training be really good, the standards be really good. I
999
00:53:46.480 --> 00:53:49.320
know MAPS had a training program for the therapists involved
1000
00:53:49.320 --> 00:53:53.159
in your clinical TRIALCYIS and Europa both have master's level
1001
00:53:53.480 --> 00:53:57.239
professional programs. I think I entered while at Unie Arizona's
1002
00:53:57.239 --> 00:53:59.800
developing one for positions and so forth, So you know,
1003
00:54:00.000 --> 00:54:02.960
developing excellent training, and there's probably some training being developed
1004
00:54:02.960 --> 00:54:06.679
for non clinical guides as well. I'm curious about in
1005
00:54:06.760 --> 00:54:09.679
states where there's an effort at decriminalization even around the
1006
00:54:09.679 --> 00:54:13.880
planet medicines, the idea of almost you know, requiring US
1007
00:54:13.920 --> 00:54:18.159
citizens license of sort, citizens use license. I mean, even
1008
00:54:18.199 --> 00:54:20.440
with the you know, the way marijuana has been, you know,
1009
00:54:20.519 --> 00:54:23.920
legalized recreationally, that someone be required to go through some
1010
00:54:24.000 --> 00:54:26.519
kind of just like to get a driver's license, go
1011
00:54:26.599 --> 00:54:28.960
to some kind of training and take a test, at
1012
00:54:29.039 --> 00:54:30.840
least pass the test, and of course people could gain
1013
00:54:30.880 --> 00:54:32.679
it in this and that, but still on the whole,
1014
00:54:33.039 --> 00:54:36.880
people would get some basic education, harm reduction education. So
1015
00:54:37.280 --> 00:54:40.880
if they're going to use psychaltics for personal exploration growth,
1016
00:54:40.920 --> 00:54:43.119
they would at least be more well informed if there
1017
00:54:43.199 --> 00:54:44.079
wasn't something like this.
1018
00:54:44.639 --> 00:54:48.599
I think that's a phenomenal idea. Yeah, we definitely so
1019
00:54:49.320 --> 00:54:52.840
in the training of therapists, you know, one of the
1020
00:54:52.960 --> 00:54:58.719
key controversial aspects of it is therapist self experience a
1021
00:54:58.840 --> 00:55:01.239
drug that they're going to give to the patients. Now,
1022
00:55:01.760 --> 00:55:04.360
for example, you would probably never take ice skating lessons
1023
00:55:04.360 --> 00:55:06.679
from somebody that never ice skated. You would never go
1024
00:55:06.719 --> 00:55:09.760
to an ayahuasca shaman that had never done ayahuasca. You
1025
00:55:09.800 --> 00:55:13.079
wouldn't go take flying lessons from somebody that never flew
1026
00:55:13.119 --> 00:55:16.440
a plane. Now psychiatrists will say, oh, I give ECT
1027
00:55:16.559 --> 00:55:20.039
electric convulsive therapy, and I give antipsychotics to my patients,
1028
00:55:20.039 --> 00:55:22.400
and I don't need to take them myself, And in
1029
00:55:22.440 --> 00:55:25.000
that case they're right, they don't, because what they're talking
1030
00:55:25.039 --> 00:55:28.679
about is that the ECT is the therapy. The antipsychotics
1031
00:55:28.719 --> 00:55:31.920
are the medicine. They're the therapy. But in psychedelica syst
1032
00:55:31.920 --> 00:55:34.840
the therapy the therapist is part of the treatment. They're
1033
00:55:34.880 --> 00:55:37.559
part of the medicine, They're part of what's helping people
1034
00:55:37.559 --> 00:55:39.920
get better. I think they're more important than the MDMA.
1035
00:55:40.519 --> 00:55:42.400
That's what we said that forty percent of people in
1036
00:55:42.400 --> 00:55:44.599
our study had done MDMA, but they still had PTSD.
1037
00:55:45.320 --> 00:55:49.000
So I think this idea of how do we train therapists,
1038
00:55:49.039 --> 00:55:51.440
and this idea of having them have their own self
1039
00:55:51.480 --> 00:55:55.480
experience is really important. I think the harm reduction what
1040
00:55:55.519 --> 00:55:57.719
we want to do is sort of expand the culture.
1041
00:55:57.800 --> 00:56:00.880
So how do we move to a post probish world?
1042
00:56:01.000 --> 00:56:04.559
And also how do I sort of balance two different things.
1043
00:56:04.559 --> 00:56:08.800
One is MDMA should become a medicine. Administered only under
1044
00:56:08.840 --> 00:56:12.800
direct supervision of therapists who were specially trained, with all
1045
00:56:12.840 --> 00:56:15.639
of that covered by insurance. On the one hand, and
1046
00:56:15.719 --> 00:56:17.159
on the other hand, I'm saying, hey, it should be
1047
00:56:17.199 --> 00:56:18.880
legal for people to just be able to get on
1048
00:56:18.880 --> 00:56:22.079
their own as a fundamental human right to explore their consciousness.
1049
00:56:22.159 --> 00:56:24.159
That will be a lot less risky, I mean a
1050
00:56:24.199 --> 00:56:26.920
lot riskier to just have people. But I think that
1051
00:56:27.360 --> 00:56:30.239
the drug war is worse. But what I really liked
1052
00:56:30.440 --> 00:56:33.159
was your focus on a license. And I think that
1053
00:56:33.320 --> 00:56:35.519
is the key, and we don't hear about it enough,
1054
00:56:35.920 --> 00:56:39.719
but I've talked about licensed legalization, and the idea here
1055
00:56:39.800 --> 00:56:42.079
is that let's say you're a drunk driver and you
1056
00:56:42.119 --> 00:56:46.119
get pulled over for DUI and you lose your driver's license. Well,
1057
00:56:46.639 --> 00:56:48.199
you can go to a liquor store, you can go
1058
00:56:48.280 --> 00:56:50.199
to a bar, and you can still get alcohol. You
1059
00:56:50.199 --> 00:56:52.559
can still get into your car, drive drunk and kill people.
1060
00:56:53.000 --> 00:56:56.199
But if you had a license to buy alcohol, and
1061
00:56:56.239 --> 00:56:59.960
this license was basically simple to get, the main point
1062
00:57:00.159 --> 00:57:02.679
is that you could lose it if you misbehave. And
1063
00:57:02.719 --> 00:57:05.519
we all know how quickly people can check our credit
1064
00:57:05.519 --> 00:57:07.840
cards for us to pay for stuff. It takes seconds
1065
00:57:08.320 --> 00:57:11.239
you know, it's extremely fast. So I like the idea
1066
00:57:11.519 --> 00:57:13.960
very much, but there's very few people talking about a
1067
00:57:14.039 --> 00:57:17.719
license to do cannabis, a license to do alcohol, and
1068
00:57:17.760 --> 00:57:20.800
then you would have different licenses to do psychedelics and
1069
00:57:20.880 --> 00:57:23.320
all these drugs, and I think furthermore, heroin, cocaine, all
1070
00:57:23.320 --> 00:57:26.119
these drugs should be made legal with licenses and with
1071
00:57:26.559 --> 00:57:31.519
proper support, and with harm reduction and opportunities for treatment
1072
00:57:31.559 --> 00:57:33.639
on demand. When you treat people as humans, a lot
1073
00:57:33.679 --> 00:57:36.480
of these people will want treatment. They don't necessarily want
1074
00:57:36.480 --> 00:57:39.280
to stay addicted to drugs. But when you push them underground,
1075
00:57:39.400 --> 00:57:41.920
you push them awave from help. That's not the way
1076
00:57:41.920 --> 00:57:43.840
to get the best results, and then you fuel this
1077
00:57:44.039 --> 00:57:48.199
vast criminal underground. And so I think licensed legalization is
1078
00:57:48.280 --> 00:57:51.840
kind of this midway between Oh, people think, oh, everybody
1079
00:57:51.840 --> 00:57:54.039
can get it for any reason, and that's too dangerous.
1080
00:57:54.440 --> 00:57:57.239
But the license makes it so that if people misbehave
1081
00:57:57.360 --> 00:57:59.800
under the influence of the drug, you've now made it
1082
00:57:59.840 --> 00:58:02.159
hard for them to get that drug, And that just
1083
00:58:02.199 --> 00:58:05.239
makes logical sense. The one main argument I've heard against
1084
00:58:05.239 --> 00:58:08.920
this idea is that then we know how governments switch
1085
00:58:08.960 --> 00:58:12.199
all the time and policies switch, So if you have
1086
00:58:12.280 --> 00:58:13.880
a license, then you've got a list of all the
1087
00:58:13.880 --> 00:58:16.639
people that are using this drug, say it's marijuana or MPTMA.
1088
00:58:16.679 --> 00:58:19.079
And then government shifts and now all of a sudden,
1089
00:58:19.159 --> 00:58:22.519
the new government, which as marijuana, is a list of
1090
00:58:22.559 --> 00:58:24.679
all the people that used it in the past. Now
1091
00:58:25.119 --> 00:58:28.519
they still can go after credit card records to see
1092
00:58:28.559 --> 00:58:30.920
where people have shopped. You know, there's still a lot
1093
00:58:30.920 --> 00:58:33.719
of information for them to tell who's who. But that's
1094
00:58:33.760 --> 00:58:37.320
the main reasons I think I've heard against licensed legalization.
1095
00:58:37.440 --> 00:58:41.039
But I'm curious where you started thinking about that, because
1096
00:58:41.079 --> 00:58:42.800
there's not that many people that think about that.
1097
00:58:43.400 --> 00:58:46.239
Yeah, it just occurred to me, and it's come up
1098
00:58:46.280 --> 00:58:49.199
around other things. There are many things that we do
1099
00:58:49.280 --> 00:58:52.519
in society that we don't need training for, have a
1100
00:58:52.599 --> 00:58:55.719
license for, and maybe they're just considered natural human right.
1101
00:58:55.800 --> 00:58:57.800
But the weather. There's a lot of issues. I mean,
1102
00:58:57.840 --> 00:58:59.760
one that has come out probably get in trouble saying this,
1103
00:58:59.800 --> 00:59:01.719
but one that's come up for me is is the
1104
00:59:01.760 --> 00:59:05.039
whole world of recreational bicycling. You know, and I've been
1105
00:59:05.079 --> 00:59:08.519
a recreational bicyclist, not avid, but have been. But you know,
1106
00:59:08.559 --> 00:59:12.360
we're asked to share the roads and if thrivers misbehave
1107
00:59:12.599 --> 00:59:15.119
somebody can get their license number and they will quickly
1108
00:59:15.159 --> 00:59:16.920
be in trouble and report it and be in trouble.
1109
00:59:17.159 --> 00:59:20.880
A bicyclist completely, you know, off the grid. There's no
1110
00:59:21.000 --> 00:59:23.880
way to track nothing, right, And so you know, if
1111
00:59:23.960 --> 00:59:26.880
people had to get a license to some education around
1112
00:59:26.960 --> 00:59:29.320
riding a bicycle on the roads, had to have a
1113
00:59:29.320 --> 00:59:31.880
little license plate, that would help pay for the you
1114
00:59:31.920 --> 00:59:34.119
know the thing. But you know, I mean even today
1115
00:59:34.159 --> 00:59:37.039
now we get kids out on the streets with electric scooters,
1116
00:59:37.480 --> 00:59:41.719
no license required. You know, I see families a bicycle
1117
00:59:41.800 --> 00:59:44.320
going down the street pulling a little trailer behind it
1118
00:59:44.360 --> 00:59:46.400
with an infinet it out on the street mixed with
1119
00:59:46.480 --> 00:59:49.000
cars and it's legal. You know. So there's a lot
1120
00:59:49.000 --> 00:59:51.320
of these things that are kind of nonsensical, and you know,
1121
00:59:51.360 --> 00:59:53.880
and it's again, you know, I'm not you know, I
1122
00:59:53.920 --> 00:59:55.440
have a part of my brain is a bit of
1123
00:59:55.440 --> 00:59:58.119
a you know, not an anarchist, but so a little
1124
00:59:58.119 --> 00:59:59.840
bit of a living and so the idea of over
1125
01:00:00.000 --> 01:00:02.360
regulating society and having to have permits to do everything
1126
01:00:02.440 --> 01:00:04.440
is not that attractive either. But with some of these
1127
01:00:04.440 --> 01:00:07.079
things that you know, whether there are risks involved, how
1128
01:00:07.119 --> 01:00:09.440
do we try to reduce harm and assure that the
1129
01:00:09.519 --> 01:00:11.440
consumer is well educated.
1130
01:00:11.079 --> 01:00:11.960
I think is the point.
1131
01:00:12.159 --> 01:00:14.480
And also I think you framed it quite beautifully. How
1132
01:00:14.519 --> 01:00:18.679
do we envision a post prohibition world and what does
1133
01:00:18.719 --> 01:00:20.519
that look like? And how do we do that safely
1134
01:00:20.559 --> 01:00:23.239
so that we're not continuing these cycles of backlash and
1135
01:00:23.239 --> 01:00:25.719
them problems and so forth. And it'll never be able
1136
01:00:25.760 --> 01:00:27.599
to be perfect, but everything we can do to make
1137
01:00:27.639 --> 01:00:29.920
it as good and as risky as possible.
1138
01:00:30.440 --> 01:00:32.239
Yeah, I think what we need is pure drug Well,
1139
01:00:32.280 --> 01:00:35.599
first off, we need honest drug education at schools we
1140
01:00:35.639 --> 01:00:39.119
should not have. Then we need pure drugs so that
1141
01:00:39.119 --> 01:00:41.639
people are not dying from contaminated drugs or they know
1142
01:00:41.719 --> 01:00:44.159
the doses, they're not taking drug that all of a sudden,
1143
01:00:44.199 --> 01:00:46.159
is twice as strong as they thought it was. Then
1144
01:00:46.239 --> 01:00:49.880
we need harm reduction trainings for people to provide peer
1145
01:00:49.920 --> 01:00:53.840
support for each other when sechno experiences often can get difficult,
1146
01:00:54.039 --> 01:00:55.960
but it's not a sign that it's a bad trip.
1147
01:00:56.320 --> 01:00:59.079
You need to work on what's difficult. And then also
1148
01:00:59.679 --> 01:01:02.400
so we do the Zendo Project at berning Man. We
1149
01:01:02.440 --> 01:01:05.960
have hundreds of volunteers to provide peer support to people
1150
01:01:06.039 --> 01:01:08.159
that have difficult trips. This year, we had over four
1151
01:01:08.239 --> 01:01:11.360
hundred people come for help. Even in the sort of
1152
01:01:11.400 --> 01:01:14.480
sophisticated environment of Burning Man, where people you presume are
1153
01:01:14.519 --> 01:01:17.719
comfortable with psychedelics, four hundred people said that they had
1154
01:01:17.800 --> 01:01:20.679
experiences that were deeper and more profound or more troublesome
1155
01:01:20.719 --> 01:01:23.760
than they thought, and they came for assistance with this
1156
01:01:23.800 --> 01:01:26.159
group of peer support. And then we need treatment on
1157
01:01:26.199 --> 01:01:28.639
demand for those people that do get addicted to something,
1158
01:01:29.000 --> 01:01:31.719
whatever it happens to be, and they can get treatment
1159
01:01:31.880 --> 01:01:33.599
if they want it, and those I think will make
1160
01:01:33.679 --> 01:01:37.119
post prohibition world work. But the drug war is so
1161
01:01:37.280 --> 01:01:40.400
counterproductive and so negative that we can switch right away.
1162
01:01:40.519 --> 01:01:43.199
If we could, even without all these policies in place,
1163
01:01:43.199 --> 01:01:46.320
they would still be a benefit to society. But I
1164
01:01:46.360 --> 01:01:48.639
do encourage you to sort of keep talking about the
1165
01:01:48.800 --> 01:01:51.119
license idea because it's a really good one.
1166
01:01:51.440 --> 01:01:53.280
Well, I'll be there in Denver in June, so I'll
1167
01:01:53.280 --> 01:01:56.280
see if I can get anybody interested there. I was
1168
01:01:56.280 --> 01:01:58.360
there last year and it was quite an amazing event.
1169
01:01:59.000 --> 01:02:01.320
So I wonder about well, you know, we're talking about
1170
01:02:01.320 --> 01:02:05.679
cultural change, and even in political change and mindset change,
1171
01:02:05.719 --> 01:02:09.679
heartset change, and so a lot of the psychedelic medicines
1172
01:02:09.960 --> 01:02:15.079
can produce trans personal experiences that have in many cases
1173
01:02:15.199 --> 01:02:19.800
changed someone's mindset, heartset, world view. And so I'm wondering
1174
01:02:19.840 --> 01:02:23.119
about the role of that if there's some you know,
1175
01:02:23.159 --> 01:02:24.920
I mean, back in the sixties, many of us had
1176
01:02:24.920 --> 01:02:26.800
the idea, if we could just give all the influential
1177
01:02:26.840 --> 01:02:29.119
people and leaders in the worldality.
1178
01:02:28.599 --> 01:02:30.000
The whole world, change it all be beautiful.
1179
01:02:30.000 --> 01:02:32.519
It didn't quite work out that way, but still I
1180
01:02:32.559 --> 01:02:35.280
think there is the idea that there's something in the
1181
01:02:35.320 --> 01:02:39.920
world of psychedelics that is related to changes in consciousness
1182
01:02:40.000 --> 01:02:42.880
that could be positive for the world. Care about the environment,
1183
01:02:42.960 --> 01:02:46.480
care about others, profound it or connectedness, you know, all
1184
01:02:46.559 --> 01:02:48.719
kinds of things. And so I'm curious about your thoughts
1185
01:02:48.719 --> 01:02:51.920
about that long range or even in the short term.
1186
01:02:52.159 --> 01:02:54.920
Well, that's what really motivated me at eighteen in nineteen
1187
01:02:54.960 --> 01:02:57.800
seventy two, is to devote my life to psychedelics. Now,
1188
01:02:57.880 --> 01:03:00.920
that was to help normalize that. I want to talk
1189
01:03:00.960 --> 01:03:03.519
about the astronauts going to the moon. And we just
1190
01:03:03.559 --> 01:03:06.119
got a quote I just read earlier today about one
1191
01:03:06.119 --> 01:03:10.519
of the first private funded spacewalk in history, a billionaire guy,
1192
01:03:10.519 --> 01:03:12.480
and he said, oh, you know, from up here, the
1193
01:03:12.559 --> 01:03:15.039
Earth looks like this incredibly beautiful thing. We have got
1194
01:03:15.039 --> 01:03:16.639
a lot of problems on Earth, but from up here,
1195
01:03:16.679 --> 01:03:20.719
it just looks like this super rare, beautiful thing. The astronauts,
1196
01:03:20.760 --> 01:03:23.239
some of them Edgar Mitchell in particular, talked about seeing
1197
01:03:23.280 --> 01:03:27.320
the Earth from space and how that changed his mindset.
1198
01:03:27.599 --> 01:03:30.280
So I think this idea that you see the Earth
1199
01:03:30.320 --> 01:03:32.519
as one thing. You don't see the religions, you don't
1200
01:03:32.559 --> 01:03:34.559
see the borders, you don't see the races, you don't
1201
01:03:34.599 --> 01:03:37.480
see the genders. You just see that we're all living
1202
01:03:37.559 --> 01:03:42.159
on this one little, miraculous little planet that somehow has
1203
01:03:42.239 --> 01:03:44.679
life on it, and we're not aware of life anywhere else,
1204
01:03:45.159 --> 01:03:47.480
but we're all part of the same thing. And if
1205
01:03:47.480 --> 01:03:50.519
you can see it that way, the astronauts have said
1206
01:03:50.519 --> 01:03:54.719
that's changed their opinion. So this psychedelic, mystical experience, feeling
1207
01:03:54.719 --> 01:03:58.079
that your unity, you're part of everything, going beyond your
1208
01:03:58.119 --> 01:04:01.159
ego sense, which is there to protect this body, but
1209
01:04:01.480 --> 01:04:03.519
going beyond that, you see this body as part of
1210
01:04:03.559 --> 01:04:06.400
billions of years of history, and you know that there
1211
01:04:06.400 --> 01:04:09.480
were more like ants in an anhill than you know,
1212
01:04:09.639 --> 01:04:14.079
unique individuals. That there's this sentence that if we're all
1213
01:04:14.079 --> 01:04:17.039
in it together. How do you dehumanize other people because
1214
01:04:17.039 --> 01:04:18.960
we're all the same. How do you say, oh, nature,
1215
01:04:19.039 --> 01:04:21.920
let's just throw trash out because it's out. Well, there's
1216
01:04:21.920 --> 01:04:24.360
no out in nature, you know, and we're all responsible
1217
01:04:24.440 --> 01:04:26.599
for global warming, and how do we deal with it?
1218
01:04:26.679 --> 01:04:28.920
So I do think that there's been a couple of
1219
01:04:28.920 --> 01:04:31.960
studies have shown that psilocybin mystical experiences lead to a
1220
01:04:32.079 --> 01:04:37.000
nature relatedness, increased nature relatedness, and there's some other studies
1221
01:04:37.079 --> 01:04:40.400
that talk about, you know, this relationship between the mystical
1222
01:04:40.440 --> 01:04:44.599
experience and therapeutic outcomes. The more you feel connected in
1223
01:04:44.639 --> 01:04:47.320
this way to everything, the more people are able to
1224
01:04:47.320 --> 01:04:51.440
get over depression and anxiety OCD addiction. So I think
1225
01:04:51.480 --> 01:04:56.320
that this kind of cultural change consciousness shift. Clearly we're
1226
01:04:56.320 --> 01:04:59.079
in danger as a species. You know, the amount of
1227
01:04:59.119 --> 01:05:04.199
extinctions that are going on now is unprecedented, and the
1228
01:05:04.239 --> 01:05:07.039
what we're doing to the environment and the rapid change
1229
01:05:07.119 --> 01:05:12.159
that is happening now is also unprecedented. And the way
1230
01:05:12.199 --> 01:05:14.119
I would look at it is, let's just talk about
1231
01:05:14.119 --> 01:05:16.840
Galileo and Copernicus. You know, So there was the thing
1232
01:05:16.920 --> 01:05:19.199
that the Earth was the center of the universe, right
1233
01:05:19.280 --> 01:05:22.079
and then Galileo and Copernicus were like, no, that's not
1234
01:05:22.119 --> 01:05:26.039
the case. Galileo was arrested, was under house arrest by
1235
01:05:26.079 --> 01:05:29.639
the Church because they didn't like this idea that the
1236
01:05:29.679 --> 01:05:33.079
Earth was not the center of the universe. Father Bruno,
1237
01:05:33.239 --> 01:05:36.920
who was both into the plant medicines and into studies
1238
01:05:36.960 --> 01:05:39.760
of Copernicus, was burned at the stake by the Church,
1239
01:05:40.440 --> 01:05:43.400
and at the time that the Inquisition sentenced him, he said,
1240
01:05:43.519 --> 01:05:47.719
your fear in sentencing me is greater than my fear
1241
01:05:47.840 --> 01:05:52.400
in being sentenced. The people's worldview was so integral to
1242
01:05:52.440 --> 01:05:54.760
who they were, and it was so shattering that, oh,
1243
01:05:54.880 --> 01:05:56.800
you know, we're not the center of the universe. So
1244
01:05:56.960 --> 01:06:01.079
I think what we have now is this crisis. EO.
1245
01:06:01.159 --> 01:06:03.679
Wilson said it really well. He said that real problem
1246
01:06:03.719 --> 01:06:10.119
with humanity is that we have paleolithic emotions with medieval institutions,
1247
01:06:10.159 --> 01:06:15.119
with godlike technologies. God have the emotions and spiritual capacity
1248
01:06:15.159 --> 01:06:17.840
to deal with the world that we've created through our minds,
1249
01:06:17.880 --> 01:06:22.119
through our science, and so we need this evolution of consciousness.
1250
01:06:22.519 --> 01:06:25.400
And I think that we're at a stage in humanity where,
1251
01:06:25.440 --> 01:06:29.000
through the Internet and through satellites and through where everybody
1252
01:06:29.039 --> 01:06:33.039
is and through global warming, people are thinking more globally.
1253
01:06:33.079 --> 01:06:35.639
And then I want to talk about humanistic psychology and
1254
01:06:35.639 --> 01:06:39.400
Abraham Manislow. So most people are taught in school about
1255
01:06:39.400 --> 01:06:42.360
the hierarchy of needs, this triangle, this hierarchy of needs.
1256
01:06:42.760 --> 01:06:45.719
It starts with your survival needs and your belonging needs,
1257
01:06:45.719 --> 01:06:47.559
and then your self esteem, and it goes on and on.
1258
01:06:48.000 --> 01:06:51.599
And the highest point that people are taught is self actualization.
1259
01:06:52.159 --> 01:06:55.119
That this is almost like the libertarian dream that you know,
1260
01:06:55.239 --> 01:06:58.519
you become your full self. That's this hierarchy of needs.
1261
01:06:59.079 --> 01:07:01.880
And this this was in the sixties, the mid sixties
1262
01:07:01.880 --> 01:07:05.400
that Abraham Maslow developed this. However, in the end of
1263
01:07:05.440 --> 01:07:09.199
the sixties he changed it, and people are not taught
1264
01:07:09.440 --> 01:07:13.360
what he changed. But what he changed is above self
1265
01:07:13.400 --> 01:07:18.079
actualization is something new, and he called it self transcendence.
1266
01:07:18.760 --> 01:07:21.599
It is this exact thing you're talking about, this mysticalhostre,
1267
01:07:21.679 --> 01:07:24.239
the sense we're big connected to something bigger than ourselves.
1268
01:07:24.760 --> 01:07:28.519
That's I think the consciousness shift that humanity needs to make.
1269
01:07:29.000 --> 01:07:31.800
You know, many people humanity are down at this lower
1270
01:07:31.920 --> 01:07:35.800
level of survival because we have inequitable access to resources,
1271
01:07:35.840 --> 01:07:38.960
we have exploitation, and we have greed many, many people
1272
01:07:39.000 --> 01:07:43.000
are barely surviving in poverty. So it's hard to think
1273
01:07:43.039 --> 01:07:45.840
about self transcendence when you're starving to death or you know,
1274
01:07:45.880 --> 01:07:48.280
so you have to satisfy these needs. But if we
1275
01:07:48.280 --> 01:07:50.360
are to get to more and more people that believed
1276
01:07:50.360 --> 01:07:55.039
in self transcendence, there are enough resources to make everybody
1277
01:07:55.039 --> 01:07:57.199
have a comfortable life. There's more than enough food that
1278
01:07:57.239 --> 01:08:00.880
we can produce, there's more than enough shelter. The capacity
1279
01:08:00.880 --> 01:08:03.840
that humans have to take care of everybody, and to
1280
01:08:04.159 --> 01:08:08.519
take collective action against nuclear weapons, against global warming, all
1281
01:08:08.559 --> 01:08:12.559
of that is there. The opportunity is incredible, but we
1282
01:08:12.599 --> 01:08:16.279
need this consciousness shift. And I think that psychedelic in
1283
01:08:16.399 --> 01:08:19.920
the proper context can play a major role in this
1284
01:08:20.079 --> 01:08:22.840
sort of consciousness shift, but it's not the only way.
1285
01:08:22.920 --> 01:08:25.199
So I was at a meeting the other day and
1286
01:08:25.399 --> 01:08:29.279
somebody was debating is MDMA a psychedelic? They're like, oh,
1287
01:08:29.520 --> 01:08:31.560
And they said, oh, no, MDMA is not a psychedelic.
1288
01:08:31.720 --> 01:08:34.680
You know, only the classic psychedelics that dissolve your ego, LSD,
1289
01:08:34.720 --> 01:08:37.159
psilocybin and things like that are And I said, no.
1290
01:08:37.640 --> 01:08:40.560
You know what I've been doing to try to normalize
1291
01:08:40.560 --> 01:08:44.800
psychedelics in people's minds is to broaden the definition of psychedelic,
1292
01:08:44.960 --> 01:08:48.720
which it was meant to mean mind manifesting, and so
1293
01:08:49.479 --> 01:08:54.199
hyperventilation is psychedelic dreams or psychedelic. So you know, all
1294
01:08:54.239 --> 01:08:56.960
of this is and we all have some connection to
1295
01:08:57.000 --> 01:08:59.680
our dreams or you know, just the thought that through
1296
01:08:59.720 --> 01:09:02.279
all you're breathing, you're going to have a psychnolic experience.
1297
01:09:02.760 --> 01:09:06.039
What it means is it's in ourselves. It's not this
1298
01:09:06.199 --> 01:09:08.840
these experiences in this drug. And it's also something you
1299
01:09:08.880 --> 01:09:11.199
can get from looking at Earth from space. So I
1300
01:09:11.239 --> 01:09:15.319
think that this consciousness shift is necessary for human survival,
1301
01:09:15.880 --> 01:09:17.880
and whether we're going to make it or not is
1302
01:09:17.960 --> 01:09:21.159
really uncertain. You know, people are talking about AI is
1303
01:09:21.199 --> 01:09:23.479
going to destroy the world, you know, but we are
1304
01:09:23.520 --> 01:09:26.359
the ones that program AI. So it's not AI destroying things,
1305
01:09:26.399 --> 01:09:29.119
it's us, if that's what happens. I do think we
1306
01:09:29.239 --> 01:09:32.680
need this consciousness shift. And when I well, I'll say
1307
01:09:32.680 --> 01:09:35.680
Albert Off. Albert Einstein had this great quote as well,
1308
01:09:36.119 --> 01:09:38.960
which was the splitting of the atom has changed everything
1309
01:09:39.119 --> 01:09:42.720
except our mode of thinking, and hence we drift towards
1310
01:09:42.800 --> 01:09:47.039
unparalleled catastrophe. What shall be required if mankind is to
1311
01:09:47.159 --> 01:09:50.000
survive as a whole new mode of thinking. Now, what
1312
01:09:50.159 --> 01:09:52.479
is that new mode of thinking? I think it's collective,
1313
01:09:52.640 --> 01:09:55.680
it's mystical, it's how we're all in it together. That's
1314
01:09:55.720 --> 01:09:58.399
the consciousness shift that we need, and psychedelics can help
1315
01:09:58.439 --> 01:09:58.680
with that.
1316
01:09:59.119 --> 01:10:01.760
Yeah, we clearly seem to be a real inflection point.
1317
01:10:01.840 --> 01:10:05.000
Maybe decades or centuries earlier a shift and consciousness would
1318
01:10:05.000 --> 01:10:08.000
have been nice, but now it seems somewhat existential that
1319
01:10:08.079 --> 01:10:11.199
we need this now to address the very complex problems
1320
01:10:11.199 --> 01:10:14.640
we're facing. And so the psychaic experience in whatever form,
1321
01:10:14.680 --> 01:10:18.479
whether it's through breath work or nature experiences or psychaic medicine,
1322
01:10:18.520 --> 01:10:21.560
seems some kind of transpersonal experiences seems to be so
1323
01:10:21.760 --> 01:10:26.159
necessary to create that collective individual and collective shift and consciousness.
1324
01:10:26.399 --> 01:10:30.000
Maybe just one last question I'd have, So if the
1325
01:10:30.119 --> 01:10:34.279
FDA had approved MDMA, you know, my question is kind
1326
01:10:34.279 --> 01:10:36.680
of I'm in a narrative bit, but where would we
1327
01:10:36.720 --> 01:10:39.560
be now and what would we be doing? And you know, visioning,
1328
01:10:39.600 --> 01:10:41.760
hoping whether the way it works out. They don't just
1329
01:10:41.880 --> 01:10:44.199
narrowly approve just the drug and it doesn't some of
1330
01:10:44.239 --> 01:10:46.680
the dangers of how lycos and FDA may approve it,
1331
01:10:46.680 --> 01:10:48.199
but hopefully if it works out the way you would
1332
01:10:48.239 --> 01:10:50.000
like it to work out in three years and the
1333
01:10:50.039 --> 01:10:53.119
outcome you were hoping for now occurs. But let's say
1334
01:10:53.159 --> 01:10:55.800
it had occurred. One of the challenges is to roll
1335
01:10:55.800 --> 01:10:59.960
this out in any way that's equitable, it's distributable, that's accessible,
1336
01:11:00.159 --> 01:11:03.439
it's not too expensive that insurance will cover, that can
1337
01:11:03.479 --> 01:11:07.279
be widely distributed. And so one of the one of
1338
01:11:07.319 --> 01:11:09.960
the suggestions has been group therapy as opposed to just
1339
01:11:10.039 --> 01:11:13.199
individual therapies. And you know, and then at what level
1340
01:11:13.239 --> 01:11:16.039
of licensures required to be a guide? And you know,
1341
01:11:16.079 --> 01:11:18.520
in the many of the clinical trialogy had two licensed
1342
01:11:18.520 --> 01:11:22.640
clinicians there. That would be extraordinarily expensive. So what would
1343
01:11:22.680 --> 01:11:24.960
you what do you envision would be happening right now
1344
01:11:25.039 --> 01:11:27.439
if it had been approved now and over the next
1345
01:11:27.479 --> 01:11:29.960
six months to a year, And what would you envisioned
1346
01:11:30.000 --> 01:11:30.920
that needs to happen?
1347
01:11:30.920 --> 01:11:35.560
Then? Well, okay, so let's say fdaight approved. One of
1348
01:11:35.600 --> 01:11:38.359
the first things that would have been done and should
1349
01:11:38.359 --> 01:11:41.399
have been done allowed to and this is so clearly commercial,
1350
01:11:42.079 --> 01:11:46.520
is a dose response safety study of people on SSRIs
1351
01:11:46.560 --> 01:11:50.800
with PTSD giving them higher doses of MDMA. So we
1352
01:11:50.880 --> 01:11:56.000
require we licos maps. The research with MDMA requires people
1353
01:11:56.119 --> 01:12:00.439
to taper off of their psychiatric medications. It's true that
1354
01:12:00.479 --> 01:12:02.520
they blunt the effect of MDMA. There's a lot of
1355
01:12:02.600 --> 01:12:06.600
underground evidence and anecdotal reports and some theoretical reasons to
1356
01:12:06.600 --> 01:12:09.479
think that when you do higher doses of MDMA you
1357
01:12:09.640 --> 01:12:13.159
overwhelm the blunting effects, but you don't get serotonin syndrome.
1358
01:12:13.600 --> 01:12:17.239
So that's just from a purely commercial point of view.
1359
01:12:17.239 --> 01:12:20.279
There's loads of people that don't really want to taper
1360
01:12:20.279 --> 01:12:23.640
off their medicines in order to get treated for PTSD
1361
01:12:23.680 --> 01:12:25.880
with MDMA. Yeah, I mean you can give to people
1362
01:12:26.000 --> 01:12:28.439
on their medicines more and more. It's sturning out psilocybein
1363
01:12:28.520 --> 01:12:31.039
you can give to people on their medicines. That's one thing.
1364
01:12:31.560 --> 01:12:33.359
Another thing that would be happening, and I'll get to
1365
01:12:33.399 --> 01:12:36.880
the group therapy, But the FDA has blocked licos and
1366
01:12:37.039 --> 01:12:41.199
maps before that from studying adolescence with PTSD or people
1367
01:12:41.319 --> 01:12:44.479
under eighteen with PTSD. So far, it's only been eighteen
1368
01:12:44.560 --> 01:12:47.000
or over, and if it was approved, it was only
1369
01:12:47.000 --> 01:12:50.159
approved for eighteen or over. However, the FDA indicated that
1370
01:12:50.239 --> 01:12:53.119
if they would approve it, then they would require studies
1371
01:12:53.119 --> 01:12:56.720
and adolescents, which are called pediatric studies. I think that's
1372
01:12:56.800 --> 01:12:59.439
really really important. The closer you can treat people to
1373
01:12:59.479 --> 01:13:03.359
the trauma, the less damage there is, the more benefit
1374
01:13:03.399 --> 01:13:06.000
there is. And so I think there would be adolescent
1375
01:13:06.039 --> 01:13:09.920
studies happening at FDA. Happened as far as group therapy now,
1376
01:13:10.479 --> 01:13:14.119
there is this incredible project that's being developed in Israel
1377
01:13:14.239 --> 01:13:17.520
for group therapy, for exploring that. There's a study the
1378
01:13:17.680 --> 01:13:22.760
Dutch well Accually, the Australian government is now funding research
1379
01:13:22.880 --> 01:13:27.079
with two hundred people in group therapy with climate related
1380
01:13:27.159 --> 01:13:30.880
PTSD from flood in England. They already going to do
1381
01:13:30.960 --> 01:13:34.640
two therapists for three people. And at the Portland Oregon
1382
01:13:34.720 --> 01:13:38.399
VA there is group therapy taking place right now and
1383
01:13:38.399 --> 01:13:41.680
it's four therapists for six people with PTSD and there
1384
01:13:41.720 --> 01:13:44.760
they get one MDMA session individually and then a group session.
1385
01:13:45.199 --> 01:13:48.000
In the Israel study, i'll be group sessions in the
1386
01:13:48.079 --> 01:13:51.039
Australian study. I'm not sure, so I think there would
1387
01:13:51.079 --> 01:13:53.359
be even more work, but there is some work with
1388
01:13:53.720 --> 01:13:57.079
group therapy. The other thing is that the FDA is
1389
01:13:57.079 --> 01:13:59.199
a signal. If they approve it, it's a signal to
1390
01:13:59.239 --> 01:14:01.800
countries all over the world that it's okay. So our
1391
01:14:01.840 --> 01:14:05.800
international global humanitarian projects are made more difficult now because
1392
01:14:05.920 --> 01:14:08.479
FDA did not say approval. So just to give you
1393
01:14:08.560 --> 01:14:13.279
an example, in Armenia, which has leftover terrible laws from Russia.
1394
01:14:13.319 --> 01:14:17.039
In Ukraine, the story is similar. You cannot do research
1395
01:14:17.079 --> 01:14:19.960
with drugs and Schedule one. Now. In Ukraine they're going
1396
01:14:20.039 --> 01:14:22.920
to have a meeting in November. They have such PTSD
1397
01:14:23.000 --> 01:14:26.039
problems because of the Russian invasion that they're willing to
1398
01:14:26.079 --> 01:14:30.600
think about different modifications of their existing systems. So there's
1399
01:14:30.600 --> 01:14:32.560
going to be a meeting in November and Ukraine about
1400
01:14:32.680 --> 01:14:36.600
ending this prohibition of research with MDMA or psilocybin or
1401
01:14:36.640 --> 01:14:38.960
other schedule on drugs. But if FDA said yes, it
1402
01:14:38.960 --> 01:14:42.239
would be rescheduled and then that would be easy. Armenia
1403
01:14:42.600 --> 01:14:44.359
he can through some stuff with Schedule one, but I
1404
01:14:44.359 --> 01:14:46.840
haven't heard about regal efforts to try to change that.
1405
01:14:47.479 --> 01:14:52.319
Everywhere we go in Somaliland, Rwanda, Kenya, South Africa. We're
1406
01:14:52.359 --> 01:14:55.119
going to do a training of therapists in Abudhabi. In Dubai.
1407
01:14:55.600 --> 01:14:58.239
There's an enormous amount of PTSD in the Arab world
1408
01:14:58.239 --> 01:15:01.680
as well, and we want to treat everybody healing for all.
1409
01:15:02.239 --> 01:15:05.319
But now that FDA didn't say yes, and maybe a
1410
01:15:05.319 --> 01:15:08.000
while before, the people in Abudawi Dubai ready for us
1411
01:15:08.000 --> 01:15:10.399
to do that, to do trainings in the start work.
1412
01:15:10.439 --> 01:15:13.439
A lot of people are ready to go second after FDA,
1413
01:15:13.920 --> 01:15:16.640
but they don't want to go first. So that's the
1414
01:15:16.680 --> 01:15:19.279
real setback from FDA is that if they would have
1415
01:15:19.319 --> 01:15:22.920
gone first, then so many other countries would have gone second,
1416
01:15:23.000 --> 01:15:25.239
and we could have but we will still be able
1417
01:15:25.239 --> 01:15:27.560
to do things around the world. But I do think
1418
01:15:27.600 --> 01:15:29.760
that you're putting your finger on group therapy as I
1419
01:15:29.800 --> 01:15:33.279
think the key factor for access. And I just heard
1420
01:15:33.319 --> 01:15:36.000
a story this morning from some of the Israeli teams
1421
01:15:36.520 --> 01:15:39.239
that you know, I've always felt that individual therapy is
1422
01:15:39.279 --> 01:15:42.079
going to be more effective than group therapy, but that
1423
01:15:42.159 --> 01:15:46.199
the group integration process, you'd be so supportive that that
1424
01:15:46.279 --> 01:15:48.399
can kind of make up for it. But what I
1425
01:15:48.439 --> 01:15:50.880
heard from one of the Israelis this morning was that
1426
01:15:50.960 --> 01:15:54.479
they saw a group session that they thought was so
1427
01:15:54.800 --> 01:15:58.119
profound for the people in the group that they're questioning
1428
01:15:58.159 --> 01:16:02.159
whether group therapy is inferior to individual therapy. They think
1429
01:16:02.159 --> 01:16:04.840
it might even be as good or better in certain circumstances.
1430
01:16:05.319 --> 01:16:07.800
So I think that is the main area of research
1431
01:16:07.840 --> 01:16:11.920
that is still happening even though FDA to know. But
1432
01:16:12.079 --> 01:16:15.560
what is more difficult is the global humanitarian projects and
1433
01:16:15.640 --> 01:16:18.119
what is not happening is the pediatric studies or the
1434
01:16:18.520 --> 01:16:22.119
Bocherswant safety study. With people on SSRIs, well, we'll hope
1435
01:16:22.199 --> 01:16:24.479
for the best with how this rolls out with the FDA.
1436
01:16:24.640 --> 01:16:26.960
And thank you so much for the incredible work you've
1437
01:16:26.960 --> 01:16:31.279
been doing for many decades. This has been incredibly educational, illuminating.
1438
01:16:31.279 --> 01:16:32.319
This will thank you so much.
1439
01:16:32.680 --> 01:16:35.000
Thank you for having me because another thing that is
1440
01:16:35.079 --> 01:16:38.319
so clear with the FDA rejection is that we need
1441
01:16:38.359 --> 01:16:41.319
more public education and that's I want to thank you
1442
01:16:41.359 --> 01:16:43.319
for trying to help you do more of that.
1443
01:16:43.319 --> 01:16:47.119
Absolutely, absolutely, thank you, be well. Thank you for joining
1444
01:16:47.199 --> 01:16:51.319
me on the Radical Responsibility Podcast. Remember, real change happens
1445
01:16:51.319 --> 01:16:54.439
when we commit to our growth, face our challenges with compassion,
1446
01:16:54.560 --> 01:16:58.039
and stay open to transformation. If you found this episode helpful,
1447
01:16:58.279 --> 01:17:00.720
I encourage you to subscribe and help us spread the
1448
01:17:00.760 --> 01:17:04.720
message of healing and personal empowerment. Stay grounded, stay present,
1449
01:17:04.920 --> 01:17:05.920
and stay true to you.
1450
01:17:06.199 --> 01:17:06.680
Take care