Progress of FDA approval of psilocybin, and associated risks and contraindications for use

Progress of FDA approval of psilocybin, and associated risks and contraindications for use

[Roland]: For our immediate therapeutic target,
it’s cancer and it’s this depression and anxiety associated with cancer. Wherein the groups that I’m working with are
in very early stages of communicating with FDA about undertaking a phase three clinical
trial which would be the necessary next step, and if efficacy were demonstrated, then there’s
the potential for approvability of psilocybin as a medication. [Rhonda]: Wow. That was going to be my next question. [Roland]: And were to be approved, we would
see it approved under very constrained conditions. Perhaps the drug would be held by a central
pharmacy. It would be dispensed to clinics that offer
this kind of therapy with clinicians who know how to deliver this therapy because it is
this interaction of context and pharmacology. This is not just an effective of psilocybin. And in fact, there are risks associated with
just taking psilocybin that we really shouldn’t minimize. Those are some of the risks that resulted
in the deep cultural misunderstanding of these compounds and ultimately the removal of them
from clinical research for decades, but we just, actually very recently, completed and
published a large survey study of people who…this was about 2000 people, and we asked them,
have you ever had a bad trip after taking psilocybin mushrooms? And then we asked them to describe their very
worst experience with psilocybin mushrooms. So we don’t have any denominator to know what
the frequency of this sort of thing is, but the results of that are sobering. So if you ask these people what were the consequences
of their worst experience, we have about 10% who say that they may have put themselves
or others at risk of physical harm during the experience. And there’s some percentage of people who
say that they have enduring psychological problems for which they are seeking out psychological
or psychiatric help with a year after the experience. So it suggests that there can be immediate
dangers and we know that, to exposure to psilocybin. People can put themselves at risk. And most often, that occurs in fear or anxiety
responses, but under conditions where people take the compound and they don’t know what
they’re doing, they don’t know what dose they’re getting, they’re not supported, and then people
can end up dying. And so there’s that risk. And then there’s the potential risk of vulnerable
populations, people who may already have pre-existing vulnerabilities to psychotic disorder or to…they
might have personality disorders or some other mood…pre-existing disposition toward mood
disorders that may make them unusually sensitive to potential negative effects of psilocybin. So we really need to footnote all this work
and make sure that the take-home message is, “Great, everybody should take psilocybin mushrooms.” No, there are going to be some people who
are going to truly be hurt and we need to do everything we can to protect people, particularly
young and vulnerable people.


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  2. How exciting! I’ve found benefits from psychedelics all my life! glad you’re interested/sharing what you learn!

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