FDA Panel Rejects MDMA-Aided Therapy for PTSD

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From The New York Times: “An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using the drug commonly known as Ecstasy.

Before the vote, members of the panel raised concerns about the designs of the two studies submitted by the drug’s sponsor, Lykos Therapeutics. Many questions focused on the fact that study participants were by and large able to correctly guess whether they had been given MDMA, also known by the names of Ecstasy or molly.

The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment’s benefits outweighed its risks.

Other panelists expressed concerns over the drug’s potential cardiovascular effects, and possible bias among the therapists and facilitators who guided the sessions and may have positively influenced patient outcomes. A case of misconduct involving a patient and therapist in the study also weighed on some panelists’ minds.”

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4 COMMENTS

  1. To me, this news is disappointing.

    Now, the FDA still might reject the panel’s advice and approve MDMA anyway. That’s what they did with aducanumab, that completely ineffective Alzheimer’s drug that causes brain swelling and bleeding.

    MDMA is clearly lifesaving for some. Hopefully the FDA does end up approving it. However, without the backing of a billion-dollar company, I am not hopeful.

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  2. This is my view based on my experience, so please don’t theoretically interrogate it because it is based on perception, not theory. For me the psychiatric approach to PTSD is totally unrelated to the actual terrain in which the problem occurs, and this is the pattern of psychiatry throughout the mental disorders. I was diagnosed with complex PTSD once and the diagnosis and description does accurately capture a set of psychological and consequent emotional and physical symptoms, but that is where all the truth and relevance ends. The psychiatric theory is based on the brain, which is not the actual terrain that the problem exists for us, and neither do we have anything like the right understanding either of the brain or of the mind that something so crude as a drug could really help it, or a theory really explain it. Can’t you all see the obviousness of all this? It’s as absurd to me as thinking a pill might cure someone’s political liberalism or conservatism, or their tendency to judge or criticise. Perhaps this is where the psychopharmacological bandwagon will drive to next.
    The psychological phenomena itself makes clear what is happening, and it is not merely the problem: it is the solution. But no psychiatrist ever calls it the solution – they try and intervene with drugs that have an insignificant impact on the person but which will convince them that they have tried he only treatment available and therefore there is nothing further they can do.
    This isn’t theoretical for me because it’s how I put away this problem and others mental disorders including psychosis.
    PTSD, which is disturbing and repetitive psycholocal phenomena, generally traumatic complexes, that upsets the emotions and the body and causes disturbances in things like sleeping, eating, mood regulation, anger control and general emotional stability, and I am not the first in finding that the repetitive psychological phenomena of traumatic memories are repeating themselves because they are parts of a traumatic experience that demand to be understood by the brain. Many therapies in all disciplines from psychological to spiritual recognize this and fascilitate, in one way or another, a confrontation with the psychological phenomena. Mindfulness is the most direct confrontation possible, but if the phenomena causes grave emotional distress or dangerous physical or emotional rections, these latter obviously need to be understood and addressed.
    Typically, we don’t know what to do with the traumatic complexes and meories, and typically we try and escape them, because they cause profound emotional disturbances and physical reactions, which happens also when they are in the for of nightmares. These reactions make the observation and understanding and processing of the traumatic phenomena impossible, so it repeats and repeats until it is resolved, and typically there are many more then just the one traumatc complex: it may have many subsections, each of which needs to be observed and understood, and the more painful then less easy it is.
    So in my experience, it is only the simple observation and understanding of traumatic phenomena that puts it away and if someone is unable to do this then they need real help, which for me means support, social affection, the freedom to be who they are, and to go through what they need to go through, without judgement. Alas, we don’t live in a society that makes this possible. We live in a society that causes widespread PTSD and then blames it on the brain. That is my view and I say it as I see it. If all people suffering mental illness did the same, so long as we weren’t regarded as unreliable narrators, perhaps we wouldn’t need psychiatry. We would have the full truth of the psychological phenomena, which IS the problem, not the brain, and that psychological problem needs to be observed and understood in order to resolved, because observation of it is our only possible access to it. You can’t reach it through the brain or bloodstream. But naturally, if the brain is observing and resolving it’s own psychological phenomena, then it is changing and healing too, but no psychiatrist or drug is going to help the brain do this part. Only Mother Nature restores us to sanity, which really would mean love, connection and community for us, but we’ve destroyed that as well as Mother Earth. Hence the world goes mad and blames it on our brains.

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    • one of the best explanation I have seen on how to recover from trauma.
      Succent:

      “If all people suffering mental illness did the same, so long as we weren’t regarded as unreliable narrators, perhaps we wouldn’t need psychiatry. We would have the full truth of the psychological phenomena, which IS the problem, not the brain, and that psychological problem needs to be observed and understood in order to resolved, because observation of it is our only possible access to it. You can’t reach it through the brain or bloodstream.”
      Thank you

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