Friday, July 19, 2024

MAPS: FDA votes on psychedelic therapy

(Science Friday) Last month, the first psychedelic therapy treatment came before the FDA (Food and Drug Administration) for a vote. It entailed using MDMA, also known as ecstasy, E, or molly, to treat PTSD (post-traumatic stress disorder).

MDMA therapy has looked promising as a treatment for PTSD and other mental health conditions in some studies.
  • [It was thought by many in MAPS or the Multidisciplinary Association for Psychedelic Studies) to be a slam dunk for the first approval before moving on to passing magic mushrooms, DMT, and other scientifically-validated entheogens.]
But the FDA scientific advisory panel that evaluated this treatment voted overwhelmingly against approving it.
  • [For one thing, how would Big Pharma make so much money on endless "treatments" if someone comes up with an actual "cure" for a serious ailment?]
Many of the arguments against approval had less to do with MDMA itself than with the methodology of the clinical trials done by Lykos Therapeutics, formerly the Multidisciplinary Association for Psychedelic Studies (MAPS).

The FDA panel was presented with allegations of misconduct and incongruous data, including a letter by trial participant Sarah McNamee.

McNamee, who joined the trial for treatment of PTSD, is also a licensed psychotherapist and researcher of trauma and psychotherapy at McGill University in Montreal.

She joins Science Friday guest host Rachel Feltman alongside Dr. Eiko Fried, a methodologist and psychologist at Leiden University in the Netherlands, to discuss the decision.

If anyone is struggling with PTSD or other mental health conditions, call 988 for the suicide and crisis lifeline.
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