Not looking good for FDA to approve MDMA-assisted therapy

Today was the big public hearing of the advisory panel whose recommendations will very likely be taken up by FDA.

Archive of the livestream which include lots of vets and other people giving firsthand accounts of having their lives saved.

quote:

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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.

Many of the committee members said they were especially worried about the failure of Lykos to collect detailed data from participants on the potential for abuse of a drug that generates feelings of bliss and well-being.

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LINK

Letting the perfect be the enemy of the good. Utterly preposterous that MDMA is a Schedule 1 substance. So very clearly safer and less destructive than alcohol in nearly every respect.