4.8 • 440 Ratings
🗓️ 17 June 2024
⏱️ 27 minutes
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0:00.0 | Did boundary violations sync MDMA assisted therapy, or was there something more? |
0:06.5 | In part two of our series, we look at what else went wrong. |
0:13.6 | Welcome to the Carlet Psychiatry Podcast, keeping psychiatry honest since 2003. |
0:19.2 | I'm Chris Akin, the editor-in-chief of the Carlisat Psychiatry Report. |
0:22.6 | And I'm Kelly Newsom, a psych-n-p, and a dedicated reader of every issue. |
0:30.6 | First, an apology. |
0:32.6 | We announced in the paper journal that we'd feature an interview with Kyle Greenway on |
0:36.6 | Catamine-assisted |
0:37.8 | therapy last week in our June 10th podcast. That has been moved to June 24 to make room for the |
0:44.9 | breaking news on MDMA. This month, an FDA panel voted to reject MDMA-assisted psychotherapy |
0:53.4 | for PTSD. That doesn't mean the case is closed. |
0:57.8 | The panel is an independent group of 11 scientists, clinicians and patient advocates who advised the |
1:03.2 | FDA. The FDA will make their final decision in August, and while there's still a chance for |
1:08.6 | approval, we're not optimistic. 90% of the panel members voted against it, and while there's still a chance for approval, we're not optimistic. |
1:16.1 | 90% of the panel members voted against it, and the agency usually follows their advice. |
1:22.3 | Sexual boundary violations, which we covered last week, were one of the reasons for the fail. Last year, we warned about this potential in a special issue on psychedelics, |
1:27.5 | but we didn't anticipate it would happen under the registered eye of the clinical trial. |
1:32.6 | But that was not the only problem that sank MDMA. |
1:36.0 | Another was functional unblinding, |
1:38.2 | which means that even though this was set up as a double-blind trial, |
1:41.5 | patients and the therapist could usually tell who got the placebo. |
1:52.9 | Imagine that you sign up for an MDMA trial, and the investigator tells you that you're going to get either MDMA or placebo. |
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