FDA panel rejects attempt to use psychedelic drug for PTSD treatment
PBS News Hour - Segments
PBS NewsHour
4.1 • 1K Ratings
🗓️ 4 June 2024
⏱️ 9 minutes
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| 0:00.0 | A key FDA advisory committee today rejected the use of a psychedelic drug to help patients |
| 0:06.8 | struggling with post-traumatic stress disorder, questioning the trials and its effectiveness. The FDA must now decide whether it will follow the had long our science correspondent, Miles O'Brien, |
| 0:24.0 | covered this day-long hearing |
| 0:26.0 | and he joins us now. |
| 0:27.0 | So Miles, why did the committee |
| 0:28.0 | rejected? |
| 0:29.0 | There'd been so much interest around this drug. |
| 0:31.0 | Jeff, it's a complicated one for the FDA because we're not talking just about a drug, we're |
| 0:37.4 | talking about a treatment regime that involves the drug, plus a very elaborate set of psychotherapy. |
| 0:44.2 | And the FDA, interestingly, does not regulate psychotherapy. |
| 0:49.1 | In addition, the psychotherapy, |
| 0:50.9 | which was part of this study was not standardized. The study also had a very fundamental problem which is to say it could not be properly blinded. Those who receive MDMA, ecstasy, |
| 1:04.0 | Not in a sugar pill, you know you didn't. |
| 1:08.0 | And so it was very difficult to get really objective results because the psychological factor of knowing that |
| 1:16.3 | you've had it favors a favorable outcome or a favorable response I should say. |
| 1:22.1 | And in addition to that, the company overlooked problems, |
| 1:26.4 | or so the committee determined, |
| 1:28.2 | overlooked problems in its pursuit of approval of this drug. |
| 1:32.8 | It really was a surprising decision, particularly given what we have heard over the years |
| 1:38.4 | from many of the subjects who have described this drug and this therapy as a life-changing experience. |
| 1:44.8 | C.J. Harden is a former Army helicopter mechanic and machine gunner who faced imminent death in Iraq and also after he got home. |
| 1:57.0 | I didn't trust myself having a weapon around me because I was suicidal, very suicidal at that point. |
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