(4 Jun 2024)
RESTRICTION SUMMARY:
ASSOCIATED PRESS
Atlanta – 4 June 2024
1. SOUNDBITE (English) Barbara Rothbaum, Director of the Emory Healthcare Veterans Program:
"MDMA is not Ecstasy or Molly, but that is what people are taking when they take that, but that’s what you get on the street. And so you don’t really know what’s in it. All of these studies are using, like I tell my kids, pharmaceutical grade MDMA, you know exactly what’s in it. And it’s a drug with a lot of different actions. It’s an amphetamine, so it it jazzes people up. But it’s got a lot of other actions that we think and have been shown to help people be more open to experiences, to help people be able to approach memories that are stressful and make them anxious and distress and without as much distress. And that’s really where we think it’s it could be helpful for PTSD."
++BLACK FRAMES++
2. SOUNDBITE (English) Barbara Rothbaum, Director of the Emory Healthcare Veterans Program:
"Any new medication has to receive FDA approval. So they’ve been going through this process for a while, and now there’s a hearing where they’re going through some of the data."
++BLACK FRAMES++
3. SOUNDBITE (English) Barbara Rothbaum, Director of the Emory Healthcare Veterans Program:
"It’s not just MDMA. They’re looking for the approval of MDMA assisted psychotherapy. No one is saying just MDMA is going to help your PTSD. It’s MDMA assisted psychotherapy. And in their studies, all of the participants got a lot of psychotherapy."
++BLACK FRAMES++
4. SOUNDBITE (English) Barbara Rothbaum, Director of the Emory Healthcare Veterans Program:
"We absolutely need more treatment options. And PTSD sucks. It’s a lousy disorder to have. The way I see PTSD is people are haunted by something that happened to them in the past. It’s also a disorder of avoidance. So that means that they they don’t want to think about it. They don’t want to talk about it. They don’t want anything to remind them of it. But what that does is it just keeps it festering. So they’re not able to emotionally process it. MDMA and this class of medications are totally different from our typical psychiatric medications. Our existing psychiatric medications are meant to suppress symptoms. MDMA and the psychedelics are meant to help emotionally process material. So this is why I think it might be helpful for PTSD."
++ENDS ON SOUNDBITE++
STORYLINE:
A first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD was roundly criticized Tuesday — a potentially major setback to psychedelic advocates who hope to win a landmark federal approval and bring the banned drugs into the medical mainstream.
A panel of advisers to the Food and Drug Administration voted 10-1 against the overall benefits of MDMA when used to treat post-traumatic stress disorder. They cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse.
The FDA is not required to follow the group’s advice and is expected to make its final decision by August, but the negative opinion could strengthen FDA’s rationale for rejecting the treatment.
MDMA is the first in a series of psychedelics — including LSD and psilocybin — that are expected to come before the FDA for review in the next few years as part of a resurgence of interest into the drugs’ medical potential, which advocates claim could transform the treatment of mental health disorders.
Lykos and MAPS did not immediately respond to requests for comment Tuesday evening.
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