FDA's Controversial Decision on MDMA for PTSD Treatment

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Transcript

Yesterday, the FDA Advisory Committee voted against approving MDMA, aka Ecstasy or Molly, for treating PTSD when combined with psychotherapy. Even though the two clinical trials they submitted as evidence show that it worked really well, with around 80% showing a large reduction in symptoms, and three quarters of those getting to the point where they no longer even qualified as being diagnosed with PTSD, after having severe PTSD for around 15 years. I'll show you a clip from one of the participants that really moved me. around 13 million people in the US alone suffering from PTSD. Close to 2,000 suicides per year attributed to it, and it costs the U.S. economy over $200 billion per year. And it's been 25 years since the FDA approved any new treatment for it. So why did the FDA say no here? The meeting lasted 8 hours. They brought in over 30 speakers. Some were scientists who have been studying MDMA for years and others were clinical trial participants that were in the trials that were submitted. They told personal stories both amazing and horrifying. votes. First, is MDMA effective for treating PTSD? They voted 9 to 2 in favor of it not being effective. Second, do the risks outweigh the benefits? And here they voted 10 to 1 in favor of, nope, it's too risky. But why? There are many reasons and I have mixed feelings about them. For effectiveness, the biggest concern was, surprise, surprise, it's really hard to have a good placebo for a drug like this. When you take it, you know. They measured PTSD severity on an 80-point scale, where higher scores mean more severe symptoms. The studies did three sessions over 18 weeks where they either did psychotherapy plus a placebo or psychotherapy plus MDMA. By the end of the studies, the therapy group improved by around 14 points. Still pretty good. But the therapy plus MDMA group improved by 24 points, and it lasted at least six months out. But we don't know how much of this effect was just because they felt something from the MDMA, and they believed that it would help them, as opposed to it being some real chemical effect that really works for PTSD. The placebo is strong. There were also concerns about insufficient safety data its effect on the heart and liver, a high dropout rate for the studies, around one and four by month six, lack of study diversity, lots of white people, lack of reporting about the pleasurable experiences of the MDMA and thus its potential for abuse, and one case of improper physical touching by the therapists, one of whom was unlicensed. Yikes. What makes this whole process harder is that the FDA has never had to regulate a combination drug plus talk therapy before. You don't want to just give the former, but it's really hard to standardize the latter. But there is still hope. First, this is just the advisory committee and the FDA will make its final decision in August where it could go against the committee's recommendation, but probably won't. But I've been following this space for a long time, and I do believe that we will eventually see MDMA approved for clinical use with careful oversight in treatment-resistant PTSD. The committee's vote here was less that it doesn't work, and more that this particular company, called Lycos, did not do a good enough job with their study design and their overall submission. lot by human behavior and skill of the clinician. More scientific rigor is needed to quantify and standardize everything so that it's as safe and effective as possible before being released out into the wild. But I for one hope that this does happen as soon as possible because a treatment like this has the potential to drastically improve millions of lives. And now here's a clip from Christina Pierce, one of the clinical trial participants who told her story at the FDA meeting. I hope in the future we'll see many more stories like this. MDMA assisted therapy saved my life. I was five when first sexually assaulted by a family friend. I noticed symptoms once problematic. Over the next 40 years, I was diagnosed with depression, anxiety, and bipolar disorder. Doctors prescribed many, many medications, and I felt like a lab rat. One antidepressant energized me to attempt suicide. After that, I was nervous about taking any drugs. I managed my disease with disciplined, exercise, and diet. I had some successes in life that suffered from failed marriages. I felt numb. I trusted no one, and I self-medicated with alcohol. I increasingly felt suicidal. Finally, when I was 45, I was diagnosed with PTSD, yet doctors offered me the same meds. I kept searching for new treatments and found this trial. session, I felt an intense sense of repair, a spontaneous rewiring of my mind to body. The effects were immediate. The emotional flooding vanished. What used to feel like a tsunami of overwhelming panic was now merely a puddle at my feet. A changed perspective is everything. If MDMA is a reset button, my skilled therapists were right there to ground my experience. Our therapeutic alliance fully unlocked this window of opportunity to process my traumas. It was hard work, but the results were life-changing. None of my previous therapies came close to unraveling all of my trauma. The best aspect of this medicine is that I no longer need it. My MDMA training wheels are off and I no longer need any medication and especially not alcohol. PTSD is no longer my life sentence. Now, I'm in grad school studying clinical mental health counseling. I also founded Proteo Foundation, a public charity supporting women's trauma recovery, because every 68 seconds, an American is sexually assaulted. Every nine minutes that victim is a child, and 91% of victims are female. Mind was never reported. Many victims never connect the dots to PTSD. Each day we postpone this therapy, I ask, at what cost, how many more people need to die before we approve an effective therapy? As you weigh the risks, please keep in mind the death rate for this understated population. for perspective. This therapy can save many lives. I lost most of my life to this disease. I am grateful to reclaim it now, but I wish this was an approved medication decades ago.

Additional notes

In a surprising decision, the FDA advisory committee recently voted against the approval of MDMA, commonly known as ecstasy or molly, for treating PTSD in combination with psychotherapy. Despite evidence from clinical trials showing significant improvement in approximately 80% of participants, the committee raised concerns about the drug’s effectiveness and safety. Comment below with your thoughts on MDMA’s potential or share your experiences with PTSD treatments. Watch Cristina Pearse’s moving testimony from the clinical trial at the FDA meeting. Subscribe for more updates on groundbreaking treatments and health/sciece news. 📚Sources: nature.com/articles/s41591-023-02565-4 nature.com/articles/s41591-021-01336-3 icer.org/wp-content/uploads/2024/03/PTSD_Draft-Report_For-Publication_03262024.pdf fda.gov/media/178984/download BE MY FRIEND: 💌 Sign up to my weekly email newsletter - https://distilledscience.xyz/newsletter WHO AM I: I’m Avisha, a scientist living in NYC. I consult with companies and VC firms helping them understand new technologies and make the best decisions regarding them. I’ve been making short-form videos on TikTok and Instagram for the last 2.5 years, and am now venturing out into longer form content, both on YouTube and my blog! I also write a “getting-closer-to-weekly” newsletter that contains some quick thoughts and useful links to interesting things (https://distilledscience.xyz/newsletter)

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