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    Psychedelic treatment for PTSD faces misconduct hurdle

    en-usJune 03, 2024

    Podcast Summary

    • Aging Insecurities and MDMAAs we age, some insecurities may fade, and MDMA, a chemical in ecstasy, could become an approved therapy for PTSD, but its FDA approval is controversial due to data concerns

      As we age, our insecurities may soften, allowing us to become less bothered and more indifferent to things that once troubled us (Jack Antonoff on Wild Card). Meanwhile, in the world of mental health, MDMA, the chemical found in ecstasy, is on the verge of FDA approval as a potential therapy for PTSD. However, controversy surrounds the data used to support this decision, which could impact the drug's path to market (Will Stone on Shortwave from NPR). Elsewhere, the historical significance of Birmingham, Alabama, extends beyond the civil rights movement to include its status as the oldest professional baseball park in America. The struggles for freedom experienced there are brought to life in Rickwood, a story shared by Roy Wood Jr. on Road to Rickwood from WNO and WRKF (NPR Network).

    • FDA decision on psychedelics researchThe FDA's upcoming decision on psychedelics research, specifically MDMA-assisted therapy, could bring significant advancements in mental health treatment if approved, as shown by promising phase three clinical trial results.

      The economy and current events can be confusing and overwhelming, but listening to podcasts like Planet Money and Embedded from NPR can help simplify complex news and provide deeper understanding. A notable upcoming decision by the FDA regarding psychedelics research serves as a test case for these drugs' potential in mental health treatment. MDMA-assisted therapy, which is further along in the regulatory process, involves a detailed protocol under the supervision of two therapists, with several dosing and follow-up sessions to ensure safety and effectiveness. Last year, results from a phase three clinical trial for MDMA-assisted therapy were published, showing promising results.

    • MDMA for PTSDMDMA shows promise as a transformative new treatment for PTSD, with 71% of participants in clinical trials no longer meeting diagnostic criteria, compared to 48% in the control group. However, it comes with risks such as nausea, anxiety, and heart palpitations.

      Recent clinical trials suggest MDMA, also known as ecstasy or molly, could be a transformative new treatment for PTSD. In one trial, 71% of participants who took MDMA no longer met the diagnostic criteria for PTSD, compared to 48% in the control group. Some people who have tried this treatment describe it as life-saving and even transformational. However, every medical treatment comes with risks, and MDMA assisted therapy is no exception. Adverse events include nausea, anxiety, and heart palpitations, but overall, the treatment was considered generally well-tolerated in the trials. Despite some documented suicidal ideation in both groups, there was no increase in adverse events related to suicidality in the MDMA group. While more long-term data is needed, these findings suggest MDMA could be a meaningful new treatment for PTSD, offering relief for many people who don't respond to other treatments.

    • MDMA clinical trials validityThe Institute for Clinical and Economic Review questioned the validity of MDMA clinical trials due to study design issues and inadequate symptom assessment methods, which could impact FDA approval

      The Institute for Clinical and Economic Review raised concerns about the validity of the results from the MDMA clinical trials due to issues with study design and methods. Specifically, participants were often able to tell if they received the active drug rather than a placebo, and the method used to assess PTSD symptoms may not have captured the overall worsening of conditions. These concerns could potentially hinder FDA approval of MDMA as a therapy. However, it's important to note that there are multiple aspects to this complex issue, and further investigation is needed to fully understand the implications of these criticisms.

    • MDMA-assisted therapy trials for PTSDAllegations of bias and inappropriate conduct from therapists and patients in MDMA-assisted therapy trials for PTSD treatment could impact the credibility of the trials and the future of the therapy

      The validity of MDMA-assisted therapy trials for PTSD treatment is under scrutiny due to potential bias from therapists and patients with strong prior beliefs, as well as allegations of inappropriate conduct and unreported negative experiences. The Multidisciplinary Association for Psychedelic Studies (MAPS) and its drug company incubatee, Lycos Therapeutics, are at the center of this controversy, as they sponsored the trials and are seeking FDA approval for the drug. The report brought up concerns of therapists and patients from the psychedelic community influencing the trial results, with some even having been featured in a New York Magazine podcast discussing inappropriate conduct and negative experiences. These allegations, if proven true, could significantly impact the credibility of the trials and the future of MDMA-assisted therapy for PTSD treatment.

    • MDMA-assisted therapy trials defenseBoth Maple Tree Health and Lycos Biotech defended their MDMA-assisted therapy clinical trials against allegations of bias and misrepresentation, emphasizing commitment to rigorous research and regulatory oversight, and maintaining transparency and safety.

      Both Maple Tree Health and Lycos Biotech have defended the results of their MDMA-assisted therapy clinical trials, rejecting allegations of bias and misrepresentation. Maple Tree Health has maintained its commitment to rigorous research, analysis, and regulatory oversight. Willa Hall, a clinical psychologist involved in the trials, attested to the professionalism and meticulousness of the researchers. Jennifer Mitchell, the lead author of the published findings, assured that there was no pressure to manipulate results. Despite the controversy surrounding the Institute's report, both parties emphasized the importance of ensuring safety and maintaining transparency in the therapeutic process. The FDA's involvement in the trials also provides additional oversight and access to data.

    • FDA review of MDMA-assisted therapy for PTSDThe FDA is reviewing Lycos' application for MDMA-assisted therapy for PTSD, but concerns about data quality and potential manipulation may delay the decision, impacting the psychedelic movement's progress towards new treatments for PTSD

      The Food and Drug Administration (FDA) is currently reviewing an application from Lycos for MDMA-assisted therapy for PTSD, but the quality of their data has been called into question. Tomorrow, a panel of advisors will discuss the data and there will be an opportunity for public comment. A group of psychedelic researchers from Johns Hopkins University, who petitioned for the public meeting, have raised concerns about potential data manipulation and overlooked adverse events. An anonymous former employee of Lycos has also made similar allegations. The FDA has fast-tracked the drug application and plans to make a decision by early August. This moment is significant for the psychedelic movement as there is a lot of investment in this treatment, and a potential delay could mean continued waiting for those living with PTSD seeking new treatments.

    • Immersive journalismImmersive journalism, as showcased by NPR's Embedded podcast, uses firsthand experiences and on-site reporting to provide personal and intimate accounts, leaving a lasting impact on listeners.

      Key takeaway from this episode of NPR's Shorewave is the power of immersive journalism in uncovering untold stories. Embedded, a podcast under the NPR umbrella, brings listeners personal and intimate accounts that leave you curious and wanting to know more. The use of firsthand experiences and on-site reporting adds depth and authenticity to the narratives. Whether it's the smell of smoke and dust or the feeling of being speechless, these stories leave a lasting impact. Embedded is NPR's dedicated platform for documentary journalism, providing listeners with eye-opening content and behind-the-scenes access. To support public media and get more from your favorite NPR podcasts, including Embedded, consider signing up for NPR Plus.

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