FDA Panel Rejects MDMA-Assisted Therapy for PTSD: Rigorous Clinical Trials and Transparency Needed

Boston, Massachusetts United States of America
Concerns over flawed clinical trials and potential misconduct
FDA advisory committee voted against approval of MDMA-assisted therapy for PTSD
First time FDA considered a Schedule I psychedelic for medical use
PTSD patients continue to search for effective treatments while FDA investigates allegations
Setback may slow down expansion of psychedelics market
FDA Panel Rejects MDMA-Assisted Therapy for PTSD: Rigorous Clinical Trials and Transparency Needed

In a recent development, the Food and Drug Administration (FDA) advisory committee has voted against the approval of MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD), citing concerns over flawed clinical trials and potential misconduct. The decision comes as a disappointment to advocates who have long pushed for the inclusion of psychedelics in mental health treatments.

The FDA panel, which includes experts from various fields, voted 9-2 against the treatment's efficacy and 10-1 against its safety. This marks the first time that FDA advisers have considered a Schedule I psychedelic for medical use. If approved, it would have been the first new treatment for PTSD in over two decades.

The panel's concerns stem from shortcomings in the clinical research and allegations of misconduct and bias within the trials. Lykos Therapeutics, which sponsored the studies, could see their FDA approval jeopardized by this vote. The setback may also slow down the expansion of the psychedelics market.

The PTSD patients who have been suffering from debilitating symptoms such as intrusive memories and nightmares, anxiety, and suicidal thoughts will continue to search for effective treatments. The FDA is currently investigating these allegations and will make a final decision based on the available evidence.

Despite the setback, some experts remain optimistic about the potential of psychedelics in treating mental health disorders. Kim Witczak, a consumer representative on the FDA's advisory committee, believes that this is just one step in a long process and that more research is needed to fully understand the benefits and risks of these drugs.

The rejection of MDMA therapy for PTSD highlights the importance of rigorous clinical trials and transparency in scientific research. It also underscores the need for diverse sources of information to ensure a complete understanding of complex issues.


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Confidence

85%

Doubts
  • Are the allegations of misconduct substantiated?
  • Were all aspects of the clinical trials thoroughly investigated?

Sources

73%

The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
(Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

FDA advisors reject MDMA therapy for PTSD, amid concerns over research

National Public Radio (NPR) Will Stone Tuesday, 04 June 2024 00:00
  • Unique Points
    • Lykos Therapeutics could see their FDA approval jeopardized by the panel’s vote.
    • Shortcomings in the clinical research and concerns over potential misconduct and bias in the trials have raised doubts about MDMA’s efficacy and safety.
  • Accuracy
    • A panel of experts advising the FDA on the use of MDMA for PTSD found that the available evidence doesn’t show that the drug is effective or that its benefits outweigh its risks.
    • MDMA has the same abuse potential as a Schedule II stimulant, like cocaine, according to FDA’s review.
    • In one study, 67% of participants who received MDMA no longer met diagnostic criteria for PTSD after three dosing sessions, compared to 32% of those in the placebo group who underwent therapy sessions but did not receive an active drug.
    • The FDA is investigating allegations of misconduct and potential bias in the clinical trials.
  • Deception (30%)
    The article contains selective reporting as the author only reports on the negative findings of the FDA advisory panel and does not mention or provide context about the positive findings. The author also uses emotional manipulation by implying that this is a major setback for proponents of MDMA therapy and Lykos Therapeutics, which could influence readers' emotions towards the topic.
    • Following public comment and discussion, the panel voted 9-2 that MDMA – in combination with talk therapy – is not effective for treating PTSD. And they voted 10-1 that the benefits of MDMA treatment don’t outweigh its risks.
    • A panel of experts advising the Food and Drug Administration on the use of the psychedelic MDMA for post-traumatic stress disorder found on Tuesday that the available evidence doesn’t show that the drug is effective or that its benefits outweigh its risks.
    • It represents a major setback for proponents of the drug and Lykos Therapeutics, which sponsored clinical trials of the drug.
  • Fallacies (80%)
    The author makes several appeals to authority when reporting on the concerns and opinions of FDA staff and members of the advisory panel. He also uses inflammatory rhetoric when describing some of the allegations against the clinical trials. However, no formal or dichotomous fallacies were identified in this article.
    • ][FDA staff] focused on uncertainties and gaps in the data, unanswered questions about its potential for abuse and a lack of evidence supporting the psychological approach used in the therapy sessions.[/]
    • [[]Some on the panel have explicitly brought up allegations that have surfaced about possible misconduct and bias in the trials that could have skewed the results.[/
  • Bias (80%)
    The author does not explicitly demonstrate bias in the article. However, there are some instances where the author seems to lean towards expressing concerns about potential misconduct and bias in the clinical trials. This could be seen as a subtle form of bias against MDMA therapy for PTSD. The author also quotes several panelists who express similar concerns, which may reinforce this bias.
    • Some on the panel have explicitly brought up allegations that have surfaced about possible misconduct and bias in the trials that could have skewed the results.
      • The drug company has pushed back on the allegations and said it stands behind the data.
      • Site Conflicts Of Interest (100%)
        None Found At Time Of Publication
      • Author Conflicts Of Interest (100%)
        None Found At Time Of Publication

      77%

      The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
      (Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

      A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

      FDA advisers vote against first MDMA therapy to treat PTSD

      CNN News Site: In-Depth Reporting and Analysis with Some Financial Conflicts and Sensational Language Deidre McPhillips Tuesday, 04 June 2024 12:01
      • Unique Points
        • Two out of eleven committee members considered the treatment effective, while nine did not
        • One committee member believed benefits outweigh risks but ten voted against it
        • This was the first time FDA advisers considered a psychedelic drug for medical use
      • Accuracy
        • >5% of adults in US experience PTSD annually, with limited treatment options available
        • >25% of participants experienced rapid improvement in PTSD symptoms according to FDA data
      • Deception (30%)
        The article contains selective reporting as it only reports on the concerns raised by some committee members about the bias and missing information in the Lykos trials. It does not provide any context or counterarguments from other committee members who considered the treatment effective. The author also uses emotional manipulation by describing PTSD as a 'significant need' and current treatments as 'limited in their scope and effectiveness'.
        • Many of the FDA advisory committee members applauded the exploration of this line of treatment and lauded the potential it holds, but several shortcomings raised critical doubts.
        • The Institute for Clinical and Economic Review also cited 'substantial concerns about the validity of the results' in a report published in March.
        • The committee had concerns about the integrity of the particular trials up for review.
      • Fallacies (85%)
        The article contains several informal fallacies and a potential appeal to authority. The author uses emotive language and makes assumptions without providing evidence. She also quotes experts making statements that could be interpreted as an appeal to authority, but the context does not fully support this interpretation.
        • But the agency also noted that ‘several factors make these data challenging to interpret and complicate the benefit-risk assessment for this application,’ posing key questions for the members of the Psychopharmacologic Drugs Advisory Committee to consider.
        • ,,The Institute for Clinical and Economic Review, a nonprofit that conducts independent reviews of treatments, tests and procedures, also cited ‘substantial concerns about the validity of the results’ of the Lykos trials in a report published in March. Those concerns centered around bias.,
        • ,,Dr. Rachel Yehuda, director of the Center for Psychedelic Psychotherapy and Trauma Research at Mount Sinai’s Icahn School of Medicine, who is not a member of the FDA advisory committee, said ‘My fear would be that we stop being curious, we stop asking the right questions, we stop trying to figure out mechanisms of action, we stop trying to perfect and scale like we do with any other treatment.’
      • Bias (100%)
        None Found At Time Of Publication
      • Site Conflicts Of Interest (100%)
        None Found At Time Of Publication
      • Author Conflicts Of Interest (100%)
        None Found At Time Of Publication

      75%

      The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
      (Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

      A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

      FDA panel rejects first MDMA treatment amid deep concerns about flawed trials

      NBC News Digital Tuesday, 04 June 2024 23:15
      • Unique Points
        • FDA scientists raised concerns about how the trials were carried out and the adequacy of blinding
        • The FDA is investigating allegations of misconduct and potential bias in the clinical trials.
      • Accuracy
        • In both trials, researchers found that MDMA along with talk therapy reduced the severity of symptoms in nearly 86% of participants after 18 weeks
        • Lykos recommended that two therapists be present for therapy sessions; panel members wanted to ensure both therapists were licensed
      • Deception (30%)
        The article reports on the FDA's rejection of MDMA as a treatment for PTSD due to concerns about flawed trials. The author quotes several experts expressing their opinions on the data and study design. While this is not inherently deceptive, it does lean towards selective reporting by focusing solely on the negative aspects of the trials and ignoring any potential benefits or positive findings. Additionally, there are instances of emotional manipulation through phrases like 'major setback for advocates who have long pushed to include psychedelics in treating mental health disorders' and 'the need for new PTSD treatments against serious concerns about the data'. These phrases create a sense of urgency and importance around the issue, potentially swaying readers' opinions without providing all relevant information.
        • patients report, nothing gets done.
        • major setback for advocates who have long pushed to include psychedelics in treating mental health disorders
        • we expressed continued concern about the adequacy of blinding
      • Fallacies (85%)
        The article contains several instances of Appeals to Authority fallacies. The FDA scientists and the Institute for Clinical and Economic Review are cited as authorities expressing concerns about the trials, but their opinions do not necessarily mean that the concerns are valid or that there are actually fallacies in the data. Additionally, some panel members' reservations about the trials may also be considered Appeals to Authority if they are presented as definitive reasons for rejecting the approval of MDMA as a treatment for PTSD without providing any evidence or reasoning beyond their own authority.
        • ]The FDA scientists wrote that “as a result, studies are nearly impossible to blind.”[
        • The Institute for Clinical and Economic Review said patients and providers in the trial treated psychedelics “more like a religious movement than like pharmaceutical products.”[
        • Elizabeth Joniak-Grant wondered “how much that impacted the efficacy.”[
        • Kim Witczak wanted to ensure that both therapists were licensed, and that patient concerns would be addressed.[
      • Bias (90%)
        The article expresses a neutral tone towards the FDA's decision to reject the approval of MDMA as a treatment for PTSD. However, there are several statements that suggest a bias against Lykos Pharmaceuticals and their data. The author mentions 'serious concerns about the data' submitted by Lykos and quotes panel members expressing reservations about the trials, including issues with blinding, previous MDMA use by participants, and potential risks to patients at the hands of providers. These statements imply a negative view of Lykos Pharmaceuticals and their research. Additionally, there is a quote from an outside organization (Institute for Clinical and Economic Review) expressing concerns about the trials being treated 'more like a religious movement than like pharmaceutical products.' This statement also implies a negative view of the trials and could be seen as biased.
        • Indeed, panel members had reservations about the trials, including that many patients had used MDMA before and that some therapists may have encouraged favorable reports from patients.
          • Last week, the Institute for Clinical and Economic Review, a nonprofit group that evaluates the cost of drugs, said patients and providers in the trial treated psychedelics ‘more like a religious movement than like pharmaceutical products.’
            • The votes reflected panel members’ struggle to balance the need for new PTSD treatments against serious concerns about the data.
            • Site Conflicts Of Interest (100%)
              None Found At Time Of Publication
            • Author Conflicts Of Interest (0%)
              None Found At Time Of Publication

            81%

            The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
            (Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

            A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

            The psychedelic medicine revolution just took a big loss

            Politico News Site Name: POLITICO Full Legal Name of News Site: Politico LLC Location of News Site: Washington D.C., USA Tuesday, 04 June 2024 00:00
            • Unique Points
              • Veterans who have experienced traumatic events are at particular risk for PTSD, prompting the VA to investigate psychedelics as a treatment.
              • Lykos Therapeutics pointed to its trial data finding sixty-seven percent of participants with severe PTSD who received MDMA combined with therapy no longer met the diagnostic criteria for the disorder, compared with 32 percent in the group that received therapy and a placebo.
            • Accuracy
              • The federal agency that regulates drugs said Tuesday that ecstasy, when combined with therapy, is not an effective treatment for post-traumatic stress disorder and its use puts patients at risk of serious side effects.
            • Deception (50%)
              The article is deceptive in its omission of the fact that Lykos Therapeutics' MDMA therapy has shown positive results in clinical trials and has been designated as a breakthrough therapy by the FDA. The author also implies that the expert advisory committee unanimously voted against the treatment, when in fact, it was a 9-2 vote on effectiveness and 10-1 on risks outweighing benefits. This misrepresents the level of opposition to Lykos Therapeutics' MDMA therapy.
              • If the FDA follows its advisers, as it typically does, it could upend a burgeoning industry already banking on using a variety of mind-altering drugs to treat disorders ranging from depression to anxiety.
              • Veterans who've experienced traumatic events are at particular risk for PTSD, prompting the VA to investigate psychedelics as a treatment. | Ben Sklar/Getty Images
            • Fallacies (80%)
              The article contains an appeal to authority fallacy when it quotes Dr. Paul Holtzheimer stating that 'premature introduction of a treatment can actually stifle development and stifle innovation.' This statement is not a logical argument against the effectiveness or safety of MDMA as a PTSD treatment, but rather an opinion from one expert. Additionally, there are instances of inflammatory rhetoric used in the article when it refers to the 'burgeoning industry' and compares the hype for psychedelics as a cure for mental illness to 'belief in fairy tales.' These statements do not provide any logical reasoning or evidence against MDMA as a PTSD treatment.
              • ]An expert advisory committee voted 9-2 that Lykos Therapeutics’ combo regimen of talk therapy and MDMA, the technical name for the drug, is not an effective PTSD treatment and 10-1 that the therapy’s risks outweigh its benefits.[
              • But the advisers found that Lykos’ trials most likely suffered from expectation bias since patients were able to figure out they received the drug, rather than a placebo, and that might have made them more likely to say it was beneficial.
              • We have substantial concerns about the validity of the results.[
              • The institute also critiqued the psychedelic community, which it said treats psychedelic drugs ‘more like a religious movement than like pharmaceutical products.’
            • Bias (100%)
              None Found At Time Of Publication
            • Site Conflicts Of Interest (100%)
              None Found At Time Of Publication
            • Author Conflicts Of Interest (0%)
              None Found At Time Of Publication

            88%

            The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
            (Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

            A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

            Psychedelics Are Challenging the Scientific Gold Standard

            The Atlantic Magazine Jonathan Lambert Monday, 03 June 2024 19:35
            • Unique Points
              • Approval could bring relief to approximately 13 million Americans with PTSD and serve as a model for other psychedelics
              • High proportions of unblinding in positive psychedelic trials don’t necessarily mean results are invalid, but rather that context plays a role in treatment success
            • Accuracy
              • FDA is set to discuss whether to approve the first psychedelic drug for PTSD treatment
              • MDMA-assisted therapy showed promising results in clinical trials with PTSD patients
            • Deception (100%)
              None Found At Time Of Publication
            • Fallacies (85%)
              The article contains an appeal to authority fallacy when it states 'Many scientists want to get around this problem by designing better blinds.' and 'From this perspective, high proportions of unblinding in positive psychedelic trials don’t necessarily mean that the results are invalid.' The author is quoting the opinions of multiple experts in the field, but these opinions do not provide evidence for or against the validity of unblinded studies. Additionally, there is a use of inflammatory rhetoric when it states 'unblinding threatens to undermine the entire field of psychedelic research.' This statement is an overexaggeration and does not accurately reflect the potential impact of unblinding on psychedelic research.
              • ]Many scientists want to get around this problem by designing better blinds.[
              • From this perspective, high proportions of unblinding in positive psychedelic trials don’t necessarily mean that the results are invalid.
            • Bias (100%)
              None Found At Time Of Publication
            • Site Conflicts Of Interest (100%)
              None Found At Time Of Publication
            • Author Conflicts Of Interest (100%)
              None Found At Time Of Publication