Psychedelic Research Proves Rather Tricky for the FDA

Nasty claims of bias and impartial research stand in the way of MDMA gaining FDA clearance for PTSD.
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As it turns out, researching the efficacy of MDMA to treat PTSD may be pretty complicated. The initial efforts to secure governmental sanction for a psychedelic substance for mental health care, in this case, MDMA, are facing some serious scrutiny over the clinical trial process, the Washington Post reports

MDMA has long been lauded as a treatment for PTSD, which affects 6% of the U.S. population. Per a Multidisciplinary Association for Psychedelic Substances (MAPS) 2023 study on how the drug can treat PTSD, the researchers found that, as High Times reported, in the MDMA group, 86% showed improvement in their standard PTSD assessment. 69% of those in the placebo group also improved. A standard PTSD assessment evaluates the intensity of PTSD symptoms, which can include anxiety, phobias, insomnia, and emotional numbness, among others. When the study wrapped, 72% of people within the MDMA treatment group no longer matched the criteria for PTSD, compared to 48% of the placebo participants.

Given how awful PTSD can be and, to be honest, how fun (and effective) MDMA can be compared to other treatment methods, this research was generally met with enthusiasm. While SSRI antidepressants like Zoloft are FDA-approved to treat PTSD, research shows it’s not always effective. The study in question shows that it had a response rate of 60%, which is obviously lower than the 86% improvement rate that came with MDMA.

However, per an independent analysis into the reliability of patient studies that are backing the Food and Drug Administration (FDA) application for MDMA, apparently, it’s pretty tricky to discern how effective these results are. Compared to other treatments, there are some serious hurdles associated with studying and then implementing psychoactive substances such as MDMA. 

While the bliss that MDMA can bring is generally considered a plus, it may make it trickier to study. One of the biggest challenges that arose when looking at the MDMA trial is that participants in the placebo group, who received a fake version of MDMA, could tell they hadn’t received the real thing because they experienced no changes in perception or euphoria, so it was rather obvious that they were in the placebo group, as noted in a draft report by the nonprofit Institute for Clinical and Economic Review (ICER). This lack of “blinding” in the trial, crucial for assessing the drug’s impact, potentially compromises the validity of the results.

The second hiccup when studying MDMA for PTSD came from the possibility that therapists were skewing the results. They basically thought that the therapists who were a part of the trial, there for mental health support, were biased in favor of MDMA, perhaps along with the participants, many of whom had previous positive experiences with the drug and, as a result, couldn’t provide the neutral ground required for a reliable study. 

The report also highlighted worries that participants who received MDMA felt “pressured to report good outcomes and suppress bad outcomes,” per the Washington Post. It also pointed to a documented instance of therapist misconduct that heightened safety concerns. While MDMA can be used to treat PTSD for sexual assault survivors, the psychedelic community may have some damage control of their own that needs a reckoning. Apparently, the ICER staff talked to folks who were part of a New York Magazine podcast investigating the MAPS’s clinical trial, in particular, patients who said they were victimized by therapists or coerced into reporting beneficial outcomes. According to one account, a woman in a MAPS trial states she was abused by her assigned therapists. 

ICER staffers, after speaking with several former patients and individuals associated with MAPS trials, observed that some adverse effects mentioned in the trial were not captured in the data they reviewed. While MDMA could help relieve horrid symptoms of PTSD, which include self-harm and thoughts of suicide, both of those were also included in the side effects (for both the MDMA group and those who got a placebo). People who have taken MDMA recreationally sometimes speak of “suicide Tuesday,” aka the crash after enjoying the spike of the drug on the weekend, and not only does this appear to roar its head within the trials, but those who spoke on the subject voiced concerns that there may be underreporting of such negative side effects. 

While some of this seems shocking when laid out in print, remember that none of the adverse claims or concerns are news to those in the psychedelic community. There is no medicine that exists without side effects; the silver bullet is a myth. If one finds healing through psychedelics, enjoy it while understanding the well-established risks (and benefits) that come with such a medicine. 

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