MDMA: BREAKING OR HEALING HEARTS FOR THOSE WITH PTSD?

In August of 2024, the FDA denied approval for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), with concerns over trial data integrity and ethical issues. The FDA's decision prevented what many believed would be the first psychedelic treatment to receive federal approval. MDMA, also known as "ecstasy,"creates feelings of emotional warmth (that “love” feeling) and brings about sensory experiences. Such an experience may reduce fear responses. This effect, researchers hypothesize could help patients process and potentially overcome traumatic memories
in these therapy sessions.

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The rejection came to be after discovering potentially harmful information about research practices. Psychopharmacology's scientific journal took back a key Phase 2 study in early 2024, citing "protocol violations amounting to unethical conduct" at one research site. The editors also explained undisclosed conflicts of interest: "Several of the authors are affiliated with either the Multidisciplinary Association for Psychedelic Studies (MAPS) or MAPS Public Benefit Corporation (MAPS PBC), a subsidiary that is wholly owned by MAPS." This brings up the concern that those running the trials may have other motives than solely research, such as financial gain or work affiliation bias.

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Johns Hopkins researcher Nese Devenot PhD, was among the critics questioning the trials. In her FDA testimony, Devenot argued that MAPS/Lykos "exploited the suggestibility-enhancing properties of MDMA to advance an evangelical mission." She demonstrated instances where the risk of targeting and taking advantage of vulnerable populations allegedly led to boundary violations. One instance included a case where a therapist "engaged in a sexual relationship with the participant." Her concerns contributed to an FDA advisory panel voting 9-2 against recommending approval in June 2024.

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While some participants reported life-changing benefits, many questions remain about the study design. Critics also pointed to issues with placebo controls and adjunct therapies- additional treatments given with the primary, such as cognitive behavioral sessions combined with medication administration. Patients could easily determine whether they received MDMA or a placebo based on the drug's distinctive effects, potentially biasing results. Neurologists have also raised concerns about potential neurotoxicity, noting MDMA's documented effects on brain neurotransmitters, which may cause long-term damage the brain.
 

This case overall demonstrates the tensions between the desperate need for effective PTSD treatments and maintaining scientific integrity. As Robert Whitaker notes in "Modern-Day Alchemy," pharmaceutical companies have historically participated in "a deliberate multi-pronged campaign to create a favorable public opinion" of their products, sometimes at the expense of safety (Whitaker 156). Following the FDA's decision, Lykos Therapeutics underwent a major restructuring, reducing its workforce by 75%. The company remains strong-willed to pursue approval, stating they'll "work tirelessly and use all available regulatory pathways" to advance this controversial treatment.
 

Works Cited

Lykos Therapeutics. "Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD." News.lykospbc.com, 9 Aug. 2024.

Springer. "Retraction Note to: 3,4-methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: a randomized phase 2 controlled trial." Psychopharmacology, 2024.

Mitchell, Jennifer, et al. "MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study." Nature Medicine, vol. 27, 2021, pp. 1025-1033.
Whitaker, Robert. "Modern-Day Alchemy." Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill. Basic Books, 2010, pp. 141-167.

Alexander, Natalie L. "Comment on FDA-2024-N-1938-0043." Regulations.gov, 2024. Devenot, Nese. "MAPS is an MDMA therapy cult." Chemical Poetics, June 2024.
Mustafa, N.S., et al. "MDMA and the Brain: A Short Review on the Role of Neurotransmitters in Neurotoxicity." Basic Clinical Neuroscience, vol. 11, no. 4, 2020,
pp. 381-388.
The New York Times. "FDA Denies Approval for MDMA Psychedelic Therapy." The New York Times, 4 Feb. 2025.