FDA Rejects MDMA for Mental Health Treatment After Identifying Flawed Study Data

LOS ANGELES - Amzeal -- The Citizens Commission on Human Rights International welcomed the Food and Drug Administration's (FDA) recent decision to disapprove the use of the hallucinogenic drug, MDMA (Ecstasy) as a treatment for Post-Traumatic Stress Disorder (PTSD). On August 9, the FDA rejected an MDMA application due to flawed clinical trial data, prioritizing patient safety over the manufacturer's interests—an investment of over $150 million in psychedelic research and advocacy since 2014.[1] The burgeoning psychedelic research market was hopeful for the MDMA approval which would have paved the way for other hallucinogenic drugs to enter mainstream psychiatric practice. However, CCHR warns that adding psychedelic drugs to an already saturated biomedical-based mental health system would only make it worse.

In June, the FDA's Psychopharmaceutical Advisory Committee scrutinized faulty research methods and potential risks of the drug, including heart problems, injury, and abuse. It advised the FDA to disapprove the application. The FDA agreed that the MDMA application had "significant limitations" that "prevent the agency from concluding that the drug is safe and effective."[2]

An editor of Psychiatric Times had asserted, "The rigorous, scientific, and comprehensive clinical development leading to this application stands as an exemplary model for how research in medication-assisted psychotherapy should proceed." The evidence does not support that.

In April, a group of more than 70 clinicians, investigators and others involved in the Phase 3 MDMA trials said that certain aspects of the trials were "misrepresented" and that a number of assertions amounted to "hearsay."[3] FDA staff noted: "We are particularly concerned that serious harm could result" and "may include, but are not limited to, events resulting in hospitalization or death…."[4] Following the FDA decision, the journal Psychopharmacology retracted three research papers it published on MDMA-assisted psychotherapy, citing "protocol violations amounting to unethical conduct."

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Shortly after, the journal editor who praised the MDMA research standard wrote that after many years of psychopharmacology consultations, a common question he still gets is "I've tried everything I can think of, but I can't get my patient any better.'" [Emphasis added]

CCHR says this failure should never be grounds to justify the approval of psychedelics, which had their day in the 1950s-1970s with disastrous results.

At an American Psychiatric Association seminar on psychedelics earlier this year, a prominent psychiatrist reminded the audience that psychedelics have been used in very unethical ways; for example, for CIA LSD mind control experiments of the 1950s. Journalist Stephen Kinzer, who spent several years investigating the experiments, stated: "We don't know how many people died, but a number did, and many lives were permanently destroyed."[5]

Tens of thousands of troops were used in testing conducted by the U.S. military between 1922 and 1975. Surviving veterans are suing.[6]

Also raised in the APA seminar was the gruesome Charles Manson murders of actress Sharon Tate and four others in 1969, committed under the influence of LSD.

One U.S. attorney tracking psychedelic research says, "Psychedelics are not a paradigm shift in psychiatry seeking workable treatment. They are nothing but the latest, and most hopeless dead end of all, in a ridiculous dark quest to turn people into nothing more than a brain to be controlled with drugs."

A 1967 conference predicting Psychotropic Drugs in the Year 2000, aimed to take advantage of the pharmaceutical industry's search for "chemical substances which would have mind-altering properties" for "the control of selective aspects of man's life." They were not shy about the intention behind this: "Those of us who work in this field see a developing potential for nearly a total control of human emotional status, mental functioning, and will to act. These human phenomena can be started, stopped, or eliminated by the use of various types of chemical substances" and "will affect the entire society."

More than 50 years later, the World Health Organization (WHO) stressed the need to "transition away from a narrow emphasis on biomedical approaches."[7] Former United Nations Special Rapporteur Dainius Pūras, M.D., also stated, "There is now unequivocal evidence of the failures of a system that relies too heavily on the biomedical model of mental health services, including the front-line and excessive use of psychotropic medicines, and yet these models persist."[8]

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Psychedelics are a lucrative market. More than 50 psychedelic companies have gone public in the U.S., currently have a combined valuation of more than $2 billion, and are hoping to reach $12 billion by 2030.

CCHR stresses the need for a thorough review of the risks and deaths associated with all psychotropic drugs, but especially psychedelics. It calls for a decisive move away from mind-altering chemicals and the biomedical approach, advocating for a focus on patient safety. The FDA's rejection of MDMA marks an important step in rethinking the ethical considerations of introducing dangerous drugs into mainstream use.

CCHR was established in 1969 by the Church of Scientology and Dr. Thomas Szasz, a professor of psychiatry and has helped achieve hundreds of laws to provide informed consent and other rights to mental health patients.

Sources:

[1] Andrew Jacobs and Christina Jewett "F.D.A.'s Review of MDMA Cites Health Risks and Study Flaws," New York Times, 1 May 2024; www.nbcnews.com/health/health-news/fda-rejects-psychedelic-mdma-assisted-therapy-ptsd-rcna165531

[2] time.com/7009737/fda-rejects-mdma-ptsd/

[3] "Exclusive: Therapists and Trialists from Lykos' Phase 3 MDMA-Assisted Therapy Studies Push Back on ICER's Critical Draft Report," Psychedelic Alpha, 29 Apr. 2024

[4] www.cchrint.org/2024/06/14/fda-panel-overwhelmingly-rejects-mdma-psychedelic-as-mental-health-treatment/; www.msn.com/en-us/health/other/fda-staff-raises-concerns-about-ecstasy-drug-s-safety-in-report/ar-BB1nozAn

[5] Terry Gross, "The CIA's Secret Quest For Mind Control: Torture, LSD And A 'Poisoner In Chief," NPR, 9 Sept. 2019, www.npr.org/2019/09/09/758989641/the-cias-secret-quest-for-mind-control-torture-lsd-and-a-poisoner-in-chie,

[6] www.npr.org/2015/09/05/437555125/veterans-used-in-secret-experiments-sue-military-for-answers

[7] www.cchrint.org/2023/09/18/who-guideline-condemns-coercive-psychiatric-practices/

[8] www.cchrint.org/2021/03/08/resource-on-why-psychiatry-is-upset-about-its-failures-and-critics/, citing: "World needs 'revolution' in mental health care – UN rights expert," 2017, www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=21689&LangID=E#sthash.MMIxDbIx.dpuf; A/HRC/35/21; "Promotion and protection of all human rights, civil, political, economic, social and cultural rights, including the right to development," Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Human Rights Council Thirty-fifth session, Agenda item 3, 6-23 June 2017