CCHR welcomes the FDA’s decision to disapprove the hallucinogenic drug, MDMA (Ecstasy) saying if approved, it would have fueled a planned $12 billion industry to add more mind-altering drugs to a failed biomedical-based mental health system.

By CCHR International
The Mental Health Industry Watchdog
August 16, 2024

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 drugmaker Lykos Therapeutics’ MDMA application due to flawed clinical trial data, prioritizing patient safety over the company’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 Lykos’ 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 erroneously 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.”[3] The evidence did 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.”[4] 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….”[5]

Shortly after the FDA decision, the journal Psychopharmacology retracted three research papers it published on MDMA-assisted psychotherapy, citing “protocol violations amounting to unethical conduct.” Psychedelics kingpin Rick Doblin and the Lykos Therapeutics CEO are among the authors of the retracted papers. As reported by STAT News, “Many authors on the three studies are affiliated with the Multidisciplinary Association for Psychedelic Studies (MAPS)” and its commercial spinout Lykos Therapeutics, including founder Rick Doblin, “who spearheaded the decades-long efforts to win approval for the psychedelic treatment. Lykos CEO Amy Emerson is an author as well.”[6]

The same psychiatrist and journal editor who praised the MDMA research standard recently 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.’”[7] [Emphasis added]

Had the FDA ruled in its favor, Lykos had the potential to become a multibillion-dollar company.[8] 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.[9] Journalist Stephen Kinzer, who spent several years investigating the CIA mind control research, stated: “We don’t know how many people died, but a number did, and many lives were permanently destroyed.”[10]

Tens of thousands of troops were used in testing conducted by the U.S. military between 1922 and 1975. Surviving veterans are suing.[11]

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.[12]

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 thepharmaceutical industry’s search for “chemical substances which would have mind-altering properties” for “the control of selective aspects of man’s life.”[13] 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.”[14]

More than 50 years later, the World Health Organization (WHO) stressed the need to “transition away from a narrow emphasis on biomedical approaches.”[15] Former United Nations Special Rapporteur Dainius Pūras, M.D., 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.”[16]

Psychedelics are a lucrative market. More than 50 psychedelic companies have gone public in the U.S. and currently have a combined valuation of more than $2 billion, and are hoping to reach $12 billion by 2030. In January 2024—likely in anticipation of a positive FDA decision regarding MDMA—there were five investment deals done trying to “harness mind-altering substances,” including MDMA, raising a whopping $163 million to invest in the market in one month alone.[17] 

The FDA decision is a setback for them, but CCHR says it is a win for patients’ rights and mental health given the history of psychotropic drugs marketed as “miracle” breakthroughs, only to be wrought with harmful side effects. In the 1950s, the “chemical lobotomy” Thorazine (chlorpromazine), an antipsychotic, came on the market. An estimated 100,000 Americans died because of the toxic side effect of antipsychotics, called neuroleptic malignant syndrome.[18] At least 15,000 die in nursing homes from antipsychotics, charged former FDA drug reviewer David Graham in congressional testimony.[19] In the late 1980s, SSRI antidepressants were to revolutionize mental health but faded fast as their suicidal and violent side effects emerged and are now linked to acts of senseless violence, such as mass shootings. Sexual dysfunction and debilitating withdrawal effects are now widely recognized.[20]

CCHR points to a sample of 15 school shooters between 2001 and 2019 alone that had been prescribed antidepressants or drugs for “depression,” with a death toll of over 25, and nearly 70 wounded.[21]

The FDA has told Lykos it can submit another Phase 3 drug trial, but CCHR said there needs to be a full analysis of the risks and deaths from all psychotropic drugs and a move away from mind-altering chemicals.

On the heels of the FDA decision and study retractions, Lykos announced it will lay off about 75% of its employees. Rick Doblin, Ph.D., the founder and president of MAPS, the parent company of Lykos, is also leaving his position on the Lykos board. [22] The company said it is bringing in psychiatrist David Hough to lead and oversee the clinical development of the MDMA capsules. Hough spent 17 years at Janssen Research and Development, LLC (a Johnson & Johnson company), where he was the leader of the SPRAVATO® (esketamine) compound development team.[23]

Esketamine has potentially serious risks because of its molecular similarity to ketamine, a “club” and “date rape” drug that can cause disassociation, meaning victims enter a state in which they feel as if their mind and body aren’t connected. The drug comes with a prominent warning: “Patients are at risk for dissociative or perceptual changes after administration” and it has the potential, like ketamine, to be abused. Janssen has paid $2.2 billion in criminal and civil fines to the Department of Justice over questionable marketing and selling of its antipsychotic, risperidone, and other drugs off-label (not FDA-approved).[24]

While the FDA is allowing Lykos the opportunity to submit another Phase 3 trial for MDMA, CCHR stresses the need for a thorough review of the risks and deaths associated with all psychotropic drugs. 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.

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[1] https://kffhealthnews.org/news/article/psychoactive-drugs-popularity-fda-regulation-studies-mdma/; https://psychedelicalpha.com/news/maps-pbc-closes-100m-series-a-rebrands-to-lykos-therapeutics; Andrew Jacobs and Christina Jewett “F.D.A.’s Review of MDMA Cites Health Risks and Study Flaws,” The New York Times, 1 May 2024; https://www.nbcnews.com/health/health-news/fda-rejects-psychedelic-mdma-assisted-therapy-ptsd-rcna165531

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

[3] John J. Miller, MD, “A Curious Juxtaposition, Psychiatric Times, 10 June 2024, https://www.psychiatrictimes.com/view/a-curious-juxtaposition

[4] “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, https://psychedelicalpha.com/news/exclusive-therapists-and-trialists-from-lykos-phase-3-mdma-assisted-therapy-studies-push-back-on-icers-critical-draft-report

[5] https://www.cchrint.org/2024/06/14/fda-panel-overwhelmingly-rejects-mdma-psychedelic-as-mental-health-treatment/; Fiona Rutherford and Robert Langreth, “FDA Staff Raises Concerns About Ecstasy Drug’s Safety in Report,” MSN.com, https://www.msn.com/en-us/health/other/fda-staff-raises-concerns-about-ecstasy-drug-s-safety-in-report/ar-BB1nozAn

[6] Meghana Keshavan, “Three MDMA therapy papers retracted over data integrity concerns,” STAT News, 11 Aug. 2024, https://www.statnews.com/2024/08/11/mdma-ptsd-lykos-maps-retractions/

[7] John J. Miller, “We’ve Only Just Begun…,” Psychiatric Times, 8 Aug. 2024

[8] “The drugmaker that hopes to legalize MDMA is cutting 75% of its staff after the FDA rejected the drug,” Business Insider, August 2024, https://www.msn.com/en-us/health/other/the-drugmaker-that-hopes-to-legalize-mdma-is-cutting-75-of-its-staff-after-the-fda-rejected-the-drug/ar-AA1oT3ys

[9] https://www.cchrint.org/2023/12/11/1950s-mk-ultra-mind-control-experiments-prompt-warning-about-psychedelic-research-today/, Brianna Nofil, “The CIA’s Appalling Human Experiments With Mind Control,” History Channel, https://www.history.com/mkultra-operation-midnight-climax-cia-lsd-experiments; Tom O’Neill, Dan Piepenbring, “Inside the Archive of an LSD Researcher With Ties to the CIA’s MK-Ultra Mind Control Project,” The Intercept, 24 Nov.2019, https://theintercept.com/2019/11/24/cia-mkultra-louis-jolyon-west/

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

[11] Caitlin Dickerson, “Veterans Used In Secret Experiments Sue Military For Answers,” NPR, 5 Sept. 2015, https://www.npr.org/2015/09/05/437555125/veterans-used-in-secret-experiments-sue-military-for-answers

[12] https://www.cchrint.org/2023/01/06/cia-psychiatrist-jolly-wests-1960s-lsd-mind-control-experiments/

[13] Psychotropic Drugs In The Year 2000 Use by Normal Humans, (Springfield, Illinois, Charles C. Thomas Publisher, 1971), pp. xii and xix

[14] Psychotropic Drugs In The Year 2000…, p. xx

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

[16] https://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, http://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, https://digitallibrary.un.org/record/1298436?ln=en

[17] https://www.ft.com/content/4a2e856c-4736-4b8b-9323-583bb1dbe8f4

[18] Mad in America: Bad Medicine and Enduring Mistreatment of the Mentally Ill, (Perseus Publishing, New York, 2002) pp, 176 and 208

[19] https://www.cchrint.org/2014/11/20/the-most-popular-drug-in-america-is-an-antipsychotic-and-no-one-really-knows-how-it-works/; https://www.alternet.org/2014/11/most-popular-drug-america-antipsychotic-and-no-one-really-knows-how-it-works

[20] https://www.cchrint.org/2022/06/10/mental-health-watchdog-updates-report-on-psychotropic-meds-role-in-violence/; https://www.cchrint.org/pdfs/violence-report.pdf

[21] https://www.cchrint.org/school-shooters/; https://www.cchrint.org/facts-reported-about-the-mass-shootings-in-california-ohio-and-texas/

[22] https://www.fiercebiotech.com/biotech/following-rejection-and-retractions-lykos-caps-chaotic-week-cutting-75-staff

[23] https://www.reuters.com/business/healthcare-pharmaceuticals/lykos-cuts-workforce-by-75-2024-08-15/; https://www.businesswire.com/news/home/20221116005130/en/

[24] https://www.cchrint.org/2019/06/26/cchr-warns-about-antidepressant-nasal-spray-esketamine-spravato-use-on-veterans/