Popular on s4story
- Can Your Inner Child Come Out and Play
- GENIUS EDGE DEFI™ Distributed Energy Flexible Infrastructure
- ARCH Dental + Aesthetics Unveils New Website for Enhanced Patient Experience
- Filipino Poet Wins First International Poetry Prize at London's Bermondsey Festival
- New Novel @UGMAN Exposes the Emotional Toll of Social Media
- Prymax Media & Technology Group Acquires 'Hidden Treasures' From Estate of Jewel Records Founder Stan Lewis
- Experience Trembling Firsthand with the New AgeMan® Tremor Simulator
- Exposing the Shadows: Books That Break the Rules
- TEDxInglewood Returns to The Miracle Theater on August 9, 2025 — Celebrating Bold Ideas and Community Energy
- Manhattan Boutique Real Estate Collaborates with InterContinental Hotels NYC in a Branding Partners Personalized Approach
Similar on s4story
- Dr. Jacqueline West Honored as Best Dentist in JAX by Folio Weekly
- Exciting News: Pivotal Health Solutions Acquires Revolutionary Portable Parallel Bars
- Mensa Foundation Prize Awarded to Neuroscientist-Pianist
- OPRAH.COM Featured Award-Winning Novel AS FAR AS YOU GO BEFORE YOU HAVE TO COME BACK now Available as Audiobook
- KeysCaribbean Vacation Home Rentals Offers Last-Minute Booking Discount of 15 Percent
- purelyIV Blog Named One of the Top 45 IV Therapy Blogs by Feedspot
- purelyIV Launches Mobile Iron Infusion Therapy for Patients with Iron Deficiency Anemia
- Smile Makers Dental Care Introduces FP1: East Bay's First Robotic-Assisted Full-Arch Implant Solution for Natural, Fixed Smiles
- Fray Fitness and Truemed Partner to Enable HSA/FSA-Funded Fitness Equipment Purchases
- Sploot Vets and DeepScan Launch Exclusive Regional U.S. Partnership to Bring Breakthrough Pet DNA Test to Market
FDA Rejects MDMA for Mental Health Treatment After Identifying Flawed Study Data
S For Story/10634426
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.
LOS ANGELES - s4story -- 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."
More on S For Story
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]
More on S For Story
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
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."
More on S For Story
- Dave Alber's Gothic Mystery The Curse of Living Knowledge Launches on Amazon in eBook & Paperback
- Anti-war groups protest vs US-NATO actions in Gaza, Iran, the Global South
- Dr. Jacqueline West Honored as Best Dentist in JAX by Folio Weekly
- Exciting News: Pivotal Health Solutions Acquires Revolutionary Portable Parallel Bars
- Miboxer Achieved New Goal in GILE 2025
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]
More on S For Story
- Jeopardy!'s Ken Jennings Headlines National Mensa Event
- Mensa Foundation Prize Awarded to Neuroscientist-Pianist
- New book, "High-Tech Heroes," redefines billionaire as someone who improves a billion lives
- A Call To Patriots and Veterans - Let's Help Trump Save The Republic
- Coming Soon : Different Worlds
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
Source: Citizens Commission on Human Rights
Filed Under: Health
0 Comments
Latest on S For Story
- Book 3 of "The Clio Project" Series Follows Military Squad to the Civil War and Back
- As Sober.Buzz Community Explodes It's Growth Globally it is Announcing "Spreading the Good BUZZ" Podcast Hosted by Josh Case Debuting July 7th
- Coming Soon: The Cottages at Powell Park Offer a Rare Blend of Charm, Convenience, and Community in Raleigh
- Young Kansas City Author Releases Second of 3 Books, Finding My Plate, on Kindle Direct Publishing
- CredHub and All County Property Management Franchise Corp. Partner to Empower Franchisees with Rental Payment Credit Reporting Solutions
- Pregis Shares 2024 Sustainability Report Highlighting Progress in Circular Product Innovation, Emissions Accountability, and Global Impact
- JOSHWAY Launches Children's Book, "JOSHWAY and the Power of Resilience"
- Initial Order Received from Vietnamese Maritime Security and Defense Services for Advanced Video Compression Solution: RMX; Stock Symbol: RMXI
- Keebos Launches New Universal Pearl Strap That Attaches to Any Phone Case
- Work 365 Launches Certified Provider Integration (CPI) Program to Help Distributors and CSPs Navigate Microsoft's Evolving Ecosystem
- Can Consciousness Shift a Nation?
- The Old Version of You Brought You Here. The New One Begins Now
- Dr. Danyel Nicole Black Launches New E-Book, The Queen's Order, Empowering Girls and Wome
- Five Aster Awards! Fusion Marketing Group Brings Home Big Wins in 2025!
- From Barrio to Transgender Pioneer: The Day that Changed Everything
- AI changes cryptocurrency market trading, TWL Miner launches new 1-day contract, giving away over $1 million
- A Himalayan Adventure Comes to Morris Plains – Meet Author K.A. Nayampalli
- A Global First: NaturismRE™ Launches the Global Urgency Index
- 14th CryptoSuper500 Report Releases: Bitcoin's Evolution into a Global Supercomputer
- Ross Toohey named Managing Director in Chesterfield, Missouri