FDA Panel Overwhelmingly Rejects MDMA Psychedelic as Mental Health Treatment

CCHR applauds the panel's decision amid concerns over biased clinical trials and risks such as heart attacks, strokes, psychosis, and sexual abuse of patients during prescribed psychedelic trips.

LOS ANGELES - June 17, 2024 - PRLog -- A panel of experts from the Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee has overwhelmingly rejected the use of the psychedelic MDMA, also known as Ecstasy and Molly, for post-traumatic stress disorder (PTSD), after finding that its purported efficacy in clinical trials does not outweigh the risks.[1] MDMA is currently illegal in the U.S. and the FDA has so far never approved the therapeutic use of the mind-altering drug.[2] The mental health industry watchdog, Citizens Commission on Human Rights International, wants it to stay that way, warning against adding any psychedelic drugs to the number of prescription psychotropics already in use.

FDA staff said MDMA may raise the risk of heart attacks and strokes by increasing patients' pulse and blood pressure. They also cited the vulnerability of patients under the influence of the drug. "We are particularly concerned that serious harm could result" and "may include, but are not limited to, events resulting in hospitalization or death, events that put patients at risk for hospitalization or death, and events with significant negative consequences."[3]

The Institute for Clinical and Economic Review (ICER), an independent scientific group that evaluates treatments and their prices, earlier raised questions about the research behind MDMA. In a vote, advisers to ICER decided nearly unanimously that the alleged benefits of the drug had not been proven.[4] ICER highlighted the placebo bias and ethical concerns in the data presented to the FDA. Furthermore, "Based on public reports, there is no question that, despite the trial requiring dual treatment by one male and one female therapist, boundaries, including sexual boundaries, were severely crossed with at least one patient…. Nearly everyone we spoke with discussed how MDMA breaks down barriers, heightens suggestibility, and creates a substantial risk with any therapists who might choose to take advantage of patients."[5]

Kim Witczak, the FDA's advisory panel's consumer representative, said: "I have real concerns with the validity of the data and the allegations of misconduct. I can't in good conscience support something where this many harms are being reported and just say, 'Oh, someone somewhere is investigating it.'"[6]

The company which made the application to the FDA for MDMA approval and is now fielding criticism over the integrity of its clinical trial data discussed at the FDA hearing. It had raised $100 million in financing in an attempt to win FDA approval.

Shares for companies focused on psychedelic drugs plummeted following the FDA panel's decision.  It is seen as a setback, hitting investor confidence in an array of publicly traded companies working to bring psychedelics to clinics, market researchers say. MDMA and other psychedelics have been projected to be $10 billion a year industry.[7]

The drug already has a particularly bad side effect profile. The National Institute of Drug Abuse warns MDMA causes involuntary jaw clenching, illogical or disorganized thoughts, panic attacks and in severe cases, a loss of consciousness and seizures. MDMA is also addictive, can interfere with the body's ability to regulate temperature, and can raise heart rate to a dangerous level.[8]

The Drug Enforcement Administration warns ecstasy—the street name for MDMA—can cause "confusion, anxiety, depression, paranoia, sleep problems, and drug craving," which may last weeks after ingestion.[9]

Yet psychedelics are marketed as the alternative for antidepressants, which have in recent years been exposed in the media and in drug regulatory agency warnings as having side effects such as suicide, cardiac problems, sexual dysfunction, severe withdrawal effects and lack of efficacy.[10] This has inadvertently given license to psychedelic pushers and manufacturers to advocate psychedelics as alternatives.

U.S. psychiatrist Paul S. Appelbaum wrote that the risks go beyond altered perceptions or changes to personality to include acute and sustained psychiatric symptoms, including severe anxiety and the possibility of triggering manic or psychotic episode.

CCHR says that replacing antidepressants with psychedelics is like switching seats on the Titanic, adding that the marketing gimmicks used to "sell" psychedelics imply the drugs are harmless, calling them "natural medicines," referring to psilocybin and mescaline, while synthetic psychedelics include MDMA and LSD.[11]

Jan Eastgate, President of CCHR International, warns, "If approved, they would likely then be promoted on TV direct-to-consumer marketing, giving the drugs a tacit 'approval' that they are safe to take, and, therefore also safe to abuse." Already, in 2022, it was estimated that around 2.1 million people in the U.S. had used ecstasy in the previous year, with the highest percentage of those aged 18 to 25.[12]

In 2022, Colorado enacted the Natural Medicine Health Act (NMHA), which provides psychedelics for adults 21 years and older, passing it off "equitable access to natural psychedelic medicine." In March 2024, the Colorado Office of Natural Medicine released draft regulations for those administering psilocybin, outlining training needed in order to obtain a license. In an audacious move, some proponents have argued that, as the drug has "spiritual properties," any government regulation could violate First Amendment constitutional rights—freedom of religion.[13]

CCHR condemns what it views as a profit-driven scheme, using unscientific marketing and invoking the need for constitutional protection. They draw parallels to the late 1980s when SSRI antidepressants were marketed as correcting a "chemical imbalance" in the brain—a claim now definitively proven false.

Forbes reports prescription sales for antidepressants are estimated to be $50 billion and "while biotech analysts say that FDA-approved psychedelic-assisted therapy, with drugs like psilocybin and MDMA, could seize $10 billion in annual sales by targeting the treatment-resistant depression subcategory, the real opportunity lies in replacing drugs like Prozac, Zoloft and other selective serotonin reuptake inhibitors."[14]

CCHR urges further rejection of psychedelic drug applications, warning that the current push for these substances is a hallmark of profit-driven tactics by the pharmaceutical industry, psychiatrists, and unregulated psychedelic clinics—ultimately exposing Americans to more damaging mind-altering drugs.

About CCHR: CCHR was founded in 1969 by the Church of Scientology and the late Dr. Thomas Szasz, Professor of Psychiatry, State University of New York Upstate Medical University. It has helped achieve over 190 laws that protect patients from coercive psychiatric practices.

[1] www.msn.com/en-us/health/other/fda-staff-raises-concerns-about-ecstasy-drug-s-safety-in-report/ar-BB1nozAn; www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-flags-concerns-mdma-assisted-ptsd-treatment-2024-05-31/; www.nature.com/articles/d41586-024-01622-3

[2] www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-flags-concerns-mdma-assisted-ptsd-treatment-2024-05-31/

[3] www.msn.com/en-us/health/other/fda-staff-raises-concerns-about-ecstasy-drug-s-safety-in-report/ar-BB1nozAn

[4] www.msn.com/en-us/health/other/fda-staff-raises-concerns-about-ecstasy-drug-s-safety-in-report/ar-BB1nozAn

[5] psychedelicalpha.com/wp-content/uploads/2024/03/PTSD_Draft-Report_For-Publication_03262024.pdf

[6] www.biopharmadive.com/news/mdma-fda-advisers-vote-lykos-post-traumatic-stress-disorder-ptsd/718011/

[7] www.forbes.com/sites/willyakowicz/2021/06/23/the-future-of-psychedelic-medicine-might-skip-the-trip-rick-doblin-bryan-roth-mindmed-darpa-maps/?sh=d69e851244fd

[8] www.cchrint.org/2020/05/12/repurposing-psychotropic-drugs-to-treat-physical-ills-puts-patients-in-danger/ citing www.drugabuse.gov/publications/research-reports/mdma-ecstasy-abuse/what-are-effects-mdma; www.medicalnewstoday.com/articles/297064#fast-facts-on-mdma; nida.nih.gov/sites/default/files/1763-mdma-ecstasy-abuse.pdf

[9] www.cchrint.org/2015/05/28/psychiatryecstacycampaign/ citing www.dea.gov/sites/default/files/2020-06/Ecstasy-MDMA-2020_0.pdf

[10] www.cchrint.org/2024/06/07/high-antidepressant-use-calls-for-a-de-prescribing-de-escalation-policy/

[11] herb.co/learn/whats-the-difference-between-natural-vs-synthetic-psychedelics; www.dlapiper.com/en/insights/publications/2023/01/state-psychedelic-regulation-oregon-and-colorado-taking-the-lead

[12] www.addictiongroup.org/resources/mdma-statistics/

[13] psychedelicstoday.com/2023/11/17/harming-while-healing-the-oppressive-nature-of-psychedelic-centric-drug-policy/; www.axios.com/local/denver/2024/03/07/colorado-draft-rules-psychedelic-healing-centers; digitalcommons.wku.edu/cgi/viewcontent.cgi?article=1828&context=stu_hon_theses

[14] www.forbes.com/sites/willyakowicz/2021/06/23/the-future-of-psychedelic-medicine-might-skip-the-trip-rick-doblin-bryan-roth-mindmed-darpa-maps/?sh=d69e851244fd