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.
By Jan Eastgate
President CCHR International
June 14, 2024
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] CCHR wants it to stay that way, warning against adding any psychedelic drugs to the number of whopping amount 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]
Lykos Therapeutics, formerly known as the MAPS (Multidisciplinary Association for Psychedelic Studies) Public Benefit Corporation, 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.[7] The company raised $100 million in financing in an attempt to win FDA approval.[8]
Shares for companies focused on psychedelic drugs plummeted following the FDA panel’s decision. It’s a blow to Lykos, but also a setback hitting investor confidence in an array of publicly traded companies working to bring psychedelics to clinics, market researchers say.[9] MDMA and other psychedelics have been projected to be $10 billion a year industry.[10]
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.[11]
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.[12]
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.[13] 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 episodes.[14]
CCHR says that replacing antidepressants with psychedelics is like switching seats on the Titanic. It said 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.[15]
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.[16]
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.”[17]
CCHR urges further rejection of psychedelic drug applications, warning that the current push for these psychedelic 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.
For more information on this issue, read CCHR’s other articles:
CCHR Calls for Ceasing Psychedelic Drug Trials on Military and Veterans
CCHR Cautions Legislators as FDA Weighs Approval of Psychedelics Amid Rising Violence
CIA Psychiatrist Louis “Jolly” West’s 1960s LSD Mind-Control Experiments Come Back to Haunt America
Replacing Prozac with LSD is Like Switching Seats on the Titanic
Repurposing Psychotropic Drugs to Treat Physical Ills Puts Patients in Danger
Renewed Psychedelic Drug Research is a Bad “Trip” for Mental Health
The Latest in Psychiatry’s ‘Say Yes to Drugs’ Campaign—Just Take Some Ecstasy And You’ll Be Fine
References:
[1] 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; https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-flags-concerns-mdma-assisted-ptsd-treatment-2024-05-31/; https://www.nature.com/articles/d41586-024-01622-3
[2] https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-flags-concerns-mdma-assisted-ptsd-treatment-2024-05-31/
[3] 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
[4] 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
[5] “3,4-Methylenedioxymethamphetamine Assisted Psychotherapy for Post-Traumatic Stress Disorder (PTSD) Draft Evidence Report,” Institute for Clinical and Economic Review, March 26, 2024, pp. 6 & 8, https://psychedelicalpha.com/wp-content/uploads/2024/03/PTSD_Draft-Report_For-Publication_03262024.pdf
[6] Jacob Bell, “FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns,” BioPharm Dive, 4 June 2024, https://www.biopharmadive.com/news/mdma-fda-advisers-vote-lykos-post-traumatic-stress-disorder-ptsd/718011/
[7] Oshan Jarrow, “MDMA’s federal approval drama, briefly explained,” VOX, 4 Jun. 2024, https://www.vox.com/future-perfect/353752/mdma-fda-approval-hearing-lykos-blinding-misconduct-allegations
[8] Steve Gelsi, “MDMA therapy company Lykos raises $100M in Series A funding as it eyes FDA approval,” MarketWatch, 5 Jan. 2024, https://www.marketwatch.com/story/mdma-therapy-company-lykos-raises-100m-in-series-a-funding-as-it-eyes-fda-approval-985df985
[9] “Psychedelic Stocks Tank After FDA Advisors Shoot Down MDMA Therapy For PTSD,” Forbes, 5 June 2024, https://www.forbes.com/sites/roberthart/2024/06/05/psychedelic-stocks-tank-after-fda-advisors-shoot-down-mdma-therapy-for-ptsd/?sh=639b0ef85010
[10] Will Yakowicz, “The Future of Psychedelic Medicine Might Skip the Trip,” Forbes, 25 June 2021, https://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
[11] https://www.cchrint.org/2020/05/12/repurposing-psychotropic-drugs-to-treat-physical-ills-puts-patients-in-danger/ citing https://www.drugabuse.gov/publications/research-reports/mdma-ecstasy-abuse/what-are-effects-mdma; “MDMA: What you need to know about Molly,” Medical News Today, https://www.medicalnewstoday.com/articles/297064#fast-facts-on-mdma; https://nida.nih.gov/sites/default/files/1763-mdma-ecstasy-abuse.pdf
[12] Kelly O’Meara, “The Latest in Psychiatry’s ‘Say Yes to Drugs’ Campaign—Just Take Some Ecstasy And You’ll Be Fine” 28 May 2015, https://www.cchrint.org/2015/05/28/psychiatryecstacycampaign/ citing https://www.dea.gov/sites/default/files/2023-03/Ecstasy-MDMA%202022%20Drug%20Fact%20Sheet.pdf
[13] https://www.cchrint.org/2024/06/07/high-antidepressant-use-calls-for-a-de-prescribing-de-escalation-policy/
[14] Sophie Putka, “What Patients Should Know Before Agreeing to Psychedelic Therapy,” MedPage Today, 11 April 2024, https://www.medpagetoday.com/psychiatry/generalpsychiatry/109622#:~:text=Appelbaum%20added%20that%20a%20description,psychotic%20episodes%2C%22%20Appelbaum%20explained
[15] https://herb.co/learn/whats-the-difference-between-natural-vs-synthetic-psychedelics; https://www.dlapiper.com/en/insights/publications/2023/01/state-psychedelic-regulation-oregon-and-colorado-taking-the-lead
[16] “What You Need to Know About SB23-290, Colorado’s Natural Medicine Health Act Implementation Bill,” Vincente, 3 May 2023; “Harming While Healing?: The Oppressive Nature of Psychedelic-Centric Drug Policy,” Psychedelics Today, https://psychedelicstoday.com/2023/11/17/harming-while-healing-the-oppressive-nature-of-psychedelic-centric-drug-policy/; https://www.axios.com/local/denver/2024/03/07/colorado-draft-rules-psychedelic-healing-centers; https://digitalcommons.wku.edu/cgi/viewcontent.cgi?article=1828&context=stu_hon_theses
[17] Will Yakowicz, “The Future of Psychedelic Medicine Might Skip the Trip,” Forbes, 25 June 2021, https://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
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