Every psychedelic drug application should be rejected, and any drug that advances must be barred for minors, pregnant women, the elderly, those with impaired consent, and those with a history of violence and psychosis.
Jan Eastgate
President, CCHR International
October 9, 2026
Citizens Commission on Human Rights International submitted its comments to the Food and Drug Administration (FDA), opposing the agency approving any psychedelic drug for the treatment of a mental disorder or emotional distress. The FDA requested public comments regarding “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.”[1] Approval would add another class of psychotropic drugs with a high potential for adverse effects, including aggression, psychosis and violence.
CCHR’s submission recognizes that the FDA may still proceed with psychedelic drug approvals and recommends irreducible minimum conditions for consent and controlled and accountable administration, while not a concession that these products can be made acceptably safe. It has already issued Commissioner Priority Vouchers (CNPV) to three psychedelics under study. This shortens review of a later marketing application from about ten to twelve months to one to two months and is treated as meeting four criteria: addressing a health crisis in the United States; delivering more innovative cures for the American people; addressing unmet public health needs; and increasing domestic drug manufacturing as a national security issue.[2]
Psychiatric drugs, including psychedelics, are symptom treatments, not cures—and far from innovative, they are a return to the same model the American Psychiatric Association already describes for existing medications: they do not rid a person of a mental illness or cure it.[3] Psychedelics’ proposed use is still the suppression or temporary distress in conditions that have no confirmatory medical test and no demonstrated disease-eradicating mechanism.
Existing psychiatric drugs already carry serious risks and have not cured any mental disability. A new class of perception-altering drugs is now offered to treat problems prior psychiatric drugs have been documented to cause. That is not a scientific revolution addressing a “mental health crisis.” It is a replay: bold promises before long-term evidence, aggressive promotion before safety is established, and “innovation” language covering a high-risk public-health experiment. The playbook is recycled, using pitches similar to those used with SSRI (serotonin) antidepressants when launched in 1988.
Classic psychedelics—LSD, psilocybin, DMT (structurally related to psilocybin), and mescaline—are also serotonergic agents and are already promoted as the “alternative,” including claims they can improve sexual function.[4] The National Institute on Drug Abuse (NIDA) warns: “The effects of hallucinogens like LSD can be described as drug-induced psychosis—distortion or disorganization of a person’s capacity to recognize reality, think rationally, or communicate with others.” Further, “Use of hallucinogenic drugs also produces tolerance to other drugs in this class, including psilocybin and peyote.”[5]
Psychedelics are contraindicated in pregnancy, epilepsy or other seizure disorders, and severe cardiovascular disease (including uncontrolled blood pressure, heart failure, coronary artery disease, or prior heart attack or stroke). Because they activate serotonin receptors in the brain, they can cause life-threatening serotonin syndrome if used with other medications or substances that also raise serotonin levels, including SSRI or MAOI antidepressants that cannot be tapered before use.[6]
Layering psychedelics onto people already prescribed multiple psychotropics, or already misusing substances, could cause predictable interactions: more routes to psychosis, paranoia, and loss of control.
Those risks are being justified by trials that cannot cleanly show the drug caused a reported benefit. A blinded study hides which treatment a participant received so that expectation is not scored as a drug effect. In a single-blind trial, the participant does not know. In a double-blind trial, the participant, the clinicians, and the raters do not know. Psychedelic trials break that protection. The FDA’s own July 2026 guidance states that a traditional placebo is problematic.[7] The acute effects are conspicuous. Participants, therapists, and raters can often infer assignment from the presence or absence of a “trip,” so expectancy and disappointment split across arms and can inflate apparent efficacy.
A 2024 review of 48 trials found that most did not report whether blinding held; in those that did, “blinding was unsuccessful,” and “virtually all participants [were] able to correctly identify which group they were in.”[8] Niacin, methylphenidate, diphenhydramine, and micro-doses of the same compound produce some sensation but not a classic psychedelic experience. Measured guess rates remain very high.[9]
What does not follow is treating failed-blind studies as evidence of “innovative cures,” or awarding a voucher that swaps political priority for the time needed to tell whether any effect comes from the drug, the setting, or the expectation of a trip. The FDA should not grant or use these vouchers for psychedelic products, and it should not treat a shortened review as a substitute for substantial evidence of safety and effectiveness.
Informed Consent Nullified
Informed consent is already weak in ordinary psychiatric prescribing. In psychedelic sessions, it is effectively nullified. A form signed beforehand cannot prevent serotonin syndrome, a manic switch, a year of derealization, a suicide attempt, or a violent act during psychosis. Those events may occur after the person can no longer make an informed choice.
Consent cannot neutralize these outcomes: the drug removes the perception and judgment consent requires. Medical literature, including American Psychiatric Association publications, acknowledges that a person under the influence may be unable to give or withdraw consent. Pre-signed waivers allowing restraint or sedation during a session create legal and ethical hazards.[10]
Psychedelics Induce Violence
A consistently neglected issue in psychiatric-drug policy is the association—through adverse reaction, withdrawal, and disinhibition—between prescription psychotropics and violent behavior. Adding psychedelics to psychiatric drug options raises the risk of acute psychosis, paranoia, hallucinations, and dissociative states that impair judgment and self-control.
A 2025 review reported impaired judgment and mental function as a reason psychedelic use can produce abnormal behavior, including aggressive behavior. NIDA has cited a survey of nearly 2,000 people who had a “challenging” recreational psychedelic experience: 11% said they put themselves or others at risk of harm.[11]
A 2026 paper in Psychiatry, Psychology and Law draws on a dataset of 626 homicides committed while under the influence of psychedelics (1962–mid-2025) and presents a 22-case series. The authors say psychotic symptoms triggered by psychedelic use appeared in the majority of the series; some offenders had prior psychedelic-associated psychosis. Policy points they draw: emergency response to substance-associated psychosis, and abstinence after a prior psychotic reaction.[12]
Documented Violence Cases
- A Vice investigation, “Killer High,” catalogued at least 11 LSD-related homicides between 2016 and 2019. The piece described previously stable people whose conduct changed under the drug—not a roster of career criminals.[13] Vice reported:
- In 2018, a 22-year-old in Florida took LSD and stabbed his girlfriend’s father to death. A New York case involved a man who drowned his infant daughter while high on LSD.[14]
- In 2020, a Canadian university hockey player was acquitted of breaking and entering and aggravated assault after attributing his conduct to psilocybin mushrooms.[15]
- Seagoville, Texas, 2022: Russell Ragsdale shot his roommate while high on mushrooms (phone showed he’d purchased and used that day); sentenced to over five years in federal prison.[16]
- Lodi, California, Oct. 3, 2023: Scott Sherman, 40, shot Felix Makinano twice in the back outside a bar after drinking and taking psilocybin. Prosecutors said he became paranoid. Sentenced in June 2026 to 50 years to life plus three years.[17]
- Alaska Airlines Flight to Washington, October 2023: Joseph D. Emerson, an off-duty airline pilot, attempted to shut down a commercial aircraft’s engines in flight after taking psychedelic mushrooms about 48 hours earlier. Emerson told police he thought he was dreaming and believed pulling the handles of a fire-extinguishing system, which cuts fuel to the aircraft’s engines, would cause him to “wake up,” court documents say.[18] In November 2025, he was sentenced in Federal court to credit for time served and supervised release for three years. U.S. District Judge Amy Baggio said the case “offers a cautionary tale worth telling beyond the confines of this case.” A state court had sentenced him to 50 days in jail, with credit for time served, plus five years of probation, 664 hours of community service—eight hours for each person he endangered—and over $60,000 in restitution.[19]
- Gorge Amphitheatre / Beyond Wonderland, Washington, 2023: James M. Kelly, an active-duty soldier of the U.S. Army at Joint Base, told investigators he was hallucinating on mushrooms, believed the world was ending, and retrieved a gun. He killed two women and injured three others, including his girlfriend.[20]
- San Francisco, California, Dec. 31, 2023: Evan Supinski, a Marine combat veteran, allegedly took three large mushrooms, stood naked on a car, fired an unregistered gun, threatened his landlord as “Satan,” and said he was “in the Garden of Eden.” Defense: mushroom-fueled psychotic break and may have been exacerbated by meds prescribed for PTSD. Two days before the New Year’s Eve incident, Supinski “received a double dose of his medication.”[21]
- Regina, Saskatchewan, Canada, Jan. 2025: Kristopher Soby fatally stabbed partner Amber Robson after an “extreme and reckless” mushroom dose bought online. She had called 911 for his episode. Soby was experiencing drug-induced psychosis at the time of the killing. After pleading guilty to manslaughter and assaulting a police officer, the 40-year-old received a seven-and-a-half-year prison sentence.[22]
- Bellingham, Washington, May 2026: Brenda Wilder-Brown was charged with two counts of attempted murder of children ages 9 and 4 after alleged psilocybin use. Police found suspected mushrooms and a bloody knife, and she described a “blackout.” The 4-year-old was found with 15 knife wounds when police arrived, according to court records. There was also evidence that they were strangled. Both siblings were taken to the hospital, though the 9-year-old was unharmed. Charges are allegations.[23]
- British Columbia, Canada, March 2019: Leon-Jamal Daniel Barrett was acquitted of sexual assault, break-in, and obstructing police on an automatism defense after mushrooms. The judge accepted involuntary conduct. He had also stabbed himself in the chest. Shows both alleged harm and how the hallucinogen “put him in a state of automatism that rendered him not criminally liable for his actions,” which is already a courtroom theory.[24]
- Akron, Ohio, June 2025: Police say Antoine Pixley, 21, high on psilocybin, stabbed roommate Dierre Williams to death and stabbed a relative, telling detectives the victims had “turned into demons.”[25]
- Calgary, Canada, June 2023: Alex Xu admitted killing his mother with a rock while on LSD. His lawyer argued his client was so high on the hallucinogenic drug that he believed he was killing a demon and should be found guilty of the lesser offence of manslaughter. A mistrial was declared in May 2026.[26]
These incidents align with forensic patterns already described for other psychotropics. Psychologist David Kirschner, who studied 30 young murderers, reported that most had recently been treated with psychiatric drugs, often stimulants or antidepressants. The drugs didn’t prevent the violence; they enabled it by disinhibiting self-control.[27]
The forensic series of psychedelic-associated homicides includes people with no prior psychosis; some of the prescribed-ketamine lawsuits involve clinic product, not street product. Until advocates produce comparative violence and self-harm data in real-world prescribed use, FDA has no scientific basis to treat the case record as irrelevant to an approval decision.
Unregulated Use and Access: A Looming Public Health Crisis
There are already at least a thousand U.S. clinics offering ketamine-assisted therapy off-label.[28] The market has grown with limited FDA oversight of off-label ketamine practice. Matthew Perry’s 2023 death shows how prescribed use can slide into misuse. The Los Angeles County Medical Examiner ruled that he died accidentally from “the acute effects of ketamine,” with anesthetic-level concentrations from sources other than his last prescribed infusion.[29] He was first prescribed the drug in a ketamine infusion clinic a week and a half before his death, then he received it illicitly.
A STAT investigation documented inconsistent dosing, weak screening, and clinics promoting unproven uses and “special blends.”[30]
Fraudulent Marketing
Psychedelic marketing is wrapped in deceptive language—“plant medicine,” “natural healing,” “resetting” or “rewiring” the brain or addressing treatment-resistant conditions.[31] Those are narratives, not established mechanisms. UK psychiatrist Joanna Moncrieff and colleagues have shown that no biological lesion has been scientifically validated as the cause of mental disorders.[32]
Claims that psychedelics “correct” brain dysfunction are misleading. Prof. Moncrieff warns that “psychedelics do not produce the miracle cures people are led to expect, as experience with ketamine confirms.[33] Some people may feel a little better after a treatment, and then the effect wears off and they come for another one and another one, and get established on long-term treatment just as people do on antidepressants.”
A 2025 paper pointed to misrepresentation and bias in the psychedelic literature: pharmaceutical companies have a vested interest in bringing these products to market. “As demonstrated during the opioid crisis, pharmaceutical companies are financially driven and are willing to invest their money into any drug that can potentially boost revenue (whether it has positive or negative effects on an individual’s health).” The same study stated that companies “are concerned with profit over ethical or well-constructed research” and have marketed drugs “in a variety of unethical ways intended to increase sales including falsifying research findings, deceptively advertising.…”[34]
The International Journal of Environmental Research and Public Health found that much published psychedelic research lacks the rigor such claims require, while listing fear, panic, hallucinations, nausea, heart-rate changes, and “impaired thought processes and perception” that can produce dangerous behavior. The same paper flagged misleading claims that ketamine treats suicidality.[35]
A psychedelic session can last hours, leave judgment impaired, and raise heart rate and blood pressure. Trials have also recorded suicidal ideation, and session settings have already produced allegations of sexual boundary violations. CCHR’s position is that if any of these drugs move toward approval, the limits should be written into the label and the Risk Evaluation and Mitigation Strategy (REMS) before the first commercial dose, not after a clinic scandal.
CCHR’s recommendations
These include:
- Prohibitions. No psychedelic to anyone under 18; during pregnancy or breastfeeding; or to an older adult with dementia, Alzheimer’s disease, or any other condition that impairs understanding of consent. No dose given under court order, in custody, or in any other setting where refusal is not free. Exclude anyone with a history of diagnosed psychosis, schizophrenia, or mania; past or active suicidal intent, a recent attempt or plan, self-injury, or a recent psychiatric hospitalization; and anyone with a history of violence, assault, homicidal ideation, or impulsive aggression.
- Labeling. Require a class boxed warning and a Medication Guide covering psychiatric destabilization, impaired judgment, cardiovascular stress, and abuse.
- How it is given. Two trained staff in the room. No take-home supply of the psychedelic. No co-administration with interacting drugs (polypharmacy). Do not discharge a person while still impaired or allow them to drive, use machinery, or care for children.
- Supply control. Prescription-drug monitoring checks, unannounced inventory audits of a clinic or prescriber’s supply, and same-day reporting of missing doses to the Drug Enforcement Administration. Treat willful diversion or falsified records as chargeable under existing law, not only as a clinic fine.
- Harm reporting. Report sexual contact or violence involving a client who was given the drug to the REMS administrator, the Drug Enforcement Administration, the medical licensing board, and law enforcement within 72 hours.
- Follow-up. Check the person at 24 hours and at 7, 30, and 90 days. No further dose after new suicidality, psychosis, or a cardiac event.
No psychedelic has been shown to correct a confirmed biological cause of depression, PTSD, or any other psychiatric diagnosis, and no such confirmatory test exists for the diagnoses themselves. A drug that cannot identify, remove, or reverse a disease process cannot be an innovative cure for it. It can only be another psychotropic added to a class that already fails that test.
Approval without the above limits would trade one set of psychiatric-drug harms for another, this time with a substance that alters perception for hours and in unregulated clinics.
[1] U.S. Food and Drug Administration (FDA), Regulations.gov, Docket No. FDA-2026-N-7542, Document No. FDA-2026-N-7542-0001, https://www.regulations.gov/document/FDA-2026-N-7542-0001
[2] “FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests,” Food & Drug Administration, 17 June 2025, https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests
[3] “Psychiatric Medications: An Overview,” American Psychiatric Association, https://www.psychiatry.org/patients-families/psychiatric-medications-an-overview-1
[4] Ryan O’Hare, “Psychedelic experiences linked with improved sexual function,” Imperial, 7 Feb. 2024, https://www.imperial.ac.uk/news/251313/psychedelic-experiences-linked-with-improved-sexual/
[5] “How Do Hallucinogens (LSD, Psilocybin, Peyote, DMT, and Ayahuasca) Affect the Brain and Body?” National Institute of Drug Abuse, https://nida.nih.gov/publications/research-reports/hallucinogens-dissociative-drugs/how-do-hallucinogens-lsd-psilocybin-peyote-dmt-ayahuasca-affect-brain-body/
[6] Gowri Awagam, “Medical Contraindications to “Classic” Psychedelic Use,” University of CA San Francisco, 22 Mar. 2022, https://psychedelics.ucsf.edu/blog/medical-contraindications-to-classic-psychedelic-use/
[7] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations; PDF: https://www.fda.gov/media/169694/download; FDA psychedelics hub: https://www.fda.gov/drugs/resources-drugs/psychedelic-drugs
[8] Alexander Wen, et al., “A Systematic Review of Study Design and Placebo Controls in Psychedelic Research,” Psychedelic Med (New Rochelle), Mar. 2024, https://pmc.ncbi.nlm.nih.gov/articles/PMC11658677/
[9] Jacob S Aday, et al., “Addressing blinding in classic psychedelic studies with innovative active placebos,” Int J Neuropsychopharmacol, 4 Apr. 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC12038243/
[10] Brian Holoyda, M.D., M.P.H., “Psychedelic Psychiatry: Preparing for Novel Treatments Involving Altered States of Consciousness,” Psychiatric Services, 14 Oct. 2020, https://ps.psychiatryonline.org/doi/10.1176/appi.ps.202000213
[11] Norman Miller, “Psychedelics: Safety and Efficacy,” Int J Environ Res Public Health, 21 Jan. 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11855591/
[12] Jesse J. Norris, Brian Holoyda, “Homicides associated with psychedelic use: Psychiatric features, risk factors and sentencing outcomes,” Psychiatry, Psychology and the Law, 16 Apr. 2026, https://www.tandfonline.com/doi/full/10.1080/13218719.2026.2718113
[13] Gavin Butler, “Killer High: Exploring the Phenomenon of LSD-Fueled Murder,” VICE, 25 Oct. 2020, https://www.vice.com/en/article/acid-lsd-fuelled-murder-homicide/
[14] Gavin Butler, VICE, 25 Oct. 2020
[15] Manisha Krishnan, “A Hockey Player Blamed Shrooms for His Brutal Attack on a Woman. It Worked,” VICE, 12 Mar. 2020, https://www.vice.com/en/article/a-hockey-player-blamed-shrooms-for-his-brutal-attack-on-a-woman-it-worked/
[16] Lillie Davidson, “North Texas man who shot roommate while high on mushrooms sent to federal prison,” Fort Worth Star-Telegram, 19 July 2025, https://www.star-telegram.com/news/local/crime/article311007690.html
[17] Ken Allard, “Man who murdered someone while high on ‘magic mushrooms’ sentenced to prison,” Fox 40 News, 19 June 2026, https://fox40.com/news/local-news/lodi/man-who-murdered-someone-while-high-on-magic-mushrooms-sentenced-to-prison/
[18] Pete Muntean, et al., “Off-duty pilot accused of trying to shut off airliner’s engines mid-flight said he took ‘magic mushrooms’ 48 hours before the incident, court documents say,” CNN, 25 Oct. 2023, https://www.cnn.com/2023/10/25/us/alaska-airlines-pilot-wednesday/index.html
[19] “No prison time for off-duty pilot who tried to cut a flight’s engines midair, judge rules,” NBC News, 17 Nov. 2025,https://www.nbcnews.com/news/us-news/no-prison-time-duty-pilot-tried-cut-flights-engines-midair-judge-rules-rcna244520
[20] Daisy Zavala Magaña, “Gorge Shooting suspect was hallucinating from mushrooms, court documents say,” Seattle Times, 21 June 2023, https://www.seattletimes.com/seattle-news/law-justice/gorge-shooting-suspect-was-hallucinating-from-mushrooms-court-documents-say/
[21] Nora Mishanec, “S.F. man was on psychedelic mushrooms during Richmond District shooting: ‘He was calling me Satan,’” San Francisco Chronicle, 27 Sept. 2024, https://www.sfchronicle.com/bayarea/article/mushrooms-shooting-richmond-district-18652430.php
[22] Brandon Harder, “Mother grieves Regina daughter killed by partner in drug-induced psychosis,” The Leader Post, 15 Jan. 2025, https://leaderpost.com/news/crime-courts/immense-grief-floods-regina-sentencing-of-man-who-killed-his-partner-while-in-drug-induced-psychosis/
[23] Hannah Edelman, “Court docs: Bellingham woman charged with attempted murder was using psilocybin,” The Chronicle, 20 May 2026, https://www.chronline.com/stories/court-docs-bellingham-woman-charged-with-attempted-murder-was-using-psilocybin,402764
[24] Jason Proctor, “B.C. man acquitted of sexual assault after blaming ‘automatism’ on magic mushrooms,” CBC, 17 June 2025, https://www.cbc.ca/news/canada/british-columbia/magic-mushrooms-automatism-sexual-assault-1.7562554
[25] “Suspect, high on mushrooms, killed roommate in stabbing attack, Akron police say,” Cleveland.com, 10 June 2025, https://www.cleveland.com/metro/2025/06/suspect-high-on-mushrooms-killed-roommate-in-stabbing-attack-akron-police-say.html
[26] “Mistrial declared in case of Calgary man who admitted to killing mom while high on LSD,” CBC, 13 May 2026, https://ca.news.yahoo.com/mistrial-declared-case-calgary-man-013049800.html
[27] David Kirschner, PhD, “Mass shooters received only limited treatment,” The National Psychologist, 26 July 2017
[28] Mark Gold, M.D., “Thousands of Clinics Treat Patients With Ketamine. Are They Safe?” Psychology Today, 1 Aug. 2026, https://www.psychologytoday.com/us/blog/addiction-outlook/202507/thousands-of-clinics-treat-patients-with-ketamine-are-they-safe
[29] Richard Winton, Emily Alpert Reyes, “Matthew Perry died from acute effects of ketamine, officials rule,” Los Angeles Times, 15 Dec. 2023, https://www.latimes.com/california/story/2023-12-15/matthew-perry-death-cause-ketamine
[30] Megan Thielking, “Ketamine gives hope to patients with severe depression. But some clinics stray from the science and hype its benefits,” STAT, 24 Sept. 2018, https://www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/; KETALAR (ketamine hydrochloride) injection, Prescribing Information, FDA, revised 2026, https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/016812s057lbl.pdf; Ketamine Store Warning Letter, Food and Drug Administration, 23 June 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ketamine-store-wwwketaminestoreorg-725147-06232026
[31] Lindsay Calliandra Rose, “The Transformative Power of Ayahuasca and the Impacts on Mental Health,” Plant Medicine People, https://www.plantmedicinepeople.com/blog/ayahuasca-mental-health-impacts;
[32] https://www.cchrint.org/2026/05/05/plant-based-psychedelics-push-masks-synthetic-drugs-and-billion-dollar-profits/; “Medicating misery by doling out antidepressants is based on a myth: NHS psychiatrist Professor Joanna Moncrieff reveals the shameful truth about Big Pharma,” The Daily Mail, 13 Jan 2025, https://www.dailymail.co.uk/health/article-14279653/Medicating-misery-antidepressants-myth-NHS-psychiatrist-PROFESSOR-JOANNA-MONCRIEFF.html; Joanna Moncrieff, Ruth E. Cooper, Tom Stockmann, Simone Amendola, Michael P. Hengartner and Mark A. Horowitz, “The serotonin theory of depression: a systematic umbrella review of the evidence,” Molecular Psychiatry, 20 July 2022, https://www.nature.com/articles/s41380-022-01661-0
[33] https://www.cchrint.org/2025/07/11/psychedelics-for-vets-exploitation-failed-science/; Joanna Moncrieff, M.D., “Psychedelics: The New Psychiatric Craze,” Mad in America, 2 Sept. 2021, https://www.madinamerica.com/2021/09/psychedelics-new-psychiatric-craze/
[34] https://www.cchrint.org/2026/05/05/plant-based-psychedelics-push-masks-synthetic-drugs-and-billion-dollar-profits/; Norman Miller, “Psychedelics: Safety and Efficacy,” Int J Environ Res Public Health, 21Jan. 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11855591/
[35] Norman Miller, “Psychedelics: Safety and Efficacy,” Int J Environ Res Public Health, 21 Jan. 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11855591/
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