Ketamine Widely Dispensed Despite FDA Warning It’s Not Approved for Psychiatric Use

Ketamine Widely Dispensed Despite FDA Warning It’s Not Approved for Psychiatric Use
The FDA should never approve ketamine and other hallucinogens for psychiatry’s use on patients, and legislators should prohibit clinics from establishing themselves in their respective states, essentially acting as legalized drug pushers. – Jan Eastgate, President CCHR International

Mind-altering prescription psychedelic can lead to addiction, health problems and death, yet ketamine clinics are a $3.1 billion industry in the U.S.

By Jan Eastgate
President CCHR International
October 27, 2023

On October 10, 2023, the Food and Drug Administration (FDA) issued a warning stating that ketamine, an anesthetic with hallucinogenic properties, lacks approval for the treatment of any psychiatric disorders. Despite this, compounded ketamine products (those having combined, mixed, or altered ingredients to make a medication) have been widely marketed for such termed “off-label.” The FDA has not verified the safety or efficacy of ketamine for such uses, raising concerns about abuse, misuse, psychiatric side effects, increased blood pressure, and respiratory depression.[1] The New York Times also reported that ketamine “can be addictive, and heavy, long-term use can lead to significant health problems, including irreversible urinary tract damage.”[2] CCHR says ketamine should never be approved for any so-called psychiatric disorder and states should act to prevent its off-label use.  

In the U.S., there are hundreds of unregulated infusion clinics, essentially where mainlining hallucinogenic drugs is done without any oversight. Ketamine is also obtained through telemedicine where it is dished out like “ketamine candy,” The Guardian reported in April this year.[3]

For the past 5 to 8 years, the drug has been injected for psychiatric conditions and pain management, with centers charging anywhere from $300 up to $2,000 a treatment.[4] For years, CCHR International has exposed the dangers of ketamine and these clinics, especially as ketamine is also abused and is known as a “date rape drug” because it causes disassociation in victims unwittingly drugged with it before being sexually assaulted. It can prevent them from realizing afterward that they have been raped.[5]

Ketamine Clinics are “Dealer’s Choice”

An international law firm has pointed out that, concerning the control and supervision of ketamine clinics, there is no regulation by the FDA. In this context, it appears to be a matter of “dealer’s choice” in determining how such businesses are conducted, which extends to establishing patient safety protocols. [6]

Nevertheless, this regulatory void has not deterred psychiatrists and profit-driven drug clinics from prescribing ketamine, despite the inherent risks. Positioned as a pain management alternative to opioids, a disconcerting revelation emerges: research presented at the 2019 American Society of Anesthesiologists conference indicates that more than one in three patients prescribed ketamine may encounter side effects, including hallucinations and visual disturbances. [7]

A study published in March 2023 in the American Journal of Drug Alcohol Abuse, said “the use of ketamine and/or its analogues [similarly structured products], as well as combinations with other drugs, can be fatal.” Researchers found 18 articles that described fatal cases and 16 overdoses. Poly-substance use was mentioned in 53% of the selected articles. A total of 312 overdose cases and 138 deaths were reported. In both death reports and overdose cases, ketamine was preponderant: 89.1% and 79%, respectively.[8]

By way of example, a patient receiving treatment at a Baton Rouge psychiatric hospital was found unresponsive in her room and later died from the effects of ketamine. Officials don’t know how she obtained and ingested the drug that killed her. The ketamine caused her brain to become deprived of oxygen, which in turn caused her death, the East Baton Rouge Coroner’s Office determined.[9]

Astoundingly, the researchers in the above study concluded, “Although clinicians must remain vigilant, this should not deter appropriate prescription” of ketamine.[10]

Ketamine vs. Prozac: An Equally Bad Choice

A similar narrative unfolded with the antidepressant Prozac (fluoxetine), where the unsettling side effects, including the potential for suicidal and hostile thoughts, were often ignored. It was purported, alongside other antidepressants, to possess the ability to attain an impressive “cure rate” of 90% in treating depression, supposedly by rectifying a chemical imbalance in the brain that led to depression. This supposed correction of a chemical imbalance has now been revealed as a marketing lie, according to a University of London study published last year.[11] The notion of a chemical imbalance in the brain was, in essence, a gigantic scam to sell antidepressants that don’t cure anything.

Refusing to admit antidepressants are useless, and, worse, harmful, psychiatrists and their pharma cohorts, blame the consumer for being “treatment resistant.” Some 30% of patients taking antidepressants are disingenuously described as having “treatment-resistant depression.”[12]

This justifies the use of even more intrusive drugs such as ketamine and psychedelic drugs—the latest “miracle” drugs promoted by psychiatrists because antidepressants have failed—and failure means less profits.

This opens the door to lucrative research. Consider one study where subjects were given a 96-hour infusion of ketamine as an alternative antidepressant. All 20 subjects also received clonidine, a blood pressure drug also used to treat ADHD and PTSD, to minimize the side effects of ketamine.[13]

Ketamine is a generic drug that is not owned by one person or company. Furthermore, many off-label uses of ketamine are facilitated through insurance coverage that seldom scrutinizes the associated risks.[14] 

Psychedelics: Another Failed Biomedical Paradigm

Ketamine and the push for psychedelics are further evidence of the ongoing failure of the “biomedical” model. This model places a heavy emphasis on the pharmacological treatment of mental disorders, despite global calls for its discontinuation. The October 2023 World Health Organization (WHO) and the United Nations Office of the High Commissioner for Human Rights (OHCHR) guidance on Mental Health, Human Rights, and Legislation, says the model “works to the detriment of other holistic and person-centered and rights-based approaches and strategies.” Further, “Legislation on mental health must therefore take a new direction away from the narrow traditional ‘biomedical paradigm’ that has contributed to coercive and confined environments in mental health services.”[15]

The FDA has no control over a drug it approves. It has approved ketamine only as an intravenous or intramuscular injection solution for induction and maintenance of general anesthesia. In 2019, the FDA approved a nasal spray, esketamine (SpravatoTM) for “treatment-resistant depression” in adults with acute suicidal ideation or behavior but only in conjunction with an oral antidepressant.[16] In other words, polypharmacy and a double hit of psychotropic, mind-altering drugs coursing through patients’ bodies. Researchers admit that how esketamine “works” as an antidepressant “is poorly understood.” Esketamine carries the FDA’s strongest black box warning for sedation, dissociation, abuse, and misuse, along with warnings for suicidal thoughts and behaviors in pediatric and young adult populations.[17]

In February 2022, the FDA alerted healthcare professionals of safety reports involving Spravato (esketamine) to treat psychiatric disorders which may be putting patients at risk of serious adverse events and potential misuse and abuse. Patients must be monitored inside a healthcare setting after administration for a minimum of two hours until patients are safe to leave.[18]

Since 2019, the use of Spravato has rapidly expanded with its manufacturer, Janssen Pharmaceuticals reporting an 82.4% increase in Spravato sales in Q1 of 2023 compared to Q1 of 2022.[19]

All other psychiatric uses of ketamine are unapproved and unregulated, though not illegal, The New York Times pointed out.[20]

Ketamine Clinics Flourish, Then Flop

From 2015 to 2018, the number of infusion clinics increased from 60 to 300.[21] Ketamine infusion clinics have fought for a slice of the estimated $3.1 billion market.[22] An investigation published by the medical news website STAT found wide-ranging inconsistencies among clinics, from the screening of patients to the dose and frequency of infusions to the coordination with patients’ mental health providers. STAT interviewed ketamine clinic owners, psychiatrists, and patients and reviewed online staff pages and screening protocols for dozens of ketamine clinics to gauge how patients are selected and treated. Among the findings: Clinics sometimes overhype the efficacy of ketamine, offer it for uses that haven’t been well-studied, and tout special blends that experts say aren’t supported by published evidence.[23]

In April 2023, The Guardian reported that “one of the largest startup clinic chains offering ketamine treatment has just gone bust, another is in dire straits, and others face uncertainty.” Ketamine Wellness Clinics (KWC), “one of the largest ketamine clinic chains in the US,” operating 13 sites out of nine states, abruptly closed in March 2023.[24]

ABC News reported another large chain called Field Trip Health and Wellness announced closures of their Chicago, Washington D.C., Seattle, San Diego, and Fredericton locations in 2023. Field Trip’s 13-session programs range from $5,250 to $6,750 and are not covered by insurance but may be eligible for partial insurance reimbursement, according to their website.[25]

Nick Nissen, a psychiatrist focused on psychedelics, who wrote the above ABC News article, and is a member of the ABC News Medical Unit, noted: “At-home ketamine treatment has come under scrutiny, with some patients obtaining prescriptions from multiple prescribers and developing an addiction to ketamine….”[26]

Ketamine is also unregulated in the telemedicine field with direct-to-door deliveries of the drug in “therapy packs,” which are dished out like “ketamine candy,” reported The Guardian. One provider offers 30 daily doses for $129 a month. They’re accompanied by Zoom calls with therapists, playlists, guided meditations, educational information and eyeshades, meaning people do not even have to leave their homes. “In a choice between expensive in-person ketamine assisted therapy, and cheap ketamine candy sent straight to your home, many unsurprisingly chose the latter.”[27]

Ketamine is a structural analog of the recreational drug phencyclidine (PCP), making it popular as an illicit recreational drug, which goes by the street names “K,” “vitamin K,” “super K,” “special K,” “super C,” “special LA coke,” “jet,” “superacid,” and “green”. Ketamine toxicity can cause a variety of neurological, cardiovascular, psychiatric, urogenital (urinary and genital), and abdominal symptoms.[28] It is also a horse tranquilizer.[29]

According to the research published in 2023 in JAMA Psychiatry, U.S. law enforcement agencies seized more than 1,500 pounds of ketamine in 2022—about 12 times more than in 2017.[30] A parallel is that when LSD was first used on the psychiatrist’s couch in the early 1950s, it was widely touted to be “the next big thing” in psychiatry, which could supersede electroshock therapy and psychosurgery. It went from there to the streets in 1963 in the form of a liquid soaked onto sugar cubes.[31] By 2010, there were approximately 32 million lifetime psychedelic users in the U.S., according to a 2013 study.[32] From 2015 to 2018, the rate of “turning on and tuning in” with LSD, to paraphrase Harvard psychologist Timothy Leary, increased by more than 50% in the U.S. The rise was especially pronounced in certain user groups, including people with college degrees (70% increase), those aged 26 to 34 (59%), and 35 to 49 (223%).[33]

Damaging hallucinogens, psychiatric hype about the drugs’ touted “benefits” for “treatment resistance,” as well as for-profit mind-altering treatment centers is but another vector in mind-altering culture that psychiatrists have steered society into with antidepressants, antipsychotics, sedatives, stimulants, and other unworkable biomedical “solutions”.  

To reiterate, the FDA should never approve ketamine and other hallucinogens for psychiatry’s use on patients, and legislators should prohibit clinics from establishing themselves in their respective states, essentially acting as legalized drug pushers. The Drug Enforcement Administration should clamp down on internet sales of the drug, and insurance companies should not reimburse any off-label use.


References:

[1] “FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders,” FDA, 10 Oct. 2023, https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine; hallucinogenic ref “Ketamine clinics for mental health are popping up across the U.S. Does the treatment work?” NBC News, 4 Jan. 2023, https://www.nbcnews.com/health/mental-health/ketamine-clinics-mental-health-are-popping-us-treatment-work-rcna63522

[2] “FDA Issues Warning Over Misuse of Ketamine,” The New York Times, 11 Oct. 2023, https://www.nytimes.com/2023/10/11/health/fda-ketamine-warning.html

[3] “Ketamine clinics have emerged across the US. They’re already going bust,” The Guardian, 11 Apr. 2023, https://www.theguardian.com/society/2023/apr/11/ketamine-clinics-us-business-safety-mental-health

[4] https://www.cchrint.org/2022/04/07/psychiatrys-future-legalized-psychedelic-drug-mainlining-clinics/; https://ketamineclinicsdirectory.com/; “Ketamine clinics have emerged across the US. They’re already going bust,” The Guardian, 11 Apr. 2023, https://www.theguardian.com/society/2023/apr/11/ketamine-clinics-us-business-safety-mental-health; https://abcnews.go.com/Health/closures-ketamine-clinics-leave-patients-scrambling-treatment/story?id=99800266

[5] https://www.cchrint.org/2019/06/26/cchr-warns-about-antidepressant-nasal-spray-esketamine-spravato-use-on-veterans/, citing https://www.medicalnewstoday.com/articles/320409#types

[6] https://www.cchrint.org/2022/04/07/psychiatrys-future-legalized-psychedelic-drug-mainlining-clinics/, citing https://harrisbricken.com/cannalawblog/the-ketamine-clinic-craze-legalities-and-possibilities/

[7] https://www.asahq.org/about-asa/newsroom/news-releases/2019/10/9-ketamine-side-effects

[8] Tharcila V Chaves, et al., “Overdoses and deaths related to the use of ketamine and its analogues: a systematic review,” American Journal of Drug Alcohol Abuse, Mar. 2023, https://pubmed.ncbi.nlm.nih.gov/36410032 /

[9] https://www.theadvocate.com/baton_rouge/news/crime_police/after-drug-induced-death-at-baton-rouge-psychiatric-hospital-womans-family-seeks-answers/article_2d4ace34-ca98-11e9-861f-d7cf1bfe860d.html

[10] Tharcila V Chaves, et al., “Overdoses and deaths related to the use of ketamine and its analogues: a systematic review,” American Journal of Drug Alcohol Abuse, Mar. 2023, https://pubmed.ncbi.nlm.nih.gov/36410032/ 

[11] https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00430-7/fulltext; chemical imbalance lie, https://www.cchrint.org/2022/07/22/cchr-lauds-study-disproving-chemical-imbalance-causes-depression/ citing https://www.nature.com/articles/s41380-022-01661-0; https://medlineplus.gov/druginfo/meds/a689006.html#:~:text=swelling%20of%20the%20face%2C%20throat,%2C%20nausea%2C%20vomiting%2C%20or%20diarrhea

[12] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6534172/

[13] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4905687/; https://www.ncbi.nlm.nih.gov/books/NBK531717/

[14] https://www.lonestarinfusion.com/blog/ketamine-fda-approval

[15] https://www.cchrint.org/2023/09/18/who-guideline-condemns-coercive-psychiatric-practices/ citing World Health Organization, OHCHR, “Guidance on Mental Health, Human Rights and Legislation,” 9 Oct. 2023, pp. xvi and 9

[16] Op. cit., “FDA warns patients and health care providers about potential risks associated with compounded ketamine products….” FDA

[17] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6534172/

[18] https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-professionals-potential-risks-associated-compounded-ketamine-nasal-spray

[19] Dr. Nicholas Nissen, “Closures of ketamine clinics leave some patients scrambling for treatment,” ABC News, 3 June 2023, https://abcnews.go.com/Health/closures-ketamine-clinics-leave-patients-scrambling-treatment/story?id=99800266

[20] Mariah Taylor, “FDA warns providers against ketamine for psychiatric disorders,” Beckers, 10 Oct. 2023, https://www.beckershospitalreview.com/patient-safety-outcomes/fda-warns-providers-against-ketamine-for-psychiatric-disorders.html

[21] https://www.cchrint.org/2022/04/07/psychiatrys-future-legalized-psychedelic-drug-mainlining-clinics/ citing https://harrisbricken.com/cannalawblog/the-ketamine-clinic-craze-legalities-and-possibilities/

[22] https://www.grandviewresearch.com/industry-analysis/us-ketamine-clinics-market-report

[23] 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/

[24] “Ketamine clinics have emerged across the US. They’re already going bust,” The Guardian, 11 Apr. 2023, https://www.theguardian.com/society/2023/apr/11/ketamine-clinics-us-business-safety-mental-health; https://abcnews.go.com/Health/closures-ketamine-clinics-leave-patients-scrambling-treatment/story?id=99800266

[25] Dr. Nicholas Nissen, “Closures of ketamine clinics leave some patients scrambling for treatment,” ABC News, 3 June 2023, https://abcnews.go.com/Health/closures-ketamine-clinics-leave-patients-scrambling-treatment/story?id=99800266

[26] Ibid.

[27] Op Cit., “Ketamine clinics have emerged across the US. They’re already going bust,” The Guardian

[28] Vwaire J. Orhurhu, et al., “Ketamine Toxicity,” National Library of Medicine, 30 Jan. 2023, https://www.ncbi.nlm.nih.gov/books/NBK541087/

[29] https://psychedelic.support/resources/ketamine-treatment-guide-for-mental-health/

[30] Deidre McPhillips, “Illicit ketamine on the rise in the US, research suggests,” CNN Health, 24 May 2023, https://www.cnn.com/2023/05/24/health/illicit-ketamine-rise-in-us/index.html

[31] Mo Costandi, “A brief history of psychedelic psychiatry,” The Guardian, 2 Sept. 2014, https://www.theguardian.com/science/neurophilosophy/2014/sep/02/psychedelic-psychiatry

[32] Teri S. Krebs, et. al., “Over 30 million psychedelic users in the United States,” F1000Res. 2013, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3917651/ 

[33] Rachel Nuwer, “Americans Increase LSD Use—and a Bleak Outlook for the World May Be to Blame,” Scientific American, 10 Jul. 2020, https://www.scientificamerican.com/article/americans-increase-lsd-use-and-a-bleak-outlook-for-the-world-may-be-to-blame1/