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In late 2022, Sara Gutila's treatment-resistant depression became so severe that she was actively considering suicide. The 34-year-old, who grew up in an orphanage, suffered physical violence, sexual abuse and drug use during her childhood, leaving her with psychological scars that threatened her life.
In desperation, her husband scraped together $600 to pay for the first of six intravenous ketamine treatments at Ketamine Clinic Los Angeles, which administers the generic anesthetic for off-label uses such as treating depression. Ta. When Gutira took an Uber to travel the 75 miles to Los Angeles, it was her first time in two years that she had left her home in Llano, California. She says the results were immediate.
“The relief I felt after my first treatment made me wonder what 'normal' feels like,” she says. “I have never felt so okay and so peaceful.”
For-profit ketamine clinics have proliferated in recent years, offering IV treatment for a variety of mental health issues, including obsessive-compulsive disorder, depression, and anxiety. Off-label use of ketamine hydrochloride, a Schedule III drug approved as an anesthetic by the Food and Drug Administration in 1970, was considered radical just a decade ago, but now there are between 500 and 750 cases nationwide. Ketamine clinics are opening.
Market analysis firm Grand View Research projects industry revenue of $3.1 billion in 2022, more than doubling to $6.9 billion by 2030. Most insurance policies do not cover ketamine for mental health, so patients must pay out-of-pocket.
Off-label use
Although it is legal for doctors to prescribe ketamine, the FDA has not approved it as a mental health treatment, leaving individual practitioners to develop their own treatment protocols. Results vary widely among health care providers, with some favoring progressively lower doses of treatment and others favoring higher doses, where the drug can cause hallucinations at the right doses.
“Ketamine is the Wild West,” says Dustin Robinson, managing principal at Iter Investments, a venture capital firm that specializes in psychedelic drug treatments.
Ketamine practitioners stress that the drug's emergence as a mental health treatment was driven by a dire need. According to the National Institute of Mental Health, depression is the leading cause of disability among people ages 15 to 44 in the United States, with approximately 25% of adults experiencing a diagnosable mental disorder each year.
Meanwhile, many insurance plans cover mental health services at lower rates than physical care, despite legal equality requirements. As a result, many patients with mental illnesses receive little initial care and are hopeless by the time they arrive at a ketamine clinic, said Dr. says Dr. Steven Siegel. .
Matthew Perry and Elon Musk
However, the revelation friend The death of star Matthew Perry from a ketamine overdose and billionaire Elon Musk's public use of ketamine have brought renewed attention to ketamine and its regulatory environment, or lack thereof. are gathering.
Private ketamine clinics often offer same-day appointments and allow patients to pay out-of-pocket for the drug, which provides immediate results. Ketamine is administered intravenously, and patients are often given blankets, headphones, and eye masks to enhance the dissociative feeling of not being in their own body. A typical dose of ketamine to treat depression is one-tenth of the dose used in anesthesia and costs about $1 in the clinic, but in the clinic it costs $600 to $1,000 per treatment. It costs.
Ketamine still suffers from its reputation as a party drug known as “Special K.” Siegel's first grant from the National Institutes of Health was to study ketamine as a drug of abuse. It can send users down a “K-hole” (also known as a bad trip) and can induce psychosis. Studies in animals and recreational users have shown that chronic drug use impairs both short- and long-term cognition.
Perry drowned in October, raising alarm after initial toxicology tests attributed his death to the acute effects of ketamine. A December report said Perry had been receiving IV therapy a week before her death, but that it was the high dose of the substance she ingested on the day of her death, along with opioids and sedatives, that caused her fatal injuries. It was revealed that medical ketamine was not to blame.
various protocols
Sam Mandel co-founded Ketamine Clinic Los Angeles in 2014 with his father, Stephen Mandel, an anesthesiologist with a background in clinical psychology, and Sam Mandel said the clinic has established its own protocols. He said he is doing so. This includes monitoring patients' vital signs during treatment and having a psychiatrist or other mental health professional on hand to ensure safety. Initial treatment starts with a low dose and increases if no effect is achieved.
While many clinics follow the Mandels' step-by-step approach, the dosing protocol at MY Self Wellness, a ketamine clinic in Bonita Springs, Florida, is aimed at inducing a psychedelic episode.
Christina Thomas, president of MY Self Wellness, says she based her clinic's protocols on a list of “don'ts” based on bad experiences reported at other clinics. .
Ricardo Ramirez Buxeda/Orlando Sentinel/Tribune News Service (via Getty Images)
This field is not completely unregulated. State medical boards and boards of nursing oversee doctors and nurses, and the FDA and Drug Enforcement Administration regulate ketamine. However, most anesthesiologists have no knowledge of mental health, and psychiatrists do not know much about anesthesia, Sam Mandel points out. He said a collaborative, multidisciplinary approach is needed to develop standards across the field, especially since ketamine can affect vital signs such as blood pressure and breathing.
The protocol governing Spravato, an FDA-approved drug based on a close chemical relative of ketamine called esketamine, is illustrative. Because of the potential for serious side effects, it is subject to the FDA's Risk Evaluation and Mitigation Strategies (REMS) program, which has additional requirements, said Iter Investments' Robinson. Spravato's REMS requires him to be monitored for two hours after each dose and prohibits patients from driving on treatment days.
In contrast, generic ketamine has no REMS requirements. And because it's generic, cheap, and already on the market, drug companies have little financial incentive to conduct the expensive clinical trials required for FDA approval for certain mental illnesses.
This means it is up to the patient to evaluate their ketamine provider. Clinics that specialize in intravenous infusions, rather than offering the treatment as an add-on, may be more familiar with the nuances of administering the drug. Ideally, the practitioner should have expertise in mental health and anesthesia, or have multiple specialties under the same roof, and the clinic is equipped with hospital-grade monitoring equipment. Mandel says there is a need.
Siegel, a professor at the University of Southern California who has been researching ketamine since 2003, says the drug is particularly useful as an emergency intervention, giving traditional treatments such as talk therapy and SSRI antidepressants enough time to take effect. He said that it can reduce suicidal thoughts for a long time.
“The solutions we've had so far have failed,” Mandel said.
The drug is now popular enough as a mental health treatment that its name appears on 26 “Adopt A Highway” signs along Highways 405 and 10, and that Mandel's clinic's name appears on thousands of It's a daily sight for many Angelenos.
And a psychedelic renaissance in mental health is accelerating. A drug containing MDMA, known as ecstasy or Molly, is expected to receive FDA approval in 2024. A drug containing psilocybin, the active ingredient in magic mushrooms, could be released as early as 2027, and a stroke treatment containing the active ingredient could also be released in the same year. DMT, a hallucinogen, is expected to appear.
Iter Investments' Robinson says many ketamine clinics are opening in anticipation of the psychedelic market's expansion. Because these new drugs are more likely to be covered by insurance, Robinson advises clinics to offer FDA-approved treatments such as Spravat so they can have the appropriate insurance infrastructure and staff in place.
For now, Sara Gutila plans to pay for her ketamine treatment out of pocket. A year after her first infusion, she and her husband are saving up for her second infusion. In the meantime, she rescues dogs and horses on her ranch in Llano and relies on telehealth therapy and psychiatric medication to get by.
The IV is not a “magic solution,” but it is a tool to help keep her moving in the right direction.
“Before, there was no light at the end of the tunnel,” she says. “Ketamine literally saved my life.”
This article was created by KFF Health News, a national newsroom that produces in-depth journalism about health issues. KFF Health News is california healthlinean editorially independent service. california healthcare foundation.