Nov. 27, 2023 — On a drizzly Wednesday afternoon, Christopher sat in an overstuffed reclining chair, relaxing with a cozy blanket draped across him after his most recent infusion at the Ketamine Healing Clinic of Los Angeles. Diagnosed with depression at age 19, Christopher (not his real name), now a 35-year-old graduate student, has struggled to overcome what is now treatment-resistant depression.
He ticked off the treatments, conventional and alternative, that he’s tried: Lithium. Wellbutrin. Paxil. Other antidepressants. Mushrooms. Meditation. Cognitive behavioral therapy.
Nothing provided long-term relief, and he felt some medications blunted his emotions. “I became more robotic, less social,” he said.
Ketamine, he said, is different. He’s found some relief, some self-acceptance, and is much less hard on himself. He’s finding it easier to exercise and be social, two recommended strategies to ease depression.
The expense of the treatments ($700 for a single session here), used off-label and typically not covered by insurance, is worth it, he said. And much better, he said, than another option — ordering ketamine for use at home via a telehealth platform. No thanks, he said. “You don’t know where it comes from.”
More Popular but Controversial
In recent years, ketamine and access to it have become more common but also more controversial in the U.S. No one knows exactly how many clinics like the one Christopher goes to are in operation, but experts believe the number is around 700 to 800. . The number of patients with a ketamine prescription rose more than fivefold from 2017 to 2022. Online access to ketamine via telemedicine has grown ever since the beginning of the pandemic, when the Drug Enforcement Administration loosened restrictions for prescribing Schedule III controlled substances such as ketamine via telemedicine. Now that flexibility has been extended through 2024.
Meanwhile, the FDA has issued a warning about compounded ketamine, researchers have found widespread deceptive advertising practices on telemedicine platforms that offer it, and doctors who prescribe it or support its use are struggling to find ways to navigate a system that’s largely unregulated.
It has become, many say, a Wild West that needs taming, regulation, oversight, and perhaps even a registry.
The question no one knows how to answer is: How to do that?
FDA, DEA Voice Ketamine Concerns
Ketamine is a Schedule III controlled substance that’s FDA approved only for general anesthesia, not for any psychiatric disorder. The DEA notes ketamine’s potential for abuse and potential for addiction and that it is used a party or club drug, where it is known as K or Super K, among other names.
In 2019, the FDA approved the form of ketamine known as esketamine, the nasal spray Spravato, for treatment-resistant depression. But it is only available from a certified doctor’s office or clinic. Beyond that, the only accepted medical uses of ketamine, in the eyes of the DEA and FDA, are short-term sedation and anesthesia.
In an Oct. 10 FDA warning, the agency warned of potential risks of ketamine, including oral formulations, for psychiatric disorder treatments. The message emphasized that ketamine is not FDA approved for treating any psychiatric disorder. It warns of safety concerns, such as abuse, misuse, blood pressure elevations, respiratory depression, and other issues. The statement said that “we are not aware of evidence to suggests that it is safer, is more effective, or works faster than medications that are FDA approved for the treatment of certain psychiatric disorders.”
Prescribers: Ketamine Works
While ketamine is often promoted, off-label, for depression treatment, it’s also used at clinics for anxiety, posttraumatic stress disorder (PTSD), binge eating, and addiction. Protocols vary, but one example is six infusions over 3 weeks, often accompanied by music; sometimes with talk therapy incorporated.
Costs vary as well, with a single session in metropolitan areas often costing $700 or $800 and sometimes up to $2,500. Insurance coverage is rare to nonexistent, but some patients have submitted detailed bills to their plans and gotten reimbursement. And some clinics offer payment programs. At-home costs vary, too. Mindbloom, a telehealth program that offers ketamine tablets, charges $193 a session for a package of six and provides clinician input and guidance. Joyous, another program, is $129 a month.
Doctors and other health care providers managing ketamine clinics are convinced of the treatment’s worth if it is given to the right patients after a full psychiatric and medical evaluation.
The dosing of ketamine helps to “create a neuroplastic process in the brain,” said Steven Radowitz, MD, an internal medicine doctor who is co-founder and chief medical officer at Nushama Psychedelic Wellness Center in New York City. The treatment helps patients “process and reframe how they see their lives.”
“It allows the brain to work in a more free flow [way],” he said. Many patients with depression and other issues have had some past trauma, such as growing up with an alcoholic parent, that often gets retriggered. With ketamine, he said, the memory of the trauma isn’t taken away, but a patient’s response to it can change.
“Ketamine works organically on the brain to increase the functional capacity of the brain,” said David Mahjoubi, MD, an anesthesiologist who founded the Ketamine Healing Clinic of Los Angeles, where Christopher is treated. Among other effects, he said, ketamine can increase connections between neurons, which other experts have also discussed.
When given for depression, Mahjoubi observes increased motivation and decreased apathy. Patients on medication for depression given by other providers can remain on them. After giving infusions in his clinic, he sometimes also writes prescriptions for home use of tablets or generic spray. Some patients use ketamine and talk therapy in combination.
His hope is that state medical boards and the FDA work together to set up standards for running the clinics and regulating which health care providers must be present during an infusion.
“IV ketamine works very well for the right patients, who are evaluated and screened,” said Katharine Grace Marder, MD, a psychiatrist and associate physician at UC Davis Health System. She previously worked at a clinic providing ketamine. She’s observed ketamine helping patients who haven’t gotten relief from several antidepressants. “It’s so gratifying that you can give them their life back.”
Until further research is done, she recommends restricting ketamine’s off label use to major depressive disorder and potentially bipolar disorder. “I don’t recommend the home use of ketamine, in any formulation. There’s not enough evidence that the benefit of home use outweighs the risk.”
Ketamine was found comparable to electroconvulsive therapy (ECT) for treatment-resistant major depression, researchers reported in May in the New England Journal of Medicine. While 55.4% of the 195 patients in the ketamine group had a response, 41.2% of the 170 ECT patients did.
Another study, supported by the company Mindbloom, found at-home, oral ketamine safe and effective for moderate to severe anxiety and depression in 1,247 people who completed treatment. More than 62% reported a 50% or greater improvement for depression and anxiety.
Issues With Online Advertising
Direct-to-consumer advertising of ketamine has numerous misleading claims about the safety and efficacy of the treatment, researchers from Johns Hopkins University and the University of Colorado found. The researchers identified Maryland clinics with an online site, finding 17 advertisers operating across 26 locations.
Many statements about the treatment were misleading, said Michael J. DiStefano, PhD, assistant professor of clinical pharmacy at the University of Colorado Anschutz Medical Campus, Aurora and a study co-author. “We found one case of a straight-up, false statement, saying that ketamine is FDA-approved to treat depression,” DiStefano said. He hopes to expand the research nationally.
Those who have tried ketamine report mixed results. One former ketamine user decided the therapy, recommended by his psychiatrist at the time, was not effective for his diagnosis of PTSD. “I did a total of three ketamine sessions, infusions,” said the 30-something Southern California resident, who asked that he not be named. “The first two were positive, but the third was not, and I had to spent time hospitalized after it.”
He’s doing better with a new therapist and decided the research on ketamine for PTSD is not definitive yet.
Jessa Common, 35, diagnosed with PTSD after being a spectator at the finish line of the 2013 Boston Marathon bombing, went to talk therapy to help herself recover, but it wasn’t enough. “I sought out ketamine because I didn’t want every year to feel like Groundhog Day around spring,” she said. Spring, she said, threw her for a loop every year, as the memory of sirens and helicopters flooded back.
While Common said it’s hard to describe the effect, “I would say what ketamine did for me is allow me to see myself and my life and traumas as part of a much, much larger story,” giving her a spiritually connected feeling.
She dropped out of a prestigious pre-med program and gave up her job at a prestigious New York restaurant, now working at another, less prestigious one. “I look less impressive on paper, but I’m so much happier.”
Source : WebMD