November 27, 2023 – On a drizzly Wednesday afternoon, Christopher sat in a padded recliner after his final infusion on the Ketamine Healing Clinic in Los Angeles, relaxing with a comfortable blanket over him. Christopher (not his real name) was diagnosed with depression on the age of 19. He is now 35 years old and is struggling to beat depression that has now turn out to be treatment-resistant.
He listed the traditional and alternative treatments he had tried: Lithium. Wellbutrin. Paxil. Other antidepressants. Mushrooms. Meditation. Cognitive behavioral therapy.
Nothing provided lasting relief and he felt that some medications dulled his feelings. “I became more robotic, less social,” he said.
Ketamine, he said, is different. He has found some relief, some self-acceptance, and is far less hard on himself. He is finding it easier to exercise and be social, two really useful strategies for relieving depression.
The cost of the treatments (here, $700 for a single session), that are used off-label and typically not covered by insurance, are price it, he said. And significantly better, he said, than an alternative choice — ordering ketamine for home use through 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 turn out to be increasingly common but in addition more controversial within the United States. No one knows exactly what number of clinics just like the one Christopher visits are in operation, but experts put the number at around 700 to 800. The variety of patients with a ketamine prescription increased by greater than fivefold from 2017 to 2022. Online access to ketamine via telemedicine has increased because the start of the pandemic, when the Drug Enforcement Administration relaxed restrictions on prescribing Schedule III controlled substances reminiscent of ketamine via telemedicine. Now this flexibility has been expanded until 2024.
Meanwhile, the FDA has issued a warning about compounded ketamine, researchers have discovered widespread deceptive promoting practices on telemedicine platforms that supply it, and doctors who prescribe it or support its use are struggling to search out ways to get out of a largely unregulated system to search out your way around.
It has turn out to be, as many say, a Wild West that should be tamed, regulated, monitored and maybe even registered.
The query nobody can answer is: How does it work?
FDA and DEA raise concerns about ketamine
Ketamine is a Schedule III controlled substance approved by the FDA just for general anesthesia and never for psychiatric disorders. The DEA notes ketamine's potential for abuse and addiction and that it’s used as a celebration or club drug, where it’s often known as K or Super K, amongst other names.
In 2019, the FDA approved the shape of ketamine often known as esketamine, the nasal spray Spravato, to treat treatment-resistant depression. However, it is just available at an authorized doctor's office or clinic. Additionally, in keeping with the DEA and FDA, the one accepted medical uses of ketamine are short-term sedation and anesthesia.
In an Oct. 10 FDA warning, The agency warned of potential risks of ketamine, including oral dosage forms, for the treatment of psychiatric disorders. The release emphasized that ketamine will not be approved by the FDA to treat psychiatric disorders. It warns of safety concerns reminiscent of misuse, misuse, increase in blood pressure, respiratory depression and other problems. The statement said: “We are not aware of any evidence to suggest that it is safer, more effective, or more rapid-acting than medications approved by the FDA for the treatment of specific psychiatric disorders.”
Prescribers: Ketamine Works
While ketamine is usually promoted off-label to treat depression, it is usually utilized in clinics for anxiety, post-traumatic stress disorder (PTSD), binge eating, and addiction. Protocols vary, but one example is six infusions over three weeks, often accompanied by music; sometimes with integrated talk therapy.
Costs also vary, with a single session often costing $700 or $800 in metropolitan areas and sometimes as much as $2,500. Insurance coverage is rare to non-existent, but some patients have submitted detailed bills to their plans and received reimbursement. And some clinics offer payment programs. The costs at home also vary. Mindbloom, a telehealth program that gives ketamine tablets, charges $193 per session for a package of six tablets and offers medical advice and advice. Joyous, one other program, costs $129 per 30 days.
Doctors and other health care providers who run ketamine clinics imagine within the treatment's advantages when administered to the correct patients after a comprehensive psychiatric and medical evaluation.
Giving ketamine helps “trigger a neuroplastic process in the brain,” said Steven Radowitz, MD, an internal medicine physician who’s co-founder and chief medical officer of Nushama Psychedelic Wellness Center in New York City. The treatment helps patients “process and redefine the way they view their lives.”
“It allows the brain to work more freely [way],” he said. Many patients with depression and other problems have had a history of trauma, such as growing up with an alcoholic parent, which is often retriggered. With ketamine, he said, the memory of the trauma is not erased, but the memory is A patient's reaction to this can change.
“Ketamine works on the brain in an organic way and increases the brain's ability to function,” said David Mahjoubi, MD, an anesthesiologist who founded the Ketamine Healing Clinic in Los Angeles, where Christopher is treated. Among other effects, ketamine can strengthen the connections between neurons, which other experts have also found discussed.
When treating depression, Mahjoubi observes increased motivation and decreased apathy. Patients receiving depression medications from other providers can continue to take them. After administering infusions at his clinic, he sometimes also writes prescriptions for home use of tablets or generic sprays. Some patients use ketamine and talk therapy in combination.
He hopes state medical boards and the FDA will work together to set standards for how clinics operate and regulate which health care providers must be present during an infusion.
“IV ketamine works very well in the right patients who are screened and examined,” said Dr. Katharine Grace Marder, a psychiatrist and physician assistant at UC Davis Health System. She previously worked at a ketamine clinic. She has observed that ketamine helps patients who haven’t experienced relief from multiple antidepressants. “It’s so gratifying to be able to give them their lives back.”
Until further research is accomplished, she recommends limiting off-label use of ketamine to major depressive disorder and possibly bipolar disorder. “I do not recommend using ketamine in any form at home. There is not enough evidence to show that the benefits of home use outweigh the risks.”
Ketamine research
Ketamine proved comparable to electroconvulsive therapy (ECT) for treatment-resistant major depression, researchers reported in May New England Journal of Medicine. While 55.4% of the 195 patients in the ketamine group had a response, this was the case in 41.2% of the 170 ECT patients.
Another Study, Supported by Mindbloom, home oral ketamine was found to be safe and effective for moderate to severe anxiety and depression in 1,247 people who completed treatment. More than 62% reported an improvement in their depression and anxiety by 50% or more.
Problems with online advertising
The direct-to-consumer advertising of ketamine has numerous misleading claims Researchers from Johns Hopkins University and the University of Colorado found out about the safety and effectiveness of the treatment. Researchers identified clinics in Maryland with an online site and found 17 advertisers operating in 26 locations.
Many claims about treatment are misleading, said Michael J. DiStefano, PhD, assistant professor of clinical pharmacy at the University of Colorado Anschutz Medical Campus in Aurora and co-author of the study. “We found one instance of a simple false statement that ketamine was approved by the FDA to treat depression,” DiStefano said. He hopes to expand the research nationwide.
Patient testimonials
Those who have tried ketamine report mixed results. A former ketamine user concluded that the therapy recommended by his then-psychiatrist was not effective in his diagnosis of PTSD. “I did a total of three ketamine sessions and infusions,” said the 30-year-old Southern California resident, who asked that his name not be used. “The first two were positive, but the third was not and I had to spend some time in hospital after that.”
He is doing better with a new therapist and concluded that research on ketamine for post-traumatic stress disorder is not yet conclusive.
Jessa Common, 35, was diagnosed with post-traumatic stress disorder after watching as a spectator at the finish line of the 2013 Boston Marathon bombing. She went to talk therapy to recover, but it wasn't enough. “I chose ketamine because I didn’t want to feel like groundhog every spring,” she said. Spring, she said, unsettled her every year as memories of sirens and helicopters came flooding back.
While Common said it was hard to describe the effect, “I might say what ketamine did for me is that I used to be capable of see myself, my life and my traumas as a part of a much, much greater story.” made her feel spiritually connected.
She dropped out of a prestigious medical degree and left her job at a renowned New York restaurant to work at one other, less prestigious restaurant. “I look less impressive on paper, but I’m much happier.”