As most people know by now, ketamine clinics are prevalent in the United States. These clinics offer ketamine as a treatment for a variety of disorders, including pain relief, behavioral health disorders, opiate addiction, and many other ailments. Unfortunately, there are not many studies that demonstrate whether ketamine is efficacious for these various ailments because, to my knowledge, there are no randomized double-blinded clinical trials for off-label use of ketamine. Because ketamine is an FDA-approved drug, physicians and other appropriately trained healthcare providers can prescribe ketamine for off-label uses. Ketamine was approved by the FDA approximately 60 years ago for use as a general anesthetic. It is not FDA-approved for any other condition.
A few years ago, the FDA approved Esketamine (sold under the name Spravato), which is a nasal spray. Esketamine is approved by the FDA for treatment-resistant depression but with strict controls about how it can be used. In addition to the foregoing, compound pharmacies are now creating their formulations of ketamine – whether it is a lozenge, sublingual tablet, or another form. The FDA has issued two warnings about the use of compounded ketamine, which I wrote about recently. See: A Closer Look at the FDA Warnings on Compounded Ketamine.
In a recent article published by the Yale School of Medicine (“YSM”), the author discusses some of the various issues with the use of ketamine for treating various disorders. The author echoes many of the concerns I have written about before. See: Ketamine Clinics and Malpractice: Recent New York Litigation.
One passage of the YSM article is instructive:
There are two other risks that are a little bit more complicated. One is related to the real care of people with serious mental illness. Ketamine is not a miracle cure. This is not a treatment to be given in isolation. All of the studies presented for consideration of FDA-approval were done with very close psychiatric follow up. It is incredibly naïve and uninformed to think ketamine alone will make your depression go away. It’s a part of a treatment plan, not the treatment plan. It should be given as part of an overall treatment plan with a mental health professional. In fact, the FDA approval for ketamine also states that it has to be used along with an oral anti-depressant. It’s not even approved to be used alone. These ketamine clinics that provide the treatment without close follow-up of some type being provided by a mental health professional, in my mind, are a very dangerous thing, because they aren’t providing the comprehensive mental health care that these patients need.
This is particularly prescient for those providers who own and/or work for a ketamine clinic (or a telehealth clinic that prescribes ketamine). While the author focuses on the risks to patients, the same concerns are prevalent for providers. Even though any physician with a DEA license can order ketamine and start an IV, that does not mean that any physician is qualified to treat behavioral health disorders. Providers who are not properly trained and who are the sole source of behavioral health treatments assume tremendous risk.
This is why I have always advocated for a holistic approach to treating behavioral health disorders. Any ketamine provider should either (1) be trained in behavioral health issues, and/or (2) if they are not trained in this area, they should ensure that the patient is receiving the full panoply of behavioral health treatments. As the author of the YSM article points out, this would include seeing a behavioral health professional (in addition to receiving ketamine treatments). Alternatively, a provider should only see patients at a ketamine clinic when they have been referred by a behavioral healthcare provider who is overseeing their care. The author also correctly notes that any patient needs a treatment plan – and that treatment plan should be shared with all providers.
The author went on to note:
This idea of having ketamine clinics that stand alone are something that we must think really carefully about. This is because they’re not seeing patients and deciding what the best treatment is—they only have one treatment. They don’t provide comprehensive care. As I said before, this is not a treatment in and of itself. It’s part of the whole treatment plan. Let’s say somebody has diabetes and I have an insulin clinic. I’m going to give you insulin, but I’m not going to take care of any other part of your diabetes. We’re not going to talk about diet or lifestyle changes. We’re not going to talk about anything else. I’m just going to give you the insulin. That’s the real danger with ketamine clinics. If a patient has a crisis at two in the morning, they don’t have a way to contact a mental health professional. This is my biggest concern about ketamine treatment: It is critical for it to be a part of a comprehensive mental health plan, not in isolation.
The hypothetical about insulin drives the point home about the proper use of ketamine. Like any other disorder, a treatment plan is necessary. The notion of “one-stop shopping” for treating an ailment is a very dangerous precedent that can have cataclysmic results for the patient and the providers.
While psychedelic treatments hold a lot of promise for treating behavioral health disorders, they must be used carefully and in conjunction with a full treatment team. Otherwise, the results can lead to severe outcomes for everyone involved in the patient’s care.
