Ketamine is being used to treat people with severe depression, but some question the legality and ethics of such practice. The FDA approved ketamine for use as an anesthetic. However, the drug has become popular in the nightclub scene where it is known as “Special K” or just “K.”
According to the Foundation for a Drug-Free World, ketamine is classified as a “dissociative anesthetic.”
Meaning “that [it] distorts perception of sight and sound and produces feelings of detachment (dissociation) from the environment and self.”
In typical doses, it can cause hallucinations, which is why another street name for it is “Super Acid.” Even modest amounts of the drug can have various adverse side effects such as nausea, vomiting, numbness, depression, amnesia, and even respiratory failure.
Larger doses present more risks, but also cause the user to experience what is known as “K-Hole.” This effect is a dissociation so profound that it is like an “out of body or near-death experience.” However, the drug has found another use outside of anesthesia and dangerous recreational use.
According to NPR, “Gerard Sanacora, a professor of psychiatry at Yale University, has treated hundreds of severely depressed patients with low doses of ketamine.”
— Elina Shatkin (@elinashatkin) February 3, 2016
A physician using a drug for something other than its FDA-approved purpose is not illegal. The practice is referred to as “off-label prescribing,” and it is a relatively common practice, according to Psychiatric Times.
One study has shown that “40% to 60% of prescriptions are for off-label use.”
If so many drugs are already prescribed off-label, why is ketamine of such concern?
Dr. Sanacora told NPR that colleagues have asked him how he could be prescribing patients ketamine when so little is known about its long-term effects.
“If you have patients that are likely to seriously injure themselves or kill themselves within a short period of time, and they’ve tried the standard treatments, how do you not offer this treatment?”
Sanacora and others feel that if the treatment can save a life, there is nothing unethical about prescribing the drug. More than 3,000 patients in Canada and the U.S. have been successfully treated with ketamine. However, even Sanacora is not without concerns regarding prolonged exposure to the drug.
— Sober_Recovery (@Sober_Recovery) May 21, 2016
According to Time, the American Psychiatric Association (APA) formed a task force to study the use of ketamine as a clinical antidepressant, and Dr. Sanacora was part of that team. In a report published in JAMA Psychiatry, the APA task force determined that while ketamine has shown to be effective for short-term use, the data for the long-term efficacy is just not there.
“The evidence that we have to date clearly suggests there’s a very strong rapid antidepressant effect, but we don’t have great data on the longer-term efficacy and safety. I’ve had many patients who were acutely suicidal, have taken this medicine and report within 24 hours that they’re no longer suicidal. We see these amazing turnarounds, and we see them not uncommonly.”
However, researchers are still uncertain how the drug works and exactly what it is affecting in the brain, which is the primary concern about its use. They also do not know the effects it has on the brain and body over time, what happens when a patient stops taking it or the adequate dose for treating a patient.
Because of all the unknown factors, Dr. Sanacora only prescribes ketamine to patients when all other treatments fail. Even then, these patients are closely monitored for adverse side effects, addiction, and more. Ketamine is not a drug that one can go pick up from the pharmacy. The drug is usually administered personally by the physician, and the patient is followed up with regularly to watch for any signs that the drug should be discontinued.
Time notes that currently, only 368 patients have been treated with ketamine in official clinical trials. This number is not nearly large enough to be considered a clinical trial for FDA approval despite the thousands who have benefitted outside of tests. Researchers admit that the drug needs a lot more study before it could become a standard treatment for depression. However, the data that has been collected so far looks promising. With approval for a large-scale clinical trial, the speed of the study could be expedited. To this end, there is good news.
— U.S. Reality Check (@USRealityCheck) August 18, 2016
CNN reported last August that “the Food and Drug Administration put the experimental drug esketamine (also known as ketamine) on the fast track to official approval for use in treating major depression.”
With the government fast-tracking research, we may see ketamine approved for clinical use soon. In the meantime, the off-label prescription of ketamine is still perfectly legal. However, the question of ethics remains hazy.
On the one hand, treating a suicidal patient with a legal drug that has proven effective in the short term seems like the ethical thing to do as opposed to letting them kill themselves or remanding them to an institution. On the other hand, those who have prescribed the drug admit that they do not know enough about its effects in the long term, so prescribing ketamine could be hurting their patients down the road.
Like the doctors prescribing it, we will just have to wait to see if ketamine is an FDA suitable drug for use as an antidepressant.
[Featured Image by Phil Walter/Getty Images]