Are Ketamine Clinics Creating Risk for True Psychedelic Adoption?
Pushing the highly-addictive dissociative drug ketamine confounds the clinical introduction of psychedelics as therapy.
Image credit: Wall Street Insanity
I was surprised a few months ago by an announcement in the trade magazine, Psychedelic Spotlight proclaiming the world’s first psychedelic-assisted therapy clinic was set to open its doors in Bristol, England.
“UK on the Brink of a Psychedelic Therapy Revolution” shrieked another headline in Filter Mag.
Like anything that seemed too off-the-wall to be true, it wasn’t. None of the psychedelic drugs currently candidates for legal therapeutic treatment—the entactogen MDMA, psilocybin and in most countries, LSD, are available to ordinary patients through medical prescription—not in the US not in the UK, nor for that matter in the EU, Israel, or Brazil. The single exception to this prohition comprises a tiny group of psychiatrists in Switzerland who are licensed to administer LSD and MDMA to a very small number of clinical patients in a small number of clearly defined circumstances.1 Researchers in Switzerland are also conducting clinical trials with LSD to treat cluster headache, major depression and anxiety related to severe somatic diseases.
What the clinic was actually selling, it emerged was the non-psychedelic, dissociative anaesthetic drug ketamine, in its recent off-label use incarnation as a rapidly-acting drug to treat depression.
There is nothing either new or revolutionary about ketamine, or ketamine clinics. Despite it’s owner’s misleading advertising, Toronto-based Awakn Life Sciences Inc, ketamine clinics have have been cropping up like dandelions in the US, the UK, and the EU (Germany, Switzerland, Spain, and the Czech Republic so far) the last few years.
Dr Ben Sessa, the Chief Medical Officer of the UK division of Awakn, will direct the clinic which will begin life as a ketamine clinic, and then move as soon as possible thereafter to a bona fide psychedelic therapy clinic offering therapy with MDMA and psilocybin. He himself has not worked with ketamine previously. It’s not his first choice. In the interest of getting what he hopes to be a burgeoning business up and running, he’ll make use of the single drug on offer until others become available.
“I’d much rather working with MDMA and psilocybin,” said Dr Sessa. “We’re opening a ketamine clinic immediately because we can.”
Trained in psychedelic psychotherapy by way of extensive work running clinical trials under the direction of Dr David Nutt at Imperial College, Dr Sessa plans to adapt his knowledge and experience with psychedelics, making use of ketamine’s signature dissociative and hypnotic properties to explore interior spaces in a way that promotes emotional and spiritual growth. He’s not going to run a clinic where people go in, hook up, to an intravenous infusion for a few hours, and go home, where the only guidance provided by doctors are words to the effect: “sorry you’ll feel weird for a few hours, then you can go home.”
Dr Sessa calls these infusion farms. There is one run by Oxford Health, part of the Oxford NHS Foundation Trust, which Dr Sessa visited on one occasion.
“They had patients in cubicles hooked up to drips, all lined up sort of as if they’re being milked,” said Dr. Sessa. Patients have an initial psychiatric workup costing £150, then three ketamine treatment infusions, at £215 per infusion. They can opt for additional infusions for £195 each. The only oversight by a consulting physician consists of one in person review at least every six months.
Dr Sessa plans to open additional psychedelic clinics in the UK over the next several years. It’s a for-profit venture, only available privately and not through the NHS.
“I’m not going to wait for the NHS to take it’s thumb out and start paying for these treatments,” he said. “That could take a decade.” New drugs, he points out, are often available only to private wealthy clients, initially, until they’re adopted for main stream use. In the US, I’d say all bets are off when it comes to the likelihood of insurers underwriting psychedelic therapy.
For Dr Sessa, ketamine is a stop gap until MDMA and psilocybin are approved for use as bona fide psychotherapeutic treatments in clinical settings. For the time being, psychedelics, in which the entactogen MDMA is generally included, are only available clinically in expanded access and compassionate use programs in the US and Canada.
The Canadian government last year granted four terminally ill cancer patients permission to use psilocybin in the context of guided therapeutic sessions to treat anxiety, depression and the psychological distress experienced by those facing imminent death. Under Subsection 56(1) of the Canadian Controlled Drugs and Substances Act, the Minister of Health can exempt any person or class of persons or any controlled substance or precursor or class thereof from the application of all or any provisions of the Act or the regulations if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.
In the US, the FDA has granted an “Expanded Access” designation to MDMA for eligible patients with treatment resistant PTSD. According to the Clinicaltrials.gov: “This protocol is designed to provide access to MDMA-assisted psychotherapy to patients who are not eligible for any other ongoing MDMA-assisted psychotherapy clinical trial.” It will cost those who can get it a heap: around $15,000.
Ketamine was first synthesized by Parke Davis Company in 1956. The FDA approved ketamine in 1960 for use as an anaesthetic. It was first used during the Vietnam War, as a battlefield anaesthetic. Ketamine causes sedation, unconsciousness at higher doses, decreased pain perception, increased sympathetic activity (like elevated heart rate), and maintenance of airway tone and respiration. It is this last characteristic which made ketamine a go-to battlefield and ER anaesthetic. Unlike many other anaesthetic drugs, it isn’t likely to cause respiratory depression, making it much safer than alternatives when dealing with patients who were unable provide verbal information about possible risks: the unconscious, the combat-wounded, children.
Ketamine quickly became a street drug under the names Special K, Cat Valium, Kit Kat, K, Super Acid, Super K, Purple and Special La Coke, among others.
As a street drug, it’s toxic and very addictive.
“One person I know had his bladder removed due to the amount of ket he used over the years. The walls of his bladder became too thick which prevented urine from passing through,” wrote Nathan Harmer in The Independent. Mr Harmer started using ketamine to self-medicate his depression when his grandmother died.
Its abuse among anaesthesiologists is a well known occupational hazard.
Ketamine was first reported to have antidepressant properties in 2000, when it was demonstrated that an intravenous administration of a sub-anesthetic ketamine dose resulted in a rapid reduction of major depressive symptoms lasting up to 72 hours after treatment. Subsequent clinical trials replicated this finding. Overall, there was a 60-70 percent reduction in symptoms. Ketamine has a rapid clinical effect, lifting depressive feelings within two to four hours after administration. A lot faster, in other words, than the industry favourite, whose efficacy has come into question over the last few years, SSRIs. But its antidepressant properties are also transient, lasting an average of one week following a single infusion.
To be effective, ketamine doses have to repeated. Again and again and again. The infamous neurophysiologist John C. Lilly who started his career in 1952 as head of the Section of Cortical Integration at the National Institute of Mental Health in Bethesda, Maryland, ended his career as ketamine-addicted cult figure, a “far-out guru of consciousness exploration, promoting the use of psychedelics and sensory isolation tanks.” (Remember the movie Altered States?) Lilly’s ketamine use began when he discovered the drug as a means to treat his intractable migraines. It was the only drug that worked. His slide into multiple daily doses and serious addiction went from there.
The FDA’s consecration of ketamine as a Schedule 3 drug—unlikely to have adverse affects with “a moderate to low potential for physical and psychological dependence” doesn’t make make it either non toxic or risk-free. Maybe more remarkably than other drugs, ketamine presents problems when used off label, which, bear in mind, as an antidepressant, it is.
There’s a kind of institutional bias, said Capt. Sean J. Belouin, Pharm. D, Senior Policy Advisor at the FDA, to believe that a drug, once it’s approved, is actually safe.
“Once a drug has been approved, even for a very narrow usage, doesn’t mean it is without safety issues,” he said.
In other words, there are no built-in protections once drugs are on the market; and there’s no way to control off-label use, as with ketamine.
“Ketamine has addictive properties” declared the Harvard Health blog on ketamine for major depression. “If you have a history of substance abuse—such as alcohol or drugs—it’s especially important for you and your doctor to consider whether ketamine is a good option for you.”
The National Library of Medicine, and the National Center for Biotechnology Information gives this addiction profile:
“Ketamine is a parenterally administered, general anesthetic used largely for short term diagnostic and surgical procedures, but which has been limited in use because of its psychological side effects including vivid hallucinations, agitation and confusion. Ketamine also has major abuse potential and is used illicitly as a recreational drug. Long term ketamine use can cause inflammation and irritation to the urinary bladder and urethra, and similar changes have recently been described in the biliary tract, resulting in an acute or chronic cholestatic liver injury that can resemble sclerosing cholangitis.”
What other pharmaceutical drugs have gone down this road?
Oxycontin was also a legal drug, a long-acting opioid pain reliever, with a known addiction profile. The drug's manufacturer pushed docs to prescribe it, and gave them financial incentives to do so. Look how well that ended.
Ketamine does not appear to be too different: it has known toxicity, and major abuse potential.
The recently-approved ketamine preparation, esketamine, which was rushed through the approval process for political reasons, has caused even more alarm.
According to an article in ProPublica: “In one of the [clinical] trials, six people taking the drug died, including three by suicide. One of them, a 41-year-old man, drove his motorcycle into a tree 26 hours after taking the drug, according to the transcript of the FDA’s hearing on the drug. There were no deaths among the patients taking a placebo.”
Dr Alan F. Schatzberg, writing in the American Journal of Psychiatry had this to say:
“What is more worrisome than this rapid relapse coming off even less frequent esketamine administration were the three suicides that occurred 4–20 days after the last dose of esketamine (there were none in the placebo group). Two of the patients who died by suicide showed no previous signs of suicidal activity during the study, either at baseline or at the last visit. This suggests a protracted withdrawal reaction, as has been reported with opioids, and one that is different from the more physical withdrawal symptoms seen acutely with opioids.”
Sounds a lot like a highly addictive drug with a dangerous withdrawal profile to me.
On an individual basis, psychiatrist Peter Gasser is able to apply for exemptions to compassionately use MDMA and LSD since 2014. He has been working as a psychiatrist and psychotherapist in private practice since 1997 in Solothurn, Switzerland.