Our last blog cautioned that pharmaceutical history is filled with hyped “miracle” drugs that turned out to be substance abuse disasters.
There is an inherent human tendency to exaggerate the benefits of something new, while underestimating its long term risks. This is amplified when the something new gets hyped by a drug company that stands to make big profits by pushing just the positive side of the story.
Which brings us to the strange case of Ketamine – a versatile substance that has long led a double life, serving both as a useful anesthetic and also as a popular, but dangerous, party drug.
Ketamine is now being given a third possible starring role as a new miracle drug for depression. The story is hot now because the FDA recently put Ketamine on its new fast-track status toward quick approval. It is being touted as a possible “breakthrough therapy” for Major Depressive Disorder and for preventing suicide and is gushingly described as the first really new treatment for these problems in 50 years.
A very simple chemical first synthesized in 1962, Ketamine was soon tested in animals and then tried in human prisoners. Its first clinical use as an anesthetic, analgesic, and sedative was in American soldiers during the Vietnam War. Ketamine remains in use as an anesthetic and painkiller in humans and is used even more frequently for these purposes in animals.
Ketamine works by producing a trance-like state of dissociation and derealization – the person feels detached from himself and his body and the world feels unreal. For some, this is an interesting and pleasant experience. Ever since the early 1970’s, Ketamine has found a prominent place in the recreational drug market, where it is affectionately called “Special K.”
Ketamine’s fast onset of action and dreamy, psychedelic effects make it especially popular as a dance club and rave drug. It is used this way all around the world, sometimes substituting for, or impersonating, ecstasy. Regular users can develop cravings.
At high doses, Ketamine causes the “K-hole” – a profound distortion of sensory experiences and consciousness, described as “out of body” or “near-death”, and often accompanied by visual and/or auditory hallucinations. And actual deaths do also sometimes occur.
Ketamine can be injected, snorted, drunk, or added to cigarettes or joints- sometimes without the user’s knowledge or consent. Because it can cause immobility, amnesia, confusion, poor judgment and slurred speech, Ketamine is an especially convenient date rape drug.
Despite Ketamine’s designation as a controlled substance, ample supplies are available on the illegal market, mostly produced by labs in China and India.
“Miracle” Drug for Depression?
Ketamine is a classic case of commercial hype and exploitation racing far ahead of scientific proof.
There have been very few systematic studies of Ketamine and no real knowledge of its impact on the long term course of Major Depressive Disorder or suicide risk. The sparse literature consists only of small, short-term, poorly or uncontrolled studies.
The enthusiasm for Ketamine comes not from science, but instead from anecdotal testimonials that some patients feel a sudden and dramatic short term relief from depression and suicidal thoughts.
The Ketamine Advocacy Network provides glowing endorsements and serves as a referral source for the two dozen Ketamine clinics that have opened up around the country, most of them run by anesthetists, not psychiatrists. The drug is given off label, mostly by doctors who have no expertise in diagnosing or treating depression. This is a commercial, not clinical or scientific, miracle.
Even under carefully controlled usage, Ketamine can have appreciable side effects and risks:
- Blood pressure and breathing problems
- Muscle tremors
It is far too soon to know whether Ketamine has a meaningful role in treating depression. It is clearly far too early for the FDA to consider giving it an indication. And it is reckless and premature for commercial Ketamine clinics to be dispensing an experimental treatment as if its safety and efficacy had already been established.
Beyond the obvious, there is also another hidden danger inherent in the exuberant claims for Ketamine and its eventual possible FDA approval.
Let’s suppose, for argument’s sake, that Ketamine does turn out to have some useful role in treating severe, treatment-resistant mood disorder and suicidality and that the FDA does eventually give it some narrow approval for these specific purposes. The downstream risks of such potential future Ketamine approval would be much greater than initially meets the eye. Ketamine’s intended use would be for the very specific and fairly rare treatment-resistant psych disorders. And it would be meant for use under very controlled medical supervision.
But once the horse is out of the barn, there is no telling where it will run. My fear is that the Ketamine promotionals will encourage many people to start using it as self-medication for distress – a practice that is filled with risk and falls far outside any possible reasonable use of Ketamine.
If this concern seems farfetched, consider the cascades of terrible unintended consequences that occurred following FDA approval of OxyContin for pain in terminal illness. Its medical usage soon widened very far beyond its approved indication to include all sorts of chronic pain in the general population.
It is a great mistake even to consider Ketamine before there is any real research on it. And it sends just the wrong message, encouraging Ketamine abuse.-Allen FrancesThe easy availability of OxyContin pills led to the creation of an illegal secondary market. People hooked on OxyContin, whose growing tolerance required expensive and unavailable doses, began switching to the much cheaper heroin supplied by drug cartels. The huge, new opioid market led to the spreading use of fentanyl and carfentanil, whose potency is hundreds to thousands time greater than heroin. The unanticipated result of approving OxyContin for a narrow and useful indication has been the spreading and tragic opioid epidemic, killing 20,000 people a year.
Eventual FDA approval of Ketamine would likely have similar unanticipated harmful effects. It is a great mistake even to consider Ketamine before there is any real research on it. And it sends just the wrong message, encouraging Ketamine abuse.
The FDA has become a fox guarding the henhouse. It now approves almost all the drugs submitted to it. Instead of protecting the public, it now serves as lackey to Big Pharma, providing a seal of undeserved approval for questionable drugs.
The very real risks of Ketamine far exceed its possible small benefits.
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