Ketamine: What’s God got to do with it?

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March 11, 2019 | 20 Comments

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  1. This is fascinating … but a bit hard to grasp. I had a few questions:

    If the Spravato inhaler is unlikely to do what Ketamine injections do, is that because of the dose they’re using – or because inhaling the drug will affect people differently from injections? Or both?

    The #1 “caution” about Spravato expressed both by cheerleaders and critics is the risk of abuse and diversion. Mainly, that’s because they all seem to assume that it’s similar or identical to Ketamine injections. Which it’s not. (For one thing, its effects on depression were surprisingly weak in clinical trials, and not especially rapid either.)

    You seem to be saying that Ketamine does not cause dependence (or addiction). Is that based on the experiences of recreational drug users, or on the outcomes of using Ketamine injections in the clinic? And do we know whether snorting esketamine long-term (say, twice a week for 6-12 months) could cause dependence or withdrawal effects?

    Last question: What does it mean to say that a drug is “pro-convulsant,” if it does not in fact cause seizures when used in normal doses? Is there some sub-threshold seizure-like process being triggered in the brain? If so, what are its benefits – and what are its hazards?

    • Jo

      Who knows about Spravato. But the standard wisdom is that PCP and ketamine do not cause dependence. They give intriguing experiences that people might want to repeat because it was very very different but not because it was hugely pleasant and not because you are left craving it. “Strange drug that” – is a common response. For many people once is enough.

      Pro-convulsant sounds mysterious sure. Read the article. Basically it means tonic. There were two groups of drugs – one strengthens the nervous system – tonics – the other weakens it – sedatives. Strengthening the nervous system sounds a lot better than pro-convulsant but as with strychnine you can strengthen it all the way up to a convulsion. At least with strychnine you die with a fixed grin on your face.

      There are other ketamine cautions – as with everything its people who tell me about these things rather than the literature – one of the problems can be urinary difficulties. Seems to have a bladder irritant effect. Don’t know if this is when used too much or whether it can happen after a few exposures.

      David

  2. Further output from Janssen ‘Carepaths’ giving more ‘details’ about ‘safety’ information …

    Welcome to Janssen CarePath

    We’re here to help with Janssen Medications

    At Janssen CarePath, we’re committed to helping you get your patients started on the Janssen medications you prescribed, finding financial assistance options, and providing ongoing support to help them stay on prescribed Janssen therapy.

    https://www.janssencarepath.com/hcp/spravato

    SPRAVATO™ is marketed by Janssen Pharmaceuticals, Inc.

    Important Safety Information For Spravato

  3. Thanks! I did hear an interview with addiction specialist Anna Lembke in which she described a guy she was treating for opioid dependence (recovered) and depression. He reported feeling more depressed; she suggested changing his antidepressant, but he asked if he could try ketamine instead. When she would not supply it, he got it off the internet — and began injecting several times a day. He ended up having several seizures and a Parkinson’s-like movement disorder that took at least a month to clear up. Not sure if he developed “ketamine dependence,” or if his K use was just an expression of an “addictive” or “compulsive” behavior pattern.

    As for PCP, it is maybe the ultimate “demon drug” in the USA, with a longstanding reputation for triggering horrible violence. The only case I know of where a murderer was found not guilty due to the influence of illegal drugs, involved a guy who smoked a joint that (unbeknownst to him) had been treated with PCP or Angel Dust. I’ve heard PCP is no longer used as an anesthetic because people would sometimes be very combative on “coming to.” But you never hear this about ketamine, which is still used for invasive scoping procedures, etc. I wonder what the difference is?

  4. Thank you very much Dr. Healy. You are always helping to think with a critical open perspective, alternative to the “evil pharmaceutical consensus” who wants to transform us in non thinking prescriber profesionals. I really appreciate your opinion, it helps me think my patients in my every day practice. Greetings from Argentina

  5. I know very little about Ketamine – other than of its use as a horse sedative! However, 12 years ago we provided a home for a heroin addict on his release from prison. he lived with us for over two years. He was in his forties, the son of a drug dealer, therefore he’d been around drugs for most of his life. He spoke of ketamine with fear – he’d used more or less all street drugs that would be available in north wales – but ketamine, he would not touch. He’d seen it used, and seen the effects on some of his mates – it was the state of those ‘mates’ once the ‘trip’ was over that frightened the life out of him. I therefore deduce that it’s not very nice stuff!
    Spravato may well be miles away from ketamine found on the streets I guess, therefore who knows the effects – positive or negative – in its use to treat depression. It is so innocently packaged, could it have a sting in its tail if misused? Also, is it possible that there could be side effects if prescribed to patients who are merely anxious or in life crisis, similar to what has happened with SSRIs?
    An afterthought – IF it became the drug of choice out in the community, then it would be much easier to detect than a few tablets I suppose. Allergy sufferers had better leave their nasal sprays at home if that happens!

  6. According to the FDA News Release – the FDA Gave Approval for the Release of Eskatamine (Spravato) on Tues 6th March to Janssen Pharmaceurtical Ltd ( NBC News page updated 7/3/19 )
    This despite one of the Boxed Warnings side effects cautioned against – is’ suicidal thoughts and behaviours’.
    ‘The nasal spray will cost $590 for a dose of 56mg and a dose of 84mg will cost $885. Insurance cover is anticipated’.
    The spray is to be given in conjunction with another anti depressant.

    ‘This is a pivotal moment in the history of mental health’ – we’ve heard that before.

  7. Ibogane is another similar option depending on where you are, or where you are able to go. It’s used to treat opioid and alcohol addiction. People report feeling as if they’ve completed significant emotional work after just a short treatment as opposed to spending years in recovery or on medication assisted treatment. Cravings are said to disappear. It’s the emotional healing piece that releases the person, so it doesn’t seem like something that would help with the kind of withdrawal we face with benzos, etc. I don’t know if it’s used for depression. Seems like it might, though a rather quick fix and is not without risks.

    • Dependence on SSRIs and benzos is quite different and as mentioned ketamine looks to me contra-indicated. There were a number of suicidal events in the trials – I wouldn’t be surprised if they were linked to this

      D

  8. If this is the case, that Spravato is contra-indicated to SSRIs then surely this could lead to a legal minefield.

    There were deaths and suicides in the trial, with seemingly little relevance …

    This lawyer bigs up Spravato, but, he might not be so chipper if suicides start appearing after using the Esketamine in Spravato ..

    https://www.lockslaw.com/blog/2019/03/11/can-prevent-suicides

    If someone is taking an SSRI, having a hard time and wrongly diagnosed with treatment resistant depression then in all likelihood, Spravato could tip the balance in the wrong direction?

    This could protect an SSRI suicide legal case against a manufacturer if the contra-indicated theory is unknown?

    Reposted:
    https://www.statnews.com/2019/03/05/fda-approves-esketamine-antidepressant/

    The FDA has also expressed concern that patients could be harmed if they experience dissociation, or an out-of-body experience that can leave people less aware of their surroundings. In briefing documents submitted before the advisory committee meeting, the agency also noted six deaths — including three suicides — among patients who were taking the drug. But FDA reviewers said that given that the patients had severe illnesses and there wasn’t a pattern seen in the deaths, it’s “difficult to consider these deaths as drug related.”

  9. Reading about all the different outcomes seen from ketamine injections makes me appreciate how much we lose moving from a world in which there are good doctors and bad doctors who deal with such ambiguously-effective interventions, to a world in which there are no good and bad doctors, only certified doctors who follow the unambiguous guidelines. In one world, doctors may make mistakes, but may also learn from them; in the other world, there are no decisions and no mistakes by definition. All the decisions were made centrally and admitting they could be mistaken becomes an existential threat to the system.

    There’s a very strong centralization imperative I’m seeing everywhere that doesn’t make a lot of sense, not even business sense, necessarily. Boeing is in the news lately because they made a central decision, a guideline if you will, about how their autopilot will work, ostensibly to protect the public from potential pilot error… and that decision may have been mistaken. If a plane crashes due to careless or badly trained pilots, that is a serious problem, but not an existential threat to Boeing or to aviation; but if a plane crashes because Boeing made a centralized decision, that plane model will be grounded worldwide and the company’s stock price takes a plummet. Fortunately two crashed planes are not as easy to hide compared to thousands of drug wrecks, or else I imagine the people at Boeing would be seriously tempted. Rather than trying to design guidelines for the perfect autopilot, a better nefarious business strategy might be to save the effort and get people to accept a world in which pilots can be good or bad at what they do.

    (Sorry, I originally submitted this comment on the wrong post on DH’s personal blog… this is the comment for the right post.)

    • Hear, hear! Let’s go back to understanding that doctors, like the rest of us, are human! Humans make mistakes – and, generally. learn from them. Being the puppets of pharma and government, and believers of ghostwritten materials, has left doctors as being little more than robots – simply middle – men between the manufacturers and patients. How on earth is job satisfaction possible in such a scenario? It is no wonder that more and more doctors seem to have poor mental/physical health. I, too, would be bored to tears if not allowed to make decisions, by recalling from my experience and using such in the best interest of those in need. Having said that, I do feel that we, the patients, also have responsibilities – to tell our doctors, clearly, why we reject certain medications; to return unused medications with our reasons for not continuing with their use and asking for clarity concerning any medication that is suggested for our use. By doing so, we prove that we are ‘thinking beings’ and, thereby, less likely to be harmed by our prescribed medications. Our doctors are not robots – AND NEITHER ARE WE!

  10. Update:

    What is the SPRAVATO™ REMS (Risk Evaluation and Mitigation Strategy)?

    https://www.spravatorems.com/

    A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product.

    The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO™ administration, and abuse and misuse of SPRAVATO™ by:

    Ensuring that SPRAVATO™ is only dispensed to and administered in medically supervised healthcare setting that provides patient monitoring
    Ensuring that pharmacies and healthcare settings that dispense SPRAVATO™ are certified
    Ensuring that each patient is informed about serious adverse outcomes from dissociation and sedation and need for monitoring
    Enrollment of all patients in the REMS (registry) to further characterize the risks and support safe use

    SPRAVATO™ is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO™ must never be dispensed directly to a patient for home use.

    • REMS strategies are a great way to bankrupt a health service while leaving pharma able to claim their drugs take the same proportion of health budgets as they took in the 1960s.

      DH

  11. They wouldn’t treat an animal like this. Ketamine was banned as a drug given to race horses . Want not waste not – millions of human beings are being diagnosed as severely depressed – Spravato!
    As nobody will be able to give truly informed consent to taking Spravato , there is no way of weighing up the risks , the information only states there are risks . People are being prescribed it while the risks are still being very heavily monitored – in effect they are the ongoing guinea pigs for the drugs company if as it it seems they not being informed they are part of continuing research called ‘monitoring’.. What would a person’s legal rights be if s/he was picked up in a dissociated state which can be put down to alcohol or illegal drugs, especially if
    over the two hours specified after leaving the clinic? People can end up being incarcerated in a prison or psychiatric unit where the situation will not be understood and the person not able to explain their state is caused by a legal drug’s side effects. If anyone agrees to being administered Spravato they should be offered a tag to use in the same way people with epilepsy and at risk of having seizures can use them. The dose is presumed to take takes two hours to settle down but there is no way of telling how long the adverse effects will last and no way of stopping them if they become severe and frightening – much like the effect of LSD and ketamine which have to run their unpredictable course over time and regardless of what is thrown up in altered states there is no antidote.

  12. Patrick D Hahn
    Yesterday at 06:07 ·

    Baltimore Sun

    For your consideration:

    Today, The Baltimore Sun published this opinion piece by Patrick D Hahn about the nasal spray antidepressant esketamine that the FDA approved on March 5. “The recommended course of treatment for this drug, which is to be administered only in a doctor’s office, is twice-weekly for one month, followed by weekly or biweekly treatments thereafter. It comes with a price tag of $4,720 to $6,785 for the first month of treatment and $2,360 to $3,450 per month thereafter, which means the cost of a year’s treatment could be as high as $44,735. This is the same stuff (admittedly in purer form) that you can buy in a nightclub bathroom for a good deal less. Disturbingly, there were three suicides in the trials, all in the treatment arm. This finding becomes even more ominous in light of the fact that actively suicidal patients were excluded from these trials.”

    Know Your Drugs

    https://www.tribpub.com/gdpr/baltimoresun.com/

    https://www.facebook.com/patrick.d.hahn?__tn__=%2CdK-R-R&eid=ARCjc_gnRYN9kByVs27_mNjQLfRaAnYGOOeiER4GfCZqdOXYxmapx6A4eAI7yEpAOFtD41GJ-KAF4vho&fref=mentions

  13. I must leave my comment anonymously because I work in the field as a therapist, and I also have a history.

    PCP, is a drug with nasty consequences, I have seen this drug used illicitly, and as a drug counselor while in grad school, I noticed that its use is a rarity. Most drug users that I treated, only used it by accident. And when the did, were not happy with the experience.

    At one time it was associated with gang members, who used it, and I know of some that was shot while under the influence, and saw this happing to someone else, the other them.

    Which brings me to my point. PCP, and Ketamine, are dissociative anesthetics, that were initially developed for use in labor and delivery. But were discontinued for that because mothers post delivery could not bond with their infants. They did not know why there were in the hospital.

    Users who like the drug describe the experience as being voided out, or out in the “void”, and will typically need someone sober with them to keep them oriented or risk having a break.

    My perception is these drugs, disassociate pain, as if it is happening to someone else, and this could account for their effect on someone suffering from depression. The symptoms are still there but their are happening to the other me, not me but someone else.

    It was also found during clinical trials that a significant number of those tried on the drug PCP had subsequent psychotic breaks. I think that this is a significant risk also from Ketamine. For example John Lilly using it to talk to GOD, and curing his life long depression simultaneously.

    I think what is happening is that pharmaceutical companies are looking for a disease to treat with a drug that’s already approved.

  14. Ketamine was also used in a psychotherapeutic context (following the ban on LSD) by the Greek neuropsychiatrist Athanassios Kafkalides who came to very similar conclusions with Stan Grof regarding pre- and perinatal memories and the therapeutic potential of psychedelic-sssisted psychotherapy.

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