Bait and Switch: the Great Ketamine ‘Breakthrough’

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From RxISK: “The Spravato story, it seemed to me, was a bait-and-switch on two levels:

  1. The buzz around this drug had been based on impressive results from IV ketamine treatment: one or two full-dose infusions, with no attempt to suppress the dissociative or ‘trip-inducing’ effects. But ‘esketamine inhaler therapy’ was a different animal altogether: a lower dose designed to minimize these effects, and thus be suitable for long-term use. The results had been remarkably UN-impressive. Meanwhile, the hazards of using esketamine on a ‘maintenance’ basis were unknown. They might be completely different from those associated with one or two full-on ‘trips.’ There were at least three suicides in Janssen’s inhaler studies – all in the treatment group.
  1. The second bait-and-switch: ‘Severe depression’ with an imminent risk of suicide was cited as the condition for which this drug was so urgently needed. And IV ketamine did seem to work rapidly for such patients. But those were not the patients chosen to test Janssen’s inhaler: subjects with any suicidal ideation or behavior in the past six monthswere excluded! Instead, the target was patients with treatment-resistant depression or ‘TRD,’ defined as those who had tried at least two antidepressant pills without adequate relief.

That is not to trivialize TRD – most people carrying that diagnosis are definitely suffering. But the majority are not at imminent risk of suicide or otherwise in acute crisis. More commonly they are trapped in a chronic state of low energy, low motivation and ‘anhedonia’ or inability to feel pleasure, which can drag on for years.

I know, because I’m one of them – and I almost enrolled in a Spravato study. Here’s what I learned from the experience.”

Article →

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8 COMMENTS

  1. If you want to see how the FDA approval process is broken, read this RXrisk article and the accompanying material from FDA reviewers. Be warned, you may feel somewhat out-of-body as you read it, just like the participants in the trials. It will defy all your beliefs:
    1. Participants are treatment resistant. Nothing worked – next stop ECT. But they get 16 points out 60 better on the placebo! Some treatment resistance!
    2. So the drug, which >50% dissociate on and many others get dizzy, thereby probably unblinding the study, gets 20 points improvement. So, just as Kirsch found ~80% of the antidepressant effect is placebo.
    3. They havent got a second proper study, at least 2 other trials simply failed to show anything. Fantastic.
    4. So they used a “relapse” study, which showed twice the relapse rate on the placebo. Of course, this would be unblinded. because as soon as you find you aren’t going loopy, you know you have been taken off the drug and the beneficial effect, which was 80% placebo, vanishes. So the placebos relapse straight away and the drug users some months later.
    5. But how about this? Over half the placebo group DON’T relapse at all in 18 months or so ! Has 4 weeks of snorting the drug rewired their brain? Have these treatment resistant people for whom nothing worked suddenly got better? Who knows!
    6. And finally, this: “There were six deaths in the esketamine for treatment-resistant depression development program as of January 8, 2019, all in esketamine-treated subjects.”

    But we have a new drug, in fact a new family of drugs.

  2. Yea!!!!!!!….I can hardly wait for all the people that will be brought to the “hospital” where I work and they will be labeled as schizophrenic because they will be psychotic on this junk. Who would allow a drug to be used on them that was derived from a large animal tranquilizer? Who in their right mind would allow themselves to be dosed with this junk? The studies prove that this is junk science and snake oil medicine but I bet that Jansen will make tons of profit off of it all and people will be flocking to their doctors to get a prescription for it. What is wrong with this picture?

    • “Who in their right mind would allow themselves to be dosed with this junk?”

      I think you may have proved your point right there. The people who *are* going to be getting these treatments are desperate. This promises almost instant relief.

      I really can’t blame anyone, though. We’re taught that our brains are broken. That medicine can save us from ourselves. It’s easy to justify any treatment if you’re just trying to make the pain go away.

  3. I really can’t believe they’re pushing esketamine even though it doesn’t have the research to back it up. These experiments should have to be repeated at least a few times and their effects tested before it goes to the public.

    I feel bad for the people who may take this and have a “bad trip.” My brain does the dissociation thing all by itself and it’s *not* as great as most people think.

    This just makes me frustrated because they take advantage of people who are suffering and looking for a way out. If it were a one time dose, then it’d be a different story. But it is a twice a week dose for a month and then “maintenance” doses for who knows how long.

    It’s a good cash grab, though, as more people are labeled as “treatment resistant” these days and the use of psychiatric meds continues to climb to higher and higher.