a story: the first ending…

Posted on Monday 28 December 2015

When something’s wrong, it’s a lot easier to say what’s wrong than it is to know what to do about it. The cross-fire of the academic-industrial complex and Managed Care is a choke-hold that rarely lets one come up for breath. Here we are about to finally escape from under the patent-life of all these drugs, and up pops Rexulti®, an Abilify® clone, and the FDA grants them a benefit-of-the-doubt approval for this Atypical Antipsychotic Augmentation of Treatment Resistant Depression indication coming right out of the pipeline.

The only thing I know to do is to try to chase down and make public how much of a cliff-hanger this FDA Approval was, and to try to make the actual state of affairs in the profile of this drug as clear as possible [see a story: the beginning of the end…]. I hardly know what to make of the way this was published – two ghost-written industry prepared articles with only one academic author, a notorious KOL at that, in back to back articles in the same journal with a lot of identical text; attempting to sell the idea that changing a protocol in midstream is an acceptable bit of science; living on p-values while ignoring Effect Size measurements. It’s really a bit too much all around.

I personally think that the antipsychotic drugs, atypical or otherwise, are too dangerous to give to patients with "office depression" and wouldn’t think of doing that, even if they worked well. When I found myself in an office full of people on them, I discontinued them pell mell. The patients felt better [and so did I]. So I never really looked into the literature that addressed Atypical Antipsychotic Augmentation of Treatment Resistant Depression. But the publication of a Clinical Trial in this month’s American Journal of Psychiatry lead me down that path through the articles and meta-analyses. About halfway through, I realized I was writing a story, so I included that in the titles. I’ve even made up a name:

    December Tales

It’s a story about using antipsychotic medication frivolously, in my now entrenched opinion. If you use Atypical Antipsychotic Augmentation of Treatment Resistant Depression, I’d suggest you read these posts, or at least glance at the references [see particularly 5, 8, and 12]. I found where this practice was first tried [see 6], and I’ve gradually realized that it has been an excuse to use dangerous medications casually. It’s situations like this that make Data Transparency such an essential goal. I had a really difficult time gathering all the pieces for my Rexulti® posts [7, 9, 10, 11] and Spielmans et al had to scramble for their meta-analysis [5]. It’s absolutely silly for the pharmaceutical companies and the FDA to continue to hide the raw data, and it’s time for it to stop. That’s just a given. In the meantime, I hope people will join in the task of going over these articles with a fine tooth comb in vetting these industry productions with all their spin.

If there’s a prime example to illustrate why the Direct-to-Consumer advertisements need to be taken off the air, psychiatric medications are the prime contender. The ads have been relentless, misleading, and the very real damage from the overmedication in part fueled by these ads is all around us. The AMA has recommended that they be banned [damn the torpedoes! full speed ahead…]. I’d up that recommended to demanded were it up to me. Those ads are as destructive as the cigarette ads used to be, and deserve the same fate.

And speaking of prime examples, this story of the Atypical Antipsychotic Augmentation of Treatment Resistant Depression is one to use to illustrate how commercial interests have invaded medical practice. Besides the obvious dangers of the Metabolic Syndrome and Tardive Dyskinesia, these drugs don’t really do what they’re advertised to do – make the antidepressants work a lot better. They seem to have a small effect [weak at best], but the Effect Sizes are surprisingly low, and the feedback from self rated scales barely registers any clinically relevant effect. I’ve maxed out my boring-ness to make this story available with the appropriate reference in hopes that people might happen by and take a look…
    December 29, 2015 | 5:18 PM

    Mickey, thank you for having the kishkas to do this work.

    Rachel Goldberg
    December 29, 2015 | 6:43 PM

    Thank you for compiling information that is not easy to find.

    James O'Brien, M.D.
    December 29, 2015 | 10:35 PM

    Sometimes I wonder if the real target of those ads are really doctors watching TV. I mean the multiplier effect would be much greater if you flip a doctor to your drug as opposed to a single patient.

    Sadly, I know some PMDs and even lazy psychiatrists who are heavily influenced by those ads. I even had a psychiatrist once comment after I questioned an SGA in a nonpsychotic depression that I should pay more attention to the Abilify ads and he likes to use it for “emotional control”. No worries about TD, he claimed because that was all from the older antipsychotics. I’m not kidding.

    Someone Else
    January 5, 2016 | 10:00 PM

    My concern regarding atypical antipsychotic augmentation of treatment resistant depression is that it is already medically known that combining the antidepressants and antipsychotics can cause anticholinergic toxidrome.

    “Substances that may cause this toxidrome include the four ‘anti’s of antihistamines, antipsychotics, antidepressants, and antiparkinsonian drugs[3] as well as atropine, benztropine, datura, and scopolamine.”

    And especially given the central symptoms of anticholinergic intoxication syndrome:

    “Central symptoms may include memory loss, disorientation, incoherence, hallucinations, psychosis, delirium, hyperactivity, twitching or jerking movements, stereotypy, and seizures.”

    Are almost identical to the positive symptoms of “schizophrenia.” It’s likely this antipsychotic / antidepressant induced toxidrome could frequently be misdiagnosed. Especially given the fact it’s not even mentioned in the DSM as a possible cause of “psychosis,” and even psychiatrists can all suffer from the problem of “out of sight, out of mind.”

    Winge D. Monke, PhD (WDM)
    January 6, 2016 | 10:40 PM

    The peace would be heavily disturbed if the psych drug fad hadn’t coincided with the fascinating, fantasy-fulfulling, self-swaddling Id-ternet. Out of mind, out of sight.

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