The Once and Future Abilify: Depot Injections for Everyone?

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May 11, 2015 | 3 Comments

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  1. In the course of researching this I learned something wonderful about the Randomized Controlled Trial, that “gold standard” route to the truth that supposedly trumps all other evidence. It turns out that a lot of experts who pledge allegiance to the sacred RTC when it tells them what they want to hear, turn into big-time skeptics when it does not.

    A large “meta-analysis” of randomized controlled trials published last year found no advantage for monthly injections over daily pills for preventing “relapse” in schizophrenia.

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3885289/

    So what did the authors do–accept their own findings? Hell no. They rattled on about how RCT’s were “less representative of real-world patients” than naturalistic studies. The oral-meds group might have included too many highly-cooperative patients. The study’s organizers might even have (OMG!) excluded patients “expected to have poor adherence.” (None of this made a great deal of sense. After all, if the groups were randomly chosen, wouldn’t the injection group be abnormally cooperative as well?)

    They concluded they needed “large and long pragmatic studies” to prove what they just knew was true: that injections produced better results in the “real world.” I found this especially touching, having heard them scoff so often at the idea that we should follow people for more than six to twelve weeks if we really wanted to know whether medications “worked.” Good lads, I wanted to say; now you’re starting to think! Can I interest you in a really good article or two by David Healy?

    Probably not. Instead, the authors pointed hopefully to an analysis of “mirror-image” studies that had found a benefit for injections. These were n=1 studies, but of a special kind. Apparently they all involved patients who initially “failed” or dropped out of pill-based treatment, then came back and were put on injections. By definition, only those known to have bombed on Condition One (pills) were being tested on Condition Two (shots)! They struck me as potentially no better than those “Before and After” testimonials you see in cheesy ads for “miracle” weight loss and muscle-building products. The white-coated scientists who usually sneer at “anecdotes” were serving up anecdotes that might make the average patient complaint look like Nobel Prize material.

    The company-sponsored experts who advocate maintenance drugging for everyone refuse to treat either research subjects or “real-world” patients as individuals. They end up abusing the research subjects, the better to abuse the rest of us after the tainted research is published. And it turns out the only side they are loyal to in the great “RCT vs. clinical practice” debate is whichever side their bread happens to be buttered on.

  2. I was kept on a depot injection for a few years even though I was being prescribed lithium and the even though doctors had realized I wasn’t schitzophrenic. I was sleeping 14 hours a day in this chemical straightjacket and suffered a great deal. Prof.David Healy convinced me to come off the depot injection. At first I was very wary because of the fear of another breakdown. I became much brighter and healthier and I have not had a psychotic event for the past 20+ years. What if doctors have wrongly diagnosed some one and pout them on an erroneous regime of depot injections without ever questioning the situation ? It is a frightening scenario and should be top of the list of priorities when considering such a regime of medication.

  3. Last month I added a comment about the drug industry’s failure to show that injections led to better long-term results in Randomized Controlled Trials. This week JAMA Psychiatry has published a study that claims to show just that. And it’s being hailed as a “game changer” for treatment of patients in a first psychotic episode. It’s so important, they gotta let you read it for free:

    http://archpsyc.jamanetwork.com/article.aspx?articleid=2323629

    The study compared Risperdal pills with Risperdal Consta injections in a program that offered cognitive therapy and a supported-employment program as well as drugs. I see two BIG problems in this study that Janssen was able to exploit to make its high-priced injection look good. They’re not subtle–they’re loopholes big enough to drive a Mack truck through.

    The first problem? It was not “blinded.” Both the treating physicians and the raters knew who was on pills, and who was on injections. And this was in a study with a very big psycho-social treatment component! In working with each individual patient, and rating his or her progress, the research team was free to let their Janssen-sponsored hopes and dreams run wild. If they “just knew” Team Injection deserved to win, they could easily make it so–either deliberately, or without consciously realizing what they were doing.

    The second problem? You won’t see it unless you check out their registration on ClinicalTrials.gov (Nos. 00333177 and 00330551). This study was supposed to center on “work and school performance” as its key outcome measure. Yet when the article was written, PRESTO CHANGE-O! The Performance measure had disappeared, and the measure of patient success had become “fewer psychotic symptoms and/or relapse”. Wanna make a bet on what those work-performance ratings showed? The ones they decided not to talk about? Probably very disappointing. This is like setting up a Little League Baseball pitching contest, and then changing it to a batting contest when your kid turns out to be a lousy pitcher.

    The work performance ratings were no doubt included to demonstrate the real-world difference that the injection program was making. Not just better rating scales — Results that Matter! Their unexplained disappearance is the best evidence that injection patients were no better off in a real-world sense. In that case, locking in patients with a first psychotic episode to a regimen of long-term antipsychotics, which can carry such a dreadful physical and medical burden, is inexcusable.

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