prelapse: but there’s more…

Posted on Tuesday 12 May 2015

Recently, when I was reviewing two RCTs for Brexpiprazole, a derivative of Abilify®, I found that each study had only one academic author for each. The rest were pharmaceutical company employees. Both articles had "editorial assistance" [AKA ghost-writers] from the same firm and both were funded and administrated by the drug’s sponsor – Otsuka. Looking further, the two academic authors were from the same Department of Psychiatry at Hofstra and both were associated with the Feinstein Institute. And the two studies were spread over 117 clinical sites all over the US and World [the spice must flow…]. So everything about the studies was industry generated. But there’s more. One of the Brexpiprazole academic authors was also the senior author on a recent Abilify Maintena® RCT and both of them were part of a free CME about Abilify Maintena® [machiavellian medicine lives…]. Otsuka is certainly getting its money’s worth from the Department of Psychiatry at Hofstra. But there’s more. One of the authors on everything I just mentioned, Dr. John Kane, is the Principle Investigator on the NIMH RAISE-ETP [Recovery After an Initial Schizophrenia Episode] Project as well as being Chairman of Psychiatry at Hofstra. That was last week.

But there’s more. This week, I read Johanna Ryan’s article [The Once and Future Abilify: Depot Injections for Everyone?] and found that Dr. John Kane is Principle Investigator on the PRELAPSE study I’ve been talking about here using Abilify Maintena® in first episode Schizophrenia. The study is going to be done by a new CRO, Vanguard Research, at the Feinstein Research Institute. Watch the video to hear Dr. John Kane, founder of Vanguard, discuss this PRELAPSE RCT and hear how the Vanguard network arose from the NIMH study [RAISE?]. Now look at this Newsday article describing the $28M deal to do this study.
Vanguard will manage a clinical trial evaluating Abilify Maintena®, a once-monthly injectable version of a blockbuster drug made by Otsuka America Pharmaceutical Inc. Vanguard is majority owned by North Shore-LIJ. Dr. John Kane, the health system’s senior vice president of behavioral health services, owns a minority stake.
So Abilify® is about to go off-patent, and we have all of this activity – and every bit of it has Dr. John Kane plastered right in the middle of things. The rule is supposed to be that there shouldn’t even be a possibility of Conflict of Interest. In this tangle, Conflict of Interest is all there is to see. This is going to be a short post, because I can’t think of anything to say. The PRELAPSE study is designed to carve out a new commercial indication for Abilify Maintena®, not for any valid clinical reason that’s apparent to me. This is the Academic·Industrial·Complex with Dr. John Kane and Otsuka at the helm at its worst. I rest my case on the evidence as presented…
  1.  
    berit bryn jensen
    May 13, 2015 | 3:59 AM
     

    Thank you! The dots have now been connected for everyone to see and to make the most of. These medical experiments and chemical compounds aimed at the most vulnerable members of society are not necessary in democratic societies. We should play by democratic rules of open information and truly INFORMED consent. These schemes are about silent conquest in order to make more billions of dollars and totalitarian control of the populace, 1984 arriving.

  2.  
    May 13, 2015 | 6:59 AM
     

    I can think of a few more things to say. RAISE is being highly touted by NIMH. As you have pointed out, it was being promoted before the first results were even in. Oddly, in light of PRELAPSE, they found that many people came into the study already on higher than recommended doses of neuroleptic. RAISE – ETP also promoted the use of drugs for which there was an established evidence base in FEP and aripirprazole was not among them.
    But there is now a huge push around the country on early episode programs because the states have been given some money to establish programs to do this. And where do people turn for advice? The academic leaders who ran RAISE, Drs. Kane and Lieberman being at the top of those studies.
    When I was a young person starting out my career in the study of psychosis, Drs. Lieberman and Kane were people I looked towards as role models. Together they had done some fine work on the long term study of tardive dyskinesia and the cautious use of neuroleptic drugs.
    By the late 90’s, I was receiving promotional material from Jansen in which I could get a Risperdal key chain or a reprint from Dr. Kane. I knew then that most of these studies results were being distorted in the many post marketing articles being written. When CATIE came out, there was no retreat, only a turning to the latest and greatest – aripirazole, lurasidone, asenapine, etc.
    There have been studies showing no advantage for LAIs.
    Check out this tortured editorial trying to make an argument in favor of LAI aripiprazole. I find it lacking in consistency. Aripiprazole supposedly does not cause weight gain, but that is not what Kane’s study found. The newer drugs are promoted but there is no evidence they confer an advantage over long acting haloperidol or oral agents).
    http://www.psychiatrist.com/_layouts/PPP.Psych.Controls/ArticleViewer.ashx?ArticleURL=/jcp/article/Pages/2014/v75n11/v75n1108.aspx#ref3
    There is a study cited in which patients were transitioned form long acting haloperidol and fluphenazine to long acting risperidone and they did worse!
    http://www.psychiatrist.com/JCP/article/Pages/2012/v73n05/v73n0515.aspx

  3.  
    Steve Lucas
    May 13, 2015 | 8:02 AM
     

    I have been following a thread on another blog concerning forced vaccinations, not having children I did not realize the growth in mandated vaccinations to attend school or participate in other activities.

    My issue with forced vaccinations is this produces a guaranteed income for pharma while removing choice from the patient and their doctor.

    This also ties very well into the pharma narrative that all medicine is good. Recently another legal suit was filed claiming that drug reps have the right to promote off label uses of drugs under their freedom of speech rights. Commercial speech has for a long time been regulated and this is an established legal concept.

    Australia ties vaccinations to tax benefits. Britain apparently allows children to sign off on receiving vaccinations against the wishes of their parents.

    Troubling is the disconnect between the need for vaccinations and their real purpose. Vaccinations should provide relief for the patient, or protection for the public at large, not promote the pharma narrative of more medicine is good. Coercion is never an appropriate medical goal.

    Steve Lucas

  4.  
    Catalyzt
    May 13, 2015 | 1:53 PM
     

    @ Sandra: It seems like Stroup is carefully trying to camouflage the didactic, “we-know-what’s-best” tone of the editorial, but it leaks through in this sentence:

    “The take-home point is that all patients taking any antipsychotic should be monitored for adverse metabolic and neurologic effects, and if they occur these problems should be actively managed.”

    Maybe it’s just me, but I find it annoying when someone tries to explain to me what’s most clinically relevant about the side-effect profile of a particular therapeutic agent. It’s also a little insulting, as if we’d be too stupid to notice if a patient started gaining weight rapidly or developed TD without the author instructing us to do so.

    But what really set off my BS detector in this article was the overly casual reference to akathisia… almost like, ‘nothing to see here, move right along sir.’

    At this point, whenever I encounter that particular tone, I have exactly the opposite impulse– to linger at the scene and peer over the police tape.

    And in this situation, one doesn’t even have to look very far. Of course, akathisia is going to be a very relevant issue in any population that’s at high-risk for suicide, and it turns out akathisia this is a particular problem in patients who have been taking SSRIs with aripiprazole– not an unlikely situation for a client experiencing symptoms of schizophrenia who may have had some contact with community mental health services already.

    Also, at this point, when someone provides a graph of a metric labeled “Hypothetical Effects of Improved Adherence” my first reaction is… really? The “y” axis is labeled “Outcomes” on a scale from “Best” to “Worst.”

    I mean, that doesn’t even break it down by functioning or mood or affect. It’s just sort of a universal variable for everything.

  5.  
    Winge D. Monke, Ph.D.
    May 13, 2015 | 5:56 PM
     

    Catalyzt, would a doctor like Stroup ever consider that akathisia induced by a long-acting drug is far worse than the alternative?

    Stroup:
    “Because relapse with subsequent hospitalization often occurs in the context of having stopped taking medications.” [Note: no citation for that. Sounds truthy, though.]

    And, doesn’t akathisia itself sometimes go to violence, suicide, and re-hospitalization?

  6.  
    May 13, 2015 | 9:08 PM
     

    Dr. John Kane himself on conflicts of interest in psychiatry http://www.spusa.org/pubs/health_med/mental_health/mh_point_counterpoint.html (from a university student organization concerned with “social responsibility in science and technology”).

  7.  
    May 14, 2015 | 12:34 PM
     

    I lost my job working for a hospital 5 years ago re “forced vaccinations”, as Med Star Health systems here in the Baltimore/Washington area decided they could mandate Flu vaccines for EVERYONE, irregardless if they worked in the hospitals, as I did not, in the outpatient building for outpatient services.

    My having a severe reaction to a flu shot 9 years earlier, and voicing a general objection to mandated services was against my philosophy had no concern to the powers that ran, and probably still run that health care behemoth, so, instead of having a negative comment on my NPDB record as I would have been fired, I resigned.

    And they are still looking for psychiatrists at that clinic 5 years later. Oh well, sorry for the patients, but, for the monolith that metastasizes onwards into the community, no, no concerns for them.

    Mandated care is a loser even more than random chance statistics could say otherwise. Oh, and pay attention to who demands the mandated services, these losers are often NOT participating in exactly what they demand of the public…

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