machiavellian medicine lives…

Posted on Wednesday 29 April 2015

I missed something. In the spice must flow…, I was looking at the two papers recently published about Brexpiprazole, a new Atypical Antipsychotic and found the the only academic authors were from the same faculty and research institute:
by Correll CU, Skuban A, Ouyang J, Hobart M, Pfister S, McQuade RD, Nyilas M, Carson WH, Sanchez R, and Eriksson H.
American Journal of Psychiatry. 2015 Apr 16 [Epub ahead of print]
by Kane JM, Skuban, Ouyang, Hobart, Pfister, McQuade, Nyilas, Carson, Sanchez, and Eriksson.
Schizophrenia Research. 2015 Feb 12. [Epub ahead of print]
Towards the end of writing that post, I looked up the chemical structures and realized what a clone Brexpiprazole was of Aripiprazole [Abilify®] [the number one overall seller in the US] that’s about to go off patent:
But something was nagging at me, and it just occurred to me what it was. A month and a half ago, I wrote a post about a CME for Aripiprazole [Long Acting Injectable] which is Abilify®Maintena [see a crying shame…] – which I saw as a patent-extender move now that Abilify® is going generic [analogous the same ploy with Seroquel®XR or Paxil®CR]. What I didn’t notice was the authorship on the Abilify®Maintena paper or the presenters of the CME.
by W. Wolfgang Fleischhacker, Raymond Sanchez, Pamela P. Perry, Na Jin, Timothy Peters-Strickland, Brian R. Johnson, Ross A. Baker, Anna Eramo, Robert D. McQuade, William H. Carson, David Walling and John M. Kane
The British Journal of Psychiatry. 2014 205:135–144.
This study was supported by Otsuka Pharmaceutical Commercialization, Inc. [Tokyo, Japan]. Editorial support for the preparation of this manuscript was provided by Suzanne Patel at Ogilvy Healthworld Medical Education and Amy Roth Shaberman, PhD, and Brett D. Mahon, PhD, at C4 MedSolutions, LLC, a CHC Group company; funding was provided by Otsuka Pharmaceutical Commercialization, Inc. and H. Lundbeck A/S.
The authors would like to thank Svetlana Ivanova, PhD, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, USA, for her contribution to the analysis and interpretation of data.
and [from a crying shame…]…
So we wonder who is on the faculty of this Free CME?  I clicked on the link to Adherence, Recovery, and the Role of LAIs in Schizophrenia:
  • Christoph U. Correll, MD
    Professor of Psychiatry and Molecular Medicine
    Hofstra North Shore – LIJ School of Medicine
    Medical Director of Recognition and Prevention (RAP) Program
    The Zucker Hillside Hospital
    Glen Oaks, NY
  • John M. Kane, MD
    Professor of Psychiatry
    Hofstra North Shore – LIJ Health System School of Medicine
    Vice President
    Behavioral Health Services of the North Shore – LIJ Health System
    Chairman of Department of Psychiatry and Chief of Staff
    The Zucker Hillside Hospital
    Glen Oaks, New York
  • John Lauriello, MD
    Chancellor’s Chair of Excellence in Psychiatry
    Executive Medical Director of the Missouri Psychiatric Center
    School of Medicine, University of Missouri Health System
    Columbia, MO
Take a look at the Learning Objective and guess what you’re going to learn – for free. Oh by the way, John Lauriello, MD is the senior author of a glowing handout review of Abilify®Maintena.
Familiar? All the authors in blue are Lundbeck or Otsuka employees. The three academic authors are all on Bureaus or Boards for both Lundbeck or Otsuka. John Kane, listed as senior author wrote was a listed author on one of the Brexpiprazole papers and is on Bureaus or Boards for both Lundbeck or Otsuka. And the Abilify®Maintena CME has both of the Academic Authors from the Brexpiprazole papers on the faculty.

In the spice must flow…, I joked "[it was one·stop shopping for both ghost·writers and KOLs]," but it was bigger than I knew. The Hofstra faculty provided not only authors for both Brexpiprazole  papers, but also the Abilify®Maintena paper  and the Abilify®Maintena CME – all of which were aimed at holding onto the market as Abilify® becomes generic. This was one·stop shopping-maximus [though Abilify®Maintena did get different ghost-writers]. The Abilify®Maintena study had 98 sites!

Lest  you’re getting excited about all the reforms, this is Academic·Industrial·Complex all the way – complete with KOLs, ghost-writers, CRO-style Trial with many sites and foreign sites, industry stats, ignoring the results database, COI everywhere you turn, commercial rather than scientific motives [replacing Abilify® as a cash cow], no primary data posted, etc.:

  • Guest Authors: In this case, the articles are no longer crammed with academics like a decade ago. I guess it only takes one to be the ticket into an academic journal. In this case, the main authors came from Hostra [The Feinstein Institute] for the articles and C.M.E. Their C.V.s and C.O.I. are heavily weighted with Clinical Trials of drugs.
  • Ghost-Writers: All articles had the characteristic writing/editorial support usually indicating the paper being ghost-written [and some ghost-statisticians].
  • Multiple International sites [60+57+98=215] and large subject cohorts [636+674+662=1972; 1972÷215=~9 subjects/site] ["fast" "sensitive" trials].
  • Selective Presentation: eg effect sizes reported in Correll et al [high] but not Kane et al [low].
  • Results Database on Missing in Correll et al and Kane et al.
  • And: a bunch of stuff I can’t see through the haze…
Machiavellian Medicine at its finest…

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