before doing it…

Posted on Wednesday 6 June 2012

I was just sent this article, short but so clear. Clarity comes best from afar, and this paper is by watchers with an appropriate distance:
Medical Ghostwriting: A University–Sanctioned Sleight of Hand?
Society
by Jonathan Leo & Jeffrey R. Lacasse
May 2012

As we examined the results of the investigation, we were struck by the fact that the investigative panel seemed to confuse honorary authorship with ghostwriting. To be sure, both are problems in academia, but there are important differences. Honorary authorship consists of someone being placed on the authorship line who did not truly deserve to be listed as an author- often a department head or wellrespected senior researcher in the field. As we have recently argued, ghostwriting is a simpler issue to ascertain, by asking the straightforward question: Was there a writer who contributed significantly to the paper, who was not listed as an author? If the answer is yes, the paper was ghostwritten. This is not just our perspective. In a recent research article on ghostwriting, the editors of JAMA defined a paper as ghostwritten when, “An individual who was not listed as an author made contributions that merited authorship,” or “An unnamed individual participated in writing the article”…
    "Honorary authorship consists of someone being placed on the authorship line who did not truly deserve to be listed as an author…"

    "Was there a writer who contributed significantly to the paper, who was not listed as an author? If the answer is yes, the paper was ghostwritten."
What could be clearer? At issue is why don’t we simply look at these two things when reviewing a paper or vetting a previous publication? It seems so simple. One reason we don’t do that is that the honorary authors want full billing and the ghost-writers don’t. These discussions always come later, after the article is published, and then the rationalizations begin to fly. The classic is the cross examination of Sally Laden on the stand concerning the Study 329 article:

    GSK LAWYER: But do you consider that the work that you did in terms of revising the draft of the article to incorporate the authors comments their analysis and their changes, Is that a host of hours in your mind?
    SALLY LADEN: It was a lot of time.
    GSK LAWYER: If STI or you had ghost written the Keller article would you have then would there have been any need to do any of this work that we have been discussing?
    SALLY LADEN: Can you tell me what you mean by ghost written?
    GSK LAWYER: Ghost written is where the authors of the article have no input at all into the contents of the article.
    SALLY LADEN: And then can you repeat the question please?
    GSK LAWYER: With that identification of ghost writing in mind If STI or you had ghost written the Keller article would there have been any need to do any of the items that we discussed in terms of your editorial assistance?
    SALLY LADEN: That’s a hard question to answer because that didn’t happen.
    GSK LAWYER: Is it your testimony that you did not ghost Study 329 well excuse me Is it your testimony that you did not ghost write the Keller article which was published in the journal of the American Academy of Child and Adolescent Psychiatry?
    SALLY LADEN: Based on your definition of ghost writing – absolutely.
    GSK LAWYER: Would you have bothered to waste your time your effort and your energy doing all of this coordination with the authors if you were a ghost writer for the Keller article?
    SALLY LADEN: I can’t answer that.
    GSK LAWYER: Why can’t you answer that?
    SALLY LADEN: Because I don’t believe I was a ghost writer.
Her lawyer defines ghost-writing for her in a way she can deny it. And that’s the way it seems to always go. The initial article above is actually about the silly decision of the University of Pennsylvania about a 2001 Sally Laden production, Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression [see closer to becoming indelible…]. So even those very clear definitions are game for nit-picking after the fact. And speaking of absurd:
This leads to many implications for both academic research and the education of aspiring health professionals such as physicians and nurses. In terms of research, it is obvious that there are an undetermined (but large) number of ghostwritten papers in the peer-reviewed medical literature. Systematic reviews and meta-analyses of topics where pharmaceutical companies have a stake need to be reexamined with this in mind. There is currently no mechanism in place for handling known ghostwritten papers, and many continue to be cited favorably. Academia might also rethink the perception of pharmaceutical industry-affiliated professors far from retirement who already have nearly 1,000 publications on their curricula vitae. Rather than regarding them as luminaries, we might wonder how many of their publications are ghostwritten, especially in the 1990s and 2000s when, according to the UPenn investigation, policies were not in place to prevent ghostwriting…
    "Academia might also rethink the perception of pharmaceutical industry-affiliated professors far from retirement who already have nearly 1,000 publications on their curricula vitae. Rather than regarding them as luminaries, we might wonder how many of their publications are ghostwritten, especially in the 1990s and 2000s…"
Acknowledge the mentors and advisers in the Acknowledge-ments, not the byline. These Charlie-NemeroffJohn-RushMichael-Thase  mega CVs are an embarrassment to the profession. Real academic scholars don’t do that, piggy-back their names onto the articles of their students or faculty members. None of us believe that Charlie Nemeroff has written or even been involved in writing 651 articles. Any real mentor or chairman wouldn’t want to get in the way of a young up-and-comer who had sweated over some scientific article. It serves no real purpose, even for the senior signer-oners. It just makes people feel like they’re insecure.

But I think the biggest point here is that the true "authorship" needs to be determined before an article is published. And the "honor system" hasn’t worked. My solution would be simple. In scientific studies and clinical trials, the primary outcome variables need to be declared before doing the study. Why not require the same thing of authors? – declare the primary [first] author for any clinical trial or grant supported study before doing it. If something happens along the way, there could be a protocol for changing in midstream if need be. File first drafts publicly. Put anyone not directly involved in the study or its writing in the acknowledgements. For non-grant supported studies, send documentation of involvement with the initial submission.

It may seem like a lot of trouble to go to, but given the magnitude of the problem – it’s the right thing to do. We never need to see this kind of thing again:
Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial
by MARTIN B. KELLER, M.D., NEAL D. RYAN, M.D., MICHAEL STROBER, PH.D., RACHEL G. KLEIN, PH.D., STAN P. KUTCHER, M.D., BORIS BIRMAHER, M.D., OWEN R. HAGINO, M.D., HAROLD KOPLEWICZ, M.D., GABRIELLE A. CARLSON, M.D., GREGORY N. CLARKE, PH.D., GRAHAM J. EMSLIE, M.D., DAVID FEINBERG, M.D., BARBARA GELLER, M.D., VIVEK KUSUMAKAR, M.D., GEORGE PAPATHEODOROU, M.D., WILLIAM H. SACK, M.D., MICHAEL SWEENEY, PH.D., KAREN DINEEN WAGNER, M.D., PH.D., ELIZABETH B. WELLER, M.D., NANCY C. WINTERS, M.D., ROSEMARY OAKES, M.S., AND JAMES P. MCCAFFERTY, B.S.
Journal of the American Academy of Child and Adolescent Psychiatry, 2001, 40(7):762–772.
It should simply say:
Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial
by Sally Laden & Martin B. Keller
Journal of the American Academy of Child and Adolescent Psychiatry, 2001, 40(7):762–772.
  1.  
    June 7, 2012 | 3:25 PM
     

    With so many “authors” Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial looks like the result of a parlor game.

  2.  
    June 7, 2012 | 8:08 PM
     

    It looks like there was a big pot of money and co-authors were eager to sign on so they could dip into it.

  3.  
    Anonymous
    June 17, 2012 | 2:34 PM
     

    Nemeroff’s current vita, at the University of Miami, lists 956 articles, not including books, book chapters, etc.

    https://umshare.miami.edu/web/wda/facultysenate/11-12GWC/January/DFSA/CharlesNemeroff.pdf

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