I see dead people…

Posted on Wednesday 13 April 2011

John Romankiewicz, founder of Scientific Therapeutics Information [STI], isn’t having a very good week. His medical communications firm has been under the microscope in the matter of Charlie Nemeroff’s and Alan Shatzberg’s psychopharmacology textbook for Primary Care Physicians ever since POGO’s accusation that STI’s Sally Laden and Diane Coniglio ghost wrote the book. Monday, Phylis Vine found an old STI web-page proudly displaying the book [see my last post], going a long way towards invalidating the "authors"’ denials. Then Tuesday, POGO put up a transcript of Sally Laden’s deposition in a 2007 Paxil lawsuit against GSK involving another ghost writing allegation. When Ed Silverman of Pharmalot gave John Romankiewicz a call at STI to ask some questions, John was definitely in a grumpy mood:

    So we called John Romankiewicz, a PharmD who started the firm 26 years ago, to ask about the missing info. His explanation? “Thanks for the inquiry,” he responded abruptly, “but we don’t display that kind of stuff on our web site.” We replied by noting that the info had been there previously, but then we heard a loud…click. Perhaps, he realized that listing the book as a portfolio product does not easily square with the APA position that ghostwriting did not take place. And taking down the product portfolio might also make it more difficult to scrutinize other STI work. Given how fast he hung up, though, one might have thought we uttered the magic word: “Boo!”

If you’ve ever been deposed, you know the drill. A lawyer spends a few hours trying to turn you into a witness for the other side [in this case, 90 pdf pages]. Then your other team spends a few hours trying to undo any damage [another 75 pdf pages]. Since there’s no Judge around, all questions are the kind not allowed in a court room – "leading the witness." In those first 90 pages of Sally’s deposition, it was clear that GSK had sent their version of a study of Paxil treating adolescent depression to Sally Laden and she turned it into a first draft of a paper. It was also clear that GSK knew it was a "failed study" before they sent it. It was the article published under the "authorship" of Dr. Martin Keller [then Chairman at Brown Medical School] and others – the results of the infamous Study 329. That article was ultimately published in the Journal of the American Academy of Child & Adolescent & Psychiatry recommending Paxil for the treatment of Adolescent Depression.

Sally LadenThe plaintiff’s lawyer also established that Ms. Laden carried the article to completion, working with Dr. Keller’s edits and the complaints of various reviewers for journals that rejected the paper until she got it published. It was also obvious that she felt no responsibility for the content or conclusions. Her job was to get it written and get it published.

The lawyer for GSK then cross examined. He was trying to establish that Dr. Keller and the other "authors" were involved in the writing of later drafts [trying to distance GSK from "authorship"], and finally got around to the issue of ghost writing on pdf page 111. Here’s a [slightly cleaned up] version of that exchange:
    QUESTION: 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?
    THE WITNESS: It was a lot of time.
    QUESTION: 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?
    THE WITNESS: Can you tell me what you mean by ghost written?
    QUESTIONER: Ghost written is where the authors of the article have no input at all into the contents of the article.
    THE WITNESS: And then can you repeat the question please?
    QUESTION: 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?
    THE WITNESS: That’s a hard question to answer because that didn’t happen.
    QUESTION: 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?
    THE WITNESS: Based on your definition of ghost writing – absolutely.
    QUESTION: 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?
    THE WITNESS: I can’t answer that.
    QUESTION: Why can’t you answer that?
    THE WITNESS: Because I don’t believe I was a ghost writer.
Like Bruce Willis’ character in M. Night Shyamalan’s film, The Sixth Sense, the deposition raises the question, "Does a ghost know it’s a ghost?" Sally doesn’t believe she’s a ghost writer [she makes the lawyer define it before answering]. And that definition given by the lawyer sounds familiar, "Ghost written is where the authors of the article have no input at all into the contents of the article." It’s the argument of Shatzberg’s and Nemeroff’s lawyers in response to POGO’s challenge of their textbook, and it’s the essence of the APA’s response in their defense [APPI Documents Refute Claims About Text’s Authorship]. I’ve had my say about that argument previously [when charlie met sally…] and won’t repeat it here.Essentially, I think these examples are worse than ghost writing. But right now I want to avoid the lawyer’s semantic trap.

The Paxil suit and the textbook case are not exactly the same. In the case of Study 329, the Pharmaceutical Company hired STI and sent them a summary of the study [having privately seen it as a failed study]. Sally Laden  of STI wrote a first draft, then tweaked it with the recruited "authors’" input. It was published recommending Paxil as a treatment for depressed adolescents. In the case of Shatzberg and Nemeroff, they were the editors of a definitive Psychopharmacology text. In Sally’s letter to Dr. Nemeroff, it’s clear that GSK  [sponsor] is STI’s employer and a big part of the mix. There’s little question  about who’s writing the book:

 

And as Danny Carlat pointed out, there’s little question about its purpose [Nemeroff and Schatzberg’s “Textbook” Pushed Paxil]:
    To sum up, in 1999, Nemeroff and Schatzberg published a textbook called "Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care." It was funded by SmithKline Beecham with a $120,000 "unrestricted educational grant." Documents posted on the internet hint strongly that the book was ghostwritten by a PR firm hired by the drug company. And an analysis of the book’s content shows that it was crafted to encourage primary care doctors to prescribe Paxil preferentially over its competitors, such as Zoloft.
None of us agree with, "Ghost written is where the authors of the article have no input at all into the contents of the article," but who wants to waste time arguing semantics with a high-priced lawyer? Instead of nickle and diming over the precise definition of how to name these cases, it might be better to talk about what they don’t represent:
  • truth
  • integrity
  • ethically acceptable behavior
  • remotely acceptable behavior from physicians
  • remotely acceptable behavior from scientists
  • scientific knowledge
They are blatantly untruthful, unethical, perversions of science at its most basic level. Their only place in the medical literature is as examples of what not to do…
  1.  
    April 13, 2011 | 1:52 PM
     

    Hanging up on Ed Silverman displays guilt in my opinion, keep shedding light on this snake pit!!

    PS–the link to pharmalot is the pogo pdf file

Sorry, the comment form is closed at this time.