when charlie met sally…

Posted on Friday 21 January 2011

I thought I could put Drs. Schatzberg and Nemeroff on the side for a while after a few days with Corcept, but up they bounced when I read the article below. I’ll have to admit, it’s a classic. Remember back in late November, POGO wrote a letter to Dr. Francis Collins, Director of the NIH, about ghostwriting. One of their examples was a textbook by Nemeroff and Schatzberg written in 1997 [see roaches...]. Well they went ballistic at being accused of ghostwriting and lawyered up. It was all kind of silly because POGO’s evidence was in the range of incontrovertible. But the duo just keeps picking and picking:
I guess POGO author Paul Thacker hit a nerve. First, the American Psychiatric Association issued an immediate supporting Press Release for them. Now, the the American Psychiatric Publishing Inc. is providing evidence [well, sort of...]:
APPI Documents Refute Claims About Text’s Authorship
Galleys and manuscript proofs stored in files of American Psychiatric Publishing Inc. provide clear proof of active author involvement in the development of the text throughout all of its iterations.
Psychiatric News

by Mark Moran
January 21, 2011

APA is protesting allegations that a 1999 book published by American Psychiatric Publishing Inc. on psychotropic prescribing for primary care physicians was ghostwritten, but significant aspects of the allegation—published by the New York Times on November 29, 2010—have since been retracted and corrected by the newspaper…

In a joint statement to Psychiatric News, Nemeroff and Schatzberg emphasized that STI had an unrestricted grant from SmithKline Beecham and was in no way working for the drug company. “SKB did not write the book nor was STI hired by SKB to work on it,” the authors said. “The article indicates the company gave an unrestricted grant to STI, and that was confirmed independently by a SKB spokesperson. Thus the [original] headline comports neither with the reality nor the article.”

They added, “In all branches of academic medicine, graduate students, research assistants, fellows, and others contribute in various ways to scientific manuscripts. Their contributions are recognized as either co-authors or in the acknowledgements for their technical or other assistance. Over the last decade, guidelines for authorship have evolved but were certainly not as well established in 1997 as they are today, when this project was initiated. Nevertheless, appropriate credit to the STI staff was provided. It is also important to note that we were not remunerated by SKB for any of this work. Our desire to educate primary care physicians led us to convince SKB to provide an unrestricted educational grant for editorial assistance and to distribute the primer to family doctors.”

In an interview with Psychiatric News, McMillen said that APPI has extensive files, proofs, and manuscript versions of the book that clearly demonstrate the active involvement of Schatzberg and Nemeroff in every stage of the book’s development. “I’ve seen the files, and you can clearly see author involvement,” he said. “Schatzberg and Nemeroff have margin notes in all of the galleys with their initials throughout all of the various iterations. We also had the book peer reviewed by more people than is routine. The peer-review comments were sent to [STI], and every single one of them was incorporated. The writer for STI was clearly working for us. “To call that ghostwritten is just absurd,” McMillen said.
This story is older that just a month or so. As far back as 1993, Sally Laden of STI was involved with Dr. Nemeroff, coordinating his moderation of the SKB Medical Advisory Board meeting after Paxil was put on the market. Much later, in 2006, Charlie was busted for writing an article in Neuropsychopharmacology [a journal he edited], that favorably reviewed the Cyberonics Vagus Nerve Stimulator [for depression] without disclosing his financial connections with the company. He lost his editorship in disgrace [Journal Editor Quits Over Conflict of Interest]. And there was Sally, still with him. In that article:
At that time, the Healthcare Renewal blog had this to say:
…In presenting this summary, the review carefully followed the corporation’s marketing message and branding language. There is no discernible difference between the corporation’s press releases and the text of the review article on these topics. The review did not address the controversy surrounding the FDA approval process. In these respects, the review has the hallmarks of a ghostwritten article. As described by Leemon McHenry, who has written on conflict of interest issues in medicine, "I have … seen contracts between the pharmaceutical companies and the ghostwriting companies with the plan of production and the budget. What is particularly interesting about these is the fact that it is clear that the company owns the manuscript until it is released to the "authors." The company’s legal department reviews the manuscript and releases it at the end of the process. The first draft isn’t even reviewed by the "authors." This is all internal until the second draft." It appears very likely that the VNS review was carefully screened by the corporation to ensure that the first draft was "on message" before being released to the "authors" for them to strengthen the hard science surrounding the stealth infomercial…

…the article acknowledged "editorial support" from a professional writer, who acknowledged to the Wall Street Journal that she was employed by the corporation for the task of writing a first draft. Although the authors claimed they provided substantive input after the first draft, it is ethically dubious to use a hired writer for a first draft.
So now to the textbook in question, the 1997  Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care by Drs. Nemeroff and Schatzberg. The correspondence between Dr. Nemeroff and Sally Laden is clear as a bell. And the authors say this in the Forward to the book:
 
So, in the 2006 example, what does "editorial support in developing early drafts" even mean? It’s backwards. What’s to edit when there’s nothing yet there? That makes no sense. And in the example of the 1997 book, the letter from STI provided by POGO is a schedule of drafts and when the authors will get to see them. There’s a good example of such a contract from the  Martin Keller/Paxil Study 329 case here [Sally Laden of STI once again]. Both follow the pattern described in the Healthcare Renewal Post mentioned above [ Money and Medical Journals]:
As described by Leemon McHenry, who has written on conflict of interest issues in medicine, ‘I have … seen contracts between the pharmaceutical companies and the ghostwriting companies with the plan of production and the budget. What is particularly interesting about these is the fact that it is clear that the company owns the manuscript until it is released to the authors. The company’s legal department reviews the manuscript and releases it at the end of the process. The first draft isn’t even reviewed by the authors. This is all internal until the second draft.’ It appears very likely that the VNS review was carefully screened by the corporation to ensure that the first draft was ‘on message’ before being released to the authors for them to strengthen the hard science surrounding the stealth infomercial."
The APPI article in the Psychiatric News [above] defends Dr. Schatzberg and Nemeroff saying:
In an interview with the Psychiatric News, McMillen said that APPI has extensive files, proofs, and manuscript versions of the book that clearly demonstrate the active involvement of Schatzberg and Nemeroff in every stage of the book’s development. “I’ve seen the files, and you can clearly see author involvement,” he said. 
My point is obvious. Of course the authors wrote in the margins! Of course they were involved! That’s what the authors are for: to add their names and "to strengthen the hard science surrounding the stealth infomercial." What a strange world it is where evidence of "author involvement" is considered a defense against ghostwriting. Anything less wouldn’t be ghostwriting, it would be plagiarism. The APPI evidence is actually closer to an indictment than a defense.

I honestly hope that Schatzberg and Nemeroff push this into a courtroom [not that I wish it on POGO to have to bear the hassle and the expense]. But I’d love to see those documents  with the marginalia, and I’d love to read a deposition from the ever elusive Sally Laden. Those endless explanations and excuses these two men have rolled out with each infraction are the kinds of things kids say when they didn’t do their homework. A decent lawyer will make mincemeat out of them in a blue second. Initialed notes in the marginalia is hardly a viable defense if it’s somebody else’s margin. And this notion of "unrestricted educational grant" as a defense against Conflicts of Interest won’t fly with any Jury that’s alert and awake.

Truth be told, ghost-writing usually refers to someone who is good at writing taking ideas from the supposed author and turning them into an acceptable literary production. What has probably happened in a lot of these medical articles and books is that the writer has taken the message from a sponsor, put it into a readable form, and the supposed author then adds the science that legitimizes the endeavor. So there are two ghosts involved. I guess it’s ghostswriting.
  1.  
    Carl
    January 21, 2011 | 11:06 PM
     

    Indeed, there is fundamental moral dilemma here that is different than some famous person who couldn’t hardly write their own name issuing their autobiography “with” (someone who can write). What seems to be going on here is that the M.D. (eitys) Nemeroff, Schatzberg et.al., lend their positional and reputational imprimaturs to shills who can write stuff that makes gladsome news for the executives and shareholders of the corporation. In many circles, they all be hoes, after a fashion. It’s enough to turn a fellow into a raving liberal.

  2.  
    Ivan the Terrible
    January 22, 2011 | 8:03 AM
     

    Notice how the pushback is coming from the players who stand to lose face – the ‘authors’ Nemeroff and Schatzberg plus the APA. The commercial actors STI and SKB (now GSK) are keeping their heads down.

    The key information that is being carefully guarded is the actual contract between SKB and STI. Why do Nemeroff, Schatzberg and APA not make that public, so we can all see exactly how much control SKB had over this book? That will tell us more than marginal notes on made for hire drafts.

  3.  
    January 22, 2011 | 8:30 AM
     

    STI and GSK lurking in the shadows is the biggest point of all. That’s why I’d love to see this case in court with subpoenas and depositions. It would strip away Charlie and Alan’s chronic excuses, like a parent-teacher conference lowers the boom on a chronic homework loser. I expect POGO’s up to the task…

  4.  
    Bernard Carroll
    January 22, 2011 | 1:26 PM
     

    Yes, I agree with you and Ivan. The APA’s front man McMillen cannot be serious in claiming that Nemeroff and Schatzberg were actively involved “in every stage of the book’s development.” Notice, he doesn’t dare to say they wrote the first drafts of any chapters.

    We have here one of those dual perspective gestalts. Most people see immediately that Nemeroff and Schatzberg did some editing of drafts written by Dianne Coniglio and Sally Laden. The APA and the ‘authors’ want us to believe it’s theother way around. Whose cognitive performance would you guess is biased?

  5.  
    shocked... shocked I say
    January 22, 2011 | 5:56 PM
     

    Pay close attention to this from Nemeroff and Schatzberg in the latest APA defense: “It is also important to note that we were not remunerated by SKB for any of this work.” Their lips are sealed about remuneration from STI. That would be a straightforward case of money laundering.

  6.  
    Stan
    January 24, 2011 | 8:34 PM
     

    Nemeroff was big time financially vested in Cyberonics (AKA – VNS). The more you dig into this hole, the dirtier & uglier this gets…..

  7.  
    July 27, 2011 | 9:47 AM
     

    [...] allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison [...]

  8.  
    August 6, 2011 | 7:27 AM
     

    [...] allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison Bass. The APA and its publishing arm, known as American Psychiatric [...]

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