1 Boring Old Man

• POGO’s first reply to letters from Dr. Schatzberg and Dr. Nemeroff, 12/08/2010.
• POGO’s second reply to letters from Dr. Schatzberg and Dr. Nemeroff, 12/09/2010.
• POGO’s third reply to letters from Dr. Schatzberg and Dr. Nemeroff, 12/16/2010.
• POGO’s fourth reply to letters from Dr. Schatzberg and Dr. Nemeroff, 12/23/2010.

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ghostwritten, but significant aspects of the allegation—published by the New York Times on November 29, 2010—have since been retracted and corrected by the newspaper…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.

…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.

 

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."

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. 

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.