great job!…

Posted on Wednesday 26 January 2011

The war of words over POGO’s letter to Dr. Francis Collins concerning "ghostwriting" continues [a “quintessential resource”…roaches…, when charlie met sally…]. Dr. Schatzberg’s lawyer continues to pick at POGO, asking them to withdraw the allegation that Drs. Nemeroff and Schatzberg published a book, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care, that was a production of GlaxoSmithKlein by their paid writing firm Scientific Therapeutics Information. They’ve mounted a noisy defense with many letters to the POGO lawyer and two publications, one from the APA and another from the APPI [publisher]. As for this STI letter [below], they’ve simply discounted it [Schatzberg says he never saw it and it was never put into action anyway]. None of these defenses are up to the challenge. Nemeroff and STI are already busted in other cases, lots of other cases, and the APA and APPI are hardly credible defenders, being the connections Nemeroff and Schatzberg both have with them.

What’s fascinating is that both Schatzberg and Nemeroff think they have been cleared of wrongdoing in the investigations done by Senator Grassley assisted by Paul Thacker. While it’s true that Emory and Stanford didn’t lower the boom entirely, to me that says more about Emory and Stanford than about the innocence of these two former Chairmen. In his last nasty-gram, Schatzberg’s lawyer ends with:


Those "documents about irrelevant events that occurred over a decade ago" are listed in POGO’s last response.

At issue, does "Dr. Schatzberg will not dignify POGO’s ghostwriting accusations by spending more time  and money on a word counting exercise …" mean that he’s dropping the matter? or does it mean that he’s going to sue POGO for defaming him? I’m betting on the former but sort of hoping for the latter because I’d love to see all of those documents POGO would surely request in discovery. I would be mighty surprised if the silent partner in all of this, GlaxoSmithKlein would like its dirty laundry spread out in court documents, particularly after GSK President Deirdre Connelly’s recent speech [“so what went wrong?”…].

Somewhere above the tit-for-tat going on in this case, there seems to me a legitimate question involved about what constitutes ghostwriting. In June 2010, Senator Grassley reseased his report [Ghostwriting in Medical Literature]. In that Report, it says:

About two years ago, Senator Grassley inquired about an industry practice to get articles published in major medical journals touting the benefits of a company’s product without public disclosure that the company initiated and paid for the development of the articles. Specifically, Senator Grassley wrote to Merck & Co., Inc. (Merck) and Scientific Therapeutics Information (STI), a medical publishing company, following the publication of a study in the Journal of the American Medical Association (JAMA). In that study the authors examined Merck’s manipulation of scientific literature through ghost writers to market the painkiller Vioxx. Notably, based on their review of court documents the authors of the JAMA article concluded that “review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.”

Medical ghostwriting is a practice where pharmaceutical or device companies hire medical education, marketing or communications companies to draft articles that are presented to prominent physicians and scientists to sign on as authors to increase the likelihood that the article will be published in important medical journals. Ghostwritten articles include articles that are drafted by pharmaceutical or device company employees who are not acknowledged in the final publication. The articles may be review articles, editorials or primary research papers, and they are typically presented to physicians and scientists affiliated with academic institutions. The physicians and scientists agree to sign on even if they may not be intimately familiar with the underlying data or relevant research or provided limited input on the article. Authors who make little to no contribution to a publication are also referred to as “guest” authors.

Senator Grassley’s investigation was sparked by the famous 2008 case of Merck’s Drug Vioxx™ – an egregious case that fits the strict scenario described in the second paragraph above. In that case, the pharmaceutical company contracted to have the articles written by STI, then authors were engaged to legitimize the publication – a worse case scenario. Drs. Nemeroff and Schatzberg are responding as if that’s all ghostwriting is, thus their insistance that since the book was their idea and that they participated ["marginalia" edits], it wasn’t ghostwritten. The POGO letter to the NIH is operating on a much broader definition of ghostwriting, one that most critics of the book share, myself included. Here’s the more rigorous definition [listed in the POGO references]:
Ghostwriting at Elite Academic Medical Centers in the United States
PLoS Medicine [Public Library of Science]

by Jeffrey R. Lacasse and Jonathan Leo
February  2, 2010

… All listed authors on a publication must meet the authorship criteria set by the International Committee of Medical Journal Editors. Making minor revisions to a manuscript does not qualify as authorship. Participating in the creation of ghost-authored manuscripts is not permitted. A ghost author is defined as someone who makes substantial contributions to writing a publication but is not listed as an author. All individuals who have made a substantial contribution to the manuscript must be listed as authors. Accurately reporting authorship is essential for maintaining research integrity, and violating any of these rules is considered research misconduct akin to plagiarism or falsification of data.

At the institutional level, vigorous enforcement efforts should accompany the implementation of such policies. Administrators should carefully monitor the medical literature for clues of ghostwriting, such as an acknowledgment of a medical writer’s assistance in a peer-reviewed journal article. When a medical writer is thanked, this will be taken to mean that they do not qualify for authorship, much in the way that a copyeditor does not receive a byline credit. At present, such acknowledgments are suspected to mean that the medical writer actually ghostwrote the paper, but the implementation of a stringent ghostwriting policy will require strict accuracy on this issue. When there is doubt, aggressive investigative action should be taken. The empirical findings of medical literature are unlikely to change, but reports of authorship would thus be honest and transparent.

Acknowledging ghostwriters does not accurately reflect their authorship role [see original].

When it comes to light that an academic has violated this policy, rapid disciplinary action should result. Sanctions should be equivalent to those used in cases of plagiarism or falsification of data. When a behavior poses a significant public health risk, most governments punish such behavior vigorously. For instance, most governments heavily penalize people who drive an automobile while intoxicated; the goal is to protect the public by deterring the behavior. Similarly, it is hard to envision a policy that protects the public from ghostwriting without punishing the behavior.
Those of us who follow such matters are incredulous that Drs. Nemeroff and Schatzberg would even argue with the POGO letter, particularly Dr. Nemeroff given his very public misadventures. However, the comment in Dr. Schatzberg’s response, "documents about irrelevant events that occurred over a decade ago" deserves a hearing. A decade ago, it would never have even occurred to me, or most of us, that a medical textbook or an article in a peer reviewed medical journal might have been authored even in part by a professional writer or sponsored by a pharmaceutical company in any way. As I said before, those were sacred texts. In the intervening years, we’ve learned otherwise. We’ve learned much more than we ever wanted to imagine. I still pinch myself to believe the practice is as widespread as it seems to have become. So POGO wrote the Director of the NIH urging the adoption of a policy similar to the one proposed by Lacasse and Leo above for all academics and academic institutions receiving NIH funding.

The author, Paul Thacker, Senator Grassley’s former investigative assistant, used the texbook in question as an example. It’s a good one. As they say, "When a medical writer is thanked, this will be taken to mean that they do not qualify for authorship, much in the way that a copyeditor does not receive a byline credit. At present, such acknowledgments are suspected to mean that the medical writer actually ghostwrote the paper, but the implementation of a stringent ghostwriting policy will require strict accuracy on this issue." It is exactly what Schatzberg refers to as "documents about irrelevant events that occurred over a decade ago" that have lead us to today, and to the urgent call for reform.

This really isn’t about these two men unless they insist on continuing to make it about them. Their time has come and gone. It’s about plugging a very large hole in the firewall between ethical academic science and marketing by companies with products to sell. One would’ve thought that the firewall was sacrosanct, but that clearly wasn’t the case. The ball is in Dr. Francis Collins court now, and, thus far, I am not aware of his response. As for POGO and Paul Thacker, great job!

Senator Grassley’s June 24, 2010 letter to Dr. Collins of the NIH on this same topic is here.
    January 26, 2011 | 11:47 PM

    And a “great job” by you, too, Mickey, for putting all this together for those of us who wouldn’t know about all this otherwise.

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