Tuesday, August 26, 2008

No Denying the Haunting of the Medical Literature

There was a remarkable series of letters in the latest JAMA(1). They, in turn, were responses to an article by Ross et al about ghost and guest authorship of articles about rofecoxib [Vioxx, by Merck](2). (See our post about that article here.)

Two of the letters were notable because they came from the lead authors of articles that Ross et al described as ghost-written.

First was a letter by Hawkey, which said in part,

From my own publications, I was surprised to see references 79, 94, 96 and 108 as having been in a Merck publication status report since these were reviews independently invited by Lancet, Balliere, Gastroenterology Clinics of North America, and Gut respectively, and involved no contact with Merck beyond usual request for all relevant sources for information.

Second was a letter by Ferris, Galasko, and Kirby, which said in part, (referring to an article by Thal et al discussed by Ross et al)

The 3 alleged guests in fact played substantial roles: conceiving and designing the study (Thal), confirming accuracy of the primary study end point as a member of the end point adjudication committee (Ferris), and enrolling 109 patient (Kirby). The paper was initially drafted by Merck coauthors in August 2003, after discussion of the results had previously taken place with Dr Thal and Dr Ferris in June and July of 2003. Drs Thal, Ferris, and Kirby were formally approached about being coauthors on the paper and an associated abstract in September 2003. Each critically reviewed the complete statistical report and contributed to the revising the final manuscript.

Before I go further, let me say a little about how scholarly articles are customarily written when no guest and ghost authors are involved. For all the articles I have authored, the first author was the researcher who was in charge of the overall study, or at least was substantially in charge of the study component reported by the article. The first author always wrote the first draft of the manuscript, possibly getting help from other authors or medical writers, but always being overall in charge. The first author always took responsibility for the final draft and published version of the manuscript. The second and third authors were generally those most involved with the relevant project, and with rewriting the manuscript.

This process seems very different than that used to write the articles discussed above.

Note that neither Hawkey nor Ferris, Galasko and Kirby claimed to be the principal investigators of the relevant projects, to have written the first drafts of the manuscripts, or to be those with the final say on the final drafts or published versions of the manuscript. Furthermore, none denied that Merck authors wrote the first drafts of the relevant manuscripts or that Merck authors had substantial responsibility for the content of the published papers. Hawkey claimed to have had "little contact" with Merck, but that did not preclude Merck authors from writing the first draft, or taking substantial responsibility for the content of the manuscript. Ferris, Galasko and Kirby claimed to have had some roles within the research project, but did not individually or collectively claim to be the project's principal investigator or to be substantially iin charge of the project, and did not deny that Merck authors wrote the first draft and took substantial responsibility for the content of the manuscript.

Thus, these letter writers did not deny that they had failed to do the work and take the responsibilities normally entailed by first authorship of scholarly manuscripts. Nor did they provide any evidence that the claims made by Ross et al about the ghost authorship of their papers were incorrect.

On the other hand, Hawkey and Ferris, Galasko and Kirby did take the opportunity to fulminate about the original JAMA article. Hawkey criticized Ross et al for failing to "systematically evaluate" all the articles in their Table. Ferris, Galasko and Kirby decried "this unsubstantiated allegation of guest authorship" which raised "questions about the flawed methodology in the study by Ross et al."

It is ironic that the financial disclosures for the letters by Hawkey, and by Ferris, Galasko and Kirby used 24 lines of type. Dr Ferris alone disclosed being a former or current consultant to 32 pharmaceutical, biotechnology or similar corporations.

What is most troubling, in my humble opinion, about the letters discussed above is that their authors could not bring themselves to directly address the core issue raised by Ross et al: evidence that they used their good names and academic reputations to cloak articles generated for commercial purposes in the guise of scholarship.

The larger questions are: how much of the clinical research database and the body of scholarship on which physicians and patients base their decisions was commercially generated, but deceptively promoted as produced by academics only interested in the discovery and dissemination of the truth? Furthermore, how many respected academics have built their careers and reputations on the work of unnamed employees of commercial health care firms, and thus what should we make of their supposed scholarship? And finally, on a personal note, how many honest academics have been crowded out of the competition for the support and dissemination of their work by faux scholars who claimed as theirs work done by others for commercial purposes?

As was said on the PharmGossip blog, it may be time for a truth and reconciliation committee that will allow us to put these deceptive ways behind us. To better care for patients and better advance science, we need medical scientists who put allegiance to the truth ahead of allegiance to their personal financial gain.

ADDENDUM (27 August, 2008) - See also comments on Science-Based Medicine blog.

ADDENDUM (2 September, 2008) - See also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.


1. Guest authorship, mortality reporting, and integrity in rofecoxib studies. JAMA 2008; 300: 900-906. [Link here.]

2. Ross JS, Hill KP, Egilman DS, Krumholz HM. Ghost authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008; 299: 1800-1812. [Link

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