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Special Communication |

Guest Authorship and Ghostwriting in Publications Related to Rofecoxib:  A Case Study of Industry Documents From Rofecoxib Litigation

Joseph S. Ross, MD, MHS; Kevin P. Hill, MD, MHS; David S. Egilman, MD, MPH; Harlan M. Krumholz, MD, SM
JAMA. 2008;299(15):1800-1812. doi:10.1001/jama.299.15.1800.
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Context Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation.

Objective To characterize different types and the extent of guest authorship and ghostwriting in 1 case study.

Data Sources Court documents originally obtained during litigation related to rofecoxib against Merck & Co Inc. Documents were created predominantly between 1996 and 2004. In addition, publicly available articles related to rofecoxib identified via MEDLINE.

Data Extraction All documents were reviewed by one author, with selected review by coauthors, using an iterative process of review, discussion, and rereview of documents to identify information related to guest authorship or ghostwriting.

Data Synthesis Approximately 250 documents were relevant to our review. For the publication of clinical trials, documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation. Among 96 relevant published articles, we found that 92% (22 of 24) of clinical trial articles published a disclosure of Merck's financial support, but only 50% (36 of 72) of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company.

Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.

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Figure 1. Document and Manuscript Identification Flowchart
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See the “Methods” section for detailed descriptions of the search terms and the number of documents searched and for the definition of “related to or discussed authorship.”
aIdentification of these manuscripts does not imply that each was guest authored or ghostwritten; we examined these manuscripts because we believed their discussion within internal documents (or the discussion of specific authors) suggested that Merck was aware of the publication and perhaps had provided support for the project.

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Figure 2. Draft Version and Final Version of Article Describing the Results of Protocol 078
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Figure 3. October 2000 Letter From Representatives of Scientific Therapeutics Information Inc (Grace E. Johnson, Una Kistner, John Romankiewicz) to Merck & Co Inc (Deborah Matzura-Wolfe, Greg Geba) Discussing the Completion of the First Draft of a Contracted Manuscript Related to Rofecoxib
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Figure 4. October 1999 E-mail Between Representatives of Scientific Therapeutics Information Inc and Merck & Co Inc Discussing Contracted Publications Related to Rofecoxib
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Review articles were identified by 7 of 8 investigators listed above, several with titles nearly exactly as proposed. Intended author names have been blacked out because articles were not identified by all named investigators.

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Figure 5. Health Science Communications Inc Contract to Provide One 20-Page Review Manuscript With 6 Figures or Tables Intended for a Cardiology Audience for Merck & Co Inc at a Cost of $23 841.00
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