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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.

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.

Author Affiliations: Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, New York (Dr Ross); Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, and McLean Hospital, Belmont, Massachusetts (Dr Hill); Department of Community Health, Brown University School of Medicine, Providence, Rhode Island (Dr Egilman); and Robert Wood Johnson Clinical Scholars Program and Section of Cardiovascular Medicine, Department of Medicine, Section of Health Policy and Administration, School of Public Health, Yale University School of Medicine, and Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut (Dr Krumholz).

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