Healthy Skepticism Library item: 13535

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Ross JS, Hill KP, Egilman DS, Krumholz HM.
Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation.
JAMA 2008 Apr 16; 299:(15):1800-12
http://jama.ama-assn.org/cgi/content/full/299/15/1800

Abstract:

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.

Keywords:
Authorship* Biomedical Research*/ethics Biomedical Research*/legislation & jurisprudence Biomedical Research*/standards Biomedical Research*/trends Clinical Trials as Topic Cyclooxygenase 2 Inhibitors* Disclosure Drug Industry*/ethics Drug Industry*/legislation & jurisprudence Drug Industry*/standards Drug Industry*/trends Lactones* Publishing*/ethics Publishing*/legislation & jurisprudence Publishing*/standards Publishing*/trends Research Support as Topic Review Literature as Topic Sulfones*