Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation - PubMed (original) (raw)
Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation
Joseph S Ross et al. JAMA. 2008.
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.
Comment in
- Impugning the integrity of medical science: the adverse effects of industry influence.
DeAngelis CD, Fontanarosa PB. DeAngelis CD, et al. JAMA. 2008 Apr 16;299(15):1833-5. doi: 10.1001/jama.299.15.1833. JAMA. 2008. PMID: 18413880 No abstract available. - How to ensure our readers' trust: the proper attribution of authors and contributors.
Liesegang TJ, Albert DM, Schachat AP. Liesegang TJ, et al. Am J Ophthalmol. 2008 Sep;146(3):337-40. doi: 10.1016/j.ajo.2008.06.007. Am J Ophthalmol. 2008. PMID: 18724976 No abstract available. - Guest authorship, mortality reporting, and integrity in rofecoxib studies.
FitzGerald GA. FitzGerald GA. JAMA. 2008 Aug 27;300(8):900-1; author reply 904-5. doi: 10.1001/jama.300.8.900-b. JAMA. 2008. PMID: 18728254 No abstract available. - Guest authorship, mortality reporting, and integrity in rofecoxib studies.
Ferris S, Galasko D, Kirby L. Ferris S, et al. JAMA. 2008 Aug 27;300(8):901-2; author reply 904-6. doi: 10.1001/jama.300.8.901-c. JAMA. 2008. PMID: 18728256 No abstract available. - Guest authorship, mortality reporting, and integrity in rofecoxib studies.
Hawkey CJ. Hawkey CJ. JAMA. 2008 Aug 27;300(8):901; author reply 904-5. doi: 10.1001/jama.300.8.901-b. JAMA. 2008. PMID: 18728257 No abstract available. - Guest authorship, mortality reporting, and integrity in rofecoxib studies.
Patrono C. Patrono C. JAMA. 2008 Aug 27;300(8):901; author reply 904-5. doi: 10.1001/jama.300.8.901-a. JAMA. 2008. PMID: 18728258 No abstract available. - Guest authorship, mortality reporting, and integrity in rofecoxib studies.
Costa SD. Costa SD. JAMA. 2008 Aug 27;300(8):902-3; author reply 904-5. doi: 10.1001/jama.300.8.902-b. JAMA. 2008. PMID: 18728259 No abstract available. - Guest authorship, mortality reporting, and integrity in rofecoxib studies.
Balon R. Balon R. JAMA. 2008 Aug 27;300(8):902; author reply 904-6. doi: 10.1001/jama.300.8.902-a. JAMA. 2008. PMID: 18728260 No abstract available.
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