Ghostwritting> why you cannot trust studies unless you do them yourself.

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urge

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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, contractingwith
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.
JAMA. 2008;299(15):1800-1812 www.jama.com

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