In Vioxx Studies, Merck Used Ghostwriters And Guest Authors

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Arthritis / Rheumatology;  Pharma Industry / Biotech Industry;  Clinical Trials / Drug Trials
Article Date: 16 Apr 2008 - 17:00 PDT

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In medical articles and court documents about rofecoxib, it has become apparent that company employees or another unacknowledged authors were often involved in writing the clinical trial and review articles, while primary authorship was awarded to academically affiliated investigators who may have been only peripherally related to the study. These documents were examined and published in the April 16, 2008 issue of JAMA. Rofecoxib is a nonsteroidal anti-inflammatory drug once marketed as Vioxx by Merck.

In biomedical publication, authorship provides recognition for scientists' labors, while coincidentally establishing a direction for accountability and responsibility. A failure to recognize an individual who has made contributions to the work as an author has been designated ghostwriting. For those who do not meet authorship criteria of certain publications, but have still contributed considerably to the research or writing of a manuscript, guest authorship can be awarded.

According to the authors of this study, "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." Joseph S. Ross, M.D., M.H.S., of Mount Sinai School of Medicine, New York, and colleagues performed a case-study review of court documents in combination with the relevant medical litreature and publicly available articles from MEDLINE to describe guest authorship and ghostwriting as related to rofecoxib. Apprxomiatedly 250 documents were used for this review.

When clinical trials were designed, conducted, and sponsored only by Merck, documents were found describing affiliated scientists often working to prepare manuscripts while subsequently recruiting external, academically affiliated investigators to collaborate as guest authors. According to the authors of this study, these authors were often placed in very important positions on the authorship risk. "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." Medical publishing companies provided almost complete drafts of review manuscripts to authors for editing in addition to managing all submissiong and revisions.

Additionally, documents were found describing Merck as compensating investigators with honorarium for agreeing to serve as authors on papers that had been ghostwritten for them by medical publishing companies. "Among 96 relevant published articles, we found that 92 percent (22 of 24) of clinical trial articles published a disclosure of Merck's financial support, but only 50 percent (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."

The authors indicate that there was a method to Merck's approach in publishing documents about rofecoxib.  "This case-study review of industry documents related to rofecoxib demonstrates that Merck used a systematic strategy to facilitate the publication of guest authored and ghost written medical literature," they write. "We are hopeful that our findings encourage discussion of ways in which to improve the integrity of research. The medical profession and the pharmaceutical industry should agree that collaborations must be conducted with the highest standards. We suggest that academic researchers consistently provide to the journals the author contributions for all manuscripts, including original research, meta-analyses, reviews, and commentaries, and disclose relationships and support from all industry sources, regardless of the journal's requirements..

The authors conclude with a call for various methods by which this situation might be avoided in the future."Authors who 'sign-off' on or 'edit' original manuscripts or reviews written explicitly by pharmaceutical industry employees or by medical publishing companies should offer full authorship disclosure, such as, 'drafting of the manuscript was done by representatives from XYZ, Inc.; the authors were responsible for critical revisions of the manuscript for important intellectual content.' A coordinated oversight strategy involving academic physicians, journal editors, and industry representatives is necessary to discourage both guest authorship and ghostwriting and improve the integrity of the biomedical authorship system."

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.
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Written by Anna Sophia McKenney


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