In Vioxx Studies, Merck Used Ghostwriters and Guest Authors
In recent documents that were examined and published on April 16, 2008 in an issue of JAMA, there were medical articles and court documents about rofecoxib. Rofcoxib, once marketed as Vioxx by Merck, is a nonsteroidal anti-inflammatory medication. It has become apparent that company employees or another unacknowledged author 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.
In biomedical publications, authorship provides recognition for scientists' labors, while coincidentally establishing a direction for responsibility and accountability. Ghostwriting is the failure to recognize the individual who has made contributions to the work. Guest authorship can be rewarded in cases where authorship criteria is not met in certain publications, but may have still contributed considerable to the research or writing of a manuscript.
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. and colleagues, all of Mount Sinai School of Medicine, performed a case-study review of relevant medical literature, court documents and publicly available articles from MEDLINE to describe guest authorship and ghostwriting as related to rofecoxib. For this review, approximately 250 documents were used.
The clinical trials that were designed, conducted and sponsored solely by Merck, documentation was found describing affiliated scientists were often working to prepare manuscripts while consequently recruiting external, academically affiliated investigators to collaborate as guest authors. The authorship risk was assumed by these authors according to the authors in this study. "Recruited authors were frequently placed in 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." At that time medical publishing companies would provide almost complete drafts to be reviewed by the authors for editing in addition to managing all submissions and revisions.
There is documentation 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. According to the study, of 96 relevant published articles, 92 percent (22 of 24) of clinical trial articles published a disclosure of Merck's financial support. Only 50 percent (36 of 72) of published review articles, either disclosed of Merck's sponsorship or disclosed whether the author had received any financial compensation from the company.
Indicated by the authors, there was a method to Merck's approach in publishing documents about rofecoxib. The case-study review of industry documents related to rofecoxib demonstrates that Merck strategically facilitated the publication of guest authors and ghost written medical literature. The doctors and scientists that conducted the study are hopeful that these findings encourage discussion of ways in which to improve the integrity of research. The medical profession and pharmaceutical industry should agree that collaborations must be conducted with the highest ethical standards. Academic researchers should consistently provide to the journals the author contributions for all manuscripts including the research, meta-analyses, reviews and commentaries. They should also disclose any relationship or support from all industry sources, regardless of the journal's requirements.
Authors of this study concluded that various methods by which this situation may be avoided in the future include: "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 XYX, 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."
Quotes taken from www.medicalnewstoday.com
Guest Authorship and Ghostwriting 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
