September 2008

Research papers often penned by drug companies

When trying to assess the credibility of a research paper, readers often rely on the reputation of the author or authors. However, an article in the April 16 issue of JAMA revealed that many research reports -- even those published in major medical journals -- are actually written by drug company employees and merely attributed to academically affiliated investigators who may have had little to do with the study, or who did not always disclose financial support from the sponsor of the 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," the JAMA report noted.

Joseph S. Ross, MD, MHS, of Mount Sinai School of Medicine, New York, and colleagues conducted a case-study review of court documents, in combination with a review of the relevant medical literature, to describe the practice of guest authorship and ghostwriting related to rofecoxib. The researchers used court documents, created predominantly between 1996 and 2004, originally obtained during litigation related to rofecoxib against Merck & Co. Inc. In addition, publicly available articles related to rofecoxib were identified via MEDLINE. Approximately 250 documents were relevant for the review.

When publishing their own clinical trials (designed, conducted, and sponsored by Merck), documents were found describing Merck scientists often working to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to "collaborate" on the manuscript as guest 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," the researchers wrote.

Documents indicated that medical publishing companies provided near complete drafts of review manuscripts to authors for editing, in addition to managing submissions and revisions.

Documents were also found describing Merck compensating investigators with honorarium for agreeing to serve as authors on review manuscripts ghostwritten on their behalf 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 concluded that individuals 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"

SOURCE: "Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation," Joseph S. Ross, et al, JAMA. April 16, 2008.