In their April 16, 2008 issue, the Journal of the American Medical Association (JAMA) published an article titled Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents from Rofecoxib Litigation based on documents discovered during lawsuits against Merck related to their brand-name drug Vioxx (rofecoxib).
Two of the major issues raised in this article are guest authoring and ghostwriting. These issues often go hand in hand.
Guest authoring occurs when an individual who does not meet authorship criteria is listed as a named author for an article. Many journals, including JAMA, follow the guidelines for authorship identified by the International Council of Medical Journal Editors (ICMJE). These authorship guidelines require that a named author be involved in the design of the study, conduct of the study or analysis of the data, and writing or substantively reviewing/revising the manuscript. Only those individuals meeting all three criteria should be listed as authors; anyone else who contributed to the manuscript should be listed appropriately in the acknowledgments section.
Ghostwriting occurs when an unacknowledged individual writes most or all of a manuscript, which is then submitted with other individuals as the named authors. The American Medical Writers Association (AMWA) has published a Position Statement on the Contribution of Medical Writers to Scientific Publications that recommends including a statement in the acknowledgments section to indicate when a medical writer or medical editor has provided assistance in writing or preparing a manuscript for submission to a journal as well as acknowledging the source of funding for these services. By including this information in the acknowledgments section, transparency is maintained. When this information is not included, then in effect the medical writer is acting as an unnamed ghostwriter for the named authors on behalf of the pharmaceutical company.
The recent JAMA article indicates that some of the rofecoxib manuscripts submitted for publication were written by Merck staff or by medical publishing companies on behalf of Merck. After the manuscript were drafted and a target journal chosen, then selected academic researchers or key opinion leaders were contacted about being named authors on these articles; this constitutes guest authoring. The recent JAMA also indicated that some manuscripts were written by staff at an external communications company at the request of the pharmaceutical company using paid medical writers; this constitutes ghostwriting.
From an ethical standpoint, it is more beneficial to the reader to know who was involved in designing and conducting a clinical study as well as who paid for it. When it comes to publishing the results, it is also important for the reader to know who analyzed the results and wrote the manuscript that result in the published article that they are reading. If a well-respected leader in a therapeutic area conducted an independent study, analyzed the results, and presented his conclusions in an article that was published in a scientific journal then readers would have a great deal of confidence in the information presented. On the other hand, if a pharmaceutical company designed and conducted a clinical study assessing the efficacy of one of their own products, had their staff statisticians analyze the data, and their internal medical writers or an external communications company write a manuscript, then readers might have less confidence in the presented material.
It is possible, however, that neither scenario is ideal. The thought leader could be so convinced that his hypothesis is true that he analyzes the data in such a way that skews the results. Or the staff at the pharmaceutical company could be striving to be as transparent, conscientious, and protective of patient health and well-being as is possible, rather than focusing only on their profits. The reality is likely somewhere in between. Transparency in terms of who did the work, who paid for it, and who is telling the scientific community about the results makes it more likely for individuals to have some trust in the presented data.
Named authors should have participated in the designing or conducting the study, analyzing the results, and writing or substantially revising the manuscript. Medical writers involved in preparing manuscripts should be acknowledged in the published article. Statisticians who analyzed the study data should also be acknowledged. The source of funding for the author, investigators, medical writers, and statisticians should also be included in the acknowledgments section.