By Joe Orsini

OCTOBER, 2005 -- Medical “ghostwriting”—specifically when writers working for medical education agencies prepare manuscripts for clinical investigators and key opinion leaders—has in recent years come under considerable fire from both the medical and lay media.^1-6 Because drug companies are often the source of funding for these articles, critics charge the manuscript preparation process is susceptible to the influence of corporate marketing strategies, “inject[ing] bias and untruth into the scientific dialogue in order to enhance corporate profits.”²

It is true that drug companies support the development of manuscripts for submission to peer-reviewed medical journals. Publishing the results of comparative and placebo-controlled clinical trials of drug company products helps establish these products as legitimate treatment options. Industry-sponsored review articles focusing on the management of specific disease states helps keep doctors current on available and emerging therapeutic alternatives.

The extent to which marketing becomes involved in the manuscript preparation process is a contentious issue, one apparently not without validity.¹ There is a big difference between targeting a journal for the submission of a manuscript, and actively participating in the drafting of content. I have always believed that the content of an article—and how it is presented—is best left to the discretion of the author or coauthors. In my experience as a writer and editor, this rule has always applied.

The ghostwriting process in healthcare communications is not unlike that in other publishing fields. A paper typically undergoes several rounds of review between the named author(s) and the writer before it is submitted to a journal. The named author(s) have final editing authority. As far as I am aware, the submitted draft represents their views on and interpretations of the data presented—not necessarily those of the writer, medical education agency or supporting drug company. It is up to the writer to present and frame the information accurately, succinctly and with style.

What appears to be most at issue in the medical ghostwriting controversy is the extent to which drug companies—or persons paid by drug companies—influence the content of industry-funded articles. This raises the question: Do drug companies and the clinicians employed by them have a right to a voice in the medical literature? I would argue yes, so long as there is transparency in manuscript submission.

Some medical journals already require full disclosure of financial support and professional assistance in the preparation of manuscripts. Industry wide, however, submission requirements vary, and this has undoubtedly helped drive a perception of conspiracy involving the author(s), ghostwriter, medical education agency and drug company.

Perhaps the best way to address this controversy is for medical education companies and professional writers’ organizations (eg, American Medical Writers Association) to establish a constructive dialogue with editors and publishers of medical journals. In arriving at solutions to the problem, they might consider the following:

1. With respect to the development of manuscripts, data should be presented in an “objective, balanced and complete manner,” consistent with the ethos of the Pharmaceutical Research and Manufacturers of America.⁷
2. With respect to the submission of manuscripts to medical journals, a policy of full disclosure should be mandatory. Professional writers contributing substantively to the content of manuscripts should be listed as coauthors or acknowledged as appropriate. Industry funding should be specified.