Research Article: Ghostwriting at Elite Academic Medical Centers in the United States

Date Published: February 2, 2010

Publisher: Public Library of Science

Author(s): Jeffrey R. Lacasse, Jonathan Leo

Abstract: Jeffrey Lacasse and Jonathan Leo assess ghostwriting policies at 50 academic medical centers in the United States and find that only 10 explicitly prohibit ghostwriting.

Partial Text: Medical ghostwriting, the practice of pharmaceutical companies secretly authoring journal articles published under the byline of academic researchers, is a troubling phenomenon because it is dangerous to public health [1]. For example, ghostwritten articles on rofecoxib [2] probably contributed to “…lasting injury and even deaths as a result of prescribers and patients being misinformed about risks” [3]. Study 329, a randomized controlled trial of paroxetine in adolescents, was ghostwritten [4]–[7] to claim that paroxetine is “generally well tolerated and effective for major depression in adolescents” [8], although data made available through legal proceedings show that “Study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm” [9]. Even beyond frank misrepresentation of data, commercially driven ghostwritten articles shape the medical literature in subtler but important ways, affecting how health conditions and treatments are perceived by clinicians. The ability of industry to exercise clandestine influence over the peer-reviewed medical literature is thus a serious threat to public health [1],[10].

Of the 50 academic medical centers that we examined (Box 1), ten (20%) explicitly prohibit ghostwriting. Of these ten, seven (14%) include some definition of ghostwriting in their policy, while three (6%) prohibit ghostwriting without defining the term. Many schools have an authorship policy that does not clearly ban all aspects of ghostwriting (n = 13, 26%); the most common reason is a failure to require that all qualified authors be listed. Three academic medical centers (6%) have stringent authorship policies that prohibit it in practice (by requiring both a substantive contribution to qualify for authorship and that all who qualify for authorship be listed) but do not mention ghostwriting by name (Table 1).

A minority of top-50 US-based academic medical centers (n = 13, 26%) publicly prohibit their faculty from participating in ghostwriting. It is ironic that ghostwriting, a major threat to public health, is generally not prohibited within institutions that exist to train physicians and improve the public health. In this way, academic medical centers enable the pharmaceutical industry to covertly shape the medical literature in favor of commercial interests. When a pharmaceutical salesperson hands a clinician an article reprint, the name of the institution on the front page of the reprint serves as a stamp of approval. The article is not viewed as an advertisement, but as scientific research; the reprint is an effective marketing tool because peer-reviewed journal articles generated in academia are perceived to be the result of unbiased scientific inquiry. Deception regarding authorship prevents a discriminating audience from properly assessing the impact of bias in the published article [10]. Importantly, this deception is impossible without the cooperation of faculty employed by academic medical centers.

Ghostwriting was once the “dirty little secret” of the medical literature [3], but this no longer is the case. Pharmaceutical companies have used ghostwriting to market sertraline [17], olanzapine [18], gabapentin [19], estrogen replacement therapy [20], rofecoxib [2], paroxetine [4],[21], methylphenidate [22], milnaciprin [23], venlafaxine [24], and dexfenfluramine [25]. Ghostwriting is now known to be a major industry [26].

Medical ghostwriting is a threat to public health which currently takes place only due to the cooperation of researchers employed at academic medical centers. Although there is growing awareness of the danger posed by medical ghostwriting, we find that few academic medical centers have public policies which prohibit this behavior, and many of the existing policies are ambiguous or ill-defined. We have proposed an unambiguous policy which defines participating in medical ghostwriting as academic misconduct akin to plagiarism or falsifying data. By adopting and enforcing this policy, academic medical centers would adhere to the norms of science followed across the rest of the University, and would no longer facilitate clandestine industry influence over the peer-reviewed scientific literature. By prohibiting medical ghostwriting, academic medical centers have a rare opportunity- to significantly reduce a major threat to public health with the stroke of a pen.