Ghostwriting: the importance of definition and its place in contemporary drug marketing

Alastair Matheson’s recent article presents a multitude of claims regarding the role of professional medical writers in publications arising from pharmaceutical industry-sponsored research. Many of these claims are not supported by evidence and have been addressed previously by GAPP (1, 2). At the core of Matheson’s article are claims that there is no distinction between ghostwriters and professional medical writers, and that the pharmaceutical industry uses medical writers to insert commercial messages into the peer-reviewed literature. We completely agree with and support the International Society for Medical Publication Professionals (ISMPP) response (12 September 2016) to Matheson’s claims that there has been no “rebranding of ghostwriting” by industry and that rather, “there has been a positive evolution of transparency and completeness in medical publications reporting industry research.” As GAPP has stated consistently, professional medical writers are NOT ghostwriters because they ARE transparent about their involvement, are strictly prohibited from ghostwriting, and work within ethical publication guidelines that require authors to contribute to and control the content at every step of the publication process (3-7).

Industry does not promote rebranding of the definition of ghostwriting to downplay the role of professional medical writers

As Matheson describes, the definition of ghostwriting was not developed by industry, but is based on the International Committee of Medical Journal Editors (ICMJE) authorship criteria that were developed by journal editors to better define the contributions of medical writers in medical publications. In contrast to Matheson, these criteria do not ban medical writers from authorship. Rather, the ICMJE recommend that the contributions of medical writers should be disclosed in the acknowledgements or, if all four ICMJE authorship criteria are met, in the author byline (8). To promote transparency, individual member professional organizations such as the International Society for Medical Publication Professionals and the American and European Medical Writers Associations uphold these criteria and further recommend disclosing any potential conflicts of interest (eg, funding) (3-5). As recommended by Matheson in Table 2, disclosure of the medical writing funding source helps ensure that companies’ commercial interests and the role of medical writers are fully highlighted - not downplayed.

Matheson attempts to diminish the efforts by industry to disclose their involvement by describing the acknowledgement section as “small print” and “inconspicuous footnotes”. However it is important to highlight that the acknowledgement section of a peer-reviewed manuscript is not a footnote, and how it is presented is not controlled by industry or medical writers, but is controlled by the journal and its publisher. Placement of acknowledgments is highly variable and can range from prominent display on the first page to complete absence; however, the more traditional placement is between the end of the text and beginning of the references. More recently, some publishers are now sharing acknowledgement and/or funding information online with the article abstract.

Medical writers are used to influence the scholarly literature for marketing purposes

We agree with Matheson that many professional medical writers are highly qualified, honest, and have high scientific literacy. However we reject his claim that seemingly all professional medical writers serve commercial interests and permit industry leverage over content. Professional medical writers from industry and communication agencies work within ethical guidelines and routinely receive mandatory training on ethical publication practices (3-6). Findings from the Global Publication Survey, which was conducted from November 2012 to February 2013, showed that although agency respondents were aware of requests from authors or sponsors that they believed to be unethical, most (93%) indicated that the requests were withdrawn after the need for compliance with guidelines was explained (6). These data do not support the perception that leverage over content by medical writers is widespread. However, they do show that there is still work to be done on eradicating unethical publication practices.

Professional medical writers have a valid and valued role in assisting authors to prepare high-quality manuscripts that meet ethical, publishing, and regulatory requirements (9-18). We agree with Matheson that the transition to electronic publishing is likely to change the way contributions, including those by medical writers, to industry-sponsored research and publications are reported. However, until alternative guidance is universally accepted, the ICMJE criteria remain the most widely accepted authorship criteria available.

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