‘Ghostwriting’ is a contentious issue among both medical practitioners and medical writers. Previously, this issue typically only surfaced when either a politician decided to get on a bandwagon or a pharmaceutical company was implicated. In more recent times, lawyers are putting their case forward for policing the issue. In this upheaval, all players are involved, as described in two older articles in the New York Times on the issue of using ghostwriters in the medical literature and one more recently in PLoS Medicine, a medical journal from the Public Library of Science.
The first article described the use of ghostwriters by Wyeth as part of their publication plan regarding Premarin and Prempro, two drugs to treat the symptoms of menopause, known as hormone replacement therapy, or HRT.
The article reveals that ghostwriters ‘played a major role in producing’ 26 scientific papers (published between 1998 and 2005 in 18 medical journals) backing the use of HRT. The article cites several areas of concern: the lack of disclosure of a ghostwriter, the selection and involvement of the named author, and the continued recommendation for HRT after evidence of significant health risks associated with its use emerged.
According to the article, the ghostwritten papers were typically review articles and did not disclose Wyeth’s role in initiating and paying for the work. One example described in the NYT piece included acknowledgements of several medical writers for ‘editorial assistance’, but neither the use of a medical communications company, nor Wyeth, were mentioned. Also at issue is the selection of the named authorafter a detailed outline for the article had been drafted. A spokesman for Wyeth noted that the articles were peer-reviewed by the journals. Adding to the concern was the stopping of a large federal study in 2002 after an increased risk of invasive breast cancer, heart disease and stroke (and in a later study, dementia) with the use of certain types of HRT was discovered. The article’s information is based on court documents from a lawsuit against Wyeth.
More interesting though is the original whistle-blowers (see paragraph six) and the third article we will be discussing.
The second NYT piece is based on a letter written by Senator Charles Grassley – a Republican from Iowa who helps oversee public funding, including for medical research, and has been a vocal opponent of the relationship between the pharmaceutical industry and the medical profession – to the Acting Director of the National Institutes of Health (NIH) asking about NIH policies on ghostwriting and recipients of NIH grant money. Of particular issue is the participation by faculty members at American medical schools as ‘guest authors’ on such ghostwritten articles. As the article notes, ‘Many of the nation’s top doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines on the universities.’
The third and more recent piece published in PLoS Medicine has already had some exposure and attention, more so about the retribution of this issue as deterrent. In this article, the authors (one lawyer and two law consultants) argue that self-regulation has not produced results and the government has failed to have any significant impact on ghostwriting, and that the only remaining option is the legal system. The article then proceeds to illustrate the possible legal remedies that can help outlaw a practice that has “long tainted journal content and jeopardised patient safety”.
Our former editor, David Woods, PhD, offers a broad perspective on this topic, as a former journal editor himself and from other journal editors and leaders in medical publication.
He discusses an important point – the lack of clarity on what is an author, a ghost author, and a guest author. While we resolve those questions, full disclosure appears to be the best option for all involved: writer, investigator, editor, and reader.