What should be done to tackle ghostwriting in medical literature?
As mentioned in our guest blog on the Wyeth ghostwriting case, alongside The New York Times article are the released documents relating to a “case study” of ghostwriting outlined in the article. The documents explain how Wyeth used the medical communications company Design Write to outline and draft an article describing the hormone drugs as the “gold standard” for treating menopausal symptoms, but the article was officially authored by an academic. The successful intervention by PLoS Medicine and the New York Times leading to the availability of these documents is the subject of discussion on the NPR blog, the health blog the Wall Street Journal, and Nature‘s Great Beyond blog, and this Canadian Business Ethics blog.
To learn more about ghostwriting in medical literature, you might be interested in this February 2009 debate published in PLoS Medicine which discussed ghostwriting, strategies for handling it, and the importance of transparency for authors, editors and journals. All contributors to the debate agreed that a transparent declaration of author contributions is an essential element of a published article, but they provided different perspectives. Peter Gøtzsche argued that ghostwriting is “scientific misconduct” because it prevents proper accountability of the role of authors and study sponsors in the publication process – he cited a recent example of ghostwriting involving the anti-inflammatory drug rofecoxib (Vioxx) and the Journal of the American Medical Association (JAMA), and made ten suggestions for journals and editors to reduce misappropriated authorship.
Whilst agreeing that ghostwriting “debases the fundamental tenets of the medical profession”, Jerome Kassirer provided a different viewpoint, arguing that ghostwriting can be difficult to define and that there is a lack of uniformity among journals – the “gatekeepers” of scientific literature – regarding authorship criteria. He said that more evidence is needed of its existence and that excessive regulation should be avoided.
The third perspective on ghostwriting came from an international group of professional medical writers who argued that as long as their contribution to publication was explicitly disclosed, “the communication expertise and health care knowledge” of professional medical writers could help researchers publish and disseminate their research. They proposed a checklist for authors to help facilitate the disclosure of writing assistance.
The need to increase awareness of ghostwriting, and develop robust journal policies regarding the practice, is one of five proposals set out in this PLoS Medicine editorial to reduce bias in the scientific literature.
What does PLoS Medicine do to encourage transparent authorship?
As stated in our Guidelines for Authors, PLoS Medicine requires that the involvement of any professional medical writer is declared and we encourage authors to consult the European Medical Writers’ Association Guidelines on the role of medical writers. Before a decision to publish an article submitted to the journal is made, each author has to state the specific contributions they have made to the study or writing of the manuscript and each author has to declare that it is appropriate for them to be named as an author under ICMJE criteria. We also ask each author to make a declaration of competing interests – which can be financial, or non-financial (such as personal or professional relationships, or political or religious views when relevant)
We warn corresponding authors that a paper may be held up during the review process if these statements are not received from each individual author. All of these authorship statements and declarations of competing interests relating to a paper are published with the article. You can also find the annual declaration of competing interests of the PLoS Medicine Editors online.
Upcoming posts on the unsealed Wyeth documents are coming soon – and you can keep up to date with this and other topical medical issues by signing up for the Speaking of Medicine eNewsletter.
What about different kinds of “ghostwriting”, such as when researchers have actually been involved in a study and refuse to have an industry member very much involved with writing the paper listed as an author not to “discredit” their research? What if an industry member offers to write something for the sheer sake of pushing academic researchers to finally submit results which have a lower priority for them than for the industry?
The solution is easy. Ask my kids what to do. See http://www.MDWhistleblower.blogspot.com for some easy advice on what should be an easy issue. Is this really controversial at all? If you sign it, then it should mean that you wrote it.
[…] and posting them on their site. Other postings by Adriane Fugh Berman (see here and here) and by Andrew Hyde on this blog have discussed these documents. We hope by making them freely available that they […]
There has been a lot of positive movement on this topic in recent months since the Times article was published. The Institute on Medicine as a Profession has updated their vast online conflict of interest policy database to include the topic of ghostwriting. Many Academic Medical Centers have instituted strong policies against ghostwriting, just in the last few months.
View the database at http://www.imapny.org/conflicts_of_interest/search_policies