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14th March 2011
An article describes how ghost-written reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of hormone replacement therapy.
Action
Healthcare professionals should be aware of the potential for bias in articles, and be cautious in accepting claims made in individual publications promoted by the pharmaceutical industry. Prescribing decisions should be based on evidence-based information from organisations with a public sector ethos such as NICE, CKS, SIGN, Cochrane, CRD, Clinical Evidence, DTB and the NPC. These decisions should be based on consideration of the entire body of evidence and not just the claims made in individual publications.
Sponsors, medical writers, and named authors of publications all have responsibility to ensure that claims made in publications are fully supported by data, and that unjustified claims are not made. Editors of medical publications should insist that the contributions of all the medical writers involved the production of a manuscript are fully acknowledged in the published article.
What is the background to this?
According to this article, in recent litigation against Wyeth, more than 14,000 plaintiffs brought claims related to the development of breast cancer while taking HRT (conjugated equine estrogens and medroxyprogesterone acetate). In this article, information from some 1,500 documents revealed in the litigation was used to show how industry uses ghost writers to insert marketing messages into articles published in medical journals. Ghost writing occurs when someone makes substantial contributions to a manuscript without this being attributed or disclosed. This often requires the corollary of guest authorship (sometimes called honorary or gift authorship): this occurs when the author(s) in whose name(s) the article appears made small or even non-existent contributions to the manuscript.
What does this study claim?
The article describes how dozens of ghost-written reviews and commentaries, published in medical journals and supplements were used to promote unproven benefits and downplay harms of HRT, and to cast competitors in a negative light. Specifically, it claims that Wyeth used ghost-written articles to mitigate the perceived risks of breast cancer associated with HRT, and to promote off-label, unproven uses. The author suggests that the medical profession “must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.”
How does this relate to other studies?
This article provides an example of a practice, where a pharmaceutical company by managing its publications, often in collaboration with a medical communication company, may attempt to bias published results of studies in its favour. It is not possible to say exactly how common these practices are, due to their secretive nature, and such practices may only become transparent when internal company documents become available during litigation. However they appear to be common, even in the best of journals. The scenario presented in this article is by no means unique; guest authorship and ghost writing of publications for rofecoxib provides another high-profile example.
So what?
Ghost writing is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. As in the case of the example described in the present article, at the extreme, it involves pharmaceutical companies hiring professional writing companies to create publications containing marketing messages, subsequently published under the names of ‘opinion leaders’ who had only trivial roles in their preparation, and without disclosing the contribution of the writers and their roles. Ghost writing itself is not a scientific problem, but it becomes one when it is done in a secretive way to shape medical literature for commercial interests, to the detriment of public interest.
Recommendations to tackle the issue of ghost writing are presented in a recent Plos Medicine Debate article. They suggest that authors must take full control of the article published in their names, and take responsibility for claims made. They go on to say how editors of medical journals should ensure that full acknowledgement of those authoring the papers is given, and even insist that medical writers be authors, with disclosure of any conflicts of interest. Consistent with European Medical Writers Association (EMWA) guidelines, medical writers have professional responsibility to ensure that the articles they write are scientifically valid and are written in accordance with generally accepted ethical principles. According to the World Association of Medical Editors:
“responsibility for ghost written articles goes beyond individual authors. Other parties including companies — such as marketing, communications, and medical education companies who are paid to assist pharmaceutical and medical device companies in disseminating favourable messages about their products — may initiate and sequence events for which the author is the final and most easily identified participant. These other participants are also responsible for ghost-written manuscripts and addressing their roles should be part of the solution.”
In the meantime, health professionals need to be aware of the use of ghost writers as part of a wider publication planning strategy used to promote their products. The figure (taken from an article which considers the ethical considerations of publication planning in the pharmaceutical industry), may provide an insight into the possible roles of medical writers, sponsors, and authors in the process.
As stated in an article on ghost management:
“pharmaceutical company funding strongly biases published results in favour of company’s products [references given]. Ghost management amplifies that bias, because when one set of commercial interests exerts influence at multiple stages of the research, writing and publication, it will shape the resulting article. In turn bias affects medical opinion and practice, and ultimately patients.”
Healthcare professionals should be aware of the potential for bias in articles , and be cautious in accepting claims made in individual publications promoted by the pharmaceutical industry. Prescribing decisions should be based on evidence-based information from organisations with a public sector ethos such as NICE, CKS, SIGN, Cochrane, CRD, Clinical Evidence, DTB and the NPC. These decisions should be based on consideration of the entire body of evidence and not just the claims made in individual publications.
Sponsorship of article reviewed
There was no specific funding for the article. The author was a paid expert witness n behalf of plaintiffs in the litigation referred to in the paper.
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