NeuroTalk Support Groups - Ethical considerations of publication planning in the pharmaceutical industry

http://www.openmedicine.ca/article/view/118/215
(excerpts from Open Medicine article)

Ethical considerations of publication planning in the pharmaceutical industry
December 23, 2008. Vol. 2(4), pp.33-36
Adriane Fugh-Berman, Susanna J Dodgson

"...The controlled production and release of pre-clinical studies, clinical trials, reviews and commentaries may begin years before a drug is launched (Fig. 1). Peer-reviewed clinical efficacy studies supporting a new drug or a new indication for a commercially available drug are considered “primary” or “core” publications. According to an industry article, “For a pharma company, getting research published in a peer-reviewed medical journal is like winning a stamp of approval from its most influential audience. It’s an automatic validation unmatched by any other medium.”2 Primary articles “[p]rovide authoritative sources for marketing communications and other promotional materials,” “[s]upport the positioning and selling platform, and coordinate with the overall marketing plan” and “[a]ccelerate the adoption of a new chemical entity or new indication.”1 In other words, they provide the foundation for subsequent “secondary” or “derivative” publications, which include journal advertisements, promotional materials used by sales representatives, and reviews and opinion pieces published in medical journals...

... extent of medical writers’ contributions to the medical literature is unknown. A limited study of 1000 research articles in 10 international journals found that a medical writer was acknowledged in about 6% of the articles. In a recent case study, researchers examined internal documents belonging to Merck that were revealed during litigation related to rofecoxib, and linked these documents to clinical trials and review articles published in medical journals. Of 20 rofecoxib clinical trial manuscripts that were, according to internal documents, authored by Merck scientists or medical writers, 16 gave an external, academically affiliated investigator first authorship position when they were subsequently published in journals. Furthermore, 50 of 72 review articles discussed within Merck prior to publication were published as solo-authored articles by academic physicians, and only 2 of the coauthored articles attributed authorship to a Merck employee.6

Publication planning, as it is currently practised by pharmaceutical companies, can undermine the medical literature. Industry control over the timing, content and authorship of studies and opinion pieces including reviews and commentaries distorts medical discourse. That academic health professionals (physicians, nurses, pharmacists) lend their names to articles to which they may have contributed nothing is ironic, considering that such behaviour by students in the same academic institutions would be considered plagiarism...

...Most peer-reviewed journals already require the disclosure of industry sponsorship for the publication of clinical trials and reviews. However, as we have discussed, it is difficult to discern when medical writers have been involved...

...The infiltration of the medical literature by undisclosed sponsors using ghostwritten articles raises serious ethical issues. The medical literature should be a repository of reliable, unbiased scientific studies and considered opinion. Invisible industry influences on publications and presentations undermine a vital foundation for clinical decision-making.