1 Boring Old Man

Contributors and sources: The author worked from 1994 to 2012 as an independent consultant in the pharmaceutical, marketing and medical communications sectors, with extensive experience of market analysis, strategic communications planning, publications planning and medical writing. He has also studied the interface between academia and commerce from the standpoints of anthropology and publications policy.

Competing interests: I have read and understood BMJ policy on declaration of interests and declare the following interests: Between 1994 and 2012 most of my income came from consultancy and writing services provided to pharmaceutical corporations, either directly or via marketing agencies. In 2015 I acted as a paid expert witness on behalf of the plaintiffs in a US federal legal action against a drug company. I have valued friendships and acquaintances in the corporate pharmaceutical and marketing sectors. I consider myself to be a supporter of innovative pharmaceutical research, but a critic of some forms of marketing. I was solely responsible for all aspects of conception, design, and writing of this article and am the guarantor.

• How Commerce Reshapes Knowledge: Matheson on Pharma’s Influence on Science
  How Pharma Shapes Knowledge: Alastair Matheson Responds
• How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be Revised

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

by Alastair Matheson

British Medical Journal 2016 354:i4578.

During the past decade, the pharmaceutical publications trade has campaigned to persuade medicine, journals, ethicists, and the media that it is opposed to ghostwriting. Yet industry practices have changed little, and commercial drafting of clinical trial reports, consensus statements, and reviews that are authored by recruited academics remains routine. Here, I show that industry’s opposition is based on a redefinition of the term ghostwriting that obscures the continued, widespread use of the practice as originally defined in medical journal literature…

Outside medicine, a ghostwriter is “a person whose job it is to write material for someone else who is the named author.” Drug companies and their agencies use writers to develop articles for academic authors, and in the 1990s and early 2000s this was commonly understood as ghostwriting, both by journal editors and the pharmaceutical publications trade. But today, the trade promotes an alternative definition, whereby writers are not classified as ghosts if they are named in a footnote…

The Global Alliance of Publication Professionals, a trade advocacy unit, states: “A ghostwriter is someone who writes a paper, but whose name does not appear on the paper.” Simply by acknowledging writers for editorial or writing “assistance”—a practice always widespread—commercially written literature is by these definitions freed from the egregious ghostwriting label. Consider, for instance, two commercially drafted studies of paroxetine, both criticised for using ghostwriting to produce allegedly biased content. One, study 352, mentions no writer but the other, the notorious study 329, discloses at the end of a tract of small print that “Editorial assistance was provided by Sally K Laden, MS.” By the traditional definition, both articles are ghostwritten, but according to the trade definitions quoted above, Study 329 is not, even though the medical writer’s credit is inconspicuous…

What Matheson calls rebranding goes much further. For example, in Paxil Study 329 and Celexa CIT-MD-18, they redefined the meaning of a priori to before the blind is broken rather than before the study begins. Redefining Outcome variables is another common form of rebranding. But that’s just one of the tools of the trade in the process of misreporting the results of these clinical trial reports [I wonder if there’s a handbook somewhere that catalogs all the various tools and techniques available to misreport clinical trial reports?].

Matheson in an insider who knows the tools of the trade, and as such, he deserves to be listened to carefully – particularly when he suggests what should be done about all of this. He proposes a number of thoughtful standards for accurate attribution of Authorship, focusing his attention on the International Committee of Medical Journal Editors [ICMJE]. But I’m not sure that would change things any more than the many other attempts at reform – COI declarations, acknowledging funding sources, naming the ghostwriters, the Sunshine Act, etc. They’re all proxies. They don’t get at the central issue directly, which is accurate information about the trial results.