Attribution of industry-financed literature
Authorship rules decide who may sign an article, but an industry-financed article tells its readers far more than its byline does: who planned it, who paid for it, who owns the data and who wrote the words, and whether those facts sit where a reader will meet them. That whole account is the article's attribution, and in industry literature it is bound up with advocacy marketing, with failures the authorship vocabulary does not name, and with proposals for how far disclosure could go.
Attribution as a whole
One critic of commercial publication practice, Alastair Matheson, argues that the ethical difficulties surrounding authorship in industry-financed journal articles cannot be understood from authorship alone, and that the attribution of those articles has to be examined as a whole. Attribution is sometimes thought to be synonymous with authorship, but on his definition it is the sum and balance of everything an article or presentation communicates to its audience about its provenance and development, and about its stakeholders and contributors, their roles and their interests. Its components are the authorship itself, including the number of authors and any corporate authorship; the author sequence; contributor listings; acknowledgements and footnotes; labelling and advisory statements; textual descriptions of stakeholder roles; disclosures, including interest disclosures; and the title, where a group or company is identified in it. Individual components such as authorship, contributorship and disclosure have been addressed by the editorial community over the decades, while attribution taken as a whole has received scant attention — the term appears nowhere in the ICMJE Recommendations current in 2016, which ran past 13,000 words. Matheson counts attribution a poorly developed concept in medical editorial thought, and holds that the medical editorial community must develop a more sophisticated conception of it.
On this definition attribution depends on what the reader notices, not merely on what is documented or disclosed, and proper attribution requires clear communication with the reader. An article carrying comprehensive, nominally transparent disclosures, but placing the key facts about its provenance and development in the small print while secondary details capture the reader's attention, is on this account poorly attributed. Proper attribution requires the key information to be related fully, in clear language, with the most salient of it made prominent at the head of the article rather than buried in small print; an article that fails to do that may be misattributed if it gives a misleading overall impression of how it was developed. In Matheson's experience this is an enduring problem in the pharmaceutical industry's journal literature.
Matheson tests an article's attribution by one overall question and four criteria.
- Does the attribution actively bring the truth about the article's provenance and development to the reader's attention?
- Salience: are the most important facts isolated and presented to the reader?
- Conspicuity: are the most important features brought prominently to the reader's attention at the outset?
- Clarity: are the facts presented in clear, unambiguous, non-euphemistic language?
- Inclusiveness: are any key facts omitted?
Advocacy marketing
Advocacy marketing is the presentation of marketing-related data or argument to potential customers through their peers and opinion leaders rather than through company representatives. It occurs in numerous retail sectors, where products are promoted by members of the public or by respected personas rather than by salespeople, which encourages consumers both to trust and to respect the product message, two key marketing objectives. In pharmaceutical marketing the customers are chiefly practising clinicians and the advocates are respected academics, many recruited for their status as key opinion leaders and others cultivated as rising stars in longstanding relationships that benefit company and academic alike. Matheson calls it the single greatest ethical problem in contemporary industry publications.
In publications it works in two steps: the company shapes the content to deliver its intended messages, and the attribution of that content is then assigned primarily to academic recruits. In rare cases content is simply written by a company and then signed unmodified by a key opinion leader. More generally, in his experience, content is developed with academic participation but subtly steered by the company to incorporate commercial perspectives, after which its attribution is subtly spun to exaggerate its academic credentials while the company that is its true master is credited with mere support or sponsorship. He names the two halves content spin and attribution spin, the first operating through planning, message formulation, research design, results analysis, author selection, manuscript development or review, and the second through authorship, author sequence, vague language, euphemism, omission, poor labelling and small print.
On Matheson's reading, Good Publication Practice (GPP3) itself illustrates many points at which content can be commercially guided: publication planning, which may propose themes, provisional titles, authors, journals and messages; author selection, either directly by the company or indirectly through committees it initiates; the inclusion of company co-authors on most industry trials; company analysis of the data; the use of editorial teams and writers; and company review. Collectively, he argues, these give extensive opportunity for content steerage, and GPP3's wording is subtle: it requires authors to control manuscript development and to make final decisions, but not that they have sole control or make all decisions — which authors do not, most of them being in any case the company's trusted academic recruits or its employees.
On the attributional side, the attribution of industry literature commonly emphasises academic leadership. Academics and their institutions are commonly placed conspicuously at the head of author bylines while industry employees sit inconspicuously in the middle or towards the rear and are often fewer in number; the company is rarely identified prominently, in the title or as a corporate co-author, and where it is identified, for instance at the foot of an abstract, it is credited misleadingly with mere funding or support. Contributor listings generally do not distinguish company from academic co-authors and are set in small print; interest disclosures typically bury the academics' relationships with the company among a mass of other small-print disclosures; writers are usually denied co-authorship and acknowledged only in small print; and textual descriptions of the company's role generally omit key facts such as company instigation or private data ownership — facts GPP3's own disclosure recommendations also omit. The collective effect is to position senior academic authors as leaders of publications planned, financed and substantially drafted by companies that analyse and secretly own the data, which supplies academic endorsement and, as another author has noted, may make publication in a prestigious journal likelier, since its editors and readers may prefer to see academics at the head of a byline.
Corporate ghost authorship and the disposable author
In Matheson's analysis, content steerage and attribution spin lead to two further concepts. Corporate authorship is the case in which a company, considered as an entity, plays an authorial role. Corporate ghost authorship occurs when a corporate entity plays an authorial role but is not given a commensurate, appropriately frank and prominent attribution in the published article; Matheson considers it a greater ethical problem in industry publications than ghostwriting, which remains controversial there.
The second is the disposable author: an academic author recruited into a commercial project who could readily be exchanged for another without significant impact on the project or the publication. His argument is that the chief ethical problem for academic recruits is not that they are guest authors — most, he says, are not — but that they are positioned as leaders when their involvement is a contingent detail. Had they or their institutions been unavailable, or had the company chosen differently, other institutions and academics could and would have been selected; the particular academic who signs is not decisively important, while what is vital, to the marketing as much as to the science, is that academics as such are recruited. Whatever the scale of their contribution, they are conditions of possibility for a company project that would have proceeded regardless, which on this argument makes it unethical for them to head the attribution of the literature.
Limits of the journal editors' recommendations
Matheson's claim is that the attribution of industry literature, authorship included, is routinely spun for marketing purposes to exaggerate the role of academics and downplay that of companies, and that this is unethical yet consistent with medicine's editorial recommendations as they stood in 2016. He credits the journal editors with many valuable steps to uphold scientific and ethical standards: better documentation of individual contributions through contributor listings and acknowledgements, enforcement of author accountability, securing author access to company data, promoting compliance with research guidelines, enforcing trial registration, and improving interest disclosures. His objection is that none of those measures challenges the exaggeration of academic roles and the understatement of commercial ones that advocacy marketing depends on.
He goes further and charges that the ICMJE Recommendations of 2016 assist the practice. They exclude writers from byline authorship of research articles; they set no requirements for corporate authorship; they permit omission and euphemism in descriptions of industry's role, recommending terms such as funding, support and sponsor; and they give no advice on what information should be brought more actively to readers' attention. The consequence he draws is that articles planned, financed and drafted by companies reporting their secretly held data continue routinely to be published under supposed academic leadership. On his view the guidelines, recommendations and position statements on authorship would not go far enough even if they were followed perfectly, and editorial guidelines should change so that companies, not their contingent academic recruits, are assigned the dominant authorial role in industry-financed journal literature.
From institutional corruption to commercial-academic assimilation
The practices above require the participation of drug companies, marketing companies, publishers, journals and recruited academic authors, and on Matheson's account the culture of industry publications could not endure were the interests of all of them not met. Academics gain prominent authorial credit and career benefit from the research and publishing opportunities that industry partnership brings; drug companies obtain publications and endorsements to promote their products; marketers secure lucrative publications contracts; journals receive copy; publishers receive substantial reprint revenues. All of them benefit, and all can claim that their conduct is fully ICMJE-compliant, meticulously transparent and ethical.
Lessig defines institutional corruption as a systemic and strategic influence, legal in itself, that undermines an institution's effectiveness by diverting it from its purpose or weakening its ability to achieve it, and on Matheson's account medical research and publishing, insofar as they can be considered institutions, are vulnerable to it through the systematic and strategic influence of pharmaceutical marketing. He sets it within a wider frame: the drug industry, biomedical science, medicine, marketing and the publishing industry form an interconnected mesh of institutions, practices, discourses, traditions and cultures in continual interaction and evolution, and institutional corruption occurs when commercial drives within that setting deflect the scientific, clinical and publishing domains from their traditional goals. Because commercial forces reach across many institutions and discourses, he prefers the term cultural corruption, while accepting that institutional corruption remains valid within individual institutions and discourses. Cultural corruption, as he defines it, is a state in which the norms of conduct and ethics within culturally linked institutions and discourses are distorted by cultural change, typically involving money or power.
The term corruption, he argues, does not capture the full range and subtlety of the change, and editorial opinions differ over whether industry's presence is harmful or beneficial. The most troubling trend is perhaps best characterised not so much as a deflection or deception of traditional academic discourse as a gradual merger of the domains of commerce and medical science into a hybrid research culture in which the distinction between what is scientific and what is commercial becomes by slow decrements less apparent and less important. He calls this commercial-academic assimilation and finds it operating at the level of institutions and the geography of research, of universities, research groups, personnel and academic appointments, of clinical research, and of publications — whose webs of small-print disclosure function, on his reading, more to integrate the contributions of commerce and academia than to differentiate them. The practices he describes are pernicious on his account not only for the advocacy marketing they serve but because they too subvert the boundary between what is commercial and what is not, and once commerce is so blended into academia that its presence is a routine detail giving little pause for thought, marketing's campaign for access into the soul of medicine is won. On his account biomedical science is threatened not merely by commercial corruption but by this creeping merger between the worlds of science and commerce. He holds that spun attribution is not merely misleading but part of a pernicious cultural transformation of science and medicine that everyone concerned for scientific integrity should resist.
Proposals for corporate attribution
Matheson holds that the problems of misattribution in commercial literature could be solved by taking corporate authorship seriously. For any article financed by a company and reporting on its product, in which the company, its employees or its hirelings participated at any stage, the first author should be the company itself — Merck, Inc., in his example — and the other authors could remain unchanged, although in his opinion writers should be co-authors; alternatively, the company should be named at the beginning or end of the title, in a form such as "A Merck, Inc. Trial".
For every industry-financed article, review articles and consensus statements included, the abstract and introduction should state the article's commercial provenance and marketing function: that the article has been planned and financed by the named company with assistance from a named medical communications agency, in connection with the marketing of a named product. Articles should also carry a dedicated Commercial Considerations section within the methodology, explaining the commercial rationale and how it influenced the review themes or study design; his example has a sponsor explaining why it chose 24-hour blood pressure control rather than absolute reduction as the measure, why it chose that particular comparator, and why it ran the study at thirty-five centres rather than a few, the last because, though statistically less robust, doing so familiarised more physicians with the product, which may lead to higher sales. And there should be joint measures by journals, societies and academic institutions to ban physician advocacy from medicine.
On his account academic lead authorship should never be allowed to dominate attribution, and editors must understand that transparency, disclosure and documentation — vital as they are — do not amount to good attribution if readers are not actively presented with the most salient facts about what they are reading. Measures of this kind, he holds, should have been enforced by journals decades ago, but that would have been incommodious to advocacy marketing, to academic authors, to the vanities and anxieties of professional medical culture, and to publishers filling journals with literature and coffers with reprint sales; the only beneficiaries of truthful attribution and a true description of commercial considerations, he argues, would be scientific integrity, the scientific record, journal readers and their patients, whose bodies are the ultimate target of the marketing enterprise. Such measures, in his view, would not only prevent misattribution and reduce advocacy but also bolster the distinction between commercial and non-commercial science and combat cultural blending. To support that goal and assist research on industry practices, the US National Library of Medicine should introduce an obligatory publication category, "Commercial", for all industry-financed literature.
The publications trade's challenge
In an appeal to the pharmaceutical and publications trades, Matheson holds that there is much to celebrate in mercantile science, as the industry's own traditions of scientific research and discovery show; collaboration between commerce and science can be beneficial, and increasing commercial-academic interaction, welcome or not, is the reality to be lived with; the challenge is to maintain scientific rigour, frankness, freedom from bias and intellectual independence in a world of growing commercial partnership. Much of today's commercially financed publications culture, on his account, shows how not to meet that challenge: its output is vulnerable to bias in framing and content, may incorporate subtle commercial positioning into scientific text and may report or discuss research designed to sell rather than to discover; its patient-level data are secret; and its attribution is commonly spun to impress readers. Many trade writers are former scientists who, he believes, understand the importance of absolute truthfulness and frankness in science and know that, whatever the ICMJE might allow, the trade's published output too often falls short of the standards science should attain. On his account the trade deserves to have the frankness to call itself a trade, to be open with readers about the commercial objectives of publications, to abhor euphemism, omission, understatement, vagueness and small print in reporting industry roles, and to respect and vigorously defend the distinction between commercial and non-commercial science. His view is that the publications trade needs new guidelines, a new trade association and new leadership to get there.