Here is a list of my published articles on publication ethics, attribution, science and commercial-academic culture. Most are available freely online through the links provided below.
The Abstracts are reproduced at the bottom of this page.
Articles
Matheson A. Can self-regulation deliver an ethical commercial literature? A
critical reading of the “Good Publication Practice” (GPP3) guidelines for
industry-financed medical journal articles. Account Res. 2019 Feb;26(2):85-107.
doi: 10.1080/08989621.2018.1564663. Epub 2019 Jan 24. PubMed PMID: 30607994.
For a toll-free link to this article, click here.
Matheson A. Marketing trials, marketing tricks – how to spot them and how to stop them. Trials 2017; 18: 105.
You can access this article here. I have also written a blog about the article for BioMed Central’s “On Medicine” column, which is available here.
Matheson A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. BMJ 2016; 354: i4578.
Here is a toll-free link to this article. Be sure also to look at the rapid responses for this article, in particular this one summarizing my debate with the commercial publications trade:
Matheson A. Trade associations’ joint statement on transparency in the commercial publications trade. BMJ 2016; 354: i4578; http://www.bmj.com/content/354/bmj.i4578/rr-10.
Matheson A. The disposable author: how pharmaceutical marketing is embraced within medicine’s scholarly literature. Hastings Center Report 46 (2015): 1-7. DOI: 10.1002/hast.576
http://onlinelibrary.wiley.com/doi/10.1002/hast.576/abstract
You can see a pdf here: Matheson HCR Early View layout 2016
Matheson A. The ICMJE Recommendations and pharmaceutical marketing strengths, weaknesses and the unsolved problem of attribution in publication ethics. BMC Medical Ethics 2016; 17:20. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4820950/pdf/12910_2016_Article_103.pdf
Matheson A. Attribution, advocacy, disposable authors, corporate ghosts and cultural assimilation: new themes in the ethical critique of commercial medical literature. Medical Writing 2016;25(1)25-30.
You can download this here.
Matheson A. How industry uses the ICMJE guidelines to manipulate authorship—and how they should be revised. PLoS Med 2011;8:e1001072. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001072
Matheson A. Corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical industry. BioSocieties 2008;3: 355–82.
You can download this here. Matheson Biosocieties 2008
Matheson A 2017. The bottom line: publications, or public relations? http://www.bmj.com/content/355/bmj.i5078/rr-3
This is a response to a BMJ article by the commercial “Medical Publications: Insights and Practices” (MPIP) initiative.
Matheson A 2018. Informed, uncorrupted clinical decision making should be the measure of marketing. (Letter.) BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3358
Abstracts
Matheson A. Can self-regulation deliver an ethical commercial literature? A
critical reading of the “Good Publication Practice” (GPP3) guidelines for
industry-financed medical journal articles. Account Res. 2019 Feb;26(2):85-107.
Much medical journal literature is developed by the pharmaceutical and device industries, sometimes with assistance from marketing agencies, writers, and academics. This literature is vulnerable to commercial bias. The publications trade issues self-regulatory ethical guidelines for its production, called “Good Publication Practice” (GPP). I evaluated the most recent iteration, GPP3. The most progressive recommendations in GPP3 call for complete publication of all clinical trials, and full data sharing. GPP3 makes numerous further recommendations more directly concerning the publications trade. Many of these repeat existing editorial requirements, chiefly those of the International Committee of Medical Journal Editors, but readers are not adequately advised of this. Despite its emphasis on ethical and transparent reporting, the detail of GPP3 enables continued use of academic medical literature for drug marketing, on the basis of commercial steerage of content, coupled with the attribution of published articles to collaborating academic authors. As such, GPP3 provides a de facto manual for how marketing through academic journal content can be conducted in compliance with contemporary editorial standards. Consequently, the self-regulatory GPP3 guidelines are not a sound basis for the production of unbiased industry-financed medical journal literature. I suggest improvements for future iterations of these influential guidelines.
Matheson A. Marketing trials, marketing tricks – how to spot them and how to stop them. Trials 2017; 18: 105.
BACKGROUND:
Last this year in this journal, Barbour and colleagues reported a study of “marketing trials” in leading medical journals (Trials 2016;17:31). In this commentary I discuss their research, describe new analyses of the study cohort and consider measures to address marketing within academic medical literature.
DISCUSSION:
Barbour et al. sought to identify a subgroup of “marketing trials” within leading medical journals, but in reality, nearly all industry-financed trials serve marketing functions, and many exhibit marketing-related features, including biases, in their framing, methodology or reporting. I conducted new analyses of the cohort of Barbour et al., showing that most trials funded exclusively by drug manufacturers had direct involvement of the manufacturer in design, analysis and reporting, and features supportive of product seeding. However, these commercial enterprises were without exception presented to journal readers as academic-led projects, using attributional spin, which should itself be considered an important form of marketing bias. Barbour et al. correctly conclude that commercial bias in industry clinical trials articles often requires expertise to recognize, and in many cases cannot be identified from the published journal report. Several potential remedies are discussed, including independent clinical research, data sharing, improved reporting guidance, improved tools for assessing research quality, reforms to article attribution, submission checklists and new editorial standards.
CONCLUSION:
Medicine’s journals have a responsibility to uphold rigorous scientific and reporting standards, require ready trials data access and ensure the commercial dimensions of research are brought prominently to their readers’ attention. Failure to meet these responsibilities constitutes an enduring threat to the integrity of biomedical literature.
Matheson A. Ghostwriting: the importance of definition and its place
in contemporary drug marketing. BMJ 2016;354:i4578 doi: 10.1136/bmj.i4578 http://www.bmj.com/content/354/bmj.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. I also
argue that the ghostwriting debate has deflected attention from
the broader set of strategies through which marketing influences
medical publications. The use of writers, regardless of whether
they are called ghosts, is just one of several options for building
commercial perspectives into academic literature, then spinning
their attribution to strengthen credibility.
Matheson A. The disposable author: how pharmaceutical marketing is embraced within medicine’s scholarly literature. Hastings Center Report 2016; DOI 10.1002/hast.576 http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1552-146X/earlyview. (pdf available on request)
The best studies on the relationship between pharmaceutical corporations and medicine have recognized that it is an ambiguous one. Yet most scholarship has pursued a simpler, more saleable narrative in which pharma is a scheming villain and medicine its maidenly victim. In this article, I argue that such crude moral framing blunts understanding of the murky realities of medicine’s relationship with pharma and, in consequence, holds back reform. My goal is to put matters right in respect to one critical area of scholarly interest, the medical journal publication.
Pharma relies on peer advocacy to sell its wares to prescribing doctors. This is an arrangement in which clinicians’ qualified colleagues, including “key opinion leaders,” are recruited by pharmaceutical corporations and marketing agencies to deliver commercially expedient content to their professional fellows. Precisely how this practice works in the setting of publications is not well understood because ethicists studying the problem have made too much of the narrative of corporate villainy and medical victimhood. Accordingly, criticism of industry publications has been preoccupied with the crudely dishonest practices of ghostwriting, ghost authorship, and “ghost management,” vices condemned as “dirty little secrets” perpetrated from “behind the scenes” with the connivance of academic “shills” or “guest authors,” in contempt of standards set by the International Committee of Medical Journal Editors. This account is appealing, and yet it is wrong or, at the very least, seriously incomplete, with only limited relevance to the actualities of contemporary industry practices. In truth, many commercial publications are not developed in secret but fashioned within a culture of open collaboration, where academic authors make substantial, independent contributions; pharmaceutical companies are showcased rather than hidden; and medicine’s editorial standards assist rather than impede the workings of commerce.
Matheson A. The ICMJE Recommendations and pharmaceutical marketing strengths, weaknesses and the unsolved problem of attribution in publication ethics. BMC Medical Ethics 2016; 17:20. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4820950/pdf/12910_2016_Article_103.pdf
Background. The International Committee of Medical Journal Editors (ICMJE) Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.
Discussion. With respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the ICMJE promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.
Conclusions. The ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry.
Matheson A. Attribution, advocacy, disposable authors, corporate ghosts and cultural assimilation: new themes in the ethical critique of commercial medical literature. Medical Writing 2016;25(1)25-30.
http://journal.emwa.org/authors-and-authorship/attribution-advocacy-disposable-authors-corporate-ghosts-and-cultural-assimilation-new-themes-in-the-ethical-critique-of-commercial-medical-literature
To clarify the ethical difficulties surrounding authorship in industry-financed medical journal articles, one must consider their overall attribution rather than authorship alone. Correctly understood, attribution involves not only authorship but everything an article communicates to readers about its stakeholders, origins, and development. Proper attribution requires that the most important aspects of the origins and development of an article are brought most prominently to the attention of readers, rather than disclosed in inconspicuous small print. An important ethical problem arises when, for marketing reasons, attribution including authorship is spun to exaggerate the role of academic recruits and downplay that of the companies themselves. This practice is unethical but consistent with medicine’s current editorial recommendations. Here, I introduce new themes and concepts in the ethical analysis of commercial practices, and propose changes to editorial guidelines to ensure that companies, not their contingent academic recruits, are assigned the dominant authorial role in industry-financed journal literature.
Matheson A. How industry uses the ICMJE guidelines to manipulate authorship—and how they should be revised. PLoS Med 2011;8:e1001072.http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001072
Scientists and clinicians need to know the authorship, author interests, and origination of the articles they read to judge them appropriately. Since 1985, the International Committee of Medical Journal Editors (ICMJE) has provided evolving guidance on how authorship should be managed in the complex setting of modern biomedical science, to the benefit of the published literature. Issues such as accountability, fraud, conflicts of interest, trial registration, and access to data have been considered by this voluntary, self-funded, closed-membership group of select general medical journal editors. However, certain industry practices, including publications planning, ghostwriting, and guest authorship, have yet to be adequately addressed. On the basis of industry publications and documents, textual analysis, and direct working experience in the “medical communications” sector, I show here how pharma has succeeded not merely in outmaneuvering the ICMJE guidelines, but is able to use them as the basis for inappropriate attributions of authorship.
Matheson AD. Corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical industry. BioSocieties 2008;3: 355–82.
This article analyses the role of the pharmaceutical and medical device industries (‘pharma’) in the construction of scientific and medical knowledge. Pharma’s activities are part of the broader dispositif of institutions, enterprises, regulations and constituencies within which medical-scientific knowledge is generated, but pharma’s contributions exhibit a specific character reflecting commercial pressures. As drug development proceeds, research and marketing activities coalesce around ‘product canons’ that integrate scientific truth-claims and commercial positioning, generating knowledge with implicit commercial functionality. From this platform, pharma stamps consensus-building ‘narratives’ into medical-scientific discourse, in which ‘problems’ arise and are ‘solved’ by drugs. Concurrently, pharma modulates the structure of discourse and the social networks through which discourse proceeds. Implicit within these activities is a meta-science whose goal is to understand and technologize the operation of science to an external end. This mode of knowledge production can be viewed as a normative transformation of Kuhnian normal science, characterized by the attachment (and at times subordination) of paradigmatic tenets to extrinsic goals; exaggerated control of belief, research and consensus formation; and a capacity for infringement of traditional norms of scientific truthfulness. An International Standard of Integrity in Science would strengthen pharma’s contributions to medical and scientific knowledge.
Alastair Matheson - Publication Ethics 