The ICMJE Recommendations and pharmaceutical marketing – strengths, weaknesses and the unsolved problem of attribution in publication ethics

Abstract

BackgroundThe 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.DiscussionWith 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.ConclusionsThe 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.

Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications

“…The World Medical Association states in its Declaration of Helsinki that all parties should adhere to accepted reporting guidelines, without mentioning those guidelines specifically 15 . Although the ICMJE guidelines are the most widely accepted authorship guidelines [3][4][5][6][7][8] , it has been suggested that they should be revised 1,16,17 ; one criticism is that they attempt to exclude medical writers from co-authorship and thus support the commercial development of ghostwritten manuscripts. The WAME Publication Ethics Committee states that "journals should publish guidance about what constitutes authorship", indirectly suggesting that the ICMJE criteria are not always adequate 8 .…”

“…However, the GPP3 and EMWA guidelines also state that medical writers generally do not meet authorship criteria unless "they contribute substantially to a review article" 3,4 . When considered against the claim that any contribution made by a medical writer has the possibility to influence content 16 and should be considered ghostwriting if they are not listed as an author 1 , it appears that some ambiguity remains.…”

Integrity in Scientific Research

“…8 The strategies to be implemented by biomedical journals to ensure these dimensions involve the requirement of ethics committees to approve the study before it is submitted, terms and conditions on conflicts of interest specifying the specific contribution of each author, independent statistical review, plagiarism detection software and full adoption of the recommendations of the International Committee of Medical Journals Editors (ICMJE). 9 Some of the most significant contributions of ICJME is the definition of who should be an author of a scientific paper, which is the individual who: (1) has helped conceiving or designing the work; or has obtained, analyzed or interpreted the research data; and (2) has participated in the drafting of the manuscript or critically revised it for important intellectual content; and (3) has given final approval to the version of the text to be published; and (4) agreed to ensure that the questions regarding the accuracy or integrity of any part of the work are properly investigated and resolved. 9 Besides the importance of defining scientific authorship, the ICJME calls the attention of the scientific community to the so-called "predatory journals," which use unethical practices to attract publications that are focused on business practices.…”

“…9 Some of the most significant contributions of ICJME is the definition of who should be an author of a scientific paper, which is the individual who: (1) has helped conceiving or designing the work; or has obtained, analyzed or interpreted the research data; and (2) has participated in the drafting of the manuscript or critically revised it for important intellectual content; and (3) has given final approval to the version of the text to be published; and (4) agreed to ensure that the questions regarding the accuracy or integrity of any part of the work are properly investigated and resolved. 9 Besides the importance of defining scientific authorship, the ICJME calls the attention of the scientific community to the so-called "predatory journals," which use unethical practices to attract publications that are focused on business practices. It is the authors' responsibility to evaluate the integrity of the journal to which submit their work.…”

“…9 The International Journal of Cardiovascular Sciences (IJCS) fully supports and takes initiatives to promote scientific integrity, such as detailed peer review; the requirement of specifying any potential of conflicts of interest after the conclusion of each paper; the need to seek approval from the Research Ethics Committee of the institution, according to CNS Resolution 466/12 when the work involves human beings in their entirety or in parts; and the author being required to fill out a form to specify the contribution of all co-authors pursuant to the ICJME's recommendations. 9 Initiatives that stimulate ethical behavior in research are encouraging, such as those proposed by the San Francisco Declaration on Research Assessment (DORA), which recommends not using any metrics, such as impact factors, in order to promote and hire individual researchers. 10 Taking these actions is of the essence to strengthen the practice of delivering quality research and it is crucial for t he society to make the most of the progress made by quality scientific research.…”