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- ↵*Address correspondence to:
Anthony N. DeMaria, MD, MACC, Editor-in-Chief, Journal of the American College of Cardiology, 3655 Nobel Drive, Suite 400, San Diego, California 92122, USA.
The JACCEditors meet on a weekly basis to select papers for acceptance and to discuss general issues concerning the Journal.At this week's meeting, a spirited and animated discussion occurred with regard to our policy toward potential industry input into manuscripts. The influence of commercial entities upon papers published in JACCis, of course, a matter of importance for all types of articles. However, vendor input presents some specific issues for State-of-the-Art or review-type papers. Although there was not universal agreement among the Editors on every point discussed, a general consensus did evolve. I thought this would be of interest to our readers, and so it is the subject matter for this month's Editor's Page.
Conflict of interest, actual or potential, has become a major topic for medicine in general, and cardiology is no exception. It is clear that the medical industry now plays a significant role in virtually every aspect of cardiology. Support from commercial entities is present in medical education, in basic and particularly clinical research, in clinical care in the form of direct-to-consumer advertisement, and even in the organizational aspects of medicine by virtue of the support for professional societies. The prevalence of such interactions led the New England Journal of Medicineto conclude that it was virtually impossible to identify individuals with sufficient experience and recognition to author reviews who were free of affiliations with industry. It should be acknowledged that the involvement of drug and equipment vendors with the medical establishment is typically done openly, ethically, and often without direct benefit to the vested interest of the private party.
Given the ubiquity of industry relationships, and their generally benign nature, the profession has settled on full disclosure as the accepted means of dealing with the issue. Thus, it has been thought that a complete declaration of every relationship which could possibly bias writings or presentations would adequately deal with the potential conflict, in that the reader/audience could take the relationship into account and “judge for themselves.” This is certainly how JACChas approached the issue, and the relationships declared by authors can be seen in nearly every issue. In fact, interaction with industry can occur at virtually every phase of the process of publication. Authors with relationships submit papers that are evaluated by reviewers with relationships, which are on occasion overseen by Associate Editors with relationships, and are sometimes commented upon by editorialists with relationships.
Although, as stated above, the standard policy is to accept full disclosure as sufficient action to deal with potential conflict of interest, this does not mean that industry relationships do not influence the peer-review process. Reviewers are usually very attuned to potential bias, and they often point out instances of uncritical analysis or overstatement of the implications of research findings. Such assessments usually find their way into the priority scores, which are assigned for publication. In some cases, the appearance of potential conflict of interest is enough in and of itself to recommend that a manuscript not be accepted for publication. Nevertheless, neither has any policy been explicitly stated nor have criteria for such action been defined. The influence of existing industry relationships upon the peer-review process is just one of the examples of the subjectivity that can enter into the ultimate determination of which papers are accepted for publication.
At this point, I should digress to point out that affiliation with medical vendors can exert bias on reviewers as well as authors. The editors consider that one of our most important roles is to calibrate for any influence that such relations may have upon referees. Although the best approach to this problem is to avoid soliciting reviewers for whom potential conflicts of interest exist, these associations are often not known until after the critique is in. Given the realities of academic medicine today, even the editors are not completely devoid of associations with pharmaceutical or device companies. In such cases, we remove ourselves from the peer-review process completely, usually with the assistance of a Guest Editor. Finally, it should be acknowledged that relationships with industry are not the only source of conflict of interest. Professional advancement, notoriety, and success in competition are all strong stimuli for conflict of interest. In fact, my impression is that the editors more often suspect competitive pressure as influencing the editorial process, either by author or reviewer, than relations with industry.
Having provided a picture of how industrial affiliations are generally handled, one exception we have grappled with at JACCis State-of-the-Art or review articles. These papers analyze original research and synthesize the results into general conclusions and/or recommendations. They are typically authored by individuals whose expertise is evidenced by their own research contributions to the field and by recognition from their peers. Therefore, these are precisely the types of individuals who are sought out by industry as grantees, speakers, or as consultants or advisors to the company. Because analysis, interpretation, and synthesis, often of conflicting data, are important aspects of these papers, they are particularly susceptible to suspicions of bias, subconscious or otherwise. Nevertheless, as it is virtually impossible to find an expert who has not interacted in some way with a commercial entity, we have generally followed the usual policy of disclosure in the past. However, we have encountered several new issues that have led to a change in our approach to these papers.
We have recently received a number of review-type articles in which industry has had a role in producing the paper itself. In some cases a company provided financial support, either to offset the cost of preparing the study (e.g., literature search) or even as an honorarium. In other cases a commercial entity directly or indirectly provided illustrative material. In the cases with the greatest degree of vendor impact, company employees or a retained medical writer have helped to draft the manuscript. Such papers often appear as part of a supplement to a journal, which is sponsored by a specific company and directed primarily to a specific drug, device, or procedure. In such cases the potential involvement of industry is readily apparent. However, we are increasingly receiving review-type articles that are unsolicited and arrive as stand-alone submissions. Not surprisingly, these articles are often written by recognized authorities (with disclosure of industry input) and are extremely high quality. Nevertheless, they have been an increasing source of unease and concern to the editors. In fact, we have generally declined these submissions.
On the face of it, one would think that review-type articles should be treated just like original research. The authors nearly always fully disclose their industrial relations, the papers typically are factually accurate and well presented, and there is little evidence of bias. However, these articles differ from original research papers in that only peer-review journals can present original research, whereas numerous outlets exist for review material. Given the strong involvement of the medical industry with the profession today, it is not surprising that commercial entities may help provide educational material to physicians in “throw-away” journals, other medical periodicals, and medical meetings. What is different about a competitive peer-review journal like JACCis that we provide papers with analyses and syntheses that are as devoid as possible of input from entities with a vested interest in the subject. Although readers may wonder if they have adequately filtered any potential bias from articles with industry input, they do and should feel that papers in JACCare as free as possible from any external influence, regardless of how soft or indirect. I must admit that this opinion is held only to varying degrees by individual JACCeditors, but it does reflect the consensus of the group, and certainly represents my own opinion.
So, where do we at JACCstand at the moment? To begin with, the issue of potential conflict of interest is receiving increasing attention in all facets of medicine, particularly journals. I will address this again in more detail in a subsequent Editor's Page. The editors have no desire to become detectives, and they generally ascribe to the philosophy that full disclosure of industry relations provides sufficient protection for readers currently. We approach manuscripts (and reviewers) on a case-by-case basis and make decisions for acceptance based upon the usual multifaceted criteria. However, with regard to review-type papers, we have generally declined to publish those with financial or editorial support provided by a commercial entity with vested interest in the subject. We know we have rejected some very well-written and illustrated manuscripts in the process, and angered some authors as well. However, we believe it is the role of JACCto provide review-type articles reflecting the thinking of the authors themselves, as free as possible from any direct or indirect influence.
↵1 Editor-in-Chief, Journal of the American College of Cardiology
- American College of Cardiology Foundation