Excerpts from: Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents

Introduction The influence of commercial interests on medical science is an area of ongoing concern. Recent work has examined the extent of this influence1-5 and explored best practices for managing conflicts of interest.6-9 A particular area of concern is the influence of conflicts of interest on the biomedical literature. Disclosure of authors’ financial interests in journal articles has been proposed as one strategy for protecting the integrity of research and maintaining public trust.10-12 The International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors, among others, encourage disclosure of authors’ financial interests.10,13-15 Despite repeated calls for financial disclosures and the growing number of journals with conflict-of-interest policies,12,16-18 the effectiveness of current approaches to disclosure remains unclear.16,19-23 How one defines effectiveness may depend on the parties involved, be they authors, editors, reviewers, or readers. For readers of the medical literature, it might be reasonable to expect that authors’ financial interests are disclosed in similar ways in articles on the same topic published around the same time. A system of disclosure that was not consistent in this way might create confusion or mistrust among readers and the public. In this study, we examined all articles on coronary stents published in 2006 to determine whether authors’ financial interests were reported consistently. Results We retrieved 746 articles, of which 623 were research articles (eg, clinical trials, case reports, meta-analyses) and 123 were commentaries, letters, and other communications that did not present original research. There were 2,985 authors and 135 journals. The number of articles per author ranged from 1 to 25. Of the 441 research articles (excluding case reports), 316 (71.7%) did not include a statement identifying the source of support for the study (including declarations of no support). These statements were more likely to appear in journals that endorsed the ICMJE guidelines (34% vs 21%; χ2 = 9.3; p = 0.002) and in journals with higher impact factors (median impact factor, 3.55 vs 3.06; p = 0.04). A total of 125 organizations were listed as sources of support. The top 5 sources (ie, Johnson & Johnson, Boston Scientific, CardioVascular Research Foundation [South Korea]; Ministry of Health and Welfare [South Korea]; and Guidant) accounted for 28% of the articles in which a source of support was declared. Eight of the 623 research articles (1.3%) contained statements describing the contributions made by each author. The maximum number of financial interests disclosed for a single author in a single article was 4. The disclosed relationships referred to 78 organizations. The 5 most frequent organizations (ie, Johnson & Johnson, Boston Scientific, Medtronic, Sanofi-Aventis, and Bristol-Myers Squibb) accounted for 59% of the relationships. In 4 cases, instead of a specific organization, the disclosure statement described relationships with multiple unnamed organizations (eg, “all drug-eluting stent companies,” “medical device companies”). Of the 468 relationships disclosed, the most frequent relationship types included receipt of research support (25%), speaker fees (17%), and consultancies (15%). Discussion In this study of 746 articles on coronary stents in 2006, we found that the large majority of articles did not include information about funding sources and authors’ financial interests. In the rare instances when authors’ financial interests were disclosed, they were not disclosed consistently. Role of Journals. The inconsistency we observed may be due in part to journal practices. We found that 72% of research articles (excluding case reports) did not identify a funding source and that 83% of all articles did not have a financial disclosure statement for any author. Inconsistencies in financial disclosures for the same authors were due almost entirely to cases in which there was a disclosure statement in one journal and no disclosure statement in another journal. Together, these findings suggest that there are important variations among journals in the handling of information about research support and financial interests. Some journals may simply not solicit or report information about authors’ financial interests. Indeed, some journals in this study never published disclosure statements. Even among journals that sometimes published disclosure statements, we found inconsistencies. This finding is consistent with a recent study in which editors of journals with conflict-of-interest policies reported that they do not publish disclosure statements in every article.16 Role of Authors. Some of the inconsistency we observed is likely also due to the behavior of authors. Only 6% of the 2,985 authors in this study had an article that contained a statement about their financial interests, which suggests that many authors did not disclose their interests. Indeed, in recent cases, authors did not disclose financial interests that were later discovered by others.21,32,33-36 In an informal Internet search on authors in our database for whom no interests were disclosed and for whom there were explicit declarations of no interests, we found evidence that some authors had relationships that many would consider to be conflicts of interest. These relationships included founding a company that manufactures stents, membership on advisory boards of stent manufacturers, and consultancies for stent manufacturers and companies that make drugs related to stent use. Thus, part of the problem with disclosure is the failure of some authors to disclose. We also found 26 cases (involving 16 authors) in which authors disclosed a financial interest in one article but declared they had no financial interests in another article. (This is likely an underestimate of such contradictory statements, because some such authors might have declared they had no interests to a journal that does not report such disclosures, resulting in a “present-absent” comparison.) Almost all of the 26 cases occurred between two research articles, making it unlikely that these apparent contradictions were due to authors or editors believing that a financial interest was relevant for one type of article but not for another. These cases occurred infrequently, but the inconsistency is curious. Our data do not allow us to determine whether the authors intended to mislead. Just as it is unclear how editors decide whether to publish disclosures, little is known about how authors judge the relevance of their financial interests and decide whether to disclose them. Many journal policies rely on authors to determine the relevance of their financial interests. There are at least two perspectives from which an author could judge the relevance of a financial interest. First, the author might try to judge the strength of influence they themselves perceive a financial interest to have. Although authors might have a unique vantage point, this type of introspection is limited, because people are often unaware of all of the determinants of their actions.*37,38 Second, an author might try to judge whether readers or the public would view a specific financial interest as relevant. One problem with adopting this perspective is that some authors might have difficulty predicting what readers would want to know. Based on guidelines and recent media attention,21,33,34,39 a reasonable starting point for these authors might be to disclose relationships with stent manufacturers, companies making products that support stent use, and companies making alternatives to stents. An even more comprehensive strategy would require authors to disclose financial interests in any health care organization.31 Effects of Disclosure on Readers. Guidelines assume that a reader’s discovery of previously undisclosed financial interests has detrimental effects on trust.13-15 This is one consideration that has motivated calls for disclosure of authors’ financial interests. However, little is known about how users of the literature and readers of media reports interpret disclosures and perceive authors’ financial interests. If one purpose of financial disclosures is to allow readers to assess the influence of the financial interests on the overall study, presumably readers would also need to know the role played by the authors with the financial interests. However, we found that only 1.3% of research articles described the contributions of the authors. It is unclear how readers’ attitudes and behaviors would be affected if there were consistent and appropriate disclosures in the medical literature. Disclosures of commercial interests in research have elicited strong negative responses,25,40,41 whereas other work suggests that people do not take disclosures seriously enough.42,43 Studies of financial interests in the context of clinical research show that responses to financial interests are not straightforward and can depend on the type of interest involved.9,44,45 More research is needed to provide a better evidence base for disclosure policies and to clarify how decision makers and the public use and perceive disclosures. Limitations We necessarily restricted the study to articles in a single therapeutic area, so the results may not be generalizable to other areas. We do not have data that allowed us to trace for each article what information was solicited by the journal, what was reported by the author, and how disclosed information was processed by the editors. Moreover, we do not have knowledge of the financial interests that might have been relevant for authors at the time they submitted their manuscripts. Instead, the data we collected were from the perspective of the reader of the medical literature. More data are needed to elucidate the roles played by both journals and authors in producing the inconsistencies we observed. Conclusions Our study is the first to examine the consistency of authors’ financial disclosures in the biomedical literature. We have documented evidence of a system-wide problem with transparency in an area of the literature that has important implications for patient care. It could be argued that an inconsistent system of disclosure is more harmful than no disclosure at all. The current approach creates the impression rather than the reality of transparency and may encourage underestimation of the impact of conflicts of interest on the integrity of medical science. Acknowledgments. We thank Larry W. Diener of Duke University for assistance with database programming; and Michaela A. Dinan of Duke University for assistance with data collection. Mr. Diener and Ms. Dinan did not receive compensation for their assistance apart from their employment at the institution where the study was conducted. We also thank Jean M. Lennon for reviewing a draft of the manuscript. Dr. Lennon did not receive compensation for her assistance. 1 Duke Clinical Research Institute, Duke Translational Medicine Institute, Duke University School of Medicine, Durham, North Carolina, United States of America, 2 Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina, United States of America, 3 Department of Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America Excerpts are reprinted with permission from Weinfurt KP, Seils DM, Tzeng JP, Lin L, Schulman KA, et al. (2008) Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents. PLoS ONE 3(5): e2128. doi:10.1371/journal.pone.0002128 Editor: Tom Tregenza, University of Exeter, United Kingdom Received: March 11, 2008; Accepted: April 3, 2008; Published: May 7, 2008 Copyright: © 2008 Weinfurt et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: Drs. Weinfurt and Califf were supported in part by grant 1UL1RR024128-02 from the National Center for Research Resources, a component of the US National Institutes of Health. Drs. Weinfurt and Schulman were supported in part by grant 5R01HL075538-04 from the National Heart, Lung, and Blood Institute. The funding agencies had no role in the design and conduct of the study; the collection, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript. Competing interests: Dr. Weinfurt reports receiving research and/or salary support from Bristol-Myers Squibb, Inspire Pharmaceuticals, Johnson & Johnson, and Novartis; and receiving personal income for consulting from Inspire Pharmaceuticals. Dr. Schulman reports receiving research and/or salary support from Actelion, Allergan, Amgen, Arthritis Foundation, Astellas Pharma, Bristol-Myers Squibb, The Duke Endowment, Genentech, Inspire Pharmaceuticals, Johnson & Johnson, Kureha Corporation, LifeMasters Supported SelfCare, Medtronic, Merck, Nabi Biopharmaceuticals, National Patient Advocate Foundation, North Carolina Biotechnology Center, Novartis, OSI Eyetech, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, Scios, Tengion, Theravance, Thomson Healthcare, Vertex Pharmaceuticals, Wyeth, and Yamanouchi USA Foundation; receiving personal income for consulting from Avalere Health, LifeMasters Supported SelfCare, McKinsey & Company, and the National Pharmaceutical Council; having equity in Alnylam Pharmaceuticals; having equity in and serving on the board of directors of Cancer Consultants, Inc; and having equity in and serving on the executive board of Faculty Connection, LLC. Dr. Califf reports receiving personal income for consulting from Bayer, Conceptis, and Kowa Research Institute. Dr. Califf also reports that all personal income for consulting is donated to nonprofit organizations, with the majority going to the research fellowship fund of the Duke Clinical Research Institute. Educational activities by Dr. Califf generate revenue for Duke University from Conceptis and Kowa Research Institute. Drs. Weinfurt, Schulman, and Califf have made available online detailed listings of financial disclosures (https://www.dcri.duke.edu/research/coi.jsp ). Mr. Seils, Ms. Tzeng, and Ms. Lin did not report any financial disclosures. Dr. Schulman serves on the editorial boards of the American Heart Journal, The American Journal of Medicine, Cost Effectiveness and Resource Allocation, Health Services Research, and Value in Health. Dr. Califf is the editor in chief of the American Heart Journal and serves on the editorial boards of Cardiosource Clinical Trials; Circulation; Clinical Trials; European Heart Journal; Heart, Lung and Circulation; Journal of Cardiovascular Risk; The Journal of Invasive Cardiology; Journal of the American College of Cardiology; and MedWorks Media. E-mail: kevin.weinfurt@duke.edu

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