Title: Full Disclosure: Conflict of Interest in Scientific Publications
Abstract: “To be persuasive we must be believable; to be believable we must be credible; to be credible we must be truthful.” —Edward R. Murrow Science—and medicine as a subset of science—in its pure and ideal form is a dispassionate pursuit, free from financial and/or political forces. Similarly so, the enterprise of biomedical publication aspires to the ideal that it will—in a nonpolitical and nonfinancially motivated fashion—promulgate clinical and basic science findings for the benefit of patients, the education of doctors, and the furthering of research. At its core, scientific publication is based on honesty: the honest, clear reporting of findings, whether positive or negative, conclusive or open-ended. Although such utopian thoughts should and do guide us, we live in a world full of political, financial, and institutional interests that compete not only against each other but also against the ideals we cherish. For example, pharmaceutical and medical device manufacturers are genuinely interested in helping patients. However, they also have enormous financial interests in the drugs and devices they make to help precisely those patients. These companies rely on academic biomedical scientists to provide them with necessary research to develop and improve on their drugs and devices.1 For these legitimate, needful, and helpful services, the scientists are compensated by the drug and device manufacturers. But in doing so, their scientific work and reporting of results become entangled by financial interests. The question arises: Is their scientific objectivity—their honesty—compromised or influenced by their connection to money? What can be done when the ideals of biomedical publication confront the necessities of the real world? In biomedical publication, the primary way to address the concern of financial involvement is through full disclosure of conflicts of interest. Progress in biomedical research results from a complex interdependent relationship among investigators, academic institutions, funding agencies, and industry. This relationship has largely been positive.2 Disclosure is the process whereby authors of manuscripts reveal their financial relationship(s) with manufacturers of any drugs or devices that are stated or discussed in their articles, or their relationship with companies that manufacture drugs or devices that are related to or compete with those mentioned in their articles. Disclosure is simply the stating of that information. Disclosure of financial ties does not equate with disqualification of an author to publish an article, nor does it undermine an author’s credibility. In fact, just the opposite occurs with disclosure: disclosing financial relationships increases the credibility, trustworthiness, and legitimacy of an author. Disclosure provides transparency in the relationship of science, money, and politics; it acknowledges the role that each party has played in the generation, interpretation, and reporting of new knowledge and, it is hoped, further enhances the confidence that the scientific community and the profession have in the articles published in the biomedical literature.2 Disclosure enables reviewers, editors, and readers to evaluate for themselves potential biases that may be inherent in an article. THE STATE OF DISCLOSURE: CURRENT EVENTS The current climate is one of increasing academic and public scrutiny of disclosures or, perhaps more accurately, the lack of disclosures and overall honesty on the part of authors of scientific studies. A commentary in the June 9, 2005, issue of Nature suggested that “U.S. scientists engage in a range of behaviors extending far beyond falsification, fabrication, and plagiarism.”3 This survey-based study revealed a wide range of questionable practices engaged in by a large number of authors. With authors stratified by career stage (early career, mid career, and all authors combined), the study found 16 questionable, dishonest, or otherwise unethical behaviors. Of special note, not properly disclosing financial involvement in firms whose products were based on the author’s own research was practiced by 0.4 percent of survey respondents. Much more alarming, 20.6 percent of midcareer scientists admitted to changing the design, methodology, or results of a study in response to pressure from a funding source.3 That one in five midcareer scientists bows to financial pressures and changes crucial elements of their articles casts a damning shadow of doubt and incredulity on the integrity of science. Events that have occurred in last few months support and reinforce the findings in the Nature study. Beginning in November of 2005, a widely publicized scandal involving scientific misconduct and misreporting focused on South Korean cloning scientist Hwang Woo Suk. Revelations that he fabricated his evidence led to numerous investigations into the overall credibility of scientific research and the peer review process of biomedical publications.4 Recent investigations into the clinical trials and approval for certain cyclo-oxygenase inhibitor drugs has uncovered methodological and reporting flaws and previously undisclosed financial involvement on the part of the clinical investigators. On the issue of financial disclosure, such eminent biomedical journals as JAMA and Neuropsychopharmacology were misled by researchers who failed to reveal financial ties to drug and device companies, with JAMA having three instances of such lack of disclosure in 2 months’ time in 2006.2,5–10 In response to the public outcry over scientific misconduct, especially the lack of financial transparency and appropriate financial disclosure from authors, many journals have issued editorials and articles on the importance of financial disclosure and updated their disclosure policies.2,11–13 The Journal of Clinical Periodontology now requires that all submitted manuscripts provide disclosure of funding sources and potential conflicts of interest. In addition, it will print a statement of funding and a conflict of interest statement with its articles.2 A commentary in Lancet proposes imposing heavier responsibilities on all institutions and their leaders for ensuring ethical and sound research environments.11 The editor of Arthritis and Rheumatism has updated that journal’s policies so that upon acceptance of a manuscript, each author is now required to complete the entire author disclosure form and initial each page of the form and sign the final page of the form. In addition, all manuscripts with commercial support are now required to include a statement in the Methods section describing the role the sponsors played in the generation of the manuscript.12 In similar fashion, JAMA announced new disclosure and conflict of interest policies, requiring complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value.13 In addition to announcing new policies, some journals have also published lists of potential consequences for those who violate disclosure guidelines. Arthritis and Rheumatism lists the following potential consequences12: Warning letters; Refusal to publish the article in question; Retraction of a published article; A statement of loss of confidence; Notification of the author’s primary institution; and Exclusion from publication in the journal for a specified time frame. The journal Environmental Health Perspectives will impose a 3-year ban on publication for authors who willfully fail to disclose financial links; it also may retract studies if it determines that unreported conflicts would have prompted it to initially reject the manuscript.10 Similarly, the Journal of Thoracic and Cardiovascular Surgery indicated it would start to ban for “some period of time” authors who fail to disclose conflicts.10 Catherine DeAngelis, editor-in-chief of JAMA, also asks medical school deans employing researchers to investigate and impose their own internal sanctions.10 It is clear that publishing errata is no longer sufficient for willful disclosure and conflict of interest violations. PLASTIC AND RECONSTRUCTIVE SURGERY AND DISCLOSURE Given the events that have occurred with other biomedical journals, readers may have concerns about conflicts of interests regarding the authorship of articles appearing in Plastic and Reconstructive Surgery. As with other specialty journals, many of the experts in the various subspecialty fields within plastic surgery—those who have the deepest scientific understanding of drugs and devices and who possess the most extensive clinical experience working with them—are the same people who have helped research and develop those same drugs and devices and who now own stock in the companies that manufacture them. What safeguards does the Journal take to make sure that full disclosure is accomplished and that author involvement in products and companies is made evident? For years it has been Plastic and Reconstructive Surgery’s policy to have all authors state any financial connections to the manufacturers of any products or devices described in their articles. This policy was initiated years ago and is endorsed by the American Society of Plastic Surgeons, the parent organization of Plastic and Reconstructive Surgery. Figure 1 shows our new and more comprehensive “Conflict of Interest Disclosure Statement” required for every article that is submitted to the Journal. This statement must be signed by all authors of each manuscript.Fig. 1.: Conflict of interest disclosure statement for Plastic and Reconstructive Surgery.Supplement articles are no exception. In fact, a “double disclosure” is required for all supplement articles. This means that a separate financial disclosure page (indicated on the Table of Contents), providing all disclosures of all the authors in a supplement, is printed at the front of the supplement. Second, each article has its own financial disclosure statement, clearly indicating any financial connection the authors of that article may have to the products or devices described therein.14 In reviewing disclosure statements from the supplements of a number of other prominent clinical journals, it is evident that Plastic and Reconstructive Surgery provides one of the most comprehensive and prominent disclosures in medical publishing. With disclosures in supplements, this Journal is clearly a leader in the field in this regard.14 In addition, we have recently updated our Information for Authors. Included in that information is the following submission requirement for all manuscripts: FINANCIAL DISCLOSURE AND PRODUCTS PAGE On the third page of the manuscript, all sources of funds supporting the work and a statement of financial interest, if any, must be included for each author, along with a list of all products, devices, drugs, etc., used in the manuscript. All manuscripts must have all of this information. Each author must disclose at the time of submission any commercial associations or financial relationships that might pose or create a conflict of interest with information presented in any submitted manuscript. Such associations include consultancies, stock ownership, or other equity interests, patent licensing arrangements, and payments for conducting or publicizing a study described in the manuscript. This information will be printed with the article. While the Journal will do all it can to obtain and publish complete financial and conflict of interest information for all authors, it is not our task to serve as detectives.4 The Journal and I expect authors to be forthright in their financial declarations and industry associations. Plastic and Reconstructive Surgery will continue to refine its policies to keep in step with other biomedical journals, and if necessary, we will begin to impose penalties on those who violate stated policies. I hope that such steps will not be necessary. We realize that a journal is only as good as its scientific integrity and the honesty of the authors, so we implore every author to disclose any possible relationship or financial involvement with the products mentioned in their articles. Ultimately, financial disclosure boils down to a matter of an author’s honesty and integrity. Honesty truly is the best policy. “Honesty is like an icicle; if once it melts that is the end of it.” –-American Proverb