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AJR 2006; 186:609-610
© American Roentgen Ray Society

Conflict of Interest in the Medical Literature

Robert J. Stanley, Editor in Chief

rstanley{at}ajroffice.org

One can hardly pick up a newspaper today without reading something about conflict of interest (COI) in corporations, in government, and in our health care institutions. In academic institutions and hospitals, the conflicts often arise from relationships between individuals (physicians and administrators) or institutions (universities and hospitals) and external companies, and they nearly always involve money, a driving force in coloring human behavior. The concern is whether money or in-kind payments from the external company to individuals or to institutions color their judgment in making decisions. The activities that individuals and institutions engage in include, for example, consulting, purchasing, research and publishing, choosing and training students and fellows, allowing company use of institutional resources (space, equipment, name, patients, faculty), licensing and sale of institutional and individual technology with resulting royalties, and other institutional intellectual property activities. The payments might be money paid to individuals, trips and related expenses, entertainment, educational or research grants to the institution or individual, or favorable purchase terms tied to benefits to the vendor company. The decisions might be about the data that will be published or not published; the vendor and type of equipment and supplies that will be purchased; the selection of students who might contribute to the activity in question; the selection of patients for clinical trials and what they are told about the financial relationships; or the choice of therapies, devices, or drugs that are prescribed for patients. Individual and institutional conflict of interest policies, sometimes driven by headlines of scandals, are now being reviewed and revised at national and local levels to address the issues and the public concern. The problem is confounded by the fact that some of the relationships are uniquely valuable in advancing medical science and education and by the belief held by many individuals and institutions, whether accurate or not, that the money does not influence the integrity of the decisions or the integrity of the data.

Let's explore some realistic conflict of interest issues that could arise in the course of the submission of a manuscript to the AJR, resulting from the following hypothetical cases.

  1. The author has a financial relationship with the company that sells a device or drug. For example, the author might hold stock in the company, might be a paid consultant for the company, or might be the inventor of the drug or device and in line to receive royalties. The company provided the funds to support the clinical trial conducted by the author. Favorable results from the trial could increase the success of the product and increase the financial returns to the author. In our world, the author might be, for example, the inventor of a coil for closing cerebral artery aneurysms who has conducted the clinical trial on the coil and is ready to publish the favorable results. One might wonder whether the patients were chosen and assigned to experimental and control groups appropriately; whether the patients were appropriately advised regarding their informed consent; whether the protocol was designed without bias; whether negative results were suppressed; and whether data were correctly interpreted and represented.
  2. Same scenario as number 1, except the author has no financial relationship. Rather, the institution or high-level administrators have a strong financial relationship with the company that sponsored the research, and the financial returns, if the data are favorable, might fund programs and salaries in the author's department. Could this situation bias the reporting of the results of the trial?
  3. The author has close personal ties with individuals in the company that is sponsoring his or her research on contrast agents or imaging devices. These ties have been cemented by golf outings, speaking trips around the world, the loan or gift of expensive equipment or supplies for the laboratory, and an educational grant to support a fellow. Can the author conduct the research and interpret the data free of even the most subliminal bias?
  4. The reviewer for the AJR has a financial relationship with the company sponsor of the proposed article as a paid consultant, a compensated speaker, or a stockholder; or the AJR reviewer was involved earlier in a related research project, the academic standing of which might be affected by the outcome of the new publication. To what extent might such situations affect the review?
  5. The book reviewer who submits a review of a new book is the author of a competing book or has a financial relationship with either the publisher of the new book or with a competing publisher. The review could increase or decrease financial returns to the book reviewer, depending on the circumstances. Can the review be done without bias? And how do we know if such a conflict exists?

In the world of medical publishing, the methods for dealing with conflicts of interest vary. The International Committee of Medical Journal Editors (ICMJE), in their "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication" [1] addresses the issue of conflict of interest as follows:

Public trust in the peer review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision making. Conflict of interest exists when an author (or the author's institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from those with negligible potential to those with great potential to influence judgment, and not all relationships represent true conflict of interest. The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgment. Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion.

All participants in the peer review and publication process must disclose all relationships that could be viewed as presenting a potential conflict of interest. Disclosure of these relationships is alsoimportant in connection with editorials and review articles, because it can be more difficult to detect bias in these types of publications than in reports of original research. Editors may use information disclosed in conflict of interest and financial interest statements as a basis for editorial decisions. Editors should publish this information if they believe it is important in judging the manuscript.

How do we at the AJR deal with conflicts of interest? In the AJR Author and Submission Information, we indicate that we follow the guidelines of the ICMJE. Further, the AJR copyright form requests that the author(s) certify that:

The editor of the American Journal of Roentgenology has been or will be informed of any proprietary or commercial interest or conflicts of interest the authors may have that relate directly or indirectly to the subject of this article. This information must be noted in the cover letter submitted with the article.

Does this cover the responsibility and solve the problem of potential conflict of interest for the Editor in Chief? I am unsure whether it does, and I am unsure that the editor can effectively police conflicts of interest or whether that is an appropriate role. Should we ask for a statement from the author's institution, certifying that the institution knows about and is managing the conflict of interest to protect the integrity of the data? Do journals contribute to conflicts of interest by a tendency to publish only positive results? Is the integrity of the journal at risk from detrimental conflicts of interest? Is disclosure that a financial relationship with the sponsor exists enough, or should the "full" disclosure provide more details that allow the reader to assess the potential for bias? When is the conflict of sufficient magnitude to cause the editor to reject the paper, and does the AJR receive enough information to make that judgment? Are we doing all we can to report only accurate data for the benefit of our readers, the public, and our patients?

At a time when the integrity of the medical profession is being carefully monitored and rated, and the harm of undisclosed and unmanaged conflicts of interest can be multiplied first by newspaper reports of scandals and second by the medical media reporting on medical "breakthroughs" later shown to be ineffective or harmful, we can all agree that every effort should be made to strengthen the value and accuracy of the medical literature. Clinically oriented medical journals theoretically present applied science ready for implementation and based on the validation of the peer reviewers. The proof of the science is not determined over years of careful usage and duplication, but rather in the brief time required for the review. Thus, the onus is on the editorial staff to reasonably assure the truth within human limits.

The AJR editors and staff, in concert with the Publication Committee and the Editorial Policy Subcommittee, will study the current policy of the journal and our sponsoring society, the American Roentgen Ray Society, regarding the issue of conflict of interest, the potential risks and implications if the policy is not as clear as it might be, and the responsibility of the Editor in Chief in reasonably monitoring adherence to the policy. Meanwhile, the journal can serve as an excellent venue for our readers to debate the issues raised by this complex topic.

Selected Reading

  1. Charlton BG. Conflicts of interest in medical science: peer usage, peer review and CoI consultancy. Med Hypotheses 2004; 63:181–186
  2. Holmes DR Jr, Firth BG, James A, et al. Conflict of interest. Am Heart J 2004; 147:228–237. Available at: http://uuhsc.utah.edu/ethics/RCREthics/Holmes%20et%20al_COI.pdf. Accessed January 23, 2006
  3. Journal Watch Online. The Journal Watch & Clinical Care newsletters conflict of interest policy (updated 2/13/04). Available at: http://www.jwatch.org/misc/conflict.shtml. Accessed January 23, 2006
  4. Krimsky S, Rothenberg LS. Conflict of interest policies in science and medical journals: editorial practices and author disclosures. Science and Engineering Ethics 2001; 7:205–218. Available at: www.tufts.edu/~skrimsky/PDF/conflict.PDF. Accessed January 23, 2006
  5. Krimsky S, Rothenberg LS. Financial interest and its disclosure in scientific publications. JAMA 1998; 280:225–226. Available at: www.ama-assn.org/public/peer/7_15_98/jpv71010.htm. Accessed January 23, 2006
  6. Mayor S. Surgery journal bans authors who hide conflicts of interest. BMJ 2006; 332:135; doi:10.1136/bmj.332.7534.135-a
  7. SourceWatch, a project of the Center for Media & Democracy, Web site. Medical journals and conflicts of interest. Available at: www.sourcewatch.org/index.php?title=Medical_Journals_and_Conflicts_of_Interest. Accessed January 23, 2006


References
Top
References
 

  1. International Committee of Medical Journal Editors (ICMJE).Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication . Updated October2005 . Available at: www.icmje.org/#conflicts. Accessed January 23, 2006

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This Article
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