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Editor`s Opinion: Removing the "Un" from the Law of Unintended Consequences
Once upon a time, we lived in a world where clinicians provided patient care and researchers explored new ways to provide that care. Editors read the work they received and publishers published. Also in this world, patients presumed the care they received was based on the best science available at that time and clinicians believed that what they read and learned was accurate and objective.
Researchers presumed the support needed for their work would flow from the obvious need identified by clinicians and fellow researchers; patients who participated in that research presumed they were helping others (if not themselves). Editors presumed all information they received was accurate and objective, and publishers thought their role in the process of disseminating this important information would continue to be supported by loyal readers and by advertisers of products/services needed by readers.
In our newer world, everything has changed, including the process by which we obtain and share the clinical information on which you, our readers, rely. The presumptions of the past have been replaced with distrust and insecurity, as well as many guidelines, laws, and directives. Many patients enter the world of healthcare armed with a wealth of (mis)information. Clinicians may themselves be researchers. They have learned not to presume that all information is accurate, up-to-date, objective, and/or consistent with the latest guidelines of care. The researcher who is able to spend a lifetime (or even a few years) dedicated to answering one or two questions without worrying where the funding will come from has gone the way of the house call.
Patients participating in research also don’t make presumptions. They have heard enough about scientific fraud and medical mistakes in the popular press to be cautious and careful. Any remaining presumptions will surely vanish as they read the consent forms. Finally, editors who have not implemented a strict peer-review process, who do not rely on their editorial staff and advisory board members to make publication decisions and on their readers to write letters, are not (hopefully) editing medical journals. While this entire effort is appreciated by loyal readers, the increased need and demand for scientific integrity comes at a price to publishers who have to deal with increased costs and a redirection of advertising dollars (eg, to direct consumer advertising).
On the surface, the changes that have occurred during the past few decades and the mass (and maze) of current rules and regulations appear to be more than sufficient to guide us. The last things we seem to need are new guidelines on protecting human subjects in research and more concerns about publication sponsorship, data integrity, authorship, accountability, plagiarism, and duplicate publication.1-4 Yet that is exactly what is happening. Moreover, although seemingly unrelated and very different in scope and focus, the new research and publication guidelines attempt to address similar concerns: bias, undue influence, and ethics. These developments remind us that, even in this changed world, we can still count on the law of unintended consequences.
Before passage of the Bayh-Dole Act in 1980, federal regulations prohibited researchers and universities from retaining the ownership of patents when inventions were developed with the use of federal funds. As a result, an inventor-entrepreneur-researcher-clinician did not have a vested interest in the success (or failure) of an invention. While the Act was designed to increase technology transfer, the unintended consequence was the creation of potential conflicts of interest between what is good for the patient and what is good for the inventor/entrepreneur/employer. As Dr. Kelp points out, "One cannot work simultaneously as an inventor-entrepreneur and a physician or other healthcare provider and maintain the trust of patients and the public."1
The soon-to-be published new "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" also attempts to address the issues of bias, undue influence, and ethics because, "The objective exchange of information in scientific journals… is vital to the scientific practice of medicine because it shapes treatment decisions… and drives public and private healthcare policy."2 Why is there a need to expand existing conflict-of-interest guidelines? First, careful review of the literature and studies involving the research process (yes, they do exist) show that research agreements limiting clinicians’ access to study design, raw data, and interpretation of the data have increased. In other words, the author of the publication should, but cannot be, responsible for the work reported. Second, publication bias, plagiarism, and duplicate publication (ie, publishing the results of the same study twice) are more common than previously thought. Although not intended to uncover bias and ethical problems, the evidence-based care movement and our ability to access and search medical literature databases made it easier to find those who plagiarize and submit duplicate publications. It also brought the issue of how publication bias affects our ability to provide optimal care into focus. How can we make treatment decisions and provide evidence-based care if most information published about a treatment modality is "positive" and the number (if any) of "negative" studies is unknown?
Last, but not least, the law of unintended consequences also applies to journals. Publications whose editorial staff appear to be subject to undue influence now can be uncovered with the click of a mouse. The Uniform Requirements are very specific about "commitments of editors, journal staff, and reviewers." Clinicians, researchers, readers, reviewers, editors, and publishers may miss the days when we presumed that everyone was doing the right thing for the right reasons. However, given the increase in diagnostic and treatment options, patients surely won’t mind our attempts to guard the integrity of the process that affects their care. Change is inevitable. The effect of changes on all parts of a system is inevitable. The trick is to anticipate the inevitability of the law of unintended consequences and to remove the "un!"
1. Kelch RP. Maintaining the public trust in clinical research. N Eng J Med. 2002;346(4):285-287.
2. Davidoff F, DeAngelis CD, Drazen JM, Hoey J. Sponsorship, authorship, and accountability. N Eng J Med. 2001;345(11):825-827
3. Drummond R, Gunsalas CK, Wronski M, Johnson R. International plagiarism - does authorship stop at the border? CBE Views. 1999;22(6):187
4. Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress - policy and guidelines for the oversight of individual financial interests in human subjects research. Washington, D.C.: Association of American Medical Colleges, December 2001. Available at: http://www.aamc.org/members/coitf/. Accessed February 3, 2002.
