This editorial is published together in the Asian Journal of Anesthesiology with the paper “Evidence-Based Recommendations on the Pharmacological Management of Osteoarthritis and Chronic Low Back Pain: an Asian Consensus”.1 The paper is coauthored by one of us, Sun, who is also editor-in-chief of the publishing journal. The work also received support from a pharmaceutical company.
Enters, then, a multifaceted ethical dilemma.
Ethical problems––conflict of interest situations prominent among them––are of high concern to biomedical researchers, policymakers, clinicians, academic journal publishers and editors, industry, universities, and research institutions, as well as healthcare consumers and the general public. This has been especially true since a series of ethical scandals has erupted over the past 40–50 years, some involving prominent medical journals and resulting in media coverage and public outcry such that, for example, the United States Congress ordered hearings on research misconduct.2-5 More than that, quite recent evidence indicates that, despite high levels of attention, there persist serious problems with research ethics and misconduct in biomedical research and publishing, including lack of transparency into conflicts of interest, 6-9 and that it exists in Asia as it does elsewhere.10 Such contributions to the conversation have motivated us to embark on a deep examination of ethical questions regarding this article, and on a revision of our official written ethics policies, informed by some of the excellent guidance available.11-14 An important area in which we’re behind, though it’s not relevant to the particular paper under discussion, is the adoption of a data policy. We have begun to formulate one that is based on PLOS ONE’s comprehensive policy.15
A result of confronting this glaringly problematic ethical case, then, has been occasion to stop and reflect on our ethical values and practices in a deeper, more systematic way, and a resolve to strengthen and modernize our ethics policies. We also slowed and scrutinized our decision to publish the article, to minimize the chance of committing any kind of ethical breach or misconduct. We placed the submission on “trial” and encouraged editorial board members to assume devil’s advocate positions and to dig for and identify any concerns we could dredge up. The investigations were enlightened, we believe, by mindful deep thinking. We engaged the obvious concerns: (Could there be any bias to advance the interests of the industry funder? Were editorial board members inclined to accept the paper because the editor in chief is an author?). And also went beyond them: Did we always look at behaviors instead of personalities (“We know them and know that they’re ethical” was insufficient; Could there be any type of ethical breach or misconduct from any act of omission? What unconscious motives might have been in operation, and could we reasonably conclude that nothing improper therefrom occurred, by applying logic to the consequences we could anticipate as a result of publication?) We required answers to such specific relevant questions instead of simply arriving at a yes or no decision.
We concluded that, whatever may have been in the minds of the papers’ authors, the recommendations made do not appear to serve the interest of the industry funder in any direct or indirect way we could identify or imagine, nor could we find evidence that there was any bias toward that end. The funding firm primarily offers opioid products at present, and we adjudged that the content of the paper is clearly on the conservative side of the contemporary debate among scholars and practitioners on recommendations as to when opioids might appropriately be used. In fact, there is well-reasoned sentiment that opioids should be brought much further into the foreground, as potentially useful treatment considerations for some people with conditions like those we studied, when other treatment medications or modalities prove inadequate. 16,17
We also dissected the question as to whether or not the paper could have been improperly accepted for publication because one of us, Sun, is editor-in-chief of the publishing journal. On review among our editorial board, we comfortably concluded that the article does not improperly impose any constraint or requirement on clinicians, that its recommendations and conclusions are based on the application of good and rigorous scientific principles, and the decision to publish was reached by a careful and deliberate consensus within the editorial board: the potential for bias in the peer-review process was vigorously challenged, with Sun recusing himself from the decision. In addition to evaluating the scientific soundness of the process and product, editors were specifically asked to determine if the paper was likely to represent a novel and significant contribution to the field of anesthesiology; it was so determined by a consensus, with Sun recused.
Our paper presents not any kind of official or binding guideline. We propose it as a set of recommendations which we hope will serve as a base for discussion and development in an area that has received insufficient attention: pharmacotherapy for osteoarthritis and chronic lower back pain in a number of countries that represent a substantial part of Asia.
We publish the paper with pride. Reason demands that we recognize that there must be doubt as to potential biases in this situation, as with any involving competing interests, and that includes unconscious biases, rationalizations and incorrect beliefs that human beings regularly make. We believe we have employed sufficient transparency to let our readers decide, and to expose our decisions and our work to public scrutiny. Our guiding interest, from inception to publication decision, aims to support healthcare researchers, clinicians, policymakers, and the publics that we serve. We endeavored to achieve that primarily by employing transparency into every aspect of the process where we could discern any potential ethical failure, especially where they may arise from competing interests.
Yabuki S, Ip AKK, Tam CK, et al.
Evidence-based recommendations on the pharmacological management of osteoarthritis and chronic low back pain: an Asian consensus.
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