© Springer-Verlag Berlin Heidelberg 2014
Ahmed Ammar and Mark Bernstein (eds.)Neurosurgical Ethics in Practice: Value-based Medicine10.1007/978-3-642-54980-9_2020. Conflict of Interest
(1)
Section of Neurosurgery, Department of Surgery, Winnipeg Children’s Hospital, University of Manitoba, Manitoba Institute of Child Health, GB-138, 820 Sherbrook Street, Winnipeg, MB, R3A 1R9, Canada
20.1 Introduction
Conflicts of interest are encountered in all aspects of life, both professional and personal. For the purposes of physicians involved in clinical care and/or research, a conflict of interest is defined as “a set of conditions in which professional judgment concerning a primary interest tends to be unduly influenced by a secondary interest.” (Thompson 1993). In the case of a neurosurgeon in practice, the primary interest is usually the welfare of an individual patient, but secondary competing interests may be financial gain, the integrity and validity of a research project, or the teaching of residents, medical students, and other trainees. Although most people think of financial gain as the most likely secondary interest, other interests can serve in that role, including academic advancement, prestige, both personal and institutional, and promotion. Personal factors can also serve as a secondary interest, such as spending time with family, hobbies, and the need for rest. The dual loyalties of a surgeon-scientist can be particularly difficult to navigate (Bernstein 2003), where the primary interest in patient care and outcomes can be tested by a surgeon’s role in an ongoing research project.
Institutions such as hospitals and universities can also have conflicts of interest where the primary interest in patient care or knowledge acquisition and dissemination are in conflict with secondary interests relating to funding and competition for patients, among other things.
The mere presence of a conflict of interest, however, does not necessarily indicate immoral or unethical behavior; in fact, it is impossible not to have conflicts of interest of one form or another (Bernstein 2003; Emanuel and Thompson 2008). It is how one acts in the context of a particular situation that may be cause for concern (Lemmens and Singer 1998).
Although some talk of potential or perceived conflict of interest versus actual ones, a conflict of interest refers to a tendency, not an actual occurrence – “it exists if the individual or institution is making decisions under circumstances that, based on past experience, tend to lead to distortions in judgment” (Emanuel and Thompson 2008).
At the heart of discussions of conflict of interest is the concern that poorly managed, they can erode the trust the public in general and patients specifically have in the care they are given and the integrity of scientific research. The bioethical underpinning of concerns regarding conflicts of interest stems from the principle of non-maleficence, which is central to value-based medicine. If secondary interests are allowed to supersede the primary interest of patient care, there can be a significant risk of harm to the patient.
Pearl
Conflicts of interest are ubiquitous and unavoidable. The presence of a conflict of interest does not necessarily mean immoral or unethical behavior as long as it is dealt with properly.
20.2 Illustrative Case (Financial Enticement to Try New Spine Instrumentation)
As a busy neurosurgeon with a subspecialty interest in spinal neurosurgery, you are invited to a symposium by a device manufacturer who is developing a new product for minimally invasive spinal fusion. At the symposium, a prominent colleague, who was involved in the design of the device, speaks eloquently on the possible merits of the device relative to the current standard of care and presents preliminary data suggesting high fusion rates, low complications, and shorter hospital stays. You are asked if you would be willing to participate in a trial of the new device, where you will be taught how to use the new system and enroll patients in the proposed trial, with the ultimate goal of regulatory approval of the device. For each patient you enroll, you will receive $6,000.00 to support the hiring of a research assistant and other infrastructure costs of participation. It is suggested that you could also be an author on a publication that may result from the trial.
20.3 Approach to the Case
The first step to managing a conflict is awareness of its presence, and the illustrative case above presents a number of examples where a conflict exists. First, does the invitation to the symposium come with a monetary benefit such as travel expenses, accommodation, meal, and an honorarium for participation? Second, what is the relationship between the speaker(s) and the device manufacturer – do they receive financial compensation in any way or stand to benefit from the success of the device? This can include honoraria, consulting fees, royalties, or an equity or ownership stake in the company. Third, is the per patient enrollment fee excessive, that is, is it likely to exceed the actual cost of hiring a research assistant and maintaining a research infrastructure? Fourth, who controls the data derived from the study, how is it analyzed, who decides whether or not it is published, and is there an independent review of adverse events? Finally, does your participation in the trial warrant authorship?
In general, when a conflict of interest is present, it can be managed by a variety of means, ranging from voluntary disclosure to authorization by a third party to prohibition. Disclosure means making potentially interested parties aware of the conflict. This may include patients or research participants, Institutional Review Boards or IRBs (also known as Research Ethics Boards or REBs), journal editors when papers are submitted for publication, and your own hospital or university. Authorization by a third party can often follow disclosure, where the policies of an IRB, hospital, government agency, or university determine whether the conflict is allowed. Prohibition, the most extreme approach to conflicts of interest, prohibits certain relationships between industry and physicians.
20.4 Discussion
20.4.1 Industry and Neurosurgery
Although there are many sources of conflicts of interest encountered by neurosurgeons, it is the relationship between industry and neurosurgery that is most likely to introduce bias and undermine patient and public trust in our specialty. Nowhere does that relationship play a larger role than in the interactions between neurosurgeons and industry in research.
Funding from industry plays an increasingly important role in biomedical research. Industry-sponsored research now accounts for over half of all funding at over $60 billion per year (Moses and Martin 2001). The percentage of industry funding as a percentage of total research funding increased from 27 % in 1977 to 58 % in 2008 (Raad and Appelbaum 2012). There are concerns that the abundance of industry-funded research leads to bias – industry-sponsored research is more likely to yield positive “pro-industry results” (Bhandari et al. 2004), and there are examples where negative results have been suppressed or attempts made to suppress them (Moynihan 2010). A 2003 review of studies on the relationship between industry and medical research showed that 25 % of investigators had industry affiliations and two-thirds of academic institutions had an equity interest in companies that sponsored research at their institution (Bekelman et al. 2003).
In 2008, the president of the American Association of Neurological Surgeons (AANS) devoted his entire Presidential Address at the Annual AANS meeting to concerns about the relationship between industry and neurosurgery (Robertson 2008). He highlighted the role and conflict present in industry-funded continuing medical education but devoted most of his address to industry-sponsored research in neurosurgery and the relationship between industry and neurosurgical researchers.
Pearl
Industry involvement in neurosurgery, through continuing medical education, research funding, and device development, introduces many opportunities for conflicts of interest.
20.4.2 Disclosure
Voluntary disclosure is the most common approach to dealing with conflicts of interest. In neurosurgical research, the Journal of Neurosurgery Publishing Group, like most journals, requires that authors of submitted papers to disclose the source of funding (be it government and not-for-profit funding agencies or industry funding) as well as any other financial conflicts, including consulting fees, royalties, stock holdings, or ownership stakes in device manufacturers or pharmaceutical companies (Journal of Neurosurgery Publishing Group 2008). These constitute what is known as “simple disclosures” where the actual dollar amount involved is not indicated. Disclosure of conflicts of interest allows reviewers and ultimately readers of journal articles to decide if the nature of the conflict of interest is strong enough to bias the results of the study. Review of disclosure rates in the Journal of Neurosurgery in 2011 revealed that 35 % of published papers disclosed some type of conflict of interest.
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