1. Framing the Challenges: Scenarios
You have received a letter from the coordinator of a study to evaluate a new treatment for erectile dysfunction. The letter invites you to submit the names of men from your patient panel who may be eligible for enrollment in the study. You will be paid $150 for every name you provide.
You are an investor in a free-standing, for-profit radiological service that is located down the street from the academic health center by which you are employed. It offers a convenient locale for your patients who do not wish to use the Department of Radiology.
You will soon be "up for tenure" at your institution and need to buttress the scholarly achievements on your curriculum vitae. You are attempting to enlist patients as human subjects in a clinical trial comparing two surgical procedures for ureteral cancer, but find yourself contemplating ways to skew the eligibility criteria so as to enhance the potential for recruitment.
2. Historical, Legal, and Ethical Background
One of the more salient trends in the recent history of the medical profession is mounting concern about conflicts of interest. The advent and evolution of managed care, the spectacular growth of clinical research, increasing pressures to publish: these are among the complex of forces that have generated and perpetuated this concern. It is now commonplace that an individual physician or surgeon may be engaged in multiple activities, from the traditional "troika" of caring for patients, educating students and residents, and conducting to research to such pursuits as holding an interest in commercial organization in the health care "industry." This multiplicity of roles is fertile ground for the genesis of conflicts of interest.
What is a conflict of interest? Thompson defines a conflict of interest as "a set of conditions in which professional judgment concerning a primary interest tends to be unduly influenced by a secondary interest." (Thompson DF. Understanding financial conflicts of interest. New England Journal of Medicine 1993; 329:573-576.) Columbia University's Responsible Conduct of Research web-based program defines a conflict of interest as "a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. An apparent conflict of interest is one in which a reasonable person would think that the professional's judgment is likely to be compromised. A potential conflict of interest involves a situation that may develop into an actual conflict of interest. It is important to note that a conflict of interest exists whether or not decisions are affected by a personal interest; a conflict of interest implies only the potential for bias, not a likelihood." ( http://ccnmtl.columbia.edu/projects/rcr/rcr_conflicts/ )
For physicians and surgeons engaged in the care of patients, it might be more accurate to speak of conflicts of obligation rather than interest: after all, thinking and acting in ways that serve the good of their patients is, within the Hippocratic tradition, their primary obligation or duty. A physician's ability to fulfill that obligation may be compromised by secondary interests. Such secondary interests may be financial in nature or they may be non-financial - for example, personal prestige, academic acclaim, or promotion. For physicians and surgeons whose principal activity is the conduct of basic and/or clinical research, their central obligation or duty is the pursuit of scientific knowledge. Here, too, their ability to do their duty may be undermined by similar secondary interests. Physicians and surgeons who care for patientsand conduct clinical research may - may - be susceptible to conflicts of obligation (or interest, to cite the more widely used term).
Conflicts of interest or obligation are ethically significant and difficult for one overriding reason: they undermine trust - the trust that is central to the fiduciary relationship between physicians and their patients as well as to the integrity of science. Recent history has demonstrated the baleful consequences of such conflicts: patients have suffered physical harm and even death. Even in the absence of such potential or actual physical harms, conflicts of interest or obligation may be harmful to patients, the professions, and society at large. The inherent inequality of power in the patient-physician relationship only buttresses the need for clear principles and rules for reducing, managing, and avoiding conflicts of interest, which serve to safeguard the trust that individuals - and the public - have in physicians and the profession as a whole. In his Resolving Ethical Dilemmas: A Guide for Clinicians (2nd Edition. Philadelphia, PA: Lippincott Williams, and Wilkins, 2000), Bernard Lo provides a useful typology of conflicts of interest or obligation:
- The physician thinks and acts in ways that subordinate the good of the patient to some other interest and, as a result, the patient's good is not achieved and his or her outcomes are worse than (or not as good as) they otherwise would have been.
- The physician's thinking and acting are biased or prejudiced by concern for the secondary interest, without an adverse effect on the patient's outcomes.
- There is potential for an adverse effect on patient outcomes or for biased or prejudiced judgment although there is no evidence of either. This potential arises, for example, when physicians have personal financial investments in health care services and thus have a financial incentive to direct patients to these services.
- In some circumstances - for example, in those in which there is no demonstrable harm or even a potential for harm - the conflict may be perceived. Nonetheless, even perceived conflicts are problematic because they have deleterious effects on trust.
As many observers have noted, although altruism is central to the ethical identity and grounding of medicine as a profession, there is no expectation that physicians and surgeons will be pure altruists in the pursuit of their work with patients; self-interest will play some role in their lives such that they will always have to contend with an internal tension between altruism and self-interest. The difficulty arises when health care reimbursement systems provide financial incentives to physicians such that those incentives distort the physician's judgment of what is best for the patient. Traditional fee-for-service systems could induce physicians to prescribe services that were either in excess of the patient's clinical needs - or not needed at all. Managed care systems, which rely on capitation and prospective payment to control health care costs, can induce physicians to withhold services and care that are ultimately beneficial to the patient.
3. Managing Conflicts of Interest
Disclosure is an essential safeguard and strategy for managing conflicts of interest. As many commentators have suggested, a good self-test for conflicts of interest is to ask oneself this question: Would I be comfortable if my patients learned of my interest, or involvement in X? If one has the capacity for honesty with oneself, and the answer to this question is "yes," then that alone should be illuminating and decisive for the question of how best to manage the conflict - that is, to eliminate it or minimize it, but not to hide it. If the answer is "no," then disclosure can actually be a step in the direction of promoting and improving the trust that is so crucial to the patient-physician relationship. In addition to patients, there are others who are susceptible to abuses of trust by physicians with conflicts of interest: colleagues, students, residents, and the public who look to physicians as authorities on matters of scientific or clinical import also need reassurance that conflicts of interest - arising, for example, out of close ties between a physician and a given industry - are not a source of distortion or bias in the physician's lectures, presentations, or advice. The duty to disclose financial interests is widely recognized and many medical journals now require disclosure, which is also mandated for continuing medical education activities under the accreditation standards of the Accreditation Council on Continuing Medical Education. Gifts from such industries as drug companies should also be disclosed - and, in some cases, prohibited.
Prohibition of certain activities and associations is also a critical component of any comprehensive strategy for managing conflicts of interest. Direct payments to attend meetings, expensive, luxury-oriented gifts, and high-priced entertainment are held to be unethical by several organizations, including the American Medical Association, the American College of Physicians, and the Accreditation Council on Continuing Medical Education. Influence or control over the content of continuing medical education programs on the part of commercial industry, along with selection of speakers or attendees, are also unethical practices. Clinical investigators should not have a direct financial interest in, for example, a therapeutic intervention they are evaluating.
Limits on certain activities or relationships are another tool for managing conflicts of interest. Drug companies that fund clinical research should have no control, whatsoever, over the primary data and statistical analysis of the data generated in the course of a study; investigators should retain the freedom to publish study results, regardless of the nature of those results. Finders fees should commensurate with the services performed by physicians who aid in the recruitment of subjects.
Reaffirmation of the physician's primary obligations - to the good of their patients and to the integrity of the scientific process - is essential to maintaining the trust on which medicine and biomedical science depend.
4. Suggested Solo or Group-Based Activity
Determine what the policies governing conflicts of interest are in your institution. Obtain copies of all relevant policies (that is, for clinical research, publication, etc.). Analyze and evaluate these policies in terms of their scope and robustness. Within your institution, identify the organizational units and individuals who are vested with responsibility for implementing, monitoring, and providing advice and counsel on conflicts of interest; and, from these units and/or individuals, seek information and data on incidence and management of actual, determined conflicts.