Conflicts of interest and the clinical engineer

Abstract

Clinical engineers should be aware of the heightenedpublic concern and legal scrutiny regarding conflicts of interest which increasingly arise between members of the medical community, private industry and sources of federal funding. Such conflicts appear whenever medical scientists hold a vested interest in the success and sale of a biomedical product they have developed or upon which they have performed research. Conflicts of interest most commonly appear when scientists serve as consultants, stockholders, board members, officers or investors to corporations, partnerships and joint ventures for which they perform research and from which they receive funding for any purpose. In order to forestall further abuse of the public interest and minimize the intrusion of litigation into this arena of biomedical technology, clearly drawn guidelines or codes of ethics should be promulgated by universities, professional associations, research institutions and private industry. In a utopian world, scientists would work exclusively toward the betterment of the human condition, the advancement of science and the achievement of excellence in their chosen fields. In the real world, however, recent advances in biotechnology have combined with several factors to initiate a downward spiral in the ethics of medicine and finance, or "medi-financial ethics", to coin a new phrase. These factors include: The growing number of physicians who are heavily concentrated in urban and suburban areas; reduced Medicare and Medicaid dollars for inpatient payment; increased reliance on outpatient settings for the delivery of care, and new biotechnologies which make outpatient care a viable clinical option for an increasing number of treatments.' A progressively tight federal budget has sharpened incentives for intimate courtships between universities and private industry in the undertaking of research2, animal and human testing', referrals', selfreferrals' and advertising6. No longer is it uncommon for physicians and clinical engineers, who often hold hospital staff or university faculty positions, to have vested financial interests which inherently make their scientific work less than objective. Conflicts of interest most commonly arise when scientists serve as consultants, stock holders, board members or officers to corporations. Moreover, a conflict of interest exists'a priori when the scientist endorses a product through publication of a favorable study and he or she receives funds in any form from the product's manufacturer'. The same is true when the scientist serves as a faculty member to or accepts grant monies from a corporation. By definition, conflicts of interest arise when scientists serve as partners, joint venturers', owners or even slight investors in corporations, including "faculty corporationsg." Despite the addition of the Anti-Fraud and Abuse statute" to Medicare'' and Medicaid" laws in the late 1980's. Congress believed it necessary to hold subsequent hearings to examine the increasingly deleterious effects medi-financialconflicts of interest may have upon the consumers' health and pocketbook. Congress does not act alone in taking prophylactic steps to diminish the appeal of vested interests which arise out of conflict situations. For example, both the National Institute of Health and the National Science Foundation are in the process of draftingconflict of interest policies for scientistswho seek federal grants. Their guidelines will be designed to prevent physicians and clinical engineers, among others, from using grants to further private interest^'^. A number of universities also have taken measures to prevent further abuses of the medi-financial system. For example, at Johns Hopkins and the Massachusetts Institute of Technology, professors are forbidden to own stock in companies which support their re~earch. '~ The orthopaedics department at Loma Linda University currently is working with representatives from the private sector to produce guidelines regarding acceptable and proscribed conduct for the interaction between university scientists and private industry sector. Surely other institutions will follow the lead of these universities in structuring guidelines that will assist in minimizing conflicts of interest and will promote