Divided Loyalties: Conflicts of Interest in Medicine
Abstract:
Physicians and other medical researchers are the sentries at the portals of life and death. We trust them with that which is most precious to us. In the past, the Norman Rockwell image of compassionate physicians and medical researchers whose sole allegiance was to patients and research subjects who placed complete trust in their care was commonplace. The respect and trust granted to these professionals were commensurate with the role they played. Today, this image has been tainted by conflicts of interest.
In part, the tarnished image is due to changes in the working environment over which physicians and research scientists have little control. No longer are they at the helm of the vessel of life. As two science journalists stated in their book on scientific fraud, Betrayers of the Truth, "the roots of fraud lie in the barrels, not the bad apples that occasionally roll into public view." The same may be said of divided loyalties that pervade modern clinical medicine and medical research.
The authority of physicians and other medical researchers has been eroded as the profession has been transformed into a business model, whereby research and clinical practice are managed and marketed in much the same way as any other commercial product. Consequently, medical professionals often serve several masters--the institution where they work, private industry which provides them with research funding, and research subjects. It has long been acknowledged that "No servant can serve two masters: for either he will hate the one, and love the other; or else he will hold to the one and despise the other."
Modern medicine has provided physicians and other medical researchers with opportunities to enhance significantly their financial interests through entrepreneurial adventures. In some cases, the entrepreneurial temptation has proven too great, and research subjects have suffered as a consequence. Newspaper headlines and journals are filled with articles discussing various types of financial conflicts such as "Teenager's Death is Shaking up the Field of Human Gene-Therapy Experiments" and "Safeguards Get Trampled in Rush for Research Cash." It has been said that "research ethics was born in scandal and reared in protectionism." Today, we are in the throes of rearing the medical, legal, and ethical parameters to deal with financial conflicts of interest in medical research and clinical practice.
Research subjects want to believe that the thoughts controlling decisions, as to which drug to fill the syringe with, are a result of careful consideration of the latest clinical data. It appears, however, that in some instances it is the profit margins for biomedical companies in which physicians or other medical researchers have business entanglements that unduly influence their decisions.
The appropriate approach to take when faced with financial conflicts of interest has been intense, with editorialized pronouncements appearing in the nation's leading medical journals. The entrepreneurial temptation has been quite compelling, with a noticeable trend appearing where academic entanglements with industry appear to be gaining greater momentum over time. In a recent investigation, the Inspector General's Office noted the "[t]ransformation of clinical research into a traditional business model" and documented the often highly unethical and possibly illegal recruitment practices of subjects for clinical trials.
There is no current, comprehensive document or policy guidance for those engaged in health care, medical research, or policy making to review concerning the appropriate means by which to handle conflicts of interest. While there has been excellent review of this subject earlier by several scholars, there is no current publication that takes into account the numerous legislative, regulatory, and policy changes discussed herein that have recently been undertaken to deal with financial conflicts of interest occurring both in the research and clinical settings. The challenge is to develop mechanisms whereby the new pressures, motivations and incentives introduced into medical research and clinical practice by industry involvement can be reconciled with traditional scientific principles and ethical values that promote the public well-being. This is the focus of the proposed project and distinguishes it from previous work.
Because policies and procedures are now evolving in this area, and there is no consensus on what is right and wrong, a comprehensive inter-disciplinary review of the medical and legal literature on this topic first needs to be undertaken, followed by a systematic analysis and critique of existing recommendations, policies, laws, and regulations governing financial conflicts of interest to provide a foundation upon which to make recommendations. The ultimate goal of the proposed inter-disciplinary project is to make recommendations for the legal and ethical management of the physician/researcher/ patient relationship that preserves the integrity of the practice of medicine and conduct of medical research in a competitive medical marketplace.
The project will divide conflicts of interest faced by physicians and biomedical researchers into two major categories:--A) those occurring in research settings and B) those found in clinical practice. The conceptual framework developed as a result of this project will be presented to an interdisciplinary advisory board of national experts, representing the fields of ethics, business law, medicine, and health care management for review and comment. The reviewers' suggestions and critiques will be taken into account in formulating recommendations on how to manage conflicts of interest in the research and clinical settings. Changes in existing laws, regulations, and professional guidelines will be proposed. Final products resulting from the research will include peer reviewed journal articles and a book intended for a university press.