Conflicts of Interest among Physicians: Definition and Scope of the Problem
Conflict of interest can be defined as “A set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest”, where the primary interests include “promoting and protecting the integrity of research, the welfare of patients, and the quality of medical education”; and secondary interests include “not only financial gain but also the desire for professional advancement, recognition for personal achievement and favors to friends and family or to students and colleagues.” (Conflict of Interest in Medical Research, Education, and Practice. Institute of Medicine, 2009, page 38-39; http://books.nap.edu/openbook.php?record_id=12598&page=38)
“Although the principle that the integrity of decision making should not be undermined by self-interest may seem self-evident, not until the 1960s was this concept applied to government office holders and attorneys, and then sporadically in the 1980s and 1990s to physicians and clinical researchers.” (Rothman 2008, JAMA; http://jama.ama-assn.org/cgi/content/full/299/6/695)
Conflicts of interest in clinical care can arise at the level of the individual physician or that of the institution. Academic medical centers and professional medical societies are only now beginning to address many of the critical issues involved in institutional conflicts of interest (Rothman DJ, JAMA, 2008 http://jama.ama-assn.org/cgi/content/full/299/6/695). “Institutional conflicts of interest arise when an institution’s own financial interests or the interests of its senior officials pose risks to the integrity of the institution’s primary interests and missions”. (Conflict of Interest in Medical Research, Education, and Practice. Institute of Medicine, 2009, page 176; http://books.nap.edu/openbook.php?record_id=12598&page=176)
Reasons for Change: Legislation, Settlements, Media
Changes in the policy environment come in the face of increasing public scrutiny evidenced by political action, legislative initiatives, lawsuits, settlements and media coverage.
I. A. Legislation and Regulation:
In the past decade, state and federal oversight of relations between the pharmaceutical industry and physicians has increased dramatically. Heightened concerns around kickback and high costs of healthcare and rise in drug spending are reflected in a series of investigations, inquiries and legislative initiatives in the past decade. The following list represents (not in any chronological order) some prominent events in the politics of regulation physician-industry ties at the federal and the state level:
Changes in the policy environment come in the face of increasing public scrutiny evidenced by political action, legislative initiatives, lawsuits, settlements and media coverage. In the past decade, state and federal oversight of relations between the pharmaceutical industry and physicians has increased dramatically. Heightened concerns around kickback and high costs of healthcare and rise in drug spending are reflected in a series of investigations, inquiries and legislative initiatives in the past decade. The following list represents (not in any chronological order) some prominent events in the politics of regulation physician-industry ties at the federal and the state level:
I. B. Lawsuits and settlements
A series of whistle-blower alerts and class action lawsuits brought against pharmaceutical and device manufacturers in the past decade have resulted in millions of dollars in settlements and greater public awareness of high costs of prescription medication related to industry practices. Some significant lawsuits and settlements are described below. For a more comprehensive listing, see http://www.prescriptionaccess.org/
I. C. Media
The news media and investigative reporting (notably in the New York Times and the Wall Street Journal) have been central to the process of creating public awareness of industry-medicine ties and their effects on patients’ interests, and in moving institutions to change their practices to avoid negative press and publicity.
Common Industry Practices Create Conflicts of Interest
The pharmaceutical industry makes essential products and plays a critical role in the healthcare system. Yet marketing excesses compromise patient care by influencing prescribing and raising healthcare costs. It exerts influence over prescribers through sales representatives, offering gifts, meals, promotional items, medical equipment, free drug samples, financial ties and relationships in the form of funds for CME and conferences, consulting fees, research contracts, stipends and honoraria, research support, and providing product information through ghostwritten articles, treatment guidelines and CME material. The pharmaceutical industry influences consumers primarily through direct to consumer advertising (Angell 2005) http://www.nybooks.com/articles/22237
The Solution: Professionalism in Medicine
A powerful antidote to conflicts of interest in medicine lies in the principle of professionalism. “Professionalism is the basis of medicine's contract with society. It demands placing the interests of patients above those of the physician, setting and maintaining standards of competence and integrity, and providing expert advice to society on matters of health. The principles and responsibilities of medical professionalism must be clearly understood by both the profession and society. Essential to this contract is public trust in physicians, which depends on the integrity of both individual physicians and the whole profession.” (ABIM Foundation)
The primary attributes of professionalism in medicine are altruism and commitment to patients’ interest, self-regulation, maintenance of technical competence and civic engagement.
Challenges to professionalism come in the form of:
a) Financial conflicts of interest
b) HMO / Hospital / Group Practice / Financial Incentive
c) Drug Company Gifts / Travel / Speaker’s Bureau / etc.
d) Weak historical record of self-regulation
e) Pass on troublesome colleagues to the next institution
f) Failure to police activities such as whole body scans and anti-aging clinics and cosmetic claims
g) Making the chart transparent / IT
h) Sharing decision-making data
j) Balancing discretion with protocols
k) The loss of monopoly over technical and valued information
l) The impact of the web
m) The self-directed patient