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- ↵*Send correspondence to:
Carl J. Pepine, MD, MACC, Professor and Chief, Division of Cardiovascular Medicine, University of Florida College of Medicine, Box 100277, 1600 Archer Road, Gainesville, Florida 32610-0277, USA.
In these complex times, when public opinion is a litmus test of any profession's or organization's image, reputation, and operational methods, it is increasingly clear that the College is in need of guidelines that explicitly define its relationships with commercial, nonprofit, and government organizations and its relationships with individual members and supporters. Such an ethical protocol would serve as a useful road map in support of the values the College holds paramount, an important compass in navigating unfamiliar terrain that may be encountered as the College boldly steps forward with new partners, new programs, and new initiatives on behalf of the cardiovascular specialty. As the leading voice in cardiovascular medicine, both nationally and internationally, the College's role is essential to greater national progress in quality health care. In my view, having an unchallengeable institutional code of ethical conduct is equally essential as the ACC moves toward that goal. The reference list at the end of this article indicates some material related to this discussion and is provided as recommended reading (1–7).
Ethical issues relevant to individuals and professional societies are coming under closer scrutiny. More frequently, the news media report on unethical and illegal business conduct, and not just in Fortune 500 corporate board rooms. These headline stories touch off discussions about ethical standards in all organizations that depend on corporate support and the philanthropy of professional/business leaders. Many leading figures in our professional society question whether the College should engage in any kind of relationship with a business organization that acknowledges involvement in unethical practices or has become the subject of investigation by a federal agency. For example, should the College accept funding for an educational program from a company that's been indicted for fraud? Should it take disciplinary action against a member who provides misleading testimony in a medical liability case? Up until now, these kinds of circumstances have not been considered by the ACC, with the exception of expelling members who are convicted felons.
Responsibility to ethical, law-abiding fellows
The College's conduct and business relationships raise ethical questions about its obligation to its members. Shouldn't the College's conduct reflect values based on the Hippocratic Oath? Isn't the College responsible for protecting its membership from negative exposure of any kind—even from the actions of a single Fellow engaged in unethical or unlawful conduct? And doesn't the College have an obligation to maintain the position and practice of cardiovascular medicine at the very highest ethical plane?
Presently, the organizational will to create a code of ethical conduct is flourishing. Next spring, the ACC and the American Heart Association (AHA) will hold a conference chaired by Dr. Richard Popp, on behalf of the ACC, and Dr. Sidney Smith, on behalf of the AHA. The conference will explore a code that would describe official business relationships where they affect cardiovascular practice and fiscal transactions carried out by staff and volunteer leadership on behalf of either organization. Conference leaders will focus on relationships with industry partners that may be vulnerable to the appearance of conflict of interest, issues of self-referral in patient care, and issues that relate to the independence of investigators doing clinical research with funding from industry sponsors.
In a speech delivered at ACC '03, my immediate predecessor, W. Bruce Fye, MD (3), questioned how clinical trials and guidelines, supported with industry funds, influence the ethics of cardiovascular practice. He noted that conflicts of interest can arise in the industry–academic relationship but must be minimized to ensure the integrity of clinical research—by no means an easy task. According to a health policy report recently published in The New England Journal of Medicine(7), policies at academic and professional institutions vary substantially with regard to procedural safeguards in research, with most policies lacking procedural teeth despite the availability of a model for policy and guidelines that was developed by the Office of Research Integrity at the U.S. Department of Health and Human Services.
The case for peer review
Any ethical code the College adopts should be reflected in the conduct of its members as well. Yet, the ACC has received a number of complaints from members purporting a lack of integrity in their professional peers who testify as expert witnesses in medical liability cases. Some professional societies require members who serve as expert witnesses to submit their testimony for peer review. If a peer review finds testimony to be lacking in factual basis, then the member is sanctioned, given a warning, or even suspended from the respective professional society. Making mediation even more difficult, of course, is the fact that the “standard of care” is not always clear-cut even among expert practitioners.
In an article published in JACCin 2002, Michael S. Lauer, MD, FACC (6), wrote of his experience with non-peer-reviewed testimony in a medical liability lawsuit filed against him. The plaintiff's case revolved around the testimony of one expert witness who had never performed any kind of peer-reviewed research or systematic review of the condition under investigation, myocardial sarcoid. None of the evidence presented against Dr. Lauer was based on randomized trials, high-quality observational studies, or even published practice guidelines; yet, a lay jury was left to ponder its validity. His experience led him to conclude that, at minimum, expert testimony must pass a peer review to increase its credibility before a jury.
The College's Ethics and Discipline Committee is currently exploring the creation of a professional conduct program modeled after one adopted by the American Association of Neurological Surgeons (AANS). The North American Spine Society (NASS) has adopted a similar program. These organizational declarations of acceptable conduct move their respective professional associations to the forefront of medical societies in creating the highest ethical performance standards with regard to patients, the judicial system, and one another. The code adopted by NASS last year outlines acceptable ethical relationships as they pertain to health care providers, patients and their families, and the legal profession. It also outlines the organization's responsibility to government, health care payers, the medical community, and the global spinal care community. Expert witness guidelines are included as well. Clearly, it is a comprehensive code, useful as a model to the ACC.
Defining college ethics
Ethical boundaries between individual physicians and industry must be explicitly defined because, as Dr. Fye reminded us in Chicago, a “blend of altruism and self-interest motivates each individual, institution, and company involved in every phase of health care, whether it's inventing drugs, conducting trials, developing guidelines, educating doctors, or performing procedures.” Our altruism as physicians must be at the foundation of our guiding principles both as an organization and as individual ACC members.
Given the College's reliance on corporate support, as well as support from individuals, the College would be wise to negotiate an ethical contract with itself before a critical point of vulnerability arises. When should it bow out or refuse a partnership? When does the ethical conduct of a single member require action to protect the reputations of the ACC Fellows with whom he/she stands? Without a set of “golden rules,” are we absolutely certain where the College stands, or with whom? An explicit code of ethics—declared, written, and voted into policy—would further enable the ACC to clearly demonstrate its intentions and strengths for the benefit of all who might challenge our integrity, our altruism, or our zeal in pursuing our mission. It would create a new asset with which to identify the College as it enters into new business relationships with a range of new partners and supporters.
I have asked ACC staff and attorneys for their opinions on the appropriate code of ethics for the College and would welcome your opinion as a valued member as well. Please send me your thoughts on this important initiative while it is still being formed.
↵1 President, American College of Cardiology
- American College of Cardiology Foundation
- ↵American College of Cardiology Position Statement: recommended criteria for expert witnesses, ACC board of governors' ad hoc task force to develop recommendations for malpractice reform, Wolf F. C. Duvernoy, MD, FACC, Chair. 1999
- Conti CR. President's page: expert witness testimony. J Am Coll Cardiol 1989;14:1850–1
- Zipes Douglas P.
- Albert Tanya, “Group Aims to Weed Out Deficient Medical Expert Witnesses.” Coalition and Center for Ethical Medical Testimony/CCEMT.org. Aug. 18, 2003
- Lauer M.S.
- ↵Mello MM, Brennan TA. Due process in investigations of research misconduct. N Engl J Med 2003;349:1280–6