Academic medical centers and conflicts of interest.
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Biomedical subjects
Publications and source records attributed to Howard Brody.
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Shared decision making respects patient autonomy and allows patients to select how much they wish to become involved in various health care decisions. Advance care planning allows a person to document preferences that can become operative at a later time when the person has lost decision-making capacity. Structured methods exist for assessing the presence or absence of decision-making capacity, but some subjectivity cannot be eliminated from these assessments. An ethical challenge in the care of older patients who have diminished capacity is to show respect for their previously expressed wishes and for their present, experienced quality of life.
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Evidence-based medicine (EBM) relies on accurate data derived from well-designed, clinically relevant randomized controlled trials (RCTs). Most randomized trials, however, are conducted by industry sponsors aiming at licensing and marketing drugs, which may weaken the usefulness of the findings to EBM. Disturbing evidence has emerged of widespread biases in industry-sponsored trials, including publication bias, selective reporting of findings, and distorted interpretation of results. These practices compromise the professional integrity of physician-investigators who contribute to them. In turn, the well-being of patients participating in RCTs may be jeopardized, and the evidence base upon which EBM is practiced may be corrupted. Regulatory reform alone will be inadequate to resolve these problems; attention must also be paid to physicians' professionalism. The authors recommend a change in the culture of academic medicine whereby physician-investigators who maintain professional integrity are rewarded or recognized. Educational interventions promoting integrity in clinical research may be one part of affecting such change.
An old joke states that one need not worry about one's enemies, but may be in danger from one's friends. We review a number of "enemies" and "friends" of evidence-based medicine (EBM). To understand where these enemies and friends have come from, it is important to see how the rise of EBM has created shifts in power, especially within academic medicine. Attacks from "enemies"-especially the criticism that EBM amounts to overturning a medicine of the individual in favor of an undesirable population medicine-tend to reflect misunderstandings of EBM, or of the degrees of uncertainty inherent in medicine itself, rather than substantive criticisms. The activities of three categories of so-called friends might well give EBM an undesirable reputation. These "friends" are the practitioners of a crude version of EBM (uncritical acceptance of randomized controlled trials while rejecting all other forms of evidence), commercial sponsors of clinical trials whose biases distort the available evidentiary base, and bureaucrats who employ EBM practices in the service of inequitable rationing of health resources.
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This article describes the variety of approaches used at Michigan State University's College of Human Medicine for teaching ethics, professionalism, and humanities to undergraduate medical students: courses in ethics and health policy; mentoring programs; selectives in history, literature, and spirituality; structured patient care experiences; and discussions with students in their clinical years on the ethical and professional challenges confronting them in their clinical experiences. Some of these approaches, such as the structured patient-care experience, may be unique to Michigan State. The authors place special emphasis on discussing the challenges that confront this curriculum, including struggles to keep up with the pace of change in the health care system, preserving and highlighting the linkages between the "ethics" and the "professionalism" strands of the curriculum, making optimal use of Web technologies, successfully communicating to students the ultimately practical importance of the medical humanities other than ethics, and solving the problems of geography created by a widely dispersed community campus system.
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The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine--specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in a research trial. This overlap is maximal when the same physician occupies both roles with respect to a particular patient-subject. We address the ethical tensions inherent in that role conflict and argue that the tensions are real but manageable. The difference position provides a sound ethical framework within which to manage those tensions, while the similarity position is unsatisfactory because it seeks to deny the existence of the tensions.
The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm.
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Knight has shown how the moral growth of medical students involves a spiritual journey. He may, however, present too sanguine a portrayal of the extent to which the medical education environment promotes this moral and spiritual growth. Medical school may indeed be more abusive than supportive. Admitting more women to medical school and teaching more humanities courses, while worthwhile, will not necessarily promote the goals that Knight appropriately advocates.