Physician health and wellness.

BACKGROUND: Impaired physician health can have a direct impact on patient health care and safety. In the past, problems of alcoholism and substance abuse among physicians have received more attention than other conditions-usually in the form of discipline. While patient safety is paramount, the medical profession may be more successful in achieving the required standards by fostering a culture committed to health and wellness as well as supporting impaired physicians. OBJECTIVE: To develop ethical guidelines regarding physician health and wellness. METHODS: The American Medical Association's (AMA's) Council on Ethical and Judicial Affairs developed recommendations based on the AMA's Code of Medical Ethics, an analysis of relevant Medline-indexed articles, and comments from experts. The report's recommendations were adopted as policy of the Association in December 2003. RESULTS: Individually, physicians can promote their personal health and wellness through healthy living habits, including having a personal physician. The medical profession can foster health and wellness if its members are taught to identify colleagues in need of assistance and initiate appropriate methods of intervention, including referrals to physician health programs. CONCLUSIONS: Physicians whose health or wellness is compromised should seek appropriate help and engage in honest self-assessment of their ability to practice. The medical profession should provide an environment that helps to maintain and restore health and wellness. Physicians need to ensure that impaired colleagues promptly modify or cease practice until they can resume professional patient care. In addition, physicians may be required to report impaired colleagues who continue to practice despite reasonable offers of assistance.

Managing conflicts of interest in the conduct of clinical trials.

The interaction between medical research and for-profit corporations is not new, but it has expanded considerably in recent years. Some of the recent trends may accelerate the research process, particularly when large clinical trials are required. However, a renewed commitment to the application of high ethical standards is essential to ensure that societal trust in research is not eroded, subjects enrolled in trials do not become merely a means to an end, and medical research is efficiently translated into clinical advances that will benefit future patients. This article focuses on the analysis of conflicts of interest in the conduct of clinical trials in both academic and community-based settings. Specifically, it discusses how the roles of research scientists and clinical practitioners differ and the importance of ensuring that participants' consent to enroll in clinical trials is not the result of confusion about the goals of an experimental treatment that may resemble clinical care. The article also discusses the potential conflicts of interest that can arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials and examines various instances in which disclosure of information regarding funding and compensation may serve to minimize such conflicts. This article emphasizes that to preserve the integrity of research and to protect the welfare of human subjects who enroll in trials, physicians should have adequate training in the conduct of research and be familiar with the ethics of research. When a physician has treated or continues to treat a patient who is eligible to enroll as a subject in a clinical trial conducted by the same physician, someone other than the treating physician should obtain the participant's informed consent. Finally, the article addresses disclosure of financial incentives and related funding issues.

Surgical "placebo" controls.

OBJECTIVE: To set ethical guidelines on the use of surgical placebo controls in the design of surgical trials. BACKGROUND DATA: Ethical concerns recently arose from surgical trials where subjects in the control arm underwent surgical procedures that had the appearance of a therapeutic intervention, but during which the essential therapeutic maneuver was omitted. Although there are ethical guidelines on the use of a placebo in drug trials, little attention has been paid to the use of a surgical placebo control in surgical trials. METHODS: The Council on Ethical and Judicial Affairs developed ethical guidelines based on a wide literature search and consultation with experts. RESULTS: Surgical placebo controls should be limited to studies of new surgical procedures aimed at treating diseases that are not amenable to other surgical therapies, and are reasonably anticipated to be susceptible to substantial placebo effects. If the standard nonsurgical treatment is efficacious and acceptable to the patient, then it must be offered as part of the study design. CONCLUSIONS: Surgical placebo controls should be used only when no other trial design will yield the requisite data and should always be accompanied by a rigorous informed consent process and a careful consideration of the related risks and benefits. The recommended ethical guidelines were adopted as AMA ethics policy and are now incorporated in the AMA's Code of Medical Ethics.