Robert M. Tenery

Surgical “placebo” Controls

ObjectiveTo set ethical guidelines on the use of surgical placebo controls in the design of surgical trials. Background DataEthical 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. MethodsThe Council on Ethical and Judicial Affairs developed ethical guidelines based on a wide literature search and consultation with experts. ResultsSurgical 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. ConclusionsSurgical 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.

Optimal use of orders not to intervene and advance directives

More rigorous efforts in advance care planning are required in order to tailor end-of-life care to the preferences of patients so that they can experience a satisfactory last chapter of their lives. There is need for better availability and tracking of advance directives, and more uniform adoption of form documents that can be honored in every state. The discouraging evidence of inadequate end-of-life decision making indicates the necessity of several improvement strategies. In response to this need, the Council on Ethical and Judicial Affairs of the American Medical Association has examined this issue again and presents the following report and recommendations.

Medical Ethics: Medical Etiquette

The rules of conduct which have been considered to be in the domain of medical etiquette or manners will also open the way for the mutual understanding, the sharing of knowledge, and the fellowship which are traditional with our profession. The physician who does not enjoy the good will of his colleagues can expect to have a lonesome, unhappy professional life and would do well to inspect his manners. Medical etiquette is almost unknown to many younger physicians because the suggested guidelines for this facet of professional conduct were not labeled as such when the Principles of Medical Ethics was revised in 1957. The Judicial Council has stated that “the 1957 edition of the Principles was not intended to and does not abrogate any ethical principle expressed in the 1955 edition.” The 1957 edition of the Principles succinctly expresses the fundamental ethical concepts embodied in the cumbersome earlier document that had served for 110 years. The essence of every basic principle is preserved. Following sections 1, 4, 5, and 8 of the Principles as published in the Judicial Council Opinions and Reports, 1965, are the opinions relating to medical etiquette. Honorable men need no laws. They inherently know what is right or wrong and are naturally considerate of the feelings of their patients and their colleagues. Some physicians seem to have difficulty in applying the Principles to specific problems, however. Through my work with county and state medical societies, I have discovered a formula that usually works fairly well, even for those who do not know the Principles. This formula consists of three measuring rods which can be applied to any problem of ethics. First, the measure of intent: One should determine if the intent of an act or a practice is to benefit the patient, the public, the profession, or the physician. Naturally, the primary intent must be the benefit of the patient. If it is for the physician’s own benefit, then there is a good chance that the practice is unethical. Second, the measure of local custom and laws: The opinions of the Judicial Council have necessarily left the question of the ethical acceptability of many practices for local determination because of the multiplicity of variations from state to state and even from county to county. Local custom and community ideals should be taken into consideration when applying the ethical precepts to particular fact situations. Third, the measure of the golden rule: This can be applied to the rules of medical etiquette and to our relationships with patients and their families. The physician always can ask himself what treatment he would expect were the positions reversed. Principles do not change. Interpretation and mode of application of principles may vary as the social environment changes, but the basic principles remain the same. For example, the rules concerning consultations were written before the days of modern specialization and are not altogether practical today, but the general principles still hold true. Basically, the general principles decree that consultations are to be conducted in the best interests of the patient, that the physicians involved are to be considerate of each other, and that the position of the family physician is to be respected. Section 8 of the principles states that “A physician should seek consultation upon request; in doubtful or difficult cases; or whenever it appears that the quality of medical service may be enhanced thereby.” The doctor who does not welcome the opportunity to have the opinion of a colleague must be completely egocentric or insecure. Problems between physicians resulting from patient referrals usually stem from inadequate or faulty communication. When a patient is referred to a consultant, the referring physician should give the consultant a summary, including a report of the case history, pertinent physical and laboratory findings, the past course of treatment, his professional opinion, information relating to any psychic overlay of personality difficulties that might affect the course of treatment, a brief recital of the information given to the patient and his family, some indication of the patient’s financial circumstances, and an expression of whether an opinion or both an opinion and continuing treatment are desired.... I believe that probably one of the most common mistakes made by young physicians is criticism of the methods of older physicians. No amount of scientific apparatus can replace the judgment and intuition that comes from years of experience in caring for the sick. Some day, if we are fortunate, we all become “older physicians.”...