Duff Waring

Why the practice of medicine is not a phronetic activity.

This essay argues that the practice ofmedicine is not a phronetic activity in theoriginal Aristotelian sense of that term. Jonsen andToulmin are two philosophers who have conflated thetechne of medicine with phronesis. Thisconflation ignores Aristotles crucial distinctionbetween techne and phronesis and his useof the medical analogy. It is argued that medicalreasoning is similar to phronesis but does notexemplify it. Phronesis will not save thelife of medical ethics. The concept could be utilized as amoral prosthetic.

The Virtuous Patient: Psychotherapy and the Cultivation of Character

The standard approach to ethics in psychotherapy is to focus on the therapist. Although normative “boundary” ethics revolves around what the therapist ought, or ought not, to do, virtue ethics can revolve around the kind of person the therapist ought to be. One can thus apply virtue ethical theory to clinical practice and argue for therapist virtues that are relevant to meeting professional standards and to working effectively through the problems that arise in psychotherapy. Considerably less attention has been paid to how virtue ethics relates to the patient. The ethics of psychotherapy can also revolve around the sort of person the patient should be. I argue that there are (a) nascent virtues which the patient can bring to psychotherapy that, when cultivated with the therapist, can facilitate a beneficial outcome and (b) virtues that can be seen as psychotherapeutic goals toward which the patient ought to strive.

The physician/investigator's obligation to patients participating in research: the case of placebo controlled trials.

ome authors argue that the ethics of medical care and the ethics of research differ, and that it S is a mistake to conflate the two.’ They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.”2 This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the physicianpatient relationship. Miller and Brody suggest that medical training is to blame for what they believe is the physicians’ tendency to confound the obligations of research and practice. “Physician-investigators, after all, went to medical school” they explain. They believe that considering research with patients outside the ethical framework of the physician-patient relationship may be “difficult and threatening” to physicians who have “psychological needs” to consider the ethical obligations flowing from their relationship with their patients. They appear to suggest that if physicians went to “investigator’s school” instead of medical school, they would not have such “psychological needs.”3 The authors criticize what they call the “mainstream ethical approach” to clinical trials under which physicians retain the therapeutic obligations of beneficence and non-maleficence governing the clinical practice of medicine. Their ethical basis for distinguishing research from clinical care is that the two enterprises have different objectives. The former is designed to answer a research question, while the latter is intended to provide care in the patient’s interest. The result is a claim that the ethics of the traditional physician/patient relationship do not apply to research because a clinical trial is not “a form of therapy.” Consequently, they allege, the investigator’s obligation is only one of not exploiting research participants by exposing them to excessive risk, as opposed to acting in their best interests.* The discussion of a physician investigator’s obligations is important in the context of placebo controlled trials, where the choice of treatments for control patients has been recognized as both a methodological and an ethical issue. Some have argued that placebo and not active controls are required methodologically in order to demonstrate whether an unproven treatment is effective, even when an established effective intervention, or standard therapy, is available.5 We take issue with this contention, and have written to this effect elsewhere.6 Many, ourselves included, have written about the ethics of using placebo controls in clinical trials and the issues have been well laid 0ut.7 However, little consideration has been given to important legal questions arising out of such trials. In particular, questions of potential legal liability for harm to a research participant occasioned by withholding available treatment in the placebo arm of a trial have received little attention beyond our own work.8 One response to this apparent lack of interest may be that there have not been any legal judgments involving harm from participation in a placebo con-

Integrating Values in Risk Analysis of Biomedical Research: The Case for Regulatory and Law Reform

This paper offers a critical appraisal of the regulatory approach towards risk assessments of new biomedical technologies, with a particular emphasis on gene transfer and stem cell research. While the therapeutic and commercial potential of this research is well publicized, the normative and methodological problems pertaining to the assessment of its potential risks to research participants have received less attention. We build on previous analyses of risk assessment as a value-laden, political exercise in regulatory science. Parties to a risk debate can bring different value-frameworks to the process of biomedical research review. We see the potential for a conflict of interest if risk assessments are formulated exclusively by the parties who propose the research, which is currently often the case. They might be more prone to taking risks for the sake of possible benefits and much less risk cautious than the research participants who assume the risks. We argue for a review process which aims to balance the interests of those proposing risk by providing a mandate for the critical interests of those who might assume it. In the paper, we classify two general types of risk that have been highlighted by gene transfer and stem cell research: risks to persons and risks to social values. We then consider three risks which we believe the law should address. These are risks of physical or psychological harm to participants, risks to the objectivity and scientific integrity of research that are posed by conflicts of interest; and briefly, risks to other social values, e.g., public trust in the ethical conduct of research. These are very different areas of risk, but we argue that there is merit in addressing them jointly. In areas where there are problems with the understanding and transmission of risk information to subjects, there is greater concern about impact of conflicts of interest and more reason to develop a fully independent review of risks. We sketch some principles and guidelines for institutional reforms that could inspire the further development of a regulatory or legislative model for the oversight of research with human participants.

Paradoxical Drug Response and the Placebo Effect: A Discussion of Grunbaum's Definitional Scheme

Grunbaum claims that the remedial failure of atreatments characteristic factors is thegeneric, objective property of a placebo. Hestipulates that a treatment is placebic if thisremedial failure exacerbates the targetdisorder. This stipulation can subsume asplacebic effects that might be solelypharmacological, e.g., paradoxical reactions tocertain psychiatric drugs. If that exacerbationcan be explained pharmacologically, then wemight question whether Grunbaums definitionalscheme captures the core identity of what weusually intend by the placebo concept. Ipropose that this core identity is bestcaptured by a symbolic meaning hypothesis inwhich psychological factors exert thedeterminative influence.