Applying evidence to support ethical decisions: Is the placebo really powerless?

Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and “knowledge framing”. While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing — which is only conceptually different from placebo — is a desired, expected and necessary component of any doctor-patient encounter. Examples from daily practice demonstrate both, the need to investigate the effects of knowledge framing and its impact on ethical, medical, economical and legal decisions. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Parental refusals of medical treatment: the harm principle as threshold for state intervention

Minors are generally considered incompetent to provide legally binding decisions regarding their health care, and parents or guardians are empowered to make those decisions on their behalf. Parental authority is not absolute, however, and when a parent acts contrary to the best interests of a child, the state may intervene. The best interests standard is the threshold most frequently employed in challenging a parent's refusal to provide consent for a child's medical care. In this paper, I will argue that the best interest standard provides insufficient guidance for decision-making regarding children and does not reflect the actual standard used by medical providers and courts. Rather, I will suggest that the Harm Principle provides a more appropriate threshold for state intervention than the Best Interest standard. Finally, I will suggest a series of criteria that can be used in deciding whether the state should intervene in a parent's decision to refuse medical care on behalf of a child.     

Do self‐presentation concerns moderate the relationship between implicit and explicit homonegativity measures?

This study investigated whether the relation between implicit and explicit homonegativity measures is affected by self-presentation concerns, since previous research in this area has been inconclusive. In Experiment 1, 70 high-school students made evaluative ratings of pictures of homosexual and heterosexual couples. Self-presentation was manipulated by either instructing participants that the study concerned attitudes regarding sexual orientation (socially sensitive) or attitudes regarding age (less sensitive). The age-instruction led to increased homonegativity but not to a stronger correlation with an Implicit Association Test (IAT; Greenwald, McGhee & Schwartz, 1998) with homo/heterosexual couples. Concerns regarding the construct validity of the present implementation of the IAT were alleviated in Experiment 2, where heterosexual (n= 30) but not homosexual (n= 30) participants showed implicit homonegativity. The current findings are problematic for the interpretation of low correspondence between implicit and explicit attitude measures as being primarily an effect of self-presentation concerns.     

Defining and Delineating a Duty to Prognosticate

Prognostication, the process offormulating and communicating a prognosis, isno longer considered by most physicians to bean essential task in caring for patients withserious illness. Because of this fact, it isnot surprising to find that when physiciansattempt to engage in prognostication, they doit poorly. What may be surprising to thoseoutside the medical community is the extent towhich professional norms have developed whichactively discourage physicians from engaging inprognostication. This article explores thecauses of this state of affairs and thejustifications offered for it. The conclusionis reached that physicians have a professionalresponsibility to competently engage inprognostication based upon the doctrine ofinformed consent, and that a failure or refusalto do so has not only potential legalramifications, but serious negativeimplications for many of the core issues inbioethics, such as the use of advancedirectives, palliative medicine, and medicalfutility.     

Age as a modifier of sexually aggressive attitudes in men

Male attitudes and behaviours related to imagined sexual aggression were investigated in 99 Finnish men (mean age 24.3 years). Structural equation modelling suggested that imagined sexual aggression was directly predicted by hostile masculine ideologies and past antisocial acts, and indirectly by subject age (hostile masculinity decreased with age). For more detailed analyses of age effects on attitudes, the subjects were split into an older and a younger group. A small group of incarcerated rapists (n = 8; mean age 33.4 years) was included for comparative purposes; these were similar in age to the older group (n = 34; mean age 31.5 years) and were given the same attitude items. The younger men and the rapists expressed significantly more hostility toward women and acceptance of rape myths, and had a higher likelihood of committing rape than older men. Although younger men accepted interpersonal violence and sexual dominance, their attitudes were not necessarily reflected in past sexually aggressive behaviours, as they were in the rapists who differed from the younger men mainly in terms of their past antisocial activities.     

Women's knowledge of prenatal ultrasound and informed choice

This study evaluated women's understanding of prenatal ultrasound in terms of meeting the requirements for informed choice. A cross-sectional survey was conducted to evaluate (1) how information is provided, (2) women's perceived value of the information received and, (3) their understanding of ultrasound in relation to the principles of informed choice. Women (n = 113) completed a questionnaire prior to their 18-week ultrasound. Fifty-five percent stated they received no information from their care provider. Only 31.9% considered health care providers as a very helpful source of information. Yet, 69.0% stated their care provider gave them information that facilitated their understanding. Gaps were identified in women's understanding of ultrasound. Specifically, 46.0% did not view ultrasound as a screen for anomalies; some were uncertain about the safety (18.6%), diagnostic capabilities (26.5%), and limitations of testing (37.2%). These results suggest that women's understanding of ultrasound does not meet the requirements of informed choice.     

Who owns the data in a clinical trial?

Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my opinion, data from both publicly and privately funded research should be made available, in a format that protects confidentiality and intellectual property rights, to interested and responsible parties within a reasonable period of time after publication. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. J. M. Drazen is Editor-in-Chief of The New England Journal of Medicine and Professor of Medicine at Harvard Medical School.     

Should we presume moral turpitude in our children? – Small children and consent to medical research

When children are too young to make their ownautonomous decisions, decisions have to be madefor them. In certain contexts we allow parentsand others to make these decisions, and do notinterfere unless the decision clearly violatesthe best interest of the child. In othercontexts we put a priori limits on whatkind of decisions parents can make, and/or whatkinds of considerations they have to take intoaccount. Consent to medical research currentlyfalls into the second group mentioned here. Wewant to consider and ultimately reject one ofthe arguments put forward for putting medicalresearch into the second category. We willargue that some objections to children'sparticipation in research are either based onan implausibly restrictive conception of whatis in fact in the child's best interests orthat there is an implicit and false premisehidden in this argument; i.e., the premise thatour children have so deeply fallen into moralturpitude that we must assume that they wouldnot want to fulfill their moral obligations,or, that they will grow up to be morallydeficient and will then wish not to have actedwell while a child.     

Rawls and Research on Cognitively Impaired Patients: A Reply to Maio

In his paper, “The Relevance of Rawls’ Principle of Justice for Research on Cognitively Impaired Patients” (Theoretical Medicine and Bioethics 23 (2002):45–53), Giovanni Maio has developed athought-provoking argument for the permissibility of non-therapeutic research on cognitively impaired patients. Maio argues that his conclusion follows from the acceptance of John Rawls’s principles of justice, specifically, Rawls’s “liberty principle” Maio has misinterpreted Rawls’s “libertyprinciple” – correctly interpreted it does notsupport non-therapeutic research on cognitivelyimpaired patients. Three other ‘Rawlsian’ arguments are suggested by Maio’s discussion –two “self-respect” arguments and a “presumed consent” argument – but none of them are convincing. However, an alternative argument developed from Rawls’s discussion of “justice in health care” in his most recent book, Justice as Fairness: A Restatement, may justify certain kinds of non-therapeutic research on some cognitively impaired patients in special circumstances. We should not expect anything more permissive from a liberal theory of justice. This revised version was published online in June 2006 with corrections to the Cover Date.