: 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. (shrink)

A 78 year old married woman with progressive Alzheimer's disease was admitted to a local hospital with pneumonia and other medical problems. She recognized no one and had been incontinent for about a year. Despite aggressive treatment, the pneumonia failed to resolve and it seemed increasingly likely that this admission was to be for terminal care. The patient's husband (who had been taking care of her in their home) began requesting that the doctors be less aggressive in her treatment and, (...) as the days wore on, he became more and more insistent that they scale back their aggressive care. The physicians were reluctant to do so, due to the small but real chance that the patient could survive to discharge. But her husband was her only remaining family, so he was the logical proxy decisionmaker. Multiple conferences ensued, and finally a conference with a social worker revealed that the husband had recently proposed marriage to the couple's housekeeper and she had accepted. (shrink)

Carol Gilligan's In a Different Voice, which appeared in 1982, argued that men tend to conceive morality in terms of rights, justice, and autonomy, whereas women more frequently think in terms of caring, responsibility, and interrelation with others. At about the same time, Nel Noddings in Caring: A Feminine Approach to Ethics and Moral Education sought to articulate and defend in its own right a “feminine” morality centered specifically around the ideal of caring. Since then, there has been a heated (...) debate about the reality of the distinction Gilligan drew and about its potential implications for ethical theory. Discussions of the morality of caring have questioned, in particular, whether any such morality can really provide a total framework for moral thought and action. For in order to deal with our obligations to people we are not acquainted with and address large-scale issues of social morality, any morality of caring seems to require supplementation by typically “masculine” thinking in terms of rights and justice, with the result that caring turns out to be but one part of morality, rather than anything women, or more enlightened men, could find attractive as a total and self-sufficient way of approaching ethical issues. (shrink)

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clinical trials — the “community equipoise” strategy . The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipoise strategy involves the suggestion that our judgment that neither treatment is to be preferred is to (...) be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: medical knowledge is best understood as residing in the community, the judgments of others count as evidence, and so should change one's own opinion, subjects would not be better off outside the trial, and the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs. (shrink)

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized (...) to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry. (shrink)

The physician who upholds the Hippocratic oath is supposed to be loyal to his or her patients. This requires choosing only the therapy that the physician believes is best for the patient. However, knowing what is best requires randomized clinical trials. Thus, clinicians must be willing to recruit their patients to be assigned at random to one of two therapies in order to determine which is best based on the highest standards of pharmacological science.

A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

In his influential 1987 essay, “Equipoise and The Ethics of Randomized Clinical Research,” Benjamin Freedman argued that Charles Fried’s theoretical equipoise requirement threatened clinical research because it was overwhelmingly fragile and rendered unethical too many randomized clinical trials. Freedman, therefore, proposed an alternative requirement, the clinical equipoise requirement, which is now considered to be the fundamental or guiding principle concerning the ethics of enrolling patients in randomized clinical trials. In this essay I argue that Freedman’s clinical equipoise requirement is ambiguous (...) and can be interpreted in (at least) two different ways. I furthermore claim that, ironically, the best interpretation of the clinical equipoise requirement opens Freedman to the same objection that he leveled against Fried twenty-five years ago; namely, that it (Freedman’s clinical equipoise requirement) renders unethical too many randomized clinical trials. (shrink)