Franklin G. Miller

Screening and cognitive impairment: Ethics of forgoing mammography in older women

Mammographic screening for breast cancer in cognitively impaired women poses significant ethical questions. Many woman with dementia should not be screened because of the greater harm than benefits and the difficulty in obtaining informed consent. This article reviews the current controversy about mammography and then suggests a risk/benefit analysis for this vulnerable population. Autonomy, decision‐making capacity, and the roles of surrogates and physicians are considered, as are ageism and the risk of undertreatment. The harm of overdiagnosis and subsequent overtreatment for women who are cognitively impaired, have comorbidity and a limited life span are outlined. In these cases, the burdens of mammography outweigh the benefits. For women with early cognitive impairment and longer life expectancies, the potential benefits may outweigh the harms. A decision‐making process by the patient, proxy, and practitioner that takes account of foreseeable risks and benefits, patient capacity and preferences, and the effect of this screening intervention on quality of life is outlined.

Enrolling Decisionally Incapacitated Subjects in Neuropsychiatric Research

This paper discusses the National Bioethics Advisory Commissions (NBACs) report on research involving persons with mental disorders that may affect decisionmaking capacity. After placing the NBAC recommendations into their historic context, the authors propose a strategy to enroll decisionally incapacitated subjects into neuropsychiatric research. The authors maintained that their proposed consensus model for research authorization, utilizing subject advocates, fosters valuable clinical research while protecting potentially vulnerable subjects.

Effects of placebos without deception compared with no treatment: a systematic review and meta-analysis

To investigate the clinical efficacy of open‐label placebos compared with no treatment in a systematic review and meta‐analysis.

Vasopressin Boosts Placebo Analgesic Effects in Women: A Randomized Trial.

BACKGROUND Social cues and interpersonal interactions strongly contribute to evoke placebo effects that are pervasive in medicine and depend upon the activation of endogenous modulatory systems. Here, we explore the possibility to boost placebo effects by targeting pharmacologically the vasopressin system, characterized by a sexually dimorphic response and involved in the regulation of human and nonhuman social behaviors. METHODS We enrolled 109 healthy participants and studied the effects of intranasal administration of an arginine vasopressin 1A and 1B receptor agonist against 1) no treatment, 2) oxytocin, and 3) saline in a randomized, placebo-controlled, double-blind, parallel design trial using a well-established model of placebo analgesia while controlling for sex differences. RESULTS Vasopressin agonists boosted placebo effects in women but had no effect in men. The effects of vasopressin on expectancy-induced analgesia were significantly larger than those observed in the no-treatment (p < .004), oxytocin (p < .001), and saline (p < .015) groups. Moreover, women with lower dispositional anxiety and cortisol levels showed the largest vasopressin-induced modulation of placebo effects, suggesting a moderating interplay between pre-existing psychological factors and treatment cortisol changes. CONCLUSIONS This is the first study that demonstrates that arginine vasopressin boosts placebo effects and that the effect of vasopressin depends upon a significant sex by treatment interaction. These findings are novel and might open up new avenues for clinically relevant research due to the therapeutic potentials of vasopressin as well as the possibility to systematically control for influences of placebo responses in clinical trials.

Ethical complexities in standard of care randomized trials: A case study of morning versus nighttime dosing of blood pressure drugs.

Background: Pragmatic trials comparing “standard of care” treatments provide comparative effectiveness data to make practice of medicine more evidence-based. With electronic health records, recruiting and conducting such trials can be relatively inexpensive. But some worry that the traditional research ethics framework poses unnecessary obstacles and is not appropriate for evaluating such clinical trials. This concern is based on the view (which we call the “Standard of Care Principle”) that such research is similar to usual clinical practice and therefore does not raise significant ethical issues since everyone in the research study will receive an accepted standard of care treatment. Methods: A case study of a pragmatic randomized clinical trial (Blood Pressure Medication Timing study) comparing morning versus nighttime dosing of antihypertensive medications. The Blood Pressure Medication Timing study has been proposed as a paradigm example of why the Standard of Care Principle obviates the need for traditional levels of ethical scrutiny and how the current regulatory framework poses unnecessary obstacles to research. We provide an ethical analysis of the Blood Pressure Medication Timing study, drawing on the empirical literature as well as on normative analysis. Results: The Standard of Care Principle is the main ethical rationale given by commentators for asserting that the Blood Pressure Medication Timing study does not require “significant ethical debate” and by investigators for the assertion that the Blood Pressure Medication Timing study is minimal risk and thus eligible for lessened regulatory requirements. However, the Blood Pressure Medication Timing study raises important ethical issues, including whether it is even necessary, given the considerable randomized clinical trial evidence in support of nighttime dosing, a much larger (N ≈ 17,000) confirmatory randomized clinical trial already in progress, evidence for safety of nighttime dosing, and the cost-free availability of the intervention. Furthermore, the Standard of Care Principle provides a misleading basis for analyzing the informed consent requirements, especially regarding the requirement to disclose alternative courses of treatment that “might be advantageous to the subject.” Conclusion: The Standard of Care Principle is ethically inadequate and misleading even when it is applied to the pragmatic randomized clinical trial proposed as a paradigm case for its application.

Do the ‘brain dead’ merely appear to be alive?

The established view regarding ‘brain death’ in medicine and medical ethics is that patients determined to be dead by neurological criteria are dead in terms of a biological conception of death, not a philosophical conception of personhood, a social construction or a legal fiction. Although such individuals show apparent signs of being alive, in reality they are (biologically) dead, though this reality is masked by the intervention of medical technology. In this article, we argue that an appeal to the distinction between appearance and reality fails in defending the view that the ‘brain dead’ are dead. Specifically, this view relies on an inaccurate and overly simplistic account of the role of medical technology in the physiology of a ‘brain dead’ patient. We conclude by offering an explanation of why the conventional view on ‘brain death’, though mistaken, continues to be endorsed in light of its connection to organ transplantation and the dead donor rule.

Is heart transplantation after circulatory death compatible with the dead donor rule

Dalle Ave et al (2016) provide a valuable overview of several protocols for heart transplantation after circulatory death. However, their analysis of the compatibility of heart donation after circulatory death (DCD) with the dead donor rule (DDR) is flawed. Their permanence-based criteria for death, which depart substantially from established law and bioethics, are ad hoc and unfounded. Furthermore, their analysis is self-defeating, because it undercuts the central motivation for DDR as both a legal and a moral constraint, rendering the DDR vacuous and trivial. Rather than devise new and ad hoc criteria for death for the purpose of rendering DCD nominally consistent with DDR, we contend that the best approach is to explicitly abandon DDR.

Is the concept of clinical equipoise still relevant to research

Spencer Hey, Alex John London, and Charles Weijer argue that there is no better framework for justifying patient participation in research. But Annette Rid and Franklin Miller say that it is a mistake to require clinical research ethics to align with the norms of clinical practice

The ethics of placebo treatments in clinical practice: a reply to Glackin

In ‘Placebo treatments, informed consent, and “the grip of a false picture”’ Shane Nicholas Glackin argues that if a physician offers a patient an inert placebo with the following disclosure, this is compatible with informed consent and is not deceptive: ‘I would like to offer you a pill which I believe can help lessen your suffering. I do not know exactly how it works. I have other pills to offer whose mechanism is clearer, but I am not sure that they will work better for you, and they may also entail more serious side effects’. According to Glackin, telling patients that the recommended treatment is an inert placebo is providing incidental information, analogous to telling a patient the chemical details of an active drug. He argues that this information would influence a patients decision only if she was ‘in the grip of a false picture’ that inert drugs do not have physical effects on patients’ bodies. We contend that this disclosure typically is incompatible with informed consent and typically is deceptive. We give an example of a transparent placebo disclosure, that is, a disclosure that is compatible with informed consent and is not deceptive.

Advice and care for patients who die by voluntarily stopping eating and drinking is not assisted suicide

BackgroundA competent patient has the right to refuse foods and fluids even if the patient will die. The exercise of this right, known as voluntarily stopping eating and drinking (VSED), is sometimes proposed as an alternative to physician assisted suicide. However, there is ethical and legal uncertainty about physician involvement in VSED. Are physicians advising of this option, or making patients comfortable while they undertake VSED, assisting suicide? This paper attempts to resolve this ethical and legal uncertainty.DiscussionThe standard approach to resolving this conundrum has been to determine whether VSED itself is suicide. Those who claim that VSED is suicide invariably claim that physician involvement in VSED amounts to assisting suicide. Those who claim that VSED is not suicide claim that physician involvement in VSED does not amount to assisting suicide. We reject this standard approach.ConclusionWe instead argue that, even if VSED is classified as a kind of suicide, physician involvement in VSED is not a form of assisted suicide. Physician involvement in VSED does not therefore fall within legal provisions that prohibit VSED.