Issue 12(2)

Zara J. Bending
The conception of the doctor–patient relationship under Australian law has followed British common law tradition whereby the relationship is founded in a contractual exchange. By contrast, this article presents a rationale and framework for an alternative model—a “Trust Model”—for implementation into law to more accurately reflect the contemporary therapeutic dynamic. The framework has four elements: (i) an assumption that professional conflicts (actual or perceived) with patient safety, motivated by financial or personal interests, should be avoided; (ii) an onus on doctors to disclose these conflicts; (iii) a proposed mechanism to contend with instances where doctors choose not to disclose; and (iv) sanctions for non-compliance with the regime.

A Gentle Ethical Defence of Homeopathy

David Levy, Ben Gadd, Ian Kerridge, and Paul A. Komesaroff
Recent discourses about the legitimacy of homeopathy have focused on its scientific plausibility, mechanism of action, and evidence base. These, frequently, conclude not only that homeopathy is scientifically baseless, but that it is “unethical.” They have also diminished patients’ perspectives, values, and preferences. We contend that these critics confuse epistemic questions with questions of ethics, misconstrue the moral status of homeopaths, and have an impoverished idea of ethics—one that fails to account either for the moral worth of care and of relationships or for the perspectives, values, and preferences of patients. Utilitarian critics, in particular, endeavour to present an objective evaluation—a type of moral calculus—quantifying the utilities and disutilities of homeopathy as a justification for the exclusion of homeopathy from research and health care. But these critiques are built upon a narrow formulation of evidence and care and a diminished episteme that excludes the values and preferences of researchers, homeopaths, and patients engaged in the practice of homeopathy. We suggest that homeopathy is ethical as it fulfils the needs and expectations of many patients; may be practiced safely and prudentially; values care and the virtues of the therapeutic relationship; and provides important benefits for patients.

East–West Differences in Perception of Brain Death

Qing Yang and Geoffrey Miller
The concept of brain death as equivalent to cardiopulmonary death was initially conceived following developments in neuroscience, critical care, and transplant technology. It is now a routine part of medicine in Western countries, including the United States. In contrast, Eastern countries have been reluctant to incorporate brain death into legislation and medical practice. Several countries, most notably China, still lack laws recognizing brain death and national medical standards for making the diagnosis. The perception is that Asians are less likely to approve of brain death or organ transplant from brain dead donors. Cultural and religious traditions have been referenced to explain this apparent difference. In the West, the status of the brain as home to the soul in Enlightenment philosophy, combined with pragmatism and utilitarianism, supports the concept of brain death. In the East, the integration of body with spirit and nature in Buddhist and folk beliefs, along with the Confucian social structure that builds upon interpersonal relationships, argues against brain death. However, it is unclear whether these reasoning strategies are explicitly used when families and medical providers are faced with acknowledging brain death. Their decisions are more likely to involve a prioritization of values and a rationalization of intuitive responses. Why and whether there might be differences between East and West in the acceptance of the brain death concept requires further empirical testing, which would help inform policy-making and facilitate communication between providers and patients from different cultural and ethnic backgrounds.

Why Do People Participate in Epidemiological Research?

Claudia Slegers, Deborah Zion, Deborah Glass, Helen Kelsall, Lin Fritschi, Ngiare Brown, Bebe Loff
Many assumptions are made about public willingness to participate in epidemiological research, yet few empirical studies have been conducted to ascertain whether such assumptions are correct. Our qualitative study of the public and of expert stakeholders leads us to suggest that people are generally prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution such as a government health department, charity, or university. However, there is widespread community distrust of research conducted or sponsored by pharmaceutical companies. Individuals are prompted to take part if the study concerns an illness they or a family member or friend have personally experienced or if they believe the research will confer a widespread public benefit. Preferences vary about the mode of contact for the research to be conducted. Willingness to participate in telephone surveys has decreased in recent years, and this may be a consequence of an increase in calls to homes by telemarketers and market researchers. Participants also stressed the importance of knowing where their names and contact details were sourced and suggested that this information be available to prospective study participants as a matter of course in the first approach or letter. We provide valuable information to epidemiologists in designing studies.

It’s Time: The Case for PrEP as an Active Comparator in HIV Biomedical Prevention Trials

Bridget Haire
In July 2012, based on evidence from two major trials, the United States Food and Drug Administration approved the use of combined oral tenofovir/emtricitabine as pre-exposure prophylaxis (PrEP) for people at high risk of HIV acquisition. PrEP effectiveness is marred by poor adherence, however, even in trial populations, thus it is not a magic bullet for HIV prevention. It is, however, the most effective biomedical HIV prevention intervention available for people at high risk of HIV, particularly those who have receptive sex and lack the power to negotiate condom use. Accordingly, there are compelling reasons to compare future experimental HIV prevention interventions against PrEP. The interests both of trial participants and of science are served by using PrEP as comparator: Not only would HIV incidence be reduced, but also the question of whether new interventions were superior to best proven interventions, in a given setting, would be answered comprehensively.

Off-Label Drug Use as a Consent and Health Regulation Issue in New Zealand

Rebecca Julia Cook
The term “off-label drug use” refers to drugs that have not yet acquired “approved” status or drugs that have acquired “approved” status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996 and the common law, which require that off-label drug use is of an acceptable standard, that the patient should be fully informed, and that the patient should give informed consent. Off-label drug use is an important issue because the current law provides medical practitioners very wide discretionary power, without providing clarification for what is required of the practitioner in exercising his or her discretion in prescribing off-label. This paper discusses possible solutions to this issue, for example, establishing protocol for off-label use, an electronic database of off-label use, and the amendment of legal provisions.

Drug Familiarization and Therapeutic Misconception Via Direct-to-Consumer Information

Jean-Christophe Bélisle-Pipon and Bryn Williams-Jones
Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising (DTCA). However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information (DTCI) campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA.

Health Care Sharing Ministries and Their Exemption From the Individual Mandate of the Affordable Care Act

Charlene Galarneau
The U.S. 2010 Patient Protection and Affordable Care Act (ACA) exempts members of health care sharing ministries (HCSMs) from the individual mandate to have minimum essential insurance coverage. Little is generally known about these religious organizations and even less critical attention has been brought to bear on them and their ACA exemption. Both deserve close scrutiny due to the exemption’s less than clear legislative justification, their potential influence on the ACA’s policy and ethical success, and their salience to current religious liberty debates surrounding the expansion of religious exemptions from ACA responsibilities for both individuals and corporations. Analyzing documents of the United States’ three largest health care sharing ministries and related material, I examine these organizations and their ACA exemption with particular consideration of their ethical dimensions. Here a thick description of the nature and workings of health care sharing ministries precedes a similar account of the ACA exemption. From these empirical analyses, five ethical and policy concerns emerge: (1) the charity versus insurance status of these ministries; (2) the conflation of two ACA religious exemptions; (3) the tension between the values of religious liberty and of justice; (4) the potential undermining of ACA policy goals; and (5) the questionable compliance of health care sharing ministries with ACA exemption requirements. An accurate and informed understanding of HCSMs is required for policymakers and others to justify the ACA exemption of health care sharing ministry members. A sufficient justification would address at least the five ethical and policy concerns raised here.

The Question of Autonomy in Maternal Health in Africa: A Rights-Based Consideration

Jimoh Amzat
Maternal mortality is still very high in Africa, despite progress in control efforts at the global level. One elemental link is the question of autonomy in maternal health, especially at the household level where intrinsic human rights are undermined. A rights-based consideration in bioethics is an approach that holds the centrality of the human person, with a compelling reference to the fundamental human rights of every person. A philosophical and sociological engagement of gender and the notion of autonomy within the household reveals some fundamental rights-based perplexities for bioethical considerations in maternal health. The right to self-determination is undermined, and therefore women’s dignity, freedom and autonomy, capacities, and choices are easily defiled. This study applies a rights-based approach to maternal health and demonstrates how rights concerns are associated with negative outcomes in maternal health in Africa. The discussion is situated at the household level, which is the starting point in health care. The paper submits that beyond legal and political rights within the context of the state, rights-based issues manifest at the household level. Many of those rights issues, especially relating to women’s autonomy, are detrimental to maternal health in Africa. Therefore, a rights-based approach in the social construction of maternal health realities will contribute to alleviating the burden of maternal mortality in Africa.

Mutual Scorn Within the Abortion Debate: Some Parallels With Race Relations

Bertha Alvarez Manninen
By emphasizing the parallels between both racial vilification and the vilification that takes place when we discuss abortion in our society, I hope to provide a new perspective on the way the United States converses about this divisive issue. This perspective, in turn, can help us see how we can move forward from the stagnate polemics that have permeated the abortion debate in the United States for the past 40 years.

Is Premenstrual Dysphoric Disorder Really a Disorder?

Tamara Kayali Browne
Premenstrual dysphoric disorder (PMDD) was recently moved to a full category in the DSM-5 (the latest edition of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders). It also appears set for inclusion as a separate disorder in the ICD-11 (the upcoming edition of the World Health Organization’s International Statistical Classification of Diseases and Related Health Problems). This paper argues that PMDD should not be listed in the DSM or the ICDat all, adding to the call to recognise PMDD as a socially constructed disorder. I first present the argument that PMDD pathologises understandable anger/distress and that to do so is potentially dangerous. I then present evidence that PMDD is a culture-bound phenomenon, not a universal one. I also argue that even if (1) medication produces a desired effect, (2) there are biological correlates with premenstrual anger/distress, (3) such anger/distress seems to occur monthly, and (4) women are more likely than men to be diagnosed with affective disorders, none of these factors substantiates that premenstrual anger/distress is caused by a mental disorder. I argue that to assume they do is to ignore the now accepted role that one’s environment and psychology play in illness development, as well as arguments concerning the social construction of mental illness. In doing so, I do not claim that there are no women who experience premenstrual distress or that their distress is not a lived experience. My point is that such distress can be recognised and considered significant without being pathologised and that it is unethical to describe premenstrual anger/distress as a mental disorder. Further, if the credibility of women’s suffering is subject to doubt without a clinical diagnosis, then the way to address this problem is to change societal attitudes towards women’s suffering, not to label women as mentally ill. The paper concludes with some broader implications for women and society of the change in status of PMDD in the DSM-5 as well as a sketch of critical policy suggestions to address these implications.

Queering Know-How: Clinical Skill Acquisition as Ethical Practice

Cressida J. Heyes and Angela Thachuk
Our study of queer women patients and their primary health care providers (HCPs) in Halifax, Nova Scotia, reveals a gap between providers’ theoretical knowledge of “cultural competency” and patients’ experience. Drawing on Patricia Benner’s Dreyfusian model of skill acquisition in nursing, we suggest that the dissonance between the anti-heteronormative principles expressed in interviews and the relative absence of skilled anti-heteronormative clinical practice can be understood as a failure to grasp the field of practice as a whole. Moving from “knowing-that” to “knowing-how” in terms of anti-heteronormative clinical skills is not only a desirable epistemological trajectory, we argue, but also a way of understanding better and worse ethical practice.

Diagnosis and Treatment for Vulvar Cancer for Indigenous Women From East Arnhem Land, Northern Territory: Bioethical Reflections

Pam McGrath, Nicole Rawson, and Leonora Adidi
This paper explores the bioethical issues associated with the diagnosis and treatment of vulvar cancer for Indigenous women in East Arnhem Land, Northern Territory, Australia. Based on a qualitative study of a vulvar cancer cluster of Indigenous women, the article highlights four main topics of bioethical concern drawn from the findings: informed consent, removal of body parts, pain management, and issues at the interface of Indigenous and Western health care. The article seeks to make a contribution towards Indigenous health and bioethics and bring to light areas of further research.

Case Studies

Culturally Competent Bioethics: Analysis of a Case Study

Ben Gray

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Issue 12(2)

Editorials

“Can a Company be Bitchy?” Corporate (and Political and Scientific) Social Responsibility

In That Case: Necessary Limitation of Medical Treatment, Ageism, or Worse? A Policy Proposal for Limiting Kidney Dialysis Availability Over 75

Letters to the Editor

Bioethical Challenges of the Ebola Outbreak

Between Palliative Care and Euthanasia

Critical Perspectives

Facebook Study: A Little Bit Unethical But Worth It?

Recent Developments

Supporting Innovation in the UK: Care Act 2014

Original Research

Reconceptualising the Doctor–Patient Relationship: Recognising the Role of Trust in Contemporary Health Care