A Costly Separation Between Withdrawing and Withholding Treatment in Intensive Care

Ethical analyses, professional guidelines and legal decisions support the equivalence thesis for life‐sustaining treatment: if it is ethical to withhold treatment, it would be ethical to withdraw the same treatment. In this paper we explore reasons why the majority of medical professionals disagree with the conclusions of ethical analysis. Resource allocation is considered by clinicians to be a legitimate reason to withhold but not to withdraw intensive care treatment. We analyse five arguments in favour of non‐equivalence, and find only relatively weak reasons to restrict rationing to withholding treatment. On the contrary, resource allocation provides a strong argument in favour of equivalence: non‐equivalence causes preventable death in critically ill patients. We outline two proposals for increasing equivalence in practice: (1) reduction of the mortality threshold for treatment withdrawal, (2) time‐limited trials of intensive care. These strategies would help to move practice towards more rational treatment limitation decisions.     

Research versus practice: The dilemmas of research ethics in the era of learning health‐care systems

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels.     

公立医院药事服务费收取标准的测算与敏感性分析

通过文献综述对药事服务费的相关概念进行了梳理。在此基础上,利用上海市宝山区5家综合性医院的财务会计报表和调查统计表数据,分别测算了弥补药品加成收入和弥补药事服务成本两种不同思路下的药事服务费,并对不同财政投入和医疗服务价格政策下的药事服务费收取标准进行了敏感性分析,为政府科学决策提供了理论依据。研究认为,取消药品加成、收取药事服务费是医改深入推进的必然趋势,药事服务费在不同经济发展程度的地区可有不同收费标准,但均要建立定期调整机制。     

Observations on ethical problems and terminal care.

Progress in medical diagnosis and therapy has raised new problems with far-reaching ethical implications. Medicine must remain a profession and not become a business. Textbooks must address ethical problems in the context of health care decisions and not restrict themselves to pathophysiology and practical therapeutics alone. The relative roles of the principles of autonomy, non-maleficence, beneficence, and justice must be balanced and appropriately applied to individual situations in biomedical ethics. When therapy becomes futile and the suffering of the patient does not justify any anticipated benefit, the patient (and/or patient surrogate) may request withholding or even withdrawing life-prolonging interventions. In the persistent vegetative state, even nutritional support by an unnatural (tube) route may ethically be denied at the patient's (or surrogate's) informed decision. New areas of ethical evaluation have been raised by the desire of some individuals to prolongation of their lives at high expense to the society such that other individuals are denied services because of limitation of available resources. There has been a long-standing conflict of interest between the acceptance by physicians and/or medical institutions of money or gifts from pharmaceutical companies whose drugs they prescribe, stock, or sell. This practice increases the cost of the drugs and is, in effect, a "sick tax," which is morally wrong.     

Equity Under the Knife: Justice and Evidence in Surgery

Surgery is an increasingly common and expensive mode of medical intervention. The ethical dimensions of the surgeon‐patient relationship, including respect for personal autonomy and informed consent, are much discussed; but broader equity issues have not received the same attention. This paper extends the understanding of surgical ethics by considering the nature of evidence in surgery and its relationship to a just provision of healthcare for individuals and their populations.     

A ROBUST,PARTICULARIST ETHICAL ASSESSMENT OF MEDICAL TOURISM

Recently, in increasing numbers, citizens of wealthy nations are heading to poorer countries for medical care. They are traveling to the global South as medical tourists because in their home nations either they cannot get timely medical care or they cannot afford needed treatments. This essay offers a robust, particularist ethical assessment of the practice of citizens of richer nations traveling to poorer countries for healthcare.     

[Re]considering Respect for Persons in a Globalizing World

Contemporary clinical ethics was founded on principlism, and the four principles: respect for autonomy, nonmaleficence, beneficence and justice, remain dominant in medical ethics discourse and practice. These principles are held to be expansive enough to provide the basis for the ethical practice of medicine across cultures. Although principlism remains subject to critique and revision, the four‐principle model continues to be taught and applied across the world. As the practice of medicine globalizes, it remains critical to examine the extent to which both the four‐principle framework, and individual principles among the four, suffice patients and practitioners in different social and cultural contexts. Using the four‐principle model we analyze two accounts of surrogate decision making – one from the developed and one from the developing world – in which the clinician undertakes medical decision‐making with apparently little input from the patient and/or family. The purpose of this analysis is to highlight challenges in assessing ethical behaviour according to the principlist model. We next describe cultural expectations and mores that inform both patient and clinician behaviors in these scenarios in order to argue that the principle of respect for persons informed by culture‐specific ideas of personhood may offer an improved ethical construct for analyzing and guiding medical practice in a globalized and plural world.     

Ethical Implications of Case‐Based Payment in China: A Systematic Analysis

How health care providers are paid affects how medicine is practiced. It is thus important to assess provider payment models not only from the economic perspective but also from the ethical perspective. China recently started to reform the provider payment model in the health care system from fee‐for‐service to case‐based payment. This paper aims to examine this transition from an ethical perspective. We collected empirical studies on the impact of case‐based payment in the Chinese health care system and applied a systematic ethical matrix that integrates clinical ethics and public health ethics to analyze the empirical findings. We identified eleven prominent ethical issues related to case‐based payment. Some ethical problems of case‐based payment in China are comparable to ethical problems of managed care and diagnosis related groups in high‐income countries. However, in this paper we discuss in greater detail four specific ethical issues in the Chinese context: professionalism, the patient‐physician relationship, access to care and patient autonomy. Based on the analysis, we cautiously infer that case‐based payment is currently more ethically acceptable than fee‐for‐service in the context of China, mainly because it seems to lower financial barriers to access care. Nonetheless, it will be difficult to justify the implementation of case‐based payment if no additional measures are taken to monitor and minimize its existing negative ethical implications.     

THE PLACE AND TRAINING OF THE GENERAL PRACTITIONER

Training for the medical student whose goal is general practice should aim at equipping him to maintain the close personal relationship with the patient which is considered the ideal basis for the treatment and prevention of disease. Preparation for general practice should anticipate graduate experience on a par with that which is currently considered necessary for the various specialties. Internship should be such as to fit the general practitioner to the peculiarities of the kind of community in which he will practice. Ability to recognize his own limitations and situations in which special consultation or referral are indicated should be developed in the student.The University of Colorado School of Medicine has adopted a course of training, from pre-medical education through internship, designed for the student who is to specialize in general practice.     

Islamic medical ethics: a primer

Modern medical practice is becoming increasingly pluralistic and diverse. Hence, cultural competency and awareness are given more focus in physician training seminars and within medical school curricula. A renewed interest in describing the varied ethical constructs of specific populations has taken place within medical literature. This paper aims to provide an overview of Islamic Medical Ethics. Beginning with a definition of Islamic Medical Ethics, the reader will be introduced to the scope of Islamic Medical Ethics literature, from that aimed at developing moral character to writings grounded in Islamic law. In the latter form, there is an attempt to derive an Islamic perspective on bioethical issues such as abortion, gender relations within the patient-doctor relationship, end-of-life care and euthanasia. It is hoped that the insights gained will aid both clinicians and ethicists to better understand the Islamic paradigm of medical ethics and thereby positively affect patient care.     

Professional societies and industry support: what is the quid pro quo?

Professional medical societies have become increasingly dependent on pharmaceutical, device, and biotechnology companies for ongoing support of their programs, but the internal influence of this financial largesse on medical societies' practices is well hidden. Many examples exist in which societies' educational products, including clinical practice guidelines and professional publications, have been tainted by involvement by industry-paid individuals. These examples show that professional judgments of organizations can be affected in ways that are not in the best interests of our patients. Society leaders should develop policies that leave critical decisions, especially those that affect patient care, in the hands of members without financial ties to industry. Society leaders should not accept funds designated for specific industry-recommended projects unless such programs are already part of their planned agenda. These leaders, who typically serve for only a year or two, should delve into arrangements that salaried society executives make with industry, and insure that no promises are made that compromise an organization's professional goals. Professional societies should also find ways of reducing the vast, embarrassing industry involvement at their national meetings, especially the vulgar circus-like displays and the drug company-sponsored symposia. We must reduce commercialism and restore professionalism to our medical meetings.     

News media reports of patient deaths following 'medical tourism' for cosmetic surgery and bariatric surgery

Contemporary scholarship examining clinical outcomes in medical travel for cosmetic surgery identifies cases in which patients traveled abroad for medical procedures and subsequently returned home with infections and other surgical complications. Though there are peer-reviewed articles identifying patient deaths in cases where patients traveled abroad for commercial kidney transplantation or stem cell injections, no scholarly publications document deaths of patients who traveled abroad for cosmetic surgery or bariatric surgery. Drawing upon news media reports extending from 1993 to 2011, this article identifies and describes twenty-six reported cases of deaths of individuals who traveled abroad for cosmetic surgery or bariatric surgery. Over half of the reported deaths occurred in two countries. Analysis of these news reports cannot be used to make causal claims about why the patients died. In addition, cases identified in news media accounts do not provide a basis for establishing the relative risk of traveling abroad for care instead of seeking elective cosmetic surgery at domestic health care facilities. Acknowledging these limitations, the case reports suggest the possibility that contemporary peer-reviewed scholarship is underreporting patient mortality in medical travel. The paper makes a strong case for promoting normative analyses and empirical studies of medical travel. In particular, the paper argues that empirically informed ethical analysis of 'medical tourism' will benefit from rigorous studies tracking global flows of medical travelers and the clinical outcomes they experience. The paper contains practical recommendations intended to promote debate concerning how to promote patient safety and quality of care in medical travel.     

Barriers to provision of dental care in long-term care facilities: the confrontation with ageing and death

Objective: The aim of the study was to reveal barriers to providing dental care for residents in long‐term care (LTC) facilities. Design: Participants were selected randomly from the dentist register in Berlin and Saxony, Germany. The sample consisted of 60 self‐employed and 60 employed dentists, a further 60 dentists worked in their own dental practice but also part‐time in an LTC facility. In semi‐structured interviews a questionnaire with 36 statements concerning working conditions, administration and cost, insecurity concerning treatment decisions as well as confrontation with ageing and death was employed. Subsequently, the study participants were asked to rank the four dimensions concerning their impact on the decision against providing dental care in an LTC facility. Results: The random sample was representative in age and gender for the dental register in Berlin and Saxony. Fifty‐six per cent of the participants (63% of the men and 51% of the women; 52% of the self‐employed, 60% of the employed and 56% of the consultant dentists) indicated unfavourable working conditions as biggest obstacle in providing dental care in an LTC‐facility. Thirty‐two per cent of participants rated administration and cost, 7% the insecurity in treatment decisions as major hindrance. Only 5% of the participants rated the confrontation with age and death as substantial barrier. There were no age and gender differences. Dentists in Berlin seemed more concerned about administration and cost of a consultancy activity and less secure in their therapy decisions than the colleagues from Saxony (p < 0.001). Dentists who work partly in LTC facilities were the least concerned about the confrontation with ageing and death (not significant), employed dentist showed the least secure in their treatment decisions (p > 0.001). Conclusion: It can be concluded that the awareness of infra‐structural and financial aspects in providing dental care in LTC facilities should be raised with health politicians and that these aspects should be considered when inaugurating or re‐structuring the consultancy services to LTC facilities. Further it would be desirable to establish more postgraduate training programmes to increase clinical and ethical competence in the area of gerodontology.     

The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio‐cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio‐economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low‐literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power‐unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research‐related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees.     

Developing Ethical Awareness in Global Health: Four Cases for Medical Educators

In recent years, the growth of interest in global health among medical students and residents has led to an abundance of short‐term training opportunities in low‐resource environments. Given the disparities in resources, needs and expectations between visitors and their hosts, these experiences can raise complex ethical concerns. Recent calls for best practices and ethical guidelines indicate a need for the development of ethical awareness among medical trainees, their sponsoring and host institutions, and supervising faculty. As a teaching tool to promote this awareness, we developed a scenario that captures many common ethical issues from four different perspectives. Each perspective is presented in case format followed by questions. Taken together, the four cases may be used to identify many of the elements of a well‐designed global health training experience.     

TREATMENT NEEDS IN HIV PREVENTION TRIALS: USING BENEFICENCE TO CLARIFY SPONSOR‐INVESTIGATOR RESPONSIBILITIES

Some participants will get HIV‐infected in HIV prevention trials, despite risk reduction measures. The subsequent treatment responsibilities of sponsor‐investigators have been widely debated, especially where access to antiretroviral therapy (ART) is not available. In this paper, we explore two accounts of beneficence to establish whether they can shed light on sponsor‐investigator responsibilities. We find the notion of general beneficence helpful insofar as it clarifies that some beneficent actions will be obligatory where they can be dispensed without scuppering the trial. We find the notion of specific beneficence helpful insofar as it directs investigators to attend to the needs of trial participants; however the range of interventions that could be provided remains unhelpfully broad. We then examine accounts of the investigator‐participant relationship to narrow the range of interventions that investigators should provide, concluding that health‐care, and HIV infection, are appropriate foci. We conclude that when investigators are able to meet the ART needs of their participants (e.g. referral, assisted referral or direct provision) without sacrificing trial quality, they must do so. However, there is little of this explicit direction to be found in the account of specific beneficence itself, but rather it is found in accounts of the relationship that are compatible with beneficence.     

High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey

Introduction

International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported.

Method

Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.

Results

With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation.

Conclusion

Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country''s compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.     

NAVIGATING THE MURKY INTERSECTION BETWEEN CLINICAL AND ORGANIZATIONAL ETHICS: A HYBRID CASE TAXONOMY

Ethical challenges that arise within healthcare delivery institutions are currently categorized as either clinical or organizational, based on the type of issue. Despite this common binary issue‐based methodology, empirical study and increasing academic dialogue indicate that a clear line cannot easily be drawn between organizational and clinical ethics. Disagreement around end‐of‐life treatments, for example, often spawn value differences amongst parties at both organizational and clinical levels and requires a resolution to address both the case at hand and large‐scale underlying system‐level confounders. I refer to issues that contain elements of both clinical and organizational issues as hybrids and propose a new taxonomy to characterize hybrid cases. I contend that salient contextual features of an ethical issue, such as where it is identified, who it impacts and where it is ideally resolved in relation to its scope of impact, should inform procedure. Implementation of a Hybrid taxonomy viewing ethical issues as existing on a continuum furthers that end. The primary goals are to 1) systematize thinking about ethical issues that arise within healthcare delivery institutions and 2) allow the content of the ethical challenge to drive the process, rather than continuing to rely on the traditional binary issue‐based choice. Failure to capture the complexity of hybrid situations perpetuates incomplete information and ultimately an inchoate resolution that creates more questions than answers.