Controversies surrounding continuous deep sedation at the end of life: the parliamentary and societal debates in France.

BACKGROUND: Continuous deep sedation at the end of life is a practice that has been the topic of considerable ethical debate, for example surrounding its perceived similarity or dissimilarity with physician-assisted dying. The practice is generally considered to be legal as a form of symptom control, although this is mostly only assumed. France has passed an amendment to the Public Health Act that would grant certain terminally ill patients an explicit right to continuous deep sedation until they pass away. Such a framework would be unique in the world. DISCUSSION: In this paper we will highlight and reflect on four relevant aspects and shortcomings of the proposed bill. First, that the bill suggests that continuous deeps sedation should be considered as a sui generis practice. Second, that it requires that sedation should always be accompanied by the withholding of all artificial nutrition and hydration. In the most recently amended version of the legal proposal it is stated that life sustaining treatments are withheld unless the patient objects. Third, that the French bill would not require that the suffering for which continuous deep sedation is initiated is unbearable. Fourth, the question as to whether the proposal should be considered as a way to avoid having to decriminalise euthanasia and/or PAS or, on the contrary, as a veiled way to decriminalise these practices. The French proposal to amend the Public Health Act to include a right to continuous deep sedation for some patients is a unique opportunity to clarify the legality of continuous deep sedation as an end-of-life practice. Moreover, it would recognize that the practice of continuous deep sedation raises ethical and legal issues that are different from those raised by symptom control on the one hand and assisted dying on the other hand. Nevertheless, there are still various issues of significant ethical concern in the French legislative proposal.

How defining clinical practices may influence their evaluation: the case of continuous sedation at the end of life.

RATIONALE, AIMS AND OBJECTIVES: Continuous sedation at the end of life is an end-of-life practice that has gained considerable attention in the international literature. Nevertheless, significant confusion persists, even on how to label or define the practice. Several different terms and definitions exist, and these are often non-neutral and indicative of one's normative position on sedation at the end of life. This is problematic for two reasons. First, the use of such value-laden terms or definitions of continuous sedation may make it difficult, if not impossible, to agree on the facts surrounding continuous sedation. Second, including normative criteria in a definition can lead one to make disguised circular or tautological statements. METHODS: This paper identifies commonly used terms and definitions and demonstrates how particular elements present in these are value-laden and can influence the ethical evaluation of continuous sedation at the end of life. RESULTS: Two commonly used terms, 'palliative sedation' and 'terminal sedation', have been strongly criticized. We propose to use another, more descriptive term, namely 'continuous sedation at the end of life'. As regards the different definitions of sedation, some are general, but most contain very specific elements, thereby clearly limiting the number of cases that are covered by the definition. Some definitions of sedation include the intention one should (not) have, the possible indications for the practice, and the type of patients the practice should be reserved for. CONCLUSION: Including value-laden elements in the very definition of a clinical practice runs the risk of pre-empting a proper normative debate about the practice. We explain why this is the case and why it is problematic, and we propose an alternative, descriptive, definition that seeks to avoid these problems.

Governing the postmortem procurement of human body material for research.

Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research participant. In this paper, we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent.

The language of sedation in end-of-life care: The ethical reasoning of care providers in three countries.

The application of ethically controversial medical procedures may differ from one place to another. Drawing on a keyword and text-mining analysis of 156 interviews with doctors and nurses involved in end-of-life care ('care providers'), differences between countries in care providers' ethical rationales for the use of sedation are reported. In the United Kingdom, an emphasis on titrating doses proportionately against symptoms is more likely, maintaining consciousness where possible. The potential harms of sedation are perceived to be the potential hastening of social as well as biological death. In Belgium and the Netherlands, although there is concern to distinguish the practice from euthanasia, rapid inducement of deep unconsciousness is more acceptable to care providers. This is often perceived to be a proportionate response to unbearable suffering in a context where there is also greater pressure to hasten dying from relatives and others. This means that sedation is more likely to be organised like euthanasia, as the end 'moment' is reached, and family farewells are organised before the patient is made unconscious for ever. Medical and nursing practices are partly responses to factors outside the place of care, such as legislation and public sentiment. Dutch guidelines for sedation largely tally with the practices prevalent in the Netherlands and Belgium, in contrast with those produced by the more international European Association for Palliative Care whose authors describe an ethical framework closer to that reportedly used by UK care providers.

Using continuous sedation until death for cancer patients: a qualitative interview study of physicians' and nurses' practice in three European countries.

BACKGROUND: Extensive debate surrounds the practice of continuous sedation until death to control refractory symptoms in terminal cancer care. We examined reported practice of United Kingdom, Belgian and Dutch physicians and nurses. METHODS: Qualitative case studies using interviews. SETTING: Hospitals, the domestic home and hospices or palliative care units. PARTICIPANTS: In all, 57 Physicians and 73 nurses involved in the care of 84 cancer patients. RESULTS: UK respondents reported a continuum of practice from the provision of low doses of sedatives to control terminal restlessness to rarely encountered deep sedation. In contrast, Belgian respondents predominantly described the use of deep sedation, emphasizing the importance of responding to the patient's request. Dutch respondents emphasized making an official medical decision informed by the patient's wish and establishing that a refractory symptom was present. Respondents employed rationales that showed different stances towards four key issues: the preservation of consciousness, concerns about the potential hastening of death, whether they perceived continuous sedation until death as an 'alternative' to euthanasia and whether they sought to follow guidelines or frameworks for practice. CONCLUSION: This qualitative analysis suggests that there is systematic variation in end-of-life care sedation practice and its conceptualization in the United Kingdom, Belgium and the Netherlands.

Continuous sedation until death: the everyday moral reasoning of physicians, nurses and family caregivers in the UK, The Netherlands and Belgium.

BACKGROUND: Continuous sedation is increasingly used as a way to relieve symptoms at the end of life. Current research indicates that some physicians, nurses, and relatives involved in this practice experience emotional and/or moral distress. This study aims to provide insight into what may influence how professional and/or family carers cope with such distress. METHODS: This study is an international qualitative interview study involving interviews with physicians, nurses, and relatives of deceased patients in the UK, The Netherlands and Belgium (the UNBIASED study) about a case of continuous sedation at the end of life they were recently involved in. All interviews were transcribed verbatim and analysed by staying close to the data using open coding. Next, codes were combined into larger themes and categories of codes resulting in a four point scheme that captured all of the data. Finally, our findings were compared with others and explored in relation to theories in ethics and sociology. RESULTS: The participants' responses can be captured as different dimensions of 'closeness', i.e. the degree to which one feels connected or 'close' to a certain decision or event. We distinguished four types of 'closeness', namely emotional, physical, decisional, and causal. Using these four dimensions of 'closeness' it became possible to describe how physicians, nurses, and relatives experience their involvement in cases of continuous sedation until death. More specifically, it shined a light on the everyday moral reasoning employed by care providers and relatives in the context of continuous sedation, and how this affected the emotional impact of being involved in sedation, as well as the perception of their own moral responsibility. CONCLUSION: Findings from this study demonstrate that various factors are reported to influence the degree of closeness to continuous sedation (and thus the extent to which carers feel morally responsible), and that some of these factors help care providers and relatives to distinguish continuous sedation from euthanasia.

Continuous deep sedation at the end of life and the 'natural death' hypothesis.

Surveys in different countries (e.g. the UK, Belgium and The Netherlands) show a marked recent increase in the incidence of continuous deep sedation at the end of life (CDS). Several hypotheses can be formulated to explain the increasing performance of this practice. In this paper we focus on what we call the 'natural death' hypothesis, i.e. the hypothesis that acceptance of CDS has spread rapidly because death after CDS can be perceived as a 'natural' death by medical practitioners, patients' relatives and patients. We attempt to show that the label 'natural' cannot be unproblematically applied to the nature of this end-of-life practice. We argue that the labeling of death following CDS as 'natural' death is related to a complex set of mechanisms which facilitate the use of this practice. However, our criticism does not preclude the view that CDS may be clinically and ethically justified in many cases.

Are natural products and medical diagnostic tests still eligible for patents in the USA?

In 2010, the biotechnology and molecular diagnostics industries were shocked by the decision from a US District Court to the effect that isolated endogenous DNA and diagnostic tests based on newly discovered DNA sequences were not eligible for US patents. The case related to the BRCA1/2 genes for breast and ovarian cancer. On appeal, the decision was almost entirely overturned. However, in March 2012, the US Supreme Court vacated the appeal court decision and instructed the appeals court to rehear the case in the light of its very recent decision, which suggested that products of nature and their obvious uses should not be patentable. This commentary explores the points at issue.

Is continuous sedation at the end of life an ethically preferable alternative to physician-assisted suicide?

The relatively new practice of continuous sedation at the end of life (CS) is increasingly being debated in the clinical and ethical literature. This practice received much attention when a U.S. Supreme Court ruling noted that the availability of CS made legalization of physician-assisted suicide (PAS) unnecessary, as CS could alleviate even the most severe suffering. This view has been widely adopted. In this article, we perform an in-depth analysis of four versions of this "argument of preferable alternative." Our goal is to determine the extent to which CS can be considered to be an alternative to PAS and to identify the grounds, if any, on which CS may be ethically preferable to PAS.

The perspectives of clinical staff and bereaved informal care-givers on the use of continuous sedation until death for cancer patients: The study protocol of the UNBIASED study.

BACKGROUND: A significant minority of dying people experience refractory symptoms or extreme distress unresponsive to conventional therapies. In such circumstances, sedation may be used to decrease or remove consciousness until death occurs. This practice is described in a variety of ways, including: 'palliative sedation', 'terminal sedation', 'continuous deep sedation until death', 'proportionate sedation' or 'palliative sedation to unconsciousness'. Surveys show large unexplained variation in incidence of sedation at the end of life across countries and care settings and there are ethical concerns about the use, intentions, risks and significance of the practice in palliative care. There are also questions about how to explain international variation in the use of the practice. This protocol relates to the UNBIASED study (UK Netherlands Belgium International Sedation Study), which comprises three linked studies with separate funding sources in the UK, Belgium and the Netherlands. The aims of the study are to explore decision-making surrounding the application of continuous sedation until death in contemporary clinical practice, and to understand the experiences of clinical staff and decedents' informal care-givers of the use of continuous sedation until death and their perceptions of its contribution to the dying process. The UNBIASED study is part of the European Association for Palliative Care Research Network. METHODS/DESIGN: To realize the study aims, a two-phase study has been designed. The study settings include: the domestic home, hospital and expert palliative care sites. Phase 1 consists of: a) focus groups with health care staff and bereaved informal care-givers; and b) a preliminary case notes review to study the range of sedation therapy provided at the end of life to cancer patients who died within a 12 week period. Phase 2 employs qualitative methods to develop 30 patient-centred case studies in each country. These involve interviews with staff and informal care-givers closely involved in the care of cancer patients who received continuous sedation until death. DISCUSSION: To our knowledge, this is one of the few studies which seek to take a qualitative perspective on clinical decision making surrounding the use of continuous sedation until death and the only one which includes the perspectives of nurses, physicians, as well as bereaved informal care-givers. It has several potential strengths, weaknesses, opportunities and threats associated with the specific design of the study, as well as with the sensitive nature of the topic and the different frameworks for ethical review in the participating countries.