An analysis of common ethical justifications for compassionate use programs for experimental drugs

BACKGROUND: When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill and terminally ill patients are therefore very willing to participate in randomised controlled trials. However, only very few terminally ill patients are able to actually participate, and those that do participate are at risk of participating solely as a way of getting experimental drugs. Currently, there are, however, ways of getting access to drugs that have not (yet) gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs. MAIN BODY: The most frequently voiced justifications for compassionate use or expanded access programs could be put in one of three categories. First, there are justifications of justice, where compassionate use programs could be seen as a just or fair way to distribute experimental new drugs to patients who are denied access to RCT’s through no fault of their own. Second, such programs could be justified by reference to the ethical principle of beneficence where it could be claimed that terminally ill patients stand to benefit greatly at very little risk (as they are already dying). Third, there are considerations of autonomy where, it is claimed, patients should be able to exercise their autonomy and have access to such drugs if that is there free choice and they are fully aware of the risks associated with that choice. SHORT CONCLUSION: In this paper, I argue currently all justifications are potentially problematic. If they truly form the basis for justification, compassionate use programs should be designed to maximize justice, beneficence and autonomy

Continuous sedation at the end of life : practice, perspectives and ethical analyses

Despite advances in palliative medicine, many patients still experience suffering in their last days of life. In cases of severe suffering, there may be no other option than to reduce a patient’s consciousness in order to take away her experience of suffering. This practice, called continuous sedation at the end of life, is the topic of this book. It raises many ethical questions, for example due to its (perceived) similarity with euthanasia, and the fact that it is often combined with withholding artificially administered nutrition and hydration. These and other relevant issues will be discussed in the first part of this dissertation. Subsequently, some of the ‘standard’ ways in which continuous sedation is portrayed in international literature are investigated, and more importantly, their ethical soundness is analysed. In the final part, the ways in which Flemish medical practitioners actually experience continuous sedation at the end of life are discussed, based on the results of a focus group study. As such, this dissertation provides insight into both the ethical and the practical aspects of this increasingly prevalent end of life practice

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. Summary: 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

The patient perspective in health care networks

Background: Health care organization is entering a new age. Focus is increasingly shifting from individual health care institutions to interorganizational collaboration and health care networks. Much hope is set on such networks which have been argued to improve economic efficiency and quality of care. However, this does not automatically mean they are always ethically justified. A relevant question that remains is what ethical obligations or duties one can ascribe to these networks especially because networks involve many risks. Due to their often amorphous and complex structure, collective responsibility and accountability may increase while individual responsibility goes down. Main body: We argue that a business ethics approach to ethical obligations for health care networks, is problematic and we propose to opt for a patient perspective. Using the classic four principles of biomedical ethics (justice, nonmaleficence, beneficence and autonomy) it is possible to identify specific ethical duties. Based on the principle of justice, health care networks have an ethical duty to provide just and fair access for all patients and to be transparent to patients about how access is regulated. The principle of nonmaleficence implies an obligation to guarantee patient safety, whereas the principle of beneficence implies an obligation for health care networks to guarantee continuity of care in all its dimensions. Finally, the principle of autonomy is translated into a specific obligation to promote and respect patient choice. Networks that fail to meet any of these conditions are suspect and cannot be justified ethically. Conclusions: Faced with daunting challenges, the health care system is changing rapidly. Currently many hopes ride on integrated care and broad health care networks. Such networks are the topic of empirical debate, but more attention should be given to the ethical aspects. Health care networks raise new and pressing ethical issues and we are in need of a framework for assessing how and when such networks are justified

Organizing health care networks : balancing markets, government and civil society

Much is changing in health care organization today. A perspective or paradigm that is gaining ever increasing momentum is that of translational, extramural and integrated care. Current research suggests many potential benefits for integrated care and health care networks but the ethical issues are less frequently emphasized. Showing that integrated care can be beneficial, does not mean it is automatically 'ethically' justified. We will argue for three ethical requirements such health care networks should meet. Subsequently we will look at the mechanisms driving the formation of networks and examine how these can cause networks to meet or fail to meet these ethical requirements or obligations. The three mechanisms we will examine are government, civil society and market mechanisms, which, we argue, should be balanced properly. Each mechanism is able to provide a relevant ethical perspective to health care networks. However, when the balance is skewed towards a single mechanism, health care networks might fail to promote one or more of the ethical requirements

Challenges in turning a great idea into great health policy : the case of integrated care

BackgroundIn the organization of health care and health care systems, there is an increasing trend towards integrated care. Policy-makers from different countries are creating policies intended to promote cooperation and collaboration between health care providers, while facilitating the integration of different health care services. Hopes are high, as such collaboration and integration of care are believed to save resources and improve quality. However, policy-makers are likely to encounter various challenges and limitations when attempting to turn these great ideas into effective policies. In this paper, we look into these challenges.Main bodyWe argue that the organization of health care and integrated care is of public concern, and should thus be of crucial interest to policy-makers. We highlight three challenges or limitations likely to be encountered by policy-makers in integrated care. These are: (1) conceptual challenges; (2) empirical/methodological challenges; and (3) resource challenges. We will argue that it is still unclear what integrated care means and how we should measure it. 'Integrated care' is a single label that can refer to a great number of different processes. It can describe the integration of care for individual patients, the integration of services aimed at particular patient groups or particular conditions, or it can refer to institution-wide collaborations between different health care providers. We subsequently argue that health reform inevitably possesses a political context that should be taken into account. We also show how evidence supporting integrated care may not guarantee success in every context. Finally, we will discuss how promoting collaboration and integration might actually demand more resources. In the final section, we look at three different paradigmatic examples of integrated care policy: Norway, the UK's NHS, and Belgium.ConclusionsThere seems widespread agreement that collaboration and integration are the way forward for health care and health care systems. Nevertheless, we argue that policy-makers should remain careful; they should carefully consider what they hope to achieve, the amount of resources they are willing to invest, and how they will evaluate the success of their policy

Defining moral enhancement: a clarificatory taxonomy

Recently there has been some discussion concerning a particular type of enhancement, namely 'moral enhancement'. However, there is no consensus on what precisely constitutes moral enhancement, and as a result the concept is used and defined in a wide variety of ways. In this article, we develop a clarificatory taxonomy of these definitions and we identify the criteria that are used to delineate the concept. We think that the current definitions can be distinguished from each other by the criteria used for determining whether an intervention is indeed moral enhancement. For example, some definitions are broad and include moral enhancement by any means, while other definitions focus only on moral enhancement by means of specific types of intervention (e.g. biomedical or genetic interventions). Moreover, for some definitions it suffices for an intervention to be aimed or intended to morally enhance a person, while other definitions only refer to 'moral enhancement' in relation to interventions that are actually effective. For all these differences in definitions we discuss some of their ( more normative) implications. This shows that definitions are significantly less descriptive and more normative than they are regularly portrayed to be. We therefore hope that the taxonomy developed in this paper and the comments on the implications for the normative debate of the variety of definitions will provide conceptual clarity in a complex and highly interesting debate