Reidar K. Lie

Priority setting in health care: Lessons from the experiences of eight countries

All health care systems face problems of justice and efficiency related to setting priorities for allocating a limited pool of resources to a population. Because many of the central issues are the same in all systems, the United States and other countries can learn from the successes and failures of countries that have explicitly addressed the question of health care priorities.We review explicit priority setting efforts in Norway, Sweden, Israel, the Netherlands, Denmark, New Zealand, the United Kingdom and the state of Oregon in the US. The approaches used can be divided into those centered on outlining principles versus those that define practices. In order to establish the main lessons from their experiences we consider (1) the process each country used, (2) criteria to judge the success of these efforts, (3) which approaches seem to have met these criteria, and (4) using their successes and failures as a guide, how to proceed in setting priorities. We demonstrate that there is little evidence that establishment of a values framework for priority setting has had any effect on health policy, nor is there evidence that priority setting exercises have led to the envisaged ideal of an open and participatory public involvement in decision making.

The standard of care debate: the Declaration of Helsinki versus the international consensus opinion

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that there is also consensus regarding the broad conditions under which this is acceptable.

Circumcision and HIV prevention research: an ethical analysis

A large randomised controlled trial in 3274 men between the ages of 18 and 24 years showed that circumcision resulted in a significant 60% reduction in HIV infection. If these results were to be confirmed by two continuing (unpublished) trials there would be grounds to advocate circumcision as a public health intervention in high prevalence areas. Several ethical issues arose in relation to this trial such as the decision not to disclose participants HIV status to them during the trial the decision to pay participants and early termination at the request of the trials monitoring board. We address the ethical implications for future HIV prevention research both for biological interventions such as vaccine and microbicide trials and for behavioural interventions such as counselling. First is there an ethical obligation to provide all male participants in future trials of HIV vaccines and other preventive methods with circumcision (as well as counselling and access to condoms)? Second should future prevention trials select or stratify participants by circumcision status? Third should the design of such trials be altered in light of the established effectiveness of circumcision--eg by requiring circumcision for the control groups? (excerpt)

Ethics of Future Disclosure of Individual Risk Information in a Genetic Cohort Study: A Survey of Donor Preferences

Background Although genetic epidemiologic research has added an element of individualization to epidemiologic research, there is neither agreement nor much discussion on whether donors of genetic samples should be offered an opportunity to receive individualized results regarding their genetic susceptibility to disease. Little is known regarding donors’ preferences for future disclosure of individual results. The purpose of this study is to investigate the actual preferences of such donors with regard to receiving individual results, to explore the factors related to their decision, and then to discuss ethical issues regarding the disclosure of results. Methods Participants (n = 1857) of an ongoing Japanese population-based genetic cohort study in Takashima, Shiga, in 2003, were asked at entry about their preferences with regard being recontacted by researchers in the future and whether they wanted to receive reports on their individual genetic results if genetic problems relevant to their health are discovered for which efficacious interventions might be available. Results Most of the donors wished to be recontacted and receive reports, but some did not want any reports. Those who were younger, former/current drinkers, or had at least 1 parent who had had cancer were more likely to want the results, while those who had at least 1 sibling with a medical history of cancer were less likely to want the results. Conclusion We observed a high level of positive preference for future disclosure of individual genetic results, which is in line with the professional views on the ethics of this issue. A well-considered procedure for ascertaining donors’ preferences for receiving the results of the research is required from an ethical perspective.

Effects of isoproterenol on the dense core and perigranular membrane of atrial specific granules

SummaryFollowing subcutaneous injections of isoproterenol hydrochloride (ISO), atrial cells present a large number of partly degranulated or completely clear “specific granules” enclosed by an intact membrane. Such profiles were never encountered in normal controls and might suggest ISO-induced release of a secretory product. Permeability of perigranular membrane was tested using the extracellular macromolecular tracer horseradish peroxidase (HRP). Reaction product was entirely absent within granules of atrial cells in which the sarcolemma was made permeable to HRP molecules by the ISO injections. This seemed to be the case even in heavily labelled cells in which the peroxidase had penetrated the mitochondrial membranes. In atrial cells impermeable to the tracer, the specific granules closely apposed to the sarcolemma were always HRP-negative. The release mechanism of a possible secretory substance from the specific granules is discussed.

Effect of isoproterenol on lipid accumulation in myocardial cells

SummaryPlasma free fatty acid (FFA) levels and myocardial accumulation of lipid droplets were studied in mice receiving 85 mg isoproterenol (ISP)/kg b.wt. with and without pretreatment with nicotinic acid (NA) 30 min before ISP injection, and in saline-injected controls. The animals were killed 30 min after the ISP injection. Plasma FFA were determined by a radiochemical method. Lipid droplet accumulation was analyzed by quantitative stereologic techniques. Plasma FFA were raised from 505.8±15.7 to 1,808.8±87.8µmol/l after ISP treatment and to 1,108.0±34.7µmol/l in the group receiving NA pretreatment. However, NA pretreatment did not bring about a corresponding decrease in the fractional volume of lipid droplets, as both groups showed an increase of five times that of the controls.These results are discussed in terms of the pathogenesis of ISP-induced lipid accumulation.

Principles versus procedures in making health care coverage decisions: addressing inevitable conflicts.

It has been suggested that focusing on procedures when setting priorities for health care avoids the conflicts that arise when attempting to agree on principles. A prominent example of this approach is “accountability for reasonableness.” We will argue that the same problem arises with procedural accounts; reasonable people will disagree about central elements in the process. We consider the procedural condition of appeal process and three examples of conflicts over coverage decisions: a patients’ rights law in Norway, health technologies coverage recommendations in the UK, and care withheld by HMOs in the US. In each case a process is at the center of controversy, illustrating the difficulties in establishing procedures that are widely accepted as legitimate. Further work must be done in developing procedural frameworks.

ETHICS OF RESOURCE ALLOCATION IN DEVELOPING COUNTRIES: THE CASE OF SRI LANKA

The issues of prioritization of health care services and allocation of resources have recently received increasing attention and discussion. Several reports have been published by governments in different countries and the issues are discussed in many recent books and papers. In this paper the focus is on the problems faced by a developing country when allocation of health care resources is considered. We consider these issues under three headings and exemplify the situation in a developing country by taking Sri Lanka as an example. Firstly the evidence to formulate an ethical basis for the existing health care system in Sri Lanka is discussed, in particular the problem of defining a minimum quality of health care for the population. Secondly, we consider the issues which arise when we want to formulate the ethical basis for health sector reform. In particular, we examine current World Bank proposals. We shall argue that there are a number of important conceptual and ethical issues that have not been properly addressed in the various policy documents. Finally, we introduce our own alternative ethical framework for policy reform.

Attitudes towards transfers of human tissue samples across borders: an international survey of researchers and policy makers in five countries.

BackgroundSharing of tissue samples for research and disease surveillance purposes has become increasingly important. While it is clear that this is an area of intense, international controversy, there is an absence of data about what researchers themselves and those involved in the transfer of samples think about these issues, particularly in developing countries.MethodsA survey was carried out in a number of Asian countries and in Egypt to explore what researchers and others involved in research, storage and transfer of human tissue samples thought about some of the issues related to sharing of such samples.ResultsThe results demonstrated broad agreement with the positions taken by developing countries in the current debate, favoring quite severe restrictions on the use of samples by developed countries.ConclusionsIt is recommended that an international agreement is developed on what conditions should be attached to any sharing of human tissue samples across borders.

Research ethics and evidence based medicine

In this paper, the author argues that the requirement to conduct randomised clinical trials to inform policy in cases where one wants to identify a cheaper alternative to known effective but expensive interventions raises an important ethical issue. This situation will eventually arise whenever there are resource constraints, and a policy decision has been made not to fund an intervention on cost effectiveness grounds. It has been thought that this is an issue only in extremely resource poor settings. This paper gives an example from the United Kingdom illustrating that this is also a problem faced by richer countries.