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10 recordsLinked to original sources
PubMed2004

Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.

The concept of 'equipoise', or the 'uncertainty principle', has been represented as a central ethical principle, and holds that a subject may be enrolled in a randomized controlled trial (RCT) only if there is true uncertainty about which of the trial arms is most likely to benefit the patient. We sought to estimate the frequency with which equipoise conditions were met in industry-sponsored RCTs in rheumatology, to explore the reasons for any deviations from equipoise, to examine the concept of 'design bias', and to consider alternative ethical formulations that might improve subject safety and autonomy. We studied abstracts accepted for the 2001 American College of Rheumatology meetings that reported RCTs, acknowledged industry sponsorship, and had clinical end-points (n = 45), and examined the proportion of studies that favored the registration or marketing of the sponsor's drug. In every trial (45/45) results were favorable to the sponsor, indicating that results could have been predicted in advance solely by knowledge of sponsorship (P < 0.0001). Equipoise clearly was being systematically violated. Publication bias appeared to be an incomplete explanation for this dramatic result; this bias occurs after a study is completed. Rather, we hypothesize that 'design bias', in which extensive preliminary data are used to design studies with a high likelihood of being positive, is the major cause of the asymmetric results. Design 'bias' occurs before the trial is begun and is inconsistent with the equipoise principle. However, design bias increases scientific efficiency, decreases drug development costs, and limits the number of subjects required, probably reducing aggregate risks to participants. Conceptual and ethical issues were found with the equipoise principle, which encourages performance of negative studies; ignores patient values, patient autonomy, and social benefits; is applied at a conceptually inappropriate decision point (after randomization rather than before); and is in conflict with the Belmont, Nuremberg, and other sets of ethical principles, as well as with US Food and Drug Administration procedures. We propose a principle of 'positive expected outcomes', which informs the assessment that a trial is ethical, together with a restatement of the priority of personal autonomy.

Bias↗
PubMed1998

Resource constraints and moral pressures: can we still afford ourselves?

We have reached a phase of diminishing returns in medicine. Increasing costs produce smaller and smaller incremental benefits in health status. Medical scientists continue to work within the ideology of the Enlightenment, whereby advances in knowledge will eventually lead to control of health and welfare. The enormous costs of this ideology have led to two new ideologies: those of economic rationalism and managerialism. At the public level, the Western liberal emphasis on the value of individual life is generally held to justify the amount of public money spent on health. Those who frame health policy are influenced to some extent by this ideal, but we cannot continue to develop costly interventions without constraint. To overcome this impasse, we might accept that economic rationalism provided a proper base for health care; or we might redefine disease so that more people were excluded from treatment programmes; or we might agree to limit medical research in costly areas; we might change our ethical thinking to emphasize classical utilitarianism; or we might undertake systematic studies of community values and opinions to find out what people really want from their health and welfare services. There are serious ethical problems with each of these solutions, except for the last: the idea of modifying services to take note of community values. Testing community values is difficult, but there are ways of doing it, and there have been some exercises in which the process has been undertaken with some success. The recent Constitutional convention suggests that it may even be possible in Australia.

Cost Control↗
PubMed2006

North-South benefit sharing arrangements in bioprospecting and genetic research: a critical ethical and legal analysis.

Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of 'community' presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments' responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.

Biodiversity↗