The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should prohibit all other, lower-quality (...) research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated. (shrink)

Harms of medical interventions are systematically underestimated in clinical research. Numerous factors—conceptual, methodological, and social—contribute to this underestimation. I articulate the depth of such underestimation by describing these factors at the various stages of clinical research. Before any evidence is gathered, the ways harms are operationalized in clinical research contributes to their underestimation. Medical interventions are first tested in phase 1 ‘first in human’ trials, but evidence from these trials is rarely published, despite the fact that such trials provide the (...) foundation for assessing the harm profile of medical interventions. If a medical intervention is deemed safe in a phase 1 trial, it is tested in larger phase 2 and 3 clinical trials. One way to think about the problem of underestimating harms is in terms of the statistical ‘power’ of a clinical trial—the ability of a trial to detect a difference of a certain effect size between the experimental group and the control group. Power is normally thought to be pertinent to detecting benefits of medical interventions. It is important, though, to distinguish between the ability of a trial to detect benefits and the ability of a trial to detect harms. I refer to the former as power-B and the latter as power-H. I identify several factors that maximize power-B by sacrificing powerH in phase 3 clinical trials. If a medical intervention is approved for general use, it is evaluated by phase 4 post-market surveillance. Phase 4 surveillance of harms further contributes to underestimating the harm profile of medical interventions. At every stage of clinical research the hunt for harms is shrouded in secrecy, which further contributes to the underestimation of the harm profiles of medical interventions. (shrink)

Underdetermination arguments support the conclusion that no amount of empirical data can uniquely determine theory choice. The full content of a theory outreaches those elements of it (the observational elements) that can be shown to be true (or in agreement with actual observations).2 A number of strategies have been developed to minimize the threat such arguments pose to our aspirations to scientific knowledge. I want to focus on one such strategy: the invocation of additional criteria drawn from a pool of (...) cognitive or theoretical values, such as simplicity or generality, to bolster judgements about the worth of models, theories, and hypotheses. What is the status of such criteria? Larry Laudan, in Science and Values, argued that cognitive values could not be treated as self-validating, beyond justification, but are embedded in a three-way reticulational system containing theories, methods, and aims or values, which are involved in mutually supportive relationships (Laudan, 1984). My interest in this paper is not the purportedly self-validating nature of cognitive values, but their cognitive nature. Although Laudan rejects the idea that what he calls cognitive values are exempt from rational criticism and disagreement, he does seem to think that the reticulational system he identifies is independent of non-cognitive considerations. It is this cognitive/non-cognitive distinction that I wish to query in this paper. Let me begin by summarizing those of my own views about inquiry in which this worry about the distinction arises. (shrink)

Douglas proposes a new ideal in which values serve an essential function throughout scientific inquiry, but where the role values play is constrained at key points, protecting the integrity and objectivity of science.

This is an important book precisely because there is none other quite like it.

In this paper we make a proposal for reforming biomedical research that is aimed to align re-search more closely with the so-called fair-share principle according to which the proportions of global resources as-signed to different diseases should agree with the ratios of human suffering associated with those diseases.

This paper explores a number of recent proposals regarding "feminist science" and rejects a content-based approach in favor of a process-based approach to characterizing feminist science. Philosophy of science can yield models of scientific reasoning that illuminate the interaction between cultural values and ideology and scientific inquiry. While we can use these models to expose masculine and other forms of bias, we can also use them to defend the introduction of assumptions grounded in feminist political values.

One-third of all human lives end in early death from poverty-related causes. Most of these premature deaths are avoidable through global institutional reforms that would eradicate extreme poverty. Many are also avoidable through global health-system reform that would make medical knowledge freely available as a global public good. The rules should be redesigned so that the development of any new drug is rewarded in proportion to its impact on the global disease burden (not through monopoly rents). This reform would bring (...) drug prices down worldwide close to their marginal cost of production and would powerfully stimulate pharmaceutical research into currently neglected diseases concentrated among the poor. Its feasibility shows that the existing medical-patent regime (trade-related aspects of intellectual property rights—TRIPS—as supplemented by bilateral agreements) is severely unjust—and its imposition a human-rights violation on account of the avoidable mortality and morbidity it foreseeably produces. (shrink)

We argue that the health sciences make causal claims on the basis of evidence both of physical mechanisms, and of probabilistic dependencies. Consequently, an analysis of causality solely in terms of physical mechanisms or solely in terms of probabilistic relationships, does not do justice to the causal claims of these sciences. Yet there seems to be a single relation of cause in these sciences - pluralism about causality will not do either. Instead, we maintain, the health sciences require a theory (...) of causality that unifies its mechanistic and probabilistic aspects. We argue that the epistemic theory of causality provides the required unification. (shrink)

The question of the relationship of the making of value judgments in a typically ethical sense to the methods and procedures of science has been discussed in the literature at least to that point which e. e. cummings somewhere refers to as “The Mystical Moment of Dullness.” Nevertheless, albeit with some trepidation, I feel that something more may fruitfully be said on the subject.

Although epistemic values have become widely accepted as part of scientific reasoning, non-epistemic values have been largely relegated to the "external" parts of science (the selection of hypotheses, restrictions on methodologies, and the use of scientific technologies). I argue that because of inductive risk, or the risk of error, non-epistemic values are required in science wherever non-epistemic consequences of error should be considered. I use examples from dioxin studies to illustrate how non-epistemic consequences of error can and should be considered (...) in the internal stages of science: choice of methodology, characterization of data, and interpretation of results. (shrink)

Medical nihilism is the view that we should have little confidence in the effectiveness of medical interventions. Jacob Stegenga argues persuasively that this is how we should see modern medicine, and suggests that medical research must be modified, clinical practice should be less aggressive, and regulatory standards should be enhanced.

Exploring the role of values in scientific inquiry, Hugh Lacey examines the nature and meaning of values, and looks at challenges to the view, posed by postmodernists, feminists, radical ecologists, Third-World advocates and religious fundamentalists, that science is value free. He also focuses on discussions of 'development', especially in Third World countries. This paperback edition includes a new preface.

What kind of knowledge is medical knowledge? Can medicine be explained scientifically? Is disease a scientific concept, or do explanations of disease depend on values? What is ‘evidence-based’ medicine? Are advances in neuroscience bringing us closer to a scientific understanding of the mind? The nature of medicine raises fundamental questions about explanation, causation, knowledge and ontology – questions that are central to philosophy as well as medicine. In this book Paul R. Thompson and Ross E. G. Upshur introduce the fundamental (...) issues in philosophy of medicine for those coming to the subject for the first time. They introduce and explain the following key topics: Understanding the physician-patient relationship: the phenomenology of the medical encounter. Models and theories in biology and medicine: what role do theories play in medicine? Are they similar to scientific theories? Randomised controlled trials: can scientific experiments be replicated in clinical medicine? What are the philosophical criticisms levelled at RCTs? The concept of evidence in medical research: what do we mean by ‘Evidence-based medicine?’ Should all medicine be based on evidence? Causation in medicine What do advances in neuroscience reveal about the relationship between mind and body? Defining health and disease: are explanations of disease objective or do they depend on values? Evolutionary medicine: what is the role of evolutionary biology in understanding medicine? Is it relevant? Extensive use of empirical examples and case studies is made throughout the book. These include debates about smoking and cancer, the use of placebos in randomised controlled trials and controversies about research into the causes of HIV and autism. This is an indispendable introduction to those teaching philosophy of medicine and philosophy of science. (shrink)

Published research findings are sometimes refuted by subsequent evidence, says Ioannidis, with ensuing confusion and disappointment.

Evidence-based medicine has always required integration of patient values with ‘best’ clinical evidence. It is widely recognized that scientific practices and discoveries, including those of EBM, are value-laden. But to date, the science of EBM has focused primarily on methods for reducing bias in the evidence, while the role of values in the different aspects of the EBM process has been almost completely ignored.

As health care embraces the tenets of evidence-based medicine it is important to ask questions about how evidence is produced and interpreted. This essay explores normative dimensions of evidence production, particularly around issues of setting the tolerable level of uncertainty of results. Four specific aspects are explored: what health care providers know about statistics, why alpha levels have been set at 0.05, the role of randomization in the generation of sufficient grounds of belief, and the role of observational studies. The (...) essay concludes with recommendations to acknowledge the value permeation of outcome measures and suggests that attention to reasoning and argument analysis can augment traditional evidence-based approaches in providing a robust critical approach to medical knowledge. (shrink)

Claims that science should be more democratic than it is frequently arouse opposition. In this essay, I distinguish my own views about the democratization of science from the more ambitious theses defended by Paul Feyerabend. I argue that it is unlikely that the complexity of some scientific debates will allow for resolution according to the methodological principles of any formal confirmation theory, suggesting instead that major revolutions rest on conflicts of values. Yet these conflicts should not be dismissed as irresoluble.

In this book, one of the world's preeminent philosophers takes issue with an idea that has found an all-too-prominent place in popular culture and philosophical ...