The requirement that animals be used in research and testing in order to protect humans was formalized in the Nuremberg Code and subsequent national and international laws, codes, and declarations. We review the history of these requirements and contrast what was known via science about animal models then with what is known now. We further analyze the predictive value of animal models when used as test subjects for human response to drugs and disease. We explore the use of animals for (...) models in toxicity testing as an example of the problem with using animal models. We conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and prevent otherwise safe and efficacious drugs and therapies from being implemented. (shrink)

What role do nonhuman animals play in the construction of medical knowledge? Animal researchers typically claim that their use has been essential to progress – but just how have animals fitted into the development of biomedicine? In this article, I trace how nonhuman animals, and their body parts, have become incorporated into laboratory processes and places. They have long been designed to fit into scientific procedures – now increasingly so through genetic design. Animals and procedures are closely connected – animals (...) in science are disassembled and reassembled in various ways. Indeed, biomedical knowledge can be said to rest on a large pile of animal bodies and body parts. The process of producing animal body parts to order has implications for how we conceptualize the body (human or nonhuman), which I discuss in the final section. (shrink)

The new mechanists and the autonomy approach both aim to account for how biological phenomena are explained. One identifies appeals to how components of a mechanism are organized so that their activities produce a phenomenon. The other directs attention towards the whole organism and focuses on how it achieves self-maintenance. This paper discusses challenges each confronts and how each could benefit from collaboration with the other: the new mechanistic framework can gain by taking into account what happens outside individual mechanisms, (...) while the autonomy approach can ground itself in biological research into how the actual components constituting an autonomous system interact and contribute in different ways to realize and maintain the system. To press the case that these two traditions should be constructively integrated we describe how three recent developments in the autonomy tradition together provide a bridge between the two traditions: (1) a framework of work and constraints, (2) a conception of function grounded in the organization of an autonomous system, and (3) a focus on control. (shrink)

In the long history of moral theory, non-human animals—hereafter, just animals—have often been neglected entirely or have been relegated to some secondary status. Since its emergence in the early 19th century, utilitarianism has made a difference in that respect by focusing upon happiness or well-being (and their contraries) rather than upon the beings who suffer or enjoy. Inevitably, that has meant that human relations to and use of other animals have appeared in a different light. Some cases have seemed easy: (...) once admit that the interests of animals matter and there can be little hesitation in condemning their cruel treatment. Among the more difficult cases has been the bearing of utilitarianism upon the use of animals in various kinds of research where, though the animals might suffer, there were believed to be prospects of great human benefit and where no cruel or malicious motives need be involved. What I shall provide in the current paper is an extended discussion of the bearing of utilitarianism upon practices of animal research. Since such practices have attracted both utilitarian criticism and defense, this will require the examination of arguments on both sides, including consideration of the human benefits, the animal costs, and the ways in which the one can be weighed against the other. (shrink)

ArgumentWe examine the criteria used to validate the use of nonhuman organisms in North-American alcohol addiction research from the 1950s to the present day. We argue that this field, where the similarities between behaviors in humans and non-humans are particularly difficult to assess, has addressed questions of model validity by transforming the situatedness of non-human organisms into an experimental tool. We demonstrate that model validity does not hinge on the standardization of one type of organism in isolation, as often the (...) case with genetic model organisms. Rather, organisms are viewed as necessarily situated: they cannot be understood as a model for human behavior in isolation from their environmental conditions. Hence the environment itself is standardized as part of the modeling process; and model validity is assessed with reference to the environmental conditions under which organisms are studied. (shrink)

Ethics, Policy & Environment, Volume 15, Issue 2, Page 234-236, June 2012.

P.F. Strawson’s work on moral responsibility is well-known. However, an important implication of the landmark “Freedom and Resentment” has gone unnoticed. Specifically, a natural development of Strawson’s position is that we should understand being morally responsible as having externalistically construed pragmatic criteria, not individualistically construed psychological ones. This runs counter to the contemporary ways of studying moral responsibility. I show the deficiencies of such contemporary work in relation to Strawson by critically examining the positions of John Martin Fischer and Mark (...) Ravizza, R. Jay Wallace, and Philip Pettit for problems due to individualistic assumptions. (shrink)

Francesco Guala once wrote that ‘The problem of extrapolation is a minor scandal in the philosophy of science’. This paper agrees with the statement, but for reasons different from Guala’s. The scandal is not, or not any longer, that the problem has been ignored in the philosophy of science. The scandal is that framing the problem as one of external validity encourages poor evidential reasoning. The aim of this paper is to propose an alternative—an alternative which constitutes much better evidential (...) reasoning about target systems of interest, and which makes do without consideration of external validity. (shrink)

Extrapolation from a well-understood base population to a less-understood target population can fail if the base and target populations are not sufficiently similar. Differences between laboratory mice and humans, for example, can hinder extrapolation in medical research. Mice that carry a partial or complete human physiological system, known as humanized mice, are supposed to make extrapolation more reliable by simulating a variety of human diseases. But what justifies our belief that these mice are similar enough to their human counterparts to (...) simulate human disease? I argue that, unless three requirements are met in the process of humanizing mice, very little does. My requirements are not meant to provide necessary and sufficient conditions that guarantee a particular outcome. Instead, they serve as a heuristic for guiding scientific judgments involving extrapolation. In developing each requirement, I engage with philosophical issues concerning the nature of model-based science and the mechanistic approach (and its limits) to making generalizations in the life sciences. (shrink)

Within this paper, I critique the history of the modification of the broiler chicken through selective breeding and possible future genetic modification. I utilize Margaret Atwood’s fictitious depiction of genetically engineered chickens, from her novel Oryx and Crake , in order to forward the argument that modifications that eliminate animal telos either move beyond the range of current ethical frameworks or can be ethically defended by them. I then utilize the work of feminist epistemologists to argue that understanding what it (...) means to be a chicken shapes our conceptions of what modifications are or are not acceptable. Taking into account justifications stemming from practical knowledge when making ontological claims can help to shift our understanding of what animal modifications can or cannot be justified. The paper ends by addressing three possible problems brought about by accepting such justifications. (shrink)

It is one of the central aims of the philosophy of science to elucidate the meanings of scientific terms and also to think critically about their application. The focus of this essay is the scientific term predict and whether there is credible evidence that animal models, especially in toxicology and pathophysiology, can be used to predict human outcomes. Whether animals can be used to predict human response to drugs and other chemicals is apparently a contentious issue. However, when one empirically (...) analyzes animal models using scientific tools they fall far short of being able to predict human responses. This is not surprising considering what we have learned from fields such evolutionary and developmental biology, gene regulation and expression, epigenetics, complexity theory, and comparative genomics. (shrink)

BackgroundCurrent policies regulating the use of animals for scientific purposes are based on balancing between potential gain of knowledge and suffering of animals used in experimentation. The balancing process is complicated, on the one hand by plurality of views on our duties towards animals, and on the other hand by more recent discussions on uncertainty in the probability of reaching the final aim of the research and problems of translational failure.MethodsThe study combines ethical analysis based on a literature review with (...) neuropsychiatry-related preclinical research as a case study.ResultsBased on the analysis and the case study we show that neuropsychiatry-related preclinical research is an especially interesting case from an ethical perspective. The 3R principles are used to minimize the negative consequences for the animals used in research. However, neuropsychiatric research is characterized by specific challenges in assessing the probability of success of reaching the final aim, due to our limited mechanistic knowledge of human neuropsychiatric illness. Consequently, the translational value of the currently used animal models may be difficult to prove, which undermines the validity of these models and complicated the ethical assessment.ConclusionsWe conclude that a combined approach that deals with both science and the ethical dimensions is necessary to address the problems of validity and translation in neuropsychiatry-related preclinical research. We suggest this approach to comprise first, improved experimental methods, e.g. by using systematic reviews, second, a more patients-based approach that leads to models that reflect interindividual variation better, and third, more interdisciplinary cooperation. (shrink)

Inconsistencies in science take several forms. Some occur at the level of substantive claims about the world. Others occur at the level of methodology, and take the form of dilemmas, or cases of conflicting epistemic or cognitive values. In this article, I discuss how methodological dilemmas arise. I then consider how scientists resolve them. There are strong grounds for thinking that emotional judgement plays an important role in resolving methodological dilemmas. Lastly, I discuss whether and under what conditions this reliance (...) on emotional judgement is rationally warranted. I consider two possible mechanisms, based on coherence and induction, able to ensure that scientists’ emotional responses to methodological dilemmas are rationally warranted. (shrink)

I consider recent strategies proposed by econometricians for extrapolating causal effects from experimental to target populations. I argue that these strategies fall prey to the extrapolator’s circle: they require so much knowledge about the target population that the causal effects to be extrapolated can be identified from information about the target alone. I then consider comparative process tracing as a potential remedy. Although specifically designed to evade the extrapolator’s circle, I argue that CPT is unlikely to facilitate extrapolation in typical (...) econometrics and evidence-based policy applications. To argue this, I offer a distinction between two kinds of extrapolation, attributive and predictive, the latter being prevalent in econometrics and evidence-based policy. I argue that CPT is not helpful for predictive extrapolation when using the kinds of evidence that econometricians and evidence-based policy researchers prefer. I suggest that econometricians may need to consider qualitative evidence to overcome this problem. (shrink)

We argue that the recommendations made by the Institute of Medicine’s 2011 report, Chimpanzees in Biomedical and Behavioral Research : Assessing the Necessity, are methodologically and ethically confused. We argue that a proper understanding of evolution and complexity theory in terms of the science and ethics of using chimpanzees in biomedical research would have had led the committee to recommend not merely limiting but eliminating the use of chimpanzees in biomedical research. Specifically, we argue that a proper understanding of the (...) difference between the gross level of examination of species and examinations on finer levels can shed light on important methodological and ethical inconsistencies leading to ignorance of potentially unethical practices and policies regarding the use of animals in scientific research. (shrink)

Dear Editor,The April 2014 issue of Theoretical Medicine and Bioethics [1] presented eight essays regarding the use of nonhuman animals in biomedical research. While I appreciate the essays concerning contemporary research—which were well written and offered new thinking from the fields of ethics and ethology—I believe the journal, via the topics and the authors chosen, failed to communicate the most important fact regarding the current science pertinent to the use of nonhuman animals in research.The foundational reason for using chimpanzees and (...) other animals in research is their predictive value for human response to drugs and disease. This was alluded to by several of the authors when they discussed the necessity of using nonhuman animals. For example, Smith writes: “A common assumption in the selection of nonhuman animal subjects for research and the approval of research is that, if the risks of a procedure are too great for humans, and if there is a so-called scientific necessity, .. (shrink)

The ways in which other animal species can be informative about human biology are not exhausted by the traditional picture of the animal model. In this paper, I propose to distinguish two roles which laboratory organisms can have in biomedical research. In the more traditional case, organisms act as surrogates for human beings, and as such are expected to be more manageable replicas of humans. However, animal models can inform us about human biology in a much less straightforward way, by (...) being used as measuring devices—what I call their instrumental role. I first characterize this role and provide criteria for it, before illustrating it with some examples from biomedical research, especially cancer research. In such an instrumental role, phenotypes are not expected to phenocopy human phenomena, but instead have the purely instrumental value of detecting or measuring differences. I argue that the instrumental role is more prevalent than might first be suspected, and that some characteristics of contemporary biomedical research are increasingly shifting the use of laboratory organisms to the instrumental role. Finally, in light of the distinction proposed, I discuss the meaning of the expression “animal model”. (shrink)

Animal ethics committees (AECs) appeal to utilitarian principles in their justification of animal experiments. Although AECs do not grant rights to animals, they do accept that animals have moral standing and should not be unnecessarily harmed. Although many appeal to utilitarian arguments in the justification of animal experiments, I argue that AECs routinely fall short of the requirements needed for such justification in a variety of ways. I argue that taking the moral status of animals seriously—even if this falls short (...) of granting rights to animals—should lead to a thorough revision or complete elimination of many of the current practices in animal experimentation. (shrink)

The time is ripe for a greater interrogation of assumptions and commitments underlying an emerging common ground on the ethics of animal research as well on the 3 R (replacement, refinement, reduction) approach that parallels, and perhaps even further shapes, it. Recurring pressures to re-evaluate the moral status of some animals in research comes as much from within the relevant sciences as without. It seems incredible, in the light of what we now know of such animals as chimpanzees, to deny (...) that these animals are properly accorded high moral status. Barring the requirement that they be human, it is difficult to see what more animals such as chimpanzees would have to possess to acquire it. If the grounds for ascribing high moral status are to be non-arbitrary and responsive to our best knowledge of those individuals who possess the relevant features, we should expect that a sound ethical experimental science will periodically reassess the moral status of their research subjects as the relevant knowledge demands. We already can observe this reassessment as scientists committed to humane experimental science incorporate discoveries of enrichment tools and techniques into their housing and use of captive research animals. No less should this reassessment include a critical reflection on the possible elevation of moral status of certain research animals in light of what is discovered regarding their morally significant properties, characteristics or capacities, or so I will argue. To do anything short of this threatens the social and moral legitimacy of animal research. (shrink)

Public policymakers and institutional decision-makers routinely face questions about whether interventions “work”: does universal basic income improve people’s welfare and stimulate entrepreneurial activity? Do gated alleyways reduce burglaries or merely shift the crime burden to neighbouring communities? What is the most cost-effective way to improve students’ reading abilities? These are empirical questions that seem best answered by looking at the world, rather than trusting speculations about what will be effective. Evidence-based policy (EBP) is a movement that concretizes this intuition. It (...) maintains that policy should be based on evidence of “what works.” Not any evidence will do, however. Following on the heels of its intellectual progenitor, evidence-based medicine (EBM), EBP insists on the use of high-quality evidence produced in accordance with rigorous methodological standards. Though intuitively compelling, EBP has attracted significant criticism from methodologists, political scientists, and philosophers. This chapter provides a critical overview of EBP through a philosophical lens, reviewing and discussing some of the most pressing challenges that EBP faces and outlining some proposals for improving it. I first provide a brief overview of EBP and distinguish a broader and narrower understanding of it. I then review existing lines of criticism of EBP, two of which are considered in detail. The first elaborates how EBP struggles with extrapolation, that is, the use of evidence from study populations to make inferences about the effects of policies on novel target populations. The second maintains that EBP’s methodological tenets are deeply entwined with moral and political values, which can threaten EBP’s promise to promote objectivity in policymaking. Finally, I make some proposals for how EBP could be improved going forward. (shrink)

This chapter provides an introduction to the study of the philosophical notions of mechanisms and causality in biology and economics. This chapter sets the stage for this volume, Mechanism and Causality in Biology and Economics, in three ways. First, it gives a broad review of the recent changes and current state of the study of mechanisms and causality in the philosophy of science. Second, consistent with a recent trend in the philosophy of science to focus on scientific practices, it in (...) turn implies the importance of studying the scientific methods employed by researchers. Finally, by way of providing an overview of each chapter in the volume, this chapter demonstrates that biology and economics are two fertile fields for the philosophy of science and shows how biological and economic mechanisms and causality can be synthesized. (shrink)