Why do classic biostatistical studies, alleged to provide causal explanations of effects, often fail? This article argues that in statistics-relevant areas of biology—such as epidemiology, population biology, toxicology, and vector ecology—scientists often misunderstand epistemic constraints on use of the statistical-significance rule (SSR). As a result, biologists often make faulty causal inferences. The paper (1) provides several examples of faulty causal inferences that rely on tests of statistical significance; (2) uncovers the flawed theoretical assumptions, especially those related to randomization, that likely (...) contribute to flawed biostatistics; (3) re-assesses the three classic (SSR-warrant, avoiding-selection-bias, and avoiding-confounders) arguments for using SSR only with randomization; and (4) offers five new reasons for biologists to use SSR only with randomized experiments. (shrink)

While their strength, electrical, optical, or magnetic properties are expected to contribute a trillion dollars in global commerce before 2015, nanomaterials also appear to pose threats to human health and safety. Nanotoxicology is the study of these threats. Do nanomaterial benefits exceed their risks? Should all nanomaterials be regulated? Currently nanotoxicologists cannot help answer these questions because too little is known about nanomaterials, because their properties differ from those of bulk materials having the same chemical composition, and because they differ (...) so widely in their applications. Instead, this paper answers a preliminary ethical question: What nanotech policies are likely to contribute to society’s ability to give or withhold free informed consent to the potential risks associated with production and use of nanomaterials? This paper argues that at least four current policies appear to jeopardize the risk-disclosure condition that is required for informed consent. These are the funding problem, the conflict-of-interest problem, the labeling problem, and the extrapolation problem. Apart from future decisions on how to ethically make, use, and regulate nanomaterials, this paper argues that, at a minimum, these four policies must be modified. Government must spend greater monies on nanotoxicology; ensure independent nanotoxicology research; label consumer products containing nanomaterials; and avoid assuming that nanotoxicological properties are based merely on mass and chemical composition. Otherwise free informed consent to these new technologies and materials may be jeopardized. (shrink)

One way to do socially relevant investigations of science is through conceptual analysis of scientific terms used in special-interest science (SIS). SIS is science having welfare-related consequences and funded by special interests, e.g., tobacco companies, in order to establish predetermined conclusions. For instance, because the chemical industry seeks deregulation of toxic emissions and avoiding costly cleanups, it funds SIS that supports the concept of "hormesis" (according to which low doses of toxins/carcinogens have beneficial effects). Analyzing the hormesis concept of its (...) main defender, chemical-industry-funded Edward Calabrese, the paper shows Calabrese and others fail to distinguish three different hormesis concepts, H, HG, and HD. H requires toxin-induced, short-term beneficial effects for only one biological endpoint, while HG requires toxin-induced, net-beneficial effects for all endpoints/responses/subjects/ages/conditions. HD requires using the risk-assessment/regulatory default rule that all low-dose toxic exposures are net-beneficial, thus allowable. Clarifying these concepts, the paper argues for five main claims. (1) Claims positing H are trivially true but irrelevant to regulations. (2) Claims positing HG are relevant to regulation but scientifically false. (3) Claims positing HD are relevant to regulation but ethically/scientifically questionable. (4) Although no hormesis concept (H, HG, or HD) has both scientific validity and regulatory relevance, Calabrese and others obscure this fact through repeated equivocation, begging the question, and data-tri mm ing. Consequently (5) their errors provide some undeserved rhetorical plausibility for deregulating low-dose toxins. (shrink)

This paper explores how law might conceive of the injury or harm of endocrine disruption as it applies to an aboriginal community experiencing chronic chemical pollution. The effect of the pollution in this case is not only gendered, but gendering: it seems to be causing the ‘production’ of two girl babies for every boy born on the reserve. This presents an opening to interrogate how law is implicated in the constitution of not just gender but sex. The analysis takes an (...) embodied turn, attempting to validate the real and material consequences of synthetic chemicals acting on bodies—but uncovers that finding a harm in a declining sex ratio depends on a static conception of the human form, based on unfounded assumptions of ‘naturalness’ and ‘normalcy’. Elizabeth Grosz’s theory of ‘becoming’ offers a compelling challenge, essentially pointing to the conclusion that we should find harm where we find illness and suffering and not simply where we find difference. At the same time, we cannot discount the political economy of the pollution: the paper concludes by returning the focus to the role of power, colonialism and the state in the perpetuation of the pollution on the landscape. (shrink)

Various U.S. laws, such as the Clean Air Act and the Food Quality Protection Act, require additional protections for susceptible subpopulations who face greater environmental health risks. The main ethical rationale for providing these protections is to ensure that environmental health risks are distributed fairly. In this article, we (1) consider how several influential theories of justice deal with issues related to the distribution of environmental health risks; (2) show that these theories often fail to provide specific guidance concerning policy (...) choices; and (3) argue that an approach to public decision making known as accountability for reasonableness can complement theories of justice in establishing acceptable environmental health risks for the general population and susceptible subpopulations. Since accountability for reasonableness focuses on the fairness of the decision-making process, not the outcome, it does not guarantee that susceptible subpopulations will receive a maximum level of protection, regardless of costs or other morally relevant considerations. (shrink)

The relevance of scientific knowledge for science and technology policy and regulation has led to a growing debate about the role of values. This article contributes to the clarification of what specific functions cognitive and noncognitive values adopt in knowledge generation and decisions, and what consequences the operation of values has for policy making and regulation. For our analysis, we differentiate between three different types of decision approaches, each of which shows a particular constellation of cognitive and noncognitive values. Our (...) objectives are to present a structured analysis of the varying functions that different kinds of values can adopt, as well as the value-related tensions and trade-offs they give rise to. We argue that the operation of noncognitive values in scientific knowledge generation, policy, and regulatory decision making can be understood as an enabling factor, rather than a limiting one. (shrink)

This paper examines how ethically significant assumptions and values are embedded not only in environmental policies but also in the language of the environmental sciences. It shows, based on three case studies associated with contemporary pollution research, how the choice of scientific categories and terms can have at least four ethically significant effects: influencing the future course of scientific research; altering public awareness or attention to environmental phenomena; affecting the attitudes or behavior of key decision makers; and changing the burdens (...) of proof required for taking action in response to environmental concerns. The paper argues that deliberative forums, research-ethics training, and conceptual work by environmental philosophers could all promote more ethically sensitive responses to these features of scientific language. (shrink)

. The potential for financial conflicts of interest to influence scientific research has become a significant concern. Some commentators have suggested that the development of standardized study protocols could help to alleviate these problems. This paper identifies two problems with this solution: scientific research incorporates numerous methodological judgments that cannot be constrained by standardized protocols; and standardization can hide significant value judgments. These problems arise because of four weaknesses of standardized guidelines: incompleteness, limited applicability, selective ignorance, and ossification. Therefore, the (...) standardization of study designs should not serve as an alternative to addressing the interests and power relations that pervade science policy-making. Policy makers should take at least two steps to prevent powerful interest groups from co-opting standardized guidelines. First, their development and review should be made as transparent as possible and should be subjected to broadly-based deliberation. Second, standardized guidelines should be supplemented with efforts to scrutinize the conditions under which financial COIs tend to have the most worrisome effects so that additional steps can be taken to eliminate and mitigate those conditions. (shrink)

The potential for financial conflicts of interest (COIs) to damage the credibility of scientific research has become a significant social concern, especially in the wake of high-profile incidents involving the pharmaceutical, tobacco, fossil-fuel, and chemical industries. Scientists and policy makers have debated whether the presence of financial COIs should count as a reason for treating research with suspicion or whether research should instead be evaluated solely based on its scientific quality. This paper examines a recent proposal to develop criteria for (...) evaluating the credibility of research without considering its source of funding. It concludes that proposals of this sort are likely to be either ineffective or impractical in many cases. Nevertheless, this does not imply that all research funded by those with an interest in the outcome must be placed under a cloud of suspicion; there are conditions under which research is at much more serious risk of being corrupted than in other cases, and attention to these conditions can guide productive responses to financial COIs. (shrink)

Cancer—and scientific research on cancer—raises a variety of compelling philosophical questions. This entry will focus on four topics, which philosophers of science have begun to explore and debate. First, scientific classifications of cancer have as yet failed to yield a unified taxonomy. There is a diversity of classificatory schemes for cancer, and while some are hierarchical, others appear to be “cross-cutting,” or non-nested. This literature thus raises a variety of questions about the nature of the disease and disease classification. Second, (...) philosophers of science have historically taken the aim of science to be arriving at true theories. However, scientists studying cancer come from a variety of disciplines, with different scientific as well as practical aims. Perhaps it is not surprising, then, that historians and philosophers of science do not seem to agree on how best to characterize the aim and structure of cancer research; it is far from clear whether the appropriate characterization of the aim is arriving at true theories, or even whether the proper units of analysis are “theories”, or instead, “models”, “explanatory frameworks”, “research programs”, “paradigms”, or perhaps, “experimental traditions”. With the rise of “big data” science—such as the Cancer Genome Atlas Project (or TCGA)—and “systems” approaches to the study of disease, both philosophers and historians of science are rethinking how best to describe and explain these distinctive kinds of scientific inquiry. -/- Third, cancer is in part a byproduct of our developmental and life history, as well as our evolutionary history. Cancer progression can be compared to a reversion of development, or, to the evolution of multicellularity. Thus, cancer raises intriguing questions about how we conceive of “functions”, “development”, and the role of our evolutionary history and particularly, selective trade-offs, in vulnerability to disease. -/- Last but not least, cancer research provides a case study for consideration of the roles of values at the science-policy interface. Epidemiological and toxicological research on cancer’s causes informs toxics law and regulatory policy, which raises a variety of questions about the nature of evidence and inductive risk in such contexts. (shrink)