Amending and Defending Critical Contextual Empiricism: Lessons from Medical Research

Amending and Defending Critical Contextual Empiricism: Lessons from Medical Research In Science as Social Knowledge (1990) and The Fate of Knowledge (2002), Helen Longino develops a social epistemological theory known as Critical Contextual Empiricism (CCE). While Longino’s work has been generally well-received, there have been a number of criticisms of CCE raised in the philosophical literature in recent years. In this paper I outline the key elements of Longino’s theory and propose several modifications to the four norms offered by the account. The revisions I propose are shaped by a number of developments in the medical context in recent years. The modified norms, which determined whether a particular community produces objective knowledge, are thus: 1. Avenues for Criticism – there must be recognized avenues for criticism, and these avenues must be publicly accessible and require transparent disclosure of all relevant information (including competing interests) from those who present their ideas. It must also be a community requirement that all members present their ideas for critical scrutiny if they wish them to be recognized as knowledge. 2. Responsiveness to Criticism – the community must be responsive to criticism. 3. Shared Public Standards – there must be some shared standards that determine community membership. Outsiders to a particular community are welcome to engage in critical debates as long as they share at least one of the community standards with the target community. 4. Cultivation of Diverse Perspectives – communities must cultivate diverse perspectives, that is, the perspectives of those who express strong dissent. The version of CCE I defend gives the principle of diversity a more central role than the original and provides greater specification of two of the other norms in light of challenges faced by medical researchers in recent years. The medical context provides us with a number of cautionary tales in which knowledge production that appears to meet the original four norms has been seriously compromised by particular social interests. The proposed modifications attempt to address these ‘loopholes’ in a way that is not ad hoc. I argue that the modifications I suggest are in line with the underlying assumptions and goals of CCE. The modified version of CCE also offers resources for defending CCE against the criticisms leveled against it by Miriam Solomon & Alan Richardson, Alvin Goldman and Philip Kitcher as well as one general concern arising out of a recent work by David Michaels. I provide responses to these criticisms in the final section of the paper. Throughout the paper I connect the theoretical work done in social epistemology to the real practice of knowledge-production as is occurs in the medical context. In light of the variety of social pressures influencing contemporary scientific research, and the role of science in shaping public policy, I argue that a rigorous social epistemology such as CCE is indispensable for understanding and assessing contemporary scientific practice

Improving the social value of clinical research

This presentation is part of the Social Values in Medical Research track. “Most therapeutic trials are inadequately formulated, and this from the earliest stages of their conception”: in a landmark article published in 1967, statisticians Daniel Schwartz and Joseph Lellouch made this remarkable claim. They based their argument on a now-familiar distinction between explanatory and pragmatic clinical trials. Explanatory trials investigate hypotheses under ideal conditions while pragmatic trials investigate hypotheses under usual, or “real-world”, conditions. They suggested that medical researchers at the time were making two common errors. The first was that they believed they were conducting pragmatic trials when they were really conducting explanatory trials, and the second was that they failed to provide adequate ethical justification for the explanatory trials they ended up conducting. One might be forgiven for thinking that while the inadequate formulation of therapeutic trials was a problem when Schwartz and Lellouch were writing in 1967—still the early years of clinical trials, relatively speaking—a more informed approach to the planning and design of trials prevails today. Unfortunately, this does not appear to be the case. The May, 2009 issue of the Journal of Clinical Epidemiology reprinted the famous article by Schwartz and Lellouch and contained a series of six back-and-forth response papers by two groups of highly respected clinical researchers, each of whom assessed the applicability of the historical argument to contemporary clinical research. Both groups agreed that researchers continue to make the same mistakes in the design of clinical trials that they made four decades ago. Consider, for instance, eligibility criteria for trial participants, which is one of the factors determining the classification of a particular trial on the explanatory/pragmatic continuum. In 2007, Harriette Van Spall and colleagues conducted a systematic sampling review to determine the nature and extent of exclusion criteria in RCTs published in the top medical journals. On the basis of their analysis of articles published between 1994-2006 in the top nine medical journals, Van Spall and colleagues concluded that “RCTs published in major medical journals may exclude both large segments of the general population and also specific patient populations from the benefits of participation in clinical investigations.” For example, they found exclusions on the basis of age in 72.1% of the RCTs, sex or sex-related conditions (including pregnancy, lack of contraception and menopausal status) in 39.2% and co-morbidities in 81.3%. A significant majority of trials (84.1%) contained at least one exclusion criterion judged by the reviewers to be poorly justified. This trend toward more exclusionary explanatory trials is more than simply odd, however; it is potentially harmful. In a widely cited article, Emanuel, Wendler and Grady identify seven requirements that must be met in order for clinical research on human subjects to be ethical. According to this account, the first question that should be asked during the ethical review of proposed research is whether the trial is socially valuable. The way this criterion is typically understood, a study investigating a “trivial” or “uninteresting” question, or that overlaps with already established research, is unethical because it does not promise any benefit, either to the subjects of the trial or to the general population. Principles of distributive justice, which raise concerns about appropriate use of social resources, support this criterion since wasteful spending has opportunity costs. Principles of social justice, which raise concerns about the inappropriate privileging of research that advances the interests of powerful social groups while neglecting others, also provide support for this criterion. This is because the requirement aims to protect the public good against, for instance, the good defined by powerful interests. With this framework in mind, it is worth considering whether a general assessment might be made about the relative value of explanatory and pragmatic trials. Explanatory trials appear to investigate questions that are of indirect social value, since they don’t tend to yield results that are immediately applicable in clinical practice. Pragmatic trials have direct social value, by contrast, and so are more likely to be immediately applicable to practice. In this paper I argue that even if it isn’t the case that explanatory trials are uniformly unjustified (since they may have some, albeit indirect, social value), it may frequently be the case that pragmatic trials would be better justified than explanatory trials. In many cases, pragmatic trials would better fulfill the ethical requirement for socially valuable clinical research. Further, we may have reason to pursue the most valuable research rather than minimally valuable research because of necessary limitations in research resources, including a global shortage of research subjects. One of the implications of this argument is that a burden of justification exists for those who would add restrictions to trials. Researchers should begin from the assumption that their trial will be designed to answer a practical question and enable decision-making in a particular context and then justify any idealizing elements added to the trial design. Greater reflection on the purpose of medical research is not just a matter for the ethics police in the form of various research ethics boards, funders, and other regulators, though some responsibilities certainly fall to these groups. Reflection on the purpose of research is part of the responsibility of the researchers themselves. Researchers need to be educated about the different purposes trials can serve so they can be in a position to provide justifications for their choice of research methods. Discussions about social value should be the starting point for clinical research

Valuing and Evaluating Evidence in Medicine

Medical decisions should be based on good evidence. But this does not mean that health care professionals should practice evidence-based medicine. This dissertation explores how these two positions come apart, why they come apart, and what we should do about it. I begin by answering the descriptive question, what are current standards of evidence in medicine? I then provide a detailed critique of these standards. Finally, I address the more difficult normative question, how should we determine standards of evidence in medicine? In medicine, standards of evidence have been established by the pervasive evidence-based medicine (EBM) movement. Until now, these standards have not been subjected to comprehensive philosophical scrutiny. I outline and defend a theory of knowledge – a version of Helen Longino’s Critical Contextual Empiricism (CCE) – which enables me to critically evaluate EBM. My version of CCE emphasizes the critical evaluation of background assumptions. In accordance with this, I identify and critically evaluate the three substantive assumptions underlying EBM. First, I argue that medicine should not be held to the restrictive definition of science assumed by proponents of EBM. Second, I argue that epidemiological evidence should not be the only “base” of medical decisions. Third, I argue that not only is the particular hierarchy of evidence assumed by EBM unjustified, but that any attempt to hierarchically rank research methods is incoherent and unjustifiably restricts medical knowledge. Current standards of evidence divert attention from many legitimate sources of evidence. This distorts medical research and practice. In the remainder of the dissertation I propose means for improving not only current standards of medical evidence but also the process of producing and defending future standards. On the basis of four CCE norms, I argue that we have reason to protect and promote those features of the medical community that facilitate diversity, transparency, and critical interaction. Only then can we ensure that the medical community retains its ability to produce evidence that is both rigorous and relevant to practice.Ph