Christopher Boorse’s biostatistical theory of medical disorder claims that biological part-dysfunction (i.e., failure of an internal mechanism to perform its biological function), a factual criterion, is both necessary and sufficient for disorder. Jerome Wakefield’s harmful dysfunction analysis of medical disorder agrees that part-dysfunction is necessary but rejects the sufficiency claim, maintaining that disorder also requires that the part-dysfunction causes harm to the individual, a value criterion. In this paper, I present two considerations against the sufficiency claim. First, I analyze Boorse’s (...) central argument for the sufficiency claim, the “pathologist argument,” which takes pathologists’ intuitions about pathology as determinative of medical disorder and conclude that it begs the question and fails to support the sufficiency claim. Second, I present four counterexamples from the medical literature in which salient part-dysfunctions are considered nondisorders, including healthy disease carriers, HIV-positive status, benign mutations, and situs inversus totalis, thus falsifying the sufficiency claim and supporting the harm criterion. (shrink)

It is human nature to try to recognize patterns and to make sense of that which we observe. Unfortunately, our intuition is often wrong, and so there is a need to impose some objectivity on the methods by which observations are converted into knowledge. One definition of biostatistics could be precisely this, the rigorous and objective conversion of medical and/or biological observations into knowledge. Both consumers of biostatistical principles and biostatisticians themselves vary in the extent to which they recognize (...) the need to continue the improvement. Some may not recognize the need for (some or all of) the methods that have already been developed; others may accept these as they find them completely sufficient; still others recognize both the value and the shortcomings of these methods, and seek to develop even better methods to ensure that future medical conclusions are less subject to biases than current ones are. (shrink)

Similarly to other accounts of disease, Christopher Boorse’s Biostatistical Theory (BST) is generally presented and considered as conceptual analysis, that is, as making claims about the meaning of currently used concepts. But conceptual analysis has been convincingly critiqued as relying on problematic assumptions about the existence, meaning, and use of concepts. Because of these problems, accounts of disease and health should be evaluated not as claims about current meaning, I argue, but instead as proposals about how to define and use (...) these terms in the future, a methodology suggested by Quine and Carnap. I begin this article by describing problems with conceptual analysis and advantages of “philosophical explication,” my favored approach. I then describe two attacks on the BST that also question the entire project of defining “disease.” Finally, I defend the BST as a philosophical explication by showing how it could define useful terms for medical science and ethics. (shrink)

This essay replies to critics since 1995 of my “biostatistical theory” of health. According to the BST, a pathological condition is a state of statistically species-subnormal biological part-functional ability, relative to sex and age. Theoretical health, the total absence of pathological conditions, is then a value-free scientific notion. Recent critics offer a mixture of old and new objections to this analysis. Some new ones relate to choice of reference class, situation-specificity of function, common diseases and healthy populations, improvements in population (...) health, the practice of pathologists, “Cambridge changes” in health status, and comparative vs. absolute health concepts. I make no changes in doctrine, except to consider treating “normal aging” as pathological by taking young adults as the standard for all adults. (shrink)

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)

Fundamental properties of N-valued logics are compared and eleven theorems are presented for their Logic Algebras, including Łukasiewicz–Moisil Logic Algebras represented in terms of categories and functors. For example, the Fundamental Logic Adjunction Theorem allows one to transfer certain universal, or global, properties of the Category of Boolean Algebras,, (which are well-understood) to the more general category \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\cal L}$$\end{document}Mn of Łukasiewicz–Moisil Algebras. Furthermore, the relationships of LMn-algebras to other many-valued logical structures, (...) such as the n-valued Post, MV and Heyting logic algebras, are investigated and several pertinent theorems are derived. Applications of Łukasiewicz–Moisil Algebras to biological problems, such as nonlinear dynamics of genetic networks – that were previously reported – are also briefly noted here, and finally, probabilities are precisely defined over LMn-algebras with an eye to immediate, possible applications in biostatistics. (shrink)

Contemporary philosophy of health has been quite focused on the problem of determining the nature of the concepts of health, illness and disease from a scientific point of view. Some theorists claim and argue that these concepts are value-free and descriptive in the same sense as the concepts of atom, metal and rain are value-free and descriptive. To say that a person has a certain disease or that he or she is unhealthy is thus to objectively describe this person. On (...) the other hand it certainly does not preclude an additional evaluation of the state of affairs as undesirable or bad. The basic scientific description and the evaluation are, however, two independent matters, according to this kind of theory. Other philosophers claim that the concept of health, together with the other medical concepts, is essentially value-laden. To establish that a person is healthy does not just entail some objective inspection and measurement. It presupposes also an evaluation of the general state of the person. A statement that he or she is healthy does not merely imply certain scientific facts regarding the person’s body or mind but implies also a (positive) evaluation of the person’s bodily and mental state. My task in this paper will be, first, to present the two principal rival types of theories and present what I take to be the main kind of reasoning by which we could assess these theories, and second, to present a deeper characterization of the principal rival theories of health and illness. (shrink)

Boorse’s biostatistical theory states that diseases should be defined in ways that reflect disturbances of biological function and that are objective and value free. We use three examples from contemporary medicine that demonstrate the complex issues that arise when defining the boundaries of disease: polycystic ovary syndrome, chronic kidney disease, and myocardial infarction. We argue that the biostatistical theory fails to provide sufficient guidance on where the boundaries of disease should be drawn, contains ambiguities relating to choice of reference class, (...) and is out of step with medical processes for identifying disease boundaries. Although proponents of the biostatistical theory might regard these practical issues as irrelevant to the aim of providing a theoretical account of disease, we take them to indicate the need for a theoretical account that is adequate for current needs—including limiting new forms of medicalization that are driven by the identification of disease based on dysfunction. Our processes for determining the boundaries for disease need to recognize that there is no value-free method for making these decisions. (shrink)

Antoine C. Dussault Cet article renforce l’objection des dysfonctions bénignes soulevée par Jerome Wakefield contre la théorie biostatistique de Christopher Boorse, en en présentant une version qui prend acte d’une critique importante de l’analyse conceptuelle comme visée pour une théorie de la santé et de la pathologie. Cette objection prend pour cible la considération, par la théorie de Boorse, que la dysfonction de la partie d’un organisme est suffisante pour la pathologie de cet organisme. Situant sa critique dans le cadre (...) méthodologique de l’analyse conceptuelle, Wakefield soutient que cet aspect de la théorie de Boorse pose problème au regard des dysfonctions qui, parce qu’elles sont bénignes, ne sont pas considérées comme pathologiques par la médecine. Je présente une version de l’objection des dysfonctions bénignes intégrant les apports méthodologiques de l’explication philosophique telle que caractérisée par Peter Schwartz. Je fais valoir que sa considération des dysfonctions bénignes comme pathologiques fait échouer la théorie de Boorse à rendre compte de la portée pratique qu’ont les concepts de santé et de pathologie dans la médecine occidentale. (shrink)

Christopher Boorse’s Biostatistical Theory of Health has been the main contender among naturalistic accounts of health for the last 40 years. Yet, a recent criticism of this theory, presented by Elselijn Kingma, identifies a dilemma resulting from the BST’s conceptual linking of health and statistical typicality. Kingma argues that the BST either cannot accommodate the situation- specificity of many normal functions or cannot account for many situation-specific diseases. In this article, we expand upon with Daniel Hausman’s response to Kingma’s dilemma. (...) We propose that recalling Boorse’s specification that health is an intrinsic property of its bearers and explicating this intrinsic property in relation to the concept of homeostasis can illuminate how proponents of naturalistic accounts of health should deal with the situation- specificity of normal functions. We argue that beyond what Boorse and Hausman have delineated, the situation- specificity of normal function cannot be fully captured in a simple dichotomy between normal and abnormal environment or between relevant and irrelevant situations. By bringing homeostasis to the fore of the analysis of health, we set out a richer picture of what the various situations that affect living organisms’ functional performance can be. Accordingly, we provide a broader classification of these various situations which, we contend, better accounts for the main intuitions that philosophers of medicine have sought to accommodate than previous naturalistic theories of health. (shrink)

Graphical AbstractThe ACcess to Transparent Statistics (ACTS) call to action assembles four measures that are rapidly achievable by journals and funding agencies to enhance the quality of statistical reporting. The ACTS call to action is an appeal for concrete actions from institutions that should spearhead the battle for reproducibility.

This is the first book on practical philosophy of science and how to practically evaluate scientific findings that have life-and-death consequences. Showing how to uncover scores of scientific flaws -- typically used by special interests who try to justify their deadly pollution -- this book aims to liberate the many potential victims of environmentally-induced disease and death.

Some ‘naturalist’ accounts of disease employ a biostatistical account of dysfunction, whilst others use a ‘selected effect’ account. Several recent authors have argued that the biostatistical account offers the best hope for a naturalist account of disease. We show that the selected effect account survives the criticisms levelled by these authors relatively unscathed, and has significant advantages over the BST. Moreover, unlike the BST, it has a strong theoretical rationale and can provide substantive reasons to decide difficult cases. This is (...) illustrated by showing how life-history theory clarifies the status of so-called diseases of old age. The selected effect account of function deserves a more prominent place in the philosophy of medicine than it currently occupies. _1_ Introduction _2_ Biostatistical and Selected Effect Accounts of Function _3_ Objections to the Selected Effect Account _3.1_ Boorse _3.2_ Kingma _3.3_ Hausman _3.4_ Murphy and Woolfolk _4_ Problems for the Biostatistical Account _4.1_ Schwartz _5_ Analysis versus Explication _6_ Explicating Dysfunction: Life History Theory and Senescence _7_ Conclusion. (shrink)

The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new (...) vision of care. Molecular tumor boards are one response to these changes and are now providing better access to next-generation sequencing and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent documents at all academic medical centers and to introduce dynamic and electronic informed consent. (shrink)

In, I argued that Boorse's biostatistical theory of health is unable to accommodate diseases that are the normal result of harmful environments. Hausman disagrees: if the BST compares normal dispositional function against the whole population or reference class, rather than against organisms in similar circumstances as I proposed, then my challenge can be avoided. In this paper, I argue that Hausman's response fails: his proposal cannot accommodate a series of common physiological processes, such as sleep and those involved in reproduction. (...) In the course of this argument, I also offer a detailed discussion of the concept of functional efficiency, and reveal a link between the problem of environments and that of reference classes. 1 Introduction2 Kingma on Boorse3 Hausman on Kingma4 Response to Hausman5 Three Possible Replies5.1 Reference classes5.2 Temporary pathologies5.3 Adequacy of function6 Concluding Discussion. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been inadequately (...) represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in ?consent bias.? As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent should be unnecessary. After (...) analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research. (shrink)

We sketch a novel and improved version of Boorse’s biostatistical theory of functions. Roughly, our theory maintains that (i) functions are non-negligible contributions to survival or inclusive fitness (when a trait contributes to survival or inclusive fitness); (ii) situations appropriate for the performance of a function are typical situations in which a trait contributes to survival or inclusive fitness; (iii) appropriate rates of functioning are rates that make adequate contributions to survival or inclusive fitness (in situations appropriate for the performance (...) of that function); and (iv) dysfunction is the inability to perform a function at an appropriate rate in appropriate situations. Based on our theory, we sketch solutions to three problems that have afflicted Boorse’s theory of function, namely, Kingma’s ([2010]) problem of the situation-specificity of functions, the problem of multi-functional traits, and the problem of how to distinguish between appropriate and inappropriate rates of functioning. (shrink)

In this short paper we analyse some paradoxical aspects of France’s Foucauldian heritage: while several French scholars claim the COVID-19 pandemic is a perfect example of what Foucault called biopolitics, popular reaction instead suggests a biopolitical failure on the part of the government; One of these failures concerns the government’s inability to produce reliable biostatistical data, especially regarding health inequalities in relation to COVID-19. We interrogate whether Foucaldianism contributed, in the past as well today, towards a certain myopia in France (...) regarding biostatistics and its relation to social inequalities in health. One might ask whether this very data could provide an appropriate response to the Foucauldian question: What kind of governance of life is the pandemic revealing to us? (shrink)

This essay develops an account of health, the functional efficiency theory, which derives from Christopher Boorse's biostatistical theory. Like the BST, the functional efficiency theory is a nonevaluative view of health, but unlike the BST, it argues that the fundamental theoretical task is to distinguish levels of efficiency with which the parts and processes within organisms and within systems within organisms function. Which of these to label as healthy or pathological is of secondary importance. Because the statistical distributions that Boorse's (...) account relies on are distributions of functional efficiency, the functional efficiency theory arguably complements rather than challenges the BST. (shrink)

This paper is a response to Christopher Boorse's recent defense of his Biostatistical Theory of health and disease. Boorse maintains that his concept of theoretical health and disease reflects the "considered usage of pathologists." I argue that pathologists do not use "disease" in the purely theoretical way that is required by the BST. Pathology does not draw a sharp distinction between theoretical and practical aspects of medicine.

There is a conceptual crisis in the biomedical sciences that is particularly salient in psychopathology research. Underlying the crisis is a controversy that pertains to the current medical model of disease that largely draws from causal-mechanistic explanations. The bedrock of this model is the analysis of biological part-dysfunctions that aims at unequivocally defining a pathological condition and demarcating it from its neighboring entities. This endeavor has led to a quest for physiological, biochemical, and genetic signatures. Yet, so far there is (...) little evidence for reliable biomarkers for any mental disorder. The contemporary biomedical paradigm largely ignores historical, dynamic, and system-level aspects—a view that has contributed much to the conceptual disjunction of the patient as a person from his/her disease. Notwithstanding the impressive progress in the biomedical sciences, increasingly more critics question whether the constituting framework is sufficient to convey a comprehensive understanding of illnesses, especially mental illnesses. Thus, the medical model urgently requires an update. But rather than revamping it by methodological advancements, it will be necessary to critically review its philosophical roots. The most problematic issues that require reworking are: the preponderance of the biostatistical theory; the undue decoupling of physiological from evolutionary explanations of function; the clinging to the Modern Synthesis ; and the neglect of dynamic and system-level properties. The proposed overhaul requires the heeding of historical explanations that draw from the Extended Evolutionary Synthesis as well as systems biology approaches for tackling multilevel and dynamic phenomena of complex systems. (shrink)

Due to several socio-political factors, to many psychiatrists only a strictly objective definition of mental disorder, free of value components, seems really acceptable. In this paper, I will explore a variant of such an objectivist approach to defining metal disorder, natural function objectivism. Proponents of this approach make recourse to the notion of natural function in order to reach a value-free definition of mental disorder. The exploration of Christopher Boorse's 'biostatistical' account of natural function (1) will be followed an investigation (...) of the 'hybrid naturalism' approach to natural functions by Jerome Wakefield (2). In the third part, I will explore two proposals that call into question the whole attempt to define mental disorder (3). I will conclude that while 'natural function objectivism' accounts fail to provide the backdrop for a reliable definition of mental disorder, there is no compelling reason to conclude that a definition cannot be achieved. (shrink)

What is considered normal determines clinical practice in medicine and has implications at an individual level, doctor-patient relationship and health care policies. With the increase in medical information and technical abilities it is urgent to have a clear concept of normality in medicine so that crucial discussions can be held with unequivocal terms.The different meanings for normality were analyzed throughout the literature and grouped according to their relevance in the academic community in models, namely the Biostatistical Theory (BST), Health, Ideal, (...) Process and Biological advantage. The BST is the most established naturalistic approach, however normal variability can arguably constitute a problem. Health is similar and raises the question of setting the boundaries of pathology. Normality as an Ideal is an useful tool but is naturally unrealistic. As a Process it is comprehensible but is hard to frame for practical purposes. If considered as a Biological Advantage, seems intuitive but abnormality should tend to disappear.After, three examples were presented to discuss these models. They were Anemia, Psychiatric diseases and Psychopathy. In the case of Anemia the BST was applied and the arbitrary boundaries but with social impact were exposed. Psychiatric diseases was discussed under the process of self-organization and non-suffering ideal. With Psychopathy the boundaries of biological advantage are questioned.This review appeals to the importance of redesigning of the concept of normality in medicine according to current times and stresses the importance of integrating concepts such as variability and autonomy. (shrink)

This essay argues that what is central to Christopher Boorse’s biostatistical theory of disease as statistically subnormal part function (BST) are comparisons of the “functional efficiency” of parts and processes and that statistical considerations serve only to pick out a healthy level of functional efficiency. On this interpretation, the distinction between health and pathology is less important than comparisons of functional efficiency, which are entirely independent of statistical considerations. The clarifications or revisions of the BST that this essay offers are (...) friendly amendments that render moot some of the most prominent criticisms of Boorse’s account. (shrink)

This paper examines the most influential naturalist theory of health, Christopher Boorse’s ‘biostatistical theory’ . I argue that the BST is an unsuitable candidate for the rôle that Boorse has cast it to play, namely, to underpin medicine with a theoretical, value-free science of health and disease. Following the literature, I distinguish between “real” changes and “mere Cambridge changes” in terms of the difference between an individual’s intrinsic and relational properties and argue that the framework of the BST essentially implies (...) a Cambridge-change criterion. The examination reveals that this implicit criterion commits the BST to the troubling view that an individual could go from being diseased to healthy, or vice versa, without any physiological change in that individual. Two problems follow: the current framework of the BST is ill-equipped to formally embrace Cambridge changes and it is theoretically dubious. The arguments advanced here are not limited to the BST; I suggest they extend to any naturalist claim to underpin medical practice with a value-free theory of health and disease defined in terms of an evolutionary view of biological fitness. (shrink)

Elselijn Kingma argues that Christopher Boorse’s biostatistical theory (the BST) does not show how the reference classes it uses are objective and naturalistic. Recently, philosophers of medicine have attempted to rebut Kingma’s concerns. I argue that these rebuttals are theoretically unconvincing, and that there are clear examples of physicians adjusting their reference classes according to their prior knowledge of health and disease. I focus on the use of age-adjusted reference classes to diagnose low bone mineral density in children. In addition (...) to using the BST’s age, sex, and species, physicians also choose to use other factors to define reference classes, such as pubertal status, bone age, body size, and muscle mass. I show that physicians calibrate the reference classes they use according to their prior knowledge of health and disease. Reference classes are also chosen for pragmatic reasons, such as to predict fragility fractures. (shrink)

There has been much debate about whether the concept of disease articulated in Boorse’s biostatistical theory is value-neutral or value-laden. Here, I want to examine whether this debate matters. I suggest that there are two basic respects in which value-ladenness might be important: it could threaten either scientific legitimacy or moral permissibility. I argue that value-ladenness does not threaten the scientific legitimacy of our disease-concept because the concept makes little difference to the formulation and testing of scientific hypotheses. Likewise, even (...) if our disease-concept is value-laden, this does not show it is morally impermissible. To determine its permissibility, we must regard it as a tool to structure social institutions. Seen in that way, whether our disease-concept is morally permissible is a consequentialist matter and depends exquisitely on unanswered empirical questions. (shrink)

Two decades ago, the eminent evolutionary biologist George C. Williams and his physician coauthor, Randolph Nesse, formulated the evolutionary medicine research program. Williams and Nesse explicitly made adaptationism a core component of the new program, which has served to undermine the program ever since, distorting its practitioners’ perceptions of evidentiary burdens and in extreme cases has served to warp practitioner’s understandings of the relationship between evolutionary benefits/detriments and medical ones. I show that the Williams and Nesse program more particularly embraces (...) the panselectionist variety of adaptationism (the empirical assumption that non-adaptive evolutionary processes are causally unimportant compared to natural selection), and argue that this has harmed the field. Panselectionism serves to conceal the enormous evidentiary hurdles that evolutionary medicine hypotheses face, making them appear stronger than they are. I use two examples of evolutionary medicine texts, on neonatal jaundice and on asthma, to show that some evolutionary medicine practitioners have allowed their fervent panselectionism to directly shape their recommendations for clinical practice. I argue that this escalation of panselectionism’s influence is inappropriate under Williams’ and Nesse original stated standards, despite being inspired by their program. I also show that the examples’ conflation of clinical and evolutionary considerations is inappropriate even under Christopher Boorse’s controversial evolution-rooted concepts of disease and health. (shrink)

The article examines the relationship between a trait’s effect on survival and reproduction and the notion of functional efficiency underlying the biostatistical theory of health. BST faces the problem of how to measure a trait’s joint effect on survival and reproduction in its account of function. If one measures the joint effect by means of the biological notion of fitness, examples such as the hereditary breast and ovarian cancer syndrome do not count as a disorder. If one does not invoke (...) biological fitness, it is unclear how to measure the joint effect while keeping to BST’s naturalist credentials. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Public Health Ethics: Health by the NumbersMartina Darragh (bio) and Pat Milmoe McCarrick (bio)Hippocrates had nothing to say about public health. Rather, the idea that a government should protect its citizens from disease by maintaining sanitary conditions has its origin in Renaissance humanities texts, and the notion that physicians have public health responsibilities emerged in the works of such Enlightenment authors as Johann Peter Frank, Benjamin Rush, and John (...) Gregory (II, Coughlin and Beauchamp 1996). When the spread of infectious diseases such as typhoid and cholera accompanied the growth of the Industrial Revolution, England was the first to respond by passing the Public Health Act of 1848. The motivation for this reform was not based in humanitarian concerns but in the realization that unsanitary conditions were costly to industry. “... [The] founders of the public health movement were guided by nineteenth century utilitarian moral theories... the greatest good for the greatest number... accompanied by a growing appreciation for the innate value and dignity of mankind... however, the rights and autonomy of individuals have not always been respected in pursuing these important objectives” (I, Coughlin 1995, p. 1).Public health projects have dramatically improved global health status. One measure of their success is that “... most poor people now live longer, on average, than the wealthiest people a century ago” (I, Beaglehole and Bonita 1997, p. 13) These projects are not limited to such activities as disinfecting sewers. “Public health is what we, as a society, do to collectively assure the conditions in which people can be healthy. This requires that continuing and emerging threats to the health of the public be successfully countered. These threats include immediate crises, such as the AIDS epidemic; enduring problems, such as injuries and chronic illness; and impending crises foreshadowed by such developments as the toxic by-products of a modern economy” (I, Institute of Medicine (IOM) 1988, p. 1) The practice of public health has embraced this IOM challenge and includes the subspecialties of epidemiology, health promotion and education, public health administration, international health, maternal and child health, biostatistics, environmental health, and nutrition. This annotated bibliography focuses on epidemiology, [End Page 339] health promotion and education, and public health administration, and includes a wide variety of opinions on each topic.EpidemiologyAt first glance, it is hard to see what ethical issues could arise in population studies of the causes and control of illness. Disclosure of risk information in the clinical encounter is complicated by issues of uncertainty with regard to the data itself. Causation and causal inference may be affected by “wish bias,” leading to studies that use the same data but reach widely varying conclusions (II, Weed 1997). Given the complexity of the statistical calculations used to validate public health recommendations, and mass media’s portrayal of them, the public may be unintentionally deceived by population-based recommendations (V, Seedhouse 1997; II, Lupton 1995). With the addition of genetic screening, another layer of statistical complexity is added to this mix (VI, Stone and Steward 1996).Health Promotion and EducationIncreased life expectancy brought about by advances in public health has raised a new set of problems. With the realization that illness can be promoted in part by individual life-style choices, population-based recommendations about risk factors become important in the clinical encounter. This shift is not without difficulties; one author notes that he has yet to receive any risk information from his physicians, even when he asks “the experts” (V, Dugdale 1998). This may be due in part to the fact that “... public health lacks a vocabulary with which to speak about and identify commonalities among health problems experienced by very different populations” (IV, Mann 1997, p. 8). Furthermore, the mix of disciplines informing health promotion activities (sociology, psychology, recreation medicine, and the like) creates an illusion of shared ethics where none exists, which in turn leads to programs based on value systems that may not be meaningful for the populations they serve (V, Seedhouse 1997).Given these factors, a number of authors are skeptical of introducing public health measures into the clinical encounter. “We might do well to encourage people to live lives of modified hedonism so that they might... (shrink)

I argue that ductal carcinoma in situ (DCIS), the tumor most commonly diagnosed by breast mammography, cannot be confidently classified as cancer, that is, as pathological. This is because there may not be dysfunction present in DCIS—as I argue based on its high prevalence and the small amount of risk it conveys—and thus DCIS may not count as a disease by dysfunction-requiring approaches, such as Boorse’s biostatistical theory and Wakefield’s harmful dysfunction account. Patients should decide about treatment for DCIS based (...) on the risks it poses and the risks and benefits of treatment, not on its disease status. (shrink)

What is it to have a mental disorder? The paper proposes an ability-based view of mental disorder. It argues that such a view is preferable to biological dysfunction views such as Wakefield’s Harmful Dysfunction Analysis and Boorse’s Biostatistical Theory. According to the proposed view, having a mental disorder is basically a matter of having a certain type of inability (or: an ability that is not sufficiently high): the inability to respond adequately to some of one’s available reasons in some of (...) one’s reasons-sensitive attitudes or actions, where the threshold of inability is determined by one’s being harmed. The relevant concepts of inability, reasons, and harm are sketched. The paper argues that the proposed view evades some problems of biological dysfunction views by remaining neutral on questions of causation and the evolution of the mind. Furthermore, it can capture better what is distinctively “mental” about mental disorder. On the proposed view, it is the rational relations among an individual’s attitudes and actions that are “disordered” and the relevant norms in mental disorder are the norms of reasons. As further merits, the view can account for degrees of disorder, incorporate biological as well as social aspects, and elucidate the relations among disorders, symptoms, and their causes. (shrink)

The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new (...) vision of care. Molecular tumor boards are one response to these changes and are now providing better access to next-generation sequencing and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent documents at all academic medical centers and to introduce dynamic and electronic informed consent. (shrink)

This essay provides an account of how to distinguish between health and pathology of trait tokens in medical theory. It proposes to distinguish between two health/pathology concepts—health/pathology pertaining to survival and health/pathology pertaining to reproduction. It defines measures for survival-efficiency and reproduction-efficiency of performances of physiological functions. It provides an account of how, using the efficiency measures, to draw the line between health and pathology. The account draws, but seeks to improve, on Christopher Boorse’s biostatistical theory. In relation to that (...) theory, the suggested account has the advantages that it defines efficiency and that it harmonizes with judgments in medical theory in cases of common diseases and “normal aging.” Furthermore, the essay argues against a competing idea of how to improve on the biostatistical theory, advocated by Peter Schwartz and Daniel Hausman. (shrink)

There is a conceptual crisis in the biomedical sciences that is particularly salient in psychopathology research. Underlying the crisis is a controversy that pertains to the current medical model of disease that largely draws from causal-mechanistic explanations. The bedrock of this model is the analysis of biological part-dysfunctions that aims at unequivocally defining a pathological condition and demarcating it from its neighboring entities. This endeavor has led to a quest for physiological, biochemical, and genetic signatures. Yet, so far there is (...) little evidence for reliable biomarkers for any mental disorder. The contemporary biomedical paradigm largely ignores historical, dynamic, and system-level aspects—a view that has contributed much to the conceptual disjunction of the patient as a person from his/her disease. Notwithstanding the impressive progress in the biomedical sciences, increasingly more critics question whether the constituting framework is sufficient to convey a comprehensive understanding of illnesses, especially mental illnesses. Thus, the medical model urgently requires an update. But rather than revamping it by methodological advancements, it will be necessary to critically review its philosophical roots. The most problematic issues that require reworking are: the preponderance of the biostatistical theory; the undue decoupling of physiological from evolutionary explanations of function; the clinging to the Modern Synthesis ; and the neglect of dynamic and system-level properties. The proposed overhaul requires the heeding of historical explanations that draw from the Extended Evolutionary Synthesis as well as systems biology approaches for tackling multilevel and dynamic phenomena of complex systems. (shrink)

The core idea of statistical accounts of biological functions is that to function normally is to provide a statistically typical contribution to some goal state of the organism. In this way, statistical accounts purport to naturalize the teleological notion of function in terms of statistical facts. Boorse’s, 542–573, 1977) original biostatistical account was criticized for failing to distinguish functions from malfunctions. Recently, many have attempted to circumvent the criticism, 519–541, 2012, Journal of Medicine and Philosophy, 39, 634–647, 2014). Here, I (...) review such attempts and find them inadequate. The reason, ultimately, is that functional attribution depends on how traits would behave in relevant situations, a condition that resists statistical characterizations in terms of how they typically behave. This, I conclude, undermines the attempt to naturalize functions in statistical terms. (shrink)

Drawing on Christopher Boorse's Biostatistical Theory (BST), Norman Daniels contends that a genuine health need is one which is necessary to restore normal functioning – a supposedly objective notion which he believes can be read from the natural world without reference to potentially controversial normative categories. But despite his claims to the contrary, this conception of health harbors arbitrary evaluative judgments which make room for intractable disagreement as to which conditions should count as genuine health needs and therefore which needs (...) should be met. I begin by offering a brief summary of Boorse's BST, the theory to which Daniels appeals for providing the conception of health as normal functioning upon which his overall distributive scheme rests. Next, I consider what I call practical objections to Daniels's use of Boorse's theory. Finally I recount Elseljin Kingma's theoretical objection to Boorse's BST and discuss its impact on Daniels's overall theory. Though I conclude that Boorse's view, so weakened, will no longer be able to sustain the judgments which Daniels's theory uses it to reach, in the end, I offer Daniels an olive branch by briefly sketching an alternative strategy for reaching suitably objective conclusions regarding the health and/or disease status of various conditions. (shrink)

The socioeconomic and ethnic characteristics of parents are some of the most important correlates of adverse health outcomes in childhood. However, the relationships between ethnic, economic, and behavioral factors and the health outcomes responsible for this pervasive finding have not been specified in child health epidemiology. The general objective of this paper is to propose a theoretical approach to the study of maternal behaviors and child health in diverse ethnic and socioeconomic environments. The specific aims are: (a) to describe a (...) causal pathway between the utility that women obtain through work outside the home and through child care and disease hazard rates in childhood using an optimization model; (b) to specify the influence of ethnic and socioeconomic factors on model constraints; (c) to use the model as a tool to learn about how different combinations of maternal wage labor and child care time might influence child health outcomes in diverse social contexts; (d) to identify parameters that will require measurement in future research; (e) to discuss research strategies that will enable us to obtain these measurements; and (f) to discuss the implications of the model for biostatistical modeling and public health intervention. Optimization models are powerful heuristic tools for understanding how ethnic, environmental, family, and personal characteristics can place important constraints on both the quality and quantity of care that women can provide to their children. They provide a quantitative appreciation for the difficult trade-offs that most women face between working in order to purchase basic goods that children cannot do without (e.g., food, clothing, shelter, health insurance), and increasing offspring well-being through child care (e.g., training in social skills, affection, protection from environmental hazards, help with homework). (shrink)

This article presents an overview of generally available applications for creating multimedia and interactive educational materials, such as presentations, instructional videos, self-tests and interactive repetitions. With the use of the presented tools, pilot materials were developed to support the teaching of biostatistics at a medical university. The authors conducted surveys among students of faculties of medicine in order to evaluate the materials used in terms of quality and usefulness. The article presents the analysis of the results obtained.

La possibilité d’une définition naturaliste de la santé et d’une distinction entre le normal et le pathologique qui ne repose pas sur des normes culturelles, sociales ou subjectives est au cœur des débats en philosophie de la médecine. Or le concept statistique de la normalité, fondamental pour une définition objective de la santé, soulève d’importantes difficultés. Christopher Boorse défend une « théorie bio-statistique » qui, en articulant ce concept à une notion non normative de fonction biologique, résoudrait ces difficultés. L’identification (...) de la santé et de la normalité au sens statistique demeure toutefois centrale dans sa définition. Après avoir précisé le rôle que joue la normalité statistique dans la BST, nous dégageons, à partir de l’épidémiologie contemporaine, un certain nombre de problèmes et questions que cette définition naturaliste soulève.The liability for a naturalist definition of health and for a value-free distinction between the normal and the pathological is at the core of discussions on health and disease in philosophy of medicine. But the statistical concept of normality, a central one for any objective definition of health, raises numerous problems. Christopher Boorse argues for a « biostatistical theory » which aims at solving these difficulties by articulating a statistical concept of normality and a non-normative concept of biological function. However the BST is still based on identifying normality and health with the most frequent. After analyzing in details the true role of statistical normality in BST, I will show how results and data from modern epidemiology can be mobilized to reveal several limits and difficulties with respect to this naturalist definition of health and disease. (shrink)

Through hypothetical scenarios, this paper analyses whether machine learning (ML) could resolve one of the main shortcomings present in Christopher Boorse’s Biostatistical Theory of health (BST). In doing so, it foregrounds the boundaries and challenges of employing ML in formulating a naturalist (i.e., prima facie value-free) definition of health. The paper argues that a sweeping dataist approach cannot fully make the BST truly naturalistic, as prior theories and values persist. It also points out that supervised learning introduces circularity, rendering it (...) incompatible with a naturalistic perspective. Additionally, it underscores the need for pre-existing auxiliary theories to assess results from unsupervised learning. It emphasizes the importance of understanding the epistemological entanglements between data and data processing methods to manage expectations about what data patterns can predict. In conclusion, the paper argues against delegating the final authority for defining complex concepts like health to AI systems, as it necessitates ethical judgment and capacities for deliberation that AI currently lacks. It also warns against granting creators and deployers of AI systems the discretionary authority to determine these definitions outside the wider social discussion, advocating for ongoing public engagement on normative notions. Failure to do so risks limiting individuals and collectives’ ability to shape a just digital future and diminishes their fundamental epistemic agency. (shrink)

Drawing on Christopher Boorse's Biostatistical Theory (BST), Norman Daniels contends that a genuine health need is one which is necessary to restore normal functioning – a supposedly objective notion which he believes can be read from the natural world without reference to potentially controversial normative categories. But despite his claims to the contrary, this conception of health harbors arbitrary evaluative judgments which make room for intractable disagreement as to which conditions should count as genuine health needs and therefore which needs (...) should be met. I begin by offering a brief summary of Boorse's BST, the theory to which Daniels appeals for providing the conception of health as normal functioning upon which his overall distributive scheme rests. Next, I consider what I call practical objections to Daniels's use of Boorse's theory. Finally I recount Elseljin Kingma's theoretical objection to Boorse's BST and discuss its impact on Daniels's overall theory. Though I conclude that Boorse's view, so weakened, will no longer be able to sustain the judgments which Daniels's theory uses it to reach, in the end, I offer Daniels an olive branch by briefly sketching an alternative strategy for reaching suitably objective conclusions regarding the health and/or disease status of various conditions. (shrink)

If there is any value in the idea that disease is something other than the mere absence of health then that value must lie in the way that diseases are classified. This paper offers further development of a view advanced previously, the 'contrastive model' of disease: it develops the account to handle asymptomatic disease ; and in doing so it relates the model to a broadly biostatistical view of health. The developments are prompted by considering cancers featuring viruses as prominent (...) causes, since these appear to amount to cases where the prescriptions of the contrastive model could be followed, but aren't. The resulting irrelevance objection claims that the contrastive model is irrelevant to medical science and practice. The paper seeks to rebut the irrelevance objection. (shrink)