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Rationality in Context: Regulatory Science and the Best Scientific Method
Abstract
Is there such a thing as a “best scientific methodology” in regulatory (decision-oriented) science? By examining cases from varying regulatory processes, we argue that there is no best scientific method for generating decision-relevant data. In addition, in regulatory science, the most suitable methodologies often differ from what is considered best practice in knowledge-oriented (academic) science. In data generation for regulatory purposes, we are faced with a wide spectrum of preferred methodologies as well as controversy as to methodological choice. What goes by the most adequate scientific method can and will—justifiably and rationally—vary significantly according to context and use. In order to make this argument, we analyze four case studies, two from risk assessment and two from benefit assessment. Our analysis shows that it is the noncognitive objectives of a particular regulatory process that determine what counts as the most appropriate scientific method. We use the concept of bounded rationality to indicate that those methodological choices, despite being context-dependent, can be interpreted as rational.
... Proving the health benefits of consuming foods is, however, often challenging for various reasons: nutrition is known to result in multiple, but subtle, effects; the biomarkers that are used may be more appropriate for reflecting a state of disease rather than health processes; and it may require a long timeframe to establish the actual impact of nutrients (Blumberg et al., 2010;De Boer et al., 2014;Stroeve et al., 2015;Weseler and Bast, 2012;Witkamp, 2021). The low number of authorised health claims has therefore also been (partially) explained in the literature to be due to the reliance on RCTs to establish health effects of nutrition (De Boer, 2021;Lenssen et al., 2018;Todt and Luján, 2021). Trials, or human intervention studies, are considered the type of experimental study design that has the best ability to establish causal relationships between the intake of substances and biomarkers of health. ...
This chapter chronicles emerging evidence-based disciplines which can directly support research integrity—translational science, regulatory science, and meta-science. Movement toward precision of scientific standards is uneven, perhaps in part because there has been little accountability and few consequences for poor quality science. There has also been little investment in well-validated measurement instruments and methods for studying research integrity decisions themselves. Research ethics, which preceded the broader notion of research integrity, developed largely without an evidence base, in part because it was broadly assumed that scientific institutions were operating honestly, precluding the need for documenting that they were, indeed, doing so.KeywordsScientific standardsResearch synthesisScientific recordTranslational scienceRegulatory scienceMeta-scienceEvidence-based policyMeasurement relevant to research integrityIntegrity of research evidence
In this paper we argue for a naturalistic solution to some of the methodological controversies in regulatory science, on the basis of two case studies: toxicology (risk assessment) and health claim regulation (benefit assessment). We analyze the debates related to the scientific evidence that is considered necessary for regulatory decision making in each of those two fields, with a particular attention to the interactions between scientific and regulatory aspects. This analysis allows us to identify two general stances in the debate: a) one that argues for more permissive standards of evidence and for methodological pluralism, and b) an opposing one that not only defends strict evidence requirements but also stipulates the use of one particular (or at most a few) scientific methodologies for data generation. We argue that the real-world outcomes produced by alternative regulatory options are a vital piece of information that allows for the empirical assessment of these two stances. In particular, this information on outcomes makes it possible to analyze which standards of evidence and scientific methods generate the most useful knowledge as input for regulatory decision making. Our conclusion is that instead of an a priori selection of methodologies and standards, such decisions ought to be based on empirical evidence related to real-world outcomes.
http://philsci-archive.pitt.edu/18455/
Toxicology and safety assessment are changing and require new strategies for evaluating risk that are less depending on apical toxicity endpoints in animal models and relying more on knowledge of the mechanism of toxicity. This manuscript describes a number of developments that could contribute to this change and implement this in a stepwise roadmap that can be applied for the evaluation of food and food ingredients.The roadmap was evaluated in four case studies by using literature and existing data. This preliminary evaluation was shown to be useful. However, this experience should be extended by including examples where experimental work needs to be included. To further implement these new insights in toxicology and safety assessment for the area of food and food ingredients, the recommendation is that stakeholders take action in addressing gaps in our knowledge, e.g. with regard to the applicability of the roadmap for mixtures and food matrices. Further development of the threshold of toxicological concern is needed, as well as cooperation with other sectors where similar schemes are under development. Moreover, a more comprehensive evaluation of the roadmap, also including the identification of the need for in vitro experimental work is recommended.
This fully revised and updated edition begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries and explores the latest regulatory changes and their impacts. The book demonstrates the global scenario of the acceptance and demand for these products and explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as addressing the intricate aspects of manufacturing procedures. As the public gains confidence in the quality of these products based on sophisticated quality control, a broad spectrum of safety studies and GRAS, peer-reviewed publications and cutting-edge human clinical studies have emerged. An increasing number of additional populations around-the-world now recognize the efficacy and functions of nutraceuticals and functional foods as established by those scientific research studies. As a result, a number of structurally and functionally active novel nutraceuticals and several new functional beverages have been introduced into the marketplace around the world.
This paper addresses the use of systematic review and meta-analysis to evaluate the strength of evidence for health benefits of probiotic foods, especially relating to health claim substantiation in the European Union. A systematic review is a protocol-driven, transparent and replicable approach, widely accepted in a number of scientific fields, and used by many policy-setting organizations to evaluate the strength of evidence to answer a focused research question. Many systematic reviews have been published on the broad category of probiotics for many different outcomes. Some of these reviews have been criticized for including poor quality studies, pooling heterogeneous study results, and not considering publication bias. Well-designed and -conducted systematic reviews should address such issues. Systematic reviews of probiotics have an additional challenge - rarely addressed in published reviews - in that there must be a scientifically sound basis for combining evidence on different strains, species or genera. The European Food Safety Authority (EFSA) is increasingly adopting the systematic review methodology. It remains to be seen how health claims supported by systematic reviews are evaluated within the EFSA approval process. The EFSA Panel on Dietetic Products, Nutrition and Allergies deems randomized trials to be the best approach to generating evidence about the effects of foods on health outcomes. They also acknowledge that systematic reviews (with or without meta-analyses) are the best approach to assess the totality of the evidence. It is reasonable to use these well-established methods to assess objectively the strength of evidence for a probiotic health claim. Use of the methods to combine results on more than a single strain or defined blend of strains will require a rationale that the different probiotics are substantively similar, either in identity or in their mode of action.
Europe's push towards a single harmonised market that offers information on the benefits of foods is encapsulated in Regulation (EC) No 1924/2006, the Nutrition and Health Claims Regulation (NHCR). The NHCR will be the main focus of our contribution. Our contention is that this regulation not only stifles scientific research, limiting it to the relationship between nutrition and health, but also hinders Europe's public health, especially with respect to the intake of micronutrients. We will analyse this with the aid of some aspects of the current state-of-the-art in the nutritional sciences.
The present regulation of carcinogens is quite slow; hundreds of substances that have tested positive for carcinogenicity in animal bioassays have not been addressed by the U.S. regulatory system. This carries with it unappreciated social, economic, and public health costs. However, there are readily available expedited approximation procedures for assessing the potency of carcinogens whose use has substantial benefits that outweigh any costs from less science-intensive and less extensively documented assessments. These benefits can be seen by using a model to suggest the magnitude of social costs in regulating carcinogens by current conventional methods compared with expedited procedures for assessing the potency of known carcinogens. Two scenarios, one in accordance with current agency presumptions and one which assumes extreme unreliability in animal data and in the accuracy of potency assessments, compare conventional science-intensive and expedited procedures. On both, the total social costs of expedited procedures are lower than conventional procedures across a wide range of values assigned for individual mistakes of under regulation and over regulation. It appears better to evaluate a larger universe of known carcinogens somewhat less intensively for each substance than to evaluate a small proportion of that same universe very carefully and delay considering the rest.
The evolution of chemical risk assessment has been marked by a steadily increasing expectation for the use of chemical-specific dosimetric and mechanistic information to tailor the risk assessment approach. The information to be used can range from the broad physical properties of the chemical to detailed information on the mechanism by which it causes a particular toxic outcome, and the risk assessment decisions effected can in turn range from how to define equivalent exposures across species to whether a particular animal outcome is relevant to a human health assessment. A concept that has proven useful in support of these considerations is the "mode of action," a term coined by the USEPA in their new guidelines for carcinogen risk assessment. This paper describes the increasing use of mode-of-action considerations in risk assessment, beginning with early examples involving quantitative dosimetry on the one hand, and qualitative relevance on the other, which foreshadowed the current interest in mode of action. It then describes more recent developments regarding the use of the mode-of-action concept for the selection of a low-dose extrapolation approach, for harmonization of cancer and noncancer risk assessment approaches, and for cross-chemical evaluations. Finally, examples of recent controversies associated with the use of mode-of-action information in risk assessment are provided to demonstrate the challenges that must be overcome to assure the continued viability of the mode-of-action approach.
This talk's title comes from a tobacco executive's memo: "Doubt is our product since it is the best means of competing with the 'body of fact' that exists in the minds of the general public. It is also the means of establishing a controversy. Although Big Tobacco manufactured more uncertainty over a longer period and more effectively than any other industry, the strategy of manufacturing uncertainty has been used with great success by numerous polluters and manufacturers of dangerous products to oppose public health and environmental regulation. It is central to the debate on global warming, and arises often in considering the safety of drugs and medical devices, and of consumer products. The approach is now so common that it is unusual for an industry not to challenge the science behind any regulation it faces.
Manufacturing uncertainty has become a business in itself; numerous technical consulting firms advertise product defense or litigation support. The firms, and the scientists who own and operate them, sell not just their scientific expertise, but their knowledge of and access to regulatory agencies. The financial success of these firms depends on their ability to help their clients avoid increased regulation. Not surprisingly, it is rare for these firms to produce a study whose results conflict with the needs of the study sponsor. It follows that these scientists' financial conflicts of interest are so severe that they should be barred from serving on federal science advisory panels that inform public health policy.
Opponents of public health and environmental regulations often try to “manufacture uncertainty” by questioning the validity of scientific evidence on which the regulations are based. Though most identified with the tobacco industry, this strategy has also been used by producers of other hazardous products. Its proponents use the label “junk science” to ridicule research that threatens powerful interests.
This strategy of manufacturing uncertainty is antithetical to the public health principle that decisions be made using the best evidence available. The public health system must ensure that scientific evidence is evaluated in a manner that assures the public’s health and environment will be adequately protected.
European food laws increasingly use scientific evidence to protect consumers from hazards and to prevent the use of misleading information. In this article, the use of risk assessment in European food law is analysed and the implications of the recently adopted adjustments to the EU's General Food Law are reviewed. The risk analysis cycle that has been implemented in many authorisation decisions of the European Commission has resulted in the increased level of public health protection since 2002. The food law evaluation under REFIT however identified various shortcomings, including the civil societies' perception that various elements of EFSA's work lacked transparency and independence. To deal with these identified issues, the newly adopted regulation will bring about specific adjustments to the General Food Law and sectorial legislation. Although these adjustments are expected to improve European food policies, today's EU food laws should be further enhanced by improving the use of nutritional sciences in food law. Such joint efforts can result in a higher level of consumer protection and further advance the internal European market. Only through improving the systematic way to conduct scientific analyses into and by enhancing their use in risk management, European food law will become more future-proof.
Background
The Health Claims Regulation entered into force in January 2007. The European Food Safety Authority (EFSA) has evaluated more than 3000 health claims since then, but EFSA's responsibilities in this area and the extent to which its scientific assessments are in accordance with the current legal framework are still not fully understood.
Scope and approach
The scope of this paper is to provide insight on the use of scientific knowledge in the area of nutrition for the substantiation of health claims made on food. The reasons why a positive evaluation by EFSA may not be sufficient for the authorisation of a health claim are also discussed. Concrete examples are used to illustrate these aspects.
Key findings and conclusions
How health claims are scientifically assessed by EFSA has not been fully understood by stakeholders yet. Thorough knowledge on how EU legislation translates into scientific requirements for substantiation is essential to building successful applications. Other factors which may play a role in the authorisation of a claim and which are not evaluated by EFSA, such as the legal status of the food/constituent, its safety, or the compatibility of the claim with national and international dietary recommendations, should also be considered early in the process. EFSA is committed to providing further guidance to stakeholders on how to prepare applications for authorisation by making use of its 10 years of experience on the scientific evaluation of health claims made on food.
This article analyzes the debate about data acquisition and assessment in health claims regulation by identifying the underlying controversies on methodological choice. Regulation in the European Union imposes the need for a scientific substantiation of all health claims (claims about a relationship between consumption of certain food ingredients and positive health effects). Randomized controlled trials (RCTs) are the method that generally is considered to provide the highest quality data for decision making in claims regulation because they allow for establishing cause-effect relationships. The latter are demanded in European regulatory practice for authorization of a claim. This requirement has contributed to a debate about the advantages and limitations of the RCT methodology in nutrition research and regulation. Our analysis identifies five types of tensions that underlie the controversy, with respect to evidence, cognitive values, standards of proof, future lines of research, as well as expert judgment. We conclude that there is a direct and mutual interaction between methodological decisions in nutrition science, and different strategies in health claims regulation. The latter have social and public health consequences because not only may they affect the European market for functional foods, as well as concomitant consumption patterns, but also the generation of future regulation-relevant evidence in nutrition.
Background Functional foods are closely associated with claims on foods. There are two categories of claims on foods: nutrition claims and health claims. Nutrition claims refer to what a food contains and comprise content claims and comparative claims. Health claims refer to what a food does and refer to general function claims, claims related to a reduction of risk of disease and claims related to the growth and development of children. Scope and approach Health claims on (functional) foods must be scientifically substantiated. In December 2006, the European Union published Regulation 1924/2006 on nutrition and health claims made on foods. The European Food Safety Authority (EFSA) provides the scientific advice to the European Commission for health claims submitted under Regulation 1924/2006. By 2015, EFSA has evaluated around 3000 health claims. Key findings and conclusions The outcome of the scientific evaluation process was that ca 250 health claims have been evaluated with a positive outcome, a few with insufficient evidence, whereas the large majority of health claims proposals were evaluated with the conclusion that the claim was not supported by scientific evidence. In addition to hundreds of opinions on health claims, EFSA has published various guidelines related to the scientific substantiation of health claims on foods and guidance documents for health claims related to diverse health endpoints. Upon scientific evaluation by EFSA, it is up to the European Commission and the member States to decide on authorisation. EU Regulation 432/2012 has established a list of general function claims under article 13 of Regulation 1924/2006. Most health claims that have been approved and authorised are in the area of general functions claims for vitamins, minerals and other nutrients. EFSA hitherto has not found sufficient scientific support for health claims on microorganisms except for lactose digestion by yoghurt bacteria, and only a few on “antioxidants”. There are several substantiated health claims in the area of fibres and oligosaccharides. As from 14 December 2012, all claims that are not authorised or on hold/under consideration are prohibited.
There is a need for integrated thinking about causality, probability, and mechanism in scientific methodology. A panoply of disciplines, ranging from epidemiology and biology through to econometrics and physics, routinely make use of these concepts to infer causal relationships. But each of these disciplines has developed its own methods, where causality and probability often seem to have different understandings, and where the mechanisms involved often look very different. This variegated situation raises the question of whether progress in understanding the tools of causal inference in some sciences can lead to progress in other sciences, or whether the sciences are really using different concepts. Causality and probability are long-established central concepts in the sciences, with a corresponding philosophical literature examining their problems. The philosophical literature examining the concept of mechanism, on the other hand, is more recent and there has been no clear account of how mechanisms relate to causality and probability. If we are to understand causal inference in the sciences, we need to develop some account of the relationship between causality, probability, and mechanism. This book represents a joint project by philosophers and scientists to tackle this question, and related issues, as they arise in a wide variety of disciplines across the sciences.
Samuels and Stich explore the debate over the extent to which ordinary human reasoning and decision making is rational. One prominent cluster of views, often associated with the heuristics and biases tradition in psychology, maintains that human reasoning is, in important respects, normatively problematic or irrational. Samuels and Stich start by sketching some key experimental findings from this tradition and describe a range of pessimistic claims about the rationality of ordinary people that these and related findings are sometimes taken to support. Such pessimistic interpretations of the experimental findings have not gone unchallenged however: Samuels and Stich outline some of the research on reasoning that has been done by evolutionary psychologists and sketch a cluster of more optimistic theses about ordinary reasoning that such psychologists defend. Although Samuels and Stich think that the most dire pronouncements made by writers in the heuristics and biases tradition are unwarranted, they also maintain that the situation is rather more pessimistic than sometimes suggested by evolutionary psychologists. They conclude by defending this "middle way" and sketch a family of "dual processing" theories of reasoning which, they argue, offer some support for the moderate interpretation they advocate.
This book in the philosophy of law and risk assessment is concerned with the topic of the standards of evidence in legal proceedings and regulatory decisions regarding the toxicity of chemicals. The book argues that the scientific and statistical criteria usually used to determine whether substances are toxic are too rigorous and time-consuming for evidentiary purposes in tort cases and for regulation. The result is the under-regulation of toxic substances and the under-compensation of plaintiffs in tort cases. The book proposes the evidential standards now used should be evaluated with the purposes of the law in mind.
Where do new ideas come from? What is social intelligence? Why do social scientists perform mindless statistical rituals? This vital book is about rethinking rationality as adaptive thinking: to understand how minds cope with their environments, both ecological and social. The author proposes and illustrates a bold new research program that investigates the psychology of rationality, introducing the concepts of ecological, bounded, and social rationality. His path-breaking collection takes research on thinking, social intelligence, creativity, and decision-making out of an ethereal world where the laws of logic and probability reign, and places it into our real world of human behavior and interaction. This book is accessibly written for general readers with an interest in psychology, cognitive science, economics, sociology, philosophy, artificial intelligence, and animal behavior. It also teaches a practical audience, such as physicians, AIDS counselors, and experts in criminal law, how to understand and communicate uncertainties and risks.
This book examines a variety of ways in which societal values can be more effectively integrated into the numerous judgments associated with policy-relevant environmental research. It provides a detailed analysis of contemporary research on the hypothesis of hormesis (i.e., beneficial biological effects caused by low-dose exposure to pollutants that are ordinarily toxic). On the basis of this analysis, as well as shorter case studies of endocrine disruption and multiple chemical sensitivity, the book proposes three lessons. First, university conflict-of-interest policies are significantly limited in their ability to prevent interest groups from "hijacking" academic research on sensitive policy-relevant topics. Therefore, alternative strategies are needed to preserve science that serves the public interest. Second, concerned citizens and policy makers need to more carefully determine the most appropriate forms of broadly based deliberation to be employed in response to specific areas of sensitive, policy-relevant research. Third, the principle of informed consent, which currently provides guidance in the medical field, suggests a promising ethical framework that can help environmental scientists who disseminate debated findings to the public. Throughout, the book highlights many of the crucial ethical and societal questions surrounding research on the hormesis hypothesis. It thereby constitutes the first book-length manuscript to provide guidance to the concerned citizens, industry groups, scientists, and policy makers who are exploring ways to respond to this phenomenon.
Over the last twenty or so years, it has become standard to require policy makers to base their recommendations on evidence. That is now uncontroversial to the point of triviality—of course, policy should be based on the facts. But are the methods that policy makers rely on to gather and analyze evidence the right ones? In Evidence-Based Policy, Nancy Cartwright, an eminent scholar, and Jeremy Hardie, who has had a long and successful career in both business and the economy, explain that the dominant methods which are in use now—broadly speaking, methods that imitate standard practices in medicine like randomized control trials—do not work. They fail, Cartwright and Hardie contend, because they do not enhance our ability to predict if policies will be effective.
The prevailing methods fall short not just because social science, which operates within the domain of real-world politics and deals with people, differs so much from the natural science milieu of the lab. Rather, there are principled reasons why the advice for crafting and implementing policy now on offer will lead to bad results. Current guides in use tend to rank scientific methods according to the degree of trustworthiness of the evidence they produce. That is valuable in certain respects, but such approaches offer little advice about how to think about putting such evidence to use. Evidence-Based Policy focuses on showing policymakers how to effectively use evidence. It also explains what types of information are most necessary for making reliable policy, and offers lessons on how to organize that information.
The growing worldwide interest on functional food research has been accompanied by increasing regulatory guidelines in this area, with the aim of ensuring that any claimed effect in foods, beyond their nutritional role, is based on scientific unequivocal evidence. In order to assess the cause-effect relationship between the regular consumption of a food or a food component and the beneficial outcome for the consumer, an appropriate study design is required. Previous knowledge and research on the specific claimed food or product may be an adequate basis for defining a hypothesis and accurate objectives. Other key factors to take into account are based on the outcomes studied, the length of the trial, sample size and type, as well as the transparency on reporting the results obtained. Based on the Consolidated Standards on Reporting Trials statement (CONSORT), together with the specific guidelines published by the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies, the present article aims at summarizing key questions conducting to the most appropriate study design for solid health claim substantiation.
The increasing public interest in dietary health benefits led to the development of different legislative texts on nutrition and health claims worldwide. Following a review of legislation of 28 jurisdictions, three prominent differences were discerned, concerning (i) the labelling of different types of nutrition and health claims and their permission; (ii) variations arising in the (pre-marketing) authorisation procedures; and (iii) the use of the scientific minority opinion in substantiating claims. By discussing these legal differences with findings from literature concerning consumer and industry effects, this review puts these pieces of legislation into a broader perspective. The studied pieces of legislation show critical differences and although various approaches have positive points, no optimal approach to regulate nutrition and health claims has been implemented yet. It would be preferable to permit similar types of claims throughout jurisdictions, permit claims that have a lower probability of misleading consumers e.g. nutrition claims to use emerging evidence and to require pre-marketing approval of claims with higher impact. International harmonisation in these aspects should globally lead to improved pieces of legislation, stimulate industrial efforts in functional foods and enhance consumers’ opportunity to use health-enhancing products.
The high prevalence of obesity and its associated illnesses, such as cancer, heart disease and diabetes, has sparked interest in finding ways to encourage consumers to make healthier food choices. At the public level, providing information about why and how to choose a healthy diet has been the typical approach to encouraging behavioral change. Information can also influence food producers and marketers to develop and promote more healthful products, creating an environment in which it is easier for consumers to make healthier dietary choices. Nevertheless, information may not always be effective in improving food choices. One explanation is that nutrition information is complex and difficult to convey in a clear, actionable manner. Also, knowledge, while necessary, may not be sufficient to motivate behavior change. Even when consumers understand nutrition information, competing preferences for tastier, less expensive, or more convenient foods may lead them to make other choices. Findings from psychology, marketing, and behavioral economics research suggest approaches that may enhance the effectiveness of informational approaches and complement informational efforts. More research is needed to further develop these strategies and evaluate their effectiveness.
On classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
This article analyses the consequences of the implementation of the nutrition and health claim regulation in the field of food products containing antioxidants or food products claiming antioxidant activity. To this end, it first examines the origin and creation of the regulation and the involvement of EFSA in assessing scientific substantiation of health claims. Three criteria are regarded as critical in EFSA’s opinions on the scientific substantiation of a health claim: the claimed effect i) is well defined; ii) is a clear beneficial physiological effect; and iii) shows a cause effect relationship with the consumption of the food or functional ingredient. These criteria have implications for the research requested to substantiate health claims, although these implications do not all seem to fit nutrition research as it is currently executed. Looking at antioxidants, the complexity of the mechanisms and actions of antioxidants is not recognised by the criteria used to evaluate proposed health claims, nor by the methodologies used to assess the effects of antioxidants. These criteria should be adjusted with novel scientific insights after consulting stakeholders.
Critics of the ideal of value-free science often assume that they must reject the distinction between epistemic and nonepistemic values. I argue that this assumption is mistaken and that the distinction can be used to clarify and defend the argument from inductive risk, which challenges the value-free ideal. I develop the idea that the characteristic feature of epistemic values is that they promote, either intrinsically or extrinsically, the attainment of truths. This proposal is shown to answer common objections to the distinction and provide a principled basis for separating legitimate from illegitimate influences of nonepistemic values in scientific inference. Copyright 2010 by the Philosophy of Science Association. All rights reserved.
US testing of nuclear weapons has resulted in about 800,000 premature fatal cancers throughout the globe, and the nuclear tests of China, France, India, Russia, and the UK have added to this total. Surprisingly, however, these avoidable deaths have not received much attention, as compared, for example, to the smaller number of US fatalities on 9-11-01. This essay (1) surveys the methods and models used to assess effects of low-dose ionizing radiation from above-ground nuclear weapons tests and (2) explains some of the epistemological and logical problems (with these methods and models) that have caused scientists to decide against health screening of the most likely test victims. It also (3) argues that, once the faulty presuppositions and question-begging frames about testing and screening are recognized, there are compelling arguments in favor of nuclear-test nations'' screening fallout victims, at least among their citizens. Finally, it (4) suggests that logically and epistemically flawed fallout studies/recommendations against screening are more like to occur when scientists adopt a Laudan-style comparativist rationality, rather than when they adopt a metascience more like that of Kuhn and others.
Randomized clinical trials are the gold standard of pharmacology and are the only way to provide solid and evidence-based data. However, they are difficult to apply to nutrition-based settings. This article outlines the major differences between pharmacology and nutrition research and indicates some potential pathways to follow during claim building.
In Europe, for authorisation of a health claim, applicants must follow the procedures in the legislation and in the guidelines for submission of a dossier set out by the European Food Safety Authority. The Functional Foods in Europe (FUFOSE) and Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) projects underpinned the laws and provided criteria against which the quality of the totality of the available data could be judged. Whereas the regulations and PASSCLAIM require an assessment of the extent to which cause and effect can be demonstrated between a food category, a food or constituent and a health benefit, the European Food Safety Authority requires conclusive evidence of cause and effect. This latter standard of proof and a focus on randomised controlled trials done on isolated components and using validated physiological biomarkers may not always be appropriate to assess nutrition science. The aims of this paper are to address the strengths and weaknesses of different sources of evidence that contribute to the totality of the available data, to undertake a critical examination of the application of a drug-like assessment model in evidence-based nutrition and to encourage research on new biomarkers of health and homeostatic adaptability. There is a need for (a) a robust and pragmatic scientific framework for assessing the strength, consistency and biological plausibility of the evidence, and (b) consumer understanding research on claims that use qualifying language and/or graphics to reflect the weight of evidence. Such scientific, policy and communication approaches are proportionate and could help stimulate academic research, promote fair trade and product innovation and contribute to consumer education about food and health.
1st Issued as Paperback Bibliogr. na konci kapitol
During the last decade, approaches to evidence-based medicine, with its heavy reliance on the randomized clinical trial (RCT), have been adapted to nutrition science and policy. However, there are distinct differences between the evidence that can be obtained for the testing of drugs using RCTs and those needed for the development of nutrient requirements or dietary guidelines. Although RCTs present one approach toward understanding the efficacy of nutrient interventions, the innate complexities of nutrient actions and interactions cannot always be adequately addressed through any single research design. Because of the limitations inherent in RCTs, particularly of nutrients, it is suggested that nutrient policy decisions will have to be made using the totality of the available evidence. This may mean action at a level of certainty that is different from what would be needed in the evaluation of drug efficacy. Similarly, it is judged that the level of confidence needed in defining nutrient requirements or dietary recommendations to prevent disease can be different from that needed to make recommendations to treat disease. In brief, advancing evidence-based nutrition will depend upon research approaches that include RCTs but go beyond them. Also necessary to this advance is the assessing, in future human studies, of covariates such as biomarkers of exposure and response, and the archiving of samples for future evaluation by emerging technologies.
Functional foods are closely associated with claims on foods. There are two categories of claims on foods: nutrition claims and health claims. Health claims on (functional) foods must be scientifically substantiated. In December 2006, the European Union published its Regulation 1924/2006 on nutrition and health claims made on foods. As concerns scientific evaluation, the EU-project PASSCLAIM resulted in a set of criteria for the scientific substantiation of health claims on foods. The European Food Safety Authority provides the scientific advise to the European Commission for health claims submitted under Regulation 1924/2006 and has hitherto published several hundreds of opinions on health claims, part of which are positive, part which are negative and a few with insufficient evidence. Antioxidant claims have been approved for the general function of vitamins but not for direct health effects in humans. Another issue with claims is consumer understanding. Consumers can hardly distinguish between graded levels of evidence, and they do make only little or no distinction between nutrition and health claims. Consumers understand nutrition and health claims different from scientists and regulators. Therefore, innovation in industry can readily proceed via approved nutrition claims and approved health claims. The market and the shelves in the stores will not be empty; rather they will look different in the years to come.
The role of science in policymaking has gained unprecedented stature in the United States, raising questions about the place of science and scientific expertise in the democratic process. Some scientists have been given considerable epistemic authority in shaping policy on issues of great moral and cultural significance, and the politicizing of these issues has become highly contentious. Since World War II, most philosophers of science have purported the concept that science should be âvalue-free.â In Science, Policy and the Value-Free Ideal, Heather E. Douglas argues that such an ideal is neither adequate nor desirable for science. She contends that the moral responsibilities of scientists require the consideration of values even at the heart of science. She lobbies for a new ideal in which values serve an essential function throughout scientific inquiry, but where the role values play is constrained at key points, thus protecting the integrity and objectivity of science. In this vein, Douglas outlines a system for the application of values to guide scientists through points of uncertainty fraught with moral valence. Following a philosophical analysis of the historical background of science advising and the value-free ideal, Douglas defines how values should-and should not-function in science. She discusses the distinctive direct and indirect roles for values in reasoning, and outlines seven senses of objectivity, showing how each can be employed to determine the reliability of scientific claims. Douglas then uses these philosophical insights to clarify the distinction between junk science and sound science to be used in policymaking. In conclusion, she calls for greater openness on the values utilized in policymaking, and more public participation in the policymaking process, by suggesting various models for effective use of both the public and experts in key risk assessments.
When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. This idea, known as the "Precautionary Principle," is seen by environmentalists and public health experts as the key to protecting ecological and human health.In January 1998, the Science and Environmmental Health Network convened an international group of scientists, researchers, environmentalists, academics, and labor representatives to discuss ways of incorporating the precautionary approach into environmental and public health decision-making. Known as the Wingspread Conference on Implementing the Precautionary Principle, the workshop focused on understanding the contexts under which the principle developed, its basis, and how it could be implemented. Protecting Public Health and the Environment is an outgrowth of that conference. The book: describes the history, specific content, and scientific and philosophical foundations of the principle of precautionary action explains the functions of the principle in activities as diverse as agriculture and manufacturing explains how to know when precautionary action is needed and who decides what action will (or will not) be taken attempts to show how the burden of proof of environmental harm can be shifted to proponents of a potentially hazardous activity provides specific structures and mechanisms for implementing the precautionary principl. Throughout, contributors focus on the difficult questions of implementation and fundamental change required to support a more precautionary approach to environmental and public health hazards. Among the contributors are David Ozonoff, Nicholas Ashford, Ted Schettler, Robert Costanza, Ken Geiser, and Anderw Jordan.Public health professionals and academics, policymakers, environmental lawyers, sustainable agriculture proponents, economists, and environmental activists will find the book an enlightening and thought-provoking guide to a new way of thinking about ecosystem and public health protection.
"This volume presents an attempt to construct a unified cognitive theory of science in relatively short compass. It confronts the strong program in sociology of science and the positions of various postpositivist philosophers of science, developing significant alternatives to each in a reeadily comprehensible sytle. It draws loosely on recent developments in cognitive science, without burdening the argument with detailed results from that source. . . . The book is thus a provocative one. Perhaps that is a measure of its value: it will lead scholars and serious student from a number of science studies disciplines into continued and sharpened debate over fundamental questions."âRichard Burian, Isis "The writing is delightfully clear and accessible. On balance, few books advance our subject as well."âPaul Teller, Philosophy of Science
In this paper I have attempted to identify some of the structural characteristics that are typical of the "psychological' environments of organisms. We have seen that an organism in an environment with these characteristics requires only very simple perceptual and choice mechanisms to satisfy its several needs and to assure a high probability of its survival over extended periods of time. In particular, no "utility function' needs to be postulated for the organism, nor does it require any elaborate procedure for calculating marginal rates of substitution among different wants.
Two epistemological claims underwrite the randomized clinical trial (RCT). 1 The first, associated with Austin Bradford Hill, asserts that randomization prevents biased estimates of the value of new therapies. The second, associated with RA Fisher, maintains that randomization is necessary for the valid interpretation of statistical significance. This paper places Fisher’s views on randomization in the larger context of his views on statistical inference and the nature of science. Fisher’s life-long interest in the problem of induction, how to draw valid empirical conclusions about the world, led him to emphasize the provisional character of knowledge. The statistical methods he developed—randomization, likelihood—were aimed at producing what Fisher termed ‘rigorously specified uncertainty’. Fisher’s highly technical arguments about the nature of probability and likelihood are rooted in his more general concerns about the evolutionary and political importance of intellectual autonomy—concerns rooted in his early eugenical views but strongly reinforced by his ideological critique of Soviet science during the Cold War. Notwithstanding the esoteric origins of some of his arguments, Fisher’s ideas have great relevance for contemporary debates within evidence-based medicine. How we best distinguish what is known from what is not known, how we can emphasize the uncertainty of existing knowledge, and how we can best capture that uncertainty—all these Fisherian concerns are crucial in a time when the passage from the journal article to the press conference is increasingly swift.
"Weight of evidence" (WOE) is a common term in the published scientific and policy-making literature, most often seen in the context of risk assessment (RA). Its definition, however, is unclear. A systematic review of the scientific literature was undertaken to characterize the concept. For the years 1994 through 2004, PubMed was searched for publications in which "weight of evidence" appeared in the abstract and/or title. Of the 276 papers that met these criteria, 92 were selected for review: 71 papers published in 2003 and 2004 (WOE appeared in abstract/title) and 21 from 1994 through 2002 (WOE appeared in title). WOE has three characteristic uses in this literature: (1) metaphorical, where WOE refers to a collection of studies or to an unspecified methodological approach; (2) methodological, where WOE points to established interpretative methodologies (e.g., systematic narrative review, meta-analysis, causal criteria, and/or quality criteria for toxicological studies) or where WOE means that "all" rather than some subset of the evidence is examined, or rarely, where WOE points to methods using quantitative weights for evidence; and (3) theoretical, where WOE serves as a label for a conceptual framework. Several problems are identified: the frequent lack of definition of the term "weight of evidence," multiple uses of the term and a lack of consensus about its meaning, and the many different kinds of weights, both qualitative and quantitative, which can be used in RA. A practical recommendation emerges: the WOE concept and its associated methods should be fully described when used. A research agenda should examine the advantages of quantitative versus qualitative weighting schemes, how best to improve existing methods, and how best to combine those methods (e.g., epidemiology's causal criteria with toxicology's quality criteria).
Regulating Toxic Substances
- C Cranor
Cranor, C. 1993. Regulating Toxic Substances. New York: Oxford University Press.
General Guidance for Stakeholders on Health Claim Applications
EFSA (European Food Safety Authority). 2016. "General Guidance for Stakeholders on Health Claim Applications." EFSA Journal 14 (4367): 1-38.
Scientific and Technical Guidance for the Preparation and Presentation of a Health Claim Application
EFSA (European Food Safety Authority). 2017. "Scientific and Technical Guidance
for the Preparation and Presentation of a Health Claim Application." EFSA
Journal 15 (4680): 1-31.
Establishing Implementation Rules for Applications for Authorisation of Health Claims as Provided for in Article 15 of Regulation (EC) No 1924/ 2006 of the European Parliament and of the Council
European Commission. 2008. "Commission Regulation (EC) No 353/2008 of 18
April 2008 Establishing Implementation Rules for Applications for Authorisation of Health Claims as Provided for in Article 15 of Regulation (EC) No 1924/
2006 of the European Parliament and of the Council." Official Journal of the
European Union 51 (L.109):11-16.