Evidence‐based policies: Lessons from regulatory science

In this article, various examples of controversies in regulatory science are analyzed concerning chemical and pharmaceutical products functional foods. these controversies, it is possible to show the relationship between epistemic policies objectives (decision-making objectives). From an analysis relationship, four points must be noted that can extrapolated current evidence-based policy proposals: (1) The determine evidence hierarchies. (2) Evidence hierarchies appropriate scientific methodology and, by extension, knowledge will generated. (3) use formulation public example extrapolation, such cases should viewed as hypotheses whose testing requires from different lines research. (4) suitability a particular evidentiary hierarchy depends on what at stake; is, assessment gains losses which or regulation based requirement may lead. 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En este artículo se analizan varios ejemplos de controversias en la ciencia reguladora torno productos químicos, farmacéuticos y alimentos funcionales. estas es posible mostrar relación entre las políticas epistémicas los objetivos reguladores (los que pretenden alcanzar mediante toma decisiones). Del análisis esta pueden extraerse cuatro puntos extrapolables actuales propuestas basadas evidencias: Los determinan jerarquías evidenciales. Las evidenciales metodología científica adecuada y, por extensión, el conocimiento científico generará. El uso del formulación públicas un ejemplo extrapolación, tales casos han ser contemplados como hipótesis cuya contrastación requiere evidencias procedentes diferentes líneas investigación. La idoneidad una determinada jerarquía evidencial depende lo esté juego; decir, evaluación ganancias pérdidas puede conducir política o regulación basada tal requisito evidencial. 本文分析了监管科学中关于化学产品、医药产品和功能性食品的不同争议实例。从这些争议中可能得出认知政策与监管目标(决策目标)之间的关系。通过分析这种关系，能推断出四点，以用于当前基于证据的政策建议:(1)监管目标决定证据等级。(2)证据等级决定了适当的科学方法，进而决定了将产生的科学知识。(3)在制定公共政策时使用科学知识是推断的一个实例，并且此类实例应被视为假设，检验这些假设需要不同研究领域的证据。(4)特定证据等级的适用性取决于利害关系；也就是说，取决于对得失的评估，这一得失归因于基于此类证据要求的政策或法规。 some time now, calls have been made among groups for knowledge, both their application evaluation. This movement favor (EBP; French, 2019; Wesselink et al., 2014). These related areas (education, health care, poverty development, crime violence, labor market, etc.), they considered precedents early 20th century technocratic initiatives, proposals Vienna Circle, North American pragmatism with regard social function science, Karl Popper's piecemeal engineering. Today's version, nonetheless, directly influenced medicine (EBM) movement. It influence EBM makes EBP unique approach using management problems. aim identify therapies, treatments, procedures grounded sufficient evidence, distinguishing them others only medical practice, without having subjected systematic research (Sackett Rosenberg, 1995). objective world center treatments effectiveness has proven through obtainment empirical strictest methodologies. why establishes used way not all same worth. More specifically, randomized controlled trials (RCTs) crucial recommendation certain procedure, drug, therapy, diet, etc. observational epidemiological studies would thus ranked second, followed physiological studies, bioassays, (mechanistic evidence). Although prioritizes RCTs, identification intervention's consequences causal factors prerequisite establishment links. regard, tied recent field epidemiology (Hernan, 2005; Vandenbroucke 2016). cases, two assumptions made: establish relations limited probabilistic possibility success. To more precise, does allow quantitative effects intervention play complementary heuristic role. serves relationships. Prioritizing general belief best type principles inherited EBM. One 2019 Nobel Prize Economics. award went Abhijit Banerjee, Esther Duflo, Kremer experimental alleviate global poverty. economists promoted experiments evaluation developing countries. Randomized context consist assigning (e.g., access microcredit) group termed “treatment group” continue analogy care set villages neighborhoods), then comparing results “control applied. serve design corresponding policies. shaping, application, generated controversy, sparking off following responses: rejection very idea decisions moral ideological preferences prevail, also ideologically charged; calling into question primacy addition disagreeing marginalization other types (Haack, 2014; Caze Colyvan, 2017); analyses limitations methodologies prioritized (Cartwright Hardie, 2012; Cartwright Stegenga, 2011; 2014); proposal alternative forms interaction those implicit (Saltelli Funtowicz, 2015; Saltelli Giampietro, 2017; Sarewitz, 2000). article explores second criticism proposals, analyzing happened regulations technological products. Using shaping processes seems logical hard call question. Nonetheless, given rise numerous academic circles. Advantage taken acquired experience drafting regulation, learning lessons extended decision making EBP. Since late 1960s, applications subject governments parliaments.1 Examples include risks chemicals, environment, working conditions, safety benefits drugs. might said there no technologically area people's lives strongly regulated authorities. Regulation generally resorted protection promotion environment—the primary legislation—although (Luján Todt, 2018). subsequent require knowledge. known come fore. activity aimed providing guidance development applications. drafting, technology-related led nature. controversy prior while process itself sparks controversy. over guaranteed process; objectives. There where but, instead, differing An link us relevant characteristics (Todt Luján, 2022). Let look examples. toxic products, debate degree severity parallel, requirements needed product regarded posing risk human environment. sectors opinion, prioritizing strict due flexibility requirements. contrast, believe increases costs companies, resulting availability fewer resources guide regulations. 1970s, U.S. agencies regulate changes guidelines published Environmental Protection Agency (EPA) 1976, humans (epidemiological studies) was fundamental carcinogenic substances establishing dose–response 1983 report National Research Council (NRC, 1983) insisted importance humans, but difficulty involved obtaining interpreting it, recognizing that, many necessary data bioassays. 1985, Office Science Technology problems encounter 1986 EPA recommended assessments short-term tests, together structures biological activity, although, guidelines, still fundamental. 1996, weighing up available evidence: animals, supplementary 2009). 21st toxicity (Krewski 2009; NRC, 2007) highlights mechanistic overall assessments. proposed model begins determination properties (chemical characterizations). stage, researched, mainly vitro cell cultures. Mechanistic even choice model. reasons. Some clearly epistemic: living organisms, difficulties interactions, Others pragmatic: investigations environment protective 2009).2 pragmatic observed extrapolation models. always entails extrapolation. case assessments, most common animal models high doses low doses. When comes model, consideration. example, linear threshold, health. If one another, reasonable make considerations. Dose–response considerations interact. Taking account considerations, several authors tests (STT; Cranor, STTs are, systems (except animals) carried out few hours days. particularly important genotoxicity mutagenesis. Analyses now jurisdictions. structure–activity (SAR) (QSAR). Both lead classification structure associated metabolic effects. any substance similar molecular weight another already automatically classified potentially (in categories). Based classification, tested least provisionally, until exhaustive, slower investigation conducted could reliably its (or absence effects). words, SAR understood represent acceptance information basis making, cost less accuracy than change note reversal burden proof established European products: registration, evaluation, authorization, restriction chemicals (REACH). follows maxim “no data, market.” Industries provide substances, new market (Eriksson 2010; Silbergeld 2015). justified because deemed better achieving protecting (the Toxic Substances Control Act, TSCA) REACH giving power request companies. before approved limit regarding environmental pharmaceuticals, little debate, COVID-19 vaccine, except anti-vaccine critics business. However, questioned aspects clinical trials. A classic work Worrall, who maintains randomization necessary. According Worrall (2002, 2007), controlling unknown variables. Worrall's basically epistemic. Other arguments symmetry cases; benefit analysis. posed whether applicable both. stake other, therapeutic benefit), sense propose Osimani (2014) advocates assess pharmaceuticals. relation benefits, Hill's (1965) criteria, Landes (2018) advocate amalgamating That pluralistic evidence. Hansson (2020) believes valid tighten relax standards depending each case—for instance, pharmaceuticals versus substitution drug. proposals—those Osimani, Poellinger—are regulation. authorities adaptations requirements, contextual factors. Medicines (EMA) issue conditional authorizations, cost/benefit assessment. Fewer met authorizations standard (nonconditional) ones. first vaccines EU were conditional. food labeling, either. EU, claims main sources authorization claim humans; double-blind placebo. RCTs therefore do qualify determining Food Safety Authority (EFSA), ones highest quality Within category, levels distinguished, starting fully RCT control. They (epidemiological) sub-classified according cohort studies. Then understand mechanisms ingredient brings about effect. next step order beneficial effect, EFSA deems specific effect occurs (an improvement body, reduction factor disease, etc.). causally responsible precisely identified. unequivocally Hence, relating foods admissible. Instead, present determined. centrality consequences: market; companies motivated develop identified accordance Critics reduced so foods, used. substance's mode action information) ought confirmation effects, though difficult ascertain RCT. Scientists critical nutrition, emphasizing differences drugs food. Certain nutrition—such doses, continuous long periods, etc.—mean useful differ (Biesalski Hendrickx, 2013). Faced notion single methodology, EBM, accept methodological pluralism tackle challenge nutrition. critics' As former examples, Defendants guarantee reliable false consumers point view upheld critics. regulation's too probably leads number negatives. negatives, labels such, detriment 2017). While prioritize potential misinformation, aspire wide range labeled healthy not. evolution latter undergone changes. as: need compatible freedom expression, improve consumer understanding latest how dietary choices affect changed, altered, accepts qualified (Sanz Merino 2021). Regulatory aim: making.3 unhindered practical constraints image embodied “social contract science.” analysts differentiate science. natures; deadlines completion research, policy-related background framework, role agencies, pressures interest groups. Jasanoff (1990, 1995) differentiates respect objectives, institutions, frames, well assessing claims. my view, principal (as opposed science) are: advice involvement (government institutions). remainder flow characteristics. differences; i.e., nature, grounding hypotheses, standpoints subject: science's norms acting (Betz, 2013; Cox, Dorato, 2004; Laudan, 1984, Mitchell, 2004); decision-making effectively (Cranor, 1995, 1997; Douglas, Steel, Wandall, 2004). appeals existence explicitly implicitly assumed, standpoint. defend standpoint, I concept policy. Epistemic research: pertinent proof, select appropriate, backing assertions opt hierarchy, specifying value latter, tantamount decisions. Controversies construed reconstructed) Thus, when occur. risks, greater precautionary demanding terms required support product. Those concerned impose attributed grounded. We characterize monistic, respectively. drugs, stance drug substitution. aims maximize guarantees drug's effectiveness, availability, circumstances. being fundamental, we seen, official seeks protect incorrect information, seek recognized labeling. Changes (a objectives) three identified: monistic difference either monism pluralism, technology policies, albeit specifically technology. merely currently government regulation) commission talking advising (regulations policies). anticipate unintended consequences. Our much narrower problem addressed possible, hence body determines options. decisive policy, reflected chosen hierarchy. What glean aforementioned discussion regula