Moral Realism and Political Decisions. Practical Rationality in Contemporary Public Contexts

The challenge of realism is one of the common features of current philosophical debates, across different cultural traditions, and in many areas of investigation (epistemology, metaphysics, ethics, aesthetics, theory of action, etc.). The implications of realism for political philosophy and political practice, though, are just starting to become an object of systematic discussions. Such implications, however, are significant, since the area of politics is contiguous with that of ethics and action, for example. This volume intends to contribute to debates on the relevance of realism – especially moral realism – for politics. The essays included in the collection address a number of related issues, ranging from foundational problems of realism in ethics, action theory and politics, to questions about pragmatics, to difficulties in political theory, and to political hindrances related to economics and legal theory. The common focus of all essays is the relevance of realism for a conception of practical rationality in political contexts.Die Herausforderungen, vor die uns der Realismus stellt, sind in aktuellen philosophischen Debatten gegenwärtig und sie machen sich durch unterschiedliche kulturelle Traditionen und viele Untersuchungsbereiche (Erkenntnistheorie, Metaphysik, Ethik, Ästhetik, Handlungstheorie, etc.) hindurch bemerkbar. Die Auswirkungen des Realismus auf die Politische Philosophie und die politische Praxis sind jedoch erst seit kurzem Gegenstand systematischer Diskussionen, obwohl sie von Bedeutung sind, denn letztlich steht der Bereich der Politik immer in einem Zusammenhang mit Fragen der Ethik und der Handlung. Dieser Band möchte einen Beitrag zu den Debatten über die Relevanz des Realismus für die Politik leisten und hat dabei insbesondere den moralischen Realismus im Blick. Die hier versammelten Aufsätze enthalten eine Reihe von Auseinandersetzungen mit damit zusammenhängenden Problemstellungen, die von grundlegenden Problemen des Realismus in der Ethik, Handlungstheorie und Politik, Fragen zur Pragmatik, über die Schwierigkeiten der Politischen Theorie, bis hin zu politischen Hindernissen für Wirtschaft und Recht reichen. Der gemeinsame Fokus aller Aufsätze liegt dabei in der Betrachtung der Relevanz eines Realismus‘ für eine Konzeption einer praktischen Vernunft im politischen Kontext

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

Political anthropology: biology, culture, and ethics

This chapter distinguishes two anthropological sources of human action and normativity: whilst the \u2018classical\u2019 paradigm claimed teleological, value-centred visions of the human, the \u2018modern\u2019 anthropological paradigm finds support in evolutionary theory and the naturalism of Scientific Darwinism. The authors argue that evolutionary theory is not bound to an evolutionary outlook but can actually integrate elements of normativity typical of the classical paradigm. Although evolutionary theory lacks sources of normativity, it is nevertheless compatible with a teleological interpretation of the biosphere and humans. If our evolved cognitive abilities \u2013 as claimed by the modern paradigm \u2013 allow us freedom to choose, one potentiality is to choose the classical paradigm as a normative ideal. Our evolved nature can help us see that our potentialities can be realized in a good way and that the classical paradigm is a suitable alternative to deal with the problems of the modern world that we face as individuals and as societies

Non-typeable Haemophilus influenzae–Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease : a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Background: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with changes in the sputum microbiome, including an increased prevalence of pathogenic bacteria. Vaccination against the most frequent bacteria identified in AECOPD might reduce exacerbation frequency. We assessed the efficacy, safety, and immunogenicity of a candidate vaccine containing surface proteins from non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) in patients with COPD. Methods: This multicentre, randomised, observer-blinded, placebo-controlled, proof-of-concept, phase 2b trial recruited patients with stable COPD, moderate-to-very severe airflow limitation (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage 2, 3, or 4), at 67 clinical sites in Belgium, Canada, France, Germany, Italy, Spain, UK, and USA. Eligible patients were aged 40-80 years and had a history of at least one moderate or severe exacerbation in the previous year. Patients were allocated (1:1) using a minimisation algorithm to receive two intramuscular injections of NTHi-Mcat vaccine or placebo 60 days apart, in addition to standard care. The allocation algorithm considered age category, number of previous exacerbations, COPD severity at study entry, and country as minimisation factors, to guarantee treatment balance within each factor. Vaccine recipients and those responsible for evaluating study endpoints were masked to group allocation. In the analysis of efficacy, the primary outcome was the rate of any moderate or severe AECOPD occurring within a 1-year period, starting 1 month after the second dose in patients who received two vaccine doses (modified total vaccinated cohort). Safety was assessed in the total vaccinated cohort. The trial is registered with ClinicalTrials.gov, number NCT03281876, and is complete. Findings: Between Nov 27, 2017, and Nov 30, 2018, 606 adults were enrolled and included in the total vaccinated cohort (304 in the NTHi-Mcat vaccine group, 302 in the placebo group); 571 received two doses and were included in the primary efficacy analysis (279 in the NTHi-Mcat vaccine group, 292 in the placebo group). 23 participants dropped-out in the NTHi-Mcat vaccine group and 39 in the placebo group; this included 4 patients in the NTHi-Mcat vaccine group and 15 in the placebo group who withdrew from the study because of an adverse event. The primary analysis included 340 exacerbations (in follow-up time 102 123 days) in the NTHi-Mcat vaccine group and 333 (in 104 443 days) in the placebo group, with a yearly rate of moderate or severe AECOPD of 1·22 in the NTHi-Mcat vaccine group and 1·17 in the placebo group, with vaccine efficacy in reducing the yearly rate of moderate or severe AECOPD estimated to be zero (vaccine efficacy point estimate 2·26% [87% CI -18·27 to 11·58]; p=0·82). Solicited local adverse events were more frequent in the NTHi-Mcat vaccine group (216 [72%] of 301 patients) than with placebo (34 [11%] of 299 patients), and the frequency of solicited general adverse events was similar between groups (239 [79%] of 301 vs 235 [79%] of 299 patients). There was one death in the NTHi-Mcat vaccine group (acute respiratory failure, not related to vaccination) and ten in the placebo group (seven due in part to COPD or respiratory failure). There were 158 serious adverse events (89 [29%] of 304 patients) in the NTHi-Mcat vaccine group, not related to vaccination, and 214 (99 [33%] of 302 patients) in the placebo group. Interpretation: NTHi-Mcat vaccine administered to patients with COPD did not show efficacy in reducing the yearly rate of moderate or severe exacerbations. No safety concerns were identified