Law, Market Building and Public Health in the European Union

European Union (EU) law is based upon a liberalising imperative, the goal of which is to construct a single market between member states. Yet the EU is no ordinary trade pact, incorporating as it does a range of supranational political institutions and common policies in a range of areas beyond simple market building. Scholars have nevertheless noted a distinction between ‘positive’ integration (the formulation of common policies applying to all member states) and ‘negative’ integration (the removal of national-level regulations acting as barriers to market integration). In the context of debates about the implications of trade law and corporate activity for health, this article poses three related questions. First, to what extent does EU law afford corporations opportunities to challenge national-level health regulations? Second, to what extent do EU legal and political processes provide opportunities for positive pro-health supranational regulation, including that which might offset the effects of negative liberalising integration? Third, how do EU market-building processes differ from those of more narrowly-drawn trade agreements and organisations in their implications for health? We analyse and compare two recent sets of health-related legal proceedings under EU law, the first of which challenges legislation passed by the Scottish Government to introduce minimum unit pricing for alcohol, and the second of which addresses the legality of specific aspects of the EU’s 2014 Tobacco Products Directive. We find, first, that EU law offers ample opportunities for corporations to challenge national health regulations; second, that there is significant scope for pro-health supranational regulations, but that these must be couched in the language of facilitating the single market, and are dependent on the political commitment of key policy actors; and, third, that this (limited) scope for pro-health supranational regulation distinguishes EU legal and political processes from those of other trade agreements and organisations

Starch-gelatin antimicrobial packaging materials to extend the shelf life of chicken breast fillets

[EN] Antimicrobial starch:gelatin (1:1) films containing N-¿-lauroyl-l-arginine ethyl ester monohydrochloride (LAE) (10 % wt.) were used as food contact active layers in chicken breast fillets vacuum-packaged in polyamide/polyethylene pouches. Active layers were thermoprocessed (TP) or cast (OC) on the plastic film. Oxidized starch was used in OC coatings. Packaged chicken breast samples were stored at 4¿°C and their physicochemical properties (pH, colour and lipid oxidation) and microbial quality were analysed throughout storage. Both TP and OC films significantly (p¿<¿0.05) extended the shelf life of chicken breast fillets compared to control samples. The starch oxidation reaction in OC films promoted the formation of Maillard reaction compounds in the starch-gelatine blends, which enhanced the antimicrobial effectiveness of the OC films, but also promoted oxidative processes. This greatly affected the pH and colour parameters in OC packaged samples. Therefore, TP blend films containing LAE are recommended since they effectively extended the shelf life of chicken breast fillets without affecting the meat oxidation.The authors acknowledge the financial support provided by Ministerio de Economia y Competividad (Projects AGL2016-76699-R and AGL2013-42989-R). Olga Moreno Marro also thanks the Ministerio de Educacion, Cultura y Deporte for the FPU 2012-1121 grant.Moreno Marro, O.; Atarés Huerta, LM.; Chiralt, A.; Cruz-Romero, MC.; Kerry, J. (2018). Starch-gelatin antimicrobial packaging materials to extend the shelf life of chicken breast fillets. LWT - Food Science and Technology. 97:483-490. https://doi.org/10.1016/j.lwt.2018.07.005S4834909

Aqueous tear assessment in dogs: Impact of cephalic conformation, inter‐test correlations, and test‐retest repeatability

Objective - To characterize diagnostic findings, test‐retest repeatability, and correlations among lacrimal tests in dogs of diverse cephalic conformations. Animal studied - Fifty healthy dogs (25 brachycephalic, 25 nonbrachycephalic). Procedures - A series of diagnostics were performed in each dog, allowing for a 10‐minute interval between tests and repeating each test 24 hours later under similar conditions: corneal tactile sensation (CTS), strip meniscometry test (SMT), phenol red thread test (PRTT), endodontic absorbent paper point tear test (EAPPTT), Schirmer tear test‐1 without (STT‐1) or with nasolacrimal stimulation (NL‐STT1), and Schirmer tear test‐2 (STT‐2). Results - Mean ± SD test values were lower in brachycephalic vs. nonbrachycephalic dogs (except for SMT; 7.4 ± 2.0 mm/5 seconds vs 7.3 ± 2.4 mm/5 seconds), with statistically significant differences noted for CTS (1.8 ± 0.5 cm vs 3.4 ± 0.8 cm), PRTT (37.2 ± 4.0 mm/15 seconds vs 41.1 ± 5.5 mm/15 seconds), STT‐1 (20.1 ± 3.4 mm/min vs 23.3 ± 5.7 mm/min), STT‐2 (13.0 ± 3.4 mm/min vs 16.9 ± 3.9 mm/min), and NL‐STT1 (23.2 ± 3.6 mm/min vs 27.1 ± 5.4 mm/min), and nonsignificant differences for EAPPTT (16.6 ± 2.7 mm/15 seconds vs 17.5 ± 2.9 mm/15 seconds). Nasolacrimal stimulation increased STT‐1 values by 18% on average. Correlations among tests were generally weak to moderate (r \u3c .70) except for a strong correlation between STT‐1 and NL‐STT1 (r = .83, P \u3c .001). Test reliability was good although test‐retest repeatability was generally poor to moderate, as depicted by low intraclass correlation coefficients (ICC ≤ 0.75) and wide 95% limits of agreement, except for CTS (ICC = 0.91). Conclusions - Corneal sensitivity and aqueous tear secretion are lower in brachycephalic dogs. A comprehensive assessment of the ocular surface requires the combination of several diagnostic tests. The nasolacrimal reflex may provide a useful diagnostic and therapeutic tool in dogs

Characterization of Microbialites and Microbial Mats of the Laguna Negra Hypersaline Lake (Puna of Catamarca, Argentina)

Microbial carbonates provide an invaluable tool to understand biogeochemical processes in aqueous systems, especially in lacustrine and marine environments. Lakes are strongly sensitive to climatically driven environmental changes, and microbialites have recently been shown to provide a record of these changes. Unraveling physicochemical and microbiological controls on carbonates textures and geochemistry is necessary to correctly interpret these signals and the microbial biosphere record within sedimentary carbonates. The Laguna Negra is a high-altitude hypersaline Andean lake (Puna of Catamarca, Argentina), where abundant carbonate precipitation takes place and makes this system an interesting example that preserves a spectrum of carbonate fabrics reflecting complex physical, chemical, and biological interactions. The extreme environmental conditions (high UV radiation, elevated salinity, and temperature extremes) make the Laguna Negra a good analogue to some Precambrian microbialites (e.g., Tumbiana Fm., Archean, Australia). In addition, the discovery of ancient evaporating playa-lake systems on Mars’ surface (e.g., ShalbatanaVallis, Noachian, Mars) highlights the potential of Laguna Negra to provide insight into biosignature preservation in similar environments, in both terrestrial and extraterrestrial settings, given that microbial processes in the Laguna Negra can be studied with remarkable detail.Fil: Boidi, Flavia Jaquelina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Centro de Investigaciones en Ciencias de la Tierra. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas Físicas y Naturales. Centro de Investigaciones en Ciencias de la Tierra; ArgentinaFil: Mlewski, Estela Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Centro de Investigaciones en Ciencias de la Tierra. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas Físicas y Naturales. Centro de Investigaciones en Ciencias de la Tierra; ArgentinaFil: Gomez, Fernando Javier. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Centro de Investigaciones en Ciencias de la Tierra. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas Físicas y Naturales. Centro de Investigaciones en Ciencias de la Tierra; ArgentinaFil: Gérard, Emmanuelle. Centre National de la Recherche Scientifique; Franci

Rapid, reliable, and reproducible molecular sub-grouping of clinical medulloblastoma samples

The diagnosis of medulloblastoma likely encompasses several distinct entities, with recent evidence for the existence of at least four unique molecular subgroups that exhibit distinct genetic, transcriptional, demographic, and clinical features. Assignment of molecular subgroup through routine profiling of high-quality RNA on expression microarrays is likely impractical in the clinical setting. The planning and execution of medulloblastoma clinical trials that stratify by subgroup, or which are targeted to a specific subgroup requires technologies that can be economically, rapidly, reliably, and reproducibly applied to formalin-fixed paraffin embedded (FFPE) specimens. In the current study, we have developed an assay that accurately measures the expression level of 22 medulloblastoma subgroup-specific signature genes (CodeSet) using nanoString nCounter Technology. Comparison of the nanoString assay with Affymetrix expression array data on a training series of 101 medulloblastomas of known subgroup demonstrated a high concordance (Pearson correlation r = 0.86). The assay was validated on a second set of 130 non-overlapping medulloblastomas of known subgroup, correctly assigning 98% (127/130) of tumors to the appropriate subgroup. Reproducibility was demonstrated by repeating the assay in three independent laboratories in Canada, the United States, and Switzerland. Finally, the nanoString assay could confidently predict subgroup in 88% of recent FFPE cases, of which 100% had accurate subgroup assignment. We present an assay based on nanoString technology that is capable of rapidly, reliably, and reproducibly assigning clinical FFPE medulloblastoma samples to their molecular subgroup, and which is highly suited for future medulloblastoma clinical trials

COVID-19-associated hyperinflammation and escalation of patient care: a retrospective longitudinal cohort study

Background: A subset of patients with severe COVID-19 develop a hyperinflammatory syndrome, which might contribute to morbidity and mortality. This study explores a specific phenotype of COVID-19-associated hyperinflammation (COV-HI), and its associations with escalation of respiratory support and survival. / Methods: In this retrospective cohort study, we enrolled consecutive inpatients (aged ≥18 years) admitted to University College London Hospitals and Newcastle upon Tyne Hospitals in the UK with PCR-confirmed COVID-19 during the first wave of community-acquired infection. Demographic data, laboratory tests, and clinical status were recorded from the day of admission until death or discharge, with a minimum follow-up time of 28 days. We defined COV-HI as a C-reactive protein concentration greater than 150 mg/L or doubling within 24 h from greater than 50 mg/L, or a ferritin concentration greater than 1500 μg/L. Respiratory support was categorised as oxygen only, non-invasive ventilation, and intubation. Initial and repeated measures of hyperinflammation were evaluated in relation to the next-day risk of death or need for escalation of respiratory support (as a combined endpoint), using a multi-level logistic regression model. / Findings: We included 269 patients admitted to one of the study hospitals between March 1 and March 31, 2020, among whom 178 (66%) were eligible for escalation of respiratory support and 91 (34%) patients were not eligible. Of the whole cohort, 90 (33%) patients met the COV-HI criteria at admission. Despite having a younger median age and lower median Charlson Comorbidity Index scores, a higher proportion of patients with COV-HI on admission died during follow-up (36 [40%] of 90 patients) compared with the patients without COV-HI on admission (46 [26%] of 179). Among the 178 patients who were eligible for full respiratory support, 65 (37%) met the definition for COV-HI at admission, and 67 (74%) of the 90 patients whose respiratory care was escalated met the criteria by the day of escalation. Meeting the COV-HI criteria was significantly associated with the risk of next-day escalation of respiratory support or death (hazard ratio 2·24 [95% CI 1·62–2·87]) after adjustment for age, sex, and comorbidity. / Interpretation: Associations between elevated inflammatory markers, escalation of respiratory support, and survival in people with COVID-19 indicate the existence of a high-risk inflammatory phenotype. COV-HI might be useful to stratify patient groups in trial design. / Funding: None

Height and timing of growth spurt during puberty in young people living with vertically acquired HIV in Europe and Thailand.

OBJECTIVE: The aim of this study was to describe growth during puberty in young people with vertically acquired HIV. DESIGN: Pooled data from 12 paediatric HIV cohorts in Europe and Thailand. METHODS: One thousand and ninety-four children initiating a nonnucleoside reverse transcriptase inhibitor or boosted protease inhibitor based regimen aged 1-10 years were included. Super Imposition by Translation And Rotation (SITAR) models described growth from age 8 years using three parameters (average height, timing and shape of the growth spurt), dependent on age and height-for-age z-score (HAZ) (WHO references) at antiretroviral therapy (ART) initiation. Multivariate regression explored characteristics associated with these three parameters. RESULTS: At ART initiation, median age and HAZ was 6.4 [interquartile range (IQR): 2.8, 9.0] years and -1.2 (IQR: -2.3 to -0.2), respectively. Median follow-up was 9.1 (IQR: 6.9, 11.4) years. In girls, older age and lower HAZ at ART initiation were independently associated with a growth spurt which occurred 0.41 (95% confidence interval 0.20-0.62) years later in children starting ART age 6 to 10 years compared with 1 to 2 years and 1.50 (1.21-1.78) years later in those starting with HAZ less than -3 compared with HAZ at least -1. Later growth spurts in girls resulted in continued height growth into later adolescence. In boys starting ART with HAZ less than -1, growth spurts were later in children starting ART in the oldest age group, but for HAZ at least -1, there was no association with age. Girls and boys who initiated ART with HAZ at least -1 maintained a similar height to the WHO reference mean. CONCLUSION: Stunting at ART initiation was associated with later growth spurts in girls. Children with HAZ at least -1 at ART initiation grew in height at the level expected in HIV negative children of a comparable age

Veterinary students' usage and perception of video teaching resources

<p>Abstract</p> <p>Background</p> <p>The purpose of our study was to use a student-centred approach to develop an online video learning resource (called 'Moo Tube') at the School of Veterinary Medicine and Science, University of Nottingham, UK and also to provide guidance for other academics in the School wishing to develop a similar resource in the future.</p> <p>Methods</p> <p>A focus group in the format of the nominal group technique was used to garner the opinions of 12 undergraduate students (3 from year-1, 4 from year-2 and 5 from year-3). Students generated lists of items in response to key questions, these responses were thematically analysed to generate key themes which were compared between the different year groups. The number of visits to 'Moo Tube' before and after an objective structured practical examination (OSPE) was also analysed to provide data on video usage.</p> <p>Results</p> <p>Students highlighted a number of strengths of video resources which can be grouped into four overarching themes: (1) teaching enhancement, (2) accessibility, (3) technical quality and (4) video content. Of these themes, students rated teaching enhancement and accessibility most highly. Video usage was seen to significantly increase (P < 0.05) prior to an examination and significantly decrease (P < 0.05) following the examination.</p> <p>Conclusions</p> <p>The students had a positive perception of video usage in higher education. Video usage increases prior to practical examinations. Image quality was a greater concern with year-3 students than with either year-1 or 2 students but all groups highlighted the following as important issues: i) good sound quality, ii) accessibility, including location of videos within electronic libraries, and iii) video content. Based on the findings from this study, guidelines are suggested for those developing undergraduate veterinary videos. We believe that many aspects of our list will have resonance in other areas of medicine education and higher education.</p