Regulating Food and Drug Companies Privately: A View of Lanham Act Cases Brought Against FDA-Regulated Products

The Lanham Act provides a flexible self-help remedy to food and drug companies that are harmed by unfair competition in the marketplace. But is it desirable for private litigation to become the de facto regulation of the industry? In an FDA regulation concerning a warning on OTC drug labels, the agency asserted that “it is in the best interest of the consumer, industry, and the marketplace to have uniformity in presentation and clarity of message.â€99 However, increased regulation through private litigation can send a muddled and inconsistent message to food and drug companies. Private companies have their business interests in mind, and may even ask for damages. This is why the role of the FDA enforcement cannot be pushed aside, or replaced by private litigation. Although many of the cases discussed herein involved disputes over product claims that did not place public health at risk, ensuring truthful labeling and advertising for food and drugs nevertheless plays a vital role in protecting public health and safety

Predictive factors of success at the French National Ranking Examination (NRE) : a retrospective study of the student performance from a French medical school

Background The national ranking examination (NRE) marks the end of the second cycle (6th university year) of French medical studies and ranks students allowing them to choose their specialty and city of residency. We studied the potential predictive factors of success at the 2015 NRE by students attending a French School of Medicine. Methods From March 2016 to March 2017, a retrospective study of factors associated with the 2015 NRE success was conducted and enrolled 242 students who attended their sixth year at the school of medicine of Reims. Demographic and academic data collected by a home-made survey was studied using univariate and then multivariate analysis by generalized linear regression with a threshold of p <  0.05 deemed significant. Results The factors independently associated with a better ranking at the NRE were the motivation for the preparation of the NRE (gain of 3327 ± 527 places, p <  0.0001); to have participated in the NRE white test organized by la Revue du Praticien in November 2014 (gain of 869 ± 426 places, p <  0.04), to have participated in the NRE white test organized by la conférence Hippocrate in March 2015 (+ 613 places ±297, p <  0.04). The factors independently associated with poor NRE ranking were repeating the first year (loss of 1410 places ±286, p <  0.0001), repeating a year during university course (loss of 1092 places ±385, p <  0.005), attendance of hospital internships in 6th year (loss of 706 places ±298, p <  0.02). Conclusions The student motivation and their white tests completion were significantly associated with success at the NRE. Conversely, repeating a university year during their course and attendance of 6th year hospital internships were associated with a lower ranking

Thermally activated magnetization reversal in bulk BiFe0.5Mn0.5O3

We report on the synthesis and characterization of BiFe0.5Mn0.5O3, a potential type-I multiferroic compound displaying temperature induced magnetization reversal. Bulk samples were obtained by means of solid state reaction carried out under the application of hydrostatic pressure at 6 GPa and 1100{\deg}C. The crystal structure is an highly distorted perovskite with no cation order on the B site, where, besides a complex scheme of tilt and rotations of the TM-O6 octahedra, large off-centering of the bismuth ions is detected. Below T1 = 420 K the compound undergoes a first weak ferromagnetic transition related to the ordering of iron rich clusters. At lower temperatures (just below RT) two distinct thermally activated mechanisms are superimposed, inducing at first an enhancement of the magnetization at T2 = 288 K, then a spontaneous reversal process centered at T3 = 250 K, finally giving rise to a negative response. The application of fields higher than 1500 Oe suppresses the process, yielding a ferromagnetic like behaviour. The complementary use of SQuID magnetometry and M\"ossbauer spectroscopy allowed the interpretation of the overall magnetic behaviour in terms of an uncompensated weak competitive coupling between non-equivalent clusters of interactions characterized by different critical temperatures and resultant magnetizations. PACS numbers: 75.85.+t, 75.60.Jk, 76.80.+y, 75.30.Et, 75.30.KzComment: 30 pages, 13 figure

New materials for Li-ion batteries : synthesis and spectroscopic characterization of Li2(FeMnCo) SiO4 cathode materials

Improving cathode materials is mandatory for next-generation Li-ion batteries. Exploring polyanion compounds with high theoretical capacity such as the lithium metal orthosilicates, Li2MSiO4 is of great importance. In particular, mixed silicates represent an advancement with practical applications. Here we present results on a rapid solid state synthesis of mixed Li2(FeMnCo)SiO4 samples in a wide compositional range. The solid solution in the P21/n space group was found to be stable for high iron concentration or for a cobalt content up to about 0.3 atom per formula unit. Other compositions led to a mixture of polymorphs, namely Pmn21 and Pbn21. All the samples contained a variable amount of Fe3+ ions that was quantified by Mössbauer spectroscopy and confirmed by the TN values of the paramagnetic to antiferromagnetic transition. Preliminary characterization by cyclic voltammetry revealed the effect of Fe3+ on the electrochemical response. Further work is required to determine the impact of these electrode materials on lithium batteries

EEG-based mental workload neurometric to evaluate the impact of different traffic and road conditions in real driving settings

Car driving is considered a very complex activity, consisting of different concomitant tasks and subtasks, thus it is crucial to understand the impact of different factors, such as road complexity, traffic, dashboard devices, and external events on the driver’s behavior and performance. For this reason, in particular situations the cognitive demand experienced by the driver could be very high, inducing an excessive experienced mental workload and consequently an increasing of error commission probability. In this regard, it has been demonstrated that human error is the main cause of the 57% of road accidents and a contributing factor in most of them. In this study, 20 young subjects have been involved in a real driving experiment, performed under different traffic conditions (rush hour and not) and along different road types (main and secondary streets). Moreover, during the driving tasks different specific events, in particular a pedestrian crossing the road and a car entering the traffic flow just ahead of the experimental subject, have been acted. A Workload Index based on the Electroencephalographic (EEG), i.e., brain activity, of the drivers has been employed to investigate the impact of the different factors on the driver’s workload. Eye-Tracking (ET) technology and subjective measures have also been employed in order to have a comprehensive overview of the driver’s perceived workload and to investigate the different insights obtainable from the employed methodologies. The employment of such EEG-based Workload index confirmed the significant impact of both traffic and road types on the drivers’ behavior (increasing their workload), with the advantage of being under real settings. Also, it allowed to highlight the increased workload related to external events while driving, in particular with a significant effect during those situations when the traffic was low. Finally, the comparison between methodologies revealed the higher sensitivity of neurophysiological measures with respect to ET and subjective ones. In conclusion, such an EEG-based Workload index would allow to assess objectively the mental workload experienced by the driver, standing out as a powerful tool for research aimed to investigate drivers’ behavior and providing additional and complementary insights with respect to traditional methodologies employed within road safety research

Decreased insulin secretion and increased risk of type 2 diabetes associated with allelic variations of the WFS1 gene: the Data from Epidemiological Study on the Insulin Resistance Syndrome (DESIR) prospective study

We investigated associations of allelic variations in the WFS1 gene with insulin secretion and risk of type 2 diabetes in a general population prospective study.We studied 5,110 unrelated French men and women who participated in the prospective Data from Epidemiological Study on the Insulin Resistance Syndrome (DESIR) study. Additional cross-sectional analyses were performed on 4,472 French individuals with type 2 diabetes and 3,065 controls. Three single nucleotide polymorphisms (SNPs) were genotyped: rs10010131, rs1801213/rs7672995 and rs734312.We observed statistically significant associations between the major alleles of the three variants and prevalent type 2 diabetes in the DESIR cohort at baseline. Cox analyses showed an association between the G-allele of rs10010131 and incident type 2 diabetes (HR 1.34, 95% CI 1.08-1.70, p = 0.007). Similar results were observed for the G-allele of rs1801213 and the A-allele of rs734312. the GGA haplotype was associated with an increased risk of diabetes as compared with the ACG haplotype (HR 1.26, 95% CI 1.04-1.42, p = 0.02). We also observed statistically significant associations of the three SNPs with plasma glucose, HbA(1c) levels and insulin secretion at baseline and throughout the study in individuals with type 2 diabetes or at risk of developing diabetes. However, no association was observed in those who remained normoglycaemic at the end of the follow-up. Associations between the three variants and type 2 diabetes were replicated in cross-sectional studies of type 2 diabetic patients in comparison with a non-diabetic control group.The most frequent haplotype at the haplotype block containing the WFS1 gene modulated insulin secretion and was associated with an increased risk of type 2 diabetes.Societe Francophone du Diabete (SFD - Alfediam)Association Diabete Risque Vasculaire (ADRV), FranceCoordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)INSERMCNAMTSLillyNovartis PharmaSanofi-AventisINSERM (Reseaux en Sante Publique, Interactions entre les determinants de la sante)Association Diabete Risque VasculaireFederation Francaise de CardiologieLa Fondation de FranceALFEDIAMONIVINSArdix MedicalBayer DiagnosticsBecton DickinsonCardionicsMerck SanteNovo NordiskPierre FabreRocheTopconUniv Paris 07, INSERM, Res Unit 695, F-75018 Paris, FranceFed Univ Hlth Sci Porto Alegre, Postgradut Program Hlth Sci, Porto Alegre, RS, BrazilUniversidade Federal de São Paulo, Mol Endocrinol Lab, São Paulo, BrazilAssistance Publ Hop Paris Cochin Hosp, Dept Immunol & Diabetol, Paris, FranceUniv Paris 05, UFR Med, Paris, FranceUniv Paris 07, UFR Med, Paris, FranceAssistance Publ Hop Paris Bichat Hosp, Dept Endocrinol Diabetol & Nutr, Paris, FranceInst Inter Reg Sante IRSA, La Riche, FranceINSERM, U1018, CESP, Ctr Res Epidemiol & Populat Hlth, Villejuif, FranceUniv Paris 11, UMRS 1018, Villejuif, FranceUniversidade Federal de São Paulo, Mol Endocrinol Lab, São Paulo, BrazilCAPES: 1798-09-0Web of Scienc

Contemplative Practices and Mental Training: Prospects for American Education

This article draws on research in neuroscience, cognitive science, developmental psychology, and education, as well as scholarship from contemplative traditions concerning the cultivation of positive development, to highlight a set of mental skills and socioemotional dispositions that are central to the aims of education in the 21st century. These include self‐regulatory skills associated with emotion and attention, self‐representations, and prosocial dispositions such as empathy and compassion. It should be possible to strengthen these positive qualities and dispositions through systematic contemplative practices, which induce plastic changes in brain function and structure, supporting prosocial behavior and academic success in young people. These putative beneficial consequences call for focused programmatic research to better characterize which forms and frequencies of practice are most effective for which types of children and adolescents. Results from such research may help refine training programs to maximize their effectiveness at different ages and to document the changes in neural function and structure that might be induced.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/92125/1/cdep240.pd

Review of Research on Tire–Pavement Contact Behavior

This article presents the latest progress in research on tire–pavement contact behavior. Firstly, the tire–pavement contact characteristics and their influencing factors are summarized. Then, the measurement methods and theoretical research on tire–pavement contact behavior are reviewed, and the advantages and shortcomings of different methods are compared and analyzed. Finally, analysis in the field of pavement engineering is summarized based on contact behavior. This article suggests a few key research directions: Tire–pavement contact behavior is influenced by multiple factors; therefore, multi-physical field-coupling analyses need to be carried out. Tire–pavement contact tests are mostly static and non-standardized, and it is a future trend to develop high-precision, low-cost, and standardized instruments that can measure dynamic contact. Theoretical research models rarely involve environmental factors; a contact model of the tire, pavement, and environment needs to be constructed that can truly describe the contact process. There is a relationship between contact characteristics and pavement performance; pavement performance evaluation indexes need to be established based on tire–pavement contact characteristics in the future