Offshoring Clinical Trials: The Mutable Ethics, Weak Protections and Vulnerable Subjects of EU Law

In this paper I engage with science and technology studies work on pharmaceuticalisation to explore how European Union (EU) law helps to produce and support the preference for pharmaceutical responses in public health governance, while authorising the production of vulnerable subjects through the growing off-shoring of clinical trials. Drawing on the analysis of legal and policy documents, I demonstrate how EU law allows and legitimates the use of data procured from vulnerable subjects abroad for market authorisation and corporate profitability at home. This is possible because the EU has (de)selected international ethical frameworks in order to support the continued and growing use of clinical trials data from abroad. This has helped to stimulate the revision of international ethical frameworks in light of market needs, inscribing EU public health law within specific politics (that often remained obscured by the joint workings of legal and technological discourses). I suggest that law operates as part of a broader ‘technology’ – encompassing ethics and human rights discourses – that functions to optimise life through resort to market reasoning. Law is thereby reoriented, instrumentalised and deployed as part of a broader project aimed at (re)defining and limiting the boundaries of the EU's responsibility for public health, including the broader social production of public health problems and the unequal global order that the EU represents and helps to depoliticise and perpetuate. Overall, this limits the EU's responsibility and accountability for these failures, as well as another: the weak and mutable protections and insecure legacies for vulnerable trial subjects abroad.

Multidisciplinary Teamwork in Autism: Can One Size Fit All?

Multidisciplinary practice has become an accepted approach in many education and social and health care fields. In fact, the right to a multidisciplinary assessment is enshrined in the United Nations Convention of the Rights for Persons with Disabilities (United Nations, 2007). In order to avert a 'one size fits all' response to particularly heterogeneous diagnoses, such as autism spectrum disorders (ASD), the National Institute for Clinical Excellence (NICE) recommends multidisciplinary input. Yet, multidisciplinarity lacks empirical evidence of effectiveness, is fraught with conceptual difficulties and methodological incompatibilities, and therefore there is a danger of resorting to an ill-defined eclectic 'hodgepodge' of interventions. Virtually all evidence-based interventions in autism and intellectual disabilities are behaviourally based. Not surprisingly, therefore, professionals trained in behaviour analysis to international standards are increasingly becoming key personnel in multidisciplinary teams. In fact, professionals from a range of disciplines seek training in behaviour analysis. In this article we brought together a multidisciplinary group of professionals from education, health, and social care, most of whom have a dual qualification in an allied health, social care, or educational profession, as well as in behaviour anlaysis. Together we look at the initial training in these professions and explore how behaviour analysis can offer a common and coherent conceptual framework for true multidisciplinarity, based on sound scientific knowledge about behaviour, without resort to reifying theories. We illustrate how this unifying approach can enhance evidence-based multidisciplinary practice so that 'one size' will fit all. Copyright © Australian Psychological Society Ltd 2014.

Clinical Trials Abroad: The Marketable Ethics, Weak Protections and Vulnerable Subjects of EU Law

This chapter explores how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to pharmaceuticals as a fix for public health problems. This is made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections for the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.

Urban planning after the Black Death: townscape transformations in later-medieval England (1350-1530)

This article offers a reconsideration of planning and development in
English towns and cities after the Black Death (1348). Conventional historical
accounts have stressed the occurrence of urban ‘decay’ in the later fourteenth and fifteenth centuries. Here, instead, a case is made that after 1350 urban planning continued to influence towns and cities in England through the transformation of their townscapes. Using the conceptual approaches of urban morphologists in particular, the article demonstrates that not only did the foundation of new towns and creation of new suburbs characterize the period 1350–1530, but so too did the redevelopment of existing urban landscapes through civic improvements and public works. These reveal evidence for the particular ‘agents of change’ involved in the planning and development process, such as surveyors, officials, patrons and architects, and also the role played by maps and drawn surveys. In this reappraisal, England’s urban experiences can be seen to have been closely connected with those instances of urban planning after the Black Death occurring elsewhere in contemporary continental Europe.

Efficient Marginal Likelihood Computation for Gaussian Process Regression

In a Bayesian learning setting, the posterior distribution of a predictive model arises from a trade-off between its prior distribution and the conditional likelihood of observed data. Such distribution functions usually rely on additional hyperparameters which need to be tuned in order to achieve optimum predictive performance; this operation can be efficiently performed in an Empirical Bayes fashion by maximizing the posterior marginal likelihood of the observed data. Since the score function of this optimization problem is in general characterized by the presence of local optima, it is necessary to resort to global optimization strategies, which require a large number of function evaluations. Given that the evaluation is usually computationally intensive and badly scaled with respect to the dataset size, the maximum number of observations that can be treated simultaneously is quite limited. In this paper, we consider the case of hyperparameter tuning in Gaussian process regression. A straightforward implementation of the posterior log-likelihood for this model requires O(N^3) operations for every iteration of the optimization procedure, where N is the number of examples in the input dataset. We derive a novel set of identities that allow, after an initial overhead of O(N^3), the evaluation of the score function, as well as the Jacobian and Hessian matrices, in O(N) operations. We prove how the proposed identities, that follow from the eigendecomposition of the kernel matrix, yield a reduction of several orders of magnitude in the computation time for the hyperparameter optimization problem. Notably, the proposed solution provides computational advantages even with respect to state of the art approximations that rely on sparse kernel matrices.

Impact of Residual Transmit RF Impairments on Training-Based MIMO Systems

Radio-frequency (RF) impairments, which intimately exist in wireless communication systems, can severely limit the performance of multiple-input-multiple-output (MIMO) systems. Although we can resort to compensation schemes to mitigate some of these impairments, a certain amount of residual impairments always persists. In this paper, we consider a training-based point-to-point MIMO system with residual transmit RF impairments (RTRI) using spatial multiplexing transmission. Specifically, we derive a new linear channel estimator for the proposed model, and show that RTRI create an estimation error floor in the high signal-to-noise ratio (SNR) regime. Moreover, we derive closed-form expressions for the signal-to-noise-plus-interference ratio (SINR) distributions, along with analytical expressions for the ergodic achievable rates of zero-forcing, maximum ratio combining, and minimum mean-squared error receivers, respectively. In addition, we optimize the ergodic achievable rates with respect to the training sequence length and demonstrate that finite dimensional systems with RTRI generally require more training at high SNRs than those with ideal hardware. Finally, we extend our analysis to large-scale MIMO configurations, and derive deterministic equivalents of the ergodic achievable rates. It is shown that, by deploying large receive antenna arrays, the extra training requirements due to RTRI can be eliminated. In fact, with a sufficiently large number of receive antennas, systems with RTRI may even need less training than systems with ideal hardware.

In the Shadows of the Old Town: Thomas Anna and 19th-century Glasgow

In 1858, a volume entitled Midnight Scenes and Social Photographs – being sketches of life in the streets, wynds and dens of the city of Glasgow was published under the pseudonym of ‘Shadow’ by Alexander Brown, a Glaswegian flâneur and reformer. Its frontispiece is an etching which depicts a theatre-like proscenium arch whose curtains have been withdrawn to reveal to the audience all the poverty, destitution and disorder that one was likely to find after dark in the insalubrious quarters of the city. At the extreme left-hand side, partly obscured by the curtain a silhouetted figure stands behind an unwieldy camera perched on a tripod. Distinctly unaffected by the mêlée, an arm is calmly raised and a finger precisely arched in the moment before the shutter is clicked and the scene committed to record. The volume, however, relies exclusively on textual descriptions to evoke the underside of the city and contains no photographs at all. Instead, the use of the word photograph in the title can be understood as a metaphor for detached scientific objectivity, a quality much celebrated by nineteenth-century reformers and investigators of social ills. As it happened, a decade after Shadow disappeared into the labyrinthine back-lands of Old Town Glasgow, he was followed there by a real photographer. In 1868, Thomas Annan was commissioned by the City Improvements Trust to take photographs of the Old Town in its last moments of existence before it was pulled down under a series of legislative acts. But perhaps paradoxically, given Shadow’s faith in the analytical properties of photography, Annan’s work seems to refute much of the material contained in Midnight Scenes and other similar tracts. Instead of the dens, shebeens, labyrinths and rowdy crowds described by Shadow, Annan’s depictions of the Old Town convey a static, calm environment, one which is often sparsely inhabited by a curious but apparently orderly population.

Taking account of the sensational tendencies of many reformists’ texts, this paper investigates the discrepancies between the two representations, focussing in particular on the constraints which operated on Annan during his commission. It argues that Annan’s compositions – which became very influential on other 19th century photographers of everyday life such as John Thomson or Jacob Riis – far from being dispassionate analytical works, emerged as a result of a matrix of factors which included: photographic and artistic precedents; Annan’s own predilections as a photographer; technological limitations; the nature of the commission from the City Improvements Trust and political climate in which it was given; the medieval urban fabric in which he had to operate; and, perhaps, most importantly, the identity of the Old Towns inhabitants themselves.

Context-dependent Combination of Sensor Information in Dempster-Shafer Theory for BDI

There has been much interest in the belief–desire–intention (BDI) agent-based model for developing scalable intelligent systems, e.g. using the AgentSpeak framework. However, reasoning from sensor information in these large-scale systems remains a significant challenge. For example, agents may be faced with information from heterogeneous sources which is uncertain and incomplete, while the sources themselves may be unreliable or conflicting. In order to derive meaningful conclusions, it is important that such information be correctly modelled and combined. In this paper, we choose to model uncertain sensor information in Dempster–Shafer (DS) theory. Unfortunately, as in other uncertainty theories, simple combination strategies in DS theory are often too restrictive (losing valuable information) or too permissive (resulting in ignorance). For this reason, we investigate how a context-dependent strategy originally defined for possibility theory can be adapted to DS theory. In particular, we use the notion of largely partially maximal consistent subsets (LPMCSes) to characterise the context for when to use Dempster’s original rule of combination and for when to resort to an alternative. To guide this process, we identify existing measures of similarity and conflict for finding LPMCSes along with quality of information heuristics to ensure that LPMCSes are formed around high-quality information. We then propose an intelligent sensor model for integrating this information into the AgentSpeak framework which is responsible for applying evidence propagation to construct compatible information, for performing context-dependent combination and for deriving beliefs for revising an agent’s belief base. Finally, we present a power grid scenario inspired by a real-world case study to demonstrate our work.

The impact of parental migration on health status and health behaviours among left behind adolescent school children in China.

BACKGROUND:

One out of ten of China's population are migrants, moving from rural to urban areas. Many leave their families behind resulting in millions of school children living in their rural home towns without one or both their parents. Little is known about the health status of these left behind children (LBC). This study compares the health status and health-related behaviours of left behind adolescent school children and their counterparts in a rural area in Southern China.

METHODS:

A cross-sectional study was conducted among middle school students in Fuyang Township, Guangdong, China (2007-2008). Information about health behaviours, parental migration and demographic characteristics was collected using a self-administered questionnaire. Overweight/obesity and stunting were defined based on measurements of height and weight. Univariate and multivariate analyses were used to estimate the differences in health outcomes between LBC and non-LBC.

RESULTS:

18.1% of the schoolchildren had one or both parents working away from home. Multivariate analysis showed that male LBC were at higher risk of skipping breakfast, higher levels of physical inactivity, internet addiction, having ever smoked tobacco, suicide ideation, and being overweight. LBC girls were more likely to drink excessive amounts of sweetened beverage, to watch more TV, to have ever smoked or currently smoke tobacco, to have ever drunk alcohol and to binge drinking. They were also more likely to be unhappy, to think of planning suicide and consider leaving home.

CONCLUSIONS:

Our findings suggest that parental migration is a risk factor for unhealthy behaviours amongst adolescent school children in rural China. Further research is required in addition to the consideration of the implications for policies and programmes to protect LBC.

Learning from Outdoor Webcams: Surveillance of Physical Activity Across Environments

Abstract
Publicly available, outdoor webcams continuously view the world and share images. These cameras include traffic cams, campus cams, ski-resort cams, etc. The Archive of Many Outdoor Scenes (AMOS) is a project aiming to geolocate, annotate, archive, and visualize these cameras and images to serve as a resource for a wide variety of scientific applications. The AMOS dataset has archived over 750 million images of outdoor environments from 27,000 webcams since 2006. Our goal is to utilize the AMOS image dataset and crowdsourcing to develop reliable and valid tools to improve physical activity assessment via online, outdoor webcam capture of global physical activity patterns and urban built environment characteristics.
This project’s grand scale-up of capturing physical activity patterns and built environments is a methodological step forward in advancing a real-time, non-labor intensive assessment using webcams, crowdsourcing, and eventually machine learning. The combined use of webcams capturing outdoor scenes every 30 min and crowdsources providing the labor of annotating the scenes allows for accelerated public health surveillance related to physical activity across numerous built environments. The ultimate goal of this public health and computer vision collaboration is to develop machine learning algorithms that will automatically identify and calculate physical activity patterns.

Seaborne trade and the commercialisation of fifteenth- and sixteenth-century Gaelic Ulster

This study considers the frequently stated claim that the economy of Gaelic- speaking lordships in Ulster during the fifteenth and sixteenth centuries was predominately pastoral anduncommercialised, by drawing on a variety of sources not usually combined. It proposes that the increased European demand for fish and the growth of the fish industry across northern Europe played a crucial role in stimulating trade between the coastal areas of Ulster on the one hand, and Britain and continental Europe on the other. This led to the establishment of permanent markets and towns, which joined at least two new inland towns in the southern parts of the province, bringing about a commercial presence in most of the Ulster lordships before 1600. Gaelic Lords consolidated this development by building castles and friaries at these fixed trading places.