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.

Production of a broad specificity antibody for the development and validation of an optical SPR screening method for free and intracellular microcystins and nodularin in cyanobacteria cultures

A highly sensitive broad specificity monoclonal antibody was produced and characterised for microcystin detection through the development of a rapid surface plasmon resonance (SPR) optical biosensor based immunoassay. The antibody displayed the following cross-reactivity: MC-LR 100%; MC-RR 108%; MC-YR 68%; MC-LA 69%; MC-LW 71%; MC-LF 68%; and Nodularin 94%. Microcystin-LR was covalently attached to a CM5 chip and with the monoclonal antibody was employed in a competitive 4min injection assay to detect total microcystins in water samples below the WHO recommended limit (1µg/L). A 'total microcystin' level was determined by measuring free and intracellular concentrations in cyanobacterial culture samples as this toxin is an endotoxin. Glass bead beating was used to lyse the cells as a rapid extraction procedure. This method was validated according to European Commission Decision 96/23/EC criteria. The method was proven to measure intracellular microcystin levels, the main source of the toxin, which often goes undetected by other analytical procedures and is advantageous in that it can be used for the monitoring of blooms to provide an early warning of toxicity. It was shown to be repeatable and reproducible, with recoveries from spiked samples ranging from 74 to 123%, and had % CVs below 10% for intra-assay analysis and 15% for inter-assay analysis. The detection capability of the assay was calculated as 0.5ng/mL for extracellular toxins and 0.05ng/mL for intracellular microcystins. A comparison of the SPR method with LC-MS/MS was achieved by testing six Microcystis aeruginosa cultures and this study yielded a correlation R(2) value of 0.9989.

Taguchi optimisation approach for production of activated carbon from phosphoric acid impregnated palm kernel shell by microwave heating

Taguchi method was applied to investigate the optimal operating conditions in the preparation of activated carbon using palm kernel shell with quadruple control factors: irradiation time, microwave power, concentration of phosphoric acid as impregnation substance and impregnation ratio between acid and palm kernel shell. The best combination of the control factors as obtained by applying Taguchi method was microwave power of 800 W, irradiation time of 17 min, impregnation ratio of 2, and acid concentration of 85%. The noise factor (particle size of raw material) was considered in a separate outer array, which had no effect on the quality of the activated carbon as confirmed by t-test. Activated carbon prepared at optimum combination of control factors had high BET surface area of 1,473.55 m² g-1 and high porosity. The adsorption equilibrium and kinetic data can satisfactorily be described by the Langmuir isotherm and a pseudo-second-order kinetic model, respectively. The maximum adsorbing capacity suggested by the Langmuir model was 1000 mg g-1.

Production of porous aluminium and iron sulphated oxyhydroxides using industrial grade coagulants for optimised arsenic removal from groundwater

The optimisation of Fe and Al oxyhydroxide materials produced using industrial grade coagulants is presented in this work. The effects of synthesis pH and post-synthesis washing procedure onto the arsenic adsorption capacity of the materials were investigated. It was shown that the materials produced at higher pH were more efficient in removing As(V), especially after cleaning procedure. The materials produced at lower pH were less efficient in removing As(V) but the higher presence of sulphate groups in the materials produced at lower pH enhanced As(III) adsorption. Most performing materials can remove up to 84.7 mg As(V) g^-1 or 77.9 mg As(III) g^-1.

Complexity of concern: Social acceptance of wind energy and the inevitability of dissensus

This presentation will explore the  role that social acceptance of onshore wind can play in understanding and progressing the low carbon transition in Europe. Although this is commonly perceived as arising simply from the overall level of renewable energy generated (and ‘dirty’ energy displaced), its significance goes well beyond this as it helps us understand some of the key issues facing the electricity sector as a social-technical system.  As such it is not only a matter of delivering the necessary infrastructure, but requires the long term mediation of complex multi-governmental arrangements involving a very wide range of actors. The interests of these actors engage hugely different timescales, geographic scales of concern and rationalities that make the arena of social acceptance a cauldron of complexity, mediating between overlapping and incompatible concerns. The presentation will briefly review the nature of some of these relationships and discuss what this means for how we conceive and act on the social acceptance of wind, and what this means for the long term low carbon transition

Rapid and efficient production of L-lactate from xylose using electrodialysis culture-associated product separation

L-Lactate was produced from xylose using electrodialysis culture (ED-C)-associated product separation. In a medium containing 50 g xylose/l, the ED-C was completed in only 32 h (i.e. less than half the time taken by the control culture, without electrodialysis). At 80 g xylose/l, the control culture was unable to consume more than 50 g xylose/1, whereas the ED-C showed increased xylose consumption and was completed by 45 h. The maximum rate of lactate production in the ED-C was higher than that in the control culture. ED-C was also carried out (at 80 g initial xylose/ l) with a supply of fresh xylose-free medium. This ED-C was completed within 30 h, which represents a reduction in fermentation time of 15 h when compared to ED-C without addition of xylose-free medium. Thus, rapid production of L-lactate was achieved by using ED-C which supplied fresh xylose-free medium.

Chase over the Nile: The Social Evolution of Riverine Landscape in Urban Egypt

Throughout its history, Cairo evolved as a regional metropolis that sprawls along the banks of the Nile accumulating narratives of evolving social landscape. Overlooking the Nile reflected a privileged social position and place for the urban elite. In spatial terms, the urban bourgeoisie tend to develop living havens in enclaves that are distant from the populace’s everyday life. Ironically, exclusive settlements only attract urban growth further in their direction. This chapter offers an analytical reading of the socio-spatial structure of Cairo following the emergence and decline of a series bourgeoisie quarters along the shores of the Nile. It reports urban narratives based on archival records, documents and investigation of historical texts and travelers’ accounts. This essay argues that cities are essentially social constructs in which hierarchy and connectivity are fundamental aspects of its economic and spatial logic. Through social ambition and desire for upgrade, middle class infiltrate into bourgeoisie havens and sometimes encircle it, seeking better living condition inscribed by social mobility and connectivity to centres of wealth and power. Being both natural barrier and cohesive spine, the Nile helped Cairo to develop successive nucleuses of highly crafted urban experiences that have left their imprints on the contemporary urban scene.

Social Services of General Interest: The EU Competence Regime and a Constitution of Social Governance

In discussing the potential role of the EU, the Member States, their composite parts and civil society organisations in establishing social services of general interest at sub-national, national, transnational and EU wide levels, this chapter explores the EU competence regime for social services of general interest. Its analysis contradicts a tendency in academic writing to demand protection of national prerogatives for shaping welfare states against EU intervention at all costs, because this would be counterproductive for the progress of the EU project. It submits that an EU constitution of social governance should create mixed responsibilities so that the EU, states and civil society actors support each other in creating preconditions for social integration in the EU. It uses the field of social services of general interests as an example of applying this general theoretical concept.