Is Australia ready for biosimilars?

The biosimilars market is potentially the single fastest growing pharmaceutical sector with an estimated worth of US$67bn in global sales by 2020. This market generally refers to larger molecule, biological, protein-based pharmaceuticals which have lost its patent. This has stimulated the emergence of non-conventional pharmaceutical investors such as Fujifilm and Samsung as well as host countries such as Brazil, Mexico, China, India, South Korea, Turkey and Russia, which view biosimilars as a key macroeconomic driver of growth. Internationally, the European Medicines Agency has led the regulation of the quality, safety and efficacy of biosimilars; however, many countries have developed their own biosimilar regulatory frameworks. Despite the similarity of these with European guidelines, differences do exist across jurisdictions and have implications for cross-jurisdictional registration and regulation. The consideration of biosimilar regulation, however, demands attention beyond quality, safety and efficacy. The potential implications of extended patent protection, international trade and globalisation require a congruent policy approach to their regulation. Notwithstanding the fact that Australia is a relatively small pharmaceutical market and that there are only 14 biosimilar products currently approved for use, Australia’s geographical proximity to pharm-emerging countries and its trade relation with the major pharmaceutical markets have positioned Australia in a unique position to influence international development and regulation of biosimilars. Australia’s National Medicines Policy (2000) potentially provides the foundation for a partnership approach to biosimilar regulation, minimise duplication of regulatory efforts while at the same time fostering a viable pharmaceutical industry.

A multi-level ecological model of psychotropic prescribing to adults with intellectual disability

Purpose – Simple linear accounts of prescribing do not adequately address reasons “why” doctors prescribe psychotropic medication to people with intellectual disability (ID). Greater understanding of the complex array of factors that influence decisions to prescribe is needed. Design/methodology/approach – After consideration of a number of conceptual frameworks that have potential to better understand prescribing of psychotropic medication to adults with ID, an ecological model of prescribing was developed. A case study is used to outline how the model can provide greater understanding of prescribing processes. Findings – The model presented aims to consider the complexity and multi-dimensional nature of community-based psychotropic prescribing to adults with ID. The utility of the model is illustrated through a consideration of the case study. Research limitations/implications – The model presented is conceptual and is as yet untested. Practical implications – The model presented aims to capture the complexity and multi-dimensional nature of community-based psychotropic prescribing to adults with ID. The model may provide utility for clinicians and researchers as they seek clarification of prescribing decisions. Originality/value – The paper adds valuable insight into factors influencing psychotropic prescribing to adults with ID. The ecological model of prescribing extends traditional analysis that focuses on patient characteristics and introduces multi-level perspectives that may provide utility for clinicians and researchers.

Plasmodium falciparum parasites lacking histidine-rich protein 2 and 3 : a review and recommendations for accurate reporting

Malaria rapid diagnostic tests (RDTs) play a critical role in malaria case management, surveillance and case investigations. Test performance is largely determined by design and quality characteristics, such as detection sensitivity, specificity, and thermal stability. However, parasite characteristics such as variable or absent expression of antigens targeted by RDTs can also affect RDT performance. Plasmodium falciparum parasites lacking the PfHRP2 protein, the most common target antigen for detection of P. falciparum, have been reported in some regions. Therefore, accurately mapping the presence and prevalence of P. falciparum parasites lacking pfhrp2 would be an important step so that RDTs targeting alternative antigens, or microscopy, can be preferentially selected for use in such regions. Herein the available evidence and molecular basis for identifying malaria parasites lacking PfHRP2 is reviewed, and a set of recommended procedures to apply for future investigations for parasites lacking PfHRP2, is proposed.

An orientation to early childhood education for sustainability and research : framing the text

This publication arose from the interests of the chapter authors, ‘a small group of thoughtful people’ almost all of whom participated in one or both Transnational Dialogues in Research in Early Childhood Education for Sustainability, held in Stavanger, Norway in 2010 and Brisbane, Australia in 2011 (Refer Appendix 1 for list of participants). These meetings were the first time that a critical mass of researchers from vastly different parts of the globe - Norway, Sweden, Australia and New Zealand at the inaugural meeting, with additional participants from Korea, Japan and Singapore attending the second - had come together to debate, discuss and share ideas about research and theory in the emerging field of Early Childhood Education for Sustainability (ECEfS. Some of the researchers who joined these Transnational Dialogues, had met serendipitously at earlier conferences and meetings, or corresponded via email, but many had never met face-to-face. Now a significant number are contributing authors in this text. It is a testament to these researchers’ interest in this agenda that they mostly self-funded their travel and other costs to attend the Transnational Dialogues research meetings. While most chapter authors come from the field of early childhood education, a few are more aligned with education for sustainability/environmental education, while a much smaller number are already working at the intersection of early childhood education and education for sustainability. What we share as a group is a range of perspectives and orientations to research and to the research focus at the heart of this book - young children and their actual and potential capabilities as agents of change for sustainability. As researchers, regardless of experience and perspectives, participants knew they had something extra to offer - their expertise as researchers - providing scholarly insights into the work of practitioners, applying critically reflective lenses to curricula, pedagogies and assumptions, testing of ideas and theories, and presenting a sense for where ECEfS might fit or, indeed, go beyond norms and orthodoxies. This is a text, then, for both researchers and those whose primary interests lie in daily interactions with children, families and communities.

Examining early childhood education through the lens of education for sustainability : revisioning rights

This chapter calls for rethinking about the rights base of early childhood education. The United Nations Convention on the Rights of the Child (UNCRC) (UNICEF1989) has been seen as an important foundation internationally for early childhood education practise. In this paper, I argue that whilst the UNCRC (1989) still serves its aspirational purpose, it is an inadequate vehicle for enacting early childhood education in the twenty-first century given the pressing challenges of sustainability. The UNCRC emerged from an individual rights perspective, and despite attempts to broaden the rights agenda towards greater child participation and engagement, these approaches offer an inadequate response to global sustainability concerns. In this chapter, I propose a five dimensional approach to rights that acknowledges the fundamental rights of children as espoused in the UNCRC and the call for agentic rights as advocated more recently by early childhood academics and practitioners. Additionally, however, discussion of collective rights, intergenerational rights and bio/ecocentic rights are forwarded, offering a expanded way to think about rights with implications for how early childhood education is practised and researched.

Investigating early childhood education for sustainability : insights from history and literature

Seemingly straightforward tasks often have a way of becoming complex. This was the case for our guest editorial team charged with creating Early Childhood Australia’s Best of Sustainability publication drawn from the the Australasian Journal of Early Childhood and Every Child. The complexities we encountered ranged from the varied terminologies and understandings of constructs such as education for sustainable development, environmental education and education for sustainability, through to the fundamental lack of published research on which to draw as the basis for a special issue. It is timely to explore these complexities as we face the global challenges of The Critical Decade (DCCEE, 2011) including rising sea levels, extreme weather events and food security. At a local level, the early childhood field in Australia is seeking to interpret sustainability with systemic support from the National Quality Standards(NQS) (ACECQA, 2011), while elsewhere environmental/sustainability education is encouraged through national curricula documents (for example, Singapore Ministry of Education, 2008; Swedish National Agency for Education,2010; Ministry of Education of Korea, 2011). Both The Critical Decade and the NQS provide imperatives to drive early childhood education’s engagement with sustainability. In other words, sustainability in early childhood education is no longer optional, but essential (Elliott, 2010). While some twenty years of advocacy has led to this somewhat subdued celebratory position, in this publication we do recognise the historical contexts that have led to early childhood education for sustainability (ECEfS), as we (Elliott & Davis) phrase it, becoming almost ‘mainstream not marginal’ (Davis, 1999)— a stitching together of the isolated ‘patches of green’, first identified a decade ago by Elliott (NSW EPA, 2003). Here we weave together, through these articles, a story of the evolving history of ECEfS from our particular perspective. In so doing, we also acknowledge that there are other perspectives or ‘paths’ for this field as identified by Edwards and Cutter-McKenzie in their concluding paper to this compilation.

Global sequence variation in the histidine-rich proteins 2 and 3 of Plasmodium falciparum: implications for the performance of malaria rapid diagnostic tests

Background Accurate diagnosis is essential for prompt and appropriate treatment of malaria. While rapid diagnostic tests (RDTs) offer great potential to improve malaria diagnosis, the sensitivity of RDTs has been reported to be highly variable. One possible factor contributing to variable test performance is the diversity of parasite antigens. This is of particular concern for Plasmodium falciparum histidine-rich protein 2 (PfHRP2)-detecting RDTs since PfHRP2 has been reported to be highly variable in isolates of the Asia-Pacific region. Methods The pfhrp2 exon 2 fragment from 458 isolates of P. falciparum collected from 38 countries was amplified and sequenced. For a subset of 80 isolates, the exon 2 fragment of histidine-rich protein 3 (pfhrp3) was also amplified and sequenced. DNA sequence and statistical analysis of the variation observed in these genes was conducted. The potential impact of the pfhrp2 variation on RDT detection rates was examined by analysing the relationship between sequence characteristics of this gene and the results of the WHO product testing of malaria RDTs: Round 1 (2008), for 34 PfHRP2-detecting RDTs. Results Sequence analysis revealed extensive variations in the number and arrangement of various repeats encoded by the genes in parasite populations world-wide. However, no statistically robust correlation between gene structure and RDT detection rate for P. falciparum parasites at 200 parasites per microlitre was identified. Conclusions The results suggest that despite extreme sequence variation, diversity of PfHRP2 does not appear to be a major cause of RDT sensitivity variation.

E-mail in the workplace : the role of stress appraisals and normative response pressure in the relationship between email stressors and employee strain

In many organizations, e-mail is an effective and dominant workplace application tool; however, research identifying its role as a potential workplace stressor remains limited. Utilizing the Transactional Model of Stress (Lazarus & Folkman, 1984), 215 full-time administrative and academic staff at a university were surveyed about workplace e-mail. The aim was to study the effects of potential e-mail stressors on emotional exhaustion as mediated and moderated by person and situation variables. Results indicated that 2 distinct e-mail stressors—high quantity and poor quality (in terms of high emotionality and ambiguity) of workplace e-mail—were associated both with stress appraisals (e-mail overload and e-mail uncertainty) and with emotional exhaustion. Furthermore, the effects of the 2 e-mail stressors on emotional exhaustion were mediated by appraised e-mail overload. Perceived normative response pressure—a relevant aspect of the specific work environment—added to the explanation of emotional exhaustion and accentuated the positive effect of e-mail ambiguity on emotional exhaustion, although effects involving normative response pressure were not explained by the stress appraisals.

Adenovirus species C is associated with chronic suppurative lung diseases in children

Background The role of human adenoviruses (HAdVs) in chronic respiratory disease pathogenesis is recognized. However, no studies have performed molecular sequencing of HAdVs from the lower airways of children with chronic endobronchial suppuration. We thus examined the major HAdV genotypes/species, and relationships to bacterial coinfection, in children with protracted bacterial bronchitis (PBB) and mild bronchiectasis (BE). Methods Bronchoalveolar lavage (BAL) samples of 245 children with PBB or mild (cylindrical) BE were included in this prospective cohort study. HAdVs were genotyped (when possible) in those whose BAL had HAdV detected (HAdV+). Presence of bacterial infection (defined as ≥104 colony-forming units/mL) was compared between BAL HAdV+ and HAdV negative (HAdV−) groups. Immune function tests were performed including blood lymphocyte subsets in a random subgroup. Results Species C HAdVs were identified in 23 of 24 (96%) HAdV+ children; 13 (57%) were HAdV-1 and 10 (43%) were HAdV-2. An HAdV+ BAL was significantly associated with bacterial coinfection with Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae (odds ratio [OR], 3.27; 95% confidence interval, 1.38–7.75; P = .007) and negatively associated with Staphylococcus aureus infection (P = .03). Young age was related to increased rates of HAdV+. Blood CD16 and CD56 natural killer cells were significantly more likely to be elevated in those with HAdV (80%) compared with those without (56.1%) (P = .027). Conclusions HAdV-C is the major HAdV species detected in the lower airways of children with PBB and BE. Younger age appears to be an important risk factor for HAdV+ of the lower airways and influences the likelihood of bacterial coinfection

Understanding Heliothine (Lepidoptera: Heliothinae) pests: What is a host plant?

Heliothine moths (Lepidoptera: Heliothinae) include some of the world's most devastating pest species. Whereas the majority of nonpest heliothinae specialize on a single plant family, genus, or species, pest species are highly polyphagous, with populations often escalating in size as they move from one crop species to another. Here, we examine the current literature on heliothine host-selection behavior with the aim of providing a knowledge base for research scientists and pest managers. We review the host relations of pest heliothines, with a particular focus on Helicoverpa armigera (Hubner), the most economically damaging of all heliothine species. We then consider the important question of what constitutes a host plant in these moths, and some of the problems that arise when trying to determine host plant status from empirical studies on host use. The top six host plant families in the two main Australian pest species (H. armigera and Helicoverpa punctigera Wallengren) are the same and the top three (Asteraceae, Fabaceae, and Malvaceae) are ranked the same (in terms of the number of host species on which eggs or larvae have been identified), suggesting that these species may use similar cues to identify their hosts. In contrast, for the two key pest heliothines in the Americas, the Fabaceae contains approximate to 1/3 of hosts for both. For Helicoverpa zea (Boddie), the remaining hosts are more evenly distributed, with Solanaceae next, followed by Poaceae, Asteraceae, Malvaceae, and Rosaceae. For Heliothis virescens (F.), the next highest five families are Malvaceae, Asteraceae, Solanaceae, Convolvulaceae, and Scrophulariaceae. Again there is considerable overlap in host use at generic and even species level. H. armigera is the most widely distributed and recorded from 68 plant families worldwide, but only 14 families are recorded as a containing a host in all geographic areas. A few crop hosts are used throughout the range as expected, but in some cases there are anomalies, perhaps because host plant relation studies are not comparable. Studies on the attraction of heliothines to plant odors are examined in the context of our current understanding of insect olfaction, with the aim of better understanding the connection between odor perception and host choice. Finally, we discuss research into sustainable management of pest heliothines using knowledge of heliothine behavior and ecology. A coordinated international research effort is needed to advance our knowledge on host relations in widely distributed polyphagous species instead of the localized, piecemeal approaches to understanding these insects that has been the norm to date.

Malaria rapid diagnostic test performance : results of WHO product testing of malaria RDTs : round 5 (2013)

WHO estimates that half the world’s population is at risk of malaria. In 2012, there were an estimated 207 million cases (with an uncertainty range of 135 million to 287 million) and an estimated 627 000 deaths (with an uncertainty range of 473 000 to 789 000). Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and 77% occur in children under 5 years. Malaria remains endemic in 104 countries, and, while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly confirmed, resulting in over-use of antimalarial drugs and poor disease monitoring (1)...

Integrated chronic disease management in primary-secondary care : a systematic literature review of the evidence

Introduction: Diabetes has traditionally been managed as a single chronic disease state, but it exists with co-morbidities such as depression and metabolic syndrome. Treatment is multifaceted, requiring both primary and secondary care, however, the delivery of diabetes care is often fragmented. Integrated chronic disease management is a growing model of interest, and is underpinned by the chronic care model (CCM), devised as a guide for primary care management of patients with chronic conditions. The model identifies six key elements for effective care, and has shown promise in improving the management of diabetes. Aim: To find empirical evidence of integrated care interventions targeted at co-morbidities including diabetes, across primary/secondary care. Method: A systematic review of peer reviewed literature from PubMed, CINAHL, Embase, Cochrane Library and Joanna Briggs was performed. Studies were reviewed according to inclusion criteria- studies published in English, between 2004-2014, empirical studies, studies with evidence of primary/secondary implementation, and those dealing with chronic co-morbid disease states. Results: 51 studies met the inclusion criteria. Included studies were mostly from the US (38), with five from Australia, UK (2), Canada (2), Netherlands (1), Norway (1), Ireland (1), and one multi-country study. It was found that all interventions adopted at least one (average 3-4) of the chronic care model, with the majority implementing delivery system redesign activities within the primary care practice/s. We found evidence of interventions which significantly reduced emergency department and hospital admissions, improved processes of care, patient health outcomes such as HbA1c, improved patient satisfaction, and reduced costs. Conclusion/Implications for practice: Diabetes exists as a co-morbid disease, requiring both primary and secondary care. We found that integrated care interventions adopting elements of the chronic care model positively impacted on patient outcomes, service utilisation, as well as costs. This review has highlighted that it may not be necessary to adopt all CCM elements to improve clinical outcomes, patient satisfaction and costs.

Cultivation

The interest in potentially economically valuable plants (for food, timber, dyes, fabric, and drugs) was part of the concerted effort given by colonial governments towards providing botanic gardens in new colonies. While convicts and guards laboured in Brisbane Town from 1825 until 1849, botanists such as Alan Cunningham were discovering the delights of native plants in their numerous excursions. Their observations and collections of seeds were sent south (to the local botanic gardens at Melbourne and Sydney) and onward to the Royal Botanic Gardens in Britain (at Kew and Edinburgh). This set the local pattern for future exchanges among the global British Imperial botanic garden network...

Australian screen content in education

Our presentation today will introduce our current ARC Linkage project on Australian screen content in education. We will then go on to discuss our initial research, which is attempting to quantify the use of screen content in Australian education. The presentation concludes with a brief discussion of some of the emerging video on demand services available to schools and universities.

Kirsten ras mutations in patients with colorectal cancer : the ‘RASCAL II’ study

Researchers worldwide with information about the Kirsten ras (Ki-ras) tumour genotype and outcome of patients with colorectal cancer were invited to provide that data in a schematized format for inclusion in a collaborative database called RASCAL (The Kirsten ras in-colorectal-cancer collaborative group). Our results from 2721 such patients have been presented previously and for the first time in any common cancer, showed conclusively that different gene mutations have different impacts on outcome, even when the mutations occur at the same site on the genome. To explore the effect of Ki-ras mutations at different stages of colorectal cancer, more patients were recruited to the database, which was reanalysed when information on 4268 patients from 42 centres in 21 countries had been entered. After predetermined exclusion criteria were applied, data on 3439 patients were entered into a multivariate analysis. This found that of the 12 possible mutations on codons 12 and 13 of Kirsten ras, only one mutation on codon 12, glycine to valine, found in 8.6% of all patients, had a statistically significant impact on failure-free survival (P = 0.004, HR 1.3) and overall survival (P = 0.008, HR 1.29). This mutation appeared to have a greater impact on outcome in Dukes’ C cancers (failure-free survival, P = 0.008, HR 1.5; overall survival P = 0.02, HR 1.45) than in Dukes’ B tumours (failure-free survival, P = 0.46, HR 1.12; overall survival P = 0.36, HR 1.15). Ki-ras mutations may occur early in the development of pre-cancerous adenomas in the colon and rectum. However, this collaborative study suggests that not only is the presence of a codon 12 glycine to valine mutation important for cancer progression but also that it may predispose to more aggressive biological behaviour in patients with advanced colorectal cancer.