Interferon-free therapy for hepatitis C, how prepared is Australia for biosimilars?

The Hepatitis C virus (HCV) affects some 150 million people worldwide. However, unlike hepatitis A and B there is no vaccination for HCV and approximately 75% of people exposed to HCV develop chronic hepatitis. In Australia, around 226,700 people live with chronic HCV infection costing the government approximately $252 million per year. Historically, the standard approved/licenced treatment for HCV is pegylated interferon with ribavirin. There are major drawbacks with interferon-based therapy including side effects, long duration of therapy, limited access and affordability. Our previous survey of an at-risk population reported HCV treatment coverage of only 5%. Since April 2013, a new class of interferon-free treatments for chronic HCV is subsidised under the Pharmaceutical Benefits Scheme: boceprevir and telaprevir - estimated to cost the Australian Government in excess of $220 million over five years. Other biologic interferon-free therapeutic agents are scheduled to enter the Australian market. Use of small molecule generic pharmaceuticals has been advocated as a means of public cost savings. However, with the new biologic agents, generics (biosimilars) may not be feasible or straightforward, due to long patent life; marketing exclusivity; and regulatory complexity for these newer products.

Pharmacogenetics of migraine : genetic variants and their potential role in migraine therapy

Migraine is a paroxysmal neurological disorder affecting up to 6% of males and 18% of females in the general population, and has been demonstrated to have a strong, but complex, genetic component. Genetic investigation of migraine provides hope that new targets for medications and individual specific therapy will be developed. The identification of polymorphisms or genetic biomarkers for disease susceptibility and treatment should aid in providing a better understanding of migraine pathology and, consequently, more appropriate and efficient treatment for migraineurs. In this review, we will discuss results investigating genetic biomarkers for migraine and their potential role in future therapy planning.

A pharmacogenomic evaluation of migraine therapy

Migraine is a common idiopathic primary headache disorder with significant mental, physical and social health implications. Accompanying an intense unilateral pulsating head pain other characteristic migraine symptoms include nausea, emesis, phonophobia, photophobia and in approximately 20-30% of migraine cases, neurologic disturbances associated with the aura phase. Although selective serotonin (5-HT) receptor agonists (i.e., 5-HT(1B/1D)) are successful in alleviating migrainous symptoms in < or = 70% of known sufferers, for the remaining 30%, additional migraine abortive medications remain unsuccessful, not tested or yet to be identified. Genetic characterization of the migrainous disorder is making steady progress with an increasing number of genomic susceptibility loci now identified on chromosomes 1q, 4q, 5q, 6p, 11q, 14q, 15q, 17p, 18q, 19p and Xq. The 4q, 5q, 17p and 18q loci involve endophenotypic susceptibility regions for various migrainous symptoms. In an effort to develop individualized pharmacotherapeutics, the identification of these migraine endophenotypic loci may well be the catalyst needed to aid in this goal. In this review the authors discuss the present treatment of migraine, known genomic susceptibility regions and results from migraine (genetic) association studies. The authors also discuss pharmacogenomic considerations for more individualized migraine prophylactic treatments.

Electrospraying of polymers with therapeutic molecules : state of the art

The encapsulation and release of bioactive molecules from polymeric vehicles represents the holy grail of drug and growth factor delivery therapies, whereby sustained and controlled release is crucial in eliciting a positive therapeutic effect. To this end, electrospraying is rapidly emerging as a popular technology for the production of polymeric particles containing bioactive molecules. Compared with traditional emulsion fabrication techniques, electrospraying has the potential to reduce denaturation of protein drugs and affords tighter regulation over particle size distribution and morphology. In this article, we review the importance of the electrospraying parameters that enable reproducible tailoring of the particles' physical and in vitro drug release characteristics, along with discussion of existing in vivo data. Controlled morphology and monodispersity of particles can be achieved with electrospraying, with high encapsulation efficiencies and without unfavorable denaturation of bioactive molecules throughout the process. Finally, the combination of electrospraying with electrospun scaffolds, with an emphasis on tissue regeneration is reviewed, depicting a technique in its relative infancy but holding great promise for the future of regenerative medicine.

The paradox of autistic art

Certain autistic children whose linguistic ability is virtually nonexistent can draw natural scenes from memory with astonishing accuracy. In particular their drawings display convincing perspective. In contrast, normal children of the same preschool age group and even untrained adults draw primitive schematics or symbols of objects which they can verbally identify. These are usually conceptual outlines devoid of detail. It is argued that the difference between autistic child artists and normal individuals is that autistic artists make no assumptions about what is to be seen in their environment. They have not formed mental representations of what is significant and consequently perceive all details as equally important. Equivalently, they do not impose visual or linguistic schema -- a process necessary for rapid conceptualisation in a dynamic existence, especially when the information presented to the eye is incomplete.

Medical nutrition therapy and simple interventions can improve intake in patients who eat poorly in hospital

The Australasian Nutrition Care Day Survey (ANCDS) reported two-in-five patients in Australian and New Zealand hospitals consume ≤50% of the offered food. The ANCDS found a significant association between poor food intake and increased in-hospital mortality after controlling for confounders (nutritional status, age, disease type and severity)1. Evidence for the effectiveness of medical nutrition therapy (MNT) in hospital patients eating poorly is lacking. An exploratory study was conducted in respiratory, neurology and orthopaedic wards of an Australian hospital. At baseline, 24-hour food intake (0%, 25%, 50%, 75%, 100% of offered meals) was evaluated for patients hospitalised for ≥2 days and not under dietetic review. Patients consuming ≤50% of offered meals due to nutrition-impact symptoms were referred to ward dietitians for MNT with food intake re-evaluated on day-7. 184 patients were observed over four weeks. Sixty-two patients (34%) consumed ≤50% of the offered meals. Simple interventions (feeding/menu assistance, diet texture modifications) improved intake to ≥75% in 30 patients who did not require further MNT. Of the 32 patients referred for MNT, baseline and day-7 data were available for 20 patients (68±17years, 65% females, BMI: 22±5kg/m2, median energy, protein intake: 2250kJ, 25g respectively). On day-7, 17 participants (85%) demonstrated significantly higher consumption (4300kJ, 53g; p<0.01). Three participants demonstrated no improvement due to ongoing nutrition-impact symptoms. “Percentage food intake” was a quick tool to identify patients in whom simple interventions could enhance intake. MNT was associated with improved dietary intake in hospital patients. Further research is needed to establish a causal relationship.

Development and implementation of the Australian universities radiation therapy student clinical assessment form

Purpose: Prior to 2009, one of the problems faced by radiation therapists who supervised and assessed students on placement in Australian clinical centres, was that each of the six Australian universities where Radiation Therapy (RT) programmes were conducted used different clinical assessment and reporting criteria. This paper describes the development of a unified national clinical assessment and reporting form that was implemented nationally by all six universities in 2009. Methods: A four phase methodology was used to develop the new assessment form and user guide. Phase 1 included university consensus around domains of student practice and assessment, and alignment with national competency standards; Phase 2 was a national consensus workshop attended by radiation therapists involved in student supervision and assessment; Phase 3 was an action research re-iterative Delphi technique involving two rounds of a mail-out to gain further expert consensus; and stage 4 was national piloting of the developed assessment form. Results: The new assessment form includes five main domains of practice and 19 sub-domain criteria which students are assessed against during placement. Feedback from the pilot centre participants was positive, with the new form being assessed to be comprehensive and complemented by the accompanying user guide. Conclusion: The new assessment form has improved both the formative and summative assessment of students on placement, as well as enhancing the quality of feedback to students and the universities. The new national form has high acceptance from the Australian universities and has been subject to wide review by the profession.

Constructing the shitting citizen : the promise of scatological art as environmental and social activism

Art activism uses visual and performance art to promote social and environmental agendas. In this paper, I explore attempts to raise awareness of sanitation issues at the global, local and personal level using scatological art. I focus on the successes of the open-air public art exhibition set up in the Brisbane (Queensland, Australia) central business district to celebrate World Toilet Day in 2008. The art in this exhibition featured included one hundred toilets decorated to raise awareness of global sanitation issues and the distribution of promotional materials featuring scatological images including postcards and stickers. Given the subject matter and intent, the toilet art and promotional materials presented at the One Hundred Toilet exhibition can be seen as an example of scatological art employed for the purposes of social and environmental activism. Through the One Hundred Toilet exhibition, I consider the political aims and activist potential of using scatological art to progress social and environmental agendas and consider how this kind of ‘shit on show’ approach can contribute to the construction of the shitting citizen; one who is simultaneously responsible for and responsive to managing the waste that they produce and recognising and responding to broader sanitation issues.

Addressing the impediments copyright imposes on the use of patent specifications and prior art documents to improve patent quality

This article considers from an Australian perspective the impediments that copyright law places in the path of those who seek to use patent specifications and non-patent prior art documents in ways that are necessary to the proper functioning of the patent system. Until recently, copyright law in Australia had limited the uses to which members of the public could put patent specifications in that country. Those impediments have been removed as a result of an important legislative change to the way in which copyright in patent specifications can be enforced. The change gives the public a greater freedom to make use of patent specifications than it enjoyed before, and removes unwarranted restrictions upon the ways in which the public can reuse valuable information. However, what the amendment does not address is the impediments copyright imposes on using non-patent prior art documents in ways that advance the public interest.

Copyright in patent specifications and prior art documents: Addressing legitimate rights of user

One of the recent Raising the Bar amendments has removed impediments imposed by copyright law that may have limited the uses to which IP Australia and members of the public could have lawfully put patent specifications without seeking permission from the copyright owner. What the amendment does not do, however, is extend the same protections to those who wish to use prior art documents in ways that benefit the patent system and further the public interest.

The Art of Freestyle

"This book is intended to be instructional, inspirational and of interest to both novice and expert alike. The assumption is made that to even begin to playboat the paddler will already be an intermdiate white water boater familiar with basic strokes and boating skills. For the interested non paddler a glossary of terms is included. Part One gives an overview of the sport and lays the foundations of understanding on which the rest of the book builds, as well as exploring safety issues and exploring key concepts. Part Two describes and coaches the moves which are divided into intermediate and advanced standard. Part Three looks at how to train in order to hone your physical and mental skills and be 'the best you can be'. Never before has so much freestyle, rodeo and playboating information from so many great boaters been gathered together in one place. In a world dominated by the biggest, the fastest, the loudest...the most big headed, this book makes a stand. Whilst of course covering all the latest moves, the authors have not been frightened to start right back at basic concepts. Technical ability is nothing without knowledge, without planning and without stamina. This book tells you the secrets. Freestyle is a thinking person's sport. The authors, the contributors and the book's publisher have an unrivalled breadth of knowledge in this field, so let this book do some of the thinking for you. The full colour format and the emphasis on personal training and coaching make for a particularly easy read. When planning my preparation or training before a competition, I always try to evaluate its potential benefits in terms of how many places it will have helped me move up in the final results. As a general rule in life, any time spent off the water should be viewed with suspicion! However, use this time constructively and absorb the information in this book and you will reap your own rewards. The Art of Freestyle is a book genuinely written by paddlers for paddlers. It is often a hard task to get top athletes to part with their preferred training or competition techniques, but this book is full of such 'Top Tips'. This is not a book written just by its authors, but by a wealth of accomplished paddlers. It is this subtle combination that keeps the reader in the real world...believing in a move, not just imagining it. This is the real world...believe you can do it."--Playak Website

Looking into the light : reinventing the apparatus in contemporary art

Technical images such as photography, film and video, are dependent on apparatuses for their production and dissemination, yet the apparatus itself is often hidden or obscured in the experience of the work and the discourse that surrounds it. This practice-led research identifies key practice strategies to foreground the apparatus both in the production of work and in its presentation. It therefore develops critical and generative strategies to explore and interrogate the workings of the 'apparatus-audience complex,' and the particular modes of spectatorship that this entails.

An exploratory study to evaluate whether medical nutrition therapy can improve dietary intake in hospital patients who eat poorly

Background and aims The Australasian Nutrition Care Day Survey (ANCDS) reported two-in-five patients consume ≤50% of the offered food in Australian and New Zealand hospitals. After controlling for confounders (nutritional status, age, disease type and severity), the ANCDS also established an independent association between poor food intake and increased in-hospital mortality. This study aimed to evaluate if medical nutrition therapy (MNT) could improve dietary intake in hospital patients eating poorly. Methods An exploratory pilot study was conducted in the respiratory, neurology and orthopaedic wards of an Australian hospital. At baseline, percentage food intake (0%, 25%, 50%, 75%, and 100%) was evaluated for each main meal and snack for a 24-hour period in patients hospitalised for ≥2 days and not under dietetic review. Patients consuming ≤50% of offered meals due to nutrition-impact symptoms were referred to ward dietitians for MNT. Food intake was re-evaluated on the seventh day following recruitment (post-MNT). Results 184 patients were observed over four weeks; 32 patients were referred for MNT. Although baseline and post-MNT data for 20 participants (68±17years, 65% females) indicated a significant increase in median energy and protein intake post-MNT (3600kJ/day, 40g/day) versus baseline (2250kJ/day, 25g/day) (p<0.05), the increased intake met only 50% of dietary requirements. Persistent nutrition impact symptoms affected intake. Conclusion In this pilot study whilst dietary intake improved, it remained inadequate to meet participants’ estimated requirements due to ongoing nutrition-impact symptoms. Appropriate medical management and early enteral feeding could be a possible solution for such patients.

The art of being a fan : complicity and criticality in contemporary art and fandom

This practice-led research project aims to use contemporary art processes and concepts of fandom to construct a space for the critical and creative exploration of the relationship between them. Much of the discourse addressing the intersection of these spaces over the last three decades tends to treat art and fan studies as separate areas of critical and theoretical research. There has also been very little consideration of the critical interface that art practice and fandom share in their engagement with one another – or how the artist as fan might creatively exploit this relationship. Approaching these issues through a practice-led methodology that combines studio based explorations and traditional modes of research, the project aims to demonstrate how my 'fannish' engagements with popular culture can generate new responses to, and understandings of, the relationship between fandom, affect and visual art. The research acts as a performative and creative investigation of fandom as I document the complicit tendencies that arise out of my affective relationship with pop cultural artefacts. It does this through appropriating and reconfiguring content from film, television and print media, to create digital video installations aimed at engendering new experiences and critical interpretations of screen culture. This approach promotes new possibilities for creative engagements with art and popular culture, and these are framed through the lens of what I term the digital-bricoleur. The research will be primarily contextualised by examining other artists' practices as well as selected theoretical frameworks that traverse my investigative terrain. The key artists that are discussed include Douglas Gordon, Candice Brietz, Pierre Huyghe, Paul Pfieffer, and Jennifer and Kevin McCoy. The theoretical developments of the project are drawn from a pluralistic range of ideas ranging from Johanna Drucker's discussion of critical complicity in contemporary art, Matt Hills' discussion of subjectivity in fandom and academia, Nicolas Bourriaud's discussion of Postproduction art practices, and Jacques Rancière's ideas about aesthetics and politics. The methodology and artworks developed over the course of this project will also demonstrate how digital-bricolage leads to new understandings of the relationships between contemporary art and entertainment. The research aims to exploit these apparently contradictory positions to generate a productive site for rethinking the relationship between the creative and critical possibilities of art and fandom. The outcomes of the research consists of a body of artworks – 75% – that demonstrate new contributions to knowledge, and an exegetical component – 25% – that acts to reflect on, analyse and critically contextualise the practice-led findings.