Turing and the Trans-Pacific Partnership: Intellectual Property, Public Health, and Access to Essential Medicines

A recent controversy in the United States over drug pricing by Turing Pharmaceuticals AG has raised larger issues in respect of intellectual property, access to medicines, and the Trans-Pacific Partnership (TPP). In August 2015, Turing Pharmaceuticals AG – a private biopharmaceutical company with offices in New York, the United States, and Zug, Switzerland - acquired the exclusive marketing rights to Daraprim in the United States from Impax Laboratories Incorporated. Martin Shkreli, Turing’s Founder and Chief Executive Officer, maintained: “The acquisition of Daraprim and our toxoplasmosis research program are significant steps along Turing’s path of bringing novel medications to patients with serious disorders, some of whom often go undiagnosed and untreated.” He emphasised: “We intend to invest in the development of new drug candidates that we hope will yield an even better clinical profile, and also plan to launch an educational effort to help raise awareness and improve diagnosis for patients with toxoplasmosis.” In September 2015, there was much public controversy over the decision of Martin Shkreli to raise the price of a 62 year old drug, Daraprim, from $US13.50 to $US750 a pill. The drug is particularly useful in respect to the treatment and prevention of malaria, and in the treatment of infections in individuals with HIV/AIDS. Daraprim is listed on the World Health Organization’s (WHO) List of Essential Medicines. In the face of much criticism, Martin Shkreli has said that he will reduce the price of Daraprim. He observed: “We've agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit.” He maintained: “We think these changes will be welcomed.” However, he has been vague and ambiguous about the nature of the commitment. Notably, the lobby group, Pharmaceutical Research and Manufacturers of America (PhARMA), disassociated itself from the claims of Turing Pharmaceuticals. The group said: “PhRMA members have a long history of drug discovery and innovation that has led to increased longevity and improved lives for millions of patients.” The group noted: “Turing Pharmaceutical is not a member of PhRMA and we do not embrace either their recent actions or the conduct of their CEO.” The biotechnology peak body Biotechnology Industry Organization also sought to distance itself from Turing Pharmaceuticals. A hot topic: United States political debate about access to affordable medicines This controversy over Daraprim is unusual – given the age of drug concerned. Daraprim is not subject to patent protection. Nonetheless, there remains a monopoly in respect of the marketplace. Drug pricing is not an isolated problem. There have been many concerns about drug pricing – particularly in respect of essential medicines for HIV/AIDS, tuberculosis, and malaria. This recent controversy is part of a larger debate about access to affordable medicines. The dispute raises larger issues about healthcare, consumer rights, competition policy, and trade. The Daraprim controversy has provided impetus for law reform in the US. US Presidential Candidate Hillary Clinton commented: “Price gouging like this in this specialty drug market is outrageous.” In response to her comments, the Nasdaq Biotechnology Index fell sharply. Hillary Clinton has announced a prescription drug reform plan to protect consumers and promote innovation – while putting an end to profiteering. On her campaign site, she has emphasised that “affordable healthcare is a basic human right.” Her rival progressive candidate, Bernie Sanders, was also concerned about the price hike. He wrote a letter to Martin Shkreli, complaining about the price increase for the drug Daraprim. Sanders said: “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications.” He has pushed for reforms to intellectual property to make medicines affordable. The TPP and intellectual property The Daraprim controversy and political debate raises further issues about the design of the TPP. The dispute highlights the dangers of extending the rights of pharmaceutical drug companies under intellectual property, investor-state dispute settlement, and drug administration. Recently, the civil society group Knowledge Ecology International published a leaked draft of the Intellectual Property Chapter of the TPP. Knowledge Ecology International Director, James Love, was concerned the text revealed that the US “continues to be the most aggressive supporter of expanded intellectual property rights for drug companies.” He was concerned that “the proposals contained in the TPP will harm consumers and in some cases block innovation.” James Love feared: “In countless ways, the Obama Administration has sought to expand and extend drug monopolies and raise drug prices.” He maintained: “The astonishing collection of proposals pandering to big drug companies make more difficult the task of ensuring access to drugs for the treatment of cancer and other diseases and conditions.” Love called for a different approach to intellectual property and trade: “Rather than focusing on more intellectual property rights for drug companies, and a death-inducing spiral of higher prices and access barriers, the trade agreement could seek new norms to expand the funding of medical research and development (R&D) as a public good, an area where the US has an admirable track record, such as the public funding of research at the National Institutes of Health (NIH) and other federal agencies.” In addition, there has been much concern about the Investment Chapter of the TPP. The investor-state dispute settlement regime would enable foreign investors to challenge government policy making, which affected their investments. In the context of healthcare, there is a worry that pharmaceutical drug companies will deploy their investor rights to challenge public health measures – such as, for instance, initiatives to curb drug pricing and profiteering. Such concerns are not merely theoretical. Eli Lilly has brought an investor action against the Canadian Government over the rejection of its drug patents under the investor-state dispute settlement regime of the North American Free Trade Agreement (NAFTA). The Health Annex to the TPP also raises worries that pharmaceutical drug companies will able to object to regulatory procedures in respect of healthcare. It is disappointing that the TPP – in the leaks that we have seen – has only limited recognition of the importance of access to essential medicines. There is a need to ensure that there are proper safeguards to provide access to essential medicines – particularly in respect of HIV/AIDs, malaria, and tuberculosis. Moreover, there must be protection against drug profiteering and price gouging in any trade agreement. There should be strong measures against the abuse of intellectual property rights. The dispute over Turing Pharmaceuticals AG and Daraprim is an important cautionary warning in respect of some of the dangers present in the secret negotiations in respect of the TPP. There is a need to preserve consumer rights, competition policy, and public health in trade negotiations over an agreement covering the Pacific Rim.

Unbounding the interaction design problem: The contribution of HCI in three interventions for well-being

In this paper we consider HCI's role in technology interventions for health and well-being. Three projects carried out by the authors are analysed by appropriating the idea of a value chain to chart a causal history from proximal effects generated in early episodes of design through to distal health and well-being outcomes. Responding to recent arguments that favour bounding HCI's contribution to local patterns of use, we propose an unbounded view of HCI that addresses an extended value chain of influence. We discuss a view of HCI methods as mobilising this value chain perspective in multi-disciplinary collaborations through its emphasis on early prototyping and naturalistic studies of use.

"Hey world, take a look at me!": Appreciating the human body on social network sites

Social network sites (SNSs) such as Facebook have the potential to persuade people to adopt a lifestyle based on exercise and healthy nutrition. We report the findings of a qualitative study of an SNS for bodybuilders, looking at how bodybuilders present themselves online and how they orchestrate the SNS with their offline activities. Discussing the persuasive element of appreciation, we aim to extend previous work on persuasion in web 2.0 technologies.

Human trafficking heroes and villains: Representing the problem in anti-trafficking awareness campaigns

Since the declaration by the United Nations that awareness raising should be a key part of efforts to combat human trafficking, government and non-government organisations have produced numerous public awareness campaigns designed to capture the public’s attention and sympathy. These campaigns represent the ‘problem’ of trafficking in specific ways, creating heroes and villains by placing the blame for trafficking on some, while obscuring the responsibility of others. This paper adopts Carol Bacchi’s ‘What is the problem represented to be?’ framework for examining the politicisation of problem representation in 18 anti-trafficking awareness campaigns. It is argued that these campaigns construct a narrow understanding of the problem through the depiction of ‘ideal offenders’. In particular, a strong focus on the demand for commercial sex as causative of human trafficking serves to obscure the problematic role of consumerism in a wide range of industries, and perpetuates an understanding of trafficking that fails to draw a necessary distinction between the demand for labour, and the demand for ‘exploitable’ labour. This problem representation also obscures the role governments in destination countries may play in causing trafficking through imposing restrictive migration regimes that render migrants vulnerable to traffickers.

The problem of simplification: Think-tanks, recipes, equity and ‘Turning around low-performing schools’

Non-government actors such as think-tanks are playing an important role in Australian policy work. As governments increasingly outsource policy work previously done by education departments and academics to these new policy actors, more think-tanks have emerged that represent a wide range of political views and ideological positions. This paper looks at the emergence of the Grattan Institute as one significant player in Australian education policy with a particular emphasis on Grattan’s report ‘Turning around low-performing schools’. Grattan exemplifies many of the facets of Barber’s ‘deliverology’, as they produce reports designed to be easily digested, simply actioned and provide reassurance that there is an answer, often through focusing on ‘what works’ recipes. ‘Turning around low-performing schools’ is a perfect example of this deliverology. However, a close analysis of the Report suggests that it contains four major problems which seriously impact its usefulness for schools and policymakers: it ignores data that may be more important in explaining the turn-around of schools, the Report is overly reliant on NAPLAN data, there are reasons to be suspicious about the evidence assembled, and finally the Report falls into a classic trap of logic—the post hoc fallacy.

The problem with teamwork: A discursive investigation

- Background Teamwork sits comfortably within the vocabularies of most physical education teachers. It is used to both describe and prescribe student behaviour in a variety of physical and sport-related activities. Yet while supporters of sport and PE have readily employed the term, remarkably few pedagogues have taken the time to consider what teamwork refers to, let alone what it means to teach it. - Focus of study In this paper, we examine practitioners' constructions of teamwork. - Participants and setting Data were generated with seven physical education teachers (four male and three female) at a state-funded secondary school near Brisbane, Australia. The teachers ranged in experience from three months to more than 30 years. - Research design The investigation was a case study of one physical education department at a secondary school. - Data collection Three interviews were conducted with each of the teachers. The first was biographical in nature and covered themes such as education and sporting experiences. During the second interviews, teachers produced examples and statements on the topic of teamwork as it occurs within their lessons. The material from the second set of interviews was explored in the final set where the teachers were invited to elaborate on and explain comments from their previous interviews. - Analysis Data were considered from a discursive-constructionist perspective and attention was given to linguistic and grammatical features of the teachers' commentary as well as the cultural relevance of the utterances. The notion of ‘interpretive repertoires’ – essentially cultural explanations bounded by particular socio-linguistic features – provided the central unit of analysis. - Findings The teachers in the project made use of an array of discursive resources to make sense of teamwork. These constructions often bore little resemblance to one another or to existing theories of teamwork. In some cases, the teachers offered vague descriptions or drew on alternative concepts to make sense of teamwork. - Conclusions Without a certain level of agreement in their everyday usage, teachers' constructions of teamwork fail to be convincing or useful. We maintain that a more substantive conceptualisation of teamwork is needed in the field of sport pedagogy and offer suggestions on how this might be accomplished.

Exploring the role of lean thinking in sustainable business practice

A large and growing body of literature has explored corporate environmental sustainability initiatives and their impacts locally, regionally and internationally. While the initiatives provide examples of environmental stewardship and cleaner production, a large proportion of the organisations considered in this literature have ‘sustainable practice’, ‘environmental stewardship’ or similar goals as add-ons to their core business strategy. Furthermore, there is limited evidence of organizations embracing and internalising sustainability principles throughout their activities, products or services. Many challenges and barriers impede outcomes as whole system design or holistic approach to address environmental issues, with some evidence to suggest that targeted initiatives could be useful in making progress. ‘Lean management’ and other lean thinking strategies are often put forward as part of such targeted approaches. Within this context, the authors have drawn on current literature to undertake a review of lean thinking practices and how these influence sustainable business practice, considering the balance of environmental and economic aspects of triple bottom line in sustainability. The review methodology comprised firstly identifying theoretical constructs to be studied, developing criteria for categorising the literature, evaluating the findings within each category and considering the implications of the findings for areas for future research. The evaluation revealed two main areas of consideration: - a) lean manufacturing tools and environmental performance, and; - b) integrated lean and green models and approaches. However the review highlighted the ad hoc use of lean thinking within corporate sustainability initiatives, and established a knowledge gap in the form of a system for being able to consider different categories of environmental impacts in different industries and choose best lean tools or models for a particular problem in a way to ensure holistic exploration. The findings included a specific typology of lean tools for different environmental impacts, drawing from multiple case studies. Within this research context, this paper presents the findings of the review; namely the emerging consensus on the relationships between lean thinking and sustainable business practice. The paper begins with an overview of the current literature regarding lean thinking and its documented role in sustainable business practice. The paper then includes an analysis of lean and green paradigms in different industries; and describes the typology of lean tools used to reduce specific environmental impacts and, integrated lean and green models and approaches. The paper intends to encourage industrial practitioners to consider the merits and potential risks with using specific lean tools to reduce context-specific environmental impacts. It also aims to highlight the potential for further investigation with regard to comparing different industries and conceptualising a generalizable system for ensuring lean thinking initiatives build towards sustainable business practice.

The transfer problem and the intertemporal terms of trade

In this paper the effects of a transfer on the intertemporal terms of trade are examined in the context of a simple two-country, two-period model. When intertemporal trade occurs because the two economies have different rates of time preference, a transfer improves the terms of trade of the paying country. Alternatively, when trade occurs owing to international differences in the endowments of goods over the two periods, the effect of a transfer depends on (a) the relationship between the interest rate and the rates of time preference of the two countries and (b) the relationship between their elasticities of intertemporal consumption substitution.

Running men: The precarious, paranoid body in screen culture

This paper discusses my video installation Running Men as an example of how an artist’s appropriative engagements with screen images of the perilous body can reflect the technological zeitgeist of the last hundred years but also create a space of meditative and mediated reflection in Slavoj Žižek’s “endlessness” of the present-future. In this artwork, iconic male characters from Hollywood films are recontextualised to create infinitely looping scenes of running; trapping the characters in a kind of Nietchzen eternal recurrence that suspends them between impending violence and uncertain futures. Stemming primarily from my investigation into anxiety as a shared social experience, one perhaps primed by the increasing intensity of visual culture in the 21st century, these digitally reconfigured bodies become avatars or surrogates for myself, and for the viewer. Through selective editing, these emblematic figures are caught in a space of relentless confusion and paranoia – they run with, and from anxiety. They are never caught by any unseen pursuers, but are equally unable to catch up to any unseen goal. These figures map an historical trajectory of violence and masculinity as it has been projected through various iterations of screen culture Simultaneously, as celebrities, they are also fictions of the media sphere, both real and ethereal, they are impossible to grasp but paradoxically are objects of identification and emulation. In this duality, the work also references cinema’s tangled conflation of character and celebrity identity. This discussion will address the two distinct but connected sites and activities of body/image engagement. Firstly, the artistic process and conceptual ramifications of this activity, and secondly in the artwork’s potential as an installation to provide an opportunity for the viewer (like the artist) to reflect on the constructed-ness and complicated power structures at play in the representation of a gendered body.

Analysis of body composition in individuals with high bone mass reveals a marked increase in fat mass in women but not men

Context: High bone mass (HBM), detected in 0.2% of dual-energy x-ray absorptiometry (DXA) scans, is characterized by raised body mass index, the basis for which is unclear. Objective: To investigate why body mass index is elevated in individuals with HBM, we characterized body composition and examined whether differences could be explained by bone phenotypes, eg, bone mass and/or bone turnover. Design, Setting, and Participants: We conducted a case-control study of 153 cases with unexplained HBM recruited from 4 UK centers by screening 219 088 DXA scans. Atotal of 138 first-degree relatives (of whom 51 had HBM) and 39 spouses were also recruited. Unaffected individuals served as controls. Main Outcome Measures: We measured fat mass, by DXA, and bone turnover markers. Results: Amongwomen, fat mass was inversely related to age in controls (P<.01), but not in HBM cases (P<.96) in whom mean fat mass was 8.9 [95% CI 4.7, 13.0] kg higher compared with controls (fully adjusted mean difference, P<.001). Increased fat mass in male HBM cases was less marked (gender interaction P = .03). Compared with controls, lean mass was also increased in female HBM cases (by 3.3 [1.2, 5.4] kg; P<.002); however, lean mass increases wereless marked than fat mass increases, resulting in 4.5% lower percentage lean mass in HBM cases (P<.001). Osteocalcin was also lower in female HBM cases compared with controls (by 2.8 [0.1, 5.5]μg/L; P = .04). Differences in fat mass were fully attenuated after hip bone mineral density (BMD) adjustment (P = .52) but unchanged after adjustment for bone turnover (P < .001), whereas the greater hip BMD in female HBM cases was minimally attenuated by fat mass adjustment (P<.001). Conclusions: HBM is characterized by a marked increase in fat mass in females, statistically explained by their greater BMD, but not by markers of bone turnover. Copyright © 2013 by The Endocrine Society.

LRP5 regulates human body fat distribution by modulating adipose progenitor biology in a dose- and depot-specific fashion

Summary Common variants in WNT pathway genes have been associated with bone mass and fat distribution, the latter predicting diabetes and cardiovascular disease risk. Rare mutations in the WNT co-receptors LRP5 and LRP6 are similarly associated with bone and cardiometabolic disorders. We investigated the role of LRP5 in human adipose tissue. Subjects with gain-of-function LRP5 mutations and high bone mass had enhanced lower-body fat accumulation. Reciprocally, a low bone mineral density-associated common LRP5 allele correlated with increased abdominal adiposity. Ex vivo LRP5 expression was higher in abdominal versus gluteal adipocyte progenitors. Equivalent knockdown of LRP5 in both progenitor types dose-dependently impaired β-catenin signaling and led to distinct biological outcomes: diminished gluteal and enhanced abdominal adipogenesis. These data highlight how depot differences in WNT/β-catenin pathway activity modulate human fat distribution via effects on adipocyte progenitor biology. They also identify LRP5 as a potential pharmacologic target for the treatment of cardiometabolic disorders. © 2015 The Authors.

What the problem may be with family intervention . . . and with dissemination more generally: A commentary

While the two decades since the study by Kavanagh et al. (1993) has given additional insights into effective dissemination of family interventions, the accompanying papers show that progress remains limited. The effectiveness trial that triggered this series of papers offers a cautionary tale. Despite management support, 30–35 hr of workshop training and training of local supervisors who could act as champions, use of the full intervention was limited. In part, this seemed due to the demanding nature of the intervention and its incompatibility with practitioners’ roles, in part, to limitations in the training, among other factors. While the accompanying papers note these and other barriers to dissemination, they miss a more disturbing finding in the original paper: Practitioners said they were using several aspects in routine care, despite being unable to accurately describe what they were. This finding highlights the risks in taking practitioners’ reports of their practice in files or supervision sessions at face value and potentially has implications for reports of other clinical work. The fidelity of disseminated treatments can only be assured by audits of practice, accompanied by affirming but also corrective feedback.

Understanding who cares: Creating the evidence to address the long-standing policy problem of staff shortages in early childhood education and care

Evidence-based policy is a means of ensuring that policy is informed by more than ideology or expedience. However, what constitutes robust evidence is highly contested. In this paper, we argue policy must draw on quantitative and qualitative data. We do this in relation to a long entrenched problem in Australian early childhood education and care (ECEC) workforce policy. A critical shortage of qualified staff threatens the attainment of broader child and family policy objectives linked to the provision of ECEC and has not been successfully addressed by initiatives to date. We establish some of the limitations of existing quantitative data sets and consider the potential of qualitative studies to inform ECEC workforce policy. The adoption of both quantitative and qualitative methods is needed to illuminate the complex nature of the work undertaken by early childhood educators, as well as the environmental factors that sustain job satisfaction in a demanding and poorly understood working environment.

Problem-based learning in an e-learning environment: A case study at Griffith University School of Medicine

Increasing numbers of medical schools in Australia and overseas have moved away from didactic teaching methodologies and embraced problem-based learning (PBL) to improve clinical reasoning skills and communication skills as well as to encourage self-directed lifelong learning. In January 2005, the first cohort of students entered the new MBBS program at the Griffith University School of Medicine, Gold Coast, to embark upon an exciting, fully integrated curriculum using PBL, combining electronic delivery, communication and evaluation systems incorporating cognitive principles that underpin the PBL process. This chapter examines the educational philosophies and design of the e-learning environment underpinning the processes developed to deliver, monitor and evaluate the curriculum. Key initiatives taken to promote student engagement and innovative and distinctive approaches to student learning at Griffith promoted within the conceptual model for the curriculum are (a) Student engagement, (b) Pastoral care, (c) Staff engagement, (d) Monitoring and (e) Curriculum/Program Review. © 2007 Springer-Verlag Berlin Heidelberg.

Understanding data flow and security requirements in wireless Body Area Networks for healthcare

The Body Area Network (BAN) is an emerging technology that focuses on monitoring physiological data in, on and around the human body. BAN technology permits wearable and implanted sensors to collect vital data about the human body and transmit it to other nodes via low-energy communication. In this paper, we investigate interactions in terms of data flows between parties involved in BANs under four different scenarios targeting outdoor and indoor medical environments: hospital, home, emergency and open areas. Based on these scenarios, we identify data flow requirements between BAN elements such as sensors and control units (CUs) and parties involved in BANs such as the patient, doctors, nurses and relatives. Identified requirements are used to generate BAN data flow models. Petri Nets (PNs) are used as the formal modelling language. We check the validity of the models and compare them with the existing related work. Finally, using the models, we identify communication and security requirements based on the most common active and passive attack scenarios.