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.

Targeting injury prevention strategies to adolescents of Pacific Islander descent : what will work?

Background: Ethnicity is rarely considered in injury prevention program development, even though this is known to impact on participation in injury risk behaviour. An understanding of injury, risk behaviour and risk and protective factors specific to adolescents of Pacific Islander descent will inform the development of prevention strategies appropriate to this group.----- Aims: To determine patterns of injury and associated risk behaviour among adolescents of Pacific Islander descent, and to understand the risk and protective factors that influence injury rates among this group.----- Methods: A total of 875 Year 9 students from five Queensland high schools completed a survey during health classes. Seventy-one students (n = 38 male) identified as Pacific Islander. The survey consisted of scales examining injury, risk taking behaviour, and relationships with family, school and police.----- Results: The leading causes of injury among adolescents of Pacific Islander descent were sports (48%) and transport (e.g. 45% reported bicycle injuries). Interpersonal violence related injuries were also relatively frequent, with 28% having been injured in a fight. Reports of alcohol use were relatively low (20% c.f. 40% of the remaining sample), however reports of other risk behaviours were relatively high (e.g. 43% c.f. 25% of remaining sample reported a group fight).----- Discussion and conclusions: Conclusions will be drawn regarding risk-related injuries reported by adolescents of Pacific Islander descent and those of other ethnic backgrounds. Additionally, risk and protective factors relating to family, school and police will be explored, in order to inform prevention strategies appropriate to this group.

Mutation frequency of non-ESBL phenotype SENTRY (Asia-Pacific) isolates of Klebsiella pneumoniae conversion to an ESBL positive phenotype

Extended spectrum β-lactamases or ESBLs, which are derived from non-ESBL precursors by point mutation of β-lactamase genes (bla), are spreading rapidly all over the world and have caused considerable problems in the treatment of infections caused by bacteria which harbour them. The mechanism of this resistance is not fully understood and a better understanding of these mechanisms might significantly impact on choosing proper diagnostic and treatment strategies. Previous work on SHV β-lactamase gene, blaSHV, has shown that only Klebsiella pneumoniae strains which contain plasmid-borne blaSHV are able to mutate to phenotypically ESBL-positive strains and there was also evidence of an increase in blaSHV copy number. Therefore, it was hypothesised that although specific point mutation is essential for acquisition of ESBL activity, it is not yet enough, and blaSHV copy number amplification is also essential for an ESBL-positive phenotype, with homologous recombination being the likely mechanism of blaSHV copy number expansion. In this study, we investigated the mutation rate of non-ESBL expressing K. pneumoniae isolates to an ESBL-positive status by using the MSS-maximum likelihood method. Our data showed that blaSHV mutation rate of a non-ESBL expressing isolate is lower than the mutation rate of the other single base changes on the chromosome, even with a plasmid-borne blaSHV gene. On the other hand, mutation rate from a low MIC ESBL-positive (≤ 8 µg/mL for cefotaxime) to high MIC ESBL-positive (≥16 µg/mL for cefotaxime) is very high. This is because only gene copy number increase is needed which is probably mediated by homologous recombination that typically takes place at a much higher frequencies than point mutations. Using a subinhibitory concentration of novobiocin, as a homologous recombination inhibitor, revealed that this is the case.

Assessment for learning revisited : an Asia-Pacific perspective

In March of this year, 2009, the Third International Conference on Assessment for Learning was held in Dunedin, New Zealand. Colleagues from Australia (4), Canada (6), Europe (5), New Zealand (7), United Kingdom (5) and the United States of America (4) met to advance the understanding and practices of Assessment for Learning at all levels of education. An important outcome of this meeting was a position paper on Assessment for Learning (AfL) that has been reproduced with permission in this editorial because of its significance to a recurrent theme of the majority of the articles published in this special Asia-Pacific issue of the journal. The text of this statement is set out in italics below.

Urban growth management for sustainable urbanization : examples from Asia-Pacific city regions

During the past three decades cities in the Asia-Pacific region have undergone massive transformations, characterised by rapid population growth and urbanisation. The rapid pace of globalisation and economic restructuring has resulted in these cities receiving the full impact of urbanisation pressures. In attempting to ease these pressures, major cities have advocated growth management approaches that give particular interest to sustainable urbanization and emphasise compact and optimum development of urban forms. This paper seeks to provide an insight into sustainable urbanisation practice, particularly on the promotion of compact urbanisation within Asia-Pacific’s fastest growing regions. The finding shows that within the context of resource constraints, sustainable urbanisation has been a key factor in the adoption of urban growth management initiatives promoting viable use of scarce resources for urban expansion.

Show me a bad kid and I’ll show you a lousy parent : making parents responsible for youth crime in Australian and Canadian Contexts

This article surveys literature bearing on the issue of parental liability and responsibility for the crimes of young offenders, with a particular focus on comparing different approaches to dealing with the issue in Australia and Canada. This comparative analysis of Australian and Canadian legislative and policy approaches is situated within a broader discussion of arguments about the “punitive turn” in youth justice, responsibilisation, and cross-jurisdictional criminal justice policy transfer and convergence. Our findings suggest that there are significant differences in the manner and extent to which Australia and Canada have invoked parental responsibility laws and policies as part of the solution to dealing with youth crime. We conclude by speculating on some of the reasons for these differences and establishing an agenda for additional needed cross-jurisdictional research. In particular, we argue that it would be fruitful to undertake a cross-jurisdictional study that examines the development and effects of parental responsibility laws across a larger number of different Western countries as well as across individual states and provinces within these national jurisdictions.

Taxonomy and diagnostics of fruit fly infesting Opiine Braconids in Australia and the South Pacific

Opiine wasps (Hymenoptera: Braconidae: Opiinae) are parasitoids of dacine fruit flies (Diptera: Tephritidae: Dacinae), the primary horticultural pests of Australia and the South Pacific. Effective use of opiines for biological control of fruit flies is limited by poor taxonomy and identification difficulties. To overcome these problems, this thesis had two aims: (i) to carry out traditional taxonomic research on the fruit fly infesting opine braconids of Australia and the South Pacific; and (ii) to transfer the results of the taxonomic research into user friendly diagnostic tools. Curated wasp material was borrowed from all major Australian museum collections holding specimens. This was supplemented by a large body of material gathered as part of a major fruit fly project in Papua New Guinea: nearly 4000 specimens were examined and identified. Each wasp species was illustrated using traditional scientific drawings, full colour photomicroscopy and scanning electron microscopy. An electronic identification key was developed using Lucid software and diagnostic images were loaded on the web-based Pest and Diseases Image Library (PaDIL). A taxonomic synopsis and distribution and host records for each of the 15 species of dacine-parasitising opiine braconids found in the South Pacific is presented. Biosteres illusorius Fischer (1971) was formally transferred to the genus Fopius and a new species, Fopius ferrari Carmichael and Wharton (2005), was described. Other species dealt with were Diachasmimorpha hageni (Fullaway, 1952), D. kraussii (Fullaway, 1951), D. longicaudata (Ashmead, 1905), D. tryoni (Cameron, 1911), Fopius arisanus (Sonan, 1932), F. deeralensis (Fullaway, 1950), F. schlingeri Wharton (1999), Opius froggatti Fullaway (195), Psyttalia fijiensis (Fullaway, 1936), P. muesebecki (Fischer, 1963), P. novaguineensis (Szépliget, 1900i) and Utetes perkinsi (Fullaway, 1950). This taxonomic component of the thesis has been formally published in the scientific literature. An interactive diagnostics package (“OpiineID”) was developed, the centre of which is a Lucid based multi-access key. Because the diagnostics package is computer based, without the space limitations of the journal publication, there is no pictorial limit in OpiineID and so it is comprehensively illustrated with SEM photographs, full colour photographs, line drawings and fully rendered illustrations. The identification key is only one small component of OpiineID and the key is supported by fact sheets with morphological descriptions, host associations, geographical information and images. Each species contained within the OpiineID package has also been uploaded onto the PaDIL website (www.padil.gov.au). Because the identification of fruit fly parasitoids is largely of concern to fruit fly workers, rather than braconid specialists, this thesis deals directly with an area of growing importance to many areas of pure and applied biology; the nexus between taxonomy and diagnostics. The Discussion chapter focuses on this area, particularly the opportunities offered by new communication and information tools as new ways delivering the outputs of taxonomic science.

Finding hy-Brazil : eugenics and modernism in the Pacific

In the 1930s a number of Australian women writers took issue with material and symbolic aspects of public health discourse and in particular challenged institutional endorsement of eugenicist movements. This paper discusses the response of inter-war women writers to the national discussion of science and medicine and, in particular, eugenics.

Asia-Pacific Spatial Excellence Awards WINNERS for 2009

Listing of Asia-Pacific Award winners and award nomination documentation for APSEA education an professional development, includes acceptance speech and photos

“Show me a bad kid and I’ll show you a lousy parent” : making parents responsible for youth crime in Australian and Canadian contexts

In this article we survey relevant international literature on the issue of parental liability and responsibility for the crimes of young offenders. In addition, as a starting point for needed cross-jurisdictional research, we focus on different approaches that have been taken to making parents responsible for youth crime in Australia and Canada. This comparative analysis of Australian and Canadian legislative and policy approaches is situated within a broader discussion of arguments about parental responsibility, the ‘punitive turn’ in youth justice, and cross-jurisdictional criminal justice policy transfer and convergence. One unexpected finding of our literature survey is the relatively sparse attention given to the issue of parental responsibility for youth crime in legal and criminological literature compared to the attention it receives in the media and popular-public culture. In Part I we examine the different views that have been articulated in the social science literature for and against parental responsibility laws, along with arguments that have been made about why such laws have been enacted in an increasing number of Western countries in recent years. In Part II, we situate our comparative study of Australian and Canadian legislative and policy approaches within a broader discussion of arguments about the ‘punitive turn’ in youth justice, responsibilisation, and cross-jurisdictional criminal justice policy transfer and convergence. In Part III, we identify and examine the scope of different parental responsibility laws that have been enacted in Australia and Canada; noting significant differences in the manner and extent to which parental responsibility laws and policies have been invoked as part of the solution to dealing with youth crime. In our concluding discussion, in Part IV, we try to speculate on some of the reasons for these differences and set an agenda for needed future research on the topic.

Comparison of U.S., Canadian, and Australian participants' performance on the Algase Wandering Scale-Version 2 (AWS-V2)

Background Wandering represents a major problem in the management of patients with Alzheimer’s disease (AD). In this study we examined the utility of the Algase Wandering Scale (AWS), a newly developed psychometric instrument that asks caregivers to assess the likelihood of wandering behavior. Methods The AWS was administered to the caregivers of 40 AD patients and total and subscale scores were examined in relation to measures of mental and functional status, depressive symptoms and medication usage. Results AWS scores were comparable, though slightly lower, than those normative values previously published. Higher scores were associated with more severe dementia. The Negative Outcome subscale showed a significant increase in reported falls or injuries in association with anti-depressant use. Conclusions These data provide some construct validation for the AWS as a potentially useful scale to assess wandering behaviors in AD.

Struggles Over Difference: Curriculum, texts and pedagogy in the Asia-Pacific

Struggles over Difference addresses education, schools, textbooks, and pedagogies in various countries of the Asia-Pacific, offering critical curriculum studies and policy analyses of national and regional educational systems. These systems face challenges linked to new economic formations, cultural globalization, and emergent regional and international geopolitical instabilities and conflicts. Contributors offer insights on how official knowledge, text, discourse and discipline should be shaped; who should shape it; through which institutional agencies it should be administered: and social and cultural practices through which this should occur.