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.

Developing within-company information and communication technologies (ICT) innovation diffusion networks : a study of three Australian major contractors

The innovation diffusion and knowledge management literature strongly supports the importance of communities of practice (COP) for enabling knowledge about how to use and adopt innovation initiatives. One of the most powerful tools for innovation diffusion is word-of-mouth wisdom from committed individuals who mentor and support each other. Close proximity for face-to-face interaction is highly effective, however, many organisations are geographically dispersed with projects being virtual linked sub-organisations using ICT to communicate. ICT has also introduced a useful facilitating technology for developing knowledge networks. This paper presents findings from a research program concentrating on ICT innovation diffusion in the Australian construction industry. One way in which ICT diffusion is taking place was found to be through within-company communities of practice. We undertook in-depth unstructured interviews with three of the major 10 to 15 contractors in Australia to discuss their ICT diffusion strategies. We discovered that in all three cases,within company networked communities of practice was a central strategy. Further, effective diffusion of ICT groupware tools can be critical in developing COP where they are geographically dispersed.

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.

A study of Australian company responses to email complaints

As businesses and organisations move online, many question how to use Internet communication tools effectively, such as Web sites and electronic mail (Porter, 2001). Where and how should they invest their time and money in technology? This research explores a small part of this broad question, online complaining and electronic customer service. This paper extends prior US-based research of consumer complaints by email (Strauss and Hill, 2001) in several ways. First, it replicates their research in an Australian setting. Second, this research addresses several future research issues that Strauss and Hill (2001) raised. And third, this paper uses diffusion of innovation (Rogers, 1995) to explain some of the results. The results partially support the findings of Strauss and Hill (2001), take a small step towards further investigation of effective email responses and provide practical suggestions for better email customer service.

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.

Frameworks in regulating company directors : rethinking the philosophical foundations to enhance accountability

Sets out a system of corporate governance regulation, aimed at combining legal and social methods of governing director behaviour and at creating a framework flexible enough to accommodate different business and ethical cultures. Outlines the theoretical basis of corporate governance and the broad responsibilities of directors, and discusses the extent to which they can and should be regulated. Discusses the constitution of a regulatory framework encompassing law, soft law and best practice, and ethics.

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.

Validating the IS-Impact model : two exploratory case studies in China and Malaysia

For over a decade, IT expenditure in China and Malaysia has shown a significant increase, as organisations in these countries are increasingly dependent on information systems (IS) for achieving strategic advantages and business benefits. However, there have been numerous reports of dissatisfaction with IS, and in some cases the effectiveness of the information systems have yet to be reviewed. Two exploratory case studies reported in this paper are the first phase of an overall research in validating the IS-Impact model introduced by Gable, Sedera and Chan in two countries: China and Malaysia. This validation research aims to produce a standard measuring model across different contexts. The purpose of this paper is to present preliminary findings from two exploratory case studies, attempt to test the feasibility of the research design and to investigate applicability of the IS-Impact model in Chinese and Malaysian organisations. Twenty-nine respondents from a Chinese private company and seventeen respondents from a state government in Malaysia were involved in these studies. Findings indicated that most of existing IS-Impact measures are applicable in the study contexts, however, there are some new measures informed by the respondents. Feedback from the case studies also suggested necessary modifications to the Mandarin instrument.

Internships in marketing: Goals, structures and assessment - student, company and academic perspectives

Work-integrated learning in the form of internships is increasingly important for universities as they seek to compete for students, and seek links with industries. Yet, there is surprisingly little empirical research on the details of internships: (1) What they should accomplish? How they should be structure? (3) How students performance should be assess? There is also surprisingly little conceptual analysis of these key issues, either for business internships in general. or for marketing internships in particular. Furthermore, the "answers" on these issues may differ depending upon the perspective if the three stakeholders: students, business managers and university academics. There is not study in the marketing literature which surveys all three groups on these important aspects of internships. To fill these gaps, this paper discusses and analyses internships goals, internship structure, and internship assessment or undergraduate marketing internships, and then reports on a survey of the views of all three stakeholder groups on these issues. There are a considerable variety of approaches for internships, but generally there is consensus among the stake holder groups, with some notable differences. Managerial implication include recognition of the importance of having and academic aspects in internships; mutual understanding concerning needs and constraints; and the requirement that companies, students, and academics take a long-term view of internship programs to achieve mutually beneficial outcomes.

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.