Pacific Rim treaty threatens public health: Patent law and medical procedures

Doctors, surgeons, and physicians around the Pacific Rim should be concerned by the proposals revealed by WikiLeaks in the Trans-Pacific Partnership (TPP). One of the most controversial features of the TPP is the proposal to provide for patent protection in respect of medical procedures. As Public Citizen observed, ‘Health providers, including surgeons, could be liable for the methods they use to treat patients.’ The civil society group noted: ‘Essentially, except for when a surgeon uses her bare hands, surgical methods would be patentable under the U.S. proposal.’ The TPP takes a broad approach to patents and medicine; lacks appropriate safeguards; and fails to address larger questions about equity, development, and human rights. Such a measure could result in greater litigation against medical professionals; barriers to access to medical procedures for patients; and skyrocketing health costs.

ACIAR Improving soil health in support of sustainable development in the Pacific

The proposed project focuses on developing research-based indicators that growers and extensionists can use to assess soil health status (including key chemical, physical and biological variables), as well as extension approaches to communicate soil health.

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.

Report of the Study Group on “Ecosystem-Based Management Science and its application to the North Pacific”

EXECUTIVE SUMMARY INTRODUCTION OVERVIEW OF INTERNATIONAL EBM HISTORY References CANADA Overview Activities to date Integrated Management implementation in Canada Objectives, indicators and reference points Assessment approaches Research directions for the future Management directions for the future References JAPAN Overview Conservation and sustainable use of marine living resources Harvest control by TAC system Stock Recovery Plan and effort regulation system Stock enhancement by hatchery-produced juvenile release Conservation and sustainable develop-ment on coastal waters The implementation of ecosystem-based management PEOPLE’S REPUBLIC OF CHINA Overview Current actions Output control Input control Summer fishing ban Enhance ecosystem health REPUBLIC OF KOREA Initiatives and actions of ecosystem-based management in Korea Current ecosystem-based management initiatives in Korea Precautionary TAC-based fishery management Closed fishing season/areas Fish size- and sex-controls Fishing gear design restrictions Marine protected areas (MPA) RUSSIA Existing and anticipated ecosystem-based management initiatives Issues related to the implementation of ecosystem-based management UNITED STATES OF AMERICA Definitions and approaches to ecosystem-based fishery management in the United States Present U.S. legislative mandates relating to ecosystem-based fishery management Target species Bycatch species Threatened or endangered species Habitats Food webs Ecosystems Integration of legislative mandates into an ecosystem approach Scientific issues in implementing ecosystem-based approaches References DISCUSSION AND RECOMMENDATIONS APPENDICES Appendix 10.1 Study group membership and participants Appendix 10.2 Terminology definitions Appendix 10.3 Present state of implementing ecosystem-based fishery management in Alaska: Alaska groundfish fisheries Appendix 10.4 Present state of implementing ecosystem-based fishery management off the West Coast of the United States: Pacific Coast groundfish fisheries Appendix 10.5 Descriptions of multi-species and ecosystem models developed or under development in the U.S. North Pacific region that might be used to predict effects of fishing on ecosystems Appendix 10.6 A potential standard reporting format (developed by Australia, and currently being used by the U.S.A in their contribution to this report) (83 page document)

Coral health and disease in the Pacific: vision for action

Shallow coral reefs in the IndoPacific contain the highest diversity of marine organisms in the world, with approximately 1500 described species of fish, over 500 species of scleractinian corals, and an estimated 1-10 million organisms yet to be characterized (Reaka-Kudla et al. 1994). These centers of marine biodiversity are facing significant, multiple threats to reef community and habitat structure and function, resulting in local to wide-scale regional damage. Wilkinson (2004) characterized the major pressures as including (1) global climate change, (2) diseases, plagues and invasive species, (3) direct human pressures, (4) poor governance and lack of political will, and (5) international action or inaction. Signs that the natural plasticity of reef ecosystems has been exceeded in many areas from the effects of environmental (e.g., global climate change) and anthropogenic (e.g., land use, pollution) stressors is evidenced by the loss of 20% of the world’s coral reefs (Wilkinson 2004). Predictions are that another 24% (Wilkinson 2006) are under imminent risk of collapse and an additional 26% are under a longer term threat from reduced fitness, disease outbreaks, and increased mortality. These predictions indicate that the current list of approximately 30-40 fatal diseases impacting corals will expand as will the frequency and extent of “coral bleaching” (Waddell 2005; Wilkinson 2004). Disease and corallivore outbreaks, in combination with multiple, concomitant human disturbances are compromising corals and coral reef communities to the point where their ability to rebound from natural disturbances is being lost.

Systematically retrieving research in the digital age: Case study on the topic of social networking sites and young people’s mental health

Online information seeking has become normative practice among both academics and the general population. This study appraised the performance of eight databases to retrieve research pertaining to the influence of social networking sites on the mental health of young people. A total of 43 empirical studies on young people’s use of social networking sites and the mental health implications were retrieved. Scopus and SSCI had the highest sensitivity with PsycINFO having the highest precision. Effective searching requires large
generic databases, supplemented by subject-specific catalogues. The methodology developed here may provide inexperienced searchers, such as undergraduate students, with a framework to define a realistic scale of searching to undertake for a particular literature review or similar project.

Oral health in transition: the case of Indigenous peoples from Brazil

The objective of this paper is to summarise epidemiological information about the distribution of dental caries among Indigenous peoples in Brazil. The authors also present a case study of a specific group of Xavante Indians, one of the most numerous of Brazil`s Indigenous peoples, describing how their oral health has deteriorated over recent decades, and showing how an oral health programme is attempting to reverse the present trend of increase in caries. The programme at Etenheritipa Xavante village incorporated three principal components: educational, preventive, and clinical. From the beginning, the programme included epidemiological record keeping for monitoring the level of caries in the population. Transversal studies of the condition of oral health among the Xavante of Etenheritipa were undertaken in 1999, 2004, and 2007. In the period from 2004 to 2007 the DMFS values in the 11-15 age cohort had a significant reduction in caries experience. The mean DMFS score fell from 4.95 in 2004 to 2.39 in 2007 (p<0.01). An increase in the percent of individuals who were free from caries was also noted: in 1999, 20% of adolescents 11-15 had no caries; in 2007, the proportion had risen to 47%. The Xavante case is a prime example of the transition in oral health that is taking place among the Indigenous peoples of the Americas, and it highlights the importance of oral health promotion through preventive measures such as access to fluoridation and basic care in reducing the inequality between Indians and non-Indians.

Health and quality of care from older peoples' and formal caregivers' perspective

Aim: The overall aim of this thesis was to gain a deeper understanding of older people's view of health and care while dependent on community care. Furthermore to describe and compare formal caregivers' perceptions of quality of care, working conditions, competence, general health, and factors associated with quality of care from the caregivers' perspective. Method: Qualitative interviews were conducted with 19 older people in community care who were asked to describe what health and ill health((I), good and bad care meant for them (II). Data were analyzed using content analysis (I) and a phenomenological analysis (II). The formal caregivers; 70 nursing assistants (NAs) 163 enrolled nurses (ENs) and 198 registered nurses (RNs), answered a questionnaire consisting of five instruments: quality of care from the patient's perspective modified to formal caregivers, creative climate questionnaire, stress of conscience, health index, sense of coherence and items on education and competence (III). Statistical analyses were performed containing descriptive statistics, and comparisons between the occupational groups were made using Kruskal-Wallis ANOVA, Mann-Whitney U-test and Pearson's Chi-square test (III). Pearson's  product moment correlation analysis and multiple regression analysis were performed studying the associations between organizational climate, stress of conscience, competence, general health and sense of coherence with quality of care (IV). Results: The older people's health and well-being were related to their own ability to adapt to and compensate for their disabilities and was described as negative and positive poles of autonomy vs. dependence, togetherness vs. being an onlooker, security vs. insecurity and tranquility vs. disturbance (I).  The meaning of good care (II) was that the formal caregivers respected the older people as unique individuals, having the opportunity to live their lives as usual and receiving a safe and secure care. Good care could be experienced when the formal caregivers had adequate knowledge and competence in caring for older people, adequate time and continuity in the care organization (II). Formal caregivers reported higher perceived quality of care in the dimensions medical-technical competence and physical-technical conditions than in identity-oriented approach and socio-cultural atmosphere (III). In the organizational climate three of the dimensions were close to the value of a creative climate and in seven near a stagnant climate. The formal caregivers reported low rate of stress of conscience. The RNs reported to a higher degree than the NAs/ENs a need to gain more knowledge, but the NAs and the ENs more often received training during working hours. The RNs reported lower emotional well-being than the NAs/ENs (III). The formal caregivers' occupation, organizational climate and stress of conscience were associated with perceived quality of care (IV). Implications: The formal caregivers should have an awareness of the importance of kindness and respect, supporting the older people to retain control over their lives. The nursing managers should employ highly competent and adequate numbers of skilled formal caregivers, organize formal caregivers having round the clock continuity. Improvements of organizational climate and stress of conscience are of importance for good quality of care.

Young peoples’ entrance to the workplace : Introduction to occupational health and safety

Negative outcomes of a poor work environment are more frequent among young workers. The aim of the current study was to study former pupils’ conditions concerning occupational health and safety by investigating the workplaces’, safety climate, the degree of implementation of SWEM and the their introduction programs. Four branches were included in the study: Industrial, Restaurant, Transport and Handicraft, specialising in wood. Semi-structured dialogues were undertaken with 15 employers at companies in which former pupils were employed. They also answered a questionnaire about SWEM. Former pupils and experienced employees were upon the same occasion asked to fill in a questionnaire about safety climate at the workplace. Workplace introduction programs varied and were strongly linked to company size. Most of the former pupils and experienced employees rated the safety climate at their company as high, or good. Employers in three of the branches rated the SWEM implemented at their workplaces to be effective. The Industry companies, which had the largest workplaces, gave the most systematic and workplace introduction for new employees. There are no results from this study explaining the fact that young workers have a higher risk for workplace accidents.

Globalisation, food and health in Pacific Island countries

Pacific Island countries (PICs) are experiencing an epidemic of obesity and consequent chronic diseases. Despite investment in the development of National Plans of Action for Nutrition (NPANs) and interventions to promote healthy eating and physical activity, nutritional status appears to show little improvement. This paper presents a synthesis of the findings from two research papers that were prepared for a 2003 food safety and quality meeting in Nadi, Fiji. The findings indicate that although lifestyle behaviours might be the immediate cause of dietary imbalances, greater attention should focus on omnipresent influences of globalisation as a critical element of the nutrition transition in the Pacific. In particular, those aspects of globalisation mediated through the World Trade Organization (WTO) Agreements that are placing pressures on food security and fostering increased dependence on imported food of poor nutritional quality. Rapid, significant and sustainable improvements in public health in PICs require interventions that can tackle these underlying contributors to ill health. There are opportunities to explore the use of food regulatory approaches to influence the composition, availability and accessibility of food products. Within the context of the WTO Agreements the legitimacy of food regulatory approaches will depend upon the case to demonstrate the relationship between the intervention and the protection of food security and public health nutrition. The challenges in realising these opportunities are: 1) to have the capacity to construct a case, 2) meet the technical and financial demands to administer and enforce regulatory approaches, and 3) to take advantage of opportunities available and to be able to fully participate in the international policy-making process.

Predicting time trade-off health state valuations of adolescents in four Pacific countries using the assessment of quality-of-life (AQoL-6D) instrument

Objectives: Pacific Obesity Prevention in Communities (OPIC) is a community-based intervention project targeting adolescent obesity in Australia, New Zealand, Fiji, and Tonga. The Assessment of Quality of Life Mark 2 (AQoL-6D) instrument was completed by 15,481 adolescents to obtain a description of the quality of life associated with adolescent overweight and obesity, and a corresponding utility score for use in a cost–utility analysis of the interventions. This article describes the recalibration of this utility instrument for adolescents in each country.

Methods: The recalibration was based on country-specific time trade-off (TTO) data for 30 multiattribute health states constructed from the AQoL-6D descriptive system. Senior secondary students, in a classroom setting, responded to 10 health state scenarios each. These TTO interviews were conducted for 24 groups, comprising 279 students in the four countries resulting in 2790 completed TTO scores. The TTO scores were econometrically transformed by regressing the TTO scores upon predicted scores from the AQoL-6D to produce country-specific algorithms. The latter incorporated country-specific “corrections” to the Australian adult utility weights in the original AQoL.

Results: This article reports two methodological elements not previously reported. The first is the econometric modification of an extant multi-attribute utility instrument to accommodate cultural and other group-specific differences in preferences. The second is the use of the TTO technique with adolescents in a classroom group setting. Significant differences in utility scores were found between the four countries.

Conclusion: Statistical results indicate that the AQoL-6D can be validly used in the economic evaluation of both the OPIC interventions and other adolescent programs.