Calling for help : a responsive evaluation of Child Health Line

The project examined the responsiveness of the telenursing service provided by the Child Health Line (hereinafter referred to as CHL). It aimed to provide an account of population usage of the service, the call request types and the response of the service to the calls. In so doing, the project extends the current body of knowledge pertaining to the provision of parenting support through telenursing. Approximately 900 calls to the CHL were audio-recorded over the December 2005-2006 Christmas-New Year period. A protocol was developed to code characteristics of the call, the interactional features between the caller and nurse call-taker, and the extent to which there was (a) agreement on problem definition and the plan of action and (b) interactional alignment between nurse and caller. A quantitative analysis examined the frequencies of the main topics covered in calls to the CHL and any statistical associations between types of calls, length of calls and nurse-caller alignment. In addition, a detailed qualitative analysis was conducted on a subset of calls dealing with the nurse management of calls seeking medical advice and information. Key findings include: • Overall, 74% of the calls discussed parenting and child development issues, 48% discussed health/medical issues, and 16% were information-seeking calls. • More specifically: o 21% discussed health/medical and parenting and child development issues. o 3% discussed parenting and information-seeking issues. o 5% discussed health/medical, parenting/development and information issues. o 18% exclusively focussed on health and medical issues and therefore were outside the remit of the intended scope of the CHL. These calls caused interactional dilemmas for the nurse call-takers as they simultaneously dealt with parental expectations for help and the CHL guidelines indicating that offering medical advice was outside the remit of the service. • Most frequent reasons for calling were to discuss sleep, feeding, normative infant physical functions and parenting advice. • The average length of calls to the CHL was 7 minutes. • Longer calls were more likely to involve nurse call-takers giving advice on more than one topic, the caller displaying strong emotions, the caller not specifically providing the reason for the call, and the caller discussing parenting and developmental issues. • Shorter calls were characterised by the nurse suggesting that the child receive immediate medical attention, the nurse emphasising the importance or urgency of the plan of action, the caller referring to or requesting confirmation of a diagnosis, and caller and nurse call-taker discussion of health and medical issues. • The majority of calls, 92%, achieved parent-nurse alignment by the conclusion of the call. However, 8% did not. • The 8% of calls that were not aligned require further quantitative and qualitative investigation of the interactional features. The findings are pertinent in the current context where Child Health Line now resides within 13HEALTH. These findings indicate: 1. A high demand for parenting advice. 2. Nurse call-takers have a high level of competency in dealing with calls about parenting and normal child development, which is the remit of the CHL. 3. Nurse call-takers and callers achieve a high degree of alignment when both parties agree on a course of action. 4. There is scope for developing professional practice in calls that present difficulties in terms of call content, interactional behaviour and call closure. Recommendations of the project: 1. There are numerous opportunities for further research on interactional aspects of calls to the CHL, such as further investigations of the interactional features and the association of the features to alignment and nonalignment. The rich and detailed insights into the patterns of nurse-parent interactions were afforded by the audio-recording and analysis of calls to the CHL. 2. The regular recording of calls would serve as a way of increasing understanding of the type and nature of calls received, and provide a valuable training resource. Recording and analysing calls to CHL provides insight into the operation of the service, including evidence about the effectiveness of triaging calls. 3. Training in both recognising and dealing with problem calls may be beneficial. For example, calls where the caller showed strong emotion, appeared stressed, frustrated or troubled were less likely to be rated as aligned calls. In calls where the callers described being ‘at their wits end’, or responded to each proposed suggestion with ‘I’ve tried that’, the callers were fairly resistant to advice-giving. 4. Training could focus on strategies for managing calls relating to parenting support and advice, and parental well-being. The project found that these calls were more likely to be rated as being nonaligned. 5. With the implementation of 13HEALTH, future research could compare nurse-parent interaction following the implementation of triaging. Of the calls, 21% had both medical and parenting topics discussed and 5.3% discussed medical, parenting and information topics. Added to this, in 12% of calls, there was ambiguity between the caller and nurse call-taker as to whether the problem was medical or behavioural.

The ancient gene C12orf29 : an exploration of its role in the chordate body plan

The sheep (Ovis aries) is commonly used as a large animal model in skeletal research. Although the sheep genome has been sequenced there are still only a limited number of annotated mRNA sequences in public databases. A complementary DNA (cDNA) library was constructed to provide a generic resource for further exploration of genes that are actively expressed in bone cells in sheep. It was anticipated that the cDNA library would provide molecular tools for further research into the process of fracture repair and bone homeostasis, and add to the existing body of knowledge. One of the hallmarks of cDNA libraries has been the identification of novel genes and in this library the full open reading frame of the gene C12orf29 was cloned and characterised. This gene codes for a protein of unknown function with a molecular weight of 37 kDa. A literature search showed that no previous studies had been conducted into the biological role of C12orf29, except for some bioinformatics studies that suggested a possible link with cancer. Phylogenetic analyses revealed that C12orf29 had an ancient pedigree with a homologous gene found in some bacterial taxa. This implied that the gene was present in the last common eukaryotic ancestor, thought to have existed more than 2 billion years ago. This notion was further supported by the fact that the gene is found in taxa belonging to the two major eukaryotic branches, bikonts and unikonts. In the bikont supergroup a C12orf29-like gene was found in the single celled protist Naegleria gruberi, whereas in the unikont supergroup, encompassing the metazoa, the gene is universal to all chordate and, therefore, vertebrate species. It appears to have been lost to the majority of cnidaria and protostomes taxa; however, C12orf29-like genes have been found in the cnidarian freshwater hydra and the protostome Pacific oyster. The experimental data indicate that C12orf29 has a structural role in skeletal development and tissue homeostasis, whereas in silico analysis of the human C12orf29 promoter region suggests that its expression is potentially under the control of the NOTCH, WNT and TGF- developmental pathways, as well SOX9 and BAPX1; pathways that are all heavily involved in skeletogenesis. Taken together, this investigation provides strong evidence that C12orf29 has a very important role in the chordate body plan, in early skeletal development, cartilage homeostasis, and also a possible link with spina bifida in humans.

Development, implementation and evaluation of a cancer survivor self-management care plan

Aim There is a growing population of people with cancer who experience physiological and psychological effects that persist long after treatment is complete. Interventions that enhance survivors’ self-management abilities might help offset these effects. The aim of this pilot study was to develop, implement and evaluate interventions tailored to assist patients to manage post-treatment health issues effectively. Method In this pre-post intervention cohort study, participants were recruited on completion of cancer treatment. Participants recruited preimplementation, who received usual care, comprised the control group. Participants recruited later formed the intervention group. In the intervention group, the Cancer Care Coordinator developed an individualised, structured Cancer Survivor Self-management Care Plan. Participants were interviewed on completion of treatment (baseline) and at three months. Assessments concerned health needs (CaSUN), self-efficacy in adjusting and coping with cancer and health-related quality of life (FACIT-B or FACT-C). The impact of the intervention was determined by independent t-tests of change scores. Results The intervention (n = 32) and control groups (n = 35) were comparable on demographic and clinical characteristics. Sample mean age was 54 + 10 years. Cancer diagnoses were breast (82%) and colorectal (18%). Statistically significant differences (p < 0.05) indicated improvement in the intervention group for: (a) functional well-being, from the FACIT, (Control: M = −0.69, SE = 0.91; Intervention: M = 3.04, SE = 1.13); and (b) self-efficacy in maintaining social relationships, (Control: M = −0.333, SE = 0.33; Intervention: M = 0.621, SE = 0.27). No significant differences were found in health needs, other subscales of quality of life, the extent and number of strategies used in coping and adjusting to cancer and in other domains of self-efficacy. Conclusions While the results should be interpreted with caution, due to the non-randomised nature of the study and the small sample size, they indicate the potential benefits of tailored self-management interventions warrant further investigation in this context.

Characteristics of nontuberculous mycobacteria from a municipal water distribution system and their relevance to human infections

This thesis documented pathogenic species of nontuberculous mycobacteria in the Brisbane water distribution system. When water and shower aerosol strains were compared with human strains of mycobacteria, the study found that the likelihood of acquiring infection from municipal water was specific for four main species. The method for isolation of mycobacteria from water was refined, followed by sampling from 220 sites across Brisbane. A variety of species (incl 15 pathogens) were identified and genotypically compared to human strains. For M. abscessus and M. lentiflavum, water strains clustered with human strains. Pathogenic strains of M. kansasii were found, though non-pathogenic strains dominated. Waterborne strains of M. fortuitum differed to human strains. Extensive home sampling of 20 patients with NTM disease, supported the theory that the risk of acquiring NTM from water or shower aerosols appears species specific for M. avium, M. kansasii, M. lentiflavum and M. abscessus.

Mycobacterium abscessus isolated from municipal water : a potential source of human infection

Background Mycobacterium abscessus is a rapidly growing mycobacterium responsible for progressive pulmonary disease, soft tissue and wound infections. The incidence of disease due to M. abscessus has been increasing in Queensland. In a study of Brisbane drinking water, M. abscessus was isolated from ten different locations. The aim of this study was to compare genotypically the M. abscessus isolates obtained from water to those obtained from human clinical specimens. Methods Between 2007 and 2009, eleven isolates confirmed as M. abscessus were recovered from potable water, one strain was isolated from a rainwater tank and another from a swimming pool and two from domestic taps. Seventy-four clinical isolates referred during the same time period were available for comparison using rep-PCR strain typing (Diversilab). Results The drinking water isolates formed two clusters with ≥97% genetic similarity (Water patterns 1 and 2). The tankwater isolate (WP4), one municipal water isolate (WP3) and the pool isolate (WP5) were distinctly different. Patient isolates formed clusters with all of the water isolates except for WP3. Further patient isolates were unrelated to the water isolates. Conclusion The high degree of similarity between strains of M. abscessus from potable water and strains causing infection in humans from the same geographical area, strengthens the possibility that drinking water may be the source of infection in these patients.

Factors associated with the isolation of Nontuberculous mycobacteria (NTM) from a large municipal water system in Brisbane, Australia

Background Nontuberculous mycobacteria (NTM) are normal inhabitants of a variety of environmental reservoirs including natural and municipal water. The aim of this study was to document the variety of species of NTM in potable water in Brisbane, QLD, with a specific interest in the main pathogens responsible for disease in this region and to explore factors associated with the isolation of NTM. One-litre water samples were collected from 189 routine collection sites in summer and 195 sites in winter. Samples were split, with half decontaminated with CPC 0.005%, then concentrated by filtration and cultured on 7H11 plates in MGIT tubes (winter only). Results Mycobacteria were grown from 40.21% sites in Summer (76/189) and 82.05% sites in winter (160/195). The winter samples yielded the greatest number and variety of mycobacteria as there was a high degree of subculture overgrowth and contamination in summer. Of those samples that did yield mycobacteria in summer, the variety of species differed from those isolated in winter. The inclusion of liquid media increased the yield for some species of NTM. Species that have been documented to cause disease in humans residing in Brisbane that were also found in water include M. gordonae, M. kansasii, M. abscessus, M. chelonae, M. fortuitum complex, M. intracellulare, M. avium complex, M. flavescens, M. interjectum, M. lentiflavum, M. mucogenicum, M. simiae, M. szulgai, M. terrae. M. kansasii was frequently isolated, but M. avium and M. intracellulare (the main pathogens responsible for disease is QLD) were isolated infrequently. Distance of sampling site from treatment plant in summer was associated with isolation of NTM. Pathogenic NTM (defined as those known to cause disease in QLD) were more likely to be identified from sites with narrower diameter pipes, predominantly distribution sample points, and from sites with asbestos cement or modified PVC pipes. Conclusions NTM responsible for human disease can be found in large urban water distribution systems in Australia. Based on our findings, additional point chlorination, maintenance of more constant pressure gradients in the system, and the utilisation of particular pipe materials should be considered.

Improved rural health through a collaborative model of care – qualitative findings

INTRODUCTION Health disparity between urban and rural regions in Australia is well-documented. In the Wheatbelt catchments of Western Australia there is higher incidence and rate of avoidable hospitalisation for chronic diseases. Structured care approach to chronic illnesses is not new but the focus has been on single disease state. A recent ARC Discovery Project on general practice nurse-led chronic disease management of diabetes, hypertension and stable ischaemic heart disease reported improved communication and better medical administration.[1] In our study we investigated the sustainability of such a multi-morbidities general practice –led collaborative model of care in rural Australia. METHODS A QUAN(qual) design was utilised. Eight pairs of rural general practices were matched. Inclusion criteria used were >18 years and capable of giving informed consent, at least one identified risk factor or diagnosed with chronic conditions. Patients were excluded if deemed medically unsuitable. A comprehensive care plan was formulated by the respective general practice nurse in consultation with the treating General Practitioner (GP) and patient based on the individual’s readiness to change, and was informed by available local resource. A case management approach was utilised. Shediaz-Rizkallah and Lee’s conceptual framework on sustainability informed our evaluation.[2] Our primary outcome on measures of sustainability was reduction in avoidable hospitalisation. Secondary outcomes were patients and practitioners acceptance and satisfaction, and changes to pre-determined interim clinical and process outcomes. RESULTS The qualitative interviews highlighted the community preference for a ‘sustainable’ local hospital in addition to general practice. Costs, ease of access, low prioritisation of self chronic care, workforce turnover and perception of losing another local resource if underutilised influenced the respondents’ decision to present at local hospital for avoidable chronic diseases regardless. CONCLUSIONS Despite the pragmatic nature of rural general practice in Australia, the sustainability of chronic multi-morbidities management in general practice require efficient integration of primary-secondary health care and consideration of other social determinants of health. What this study adds: What is already known on this subject: Structured approach to chronic disease management is not new and has been shown to be effective for reducing hospitalisation. However, the focus has been on single disease state. What does this study add: Sustainability of collaborative model of multi-morbidities care require better primary-secondary integration and consideration of social determinants of health.

Heterogeneity of clinical and environmental isolates of Mycobacterium fortuitum using repetitive element sequence-based PCR: municipal water an unlikely source of community-acquired infections

M. fortuitum is a rapidly growing mycobacterium associated with community-acquired and nosocomial wound, soft tissue, and pulmonary infections. It has been postulated that water has been the source of infection especially in the hospital setting. The aim of this study was to determine if municipal water may be the source of community-acquired or nosocomial infections in the Brisbane area. Between 2007 and 2009, 20 strains of M. fortuitum were recovered from municipal water and 53 patients’ isolates were submitted to the reference laboratory. A wide variation in strain types was identified using repetitive element sequence-based PCR, with 13 clusters of ≥2 indistinguishable isolates, and 28 patterns consisting of individual isolates. The clusters could be grouped into seven similar groups (>95% similarity). Municipal water and clinical isolates collected during the same time period and from the same geographical area consisted of different strain types, making municipal water an unlikely source of sporadic human infection.

The 1989 Comprehensive Plan of Action (CPA) and refugee policy in Southeast Asia : twenty years forward what has changed?

In 2012, the only South East Asian countries that have ratified the 1951 Convention relating to the Status of Refugees and the 1967 Protocol Relating to the Status of Refugees (hereafter referred to as the 1951 Convention and 1967 Protocol) is Philippines (signed 1954), Cambodia (signed 1995) and Timor Leste (signed 2001). Countries such as Indonesia, Malaysia and Thailand have annual asylum seeking populations from Myanmar, South Asia and Middle East, that are estimated to be at 15 000-20 000 per country (UNHCR 2012). The lack of a permanent and formal asylum processing process in these countries means that that asylum-seeking populations in the region are reliant on the local offices of the United Nations High Commission for Refugees based in the region to process their claims. These offices rely upon the good will of these governments to have a presence near detection camps and in capital cities to process claims of those who manage to reach the UNHCR representative office. The only burden sharing mechanism within the region primarily exists under the Bali Process on People Smuggling, Trafficking in Persons and Related Transnational Crime (the Bali Process), introduced in 2002. The Bali Process refers to an informal cooperative agreement amongst the states from the Asia-Pacific region, with Australia and Indonesia as the co-chairs, which discusses its namesake: primarily anti-people smuggling activities and migration protocols. There is no provision within this process to discuss the development of national asylum seeking legislation, processes for domestic processing of asylum claims or burden sharing in contrast to other regions such as Africa and South America (i.e. 2009 African Union Convention for the Protection and Assistance of the Internally Displaced, 1969 African Union Convention Governing the Specific Aspects of Refugee Problems in Africa and 1984 Cartagena Declaration on Refugees [Americas]) (PEF 2010: 19).

Better health outcomes for people with physical disabilities in China through audits of mobility related access : a research and implementation need

China has 85 million people with disabilities, 30% of whom have a physical disability(1). Up to 2006, overall disability rates increased by 0.5% per year, more for males and in rural areas, and rates of physical disability increased by 11.2% per year(2). With population ageing the proportion of people with disability will increase even faster. In May 2014 the 67th World Health Assembly adopted a resolution endorsing the WHO Global Disability Action Plan 2014–2021. One of its three objectives is “to remove barriers and improve access to health services and programmes”. Access to transport contributes to positive health outcomes both directly and indirectly (e.g. access to economic opportunities, which is associated with better health)(3). However, once people with physical disabilities leave their dwellings they are confronted with physical barriers to their mobility, ranging from the condition/provision of paths to the cost/availability of transport and access to buildings. In addition, their mobility restrictions increase their vulnerability as road users, exposing them to a higher risk of injury through road crashes. QUT's School of Public Health and Social Work (PHSW) and and Centre for Accident Research and Road Safety-Queensland (CARRS-Q) CARRS-Q have been collaborating on development of a combined disability audit and road safety access tool that can identify transport barriers and safety issues along the routes taken by people with disabilities, to enable prioritisation of actions to address these issues. There are also spin-off benefits for other road users from addressing the rising toll of disability through road crashes in China(4). The tool has undergone initial proof-of-concept testing in India and Viet Nam, and is currently being assessed in Cambodia and Laos. Given the rapid development of China, increases in rates of physical disability and the impacts of an ageing population, it is proposed to establish collaborative research through the Australia-China Centre for Public Health to (1) tailor the combined road safety audit and disability access tool for use in China; (2) evaluate its use on a sample of routes; (3) develop plans for changes to the routes in consultation with local authorities; (4) evaluate the effectiveness of implemented changes in terms of access and health. 1. Zheng, Q, et al, 2014. Health and Quality of Life Outcomes, 12:25. 2. Zheng, X, et al, 2011. Bull World Health Org, 89:788–797. 3. Götschi, T & Kahlmeier, S, 2011. Integrated Transport, Health, and Sustainability Assessment (INTHESA): Final Report. Institute of Social and Preventive Medicine, University of Zurich. 4. Lin, T, et al, 2013. J Public Health, 35:541–547.

Studies of Brisbane municipal water quality using Inductively Coupled Plasma - Mass Spectrometry and Chemometrics

This research established innovative methods and a predictive model to evaluate water quality using the trace element and heavy metal concentrations of drinking water from the greater Brisbane area. Significantly, the combined use of Inductively Coupled Plasma - Mass Spectrometry and Chemometrics can be used worldwide to provide comprehensive, rapid and affordable analyses of elements in drinking water that can have a considerable impact on human health.

How to plan and implement an environmental education program for a conservation area : lessons from Australia and Borneo

The Augo Wetland Forest Park, along with other conservation areas around the world, provides an opportunity for a personal connection with the natural world - an opportunity for creating ways to convince people to reverse the degradation of the planet. In this presentation I use the settings approach, as used by the World Health Organisation in health promotion, as a framework. The WHO’s 1986 Ottawa Charter states that "Health is created and lived by people within the settings of their everyday life; where they learn, work, play, and love." I argue that, similarly, a conservation area provides a setting for people to connect with environmental issues and can be the place where positive behaviours and actions for the environment are created and enacted. In a wired and virtual world, such settings may be the only opportunity some people, especially children, get to connect with the environment. An evidence-based, intentionally designed and implemented environmental education program enhances the opportunities for the personal connection and subsequent action. Planning and implementing an Environmental education program for a conservation area requires an understanding of the principles of three domains: • Environmental Communication • Environmental Education • Environmental Interpretation In this presentation I define these domains and demonstrate how they become interdependent within the context of a particular setting such as a conservation area. I outline the principles of each domain and demonstrate how they can be enacted with reference to environmental education program case studies from settings in Australia and Borneo. The first case study is based around a proposal for a planned residential community at Eden’s Crossing, in Brisbane’s high growth Western corridor. The setting featured a number of important natural and heritage conservation characteristics and the developer wanted to be pro-active in informing the market what this development aims to achieve in terms of innovative community and environmental objectives. By designing an education and interpretation program in line with best practice education and interpretation principles the developers would be assisted in their efforts to build community, preserve heritage, and facilitate environmentally sensitive lifestyles for the future residents of Eden’s Crossing. Above all, the strategy focused on advancing sustainability in a way that made the Eden’s Crossing greenfield development significantly greener. It did this by interacting with prospective purchasers, and building knowledge about sustainability with a view to shaping the future community of Eden’s Crossing in terms of attitudes and behaviours. The second case study is based around the development of the Rainforest Interpretation Centre (RIC), now renamed the Rainforest Discovery Centre, an environmental education facility managed by the Sabah Forestry Department (SFD) and located at the edge of the Kabili-Sepilok Forest Reserve in the East Malaysian state of Sabah (Borneo). This setting is of paramount importance for biodiversity conservation and research and a vital habitat for orang utan. As an Environmental Education Consultant I was tasked with developing an environmental education program for this setting as part of the SFD’s long- term strategy towards sustainable forest management. By employing the principles of Environmental Education and Environmental Interpretation I designed and implemented a program with three major components: • an environmental education component for visiting primary and secondary school groups. • an environmental education component for in-service and pre-service teachers and teacher educators. • a public awareness and environmental interpretation component which caters for the general public and tourists. From these modest beginnings the program has expanded and new facilities have been developed to meet the demands of visitors, teachers and students. The effectiveness of the program can be traced back to the grounding in the principles of best practice environmental education, communication and interpretation.

Implementing improvements to health care services in the US

In a previous blog I was critical of the US health care system for not using cost-effectiveness information to plan their services. Today I’m going to talk about the implementation of innovation in health services, something the US does really well compared to Australia.

A journey access tool to facilitate better health outcomes for people with disabilities

- Background One of the three objectives of the WHO Global Disability Action Plan 2014–2021 is removal of barriers and improved access to health services and programmes. Access to transport contributes to positive health outcomes; however, people with disabilities leaving their dwellings are confronted with barriers to their mobility. Mobility restrictions, sensory or other disabilities increase their vulnerability as road users, exposing them to higher risks of injury. PHSW and CARRS-Q have been collaborating with Handicap International Cambodia (HIC) on a Journey Access Tool (JAT). - Aims Use of the JAT is to (1) Identify transport and journey safety and barriers for people with disability and (2) Evaluation and modification of the tool after trailing to for use by NGOs and government agencies in prioritising actions around barriers. - Methodology The tool has undergone initial proof-of-concept testing in India and Viet Nam, and was trialled in Cambodia in February and May, 2015. Five teams were formed comprising a person with disability (physical, sensory or intellectual), researchers from QUT, staff from HIC, and local university students. The JAT was completed by each team and then discussed and evaluated. Two further Cambodian trials are scheduled for 2015. - Results The JAT is responsive to rural and urban contexts, and has utility for people with different disabilities. Two tools have been developed: a short version for people with a disability to complete independently, or with assistance; and a version for NGOs, DPOs and government. The tool has efficacy for advocacy.   - Conclusion The JAT has potential to assist the Mekong region with: (1) evaluating access for people with disability and other vulnerable members of the community including older people; (2) developing plans for changes to the routes in consultation with local authorities; (3) evaluating the effectiveness of implemented changes in terms of access and health; (4) inputting into policy; (5) The tool can be used for advocacy for change.

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.