New Functional Biomaterials for Medicine and Healthcare

The book begins with an overview of the use of biomaterials in contemporary healthcare and the process of developing novel biomaterials; the key issues and challenges associated with the design of complex implantable systems are also highlighted. The book then reviews the main materials used in functional biomaterials, particularly their properties and applications. Individual chapters focus on both natural and synthetic polymers, metallic biomaterials, and bio-inert and bioactive ceramics.

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.

Cost-effectiveness of a national initiative to improve hand hygiene compliance using the outcome of healthcare associated staphylococcus aureus bacteraemia

Background The objective is to estimate the incremental cost-effectiveness of the Australian National Hand Hygiene Inititiave implemented between 2009 and 2012 using healthcare associated Staphylococcus aureus bacteraemia as the outcome. Baseline comparators are the eight existing state and territory hand hygiene programmes. The setting is the Australian public healthcare system and 1,294,656 admissions from the 50 largest Australian hospitals are included. Methods The design is a cost-effectiveness modelling study using a before and after quasi-experimental design. The primary outcome is cost per life year saved from reduced cases of healthcare associated Staphylococcus aureus bacteraemia, with cost estimated by the annual on-going maintenance costs less the costs saved from fewer infections. Data were harvested from existing sources or were collected prospectively and the time horizon for the model was 12 months, 2011–2012. Findings No useable pre-implementation Staphylococcus aureus bacteraemia data were made available from the 11 study hospitals in Victoria or the single hospital in Northern Territory leaving 38 hospitals among six states and territories available for cost-effectiveness analyses. Total annual costs increased by $2,851,475 for a return of 96 years of life giving an incremental cost-effectiveness ratio (ICER) of $29,700 per life year gained. Probabilistic sensitivity analysis revealed a 100% chance the initiative was cost effective in the Australian Capital Territory and Queensland, with ICERs of $1,030 and $8,988 respectively. There was an 81% chance it was cost effective in New South Wales with an ICER of $33,353, a 26% chance for South Australia with an ICER of $64,729 and a 1% chance for Tasmania and Western Australia. The 12 hospitals in Victoria and the Northern Territory incur annual on-going maintenance costs of $1.51M; no information was available to describe cost savings or health benefits. Conclusions The Australian National Hand Hygiene Initiative was cost-effective against an Australian threshold of $42,000 per life year gained. The return on investment varied among the states and territories of Australia.

An online community designed to support future makers in educational reform

Australian education is undergoing national reform at many levels. The school sector, where preservice teachers will be employed, are adjusting to the demands of the National Curriculum and improving teacher quality through the National Professional Standards for Teachers. In addition, the university sector, where pre-service teachers are prepared, is undergoing its own education reform through the introduction of a demand-driven system and ensuring quality for tertiary education interns through the Higher Education Standards Framework. In moving to prepare preservice teachers for the school system; universities are grappling with the double-barreled approach to teacher quality; quality within the university course and quality within the student teachers being prepared. Through a collaborative partnership including university lecturers, Department of Education central administration staff, school principals, school coordinators, practicum supervisors, mentor teachers and pre-service teachers; the stakeholders have formed an online community of learners engaging in reflective practice who are committed to improving teacher quality. This online community not only links the key stakeholders within the project, it facilitates the nexus between theory and practice often missing in our pre-service teacher placements. This paper reports preliminary data about an initiative to ensure final year pre-service teachers are aspiring to meet the graduate professional standards through the use of an innovative online community.

Rationing in healthcare

Rationing healthcare in some form is inevitable, even in wealthy countries, because resources are scarce and demand for healthcare is always likely to exceed supply. This means that decision-makers must make choices about which health programs and initiatives should receive public funding and which ones should not. These choices are often difficult to make, particularly in Australia, because: - 1 Make explicit rationing based on a national decision-making tool (such as Multi-criteria Decision Analysis) standard process in all jurisdictions. - 2 Develop nationally consistent methods for conducting economic evaluation in health so that good quality evidence on the relative efficiency of various programs and initiatives is generated. - 3 Generate more economic evaluation evidence to inform rationing decisions. - 4 Revise national health performance indicators so that they include true health system efficiency indicators, such as cost-effectiveness. - 5 Apply the Comprehensive Management Framework used to evaluate items on the Medicare Benefits Schedule (MBS) to the Pharmaceutical Benefits Scheme (PBS) and the Prosthesis List to accelerate disinvestment from low-value drugs and prostheses. - 6 Seek agreement among Commonwealth, state and territory governments to work together to undertake work similar to the National Institute for Health and Care Excellence in the United Kingdom and the Canadian Agency for Drugs and Technologies in Health.

Making decisions about antibiotic use in the Australian primary healthcare sector

Background Australia has one of the highest rates of antibiotic use amongst OECD countries. Data from the Australian primary healthcare sector suggests unnecessary antibiotics were prescribed for self-resolving conditions. We need to better understand what drives general practitioners (GPs) to prescribe antibiotics, consumers to seek antibiotics, and pharmacists to fill repeat antibiotic prescriptions. It is also not clear how these individuals trade-off between the possible benefits that antibiotics may provide in the immediate/short term, against the longer term societal risk of antimicrobial resistance. This project investigates what factors drive decisions to use antibiotics for GPs, pharmacists and consumers, and how these individuals discount the future. Methods Factors will be gleaned from published literature and from semi-structured interviews, to inform the development of Discrete Choice Experiments (DCEs). Three DCEs will be constructed – one for each group of interest – to allow investigation of which factors are more important in influencing (a) GPs to prescribe antibiotics, (b) consumers to seek antibiotics, and (c) pharmacists to fill legally valid but old or repeat prescriptions of antibiotics. Regression analysis will be conducted to understand the relative importance of these factors. A Time Trade Off exercise will be developed to investigate how these individuals discount the future. Results Findings from the DCEs will provide an insight into which factors are more important in driving decision making in antibiotic use for GPs, pharmacists and consumers. Findings from the Time Trade Off exercise will show what individuals are willing to trade for preserving the miracle of antibiotics. Conclusion Research findings will contribute to existing national programs to bring about a reduction in inappropriate use of antibiotic in Australia. Specifically, influencing how key messages and public health campaigns are crafted, and clinical education and empowerment of GPs and pharmacists to play a more responsive role as stewards of antibiotic use in the community.

Developing nations need more than words from G20 tax reform

Tax reform is squarely on the agenda for the G20 Brisbane summit in November. The current international tax regime is broken and it’s going to take significant effort on a global scale to fix it. In a recently released CEDA Report on securing the G20’s future, I recommended the role Australia could play in ensuring real and substantive progress is made in international tax reform. There’s a very real need to ensure the Brisbane summit is not just a “talkfest”. One group that stands to significantly win or lose from reform, or lack of it, is developing nations.

G20 tax reform plan should prevent another Lux leaks

The G20 Communique is good news on the international tax reform front. As part of the G20 commitment to boost economic resilience the Communique commits G20 nations to taking action to ensure fairness in the international tax system. This means they are looking at ways to ensure profits are taxed where economic activities deriving the profits are performed and where value is created.

On the tying of aid to tariff reform

This paper considers the welfare effects of foreign aid that is tied to changes in the recipient's tariff. By constructing a three-country model with tariffs, and by allowing for changes both in the amount of aid and in the tariff rates, we are able to consider the welfare implications of two different rules of aid conditionality: (i) a rule which leaves the donor's welfare unchanged, and (ii) a rule which leaves the recipient government's total revenue unchanged. It is shown that the tying of aid to a tariff reform can, inter alia, be used to ensure Pareto improvement.

Steepest ascent tariff reform

The policy reform literature is primarily concerned with the construction of reforms that yield welfare gains. By contrast, this paper’s contribution is to develop a theoretical concept for which the focus is upon the sizes of welfare gains accruing from policy reforms rather than upon their signs. In undertaking this task, and by focusing on tariff reforms, we introduce the concept of a steepest ascent policy reform, which is a locally optimal reform in the sense that it achieves the highest marginal gain in utility of any feasible local reform. We argue that this reform presents itself as a natural benchmark for the evaluation of the welfare effectiveness of other popular tariff reforms such as the proportional tariff reduction and the concertina rules, since it provides the maximal welfare gain of all possible local reforms. We derive properties of the steepest ascent tariff reform, construct an index to measure the relative welfare effectiveness of any given tariff reform, determine conditions under which proportional and concertina reforms are locally optimal and provide illustrative examples.

A preliminary analysis of Australian Government’s Indigenous reform agenda ‘Closing the Gap’ and corporate accountability

This chapter provides a preliminary analysis of Australian Government’s reform agenda popularly known as ‘Closing the Gap’.” Closing the Gap” sets a commitment by all Australian governments to improve the lives of Indigenous Australians, and in particular provide a better future for indigenous children. This article discusses how the coalition of Australian Governments prepared this agenda and how this program involves Australian corporations in this task. Our observations suggest that another reform is required for the government to mandate corporate involvement and contribution to this reform agenda.

Health complaints and regulatory reform: Implications for vulnerable populations?

Complaints and disciplinary processes play a significant role in health professional regulation. Many countries are transitioning from models of self-regulation to greater external oversight through systems including meta regulation, responsive (risk–based) regulation, and “networked governance”. Such systems harness, in differing ways, public, private, professional and non-governmental bodies to exert influence over the conduct of health professionals and services. Interesting literature is emerging regarding complainants’ motivations and experiences, the impact of complaints processes on health professionals and identification of features such as complainant and health professional profiles, types of complaints and outcomes. This paper concentrates on studies identifying vulnerable groups and their participation in health care regulatory systems.

Healthcare-Associated Infections in Pediatrics

Healthcare-associated infections (HAIs) are known to increase the risk for patient morbidity and mortality in different healthcare settings and thereby to cause additional costs. HAIs typically affect patients with severe underlying conditions. HAIs are prevalent also among pediatric patients, but the distribution of the types of infection and the causative agents differ from those detected in adults. The aim of this study was to obtain information on pediatric HAIs in Finland through an assessment of the surveillance of bloodstream infections (BSIs), through two outbreak investigations in a neonatal intensive care unit (NICU), and through a study of postoperative HAIs after open-heart surgery. The studies were carried out at the Hospital for Children and Adolescents of Helsinki University Central Hospital. Epidemiological features of pediatric BSIs were assessed. For the outbreak investigations, case definitions were set and data collected from microbiological and clinical records. The antimicrobial susceptibilities of the Serratia marcescens and the Candida parapsilosis isolates were determined and they were genotyped. Patient charts were reviewed for the case-control and cohort studies during the outbreak investigations, as well as for the patients who acquired surgical site infections (SSIs) after having undergone open-heart surgery. Also a prospective postdischarge study was conducted to detect postoperative HAIs in these patients. During 1999-2006, the overall annual BSI rate was 1.6/1,000 patient days (range by year, 1.2–2.1). High rates (average, 4.9 and 3.2 BSIs/1,000 patient days) were detected in hematology and neonatology units. Coagulase-negative staphylococci were the most common pathogens both hospital-wide and in each patient group. The overall mortality was 5%. The genotyping of the 15 S. marcescens isolates revealed three independent clusters. All of the 26 C. parapsilosis isolates studied proved to be indistinguishable. The NICU was overcrowded during the S. marcescens clusters. A negative correlation between C. parapsilosis BSIs and fluconazole use in the NICU was detected, and the isolates derived from a single initially susceptible strain became less susceptible to fluconazole over time. Eighty postoperative HAIs, including all severe infections, were detected during hospitalization after open-heart surgery; 34% of those HAIs were SSIs and 25% were BSIs. The postdischarge study found 65 infections that were likely to be associated with hospitalization. The majority (89%) of them were viral respiratory or gastrointestinal infections, and these often led to rehospitalizations. The annual hospital-wide BSI rates were stable, and the significant variation detected in some units could not be seen in overall rates. Further studies with data adequately adjusted for risk factors are needed to assess BSI rates in the patient groups with the highest rates (hematology, neonatology). The outbreak investigations showed that horizontal transmission was common in the NICU. Overcrowding and lapses in hand hygiene probably contributed to the spreading of the pathogens. Following long-term use of fluconazole in the NICU, resistance to fluconazole developed in C. parapsilosis. Almost one-fourth of the patients who underwent open-heart surgery acquired at least one HAI. All severe HAIs were detected during hospitalization. The postdischarge study found numerous viral infections, which often caused rehospitalization.