Journal articles on the topic 'Drugs – Costs – Australia'

Objective Little data is in existence about the most cost-effective primary treatment for Graves’ disease. We performed a cost–utility analysis comparing radioactive iodine (RAI), anti-thyroid drugs (ATD) and total thyroidectomy (TT) as first-line therapy for Graves’ disease in England and Australia. Methods We used a Markov model to compare lifetime costs and benefits (quality-adjusted life-years (QALYs)). The model included efficacy, rates of relapse and major complications associated with each treatment, and alternative second-line therapies. Model parameters were obtained from published literature. One-way sensitivity analyses were conducted. Costs were presented in 2015£ or Australian Dollars (AUD). Results RAI was the least expensive therapy in both England (£5425; QALYs 34.73) and Australia (AUD5601; 30.97 QALYs). In base case results, in both countries, ATD was a cost-effective alternative to RAI (£16 866; 35.17 QALYs; incremental cost-effectiveness ratio (ICER) £26 279 per QALY gained England; AUD8924; 31.37 QALYs; ICER AUD9687 per QALY gained Australia), while RAI dominated TT (£7115; QALYs 33.93 England; AUD15 668; 30.25 QALYs Australia). In sensitivity analysis, base case results were stable to changes in most cost, transition probabilities and health-relative quality-of-life (HRQoL) weights; however, in England, the results were sensitive to changes in the HRQoL weights of hypothyroidism and euthyroidism on ATD. Conclusions In this analysis, RAI is the least expensive choice for first-line treatment strategy for Graves’ disease. In England and Australia, ATD is likely to be a cost-effective alternative, while TT is unlikely to be cost-effective. Further research into HRQoL in Graves’ disease could improve the quality of future studies.

Despite seventy years of increasing restrictions, and in the case of heroin almost forty years of absolute prohibition, by all measures the consumption of illegal drugs in Australia has continued to grow. Despite — or perhaps because of — these policies, the costs of enforcement borne by the taxpayer and other costs borne by residents at large have continued to grow. The AIDS epidemic exposed injecting drug users (IDUs) and their partners to the risk of HIV infection, a further cost, but it has encouraged discussion of the effectiveness of the existing policy and the feasibility of alternatives. This study is an attempt to put dollar amounts on these costs, and to estimate how they would change under an alternative policy of drug use regulation. We argue that the recent Cleeland Report underestimates the true costs of the law enforcement against illicit drug use by a factor of at least two. We estimate a total annual cost of existing drug laws in 1987–88 to Australia of $950 million, as well as forced transfers of $656 million.

Objective: Atypical antipsychotic medications that are primarily used to treat schizophrenia and bipolar disorder cost the Pharmaceutical Benefits Scheme (PBS) AUD$334.4m in 2007. There are indications that they have also been used outside the approved indications to treat behavioural disturbances in the elderly. The aim of the present study was therefore to examine (i) trends in prescribing of subsidized atypical antipsychotic drugs in the Australian population from 2002 to 2007; and (ii) gender and age differences in the utilization of these drugs. Methods: Government (Medicare Australia) data on numbers of prescriptions, quantity and doses for atypical and typical antipsychotics from 2002 to 2007 were analysed. Defined daily dose per 1000 population per day were estimated for age and sex groups using Australian Bureau of Statistics population data. Results: The proportion of prescribed antipsychotics that were atypical increased from 61% in 2002 to 77% in 2007. In male subjects, olanzapine was most often prescribed between the ages of 25 and 55 years. In female subjects, in contrast, the highest rates of prescribing were in those ≥75 years. Lower doses of these drugs were prescribed in older adults. Conclusions: Atypical antipsychotic drugs were most commonly used to treat schizophrenia in younger men and behavioural disturbances in older women with dementia. They appear to have been used outside of the approved indication for schizophrenia and bipolar disorder with significant financial costs to the PBS. Research into the reasons for their extensive use in elderly women is needed to inform more rational prescribing of these medicines.

In Australia, children removed from the parental home because substance use–related child maltreatment issues are commonly placed in grandparent custodial care; however, the longer term relational costs of this approach have yet to be determined. Conventional, summative, and directive content analyses were conducted on data extracted from 88 Australian custodial grandparent completed Grandcarer Needs, Wellbeing and Health Surveys. Conventional analysis revealed the most common reason grandparents gave for their assumption of custodial care was drug use–related acts of parental child maltreatment. Summative analysis revealed antidepressants, marijuana, Valium, ice, and amphetamines were the most commonly used parental drugs and that these drugs were frequently used in combination with dexamphetamine, antipsychotics, heroin, ecstasy, and cocaine. Directed analysis contextualized the strain that drug use–related custodial caregiving places on grandparents’ financial resources, and how this strain is burdensome when the grandparents’ annual income is less than Aus$80,000. It also contextualizes the need for future research to explore family reunification desires/barriers.

Since 1988 a number of public figures in Australia have argued that prohibitions on the use of cannabis, cocaine, and heroin should be relaxed because current drug policies do not reflect the comparative risks of licit and illicit drug use, and many of the social costs of illicit drug use are consequences of prohibition. They have advocated a variety of proposals for reforming drug policy. Proponents of “controlled availability” have proposed that currently illegal drugs should be provided under medical supervision to persons who are dependent on them. Critics concerned about the social costs of drug policies have advocated policies to undercut the black market by increasing the availability of currently illicit drugs. The mechanisms proposed for achieving this end have included de facto and de jure decriminalization of drug use, and the provision of currently illicit drugs to licensed adults by a government monopoly. Despite a vigorous debate, drug policies have not changed because reformers have failed to convince the public that their policies will not increase the use of illicit drugs, and hence the prevalence of drug dependence and drug-related problems.

Abstract Aims The Heart Outcomes Prevention Evaluation-3 (HOPE-3) found that rosuvastatin alone or with candesartan and hydrochlorothiazide (HCT) (in a subgroup with hypertension) significantly lowered cardiovascular events compared with placebo in 12 705 individuals from 21 countries at intermediate risk and without cardiovascular disease. We assessed the costs implications of implementation in primary prevention in countries at different economic levels. Methods and results Hospitalizations, procedures, study and non-study medications were documented. We applied country-specific costs to the healthcare resources consumed for each patient. We calculated the average cost per patient in US dollars for the duration of the study (5.6 years). Sensitivity analyses were also performed with cheapest equivalent substitutes. The combination of rosuvastatin with candesartan/HCT reduced total costs and was a cost-saving strategy in United States, Canada, Europe, and Australia. In contrast, the treatments were more expensive in developing countries even when cheapest equivalent substitutes were used. After adjustment for gross domestic product (GDP), the costs of cheapest equivalent substitutes in proportion to the health care costs were higher in developing countries in comparison to developed countries. Conclusion Rosuvastatin and candesartan/HCT in primary prevention is a cost-saving approach in developed countries, but not in developing countries as both drugs and their cheapest equivalent substitutes are relatively more expensive despite adjustment by GDP. Reductions in costs of these drugs in developing countries are essential to make statins and blood pressure lowering drugs affordable and ensure their use. Clinical trial registration HOPE-3 ClinicalTrials.gov number, NCT00468923.

Background:Rheumatoid arthritis (RA) carries a substantial burden for patients and society in terms of morbidity, enduring disability, and costs [1]. The Australian Pharmaceutical Benefits Scheme (PBS) has subsidised biological disease-modifying anti-rheumatic drugs (B-DMARDs) since 2003 [2].Objectives:We examined the impact of B-DMARDs availability on RA hospitalisation rate in the Western Australia (WA) population pre- and post- B-DMARDs introduction to the PBS (1995-2002 and 2003-2014).Methods:Population PBS dispensing data for WA of DMARD were obtained and converted to defined daily doses (DDD)/1000 population/day using the WA population census. RA inpatient records were extracted from the WA Hospital Morbidity Data Collection using ICD-9 codes 714 and ICD-10 codes M05.00–M06.99). Principal component analysis (PCA) was applied to determine the relationship between DMARDs use and RA hospital admission rates.Results:There was a total of 17,125 patients who had 50,353 admissions with a diagnostic code for RA during the study period. DMARD use for RA rose from 1.45 to 3.19 DDD/1000 population/day over 1995-2014 (Figure 1). In 1995-2002, the number of RA admissions fell from 7.9 to 2.6 per 1000 hospital separations, then dropped further from 2.9 to 1.9 per 1000 hospital separations in 2003-2014. Based on PCA analysis, conventional DMARDs (methotrexate) and B-DMARDs dispensing had an inverse association with hospital admissions for RA.Conclusion:The increased availability of conventional and biological DMARDs for RA was associated with a significant decline in hospital admissions for RA patients in WA.References:[1]Boonen A, Severens JL (2011) The burden of illness of rheumatoid arthritis. Clin Rheumatol 30:3-8.[2]Medicare Australia (2020) Pharmaceutical Benefits Schedule statistics. http://medicarestatistics.humanservices.gov.au/statistics/pbs_item.jsp.Figure 1.The hospital separations and total drugs use patterns of RA in 1995-2014 in Western Australia.Acknowledgements:Supported by an Australian Government Research Training Program PhD Scholarship at the University of Western Australia.Disclosure of Interests:Khalid Almutairi: None declared, Johannes Nossent Speakers bureau: Janssen, David Preen: None declared, Helen Keen Speakers bureau: Pfizer Australia, Abbvie Australia, Charles Inderjeeth Speakers bureau: bureau: Eli Lilly

Due to the considerable increase in public expenditure with health issues, mainly regarding drugs, several countries, including Australia and England, have already implemented, or are in the process of discussing the adoption of measures to ensure the quality of health care provided to the population. One of the less harmful strategies, rarely used in Brazil, is the adoption of economic techniques applied to health, more specifically, pharmacoeconomic analysis. This paper aims to contribute to the dissemination of concepts and techniques of economic analysis with a view to incorporate these into policy decisions of expenditure rationalization and the search for clinical efficiency. It includes a literature review covering the types of costs and benefits in health issues, the methodologies of pharmacoeconomic analysis, cost-minimization, cost-benefits, cost-effectiveness and cost-utility analysis, as well as its main characteristics, advantages, disadvantages and applicability.

ABSTRACTBackground: Alzheimer's drugs are believed to have limited availability and to be unaffordable in low- and middle-income countries compared to high-income countries. The price, availability and affordability of Alzheimer's drugs have not been reported before.Methods: During 2007 an international survey was conducted in 21 countries in six continents (Argentina, Australia, Brazil, the Dominican Republic, France, India, Japan, Macedonia, Mexico, New Zealand, Nigeria, the Philippines, Portugal, Serbia, South Korea, Switzerland, Taiwan, Thailand, Uganda, the U.K. and the U.S.A.). Prices of Alzheimer's drugs were compared using the affordability index (the total number of units purchasable with one's daily income) derived from purchasing power parity (PPP) converted prices as well as raw prices.Results: Donepezil is available in all 21 countries, whereas the newer drugs are less available. A 5 mg tablet of branded originator donepezil costs just US$0.26 in India and US$0.31 in Mexico, whereas it costs US$6.64 in the U.S.A. Pricing conditions of rivastigmine, galantamine and memantine appear to be similar to that of donepezil. The cheapest branded originators are from India and Mexico. However, in terms of PPP, Alzheimer's drugs in other low- and middle-income countries are much more expensive than in high-income countries. Most people in low- and middle-income countries cannot afford Alzheimer's drugs.Conclusions: Alzheimer's drugs, albeit available, are often unaffordable for those who need them most. It is hoped that equitable differential pricing will be applied to Alzheimer's drugs.

Government spending are the basic of the health economics of any developed countries. We are overwhelmingly confident that an increase in the financing of the health care system makes it possible to improve the population’s access to medical care, which, accordingly, it is reflected on an increasing quality of life and its duration. Undoubtedly, investments in the healthcare industry should lead to the creation of new jobs, the development and introduction of advanced medical technologies and innovative drugs into clinical practice. In recent years, in the Russian Federation, there has been a positive trend in the volume of funds allocated by the state to protect public health. The article is devoted to the study of possible factors causing this growth. The authors made an attempt to answer the questions whether the increase in health care costs is due only to the political will of decision makers at the federal level, whether unhealthy lifestyles of the country’s citizens affect health care costs, which primarily depend on the costs of health care resources and others. To answer these questions, the authors analyzed the behavior of individual indicators reflecting health care expenditures and population health indicators for the Russian Federation in comparison with the countries of the Organization for Economic Development and Cooperation (OECD) – Australia, Canada, Denmark, France, Germany, Japan, Netherlands, New Zealand, Norway, Sweden, Switzerland, the UK and the USA.

ObjectivesAssessing the cost-effectiveness credentials of this intervention in patients with concomitant atrial fibrillation (AF) and heart failure (HF) compared with usual medical therapy.DesignA Markov model comprising two health states (ie, alive or dead) was constructed. The transition probabilities were directly derived from published Kaplan-Meier curves of the pivotal randomised controlled trial and extrapolated over the cohort’s lifetime using recommended methods. Costs of catheter ablation, outpatient consultations, hospitalisation, medications and examinations were included. Resource use and unit costs were sourced from government websites or published literature. A lifetime horizon and a healthcare system perspective were taken. All costs and benefits were discounted at 3% annually. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were run around the key model parameters to test the robustness of the base case results.ParticipantsA hypothetical Australian cohort of patients with concomitant AF and HF who are resistant to antiarrhythmic treatment.InterventionsCatheter ablation versus medical therapy.ResultsThe catheter ablation was associated with a cost of $A44 377 per person, in comparison to $A28 506 for the medical therapy alone over a lifetime. Catheter ablation contributed to 4.58 quality-adjusted life years (QALYs) and 6.99 LY gains compared with 4.30 QALYs and 6.53 LY gains, respectively, in the medical therapy arm. The incremental cost-effectiveness ratio was $A55 942/QALY or $A35 020/LY. The DSA showed that results were highly sensitive to costs of ablation and time horizon. The PSA yielded very consistent results with the base case.ConclusionsOffering catheter ablation procedure to patients with systematic paroxysmal or persistent AF who failed to respond to antiarrhythmic drugs was associated with higher costs, greater benefits. When compared with medical therapy alone, this intervention is not cost-effective from an Australia healthcare system perspective.

The role of government in assuring population access to affordable and appropriate health care represents a central question for any nation. Of particular concern is access to prescription drug coverage, not only because of the vital role played by drugs in modern medicine, but also because of their high costs. This article examines the sharply contrasting prescription drug coverage and payment policies found in Australia and the U.S. – strong political allies and international trading partners – and describes how key U.S. interests have sought, through an aggressive trade agenda, to expand markets for U.S. goods and services, even when market expansions clash with other nations’ contrasting emphasis on social equity and fairness. Indeed, the nation’s bilateral free trade negotiations have brought the contours of this policy schism into sharp relief.

472 Background: Recently, immune-modulating drugs have been introduced to the second line setting of advanced bladder cancer. Pembrolizumab increases overall survival and is associated with less toxicity compared to chemotherapy in this setting based on the Keynote-045 study. The high cost of immunotherapy necessitates an assessment of its value by considering both efficacy and cost. The objective of this study is to estimate the cost-effectiveness of pembrolizumab for the second-line treatment of advanced bladder cancer from the perspective of payers in multiple countries. Methods: We developed a Markov model to compare the costs and effectiveness of pembrolizumab with those of chemotherapy in the second-line treatment of advanced bladder cancer. Health outcomes were measured in life-years (LYs) and quality-adjusted life-years (QALYs). Drug costs were acquired for the following countries: U.S., U.K., Canada and Australia. Model robustness was addressed in univariate and probabilistic sensitivity analyses. Results: Pembrolizumab generated a gain of 0.36 QALYs compared to chemotherapy. Our analysis established the following incremental cost-effectiveness ratios (ICERs) for pembrolizumab versus chemotherapy in second-line advanced bladder cancer treatment - U.S. $122,557/QALY, U.K. $91,995/QALY, Canada $93,648/QALY, and Australia $99,966/QALY. The willingness-to-pay (WTP) thresholds per QALY are considered to be around 100,000-150,000 US dollars for the U.S., 20,000-50,000 pounds for the U.K. [25,000-65,000 US $], 20,000-100,000 CAD for Canada [16,000-80,000 US $] and 40,000-75,000 AUD for Australia [32,000-60,000 US $]. Conclusions: Cost-effectiveness and WTP thresholds vary between countries. Compared to the other countries examined, U.S. drug prices were found to be highest, leading to the highest ICER. With standard willingness-to-pay thresholds, pembrolizumab may be considered cost-effective in the U.S., but not in the other countries examined.

In many countries, health technology assessment (HTA) organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in (1) the methodologies HTA organizations use to conduct their evaluations and (2) considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy.

Background. Advantages of the ex tempore formulation include the ability to provide the drug in the form and dosage, not available on the pharmaceutical market, but necessary for a particular patient; the ability to include the required ingredient in any desired form; the option of combining drugs; the manufacture of drugs without flavorings, preservatives and stabilizers; the possibility of adjusting of the drug taste; the possibility of manufacturing drugs that are in short supply on the market; no possibility of counterfeiting; production of specific drugs. Objective. Assess the current situation and trends in the preparation of oncological drugs ex tempore. Materials and methods. Analysis of the literature on this topic. Results and discussion. In oncology the possibilities of ex tempore preparation include the manufacture of chemotherapeutic agents with individual dosage, of any adjuvant agents without excipients, of radiopharmaceuticals, combined and orphan drugs. In Ukraine, ex tempore formulation is not widespread: as of 2017, the percentage of drugs prepared in such way was 1.7 %, in 2018 – 1.43 %, in 2019 – 1.41 %. The situation is different in the European Union. For instance, in Poland the pharmacy receives a license only after creating the conditions for the manufacture of drugs, in Estonia any pharmacy must be able to produce non-sterile drugs, in Latvia 50 % of pharmacies have a license to manufacture drugs. The popularity of ex tempore preparation is also growing in the other countries (Australia, USA, Brazil, Jordan). The main areas of application of ex tempore drugs include hormone replacement therapy, analgesia, dermatology, chemotherapy, ophthalmology, treatment of orphan diseases, parenteral nutrition. Civilized countries often choose to develop the hospital pharmacy. However, there are a number of problems, including the lack of well-trained staff, the high cost of equipment and maintenance of sterile facilities, the constant changes in regulatory requirements and the need to gain the consumers’ respect. Conclusions. 1. Ex tempore drug preparation has a number of advantages, in particular, the ability to provide the drug in the individual form and dosage, the ability to combine drugs and the manufacture of specific drugs. 2. Extemporaneous preparation of drugs is especially important for oncology. 3. In contrast to European Union countries, ex tempore drug preparation is not widespread in Ukraine. 4. Problems of ex tempore drug preparation include lack of the staff, high equipment costs, and constant changes in regulatory requirements.

Rhinovirus-(RV-) induced asthma exacerbations account for high asthma-related health costs and morbidity in Australia. The cellular mechanism underlying this pathology is likely the result of RV-induced nuclear-factor-kappa-B-(NF-κB-) dependent inflammation. NF-κB may also be important in RV replication as inhibition of NF-κB inhibits replication of other viruses such as human immunodeficiency virus and cytomegalovirus. To establish the role of NF-κB inhibitors in RV-induced IL- 6 and IL-8 and RV replication, we used pharmacological inhibitors of NF-κB, and steroids and/or β2 agonists were used for comparison. Primary human lung fibroblasts were infected with RV-16 in the presence of NF-κB inhibitors: BAY-117085 and dimethyl fumarate; β2 agonist: salmeterol; and/or corticosteroids: dexamethasone; fluticasone. RV-induced IL-6 and IL-8 and RV replication were assessed using ELISAs and virus titration assays. RV replicated and increased IL-6 and IL-8 release. Salmeterol increased, while dexamethasone and fluticasone decreased RV-induced IL-6 and IL-8 (P<0.05). The NF-κB inhibitor BAY-117085 inhibited only RV-induced IL-6 (P<0.05) and dimethyl fumarate did not alter RV-induced IL-6 and IL-8. Dimethylfumarate increased RV replication whilst other drugs did not alter RV replication. These data suggest that inhibition of NF-κB alone is unlikely to be an effective treatment compared to current asthma therapeutics.

Hospitalised patients commonly experience adverse drug events (ADEs) and medication errors. Runciman reported that ADEs in hospitals account for 20% of reported adverse events and contribute to 27% of deaths where death followed an adverse event. Hughes recommends multidisciplinary hospital drug committees to assess performance and raise standards. The new Code of Conduct of the Medical Board of Australia recommends participation in systems for surveillance and monitoring of adverse events, and to improve patient safety. We describe the functions and role of a Drug Safety Working Group (DSWG) in a suburban hospital, which aims to audit and promote a culture of prescribing and medication administration that is prudent and cautious to minimise the risk of harm to patients. We believe that regular prescription monitoring and feedback to Resident Medical Officers (RMOs) improves medication management in our hospital. What is known about the topic? Adverse drug events are common, leading to increased patient dissatisfaction, increased hospital morbidity and mortality, and increased costs. There is extensive medical literature on the problems of individual drugs, and global information of ADEs in healthcare, but little information for local solutions. What does this paper add? This paper details our experience and methods of running a drug safety working group (DSWG) in a suburban hospital. We strongly believe in a multidisciplinary committee, with feedback to RMOs given by their peer group. This ‘how we do it’ approach is largely absent from medical journals. What are the implications for practitioners? We strive for safer prescribing in our environment and hope to develop for inter-hospital benchmarking with other hospital DSWGs of clearly similar data, with an aim to raise state or nationwide standards.

Background. Real clinical practice (RCP) exists in an evidence-based and regulatory framework, taking into account the social, political and economic situation in the country. Coronavirus pandemic (COVID-19) is the main challenge of modern RCP. Objective. To describe the modern features of the RCP. Materials and methods. Analysis of literature sources on this issue. Results and discussion. On December 31, 2019, WHO was informed about 27 cases of pneumonia of unknown origin. On January 1, 2020, the first WHO guidelines were issued. The COVID-19 outbreak was declared a health emergency on January 30 and a pandemic – on March 11. Experience with COVID-19 varies from country to country. In Germany, for example, pharmacies were allowed to produce disinfectants on their own, in Australia the telemedicine system was expanded, and in Poland a law was issued that provided the regulation of remote work, simplification of public procurement, and emergency pharmacy prescriptions. In Ukraine, the first information from the Ministry of Health on coronavirus was published on January 21. On February 19, a decision was made to procure medicines to combat COVID-19. On March 11, the export of personal protective equipment was banned, and on March 12, quarantine was imposed throughout Ukraine. On March 17, the first laws of Ukraine on combating the coronavirus were adopted. One in four patients who fell ill at the beginning of the outbreak was a health worker, which reduced the availability of medical care. The imposition of a pandemic on phase 2 of health care reform has limited health care and patients’ access to clinics and hospitals, and suspended planned hospitalizations and surgeries. Medicines without evidence were included in the COVID-19 National Treatment Protocol. An analysis of drug sales in pharmacies showed that quarantine had decreased the sales of cough and cold remedies, nasal irrigation solutions (due to a reduction in the number of socially transmitted diseases), and antidiarrheal drugs. Instead, sales of laxatives have increased (presumably due to changes in diet and limited physical activity). Sales of drugs for the treatment of sexually transmitted diseases also decreased. Quarantine in combination with the restriction of the availability of infusion therapy in the practice of the family doctor has led to a reduction in the appointment of parenteral drugs by half. In the absence of planned hospitalizations and surgeries, the volume of prescriptions for infusion drugs decreased by 13 %. There was a redistribution of drug consumption in favor of domestic drugs. “Yuria-Pharm” was in the top 3 among Ukrainian drug manufacturers. 6 out of 10 general leaders are domestic companies. “Yuria-Pharm” is a leader in blood substitutes and perfusion solutions prescribed by doctors of 16 specialties. The solutions were most often prescribed for pneumonia, mental and behavioral disorders caused by alcohol abuse, acute pancreatitis, cerebrovascular diseases, delivery, acute appendicitis, malignant tumors, insulin-dependent diabetes mellitus, chronic ischemic heart disease. For example, Tivortin (“Yuria-Pharm”) is most often prescribed by gynecologists, less often – by physicians / family doctors, neurologists, surgeons, cardiologists, anesthesiologists. In turn, Reosorbilact (“Yuria-Pharm”) is among the top 3 drugs administered by hospital doctors for the period 2014-2020. Repeated prescriptions for reimbursement were issued remotely, however, despite government programs, treatment in Ukraine still depends on the patient’s money. The National Health Service of Ukraine for 2021 proposed to increase the salaries of health care workers and reduce the catastrophic costs of medicines paid by patient on its own. At present, there is a need to transfer the results of clinical trials to the RCP, as the studies are conducted in specialized strictly controlled conditions, and the RCP allows to obtain more real results. There are several types of RCP studies: non-interventional, post-registration, marketing, pharmacoeconomic, and patient database and registry studies. Conclusions. 1. COVID-19 pandemic is the main challenge of modern RCP. 2. The imposition of a pandemic onto phase 2 of health care reform has limited health care and patients’ access to clinics and hospitals, and suspended planned hospitalizations and surgeries. 3. In the conditions of pandemic and quarantine there was a redistribution of drug consumption in favor of domestic drugs. 4. Reosorbilact (“Yuria-Pharm”) is among the top 3 drugs administered by hospital doctors for the period 2014-2020.

Background Anxiety, mood, and substance use disorders have significant social and economic impacts, which are largely attributable to their early age of onset and chronic disabling course. Therefore, it is critical to intervene early to prevent chronic and debilitating trajectories. Objective This paper describes the study protocol of a CONSORT (Consolidated Standards of Reporting Trials)-compliant randomized controlled trial for evaluating the effectiveness of the Mind your Mate program, a mobile health (mHealth) peer intervention that aims to prevent mental health (focusing on anxiety and depression) and substance use problems in adolescents. Methods Participants will consist of approximately 840 year 9 or year 10 students (60 students per grade per school) from 14 New South Wales high schools in Sydney, Australia. Schools will be recruited from a random selection of independent and public schools across the New South Wales Greater Sydney Area by using publicly available contact details. The intervention will consist of 1 introductory classroom lesson and a downloadable mobile app that will be available for use for 12 months. Schools will be randomly allocated to receive either the mHealth peer intervention or a waitlist control (health education as usual). All students will be given web-based self-assessments at baseline and at 6- and 12-month follow-ups. The primary outcomes of the trial will be the self-reported use of alcohol and drugs, anxiety and depression symptoms, knowledge about mental health and substance use, motives for not drinking, and willingness to seek help. Secondary outcomes will include positive well-being, the quality of life, and the impact of the COVID-19 pandemic. Analyses will be conducted using mixed-effects linear regression analyses for normally distributed data and mixed-effects logistic regression analyses for categorical data. Results The Mind your Mate study was funded by an Australian Rotary Health Bruce Edwards Postdoctoral Research Fellowship from 2019 to 2022. Some of the development costs for the Mind your Mate intervention came from a seed funding grant from the Brain and Mind Centre of the University of Sydney. The enrollment of schools began in July 2020; 12 of 14 schools were enrolled at the time of submission. Baseline assessments are currently underway, and the first results are expected to be submitted for publication in 2022. Conclusions The Mind your Mate study will generate vital new knowledge about the effectiveness of a peer support prevention strategy in real-world settings for the most common mental disorders in youth. If effective, this intervention will constitute a scalable, low-cost prevention strategy that has significant potential to reduce the impact of mental and substance use disorders. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12620000753954; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379738&isReview=true International Registered Report Identifier (IRRID) DERR1-10.2196/26796

Background There is limited evidence of the impact of needle and syringe programmes (NSPs) and opioid substitution therapy (OST) on hepatitis C virus (HCV) incidence among people who inject drugs (PWID), nor have there been any economic evaluations. Objective(s) To measure (1) the impact of NSP and OST, (2) changes in the extent of provision of both interventions, and (3) costs and cost-effectiveness of NSPs on HCV infection transmission. Design We conducted (1) a systematic review; (2) an analysis of existing data sets, including collating costs of NSPs; and (3) a dynamic deterministic model to estimate the impact of differing OST/NSP intervention coverage levels for reducing HCV infection prevalence, incidence and disease burden, and incremental cost-effectiveness ratios to measure the cost-effectiveness of current NSP provision versus no provision. Setting Cost-effectiveness analysis and impact modelling in three UK sites. The pooled analysis drew on data from the UK and Australia. The review was international. Participants PWID. Interventions NSP coverage (proportion of injections covered by clean needles) and OST. Outcome New cases of HCV infection. Results The review suggested that OST reduced the risk of HCV infection acquisition by 50% [rate ratio (RR) 0.50, 95% confidence interval (CI) 0.40 to 0.63]. Weaker evidence was found in areas of high (≥ 100%) NSP coverage (RR 0.77, 95% CI 0.38 to 1.54) internationally. There was moderate evidence for combined high coverage of NSPs and OST (RR 0.29, 95% CI 0.13 to 0.65). The pooled analysis showed that combined high coverage of NSPs and OST reduced the risk of HCV infection acquisition by 29–71% compared with those on minimal harm reduction (no OST, ≤ 100% NSP coverage). NSPs are likely to be cost-effective and are cost-saving in some settings. The impact modelling suggest that removing OST (current coverage 81%) and NSPs (coverage 54%) in one site would increase HCV infection incidence by 329% [95% credible interval (CrI) 110% to 953%] in 2031 and at least double (132% increase; 95% CrI 51% to 306%) the number of new infections over 15 years. Increasing NSP coverage to 80% has the largest impact in the site with the lowest current NSP coverage (35%), resulting in a 27% (95% CrI 7% to 43%) decrease in new infections and 41% (95% CrI 11% to 72%) decrease in incidence by 2031 compared with 2016. Addressing homelessness and reducing the harm associated with the injection of crack cocaine could avert approximately 60% of HCV infections over the next 15 years. Limitations Findings are limited by the misclassification of NSP coverage and the simplified intervention definition that fails to capture the integrated services that address other social and health needs as part of this. Conclusions There is moderate evidence of the effectiveness of OST and NSPs, especially in combination, on HCV infection acquisition risk. Policies to ensure that NSPs can be accessed alongside OST are needed. NSPs are cost-saving in some sites and cost-effective in others. NSPs and OST are likely to prevent considerable rates of HCV infection in the UK. Increasing NSP coverage will have most impact in settings with low coverage. Scaling up other interventions such as HCV infection treatment are needed to decrease epidemics to low levels in higher prevalence settings. Future work To understand the mechanisms through which NSPs and OST achieve their effect and the optimum contexts to support implementation. Funding The National Institute for Health Research Public Health Research programme.

Physicians in the United States have been affected by significant changes in the pattern(s) of medical practice evolving over the last several decades. These changes include new measures to 1) curb increasing costs, 2) increase access to patient care, 3) improve quality of healthcare, and 4) pay for prescription drugs. Escalating healthcare costs have focused concerns about the financial solvency of Medicare and this in turn has fostered a renewed interest in the economic basis of interventional pain management practices. The provision and systemization of healthcare in North America and several European countries are difficult enterprises to manage irrespective of whether these provisions and systems are privatized (as in the United States) or nationalized or semi-nationalized (as in Great Britain, Canada, Australia and France). Consequently, while many management options have been put forth, none seem to be optimally geared toward affording healthcare as a maximized individual and social good, and none have been completely enacted. The current physician fee schedule (released on July 12, 2007) includes a 9.9% cut in payment rate. Since the Medicare program was created in 1965, several methods have been used to determine physicians’ rate(s) for each covered service. The sustained growth rate (SGR) system, established in 1998, has evoked negative consequences on physician payment(s). Based on the current Medicare expenditure index, practice expenses are projected to increase by 34.5% from 2002 to 2016, whereas, if actual practice inflation is considered, this increase will be 90%. This is in contrast to projected physician payment cuts that are depicted to be 51%. No doubt, this scenario will be devastating to many practices and the US medical community at large. Resolutions to this problem have been offered by MedPAC, the Government Accountability Office, physician organizations, economists, and various other interested groups. In the past, temporary measures have been proposed (and sometimes implemented) to eliminate physician payment cuts. At present, the US Senate and House of Representatives are separately working on 2 different mechanisms to address and rectify these cost-payment discrepancies. The effects of both the problem and the potential solutions on interventional pain management may be somewhat greater than those on other specialties. Physician payments in interventional pain management may evidence cuts of 10% to 15%, whereas if procedures are performed in an office setting, such cuts may range from 29% to 39% over the period of the next 3 years if the proposed 9.9% cut is not reversed. Medicare cuts also impact other insurance payments, incurring a “ripple effect” such that many insurers will seek to pay at or around the Medicare rate. In this manuscript, we discuss universal healthcare systems, the CMS proposed ruling and its attendant ripple effect(s), historical aspects of the Medicare payment system, the Sustained Growth Rate system, and the potential consequences incurred by both proposed cuts and potential solutions to the discrepant cost-payment issue(s). As well, ethical issues of policy development upon the infrastructure and practice of interventional pain management are addressed. Key words: Health policy, physician payment policy, physician fee schedule, Medicare, sustained growth rate formula, interventional pain management, regulatory reform, ethics

The World Health Organization (WHO) has placed N. gonorrhoeae on the global priority list of antimicrobial resistant pathogens and is urgently seeking the development of new intervention strategies. N. gonorrhoeae causes 86.9 million cases globally per annum. The effects of gonococcal disease are seen predominantly in women and children and especially in the Australian Indigenous community. While economic modelling suggests that this infection alone may directly cost the USA health care system USD 11.0–20.6 billion, indirect costs associated with adverse disease and pregnancy outcomes, disease prevention, and productivity loss, mean that the overall effect of the disease is far greater still. In this review, we summate the current progress towards the development of a gonorrhea vaccine and describe the clinical trials being undertaken in Australia to assess the efficacy of the current formulation of Bexsero® in controlling disease.

ECONOMIC AND SOCIAL COSTS OF GAMBLING ADDICTION IN CROATIA – THE OTHER SIDE OF THE MEDAL ABSTRACT Gambling, as a behavior primarily aimed at entertainment and leisure, is risky due to the potential development of harmful psychosocial consequences, i.e. the development of gambling addiction symptoms. These include the full range of health (physical and mental), social (family, friends, community), and economic (employment, finances, and crime) adverse consequences. The aim of this research is to calculate the economic and social costs of gambling addiction in the Republic of Croatia in order to provide science-based indicators to encourage positive regulatory changes that would ensure a balanced market between profitable and risky elements of the gambling industry. The research starts from the scientific research on the prevalence of gambling addiction in the adult Croatian population and the official data on revenues in the state budget from all gambling activities. Two of the most commonly used methodologies were used to calculate the social and economic costs: National Opinion Research Centre − NORC and Australian Productivity Commission − APC. The research uses original and strict criteria for the prevalence of gambling addiction. Regardless of the methodology used, the results show that the social costs of gambling addiction in Croatia account for between 34% and 77% of the total annual gambling revenue. Ljetopis socijalnog rada 2021., 28 (1), 37-70. 70 članci The results were interpreted in the context of general guidelines for improving the policy of responsible gambling, with the aim of reducing the likelihood of developing harmful psychosocial consequences in society. Key words: gambling; gambling addiction; economic costs; social costs; consequences

This paper uses NATSEM's Pharmaceutical Benefits Model to analyse the effects of a hypothetical25 per cent rise in patient contributions to prescribed medicines under Australia's PharmaceuticalBenefits Scheme (PBS). The model, based on microsimulation techniques, is able to provide a muchbroader range of outcomes information, at a much greater level of detail, than is possible withtraditional methods.Higher patient contributions are analysed in terms of their impact on the government to patient splitin PBS costs, as well as the distribution of such costs across age groups, family incomes, family types and36 prescribed medicine types. Also considered are changes in the shares of family disposable incomesspent on prescribed drugs arising from the higher patient contributions.

ObjectivesWe aimed to estimate the annual pharmaceutical costs for patients with stable coronary artery disease, using Australian administrative data, comparing patients who had undergone interventional treatment with those had not. We also aimed to compare the duration of dual antiplatelet therapy (DAPT) prescription in the real-world, with recommended guidelines.DesignAn observational study using administrative data.ParticipantsWe used data from the QSkin study, a population-based prospective study assessing skin cancer risk. Participants were invited from the Queensland population, not based on perceived skin cancer risk, and had consented to future use of their data for approved research projects.Main outcome measuresWe calculated 12-month costs of pharmaceutical therapy for coronary artery disease for patients in each of three clinically relevant groups: medical therapy only, following coronary stent implantation and following coronary artery bypass graft surgery. We measured the duration of DAPT following stent implantation and total duration of DAPT, where it was prescribed, in the medical therapy only group.ResultsEstimated mean annual pharmaceutical costs were highest in the stent group at AUD$1920, compared with AUD$1481 in the medical therapy group, and AUD$881 in the coronary artery bypass group. There were similar rates of prescriptions of symptom relief drugs following stent insertion, compared with the medical therapy only group. The median duration of DAPT in the stent group was 16, and 31 months in the medical therapy group.ConclusionsOur results suggest that despite the common expectation that the burden of medical therapy is reduced following coronary stent insertion for stable coronary artery disease, this does not occur in practice. Many patients also appear to continue DAPT longer than guidelines recommend, which may put them at unnecessarily elevated risk of bleeding events.

Programs and policies are increasingly framed by the logics of “evidence-based policy,” a term subject to critical scrutiny and change after it emerged as an explicit valuing of specific types of quantitative data as objective, and a devaluing of most types of qualitative data. The transfer of “evidence-based” approaches to drug policy was mobilized by a distrust of people who use drugs, and of people who work with them. This distrust remains important, but contemporary policy also mobilizes individual narratives and lived experience through the growing use of biographical stories. Contemporary drug policy, like other policy areas, is also increasingly constituted by changing forms of technology, through new types of data use and data linkage, and of digital and social media. In this article, we consider the current and likely future impacts of changes to policy. We examine two Australian policies: the Australian Priority Investment Approach to Welfare (Try, Test and Learn), and the child protection reform, Their Futures Matter. Both use the “investment approach” to calculate policy costs and aims, represent important developments in the policy figuring of populations, and affect the well-being of many people who use drugs. Based on analysis of these policies, and interviews with people who use drugs who participated in a qualitative study on blood-borne virus serodiscordance, we ask, what are the likely effects, risks, and benefits of these changes for people who use drugs and others subject to public scrutiny and distrust? We argue that as long as the stigmatization of drug use remains prevalent, it is unlikely that the potential for more sophisticated and just recognition of the complexity of drug use will find a place in the forms of information and knowledge recognized in policy as evidence.

AbstractBackground. The aim of the study was to estimate the direct medical costs of metastatic colorectal cancer (mCRC) treated at the Institute of Oncology Ljubljana and to question the healthcare payment system in Slovenia.Methods. Using an internal patient database, the costs of mCRC patients were estimated in 2009 by examining (1) mCRC direct medical related costs, and (2) the cost difference between payment received by Slovenian health insurance and actual mCRC costs. Costs were analysed in the treatment phase of the disease by assessing the direct medical costs of hospital treatment with systemic therapy together with hospital treatment of side effects, without assessing radiotherapy or surgical treatment. Follow-up costs, indirect medical costs, and nonmedical costs were not included.Results. A total of 209 mCRC patients met all eligibility criteria. The direct medical costs of mCRC hospitalization with systemic therapy in Slovenia for 2009 were estimated as the cost of medications (cost of systemic therapy + cost of drugs for premedication) + labor cost (the cost of carrying out systemic treatment) + cost of lab tests + cost of imaging tests + KRAS testing cost + cost of hospital treatment due to side effects of mCRC treatment, and amounted to €3,914,697. The difference between the cost paid by health insurance and actual costs, estimated as direct medical costs of hospitalization of mCRC patients treated with systemic therapy at the Institute of Oncology Ljubljana in 2009, was €1,900,757.80.Conclusions. The costs paid to the Institute of Oncology Ljubljana by health insurance for treating mCRC with systemic therapy do not match the actual cost of treatment. In fact, the difference between the payment and the actual cost estimated as direct medical costs of hospitalization of mCRC patients treated with systemic therapy at the Institute of Oncology Ljubljana in 2009 was €1,900,757.80. The model Australian Refined Diagnosis Related Groups (AR-DRG) for cost assessment in oncology being currently used is probably one of the reasons for the discrepancy between pay-outs and actual costs. We propose new method for more precise cost assessment in oncology.

Patients obtaining a prescription from a pharmacy expect that the drug will be effective and have minimal side-effects. Unfortunately, drugs exhibit the desired effect in ~25–60% of people prescribed any medication. Adverse effects occur at a rate of 10% in patients taking a medication, and this rate increases during and after hospitalisation, with the transition of care back to the ambulatory setting posing a particular risk. Pharmacogenomics testing has been shown to optimise pharmacotherapy by increasing medication effectiveness and reducing drug-related toxicity, thus curtailing overall healthcare costs. Evidence from international studies have shown that community pharmacists would be able to offer this highly relevant professional service to their clients, given suitable training. This specific training complements pharmacists’ existing skills and expertise by educating them in an emerging scientific area of pharmacogenomics. However, in an increasingly tight financial climate, the provision of pharmacogenomics testing by Australian community pharmacists will only be viable with an appropriate reimbursement through the Medicare Benefits Schedule, currently accessible by other allied health practitioners but not by pharmacists.

AbstractThe inclusion of both monetary and non-monetary indirect benefits in economic evaluations of public health programmes and services can have significant distributive effects between patient groups. As a result, some patients may be advantaged and others disadvantaged for reasons not directly related to health outcomes or (direct) treatment costs. In pluralistic democracies, there is a case for consulting the community on the fairness of policies that have such distributive implications. This paper reports the results of two pilot studies aimed at uncovering the preferences of the Australian public for the inclusion of indirect benefits in the evaluation of services for its national health scheme, Medicare. The initial survey found some support for taking account of non-monetary indirect benefits – for example, the social contribution made by parents of young children and carers of elderly relatives. By contrast, there was little support for giving high taxpayers priority access to general Medicare services, to life-saving organ transplants, or to very costly drugs, despite the indirect social benefits of doing so. However, such support increased significantly in the follow-up study when the outcomes were characterised as certain, identifiable and health related, and the opportunity costs of failing to take account of indirect benefits were made very clear. The follow-up survey provided evidence of public scepticism about the willingness or ability of government to use additional tax receipts for socially beneficial purposes, and/or a preference for programmes and services that focus on health rather than welfare more generally.

Introduction Serious bacterial neonatal infections are a major cause of global neonatal mortality. While hospitalized treatment is recommended, families cannot access inpatient treatment in low resource settings. Two parallel randomized control trials were conducted at five sites in three countries (Democratic Republic of Congo, Kenya, and Nigeria) to compare the effectiveness of treatment with experimental regimens requiring fewer injections with a reference regimen A (injection gentamicin plus injection procaine penicillin both once daily for 7 days) on the outpatient basis provided to young infants (0–59 days) with signs of possible serious bacterial infection (PSBI) when the referral was not feasible. Costs were estimated to quantify the financial implications of scaleup, and cost-effectiveness of these regimens. Methods Direct economic costs (including personnel, drugs and consumable costs) were estimated for identification, prenatal and postnatal visits, assessment, classification, treatment and follow-up. Data on time spent by providers on each activity was collected from 83% of providers. Indirect marginal financial costs were estimated for non-consumables/capital, training, transport, communication, administration and supervision by considering only a share of the total research and health system costs considered important for the program. Total economic costs (direct plus indirect) per young infant treated were estimated based on 39% of young infants enrolled in the trial during 2012 and the number of days each treated during one year. The incremental cost-effectiveness ratio was calculated using treatment failure after one week as the outcome indicator. Experimental regimens were compared to the reference regimen and pairwise comparisons were also made. Results The average costs of treating a young infant with clinical severe infection (a sub-category of PSBI) in 2012 was lowest with regimen D (injection gentamicin once daily for 2 days plus oral amoxicillin twice daily for 7 days) at US$ 20.9 (95% CI US$ 16.4–25.3) or US$ 32.5 (2018 prices). While all experimental regimens B (injection gentamicin once daily plus oral amoxicillin twice daily, both for 7 days), regimen C (once daily of injection gentamicin injection plus injection procaine penicillin for 2 days, thereafter oral amoxicillin twice daily for 5 days) and regimen D were found to be more cost-effective as compared with the reference regimen A; pairwise comparison showed regimen D was more cost-effective than B or C. For fast breathing, the average cost of treatment with regimen E (oral amoxicillin twice daily for 7 days) at US$ 18.3 (95% CI US$ 13.4–23.3) or US$ 29.0 (2018 prices) was more cost-effective than regimen A. Indirect costs were 32% of the total treatment costs. Conclusion Scaling up of outpatient treatment for PSBI when the referral is not feasible with fewer injections and oral antibiotics is cost-effective for young infants and can lead to increased access to treatment resulting in potential reductions in neonatal mortality. Clinical trial registration The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.

Objective: Antidepressant drugs and cognitive–behavioural therapy (CBT) are effective treatment options for depression and are recommended by clinical practice guidelines. As part of the Assessing Cost-effectiveness – Mental Health project we evaluate the available evidence on costs and benefits of CBT and drugs in the episodic and maintenance treatment of major depression. Method: The cost-effectiveness is modelled from a health-care perspective as the cost per disability-adjusted life year. Interventions are targeted at people with major depression who currently seek care but receive non-evidence based treatment. Uncertainty in model inputs is tested using Monte Carlo simulation methods. Results: All interventions for major depression examined have a favourable incremental cost-effectiveness ratio under Australian health service conditions. Bibliotherapy, group CBT, individual CBT by a psychologist on a public salary and tricyclic antidepressants (TCAs) are very cost-effective treatment options falling below $A10 000 per disability-adjusted life year (DALY) even when taking the upper limit of the uncertainty interval into account. Maintenance treatment with selective serotonin re-uptake inhibitors (SSRIs) is the most expensive option (ranging from $A17 000 to $A20 000 per DALY) but still well below $A50 000, which is considered the affordable threshold. Conclusions: A range of cost-effective interventions for episodes of major depression exists and is currently underutilized. Maintenance treatment strategies are required to significantly reduce the burden of depression, but the cost of long-term drug treatment for the large number of depressed people is high if SSRIs are the drug of choice. Key policy issues with regard to expanded provision of CBT concern the availability of suitably trained providers and the funding mechanisms for therapy in primary care.

Background. To save costs, the Australian Government recently deferred approval of seven new medicines recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for up to 7 months. Objectives. The aim of this research is to examine the timelines of PBAC applications following approval by the Therapeutic Goods Administration (TGA), allowing the recent Cabinet delays to be considered in the context of the overall medicines approval process. Methods. All new chemical entities and products for new indications approved in 2004 by the Australian Drug Evaluation Committee (ADEC) were identified. Outcomes of PBAC meetings from 2004 to 2010 were then searched to identify if and when these products were reviewed by PBAC. Results. ADEC recommended 63 eligible products for registration in 2004. Of the 113 submissions made to PBAC for these products, 66 were successful. Only 43% of the products were submitted to PBAC within 2 years, with an average 17-month delay from TGA approval of a product to consideration by the PBAC. Conclusions. Cabinet decisions to defer listing of new medicines delays access to new treatments. This occurred in addition to other longer delays, earlier in the approval process for medicines, resulting in a significant impact on the overall timeliness of listing. What is known about the topic? There is evidence that the time from registration of new drugs on the TGA to their listing for subsidised availability is increasing. The government’s recent decision to delay the listing of seven new drugs for subsidisation raised concerns about the potential for additional delays to impact the accessibility of new, affordable medicines for patients. What does this paper add? This paper examines delays at various stages in the process of approval for pharmaceutical subsidies on the Pharmaceutical Benefits Scheme (PBS), putting the deferral of new medicine listings in the overall context of the approval process. It identifies the potential role of pharmaceutical companies and product sponsors in delaying access to new, affordable medicines early in the approval process. What are the implications for practitioners? Delays in the subsidisation of medicines, wherever they occur in the process, not only reduce patient access, but may also lead to pressure in other areas of the health care system to finance such medicines. This makes these results of particular interest to clinician managers, health care managers and policy makers.

Introduction: Current guidelines recommend low-molecular-weight heparins (LMWH) over Vitamin K Antagonists (VKA) or Non-Vitamin K Antagonist Oral Anticoagulants (NOAC) for the treatment of cancer-associated venous thromboembolism (CAT), but also highlight that ultimately the choice of anticoagulant depends on patient-specific factors such as patient preferences, which is important for the acceptance of the treatment and, thus, for adherence and persistence. So far, little is known about the specific preferences of patients with CAT with respect to anticoagulation therapy. More specifically, the impact of dosing regimen, convenience and costs on patient preferences in CAT is poorly understood. Therefore, the objective of this discrete choice experiment (DCE) was to elucidate patient preferences regarding anticoagulation convenience attributes. Methods: Adult patients with active cancer who experienced a CAT event and for whom the decision was made to start a treatment with rivaroxaban after being treated with the standard of care anticoagulation (LMWH/VKA) for at least four weeks were included in a multinational, observational, single-arm study (COSIMO). As part of this study, a DCE was presented to the participants, who were asked to decide between complete hypothetical treatment options based on a combination of different attributes, regardless of efficacy or safety. The following attributes were preselected in a face-to-face discussion with three focus patients and in-depth interviews with four additional patients: route of administration (injection / tablet),frequency of intake (once / twice daily),need of regular controls of the International Normalized Ratio (INR) at least every 3-4 weeks (yes/no),interactions with food/alcohol (yes/no). Additionally, distance to treating physician (1 km vs. 20 km) was included as neutral comparator to express patients' overall utility in terms of a comprehensible unit. The relative importance of treatment attributes in terms of distances were calculated based on ratios between the utility estimates for each attribute. A fractional factorial design was generated resulting in nine hypothetical choice sets, supplemented by a test choice set to assess the consistency of a patient's responses. DCE data was collected by semi-structured telephone interviews, performed between week 4 and week 12 after enrollment of patients in the study and start of rivaroxaban. For each patient participating in the DCE interview, a written informed consent was obtained. Patient preferences were analyzed based on a conditional logit regression model. Results: Overall, 163 patients were included (Europe: 119; Canada: 41; Australia: 3), mean age 63.7 years, 49.1% were females and diagnosed with cancer for on average 22.4 months. Most patients in the COSIMO study changed to rivaroxaban from LMWH (> 95.0 %). The median time from diagnosis of index CAT event to conduct of DCE was 150 days (IQR 88-229). Patients strongly preferred oral administration compared to self-injections and drugs that can be taken irrespective of type of food or alcohol consumption (Figure 1). Furthermore, patients indicated slight preference for a shorter distance to the treating physician and a once daily dosing regimen compared to a twice-daily intake. The attribute "INR controls" showed no significant impact on the treatment decision. In order of patients' preference for their choice of treatment, the route of administration was by far the most important attribute for a patient's choice (73.8% of the overall decision), followed by food interactions (11.8%), the distance to treating physician (7.2%) and the intake frequency (6.5%). Accordingly, the expected utility of patients receiving an oral anticoagulation can be expressed as willingness to travel an additional distance of 192 km to the treating physician in order to avoid an injection. Conclusions Treatment related decision-making of patients with CAT, assuming equal effectiveness and safety of treatments, is predominantly driven by "route of administration", indicating a strong preference for oral intake. Disclosures Picker: Ingress-Health: Employment. Cohen:Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; ACI Clinical: Consultancy; GLG: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL Behring: Consultancy; Boston Scientific: Consultancy; AbbVie: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Aspen: Consultancy, Speakers Bureau; Guidepoint Global: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Medscape: Consultancy, Speakers Bureau; McKinsey: Consultancy; Navigant: Consultancy; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Consultancy; Temasek Capital: Consultancy; TRN: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism. Maraveyas:Bayer AG: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria; Pfizer: Honoraria. Beyer-Westendorf:Pfizer: Honoraria, Research Funding; Bayer HealthCare: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Research Funding. Lee:Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria; LEO Pharma: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria. Mantovani:Fondazione Charta: Consultancy; Bayer AG: Honoraria; Boehringer Ingelheim: Honoraria, Research Funding; Pfizer: Honoraria; Daiichi Sankyo: Research Funding. De Sanctis:Bayer US LLC: Employment, Equity Ownership. Abdelgawwad:Bayer AG: Employment. Fatoba:Bayer AG: Employment. Bach:Bayer AG: Employment. Wilke:Astra Zeneca: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Novo Nordisk: Consultancy, Honoraria; Pharmerit: Consultancy, Honoraria; Bayer AG: Consultancy, Honoraria; LEO Pharma: Consultancy, Honoraria; GlaxoSmithKline: Consultancy, Honoraria; Merck: Consultancy, Honoraria; Boehringer Ingelheim: Consultancy, Honoraria.

Background. Despite the improvement of therapeutic regimens, a relevant proportion of multiple myeloma (MM) patients (pts) experience early relapse (ER) [Majithia, Leukemia 2016] and represents an unmet medical need. It is therefore of high clinical interest to identify baseline factors that may predict ER. Aims To design models predictive of ER (defined as pts with a time-to-progression ≤18 or ≤ 24 months). To assess the accuracy of every model on an independent validation set. To build a score to predict ER. Methods Data were obtained from 2326 pts enrolled in 8 multi-center clinical trials: NCT01093196, NCT01346787, NCT01857115, NCT01190787, NCT00551928, NCT01091831, NCT01063179 and 2005-004730-41. Here, we included 14 baseline features (fts): age, creatinine, albumin (alb), b2microglobulin (b2m), bone marrow plasma cell (PCbm) were evaluated as continuous variables; free light chain (FLC, λ vs K), M-component subtype (IgA vs others), Revised International Staging System (R-ISS stage II/III vs I), lactate dehydrogenase levels >/≤ upper limit of normal (LDHULN), presence vs absence of chromosomal abnormalities detected by FISH [del17p, t(4;14), t(14;16), t(11;14)], and presence of plasmacytomas as categorical values. Trials were assigned to training and validation set to have a superimposed median (μe) age and follow-up in the two subsets. From the training set, a univariate analysis (UV) on outcome was performed according to both Chi-square and Kruskal tests, as appropriate. Features with p<0.05 were then tested in a multivariate (MV) logistic regression model. Each MV model was based on pts with complete data available. We performed and compared 2 MV models, one including R-ISS and one including fts (LDHULN, alb, b2m and chromosomal abnormalities) defining the R-ISS considered individually. Secondly, each model was tested on the validation set assessing the area under the curve (AUC). From the most accurate model, a score defined low (L), intermediate (I) and high (H) chances of ER. Statistical analysis was performed via R (v.3.5.2). Results ER≤18 models. 10/14 fts were selected based on UV analysis: age, FLC, PCbm, del17p, t(4/14), t(14/16), alb and b2m, LDHULN and R-ISS stage. Pts with complete data were included in the training set (n=923; μe age =66 years [y]; ER=35%) and the validation set (n=313; μe age=67 y; ER=36%), respectively. In the MV incorporating the R-ISS, the R-ISS II/III vs I (OR=1.75, 95% CI:1.26-2.44) and increased PCbm (OR=1.05, 95% CI:1.02-1.08) increased the risk of ER. When the MV analysis was performed including single fts instead of R-ISS, increased PCbm (OR=1.05, 95% CI:1.02-1.08), λ FLC (OR=1.34, 95% CI:1.01-1.79), LDHULN (OR=1.80, 95% CI:1.16-2.81), presence of both del17q (OR=1.58, 95% CI:1.07-2.33) and t(4/14) (OR=2.01, 95% CI:1.36-3.01) increased the probability of ER; increased alb (OR=0.75, 95% CI:0.61-0.94), reduced the risk of ER (table 1). ER≤24 models. 8/14 fts were selected based on UV analysis: FLC, PCbm, del17p, t(4/14), alb and b2m levels, LDHULN and R-ISS stage. Pts with complete data were included in the training set (n=1009; μe age=67 y; ER=45%) and in the validation set (n=352; μe age=67 y, ER=45%). In MV analysis, including R-ISS, both R-ISS (OR=1.88, 95% CI:1.39-2.55) and PCbm (OR=1.04, 95% CI:1.02-1.06) impacted on outcome. When the MV analysis was performed including single fts, λ FLC (OR=1.31, 95% CI:1.01-1.69), PCbm (OR=1.04, 95% CI:1.02-1.07), del17p (OR=1.86, 95% CI:1.30-2.65) and t(4/14) (OR=2.00, 95% CI:1.38-2.88) retained their impact on outcome (table 1). Validation. Each MV model was tested on the validation set. Among the 4 MV models, the ER≤18 incorporating individual fts resulted in the highest AUC (0.66) and was therefore used to build up a prognostic score. Score. The ER score was calculated as 0.047 × PCbm + 0.589 × LDHULN + 0.459 × del17q (IF present) + 0.705 × t(4/14) (IF present) + 0.293 × FLC (IF FLC =λ) - 0.284 × alb. The ER score was calculated as 3 groups of pts with different risks of ER: L (42% of pts; risk of ER18=23%), M (33% of pts; risk of ER18=39%) and H (26% of pts; risk of ER18 =55%). Discussion. This is the first analysis proposing a score that includes standard baseline fts and aims at identifying pts at high risk of ER in the context of novel agent-based therapy. Based on our score, 26% of pts can be defined at high risk. To improve the clinical applicability, the construction of a simplified model with categorized variables is ongoing. Disclosures Petrucci: Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen-Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees. Offidani:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees. Di Raimondo:Amgen: Consultancy, Honoraria, Research Funding; Takeda: Consultancy. Liberati:Amgen: Membership on an entity's Board of Directors or advisory committees, Other: Clinical trial support; Roche: Other: Clinical trial support; Novartis: Other: Clinical trial support; Janssen: Honoraria; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Clinical trial support; Celgene: Honoraria, Other: Clinical trial support; Bristol-Myers Squibb: Honoraria; Takeda: Membership on an entity's Board of Directors or advisory committees; Servier: Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Consultancy. Omedé:Janssen: Membership on an entity's Board of Directors or advisory committees. Mannina:Janssen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy. Caravita di Toritto:Celgene: Membership on an entity's Board of Directors or advisory committees, Other: Travel and accomodation costs, Research Funding; Johnson & Johnson: Membership on an entity's Board of Directors or advisory committees, Other: Travel and accomodation costs; Amgen: Membership on an entity's Board of Directors or advisory committees, Other: Travel and accomodation costs; Takeda: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees. Patriarca:Takeda: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Benevolo:Novartis Pharmaceuticals: Consultancy. Belotti:Amgen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees. Gaidano:AbbVie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Astra-Zeneca: Consultancy, Honoraria; Sunesys: Consultancy, Honoraria. Hajek:Amgen: Honoraria, Other: Consultant or advisory relationship, Research Funding; Celgene: Honoraria, Other: Consultant or advisory relationship, Research Funding; AbbVie: Other: Consultant or advisory relationship; Bristol-Myers Squibb: Honoraria, Other: Consultant or advisory relationship, Research Funding; Novartis: Other: Consultant or advisory relationship, Research Funding; PharmaMar: Honoraria, Other: Consultant or advisory relationship; Takeda: Honoraria, Other: Consultant or advisory relationship, Research Funding; Janssen: Honoraria, Other: Consultant or advisory relationship, Research Funding. Spencer:Sanofi: Other: Consulting/advisory role; Specialised Therapeutics Australia: Consultancy, Honoraria; Amgen: Other: Consulting/advisory role, Research Funding; AbbVie: Other: Consulting/advisory role, Research Funding; Haemalogix: Other: Consulting/advisory role; Janssen Oncology: Other: Consulting/advisory role, Research Funding, Speakers Bureau; Servier: Other: Consulting/advisory role; Secura Bio: Other: Consulting/advisory role; Takeda: Other: Consulting/advisory role, Research Funding; Celgene: Other: Consulting/advisory role, Research Funding, Speakers Bureau. Sonneveld:Amgen: Honoraria, Research Funding; BMS: Honoraria; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; SkylineDx: Research Funding. Boccadoro:Amgen: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; AbbVie: Honoraria; Mundipharma: Research Funding; Sanofi: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Gay:AbbVie: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: The presentation includes discussion of off-label use of a drug or drugs for the treatment of multiple myeloma.

BackgroundEarly goal-directed therapy (EGDT) is recommended in international guidance for the resuscitation of patients presenting with early septic shock. However, adoption has been limited and uncertainty remains over its clinical effectiveness and cost-effectiveness.ObjectivesThe primary objective was to estimate the effect of EGDT compared with usual resuscitation on mortality at 90 days following randomisation and on incremental cost-effectiveness at 1 year. The secondary objectives were to compare EGDT with usual resuscitation for requirement for, and duration of, critical care unit organ support; length of stay in the emergency department (ED), critical care unit and acute hospital; health-related quality of life, resource use and costs at 90 days and at 1 year; all-cause mortality at 28 days, at acute hospital discharge and at 1 year; and estimated lifetime incremental cost-effectiveness.DesignA pragmatic, open, multicentre, parallel-group randomised controlled trial with an integrated economic evaluation.SettingFifty-six NHS hospitals in England.ParticipantsA total of 1260 patients who presented at EDs with septic shock.InterventionsEGDT (n = 630) or usual resuscitation (n = 630). Patients were randomly allocated 1 : 1.Main outcome measuresAll-cause mortality at 90 days after randomisation and incremental net benefit (at £20,000 per quality-adjusted life-year) at 1 year.ResultsFollowing withdrawals, data on 1243 (EGDT,n = 623; usual resuscitation,n = 620) patients were included in the analysis. By 90 days, 184 (29.5%) in the EGDT and 181 (29.2%) patients in the usual-resuscitation group had died [p = 0.90; absolute risk reduction −0.3%, 95% confidence interval (CI) −5.4 to 4.7; relative risk 1.01, 95% CI 0.85 to 1.20]. Treatment intensity was greater for the EGDT group, indicated by the increased use of intravenous fluids, vasoactive drugs and red blood cell transfusions. Increased treatment intensity was reflected by significantly higher Sequential Organ Failure Assessment scores and more advanced cardiovascular support days in critical care for the EGDT group. At 1 year, the incremental net benefit for EGDT versus usual resuscitation was negative at −£725 (95% CI −£3000 to £1550). The probability that EGDT was more cost-effective than usual resuscitation was below 30%. There were no significant differences in any other secondary outcomes, including health-related quality of life, or adverse events.LimitationsRecruitment was lower at weekends and out of hours. The intervention could not be blinded.ConclusionsThere was no significant difference in all-cause mortality at 90 days for EGDT compared with usual resuscitation among adults identified with early septic shock presenting to EDs in England. On average, costs were higher in the EGDT group than in the usual-resuscitation group while quality-adjusted life-years were similar in both groups; the probability that it is cost-effective is < 30%.Future workThe ProMISe (Protocolised Management In Sepsis) trial completes the planned trio of evaluations of EGDT across the USA, Australasia and England; all have indicated that EGDT is not superior to usual resuscitation. Recognising that each of the three individual, large trials has limited power for evaluating potentially important subgroups, the harmonised approach adopted provides the opportunity to conduct an individual patient data meta-analysis, enhancing both knowledge and generalisability.Trial registrationCurrent Controlled Trials ISRCTN36307479.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 97. See the NIHR Journals Library website for further project information.

<p>The second ESMO Asia 2016 Congress, led by an international committee to promote the sharing of expertise and interaction between regional and international experts in oncology, returned for a second appearance at the Suntec Convention and Exhibition Centre in Singapore recently. Organized by the European Society for Medical Oncology (ESMO), the Asian leg of the annual scientific and educational congress was held from December 16–19th, 2016 and attended by over 2,000 healthcare professionals and exhibitors, including representatives from AMOR who were also present to cover the event. <br /> <br />ESMO Asia 2016 brought together oncologists from the Asian region and beyond to discuss important discoveries in oncology and to update delegates on the latest standards of care, the organizer noted in its media release. More specifically, delegates attending the meeting took the opportunity to exchange thoughts and ideas on current clinical challenges and novel treatment strategies for a variety of tumor subtypes, as well as to highlight emerging cancer therapeutics that are rapidly gaining attention in clinical settings. In addition to highlighting the latest in cancer research, the congress also sought to underscore bioethical, economic, and social challenges posed by cancer by addressing crucial issues such as the rising costs of treatments, the need for psychological support for patients, the need for better palliative care, and the vital importance of improving access to innovative drugs. <br /> <br />In this edition of the ESMO Asia congress, the keynote lectures consisted of two topics: how the differences between tumors can impact the design of effective treatments, and the link between common Epstein-Barr virus and nasopharyngeal cancer. With these two keynote lectures setting the tone for the congress, delegates saw a wide range of key discussions pertaining to the clinical relevance of molecular advances and innovative treatment approaches. Moreover, sessions that focus on improving current clinical understanding of various tumor types and novel treatment strategies for different tumor subtypes were also prominently featured. <br /> <br />In his opening remarks, ESMO President Prof. Fortunato Ciardiello said, “We are glad to be returning to Singapore for the second ESMO Asia Congress. Consolidating activities in Asia underlines the importance ESMO places on collaboration with partners in this region. The program this year will have a strong emphasis on state-of-the-art education and on the current standard of care across all major tumor types.” He continued, “In addition to practical seminars and wide-ranging discussions about how oncologists and other stakeholders can best collaborate for greater treatment results for cancer patients, delegates can look forward to opportunities for interaction with both local experts and key opinion leaders from the international oncology community.” <br /> <br />The opening ceremony was graced by the Guest-of-Honor – Dr. Amy Khor, Singapore’s Senior Minister of State for Health. In her speech, Dr. Khor laid emphasis on how events such as the ESMO Asia Congress are essential in providing an open platform to facilitate research collaboration. “To address the challenges presented by the complexity of cancer, the development of regional and international research networks is increasingly important to catalyze scientific communication and collaboration,” she said. To this end, Dr. Khor lauded the partnership between ESMO and the Singapore Society of Oncology in setting up a new office for cancer research aimed at facilitating collaborations between researchers in Europe and Asia — ESMO’s first footprint in Asia. “By building capabilities and strengthening our partnerships, we can do much more to improve patient care and treatment, especially for the Asian population,” she said. <br /> <br />Dr. Ravindran Kanesvaran, President of the host organization – Singapore Society of Oncology, echoed the sentiment. “Oncology is a rapidly evolving field that requires a multi-disciplinary approach between various healthcare professionals from different backgrounds and experience extending across all areas of cancer care trying their best to bring an end to this growing scourge. This collaborative endeavor is key to improve access, raise the quality of treatment delivery, and standard of cancer care in Singapore and Asia in general,” he stated. The cancer research office, which is yet to be officially named and launched, will open in the first quarter of 2017 at the National Cancer Centre Singapore and will administer educational grants, workshops, and conferences between Europe and Asia, Dr. Ravindran added. <br /> <br />The ESMO Asia 2016 Congress was supported by 20 of the most important and influential oncology associations in the region, including the Singapore Society of Oncology and the oncology societies from Australia, Bangladesh, China, Hong Kong, India, Indonesia, Iran, Japan, Malaysia, Myanmar, New Zealand, Pakistan, the Philippines, South Korea, Taiwan, Thailand and Uzbekistan. <br /> <br />During the congress, AMOR spoke to Dr. Susanna Hilda Hutajulu, a representative of the Indonesian Society of Hematology and Medical Oncology (ISHMO). Dr. Hutajulu is a practising medical oncologist in Indonesia who is actively involved in clinical research work and she is a regular participant of ESMO meetings, having recently attended ESMO 2016 in Copenhagen, Denmark. Dr. Susanna had also attended the inaugural ESMO Asia congress in 2015 and is an avid supporter of the congress’s multi-faceted agenda. On the development of cancer research in South East Asia, she told AMOR, “I agree that there should be a dedicated platform to showcase and promote the research work of oncology specialists and organizations in South East Asia.” <br /> <br />Dr. Hutajulu added, “Researchers in Indonesia place great importance in Scopus indexing when it comes to choosing the right journals to publish their research work in.” Meanwhile, the Myanmar Oncology Society (MOS) was represented by Dr. Shu Mon, who is based at the Thurein Mon Clinic in Yangon, Myanmar. During the congress, she gave a presentation on breast cancer management that is specific to the Myanmar experience. According to Dr. Shu Mon, there are only 30 qualified medical oncologists serving the whole of Myanmar, a country with a population of about 51 million people. On establishing collaborations with an academic journal, she said, “MOS is willing to work with a journal such as AMOR to promote the oncology research in Myanmar provided that there are suitable opportunities that both sides could agree on.”</p><p> </p><p>During the congress, Assoc. Prof. Dr. Ho Gwo Fuang, the guest managing editor for AMOR’s upcoming special issue and a representative of the Malaysian Oncological Society (MOS) at ESMO Asia 2016, was featured as one of the panelists of the ESMO-COS-MOS-NZSO Joint Symposium on ‘New insights into gastrointestinal cancers’. Dr. Ho, who is a medical oncologist at Malaysia’s University Malaya Medical Centre, delivered a talk entitled ‘Adjuvant aspirin for colorectal cancer? A cross-Asia collaborative effort’, a multi-nation initiative involving Singapore, Malaysia, and other Asia Pacific countries. His presentation offered strong scientific and observational data to support the adjuvant use of aspirin in reducing the formation of polyps and metastases after colorectal cancer diagnosis. Towards the end of his presentation, Dr. Ho highlighted the ongoing curation of AMOR’s Special Issue and invited his peers to submit papers to the journal for consideration.</p>

BackgroundWe studied the uptake of new classes of glucose lowering medications, such as Dipeptidyl peptidase-4 inhibitors (DPP4s) and Sodium-glucose cotransporter 2 inhibitors (SGLT2s) amongst patients living with type 2 diabetes. We compared this in Australia, Canada, England and Scotland, and explored whether these new drugs are supplementing or replacing older classes of medications. Research Design and MethodsWe used primary care Electronic Medical Data on prescriptions (Canada, UK) and dispensing data (Australia) from 2012 to 2017. We included persons aged 40 years or over on at least one glucose lowering medication in each year of interest; we excluded those on insulin only. We determined proportions of patients in each nation on each class of medication, as well as on combinations of classes. ResultsIn 2017, data from 28,063 patients in Canada, 106,000 in Australia, 88,953 in England and 15,603 in Scotland were included. The proportion of patients on metformin increased by 3.4% in Australia (95% CI: 3.24% to 3.55%) and decreased in the other nations. Canada had the greatest decrease, at 4.7% (95% CI: -5.05% to -4.34%). Sulfonylurea use decreased in most nations, while DPP4s increased in all. By 2017, between 10.1% and 15.3% of patients were on a SGLT2 and the use of either a DPP4 or SGLT2 combined with metformin approached or exceeded the use of sulfonylureas with metformin. ConclusionsNewer, more expensive medications are replacing sulfonylureas and, to a lesser degree, metformin. The effects of these trends on health outcomes and overall costs should be examined.

Abstract Canada receives worldwide attention for its single-payer and single-tier universal health coverage system, with hospital, diagnostic and primary care services free of user fees. The level of health spending and overall population health outcomes are comparable to other high-income countries such as France and Australia, but compared to the US Canada spends half as much on health care and achieves significantly better health outcomes. Nevertheless, it faces several challenges. One is providing financial access to other services. Pharmaceutical coverage is uneven and less generous than in comparable countries globally. Access to dental care, not covered for the general population, is challenging for the roughly one-third of the population lacking supplemental coverage, which nearly always is obtained through the workplace. The 2016 Commonwealth Fund international population surveys of 11 countries found that 41% of Canadians said they skipped dental care/check-ups in the past year due to costs - second highest among after the US. A second challenge is waiting for services. Canada shows the longest waits for specialist and surgical services. The third is stasis regarding adapting to changes in medicine and service delivery to improve quality and address major gaps in health across sub-populations such as Indigenous peoples. Innovations such as managed care and pay-for-performance lag behind most countries. Reform efforts aim to address fragmented care across providers, increase coverage, and reduce pharmaceutical costs. There are efforts to strengthen primary care, better coordinate across sectors, and reduce costly specialized care. There has also been increasing momentum to address financial barriers to accessing prescription drugs and containing pharmaceutical costs through a national “pharmacare” plan.

Abstract Background The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs. Objectives To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation. Methods Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed. Results Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments. Conclusions Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

ABSTRACTObjectiveThe majority of standard coding systems applied to health data are hierarchical: they start with several major categories and then each category is broken into subcategories across multiple levels. Running statistical models on these datasets, may lead to serious methodological challenges such as multicollinearity between levels or selecting suboptimal models as model space grows exponentially by adding each new level. The aim of this presentation is to introduce an analytical framework that addresses this challenge. ApproachData was from individuals who claimed Transport Accident Commission (TAC) compensation for motor vehicle accidents that occurred between 2010 and 2012 in the state of Victoria, Australia and provided consent for Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) linkage (n=738). PBS and MBS records dating from 12 months prior to injury were provided by the Department of Human Services (Canberra, Australia). Pre-injury use of health service items and pharmaceuticals were considered to indicate pre-existing health conditions. Both MBS and PBS listings have a hierarchical structure. The outcome was the cost of recovery; this was also hierarchical across four level (e.g. total, medical, consultations, and specialist). A Bayesian Model Averaging model was embedded into a data mining framework which automatically created all the cost outcomes and selected the best model after penalizing for multicollinearity. The model was run across multiple prior settings to ensure robustness. Monash University’s High Performance Computing Cluster was used for running approximately 5000 final models.ResultsThe framework successfully identified variables at different levels of hierarchy as indicators of pre-existing conditions that affect cost of recovery. For example, according to the results, on average, patients who received prescription pain or mental health related medication before the injury had 31.2% higher short-term and 36.9% higher long-term total recovery cost. For every anaesthetic in the year before the accident, post-injury hospital cost increased by 24%, for patients with anxiety it increased by 35.4%. For post-injury medical costs, every prescription of drugs used in diabetes (Category A10 in ATC) increased the cost by 8%, long term medical costs were affected by both pain and mental health. ConclusionBayesian model averaging provides a robust framework for mining hierarchically linked health data helping researchers to identify potential associations which may not have been discovered using conventional technique and also preventing them from identifying associations that are sporadic but not robust.

Abstract Background Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. Methods This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. Results Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference − 8%, 95% CI − 14 to − 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. Conclusions This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. Trial registration Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415.

On Wednesday 21 April the Minister for Communications, Information Technology and the Arts introduced a piece of legislation into the Australian Senate to regulate the way Australians use the Internet. This legislation is presented within Australia's existing system of content regulation, a scheme that the Minister describes is not censorship, but merely regulation (Alston 55). Underlying Senator Alston's rhetoric about the protection of children from snuff film makers, paedophiles, drug pushers and other criminals, this long anticipated bill is aimed at reducing the amount of pornographic materials available via computer networks, a censorship regime in an age when regulation and classification are the words we prefer to use when society draws the line under material we want to see, but dare not allow ourselves access to. Regardless of any noble aspirations expressed by free-speech organisations such as Electronic Frontiers Australia relating to the defence of personal liberty and freedom of expression, this legislation is about porn. Under the Bill, Australia would proscribe our citizens from accessing: explicit depictions of sexual acts between consenting adults; mild non-violent fetishes; depictions of sexual violence, coercion or non-consent of any kind; depictions of child sexual abuse, bestiality, sexual acts accompanied by offensive fetishes, or exploitative incest fantasies; unduly detailed and/or relished acts of extreme violence or cruelty; explicit or unjustifiable depictions of sexual violence against non-consenting persons; and detailed instruction or encouragement in matters of crime or violence or the abuse of proscribed drugs. (OFLC) The Australian public, as a whole, favour the availability of sexually explicit materials in some form, with OFLC data indicating a relatively high degree of public support for X rated videos, the "high end" of the porn market (Paterson et al.). In Australia strict regulation of X rated materials in conventional media has resulted in a larger illegal market for these materials than the legalised sex industries of the ACT and Northern Territory (while 1.2 million X rated videos are legally sold out of the territories, 2 million are sold illegally in other jurisdictions, according to Patten). In Australia, censorship of media content has traditionally been based on the principles of the protection of society from moral harm and individual degradation, with specific emphasis on the protection of innocents from material they are not old enough for, or mentally capable of dealing with (Joint Select Committee on Video Material). Even when governments distanced themselves from direct personal censorship (such as Don Chipp's approach to the censorship of films and books in the late 1960s and early 1970s) and shifted the rationale behind censorship from prohibition to classification, the publicly stated aims of these decisions have been the support of existing community standards, rather than the imposition of strict legalistic moral values upon an unwilling society. In the debates surrounding censorship, and especially the level of censorship applied (rather than censorship as a whole), the question "what is the community we are talking about here?" has been a recurring theme. The standards that are applied to the regulation of media content, both online and off, are often the focus of community debate (a pluralistic community that obviously lacks "standards" by definition of the word). In essence the problem of maintaining a single set of moral and ethical values for the treatment of media content is a true political dilemma: a problem that lacks any form of solution acceptable to all participants. Since the introduction of the Internet as a "mass" medium (or more appropriately, a "popular" one), government indecision about how best to treat this new technology has precluded any form or content regulation other than the ad hoc use of existing non-technologically specific law to deal with areas of criminal or legally sanctionable intent (such as the use of copyright law, or the powers under the Crimes Act relating to the improper use of telecommunications services). However, indecision in political life is often associated with political weakness, and in the face of pressure to act decisively (motivated again by "community concern"), the Federal government has decided to extend the role of the Australian Broadcasting Authority to regulate and impose a censorship regime on Australian access of morally harmful materials. It is important to note the government's intention to censor access, rather than content of the Internet. While material hosted in Australia (ignoring, of course, the "cyberspace" definitions of non-territorial existence of information stored in networks) will be censored (removed from Australia computers), the government, lacking extraterritorial powers to compel the owners of machines located offshore, intends to introduce of some form of refused access list to materials located in other nations. What is interesting to consider in this context is the way that slight shifts of definitional paradigm alter the way this legislation can be considered. If information flows (upon which late capitalism is becoming more dependent) were to be located within the context of international law governing the flow of waterways, does the decision to prevent travel of morally dubious material through Australia's informational waterways impinge upon the riparian rights of other nations (the doctrine of fair usage without impeding flow; Godana 50)? Similarly, if we take Smith's extended definition of community within electronic transactional spaces (the maintenance of members' commitment to the group, monitoring and sanctioning behaviour and the production and distribution of resources), then the current Bill proposes the regulation of the activities of one community by another (granted, a larger community that incorporates the former). Seen in this context, this legislation is the direct intervention in an established social order by a larger and less homogeneous group. It may be trite to quote the Prime Minister's view of community in this context, where he states ...It is free individuals, strong communities and the rule of law which are the best defence against the intrusive power of the state and against those who think they know what is best for everyone else. (Howard 21) possibly because the paradigm in which this new legislation is situated does not classify those Australians online (who number up to 3 million) as a community in their own right. In a way the Internet users of Australia have never identified themselves as a community, nor been asked to act in a communitarian manner. While discussions about the value of community models when applied to the Internet are still divided, there are those who argue that their use of networked services can be seen in this light (Worthington). What this new legislation does, however, is preclude the establishment of public communities in order to meet the desires of government for some limits to be placed on Internet content. The Bill does allow for the development of "restricted access systems" that would allow pluralistic communities to develop and engage in a limited amount of self-regulation. These systems include privately accessible Intranets, or sites that restrict access through passwords or some other form of age verification technique. Thus, ignoring the minimum standards that will be required for these communities to qualify for some measure of self-regulatory freedom, what is unspoken here is that specific subsections of the Internet population may exist, provided they keep well away from the public gaze. A ghetto without physical walls. Under the Bill, a co-regulatory approach is endorsed by the government, favouring the establishment of industry codes of practice by ISPs and (or) the establishment of a single code of practice by the content hosting industry (content developers are relegated to yet undetermined complementary state legislation). However, this section of the Bill, in mandating a range of minimum requirements for these codes of practice, and denying plurality to the content providers, places an administrative imperative above any communitarian spirit. That is, that the Internet should have no more than one community, it should be an entity bound by a single guiding set of principles and be therefore easier to administer by Australian censors. This administrative imperative re-encapsulates the dilemma faced by governments dealing with the Internet: that at heart, the broadcast and print press paradigms of existing censorship regimes face massive administrative problems when presented with a communications technology that allows for wholesale publication of materials by individuals. Whereas the limited numbers of broadcasters and publishers have allowed the development of Australia's system of classification of materials (on a sliding scale from G to RC classifications or the equivalent print press version), the new legislation introduced into the Senate uses the classification scheme simply as a censorship mechanism: Internet content is either "ok" or "not ok". From a public administration perspective, this allows government to drastically reduce the amount of work required by regulators and eases the burden of compliance costs by ISPs, by directing clear and unambiguous statements about the acceptability of existing materials placed online. However, as we have seen in other areas of social policy (such as the rationalisation of Social Security services or Health), administrative expedience is often antipathetic to small communities that have special needs, or cultural sensitivities outside of mainstream society. While it is not appropriate to argue that public administration creates negative social impacts through expedience, what can be presented is that, where expedience is a core aim of legislation, poor administration may result. For many Australian purveyors of pornography, my comments will be entirely unhelpful as they endeavour to find effective ways to spoof offshore hosts or bone up (no pun intended) on tunnelling techniques. Given the easy way in which material can be reconstituted and relocated on the Internet, it seems likely that some form of regulatory avoidance will occur by users determined not to have their content removed or blocked. For those regulators given the unenviable task of censoring Internet access it may be worthwhile quoting from Sexing the Cherry, in which Jeanette Winterson describes the town: whose inhabitants are so cunning that to escape the insistence of creditors they knock down their houses in a single night and rebuild them elsewhere. So the number of buildings in the city is always constant but they are never in the same place from one day to the next. (43) Thus, while Winterson saw this game as a "most fulfilling pastime", it is likely to present real administrative headaches to ABA regulators when attempting to enforce the Bill's anti-avoidance clauses. The Australian government, in adapting existing regulatory paradigms to the Internet, has overlooked the informal communities who live, work and play within the virtual world of cyberspace. In attempting to meet a perceived social need for regulation with political and administrative expedience, it has ignored the potentially cohesive role of government in developing self-regulating communities who need little government intervention to produce socially beneficial outcomes. In proscribing activity externally to the realm in which these communities reside, what we may see is a new type of community, one whose desire for a feast of flesh leads them to evade the activities of regulators who operate in the "meat" world. What this may show us is that in a virtual environment, the regulators' net is no match for a world wide web. References Alston, Richard. "Regulation is Not Censorship." The Australian 13 April 1999: 55. Paterson, K., et. al. Classification Issues: Film, Video and Television. Sydney: The Office of Film and Literature Classification, 1993. Patten, F. Personal interview. 9 Feb. 1999. Godana, B.A. Africa's Shared Water Resources: Legal and Institutional Aspects of the Nile, Niger and Senegal River Systems. London: Frances Pinter, 1985. Howard, John. The Australia I Believe In: The Values, Directions and Policy Priorities of a Coalition Government Outlined in 1995. Canberra: Liberal Party, 1995. Joint Select Committee On Video Material. Report of the Joint Select Committee On Video Material. Canberra: APGS, 1988. Office of Film and Literature Classification. Cinema & Video Ratings Guide. 1999. 1 May 1999 <http://www.oflc.gov.au/classinfo.php>. Smith, Marc A. "Voices from the WELL: The Logic of the Virtual Commons." 1998. 2 Mar. 1999 <http://www.sscnet.ucla.edu/soc/csoc/papers/voices/Voices.htm>. Winterson, Jeanette. Sexing the Cherry. New York: Vintage Books. 1991. Worthington, T. Testimony before the Senate Select Committee on Information Technologies. Unpublished, 1999. Citation reference for this article MLA style: Peter Chen. "Community without Flesh: First Thoughts on the New Broadcasting Services Amendment (Online Services) Bill 1999." M/C: A Journal of Media and Culture 2.3 (1999). [your date of access] <http://www.uq.edu.au/mc/9905/bill.php>. Chicago style: Peter Chen, "Community without Flesh: First Thoughts on the New Broadcasting Services Amendment (Online Services) Bill 1999," M/C: A Journal of Media and Culture 2, no. 3 (1999), <http://www.uq.edu.au/mc/9905/bill.php> ([your date of access]). APA style: Author. (1999) Community without flesh: first thoughts on the new broadcasting services amendment (online services) bill 1999. M/C: A Journal of Media and Culture 2(3). <http://www.uq.edu.au/mc/9905/bill.php> ([your date of access]).

Australian Scientists in Real-time Virtual Surgery. China Invests US$36 Million to Set up Plant Gene Banks. India, Germany to Jointly Promote Biotech Research. Firms Urged to Lower Costs of Anti-HIV Drugs. Japanese Private Sector May Stop Funds to AIDS Body. Malaysian Institute Collaborates with Drug Firm. Parkinson’s Disease Research Gets NZ$1.2 Million Funding. Online Food Composition Database Available. NZ Recalls Blood Pressure Medicine. Conference on Biotechnology Awareness in the Philippines. Singapore Sets up New Cancer Research Body. Singapore Attracts Attention of Life Sciences Firms. Thailand Ponders Adopting GM Crops.

Economics of Cute There are many ways to study cute: for example, neuro-biology (cute as adaptation); anthropology (cute in culture); political economy (cute industries, how cute exploits consumers); cultural studies (social construction of cute); media theory and politics (representation and identity of cute), and so on. What about economics? At first sight, this might point to a money-capitalism nexus (“the cute economy”), but I want to argue here that the economics of cute actually works through choice interacting with fixed costs and what economists call ”the substitution effect”. Cute, in conjunction with the Internet, affects the trade-offs involved in choices people make. Let me put that more starkly: cute shapes the economy. This can be illustrated with internet animals, which at the time of writing means Grumpy Cat. I want to explain how that mechanism works – but to do so I will need some abstraction. This is not difficult – a simple application of a well-known economics model, namely the Allen-Alchian theorem, or the “third law of demand”. But I am going to take some liberties in order to represent that model clearly in this short paper. Specifically, I will model just two extremes of quality (“opera” and “cat videos”) to represent end-points of a spectrum. I will also assume that the entire effect of the internet is to lower the cost of cat videos. Now obviously these are just simplifying assumptions “for the purpose of the model”. And the purpose of the model is to illuminate a further aspect of how we might understand cute, by using an economic model of choice and its consequences. This is a standard technique in economics, but not so in cultural studies, so I will endeavour to explain these moments as we go, so as to avoid any confusion about analytic intent. The purpose of this paper is to suggest a way that a simple economic model might be applied to augment the cultural study of cute by seeking to unpack its economic aspect. This can be elucidated by considering the rise of internet animals as a media-cultural force, as epitomized by “cat videos”. We can explain this through an application of price theory and the theory of demand that was first proposed by Armen Alchian and William Allen. They showed how an equal fixed cost that was imposed to both high-quality and low-quality goods alike caused a shift in consumption toward the higher-quality good, because it is now relatively cheaper. Alchian and Allen had in mind something like transport costs on agricultural goods (such as apples). But it is also true that the same effect works in reverse (Cowen), and the purpose of this paper is to develop that logic to contribute to explaining how certain structural shifts in production and consumption in digital media, particularly the rise of blog formats such as Tumblr, a primary supplier of kittens on the Internet, can be in part understood as a consequence of this economic mechanism. There are three key assumptions to build this argument. The first is that the cost of the internet is independent of what it carries. This is certainly true at the level of machine code, and largely true at higher levels. What might be judged aesthetically high quality or low quality content – say of a Bach cantata or a funny cat video – are treated the same way if they both have the same file size. This is a physical and computational aspect of net-neutrality. The internet – or digitization – functions as a fixed cost imposed regardless of what cultural quality is moving across it. Second, while there are costs to using the internet (for example, in hardware or concerning digital literacy) these costs are lower than previous analog forms of information and cultural production and dissemination. This is not an empirical claim, but a logical one (revealed preference): if it were not so, people would not have chosen it. The first two points – net neutrality and lowered cost – I want to take as working assumptions, although they can obviously be debated. But that is not the purpose of the paper, which is instead the third point – the “Alchian-Allen theorem”, or the third fundamental law of demand. The Alchian-Allen Theorem The Alchian-Allen theorem is an extension of the law of demand (Razzolini et al) to consider how the distribution of high quality and low quality substitutes of the same good (such as apples) is affected by the imposition of a fixed cost (such as transportation). It is also known as the “shipping the good apples out” theorem, after Borcherding and Silberberg explained why places that produce a lot of apples – such as Seattle in the US – often also have low supplies of high quality apples compared to places that do not produce apples, such as New York. The puzzle of “why can’t you get good apples in Seattle?” is a simple but clever application of price theory. When a place produces high quality and low quality items, it will be rational for those in faraway places to consume the high quality items, and it will be rational for the producers to ship them, leaving only the low quality items locally.Why? Assume preferences and incomes are the same everywhere and that transport cost is the same regardless of whether the item shipped is high or low quality. Both high quality and low quality apples are more expensive in New York compared to Seattle, but because the fixed transport cost applies to both the high quality apples are relatively less expensive. Rational consumers in New York will consume more high quality apples. This makes fewer available in Seattle.Figure 1: Change in consumption ratio after the imposition of a fixed cost to all apples Another example: Australians drink higher quality Californian wine than Californians, and vice versa, because it is only worth shipping the high quality wine out. A counter-argument is that learning effects dominate: with high quality local product, local consumers learn to appreciate quality, and have different preferences (Cowen and Tabarrok).The Alchian-Allen theorem applies to any fixed cost that applies generally. For example, consider illegal drugs (such as alcohol during the US prohibition, or marijuana or cocaine presently) and the implication of a fixed penalty – such as a fine, or prison sentence, which is like a cost – applied to trafficking or consumption. Alchian-Allen predicts a shift toward higher quality (or stronger) drugs, because with a fixed penalty and probability of getting caught, the relatively stronger substance is now relatively cheaper. Empirical work finds that this effect did occur during alcohol prohibition, and is currently occurring in narcotics (Thornton Economics of Prohibition, "Potency of illegal drugs").Another application proposed by Steven Cuellar uses Alchian-Allen to explain a well-known statistical phenomenon why women taking the contraceptive pill on average prefer “more masculine” men. This is once again a shift toward quality predicted on falling relative price based on a common ‘fixed price’ (taking the pill) of sexual activity. Jean Eid et al show that the result also applies to racehorses (the good horses get shipped out), and Staten and Umbeck show it applies to students – the good students go to faraway universities, and the good student in those places do the same. So that’s apples, drugs, sex and racehorses. What about the Internet and kittens?Allen-Alchian Explains Why the Internet Is Made of CatsIn analog days, before digitization and Internet, the transactions costs involved with various consumption items, whether commodities or media, meant that the Alchian-Allen effect pushed in the direction of higher quality, bundled product. Any additional fixed costs, such as higher transport costs, or taxes or duties, or transactions costs associated with search and coordination and payment, i.e. costs that affected all substitutes in the same way, would tend to make the higher quality item relatively less expensive, increasing its consumption.But digitisation and the Internet reverse the direction of these transactions costs. Rather than adding a fixed cost, such as transport costs, the various aspects of the digital revolution are equivalent to a fall in fixed costs, particularly access.These factors are not just one thing, but a suite of changes that add up to lowered transaction costs in the production, distribution and consumption of media, culture and games. These include: The internet and world-wide-web, and its unencumbered operation The growth and increasing efficacy of search technology Growth of universal broadband for fast, wide band-width access Growth of mobile access (through smartphones and other appliances) Growth of social media networks (Facebook, Twitter; Metcalfe’s law) Growth of developer and distribution platforms (iPhone, android, iTunes) Globally falling hardware and network access costs (Moore’s law) Growth of e-commerce (Ebay, Amazon, Etsy) and e-payments (paypal, bitcoin) Expansions of digital literacy and competence Creative commons These effects do not simply shift us down a demand curve for each given consumption item. This effect alone simply predicts that we consume more. But the Alchian-Allen effect makes a different prediction, namely that we consume not just more, but also different.These effects function to reduce the overall fixed costs or transactions costs associated with any consumption, sharing, or production of media, culture or games over the internet (or in digital form). With this overall fixed cost component now reduced, it represents a relatively larger decline in cost at the lower-quality, more bite-sized or unbundled end of the media goods spectrum. As such, this predicts a change in the composition of the overall consumption basket to reflect the changed relative prices that these above effects give rise to. See Figure 2 below (based on a blog post by James Oswald). The key to the economics of cute, in consequence of digitisation, is to follow through the qualitative change that, because of the Alchian-Allen effect, moves away from the high-quality, highly-bundled, high-value end of the media goods spectrum. The “pattern prediction” here is toward more, different, and lower quality: toward five minutes of “Internet animals”, rather than a full day at the zoo. Figure 2: Reducing transaction costs lowers the relative price of cat videos Consider five dimensions in which this more and different tendency plays out. Consumption These effects make digital and Internet-based consumption cheaper, shifting us down a demand curve, so we consume more. That’s the first law of demand in action: i.e. demand curves slope downwards. But a further effect – brilliantly set out in Cowen – is that we also consume lower-quality media. This is not a value judgment. These lower-quality media may well have much higher aesthetic value. They may be funnier, or more tragic and sublime; or faster, or not. This is not about absolute value; only about relative value. Digitization operating through Allen-Alchian skews consumption toward the lower quality ends in some dimensions: whether this is time, as in shorter – or cost, as in cheaper – or size, as in smaller – or transmission quality, as in gifs. This can also be seen as a form of unbundling, of dropping of dimensions that are not valued to create a simplified product.So we consume different, with higher variance. We sample more than we used to. This means that we explore a larger information world. Consumption is bite-sized and assorted. This tendency is evident in the rise of apps and in the proliferation of media forms and devices and the value of interoperability.ProductionAs consumption shifts (lower quality, greater variety), so must production. The production process has two phases: (1) figuring out what to do, or development; and (2) doing it, or making. The world of trade and globalization describes the latter part: namely efficient production. The main challenge is the world of innovation: the entrepreneurial and experimental world of figuring out what to do, and how. It is this second world that is radically transformed by implications of lowered transaction costs.One implication is growth of user-communities based around collaborative media projects (such as open source software) and community-based platforms or common pool resources for sharing knowledge, such as the “Maker movement” (Anderson 2012). This phenomenon of user-co-creation, or produsers, has been widely recognized as an important new phenomenon in the innovation and production process, particularly those processes associated with new digital technologies. There are numerous explanations for this, particularly around preferences for cooperation, community-building, social learning and reputational capital, and entrepreneurial expectations (Quiggin and Potts, Banks and Potts). Business Models The Alchian-Allen effect on consumption and production follows through to business models. A business model is a way of extracting value that represents some strategic equilibrium between market forms, organizational structures, technological possibilities and institutional framework and environmental conditions that manifests in entrepreneurial patterns of business strategy and particular patterns of investment and organization. The discovery of effective business models is a key process of market capitalist development and competition. The Alchian-Allen effect impacts on the space of effective viable business models. Business models that used to work will work less well, or not at all. And new business models will be required. It is a significant challenge to develop these “economic technologies”. Perhaps no less so than development of the physical technologies, new business models are produced through experimental trial and error. They cannot be known in advance or planned. But business models will change, which will affect not only the constellation of existing companies and the value propositions that underlie them, but also the broader specializations based on these in terms of skill sets held and developed by people, locations of businesses and people, and so on. New business models will emerge from a process of Schumpeterian creative destruction as it unfolds (Beinhocker). The large production, high development cost, proprietary intellectual property and systems based business model is not likely to survive, other than as niche areas. More experimental, discovery-focused, fast-development-then-scale-up based business models are more likely to fit the new ecology. Social Network Markets & Novelty Bundling MarketsThe growth of variety and diversity of choice that comes with this change in the way media is consumed to reflect a reallocation of consumption toward smaller more bite-sized, lower valued chunks (the Alchian-Allen effect) presents consumers with a problem, namely that they have to make more choices over novelty. Choice over novelty is difficult for consumers because it is experimental and potentially costly due to risk of mistakes (Earl), but it also presents entrepreneurs with an opportunity to seek to help solve that problem. The problem is a simple consequence of bounded rationality and time scarcity. It is equivalent to saying that the cost of choice rises monotonically with the number of choices, and that because there is no way to make a complete rational choice, agents will use decision or choice heuristics. These heuristics can be developed independently by the agents themselves through experience, or they can be copied or adopted from others (Earl and Potts). What Potts et al call “social network markets” and what Potts calls “novelty bundling markets” are both instances of the latter process of copying and adoption of decision rules. Social network markets occur when agents use a “copy the most common” or “copy the highest rank” meta-level decision rule (Bentley et al) to deal with uncertainty. Social network markets can be efficient aggregators of distributed information, but they can also be path-dependent, and usually lead to winner-take all situations and dynamics. These can result in huge pay-offs differentials between first and second or fifth place, even when the initial quality differentials are slight or random. Diversity, rapid experimentation, and “fast-failure” are likely to be effective strategies. It also points to the role of trust and reputation in using adopted decision rules and the information economics that underlies that: namely that specialization and trade applies to the production and consumption of information as well as commodities. Novelty bundling markets are an entrepreneurial response to this problem, and observable in a range of new media and creative industries contexts. These include arts, music or food festivals or fairs where entertainment and sociality is combined with low opportunity cost situations in which to try bundles of novelty and connect with experts. These are by agents who developed expert preferences through investment and experience in consumption of the particular segment or domain. They are expert consumers and are selling their “decision rules” and not just the product. The more production and consumption of media and digital information goods and services experiences the Alchian-Allen effect, the greater the importance of novelty bundling markets. Intellectual Property & Regulation A further implication is that rent-seeking solutions may also emerge. This can be seen in two dimensions; pursuit of intellectual property (Boldrin and Levine); and demand for regulations (Stigler). The Alchian-Allen induced shift will affect markets and business models (and firms), and because this will induce strategic defensive and aggressive responses from different organizations. Some organizations will seek to fight and adapt to this new world through innovative competition. Other firms will fight through political connections. Most incumbent firms will have substantial investments in IP or in the business model it supports. Yet the intellectual property model is optimized for high-quality large volume centralized production and global sales of undifferentiated product. Much industrial and labour regulation is built on that model. How governments support such industries is predicated on the stability of this model. The Alchian-Allen effect threatens to upset that model. Political pushback will invariably take the form of opposing most new business models and the new entrants they carry. Conclusion I have presented here a lesser-known but important theorem in applied microeconomics – the Alchian-Allen effect – and explain why its inverse is central to understanding the evolution of new media industries, and also why cute animals proliferate on the Internet. The theorem states that when a fixed cost is added to substitute goods, consumers will shift to the higher quality item (now relatively less expensive). The theorem also holds in reverse, when a fixed cost is removed from substitute items we expect a shift to lower quality consumption. The Internet has dramatically lowered fixed costs of access to media consumption, and various development platforms have similarly lowered the costs of production. Alchian-Allen predicts a shift to lower-quality, ”bittier” cuter consumption (Cowen). References Alchian, Arman, and William Allen. Exchange and Production. 2nd ed. Belmont, CA: Wadsworth, 1967. Anderson, Chris. Makers. New York: Crown Business, 2012. Banks, John, and Jason Potts. "Consumer Co-Creation in Online Games." New Media and Society 12.2 (2010): 253-70. Beinhocker, Eric. Origin of Wealth. Cambridge, Mass.: Harvard University Press, 2005. Bentley, R., et al. "Regular Rates of Popular Culture Change Reflect Random Copying." Evolution and Human Behavior 28 (2007): 151-158. Borcherding, Thomas, and Eugene Silberberg. "Shipping the Good Apples Out: The Alchian and Allen Theorem Reconsidered." Journal of Political Economy 86.1 (1978): 131-6. Cowen, Tyler. Create Your Own Economy. New York: Dutton, 2009. (Also published as The Age of the Infovore: Succeeding in the Information Economy. Penguin, 2010.) Cowen, Tyler, and Alexander Tabarrok. "Good Grapes and Bad Lobsters: The Alchian and Allen Theorem Revisited." Journal of Economic Inquiry 33.2 (1995): 253-6. Cuellar, Steven. "Sex, Drugs and the Alchian-Allen Theorem." Unpublished paper, 2005. 29 Apr. 2014 ‹http://www.sonoma.edu/users/c/cuellar/research/Sex-Drugs.pdf›.Earl, Peter. The Economic Imagination. Cheltenham: Harvester Wheatsheaf, 1986. Earl, Peter, and Jason Potts. "The Market for Preferences." Cambridge Journal of Economics 28 (2004): 619–33. Eid, Jean, Travis Ng, and Terence Tai-Leung Chong. "Shipping the Good Horses Out." Wworking paper, 2012. http://homes.chass.utoronto.ca/~ngkaho/Research/shippinghorses.pdf Potts, Jason, et al. "Social Network Markets: A New Definition of Creative Industries." Journal of Cultural Economics 32.3 (2008): 166-185. Quiggin, John, and Jason Potts. "Economics of Non-Market Innovation & Digital Literacy." Media International Australia 128 (2008): 144-50. Razzolini, Laura, William Shughart, and Robert Tollison. "On the Third Law of Demand." Economic Inquiry 41.2 (2003): 292–298. Staten, Michael, and John Umbeck. “Shipping the Good Students Out: The Effect of a Fixed Charge on Student Enrollments.” Journal of Economic Education 20.2 (1989): 165-171. Stigler, George. "The Theory of Economic Regulation." Bell Journal of Economics 2.1 (1971): 3-22. Thornton, Mark. The Economics of Prohibition. Salt Lake City: University of Utah Press, 1991.Thornton, Mark. "The Potency of Illegal Drugs." Journal of Drug Issues 28.3 (1998): 525-40.

“Live free or die!” (New Hampshire State motto) Should individuals be free to make lifestyle decisions (such as what, when and how much to eat and how much physical activity to take), without undue interference from the state, even when their decisions may lead to negative consequences (obesity, heart disease, diabetes)? The UN Declaration of Human Rights enshrines the belief that “All human beings are born free and equal in dignity and rights”. The philosophy of Libertarianism (Locke) proposes that rights can be negative (e.g. the freedom to be free from outside interference) as well as positive (e.g. the right to certain benefits supplied by others). Robert Nozick, a proponent of Libertarianism, has argued that we have the right to make informed decisions about our lives without unnecessary interference. This entitlement requires that we exercise our rights only as far as they do not infringe the rights of others. The popular notion of the “Nanny State” (often used derogatively) is discussed, and the metaphor is extended to draw on the Super Nanny phenomenon, a reality television series that has been shown in numerous countries including the UK, the US, and Australia. It is argued in this paper that social marketing, when done well, can help create a “Super Nanny State” (implying positive connotations). In the “Nanny State” people are told what to do; in the “Super Nanny State” people are empowered to make healthier decisions. Social marketing applies commercial marketing principles to “sell” ideas (rather than goods or services) with the aim of improving the welfare of individuals and/or society. Where the common good may not be easily discerned, Donovan and Henley recommended using the UN Declaration of Human Rights as the baseline reference point. Social marketing is frequently used to persuade individuals to make healthier lifestyle decisions such as “eat less [saturated] fat”, “eat two fruits and five veg a day”, “find thirty minutes of physical activity a day”. Recent medical gains in immunisation, sanitation and treating infectious diseases mean that the health of a population can now be more improved by influencing lifestyle decisions than by treating illness (Rothschild). Social marketing activities worldwide are directed at influencing lifestyle decisions to prevent or minimise lifestyle diseases. “Globesity” is the new epidemic (Kline). Approximately one billion people globally are overweight or obese (compared to 850 million who are underweight); most worryingly, about 10% of children worldwide are now overweight or obese with rising incidence of type 2 diabetes in this population (Yach, Stuckler, and Brownwell). “Nanny state” is a term people often use derogatively to refer to government intervention (see Henley and Jackson). Knag (405) made a distinction between old-style, authoritarian “paternalism”, which chastised the individual using laws and sanctions, and a newer “maternalism” or “nanny state” which smothers the individual with “education and therapy (or rather, propaganda and regulation)”. Knag’s use of the term “Nanny State” still has pejorative connotations. In the “Nanny State”, governments are seen as using the tool of social marketing to tell people what they should and shouldn’t do, as if they were children being supervised by a nanny. At the extreme, people may be afraid that social marketing could be used by the State as a way to control the thoughts of the vulnerable, a view expressed some years ago by participants in a survey of attitudes towards social marketing (Laczniak, Lusch, and Murphy). More recently, the debate is more likely to focus on why social marketing often appears to be ineffective, rather than frighteningly effective (Hastings, Stead, and Macintosh). Another concern is the high level of fear being generated by much of the social marketing effort (Hastings and MacFadyen; Henley). It is as if nanny thinks she must scream at her children all the time to warn them that they will die if they don’t listen to her. However, by extension, I am suggesting that the “Super Nanny State” metaphor could have positive associations, with an authoritative (rather than authoritarian) parenting figure, one who explains appropriate sanctions (laws and regulations) but who is also capable of informing, inspiring and empowering. Still, the Libertarian ethical viewpoint would question whether governments, through social marketers, have the right to try to influence people’s lifestyle decisions such as what and how much to eat, how much to exercise, etc. In the rise of the “Nanny State”, Holt argued that governments are extending the range of their regulatory powers, restricting free markets and intruding into areas of personal responsibility, all under the guise of acting for the public’s good. A number of arguments, discussed below, can be proposed to justify interference by the State in the lifestyle decisions of individuals. The Economic Argument One argument that is often quoted to justify interference by the State is that the economic costs of allowing unsafe/unhealthy behaviours have to be borne by the community. It has been estimated in the US that medical costs relating to diabetes (which is associated directly with obesity) increased from $44 billion to $92 billion in five years (Yach, et al). The economic argument can be useful for persuading governments to invest in prevention but is not sufficient as a fundamental justification for interference. If we say that we want people to eat more healthily because their health costs will be burdensome to the community, we imply that we would not ask them to do so if their health costs were not burdensome, even if they were dying prematurely as a result. The studies relating to the economic costs of obesity have not been as extensive as those relating to the economic costs of tobacco (Yach, et al), where some have argued that prematurely dying of smoking-related diseases is less costly to the State than the costs incurred in living to old age (Barendregt, et al). This conclusion has been disputed (Rasmussen et al), but even if true, would not provide sufficient justification to cease tobacco control efforts. Similarly, I think people would expect social marketing efforts relating to nutrition and physical activity to continue even if an economic analysis showed that people dying prematurely from obesity-related illnesses were costing the State less overall in health care costs than people living an additional twenty years. The Consumer Protection Argument Some degree of interference by the State is desirable and often necessary because people are not entirely self-reliant in every circumstance (Mead). The social determinants of health (Marmot and Wilkinson) are sufficiently well-understood to justify government regulation to reduce inequalities in housing, education, access to health services, etc. Implicit in the criticism that the “Nanny State” treats people like children is the assumption that children are treated without dignity and respect. The positive parent or “Super Nanny” treats children with respect but recognises their vulnerability in unfamiliar or dangerous contexts. A survey of opinion in the UK in 2004 by the King’s Fund, an independent think tank, found that the public generally supported government initiatives to encourage healthier school meals; ensure cheaper fruit and vegetables; pass laws to limit salt, fat and sugar in foods; stop advertising junk foods for children and regulate for nutrition labels on food (UK public wants a “Nanny State”). The UK’s recently established National Social Marketing Centre has made recommendations for social marketing strategies to improve public health and Prime Minister Tony Blair has responded by making public health, especially the growing obesity problem, a central issue for government initiatives, offering a “helping hand” approach (Triggle). The Better Alternative Argument Wikler considered the case for more punitive government intervention in the obesity debate by weighing the pros and cons of an interesting strategy: the introduction of a “fat tax” that would require citizens to be weighed and, if found to be overweight, require them to pay a surcharge. He concluded that this level of state interference would not be justified because there are other ways to appeal to the risk-taker’s autonomy, through education and therapeutic efforts. Governments can use social marketing as one of these better alternatives to punitive sanctions. The Level Playing Field Argument Social marketers argue that many lifestyle behaviours are not entirely voluntary (O’Connell and Price). For example, it is argued that an individual’s choices about eating fast food, consuming sweetened soft drinks, and living sedentary lives have already been partially determined by commercial efforts. Thus, they argue that social marketing efforts are intended to level the playing field – educate, inform, and restore true personal autonomy to people, enabling them to make rational choices (Smith). For example, Kline’s media education program in Canada, with a component of “media risk reduction”, successfully educated young consumers (elementary school children) with strategies for “tuning out” by asking them to come up with a plan for what they would do if they “turned off TV, video games and PCs for a whole week?” (p. 249). The “tune out challenge” resulted in a reduction of media exposure (80%) displaced into active leisure pursuits. A critical aspect of this intervention was the contract drawn up in advance, with the children setting their own goals and strategies (Kline). In this view, the state is justified in trying to level the playing field, by using social marketing to offer information as well as alternative, healthier choices that can be freely accepted or rejected (Rothschild). Conclusion A real concern is that when people are treated like children, they become like children, retaining their desires and appetites but abdicating responsibility for their individual choices to the state (Knag). Some smokers, for example, declare that they will continue to smoke until the government bans smoking (Brown). Governments and social marketers have a responsibility to fund/design campaigns so that the audience views the message as informative rather than proscriptive. Joffe and Mindell (967) advocated the notion of a “canny state” with “less reliance on telling people what to do and more emphasis on making healthy choices easier”. Finally, one of the central tenets of marketing is the concept of “exchange” – the marketer must identify the benefits to be gained from buying a product. In social marketing terms, interference in an individual’s right to act freely can be effective and justified when the benefits are clearly identifiable and credible. Rothschild described marketing’s role as providing a middle point between libertarianism and paternalism, offering free choice and incentives to behave in ways that benefit the common good. Rather than shaking a finger at the individual (along the lines of earlier “Don’t Do Drugs” campaigns), the “Super Nanny” state, via social marketing, can inform and engage individuals in ways that make healthier choices more appealing and the individual feel more empowered to choose them. 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