Perspectives

No. Breast cancer researchers Robin Bell and Robert Burton believe that screening can result in overdiagnosis Screening mammography undoubtedly saves lives. Since 1991, when Australia’s free national mammographic screening program (BreastScreen Australia) began, there has been a 29% reduction in breast cancer-specific mortality. However, our analysis of age-stratified data indicates that BreastScreen does not account for most of this mortality reduction.1 Furthermore, it is now recognised that the balance between the benefits and harms of screening has become increasingly unfavourable. Women should be given a balanced explanation of what BreastScreen offers them. Our study analysed age-specific trends in breast cancer incidence, mortality and BreastScreen participation by Australian women aged 40–79 years since 1991.1 We found that the participation rates and relative mortality declines were the opposite of what the randomised controlled trials (RCTs) of mammographic screening had predicted. Women aged 40–49 years, who had the lowest BreastScreen participation (about 20%), had the largest mortality reduction (43.6%; 95% CI, 34.8%–51.2%). Women aged 60–69 years, who had the highest BreastScreen participation (about 60%), had the smallest mortality reduction (19.1%; 95% CI, 10.5%–26.9%). We also analysed the proportions of the declines in absolute breast cancer-specific mortality from 1991 to 2007 in two parts (before and after 1999–2000), to identify periods before and after any effect of BreastScreen on mortality might have been expected. We found that only about a third of the reduction in mortality in the age group invited for screening (50–69 years) occurred after 1999–2000.1 We have calculated the contribution that adjuvant endocrine therapy and chemotherapy could have made to the reduction in breast cancer mortality in Australia since 1991. Australia is unique in having six datasets from population-based breast cancer treatment surveys between 1986 and 1999. These document the stage at diagnosis and adjuvant treatment received for early breast cancer for different samples of Australian women. Based on a 10–15-year follow-up of their overviews of RCTs of adjuvant therapy in early breast cancer between 1985 and 2000, the Early Breast Cancer Trialists Collaborative Group (EBCTCG) concluded that appropriate use of anthracycline-based chemotherapy followed by tamoxifen for oestrogen-receptor-positive disease would result in annual breast cancer mortality reductions of 57% for oestrogen-receptor-positive women < 50 years of age and 45% for those aged 50–69 years.2 Our analysis, using 1999 Victorian survey results and the EBCTCG overview, found that breast cancer mortality reductions in Australian women in 1999 from adjuvant endocrine therapy and chemotherapy could have been up to 38% for women aged 40–49 years, and up to 24% for women aged ≥ 50 years.1 Therefore, adjuvant therapy had the potential to produce most of the 29% reduction in breast cancer mortality in Australia since 1991. In theory, screening for an asymptomatic earlier stage of a disease that is more effectively treated with available therapies than symptomatic disease will produce less morbidity and mortality, but screening can result in overdiagnosis. Overdiagnosed breast cancers are those detected by screening mammography that would not have become symptomatic in the woman’s lifetime. Overdiagnosis by mammographic screening is most accurately estimated from the RCTs by comparing the increased numbers of breast cancers diagnosed in women invited to undergo screening compared with those not invited. A recent Cochrane systematic review of the RCTs puts the estimate at 30%.3 An estimate from incidence trends in New South Wales indicated that 30%–40% of invasive breast cancers were overdiagnosed in 1999–2001.4 The benefits and harms of mammographic screening are measured in terms of the ratio of lives saved to cases overdiagnosed. Using the RCT data, the 2011 Cochrane review determined that, with 30% overdiagnosis and a relative mortality reduction of 15%, “for every 2000 women invited for screening throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and treated unnecessarily”.3 As the outcome of treatment for both symptomatic and asymptomatic disease improves, the impact of screening diminishes and the balance of benefits to harms will become less favourable. This has serious implications for health policymakers. We believe it is time for women to be presented with a more balanced view about the benefits and harms of breast screening. Screening programs are currently undergoing review in the United Kingdom, and one of the first commitments is to a new process of developing written information for the public that will synthesise information on benefits and harms. There has been an assurance that the leaflet about breast cancer screening will be among the first to be revised.5

Robin J Bell PhD, MPH, FAFPHM · Robert C Burton MD, PhD, FRACS

Lack of audit control and inability to adapt to change leads to massive waste As Director of Professional Services Review (a role established to protect the integrity of Medicare and the Pharmaceutical Benefits Scheme) for over 6 years, I gained an insider’s insight into how dysfunctional the Medicare/Medibank Scheme has become since the Health Insurance Act 1973 (Cwlth) was introduced. The then Minister for Health, the Hon. Bill Hayden, stated in his second reading speech that the purpose of the scheme was to create the “most equitable and efficient means of providing health insurance coverage for all Australians”.1 The universality of medical insurance coverage benefited all Australians, particularly those for whom a doctor’s visit represented a significant proportion of income. From the beginning, there were inadequate safeguards in a scheme based on the honour system. In no other area of public expenditure where recipients have significant control has so little attention been paid to audit. Medicare Australia administers over half a billion transactions every year for the Medicare Benefits Schedule (MBS) and the Pharmaceutical Benefits Scheme (PBS). Medicare is very efficient at its core business — that of distributing benefits. Electronic claiming has addressed criticism of earlier inefficiencies. However, Medicare’s ability to ensure benefits have been paid appropriately has never fully coped with the medical business environment. Extrapolating modestly from the misuse of the MBS, PBS and the Medicare Safety Net (financial assistance for high out-of-pocket costs for out-of-hospital MBS services) that I am directly aware of, I estimate that 2–3 billion dollars are spent inappropriately each year. Unfortunately, there are no attempts to quantify these losses more accurately. The reasons for this leakage are diverse. The MBS is riddled with misdirected incentives for practitioners, contains items that have not been reviewed despite advances in technology, and has many examples of good public policy thwarted by the MBS rules. In general practice, general practice management plans (GPMPs) and team care arrangements (TCAs) have created opportunities for a bonanza for some practices. Several practitioners I have reported on had admitted that their corporate owner had a business plan based on a defined number of these items claimed every week, irrespective of clinical need. Medicare Australia is also aware that a significant proportion of these plans are not carried out by a patient’s usual doctor’s practice.2 Anecdotally, claiming for clinically unnecessary GPMPs is significant throughout Australia. The policy intent of GPMPs was to provide a higher standard of care for patients with complicated chronic disease. While many doctors use these items appropriately for positive patient outcomes, a proportion of claimed items have added nothing materially to patient care. The TCA items are based on a model of care that works well in an inpatient setting, but does not translate to general practice. This item has created a whole industry of allied health practitioners and dentists who, through a TCA, draw on the public purse. Under a TCA, there is incentive for doctors to be pressured to provide the paperwork for “free” podiatry, physiotherapy, psychology, and dental care, facilitated by computer systems that can generate the necessary paperwork in minutes. The MBS rebate for a GPMP is $138.75, and for a TCA is $109.95. The policy intention was to allow patients with chronic or terminal disease to receive previously unaffordable care, but has created perverse incentives for all parties involved. This is bleeding several hundred million dollars per year as the policy intention is buried by inappropriate claims. The approach of the Department of Health and Ageing (DoHA) in not allowing discretion to doctors to refer purely on clinical grounds has led to this situation. The policy intent by government was sound. However, the DoHA developed MBS items that create incentives to easily misuse and work around the MBS requirements, leading to their misuse by a proportion of both medical and allied health practitioners. Some practitioners consciously misuse the MBS occasionally, and some do so regularly. The policy intent could have been achieved by allowing direct referral, without financial incentive to the doctor. This measure alone would have saved the health budget well over a billion dollars over the life of the program. Instead, a monster was created, eroding the integrity of the health budget. Items are added to the MBS after a long and exhaustive process of evaluation. This includes consideration of the skill level involved, the cost of necessary equipment, time taken for a procedure, and the overall cost–benefit to the community. However, once items are on the MBS, as long as they are still being used, they are rarely re-evaluated, and they attract the yearly rise in benefit level. Minister Roxon, in her first term as Minister for Health, bravely tried to reduce ophthalmologists’ fees for cataract surgery by 50%.3 These items were introduced when the procedure was not considered routine, took much longer than today, and required an inpatient stay of more than a week. The benefit reflected this. In the nearly 40 years since, technology has moved on and now this surgery can be performed under local anaesthetic as a day-procedure lasting 20 minutes. Private patients are sometimes charged more than $4000 for this procedure. In the end, the Minister was only able to achieve a 12% reduction on the MBS fee.4 The top providers of this item have performed more than 20 procedures in one day, according to Medicare Australia data. Not bad work if you can get it, but very poor public policy! The same lack of rigour in reviewing items also applies to gastroenterology and cardiology. While most gastroenterologists and cardiologists practise ethically, there are a few practitioners whose repeated use of procedures and investigations is highly questionable in patients whose clinical condition appears not to warrant them. However, there is no one asking the questions. The Medicare Safety Net is one of the most poorly thought-through pieces of health legislation. Despite its laudable policy intent — to help those with severe and chronic disease afford the cost of modern medical care — its implementation has gaping holes. The open-ended nature of the Safety Net offers the minority of unscrupulous and greedy practitioners opportunities to exploit it. After the Safety Net was introduced, a small group of obstetricians raised their fees for antenatal care from around $3000 to nearly $10 000. Such use of the Safety Net was perfectly legal, thanks to sloppily drafted legislation. During my time as Director of Professional Services Review, the Safety Net was used in effect to subsidise cosmetic procedures such as surgery for “designer vaginas” at $5000–$6000 each. I knew that the DoHA was aware of such misuses of the Safety Net. However, there seem to be no politicians with the appetite to face the problem and rein in millions of dollars in potentially inappropriate payments. Another major concern of mine has been the quantity of prescription drugs, particularly narcotics and benzodiazepines, finding their way onto the street. These drugs are well controlled by the manufacturer and the supply chain to the pharmacy. The weak link is the doctor’s prescription pad. Throughout my term as Director of Professional Services Review, I saw extreme examples of drug prescriptions that were clearly being misused or dispensed for resale by patients. In one instance, a doctor was prescribing 100 ampoules of 30 mg of morphine every week to a young patient without an appropriate indication. The state pharmaceutical branches are underresourced to track the prescription of benzodiazepines. Medicare is unable to identify abnormal prescribing patterns because many benzodiazepines are supplied on a private prescription. It is cheaper for a patient on a federal government benefit to pay for one private prescription for 200 diazepam tablets (less than $20) than to pay for four subsidised prescriptions of 50 tablets. I found many instances where a practitioner had supplied a PBS prescription for 50 tablets and a private prescription for 200 tablets.5 It is not only the MBS and the PBS where maladministration occurs. On several occasions I came across significant cost-shifting between the states and the federal government. Medicare was being used to subsidise state health budgets. Private radiology and pathology services were used for public inpatients, Medicare benefits were used to fund staff specialist study tours and to buy essential equipment. This is against the provisions in the Council of Australian Governments National Health Care Agreement. When this was pointed out to officers in the DoHA, I was told not to say anything. There is significant wastage within the Medicare scheme, which is threatening our ability to maintain first world standards in health care delivery. Australians are fortunate that, in the main, we do have a motivated and ethical health workforce. However, many of our colleagues feel let down by a system that so often does not deliver a timely or cost-effective service with proper controls. Many doctors I have spoken to are disillusioned by the inappropriate claiming and practice they are aware of. They feel disempowered to be able to effect change in our current health system.6 It is time for a thorough review of the manner in which health care is delivered in Australia. Piecemeal policy changes and bandaids are no longer adequate. To be of any value, a major review needs bipartisan political support. However, so long as health policy is used to bludgeon the other side of politics, we will never have meaningful change.

Tony D Webber MB BS, FRACGP

Lack of transparency and reliance on statistics alone make doctors vulnerable The Professional Services Review (PSR) was established to investigate and manage situations where the Medicare system was being used inappropriately by doctors. Undoubtedly, the PSR’s activities have identified and addressed instances of doctors knowingly exploiting Medicare. However, over the past 5 years, an initial general disquiet about the increased effect of the PSR’s investigative system and processes on general practice grew into widespread concern among broad sections of the medical profession and others. The PSR committees were disbanded because they were not ratified by the Australian Medical Association (AMA), 39 cases under review were dropped, and a senate inquiry into the entire running of the PSR scheme was conducted. The inquiry resulted in the publication of seven recommendations for improvements in the system,1 with a review with all relevant stakeholders planned for 12 months later. A common recurrent complaint was Medicare’s focus on statistics, with less emphasis on other information provided. Medicare targeted the right-hand end of the bell curve, assuming this was where inappropriate practice occurred. The “vanilla GP” who held four standard consultations an hour was the Medicare epitome of a gold standard practitioner and was safe from audit. However, the further GPs steered away from this “standard” practice, the more they were at risk of being investigated by the PSR. There is no substantial evidence that statistical outliers represent a high-risk group, and yet the PSR has intensified its auditing activities among such doctors, increasing auditing from 1% to 4%.2 Surveys of the medical profession have revealed deep concerns with the system and processes of the PSR. The AMA posed the question: “Do you think the Medicare audit process has become too heavy handed?”, to which 88% of respondents (307) voted yes.3 The Medical Observer ran a survey that attracted over 200 replies. It showed that over 80% of respondents felt that Medicare and the PSR had not replied adequately to queries on the Medicare Benefits Schedule and less than 15% felt confident they would pass an audit on the Enhanced Primary Care item numbers.4 The specific concerns held by us and others are numerous. In our view, the operational processes of the PSR and the Medicare audit system appear to be non-transparent, with too much power in the hands of the PSR Director. There is a denial of natural justice, with a high conviction rate and pressure to accept “negotiated agreements”, with no practical appeal process. Fines imposed are large, running to between five and six figures. Preserving patient confidentiality during an audit seems to disadvantage the case of the doctor being audited. The PSR does not appear to respond to concerns raised in these areas, and this undermines community confidence in primary care. A particular problem is that Medicare and the PSR give little or no guidance to GPs on the approved use of item numbers in the Medicare schedule. They have tried to refer complex requests back to the AMA and Royal Australian College of General Practitioners,5 and will not give binding interpretations on the use of Medicare items. Their past rulings do not provide useful guidance. This puts GPs in an extremely vulnerable situation, being unable to reliably check their interpretation of Medicare item numbers, yet able to be severely punished for actions judged to be misdemeanours at a later date. Some of the submissions to the Senate inquiry6 show the heavy-handedness of the PSR, particularly in relation to procedures performed by GPs. Examples include a rural GP being required to pay back a substantial sum because he had not personally documented the wound dressings and vaccinations performed (a nurse had done the documentation), and the rejection of independent assessment that disagreed with the PSR when investigating a rural GP for computed tomography scan orders. The PSR investigated 200 records associated with a procedural rural GP who had been in practice for 26 years because of “statistical anomaly” in the number of pre-anaesthetic checks ordered, even though the local hospital generated all these requests. On this basis, the GP was found guilty of incomplete record keeping and misinterpretations of item numbers 723 and 2713. He decided to accept the settlement after trying to sort through the issue over 2 years, although he did not feel at any stage that he had done anything wrong. Despite his previously clear record and full cooperation, he was subsequently fined a substantial five-figure sum and his patients were banned from claiming item 36 from Medicare. The particular case of Dr Tisdall,7 whose disqualification from Medicare was publicised by the PSR, and who fought for 10 years to clear his name, only to die soon after the federal court granted him the right to have his case reviewed by a new committee, is well known in the medical community and in Kyabram where he worked. The Full Federal Court was highly critical of the way the PSR went about making its findings. They described it as making a “speculative assumption” and decisions “simply based upon inferences drawn from statistics”,7 echoing criticisms from medical groups. The PSR is not only the concern of the various medical organisations that have queried its operation. The Australian community are the losers when government bodies fail. This inquiry has given us all the opportunity to improve a system for the benefit of patients, the government and doctors alike. The PSR needs to work hard with all medical and community groups to regain trust and respect.

C Scott Masters FRACGP, FAFMM, DipMusMed · Malcolm I Watt

Opportunities to examine the relevance of health interventions in actual clinical scenarios need to be created Evidence-based medicine underpins high-quality health care.1 The use of evidence in the practice of medicine informs appropriate decision making, reduces variability in clinical practice and helps ensure improvement of patient outcomes. Most evidence relating to new knowledge is derived from randomised clinical trials.2,3 However, evidence from clinical trials necessarily involves small and very carefully selected populations with particular demographics and disease characteristics. Hence, the results of clinical trials are often not directly relevant to clinical reality. In addition, the scientific basis of “standard therapy” against which new interventions are compared has not necessarily been rigorously tested. Uncertainty about how best to use such new evidence versus the range of alternative options available in the “real world” may create variable practices and impair patient outcomes. Paradoxically, evidence from these trials is used by the Medical Services Advisory Committee and the Pharmaceutical Benefits Advisory Committee to make decisions about approval and reimbursement of health interventions. Furthermore, while there are obvious ways by which governments and health insurance funds can constrain the costs of new technology, new services and new drugs before their reimbursement, their capacity to influence the use of existing, funded services in a manner that improves the quality of care is limited. In this article, I outline why comparative effectiveness research — examining the applicability of marketed and/or approved products, services and technologies to clinical reality — is critical to the future of health care in Australia. Such research should be funded by the existing health portfolio, as it would not only help reduce clinical uncertainty but, in an era of increasing cost constraints, could improve the efficiency of health expenditure within the framework of existing funded services. Proposal for a new funding streamIt might be assumed that funding from the current National Health and Medical Research Council (NHMRC) competitive grants scheme is sufficient for gathering comparative effectiveness evidence. However, this scheme tends to be focused on innovation, track record and scientific merit, but comparative effectiveness research may not be seen to be as novel as research that seeks to redefine the boundaries of new knowledge. In the United States, a focus on comparative effectiveness research has emerged as a high priority of the current administration.4 Given the limited pool of funds available for medical research in Australia, I propose a new funding program that is ring-fenced for comparative effectiveness research but administered by the NHMRC, with applications assessed on the basis of scientific merit, innovation, improved health and patient outcomes, and cost offsets. The new funding stream should encourage research that: rigorously tests scientifically based variations in approved or standard health interventions that are publicly funded directly compares the relative roles of approved, publicly funded components of treatment algorithms. A separate funding stream dedicated to clinical research that tests standard health interventions would benefit the community and the government — it would provide a means of optimising the utility of previously funded and approved clinical programs. A simple example of the type of project that such funding might realise is the comparison of variations to approved chemotherapy regimens, most of which are derived from historical practice patterns. For instance, the Short Course Oncology Therapy (SCOT) trial — comparing 6 months of chemotherapy (standard care)5 to 3 months of chemotherapy6 for the adjuvant treatment of operable bowel cancer (to determine whether less chemotherapy is not only less toxic and costly but also equally efficacious) — is currently underway in Australia and Europe.7 In addition, research that compares the components of treatment algorithms — conducted within or across disciplines in relevant populations — would enable optimisation of existing health practices, many of which required no specific approval process to have been introduced into standard treatment algorithms. (Modifications to treatment algorithms are often funded by being absorbed into the Medicare Benefits Schedule [MBS] and/or health insurance funds or by state-based programs.) For example, postoperative radiotherapy as adjuvant treatment for locally advanced gastric cancer is considered one standard of care in Australia and the US.8 Implementation of this modality required no formal approval process and the costs of adding radiotherapy to treatment algorithms were subsumed into the costs of standard care. However, because other studies suggest that perioperative chemotherapy (without radiotherapy) may suffice,9 a comparative effectiveness trial would result in considerable insights into the relative utility of the two approaches, with initial trial-related cost-savings providing substantial offset to the cost of the research. Furthermore, such research can do more than determine the role of radiotherapy in the treatment of operable gastric cancer. For example, in the Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma (TOPGEAR), the study design process required agreement on evidence-based surgical standards, standardised pathology examination and reporting, and standard chemotherapy regimens for this disease — none of which relate specifically to the experimental intervention.10 Hence, the research process resulted in clinician engagement in a change process that directly affected quality of care. By reducing variability in clinical practice outside the remit of the clinical trial, the research methodology will help ensure high-quality standards for patients, regardless of whether they are enrolled in the study. Similarly, the process of identifying and prioritising a potential question would help facilitate a change process inside and outside the specific research endeavour. The importance of such downstream effects is fundamental to understanding the potential impact of clinical research on the quality of the health system. Other types of more sophisticated research initiatives that test the interface between imaging, surgery and other techniques or practices, as well as the roles of pharmaceuticals, would undoubtedly emerge if the proposed funding stream were created. In so doing, such funding would enhance the capacity of Australian clinicians to promote the health care quality agenda in a cost-effective manner and across various components of the health system, such as the MBS and the Pharmaceutical Benefits Scheme (PBS). It would ensure that comparative effectiveness research initiatives do not have to compete against projects designed to develop new knowledge. A funding stream for comparative effectiveness research would invite research applications which are primarily designed to promote research into existing, funded health practices. Key criteria in funding decisions could include the likelihood of the research resulting in substantial impacts on the quality of patient care, in large numbers of patients, and the potential of the research to engage the broader health care community in a change process. The funding would not only help establish the relative roles of individual PBS- and MBS-funded interventions, but, from a broader viewpoint, would also show the government how clinical research represents a critical component of health care delivery. It would bring a quality focus to funding agencies concerned with the cost-effective delivery of medical services to the Australian community. Getting the new funding stream startedFunds from the existing health portfolio (MBS, PBS, etc) could be directed to a new NHMRC-administered funding stream of $100 million per annum for comparative effectiveness research. To start the program, the National Institute of Clinical Studies could facilitate development of a list of priority areas in three or more areas of health practice (eg, oncology, gastroenterology and rheumatology) by consultation with professional organisations, government agencies and consumer groups — similar to the list of priorities compiled by the US Institute of Medicine.11 This list could be used to pilot the funding program and could subsequently be extended to cover all areas of health practice. While the priorities within each health area could help inform the peer-review process, the call for applications should not discourage unanticipated ideas. In addition, the program should not be designed to provide a dedicated funding source for health economists — rather, it should encourage collaboration between practising clinicians from various disciplines, including experts in fields such as health economics and health system design. ConclusionA funding stream dedicated to comparative effectiveness research would improve health care quality, foster clinical practice research, and increase efficiency and effectiveness in the health system. It would also highlight the value of clinical research.

John R Zalcberg OAM, MB BS, PhD, FRACP

Three features are essential in designing the flexible funding payments and pay-for-performance elements Performance pay for doctors has been introduced in many countries, including the United Kingdom through the Quality and Outcomes Framework (QOF) and the United States through the patient-centred medical home model.1 The effectiveness of these models remains in question, although there is emerging evidence that these schemes can reduce hospital admissions.2-4 In Australia, the Coordinated Care for Diabetes Pilot (CCDP) begins in 2012.5 The key elements of the pilot (Box) are voluntary patient enrolment, a flexible payment for each diabetes patient to cover allied health services (among other things) and a pay-for-performance element. General practitioners will continue to be able to charge fee-for-service payments and claim diabetes-related payments from the Practice Incentives Program (PIP), but will no longer be able to claim the Chronic Disease Management Medicare Benefits Schedule (MBS) items for GP management plans or team care arrangements.5 Doubts about the effectiveness of financial incentives are raised, not only by poor design of evaluations, but also by poor design of funding models. Careful design, based on theory and empirical evidence, is essential in designing interventions to change professional behaviour.6,7 This helps to ensure that the intervention is likely to be effective, and that unintended and undesirable consequences of incentives are minimised. Our aim in this article is to propose three essential features of the flexible payment-per-patient and the pay-for-performance elements of the new CCDP.8,9 Rewarding improvements in quality of careAn objective of the CCDP is that incentive payments will be paid for: . . . the delivery of patient-centred care in accordance with best practice management guidelines for diabetes, and for achieving improvements in patients’ health against specific indicators.5 Payment should be made for improvements in the quality of care, which requires measuring changes in quality over time. Previous schemes have made payments for the achievement of a level of quality, often based on a relatively high threshold, rather than for an improvement in quality. Using thresholds may not lead to changes in behaviour because: (i) doctors in practices with already high levels of quality of care can claim the highest threshold payment without changing their behaviour; (ii) there are no incentives to go beyond the threshold, and (iii) doctors in practices with low levels of quality of care have little incentive to reach a high threshold, as they perceive the costs to be greater than the financial reward.10 One option is to reward improvements in quality between two time points, and set successive thresholds close together, say at 5% intervals.8 This would encourage those with low baseline levels of quality to improve the quality of their care. Furthermore, economic theory would predict that behaviour is only likely to change if the level of the payment is at least equal to the costs of improving the quality of care. These costs will vary across practices depending on their baseline level of quality and the complexity of the health problems of their patients.3 Allowing payments to vary in line with these cost variations would lead to a potentially more effective intervention. The costs of improving quality of care from 10% to 15% are likely to be lower than those of improving from 90% to 95%. Practices that already attain high standards of care find it difficult and costly to improve further and would not be able to claim an improvement payment. Thus, an element of performance pay should recognise the high performance levels already achieved. The “improvement” payment should be higher than the “achievement” payment, or there would be little incentive for practices to improve their quality of care. Avoiding “cream-skimming” and sharing financial riskA fixed payment per patient gives GPs an incentive to minimise costs, as any surplus from the budget can be kept as personal income or reinvested in patient care, and any deficits are borne by the provider.11 This is good for governments, who want to control costs and ensure costs are predictable, because it shifts the financial risk to GPs. However, if this risk is perceived to be too high, GPs may choose not to participate in the scheme or to enrol only “healthy” patients, so a careful balance needs to be struck between risk-sharing and the strength of incentives. The incentives to minimise costs and “cream-skim” are already ameliorated to some extent in the proposed CCDP. GPs can still claim standard MBS items and PIP payments for their patients with diabetes. Total revenue per patient will vary according to the number of visits made per year, and the length of each visit, which partly reflects complexity. However, this may not cover intensity in terms of the use of other resources in the practice, such as practice nurses or the costs of employing allied health professionals. One option is to “risk-adjust” fixed and performance payments, so that higher payments are made to practices with patients with higher needs or more complex health problems than the average. There is much international literature on this subject, including on the use of risk adjustment in the design of the patient-centred medical home pilots in the US.12 Risk adjustment requires data on the primary care costs of diabetes care for all patients and how this varies according to patients’ characteristics. Unfortunately, there are no routinely available data, and very little information on the use of allied health services by patients with diabetes and the associated costs.13,14 Primary care and hospital data would need to be linked to obtain adequate measures of patients’ severity of illness and diabetes complications.14 It is doubtful whether adequate risk adjustment can be developed and implemented in time for the pilot. However, given continued access to MBS and PIP payments, the additional level of risk for practices under the new scheme may not be high, although this will vary across practices. Avoiding exception reportingA further way that cream-skimming can take place for enrolled patients is exception reporting.15,16 Paying for the proportion of patients who achieve a certain target means that payments are based on a ratio, with the numerator equal to the number of patients reaching the target and the denominator equal to the number of patients in the population. Exception reporting occurs when practices exclude patients from the denominator, thus increasing measured performance and earning income, while not improving quality. For example, in the first year of the UK Quality and Outcomes Framework, a median of 5.4% (range, 0–40%) of practices used exception reporting for patients with diabetes. This translated into median gains of between £1700 and £15 000 per practice.15 One way to avoid exception reporting is to make payments based on the numerator only — that is, on the number of patients whose quality of care improves from one period to the next. This would involve a payment for each patient achieving a desired change in performance. Payments can only be increased from one time period to the next if the number of patients achieving a target, or whose quality of care improves, increases. ConclusionThe design of the new payment system in the CCDP should attempt to maximise the impact of the incentives on quality of care while also ensuring an “appropriate” sharing of financial risk with providers, in addition to minimising any unintended consequences, such as exception reporting and cream-skimming. This will partly depend on the validity and reliability of quality indicators, but experience from the Australian Primary Care Collaboratives Program suggests that such data can be extracted from practices. The balance of additional revenue between the flexible payments and performance-pay elements is also crucial, and can influence behaviour as well as costs. Careful design of incentive schemes is essential for their success. Current and new mix of payments for patients with diabetes under the Coordinated Care for Diabetes Pilot (CCDP) Payments Current mix New mix of payments in the CCDP*† 1. Fees for professional attendances For each visit, general practitioners can charge patients what the market will bear, and patients claim (often via their GP) a fixed rebate determined by the MBS. No change‡ 2. Practice Incentives Program Practices can claim payments for patients with diabetes within the PIP (the diabetes sign-on payment, the diabetes service incentive payment for completing a three-visit cycle of care, and the outcomes payment for each diabetes patient if the practice has completed cycles of care for at least 20% of their patients with diabetes). Practices in rural areas (RRMA 3–7) receive a loading on all PIP payments (including diabetes payments) of between 15% and 50%. No change 3. Fees for GP management plans and team care arrangements GPs can claim under MBS items 721 (development of a GPMP), 723 (development of TCA) or 732 (review of a GPMP or TCA). These are fees for each visit (so standard professional attendance fees cannot be claimed), with one GPMP or TCA claim allowed in 12 months (with some exceptions) and one review claim once every 3 months. Patients being managed under the chronic disease management items may be eligible for: allied health services (MBS items 10950–10970); and/or allied health group services (MBS items 81100–81125); and/or dental services (MBS items 85011–87777). There are restrictions on claiming both SIPs and GPMP/TCA/review payments. Practices can no longer claim these fees 4. Flexible funding None A single payment per enrolled patient per year 5. Pay for performance See PIP diabetes outcome payment for completion of cycles of care above. Payments related to improvements in quality of care — to be designed GPMP = GP management plan. MBS = Medicare Benefits Schedule. PIP = Practice Incentives Program. RRMA = Rural, Remote and Metropolitan Areas classification. SIPs = service incentive payments. TCA = team care arrangements. * There are other indirect funding sources for the care of patients with diabetes, including funding for practice nurses, which changed in late 2011 from practice nurse MBS items and payments under the PIP scheme, to fixed subsidies for practice nurse and allied health salaries under the Practice Nurse Incentive Program (http://www.medicareaustralia.gov.au/provider/incentives/pnip.jsp). † The levels of payments are to be determined as part of the implementation of the CCDP. ‡ To the extent that the scheme leads to more visits by patients with diabetes, this will also increase costs to the MBS.

Anthony Scott BA(Hons), MSc, PhD · Mark F Harris MB BS, FRACGP, MD

Australia’s Medicare Locals are in a formative period, and any comparison so far has focused on the United Kingdom The Australian and Canadian health systems share many similarities; one author has described them as “children of a common mother”.1 The fundamentals of the provision of primary care in both countries are the same: the overwhelming majority of “general practitioners” in Australia and “family physicians” in Canada work in independent practices, billing “Medicare” on a fee-for-service basis. The structure of family practice is similar, with a mix of solo and multiphysician practices. In Alberta, patients are not required to register with a single practice, but many family practices are not accepting new patients, and so registration with a practice is universally seen as desirable. There is no financial penalty (on the patient or the practice) for patients seeing a physician outside the practice in which they are registered. There are some differences; most notably that health care in Canada is essentially a provincial responsibility operating within overall parameters set by the Canada Health Act, and that “extra-billing” (billing above the schedule fee) is prohibited. The health systems in both countries face similar challenges in meeting the needs of primary health care: improving access, especially in rural and remote areas; better managing chronic disease; developing more effective links between primary care and hospital practice; and working out how to foster multidisciplinary teams. Alberta’s answer to these challenges has been to develop Primary Care Networks (PCNs), which may provide useful lessons for the establishment of Medicare Locals in Australia. Alberta is one of Canada’s western prairie provinces, with a population of 3.7 million, covering a geographic area about three-quarters the size of New South Wales. In 2009, Alberta had 113 family physicians per 100 000 population (4187 family physicians).2 The first PCN was established as part of the funding agreement between the province and the Alberta Medical Association in 2005. There are currently 39 PCNs in Alberta, and about 75% of family physicians work in practices that are members of PCNs.3 How PCNs functionPCNs are organisations of practices — the PCN itself does not enrol patients and does not run the practices. PCNs are eligible for a capitation payment of $50 per patient (for the purposes of this comparison, the Australian dollar can be assumed to be on a par with the Canadian dollar). PCNs are required to submit a “business plan” to Alberta Health Services (the provincial provider organisation responsible for the flow of funds to the PCNs) about how the capitation funding would be spent. Considerable flexibility is permitted in the structure and content of business plans, which allows for local variation in priority setting. PCNs range in size in terms of both the number of physicians linked to them and the number of patients served. PCNs in rural areas are smaller on both dimensions. PCN governance reflects both physician autonomy and the need for accountability to the funders (Alberta Health Services, and the relevant government department, Alberta Health and Wellness), reflected in two decision-making fora: a physicians’ board (known colloquially as the “Little Board”) and a PCN board (“Big Board”) with representatives of the funding organisations. The Big Board thus provides a direct link between the PCN and senior local Alberta Health Services leaders who are responsible for wider health issues. The PCN budget is derived from the capitation payments used to cover administrative costs of the initiative, which include employing an executive director responsible to the Little Board, employing allied health or mental health staff (often based in individual practices), and providing other support functions (eg, supplying comparative data). Evaluation of PCNsStakeholders see collaboration as the principal benefit of PCNs, and the provision of improved access to allied health care as one of their greatest strengths. “Collaboration” is used broadly here, to refer not simply to relationships between physicians and allied health professionals but also to relationships between physicians and the rest of the health system. In recent interviews with family physicians involved in PCNs in Alberta, conducted by one of us (A S, as part of a medical student placement), one physician stated that, “The PCN initiative has saved primary health care in Alberta”. Another, who holds positions on both the Little and Big Boards of a larger PCN, stated: Of the most important things which the PCN has achieved for our province, the first would be the re-involvement of family physicians with the health system, since, before this, they had been somewhat isolated; and the second [would be] better use of the full extent of capabilities and intelligences on offer from allied health professionals. There are disadvantages of the current PCN arrangements, including a lack of clarity with regard to general PCN direction, which stems from the autonomy in setting priorities granted to PCNs to allow maximum flexibility in responding to local needs. What can PCNs offer Medicare Locals?Strengthening primary care has been a catchcry of health reform efforts around the world for decades. The most recent Australian example is the report of the National Health and Hospitals Reform Commission.3 However, primary care is complex and reform is hard to achieve. One strategy has been to attempt to strengthen primary care by developing a stronger organisational base for it — initially, in Australia, through Divisions of General Practice,4,5 and more recently, through Medicare Locals.6 Divisions have been successful on a number of dimensions,7 although the administrative arrangements at both national8 and local levels9 have not been perfect. Arrangements for Medicare Locals are still evolving, and their evolution could benefit from taking note of similar strategies in other countries. Alberta’s PCNs have something to offer here as they have proven themselves to be a vital part of continued access to primary health care in the province. Although the Canadian and Australian health care systems are similar, they are not identical. Some aspects that may be portable are: Capitation funding — means that PCNs know how much they can expect and can plan accordingly. Depending on their size, PCNs receive up to $15 million per annum to be distributed in line with business plans. A dual board system — provides a compromise between physician autonomy in management of the PCN while allowing delegation of some decisions to the physician group. It has some parallels to the German approach of management and supervisory boards.10 An evolutionary approach — incorporating a slow phase-in means the system is not being imposed on any physician or practice and allows skeptics to evaluate the benefits of local cooperation. The first PCN was established more than 5 years ago, but some practices have not yet linked up to a PCN, despite the financial incentives. Alberta appears to have invented a wheel for primary care that is supported by family physicians. Australia could learn from this example without needing to totally reinvent it.

Andrew Suchowersky BMedSci(Hons) · Oksana Suchowersky MD, FRCPC, FCCMG · Stephen J Duckett PhD, DSc, FASSA

Major reform plus targeted strategies have the potential to provide relief Underpinning recent global health initiatives, including the Millennium Development Goals and the United Nations’ High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, has been recognition of the links between illness, disability, poverty and economic development. In Australia, the economic effects of illness, particularly long-term illness and disability, are often overlooked or examined exclusively in terms of the consequences for government budgets and the economy. While such analyses may be effective in alerting policymakers to the scale of particular epidemics, they provide little indication of the direct impact of illness on the wellbeing of those in the community. To do this, the unit of analysis needs to be shifted from the macro economy to individuals and households. The existence of universal publicly funded health care and social security arrangements has possibly encouraged complacency among researchers and policymakers about tackling this issue. However, there is emerging evidence in Australia that chronic illness and disability are associated with serious levels of economic hardship and that such hardship affects health behaviour1-3 — thereby completing a cycle in which poor health leads to poverty, which then leads to poor health. The economic consequences in question include not only the out-of-pocket costs of medical treatment, but also the costs of self-management (eg, home modifications, transport and paid care) and loss of income for patients and carers.1,3,4 As a result, those of low socioeconomic status are at greater risk of experiencing illness and disability and are more vulnerable to the consequences. Out-of-pocket costsThe most direct manner in which the economic impact of illness is felt is through the out-of-pocket costs of care. In Australia, despite a free public hospital system and universal social health insurance coverage through Medicare, levels of out-of-pocket payments are high by international, high-income country standards. In a recent Commonwealth Fund survey of 11 high-income countries, the incidence of out-of-pocket spending exceeding US$1000 in the previous year among individual respondents was 21% in Australia — behind only the United States (35%) and Switzerland (25%), and well above countries such as the United Kingdom (1%), France (4%) and New Zealand (7%).5 In 2009, out-of-pocket spending as a proportion of total health expenditure was 18.2% in Australia — above the Organisation for Economic Cooperation and Development (OECD) median of 15.8% (Box 1).6 This proportion has remained steady in Australia, not varying much from the 1999 value of 19.9%, and seems unlikely to change given one of the recommendations of the National Health and Hospitals Reform Commission: “We want to see the overall balance of spending through taxation, private health insurance, and out-of-pocket contribution maintained over the next decade.”7 It is hard to see any compelling fiscal justification for such a policy when a comparison across OECD countries indicates that public spending on health in Australia in 2009 (5.8% of gross domestic product) was well below the OECD median (6.9%).6 What are the implications of these costs?The picture emerging from recent studies in Australia is that major burdens are being imposed on particular patient populations by high out-of-pocket costs.1-4 For example, in a study of patients with chronic obstructive pulmonary disease (COPD), 46% of patients experienced an incidence of catastrophic health care spending — defined as out-of-pocket costs exceeding 10% of income for the period studied.1 The main out-of-pocket costs incurred by these patients are shown in Box 2. In general, evidence suggests that the high burden of out-of-pocket costs tends to be skewed toward those with comorbidity1 and those with more severe illness.8,9 However, the hardship related to such burden tends to be most pronounced in people who have retired1 and those of low socioeconomic status,1 and there is little evidence of concession or insurance status providing significant protection.1,10 In addition, substantial costs incurred by patients are often not for health care but for home modifications, social support and transport.1,3,4,10 Significantly, increasing levels of out-of-pocket costs associated with copayments for PBS-listed medications have been found to be associated with reduced rates of prescriptions being filled.2 Such findings are supported by evidence from a qualitative study of patients with chronic illness in western Sydney and the Australian Capital Territory; lack of affordability of medical treatment, and thus impaired ability to self-manage, was a major aspect of economic hardship for these patients.3 Putting these findings into context, over the past 10 years the out-of-pocket burden associated with both MBS-listed medical services and PBS-listed medications has increased substantially (by 4.2% and 6.7% per year respectively).6 The concern is that these rising levels of copayment will adversely affect compliance, particularly in patients who require long-term treatment. Indirect costsIllness and disability also affect household economic circumstances through their effect on employment. In 2006, 33% of 18–64-year-olds who reported specific limitations or restrictions lived in households in the lowest income quintile, compared with 10% of those without such impairment.11 This pattern is further pronounced in individuals with intellectual disability and severe or profound disability, with 40% and 36% of people in these groups, respectively, living in the lowest income quintile households.11 This impact extends to informal carers, who often leave paid employment to care for a sick family member. While there are income support programs in place to assist those with long-term illness and their carers, often these barely cover living and medical expenses.3 Nevertheless, the prospect of losing income support payments and concessional status as a result of resuming employment can create a welfare trap for patients and carers, particularly those in low-income occupational groups. Financial stress and illness-related povertyIn Australia in 2009, 28 665 individuals became bankrupt, of whom 11% cited ill health or absence of health insurance as the primary reason.12 While illness-induced bankruptcy is not as large a problem in Australia as it is elsewhere (such as the US, where it caused 62% of bankruptcies in 200713), significant numbers of Australians are catastrophically affected by illness. In addition, disability has been found to be associated with more acute measures of economic hardship, such as financial stress based on an individual’s ability to raise a sum of money for something important. The Australian Institute of Health and Welfare (AIHW) has found that individuals with specific limitations or restrictions, when compared with those without impairment, report over double the rate of being unable to raise $2000 (26% v 11%).11 Another criterion for assessing financial stress is the inability to make necessary household payments. According to the AIHW, 34% of 18–64-year-olds with specific limitations or restrictions reported at least one such incident in the previous 12 months, compared with 18% of those without impairment.11 One study which adopted this broader perspective of examining the economic impact of illness and disability on households found that, in patients with COPD in western Sydney, 78% reported at least one instance of being unable to make necessary payments in the previous 12 months or, to do so, needed help, sold assets, moved house or borrowed money.1 Similarly, in individuals participating in the Household, Income and Labour Dynamics in Australia (HILDA) Survey, a population-based longitudinal survey, such incidences of financial stress were found to be strongly associated with disability, poor physical function and poor mental health.14 What can be done?The studies conducted in Australia indicate that health-related economic hardship tends to disproportionately affect specific patient populations, largely due to costs that are conventionally treated as being unrelated to the health sector. In the absence of comprehensive evidence, it is only possible to gather findings from a patchwork of unrelated studies. Priority should therefore be given to developing a consistent approach that records the specific costs to individuals and their households associated with illness and identifies the impact of these costs on health behaviour and wellbeing. The available evidence indicates that the out-of-pocket costs of treatment and self-management and loss of income from chronic illness and disability are associated with economic hardship, catastrophic health care spending and non-compliance with medical treatment. Major reform, such as the recently proposed National Disability Insurance Scheme (NDIS), has the potential to address hardship associated with illness and injury. However, meaningful improvement is also possible through small-scale targeted strategies. As household economic burden is skewed toward specific patient groups, effective remedies could include focused interventions such as income support and subsidies. These measures would identify and catch those individuals and households that currently fall through the cracks. They would also be unlikely to involve changes that distort current health care priorities or restructure the responsibilities of different government sectors. Furthermore, they could be implemented quickly. Ultimately, both broad-brush policies such as the NDIS and targeted support measures are needed to provide direct relief to individuals and households most at risk of illness- and disability-related economic hardship. 1 Out-of-pocket costs as a share of total health expenditure in OECD countries, 2009* OECD = Organisation for Economic Cooperation and Development. * Reproduced with permission from the Australian Institute of Health and Welfare.6 2 Main out-of-pocket costs associated with managing chronic obstructive pulmonary disease1 Home oxygen and medications Transport Medical consultations and tests Home care Medical equipment

Stephen Jan BEc, MEc, PhD · Beverley M Essue MPH · Stephen R Leeder BSc(Med), MD, PhD

Supply must meet demand to maintain our high standards of cancer care Recent years have witnessed significant progress in cancer treatment, with improved outcomes,1 treatment options, emergence of survivorship care, and acceptance of multidisciplinary care as the optimal care delivery method.2 All Australian states have cancer plans, and considerable funding has been committed to cancer control by state and federal governments. While cancer outcomes in Australia are excellent by world standards, cancer care providers and consumers are concerned about the ability of the oncology workforce to meet the growing demand, and the effect that shortages may have on the quality of care. The number of new cases of cancer continues to increase by about 3% per year because of increased population, improved longevity and increased detection rates. Over a decade, the increase amounts to nearly 40%.1 The expansion of cancer services has barely kept pace with the increased number of cases, and the number of training positions, while highly in demand, is not sufficient to address the need.3 This concern is illustrated by a recent major federal government investment into rural cancer centres of $560 million.4 The funding is subject to a partnership agreement with the states to ensure an adequate workforce (as well as other recurring costs) to deliver care in rural centres. With 20 facilities to be created or expanded with federal funding, and others developed with state support (10 additional facilities in South Australia alone), there can be only two potential strategies for workforce supply. One is to create new positions (unlikely to be successful, given the national and international shortages in the cancer workforce and no specific commitment of additional funding for that purpose); the other is to redistribute the existing workforce and optimise work practices to manage additional demands. It seems prudent to consider these possibilities in some depth, and we have done so using information from the recent workforce survey of the Medical Oncology Group of Australia (MOGA).5 Medical oncology is a key element of multidisciplinary cancer care, and is thus fundamental to services in the proposed rural expansion. It is estimated that about half of cancers require treatment with at least one course of systemic therapy.6 Medical oncologists (MOs) frequently supervise chemotherapy, targeted therapies, treatment with biological agents and hormonal therapy. They may be responsible for care coordination and provide supportive, palliative and follow-up care. The MOGA survey demonstrates that currently in Australia there is a significant shortage and uneven distribution of MOs that is unlikely to be addressed by the increase in training positions. Of even more concern is that the estimated chemotherapy utilisation rate (the proportion of new patients with cancer who receive chemotherapy at least once during their illness) appears to be less than half the recommended rate.5 There is no indication that MOs turn patients away (although the subject was not specifically covered in the survey), and it is likely that the low chemotherapy utilisation rate may reflect limited access to MOs or limited awareness about the value of medical oncological treatment among referring doctors. Increasing engagement of MOs with other doctors and development of rural centres may help solve these problems. But the concern remains that with the existing medical oncology workforce, we simply do not have the capacity to increase the chemotherapy utilisation rate. The federal government investment in infrastructure for rural cancer centres is one example of the challenges for the cancer workforce in general. The current workforce of 234 full-time equivalent (FTE) MOs will need to absorb the work demands of the additional 20 rural facilities. Even allowing an average of 0.5 FTE MOs per site, this would require an increase of 10 FTE MOs, which seems hard to achieve, given that 29 FTE MO positions are currently unfilled. Some patients who would be seen in the rural centres are currently seen in metropolitan facilities, so there will be some shift in workload, but there will also be a need to allow time to travel, especially in states where the population density is such that there is just not enough work for a resident MO. There will also be a cost associated with taking an MO out of the existing facility to provide care elsewhere. We do not claim that these figures are precise, but they illustrate the calculations that may be required and are yet to be presented. We hope that raising these issues may serve as a call to action, because without thoughtful strategies to increase the oncology workforce, the investment of $560 million may not reach its full potential. So what can be done? We argue that quite a lot can be achieved. The medical oncology profession is committed to promoting best practice and monitoring workload and current and future demand to deliver care with the highest quality and safety, as close as practicable to patients’ homes. MOs are open to innovation and welcome nurse practitioners, physician assistants and other innovative health care delivery strategies, including shared-care models, role redesigns and “e-health” solutions that can improve efficiency and access to care. Every effort should be made to reduce inefficient and unnecessary care; for example, use of chemotherapy when palliative care may be more appropriate, and MO management of patients who may be more appropriately followed up in general practices. The solutions need to be feasible, and consistent across the public and private (which currently has less access to innovative models of care delivery) sectors. The federal government has established two agencies with significant roles to play: Cancer Australia and Health Workforce Australia. These agencies and the profession must jointly address the challenges ahead in order to solve problems across jurisdictions — across state and federal boundaries, rural and metropolitan areas, the public and private sectors, government and training colleges and across professions. Just as we recognise that clinical care can best be delivered in a multidisciplinary setting, we need to start planning cancer care in the multidisciplinary setting. We know that work shortages described in medical oncology are similar to those in other disciplines, and addressing shortages in one area in isolation will not solve the problem; solutions must encompass the entire spectrum of cancer care professionals. Australia is unique internationally in having a strong professional multidisciplinary cancer organisation (the Clinical Oncological Society of Australia) that can engage cancer providers across disciplines. Now we need the jurisdictions to work with Cancer Australia and Health Workforce Australia in conjunction with the professional groups and consumers. We have seen the benefits of this approach already, in radiation oncology. The Radiation Oncology Reform Implementation Committee, under the auspices of the Australian Health Ministers’ Advisory Council, has driven significant improvements in delivery and staffing in Australia, and was another driving force for the regional cancer centre initiative. We need to apply similar processes to delivery of systemic anticancer therapies. We need to better define the problem. The MOGA survey is a good start, but points out one serious limitation: without national investment into robust data collection systems, we will not be able to plan effectively or monitor outcomes of interventions. The MOGA survey calls for a national cancer workforce plan that can provide projections and recommendations for the future. It takes 13 years to train an MO from the time of entry into medical school. To plan for the 40% growth in cancer incidence over the next 10 years, we need to invest in new training positions today, focusing not only on numbers of places but also on creating systems allowing people to work more efficiently and flexibly, so we not only attract them to the profession but retain them at peak performance. We need to agree as a society what standards of care we aspire to and what standards we can realistically deliver. How many patients can we reasonably expect an MO to see without risking burnout or dangerous errors occurring? We need to engage consumers in some difficult conversations on how we can provide the best care, not in the ideal setting, but in the reality of our limited (human) resources. Australia has one of the highest standards of cancer care in the world, but we can do even better with appropriate staffing, quality and distribution of our cancer care workforce. It is time to come together to start addressing the looming shortages before it is too late.

Bogda Koczwara MB BS, FRACP, MBioethics · Michael B Barton OAM, MB BS, FRANZCR · Euan T Walpole MB BS, FRACP · Peter Grimison MB BS(Hons), PhD, FRACP · Prunella L Blinman BMed, FRACP · Sally Crossing AM, BEc · Kay Francis BA(Hons), MA(Hons), MBA

Manufacturers will need to improve quad bike design to meet safety requirements Agriculture is internationally recognised as a hazardous industry. Despite a 44% reduction in non-intentional farm injury deaths in Australia over the past 15 years (of which machinery-related incidents are the predominant cause), considerable opportunities for prevention remain.1 Quad bikes and tractors are leading agents in these incidents. To date in 2011, there have been 16 farm-based and five off-farm quad bike deaths, plus eight tractor fatalities. These do not include the considerable number of injuries, which sometimes result in lifelong debilitating conditions. In tractors, rollover fatalities have decreased by 60% after the introduction of regulations requiring compulsory rollover protection structures.2 In agriculture, with its diverse hazards and working environments, good design is vital to improving health and safety. Regrettably, this has not been the case with quad bikes. Over the past 10 years in Australia, on average there have been 14 quad bike fatalities each year. About half of all fatalities have involved rollovers, which frequently cause death by asphyxiation and/or crush syndrome.3 Annual fatality figures of 600–800 in the same 10-year period in the United States illustrate the scope of this issue.4 Currently, there are about 220 000 operating quad bikes, each typically weighing 250–350 kg, in Australia, with annual sales exceeding 20 000 units. Given their use will grow, one would think that improving design to reduce rollover risks would be high on the agenda of the quad bike manufacturers. Think again! Independent engineers have seriously questioned the validity of quad bike industry simulation research, which disputes the benefits of protective devices. The results of industry modelling are at odds with published research on head and trunk injury, and provides little support for installing crush protection devices to protect riders. Even so, the industry data still indicate a net protective benefit of up to 29% for the one commercial crush protection device in Australia.3 Yet an industry representative has categorically stated that he does not “see any circumstance in which we would decide to fit such a device”.5 From 1 January 2012, the new national Model Work Health and Safety Regulations 2011 (http://safeworkaustralia.gov.au/AboutSafeWorkAustralia/WhatWeDo/Publications/Pages/Model-WHS-Regulations.aspx) will require that all “powered mobile plant” (including tractors, field machinery and quad bikes) must manage risk in accordance with the hierarchy of controls (Box), including risks of overturning. The quad bike industry continues to rely on training and helmets — low-order solutions in the hierarchy of controls — to minimise risks. Given the new regulations require these risks to be managed “so far as is reasonably practicable”,6 this is unlikely to be adequate. The potential for these regulations to have international ramifications in itself may be a factor contributing to the industry’s intransigence in fitting crush protection, particularly with the potential prospect of litigation. Inevitably, regulators who set an international precedent will face strident opposition from a multinational industry. The self-regulation tactics adopted by the industry in the US will also need to be circumvented, where the industry has influenced quad bike state laws by developing model state all-terrain vehicle safety legislation, which, unsurprisingly, does not feature crush protection.7 Without genuine solutions from manufacturers, regulators will have to drag an unwilling industry forward. History has shown that enforced regulation can kick-start design improvements that benefit both users and companies. Indeed, given the new regulations, it is questionable whether these vehicles meet safety requirements for use in an Australian workplace where overturns must be managed. Although mandating design improvements for safety in rollover incidents is critical, it is not a panacea. Clinicians have an important role in encouraging practices to reduce quad bike-related injuries (Box). The new regulations will allow a line in the sand to be drawn on how this situation is handled. While this is unlikely to be an easy process, the alternative of the continuing high burden that quad bike casualties place on communities is simply unacceptable. Hierarchy of control applied to use of quad bikes on farms

Tony G Lower PhD

Selective oestrogen receptor modulators effectively reduce breast cancer in women at moderate to high risk, so why aren’t they being discussed routinely? Using medication to prevent breast cancer in women at moderate and high risk is a cost-effective1 and immediately implementable strategy for reducing the burden of breast cancer in Australia. There is Level 1 (strong) evidence that selective oestrogen receptor modulators (SERMs) such as tamoxifen and raloxifene reduce breast cancer risk by up to 40% in these women.2 The absolute risk reduction depends on an individual’s risk factor profile. These agents are rarely prescribed in Australia for breast cancer prevention (for complex but potentially modifiable reasons3) even in women at high risk, although they are now endorsed in an Australian guide and in the American Society of Clinical Oncology practice guideline.2,4 We summarise the evidence and suggest ways to implement this intervention in Australia. Women at high risk of breast cancer have the most favourable risk–benefit ratio, and hence are the focus of this article, but consideration of use of SERMs for women at moderately increased risk is also appropriate. Who is at high risk?The average lifetime risk of breast cancer for an Australian woman is 1 in 9 or 11%. A very small proportion (< 1%) of Australian women have a mutation in a major breast cancer predisposition gene, such as BRCA1, BRCA2, p53 or PTEN, resulting in a high lifetime risk for breast cancer of up to 80%. A larger group has a strong family history of breast cancer but no documented gene mutation. These women have a lifetime risk of at least 30%. A history of some types of benign breast disease and higher mammographic density also increase a woman’s risk. Importantly, an individual’s risk changes with age.5 To aid clinicians, the National Breast and Ovarian Cancer Centre (NBOCC) has developed a risk assessment guide and the online Familial Risk Assessment — Breast and Ovarian Cancer (FRA-BOC) risk assessment tool (one of several available6), (http://canceraustralia.nbocc. org.au/fraboc/). “High risk” throughout this article includes category 3 of the NBOCC guide (Box 1). Efficacy of SERMs for prevention of invasive breast cancerSeveral large randomised controlled trials (RCTs), which included over 25 000 women with at least moderately increased risk, have demonstrated the efficacy of SERMs.7-10 These trials showed that 5 years of tamoxifen use at 20 mg daily reduces breast cancer risk by 40%.2 The absolute benefit is thus between 12% and 32% for a woman at high risk (as defined in the previous paragraph), depending on her underlying absolute risk of breast cancer. Raloxifene is about 75% as effective as tamoxifen in postmenopausal women,11 with an arguably better side effect profile. Raloxifene has not been tested in premenopausal women. Both medications reduce the incidence of hormone receptor-positive cancers. SERMs also reduce breast density, which may facilitate earlier mammographic diagnosis of hormone receptor negative cancers.12 The reduction in breast cancer incidence is maintained for at least 5 years after a patient discontinues tamoxifen.2,7 Although none of the RCTs was powered for a mortality end point, reduced breast cancer incidence translates to reduced physical and psychosocial morbidity and treatment cost savings,1 and is a worthwhile and clinically meaningful end point. Possible side effectsThe commonest side effects of SERMs are hot flushes, sweats and altered vaginal secretions. In the RCTs, 10%–12% more women using tamoxifen had vasomotor and vaginal symptoms than in the placebo group; however, no difference was found in the incidence of depression, weight gain or overall quality of life.13 For the minority of women who experience significant problems, the SERM can be discontinued. SERMs double the risk for deep vein thrombosis and thromboembolism during use. The absolute incidence is around 4 per 1000 women-years of use (0.4% per year).11 For premenopausal women, with their low background risk of deep vein thrombosis, the absolute risk is even smaller; around 0.1% per year10 (comparable to the excess risk of thrombotic events in women who take third-generation oral contraceptives).14 SERMs did not significantly increase the risk for coronary heart disease or stroke in prevention trials.15 Women who smoke or those with a previous history of thrombosis should probably not be offered SERMs for risk reduction. Other contra-indications are listed in Box 2. Tamoxifen is associated with an excess risk of endometrial carcinoma of 0.25%–0.4% per year during use in postmenopausal women. The risk is not significantly increased in premenopausal women.10 Raloxifene does not increase the risk of endometrial cancer.11 Tamoxifen is a potential teratogen, and therefore is not appropriate for women planning pregnancy in the treatment period or women not using reliable contraception. There is a modest increase in the risk of cataracts (relative risk, 1.14; 95% CI, 1.01–1.29) in women taking tamoxifen.10 Bone density and fracture rates are improved by 5 years of SERM use after menopause,15 and raloxifene is currently prescribed for this indication. Current uptake of preventive SERMsBefore September 2010, the Australian NBOCC guide suggested consideration of prevention trials but made no recommendations about off-trial SERM use. Current use of SERMs preventively in Australia is very low. Of 3788 women at high risk of breast cancer enrolled in a national cohort study (kConFab), fewer than 3% have used SERMs for prevention, and only 0.3% have done so while not enrolled in a clinical trial.16 Alternatives to SERMsThe main alternatives to SERMs are screening and, for women at high risk, risk-reducing surgery (Box 3). Only 5% of women at high risk in the kConFab cohort have undergone risk-reducing surgery, and the vast majority are not using any preventive strategy.16,17 Annual breast imaging for early detection is suggested but does not reduce risk and is not proven to decrease mortality in premenopausal women at high risk.18 Aromatase inhibitors are under investigation for breast cancer prevention, with early results showing a benefit for exemestane,19 but longer term follow-up is needed, and use outside a clinical trial is not recommended in any guide. The International Breast Cancer Intervention Study (IBIS II), an RCT of anastrozole versus placebo, is currently recruiting participants in Australia. Barriers to uptakeThere are multiple potentially reversible barriers to recommendation of SERMs by clinicians and acceptance by women (Box 4). Some of these have recently been addressed, notably by revision of the NBOCC guide, which now suggests consideration of SERMs for women with moderate or high risk of breast cancer (Box 3). Referring to preventive SERMS as “chemoprevention” creates confusion with chemotherapy and results in negative attitudes towards this strategy.20 The consumer group Breast Cancer Network Australia recommends use of the term “risk-reducing medication” (Gerda Evans, Advocate, Breast Cancer Network Australia, personal communication, 24 August 2011). Tamoxifen is often imprecisely referred to as “hormone therapy”, potentially reducing its acceptance in a community aware of the risks of cancer with long-term hormone replacement therapy.21 Concern about side effects is common. Descriptions of relative rather than absolute risks of side effects can result in overestimation of the risk of rare side effects. This limits patient acceptance, as does lack of precision in estimating the magnitude of absolute benefit, which depends on multiple individual factors. Several contributors to the reluctance of doctors to prescribe SERMs are documented, and include a previous lack of endorsement of SERMs for risk reduction in guidelines, deficiencies in knowledge of risk assessment or patient selection, and time constraints.3 The new NBOCC guide and FRA-BOC risk assessment tool do much to address these issues. Australian doctors identify the lack of a Pharmaceutical Benefits Scheme subsidy as a barrier to prescribing, but tamoxifen and raloxifene are relatively inexpensive (less than $1 and $2.50 per day respectively) and likely to be within the means of most patients. Raloxifene is registered with the Therapeutic Goods Administration for the indication of breast cancer prevention in women at high risk, but registration for this indication has never been sought for tamoxifen and, as an off-patent drug, there is little incentive for pharmaceutical companies to champion its listing. This lack of registration for breast cancer prevention is cited as another barrier to prescription of tamoxifen. Nevertheless, off-label prescribing of tamoxifen is an appropriate approach because high-quality evidence exists to support its use.22 Tamoxifen and raloxifene are approved by the Food and Drug Administration for primary prevention of breast cancer in the United States. Who should prescribe?A minority of Australian women at increased risk of breast cancer regularly attend a risk management clinic where SERMs can be prescribed and monitored,23 but most require an alternative model of care. General practitioners and breast surgeons are ideally placed to identify women at increased risk and discuss, prescribe and monitor risk-reducing medication. GPs have a central role in prescribing for prevention of other conditions such as cardiovascular disease, and are a trusted source of prevention advice and management. Information is lacking on why Australian GPs and breast surgeons are not currently prescribing SERMs for prevention, but it is likely that they would benefit from further education and better tools to identify women at high risk. Tools such as the FRA-BOC risk assessor and the IBIS risk calculator (http://www.ems-trials.org/riskevaluator/) allow rapid assessment of breast cancer risk, but it remains difficult to quantitatively assess an individual woman’s absolute risk of side effects due to SERMs. Cancer Australia has developed a fact sheet which provides helpful information about contraindications and practicalities of prescribing. An evidence-based, online decision aid that enables personalised risk–benefit assessment is urgently needed. ConclusionAustralian women at moderate and high risk for breast cancer are not routinely offered SERMs, a proven preventive strategy. We hope that the recent update of the NBOCC guide including a suggestion for consideration of SERM use, along with the easy availability of online risk assessment tools, will increase preventive SERM use. Improved education and decision support for clinicians may help reduce the controversy surrounding the use of SERMs for breast cancer prevention and ultimately reduce breast cancer incidence. 1 National Breast and Ovarian Cancer Centre* breast cancer risk, by family cancer history criteria Category 2 (moderate risk for breast cancer) criteria Category 3 (potentially high risk for breast cancer) criteria One first-degree relative diagnosed with breast cancer before age 50 years; without the additional features of the high-risk group or Two first-degree relatives on the same side of the family diagnosed with breast cancer; without the additional features of the high-risk group or Two second-degree relatives on the same side of the family diagnosed with breast cancer, at least one before age 50 years; without the additional features of the high-risk group Two first- or second-degree relatives from the same side of the family diagnosed with breast or ovarian cancer plus one or more of the following (the same side of the family): additional relative(s) with breast or ovarian cancer breast cancer diagnosed before age 40 years bilateral breast cancer breast and ovarian cancer in the same woman Ashkenazi Jewish ancestry breast cancer in a male relative or Breast cancer in a first- or second-degree relative aged 45 years or less, plus sarcoma in another first- or second-degree relative aged 45 years or less, from the same side of the family or Member of a family in which a high-risk breast cancer gene mutation has been established, unless tested and found not to carry the family mutation or For women who are potentially at high risk of ovarian cancer, refer to http://www.nbocc.org.au/view-document-details/bog-advice-about-familial-aspects-of-breast-cancer-and-epithelial-ovarian-cancer * In July 2011, the National Breast and Ovarian Cancer Centre amalgamated with Cancer Australia to form a single national agency, Cancer Australia. 2 Contraindications to use of selective oestrogen receptor modulators in breast cancer risk reduction Pregnancy or absence of reliable non-hormonal contraception in a woman of childbearing potential History of endometrial hyperplasia Previous venous thromboembolic disease or inherited thrombophilia Patient is currently smoking Concomitant use of exogenous hormones (hormone replacement therapy or oral contraceptive pill) Premenopausal women should not be prescribed raloxifene 3 National Breast and Ovarian Cancer Centre management recommendations for women at moderate and high risk of breast cancer Preventive approach Moderate risk High risk Screening Annual mammogram from age 40 years if a first-degree relative younger than 50 years diagnosed with breast cancer Annual mammogram not recommended for women with one relative diagnosed with breast cancer after 50 years Regular clinical breast examination Annual breast imaging with mammography, magnetic resonance imaging or ultrasound Medical prevention For women over 35 years, consider tamoxifen or raloxifene to reduce risk Requires careful assessment of risks and benefits by an experienced medical professional Consider tamoxifen or raloxifene to reduce risk Risk-reduction surgery Discuss risk-reduction surgery Further assessment Consider referral to a family cancer clinic Advise referral to a family cancer clinic for risk assessment, possible genetic testing and management plan General recommendations Discuss modifiable risk factors* Encourage women’s awareness of normal look and feel of their breasts and reporting of changes Investigate symptoms using the triple test Discuss possible participation in a clinical trial for risk reduction or prevention† Discuss modifiable risk factors* Encourage women’s awareness of normal look and feel of their breasts and reporting of changes Investigate symptoms using the triple test Discuss possible participation in a clinical trial for risk reduction or prevention† * http://canceraustralia.nbocc.org.au/view-document-details/rfrw-breast-cancer-risk-factors-a-review-of-the-evidence. † For current clinical trials see http://www.australiancancertrials.gov.au, http://www.anzctr.org.au and http://www.anzbctg.org.au. 4 Barriers to uptake of medication to prevent breast cancer Barriers for prescribers Lack of Pharmaceutical Benefits Scheme subsidy Reluctance to prescribe off-label Many potential prescribers (eg, geneticists) do not follow up patients long term Potential prescribers feel inadequately resourced Perceived lack of endorsement (recently addressed in updated National Breast and Ovarian Cancer Centre guide) Barriers for women at risk Negative attitudes generated by use of words “chemoprevention” or “hormone therapy” Confusion between relative and absolute risks of side effects Fear of vasomotor side effects Inaccurate self-estimates of breast cancer risk Cost concerns

Sandra L Harvey BAppSc, MB BS, FRACP · Jane E Francis MA, MPH · Amanda J McBride MB BS · James F Bishop MD, MMed, MB BS · Kelly-Anne Phillips MB BS(Hons), MD, FRACP

We need an urgent review of medicines labelling in Australia and New Zealand Almost 25% of patients admitted to hospital a decade ago received inappropriately prescribed medicines.1 As 40% of patients aged over 70 years receive more than five medicines, they are increasingly vulnerable to medication errors.1 Increasing brand substitution due to the proliferation of generic medicines adds to the potential for consumer and practitioner confusion and the likelihood of medication misadventure.2 Clinical scenario: Ms M J, aged 79 years, when questioned about her current prescribed medicines by her physician during an initial consultation, produced a list that included an angiotensin-converting enzyme (ACE) inhibitor, a selective serotonin reuptake inhibitor, a benzodiazepine, an anticonvulsant, and both Oroxine 100 μg and Eutroxsig 100 μg daily; the latter two preparations are both thyroxine sodium. Brand substitu-tion by her pharmacist was confirmed as the cause. There is anecdotal evidence that the progressive increase in innovator (new medicines) and especially generic brand names is associated with inappropriate prescribing and medicine use.3,4 Furthermore, the widespread practice of brand substitution by pharmacists, in which one brand (innovator or generic) is substituted for another, increases confusion, particularly among consumers but also among doctors, nurses and pharmacists. In some cases, such as the above, it can lead to duplicate prescriptions of a medicine.5 Juliet’s reflection in Romeo and Juliet, “What’s in a name? That which we call a rose by any other name would smell as sweet”, may be true for flowers, but clearly not pharmaceuticals. Brand name proliferationAlthough the increasing number of pharmaceuticals has obvious health benefits, the potential for confusion resulting from the thousands of associated brand names requires action. Some prescribers and consumers find brand names more convenient than generic names, but the frequent absence of any relationship between a brand name and the active ingredient or the condition being treated is problematic. Antihypertensive agents illustrate the breadth of brand proliferation. Eight different ACE inhibitors are used in Australia, excluding combinations, whereas 81 brands have Therapeutic Goods Administration (TGA) approval (Box). Enalapril maleate, which has been available for decades, is available in 12 brands, and only six of these use the active ingredient as part of their brand name. While prescribers and dispensers will recognise the active ingredient in these names, many consumers might consider Enalapril-DP and Enalapril Winthrop to be different, and would not necessarily know that Auspril and Alphapril are the same. The proliferation of brands today contrasts sharply with the situation 20 years ago, when only three ACE inhibitor preparations, Capoten, Amprace and Renitec — representing two individual medicines — were available. Even a relatively new generic medicine such as amlodipine is now available in 10 brands, excluding combinations, and many prescribers would be challenged to define the active ingredient of Ozlodip (amlodipine) from its name. Newer brand names of other antihypertensive agents such as Deralin (propranolol), Fibsol (lisinopril), Tryzan (ramipril) and Nyefax (nifedipine) clearly do not contribute to the quality use of medicines. Although there may be marketing sense behind the choice of a catchy name for a new product, generic brands are rarely marketed to prescribers, and pharmacists’ decisions are more likely to be based on cost, not persuasive advertising. Consequently, as a first step, companies that use the active ingredient name within their brand name should be supported. Some companies market the same active ingredient under different brand names but use identical tablet colours and shapes, which may limit brand confusion. However, it is worth noting that Oroxine and Eutroxsig are concomitantly used in the clinical scenario above, and are manufactured by the same company. Consequences of labelling confusionConsumer confusion and adherence problems are related not only to names but also shape, colour, taste, packaging, printing and excipients. The Second national report on patient safety noted that “look-alike or sound-alike” medicine names cause errors and system failures in hospitals and the community.7 The United States Institute for Safe Medication Practices reported that about 25% of serious complications relating to use of medicines resulted from name confusion, with another 25% due to labelling and packaging confusion.8 Another recent US study demonstrated poor emergency department patient knowledge concerning paracetamol in over-the-counter and prescription analgesics: for example, 49% of patients did not know that Tylenol, a commonly used US analgesic, contained paracetamol.9 Lack of knowledge about the paracetamol content of commonly used over-the-counter preparations (including combination products) given to children by parents and carers has resulted in many cases of paracetamol overdose and toxicity in young children.10 Generic brand substitutionAlready a common occurrence in hospitals, generic brand substitution is increasingly practised by community pharmacies. A recent study, which evaluated three major classes of Pharmaceutical Benefits Scheme medicines, found that about 20% of patients switched brands two or more times over 12 months, with the likelihood of substitution directly related to the number of available brands.2 Dealing with brand proliferation and confusionIn 2006, the Australian Pharmaceutical Advisory Council submitted a safe and effective brand substitution policy to government, promoting the use of active ingredient names.11 Unfortunately, this recommendation was not implemented, nor was a subsequent compromise agreement established by the Joint Expert Committee on Labelling Requirements for Medicines. The Pharmacy Guild of Australia has stated that “Medicine naming and packaging is a quality use of medicine issue and requires a systems/continuous quality improvement approach”.12 A recent editorial in the Journal recommended strategies to reduce medication confusion, including clear medicine labels with the active ingredient being displayed with equal or greater prominence to the brand names,13 and this was supported by the Advisory Committee on Prescription Medicines.14 Current TGA labelling guidelines recommend that Both the product name and the active ingredient names and strength should be prominently and equally displayed . . . To distinguish between the product name and the active ingredient name, the first letter of the product name should be in upper case and of the active ingredient name in lower case with a different colour for each. Fonts may be used to differentiate, but all fonts should be clearly legible.15 Guidelines are voluntary and our conclusion is that industry compliance is low. Solutions to the problemWe call on the responsible authorities, as a matter of urgency, to amend Australian and New Zealand drug labelling laws to ensure the active ingredient or generic name is displayed more prominently and in a larger font than the brand name on all pharmaceutical labels, whether prescribed or over-the-counter. This should apply to both innovator and generic products. In addition, to further distinguish between brand and generic names, we propose that the font and colours used for generic names should be unique and comparable for all medicines so as to aid consumer recognition. Brand confusion is a patient safety and a quality use of medicines concern,16 which will only worsen with time if no action is taken. National awareness and incentive campaigns funded by government and industry to ensure that all prescribers and consumers have access to electronic medicines information, including electronic health records, will be a complementary strategy to achieve quality use of medicines for all. Angiotensin-converting enzyme inhibitors available in Australia, 20106 Name No. of brands Captopril 6 Enalapril 12 Fosinopril 6 Lisinopril 17 Perindopril 10 (erbumine 9; arginine 1) Quinapril 9 Ramipril 13 Trandolapril 8 (8 active ingredients — 81 brands)

Shane L Carney MB BS, PhD, FRACP · Madlen Gazarian MB BS(Hons), MSc(ClinEpi), FRACP · Justin T Denholm BMed, MBioethics, FRACP · David M Reith FRACP, PhD · Robert K Penhall MB BS, FRACP, FRCP · Christine R Jenkins MB BS, MD, FRACP · Kay A Wilhelm MD, BS, FRANZCP · Paul A Komesaroff MB BS PhD · Mary M Osborn MPH · Richard O Day MD, FRACP

More comprehensive investment is needed to abate the extreme disadvantage experienced in some Aboriginal communities Poor housing, inadequate hygiene practices and household overcrowding directly or indirectly underlie many of the health and social problems present in most remote Aboriginal communities in the Northern Territory. Improving housing and hygiene and reducing household overcrowding are fundamental developmental steps to reduce the extreme disadvantage experienced in remote Aboriginal communities.1-2 These improvements are not only essential to improve health outcomes, but are also a prerequisite for the success of current government efforts to increase participation in the workforce, improve school attendance rates and develop safe communities.3 In this article, I discuss Australian and NT Government policies and programs aimed at Closing the Gap on Indigenous disadvantage in remote Aboriginal community contexts.4 Current initiativesThe Australian Government’s agenda to close the gap on Indigenous disadvantage is driven by three imperatives: to overcome decades of underinvestment in services and infrastructure; to encourage and support personal responsibility as the foundation for healthy, functional families and communities; and to build new understanding and respect between Indigenous and non-Indigenous Australians.4 The policy approach includes the identification of seven key “building blocks” to address specific areas of Indigenous disadvantage — early childhood, schooling, healthy homes, safe communities, economic participation, and governance and leadership. Through the National Partnership Agreement on Remote Indigenous Housing, the Australian Government is investing $5.5 billion nationally over 10 years “to tackle the housing backlog across remote Australia and to help reduce overcrowding in Indigenous communities”.4 Under the Strategic Indigenous Housing and Infrastructure Program (SIHIP), at a cost of $672 million, the Australian and NT governments will build 750 new homes, rebuild 230 existing houses and refurbish 2500 houses across 73 remote Indigenous communities and several community living areas (town camps) in the NT by 2013.5 A new system to manage public housing in remote communities has been introduced. This system includes introduction of tenancy agreements, payment of fair rent, an improved process for repairs and maintenance to homes, and improved tenant support services.6 Influences on the household mixDespite these initiatives, it appears that governments still do not recognise the complex social and cultural issues that underlie housing, health and social issues present in many remote Aboriginal communities in the NT.7,8 Non-Indigenous health workers in remote communities learn about some local practices because they need to be accommodated in the workplace — for example, avoidance relationships that exist between individuals (in some communities, between brother and sister) and protocols concerning “men’s business” or “women’s business”. However, little or nothing is known about how cultural observances shape householders’ day-to-day living practices, especially hygiene behaviour, and how housing infrastructure is perceived and used. Household overcrowding is more complex than a couple and their children living in a house too small for their needs.9 Rather, household membership comprises extended family members, and frequently includes one or more individuals with special needs (eg, frail older people, or people with psychiatric disorders and/or in poor health from chronic diseases). Households experience higher levels of stress when the behaviour of one or more family members is affected by misuse of alcohol, drugs, kava or petrol, or if problem gambling is an issue. More stress is added when a family member is in the court system, imprisoned or in juvenile detention. This household mix presents challenges for those caring for children, and those who wish to maintain good personal and domestic hygiene, and keep their house in a good condition. No quick fixWithout more extensive initiatives, providing a limited number of new, renovated and refurbished houses (compared with the size of the need) will not directly increase employment, improve school attendance, or make remote communities safer. That housing is seen as a quick fix is reflected in three case studies in the Closing the Gap — Prime Minister’s report 2011.4 In these case studies, it is inferred that new housing will enable one tenant to become employed; children will now attend school; and one tenant will now teach his children to keep the house clean. Research has shown that providing infrastructure alone will not resolve the social and cultural factors that shape people’s attitudes and behaviours.10,11 A need for supportIn late January 2011, the Australian Government reported the completion of 179 new houses and 1036 rebuilds or refurbishments in the NT.5 These additional and improved houses meet an urgent need, but it is of concern that very little has occurred to provide tenant support programs, such as life skills or homemaker programs, and improved repairs and maintenance services. Without these programs, any health or social gains as a result of the additional or improved housing are likely to be minimal.10,12 Communities’ desire for such support is evident from a perusal of Local Implementation Plans (plans developed through close consultation between governments and local reference groups that set out the priorities for each community as part of the Working Future program in the NT).13 Of the 11 NT Plans publicly available at the time of writing, eight indicate a desire for programs (eg, life skills and/or improved repairs and maintenance programs) to achieve healthy housing. Addressing key factorsThe size of the housing backlog, the poor state of many existing houses and the level of overcrowding suggest that four key factors need to be addressed in unison to achieve healthy housing in the remote Aboriginal community context: all existing housing stock be maintained in good condition; overcrowding be incrementally reduced by continuing to provide additional housing; appropriate, acceptable programs that are intensive and ongoing be provided to help improve standards of personal, domestic and environmental hygiene; and multifactorial tenant support programs be set up to deal with underlying social and other issues.10,14 Regrettably, there is little or no good-quality evidence available to know what interventions might work in this context. In the past, health promotion and life skill programs have either not been evaluated, or the evaluations have lacked rigour; as a result, the strength of any available evidence is poor.15 Past housing construction and repairs and maintenance programs in remote Aboriginal communities are contentious and generally viewed as failed or failing.16,17 Political imperatives driving the Indigenous health and housing agenda have resulted in a failure to accumulate a knowledge base in these areas. Reviews are conducted to monitor the management of SIHIP,16 but no mechanisms appear to be in place to prevent the unintended negative consequences of past housing policies being repeated. There is a danger that if Closing the Gap programs do not demonstrate progress (especially as this concerns housing), the commitment by governments to deal with the wider social determinants of health will lessen. Instead, narrow lifestyle interventions focusing on personal responsibility and individual behaviours will be introduced. There are examples of this happening already (introduction of tenancy agreements as the primary means to modify tenants’ behaviour;18 income management and the introduction of the BasicsCard;19 withholding the welfare payments to parents whose children do not attend school;20 and fining parents for children’s non-attendance at school21). These measures all reflect a simplified approach to deal with complex problems, and in most cases are not likely to be successful.22,23 More must be doneA recent strategic review of health inequalities in England recommended that to reduce the steepness of the social gradient in health, actions need to be universal, “but with a scale and intensity that is proportionate to the level of disadvantage”.3 The current approach to housing in remote communities falls short both in scale and intensity when compared with the extreme disadvantage experienced in these communities. To achieve major improvements in overall living conditions, and other Closing the Gap programs (especially education, employment and making communities safer), greater investment in a range of social and public health programs needs to accompany the current investment in infrastructure.

Elizabeth L McDonald PhD, MTH, BSc(Nurs)

Patients with cardiovascular disease may be especially prone to the adverse effects of complementary medicines Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in Australia.1 Given the chronic nature of CVD, medical management is the most common mode of care, and medications are prescribed to most patients with CVD.2 In general practice, treatment of CVD accounts for almost one in five encounters, with hypertension the most commonly treated risk factor, followed by lipid disorders.2 Although effective management of CVD depends on a range of factors, one that is often neglected is the use of complementary medicine (CM). While CM can potentially benefit patients with CVD, it can have an adverse impact on the effectiveness of conventional CVD therapies in two main ways: through drug interaction or through reduced adherence to conventional therapies. In Australia, CM is defined as the use of medicines containing herbs, vitamins, minerals, nutritional supplements and homoeopathic medicines.3 The popularity of CM has increased in recent years,4 and in people with CVD, rates of use have been estimated at up to 42%, with up to 21% of these patients taking herbal supplements.5 The most common types of CM taken by people with CVD are multivitamins and minerals (34% of surveyed cardiac patients), calcium (22%), vitamin E (20%) and vitamin C (14%). The most common herbal agents used are mint or lemon balm (11%), nettle (8%), green tea (7%), echinacea (6%) and garlic (6%). The use of coenzyme Q10 (3%), fish oil or omega-3 fatty acids (2%) and hawthorn (1%) are surprisingly low.5 Although CM is often considered safe by patients, harmful effects associated with its use do exist. The use of CM alongside prescription medications has the potential of reducing the effectiveness or increasing the potency of therapy. These effects may be compounded in people with CVD for several reasons. First, CM users tend to consume more than one CM product concurrently over periods of months to years.5 Second, the likelihood of interference with prescribed therapy is increased since certain medications, such as digoxin and warfarin, have a narrow therapeutic window. Patients with CVD also tend to be elderly, are likely to suffer from multiple comorbidities and therefore are likely to be using multiple long-term medications.5 Several studies in people with CVD indicate that not only do a significant proportion use CM concurrently with prescribed therapy, but about half do not inform treating doctors about their use.5 The relatively widespread use of CM in people with CVD means it is vital that doctors are aware of CM use. Some commonly observed interactions between CM and conventional CVD medications and possible mechanisms are summarised in the Box. Apart from the possibility of drug interactions, the bioactive components of CM products can also directly cause adverse effects. Some examples of CM that are used in the treatment of CVD (and their adverse effects) include Aloe vera (diarrhoea and potassium depletion), fenugreek (diarrhoea and hypoglycaemia), garlic (inhibition of platelet function), ginseng (insomnia), ephedra (stroke and myocardial infarction), Ginkgo biloba (bleeding) and red yeast rice (myopathy and rhabdomyolysis).7 More generally, there are safety issues associated with the quality of CMs. These relate to the lack of standard dosing, which in part is due to variations in potency, depending on where plants are grown; the possibility of contamination by pesticides and heavy metals during cultivation; and the possibility of contamination by bacteria in the storage, transport or manufacturing processes.7 The second main mechanism in which CM use may impact on effective management of CVD is through reduced adherence to prescription medications. However, a limited number of studies investigating the impact of CM on cardiovascular medication adherence show inconsistent results. Some studies report a lower adherence to prescription medications among cardiovascular patients taking CM, while others found the opposite.5 Importantly, we found in our review that CM use was not disclosed by cardiac patients up to 65% of the time. The main reasons were fear of clinician disapproval and because clinicians had not asked about CM use.5,9 This strongly suggests that clinicians need to take a less judgemental and more proactive approach to encourage patient discussion of CM use, regardless of adherence to conventional treatment. What, then, are the identifying characteristics of a CM user? In the general population, use of CM is associated with higher levels of education and income10 but poorer self-reported health status. Although few differences have been found between cardiac patients who are CM users compared with non-users,5 it appears that people with chronic disease are more likely to use CM, especially if they have multiple comorbidities.10 As well as being aware of the potential impact of CM on prescribed therapy, clinicians should also be aware of the reasons patients use CM. About half of CM users with CVD believe that CM is of greater benefit than conventional treatment, or perceive that the CM used has proven benefits for their condition.5 Many CM users also believe that there are fewer side effects associated with “natural” therapies.5 CM therefore meets a real or perceived need for health care, and serves an important psychological function in enabling patients to manage their own health.11 Given the increasing prevalence of both CM use and CVD, it is likely that clinicians will see more cases of patients who are using CM either specifically for their cardiovascular condition or towards improving general health. Regardless of personal viewpoint, CM is now an integral part of the therapeutic armamentarium used by the Australian population. Thus, there is a need to better inform doctors about CM use and the associated potential for adverse reactions and herb–drug interactions. There are significant gaps in clinician knowledge of the risks and benefits associated with CM use, and clinicians report feeling ill-equipped to respond to patient enquiries about CM.12 Medical schools overseas, such as those in Asia, France, Germany, Switzerland and some in the United States, have incorporated CM into their medical curricula. Awareness of CM needs to be integrated into routine medical practice, such as by asking patients about CM as part of a medication review. CM modules should be included in continuing professional education programs for general practitioners and specialists alike. The key issues and complexities of CM that should be understood include the differing definitions of CM in different countries, such as the American and Australian classifications, and the processes underlying its regulation. In Australia, for example, the Therapeutic Goods Administration regulates CM products, and the difference between “listed” medicines (which are not evaluated for efficacy) versus “registered” medicines is important.3 There is growing research on the efficacy of select CMs for various conditions. Results from robust studies show that omega-3 fatty acids may assist in the treatment of hypertriglyceridaemia,13 reduce the incidence of thrombotic stroke14and coronary heart disease,15 and may prevent sudden cardiac death in patients with prior myocardial infarction.16 Coenzyme Q10 supplements appear to reduce the symptom of statin-induced myalgia17 and may have favourable effects in those with heart failure.18 Physical therapies such as qi gong also appear helpful for hypertension19 and are likely to be beneficial in some patient groups as alternatives to higher intensity physical activity. Furthermore, considerable efforts are being made to investigate the efficacy of CM in CVD prevention and risk factor reduction. Research bodies such as the National Institutes of Health in the US and the National Institute of Complementary Medicine in Australia are supporting studies investigating the effects of hawthorn leaf in milder forms of heart failure, the use of disodium edetate (EDTA) chelation therapy to treat coronary artery disease, vitamin D3 for prevention of CVD and melatonin for lowering hypertension. Further research is required to strengthen the evidence base for these and other CM therapies; however, certain CMs may prove to be efficacious for people with CVD, and critical awareness of this work is necessary for effective clinical practice. The use of CM is common among patients with cardiovascular conditions and a high proportion of patients using CM believe they have remedial benefits. Many CM users also believe that CM is as safe as or safer than their prescribed treatments, and are often unwilling to inform their doctors of their use of CM products. Commonly used CM products have the potential to interfere with the intended action of prescription medications although clinician knowledge of these interactions may be limited. We have restricted our discussion to patients with CVD, although the importance of considering CM in medical management applies equally to other patient groups, especially those with chronic disease. We emphasise the need for education about CM, so clinicians become more aware of patients’ CM use, become more knowledgeable about CM, and more capable of advising their patients about this issue. Letter p 660 Potential interactions of commonly used CM with cardiovascular medications6-8 CM (prevalence of use*) Possible herb–drug interactions and mechanism of action Coenzyme Q10 (3%) May partially antagonise antiplatelet effect of clopidogrel and decrease response to warfarin Vitamin E (20%) Contains curbicin, which antagonises the effect of vitamin K on coagulation, which, with clopidogrel, may increase the risk of bleeding and potentiate warfarin effects Garlic (6%) Additive antiplatelet effects may occur with clopidogrel and other anticoagulants Ginkgo biloba (4%) Ginkgo inhibits platelet aggregation and increases the effect of warfarin Fish oil (2%) Increases the effect of antiplatelet agents and vitamin K-dependent coagulation Concomitant use of warfarin and fish oils may increase risk of bleeding Vitamin D (4%) Improves calcium absorption, which increases the toxic effect of digoxin St John’s wort (2%) Reduces the effectiveness of statins, warfarin and digoxin through induction of hepatic enzymes and P-glycoprotein Hawthorn (1%) Increases the inotropic effects of digoxin Ginseng (4%) Has an additive effect with antiplatelet agents Decreases the effect of anticoagulants Glucosamine/chondroitin (4%) Increases the effect of anticoagulants Capsicum (5%) Increases the effect of antiplatelet agents Bilberry (1%) Increases the effect of anticoagulants Aloe vera (4%) Increases the effect of antiplatelet agents Produces hypokalaemia, leading to increased toxic effect of digoxin; enhances the effect of digoxin Liquorice (prevalence of use unknown) Mineralocorticoid effects promote potassium excretion. Causes hypokalaemia when used with some antihypertensive agents CM = complementary medicine. * Prevalence of use is based on figures from a systematic review of the literature combining data from multiple studies.5

Hosen Kiat MB BS, FRACP, FACC · Yu Sun Bin BSc(Hons) · Suzanne Grant BApplSc(TCM), MPS, PhD · Dennis Hsu-Tung Chang MB BS, MSc, PhD

Preparing for a future in humanitarian medicine Many young doctors are becoming aware that their careers will be spent in an increasingly globalised society — one in which major challenges will be managed by global initiatives and not by individual nation states alone. The concept of “global health” transcending geographical borders and requiring cooperative solutions between governments, organisations and individuals is becoming widely accepted in developing and developed countries.1 Over the past decade alone, the number of individuals who identify themselves as humanitarian and global health professionals has doubled, at least in the Western world.2 It is therefore no surprise that in recent years Australian medical students have been keen to join this growing movement.3 The Australian medical education system appears to be offering more opportunities to meet these interests. Recent initiatives range from academic and education options to policy development and grassroots conferences. To some people, working for global health means serving a humanitarian organisation, so some medical students and junior doctors make it a priority to get involved with humanitarian organisations locally and abroad. However, humanitarian aid is just one subset of the global health area and requires a specific skill set. A big picture understanding of all areas of global health allows for a balanced and solid foundation.1 Those who have an appreciation of the nuances of culture, poverty, gender inequities, corporate and social governance, health diplomacy, public health, and ethnic and religious factors will make better health care providers in emergency aid and other settings. For a young medical student or junior doctor, the plethora of global health opportunities can be overwhelming. We present a list of suggestions to help medical students and junior doctors prepare for a career in global health, with some pointers for faculty members. Tips for medical students and faculty membersGet involved as early as possibleDuring our medical training, we were privileged to be involved in global health projects as junior students. These experiences reaffirmed and strengthened our interest in the global health movement by exposing us to complex issues and needs in unfamiliar environments. The Australian Medical Students’ Association (AMSA) has restructured all Australian university global health groups so they are now in the AMSA Global Health Network.4 Being an active part of a global health group at our university helped us to better understand and appreciate the challenges that pioneers working for global health face. It also allowed us time to bond and network with like-minded colleagues around the country, to exchange ideas and discuss projects, and to fundraise and initiate practical help to communities in developing regions. Attend global health meetingsThe annual AMSA Global Health Conference is a 4-day intensive program. Renowned speakers educate delegates and raise awareness of current global health issues, and students are able to interact with like-minded students and faculty members. Notable presenters with interests in global health are often invited to conduct plenary sessions, deliver a keynote speech or train students in a workshop setting. For other meetings, check the Global Health Gateway website (http://www.globalhealthgateway.org.au/), which is updated frequently to reflect new global health-related events in Australia. Arrange a global health electiveOnce armed with knowledge of the conceptual framework of the global health sector, students are strongly encouraged to spend time in a national or international location during their elective or in vacation time. This allows an invaluable opportunity to transfer principles into practical experience.5 Overseas elective opportunities can be identified using well researched books, journals and media resources. It is important to be thorough in choosing an appropriate elective. Seeking references from others who have served with the organisation or agency can be helpful. One suggestion is to approach a host hospital directly, but remember to allow enough time for applications to be processed. This year, the Australian Medical Association Council of Doctors-in-Training and AMSA have jointly authored a Medical Journal of Australia supplement, A guide to working abroad, a resource for medical students and junior doctors who want to work and/or study abroad.6 Curriculum developmentRegular dialogue between students and faculty members should be facilitated to increase interest in and commitment to global health. At the least, faculty members should be encouraged to support students who are interested in this area.7 Most other specialty and subspecialty areas are well addressed within the undergraduate medical curriculum; there should be little reason why global health should not be given some attention. Take classes focusing on global healthSome medical schools have responded to the growing interest in global health and are now offering optional classes or modules focusing on global health issues. Teaching about global health issues, addressing access and availability of health care, inequities in health services and outcome-based evaluations provide the theoretical framework in which students can structure and make sense of future or previous global health experiences.7 Ideally, the expanding role of global health education in undergraduate medical curricula will lead to a proportionate increase in the number of practical international opportunities available to students.8,9 Some medical student societies run their own short courses on global health, with different weekly lecture topics. If there are no such modules or courses available, it may be worthwhile inviting noteworthy speakers for guest lectures, symposia or workshops. A monthly journal club or meeting can also help students stay abreast of global health developments and share ideas with colleagues. Develop links with facilities in developing countriesMedical faculties and student clubs involved in the global health area should also strive to develop links with countries and health services in national or international regions. With the support of faculty members, exchanges, learning opportunities, practical placements and research openings are more likely to be sustainable and hence beneficial to communities in the resource-poor settings they intend to serve. Tips for junior doctorsDo subspecialty training in your area of interestThe value of attaining subspecialty training is rarely disputed in today’s era of specialised medical care. In resource-limited settings, this holds true as well. Groups such as Médecins sans Frontières and the International Committee of the Red Cross provide emergency and trauma surgical care in places of conflict and disaster, as well as establishing their own hospitals or working closely with local health officials to improve health infrastructure. Extra training for surgeons and anaesthetists in obstetrics and gynaecology, orthopaedics and trauma care is invaluable. Recognising that the highest mortality and morbidity arise from a lack of basic public health resources (eg, water, sanitation, food and shelter), physicians trained in paediatrics, public health, primary health care and infectious diseases (especially HIV, AIDS and tuberculosis) are urgently needed in many areas. Repay student loans as early as possibleThe reality is that most positions in humanitarian medicine are voluntary or only pay small stipends, so the earlier a student loan is repaid, the sooner there is unrestricted flexibility to work in the global health sector. It is not uncommon for hospital medical officers (HMOs) in Australia to use their salaries from locum work to fund their overseas travel and global health projects. Tips for medical students and junior doctorsLearn a foreign languageSpeaking the local language is a vital asset when practising in the field. Short courses are available, and some programs allow cultural immersion in the country while allowing day classes to learn the basics of a language within 6 weeks. Combining a medical school elective with a language course can be a viable and attractive option. Find a faculty mentor with global health interestsIt is highly beneficial to identify a mentor with interests in the global health area. Someone experienced in the field who is willing to motivate, empower, encourage, teach by example and provide advice and guidance will prove invaluable.10 A global health mentor for a medical student or junior doctor could assist in many areas ranging from research topics or collaborators to options for working in the field. The importance of working with like-minded faculty should not be underestimated. The combination of the youthful passion and enthusiasm of students and the wisdom and experience of interested and dedicated faculty members is synergistic. Choose an employer supportive of global health activitiesSome employers are more flexible and supportive of global health activities. The capability and support of a director of clinical training and the HMO roster coordinator can be deciding factors for being able to undertake an international elective or sabbatical leave from training. Elective rotations are not readily available during junior doctor residencies. HMOs may take time off or take unpaid leave to pursue their interest in the global health area. Once in a specialty training program, it can be difficult to balance training requirements with global health initiatives. A fully trained medical specialist is likely to make more complete contributions in the field. Get an additional degree in the global health areaGlobal public health is primarily population-based care, not individual-based care. The benefits of dedicating time for further study of global health include: development of theoretical and practical skills in core competencies of global public health for future practice; and opportunities for networking and setting up global public health projects, which may culminate in further research or service opportunities. Ideally, areas of global health research should be matched to a future specialty of choice. In the surgical arena, for example, future research could focus on the increasing burden of surgical disease in an area, safety of surgical care in resource-limited settings and developing long-term sustainable academic and service partnerships.11 Community health projects are also very useful for those interested in pursuing a career in family medicine, obstetrics or paediatrics. A masters qualification in international health, public health or global health science can be obtained from one of the many Australian or international schools of public health. These institutions offer degrees varying in duration, structure and online capacity, and the different courses focus on different aspects of global health. With current global initiatives calling for a blueprint for professionalising humanitarian assistance, to ensure accountability and accreditation, our suggestions become even more crucial.12,13 ConclusionAlthough by no means comprehensive, our snapshot of suggestions aims to provide medical students and junior doctors a platform to explore the myriad opportunities in the global health sector. Most importantly, we believe that students and doctors alike should continue to read extensively, ask critical questions, appreciate the global health context and become passionate about this exciting area of medicine.

Jeffrey J Leow MB BS · Daryl R Cheng MB BS · Frederick M Burkle Jr MD, MPH, DTM

Pregnant women and their health care providers deserve better drug labelling, so that risks and benefits of medications can be weighed up rationally Given that over 80% of women use at least one prescribed or over-the-counter medication (typically one to three) at some time during their pregnancy, most medical practitioners who treat women of reproductive age can expect frequent questions about the use of medications during pregnancy and breastfeeding.1 In addition, as the average age of women having babies increases, their likelihood of having medical disorders that complicate pregnancy (such as hypertension) or chronic conditions also increases. A recent Australian study found that 322 of 819 pregnant women (39.3%) reported a chronic health condition during pregnancy, the most common being asthma, blood-related disorders (eg, thrombosis, haemorrhage and/or anaemia) and diabetes.2 Of concern, 107 out of 181 of those who reported a chronic health condition and use of regular prescribed medication (59.1%) reported non-adherence to medication for a number of different reasons. Most of the participants had “some concerns” about using any medicine during pregnancy and almost one-third believed that natural remedies were safer than other medicines during pregnancy. Complementary medicines include nutritional supplements, vitamin and mineral preparations, and herbal, aromatherapy and homoeopathy products, and an estimated $1.3 billion was spent by Australians on such products in 2004.3 In an Australian study completed between 2005 and 2007, about one-third of pregnant women reported taking complementary and alternative therapies to treat common complaints during pregnancy (eg, vitamins and minerals to treat colds and leg cramps, yoga and aromatherapy).4 Complementary medicines are included on the Australian Register of Therapeutic Goods as listed (low-risk) or registered (higher-risk) medicines, but most complementary medicine products do not carry a pregnancy risk category, even though some may have significant effects on pregnancy or fetal development. Since the 1960s and the birth of babies in Australia and Europe with severe birth defects following early pregnancy exposure to thalidomide, there has been a general reluctance on the part of doctors to prescribe, and women to take, medications during pregnancy because of fears about potential teratogenic effects. In 1963, as a direct consequence of the thalidomide tragedy, the Commonwealth Department of Health established the Australian Drug Evaluation Committee (ADEC) as an independent committee to advise on the safety of new drugs being introduced into Australia and to monitor and evaluate potential adverse effects of drugs already in use. In 2010, ADEC was replaced by the Advisory Committee on Prescription Medicines. An ad hoc working party of ADEC published a unique Australian categorisation of the risk of drugs in pregnancy (Categories A, B1, B2, B3, C, D and X). In the United States, the Food and Drug Administration (FDA) adopted a labelling format for safety of drugs in human pregnancy in 1979, and other countries developed their own categorisations. The ADEC categorisation is similar to the Swedish system and, although it shares the same letters as the FDA categorisation, there are some notable differences (particularly the Australian B1, B2 and B3 categories). The first Australian Medicines in pregnancy booklet was published in 1989. The last hard copy (fourth) edition, retitled Prescribing medicines in pregnancy, was published by the Therapeutics Goods Administration (TGA) in 1999.5 This resource subsequently went online, and the currently available Prescribing medicines in pregnancy database was revamped in May 2011.6 Unfortunately, the content of the data on drug safety in pregnancy and reliance on the categories did not change. A recent audit of practice of 80 general practitioners and 50 pharmacists by MotherSafe (a counselling service for women and health care providers who are concerned about exposures during pregnancy and breastfeeding) found that both groups were generally very conservative regarding advice about medications during pregnancy and breastfeeding, relying heavily on the ADEC categorisation and company product information listed in MIMS (the Monthly Index of Medical Specialties).7 The survey found that 80% of pharmacists and GPs used MIMS (ie, the categorisations and product information, where pregnancy and lactation are almost without exception included under special precautions or contraindications) as their primary source of information on medication safety in pregnancy. While 25% of pharmacists used the Australian medicines handbook, only 4% of pharmacists and 2% of GPs used the TGA’s Prescribing medicines in pregnancy booklet. Almost half of Australian drugs fall into one of the B categories because of the paucity of available human pregnancy data. Undoubtedly the most problematic of the Australian categories is B3 — limited use by pregnant women and women of childbearing age, without an increase in the frequency of harmful effects on the fetus, but with animal data showing increased occurrence of fetal damage. If the definition of the B3 category were explained to an average pregnant woman, she would probably never take a B3 drug because of anxiety about what this could mean for her baby. However, the data regarding many B3 drugs (such as combinations of long-acting β-agonists plus inhaled corticosteroids) are limited but reassuring, and uncontrolled asthma in pregnancy is a significantly greater risk than the potential risks (derived from animal data) posed by these medications.8,9 The biggest problem of the ADEC system is its alphabetical nature, which implies (incorrectly) that there is a gradation of risk, with the B category being “worse” than the A category, and so on. Confusingly, some publications that list the categories alphabetically (eg, MIMS) add a note explaining that “allocation of a B category does not imply greater safety than the C category” — counterintuitive and distinctly unhelpful to say the least. Unfortunately, the apparent simplicity of the categories means that clinicians tend to use it as a “bible”, rather than as a guide, which can result in misinterpretation of risk. The ready availability of the categories means that practitioners would rarely critically assess the quality or content of the original studies on which the categorisation was based and, therefore, would not consider the complexities involved in balancing the risks and benefits of using or not using a particular drug for a specified indication at a certain stage in pregnancy. There is also an assumption that drugs in the same category carry a similar risk, which is often erroneous. For example, valproate and paroxetine are both in the D category, but the former is associated with a significantly increased risk of birth defects and neurodevelopmental sequelae following use in the first trimester, whereas there are conflicting data about paroxetine being associated with a slightly increased risk of cardiac and other defects. Also, the categories do not take the stage of pregnancy into account. For example, tetracyclines cause tooth discoloration in the fetus when taken after 14 weeks’ gestation, so being categorised D in the first trimester is misleading and unnecessarily worrying. In addition, the categories do not adequately differentiate between different pregnancy situations — planned versus unplanned pregnancy and essential versus non-essential medications. Furthermore, the categories rarely take the dose or route of exposure into account — topical and inhaled exposures are generally less concerning than oral or intravenous exposures as they result in less systemic absorption, lower maternal serum concentrations, and thus minimal transplacental passage and a negligible chance of affecting the embryo. The categories are assigned before drugs are marketed and are often based solely on the results of animal reproductive studies, owing to a general paucity of human pregnancy data. The categories are rarely changed despite new (and often reassuring) evidence because of a general reluctance to advocate the safety of drugs in pregnancy. Other limitations of the ADEC categorisation include the fact that it does not cover environmental agents, chemicals, infectious agents, illicit drugs or complementary medicines and that, contrary to the understanding of many medical practitioners, the categories are not applicable to breastfeeding. In general, recommendations given to women about medications in pregnancy are cautious at best and scaremongering and inappropriate at worst. Unfortunately, the advice given by health care providers is compounded by misleading information obtained from the internet and other lay sources. Misleading advice, often based largely on the ADEC categorisations, can result in significant consequences for both the mother and baby. Some women stop taking essential medication because of fears about fetal safety, thus putting themselves and their baby at risk of an untreated illness (which is often a higher risk than the potential risk posed by the medication). Other women have their medication switched, on misunderstood grounds of fetal safety, from those that are beneficial to those with unknown or less efficacy — for example, switching antidepressants from citalopram (C category) to mirtazapine (B3 category). Equally concerning is that, when pregnant women are told that they should stop their effective, prescribed medications (eg, antidepressants) because of their categorisation, some may self-medicate with complementary medicines (about which there are usually less pregnancy safety and efficacy data) or potentially more harmful substances such as alcohol, cigarettes or illicit drugs. Worse still, some women consider terminating otherwise wanted pregnancies because of perceived safety concerns based on a drug’s categorisation. In a group of 177 of callers to MotherSafe (from 2005 to 2007) who had been considering termination of a pregnancy because of a range of exposures (including drugs, radiation and vaccines), only 30% had been exposed to major teratogens such as retinoids and antiepileptic drugs. Most had received information from other sources (including health care providers and the internet), which had caused them such anxiety that they were considering terminating their pregnancy.10 For several years, concerns have been voiced about the appropriateness of the current system of labelling of drugs for safety in pregnancy in the US.11 In 2008, the FDA proposed major revisions to the labelling of prescription drugs because of these concerns. All labels would include a general statement about the background risk of birth defects for all pregnancies as well as information about whether there was an active pregnancy exposure registry for that particular agent and, if so, how to enrol in it. The new labelling would: remove the letter categorisations; present information regarding fetal risks in a more narrative style; put discussions about risk in the contexts of background risk of birth defects and drug indication; document how the risk was determined (eg, extrapolated from animal data or obtained from human data); and include information (if available) about drug dosing in pregnancy. New and relevant information would be incorporated as it became available.12 As of late 2011, the FDA’s final rule on pregnancy and lactation labelling was in the final writing and clearance process; this promises an exciting new era in the field of rational use of medicine in this important population group. Given that the FDA review has been ongoing for the past 3 years, and it will be several more years before any objective evaluation of the new US system can be made, it may be a long time before Australian regulatory authorities look at the issue of improved labelling of drugs for safety in pregnancy or implement change. I hope that this article will stimulate debate about the direction that Australian regulatory authorities should take to develop an improved, more rational approach to labelling of drugs for safety in pregnancy and breastfeeding in the near future.

Debra S Kennedy MB BS, FRACP, HGSA

As a condition of publication of phase III clinical trials, medical journals should insist on the release of all raw data and a written independent clinical audit Editorials and commentaries in some high-profile journals herald an upcoming revolution in personalised oncology.1 However, any new treatment can only be considered an advance if it: extends the life of the patient; improves quality of life; reduces the toxicity of the current best treatment; and/or reduces costs. Definitive proof of therapeutic benefit relies on freely accessible, high-quality data and their independent evaluation. Unfortunately, open access to de-identified patient data and statistical analyses remains unavailable, so only limited verification of claims emanating from commercially sponsored clinical trials is possible. This restriction reinforces concerns about reporting of trials in general, as “overestimation of the clinical benefit of a drug” is well documented.2 Further, reliance on progression-free survival (PFS) as a surrogate for the clinical benefit of a drug is a risky undertaking. PFS is subjective, as it is based on interpretation of radiological tumour size, whereas overall survival (OS) is objective and unambiguous. Despite the inherent subjectivity of PFS, Genentech requested its use as a basis for the approval of bevacizumab (Avastin) for first-line treatment of locally recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.3 However, the usefulness of PFS as a surrogate for OS, therapeutic benefit and accelerated drug approval is controversial.4-6 To understand why, it is prudent to carefully re-examine the original data, particularly as time-constrained clinicians may be unfamiliar with important details of bevacizumab’s accelerated approval. In 2007, the United States Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee evaluated data from a report of the E2100 trial,7 in which Genentech claimed an impressive 5.5-month increase in median PFS (mPFS) as a therapeutic benefit, but showed no improvement in median OS (mOS).3 Hence, the participating patients did not live longer with bevacizumab treatment. As no correlation existed between mPFS and mOS or quality of life, we asked: “What, then, are the benefits of this treatment?”8 The uncertainties regarding the strengths of Genentech’s claims were exposed by the Committee’s analysis,3 which listed many “significant protocol deviations”. These deviations were tabulated in the Committee’s analysis and included: stratification errors and treatment beyond progression (Table 3); absent radiographs for some participants (Table 5); discordance between the independent review facility and the trial investigators in PFS determination, with incorrect dates for disease progression, including a massive discordance rate of 51% of PFS date (Table 8); and more frequent dose modifications, omissions, delays and reductions in the bevacizumab arm (Tables 10 and 11).3 The Committee disagreed with Genentech’s cause-of-death attribution in several instances (Tables 15, 16 and 17) and documented a 20% increase in the incidence of grade 3–5 adverse events (including hypertension and neutropenia) in the bevacizumab arm (Tables 13 and 14).3 The Committee also analysed a precursor randomised phase III trial from Genentech (denoted AVF2119g),9 which compared bevacizumab plus capecitabine with capecitabine alone in patients with previously treated metastatic breast cancer.3 The increase in mPFS in AVF2119g was a non-significant 3 weeks, in striking contrast to the large 5.5 month value in the E2100 trial. The Committee took cognisance of the serious adverse events (Tables 19 and 20) and concluded that this trial “failed to demonstrate a statistically significant effect on PFS and overall survival”.3 Given these data, the Committee voted against approval of bevacizumab for first-line treatment of locally recurrent or metastatic HER2-negative breast cancer. Despite this recommendation, which was based on independent scientific, clinical and biostatistical analyses, bevacizumab received accelerated approval with the proviso that further confirmatory trials be conducted.4,5 Three years later, the confirmatory trials, AVADO10 and RIBBON-1 (Regimens in Bevacizumab for Breast Oncology),11 were completed. Bevacizumab plus docetaxel was compared with docetaxel plus placebo in AVADO, and capecitabine, anthracyclines or taxanes plus either bevacizumab or placebo were compared in RIBBON-1. The previous stunning 5.5-month improvement in mPFS was not seen. AVADO and RIBBON-1 yielded mPFS values of 0.8, 1.2, 1.9 and 2.9 months — again, with no improvement in mOS. Patients did not live longer and both trials confirmed “the serious risks associated with bevacizumab”.4 With this new evidence, the FDA initiated proceedings to withdraw approval for bevacizumab for metastatic breast cancer,5 a move endorsed in editorials in the Journal of Clinical Oncology and Nature Biotechnology, which concluded, respectively, that “the outcomes were arguably not clinically compelling”12 and that “if lack of [drug] efficacy in the face of toxicity is insufficient to reverse an accelerated approval, then what is?”.13 It is illuminating to compare the mPFS values from the four bevacizumab breast cancer trials (0.7, 0.8, 1.2 1.9, 2.9 and 5.5 months),7,9-11 with values from the randomised phase III trials of bevacizumab in prostate, ovarian, gastric, pancreatic and colorectal cancer (0.4, 0.6, 0.9, 0.9, 1.0, 1.4, 1.4, 1.7, 2.4, 3.8 and 4.4 months).6 First, the 5.5-month value on which bevacizumab received accelerated approval is the extreme outlier. Second, statistically significant increases in mOS occurred in only two of the above 17 patient sets.6 Clearly, statistically significant increases in mPFS were not reflected in mOS. Thus, irrespective of whether tumour size is increasing, decreasing, or remaining stable under drug treatment, tumour size changes are extremely poor predictors of how long a patient will live. The above data show that PFS is not a surrogate for OS. Evaluating the therapeutic benefit of other anti-cancer drugs requires similar in-depth data analyses. In the case of cetuximab for first-line treatment of metastatic colorectal cancer and the use of KRAS mutations as biomarkers in tumour samples, the increase in mPFS was only 0.9 months, with no increase in mOS.14 As with bevacizumab, some physicians with no ties to the study concluded that this small difference is “clinically irrelevant”.15 Similarly, claims of therapeutic benefit for rituximab in treatment of chronic lymphocytic leukaemia16 and chemotherapy-sensitive low-grade follicular lymphoma17 have been questioned, particularly as these claims were based on PFS, a largely clinically irrelevant end point in these usually indolent diseases.18-20 In breast cancer, claims for the superior efficacy and safety of anastrozole, an expensive, often toxic aromatase inhibitor, evaluated in postmenopausal women with early-stage breast cancer,21 have been challenged.22 The data failed to show a survival advantage over tamoxifen, which is cheaper and well tolerated.21 We further contend that claims of therapeutic benefit based on PFS — from the recent trials of sunitinib and everolimus in low-grade and indolent pancreatic neuroendocrine tumours,23,24 zalutumumab in recurrent or metastatic squamous cell carcinoma of the head and neck25 and vandetanib in advanced non-small cell lung cancer26 — all require additional trials before they can be considered therapeutically robust. Most of the above drugs, all with questionable therapeutic benefits, are very expensive. For example, approximate costs per month for an average patient for bevacizumab, everolimus, sunitinib or cetuximab are AUD $3400, $5700, $5800 and $7000, respectively.27 Some newer drugs, recently approved in the US and already in use in trials in Australia, are even costlier (ipilimumab for metastatic melanoma sells at US$120 000 wholesale for a four-dose course of treatment given over 3 months).28 In summary, many drugs will add a significant burden to the Australian health care system, and hence all claims based on PFS by authors of pharmaceutical-company- or academic-sponsored trials need to be carefully scrutinised by independent experts before regulatory approval. How can the evaluation of therapeutic benefit be improved? A pragmatic example has been set by the molecular, neurobiological and physical sciences communities. First, all de-identified raw data should be lodged in approved, publicly accessible databases where the data conform to minimum information standards and are in a form suitable for independent statistical scrutiny, as exemplified by the US National Center for Biotechnology Information Gene Expression Omnibus (http://www.ncbi.nlm.nih.gov/geo). Second, an independent evaluation of the data conducted by professionals with no ties to, or financial compensation from, the sponsor or its surrogates should accompany the published abstract in medical journals. This “accompanying abstract” constitutes an independent clinical audit. Public companies cannot audit their own financial returns, and it is even more important that companies whose activities involve billions of public dollars in health care expenditure should abide by standards of transparency that can be independently verified using the highest standards of scientific excellence. As a recent MJA commentary stated: Facilitating data sharing among researchers, allowing other researchers and peer reviewers to test published conclusions, testing of secondary hypotheses, simplifying data acquisition for meta-analyses, and preventing selective reporting are all important advantages.29 Medical journals and their editors have a choice — to be viewed as “an extension of the marketing arm of pharmaceutical companies”,30 or to be beacons of transparent data processes that inform clinicians, improve patient treatment, and provide high standards on which governments, health care providers and patients can have confidence. Medical journals should demonstrate strong leadership by mandating open access to detailed clinical trial protocols and de-identified raw study data. They should insist on independent audits of data, concomitant publication of an “accompanying abstract”, and lodgement of the data in independent databases; these three actions should be a precondition for publication.

Ian E Haines MB BS, FRACP, FAChPM · George L Gabor Miklos PhD

Should the recently published PCOS guidelines be revised? The recent supplement of the Journal titled “Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline” summarises the full Australian guideline document that was launched at the 2011 Endocrine Society of Australia Annual Scientific Meeting.1 The document is thorough and has been put together meticulously; it covers the major diagnostic and management issues encountered by health professionals looking after patients with this challenging condition. However, the recommendations for metabolic screening included a 2-yearly 75 g oral glucose tolerance test (OGTT) in all women with polycystic ovary syndrome (PCOS), and annual testing for those with an additional risk factor.1 I believe that this screening protocol is not based on evidence and should not be applied universally to women with PCOS. Insulin resistance is a common feature in PCOS, and many studies have shown that even lean women with PCOS are insulin resistant compared with weight-matched controls.2 However, although the major risk factors for abnormalities in glucose metabolism are amplified in these women, they are similar to those in the general population — namely age, obesity and family history of type 2 diabetes.3 Given the young age of many patients with PCOS, and the fact that a significant minority (34% in one United States study4) have a normal body mass index (BMI), the diagnostic yield of 2-yearly OGTTs in some subgroups of women with PCOS is very low. The recommendation was taken directly from a position statement that was published by the Androgen Excess Society in 2007, in which it was acknowledged that some members of the expert panel disagreed with the recommendation and suggested a more targeted approach to screening.5 In a study of 372 Australian women with PCOS, only one of 73 women who had been diagnosed with diabetes had a BMI of less than 25 kg/m2, but, in women in the cohort who were aged under 30 years (whose mean BMI was over 35 kg/m2), the prevalence of diabetes was less than 2%.3 Therefore 98% of women with PCOS under the age of 30 years could undergo an OGTT five times during their 20s with little chance of a clinical benefit. Should screening for impaired glucose tolerance, which is more common, be a sufficient reason to justify routine screening? In the same Australian study, the prevalence of impaired glucose tolerance in a very obese group was 13.4%.3 A more recent report from the US showed that only 3% of non-diabetic women with PCOS and a BMI of less than 25 kg/m2 had impaired glucose tolerance.6 Furthermore, among the principles of screening are (i) that there must be evidence that diagnosing the condition being screened for leads to treatment which is better at an earlier stage and (ii) that there should be an agreed policy on who to treat.7 Such evidence does not exist for impaired glucose tolerance screening in PCOS. Possible predictors of progression from normal glucose tolerance to abnormal glucose metabolism in PCOS have been examined. In a Canadian cohort of patients with PCOS, the best predictor of later abnormal glucose tolerance was a glucose excursion of more than 1.4 mmol/L in the initial OGTT (ie, that which returned a normal result).8 Confining future screening to those women who fulfilled this criterion would reduce the number of the OGTTs performed by 45%.8 Decision tree modelling is another technique that has been used to enable targeted screening of women with PCOS.9 Even a decision tree which uses clinical data alone (ie, age, BMI, waist circumference and waist-to-hip ratio) would reduce the number of OGTTs performed by 25%, without missing a single case of impaired glucose metabolism.9 While intuitively it would seem that delaying or preventing the diagnosis of diabetes would be good, in practice this just means a change in the glucose threshold at which intervention commences. Considering that recent large studies of type 2 diabetes have shown no evidence that aggressive glucose lowering improves macrovascular outcomes, and that it may increase mortality,10,11 we are far from a situation where earlier glucose lowering intervention in “prediabetes” is of proven benefit. The mainstay of treating patients with impaired glucose tolerance is lifestyle change and, in some cases, metformin therapy12 — established therapies for PCOS that are covered later in the guideline document.1 Some experts have stated that metformin should only be used to treat PCOS in the settings of diabetes and impaired glucose tolerance (and possibly in adolescence) and should not be used to manage infertility or hirsutism.13 This is a narrower opinion than expressed in the Australian guideline and ignores the beneficial effects that metformin may have in inducing ovulation in women with a BMI of less than 30 kg/m2 or when combined with clomiphene citrate.1 Diagnosing impaired glucose tolerance in PCOS may not lead to any particular change in management, with lifestyle change and/or metformin still the mainstay. The exception to this is women seeking to become pregnant, in whom early recognition of an abnormality in glucose metabolism enables earlier treatment and improved fetal and maternal outcomes. Predominantly though, the main diagnosis of importance from an intervention viewpoint is type 2 diabetes. My concern is that practitioners who choose to perform selective OGTT screening in patients with PCOS (based on age, BMI, waist circumference, family history of diabetes and a wish to become pregnant) will be seen as “not following the guidelines”. Patients do not find the OGTT a pleasant experience. Non-selective, frequent repetition of the OGTT in women with PCOS will create an unnecessary burden for many patients, with no proven benefit. Larger prospective studies are needed to examine whether the intensive screening protocols recommended in the Australian guideline and the intervention which arises from an abnormal result are superior to universal lifestyle advice and selective screening of women with PCOS who have a substantially increased risk of diabetes. I urge the authors of this otherwise excellent document to revise their recommendations to state that performing a 2-yearly OGTT in all women with PCOS has an extremely low yield of abnormality in certain subgroups and that no evidence of benefit exists in diagnosing impaired glucose tolerance over and above the usual treatment recommended for this common condition. Until such evidence is available, a more targeted approach to screening for glucose metabolism abnormalities in PCOS should be suggested.

Warrick J Inder MB ChB, MD, FRACP

Public health expert, Simon Chapman points to activists with hidden agendas Wind farms are a main component of efforts to harness renewable energy and reduce greenhouse gas emissions. Globally, there are an estimated 120 000 wind turbines, and this number is increasing rapidly, with China, the United States, Germany, Spain and India being the largest wind energy producers. Commercial wind farms began operating more than 20 years ago, but claims that they directly cause illness (often rapid, acute effects from even single exposures) are far more recent. Together, these observations indicate sociogenic dimensions to this latest example of anxieties about modern technology. Anti-wind-farm websites reveal an ever-expanding and often bizarre array of self-reported symptoms — tellingly never raised by landowners who earn income by hosting turbines, but rather by neighbours with land unsuitable for hosting turbines and by people with prior histories of opposition to wind farms. It has long been observed that envy of neighbours’ turbine-hosting incomes, beliefs that turbines are ugly with no local community benefit, preference for pristine bucolic environments and NIMBYism (not-in-my-backyard-ism) all predict complaints.1,2 These diverse symptoms are lumped together as “wind turbine syndrome”, a popularised catch-all term that yields zero returns from searches of the research literature in PubMed or Web of Science. The most recent review of published evidence concluded (consistent with four previous reviews) that health effects among some living near wind turbines “are more likely attributed to physical manifestation from an annoyed state than from wind turbines themselves”.3 In other words, anger about or fear of turbines can make people sick. Another review of health effects of inaudible low frequency infrasound, regularly demonised by anti-wind-farm activists as silently noxious, concluded “There is no consistent evidence of any physiological or behavioural effect of acute exposure to infrasound in humans”.4 The psychogenic and sociogenic nature of this phenomenon appears to parallel recent findings about complaints and “illness” said to be generated by exposure to mobile phone base stations and powerlines.5 The recent rise of complaints appears to be closely associated with advocacy from anti-wind-farm interest groups, such as the Waubra Foundation. Future research will need to test for temporal associations between this Foundation’s publicity and its movement through rural communities, and case reports of health effects. The Waubra Foundation’s chairman is Peter Mitchell, who has major interests in uranium and coal seam gas and, at least until February 2011, was also chairman of the Science and Economics Committee of the Australian Landscape Guardians. Like the United Kingdom-based Coastal Guardians, the Landscape Guardians have links to those who oppose wind farms but are silent on “guarding” Australian rural landscapes from mining.6 The Waubra Foundation, the Landscape Guardians and the Mitchell family’s investment company Lowell Capital all have the same post office box, yet Sarah Laurie from the Foundation wrote recently “The Waubra Foundation is not a front for the Landscape Guardians . . . Peter Mitchell . . . has kindly made his mailbox available for the use of the Foundation, as we have extremely limited financial resources”.7 The Victorian Government’s recent decision (August 2011) to allow landowners to veto turbines within 2 km of houses8 and hostile comments from the New South Wales Premier9 threaten to severely limit wind farm development in Australia. Spurious health claims fanned by anti-wind-farm activists, often with vested interests, are a key component influencing these politics. The National Health and Medical Research Council is working on an update of its 2010 review.10 That agency’s fundamental commitment to the importance of evidence-based policy will oblige it to highlight both the sociogenic aspects of this phenomenon and the competing interests of many of those standing behind the amplification of this latest textbook example of suggestion and mass hysteria.11

Simon Chapman PhD, FASSA

YES: Paediatrician Brian Conway believes freedom to practise in accordance with conscience enables healthy diversity and is the ultimate safeguard for patients The child lies in the hospital, defeated by cancer and on the edge of death. Clinicians advise that there is nothing more to do beyond keeping her comfortable. The parents disagree. Wanting absolutely everything done, they secure a court order to enforce their wishes. With every cardiac arrest, the treating team reluctantly sets to work. She has already arrested nearly 10 times through the day and staff dread the next code. The team feel distressed and angry — forced to deprive this child of a peaceful death. Their duty to her is violated. They feel the court order is forcing them to participate in child abuse. What should they do? Parents’ wishes are normally a good guide to their child’s needs and best interests, but in this case, the treating team may be best placed to identify better options. Experience and knowledge give insight into how resuscitative measures may feel for a dying child. Professional detachment assists good decision making. The parents, naturally, are far from detached and may be emotionally confused, perhaps in denial, and panicking. Better communication with the distressed couple is probably needed. Doctors should aim to build a partnership1 with patients based on trust and respect. The shared goal is to act in the best interests of the patient. Inevitable power imbalances must be managed and each party’s values and conscience acknowledged, avoiding paternalism or authoritarianism in the relationship. Doctors and patients may not always agree. A recommended treatment may be refused or poorly implemented. In this case, recommended palliative care is refused. But words like “recalcitrance” have no place here, or in the proper discourse of the doctor–patient relationship. A doctor must share with the patient the evaluation of the patient’s views, values and circumstances in considering appropriate medical responses. Conscience may guide the doctor to refuse a particular request, such as this resuscitation. The doctor ought, nonetheless, to continue to offer other care, to keep up their end of the partnership. The patient is free to seek the refused treatment elsewhere but should not coerce the doctor’s cooperation in something they believe will be harmful for the patient. For this dying girl, clinicians acting on conscience may be her only protection from harm. One prominent view, espoused by Savulescu,2 argues that conscience has no place in medicine, and doctors ought always to carry out the patient’s lawful, efficient and beneficial requests. Even though it is promoted as being anti-paternal, this model would still result in an unbalanced, authoritarian relationship, now with the patient holding all the power and the doctor reduced to mere technician, their autonomy refused. This model2 would hold no hope for the little girl burdened by the court order and panicked parents. Nor would it have held any reliable hope for the coopted subjects of the Tuskegee syphilis study,3 where dominant views, in government and the medical profession, argued that the broader social good justified the study’s continuance against repeated whistleblower conscientious objection. Medical schools and colleges must avoid any authoritarian selectivity regarding values, lest they weed out future whistleblowers or reduce needed diversity in the profession. Patients seek doctors who share their values, and sometimes because they refrain from certain procedures. Different values might be labelled “rigid” simply because they are held in the face of majority rigidity concerning contrary values. Conscience-based medicine is practised with a concern for patients’ wellbeing, recognising patients’ dignity and worth. Yet those who see little place for conscience2,4 insist that doctors who conscientiously refuse to cooperate in provision of controversial treatments that they regard as harmful should be punished like the recklessly negligent or boundary violators appearing before medical boards. Homogeneity under a majority, state or institutionally ordained value system or dictated rules has been shown in numerous historical cases to be disastrous for patient protection.3,5 The demand for lockstep adherence to required values and rules seeks to relegate conscientious objection to the realm of the unprofessional and illegal, and even the traitorous. The state legal mechanism fails the dying girl because it does not acknowledge her need for conscientious care by her clinicians. The profession and the health system failed her and her parents, because widespread confusion has been allowed to persist about the validity and desirability of attending to and following conscience, both in day-to-day practice and even in the face of court orders or administrative directives. Respect for doctors’ right to conscientiously object is the ultimate safeguard against abuses of power, error and exploitation in medicine. It is the key safeguard of the doctor–patient relationship.

Brian V Conway MB BS, BMedSc, FRACP

NO: Ethicist Julian Savulescu believes patient safety lies in objective moral standards CConscientious objection by doctors, as is commonly practised, is discriminatory medicine. Only a fully justified and publicly accepted set of objective values results in ethical medicine as a proper public service with agreed and justified moral and legal standards to which doctors should be held. Imagine that a doctor refused to examine a patient of the opposite sex on religious grounds. This is treating the patient unequally and unfairly on morally irrelevant grounds. It is sexism and therefore wrong, regardless of the doctor’s religious practice. Australian society does not and should not tolerate sexism, even if it is institutionalised by other countries or religions, or is part of the doctor’s values. Similarly, if a doctor refuses to treat a patient because they are black, or Jewish, or gay, or drunk, it is discrimination, even if conscientious discrimination. Yet some of the doctors of the future believe they are entitled to refuse to examine patients because they are of the opposite sex or drunk.1 Respect for current conscientious objection is grounded in a dangerous moral relativism: that morality and moral rightness are culture-specific, or equate to individuals’ own values and desires. This is false. Female infibulation is wrong, even in those countries and cultures that condone it. We must stand up for a non-relative morality and an objective account of interests. People should be free to live according to mistaken values or religious values. But they should not have the liberty to coerce, directly or indirectly, other people to live according to their own values, even if they are medical professionals. Freedom to practise religion does not imply freedom to impose religious values on others in a secular liberal society. The same applies to secular moral values. The place to decide what kinds of values should govern public institutions and practices is in a public forum, not by the bedside. For instance, a secular doctor might believe that people with advanced dementia or brain damage, who no longer recognise themselves or others, are not persons. She might believe it is right to kill such non-persons. However, this moral belief is not widely shared by the community at this point in time. Even though the doctor strongly believes it is morally justified, she should not kill or support the killing of specific individuals with advanced dementia but, instead, argue for legal reform in a public forum. Conscientious objection is often justified by a person saying that they are acting in a patient’s best interests. However, deciding what a patient’s best interests are requires input of the patient’s values, but is not determined entirely by them. It is partly, but importantly, an objective judgement.2 If a Jehovah’s Witness believes that a blood transfusion is not in his interests, it does not mean that a blood transfusion is against his interests. We should withhold blood transfusions from people who refuse them, to respect the objective principle of liberty, not because blood transfusion is against their personal interests. Similarly, one can, on the objective principle of distributive justice, deny further care to patients who are wasting limited medical resources through non-compliance or recalcitrance, but not because the patient offends the treating doctor’s individual values. The place of conscience is in dialogue with patients. Doctors argue for what they believe is right and engage patients in moral dialogue. This is what I call “rational non-interventional paternalism” or liberal rationalism.3,4 But in a liberal society that respects personal freedom, doctors should ultimately offer what are just, legal medical procedures. Conscientious objection will become more common because of increasing societal pluralism and treatments becoming more morally contentious. Such objection may be justified. For example, drugs developed by the use of slave labour or by the maltreatment of children in developing countries should not be used, even if licensed. Doctors should refuse to perform female genital mutilation. What distinguishes these justified objections from current refusal to perform abortions or deliver contraception? Justified conscientious objection is an objection to harming people. But harm and benefit are not in the eye of the beholder — they are grounded in a robust, morally justified concept of best interests and of moral status. Doctors should conscientiously object to female circumcision for this reason. But current conscientious objection is not morally justified because it is not grounded in a justified and agreed conception of interests. As a result, these forms of unjustified conscientious objection harm patients.

Julian Savulescu MB BS, BMedSci, PhD

We describe the implementation of an electronic medication management system (eMMS) in an Australian teaching hospital, to inform future similar exercises. The success of eMMS implementation depends on:a positive workplace culture (leadership, teamwork and clinician ownership) acceptance of the major impact on work practices by all staff timely system response to user feedback training and support for clinicians a usable system adequate decision support.

Richard O Day AM, MD, FRACP · David J Roffe BSc, BE(Elect), ME(Biomed) · Katrina L Richardson BPharm, DipHospPharm · Melissa T Baysari PhD · Nicholas J Brennan MB BS, FRACP · Sandy Beveridge MB BS, FRACP · Teresa Melocco BPharm, GradCertManag · John Ainge BSc, MB BS · Johanna I Westbrook PhD

Self-interest and global responsibility create a public health balancing act The treaty between Australia and Papua New Guinea (PNG) referred to as the “Torres Strait treaty” entered into force in February 1985.1 The treaty’s purpose is to provide certainty of the sovereignty and maritime boundaries between the two countries, including in the Torres Strait, where there are over 200 islands. The three major inhabited Australian islands of Boigu, Dauan and Saibai are situated several kilometres off the coast of the South Fly District of PNG’s Western Province (Box 1).2 In September 2009, the Australian Senate requested that the Foreign Affairs, Defence and Trade References Committee inquire into and report on matters related to the region and the treaty,3 including the administration and management of public health in and around the Torres Strait. Although the treaty excludes health access as a justification for travel, its free-movement provisions have contributed to a situation where access to Australian health services by people from PNG and public health issues — particularly those related to tuberculosis (TB), HIV/AIDS, cholera, dengue and malaria — have become major concerns. We present our analysis of the committee’s November 2010 report and highlight the increasing immigration, health, socioeconomic, cultural and human complexities that exist in the region. Such complexities require collaborative commitment between state and national governments from both sides of the border in formulating policy and providing resources. The Torres Strait treatyThe Torres Strait treaty established a Torres Strait Protected Zone. Within the protected zone, people who live in the coastal areas of PNG and Australians who are Torres Strait Islanders are permitted to travel across the border in accordance with their way of life as the traditional inhabitants of the region. Australia and PNG are divergent in wealth and development, and this divide has grown in the past 20 years. PNG has one of the poorest health records in the Pacific region and is unlikely to meet any of its health-related Millennium Development Goals.4 Communicable diseases are the major cause of death and illness across all age groups; life expectancy is 57 years;5 and 30% of children in PNG are considered to be moderately to severely malnourished.6 The health system in the remote Western Province is particularly poor.7 This area’s main health facility is Daru Island Hospital, which operates with poor infrastructure as well as ongoing staff and clinical supply shortages.8 The hospital lacks capacity to support rural areas in clinical outreach services.9 Western Province has been described as the “most economically depressed region of PNG”.10,11 Poor sanitation and water quality and limited disease-control activities result in outbreaks of infectious diseases such as malaria, HIV/AIDS and other sexually transmissible infections, TB and multidrug-resistant TB (MDR-TB).8 Unsurprisingly, the international border provides a bridge for emerging infectious diseases.9,12,13 To counter this, the treaty allows for border integrity as a public health priority — under its provisions, Australian or PNG authorities can close the border to limit or prevent free movement.14 All cross-border travel was restricted in 2009 because of the H1N1 influenza epidemic,15 and again in 2010 because of a cholera outbreak in Daru that killed 30 people.16 There is increasing alarm over the potential for a major public health crisis on Australian shores, such as MDR-TB spreading into vulnerable Aboriginal communities in north Queensland.9,12 Main committee findings related to health servicesTraditional inhabitants were exempt from usual immigration health checks at the Australian border in the Torres Strait: This exemption, under the treaty’s freedom of movement provisions, aroused locals’ “fear of likely transmission of serious diseases”. The committee highlighted that Unauthorised visitors who manage to land on the islands undetected . . . increase the risk of diseases being transmitted to people on the islands.17 PNG residents traversed the border for Australian health care services: Although access to health services is not classified as a traditional activity pursuant to the treaty, the reality was that people from PNG frequently travelled into Australia to receive treatment at Queensland Health clinics, particularly those located on the islands of Saibai and Boigu.17 Demand for Queensland Health services was increasing: Although data on the number of people from PNG who sought medical assistance in the Torres Strait were incomplete, there were “significant” and rising numbers receiving Queensland Health services. This caused a strain on Queensland Health services and subsequent access difficulties for Australian Torres Strait residents that contributed to local unease and tension.17 The committee found that the situation was complex, with “very strong push and pull factors” driving the trend for PNG residents to seek Queensland Health services.17 The factors included: A lack of health care services and resources in Western Province, and particular paucity in the South Fly District adjacent to Torres Strait. The proximity of Australian medical facilities for South Fly District residents. Queensland Health clinics on Saibai and Boigu islands are a 15–30-minute boat trip, costing about A$60 return for fuel, which was subsidised by the clinics.9 Daru hospital is a 2-hour boat ride, for which the cost of the fuel ranged from $180 to $240. Provision of health care by Queensland Health, with the support of the Australian federal government, to PNG residents who required urgent medical attention. This occurred on humanitarian and public health grounds, especially to prevent the spread of infectious diseases into Australia and throughout Western Province. Australia’s “level of care” extended to medical evacuations of people from PNG to the Australian mainland and Thursday Island Hospital,17 outside the Torres Strait Protected Zone. Only patients with acute life-threatening conditions were admitted (Box 2).15 Additional challenges identified by the committeeThe committee found that local Australian residents were concerned that Australia was sending a “mixed message” by allowing PNG residents limited access to Queensland Health services. That is, while the treaty did not allow movement for the purposes of accessing health care, Australia was nevertheless providing services on certain grounds. There was fear that this would set a precedent and foster demand for Queensland Health services, causing resentment among local Torres Strait communities and local health care managers because of the increasing use of resources. Further, Australian-based health professionals have experienced confusion over treatment protocols for visitors from PNG in the Torres Strait. The committee also acknowledged that the complex situation was muddied by the multiple government agencies operating in the region with overlapping portfolios (Box 3), resulting in inefficiencies in service provision, gaps in communication and problem planning, and potential resource mismanagement. The committee’s recommendations and the long road aheadSupport for PNG health care initiatives by the Australian Government: The aim of this recommendation is that PNG residents will eventually not need to seek Queensland Health services in the Torres Strait region. The committee acknowledged the long road ahead, particularly in the remote Western Province. While AusAID supports development of PNG’s health system substantially through cooperative capacity-building exercises, the differential between health services in Australia and PNG will persist into the foreseeable future. Reframing the health issues as a collaborative cross-border approach: Development assistance is primarily framed around a host nation’s needs. However, the Torres Strait situation warrants reframing as a regional cross-border issue and a specific project targeting the needs of both countries. This would need to move beyond the current model wherein the Torres Strait Health Issues Committee (known as the HIC), meeting twice yearly, examines health issues associated with the free border movement of PNG residents and Torres Strait islanders.7 Rather than the HIC, an adequately resourced, targeted project that deals with cross-border issues on both sides is needed, and one that particularly includes consultation with both PNG and Australian communicable disease physicians who work in the region. Increased monitoring of Australian development projects in Western Province: While the committee’s recommendation for greater accountability over how Australian development funding is spent appears to be reasonable, what is needed is a greater focus on results and mutual accountability over the outcomes that would result from a harmonised approach to this cross-border issue. Collaboration between all government agencies: The committee recognises that investment in health infrastructure by both the PNG and Australian governments in Western Province is insufficient. Continuing financial support is needed for maintenance so that the benefits of initial aid outlays are not lost — a recognition that is consistent with the redefining of sustainability in development.18 The committee encourages all agencies to work together in the use of resources, so “projects on both sides of the border should complement and strengthen each other”. The recognition that this is an “atypical jurisdiction” invites innovative solutions: the Torres Strait situation could be framed as a regional trans-border issue, and health authorities of Australia, Australian states, the Torres Strait, Western Province and PNG, as well as other stakeholders, could be invited to collaborate on developing a network of cross-border services, with defined objectives that address specific shared concerns. Given a long and continuing history of migration to the Torres Strait region from Asia and Melanesia,10 a broader regional approach could be justified. Experience from Australia’s tristate Aboriginal health services in Central Australia19 and from Mekong cross-border development collaborations20 provides appropriate models. Continued provision of services by Queensland Health to PNG residents in the foreseeable future: On humanitarian and public health grounds, the committee stated its full support for Queensland Health. Yet Queensland Health will need to be better resourced by the federal government as part of a collaborative strategy for health care services at this regional interface. Failure to recognise this as an international obligation will see Queensland Health’s commitment to communicable disease control compromised. The economic and public health implications for Australia of reducing current cross-border communicable disease strategies warrant urgent attention. This is already a demonstrable concern for Australian health professionals working in the region, with Queensland Health’s recent decision, on financial grounds, to close its TB clinics on Saibai Island. Review of Australian Government funding to Queensland to ensure it is commensurate with actual costs incurred: In view of the previous recommendation, it is unsurprising that the committee made this additional comment. Developing a cross-border project would enable clear costing of and responsibility for the agreed strategies, while building communicable disease control capacity within PNG and safeguarding Australian public health interests. ConclusionCurrent Queensland Health policy regarding access for PNG residents to health services from Australian health clinics — to provide acute services only — is in tension with public health imperatives and the long-term management of some chronic infectious diseases. Problems are compounded by the number of agencies and levels of government responsible for interlinked funding and health care provision bridging the border. Solving the problems demands a collaborative but innovative approach, with improved health services for the people of PNG in their own country as the long-term goal. In the interim, the Foreign Affairs, Defence and Trade References Committee report identifies a range of strategies and makes clear recommendations that will guide progress. These recommendations are enmeshed with concepts of health diplomacy, as international health issues have now achieved foreign policy priority.21 The risk of cross-border disease transmission in the Torres Strait is a clear demonstration that health is a global, rather than a local, agenda. People from PNG will continue to challenge the treaty provisions and seek lifesaving health services that are unattainable in their own country. A mother from Western Province making the 20-minute dinghy trip to a Queensland Health clinic seeking treatment for her young child with TB is unaware of any potential concerns of the Australian public — her need is urgent, and Australia has comparatively unlimited resources. This is the human side of the Torres Strait quandary, reminding us how intensely personal public health is, and how health and human rights arguments intersect.22,23 1 Map of the Torres Strait region, showing the boundaries between Australian and Papua New Guinean territory 2 Admissions of Papua New Guinea residents to Thursday Island Hospital, Sep 2008 – Sep 20097,15 Reason for admission* No. of patients Tuberculosis (25% had multidrug-resistant tuberculosis) 15 Obstetric case 15 Severe malaria 10 Medical trauma or care (falls, fractures, burns, violent injuries from machetes and spears, snakebite, acute and chronic eye injuries) 52 Total 92 * Only patients with acute, life-threatening conditions were admitted. 3 Overview of agencies operating in the Torres Strait Agency Government Role Torres Strait Regional Authority Australian Participate in health policy coordination, development and planning of initiatives undertaken by state and government agencies Queensland Health (QH) Queensland Manage and fund public health facilities Provide health services to PNG residents on humanitarian and public health grounds* Department of Health and Ageing Australian Provide dedicated funding to QH for Torres Strait services Undertake discrete public health activities in the Torres Strait AusAID Australian Manage Australian Government’s aid program Provide funding to PNG for health systems development in cooperation with the PNG and regional governments Department of Foreign Affairs and Trade Australian Utilise movement monitoring officers to conduct border enforcement measures to prevent breaches of treaty provisions Department of Health PNG Provide health services to PNG residents according to duty of care PNG = Papua New Guinea. * Access to QH facilities is the product of an Australian Government foreign affairs agreement.

Claire E Brolan BA, MA, LLB(Hons) · Susan J Upham BSocWk, GCIPH, PostgradDipHlthPromot · Peter S Hill MB BS, PhD, FAFPHM · Graham Simpson MD, FRCP, FRACP · Stephen D Vincent MB BS(Hons), FRACP

For many decades, Australia has been fortunate to have a low prevalence of tuberculosis (TB).1 This has resulted from a firm commitment to screening for and managing TB since early last century. Because of the low rates of disease, the current population, unfortunately, perceives TB to be a “disease of the past”. Such a perception leads to complacency, even among subgroups of policymakers, who place importance on short-sighted spending cuts over long-term TB control in an era in which drug-resistant TB is an emerging biosecurity threat to Australia. One component of effective TB control is prompt identification and treatment and monitoring of index cases and screening of contacts. In 2001, the Cairns Regional TB Control Unit initiated this response when the first case of multidrug-resistant TB (MDR-TB) was detected in the Torres Strait region.2 The initial and subsequent cases were in people from Western Province in Papua New Guinea (PNG) who resided within the Torres Strait Protected Zone and, by treaty law, are free to travel back and forth from Western Province to the outer islands of Torres Strait for traditional purposes. As new cases emerged from Western Province, the regional control unit established TB outreach services on Saibai and Boigu Islands to treat these patients, both for humanitarian reasons and to reduce the health risk to Australian citizens. The clinics employed medical, nursing and radiographic staff and had access to the Brisbane TB reference laboratory. They carried out ongoing surveillance during a patient’s treatment cycle, to detect any treatment failure or default, and post-treatment follow-up, to ensure the patient was cured. Over the past decade, the number of TB and MDR-TB cases originating from Western Province has increased substantially and the demand on the clinics has been large.2 However, the actions of the clinics have been credited with there being no MDR-TB cases detected in the Australian population in this region. The Australian clinics were set up out of necessity, as Western Province has no established, comprehensive TB service. Further, Western Province has been plagued by long-term political unrest, poverty and lack of transportation, resulting in minimal access for local residents to their regional hospital on Daru Island. The intention of the Saibai and Boigu clinics has always been to hand over care of PNG residents once a clinic and a TB outreach program were established on the PNG side of the border. Over the past few years, there have been regular meetings between Queensland TB control units, the Australian Government, the Western Province local government, the PNG national TB program team and Daru hospital staff. The aim of the meetings has been to facilitate, step by step, the transfer of responsibility for TB management to PNG, including clinical input from both Queensland and PNG health services. As yet, there is no such service within Western Province or through a clinical base at Daru Hospital with an outreach service to Western Province. Unexpectedly, during the first half of 2011, the Queensland Government directed that the TB outreach clinics on Saibai and Boigu Islands be closed in June 2011.3-5 No remedial plan for treatment continuation was included, leaving the 50 patients from PNG who were being treated for TB in a dire situation. Importantly, there was no plan for the ongoing management of patients from Western Province. Through strong pressure from TB clinicians in Australia, operation of the Australian services has been extended, and they will remain open until early 2012 to ensure completion of the treatment cycle for current patients. AusAID is supplying funding to establish TB health services within Western Province,5,6 but the program is in its infancy. There is considerable concern that extensively drug-resistant TB will emerge in the region and eventually infect Australian citizens residing in the outer Torres Strait islands.

Stephen D Vincent MB BS(Hons), FRACP

Setting the global agenda for prevention and control of non-communicable diseases — a report from the recent United Nations General Assembly high-level meeting On 19–20 September 2011, the United Nations (UN) General Assembly convened a High-Level Meeting on Prevention and Control of Non-communicable Diseases (NCDs) in New York. This is only the second time in its 66-year history that the UN General Assembly has gathered to consider a health issue, the previous occasion being for HIV in 2001. NCDs principally comprise cancer, diabetes, cardiovascular disease and chronic respiratory disease, and share four main risk factors — unhealthy diet, physical inactivity, tobacco smoking and harmful consumption of alcohol. The rationale behind the UN high-level meeting is that NCDs currently account for more than all other causes of death combined, and are estimated to have been responsible for 36 million deaths, or 63% of all deaths globally, in 2008.1 NCDs are no longer just problems of old people in wealthy countries. They now disproportionately affect the poor in low- and middle-income countries, where they also kill at a younger age — 29% of NCD deaths in these countries occur among people under the age of 60 years, compared with 13% in high-income countries.1 Two of the most telling statistics highlighted at the UN high-level meeting are the estimate that 366 million people are living with diabetes in 2011,2 and the prediction that an estimated 1 billion people could die from tobacco use this century unless urgent action is taken.3 Estimates from the World Economic Forum are that NCDs will cost more than US$30 trillion (representing 48% of global gross domestic product in 2010) over the next two decades and push millions below the poverty line.4 As Margaret Chan, Director-General of the World Health Organization, pointed out in her address to the General Assembly, NCDs are “a slow-motion disaster” that will “break the bank” unless we act. In an environment where governments and scientists alike call for an evidence base for global investments, these ballooning data are decidedly at odds with the fact that only 3% of development assistance in health is invested in NCDs — the least amount of funding compared with other health focus areas.5 It was largely the Caribbean nations agitating for global action on NCDs that resulted in the convening of the UN high-level meeting. Many lead-up meetings were held in 2011, such as the first Global Ministerial Conference on Healthy Lifestyles and Noncommunicable Disease Control in Moscow,6 in an attempt to move NCDs up the political priority list and to establish global consensus for action. The original UN resolution to convene the high-level meeting, in 2010, called for the adoption of “a concise and action-oriented outcome document”. In the run-up to the meeting, this changed into a “political declaration”. Those charged with writing the declaration had to grapple with contemporary issues that included: reduced donor funding due to the global financial downturn; donor countries wanting to remain focused on AIDS, tuberculosis, malaria, and maternal and child health; the potential for huge spending on new treatments that would be pushed on by “Big Pharma”; corporate harassment by “Big Tobacco”; and pressures from the lobbying of the food and beverage and alcohol industries. The UN is often derided for its slow and ponderous processes, but this criticism fails to appreciate that the UN is a world parliament with 193 highly self-interested and politically diverse members, with an absence of any cohesive political parties familiar to Western democracies. Despite these systemic limitations, a political declaration on NCDs was made,7 and 30 presidents and prime ministers and 100 ministers spoke at the meeting, many probably for the first time, about NCDs. A major positive outcome of the UN high-level meeting process has been the formation of the NCD Alliance, a network of more than 2000 non-governmental organisations in 170 countries, which has been formed by the Union for International Cancer Control, the World Heart Federation, the International Diabetes Federation and the International Union Against Tuberculosis and Lung Disease. Another positive was Australia’s announcement of funding towards implementation of WHO’s 2008–2013 Action plan for the global strategy for the prevention and control of noncommunicable diseases.8 Australia was well represented by Minister for Health and Ageing Nicola Roxon, whose presentation in a number of forums about legislation for plain packaging of tobacco products aroused great interest. Another pleasing feature was the presence of Peter Dutton, Shadow Minister for Health and Ageing, and the support of AusAID and the Department of Foreign Affairs and Trade, emphasising that Australia does have much to contribute in this burgeoning area of health and development. The downsides are, as Her Royal Highness Princess Dina Mired of Jordan pointed out in the opening plenary session, that the political declaration fails to name NCDs as an epidemic, that it lacks clear and measurable targets, and that it is infused with vague language. She, like many others, stressed that what gets measured gets done, and that the declaration should have sent a message to the world to reduce deaths from NCDs by 25% by 2025. It was time to stop numbering deaths and start counting survivors, she said. Another problem was that, apart from Australia and Russia, there were no pledges of funds. In all the discussions leading up to the meeting, there had been a distinct lack of interest in setting up a new agency or fund to drive and underwrite new work in preventing and controlling NCDs. Given the explosion of new health agencies and initiatives in the past decade (UNAIDS, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the GAVI Alliance, the International Health Partnership and related initiatives, and UNITAID, just to mention a few), this lack of interest is understandable — but it throws the weight of expectation back onto WHO, which has few staff working on NCDs in Geneva. Many countries endorsed the role of WHO as the key agency to progress action, but there is little doubt it will need a lot of support. Despite the backing of its Director-General Margaret Chan, it appears that WHO has less than adequate capacity for the tasks it has been given (such as setting global frameworks and indicators, and developing targets). To date, the global effort has been led from WHO’s second level of influence (the Assistant Director-General level), which means it has less than optimal internal and external support, given the many other competing issues for the organisation. WHO will need to leverage expertise and skills from bilateral, philanthropic, multilateral and academic organisations from across the globe. As we learned from HIV, it is vital that action coalesces around an agreed set of data and time-bound goals. The World Bank is starting to seriously engage in NCD prevention and treatment,9 but it will also require the active participation of other multilateral agencies, such as the Food and Agriculture Organization of the UN, the UN Development Programme, UNICEF and the International Labour Organization. Two other groups of major players are yet to get seriously involved. The first is made up of the major donor countries, such as the United States, United Kingdom, European Union and Japan, whose policy capacity, research support and funding will be vital for progress. The second consists of the major international development non-governmental organisations interested in health, such as Médecins sans Frontières, World Vision, Oxfam and CARE International, who will have to engage in NCD prevention and control. After all, evidence now suggests that development is being hampered by the impact of NCDs in low- and middle-income countries in particular.1 These countries must also invest their own resources in NCD prevention and treatment. The role of the multiple and highly diverse industries that have a stake in NCDs is unclear. Tobacco companies are so discredited internationally that they have become corporate pariahs. However, working with food and beverage, alcohol and energy companies, for example, is much more complex. On one hand, we in global health must identify the common ground where we can work together, such as workplace health promotion, food and beverage reformulation, alcohol licensing, and making drinking cultures safer. On the other hand, it is highly unlikely that there will be any accord between these industries and those interested in health over issues such as banning and limiting promotions to children, sponsorships, product warning labelling, and pricing and taxation. These issues will become the battlegrounds for the first half of this century. There are real positives to be drawn from the UN high-level meeting. The fact that NCDs have become an issue of the UN General Assembly and not just the WHO World Health Assembly in Geneva is a major plus. NCDs are now on the political agenda and in the media, and, compared with as recently as 12 months ago, an increase in interest is clearly visible. Whether, and how, this interest will be transformed into preventing premature death and disability, only time will tell.

A Rob Moodie MB BS, MPH