Letters

To the Editor: The management of pregnant women with pre-existing diabetes is often challenging for clinicians. A 38-year-old woman presented with an unplanned pregnancy at 8 weeks’ gestation. She had a 4-year history of type 2 diabetes treated with metformin, which she stopped taking on confirmation of her pregnancy. Her glycated haemoglobin (HbA1c) level was 9.0% at her first antenatal visit, and therapy with pre-meal insulin aspart and twice daily isophane was commenced. Her insulin requirement rapidly escalated, rising to 400 units per day by the end of the first trimester. Metformin therapy was reintroduced in the second trimester. Despite strategies including splitting her insulin doses and trialling different insulin regimens, control of her diabetes remained poor. At 30 weeks’ gestation, U-500 insulin became available, and that allowed rapid titration of insulin doses (Box). Her HbA1c level improved to 6.4% in the third trimester. At 35 weeks, her daily insulin requirement had reached 1455 units and her membranes ruptured prematurely. During labour, an intravenous insulin infusion rate of 90 units per hour was needed to achieve normoglycaemia. At birth, the neonate weighed 2005 g (11th percentile) with no evidence of congenital abnormalities, but she suffered transient hypoglycaemia on Day 1. Postpartum, the mother’s daily insulin requirement decreased to 28 units per day. In pregnant women with pre-existing type 2 diabetes, the insulin requirement increases substantially in the second half of pregnancy.1 In the past 12 months, among 25 pregnant women with type 2 diabetes who attended our antenatal clinic, the median insulin dose at the end of their pregnancies was 123 units per day, with 6 women requiring doses exceeding 200 units per day. At daily doses above 200 units, the therapeutic response to further increments in the insulin dose is attenuated.2 Current insulin preparations in Australia (100 units/mL) can be problematic for these patients as it is difficult to administer large volumes of insulin subcutaneously. U-500 is a preparation of regular insulin at a concentration of 500 units/mL. It is invaluable for patients with extreme insulin resistance, as a smaller volume is needed for injections. Its application during pregnancy has been previously reported.3-5 U-500 insulin is not readily available in Australia, and the preparation has to be administered by syringe. Hence, the volume of insulin must be drawn up accurately, as insulin syringes in Australia are designed for conventional lower-concentration insulin preparations (100 units/mL). This case highlights one of the many difficulties in managing pregnant women with pre-existing diabetes. The use of U-500 may be considered for women on extremely large doses of insulin and whose diabetes is still suboptimally controlled. The safety aspects of U-500 during pregnancy will need further examination. Insulin requirements during pregnancy of a 38-year-old woman with diabetes

Vincent W Wong · Alexia V Pape

To the Editor: In November 2008, a residential balcony collapse in Brisbane, Queensland, resulted in one person killed and 25 injured.1 Moments after the accident, tertiary hospitals across the city were placed on alert. Valuable hospital resources, including intensive care beds and staff, were allocated to the care of potential casualties; surgical theatres were kept on standby; and elective operating lists were cancelled. In 2008, injuries in more than 40 people across Australia and New Zealand were caused by residential balcony collapses.1-3 About 8000 Australian timber balconies are considered at risk of collapsing and potentially causing human fatality.4 Timber balconies constructed between 1970 and 1990 are at most risk of collapse.4 Many were constructed with inappropriate timber, without building approvals, and by unqualified tradespeople. When properly constructed, a well maintained timber balcony generally lasts for about 20 years.4 Collapse is not limited to timber balconies. In February 2002, a concrete cantilever balcony on a Sydney apartment fell under its own weight, shearing off the balcony under it.5 According to the Australian Concrete Repair Association (ACRA), many concrete balconies appear “safe” but have never been loaded to their maximum capacity, giving residents a false sense of security.5 As balcony parties and outdoor living become more popular, the ACRA believes that it is only a matter of time before more balconies collapse.5 A well maintained concrete balcony can be expected to last for about 40 years.4 In April 1995, the Cave Creek disaster in Pararoa National Park, NZ, resulted in the deaths of 14 people when an unstable wooden viewing platform, unable to support the weight of the 18 park visitors who had crammed onto it, collapsed into a gully.6 Following the accident, the NZ Department of Conservation made it mandatory that warning signs, indicating the maximum number of people permitted, be installed at every public viewing platform in the country.6 Why do suspended structures and public transport vehicles (such as viewing platforms, elevators and buses) have clearly displayed maximum capacity warning signs, but not balconies? Warning signs showing maximum capacity and recommended inspection dates would remind people to maintain and use their balconies safely. A prospective buyer of a home with a balcony should find out when the balcony was built and check local government records for building approvals. If no record exists, a balcony should be professionally inspected. We believe regular safety inspections and clearly displayed maximum capacity warning signs should be mandatory for all balconies. We also believe a review of building codes and standards is needed to protect residents of older homes and apartments — perhaps with an initial amnesty on unapproved balcony constructions — to encourage owners to seek professional inspections and have structural deficits corrected so that future tragedies need not occur.

Shinichiro Sakata · Craig A McBride · James W Nixon · Roy M Kimble

To the Editor: Population health and clinical researchers have long endured time-consuming submission of applications for a single study to multiple human research ethics committees (HRECs), which each have their own application forms and processes. Each HREC form collects similar information, with slight variation but much repetition. They invariably differ in emphasis and space provided, precluding a simple cut-and-paste among forms. The resource burden of completing this step in the research process has been highlighted previously.1,2 Rarely does completion of multiple applications add value. Responding to researchers’ protestations, the Australian Health Ethics Committee developed a National Ethics Application Form (NEAF). An improved version (NEAF2) was released in August 2008, with recommendations it be adopted by ethics committees Australia-wide.3 While some state health departments have embraced the new form and reform processes,4 rationalisation has not occurred in all jurisdictions. As investigators on a 3-year (2008–2010) study of cardiovascular disease that is funded by the National Health and Medical Research Council (NHMRC) and requires access to hospital records throughout Western Australia, our first ethics application was submitted in November 2007. Sequential preparation and submission to other HRECs led to the requisite approval from all 12 HRECs taking a further 12 months to achieve after the first approval. Few of these committees accepted an application using NEAF at the time. Adopting the current version of NEAF5 — adding supplementary questions pertinent to each institution (if necessary) — and rationalisation of processes to access public hospital medical records would be enormously more efficient for researchers. Centralised processes could also reduce the impost on HRECs. Our experience with contrasting requirements of the various HRECs has included different reporting timelines (6–12 months), different reminders to report, different periods of study approval (1–4 years), use of institutional letterhead, requirements for at least one chief investigator to be a staff member of the institution auspicing the HREC, requirements that investigators personally attend the HREC meeting, and differences in whether faxed and digital signatures are accepted. Such differences in requirements and processes are documented,2,6 and inevitably delay substantive research. This ongoing waste of resources and energy — in processes that distract from quality research but do not enhance ethical integrity — increases the burden on both researchers and members of HRECs. Rationalising and streamlining ethics processes could free resources, allowing greater attention to research monitoring by HRECs and research translation by researchers. We urge expedited implementation of NEAF2 and further reform. State health departments and affiliated organisations should collaborate to rationalise processes and expedite centralised or reciprocal approvals where appropriate. The bold proposal for a national system to streamline the ethics review process within and across Australian jurisdictions7 will invigorate discussion of overdue reform.

Sandra C Thompson · Frank M Sanfilippo · Tom G Briffa · Michael S T Hobbs

To the Editor: We read with interest Talley’s excellent and informative editorial about the risks associated with proton-pump inhibitors (PPIs).1 Other possible serious side effects of PPIs that need to be taken into account are potential drug interactions with aspirin and clopidogrel. Aspirin is a weak acid that crosses the mucosa in its lipid state. The suppression of acid production reduces the lipophilic nature of this drug and, theoretically, might reduce its absorption and bioavailability.2 On the other hand, clopidogrel is a prodrug that is converted in the liver to an active metabolite. This bioactivation is mediated by hepatic cytochrome P450 isoenzymes,3 with cytochrome P450 2C19 (CYP2C19) playing a particularly important role. There is evidence suggesting that some PPIs (omeprazole, lansoprazole and rabeprazole) can inhibit CYP2C19, which would alter the effectiveness of clopidogrel and potentially lead to an increased risk of adverse cardiovascular outcomes. In a recent Canadian case–control study among patients prescribed clopidogrel after acute myocardial infarction, current use of PPIs was associated with an increased risk of reinfarction (adjusted odds ratio, 1.27; 95% CI, 1.03–1.57).4 The risk was limited to patients currently taking a PPI (the authors did not find any association with more distant exposure to PPIs), and did not extend to pantoprazole, a drug that does not interfere with the conversion of clopidogrel to its active form.

Francisco J Fernández-Fernández · Gonzalo Pía · Pascual Sesma

To the Editor: In his recent editorial, Talley discusses a range of risks of proton-pump inhibitors (PPIs).1 Another rare but serious side effect of PPIs of which every doctor should be aware is hyponatraemia. Eleven cases of hyponatraemia caused by PPIs have been published.2,3 Consistent features were the rapid onset of hyponatraemia within days of commencement of the PPI therapy, the severity of hyponatraemia often being associated with confusion or delirium, and rapid recovery after cessation of the PPI medication. Test results in each case were consistent with inappropriate release of antidiuretic hormone. One case occurred 5 days after a patient changed from lansoprazole to esomeprazole.4 Hyoponatraemia needs to be considered whenever there is clinical deterioration, even after brief exposure to a PPI.

Adam P Morton

In reply: Proton-pump inhibitors (PPIs) are often coprescribed for patients taking aspirin and clopidogrel to reduce gastrointestinal bleeding. There are emerging data that omeprazole diminishes the therapeutic effect of clopidogrel because the active enzyme in the liver, cytochrome P450 2C19 (CYP2C19), metabolises omeprazole and activates clopidogrel.1,2 In a large cohort study of 8205 patients with acute coronary syndrome and taking clopidogrel, 64% were also taking a PPI (60% omeprazole); 21% of those who were taking clopidogrel but no PPI died or were rehospitalised for acute coronary syndrome, versus 30% of those taking clopidogrel as well as a PPI.3 Notably, not all the PPIs have the same metabolic pathway. For example, omeprazole and esomeprazole are principally metabolised by CYP2C19 in contrast to lansoprazole, which is metabolised by cytochrome P450 3A4 (CYP3A4), and pantoprazole, which is metabolised by CYP2C19 O-demethylation then rapid sulfate conjugation. Thus, the negative interaction with clopidogrel may not apply to all PPIs (and pantoprazole may be the drug of choice if a PPI is required, as cytochrome P450 interactions are least likely).1 However, until more data are accumulated, all PPIs should probably be avoided where possible in patients who have been prescribed clopidogrel, unless there is no alternative. It is correct that hyponatraemia has, rarely, been reported in patients taking PPIs. However, this knowledge is based solely on case report data, and therefore the level of evidence for cause and effect is relatively weak.

Nicholas J Talley · Aneta Dimoska · Kevin Gan

To the Editor: I read with interest the article by Medi and colleagues,1 but note that the authors do not mention the effect of supraventricular tachycardia on atrial natriuretic peptide — a hormone that causes vasodilation and renal excretion of sodium and water. Plasma levels of atrial natriuretic peptide increase markedly during supraventricular tachycardia.2 Pacing studies reveal that release of atrial natriuretic peptide occurs when the heart rate is greater than 120 beats/min.3 The resultant diuresis would lead to an urge to urinate and, in a prolonged episode of tachycardia, to polyuria.4,5

Weekitt Kittisupamongkol

To the Editor: We read with interest the article by Alexander and colleagues on child protection issues in severe childhood obesity.1 With one quarter of Australian youth either overweight or obese, individual families (or the health care system) will not benefit from widespread involvement of child protection services in obesity. The authors are clear on this, and describe their case as “sufficiently extreme”. The difficulty lies in defining what is “extreme” and, as health professionals, we have a duty to the community to emphasise that these kinds of cases rarely occur. The illustrative case in the article by Alexander and colleagues required an amalgamation of details from several patients (for confidentiality purposes), and we believe it would be very unusual for a 40 kg 4-year-old girl to exhibit the degree of obesity-related comorbidity described.2,3 Such a degree of “medical urgency” is usually absent when managing young obese children and, in our experience, is thankfully very extreme and markedly different from the more usual scenario of discussions around potential long-term health problems. Also, there are currently no fail-safe mechanisms in place to be 100% certain that there is not an underlying genetic, hormonal or metabolic reason for continuing weight gain in a young child. With the childhood obesity pandemic, it is impossible to routinely investigate all obese youth and, even if it were, research teams are continually finding new causes for why some children continue to gain weight irrespective of lifestyle change. Indeed, the more severe the obesity, the more likely for there to be an organic cause.4 It is not in anyone’s interests for child protection services to be automatically involved because of standard recommendations when, at a later date, an underlying medical cause is discovered. Alexander and colleagues should be congratulated on re-igniting a public discussion on this highly emotive and difficult area of health care. We agree that parenting styles may influence weight regulation in young children5 but, for the above reasons, we would urge extreme caution when considering that parents may be “neglectful”. Within our obesogenic environment, perhaps (deliberate or intentional) non-compliance is an indication that society is neglecting parents, rather than that parents are medically neglecting their children? We are concerned that the development of child protection guidelines will alienate parents and families, leading to a decline in the uptake of programs aimed at preventing and/or treating overweight and obesity. We would recommend that each case be taken on its individual merit and that primum non nocere is as important as Aristotle’s phrase of “practical wisdom”.

Matthew A Sabin · Zoe McCallum · Kay Gibbons · George A Werther · Joseph Proietto

In reply: Primum non nocere means both “first, do no harm” and “above all, do no harm”. We acknowledge there may be both potential harms (the most significant being removal of the child from the family) as well as hoped-for benefits in involving child protection services in cases of severe childhood obesity. Though we strenuously oppose notification of child protection authorities as a general policy, we raised the idea that, in exceptional circumstances, health care professionals may nonetheless have a professional and legal obligation at least to consider notifying such authorities. We did so cautiously because we fear an exception becoming a rule, particularly in services such as ours where we frequently care for children very like the “child” we describe. We agree that the development of obesity usually has multifactorial causes which will include a genetic element. We also agree on the need for public health approaches to the prevention of childhood (and adult) obesity. But whatever the underlying cause of severe obesity in a particular case, and especially in circumstances where parents seem unable to attend to the physical needs of their child, health professionals have an obligation to consider all reasonable means to limiting excess weight gain.

Shirley M Alexander · Louise A Baur · Roger Magnusson · Bernadette Tobin

To the Editor: We report a case of proximal myopathy attributed to varenicline therapy to assist with smoking cessation. A previously fit and well 27-year-old man presented to the emergency department with a 1-week history of lethargy, myalgia and limb weakness. The pain and progressive weakness incapacitated the patient to the extent of him requiring assistance to move from bed to chair. The patient’s only medication on admission was varenicline (Champix [Pfizer]), which he had started taking about 6 weeks previously to assist with smoking cessation. He denied drinking excessive alcohol or using illicit drugs. There were no symptoms of recent infection. On examination, a proximal myopathy with weakness of grade 2/5 for both upper and lower limbs was noted. The patient’s muscles were mildly tender, reflexes were preserved, and both cranial nerves and sensory examinations were normal. Respiratory function was not impaired and there was no evidence of fatigability. The clinical impression was of proximal myopathy of uncertain cause. An adverse drug reaction to varenicline was considered and the medication ceased. Appropriate blood investigations and clinical neurophysiological studies were requested. A full blood count, thyroid function tests and autoimmune screen were all normal, as were levels of electrolytes, calcium, phosphate and magnesium. The erythrocyte sedimentation rate was 15 mm/h (reference range [RR], 1–15 mm/h), the C-reactive protein level was 20 mg/L (RR, < 5 mg/L), and the creatine kinase level was 1100 U/L (RR, 30–190 U/L). Cushing disease was excluded. Two days after cessation of varenicline, the muscle weakness had improved and the creatine kinase level had normalised. The patient declined neurophysiological studies and was discharged home. On review 1 week later, he had made a full recovery. Varenicline is a recently marketed smoking cessation drug treatment that has been shown to be more effective than placebo and bupropion treatment.1 Varenicline acts as a partial agonist at nicotinic acetylcholine receptors in the brain.2 The agonist activity at these receptor sites reduces the symptoms of nicotine withdrawal and craving, while the antagonist activity blocks the reinforcing and rewarding properties of nicotine binding. Recognised adverse effects include nausea, headache, insomnia and abnormal dreams. Musculoskeletal effects are uncommon and limited to joint stiffness and muscle spasms.2 Potential mechanisms for myopathy include muscle cell degeneration induced by excess acetylcholine activity at the neuromuscular junction3 or possibly by varenicline’s affinity for the serotonin receptor.4 Enquiries to the Australian Adverse Drug Reactions Advisory Committee (ADRAC) and searches of the Canadian adverse drug reaction database and PubMed database failed to identify any reports of myopathy associated with varenicline. Thus we believe this to be the first reported case of proximal myopathy due to varenicline, and have reported the case to ADRAC accordingly.

Shelley E Wood · P Gerry Fegan

To the Editor: We are pleased that Simpson and colleagues brought the important matter of drug-dose calculation skills among Australian hospital doctors to the attention of the wider medical community.1 Data similar to theirs, suggesting inadequate calculation skills, have been reported from the United Kingdom and Germany.2-4 As teachers in the MB BS course of the University of Adelaide, we have been concerned with deficiencies in the clinical numeracy skills of our students for some time. Such deficiencies among medical students have been reported from North Carolina,5 but to our knowledge no information has been available about Australian medical students. In 2008, we included three questions on drug-dose calculations in the 90-item multiple choice question (MCQ) section of the final examination for Years 1, 2 and 3 of our course. For each question (Box), students were required to select one correct answer from five options. Although Question 1 required the knowledge that one standard drink contains 10 g of ethanol, as well as calculation skills, Questions 2 and 3 solely examined numeracy skills. The exam was completed by 177 students in Year 1, 155 in Year 2, and 119 in Year 3. The distribution of their responses is shown in the Box (with correct responses in bold). The percentage of correct responses to these questions was significantly lower than the overall score for the MCQ paper, with the exception of Question 3, which may have been too easy (as it did not discriminate between students). We believe these data support our hitherto anecdotal concerns that many students in the MB BS program have inadequate calculation skills. Although tertiary students’ numeracy problems have been attributed, at least in part, to the level of mathematics teaching in secondary schools,6 we consider they must be addressed at university level. We plan to make available an online calculation learning tool that begins with real-life non-medical examples. We are currently developing this tool with the University of Adelaide’s Mathematics Learning Centre and plan to publish our experience, including evaluation, with a view to making the tool widely available. Distribution of medical student responses to examination questions requiring numeracy skills* Question 1 (Year 1 and Year 3) A 21-year-old woman recalls drinking 5 glasses of champagne at her birthday party. Her glass holds 200 mL and the champagne has an alcohol content of 12.5%. How many standard drinks did she consume during her party? % of respondents Options Year 1 (n = 177) Year 3 (n = 119) A. 12.5 standard drinks* 50% 49% B. 5 standard drinks 6% 7% C. 18 standard drinks 1% 2% D. 6.25 standard drinks 20% 15% E. 10 standard drinks 23% 27% Question 2 (Year 2 and Year 3) You are treating a 60 kg patient for a laceration, which you will need to suture under local anaesthetic. Given that the maximum safe dose of lignocaine is 3 mg/kg, what is the maximum volume of a lignocaine 1% weight per volume (w/v) solution that can be administered safely? Options % of respondents Year 2 (n = 155) A. 1.8 mL 46% B. 6 mL 2% C. 18 mL* 35% D. 20 mL 14% E. 60 mL 1% Year 3 (n = 119) A. 60 mL 1% B. 6 mL 0 C. 180 mL 41% D. 18 mL* 38% E. 180 μL 19% Question 3 (Year 3) A 10 kg infant has viral meningitis and a high temperature. You want to treat her fever symptomatically with oral paracetamol. The preparation is paracetamol 50 mg/mL and the recommended dose is 15 mg/kg. How many mL of paracetamol syrup is the equivalent of one dose? Options % of respondents (n = 119) A. 1.5 mL 0 B. 3 mL* 96% C. 6 mL 1% D. 12 mL 2% E. 15 mL 1% * The correct options are shown in bold.

Kingsley J Whittenbury · Hubertus P Jersmann · Anne L Tonkin

To the Editor: The Australian Medical Council (AMC) now includes Indigenous health in its accreditation standards for medical schools,1 with guidelines stating that medical curricula must contain the “. . . appropriate use of educational expertise, including the educational expertise of Indigenous people, in the development and management of the medical course [emphasis added]”.1 These AMC requirements arose from the Indigenous Health Curriculum Framework, which was endorsed by the Committee of Deans of Australian Medical Schools.2 The second encounter of the Indigenous Simulated Patient Program at the University of Melbourne In the second encounter, the “patient” is concerned both about the conflicting information they have been given concerning diabetes and the need to attend multiple clinics. The “patient” attempts to explain that family and work obligations mean they cannot wait in outpatient clinics all day. The students in this session are encouraged to work with the “patient” to problem solve the issues that arise. The “patient” has been instructed to provide realistic reasons why these solutions will not work for them, highlighting possible differences in family responsibilities and living arrangements for some Indigenous community members, and demonstrating the conflicting priorities and expectations between the “patient” and the medical system. The University of Melbourne School of Medicine developed the Indigenous Simulated Patient Program in 2002 as one element of an integrated Indigenous health curriculum. The Program meets some of the goals of the framework by acknowledging and incorporating the educational expertise of Indigenous people, exposing students to Indigenous peoples’ lived experiences and world views, and by linking the simulated patient experience with other teaching content regarding the many ways in which history has affected Indigenous health. Indigenous simulated patients are used both early and late in the medical course. The early patient scenario is used within an uncomplicated communication skills tutorial, in which students practise their developing patient-interviewing skills and discover that the “patient” is Indigenous. The later scenario is more complicated (Box) and builds upon the first experience. In both scenarios, students are encouraged to ask the Indigenous patient, both in and out of character, questions about their personal experiences. The aim is to use the Indigenous Simulated Patient Program to help students understand that they will encounter Indigenous patients in their clinical studies and as junior doctors, and that these patients will have both the same and different issues from non-Indigenous patients. Solutions need to be tailored to meet the individual needs of the patient, and should include lessons from previous teaching within the curriculum — for example, the role of Aboriginal health workers in hospitals. The impact on Indigenous community members who participate in the program has been strongly affirming, with one actor commenting, “Today I felt like I really contributed to the training of medical students in issues that were important to me and my community”. Students also rate the experience very highly.3

Shaun C Ewen · Margo E Collins · Jennifer A Schwarz · Eleanor M Flynn

To the Editor: The Hon. Kevin Rudd, Prime Minister of Australia, addressed federal Parliament on 26 February 2009 regarding the Closing the gap on Indigenous disadvantage: the challenge for Australia report.1 In his speech, he asserted that government strategy to close the gap will focus on the treatment of Indigenous Australians’ illnesses “largely through the mainstream health system, because that is where 70% of Indigenous people are treated”.2 Unfortunately, the 70% figure is an urban myth based on one poorly worded question in the Australian Bureau of Statistics (ABS) National Aboriginal and Torres Strait Islander Health Survey 2004–05.3 At the National Aboriginal Community Controlled Health Organisation (NACCHO), we are concerned about the use of distorted evidence regarding the health of Aboriginal peoples, in particular the use of questionable data to formulate policies that undermine investment in Aboriginal community controlled health services (ACCHSs). In the ABS survey, a small sample of the Indigenous population were asked “Where do you usually go when you have a problem with your health?” The respondent was permitted one answer from choices that included: an Aboriginal medical service (AMS); a hospital; a doctor or general practitioner (outside hospital or AMS); traditional healer; other; or nothing. Such a question is bound to elicit misleading answers when, for example, a patient who sees his or her regular GP at an AMS selects “GP” rather than “AMS”. The technical distinction between these options is not clear, and the degree of reproducibility and reliability with which surveyors clarify the options is untested. Other Australian studies of primary care contradict the ABS findings. A recent study using 2007–08 data of the Bettering the Evaluation and Care of Health (BEACH) program found 0.9% of GP encounters are with Aboriginal and Torres Strait Islander patients.4 Over a 10-year period, this proportion has ranged from 0.7% to 1.6%.5 More than 70% of general practices do not see a single Indigenous Australian, and for the vast majority of those that do, less than 5% of their total encounters are with Indigenous Australian patients.6 In contrast, ACCHSs delivered 1 680 000 episodes of patient care to about 257 000 Aboriginal and Torres Strait Islander clients for the year 2005–06.7 Against an estimated national Indigenous population of 517 000, this indicates about 50% of Indigenous Australians use ACCHSs. ACCHSs also have more clients with complex disease than do private general practices,8,9 which supports our belief that ACCHSs target those who are “hard to reach”. Closing the gap in Aboriginal disadvantage depends on supporting Aboriginal communities towards their greater participation in primary health care. The right of Aboriginal peoples to participate in decision making that affects their health and wellbeing is the principle at stake here. The ultimate expression of this principle is community control and governance. This makes ACCHSs different to general practices, and it’s that difference that can close the gap.

Sophie Couzos · Dea Delaney Thiele

To the Editor: I read with interest the article by Andreasyan and Hoy,1 in which lower Aboriginal mortality rates were found in “very remote areas” compared with “remote areas” in the Northern Territory. In a previous article,2 I reported a similar finding from national data, based on information published by the Public Health Information Development Unit at the University of Adelaide.3 Thirty years ago, in this Journal, Morice outlined the health benefits that accrue for Aboriginal people moving away from larger settlements to live in smaller, decentralised communities where they can care for their country.4 There is an increasing literature to demonstrate that Aboriginal people living in smaller communities have better health than those living in larger settlements and regional towns. These findings have policy relevance, but they appear to be ignored by policymakers. The current Australian Government is continuing previous policies that do not support decentralised communities, but rather encourage their residents to move to larger communities or regional centres, where mortality is higher. These policies appear to be heavily influenced by allegations based on narrow economic arguments that the lack of “jobs” in small remote communities is a reason for them to be closed down.5 A minister in the previous federal government derided smaller remote communities as “cultural museums”.6 It is disturbing to note that a recent major Australian Government policy announcement stated that funding for the next 6 years . . . will support improvements to the delivery of services across 26 remote locations across the Northern Territory, Western Australia, Queensland, New South Wales and South Australia. These locations represent some of the largest concentrations of Indigenous Australians in remote Australia.7 Apparently, over 1100 smaller communities will not receive new funding. This is likely to accelerate the drift from small communities to larger settlements and towns, increasing exposure to health risks. Evidence from the Journal and elsewhere suggests that this drift will increase Aboriginal mortality. The current Australian Government has made a commitment to “close the gap” between Aboriginal and non-Aboriginal life expectancies. The Prime Minister has also stated that his government’s policies will be based on evidence.8 Yet current policies ignore the evidence for the health benefits that accrue to Aboriginal people living in small decentralised communities. These policies also ignore the known health risks associated with larger settlements. Consequently, such policies may widen rather than close the gap.

David J Scrimgeour

To the Editor: The recent article by Parker1 presents an interesting case for the establishment of a national academic college of Aboriginal and Torres Strait Islander health. The notion has been considered within Aboriginal health policy forums in the past, and the federal parliamentary Inquiry into Indigenous Health2 noted that an exploration of the merits of creating a new medical specialty for health care providers to Aboriginal and Torres Strait Islander peoples was arguably favourable. On the other hand, the concept has not gained significant support from some existing medical colleges. Broadly, the arguments supporting a college of Aboriginal and Torres Strait Islander health are that the subject is a national health priority,3 the subject has its own specialised literature, practice within an Aboriginal cultural framework is a specialised activity,4 technical aspects of health care delivery often require specialist knowledge,5 and providers of health care for Aboriginal and Torres Strait Islander peoples often act as consultants for other practitioners and policy development.6 The contrary view is that Aboriginal and Torres Strait Islander health is a health science sub-discipline within general practice, and that existing structures satisfy training needs. In terms of academic education in relation to the health of Indigenous Australians, Aboriginal community-controlled health organisations have had substantial experience and success over the past 25 years — primarily in the provision of accredited Aboriginal and Torres Strait Islander health worker training, but also in undergraduate and postgraduate training in medicine, nursing and allied health. Aboriginal representative bodies such as the National Aboriginal Community Controlled Health Organisation (NACCHO) and its Affiliates are already the arbiters of standards, benchmarks, codes of ethics, policies and protocols that define health care delivery to Indigenous Australians. With appropriate additional resourcing, it would be feasible to build on such existing expertise and infrastructure to develop a national Aboriginal and Torres Strait Islander health college. Ultimately, consistent with international principles of self-determination, Aboriginal community-controlled health organisations, NACCHO and Torres Strait Islander authorities should determine whether or not to progress the processes required for establishing an Aboriginal and Torres Strait Islander health college. They should also, as a corollary, determine the structure, function and membership of such a college, if it were to be developed.

John Daniels · Sophie Couzos

To the Editor: Compared with non-Indigenous Australians, Indigenous Australians are more likely to smoke, drink at risky levels and use illicit drugs.1 These alcohol and other drug (AOD) use patterns contribute to or exacerbate a wide range of health conditions and are significant contributors to premature death and morbidity among Indigenous Australians.2 Some attention has been paid to the efficacy of Indigenous-specific AOD programs,3 but there has been little investigation into the capacity of mainstream AOD services to respond to the needs of Indigenous Australians. To address this deficiency, we conducted a national postal survey of workers employed in agencies listed in the 2001 clients of treatment service agencies (COTSA) database. A total of 1345 workers employed in 369 agencies responded (a response rate of 38%). Most respondents (86%) indicated that their agency provided services to Indigenous clients, and that there was either strong (53%) or some (38%) need for such services. However, almost two-thirds (64%) felt that Indigenous clients’ needs were only partially met, and 9% reported that such needs were not met at all. Private sector workers were significantly less likely to report that their agency provided services to Indigenous clients than workers in government agencies and non-government organisations (NGOs) (χ2 = 102.4; effect df = 3; respondents = 1335; P < 0.001). NGO workers were significantly more likely to report a strong need for the provision of AOD services to Indigenous Australians than government and private agency workers (χ2 = 22.2; effect df = 6; respondents = 1110; P < 0.001). Workers in remote locations were significantly more likely to report a strong need for AOD services for Indigenous Australians than workers in other locations (χ2 = 24.9; effect df = 8; respondents = 1108; P = 0.002). Nearly two-thirds of all respondents reported they had no (18%) or limited (44%) access to AOD resources designed specifically for Indigenous Australians. NGO and private agency workers were significantly more likely than government workers to report limited or no access to resources designed to meet the needs of Indigenous Australians (χ2 = 17.8; effect df = 6; respondents = 1168; P < 0.001). These findings indicate a clear need to improve the capacity of mainstream AOD treatment agencies, especially those servicing remote areas, to respond to the needs of Indigenous Australians. Until improvements are made, AOD problems will continue to erode the health and wellbeing of Indigenous Australians, with predictable outcomes in relation to injury, mental health, parenting and contact with the criminal justice system. As recently highlighted by Indigenous spokesperson Mick Dodson,4 initiatives, beyond support for Indigenous workers and communities, are required to improve mainstream services for Indigenous clients in a culturally sensitive and appropriate manner.

Ann M Roche · Kenneth J Pidd · Vinita Duraisingam

To the Editor: Silva and colleagues examined the effects of swimming pools on antibiotic use and clinic attendance for infections in two Aboriginal communities in Western Australia from 1998 to 2005.1 They concluded that swimming pools led to large decreases in clinic attendances for skin infections, respiratory tract infections, and antibiotic use. The huge health and social disadvantage suffered by Indigenous children is well documented, and any interventions that demonstrate health gains should be recognised. This study highlighted important issues and the results suggested some positive outcomes. However, two weaknesses of the study deserve comment — the lack of a control community without a pool, and the selective use of baseline years. In the absence of a control community (without a pool), these results could reflect documented secular trends in Aboriginal child health overall. For example, there was a 48% overall decline in hospitalisations for childhood pneumonia in four jurisdictions, including WA, between 1998 and 2005.2 This is not significantly different from the 52% reduction reported by Silva and colleagues. Second, the selective use of baseline years potentially obscures more modest results. The authors use 1998–1999 data for the figure (Box 3) and 1999–2000 as the baseline in the main results table (Box 4). The use of the second time period (1999–2000) gives more favourable results than if the previous year had been used. By interpolation, using the first period as baseline would reduce the effect size from 68% to 35% reduction for skin infections in one community (Jigalong). In the second community, rates of skin infections were actually increasing after 2002. Swimming pools in remote Aboriginal communities appear to have many benefits, including increased showering, school attendance and enjoyment among children. We believe that this study has not demonstrated a health impact of swimming pools in these communities that is different from trends elsewhere. That said, swimming pools are a “public good” that should be available to all Australian children, especially those living in very hot places where there are few alternative recreational opportunities. Arguments about direct health benefits should not be a requirement for one group of disadvantaged Australians when we do not feel we need to make the same arguments for other Australian children.

Yvette Roe · Robyn A McDermott

To the Editor: We are concerned that conclusions drawn by Robson and colleagues1 regarding perinatal outcomes in private and public hospital settings perpetuate misinformation about safe birthing options. One of the major limitations of using routine datasets, which the authors acknowledge, is that analyses are only able to control for potential confounders held within those datasets.2 Because these datasets are not designed for research, they commonly do not contain information on all pertinent indicators. In this case, the inability to control for expected and potential pregnancy complications affecting poor perinatal outcomes means caution is warranted when drawing conclusions about the safety of public versus private intrapartum care. The public hospital system in Australia is designed to cater for women at risk of adverse events in pregnancy and labour, regardless of their health insurance status. Women with known risk factors may opt for public care in a tertiary hospital, where neonatal intensive care facilities are available. Accounting for only a few surrogate markers of social disadvantage is unlikely to control adequately for inequities in these two very different populations. As such, the extent to which the reported odds ratios are a result of differences in the type of care provided in public and private hospitals, or underlying differences in the populations that have not been adjusted for, is unknown. By attending to odds ratios only, Robson and colleagues have missed the opportunity to disseminate information about overall risk across both health sectors. Although statistical models used in their study indicate the risk of perinatal death is three times more likely in public than private hospitals (taking account of caveats already discussed), the population risk of such adverse perinatal outcomes is extremely small regardless of place of birth. When using data from secondary sources, the onus is on researchers to exercise caution in interpretation and dissemination of results, because we know the media won’t. “Babies die in public hospitals ...”3 is just one example of how the general public are fed conclusions based on insubstantial evidence. We cannot foresee any benefit in undermining trust in our public hospital system. There is, however, potential for harm if women perceive they are in a substandard system of care. It is a simplistic assertion by Robson and colleagues that women can use the information presented in their article to make choices about giving birth in either the public or private sector. For many women, there is no choice.

Georgina A Sutherland · Deirdre Gartland · Jane S Yelland · Stephanie J Brown

To the Editor: In their recent article, Robson and colleagues conclude that women are at increased risk of adverse perinatal outcomes if they give birth in public rather than private hospitals.1 We are concerned that this interpretation is likely to be false, has caused the public unnecessary alarm, and may be used to support vested interests. There are several serious limitations in the data, the analyses and the implications. The authors report that 14.3% of women (about 134 000) giving birth in Australia during the study period were excluded from the analyses. We believe that this exclusion introduces significant bias. Outcomes and sensitivity analyses should have been presented for the excluded groups, enabling the reader to interpret the findings appropriately. Pre- and post-term births and multiple births were appropriately excluded from the analysis. However, perinatal deaths due to congenital anomalies should also have been excluded. In Victoria in 2004, 19% of perinatal deaths at term were caused by congenital anomalies.2 These almost always occur in public hospitals. The authors adjusted for a number of maternal demographic characteristics in their risk assessment. Other factors known to reflect sociodemographic status, such as education, occupation and income, and low birthweight, were not included; therefore the adjustment is unlikely to be adequate. The analysis should have been stratified by hospital level of care. Women at high risk of adverse outcomes should be (and are being) cared for in tertiary public hospitals — which, unlike private hospitals, are designed to provide high-level care — as a matter of need and not of choice. The lumping together of all public hospitals in the analysis and provision of summary outcomes necessarily skews the findings. By doing this, the authors are effectively comparing apples with oranges. The proper analysis of severe perineal laceration would exclude those women who had caesarean sections, because they are not at risk of perineal trauma. Stratification by type of vaginal birth is misleading when women attempting vaginal birth in private hospitals are much more likely to experience instrumental birth than those in public hospitals. In conclusion, differential exclusion of a significant proportion of the population, inadequate adjustment for confounding factors, lack of stratification by hospital type, and inappropriate analysis of perineal lacerations are likely to lead to faulty inference and cause unnecessary alarm. This is particularly unfortunate at the time of publication of the national Maternity Services Review.3

Lyndsey F Watson · Mary-Ann Davey · Mary A Biro · James F King

In reply: We thank Sutherland and colleagues for their comments and acknowledge that dissemination of our research findings1 by some in the Australian media has caused unnecessary alarm.2,3 The data presented in our article show that there appear to be different risk profiles for women giving birth in the public and private sectors in Australia. We agree with Sutherland et al that the “public hospital system in Australia is designed to cater for women at risk of adverse events in pregnancy and labour, regardless of their health insurance status” and/or risk profile. Watson and colleagues estimate that about 19% of all perinatal deaths among term births in Victoria are due to congenital anomalies.4 This is consistent with a reported national figure of 18.1% for 2004.5 This limitation should have been acknowledged in our article, even if the analysis was not possible. Congenital anomaly data are not currently included in the Perinatal National Minimum Data Set. This limitation highlights the need for integrated uniform national perinatal data on cause of perinatal death and diagnosis of congenital anomaly.

Stephen J Robson · Paula Laws · Elizabeth A Sullivan

To the Editor: We believe the current indications for subsidised treatment of osteoporosis specified in the Pharmaceutical Benefits Schedule (PBS) encourage over-prescribing on the one hand, yet, on the other, deny many patients with osteoporosis the treatment they need. For patients under 70 years of age, the PBS indication for specific treatment, such as bisphosphonate therapy, is “established osteoporosis with minimal trauma fracture”. Thus, perhaps surprisingly, treatment is indicated for secondary prevention only. More remarkable is that patients do not need to have osteoporosis to receive the benefit: repeated enquiries to Medicare (the most recent on 3 March 2009) have confirmed that prior measurement of bone mineral density (BMD), the only practical way to diagnose osteoporosis, is not required. Yet it is well known that only 20% of women with peripheral fractures from non-major trauma actually have osteoporosis, whatever BMD T-score is used diagnostically.1 Accordingly, the current policy simultaneously denies specific treatment to patients with osteoporosis who have not yet sustained a fracture while subsidising treatment to patients with fractures who are unlikely to have osteoporosis. There is little gain from bisphosphonate therapy in women who have normal BMD and no vertebral fracture,2 but good evidence that such therapy is effective if BMD is low.3 To remedy these anomalies, we believe that bone densitometry should be more readily available — not deferred until people have fractures or reach the age of 70 years. We support a bone density measurement for all women at the menopause (and perhaps all men at age 60 years). This would identify those with osteoporosis at high risk of fracture as well as those in the low-normal range who are at high risk of developing osteoporosis.4 The first group could be offered specific therapy to prevent fractures and the second group could be advised on preventive lifestyle measures such as calcium and vitamin D supplementation and appropriate exercise. We estimate that the cost, even if there was full acceptance, would be only about $20 million a year compared with the current $8 billion yearly cost of osteoporotic fractures.5 Our recommended policy revision could pay for itself many times over, even if there were only a 10% reduction in fracture rate, not to mention improvements to be gained in the quality of patients’ lives. Early recognition of low bone density and early diagnosis of osteoporosis has the long-term potential to transform the current depressing osteoporosis picture. We do not discount the importance of minimal trauma fracture, but believe that more weight should be given to vertebral fractures and less to peripheral fractures, as the former are much more likely to be osteoporotic, much more liable to recur,6,7 and much more responsive to specific therapies.3

B E Christopher Nordin · Michael Horowitz · Barry E Chatterton

To the Editor: The National Heart Foundation of Australia believes the study by Vitry and Zhang on the quality of Australian clinical guidelines1 is useful and raises two important questions: Are guidelines approved by the National Health and Medical Research Council (NHMRC) of a superior quality, as the study suggests? and, Why doesn’t Australia have a robust, focused approach to the funding, development and implementation of clinical guidelines? Vitry and Zhang assessed various guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument. This instrument, developed by an international collaborative process,2,3 defines “quality” by two definitions: potential for bias; and content validity. The process to determine validity, however, does not test a guideline’s potential to change practice or improve health outcomes. This limitation needs to be acknowledged to avoid over-interpretation of the AGREE instrument’s ability to assess quality. Vitry and Zhang acknowledge that the AGREE instrument is not able to distinguish between “actual poor process” and “poor reporting of the methods”, recognising that some criteria for assessment involve a subjective appraisal with definitions of “effectiveness” still open to debate. Including resources developed essentially as a practice tool or quick-reference guide4 with those that received full NHMRC support5 in this study diminishes the usefulness of its conclusions from using the AGREE instrument to evaluate clinical guidelines. It’s a pity that this important study of clinical guidelines failed to account for the range of activities and resources that support the implementation of individual guidelines, including companion patient resources. These shortcomings, however, should not diminish a further key message from this study: Australia needs to abandon its laissez-faire approach to guidelines. The National Heart Foundation of Australia goes further and calls for a strong and robust national framework for the funding, prioritisation, development and implementation of guidelines. There is, as yet, no such centralised or strategic approach to guidelines development, no national register or central database for guidelines, and a poor and uncoordinated approach to guideline implementation and evaluation. In contrast, the United Kingdom has adopted a comprehensive approach through the National Institute for Health and Clinical Excellence (www.nice.org.uk), the United States has its National Guideline Clearinghouse (http://www.guideline.gov), while New Zealand has its government-funded Guidelines Group (http://www.nzgg. org.nz). The Australian Government should adopt a similar approach as part of its national health reform agenda to ensure that the best possible guidelines are developed, that they are regularly updated, that developers are well resourced to undertake this increasingly complex task and that implementation and evaluation is rigorous. The NHMRC and its National Institute of Clinical Studies (http://www.nhmrc.gov.au/nics) are obvious candidates to take this work forward, but they will need additional federal resources to enable them to do so.

James Tatoulis · Nancy P Huang · Andrew N Boyden

To the Editor: Two articles in the 19 January issue of the Journal1,2 and an article on the involvement of pharmaceutical companies in studies of their own products published in The Australian on the same day3 impel me to relate my own experience of attempting to influence my colleagues’ attitudes toward transparency in relationships with the pharmaceutical industry, and my good fortune to be working in a 21st century oncology clinical trials unit. The relationship between the science of pharmaceutical development and the science of oncology is robust and fruitful. While intending to be only mildly controversial, I caused great offence in my opening address to the Australian and New Zealand Children’s Haematology and Oncology Group annual meeting in 2008 by suggesting that it is no longer acceptable for any of us at the coalface of oncology to deal directly with pharmaceutical salespeople or for medical education to be directly funded by industry. I note the view of Tattersall and colleagues that “... sponsoring doctors to attend independent conferences is recognised as facilitating continuing medical education ...”.1 In my view, financial support for medical education should come from unaffiliated sources — perhaps competitive grants from the government, who may in turn raise funds from industry. Similarly, we must be able to deny (not just declare) a conflict of interest in our activities in clinical trials and practice, and teach the difference between clinical trials (phase III cooperative group randomised controlled trials of multidrug treatment, with wide eligibility criteria to benefit as many patients as possible) and drug trials (phase I or II single-agent trials with narrow eligibility criteria, such that adverse effects of new drugs are found quickly). Both groups of trials are essential for the benefit of patients with cancer and leukaemia, as is the need for clinicians to be — and to be seen to be — at arm’s length from industry. I have been fortunate to work in a clinical trials unit that is supported by a wise medical administration and an ethics committee devoted to the practice of clinical trials as the best evidence-based medicine for patients. Our unit has clinical research associates on staff, is an active member of the United States-based Children’s Oncology Group, and does not partake in trials directly sponsored by industry. Indeed, after 20 years in the field, I know the trade names of less than 10% of the drugs I prescribe. I decline invitations to see pharmaceutical representatives or to attend industry-sponsored events. I followed the leadership of my mentors and senior clinicians. Can I convince today’s trainees to follow suit?

Catherine H Cole

To the Editor: We support the findings of Tattersall and colleagues relating to the disclosure of competing interests by general practitioners to their patients, and we agree that greater transparency in general is required with physician–industry relationships.1 Such relationships have the potential to enhance patient outcomes through quality use of medicines. However, in the interests of a balanced perspective, several points regarding Tattersall et al’s article warrant attention. First, the 2007–08 BEACH (Bettering the Evaluation And Care of Health) survey suggests that the mean length of GP consultations in Australia is 15.1 minutes.2 Considering this, an adequate discussion or disclosure of industry links to each and every patient is simply not practical. Furthermore, the frequency with which GPs see industry representatives can vary greatly. Given these complexities, perhaps clinics could consider having a simple sign in the waiting room that states “We do/do not see pharmaceutical industry representatives”. Disclosures would be most valuable if interested parties agreed on definitions for categories of relationships and payments, uniform approaches to calculating amounts, and standards for information to be made public. Inconsistent practices could create the impression that some practices are being hidden.3 Second, we want to highlight the potential benefits of physician–industry collaborations. We recently organised a panel of Australian physicians to advise a pharmaceutical company on research initiatives that need to be undertaken in a highly specialised area of medicine. An Advisory Group Charter, describing the purpose of the group, desired outcomes, and remuneration, was developed and agreed upon by all members. In this case, physicians received remuneration for time spent reviewing documents and collecting information for the meeting, and to cover costs associated with non-attendance at clinic. The aim of the Charter and two-way confidentiality agreements was to ensure transparency. After reviewing the published literature, each physician shared information about treatment practices and outcomes. The physicians identified several areas that require further research and have the potential to enhance patient outcomes in the immediate future. However, they suggested that these initiatives could be undertaken without industry support. They advised the company to direct its research funding towards large, population-based research initiatives. This is just one example of how transparent collaborations can result in enhanced patient outcomes and a redirection of funding into areas of greatest need. While we agree that increased transparency is important for physician–industry relationships, and improvements can be made through such avenues as disclosure, a retreat from physician–industry collaborations is not in the interests of improved patient outcomes or enhanced quality use of medicines.

Brad S Dalton · Deborah J Richards

In reply: We thank Cole for her suggestions. We note the Royal Australasian College of Physicians Guidelines for ethical relationships between physicians and industry state: “Industry sponsorship to attend conferences ... should usually be restricted to those in which the professional anticipates active engagement ... and when attendance without support is not possible”.1 With regard to Dalton and Richards’ first point, our survey asked patients for their views about doctors in general and not specifically about general practitioners.2 We do agree that disclosure would be most valuable if definitions for categories of relationships and payments were agreed on. Unfortunately, the options we presented to patients in our survey did not include disclosure being presented on a website, a method that has recently been launched by the Cleveland Clinic in the United States.3 A US Senate Bill, if enacted, would require health companies to report all their financial links with doctors on a government website.4 The potential benefits of physician–industry collaboration were not presented in our survey. Obviously, having doctors advise the pharmaceutical industry is likely to be beneficial, but is it appropriate to continue relationships where industry is advising or educating doctors? Notable among the 41 recommendations of a report from a Royal College of Physicians working party in the United Kingdom, chaired by the Editor-in-Chief of the Lancet, are: the promotion of standards for prescribing at postgraduate level; a method for gradually ending the support of the pharmaceutical industry in the education of doctors in training; and any honorarium and fee, commercial or otherwise, paid to a doctor should be declared on a publicly accessible website.5 We strongly support any interventions that enhance the quality use of medicines.

Martin H N Tattersall · Aneta Dimoska