Letters

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

To the Editor: The timely article by Olver and Haines on industry-led versus investigator-led studies in cancer clearly outlines the importance of appropriate trial design.1 However, perhaps one aspect of this critical issue was underemphasised. In cancer trials, overall survival is typically seen as the primary endpoint. In fact, at time of relapse or disease progression, patients are generally treated in a non-uniform manner. In this scenario, treatment is frequently tailored depending on whether the aim of therapy is curative or palliative. Ad-hoc or experimental approaches are used for some patients with relapsed or refractory cancer. Thus, although survival is undoubtedly the most clinically relevant endpoint, the lack of standardisation of treatment at relapse inevitably confounds assessment of the impact of the study drug on survival. Furthermore, for many tumour types, full evaluation of time-to-event outcomes, such as event-free and overall survival, requires prolonged follow-up, resulting in studies taking many years to be completed. For these reasons, biomarkers that accurately serve as early surrogate endpoints to predict for clinical outcome are urgently needed. Yet a striking feature of much industry-led trial design is the paucity of correlative laboratory studies and tissue banking to identify and validate new biomolecular endpoints. Such studies are frequently seen as unnecessary and burdensome. By contrast, although investigator-led laboratory studies of novel biomarkers generate much interest from the clinical and scientific community, their resource and cost implications (chiefly data manager support) prevent many centres from participating. Lucrative company-sponsored trials will always take precedence unless state and/or federal initiatives to support investigator-led studies are enacted. Funding research nurses and data managers to help oncology units conduct non-industry trials that are well designed and incorporate laboratory-based biomolecular research would be an important beginning.

Maher K Gandhi

In reply: We support Gandhi’s contention about the value that can be added to clinical trials by performing correlative laboratory studies. The investigation of biomarkers as potential surrogate endpoints that may indicate efficacy, or lack thereof, earlier than the prolonged time sometimes required to reach a survival endpoint, is one such example. Such studies are often not funded by industry and the importance of funding these, which yield greater clinical benefit, should be recognised by government and non-government agencies. It is possible, but very unlikely, that a survival endpoint may be compromised by the lack of a standardised approach to second-line therapies. We believe that if a new first-line agent is associated with a clinically significant improvement in survival, this will be evident irrespective of subsequent therapies used, which will usually yield inferior results to first-line therapies and will most likely be distributed randomly across the treatment arms. The need for tissue banks as a resource required across trials in all tumours is something that governments could address by funding them as vital clinical research infrastructure. The same applies to data managers for non-industry sponsored trials that are well designed and incorporate laboratory-based research, as Gandhi suggests.

Ian N Olver · Ian E Haines

To the Editor: Parker and Wilkinson raised the issue of medical students who behave inappropriately.1 It is likely that the major way medical students cause distress to others is through deliberate, inappropriate behaviour, representing a deficiency in empathy, rather than through laziness or other mental or social problems. In identifying the problem in these individuals, we need to consider whether the impairment is to the cognitive aspects of empathy — knowing how to behave — or to the emotional aspects — caring about the feelings of other people.2 Inappropriate behaviour can result from differing degrees of impairment in either of these domains, and different courses of action need to be considered for those at the extremes of either type of impairment. An extreme lack of the cognitive components of empathy might be seen in those with developmental disabilities, such as autism spectrum disorders. In these cases, intensive tutoring in professional skills and appropriate career guidance can produce competent and sympathetic doctors.3 At the other extreme, a severe deficiency in the emotional aspects of empathy — not caring about other people’s feelings — may be difficult to correct. Individuals with these psychopathic traits are thought to exist at high levels in many organisations.4 They — especially those with Machiavellian and narcissistic tendencies — may alter their behaviour to become competent medical students. However, their true lack of empathy may become apparent when their careers are secure, and they are in positions of real power. At that stage, they might put patient health and the psychological state of their colleagues at much greater risk. It is likely that some of the most dangerous doctors, such as Harold Shipman in the United Kingdom, represent extreme examples of this pattern. Medical schools need to be certain that any behaviour problems are truly correctable, and consider a thorough personality and cognitive assessment for students who present with inappropriate behaviour, to determine a course of action that will ensure the safety of future patients and colleagues of these students.

Sarah J Abrahamson

To the Editor: Controlled breathing is a fundamental principle of marksmanship. I describe an effect of viral lower respiratory tract infection on small arms training that was unexpectedly prolonged. The patient (myself) had abrupt onset of respiratory infection, 1 day after a marksmanship training session on an electronic firing range. During the session, I obtained satisfactory scores from several firing positions (best score, 66 mm grouping for five shots and 126 mm grouping for 20 shots, at 200 m, prone firing position). The illness progressed rapidly from a non-specific prodrome to a flu-like illness with fever, malaise, muscle aches, lethargy, slowed cognition, cough, sore throat, rhinorrhoea, persistent lacrimation and a 24-hour period of prostration. Recovery began after 48 hours, allowing a return to light work at 72 hours and full working duties by Day 7. On Day 14, during another marksmanship training session, my accuracy was severely decreased. I failed to obtain satisfactory scores in any position because of persistent erratic breathing and occasional involuntary coughing (best score, 235 mm grouping for 20 shots at 200 m). Spirometry later that day showed a reduced peak flow rate (310 L/min) (see Box). Serological tests were negative for IgG and IgA for all respiratory agents assessed. Nasal swabs were positive for parainfluenza virus type 3 by polymerase chain reaction testing. Involuntary coughing, particularly towards the end of the day, and decreased exercise tolerance persisted for a further 2 weeks, by which time peak flow had increased to 500 L/min. A third marksmanship session the week afterwards showed an improvement in scores, but they were still worse than those obtained pre-infection. Notably, grouping deteriorated rapidly after the first series of 20 shots, and could not be regained even after short rests. Replay of the recorded laser beam pattern for the session indicated that the breathing pattern remained erratic, although peak flow had risen further to 550 L/min. In the aftermath of the First World War, the joint head of Germany’s forces, Ludendorff, claimed that the failure of his 1918 spring offensive was ultimately caused by epidemic influenza.1 The epidemic affected German troops later than the allied forces, in June 1918. By July 1918, there were an estimated 500 000 German influenza casualties. Ludendorff’s initial successes were a result of new, highly mobile type infantry tactics — the forerunner of today’s “fire and movement” — which require physical fitness, stealth and accuracy of rifle fire. My case demonstrates that the tactical consequences of a viral lower respiratory infection can last much longer than medically explicit morbidity. Prolonged effects in my case included persistent involuntary cough, loss of exercise tolerance and loss of marksmanship, weeks after the initial acute illness. Ludendorff’s claim may be not so far off the mark. Marksmanship scores* and peak flow rates over time after onset of a respiratory tract infection * Lower scores for shot grouping indicate better marksmanship (shots are more closely grouped).

Timothy J J Inglis

To the Editor: I read with interest the research article by O’Connor and colleagues, which concluded that the medical and retrieval costs of road crashes in rural and remote northern Queensland represent “a considerable economic burden”.1 Although the authors noted that the broader Rural and Remote Road Safety Study aimed to also gain an understanding of the social costs of such crashes, they focused on the monetary costs in this report. As we all know, road crashes not only cost money but have enormous personal impact, in both the short and long term, on the patients and their families. This impact is likely to be even greater for patients from rural and remote areas who are unable to be cared for in their local hospital. Remember that for almost all patients transferred, there are families who must also find their way to, and temporary accommodation (sometimes for months) in, an unfamiliar large town or city. Close family members, in addition to the patient, also suffer loss of income, disruption of schooling, and loss of personal network support due to the geographic dislocation. Thank you to the authors of this study, which reinforces the desperate need to continue to improve local health services in rural and remote Australia, including “more efficient trauma management”,1 to contain costs and to lessen patient and family suffering.

Susan M Gorton

In reply: We can only agree with Gorton about the high level of costs to families and communities caused by road trauma. While our report attempted to provide estimates of the immediate, direct costs to the medical system,1 we were well aware of the additional costs to families, particularly those from rural and remote areas, as they attempted to support their injured family member. These costs, unfortunately, are difficult to quantify, and have a long-term impact on families and communities. Although our study was able to estimate some of the costs associated with road trauma, there is a need for prospective studies with specially formulated costing tools to capture the costs more fully. An associated study describing the impact of road trauma on the work of general practitioners in rural and remote areas2 outlined the problems that GPs have in managing chronic vehicle-related trauma without access to specialist rehabilitation services. Improving local health services may reduce some costs to families, but many of the patients retrieved from rural road crashes initially require specialist care in tertiary-level facilities. Changing the behaviour of drivers who take risks on roads will also reduce the costs of road trauma. Unfortunately, this is a difficult process.

Teresa M O’Connor · Heather A Hanks · Mark S Elcock · Richard C Turner · P Craig Veitch

To the Editor: More than 1000 sunscreen products are marketed in Australia, and an increasing proportion (about one-third) incorporate engineered nanoparticles (ENPs). Defined as manufactured particles having one or more dimensions less than 100 nm (0.00001 cm), ENPs exploit the altered chemical reactivity and other changes that reduction to nanosize elicits. ENPs in sunscreen, such as titanium dioxide (TiO2) and zinc oxides, constitute effective broad-spectrum ultraviolet radiation (UVR) blocking agents with enhanced cosmetic transparency. The Australian Therapeutic Goods Administration (TGA), in approving such products, has stated that “there is no evidence that sunscreens containing these materials pose any risk to the people using them”.1 Similarly, authors of a recent article (written in collaboration with representatives of a cosmetic company) interpret the evidence as confirming that ENPs do not penetrate below the stratum corneum, or only in small amounts, producing limited cellular toxicity.2 Information on sunscreen packaging is not required to disclose the presence of ENPs. Yet, when TiO2 nanoparticles are incorporated into human cells in vitro, mobilisation of electrons by absorption of ultraviolet A (UVA) light produces reactive oxygen species and causes DNA damage (strand breakage and base modification). In fact, TiO2 has been used in this way to kill cancer cells in vitro.3 In sunscreens and cosmetic preparations, TiO2 is often coated to reduce this photocatalytic activity because over 90% of ambient UVR is UVA. However, evidence has now emerged that TiO2 in uncoated anatase form has been added to a marketed but as yet undivulged Australian sunscreen — in this form, TiO2 is capable of producing damaging photocatalytic free-radical reactions on particular steel roofing materials.4 Likewise, zinc oxide ENPs manufactured for use in sunscreens are potent biocides and subject to disposal restrictions in most countries. Despite the TGA’s stance, existing research does not comprehensively ensure the safety of all ENPs in sunscreens, particularly ENPs less than 40 nm in size applied long term to human skin that is immature, aged, diseased, damaged, hairy or covering flexural creases.5 The non-government organisation Friends of the Earth has compiled a list of sunscreens available in Australia that are claimed by the manufacturers to be free of nanoparticles.6 A New South Wales Government committee has recommended that, for regulatory purposes, ENPs be considered new chemical entities that require increased safety data.7 Policymakers should increase funding for objective research in this area (such as that by Macquarie University and the flagship project in nanotechnology of the CSIRO [Commonwealth Science and Industry Research Organisation]). Until such safety data are available, the TGA should apply the “precautionary principle”5 and, at a minimum, increase packaging information about nanoparticles in sunscreens.

Thomas A Faunce

Sed quis custodiet ipsos custodes? (Who guards the guardians?) To the Editor: Adler and Constantinou raised a concern about the ageing doctor1 that also worried me when I was practising as an anaesthetist. The same concern was raised recently in the Australian and New Zealand College of Anaesthetists Bulletin.2 In anaesthesia, decisions and actions have to be made in seconds and minutes, rather than days and weeks, and maintenance of standards is very important. Doctors practise largely in isolation, and may not be aware of their standard failing against the general standard. Operating theatres offer both an opportunity to observe the practice of others and a conduit for information on colleagues — nursing and medical. I used this opportunity in private and public practice by asking younger colleagues, one in each, to be my “buddy”, as in diving safety. They were asked to keep watch for any rumour of my declining standards and to report it to me. We would then discuss what to do: retrain or retire. The latter became more of an option the older I grew. This strategy opened up pathways. One was that the buddy was given the authority to approach me on the topic. Another was that I was open to the idea that my ability could diminish, while a third was that the hostility, so often seen in this setting, was abolished. I would rather be tapped on the shoulder by a sympathetic colleague than a medical board, a hostile coroner or a vindictive prosecution lawyer. In the end, there was no tap on the shoulder, and I went because I had had an enjoyable and rewarding career and could afford to retire. This allowed succession planning in both areas, public and private, and a younger colleague could embark on a similar path.

David G Fenwick

To the Editor: We read with interest the recent editorial by Van Der Weyden on the issue of doctor displacement.1 We agree completely that a transparent and evidence-based approach to health care roles is essential. In proposing a pilot program of physician assistants (PAs) in South Australia to examine the potential of “physician extenders”, we broadly used the model applied to the introduction of new therapies in medicine, including new drugs: Evidence of an unmet need; Evidence of safety and efficacy in another setting; A monitored pilot/trial in practice; Re-evaluation after a defined period with a defined process; and An emphasis on any ongoing utilisation being a consistent and national process. This last point is noted in the Australian and New Zealand College of Anaesthetists’ submission to the National Health and Hospitals Reform Commission.2 We emphasised the need for any proposed future clinical role for PAs to be defined, followed by identification of the required knowledge base, training and education requirements, and certification. Not all new health care roles have followed such a pathway, and this provides potential challenges for ensuring quality, safety, consistency and “trademark definition” (widespread understanding of the role). In the case of PAs, it was evident at a recent International Forum for Physician Assistant Education in the United States that the definition of the term “physician assistant” varies greatly internationally, potentially confusing future debate on this topic in Australia. Hence, to develop a robust Australian model, any proposals for ongoing use and training of PAs would have to be discussed at a national level.

Guy L Ludbrook · Guy J Maddern

To the Editor: The Journal’s Editor is a man of words and we love him for it, but, as Lord Tennyson said: “For words, like Nature, half reveal and half conceal the Soul within” (In memoriam A. H. H., 1850). So what does his Christmas issue editorial1 really reveal about our man of words? He has unfortunately biased the debate about physician assistants and other alternative health care providers with his editorial’s very title: “Doctor displacement”. Doctors will not be displaced — liberated, perhaps, to concentrate on things that interest them, where their advanced skills can be best used and where they can make the most impact. This is not (nor should it be) about maintaining the status quo. The debate should be about how to provide health care to patients and the community, ensuring that they can get appropriate advice from well trained professionals when and where they require it. Most health services are now provided by teams — no longer is it ethical to promote the idea of an autonomous practitioner, be it nurse or doctor. The great strength of the physician assistant is that it is a “delegated model”, dependent on the doctor and not, as the editorial suggests, able to practise independently. Physician assistants will never be able to practise independently; they will always have to practise under supervision and within the scope of practice of their supervisor. Nowhere in Van Der Weyden’s editorial is the issue of preventive health, as an important physician assistant or other health professional role, raised, nor the fact that health professionals might use teleconsulting to link across disciplines and geographical areas. These are aspects that could change workforce requirements dramatically. Australia currently spends a minor fraction (less than 5%) of its $90 billion health budget on trying to prevent illness.2 We must use our health dollars more wisely and effectively. Also absent from the editorial is mention of the current global shortage of 4.5 million health workers. On this point, the MJA should look to the Lancet to see how it has consistently run a global agenda on health services and workforce, pointing out our responsibilities to low- and middle-income countries.3 The world is divided into those with and those without effective health care. Opinions on proposed changes to health care split into those who say “why?” and those who say “why not?” Editor, you have always appeared to us to be in the latter group. Please don’t disappoint us now by becoming a nay-sayer. We want to see this Journal promoting a health system that is patient-focused and health professional-friendly, and not one that just maintains the status quo.

Peter M Brooks · Charles A Mitchell

In reply: I appreciate the comments of Brooks and Mitchell on the importance of words to editors — they are, after all, their tools of trade. Indeed, this is no more so than in the titles of editorials, wherein their succinctness must not only encapsulate the tone and theme of the text but, having captured the readers’ attention, induce them to read on. It seems, however, that the title of my recent editorial “Doctor displacement: a political agenda or a health care imperative?”1 has caused disquiet and prompted the accusation of “bias”. And the offending word? “Displacement”. The Concise Oxford Dictionary defines the verb “displace” as: “shift from its accustomed place”, “remove from office” and “take the place of; oust”. Given the substance of the editorial, it was my intention that all these connotations were relevant in the context of this many-layered debate. In essence, the editorial focused on the urgent need for the profession to address, or at least debate, the increased instances of “task transfer” or “role substitution” occasioned by the escalating numbers of nurse practitioners and physician assistants. Despite Brooks and Mitchell proffering the conventional justification of this recent phenomenon as being “teamwork”, history tells us that this may well be academic double-speak. One precedent was the protracted tussle some 300 years ago between organised medicine and apothecaries, who were to eventually evolve into the progenitors of general practitioners.2 More recently, there have been well documented instances of physician assistants establishing independent practices in the United States.3 One could say that the very title of my editorial seems to have mesmerised Brooks and Mitchell, who have fixated on its seeming bias, ignoring the editorial’s subsequent exploration of current workforce issues in the delivery of quality health care and the urgent plea for the profession to have an evidence-driven debate. On the other hand, it is easy to appreciate their sensitivity to the phrase “doctor displacement”, given their ongoing commitment to the University of Queensland’s postgraduate physician assistant training program.

Martin B Van Der Weyden

To the Editor: Isoniazid is used extensively for the treatment of active and latent tuberculosis (TB). It is generally well tolerated by children, and hypersensitivity reactions resulting in skin rash and requiring cessation of treatment are rarely reported in this age group.1,2 We report a case of isoniazid hypersensitivity in a 21-month-old boy potentially exposed to TB in a childcare setting. He was one of over 80 children screened after contact with a childcare worker who showed a positive smear result. His initial tuberculin skin test (TST) was negative and, in line with New South Wales guidelines,3 he was commenced on isoniazid 150 mg daily (10mg/kg/day) while awaiting a repeat TST. After 3 days of treatment, he developed a small number of round vesicular lesions on his tongue. They were associated with mild discomfort but his appetite was not affected. There were three small maculopapular lesions on his legs and back that reportedly looked like mosquito bites before blistering. The child remained afebrile and was systemically well. The family general practitioner considered that this presentation was possibly an allergic reaction and isoniazid was discontinued. Population health staff were consulted, and the risks and benefits of further isoniazid treatment were discussed with paediatric TB specialists. It was recommended that, after the rash had resolved, isoniazid be reintroduced at half the dosage and with close supervision. Two days after isoniazid 75 mg daily was recommenced, the rash recurred. The child’s mother described lesions appearing as “burns all over his tongue” and reported further sores around his lips and six welt-like lesions on his legs. Isoniazid was immediately discontinued, the skin lesions resolved within 5 days and no further antituberculous therapy was administered. His repeat TST 12 weeks after the initial test was negative and he remains well. No other potential triggers for a hypersensitivity reaction were identified. In particular, no other medications were administered during this period or for the week before commencing isoniazid. According to his mother, the child had experienced a similar reaction within 1 hour of a single dose of ibuprofen when he was 8 months old. Several tongue blisters were accompanied by a generalised fine maculopapular rash lasting several days. We concluded that the child most likely had a hypersensitivity reaction to isoniazid that required discontinuation of treatment. We reported this to the Therapeutic Goods Administration, which advised that it had received seven other reports since 1991 of suspected hypersensitivity, but none were for children under 10 years of age.

Tony D Merritt · Peter D Massey

To the Editor: Accidental asphyxia in very young children is an ongoing problem caused by hazardous sleeping environments and toddlers’ inability to understand dangers or to physically extricate themselves once entrapped. Two common problems involve children becoming wedged between mattresses and cot sides or walls, and hanging from clothing caught on projections inside cots.1 Autopsy in such cases requires careful death scene evaluation to prevent confusion with sudden infant death syndrome and to identify any evidence of inflicted injury, if present. National legislation requiring both new and second-hand cots to meet Australian safety standards has reduced the numbers of unsafe cots on the market. I report a case of another continuing, albeit less common, circumstance that is also resulting in lethal outcomes for toddlers — about one child dies every 1–2 years in Australia in this manner.2 A healthy 13-month-old boy was placed in his cot next to a window with blinds from which a cord was hanging. A loop of the cord measuring about 10 cm was hanging inside the cot. When checked later, the boy was found unresponsive, hanging from the cord. Resuscitation attempts were to no avail. At autopsy, a parchmented ligature mark was present around the neck, with facial and conjunctival petechiae. There were no other injuries or significant illnesses present. Death was therefore attributed to accidental hanging. (Further information on this case is available in the Finding of Inquest.3) Prevention of such tragic fatalities requires ongoing public awareness campaigns, using pamphlets such as the Australian Government’s blind and curtain cords safety alert brochure,2 to advise parents and child carers to keep cots and furniture that can be climbed on away from windows that have curtain or blind cords, to use cleats and cord wind-ups to keep cords at least 1.6 m above the floor, to cut loops, and to keep cords that must be looped under tension with tie-down devices. A safety tassel is also available that clips the two ends of a cord together but that easily separates when put under pressure.4 In addition, national legislation similar to that currently enacted in New South Wales and other states would provide uniform guidelines for managing these devices that would include warning labels and written safety information for parents.4

Roger W Byard