Environmental health

In reply: The response of Chapman to my article is not surprising, given his involvement in the Alpert article.1 The recommendations of Alpert and colleagues have already been criticised internationally, and debate on the effectiveness of pharmacological smoking cessation therapies is not new. Meta-analyses have shown 50% to 70% greater quit rates for nicotine replacement therapy (NRT) compared with placebo or in controls.2,3 Advocates of ...

Johnson George

Objectives: To document the prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae in the refugee population settling in Western Australia from 1 January 2006 to 31 December 2009 and make recommendations for future screening for chlamydia and gonorrhoea in the refugee population.Design and participants: A prevalence and quality assurance study of 2610 refugees aged 15 years and older who attended the Humanitarian Entrant Health Service in Western Australia ...

Veronica C Hoad MB BS, MPH · Aesen Thambiran MB BS, FRACGP

To the Editor: Recent studies have highlighted the safety of administering influenza vaccine derived from embryonated chicken eggs to egg-allergic individuals,1-3 as long as the vaccine contains no more than 1 g of egg ovalbumin per dose. This is reflected in recommendations by expert advisory groups including the Australasian Society of Clinical Immunology and Allergy.4 These recommendations have been strengthened by further evidence of the safety ...

Raymond J Mullins · Michael S Gold

In this issue, Handelsman (doi: 10.5694/mja11.11277) describes changes in the patterns of testosterone prescribing in Australia from 1992 to 2010. He reports that there has been at least a twofold increase in total expenditure on prescriptions, taking into account inflation and population growth, and the increase in expenditure is greater than the increase in prescribing. Yet, ...

Annette Katelaris MB BS, MPH, FRACGP

While the government’s implementation of the National Bowel Cancer Screening Program remains stalled, Australians are dying unnecessarilyOne in 12 Australians will develop colorectal cancer (CRC), and it is the second most common cause of cancer death. It is one of only three cancers for which organised population screening is recommended, and it is the first to ...

Ian N Olver MD, PhD, FRACP · Graeme P Young MD, FRACP, AGAF

A very public slanging match has arisen between The Lancet and one of Australia’s most high-profile medical opinion leaders in psychiatry. The Lancet’s editor, Dr Richard Horton, has queried whether or not Professor Ian Hickie, of ...

Annette Katelaris MB BS, MPH, FRACGP

Reconsidering the place of disease monitoring after treatmentWomen who have completed primary chemotherapy for ovarian cancer commonly have serial assessment of the serum tumour marker cancer antigen 125 (CA-125).1 This practice has been based on the ...

Paul Harnett MB BS(Hons), FRACP, PhD · Ian H Kerridge BMed(Hons), FRCPA, FRACP · Christopher F C Jordens BA(Hons), MPH, PhD · Kim Hobbs BSocStud(Hons) · Catherine Mason MB BS, MPH, FRANZCP · Bronwen M Morrell BA(Hons)

Pain, and, in particular, chronic pain, is older than medicine itself, and a major reason why people see doctors. It is central to human experience, and pervasive in clinical practice. However, pain — and patients in pain — are not well understood or managed. Our lack of understanding of pain mechanisms ...

Annette Katelaris MB BS, MPH, FRACGP

To the Editor: A “real world” study of smoking abstinence caught the attention of Australian media recently, who primarily focused on the commentary that “cold turkey” was the most successful approach for quitting smoking. Alpert and colleagues1 assessed the effects of nicotine replacement therapy (NRT) alone and/or in combination with behaviour counselling in 787 adult smokers from Massachusetts who had recently quit smoking. The participation rates at baseline and waves 2 and 3 were 46%, 56% and 68%, respectively. At each follow-up, almost one-third of participants reported that they had relapsed. Relapse rates were similar, regardless of NRT participation. This contradicted the higher quit rates seen with groups given NRT compared with the placebo or control groups reported in meta-analyses.2-4 Among previously heavy smokers, the lowest relapse rate was in those who received NRT and counselling; and among previously light smokers, the relapse rate was the lowest among those who did not receive NRT or counselling. In both groups, those who received only NRT had the worst relapse rates, a finding which reinforces the importance of adjunct counselling. Participants in the Alpert et al study1 self-reported NRT use. Quit status was not validated biochemically, which fails the Russell Standard5 of criteria applied to smoking cessation trials. Information on NRT dose, adherence, administration technique and reasons for shorter courses (eg, side effects, cost or perceived lack of benefit) were lacking. The longer term impact of NRT cannot be deduced from this study. The quality and quantity of psychological support received by each participant group was also unknown. It is unclear whether the study was adequately powered, given the small numbers of patients who completed a recommended course of NRT. Moreover, differential loss to follow-up threatens the study’s internal validity. Multiple attempts are often necessary before a smoker can successfully quit. Repeated yearly access to courses of NRT, as allowed under the Pharmaceutical Benefits Scheme (a 12-week supply of patches is allowed each year for clients entering a comprehensive smoking cessation support program), may confer a benefit in the longer term. There is no evidence for the effectiveness of cold turkey cessation, especially in moderate to heavy smokers. Nevertheless, those determined to quit without pharmacotherapy or additional support should be encouraged to try cold turkey cessation.

Johnson George

Objectives: To document and describe outpatient persistent pain management services in Australia.Design, participants and setting: Systematic survey conducted between 1 December 2008 and 31 January 2010 of 57 services providing outpatient care to adult clients with persistent pain, plus five specialised paediatric services throughout Australia.Main outcome measures: Service structure, including funding processes; activity, including client numbers, access to specialised services (inpatient care, pain relief interventions); waiting times; and use of allied-health-professional-based pain management programs.Results: Of 68 services identified, 57 participated in the study. The median waiting time from referral receipt to initial clinical assessment for a publicly funded outpatient adult pain management service was 150 days, compared with 38.5 days for a privately funded service (P < 0.05). There was substantial variability among providers in range of services offered, including provision and duration of allied-health pain management programs. The level of service provision for children and rural patients is notably lower than that reported for urban adult constituents.Conclusions: Persistent pain management services are currently unable to meet service requirements adequately, and waiting times are more prolonged for publicly funded than privately funded services. Greater service provision is required in rural areas and for children.

Malcolm N Hogg MB BS, GrDip(PM), FFPANZCA · Stephen Gibson BBSc, PhD · Amal Helou BHlthSc(Nursing), MM(PM) · Jacklyn DeGabriele BHlthSc(Nursing), GrDip(Midwifery) · Michael J Farrell BAppSc(Phty), MSc(Gerontology), PhD

Objective: To describe values of serum prostate-specific antigen (PSA) in older men without diagnosed prostate cancer, categorised by age and country of birth, and to describe self-reported prostate cancer screening. Design, participants and setting: A cohort study (the Concord Health and Ageing in Men Project) involving a representative sample of 1434 eligible ...

Melisa J Litchfield BAppSc, MPH(Hons) · Robert G Cumming MB BS, MPH, PhD · David P Smith BA, MPH, PhD · Vasi Naganathan MB BS, FRACP, PhD · David G Le Couteur FRACP, PhD · Louise M Waite MB BS, FRACP, PhD · Fiona M Blyth MB BS(Hons), FAFPHM, PhD · David J Handelsman MB BS, FRACP, PhD

Recent federal trade policy commitments could protect Australia’s tobacco control legislation and the Pharmaceutical Benefits Scheme in the Trans-Pacific Partnership Agreement negotiations In its Trade Policy Statement of April 2011, the Australian Government committed to “preserve the right of Australian governments to make laws in important public policy areas” and to reject provisions in trade agreements that could “limit its capacity to put health warnings or plain packaging requirements on tobacco products or its ability to continue the Pharmaceutical Benefits Scheme”.1 One forum in which this resolve is likely to be tested is the Trans-Pacific Partnership Agreement (TPPA) negotiations. The TPPA is a proposed regional free trade agreement between Australia, Brunei, Chile, Malaysia, Peru, Singapore, New Zealand, the United States and Vietnam — a diverse assortment of countries from several continents around the Pacific rim. The TPPA differs from existing bilateral and regional free trade agreements in its sheer size and geographic diversity. It has the potential to restrict national policy space — “the freedom, scope and mechanisms that governments have to choose, design and implement public policies to fulfil their aims”2 — on an unprecedented scale. This article explores the potential for the TPPA to constrain Australia’s national health policy space through two illustrative case studies: tobacco plain packaging and the Pharmaceutical Benefits Scheme (PBS). Investor–state dispute settlement and plain packaging of tobacco productsDuring 2011, the Australian Government introduced legislation requiring tobacco products to be packaged in plain paper (with graphic health warnings, but minimal branding). This represents an important assault on one of the last bastions of tobacco marketing — the appeal to personal identity.3 Strong tobacco control policies such as Australia’s tobacco plain packaging laws are consistent with a substantial body of scientific literature and the World Health Organization’s Framework Convention on Tobacco Control, but they can be challenged under international trade and investment agreements, which are driven by economic rather than public health goals. Philip Morris Asia (PMA) — a subsidiary of Philip Morris International (PMI) — has launched an investor–state dispute against the Australian Government over its tobacco plain packaging legislation. While several tobacco companies have taken their complaints to the High Court, PMA has also been able to pursue its case in international arbitration (where it has a greater chance of success) through an investor–state dispute settlement (ISDS) clause in a bilateral investment treaty signed between Australia and Hong Kong in the early 1990s. This is the second investor–state dispute to arise over tobacco labelling; PMI is bringing a similar case against Uruguay through a Swiss subsidiary.4 PMI has also been prominent in calling for an ISDS provision in the TPPA.4,5 Ironically, the corporate restructuring that has allowed PMI to access the Hong Kong bilateral investment treaty (PMA was made the sole shareholder in Philip Morris Australia in February 2011) has also significantly weakened its claims. This is because the investment was made with the company’s full knowledge that the plain packaging legislation was being developed.6 The government has a strong case. Nevertheless, the dispute with PMA highlights broader problems of including ISDS provisions in trade treaties, and demonstrates why it is important that they be excluded from the TPPA. The arbitration rules that govern PMA’s dispute with the Australian Government are those of the United Nations Commission on International Trade Law. The case will be decided by a tribunal made up of three members: one chosen by PMA, one chosen by Australia, and a third, mutually agreed upon, which will act as president. This method of appointing arbitrators has been described as neither independent nor impartial.7 In sharp contrast to domestic forms of adjudication, individuals can serve as a legal representative in one ISDS case and an arbitrator in another, further undermining their ability to act without bias. Furthermore, although the arbitrators will be experts in international investment law, they may have little or no experience with specific fields of public policy such as tobacco control. While the public has a stake in investor–state disputes, confidentiality is a dominant principle in investment arbitration. Hearings are rarely opened to the public unless both parties agree, and investors have opted for closed hearings in several recent cases concerning public policy. In this regard, it is commendable that the Australian Government has adopted a high standard of transparency in advance of the commencement of formal proceedings by posting PMA’s claims and their response on a public website.8 The arbitration will be expensive for Australian taxpayers, although the government may be able to recoup some of the costs if it prevails. In several investor–state disputes to date, legal fees alone have amounted to over US$4 million and in one case have exceeded US$13 million.9 There are also arbitrator’s fees, administration fees and additional costs for involving experts and witnesses. Even more significant are the awards in investor–state cases, which are widely enforceable.7 The Czech Republic was obliged to pay more than US$350 million in compensation to a Dutch investor, which according to one report meant a near doubling of the country’s public sector deficit.10 It can readily be seen how insertion of a TPPA ISDS mechanism into Australia’s national health policy space might skew legislation away from the public interest towards supranational corporate interests. This is why it is significant that the government has vowed to no longer include provisions on ISDS in the bilateral and regional trade agreements that it signs.1 Australia’s refusal to consent to ISDS in the TPPA is a significant step towards limiting the encroachment of international trade agreements into our national health policy space and retaining our sovereign right to regulate significant areas of public health policy. US proposals for medicines policy in the TPPAChallenges to Pharmaceutical Benefits Advisory Committee processesThe PBS is another area of domestic health policy that the Australian Government has committed to protect in international trade agreements. However, US TPPA negotiators are seeking substantial changes to Australia’s laws and administrative processes. Certain draft TPPA provisions relate to the PBS directly and also indirectly, by seeking to prolong pharmaceutical patents and minimise exceptions to them made in the public interest. We examine these proposals as another instance of how the TPPA may promote incursions into our national health policy space. In October 2011, a draft annex to the transparency chapter of the TPPA was leaked.11 Under the rubric of transparency and procedural fairness, this TPPA annex seeks to impose new restrictions on the operation of national pharmaceutical reimbursement and pricing schemes (Box 1). It is an annex because it is not designed to apply to the US, as it would if it was in the body of the treaty. Clause (d) of paragraph X.3 of the draft annex would require countries to reimburse pharmaceutical companies based on “competitive market-derived prices in the Party’s territory”, or other benchmarks that “appropriately recognize the value” of the patented product. This wording represents a shift away from the more science-based standard in Annex 2-C of the Australia–United States Free Trade Agreement (AUSFTA), which refers to the “objectively demonstrated therapeutic significance” of the new patented pharmaceutical (http://www.dfat.gov.au/fta/ausfta/final-text). This provision includes no mechanism for proving that prices are derived from “competitive” markets. It undermines the world-class science-based mechanisms used by the Pharmaceutical Benefits Advisory Committee (PBAC) to determine whether a new patented medicine has sufficient health innovation to be listed on the PBS (based on a determination of cost-effectiveness, as well as efficacy, quality and safety). Paragraph X.3 of the draft annex seeks to impose a new independent appeals process on determinations by government bodies such as the PBAC (Box 1). This is contrary to what was decided (after prolonged and acrimonious negotiations) under Annex 2-C of the AUSFTA, which only provides for independent expert review as a quality improvement exercise for the PBAC. The threat and the use of an independent appeals process would increase the capacity of the pharmaceutical industry to lobby against PBAC decisions and undercut their expert-informed determinations. Paragraph X.4 of the draft annex requires parties to permit pharmaceutical companies to disseminate information to health professionals and consumers via the internet — a practice that is not permitted for prescription drugs in Australia due to concerns about overprescribing. This is also contrary to Annex 2-C of the AUSFTA, which makes the direct advertising of pharmaceuticals subject to Australia’s domestic laws, regulations and procedures. There is a consensus against such advertising in the Australian national policy space, chiefly because of its capacity to increase lobbying of the medical profession for purposes of corporate gain rather than public health benefit. While the effect of US TPPA proposals on Australia’s PBS would be economically damaging and reduce the affordability of medicines in Australia, the effects on access to medicines in other TPPA countries could be far more severe, particularly for developing countries and those required to make greater changes to their domestic laws.12 Extending intellectual property rightsUS TPPA proposals on intellectual property applying to patents13,14 (Box 2) would also add to the cost of medicines overall, affecting the sustainability of the PBS. Non-government organisations have undertaken extensive analyses of these proposed provisions,12,15 and have shown areas where TPPA provisions extend patent protection beyond comparable AUSFTA patent provisions and existing Australian law.15 For example, proposed article 8.1 of the intellectual property (IP) chapter of the TPPA provides patent protection for new forms, uses or methods of using a known product, whereas article 17.9.1 of the AUSFTA does not require patent protection to be provided for new forms of existing drugs.15 Although, in practice, new forms are sometimes patented, the TPPA proposals would restrict efforts to tighten patenting standards in future. Proposed IP article 8.2 requires patenting of diagnostic, therapeutic and surgical methods, whereas article 17.9.2 of the AUSFTA allows for its exclusion.15 This change could restrict expeditious patient access to new clinical developments and substantially add to health care costs. Proposed IP article 8.7 would also eliminate pre-grant opposition to patent applications by third parties, a safeguard provided for in the Australian Patents Act 1990, which is designed to prevent unwarranted patents from being granted.15 Most concerning are the provisions for data exclusivity periods — where generic manufacturers cannot use clinical trial data to prepare and register their products for springboarding after patent expiry. Proposed IP article 9.214 provides an additional 3 years of data exclusivity for new uses of existing pharmaceutical products, on top of the 5 years of data exclusivity already permitted under article 17.10.1 of the AUSFTA. There is also a placeholder for specific provisions for biologics (medicines produced from biological products, which are not currently dealt with separately in Australia). US pharmaceutical companies are reportedly lobbying for 12 years of data exclusivity for biologics. If adopted, these proposals would lead to higher costs to the PBS (as drugs stay under patent for longer periods) and delayed entry of cheaper generic medicines into the market. The US TPPA proposals for extended intellectual property rights and data exclusivity for pharmaceutical companies would require changes to Australian laws and administrative processes. They would also conflict with the spirit of the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, which is currently before the Senate and seeks to raise patent standards and facilitate faster regulatory approval for generic medicines. ConclusionRecent Australian trade policy commitments to exclude ISDS and provisions that would affect the PBS from the TPPA are a positive step towards preserving sovereign, democratic and science-based control over our national health policy space. It is important that Australia continues to insist that future trade agreements, including the TPPA, do not extend the intellectual property privileges of patent holders, interfere with the operation of the PBS or provide foreign corporations with ISDS rights to challenge domestic public health policies. 1 Leaked United States demands for changes to schemes such as Australia’s Pharmaceutical Benefits Scheme Pharmaceutical Benefits Advisory Committee (PBAC) recommendations to be based on competitively derived market forces or systems that appropriately value patented pharmaceuticals (no mention of “objectively derived therapeutic significance” as in the Australia–United States Free Trade Agreement) Appeals process able to challenge PBAC recommendations Heightened capacity for direct-to-patient pharmaceutical advertising 2 Some United States proposals for extensions to intellectual property rights applying to patents Patent protection for new forms of existing drugs Patenting of diagnostic, therapeutic and surgical methods Elimination of pre-grant opposition Extensions to data-exclusivity periods for some drugs

Deborah H Gleeson BSc(MLS), MPH, PhD · Kyla S Tienhaara PhD · Thomas A Faunce BA LLB(Hons), BMed, PhD

Objective: To estimate the number of cancers to be diagnosed in 2025 that could be prevented solely due to changes in diet and physical activity.Design and setting: We used an Australian population-based cancer database to estimate the total number of cancers to be diagnosed in 2025, by applying published age- and sex-specific population projections to current cancer incidence rates, and multiplying the projected numbers of cancers by estimates of population-attributable fractions.Main outcome measures: Projected number of preventable cancers that would be diagnosed in 2025.Results: Our projections suggest that there will be about 170 000 Australians diagnosed with cancer in 2025. This represents an increase of about 60% on the 2007 incidence. Almost 43 000 of these cancers (low estimate, 42 295; middle, 42 657; high, 43 990) could be prevented through improvements to diet and physical activity levels, including through their impact on obesity. It is likely that this is an underestimate of the true figure. The most preventable cancer types in 2025 were estimated to be bowel cancer and female breast cancer (10 049 and 7273 preventable cases, respectively).Conclusions: About 25% of cancers, or about 43 000 cancers in 2025, can potentially be prevented through improvements in diet and physical activity. It is imperative that governments, clinicians and researchers act now if we are to reduce the significant future human and financial burden of cancer.

Peter D Baade PhD · Xingqiong Meng PhD, MD · Craig Sinclair MPPM, BEd · Philippa Youl MPH

We report the first human case of babesiosis in Australia, thought to be locally acquired Clinical recordA 56-year-old man with serious hepatic, renal and bony injuries was transferred to Canberra Hospital in mid November 2010 following a motor vehicle accident. His medical history included type 1 diabetes mellitus, excessive alcohol and prescription medicine use, depression, hypertension and hypercholesterolaemia. He had no history of injecting drug use. He had been living on the south coast of New South Wales with his son. During the first 4 months of his admission he required surgery, prolonged broad-spectrum antibiotic therapy and total parenteral nutrition. He developed worsening cholestatic liver function, moderate-to-severe thrombocytopenia and fluctuating anaemia. By late March 2011, he was pancytopenic with worsening anaemia due to intravascular haemolysis, lymphopenia and severe thrombocytopenia, and required ongoing blood product transfusions. The result of an HIV test was negative. In early April, the patient was transferred to the intensive care unit because of respiratory and haemodynamic deterioration. On 10 April, intraerythrocytic parasites were incidentally identified during routine examination of blood films taken that morning. Ring-form parasites, initially thought to be a Plasmodium species, were confirmed on thick and thin films. Results of immunochromatographic tests were negative for Plasmodium falciparum; however, intravenous artesunate and primaquine therapy for presumed severe malaria was commenced. Broad-spectrum antibiotic therapy was continued. After 48 hours without clinical improvement, the parasitaemia level had increased from 1.7% to 2.6% infected red blood cells. Re-examination of the blood films and recognition that the organisms did not produce hemozoin led to the presumptive diagnosis of babesiosis infection. This was confirmed by Australian and overseas experts who viewed electronic files of the slides. The patient was then given intravenous quinine (600 mg 8-hourly) and clindamycin (600 mg 6-hourly) for babesiosis. Azithromycin and tigecycline were also added to provide additonal broad-spectrum antimicrobial cover, but clinical deterioration continued, and the levels of parasitaemia, anaemia and thrombocytopenia did not improve. He developed multiorgan failure and required haemodialysis. The parasitaemia peaked at 5.1% infected red blood cells despite ongoing blood transfusions (including 18 units of packed red cells over 8 days). As his condition was too unstable for him to undergo total red cell exchange, an exchange of 500 mL of blood was performed on 16 April. He did not recover from the multiorgan failure, and severe thrombocytopenia contributed to acute gastrointestinal bleeding. On 18 April — 5 days after commencing specific antibabesiosis therapy — he suffered a fatal asystolic arrest. Following the patient’s death, a retrospective study of the blood films taken during his hospital admission was undertaken. Ring-form parasites were detected in very low numbers back to the end of the first week of March 2011, coinciding with the development of severe thrombocytopenia. Initially, the multiple blood products that the patient received during his admission were thought to be the likely cause of his babesiosis. But blood films stored by his local pathology service and taken between September and November 2010 (ie, before his hospital admission) revealed pre-existence of the intraerythrocytic parasite and hyposplenic features. As the patient had not received blood products before his hospital admission in November 2010, the parasitaemia could not have been transfusion related. He had reported being bitten by ticks, but had been too sick to qualify this further. Due to general ill health, he had not worked or left the local area for many years. His only overseas travel had been to New Zealand almost 40 years earlier, a country with no known human babesiosis. It thus seemed unlikely that the babesiosis was acquired from overseas. The patient had lived on the south coast of New South Wales for over 30 years — on a small farm with two horses and two Staffordshire bull terriers for 25 years, and then at a house in a small town with his son and a new Staffordshire bull terrier (acquired from within Australia) for 8 years. The new Staffordshire bull terrier was their only pet and was still living at their south coast home in mid 2011. Both his son (who was asymptomatic) and his Staffordshire bull terrier underwent testing for babesiosis; the results were negative. To identify the organism and further elucidate its source, blood samples and films from the patient were examined at the Centers for Disease Control and Prevention (CDC) in Atlanta, United States, and at the School of Veterinary and Biomedical Sciences, Murdoch University, Western Australia. Both laboratories agreed that the morphological characteristics of the parasites in the blood films were consistent with a small Babesia. Intraerythrocytic organisms were mostly single and measured 1.5–2.5 m in size but were highly polymorphic; pyriform and ovoid forms predominated, bizarre amoeboid forms were also common, and an occasional tetrad (Maltese cross form) was noted (Box 1). Immunofluorescent antibody testing for Babesia microti was performed by the CDC on serum samples from the patient (positive result, with titre of 1 : 256) and his son (negative result). Complete sequencing of the 18S ribosomal RNA gene (18S rDNA) and partial sequencing of the β-tubulin gene (both amplified by polymerase chain reaction) confirmed that the organism in the patient’s blood was B. microti. At the CDC, a nested PCR that specifically amplifies a 154-base-pair fragment from the B. microti 18S rDNA was initially used to confirm the presence of B. microti in the patient’s blood. In addition, sequencing of a 1767-base-pair fragment amplified with primers Crypto FL (5'-AACCTGGTTGATCCTGCCAGTAGTCAT-3') and Crypto RN (5'-GAATGATCCTTCCGCAGGTTCACCTAC-3'), was performed to strengthen the PCR findings.1 The 18S rDNA sequence obtained was 100% similar to the GenBank entry AY693840 obtained from a B. microti isolate 18S rDNA gene. At Murdoch University, two nested sets of universal piroplasm 18S rDNA primers were used, one of which has been published.2 The patient’s son’s blood was used as a negative control. The consensus sequence was 100% homologous to known human-derived Babesia species isolates. In addition, five novel primer sets designed during this study were used to obtain a partial β-tubulin gene fragment (791 base pairs), which confirmed the presence of B. microti in the patient’s blood and showed 100% homology with North American isolates (eg, GenBank entries AB083377 and AY144722). A phylogenetic tree for this locus (produced using the maximum likelihood method) revealed clustering with isolates of B. microti obtained from the tick species Ixodes scapularis (formerly known as Ixodes dammini), humans and voles in North America. DiscussionTo our knowledge, this is the first report of a human case of babesiosis in Australia, which we believe was locally acquired. Human babesiosis is an emerging tick-borne zoonosis. The first human case was reported in Croatia in 1957.3 In 1968, Babesia divergens was identified as the cause of human babesiosis in Europe; this was soon followed by the discovery of human cases of B. microti infection in the US.4 More recently, human cases of babesiosis have emerged from Asia, Africa and South America.5-8 Since B. microti has never been detected in Australia before, its discovery as the cause of infection in this patient, who had no significant history of travel, raises intriguing questions about its natural hosts and epidemiology on this continent. Traditionally, B. microti is considered to have a Holarctic distribution, associated with a variety of small mammalian hosts (rodents, including voles, and shrews), and is transmitted by several Ixodes tick species present throughout the northern hemisphere, with humans becoming infected as accidental hosts. Recent phylogenetic analyses based on complete sequences of the genes encoding 18S ribosomal RNA, β-tubulin and the η subunit of the chaperonin-containing t-complex polypeptide 1 suggest that B. microti represents a genetically diverse species complex that comprises several geographically distinct clusters located in North America, Eurasia and Japan, and is closely related to “Babesia microti-like” species isolated from an ever-expanding range of feral and domesticated mammal hosts.9 In Australia, babesiosis is a well documented disease of cattle (Babesia bigemina and Babesia bovis) and dogs (Babesia canis, Babesia vogeli and Babesia gibsoni), and babesiosis tick vectors have been imported to the continent since European settlement.10,11 Australia also has a diverse variety of native Ixodes ticks, including Ixodes holocyclus (responsible for tick paralysis), and a few Babesia and Theileria species have been described morphologically in native marsupial hosts (but not B. microti).12 Unfortunately, a paucity of molecular studies means that the taxonomy and phylogenetic relationships of the endemic piroplasms (intraerythrocytic tick parasites, including Babesia and Theileria) are not well understood. Based on phylogenetic analysis, the isolate from this patient was most closely related to North American strains of B. microti, so it is unlikely that the piroplasm described here originated from a native Australian mammal, but not impossible. In the absence of transfusion or injecting drug history, the patient must have become infected following a tick bite. Two scenarios seem probable. The patient might have been bitten by an imported tick (contained within clothing or luggage that had recently arrived from an endemic country), but no history suggested such contact. Alternatively, a local tick might have transmitted an autochthonous infection, presumably originating from one or more species of introduced rodent. The natural history of this patient’s infection is notable. Babesia ring forms were detectable on routine blood films taken while he was an outpatient — 7 months before he died. At that time, he was asymptomatic and neither anaemic nor thrombocytopenic, but 6 months later the babesiosis became symptomatic and severe. The parasitaemia of 5.1% around the time of his death was likely to have been an underestimate of the true figure as it would have been diluted by the multiple blood products that he was receiving at the time. Asymptomatic parasitaemia is well described in babesiosis, both in the setting of primary infection and following treatment of symptomatic infection.4 It is unclear what transformed this patient’s chronic asymptomatic infection into a severe symptomatic infection that probably contributed to his death. He did have risk factors for severe babesiosis: hyposplenism, liver impairment and his age;4 however, these were present when the infection was asymptomatic months earlier. It is possible that his chronic hospitalisation, and general deconditioning from the long admission, resulted in significant immunosuppression. Severe babesiosis from B. microti is a serious condition with a case fatality rate of 5%–10%.13 Indeed, this patient’s condition did not improve despite his receiving recommended therapy once the diagnosis of babesiosis was made. Even the artesunate that he received for suspected malaria (immediately before the diagnosis) has been shown to have activity against B. microti in animal models.14 Although the animal host for B. microti is yet to be identified in Australia, the proximity of ticks, other wildlife and human populations along Australia’s eastern seaboard means that further cases may be encountered. Clinicians working in Australia should therefore be aware of the signs and symptoms of babesiosis and how to diagnose it (Box 2). Further investigation into the piroplasms of native mammals, introduced rodents and their ticks is necessary to identify the source of this infection. As transfusion-related babesiosis is well recognised in other countries,15 this case may have future implications for the screening of blood products in Australia. 1 Blood film from a 56-year-old man infected with Babesia microti, showing a tetrad form (black arrow) and single ovoid forms (white arrows) Wright stain; original magnification, 3 100. 2 Diagnosing human babesiosis in Australia When to suspect babesiosis Clinicians should suspect babesiosis in patients in Australia who have haemolytic anaemia, thrombocytopenia, fever, an influenza-like illness and a history of at least one of the following: tick bites outdoor activities putting one at risk of tick bites transfusion of blood products overseas travel to a region where babesiosis is endemic. How to proceed with the diagnosis Thick and thin blood films should be examined for intraerythrocytic parasites (three sets of films should be taken, 8–12 hours apart). If the results of blood films are negative but the diagnosis is still suspected, antibody testing of serum and molecular testing of blood (by polymerase chain reaction) can be done.

Sanjaya N Senanayake MB BS, FRACP, MAppEpid · Andrea Paparini MSc, PhD · Maya Latimer MB BS, FRACP, FRCPA · Kerrie Andriolo GradCert (DiagnosticPathology) · Alexandre J Dasilva PhD · Heather Wilson MB BS, PhD · Maniphet V Xayavong BA, MBA · Peter J Collignon MBBS, FRACP, FRCPA · Phillip Jeans MB BS, FRACS · Peter J Irwin BVetMed, PhD, FANZCVSc

To the Editor: A 12-year-old boy presented to a regional emergency department with a 3-day history of progressing bilateral conjunctival injection, fevers (39°C), a widespread erythematous bullous rash, and superficial erosions to his lips, oral mucosa and urethral meatus. The patient was admitted to hospital for management of Stevens–Johnson syndrome (SJS). Initial treatment included intravenous f luids, intravenous ceftriaxone and oral azithromycin before transfer to a tertiary referral hospital. The patient had not taken any oral medications or over-the-counter therapies. He had no preceding viral symptoms. However, 2 weeks before onset of symptoms, he had received vaccination against varicella-zoster virus. On Day 1 of admission, intravenous immunoglobulin (Intragam P, CSL, Melbourne, VIC; batch numbers 3740600696, 3740500668, 3740600690, 3740600679) was administered at a dose of 1 mg/kg and repeated 20 hours later. On Day 2, oral prednisolone therapy (1 mg/kg/day) was initiated and continued for 5 days, and antibiotics were administered for 8 days (cefotaxime [50 mg/kg] and azithromycin [10 mg/kg]). Mycoplasma pneumoniae serological testing of blood samples taken on admission was negative. Bilateral conjunctival ulcers were managed with topical chloramphenicol eye ointment, topical 0.5% prednisone, lubricant drops and normal saline washes. The patient developed further areas of bullae and erosions to his cheeks and ears (Box). He also developed palmar papules, and dusky finger tips and toes. Skin bullous lesions were managed with daily sterile aspiration, and erosions were managed with silver-impregnated silicone dressings (Mepilex Ag, Mölnlycke Health Care, Gothenburg, Sweden). The patient’s rash and fevers abated, and he was discharged on Day 12 with advice from the dietitian and physiotherapy-assisted mobilisation. Sequelae at 2 months included cutaneous post-inflammatory hyperpigmentation. SJS after varicella infection has been reported,1,2 and a single case after varicella vaccination was included in a case series of six possible cases of SJS after vaccinations.3 SJS after medication use or infection with M. pneumoniae is well documented; however, cases where no clear cause can be documented result in increased parental anxiety. This case of SJS was preceded by varicella-zoster vaccination performed as part of school protocol. In the absence of any other obvious cause, it has been reported to alert practitioners of the possibility of a link (Therapeutic Goods Administration adverse drug reaction no. 291111). Patient with Stevens–Johnson syndrome after varicella vaccination

Elizabeth M Christou · Orli Wargon

To the Editor: The prevalence of obesity in Australia is increasing, with a quarter of Australians currently obese and two-thirds overweight.1 The fast-food industry is particularly implicated in this, because it offers cheap, high-calorie and low-nutrient food and employs branding that can alter taste preferences.2 Despite considerable lobbying from health groups, Australian governments have not elected to regulate the fast-food industry, instead leaving it to self-regulate. Predictably, a recent industry self-regulatory initiative aiming to decrease advertising to children failed.3 Suggested methods of regulating the fast-food industry have included taxing unhealthy foods, limiting advertising to children, and mandatory nutritional labelling. However, recent research has suggested a more creative solution. Instead of restricting the industry, perhaps the effective branding strategies of fast-food companies could be used for health promotion. It has been shown that children prefer food in McDonalds-branded wrapping over the identical item in plain wrapping.2 Even typically healthy items, like milk and carrots, are preferred when given McDonalds branding. New research has taken this idea a step further and shown that the branding of a fun, health-themed television show can be used to make healthy foods more appealing.4 These findings may motivate a new population-level strategy to reduce obesity. Established fast-food brands could be given incentives to apply their branding to healthy items. This would allow the fast-food industry to contribute to a healthier food environment, while avoiding the market restriction of taxation. Another option is to establish a government-funded enterprise that uses fast-food marketing to sell healthy items. Costs of such ventures may be outweighed by future reductions in health spending. With regard to obesity, perhaps it is time we started looking on the outside of the box for the solution.

Dugal B S Smith

Objective: To examine the differential in cancer survival between Indigenous and non-Indigenous people in Queensland in relation to time after diagnosis, remoteness and area-socioeconomic disadvantage.Design, setting and participants: Descriptive study of population-based data on all 150 059 Queensland residents of known Indigenous status aged 15 years and over who were diagnosed with a primary invasive cancer during 1997–2006.Main outcome measures: Hazard ratios for the categories of area-socioeconomic disadvantage, remoteness and Indigenous status, as well as conditional 5-year survival estimates.Results: Five-year survival was lower for Indigenous people diagnosed with cancer (50.3%; 95% CI, 47.8%–52.8%) compared with non-Indigenous people (61.9%; 95% CI, 61.7%–62.2%). There was no evidence that this differential varied by remoteness (P = 0.780) or area-socioeconomic disadvantage (P = 0.845). However, it did vary by time after diagnosis. In a time-varying survival model stratified by age, sex and cancer type, the 50% excess mortality in the first year (adjusted HR, 1.50; 95% CI, 1.38–1.63) reduced to near unity at 2 years after diagnosis (HR, 1.03; 95% CI, 0.78–1.35).Conclusions: After a wide disparity in cancer survival in the first 2 years after diagnosis, Indigenous patients with cancer who survive these 2 years have a similar outlook to non-Indigenous patients. Access to services and socioeconomic factors are unlikely to be the main causes of the early lower Indigenous survival, as patterns were similar across remoteness and area-socioeconomic disadvantage. There is an urgent need to identify the factors leading to poor outcomes early after diagnosis among Indigenous people with cancer.

Susanna M Cramb BAppSc(Med Sci), Grad Cert(Sc), MPH · Gail Garvey BEd, MEd · Patricia C Valery PhD, MD, MPH · John D Williamson BA(Hons), GradCert(PublicHlth), MEpi(Clin Epi) · Peter D Baade BSc, MMedSc, PhD

To the Editor: After our recently published article1 and subsequent criticism2 that shortages in benzylpenicillin were a “storm in a teacup”, we would like to detail the increasing number of drug shortages at John Hunter Hospital. Not only does this pose increasing costs to pharmacy but there are escalating threats to patient care. As part of our routine formulary management, records are kept on drug shortages, collected to communicate urgent pharmaceutical issues and not designed as a research tool (Box). All shortages recently experienced in this hospital have been in generic medicines, particularly injectables, although any drug is potentially vulnerable. There are shortages that recur; thiopentone has twice been in short supply in recent months, noradrenaline has had recurrent periods of short supply, and intravenous labetalol is currently critically low and has previously been discontinued by a supplier in Australia, requiring a new manufacturer to be found. At the time of writing, midazolam 5 mg/5 mL injection is in short supply despite there being three generic brands in Australia, suggesting that all products come from the same source. The shortages we are experiencing are similar to but less extensive than those described in the United States.3 However, our list is far from complete as we cannot detect suppliers’ shortages that are resolved before our hospital shelves are affected. Hospitals cope in the usual ways — stockpiling (which protects some networks and harms others), switching to alternatives where possible, and finding new suppliers. Not only does this directly compro-mise patient care, it has been shown that subsequent changes in formulary increase medication errors4,5 — not to mention the economic impact, which is not known in Australia but has been estimated to cost $216 million each year in the US.3 Governments in the US and United Kingdom are taking decisive action to rectify this problem. However, the issue remains unrecognised in Australia and the Therapeutic Goods Administration has indicated to the authors that monitoring shortages is not its legislative responsibility. In the interests of national health care security, this issue needs to be resolved immediately by the federal government. Urgent action must be taken to identify medicines that are “essential” and to safeguard their supply through all possible avenues to ensure short-term health care sustainability. Number of different medicines in short supply at John Hunter Hospital, 2006–2011

Robert Pearce · Simon Quilty · Jacqueline Kewley · Lisa M Harris

There are many challenges in developing evidence-based physical activity guidelines for preschoolers that can ensure health benefits for children.Guidelines for the preschool years have recently been developed in several countries, but there are notable inconsistencies in the amount of physical activity regarded as sufficient for this age group.Given the currently high prevalence of childhood obesity, there is an....

Helen Skouteris PhD · Daniela Dell'Aquila BSocSci(Psych), PostGradDip(Psych) · Louise A Baur BSc(Med), PhD, FRACP · Genevieve M Dwyer MAppSc(Phty), PostgradCert (AdultEd · Marita P McCabe PhD · Lina A Ricciardelli PhD · Matthew Fuller-Tyszkiewicz PhD

To the Editor: In his Opposing Views article, Travis claims that fee- for-service (FFS) “provides the best transparency, accountability and incentive for everyone”.1 However, FFS models reward volume and intensity, rather than quality of outcomes. Evidence suggests that FFS results in increased numbers of patient visits, investigations and procedures,2 which contribute to inflation in the cost of health care.3 Further, an FFS model is “transparent” only on a most superficial level, because doctors are paid for the number of items they deliver. What matters most is transparency about whether the care being delivered to patients is in those patients’ best interests. Patients do not have the same grasp of technical information as their doctors. They assume, with justification, that most doctors perform their clinical practice not primarily to serve their own incomes, but patients’ best interests. Regardless, it is undeniable that the reward structure associated with an FFS system provides powerful incentives for delivering more services, with clinicians subsequently inducing increased demand for medical services.4 On the other hand, the problem with purely salaried providers is that they are more likely to underservice their patients, with an increase in the length and a decrease in the number of consultations.2 Clearly, neither of these payment systems is optimal for driving quality or efficiency in resource use. The ideal outcome from health care reform would be one in which the focus is on delivering high-quality, efficient care to patients, rather than high-quantity care. In designing the optimal payment structure, the aim should be to align the incentive with the quality and appropriateness of the care that is delivered — to reward doctors for their efforts to provide good health outcomes for patients.3 Our current health system provides much lower rewards for the doctors who practise much of our preventive care (general practitioners and physicians) than it does for procedural specialists. This may not be the most cost-effective strategy, and part of the debate about how doctors are paid should be directed at this imbalance. There has been experimentation with “capitation combined with pay-for-performance” or “shared savings” models, which are promising attempts to find the best balance of incentives for cost control and quality improvement.5

Matthew H R Anstey · Stephen P Gildfind