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In a world where sexual and reproductive injustice continues, Australia has been quietly making changes for the better. Australian sexual and reproductive health law reforms have been prodigious in recent years: we have seen more changes in the past six years than in the previous 60. Alongside Australia's progression, however, sexual and reproductive rights have been considerably eroded in other countries. How does the global context of reproductive rights affect Australia? And how can we protect not only our hard‐fought liberties but also ensure they are equitable and clinically fit for purpose?

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MSI Australia, Melbourne, VIC

Correspondence: catriona.melville@msiaustralia.org.au

Competing interests:

No relevant disclosures.

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29. Sifris R. Abortion in Australia: law, policy and the advancement of reproductive rights. In: Ziegler M; editor. Research handbook on international abortion law. Edward Elgar Publishing, 2023; pp. 124‐140.

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Socio‐economic status and access to fluoridated water in Queensland: an ecological data linkage study

Christopher T Sexton, Diep H Ha, Thu Le, Ratilal Lalloo, Pauline Ford, Loc G Do and Nicole Stormon

Med J Aust || doi: 10.5694/mja2.52196
Published online: 22 January 2024

ARTICLE
AUTHORS
REFERENCES

Topics

Environment and public health

Social determinants of health

Abstract

Objectives: To investigate the relationship between access to fluoridated drinking water and area‐level socio‐economic status in Queensland.

Study design: Ecological, geospatial data linkage study.

Setting: Queensland, by statistical area level 2 (SA2), 2021.

Main outcome measures: Proportion of SA2s and of residents with access to fluoridated drinking water (natural or supplemented); relationship at SA2 level between access to fluoridated water and socio‐economic status (Index of Relative Socio‐economic Advantage and Disadvantage, IRSAD; Index of Economic Resources, IER).

Results: In 2021, an estimated 4 050 168 people (79.4% of the population) and 397 SA2 regions (72.7%) in Queensland had access to fluoridated water. Access was concentrated in the southeastern corner of the state. After adjusting for SA2 population, log area, and population density, the likelihood of access to fluoridated drinking water almost doubled for each 100‐rank increase in IRSAD (adjusted odds ratio [aOR], 1.93; 95% confidence interval [CI], 1.59–2.36) or IER (aOR, 1.77; 95% CI, 1.50–2.11).

Conclusions: The 2012 decision to devolve responsibility for water fluoridation decisions and funding from the Queensland government to local councils means that residents in lower socio‐economic areas are less likely to have access to fluoridated water than those in more advantaged areas, exacerbating their already greater risk of dental disease. Queensland water fluoridation policy should be revised so that all residents can benefit from this evidence‐based public health intervention for reducing the prevalence of dental caries.

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1 The University of Queensland, Brisbane, QLD
2 Metro North Hospital and Health Service, Queensland Health, Brisbane, QLD

Correspondence: c.sexton@uq.edu.au

Acknowledgements:

We acknowledge Queensland Health for providing access to the water fluoridation data for this article.

Competing interests:

No relevant disclosures.

1. National Health and Medical Research Council. Water fluoridation: dental and other human health outcomes (NHMRC ref. EH43). July 2017. https://www.nhmrc.gov.au/file/2861/download?token=ATb5PO0f (viewed June 2023).
2. Iheozor‐Ejiofor Z, Worthington HV, Walsh T, et al. Water fluoridation for the prevention of dental caries. Cochrane Database Syst Rev 2015; CD010856.
3. Mariño R, Zaror C. Economic evaluations in water‐fluoridation: a scoping review. BMC Oral Health 2020; 20: 115.
4. Cobiac LJ, Vos T. Cost‐effectiveness of extending the coverage of water supply fluoridation for the prevention of dental caries in Australia. Community Dent Oral Epidemiol 2012; 40: 369‐376.
5. Whelton HP, Spencer AJ, Do LG, Rugg‐Gunn AJ. Fluoride revolution and dental caries: evolution of policies for global use. J Dent Res 2019; 98: 837‐846.
6. Kunzel W, Fischer T, Lorenz R, Brühmann S. Decline of caries prevalence after the cessation of water fluoridation in the former East Germany. Community Dent Oral Epidemiol 2000; 28: 382‐389.
7. McLaren L, Patterson S, Thawer S, et al. Exploring the short‐term impact of community water fluoridation cessation on children's dental caries: a natural experiment in Alberta, Canada. Public Health 2017; 146: 56‐64.
8. Stormon N, Lalloo R. Monitoring the extent of water fluoridation coverage in Australia. Health Promot J Austr 2020; 31: 169‐171.
9. Akers HF, Foley MA. Fluoridation advocacy in Queensland: a long and winding road. Int Dent J 2012; 62: 262‐269.
10. Queensland Parliament. South East Queensland Water (Restructuring) and Other Legislation Amendment Act 2012 (Act No. 39 of 2012). https://documents.parliament.qld.gov.au/bills/2012/2584/12AC039‐4aa2.pdf (viewed Aug 2023).
11. Akers HF, Armfield JM. Australian opinions on water fluoridation: do Queenslanders believe differently? J Investig Clin Dent 2010; 1: 65‐73.
12. Head B. Evidence‐based policy: principles and requirements. In: Australian Productivity Commission. Strengthening evidence‐based policy in the Australian Federation. Canberra, 17–18 August 2009. Volume 1: Proceedings. Canberra: Productivity Commission, 2010; pp. 13‐26. https://www.pc.gov.au/research/supporting/strengthening‐evidence/roundtable‐proceedings‐volume1.pdf (viewed June 2023).
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18. Gabardo MC, da Silva WJ, Moyses ST, Moyses SJ. Water fluoridation as a marker for sociodental inequalities. Community Dent Oral Epidemiol 2008; 36: 103‐107.
19. Gabardo MCL, da Silva WJ, Olandoski M, et al. Inequalities in public water supply fluoridation in Brazil: an ecological study. BMC Oral Health 2008; 8: 9.
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The Australian Government's new vaping policy should be part of a larger plan towards a tobacco endgame

Samantha Howe, Driss Ait Ouakrim, Tony Blakely and Coral E Gartner

Med J Aust || doi: 10.5694/mja2.52197
Published online: 22 January 2024

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AUTHORS
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Topics

Environment and public health

Health services administration

The Australian Minister for Health and Aged Care, Mark Butler, made a strong push to address the growing problem of youth vaping in his speech at the National Press Club in May 2023.1 While new approaches to controlling youth vaping are urgently needed, it is critical that policy reforms to end the tobacco cigarette epidemic are also pursued with equal vigour — otherwise we risk shifting people currently using vapes to tobacco smoking. In this article, we argue that Australia should leverage its strong vaping regulation to commit in parallel to an ambitious commercial tobacco endgame to rapidly minimise smoking.

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1 Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC
2 School of Public Health, University of Queensland, Brisbane, QLD

Correspondence: howe.s@unimelb.edu.au

Open access:

Open access publishing facilitated by The University of Melbourne, as part of the Wiley ‐ The University of Melbourne agreement via the Council of Australian University Librarians.

Competing interests:

Coral Gartner is currently funded by the National Health and Medical Research Council (GNT1198301) towards the Centre for Research Excellence on Achieving the Tobacco Endgame (2020–2025). She also receives funding from an Australian Research Council Fellowship (FT220100186) to develop new regulatory options to minimise the legal and illegal tobacco markets (2023–2026). Tony Blakely and Ait Ouakrim were contracted by the Aotearoa NZ Health Ministry (2021–2022) to undertake modelling of the Smokefree Aotearoa 2025 Action Plan.

1. Butler M. Minister for Health and Aged Care – Speech – National Press Club – 2 May 2023. https://www.health.gov.au/ministers/the‐hon‐mark‐butler‐mp/media/minister‐for‐health‐and‐aged‐care‐speech‐national‐press‐club‐2‐may‐2023?language=en (viewed May 2023).
2. Turnbull T. Australia to ban recreational vaping in major public health move. BBC News, 2 May 2023. https://www.bbc.com/news/world‐australia‐65446352 (viewed May 2023).
3. Kirby T. Australia to introduce sweeping e‐cigarette regulations. Lancet 2023; 401: 1557.
4. Therapeutic Goods Administration. Proposed reforms to the regulation of nicotine vaping products: consultation paper. Nov 2022. https://consultations.tga.gov.au/medicines‐regulation‐division/proposed‐reforms‐to‐the‐regulation‐of‐nicotine‐vap/user_uploads/tga‐consultation‐paper‐‐‐nicotine‐vaping‐products‐‐‐nov‐22‐1.pdf (viewed May 2023).
5. Gartner C. How do you solve a problem like youth vaping? Drug Alcohol Rev 2023; 42: 1298‐1300.
6. Butler M. Taking action on smoking and vaping [media release]. 2 May 2023. https://www.health.gov.au/ministers/the‐hon‐mark‐butler‐mp/media/taking‐action‐on‐smoking‐and‐vaping#:~:text=stop%20the%20import%20of%20non,nicotine%20concentrations%20and%20volumes%3B%20and (viewed May 2023).
7. Gartner C, Morphett K, Holland A, et al. Health practitioner experiences of Australia's prescription‐only regulatory model of nicotine vaping products: a qualitative study [abstract]. 29th Annual Meeting of the Society for Research on Nicotine and Tobacco; 1‐4 Mar 2023; San Antonio, TX. https://cdn.ymaws.com/www.srnt.org/resource/resmgr/conferences/2023_annual_meeting/documents/SRNT23_Abstracts022423.pdf (viewed May 2023).
8. Australian Institute of Health and Welfare. National Drug Strategy Household Survey 2019 (Drug Statistics Series No. 32; Cat. No. PHE 270). Canberra: AIHW, 2020. https://www.aihw.gov.au/getmedia/77dbea6e‐f071‐495c‐b71e‐3a632237269d/aihw‐phe‐270.pdf?v=20230605184325&inline=true (viewed May 2023).
9. Australian Institute of Health and Welfare. Australian Burden of Disease Study: Impact and causes of illness and death in Australia 2018 (Australian Burden of Disease Study Series No. 23; Cat. No. BOD 29). Canberra: AIHW, 2021. https://www.aihw.gov.au/getmedia/5ef18dc9‐414f‐4899‐bb35‐08e239417694/aihw‐bod‐29.pdf?v=20230605164208&inline=true (viewed May 2023).
10. Australian Bureau of Statistics. National Aboriginal and Torres Strait Islander Health Survey: statistics about long‐term health conditions, disability, lifestyle factors, physical harm and use of health services. Reference period: 2018–19 financial year. https://www.abs.gov.au/statistics/people/aboriginal‐and‐torres‐strait‐islander‐peoples/national‐aboriginal‐and‐torres‐strait‐islander‐health‐survey/latest‐release (viewed May 2023).
11. Australian Institute of Health and Welfare. Australian Burden of Disease Study: impact and causes of illness and death in Aboriginal and Torres Strait Islander people 2018 (Australian Burden of Disease Study Series No. 26; Cat. No. BOD 32). Canberra: AIHW, 2022. https://www.aihw.gov.au/getmedia/1656f783‐5d69‐4c39‐8521‐9b42a59717d6/aihw‐bod‐32.pdf?v=20230605164213&inline=true (viewed May 2023).
12. Department of Health and Aged Care. National Tobacco Strategy 2023–2030. Canberra: Australian Government, 2023. https://www.health.gov.au/sites/default/files/2023‐05/national‐tobacco‐strategy‐2023‐2030.pdf (viewed May 2023).
13. Puljevic C, Morphett K, Hefler M, et al. Closing the gaps in tobacco endgame evidence: a scoping review. Tob Control 2022; 31: 365‐375.
14. Butler M. Ten years of world‐leading reforms and reigniting the fight against tobacco addiction [media release]. 30 Nov 2022. Canberra: Department of Health and Aged Care, 2022. https://www.health.gov.au/ministers/the‐hon‐mark‐butler‐mp/media/ten‐years‐of‐world‐leading‐reforms‐and‐reigniting‐the‐fight‐against‐tobacco‐addiction?language=en (viewed May 2023).
15. Wade S, Weber MF, Sarich P, et al. Fifty‐year forecasts of daily smoking prevalence: can Australia reach 5% by 2030? Tob Control 2023; https://doi.org/10.1136/tc‐2022‐057624.
16. Greenhalgh E, Bayly M, Jenkins S, Scollo MM. 1.3 Prevalence of smoking—adults. In: Greenhalgh EM, Scollo MM, Winstanley MH, editors. Tobacco in Australia: facts and issues. Melbourne: Cancer Council Victoria, 2021. https://www.tobaccoinaustralia.org.au/chapter‐1‐prevalence/1‐3‐prevalence‐of‐smoking‐adults (viewed May 2023).
17. New Zealand Legislation. Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Act 2022. https://legislation.govt.nz/bill/government/2022/0143/latest/whole.html (viewed May 2023).
18. Ministry of Health. Smokefree Aotearoa 2025 Action Plan. Wellington: New Zealand Government, 2021. https://www.health.govt.nz/system/files/documents/publications/hp7801_‐_smoke_free_action_plan_v15_web.pdf (viewed May 2023).
19. Ait Ouakrim D, Wilson T, Waa A, et al. Tobacco endgame intervention impacts on health gains and Māori:non‐Māori health inequity: a simulation study of the Aotearoa/New Zealand Tobacco Action Plan. Tob Control 2023; https://doi.org/10.1136/tc‐2022‐057655 (online ahead of print).
20. Coalition Agreement: New Zealand National Party & ACT New Zealand. 54th Parliament. 2023. https://assets.nationbuilder.com/nationalparty/pages/18466/attachments/original/1700778592/National_ACT_Agreement.pdf?1700778592 (viewed Dec 2023).
21. Quinlivan M. Nicola Willis admits scrapping smokefree laws will help fund tax cuts in Newshub Nation interview. Auckland: Newshub, 25 Nov 2023. https://www.newshub.co.nz/home/politics/2023/11/nicola‐willis‐admits‐scrapping‐smokefree‐laws‐will‐help‐fund‐tax‐cuts‐in‐newshub‐nation‐interview.html (viewed Dec 2023).
22. Hoek J, Edwards R, Ball J, et al. The smokefree legislation is evidence‐based, removing it is not. Public Health Communication Centre, 30 Nov 2023. https://www.phcc.org.nz/briefing/smokefree‐legislation‐evidence‐based‐removing‐it‐not#:~:text=Yet%2C%20one%20of%20the%20coalition,millions%20of%20health%20care%20dollars (viewed Dec 2023).
23. Hefler M, Malone RE. Short‐term dollars at what cost? Repealing New Zealand's Smokefree Aotearoa 2025 plan would sacrifice lives and longer‐term economic gain. Tob Control 2023; https://doi.org/10.1136/tc‐2023‐058535 (online ahead of print).
24. Secretary of State for Health and Social Care. Stopping the start: our new plan to create a smokefree generation. London: Department of Health and Social Care, United Kingdom Government, 2023. https://www.gov.uk/government/publications/stopping‐the‐start‐our‐new‐plan‐to‐create‐a‐smokefree‐generation/stopping‐the‐start‐our‐new‐plan‐to‐create‐a‐smokefree‐generation (viewed May 2023).
25. Ministry of Health. Annual update of key results 2021/22: New Zealand Health Survey. Wellington: New Zealand Government, 2022. https://www.health.govt.nz/publication/annual‐update‐key‐results‐2021‐22‐new‐zealand‐health‐survey#:~:text=Daily%20vaping%2Fe‐cigarette%20use,and%20Pacific%20peoples (viewed May 2023).
26. Ministry of Health. Proposals for the Smoked Tobacco Regulatory Regime [public consultation document]. Wellington: New Zealand Government, 2023. https://www.health.govt.nz/publication/proposals‐smoked‐tobacco‐regulatory‐regime (viewed May 2023).
27. Parliament of Tasmania. Public Health Amendment (Tobacco‐Free Generation) Bill 2014. https://www.parliament.tas.gov.au/__data/assets/pdf_file/0025/39157/tfg20bill.pdf (viewed Nov 2023).
28. Trainer E, Gall S, Smith A, Terry K. Public perceptions of the tobacco‐free generation in Tasmania: adults and adolescents. Tob Control 2017; 26: 458.
29. US Food and Drug Administration. FDA announces plans for proposed rule to reduce addictiveness of cigarettes and other combusted tobacco products [media release]. 21 June 2022. https://www.fda.gov/news‐events/press‐announcements/fda‐announces‐plans‐proposed‐rule‐reduce‐addictiveness‐cigarettes‐and‐other‐combusted‐tobacco (viewed Dec 2023).

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Providing Australian children and adolescents with equitable access to new and emerging therapies through clinical trials: a call to action

Michelle S Lorentzos, David Metz, Andrew S Moore, Laura K Fawcett, Paula Bray, Lani Attwood, Craig F Munns and Andrew Davidson

Med J Aust || doi: 10.5694/mja2.52191
Published online: 15 January 2024

ARTICLE
AUTHORS
REFERENCES

Topics

Statistics, epidemiology and research design

Pediatric medicine

Health services administration

Opportunities for children to benefit from novel therapies have increased substantially over the past decade. Change is needed to maximise these opportunities, particularly in the paediatric trial environment. Investment and a coordinated national approach are needed to prevent Australian children falling behind their international peers. There is international recognition that collaborative approaches and strategic investment in paediatric clinical trials reap benefits in terms of access to clinical trials and new therapies. This article exemplifies a multi‐state collaboration and presents a united call to action to prioritise paediatric clinical trials, by strategically investing in effective governance and infrastructure, and a shift in culture that embeds clinical trials in the core business of paediatric health care and academic institutions.

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1 Kids Research, Sydney Children's Hospitals Network, Sydney, NSW
2 University of Sydney, Sydney, NSW
3 Monash Children's Clinical Trial Centre, Monash Children's Hospital, Melbourne, VIC
4 Monash University, Melbourne, VIC
5 Child Health Research Centre, University of Queensland, Brisbane, QLD
6 Queensland Children's Hospital, Brisbane, QLD
7 University of New South Wales, Sydney, NSW
8 Sydney Children's Hospitals Network, Sydney, NSW
9 Royal Children's Hospital, Melbourne, VIC
10 Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Melbourne, VIC

Correspondence: michelle.lorentzos@health.nsw.gov.au

Open access:

Open access publishing facilitated by The University of Sydney, as part of the Wiley - The University of Sydney agreement via the Council of Australian University Librarians.

Competing interests:

The Murdoch Children's Research Institute and Sydney Children's Hospitals Network have received funding from Roche to aid in building capacity for gene therapy in Australia. All authors’ hospitals and/or institutions are active sites for pharmaceutical company‐sponsored clinical trials and receive enrolment‐based reimbursement on a trial‐by‐trial basis, but do not receive direct funding for clinical trials capacity or capability building unless stated above.

1. Arabi F, Mansouri V, Ahmadbeigi N. Gene therapy clinical trials, where do we go? An overview. Biomed Pharmacother 2022; 153: 113324.
2. Brown DG, Wobst HJ, Kapoor A, et al. Clinical development times for innovative drugs. Nat Rev Drug Discov 2022; 21: 793‐4.
3. Lederer CW, Koniali L, Buerki‐Thurnherr T, et al. Catching them early: framework parameters and progress for prenatal and childhood application of advanced therapies. Pharmaceutics 2022; 14: 793.
4. Nemeh F, Buchbinder R, Hawley CM, et al. Activities supporting the growth of Clinical Trial Networks in Australia. Trials 2022; 23: 81.
5. Vincent F, Nueda A, Lee J, et al. Phenotypic drug discovery: recent successes, lessons learned and new directions. Nat Rev Drug Discov 2022; 21: 899‐914.
6. Middleton PG, Mall MA, Dřevínek P, et al. Elexacaftor‐tezacaftor‐ivacaftor for cystic fibrosis with a single Phe508del allele. N Engl J Med 2019; 381: 1809‐1819.
7. Davidson JE, Farrar MA. The changing therapeutic landscape of spinal muscular atrophy. Aust J Gen Pract 2022; 51: 38‐42.
8. Alnefaie A, Albogami S, Asiri Y, et al. Chimeric antigen receptor T‐Cells: an overview of concepts, applications, limitations, and proposed solutions. Front Bioeng Biotechnol 2022; 10: 797440.
9. Rare Voices Australia. What is a rare disease? https://rarevoices.org.au/what‐is‐a‐rare‐disease (viewed Oct 2023).
10. European Organisation for Rare Diseases. Rare diseases: understanding this public health priority. Nov 2005. https://www.eurordis.org/wp‐content/uploads/2009/12/princeps_document‐EN.pdf (viewed Oct 2023).
11. Wright CF, FitzPatrick DR, Firth HV. Paediatric genomics: diagnosing rare disease in children. Nat Rev Genet 2018; 19: 253‐268.
12. Janiaud P, Serghiou S, Ioannidis JPA. New clinical trial designs in the era of precision medicine: an overview of definitions, strengths, weaknesses, and current use in oncology. Cancer Treat Rev 2019; 73: 20‐30.
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14. Bogue C, DiMeglio LA, Maldonado S, et al. Special article: 2014 Pediatric Clinical Trials Forum. Pediatr Res 2016; 79: 662‐669.
15. Hirschfeld S, Lagler FB, Kindblom JM. Prerequisites to support high‐quality clinical trials in children and young people. Arch Dis Childhood 2021; 106: 423‐428.
16. Joseph PD, Craig JC, Caldwell PH. Clinical trials in children. Br J Clin Pharmacol 2015; 79: 357‐369.
17. Shakhnovich V, Hornik CP, Kearns GL, et al. How to conduct clinical trials in children: a tutorial. Clin Transl Sci 2019; 12: 218‐230.
18. Greenberg RG, McCune S, Attar S, et al. Pediatric clinical research networks: role in accelerating development of therapeutics in children. Ther Innov Regul Sci 2022; 56: 934‐947.
19. HR 5269: Pediatric Network Support Act. House of Representatives, 118th Congress, 1st Session, 25 Aug 2023. https://www.congress.gov/118/bills/hr5269/BILLS‐118hr5269ih.pdf (viewed Oct 2023).
20. Australian Government Department of Health. National Strategic Action Plan for Rare Diseases. Feb 2020. https://www.health.gov.au/sites/default/files/documents/2020/03/national‐strategic‐action‐plan‐for‐rare‐diseases.pdf (viewed Jan 2023).
21. Australian Commission on Safety and Quality in Health Care. National Clinical Trials Governance Framework and User Guide. Feb 2022. https://www.safetyandquality.gov.au/publications‐and‐resources/resource‐library/national‐clinical‐trials‐governance‐framework‐and‐user‐guide (viewed Jan 2023).
22. Turner MA, Hildebrand H, Fernandes RM, et al. The conect4children (c4c) Consortium: potential for improving European clinical research into medicines for children. Pharmaceut Med 2021; 35: 71‐79.
23. Department of Health. National Health Genomics Policy Framework 2018–2021. Canberra: Commonwealth of Australia, 2017. https://www.health.gov.au/resources/publications/national‐health‐genomics‐policy‐framework‐2018‐2021 (viewed Jan 2023).
24. Directorate‐General for Research and Innovation (European Commission). Interim evaluation of Horizon 2020. European Union, 2017. https://op.europa.eu/en/publication‐detail/‐/publication/fad8c173‐7e42‐11e7‐b5c6‐01aa75ed71a1/language‐en/format‐PDF/source‐77918455 (viewed Jan 2023).
25. Wax PM. Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Ann Intern Med 1995; 122: 456‐461.
26. Sinclair CJ. A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens, by William A. Silverman, et al, Pediatrics, 1956; 18: 614‐624. Pediatrics 1998; 102: 225‐227.
27. Weiss CF, Glazko AJ, Weston JK. Chloramphenicol in the newborn infant. A physiologic explanation of its toxicity when given in excessive doses. N Engl J Med 1960; 262: 787‐794.
28. Robertson AF. Reflections on errors in neonatology: I. The “hands‐off” years, 1920 to 1950. J Perinatol 2003; 23: 48‐55.
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30. Gershanik J, Boecler B, Ensley H, et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med 1982; 307: 1384‐1388.
31. MacDonald MG, Getson PR, Glasgow AM, et al. Propylene glycol: increased incidence of seizures in low birth weight infants. Pediatrics 1987; 79: 622‐625.
32. Bove KE, Kosmetatos N, Wedig KE, et al. Vasculopathic hepatotoxicity associated with E‐Ferol syndrome in low‐birth‐weight infants. JAMA 1985; 254: 2422‐2430.
33. Burckart GJ, Kim C. The revolution in pediatric drug development and drug use: therapeutic orphans no more. J Pediatr Pharmacol Ther 2020; 25: 565‐573.
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35. Ward RM, Benjamin DK Jr, Davis JM, et al. The need for pediatric drug development. J Pediatr 2018; 192: 13‐21.
36. Shaddy RE, Denne SC. Clinical report–guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 2010; 125: 850‐860.
37. Bhatnagar M, Sheehan S, Sharma I, et al. Prospect of direct benefit in pediatric trials: practical challenges and potential solutions. Pediatrics 2021; 147: e2020049602.
38. Liu Q, Ahadpour M, Rocca M, Huang SM. Clinical pharmacology regulatory sciences in drug development and precision medicine: current status and emerging trends. AAPS J 2021; 23: 54.

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Perspectives

Online first

Rationale and plan for a focus on First Nations urban health research in Australia

Janet Stajic, Adrian Carson and James Ward

Med J Aust || doi: 10.5694/mja2.52181
Published online: 15 January 2024

ARTICLE
AUTHORS
REFERENCES

Topics

Health services administration

Social determinants of health

Environment and public health

Indigenous health

Urbanisation is a global phenomenon. The World Health Organization reported in 2015 that 55% of the global population lived in cities and is predicting this to increase to 68% by 2050.1 First Nations peoples globally are disproportionately affected by urbanisation, with major drivers being climate change, deforestation and increased pressures created by globalisation. Despite this, there is limited research to address urbanisation and its impact on human health and wellbeing. Similarly, there is an urgent need for a focus on improving health and wellbeing outcomes for urban First Nations peoples in Australia given the rapid urbanisation of First Nations people.

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1 UQ Poche Centre for Indigenous Health, University of Queensland, Brisbane, QLD
2 Institute for Urban Indigenous Health, Brisbane, QLD

Correspondence: j.stajic@uq.edu.au

Open access:

Open access publishing facilitated by The University of Queensland, as part of the Wiley ‐ The University of Queensland agreement via the Council of Australian University Librarians.

Acknowledgements:

The UQ Poche Centre for Indigenous Health is generously supported by philanthropists Greg Poche AO and Kay Van Norton Poche. We acknowledge Dr Anton Clifford‐Motopi of the UQ Poche Centre for undertaking yarning sessions with members of the Research Alliance for Urban Community‐Controlled Health Services and analysis to inform and develop its research priorities.

Competing interests:

No relevant disclosures.

1. World Health Organization. Setting global research priorities for urban health. Geneva: WHO, 2022. https://www.who.int/publications/i/item/9789240041820 (viewed Mar 2023).
2. Australian Bureau of Statistics. Estimates of Aboriginal and Torres Strait Islander Australians [website]. Canberra: ABS, 2022. www.abs.gov.au/statistics/people/aboriginal‐and‐torres‐strait‐islander‐peoples/estimates‐aboriginal‐and‐torres‐strait‐islander‐australians/latest‐release (viewed Oct 2022).
3. Brand E, Bond C, Shannon C. Indigenous in the city: urban Indigenous populations in local and global contexts. Brisbane: UQ Poche Centre, 2016. www.poche.centre.uq.edu.au/files/609/Indigenous‐in‐the‐city%281%29.pdf 30/03/2023 (viewed Nov 2023).
4. National Indigenous Australians Agency, Australian Institute of Health and Welfare. Life expectancy at birth [website]. Canberra: Commonwealth of Australia, 2021. www.indigenoushpf.gov.au/measures/1‐19‐life‐expectancy‐birth (viewed Nov 2023).
5. National Indigenous Australians Agency, Australian Institute of Health and Welfare. Social and emotional wellbeing [website]. Canberra: Commonwealth of Australia, 2021. www.indigenoushpf.gov.au/measures/1‐18‐social‐emotional‐wellbeing (viewed Nov 2023).
6. National Indigenous Australians Agency, Australian Institute of Health and Welfare. Perceived health status. Canberra: Commonwealth of Australia, 2021. www.indigenoushpf.gov.au/measures/1‐17‐perceived‐health‐status (viewed Nov 2023).
7. National Indigenous Australians Agency, Australian Institute of Health and Welfare. Antenatal care. Canberra: Commonwealth of Australia, 2021. www.indigenoushpf.gov.au/measures/3‐01‐antenatal‐care (viewed Nov 2023).
8. Public Health Information Development Unit (PHIDU). Indigenous potentially preventable hospitalisations; identifying hotspots of inequalities. Adelaide: Torrens University Australia, 2020 https://phidu.torrens.edu.au/social‐health‐atlases/topic‐atlas/indigenous‐pph#pph‐rates‐by‐remoteness‐category (viewed Nov 2023).
9. Kildea S, Hickey S, Nelson C, et al. Birthing on Country (in Our Community): a case study of engaging stakeholders and developing a best‐practice Indigenous maternity service in an urban setting. Aust Health Rev 2018; 42: 230‐238.
10. Kennedy M, Bennett J, Maidment S, et al. Interrogating the intentions for Aboriginal and Torres Strait Islander health: a narrative review of research outputs since the introduction of Closing the Gap. Med J Aust 2022; 217: 50‐57. https://www.mja.com.au/journal/2022/217/1/interrogating‐intentions‐aboriginal‐and‐torres‐strait‐islander‐health‐narrative
11. Eades SJ, Taylor B, Bailey S, et al. The health of urban Aboriginal people: Insufficient data to close the gap. Med J Aust 2010; 193: 521‐524. https://www.mja.com.au/journal/2010/193/9/health‐urban‐aboriginal‐people‐insufficient‐data‐close‐gap
12. Jennings W, Spurling G, Shannon B, et al. Rapid review of five years of Aboriginal and Torres Strait Islander health research in Australia — persisting under‐representation of urban populations. Aust N Z J Public Health 2021; 45: 53‐58.
13. Thomas J, Barraket J, Parkinson S, et al. Australian Digital Inclusion Index: 2021. Melbourne: RMIT, Swinburne University of Technology, and Telstra; 2021. https://researchbank.swinburne.edu.au/file/ab6218ee‐55f3‐4d84‐9174‐76ca9ec877be/1/2021‐thomas‐measuring_australias_digital.pdf (viewed July 2023).
14. UQ Poche Centre for Indigenous Health. Terms of reference: the National Research Alliance for Urban Community‐Controlled Health Services. Brisbane: University of Queensland, 2023.
15. National Health and Medical Research Council. Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: guidelines for researchers and stakeholders. Canberra: Commonwealth of Australia, 2018. www.nhmrc.gov.au/about‐us/resources/ethical‐conduct‐research‐aboriginal‐and‐torres‐strait‐islander‐peoples‐and‐communities (viewed Mar 2023).

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Research

The burden of occupational injury attributable to high temperatures in Australia, 2014–19: a retrospective observational study

Blesson M Varghese, Alana Hansen, Nick Mann, Jingwen Liu, Ying Zhang, Tim R Driscoll, Geoffrey G Morgan, Keith Dear, Anthony Capon, Michelle Gourley, Vanessa Prescott, Vergil Dolar and Peng Bi

Med J Aust 2023; 219 (11): . || doi: 10.5694/mja2.52171
Published online: 11 December 2023

ARTICLE
AUTHORS
REFERENCES

Topics

Environment and public health

Occupational diseases

Abstract

Objectives: To assess the population health impact of high temperatures on workplace health and safety by estimating the burden of heat‐attributable occupational injury in Australia.

Study design, setting: Retrospective observational study; estimation of burden of occupational injury in Australia attributable to high temperatures during 2014–19, based on Safe Work Australia (work‐related traumatic injury fatalities and workers’ compensation databases) and Australian Institute of Health and Welfare data (Australian Burden of Disease Study and National Hospital Morbidity databases), and a meta‐analysis of climate zone‐specific risk data.

Main outcome measure: Burden of heat‐attributable occupational injuries as disability‐adjusted life years (DALYs), comprising the numbers of years of life lived with disability (YLDs) and years of life lost (YLLs), nationally, by Köppen–Geiger climate zone, and by state and territory.

Results: During 2014–19, an estimated 42 884 years of healthy life were lost to occupational injury, comprising 39 485 YLLs (92.1%) and 3399 YLDs (7.9%), at a rate of 0.80 DALYs per 1000 workers per year. A total of 967 occupational injury‐related DALYs were attributable to heat (2.3% of occupational injury‐related DALYs), comprising 890 YLLs (92%) and 77 YLDs (8%). By climate zone, the heat‐attributable proportion was largest in the tropical Am (12 DALYs; 3.5%) and Aw zones (34 DALYs; 3.5%); by state and territory, the proportion was largest in New South Wales and Queensland (each 2.9%), which also included the largest numbers of heat‐attributable occupational injury‐related DALYs (NSW: 379 DALYs, 39% of national total; Queensland: 308 DALYs; 32%).

Conclusion: An estimated 2.3% of the occupational injury burden in Australia is attributable to high ambient temperatures. To prevent this burden increasing with global warming, adaptive measures and industry‐based policies are needed to safeguard workplace health and safety, particularly in heat‐exposed industries, such as agriculture, transport, and construction.

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1 The University of Adelaide, Adelaide, SA
2 Australian Institute of Health and Welfare, Canberra, ACT
3 The University of Sydney, Sydney, NSW
4 Centre for Rural Health, the University of Sydney, Lismore, NSW
5 Monash Sustainable Development Institute, Monash University, Melbourne, VIC

Correspondence: peng.bi@adelaide.edu.au

Open access:

Open access publishing facilitated by The University of Adelaide, as part of the Wiley ‐ The University of Adelaide agreement via the Council of Australian University Librarians.

Acknowledgements:

This investigation was funded by the Australian Research Council with a Discovery Project grant (DP200102571) to Peng Bi. We gratefully acknowledge the Australian Institute of Health and Welfare for providing YLD estimates and supplying the disability weights and life tables produced by the Global Burden of Disease study, for providing methodological input, and for their assistance and guidance throughout the project. We acknowledge Safe Work Australia for providing deaths data for calculating YLLs and workers’ compensation claims data for calculating YLDs. We thank Syeda Hira Fatima and Matthew Borg (University of Adelaide) for their assistance with data analysis.

Competing interests:

No relevant disclosures.

1. Varghese BM, Barnett AG, Hansen AL, et al. The effects of ambient temperatures on the risk of work‐related injuries and illnesses: evidence from Adelaide, Australia 2003–2013. Environ Res 2018; 170: 101‐109.
2. Varghese BM, Barnett AG, Hansen AL, et al. Geographical variation in risk of work‐related injuries and illnesses associated with ambient temperatures: a multi‐city case‐crossover study in Australia, 2005–2016. Sci Total Environ 2019; 687: 898‐906.
3. Varghese BM, Barnett AG, Hansen AL, et al. Characterising the impact of heatwaves on work‐related injuries and illnesses in three Australian cities using a standard heatwave definition: Excess Heat Factor (EHF). J Expo Sci Environ Epidemiol 2019; 29: 821‐830.
4. Xiang J, Hansen A, Pisaniello D, Bi P. Extreme heat and occupational heat illnesses in South Australia, 2001–2010. Occup Environ Med 2015; 72: 580‐586.
5. Varghese B, Hansen A, Bi P, Pisaniello D. Are workers at risk of occupational injuries due to heat exposure? A comprehensive literature review. Saf Sci 2018; 110: 380‐392.
6. Romanello M, McGushin A, Di Napoli C, et al. The 2021 report of the Lancet Countdown on health and climate change: code red for a healthy future. Lancet 2021; 398: 1619‐1662.
7. Martínez‐Solanas È, López‐Ruiz M, Wellenius GA, et al. Evaluation of the impact of ambient temperatures on occupational injuries in Spain. Environ Health Perspect 2018; 126: 067002.
8. Concha‐Barrientos M, Nelson DI, Fingerhut M, et al. The global burden due to occupational injury. Am J Ind Med 2005; 48: 470‐481.
9. Australian Institute of Health and Welfare. Australian Burden of Disease Study: impact and causes of illness and death in Australia 2018 (cat. no. BOD 29). 24 Nov 2021. https://www.aihw.gov.au/reports/burden‐of‐disease/abds‐impact‐and‐causes‐of‐illness‐and‐death‐in‐aus/summary (viewed Jan 2023).
10. Beck HE, Zimmermann NE, McVicar TR, et al. Present and future Koppen–Geiger climate classification maps at 1‐km resolution. Sci Data 2018; 5: 180214.
11. Safe Work Australia. Work‐related traumatic injury fatalities time series. Updated 14 Nov 2022. https://www.safeworkaustralia.gov.au/doc/work‐related‐traumatic‐injury‐fatality‐time‐series (viewed Jan 2023).
12. Safe Work Australia. National dataset for compensation‐based statistics 3rd edition (revision 1). 20 Mar 2020. https://www.safeworkaustralia.gov.au/doc/national‐dataset‐compensation‐based‐statistics‐3rd‐edition‐revision‐1 (viewed Jan 2023).
13. Australian Institute of Health and Welfare. National Hospitals Data Collection. Updated 3 June 2022. https://www.aihw.gov.au/about‐our‐data/our‐data‐collections/national‐hospitals‐data‐collection (viewed Jan 2023).
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22. Dally M, Butler‐Dawson J, Sorensen CJ, et al. Wet bulb globe temperature and recorded occupational injury rates among sugarcane harvesters in southwest Guatemala. Int J Environ Res Public Health 2020; 17: 8195.
23. Marinaccio A, Scortichini M, Gariazzo C, et al; BEEP Collaborative Group. Nationwide epidemiological study for estimating the effect of extreme outdoor temperature on occupational injuries in Italy. Environ Int 2019; 133: 105176.
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26. Shaffer RM, Sellers SP, Baker MG, et al. Improving and expanding estimates of the global burden of disease due to environmental health risk factors. Environ Health Perspect 2019; 127: 105001.

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Perspectives

Planetary health: a new standard for medical education

Catherine GA Pendrey, Sonia Chanchlani, Laura J Beaton and Diana L Madden

Med J Aust 2023; 219 (11): . || doi: 10.5694/mja2.52158
Published online: 11 December 2023

ARTICLE
AUTHORS
REFERENCES

Topics

Environment and public health

Medical education

Health services administration

Global health

The Australian Medical Council (AMC) recently released updates to the National Framework for Prevocational (PGY1 and PGY2) Medical Training and the Standards for Assessment and Accreditation of Primary Medical Programs (medical school standards). Together, these cover all medical school programs in Australia and Aotearoa New Zealand and all accredited prevocational training programs in Australia.1,2 In a significant development, the standards recognise the health impacts of climate change, the need for environmentally sustainable health practice,3 and planetary health.4 This welcome and necessary development comes as climate and environmental health indicators deteriorate. All medical education institutions should now integrate planetary health into curricula to ensure the profession is equipped to respond to the unfolding planetary health crisis and realise environmentally sustainable health care.

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1 National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT
2 Climate and Environmental Medicine Specific Interests Group, Royal Australian College of General Practitioners, Melbourne, VIC
3 Melbourne Medical School, University of Melbourne, Melbourne, VIC
4 Doctors for the Environment Australia, Melbourne, VIC
5 University of Notre Dame Australia, Sydney, NSW
6 Australasian Faculty of Public Health Medicine, Royal Australasian College of Physicians, Sydney, NSW

Correspondence: catherine.pendrey@anu.edu.au

Open access:

Open access publishing facilitated by Australian National University, as part of the Wiley ‐ Australian National University agreement via the Council of Australian University Librarians.

Acknowledgements:

We thank all who have contributed to advancing planetary health education and practice in Australia, Aotearoa New Zealand, and globally.

Competing interests:

No relevant disclosures.

1. Australian Medical Council. New National Framework for Prevocational (PGY1 and PGY2) Medical Training (2024+). https://www.amc.org.au/accredited‐organisations/prevocational‐training/new‐national‐framework‐for‐prevocational‐pgy1‐and‐pgy2‐medical‐training‐2024/ (viewed Oct 2023).
2. Australian Medical Council. Standards for Assessment and Accreditation of Primary Medical Programs. Date of effect – 1 Jan 2024. https://www.amc.org.au/wp‐content/uploads/2023/08/AMC‐Medical_School_Standards‐FINAL.pdf (viewed Aug 2023).
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5. Beggs PJ, Zhang Y, McGushin A, et al. The 2022 report of the MJA–Lancet Countdown on health and climate change: Australia unprepared and paying the price. Med J Aust 2022; 217: 439‐458. https://www.mja.com.au/journal/2022/217/9/2022‐report‐mja‐lancet‐countdown‐health‐and‐climate‐change‐australia‐unprepared
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Disruption of gender‐affirming health care, and COVID‐19 illness, testing, and vaccination among trans Australians during the pandemic: a cross‐sectional survey

Sav Zwickl, Tomi Ruggles, Alex FQ Wong, Ariel Ginger, Lachlan M Angus, Kalen Eshin, Teddy Cook and Ada S Cheung

Med J Aust || doi: 10.5694/mja2.52169
Published online: 11 December 2023

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Infectious diseases

Social determinants of health

Abstract

Objectives: To assess rates of disruption of gender‐affirming health care, of coronavirus disease 2019 (COVID‐19) illness, testing, and vaccination, and of discrimination in health care among Australian trans people during the COVID‐19 pandemic.

Design, setting: Online cross‐sectional survey (1–31 May 2022); respondents were participants recruited by snowball sampling for TRANSform, an Australian longitudinal survey‐based trans health study, 1 May – 30 June 2020.

Participants: People aged 16 years or older, currently living in Australia, and with a gender different to their sex recorded at birth.

Main outcome measures: Proportions of respondents who reported disruptions to gender‐affirming health care, COVID‐19 illness, testing, and vaccination, and positive and negative experiences during health care.

Results: Of 875 people invited, 516 provided valid survey responses (59%). Their median age was 33 years (interquartile range, 26–45 years); 193 identified as women or trans women (37%), 185 as men or trans men (36%), and 138 as non‐binary (27%). Of 448 respondents receiving gender‐affirming hormone therapy, 230 (49%) reported disruptions to treatment during the pandemic; booked gender‐affirming surgery had been cancelled or postponed for 37 of 85 respondents (44%). Trans‐related discrimination during health care was reported by a larger proportion of participants than in a pre‐pandemic survey (56% v 26%). COVID‐19 was reported by 132 respondents (26%), of whom 49 reported health consequences three months or more after the acute illness (37%; estimated Australian rate: 5–10%). Three or more COVID‐19 vaccine doses were reported by 448 participants (87%; Australian adult rate: 70%).

Conclusions: High rates of COVID‐19 vaccination among the trans people we surveyed may reflect the effectiveness of LGBTIQA+ community‐controlled organisation vaccination programs and targeted health promotion. Training health care professionals in inclusive services for trans people could improve access to appropriate health care and reduce discrimination.

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1 The University of Melbourne, Melbourne, VIC
2 Austin Health, Melbourne, VIC
3 La Trobe University, Melbourne, VIC
4 ACON, Sydney, NSW

Correspondence: adac@unimelb.edu.au

Open access:

Open access publishing facilitated by The University of Melbourne, as part of the Wiley ‐ The University of Melbourne agreement via the Council of Australian University Librarians.

Data sharing statement

De‐identified participant data are available upon reasonable request to the corresponding author (adac@unimelb.edu.au), provided that the aim of the request is deemed to be of benefit to the trans and gender‐diverse community and has received Austin Health Human Research Ethics Committee approval (as an amendment).

Acknowledgements:

We thank the Melbourne Clinical and Translational Sciences (MCATS) research platform staff for the administrative and technical support that facilitated this investigation. Ada Cheung is supported by a National Health and Medical Research Council Investigator Grant (2008956).

Competing interests:

No relevant disclosures.

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