Letters

To the Editor: Nearly all industries profit from today's 25 million slaves and 150 million child labourers.1 The results of their work, including medical disposables, are sold worldwide. Unfortunately, there is not a comprehensive analysis identifying exactly where slaves are involved in the medical products supply chain. From the hazardous work forging surgical instruments in Pakistan to the manufacture of gloves in Malaysia,2 slavery permeates the manufacture and supply chains of medical products. Slaves are involved in the direct manufacture of medical products and in the generation of raw materials used to make medical devices, including cotton, rubber and metals.3 Some companies, have made a public effort to review their supply chains;4 however, many organisations are failing to monitor human rights abuses in their supply chains.5 As countries legislate Modern Day Slavery Acts, a few companies are moving to eliminate slavery. As an act of radical transparency in the long‐discussed issue of child labour in the cocoa industry, in 2017, Nestlé published the number of child labourers aged 5–17 years known to be working on cocoa farms that supply their cocoa.6 Nothing similar to Nestlé's effort has been done in the medical industry. However, notable efforts to regulate procurement have been demonstrated in the United Kingdom and Sweden.2 Few health professionals are responsible for the direct sourcing of medical products. Nonetheless, when speaking with managers, executives, and representatives of medical suppliers, we have the opportunity to share our concerns for the origins of the products we use. While a conversation with a medical representative on this topic may demonstrate scant knowledge of the manufacturing processes of the goods they are selling, that initial conversation is an important first step towards transparency, and we know that the influence of health professionals on industry is significant.7 Modern slaves are forced to work under threat of harm or by coercion or deception. Unable to refuse or leave, they earn little to no pay for extensive working hours in unsafe conditions, which may cause injury, sickness and, at times, death. Reports of harassment are common. In the medical industry, we must do all we can to address modern slavery because, above all, we should “first do no harm”.

Sharon Sitters

To the Editor: In August 2019, the Australian Institute of Health and Welfare (AIHW) released a report on chronic musculoskeletal conditions in Australia.1 In the report, the prevalence of gout is estimated at 0.8% (equating to 187 000 people), based on self‐reported survey data. This rate is much smaller than previously reported in Australia. Recent South Australian population‐based studies using “self‐reported doctor diagnosed gout” as the case definition reported the prevalence of gout as being between 5.2% and 6.8%.2 Thus, the rate of self‐reported gout detailed in the AIHW report is incongruous with published data and appears to be unusually low. The reported prevalence of gout in the AIHW document is based on the 2017–18 National Health Survey, in which participants were asked to self‐report doctor‐ or nurse‐diagnosed gout and whether the gout was current and expected to last for 6 months or more. Participants who did not identify as having current or long term gout did not have their condition recorded in the survey. Given that for most patients gout manifests as an intermittently flaring disease, with most flares lasting 7–10 days, respondents would likely not report their gout to be “current” or “likely to last 6 months” unless they have a clear understanding that gout is a chronic disease of monosodium urate crystal deposition. Many people with gout have not received this information from their health care providers and view the disease as present only when they are experiencing a flare.3 The chronic nature of the disease is reflected in the current definition of gout as “current or prior clinically evident disease”, as agreed by international gout experts.4 Gout is a systemic disease and an established independent risk factor for renal and cardiovascular disease. Like many chronic diseases, flares of gout and their long term consequences can be prevented with daily medication. However, both international and Australian evidence demonstrates that gout is inadequately treated, that persistence to urate‐lowering therapies is low, with suboptimal outcomes for patients.2 Under‐reporting and under‐recognition of gout and its burden on society is likely to contribute to undertreating and failure to manage it as a chronic disease — in contrast to other chronic conditions such as diabetes, in which the need for optimal disease management is well accepted. It is important that the burden of gout in Australia is understood and accurately measured to allow optimal use of limited health resources, reduce burden on society, and improve outcomes for people with this condition. Quality data are required but must be generated with appropriate definitions. We suggest that a validated case definition, such as “self‐reported gout” or “urate‐lowering therapies use”, be used in future Australian epidemiological studies.5

Helen I Keen · Philip C Robinson · Nicola Dalbeth · Catherine Hill

To the Editor: Amyotrophic lateral sclerosis (ALS) is a rapidly progressive and fatal neurodegenerative condition with no cure. Only two treatments with class I evidence exist — riluzole1 and edaravone2 — both with unclear mechanisms of action and modest survival benefits. In Australia, riluzole remains the only treatment approved by the Therapeutic Goods Administration. The Pharmaceutical Benefits Scheme limits initiation of riluzole to patients with at least 60% of predicted forced vital capacity, although facial weakness may make this an unreliable target. Initial and continuing treatment requires patients to be ambulant; or to have good upper limb function or to be able to swallow; and not to have respiratory failure. A recent retrospective study classified patients into different disease severity stages, ranging from 1 (one region involved) to 5 (death); patients with respiratory and nutritional failure were assigned to stage 4.3 The study identified that patients in stage 4 receiving 100 mg of riluzole daily did not progress to the next clinical stage (ie, death) as rapidly as those in milder stages. This suggests that the modest survival benefit experienced by patients taking riluzole comes about by extending the time spent at this stage. A quarter of patients present with bulbar or respiratory onset,4 making many ineligible for treatment, despite data suggesting they may benefit most.5 Mean survival in these forms of ALS is particularly short, meaning the modest survival benefit offered should be considered, as a majority of patients with advanced ALS do not wish to hasten death.6 A recent study of over 4000 trial participants confirmed benefit in both early and late stages,7 supporting use of riluzole throughout the disease. Few prospective studies on late‐stage treatments exist; patient choice in continuing treatment during advanced stages therefore remains paramount. Prospective studies are needed to establish whether the benefit of riluzole is weighted towards more advanced disease. However, recent studies, along with the recognition of the clinical spectrum of ALS, indicate that the current Pharmaceutical Benefits Scheme criteria are too stringent. As we move towards precision‐based medicine, different profiles of therapeutic response are likely. Regulators will be required to rapidly respond to emerging data to ensure the right patients can access the right medications.

Colin J Mahoney · Matthew C Kiernan

To the Editor: We applaud the astute perspective of Teede in relation to gender equity in medical leadership.1 Organisational culture that promotes male leadership styles is self‐perpetuating and this has implications for our specialty of endocrinology, which is rapidly becoming “feminised”. About 80% of physician advanced trainees in endocrinology are female and yet only 20% of heads of endocrinology departments in Australian training hospitals are women (Royal Australasian College of Physicians Advanced Training in Endocrinology Program, unpublished data). Waseem and colleagues2 documented significant under‐representation of women at higher academic levels in endocrinology societies internationally. Only 23% of full professors and 31% of board members were female. Women have fewer publications or research citations, but their skill sets are diverse and they bring value to executive boards through negotiation and problem solving skills. The historical biases around the expectations of women are perpetuated by male powerbrokers. Unconscious bias can be subtle. Duma and colleagues3 reported that when introducing female speakers at an international conference, men were more likely to use a woman's first name alone, but male speakers were introduced with full professorial title and surname. This undervalues the women who already tend to underplay their own skills. Part‐time employment may be supported in theory, but it is left up to the woman to find a solution. Women fear that part‐time work may challenge perceptions of competence. A healthy endocrinology training scheme must support our significant female workforce and serve the 70% of endocrinology outpatients who are women. We have wonderful male colleagues who are willing to support progress, but they may be deterred by the stigma attached to issues such as paternity leave. The current chair of the Royal Australasian College of Physicians Advanced Training Committee and the coordinator of the Advanced Training in Endocrinology Program are both women, so we do see a bright future ahead. This is an important issue for our patients, for women and for men.

Diana L Learoyd · Jane Holmes‐Walker

To the Editor: In their Perspective article, Mitchell and colleagues1 discuss the problems for patients resulting from overcautious attitudes in prescribing opioids within the constraints of the doctrine of double effect. In doing so, they also highlight how problems may be compounded by the inappropriate use of language in respect to voluntary assisted dying. Victoria has passed and is now implementing the Voluntary Assisted Dying Act 2017, not “assisted suicide” legislation. Like so much of the language we use, there are underlying, negative connotations to certain words. The use of the term “suicide” in the context of a person living with a terminal or serious and incurable condition that can only be relieved through death conflates two very different realities. One is the understandable or rational desire to avoid the trajectory of escalating suffering at the end of life, while the other is the tragedy of suicide resulting from social, financial or mental health conditions that culminate in feelings of abjection and of hopelessness towards the future. The focus of the authors of this article is both positive and welcome; assuring practitioners that they can adopt a proactive and patient‐centred approach towards pain relief. However, the use of language in this instance is unfortunate, as it has often been employed cynically to undermine the iterations of voluntary assisted dying Bills across Australia. Other common documented examples are referring to voluntary assisted dying as killing, murder, or state‐sanctioned murder — actions involving violence and malicious intent. Voluntary assisted dying is a managed and documented pathway embarked on by a person with decision making capacity to achieve a peaceful death on their own terms. Suicide, on the contrary, is a tragedy, usually undertaken alone as a violent and desperate act, including by people who have no legal recourse to voluntary assisted dying. It leaves a legacy of complicated grief for loved ones. Language is important. Without careful reflection, it can easily be used to subvert good intentions, including legal reforms. It can thereby thwart the will of the people — a perfect storm indeed.

Julia M Anaf

To the Editor: Uncontrolled before‐and‐after studies are highly prone to bias. Wabe and colleagues report on the impact of rapid influenza testing on outcomes for emergency department (ED) patients.1 They compared outcomes across four hospitals between the 2016 influenza season, when standard testing was used, and 2017, when rapid testing was used. Rapid testing was associated with shorter test turnaround times, more patients receiving results, and lower admission rates. Before‐and‐after studies use historical controls, in this case the prior influenza season, to evaluate the impact of interventions. This may be adequate for comparing simple indicators, such as test turnaround time, or for generating hypotheses. However, uncontrolled before‐and‐after studies are not useful for assessing more complex outcomes, such as admission rates, which are highly vulnerable to bias from other factors that may impact the observed results. For this reason, they are discouraged by some publishing groups.2 Frequent genetic drift in influenza virus strains causes variations in the burden and severity of illness each year, which influences ED presentations, testing and admission rates. The 2017 influenza season saw unprecedented numbers of influenza cases and ED presentations in NSW,3 which likely influenced admission practices. Teasing out the effect of rapid testing on admission rates is therefore not possible using an uncontrolled comparison between two disparate influenza seasons, in the manner of Wabe and colleagues. The steps taken to attempt to reduce seasonal effects cannot address this. It is also not possible to determine the net direction of biases in this study. Given the higher cost of rapid tests, it is important to have good estimates of their impact to inform economic evaluations. There are stronger methodologies that still allow timely evaluation using routinely collected data. At minimum, a comparison could be made to hospitals that did not implement rapid testing. When data from more seasons are available, an interrupted time series analysis may be appropriate.4 Interventions that mitigate the burden of seasonal influenza on health services are critical. Rapid testing is likely one such intervention, and therefore warrants careful evaluation with robust methodologies to inform its use.

Anthea L Katelaris · Ross M Andrews · Jeremy McAnulty

To the Editor: Currie and colleagues highlight the important topic of animal vaccines as occupational hazards and the need for improved clinician advice to manage patients safely.1 The article title describes “high pressure” injections, yet the oil emulsion vaccine of most concern, against ovine Johne's disease, is delivered via a standard needle injection. All accidental mineral oil injections are of concern (as are all high pressure injections). Appropriate identification and advice can be obtained by contacting a Poisons Information Centre (PIC). This was not discussed by Currie and colleagues, although it was recommended in a reference they cited.2 Unlike some vaccine manufacturers, the publicly funded PIC service provides 24‐hour emergency medical advice (131 126) for the public and health professionals. PICs access the Australian National Poisons Register, which allows rapid identification of the dozens of oil‐containing vaccines. Currently in Australia, oil adjuvant vaccines lack clear labelling to identify the presence of oil on the front packaging. Increased prominence would aid recognition, similar to initiatives for active ingredients within human therapeutic products. Indeed, review of the unscheduled status of most animal vaccines is required as they possess a risk assessment profile at odds with the Scheduling Policy Framework.3 Improved pharmacovigilance of veterinary products (and agrochemicals) is urgently required, particularly regarding the risks posed to human health. Unpublished analysis of data from Australian PIC annual reports identified about 2000 cases annually of human exposures to veterinary pharmaceuticals. We recently reported on human exposures to veterinary pharmaceuticals from New South Wales PIC calls from 2014 to 2016, with 30 exposures to Johne's disease vaccine alone.4 Collectively, PICs have over 20 times the number of reports to the designated authority for post‐market surveillance; the Australian Adverse Experience Reporting Program run by the Australian Pesticides and Veterinary Medicines Authority received 91 reports for human effects from registered veterinary medicines and agricultural chemical products combined in 2015.5 There is an opportunity for PICs to be engaged more efficiently in surveillance, which would allow the collection of additional information through follow‐up calls to understand risk factors, evaluate outcomes and recommend interventions to prevent future injuries. This would facilitate improvements in management of human exposures to veterinary pharmaceuticals to protect occupational health.

Jared A Brown · Nicholas A Buckley · Rose Cairns · Claire E Wylie

To the Editor: We thoroughly enjoyed the insightful review on erectile dysfunction by McMahon.1 We offer some observations, as most of the abnormalities described in erectile dysfunction are also associated with obstructive sleep apnoea (OSA). Fortunately, OSA can be reliably diagnosed in 80% of cases by bilateral, simultaneous, lateral, passive, anterosuperior, paramarginal distraction of a patient's upper eyelids.2 Finding lax (floppy) lids clearly has a positive association with OSA. Clinical examination of patients with lax eyelids — and in their extreme manifestation, floppy eyelid syndrome — can elucidate a patient's preferred sleeping laterality. Moreover, the presence of OSA can be imputed if the lid laxity is moderate to severe.2 We were concerned that there was no mention of the pathogenetic association of OSA with erectile dysfunction; it may be prudent to exclude OSA in patients diagnosed with erectile dysfunction. As management of floppy eyelid syndrome includes weight loss, it was gratifying to see McMahon emphasising lifestyle modification to reduce the impact of vascular risk factors. Similarly, upper eyelid laxity can also be improved with weight loss.3 This also benefits the OSA‐related complications of hypertension, diabetes, myocardial infarction, stroke and depression, and the ophthalmological complications of floppy eyelid syndrome. It was pleasing to note that McMahon referred to non‐arteritic ischaemic optic neuropathy. However, this condition occurs not only in the context of utilisation of phosphodiesterase type 5 inhibitors but also as a consequence of OSA.4 We suggest that clinicians carry out lid distraction to screen for OSA and assist in the diagnosis and management of erectile dysfunction.

Kriti Agnihotri · Eugene Ting · Ian C Francis

To the Editor: Over the past decades, the incidence of type 2 diabetes, rarely diagnosed in children and adolescents before the 1990s,1 has been increasing in young people in several populations, including Australia.2,3,4 Early onset type 2 diabetes appears to have a more severe phenotype compared with adult onset type 2 diabetes, and has a high prevalence of complications already present at the time of diagnosis despite the patients’ young age and short duration of the disease.5 We aimed to describe the characteristics of Western Australian children aged less than 10 years diagnosed with type 2 diabetes between June 2000 and June 2017. Demographic and clinical data for children diagnosed with type 2 diabetes during the study period were extracted from the population‐based WA Children's Diabetes Database and via manual review of hospital clinical files. Of the 193 children aged less than 16 years diagnosed with type 2 diabetes in WA during the study period, 12 children were diagnosed at less than 10 years of age, with the youngest aged 6 years and 11 months. These 12 patients had one or both parents diagnosed with type 2 diabetes, 11 children were Aboriginal Australians, one was Māori, 11 were obese (mean body mass index z‐score, 2.38; standard deviation [SD], 0.64); nine were female, and seven had one or more comorbidities. Of the 11 children examined, ten had acanthosis nigricans present on their skin. Three children presented with polyuria and polydipsia, six were unwell with other illnesses and three were asymptomatic. Type 1 diabetes antibodies were negative in seven of eight of the children tested, and the mean glycated haemoglobin level at diagnosis was 75 mmol/mol (mean, 9.0%; SD, 2.4%). Nine patients had one or more diabetes complications present at the time of diagnosis; seven had dyslipidaemia, two had an elevated albumin creatinine ratio, and three had hypertension. Our study describes the common clinical features of early onset type 2 diabetes in young children in WA, such as history of parental type 2 diabetes, Aboriginal heritage, obesity, and female sex, and provides strong evidence for the need to screen children with these risk factors for type 2 diabetes, irrespective of their age. Moreover, the high prevalence of diabetes complications present strongly supports the need for complications screening at the time of diagnosis.

Jacqueline A Curran · Aveni Haynes · Elizabeth A Davis

To the Editor: In July 2019, sarcopenia — a progressive and generalised skeletal muscle condition involving loss of skeletal muscle mass and function1 — was awarded a code in the International Classification of Diseases, tenth revision, Australian modification (ICD‐10‐AM). This recognition has arrived 30 years after Irwin Rosenberg first described the condition in 1989.2 Sarcopenia is independently associated with poor quality of life, falls, fractures, institutionalisation and mortality.1 About 13–19% of community‐dwelling older adults may have this condition, and prevalence is highest among those living in residential care.1 All individuals experience declines in muscle mass and function during ageing, but only those who meet the criteria described in the Box are considered to have sarcopenia. The definition currently promoted by the Australian and New Zealand Society for Sarcopenia and Frailty Research is the initial European Working Group on Sarcopenia in Older People definition,3 which was adopted after a Delphi consensus.5 Measures of muscle strength and physical performance such as grip strength, chair stands and gait speed are cost‐effective and easy to perform in clinical practice. Obtaining measures of muscle and lean mass may be challenging outside of the research setting. Therefore, in individuals with low muscle strength or physical performance, in the absence of other potential causes (eg, osteoarthritis), sarcopenia should be suspected and safe and effective interventions can be offered. Patients with, or at risk of, sarcopenia should be recommended exercise therapy, in particular, progressive resistance training.1 This type of training prescribed by treating clinicians can be implemented by allied health professionals, including exercise physiologists and physiotherapists. Protein supplementation can prevent loss of muscle, but this is most beneficial when combined with progressive resistance training.1 A number of randomised controlled trials are underway examining different therapeutics for the treatment of sarcopenia.1 With the advent of the ICD‐10‐AM code, primary care clinicians, allied health staff, and members of the public will begin observing sarcopenia diagnoses on medical correspondence. Hospital funding models may adjust in line with the ICD‐10‐AM code and in recognition of the increased complexity and risk of complications that comes with caring for patients with sarcopenia. An understanding of this condition, its implications and treatment is key in providing evidence‐based care to patients living with sarcopenia. Box – Diagnostic tools and measurements to diagnose sarcopenia* using the initial European Working Group on Sarcopenia in Older People (EWGSOP) definition†3 Component Thresholds and equipment Low muscle strength Hand grip strength using dynamometer: Men: < 30 kg Women: < 20 kg Low physical performance Men and women over 4 m course: Gait speed: ≤ 0.8 m/s Low lean mass ALM using whole‐body DXA (adjusted for height, m2): Men: < 7.26 kg/m2 Women: < 5.50 kg/m2 ALM = appendicular lean mass; DXA = dual x‐ray absorptiometry. * Diagnosis of sarcopenia is based on low lean mass and low physical performance or muscle strength. † The EWGSOP have developed a revised definition for sarcopenia (known as EWGSOP2);4 however, this has not yet been recommended for use in Australia.

Jesse Zanker · David Scott · Sharon L Brennan‐Olsen · Gustavo Duque

To the Editor: As reported by Rowe and colleagues1 in their retrospective analysis of maternal immunisation, uptake of influenza and acellular pertussis vaccines among pregnant women remains unacceptably low. One contributing factor may be inconsistent messaging. Historically, vaccine manufacturers have included precautions about the lack of data on use in pregnancy in their product information sheets. Such precautions have been shown to lead to vaccination hesitancy and refusal among pregnant women.2,3 In contrast, the current edition of the Australian Immunisation Handbook states: “Pregnant women are routinely recommended to receive influenza vaccine … and pertussis‐containing vaccine”.4 In 2018, the Therapeutic Goods Administration asked its Advisory Committee on Vaccines to provide independent expert advice on the available safety data on influenza vaccination in pregnancy with regards to the pregnancy category of influenza vaccines. The Advisory Committee on Vaccines advised that “adoption of Australian Pregnancy Category A should be considered by sponsors for certain inactivated influenza vaccines”.5 Pregnancy Category A signals to doctors and the public that the vaccine has been used by large numbers of expectant mothers with no evidence of harm to their babies. This is in line with the Australian Immunisation Handbook: “Clinical trial data and observational studies show no increased risk of congenital defects or adverse effects in the fetuses of women who received influenza vaccine during pregnancy”.4 Following the publication of the Advisory Committee on Vaccines statement, two of the four adult influenza vaccines and one of the two acellular pertussis vaccines used to vaccinate pregnant women in Australia have changed their pregnancy category to Category A. These changes show that the Australian regulator is receptive to feedback from the medical community on how to improve immunisation rates. Hopefully, the reclassification of the pregnancy category of these vaccines will translate into increased maternal uptake and better outcomes for Australian mothers and babies.

Heidi Shukralla · Michael Coory

Christmas is known for festive decorations

Paul Heyworth · Ryan Shulman

To the Editor: The editorial by Murnion and Conigrave1 and the article by Crossin and colleagues2 on the dangers of misuse of pregabalin are a timely warning to all prescribers. The black market utility (based on testimonies) and frequent misuse of pregabalin is well known both academically and to prescribers in prison environments.3,4 Harm relating to gabapentinoid use is noted to be increasing globally. A 2017 case–control study showed a dramatic increase in relative risk of death with opioid and gabapentinoid versus opioid alone.5 People leaving prison are at a higher risk of opioid overdose death, partly because of loss of tolerance.6,7 This will likely be compounded by inappropriate gabapentinoid prescribing. In New South Wales prisons, the Justice Health and Forensic Mental Health Network sees many patients who present seeking pregabalin and other prescription drugs in our health clinics. Patients often enter custody using high doses of medications prescribed in the community, including gabapentinoids, benzodiazepines and opiates. The Network applies a multidisciplinary team approach between primary care, pharmacy, and drug, alcohol and mental health services for these complex patients. Furthermore, clinicians undertake regular medication reviews of patients; medications that are not indicated are deprescribed to reduce potential harm to patients.8,9 The Network has developed management guidelines around gabapentinoid use, including regular review of prescriptions by general practitioners and the clinical director. Off‐label use is discouraged. Pregabalin is always a supervised medication, and dose limits and deprescribing programs are in place to limit availability if not indicated. Alternate medications for the management of diagnosed neuropathic pain are effective and may pose less risk in prison environments.8,9 Gabapentinoid drugs are not used as an alternative to opiate pain medications in NSW prisons. Patients are assessed and given appropriate medications according to the quality and safe use of medicines approach, and medication charts are regularly audited to ensure safe prescription of medications. There has been an overall reduction in actual gabapentinoid prescribing in NSW prisons in recent years. We encourage all Australian prescribers to ensure care around prescribing of gabapentinoid and other medications, especially for complex patients with drug and alcohol misuse and polypharmacy issues.

Gary Nicholls · Peter Samios · Stephen Hampton