Perspectives

Governments and international agencies need to embrace quality regulation of pharmaceuticals as well as contingency plans For the first time in six decades, intravenous penicillin will not be available on hospital shelves in Australia. CSL Limited, who distributes benzylpenicillin in Australia, has been informed by their supplier that due to international floods and disasters, there is a critical global shortage. CSL gave Australian hospitals less than 2 weeks’ notice, and have warned that resumption of local supply is not expected until December 2011. Shortages of critical life-saving medicines are an increasing threat to public health.1 Although there have been no official medication shortages in Australia in 2011, the true problem is unrecognised here and is escalating internationally. In the United States, there have been 198 drug shortages over the past 3 months,2 more than double that for the entire year of 2007.3 The only organisation in Australia attempting to alert prescribers to impending shortages, the Society of Hospital Pharmacists of Australia, has listed only seven medications to date, while the Therapeutic Goods Administration, which only notifies prescribers once drugs are beyond critically short supply, has listed none. The reasons behind these shortages are complex and include increased demand, manufacturing delays, recalls, shortages of ingredients, and the realities of business in a competitive international market.1,4 For many medicines, there are only a few sites worldwide, mainly in India and China, that manufacture pharmaceutically active ingredients. Some of these sites are the sole source of multiple active ingredients.5,6 With the opacity of international manufacturing processes, it is very challenging even for governing agencies to understand where medicines are sourced, and subsequently to anticipate geopolitical supply chain vulnerabilities or breaches in quality and safety.5,6 Australia, which produces less than 5% of the pharmaceuticals it consumes,7 is particularly vulnerable. Shortages in essential medicines occurring at a local hospital level are most commonly a result of international trade and manufacturing issues, as attested by recent shortages in heparin,8 propofol9 and injectable antibiotics.10 However, with increasing instability in climate, a natural disaster locally or distantly could significantly interrupt manufacture and supply chains, and could lead to unexpected disaster-associated mortality globally. To better understand our local vulnerabilities, we conducted a hypothesis-generating study by analysing consumption and stock reserve of essential medications in our hospital system. The Hunter New England Local Health Network in New South Wales provides hospital care to a population of 413 000 people in a defined geographical area, broadly representative of the Australian demographic.11 We hypothesised that the hospital pharmaceutical reserve was less than 30 days’ supply for a significant proportion of commonly used essential medicines. Further details of our study method are shown in Box 1. Of the 378 essential medicines on our modified list (Box 1), 3% had less than 7 days’ reserve, 24% had less than 30 days’ reserve, and 26% had more than 3 months’ supply. There were 76 medicines that were high volume and these generally had the least stock reserve, with 51% having less than 30 days’ supply. Medicines used in more acute settings, for instance anti-infectives, analgesics, intravenous fluids and anticoagulants, had relatively small reserve capacity, but all had at least 7 days’ supply (Box 2). There was 34 days’ supply of benzylpenicillin, with 27 defined daily doses prescribed each day in the hospital network. Medicines used for chronic conditions generally had greater reserve capacity, with most having more than 1 month’s supply. Only one of the 25 antihypertensive agents and one of four statins had less than 30 days’ supply. Two of the five antianginal agents, three of the five antidiabetic agents and four of the six diuretic agents had more than 3 months’ supply. Low-volume medicines, representing 138 agents, generally had large reserve capacity, with 62% having more than 3 months’ supply. HIV medicines and cytotoxic drugs had low reserve capacity (Box 2), a reflection of pharmacy policy designed to reduce cost and expiry of expensive medicines with short shelf lives. For local disasters, most hospitals would be able to act as community reserves of essential medicines, particularly those used in the treatment of chronic disease, for which most hospitals will have substantial reserve supplies. It has previously been demonstrated that interruption to the supply of medicines to those with chronic health problems contributes significantly to disaster-associated mortality.12 It is imperative that hospital pharmacies are designed to be protected from flooding and damage from natural disasters, that local suppliers are integrally involved in disaster planning, and that there is contingency for hospitals to act as large-scale community dispensaries if required. This is particularly the case for hospitals in northern Australia, where the risks of flooding are greater and where the supply chain is more geographically vulnerable. Our study brings into question the utility of the National Medical Stockpile. There are more cost-effective ways of sourcing non-surge-related essential medicines; for instance, hospital and community requirements for antihypertensive medicines will not surge in the event of a disaster, but oseltamivir would surge in the event of an influenza pandemic, as would antidotes in the event of mass poisoning. With appropriate national or state linking of hospital pharmacy databases of essential non-surge drugs, similar to the NSW Register of Lifesaving Drugs, medicines could be mobilised rapidly to where they are needed and the stockpile could be significantly downsized. There is no official mechanism for identifying drug shortages in Australia. Setting up a monitoring system — for example, via a sentinel hospital pharmaceutical supply — could help identify impending drug shortages locally and allow earlier rationalisation to mitigate such events. Legislation could be enacted to compel manufacturers and wholesalers to report compromise of manufacture or supply. Although many developed countries have registries of efficacious “essential” drugs, there have been no previous attempts to define nationally relevant essential medicines in terms of disaster management and supply chain vulnerability. Our study does not attempt to develop such a list but defines usage of classes of medicines. A national list could be simplified to include a single medicine from each subclass with strategically valuable attributes, for instance, medicines that are manufactured locally. A national list of essential medicines would enable local regulatory bodies such as the Therapeutic Goods Administration to focus on supply chain issues of critical drugs. International efforts need to focus on sustainable supply of essential medicines and equipment. The WHO needs to consider environmental threats to key international manufacturing plants of essential medicines, and could incorporate such requirements into good manufacturing practice guidelines. From a longer-term perspective, pharmaceutical supply, similar to food security, is likely to become a more prominent global problem. Governments and international agencies such as the WHO have an obligation to embrace not just quality regulation of pharmaceuticals but also contingency plans for unforeseen global events; events that are increasingly severe as climactic variables become more unpredictable and extreme. From an Australian perspective, this means adopting policy that encourages local manufacturing industries to have some capacity to fill the gaps in essential pharmaceuticals and medical equipment if they ever appear, and it requires national procurement decisions to be based not just on cost but also on sustainability. 1 Consumption and stock reserves of essential medicines in the Hunter New England Local Health Network: study method A local list of essential medicines was derived from the 2010 World Health Organization (WHO) model list of essential medicines (http:/www.who.int/medicines/publications/essentialmedicines), modified by a clinical pharmacologist (A J), a general physician (S Q) and four hospital pharmacists (L H, J K, R P, R J), and grouped into 26 drug classes. Three classes were excluded (representing 3% of 378 medicines) because they were not managed by the pharmacy. We excluded 110 WHO-listed medicines because they were not stocked. We included 108 medicines not listed by the WHO because they were replacements for the WHO-listed medicines (eg, alteplase replaced streptokinase) or were the pharmacological and clinical equivalent of a WHO-listed drug. Stock of a medicine was measured on 2 June 2011 using WHO defined daily doses (DDD) or a unit corresponding to clinical use (eg, a single-use vial of ketamine). We calculated the annual and daily medicine consumption over the previous year using pharmacy databases and iPharmacy software (iSOFT, Banbury, Oxf, UK). We calculated stock reserve on the basis of daily medicine consumption and stock amount. High-volume consumption was defined as > 0.05 DDD/hospital bed/day. Low-volume consumption was defined as < 0.005 DDD/hospital bed/day. 2 Stock reserves of essential medicines, by subclass Subclasses with more than 30% of medicines having < 30 days’ supply No. of medicines in subclass Proportion of subclass < 30 days’ supply Medicines used for anxiety disorders 1 100% Opioid analgesics 5 80% Medicines used in substance dependence 3 67% General anaesthetics 4 50% Local anaesthetics 6 50% Antacids and other antiulcer medicines 8 50% Oxytocics 4 50% Vitamins and minerals 6 50% HIV medications 18 45% Antibacterials (systemic) 27 44% Cytotoxic medicines 20 40% Anti-infective medicines* 77 36% Parenteral fluids* 11 36% Gastrointestinal medicines* 26 31% Medicines affecting coagulation 6 30% Antifungals (systemic) 10 30% * Entire class has less than 30 days’ supply.

Simon Quilty MB BS, MPhilPH, BEng · Lisa M Harris BSc, BPharm · Jacqueline Kewley BPharm, GradCertPH · Alison Jones FRACP, FRCP · Robert Pearce BPharm, GradDipBA · Rosemary James BPharm · Forbes McGain FANZCA, FCICM

Health reporter Ray Moynihan explores disturbing new data about the ever-popular pills After analysing antidepressant use among older people in Britain for more than a decade, a team of researchers has come up with some alarming new findings. Released recently, their study barely raised a murmur in Australia, but its implications are potentially enormous.1 If the new data are to be believed, for older people, the most commonly prescribed drugs for depression may be associated with an increased risk of serious health problems and death compared with less common antidepressants or none at all. Conducted as part of the Health Technology Assessment program, this British prospective cohort study investigated the risks associated with antidepressants being used by people aged 65 years or older during the decade or so to 2008. Its database included more than 60 000 people from 570 general practices across the United Kingdom who had been newly diagnosed with depression. Results published in the BMJ show that more than half of the antidepressant prescriptions issued to this group were for drugs from the selective serotonin reuptake inhibitor (SSRI) class, almost a third were for older tricyclics, and just over one in 10 were for other antidepressants.1 Eleven per cent of the people in the study did not take any drugs for depression. For those who did take antidepressants, the median duration of use was 1 year. Interestingly, more than two-thirds of the older people had the severity of their depression classified as mild, a quarter as moderate, and just under 5% as severe — and these proportions were similar for those who were and those who were not prescribed antidepressants. The researchers then compared the adverse events experienced by people during the time they were taking the drugs with those experienced by people during periods when they weren’t taking the drugs, and it was these comparisons that produced the unexpected and disturbing associations. The absolute risk of death from all causes over 1 year was 10.6% for patients taking SSRIs, 8.1% for those taking tricyclics, 11.4% for those taking other antidepressants, and 7.0% for people not taking any antidepressants. Moreover, those taking antidepressants suffered a significantly greater number of serious adverse events: All classes of antidepressant drug were associated with significantly increased risks of all cause mortality, attempted suicide/self harm, falls, fractures, and upper gastrointestinal bleeding compared with when these drugs were not being used.1 Despite being heavily promoted as better than the older medicines, the study found that, compared with tricyclic antidepressants, the newer SSRI class “may be associated with an increased risk of ... all cause mortality, stroke/transient ischaemic attack, falls, fracture, epilepsy/seizures, and hyponatraemia”. The obvious limitation here is that the study was observational, rather than a randomised controlled trial. However, as is made clear in their full 200-page report for the Health Technology Assessment program,2 the researchers went to great lengths to identify a wide range of potentially confounding variables, including age, sex, comorbidities and the severity of depression. Yet after adjusting the results for the confounding variables, key associations were largely unaffected. For example, after adjusting for confounders, taking SSRIs was still associated with a roughly 50% higher chance of death in relative terms, as well as an increased risk of serious adverse events including attempted suicide, falls and fractures, compared with those diagnosed with depression who were not taking antidepressants. In discussing the findings of their observational study, the authors highlight the difficulty of untangling the effect of the drugs from the effect of the underlying condition, particularly as they were unable to adjust for the way the severity of a patient’s depression might have changed during the decade of the study. Putting their results in the context of other data, the researchers conclude that their findings of higher rates of attempted suicide for all classes of antidepressants “suggest an effect of depression itself rather than a direct causal effect” of the drugs.2 By contrast, they conclude their findings of higher rates of falls, fractures and hyponatraemia associated with some antidepressants are generally in line with existing data. Importantly, the study’s limitation is also its strength. Looking at the serious health problems experienced by many thousands of people taking antidepressants over a long period, these real-world results are potentially more relevant than small, short-term, company-funded trials with extensive exclusion criteria, which may lead to overstating benefits and playing down harms of drugs. Whatever your view of the benefits of these heavily marketed medicines, this latest study provides important new information about their associated downsides.

Ray Moynihan BA

Clinical guidelines are being increasingly produced to improve quality of care, but are vulnerable to bias. Only 15% of guidelines on the National Health and Medical Research Council portal from the most prolific developers have published conflict of interest statements, and fewer detail the processes used to manage conflicts. Comprehensive disclosure of conflicts is needed to safeguard the integrity of clinical guidelines and the medical profession. Peak bodies and clinicians should seek to promote an improvement to current poor practice.

Michael J Williams* BA(Hons), LLB(Hons) · Dev A S Kevat* MB BS, LLB(Hons), MPH(Oxon) · Bebe Loff LLB, MA(Lond), PhD

A failure of practice, or a failure of evidence? Drug treatment of rheumatoid arthritis (RA) has evolved significantly in recent decades, owing to increasing evidence supporting early intervention with disease-modifying therapies and the advent of novel biological therapies that specifically target the immunological and cellular mediators of disease. In the past 10 years, there have been over 60 systematic reviews and meta-analyses of pharmacotherapy in RA, reflecting the growth in development of new drugs and the shifting landscape of treatment regimens. Although these reviews vary in scope and focus, there is considerable overlap of the studies that are included. The findings of these reviews are mostly consistent and support early use of disease-modifying antirheumatic drugs (DMARDs) titrated appropriately for control of the disease process; the safety and efficacy of methotrexate as a first-line agent; and the clinical utility of corticosteroids in managing disease flares.1 Over 30 of these reviews have focused on the use of biological agents, such as infliximab and etanercept, in the management of RA refractory to traditional (synthetic) DMARDs. The published literature generally supports the short-term efficacy and safety of biological agents as adjuncts or alternatives to traditional DMARDs.2 During this same period there have been more than 10 major clinical practice guidelines produced for the management of RA. We analysed 10 of these guidelines and found that seven were government funded (although some contributors declared the receipt of support from industry), one had industry sponsorship and two were produced by private companies. Eight of these guidelines explicitly outlined their search strategies, their criteria for including studies and their methods for assessing studies according to levels of evidence. The guidelines’ assessments of the evidence base for pharmacotherapy in RA are highly concordant. This is not only true for recommended strategies, such as the early use of DMARDs, but also for identification of some areas of continuing uncertainty, including the routine use of corticosteroids, the role of intra-articular steroid injections, and the use of complementary and alternative medicines.3 The subjection of the literature to such careful and repeated analysis and the consistent findings of the systematic reviews and clinical practice guidelines might appear to provide reassurance about the guidance available for practitioners in the clinical management of RA. Yet, despite the clarity of the assessment of the evidence base, closer inspection reveals significant limitations of the evidence that is available to those who produce and implement guidelines. While early use of methotrexate has a solid evidence base, data remain incomplete on its efficacy and its safety at varying doses, particularly among certain ethnic groups and during pregnancy and breastfeeding.4 And despite the fact that numerous trials of individual biological agents have demonstrated their short-term efficacy and safety, it is difficult to compare them as there have been few head-to-head trials of these drugs.5 This is problematic clinically, because different agents may confer different benefits and harms in different patients; and economically, because it compromises comparative cost-effectiveness analysis. Data are also lacking on the long-term safety and efficacy of biological agents, and the relative and absolute benefits of these agents when they are used at different time points in the clinical course of patients with RA, although some long-term safety data are beginning to emerge.6 Finally, there is considerable uncertainty about the various ways in which the synthetic DMARDs and the newer biological agents should be combined.7 Against the background of these limitations and the consistent support for early use of DMARDs, what are rheumatologists’ prescribing habits? A French study found little conformity between rheumatologists’ prescribing practices and clinical practice guidelines — 34% of patients with early RA did not receive any DMARD.8 A Canadian study also found an inappropriately low rate of prescribing; 84% of patients who regularly saw a rheumatologist were prescribed a DMARD, as were 73% of patients who consulted a rheumatologist intermittently.9 One common explanation for these findings is that clinicians are slow to translate research into practice, even where the evidence appears to be clear, as is the case for early use of DMARDs. An alternative explanation is that clinicians are cognisant of deficiencies in the evidence base, sceptical of the content of guidelines, sensitive to “non-clinical” concerns such as the cost of medicines, and wary of generalising data from systematic reviews and meta-analyses to the care of individual patients. It might not be that clinicians are resistant to change — apparent “failures” in translation might equally be attributable to problems in the evidence base (and the potentially confusing proliferation of clinical practice guidelines by diverse stakeholders and for various target audiences10) as they are to habit, lack of motivation, and external barriers such as lack of time, resources and organisational support.11 This has a number of practical implications. First, concordance among systematic reviews and agreement among clinical practice guidelines should not obscure important deficiencies in the evidence regarding RA. But neither is it enough for commentators and expert bodies to simply identify gaps in the literature. Health care and research communities both have a responsibility to question the evidence upon which guidelines are based. The absence of head-to-head studies and long-term data from postmarketing surveillance studies should raise questions about possible biases arising from industry sponsorship of clinical trials and from trials designed according to the requirements of regulatory agencies.12 The relative absence of data on non-pharmacological therapies in RA should also raise questions about the dataset and the emphasis in clinical research on pharmacotherapies. While Australia’s National Medicines Policy provides a framework for improving prescribing practices through advocating the quality use of medicines,13 this relies upon a comprehensive and clinically relevant evidence base, and all stakeholders have a responsibility to ensure that the right research questions are asked and the right methods are used to answer them.

Shafqat Inam BSc(Med)Hons, MB BS · Wendy L Lipworth MB BS, MSc, PhD · Ian H Kerridge B(Med), FRACP, FRCPA · Richard O Day MB BS, MD, FRACP

Health promotion expert Garry Egger argues that obesity is a sentinel of broader environmental causes of chronic disease Any important disease whose causality is murky, and for which treatment is ineffectual, tends to be awash in significance. Susan Sontag, Illness as metaphor1 Evidence in science requires time, but when that evidence arrives, it may suggest that we need to think about things differently. In the case of research into the relationship of obesity to chronic disease, the accumulating weight of evidence has meant a rethink of what obesity means, and what we are trying to achieve in “treating” obesity. After three decades of rapid increases in mean national bodyweight, we now seem to accept that we have a problem. Around one in two Australians are overweight (body mass index [BMI] > 25 kg/m2), and more than one in three are obese (BMI > 30 kg/m2).2 However, now that the message has hit home, the evidence relating obesity to chronic disease has started to shift. Some question whether obesity really is the issue. Should we be focusing instead on those factors (such as lifestyle, environment and social factors) that may (or may not) cause obesity? Why the change of heart? There is little doubt that obesity is linked with the dysmetabolism associated with much chronic disease, and particularly type 2 diabetes. But there are also more distal drivers, which may or may not require obesity in the causal pathway for chronic disease to occur, and these may not be considered if the focus is purely on obesity. This has become clear with the concept of “metaflammation”3 — a form of low-grade, persistent systemic and chronic inflammation, which is associated with much, and perhaps most, chronic disease. While the classical form of inflammation has a healing role in acute disease, metaflammation, because of its persistence, may have a causal role in aggravating and perpetuating chronic disease. Linked not just to obesity, it is also associated with a range of “inducers”, some of which directly cause obesity (overnutrition, inactivity, stress), but also many that are not direct causes.4 These include environmental factors like pollution and passive smoking, a newly identified group of endocrine-disrupting chemicals, and social and occupational factors such as inequality, perceived injustice and even shift work. Together, these make up a group of inducers of chronic disease that could be called “anthropogens” — human-made environments, their by-products, and associated lifestyles. Some of these may be detrimental to human health; all have arisen since the industrial revolution and seem to be foreign to our ancient physiology. These anthropogens may be considered to be the “germs” behind many chronic diseases. A focus just on the proximal causes of obesity and associated individual behaviours could have the adverse impact of blaming individuals for the environment that surrounds them. It deflects criticism from more distal social and environmental causes, where the recognition of an anthropogen-based causality would get to the heart of chronic disease causation. Given this, what would be the point of targeting the “fit fat” — the 35% of obese individuals who have no obvious health risk (apart from mechanical and possibly psychological issues) — and ignoring the approximately 25% of lean people who fit the “lean unhealthy” phenotype and have all the risks expected of the obese?5 The current focus is on visceral fat, which gets close to the issue, but we need to think about what is causing visceral adiposity in the first place. All this points to obesity as an intermediary as much as an offender in chronic disease — it is a sentinel of problems in the broader environment. This is not to suggest that weight loss is not a justifiable goal; of course it is. But to do the job properly, it should be accompanied by broader initiatives aimed at targeting the anthropogens that are using obesity as their cover.

Garry Egger MPH, PhD

Public health expert Ken Harvey believes that they should In theory, allowing people to make their own choices about purchasing products, unfettered by a “nanny state”, sounds fine. However, this assumes that consumers can make informed, rational choices about the cost, risks and benefits of a given product, and that their decisions have no impact on others. In practice, humans are far from rational. We have problems controlling consumption and behaviour, such as how much we eat, drink, or smoke, and how much we spend on poker machines. Advertisers aim to maximise the apparent benefits of products and minimise their risks, and to convince us that expensive, branded products are worth more than no-frills ones. They argue, with the powerful voice of large corporations, that interventions to reduce our consumption of harmful products are an affront to our autonomy. Furthermore, many of our individual decisions do affect others: smoking in enclosed shared spaces and drink-driving cause harm, injury and death to others; and gambling addiction destroys families. Such individual actions have societal costs — premature death, hospitalisation and the need for remedial services — problems often most prevalent in poorer, more disadvantaged populations; some industries specifically target these groups.1 Clearly, the problem of unhealthy consumption and the associated health consequences are societal problems that require a societal approach. Public health policy, appropriately based on relevant evidence and research, is key to a societal approach. Public health is defined as “what we, as a society, do collectively to assure the conditions in which people can be healthy”.2 To know if governments need to restrict people’s choices for the sake of public health, we need evidence about the causes of ill-health, and the effectiveness of proposed interventions. For example, the link between smoking, lung cancer and other diseases is well established, but establishing how much obesity is “caused by” advertising of junk food is harder to quantify. We also need to know if interventions work, and their potential for both benefit and harm in different segments of the population. However, where evidence supports it, policy should be formulated to appropriately limit choices that impact on health. The range of options available to government and policymakers can be thought of as a ladder of interventions, with the rungs representing the degree of freedom individuals should have to make individual choices about their health.3 In considering which “rung” is appropriate for a particular public health goal, the benefits to individuals and to society must be weighed against the erosion of individual freedom. Economic costs and benefits need to be considered alongside health and societal benefits. At the top (most restrictive end) of the intervention ladder, legislation eliminates choice (eg, compulsory seatbelt legislation, banning smoking in public places and random breath testing). One rung down from this, the range of options available are restricted (eg, removing unhealthy ingredients from foods, or unhealthy foods from shops or restaurants). On the next two rungs down, a full range of choices may remain available, but (i) fiscal or other disincentives can be used to influence behaviour (eg, taxes on cigarettes, alcohol and junk food; precommitment limits on gaming machines), and (ii) people can be encouraged to make beneficial choices (eg, by subsidising the cost of nicotine patches through the Pharmaceutical Benefits Scheme). A variant of this is leaving a full range of options available, but changing a default policy so that people need to actively “opt out” (eg, changing from chips to salad as a standard side dish on a restaurant menu, with chips only available as an option). Near the bottom of the intervention ladder, a full range of choices is available, but people are empowered to make beneficial choices. Choice can be enabled (eg, offering participation in “stop-smoking” programs, providing free fruit in schools and building cycle lanes) or the public can simply be provided with information (eg, good food labelling, campaigns to encourage adequate daily fruit and vegetable intake, and encouraging people to walk more). At the bottom of the ladder, the approach is to simply monitor the situation, but this may have its own adverse outcomes. The above policy options are not mutually exclusive. Implementing less restrictive policy options (such as information provision) can increase public acceptance of more restrictive (and often more effective) interventions. Australians have accepted compulsory seatbelts, random breath testing, increasingly tighter regulation of the advertising and sale of alcohol, and smoking bans in enclosed spaces. The Productivity Commission’s proposal for a comprehensive, coordinated and carefully sequenced package of reforms to gambling regulation is a recent example of the public health approach.4 The public has a right to better health. Evidence-based public health strategies, appropriately implemented, are vital to this effort. This may entail impinging on individual freedoms. However, when informed of the benefits, people are prepared to accept sensible curtailment of choice for a better life for themselves and the community as a whole.

Ken J Harvey MB BS, FRCPA

Anaesthetist Michael Keane says no In Melbourne, a prominent billboard summarises: “Alcohol does not cause violence. Blame and punish the individual”. Ironically, this simple message articulates a far more comprehensive understanding of the complete body of relevant knowledge than many public health academics who advocate reactionary, prohibition-like controls on the voluntary consumption of ever more products. Public health traditionally focused on the health consequences of unwanted phenomena. Nobody wanted to drink faeces-flavoured water, but they did want convenient disposal of sewage.1 In contrast, today’s public health focuses increasingly on restricting the active and deliberate consumption of desired products and services, thus imposing government lifestyle mandates (GLMs) on the population. Alcohol, fast food, cigarettes, shopping, soft drinks, gambling and other “vices” unquestionably bring utility as well as harm. What price for the enjoyment of, say, a night of alcohol intoxication? Only the individual knows the answer. The long-established principle of autonomy acknowledges that only the individual can apportion the appropriate weighting to each of the myriad factors in any harm–benefit calculation. GLMs are health interventions, and, like any intervention, need to be consistent with contemporary medical ethics. Sensationalist studies of harm are inadequate to justify enforcing health interventions against peoples’ will. Political scientist Eli Feiring summarises: “Given that respect for the autonomous choices of patients runs deep in modern healthcare, there are strong reasons to value the claim that competent and well-informed individuals are the best interpreters of their own interest and that they should be free to make choices others would regard as non-beneficial to them”.2 Furthermore, it is meaningless to present the sum of harm resulting from a product without reference to fault. A fully established societal and legal principle is that harm caused to oneself is treated differently from harm caused to others. There is certainly no academic basis to nihilistically accept that people who are “glassed” in the face or killed by drunk drivers are merely victims of alcohol-related harm. The solution is not to apply prohibitionist measures to collectively punish everyone. Unfortunately, it is this same failure to rationally distinguish between responsible and reckless use that frustratingly perpetuates the stalemate in the war on illegal drugs. Internationally, challenges to the limits of restrictions (of even smoking) are being countenanced, when the harm is only to the user.3 Similarly, the “freedom to endanger others behind a car wheel with a lead foot or a skinful”4 cannot be equated with the volitional use of products that harm only the user. A common straw-man argument implies that antipathy towards GLMs is a concern only about the overreach of government to run our lives. Admittedly, many public-health-inspired intrusions are minimal, such as the perennial example of seatbelts. But this example is then misused to justify extreme mission creep, up to and including prohibition-like measures. All behaviour can ultimately be coded as health-related in our system and, by reductio ad absurdum, a truly Orwellian state can be justified. Where does it end? Who decides? Yes, Prime Minister’s Sir Humphrey Appleby, or some other fictitious public servant? A more potent concern with the nanny state is the propagation of the “disease” model, which promotes society-damaging, malignant lack of personal responsibility — “it’s not my fault, it’s my disease”. Conceptualising the degree of responsibility for one’s behaviour is at the intersection of neuroscience, ethics and, ultimately, philosophy within the burgeoning field of neuroethics.5 If decision making is a function of the brain, should individuals really be held responsible for their decisions? With this neuroscientific and philosophical uncertainty, “addictions” should not be equated with other diseases in medicine. While the concept of addiction is complex and evolving,6 the current tendency to regard even the most reckless, selfish and antisocial behaviour as the biologically bound phenomena of a particular product is essentially just an expression of opinion and ideology. Regarding autonomy, does an individual who is smoking, drinking, gambling, eating junk food and being indiscriminate about sexual partners (“sex addiction”) really employ a sophisticated risk management equation and decide that the benefits outweigh the costs? Ultimately, public health advocates believe that such people are incapable of making the right decisions; we, the “elite” who know best, therefore have the right to decide what’s good for them. A further justification to usurp established ethical principles is based on the divisive and emotive argument that we have the right to control people because they cost us money in the form of health care expenditure. However, contradictory economic analyses on the real costs of alcohol, cigarettes and fatty foods abound. History and the human condition teach us that it would be dangerously naive to enforce interventions against peoples’ will on the basis of conflicting, often ideologically inspired economic analyses. Crucially, again, government overreach would then make it legitimate to forcibly treat individuals against their will, if it meant a reduction in government expenditure. Let me opt out.

Michael J Keane FANZCA

Aspiration pneumonia occurs most commonly in patients with a predisposition to aspiration (eg, those with neurological bulbar dysfunction). There is limited evidence regarding the involvement of anaerobes in most cases of aspiration pneumonia. Most patients respond to treatment for aspiration pneumonia without specific anti-anaerobic therapy such as metronidazole. Metronidazole has adverse side effects, and widespread use where not indicated can promote carriage of multiresistant intestinal flora such as vancomycin-resistant enterococci. Use of metronidazole may be appropriate in patients with aspiration pneumonia and evidence of a lung abscess, necrotising pneumonia, putrid sputum or severe periodontal disease.

Jason C Kwong MB BS, BMedSci · Benjamin P Howden MB BS, PhD, FRACP · Patrick G P Charles MB BS, PhD, FRACP

A view from the front line In Australia, medical colleges set the standards for specialty education within an accreditation framework managed by the Australian Medical Council (AMC). They also play a critical role in ensuring that vocational trainees are appropriately supervised and supported during their training. Despite the critical value of evaluation in specialty education, it can be difficult to obtain anonymous program feedback from trainees who fear being identified.1-3 In this context, the Australian Medical Association (AMA) Council of Doctors in Training undertook its Specialist Trainees Survey to ascertain trainee opinion on key aspects of vocational education. The April 2010 survey was an online, self-report questionnaire based on the AMC’s standards for specialty education programs. The survey methods are outlined in the footnote to the Box, and the full report is available online (http://ama.com.au/specialist-trainees-survey). Selected results (Box) show that colleges are performing well in many areas, including selection, alignment of clinical experience with learning objectives, and access to supervision. While there was a high level of satisfaction with work and training, several areas attracted negative results. These included appeals processes, capacity to raise concerns without fear of recrimination, recognition of prior learning, provision of remediation, responsiveness to cases of bullying and harassment, and cost. Concerns about appeals processes and fears of recrimination are consistent with the findings of a 2010 literature review and discussion at a recent AMC workshop on trainee feedback and course evaluation.3 It is critical that colleges adopt appeals procedures that conform to best-practice models, which characteristically ensure natural justice, have clear criteria, follow due process and minimise the risk of litigation. A concerning finding of the Specialist Trainees Survey is the perception of inadequate responsiveness to claims of bullying and harassment. Bullying occurs in Australian health workplaces,4 and trainees are at risk because distinctions between workplace and training supervisors can be blurred. It is critical that colleges have well defined and transparent processes for dealing with these matters, which are the responsibility of educators as well as employers. In the absence of such processes, trainees, supervisors and colleges remain vulnerable. The survey’s findings in relation to recognition of prior learning are not surprising, and reflect suboptimal integration of stages and pathways of training. Efforts to align and recognise components of clinical education will create efficiencies that will benefit trainees, colleges and health services. The survey’s most negative response was in relation to value for money of training fees. Further, 40% of respondents reported that the cost of their training program had caused them financial hardship. Ensuring reasonable costs for training and assessment is integral to minimising the adverse consequences of study debt.5 It is equally important that colleges are transparent about how they apportion fees. Notwithstanding the limitations of its methods, the results of this survey should help colleges reflect on their performance against the AMC standards for specialty education. Reassuringly, most areas attracted positive responses. The AMA plans to repeat the Specialist Trainees Survey every 4 years to continue to identify trends and emerging issues. Selected Specialist Trainees Survey* data Statement Agree or strongly agree Weighted average score I am satisfied with my training program 68% 0.29 The selection processes for entry into the training program are fair and transparent 69% 0.34 My training posts provide the necessary clinical experience to meet the objectives of my training program 75% 0.36 I am satisfied with the level of supervision I receive 84% 0.46 I am confident that I will not be disadvantaged if I raise issues of concern with my college 31% − 0.04 The college grants appropriate credit for relevant prior training and experience 25% − 0.09 The college provides unsuccessful candidates with appropriate remediation 16% − 0.14 The college has an effective appeals process 16% − 0.03 The college responds in a timely and appropriate manner to cases of bullying and harassment 11% − 0.04 The costs of the college training program represent value for money 23% − 0.30 * The survey had 55 items, each scored on a five-point Likert scale. All 10 649 hospital-based vocational trainees were eligible to participate, although only trainees on the Australian Medical Association database were directly sent a link via email. There were 538 respondents from 18 disciplines. Results for responses of “agree” and “strongly agree” were expressed as a percentage, and a weighted average score was calculated by dividing the sum of vote values (strongly agree, 1.0; agree, 0.5; neither agree nor disagree, 0; disagree, − 0.5; and strongly disagree,− 1.0) by total sample size.

Rob D Mitchell BMedSc(Hons), MB BS(Hons) · Alexandra L Markwell BSc, MB BS(Hons), FACEM · Rick J Fielke MB BS · Michael A Bonning BAppSc(Hons), MB BS · Andrew W Perry MB BS · Dror Maor MB BS

Health reporter Ray Moynihan welcomes the side effects of prescriptions to fight climate change As one of the planet’s most polluting populations, it’s perhaps understandable that many Australians have a good deal of fear and loathing about cleaning up our act. What might lift our mood for change is the growing evidence that strategies to reduce greenhouse gas emissions can directly improve the length and quality of human life. The World Health Organization is currently assessing the health impacts of different climate change mitigation strategies, and it’s come to some compelling, though still tentative, conclusions. The project, called Health in the Green Economy, has found that although many policies will have benefits for both health and the environment, “some of those having the largest impact on mitigation may also deliver the largest health gains”.1 In housing design, for example, natural ventilation and better insulation are obvious energy-efficient measures, but they may also reduce allergies, asthma and, in some places, illnesses associated with cold and damp. In kitchens throughout the developing world, cleaner, more fuel-efficient stoves could cut rates of childhood pneumonia and adult lung cancer and chronic obstructive pulmonary disease, while also reducing greenhouse gas emissions in the residential sector. In the area of transport, the WHO has some strong words about the health benefits of shifting focus from the private car to public transport, pedal-power and pedestrians. Such a shift, it says, could reduce respiratory and heart disease from air pollution, cut injuries from road accidents, and help prevent obesity, diabetes and cancer by boosting physical activity, potentially saving millions of lives every year. “A shift to active transport (walking and cycling) and rapid transit/public transport”, says the WHO review of the evidence, “can yield much greater immediate health ‘co-benefits’ compared with improving fuel and vehicle efficiency, yet the latter has been the mitigation strategy most emphasized by the Intergovernmental Panel on Climate Change”.1 The health care sector itself has been identified as another key climate change culprit, with estimates that it contributes perhaps 8% of all greenhouse gas emissions in the United States.2 Energy-intensive activities, gaseous wastes and huge use of water and transportation all contribute to health’s unhealthy carbon footprint, which until now has failed to attract much attention from those seeking to slow global warming. The WHO review again suggests win–win strategies, including the “greening” of health care facilities, by using more renewable energy and procuring fewer medical products that ultimately remain unused. “[The health care] sector is worthy of special attention due to its size, its growth, and its direct impacts on health”, says the review.1 Other groups, such as the global non-government organisation Health Care Without Harm, are already working on more “ecologically sound” alternatives to existing health care practices. One of its current campaigns is promoting more sustainable management of toxic medical waste in a demonstration project across eight nations, designed to reduce polluting gases and improve the health and safety of health care workers.3 A futuristic vision of health care in the post-peak oil world appeared in the BMJ last year, complete with dreams of less energy-intensive therapies and non-petroleum-based pharmaceuticals, delivered via hospitals that are accessible to all by foot, bicycle and public transport.4 Whether that future appeals to you or not, it’s clear that as we finally face up to climate change, the business of health will increasingly be exposed to the glare of environmental scrutiny. In Australia, the newly formed Climate and Health Alliance is stressing the potential win–wins for health and the environment,5 and in December the world’s first Global Climate and Health Summit will meet in Durban, South Africa. For anyone simply interested in an evidence-informed approach to decision making, the WHO is putting some fascinating new facts on the table that are helping to show which climate change strategies might have the biggest health benefits, and which carry risks. At the launch of the Health in the Green Economy project earlier this year in Washington, DC, a leading WHO figure called for a “new alliance” of policymakers across the climate change, housing, transport and health sectors. Let’s hope the call was heard loud and clear down under.

Ray Moynihan BA

The 2010 trivalent influenza vaccine (TIV) manufactured by CSL Biotherapies (CSL) was associated with increased febrile reactions, including febrile convulsions, among Australian children. CSL is one of the few manufacturers that use deoxycholate as the virus-splitting agent in the manufacture of TIV. Clusters of adverse events following immunisation (AEFI) have been previously linked to other deoxycholate-split TIV formulations in Europe and Canada. We hypothesise that suboptimal virus splitting or other mechanisms related to the use of deoxycholate may have played a role in adverse events linked to the 2010 CSL TIV. This hypothesis garners support from a recent United States Food and Drug Administration warning letter indicating that CSL failed to determine optimal splitting conditions for new virus strains and that assays to assess virus splitting had not been validated. While there may be other causes, the use of deoxycholate should be further explored. Comprehensive and timely investigations of AEFI, especially those involving children, are necessary to prevent their recurrence and to maintain public confidence in vaccination programs.

Heath A Kelly BSc, MB BS, MPH · Danuta M Skowronski MD, FRCPC · Gaston De Serres MD, PhD · Paul V Effler MD, MPH

Tobacco control advocate Simon Chapman explains how this public health reform will work In past months, Australian news audiences have been exposed to some exotic, presumed-extinct species on their screens and radios. After more than 15 years, the tobacco industry dodo is back and walking among us, attempting to fly. Australia’s pioneering plain packaging legislation has brought it out into public, in a desperate effort to prevent the fall of a domino that promises to cascade globally, ending the industry’s centrepiece of tobacco promotion: the lure of the pack. The University of California’s Stan Glantz once remarked that those who lead the tobacco industry are like cockroaches: “They love the dark and they spread disease.”1 Ever since the magnesium glare unleashed by the public release of its internal documents via the 1998 Tobacco Master Settlement Agreement in the United States, the industry has kept well out of public view, working behind the scenes to shore up its ebbing credibility. The court of public opinion told tobacco companies they were regarded as the most untrustworthy of all industries.2 Media appearances had become progressively humiliating as their spin was rejected. But the truth serum contained in the millions of now-public pages of court-ordered internal documents sealed their public fate. The industry had known tobacco killed, but had lied about it for decades. Their marketing divisions had underlined the vital importance of recruiting youth, and their chemists had been busy working to enhance the addictiveness of nicotine. Australia’s historic plain cigarette packaging legislation is a weapons-grade public health policy that is causing apoplexy in the international industry. It is likely to have little effect on heavily dependent smokers, who tend to be brand-loyal and less image-conscious, but without branding, future generations will grow up never having seen category A carcinogens packaged in attractive packs. Today’s 19-year-olds have never seen local tobacco advertising and youth smoking rates are at an all-time low. Plain packs will turbocharge this trend, making smoking history. Tobacco is a dying market in nations like Australia, which leads the world in comprehensive tobacco control. Australian Institute of Health and Welfare data released in July of this year show only 15.1% of Australians are now smoking daily3 — the lowest percentage ever recorded. From the beginning of the 20th century, when machine-manufactured cigarettes were first marketed, the advertising and packaging industries did all they could to portray cigarettes as a means of signalling personal identity to the young as they took up smoking. A callow youth who wouldn’t be seen dead with an Alpine felt assured by the promise of masculinity in pulling out a packet of Marlboros. Those not wanting the social opprobrium that can come with being showy had the iconic ordinariness of Winfield to clutch as their totem. Those wanting to affect retro stylishness have Peter Stuyvesant or Lucky Strike, and wannabes, any number of haute couture brands — designer carcinogens. But from next year, all cigarette packages will look the same, distinguished only by the brand name in standard typeface. The industry’s re-entry into policy debate has produced some high comedy. In advising government that plain packs will “not work”, it sought a role as a wise public health authority, when of course its fiduciary duty to its shareholders demands that it support policies that maximise use. It has commissioned reports that purport to show that 15.9% (1 in 6) of cigarettes being smoked now are illicit, when the latest Australian Institute of Health and Welfare national survey reports that a mere 1.5% of smokers use illegal tobacco more than half the time.3 Most of all though, its blank-cheque advertising campaigns, imploring the government to desist, say to anyone with half a brain that the industry knows plain packs will “kill their business”, as the cover story of a tobacco trade magazine put it in 2008. That’s precisely the plan. Tobacco kills one in two of its long-term users. The tobacco industry’s current undisguised panic shows that plain packs will hit them very hard. If she were to do nothing else, Minister for Health and Ageing Nicola Roxon has marked her tenure with this legislation, which has just been passed, unopposed, in the lower house of Parliament. It will stand in public health history as a major chapter of how governments put the health of the population before the corporate interests of a pariah industry. Just one disease caused by smoking — lung cancer — was rare before 1930. Over the next 50 years, it rose to become the world’s leading cause of cancer death. In countries like Australia, it is now on the wane. Plain packaging will accelerate its eventual demise as a major cause of death.

Simon Chapman PhD, FASSA

Obstetrician Brian Peat believes salaried doctors are favourably placed to provide best-practice care That any sane nation, having observed that you could provide for the supply of bread by giving bakers a pecuniary interest in baking for you, should go on to give a surgeon a pecuniary interest in cutting off your leg, is enough to make one despair of political humanity. George Bernard Shaw, The doctor’s dilemma (1906)1 A number of studies have consistently shown that fee-for-service payment is associated with an increase in the number of diagnostic tests and procedures performed when compared with payment by salary or capitation.2 It is more difficult to show that this is a bad thing; however, as imperfect tests are applied to populations of lower prevalence for a condition, we would expect more false-positive results. Also, since all procedures carry complications, we would expect there to be more complications.3 Even if salaried doctors, on the other hand, may be at risk of underservicing, this is addressed by peer review and outcome audit. Salaried payments have the advantage of lower administration costs. A substantial cost of the fee-for-service system is in recording individual items and arranging payments. This may be relatively simple when the item of service is a simple consultation, but more difficult when the items are complex. A portion of the cost is also in preventing fraud, rorting of the system and simple overservicing. In private practice, overheads, including rent and clerical staff, are substantial and may be important in giving a competitive edge in the pursuit of patients.4 Overall, the cost of a fee-for-service system looks greater than a salaried workforce; however, this is not necessarily so. It depends on supply and demand. General practitioners are in relatively high supply and receive low fee-for-service payments. Competition means they can only charge a modest patient copayment. Specialists, on the other hand, are in low supply and can generally charge large copayments. Salaried specialists, being currently in low supply, are able to negotiate relatively high salaries with money for holidays, professional development and superannuation. Salaried doctors have no conflict of interest in the doctor–patient relationship, which engenders a patient’s trust, and reduces anxiety for the practitioner. They are in a better position to consider all aspects of the patient’s health, and to appropriately delegate tasks knowing they will not be out of pocket. This is particularly an issue as we see more lifestyle-related, chronic illness that does not fit into the short-consultation model. Fee-for-service items created for the management of chronic illness are an improvement. However, they can still distort best practice if seen merely as dollar amounts requiring expenditure. In a practice where patients with chronic illnesses are treated, a doctor may be required to take on the role of team leader, a difficult role to provide an item of service for; however, it is one well suited to a salary package.5 A list of items of service that are funded by a third-party payer may, in practice, limit the doctor to offering only those options — otherwise, the patient may feel pressured to accept and cover the full cost of the service. If it were possible to provide a fee for service that was linked to an improvement in health, it may be difficult to attribute any improvement to the actions of the doctor. Unfortunately, in many areas of medicine, especially surgical procedures, good evidence from clinical trials that links health interventions to better health is lacking. Without such evidence, doctors may be likely to choose to perform the better-remunerated procedures. How does the method of payment affect relationships between doctors? When I started as a staff specialist I was told by a visiting medical specialist colleague that I was “a coat not a suit”. Nevertheless, I think if we perform our respective roles the relationships should not have problems. However, beware of salaried doctors undercutting doctors paid through fee-for-service arrangements at the local private hospital! Bitter fighting can break out between doctors if one craft group thinks it is getting a worse deal than another. It would be simple to change the current balance of numbers of salaried doctors and those receiving fee-for-service payments. Simply roll back some of the more outrageous subsidies to private practice, such as the thirty per cent health insurance rebate and the safety net, and direct that money to providing more salaried positions. Private hospitals face the difficulty of doctors acting in concert to resist moves by the hospital or the health insurers to lower costs by employing salaried doctors. Perhaps, as the medical workforce increases in number over the next few years, we will see a relative oversupply in some areas break this deadlock. Finally, in talking to our trainees and medical students, I have found there is enthusiasm for a salaried payment system. They do not see medicine as a business in which a craftsperson hawks their wares among the populace for a fee. Rather, they see themselves as providing a social service.

Brian B Peat MB BS, FRANZCOG

Urologist and AMA Victoria past president Douglas Travis believes fee-for-service encourages productivity and transparency From the perspective of doctors, patients and funders, fee-for-service is the best method of remuneration because it provides the best transparency, accountability and incentive for everyone. As a patient, you pay for what you get, and, as a doctor, you get paid for what you do. There are a number of claims for and against the fee-for-service model. I am focusing here on the specific issue of the best method of remuneration for a doctor’s efforts, and do not intend to address the separate issues of public versus private medicine, or free services versus out-of-pocket services. The first claim is that payment on a fee-for-service basis encourages overservicing.1 Theoretically, this could be true, but it is a small-volume threat. The reality is that the overwhelming majority of doctors are flat out doing the necessary work for their patients. They simply don’t have time to overservice. In fact, salaried remuneration encourages underservicing. While many salaried doctors do work excessive hours to cope with ever-expanding workloads, it is the human condition to watch the clock and not put in the maximum effort when you are paid by the hour. This risk outweighs the risk of overservicing under fee-for-service arrangements. In addition, the transparency of fee-for-service makes employers more accountable to doctors, reducing the potential for exploitation of doctors’ goodwill in both the public and private systems at all pay grades. Fee-for-service is also said to result in people being unable to afford medical care. However, the method of remuneration of doctors does not determine the cost of a service to the patient. For example, general practitioners who bulk bill are paid on a fee-for-service basis, but their patients have no out-of-pocket expenses. Conversely, private radiology and pathology companies often pay salaries to doctors, but patients pay out-of-pocket expenses. It is the quantum of remuneration to doctors, not the method, and the level of rebates from third parties that influence the end cost to patients. There are concerns that fee-for-service encourages doctors to try to provide more services in a given period of time, with resulting compromises to the quality of services provided. This is a theoretical problem, as proven by decades of high-quality fee-for-service work in Australia. Doctors have been and can be trusted to provide quality work in a fee-for-service environment. Fee-for-service is said to cause doctors to work excessive hours to their detriment. I contend that many salaried full-time doctors, in both the public and private systems, work excessive hours to their detriment, motivated by work addiction or greed. Work addiction and greed are difficult issues, which in themselves are the problem — not the method of remuneration. Another misconception is that, because fee-for-service is tied directly to patient services, there is no incentive for doctors to maintain continuing medical education (CME) or other quality improvement (QI) activities. However, QI can be incorporated into fee-for-service remuneration2 — for example, practice incentive payments are, in reality, fee-for-service payments related to QI. In any case, regulators are stepping into the quality field — CME is mandatory in order to maintain registration, and practice accreditation is spreading through all forms of medicine. Even if, in the past, fee-for-service meant you could theoretically ignore QI and CME, that era has gone. The area for which fee-for-service is not an appropriate funding model is research and teaching. Research work should be salaried. Likewise, remuneration for teaching should be time based, or if a doctor wishes to do it for nothing, so much the better. The fee-for-service model should have no impact on teaching and research. It might be argued that governments and other employers are ideologically opposed to fee-for-service, but what they are opposed to is uncapped, uncontrolled expenses, and to paying doctors remuneration deemed to be “excessive”. Most public-system fee-for-service schemes that have been stopped were uncapped and consequently led to budget blowouts, and were discontinued for that reason. In fact, governments are rushing headlong into fee-for-service remuneration at the macroscopic level in health, as shown in the establishment of the Independent Hospital Pricing Authority;3 it is just that it is called “activity-based funding”. Block funding (the equivalent of a “salary” model of funding) is on the way out because fee-for-service is better for all parties. In summary, I believe that fee-for-service remuneration encourages productivity, is more transparent and provides better accountability for all parties than a salary-based method of remuneration.

Douglas G Travis MB BS, FRACS(Urol)

People power and social networking tools for patients In 2004, Ben and Jamie Heywood launched a social networking site called PatientsLikeMe (PLM) (http://www.patientslikeme.com). They were motivated by their younger brother Stephen’s tragic journey with amyotrophic lateral sclerosis (ALS) and the desire to connect and share information with other ALS sufferers. Members of the PLM community create a profile to record and track their health over time, including quality of life, symptom control, and treatments and their efficacy and side effects. Members can also connect through online discussion, and the site has over 110 000 members with a counter on the homepage rising every few minutes. From April 2011, the site has opened up to all health conditions, after initially focusing on a few neurological disorders, such as ALS, multiple sclerosis and Parkinson disease. The savvy developers have produced an appealing Web 2.0 interface and the site links to other online platforms such as Facebook, Twitter, YouTube, blogs and free podcasts on iTunes. PLM’s stated aim is to help patients answer the question, “Given my status, what is the best outcome I can hope to achieve and how do I get there?”.1 The therapeutic effect of online communities is mixed2,3 and often not sustained, as are the effects of patients recording and monitoring their own health.4 PLM member postings declare the value of diarising their symptoms and treatments and also cite the importance of feeling that they are helping others by sharing their stories. Patients can print off a summary of their profile, called the Doctor Visit Sheet, to share with their doctor, providing a modern version of the patient diary. Members can opt to have their profile shared with other community members or to be publicly available. Some post video clips of their stories via YouTube, and many use the discussion forum facility, which has a code of conduct restricting industry and others from directly contacting patients. Members can delete previously entered information so that it is no longer visible to other community members, but PLM keeps the data indefinitely. Removing a profile requires contacting PLM staff and cannot easily be done independently by the member. PLM also promotes itself as a research tool, and this is where the site becomes more controversial. Patient profiles form a huge database of symptoms and treatment effects that can be accessed by researchers from academia and industry for a fee. PLM promotes this as a way to access patient data and “bypass around restrictive privacy rules that tie scientists in red tape”5 since data sharing is part of the user agreement for PLM community members. PLM openly declares itself as a for-profit company and was named by CNN Money in 2007 as one of the “top ten start-up companies most likely to upend existing industries — and spawn entrepreneurial opportunities”.5 Industry can buy access to particular PLM data, can deliver surveys through the site, can access PLM “leaders” (online expert patients) or pay for particular features to be added to the site for particular conditions. There are strong similarities here with Facebook, which has been criticised for profiting from companies accessing personal profile data for marketing and other purposes. Although PLM started out using Web 2.0 technology to find potentially effective treatments for rare conditions such as ALS through online data sharing, it now faces the challenge of balancing such goals with profit-driven ones. Used responsibly, PLM could be a revolutionary tool for medical research, particularly if the methodological limitations of its data are openly acknowledged. There is huge potential to identify case series for rare conditions and to develop hypotheses for effective treatments, which should be more rigorously assessed. One of the greatest strengths of the site is the wealth of patient-relevant outcome data, which may better inform researchers designing clinical trials. The large longitudinal datasets of chronic disease treatments can also provide adverse event data that may not occur in clinical trials due to limited follow-up periods and underpowering for unforeseen rare events. PLM monitors the site for serious adverse events and reports them to the United States Food and Drug Administration if appropriate. There are also rich data on non-pharmacological treatments used by patients and their perceived effects. The site can also link people to the clinical trials register to look for trials that they may wish to join. Although the PLM dataset is large and expanding, its degree of representativeness needs to be borne in mind. PLM claims to have 10% of all newly diagnosed ALS sufferers in the US on its site. Generalisability is an issue that PLM faces together with other researchers, as the opt-in requirements imposed by privacy legislation can significantly change sample characteristics.6 Like Facebook, PLM keeps extending the capabilities of its site, and members can invite their care team to view their profile. Is this a step towards online health care on social networks? There’s no doubt that social networking platforms for patients are potentially powerful tools for patient empowerment and for improving the efficiency of hypothesis development, patient-centred designs for clinical trials, and identifying potential serious adverse events of treatment. However, a number of questions arise. Should these platforms be left to the jurisdiction of private enterprise or should the non-profit or government sector address this need? Is there a need to regulate aspects of social network sites for patient protection or should people simply be better informed about the benefits and risks of social network sites?

Lyndal J Trevena MB BS(Hons), MPhilPH, PhD

21-Hydroxylase deficiency (21-OHD) is the most common cause of congenital adrenal hyperplasia, with an incidence of 1 : 14 000 live births and equal prevalence among males and females. Newborns with the most severe “salt-wasting” form of 21-OHD are susceptible to salt-wasting crises in the first few weeks of life. This is associated with morbidity and mortality. 21-OHD newborn screening (NBS) is currently performed in many countries. Despite several prominent medical societies recommending 21-OHD NBS, no state in Australia currently screens for this condition. We report a case that illustrates the need to reconsider including 21-OHD in NBS. 21-OHD NBS can be reliable, sensitive and effective in reducing morbidity and mortality.

Joyce Y Wu MB BS, MAACB, FRCPA · Sudeep MB BS, FRACP, DCH · David M Cowley MB ChB, FRCPA, FHGSA · Mark Harris MB BS, FRACP, MD · Ivan N McGown BSc, MIT, MHGSA · Andrew M Cotterill MB BS, FRACP, MD

Giving patients the highest quality of care must remain absolute “Time is an ocean, but it ends at the shore”, sang Bob Dylan. I think this is a good metaphor of how time seems to a freewheeling young person, who both feels that their youth will last forever and knows the truth of their mortality. However, for many clinicians, especially GPs, time is more like a series of small, leaky buckets in a bathhouse. We are the robed attendants whose job it is to clean each patient as best we can before the bucket runs out. They come anticipating a luxurious sunken bath, while we wonder if we can get away with a quick sponge to the armpits and crotch. Managing time effectively is one of the biggest challenges in clinical practice. Like water, it is becoming increasingly precious — our stress levels rise dramatically when we feel we’re spending too much of it. But sometimes we have no choice. Take Gary, a middle-aged man I’ve been seeing for a few months. He’s a health professional and seems a fairly typical bloke. Overweight and a bit grumpy, he’d had a few headaches and just wanted a blood pressure check. Not surprisingly, his blood pressure was elevated, and he had mild dyslipidaemia to go with it. He doesn’t smoke and admitted to only two or three schooners every now and then, but denied any other significant history — he just wanted his blood pressure controlled. There was nothing to suggest a neurological cause for his headaches, so I duly trotted out the lifestyle advice (which he already knew) and started him on an antihypertensive. Over the next 3 months his blood pressure improved a little and he said the headaches had lessened. Then he didn’t show again until it was time for a repeat script. His blood pressure was still suboptimal, and I began talking about adding in another drug. He told me he was thinking of changing jobs. At this point, I finally noted his bleary eyes, haggard face and dull expressionless voice, and realised that this would not be a one-bucket consult. John was deeply depressed and self-medicating with 10 schooners of full-strength beer daily. He was highly anxious at work, to the point of having panic attacks. He was subject to a range of post-traumatic stress symptoms from his recent close involvement with a variety of distressing incidents including violent suicides, horrific burn injuries and serious child abuse. After such events he had been the one organising care for traumatised staff, but had not himself been debriefed. In addition, he had major personal stress from conflicts in his own family. His overall distress was augmented by a deep shame at his inability to cope with situations. If this were an inspirational example for general practice trainees, this three-bucket consultation would result in Gary receiving successful treatment for his post-traumatic stress symptoms, leading to more moderate alcohol use and better control of his hypertension and other vascular risk factors. His workplace would retain an experienced staff member it can ill afford to lose. But reality is somewhat less committed to happy endings and, although I’ll do my best with this new information, I don’t yet know how Gary’s future will pan out. Only time will tell. Some patients do require us to spend time if we’re to have even a small chance of success but, much as we’ve come to disparage “6-minute medicine”, good practice isn’t always about giving more time either. Just as health expenditure if unchecked could expand to swallow the whole state and federal budgets, we all know patients who would gladly guzzle entire sessions for very little benefit. In the end, time management is a zero-sum game. You can try and cheat a bit by drawing on a bucket you’d put aside for yourself or your family, but in the end Gary’s extra buckets mean wet-wipes only for others in the waiting room. You can tell a lot about our professional values from the way we manage this precious resource. As clinicians we tend to be highly focused on our relationship with individuals rather than populations. Our highest loyalty at any particular moment is to the patient in front of us, followed by those in the waiting room, followed by the rest of our regular patients, with the general populace a distant fourth. We all know that tackling Australia’s undiagnosed mental health problems, for instance, would take far more GP hours than are available. Yet, we would strenuously resist any attempt to force a compromise between patient load and quality of care. Einstein may have shown us that time is relative, but our commitment to giving individual patients the highest quality of care remains absolute.

Simon Cowap MB BS(Hons), FRACP