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Women's health Letters 19 April 2010 Free

Pregnancy after aortic replacement graft

To the Editor: Pregnancy following aorto-iliac bypass or replacement grafting is uncommon, as most patients requiring this operation are beyond childbearing age. However, conditions may occur at earlier ages that necessitate such a procedure and, as the case described here illustrates, the surgery is no bar to pregnancy. In 1982, a 13-year-old girl presented to hospital after two episodes of abdominal pain. Ultrasound examination showed a large dumbbell-shaped retroperitoneal tumour widely separating the aorta and vena cava. Laparotomy revealed a large tumour firmly adherent to the inferior vena cava and completely surrounding the aorta. Biopsy showed it to be a ganglioneuroma. It was possible to separate the tumour from the vena cava but not the aorta, as no plane could be defined, and during the dissection a hole was made in the vessel. The involved aorta was resected and the tumour was able to be completely removed. The removed segment was replaced with a 10 mm woven dacron tube graft (compatible with the host aorta) from the infrarenal level to the aortic bifurcation. Five years later, the aortic graft thrombosed. Exploration showed no evidence of recurrence of the tumour, and the previous graft was replaced with a 14 × 7 mm gelatin-impregnated, knitted dacron bifurcated prosthesis from the infrarenal aorta to each common iliac artery. The patient had regular follow-up, including ultrasound and magnetic resonance imaging scans. In June 2007, after I had retired from vascular surgery, I was contacted by the patient (now aged 39 years), who was seeking information about her previous operations because she was 14 weeks pregnant and her obstetrician was concerned about the uterine blood supply. She had approached the hospital, but was told that her records had been destroyed. Fortunately, I still had my personal records of her previous surgery. The patient had required in-vitro fertilisation for conception because her uterine tubes were blocked. The pregnancy proceeded normally until the 36th week, when signs of eclampsia developed. Caesarian section was performed at 37 weeks and a healthy infant was delivered. A review of the literature revealed six other reported cases of pregnancy occurring in patients who had had previous aortic grafting for aneurysmal or atherosclerotic disease.1-6 Two patients had caesarean section and the others were delivered vaginally; all infants were viable. Possible concerns expressed by clinicians in cases such as this include compromise of the pelvic circulation, affecting foetal development; compression of the graft by the fetal head during delivery; uterine contractions contributing to graft occlusion; reduction of blood flow through the graft because of the patient’s position during labour; and false aneurysm formation at the anastomotic sites, with an increased risk of rupture. With adequate assessment and supervision by obstetric and vascular surgical teams, the outcome of pregnancy in women with a history of aortic grafting should be favourable.

H Reginald Magee

High rates of amputation among Indigenous people in Western Australia

To the Editor: There is generally a high level of awareness about the burden of disease associated with diabetes and its complications in Indigenous Australians.1 While high rates of renal failure, retinopathy and cardiovascular disease in Indigenous people are frequently emphasised, diabetes-related foot complications receive relatively little attention. As part of the Western Australian Department of Health’s Cardiovascular Health Network initiative (http://www.healthnetworks.health.wa.gov.au/network/cardio.cfm), we reviewed the trends in amputations for arterial disease or diabetes-related complications in Western Australia for the period 2000–2008. Discharges from hospital for any lower-limb amputations were identified using the relevant International Classification of Diseases, 10th revision, Australian modification, codes.2 Each individual was included only once, regardless of whether they had a further amputation. Age-standardised rates were calculated for Indigenous and non-Indigenous people residing in Western Australia, with and without diabetes. Toe or foot amputations were defined as “minor”, and amputations below or above the knee as “major”. Among those aged 25–49 years with diabetes, minor amputations were 27 times more likely, and major amputations 38 times more likely, in Indigenous people (Box). These data have not been validated by chart review, but there is no reason to suspect systematic bias. Nearly all (98%) of the amputations in Indigenous people were associated with diabetes. Although it is difficult to estimate the role of macrovascular arterial disease using administrative data, the literature suggests that peripheral neuropathy, ulceration and sepsis are important causal factors in these amputations.3 There is ample evidence that simple interventions such as foot screening, education and appropriate footwear are cost-effective measures to reduce amputations in patients with diabetes.4 Although there are some excellent programs and services for Indigenous people with diabetic foot problems throughout Australia, they are few in number, often fragmented and generally poorly resourced. Multidisciplinary foot clinics — considered international best practice5 — typically remain centred in capital city tertiary hospitals, requiring Indigenous people from rural and remote areas to travel long distances onto someone else’s land, with unfamiliar surroundings and devoid of family support. Although further research is required to better understand the underlying reasons for this disparity in amputation rates, there is a more urgent need to implement culturally appropriate versions of simple interventions among Indigenous people and ensure foot care is a standard component of comprehensive, multidisciplinary diabetes management. Age-standardised amputation rate* (crude number) by age group, 2000–2008 Minor amputations† Major amputations‡ 25–49 years ≥ 50 years 25–49 years ≥ 50 years Indigenous with diabetes 46.4 (93) 185.0 (118) 15.0 (30) 76.8 (49) Non-Indigenous with diabetes 1.7 (108) 28.9 (1408) 0.4 (26) 13.1 (638) Indigenous without diabetes 0.0 (0) 4.7 (3) 1.0 (2) 3.1 (2) Non-Indigenous without diabetes 0.3 (21) 6.5 (317) 0.3 (17) 12.8 (628) * Per 100 000 Indigenous and non-Indigenous people (irrespective of diabetic status) using the 2001 Census as the standard population. † Toe or foot amputations. ‡ Amputations below or above the knee.

Paul E Norman · Deborah E Schoen · Joel M Gurr · Marlene L Kolybaba

Women's health Letters 5 April 2010 Free

Surgery for stress urinary incontinence in Australia: current trends from Medicare data

To the Editor: The advent of midurethral slings (MUSs) has revolutionised surgery for female stress urinary incontinence. An MUS is a narrow, synthetic (usually polypropylene) tape that is surgically placed beneath the middle part of the urethra, traversing either the retropubic space or the obturator foramina to provide dynamic support in order to restore urinary continence. Medicare Australia data from 1994 to 2008 (Box) show that there was a 75% increase in surgery for stress urinary incontinence over this period, from 4000 to nearly 7000 cases a year, reflecting the increasing popularity of MUSs as a result of lower morbidity and shorter hospitalisation (day surgery). The rapid uptake of MUSs since 1999 has been matched with a rapid decline, since 2001, in use of the Burch colposuspension procedure. Colposuspension is an open abdominal or laparoscopic procedure in which the bladder neck is supported by elevating the paravaginal fascia using sutures to the ipsilateral iliopectineal ligament on both sides. This operation is done via an abdominal incision or through operative laparoscopy. There has also been a decline in the use of pubovaginal fascial slings and a small increase in urethral bulking procedures. Very few needle suspensions are performed in Australia. There has been a significant increase in the number of urodynamic procedures performed (including uroflow, cystometry and urethral pressure profiles), which may also be a reflection of an increased number of women presenting for treatment. It should be noted that these Medicare data reflect trends within the private sector only, and our data are not age- or sex-specific. Nor do they distinguish between the specialties of gynaecology or urology in their use of MUSs or between different midurethral slings used in Australia. Although Burch colposuspension and autologous pubovaginal slings were for many years considered the “gold standard” operations for stress incontinence,1 recent systematic reviews have shown MUSs to be just as efficacious2,3 and possibly more cost-effective.4 Regardless of debate about which operation may be best,5 MUS surgery has become the most common operation performed for stress urinary incontinence in Australia. Data from the National Health Service in the United Kingdom show a similar trend.6 However, changes in MUS use in Australia and internationally have not always been driven by good science. The remarkable popularity of the newer single-incision slings in the United States, despite very limited availability of clinical evaluation information, is of concern. Their popularity has been attributed anecdotally to the fact that insertion of a single-incision sling is an “office” procedure that attracts greater insurance reimbursement than procedures that are performed under anaesthesia or require hospital stays. Surgery for stress urinary incontinence has moved rapidly towards a minimally invasive approach, making it more appealing to all patients, especially those who are older or medically unfit. At present, new devices to treat stress incontinence and other pelvic floor problems are being introduced and extensively used without adequate clinical evaluation by good prospective randomised trials.7 Changes in surgical practice should be driven by good scientific evidence of safety and effectiveness, rather than commercial interests or government budgets. Trends in surgery for stress urinary incontinence (SUI), based on Medicare Australia data, January 1994 to December 2008 BCS = Burch colposuspension (item no. 37044). MUS = midurethral sling (item no. 35599). * Item nos. 35602, 37042. † Item no. 37043. ‡ Item no. 37339.

Joseph K Lee · Peter L Dwyer

Is informed consent necessary for computed tomography in children and young adults?

To the Editor: The risks of computed tomography (CT) are now well understood by radiologists and have been widely reported.1−3 Overall, the risk of fatal malignancy from a single CT scan (body, not including head) in children and young adults is about 1 in 1000 (varying from around 1 in 500 to 1 in 1500), and the high risk persists into the third decade.1,2 The risk is higher in children and young adults because there is time for malignancy to manifest (usually developing decades later), and their cells are dividing more rapidly and hence more susceptible. However, surveys of both patients and referring doctors show they have limited knowledge of the radiation risks from CT.4 Hence, most patients presenting for CT scans are not informed or aware of the risk. The High Court of Australia has determined that medical staff must inform patients of potential risks that the patient might regard as important.5 Patients, and their parents, may well consider a 1 in 1000 chance of fatal malignancy important. Most hospitals and clinics routinely recommend obtaining written, informed consent before administration of general anaesthesia or intravenous contrast agents. Some also routinely provide written information to parents or patients of the risks associated with general anaesthesia and anaphylaxis following administration of intravenous contrast agents. The risks of fatal malignancy developing later in life in children and young adults after a single CT scan are 1/500 for children aged less than 1 year, 1/1250 at 10 years, and 1/1600 at 20 years.1 This is 50–200 times greater than the risk of fatality following general anaesthesia (1/56 000)6 or administration of intravenous contrast agents (1/170 000).7 If informed consent is regularly sought before administration of general anaesthesia and intravenous contrast agents, then it is equally appropriate and consistent to seek informed consent before CT scans in children and young adults. Anything less may not be medicolegally sustainable. While patients rightly expect that referring doctors are able to balance the risks and benefits of any examination, they also rightly expect (and the High Court supports them) that any known risk will be revealed and discussed. Explicit and comparative information is best provided personally and in understandable written format by the referrer.8

John F de Campo · Margaret P de Campo

As mass media evolves into “masses of media”, what are the implications for our health?

To the Editor: Sweet and Simons are right to raise concerns about the quality and reliability of the health information available on the internet in this new digital age.1 Similar to the “old media” paradigm, the driving pressure is to maximise readership, thereby maximising advertising revenue. The task of providing content of sufficient volume and quality to meet the needs of readers permanently connected to the internet appears overwhelming. As an example of the way such pressure damages the quality of health reporting, we need look no further than the way Sweet’s health blog, Croakey, and its parent publication, Crikey, dealt with the 2009 H1N1 influenza pandemic. After initially calling for a rational discussion about the merits of the population-based vaccination program,2 Croakey and Crikey published a series of articles that either trivialised the severity of the H1N1 outbreak or focused on perceived problems of the vaccine or the program. There was no corresponding focus on possible benefits of vaccination or solutions implemented to minimise perceived problems with the program. Former Minister for Health Michael Wooldridge had a piece supportive of vaccination published,3 but this was immediately followed by a response from Sweet suggesting, without supporting evidence, that he was acting as an agent of CSL.4 So effective at rallying anti-vaccination supporters has Crikey’s campaign been that members of the anti-vaccine Australian Vaccination Network now copy in Sweet and Crikey on correspondence to the federal Minister for Health denouncing H1N1 vaccines.5 Although it is unlikely this negative reporting will have a major impact on H1N1 vaccine coverage, it adds a veneer of credibility to vaccine conspiracy material widely available on the internet. Sweet and Crikey would do well to consider the wider public health implications, beyond improving readership and advertising profit, of pushing their controversial and strident anti-H1N1 vaccine message.

Stephen B Lambert

As mass media evolves into “masses of media”, what are the implications for our health?

In reply: Lambert has previously raised similar concerns in comments published by Crikey and its health blog Croakey.1-3 Leading public health and medical experts contribute to Crikey and Croakey’s coverage of pandemic influenza. As has been noted in this Journal, there are many questions and controversies surrounding the pandemic and the policy response.4 It is a misrepresentation to describe Crikey and Croakey coverage as being stridently anti-H1N1 vaccination or a “campaign”. Indeed, I recently received a note of thanks from the Australian Government Department of Health and Ageing Media Unit for a “very fair report” in Crikey regarding an influenza vaccination safety issue (Department of Health and Ageing Media Unit, personal communication, 8 Dec 2009). Michael Wooldridge and CSL’s Director of Public Affairs, Rachel David, are scheduled to speak at a conference in Sydney on 24 March 2010 about their use of online media to promote pandemic vaccination.5 It cannot be controversial, in these times of heightened concern about conflicts of interest and their consequences, to suggest that if Wooldridge is publishing related comment, as in his Crikey article, any association with CSL should be declared.6 Additionally, I am regularly copied on emails or correspondence by a variety of individuals and organisations. This does not mean I am involved with these groups or necessarily support their work. Lambert is entitled to his views about the forces driving the media; my own is that an open, transparent debate about public policy, whether it relates to vaccines or other interventions, is important for the health of populations and of societies more broadly.

Melissa A Sweet

The new “Indigenous health” incentive payment: issues and challenges

To the Editor: In their article, Couzos and Delaney Thiele raise many good points with respect to Medicare Australia’s Practice Incentives Program (PIP) Indigenous health incentive.1 The funds in question are part of the “closing the gap” spending by the Rudd government. However, the central question is whether spending many millions of dollars of this allocation to add to the income of general practitioners (through a patient enrolment program and the generation of “care plans”) will in fact convert into greater access to, and greater utilisation of, health services by the Aboriginal and Torres Strait Islander population (hereafter referred to as the “Aboriginal” population). The authors correctly point out that most practices in Australia do not treat Aboriginal patients, and that the uptake of targeted, extended-primary-care items by Aboriginal people is much lower than in the general population.1 In most areas, apart from the most remote, the problem is not a lack of services, but the red tape that blocks Aboriginal patients from taking advantage of health services. Adding further layers of red tape, such as patient enrolment, care plans, and health assessments, will only make it harder for Aboriginal patients to access extra health care. For example, an allied health service, normally accessed by walking in off the street, requires a care plan plus a team care plan. Such red tape only adds to the burden of compliance — the problem that lies at the heart of the reason why so many Aboriginal patients fail to meet basic health outcomes. From an economic viewpoint, one needs to ask what could be done with the money that will go to the health provider for administration, rather than for actual clinical care. For example, paying a GP $500 to enrol a patient could instead pay for a significant amount of dental work, speech pathology, diabetes education or physiotherapy. The Department of Veterans’ Affairs (DVA) Gold Card offers an efficient, simple and highly efficacious model that would serve the Aboriginal population a lot better.2 Under the DVA model, doctors are paid a modestly higher rebate for treating veterans (or their families). However, the real benefit for DVA Gold Card holders lies in their ability to access an expanded pharmaceuticals scheme, a comprehensive range of allied health and medical equipment, free patient transport, and private hospital care. Under the DVA, such benefits are accessed with minimal paperwork for the referring doctors and patients. Therefore, the DVA model, in contrast to the PIP Indigenous health incentive model, better targets funds towards service delivery. It is time for politicians and the Department of Health and Ageing to adopt a DVA-style model for the Aboriginal population.

Aniello Iannuzzi

Whole-of-hospital response to admission access block: the need for a clinical revolution

To the Editor: We read with interest Walters and Dawson’s call for a clinical revolution to tackle access block1 and are heartened by the interest shown by general physicians in a problem that primarily affects the emergency department (ED). The efficient management of admitted medical patients is paramount to patient flow within the hospital, and “buy-in” from general physicians is essential. When considering any new model of care, it is important to note that longer patient assessments in ED by emergency doctors has a relatively small effect on access block; the claim that the length of assessments is a significant factor in access block has been established as a “myth” by investigators who have mapped process times.2 Therefore, it is unlikely that substituting one workforce of acute physicians for another would make any difference to overall patient flow through the ED. On the contrary, it is likely to be associated with increased costs3 and adverse effects on the emergency medicine labour supply.4 In addition, the ability and willingness of the general physician workforce to implement and sustain the newer role of “acute physician” is unknown. The root cause of access block lies in ward-bed shortages, ward processes and community capacity, which should be solved by improved flow processes across the continuum of care. Access block will not be solved by a second tier of acute physicians duplicating the role of emergency physicians. However, there are many aspects of Walters and Dawson’s model of change that would improve patient flow, in particular: improved rostering of medical staff; improved access to pathology and radiology services; and, perhaps, specific retraining of medical staff in the efficient discharge of inpatients. These aspects should be rigorously explored as we strive together to tackle access block.

Biswadev Mitra · Peter A Cameron · Pieter De Villiers Smit

Whole-of-hospital response to admission access block: the need for a clinical revolution

To the Editor: Walters and Dawson1 correctly highlight access block (hospital overcrowding) as a whole-of-system problem. Acute medical assessment and admission units (AMAAUs), or other similar incarnations in Australia and New Zealand, are part of the solution, although the evidence presented is low-level non-Australasian data. The reduced length of stay achieved by these units and reported in papers cited by Walters and Dawson would, if replicated in Australasia, produce additional capacity, improving bed availability and patient flow. As has been repeatedly stated: it’s all about available beds!2 However, Walters and Dawson’s article stretches well beyond the evidence in its approach to emergency department (ED) roles and the interactions between AMAAUs and EDs. None of the cited studies suggested that AMAAUs provide better environments than EDs for sick undifferentiated patients. None studied effects that AMAAUs have on ED treatment and none proposed interventions specifically designed to alter ED management. They essentially examined improved patient journeys for front-loaded AMAAU versus standard (slower) general medical inpatient care. In addition, Walters and Dawson imply that these changes related to introduction of the United Kingdom’s 4-hour rule. However, many references were either non-UK or not specific to the 4-hour rule. Rigorous research in an Australasian context would be required before adopting models from a different system. The authors promote a view that undifferentiated acutely sick patients bypass the ED to be managed by “new” acute-care specialists. No evidence is presented to support this change, and it is difficult to see how this would be a sensible policy for Australia and NZ, which have mature ED systems. Emergency physicians are specialists specifically trained and skilled in early diagnosis, management and disposition of the undifferentiated, unwell patient. What is required is a system that builds on the excellent start made by the ED, removes the blocks to patient care caused by waiting for beds in the ED and then continues to emphasise rapid diagnosis, early management, disposition and flow. This is what AMAAUs can deliver and why they should be effective. Australasian EDs already provide an exemplary service in a difficult, access-blocked environment. What patients need is sufficient hospital capacity — hospitals that provide enough appropriate beds. We look forward to seeing AMAAU staff meet this need in partnership with their emergency physician colleagues. In summary, it’s all about available beds, about having enough overall capacity and optimising patient flow to maximise bed availability.2 The only revolution required is for governments to recognise this fundamental precept.

David Mountain · Daniel M Fatovich · Drew B Richardson · Sally M McCarthy

Whole-of-hospital response to admission access block: the need for a clinical revolution

To the Editor: Although written from a United Kingdom perspective, the recent article by Walters and Dawson1 suggests a change in the clinical culture within hospitals, so that patient care and throughput can be improved. A critical factor in achieving change is the creation of an acute medical assessment and admission unit (AMAAU) within each district hospital. Characteristics of the AMAAU will “depend on local circumstances”: there is no one size that fits all.1 Because of Australia’s unique demography, and the number of communities beyond the reach of tertiary centres, many primary-care physicians (general practitioners and “rural generalists”) provide the continuum of care required by patients, both within the community and within their local hospitals (the acute admission, ongoing inpatient care and discharge planning). Twenty-first-century GPs deal daily with patients needing management of multiple comorbidities and the consequences of polypharmacy (the “sick general” and “complex elderly” clinical streams1). GP training prepares doctors for these responsibilities and could easily be expanded to include an AMAAU role for interested GPs, especially those in outer urban and major rural areas. The advent of AMAAUs is an opportunity to change the mindset in medicine: after 8 to 9 years of primarily hospital-based training, some GPs suddenly have no hospital access! This would seem to be a callous waste of talent and resources.

Frank R Jones

Whole-of-hospital response to admission access block: the need for a clinical revolution

To the Editor: Walters and Dawson1 highlight growing interest in new models of care aimed at ameliorating hospital-bed pressures and access block. They advocate acute medical assessment and admission units (AMAAUs) as a potential solution, and claim, principally based on the United Kingdom’s experience, that these units can significantly improve clinical care and patient outcomes. A recent systematic review confirms that these units (which have attracted several different synonyms) have promise, although controlled trials have yet to be performed, and publication bias remains a potential confounder.2 Experience with such units in Australia and New Zealand is growing, with more than 30 units in operation, and up to another 15 due to open over the next few years. Several national workshops conducted during the past 12 months have allowed staff of the units to share lessons and insights, and to debate how to balance service needs with resource availability. Operating standards for AMAAUs have been developed by the Internal Medicine Society of Australia and New Zealand (IMSANZ),3 which represents consultant general physicians. A recent survey shows the operations of Australasian units concord, in the most part, with these standards.4 We caution against Walters and Dawson’s suggested separation of AMAAU physicians into two streams — acute physicians working shifts, and ward-based general physicians responsible for patients requiring transfer from the AMAAU. Given that at least half of AMAAU patients will require transfer to inpatient wards, and many may warrant ongoing outpatient care even if discharged from the AMAAU, the need for continuity of care is paramount at the interface between the AMAAU and ward or clinic. To minimise the number of handovers and their attendant hazards and inefficiency, the medical team assessing and managing the patient in the AMAAU should ideally be the same team that provides ongoing inpatient (and indeed subsequent outpatient) care. This practice also eliminates any confusion around who is ultimately responsible for decisions about individual patient care, particularly for patients who remain in the AMAAU for any length of time. General physicians can acquire and maintain skills in acute medicine by making use of professional development programs sponsored by the IMSANZ. Clinical directors are needed in AMAAUs to oversee unit operations, develop policies and procedures, and provide capacity for rapid consultant response if on-call consultants are temporarily unavailable. The real challenge, to which Walters and Dawson refer, is the need for health care professionals to recognise that whole-of-hospital redesign solutions — which include AMAAUs — are needed, if access block in emergency departments is to be successfully overcome.

Ian A Scott · John W Henley

Whole-of-hospital response to admission access block: the need for a clinical revolution

To the Editor: The Journal took a significant step forward in publishing the three articles on access block in the 6 April 2009 issue.1-4 Walters and Dawson’s viewpoint article,4 in a later issue, touches on some ideas that will be useful in finding solutions to access block — ideas that some hospitals are implementing. However, I am not sure a microsolution aimed purely at acute medical patients can be called a whole-of-hospital revolution. The acute medical assessment and admission unit (AMAAU) is potentially a good idea. Fortunately, many hospitals all over Australia already have units that are highly efficient at the role that is proposed for it — they are called emergency departments (EDs). Most acute medical patients can be identified as needing admission after a few seconds in the ED by experienced emergency physicians. The remaining patients need some basic pathology or imaging service before a decision can be made, which should take an hour at the most. Having secondary inpatient units providing this role to the community via direct general practitioner referrals, as well as having some patients bypassing the ED by being cherry-picked by inpatient teams, may generate inefficient duplications of service. The AMAAU has merit, streaming patients to the right specialty and the right inpatient bed early in their presentation. Emergency physicians have largely known this for over a decade and these kinds of units have already been introduced in hospitals all over the country. Nepean Hospital, in western Sydney, has the PECC (Psychiatric Emergency Care Centre), AGS (Acute Gynaecological Service), MAU (Medical Assessment Unit), EDMAU (ED Medical Assessment Unit), EMU (Emergency Medical Unit) and ASU (Acute Surgical Unit), to name just a few acronyms. Unfortunately, this does not deal with the 20 patients in the ED, already admitted and sorted, waiting for an inpatient bed at 8 am on a Monday. Increased inpatient bed numbers to cope with the predicted acute ED admissions and the planned elective surgical workload must be the number-one priority. Once we have bed numbers to cope with demand, then we can plan how to use them. I propose my own revolution. We need to provide a true 7-day-a-week service to our hospital inpatients. Ward rounds should be conducted 7 days a week. All inpatient consults, including those of allied health practitioners, should be completed on the same day, including weekends. All complex imaging should be completed on the day it is ordered, not the next working day, with formal reports available the same day. Once we acknowledge that acute hospital medicine does not fit in with the 38-hour working week, then we can truly start acting as patient advocates.

James L Mallows

Comparison of adult patients hospitalised with pandemic (H1N1) 2009 influenza and seasonal influenza during the "PROTECT" phase of the pandemic response

To the Editor: The recent article by Chang and colleagues concluded that “the clinical course and outcomes of pandemic (H1N1) 2009 influenza virus are comparable to those of the current circulating seasonal influenza”, and that: “The high number of hospital admissions reflects a high incidence of disease in the community rather than an enhanced virulence of the novel pandemic influenza virus”.1 We are concerned that these assertions underemphasise the true severity of the influenza pandemic, and have led to inappropriate reporting in the media.2 The single-centre series reported by Chang et al had a small sample size and was almost certainly underpowered to detect important differences. It is also likely that some of the five untypeable patients who were categorised in the seasonal influenza group had had false-negative test results for pandemic (H1N1) 2009 influenza. Despite the small numbers, this study suggested that patients with pandemic (H1N1) 2009 influenza were younger and less immunocompromised than those with seasonal influenza; both of these characteristics of the patients affected may indicate that the pandemic virus is a more virulent strain. However, regardless of whether its virulence was greater, our significant concern is that our community will underestimate the real burden of the pandemic, which was substantial in Australia and New Zealand during the recent winter. In recent publications, we described more than 700 people admitted to intensive care units (ICUs) throughout these two countries with pandemic (H1N1) 2009 influenza.3,4 These were often young and previously healthy people, and many were pregnant women.3 Two-thirds needed mechanical ventilation for influenza-induced respiratory failure,3 and a smaller but substantial number developed rapidly progressive acute respiratory distress syndrome and required extracorporeal membrane oxygenation (ECMO),4 the most extreme life support available. This is not the normal pattern of influenza in Australasia. In comparison to a normal winter, ICU admissions for viral pneumonitis increased 15-fold,3 and the use of ECMO for acute lung injury increased 17-fold.4 Patients infected with pandemic (H1N1) 2009 influenza required prolonged stays in both the ICU and hospital and, despite optimal care, more than 100 died. ICU bed occupancy by patients with pandemic (H1N1) 2009 influenza ran as high as 19%3 in a system that normally runs close to maximal occupancy. There is a real risk that the pandemic will affect Australia again next winter or earlier, and we feel the Australasian medical community should not be misled into believing that the pandemic (H1N1) 2009 influenza virus is not virulent and has not been responsible for significant mortality and morbidity in a population not normally affected.

Andrew R Davies · Steven A Webb · Ian M Seppelt · Rinaldo Bellomo

Comparison of adult patients hospitalised with pandemic (H1N1) 2009 influenza and seasonal influenza during the "PROTECT" phase of the pandemic response

In reply: Our study found that both subtypes of influenza caused substantial morbidity and mortality, but that there was no difference in outcomes between patients infected with seasonal and pandemic (H1N1) 2009 influenza.1 The large numbers of cases of pandemic (H1N1) 2009 infection, and especially those requiring intensive care unit (ICU) management, is not disputed — 37 537 cases, 655 ICU admissions and 191 deaths in Australia had been reported as of 18 December 2009.2 However, this is not a function of enhanced virulence of the pandemic strain, but rather a function of vast numbers of infected individuals in a naïve population. The article by the Australian and New Zealand Intensive Care study investigators supports our conclusions, as they found no difference in outcome between pandemic (H1N1) 2009 and seasonal influenza.3 As specimens were tested in “real time”, RNA degradation is unlikely to have resulted in incorrect categorisation. The real impact of influenza has probably been under-reported before this pandemic, as virological testing of respiratory specimens has not been routine. Influenza per se is a significant disease, and thus appropriate planning, including resource allocation for ICU management and routine virological testing of respiratory specimens should be undertaken.

Iain B Gosbell · Sebastiaan J van Hal · Peter M Spencer · Ya-Shu Chang · Peter W Collett

Comparison of adult patients hospitalised with pandemic (H1N1) 2009 influenza and seasonal influenza during the "PROTECT" phase of the pandemic response

To the Editor: Chang and colleagues suggest that the clinical course and outcomes of patients infected with pandemic (H1N1) 2009 influenza virus are comparable to those with seasonal influenza infection, and that increased hospital and intensive care unit (ICU) admissions with influenza reflected a higher incidence of disease in the community rather than enhanced virulence of the pandemic influenza virus.1 However, this conclusion was based on an analysis of data from a single hospital, which did not examine whether the community incidence of influenza was increased or whether infection with pandemic (H1N1) 2009 influenza increased the risk of admission to a hospital or ICU compared to infection with seasonal influenza. Seasonal influenza co-circulated with the pandemic influenza strain during the recent influenza epidemic in New South Wales.2 We used the results of influenza tests (excluding rapid antigen tests) performed at eight major NSW public laboratory services to estimate the risk of admission to an ICU with pandemic (H1N1) 2009 influenza compared with seasonal influenza A infection. These public laboratories confirmed 95% of people admitted to hospital with pandemic (H1N1) 2009 influenza, and 84% of all laboratory-confirmed pandemic influenza cases in NSW. For the weeks ending 5 June to 2 October 2009, 38 060 specimens were tested for respiratory viruses, of which 7602 were positive on polymerase chain reaction for influenza A. Of these, 4172 (55%) were identified as pandemic (H1N1) 2009 influenza. During the same period, we collected data on all patients admitted to an ICU with influenza A infection.3 In total, 274 patients with influenza A were admitted to NSW ICUs — 229 with pandemic (H1N1) 2009 influenza, 38 with seasonal influenza A and seven with unsubtyped influenza A infection. Excluding the seven unsubtyped influenza A cases, we calculated a relative risk of 4.9 (95% CI, 3.5–7.0) for admission to ICU with pandemic (H1N1) 2009 influenza compared with seasonal influenza A infection. A sensitivity analysis assigning the unsubtyped influenza A cases admitted to ICUs to either pandemic (H1N1) 2009 influenza or seasonal influenza A produced no significant change in our findings, with a relative risk of admission to ICU with pandemic influenza compared with seasonal influenza A infection of 5.1 (95% CI, 3.6–7.1) and 4.2 (95% CI, 3.1–5.7), respectively. Although we attempted to collect data on all patients admitted to an ICU with influenza A infection, repeated testing for pandemic (H1N1) 2009 influenza in ICU patients may have resulted in identification of pandemic (H1N1) 2009 influenza in a greater proportion of ICU patients than community patients. However, our results suggest there was a significantly increased risk of admission to an ICU with pandemic (H1N1) 2009 influenza infection compared with other seasonal influenza A strains circulating in NSW. Given the potential for a subsequent pandemic wave, this provides support for maximising rates of community vaccination with a pandemic-specific vaccine.

Craig B Dalton · Michelle A Cretikos · David N Durrheim · Ian M Seppelt · William D Rawlinson · Dominic E Dwyer

A pandemic response to a disease of predominantly seasonal intensity

To the Editor: Kelly showed that the pandemic (H1N1) 2009 influenza epidemic experience in Victoria was similar, overall, to a moderately severe influenza season.1 As with seasonal influenza, 0–4 year olds had the highest hospital admission rates,2,3 with those in the first year of life most likely to be admitted to intensive care units (ICUs). “Swine flu” did have differences to seasonal flu, with “younger” people having disproportionally more serious illness.2,3 However, these younger groups were not necessarily what most would regard as young. Eighty per cent or more of deaths associated with pandemic (H1N1) 2009 influenza were among those aged over 35 years, and most had identifiable risk factors.2,3 The peak 5-year age group for ICU admissions was 50–54 years.2 Those aged over 65 years seemed relatively protected — presumably because most had pre-existing immunity resulting from infection with H1N1-type viruses circulating since 1918. Pre-existing immunity was also not uncommon in others. In 18–65-year-olds, 30% had protective antibody levels to pandemic (H1N1) 2009 influenza before vaccination.4 Using data from New South Wales, we can ascertain the severity of pandemic (H1N1) 2009 influenza in different age groups.2 In NSW last winter, 1214 people were hospitalised, 225 were admitted to ICUs and 48 died with pandemic (H1N1) 2009 influenza (17.2, 3.2 and 0.7 per 100 000 population, respectively). Pregnant women had a 10 times higher risk of death (1.4 per 100 000) than other women of their age. For the overall population aged under 40, the death rate was 0.4 per 100 000, with most having identifiable risk factors. Thus, the death rate for those aged under 40 years, but with no known risk factors, was about one per million people. Most of the mortality predictions for this epidemic have been consistently wrong and exaggerated. Some were suggesting 10 000 deaths in NSW alone.5 These, and other predictions of second and third killer waves, have generated needless fear and inappropriate responses.6 Many experts and even health departments were postulating that more than 20% of the population would become infected, with an associated case fatality rate of 1% or more. That translates to a population mortality rate of 200 per 100 000 people, which is 300 times higher than what actually occurred. We need to learn from our recent experience so we can better plan and act in the future. Analysis such as that performed by Kelly is essential if we do not want to repeat the mistakes we made during this pandemic, caused by a virus of relatively low virulence.

Peter J Collignon

Statistics Letters 15 March 2010 Free

Smoking history is clinically determinative and should be recorded

To the Editor: The debate raised by Sitas and colleagues about whether smoking status should be recorded on death certificates1 represents data acquisition at the last point. What needs to be considered is not the merits of the proposal, but the systematic failure to record this crucial data in patients’ clinical records. The argument I present here concerns cancer, but may be extrapolated to other smoking-related diseases. The absence of smoking history from the clinical records of patients with cancer up until now is understandable. Unlike the situation with infectious diseases, causative agents have had no relevance to the prognosis or the treatment of malignancy. Even if this pregenomic outlook persisted, the evidence we now have, showing that smoking affects response to therapy (eg, in prostate cancer),2 would warrant documentation of smoking history for every cancer patient. Among developed countries, the risk attributable to smoking in lung cancer is 70%–90%. In single-gene terms, polycyclic aromatic hydrocarbons and tobacco-specific nitrosamines such as 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone mediate malignant transformation by point mutations in onocogenes and tumour suppressor genes, typified by G-to-T transversions in codons 157, 158, 245, 248 and 273 of TP53; mutations in the KRAS gene and in the gene for epidermal growth-factor receptor (EGFR) are likewise relevant.3 Enough distinction can thus be made between smoking-related and non-smoking-related lung cancer to identify two entities.3 Patients with non-small-cell lung cancer, with exon 19 and 21 mutations in the EGFR gene are typically non-smokers, and their tumours have an 80% response rate to erlotinib.4 Indeed, these tumours respond better to chemotherapy than in patients lacking such mutations.4 As the single-gene era closes, smoking history will be required for all relevant biospecimens to avoid making genomic-wide data on pathways consequent on tobacco-related etiology — representing hundreds of tumours — inaccessible.5 Tobacco smoking causes cancer of the oral cavity, oropharynx, nasopharynx, and hypopharynx, oesophagus (adenocarcinoma and squamous-cell carcinoma), stomach, colorectum, liver, pancreas, nasal cavity and paranasal sinuses, larynx, lung, uterine cervix, ovary (mucinous), urinary bladder, kidney (body and pelvis), ureter and bone marrow (myeloid leukaemia), and possibly causes female breast cancer.6 The prospect of genomic-wide data for these tumours not being accompanied by data on smoking is daunting. The case for smoking data in relation to clinical trials has been made previously.7 Beyond this, the immediate goals for Australia are that smoking history be recorded for tobacco-related malignancies in hospital-based tumour-specific clinical cancer registries and for biospecimens. The need is for the adoption of uniform national vocabulary and coding methods. This will require leadership by an authority such as the National Health and Medical Research Council (NHMRC), the Cancer Council Australia, the Clinical Oncological Society of Australia, or Cancer Australia.

Bernard W Stewart

An open letter to politicians on climate change and obesity

To the Editor: As health professionals, we urge Australian politicians (and the public) to recognise the overlap in the underlying cause of two great health threats that our population now faces: the rise of obesity and its life-threatening disease consequences, and the great threats to health from global climate change.1-3 Big health gains have been made since the onset of industrialisation. However, we are now seeing the emergence of health risks caused by excesses in market-driven consumerism (including the consumption of energy-dense processed foods), energy-subsidised exertion-free living, an over-arching preoccupation with gross domestic product and (particularly relevant to climate change) population growth.4,5 In light of our profession’s long experience with the smoking–disease debate, we recognise the serious threat posed to population health by the well financed, doubt-fostering opposition of vested interests. In the case of smoking, it took 50 years and several million deaths to progress from acknowledgement of the health hazard to application of effective interventions. With climate change, we lack the luxury of time — and the stakes are much higher.6 Hence, a prudent, precautionary strategy to tackle the big issues is essential. We propose two initiatives: Convene a high-level, ongoing forum to discuss post-growth alternatives to unsustainable, consumption-based growth as the economic norm. This should involve health and social scientists, among others, and economists prepared to objectively take into account the real environmental costs of our actions; and Convene a multidisciplinary taskforce to develop an Australian population policy. Population is a key driver of energy use, greenhouse pollution and resultant ill-health.7 Despite the apparently widespread bias against public discussion of population issues, the topic is now attracting renewed attention and the debate should be facilitated. The irony of adopting a “no change” approach to these two issues is that, if this happens, involuntary change to everyone’s lifestyle will become unavoidable. We must seek a sustainable economic system and stable population size that ensures prosperity without endangering both health and environmental quality.8 For the moment, our actions are seriously damaging our planet and our children’s health. One in three children born today will become obese and/or diabetic in their lifetime, and the population at large will face increasing health risks from climate change.

Garry J Egger · Boyd Swinburn · Fiona Stanley · Kerryn Phelps

National registration legislative proposals need more work and more time

To the Editor: Having been closely involved with the initiation of the practitioner impairment and performance processes of the New South Wales Medical Board, I appreciate Breen’s generous remarks about the efficiency and fairness of the existing medical boards’ processes.1 In addition to wholeheartedly endorsing his concerns about the proposed medical regulation legislation, I consider that the profession should not lose sight of the origin of these “reforms” — the Productivity Commission’s report on the health workforce.2 This government “workforce” initiative is far removed from the concerns of any registration body — namely, “standards”. Our medical boards have hitherto rightly divorced themselves from workforce considerations. The profession should be concerned that an inquiry into the health workforce has resulted in a national standards body. This mismatch suggests a hidden agenda behind the new legislation to be adopted by all states and territories. Can our governments, Labor or Coalition, be trusted not to combine their powers over the new registration authority and over Medicare to exercise ham-fisted controls over doctors? Australians have already suffered the disastrous Wooldridge reduction in Medicare provider numbers in 19963 — resulting in today’s scramble to train more doctors. Breen says that most doctors have not opposed the proposed scheme.1 As one of the minority who do, I claim that the Emperor has no clothes. The devil is not in the detail, but in the principles. Breen correctly identifies the only valid, but weak, argument for national registration — that “the existing regulatory system [is] somewhat inefficient in terms of interstate mobility”.1 Australia’s health care problems relate primarily to lack of coordination between governments,2 not to standards. There is little regarding standards that could not have been ironed out by the state and territory medical boards and the Australian Medical Council. We are about to witness a horrendous waste of public money by governments whose primary goal, I suspect, is control over our profession — over our numbers, over our education, over our registration, over our postgraduate training, over our standards, and over the nature and location of our eventual practice of medicine. Today’s and tomorrow’s doctors have my sympathies.

Peter C Arnold

Ethics Letters 1 March 2010 Free

A case study evaluation of ethics review systems for multicentre clinical trials

To the Editor: The evaluation by Hicks and colleagues of the centralised ethics review system in New South Wales1 codifies important additional time delays facing researchers conducting multicentre trials that include NSW. These delays have direct financial consequences that continue to limit the viability (especially when staff are on time-limited grants) and productivity of multisite research in Australia, without adding value to the ethical conduct of the research.2 There is also inconsistency between the approaches of the lead ethics committee (LEC) and site-specific ethics committees in the way they deal with protocol amendments and adverse event governance, further compounding the delays in initial review. Five multicentre clinical trials are currently being conducted by the Palliative Care Clinical Studies Collaborative (PaCCSC),3 a national initiative to improve the evidence for symptom therapeutics at the end of life. Submissions for ethics review occurred between May 2008 and July 2009 across nine sites in five states. As in the study by Hicks et al,1 ethics review submissions included the NSW LEC, but because these submissions were more recent than those reported by Hicks et al, they were submitted on the National Ethics Application Form (NEAF). Hicks and colleagues state there is benefit in standard documentation, but using the NEAF does not reduce the need for collating complete sets of documentation for each site-specific approval and any subsequent amendments or adverse events.4 For the PaCCSC, LEC and site-specific review in NSW achieved approval in a median of 119 days (range, 76–209), compared with 107 days (range, 6–172) for individual committees in other states. Hicks and colleagues1 did not quantify the costs generated by these delays. Given that staff are often employed to prepare ethics submissions and then retained for the definitive study, additional delays in approval are costly, especially with finite, competitive grants funding. Costs of multisite ethics review applications have previously been quantified in Australia,2 but the additional delays in NSW from the requirement for site-specific approval are estimated to have cost the PaCCSC about $4000 per study per site in salaries and on-costs. Across three NSW sites and five studies, $55 000 has been spent without measurable ethical or research governance benefits. Theoretically, LEC review should streamline protocol amendments and adverse events reporting, as they are the responsibility of the LEC. But although protocol amendments are supposed to be reviewed only by the LEC, some site-specific committees continue to insist on approving all amendments.4 Efforts to consolidate adverse event reporting have made some progress.5 All adverse events are reported to the LEC for review, and any required response should be shared with site-specific committees. Again, some non-lead sites continue to insist on separately reviewing adverse events rather than using the LEC as intended.

Tania Shelby-James · Meera R Agar · David C Currow

Ethics Letters 1 March 2010 Free

A case study evaluation of ethics review systems for multicentre clinical trials

To the Editor: Hicks and colleagues presented a study contrasting the ethics review system in two multicentre trials.1 They concluded that the introduction of a centralised ethics review process in New South Wales did not reduce the overall time taken to receive approval, but did help to reduce the time and resources involved in preparing applications. We are establishing a multicentre trial to prospectively evaluate and refine a model to predict patient outcomes after endovascular aortic aneurysm repair.2 This will involve collaboration between vascular surgeons at over 40 sites throughout Australia, one site in the United Kingdom and six sites in New Zealand. We, along with Hicks and colleagues, have experienced difficulty in establishing our multicentre trial. Multiple individual ethics applications have been submitted to human research ethics committees (HRECs) throughout Australia. The National Ethics Application Form (NEAF) was created to minimise inconsistencies and reduce the time and resources required when submitting ethics applications to multiple HRECs. Although the NEAF was designed to increase efficiency and quality,3 in reality it has done little to facilitate the submission process. It has been useful in NSW and Queensland, which have processes to allow the review of multicentre trials, but few HRECs in other Australian states accept the entire form, and often they have their own specific requirements. This has resulted in increased costs and time, as well as different interpretations of the trial protocol — effects that Hicks and colleagues found were reduced with a centralised ethics system. We are at least 9 months behind schedule in establishing our trial after having submitted over 25 individual applications. This has resulted in substantial losses in patient recruitment and research time. Other researchers have also reported on the excessive time and resources required to submit ethics applications.4 Like Hicks and colleagues (and no doubt other researchers), we are advocates of the Harmonisation of Multi-centre Ethical Review (HoMER) initiative.5 This national system would allow single ethics review that would be recognised by all institutions participating in a collaborative research project, without re-review by their institutional HREC. It is uncertain how many HRECs will adopt the HoMER initiative, but we remain optimistic that HoMER can solve problems that the NEAF has not. Central coordination of the ethics review process may help standardise documentation, as demonstrated by Hicks and colleagues, but clearly other factors, such as the time required for approval, need to be addressed.

Kate L Fitzpatrick · Margaret Boult · Robert A Fitridge

Ethics Letters 1 March 2010 Free

A case study evaluation of ethics review systems for multicentre clinical trials

To the Editor: Hicks and colleagues are to be commended for reporting the benefits of the single ethics review system for multicentre trials in reducing the time taken for review, reducing unnecessary duplication of effort, and standardising documentation.1 They based their analysis on the overall time to approval, which included both an ethics and a governance component. The single ethics review model introduced by NSW Health in July 2007 separates scientific and ethics review from business or governance review (which requires site-specific approval). The Australian Research Ethics Database, developed by Infonetica for NSW Health, is used by the Cancer Institute NSW Clinical Research Ethics Committee (CREC) to track and manage multicentre research projects. It uses a 60-calendar-day clock to measure the time from submission to approval.2 The 60-day period sets a benchmark and represents a reasonable target review time. This clock stops, for example, when the CREC has sent a letter to the investigator and is awaiting a response. This method of measurement makes the total number of days for ethics review even shorter — for example, for the CO.20 trial described by Hicks and colleagues,1 the total number of days would be 66 rather than the 77 days they reported. It should be noted that if the CREC, which I chaired, sought changes to the participant information sheet after the first review of a research submission, the response was approved by the executive of the committee between full committee meetings. We used executive review more extensively than other committees to save time. This and other efficiencies, such as reducing the time between submission and the first ethics committee review and using a paperless review system, make it more likely that we will achieve a review time of less than 60 days as the committee becomes more experienced. This makes the adoption of a single ethics review system even more attractive.

Ian N Olver

Ethics Letters 1 March 2010 Free

Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry

To the Editor: Mitchell raises issues that strongly reflect on the professional standing of the medical profession.1 His particular focus is on the pharmaceutical industry, and on much needed changes as highlighted by Medicines Australia.2 Similar concerns exist in the medical technology industry where the transparency of relationships is becoming increasingly important. Mitchell highlights the fact that self-regulation by the medical profession has been largely ineffective.1 In this day of international corporate activity in the delivery of health care, the declaration of the Hippocratic Oath is no longer sufficient. The Royal Australasian College of Surgeons (RACS) published a code of conduct in 2006.3 This has been supplemented recently by the code of conduct of the Australian Medical Council.4 Separately, the Medical Technology Association of Australia has published its guidelines for industry groups.5 However, the dominant criticism of these documents is that compliance is voluntary. The RACS believes it is critical that the profession takes leadership in this complex issue to ensure that trust is maintained in the patient–doctor relationship. Consequently, we have recently expanded our code of conduct with a comprehensive policy dealing with interactions with the medical technology and pharmaceutical industries.6 We are introducing a sanctions policy to strengthen compliance. If there is a breach of the guidelines, the fellow or trainee concerned will need to confirm ongoing adherence to the RACS code of conduct. If there is a repeat offence, then cause will need to be given as to why the fellow should not have his or her fellowship removed or the trainee should not be dismissed from the training program. As professionals, these issues of integrity, transparency and trust are fundamental. The doctor–patient relationship must be our primary focus, and should not be violated by any perceived or real conflict of interest.

Ian R Gough · Ian Dickinson · Guy Maddern · Michael Grigg · David J Hillis

Ethics Letters 1 March 2010 Free

Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry

To the Editor: There is no doubt that the relationship between doctors and the pharmaceutical industry, described by Mitchell,1 is a complex one. Mitchell states that: “There are few, if any, analogies for the relationship between the medical profession and the pharmaceutical industry”.1 We contend that, as medical professionals are to the pharmaceutical industry, nutritional health professionals are to the food industry. Nutritional health professionals, like medical professionals, span the health care spectrum — from research and public health to tertiary care — and include doctors, dietitians, nutritionists and nurses. The food industry is more expansive than the pharmaceutical industry, encompassing primary producers, manufacturers, retailers and parts of the pharmaceutical industry. Some definitions include alcohol as part of the food industry. As well as this difference in magnitude, there are other substantial differences between the pharmaceutical and food industries. Contact between the food industry and health professionals is ubiquitous and unavoidable, but lacks the oversight provided by the, albeit voluntary, Medicines Australia code of conduct.2 It is unrealistic to suggest that health professionals should be completely divorced from the food industry. The alcohol industry is, however, the exception.3 Appropriate engagement between health professionals and the food industry has the potential to improve population health.4 Product reformulation (to improve the nutrient profile, such as reducing salt or fat content) and repackaging (to make smaller portions) are examples of successful partnerships between health professionals and the food industry. The food industry must work with health professionals to respond to consumer demand for healthier foods. Yet many of these foods are still of questionable nutritional quality, or of benefit only in very specific cases. Medications, on the other hand, must be proven before they enter the market. Finally, the food industry is able to advertise directly to the public and use health professionals to promote their products. This creates opportunities for endorsement — perceived or otherwise — of specific foods or brands by key opinion leaders, like doctors or sporting icons, who have varying degrees of nutritional expertise but are nevertheless viewed by the public as credible. Increasing rates of obesity legitimately prompt greater scrutiny of food industry activity. Analogous to the relationship between the pharmaceutical industry and doctors, it is equally necessary to “. . . expeditiously formalise a relationship of integrity and transparency . . .” between health professionals and the food industry.1 A code of conduct, equivalent to that of Medicines Australia, may be a necessary next step.

Iain S Pratt · Clare L Hughes · Terry J Slevin

Ethics Letters 1 March 2010 Free

Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry

To the Editor: In his article on the relationship between doctors and the pharmaceutical industry, Mitchell highlights moves to bring about greater transparency.1 While such moves are important, they do not go nearly far enough. Mitchell states that “it is not the relationship between medical practitioners and the pharmaceutical industry per se that is the problem, but how that relationship is enacted”.1 I disagree. The marketing activities of pharmaceutical companies are often justified by reference to the role that they play in the development of new medications, summarised in the statement “we need them”. In fact, the vast majority of the world’s most valuable medications were discovered and, in most cases, developed without pharmaceutical company involvement. Even recent advances, such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, originated with the brilliant work of researchers in the basic biological sciences.2 The progression from discovery to the development, testing and approval of a new drug does require large investments by pharmaceutical companies, but they do this for commercial reasons, in the hope of delivering profits to their shareholders. Naturally, they endeavour to promote their products and maximise their profits. As Mitchell outlines, their means include gifts, honoraria, sponsorship of events, “key opinion leaders” and “ghost writing”.1 As Mitchell also outlines, it is well established that all these manoeuvres are effective in altering doctors’ prescribing practices.1 Mitchell recommends that “we go down the route of disclosure of earnings from industry”.1 But is transparency enough? Is it enough to read that the keynote speaker at a symposium received an honorarium from a pharmaceutical company? Is it enough to know that delegates’ meals, entertainment or travel were paid for by a pharmaceutical company? Is it enough to know that your pen was provided by the manufacturer of X? (Isn’t that why the company’s name is written on it?) The fact that we need pharmaceutical companies to develop new drugs does not justify any of these activities, all intended to influence our decisions about whether and when to use their products. The fact that pharmaceutical companies cannot advertise or sell directly to their customers (ie, patients) in no way justifies marketing through intermediaries (ie, doctors and pharmacists). The recent report of the Association of American Medical Colleges is clear and forthright in proscribing many of these activities.3 Mitchell summarises their recommendations nicely, so I am surprised and disappointed that he does not go on to recommend proscription himself, rather than just transparency.

Richard Kelly Barnes

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