Editorials

Reforming the law on expert evidence The process of reform should involve the medical profession MJA 1998; 168: 53-54 Nowhere in the interface between medicine and the law is conflict more evident than in court. Although the two disciplines appear to have one thing in common -- to seek "the truth" -- the truth as relevant to medicine may well differ in nature from the truth as relevant to the law. Further, the approaches used by the two disciplines to establish their respective truths are fundamentally different. Common law process is based on an adversarial system in which opposing parties present evidence to a judge or jury who determine the outcomes. Litigants construct their cases largely by selecting evidence that is advantageous to themselves, rather than the "absolute truth". In contrast, Western medicine is based on scientific evidence. It seeks to establish its "truth" through rigorous scientific methods which are foreign to the legal profession in its training and practice. In the curial interface between medicine and the law, science is moulded into an uneasy and unnatural use within a system of intellectual combat alien to the scientific method. Enmeshed in this process are expert witnesses. The task of the expert witness was characterised by The Hon. Gordon Samuels, Governor of New South Wales and past President of the New South Wales Court of Appeal, in his 1997 AMA (NSW) Oration Medical truth and legal proof (in this issue of the Journal). He described this task as twofold: "to furnish basic scientific or technical data", and "to present inferences and conclusions from the facts which the judge or jury, for lack of specialised knowledge, cannot draw themselves".1 The duty of experts is to the court. They should impartially assist the court to understand the technical evidence, and not act as champions or advocates for the instructing and paying party. Understandably, some experts may find it difficult to recognise the need for impartiality and to accept this need if they have assisted in preparing the case before trial. The challenge to the trial judge is to ensure that the expert is qualified on the issue before the court and that only relevant and reliable opinions are accepted from that expert. The problem is that the procedural rules relating to evidence permit the judge a wide-ranging power of discretion to carry out these duties. There is no threshold test in common law for the admissibility of expert evidence which takes into account its reliability. Evidence could be given by an academic with limited practical training, by a retired practitioner who has not practised for many years, or indeed by anyone with a recognised general medical degree without regard to specialisation. The discretion exercised by judges in some recent Australian trials has resulted in decisions which have caused concern in the medical community. The following cases are illustrative. In Woods v. Lowns & ors,2 the issue was whether it was reasonable for the defendant paediatric neurologist not to have prescribed rectal diazepam for epilepsy in a child in 1987. The plaintiff's expert from the United Kingdom asserted that the omission to prescribe rectal diazepam fell short of the standard of good medical practice, although he was aware, and the court accepted, that it was universal practice of paediatric neurologists in Australia in 1987 not to prescribe this form of the drug. Although this expert was expressly criticised by the trial judge for acting as an advocate for the plaintiff rather than as an independent witness, his evidence might appear to have influenced the resulting judgment. Secondly, in Curtin v. Holliday & anor,3 a specialist oncologist gave evidence on the issue of early diagnosis of breast cancer by a general practitioner. The evidence of an expert in the advanced treatment of cancer is arguably irrelevant and perhaps unreliable in relation to the standard of practice applicable to a general practitioner. Thirdly, the evidence of a general surgeon on a renal physician's treatment of rhabdomyolysis was admitted by the judge in a jury trial,4 despite the surgeon's forced concession that he had never treated the condition, nor been involved in its management, and had not discussed such a condition at a scientific meeting. The general surgeon was arguably not qualified to provide the required evidence at issue. Governor Samuels' oration discusses reform initiatives on the use of expert evidence in the United States and their potential application in Australia. The US Supreme Court, in Daubert v. Merrell Dow Pharmaceuticals, considered the issue of scientific validity of expert testimony.5 The decision outlined indicators which would assist a court in determining scientific reliability: whether the assertion can be and has been tested; whether the theory or technique has been subjected to peer review and publication; and the known or potential rate of error. These indicators represent a move away from the pre-existing test (widely, but not universally, in use in the US), which refers to mere "general acceptance" within a relevant scientific community. While this US decision has no direct applicability in Australia, the test for reliability may be a useful model for procedural reform. Reforms have also been suggested in the UK, where Lord Woolf, Master of the Rolls, was appointed in 1994 to review the civil justice system in England and Wales. In his interim report, Lord Woolf recommended that the court should have "complete control" over the calling of expert evidence.6 This recommendation was reaffirmed, despite some opposition, in Lord Woolf's final report.7 In October 1996, the Chief Justice of the Federal Court of Australia, Michael Black, made some proposals regarding the use of expert evidence, and called for submissions from the Australian Law Council and other "professional bodies in the fields of economics, patents, trade marks, copyright, engineering and accounting".8 The Federal Court's initial proposal mirrored Lord Woolf's recommendation (above), but has since been amended to state that "the calling of expert evidence would usually be subject to the control of the parties, with the Court taking some control in exceptional cases".9 Other elements of the proposal included development of a code of conduct for experts, the requirement that expert evidence be addressed to the court, and the use of a panel of experts in a manner similar to that used with apparent success by the Australian Competition Tribunal. In this Tribunal, expert economists submit written statements before the oral proceedings. At the conclusion of all the evidence the experts give their opinions on the issues arising from the evidence and on the opinions of the other experts. They are entitled to modify their written views as much as they wish, so that the Tribunal can hear their present views after having access to all the evidence. In addition, the Australian Law Reform Commission is including the issue of expert evidence in its review of the adversarial system of litigation in federal courts and tribunals.10 The Australian and UK initiatives are aimed at modifying the role of experts in the adversarial arena, so that they can metaphorically wear their laboratory or clinical coats rather than advocates' robes. The initiatives are likely to encourage judges to be more active as assessors, and thereby to make the common law system less adversarial. Interestingly, provisions in the New South Wales Supreme Court Rules permit, but do not oblige, judges to appoint their own experts.11 In practice, these provisions have been rarely used, except in some patent cases. Other possible reforms to the laws on expert medical evidence could include: The addition of a reliability threshold test, such as that outlined in the US Daubert decision; The requirement that evidence of accepted practice or standard within a specialised area be given only by someone with qualification and currency of practice in that specialised area; The involvement of learned medical colleges in establishing panels of accredited experts to be available to litigants and the courts, and in formulating a code of conduct for expert witnesses; and The adoption of some of the better elements of the Roman inquisitorial process in relation to expert evidence, such as the use of court-appointed experts or expert assessors to sit with, and advise, the judge. The gap between medicine and the law is at its widest in the adversarial system of law. The proposals being considered by the Federal Court and the Australian Law Reform Commission should not be left entirely to the legal profession and the legislators, without input from other learned professions. Given the frequency of personal injury claims and the importance of medical expert evidence in these claims, the medical profession should take a significant role in the reform process. Richard T T Tjiong Chairman United Medical Protection, Sydney, NSW Samuels G. Medical truth and legal proof. Med J Aust 1998; 168: 84-87. Woods v. Lowns & ors. Unreported, NSW Supreme Court, No. 14529, 9 Feb 1995. Curtin v. Holliday & anor . Unreported, NSW Supreme Court, No. 20147/96, 19 Dec 1996. Ford v. Garrick , NSW Supreme Court, No. 15966/88, 1994. Daubert v. Merrell Dow Pharmaceuticals 113 Sct 2786 (1993). The Right Honourable the Lord Woolf. Access to justice: interim report to the Lord Chancellor on the civil justice system in England and Wales. London: HMSO, 1995: 192. The Right Honourable the Lord Woolf. Access to justice: final report to the Lord Chancellor on the civil justice system in England and Wales. London: HMSO, 1996: 139. Black CJ. Letter to the Australian Law Council, dated 24 October, 1996. Available from the Registrar, Federal Court of Australia, Sydney, NSW. Black CJ. Letter to the Australian Law Council, dated 20 August, 1997. Available from the Registrar, Federal Court of Australia, Sydney, NSW. Australian Law Reform Commission. Review of the adversarial system of litigation. Issues Paper 20. Canberra: AGPS, April 1997: 7.76-7.79. New South Wales Supreme Court Rules, Parts 39.2, 39.3. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Richard T Tjiong

Collateral damage from alcohol abuse: the enormous costs to Australia Curtailing the rippling effect of irresponsible drinking MJA 1998; 168: 6-7 Alcohol abuse is a problem that could affect any member of society, including the majority who are abstinent or use alcohol in moderation. Although much has been written about alcohol abuse and its effects on the drinker, there has been less emphasis on the deleterious effects on innocent bystanders, such as the physical, emotional and/or financial loss or damage. The spectrum of this "collateral damage" includes alcohol-related violence, road accidents, family problems, adverse pregnancy outcomes, consequences of alcohol abuse by doctors, and the resultant financial burdens incurred by society. Past studies have found that alcohol abuse plays a significant role in violent crime.1 It is estimated that about 13% of Australians aged 14 years and over (well over one million people) have been physically abused at least once by someone affected by alcohol, while 16% have had their property damaged at least once.2 Alcohol has also been implicated in about one-third of sexual assault cases.3 In 1992, 294 people died from alcohol-related assaults in Australia.1 Drunk drivers put not only their own lives in peril, but also pose a significant risk to other road users. In NSW in 1995, of the 620 people killed in road accidents, 141 (including 37 passengers and pedestrians) died in alcohol-related accidents. In addition, 298 non-drivers were seriously injured.4 Even more dramatic examples of alcohol-related transport accidents have been recorded internationally, such as the tragic Exxon Valdez oil spill in Alaska in 1989. At least 1% of the population (about 180 000 people) have a close family member with a serious alcohol problem. Isolation, neglect, aggression and disruption within the family, particularly spouse abuse, are frequent.5 Sexual and financial problems, stress, verbal and physical abuse, separations and divorce are also common between couples where at least one partner abuses alcohol.6 A Victorian report in 1988 found that alcohol was definitely or possibly involved in 53% of several thousand reported incidents of family violence.7 Children are particularly affected by having an alcoholic parent and they are more likely to become depressed,5 have lower IQ,8 and be alcohol dependent themselves in the future.9 In 1992, there were 226 hospital episodes resulting from alcohol-related child abuse in Australia.1 However, the extent of family problems is probably underestimated because there is underreporting of alcohol-related domestic violence. Maternal alcohol abuse is associated with adverse perinatal outcomes. These include the fetal alcohol syndrome, pseudo-Cushing's syndrome, alcohol withdrawal in the newborn, and increased risk of perinatal mortality.10 The incidence of fetal alcohol syndrome has been estimated to be between one and two per thousand live births, or 250 to 500 new cases per year in Australia.11 Alcohol abuse among doctors may lead to impaired clinical judgement and skills. While it is widely believed that alcohol abuse may be common among medical professionals, it is very difficult to identify doctors with alcohol-related problems. In the 12 months to March 1996, the NSW Medical Board heard 31 matters related to "impaired registrants", of which five were related to alcohol abuse.12 Similar problems may also occur in other health care workers. The costs of this to society include the costs of litigation, as well as the costs of patients' excess morbidity and mortality. The financial burden of alcohol abuse to the Australian community is substantial. In 1992, the costs of alcohol abuse were estimated to be $4.5 billion, or $250 for every man, woman and child in Australia.13 About three-quarters of these costs were tangible, including lower productivity because of lost work days, health care costs, road accident costs and legal and court costs. About 93% of the total tangible costs were borne by business and government. The intangible costs of about $1 billion include the value of loss of life, and pain and suffering of road accident victims.13 The extent of the problems and costs of alcohol abuse is enormous, but they can be reduced or prevented. About 84% of the costs ($3.8 billion) have been deemed avoidable and potentially amenable to public policy initiatives and behaviour changes.13 While health interventions may play a role, by detection and treatment of alcohol misuse, tougher measures need to be taken in other areas to prevent hazardous drinkers from doing harm to themselves and also to others. Such measures might include: alcohol taxation to reflect alcohol content of beverages rather than the cost of manufacture; major aim of liquor law reforms to be reduction of alcohol-related harm; strict enforcement of liquor laws by both police and state licensing authorities; mandatory training in liquor laws of bar staff, managers and licensees; and a truly independent alcohol advertising regulation authority. The NSW Parliament has enacted legislation which requires hotels, clubs and restaurants not to serve alcohol to patrons with certain defined behaviour suggesting intoxication (Liquor and Registered Clubs (Harm Minimisation) Act (NSW) 1997). The fines for drunken patrons who refuse to leave entertainment premises, if requested to do so, have been increased from $2000 to $5000. These measures are a necessary, but only preliminary, step to place the onus of responsibility on alcohol abusers for their actions, to encourage retailers to adopt a strict code of conduct and to protect the public from the consequences of irresponsible drinking. Yen F Tai Medical Student, University of Sydney, NSW John B Saunders Head, Department of Alcohol and Drug Studies University of Queensland, Brisbane, QLD David S Celermajer Associate Professor of Medicine, University of Sydney, NSW English DR, Holman CDJ, Milne E, et al. The quantification of drug caused morbidity and mortality in Australia. Canberra: Commonwealth Department of Human Services and Health, 1995. National Campaign Against Drug Abuse. National Household Drug Survey report. Canberra: AGPS, 1993: 2. Victorian Community Against Violence. A profile of rapes reported to police in Victoria 1987-1990. Melbourne, 1991. Roads and Traffic Authority, New South Wales. Road traffic accidents in NSW -- 1995. Sydney: Roads and Traffic Authority, 1996: 84-86. Orford J. Family coping. In: Proceedings of the International Congress on Alcohol, Other Drugs and the Family; 1988 November 27-30; Sydney: Alcohol and Drug Foundation, 1989: 30-35. Straussner SLA. The impact of alcohol and other drug abuse on the American family. Drug Alcohol Rev 1994; 13: 393-399. Law Reform Commission of Victoria. Homicide. Report No. 40. Melbourne: The Commission. 1991: 149. Ervin C, Little R, Streissguth A, Beck D. Alcoholic fathering and its relation to child's intellectual development: A pilot investigation. Alcohol Clin Exp Res 1984; 8: 362-365. McCaul ME, Turkkan JS, Svikis DS, et al. Alcohol and drug use by college males as a function of family alcoholism history. Alcohol Clin Exp Res 1990; 14: 467-471. Rankin JG, Ashley MJ. Alcohol-related health problems. In: Last J, Wallace R, editors. Public health and preventive medicine. 13th ed. Connecticut: Appleton-Lange, 1992: 741-767. Abel EL, Sokol RJ. Incidence of fetal alcohol syndrome and economic impact of FAS related anomalies. Drug Alcohol Depend 1987; 19: 51-70. New South Wales Medical Board. Annual report for the period ending 31 March 1996. Sydney: The New South Wales Medical Board, 1996. Collins DJ, Lapsley HM. The social costs of drug abuse in Australia in 1988 and 1992. National drug strategy monograph series No. 30. Canberra: Commonwealth Department of Human Services and Health, 1996. ©MJA 1997 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Yen F Tai · John B Saunders · David S Celermajer

Long-term ventilatory support at home: any progress? Is breathing at home a right or a privilege? MJA 1998; 168: 7-8 Since Newton-John's 1989 editorial in the MJA calling for better support for patients needing long-term mechanical ventilation,1 there has been little progress nationally. However, a start has been made in Victoria with the establishment of the Victorian Respiratory Support Service. It seems self evident that home rather than institutional care is desirable for these patients -- in this age, it is not only Superman,2 but Everyman, who should be able to live at home on a ventilator. However, home care is possible only when the financial costs and caregiver needs can be adequately met, which depends primarily on patients' personal resources and access to government-funded programs. Access to community programs such as the joint federal- and state-funded Linkages program, which provides for up to 32 hours of attendant care per week, is severely restricted, with waiting lists in many areas. In addition, this level of care may be inadequate to meet the needs of severely disabled people. The cost of ventilators is met by the federally funded Program of Aids for Disabled People in New South Wales, but not in Victoria, where it is met by a specific program grant. Further, for patients who need discontinuous (e.g., nocturnal) ventilation, the cost of acute hospital care to introduce the treatment is not adequately addressed under casemix funding. Chronic ventilator dependence has been defined as use of mechanical ventilation for at least six hours daily for at least 21 days.3 In the past, patients who were ventilator dependent for part or all of the day comprised mainly those who failed to wean after bouts of acute respiratory failure (e.g., post-poliomyelitis),4 and a cumbersome negative-pressure "iron lung" ventilator was used. Recent technological advances, particularly development of small portable ventilators and face and nose masks that allow non-invasive, intermittent positive-pressure ventilation, have made mechanical ventilation practical in a wider range of patients. It can improve quality and duration of life in patients with chronic hypercapneic ventilatory failure caused by restrictive chest-wall disease, spinal cord injury, slowly progressive neuromuscular disease, central hypoventilation or obesity-hypoventilation syndrome.5 The awareness that ventilation is effective treatment for a wider range of indications has led to a rapid increase in the number of ventilator-assisted individuals in Australia and other countries. The Victorian Respiratory Support Service, based at Austin and Repatriation Medical Centre, now provides care for over 170 people, an increase from 25 in 1989. Their underlying diagnoses are shown in the Box (below); 15 receive continuous ventilatory support via tracheostomy, five use a negative-pressure ventilator (iron lung) at night, and the remainder use non-invasive positive pressure ventilation via nasal mask. New patients also tend to have more complex needs. For example, of the 40 new patients started on ventilatory support in the six months to January 1997, eight (20%) required a tracheostomy, including five (13%) receiving continuous ventilatory support. Nationally, the National Health and Medical Research Council (NHMRC) identified 19 children and 39 young adults receiving home ventilation in 1993, including six with a tracheostomy.6 In the absence of a national register, it seems likely that there are more than 500 adult ventilator-assisted individuals at present, 95% of whom live at home (Associate Professor Ron Grunstein, Senior Staff Specialist, Centre for Respiratory Failure and Sleep Disorders, Royal Prince Alfred Hospital, Sydney, NSW, personal communication). The proportion of ventilator-assisted individuals cared for at home varies between countries, largely depending on the support available and types of patients undergoing ventilation. In Japan, a national survey of long-term ventilator-assisted children in 1993 found that only 61 (14%) of 434 patients aged under 20 years were ventilated at home, largely because there was no system in place to support their care at home.7 In the United States, Medicaid reimbursement in 1990 was estimated to cover only 46% of the costs of care of the approximately 11 000 chronic ventilator-dependent patients.4 Patient discharge from acute care facilities to home was often delayed by a lack of community resources, and to long term care facilities by a shortage of beds.4 In 1990, this delay was estimated to average 35 days, adding US$27 000 per patient to the cost of acute care.4 In Minnesota, the proportion of ventilator-assisted individuals cared for at home decreased from 81% to 65% between 1986 and 1992, while total numbers increased by 110%.8 Studies of the long term outcomes of home mechanical ventilation and the factors that influence these are limited. However, a case-control study from Papworth Hospital in the United Kingdom showed that patients managed in a specialised weaning centre had a higher rate of survival to discharge from hospital than control subjects receiving conventional management (94% versus 59%) and a three-year survival rate (63.5%) similar to the one-year survival rate for control subjects.9 In France, which has a national program responsible for nearly all ventilator-dependent patients and for 70% of those receiving home oxygen therapy, a survey of ventilator-assisted individuals found mean survival for those with a neuromuscular disease and kyphoscoliosis was 6.5 and 8 years, respectively.10 We believe that initial care for patients who become ventilator dependent should be provided in designated acute care hospitals by specialised units with expertise in their management. Such units can undertake weaning from continuous ventilatory support and/or initiation of nocturnal ventilatory support with a multidisciplinary team approach that focuses on pulmonary and general rehabilitation. Although current casemix formulas include categories for patients requiring continuous ventilatory support, they fail to address adequately the acute hospital costs of those requiring discontinuous support, which vary widely depending on the complexity of care needed. For non-invasive ventilation, initial cost for the ventilator varies between $4500 and $17000, and annual costs for consumables vary between $200 and $3800. Equipment maintenance can exceed $1000 a year, and enteral feeding, if required, can also add up to $4500 a year. For tracheostomy patients, initial costs may be up to $6500 higher and consumables may add another $2400 a year. Ultimately, home rather than institutional care is desirable for ventilator-assisted individuals, but can be considered only when the financial and caregiver needs can be met. When home care is not feasible, supported accommodation must be found in the community. We believe that, ideally, payment for the care of ventilator-assisted individuals after discharge from an acute care hospital should be provided under a program grant that: recognises the need for case management, training of carers, provision of respite and residential care, along with attendant care if required, while recognising that ventilator-assisted individuals have a major role to play in their own case management; provides funding for ventilators and consumables; provides an administrative and clinical supervisory mechanism to ensure accountability; provides funding for core staff, including a respiratory nurse, physician, respiratory physiotherapist and a care coordinator in each State to provide appropriate training for carers (professional and non-professional) of ventilator-assisted individuals in the community; and provides additional funding for ventilator-assisted individuals who require supported residential care in the community, as the new Commonwealth classification of nursing home and hostel residents which came into effect on 1 October 1997 is unlikely to fund their care adequately. There is an urgent need to monitor the characteristics of ventilator-assisted patients and to evaluate treatment outcomes so that policies and programs can be developed to provide effective support services. A national approach is needed, with an NHMRC report on home ventilation for adults as a necesary first step towards identifying the needs of this neglected but growing group. Donald A Campbell Senior Specialist Robert J Pierce Director, Department of Respiratory Medicine Austin and Repatriation Medical Centre, Melbourne, VIC Newton-John HF. Long term mechanical ventilation of patients in Australia. Med J Aust 1989; 150: 3-6. Rosenblatt R. New hopes, new dreams. Time 1996; 26 Aug: 57-68. Health Care Financing Administration. Chronic ventilator-demonstration: technical advisory panel. Washington, DC (USA): HCFA, 1990. Hill NS. Failure to wean: the chronic ventilator-dependent patient. In: Fishman AP, editor. Pulmonary rehabilitation. New York: Marcel Dekker Inc, 1996: 577-617. Make BJ, Gilmartin ME. Care of ventilator-assisted individuals in the home and in alternative community sites. In: Hodgkin JE, Connors GL, Bell CW, editors. Pulmonary rehabilitation: guidelines to success. 2nd edition. Boston: J B Lippincott, 1984: 359-391. Report of the National Health and Medical Research Council Healthcare Committee Expert Panel on Home Mechanical Ventilation for Children and Young Adults. Canberra: AGPS, 1994. Sakakihara Y, Yamanaka T, Kaji M, Kamoshita S. Long term ventilator-assisted children in Japan: a national survey. Acta Paediatr Jpn 1996; 38: 137-142. Adams AB, Whitman J, Marcy T. Surveys of long-term ventilatory support in Minnesota: 1986 and 1992. Chest 1993; 103: 1463-1469. Smith IE, Schneerson J. A progressive care program for prolonged ventilatory failure: outcomes, February 1992 to November 1996. Proceedings of the Sixth International Conference on Home Mechanical Ventilation. 1997 Mar 5-7; Lyon, France. Lyons: Service de Reanimation Medicale et d'Assistance Respiratoire. Hopital de la Croix-Rousse, 1997: 51. Chailleux E, Fauroux B, Binet B, et al. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation: a ten year analysis of ANTADIR observatory. Chest 1996; 109: 741-749. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Donald A Campbell · Robert J Pierce

MJA: Guest - Special pleading at Kyoto Special pleading at Kyoto Australia's economic argument on greenhouse gases is a health hazard MJA 1997; 167: 567-568 Global climate change reflects the major social and economic issues of our time. Poverty, population growth, unequal consumption of resources, energy production, the growth of cities and industries, and agricultural and food practices all now affect global ecology, and ecological changes, including the influences of greenhouse gas emissions on climate, will have adverse effects on the health of human beings.1,2 As major advisers on health matters, medical professionals should stay informed about the status of current negotiations in Kyoto about reducing greenhouse gas emissions. Australia was one of the first countries to ratify the Framework Convention on Climate Change in 1992, adopted at the Earth Summit in Rio de Janeiro.3 Only general principles were agreed, leaving specific targets for reduction of greenhouse gas emissions to be negotiated at future meetings of the treaty parties. The Australian Government has threatened to walk away from negotiations to set binding uniform emissions targets in Kyoto this month,4 arguing that Australia's economic interest in protecting our fossil fuel industry requires a policy of "differentiation" or non-uniform targets. While the Australian Government notes "that the balance of evidence suggests a discernible human influence on global climate",5 thus accepting that there is a problem, its solution remains a matter of international disagreement. According to our Ministry for the Environment, "differentiation" is intended to produce a "fair, achievable and therefore environmentally effective outcome. Uniform targets [for limits to greenhouse gas emissions] are flawed because they are unrealistic and impose different economic costs".6 It is possible that a form of "differentiation" could be equitable. Indeed, the 1992 climate change convention itself raises the possibility of different targets for developed and developing countries. The problem with the Australian position is its narrow focus on economic considerations. The Government has sought a balance between the threat of climate change and "the significant economic costs that will affect some countries far more than others". 6 Australia's arguments have alienated the United States, the European Union and Japan. More importantly, this stance downplays the threat to life on this planet. Although much of the pollution that has contributed to global climate change has been produced by developed countries, it is likely that the worst consequences will be felt by Third World nations and by future generations. The lack of resources to stem flooding and to adapt agricultural practices to climate change will increase the human vulnera bility that accompanies the exponential growth of poorly housed populations with inadequate infrastructure for health services. International cooperation will be needed to understand and prevent adverse health effects of global climate change, such as increased morbidity and mortality from a greater frequency of heatwaves and drought, and changes in the distribution, incidence and severity of vectorborne diseases.1,2,7 The role of public health research in this area is to provide forecasts of major consequences to inform pre-emptive policymaking.8 In our region, studies of climate-related arboviral diseases are under way,9 and projections of the numbers of heat-related deaths expected with global warming in Australian coastal cities are available.10 However, a health-based argument cannot and should not rest on local data. It is concern for human health worldwide, with the possibility of problems escalating over coming decades, that justifies setting serious greenhouse gas emission targets in Kyoto. The optimism that followed the Earth Summit in Rio de Janeiro in 1992 has degenerated into a "babble of diplomatic doubletalk".11 The effort of the fossil fuel industry and other lobby groups to delay the setting of mandatory emission targets for developed countries beyond 2000 has been a perverse success. The climate change convention can only become effective at Kyoto if wealthy nations like Australia are active partners to any agreement reached. We need global action. The Canadian Medical Association has called on its federal government to reaffirm a position for achieving reductions in greenhouse gas emissions (Emeritus Professor John Last, University of Ottawa, personal communication). The Australian Medical Association could follow this example, thus adding to its significant role in the debate about global environmental matters in recent years.12,13 The (American) Institute of Medicine identifies three requirements for promoting participation in international health matters by developed nations, namely "protecting our people, enhancing our economy and advancing our international interests".14 However, unless more countries can meet those aims simultaneously, we are all likely to be losers in the climate change stakes.15 In the game of global sustainability, all nations are ultimately on the same side. In considering long-term policies across government sectors that will affect climate and health, we have to face the reality of "our common future", which for some has become merely a clichŽ.16 The Australian Government's position on "differentiation" arises from its wish to pay less for contributing to pollution, and from ignoring the "polluter pays" principle. "Differentiation" on economic grounds, as Australia would have it, may imply that countries with the highest emissions would be required to do the least to reduce them, while countries that have already done most to reduce their emissions could be required to do more.4 Regardless of whether the Australian Government's approach survives at Kyoto in the present state of uncertainty about the effects of climate change, the "precautionary principle" should apply. In the context of environmental conservation, the precautionary principle recognises the existence of uncertainty and ignorance, accepts that uncertainty should not be used as an excuse for doing nothing, and shifts the onus of proof away from opponents to proponents, who must demonstrate that, to a very high degree of probability, a project will not cause significant harm to the environment.17 Anticipatory and preventive actions are also central to this principle. Precautionary measures aimed at reducing greenhouse warming would soon demonstrate benefits for public health. For example, reduced use of private motor vehicles would bring immediate health gains (such as reduced air pollution and increased fitness). In turn, less air pollution would reduce health hazards from inadequate water quality (acid precipitation).1 It is also possible that economic benefits would accompany increased efficiency of energy consumption, an area that needs research and development.18 Concentrating on the economy without ensuring the health of human populations does not make sense. Rather than taking a narrow, short term view of national self-interest, Australia should play a major part in international agreements and action to abate greenhouse gas emissions. Adaptation, or learning to live with climate change in the future, must not be considered an alternative to reducing the causes now. Charles Guest Senior Fellow, National Centre for Epidemiology and Population Health Australian National University, Canberra, ACT McMichael AJ, Haines A, Slooff R, Kovats S, editors. Climate change and human health: An assessment prepared by a Task Group on behalf of the World Health Organization, the World Meteorological Organization and the United Nations Environment Programme. Geneva: World Health Organization, 1996. Jackson EK, Guest CS, Woodward AJ. Climate, health and medicine in a changing world. Med J Aust 1996; 165: 597-598. Taplin R. Greenhouse: an overview of Australian policy and practice. Aust J Environmental Management 1994; 1: 142-155. Hamilton C. Climate change policies in Australia. Canberra: The Australia Institute, 1997: 3. Office of the Minister for the Environment. The global warming challenge: Australia. Canberra, Parliament House, July 1997. Hill, Senator The Hon. R. The greenhouse challenge -- its role in addressing climate change issues. Address to Minerals Council Conference, Adelaide. 13 October 1997. McMichael AJ, Haines A. Global climate change: the potential impacts on human health. BMJ 1997; 315: 805-809. Haines A, McMichael AJ. Climate change and health: implications for research monitoring and policy. BMJ 1997; 870-874. Lindsay M, Mackenzie J. Vector-borne viral diseases and climate change in the Australasian region: major concerns and the public health response. In: Curson P, Guest C, Jackson E, editors. Climate change and human health in the Asia-Pacific region. Canberra: Australian Medical Association. In press. Guest CS. Climate change and human health: global and regional perspectives. In: National Academies' Forum (Farquhar G, chair). Australians and our changing climate. Canberra: Australian Academy of Science, 1997: 48-50. Gelbspan R. The heat is on. The high stakes battle over earth's threatened climate. Reading, Mass.: Addison-Wesley, 1997: 112. Arnold P, editor. Our health -- our environment: a national stocktake. Canberra: Australian Medical Association, 1995. Weedon D, on behalf of the Australian Medical Association. Climate change: a perspective from the medical community. Submission to the 1996 Major Review of the Greenhouse Response Strategy. Canberra: Australian Medical Association, 1996. Institute of Medicine. America's vital interest in global health. Washington: National Academy Press, 1997. Woodward A. Climate change and human health: the vulnerability of the Asia-Pacific. In: Curson P, Guest C, Jackson E, editors. Climate change and human health in the Asia-Pacific region. Canberra: Australian Medical Association. In press. McMichael AJ, Hales S. Global health promotion: looking back to the future. Aust N Z J Public Health 1997; 21: 425-428. Diesendorf M. Principles of ecological sustainability. In: Diesendorf M, Hamilton C, editors. Human ecology, human economy. St Leonards: Allen & Unwin, 1997: 64-97. Wilkenfeld G. Greenhouse gas emissions from the Australian energy system: the impact of energy efficiency and substitution. Canberra: Report to the Energy Research and Development Corporation, 1991. - ©MJA 1997 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Charles Guest

Cloning: potential benefits for human medicine Of babies, lambs, medicine and milk MJA 1997; 167: 568-569 Recent developments in cloning of animal cells (such as the creation of the lamb "Dolly")1,2 and the consequent ban by President Clinton on cloning humans in the United States3 have stimulated much discussion of the merits and ethics of cloning. Indeed, a number of countries (e.g., Germany and Denmark) and Australian States (e.g., Victoria) ban all forms of cloning in human reproductive medicine by legislation or regulation. The most publicised advance in cloning attended the birth of Dolly, a lamb created from a ewe's mammary cell.2 This achievement showed that completely differentiated cells (both fetal and adult) may be reprogrammed to return to multipotential embryonic cells. This is done by inducing a quiescent state (G 0 phase of the cell cycle) in the somatic cell and then fusing it with the enucleated cytoplasm of a mature egg (Figure 1). The fused product then acts as an embryo and develops according to a preset maternal program rather than as the original somatic cell. At present, the procedure is relatively inefficient and confined to ruminant species (sheep and cattle).1,2,4,5 It is unsuccessful in rodents,6,7 which have been the model for understanding mammalian cell differentiation and tissue formation. It is not known if humans fit the ruminant or rodent model, although the recent births of rhesus monkeys derived from embryonic cells (Dr D Wolf, Senior Research Scientist, Oregon Regional Primate Research Center, Beaverton, Oregon, US, personal communication) suggest the former. This finding has major implications for medicine and agriculture, as it opens the way to use differentiated somatic cells as vectors for genetic engineering to produce transgenic animals and for gene therapy. Considerable research on developing such vectors has focused on embryonic stem (ES) cells. Rodent ES cells have been widely used for determining gene function, as they can be manipulated to "knock out" or upregulate genes or to introduce foreign genes.8 ES cells combined with early embryos contribute to all body tissues during development, including gonadal germ cells. When bred, the resulting animals transmit the ES cell genotype, allowing the effects of the gene manipulations to be analysed. It would be even more efficient to genetically manipulate somatic cells of sheep or cattle in culture and to use these cells for cloning 2 (Figure 2). Offspring would probably always have the desired transgene. This could code for a human protein used to treat or prevent disease (such as factor VIII and interferon), and large quantities of the protein could be produced in the animal's milk under the control of specific promoters. As proteins can be isolated from milk relatively simply, this might be an extremely cheap and efficient way to produce large quantities of human or animal pharmaceuticals. It might also be very competitive with present methods of producing recombinant proteins (e.g., from bacterial, yeast and mammalian cell lines). When one considers the cost and problems of producing antiviral drugs as well as proteins for immunisation and therapy (e.g., for haemophilia, HIV infection and multiple sclerosis), the potential for pharmaceutical production in cattle becomes economically attractive. Australia has a unique position for developing this biotechnology as our sheep and cattle are relatively disease-free. What might be other benefits of the recent advances? The search for human multipotential cells as vectors for gene therapy and as universal transplantation cells for correcting abnormal tissue function or tissue damage in humans has also focused on ES cells. 9 These have been derived from the embryonic inner cell mass,10 undifferentiated gonadal cells (GS cells),11 and stem cells which form specific tissues.12 Progress on producing these cells has been limited, although a rhesus monkey ES cell line was recently produced.13 However, ES cells may still be recognised as foreign and be rejected by the recipient. Cloning a patient's somatic cells could be a way of producing multipotential cells that are genetically identical to those of the patient and therefore not subject to rejection (Figure 3). These cells might be ideal vectors for gene therapy, but would also need to be clonally stable and to produce the cell type needed for transplantation, which requires considerable further research. These potential benefits of cloning are often ignored in the debate about its use for human reproduction. Yet, cloning could not reproduce an individual with the same attitudes, beliefs and behaviour as the original person because of the predominant influence of non-genetic factors in human development.14 While no real objection is raised to identical twins produced by natural conception, or even as a result of in-vitro fertilisation, cloning of individuals from somatic cells has no biological or social merit and in this context is unethical. However, we should not lose the substantial benefits of other applications of cloning technology in the regulatory and legislative processes, and moratoriums should not impede progress to achieve these benefits. Alan O Trounson Professor, Institute of Reproduction and Development, Monash University Monash Medical Centre, Melbourne, Victoria Campbell NHS, McWhir J, Richie WA, et al. Sheep cloned by nuclear transfer from a cultured cell line. Nature 1996; 380: 64-66. Wilmut I, Schnieke AE, McWhir J, et al. Viable offspring derived from fetal and adult mammalian cells. Nature 1997; 385: 810-813. Gorman C. To ban or not to ban? Time 1997; June 16: 66. Willadsen SM. Nuclear transplantation in sheep embryos. Nature 1986; 320: 63-65. Tatham BG, Dowsing AT, Trounson AO. Enucleation by centrifugation of in vitro matured bovine oocytes for use in nuclear transfer. Biol Reprod 1995; 53: 1088-1094. Surani MAH, Barton SC, Norris ML. Experimental reconstruction of mouse eggs and embryos: an analysis of mammalian development. Biol Reprod 1987; 36: 1-16. McGrath J, Solter D. Nuclear transplantation in the mouse by microsurgery and cell fusion. Science 1983; 220: 1300-1302. Joyner A. Gene targeting and gene trap screens using embryonic stem cells: new approaches to mammalian development. Bioessays 1991; 13: 649-656. Trounson A. Research on the development of human embryonic stem cells. Sing J Obstet Gynaecol 1994; 25: 245. Pedersen RA. Studies on in vitro differentiation with embryonic stem cells. Reprod Fertil Develop 1994; 6: 543-552. Travis J. Human embryonic stem cells found? Science News 1997; 152: 36. PrŸmmer O, Fliedner TM. The fetal liver as an alternative stem cell source for hemolymphopoietic reconstitution. Int J Cell Cloning 1986; 4: 237-249. Thompson JA, Kalishman J, Golos TG, et al. Isolation of a primate embryonic stem cell line. Proc Natl Acad Sci USA 1995; 92: 7844-7848. Machin GA. Some causes of genotypic and phenotypic discordance in monozygotic twin pairs. Am J Med Genet 1996; 61: 216-228. Reprints: Professor A O Trounson, Institute of Reproduction and Development, Level 5, 246 Clayton Road, Clayton, VIC 3168. - ©MJA 1997 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Alan O Trounson

Medicine, modernism and after: a new role model for the doctor? "Everyone has something to contribute to the truth . . ." Aristotle 1 MJA 1997; 167: 570-571 Mainstream philosophy, which is characterised by the philosophical ideas of the Enlightenment, has been strongly criticised in the past 30 years or so for being too "rational" and too "empirical". Its critics have insisted that the basis for knowledge is much less secure than these schools of philosophy, which include logical positivism and scientific realism, would have us believe.2 Side by side with this critique, there has developed a critique of the North-West European (specifically, Scandinavian) Welfare State, which has been called a modernist attempt to achieve the "good life" or a "good society" by rational, empirical means, such as equal distribution of goods meeting "basic human needs". The Welfare State has been characterised as the welfare expression of one kind of economic rationalism. The most radical of "postmodern" critics, however, claim that the rationalist project has failed. We cannot even define things like "truth", let alone legislate to achieve "the good", says this line of argument: everything has to be determined by discourse among local communities; it is up to the individual citizen to decide how to live his or her life; one claim is as good as another -- relativism rules. This negative critique has been directed at the State in general, under the ideological motto "Less State, more community". Combatants in politics and political philosophy should learn, however, from combatants in branches of philosophy, particularly the philosophy of science. They have had to learn the dangers of throwing out the baby with the bath water. Thus, it has not been possible to jettison concepts of truth and rationality, but it has been necessary to repolish them and repair the damage done by the critiques.3 It is true that the institutions of the Welfare State have become paternalistic, have suppressed the autonomy of citizens and neglected the diversity of perspectives and values within pluralistic societies. There is no doubt that all this should be opposed. But there is little reason to think that nations will benefit from dismantling State institutions, and replacing them with entrepreneurial services operating within the marketplace. What is needed instead is a radical understanding and disclosure of the mechanisms which have sometimes made the State a controller rather than a system promoting human well-being.4-6 Instead, critics have claimed that a dangerous symbiosis has developed between paternalistic welfare systems and irresponsible citizens, who perceive opportunities to accumulate wealth by exploiting the system. There is, however, absolutely no reason to believe that a politics which defends the rights of citizens and which provides necessary services should in any way undermine human autonomy. Equally, there is no reason to believe that people living in local communities without State interference would be any more responsible than citizens in a State devoted to providing security and opportunities. The "Less State, more community" catchcry assumes that the Welfare State has systematically corrupted its citizens. There is little evidence to support this claim. The German philosopher Hegel argued that there were strong reasons to believe that the activities of the State were perfectly compatible with the development of autonomy, 7 and there is no reason to doubt that he was right. Hegel claimed that the modern idea of the self-conscious individual, with ideas of freedom and autonomy, is based on the presupposition of a social structure, with institutions that included social and public services. To put this in a European context: what makes a Danish citizen a Dane is his or her being part of a society where institutions of social justice have been created, in which it would not in principle be accepted that any individual in that society should fall by the wayside, and that everything possible should be done to allow individuals and groups to flourish. It is not the citizenry that is in decline. The decline is in politics and politicians. It is the gradual destruction of the political institutions built over the past century or so that undermines individual autonomy and social cohesion, and diminishes the notion of social justice. Has medicine a part to play in reconstructing the performance of the body politic and a respect for politicians? To begin, it might need to broaden its view of its knowledge base, taking a more generous view of the truths that come to it from outside its very reductionist science. Its concern with human welfare would then start to look rather like the avowed concerns of the Welfare State. However, there may be a more direct role for medicine. From at least the time of Aristotle, Western medicine has inherited the idea of an analogy between medicine and politics. Both have practical goals: medicine, the health of the patient; politics, the conditions for human security and well- being. They are both (or should be) responsive to the individual. In medicine, there is a perceived inequality of power between the doctor as expert and the patient as supplicant. The person of practical wisdom (the ideal politician), on the other hand, "engages you actively in the 'treatment', taking your view of things as seriously as his own; he leads you on through the interchange of calm and clarifying argument to what he hopes will be an articulated picture of the good".8 In an age when politicians and planners often do not live up to this model, medicine might try to realise an even closer analogy between the doctor and the person of practical wisdom than Aristotle thought possible. Medicine might play a role in redeveloping the Welfare State as a system realising the Aristotelian ideal that "everyone has something to contribute to the truth . . .".1 We are left with two final questions, which are also challenges. Do doctors in general have the capabilities needed to act according to this ideal of practical wisdom? And, if not, how should medical education be changed to legitimate and encourage these capabilities? Uffe Juul Jensen Professor, Department of Philosophy University of Århus, Århus, Denmark Aristotle. The ethics of Aristotle: the Nichomachean ethics. London: Penguin, 1976. Rorty R. Philosophy and the mirror of nature. Princeton, NJ: Princeton University Press, 1979. Putnam H. Reason, truth and history. Cambridge: Cambridge University Press, 1980. Jensen UJ. Practice and progress -- a theory for the modern healthcare system. London: Blackwell Scientific Publications, 1987. Jensen UJ, Mooney G. Changing values: autonomy and paternalism in medicine and health care. In: Jensen UJ, Mooney G, editors. Changing values in medical and health care decision making. New York: John Wiley and Sons, 1991: 1-15. Jensen UJ. The year 2017: a revolution for democracy? The future of general practice in Europe. Copenhagen: European Union of General Practitioners, 1992: 18-24. Hegel G. The philosophy of right. Oxford: Oxford University Press, 1952. Nussbaum MC. The therapy of desire -- theory and practice in the Hellenistic era. Princeton, NJ: Princeton University Press, 1996. - ©MJA 1997 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Medical information and the World Wide Web Separating the signal from the noise MJA 1997; 167: 571-572 Ideally, the practice of medicine in Australia should combine the best of scientific medicine and the traditions of Sir William Osler, the pre-eminent physician of the turn of the century. The art of Osler's medical practice was to foster a personal relationship based on trust and confidence and make this relationship intrinsic to the therapeutic process.1Before the explosion of biomedical knowledge and technology, the communication of clinical information was not central to this patient-doctor relationship. The generation whose expectations were shaped by the Depression and World War II tended to respect the medical system and to follow doctors' orders without actively pursuing or questioning health matters.2 In stark contrast is the unquenchable thirst of the "baby boomers" for medical information. Their assertive consumerism and aggressive pursuit of information and choice2 has been accompanied by an explosion of mass media medical information. With this societal paradigm shift, the provision of clinical information is now integral to building trust and confidence in the patient-doctor relationship; in fact, the Consumer Health Forum of Australia recently reported that "consumers want communication by medical and hospital staff to enable patients, patients' families and carers to be better informed", and that "up to date information is essential to ensure that informed decision making processes are in place".3 Thus, the provision of reliable and relevant information has become a primary component of quality health care.4 There is no doubt that the Internet, particularly the World Wide Web (WWW), represents one of the most powerful vehicles yet created for disseminating such information.5 The opportunities for rapid communication and education are clear, and access to health care information on the Web should be of major benefit to both consumers and providers of health care. In June of this year, the United States National Library of Medicine, part of the National Institutes of Health (Bethesda, Maryland), inaugurated a program of free access for all Americans to MEDLINE -- the world's most extensive collection of published medical information -- on the Web.6 Announcing the service, the United States Secretary for Health and Human Services, Donna Shalala, said: "American citizens now have at their fingertips both the scientific information gathered by the National Library of Medicine as represented by MEDLINE and the extensive consumer information on Healthfinder.7 We are committed to using the new technology including the WWW and the Internet to provide health information to the public."8 However, the Web, despite its promise to deliver medical information and the presence of high quality medical resources (including medical journals such as The Medical Journal of Australia 9 ), is ruled by anarchy and information bedlam prevails. Anybody with a computer and Internet connection can be an author, editor and publisher rolled into one, and can do so anonymously. There is no accountability for the quality and safety of information. Impicciatore et al. recently surveyed the accuracy of medical advice management of fever in children on the Web.10 The keywords "fever management", "child" and "parent information" retrieved 41 Web pages, 32 produced by commercial ventures and nine by individual practitioners, clinics, academic institutions or other educational organisations. Only four of these pages adhered closely to the main recommendations of conventionally published guidelines. The authors of the report suggested there was an urgent need to check public-oriented health care information on the Internet for accuracy, completeness and consistency.10 This should not be terribly surprising. After all, those with medicopolitical or commercial agendas have the same access to the Web as those seeking to publish science. The activities of the former are illustrated by the unreferenced claims and rhetoric of pressure groups11 as well as the growing number of dubious or even preposterous health claims on the Web (e.g., shark cartilage has been "shown to be effective in inhibiting tumour growth and cancer; helpful in the treatment of arthritic conditions, macular degeneration, psoriasis and cartilage support"; and melatonin "strengthens the immune system, and reduces free radicals in the body"12 ). The simple search words "alternative medicine" open a virtual bazaar in the US, offering a wide variety of substances to treat any ailment.12 Despite the glitter and buzz of the technology, publishing medical information on the Web still relies on content; Silberg and colleagues argued recently that the quality criteria applied to medical information in print should be applied equally in the electronic world.13 The International Committee of Medical Journal Editors has agreed on a minimum set of benchmarks for medical information posted on the Internet (Box). Others have outlined criteria useful for evaluating Web pages and ways of measuring their impact.13,15 Criteria include: Credibility and conflict of interest (owner or sponsor of site; author credentials); and Structure and content of site (reference to sources; scope, accuracy and currency of content; readability; quality of links to other sites; media used to communicate material; function and impact of site). There is no reason that medical information on the Web should not receive the same scrutiny for its impact on clinical outcome and cost effectiveness as other methods of delivering the same information. Efforts to assess the quality of medical information are under way. For example, the Geneva-based Health on the Net Foundation has established a six-point code of conduct for sites providing medical information.16 In the United Kingdom, the Organising Medical Network Information initiative is attempting to provide a gateway to high quality biomedical information for the higher education and research communities.17 These initiatives to ensure quality of medical information on the Web are not attempts to stifle or censor information. Patients and medical practitioners are faced with an enormous quantity of information of variable quality, and the calls for rigorous adherence to quality are attempts to separate the wheat from the chaff, the useful from the harmful.11 The time has come for active regulation or accreditation of health care Web sites. After all, the health of the people of our global village is at stake. Martin B Van Der Weyden Editor, The Medical Journal of Australia Wheeler HB. Shotkick Lecture: healing and heroism. N Engl J Med 1990; 322: 1540-1548. Moloney TW, Paul B. Rebuilding public trust and confidence. In: Gertius M, Edgman-Levitan S, Daley J, Delbanco TL, editors. Through the patient's eyes. San Francisco: Jossey-Bass Publishers, 1993: 280-298. Consumer Health Forum of Australia Inc. Consultations on a health service standard report. A report to the Department of Health and Family Services on consumer community consultations. Lyons, ACT. Consumer Health Forum of Australia Inc, 1996. Daley J. Understanding and promoting patient centre care. In: Gertius M, Edgman-Levitan S, Daley J, Delbanco TL, editors. Through the patient's eyes. San Francisco: Jossey-Bass Publishers, 1993: 72-95. Coiera E. Guide to medical informatics, the Internet and telemedicine. London: Chapman and Hall, 1997: 275-292. PubMed: URL: http://www.ncbi.nlm.nih.gov/PubMed URL: http://www.healthfinder.gov National Institutes of Health. National Library of Medicine press release. 26 June 1997. URL: http://www.mja.com.au Impicciatore P, Pandolfini C, Casella N, Bonati M. Reliability of health information on the world wide web: systematic survey of advice on managing fever in children at home. BMJ 1997; 314: 1875-1879. Australian Vaccination Network: http://www.ozemail.com.au/~shotinfo/ Bower H. Internet sees growth of unverified health claims. BMJ 1996; 313: 381. Silberg WM, Lundberg GD, Musacchio RA. Assessing controlling and asuring quality of medical information on the Internet. JAMA 1997; 277: 1244-1245. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. JAMA 1997; 277: 927-934. Wyatt JC. Commentary: measuring quality and impact on the world wide web. BMJ 1997; 314: 1879-1881. Health on the Net Foundation. http://www.hon.ch Coiera E. The Internet's challenge to health care provision. BMJ 1996; 312: 3-4. - ©MJA 1997 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Mammographic screening in Australia Where are we, and where should we be going? MJA 1997; 167: 516-517 Breast cancer is the commonest cause of cancer death in women in Australia and screening is currently the principal means of reducing this toll. In terms of informing women about screening, the findings of the 1996 National Breast Health Survey, reported in this issue of the Journal by Barratt and colleagues, show that the message is getting through.1 Most women (89%) had heard of the program, 60% nominated mammography without prompting, and most were aware that women over 50 years should be screened every two years. Further, 87% of women aged 50-59 years reported ever having had a mammogram and half reported having been screened within the national program in the last two years. Mammographic screening is now accessible to most Australian women through one of the 36 screening and assessment services that are part of the national program. Community values and target age limits are issues for all cancer screening From a standing start, this is a remarkable achievement in a few years, and a model for what may be required for success in other areas of cancer screening, such as colorectal cancer. There are, however, a number of important policy issues that need to be addressed. The current combined Commonwealth and State funding for the BreastScreen program is of the order of $80 million per year.2 This provides for a 70% uptake of women in the 50-69 years age group plus 40% in the 40-49 years age group. Given the program's good track record, should funds be provided for its improvement or expansion? There are many policy options that can be considered. For example, raising the upper age limit for targeting and reinvitation (currently 69 years), lowering the age limit for targeting (from the current 50 years), reducing the screening interval, or trying to screen more women in the group already targeted. Of these options, the most contentious is the screening of women in the 40-49 years age group. Recently, additional follow-up of the seven randomised trials that included women aged 40-49 years has suggested a delayed benefit not apparent until after at least seven years. A second National Institutes of Health (NIH) consensus conference on the contentious issue of screening women in this younger age group in January this year concluded there was a statistically significant relative mortality reduction of 16% (95% CI, 2%-28%).3 In absolute terms, if there were about 36 deaths per 10 000 women aged 40-49 years, then regular screening "results in the extension of the lives of 0-10 women".3 The number of deaths prevented by screening women aged 40-49 has recently been estimated to be about one-third that in an equivalent number of 50-69-year-old women.4 The consensus panel also pointed out the disadvantages of screening -- false-negative and false-positive mammograms, the psychosocial consequences, and dilemmas such as the detection of ductal carcinomas-in-situ, some of which may never have become invasive. Rather than a blanket recommendation to screen, the consensus panel suggested each woman should decide for herself, but "should have access to the best possible relevant information regarding both benefits and risks, presented in an understandable and useable form". At the subsequent press conference, Dr Richard Klausner, the Director of the National Cancer Institute, stated that he was shocked by the report and announced that it would be reviewed by the National Cancer Advisory Board. Following a United States Senate hearing, the National Cancer Advisory Board voted 17 to one in favour of screening women aged 40-49 years every one to two years. Interestingly, in all this heated debate, no one asked the affected women how they felt about the benefit-harm tradeoff. At a recent Australian National Breast Cancer Centre consensus meeting about screening in 40-49-year-old women, Jill Cockburn (Head, Discipline of Behavioural Science in Relation to Medicine, University of Newcastle, NSW) reported national survey results that showed that most women in this age group felt that the benefits outweighed the risks. However, most also felt they should be given all the information and allowed to make up their own minds rather than there being a blanket recommendation to screen. Enthusiasm for screening also declined when information about the balance between the benefits and disadvantages was given. Similar declines in enthusiasm following receipt of appropriate information have been shown for prostate cancer screening5 and for cholesterol reduction in asymptomatic people.6 In an era of evidence-based practice and tight resources, involving target groups in screening decisions will be vital for formulating rational and acceptable policy. Community values and target age limits are issues for all cancer screening. In general, cancer incidence and mortality continue to rise with age, suggesting we should target older people. However, life expectancy also decreases with age, and the likelihood of dying of other causes before the cancer becomes troublesome increases. Combining the mortality and life expectancy information allows us to calculate age-specific "potential years of life lost"; this is shown for breast cancer in the Figure. There is a steady rise with age, reaching a peak late in the fifth decade, followed by a slow decline. This confirms the appropriateness of the age interval initially chosen by the BreastScreen program, but raises the difficult issue of where we should now draw the line on either side of the peak. This will depend on the balance of benefits and harms as we move away from the peak, and will require input from a representative community sample about their value judgements on the net worth of screening. If this did not give a clear-cut decision, individual informed consent should be required. With such community value judgements and an awareness of the costs, we could make a rational decision about how to best allocate Australia's resources for screening. Paul P Glasziou Reader in Clinical Epidemiology, University of Queensland Les M Irwig Associate Professor of Epidemiology, University of Sydney Barratt AL, Cockburn J, Redman S, Paul C, Perkins J. Mammographic screening: results from the 1996 National Breast Health Survey. Med J Aust 1997; 167: 521-524. Dorsch M. A perspective on the BreastScreen Australia experience. First National Breast Screening Conference; 1997 Aug 21-23; Canberra. Canberra: Commonwealth Department of Human Services and Health, 1997. National Institutes of Health Consensus Development Panel. National Institutes of Health Consensus Development Conference Statement: breast cancer screening for women aged 40-49, January 21-23, 1997. J Natl Cancer Inst 1997; 89: 1015-1026. Irwig L, Glasziou PP, Barratt A, Salkeld G. Review of the evidence about the value of mammographic screening in 40-49-year-old women. Sydney: NHMRC National Breast Cancer Centre, 1997. Flood AB, Wennberg JE, Nease RF, et al. The importance of patient preference in the decision to screen for prostate cancer. J Gen Intern Med 1996; 11: 342-349. Reed WW, Herbers JE, Noel GL. Cholesterol-lowering therapy: what patients expect in return. J Gen Intern Med 1993; 8: 591-596. Kricker A, Jelfs P. Breast cancer in Australian women 1921-1994. Canberra: Australian Institute of Health and Welfare, 1996. (Cancer Series No. 6.) <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>".

"Single use only": obfuscation or the necessary attainment of zero risk? Stringent reuse of medical devices could save us millions of dollars each year MJA 1997; 167: 519-520 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/MJA/>". Make a comment - - ©MJA1997 The revolution in plastics technology over the past 40 years has resulted in a wide variety of healthcare items produced as presterilised "single use only" disposables. In spite of the admonitions of many peak and government organisations in Australia and overseas,1-3 many hospitals are reprocessing single-use medical devices because staff feel this will result in substantial monetary savings.4 The labelling as "single use only" of non-critical items used exclusively on external body surfaces (as opposed to critical items used invasively), commented on by Stewart in this issue of the Journal, is an extremely relevant issue in the debate. Here, we argue that the global term "single use" provides a barrier to rational analysis by masking the complexity of the issues and the range of devices. Is a "single use only" item truly disposable, or is it a durable item that has been labelled "single use only" by the manufacturer according to certain criteria? Such criteria may include cost, life expectancy, potential physical or infection hazards after repeated use, minimisation of the manufacturer's legal liability, or even an expression of lack of confidence in the capability of hospitals to reprocess the item satisfactorily. Manufacturers would probably argue forcefully that all single-use labelling is appropriate Manufacturers would probably argue forcefully that all single-use labelling is appropriate, including that of non-critical items. Legal advice to many hospitals confirms the need to comply with manufacturers' instructions and thus precludes reprocessing. Nevertheless, infection control prin ciples suggest that, where an item of equipment is used externally against unbroken skin and does not penetrate a sterile site, thorough cleaning between uses is all that is required, and sterility is certainly not essential. Whether the reprocessing of such items is cost-effective may be questioned. However, if reuse of single-use, non-critical medical devices were prohibited by law, then logic demands that restaurants provide "single use only" crockery and cutlery to each patron -- as these items enter body cavities and are regularly contaminated with body fluids, they induce as much, if not more, risk of transmitting infection. Stewart advocates legislation to prohibit inappropriate labelling. As sensible as this suggestion appears, Australia constitutes less than 1% of the world market for single-use products, and overseas manufacturers are unlikely to change their labelling to meet requirements unique to our country. Reprocessing of "single use only" instruments that penetrate sterile body sites is an even more contentious issue. The recent National Health and Medical Research Council (NHMRC) expert report,5 which examined reuse of critical items, confirmed the economic rationality of reprocessing some "single use only" items by stating that if such reuse was not permitted in Australia "either appropriate resources (estimated at $100 million per annum) to purchase sufficient single use devices must be provided or a reduction in services be explicitly recognised". However, the NHMRC panel also concluded that "continuation of the current practice of re-use cannot be condoned", and suggested that either Australian health ministers make a decision to disallow reuse of medical devices labelled as "single use only", or allow reuse to continue but that it be subject to more stringent regulations. Although State and Commonwealth departments of health do not support reuse,6-8 the dilemma for many hospitals continues because they implicitly recognise that it is in their interests for services to continue without the imperative to obtain increased funding to purchase further stocks of single-use equipment. Therefore, reprocessing, although against written policy, is tolerated by governments. From the patient's perspective, there is both an expectation and a legal right to be assured that any equipment used is devoid of infection risk, as well as being non-toxic, non-pyrogenic, physicochemically stable and functionally reliable. To what extent does the healthcare consumer require this assurance? The outcome in the recent Sydney case of patient-to-patient transmission of HIV9 suggests that the judiciary, presumably reflecting a community view, believes that zero risk should be the accepted standard. By this precedent, any reprocessing of "single use only" items is likely to be unacceptable to the community, in spite of scientific argument to the contrary and the economic implications of such a decision. No one who has seriously considered this issue could deny that a policy on the reprocessing of critical items marked as "single use only" will be difficult to formulate, or that prospective and scientifically rigorous data on their potential transmission hazards are urgently needed. In response to the NHMRC document, the Australian Health Ministers Advisory Council (AHMAC) has commissioned detailed studies into the risk of disease transmission by cardiac electrophysiology catheters and their ability to be satisfactorily reprocessed (Dr H Wellington, Chair, NHMRC working party on re-use of medical devices labelled as single use, personal communication). The alternatives provided by the NHMRC expert panel represent two diametrically opposed solutions to the problem. To continue disposing of all items labelled as "single use only", regardless of their ability to be adequately re-processed, creates unnecessary expense at a time when healthcare dollars are scarce. To agree to the reprocessing of certain items may lead to opposition, particularly from manufacturers. Nevertheless, if, after expert advice, the community and its parliamentary representatives can agree on an acceptable, practical and economically attainable level of risk, then appropriate characterisation of those devices suitable for reprocessing under stringent conditions could save Australia's healthcare system millions of dollars each year. While acknowledging that it is a challenging question, it is one that Australia's health ministers must consider, and one on which they must develop and disseminate a collective view. We hope that the relevant issues will continue to be debated by AHMAC. R Michael Whitby Director, Department of Infectious Diseases Infection Control & Sexual Health, Princess Alexandra Hospital, Brisbane, QLD David F M Looke Senior Specialist, Department of Infectious Diseases Infection Control & Sexual Health, Princess Alexandra Hospital, Brisbane, QLD Federation of Sterilising & Research Advisory Councils of Australia. FSRACA policy statement: re-use of single-use items. Melbourne: FSRACA, 14 Feb 1994. Medical Industry Association of Australia. Statement of Industry Policy: re-use of single-use medical devices. Sydney: MMIA, 6 Aug 1991. United States Food and Drug Administration. Compliance Policy Guide. Re-use of medical disposable devices, 7124.6. Washington, DC: FDA, 24 Sept 1987. Collignon PJ, Graham E, Dreimanis DE. Re-use in sterile sites of single-use medical devices: how common is this in Australia? Med J Aust 1996; 164: 533-536. National Health and Medical Research Council. Report of the NHMRC expert panel on re-use of medical devices labelled as single use. Canberra: AGPS, 1997. Adams A (Chief Medical Adviser, Commonwealth Department of Human Services and Health). Communication: re-use of single-use devices. Canberra: DHSH, 1 Aug 1994. Owen JW (Director-General, New South Wales Health). Reuse of single-use medical devices. Sydney: NSW Health, 1994. (Draft Circular 83/62.) Lynch P (Acting Chief Medical Officer, Victorian Department of Health and Community Services). Re-use of disposable single-use items. Melbourne: DHCS, 29 January 1993. (Circular No. 2/1993.) Chant K, Lowe D, Rubin G, et al. Patient-to-patient transmission of HIV in private surgical consulting rooms [letter]. Lancet 1993; 342: 1548-1549. <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Automation in cervical cytology: whose cost and whose benefit? Our first priority should be to screen more women, and not to offer more screening to those who can pay MJA 1997; 167: 460-461 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1997 Recently, women and doctors have been exposed to high pressure marketing about automated cervical cytology. Questions as to whether the patient is "getting the right Pap smear", and messages that doctors don't know what is being missed have created a climate of uncertainty and anxiety among both patients and practitioners. Population screening for cervical cancer by Pap smear has undoubtedly had a major impact on both morbidity and mortality from cervical cancer,1 a malignant disease which, on a worldwide basis, is the commonest cause of cancer death in women. The success of cervical screening has raised expectations for a perfect system and has also directed focus to its failures. Failures can occur at any point of the screening pathway: at recruitment, sampling, laboratory processing, notification, and in the management of women in whom abnormalities are detected.2 While systematic efforts have been made to improve each step of the pathway, the major failure remains the inability to persuade all women to undergo regular Pap smears: figures from the NSW Pap Test Register suggest that only 67% of women at risk of cervical cancer are screened in accordance with the national policy of biennial Pap smears.3 The remainder are failing to take advantage of the well established health benefits of regular conventional Pap smear screening. The current marketing strategy runs the risk of reducing confidence in the existing system and of introducing apparent inequity into cervical screening Attempts to reduce laboratory error in the processing of Pap smears have encouraged the automation of cytology, with developments on three fronts. Firstly, the use of liquid-based smear preparation which prepares a monolayer of cells on a slide in the laboratory; secondly, the use of microscope tracking to ensure that the cytotechnologist examines all areas of a slide; and thirdly, computer-assisted image analysis to rescreen conventionally prepared smears. All procedures ultimately rely on conventional cytopathology review and "they still do not detect all abnormal cases".4 Some of these techniques have been heavily marketed, both directly to women and to general practitioners, and none currently carry a Medicare rebate. The role of automated cervical cytology in Australia is currently being evaluated by an Australian Health Technology Advisory Committee Working Party and its report is expected shortly. This Journal has previously reported the experience of one Australian laboratory with a computerised rescreening technique, PapNet,5 and, in this issue Roberts and colleagues report the findings of another large laboratory on the use of a liquid-based technology, ThinPrep, as an adjunct to the conventional Pap smear.6 Both papers suggest a slight improvement in detection of abnormalities. The medical community must remain cautious in assessing the true place of such technology. These techniques have been marketed as offering improvements in laboratory quality assurance and thereby reducing false negatives. Additional claims for the liquid-based techniques (which prepare better slides) are that sampling is improved and the number of unsatisfactory samples reduced. They also theoretically open the way for additional tests such as typing for certain strains of human papilloma virus (HPV). As with all of the automated strategies, the impact on clinical outcomes of HPV testing still remains conjectural. The performance of automated techniques in quality assurance should be assessed against other methods of quality assurance, such as random rescreening of a mandated proportion of smears, directed rescreening of "high-risk" groups and "rapid rescreening". Mathematical models show that manual methods of rescreening provide superior cost-benefit ratios when compared with automated approaches.7 This conclusion was also reached by the Canadian Coordinating Office for Health Technology Assessment in its assessment of automated cytology,8 and is supported in a letter in this issue of the Journal by Gurley et al.9 Pathologists should be encouraged to establish the best and most cost-effective method of quality assurance and not simply pass on the cost of the most expensive method of quality assurance to consumers. The scientific assessment of these procedures has been clouded by opinions about potential medicolegal consequences for failure to recommend the use of such tests.10 Such suggestions fail to recognise that proof of medical negligence must involve a deviation from the standard of care, which is ultimately decided by the courts, but depends on the ordinary care and skill of a particular category of practitioner. Australian medical negligence cases involving cervical cancer have focused on the failure of doctors to take steps to either diagnose or exclude a diagnosis of cervical cancer in the presence of a range of symptoms. While the relative costs and benefits of automated cytology remain a subject of considerable debate, and without government endorsement of these techniques, it seems highly unlikely that a court would expect a doctor to recommend such additional tests in an asymptomatic patient. The size of the problem needs to be kept in perspective. From Victorian Cytology Register figures correlating screening histories on women who die from cervical cancer, it has been estimated that at most, eight Victorian women dying from cervical cancer each year could identify laboratory error as a factor.11 Adding $20 for ThinPrep and $30 for PapNet to each of the 600 000 smears done in Victoria each year would add $30 million to the laboratory costs of cervical screening.11 Nationally this figure would amount to approximately $70 million, and the health care community must ask whether this is the best use of available resources. With some innovative consideration of alternatives, this money could be applied to other areas with likely better outcomes. For example, one alternative may be to pay GPs a Medicare rebate for taking a Pap smear on a previously unscreened older woman. Offering a $20 rebate for every 50-70-year-old unscreened woman in Australia would cost around five million dollars per annum, and could be expected to prevent a substantial number of cervical cancers in this group most "at risk". The case for a massive investment of public funds into these technologies appears small, and Australian taxpayers should not be expected to bear the full cost of their development when other health systems have failed to endorse them. While providing advice and information to patients is part of the standard of care, health practitioners are not agents for commercial enterprises. The right of individual women to spend their own money on items of their choice is to be respected, but their choice should be free and informed. The health gain from such a purchase needs to be clear to women and represented accurately: the available information on this technology suggests that the incremental benefit of automated cytology over conventional cytology is really quite small, and is unlikely to be substantially better than having a repeat Pap smear two years later.12 The current marketing strategy runs the risk of reducing confidence in the existing system and of introducing apparent inequity into cervical screening -- a particular problem when screening rates are lowest and cervical cancer incidence is highest in women of low socioeconomic status.13 Finally, in the current medicolegal environment, suggesting that there may be legal implications for doctors who do not recommend these automated tests to their patients is unwelcome and unusually coercive. Gerard V Wain Director, NSW Cervical Screening Program, Westmead Hospital, NSW Mitchell HS, Giles GG. Cancer diagnosis after a report of negative cervical cytology. Med J Aust 1996; 164: 270-273. Koss L. The Papanicolou test for cervical cancer detection: a triumph and a tragedy. JAMA 1989; 251: 737-743. Cervical Screening in NSW: situation analysis, February 1997. Sydney: NSW Cervical Screening Program, 1997. Statement on technical devices for innovation in cervical cytology screening [editorial]. Am J Clin Pathol 1996; 106: 441. Farnsworth A, Chambers FM, Goldschmidt CS. Evaluation of the PAPNET system in a general pathology service. Med J Aust 1996; 165: 429-431. Roberts JM, Gurley AM, Thurloe JK, et al. Evaluation of the ThinPrep Pap test as an adjunct to the conventional Pap smear. Med J Aust 1997; 167: 466-469. Hutchinson M. Assessing the costs and benefits of alternative rescreening strategies. Acta Cytologica 1996; 40: 4-7. Assessment of techniques for cervical cancer screening. Ottawa: Canadian Coordinating Office for Health Technology Assessment, 1997. Gurley AM, Roberts JM, Thurloe JK, et al. Increasing the accuracy of the Pap test [letter]. Med J Aust 1997; 167: 507. Saunders C. Pap smear wizardry: new technologies raise difficult questions. Aust Doctor 1997; 27 June: 28-32. Check W. Too early to solve Pap device puzzle. CAP Today June 1997;11: 6. Mitchell H, Medley G. Detection of laboratory false negative smears by the PapNet cytological screening system. Acta Cytologica 1997. In press. Smith D, Taylor R, Coates M. Socioeconomic differentials in cancer incidence and mortality in urban New South Wales, 1987-1991. Aust N Z J Public Health 1996; 20: 129-137. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

How can we best achieve optimal transfusion practice? Before optimal practice can be promoted, it must be defined MJA 1997; 167: 462-463 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1997 Most therapeutic agents are prescribed within a framework of licensed indications agreed between the manufacturer and a regulatory authority. However, single donor blood components are not subject to this form of licensing, and rarely is rigorous evidence of their efficacy available from large scale randomised studies, as there is for other therapeutic agents, such as drugs. In an era when medical practice is increasingly governed by the threat of litigation, the proper use of blood products is particularly sensitive and closely scrutinised. Prescription of blood products based solely on presumed benefit, without balancing the risks of infection and other complications, is no longer acceptable. Yet, achieving the correct balance requires sound evidence of efficacy, accurate risk assessment and effective methods of ensuring universal good transfusion practice. How close are we to achieving this? Recent evidence suggests that a common understanding of the efficacy of blood components is a long way off. The Royal College of Physicians of Edinburgh consensus statement on red cell transfusion concluded: "...there is no general agreement at which point transfusion should be given, or on the optimal target concentration to be achieved. There is no single haemoglobin or haematocrit value applicable to all patients."1 For platelet transfusion, the "transfusion trigger" is more clearly defined. Even so, it was revised from 20x109/L to 15x109/L, or even 10x109/L in 1991.2 Further, a review of surgical transfusion practice in 43 hospitals in 10 countries of the European Union (the SANGUIS study) found that use of blood components in five common surgical procedures (hemicolectomy, coronary artery bypass grafts, abdominal aortic aneurysmectomy, transurethral resection of the prostate, total hip replacement) ranged from 0 to 80% of procedures for whole blood, 0 to 50% for fresh frozen plasma and 0 to 15% for platelets.3 Consequently, the cost in blood products varied by a factor of four for coronary artery bypass grafts, and a factor of 16 for transurethral resection of the prostate. limiting use of blood components to occasions when they are strictly necessary would benefit patients, prescribers, suppliers and society If efficacy is difficult to define, are we better at assessing transfusion risk? Transfusion-transmitted infections are the focus of concern for prescribers and the public alike, and studies on this topic are welcome.4 However, national requirements for reporting and collating major transfusion hazards vary. The United States5 and France have mandatory reporting, and the United Kingdom recently launched voluntary reporting.6 Australia also has voluntary reporting systems in all States, but these are believed to be underutilised (Dr Gordon Whyte, Director, Victorian Red Cross Blood Bank, Melbourne, VIC, personal communication). However, although such data-gathering is critical for monitoring risk, there is no evidence as yet that it is effective in moderating transfusion prescribing. Even if best transfusion practice could be formulated, how could it be promoted? In this issue of the Journal, Tuckfield et al. assess one strategy -- prospective monitoring of blood product request forms.7 They found that, assessed on hospital guidelines, this approach markedly reduced the rate of inappropriate transfusions. This systematic review of blood product prescriptions may be more educational and have longer lasting effects than would a paper audit. However, it has the disadvantages of being labour intensive and possibly delaying treatment, and is probably not applicable on a regular basis. A range of other strategies have been used, including issuing of national guidelines, consensus conferences and devolution of budgets to prescribers. All have their drawbacks. For example, guidelines produced at the national level have the potential to reflect local practice as well as scientifically validated assessments. The guidelines used by Tuckfield et al. could be challenged on the same basis. The SANGUIS study suggests that basing guidelines on current practice would lead to dramatically different criteria in different European countries, against which, in case of litigation, physicians might be judged. In addition, results of strategies are not always as expected. After publication of national guidelines for use of fresh frozen plasma (FFP) in the UK,8 FFP issues from our blood centre actually increased, as subtherapeutic doses had often been used previously. In contrast, FFP use in Belgium decreased dramatically after a safer but more expensive product (virally inactivated FFP) was introduced without an overall budget increase. Ultimately, limiting use of blood components to occasions when they are strictly necessary would benefit patients, prescribers, suppliers and society. Patients would receive optimal treatment with the lowest risk of side effects and, in some countries, minimum out-of-pocket cost. Prescribers providing treatment according to guidelines would offer state-of-the-art care and be protected from legal action in the rare case of a nosocomial event. Suppliers would be able to supply products more easily because of decreased demand. In addition, by fulfilling their duty to ensure maximum precautions are taken to provide safe blood components according to, and sometimes beyond, national recommendations or regulations, and to inform providers of potential risks, suppliers would protect themselves from potential litigation. (For example, in the United Kingdom some blood centres introduced systematic screening for hepatitis C antibodies before it became mandatory.) At the end of this process, society would benefit, with optimal use of limited resources in the context of growing health expenditure. However, before rushing headlong into further expensive manoeuvres to improve transfusion practice, we should remember that the relative cost-effectiveness of guidelines, consensus conferences and other strategies, such as prospective monitoring, in changing transfusion practice has not been assessed. Failure to change practice is often blamed on the prescribers rather than on the limitations of the methods used. But who will audit the auditors? Jean-Pierre Allain Professor of Transfusion Medicine, Department of Haematology, University of Cambridge, Cambridge, United Kingdom. Lorna M Williamson Consultant and Lecturer, National Blood Service, East Anglia Centre, Cambridge, United Kingdom. Consensus statement on red cell transfusion. Transfus Med 1994; 4: 177-178. Gmur J, Burger J, Schanz U, et al. Safety of stringent prophylactic platelet transfusion policy for patients with acute leukaemia. Lancet 1991; 338: 1223-1226. Sirchia G, Giovanetti AM, McClelland B, Fracchia GN, editors. Safe and good use of blood in surgery (SANGUIS). European Commission Publisher, 1994. Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitted viral infections. N Engl J Med 1996; 334: 1685-1690. Linden JV, Tourault MA, Scribner CL. Decrease in frequency of transfusion fatalities. Transfusion 1997; 37: 243-244. Williamson LM, Heptonstall J, Soldan K. A SHOT in the arm for safer blood transfusion. BMJ 1996; 313: 1221-1222. Tuckfield A, Haeusler M, Grigg A, Metz J. Reduction of inappropriate use of blood products by prospective monitoring of transfusion request forms. Med J Aust 1997; 167: 473-476. British Committee for Standards in Haematology. Guidelines for the use of fresh frozen plasma. Transfus Med 1992; 2: 57-63. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Hip fractures and osteoporosis in men Drug therapies for men must be based on studies in men MJA 1997; 167: 404-405 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - ©MJA1997 In 1990, 30% of the 1.7 million hip fractures worldwide occurred in men.1 The absolute number of hip fractures will increase with the growing number of elderly people, and with the increasing age-specific incidence of hip fractures.2 The predicted number of hip fractures worldwide for the year 2025 is 1.2 million in men and 2.8 million in women.1 In this issue of the Journal, Diamond et al.3 report a 20% mortality within six months of hip fracture among elderly men. While fracture-related complications in the men were comparable with those of randomly selected age-matched women with hip fracture, 14% of men died during admission, compared with only 6% of women. This difference was not statistically significant, and women were not followed after discharge, so further comparison of mortality was not possible. Interestingly, 32% of men and 28% of women were admitted from institutions where protein malnutrition, vitamin D deficiency, illness, falls and hip fractures are more common than in the community;4 50% of men and 42% of women were discharged to institutions. Despite important limitations of this study -- its small sample size (only 51 men, with 10 lost to follow-up) and the absence of control groups -- it does highlight the high morbidity and mortality associated with hip fractures in elderly Australians, and suggests that mortality may be higher in men than in women. In this, it concurs with the findings of Poor et al., who reported a mortality of 20.7% in men and 7.5% in women with hip fractures.5,6 Among the 131 men they studied, hospital mortality was 11.5% and 30-day mortality was 16%, while 79% of the survivors resided in nursing homes at one year. The problem of osteoporosis and fractures in men is likely to increase Fifty-eight per cent of these 131 men, compared with 94% of the age-matched community-residing male controls, were alive at one year, and the risk of death increased with higher levels of coexisting illness, age and with activity status at the time of fracture.6 Immediately after fracture, overall survival was similar for both patients and controls who had no pre-existing comorbid conditions. Survival was reduced for both groups with increasing numbers of coexisting illnesses, and was lower in the cases than controls at each level of comorbidity (see Box). Dementia, cerebrovascular disease, chronic lung disease, congestive heart failure and myocardial infarction significantly influenced survival. As neither fracture alone nor illness alone accounted for the excess mortality, it seems an interaction between fracture and its consequences with the coexisting illnesses may be responsible. Bone strength is determined by bone size, mass and architecture. Men with fractures have smaller bones than controls: those with femoral neck fractures have reduced femoral neck width, and those with spinal fractures have reduced vertebral body width. Bones may be smaller because of reduced peak bone size and reduced periosteal appositional growth. Smaller bones have lower bone density because they have attained a lower peak bone mass or because bone has been lost. Osteoporosis in old age is the result of genetic and environmental factors during growth and ageing, and both periods need to be studied. Hypogonadism during growth and delayed puberty may result in reduced peak bone size and bone density. Later in life, age-related hypogonadism and the resultant decline in testosterone levels may contribute to bone loss. Hypogonadism is present in around 20% of elderly men in the community (own unpublished data), and in around 50% of men with spine or hip fractures.7 Osteoporosis can also result from vitamin D deficiency, which is common among institutionalised elderly men, and may cause osteomalacia, secondary hyperparathyroidism, increased bone turnover and bone loss. Bone loss accelerates (rather than ceases) in elderly men or women with secondary hyperparathyroidism, partly because this condition causes increased intracortical porosity and cortical thinning which predispose to hip fractures. Excessive alcohol consumption (also noted by Diamond et al.), is an important attributable risk factor for osteoporosis in men. There is no proven treatment for osteoporosis in men because there have been no appropriate randomised controlled trials. Calcium supplements are safe and may slow bone loss, at least in women.8 Vitamin D deficiency should be suspected in housebound or institutionalised elderly men and should be treated (after excluding malabsorption) with daily vitamin D supplements. The purported efficacy of 1 a ,25-dihydroxyvitamin D3 for osteoporosis in women has led to it being approved in Australia for treating osteoporosis in men. Hypogonadism should be treated with testo sterone (which may increase bone mineral density [BMD] in eugonadal men, but only short term trials have been done). The possible increased risk of prostatic cancer associated with testosterone therapy needs to be considered in any cost-benefit analysis. Several small short term trials in men with idiopathic or secondary osteoporosis suggest that bisphosphonates increase BMD and reduce bone turnover. Studies in women with primary osteoporosis, and in animals suggest that drugs such as alendronate and etidronate appear to be the best options at this time. However, as long term safety data are limited, these drugs must be given cautiously. The bisphosphonates may remain in bone indefinitely, alendronate can cause gastric irritation or oesophageal ulceration, and etidronate can cause focal osteomalacia when given for prolonged periods. Sodium fluoride increases BMD but not bone strength and should not be used in osteoporosis in men or women. There is no evidence for a favourable effect of anabolic steroids in men. The problem of osteoporosis and fractures in men is likely to increase. To use drugs in men based on evidence from studies in women is not an appropriate long term solution. Drug therapy for men must be based on studies of efficacy, safety and quality of life in men. As with all measures in preventive medicine, potential drug therapy must be safe because most people who are treated derive no benefit. For example, if the incidence of fracture is two per 100 men per year, and a drug has a 50% antifracture efficacy, in any year 98 men will not have had a fracture with or without treatment, one will have a fracture anyway, and, in one, fracture will be prevented -- 99 will derive no benefit. Clearly, treatments must be safe. Age-specific hip fracture incidence rates in men with low BMD must be determined prospectively to enable us to establish drug efficacy. For example, if the incidence of fracture is two per 100 men per year, 1260 men with hip fracture and 1260 controls will be needed to detect a 50% risk reduction by a drug in a three-year study. Smaller sample sizes may be adequate if high risk groups with low baseline BMD and fractures are recruited. Studies with endpoints such as BMD, histomorphometry, biochemical measurements of bone turnover and biomechanical testing of bone biopsy specimens may provide at least some clarification of appropriate drugs for use in men. Ego Seeman Associate Professor of Medicine, Austin & Repatriation Medical Centre, University of Melbourne, VIC Cooper C, Campion G, Melton LJ. Hip fractures in the elderly: a world-wide projection. Osteoporosis Int 1992; 2: 285-289. Seeman E. Osteoporosis in men. Aust Fam Physician 1997; 26: 135-143. Diamond TH, Thornley SW, Sekel R, Smerdley P. Hip fracture in elderly men: prognostic factors and outcomes. Med J Aust 1997; 167: 412-415. Rudman IW, Rudman D. High rates of fracture for men in nursing homes. Am J Physical Med 1989; 68: 2-5. Poor G, Atkinson EJ, Lewallen DG, et al. Age-related hip fractures in men: clinical spectrum and short-term outcomes. Osteoporosis Int 1995; 5: 419-426. Poor G, Atkinson EJ, OOFallon WM, Melton LJ III. Determinants of reduced survival following hip fractures in men. Clin Orthop 1995; 319: 260-265. Stanley HL, Schmitt BP, Poses RM, Diess WP. Does hypogonadism contribute to the occurrence of a minimal trauma hip fracture in elderly men. J Am Geriatr Soc 1991; 39: 766-771. Reid IR, Ames RW, Evans MC, et al. Long term effects of calcium supplementation on bone loss and fractures in post menopausal women -- a randomized controlled trial. Am J Med 1995; 98: 331-335. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Ego Seeman

Driving and dementia: balancing personal independence and public safety Drivers with dementia require standardised on-road assessment of their driving safety MJA 1997; 167: 406-407 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - ©MJA1997 In this issue of the Journal, Lipski addresses the important topic of driving by people with dementia.1 Although older drivers drive fewer kilometres than younger drivers, and are less likely to drive at night or in heavy traffic, their crash rate per kilometre driven may be the highest of any age group, and they are more likely to be killed when involved in a crash.2 Several retrospective studies have found that people with dementia are involved in more accidents than age-matched control subjects, and that many drivers with dementia continue to drive despite having had crashes.3-5 Notably, these studies do not agree on issues such as whether the duration of the dementia is an accurate predictor of driving ability, and many rely on reports by caregivers of driving history and crashes, the reliability of which are uncertain. Recent neuropathological findings in 98 older drivers killed in traffic accidents showed that 33% had neuritic plaque scores indicating certain Alzheimer's disease (AD) and, in a further 20%, findings were suggestive of AD.6 This raises the possibility that more accidents are attributable to AD than previously thought. In contrast, another study of Michigan State records showed that road crash and violation rates among AD patients did not differ significantly from those of matched controls;7 this study did not control for mileage driven, and reduced driving exposure of AD patients may have kept their crash rate equal to that of control subjects. Drachman and Swearer investigated crash rates for patients with AD over a 10-year period.8 They also did not control for mileage driven, but found that, although the AD patients had fewer reported crashes than 16-24 year old drivers, they had more than twice as many in the years after the onset of their AD, than matched control subjects. Doctors cannot reliably predict driving competence or increased crash risk in drivers with AD on the basis of a clinical examination There are few reports on actual driving performance of people with dementia. Fitten and colleagues examined the performance of patients with mild AD and patients with mild vascular dementia.9 Compared with control groups, the groups with AD and vascular dementia had lower mean scores on the driving test and made more errors in the complex stages of the course. In addition, a retrospective analysis of crashes and driving violations for these patients was consistent with road test results. However, Hunt and colleagues found that, while 40% of drivers with mild dementia of the Alzheimer type (DAT) were unsafe, some others may drive safely. The driving competency of individuals with DAT could not be determined reliably from self report.10 Fox and colleagues found that 63% of licensed drivers diagnosed with probable AD failed a standardised on-road evaluation.11 Conversely, 37% passed this evaluation, suggesting that a diagnosis of AD alone may be insufficient justification for stopping people from driving. These studies of on-road driving behaviour of patients with dementia indicate that older drivers with a range of cognitive abilities can be safely and reliably evaluated by a road test, with validity equal to that of driver licence tests. As noted by Lipski,1 while data increasingly show risks to individuals and the community associated with driving by people with dementia, there are few guidelines for helping doctors determine who can or cannot drive. This assessment may be further complicated if any of the new drugs currently undergoing clinical trial for AD are found to enhance performance on cognitive or driving tasks. Doctors cannot reliably predict driving competence or increased crash risk in drivers with AD on the basis of a clinical examination.10 There is also a lack of consensus about the predictive validity of neuropsychological assessment for driving competence among patients with dementia, partly because of the different neuropsychological tests employed in different studies. While the Mini Mental State Examination has been proved to significantly predict driving competence in studies of patients with dementia, its specificity and sensitivity were not sufficient for efficient prediction of driving safety.11 In the light of recent empirical data, we recommend that if a doctor learns that an older patient gets lost while driving or has been involved in a crash, the possibility of a progress ive dementing illness as a cause of their driving difficulties should be investigated. In many cases, licence cancellation may be indicated without on-road assessment. If licence cancellation threatens a general practitioner's long term relationship with a patient and his or her family, referral to an appropriate specialist may be preferable. In cases of disagreement, an on-road driving test may help the family, and possibly the patient, accept that the patient is incompetent to drive. In patients for whom unsafe driving behaviours have not been reported, an on-road assessment is currently the most valid means of determining driver competence and safety. The driving test should be standardised, designed for neurologically impaired people, include some complex traffic situations, and, ideally, should be available in both urban and rural areas. It has been suggested that patients with dementia who drive with the assistance of a passenger or "copilot" should be assessed with, and subsequently permitted to drive with, the "copilot".12 However, several logistic and legal problems (surrounding such questions as: Who is licensed to drive? How can the presence of the "copilot" be ensured? Can the cognitive status of the "copilot" be monitored?) render this proposal impractical. For patients whose driving tests indicate safe and competent driving, driving performance must be reviewed regu larly (e.g., six-monthly), or after a noticeable increase in dementia severity. Criteria for driving competence and licence cancellation should be discussed with the patient and family. If assessment indicates that the patient should stop driving, the patient and family should be involved in discussion of transport alternatives which may be available from family or friends, or through community transport options. Counselling of the patient and family about lifestyle changes and future planning of transportation may be critical to compliance as well as to psychological wellbeing, as driving cessation may be associated with depressive symptoms. As a society, we need to devote more planning and resources to provision of safe, convenient and affordable transportation alternatives for those unable to drive. Gillian K Fox Clinical Neuropsychologist, Rehabilitation Studies Unit, University of Sydney, NSW. Guy M Bashford Staff Specialist, Department of Rehabilitation and Geriatrics, Illawarra Area Health Service, Warrawong, NSW Lipski PS. Driving and dementia: a cause for concern. Med J Aust 1997; 167: 453-454. Waller PF. Renewal licensing of older drivers. Transportation in an aging society. Vol. 2. Washington, D. C.: Transportation Research Board, 1988: 72-100. Friedland RP, Koss E, Kumar A, et al. Motor vehicle crashes in dementia of the Alzheimer type. Ann Neurol 1988; 24: 782-786. Lucas-Blaustein MJ, Filipp L, Dungan C, Tune L. Driving in patients with dementia. J Am Geriatr Soc 1988; 36: 1087-1091. Gilley DW, Wilson RS, Bennett DA, et al. Cessation of driving and unsafe motor vehicle operation by dementia patients. Arch Intern Med 1991; 151: 941-946. Johansson K, Bogdanovic H, Kalimo H, et al. Alzheimer's disease and apolipo- protein E e 4 allele in older drivers who died in automobile accidents. Lancet 1997; 349: 1143-1144. Trobe JD, Waller PF, Cook-Flanagan CA, et al. Crashes and violations among drivers with Alzheimer disease. Arch Neurol 1996; 53: 411-416. Drachman DA, Swearer JM. Driving and Alzheimer's disease: the risk of crashes. Neurology 1993; 43: 2448-2456. Fitten LJ, Perryman KM, Wilkinson CJ, et al. Alzheimer and vascular dementias and driving. JAMA 1995; 272: 1360-1365. Hunt L, Morris JC, Edwards D, Wilson BS. Driving performance in persons with mild senile dementia of the Alzheimer type. J Am Geriatr Soc 1993; 41: 747-53. Fox GK, Bowden SC, Bashford GM, Smith DS. Alzheimer's disease and driving: prediction and assessment of driving performance. J Am Geriatr Soc 1997; 45: 949-953. Shua-Haim JR, Gross JS. The "co-pilot" driver syndrome. J Am Geriatr Soc 1996; 44: 815-817. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Gillian K Fox · Guy M Bashford

Public health and politics: the demise of the ACT heroin trial Where is the commitment to evidence-based medicine? MJA 1997; 167: 348-349 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1997 The communique issued by the Ministerial Council on Drug Strategy (MCDS) meeting on 31 July 1997 stated: "If a number of preconditions can be met, the ACT Government [will] undertake a small trial of the controlled availability of heroin involving 40 people". Yet on 19 August, Federal Cabinet stopped the trial on the doubtful grounds that the Commonwealth would be required to pass special legislation permitting importation of heroin -- a claim contested by both the Federal Attorney General and the Health Minister. The Prime Minister also claimed that a rigorous trial of medically prescribed heroin was tantamount to legalisation and would "send the wrong message".1 What messages of certainty did the Prime Minister and Cabinet send by extinguishing the heroin trial? Firstly, that the lucrative profits of illicit drug trafficking, the very engine of this problem, would not be threatened. Secondly, that this problem will continue to be dealt with predominantly by law enforcement, an approach now widely recognised to be prohibitively costly and hopelessly impractical.2 The decision also sends a powerful message to medical researchers throughout Australia. Six years of careful scientific work on a significant community problem, widespread consultation, publications in quality peer-reviewed journals, openness to scientific scrutiny,3 support by the Australian Medical Association, presidents of medical colleges, numerous leaders of the medical profession, police commissioners, directors of public prosecution and a royal commissioner are not enough. An important, but controversial, scientific research project will be brought down politically if opposed by 51% of respondents in a community opinion poll4 and if subjected to a relentless campaign of media vilification and misinformation (Media Watch, ABC Television, 9.30 pm, 1 September 1997). This makes a mockery of the present government's advocacy of evidence-based medicine. Federal Cabinet's decision follows a long-standing tradition of basing policy in the illicit drug area on politics rather than science. Federal Cabinet's decision follows a long-standing tradition of basing policy in the illicit drug area on politics rather than science. Pharmacological fundamentalism even prevents doctors from recommending the option of smoking cannabis for palliating the intractable symptoms of terminal illnesses.5 The frequency of major inquiries into illicit drug use in Australia (at least 25, including Royal Commissions, in the past 25 years)6 suggests both considerable community anxiety as well as doubt about the effectiveness of current policy. Between 1979 and 1995, heroin-related overdose deaths increased from 10.7 per million population to 67 per million.7 Other illicit drug outcomes have also deteriorated alarmingly, while illicit drug law enforcement cost an estimated $1.7 billion in 1992.8 A Parliamentary Committee concluded that "all the evidence shows, however, not only that our law enforcement agencies have not succeeded in preventing the supply of illicit drugs to Australian markets but that it is unrealistic to expect them to do so".9 While generous funding continues for illicit drug law enforcement in the absence of demonstrable benefit, funding for treatment remains limited despite generally impressive outcomes. Methadone maintenance treatment is supported by overwhelming evidence of safety, effectiveness in improving health outcomes, reducing deaths, reducing crime and improving social functioning.10 The total cost of all methadone programs in Australia was estimated recently to be $40 million per annum,11 met by Commonwealth, State and Territory governments and by patients. Pharmacological treatments, especially methadone, are far more effective at attracting and retaining heroin-dependent patients than non-pharmacological treatments. The median duration of stay in drug-free rehabilitation facilities is only three to four weeks12 compared with about two years for methadone.13 Methadone maintenance is not attractive to all seeking pharmacological treatment and is not effective for all prepared to try it. When it comes to pharmacological treatment for heroin dependence, one size certainly does not fit all. Hence the need to expand the range of pharmacotherapies. Heroin was only one of a number of pharmacological agents to be evaluated for the management of heroin dependence. The MCDS also supported the evaluation of a number of other agents, including the opioid antagonist naltrexone, the long-acting agonist l- a-acetylmethadol (LAAM), the agonist-antagonist buprenorphine, and sustained release oral morphine. These trials are to go ahead. An official decision to support a heroin trial became difficult to oppose on any logical grounds after the final results of the Swiss heroin trial were released recently.14 Health outcomes of this trial were extremely impressive. Among 1146 subjects treated for 18 months, there were no overdose deaths, only three new HIV infections, four new hepatitis B infections and five new hepatitis C infections. Reported income from illicit and semi-legal activities decreased from 69% to 10%, the number of offences dropped by 60%, court convictions declined significantly, employment increased from 14% to 32%, and there were net savings of approximately $A45 per patient per day. It is difficult to think of any new law enforcement, education or treatment approach in the illicit drug field in the past 30 years which can boast such promising results. Why have the health, social and economic outcomes from illicit drugs in Australia continued to deteriorate for so many years? Firstly, there has been a systematic failure to collect relevant evidence (such as would be obtained from a heroin trial). Secondly, policy (including funding) has been based on ideology rather than evidence. If we want to help drug users lead normal and useful lives and offer some hope to their families and their communities, the first step is an unswerving commitment to evidence-based policy and practice without political interference. Tragically, in this country illicit drug policy has become inviolable while politicans remain terrified of losing an election lest rationality be misinterpreted as "being soft on drugs". The 1997 MCDS support for a 40-participant pilot stage of the heroin trial undoubtedly marked a watershed for evidence-based policy -- not for legalisation. There is no reason to believe that a heroin trial would have led inevitably to drug legalisation. After all, Britain has permitted medically prescribed heroin for more than 70 years while retaining a similar illicit drug policy to the one in Australia. Legalisation, if it means indiscriminate provision of all classes and quantities of currently illicit drugs, defies common sense, will always remain a political impossibility and would contravene Australia's international treaty commitments. The arguments for a heroin trial are as compelling now as they were before the prime ministerial intervention. As Justice Wood pointed out, "Without such a trial . . . its efficacy or otherwise will never be known. Until attempted, it is very difficult to move forward or to consider alternative strategies".15 The heroin trial was needed, and is still needed, as a circuit-breaker to move Australia from policies based on arbitrary historical decisions to a firm foundation on evidence. As far as the heroin trial is concerned, "the fat lady has not yet sung". Alex D Wodak Director, Alcohol and Drug Service St Vincent's Hospital, Sydney, NSW Short J, Hawes R, Kerin J. Heroin trials not on says Howard. The Australian 1997 Aug 20: 1. Flynn SE. The transnational drug challenge and the new world order. Washington, DC: The Center for Strategic and International Studies, 1993. Bammer G, Douglas RM. The ACT heroin trial proposal: an overview. Med J Aust 1996; 164: 690-692. Cockburn M. Nation's voters divided over ACT drug trial. Sydney Morning Herald 1997 Aug 19: 6. Kassirer JP. Federal foolishness and marijuana. New Engl J Med 1997; 336: 366-367. Australian Parliamentary Group for Drug Law Reform. Australian Drug Law Reform Foundation. Drug lore: the questioning of our current drug law. Canberra: The Foundation, 1997. Hall W, Darke S. Trends in opiate overdose deaths in Australia, 1979-1995. National Drug and Alcohol Research Centre technical report No. 49. Sydney: The Centre, 1997. Collins DJ, Lapsley HM. Social costs of drug abuse in Australia. National Drug Strategy Research Monograph No. 30. Canberra: Commonwealth Department of Community Services and Health, 1991. Report by the Parliamentary Joint Committee on the National Crime Authority. "Drugs, crime and society". Canberra: AGPS, 1989. Review of methadone treatment in Australia. Final report. October 1995. Canberra: Commonwealth Department of Human Services and Health, 1995. Ward J, Mattick R, Hall W. Key issues in methadone maintenance treatment. Sydney: New South Wales University Press, 1992. Swift W, Darke S, Hall W, Popple G. Who's who? A report on the characteristics of clients seen at We Help Ourselves 1985-1991. National Drug and Alcohol Research Centre technical report No. 14. Sydney: The Centre, 1993. Drug and Alcohol Directorate. NSW methadone programme annual statistical report, 1995-1996. Sydney: NSW Health Department, 1997. Uchtenhagen A, Gutzwiller F, Dobler-Mikola A. Programme for a medical prescription of narcotics. Summary of the synthesis report. Berne: Swiss Federal Office of Public Health, 1997. Wood JRT. Royal commission into the New South Wales police service. Final report. Sydney: The Government of the State of New South Wales, 1997: 228. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Alex D Wodak

Visual impairment: a correctable global problem For many in developing countries, treatment may be as simple, and as difficult to obtain, as spectacles MJA 1997; 167: 351-352 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1997 Preventable blindness is one of our most tragic and wasteful global problems, restricting the employment and life prospects of otherwise healthy people, and placing unnecessary strain on families and social welfare systems. Blindness and uncorrected low vision affect every aspect of the social and economic welfare of people and countries -- they impede learning in children and may prevent adults finding employment, in turn adding to the burden on welfare resources. Although it may be relatively simple to correct a visual defect, vision restoration is often not a priority in countries where major life-threatening illnesses are common health care problems. The most wasteful problem in vision restoration is the lack of refraction and spectacles for those who need them Over the past few years, great advances have been made in this area by the alliance of non-government organisations (such as the Partnership Committee of Nongovernmental Organizations), government agencies, private organisations, the World Health Organization, and the World Bank Development Agency. Programs have now been put in place to tackle blindness and visual rehabilitation in a systematic, cost-effective way. Typical of one such effort is the Nepal Prevention and Control of Blindness Project. The high prevalence of cataract blindness in Nepal sparked development of a program to replace cataracts with intraocular lenses. The combination of overseas experts to provide surgical expertise, training, planning and coordination, together with low-cost intraocular lenses from the Fred Hollows Foundation manufacturing facility in Katmandu, have dramatically reduced cataract blindness in Nepal (Dr Ram Prasad Pokhrel, President, Asia-Pacific Academy of Ophthalmology, personal communication). The problem: However, in many areas, such as the Indian subcontinent, it is extremely hard to keep pace with eyecare needs because of rapid population growth, maldistribution of ophthalmic personnel and the difficulty in recompensing ophthalmologists for dealing with the massive backlog of cataract blindness, the major type of preventable blindness today.1 In Asia, the number of eyecare practitioners (all professions, including ophthalmologists, optometrists and opticians) is only 12 per million population, and in Africa it is only three per million, and even worse in many rural areas.1 Ratios are slightly better in the Middle East (47), South America (88) and Eastern Europe (108). In contrast, the ratio of eyecare practitioners per million population in developed countries ranges from 151 (Western Europe), to 245 (Pacific region), 262 (North America) and 444 (Japan).1 The lack of practitioners and services is the main reason for the high prevalence of blindness and other vision problems in many developing countries. The prevalence of blindness in Africa is 1.4% of the population, seven times greater than in developed countries, while in the Middle East it is 1.2%.1 However, about 90% of the vision problems in the world today are treatable or preventable (see Figure). The intervention of a trained eyecare professional can stop disease progression, correct defects or restore sight by surgery. Figure: Major causes of visual impairment worldwide1 (figures refer to millions of people). The most wasteful, and certainly the most common, problem in vision restoration is the lack of refraction and spectacles for those who need them. Most of those with impaired vision worldwide simply require correction of refractive errors, but for many in developing countries this is either not available or inadequate. Even presbyopia becomes a debilitating condition for the aged. The lack of vision care services was highlighted by the recent estimate that half the children in blind institutions in Africa were there because they had never been refracted (Dr Allen Foster, International Centre for Eye Health, Institute of Ophthalmology, London, personal communication). In fact, they were found to be reading Braille by seeing the dots up close rather than by feeling them! Low vision is less known in the community as a cause of debilitation compared with blindness, and funding for its alleviation is more difficult to obtain. However, international agencies are increasingly emphasising the need for commitment to this area. Institutional low vision clinics, which can provide low vision aids (such as magnifiers and telescopes), as well as refraction and spectacles when appropriate, need to be established throughout the developing world, especially in Africa. These could meet local needs by harnessing the skills and knowledge of experts in this area. What needs to be done? Crucial to improving eyecare in developing countries is the provision of well balanced eyecare teams that can effectively deliver quality care. A current model of such a community eyecare team, used by the L V Prasad Eye Institute in Hyderabad, India, provides one ophthalmologist, four optometrists, eight eyecare workers, eight ophthalmic assistants, and 16 ophthalmic nurses per 500 000 people. The number of trained eyecare practitioners in developing countries must be increased. To this end, the World Health Organization has set regional targets for ophthalmologists and optometrists.2 While making practitioners available on a part-time or temporary basis in outreach clinics is an important immediate measure for improving eyecare, long term improvement requires that they be permanently available to the community. To achieve this level of practitioner availability, high quality training programs must be established to produce new eyecare practitioners and enhance the knowledge and skills of existing practitioners. These programs should include continuing professional education to ensure that practitioners are kept up-to-date with the latest techniques and equipment. Infrastructure to support these training programs must be established which includes local institutions, associations, industry and service groups. It is also important that practitioners be widely distributed throughout the countryside. In many developing countries, most practitioners work in the capital cities rather than rural areas. Another essential strategy is the education of eyecare educators. Teaching teachers and providing them with educational resources will ensure the continuation and development of eyecare education in developing countries. These educational initiatives will help improve delivery of eyecare to the population, not only in the form of initial diagnosis and treatment, but in ongoing patient support. Ultimately, education is the means to prevent blindness worldwide. Brien A Holden Professor and Director, Cooperative Research Centre for Eye Research and Technology, University of New South Wales, Sydney, NSW Gullapalli N Rao Director, L V Prasad Eye Institute, Hyderabad, India President, Asia-Pacific Division of the International Agency for Prevention of Blindness Kylie M Knox Manager, Cooperative Research Centre for Eye Research and Technology University of New South Wales, Sydney, NSW Sylvie M Sulaiman Director of Education, International Association of Contact Lens Educators Delegate to the WHO Partnership Committee of Nongovernmental Organizations for Prevention of Blindness International Association of Contact Lens Educators. IACLE demographics report, 1995. Sydney: IACLE, 1996. Partnership Committee of International Non-Governmental Organizations dedicated to the Prevention of Blindness and the Education and Rehabilitation of the Blind. World Health Organization global initiatives plan for prevention of blindness. Geneva: WHO, 1997. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Brien A Holden · Gullapalli N Rao · Kylie M Knox · Sylvie M Sulaiman

Mifepristone (RU486) and abortion A safe, effective and acceptable alternative to surgery MJA 1997; 167: 292-293 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1997 There is overwhelming evidence that the provision of safe and accessible induced abortion is a major factor in preserving the reproductive health of women, but 24% of the world's population live in countries where abortion is not legally permitted. Abortion in these countries can involve spells and incantations, ingestion of herbs or manipulations, such as introducing sticks or disinfectants into the uterine cavity. Such methods vary from being harmless, but ineffectual, to highly lethal, and it is not surprising that 99% of maternal deaths from abortion occur in countries where the more dangerous of these practices are common.1 In Australia, where abortion is widely available and publicly funded, service providers have a duty to ensure that, as with any other legally available medical procedure, the methods used are safe, effective and acceptable. It has been estimated one in three Australian women will seek an induced abortion during their reproductive lifetime. Abortion can be achieved either surgically or medically. Surgical procedures include uterine evacuation via the vagina, and vacuum aspiration is now used to perform over 98% of all first-trimester abortions,2 providing the benchmark against which newer techniques must be assessed. In countries where abortion is legal and supervised by a trained practitioner, vacuum aspiration is very safe and effective. Maternal death occurs in only one in 100000 cases, serious morbidity in less than 1% of cases, and minor morbidity (including psychological disturbances) in 10% of cases. Severe haemorrhage, infective complications and genital tract trauma account for 85% of all major complications. Minor morbidity most often includes prolonged uterine bleeding, retained products of conception, or uterovaginal infection.2,3 It has been estimated that at current rates of abortion one in three Australian women will seek an induced abortion during their reproductive lifetime.4 As 70% of all women who undergo abortion intend to have children in the future, even a small increase in the risk of adverse future reproductive outcomes would have a major impact. Well-controlled, prospective cohort studies suggest that there is no increased risk of complications (including miscarriage and preterm delivery) during future pregnancies after a single abortion by vacuum aspiration, but there are fewer data on multiple vacuum aspiration abortions.5 In 1978 the World Health Organization recommended research into the "development of a non-surgical method of abortion, non-toxic to the woman and non-teratogenic in an effective dosage, reliably producing complete expulsion of the products of conception, suitable for application in a non-clinical setting and economically accessible to women in all countries". Methods of medical induction of abortion include prostaglandins used alone (such as misoprostol, which is available on the Australian Schedule of Pharmaceutical Benefits for other indications, and widely used in other countries for inducing abortion) and, more recently, the antiprogesterones.6 Progesterone is vital for the support of the developing embryo, and the antagonism of this hormone has been tested clinically by inhibiting its production and by direct blockade of progesterone receptors. Drugs such as epostane and trilostane act indirectly by inhibiting the conversion of the precursor, pregnenolone, into progesterone. However, these drugs have been overshadowed by the development of mifepristone, which blocks the action of progesterone at the receptor level. Used alone, mifepristone is not an effective abortifacient, but it becomes one when combined with prostaglandin analogues. Mifepristone (200 mg, orally) used with misoprostol (400 mg, orally or vaginally) results in complete abortion (complete expulsion without the need for subsequent surgical uterine evacuation) at rates of over 95%, with 98% of all women able to leave hospital within eight hours of prostaglandin administration. Efficacy declines as gestational age increases, so this method is usually restricted to gestations of less than nine weeks. The process of care and frequency of unpleasant side effects associated with any procedure will affect its acceptability and hence uptake by the community as a whole. The main short term sequelae of medical abortion include pelvic pain, vaginal bleeding and gastrointestinal disturbance, but these are short lived, and most women return to normal daily activity after 24 hours.7 Women are not anaesthetised in any way during medical abortion, but around 50% require analgesia, and the products of conception may be visualised. Despite these apparent drawbacks, the acceptability of medical abortion is high among European and Chinese women.8,9 Australian women, as reported by Mamers and colleagues in this issue of the Journal, also find the process acceptable.10 Women who sought medical abortion in the Australian arm of an international trial sponsored by the World Health Organization were satisfied with the method and most found the associated level of pain acceptable; those who had had previous surgical abortions also found the medical method more acceptable. Reasons given by Australian women for choosing medical abortion included avoidance of anaesthesia and increased autonomy, that medical abortion is more "natural" and emotionally acceptable, and that it is less stressful. Women also seem to have strong preferences for a particular method -- over 90% of the women interviewed in a British trial indicated that they would have been prepared to pay a premium to ensure that they had a choice of abortion method.11 Prospective randomised trials and cohort studies of vacuum aspiration and mifespristone/prostaglandin regimens have compared safety, efficacy, acceptability, psychological outcomes, economic outcomes and long term sequelae of these alternative methods. There seem to be few differences between the alternatives in any of the parameters studied, and indeed medical abortion may be the procedure of choice at very early (less than seven weeks) gestations. In some United Kingdom hospitals, 60% of abortions are now performed medically, and worldwide over one million women have used the regimen.12-14 Mifepristone has other clinical uses. It has been used to shorten the process and reduce analgesia requirements in labour induction in cases of second-trimester and third-trimester abnormal pregnancy or intrauterine fetal death. Medical uterine evacuation in first-trimester miscarriage is also being explored.15 Critics of mifepristone claim that it will make abortion "easier". The meaning of "easier" is often not defined, but could include easier access to safe abortion services, an easier treatment for medical and nursing staff to administer, or easier -- both physically and psychologically -- for the women having abortions. Some claim that this will lead to an overall increase in the frequency of abortion, although there is no evidence to support this assumption. It is clear, however, that mifepristone/prostaglandin regimens offer safe, effective and acceptable alternatives to surgery that will tend to reduce maternal mortality and morbidity in both developed and, more especially, developing nations. Richard C Henshaw Obstetrician and Gynaecologist Queen Elizabeth Hospital, Woodville, SA Mahler H. The safe motherhood initiative: a call to action. Lancet 1987; 1: 668-670. Henshaw RC, Templeton AA. Methods used in first trimester abortion. Curr Obstet Gynaecol 1993; 3: 11-16. Grimes DA, Cates W. Complications from legally induced abortion: a review. Obstet Gynaecol Surv 1979; 34: 177-191. An information paper on termination of pregnancy in Australia. Canberra: National Health and Medical Research Council, 1997. Hogue CJR, Cates W, Tietze C. The effects of induced abortion on subsequent reproduction. Epidemiol Rev 1982; 4: 66-94. Misoprostol and legal medical abortion [editorial]. Lancet 1991; 338: 1241-1242. Henshaw RC, Naji SA, Russell IT, Templeton AA. A comparison of medical abortion (using mifepristone and gemeprost) with surgical vacuum aspiration: efficacy and early medical sequelae. Hum Reprod 1994; 9: 2167-2172. Bachelot A, Cludy L, Spira A. Conditions for choosing between drug induced and surgical abortions. Contraception 1992; 45: 547-549. Tang GW, Lau OW. Further acceptability evaluation of RU486 and ONO 802 as abortifacient agents in a Chinese population. Contraception 1993; 48: 267-276. Mamers PM, Lavelle AL, Evans AJ, et al. Women's satisfaction with medical abortion with RU486. Med J Aust 1997; 167: 316-317. Howie FL, Henshaw RC, Naji SA, Russell IT, Templeton AA. Medical abortion or vacuum aspiration? Two year follow up of a patient preference trial. Br J Obstet Gynaecol 1997; 104: 829-833. Kaunitz AM, Rovira EZ, Grimes DA, Schulz KF. Abortions that fail. Obstet Gynecol 1985; 66: 533-537. Ulmann A, Silvestre L, Chemama L, et al. Medical abortion of early pregnancy with mifepristone (RU486) followed by a prostaglandin analogue. Acta Obstet Gynecol Scand 1992; 71: 278-283. Bird DT. Medical abortion in Britain. Br J Obstet Gynaecol 1994; 101: 367-368. Rodger MW, Baird DT. Pre-treatment with mifepristone (RU486) reduces interval between prostaglandin administration and expulsion in second trimester abortion. Br J Obstet Gynaecol 1990; 97: 41-46. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Richard C Henshaw

Immunisation -- lifting our game GPs must make the most of every vaccination opportunity MJA 1997; 167: 296-297 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1997 Immunisation is a core preventive activity in general practice, with general practitioners (GPs) being the major providers of childhood vaccination in Australia.1,2 The low immunisation coverage rates in Australia are a major public health problem, but one which GPs have ample opportunities to address. On average, children under six years of age attend GPs seven times a year for intercurrent illnesses, providing many vaccination opportunities.3 The National Childhood Immunisation Program, which commenced in 1995, is a coordinated national effort to address the problem of low vaccination coverage. The study by Herceg et al. in this issue of the Journal shows some encouraging trends in GPs' vaccination performance after the first two years of this Program.4 More GPs are now giving multiple vaccines at the same visit, injecting in the most appropriate site, and not inappropriately postponing vaccination if a child has a mild upper respiratory tract infection, or is taking antibiotics or using inhaled cortico steroids. However, few GPs reported consistently providing opportunistic vaccination. This is partly due to barriers inherent in the present system. GPs need better record systems to alert them to which children are due for vaccination, a greater commitment to providing opportunistic vaccination, as well as more flexible schedules so that they have the time to offer vaccination during family consultations. More GPs are now giving multiple vaccines at the same visit, injecting in the most appropriate site, and not inappropriately postponing vaccination To help overcome some of these barriers to vaccination, the Australian Childhood Immunisation Register was established by Federal and State governments in January 1996, as part of the National Childhood Immunisation Program. The Register sends vaccination reminders to parents and collects data on the vaccination status of individuals and the community. GPs, through their local Divisions of General Practice, have begun working in partnership with public health services to follow-up children who are overdue for vaccination. Unfortunately, some underreporting by vaccination providers has resulted in inappropriate reminders to parents and wasted effort in follow-up, but these problems could be overcome by streamlining the somewhat cumbersome reporting method (involving forms sent in batches to the Health Insurance Commission) and encouraging more GPs to install computer systems which report automatically to the Register. In addition, all providers need to be made more aware of the implications of not reporting. GPs' uncertainty about pertussis vaccination, as reported by Herceg et al., is likely to diminish with the introduction of acellular pertussis vaccine to the Australian schedule over the next few months, and the clarification about contra indications to pertussis vaccination which is included in the 1996 immunisation handbook. Herceg et al. emphasise the importance of providing GPs with unequivocal information, as well as practical skills in educating and informing parents. The Federal Government has also announced several initiatives to improve vaccination coverage which involve GPs, including vaccination days, public education programs, education for GPs, and support for projects initiated by Divisions of General Practice to improve immunisation coverage in local areas. An incentive payment through the Better Practice Program for GPs who achieve 90% immunisation coverage rates in their practices5 is another laudable initiative, but in the absence of some system of patient linkage it will be difficult to determine the appropriate denominator for such a calculation. One way to overcome this problem would be for parents to nominate their preferred vaccination provider when they register their child with Medicare (but this would not restrict their subsequent choice of GP for individual consultations). Thus, parents would be free to attend any GP, but one GP would be responsible for follow-up of their children for vaccination. This would also give GPs a clearer picture of which children they were responsible for. There is evidence that, with the aid of this information, GPs can improve vaccination levels even in lower socioeconomic and mobile population groups.6 The responsibility for immunisation coverage is divided between Federal, State and local governments, with multiple levels of administration which differ between States and even within States. These differences are a constant source of confusion for vaccination providers. The Divisions of General Practice are ideally placed to coordinate local vaccination responsibilities, and to address some of the barriers to improved immunisation coverage within existing systems. This may involve local vaccination campaigns, including promotion and outreach services (e.g., providing a mobile vaccination service to areas with poor immunisation coverage), follow-up of children overdue for vaccination, or recruitment of "hard to reach" children from population groups (low socioeconomic status, recently arrived migrants, non-English-speaking) that are traditionally underimmunised. Herceg et al. have shown that GPs' vaccination performance can improve with appropriate information and education. Education about vaccination should be a regular inclusion in GPs' continuing medical education and quality assurance programs organised by the Royal Australian College of General Practitioners and Divisions of General Practice. However, to achieve 95% coverage, educational interventions must be complemented by changes to the systems within which GPs operate, and concerted efforts at the local level, such as establishment of local immunisation coordinating groups involving Area Health Services, local government, Divisions of General Practice and consumer and community groups. The necessary commitment and collaboration between GPs and public health services can be achieved by financial and professional incentives, education and quality assurance. R S Brian Kable Chair, Preventive and Community Medicine Committee Royal Australian College of General Practitioners, Sydney, NSW Mark F Harris Professor of General Practice, University of New South Wales, Sydney, NSW Traynor V, Britt H, Bridges-Webb C, et al. Immunisation in general practice. Results from the Australian Morbidity and Treatment Survey 1990-1991. Aust Family Physician 1996; 25: 355-359. Australian Childhood Immunisation Register. Preliminary data on proportion of immunisations reported by providers. Immunization Quarterly. Canberra: Commonwealth Department of Health and Family Services, April 1997. Australian Bureau of Statistics. National Health Survey 1990. Canberra: ABS, 1990. Herceg A, Johns M, Longbottom H. Changes in general practitioner vaccination procedures. Med J Aust 1997; 167: 299-302. Wooldridge M. Immunise Australia. The Seven Point Plan. Commonwealth Minister for Health 1996. Canberra: Department of Health and Family Services, 1996. Cullen R. Improving childhood immunisation rates in general practice: problems that affect comparison. N Z Med J 1995; 108: 171-172. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Mark F Harris

Counting the costs of early discharge after childbirth Home may not be where the help is . . . MJA 1997; 167: 236-237 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1997 Overmedicalisation of birth has been a frequent criticism of obstetric practice,1 and, in response to this, early-discharge programs have been endorsed by health professionals and users.2 Evaluation of these programs has been largely positive, but has relied on the choice for early discharge being made by the woman rather than being determined by extraneous factors.2,3 One of the more unfortunate consequences of casemix funding has been the promotion of cost-effectiveness at the expense of choice in Australia; 32% of mothers were discharged less than four days after delivery in 1994, compared with 20.2% in 1991.4 Of these, public patients had an average stay of 3.9 days, compared with 5.7 days for private patients.4 Although private hospitals are now also supporting early discharge, this significant difference suggests that when the choice is more open the stay is likely to be longer. We have clear evidence of the need for greater maternal supports. Until now, studies of early discharge have not shown negative outcomes. Unfortunately, the only one with a randomised group5 had a small sample size and, in the evaluation of postnatal depression, did not separate the randomised group from those who chose early discharge. In this issue of the Journal, Hickey et al.6 used more rigorous criteria for the diagnosis of postnatal depression and found that early discharge was associated with an increased risk of developing the disorder. Nearly 10% of women developed postnatal depression over the six-month study period. The findings of Hickey et al. have profound implications. Postnatal depression affects up to 14% of women,7 and has been associated with impaired mother-infant relationships,8 as well as a higher risk of cognitive and behavioural difficulties in children.9,10 The cost of economic rationalism may not be just at the expense of choice but of long-term outcomes. Unfortunately, the study, because of its small sample size, is unable to examine postpartum psychosis. Although postpartum psychosis is less common, affecting 1 in 600 women,11 it poses a life-threatening risk to both infant and mother. As this disorder often presents in the first week after delivery, most patients are diagnosed in hospital. Early discharge places the responsibility of diagnosis and accessing immediate treatment on to the family; this is, at best, stressful for the family and a risk for the mother and child but, at worst, a tragedy. Another concern emanating from the study is that, with the exception of mothers who stayed longer in hospital because they or their infants had complications (and also had a higher rate of depression), those who were discharged early may well represent a needy group. These women were more likely to be multiparous and have risk factors for postpartum depression, including being less educated and reporting poor relationships with their parents. Therefore, they were more likely to need help but less likely to access services and have support available. These women were also more likely to bottlefeed rather than breastfeed, putting their infants at further disadvantage. Multiparity was also associated with early discharge in Australiawide statistics.4 That such a needy group is being discharged early may reflect the obligation that multiparous women feel about returning home quickly to their other children. It may also reflect, more worryingly, the increased pressure for discharge, the belief by some obstetric and administrative staff that multiparous women need less help, and the lack of education regarding the risk factors for postnatal depression. Although adequate community support services may be able to balance the negative aspects of early discharge, these services may not be readily available or accessible. In their study, Hickey et al. did not outline the postnatal services that were available; whatever services may have been available did not appear to be very effective. Cuts to maternal and child health services have significantly reduced their availability to new mothers, other maternal supports are patchy, psychiatric services are directed to the seriously mentally ill, and child protective services are stretched and able only to supervise the most severe cases. Struggling depressed mothers are often undiagnosed and unsupported, which leaves their children at long-term risk. More research that considers ramifications beyond the presenting problem (which often in medicine, and more often in psychiatry, is not the principal problem) is urgently needed. We have, in the study by Hickey et al., clear evidence of the need for greater maternal supports. Changes to health delivery in the past five years have been marked; we must evaluate their effects urgently if we are to make an impact on the continuing service changes. Postnatal depression may present across many medical specialties and may be recognised and managed by a variety of health professionals. Given its high prevalence and significant ramifications for future generations, it is an area of health delivery in which we must unite, rather than be divided by proponents of demedicalisation of birthing or economic rationalism. It is critical in an era placing emphasis on evidence-based medicine that evidence from studies such as this become incorporated into the feedback loop to influence service provision in appropriate directions. If patterns of health care delivery add to morbidity, then the prescription "first not to harm" is negated. Medical specialists have an obligation to hear the requests of women and manage birth with better communication and awareness of postnatal psychological morbidity, which must be treated early and aggressively. Prevention in health care management is surely an even more appropriate option. Politicians have an obligation to respond to the evidence, both through further research funding for this important area and by appropriate changes in health care delivery. Anne E Buist Associate Professor of Psychiatry Austin and Repatriation Medical Centre, Melbourne, VIC Having a baby in Victoria: final report of the ministerial review of birthing services 1990. Melbourne: Health Department of Victoria, 1990: 10-59, 112-126. Kenny P, King M, Cameron S, Shiell A. Satisfaction with postnatal care -- the choice of home or hospital. Midwifery 1993; 9: 146-153. Lemmer CM. Early discharge: outcomes of primiparas and their infants. J Obstet Gynecol Neonatal Nurs 1987; 16: 230-236. Australian Institute of Health & Welfare, National Perinatal Statistic Unit. Australia's mothers & babies 1994. Sydney: AIHW, 1997. Barnett I, McCarthy M. Patient preference and postnatal hospital stay. J Obstet Gynaecol 1982; 3: 43-47. Hickey AR, Boyce PM, Ellwood D, Morris-Yates AD. Early discharge and risk for postnatal depression. Med J Aust 1997; 167: 244-247. Dennerstein L, Lehert P, Riphagen F. Postpartum depression -- risk factors. J Psychosom Obstet Gynaecol 1989; 10: 53-65. Field T. Infants of depressed mothers. Dev Psychopath 1992; 4: 49-66. Coghill SR, Caplan HL, Alexander H, et al. Impact of maternal depression in cognitive development of young children. BMJ 1986; 292: 1165-1167. Wrate RM, Roony AC, Thomas PF. Postnatal depression and child development. Br J Psychiatry 1985; 146: 622-627. Kendell RE, Chalmers JC, Platz C. Epidemiology of puerperal psychosis. Br J Psychiatry 1987; 150: 662-673. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Anne E Buist

Patient preference and prostate cancer screening Fully informed men should be free to exercise their personal preference regarding screening MJA 1997; 167: 240-241 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - ©MJA1997 Every year in Australia it is estimated that more than 2500 men die of disseminated prostate cancer and many more suffer the consequences of advanced metastatic disease.1 In New South Wales in 1994, the chance of men in the age group 0-74 years developing clinically apparent prostate cancer was 13.2% (2908 new prostate cancer cases were reported in men aged 45-74 years).2 However, because of ageing of the Australian population (many men live beyond 74 years of age) the lifetime risk is actually considerably higher. The use of prostate specific antigen (PSA) screening for early detection of prostate cancer has been the subject of considerable debate. The screening may be of the general population, or limited screening of "at risk" populations, or, finally, case finding, with the screening being part of a routine medical check-up. Currently, for all three types of screening there are no randomised trials to determine whether PSA screening does more good than harm, or the converse. In particular, there is little evidence to support general population screening.3 In the current climate of uncertainty, it is mandatory to include the patient in any screening decision. What is the stance of national professional bodies in the face of this uncertainty? The American Cancer Society recommends annual PSA testing starting at age 50 for men with average risk for prostate cancer.4 Their guidelines, however, are not recommendations for public programs of mass screening, but are intended to help individual doctors and patients select the best early detection protocol for their personal needs. The American Urological Association also recommends annual screening with both digital rectal examination and PSA for men aged 50-70 years.5 On the other hand, the US Preventive Services Task Force recommends against screening,6 and in Europe the consensus is that widespread population screening cannot be recommended as a public health policy at present.7 What are the recommendations in Australia? The Australian Cancer Society8 and the Australian Health Technology Advisory Committee3 recommend against screening.4 The Urological Society of Australasia's current position is to recommend against population screening of asymptomatic men. However, they recommend that asymptomatic men aged 50-70 years (or between 40 and 70 years with a positive family history of the disease) who wish to be tested should be able to do so after appropriate counselling. They suggest that it is up to individual doctors to decide whether to advocate screening for a man not requesting it.9 What are the arguments for and against screening? Those in favour of screening argue that even small tumours will eventually progress to metastatic disease if the patient lives long enough.10 In addition, most cancers detected by PSA-based screening are largely cancers expected from their volume and histological grade to progress.11 There is also strong evidence to suggest that disease confined to the prostate is curable.12 Furthermore, a recent population study with long term follow-up of almost 60 000 patients with clinically localised prostate cancer provided evidence that treatment in moderate and poorly differentiated tumours is superior to observation alone.13 Finally, PSA will detect organ-confined disease, and therefore potentially curable cancer, more frequently than digital rectal examination alone.11 Critics of screening contend that the sensitivity and specificity of PSA screening are too low to make it an ideal screening test. Furthermore, only one cancer will be found for every three men having a biopsy after a PSA-positive test result.11 This leaves a proportion of patients with the stress of being PSA positive and biopsy negative, until it is ultimately discovered whether the PSA test result is a false positive or the biopsy result a false negative. Furthermore, the potential for slow non-life-threatening growth of untreated prostate cancer, particularly in the older age group, means that more men will die with prostate cancer than of it, not to mention the morbidity and mortality associated with the biopsy and the treatment.14 In this climate of uncertainty what are our general practitioners (GPs) doing? The Royal Australian College of General Practitioners recommends against screening.15 However, in a recent questionnaire survey of New Zealand GPs, most indicated that they currently screen at least some men aged 50 or more by digital rectal examination or PSA regardless of beliefs about test efficacy.16 This is probably explained by GPs' direct clinical responsibility and their greater concern with their patients' individual needs rather than with recommendations of public health and professional bodies. What then is the community perspective? In this issue of the Journal, Ward et al. address the subject of male awareness of prostate cancer.17 In a randomly selected group of 340 men aged between 40 and 80, they showed that 22% of those aged 50 or more had been screened for prostate cancer within the previous 12 months. They also found that the men in this population overestimated their lifetime risk of developing and dying of prostate cancer. This is no doubt due in part to the widespread incidence of the disease, as well as a general fear of cancer and raised awareness resulting from increased media coverage. From a public health viewpoint, the significant cost of prostate cancer screening would need to be offset by pos sible cost savings from an eventual mortality rate decrease. From an individual viewpoint, the detection of an asymptomatic organ-confined cancer (case finding) may be of substantial benefit. While the international medical community remain divided on this issue, and there is evidence for and against case finding, we believe that each man must participate in the screening decision and decide for himself. This decision is complex and must be made with full knowledge of the risks of contracting and dying from prostate cancer. The decision will be affected by the man's age and general health, and his particular risk category for developing prostate cancer. The opinions of his general practitioner and even the wishes of his spouse will affect his decision. He must be aware of the potential side effects of diagnosis and treatment, and understand that, in conservatively managed patients, if hormone therapy fails there is no further reliably effective treatment. Ward et al. have shown that screening is occurring in the community, and they argue that accurate information is not being received by the community at large. They recommend that public health initiatives to discourage prostate cancer screening should focus particularly on men with bothersome urinary symptoms and those who worry about prostate cancer.17 While we agree that public education is essential, we believe this must neither discourage nor encourage screening by case finding, but rather give accurate, unbiased information to all men. The information must be balanced, as it has now been shown in several studies that patient preference regarding screening and treatment is greatly affected by this information.18 In the current climate of uncertainty, it is mandatory to include the patient in any screening decision. This is the recommendation of the Australian Health Technology Advisory Committee3 and the Urological Society of Australasia.9 When fully informed, men should be free to exercise personal preference regarding prostate cancer screening. Phillip D Stricker Urologist, St Vincent's Clinic, Sydney, NSW David R Eisinger Urologist, Concord Hospital, Sydney, NSW Australian Bureau of Statistics. Causes of death, Australian, 1994. Canberra: ABS, 1995. (Catalogue No. 3303.0.) Coates MS, Armstrong BK. Cancer in New South Wales. Incidence and mortality, 1994. Sydney, NSW Cancer Council, June 1997. Australian Health Technology Advisory Committee. Prostate cancer screening. Canberra: AGPS, 1996. Mettlin CJ, Jones GW, Avarette H, et al. Defining and updating the American Cancer Society guidelines for the cancer related checkup; prostate and endometrial cancer. CA Cancer J Clin 1993; 43: 42-46. American Urological Association Policy Statement on early detection of prostate cancer. Am Urol Assoc Today 1994; 7: 16. US Preventive Services Task Force. Screening for prostate cancer. Guide to clinical preventive services. 2nd ed. Baltimore, Md: Williams & Wilkins, 1996: 119-134. Flemish Advisory Committee on Cancer Prevention, Belgium. Report of the consensus workshop on screening and global strategy for prostate cancer. Denis LJ, Murphy GP, Schroder FH, editors. Cancer 1995; 75: 1187-1207. Australian Cancer Society. Prostate cancer screening: guidelines for health professionals. Cancer Forum 1995; 19: 47-50. Urological Society of Australasia. Prostate screening, a personal choice: surgeons. Media release, 27 August, 1996. Hugosson J, Aus E, Bergdahl D, et al. Prostate cancer mortality in patients surviving more than 10 years after diagnosis. J Urol 1995; 154: 2115-2117. Catalona WJ, Richie HP, Ahmann FR, et al. Comparison of digital rectal examination and serum PSA in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men. J Urol 1994; 151: 1283-1290. Walsh PC, Partin AW, Epstein JI. Cancer control and quality of life following anatomical radical retropubic prostatectomy: results at 10 years. J Urol 1994; 152: 1831-1836. Lu-Yao GL, Yao Siu-Long. Population-based study of longterm survival in patients with clinically localised prostate cancer. Lancet 1997; 349: 906-910. Hirst GHL, Ward JE, Del Mar CB. Screening for prostate cancer: the case against. Med J Aust 1996; 164: 285-288. Royal Australian College of General Practitioners. Preventive and Community Medicine Committee. Kable B, chair. Guidelines for preventive activities in general practice. 3rd ed. Sydney: RACGP, Oct 1996. Morris J, McNoe B, Adam H. Screening for prostate cancer: what do general practitioners think? N Z Med J 1997; 110: 178-182. Ward JE, Hughes AM, Hirst GHL, Winchester L. Men's estimates of prostate cancer and self-reported rates of screening. Med J Aust 1997; 167: 250-253. Flood AB, Wennberg JE, Nease RF Jr, et al. The importance of patient preference in the decision to screen for prostate cancer. J Gen Intern Med 1996; 11: 342-349. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Phillip D Stricker · David R Eisinger

Doctors and healthcare reform To influence their own destiny, doctors need to participate in the design and management of healthcare reforms that are targeting value for money MJA 1997; 167: 184-185 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - Register to be notified of new articles by e-mail - - ©MJA1997 Healthcare systems all over the world are undergoing substantial change as governments look for ways to constrain what appear to be inexorable cost increases while simultaneously searching for ways to increase value for money. Change is never easy, but the more that individuals participate in planning and implementing change, the more comfortable they feel with these changes. In the past, doctors probably felt they had a significant influence over their immediate work environment. However, this is changing, and, as Perkins et al. report in this issue of the Journal, there is a low level of congruence between the personal goals of individual medical specialists and organisational goals.1 Importantly, the medical specialists are less enthusiastic about their work since the introduction of healthcare system changes that involved resource restrictions and splitting the roles of purchasers and providers (although Perkins et al. did not control for other variables, such as salaries and promotion). the medical profession needs to recognise the legitimacy of funders' and purchasers' concerns about cost increases and value for money While Perkins et al. did not address differences in responses in relation to individual specialists' organisational roles, they did find that specialists in the United Kingdom reported a greater influence on management than their Australian and New Zealand counterparts; this may reflect the greater role for United Kingdom specialists as clinical managers. The study sample in New South Wales (whence the Australian sample was drawn) consisted mainly of visiting medical staff from one Area Health Service, and previous research has shown that visiting specialists identify less with an organisation than physicians who have adopted a managerial role, such as divisional directors.2 Of interest, in terms of health service reform, New South Wales was in a period of relative health policy stability at the time of the survey; nevertheless, the specialists reported decreased enthusiasm for their work. Perkins et al. show that medical specialists would like to influence the "management" of their healthcare organisations, but they have been unsuccessful at this, either because management is unwilling to be influenced, or the attempts at influence are ineffective. At the hospital level, attempts to ensure a greater clinician role in management may involve, as Perkins et al. and their respondents point out, a heavy but rewarding workload. Strategies to enhance clinician influence on policy directions in the wider environment are more difficult to devise. Managed care is the current "bogey" of the medical profession: the profession's current strategy is to run what the health insurance funds deride as a "managed scare" campaign. Governmental and funder concerns about the costs of care and about value for money keep managed care on the agenda in Australia, and political campaigns will not make these concerns disappear. What is needed is a more sophisticated response -- one that addresses the concerns of funders in a way that does not increase feelings of alienation in doctors. With such a response, the medical profession might unpack the many contemporary meanings of managed care and differentiate those elements which have some benefit (e.g., providing feedback to doctors about comparative practice matters) from those which would have a deleterious impact on the Australian health care system (e.g., imposing outdated or rigid treatment protocols). Any policy alternative to managed care must address the need to improve technical efficiency and value for money (technical and allocative efficiency) in the healthcare sector. The key way to address hospital technical efficiency issues is through casemix funding, paying hospitals on the basis of benchmark performance rather than on the basis of history or political influence. Increasing value for money relies on changing the behaviours of providers through funding and education strategies. The 1997 Budget strategy of limiting additions to the Medicare Schedule to cost-effective interventions is a step in the right direction. Providers will also need assistance in implementing best-practice approaches to care -- this can be done through the introduction of local guidelines to influence behaviour. Local guidelines should not be seen as idiosyncratic approaches based on the conventional wisdom of local providers, but rather should be based on the best available evidence,3,4 building on nationally established guidelines where these exist.5 Local guidelines can be supplemented by care paths or clinical pathways to reduce provider variation and lower costs. Care paths also have the benefit of defining appropriate practice and providing a framework for evaluation. The alternative to managed care thus requires a twofold approach: Improve the technical efficiency of healthcare provision; and Encourage and provide incentives for the adoption of local guidelines to influence practice patterns, to ensure effective and efficient care. Unfortunately, local strategies for behaviour change seem to have had limited success.6,7 Even when professional organisations support guidelines for cost-effective care, such guidelines cannot always be implemented, for reasons such as the strongly held beliefs of individual doctors in maintaining their own professional autonomy.8 However, local norms can influence practice,9 through peer pressure and systematic quality assessment processes. In addition, information given to doctors about resource consumption for specific conditions seems to play a part in reducing hospital costs,10 by, for instance, providing feedback to referring physicians about the costs and benefits of ordering particular diagnostic tests. For healthcare providers collectively, it would probably be more politically attractive to be able to influence their own destiny rather than have it determined without their professional involvement. A corollary to this is that the medical profession (and the other health professions) must be given the opportunity to engage in the reform process. To diminish the sense of alienation identified by Perkins et al., the medical profession needs to recognise the legitimacy of funders' and purchasers' concerns about cost increases and value for money. We need to develop strategies that respond to these needs in ways that do not undermine professional values or lead to alienation and loss of morale. Stephen J Duckett Professor of Health Policy; Dean, Faculty of Health Sciences La Trobe University, Melbourne, VIC. Perkins RJ, Petrie KJ, Alley PG, et al. Health services reform: the perceptions of medical specialists in Australia (New South Wales), the United Kindom and New Zealand. Med J Aust 1997; 167: 201-204. Abernethy MA, Stoelwinder JU. Goal orientations and the use of budgeting information: A comparison between physicians and non-physicians in public teaching hospitals. In: Butler JRG, Doessel DP, editors. Proceedings of the Eighth Australian Conference of Health Economists. Sydney: Australian Studies in Health Services Administration, 1987: 67-92. Grimshaw J, Freemantle N, Wallace S, et al. Developing and implementing clinical practice guidelines. Qual Health Care 1995; 4: 55-64. Eccles M, Clapp Z, Grimshaw J, et al. Developing valid guidelines: methodological and procedural issues from the North of England evidence-based guideline development project. Qual Health Care 1996; 5: 44-50. Smallwood RA, Lapsley HM. Clinical practice guidelines: to what end? Med J Aust 1997; 166: 592-595. Eisenberg JM. Doctors' decisions and the cost of medical care. Ann Arbor: Health Administration Press, 1986. Mittman BS, Siu AL. Changing provider behavior: Applying research on outcomes and effectiveness in health care. In: Shortell SM, Reinhardt UE, editors. Improving health policy and management: nine critical research issues for the 1990s. Ann Arbor: Health Administration Press, 1992: 195-226. Rappolt SG. Clinical guidelines and the fate of medical autonomy in Ontario. Soc Sci Med 1997; 44: 977-987. Westert GP. Variation in use of hospital care: an empirical and theoretical analysis of differences in the duration of hospital stay. Assen/Maastricht: Van Gorcum, 1992. Conrad D, Wickizer T, Maynard C, et al. Managing care, incentives and information: An exploratory look inside the "Black Box" of hospital efficiency. Health Serv Res 1996; 31: 235-259. To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Stephen J Duckett

Antibiotic use or misuse? The public, as well as prescribers, need education about appropriate antibiotic use MJA 1997; 167: 116-117 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - ©MJA1997 Compared with similar developed countries, Australia has a high rate of antibiotic use. This is made clear in this issue of the Journal by McManus et al.,1 who show that retail sales of oral antibiotics in Australia in 1994 were about 25 defined daily doses (DDDs) per 1000 population/day, compared with 24 in the United States, 16 in the United Kingdom and 11 in West Germany. The reasons for these differences are less clear. Indeed, they seem paradoxical, as Australia has most of the conventional prescribing controls in place -- a strict regulatory process for evaluating new drugs, the tightly controlled Pharmaceutical Benefits Scheme (PBS), and prescription-only availability. Australia also has a strong tradition of promoting appropriate prescribing in medical schools, through publications such as Antibiotic guidelines2 and through education of medical and pharmacy practitioners. The MJA has been an educational leader in this area, publishing articles and editorials on rational drug use,3,4 antibiotic guidelines5 and antibiotic prescribing interventions in both hospitals6,7 and general practice.8 Cynics often blame the high rate of antibiotic use on the pharmaceutical industry and its intensive promotional activities. Yet the industry is also bound by the regulatory environment, its own code of ethics, and the very powerful effects of the PBS on market forces. The PBS has ensured that drugs in Australia are among the cheapest in the Western world. But, has it ensured that we use antibiotics wisely? The climate is now right to educate the public about infections and when antibiotics might not help. Antibiotics are a valuable resource that is easily squandered. They are unique in being specifically designed to have no action on the host. This can make them attractive to both prescriber and patient, as they can be taken "just in case" the infection is bacterial. However, adverse reactions are still a risk. In addition, bacteria have the ability to mutate to or acquire resistance at rates sufficient to reduce or negate antibiotic usefulness within one to two decades.9,10 Unnecessary prescribing adds to the selective pressure for antibiotic resistance. This leads in turn to increased costs to the community because of the need for more expensive, broader-spectrum agents, extra visits to medical practitioners, and further prescriptions or hospitalisations for antibiotic failures. Broader-spectrum agents generate further resistance, leading steadily to multidrug resistance. Eliminating unnecessary antibiotic use cannot stop resistance emerging, but can reduce its frequency and prolong the useful life of the older, cheaper antibiotics. It is widely believed among Australian microbiology and infectious diseases practitioners that their colleagues often misuse antibiotics. This view is reinforced by results presented by McManus et al., from the Therapeutics Resource and Educational Network for Doctors (TREND) project of the Royal Australian College of General Practitioners. These show widespread use of antibiotics for respiratory tract infections, which are mostly caused by viruses. Australians are unlikely to suffer more bacterial infections or superinfections than their counterparts in other developed countries. More likely, the long history of unnecessary prescribing has built up a community belief that antibiotics are needed for most infections. We have also learnt that information about adverse reactions has only a modest impact on prescribers. For example, publicity about serious adverse reactions to trimethoprim- sulfamethoxazole, flucloxacillin and amoxycillin-clavulanic acid, through means such as the Drug reactions advisory committee bulletin, letters to general practitioners and via the PBS, had minimal effects on prescribing volumes. Subsequent regulatory interventions by the Therapeutics Goods Administration and the PBS had variable results. Flucloxacillin use declined about 30% between 1994 and 1995, and adverse hepatic reactions declined by 50%. In contrast, over the same period use of amoxycillin-clavulanic acid rose by about 10%, and adverse hepatic reactions by 15%.11 We have spent the past decade haranguing prescribers without the expected dividends. However, they continue to be handicapped by the lack of rapid diagnostic tests for common infections to determine need for an antibiotic before prescribing. Thus, it may well be time to switch our attention from the supply to the demand side -- patients must be empowered with basic knowledge about infections. Last year saw the first small step, with the introduction of National Medicines Week, focusing on antibiotics. Soon after, the public began to take notice of emerging resistance and the impact of indiscriminate antibiotic use, largely through the "doomsday" and "superbug" scenarios promoted by the media with stories about drug-resistant Streptococcus pneumoniae, multidrug-resistant Mycobacterium tuberculosis, vancomycin-resistant enterococci, and, most recently, vancomycin-resistant Staphylococcus aureus. The climate is now right to educate the public about infections and when antibiotics might not help. This will reduce not only antibiotic misuse, but also the number of patient visits to medical practitioners, with major benefits for both the community and government. We need a measured approach to public education. It should be conducted at many levels, including in secondary schools, during patient visits to health professionals and through specifically targeted local and national programs similar to National Medicines Week. On an optimistic note, as McManus et al. show, oral antibiotic use actually declined slightly between 1989 and 1994. We must capitalise on this trend by intensifying efforts to eliminate unnecessary use. Lessons can be learned from the approach to other major public health issues -- a judicious combination of regulation and education is likely to be most successful. A pro-active approach to the regulation of availability, prescribing and access to antibiotics, rather than one that is reactive to the pressures of cost and adverse reactions, will favour rational use. Education is needed for health professionals, at both undergraduate12 and postgraduate level,8,13 and for consumers. Everyone will benefit from a better understanding of the basics of infectious diseases and their management given that infections are the commonest of human ailments. John Turnidge Director, Microbiology and Infectious Diseases Women's and Children's Hospital, Adelaide, SA McManus P, Hammond L, Whicker SD, et al. MJA 1997; 167: 124-127. Victorian Drug Usage Advisory Committee. Antibiotic Guidelines. 9th edition. Melbourne: Victorian Medical Postgraduate Foundation Therapeutics Committee, 1996. Moulds RFW. From knowledge to action: improving drug prescribing. Med J Aust 1996; 165: 299-300. Moulds RFW. Rational therapeutics: the way ahead. Med J Aust 1992; 156: 823-824. McDonald P. Antibiotic guide-lines: do we know where we are? Med J Aust 1989; 150: 610-611. Harvey KJ, Stewart R, Hemming M, et al. Educational antibiotic prescribing. Med J Aust 1986; 145: 28-32. Landgren FT, Harvey KJ, Mashford ML, et al. Changing antibiotic prescribing by educational marketing. Med J Aust 1988; 149: 595-599. DeSantis G, Harvey KJ, Howard D, et al. Improving the quality of antibiotic prescription patterns in general practice. The role of educational intervention. Med J Aust 1994; 160: 502-505. Turnidge J, Nimmo G, Francis G, and the Australian Group on Antimicrobial Resistance. Evolution of resistance in Staphylococcus aureus in Australian teaching hospitals. Med J Aust 1996; 164: 68-71. Collignon PJ, Bell JM, on behalf of the Australian Group on Antimicrobial Resistance (AGAR). Drug-resistant Streptococcus pneumoniae : the beginning of the end for many antibiotics? Med J Aust 1996; 164: 64-67. Adverse Drug Reactions Advisory Committee. Antibiotics of continuing concern. Aust Adverse Drug React Bull 1996; 15: 6-7. Snell BF on behalf of the organising committee of the ASCEPT/CHF Conference. Rational prescribing: the challenge for medical educators. Med J Aust 1992; 156: 352-354. Eckert GM, Ioannides-Demos LL, McLean AJ. Measuring and modifying hospital drug use. Med J Aust 1991; 154: 587-592. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

John Turnidge

Reducing the burden of chronic heart failure It's time to adopt new management strategies MJA 1997; 167: 61-62 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - ©MJA1997 Chronic heart failure (CHF) is a major public health problem.1 The disease is associated with poor prognosis2 and markedly reduced quality of life. Unlike other cardiovascular conditions, it is increasing in incidence and prevalence.1,3 Its management imposes a substantial burden on the health care system, accounting for 1%-2% of total health care costs in industrialised nations.4 About 70% of these costs are related to hospitalisation. Most epidemiological data on heart failure have come from the United States and Europe. In Australia, carefully conducted studies of the incidence, prevalence and hospitalisation rates of CHF have been sadly lacking. Thus, the report by Blyth et al. in this issue of the Journal5 is welcome as it provides us with local data on the impact of CHF in the hospital setting. Their findings confirm the massive burden that heart failure imposes on the patient and the health care system. What can we do to contain or even reverse this situation? Despite therapeutic advances, CHF remains a disease with unacceptably high mortality rates, poor quality of life and massive socioeconomic cost. The current approach to managing heart failure comprises non-pharmacological interventions (sodium restriction, alcohol abstention, exercise), drug therapies and, in selected patients, surgery. Surgery has a limited role: if objective evidence exists of reversible ischaemia and/or hibernating myocardium, coronary artery bypass grafting should be considered. Several new surgical approaches may also be useful as long-term therapy in some patients, including cardiomyoplasty, ventriculectomy and insertion of a left ventricular assist device. Transplantation is an extremely effective therapy, but limited by donor organ availability, and the age and comorbidities of many patients with CHF. Drug therapies have a substantial impact on disease outcomes. Angiotensin-converting enzyme (ACE) inhibitors relieve symptoms, improve quality of life and prolong survival.6,7 Digoxin has no overall effect on mortality,8 but may be of symptomatic benefit in patients receiving ACE inhibitor therapy.9 However, mortality remains high even in CHF patients receiving the best available drug therapy. In the CONSENSUS study of patients with severe heart failure, 12-month mortality was almost 50% despite patients receiving diuretics, digoxin and high doses of ACE inhibitors.7 New drugs are continually being evaluated in CHF. Many provide short-term symptomatic benefit, but at the expense of long-term increases in mortality: these include non-digitalis inotropic agents (milrinone, xamoterol, ibopamine, vesnarinone) and direct-acting vasodilator drugs (flosequinan).10 New drugs that appear to offer symptomatic benefit without adverse mortality outcomes include b -adrenoceptor-blocking agents (specifically, carvedilol) and angiotensin II receptor antagonists (specifically, losartan). Recent studies have suggested prolonged survival in chronic heart failure with both agents.11-12 Despite these therapeutic advances, CHF remains a disease with unacceptably high mortality rates, poor quality of life and massive socioeconomic cost. Effective new management strategies are urgently required. In most patients heart failure is a complex disorder requiring an integrated treatment strategy. Physicians, general practitioners, nurse practitioners, nutritionists, physiotherapists and psychologists need to be drawn together to maximise thera peutic benefits to the patient. One approach has been to establish multidisciplinary clinics where patients have access to dedicated physicians, dietary expertise, literature about the disease, behaviour modification interventions and exercise programs. Patients are encouraged to become active participants in managing their disease. They are asked to weigh themselves regularly, monitor dietary sodium intake, watch closely for signs of fluid accumulation or changing symptoms and to interact frequently by telephone with members of the multidisciplinary team. The nurse practitioner regularly checks on patient status and addresses specific enquiries. This approach brings together the skills of multiple health care providers in an environment of frequent and regular appraisal of the patient. Outcomes from pilot studies of this approach have included reduced dietary salt intake, improved compliance with drug therapies, improved patient well-being, and reduced hospitalisations.13,14 In one study, emergency department visits were reduced by 67% and hospitalisations by 87%.14 This was found to be highly cost-effective. Heart failure remains a major clinical challenge for health care professionals in the 1990s. It is no longer sufficient to manage the hospitalised patient well; the real goal of treatment is to address the health of people with heart failure in the community so that they do not require hospital admission. Henry Krum Associate Professor of Medicine, Clinical Pharmacology Unit Department of Epidemiology and Preventive Medicine, and Department of Medicine Monash University, Alfred Hospital, Melbourne, VIC Garg R, Packer M, Pitt B, Yusuf S. Heart failure in the 1990s: evolution of a major public health problem in cardiovascular medicine. J Am Coll Cardiol 1993; 22 (4 Suppl A): 3A-5A. Franciosa JA, Wilen M, Ziesche S, et al. Survival in men with severe left ventricular failure due to either coronary heart disease or idiopathic dilated cardiomyopathy. Am J Cardiol 1983; 51: 831-836. Schocken DD, Arrieta MI, Leaverton PE. Prevalence in mortality rate of congestive heart failure in the United States. J Am Coll Cardiol 1992; 20: 301-306. McMurray J, Hart W. The economic impact of heart failure on the UK National Health Service . Eur Heart J 1993; 14 Suppl: 133. Blyth FM, Lazarus R, Ross D, et al. Burden and outcomes of hospitalisation for congestive heart failure. Med J Aust 1997: 167; 67-70. SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991; 325: 293-302. CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 1987; 316: 1429-1435. The Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med 1997; 336: 525-533. Packer M, Gheorgiade M, Young JB, et al. Withdrawal of digoxin from patients with chronic heart failure treated with angiotensin converting enzyme inhibitors. N Engl J Med 1993; 329: 1-7. Niebauer J, Coats AJS. Treating chronic heart failure: time to take stock. Lancet 1997; 349: 966-967. Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. N Engl J Med 1996; 334: 1349-1355. Pitt B, Segal R, Martinez FA, et al. Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet 1997; 349: 747-752. Rich MW, Beckham V, Wittenberg C, et al. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med 1995; 333: 1190-1195. West JA, Miller NH, Parker KM, et al. A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization. Am J Cardiol 1997; 79: 58-63. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Henry Krum

Urinary symptoms as men age: the reassurance of an evidence-based approach Medical intervention is not usually necessary for men with uncomplicated lower urinary tract symptoms if quality of life is not affected MJA 1997; 167: 62-63 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Make a comment - - ©MJA1997 A high prevalence of uncomplicated lower urinary tract symptoms (LUTS) in an Australian community-based population is reported in this issue of the Journal, although the authors, Pinnock and Marshall, note that despite these symptoms many men and women do not experience substantive dissatisfaction with their quality of life.1 This study is timely, as it follows the recently launched National Health and Medical Research Council (NHMRC) evidence-based Clinical practice guidelines for the management of uncomplicated lower urinary tract symptoms in men.2 Developed by a multidisciplinary working party, the NHMRC Guidelines and two derivative documents, ". . . is it my prostate Doc?" A guide for general practitioners3 and " To pee . . . or not to pee". A guide for men about their urinary symptoms,4 emphasise the need to assess not only the presence of symptoms but also their nature and the "bother" they cause. The distinction between symptoms alone and their impact on quality of life is an important one. There is strong evidence that uncomplicated urinary symptoms in a man are very unlikely to represent any serious threat to his health. For example, the incidence of unsuspected and clinically significant upper-tract obstruction secondary to lower-tract abnormality in these men is very low (0.8%-2.5%).2 Accordingly, the outcome of interest for men (as typified by Pinnock and Marshall's study) is an improvement in their quality of life as related to urinary symptoms, not avoidance of a serious threat to life itself. Thus, measurement of quality of life becomes the key. Only men themselves can assess how bothered they are by their uncomplicated urinary tract symptoms and how much they subsequently improve. How do we encourage men whose quality of life is severely compromised by their urinary symptoms to consult their medical practitioners? Pinnock and Marshall provide another important finding -- that the prevalence of LUTS is similar in men and women aged 55 or more. The factors responsible for LUTS remain to be fully determined -- while urine outflow obstruction in men and pelvic floor dysfunction in women are possible causes, it is probable that many of the changes are simply age related.2 Unfortunately, the use of terms such as "benign prostatic hyperplasia or hypertrophy" (BPH) and "prostatism" inadvertently imply that enlargement of the prostate is the definitive cause of the symptoms. However, the severity of urinary symptoms does not correlate with the presence of BPH or the degree of prostatic enlargement.2 Accordingly, the acronym "LUTS" is preferable to other terminology,5 as it permits a pragmatic definition of the symptom complex without necessarily implying a full understanding of its underlying pathology.2 When is intervention warranted for uncomplicated LUTS? The strongest predictor of the outcome of intervention for uncomplicated LUTS in men is the degree of "bother" the symptoms cause.6 If a man is not particularly bothered by his symptoms, he can be reassured they are unlikely to represent a health threat and that intervention is unlikely to improve his outcome. If he is moderately or significantly bothered, then medical and surgical interventions are more likely to improve his quality of life. While it has been argued that urodynamic parameters or residual urine volume can predict clinically significant differences in the outcome of surgical treatment, this assertion has not been validated in the literature.2 Pinnock and Marshall found that men with high levels of dissatisfaction with the symptoms did not necessarily complain or seek help. Conversely, a smaller, but still substantial, proportion of men who were "not dissatisfied" with their symptoms did visit their doctor because of these symptoms. These findings present a dual challenge. How do we encourage men whose quality of life is severely compromised by their urinary symptoms to consult their medical practitioners? And, because there is little need for or benefit from treatment of symptoms causing minimal bother, how do doctors reassure most men that medical care is unnecessary? We argue that the most effective means of achieving this balance will be via the dissemination and implementation of the NHMRC Guidelines for consumers and their practitioners.7 Of increasing concern to us is the insistence of detractors of the NHMRC Guidelines that early prostate cancer must be excluded as a cause of LUTS and, accordingly, that men must be fully investigated for this malignancy.8,9 Men with uncomplicated LUTS are at no greater risk of early prostate cancer than are their asymptomatic counterparts.2,10 As the evidence to date for prostate cancer screening does not yet meet rigorous public health criteria,11 we believe that the testing of men with LUTS for early prostate cancer is equally unjustified and has the potential to undermine an evidence-based approach to health care. In our view, prostate-specific antigen testing is ethical only when a man has been fully informed of the facts, uncertainties and consequences.12 The NHMRC Guidelines provide eight specific recommendations for further research to clarify those issues poorly supported by empirical evidence. Two priorities were larger randomised trials of the newer urological interventions (such as prostatic heating) against conventional surgical treatments, and methodological research to develop more robust outcome measures. The need for better research is self-evident, especially as the Guidelines are scheduled for review in two years. In the interim, it is our view that, in the absence of strong evidence supporting particular investigations or specific treatments, responsible guidelines should err on the side of conservatism; they should not support a more interventionist position in anticipation of some as yet unidentified future benefit. Men's health will not improve with an unquestioning acceptance of intervention for its own sake. We need to pursue an evidence-based approach with both confidence and compassion, finding new ways to accelerate rigorous, yet relevant, clinical research in areas of need. Concurrently, we need to share the empirical uncertainties of everyday clinical practice more widely with our patients, their partners, our fellow practitioners, and politicians. Geoffrey H L Hirst Urologist, Mater Hospitals, Brisbane, QLD Jeanette E Ward Associate Professor; Director, Needs Assessment and Health Outcomes Unit Central Sydney Area Health Service, Sydney, NSW Pinnock CB, Marshall VR. Troublesome lower urinary tract symptoms in the community: a prevalence study. Med J Aust 1997; 167: 72-75. National Health and Medical Research Council clinical practice guidelines. The management of uncomplicated lower urinary tract symptoms in men. Canberra: AGPS, 1996. National Health and Medical Research Council ". . . is it my prostate Doc?". A guide for general practitioners. Canberra: AGPS, 1996. National Health and Medical Research Council "To pee . . . or not to pee". A guide for men about their urinary symptoms. Canberra: AGPS, 1996. Abrams P. New words for old: lower urinary tract symptoms for "prostatism" [editorial]. BMJ 1994; 308: 929-930. Wasson JH, Reda DJ, Bruskewitz RC, et al. A comparison of transurethral surgery with watchful waiting for moderate symptoms of benign prostatic hyperplasia. The Veterans Affairs Cooperative Study Group on Transurethral Resection of the Prostate. N Engl J Med 1995; 332: 75-79. Thomson R, Lavender M, Madok R. How to ensure that guidelines are effective. BMJ 1995; 311: 237-242. Royal Australasian College of Surgeons media release: Urological Society of Australasia. Men shouldn't ignore urinary symptoms: urologists. April 9, 1997. Royal Australasian College of Surgeons media release: Urological Society of Australasia. Prostate screening, a personal choice: surgeons. August 27, 1996. Rietbergen JB, Kranse R, Boeken Kruger AE, et al. Additional value of the AUA7 symptom score in prostate cancer (PC) detection. J Urol 1997; 157: 467. Commonwealth Department of Health and Family Services prostate cancer screening. Australian Health Technology Advisory Committee (a standing committee of NHMRC). Canberra: AGPS, 1996. Hirst GH, Ward JE, Del Mar CB. Screening for prostate cancer: the case against. MJA 1996; 164: 285-288. To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Jeanette E Ward

Do all Australian women with breast cancer have access to "best practice" in surgical management? Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia". Breast cancer is the commonest internal malignancy among women in Australia. It is increasing in incidence and is expected to continue to do so.1 However, on a positive note, there have been real advances in diagnosis, treatment and psychosocial care of women with breast cancer, and mortality from breast cancer remains stable and is expected to fall.2 A particular advance was the results of randomised clinical trials in the mid 1980s3 which definitively showed that breast-conserving surgery followed by breast irradiation produced much better cosmetic results than mastectomy, without compromising rates of metastasis or survival. Breast-conserving surgery is now an accepted part of "best practice" treatment for most women with early breast cancer, and the National Health and Medical Research Council (NHMRC) has produced guidelines4 on its use. How can we ensure that "best practice" surgical management is available to all Australian women with breast cancer? There has been concern that breast-conserving surgery may not be available to all Australian women. A Victorian survey found that rates of breast-conserving surgery, despite rising from 23% to 43% between 1986 and 1990, were lower among women in non-metropolitan Victoria than among metropolitan women and for surgeons who treated fewer patients with breast cancer per annum.5 In this issue of the Journal, Craft and colleagues provide national data on patterns of breast cancer surgery. Their survey of Medicare data for 1993 found that breast-conserving surgery was undertaken in 39.9% of women reimbursed for breast cancer surgery, but that frequency varied significantly between rural and urban women (33.9% versus 41.9%) and between States (from 33.8% in Western Australia to 49.2% in South Australia/Northern Territory). Similar variations in frequency of breast-conserving surgery have been seen in the United States.6,7 How can we account for these differences? Craft and colleagues suggest that accessibility of radiotherapy services, which are generally located in or near capital cities, may affect a patient's decision to have breast-conserving surgery, although the Victorian survey suggested this is important in only 8% of cases.5 Furthermore, the rate of breast-conserving surgery in a particular rural Victorian practice between 1992 and 1995 was found to be 68%.8 These results suggest that the individual surgeon's attitude still plays an important part in the decision. In drawing conclusions from this study, its limitations must be considered. Craft and colleagues claim to have identified about 60% of the predicted number of women with breast cancer treated in 1993, but these included only patients treated on a fee-for-service basis and therefore excluded all non-insured patients treated in public hospitals. A consistent difference between public and private patients would limit the significance of the results. The study also found that frequency of breast-conserving surgery decreased significantly with patient age. However, this result may not be accurate as the study selection criteria excluded lumpectomy if it was not accompanied by axillary dissection or radiotherapy. It is suspected that radiotherapy is more likely to be omitted -- often inappropriately -- after breast-conserving surgery in older women, many of whom receive follow-up treatment with tamoxifen alone. Unfortunately, the study provides no information on this. Despite these limitations, the rates of breast-conserving surgery reported by Craft and colleagues are low in comparison with estimates that about 70% of mammographically detected cancers and 50% of clinically detected tumours are suitable for breast conservation.4 For example, rates exceeding 50% are routinely reported in metropolitan centres and higher rates have been reported by individuals (e.g., Tulloh and Goldsworthy8). How can we ensure that "best practice" surgical management is available to all Australian women with breast cancer? In the mid 1990s, public and medical concern led the National Breast Cancer Consensus Conference9 and the House of Representatives Standing Committee on Community Affairs10 to recommend the development of evidence-based clinical practice guidelines. The NHMRC guidelines on management of early breast cancer4 were published in November 1995 and disseminated widely by the National Breast Cancer Centre (NBCC). However, other measures may be needed. The Royal Australasian College of Surgeons (RACS) has recognised the need for ongoing training and continuing education and reaccreditation programs for surgeons. For rural women, a regional multidisciplinary team approach is encouraged, as exemplified in the report of breast cancer management in a Victorian country town, where formal links existed with the oncology unit at a Melbourne hospital.8 current data suggest that the survival of patients with breast cancer is better if they are treated by a specialist who also treats a large number of similar patients More extreme measures, such as passing legislation requiring surgeons to disclose options for the treatment of breast cancer, have been tried in the United States. However, this had only a slight and transient effect on rates of breast-conserving surgery, possibly via increased public awareness through publicity about the new legislation, and rates less than 25% were still reported in the US in 1990.7 It is not yet known how far the strategies already in place have overcome problems such as those identified by Craft and colleagues and satisfied the House of Representatives' goal that "the Australian woman who is faced with dealing with breast cancer, regardless of where she lives and whatever her social and economical background, should have the very best treatment and support available".10 To determine the impact of the NHMRC guidelines, the NBCC commissioned a national survey of patients identified through the State cancer registries before the guideline launch. This survey will capture over 90% of patients and provide information on the reasons for choice of treatment options and on surgeon workloads. This is important as current data suggest that the survival of patients with breast cancer is better if they are treated by a specialist who also treats a large number of similar patients, and who has access to the full range of treatment options in a multidisciplinary setting.4,11 As accurate figures on the pattern of surgical care of women with breast cancer become available, better planning and distribution of resources for educating physicians and surgeons about breast cancer may be possible. This would provide women with a greater variety of treatment options and more involvement in decision-making about their care. If necessary, specific educational programs may also be directed at minority patient groups, such as those of a non-English-speaking background, and subgroups, such as rural patients, elderly patients and the disadvantaged. Best practice in the surgical management of breast cancer has come a long way in the past 20 years, and with increased patient involvement in management decisions and a well-educated multidisciplinary team new treatment advances will rapidly find their way into day-to-day clinical practice. John P Collins Head, Breast Unit, Royal Women's Hospital; and Surgeon, Royal Melbourne Hospital,Melbourne, VIC. Commonwealth Department of Human Services and Health. Better health outcomes for Australians. Canberra: The Department, 1994. Taylor R, Smith D, Hoger A, et al. Breast cancer in NSW. Sydney: Cancer Epidemiology Research Unit, NSW Cancer Council, 1994. Fisher B, Bauer M, Margolese R, et al. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 1985; 312: 665-673. National Health and Medical Research Council. Clinical practice guidelines: the management of early breast cancer. Canberra: NHMRC/AGPS, 1995. Hill DJ, White VM, Giles GG, et al. Changes in the investigation and management of primary operable breast cancer in Victoria. Med J Aust 1994; 161: 110-122. Farrow DC, Hunt WC, Samet JM. Geographic variation in the treatment of localised breast cancer. N Engl J Med 1992; 326: 1097-1101. Nattinger AB, Hoffmann RG, Shapiro R, et al. The effect of legislative requirements on the use of breast-conserving surgery. N Engl J Med 1996; 335: 1035-1040. Tulloh BR, Goldsworthy ME. Breast cancer management: a rural perspective. Med J Aust 1997: 166; 26-29. Breast cancer consensus report. Med J Aust 1994; 161 Suppl 7: S1-S16. House of Representatives Standing Committee on Community Affairs. Report on the management and treatment of breast cancer in Australia. Canberra: AGPS, 1995. Sainsbury R, Howard B, Rider L, et al. Influence of clinician workload and patterns of treatment on surviving from breast cancer. Lancet 1995; 345: 1265-1270.

John P Collins

Alternative medicine: an expanding health industry As many Australians are using alternative medicines, it is essential for doctors to ask their patients about such use MJA 1997; 166: 516-517 This article has been cited in Easthope G, et al. Acupuncture in Australian general practice: practitioner characteristics. MJA 1998; 169: 197-200. Rey JM, Walter G. Hypericum perforatum (St John's wort) in depression: pest or blessing? MJA 1998; 169: 583-586. ©MJA1997 What form of therapy is used by at least 50% of Australian patients, costs them more than $900 million a year and is increasingly being supported by health insurance funds? Is it antibiotics, prescribed at 15.1% of all general practice encounters1 and targeted by the Pharmaceutical Benefits Branch of the Department of Health and Family Services as overused? No. Is it non-steroidal anti-inflammatory drugs, which are subject to prescribing restrictions, and are taken by an estimated minimum of 630 000 Australians at any one time (Peter McManus, Secretary, Drug Utilisation Sub-Committee, 1997, personal communication)? No. The form of therapy is something not included in the medical curriculum and rarely considered by most medical practitioners -- described by various terms, it is collectively referred to as "alternative medicine". If 50% of Australians are using alternative treatments each year, it is essential that doctors recognise this fact A South Australian survey of more than 3000 people aged 15 or older found that 48.5% used at least one non-medically prescribed alternative medication annually (excluding calcium, iron and medically prescribed vitamins), and 20.3% of those in the survey had visited at least one alternative practitioner during the year.2 Extrapolated to the Australian population, the overall out-of-pocket costs were almost three times the patient contributions for all classes of pharmaceutical drugs purchased during 1992-1993.2 Our own smaller survey of the use of alternative medicine by people attending a Sydney teaching hospital emergency department revealed remarkably similar results in a predominantly white middle-class population.3 It is perhaps not surprising to learn of the high usage of alternative therapies in children4 and adults5 with cancer, or in people with chronic rheumatoid arthritis.6 However, the high usage in generally "healthy" populations cannot be attributed to desperation about an incurable disease or to reliance on traditional remedies by certain ethnic groups. Other reasons given in our study (apart from consultations for specific conditions) for consulting alternative therapists were to "feel better", "clean up the system", or other, general, reasons. In both the Sydney and the South Australian surveys, consumers of alternative medicine were more likely to be female, better educated and employed.2,3 If these statistics are of concern to the medical profession, then the profession should be even more disturbed to learn that fewer than 50 per cent of both our study population3 and parents of children with cancer4 had informed their doctors of their use of alternative therapies -- yet many were simultaneously taking prescribed medications for the same indications. The startling usage figures are for therapies for which there is, in most cases, no evidence of efficacy beyond "traditional use". Moreover, there are numerous documented problems with the safety of alternative preparations -- their content is uncontrolled, and hence very variable;7 they may be adulterated, as with the Chinese medicines for arthritis that contain corticosteroids;8 and the substances themselves may be intrinsically toxic.9 In Australia, there have been reports of acute hepatitis due to ingestion of chaparral,10 and deaths caused by anaphylactic reactions to royal jelly11 (as summarised by Drew and Myers in this issue of the Journal). The popular perception that alternative medicines are harmless may be true of many preparations, but the more extensive their use, the greater the potential for toxicity. What is being done about this situation? Should more controls be introduced? Prescribed drugs go through an extensive and exhaustive evaluation of their efficacy and safety, but this is not the case for most alternative medicines. Under the Therapeutic Goods Act 1989 (Cwlth) they can be "listed" for a small fee, without evaluation, provided that no specific claim is made for efficacy and there is no available evidence of problems with quality or safety. More than 4500 "herbal" preparations are on this list. Those substances which have been registered as a result of a full evaluation of safety and efficacy may be counted on the fingers of one hand. It is unlikely that the Government will increase its vigilance. The recent review of the Therapeutic Goods Administration (TGA) included the investigation of "approval processes for alternative medicines with a view to ensuring any inappropriate existing impediments are removed."12 The final report has been submitted and, while some recommendations have not been accepted, it is hard to see how these medicines can be any less restricted than they are at present. In his media release in response to the recent TGA review, Senator Christopher Ellison (Parliamentary Secretary to the Federal Minister for Health and Family Services) stated that, with a new range of initiatives, "the Federal Government has ensured that patients can have confidence that their [alternative] medicines will work in the way they are intended to". It is difficult to see how this can be the case when in the same document he states that the approval processes of the TGA should not prevent people obtaining alternative medicines "where the intrinsic safety of the product is not in doubt but the therapeutic effectiveness is unproven". These products should be scientifically assessed so that patients do not unwittingly delay their own access to proven effective therapy. We believe it is up to doctors and other health professionals to address the situation as a matter of urgency. In our survey, the main reasons given for not telling medical practitioners about the use of alternative therapies were the perception that doctors would probably reject the therapies, and a belief that individuals were "in charge of their own health". If 50% of Australians are using alternative treatments each year, it is essential that doctors recognise this fact and be prepared to discuss such use with their patients in a non- judgemental manner. As a minimum step, questions about alternative treatments must be included as a routine part of history-taking. Eliciting the reasons for their use might indicate where conventional medicine is perceived to be failing, and allow supportive discussion with patients. In addition, any unusual or unexplained symptom or sign should raise the possibility of an adverse reaction to, or interaction with, an alternative medication, and if there is a suggestive temporal association the event should be reported to the Australian Adverse Drug Reactions Advisory Committee (Commonwealth Department of Health and Family Services). We need to acknowledge what is happening in the community. It has been suggested that the normal doctor-patient encounter lacks "time, empathy, personalisation, expectation of a cure in chronic disease states, counselling and a general emphasis on health rather than disease".2 While this is not always the case, it is time for us to recognise that a complementary system for trying to achieve a state of well-being exists in Australia and is widely used by our patients. We cannot ignore it and should record and collect objective data about its use. Gillian M Shenfield Clinical Professor in Clinical Pharmacology Philip A Atkin Research Associate in Clinical Pharmacology Sean S Kristoffersen Honours Student, Department of Clinical Pharmacology, Royal North Shore Hospital, Sydney, NSW. Bridges-Webb C, Britt H, Miles DA, et al. Morbidity and treatment in general practice in Australia 1990-1991. Med J Aust 1992; 157 (suppl): 1S-56S. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Kristoffersen SS, Atkin PA, Shenfield GM. Uptake of alternative medicine [letter]. Lancet 1996; 347: 972. Sawyer MG, Gannon AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Begbie SD, Kerestes ZL, Bell DR. Patterns of alternative medicine use by cancer patients. Med J Aust 1996; 165: 545-548. Kestin M, Miller L, Littlejohn G, Wahlqvist M. The use of unproven remedies for rheumatoid arthritis in Australia. Med J Aust 1985; 143: 516-518. Myers SP, Smith AJ. Cardioprotection and garlic. Lancet 1997; 349: 131-132. Huxtable RJ. The harmful potential of herbal and other plant products. Drug Saf 1990; 5: 126-136. Pillans PI. Toxicity of herbal products. NZ Med J 1995; 108: 469-470. Smith BC, Desmond PV. Acute hepatitis induced by ingestion of the herbal medication chaparral. Aust N Z J Med 1993; 23: 526. Harmless herbals? ADRAC Bull 1993; 12: 11. KPMG Management Consulting. Review of Therapeutic Goods Administration on behalf of the Department of Health and Family Services. Canberra: AGPS, Jan 1997 p2. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Gillian M Shenfield · Philip A Atkin · Sean S Kristoffersen