Ethics

Major depression and refusal of life-sustaining medical treatment in the elderly Stuart C Hooper, Kevin J Vaughan, Christopher C Tennant and Janette M Perz MJA 1996; 165: 416-419 Abstract - Introduction - Methods - Patients and assessment - Follow-up - Statistical analyses - Results - Patients - Intensity of depression - Desire for life-sustaining treatment - Discussion - Acknowledgements - References - Authors' details Abstract Objective: To examine the effect of improvement or recovery from major depression in elderly patients on their desire for life-sustaining treatments. Design: Prospective case survey. Setting: Psychogeriatric Service of Hornsby Ku-ring-gai Hospital & Community Health Services and Ryde Hospital & Community Health Services (a community-based service serving an urban population with over 29 000 elderly people). Subjects: All patients referred with major depression (diagnosed by DSM-IV criteria) and no significant cognitive impairment between October 1994 and January 1995. Outcome measures: Number of life-sustaining treatments desired before and after treatment of depression in two hypothetical acute life-threatening illnesses (one with a good and the other with an uncertain prognosis), and intensity of depression on the Geriatric Depression Scale (GDS). Results: 22 subjects completed both stages of the study. Initial depression was severe in five, moderate in 16 and mild in one. GDS scores decreased in 18 subjects after treatment. Mean number of life-sustaining treatments desired by these patients increased significantly from 4.0 to 6.1 (out of seven possible treatments) in the "good prognosis" illness and from 6.4 to to 9.6 (out of 14) overall. The increase in the "uncertain prognosis" illness (2.3 to 3.4) was not significant. Conclusions: Moderate or severe major depression in the elderly is associated with a high degree of refusal of life-sustaining treatments. Treatment of the depression leads to increased acceptance of these treatments, particularly if prognosis is good. MJA 1996; 165: 416-419 Introduction Decisions about withdrawing or withholding life-sustaining medical treatments have become problematic in recent decades. Dramatic advances in medical technology enable many severely ill patients to remain alive, yet the decision to prolong life is tempered by the finite nature of resources, economic rationalism and the patient's quality of life. In the United States, it is estimated that decisions to limit medical treatment are made for about 70% of patients who die in hospital.1 In many cases, this is due to patient refusal of further medical treatment and is part of the strong shift towards respecting patients' autonomy and right to self-determination. In all Australian States, there is a common-law right for competent patients to refuse medical treatment, including life-sustaining treatment. In Victoria, South Australia and the Northern Territory, this right has received statutory recognition. In these States, legislation also permits competent individuals over 18 years to make advance directives ("living wills") specifying that in the event of a terminal illness the individual does not wish to be subjected to extraordinary life-prolonging measures.2 However, the potential influence of depressive illness on patients' refusal of life-sustaining treatment is often neglected. In the elderly (who are disproportionately represented among those who have life-sustaining treatment withheld or withdrawn), depression is often not recognised by primary care physicians.3-7 Misdiagnosis is especially likely in the elderly if symptoms are atypical (e.g., cognitive deficits [pseudo dementia], somatisation or anxiety). Further, with depression impairments in decision-making may be under-recognised, as the cognitive aspects of competence (which are emphasised by doctors and courts) may remain intact, while more subtle abilities (such as the ability to assign realistic values or meanings to the risks and benefits of prospective treatments)8,9 may be impaired. Depressed patients may undervalue potential positive outcomes and predict negative outcomes.9 These "affective" aspects of clinical competence are generally not considered as important as the "cognitive" aspects and can be more difficult to detect.10 The negative outlook disappears after recovery from depression, suggesting that it is specific to the illness phase and not a trait of depression-prone individuals.11,12 Case reports have highlighted patients who have initially refused, but later accepted, life-sustaining treatment after recovery from depression.9,15-18 Longitudinal studies of male Veterans Administration patients in the United States found that desire for life-sustaining treatment was not increased by recovery from major depression of mild to moderate severity,13,14 but was significantly increased if the major depression was severe.14 However, the extent to which results of these case reports and longitudinal studies can be generalised is uncertain. We therefore investigated the effect of recovery from major depression on preferences for life-sustaining treatments in a group of patients referred to an Australian community psychogeriatric service. Methods Our study was approved by the Ethics Committee of the Hornsby Ku-ring-gai Hospital & Community Health Services and Ryde Hospital & Community Health Services. Patients and assessment Subjects for the study were drawn from consecutive patients referred to the Psychogeriatric Service of Hornsby Ku-ring-gai Hospital between October 1994 and January 1995. The Psycho geriatric Service is a community-based service with inpatient facilities, serving an area with over 29 000 elderly people. Inclusion criteria: Diagnosis of DSM-IV major depression,19 made by clinical interview with the consultant psychiatrist and senior psychiatric registrar of the Psychogeriatric Service, according to DSM-IV criteria (Box 1). Severity of depression (mild, moderate, severe) was also assessed clinically with DSM-IV criteria; Mini-Mental State Examination score (MMSE) > 17.20 This was used to screen out patients with significant cognitive impairment; and Informed consent given. Intensity of depression was assessed with the Geriatric Depression Scale (GDS). This is a rating scale (not a diagnostic instrument) that provides a numerical index of intensity of depression and was designed exclusively for use in elderly patients. It contains 30 questions requiring a yes or no answer, which can be either self- or observer-administered. One-week test-retest reliability of 0.85 and criterion validity of 0.82 have been recorded.21,22 Desire for life-sustaining treatment was assessed by a questionnaire adapted from Lee and Ganzini,13 with simplification of the hypothetical scenarios. Patients were asked to "imagine that you developed a sudden life-threatening illness with an uncertain chance of recovery". They were then asked, "Would you want the following procedures should they be needed?". These comprised intravenous fluids with medication, nasogastric tube, blood transfusions, intensive care, kidney dialysis, mechanical ventilatory support, and cardiopulmonary resuscitation. The question was repeated for a similar illness with a good chance of complete recovery. Desire for life-sustaining treatment was quantified by assigning a point for each treatment desired. Follow-up After standard treatment for major depression (including pharmacological agents in all cases and electroconvulsive therapy in two), clinical assessments, GDS and questionnaires were repeated. At least six weeks was allowed before follow-up as the elderly may take longer to respond to antidepressant treatment. Recovery (remission) from major depression was diagnosed clinically at follow-up interview if patients no longer met the DSM-IV criteria for major depression. Statistical analyses The paired t test was used to compare initial and follow-up GDS scores. The Wilcoxon signed-rank test (a non-parametric test) was used to compare initial and follow-up scores for the life-sustaining treatment questionnaire, scoring 1 for any increase and 0 for any decrease and ignoring patients who did not change. The binomial distribution was consulted, with parameters 0.5 and the number of people who changed preferences. Results Patients Of 25 consecutive patients referred with major depression to the Psychogeriatric Service during the study period, 22 were included in the study. Two failed to meet the inclusion criteria (one did not give informed consent and the other did not score sufficiently on the MMSE) and a third died before follow-up. Demographic characteristics of the 22 who completed the study are shown in Box 2. A notable feature was the very high proportion of women in the group (82%). All but four of the patients were new referrals to the service and 10 (46%) were reporting their first depressive disorder. None had a history of previous prolonged psychiatric hospitalisations or previous suicide attempts. Twelve patients (55%) were treated in their homes, eight (36%) were treated predominantly in an inpatient psychiatric unit and two (9%) predominantly in a medical ward. Follow-up after a mean of 88.5 days (SD, 26.3) showed no significant changes in the number of medical illnesses or in demographic variables. Intensity of depression Severity of the depression was classed as moderate for 16 patients (73%), severe for five (23%) and mild for one (5%). Mean GDS score for the group was 24.4 (SD, 3.3) and decreased significantly on follow-up to 16.7 (SD, 8.0) ( P < 0.0005). Individual GDS scores decreased ("improved") in 18 patients, and 12 of these (55% of the total number) were diagnosed clinically as recovered from major depression, according to DSM-IV criteria. Desire for life-sustaining treatment Changes in desire for life-sustaining treatment among those whose depression improved or recovered are shown in Box 3. There were significant increases in the number of interventions desired overall and for the "good prognosis" illness among both the 12 patients who recovered from depression (according to DSM-IV criteria for remission) and the 18 whose GDS scores improved (including six who were not classed as recovered by DSM-IV criteria). There were also increases in the number of interventions desired for the "uncertain prognosis" illness, but the change was significant only in the "recovered" group. Of the 12 patients who recovered, nine had had major depression of moderate severity. The number of interventions desired among these nine also increased significantly overall ( P = 0.05) and for the "good prognosis" illness ( P = 0.04), but not for the "uncertain prognosis" illness. Discussion We found that remission of major depression in the elderly was associated with a significant increase in acceptance of life-sustaining treatments. This increase occurred for both moderate and severe forms of major depression. However, our study has limitations which should caution against drawing firm general conclusions. The main limitations are the relatively small sample size and the possibility of a gender bias caused by the high proportion of female patients. We also do not know the correlation between responses to hypothetical questionnaires and actual decisions when confronted with an "end of life" situation. However, indicating preferences to hypothetical scenarios is similar to executing a "living will" (also, in effect, hypothetical). The hypothetical scenarios examined only acute, not chronic, illnesses, and the findings of this study cannot necessarily be generalised to patients who have coexisting life-threatening medical conditions. In addition, the word "uncertain", used to describe prognosis in one of the scenarios, may have been ambiguous, as all prognoses are uncertain. It was chosen to enable comparison with Lee and Ganzini's studies,13,14 but "poor" or "unfavourable" would have been less ambiguous. A further limitation involved the diagnostic assessments, which did not use structured diagnostic instruments. Our results vary from those of other longitudinal studies.13,14 Ganzini et al.14 found that recovery from major depression was associated with change in preferences for life-sustaining treatments only if the depression was severe. Lee and Ganzini13,14 concluded that, in major depression of mild to moderate severity, "patients should not be discouraged from completing advance treatment directives and that choices by these patients to limit treatment should be respected". However, our finding of a significant increase in the number of life-sustaining treatments desired by nine patients who recovered from major depression of moderate severity suggests that doctors should be cautious about adopting such an approach in the elderly with moderate major depression. Differences between the results of our study and those of Ganzini et al.14 may have been caused by differences between samples and methods. Their sample had a higher proportion of men (81% versus 18% in our study) and their questionnaire about life-sustaining treatments was more complex, possibly affecting subject comprehension and reducing the sensitivity of the instrument. They used DSM-III-R criteria to diagnose major depression, but the differences between these criteria and the DSM-IV criteria that we used are minor. However, neither set of criteria precisely defines the boundaries between mild, moderate and severe forms of major depression, allowing the possibility of diagnostic bias in classifying severity. Further, in analysing their data, Ganzini et al.14 defined a clinically evident increase in preference for medical therapy as an increase in desire for a mean of three or more of the 14 possible interventions. A different cut-off (e.g., two or more of the 14 interventions) would have led to different results. In addition, we allowed a longer time before follow-up than Ganzini et al.14 (mean, 88.5 days versus 24.5 days), and, although we found that degree of recovery measured by GDS was no greater, it is possible that preferences for life-sustaining treatments may take longer to improve than depression. Another possibility is that the longer follow-up period in our study allowed factors other than changes in level of depression to affect preferences. These studies highlight the potential for depression to influence patient desire for life-sustaining treatments, suggesting that clinicians would be wise to take into account patients' mental state when assessing refusal of life-sustaining treatments. If doubt exists about a patient's decisional capacity, or whether major depression is present, psychiatric consultation is indicated. In the absence of an advance directive (completed before the onset of depression), severely depressed patients' wishes to forgo life-sustaining treatments should not be respected until an attempt is made to treat the depression. In contrast, it appears reasonable to respect the wishes of mildly depressed patients, whereas in moderate major depression consensus is lacking. It would be prudent (until further studies clarify this question) to err on the side of preserving life and to treat moderate major depression of moderate severity before respecting a refusal of life-sustaining treatments. Furthermore, patients with moderate or severe major depression who are planning to write advance directives should be encouraged not to do so until their depression has been treated. In our patients whose depression "improved", we found no significant increase in number of life-sustaining treatments desired for an illness with uncertain prognosis. Although the lack of significance may have been due to the small sample size, it suggests that the prognosis of the illness should also be considered in clinical settings. When prognosis is so poor that treatment becomes futile, refusal of life-sustaining treatments should be respected regardless of the presence of major depression, in accord with the ethical and legal principle that doctors are not required to administer futile treatments. The ethical dilemma presented by a depressed patient with dubious decisional capacity who refuses life-sustaining treatments has received little attention. The physician who complies faces the prospect that the patient's decision was biased by the depression and would have reversed on recovery. The physician who does not comply faces the possibility that the request was authentic and the patient's life has been prolonged against his or her wishes. In resolving the dilemma, careful consideration should be given to the severity of the depression, the prognosis of the illness and whether treatment would be deemed futile, and also to any previous directives made by the patient when their decisional capacity was clearly intact. Acknowledgements We acknowledge the generous support of Dr R Russell (Psychogeriatrician, Royal North Shore Hospital), and Dr W Jenneke (Staff Specialist Psychiatrist, Hornsby Ku-ring-gai Hospital). References Greco P, Shulman K, Lavizzo-Mourey R. The patient self-determination Act and the future of advance directives. Ann Intern Med 1991; 115: 639-643. CCH Australia. Death with dignity. Australian Health and Medical Law Reporter. Sydney: CCH Australia Ltd, 1995: paragraph 22-360. Regier D, Hirschfeld R, Goodwin F. The NIMH depression awareness, recognition, treatment program. Am J Psychiatry 1988; 145: 1351-1357. NIH Consensus Development Panel on Depression in Late Life. Diagnosis and treatment of depression in late life. JAMA 1992; 268: 1018-1024. Eisenberg L. Treating depression and anxiety in primary care -- closing the gap between knowledge and practice. N Engl J Med 1992; 16: 1080-1084. Nielson C, Williams T. Depression in ambulatory medical patients: prevalence by self report questionnaire and recognition by nonpsychiatric physicians. Arch Gen Psychiatry 1980; 37: 999-1004. Rapp S, Walsh D, Parisi S. Detecting depression in elderly medical inpatients. J Consult Clin Psychol 1988; 56: 509-513. Appelbaum P, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 1988; 319: 1635-1638. Gutheil T, Bursztajn H. Clinicians' guidelines for assessing and presenting subtle forms of patient incompetence in legal settings. Am J Psychiatry 1986; 143: 1020-1023. Bursztajn HJ, Harding HP, Gutheil TG, Brodsky A. Beyond cognition: the role of disordered affective states in impairing competence to consent to treatment. Bull Am Acad Psychiatry Law 1991; 19: 383-388. Chochinov HM, Wilson KG, Enns M, et al. Desire for death in the terminally ill. Am J Psychiatry 1995; 152: 1185-1191. Wilkinson IM, Blackburn I. Cognitive style in depressed and recovered depressed patients. Br J Clin Psychol 1981; 20: 283-292. Lee M, Ganzini L. The effect of recovery from depression on preferences for life-sustaining therapy in older patients. J Gerontol 1994; 49: M15-M21. Ganzini L, Lee M, Heintz R, et al. The effect of depression treatment on elderly patients' preferences for life-sustaining medical therapy. Am J Psychiatry 1994; 151: 1631-1636. Salzman C. ECT and ethical psychiatry. Am J Psychiatry 1977; 134: 1006-1009. Weitzel W, Purtilo R. Aggressive treatment of geriatric depression: what limits on intervention? Psychiatr Opin 1979; 160: 9-14. Swartz C, Stewart C. Melancholia and orders to restrict resuscitation. Hosp Community Psychiatry 1991; 42: 189-191. Baile F, DiMaggio J, Schapira D. The request for assistance in dying. Cancer 1993; 72: 2786-2791. American Psychiatric Association diagnostic and statistical manual of mental disorders (DSM-IV). 4th ed. Washington DC: APA, 1994. Folstein M, Folstein S, McHugh P. "Mini-Mental State": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12: 189-198. Yesavage J, Brink T, Rose T. Development and validation of a geriatric depression screening scale: a preliminary result. J Psychiatr Res 1983; 17: 37-49. Koenig HG, Meador KG, Cohen HF, Blazer DG. Self-rated depression scales and screening for major depression in older hospitalized patient with medical illness. J Am Geriatr Soc 1988; 36: 699-796. (Received 30 Oct 1995, accepted 3 Jun 1996) Authors' details Department of Mental Health, Hornsby Ku-Ring-Gai Hospital, Sydney, NSW. Stuart C Hooper, FRANZCP, Senior Psychiatric Registrar in Psychogeriatrics; now Consultant Psychiatrist, Sydney, NSW; Kevin J Vaughan, FRANZCP, Staff Specialist. Department of Academic Psychiatry, Royal North Shore Hospital, Sydney, NSW. Christopher C Tennant, FRANZCP, MD, Professor. Department of Psychology, Faculty of Arts and Social Sciences, University of Western Sydney, NSW. Janette M Perz, BA(Hons), Research Psychologist. No reprints will be available. Correspondence: Dr S C Hooper, 11 Clanalpine Street, Eastwood, NSW 2122.

Stuart C Hooper · Kevin J Vaughan · Christoper C Tennant · Janette M Perz

Teaching resuscitation skills using the newly deceased Corinne Ginifer and Anne-Maree Kelly In many hospital emergency departments doctors learn life-saving technical skills on patients who have recently died. This longstanding practice is justified as providing training that cannot be offered in any other way. But can it continue without the informed consent of relatives and the general approval of the public? (MJA 1996; 165: 445-447) For editorial comment, see Ashby Introduction - The overseas experience - The Australasian experience - Ethics - Law - Public debate - References - Authors' details Introduction Patients today are educated, informed and active in decisions concerning their health. Much of the awe and mystery that once surrounded the practices of doctors has been dispelled and some longstanding practices are now being questioned. One such practice is the use of the bodies of newly deceased patients to train staff in specialised emergency procedures, a practice that has been criticised on ethical, religious and legal grounds.1 Aside from these arguments, it may be argued that the practice is outdated, as there are now alternative teaching tools -- but do the alternatives offer the same quality of training? The overseas experience Reports from the United States suggest that the practice is widespread, occurring in up to 39% of hospitals.2 It is considerably more common within certain departments, occurring in 54%-63% of emergency departments and 58% of neonatal critical care programs,2,3 with nearly equal rates in both teaching and non-teaching hospitals.3 Few departments (only 7% in the United States) 3 have a written policy regarding the practice. Less than half of these policies required notification of the next of kin. None the less, reports indicate that in 10% of cases where recently deceased patients were used for this purpose consent was obtained. 2 Endotracheal intubation is the most commonly practised procedure. Other procedures include placement of central venous catheters, surgical venous cutdown, thoracotomy, pericardiocentesis, cricothyrotomy, liver biopsy and intraosseous needle placement. 2 Although there is widespread agreement (even in hospitals that do not teach using recently deceased patients) that the practice has educational value, objections on religious, ethical and legal grounds have been raised in up to 25% of institutions where it is practised. 3 Many members of staff, particularly nurses, find the practice distressing because it appears to conflict with their primary duty of care -- not only to the patient now deceased, but also to the relatives, whom they wish to protect from any further grief. Approaching relatives for consent to perform certain procedures on the recently deceased patient has been an issue much discussed. Many believe that relatives should not be approached for such consent as this would only cause them further distress. 4 However, a Norwegian study found that 58% of people surveyed would allow the body of a close relative to be used for teaching intubation techniques, 5 and a US study found that 39% of families consented to cricothyrotomy on deceased relatives. 6 Success rates for obtaining consent have been reported to be as high as 59% for invasive procedures in adults 7 and 73% for endotracheal intubation in deceased infants. 8 Success in obtaining consent depends upon providing adequate information and explanation to relatives and the opportunity to establish a relationship with the family before the patient's death. 6 The Australasian experience Our search of the Australasian literature ( Medline search using the keywords "newly", "deceased", "teaching" and "resuscitation", limited to the last 10 years) did not find any discussion of this issue, although we thought it likely that the practice is as common in Australia and New Zealand as it is overseas. In April 1995 we surveyed all 55 emergency departments in Australia and New Zealand accredited for training by the Australasian College for Emergency Medicine. The survey asked whether the department used the newly deceased to teach resuscitation skills and, if so, how frequently this practice occurred, which procedures were performed, whether consent was obtained from relatives of the deceased and whether the department had a policy about the practice. Respondents were invited to express their opinions on the legal, social and ethical issues involved. Forty-eight responses were received (response rate, 87%). Twenty-two respondents (46%) indicated that resuscitation skills were taught using the bodies of newly deceased patients in their emergency department. These data are comparable with those reported in the United States. 2,3 Further similarities exist: no department which practised such procedures obtained consent from relatives and only one of the 48 respondents had a written policy governing the practice. The procedures undertaken and their frequency are summarised in the Box. Concerns centred largely on legal and ethical issues, although 73% of respondents believed the practice to be ethical. Ethics The ethics of this practice have been debated in the international literature.1,4,9,10 The central issue is whether the need for training and the benefits resulting from access to the bodies of the recently deceased outweigh any possible harm to individuals and society. The need for highly trained doctors skilled in resuscitation techniques is undisputed. To produce such doctors there must be the means to teach resuscitation skills in a realistic manner. For many years, this was accomplished using recently deceased patients, upon whom an experienced member of staff demonstrated and taught junior members and medical students. Generally, the relatives of the deceased were not informed and, on the whole, only non-invasive procedures were undertaken. Such teaching involved only a few students at a time and was carried out in a sensitive manner with respect for the deceased. It did not present any risk of harm to the deceased while offering an educational opportunity without risks to living patients. However, it may be difficult to justify the use of recently deceased bodies for training if new teaching models and techniques are accepted as adequate alternatives. Sophisticated and realistic manikins can provide practice in endotracheal intubation, venous cannulation, external cardiac compression and so forth. Intubation experience may be gained using patients who are anaesthetised for surgery. Preserved cadavers and anaesthetised animals have also been used to teach various procedural skills. More recently, interactive videodisc instruction has gained recognition as a suitable tool for teaching endotracheal intubation. 3 Whether these alternatives are adequate remains contentious. The British Medical Association and the Royal College of Nursing, while adamantly rejecting the routine use of recently deceased patients for teaching purposes, do accept that it may be acceptable in exceptional circumstances when patients have suffered major trauma resulting in a disturbance to the normal anatomy of the face, neck and upper trunk: "Practising intubation on recently deceased patients who have suffered such injuries affords experience not obtainable in any other way." 11 This position suggests that, in general, the use of recently deceased patients in training can be justified if it is superior to the alternatives available. If so, then perhaps the "harm" we inflict can be justified for the "greater good" to society gained from such access. Would this practice be more acceptable if the consent of relatives was sought? Seeking consent may inflict further grief on those who are already distressed, but this may be the price we pay for the opportunity to access this valuable resource for teaching purposes. Law Laws regarding this practice differ around the world. Burns et al. have reviewed the relevant legislation and test cases in the United States, 2 where there are no state statutes that specifically prohibit the teaching of procedures using recently deceased patients. It has been established by various state courts that the patient's constitutional right to privacy that protects him or her from non-consensual invasion of the body terminates at the time of death. In addition, state courts in Michigan, Georgia and Florida hold that the constitutional rights to privacy and property are personal and cannot be claimed by the next of kin. In contrast, the US Appeals Court for the Sixth Circuit held that the next of kin had a constitutionally protected property interest in the patient's remains. Furthermore, the next of kin could have a legal claim against the hospital for negligent or intentional infliction of emotional distress if procedures were performed on the patient after death without the family's consent. Some countries (including Belgium, France and Israel) have adopted a "presumed consent" policy for organ donation. 2,9,10 This places the onus on the family to raise objection to organ donation; in the absence of specific objection, and with no obligation on the doctor to ask for permission, organ donation may proceed. In these countries the number of kidney transplants is well ahead of many other European countries and no one would doubt the benefits to society. Possibly, the same principle could be applied to the use of newly dead bodies for teaching purposes. What are the Australian laws on these matters? Currently, the coroners and human tissue Acts of the various Australian States do not deal specifically with this issue. Neither do the equivalent New Zealand Acts. There is no doubt that it is unlawful to interfere with coroner's cases, but there is no law preventing the use of bodies to teach minimally invasive and non-invasive procedures during the first few minutes after death in cases that are not required to be reported to the coroner. In Western Australia this may soon change. A new Coroners Act has recently been passed in the Lower House and is now before the Upper House of Parliament. This new Act deals specifically with the use of newly deceased patients for teaching purposes, requiring consent from the coroner together with either prior written permission from the deceased or permission from the senior next of kin in the absence of prior objection from the deceased. Other Australian States may follow suit. It is possible that the performance of such procedures could be considered a trespass under tort law, the principle being that people "should . . . be prevented from touching corpses whether by way of an unauthorized post-mortem examination or for other purposes". 12 This has not been tested in the Australian courts (Dr H Aders, legal adviser to the Medical Defence Union, Sydney, personal communication). Public debate Does the need for training and the benefits arising from access to the bodies of the recently deceased outweigh any possible harm to individuals and society? Progress in the debate has been slow, perhaps because of a reluctance to seek guidance from the community about a practice that has been occurring covertly for many years. References Iserson KV. Postmortem procedures in the emergency department: using the recently dead to practise and teach. J Clin Ethics 1993; 19: 92-98. Burns JP, Reardon FE, Truog RD. Sounding board: Using newly deceased patients to teach resuscitation procedures. N Engl J Med 1994; 331: 1652-1655. Morhaim DK, Heller MB. The practice of teaching endotracheal intubation on recently deceased patients. J Emerg Med 1991; 9: 515-518. Orlowski JP, Kanoti GA, Mehlman MJ. The ethical dilemma of permitting the teaching and perfecting of resuscitation techniques on recently expired patients. J Clin Ethics 1990; 1: 201-205. Brattebo G, Wisborg T. Teaching procedures on the newly dead [letter]. Ann Emerg Med 1995; 26: 242. Olsen J, Spilger S, Windisch T. Feasibility of obtaining family consent for teaching cricothyrotomy on the newly dead in the emergency department. Ann Emerg Med 1995; 25: 660-665. McNamara RM, Monti S, Kelly JJ. Requesting consent for an invasive procedure in newly deceased adults. JAMA 1995; 273: 310-312. Fernandes CMB. Practice of procedures on the newly dead [letter]. Ann Emerg Med 1995; 26: 1. Iserson KV. Law versus life: the ethical imperative to practice and teach using the newly dead emergency department patient. Ann Emerg Med 1995; 25: 91-94. Goldblatt AD. Don't ask, don't tell: practicing minimally invasive resuscitation techniques on the newly dead. Ann Emerg Med 1995; 25: 86-90. Royal College of Nursing. Intubation training: An ethical practice? Nursing Standard 1993; 7: 38-39. Trindade F, Cane P. The law of torts in Australia. 2nd ed. Melbourne: Oxford University Press, 1993. Authors' details Western Hospital, Melbourne, VIC. Corinne Ginifer, MB BS, DA(UK), DipRACOG, Emergency Medicine Registrar; Anne-Maree Kelly, FACEM, Staff Specialist, Emergency Medicine. No reprints will be available. Correspondence: Dr C Ginifer, Emergency Department, Western Hospital, Footscray, VIC 3011.

Corinne Ginnifer · Anne-Maree Kelly

Congenital syphilis: still a reality in 1996 Michael D Humphrey and David L Bradford MJA 1996; 165: 382 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright 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/>". Introduction - What is the true incidence of congenital syphilis in Australia? - Diagnosis - Risk factors for congenital syphilis - Measures to control syphilis - Problems in targeting those at risk - Action plan - Acknowledgements - References - Authors' details - - ©MJA1996 Despite the widespread use of penicillin for more than 50 years, syphilis continues to be a problematic health issue in many parts of the world. In Australia, congenital syphilis is again a significant cause of stillbirth, preterm labour and neonatal disease in some areas (including central and northern Australia). Control mechanisms based on screening, reliable treatment protocols, contact-tracing and adequate follow-up appear to be less effective than they were in the past. It is difficult to discuss such a socially stigmatising disease when it is clear that some community groups are at high risk, and may be offended by and feel disempowered in the face of well-meaning medical debate. If congenital syphilis is to be eradicated, new approaches are required. These include public-awareness campaigns to stress the need for antenatal care in affected communities; involving the community in efforts to prevent syphilis; providing culturally appropriate services; improving notification and surveillance systems; improving the management of pregnant women who present to maternity units without prior booking; and improving the management of syphilis in pregnancy. There is a need to raise awareness that antenatal care is important not only for the mother's health but also for the wellbeing of the baby. (MJA 1996; 165: 382-385) Introduction I n the last decade, much of the world has experienced a marked increase in the incidence of syphilis, with rates in reproductive-age adults the highest since the 1940s. 1 In Australia, notifications of syphilis between 1991 and 1994 varied from 12.2 to 16.0 per 100 000 population. 2 There was wide geographical variance, with reported rates greater than 100 per 100 000 in much of northern Australia; however, all States and Territories were involved (Box 1). The incidence was much higher in females than in males in the 10 to 24 years age group, and rates in Aboriginal people varied from 114 to 913 per 100 000 in different regions. 2 Elsewhere in the world, incidences similar to those in Australia are being reported, with particular emphasis on the high incidence of new and repeated infections in marginalised groups. 1,3-9 In regions where the prevalence of syphilis is high, congenital syphilis is a major preventable cause of perinatal death. 1,8,10,11 In 1994 and 1995, 232 new or repeated infections were notified in women from Cairns and the surrounding region involving Cape York and the Torres Strait (D Brookes, Public Health Nurse, Tropical Public Health Unit, Northern Zone, Queensland Health Department, Cairns, personal communication). Twenty-seven of the 3058 women who gave birth at Cairns Base Hospital during this period had active syphilis complicating their pregnancy (Tropical Public Health Unit, Northern Zone, Queensland Health Department, Cairns [unpublished data]), and eight of the region's 91 perinatal deaths were judged to be due to congenital syphilis in association with inadequate antenatal care (Cairns Base Hospital Perinatal Mortality Committee [unpublished data]). The main features of untreated congenital syphilis during pregnancy are stillbirth (which may be preceded by non-immune hydrops fetalis), preterm labour and intrauterine growth restriction; in the newborn the main features are hepatosplenomegaly, prolonged jaundice, thrombocytopenia, failure to thrive and radiologically visible metaphyseal changes. To prevent congenital syphilis, institutional, administrative and cultural barriers to the successful management of the problem must be overcome. The true incidence of syphilis must be determined, diagnostic procedures improved, the risk factors more readily recognised and control measures re-examined. What is the true incidence of congenital syphilis in Australia? The accurate diagnosis of syphilis depends on the microbiological demonstration of Treponema pallidum . Serological tests provide indirect evidence of infection, and, without clinical assessment, are crude indicators of whether infection is likely to be recent or long-standing. Nevertheless, in many jurisdictions in Australia case reporting of syphilis is dependent on laboratory notification of positive syphilis serology. Thus, notification of syphilis is based on an arbitrary decision as to whether an infection is likely to be recent, as determined by the rapid plasma reagin (RPR) or Venereal Disease Research Laboratories (VDRL) titre. For example, in Queensland the case definition for notification is based on an RPR/VDRL titre of 1 : 8 or more, in association with positive specific treponemal serology. 12 Cases so notified are likely to be in individuals who have a recently acquired infection, and non-notification of lower titres may mean that there is a degree of under-reporting, particularly in the latent phase of the disease. No agreed definition of the criteria for reporting congenital syphilis exists in Australia, and only 13 cases have been reported nationally in the last five years, including two in women over 65 years of age (J Irvine, Surveillance Officer, Communicable Diseases Network of Australia and New Zealand -- National Notifiable Diseases Surveillance System, Canberra, personal communication). Thus, the true incidence of this problem nationwide is unknown. Diagnosis Definitive diagnosis is by trepo nemal-specific tests ( Treponema pallidum haemagglutination antibody [TPHA], fluorescent treponemal antibody [FTA]) when screening non-treponemal serological tests (RPR or VDRL) are positive, as pregnancy, HIV infection and other conditions (such as systemic lupus erythematosus, rheumatoid arthritis, infectious mononucleosis, and many other diseases associated with autoimmune complexes) can be associated with false positive screening reactions, or with difficulties in interpreting results. 13 Care must be taken to ensure that lack of familiarity with the codes used to express the results of syphilis serology does not lead to failure to recognise the disease and, consequently, failure to follow-up. 5 It is necessary to carefully follow-up all babies born to women who have positive serological tests for syphilis, as more than 50% of liveborn affected infants are asymptomatic. Failure to conduct such follow-up may lead to significant long term physical and/or mental handicap. Risk factors for congenital syphilis These risk factors include: Lack of adequate antenatal care; 8 Failure to repeat a serological test for syphilis in the third trimester when it tested negative at first booking; 8 Past history of sexually transmitted disease (STD); 8 Multiple sexual partners; 8 Substance abuse; 8 and Being in a displaced or marginalised population group (indigenous peoples, and people marginalised by chemical dependency, poverty, prostitution). 9 Vertical transmission usually takes place after four months' gestation, so that early antenatal screening and appropriate treatment should prevent most cases. It is clear that, if screening is not performed, the diagnosis is unlikely to be made in a timely fashion. Therefore, major efforts must be made in the future to alter the way we deliver antenatal care so that it is accessible and appropriate to those at high risk. Measures to control syphilis Guidelines for syphilis control, formulated almost 60 years ago in the United States, 14 included the principal elements of public education (including community participation), case-finding, prompt clinical treatment, contact-tracing and routine serological screening (including antenatal screening) of high-risk groups. The implementation of this program in the United States proved to be effective. However, in 1986 the incidence of early syphilis in the United States increased, 15 with a predictable increase in congenital syphilis accompanying this new epidemic. 16 By 1990, at the peak of the epidemic, African Americans accounted for more than 80% of reported cases of early syphilis. 17 A dramatic increase in the availability of "crack" cocaine (accompanied by an increase in the practice of exchanging sex for money and drugs), increasing poverty, disenfranchisement of minorities and urban decay were some of the reasons for this disproportionate incidence of syphilis in black communities in the United States. 17 The efficacy of control programs for sexually transmitted disease, and especially contact-tracing activities, employed to control this outbreak of syphilis in the United States was seriously questioned. 18 In Australia, we have sought to control syphilis by broadly following the same United States guidelines. In the major cities, where syphilis rates today are minimal, this has served us well. However, throughout northern Australia, as well as in northern Victoria, central Australia and northwest New South Wales, the prevalence of syphilis has remained high, despite our best efforts. Allan Brandt (Professor of the History of Medicine and Science, Harvard University), in No Magic Bullet , argues that a biomedical approach (e.g., case-finding, contact-tracing and treatment protocols) is too restrictive, and that social conditions and other variables need to be addressed. 19 While there will always be a place for contact-tracing the immediate partner(s) of index cases -- particularly of pregnant women with syphilis (as a control measure) -- this is less successful in practice than theory would suggest. Various factors, such as the time involved and the patient's embarrassment and reluctance to contribute to the program, make contact tracing difficult to conduct from the urban consulting room. However, in indigenous communities other factors, such as cultural sensitivity about the discussion of sexual issues outside the family or tribal group, beliefs in what constitutes "men's business" and "women's business" and the dilemma of finding health workers of the same sex and tribal group to conduct the tracing, pose additional difficulties. These factors, together with a relative dearth of male indigenous health workers, a rapid turnover of staff and the low priority placed on public health activities, result in often-insurmountable difficulties in implementing contact-tracing. In any case, many diagnoses of syphilis in adults in northern Australia are likely to represent latent rather than currently infectious disease, so th at even highly successful contact-tracing will have a relatively small impact on public health control of the disease. Problems in targeting those at risk A recent editorial in Sexually Transmitted Diseases notes that in the United States "syphilis is a marker for social marginalization" (i.e., the spread of the disease is disproportionate in poor members of minority groups). The authors state that: . . . Underlying the problem of syphilis in the United States, and central to any plans to eliminate it, are the issues of race, racism, and poverty, and our ability to speak frankly and intelligently about these issues. . . . It is from a legitimate fear of the consequences of the social stigma of syphilis that many community advocates prefer not to talk about racial differences in syphilis rates. . . . This hiding of the key fact about syphilis may be making it difficult for concerned persons to mobilise the kind of support needed for effective prevention programs. 1 We believe a "key fact" in Australia is that Aboriginal and Torres Strait Islander populations are disproportionately affected by syphilis, yet it is difficult to talk openly about this for fear of further marginalising or stigmatising indigenous people. This understandable sensitivity has tended to stifle productive debate about how we can best deal with the issue, and has hampered communication between affected communities and health professionals. The continuing high prevalence of syphilis in indigenous communities in Australia is a major threat to the welfare of unborn and newborn children. It is vital that those at most risk can be targeted for the provision of high quality antenatal care (if necessary, through special outreach programs); for retesting in the third trimester or at birth; 20,21 for the development of appropriate treatment protocols; and for contact-tracing that is realistic and achievable. Action plan It seems clear that we need a new approach if syphilis is to be controlled, and if congenital syphilis is to become (as it should be) a tragedy of the past. While accepting that the persistence of infectious syphilis (and the accompanying sporadic cases of congenital syphilis) in indigenous communities in Australia is a complex issue, we suggest some measures that could be considered in addressing the problem ( Box 2). We must find a way to discuss honestly and openly the continuing high prevalence of syphilis in indigenous communities, which is a major threat to the welfare of unborn and newborn children, so that those at most risk can get the most appropriate care. Acknowledgements We wish to thank Ms D Brookes, RN (Public Health Nurse, Tropical Public Health Unit, Northern Zone, Queensland Health Department, Cairns), Dr W J Smith (Cairns District Health Service) and the staff of the Communicable Diseases Network of Australia and New Zealand -- National Notifiable Diseases Surveillance System, Canberra, for their assistance. References St Louis ME, Farley TA, Aral SO. Untangling the persistence of syphilis in the south [editorial]. Sex Transm Dis 1996; 23: 1-4. Hargreaves J, Longbottom H, Myint H, et al. Annual Report of the National Notifiable Diseases Surveillance System, 1994. Commun Dis Intell 1995; 19: 542-574. Garland SM, Kelly VN. Is antenatal screening for syphilis worth while? Med J Aust 1989; 151: 368-372. How JHY, Bowditch JDP. Syphilis in pregnancy: experience from a rural aboriginal community. Aust N Z J Obstet Gynaecol 1994; 34: 383-389. Gurry DL, Porter PA, Evans DTP. Congenital syphilis: when the medium fails to transmit the message. Med J Aust 1993; 159: 121-124. Humphrey MD. Syphilis -- alive and well as a cause of perinatal death [letter]. Med J Aust 1996; 164: 381-382. Mascola L, Pelosi R, Blount JH, et al. Congenital syphilis. Why is it still occurring? JAMA 1984; 252: 1719-1722. Lim CT, Koh MT, Sivanesaratnam V. Early congenital syphilis -- a continuing problem in Malaysia. Med J Malaysia 1995; 50: 131-135. McFarlin BL, Bottoms SF, Dock BS, Isada NB. Epidemic syphilis: maternal factors associated with congenital infection. Am J Obstet Gynecol 1994; 170: 535-540. Duthie SJ, King PA, Yung GLK, Ma HK. Routine serological screening for syphilis during pregnancy -- disposable anachronism or fundamental necessity? Aust N Z J Obstet Gynaecol 1990; 30: 29-31. Klass PE, Brown ER, Pelton SI. The incidence of perinatal syphilis at the Boston City Hospital: a comparison across four decades. Pediatrics 1994; 94: 24-28. McCall B. Surveillance of sexually transmissible disease in Queensland 1988-1993. Commun Dis Intell 1995; 19: 58-68. Nandwani R, Evans DT. Are you sure it's syphilis? A review of false positive serology. Int J STD AIDS 1995; 6: 241-248. Parran T. Shadow on the land. New York: Reynal and Hitchcock, 1937. CDC. Primary and secondary syphilis -- United States, 1981-1990. MMWR Morb Mortal Wkly Rep 1991; 40: 314-315, 321-323. CDC. Surveillance for geographic and secular trends in congenital syphilis -- United States, 1983-1991. MMWR Morb Mortal Wkly Rep 1993; 42 (Suppl 6): 59-71. Nakashima AK, Rolfs RT, Flock ML, et al. Epidemiology of syphilis in the United States, 1941-1993. Sex Transm Dis 1996; 23: 16-23. Andrus JK, Fleming DW, Harger DR, et al. Partner notification: can it control epidemic syphilis? Ann Intern Med 1990; 112: 539-543. Brandt AM. No magic bullet: a social history of venereal disease in the United States since 1880. Expanded edition. New York: Oxford University Press, 1987: 4. Qolohle DC, Hoosen AA, Moodley J, et al. Serological screening for sexually transmitted infections in pregnancy: is there any value in re-screening for HIV and syphilis at the time of delivery? Genitourin Med 1995; 71: 65-67. Opai-tetteh ET, Hoosen AA, Moodley J. Re-screening for syphilis at the time of delivery in areas of high prevalence. S Afr Med J 1993; 83: 725-726. Metropolitan New York City Area Task Force on Syphilis. Report to the New York State Department of Health 1991: 1-16. Ernst AA, Romolo R, Nick T. Emergency department screening for syphilis in pregnant women without prenatal care. Ann Emerg Med 1993; 22: 781-785. Sanchez PJ, McCracken GH Jr, Wendel GD, et al. Molecular analysis of the fetal IgM response to Treponema pallidum antigens: implications for improved sero diagnosis of congenital syphilis. J Infect Dis 1989; 159: 508-517. Quinn TC. Recent advances in diagnosis of sexually transmitted diseases. Sex Transm Dis 1994; 21 (Suppl): S24. Authors details North Queensland Clinical School, The University of Queensland. Michael D Humphrey, FRACOG, Professor of Obstetrics and Gynaecology; and Director of Obstetrics and Gynaecology, Cairns Base Hospital, QLD. Cairns District Health Service, Cairns, QLD. David L Bradford, FACVen, Director of Sexual Health. No reprints will be available. Correspondence: Professor Michael D Humphrey, Department of Obstetrics and Gynaecology, Cairns Base Hospital, PO Box 902, Cairns, QLD 4870. - - To top of article - ©MJA1996 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Michael D Humphrey · David L Bradford

The new genetics: legal and ethical implications for medicine Community discussion and informed guidelines for medical practitioners are needed MJA 1996; 165: 301-303 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright 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 email - - ©MJA1996 The achievements and potential of "the new genetics" were recently described as follows: The human genome has now been completely mapped and by the year 2000, virtually all genes will have been isolated and sequenced . . . The technology exists to allow analysis of all persons for mutations causing single gene disorders, probably very early in pregnancy or using IVF . . . [Next] will be predicting risk of multifactorial, common diseases of later life, including cancer. (Professor Bob Williamson, Director of the Murdoch Institute of Research into Birth Defects. The new genetics -- for good or ill , Dean of Medicine's Lecture Series, University of Melbourne, 1996.) These developments have enormous potential for good. About 8000 currently recognised single gene defects 1 afflict at least 1% of the population, more than half with serious consequences. In addition, links have been increasingly recognised between genetic factors and conditions such as cancer and heart disease. Many people are already affected by genetic testing. However, genetic testing raises important legal and ethical issues that must be investigated and resolved expeditiously. Information and consent: General legal principles dictate that genetic testing should be voluntary and based on appropriate information. The High Court of Australia stated in Rogers v Whitaker that a patient is entitled to be informed of "material risks" of a procedure and that a risk is "material" if "a reasonable person in the patient's position . . . would be likely to attach significance to it". 2,3 A patient having a genetic test should obviously be told the purpose and nature of the test, the implications of a positive result and other diagnostic options. As test results may affect other family members, discussion and counselling need to be wider and to include explanations of the information implicit in the family pedigree, as well as who will be told the results and by whom. If information from medical records or genetic test results is needed from relatives (living or dead), permission should be sought, even if tissue is already available for testing. Although there may be no legal requirement, this respects their autonomy and right to privacy. Prenatal screening: Prenatal screening of pregnant women for genetic abnormalities such as Down's syndrome is now routine in Australia. However, there is a chance of both false positives and false negatives and, even if a genetic abnormality exists, there are no tests for severity of impairment. As termination itself is a subject of debate, testing and termination of pregnancy should remain voluntary, and a woman who chooses not to terminate a pregnancy should not be penalised by health or social welfare providers. Confidentiality and access to information: Genetic information may have serious consequences, not only for patients, but also for their families. Although pretest counselling would encourage most patients to share results with their family, some may refuse permission for disclosure. An amendment to the Australian Medical Association Code of Ethics in February 1996 acknowledged that "Exceptions [to the obligation of confidentiality] may arise where the health of others is at risk . . . ". 4 The law also recognises that it may be lawful to breach confidentiality where there is a serious risk to others (note that the law requires the risk to be "serious"). 5 Thus, it is arguable that a doctor who knows a patient carries a harmful genetic mutation would be justified, both ethically and legally, in advising a relative who could take measures to avoid or minimise disease, or who is about to start a family, to undertake testing for the mutation. Indeed, it may be argued that genetic information is "common" to the family, rather than "belonging to" the individual alone, so that a doctor might be justified in always telling family members that the genetic mutation exists in the family (but not that a particular person has, or does not have, the gene). Of course, even people who have been tested may not wish to know the result. For example, many people do not want to know that they will develop a late-onset illness for which there is no treatment, such as Huntington's disease. Both ethics and law support this; patient autonomy entitles people not to know, just as much as to know. Use of genetic information: Life and disability insurers may require that genetic test results be disclosed for risk classification before cover is granted; currently, they do not initiate genetic tests. The Life, Investment and Superannuation Association of Australia states: "Effective underwriting relies upon an assessment of all factors that impact upon the life to be insured." 6 The Association considers that an applicant for insurance who has information that the insurer does not have (such as genetic test results indicating a high risk of premature death) should not be permitted to "anti-select" against the insurer by taking out a very large insurance policy. Denying insurers genetic information could cause a "shift in the risk profile of people taking out insurance". 6 However, others may be concerned that the "genetically handicapped", who are perhaps in most need of disability cover, will find it unobtainable or very expensive. Perhaps, people seeking genetic tests should be warned that they will have to supply results to an insurer if they apply later for insurance; they may be better advised to obtain insurance before rather than after the test. Employers and government agencies, such as the police, may also seek access to genetic information, so it is essential that it be held securely, with strict controls on its potential applications. How to resolve these issues: In Australia, various recommendations have been made 7-12 or are being considered. The Cancer Genetic Ethics Committee of the Australian Cancer Network and the Anti-Cancer Council of Victoria, chaired by Professor Emeritus Richard Lovell, is currently preparing guidelines for genetic testing in relation to cancer. The Australian Research Council has given a three-year grant for research and report on legal issues related to the Human Genome Project, and many conferences have been held on related issues (e.g., Community and the New Genetics, convened by the Human Genetics Society of Australasia in 1995). However, more thought should be given to developing integrated Australia-wide policies and to involving patients and the general community in decision-making. Traditionally, new medical research has been regulated through ethical guidelines prepared by the National Health and Medical Research Council (NHMRC). Although these do not have the force of law, they are generally observed and are flexible, being readily amended in the light of experience and community opinion. The guidelines being prepared by the broadly based Cancer Genetic Ethics Committee, informed by detailed legal and ethical research, could provide the foundation for NHMRC guidelines and community discussion. It is important to get the ethics right first. If legislation is needed on specific topics, it can be developed later. Loane Skene Associate Professor and Director of Studies, Health and Medical Law, Law School, University of Melbourne, Melbourne, VIC. Max Charlesworth Emeritus Professor of Philosophy, Deakin University, Geelong, VIC. On-line Mendelian Inheritance in Man, OMIM (TM). Baltimore (MD): Center for Medical Genetics, Johns Hopkins University, and National Center for Biotechnology Information, National Library of Medicine, 1996 [cited 1996 Aug 5]. OMIM Statistics. World Wide Web URL: http://www3.ncbi.nlm.nih.gov/omim/ Rogers v Whitaker (1995) 109 ALR 625 at 634. Nuffield Council on Bioethics. Genetic screening: ethical issues. London: the Council, 1993. Australian Medical Association. AMA Code of Ethics. Canberra: AMA, 1996. W v Egdell [1990] 1 All England Reports 835. Life, Investment and Superannuation Association of Australia. Draft policy regarding genetic testing. Sydney: LISA, 1996. Medical Research Ethics Committee of the National Health and Medical Research Council. Report to the NHMRC. Ethical aspects of research on human gene therapy. Canberra: AGPS, 1987. National Health and Medical Research Council. Statement on human experimentation. Supplementary Note 7, Somatic cell gene therapy and other forms of experimental introduction of DNA and RNA into human subjects. Canberra: NHMRC, 1982: 21-22. Medical Research Ethics Committee of the National Health and Medical Research Council. Report to the NHMRC. Guidelines for the use of genetic registers in medical research. Canberra: AGPS, 1991. Victorian Law Reform Commission. Genetic manipulation. Melbourne: the Commission, 1988. Report No 26. House of Representatives Standing Committee on Industry, Science and Technology. Genetic manipulation: the threat or the glory? Canberra: AGPS, 1992. Federal Privacy Commissioner. Privacy implications of genetic testing. Exposure Draft 1995. Sydney: Human Rights and Equal Opportunity Commission. 1996 . - Register to be notified of new articles by email - - To top of article - ©MJA1996 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Loane Skene · Max Charlesworth

The clinical and ethical implications of hepatitis C for organ transplantation in Australia Ian H Kerridge, Peter Saul and Robert G Batey Current Australian policy prohibiting transplantation of organs from hepatitis C-infected donors raises questions about patient autonomy and medical paternalism. MJA 1996; 165: 282-285 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright 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/>". Introduction - HCV infection - Transmission of HCV by organ transplantation - Implications of HCV infection after organ transplantation - Ethical issues - Conclusions - Acknowledgements - References - Authors' details - Register to be notified of new articles by email - - ©MJA1996 Case 1 A 42-year-old man presented to a liver clinic for assessment as he had recently been found to be hepatitis C virus antibody (anti-HCV) positive. Liver function test results had been normal in the two years preceding this appointment, and the patient felt perfectly well. There were no signs of chronic liver disease, and a liver biopsy (undertaken at the patient's request) 12 months earlier had shown minimal inflammatory damage and no fibrosis. One of the main points for discussion at the outpatient clinic was that this patient had been rejected as an organ donor by the transplantation service. He was indignant that his offer of organs was rejected, particularly as he felt that it would be appropriate in the event of his death for his liver to be made available to another HCV-positive patient. He asked for advice as to why HCV-positive patients were unable to donate organs for transplantation. Case 2 A 48-year-old man presented with advanced alcohol-related liver disease and is awaiting liver transplantation. His clinical progress had improved slowly after cessation of alcohol intake but his liver function had deteriorated in the preceding six months. He had been advised that liver transplantation might be required within 12 months but had not yet been placed on the active transplantation list. This patient asked if he could have a liver transplant earlier if he agreed to accept an HCV-antibody positive liver. This request was motivated by his frustration at being unable to work and his awareness that patients with hepatitis C were receiving transplants and apparently doing well. He was advised, that at present, there is a policy banning the use of organs from all HCV-positive donors in Australia. He agreed to abide by these rules but insisted that this issue be investigated further. Introduction D uring the past decade, advances in immunosuppression and transplantation technology have increased the demand for organ transplantation without a corresponding increase in the number of donors. In June 1995, 1869 Australians were on waiting lists for solid-organ transplantation, with a further 1435 awaiting corneal transplants. Waiting-list numbers increased by 17% in the first six months of 1995, while the Australian organ donation rate continued to fall. 1 The relative donor shortage and its impact on both waiting lists and the length of time patients wait for transplantation highlights the importance of efficient and effective organ procurement and use. 2 Viruses which may be transmitted by organ transplantation (such as cytomegalovirus, herpes simplex virus, Epstein-Barr virus, human immunodeficiency virus, hepatitis A virus, hepatitis B virus, hepatitis D virus and human T-cell lymphotropic virus type 1) have become one of the major causes of morbidity and mortality in organ transplant recipients. 3 For this reason, potential organ donors are routinely screened for the presence of viral infection. After the identification of the hepatitis C virus, and the recognition that it may be transmitted by organ transplantation, transplantation organisations have restricted the use of organs from anti-HCV-positive organ donors. 4 There is no international consensus about the use of HCV-positive organs in transplantation. Three recent studies from the United States highlight the variation in policies for the transplantation of organs from HCV-positive donors. Milfred et al. 5 found that, for heart and lung transplantation, 22% of the centres studied would accept organs from anti-HCV-positive donors irrespective of recipient HCV status, 45% would accept such donors only for anti-HCV-positive recipients, 27% would never accept these donors, 2% did not screen donors, and 4% did not have a defined policy. 5 By contrast, studies by Ramos et al. 6 and Schweitzer et al. 7 found that most US transplant centres would not accept organs from anti-HCV-positive donors for renal transplantation. Part of the reason for the lack of consensus is that the consequences of transplantation of organs from anti-HCV donors (including the degree of HCV transmission, the prevalence of liver disease and the impact of HCV infection on survival) remain unclear. 8-11 Furthermore, any guidelines must incorporate ethical considerations relating to resource allocation, prognostic uncertainty, medical paternalism and limitation of patient autonomy. In New South Wales, the Transplant Advisory Committee policy currently excludes transplant of all HCV-positive organs and tissues, including transplant to known HCV-positive recipients. The implications are that one in 50 potential organ donors are lost to the transplant program and that certain individuals therefore lose the right to choose potentially life-sustaining organ transplantation with an organ they know to be infected with HCV. These cases raise questions about the current Australian policy of excluding transplantation of HCV-positive organs and whether this constitutes unjustifiable paternalism. As with many questions of ethics in clinical practice, further understanding depends upon a number of factual issues concerning the transmission of HCV during transplantation and the consequences of HCV infection for the graft recipient. HCV infection HCV infection is now the most frequently reported notifiable disease in Australia. 12 Its true prevalence is unknown, but studies of Australian blood donors demonstrate a prevalence of 0.3%-0.7%. 13,14 Most estimates suggest that there are at least 100 000 cases in Australia. International studies reporting the incidence of HCV in cadaveric organ donors have shown wide variation (1.5%-16.7%), 15-17 probably reflecting both geographical variation in HCV prevalence and the different testing methods used for HCV identification. Second generation enzyme-immunoassays used to detect anti-HCV have a sensitivity and specificity of about 90% and 99%, respectively, resulting in a positive predictive value in Australian blood and organ donors of less than 50%. 18 Confirmatory assays (e.g., radioimmunoblot assay [RIBA-2] and polymerase chain reaction techniques) can provide further evidence of actual HCV infection but may also give false positive or false negative results. 19 Genotyping assays are now available and may prove to be important for prognosis, determining epidemiological research and monitoring response to treatment. Most cases of hepatitis C in Australia can be traced to a history of parenteral exposure through intravenous drug use (50% of cases) 20 or blood products (10%-15% of cases). 21 Since the introduction of routine donor screening for hepatitis C, the risk of transmission by infected blood products has reduced substantially. 22 Accurate information about the natural history of hepatitis C is extremely limited because diagnoses of acute hepatitis are rarely made, serum transaminase levels are poor predictors of liver disease and most studies of long-term outcome are limited to a 10-year follow-up. It is estimated that 50%-80% of infected patients develop chronic hepatitis C and 20%-30% of these will progress to cirrhosis. An unknown number (varying from 10%-75%) will develop hepatocellular carcinoma (HCC). 23 The mean interval between infection and diagnosis of cirrhosis is estimated to be 20 years. The cornerstones of managing hepatitis C virus infection are education about its natural history and counselling to prevent transmission or worsening of the disease (e.g., avoiding the sharing of needles, restricting alcohol intake and practising "safe-sex"). Interferon alfa is available for treatment of chronic HCV under the Pharmaceutical Benefits Scheme but is extremely expensive; the long term response rate after a standard six-month course is approximately 20%-25%. 24 End-stage liver disease in patients with HCV can be managed medically or by liver transplantation. Reinfection of the graft is almost universal. Despite the need for immunosuppressive therapy, the resultant liver disease is generally benign and graft survival in the medium term (up to five years) is equivalent to that of other causes of liver disease requiring transplantation. Hepatitis C is now the most frequent indication for liver transplantation in Australia. 25 Transmission of HCV by organ transplantation There is conflicting evidence about the risk of transmission of HCV with organ transplantation. 26-30 Retrospective studies indicate that hepatitis is evident in approximately 50% of recipients of HCV-antibody-positive kidney transplants. 31 The type of solid organ transplanted (heart, lung, liver or kidney) does not appear to influence the transmission of HCV from an infected donor to a recipient. Recent studies have also demonstrated the transmission of HCV through bone marrow transplantation 32 and bone, ligament and tendon allografts. 33 Given the likely high degree of HCV transmission by organ transplantation, there is considerable interest in the work of Zucker et al., which suggests that washing donated kidneys can remove 99% of the viral burden. It is not known whether this has any significant impact on the transmission of HCV. 34 Implications of HCV infection after organ transplantation There is evidence that liver disease is more frequent in recipients of anti-HCV-positive organs, 35 that immunosuppression may enhance HCV replication 36 and that immunocompromised patients infected with HCV may have a more aggressive course of infection. 37 A number of studies have also shown that, when HCV infection develops after renal transplantation, it will become chronic in approximately 85% of recipients and may progress to cirrhosis. 38 There is also evidence to suggest that HCV infection may increase the risk of rejection and infection; 39,40 however, no study has consistently demonstrated a significantly increased rate of mortality or graft loss in recipients of anti-HCV-positive organs. 41 The effects of HCV infection on transplanted livers in immunocompromised hosts can be partly surmised by examination of HCV-positive patients who receive HCV-negative liver transplants -- early reinfection occurs almost uniformly 42 and may range in severity from asymptomatic viraemia to cirrhosis and hepatic failure. A small number of patients develop fulminant hepatic failure after organ transplantation, but reinfection is usually not clinically significant, producing only mild inflammation. In general, primary infection with HCV and reinfection in a transplanted patient follow a similar course. 43 Growing awareness of the heterogeneous nature of HCV genotypes has led to suggestions that anti-HCV-positive organs could be safely made available for transplantation into anti-HCV-positive recipients. 44 Unfortunately, a number of studies have suggested that patients may become infected with multiple viral genotypes, 45 and there may not be sufficient cross-immunity between different HCV subtypes. 46 Furthermore, there is some evidence to suggest that repeated exposure to the virus may result in repeated bouts of hepatitis. 47,48 Thus, host seropositivity for HCV may provide no absolute assurance that a patient receiving an HCV-positive organ will have less risk of infection and liver disease. In general terms it seems likely that transplant-related infection may follow a similar course to primary infection with hepatitis, 43 but the long term implications of HCV infection after organ transplantation remain unclear. Importantly, the use of interferon alfa for chronic hepatitis C does not appear to increase the risk of graft rejection. 49 Ethical issues With the increasing scarcity of organs, maximum use of donors is essential to realise the full potential of organ transplantation. However, in attempting to meet the health needs of both individuals and society, all attempts must be made to maximise the benefit and minimise the risks of transplantation to the recipient. The high probability of transmitting HCV by organ transplantation and the uncertain long term consequences of HCV infection in immunocompromised hosts have led the Transplantation Advisory Committee to ban the transplant of HCV-positive organs in New South Wales. This policy is clearly medical paternalism; the question is, is it justifiable paternalism? Should informed patients be able to request transplantation of HCV-positive organs, in the light of their own wishes, beliefs and values, or do policies such as these constitute justifiable limits of autonomy? The uncertain risks of HCV may add to the mortality and morbidity associated with organ transplantation, but this is not in itself sufficient reason for preventing patients from choosing an HCV-positive organ. It is well accepted that competent patients may have the right to choose medical interventions which have significant or uncertain side effects, provided they are aware of the nature and likelihood of such complications. This is especially the case when alternative forms of therapy are associated with high rates of morbidity and mortality. For example, young patients with acute myeloid leukaemia will always be offered bone-marrow transplantation, despite its significant risks, because other treatments for this condition have such poor outcomes. This is not to suggest that patient autonomy is, or should be, unrestricted. Patients may not request treatment that is ineffective, that endangers others, or that is judged by health care professionals and, ultimately, by society to be of insufficient value to be allocated scarce health resources. It may well be that current policy should continue for non-life-threatening conditions (such as renal transplantation in chronic renal failure) because of the uncertain long-term consequences of HCV infection and the small number of donor organs that would be gained from relaxing the prohibition on the use of HCV-positive organs. On the other hand, for patients awaiting heart, lung or liver transplantation, the risk of liver disease after organ transplantation from an HCV-positive donor may well be more acceptable than the risk of death or poor quality of life without transplantation. A further difficulty is that, whereas the transplantation of an HCV-positive organ may benefit the individual, this may be to the detriment of the wider community. The use of HCV-positive organs would clearly generate a potential source of preventable infection which may impact significantly on the lives of others (such as sexual partners) and inevitably demand further expensive treatment. The cost of a six-month course of interferon alfa is $3200 and the cost of liver transplantation for end-stage liver disease is $120 000, plus $7000-$10 000 per annum postoperatively. A conservative estimate of the cost of treating a patient with chronic hepatitis C (including hospitalisations) over five years is approximately $100 000. The effects on the present system of waiting-lists of a separate pool of "sub-standard" HCV-positive organs may also become increasingly complicated. Should a patient be able to "jump the queue" to a position higher up the waiting list if they are willing to accept such an organ? Should a patient at the top of the queue have the right to refuse an HCV-infected organ? Should there be a separate list of patients who are eligible only for HCV-infected organs? Conclusions Much of the uncertainty about the significance of hepatitis C infection in organ transplantation will only be resolved by further research. Until then, the obligations suggested by the ethical principles of autonomy, non-maleficence, beneficence and justice suggest a number of alternative approaches to the management of HCV-positive donors, shown in the Box. The decision to transplant an HCV-infected organ remains a complex issue in which benefit must be weighed against harm and individual choice against the wider demands of society and scarce health resources. Ultimately, such issues may only be resolved through an approach based on shared and informed decision-making between doctors and patients, recognising the many clinical and epidemiological uncertainties involved in these circumstances. That there are organ recipients willing to accept HCV-positive organs, but prevented from doing so by current policy, reflects tension between professional guidelines and individual needs or between medical paternalism and patient autonomy. We believe that there are circumstances in which transplantation of HCV-infected organs may be indicated, particularly in the case of life-saving transplantation. Decisions that deny choice to informed, competent patients are the subject of increasing scrutiny by the medical and legal professions and the community at large. If patients who are aware of the risks and complications are to be denied the choice of an HCV-infected organ, such denial must be carefully considered and explicitly justified. Acknowledgements We acknowledge the contributions of Dr Michael Lowe for his editorial assistance and of members of the John Hunter Hospital Clinical Ethics Committee for advice on the formulation of this paper. References Australian Coordinating Committee on Organ Registries and Donation (Gladesville, Sydney, NSW). Newsletter, October 1995 (distributed to all intensive care and renal transplant units). Shiener PA, Mor E, Schwartz ME, Miller CM. Use of hepatitis C-positive donors in liver transplantation. Transplant Proc 1993; 25: 3071. Aswad S, Mendez R, Weingart RG, Mendez R. Expanding organ availability by using hepatitis C antibody-positive donors. Transplant Proc 1993; 25: 2270-2271. Public Health Service inter-agency guidelines for screening donors of blood, plasma, organs, tissues and semen for evidence of hepatitis B and hepatitis C. MMWR Morb Mortal Wkly Rep 1991; 40: 1-17. Milfred SK, Lake KD, Anderson DJ, et al. Practices of cardiothoracic transplant centers regarding hepatitis C seropositive candidates and donors. Transplantation 1994; 57: 568-572. Ramos EL, Kaiske BL, Alexander SR, et al. The evaluation of candidates for renal transplantation: the current practice of US transplant centers. Transplantation 1994; 57: 490-497. Schweitzer EJ, Bartlett ST, Keay S, et al. Impact of hepatitis B or C infection on the practice of kidney transplantation in the United States. Transplant Proc 1993; 25: 1456-1457. Tesi RJ, Waller K, Morgan CJ, et al. Transmission of hepatitits C by kidney transplantation -- the risks. Transplantation 1994; 57: 826-831. Aeder MI, Shield CF, Tegtmeier GE, et al. The incidence and clinical impact of hepatitis C virus (HCV) positive donors in cadaveric transplantation. Transplant Proc 1993; 25: 1469-1471. Diethelm AG, Roth D, Ferguson RM, et al. Transmission of HCV by organ transplantation. N Engl J Med 1992; 326: 410-411. Triolo G, Squiccimarro G, Baldi M, et al. Antibodies to hepatitis C virus in kidney transplantation. Nephron 1992; 61: 276-277. Commonwealth Department of Human Services and Health. Hepatitis C. Commun Dis Intell 1994; 18: 533. Archer GT, Buring ML, Clark B, et al. Prevalence of hepatitis C virus antibodies in Sydney blood donors. Med J Aust 1992; 157: 225-227. McGuinness PH, Bishop GA, Lien A, et al. Detection of serum hepatitis C virus RNA in anti-HCV seropositive (RIBA positive) volunteer blood donors with normal ALT levels. Hepatology 1993; 18: 485-490. Aeder MI, Shield CF, Tegtmeier GE, et al. Incidence and clinical impact of hepatitis C virus-positive donors in cadaveric transplantation. Transplant Proc 1993; 25: 1469-1471. Pereira BJ, Wright RL, Schmid CH, et al. Screening and confirmatory testing of cadaveric organ donors for hepatitis C virus infection: a US National Collaborative Study. Kidney Int 1994; 46: 886-892. Candinas D, Joller-Jemelka HI, Schlumpf R, et al. Hepatitis C RNA prevalence in a Western European organ donor pool and virus transmission by organ transplantation. J Med Microbiol 1994; 41: 220-223. Talley NJ. Internal medicine. Sydney: Maclennan and Petty, 1990: 288. Strasser SI, Desmond PV, Watson KJR, et al. The value of routine hepatitis C PCR in clinical practice. Gastroenterology 1994; 106: A991. Bell J, Batey RG, Farrell GC, et al. Hepatitis C virus in intravenous drug users. Med J Aust 1990; 153: 274-276. Strasser SI, Watson KJR, Lee CS, et al. Risk factors and predictors of outcome in an Australian cohort with hepatitis C infection. Med J Aust 1995; 162: 355-358. Donahue JG, Munoz A, Ness PM, et al. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med 1992; 327: 369-373. Ikeda K, Saitoh S, Koida I, et al. A multivariate analysis of risk factors for hepatocellular carcinogenesis: a prospective observation of 795 patients with viral and alcoholic cirrhosis. Hepatology 1993; 18: 47-53. David GI, Balart LA, Schiff ER, et al. Treatment of chronic hepatitis C with recombinant interferon alfa. A multicentre randomised controlled trial. N Engl J Med 1989; 321: 1501-1506. Ascher NL, Lake JR, Emond K, Roberts J. Liver transplantation for hepatitis C virus related cirrhosis. Hepatology 1994; 20: 245-275. Roth D, Fernandez JA, Babischkin S, et al. Detection of hepatitis C virus infection among cadaver organ donors: evidence for low transmission disease. Ann Intern Med 1992; 117: 470-475. Pereira BJ, Milford EL, Kirkman RL, Levey AS. Transmission of hepatitis C virus by organ transplantation. N Engl J Med 1991; 325: 454-460. Wreghitt TG, Gray JJ, Allain JP, et al. Transmission of hepatitis C virus by organ transplantation in the United Kingdom. J Hepatol 1994; 20: 768-772. Maple PA, McKee T, Desselberger V, Wreghitt TG. Hepatitis C virus infections in transplant patients: serological and virological investigations. J Med Virol 1994; 44: 43-48. McDonnell WM, Lucey MR. Hepatitis C virus transmission during organ transplantation. Hepatology 1993; 17: 162-164. Morales JM, Munoz MA, Castellano G, et al. Impact of hepatitis C in long-functioning renal transplants: a clinicopathological follow-up. Transplant Proc 1993; 25: 1450-1453. Shuhart MC, Myerson D, Childs BH, et al. Marrow transplantation from hepatitis C virus seropositive donors: transmission rate and clinical course. Blood 1994; 84: 3229-3235. Conrad EV, Gretch DR, Obermeyer KR, et al. Transmission of the hepatitis-C virus by tissue transplantation. J Bone Joint Surg Am 1995; 77: 214-224. Zucker K, Cirocco R, Roth D, et al. Depletion of hepatitis C virus from procured kidneys using pulsatile perfusion preservation. Transplantation 1994; 57: 832-840. Weir MR, Kirkman RL, Strom TB, Tilney NL. Liver disease in recipients of long-surviving renal allografts. Kidney Int 1985; 28: 839-844. Chazouilleres O, Kim M, Combs C, et al. Quantitation of hepatitis C virus RNA in liver transplant recipients. Gastroenterology 1994; 106: 994. Pereira BJG, Milford RL, Kirkman RL, et al. Liver disease and HCV infection after transplantation of organs from hepatitis C antibody-positive donors. Transplant Proc 1993; 25: 1458-1459. Huang CC, Lai MK, Lin MW, et al. Transmission of hepatitis C virus by renal transplantation. Transplant Proc 1993; 25: 1474-1475. Roth D, Zucker K, Cirocco R, et al. The impact of hepatitis C virus infection on renal allograft recipients. Kidney Int 1994; 45: 238-244. Fritsche C, Brandes JC, Delaney SR, et al. Hepatitis C is a poor prognostic indicator in black kidney transplant recipients. Transplantation 1993; 55: 1283-1287. Ynares C, Johnson HK, Kerlin T, et al. Impact of pretransplant hepatitis C antibody status upon long-term patient and renal allograft survival -- a 5 and 10-year follow-up. Transplant Proc 1993; 25: 1466-1468. K"nig V, Bauditz J, Neuhaus P, et al. Follow-up of hepatitis C virus (HCV) reinfection in liver allograft recipients. J Hepatol 1991; 13: 540. Wright TL, Ferell L, Donegan E, et al. Impact of hepatitis C viral (HCV) infection on the allograft following liver transplantation. J Hepatol 1991; 14: 51A. Morales JM, Andres A, Campistol JM. Hepatitis C virus and organ transplantation. N Engl J Med 1993; 328: 511-513. Preston FE, Jarvis LM, Markis M, et al. Heterogeneity of hepatitis C virus genotypes in haemophilia: relationship with chronic liver disease. Blood 1995; 85: 1259-1262. Farci P, Alter HJ, Govindarajan S, et al. Lack of protective immunity against reinfection with hepatitis C virus. Science 1992; 258: 135-140. King P. Renal transplantation. N Engl J Med 1994; 331: 1719. FŽray C, Gigou M, Samuel D, et al. Direct evidence for a more pathogenic effect of HCV type II: the model of liver transplantation. J Hepatol 1993; 28 Suppl 1: 54. Shorrock C, Neuberger J. The changing face of liver transplantation. Gut 1993; 34: 295-298. Authors' details Faculty of Medicine and Health Sciences, The University of Newcastle, NSW. Ian H Kerridge, BMed(Hons), MPhil, Lecturer in Clinical Ethics, Health Law and Ethics Programme, and Haematology Registrar, John Hunter Hospital. John Hunter Hospital, Newcastle, NSW. Peter Saul, FANZCA, FFICANZCA, Intensive Care Specialist; Robert G Batey, MD, FRACP, Associate Professor and Director, Department of Gastroenterology. No reprints will be available. Correspondence: Dr I H Kerridge, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW 2305. - Register to be notified of new articles by email - - To top of article - ©MJA1996 < URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Ian H Kerridge · Peter Saul · Robert G Batey

Is a general practitioner legally bound to render assistance to a stranger? Paul Gerber The finding that a general practitioner has a duty to attend any person in a medical emergency, in the absence of any previous professional relationship, is brand new law MJA1996; 165: 159-161 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright 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 email - - ©MJA 1996 The case of Woods v. Lowns and Procopis (decision of the Court of Appeal of NSW, handed down 5 February 1996: unpublished to date) is likely to have wide implications for the future practice of medicine in Australia. The trial involved two main issues: (i) should judges decide cases of medical negligence by acting on unproven scientific evidence contrary to the weight of expert medical opinion; and (ii) is there a legal obligation upon a general practitioner to attend a person with whom he or she has no professional relationship? I have dealt in the Journal with the first aspect of the case, 1 involving Dr Procopis. I was highly critical of the trial judge's finding against this specialist, concluding that his Honour had misconceived his role, and predicting that the "Procopis" component of his judgment would be reversed on appeal. My analysis did not meet with universal approval. 2 My criticism of the judge's handling of the evidence against Dr Procopis proved justified -- the verdict against the specialist was set aside on appeal. A majority of the Court of Appeal of the Supreme Court of New South Wales held that, while it is for the courts to decide the content of the duty of care which a medical specialist owes to a patient, it does not follow that a judge "will simply or readily put aside the considered judgment and/or experience of those skilled in the field and their opinion of what the care of the patient warranted" ( Woods v. Lowns and Procopis on appeal ). This concession has come some way toward attenuating the more extreme view generally ascribed to the decision in Rogers v. Whitaker 3 (i.e., that, generally speaking, the answer to the question whether the patient has been given all the relevant information to choose between undergoing and not undergoing the proposed treatment does not depend on medical standards or practice). Here I deal with the case against Dr Lowns, the general practitioner, who, at first instance, was held liable in negligence for failing to attend the plaintiff when allegedly requested to do so. The finding against him was upheld by majority of the Court of Appeal of the Supreme Court of New South Wales (Kirby P and Coles JA), who concluded that Dr Lowns, albeit a stranger to the plaintiff, was nevertheless liable for the unfortunate medical misadventure which resulted in the case, all said to be attributable to Dr Lowns' failure to attend the plaintiff at his home when requested to do so. The plaintiff, a boy aged ten years at the time, had a history of epilepsy and suffered an attack of status epilepticus in 1987 while on vacation with his family. Briefly, the relevant facts, taken from the trial judge's findings, were these: when the boy's mother -- after some considerable delay -- discovered that her son was fitting, she directed her older son "to go for an ambulance", and told her daughter (then nearly 15 years of age) "to go and get a doctor". The girl insisted that she went to Dr Lowns' surgery and spoke "to a man who answered the door". She claimed that she told that man that her mother had sent her because her brother was having a bad fit, that they had called for an ambulance, and "that we needed a doctor and could he come up?". The girl identified this man in Court as Dr Lowns, and claimed that he had refused to come, telling her instead to bring her brother to the surgery. By the time the ambulance arrived and took the boy to another medical practice (where he was injected with diazepam) and then to hospital (still fitting), he had suffered severe brain damage. The boy sued both Dr Procopis and Dr Lowns (as well as the two doctors who injected him with diazepam, a claim later withdrawn). At first instance, both Dr Procopis and Dr Lowns were found to have been negligent: Dr Procopis for having failed to instruct the parents in the use of rectal diazepam, and Dr Lowns for failing to attend the plaintiff at his home. At the trial, Dr Lowns denied that the girl had ever been to his surgery. His case was that the alleged conversation had never occurred. However, he made a number of fatal concessions: (i) that if he had been requested to attend the boy, he would -- and should -- have gone, (ii) that if he had attended the boy, he would have injected him with diazepam, and (iii) that if the boy had been treated at that point in time, it is probable that the tragic consequences would have been avoided. The identification of Dr Lowns by the boy's sister must be treated with considerable scepticism: she alleged that Dr Lowns was smoking a pipe (he does not), and there is little doubt that the doctor is not easily recognisable from her initial description of him. For good measure, the girl's ex- planations of these discrepancies lack conviction. This notwithstanding, the judge chose to believe her and rejected Dr Lowns' denial. (This finding was not challenged on appeal.) In the result, the judge entered a verdict in favour of the plaintiff in excess of $3 million. The finding that a general practitioner has a duty to attend any person in a medical emergency, in the absence of any previous professional relationship, is brand new law. With a stroke of a pen, the Court "discovered" a duty which did not previously exist. The origin of this so-called duty is found in the seminal speeches in Donoghue v. Stevenson, 4 where a majority of the House of Lords held, some 60 years ago, that a soft-drink manufacturer was liable in negligence to a plaintiff who claimed to have suffered an attack of gastroenteritis as a result of drinking the defendant's ginger beer (alleged to have contained the decomposed remnants of a snail). This case discovered the "neighbour" principle, "based upon a general public sentiment of moral wrongdoing for which the offender must pay" (per Lord Atkin, at p 580). 4 This "general public sentiment", excavated from the Old Testament, commanding that you are to love your neighbour, has mutated into law that you must not "injure" your neighbour. The legal question "who is my neighbour?" receives the restricted reply "persons so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts and omissions which are called in question" (per Lord Atkin, at p 580). 4 This "neighbour" principle had never previously been applied to doctor and stranger. Indeed, the trial judge himself (in Woods v. Lowns and Procopis ) noted: Something other than the foreseeability of harm is required before the law imposes a duty to intervene. It has been held in other common law jurisdictions that a doctor is under no duty to attend upon a person who is sick, even in an emergency, if that person is one to whom the doctor has not and never has been in a professional relationship of doctor and patient: see Jones, Medical Negligence , Sweet and Maxwell 1991 at p 24, par 2.21; Kennedy & Grubb, Medical Law , Butterworths (2nd ed) 1994 at p 79. His Honour cited a number of United States decisions, all of which held, firstly, that there can be no liability to attend to members of the public and, secondly, that there can be no negligence unless and until the relationship of doctor and patient has been established. How, then, did the majority impose this hitherto unknown legal obligation? The answer is that their Honours confused a moral duty with a legal one. The Medical Practitioners Act 1938 (NSW) s 27 (1) (now re-enacted in s 37 of the Medical Practice Act 1992 [NSW]) does state that "professional misconduct" in a registered medical practitioner is, inter alia: (h) refusing or failing, without reasonable cause, to attend, within a reasonable time after being requested to do so, on a person for the purpose of rendering professional services in the capacity of a registered medical practitioner in any case where the practitioner has reasonable cause to believe that the person is in need of urgent attention by a registered medical practitioner. However, while the legislation describes the contents of professional misconduct which will attract professional sanction, there is nothing in the Act which imposes a statutory obligation to attend a stranger, and it would be quite wrong to elevate "professional misconduct" to a breach of statutory duty, thus giving rise to an independent cause of action. It follows that those who maintain that the decision in Woods v. Lowns and Procopis is relevant only to medical practitioners in New South Wales are on shaky ground. I believe that, on appeal, only the dissenting judge (Mahoney AJ) correctly summarised the position when he stated: "We are concerned with whether the moral obligation to which (as I assume) the doctor was subject should be a legal obligation" ( Woods v. Lowns and Procopis, at p 13). His Honour noted that: Counsel have not been able to find any case in support of the present existence of such an obligation. Nor has any member of the Court. No case has been put to the contrary. I am conscious of the fiction that what the law creates has always been the law. But the implications of this case are great. . . . In this, as in other areas of law, the Court now faces squarely the nature of its decision: it prefers reality to fiction. Therefore, it is not inappropriate that I describe what the Court is here asked to do is imposing a legal obligation which presently does not exist ( Woods v. Lowns and Procopis, at p 15). I suggest that both the trial judge (Badgery-Parker J) and the majority of the Court of Appeal of the Supreme Court of NSW have not only "discovered" a relationship of proximity between doctor and stranger hitherto unknown to the law, but that they were wrong to hold that a doctor is under a legal duty to attend a person with whom he or she has had no previous professional relationship, a duty said to be based on the "proximity" or "neighbour" test, so that the only remaining question was whether the damage in suit was reasonably foreseeable if a doctor, otherwise in a position to do so, refused to render medical assistance. I submit that this is not only bad law; it is a blatant usurpation by the Court of what is solely the function of Parliament. If the Legislature wants to impose such a duty, so be it. It is not the business of judges to do so. While this is not the place to examine the history and development of the law of negligence, it is with no disrespect to the majority of the Court of Appeal to say that in the case Woods v. Lowns and Procopis Homer nodded,* and that the majority's reasoning was simplistic. It has long been held that the tort of negligence does not include -- save in a special relationship -- an obligation of rescue. The claim against Dr Lowns was argued in negligence and only in negligence; no breach of any other civil obligation was, or could have been, demonstrated. The answer to the plaintiff's claim must surely be that the tort of negligence does not extend to a failure by a doctor to attend a stranger. If there is such a duty, it must be sought elsewhere and, in this area, none of the cases to date have ever suggested that a person having goods or skill must provide them for the benefit of another. In this case, the majority sought to make a great deal of Dr Lowns' concession that, had he been requested to do so, he would and should have attended the plaintiff. The doctor went further, admitting in cross-examination that he could well foresee harm to a fitting child if he did not attend immediately and administer treatment. But that concession could not amount to an admission that he was under a legal obligation to attend the plaintiff, as the majority appear to have thought. After Dr Lowns indicated that he would seek special leave to appeal the decision to the High Court of Australia, the parties settled their claim. The medical profession is thus deprived of obtaining a more definitive pronouncement on a controversial decision in which, in my opinion, the majority of the New South Wales Court of Appeal came to a wrong conclusion, "bending" the law to reach a socially compelling result. References Gerber P. Has informed consent become a legal nightmare? Med J Aust 1995; 163: 262-264. Bates PW. Social and legal changes in medical malpractice litigation. Med J Aust 1995; 163: 264-268. Rogers v. Whitaker (1992) 175 CLR 479. Donoghue v. Stevenson [1932] AC 562 . Author's details 6 Devaney Lane, Corinda, QLD 4075. Paul Gerber, LLB, DJur, Adjunct Professor of Law, University of New South Wales. < URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Paul Gerber

The Professional Indemnity Review: what did it accomplish? Charlotta Blomberg In a previous article,* Richard Tjiong criticised the Professional Indemnity Review's specific recommendations for reform of professional indemnity insurance. But the Review covered many other issues, particularly to do with identifying, evaluating and reducing adverse outcomes of medical procedures. Charlotta Blomberg highlights some of the key findings (and failings) of the Review's Final Report. MJA 1996; 164: 502 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/>". Introduction - New research into health outcomes - Preventing adverse outcomes - Litigation crisis? - Compensation schemes - Drawing together medicine and law - In conclusion ... - References - Authors' details - - ©MJA1997 Introduction The Review of Professional Indemnity Arrangements for Health Care Professionals (chaired by Fiona Tito) was established against a background of increasing litigation, or fear of litigation, among health care professionals (see Box). Its purpose was to report to the then Minister for Health, Housing and Community Services on: the arrangements for patients injured through health care negligence or misadventure; the means of funding these arrangements; any problems with these arrangements; and proposed solutions and recommendations on the feasibility, appropriateness and estimated costs and benefits of these proposals.11 The last duty remains largely unfulfilled in the Final Report. Despite 168 detailed recommendations for changes of varying degrees, there is little discussion of feasibility, appropriateness or, more importantly, estimated costs and benefits. New research into health outcomes The Review embarked upon a 41/2-year investigation of the health care system and produced 19 publications (listed in Appendix C of the Report) in addition to the Final Report. The Review looked at the incidence and nature of health care injuries, compensation and structured settlements for personal injuries, facilities for the disabled, professional indemnity arrangements, "defensive" medicine and informed consent, birthing issues and information guidelines for patients and providers. At the start of the Review there was no information on the nature and extent of adverse outcomes, no readily available information on the number and types of health-related compensation claims and little publicly available information on the business operations of the medical defence organisations. The Report argues that lack of information on the issues under review required several individual studies to obtain the information required for decision making. Therefore, a major part of the Review was information gathering. It commissioned the Quality in Australian Health Care Study, which investigated the nature and extent of injuries suffered by patients in Australian hospitals. The preliminary results of this study were released in June 1995 and provoked considerable media attention. After peer review, the results were recently published in the MJA.12 With this study and others, the Review produced the first detailed analysis of the system of compensation for personal injury resulting from health care in Australia. The Final Report attempts to tie this considerable research work together with far-reaching recommendations which, if implemented in full, would radically alter the delivery and funding of health care in Australia. Preventing adverse outcomes The Quality in Australian Health Care Study defined an adverse event as "an unintended injury to a patient which resulted in a temporary or permanent disability, prolonged length of stay or death, and which was caused by health care management not by the patient's underlying disease".11 Under this broad definition the study found that hospital-based care produced over 400 000 adverse outcomes, with an estimated 230 000 of these being preventable. As a result, a considerable part of the Final Report concentrates on proposals aimed at preventing adverse outcomes. The solutions proposed involve the development of clinical practice guidelines based on evidence gained through the Cochrane Collaboration (which focuses on evidence derived from randomised controlled trials, conducted around the world and collectively analysed at the Cochrane Centre, Oxford University, UK). Medical services will be assessed on their efficacy and cost effectiveness. The Review recommends review of current services under the Medicare Benefits Schedule to establish their efficaciousness and cost-effectiveness. Commonwealth funding for those that fail these tests should cease (see Report recommendations 16, 19, 23, 28, 29 and 33).11 The emphasis on the development of clinical practice guidelines appears to stem from one of the findings of the Quality in Australian Health Care Study that system errors account for 16% of all adverse outcomes, with 53% of these due to the absence of or failure to use a policy, protocol or plan.12 However, the Study also concluded that "half of all AEs [adverse events] are deemed to have low or no preventability" and that this should be remembered "to avoid an inappropriate presumption of culpability when things go wrong".12 The Review does not address the difficulties associated with implementing a guidelines-based system of health care. The cost or cost-effectiveness of implementing these recommendations is not discussed, and no mention is made of what is involved (such as time and resources) in evidence-based reviews. There appears to be an underlying assumption that, if evidence-based guidelines are developed and followed, adverse outcomes will, in the main, be prevented. This "cookbook" approach to medicine has been criticised elsewhere.13 Without further debate of the issues, the Final Report fails to convince that strict adherence to evidence-based practice guidelines will achieve perfect outcomes. Litigation crisis? In the Final Report, the issues of professional indemnity, negligence actions and adverse outcomes were described as surrounded by myths and assertions supported by little hard data. Much of the information relating to the "litigation crisis" was anecdotal: "evidence for a so-called claims crisis is scant", said the Report, concluding that a crisis mentality has been fostered by some medical defence organisations to deflect attention from their own "irresponsible financial management".11 Although an increase in the rate of incident reporting was noted, the Final Report held that this did not appear to be reflected in an increase in claims filed in courts. It did acknowledge that there is often a considerable time lag between the reporting of an incident and the filing of a claim in court, which may imply recognition that the crisis may yet eventuate. The Review has rightly identified a lack of readily available information on common law negligence cases. A database of common law personal injury cases would be a valuable tool for monitoring the nature and frequency of legal claims, patterns of claims, the frequency of settlement and the amounts of awards and settlements. Such a project would require Commonwealth-State cooperation, as common law matters fall outside the Commonwealth's jurisdiction. The Report cites the register currently operating in South Australia and the National Practitioner Data Bank in the United States as models, but does not estimate the amount or nominate the source for funding of such a project. It does recommend that such a register would provide "a positive quality link between the tort system and the [practitioner] registration system" (Report, pages 154-155).11 This proposal must be studied further. It could mean registration would be subject to the frequency or value of claims incurred each year. It could mean a type of peer review that may establish that common law negligence is not to be equated with medical negligence. Unfortunately, the Report is not clear on what is meant. Compensation schemes In relation to compensation for those who have suffered personal injury as a result of health care, the Review recommended against the introduction of a "no-fault" scheme of compensation. Such a scheme would remove the need to prove negligence (fault) to receive compensation; proof of injury would suffice. It was rejected on grounds of inequity. The public interest is served by those who cause injury paying compensation. A no-fault scheme would mean that the full burden of assistance for injured persons would fall on the community as a whole through increased taxes and an overall reduction in resources available to those suffering injury as a result of health care.11 While recognising that there is inequity between the allocation of resources for those with compensable injuries and those with non-compensable injuries, the Report suggests that the overall public interest would be better served by the retention of the current system. The Review did investigate means of compensation other than the current lump sum awards. In many cases these, although seemingly generous, have proved to be inadequate when taken over the lifetime of a severely disabled person. Structured or serial payments in the place of lump-sum awards were offered as a solution. This is an alternative worthy of further consideration as it may provide security of assistance for those with severe permanent disabilities and solve the problem of awards being dissipated, eventually leaving the injured party relying on the public system. Drawing together medicine and law The Review has made useful recommendations in relation to the medicolegal system. Incorporating the study of legal issues into the training for health care professionals (Report recommendation 8), introducing a system of peer support for health professionals involved in negligence litigation (recommendation 89) and accrediting specialist health negligence lawyers (recommendation 94) are all worthy of further investigation. Greater positive and cooperative interaction between law and medicine is a desirable goal. Both professions would benefit from greater understanding and appreciation of each other's workings. Often people injured during medical procedures say that their main reason for pursuing legal actions is to find out what went wrong.14 This suggests that many potential actions may be prevented through appropriate advice at an early stage. A key factor in this process is access to expert opinions. The Review recommends a college-based system of encouraging high quality health professionals to provide expert opinions in medicolegal cases (Report recommendation 98). This type of system, along with appropriate legal training for medical experts, has been under review by the Australian Medical Association since last year. The existence of a pool of peer-recognised medicolegal experts available to give advice to plaintiffs, defendants and even the court itself may well have a positive effect on reducing litigation and delays inherent in the current system. Judges are keenly aware of the delays and costs attaching to civil actions and actively consider means to speed up their progress. The public interest is not served by lengthy delays and costly litigation. In conclusion . . . it's inconclusive The Final Report of the Review has not lived up to its high expectations. It has identified and investigated issues and proposed recommendations which raise more questions than they answer. There is little real assessment of the financial effect of the recommendations or the impact on current medical practice. The focus is on providing information for more effective decision-making. The legacy of the Review will be even more extensive consultations and reviews to develop practical solutions to the problems it has identified. References Tjiong R. The American litigation crisis is already here. Australian Medicine, 5 June 1995: 4. Bailie RS, Douglas RM. The future role and operation of Australian general practice survey results. Canberra: National Centre for Epidemiology and Population Health, 1995. Komesaroff PA, Keaney MA, Niselle P, Dunn IM. Is there a medical litigation crisis? MJA 1996; 164: 178-182. Keaney MA. Is litigation increasing? MJA 1996; 164: 178-179. Rogers v Whitaker (1992) 175 CLR 479. Lowns v Woods, by his next friend the Protective Commissioner & Ors Court of Appeal (NSW), unreported, 5 February 1996. O'Shea v Sullivan & Macquarie Pathology Services Pty Ltd (1994) Aust Tort Reports 81-273. Talbot & Anor v Lusby (1995) unreported, Supreme Court of Queensland, 14 July 1995. Litigation fears increase health bill. Australian Doctor, 1 September 1995: 48. Breen v Williams (1994) 35 NSWLR 522. Review of Professional Indemnity Arrangements for Health Care Professionals [Tito F, chairman]. Final Report. Compensation and professional indemnity in health care. Canberra: Commonwealth Department of Human Services and Health, 1995. Wilson RM, Runciman WB, Gibberd RW, et al. The Quality in Australian Health Care Study. MJA 1995; 163: 458-471. Arnold P. The Tito Report -- medical practice re-invented. Australian Medicine, 19 February 1996: 6. Vincent C, Young M, Phillips A, et al. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994; 343: 1609-1613.* See: Tjiong RTT. The Professional Indemnity Review. A lost opportunity for reform. MJA 1996; 164: 371-374. Authors' details Australian Medical Association, Canberra, ACT. Charlotta Blomberg, BA(Hons), LLB, Legal Advisor. Reprints: Ms Charlotta Blomberg, AMA, 42 Macquarie Street, Barton, ACT 2600. E-mail: cblombergATama.com.au ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Charlotta Blomberg