Ethics

Teacher-clinicians are not always adequate role models In 2000, the Australian Medical Council highlighted the place of clinical ethics in the education of medical students.1 A similar appreciation of its relevance has grown in the UK, North America and Europe.2-4 Recently, a working group of the Association of Teachers of Ethics and Law in Australian and New Zealand Medical Schools (ATEAM) produced a core curriculum for the subject5 that encompasses the knowledge, skills and attitudes required for students to appreciate the range and complexity of ethical issues permeating medicine and the moral principles required to deal with them. Who should teach ethics to medical students remains debatable, with some advocating a role for ethicists and others seeing the clinician as more appropriate. ATEAM argued that an optimal program embodies "multiple perspectives and multiple teachers".5 As the working group put it: "Teachers of ethics can play an important role in modeling the very nature of ethics: the teaching process should be perceived as being emotionally supportive and academically encouraging, should be tolerant of multiple perspectives, should be interdisciplinary and should actively involve clinicians as code-instructors and as role models for students. This also underscores the responsibility of teachers to develop as an ethical community and be alert to, and respond to, unethical behavior among themselves."5 Clinicians who are specifically recruited to teach clinical ethics are invariably selected on the basis of their sensitivity and commitment to the ethical dimension of the doctor–patient relationship; they are likely to serve as appropriate role models. Regrettably, during the course of their training, students may encounter other clinicians who lack sensitivity and manifest a disregard of ethical principles. In a survey of Canadian medical students, half reported pressure to act unethically and 60% had observed unethical conduct in a clinical teacher.6 Moreover, they had felt impotent in the face of these circumstances because of the teacher's intimidatory attitude. Having taught clinical ethics for almost three decades and on three continents, I have compiled a body of evidence of clinicians demonstrating wholly undesirable qualities and behaviour to medical students. In the context of case-centred teaching programs in ethics, students are requested to observe ethical aspects of practice during their attachment to a medical or surgical unit and then select an experience which has provoked their curiosity, generated concern or affected them in some way. The narrative of this experience is shared with a group of fellow students, one of whom serves as a scribe. As a result of this process, I have files containing dozens of ethically challenging scenarios (Box 1). The student dilemmaA recurrent theme in these scenarios is the students' powerlessness either to challenge the clinician or to intervene on the patient's behalf: "How can I, when placed at the very bottom of the hierarchy, voice my disapproval?" . . . "How can I come to the aid of patients when I am not directly responsible for them and this could be construed as acting beyond my remit?" . . . "How can I inform the Dean given that my quandary may well be divulged to the clinician himself?" Although these sorts of questions have been posed many times, I have always found it difficult to provide a rational response. After all, any advice to take action could well place students in professional jeopardy.7 When asked what factors inhibit students from speaking out, fear heads the list. Teacher-clinicians exert a strong influence over the student's future. They may be examiners or a source of references. Another commonly cited factor is the dominance of a professional culture which makes it taboo to question the clinical or professional conduct of a senior colleague. Mention is often made of an ethos whereby doctors should protect one another, especially in the face of a censorious environment and a siege mentality regarding the legal profession. Students note that "whistle blowing" is frowned upon and that the discloser of "medical secrets" is often ostracised.8 Students may not always feel confident that their critical reaction to an unethical clinician is justified: "Perhaps I am not able to tease out all the aspects?" . . . "Surely consultants with much more clinical experience and knowledge than myself must know what they are doing." . . . "Perhaps it is the best way of dealing with the situation." Other factors are probably rationalisations to justify retreating from a potential confrontation. For instance, are students justified in levelling criticism when they themselves may act unethically in the future, whether deliberately or inadvertently? Leeway is also given to the common plight which doctors, especially junior staff, face — working under great pressure with limited resources. Is it not understandable that a doctor may sometimes, in a state of frustration or fatigue, fail to maintain optimal ethical standards? Finally, questioning a consultant's clinical decision is akin to a student asking a teacher to clarify an objective position, but raising questions about an ethical judgement may penetrate more deeply and imply an attack on the personal qualities of the clinician. In minor instances, issuing this challenge may not seem worth the offence it may cause. In extreme cases, where a student surmises that a teacher is habitually unethical by dint of inherent deficiencies, the corollary may follow that "Such doctors unfortunately do exist and we have no choice but to tolerate them". If a series of teachers fail as ethical role models, students may well become disillusioned with their chosen profession. Instead of having an eager, energetic approach to medical life, they may become cynical and embittered. If insufficient good role models are available, students may miss the opportunity, at a formative period in their development, to enhance their own ethical capabilities. Students are well placed as members of an observant, intelligent peer group to contribute to the promotion of ethical standards by raising issues with their teachers. By not speaking out, avoidable patient distress may persist. The distress may be amplified by a sense of disillusionment that the "next generation" of doctors merely imitates the undesirable behaviours of their seniors. Students' acquiescence could be seen to maintain the status quo. James Dwyer7 captures the essence of the problem: "... the failure to speak up in certain situations is a failure of learning and caring." Moreover, the risk prevails that moral sensibility becomes eroded. Suggestions for changeGiven the adverse repercussions of negative ethical role modelling, I have sought the views of student groups over recent years as to how they may act. What follows is the product of these discussions. The cardinal change required is to remove the taboo on students "speaking up". Dwyer7 encapsulates this appositely by calling on students to subscribe to the Socratic maxim primum non tacere ("first, do not be silent") to fulfil their responsibilities to patients, colleagues and the medical profession. Abolishing the taboo depends on a number of overlapping factors. Altering the nature of the teacher–student relationship is paramount. The traditional hierarchical character of not only that association but of all the tiers of medicine embodies so many limitations that it ought to be ditched at the earliest opportunity. A more equitable link, similar to a partnership, is bound to be much more rewarding to both parties by permitting everyone to learn from each other's perspective.9 Here, the teacher must obviously modify well-entrenched habits and come to regard students as creative and curious. The learning process can be so much richer when it encompasses this interactive quality. The host environment, whether it be a hospital, a clinic or general practice, is another crucial variable in enabling the student to raise ethical questions. An institution whose ethos encourages ethical enquiry and is open to the challenge of optimising clinical care will listen carefully to the student's voice. The student may contribute to this spirit of ethical openness in at least two ways. Firstly, questions about ethical aspects of a clinical situation should be raised respectfully, avoiding judgementalism or personal denigration. Secondly, students should take care to broach delicate matters, which may well involve patient care, in a suitable setting. Thus, if distressed by an encounter between doctor and patient, they should refrain from questioning the teacher until in the private surroundings of the tutorial room. In proposing these two requirements of students, we have depicted them as individual protagonists. They may hesitate to raise an issue lest they are "out on a limb", their views stemming from an idiosyncratic source. Students would therefore do well to ventilate their concerns to their fellows and then share the task of questioning the clinician. The advantage of fellowship can be reinforced by reference to a code of ethics. A draft code for medical students published in 2002 by the Australian Medical Students' Association is an exemplary document comprising eight principles (Box 2), each of which is elaborated upon and clarified in a series of annotations.10 In the event of an experience with a negative role model, students can readily compare what they have observed with corresponding principles in their code. This comparison can then embolden them to challenge the teacher. If students experience difficulty because the teacher resists their enquiry they may feel helpless. The third annotation of Principle 6 of the AMSA code anticipates this by stipulating that: "When medical students experience difficulty with staff, they should discuss this with their academic mentor or supervisor." This is sound advice, although the student may be reluctant to follow it lest he or she be labelled a "whistle blower". Again, the notion of "security in numbers" applies. Fellow students who share a concern would no doubt find it easier to raise this as part of a group with a clinical dean or clinical supervisor. ConclusionNo matter how comprehensive and systematic the teaching of medical ethics, the acquisition of relevant skills and the cultivation of desirable attitudes will take place mainly in the clinical arena and be influenced by doctors who model an appreciation of the myriad ethical questions that pervade medical practice. Role models of good ethical conduct will always loom large in guiding the student to acquire a sense of moral integrity.11 Clinician-teachers share a duty to do all they can to expedite the process. Negative modelling is a destructive force which has no place in the learning environment. We all have a responsibility to confront and eradicate it. 1: Examples of ethically challenging situations faced by medical students The jocular doctor: In an effort to introduce each patient in a clinic to the observing students, a consultant either joked about them or referred to an amusing quality in them. Although the content and tone were not malicious, the students wondered whether this did not undermine the principle of respecting the dignity of the person. The students were sensitised given their experience not long before of a pair of surgeons talking indelicately about an anaesthetised patient under their joint care. The slanging match: A group of students were unnerved when witnessing a feud between a consultant and a ward sister, conducted in the passage and well within earshot of the patients. The pair had virtually come to blows over the issue of truth-telling. The nursing staff were convinced that a patient with advanced cancer sought the truth about her prognosis, whereas the consultant was of the view that she would be emotionally harmed if given an explicit prognosis. The students felt immobilised in the face of the increasingly acrimonious exchange. The scolding doctor: During the course of a consultation, a patient complained of a burning sensation in her legs. The clinician briefly reassured her that this was of no consequence. The pain appeared to worsen, the patient becoming tearful and distressed. Expecting further reassurance by the doctor or cessation of the examination, the students were staggered to hear his litany of criticisms of the patient for her not exercising or eating adequately. Later in the staff office, the doctor complained further about the patient, seemingly insensitive to her suffering. "All must palpate": Having examined a patient with an abdominal mass who was obviously in severe pain, the doctor instructed all eight students in the tutorial group to palpate her abdomen after the ward round. Half the group felt so intimidated by the clinician's "overbearing personality" that they examined the patient despite her request for the process to cease. The others felt it disrespectful to impose on the patient, but then had to lie to the teacher that they had "felt the mass". The "difficult" patient: The patient screamed out in pain when the doctor examined her pelvis. The observing student was startled to hear the doctor then reprimand the patient for acting "hysterically" and losing control. Later, but still at the bedside, he explained to the student that she was a "difficult personality" and had always responded in this "exaggerated" way. 2: Principles from the Australian Medical Students' Association Code of Ethics — preliminary draft Medical students should: respect the needs, values and culture of patients they encounter during their medical training; never exploit patients or their families; hold clinical information in confidence; obtain informed consent from patients before involving them in any aspect of training; appreciate the limits of their role in the clinical setting and in the community; respect the staff who teach and assist them in their clinical training; when involved in clinical research adhere to the ethical principles in the appropriate national and international guidelines; maintain their personal integrity and well being.

Sidney Bloch PhD, FRANZCP

Imprecise language and deliberate confusion of important ethical and legal concepts are clouding our understanding of controversial end-of-life issues. This could affect our decision about whether or not to legalise euthanasia. In postmodern societies, the euthanasia and physician-assisted suicide debate is an important forum for the "death talk" through which we accommodate — with as much comfort as possible — the reality of death into the living of our lives.1 Recently, I debated Dr Philip Nitschke, at the Australian Medical Association's Annual General Meeting in Canberra, 24–26 May 2002, on whether euthanasia and physician-assisted suicide should be legalised. Dr Nitschke advocates such legalisation; I oppose it. In this article, I discuss my impressions of the discussion of euthanasia that took place at that AMA meeting and respond to it. Euthanasia is "a deliberate act that causes death undertaken by one person with the primary intention of ending the life of another person, in order to relieve that person's suffering."1 Throughout, I use the word "euthanasia" to include also physician-assisted suicide (although I recognise that in some situations, not discussed here, they must be differentiated). Language mattersLanguage is not neutral, especially in the euthanasia debate. We must choose and use our words carefully and precisely if we are to avoid inadvertently opening the way for the legalisation of euthanasia. For instance, saying that patients must be offered all treatment necessary to relieve their pain, even if that treatment could or would shorten life, or they must be offered all treatment necessary to relieve their suffering, may seem the same. But, properly interpreted, the former statement does not open up the possibility of legitimating euthanasia; the latter could do so and could affect the law accordingly. The language used in some of the resolutions passed by AMA delegates at the meeting can be interpreted several ways, thus creating confusion as to whether delegates had moved from opposing euthanasia absolutely towards approving it. Consequently, the media produced front-page headlines stating that the AMA had switched its policy on euthanasia and had "cleared [doctors] to 'hasten death'."2 Resolution 3Take, for instance, Resolution 3, which stated: National Conference recommends . . . that AMA policy be amended to read "that the AMA support doctors whose primary intent is to relieve the suffering and distress of terminally ill patients in accordance with patients' wishes and interests, even though a foreseen secondary consequence is the hastening of death." Most doctors to whom I spoke at the meeting said they saw this resolution as nothing more than a reaffirmation of the AMA's current position, which, consistent with current ethics and law, rejects euthanasia and supports offering patients all necessary pain-relief treatment, even if it could or would shorten life. However, this resolution might inadvertently go well beyond that. First, the resolution is not limited to pain relief: it refers to relief of "the suffering and distress of terminally ill patients" — a much broader category of symptoms and situations than just pain. Language to better reflect the present AMA position would be "the relief of pain and other symptoms of serious physical distress of terminally ill patients." Secondly, Resolution 3 implies that "the patient's wishes and interests" justify the life-shortening treatment — a key argument of the pro-euthanasia lobby. They argue that competent individuals' informed consent to euthanasia justifies giving them lethal injections. Opponents of euthanasia believe that a person's consent to having death inflicted does not justify another person inflicting death. This latter belief is enshrined in contemporary criminal law, except in countries such as the Netherlands and Belgium, which allow an exception for euthanasia. Further, Resolution 3 could be taken as legitimating the pursuit of death as a secondary consequence, not simply tolerating it as an unavoidable, unwanted consequence. In ethics and law, the difference between these two situations is reflected in the very significant distinction drawn between justifying an unwanted consequence (here, death) and excusing it. "Double-effect" doctrineThe legal doctrine of "double effect" justifies giving pain-relief treatment, provided it is given with the primary intention to relieve pain, and excuses any unavoidable, but unwanted, life-shortening effect of doing so. In short, the act of pain relief is justified — it is a right act; its unwanted consequence of shortening life is excused (ie, tolerated) in the circumstances. Let me explain why the distinction between a justification and an excuse is important in this context: an excuse carries the message that shortening life is wrong, but the person who does so will not be prosecuted (ie, he or she will have legal immunity). The message of a justification — as implied by the wording used in Resolution 3 — is that the conduct of shortening life is right. When considered as a justification, Resolution 3 can also support another pro-euthanasia line of argument: given that doctors have now accepted that hastening death is acceptable and justifiable as a secondary effect, it should not be unacceptable and unjustifiable as a primary intention. In contrast, interpreting the doctrine of "double effect", as suggested above, would not be open to such reasoning. It says that the secondary effect of hastening the death of the patient in providing necessary pain-relief treatment is unwanted and must never be a desired consequence, but, to the strict extent necessary to relieve pain, it is excused in law. That approach also reflects many people's moral intuitions that we must relieve pain, but it is wrong to kill. The doctrine of "double effect" requires, first, that the act resulting in a bad consequence (such as the shortening of life) is morally neutral. Providing pain-relief treatment would qualify as at least a morally neutral act. Second, the pain relief must not be achieved by shortening life (ie, through a bad consequence). Third, the bad consequence, the shortening of life, must not be primarily intended as either an end or a means; rather, the primary intent must be the legitimate aim of relieving pain. Fourth, there must be no other reasonable way of achieving the pain relief without involving the undesired effect of shortening life. Lastly, the proportionality of good and bad consequences required to justify the bad ones must be present. Providing necessary pain relief, even if it shortens life, fulfils all of these conditions; euthanasia fulfils none of them. ConfusionThat the delegates might themselves have been confused about the possible meaning of Resolution 3, which they passed (65 to 48 votes), could be indicated by their rejection (34 to 79 votes) of Resolution 4. That resolution proposed . . . that the AMA "work towards . . . adopt[ing] a neutral position on the issue of voluntary euthanasia." The 31 doctors who voted for Resolution 3, but against Resolution 4 (assuming the same 113 doctors voted in each case), obviously had no idea that Resolution 3 could be interpreted as moving towards acceptance of euthanasia, because they opposed even a neutral stance on it. A neutral stance would be, in fact, not only a move away from opposing euthanasia, but a move towards euthanasia. Its message is that, in principle, there are no moral, ethical or legal reasons to oppose euthanasia; rather, its acceptability is a matter of personal conscience and whether any associated potential abuse can be prevented. Yet another indication that the doctors might not have understood the ambiguity of the language of Resolution 3 and the inconsistency between voting for it and against Resolution 4 is that Resolution 1 was passed with only four against votes. It expressly rejects euthanasia: "[T]he AMA . . . absolutely reject[s] any intervention whose primary intent is to bring about the death of a patient . . ." This resolution distinguishes acting with such an intent — euthanasia — from the justified withdrawal of life-support treatment that results in death, and advocates educating the community about palliative care and ensuring that its provision is given high priority. In short, the resolution outlines a comprehensive anti-euthanasia approach to caring for terminally ill people. Confusion compoundedAfter the AMA conference, a well-known euthanasia advocate posted an email on the Deliverance (Voluntary Euthanasia Australia) chat line commenting on its outcome (List Member, Friday, June 21, 2002). The email stated that one of the participants at the meeting: ". . . got it absolutely right when he said that the principle of double effect allows doctors and others to hide behind it [to carry out euthanasia]. In light of the AMA's plan to (re-)educate doctors on the difference between "ethical care" and "euthanasia" this has particular significance : what the AMA "education" campaign is likely to amount to is to tell doctors to keep their minds off the foreseen consequences of what they do — to aim at pain-relief, not death." This email reflects an important modus operandi of euthanasia advocates — to work for the acceptance and legalisation of euthanasia by intentionally creating multiple confusions between it and other conduct that is ethically and legally acceptable in treating terminally ill patients. I call it "euthanasia by confusion".1 Disputed distinctionsPain-relief treatment versus euthanasiaA key target in creating this confusion is the doctrine of "double effect". It is attacked through allegations that the doctor's goal — his or her intent — and the cause of the patient's death — the causation — are the same in giving pain-relief treatment that could shorten life and in euthanasia. In other words, euthanasia advocates claim that the doctrine of "double effect" is just legal sophistry and that pain-relief treatment that could shorten life is really euthanasia. Those who oppose euthanasia argue that provision of pain-relief treatment is different in kind, not just degree, from euthanasia, because the intent is different. Necessary pain-relief treatment, even that which could shorten life, does not involve a primary intention to kill the patient; euthanasia does. Profound ethical and legal differences hinge on whether such an intent is present. As the Deliverance email demonstrates, euthanasia advocates also claim that doctors are hypocritically hiding behind the permissibility of giving pain relief under the doctrine of "double effect" — in fact, to carry out euthanasia. That is, they claim that, in practice, in giving pain-relief treatment, many doctors are acting with a primary intention of killing patients, not of relieving their pain. Often these claims are made on the basis of the large amount of pain-relief treatment given. But provided the dose (even if it is very large) is necessary to relieve the patient's pain and given with the primary intention of doing so, that is not euthanasia. Where it is clear that these conditions are not fulfilled, it would be euthanasia. There are serious harms in arguing that giving necessary pain relief is euthanasia: it could make doctors frightened to provide it. They must be reassured that they will not be legally liable; indeed, as the law is now developing, they are more likely to be liable for not doing so. Withdrawal of life support versus euthanasiaEuthanasia advocates also deliberately confuse withdrawal of life-support treatment with euthanasia. They argue there is no difference in either intention or causation between withdrawing life-support treatment when it results in the person's death and giving that person a lethal injection. They say that in both cases the doctor kills the patient (ie, causes the patient's death). This commonality of causation means they argue that, if we agree to respect refusals of life-support treatment, we must also agree with euthanasia. Moreover, they claim that, if there is no moral or ethical difference between refusals of treatment that result in death and euthanasia, there ought to be no legal difference. Those who oppose euthanasia disagree. They argue that refusals of treatment are morally and ethically different from euthanasia and ought to remain legally different. There are long-established, well understood, profound and important differences between allowing people to die, when it is ethically and legally justified, and making them die (ie, putting them to death). Respecting people's refusals of life-saving treatment belongs in the former category, euthanasia in the latter. The right to refuse treatment flows from a right to inviolability — a right not to be touched, including by continuing treatment, without one's consent — not from a right to die. There is therefore a right to have treatment withdrawn, which means that death will result from (ie, be caused by) the patient's underlying illness, but there is no right to be killed. Causing a patient's death through administering a lethal injection is different in kind from death resulting from refusal of treatment. The same line of pro-euthanasia argument is also constructed through a confusion of means and ends. This argument is that when death is the inevitable outcome, the means used to achieve that — whether withdrawing life support or a lethal injection — are morally irrelevant and ought to be legally irrelevant. But the means through which we die matter morally and should continue to matter legally. The issue is not if we die — we all die; it is how we die. Deep moral intuitions have long informed us that there are important distinctions between "letting nature take its course", including by refusal of life-support treatment, and killing a dying person. Death: purely private or societal impact?Advocates of euthanasia also argue that that how we die is just a private matter. Opponents of legalising euthanasia reject that argument. They believe each person's death necessarily involves others, including healthcare professionals, and societal values and symbols. Moreover, if euthanasia is involved, how we die cannot be just a private matter of self-determination and personal beliefs, because euthanasia "is an act that requires two people to make it possible and a complicit society to make it acceptable."3 Impact of legalising euthanasiaChanging the norm that we must not kill each other would cause profound damage to society. There would also be serious damage to institutions — in particular, medicine and the law — that maintain respect for human life, especially in a secular, pluralistic society that no longer has a shared religion to carry such values. Fundamental valuesAmong the fundamental elements of the case against euthanasia is its contravention of the principle that to act with a primary intention of killing another person is inherently wrong (except in justified self-defence or defence of others). To legalise euthanasia would damage important, foundational societal values and symbols that uphold respect for human life. In fact, the prohibition on intentionally killing is the cornerstone of law and human relationships, emphasising our basic equality.4 To legalise euthanasia would be to change the way we understand ourselves, human life and its meaning. And a more pragmatic, but nevertheless very important, objection is that abuse of legalised euthanasia cannot be prevented, as recent reports on euthanasia in the Netherlands have documented.5,6 In response, euthanasia advocates argue, in support of legalising it, that doctors are secretly carrying it out anyway. They claim to have found a high incidence of secret euthanasia by healthcare professionals, for example in Australia.7 However, that study has recently been severely criticised on the grounds that the respondents replied to questions that did not distinguish between actions intended to shorten life — euthanasia — and other acts or omissions in which no such intention was present — pain-relief treatment or refusals of treatment — that are not euthanasia. Consequently, the researchers' estimates of the number of cases of hidden euthanasia may be grossly exaggerated.8 But, even if accurate, the fact that doctors are secretly carrying out euthanasia does not mean that it is right. (Further, if doctors were presently ignoring the law against murder, why would they obey guidelines for voluntary euthanasia?) Lethal impactWhat impact might legalising euthanasia have on society? In answering questions of impact we must not look at euthanasia just in relation to individuals or in isolation from the context in which it would operate: at a societal level, the combination of an ageing population, scarce healthcare resources and euthanasia would be a lethal one. And what impact might the consequent message — that suicide is an appropriate response to suffering — have on people who are suicidal? What impact would legalising euthanasia have on the profession of medicine? Euthanasia "places the very soul of medicine on trial".9 Doctors' absolute repugnance to killing people is necessary to maintaining people's and society's trust in them. This is true, in part, because doctors have opportunities to kill not open to other people, as the horrific story of Dr Harold Shipman, the UK physician-serial killer, shows. It would be very difficult to communicate to doctors a repugnance to killing in a context of legalised euthanasia. Harm to medicine also harms society. We need to protect the institution of medicine not just for its own sake, but also because it is a very important value-creating, value-carrying and values-consensus-forming institution, especially in a secular society. How would legalising euthanasia affect medical education? What impact would physician role models carrying out euthanasia have on medical students and young physicians? Would we devote time to teaching students how to administer death through lethal injection? Would they be brutalised or ethically desensitised? (Do we adequately teach pain-relief treatment at present?) Last wordsPhysician-assisted suicide and euthanasia are simplistic, wrong and dangerous responses to the complex reality of human death. For physicians to give lethal injections to their patients or to assist them to commit suicide is inherently wrong from the perspective of principle-based or deontological ethics. But even on a utilitarian or situational ethics analysis, it is ethically wrong — the risks and harms outweigh the benefits. Physician-assisted suicide and euthanasia involves taking people who are at their weakest and most vulnerable, who fear loss of control or isolation and abandonment — in a state of intense "pre-mortem loneliness"10 — and placing them in a situation where they believe their only alternative is to kill themselves. Nancy Crick, a 69-year-old Australian grandmother, was Dr Nitschke's patient. Mrs Crick committed suicide in the presence of over 20 people, eight of whom were members of the Australian Voluntary Euthanasia Society. She explained: "I don't want to die alone." Another option for Mrs Crick should have been to die naturally with people who cared for her present. Was she offered that option? Of people who requested assisted suicide under Oregon's Death with Dignity Act, which allows physicians to prescribe lethal medication, 46% changed their minds after significant palliative-care interventions (relief of pain and other symptoms), but only 15% of those who did not receive such interventions did so.11 How a society treats its weakest, most in need, most vulnerable members best tests its moral and ethical tone. Thus, what doctors decide about euthanasia will play a very large part in determining Australia's moral and ethical tone — far into the future.

Margaret A Somerville AM, FRSC, LLB, LLD (Hon)

Refusal of a parent to have a child vaccinated against tetanus raised ethical issues for the treating clinicians. The clinicians felt their duty to the child was compromised, but recognised that our society leaves the authority for such decisions with the parents. As there was no reason, other than different beliefs about vaccination, to doubt the parent's care for the child, the clinicians limited their response to providing strong recommendations in favour of vaccination. Other issues raised by this case include community protection, and the costs to the community of treating a vaccine-preventable disease.

Paul N Goldwater FRACP, FRCPA · Richard G Power FRACP, MRCP(UK) · Paul H Henning FRACP · Terence G Donald FRACP · Jon N Jureidini PhD, FRANZCP · Christine F Finlay RN, RM · Annette J Braunack-Mayer BMedSci(Hons), PhD · Mike S Gold FRACP, MD

To the Editor: We are writing to add our wholehearted support to the plea made by Carapetis et al1 for a simplified ethical approval process for multicentre studies. We are conducting two national case-controlled studies of cancer in Australia, funded by grants from the National Institutes of Health and the Department of Defense in the United States, as well as the National Health and Medical Research Council (NHMRC). Our ability to achieve full population coverage was a major competitive advantage in terms of securing international funding. However, to realise this objective, we have spent more than a year obtaining ethics approval from the myriad institutions controlling access to patients and the public. We have been required to make more than 60 separate ethics applications, lodging about 550 copies of the proposal (a total of 40 000 sheets) at a cost of more than $7000 for paper and printing alone. When labour is included the cost of the initial submissions escalates to $16 000 (excluding substantial investigator time). Other costs include the extraordinary requirement of one ethics committee in Victoria that an investigator from Queensland personally attend a 10-minute interview at which no substantive issues were raised. The ethical benefit of this investment must be questioned when the majority of changes required by committees have dealt with minor issues such as grammatical style that have little to do with patient protection. Inevitably, such directives are inconsistent across institutions. It is thus impossible to comply with all requests while maintaining a standard set of study documents. These problems are accentuated for the increasing number of Australian researchers relying on overseas funding. For example, regulatory authorities in the United States insist that all ethics committees reviewing US-funded projects involving humans must have US federal approval to do so. In our experience, few Australian hospital ethics committees have this approval. Therefore, in addition to fulfilling standard institutional ethics requirements, we have also had to help several committees go through the lengthy process of securing US accreditation simply to approve our study! For all the above reasons, we strongly believe that Australian researchers and patients would be best served by a single national ethics committee for large multicentre studies. This would also reduce the enormous burden currently placed on the individual committees. In the meantime, we thank Breen and Hacker2 for their reminder to institutional ethics committees that the NHMRC national statement "empowers ethics committees to minimise unnecessary duplication".

David C Whiteman · Penelope M Webb · David M Purdie · Adèle C Green

Self-experimentation in Australia is alive and well Many advances in modern medicine owe a great deal to human experimentation. Indeed, much of biomedical research is irrelevant to mainstream medicine unless its clinical utility is established through human experimentation, for, as observed by the English essayist Alexander Pope, "the proper study of mankind is man."1 Today the circumstances and conduct of human experimentation are painstakingly policed by ethics committees, but even such strict surveillance cannot guarantee safety: "because experiments with humans are voyages into the unknown, an element of risk is always involved; the potential for death, injury, or illness can be reduced, but it can not be eliminated."2 It is this very uncertainty that presents a dilemma for researchers. Sir George Pickering, past Regius Professor of Medicine at Oxford, delineated this quandary: "The experimenter has one golden rule to guide him . . . Is he prepared to submit himself to the procedure? If he is, and if the experiment is actually carried out on him, then it is probably justifiable. If he is not, then [it] should not be done."2 In short, the researcher should be the guinea pig. Risk-laden stories of researchers being guinea pigs abound in medicine's heritage. They include that of John Hunter, the 18th-century English anatomist and surgeon, who allegedly inoculated himself with venereal pus. The symptoms of gonorrhoea and primary syphilis were soon apparent and during the last 15 years of his life he was plagued by a legacy of angina pectoris presumably due to tertiary syphilis.2,3 Other celebrated accounts include that of Werner Forssmann, who, in the 1920s, catheterised his heart with ureteric tubes. This risk-laden technique lay fallow until the 1940s, when Cournand and Richards in the United States refined and employed it in ground-breaking work in cardiorespiratory physiology. In 1956, all three were awarded the Nobel Prize in Medicine or Physiology.2 In the 1950s the enthusiasm for self-experimentation within the Department of Internal Medicine at Washington University, St Louis, earned it the name the "Kamikaze School of Medicine".2 Bill Harrington, a young researcher, courted death from cerebral haemorrhage with profound thrombocytopenia after being infused with plasma from a patient with idiopathic thrombocytopenic purpura (ITP).2 A fellow researcher, Tom Brittingham III, repeatedly injected himself with leukaemic white cells in an attempt to produce white-cell antibodies. He almost killed himself when he had an anaphylactoid reaction accompanied by profound hypotension and severe pulmonary oedema after being infused with plasma from a patient with aplastic anaemia.2 Nonetheless, these unsettling self-experiments established the immune basis of ITP and white-cell-associated transfusion reactions. Harrington's work inspired Jan Dausset of Paris to pursue research into the immunology of ITP and white cells, which culminated in his being awarded the 1980 Nobel Prize for demonstrating human leukocyte antigen (HLA; the transplantation antigen) in white cells.2 Australian researchers have also succumbed to the human guinea pig syndrome. In 1951, as the first wave of myxomatosis raced along the Murray River, its arrival in Mildura coincided with an outbreak of Murray Valley encephalitis in the surrounding district. The public was gripped by fear that the myxoma virus was responsible for the outbreak of encephalitis. This fear reached such heights that the chairman of Mildura Base Hospital challenged R G Casey, the Minister responsible for the Commonwealth Scientific and Industrial Research Organisation (CSIRO), and Sir Frank Macfarlane Burnet, Director of the Walter and Eliza Hall Institute (WEHI), to test the harmlessness of the myxoma virus on themselves! Spurred on by intense media pressure, Macfarlane Burnet, Frank Fenner (Professor of Microbiology at the John Curtin School of Medicine, but working at WEHI) and Ian Clunies Ross (Director of the CSIRO) inoculated themselves with enough myxoma virus to kill 100–1000 rabbits. All three suffered no harm, and in true political style this fact was made public by Casey through an announcement in Federal Parliament.4 The culture of the Kamikaze School of Medicine was further manifest when Australian clinical researchers performed radiolabelled platelet studies on themselves,5 or underwent unpleasant bone marrow aspirations to procure marrow cells for drug studies.6,7 Finally, the experiments of Barry Marshall, who ingested Helicobacter pylori,8 are now legend in medicine. His self-experiments eventually turned prevailing concepts of peptic ulcer causation and treatment on their head. Now, in the new millennium, the report in this issue of the Journal by Landmann and Prociv attests that self-experimentation in Australia is alive and well. In a series of self-experiments these investigators have shown that dog hookworm (Ancylostoma caninum) infection causing symptomatic eosinophilic enteritis is more likely to enter the body orally than percutaneously.9 What drives researchers to be their own guinea pigs? Lawrence Altman, in his delightful book Who goes first? The story of self-experimentation in medicine, proposes a number of motivating factors.2 These include reliability (researchers being more likely to adhere compulsively to the research protocol), dependability (for observations and detecting problems with design), a spirit of adventure, first-hand experience, self-protection, convenience (avoiding the frustrations of recruiting and being involved in the nuances of informed consent) and experience (when the experiments involve risk, the experience of the researcher is important and many will risk exposing themselves rather than others). However, self-experiments are subject to criticism.2 Potential problems include loss of objectivity, cumulative exposure to risks and comorbidities in the self-researcher (including self-experimentation suicide), but particularly the inherent limitations of a research design focusing on a single subject.10 Despite all this, researchers who enlist as guinea pigs will continue to grace medical research. Modern research is increasingly complex, with sophisticated designs and statistics, bewildering technology and the added burden of the close monitoring of projects by ethics committees. This impersonal and mechanistic culture is far removed from the humanistic and romantic spirit of adventure embodied in altruistic self-experimentation. As long as human research is informed by the premise that "because we were venturing into the unknown . . . a man is entitled to risk his own life. He is not entitled to risk somebody else's",2 researchers as guinea pigs will always be with us.

Martin B Van Der Weyden MD, FRACP, FRCPA

To the Editor: Survey data are difficult to publish when response rates fall below 60%. Reminder letters are the most reliable method of improving response rates in postal surveys,1,2 and three to four reminders are needed to achieve the 60% benchmark. The additional benefit of sending five or more reminders appears negligible, suggesting that four is the optimum number to maximise response rates using this approach.1 Our recent experiences suggest that human research ethics committees (HRECs) are seeking to limit the number of reminder letters on the grounds that they could be construed as harassment of research subjects. We recently submitted applications to two HRECs, seeking permission to conduct a multicentre postal survey in our local area. One committee approved the use of a single reminder letter, while the second approved the use of two. We appealed both decisions, citing evidence from earlier studies.1,2 The first committee reversed its decision and subsequently approved use of three reminders; the second committee upheld its decision to allow only two reminders. Thus, our study was effectively restricted to two reminder letters. These experiences highlight two limitations of the ethics review process in Australia. First, the process is highly fragmented and lacks standardisation. HRECs exist as autonomous and independent entities, with varying interpretations of ethical practice. The decisions of one committee frequently undermine those of another. This is frustrating for researchers, who often have to seek permission from two or more committees during the course of a study. Second, the process confers higher status on the rights of study participants than on the methodological demands of science. Whenever there is any actual or perceived conflict between the two, HRECs consistently rule in favour of individual rights. Researchers are reluctant to challenge the decisions of their local committee, as there is no independent review process, and appeals are usually referred back to the original committee. The result is a directive and autocratic process which fails to consider the demands of scientifically valid research. Under current guidelines of the National Health and Medical Research Council, HRECs may endorse procedures that are potentially invasive or intrusive, provided certain conditions are met: the procedures are scientifically justified; there is no acceptable alternative; and reasonable steps are taken to protect individual rights. This certainly provides scope for sanctioning four reminder letters in postal surveys.

Stuart C Howell · Susan Quine · Nicholas J Talley

Comment: Howell and his coauthors invite human research ethics committees (HRECs) to standardise their judgements about key aspects of methods, such as response-aiding strategies.1 Their balanced and thoughtful analysis of their experience in securing approval from two HRECs for reminders to enhance response rates to a postal community survey adds to previous concerns about decision-making by HRECs in Australia.2,3 In an era of evidence-based healthcare, there are two main reasons to insist that HRECs only approve protocols for surveys that propose scientifically based procedures to increase response rates. First, applicants are applying empirical insights from previous research in their own practice. Hence, methods are evidence based. Second, applicants are doing their best to ensure the validity of their future data. As eloquently quantified elsewhere, surveys with low response rates are plagued by response bias.4 Indeed, it was recently asserted that, for mailed surveys, "you need an 80–85% response rate to make it epidemiologically significant".5 Fortunately, there is the most rigorous evidence (Level 1) for specific response-aiding strategies for surveys of medical practitioners in Australia.6 Howell and colleagues cite two recent studies of response-aiding strategies in lay surveys. Yet such compelling evidence appears to have been inadequate to secure identical responses from at least two HRECs. That both required Howell and colleagues to apply "homoeopathic" measures to their reminders (sending two rather than the proven four reminder letters) suggests that these HRECs may have been poorly apprised of the relevant scientific literature, unconvinced of its generalisability, or concerned about the acceptability of proposed procedures to research participants. As current National Health and Medical Research Council (NHMRC) guidelines provide a framework for approving research procedures that are "scientifically justified", it seems HRECs would benefit from regular and independent updates about key methodological advances, such as response-aiding strategies, their benefits, risks and harms. I am mindful that such methodological guidance must not add unnecessarily to the copious reading that is already typically demanded of members of HRECs. Perhaps the NHMRC Australian Health Ethics Committee could consider this issue in its next triennium, to commence 2003.

Jeanette E Ward

To the Editor: "Chop-chop" tobacco is illicit tobacco that has been grown and clandestinely distributed by farmers and wholesalers and sold on without government intervention or taxation. There is no quality control over this illicit substance, which may be adulterated or "bulked up". It is sold illegally "under the counter" by weight for rolled cigarettes by unscrupulous tobacconists and grocers. This type of tobacco, which has been roughly chopped up (hence "chop-chop"), is very cheap compared with legally produced manufactured cigarettes. The prevalence of the use of chop-chop in the smoking community is unknown. However, the Australian Taxation Office (ATO) has a keen interest in the distribution of this substance, and estimates that many millions of dollars are lost in revenue from the illegal sale of chop-chop. Arrests and fines initiated by the ATO have so far occurred primarily in Queensland and Victoria. Results of analysis of chop-chop vary from batch to batch, but samples have been shown to contain nicotine (Professor G Starmer, Department of Pharmacology, and Mr B Tattam, Mass Spectrometry Unit, Department of Pharmacy, University of Sydney, personal communication). It may also be fumigated with bleach and may be bulked up to add weight (M Rushton, ATO, personal communication). Although most people smoke it because it is cheap, many have misguided beliefs, for which there is no evidence, that it is "better" than other forms of tobacco. Results of a survey of 44 consecutive patients attending the Smokers' Clinics of the Central Sydney Area Health Service 43% currently using "chop-chop" 84% smoke it because it is cheaper 58% believe it is better for you 74% believe it has no additives 16% believe it has no nicotine 63% know it is not legal A retrospective survey was carried out to assess the prevalence of and attitudes towards illicit tobacco smoking among patients attending the Smokers' Clinics of the Central Sydney Area Health Service (approved by the CSAHS Ethics Committee, June 2002). Patients were routinely asked the type of tobacco they smoked and their beliefs regarding this type of tobacco. The results are shown in the Box. Many of the patients attending the Smokers' Clinics (dedicated exclusively to patients who smoke and have chronic obstructive pulmonary disease [COPD]) smoke this type of illegal tobacco. Several patients volunteered that smoking chop-chop precipitated an acute exacerbation of their COPD. Four patients have recently presented to a hospital emergency department for exacerbation of COPD after smoking chop-chop. Although smokers are loath to volunteer their use of this illegal tobacco, smokers and clinicians should be warned that smoking chop-chop does not constitute a positive health move, is not less harmful, and may be quite dangerous. Quitting smoking altogether is the best health move.

Renee Bittoun

Simple statements of risks and benefits may not reveal the complexity of human responses to research participation In this issue of the Journal, Scott and colleagues (page 507) report on a retrospective study of family members' experience of participation in a previous study following their child's diagnosis with Ewing's sarcoma.1 The research is important because it casts empirical light on an ethical issue often debated in human research ethics committee meetings: how does research affect those who participate in it? Ethics committees can be very cautious about granting approval for research into sensitive areas because of concern about the impact on research participants. People participate in research for many reasons. They may feel an obligation to their doctor, they may not think they have a choice in the matter, they may hope or believe they will benefit from the research, or they may just wish to help others.2-4 Regardless of the reasons research participants may have for participating, the National Health and Medical Research Council (NHMRC) guidelines5 make clear that the primary duty of members of ethics committees is to attend to the "dignity and wellbeing" of research participants. Ethics committees focus, above all, on the risk of harm or discomfort to participants and on the requirement that participants make a free and informed choice to participate in research. Committees need to bear in mind that In clinical research . . . the risks of participation must be balanced by the possibility of intended benefits to the participants. In other research involving humans . . . the absence of intended benefits to a participant should justly be balanced by the absence of all but minimal risk.2 However, the data from Scott et al suggest that balancing risks and benefits is not necessarily a straightforward matter. How research participants experience risks and benefits can be rather complex. First — at least for research into sensitive areas such as serious and life-threatening illness — participants may find it painful and distressing to recall past events or articulate complex emotions. However, doing so in a supportive environment may actually be beneficial. Scott et al indicate that the benefits gained by participants in their study came despite the pain of talking about distressing events. I would argue that the evidence in their article suggests that some benefits seemed to accrue to participants because they could talk about painful experiences. Ethics committees may be able to separate out the risks and benefits conceptually, but in people's experience of taking part in research, as in other areas of our lives, things are seldom so tidy. Furthermore, the qualitative data reported imply that an additional benefit to participants was the opportunity to learn more about Ewing's sarcoma. Research participants often ask questions — about their illness and its treatment, about the researcher's opinion of the medical care they are receiving, or about other treatment alternatives that may be available. Participating in research can provide extra contact with "experts", which may be of benefit to participants. The question arises, "Is it ethical to inform prospective research participants of such benefits?". Members of ethics committees may not be comfortable with answering "yes" to this question, because they are likely to be worried about the coercive effect of such information. They may also be concerned about other factors that come into play when the researchers' role is extended to include answering participants' questions. They may be apprehensive about the possible effects on the scientific integrity of the research itself; they may believe that research staff are not the best people to answer questions about the participant's condition; or they may be concerned about role confusion for researchers when they also provide advice.6 In addition to considering how researchers should respond to requests for information, it is important to consider why researchers are being placed in this position at all. It is an indictment of our healthcare system that patients may think they need to take part in research in order to have their needs for information and reassurance met. The study by Scott et al also raises the tricky question of the role of altruism in research participation. Nearly all of the study participants felt that their involvement would benefit others. Researchers may encourage such beliefs, often in the context of explaining that they can not guarantee that the research will benefit the participants themselves. The possibility of benefit to others is sometimes all that can be held out as an incentive for potential participants. Even here, however, things are not that simple. Feeling that others are helped by our involvement in research can be of benefit to us, as concern for our own interests and concern for others' interests are actually closely intertwined.7,8 Sometimes we act altruistically because we enjoy the feeling of being an altruistic person and the positive response it engenders in others. In a sense, our self-interested choices can be re-interpreted as altruistic, and vice versa. In Scott and colleagues' study, feeling that others might benefit from their involvement perhaps offered the participants a way to make sense of difficult and otherwise inexplicable events. Finally, the whole issue of risks, benefits and altruism is further complicated by questions about whose notions of risks, benefits and altruism are to count. Ethics committee members, research participants and researchers are all likely to offer different interpretations of these concepts in specific situations. For example, should ethics committees intervene if research participants choose to believe their involvement will help other people like them if, in fact, there is little evidence that this will occur? Can committee members or researchers accurately judge the risks and benefits of research for a participant, or should the emphasis be principally on facilitating choice? Human emotions and ethics are complicated, and simple statements of risks, benefits and altruistic intent are unlikely to reveal the complexity of the situation. What are ethics committees, researchers and participants (potential and actual) to make of all this? They should, at least, recognise that guidelines are only that, and can never substitute for careful and nuanced consideration of the meanings of terms such as "risk" and "benefit". The NHMRC's Commentary on the national statement on ethical conduct in research involving humans, released this year, provides something of a roadmap in this area.9 But committees will still need skills, knowledge, time and resources to consider these issues thoughtfully. While skills and knowledge may not be in doubt, we know that many committees lack the time and resources needed to do justice to these thorny issues.10

Annette J Braunack-Mayer BMedSci(Hons) PhD

Objective: To investigate family members' experiences of involvement in a previous study (conducted August 1995 to June 1997) following their child's diagnosis with Ewing's sarcoma.Design: Retrospective survey, conducted between 1 November and 30 November 1997, using a postal questionnaire.Participants: Eighty-one of 97 families who had previously completed an in-depth interview as part of a national case–control study of Ewing's sarcoma.Main outcome measures: Participants' views on how participation in the previous study had affected them and what motivated them to participate.Results: Most study participants indicated that taking part in the previous study had been a positive experience. Most (n = 79 [97.5%]) believed their involvement would benefit others and were glad to have participated, despite expecting and finding some parts of the interview to be painful. Parents whose child was still alive at the time of the interview recalled participation as more painful than those whose child had died before the interview. Parents who had completed the interview less than a year before our study recalled it as being more painful than those who had completed it more than a year before.Conclusions: That people suffering bereavement are generally eager to participate in research and may indeed find it a positive experience is useful information for members of ethics review boards and other "gatekeepers", who frequently need to determine whether studies into sensitive areas should be approved. Such information may also help members of the community to make an informed decision regarding participation in such research.

Debbie A Scott DipNurse, MPH · Frances M Boyle BA(Psych)(Hons), PhD · Christopher J Bain MBBS MPH · Patricia C Valery MD, MPH, PhD

To the Editor: The Victorian Health Records Act 2001 became operational on 1 July 2002. This legislation provides important protection for the individual against misuse of health information through the establishment of Health Privacy Principles. We support the spirit of this legislation, but would like to draw attention to its potential effects on multicentre research and disease surveillance. We recently began a study to estimate the burden of invasive group A streptococcal disease in Victoria. The study involves identification of patients through laboratory notifications, followed by collection of clinical data — a strategy similar to surveillance of notifiable diseases. The study is funded by the National Health and Medical Research Council. We have sought institutional ethics committee approval, and are obtaining individual informed consent from patients. Despite approval from the Human Research Ethics Committee of the Victorian Department of Human Services, concerns arising from the new privacy legislation led most Victorian healthcare institutions to also require approval by their own ethics committees. We have now applied to over 30 separate committees, and the process is not yet complete. This has been an enormous drain on resources, has necessitated our establishing complex administrative procedures, and delayed commencement of the project. Moreover, many committees have required that we pay an application fee of several hundred dollars. Some have been uncertain about the implications of the new legislation for our project, and have requested clarification from the Victorian Health Services Commissioner. Despite these processes, some clinicians we have contacted are unwilling to allow their patients to be approached for fear of breaching privacy legislation. Our protocol is not controversial, and no substantive issues have been raised by any of the ethics committees. While ethical clearance is crucial to the success of the project, we were unprepared for the amount of work, confusion and expense involved. It is possible that these difficulties could discourage other researchers from conducting similar studies in Victoria. Similar concerns have been raised in the United Kingdom since the introduction of new privacy laws.1 The Victorian legislation allows for research and surveillance activities using identifying data if they are in the public interest, or if it is impracticable to seek individual consent. However, the legislation does not provide guidelines on what constitutes public interest or when consent is impracticable. The extent to which this legislation affects multicentre research or surveillance projects needs to be clarified, and a more simplified ethical approval process for surveillance activities identified.

Jonathan R Carapetis · Jonathon W Passmore · Kerry Ann O'Grady

Comment: It is unfortunate that a valuable research project has apparently been made more difficult or delayed by the combination of complex new privacy law and longer-standing inefficiencies in the ethical review of multicentre research proposals. Both are issues with which the Australian Health Ethics Committee (AHEC) is grappling at present. Multicentre research was identified as a significant issue in the review that led to the revised 1999 National Statement on Ethical Conduct in Research Involving Humans.1 The Statement makes it clear that researchers have a role in negotiating with human research ethics committees and institutions to seek agreement that the ethical and scientific assessment of one committee or institution will be accepted by other sites. The National Statement equally empowers ethics committees to minimise unnecessary duplication. Ethics committees have been very slow to grasp the opportunities offered by the 1999 National Statement for reasons that may include the past practice of insisting that each committee make its own assessment. Initiatives are now in train in New South Wales, Victoria, Western Australia and Queensland to develop different forms of centralised assessment, but the benefits may take time to be realised. AHEC, through its bulletins and workshops for ethics committee members, has repeatedly reminded committees how to simplify multicentre review, but traditional practices appear to have obstructed this message. This letter is yet another opportunity to remind ethics committees and institutions that the National Statement permits and encourages them to exercise initiative, judgement and common sense in facilitating effective and timely review of multicentre research. With regard to the difficulties associated with the new privacy regimes being put in place by a combination of federal and State laws, AHEC anticipated some introductory problems in relation to human research. It is understandable that ethics committees and researchers will take time to adjust some of their established practices to comply with the law and associated guidelines. During the period of adjustment, some flexibility needs to be exercised by all parties. AHEC conducted a series of workshops in all capital cities earlier this year to assist researchers and ethics committees in this phase. An explanatory guide to the use of privacy law and the associated guidelines from the National Health and Medical Research Council was used at these workshops and will be made more widely available shortly. Finally, the federal legislation will be the subject of a systematic review after two years. Unintended consequences of the law should be addressed at that time. AHEC understands that, in Victoria, the Health Services Commissioner, whose office has responsibilty for supervising the application of the health privacy law, is in the process of producing a practical guide for Victorian healthcare researchers.

Kerry J Breen · Sandra M Hacker

Comment: As I understand Carapetis et al's study, the researchers determine who has a group A streptococcal infection from the laboratory that performs the test (as this infection is not a notifiable disease,1 there is no central source of information). The laboratory may be independent or in a public or private hospital, and may be situated anywhere in Victoria. The laboratory tells them who requested the test and the patient's name and infection status. The researchers then seek assistance from the hospital or doctor requesting the test in obtaining "individual informed consent" from the patient to release clinical information to the researchers. Each institution has required that its own human research ethics committee approve the project, as well as the Department of Human Services (DHS) Ethics Committee, before the laboratory releases information. This accords with the law, but the additional bureaucracy and costs involved will deter much important public health research. The law: In Victoria, public and private hospitals and their employees have a statutory duty of confidentiality under section 141 of the Health Services Act 1988 (Vic). There is an exception when the patient consents (s 141(3)(a)), but, in Carapetis et al's study, patients cannot be approached until the laboratory gives identifying information. Information may be divulged for medical research without patient consent if an ethics committee "established under the by-laws of the agency" has approved "the use to which the information will be put and the research methodology" (s 141(3)(g)). The giving of information must also accord with Health Privacy Principle (HPP) 2.2(g) in the Health Records Act 2001 (Vic): it must be necessary and "in the public interest"; it is impracticable to seek consent; identifying information is needed; identifying information will not be published; and it must conform with the Guidelines of the Health Services Commissioner.2 The federal Privacy Act 1988 (Cwlth) contains similar provisions.3 Options for change: The Health Services Commissioner has power to issue guidelines varying the subparagraphs of HPP 2, and even to lessen the level of privacy protection, if it is in the public interest to do so.4 However, guidelines cannot override the requirement in the Health Services Act that projects must be approved by the ethics committee "established under the by-laws of [each] agency". There are four options for change: The Health Services Act could be amended so that approval of one human research ethics committee is sufficient. The Secretary of the DHS could prescribe more diseases as notifiable,1 so that information is available centrally, and access could be authorised by the DHS Ethics Committee. The Secretary could request information from pathology laboratories for public health research and supply that to the researchers (laboratories would be protected under section 137 of the Health Act 1958 [Vic]). Institutions could amend their by-laws — or ethics committees could adopt a policy — that the institution will follow the approval of the DHS Ethics Committee in public health research.5 The last seems the simplest option, but historically this approach has not been favoured in multicentre trials in Australia.

Loane LC Skene

To the Editor: According to the article by Kennedy in the Journal,1 we failed to address the objections to the RARE SALAMI trial (the Royal North Shore and Ambulance Regional Study of a Stenting Strategy as an Alternative to Lytic/Medical Therapy in Acute Myocardial Infarction) in our account of the fate of this trial.2 Allegedly, we contravened standard advice regarding emergency cardiac care ("to attend the nearest hospital emergency department as quickly as possible").1 However, the standard advice is to call an ambulance,3 not to go to hospital by private transport. Kennedy also claimed that the trial would interfere with " . . . established therapeutic networks and ongoing therapeutic relationships, including relationships with hospitals".1 The reason we ignored such objections was that the wellbeing of networks seemed unimportant in comparison with the welfare of patients with life-threatening illness. The issue of the risk to patients of transport time and treatment delays with the new strategy was also raised,1 but Kennedy did not challenge the actual measured delays or other published evidence we referred to.2 These suggested that mortality was likely to be reduced with the RARE SALAMI strategy. Without reference to published data, he quoted the opinions of clinicians and a municipal council to support the opposite conclusion. The northern suburbs of Sydney are not so remote or exotic that opinion based on knowledge of the "local practicalities" he referred to1 would outweigh the evidence of published data. We argued that complexities of treatments, patients' condition and the pressure of time precluded fully informed consent.2 Allegedly, established guidelines were breached.1 However, the ethics committee, well aware of these, waived conventional informed consent after careful deliberation. A new area ethics committee, constituted subsequently,2 concurred with this decision. Now, in the light of new evidence, the RARE SALAMI trial, as originally proposed five years ago, can no longer be done. The recently presented DANAMI II study4 randomised 1129 patients to treatment with fibrinolysis at local hospitals or to transportation to angioplasty centres up to 153 km away. Transport was found to be safe, and angioplasty was associated with a 40% reduction in adverse outcomes. Field triage was not tested. However, we believe the results of the DANAMI II study now preclude randomisation of 50% of patients with suspected acute myocardial infarction presenting to the Ambulance Service (and eligible for the RARE SALAMI trial) to treatment at district hospitals. Ironically, in northern Sydney, status quo reigns and 100% of trial-eligible patients are taken to district hospitals and delays in achieving reperfusion persist! Thiemann, in a recent editorial, concluded that accrued evidence now favours treatment of patients with acute myocardial infarction in a few high-volume centralised angioplasty centres,5 and that field triage and direct transport to such centres holds great promise. He also deplored the lack of research into system changes and the economic self-interest that, he believed, had stymied change in the United States. Opposition to the RARE SALAMI trial was altruistic.6 However, it nevertheless stopped much needed research and hence may have compromised patients' rights to optimal care.

Helge H Rasmussen · Peter S Hansen · Gregory I C Nelson

In reply: Rasmussen, Hansen and Nelson have missed the entire thrust of my article.1 When an individual calls a health professional for help, we can assume he or she agrees to standard treatment, but not to be placed into an experiment. Failure to inform patients that they are being placed into an experiment is a denial of basic human rights. I outlined a mechanism by which it would be possible to conduct an experiment such as RARE SALAMI that would comply with the appropriate guidelines and avoid denial of informed consent. It is worth noting that failure to inform patients that they have been placed in a clinical experiment could also worsen our present medical indemnity crisis and lower the standing of medical research. It has been shown how institutional ethics committees can be subjected to local pressures.2 As a result, it is possible some may adopt pseudolegalistic interpretations of accepted guidelines and approve studies that would be rejected elsewhere. This is another reason why informed consent is so important. Without it some studies simply can't be done.

Michael C Kennedy

In reply: Aroney's letter raises a number of important issues. The first of these is the question of whether a scientific fact requires the blessing of peer review to become established as such. The corollary of this is whether or not all peer-reviewed facts are necessarily true. The answer to both questions is probably no. The second issue is how to control a media report, irrespective of whether it is based on a peer-reviewed study. The issue which concerns Aroney is an abstract presentation of the association of gastrointestinal bleeding with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) and cyclo-oxygenase II (COX-II) inhibitors, the conclusion of which was that, while the last two might be important in their own right, concurrent use of aspirin, even in a small dose, was more closely associated with bleeding risk, particularly if there was a past history of peptic ulceration.1 A "meta-analysis" of the media reports, which included both television and radio in addition to the quoted report in the Sydney Morning Herald,2 would have made it clear that the theme of the interviews reaffirmed the relative safety of aspirin in the vast majority of individuals, and highlighted the risk of aspirin use concurrently with NSAIDs and COX-II inhibitors, particularly when there is a history of past ulceration. The fact that the SMH report focused on one aspect of the study was counterbalanced by the others. We do not know how journalistic reporting is controlled. A primary question is whether or not aspirin is an effective agent for the prevention of cardiovascular disease beyond the management of acute myocardial infarction. More recent literature than that quoted by Aroney is now questioning the overall cardioprotective value of aspirin.3 This showed that aspirin given as prophylaxis against cardiovascular disease increased the risk of sudden death in every secondary prevention study and left the overall rate of myocardial infarction unchanged.4 Aspirin consistently failed to reduce overall mortality in every study of long-term prophylaxis after myocardial infarction, and in all but one after stroke.3 Furthermore, Cleland and colleagues have argued that a series of meta-analyses, which most people have accepted as proof of the efficacy of aspirin, are of doubtful validity.4 They questioned whether it is appropriate for the medical community to invest so much time and effort in prescribing aspirin and dealing with the adverse consequences of its long-term ingestion to the neglect of other, better proven and apparently more effective therapies such as angiotensin-converting enzyme inhibitors, β-blockers, and statins. At the very least, it can be said that there is controversy in the cardiovascular literature about the benefits of aspirin. Just as important is the issue of the safety of long-term aspirin use for cardioprotection. A recent multidisciplinary expert statement on NSAIDs concluded that, on current evidence, prophylactic use of aspirin should be reserved for patients with established vascular disease, because in other patients bleeding risks may outweigh cardiovascular benefit.5 A Danish study showed that 100–150 mg of aspirin daily increased the risk of haematemesis by a factor of 2.6, with no difference in the risk between enteric and non-coated product; when combined with an NSAID the risk was increased by a factor of 5.6.6 The authors concluded that the bleeding risk may offset some of the benefits of aspirin. It is no longer appropriate to simply "bury" the adverse gastrointestinal effects of low-dose aspirin in the NSAID side-effect "basket".7 It is apparent to us that dogma should not be so enshrined that it prevents the discussion of issues that might helpfully modify that dogma.

Terry D Bolin · James V Bertouch MD

In reply: The letter from Aroney displays some basic misunderstandings of the role of the media in reporting medical issues. Aroney states that "the press [has] a responsibility . . . to avoid recommendations which are not evidence-based and which detract from our efforts to reduce mortality from . . . cardiovascular disease." A press article does not itself make recommendations when it reports the recommendations of others — an essential distinction. In addition, the press has no responsibility to follow the agenda of the medical profession and its slavish insistence on the dogma of evidence-based medicine. The press owes doctors no more favours than it owes any other sector of the community. The role of the press is to raise and debate issues of public interest in a manner that is balanced and responsible. The news report about aspirin did all of this.1 We agree that publication in a peer-reviewed journal may add scientific credibility to research findings and that this may sometimes make them more newsworthy. But our responsibility is to report medical matters of interest to the community, which means we are not limited to peer-reviewed findings. Any substantial fact, observation or opinion relating to medical practice is fair game for a newspaper's attention. After the findings of Bertouch and colleagues were presented at a conference,2 they entered the public domain, as did their later comments made to us directly. It was entirely proper to report them. The fact that the gastrointestinal bleeding study was conducted by two heads of department at a major Sydney teaching hospital was instrumental to our decision to position and headline the report prominently. These individuals are respected experts in their fields, and they expressed to us serious concern about the degree to which aspirin was implicated in gut haemorrhage. It was that concern which led us to focus on the aspirin findings within the broader study. The news process is always selective and there is no obligation to give equal emphasis to all findings. The magnitude of follow-up by other media confirms the inherent public interest in the topic. It has previously been suggested that medical journalists are behaving irresponsibly when they step outside the strictures of peer review.3,4 Yet it is a basic tenet of journalistic ethics that journalists should be independent.5 Why, then, would we subscribe to the doctrine of evidence-based medicine, with all its flaws? We, and the community, have every right to be sceptical of the tyranny of peer review when the pharmaceutical industry manifestly uses financial muscle to influence what is studied and what is published.6 Even the Medical Journal of Australia accepts anecdotal findings when it can persuade itself the public interest is involved, recently publishing an eyewitness account of conditions inside an immigration detention centre7 and defending this on the basis that "our readership is sophisticated enough to interpret the content of such articles."8 Sydney Morning Herald readers are also sophisticated. On what basis should they have been denied this pertinent information about a widely used medicine — that doctor still knows best?

Julie Robotham BA(Oxon) · Robert Whitehead

In this issue of the Journal, Loke and colleagues (page 291) present data from an analysis of 174 advertisements for pharmaceuticals appearing in six Australian medical publications.1 The findings are striking enough to be restated. Fewer than 8% of the advertisements contained quantitative data about the outcomes of therapy, and most of these framed the information in relative rather than absolute terms. Only 28% of the therapeutic claims in the advertisements conveyed clinical outcomes in any specific, substantive and unambiguous way. In the United States, pharmaceutical advertising is subject to the Federal Food, Drug, and Cosmetic Act,2 and Loke et al suggest that, in Australia, advertisements for drugs may be less informative than in the US. The pharmaceutical industry has long maintained that drug advertisements are an important vehicle for conveying important information about new drugs to prescribers. Is this how industry believes it should communicate with highly trained healthcare professionals? Should we really be surprised by the results of Loke et al, and, more importantly, should we be concerned? We know that the pharmaceutical industry spends enormous sums on promoting its products (about twice the amount spent on research and development),3 but most data on the effect of advertising on prescribing are unpublished, and have been gathered by advertising companies. The Association of Medical Publishers (AMP), a US-based organisation whose membership includes the publishers of nearly 200 biomedical journals, boasts "advertising in medical publications alone... can generate sales for both new and more-established products" [original emphasis].4 AMP reports a number of studies that have shown a significant increase in market share and retail sales as a result of medical journal advertising, which is reported to provide a return on investment (ROI) of about US$5.00 for every dollar spent, greater than detailing (ROI US$1.72) and direct-to-consumer advertising (ROI US$0.19).5 Most advertisements are for new and expensive drugs, so increased use due to promotion will contribute to the financial pressures on the Pharmaceutical Benefits Scheme (PBS). Does journal advertising also lead to inappropriate practices? Although there is a substantial body of research on the effects of pharmaceutical industry promotion generally, relatively little involves printed advertisements in medical journals. In a landmark study, Avorn and colleagues studied physicians' beliefs about the efficacy of two classes of drugs (propoxyphene analgesics and central/peripheral vasodilators) that were being heavily promoted as effective, despite evidence that they lacked any efficacy and offered no advantages over existing treatments.6 The authors found that, even though doctors reported paying little attention to drug advertisements, most doctors believed that these agents were effective. Do the results reported by Loke and colleagues have other implications? What is their relevance for the development of government policy? The Australian Competition and Consumer Commission (ACCC) is currently examining an application for reauthorisation of the Code of Conduct of the Australian Pharmaceutical Manufacturers' Association (now Medicines Australia). As part of the examination of the relationships between pharmaceutical industry participants, the ACCC is investigating claims in the media about some practices and whether they are in the best interests of the community (Lin Enright, Director, Public Relations, ACCC, personal communication). The ACCC should heed the results reported here. It is only two years since the review of direct-to-consumer advertising of pharmaceutical products in Australia.7 Although the review recommended against direct-to-consumer advertising, the subject is under continuing review, and some within the pharmaceutical industry are still pressing for change, maintaining that such a facility would enable them to provide important educational information about drugs to the public. Similar moves to relax laws relating to direct-to-consumer advertising are also occurring in Europe and Canada.8 The information reported by Loke et al on journal advertisements suggests that direct-to-consumer advertising is likely to be uninformative and promotional rather than educational in nature. Where should we look for guidance on appropriate standards for advertising pharmaceutical products? Medicines Australia polices a voluntary code of conduct that aims to set "standards of conduct for the activities of companies when engaged in the marketing of prescription products".9 This document places more emphasis on what not to do when promoting medicines, rather than offering guidance on how to provide balanced advice to clinicians about the efficacy and safety of medicines. Perhaps we should pay more attention to the advertising standards maintained in other industries. Generally, advertisements for technologically sophisticated products include prominent displays of their specifications, performance and selling price. Is it too much to ask that advertisements for modern drugs provide similar information? In an era of evidence-based medicine this should include data on the absolute effects of therapy, such as the response rates with and without treatment, and the number needed to treat, in order to avoid the ambiguities of relative measures such as the relative risk reduction. It would be best if this information related to comparisons with established therapies, not just placebo. Clinicians should also be told the dispensed price of the drug under the Pharmaceutical Benefits Scheme.

David A Newby BPharm, PhD · David A Henry MRCP, FRCP

Objective: To determine the quality of claims in advertisements published in Australian medical publications, describe how benefits and harms are presented, and examine the level of underpinning evidence.Design and setting: Audit of a consecutive three-month sample of advertisements appearing in six popular Australian medical publications.Main outcome measures: Proportion of advertisements with quantitative information; proportion of claims conveying clinical outcomes; where retrievable, level of underpinning evidence.Results: Of 1504 claims, 855 could be substantiated quantitatively. Of these, 45% were supported by compelling evidence (randomised controlled trials or better). Of 13 claims explicitly reporting quantitative outcomes, none provided the absolute risk reduction or the number needed to treat.Conclusions: Our audit invites greater diligence by pharmaceutical companies in substantiating their claims and greater vigilance among clinicians when reading them.

Tim W Loke MB BS(Hons) · Fong Chee Koh MB BS(Hons) · Jeanette E Ward PhD, FAFPHM

"Humanistic medicine" is a term compounded, for therapeutic purposes, with the good intent of reminding clinicians of their need to be compassionate and empathic. Although the expression is arresting, and demands thought, it does not go far enough. "Values-based medicine" is a stronger term, reminding clinicians of the sustaining values that underpin the whole health endeavour. These values include an acceptance of the value of individual human life in quantity and quality, and of the importance to both individuals and communities of human security and flourishing. Values-based medicine can incorporate all the other paradigms of medicine, including scientific and evidence-based medicine, within it, because it can include anything that contributes to human security and flourishing. If we are to seek a new paradigm for a reconstructed view of healthcare, the term "values-based medicine" might have more power and relevance than "humanistic medicine".

J Miles Little MD, MS

On 8 July 2002, the National Health and Medical Research Council released a discussion paper1 and draft guidelines for xenotransplantation research, with the aim of promoting widespread community debate of the issues involved. In the discussion paper, xenotransplantation is defined as the placement of animal cells, tissues or organs into humans, and includes the exposure of human tissue or cells to animal cells. Examples include the external perfusion of blood through a "bioartificial liver" (ie, an external apparatus containing pig liver cells which are separated from the perfused human blood by a semipermeable membrane), or culture of human skin cells on mouse fibroblasts for later use in treating burns. This definition excludes implantation of inert, sterilised animal tissues, as currently used to create artificial heart valves. The concept of xenotransplantation has arisen because of an ongoing shortage of human donor organs. The discussion paper provides information on this shortfall, and measures pursued in Australia and overseas to try to improve organ donation rates. As there is general acceptance that the demand for donor organs is such that even increased human donation will not overcome the problem, the complex issues attending the shortage of human donors are not pursued further in the discussion paper. So, what are some of the matters requiring community consideration and debate? A key issue is the risk that an infectious agent could cross from an animal to humans, and produce unknown infectious risks for the general community. Cross-species transmission of most known viral and bacterial pathogens is preventable by appropriate breeding, housing and testing of source animals. However, there is serious concern that a virus, such as the endogenous retrovirus present in the pig genome (the pig is currently the preferred source of organs), could "reactivate" in human recipients and, theoretically, later infect close contacts, healthcare workers or the wider community. Although experimental work has demonstrated that isolated human cell lines can be infected with porcine endogenous retrovirus (PERV), retrospective testing of 160 patients exposed to date to pig xenotransplants, such as islet cells or neural cells, or to external perfusion using pig liver cells, has not revealed evidence of PERV infection.2 This risk of infection brings a new ethical dimension to how consent for xenotransplantation research might be given. The discussion paper emphasises that not only will any potential recipient need to be fully informed of any risks, but so too will close contacts of the recipient and members of the healthcare team. An additional ethical issue relates to how a prospective recipient might reasonably choose between risking an experimental therapy or waiting for a human organ transplant. Another issue which requires community debate is the potential use of genetically modified pigs to overcome the intense rejection reaction which, so far, has made xenotransplantation unfeasible. While experimental work to date has involved minimal genetic manipulation, more extensive modification (which could be seen to significantly alter the essential nature of the animal) may not be acceptable ethically or to our community. In all human research, a key ethical principle is that the putative benefits must outweigh the known and theoretical risks. Weighing this balance for any human xenotransplantation research proposal will not be an easy task. The draft guidelines outline multiple conditions which must be met before research can be approved. One such requirement is obtaining convincing data of the efficacy of animal-to-animal experiments (eg, pig-to-baboon xenotransplantation) before pig-to-human trials can be contemplated. A further issue relates to which group of individuals should be empowered to weigh up these benefits and risks and give approval for such human research on the community's behalf. The discussion paper recommends that this should be a task for a national committee, whose membership would include people with relevant scientific, ethical and regulatory expertise, as well as community members. Local human research ethics committees would play a role in monitoring the research, and could reject a proposal, but could not approve a proposal unless it had also received approval from the national committee. The full text of the document, entitled Draft guidelines and discussion paper on xenotransplantation, is available on the National Health and Medical Research Council (NHMRC) website,1 or can be obtained from the NHMRC at PO Box 9848, Canberra, ACT 2601. The document contains advice on how to make a submission by the closing date of 6 September 2002. Submissions will be carefully considered by the working party in making its final recommendations to the Council. The NHMRC regards xenotransplantation research as one of the more important issues for community consideration, and wishes to actively involve medical practitioners in the debate. Medical practitioners are invited to either develop and communicate their own views, or to assist in stimulating debate in the wider community.

Kerry J Breen, on behalf of the NHMRC Working Party on Xenotransplantation MD, FRACP

To the Editor: The study by Douglas et al1 reports that the purposeful hastening of death in terminal illness is both widely practised and an acceptable method of palliative care for over a third of Australian surgeons. Yet the study is based on a questionnaire strongly favouring theoretical scenarios rather than actual practice. The framing of the questions maximises reporting bias towards "hastening death" by the use of absolute terms (eg, "Have you ever . . .?"; "[Are] there any circumstances . . .?"1). The study also fails to determine the stage in a terminal illness at which hastening of death had been, or might possibly be, acceptable to the surgeons, nor the reason for its implementation. If the patient's symptoms are already adequately controlled and the dying process is not prolonged, we do not see why it is necessary to administer doses in excess of those required to control symptoms. Whose symptoms are we treating?

Mathew Piercy · Gerald B Fogarty · Aubrey W Jansz · David M Gawler · Luis Vitetta · David Kenner · Avni Sali

To the Editor: We wish to comment on the article by Douglas et al about surgeons hastening death.1 Recently, Ray2 noted that, historically, surgeons have had to witness their patients' pain probably longer than any other medical specialty. Hence, it is not surprising to read Douglas and colleagues' report1 that more than a third of surgeons surveyed performed life-terminating events without explicit and persistent requests. The desire for death, as perceived by doctors and patients, has been correlated with ratings of pain, depression and poor family support.3,4 Surgeons, while intending "no harm", could be seen to be palliating themselves (relieving their own distress) as well as their patients' when performing life-terminating events. Helplessness, hopelessness and negative attitudes toward life-sustaining treatments are common and understandable in palliative care, and experienced by both doctors and patients.3,4 Surgeons are relatively new to palliative care and could have a significant contribution to make to the psychosocial support of cancer patients with terminal illness. Decisions by surgeons about hastening death may be modified by greater interaction with their patients' families and with other healthcare providers working with terminally ill patients. A clinical-outcomes study of 102 consecutive deaths of terminally ill patients admitted to hospice care during 1997–1999 highlights the importance of family support in the outcomes immediately before death.5 The study period coincided with a time of heightened awareness of euthanasia in Australia. Fifty-six per cent of the patients had received continuous family support and 44% sporadic support; these patients appeared to have less distress and better preterminal outcomes, despite 10% experiencing significant family conflict and distress. However, no spontaneous or other requests for euthanasia were recorded in patient files or notes by staff. This could reflect, in part, family support received in an environment conducive to positive interactions between patients, their families and health professionals. Involving such palliative care teams in surgeons' care for terminally ill patients may have a significant effect on both pre-terminal outcomes and hence requests for euthanasia.

Mathew Piercy MB BS · Gerald B Fogarty BSc, MB BS(Hons) · Aubrey W Jansz MB BS, FRACS · David M Gawler MB BS, FRACS, FRCS · Luis Vitetta · Avni Sali Professor and · David Kenner

Three articles in the Christmas issue of the Journal,1-3 responding to media coverage of a proposed clinical trial,4 failed to address the objections raised to conducting the trial without patient consent. The proposed trial, the Royal North Shore (RNSH) and Ambulance Regional Study of a Stenting Strategy as an Alternative to Lytic/Medical Therapy in Acute Myocardial Infarction (RARE SALAMI), was to be conducted in Sydney's Northern Area Health Service. The aim was to compare two regimens of management of patients with acute myocardial infarction and determine whether, despite some additional transit time, diverting ambulances past local hospitals (where patients would receive thrombolytic treatment) and on to the services at RNSH (where patients would be treated with percutaneous coronary intervention) would be beneficial to patients (Box 1).1 The trial would involve the ambulance service, RNSH and the emergency departments of four district hospitals within the health area. Senior medical staff from two of the emergency departments were among those who expressed concerns in the media reports.4 Diversions from standard treatmentInherent in the trial were a number of diversions from standard treatment and procedures. These included contravening the standard advice provided to the community regarding emergency cardiac care — to attend the nearest hospital emergency department as quickly as possible; interference in established therapeutic networks and ongoing therapeutic relationships, including relationships with hospitals; and, most importantly, delays in time to treatment. Delays in time to treatment were to be caused by: Performing a resting 12-lead electrocardiogram (ECG) at the point of ambulance pick-up of patients with cardiac symptoms for the purpose of the selection and allocation of trial subjects; Informing the allocating person at the ambulance control centre of the computer report of the ECG and awaiting randomisation; Transport of subjects randomised to the experimental group past hospitals with facilities for thrombolytic treatment and a private tertiary hospital providing acute invasive cardiac procedures, thereby adding up to about 40 km of suburban roads to the emergency dash. Adding uncontrolled clinical variables (eg, intercurrent illnesses) and location difficulties caused by heavy traffic at peak periods, a lift bridge and intermittent road closures due to environmental hazards (eg, low-level flooding, bushfires). Opposition to the trialIt was evident from all the MJA articles that many people within the profession and in the community opposed the trial. There are several reasons for this opposition, including: local geographical issues of transport and the present distribution of health services; issues of risk and inconvenience for patients; methodological issues such as experimental design, rationale and execution of the trial; and no provision for meaningful consent before entry into the trial.1-4 Despite this opposition, at the time of the media investigation the trial was about to be implemented. Members of the community and hospital and ambulance staff not wanting to be involved in the trial were about to be included. Indeed, in the period between the media reports and the Christmas issue of the MJA, one metropolitan council included in the trial area formally documented its view in relation to the proposed trial and conveyed this to the relevant ethics committee.5 The following motion was carried unanimously: Council opposes the conducting of medical trials on any member of the community without their full informed consent — this particularly applies in the treatment of cardiac conditions. Patient consentIn the MJA articles it was proposed that "ethics committees (can) assume the responsibility of giving consent on behalf of patients",1 and that, "almost by definition, people in the midst of life-threatening medical emergencies, who may be unconscious, in shock, in extreme pain or delirious, surrender their normal sentient ability to consent".2 However, this denies one of the cornerstones of medical ethics — the patient's right to self-determination. This is not to say that clinical trials should be discarded. Experimenting on patients, often in the form of a clinical trial, is an essential element of evaluating drugs and therapeutic innovations. Patients are patients because they present for and need treatment. They are entitled to a treatment that is tried and true — in this case, standard rescue protocols for myocardial infarction — and, unless otherwise indicated, they must reasonably trust that that is what they are getting. Accordingly, medical staff and, in this case, ambulance personnel are obliged to provide such care. Service organisations and clinician-researchers may experience tension between their obligation to provide a certain type of treatment and the need to divert from accepted standards for research purposes. Fortunately, there are guidelines to ease this tension and to chart the correct course of action. The Nuremberg Code of 19476 is the modern forerunner of these guidelines. It has the appeal of being a simple 10-point code and, until 1964, when the World Medical Association (WMO) produced its first set of guidelines (the Declaration of Helsinki), was the only code of its kind. Subsequently, there have been revisions of the WMO's Declaration7 and the development of various national codes, including the Australian National Health and Medical Research Council (NHMRC) statement on research involving humans. The NHMRC's 1999 National Statement8 is currently the primary guide to clinical research in Australia. As with other guides, it emphasises the importance of fully informed consent and sets out the circumstances in which patients can be included in clinical trials without their knowledge or consent. Criteria for proceeding without consentConsent is reviewed in considerable detail in the NHMRC Statement on Ethical Conduct in Research Involving Humans.8 Statements relating to areas where consent is either waived or considered not necessary appear in paragraphs 1.11, 6.9, 14.4, 15.8, 16.13 and 17.1 and 17.2. Paragraphs 14.4, 15.8 and 16.13 relate to identifiable data, tissue samples and genetic issues. Interestingly, even in survey-type activities where consent is not required, Part 17 ensures there should be no element of deception. Part 6 considers emergencies, intensive care, terminal care, those with impaired capacity for communication, those highly dependent on care, and the unconscious (see summary in Box 2). In relation to emergency situations, the vulnerability of patients and relatives is acknowledged, as is the inability to obtain consent. When research may produce a ". . . reduction of potential benefits", Part 6.9 gives specific guidance, stating that the research should not be contrary to the patient's interests; must be based on valid scientific hypotheses; must ensure that the patient/relatives are able to give consent or withdraw the patient from the research as soon as reasonably possible; and, most importantly, must ensure that there is no increased risk to the individual. Leeway has been allowed for proceeding with experimental techniques without consent when a number of the conditions are met. The essence of these can be summarised as follows: The choice is between essentially no treatment and experimental treatment; The experimental treatment offers the chance of benefit and no greater harm; and There are reasonable grounds for assuming that the patient would consent if he or she were able to. Similar leeway has been allowed by the Food and Drug Administration (FDA) in the United States. The FDA undertook review of this area in response to concerns expressed by researchers that ". . . current rules are making high quality acute care research difficult or impossible to carry out when the need for such research is increasingly recognized". As a result, regulation 50.24 became effective in 1996.9 These guidelines are summarised in Box 3. While institutional ethics committees may interpret the FDA guidelines differently for specific treatments,10 the circumstances that allow waiver of consent in emergency situations are similar to those outlined by the NHMRC. They include proceeding with acute resuscitation that is experimental at the time of a cardiac arrest when standard treatment has failed; trialling the acute use of a neuroprotective agent when a patient arrives in the emergency department in a deeply comatose state; or, as recently reported, the administration of standard anticonvulsants by ambulance personnel.11 Will patients be harmed?The downside of any clinical experiment is that the hypotheses may turn out to be wrong and patients may be harmed. The RARE SALAMI trial requires delaying accepted efficacious cardiac treatment in emergency situations in which there is a very high mortality rate in the first hours. The hypothesis that no harm will be done to the patients is put forward in one of the articles as a foregone conclusion,1 but doctors with a working knowledge of local practicalities of the catchment area were clearly not convinced by these arguments,4 and neither were the intended research subjects, their representatives and statutory authorities, who were moved to formalise concerns.1,5 Such situations are succinctly covered in the Nuremberg Code. Point 5 states: No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. ConclusionsKomesaroff is correct in stating that this imbroglio provides several important lessons about process.3 In addition, it is a reminder of the need to guard against confusing "consent to treatment" with "consent to research", and to avoid distorting what the guidelines say. This applies particularly to what the NHMRC National Statement says about consent for research in persons highly dependent on medical care. Finally, it is most important to remember what calling an ambulance is all about. With regard to consent, the trial cannot be imposed on an unwilling community and unwilling doctors. It should not proceed until the following conditions are met: 1. At the community level There is factual agreement between the researchers and the community as to the time delays involved; There is broad agreement within the profession as to the risk to patients; There is agreement between researchers and the local community, including local general practitioners and specialists, as to the disruptions that would be caused by the trial; Arrangements are in place to detect and make good any harms caused; and The community agrees that the benefits of the project to their community are worth the costs to the community. 2. At the level of individual research subjects All persons in the communities involved with the trial have been informed of the details of the proposal, including the risks and benefits to research subjects, by means of mailing and public meetings, and their comprehension of the information has been established by a survey; and There are provisions for opting out and confirmation of informed consent at the point of first contact by ambulance personnel. This is informed consent in action. Without it, some experiments simply cannot be done. 1: Proposed sequence of events for a trial to compare two regimens of management for acute myocardial infarction 2: Summary of National Health and Medical Research Council guidelines for research without consent Paragraph 1.7 If a participant lacks competence to consent, a person with lawful authority is provided with the information and exercises that choice. Paragraph 6.9 When conformity to the principle of consent (paragraph 1.7) is not feasible, and neither the participant nor the individual's representative can give consent in advance, a Human Research Ethics Committee may approve a research project without prior consent provided the proposal (a) is not contrary to the patient's interest; (b) does not place the patient at any more risk than that which is inherent in the patient's condition; (c) is based on a valid hypothesis; and (d) the patient, the patient's relatives and legal representatives will be informed as soon as possible and given the choice to continue the experiment or withdraw the patient. 3: Summary of FDA Guidelines for research without consent 1. Life-threatening situation, available treatments unproven or unsatisfactory and an experiment, including the use of placebo, is needed to answer the question. 2. Consent not feasible because (a) of the medical condition, (b) it must be administered before an authorised person can give consent, (c) it is not possible to identify subjects before the condition occurs. 3. Subjects may benefit because (a) they are in a life-threatening situation, (b) animal or preclinical studies show the potential for benefit, (c) the risks are reasonable allowing for what is known about the condition. 4. The study could not be conducted without a waiver. 5. The time window for the experimental intervention is defined and during this time the investigator is committed to finding the subject's duly authorised representative rather than proceeding without consent. 6. Community consultation before the study to explain risks and expected benefits. 7. Public disclosure of the results. 8. Independent monitoring of the results. 9. The subjects (or their representatives) are informed as soon as possible as to their inclusion in the study.

Michael C Kennedy MD, FRACP

To the Editor: Recent astronomic awards for medical mishaps, and the follow-on medical indemnity crisis, bring back memories of an earlier editorial I wrote for the Journal dealing with some aspects of this problem. Its message is worth repeating. In 1990, a letter by Armstrong was published in the Journal,1 which enclosed a newspaper advertisement for a firm of solicitors, Messrs Stern, Stern & Tanner, inviting custom from anyone who may have been a victim of "obstetric negligence", "even if your child was born as long ago as 1965 or even earlier. Initial consultation free". The Journal's then editor invited me to write an accompanying editorial. The editorial, published simultaneously with Armstrong's letter and accompanying advertisement, was headed "No hawkers, canvassers or solicitors".2 It began with a quotation from United States Chief Justice Burger: "Never, never, never under any circumstances hire an advertising lawyer!".3 It noted that some solicitors claimed to possess special expertise in asbestos-related diseases, others claimed to know all about defoliants. I suggested, in those innocent days, that "obstetric negligence" was a new subspecialty which should henceforth be known as Stern–Tanner disease. (If Drs Guillain and Barré were to be forever enshrined in medicine's Hall of Fame, why not Messrs Stern and Tanner?) My editorial suggested a remedial response, stating that "the law permits parties to any contract to abrogate, limit or qualify their legal rights, duties, liabilities and remedies which might otherwise arise. Thus, while the courts — both here and in the United Kingdom — tend to lean against total exclusion from liability, they are, surprisingly, more benevolent towards clauses which limit liability, however contemptuous the specified amount." I adhere to that view. I can see no reason why doctors — save in an emergency — cannot demand that patients enter into a written "contract of treatment" which limits the treating doctor's liability to a specified amount. And while such contracts will not be valid against children born impaired as a result of "obstetric negligence", I can see no reason why the courts should deny the validity of such contracts as a matter of public policy. Why should "contracts of treatment", entered into between consenting adults, be any different from those entered into with lawyers or dry cleaners? It may seem a trifle offensive, but then the practice of medicine is treated in law as a business, much the same as touting lawyers or dry cleaners. If doctors were once put on a pedestal, this pedestal has been effectively knocked down by astronomic awards of damages freely awarded by the courts — whether by judge or jury — largely as a result of the freely expanded constituent elements of the tort of negligence. I researched the law relating to "limitation of liability" clauses, which was published in the Australian Law Journal4 and quoted in the MJA editorial: "Why the courts should be more benevolent to clauses of limitation than to clauses of exemption is not easy to comprehend. . . . The principle, it seems to the present writer, is much the same: Exclusion clauses save a party from having to pay anything, whilst a limitation saves him from having to pay as much as he would otherwise have to pay. [ . . . ] Alas, the last word on this seems to have been spoken for some time to come." As far as I am aware, the law has not changed since the publication of my earlier research.

Paul Gerber