Patients’ rights: from Alder Hey to the Nuremberg Code
Elizabeth T. Hurren |
- Recent historical investigations have revealed that organ research scandals are not new but were common in the late-Victorian era, when many local authorities supplied cadavers of the poor to regional anatomical schools to offset the costs of care in the community.
- Moreover, the recent Alder Hey organ scandal parallels many of the furtive research practices of the late-Victorian medical profession.
- In looking for a way forward, the Nuremberg Code formulated after the Second World War could provide the basis for a new charter of patients' rights in anatomical research.
- And learning the historical lessons could also involve a new culture of openness and inclusiveness currently denied in the pathology field.
Professor Ian Kennedy's report delivered to the independent inquiry into the Bristol heart babies scandal in July 2001, has reiterated the need to redress a 'club culture' amongst powerful but flawed medical researchers in the National Health Service (hereafter NHS). Kennedy noted that there was a 'poisoned' atmosphere between medical staff at Bristol Royal Infirmary, which led to 35 babies under the age of one dying unnecessarily between 1991 and 1995. He spoke of a 'Greek tragedy' of events warning that evidence of malpractice and complacency was 'ignored' at the most senior management level. Any junior member of staff who questioned their superior's procedures or medical decisions was 'threatened' with dismissal by senior colleagues. Parents who demanded an explanation after the death of their child were given only 'partial, confusing and unclear' information. Kennedy concluded that this type of complacency and arrogance was endemic in the NHS. He reiterated that findings from both the Bristol and Liverpool Alder Hey organ scandals highlighted the need to re-examine routine medical procedures. There were 'general failings' throughout the NHS and these were alienating public opinion.
Kennedy's criticisms attracted considerable media attention because several of his most senior medical colleagues expressed similar misgivings earlier this year. Liam Donaldson, the Chief Medical Officer responsible for investigating the Liverpool Alder Hey scandal, announced in February 2001 that 105,000 organs, body parts and foetuses had been retained in 210 English NHS trusts and medical schools. Of those 210, around 25 leading institutions accounted for nearly 90% of the body parts retained. He found that over 16,000 organs had been kept illegally. Michael Redfern QC, who examined Alder Hey pathology practices, found that organs had been stockpiled and then processed as clinical waste between 1970 and 1990. Redfern concluded that there was a 'weak and poorly understood legal framework that allowed bad practice to flourish'. The obscure meaning of the word 'tissue' under the Human Tissue Act (1961) allowed medical researchers to be agents and benefactors of the law. Reiterating these findings, Donald Irvine, President of the UK's General Medical Council (hereafter GMC), pointed out that it was no longer justifiable to apportion blame for these scandals on maverick individuals, such as Prof. Dick van Velzen (the pathologist at the centre of the Alder Hey scandal). Instead it was time to acknowledge that there were 'inherent cultural flaws in the medical profession', which exuded 'excessive paternalism', resulting in a 'lack of respect for patients' giving rise to 'secrecy and complacency about poor practice'.
In response to Prof. Kennedy's criticisms about Bristol Royal Infirmary in July 2001, the Secretary of State for Health pointed to the new guidelines issued by the Royal College of Pathologists in March this year and assured the public that organ donation procedures were currently undergoing extensive public consultation. The problem with such assurances is that there is a long history of both government and the medical profession conducting their 'business' by stealth, so that the general public remains sceptical. This paper argues that it is time for us to look forward to the past - otherwise we cannot understand how the current 'club culture' amongst the medical profession evolved. Nor can we remedy the loopholes, misjudgements and tenor of much nineteenth century medical legislation, which still shapes decision-making today. Past practices facilitated the current medical research controversies. Only when we understand that 'Alder Heys' were common in the late-Victorian period can we begin to re-evaluate the way forward.
The Anatomy Act of 1832
Although the history of medical research in England is complex, most historians concur that the Anatomy Act of 1832 set new guidelines that we have inherited today.
In a recent article in the Lancet (11/3/2000), Ruth Richardson, an expert in this field, points out that the discipline of pathology in particular continues to preserve the ethos of this nineteenth century medical legislation. Under the terms of the 1832 Act any person dying in the care of the community whose family could not afford to bury them had to accept the ignominy of a pauper funeral. This was feared amongst poorer families because it meant that the body could be sold before burial by the parish authorities to regional anatomical teaching schools for medical training and research. After the corpse had been dissected and dismembered each anatomical school was required by law to put all the labelled body parts together in a coffin, conduct a basic Christian service and bury each cadaver in a pauper grave. Recent research indicates that typically six dissected bodies were placed together in a common grave, marked by a numbered wooden cross. Although this process was rational in medical terms, it is worth remembering that the Victorians believed that a pauper funeral was an indication of both social and religious failure. Those whose bodies were dissected and dismembered could not rise from the grave whole on the Day of Judgement. So families with makeshift economies pooled their meagre resources to ensure that at all costs their loved one had a 'decent' burial.
The Anatomy Act of 1832 was, therefore, a distrusted piece of legislation in poorer communities. Although it stipulated that the poor could claim their loved one's body for burial for up to six weeks after death, in practice most had to organise a funeral fund more quickly. For numerous boards of Poor Law guardians sold bodies within a week of death if the body was unclaimed or the family had indicated they might require a pauper funeral. Anatomical teaching schools were always anxious to obtain cadavers soon after death to begin the preservation process immediately. This meant that workhouse personnel were often pressurised into releasing cadavers early to ensure preservation was underway so that the body was ready at the right time during the teaching cycle. In the nineteenth century poorer families who heard rumours about such practices resented the medical profession increasingly. In the past, just as today, many suspected that legislative guidelines were not followed but it was difficult to prove malpractice. Richardson points out that fear of the Anatomy Act resulted in poorer people rioting against its provisions in the decade after its implementation, most notably at Sheffield and Cambridge. The anatomy theatre in Cambridge was ransacked in December 1833 by an angry mob determined to put a stop to the dissection of a man. The mob believed his body had been procured illegally. Although those fears were unsubstantiated in this case, they shaped the general public's response. This wave of popular protest alarmed the medical profession who resolved to hide its activities from the general public. To a greater or lesser extent it has been doing so ever since.
The Local Government Board of 1871
In 1871 a new central body was created to oversee all aspects of local government, namely the Local Government Board. Its remit was vast and complex. Yet, it had one priority - to cut local expenditure and taxation at all costs. In the decade 1860 to 1870 welfare provision distributed by Poor Law Unions had risen nationally by an unprecedented 15% and Treasury officials were determined to cut poor relief expenditure and any customary welfare payments regionally. Forty-one leading Poor Law Unions, containing 16% of the total population in England and Wales, notably Manchester, Liverpool, Oxford, Whitechapel, St-George-in-the-East, Bradfield and Brixworth, were determined to cut costs despite the social implications. In particular, they attacked all forms of customary welfare payments - the children of elderly parents were prosecuted for their relatives' maintenance; private charity schemes were set up to take people off the rates; and regulations were tightened against those assisted on medical grounds. Regional evidence suggests that many poor people experienced greater hardship because of the cost-saving policy. However, a key policy change in 1885 seems to have upset the labouring poor the most. Moreover, in those Poor Law unions leading this cost-saving drive the Medical Relief (Disqualification Removal) Act 1885 changed attitudes to customary funeral payments. They calculated that if they refused all burial applications from impoverished bereaved families living outside the workhouse on medical orders, they could achieve central government's cost-saving targets. This meant that many terminally ill or elderly patients were forced to enter the workhouse. Consequently, when their deceased body was unclaimed by poorer relatives who could not afford a funeral, guardians could sell each cadaver to recover the costs of care in the community.
The late-Victorian medical establishment welcomed the consequences of these funding changes, in the form of an increased supply of cadavers because by 1885 there had been a number of important changes in the training of doctors. In order to pass all medical examinations it was now essential to have two years training in anatomy and more bodies were needed for dissection and dismemberment. Moreover, anatomy schools needed the student fee income because they were not state-funded. Thus the training requirements and economic priorities of the medical profession converged with the desire by central government to cut welfare costs to the detriment of the poorest members of society.
Late-Victorian Alder Heys
A closer examination of the expansion of regional anatomical schools in the late nineteenth century reveals remarkable historical parallels with the recent Alder Hey controversy. Five broad themes emerge.
First, many anatomical teaching schools in the late-Victorian period procured their material by undertaking body-finding drives around English Poor Law unions and asylums. For example, Cambridge anatomical teaching school, in its bid to become a world leader, obtained bodies from as far afield as Brighton, Hull, Leeds, Liverpool, Manchester, and Southampton. In particular, it valued young bodies, especially children and infants. There was virtually a national market in body tissue. Similarly, the Alder Hey controversy arose because of an apparent shortage of research material. This perception came about because some medical researchers aimed to be world leaders in their field of pathology. Thus, a number of coroners and research laboratories used their discretionary powers under the Human Tissue Act (1961) to retain organs and tissue samples without consultation.
Second, in the late-Victorian period many anatomical teaching hospitals paid fees of £1 per cadaver (about the average manual weekly wage) to poor law authorities and asylums which supplied their material, while professors of anatomy also made arrangements with local vicars or priests for their services when bodies were finally disposed of. Most of these bodies came from poorer families, of course. Where research material has been difficult to procure some modern hospitals have continued to pay a small administrative fee to cover costs. This ensures a regular supply of organs. At first, it was thought that this only happened at Alder Hey, where a fee of £5 per cadaver was paid for pituitary glands (used to synthesise human growth hormone). However the Lancet reported in February 2000 that Our Lady's Hospital for Sick Children in Dublin also 'sold' pituitary glands from dead children and adults to a European drug company called Kabi Vitrum, now part of the Pharmacia & Upjohn conglomerate. Kabi Vitrum flew organs to its parent company in Sweden who processed the growth hormone and then sold the product worldwide.
Third, the late-Victorian medical profession relied on the assumption that poorer people, whose families did not claim their bodies, did not care about their fate. In fact, the vulnerable often did not fully understand the outcome of their silence, nor could many afford to take an alternative decision. The Royal College of Pathologists still endorses this 'negative' principle of body ownership in its new guidelines. This means that unless the person prior to death or their family state 'positively' state that they do not want their tissue/organs to be utilised for research purposes, it will be assumed that no instruction means consent to such removal. Thus pathology has been allowed, under ill-defined laws, to hold itself distinct from broader cultural considerations. The 'retention' of tissue material without statutory public scrutiny ignores wider sensibilities. As the testimony of families involved in the Alder Hey controversy exemplifies, for many people whose loved ones die under tragic circumstances, burial rites ought not to be undervalued.
Fourth, the legal ownership of necropsies and their specimens has long been complex. In the case of coroners' necropsies that ownership passes to the Coroners' Office, which has the right to dispose of the cadaver in 'an acceptable or archived manner'. This discretion was first granted under the Anatomy Act (1832) and was reasserted in the Human Tissue Act (1961), under which coroners' necropsies can be retained 'for purposes other than identifying the cause of death'. It is estimated that around 90% of cadavers retained are coroners' necropsies. Neither the specimens retained, nor the archival material created has been regulated or registered. Nineteenth and twentieth century anatomical researchers have exploited these loop-holes. The scale of research material in anatomical museums today attests to their endeavours. It is still used to train medical students. Anatomical schools, notably Cambridge, set these standards and developed diverse research methods to hide their true activities. Their reductionist language and 'club cultures' still frame many bioethical debates today - the cadaver is a 'subject', 'tissue', 'project', 'sample', 'study' - to be used for 'medical advancement', 'for the benefit of humanity', 'to secure a better future' - all these historical paternalistic terms and phrases objectify and rationalise the treatment of necropsies.
Fifth, many anatomical practices have not been substantially revamped since the late-Victorian period. This is because when the 1832 Anatomy Act was introduced it laid down a broad framework for medical research procedures. However, it failed to put in place a mechanism for resolving ambiguities in interpretation and understanding of legislative guidelines, while it authorised the Anatomy Inspectorate to refuse to publicise the work of anatomical schools for fear of widespread public resentment. Consequently, medical technicians were given considerable discretionary powers and anatomy schools were not publicly accountable or audited properly. They were allowed to develop their internal research procedures without engaging in a consultation process. These procedures have survived to a greater or lesser extent today. Thus the Royal College of Pathologists in February 2001 conceded that anatomical legislation has been too discretionary and that there needs to be 'urgent coordination with the current Home Office review of death certification procedures'. And the Health Secretary, Alan Milburn, noted that 'problems have arisen because of outdated procedures rather than unprofessional practice' (Lancet, February 2001).
Having discussed these five broad historical parallels, we need to reconsider the way forward - can the lessons of the past help us to redress the legislative anomalies bequeathed by the formative late-Victorian era?
The way forward
Our discussion has highlighted some aspects of late-nineteenth century medical research that still resonate today. No-one denies the value that such medical advances have given society. We are all beneficiaries of medical pioneers in their respective research fields. However, the issue of consent and a culture of genuine public consultation also need to be taken into consideration in a broader debate addressing three fundamental questions about current medical research.
First, we need to question why anatomy schools can still procure bodies by the same methods that were enshrined under the 1832 Anatomy Act. Few realise that when an elderly person dies without family in the care of a nursing home, their carers automatically become their executor after death. Nursing home owners have the legal right to dispose of a cadaver, which they nursed, by passing it to an anatomical teaching school, thereby recovering costly burial fees. With many nursing homes built on the sites of former workhouses, this legal anomaly has a certain historical irony. Still a key method for the anatomical schools to obtain their material, this customary practice would offend many people's sensibilities if it were widely known. The law needs to be clarified to safe-guard the wishes of the poor, nameless and friendless too; and the question of how far current procurement practices contravene Human Rights legislation needs to be addressed.
Second, the question of who owns a cadaver needs to be revised legally. English property law states that once a person dies they can no longer decide the fate of their remains - this is a logical premise. However, where a person's wishes concerning the fate of a cadaver are not stated explicitly in their last will and testament, the law makes no allowances for the feelings of bereaved families. At a time of mourning when the sensibilities of grieving relatives are of prime importance, the medical community can legally ignore their wishes. The publication in August 2001 of the 'National Summit on the Retention of Organs and Tissues' guidelines under the auspices of the Royal College of Pathologists has begun to redress this question. It recommends that the Department of Health 'should address the extent to which individual Coroners can exercise discretion in respect of their responsibility to give information to bereaved relatives, to determine relatives' wishes concerning the disposal of retained material'. This is a welcome starting point but it still takes little account of the distress relatives often feel when part of their loved one's remains are retained following autopsy. The Royal College of Pathology supports a new Code of Practice to supplement existing law and the setting up of another regulatory body. However, this revises, rather than rewrites, out-dated legislation which takes its lead from flawed nineteenth century statutes and practices. And the principle of inspection by medical peers has not worked in the past, for all too often the general public feels that the medical profession closes ranks to protect its research priorities.
History teaches us to recognise continuities but it also points out that sometimes the only way to make progress is to renounce legal precedents. Medical research now operates against the background of a growing international market in organ and tissue sampling with strong commercial overtones. Aids research, vCJD studies, human-cloning investigations and the genome project all indicate how imperative it is to formulate new legal frameworks for the 21st century. Moreover, we have one major historical model that may provide answers to these dilemmas. Following the war crimes trials of Nazi doctors after the Second World War the international community issued the Nuremberg Code. Its ten-point agenda protected the rights of 'living' human beings undergoing medical experimentation. It set new medical research standards and began a process of establishing a legal framework, both nationally and internationally, of ground breaking bioethical precedents. These guidelines were then given full international recognition in the Helsinki Agreement of 1964 which bound medical clinicians and doctors to research benchmarks. This also set standards for the basic rights of patients involved in medical research. The Council for International Organisations of Medical Sciences later adopted this framework. In 1997 and again in 2000 the World Medical Association debated how to update research ethics. Medical research on 'living' patients has been subject to ongoing revision: a similar process needs to take place in the fields of pathology and anatomical research in Britain.
Third, we need to supplement any remaining loopholes in the law relating to the clinical uses of the body after death. Current lack of clarity has exposed the medical profession to a profusion of criticism. Many professionals (pathologists, coroners, police surgeons, forensic researchers, laboratory technicians and so on) genuinely believed they were working within a tight legal framework. In fact, as Alder Hey exposed, they were using considerable discretionary powers to procure and use research material. Though not illegal, these powers have contravened many customary expectations. Even in our secular world today death is a key rite of passage and when its formalities are undervalued the grieving process is accentuated for many people. In response, the Royal College of Pathologists has recently proposed extending the powers of Patients' Liaison Groups. If trust is to be rebuilt, this type of initiative needs to be expanded considerably, with greater patient representation on governing bodies, such as the General Medical Council (all but one doctor involved in the Alder Hey scandal were referred to and cleared by this governing body) and Royal College of Pathologists (oversees coroners' work). Moreover, we might also ask why anatomical teaching seminars in Britain are still closed to the general public when our European counterparts provide open access. Although not everyone wishes to attend a dissection, the principle matters. A culture of openness and consultation would build trust. In time, the general public would become less critical and fearful of the medical profession's work. This would enable pathologists to raise public awareness of the importance of their procedures. Exclusion only breeds distrust and misunderstandings. The way forward is through patient/doctor partnerships, shared decision-making and greater public accountability. This will benefit the medical profession because it will enhance the general public's willingness to co-operate and in the longer term that will help to advance medical knowledge.
We will never 'speak for the dead' but we can begin to protect the interests and sensibilities of their grieving families: the time has come to pursue the ethics of consensual medicine.
Gareth Jones, D., Speaking for the Dead: Cadavers in Biology and Medicine, (Abingdon, 2000) - the most recent textbook to explore anatomical uses of cadavers and the bioethical considerations of necropsy research.
Hurren, E.T., 'Labourers are Revolting: Penalising the Poor and a Political Reaction in the Brixworth Union, Northamptonshire, 1875-1885', Rural History, II, I, pp. 37-55 - a case-study analysis of how one Victorian community resisted ratepayers attempts to impoverish them in order to recover the costs of care in the community.
King, S., Poverty and Welfare in England, 1700-1850, (Manchester, 2000) - provides one of the most accessible, up-to-date and comprehensive overviews of the New Poor Law, and its regional variations in the Victorian period.
Porter, P., Quacks, Fakers and Charlatans in English Medicine, (Gloucestershire, illustrated edition, 2000) - a general reader by one of the most respected medical historians on the nature of medical training in the 19th century.
Richardson, R., Death, Dissection and the Destitute (New York, revised edition 2000) - set text on the implications and workings of the Anatomy Act (1832) - 2000 edition contains a foreword on the recent Alder Hey scandal.
Thomson, D., 'Welfare and the Historians', in Bonfield, L., Smith, R. M., and Wrightson, K. (eds.), The World We Have Gained, (Oxford, 1986), pp. 255-378 - still gives one of the best overviews of the social cost of removing the poor's right to community welfare in the late-Victorian period.
About the author
Elizabeth T. Hurren is currently a temporary lecturer in history at University College Northampton. Her main research interest is the late-Victorian Poor Law, the subject of her doctoral thesis. firstname.lastname@example.org