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RIJKSUNIVERSITEIT GRONINGEN

Medical futility in Dutch neonatology

Proefschrift

ter verkrijging van het doctoraat in deRechtsgeleerdheid

aan de Rijksuniversiteit Groningenop gezag van de

Rector Magnificus, dr. F. Zwarts,

in het openbaar te verdedigen opdonderdag 12 november 2009

om 13.15 uur

door

Sofia Morattigeboren op 23 augustus 1979

te Tirano (Itali)


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Promotor Prof. J. GriffithsCopromotor Dr. N.E.H.M. Zeegers

Beoordelingscommissie Prof. Dr. A. BosProf. H. BrringProf. M.J. Trappenburg


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MEDICAL FUTILITY IN DUTCH NEONATOLOGY

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . p. 1

The subject of this book . . . . . . . . . . . . . . . . . . . . . . . p. 1Criticism of the concept of medical futilityCriticism of Dutch end-of-life medical practice

Research questions . . . . . . . . . . . . . . . . . . . . . . . . . p. 3

Approach and methods . . . . . . . . . . . . . . . . . . . . . . . p. 3Combination of three methodsInterdisciplinary approach

1. THE CONCEPT OF MEDICAL FUTILITY . . . . . . . . . . . . . . . . p. 5

1.1.Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . p. 5

1.2 Perspectives on the idea of medical futility . . . . . . . . . . . . . . p. 7Futile treatments interfere with the natural process of dyingFutile treatments constitute a waste of resourcesAdministering a futile treatment is a violation of medical-professional standards

1.3 History and function of the notion of futility . . . . . . . . . . . . p. 12The origins of the notion of futility

From futility to physiological futilitySchneidermans contributionThe shift to a procedural approach

1.4 Professional guidelines for decision-making. . . . . . . . . . . . . . p. 17The model procedure designed by the American Medical Association (1999)The Texas statute (1999)Kleijers procedure (2005)

1.5 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . p. 22

2. THE REGULATION OF FUTILITY IN DUTCH NEONATOLOGY . . . . . . . . p. 23

2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . p. 23

2.2 The new medical power . . . . . . . . . . . . . . . . . . . . p. 24

2.3 The early history: towards regulation of abstention in neonatology (the 1980s) . p. 24

2.4 The formulation of rules by neonatologists: Doen of laten? (1986-1992) . . p. 28The working groupA picture of medical practiceMedical futility: kansloos and zinloosCriteria for decision-makingRole of the parents and possible disagreements

Death and documentationDeliberate ending of life and the grey area problem

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Natural versus non-natural deathConsultation with ethical and legal experts

Ratification of the reportConclusions. Regulation of abstention on grounds of futility in Doen of laten?

2.5 The Prinsand Kadijkrulings (1995) . . . . . . . . . . . . . . . . p. 42

2.6 Toetsing als Spiegel van de Medische Praktijk (1997) . . . . . . . . . p. 43A different approach to control of the grey areaSelf regulation by the medical profession of the decision-making process in case ofabstention

2.7 The Guideline on abstention in neonatology (2000) . . . . . . . . . . p. 45

2.8 Futility in the Groningen Protocol (2004) . . . . . . . . . . . . . . p. 46The Groningen ProtocolThe idea of medical futility in the Groningen Protocol

2.9 The establishment of a National Review Committee for cases of deliberateending of life of neonates (2006). . . . . . . . . . . . . . . . . . p. 49

2.10 Summary: regulation of abstention on grounds of futility in neonatologyin the Netherlands in 2009 . . . . . . . . . . . . . . . . . . . . p. 49

2.11 Data on abstention in neonatology (1995-2007) . . . . . . . . . . . . p. 51

2.11.1 National data . . . . . . . . . . . . . . . . . . . . . . . . p. 51Estimates of the frequency of end-of-life decisions in Dutch neonatologyin Doen of laten?

Table 2.1 End-of-life decisions in four Dutch NICUs in 1990Data from the national surveys

Table 2.2 Causes of death for babies under 1 years in 1995, 2001 and 2005(percentages)

Table 2.3 Characteristics of end of life decisions, 1995 and 2001 (percentages)The research by Verhagen et al. 2007 and the shift from the doctors intention tomedical indication in the definition of deliberate ending of life

Table 2.4 Cases involving the use of muscle relaxants in Verhagen et al. 2007

2.11.2 Comparative data. . . . . . . . . . . . . . . . . . . . . . . p. 57

Table 2.5 Proportions of doctors who report having made specificend of life decisions in various European countries (percentages)

Table 2.6 Neonatologists endorsement of arguments against abstentionin various European countries (percentages)

2.12 Conclusions: regulating medical futility . . . . . . . . . . . . . . . p. 60

3. OPERATIONALISATION OF FUTILITY IN TWO DUTCH NICUS: INTRODUCTION p. 61

3.1 Operationalisation of futility . . . . . . . . . . . . . . . . . . . p. 61

3.2 Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . p. 61

3.3 Patient population . . . . . . . . . . . . . . . . . . . . . . . p. 613.3.1 Brief description of the condition . . . . . . . . . . . . . . . . . p. 62

SOFIAMORATTI - Medical futility in Dutch neonatology

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3.3.2 Reasons for the choice of perinatal asphyxia . . . . . . . . . . . . . p. 65An unpredictable event

Difficult predictions for the babys future3.4 Research on patient files and interviews with neonatologists . . . . . . . p. 653.4.1 Study on patient files . . . . . . . . . . . . . . . . . . . . . . p. 663.4.2 Interviews with doctors . . . . . . . . . . . . . . . . . . . . . p. 673.5 Expected findings . . . . . . . . . . . . . . . . . . . . . . . p. 673.5.1 Definition and assessment of medical futility and poor prospects

for the future of the baby . . . . . . . . . . . . . . . . . . . . p. 683.5.2 Decision-making process leading to decisions to administer or not

administer life-prolonging treatment . . . . . . . . . . . . . . . . p. 68Role of the parentsRole of the parents draagkrachtImportance of potential ventilator-independence

3.5.3 Characteristics and duration of the dying process . . . . . . . . . . . p. 703.5.4 Boundaries between natural and non-natural death . . . . . . . . . . p. 703.5.5 Palliative drugs . . . . . . . . . . . . . . . . . . . . . . . . p. 713.6 Presentation of the results . . . . . . . . . . . . . . . . . . . . p. 72

4.OPERATIONALISATION OF FUTILITY IN TWO DUTCH NICUS: NICU A. . . . . p. 73

4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . p. 73

4.2 Results of the study on patient files . . . . . . . . . . . . . . . . . p. 734.2.1 Withdrawal of treatment. . . . . . . . . . . . . . . . . . . . . p. 744.2.2 Decisions to treat on grounds of clinical improvement . . . . . . . . . p. 884.2.3 Decisions not to resuscitate . . . . . . . . . . . . . . . . . . . . p. 924.2.4 Abstention not discussed. . . . . . . . . . . . . . . . . . . . . p. 1004.2.5 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . p. 104

Table 4.1 Overview of cases described4.3 Interviews with neonatologists . . . . . . . . . . . . . . . . . . p. 1064.3.1 Introduction and research sample . . . . . . . . . . . . . . . . . p. 106

4.3.2 Definition of futility . . . . . . . . . . . . . . . . . . . . . . p. 106Box 4.1. Definition of kasloos and zinkoos in NVK 1992 and CAL 1993

The ideas of quality of life and a life worth living

4.3.3 A recent case of conflict between the babys parents and the medical teamover administration of life-prolonging treatment . . . . . . . . . . . . p. 108Box 4.2. A recent case of conflict between the babys parents and the medical teamover administration of life-prolonging treatment in NICU A

4.3.4 Decisions to abstain on grounds of futility . . . . . . . . . . . . . . p. 114Box 4.3. Hypothetical case presented to doctors in the interview

Role of brain damageRelevance of the parentsdraagkracht

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4.3.5 Effects of potential ventilator-independence on decision-making. . . . . . p. 117

4.3.6 Doctors perception of the babys dying process . . . . . . . . . . . . p. 119

4.3.7 Administration of pain relief (in doses that might hasten death)in connection with abstention on grounds of futility . . . . . . . . . . p. 120

4.3.8 Deliberate ending of life after abstention on grounds of futilityand the grey area . . . . . . . . . . . . . . . . . . . . . . . p. 121Reasons against administration of muscle relaxantsReasons for administration of muscle relaxantsDoctors perception of the boundaries between natural deathand non-natural death

4.4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . p. 128

5. OPERATIONALISATION OF FUTILITY IN TWO DUTCH NICUS: NICU B . . . . p. 130

5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . p. 130

5.2 Results of the study on patient files . . . . . . . . . . . . . . . . . p. 130

5.2.1 Withdrawal of treatment. . . . . . . . . . . . . . . . . . . . . p. 130

5.2.2 Decisions to treat on grounds of clinical improvement . . . . . . . . . p. 137

5.2.3 Abstention not discussed. . . . . . . . . . . . . . . . . . . . . p. 145

5.2.4 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . p. 147Table 5.1 Overview of cases described

5.3 Interviews with neonatologists . . . . . . . . . . . . . . . . . . p. 1485.3.1 Introduction and research sample . . . . . . . . . . . . . . . . . p. 148

5.3.2 Definition of futility . . . . . . . . . . . . . . . . . . . . . . p. 148

5.3.3 Decisions to abstain on grounds of futility . . . . . . . . . . . . . . p. 149The idea of quality of life and a zinvol lifeRelevance of the parents draagkracht

5.3.4 Exceptions: decisions to administer futile treatment . . . . . . . . . . p. 152

5.3.5 Effects of potential ventilator-independence on decision-making. . . . . . p. 154

5.3.6 The dying process after abstention on grounds of futility . . . . . . . . p. 154

5.3.7 Deliberate ending of life after abstention on grounds of futility:the grey area and the boundaries between natural death and non-natural death. p. 156

5.3.8 Administration of pain relief (in doses that might hasten death)after abstention on grounds of futility . . . . . . . . . . . . . . . p. 158

5.4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . p. 159

6. EMPIRICAL INTEGRATION AND CONCLUSIONS . . . . . . . . . . . . . . p. 161

6.1 Research questions . . . . . . . . . . . . . . . . . . . . . . . p. 161

6.2 Operationalisation of futility . . . . . . . . . . . . . . . . . . . p. 161

6.2.1 The definition of futility and assessment of poor prospectsfor the babys future . . . . . . . . . . . . . . . . . . . . . . p. 162


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In patient filesIn interviews with doctors

Conclusions6.2.2 The role of the parents in the decision-making process . . . . . . . . . p. 163

In patient filesIn interviews with doctorsConclusions

6.2.3 The parents draagkrachtand its relevance in the decision-making process . . p. 165In patient filesIn interviews with doctorsConclusions

6.2.4 The role of potential ventilator-independence in the decision-making process . p. 166

In patient filesIn interviews with doctorsConclusions

6.2.5 Characteristics and duration of the dying process after abstention on groundsof futility . . . . . . . . . . . . . . . . . . . . . . . . . . p. 167In patient filesIn interviews with doctorsConclusions

6.2.6 Follow-up of live babies through patient files: the incidence of major mentaland motor retardation. . . . . . . . . . . . . . . . . . . . . . p. 168Conclusions

6.2.7 Administration of muscle relaxants and the boundary between naturaland non-natural death . . . . . . . . . . . . . . . . . . . . . p. 169In patient filesIn interviews with doctorsConclusions

6.2.8 Palliation . . . . . . . . . . . . . . . . . . . . . . . . . . p. 170In patient filesIn interviews with doctorsConclusions

6.3 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . p. 171

7. ETHICAL, LEGAL AND POLICY CONCLUSIONS . . . . . . . . . . . . . . . p. 174

7.1 Research questions . . . . . . . . . . . . . . . . . . . . . . . p. 174

7.2 Medical futility as a problem of regulation. . . . . . . . . . . . . . p. 174

7.2.1 A procedural solution . . . . . . . . . . . . . . . . . . . . . . p. 174

7.2.2 The procedural solution in practice: Doen of laten? . . . . . . . . . . . p. 175

7.3 The justifiability of regulating medical futility and deliberate ending

of life differently . . . . . . . . . . . . . . . . . . . . . . . p. 1767.4 Medical futility and eugenics. . . . . . . . . . . . . . . . . . . p. 177

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7.4.1 What is a handicap? Group 1 . . . . . . . . . . . . . . . . . . . p. 177Survival

A merely vegetative life7.4.2 The five criteria in Doen of laten?. Groups 2 and 3 . . . . . . . . . . . p. 178

What is suffering?A medicalized lifeI communicate, therefore I existTransition from childhood to adulthood

7.5 Concluding remarks . . . . . . . . . . . . . . . . . . . . . . p. 182

APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p. 183

List of questions used in the interviews . . . . . . . . . . . . . . . . . p. 183

Summary of findings from empirical research . . . . . . . . . . . . . . . p. 185Table Findings from patient filesTable Findings from interviews

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . p. 188

SAMENVATTING IN HET NEDERLANDS . . . . . . . . . . . . . . . . . . . . p. 196

CURRICULUM VITAE . . . . . . . . . . . . . . . . . . . . . . . . . p. 201

ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . p. 202


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1 Griffiths, Bood and Weyers mention the Latin proverb primum non nocere(first, do not harm), which,

together with in dubio abstine(when in doubt, abstain) is one of the ethical cornerstones of medicine.Griffiths, Bood and Weyers 1988: 120.

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Introduction

INTRODUCTION

The subject of this book

T his book is about the concept of medical futility and the regulation andoperationalisation of medical futility in Dutch Neonatal Intensive CareUnits (NICUs). A NICU is a high-technology medical setting, where most ofthe life-prolonging treatment available for desperately sick newborns isadministered. Medical futility is a legal and ethical ground for withholding orwithdrawing life-prolonging treatment from a patient whose condition is toopoor to justify (further) medical intervention. It is supposed to be a hard andmedical criterion, based on the doctors technical expertise. In connection withits (real or supposed) objectivity, medical futility can be a ground for unilateralnon-treatment decisions. This means that if a treatment is medically futile, thedoctor or medical team should withhold or withdraw it even over the objectionsof a competent patient (or, in the case of a non-competent patient such as ababy, its representative).

The interpretation of the concept of futility necessarily allows a margin offlexibility. In the first place, the principle of proportionality must be taken intoaccount. One of the basic principles of medicine is non-maleficience.1 Potentiallylife-prolonging treatment that will not cause harm to the patient is hardlysubjected to futility considerations. For example, some terminal patients chooseto take part in clinical trials of treatment that is not yet part of routine medicinebecause there is not sufficient evidence of its benefit. Most of the experimentaltreatment administered in clinical trials does not cause adverse effects (or if it

does, these are only minor). Medical futility is more relevant where aresignificant chances that the treatment will cause a harm that is not proportionalto the benefit. For example, this is the case of major surgery that is unlikelysignificantly to improve an incurable condition. A second qualification of theprinciple that futile treatment should not be given is that, whenever possible,


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the moment at which abstention on grounds of medical futility is carried outshould be chosen according to the preference of the patient (or of his loved ones).

Even when so interpreted, the concept of medical futility (and itsimplementation in neonatology in particular) has been the object ofconsiderable controversy, as has Dutch end-of-life medical practice in general.I will elaborate on both points of criticism below.

Criticism of the concept of medical futility

The role of doctors. A fundamental objection to accepting the concept of medical

futility as legal basis for withholding or withdrawing treatment is that doing sogives considerable power over life and death to doctors, excluding other actorsfrom the decision-making process over administration of life-prolongingtreatment. In particular, in the case of newborns, critics hold that there is adanger that the parents could be marginalized in the decision-making process.

The idea of eugenics. Much of the criticism of the idea of futility is connectedwith the idea of eugenics. This term, originally referring to the project oftransforming the human race through controlled and planned breeding in order

to pass desirable features along to subsequent generations, came after WorldWar II to refer to the systematic elimination of individuals who do not meetcriteria set by those in power. The danger, critics of medical futility maintain,is that the concept of futility will serve as a legal and ethical basis for justifyingdiscrimination against handicapped babies, who will be denied life-prolongingtreatment that is routinely administered to babies who do not have handicaps.

Criticism of Dutch end-of-life medical practice

There has been much international criticism of the way end-of-life medicaldecisions in neonatology are regulated in the Netherlands. What makes theNetherlands so controversial internationally is the fact that some (although verylimited) room is allowed for the use of lethal drugs to deliberately end the lifeof a baby who is suffering unbearably without prospect of improvement.

While it is deliberate ending of life that is internationally controversial,empirical research shows that withholding and withdrawal of life-prolonging

treatment on grounds of medical futility takes place much more frequentlyand is not at all limited to the Netherlands. Furthermore, many of the


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considerations involved in the two practices are much the same and Dutch lawand practice require that a decision based on the futility of further treatment betaken before deliberate ending of life can be considered. Withholding andwithdrawal of treatment on grounds of futility seems thus to deserve ethical,legal and empirical attention at least as much as deliberate ending of life.

Research questions

In general, I investigate the use of medical futility in connection with abstention

decisions in Dutch neonatology and the characteristics of the decision-makingprocess. To what extent is such practice regulated, and is medical practiceconsistent with existing regulation? Who are the actors in the decision-makingprocess over withholding or withdrawal of medical treatment on grounds offutility? In particular, what is the role of parents and what is the role of doctors?These questions will be answered in Chapter 6, which integrates the empiricalfindings of my research.

In particular, I seek to respond to the criticism of the concept of medical futility

and of Dutch end-of-life medical practice in neonatology, by drawing ethical,legal and policy conclusions on the following points in Chapter 7:

1. Medical futility as a problem of regulation. Is the Dutch system of controlover withholding and withdrawal on grounds of medical futility, as itfunctions in practice, adequate?

2. The boundaries between medical futility and deliberate ending of life. Is it goodpolicy to subject the two to fundamentally different control regimes as ispresently in theory the case in the Netherlands?

3. Medical futility and eugenics. Can end-of-life medical decisions be justifiedand is medical futility an adequate criterion for making end-of-life decisions?

Approach and methods

Combination of three methods

In this book, medical futility in Dutch neonatology is investigated with threedifferent methods:

Introduction

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(1) A review of the existing theoretical and empirical literature on medicalfutility, including the Dutch regulation of withholding and withdrawal oftreatment in the neonatal care setting and quantitative and qualitative dataabout end-of-life medical practice in neonatology.

(2) A study of patient files in two Dutch NICUs.

(3) Face-to-face interviews with doctors in two Dutch NICUs.

Interdisciplinary approach

Medical research on the decision-making process at the end of life usually results

in concise, condensed reports of medical (mostly quantitative) data. Myempirical research largely takes a more sociological and qualitative approach. Ireport extensively doctors answers to my questions and their descriptions ofthe decision-making process, quoting their exact words when these shed lighton a particularly interesting issue. At the same time, the medical context is notdismissed as secondary. Knowledge of the shop floor where decisions are madeenriches sociological work and requires some familiarity with medical-technicalaspects of neonatal care. Finally, those parts of the book that are not dedicated

to my own investigation of medical practice present the legal developments thatlead to regulation of abstention on grounds of medical futility in theNetherlands and discuss medical futility from a legal and ethical standpoint.

Apart from my own findings, I interpret the results of Dutch and internationalconceptual and empirical literature, which adds to the persuasive power of myconclusions. In the concluding chapters, I make use of all of these various sortsof data together to try to answer the questions with which I began.


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*A condensed version of this Chapter appeared in the Journal of Medical Ethics (Moratti 2009).1 Murphy 1988 and Youngner 1988.2 These regional differences are illustrated in Griffiths, Weyers and Adams 2008.

3 Helft, Siegler and Lantos 2000.4 Schmidt 2000 and Lawson 2004.

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Ch 1 - The concept of medical futility

1. THE CONCEPT OF MEDICAL FUTILITY*

1.1 Introduction

Over the last fifty years technical advances have taken place in medicine that havegreatly increased the possibilities of life-prolonging intervention. The increasedpossibilities of acting have brought with them new ethical questions. Noteverything that is technically possible is appropriate in a specific case: noteverything that can be done shouldbe done.

In the 1980s, a new term was coined to indicate inappropriate interventions:medically futile treatment.1A debate followed, with contributions from boththe United States and several western European countries. A similar debate latertook place in Mediterranean countries, although with a different terminologyand a less direct connection with medical practice.2 Despite all the attention,however, no consensus has yet been reached concerning the content andfunction of the term nor over methods of assessing futility in individual cases.3

The purpose of this chapter is to analyse the concept of futility, that is, to showwhat its function is in the context of a system of ethical and legal rules governingthe practice of medicine, and to explore how the concept can be operationalisedfor purposes of clinical decision-making.

Futility can of course refer to behaviour that has nothing to do with doctorsor medicine. Some authors have found it useful to discuss the etymology of theword futile, that seems to trace back to Greek mythology.4 In this chapter Ifocus on the medical setting, where futility can be identified as a criterion forclinical decision-making on withholding or withdrawing interventions inindividual cases. While such a concept of futility could be applied to all sorts ofmedical interventions that might be performed without being medicallyindicated things such as certain medical screenings and cosmetic surgery inpractice the literature on futility deals only with life-saving and life-sustaining


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5 This narrow meaning is reflected in professional guidelines and consensus statements (see e.g. Councilof Ethical and Judicial Affairs of the American Medical Association 1999 and Truog et al 2001).

6 Dunphy 2000.7 Truog 2000.8 Faber-Langendoen 1991, Jecker and Pearlman 1992.

9Jennett 2002.10 Nyman and Sprung 2000.

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medical interventions.5 It is with this more limited application of the concept offutility that this book will deal.

Even when thus limited to life-prolonging interventions, the concept offutility can be relevant for a wide variety of medical conditions and interventions.For example, in the 1970s and 1980s cardio-pulmonary resucitation (CPR)became an almost routine intervention, performed even on patients with advancedmetastatic cancer, stroke, or sepsis, and continued after more than 30 minutes ofresuscitating efforts despite the brain damage that would have occurred in themeantime.6 Other examples of medical interventions that are technically possiblebut not necessarily desirable include artificial ventilation in the case of comatoseand metastatic cancer patients,7 surgery when the risks of operative morbidity arevery high, new transplants after earlier failures,8 and artificial nutrition andhydration in permanent vegetative state patients.9 The list could also includevarious other treatments, ranging from blood transfusions to antibiotics, fromdialysis to fluid therapy for the severely burned.10

The first part of this Chaptershows that the notion of futility can be approachedfrom different perspectives. One approach is based on the idea of nature.Proponents of this approach hold that a futile medical treatment is aninappropriate human intervention in the natural order of things (or, in otherwords, constitutes an interference with a transcendent plan that humans are inprinciple not supposed to try to alter). A second approach is essentially economic.

An intervention is futile if it constitutes a waste of scarce resources that couldbetter be spent on something else. A third approach is based on the limits of theprofessional autonomy of doctors of their authority to practice medicine. Aftera short introduction to the three approaches, I will pursue this last approach,because it allows me to focus on what, as I will show, is the core of the problem

of operationalising the notion of futility: defining the role and powers of doctorsin the decision-making process concerning whether or not to withhold orwithdraw a particular medical intervention.


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11 For a fuller account of the natural law approach of the Roman Catholic Church, see Moratti 2008a.

12 Finnis 1980, Callahan 1991, Cattorini 1997.13 Connelly 2003: 46.

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The second part of this Chapterfocuses on the history of the operationalisationof the notion of medical futility. The concept of medical futility was firstintroduced as an ethical (and, possibly, legal) justification for unilateralabstentiondecisions made by doctors, either when the patient (or his representative) cannotbe consulted, or in case of conflict between doctors and patients (or theirrepresentatives) over administration of (further) life-prolonging treatment.Conflict might arise, for example, in the case of a terminal patient who insists on(continuation of) chemotherapy, despite the fact that his doctor deems thetreatment pointless. I will show that the many and very different proposals foroperationalisation of medical futility that have been put forward all seek to

maintain this function of the concept namely, justifying unilateral abstentiondecisions made by doctors.

1.2 Perspectives on the idea of medical futility

The notion of medical futility can, as I noted above, be approached from threedifferent perspectives. I give here a brief account of each of them.

Futile treatments interfere with the natural process of dying

Proponents of this approach believe that there is a natural life span that humanbeings are meant to live. Artificial shortening or prolongation of our natural lifespan is morally wrong. Originally developed by the Roman Catholic Church,11

this approach has been adopted by various philosophers.12 It has a certain intuitiveappeal so long as it is applied to the very elderly. The wise man who has childrenand grandchildren, and has had all of the most important experiences that lifehas to offer, accepts death as the natural, inevitable conclusion of life. Some havegone so far as to treat this philosophical attitude toward the end of ones life as amoral imperative and have argued that there is an obligation to accept death.13

However, lethal illnesses also affect the young. A baby born with a conditionincompatible with long-term survival can be regarded as terminally ill from themoment of its birth, although life has hardly offered it anything yet. Nature


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14 Singer 1993.15 Capron 1994, Kish Wallace Ewer, Price and Feeley 2002, Luce and Rubenfeld 2002.16 See Basta and Tauth 1996.17 Den Exter and Hermans 1999.18 Medical futility has special salience when medical insurance, either public or private, is used to pay

for the treatment. Burt 2002: 252.19 Physician discretion in [] triage decision-making for the allocation of scarce resources is an accepted

aspect of medical carenotwithstanding its tragic implication that some must die so that others can live. Burt2002: 251.

20 The word triagecomes from the French trier- which means to sort out - and was first introduced bymilitary surgeons in World War I. On the history of the concept oftriagesee Blagg 2004.

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destines some to die much younger than others, and it does so regardless of theamount of fulfilling experiences that a person has had. Nature does not seemalways to arrange events in a fashion that conforms to our intuitive sense offairness.14

We cannot derive our ethical criteria for making life-and-death decisions frombiological processes that in themselves do not have any moral connotation. For thisreason, the approach to medical futility based on the idea of nature must berejected.

Futile treatments constitute a waste of resources

According to the proponents of the economic approach to medical futility, thefutility debate is ultimately a controversy about the allocation of scarce health-care resources.15 Futility is a criterion of distributive justice for the rationing ofhealth care, where the organization of the health-care market imposes needs forcost-containment.16

In democratic countries, the health-care market is divided into two segments.Some medical care is directly sold to individuals who pay for it out-of-pocket, the

allocation problem being solved by the law of supply and demand, while the restis provided by public or private insurers that spread the costs of medicalinterventions.17 Proponents of the economic approach to medical futility believethat considerations of futility are primarily relevant for the latter segment,18 wherescarcity of resources and the absence of a pricing mechanism makes it necessaryto elaborate criteria for triage(that is, limiting expensive interventions to situationswhere they are most cost-effective.)19 The term triage originated in militarymedicine,20 and refers there to the classification of victims of war casualties into


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21 Contra Beauchamp and Childress 2001.

9


different categories, so that the scarce care available in the battlefield can beconcentrated on those patients who would otherwise die but are likely to surviveif treated. The use of the concept was extended to civilian medical practice in the1960s in connection with the distribution of newly introduced and expensive life-saving interventions such as dialysis and organ transplantation.

Adopting criteria for access to health care based on considerations ofdistributive justice can be a responsible choice in contexts of severe shortage ofresources connected with war or other emergencies, or in situations of widespreadand severe poverty. However, such criteria can lead to unjustified inequalities ifapplied in situations of peace, democracy, and economic prosperity, when it ispossible to adopt social policies that preventscarcity of health care. When societyfails to meet this responsibility, doctors find themselves confronted with dilemmasof distributive justice in clinical decision-making about individual patients. Forexample, if there is not enough personnel in an Intensive Care Unit to take careof all patients in need, doctors may be forced to deny admittance to some,knowing that doing so will almost certainly cause serious harm to the people whohave been left out.

In my view, it is not appropriate that doctors in a clinical setting makedecisions concerning the allocation of health care resources. The medicalprofession is thereby subjected to divergent ethical imperatives. The primaryprofessional responsibility of doctors is to promote the well-being of individualpatients by giving medically indicted treatment. The fact that a technology isextremely expensive and hardly available does not make it any less medicallyindicated for a patient who has a good chance to recover if treated. Medicalpractice should be so structured that doctors are not forced to discriminatebetween patients. It is society at large that must provide the medical professionwith a professional context within which distributional decisions have alreadybeen made. Promoting equity in the health care sector is a fundamental politicalvirtue for asociety, but not one of the ethical imperatives ofclinical medicine.21

Medical ethics (among them, the idea of futility) pertains properly to theappropriateness of treatment of the individualpatient, judged in light of the bestinterests of the patient, his well-being and expectations for the future.Interventions should not be labelled futile to justify denying them to certain


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22 Schneiderman, Faber-Langendoen and Jecker 1994.23 See Griffiths et al. 1998: 91.24 See the observation made by Cohen 2003: [M]ost providers do not obtain consent to initiate

mechanical ventilation for the patient with acute respiratory failure, although we do so for the patient with

end-stage lung disease. We do not obtain consent to administer albumin or crystalloid for resuscitation ofthe hypovolemic patient, but we now obtain consent to transfuse blood.

10


human beings when resources are scarce, nor should cheap and abundant22

treatments (for example, artificial nutrition and hydration) be initiated (ormaintained) if doing so is not in the interest of the individual patient.

Administering a futile treatment is a violation of medical-professional standards

The third approach to medical futility is based on an analysis of the scope of theprofessional autonomy of doctors. I shall argue that this approach, unlike theforegoing two, is analytically sound.

This approach to futility is grounded in the relationship between the law and

the practice of medicine. Both the civil and the criminal law prohibit intentionalor negligent violations of physical integrity. However, a large part of theprofessional behaviour of doctors consists precisely of invading the body of thepatient. Hence the need of a legal instrument to exclude from liability doctorswho act in their professional capacity. This instrument is the medical exception,a non-statutory (or implicit) exclusion of medical behaviour from the coverageof those provisions of the criminal law that protect the integrity of the body.23 Itdiffers from a justification in that the medical exception does not itself prescribe

how the behaviour that otherwise would violate the civil and criminal law is to becarried out. In effect, this is left largely to self-regulation by the medical profession.Thus, the medical profession enjoys a certain standard-setting autonomy.

The authority to practice medicine is not without limits, and the medicalexception applies only if the behaviour of the doctor remains within them. In thefirst place, the behaviour in question must not be specifically prohibited by thelaw. A number of medical procedures are clinically possible, but illegal in somecountries. Prohibitions of medically indicated abortion (for example, to save the

mothers life), which exist in several countries, are an example.Secondly, the patient, if competent, must have consented to the medical

procedure and the consent must be voluntary and well informed. If the patient is


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25 See Griffiths et al. 1998: 118 and Cohen 2003.

11


not competent, most legal systems allow a surrogate to act as a substitute consent-giver.

The consent requirement has exceptions. Obtaining consent is not alwayspossible in emergencies, where the patient is unconscious and treatment decisionshave to be made very quickly. The unconscious patient taken to the hospital wardafter a traffic accident receives life-saving treatment if immediately necessary,available and appropriate, regardless of the fact that he is unable to consent. Albeitnon-consensual, in those cases the medical intervention does not violate the civilor criminal law because it is performed in a situation of necessity, in order toprevent an immediate danger to life.24 This situation is becoming more and morefrequent, especially in the intensive care setting, where doctors need to makedecisions quickly and to give treatment immediately in order to win time to makea diagnosis that will serve as a basis for further treatment decisions.25

Finally, the intervention of the doctor must be performed in accordance withprofessional standards. The expression professional standards encompasses twosets of rules. First, doctors must act with the technical-medical skills that formthe core of the profession, and exhibit due care in performing their professional

duties. The doctor who violates this standard does not act within his authority topractice medicine, making himself liable to civil or criminal sanctions. The doctorwho incompetently gives a wrong diagnosis or negligently forgets a surgical toolin the patients womb is an example of violation of such professional standard.Second, professional standards include criteria of appropriateness in giving medicalcare, laid down in official clinical guidelines. Such guidelines are based on acombination of scientific evidence (such as statistical studies of the effects of agiven treatment) and medical-ethical considerations concerning the patientswelfare. The idea that medically futile treatment should not be given is anexample of such a professional standard. Performing a futile treatment does notamount to incompetence or negligence in the strictest sense, but nevertheless doesconstitute a violation of a medical professional standard, and the medicalexception therefore does not cover it.

To summarize the conclusion of the above discussion: futility can beconsidered a negative professional standard limiting the authority to practicemedicine. It is not within the authority of a doctor to invade the patients physical


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26 Murphy 1988.27 Tomlinson and Brody 1990, Schneiderman and Jecker 1995, Weijer and Elliott 1995.28 Murphy 1988.29 Because demented patients in long-term care institution are no longer compos mentis, patient

autonomy in fact refers here to the will of the family or representatives.

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integrity by performing a futile intervention. Nor can the patient (or hisrepresentatives, or other actors in the decision-making process over futility inindividual cases) oblige a doctor to act beyond the scope of his professionalauthority by doing so.

1.3 History and function of the notion of futility

The origins of the notion of futility

The notion of medical futility first appeared in the 1980s. Its early proponentswere doctors from the United States.26 Its function was that of putting a limit tothe increasing requests for treatment that patients felt entitled to make on doctors.

After the 1960s and the 1970s, patient autonomy was interpreted in a more andmore radical way. Patients considered that they not only had the right to refuseanunwanted medical intervention but also to insiston one they thought they wanted.

With increasing frequency, patients (or their family or representatives) woulddemandspecific treatments that doctors did not consider appropriate.

Many doctors objected to this very ample interpretation of the principle ofpatient autonomy. Legally and ethically, the position of the patient who refuses amedical intervention is radically different from that of the patient who demandsone. It is not difficult to find a foundation for the right to refuse medicaltreatment, namely, as we have seen, in the criminal law provisions prohibitinginvasions of bodily integrity. It is quite a different matter to find legal and ethicalgrounds for the power to obligea doctor to perform an intervention that the doctorconsiders inappropriate and contrary to his professional standards.27

The core issue in the futility debate is the role (and, in connection with that,the authority) of the doctor in the decision-making process over abstention.28 In1988, a provocative contribution opened the futility debate, proposing givingdoctors the power to make unilateral do not resuscitate decisions for severelydemented and chronically ill patients in long-term care institutions.29 The


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30 Murphy 1988.31 Lantos et al. 1989, Weijer and Elliott 1995.32Youngner 1988.

33 Frick, Uehlinger and Zuercher Zenklusen 2003.34 See previous note.

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argument used was that, in some cases, clinical indications should be givenpriority over patient autonomy. The power of doctors to decide unilaterally wassupposed to be based on their medical-technical expertise.30

Ever since its first appearance, the notion of futility has been the object ofstrong criticism. Some saw in it an attempt to reintroduce medical paternalism(that is, the assumption that the doctor always knows best). They argued that thepatient and his family (or representative) should always be involved in thedecision-making process and informed of all decisions made by the doctors.

Arriving at the conclusion that (further) treatment is futile is not a hard andtechnical-medical judgment, critics argued. Rather, it is a delicate matter basedat least in part on highly subjective, soft and normative evaluations of qualityof life.31 Doctors should not be given the power to impose upon their patientstheir own personal values under the guise of medical expertise.32

From futility to physiological futility

In reaction to such criticism, proponents narrowed the scope of the notion offutility. They argued that the primacy of technical-medical expertise (and, thus,

the unilateral authority of the doctor) applies only to cases of physiologicalfutility: the situation in which the treatment concerned will not achieve thebiological result intended and assessing its futility is therefore an objective andtechnical operation that does not involve any normative quality-of-life

judgment. But attempts to determine more specifically the content of the notionof physiological futility did not lead to more convincing results than earlierattempts to define futility in general.

Some contributions suggested that prognostic scoring systems appropriately

operationalize physiological futility.33

Prognostic scoring systems or mortalityprobability models34 consist of statistical information concerning the risk ofhospital (or ICU) mortality for critically ill hospitalised patients, based on clinicalvariables such as the patients age and clinical condition. The most often used


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35 Several contributions to the futility debate have a more technical nature and deal only with a singletypology of patients or a single typology of treatment. Kleijer 2005 mentions among the organ-specificscoring systems the LOD-system (Logistic Organ Disfunction System), the GCS (Glasgow Coma Scale)and the SOFA (Sequential Organ Failure Analysis).

36We can never predict whether a patient will defy statistical odds and improve when by all objective andsubjective criteria such improvement seems beyond the realm of possibility (Ewer 2001). A similar objectionto the use of prognostic scoring systems is made by Jecker and Pearlman 1992 and Ridley 2002.

37 Kleijer 2005.

38 Ewer 2001.39 Ewer 2001.

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prognostic systems are the SAPS (Simplified Acute Physiology Score), theAPACHE (Acute Physiology and Chronic Health Evaluation) and the MPM(Mortality Prediction Model).35 Scoring systems are mostly used in the IC context,and can be classified into general, disease-oriented (e.g. severe burns), andpatient-group oriented (e.g. children).

It is universally acknowledged in the medical world that scoring systems aregood instruments to substantiate clinical judgements of futility through empiricaldata. However, they cannot explain individual deviations from the statisticallymost likely outcome.36 Knowledge of the fact that the patient belongs to a groupwith 80% mortality, rather than a group with 5% mortality, is certainly relevantfor decision-making,37 but does not lead to a definite prognosis with regard tothe individual patient. Nor does 80% mortality in itself tell us whether a treatmentis futile or not. In order to make a decision about treatment (or abstention) inthe individual case, data provided by scoring systems must be integrated withevaluations of a less hard and technical nature and with considerations otherthan the chance of success (such as the burden to the patient of the treatment).

In short, the notion of physiological futility has been subjected to the same

criticism as that of futility in general. Unless the life-prolonging treatment isimpossible (for example, in the case of surgical treatment for certain types ofpervasive brain cancer), the choice whether or not to intervene is always made (toa greater or lesser extent) with normative considerations of proportionality andquality of life in mind.38 The notion of futility can best be represented as acontinuum,39 ranging from situations in which the technical difficulties connectedwith intervening weigh so heavily that quality of life considerations are hardlyrelevant (for example, continuing blood transfusion when pressure cannot bestabilized), to situations in which a treatment, considered apart from its


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40 Cohen 2003 and Ardagh 2005.41 Together with Jecker, Schneiderman further specified his position in a book published in 1995. See

Schneiderman and Jecker 1995.

15


consequences, would work but would lead to a poor quality of life. Decisions insome cases are certainly much more value-laden than in others. However, thedifference between the two is a matter of degree and the grey area in between thetwo is far larger than the extremes.

By the early 1990s, it was generally understood that no purely technicalassessment of futility is possible. There was increasing skepticism about the ideaof basing doctors power to make unilateral abstention decisions on their clinical-technical expertise.40 Proponents tried to maintain the original function of thenotion of futility by seeking a definition of futile treatment that could be thesubject of ample professional and social consensus. It was assumed that thepresence of such consensus would provide a justification for unilateral abstentiondecisions. It was in this context that, in 1990, Schneiderman made an importantcontribution.41

Schneidermans contribution

Schneidermans contribution is often believed to have represented a turning pointin the futility debate. His work aimed at finding a definition of futility, which

could serve as a basis for a doctors authority to make unilateral abstentiondecisions that the majority of people in society (including the medical world)would find acceptable. The debate in the 1990s was a series of reactions toSchneiderman. Nevertheless, one can wonder in retrospect whether hiscontribution was innovative enough to justify the amount of attention that itattracted.

Schneiderman argued that the futility of a treatment can be measuredaccording to a quantitative and a qualitative parameter. An intervention can be

defined as quantitatively futile if doctors conclude through personal experience,experiences shared with colleagues or consideration of reported empirical data,that in the last 100 cases a certain intervention was useless.

The concept of quantitative futility was not really a significant innovation,as it is merely a way of interpreting statistical data collected in prognostic scoringsystems and in the medical literature. More precisely, it is a quantification of the


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42Jecker and Pearlman 1992.43 Schneiderman, Jecker and Jansen 1990.

16


minimum percentage of intervention failures, below which the predictive powerof statistical data can be considered strong enough to justify the decision toabstain. Furthermore, a normative element was smuggled into the idea ofquantitative futility through the back door. By useless intervention,Schneiderman et al. mean treatment that fails to benefit the person, even if itcontributes to the functioning of the organism. Benefit is, of course, what thewhole debate is about.

By qualitatively futile Schneiderman refers to any treatment that merelypreserves permanent unconsciousness or that fails to end total dependence onintensive medical care. In effect, a minimum standard of quality of life is fixed,below which life-prolonging treatment is futile.

Schneidermans definition of futility was criticized for being too restrictive.Some pointed out that the 1% cut-off for quantitative futility is so low that ismakes the notion of futility essentially useless. Others maintained that, despitewhat Schneiderman claims, the notion of quantitative futility does involve value

judgements.42 Still others attacked the idea of qualitative futility because it doesnot give guidance for the truly ethically challenging situations. It refers only to

constant monitoring, ventilatory support, intensive care nursing, conditionsassociated with overwhelming suffering for a predictably brief time, to the extentthat [the patient] cannot achieve any other life goals and excludes patients whoseconditions require frequent hospitalisation, patients in nursing homes orpatients who have severe handicaps.43

It seems reasonable to assume that the reason Schneiderman restricted thedefinition of futility so narrowly is because there is no sufficient professional andsocial consensus on a broader definition. The idea behind Schneidermans

contribution was certainly original and brave. He tried to find common groundon what was in fact a very controversial issue. However, the criticism that his workhas received, and Schneidermans own cautiousness when it came to specifying thecontent of the notion of futility, have shown that even such a modest attempt wasperhaps too ambitious.


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44 Council of Ethical and Judicial Affairs of the American Medical Association 1999.45 Compare Moldow et al. 2004, describing the Minnesota Guidelines, and Johnson and Potter 1999, who

mention several projects for developing futility guidelines in the United States (California, Minnesota, Texas,North Carolina, Colorado, Ohio and Wisconsin).

17


The shift to a procedural approach

Since the mid-1990s, attempts to define a medically futile treatment weregradually abandoned. Once it became clear that no consensus could be reachedon a definition of futile treatment broader than Schneidermans, a major changetook place in the approach to the operationalisation of the notion of medicalfutility. Attempts were made to design procedures regulating the powers of thevarious actors involved in the decision-making process and aimed at minimizing(and, where possible, preventing) conflicts.44 The original function of the notionof futility was maintained by giving the last word to doctors in case of irresolvable

disagreements with the patient (or his representative). Some important examplesof futility guidelines are given in the next paragraph.

1.4 Professional guidelines for decision-making

The United States seems to have the most experience with institutional futilityguidelines.45 This is probably due to the influence of the 1999 report by theCouncil for Ethical and Judicial Affairs of the American Medical Association. The

procedure laid down in this report had a major impact on the debate and wasused as a basis for the elaboration of futility guidelines at the level of individualinstitutions in the United States and in other countries.

The model procedure designed by the American Medical Association (1999)

The report of the Council for Ethical and Judicial Affairs contains a detailed modelprocedure for decision-making on abstention from life-prolonging treatment ongrounds of futility, and ends with a recommendation addressed to American

health care institutions, suggesting adoption of a similar procedure.In the view of the Council, doctor, patient (if competent) and proxy should

discuss treatment choices in advance, that is, beforecritical illness occurs. Thisstage is defined by the Council as prior assessment of values. If disagreementsemerge already at this stage, the Council suggests transferring the patient to the


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46 The Council refers here to the well-known case In the matter of Baby K, 16 F3d 590 (4th Cir 1994),involving an anencephalic baby. The mother of the baby disagreed with the doctors, who favored withdrawalof ventilation. The doctors suggested transferring the baby to a different NICU willing to comply with thewishes of the mother. No such NICU could be found and the baby was eventually placed in a nursing home.The mother agreed to the transferal on one condition: the baby was to be readmitted to the hospital whenevernecessary to prolong her life. After several admissions during the first months of life, including a tracheostomy,

the hospital sought a judicial decision. The doctors were ordered to continue treatment. The baby died ofcardiac arrest at two and a half years of age, most of which it spent in the NICU.

18


care of a different doctor within the same institution, or to a different institution.This first step is thus intended to preventpossible conflicts later on.

When critical illness actually occurs, the doctor and the patient (or proxy)must choose together a course of treatment. The Council stresses that treatmentdecisions should be made with the support of prognostic scoring systems. Shouldthere be disagreements, the Council suggests seeking the assistance of a consultant.Should the disagreements persist, the Council suggests involving an institutionalEthics Committee. If, notwithstanding the intervention of the Committee, thedisagreements cannot be overcome, the patient should be given the opportunityto be transferred to the care of a different doctor within the same institution, orto a different institution willing to comply with the patients (or the proxys) wishesconcerning (further) treatment.If no such doctor or institution can be found, inthe Councils view it should be possible for a doctor to withdraw treatment evenif the patient (or representative) does not accept this decision. However, theCouncil admits that in the light of judicial decisions in such cases, the legalramifications of this course of action are uncertain. 46 The patient or his familymight decide to go to court and seek a court order obliging doctors to start (orcontinue) intervention.

The procedure designed by the Council is represented on the diagram below.


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47 See note 45.48 This account of the content of the Texas statute is based on Fine and Mayo 2003.

19


The Texas statute (1999)

The American Medical Association model procedure had a major impact on thefutility debate. Several decision-making procedures were elaborated along thelines of the AMA model and adopted at the institutional level or at a broaderlevel.47 In 1999, Texas passed a law establishing a procedure for solvingdisagreements over medical futility between the medical team and the patient(or family). The procedure is designed for a situation where the medical teamthinks that further treatment is futile while the patient (or his family) does not,and is based on the AMA model.48

The Texas law does not provide a definition of medical futility. The decisionon futility is made on a case-by-case basis, when disagreement arises between adoctor and a patient over treatment the doctor considers futile. The case isconsidered by an ethics committee, consisting of various health care professionals

Prior deliberation of values

Joint decision-makinginvolving both

doctors and patient (or proxy)

Involvement of a consultant

Ethical Committee deliberation

Attempt to find an institutionwilling to provide treatment

Unilateral abstention decision(and possible court involvement)

disagreement

disagreement

disagreement

institution cannot be bound

disagreement

Futility procedure designed by the AMA


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(the attending physician cannot be part of it). The patient (and/or his family)must be informed in advance and in writing of the decision-making procedure andof his (or their) rights in it, and invited to take part in the consultation process.

After having discussed the case, the committee sends a written report of itsfindings to the patient (or family). If the patient (or family) cannot accept theconclusions of the ethics committee, the health care institution helps him (orthem) to find another doctor or institution willing to give the treatment. If after10 days no such provider can be found, the health care institution may decideunilaterally to withhold (or withdraw) treatment that has been determined to befutile, with immunity from civil and criminal prosecution for the institution and

the doctors involved. The patient or family may ask a state court judge for anextension of the 10 days term, to be granted if the judge determines that there isa reasonable probability of finding another health care institution or doctor willingto provide the treatment. If the judge fails to grant an extension, doctors can carryout a unilateral abstention decision with immunity from civil and criminalprosecution.

Kleijers procedure (2005)

The influence of the AMA recommendations extended well beyond the UnitedStates. In 2005, the Dutch health care professional Kleijer designed a decision-making procedure for decisions to abstain from futile life-prolonging treatmentin the case of non-competent patients admitted to a Dutch Intensive Care Unit.49

Kleijers work was directly influenced by the AMA model.

The procedure designed by Kleijer is aimed at solving disagreements betweendoctors and proxy in connection with abstention decisions. The situation thatKleijer has in mind is that of the proxy who demands administration of (further)treatment that IC doctors consider futile. Like the AMA model, Kleijersprocedure gives the last word to doctors in case of persistent disagreement.

In Kleijers proposed procedure, when doctors believe that IC treatment isfutile, they meet the proxy and explain the situation. (Should the proxy requestmore information, a new meeting should be organized.)

The meeting is followed by a health-care team assessment. If there is consensuswithin the health-care team that treatment is futile (or if, in case of lack of


20

49 Kleijer 2005: 203.


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consensus within the team on the point, when the doctor responsible fortreatment has come to the conclusion that treatment is futile after havingconsulted an independent intensivist), doctors meet the proxy.

If the proxy still opposes abstention, Kleijer suggests involving an EthicsCommittee or requesting a second opinion from an independent doctor. If theEthics Committee (or the consulted doctor) comes to the conclusion thattreatment is futile, the proxy should have the chance to transfer the patient toanother institution willing to provide the contested treatment.

If no such institution can be found, doctors should have the power to

withhold (or withdraw) treatment unilaterally. In order to prevent this fromhappening, the proxy can decide to seek a court order and must be given sufficienttime to do so.

The main steps of the decision-making procedure designed by Kleijer arerepresented in the diagram below.


21

Meetingwith proxy

(possibly repeated)

Ethics Committeeor second opinion

New acceptance meetingwith proxy

Attempt to find an institutionwilling to provide treatment

Unilateral abstention decision(after possible court involvement)

Health care team assessment(possible consult indipendent

IC doctor)

Acceptance meetingwith proxy

(possibly repeated)

abstention not accepted

(further) treatments is judged futile

abstention not accepted

institution cannot be found


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50 Kleijer 2005.

22


The procedure engineered by Kleijer is rather close to the American MedicalAssociation model procedure. One important difference, however, is that Kleijerputs more stress on the importance of collective decision-making by the wholehealth care team, including not only doctors but also nurses.

1.5 Conclusions

The medical futility debate has been going on for about 20 years. Attempts tooperationalise the notion of futility proceeded in different directions. During thelate 1980s and early 1990s, futility judgements in individual cases were presentedas purely technical and clinical in nature, and therefore pertaining to doctors aspossessors of technical expertise. From the mid-1990s to the late 1990s, a varietyof general definitions of futility were proposed in the hope that social andprofessional consensus could be achieved. Beginning in the 2000s, the effort tosolve the problem of a substantive definition of futility was more or less abandonedin favour of procedural approaches designed to prevent or to overcome differencesof opinion between doctors and patients or their proxies.These procedures regulatethe powers of doctors and patients or proxies in the decision-making process.

Despite their conceptual differences, the various attempts to operationalisefutility all aimed at maintaining the originalfunction of the notion, that is, givingdoctors the authority to make abstention decisions againstthe will of the patientor representative. The notion of futility represents an attempt by the medicalprofession to defend its professional autonomy.

It is nowadays generally accepted that futility can best be operationalisedthrough a procedure regulating the allocation of decision-making power among the

various actors involved in the decision-making process, giving, under specificcircumstances, the last word to doctors.50 More specifically, in line with the modelof the American Medical Association, the procedure should be aimed at promotingcommunication, seeking consensus and minimizing conflicts between the variousactors (potentially) involved, and at avoiding (where possible) polarization and themobilization of formal legal institutions. In case of irresolvable disagreementbetween doctor and patient, it should be possible to transfer the patient to adifferent institution willing to provide the controversial intervention.


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23

Ch 2 - The regulation of futility in Dutch neonatology

2. THE REGULATION OF FUTILITY IN DUTCH NEONATOLOGY

2.1 Introduction

In the previous chapter, I presented the notion of medical futility as it has beendiscussed in the international literature. My focus now shifts to the Dutchcontext. In particular, I describe the neonatology setting in which end-of-lifedecision-making is practiced in the Netherlands and which has attracted muchattention in the last decade. In particular, I will present the way withholding andwithdrawal of life-prolonging treatment on grounds of futility in neonatologyis regulated in the Netherlands. The current situation can be best understoodwith the help of some insight into the technical and regulative developmentsthat have taken place since the 1970s.

After a brief summary of the ethical issues connected with the new medical-technical possibilities that have become available in the last decades (para 2.2),this chapter outlines the various factors that lead to the decision to regulateabstention on grounds of futility in Dutch neonatology (para 2.3). An accountis given of the process of formulation of rules for abstention in neonatology,which includes a report by the Dutch Association for Pediatrics and one by theRoyal Dutch Medical Association (para 2.4), two Court rulings (para 2.5), areport by a Consultation Group appointed by the Ministry of Health (para 2.6),professional guidelines on abstention in neonatology drafted by the Dutch

Association for Pediatrics (para 2.7) and a professional Protocol regulatingdeliberate ending of life in neonatology that was subsequently adopted as theregulation of this type of decision-making at the national level (para 2.8 and2.9). Some of the sources mentioned, for reasons that will become apparent,

primarily concern deliberate ending of life; however, they are all at leastindirectly relevant in connection with the regulation of abstention. The currentregulation of futility in neonatology in the Netherlands is summarized in para2.10. The chapter includes national (para 2.11.1) and comparative (para 2.11.2)data on the attitude of the medical profession towards end-of-life decisions inneonatology and the frequency of such decisions in medical practice. Finally,para 2.12 draws general conclusions about regulation of abstention on groundsof medical futility.


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1 Carlsson and Svenningsen 1975.2Watts and Saigal 2006.3 In neonates, artificial ventilation can cause damage to the lungs. Compare Donn and Sinha 2006.4 Compare Chase 1967, De Haas-Posthuma & De Haas 1968 with Hoogendoorn 1986, Mackenbach

1992, Treffers 1992.5 Van der Ploeg 2003.

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2.2 The new medical power

In the last few decennia, dramatic improvements have taken place in medicine andmedical technology, and in particular in the field of neonatology. It is nowadayspossible to keep babies alive who, in the past, would not have had any chance ofsurvival. For example, in the mid-1970s a prematurely born baby with agestational age of 29 weeks was considered at the edge of viability. This hadmostly to do with the poor development of the babys lungs.1 Later, technicaladvancements made it possible to apply artificial ventilation to newborn patients.Due to this and other clinical and technological advancements, it is today possible

to keep neonates with a gestational age of 22 weeks or even less alive.2

These babieshave a high chance of developing severe handicaps, partially caused, paradoxically,by the life-prolonging medical treatment itself.3

During the 1970s and the 1980s, neonatal death declined dramatically inTheNetherlands, as it did in other developed countries. On the other hand, thepercentage of severely handicapped babies among all babies significantlyincreased.4

Medical-scientific advances made it possible to predict with more accuracy

the future condition of children hospitalized in Neonatal Intensive Care Units(NICUs). Doctors had new and powerful tools in their hands.The new technicalpossibilities for prolonging life and the new instruments for making outcomepredictions confronted the medical profession with new responsibilities.

2.3 The early history: towards regulation of abstention in neonatology

(the 1980s)

The early history of the regulation of abstention in neonatology described in thepresent paragraph is based on interviews carried out by a Dutch neonatal careprofessional.5


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6 Quotation from R. De Leeuw, Amsterdam Medical Centrum.7 Quotation from P.J.J. Sauer, Sophia Childrens Hospital, Erasmus Medical Centrum, Rotterdam.

8 Reported by C. Versluys, Free University Medical Centrum, Amsterdam.9 F.H.M. Jansen, Haga Ziekenhuis, Juliana Childrens Hospital, The Hague.

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Until the mid-1980s, Dutch neonatal wards did not have institutional policiesregarding decisions to abstain from (further) life-prolonging treatment inneonatology. All there was, were unwritten rules of thumb, which did notguarantee any uniformity or transparency in decision-making at the level of asingle institution, let alone at the national level. In the words of one of theneonatologists directly involved, withdrawing treatment was a completelyarbitrary choice of the doctor that happened to be on shift6 and took place insecret. A neonatologist who worked in a major university hospital reported thefollowing: Doctors knew which nuns were in the ward, and what the views ofeach nun concerning ending of life were. At lunchtime, when most nuns were

away, the matter got taken care of. I still approve of the life-ending decisions thatI carried out then. We did it in the interest of the child.7 Ending the life of anewborn was an almost taboo topic. This was reflected in the modalities ofcommunication between doctors and with the head nurse, consisting of significantstares or hints such as perhaps this patient should not live another day.8

During the 1980s, this situation gradually changed. The medical professionbegan to discuss more openly the indiscriminate application of life-sustainingtreatment to neonates. More and more neonatologists became aware thatprolongation of life is not always in the best interest of the patient. A prominentdoctor reported feeling responsible and guilty about the poor quality of life andsevere suffering of some of the children whose lives he had contributed toprolong.9 It became widely accepted among neonatologists that, in certain cases,withholding or withdrawal of treatment was appropriate.

The initiator of open debate was the neonatologist C. Versluys. In 1987, hewas the first publicly to criticize the triumphalistic belief in progress thatappeared to be dominant in the neonatology setting and that stood in the way ofintroducing transparent policies for limitation of life-prolonging treatment.Versluys had received his professional training at the Medical Centre of the FreeUniversity of Amsterdam, an institution whose original Calvinist orientation hadbecome more relaxed in the course of time. Versluys appeal found support fromthe theologian Kuitert, a professor of moral theology at the same university.


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10 This information is valid as of 4 June 2009.11 See KNMG 1997: XI.

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There were other factors that contributed to the process of regulation ofabstention in the neonatology setting. One was the increasing professionalizationof nurses, which made the nursing profession more conscious of its responsibilities.Nurses abandoned the passive attitude in the decision-making process and theunconditional acceptance of the decisions of the doctors that earlier hadcharacterized their role. With increasing frequency, requests to hold amultidisciplinary meeting to assess whether (further) treatment was in the interestof the baby would come from the nurses.

A second factor was the increasing attention, both within the medicalprofession and among the public, to the rights of the parents of critically illchildren. Parents started to expect a more important role in the decision-makingprocess over abstention and to claim the right to refuse a treatment on behalf oftheir child. The 1980s saw the formation of several associations of parents. Moreand more Dutch mothers and fathers wanted to be present in the unit where theirbaby was hospitalized, and would voice their opinion if they suspectied that acertain treatment was not really in the interest of their child.

A third factor was the reorganization of neonatal care in the Netherlands (part

of a larger project of centralization of specialized health care). In 1987, thegovernment decided that only ten hospitals would be authorized to practiceintensive care on neonates, and would receive abundant subsidies for the purpose.This decison is still in force today.10 Eight of the selected centra are academichospitals (Groningen, Utrecht, Leiden, Nijmegen, Rotterdam, Maastricht, andtwo centra in Amsterdam). The remaining two are general hospitals (Zwolle andVeldhoven). In the selected hospitals, the neonatal care wards were graduallytransformed into high-technology NICUs. In Dutch NICUs, babies are offeredstate-of-the-art, top-level medical care. The NICU health care team comprisesneonatologists, medical assistants, and paramedical personnel specially trained inperinatal care.

The location of the hospitals is shown on the map below.


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Figure 1. NICUs in the Netherlands.The Netherlands is a country ofapproximately 41 square kilometersand of some 16 million inhabitants.

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A case reported by the media in the mid-1980s triggered public debate on theconsequences of the lack of a uniform regulation of abstention at the nationallevel. A woman delivered triplets. The babies were premature and in need ofintensive care. In connection with local shortages of beds, they were admitted tothree different Dutch NICUs. The gestational age and prognosis for all threechildren were identical. However, decisions concerning administration of intensivecare diverged. For one of the babies, abstention was considered.

The public became more conscious of the ethical dilemmas connected with

application of life-prolonging treatment in the NICU. Public debate addressedcriteria of appropriateness in the use of medical technology in neonatology andthe powers of doctors and parents in the decision-making process overadministration of (or abstention from) life-prolonging treatment.

Several experts in the ethical and legal field intervened in the debate. The mostinfluential among the various contributions was that of the theologian Kuitert. Heargued that abstention in the neonatology setting can be ethically acceptable. Inexceptional cases, he maintained that it might even be permissible deliberately to

end the life of a newborn. In Kuiterts view, neonatologists should regard end-of-life decision-making as part of their professional responsibilities.


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12 Utrecht University Medical Centrum.13 P.J.J. Sauer, Erasmus Medical Centrum, Sophia Childrens Hospital, Rotterdam.

14 F.H.M. Jansen, Haga Ziekenhuis, Juliana Childrens Hospital, The Hague.15 L.A.A. Kollee, University Medical Centrum St. Radboud, Nijmegen.

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In short, by the mid-1980s the time seemed ripe for regulating end-of-lifedecisions in neonatology at the national level. Legal developments in the early1980s had clarified the legal status and regulation of end-of-life decisions forcompetent patients but left unresolved the problem of regulation of end-of-lifedecisions in the case of incompetent patients.11 Elaboration of a procedure fordecision-making over administration of life-prolonging treatment to newbornsbecame one of the priorities of the Dutch Association for Pediatrics (NVK) and ofthe Royal Dutch Medical Association (KNMG). Both the NVK and the KNMGappointed special committees whose task was to formulate recommendationsconcerning end-of-life decisions in neonatology.

2.4 The formulation of rules by neonatologists: Doen of laten?(1986-1992)

The Working Group

Already during the 1970s, members of the NVK had formed a PerinatologySection. Its members met on a monthly basis to discuss particularly challengingclinical cases and new developments in perinatology. Within the Perinatology

Section, there was an atmosphere of strong cohesion and cooperation.In 1986, the Perinatology Section of the NVK appointed a Working Group onEthical Aspects in Neonatology. It was expected to draft guidelines regulating end-of-life decisions in neonatology, reflecting the position of Dutch pediatricians asa professional group.

The Working Group consisted of six neonatologists with different ideologicalbackgrounds. It was presided over by C. Versluys,12 a progressive Calvinist. Othermembers were a professor whose background was similar to Versluys,13 two

doctors of Catholic persuasion (one with a more liberal14 and one with a moreconservative orientation15), a doctor with a communist background,16 and aprotestant with a conservative orientation.17 This pluralistic composition reflectsa traditional feature of Dutch political culture, characterized by consultation andpacification. Dutch social structure from the beginning of the twentieth century


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16 R. Leeuw, Amsterdam Medical Centrum.17 H. Wierenga, Wilhelmina Ziekenhuis, Assen.18 Griffiths, Weyers and Adams 2008: 13-14.19 This early version of the report was published in 1990 (CAL 1990). However, the official publication

of all reports of the Commission of the KNMG was only issued in 1997 (KNMG 1997). For a full discussionof the CAL report, see Griffiths, Bood and Weyers 1998: 118-134.

20 NVK 1992: 19.21 NVK 1992: 23-25.

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until the 1960s can be described with the term pillarization, that is, theorganization of social institutions around the so-called ideological pillars ofsociety. Dutch society consisted of a Catholic pillar, a Calvinist pillar and asecular one (consisting of a socialist and a liberal bloc). Each pillar had its owntrade unions, schools, media, hospitals, etc. The Dutch elites practiced pragmatictoleration, and political negotiations between pillars on major issues of generalsocial relevance took place on the basis of what was seen as the common good.18

At about the same time, in the mid-1980s, the Royal Dutch MedicalAssociation (KNMG) appointed a Commission on the Acceptability of End-of-lifeDecisions (CAL) whose mandate covered several categories of not (entirely)competent patients. The first CAL report, issued in 1990, dealt with severelydefective newborns.19 Because the CAL commission and the NVK Working Groupclosely cooperated and heavily influenced each other, the conclusions of the tworeports are very similar. I therefore limit the following description to the NVK.

A picture of medical practice

First of all, the Working Group tried to get a picture of medical practice byreviewing the existing hospital policies on abstention in neonatology. By 1987,four of the eight Dutch academic hospitals had written protocols regulatingabstention decisions in neonatology. Expectations for the babys future quality oflife played a central role in all of the protocols.20

On the basis of data emerging from this preliminary review, the groupelaborated definitions for the various types of end-of-life decision that appeared totake place in neonatal practice.These definitions are as follows. Deliberate endingof life is the decision to end the life of the baby by means of a lethal injection.Withholding of treatment is the decision not to initiate a life-prolongingtreatment, such as resuscitation for a cardiac arrest. Withdrawal of treatment is thedecision to stop a life-prolonging treatment, such as artificial ventilation.21


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22 NVK 1992: 29.23 NVK 1992: 41.

24 NVK 1992: 23.25 NVK 1992: 37. See Griffiths, Bood and Weyers 1998: 120-123.

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The report further defines some concepts that are central in the end-of-lifedebate in neonatology:

Doctor responsible for treatment.As a general principle of Dutch health law, thereis one doctor primarily responsible for treatment decisions for a particularpatient. This is what in the English literature is called the attending physician.

Life not worth living. The report specifies in detail the criteria that define a lifenot worth living. In this book I am going to use the phrase quality of life,more commonly found in international literature.

Requirements of careful practice. The doctor who performs an end-of-life decision

is expected to comply with a number of requirements. As we will see, there aredifferent sets of requirements, according to the sort of behavior they apply to.

Medical futility: kansloos and zinloos

In line with Kuiterts views, the Working Group came to the conclusion thatdecisions to abstain on grounds of futility are part of the professionalresponsibilities of a neonatologist. The doctor, who is responsible for the decisionto apply a life-prolonging treatment in the first place, should also assume

responsibility for the decision to limit or stop it when there are reasons for doingso (for example, if treating would lead, or has already led, to an unacceptableoutcome).22

The Working Group held that there is no ethical difference betweenwithholding of treatment and withdrawal of treatment.23 It sought to clarify thenotion of medically futile treatment by introducing a distinction between zinloosand kansloostreatment. Medical treatment is kansloos(no chance of success) if thebaby has no chance of survival and zinloos(or meaningless) if the expectations

for the babys future are so poor that treatment would be pointless.24 The reportturned on its head what had previously been a strong assumption in the debateover abstention: it argued that because medical treatment constitutes an invasionof physical integrity, it is not its withholding or withdrawal that requires

justification, but rather its initiation or continuation.25


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26 KNMG 1997: 77. I have chosen to report these criteria as they are formulated in the KNMG report.

The formulation in Doen of Laten is less sharp and clear, although substantially the same in content.27 NVK 1992: 32.

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Criteria for decision-making

The Working Group maintained that abstention can be decided upon only if thehealth care team has reached a consensus over diagnosis, prognosis, and theinadvisability of (further) treatment. But, at the same time, it emphasized thatconsensus does not mean unanimity.

The choice for or against (further) treatment should be primarily based uponthe condition of the baby at the time the decision is made. However, the babyspredictable future handicaps and suffering should be taken into account as well.The group outlined a number of criteria that, taken together, constitute an

operationalization of the idea of futility:- expected extent of suffering (permanent functional impairments, pain and

anxiety, prospects for the future and room for hope),

- life expectancy,

- burden of further treatment,

- expected possibilities of communication (both verbal and non-verbal) andinterpersonal contact,

- expected possibilities of self-sufficiency (capacity to sit, walk, live, and take careof onesel

moratti_dissertatie

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