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This discussion paper was prepared for the Council's March 2009 meeting. It was prepared by staff solely to aid discussion, and does not represent the official views of the Council or of the United States Government.

 

STAFF Discussion PAPER

Beyond Medical Rescue
By Joseph A. Raho and
Dan Davis, Ph.D.


Introduction

The purpose of this document is to provide a basis and “stimulus” for Council discussion of the topic of medical futility. To date, there have been five presentations to the Council, along with the ensuing discussions. At the September 2008 meeting, there were two presentations: (1) a clinical and ethical survey of the topic by Linda Emanuel, M.D., Ph.D. and (2) a survey of institutional and legal approaches to futility by Thaddeus Pope, J.D., Ph.D. At the November 2008 meeting, we continued discussions of the topic with (3) a defense of unilateral physician decision making following the determination of quantitative or qualitative futility by Lawrence Schneiderman, M.D.; (4) an analysis of five themes that often surface in futility conflicts—the themes of power, trust, money, hope, and suffering—by Robert Truog, M.D.; and (5), a defense of the critical, determinative role of patient values and preferences in futility situations by Susan Rubin, Ph.D.

Our hope is that Council discussions during the session on Friday, March 13 will resolve three questions:

  • First , is there agreement that the Council has something useful to contribute to debates about medical futility?
  • Second , if so, what should the “thrust” of that contribution be?
  • Third , is there support among members for the idea of joining conscience and futility in one white paper for publication?

With respect to the first and second questions, after providing a succinct description of the background to this topic, this document summarizes the presentations at the November 2008 meeting by Lawrence Schneiderman, Robert Truog, and Susan Rubin and uses a case to imagine varying approaches to futility from the respective perspectives of these guest speakers. This summary offers a point of departure for Council discussion—not an iron-clad framework within which discussion must proceed.

With respect to the third question, we pose it for the following reasons. Both inquiries—into conscience and into futility—originated in the broader discussions that we initiated under the rubric of an alleged “crisis of professionalism” in September 2006. Under that rubric, we began to explore the mounting anxieties, within and beyond the medical profession, about the apparent loss or erosion of its moral bearings. Those who contend that contemporary medicine is adrift in moral malaise have cited various causes: the supplanting of the patient's good by financial self-interest and commercial values in clinical judgment; the complicity of physicians in such practices as torture and capital punishment; the triumph of patient autonomy as the overriding, prevailing “principle” of ethically valid clinical decision making and the seeming willingness of some physicians to relegate themselves to the status of technical facilitators of our desires for happiness—be it the happiness to be found in longer lives, or in more attractive bodies, or in perfect children.

There may be evidence of each cause in this differential diagnosis of medicine's moral malaise, but all, in our view, raise other, perhaps more fundamental questions, such as: In what , specifically, should physicians—as members of a profession—find their moral bearings?

  • In certain duties, obligations, or responsibilities that are held to define the profession as such and are, at least presumptively, incumbent on every member of the profession?
  • In certain clinical virtues critical to realizing the ends of medicine in day-to-day practice?
  • In fidelity to certain moral precepts, identified and embraced through a lifelong process of conscience formation?

There are, moreover, obvious parallels between the topics of conscience and futility. Each is a matter of considerable controversy within the profession and the public—controversy that seems fueled, in part, by confusion on the part of the public and professionals alike. Claims of conscience by professionals are often held to be at odds with purportedly “weightier” duties or obligations to patients. The compelled provision of allegedly futile treatment is often characterized as a violation of the conscience of physicians and nurses, and of the integrity of the health professions. It is often argued, as well, that physicians are under no obligation to provide futile treatments—and, indeed, may be obligated to refuse to provide such treatments—just as they are seemingly freed from the obligation to provide services to which they have moral objections. In brief, there are clear resonances between conscience and futility that may offer a basis for a combined treatment of both topics in one white paper.

There may be, as well, disadvantages or countervailing reasons for this proposal. We believe, however, that if one likens the moral bearings for the profession to a map, we could foresee a document that seeks to identify and clarify certain coordinates on that map. Conscience would be one such coordinate; others would, perhaps, include certain duties related to the problem of futility—that is, the duty to determine effectiveness, the duty to respect patient values and preferences, and the duty to engage in respectful, shared decision making.

I. Beyond Medical Rescue: Background

The “birth” of Western medicine is recorded in the Hippocratic Corpus , a collection of writings—including the famous Oath —that have lost none of their original capacity to fascinate and inspire. Many of the treatises therein extol the superiority of natural, rational explanations of disease and describe and defend natural, rational approaches to therapy; but some, at least, also couple this confidence and conviction with an awareness of the limits of medicine. After defining medicine “as the complete removal of the distress of the sick and the alleviation of the more violent diseases,” the unknown author of the treatise, The Science of Medicine , counsels physicians to refuse “to cure cases in which the disease has already won the mastery, knowing that everything is not possible to medicine.”1 Everything is not possible to medicine: today, this ancient wisdom—that age, disease, or injury may carry a patient to a point beyond medical rescue —is challenged by and at stake in conflicts that are often grouped under the broad, at times confusing rubric of futility—conflicts that often pit physicians against patients and that have spawned the spread of organizational ethics committees as well as judicial and legislative resolutions. In the following, we briefly describe highlights in the history of futility by way of background to the summaries of the perspectives offered in testimony before the Council, especially at its November 2008 meeting.

A. The Growing Effectiveness of Medicine: A Century and More of Progress

To some extent, today's futility conflicts are by-products of the stunning effectiveness of contemporary medicine in its capacity to cure some diseases, to ameliorate the course and impact of many, to sustain or replace critical physiologic functions with sophisticated technologies, and to ease the pain and discomfort that often accompany acute as well as chronic disease. Although effectiveness has arguably been the desideratum of western medicine since its Hippocratic beginnings, it was not until the 20 th Century that progress in the sciences and technology of human health and disease began to yield practical successes. In 1905, artificial hip joints and direct blood transfusions first became possible; in 1913, the first extracorporeal kidney was developed and fourteen years later, the first iron lung. A critical breakthrough was Alexander Fleming's discovery of penicillin in 1929 and within ten years of that, the first vaccine to combat yellow fever. In the next several decades, a series of innovations and developments led to the emergence of a new medical specialty—the specialty of critical care medicine. Mechanical ventilation for poliomyelitis was invented in the 1950s, the military conducted pioneering research in the resuscitation of shock victims from the Korean and Vietnam wars, cardiopulmonary resuscitation was developed, and the first intensive care units were established in the 1960s.

B. The Fruits and Quandaries of Progress

 

Significant Developments in Medicine
(1940-1970)

Year

Invention

1943

First kidney dialysis machine

1951

First heart-lung machine

1952

Vaccine against polio; first artificial ventilator

1953

First ICU

1954

First successful kidney transplant

1963

First human liver transplant

1967

First aortocoronary bypass operation; first human heart transplant

One of the significant achievements of this era was the development of hemodialysis by Willem Kolff, but the consequent increase in demand for its use generated a type of question that, for many, heralded the advent of the field of bioethics: Who should receive treatment with such a scarce medical resource? This, of course, was not the only question around which bioethics took shape. The new life-sustaining technologies, the whole emerging armamentarium of critical care medicine, compelled physicians and nurses, as well as patients and their families, to ask about the conditions and criteria for their use—and to seek guidance and wisdom from various sources, religious, scientific, and political. For example, a group of anesthesiologists looked to Pius XII for guidance on the topic of mechanical ventilation and, in 1957, Pius issued a statement2 identifying the obligations related to resuscitation and, by implication, similar life-sustaining therapies. In his statement, he addressed three questions: (1) Whether one has the right or is obligated to use artificial respiration in all cases, even in cases in which the physician has determined is hopeless; (2) whether there is a right or obligation to remove artificial respiration if, after several days, unconsciousness does not improve, and in so doing the circulation will stop within a few minutes; and (3) whether patients who are unconscious after several days can be considered de facto or de jure dead, even if circulation is being maintained through artificial respiration.

With these questions in mind, Pius outlined several guiding moral principles. He first drew a distinction between ordinary care, which is morally obligatory, and extraordinary care, which is morally optional, reasoning that “[…] normally one is held to use only ordinary means—according to circumstances of persons, places, times, and culture, that is to say, means that do not involve any grave burden for oneself or another. A more than strict obligation would be too burdensome for most men and would render the attainment of the higher, more important good too difficult.”3He then considered the rights and duties of physicians. “Does the anesthesiologist have the right, or is he bound,” he asked, “in all cases of deep unconsciousness, even in those that are considered to be completely hopeless in the opinion of the competent doctor, to use modern artificial respiration apparatus, even against the will of the family?”4He responded that

In ordinary cases one will grant that the anesthesiologist has the right to act in this manner, but he is not bound to do so, unless this becomes the only way of fulfilling another certain moral duty. […] On the other hand, since these forms of treatment go beyond the ordinary means to which one is bound, it cannot be held that there is an obligation to use them, nor, consequently, that one is bound to give the doctor permission to use them. […] Consequently, if it appears that the attempt at resuscitation constitutes in reality such a burden for the family that one cannot in all conscience impose it upon them, they can lawfully insist that the doctor should discontinue these attempts, and the doctor can lawfully comply. […] Even when it causes the arrest of circulation, the interruption of attempts at resuscitation is never more than an indirect cause of the cessation of life, and one must apply in this case the principle of double effect and of “voluntarium in causa.”5

Pius could offer no clarity, however, on the life or death status of certain patients—those who seemed to be permanently unconscious. He explained that “Where the verification of the fact in particular cases is concerned, the answer cannot be deduced from any religious and moral principle and, under this aspect, does not fall within the competence of the Church. Until an answer can be given, the question must remain open.”6 The scientific community vigorously debated this question, and it is to this question—the “definition” of death—that we now turn.

The mixed blessings of the new life-sustaining technologies became all too evident with the spread of their use. This was especially the case with the use of mechanical ventilation to sustain individuals suffering from serious brain injuries. Experience with these individuals seemed to challenge the traditional standard for determining the death of a human being, the cardiorespiratory standard that defines death as the irreversible cessation of either cardiac or pulmonary function. Meeting from January through August of 1968, the Harvard Ad Hoc Brain Death Committee convened to analyze and reflect on this experience and, in the process, fashioned the beginnings of another standard for determining death—the neurological standard, which defines death as the irreversible loss of brain function. The new definition did not resolve the questions surrounding profoundly disabled patients on life support. Indeed, the ongoing confusion prompted the U.S. Congress to charge the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to explore more fully the ethical and legal implications of defining death and the potential for some uniform definition—a mandate that led to the Commission's 1981 report, Defining Death.

In another of its landmark reports, Deciding to Forego Life-Sustaining Treatment , the President's Commission turned its attention to yet another related problem involving the status of disabled patients and the duties and obligations of health professionals. One of the pressing questions here was whether it is permissible to discontinue life-sustaining treatment in patients in persistent vegetative states (PVS)—and it was in the conflict of responses to this question that our more recent debates about medical futility were born. Indeed, between 1976 and 1990, patients in PVS were at center stage in seve ral high-profile legal cases—cases that many characterized as blows to the traditional paternalism of the medical profession. The first was the ruling of the New Jersey Supreme Court in the case of Karen Ann Quinlan, i.e. , that life-sustaining medical treatments may be refused by patients or their surrogates/guardians, even if such refusals lead to the death of the patient, because such refusals are legally and morally grounded in the right to privacy and self-determination. Fourteen years later, similar questions finally received a hearing in the highest court in the land, in the case of Nancy Cruzan; here, too, the U.S. Supreme Court recognized a constitutionally-based right to refuse life-sustaining treatments.

The Quinlan case was one of several catalysts to two subsequent, signal developments in bioethics: the enactment by the states of advance directives legislation, especially encouraging and legalizing the so-called “living will,” and the establishment and proliferation of organizational (usually hospital) ethics committees to mediate and decide increasingly frequent disputes about life-sustaining treatment. These rapid developments set the context for the previously mentioned 1983 report by the President's Commission, Deciding to Forego Life-Sustaining Treatment. Although it largely focuses on the ethics of refusals of life-sustaining treatments, underscoring a presumption in favor of preserving life (as well as highlighting the determinative role of patient values and preferences), the report incipiently looks forward to the thorny questions that began to emerge in futility debates—debates that are often less about refusing and more about demanding life-sustaining treatments. The report does so by considering possible constraints on patient values and preferences and their expression in decisions about life-sustaining treatment—among such constraints, the report noted violations of conscience or professional judgment and the goal of achieving a more equitable use of scarce medical resources.

The concerns that patient demands for purportedly futile treatment violate professional conscience and judgment, and that such demands, if satisfied, will waste precious human and physical resources, are of course the “stuff” of today's futility conflicts—some portion of which become intractable. Although these cases were not futility cases per se , the 1991 case of Helga Wanglie, the 1994 case of Baby K, and the 1995 case of Catherine Gilgunn all involved such intractable disputes about demands for life-sustaining treatment—disputes that pitted patients and families against physicians and hospitals. They made clear the fundamental shift that was then underway and raised a key question: the shift in emphasis from refusals of, to demands for, life-sustaining treatment and the question of whether the same logic that supported refusals of treatment—that such refusals are appropriate if consistent with patient values and preferences—can be marshaled in support of demands for treatment.

II. Debates about Futility

All human beings are mortal. The human condition is such that at some point in our lives, whether due to age, disease, or trauma, each of us will be beyond medical rescue. No therapeutic intervention will be able to cure or ameliorate our mortal ills and thereby save us from the fate that awaits each and every one of us at that point—the fate of dying and death. Medical interventions at and beyond this point have been described as “inappropriate,” “ineffective,” “non-beneficial,” or contrary to the “standard of care”—and perhaps, in the most controversial way, as “futile.” “Futility” comes from the ancient futilis , meaning “leaky, vain, failing of the desired end through intrinsic defect.”7 When a patient is beyond medical rescue, further medical intervention will not achieve “the desired end”: the disease or injury will not be reversed or the anticipated benefits of intervention will be far less than its risks and burdens.

Although today's controversies over medical futility are complex and resistant to easy analysis and summary, there are, in general, several dominant positions. There are those who contend that futility can be defined objectively in the concrete circumstances of a given case and on the basis of this objective determination, a physician may unilaterally withdraw or withhold treatment. By contrast, there are those who contend that futility is an unavoidably subjective concept, inflected with judgments of value rather than judgments of fact and, as a result, there is no ethically valid basis for unilateral decision making by physicians, either in imposing or withdrawing/withholding treatment. There are, as well, those who underscore the probabilistic nature of all clinical judgment and the unavoidable uncertainty of medical practice, especially in prognosis, while pointing to the inescapable connotations of futility—the connotations of hopelessness, neglect, and abandonment. Some advocate the elimination of the term; others look to procedural, rather than substantive solutions to the futility conflicts that often provide ethics committees with their raison d' être.

III. Framing the Council's Discussion

First, does the President's Council on Bioethics have anything of value to bring to today's debates about futility? Second, if so, what would the thrust of its contribution be? If the answer to the first question is “yes,” in response to the second, there are several possibilities. One would be to throw into relief the contending positions now arrayed around each question. Another possible contribution would be to clarify certain concepts, particularly those invoked in the evaluation of therapeutic interventions—especially the concept of futile treatment, but also the related concepts of appropriate treatment, of effectiveness , and of the standard of care . And a third possible contribution would be to spell out the implications of these concepts and these contending positions for our understanding of (a) the obligations incumbent upon physicians, nurses, and other health professionals as professionals, as men and women who profess and promise to heal and to care for the sick; and (b) the needs and responsibilities of patients, their families, and those entrusted with the task of making crucial decisions about treatment and care on behalf of patients unable to make these decisions themselves.

We propose that the Council grapple with these questions by discussing and reflecting on (1) summaries of the perspectives offered by the three guest speakers at the November 2008 meeting, i.e. , Lawrence Schneiderman, Robert Truog, and Susan Rubin, and (2) a futility case.

A. The Testimonies of Schneiderman, Truog, and Rubin

1. The Perspective of Lawrence Schneiderman

In his testimony to the Council,8 Lawrence Schneiderman argued that medical futility disputes involve questions about the obligations physicians have to patients (based on an understanding of the medical profession); the limits to those obligations; and the relationship between the profession and society.

According to Schneiderman, physicians have a patient-centered obligation to deploy treatments that lead to “improvement of the patient's prognosis, comfort, well-being, or general state of health.”9 If medical treatments are unable to produce improvement, the treatment is futile and further treatment should not continue. The noun “futility” and the adjective “futile” refer then to “any effort to achieve a result that is possible but that reasoning or experience suggests is highly improbable and that cannot be systematically produced.”10

There are, according to Schneiderman, two alternative, objective definitions of futility, each offering an independent basis for withholding or withdrawing treatment:

  • Quantitative futility : This definition of futility rests on calculations of probability—the probability that a given medical intervention has of being clinically in effective. According to Schneiderman and his colleagues, “when physicians conclude (either through personal experience, experiences shared with colleagues, or consideration of reported empiric data) that in the last 100 cases, a medical treatment has been useless, they should regard that treatment as futile.”11
  • Qualitative futility : This definition of futility rests on the argument that many life-sustaining medical interventions have a strong possibility of working—that is, they may be effective in sustaining physiologic functioning—but such treatments do not provide a tangible benefit to the patient as a whole ( i.e. , either cure, ameliorate the illness, or reduce pain and suffering in the patient). Schneiderman and colleagues argue that “any treatment that merely preserves permanent unconsciousness or that fails to end total dependence on intensive medical care should be regarded as nonbeneficial and, therefore, futile.”12

Schneiderman has received much criticism of his patient benefit-centered approach. In his defense of his position,13 he restates the importance of explicit quantitative and qualitative thresholds. With quantitative futility, the point is not so much that the medical intervention does not have a “remote possibility” of being effective, but rather, that it has such a low probability of working that it is not worth the attempt. With qualitative futility, by contrast, Schneiderman argues against others who suggest that medical futility must be based on an assessment of whether a given intervention will be able to complete the function for which it is intended to serve (also called physiologic , scientific , or strict futility). Schneiderman contends that the purpose of medical interventions and treatments is not to merely sustain a biological part of the patient's body, but rather, to produce a benefit that the whole patient can appreciate.

2. The Perspective of Robert Truog

In his remarks to the Council,14 Robert Truog offered a differential diagnosis of futility disputes as a means of clarifying the substantive difficulties at play in such disputes. For Truog, futility conflicts are, more often than not, conflicts about power, trust, hope, money, and suffering. Such conflicts cannot be resolved on the basis of rules or definitions but must, instead, be approached on a case-by-case basis. When intractable conflicts arise, fair processes—such as those described in the policies of Children's Hospital in Boston or available through the courts—are the only ways of dealing with such conflicts effectively. To summarize Truog's differential diagnosis:

  • Conflicts of power (or authority) are, perhaps, unavoidable in futility disputes in light of the inherent inequalities of the physician-patient relationship. Truog identifies questions of power that often emerge in such conflicts from their relative perspectives: for example, “Do patients have a right to force physicians to squander time and resources on therapies that have no benefit in order to satisfy their irrational desires?” And on the other hand, “Do doctors have a right to arbitrarily ignore the values and preferences of patients and family members using their own value systems to make life and death decisions for others?” In light of a debate over “odds” (what chance of success is “worth it”) and “ends” (what quality of outcome is “worth it”?), Truog asks whether physicians may appropriately assume the power to determine the issue of worth.
  • Conflicts of trust are a function of two factors. First, most conflicts over medical futility arise with patients from more marginalized backgrounds ( e.g. , in the case of baby Rauol described by Truog or in the well known Texas case of Emilio Gonzales). Second, clinical judgment is inherently probabilistic and therefore uncertain: “Even if we could agree on a statistical cutoff point for determining futility, physicians are often highly unreliable in estimating the likelihood of success of a therapeutic intervention.”15 In light of these two factors, Truog asks whether our clashes over futility are really “the product of a severe breakdown of trust in the relationship between the clinicians and the patient's family”16 and he observes that “Even in the best circumstances, physicians often communicate poorly, and this deficiency is exacerbated when the communication must occur across the gaps created by language, class, and culture.”17
  • Conflicts over hope involve a paradox: although unrealistic hopes can interfere with good decision making and good patient care, such hopes, nonetheless, must be brought to the fore and integrated into clinical decision making. Truog believes that “If the patient's goals appear to reflect unrealistic expectations about the probable course of the underlying illness or the probable effect of medical interventions, providers should attempt to correct those impressions.” 18 The problem, of course, is when patients remain unconvinced. To this, Truog asks, “For those in an ICU where death is the only alternative, is any chance of success too small?”
  • Conflicts over money creep into clinical judgment when practitioners feel motivated to limit the use of marginally beneficial, but expensive treatments. If physicians label these kinds of treatments as futile, they are implicitly rationing treatments that have a remote possibility of working— i.e. , of being as least physiologically effective. For Truog, “Since rationing policies make explicit the values and probabilities that futility-based arguments leave implicit, it is clearly preferable to develop and adopt them rather than use futility arguments as a cover for limiting the availability of scarce and expensive resources.” 19
  • Conflicts over suffering arise for patients, their families and the professionals caring for them. On the one hand, “clinicians often justify their efforts to override the requests of family members by claiming that the continued use of life support is causing the patient unwarranted suffering or is contributing to an undignified death.” 20 In response, he believes that in some cases—for example in the use of mechanical ventilation—patients may be given adequate doses of analgesics and sedatives to reduce pain and suffering, and their capacity to experience such pain actually diminishes as their condition worsens. By contrast, Truog believes that families may suffer equally as much as other health care professionals. In the case of Emilio Gonzales, the 18-month-old boy with Leigh's disease, Truog has argued that “regardless of whatever objections the clinicians may have had about the dignity of his death, his mother and others who spent time at his bedside clearly felt that his life was still dignified.”21

Ultimately for Truog, the concept of futility is unhelpful because it “obscures many ambiguities and assumptions”22 and “generally fails to provide an ethically coherent ground for limiting life-sustaining treatment, except in circumstances in which a narrowly defined physiologic futility can be plausibly invoked.”23 As medical interventions must be assessed in relation to the goal of treatment, Truog believes that “The decision that certain goals are not worth pursuing is best seen as involving a conflict of values rather than a question of futility.”24 Therefore, in attempts to solve any clash over values, Truog believes that we must first clarify and evaluate the five elements of the differential diagnosis. Beyond these five considerations, Troug believes that “clinicians may justify their refusal to treat on the basis of their right to refuse to participate in medical interventions that they believe violate their moral integrity.”25 But this last consideration is important on his account—for refusing to participate in a particular medical situation out of a sense of professional integrity is different from refusing to participate based on a determination of the “futility” of the intervention. This latter case, at least for Truog, “has proved to be elusive, however.”26

3. The Perspective of Susan Rubin

In her remarks before the Council,27 Susan Rubin argued that although the concept of medical futility is routinely invoked in clinical decision making today, the underlying conceptual and practical issues are not resolved. For Rubin, the concept of medical futility will not do the work that its proponents believe it does: it does not provide a sound rationale for unilateral decision making on the part of physicians against the wishes of the patient or family.28 Resolving “futility” conflicts requires frank discussion of the underlying values and goals; such conflicts cannot be resolved with futility policies, professional position statements, or futility statutes. When genuine and persistent conflict remains, Rubin argues that a fair process should be deployed to address the issues as they arise.

Rubin's perspective is responsive to the following questions: (1) Who should decide when to start and stop treatment; (2) what sort of values and whose values should be determinative; and (3) are determinations of futility medical or moral decisions?

  • Who should decide? For Rubin, all medical decisions turn fundamentally on values—either the values of the individual physician, the medical profession at large, or the values of patients and their families. These values may not be universally shared within the professional or lay community.29 Physicians and their patients may have different assessments of the risk, benefit, and the appropriateness of a particular intervention. As these underlying values often conflict, Rubin ultimately argues that unilateral decision making must be replaced with shared decision making.
  • What sort of values should be determinative? For Rubin, the generalization of expertise argument shows that physicians may not validly generalize from their knowledge of medical facts to another kind of knowledge—that of medical values. Strictly speaking, physicians may recommend various medical treatments based on effectiveness but they may not determine which treatments are “worth pursuing.” This assessment is reserved for patients or their surrogates. Deference, therefore, should be given to patients and families in deciding whether to start or stop medical treatments.
  • Is medical futility a medical or moral decision? For Rubin, medicine is not only a science, but also an art that is characterized by uncertainty. Because a determination of medical futility is based in reference to a particular medical goal (which is shaped unequivocally by values), the decision is ultimately moral, not medical.

On Rubin's account, medical futility is an instrumental concept that depends on the goals of medical treatment. Deciding whether a particular medical treatment is indicated or contraindicated cannot be based, therefore, on science and the medical facts alone.30 As the goals of treatment require different kinds of expertise and authority (both an assessment of what is medically possible and an understanding of the wishes of patients), Rubin proposes a subjective-objective assessment plan (SOAP) to account for and mediate these different perspectives. Understanding the patient's values, goals, and wishes therefore becomes central to determining which course of medical treatment should be pursued—as in the example she provides of the two women diagnosed with the same metastatic cancer with identical prognoses, but divergent treatment goals and values.

Rubin readily acknowledges the ubiquity of medical futility determinations,31 but argues that these determinations often conflate fact and value, and overlook the evaluative assumptions inherent in these decisions. To remedy this, Rubin proposes further transparency in the clinical encounter and a return to the Imbus and Zawacki model of decision making32 that would explore early on the various goals and values both of physicians and patients and their families. The discussion would be a genuine conversation in order to engage and make transparent the values at stake, thereby connecting the “medical data” with the “values data.”33 Although acknowledging that conflicts arise invariably, Rubin asks that we continue to explore the values that conflict. By proposing an open-ended discussion, Rubin believes that a majority of cases of intractable conflict will be averted and those rare cases that will not resolve should be adjudicated by the courts.34 For Rubin, the real mistake of the futility debate is that it makes “the mistake of imposing our views of a good death, of lives worth living, of battles worth fighting, of risks worth taking, or of suffering worth enduring uniformly across the patient population, a population which we know to be profoundly diverse.”35

B. Case presentation 36

The patient was a five-year-old boy (for purposes of our analysis, we believe that he could have been an adult) who fell two stories. Respiratory distress developed while he was in the emergency room, and he was intubated and transferred to the pediatric intensive unit.

Despite maximal ventilatory support, adequate oxygenation could not be maintained. Extracorporeal membrane oxygenation (ECMO), involving a heart- and lung-bypass machine that is now considered standard therapy in older children and adults, was proposed as a last-stage heroic measure to improve the patient's pulmonary status. The family agreed to a two-week trial to see whether the therapy would allow time for his lungs to recover.

Even with ECMO, the patient's condition continued to deteriorate. Although he had been alert when placed on the lung-bypass machine, by day 8 he was noticeably less responsive. In addition, his renal function began to fail, requiring dialysis, and there was evidence of liver dysfunction. On day 13, a brief trial of conventional ventilatory therapy was attempted. Within 20 seconds after ECMO had been interrupted, the patient had bradycardia and hypoxemia. In light of these results, the use of ECMO to allow pulmonary recovery was considered unsuccessful. The parents were informed that there was no indication of improvement in the patient's pulmonary condition and that the therapy would therefore be stopped.

The parents strenuously objected to the withdrawal of what was, in effect, a life-sustaining therapy. They did not want their son to die. Furthermore, they threatened to call their lawyer and to bring a malpractice suit against the hospital and physicians if the therapy was withdrawn.

_______________________

EndNOTES

1. Unknown author, “The Science of Medicine,” in Hippocratic Writings , ed. by G.E.R. Lloyd, trans. by J. Chadwick and W.N. Mann (New York, Penguin Books, 1983), 140.

2. Pope Pius XII, “The Prolongation of Life,” in Artificial Nutrition and Hydration and the Permanently Unconscious Patient: The Catholic Debate , ed. Ronald P. Hamel and James J. Walters ( Washington , D.C. , Georgetown University Press, 2007), 91-97.

3. Ibid ., 94.

4. Ibid ., 95.

5. Ibid ., 95-6.

6. Ibid ., 97.

7. Lawrence J. Schneiderman and Nancy S. Jecker, Wrong Medicine: Doctors, Patients, and Futile Treatment (Baltimore, Johns Hopkins Press, 1995), 19.

8. See the transcript, available at http://www.bioethics.gov/transcripts/november08/session1.html.

9. Lawrence J. Schneiderman, Nancy S. Jecker, and Albert R. Jonsen, “Medical Futility: Its Meanings and Ethical Implications,” Annals of Internal Medicine 112 (1990): 949-954; 950.

10.Ibid ., 951.

11. Ibid . Although any number will appear arbitrary, these authors argue that the number selected corresponds to a slim, 1% chance of likelihood (95% confidence interval— i.e. , 3 successes per 100 trials is the upper limit of the 95% CI).

12. Ibid ., 952. The authors provide other examples: “conditions requiring constant monitoring, ventilatory support, and intensive care nursing […] or conditions associated with overwhelming suffering for a predictably brief time.”

13. Lawrence J. Schneiderman, Nancy S. Jecker, and Albert R. Jonsen, “Medical Futility: Response to Critiques,” Annals Internal Medicine 125 (1996): 669-673.

14. See the transcript, available at http://www.bioethics.gov/transcripts/november08/session2.html.

15.Robert D. Truog, Allan S. Brett, and Joel Frader, “Sounding Board: The Problem With Futility,” New England Journal of Medicine 326 (1992): 1560-1563; 1561.

16. Robert D. Truog, “Tackling Medical Futility in Texas ,” New England Journal of Medicine 357 (2007): 1-3; 1.

17. Ibid .

18. “The Problem With Futility,” 1562.

19. Ibid .

20. “Tackling Medical Futility in Texas ,” 1.

21. Ibid .

22. “The Problem With Futility,” 1560.

23. Ibid ., 1563.

24.Ibid ., 1561.

25. “Tackling Medical Futility in Texas ,” 2.

26. “The Problem With Futility,” 1560.

27. See the transcript available at http://www.bioethics.gov/transcripts/november08/session3.html .

28. Rubin rejects both physiologic futility and evaluative futility. See Susan B. Rubin, When Doctors Say No: The Battleground of Medical Futility (Bloomington, Indiana University Press, 1998).

29. See When Doctors Say No , 67: “Just as there is no consensus regarding appropriate definitions and goals, so too there is no consensus regarding acceptable substantive criteria for the recognition of evaluatively or factually futile treatments. This failure to establish consensually agreed upon answers to the epistemological problems of defining futility and establishing criteria by which it can be recognized raises serious questions about the legitimacy of the normative position that supports physician unilateral refusal to provide requested treatment on the grounds of futility. That physicians are in the best position to make futility judgments and that they employ the best substantive criteria has yet to be established.”

30. Even if a particular treatment could be decided on the basis of these clinical facts, judgment from practitioner to practitioner would still vary.

31. See Susan B. Rubin, “If We Think It's Futile, Can't We Just Say No?” HEC Forum 19 (2007): 45-65; 46. “In fact, in my clinical practice, so-called futility cases are by far the most common issue about which I am called to consult.”

32. Sharon H. Imbus and Bruce E. Zawacki, “Autonomy for burned patients when survival is unprecedented,” New England Journal of Medicine 297 (1977): 308-311.

33. Physicians would engage surrogates with a series of questions such as: “What kind of person was your loved one? What was important to him? Has he ever had a health crisis before? Did he ever see a television program or read a novel where these issues came up?” With these questions in mind, the physician could then ask what the surrogate thinks the patient would want and why.

34. For example, if a patient or surrogate persists that “everything should be done” and the physician disagrees out of a sense of harm or increased suffering to the patient, Rubin proposes that the physician should “dig deeper” by asking questions such as: “What does it mean to ask that ‘everything should be done'? Do you think that physicians should provide treatments that the doctors thought wasn't helping or was causing harm or was burdensome? Do you think by this he meant that he wanted physicians to do everything to make him comfortable?”

35. “If We Think It's Futile, Can't We Just Say No?” 50.

36. Case taken from John J. Paris, et al ., “Beyond Autonomy—Physicians' Refusal to Use Life-Prolonging Extracorporeal Membrane Oxygenation,” New England Journal of Medicine 329 (1993): 354-357.


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