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
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:
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:
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?
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
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.
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.
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.”
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.”
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.”
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?”