Medical Futility

When can a medical treatment be considered medically futile, and what are the implications of determining that a treatment is futile? In certain instances, medical therapies that are efficacious are not beneficial. Although this occasional discrepancy between efficacy and benefit has long been recognized, it has been rediscovered by physicians and patients using medical technology of increasing complexity. New medical technology has made curable diseases that were once hopeless. However, the indiscriminate use of new technology has alienated patients, who fear being kept alive in the condition of vegetables, and physicians, who resent being viewed as technicians pushing buttons on ventilators. The problem is in defining which medical therapies fail to provide benefit in specific clinical contexts. Such therapies are often described as medically futile.

A widely accepted, practical definition of medical futility does not yet exist (Youngner, 1988). In the bioethics literature, futility has been used to describe situations in which a medical therapy has an extremely low chance of providing (1) some physiologic effect (Lantos et al., 1989; Youngner, 1988), (2) prolongation of life, (3) a minimal quality of life (Schneiderman, Jecker, & Jonsen, 1990), or (4) a goal pursued by the patient (Lantos, Miles, Silverstein, & Stocking, 1988). Some definitions of medical futility require agreement by physician and patient; some definitions do not require that the physician even discuss the therapy with the patient. Perhaps the most influential definition of medical futility has been proposed by Schneiderman et al. (1990), because it lays out clinically useful guidelines for determining when a medical therapy fails to provide benefit.

The Schneiderman definition of futility specifies independent quantitative and qualitative criteria. If an intervention is expected to have less than a 1% chance of patient benefit, which must be distinguished from a strictly physiologic effect, the intervention should be considered medically futile. In Alan's case, palliative radiotherapy for brain metastases would not be futile by the quantitative Schnei-derman criterion. Alternatively, if an intervention is expected to result in an unacceptable quality of life, the intervention should also be considered medically futile. Because many patients would consider life during and after brain radiotherapy to be acceptable, the qualitative Schneiderman criterion for medically futile intervention also does not cover Alan's radiotherapy.

The significance of judging an intervention to be medically futile is that physicians are no longer obliged to offer that intervention. Schneiderman notes that medical futility determinations are specific to particular therapies and would not apply broadly to medical care. Once an intervention has been determined futile for a particular patient, the physician would not be obliged to consider it further, although the physician has a responsibility to explain to the patient and family why the intervention is futile. Thus futility determinations raise issues of accuracy, accountability, physician respect for patients, and information disclosure, which perhaps explains why some ethicists and physicians remain skeptical that medical futility will help limit medical care appropriately.

The Schneiderman definition of medical futility has been widely debated, and several objections have been raised (D. Callahan, 1991b; Honegger, 1991; Lan-tos et al., 1989; Truog, Brett, & Frader, 1992; Youngner, 1990). The 1% quantitative standard has been criticized as lacking consensus from the medical community and as clinically inappropriate. Outcome data are not available for many situations in which physicians raise questions of futility, although the quantitative standard lays out a framework for future outcome studies. The qualitative standard is problematic because patients and physicians disagree about how an ''unacceptable'' quality of life can be defined. Most seriously, critics of the Schneiderman definition object to the withholding of futile treatments as paternalistic and inimical to shared decision making. These critics foresee a potential problem in physicians making unilateral, value-laden decisions, such as the decision made by Alan's physician. One study describing how futility is used in establishing do-not-attempt-resuscitation orders showed that medical residents sometimes make futility determinations inappropriately (Curtis, Park, Krone, & Pearlman, 1995). For instance, qualitative futility was determined without discussing quality of life with communicative patients in one-third of the cases where this type of futility was the basis for an order to withhold cardiopulmonary resuscitation.

In the case here, Alan's physician uses futility in a casual sense that fails to engage the ethical implications of futility determinations. Rather than entering into a discussion about medical futility, Alan and his physician ought to discuss the risks and benefits of radiotherapy for brain metastases. Although Alan's lung cancer is incurable, radiotherapy confers some palliative benefits in both survival and control of symptoms such as confusion. Although some patients in Alan's situation might decide to forgo radiotherapy, that decision ought to rest on medical information about the outcomes of radiotherapy and Alan's personal values and goals.

Futility determinations are often viewed as a conflict between medical authority and patient autonomy. However, discussions about interventions that may be medically futile can often be reframed within an ethic of care. As described by Schneiderman, Faber-Langendoen, and Jecker (1994), an ethic of care would stress end-of-life care designed to emphasize comfort, dignity, and nonabandon-ment rather than the application of lifesaving treatments. This ethic of care differs from beneficence in stressing a process of care, rather than a treatment outcome, that is based on an ongoing relationship with a medical care provider. Reframing goals of care in this way might allow Alan and his family to separate further intervention from further care and allow Alan to think more clearly about what he would want near the end of his life.

Complementary Medical Therapies

What is the physician's responsibility to a patient who uses alternative or complementary therapies? Only recently have physicians realized how frequently patients use alternative medical therapy (Eisenberg et al., 1993). In one study, almost 50% of cancer patients sought complementary therapy at some point during their illness (Cassileth & Berlyne, 1989; Cassileth, Lusk, Strouse, & Bodenheimer, 1984). The actual practices range from discussion groups to injections of serum to coffee enemas. The reasons that patients pursue these alternatives to allopathic medicine include a distrust of biomedical science, a need for caring that these patients often fail to find from traditionally trained physicians, and a need to believe that a nontoxic cure of a life-threatening illness is possible. Complementary therapies are most prominent when traditional medical treatments, often described as allopathic, are toxic or have limited efficacy.

Ironically, the major difficulty that physicians have in dealing with alternative treatments is the lack of efficacy data. The Office of Technology Assessment (1990) after an extensive review of alternative cancer treatments concluded that most have little scientific data to recommend them. For instance, most alternative practitioners base their claims on anecdotal cases that do not have a diagnosis of cancer established by a biopsy. The patients are not followed systematically. The causes of death, when noted, are not established. This absence of evaluable data is the major reason that complementary therapies have not earned the respect of the medical establishment (McGinnis, 1991).

The sole complementary therapy that is backed by scientific data is the use of discussion groups for metastatic breast cancer (Spiegel, Bloom, Kraemer, & Gottheil, 1989). Spiegel and colleagues demonstrated that survival appeared to be prolonged in patients randomly assigned to peer discussion groups facilitated by a psychiatrist; the paper generated much interest, but these findings have not yet been replicated. While this example is often cited as a foothold for complementary therapies amid the usual allopathic armamentarium, it scarcely begins to address the issues that physicians face in dealing with complementary therapies.

The challenge for physicians is twofold: first, proponents of alternative therapy charge allopathic physicians with holding cultural biases derived from their professional training. For instance, alternative practitioners charge that allopathic physicians overemphasize physical aspects of health and devalue mental and spiritual aspects of health. A second challenge for allopathic physicians is that well-informed patients may prefer alternative forms of care. These challenges can be examined using approaches developed in the bioethics literature. With regard to allopathic biases, we will first examine how a physician's obligation to a patient depends on how both parties conceive the physician-patient relationship. Next, we will examine preferences for complementary therapy as one type of multicultural medical encounter, drawing on an ethical framework that has been proposed for evaluating professional responsibilities for providing care.

A physician's obligation to a patient who seeks complementary therapy depends on how both parties consider the physician-patient relationship. The four models of physician-patient relationships proposed by E. J. Emanuel and L. L. Emanuel (1992) highlight different levels and types of physician obligations.

In the Emanuels' paternalistic model, the physician assumes that the patient shares the same values as the physician and acts to promote the patient's well-being independent of the patient's current preferences. The paternalistic physician is, for purposes of health care, the patient's guardian. Although this physician would probably not have inquired about use of complementary therapy, he or she would be obliged to prevent or discourage the patient from using it. The problem with this approach is that it fails to adequately respect patient autonomy and may, paradoxically, encourage some patients to try complementary therapy.

In the informative model, the physician acts as a source of information and allows the patient to decide what treatments should be given. If a physician were approached by a patient with a request for complementary therapy, the physician would be obliged only to state what he or she knew about the efficacy of the complementary therapy. The physician would not be obliged to make a recommendation, nor would one be expected by the patient. This model fails to acknowledge two aspects of most physician-patient relationships. It assumes that patients have fixed and known values that allow them to make decisions about their treatment, but often patients are uncertain about what they want. A crucial role for the physician is in helping patients figure that out. In criticizing this model, the Emanuels stress the human capacity for ''second-order desires,'' or the capacity to reflect on one's wishes and even revise preferences. This is particularly important for patients with life-threatening illnesses, who often reorder their priorities in life. The other aspect of physician-patient relationships that this model fails to address is the importance of a process of care in discussing treatment alternatives.

In the interpretive model, the physician acknowledges that patient values can be inchoate and conflicting and that an important physician role is to help the patient sort things out. The physician's obligations are to inform the patient, as in the informative model, but further, to bring the patient to a level of self-understanding that will help him or her make good medical decisions. Thus, for a patient who inquires about complementary therapy, a physician would be obliged to help the patient determine why he or she is seeking it. For instance, is the patient seeking complementary therapy because he is depressed about his metastatic colon cancer? Perhaps acknowledgment and treatment of depression would be more useful for this patient than coffee enemas. The physician ought to probe more deeply to better understand the meaning of the patient's request. The major problem here is whether physicians are actually capable of doing this, and there seems a clear danger that physicians will use their own values in making such decisions, which undermines patient autonomy in a pernicious way.

The Emanuels' deliberative model includes the features of the interpretive model and adds a physician obligation to help the patient achieve a type of moral self-development by instructing the patient in good health-related values. In discussing complementary therapy, this model would oblige the physician to discuss the rational basis and scientific justification for medical therapy. This model embodies most of the features patients and physicians value in their relationships. The emphasis on physician values, in particular, makes explicit the basis for specific recommendations. There is no pretense that a scientific recommendation is value free. The problem with the deliberative model is its complexity. This model of physician-patient relationships goes far beyond rules of nonmaleficence, beneficence, and respect for patient autonomy (Beauchamp & Childress, 1994). The deliberative model appeals to a consideration of virtue. Virtue, as used in the context of the physician-patient relationship, would be based on an idealized physician who would act in a virtuous way. A focus on virtue-based ethics, as propounded by Alasdair MacIntyre (1981), would move beyond rules to considerations of an individual physician's integrity and character. However, virtue-based ethics tends to be short on explicit recommendations for paradigmatic cases.

A different approach for a physician asked to provide complementary therapy is to consider it a multicultural interaction. Not all Americans, for example, subscribe to allopathic beliefs about the role of technological interventions in healing. Bioethicists have documented distinct cultural differences in patient preferences for receiving bad news and for exercising personal autonomy. In one large study conducted in Los Angeles, Blackhall and colleagues demonstrated that Korean Americans reported a markedly lower desire to receive news of metastatic cancer, compared to Mexican Americans, black Americans, or European Americans (Blackhall, Murphy, Frank, Michel, & Azen, 1995). In an ethnographic study of Navajo Indians, Carrese and Rhodes (1995) demonstrated that advance care planning, for instance, would constitute a dangerous violation of traditional values. For a Chinese man to request acupuncture may represent simply a traditional ethnic belief rather than distrust of allopathic medicine or a particular physician provider.

A framework for using multicultural experiences as a perspective for an ethical analysis of physician interactions with complementary therapy has been described by Jecker, Carrese, and Pearlman (1995). They describe an approach to multicultural ethical problems that consists of three steps: identifying goals; identifying mutually agreeable strategies; and meeting ethical constraints. The process of identifying goals and strategies could serve as a safeguard for care-givers, requiring them to step back and ask what they are trying to achieve for patients with nonallopathic beliefs about medicine and healing. In caring for a patient like Alan, caregivers will rapidly progress to an examination of their own ethical constraints. At this level of analysis, a physician may refuse to supervise shark cartilage and justify refusal because the practice would violate professional integrity, which requires that the physician act in accordance with his or her own ethical convictions and beliefs. Ultimately, these authors recommend that differences be adjudicated through a procedure that begins with a nonjudgmental stance and that recognizes inequalities of power in the physician-patient relationship. The authors do not specify details of the adjudication procedure, but presumably all parties would be represented, including third-party payers. Further empirical work could define the nature of multicultural problems that patients and physicians encounter, as well as the effect of a process such as the one Jecker, Carrese, and Pearlman describe.

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