INTRODUCTION
This chapter treats the first topic relevant to any ethical problem in clinical medicine, namely, the indications for or against medical intervention. In most cases, treatment decisions that are based on medical indications are straightforward and present no obvious ethical problems.
EXAMPLE. A patient complains of frequent urination accompanied by a burning sensation. The physician suspects a urinary tract infection, obtains a confirmatory culture, and prescribes an antibiotic. The physician explains to the patient the nature of the condition and the reason for prescribing the medication. The patient obtains the prescription, takes the medication, and is cured of the infection.
This case exemplifies clinical ethics because it demonstrates the bioethical principles commonly considered necessary for ethical medical care, namely, respect for autonomy, beneficence, nonmaleficence, and justice. The symptoms are sufficiently clear for the physician to make a diagnosis and prescribe an effective therapy in order to benefit the patient. The patient’s preferences coincide with the physician’s recommendations. The patient’s quality of life, presently made unpleasant by the infection, is improved. Medications are available, insurance pays the bill, and no problems with family or hospital complicate the situation.
This case represents the ethical practice of medicine because each of the fundamental principles is fulfilled. It would become an ethical problem if one or more of these principles could not be fulfilled because several principles appeared to conflict or draw the decision in different directions. For example, if the patient stated that he did not believe in antibiotics, or if the urinary tract infection developed in the last phase of a terminal illness, or if the infection was associated with a sexually transmitted disease where sexual partners might be endangered, or if the indicated medication was in short supply and needed to be rationed. Sometimes, these problems can be readily resolved; at other times, they can become major obstacles in the management of the case.
In this chapter, we first define medical indications and explain the ethical principles most relevant to medical indications, namely, beneficence and nonmaleficence. We discuss the relationship of these principles to medical professionalism. We then pose a series of questions that link medical indications to the principles. In discussing these questions, we treat important features of clinical medicine related to medical indications, including the goals and benefits of medicine, clinical judgment and uncertainty, evidence-based medicine, and medical error. We offer typical cases to illustrate these discussions. We then consider three ethical issues in which medical indications are particularly prominent: (1) nonbeneficial (or futile) treatment, (2) cardiopulmonary resuscitation (CPR) and do-not-resuscitate (DNR) orders, and (3) the determination of death.
Medical indications are the facts and their interpretations about the patient’s physical and/or psychological condition that provide a reasonable basis for the physician’s clinical judgments aiming to realize the overall goals of medicine: prevention, cure, and care of illness and injury. Every discussion of an ethical problem in clinical medicine should begin with a statement of medical indications. In the usual clinical presentation, this review of indications for medical intervention leads to the determination of goals and the formulation of recommendations to the patient. Therefore, medical indications are those facts about the patient’s physiological or psychological condition that indicate which forms of diagnosis, therapy, or education are appropriate.
Responding to medical indications in the day-to-day work of clinical care for patients consists of: diagnosing their condition and providing helpful treatments. The ethical principles that govern these activities are the principles of beneficence and of nonmaleficence, that is, acting to benefit patients and not to harm them. The ancient moral maxim of medicine, stated in the Hippocratic oath, is “I will use treatment to benefit the sick according to my ability and judgment but never with a view to injury and wrongdoing.” Another Hippocratic imperative to physicians states, “be of benefit and do no harm” (Epidemics I). There are many ways to benefit persons, for example, by educating, hiring, and promoting an employee; giving a recommendation; or by making a gift. There are also many ways to harm persons, for example, by slandering, stealing, or assaulting. In medicine, benefit and harm have a specific meaning: helping by trying to relieve, as safely as possible, a person of the burden of disease and its attendant pain, distress, and loss of function.
Therefore, in medical ethics, beneficence primarily means the duty to try to bring about those improvements in physical or psychological health that medicine can achieve. These objective effects of diagnostic and therapeutic actions are, for example, diagnosing and curing an infection, treating cancer that leads to remission, facilitating the healing of a fracture, palliating pain, etc. Nonmaleficence means going about these activities in ways that prevent further injury or reduce its risk. So, this topic will treat medical benefits as objective contributions to the health of a patient. The subjective aspect of a patient’s choices, that is, their estimate of the value and utility that these medical contributions bring to them personally, and their acceptance or rejection of them, are discussed under Topics Two and Three.
In medicine, beneficence and nonmaleficence are assessed in what is called “benefit-risk ratio” reasoning. It would be clearly wrong for a physician to set out to harm a patient, but it is almost inevitable that when a physician attempts to benefit a patient, by medication or surgery, for example, that some harm or risk of harm is possible or may ensue. Surgical procedures cause wounds; most drugs have risks. Therefore, the principles of beneficence and nonmaleficence do not merely instruct the clinician to help and do no harm; they coalesce to guide the clinician’s assessment of how much risk is justified by the intended benefit. A physician must calculate this “ratio” and fashion it into a recommendation to the patient who will, in the last analysis, evaluate it in light of his or her own values.
EXAMPLES. (1) A patient with asthma and diabetes needs a course of steroids for worsening asthma but the doctor knows that steroids will make diabetes control more difficult. (2) An orthopedic surgeon recommends a total hip replacement for a patient who has severe pain and difficulty walking from a “bone-on-bone” degenerative hip problem. The surgery will require brief hospitalization, anesthesia, time away from work, and several weeks of recovery.
The competence of a physician to benefit the patient by his or her medical knowledge, skill and compassion, as well as the expectation and desire of the patient to be benefited by this competence are the key components of a therapeutic relationship. The principles of beneficence and nonmaleficence are the central ethical aspects of this relationship. This therapeutic relationship lies at the heart of medical professionalism.
The idea of professionalism once referred to a style of respectability, courtesy toward colleagues, and honesty with patients. Today, professionalism comprises much more: it centers on the patient-physician relationship. The Charter on Medical Professionalism states that professionalism “demands placing the interest of patients above those of the physician, setting and maintaining standards of competence and integrity, and providing expert advice to society on matters of health.” Professionalism encourages placing care for the patient ahead of the business of medicine. This implies that physicians should primarily pursue the goals of medicine in their dealings with patients, rather than pursuing personal, private goals. More directly, physicians must avoid exploitation of patients for their own profit or reputation. The benefits of medicine are optimal when physicians and other health professionals demonstrate a professionalism that includes honesty and integrity, respect for patients, a commitment to patients’ welfare, a compassionate regard for patients, and a dedication to maintaining competency in knowledge and technical skills. In manifesting these virtues, professionalism and ethics are linked. The ethical and professional responsibilities of physicians are closely tied to their ability to fulfill the goals of medicine in conjunction with their respect for patients’ preferences about the goals of their lives.
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The general principles of beneficence and nonmaleficence must be situated in the clinical circumstances of the patient. Thus, in dealing with an ethical problem in clinical medicine, we propose that clinicians first consider the topic of medical indications. We ask five questions that define the scope of the topic of Medical Indications. These questions form the structure of this chapter. In answering them, we will demonstrate how the clinical circumstances are linked to the bioethical principles of beneficence and nonmaleficence. These five questions are as follows:
What is the patient’s medical problem? Is the problem acute? chronic? critical? reversible? emergency? terminal?
What are the goals of treatment?
In what circumstances are medical treatments not indicated?
What are the probabilities of success of various treatment options?
In sum, how can the patient be benefited by medical and nursing care, and how can harm be avoided?
1.0.6 Question One—What Is the Patient’s Medical Problem? Is the Problem Acute? Chronic? Critical? Reversible? Emergency? Terminal?
Clinical medicine is not abstract; it deals with particular patients who present with particular health problems. Therefore, clinical ethics must begin with as clear and detailed a picture as possible of those problems. This picture is usually obtained through the standard methods of clinical medicine: the history, physical diagnosis, and data from laboratory studies, interpreted against a background of clinical experience. This leads to a differential diagnosis, as well as a management plan for further diagnostic tests and for treatment. As clinicians synthesize and organize the patient’s case, they consider the issues discussed below in Question 2.
1.0.7 Distinctions Regarding Diagnosis and Treatment: Is the Problem Acute? Chronic? Critical? Reversible? Emergency? Terminal?
Any differential diagnosis or treatment option will implicitly answer these five questions. However, it is important to raise them explicitly at the time of an ethics discussion or consultation. The ethical implications of particular choices are often significantly influenced by the answer to these questions. Some persons involved in an ethics discussion, such as the patient or a family member, may not understand these important features of medical reasoning. It is necessary to be clear about whether the ethical problem pertains, for example, to an acute reversible condition in a previously health person, or in a patient who has a terminal disease (such as pneumonia in a patient with widely metastatic cancer) or to an acute episode of a chronic condition (such as ketoacidosis in a diabetic patient). Therefore, the following points must be clear to all participants in an ethics discussion:
The disease. A disease may be acute (rapid onset and short course) or chronic (persistent and progressive). It can be an emergency (causing immediate disability unless treated) or a nonemergency (slowly progressive). Finally, a disease can be curable (the primary cause is known and treatable by definitive therapy) or incurable.
The treatment. Proposed treatments depend on the particular disease being treated. Patients’ decisions about treatment will vary based on their goals, desires, and values. A medical intervention may be burdensome (known to cause serious adverse effects) or nonburdensome (unlikely to have serious side effects). The potential burdens of an intervention are considered by patients and physicians when deciding on a treatment plan. In addition, interventions may be curative, offering definitive correction of a condition, or supportive, offering relief of symptoms and slowing the progression of diseases that are currently incurable. For certain progressive diseases like diabetes, supportive intervention, such as tight glycemic control, can be very efficacious, stopping or reversing disease progression and allowing the patient to maintain a high quality of life for many years. For other conditions, such as Alzheimer or amyotrophic lateral sclerosis (Lou Gehrig disease) treatments rarely delay the progression of disease, but may palliate symptoms and successfully treat acute episodes.
Four typical patients will reappear throughout this book as our major examples. The patients in these cases are given the names Mr. Cure, Ms. Cope, Mr. Care, and Ms. Comfort. These pseudonyms are chosen to suggest prominent features of their medical condition. Mr. Cure suffers from bacterial meningitis, a serious but curable acute condition. Ms. Cope has a chronic condition, insulin-dependent diabetes that requires continual medical treatment but also requires the patient’s active involvement in her own care. Mr. Care has multiple sclerosis (MS), a disease that cannot now be cured but whose inexorable deterioration can sometimes be delayed by treatments and always can be supported by good medical care. Ms. Comfort has breast cancer that has metastasized, for which there is a low probability of cure even under a regimen of intensive intervention.
CASE I. Mr. Cure, a 24-year-old graduate student, has been brought to the emergency room by a friend. Previously in good health, he is complaining of a severe headache and stiff neck. Physical examination shows a somnolent patient without focal neurologic signs but with a temperature of 39.5°C and nuchal rigidity. An examination of spinal fluid reveals cloudy fluid with a white count of 2000; a Gram stain of the fluid shows many gram-positive diplococci. A diagnosis of bacterial meningitis is made; administration of antibiotics is recommended.
COMMENT. In this case, the medical indications arise from the clinical data that suggest a diagnosis of bacterial meningitis for which a specific therapy, namely, administration of antibiotics, is appropriate. Nothing yet suggests that this case poses any ethical problem. However, in Topic Two, we shall see how ethical problems can emerge from what appears to be a noncontroversial clinical situation: Mr. Cure will refuse therapy. That refusal will cause consternation among the physicians and the nurses caring for him; it will also raise an ethical conflict between the duty of physicians to benefit the patient versus the duty to respect the autonomy of the patient. When that problem appears, clinicians may be tempted to leap directly to the ethical problems of the patient’s refusal. We suggest that the first step in ethical analysis should not be such a leap but rather a clear exposition of the medical indications. Analysis should begin with answers to the questions, “What is the diagnosis?” “What are the medical indications for treatment?” “What are the probabilities of success?” “What are the consequences of failure to treat?” and “Are there any reasonable alternatives for treating this clinical problem?”
CASE II. Ms. Cope is a 42-year-old woman whose insulin-dependent diabetes was diagnosed at age 18. Despite good compliance with an insulin and dietary regimen, she experienced frequent episodes of ketoacidosis and hypoglycemia, which necessitated repeated hospitalizations and emergency room care. For the last few years, her diabetes has been controlled with an implanted insulin pump. Twenty-four years after the onset of diabetes, she has no functional impairment from her disease. However, fundoscopic examination reveals a moderate number of microaneurysms, and urinalysis shows increased microalbuminuria.
CASE III. Mr. Care, a 55-year-old man, was diagnosed with multiple sclerosis (MS) 15 years ago. For the past 12 years, he has experienced progressive deterioration and has not responded to the medications currently approved to delay MS progression. He is now confined to a wheelchair and for two years has required an indwelling Foley catheter because of an atonic bladder. In the last year, he has become profoundly depressed, is uncommunicative even with close family, and rarely rises from bed. He has seen a psychiatrist on several occasions, who prescribed antidepressants, but Mr. Care does not take the medications consistently. His primary care physician suggests that that palliative care is indicated.
CASE IV. Ms. Comfort is a 58-year-old woman with metastatic breast cancer. Three years ago, she underwent a mastectomy with reconstruction. Dissected nodes revealed infiltrative disease. She received several courses of chemotherapy and radiation.
COMMENT. In these four cases, we present a very simplified picture of patients seen in terms of medical indications, that is, diagnosis and treatment. No specific ethical problems are described. As the book advances, various problems will arise that merit the name clinical ethical problems. Some of these are related to changes in medical indications themselves; some are due to the patients preferences, the patient’s quality of life, and the context of care. Topics Two, Three, and Four treat these questions. Mr. Cure, Ms. Cope, Mr. Care, and Ms Comfort will appear frequently in the coming pages. Details of these cases will occasionally be changed to illustrate various points as the text proceeds. In addition to these four model cases, many other case examples will appear in which the patients will be designated by initials.
The first question of Topic One, which examines the patient’s immediate presenting problems, as well as the patient’s overall clinical condition, is centrally important in developing both a clinical and an ethical analysis of the situation. This information is usually found in the patient’s chart. We emphasize that any clinical assessment or any ethics consultation must begin with a complete review of this information. We also emphasize that in some cases, an ethics consultation by a clinically knowledgeable ethicist might reveal that some important clinical information is missing and that clinicians should be encouraged to obtain it to make the ethical analysis more relevant and helpful.
In order to understand the ethical issues in a case, it is necessary to consider not only the nature of the disease and the treatment proposed but also the goals of intervention. The analysis and resolution of an ethical issue often depend on a clear perception of goals. The general goals of medicine are as follows:
Cure of disease
Maintenance or improvement of quality of life through relief of symptoms, pain, and suffering
Promotion of health and prevention of disease
Prevention of untimely death
Improvement of functional status or maintenance of compromised status
Education and counseling of patients regarding their condition and prognosis
Avoidance of harm to the patient in the course of care
Providing relief and support near time of death
In every particular case, these general goals are made specific by understanding the nature of the disease(s) involved in the case and the range of available, appropriate treatment. Therefore, attention must be paid to the distinctions stated above (see Section 1.0.7), as specific to the patient’s disease and to the particular circumstances of the patient.
In many cases, most of the general goals of medicine can be achieved simultaneously. For example, in the case of Mr. Cure and his bacterial meningitis, a course of antibiotics should cure the disease, relieve the symptoms, such as headache and fever, protect his nervous system from damage, and restore his health. However, at times, goals will conflict. For example, when considering the use of antihypertensive drugs in an asymptomatic patient, the goal of reducing risk of heart attack and stroke may conflict with the goal of avoiding harmful side effects, such as impotence and fatigue, that will impair a patient’s quality of life. In other cases, goals such as curing disease may be impossible to achieve because of a patient’s advanced condition and/or limitations in scientific and medical knowledge. In every medical case, the goals must be clear and conflicts among goals understood and managed, as far as possible.
An old medical maxim sums up the goals of medicine concisely: “Cure sometimes, relieve often, comfort always.” While the old maxim remains true, modern medicine has changed its application. Cure is much more often achieved than in the past: developments in anesthesia and asepsis have expanded surgical possibilities, and the development of modern pharmacology has expanded effective medical treatments. Many chronic diseases that were once lethal can now be effectively managed. In recent years, the medical profession has taken more seriously the mandate to “comfort always” and has improved its ability to provide palliation to chronically and terminally ill patients.
An ethical problem may appear in a case if the goals of intervention are poorly defined, are unclear or confused, or must be revised by the changing course of the disease. Goals that are perfectly reasonable when a patient is admitted for surgery may no longer be reasonable when, postoperatively, the patient has a cardiac arrest and anoxic brain damage. Sometimes, the ethical problem merely reflects a failure to clarify for all participants the feasible goals that the physician has identified; at other times, there may be a genuine conflict between goals. Clinical ethics consultation may assist clinicians to clarify when cure is possible, how long intensive medical interventions should be continued, and when comfort should become the primary mode of care. See Section 3.4.
In every case, patients and physicians should clarify the goals of intervention when deciding on a course of treatment. This clarification entails, first of all, the physician’s knowledge and skill in diagnosis and treatment: he or she must, to the extent possible in a given clinical setting, set and reset goals realistically. In addition, as we explain in Topic Two, the preferences of the patient must be considered even in setting medical goals.
1.1 INDICATED AND NONINDICATED INTERVENTIONS
One of the major sources of ethical problems is the determination whether a particular intervention is, or is not, indicated. Innumerable interventions are available to modern medicine, from counseling to drugs to surgery. In any particular clinical case, only certain of these available interventions are indicated, that is, clearly related to the clinical situation and to the goals of medicine. The competent clinician always judges what intervention is indicated for the case at hand. Thus, the term “medically indicated” describes what a sound clinical judgment determines to be physiologically and medically appropriate in the circumstances of a particular case.
Interventions are indicated, then, when the patient’s impaired physical or mental condition may be improved by their application. Interventions may be nonindicated for a variety of reasons. First, the intervention may have no scientifically demonstrated effect on the disease to be treated and yet be erroneously selected by the clinician or desired by the patient. An example of such an intervention would be high-dose chemotherapy followed by bone marrow transplantation for widely metastatic breast cancer or the use of estrogens for a postmenopausal woman in the mistaken belief that it will decrease the risk of coronary artery disease. These treatments are nonindicated. Second, an intervention known to be efficacious in general may not have the usual effect in some patients because of individual differences in constitution or in the disease. An example of this type of intervention would be a patient who takes a cholesterol-lowering statin drug and subsequently experiences an acute myopathy, a rare but known serious complication. Statins are not indicated for this patient. Third, an intervention appropriate at one time in the patient’s course may cease to be appropriate at a later time. An example of this would be ventilatory support, indicated when a patient is admitted to the hospital after cardiac arrest but no longer indicated when the patient is determined to have profound anoxic brain damage and/or multisystem organ failure.
Cases in which the usual goals of restoration of health and function seem unobtainable present themselves in several ways: the dying patient, the terminal patient, and the patient with progressive, lethal disease. We illustrate these three conditions by following the case of Mr. Care.
CASE. Mr. Care, a 55-year-old married man with two adult children, was diagnosed as having multiple sclerosis (MS) 15 years ago. During the past 12 years, the patient has experienced progressive deterioration and has not responded to the drugs currently approved to delay progression of MS. He is now confined to bed and wheelchair and for the last two years has required an indwelling Foley catheter because of an atonic bladder. He is now blind in one eye, with markedly decreased vision in the other. He has been hospitalized several times due to pyelonephritis and urosepsis. In the course of the last year, he has become profoundly depressed, is uncommunicative even with close family, and refuses to leave his bed. During the entire course of his illness, he has refused to discuss the issue of terminal care, saying he found such discussions depressing and discouraging.
Decisions about what treatment is indicated for Mr. Care are influenced by whether he is viewed as a dying patient, a terminally ill patient, or as an incurable patient. These three terms are explained in the following paragraphs.
Many interventions become nonindicated when the patient is about to die. In this section, we use the word dying to describe clinical conditions which indicate definitively that the patient’s organ systems are disintegrating rapidly and irreversibly. Death can be expected within hours. This condition is sometimes described as “actively dying” or “imminently dying.” In this situation, indications for medical intervention change significantly. We return to the case of Mr. Care.
CASE. Mr. Care is in the advanced stages of MS. During the past month, the patient has been admitted three times to the intensive care unit (ICU) with aspiration pneumonia and has required mechanical ventilation. He is admitted again, requiring ventilation and, after four days, becomes septic. On the next day, he is noted to have increasingly stiff lungs and poor oxygenation. In several hours, his blood pressure is 60/40 mm Hg and decreasing. He is unresponsive to pressors and volume expanders. His arterial oxygen saturation is 45%. He is anuric, his creatinine is 5.5 mg/dL and rising, and his arterial pH is 6.92. A house officer asks whether ventilation and pressors should be discontinued “because their use would be futile.”
COMMENT. Mr. Care has multisystem organ failure and is dying. Medical intervention at this point is often called futile, that is, offering no therapeutic benefit to the patient. Judgments about futility are often very controversial, and its meaning will be fully discussed in Section 1.2.2. At this point in Mr. Care’s case, the houseofficer uses the word futile in a quite obvious, noncontroversial way: as a shorthand description of a condition in which physiological systems have deteriorated so drastically that no known medical intervention can reverse the decline. The judgment of futility in this case approaches certainty. Some commentators use the phrase physiological futility for this situation, and some believe that it is the only situation in which the word futility should be applied.
RECOMMENDATION. Mr. Care is dying. His death will take place within hours. Ventilation and vasopressors are no longer indicated, because they are now having no positive physiological effect. Physiologic futility is an ethical justification for the physician to recommend withdrawing all interventions, with the exception of those that may provide comfort. If the patient’s family requests continued interventions, see the discussion in Section 1.2.2.
Judgments about whether certain interventions are indicated must be reevaluated when a patient is in a terminal condition. There is no standard clinical definition of terminal. The word is often loosely used to refer to the prognosis of any patient with a lethal disease. Under Medicare and Medicaid eligibility rules for reimbursement of hospice care, terminal is defined as a prognosis of six months or less to live. This is an administrative rather than a clinical definition. In clinical medicine, terminal should be applied only to those patients whom experienced clinicians expect will die from a lethal, progressive disease, despite appropriate treatment, in a relatively short period, measured in days, weeks, or several months at most. Diagnosis of a terminal condition should be based on medical evidence and clinical judgment that the condition is progressive, irreversible, and lethal. The benefits of accurate prognostication include informing patients and families about the situation, allowing them to plan their remaining time and arrange appropriate forms of care. However, such prognostication must be made with great caution. More than a few studies have shown that even experienced clinicians often fail to make accurate prognoses. Some physicians are overly pessimistic, but one major study shows that even more clinicians are inappropriately optimistic and fail to inform patients and, if appropriate, their families of the imminence of death.
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