RETRACTED: Ethical issues in surgical treatment and research

Ethical Issues in Surgical Treatment and Research Informed Consent and Communication Between Surgeons and Patients

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If there is a single ethical concept that is more closely related to surgery than to any other aspect of medical care, informed consent would be a good candidate for that concept. All surgical procedures are predicated on the patient having made a decision about participation and giving the surgeon permission to operate. Even in emergencies when time does not permit informed consent (eg, a hypotensive patient with a gunshot wound to the abdomen), surgical intervention is undertaken on the basis of the concept of presumed consent. In those situations, most patients would want their physicians to provide lifesaving treatment unless the patient had made a specific countervailing request. Central to informed consent is the necessary transfer of information from physician to patient so that the patient can make a decision about the procedure. This transfer of information requires skill in assessing the capacity of the patient to make decisions, skill in communication, and an understanding of the complexities of truth-telling. All of these topics are relevant to the discussion of informed consent. Informed consent can be broadly divided into consent for treatment and consent for research. Informed consent for treatment is the common understanding of the patient giving permission for a specific therapeutic operation. Informed consent for treatment is a process that occurs between surgeon and patient independent from significant oversight and regulation. Despite the lack of regulatory oversight of informed consent for treatment, lapses in obtaining consent, at least in the United States, are subject to malpractice litigation. In contrast, informed consent for research is a closely regulated issue and is required before any patient can be enrolled in a research trial. Components of Informed Consent. For informed consent for treatment to be valid, patients must: (1) be provided sufficient information to make an informed decision; (2) be competent to give consent; (3) be aware of Curr Probl Surg 2003;40:345-448. 0011-3840/2003/$30.00 ⫹ 0 doi:10.1016/S0011-3840(03)00035-2

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the right to refuse treatment; and (4) voluntarily agree to the procedure.1-4 Patients must be given adequate information to understand the risks, benefits, and alternatives of the procedure being proposed. The surgeon must present this information to patients in ways that the patient can understand. This process of presenting information to the patient in order for the patient to be informed about the procedure is a private matter between the surgeon and the patient. There is no regulatory oversight that ensures that the surgeon has discussed the risks, benefits, and alternative treatments with patients. The individual surgeon must give only enough information to satisfy the specific patient. The amount of information that each patient wants will vary dramatically. Furthermore, in most hospitals, there is no specific requirement of what must be included in the informed consent document that the patient signs. As such, the informed consent form does not document the content of the information that was supposed to be transferred from the doctor to the patient. Instead, the signed informed consent form only signifies the patient’s willingness to go along with the recommendations that the physician has made. In the realm of consent for treatment, the informed consent document is merely a validation of the process that was supposed to have occurred between the physician and patient.5 Frequently, the form that is actually signed is a generic one that is used for any and all surgical procedures. In contrast to consent for therapy, when patients are asked to participate in a research study, the requirements for adequate informed consent are defined much more strictly. In the research arena, informed consent still involves a discussion of risks, benefits, and alternatives to the study, but since there can be no assumption that the patient will garner any benefit from participation in the study, more attention is directed to ensuring that the subject has actually been informed of specific issues. Informed consent for research involves communication between researcher and subject as does consent for treatment, but the requirement of a specific and detailed informed consent document for each study is an attempt to ensure that certain critical issues have been discussed with the subject. The informed consent form for research is a detailed document specifically written for a particular study. The mandatory content of the informed consent form is determined by federal regulations. Certain paragraphs must be included to address the risks to the subject of the study, the potential benefits of the study to the subject, and the voluntary nature of participation in the research. The subject must be informed of the alternatives to participation in the research and the opportunity to withdraw from the study at any time. Exactly how these and other issues are documented in the informed consent form is carefully reviewed by an 354

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Institutional Review Board for human subjects research before any subjects can be enrolled in a study. Consent and Physician-Patient Communication. Many physicians see the requirement for obtaining informed consent from patients to be a requirement that the patient has heard the important risks, benefits, and alternatives of the proposed procedure. Such an understanding of the doctrine of informed consent, however, can lead to potential conflicts between patients and their physicians when the patient requests the physician not to disclose certain information. This is a sensitive topic for many surgeons who see their moral responsibility as fully explaining a procedure so that the patient can decide whether to agree to the procedure. If, for example, a woman who needs an elective colon resection stops the surgeon from explaining the potential risks of infection and anastamotic leak, how should the surgeon respond? Patients do not frequently request nondisclosure, but family members may make exactly that request. Consider a surgeon who completes an exploratory laparotomy and goes to the waiting room to discuss the operative findings with the patient’s family. If the family members request that the surgeon not tell the patient that the cancer was found to be unresectable, the surgeon should take the opportunity to explore why this request is being made. Often family members have not fully explored the ramifications of their request for nondisclosure. They may not understand how not addressing the results of the operation with the patient will deprive the patient of information that might be critical to decisions near the end of life. If the surgeon goes along with the request and does not discuss the findings with the patient, the patient is not being treated as an autonomous being. Only with accurate information can patients make autonomous choices about how they want to live their lives no matter how little time may be left to them. On the other hand, if the patient (not the family) has requested that information not be communicated, the situation is quite different. If a patient states that she does not want to hear about the risks of elective colon resection, the surgeon must be sure to explore why such a request is being made. If the patient persists in requesting that she not be told of the risks, the surgeon should go along with the request. Based on the doctrine of informed consent, patients can make a conscious decision not to hear about the risks, benefits, and alternatives to a procedure. If the patient waives the right to hear about such topics, then the surgeon should abide by the patient’s wishes. In other words, the requirement for consent for surgery does not require all patients to be informed of the risks, benefits, and alternatives to a particular procedure. Instead, the doctrine of Curr Probl Surg, July 2003

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informed consent requires that every patient who is to have surgery must be given the opportunity to be informed about the procedure. If a patient states that she does not want hear about the risks of the operation, then the surgeon should document that an effort was made to discuss risks with the patient, but the surgeon should not recite the risks against the patient’s wishes. In many teaching hospitals, surgical residents are frequently asked to obtain informed consent from patients undergoing elective surgical procedures. To do this, residents must have an in-depth understanding of the procedure for which they are obtaining informed consent so that they can appropriately characterize the risks, benefits, and alternatives. Several investigators have suggested that surgical residents often do not have the ability to proceed with an optimal consent process because of the time constraints in a busy academic hospital.2,6 Other investigators have found that surgical residents often have little understanding of the surgical procedures for which they are obtaining consent.7,8 Soin and colleagues found that junior surgical residents in Great Britain lacked sufficient knowledge of several common procedures to obtain consent properly for those procedures.9 Angelos and colleagues confirmed these findings in an American academic teaching hospital.10 These studies highlight the need to better educate surgical residents in the operative procedures in a way that prepares them to obtain meaningful consent. A strategy of reviewing risks, benefits, and alternatives of procedures with residents either formally or informally would likely improve their ability to obtain informed consent. Expectations of Confidentiality. Just as the principle of respect for autonomy is the basis for informed consent, it also provides the justification for maintaining the confidentiality of a patient’s information. Included in the ability to make choices about one’s life is the ability to make choices about how much information others have about oneself. Seigler has accurately shown that many health care professionals have a legitimate need to review private information in the medical record about patients.10 Nevertheless, it is important to reiterate the central role that the individual physician has in maintaining the privacy of the information that is obtained about patients. Patients expect that their physicians will not divulge information about them without their permission. Whenever the law limits the physician’s ability to maintain confidentiality (eg, communicable diseases, gunshot injuries, etc.), the physician must clearly explain to the patient that the information must be passed on to another party. 356

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Prospects for the Future. Given some of the valid concerns about the adequacy of the communication process in obtaining informed consent, one possible result is to look to technology to “fix” the problems with the informed consent process. For example, if the problem is that surgeons do not provide adequately detailed information about procedures to patients, one approach would be to specifically list the indications, risks, benefits, and alternatives to each treatment in the consent form. Such an approach would make the consent form for treatment a detailed document much more similar to the forms used in the research setting. The potential exists to have a database of such consent forms on a computer system so that the specific form could be obtained for each type of procedure. Certainly this approach would be an improvement over the generic consent form that most surgical patients currently sign. However, the mere existence of these detailed documents may have little impact in improving the communication between physician and patient. Although the potential benefits of improved technology remain unknown at this time, benefits to patients may be more likely if greater attention is directed toward improving the communication skills of surgeons. Conclusions. The informed consent process is a complex interaction between physician and patient (or investigator and subject) that demands a high degree of skill in communication. Patients must understand why they need an operation as well as the potential risks and alternatives to the procedure. Patients must also understand that they are free to make a choice about whether to accept or decline the procedure. For surgeons to improve the consent process, they must have an adequate understanding of the surgical procedures and skill in communicating that information to patients.

Ethics and End-of-Life Issues Clinical situations are complex because they often involve a multitude of medical facts and a spectrum of values. Often decisions must be reached quickly, and clinicians prefer concrete and direct guides to action. Jonsen and colleagues have identified 4 topics that can guide sound ethical judgment in clinical situations.11 These essential features are: (1) medical indications; (2) patient preferences; (3) quality of life; and (4) the contextual features surrounding the case such as socioeconomic, legal and administrative features. No case can be discussed adequately without reference to these topics. A clear view of the possible benefits of intervention is the first step in assessing the ethical aspects of a case. In every clinical case, questions must be raised such as: ‘What are the patient’s goals? What does the

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patient want? Does the patient have enough information? Does the patient comprehend? Is the patient consenting voluntarily? Has the patient been coerced? Who has the authority to decide?’ Although the object of all medical intervention is to restore, maintain, or improve the quality of life, every medical case is located in a larger context of person, institutions, and financial and social arrangements. Patient care is influenced, positively or negatively, by the possibilities and the constraints of that context. A clear understanding of a patient’s medical status (ie, the nature of the disease, its prognosis, and the available treatment) and, most of all, the goals of the intervention, are crucial to the understanding of any ethical problem that might arise in a case. The ethical responsibilities of physicians derive primarily from the physician’s ability to fulfill the goals of medicine in conjunction with the patient’s preference about the goals of life. The physician’s central responsibility is to use medical expertise to respond to the patient’s need for help. Often the ethical problem in a particular case will arise from a lack of clarity about the goals of intervention or from the apparent incompatibility between goals and decisions to forego ineffective or futile interventions. It is sometimes the case that medical intervention does not offer any benefit to the patient. Usually the judgment that intervention is ineffective or futile reflects greater or less probability. However, in some occasions treatment will certainly offer no benefit. One of those occasions is when the patient is dead; the benefits of all interventions to the patient cease. In less clear circumstances, a complex assessment is necessary. Many ethical and clinical problems are caused by public policies in the structure of institutions. For a variety of reasons, such as limited fiscal resources, political pressures, or legal provisions, decisions about patients may be constrained or limited such that the care of the patient is inhibited in ways that seem ethically inappropriate. Individual physicians and patients may feel that they are able to do little under these circumstances. As a result, they may be faced with undesirable options for ethical choice. In ethics and law, physicians have a fiduciary duty to their patients (ie, they are obliged to exercise special care to promote the interests of their patients). Many other parties may have some interest in that encounter and its outcome. Traditionally, families have such an interest. However, in modern medical care, many other parties claim interest in the care of patients: the hospital administrators, third party payers, employers, litigants, lawyers, and so forth. The legitimacy of these various claims is an ethical issue. The allegience physicians owe to their patients requires that physicians advocate their patient’s interests, such as access to the 358

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most appropriate care or the preservation of confidential information before the interest of parties outside of the primary relationship. As a general principle, it is to be proposed that contextual features should not be decisive over consideration of medical indication, patient preference, and quality of life. However, contextual features have become more decisive in clinical decisions when all of the following conditions are met: (1) to achieve a significant goal of medical intervention is doubtful, (2) the preferences of the patient are not and cannot be known, (3) the quality of the patient’s life is minimal or below minimal, and (4) the contextual feature in question is specific and notably burdensome to others and a decision will make the difference in alleviating the burden. Some of the practices that were controversial 5 years ago in the care of the dying patient have become accepted and routine.12 Do no resuscitate orders, nonexistent only a few years ago, are now commonplace. Many physicians and ethicists now agree that it is ethical to withdraw nutrition and hydration from certain dying, hopelessly ill, or permanently unconscious patients. The public and the courts have tended to accept this principle. Most important, there has been an increase in sensitivity to the desires of dying patients on the part of doctors, other health professionals, and the public. This increased awareness of the right-to-die has also been translated into new laws. Most states now have legislation covering advance directives and many also specifically provide that a patient’s health care spokesperson or proxy can authorize a withholding or withdrawal of life-support.13,14 Many patients are aware of their right to make decisions about their health care, including their refusal of lifesustaining measures. Yet few actually execute living wills or appoint surrogates through a health care proxy. Although such documents can be very helpful in clarifying the patient’s wishes, they are all too infrequently discussed near the end of life. Physicians have a responsibility to consider timely discussions with patients about life-sustaining treatments in terminal care. The best time to begin this discussion is during the course of routine nonemergency care, remembering that not all patients are prepared emotionally, by virtue of their stage in life, their psychological make-up, or the stage of their illness. Nonetheless, as a matter of routine, physicians should become acquainted with their patients’ personal values and wishes and should document them just as they would document information about medical history, family history, and social or cultural background. Such discussions and the resulting documentation should be considered a part of the minimal standard of acceptable care. The physician should take the initiative in obtaining the documentation and should enter it in the medical records. Curr Probl Surg, July 2003

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When the patient is irreversibly dying, the balance between minimizing pain and suffering and potentially hastening death should be struck clearly in favor of pain relief. Narcotics or other pain medication should be administered in whatever dose and by whatever route is necessary for relief. The proper dose of pain medication is a dose that is sufficient to relieve pain and suffering even to the point of unconsciousness. Dying patients often feel isolated and doubt that their physician will relieve their pain as they near death. Early in the course of fatal disease, patients should be offered strong reassurance that pain will be controlled and that their physician will be available when the need is greatest. Both the patient and family should be told that addiction need not be a source of concern and that the relief of pain would have nothing but a salutory effect from both the physician’s and the patient’s standpoint.

Common Problems with End-of-Life

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Communication of Information. Physicians may not provide patients with sufficient comprehensible information about the nature and significance of their problems, the potential courses of action, and the likely outcomes. This information gap may occur at any stage of an illness but occurs most frequently after treatment fails and it becomes more evident that the patient will not survive. It reflects the difficulty physicians have in recognizing when this point is reached and then telling patients about the advance of the disease and the probability of impending death. Too frequently information that should be shared first of all with the patient is given instead to the family. This creates a complex web of indirect communication that is at best unnecessary and at worst unkind and unethical. Unskilled attempts to inform patients have created a practice best described as the assault of truth. The nature of the illness and its likely outcome are conveyed in such a blunt, unkind way that patients feel and indeed are emotionally assaulted. This bluntness is mistakenly believed to be the best form of honesty. Of course, the physician then fails not only to communicate gently but also to outline a proposed plan of action in a positive way. This serves to induce helplessness, hopelessness, and despair in the patient and family. The patient who then tries to cope in a hopeful manner may be labeled as denying or having an inappropriate attitude and may then be retold the truth (by the physician).15 Withdrawal by the Physician. Subtle abandonment by the physician may occur through withdrawal from contact with the patient, by having the housestaff assume the care, or failure to communicate vital information and provide interpersonal support. It may include fewer visits and a failure to deal with sensitive emotional issues that are important to the 360

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patient. Physicians may withhold expressions of warmth and spontaneity or fail to acknowledge the bond of humanity that they share with the patient. Although a physician’s desire to withdraw may be a normal human response in the face of suffering and sadness, professional responsibility requires that it not occur.16 Patient Labeling. Patients may all too commonly be labeled as difficult, denying, manipulative, angry, or unintelligent. Such labels usually arise from isolated encounters. Labeling has several ill effects. It is unkind, in that it blames the patient and family whereas the problem may belong more with the system or a particular situation within it. In addition, intolerance is labeling’s companion. Dying is a highly personal event. Because the goal of any intervention is to benefit and support the patient and the family, one must be extremely careful not to reject their long held beliefs, values, cultural mores and practices, and patterns of living. A focus on the patient’s best interests and wishes will help prevent the imposition of the health professional’s values. Societal norms and professional codes of ethics will provide the framework by which to gauge the moral acceptability of various patterns of practice by patients, families, and professional colleagues. Poor Health Care. The term cacothenasia has been used to describe an ugly or violent death17 that may be because of undertreatment, inadequate symptom control, poor physical care, and abandonment of the patient. It may also apply to over-treatment of the wrong type such as continued aggressive, cure-oriented treatment of patients who would choose palliation or a cessation of treatment if they had sufficient information. The drab and featureless institutions in which many people still die contribute to another form of cacothenasia, which is even less acceptable when we know that we could do better.

Decisions Near the End of Life Decisions near the end of life have a clinical and psychological intensity that distinguishes them from more routine clinical decisions. Patients who have decision-making capacity and who are adequately informed of their clinical situation and options have the right to refuse any recommended medical treatment, including life-sustaining treatment, except in rare circumstances in which the law forces the patient to accept treatment. The crux of the issue is that the patient’s rather than the physician’s assessment of the benefits and burdens of treatment should determine what treatment is administered or withheld. Many patients, particularly those with terminal or irreversible illness, elect to forego life-sustaining treatments. In some cases, physicians may consider that such refusals of

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treatment are unwise. Physicians have an obligation to ensure that the refusal is truly informed, to give clear recommendations, and to try to persuade the patient, but ultimately they must accept the patient’s decision. When patients lack decision-making capacity, decisions regarding life-sustaining treatment may be complicated for several reasons. Standards for assessing decision capacity may be unclear; the criteria for making decisions for such patients may be controversial; and disagreement may occur about who is the appropriate surrogate decision-maker.18 In order of priority, decisions for patients unable to make their own choices should be based on advance directives, substituted judgments, and the best interests of the patients. Patients’ informed goals and choices should be respected even if they no longer have decision-making capacity. Through advance directives, competent patients state what treatments they would accept or decline if they lost their decision-making capacity. In giving advance directives, patients should also indicate their general goals for care and their choice of surrogate. Oral statements to family members, friends, and health care professionals are the most common forms of advance directives. However, oral statements are problematic if they are vague and ambiguous or if they were casual comments rather than seriously intended directives. Because some states regard oral advance directives as untrustworthy, written advance directives have several advantages. A person who is authorized to make a decision on behalf of the person who is incapacitated is called a surrogate or a proxy. Two standards have been developed for surrogate decision-making in cases in which the patient has not left an advanced directive. In a substituted judgment, the surrogate attempts to make the judgment that the patient, if competent, would have made. This approach is feasible and desirable when the surrogate knows the patient’s goals, values, and choices. If the patient’s values and preferences are unknown or unclear, decisions should be based on the patient’s best interests. In recent years, many states have enacted legislation that gives specific authority to family members and ranks them in priority. The durable power of attorney statutes also provide for a surrogate who may supercede family members. Finally, all states have provision for the appointment of guardians or conservators for those individuals who are declared legally incompetent. If the patient’s own preferences are unknown or unclear, the proxy must promote the best welfare of the individual. Welfare is defined as those choices about relief of suffering, preservation or restoration of function, and extent and quality of life sustained that reasonable individuals in similar circumstances would be likely to choose. 362

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Autonomy of Refusal

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The Right to Forego. The modern recognition of the right to stop life-sustaining care began in 1976 with the United States case of Karen Ann Quinlan, who was in a persistent vegetative state (a state of permanent loss of higher cortical activity but with some maintenance of brainstem function). The New Jersey Supreme Court determined that she “had a constitutional right to privacy to forego treatment, given a poor quality of life, which could be exercised on her behalf by her parents.” Since then, courts and jurisdictions across North America have recognized a broad right of competent patients to refuse treatment.19 The limiting of life support and care is now a common event. Any kind of care, be it feeding or artificial breathing, be it ordinary or extraordinary, may be stopped or withheld.20 Stopping dialysis, for example, is the second leading cause of death in patients who have kidney failure in Canada and the third leading cause of death for those patients in the United States. As of 1988, this accounted for 8% to 15% of deaths for dialysis patients.21 With proper attention to palliative care, stopping life-sustaining care can result in “good” deaths.22 Physicians have a large discretionary role to play in end-of-life decisions. Their decisions, however, do not always agree with those of patients or surrogates.23 Although it might be hoped that unilateral decisions by physicians are based on objective factors such as the presence of other disease, such may not be the case.24 There is a wide variation in end-of-life decisions by physicians in different countries.25 Even in a single country such as Canada, a significant proportion of health care professionals would treat similar patients in totally different ways.26 Variability in ethical decisions should not be surprising because most of medical care exhibits a great regional variation. Part of the answer to such clinical variation must be to involve patients and their surrogates or families in end-of-life decisions. Otherwise, these critical decisions may be based on less than impartial factors and so be less than most appropriate ethically. To reduce the variability in decisions, health care professionals should also consider the factors that may lead to inappropriate requests to end treatment. Reasons Patients Refuse Treatment. The refusal of treatment may be precipitated by problems in the patient/physician relationship, such as poor communication.27 Several factors affecting refusal of treatment that must be addressed before limiting treatment include a poor doctor/patient relationship, poor communication, negative feelings among staff toward the patient, difficult family relationships, impairment by drugs and Curr Probl Surg, July 2003

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TABLE 1. Approach for stopping life-sustaining treatment Firmly establish a diagnosis. Ensure that all reasonable options have been resolved. Make sure you know why the patient wants treatment stopped. Ensure the patient is as physically comfortable as possible. Ensure the patient is mentally capable or has a surrogate. Ensure the patient understands the illness, the options, and the consequences. Ensure the patient’s choice is not unduly influenced by others. Discuss over time the patient’s wish for foregoing care. Involve the patient’s significant others if he or she wishes. Involve consultations with specialists as appropriate. Ensure that final decisions are made openly with the patient and significant others and with the treatment team. (12) Ensure the decisions are defensible and reasonable.

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(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

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alcohol, less than maximal quality of life, poor palliation, and financial factors. An appropriate procedure for stopping life-sustaining treatment is shown in Table 1.

The Limits of Patient’s Preference

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The authority of a patient’s preference is not unlimited. The ethical obligations of the physicians are defined by the goals of medicine. As physicians, we have no obligations to perform actions beyond those goals or contradictory to them. Therefore, patients have no right to demand that physicians provide medical care that is contraindicated such as unnecessary surgery or unorthodox and eccentric drug regimens. Patients cannot demand that physicians do anything illegal or unethical. Patients or authorized surrogates may express a preference for continuing life support by all available means even when physicians judge a medical intervention to be ineffective or futile. Such a situation may bring intriguing and important conflicts between medical indications and patient preferences. Physicians are not obliged to prolong organic life when that is the only medical effect that intervention can achieve. Physicians are neither mere technicians nor indentured servants for autonomy. In cases in which medical benefits are low or nonexistent and the quality of life is below minimal, contextual factors such as alternative use of resources may be weighed more heavily. Quality of life judgments are not based on a single dimension nor are they entirely subjective or objective. They must take into account personal and social function, performance, symptoms, prognosis, and subjective values that patients ascribe to quality of life considerations. Two important questions must be raised: (1) who is making the evaluation, the person living the life or an 364

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observer? and (2) what criteria are being used to evaluate? Finally the crucial ethical question can be raised as to what sort of clinical decisions, if any, are justified by reference to a quality of life judgment. One other outcome may occur if the outcome of the institutional process coincides with the patient’s desires but the physician remains unpersuaded. In such a case, arrangements may be made for transfer of the patient to another physician within the institution. Alternatively if the outcome of the deliberation process coincides with the physician’s position but the patient or the proxy remains unpersuaded, arrangements for transfer to another institution may be sought. If this path is taken, the transferring institution should be supportive and helpful and the accepting institution and physicians should be comfortable honoring the patient’s and/or proxy’s wishes. Finally, if transfer is not possible because no physician and no institution can be found to follow the patients and/or proxy’s wishes, it may be because the request is considered offensive to medical ethics and professional standards in the eyes of the majority of the health care profession. In such a case, by ethics standards, the intervention in question need not be provided, although the legal ramifications of this course of action are uncertain. This fair process approach insists on full and fair deference to the patient’s wishes, placing limits on this patient-centered approach only when the harm to the patient is so unseemly that even after reasonable attempts to find another institution, a willing provider of the service is not found. This approach has the additional advantage of being open, allowing for a sense of fairness for all parties in an era when cost containment and other driving forces stress compromise. The American Medical Association proposes giving priority to patient or proxy assessments of worthwhile outcome.28 This process can accommodate community and institutional standards and the perspectives offered by the quantitative, functional, and interest approaches that involved parties may bring. A fair process approach also provides a system for addressing the ethical dilemmas regarding end of life care without the need for recourse to the courts.

Planning for End-of-Life Quality end-of-life care is recognized as a health care issue that deserves more attention.29,30 An important element of quality end-of-life care is advanced planning,31 a process of communication among patients, the health care provider, their families, and important others who will be involved in the kind of care that will be considered appropriate when the Curr Probl Surg, July 2003

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patient cannot make decisions.32 Advanced care planning may and generally does include written advance directives forms.33 Advance Directives. Patients are frequently concerned that, when crucial decisions must be made about their medical care, they will no longer be capable of participating in those decisions. In recent years, the concept of advance directives has emerged and has been widely promoted as a solution to that problem. The general term advance directives covers: (1) the legal instrument entitled “Directives to Physicians in a Natural Death Act” by various states, (2) the less formal living will, and (3) the durable power of attorney for health care. Advance directives have explicit legal validity in nearly every state. At least in principle, most people agree with the idea that individuals should be permitted to express their preferences concerning termination of life support in a legally effective document. In 1990, the United States Supreme Court stated that individuals have a constitutionally protected liberty interest in refusing a medical treatment; this interest is not extinguished after mental capacity is lost. This reasoning, after several decades in which the idea of advance directives has advanced, has become both familiar and accepted in ethics and law. In the future, advance directives will become an increasingly important feature of routine medical care and will be especially important in terminal care. In light of these developments, physicians should become familiar with the provision of advance directives, which may be validated legally in their locale. Physicians should know the differences between the 3 principal forms of advance directives. Natural Death Acts. Sometimes also called Death with Dignity Acts, Medical Treatment Decision Acts, and so forth, these are statutes passed by state legislatures. They affirm a person’s right to make decisions regarding terminal care and provide directions about how their right can be affected after the loss of decision-making capacity. Typically, they contain a model document called Directives to Physicians. These directives are typically worded as follows: if at anytime I should have an incurable injury, disease or illness certified to be a terminal condition by two physicians and where the application of life sustaining procedures would serve only to artificially prolong the moment of my death and where my physician determines that my death is imminent, whether or not life sustaining procedures are utilized, I direct that such procedures be withheld or withdrawn and that I be permitted to die naturally.

Durable Power of Attorney for Healthcare. This statute has also been passed by state legislatures. It authorizes individuals to appoint another person to act as their agent to make all health care decisions after they become incapacitated. This statute is particularly useful to physicians and 366

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hospitals because it authorizes a specific decision-maker that presumably is familiar with the patient’s wishes and values to make choices on behalf of the patient. This clarifies the confusion that often exists about which family member is the appropriate decision-maker for an incapacitated relative. This also avoids bureaucratic burdens and the costs of a legal proceeding to appoint a guardian or conservator. Living Wills. Advance directives may be communicated by patients to physicians, family, and friends in a less formal, less legalistic fashion. The operative words in many living wills are: if the time comes when I can no longer take part in decisions for my own future and there is no reasonable expectation of my recovery from extreme physical or mental disability, I direct that I be allowed to die and not be kept alive by medication, artificial means or heroic measures.

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Even if there is no explicit legal recommendation or personal documents, physicians can and should respect and act on them as expressions of the patient’s preferences. Written advance directives are important innovations because they express the patient’s preferences. They allow individuals to project their preferences into the future for consideration by those responsible for their care, when they themselves are incapable of expressing preferences. Advance directives do, however, present some problems to those to whom they are addressed. As written documents, they employ terms that are vague such as “if there is no reasonable expectation of recovery” or the direction to “forego artificial means.” Such language is ambiguous because each case requires interpretation. In addition, this directive does not specifically indicate which treatments the patient wishes to forego. Although these documents are helpful as evidence about the patient’s prior preferences, they are no substitute for thoughtful and responsible interpretation of a particular case. The original goal of the movement for advanced care planning was to assist patients to make treatment decisions in the event of incapacity. However, from the patient’s perspective, the primary goal of advanced care planning is more commonly to prepare for death.34 People struggle to find ways to cope with death.30 Once a central ritual of social and religious life, death has been privatized, desacralized, hidden behind institutional walls, and treated as taboo. Advanced care planning can now help prepare for death, which from the patient’s perspective tends to mean helping sense of control, relieving burdens on loved ones, and strengthening or reaching closure in relationship with loved ones.34 Advanced care planning can help people achieve a sense of control by thinking beyond an itemized list of concrete objectives to map a personal approach to dying by considering the values and goals that should guide their dying. Advanced care planning also allows people to determine Curr Probl Surg, July 2003

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settings for care and limits for life-sustaining treatments. Advanced care planning may also help prepare those who serve as substitute decisionmakers in a crisis and mitigate the guilt felt by loved ones who must make difficult decisions about life-sustaining treatment. Advanced care planning can help the health care team to be prepared for the patient’s death. Advanced care planning is a process of communication and events. Directives forms are best viewed as an assisting device in the advanced care planning process.34 Advance directives forms can facilitate advanced care planning as educational tools or worksheets that give structure and clarity to discussions and guidance on how many people think about issues concerning death, illness, and end-of-life care. Advance directives forms may help people to articulate their values, goals, and preferences and can provide a framework to facilitate discussions with others. Thus, an advance directives form is far more than a legal document that merely records an individual’s proxy choice and treatment preferences. To proceed with advanced care planning, individuals should choose a form that meets their needs and then use it as an aide to discussions about dying and end-of-life care. The focus of these decisions should be on achieving a sense of control, relieving the burden on loved ones, and strengthening relationships. If questions arise about prognosis or treatment, a physician or other health care professional can address them. Finally, the advance directives form can serve as a vehicle for documenting preferences that will help when substitute decisionmakers are unsure.35 Advanced care planning has commonly been considered within the context of the patient/physician relationship. However, advanced care planning is also, in a sense, primarily a process of communication between people and their loved ones. Studies have shown that patients are much more likely to have advanced care planning discussions with loved ones than with their physician.36 Patients do not always understand the medical implications of their documented preferences and physicians have an important role in fostering understanding and implementing care.37 In some specific medical situations, preferences may be difficult for health care providers or proxies to interpret especially if they were not part of the advanced care planning discussions. Therefore, it is helpful for clinicians to answer questions, clarify issues, review completed advance directives forms, and ensure that their patients have understood the relevant medical information. Physician-identified barriers to communication also exist, including discomfort with talking about death and dying, lack of knowledge, difficulty determining appropriateness, and time constraints.38 Open, unhurried, communication initiated by a trusted 368

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physician who is able to speak comfortably and competently may help overcome barriers and facilitate communication. The physician’s role in advanced care planning should be supportive and sufficiently participatory so that preferences can be well understood and translated into clinical care. Physicians may raise issues, direct patients and families to appropriate resources, provide information about diagnosis and treatment concerning their patient’s individual health situations, and address information needs as they arise. They also help to ensure that proxies are involved in the process, and review the results of the process with them. Advanced care planning is just like most quality clinical encounters in medicine. The physician has a key but not an all-encompassing role. The key participants are patients and their loved ones. It is important to emphasize the importance of timely communication about treatment planning and goals, with special emphasis on the use of advance directives in some cases.

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Although there is an established consensus in our society that competent adults have the right to make treatment decisions for themselves, decision-making for incompetent adults is much more problematic. When people cannot make decisions for themselves, it is necessary to turn to advance directives or surrogate decision-makers. Both a living will and durable power of attorney become operative only when the patient is determined to be unable to participate in decisions about his or her clinical treatment.39-41 This determination can be made by clinicians and unless formally challenged, does not require active participation by the legal system. Another form of advance directive, much less commonly used, is called a values statement or values history. Rather than give specific instructions or appoint a proxy to make decisions, the values statement attempts to represent the patient’s general values (such as religious beliefs, quality of life preferences, etc.) with which treatment decisions should be consistent.42

Problems and Benefits of Advance Directives Despite the Patient’s Self-Determination Act and widespread educational efforts and publicity, relatively few patients admitted to the hospital claim to have filled out a formal advance directives form.43 Some studies indicate that most patients want to talk about advanced directives but are waiting for their physicians to bring it up.44 One large study to assess the effectiveness of advance directives on the care of dying patients found that they have no impact on physician/patient communication or how Curr Probl Surg, July 2003

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do-not-resuscitate orders were written. In a review of more than 100 research articles on advanced care planning and advance directives forms, Miles and colleagues concluded that advanced treatment preferences have been shown to be difficult to form, communicate, and implement.33 Living wills are too often vague in the direction they give for both the event not to be treated and the level of treatment desired. Some authorities have suggested more specific living wills that dictate specific choices about treatment options.39 Although most states’ advance directives laws require that patients be terminally ill before their living wills can go into effect, some legal scholars have pointed out that the U.S. constitution gives patients the right to make their own decision about treatment whether they are terminally ill or not.45 There is also now growing evidence that families and health professionals often ignore the wishes expressed in patients’ living wills.46 Scrutiny of the data reveals 2 compelling reasons why this apparent disregard of a patient’s wishes may be quite acceptable under some circumstances. The first has been discussed above. Living wills go into effect when the patient is no longer able to speak for himself or herself and under certain circumstances the surgeon or family might decide that the ratio of harms to benefits would clearly be served by operation and therefore, operation is performed even though the patient might have requested no surgery. Similarly, relief of pain by operation might be impossible, even though the patient has requested operation and it might be decided, in the case of an incompetent patient that he or she might be best served by not having the procedure. When a patient is unable to make medical decisions, it is assumed that surrogate decision-makers should make judgments that would reflect a patient’s choices or values, a standard known as substituted judgment. Justification for respecting substituted judgment rests on the notions of autonomy and self-determination as reflected in our political system, laws, and ethical theories.47 When circumstances arise in which a patient’s directives conflict with the treatment chosen by the surrogate or care-giver, legal opinion has tended to support the notion that patients should have their directives respected.41 It is generally assumed that patients want their expressed wishes followed in end-of-life decisionmaking and that patients would want their wishes implemented even if surrogates were to disagree with them. Interestingly, however, Terry and colleagues48 found that many of the patients who had filled out advance directives wanted surrogates who disagreed with the advance directives to use their best judgment about clinical decisions. Previous studies indicate that surrogates do not predict patients’ preferences accurately when both 370

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are asked to respond to hypothetical situations.49 These studies also raise serious questions about the implementation of advance directives. At the very least, the findings suggest that all patients with advance directives should be asked whether they wish to have their directives followed in the event that the directives are contested by loved ones. More broadly the findings suggest that we should ask patients more specifically about end-of-life decisions that may involve conflict or different interpretations of a desired treatment.

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Futility

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In the course of caring for a critically ill patient, it may become apparent that further intervention will only prolong the final stages of the dying process. At this point, further intervention is often described as futile. There has been controversy in the literature and in clinical practice regarding what constitutes futile interventions.28 Futility is an essentially subjective but realistically indispensable judgment. A fully objective and concrete definition of futility is unattainable. Webster’s Dictionary defines the term futile as serving no useful purpose or completely ineffective. However, people differ on judgments of usefulness, purpose, and ineffectiveness and how the 3 balance out, whether in medical or other affairs.50,51 Claims of medical futility inherently involve a value judgment.52 To impose an objective definition of futility would inevitably deprive some patients of interventions and to die according to judgments with which they disagree. In “The Art” the Hippocratical writer justifies refusing to treat those who are over-mastered by their diseases, realizing that in such cases medicine is powerless.53 More recently, medicine has considered setting limits on critical care in accession to inappropriate requests for lifesustaining interventions such as mechanical ventilation, parenteral fluids and nutrition, and pharmacological cardiac support. Limit setting now arises routinely in areas of postoperative treatment when the prognosis is futile.54 Futility means that the clinical intervention is reliably expected not to have the intent of a therapeutic effect. Clinical applicability of this definition requires that the desired effect be specific. McCullough and Jones have introduced 4 concepts of futility.55 The first 3 concepts appeal to the ethical principle of beneficence for the requisite specification. The ethical principle requires the physician to seek greater benefit than harm for the patient when assessing treatment risks. These aspects of futility are: physiological or a strict futility, where an intervention is futile in the sense it is unlikely to produce physiological benefits; overall futility, which is based on the likelihood that an intervention is to restore the Curr Probl Surg, July 2003

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patient’s ability to interact with the human environment; and imminent demise futility that involves a reliable expectation of death without prior recovery of consciousness. An additional aspect of futility involves qualitative judgments that quality of life (ability to participate in and enjoy life events) will be unacceptable for the patient. When dealing with this aspect of futility, it must be acknowledged that an observer’s estimation of the patient’s quality of life is often unreliable.56 When medical cases involve futility judgments, case by case evaluations using a fair process approach may well be the best available option. This approach acknowledges both the impossibility of obtaining objective assurance and a necessity for proceeding fairly. In medicine, and for futility policies, fair process approaches would likely be adopted at the institutional level for use in individual cases but could be adopted for larger communities such as religious institutions or even states. The emphasis of the approach is on fair process between parties rather than on having a definition that is externally imposed on the parties. Professional standards including use of clinical outcome measures, patient rights, intent standards, and family or community involvement should usually be accommodated in a process of deliberation.

Use of High-Tech at the End-of-Life

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The cost of dying in the United States is enormous. For the 6% of Medicare recipients who die each year, 50% of the total cost of health care is spent during the last 6 months of life; 30% is spent for medical care during the last 2 months, and a substantial 20% of total medical expenditures cover the last month of life. According to 1 estimate, as much as 80% of technologic advances apply to individuals who are beyond their fifth decade.57,58 These technologic advances have brought longer and healthier lives for many. At the same time, they have also enabled the sustenance of life beyond reasonable limits; many individuals are sustained in totally disabled bodies or in an unconscious state at enormous costs to themselves, their families, and society.59 The fee-forservice system that compensates physicians for expensive interventions has been blamed for much of this wasteful use. In addition, unrealistic patient and family demands, fear of litigation, and a passion for technology and a fear of death have contributed to the explosion of palliative care costs. Regardless of the reasons, the pace of technologic advances has exceeded society’s ability to regulate its use at all levels of care, particularly with regard to terminally ill patients, a pace that can no longer be sustained. As health care delivery in the U.S. has transformed

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from a fee-for-service to a managed care system, cost conscious guidelines are inevitable. Like all technology, medical technology is a double-edged sword. On the 1 hand, it enhances life by extending its length and improving its quality. On the other hand, it creates complex moral choices where none existed before. Experience has taught surgeons and patients that the application of this technology does not in all instances serve the wishes and best interests of patients. This realization has confronted surgeons, patients, and families with hard choices about withholding and withdrawing aggressive interventions such as intensive care, mechanical ventilation, hemodialysis, and cardiopulmonary resuscitation. As difficult as it may seem, practice guidelines regarding end-stage disease and medical treatment of the terminally ill patient are vital if we are to maintain a standard of care that is rational, redeeming, and worthwhile. In fact, a legal, ethical, and clinical consensus has emerged that extension of biologic life need not be the only goal of medicine; comfort and dignity are entirely appropriate goals when cure is no longer possible, and this goal should be pursued at reasonable financial and human costs to the patient, family, and society.

Managed Care in End-of-Life Discussions

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Nowhere is the heavy hand of managed care more likely to be felt as in the application of high technology to medicine near the end of life. The danger of unilaterally rationing medical care near the end of life through a fund regulated and monitored by administuators could prove to be extremely costly both to society and to the medical establishment by undermining the trust placed by patients in their treating physicians. Kuczewski brings to light an issue that is well worth mention: the way in which financial decisions at medical institutions affect patient care.60 Particularly in the United States, the issue of managed care comes into play where a patient’s insurance plans may not cover the length of stay in the hospital, especially in cases of end of life. Kuczewski argues for an ethical framework with 3 major tenets for dealing with this kind of information. First, all financial information should be disclosed routinely and update continually during the course of hospitalization. Second, disclosure of financial information should not be solely or even primarily, the responsibility of the attending physician but should include specialized personnel such as case managers. Lastly, financial information that affects decision-making should be a part of the medical record available to all members of the health care team. The very mention of the term managed care can carry negative ethical connotations to those committed Curr Probl Surg, July 2003

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to patient care and the fiduciary model of the physician/patient relationship.61 To them, this term suggests travesties, including the unwarranted denial of necessary services and the pitting of the physician’s interest in making a living against the needs of the patient.62

Palliative Care

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The decision to terminate specific forms of treatment and not to resuscitate does not imply the termination of care for the patient. It is frequently noted that after a DNR order is written, attention to the patient diminishes. This is unethical for 2 reasons. First, since in some series more than 50% of patients for whom DNR orders have been written have survived to discharge, these patients required continued appropriate care. Second, it is a failure to recognize that when the goals of curing are exhausted, the goals of caring must be reinforced. Attention to the relief of pain and discomfort and enhancement of the patient’s ability to interact with family and friends become the predominant goals. The medical proverb is pertinent: cure sometimes, relieve occasionally, comfort always. Much energy and time is being spent discussing euthanasia and assisted suicide when only 5% of dying patients in Canada receive palliative care.63 It has been said that the true measure of a caring society can be seen in the way it treats its most frail members. Dying people are frail and vulnerable. They have a right to society’s care and protection and a right to expect the best palliative care. It has been said that until all dying patients and their families have ready access to the full continuum of skilled and effective palliative care services, that the dilemma of euthanasia and assisted suicide cannot be addressed appropriately or safely. Clinical experience indicates that terminally ill patients rarely request euthanasia when they receive good palliative care from an attentive physician and team. Their symptoms are controlled and they are in a care setting that is appropriate to their wishes and needs.64 Health care professionals should strive for better ways of caring for dying patients rather than seek to take their lives. Palliative care is defined as a program of active compassionate care primarily directed toward improving the quality of life for the dying.65 At its core is the affirmation of life, even in the face of impending death. There is a shift of goals from the cure and prolongation of life to the alleviation of psychological and spiritual suffering, the relief of pain and other symptoms, and the enhancement of the quality of a patient’s remaining life. The patient and family are supported, guided, and accompanied as the life of the patient comes to a close. The unit of care 374

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is the patient and family and the circle of people who share their life. Making ethical decisions and setting goals for treatment with patients and their families is part of palliative care.66 In an appropriate clinical context and when consistent with the patient’s goals and wishes, the withholding or cessation of life-prolonging treatment may also be a part of such care.66 An appropriate clinical context usually implies that the burden of treatment outweighs the benefits to the patient, or that the patient does not wish to have the proposed treatment. Considerable care and thought must be given to assessing the particular approach to care for an individual patient. Decisions to withhold or to stop treatment should not be taken lightly. The balance between beneficence, respect for patient autonomy, justice, and nonbeneficence must be weighed. The presence of severe intractable pain and other severe end-stage symptoms, such as dyspnea and delirium with agitation, may sometimes require that the physician sedate the patient. The goal is to relieve severe symptoms—not to bring about death. The doses and types of medications used must be clinically appropriate. Unwarranted sedation of patients is not good palliative care. By making significant changes in the way patients do in fact live, good palliative care can often help deal with the problem of not wishing to live this way. Without a doubt, optimal pain control is the necessary condition for any meaningful palliation. Without good pain control, little else can be achieved. However, good pain control as essential as it may be, is only the beginning. When a patient is at the end of life, it is important to perform the so-called orchestration of the end of life as described by Loewy.67 This refers to creating conditions systematically and skillfully that allow patients to continue to enjoy and control what is left of their lives. Often, what patients seem to fear most is powerlessness.68 When all is said and done, powerlessness, social isolation, and incapacitation may be more feared than pain. Pain relief is a necessary condition of terminal care, and it is still often carried out poorly and inadequately. Pain control that is not accomplished expertly can decrease a patient’s ability to engage in meaningful activity, can increase the patient’s sense of hopelessness and dependence, and can interfere with social interaction. Much can be done to optimize a patient’s capacity for controlling his or her own fate and for translating his or her own wishes into consequent action; this is a central feature of orchestrating the end of life. It is meant to be an interdisciplinary activity, an activity that involves a variety of medical and nonmedical skills and disciplines. Often, but not always, the conductor will be a physician trained to select the proper individuals and to coordinate their activity. These individuals can come from a variety of skilled areas: Curr Probl Surg, July 2003

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physicians, specialists in pain management, nurses, social workers, dieticians, psychologists, and clergy members, among others. Patients and their families are active participants whose constant involvement is critical to success. Orchestrating the end of life is a skill that is altogether too rarely taught.69

The Surgeon’s Role in the Care of Dying Patients

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Most adults in North America die in institutional settings, and most of those deaths occur under medical or surgical care. Surgeons tend not to like death, especially after an operation. As a consequence of the first factor, surgeons cannot avoid dying patients and as a consequence of the second factor, surgeons tend not to speak candidly and specifically to patients about their situation and prospects. Dying patients confront surgeons with a number of ethical challenges, in no small measure because of these 2 factors and their consequences.70 Surgical practice predisposes surgeons to binary thinking. However, this common binary way of treating gravely ill surgical patients dooms such efforts to broad failure. If the surgeon waits until it is clear that the patient is dying before addressing the dying patient’s needs, many patients will end up being over-treated, their suffering will have been addressed inadequately, and attempts to help such patients and families come to terms with the patient’s death will be too little too late in most cases. This general population of dying patients usually lacks a comprehensive plan of treatment. These patients are often treated only partially, and without sufficient attention to the possibility that they may die regardless of whatever the surgeon does. Furthermore, as the patient’s death becomes more probable, their treatment, if anything, becomes even more abstract, haphazard, and unconnected to clinical reality. This problem becomes compounded when clinicians continue to be hopeful and encourage false hope in patients and families. The basic clinical question is, “What are the goals of care?” Once one elects to forego aggressive surgical treatment, it has been submitted that there are 4 basic goals: (1) to avoid prolonging the process of dying needlessly, (2) to keep the patient as comfortable as possible, (3) to secure whatever positive opportunities and quality of life that are still possible for the patient, and (4) to proceed with all this with patients and with their families having as full an understanding and input into the regimen of care as possible. There are several potential barriers to effective nonoperative clinical treatment. One significant barrier regards the role of the surgeon in fashioning the management of a dying patient’s care and the surgeon’s 376

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subsequent involvement with the case. The treating team and attending surgeon should assist the patient or family to fashion the specific details of a nonoperative plan of treatment, whether or not any of these individuals will be the actual providers of that treatment. It should be apparent at this juncture that simply writing a DNR order for the dying patient and transferring him or her to the floor or discharging him or her to the community is inadequate and inappropriate. The team that has gone through all that has led up to the decision to opt for palliative care has been informed by the experiences and insights and relationships and therefore remains an essential resource for developing the plan of care. The surgeon should remain engaged with the dying patient’s care, even if he or she in no way provides that care. The surgeon should at least let the patient and family know that he or she is available if problems arise.70 As surgeons, we do not always have a satisfying operative solution for a persistent problem. But the question remains: How do we conceptualize these encounters so we can be of service without having to withdraw or refer to someone else, someone who may not have our skills or our knowledge regarding the patient? Surgeons are not alone in yielding to the temptation of viewing the end of life as a stage of a disease that must be controlled.71 In the assessment of the whole person and his or her family, the authors of the American Medical Association’s Education for Physicians in End of Life Care (EPEC) curriculum have introduced an assessment screen consisting of 9 dimensions.72 This assessment was based on an extensive experience with patients having chronic and terminal illnesses, many of them under the care of surgeons at some point in the course of their illness. The EPEC curriculum is highly recommended to surgeons seeking a comprehensive understanding of the philosophy and techniques of palliative care. Each surgeon must find a comfort level in the degree of exploration of the different dimensions, just as each surgeon would pursue different aspects of care to varying degrees after a trauma assessment. To paraphrase 1 exponent of palliative care in critical care settings, the surgeon should not only be able to save lives but also save deaths.73 If surgeons require assistance in any of the areas assessed, there should be no hesitation in seeking consultation from palliative care specialists and other multidisciplinary teams working in specialized environments. Through the 1990s, these resources have proliferated rapidly in the major academic and regional medical centers in the United States and Canada. Hospice, the original program of palliative care, is also available for referral in a wide variety of settings for guidance and palliative care at Curr Probl Surg, July 2003

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life’s end. The staging procedure for palliative care creates a unique bond, not unlike that which forms between the surgeon and an individual patient he or she has operated on. Because of the inherent vulnerability of a patient revealing his or her innermost fears and yearnings while in a physically precarious condition, this intervention is as invasive as any anatomic operation performed and deserves the same attention and skill. This cognitive operation is based on many small, careful steps and a few big steps, some of which are irreversible. With appropriate care, surgeons have every chance of doing this as well as their nonsurgical colleagues.

Education of Surgeons and Palliative Care

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Medical educators and policy makers are increasingly stressing the need to enhance training in palliative care and the ethical issues engendered at the end of life.74 Despite recent progress and heightened national interests in end of life educational efforts, formidable attitudinal barriers still thwart the successful integration of palliative care into general medical education. Medical students and residents are uncomfortable facing death and dying. A prevailing medical culture continues to view death as a medical failure. Palliative care, despite its growing scientific base, is often perceived as low tech or soft. Many trainees do not view palliative care skills as core clinical competencies. They learn to prescribe antibiotics, but they fail to master the use of opioids. These attitudes coalesce into practice patterns that devalue the provision of palliative care even though the public increasingly asserts the importance of humane medical care at the end of life.75 Fins and Nelson describe a process designed to educate residents about palliative care and clinical ethics based on the fact that many residents will be dealing with these issues during their training rather than as medical students who will only do so much later on.76 Their course outlines the basic structure for issues dealing with ethics and palliative care and each session involves cases from the resident’s own clinical experience that touched on the themes listed in their 6 seminar series. The seminars are based on the following: (1) professionals and physicians facing death, (2) cross-cultural issues at the end of life, (3) pain, suffering, and withdrawal of life-sustaining therapy, (4) brain death, (5) pain and symptoms management, and (6) institutional issues in palliative care. Building on the resident’s own clinical experience effectively engaged their interests and provided needed instruction in this evolving field of medicine. Educational strategies such as this provided residents an opportunity for critical self-reflection and provided the young physicians

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the opportunity to develop their skills and attitudes necessary for the humane care of the dying.

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Elizabeth Latimer states very clearly that in treating dying patients, who by virtue of their physical and emotional situation are frail and vulnerable, physicians must meet a high standard of professional care.76 Such a standard is based on a philosophy of care that recognizes the patients’ inherent worth as human beings and uniqueness as individuals. The ethical and virtuous physician will practice in accordance with the principles of biomedical ethics that form the foundations of thought and treatment approaches in this area and will seek to do the best for the patient and the family. Doing the best includes respecting autonomy through gentle truth telling, helping the patient and family to set treatment goals, and providing for symptom control, continuing attentive care, and accompaniment throughout the course of the illness. Total care includes physical, emotional, and spiritual aspects, is sensitive to cultural values, and is provided by an interdisciplinary team. Practices of symptom control in routine cases and in crisis situations, as well as the cessation and noninitiation of treatment, will have as their goals, the relief and comfort of the patient.

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Ethics and Research in Surgery

Surgical research examines and evaluates innovations and conventional ideas related to surgery through scholarly analysis of data and the generation and investigation of hypotheses. The subject of surgical research may include any topic that a thoughtful surgeon or curious scholar thinks will benefit the science and practice of surgery. Surgical research includes both laboratory and clinical experiments.77 A physician’s moral obligation is to offer each patient the best available treatment and this cannot be separated from clinical imperatives to base any choice of treatment on the best available evidence. The tension between the interdependent responsibilities of giving care that is personal and compassionate and treatment that is scientifically sound and validated, is intrinsic to the practice of medicine.78 Research ethics is as integral a part of scientific judgment as clinical ethics is of clinical judgment.79 Many ethical issues in research arise from a failure to think as rigorously about the conditions for ethical consistency as about those for scientific validity. The ethical principles governing all surgical, clinical, and biomedical research with human subjects are fundamentally the same. They have been listed and discussed in numerous documents and countless publica-

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tions over the past 40 years.80 Although due regard must be maintained for the utility and necessity of institutional review boards, ethics committees, and public participation in the ethical evaluation of protocols for research with human subjects, it is a mistake to view ethics as an external, authoritarian imposition of regulations or possibly arbitrary constraints on the process of clinical research. The design and the practice of research ethics should be primarily, though not exclusively, a matter of selfconsistency and self-governance within clinical investigations. An over-reliance on initial observations, potentially distorted by bias, can lead to a systematic divergence from the truth. Rigorous research methods are devised precisely to counter the tendency to mistake a mere semblance of correlation for a judgment of fact.81 The history of medicine and surgery clearly demonstrate the harms done in the name of treatments of unproven worth. Surgical examples include routine episiotomy, internal mammary artery ligation for angina, gastric freezing for peptic ulcer disease, initial attempts with inflatable devices to provide artificial support of the circulation, indiscriminant adoption of endoscopic (especially laparoscopic) surgery, and various operations for disparate forms of cancer. To the extent that uncontrolled reports favor an operation and an accumulation of such reports contributes to a possibly mistaken view that the operation provides benefits, conducting more definitive trials becomes more and more difficult, even subject to claims of being unethical.82,83 Research ethics should be a fundamental component of training for surgical research, just as formal and informal exposure to statistical methods has become an expected part of the researcher’s education.

Informed Consent

An informed competent patient’s preference to accept or to refuse medically indicated treatment carries great ethical, legal, and psychological importance. Patient preference is the ethical and legal nucleus of a patient-physician relationship. Patient’s preferences are ethically significant because they make explicit the values of self-determination and personal autonomy that are deeply rooted in the ethics of our culture. The usual vehicle for the expression of patient preferences is the process of informed consent. It is a practical application of respect for the patient’s autonomy. Informed consent is defined as the willing acceptance of the medical intervention by a patient after adequate disclosure by the physician of the nature of the interventions, their risks and benefits, as well as a discussion of alternatives with their risks and benefits. Disclosure is judged to be adequate by 2 standards: (1) information that is commonly provided by competent practitioners in the community of

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their specialty and (2) information that would allow a reasonable person to make prudent choices on his own behalf. The moral and legal obligation of disclosure varies in terms of the situation. It becomes more stringent and demanding as the treatment situation moves from emergency through elective to experimental. In some emergency situations, very little information can be provided. When treatment is elective, much more information should be provided. It should be understood that detailed and thorough information should accompany any invitation to participate in research, particularly if the research maneuver is not directed to the patient’s therapy. The phrase informed consent stresses the giving of information. The physician has an ethical obligation to make reasonable efforts to assure comprehension. Explanations should be given clearly and simply and questions should be asked to assess understanding. Written instructions or printed material should also be provided. The process of informed consent for research is not easy. The physician may be trapped in technical language, troubled by the uncertainty intrinsic to all medical information, worried about harming or alarming the patient, and hurried and pressed by multiple obligations. Patients may be limited in understanding, unattentive, and distracted, overcome by fear and anxiety. In the medical setting, a patient’s capacity to consent to or refuse care requires at least an ability to understand the information, to appreciate one’s medical situation and its possible consequences, to communicate a choice, and to engage in rational deliberation about one’s own values in relation to the physician’s recommendation about treatment options. In many situations, clinicians rely on family members to make decisions for marginally or totally incapacitated patients. Although this common practice may often be reasonable, it may not always be prudent. For example, patients and family members may have private value conflicts or unrevealed conflicts of interest. Patients who are compromised by their illness may be afraid to disagree with family members for fear of losing the psychological support they need or desire. Patients also need to absorb, retain, and recall what the surgeon has said. This need can be met effectively by using a vocabulary level not above the tenth grade, and adjusted lower as necessary. The patient needs to understand what he or she is authorizing. The patient needs to grasp the nature of the procedure or research goals, expected duration, and potential sequelae. All clinician researchers should honor the ethics of clinical research by abiding by the requirement of informed consent of subjects and review of protocols by competent bodies. Soundly designed clinical trials should have oversight mechanisms to monitor trends, to deal with the problems of clinical impressions, and to terminate the trial should the evidence of Curr Probl Surg, July 2003

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distinct benefit or harm become pervasive. Properly utilized, informed consent provides the basis for a strong and enduring therapeutic alliance between the surgeon and patient, with shared responsibility for decisionmaking. Consent for research innovation is imperative because the patient’s interests are put at additional risk by the investigational or innovative nature of the surgical procedure being offered. A long and disturbing history of abuse of research subjects has led to an oversight apparatus.84 How much change must occur to constitute an innovative approach and call forth an open and unbiased effort to assess the effectiveness of a new treatment? Surgeons have frequently resisted such a question, citing the difficulties of judging their work adequately. It is likely that surgeons will more and more need to demonstrate that their preferred approach has solid scientific justification and that new techniques accomplish what they are designed to do. Whether a greater examination of surgical practice will involve formal research protocols or the quality assessment measures of hospital, insurance companies, and managed care organizations, surgeons will need to consider the risks and benefits of adopting new techniques. Historically, there was no pressure for publicly articulated social controls on medical and surgical research on humans in the United States until the advent of Nazi medical experiments.85 Beginning in 1966, the public health service required that all research had to have supporting evidence.86 In 1979 the Belmont report was issued and this laid out of the foundations for many of the changes in federal regulations that took effect in the 1980s and remain in force today. Of special importance to the surgical community, the Belmont report noted that major innovations or radically new procedures should be made the object of formal research at an early stage to determine whether they are safe and effective.87 The Belmont report also affirmed the critical role that the informed consent of research subjects should play before investigations can proceed. The standards for research consent, the commission noted, need to be higher than standards for consent in medical practice because one cannot presume that participation in a scientific endeavor benefits the subject. The prospective research subject, generally speaking, has no immediate obligation to participate in any proposed investigation. The issue of the risks and benefits of so-called therapeutic research has received voluminous attention in the medical literature. Recently Shim and Spece summarized the problem this way: the clinician has a fiduciary responsibility to his or her patient and the clinical investigator has additional and at least potentially conflicting responsibilities to the 382

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scientific enterprise (ie, to science itself, to society, to those who support the research, and to the institution where the investigation takes place).88 In any given circumstance, it may be very difficult to tell where the investigator’s primary loyalty does or should lie. Those who value generation of knowledge as a transcendent good will, of course, claim the primacy of the research project. Where the ordinary therapeutic researcher stands, it is not clear. Even when research is part of their medical care, patients must be told what they are participating in and that they may opt out of the research. More difficult questions arise when the research is performed in an emergency.89 If the research is part of urgent care and the patient cannot consent, the research protocol should be scrutinized carefully beforehand. Such research is usually allowed only if the treatment options being studied are all reasonable ones that put patients in no known excess danger. Patients who are desperately ill and not expected to survive with traditional treatment are often recruited into experiments that test novel therapies. Such desperate patients are especially vulnerable to subtle coercion. They are unlikely to be capable of giving autonomous or ethical consent since research holds out the only hope of survival. Such “last ditch” experiments are morally dubious.90 The therapeutic obligation in clinical practice, regardless of whether physicians and patients are participants in a controlled clinical trial, must be governed by the ethics of proportionality. Risks of harm or detriment must be balanced by a probability of benefit for the patient that is weighty enough to compensate for any loss or injury that might occur. This principle complements the Nuremberg and Helsinki emphasis on proportion to be maintained between the risk undertaken by subjects in clinical research and the scientific and humanitarian importance of the research objectives.91,92 The requirement for participation in research is that subjects must give informed consent to participate. There can be no exceptions to the ordinary requirements of disclosure in the case of research as there may well be in ordinary medical practice. The research subject is entitled to full and frank disclosure of all of the facts, probabilities, and opinions which a reasonable person might be expected to consider before giving his or her consent.93 Medical research must be undertaken only with patients who are capable of giving their consent and who are fully informed of the potential risks of being included in a research trial. In all cases of research, consent forms must be used and are expected to meet the highest standard of clarity, disclosure, and protection of the research subject. The involvement of the research subjects must be free of duress and the research must be conducted without deception and conflicts of Curr Probl Surg, July 2003

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interest. Physicians are advised to be familiar with the details of their local research ethics protocol. Unfortunately, the standards of these protocols vary widely.94 Protection of privacy and confidentiality are professional obligations arising from the fiduciary character of the relationship between patient and physician. It is a necessary condition for the ethical conduct of surgical and clinical research with human subjects. When intimate information is divulged without a patient’s knowledge and consent, and, worse when explicit promises of confidentiality have been broken, the integrity of sick people is harmed, and so is the integrity of clinical practice and clinical research. Clinical studies involving follow-up of patients after closure of the study require that particular attention be given to protection of privacy. Research subjects should be alerted to the possibility of future contact and they should give free and informed consent to any follow-up plan.95 Several problems face doctors who enroll patients in clinical research protocols. To begin with, how can the patient’s right to determine the type of treatment he or she is prepared to accept, which much be based on understanding possible medical and social consequences as well as the technical details, be reconciled with the doctor’s duty to act in what he believes to be the best interests of his patient. This dilemma must be offset against the scientific needs to test new treatments that offer the potential of better care for future generations of patients. Finally, and most importantly, the doctor must consider what effect such disclosures will have on the individual patient. The doctor who wishes to enter patients into a randomized trial can do so only if he honestly does not have a preference for a particular treatment.96 In the trial, a doctor who seeks informed consent must admit to his patient that he does not know which is the best treatment. He may have to explain the reasons for random selection. He certainly must discuss any possible side effects, and he may have to disclose more about the prognosis than he would wish. Not unnaturally, a compassionate clinician is concerned that by so taking a patient into his confidence and declaring his own uncertainties, this will undermine his patient’s trust in him and thus adversely affect the outcome of treatment. Are these fears justified? To some extent they can be tested only by experience, but evidence suggests that uninformed patients may also be alarmed, anxious, and subject to considerable stress precisely because they are being kept in the dark. They may privately suspect that bad news is being kept from them. 384

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Surgical Innovation

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To the extent that one claims that we simply cannot know adequately whether a new intervention will, in the long run, turn out to be more beneficial than harmful, any new treatment should be subjected to formal research scrutiny at the earliest possible stage. From this perspective, there should be no innovation without a research protocol. Others, however, believe that they have an obligation to use their clinical knowledge to do what they can for patients, even under conditions of uncertainty about the true value of an operation, a device, a drug, or some other treatment. This claim is made all the more strongly when the clinical situation is desperate and when past approaches have not been helpful and when the clinician believes he or she has some especially promising innovation to address the problem at hand. Practically speaking, new ideas come along at a furious pace and many obstacles exist including time, money, and bureaucracy, which inhibit or discourage the conversion of innovative ideas into formal research protocols. The difficult question is, at what level, does deviation from the standard approach (which we must remember may itself not have been proven adequately in the scientific arena) create a moral obligation for a test by research criteria. Perhaps if the change is minor and the stakes are low, informal innovations should not be tested rigorously. Lantos suggests that we get into trouble thinking about these issues because of the different goals of research and practice.97 Research aims at knowledge; practice aims at helping patients. Innovation in the name of treatment receives relatively little scrutiny even though the actual risks may be quite high. One could add that great economic, academic, and psychological rewards may come to the innovator, well before he or she shows a new technique to have definite worth. Perhaps we should appreciate that research has not automatically created greater hazards for patients than what they face through the loyalty of a compassionate but uncurious clinician and that when given an opportunity to participate in decisions about how to proceed with innovations, patients (subjects) will accept the formalized research approach to innovation.97 Therefore, one way to finesse the research/innovation dilemma is to draw those most affected by concerns (ie, the scientist, the clinicians, and community of patients and their loved ones) into a collaboration designed to minimize, if not eliminate, the difference between the approaches and allow the development of protocols when innovation is contemplated. It is sometimes difficult to distinguish research from innovative treatment. A physician may choose to employ a drug for a condition for which Curr Probl Surg, July 2003

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it has never been used. The clinician may do so primarily as a last resort in the care of a particular patient and without the intention of developing generalized knowledge even though the clinician may be able to draw some conclusions in retrospect. In research, the intent to develop generalizable knowledge is the primary driver and this instigates the development of a research plan and the use of methodologies useful in the gathering, analysis, and validation of information. Innovative treatment is not as such governed by the rules and regulations of research. However, it should be governed by the same spirit. The advice of knowledgeable colleagues should be sought, a risk benefit ratio as accurate as possible should be worked out, and the consent of the patient to be the subject of yet untried treatments should be obtained. In addition, innovative treatments should be designed as closely as possible to research, so that the social benefit of valid knowledge can be obtained. Finally, the clinicians should seek the advice of the IRB about the advisability of an innovative treatment. When there is uncertainty or definite doubt about the safety and efficacy of an innovative or established treatment, the position of professionally validated knowledge supports the strong view that there is, not simply may be, a higher moral obligation to test it critically rather than to prescribe it year in and year out.98 When large numbers of innovative treatments are being continuously introduced into clinical practice, rigorous testing is ethically mandatory for the protection of individual patients and the just use of limited resources. This holds true with even greater force in the light of evidence that many innovations show no advantage over existing treatments when they are subjected to properly controlled studies.83 To conduct a clinical trial, 3 conditions must be met:99 (1) a genuine uncertainty, or equipoise, must exist within the medical community regarding the comparative merits of the treatment arms of the trial; (2) the trial must be designed so that if successful, it will disturb equipoise (ie, the trial should be continued until the difference is convincing enough to resolve the dispute among clinicians); and (3) finally, the rights of the patients to protection in the pursuit of their best interests must be safeguarded. Emerging surgical techniques are generally touted in the medical literature and in the press because of the benefits they are expected to offer. Only after broad application of new procedures do the harms that may result from their application become evident. It should be apparent that maximal patient benefit will occur only when new procedures can be performed with minimal complications (ie, with a minimum of harm). No surgical approach can benefit a patient if her surgeon has not yet acquired adequate knowledge about the procedure and skill necessary to perform it 386

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safely. It is this concern over harm that limits the early application of new therapeutic techniques and supports their development in the context of clinical trials with built-in mechanisms for patient protection. The use of clinical trials also allows the hope for benefits of new techniques to be substantiated while potential risks and complications are described and patient selection criteria are defined.100 A bond of trust is fundamental to a relationship in which a patient permits a physician to apply skills at which he or she is not yet proficient. Just as trust can be strengthened before a procedure by full disclosure, trust should not be undermined by a failure to disclose that a complication has occurred or that a mistake has been made. Complications may arise because a relatively inexperienced surgeon is unaware of common pitfalls and is therefore, unlikely to anticipate and avoid them. An honest commitment to patient welfare is essential on the part of those who are learning. Those who already possess expertise should mentor others.

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Informed Consent and New Surgical Procedures

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The acquisition of new surgical skills has particular implications for the process of informed consent. When a new surgical procedure is being offered, the information that a patient receives can be influenced in several ways. Patients often come to physicians expressing an interest in a particular new surgical approach. It is natural for a physician who is in the process of learning a new operation to be enthusiastic in responding to a patient’s queries about it. It is important, however, that a patient’s enthusiasm not become a means of manipulating a decision about actually undergoing a surgical procedure. A frank discussion of what is and is not known about the short- and long-term outcomes of new procedures should be undertaken. This should include a statement as to whether the procedure has been proven to be more effective than a traditional approach. Advantages and disadvantages of the new and traditional approaches should be reviewed. Throughout the discussion, the physician’s own level of experience should be explicitly factored in. A physician should be honest about his or her qualifications to perform a procedure and his or her personal experience with it. He or she has an obligation to disclose this information accurately, whether the patient does or does not request it. This obligation may give rise to discomfort, as the less experienced physician will certainly perceive that the patient may respond by choosing a more experienced surgeon. If the procedure is to be proctored or if a mentor will be present, this should also be shared with the patient. If the goal of the process of informed consent is to enable patients to make free and informed decisions about their medical care, this

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kind of disclosure is essential. Open and honest communication builds a sort of trusting relationship that a patient may value over the repeatedly superior skills of an unknown expert. The distinction between clinical practice and surgical research may seem trivial, but this distinction can become a complex issue when innovative operations are substituted for standard care without patient knowledge. Neither the novelty nor the risk of a new surgical procedure adequately defines surgical research. The medical profession has largely ignored the ethical tensions associated with the introduction of new procedures and the transfer of surgical procedures from the laboratory to the operating room. In this area of experimental therapeutics, the patient-physician relationship is vulnerable. When the procedure departs substantially from the standards of care, it should be studied for safety and effectiveness at the earliest time possible. Because there are no guidelines that define threshold levels of clinical innovation or acceptable added risk, the responsibility for judging when a new or novel clinical practice becomes research rests solely with the individual surgeon.101 Unlike drugs, medical devices, and other products that require demonstration of safety and effectiveness before approval by the Food and Drug Administration, there are no regulations describing how a new surgical procedure should be tested. Currently there is greater oversight protection in place for laboratory animals than there is for testing innovative surgeries in humans. The proponents of any new treatment are naturally enthusiastic and commonly have an almost total and uncritical belief in their new ideas. It would therefore be easy for them to persuade patients to accept this new treatment particularly if the patient was suffering from a potentially fatal disease and had exhausted conventional treatment, even though the new treatment might impair the length or quality of survival. Furthermore, as a result of either systematic or random bias, the results of treatments from uncontrolled studies, performed by enthusiasts, almost always look encouraging, and therefore a position is rapidly reached when the clinician concerned begins to think it is unethical to withhold a new operation or wonder drug. As a result it may take up to 30 years before the unfortunate side effects become recognized102 or before careful and critical scrutiny shows that any apparent benefit may be ascribed to selection or the placebo effect.103 A basic premise used in the approval of an experimental protocol by human investigation committees is for a study to be considered ethical; it must be able to produce scientific results. If scientific results cannot be obtained, the experiment is unethical at inception.104-106 The same criteria 388

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should hold true for surgical innovation. Belief in the effectiveness of a procedure without substantiating data are unacceptable and reminiscent of the science behind blood-letting.105 The wrongs in surgical innovation within our medical culture are twofold. First, procedures are introduced into the medical literature without appropriate mechanisms for scientific validation. Second the procedures are accepted by others in the medical profession without demanding validation. In time we must find an angle of repose, not only in our own lives but also as a community working together with common purpose.107 The angle of repose will be found by balancing the need for creative innovations with respect for patient autonomy. The angle of repose will be found in the balance between medical progress and safeguarding the rights of our patients.

Maintaining Trust in the Surgeon-Patient Relationship

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Consisting of biomedical investigations that involve human subjects, clinical research is an important and complex activity. Although advances in medical care depend on sound clinical research, the pursuit of science by clinical investigators in some cases has exploited or caused harm to patients and normal volunteers.108-110 In view of this history and the continuing potential for abuse, clinical research is periodically under attack. In addition, the growing role of the pharmaceutical industry in funding clinical research has raised questions about conflicts of interest with investigators who have received industry financial support.111 The continued viability of clinical research depends on public trust in the integrity of this enterprise. The predominant societal response to the ethical problems associated with clinical research during the past 30 years has been the implementation of regulatory mechanisms, including detailed federal regulations governing research involving human subjects and institutional review boards that examine and approve scientific protocols and written informed consent forms.110-112 Nonetheless, even under an ideal regulatory system the ethics of clinical research will continue to depend significantly on the integrity of investigators. Developing and maintaining professional integrity is a challenging task for physician investigators in view of the inherent ethical complexities of clinical research, coupled with the pressures to enroll patients, complete studies, and publish scientific articles. Of particular concern are the financial incentives for investigators to recruit patients into clinical trials.113 Surgeons should act to limit the effect of economic forces on the patient-physician relationship by minimizing the unavoidable conflicts of interest present in reimbursement mechanisms and by acting as consistent patient advocates.114 Curr Probl Surg, July 2003

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By acting as advocates for patients, surgeons will enhance the stance and strength of the therapeutic relationship. Successful advocacy enhances the surgeon’s power in the patient’s eyes; even unsuccessful advocacy shows the patient that the surgeon is working for him. The foundation of a strong surgeon-patient relationship is the surgeon’s ability to elicit and enhance patient trust. Excellent communication skills, strong clinical and technical abilities, and sound ethical judgment are the crucial elements in facilitating the transfer of trust from patient to surgeon. To enhance patient trust, surgeons must also critically evaluate the outcome of surgical therapy, particularly through patient-reported outcomes research. By embracing this type of research, surgeons demonstrate to their patients a commitment to improving their life and health rather than merely achieving technical successes. Furthermore, with this information, patients are able to make a more fully informed decision about surgical therapy. This attention to the wishes and preferences of patients generally, and to individual patients at the time of decision-making, enhances trust both by showing respect and by valuing their definition of benefit. We must meet the challenges of the current health care environment by focusing on the cornerstone of our practice, the trust that our patients place in us.115 Communication between physicians and patients should be truthful (ie, statements should be in accord with facts). If the facts are uncertain, that uncertainty should be acknowledged. The exception, by stating what is untrue or by omitting known facts should be avoided. These ethical principles cover all research communication. The strong moral obligations of truthfulness and honesty prohibit deception.

Ethics Review Boards

Society, in providing relative autonomy to organized medicine, expects the profession to regulate itself when it comes to the quality of medical care. Physicians as a group not only have the knowledge and expertise to evaluate the care provided by colleagues and to assess the utility of new therapeutic techniques, but also have an obligation to do so for the benefit of their patients. Individual patients also rely on members of the medical profession to ensure an adequate level of skill and judgment among their peers. As part of a peer review process, physicians have a responsibility to assess their colleagues and report those who are incompetent or unethical.116-118 A clinical trial is a scientific study in an area relating to patient care. A good clinical trial must be designed with a clear hypothesis. The question(s) posed by the trial should be asked in such a way that measurable, clear, and quantitative answers would be forthcoming. 390

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Randomized Clinical Trials

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Methods for collecting and analyzing the data should be described in advance. The final results of the trial should be open to full disclosure, be published in peer-reviewed journals, and be reproducible by others. Ethical concerns are always a part of clinical trials. To consider these concerns effectively there must be a full comprehension of the implications of the trial by both health care personnel and subjects.119 Ethics review boards offer a policing methodology to the researcher that should be welcomed by all concerned.

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The randomized clinical trial originated in an era when patient autonomy was less widely respected or encouraged than it is today, reflecting a paternalistic tradition which tolerated some coercion of patients, either for the good of society of for the patient’s own good.120 Randomized clinical trials may interfere with patient autonomy and decision-making. Insistence on evaluation of new therapies by randomized clinical trials often reflects a sincere desire to protect patients from choosing potentially harmful therapies.121 Despite the safeguards of the institutional review boards (IRB) and the informed consent protocol, it is believed that randomized clinical trials may still compromise a patient’s autonomy for 3 reasons. First, different IRBs interpret their mandate differently, and thus, there is enormous variability in IRB decisions. A research protocol that might be approved by one IRB might be rejected by another and an informed consent form regarded as suitable by one IRB may be disqualified by another. Second, even if both arms of a study initially appear truly equivalent to an investigator, a patient’s unique characteristics and values may make 1 option preferable for that person. Patients frequently make choices between alternative clinical therapies even when the best medical data suggest that they are making the wrong choice. Even when therapy has been proven effective, patients may refuse therapy. Our society does not insist that adult patients be required to accept the treatment that is best for them. Our political system defends freedom of choice even more, acknowledging that such freedom may have tragic consequence. Finally, patient autonomy in randomized clinical trials is completely safeguarded only if the patient is free to choose (without agreeing to participate in the randomized clinical trial) any therapy which they might have received by participating in a randomized clinical trial and is equally free to choose a randomization alternative. Patients still should be permitted to make voluntary and uncoerced decisions whether or not to participate in a randomized clinical trial. Careful monitoring of therapy should be available for all patients, and Curr Probl Surg, July 2003

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physicians should learn how to care for patients in ways that take into account the patient’s psychological needs and hopes.122 The ethical problem that should be stated is: when is it ethical to start a trial? The answer must depend a great deal on the context, the clinical condition, the state of the art of various treatments, the speed with which knowledge and technology relevant to the condition and the treatment are evolving, as well as the features and design adequacy of any specific proposed randomized trial. To the extent that a randomized clinical trial truly limits physician or patient autonomy (ie, when the doctor cannot offer nor the patient obtain a particular therapy except through enrolling in a study) this may raise serious questions about unjust restraints on clinical action. But when we remember that harm is done through unnecessary disabling surgical treatments believed to offer great benefit, we must wonder whether individual freedom should always trump valid attempts to gain the most knowledge. Chalmers suggests that in situations of real uncertainty, the physician does a patient a disservice by basing treatment on personal anecdotal experience.123 Instead, the ethically superior course of action is to randomize from the first patient.124 Alternative approaches to treatment based on physician and patient preferences, especially in situations of uncertainty, often produce avoidable bad outcomes. If physicians compare clinical hunches with colleagues, they may discover important differences in attitudes about what constitutes the best treatment. Discussion with peers may help them develop a true sense of which therapies are standard or best for a particular condition.

Special Populations

Certain populations may be at increased risk for exploitation when proposed as subjects in research: those who lack decision-making capacity such as children, the mentally ill, the elderly with cognitive impairments, and those who do not have complete freedom to accept or reject participation in research such as prisoners, those in the military, and patients receiving charity care. Those lacking capacity cannot adequately evaluate the potential risks and benefits and therefore, cannot make ethically valid expressions of their preferences to become or not become research subjects. Captive populations may not have sufficient freedom to make voluntary choices. Although these considerations have validity, our society certainly has not ruled out research, and should not do so, involving these populations. To categorically forbid research on those individuals lacking certain mental capacities would at least diminish, if not preclude, potential progress on disorders afflicting them, perhaps even unique to them. One

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such example, could be the improvement of palliative procedures to reduce discomfort from decubitus ulcers occurring in elderly individuals with senile dementia. Our society has tended to deal with these problems in procedural ways. We allow surrogates to make most decisions about participation in scientific protocols involving individuals without capacity when there appears to be the prospect for benefit for being a subject in a therapeutic project or when the risks appear to be minimal. IRBs have particular obligations for oversight regarding research on vulnerable populations such as children and fetuses.125,126 When we anticipate the possibility of direct benefit, we also need to take care not to exclude these individuals or groups simply because the problem of authorizing the participation is more complex than it is with competent, autonomous individuals. Sensitivity to the dominant values of other cultures should also be an ethical requisite of international collaboration in multi-center trials. Accommodating cultural differences, even in ethnic groups within the pluralistic society of Western nations, will usually require flexibility in procedures rather than the compromise of fundamental principles. The equitable selection of human subjects for participation in clinical trials is one of the criteria for IRB approval according to the code of federal regulations of the United States.127 The recent emphasis on assuring women, ethnic and minority groups, and economically disadvantaged people fair access to clinical trials stems in part from recognition that people often receive better treatment within a clinical trial than in ordinary practice. There is also the concern about the generalizability of clinical trial results if the trial participants are not representative of the disease population for which a treatment on the study is intended. However, concern for equity must be balanced by what is scientifically meaningful and feasible.128 Patients who are not competent to give their consent may be research subjects but only when there is no substantial risk to them and when the knowledge sought cannot be gained from competent persons. Obviously the knowledge sought should be important. In addition, it has been recommended that when research involves children as young as 7 years old, they should be informed of the nature of the research and be given the chance to refuse to participate.129 Potential research subjects should give consent whenever possible. Research on incompetent patients, such as patients with dementia or very young children, seems most justifiable when the results of research from competent or adult subjects will not suffice and where its results may provide a benefit to the patient’s group. In addition, some authorities have recommended that if an incompetent patient shows an objection to the research, he or she should be withdrawn Curr Probl Surg, July 2003

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from the study. When true consent by the subject is not possible, research cannot proceed until another person has consented on his or her behalf. Such a person must have the authority to do so and should consent only to research that concerns conditions directly related to the characteristics of the subject’s patient group. Consent by parents with critically ill children is a sham since they will agree to almost anything that offers their child hope.130 One should still try to ensure that parents in desperate circumstances understand the truly experimental nature of any treatment offered. Patients who are suffering from a potentially life-threatening disease are especially vulnerable, fearful, and subject to influence. Doctors who are enthusiastic about the trial must, therefore, be on their guard against bringing undue pressures to bear on their patients in an effort to persuade them to participate. It must be emphasized that the same problems related to clinical trials also exist in the absence of randomized clinical trials. There is a long catalog of disasters that have followed the enthusiastic introduction of new surgical and medical techniques without the benefit of proper experimental methods.102,131 For that reason when any new treatment is introduced, the first group of patients to receive it must be handled in the same way as patients entering into controlled clinical trials.

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Placebo Surgery in Clinical Trials

Surgical trials clearly do face some unique challenges. The first challenge involves placebos. There are 2 problems here. First, any surgical procedure, even when designed to have a particular effect, in and of itself may exert a powerful placebo effect. The simple fact of having surgery, independent of whether the operation achieved specific aims, may result in symptom relief and functional improvement, as demonstrated by relief of angina from internal mammary artery ligation.132 The second problem with placebos concerns the difficulty in actually giving a placebo operation to a patient. New techniques, especially when endorsed by influential members of the surgical community, stand a good chance of being adopted before their usefulness has been demonstrated adequately. Beecher states, “It is therefore essential for the surgeon to be on his guard lest he deceive himself, and others, in perpetrating costly, dangerous, even fatal operations whose effectiveness is only that of a placebo.”133 Invasive sham treatment remains controversial, although some protocols with IRB approvals continue to employ it. One typically wants a blinded design to avoid the bias that observers (eg, patients, surgeons, other evaluators of outcome) might have based on explicit or unconscious allegiances or antagonisms for some arm or arms of a study. One way to 394

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avoid such bias in the evaluation of the results is to have independent observers who are unaware of how any given patient has been treated. This often can be accomplished using objective, functional outcome measures that do not depend on the precise treatment being revealed in the process of obtaining the information. Blindness is an important strengthening feature and should be used whenever possible. For example, histologic slides, radiographs, or laboratory tests can be interpreted by a physician who is blinded to the patient’s treatment allocation.134 Placebo controlled randomized clinical trials are difficult to conduct, but they are occasionally necessary to determine patients’ benefit in quality of life and survival. If a placebo arm is part of a randomized clinical trial, the ethical justification for its use must be defined carefully. The recent use of sham operations in randomized clinical controlled trials raises 3 critical questions about the research involving human subjects. The first question concerns a tension between the highest standard of research design and a higher standard of ethics.135 When these 2 standards come into conflict and researchers cannot simultaneously meet both, which should prevail, and how should a balance be struck? The second question points to ongoing uncertainties and disagreements in assessing the risks and benefits of research protocols. When reasonable people, the members of well-established members of IRB, or the sponsors of research disagree in their risk-benefit assessments, can one assessment or the other properly be considered the correct one? The third question concerns a relationship between the risks of a protocol and research subjects. Does the requirement of informed consent imply the potential subjects should be permitted to decide what risks they are willing to take in the hope of receiving some benefit? Or do research subjects require protection that may limit their choices? Situations in which scientific standards in research clash with ethical requirements are fortunately quite rare. The use of placebo controls in some types of research remains controversial despite the status of the placebo controlled trial as the gold standard of research design. At first glance, the recent studies involving patients with Parkinson’s disease in which sham operation is used as a control and “real” operation is used to implant fetal cells appeared to fulfill the conditions that would make the placebo controls ethically acceptable.136 Why should the use of sham surgery be questioned when the conditions for the ethical acceptability of a placebo controlled study appear to be met? The chief reason is that performing a surgical procedure has no expected benefit other than a placebo effect and this violates the ethical and regulatory principle that the risk of harm to subjects must be Curr Probl Surg, July 2003

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minimized in the conduct of research. In a standard placebo controlled drug trial, the inert substance used in a placebo is known to have no adverse effects. The potential harm in a placebo controlled drug trial stems from withholding or withdrawing a standard medication that has been proved effective for the treatment of the disorder being studied. The question of how great the risks of sham operation are in any particular trial is distinct from the question of whether a surgical intervention carries risks of harm that are greater than those associated with no surgical intervention. It is undeniable that performing an operation in research subjects that has no potential therapeutic benefit fails to minimize the risk of harm. An alternative research design that did not involve sham operation would pose a lower risk of harm to the subjects in a controlled group of the study. But herein lies the tension between the scientific and ethical standards: the alternative design would be less rigorous from a methodological point of view. The risk of harm in placebo controlled surgical studies is not limited to the morbidity associated with the surgical intervention. In studies employing sham brain operation in patients with Parkinson’s disease, general anesthesia was administered to the subjects in the placebo group. As a result, controversies about both the magnitudes of the potential harm and the risk benefit ratio have surrounded the trials involving sham surgery in patients with Parkinson’s disease. Researchers have an obligation to minimize the risks to their subjects. Is it overly paternalistic to protect research subjects from risks they seem willing to accept? The emphasis today on respect for the autonomy of patients and research subjects creates a reluctance to question whether their choices are fully rational. Studies of consent documents show that they sometimes overstate the benefits and understate the risk of research protocols. Sham operations are ethically unacceptable as a placebo control in trials of fetal cell transplantation in patients with Parkinson’s disease. Sham surgery, with accompanying anesthesia, poses the risk of any surgical intervention that would not be used alone for therapeutic purposes. One question remains to be answered. Those who defend the use of sham operations could argue that the possibility of a strong placebo response to surgery does, in fact, confer a benefit on the subjects who are randomly assigned to the control group. Might the benefits of the placebo effect outweigh the risks of the sham operation and therefore, justify its use in research? The answer is no unless the sham operation would be recommended solely for therapeutic purposes outside the research context. A related question is whether it would be ethical to conduct trials 396

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specifically designed to document the placebo effect of surgery. Three groups would be needed: an untreated control group, a group undergoing sham operation, and a group undergoing “real” operation.137 Johnson argues that for surgical procedures, as for drugs, the placebo effect must always be taken into account if any assessment is to be objective. Yet, despite the importance of the research question, Johnson maintains that none of the means of measuring placebo effects can be applied to surgical operations because it is unethical, for example, to make an abdominal incision and sew it up again without undertaking any procedure. One cannot always predict what the medical community will decide. But one conclusion seems apparent. The placebo-controlled trial may well be the gold standard of research design, but unlike pure gold, it can be tarnished by unethical applications.138

Conclusions

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Scrupulous care must be taken to observe the highest ethical standards in all of our research, be it basic, translational, or applied. Glaring examples of ethical lapses have occurred in the United States with the human radiation experiments and the Tuskegee syphilis studies all representing moral blots on society.139 An advisory committee on human radiation experiments was convened by President Clinton in 1994 in response to allegations of unethical practices in radiation experiments involving human subjects that were sponsored by the U.S. government between 1944 and 1974. The committee’s final report was released in October 1995. Although it focused on human radiation experiments, the advisory committee identified 6 basic ethical principles as particularly relevant to its work: (1) one ought not to treat people as a mere means to the end of others, (2) one ought not to deceive others, (3) one ought not to inflict harm or risk of harm, (4) one ought to promote welfare and prevent harm, (5) one ought to treat people fairly and with equal respect, and (6) one ought to respect the self-determination of others. The committee was unanimous in its views that scientists of the future must maintain a clear understanding of their duties to human subjects and the clear expectation that their leaders of their fields value good ethics as much as they do good science.140 Edmund Pellegrino, a noted medical ethicist, states that “the concept of the good of the patient must remain the final criteria of whether a decision is morally sound.”141,142 He emphasizes the following principles, which we must continue to keep in mind: (1) protect the vulnerable, powerless, easily exploitable patient, (2) be true to the ideal of the 2500 year old Hippocratic oath, (3) weigh the possible risks and benefits to the patient, (4) consider the impact of the Curr Probl Surg, July 2003

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patient’s illness on the family unit, (5) remember that medicine is a moral enterprise, and (6) remain aware always of the primacy of the patient’s well being.

Ethical Aspects of Research and Commercial Uses of Tissues and Organs

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There are many important uses for human tissues and organs removed from people in the course of managing their disorders and diseases as well as biological materials specifically donated for other reasons. These biological materials (sperm, urine, blood, tissue, etc.) are useful for transplantations, for basic research, and for commercial applications. Sometimes the applications involve treatments, whereas at other times they involve diagnostic tools.143 There are several ethical concerns involved with these materials because of how they are obtained and how they are used. Several ethical concerns associated with tissues and organs used in transplantation will be addressed in the upcoming section on “Allocation of Health Care Resources.” This section will examine ethical issues associated with the use of biological materials for research, especially research having commercial aspects. This section will not address concerns of storage of biological materials for use by the military, by law enforcement, for reproductive purposes, and for other uses.144-147 In general, a logic of altruism governs the way in which biological materials are obtained from human beings for the purposes of research and commercial development. Patients and normal subjects donate their biological materials without the expectation of payment or future remuneration. Because these materials are not useful to the donors themselves (or are in fact positively harmful), they turn them over to researchers who may make some contribution to medical progress through basic research or treatments. If there is any “payback” at all for donors, it is in the form of compensation, not payment. Compensation is generally considered to consist of a modest amount of money or goods given in consideration of the time and effort involved in donating biological samples. Sometimes, however, the difference between compensation and payment can appear vanishingly small. For example, compensation to human egg donors can sometimes run into the tens of thousands of dollars. In cases like this, what starts as a mechanism of compensation starts to look more and more like outright payment. It is not surprising that the blurry lines between compensation and payment in cases like ova and sperm donation have parallels in ways other biological materials are obtained, including even diseased organs and tissues removed to protect the health of patients. In the past, most 398

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tissues and organs were, of course, excised without consideration of value for research or commerce. If this material was useful at all, it was useful for pathological and epidemiological studies. The vast majority of such biological material amounted to (and this is hardly an overstatement) biological waste. Because of advances in research and the promise of commercial profit, there has been something of a sea-change in regard to the potential uses of tissues, organs, and sometimes even whole bodies. Blood, tissues, and organs can be of enormous interest to researchers and corporations alike. Barry Eisenstein, MD, Vice President for Science and Technology at the Beth Israel Deaconess Medical Center in Boston has said, “the value of patients’ tissues has potentially gone up enormously.”148 Biological materials are now collected under the watchful eye of researchers interested in basic science advances and commercial gain. Because of the increased value of some biological materials several commentators have started to call into question the logic of altruism that governs donation. Commenting on the general expectation that donors receive no payment for their biological materials, Robert Cook-Deegan, MD, of the National Academy of Sciences has said that “we have a system where the research participants are treated as pure altruists, but everyone else is treated as a pure capitalist. I don’t think that’s quite fair.”148 To put this another way, the perception that researchers use biological materials for their own personal gain (to the exclusion of the donors) cuts against the motives of altruism that underlie many decisions to donate those biological materials in the first place. An editorial in Nature put the matter this way: “In the past, the prospect of novel treatment resulting from a better understanding of disease has generally been seen as a sufficient reward. This formula is no longer sufficient, chiefly because it does not provide any mechanisms for ensuring that other potential benefits are made available to the contributors.”149 The goal of this section is to describe the debate about giving the donors of biological materials something more than compensation for their time and effort. At the present time the logic of altruism is enshrined in the law, but there are many ways in which researchers can still improve the relationship with donors to avoid the felt sense of injustice that researchers are making windfall profits on the backs of hapless donors. It remains to be seen whether certain ethical arguments raised in favor of giving donors something more than compensation will be persuasive and prevail in the democratic process that governs law and policy in this area. Curr Probl Surg, July 2003

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One case from the courts has, more than any other in this area, framed the discussion of whether and to what extent people may expect to receive payment for materials taken from them in the course of their medical care and that are subsequently used to produce commercially valuable profits. This case is widely known as the John Moore case.150 Because the case took place in California, its legal force is, strictly speaking, limited to that jurisdiction. Other cases in other jurisdictions may unfold in different ways. Whereas it is unclear that this case will be the last word on the topic, the case nevertheless carries considerable significance in the debate about payment and compensation. In 1976, Dr David Golde began treating John Moore for hairy cell leukemia at the University of California at Los Angeles (UCLA) Medical Center. To treat this condition, the physician removed Moore’s spleen after obtaining a signed consent form for the operation. The physician apparently made arrangements before the operation to have portions of the spleen retained for research.151 The consent form, however, made no mention of this and, with Moore’s signature, authorized the hospital only to dispose of any tissue by cremation.152 The physician and the University continued to ask Moore to return to Los Angeles from Seattle where he lived for follow-up examinations. He made more than 12 such trips between 1976 and 1983, many of them at his own expense. When it became a burden for Moore to pay for these trips himself, the researcher paid his expenses. During these examinations, Moore was apparently told various samplings of blood were necessary for monitoring his health. In fact, Moore’s cell lines produced unique lymphokines in quantity. This amount of usually scarce substances made their isolation possible. Moore’s physician went on to use the cell lines and biological products as the basis for patent applications and contracts with 2 corporate sponsors, in exchange for a large payment to the University and stock options for himself. Only in April 1983 was Moore was given a consent form to authorize research on his biological materials. Moore signed the document, but it made no mention of commercial development. In September 1983, Moore was given a consent form to authorize the use of his blood for research and granted UCLA the rights to cell lines and potential products developed from materials taken from him. Moore said that vague answers to his questions made him suspicious about the purpose of the form, and he specifically excluded the medical center from obtaining rights to cell lines or products developed from his biological materials. Dr Golde made 400

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several subsequent attempts to secure this consent. In 1984, however, Moore learned about a patent that had been issued on the basis of his biological materials and that others were pending. He filed suit against several parties involved in the research and the University. Moore was mightily offended. He said that Dr Golde and his University employer “had made every effort to translate the medical and scientific value of my blood cell properties into private commercial gain and personal financial profit, again, without my knowledge, consent or participation.”152 Moore went on to say that on the basis of Golde’s “representations that my care and my health were at stake, that I consent to the activities which made his personal commercial and research activities possible!” Moore noted, to ironic effect, that Dr Golde’s materials and discoveries played no role in treating his actual medical condition. In the course of his testimony, Moore claimed damages on 2 fronts: failure to obtain informed consent and wrongful use of materials over which he had proprietary interests. In regard to informed consent, Moore said “... I believe it is consistent with the human values inherent in our system of laws that we require that patients be informed by their physicians or by researchers when they are known to possess unique biological and/or genetic characteristics which can lead to breakthroughs in medicine or science.” In regard to the use of biological materials from him, Moore said “I also believe that physicians should not abuse the position of trust and confidence which they establish with their patients to obtain economic advantage unfairly gained at their patient’s expense, nor to deprive their patients of economic opportunities or of their individual and property rights merely because they are that patient’s physician. I believe those property rights extend not only to biological materials of unique or special value but also to the genetic structures and sequences which, as we now know, are the ultimate source of those materials and of our individuality as people.” Moore claimed an economic stake in the materials: “I further believe that, especially in situations in which the physician has acquired knowledge which would lead him to believe that a profitable exploitation of these unique materials is possible or likely, the physician owes the patient the duty to inform him of those possibilities, and to provide that patient with the opportunity to share in the uses to be made of those materials and any commercial benefits or personal profits that physician will gain thereby.” For all his outrage and effort, Moore’s case ultimately failed in court. His first attempt was turned away on preliminary motion, but the California Court of Appeal did find that Moore retained a proprietary Curr Probl Surg, July 2003

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interest in his tissues and could proceed with his lawsuit. On further appeal, the Supreme Court of California ruled, however, that Moore had no proprietary interest in his removed cells. That court did say he could try to show in court that Dr Golde had breached certain fiduciary obligations of informed consent. On the main contention, however, that he had a property interest in these materials and that they had been wrongfully appropriated without his knowledge or consent, Moore’s case failed. This decision left Dr Golde and the patent holders with full control over the disposition, use, and profits of these biological materials. It is unclear from the published literature what the exact value of those biological materials was. However, it is clear that both UCLA and Dr Golde gained considerable financial advantage from both payments from pharmaceutical companies and stock options.151 The California Supreme Court issued its opinion through 2 opinions for the majority and 2 opinions from the minority in dissent. One commentator has observed that these 4 opinions do not share the same notion of property law or how it applies to the human body.151 In its majority opinion, the court specifically went out of its way to say that acknowledging a property interest for donors would slow down research by wiping out economic incentives for researchers. The court also pointed out that acknowledging a property interest could mire researchers in lawsuits. “The extension of conversion law into this area will hinder research by restricting access to the necessary raw materials. Thousands of human cell lines already exist in tissue repositories... These repositories respond to tens of thousands of requests for samples annually... At present, human cell lines are routinely copied and distributed to other researchers for experimental purposes, usually free of charge. This exchange of scientific materials, which still is relatively free and efficient, will surely be compromised if each cell sample becomes the potential subject matter of a lawsuit.”150 In a strongly argued dissent, by contrast, Justice Broussard argued that human biological materials are market goods and that there is, therefore, no reason not to recognize the patient’s economic interest in materials coming from him. More to the point, he argued that property rights could be fashioned in such a way that would allow donors such as Moore the ability to participate in the economic value of their tissues without impeding research and development leading to new pharmaceutical products. After all, he sardonically noted, the majority opinion in the case recognizes property rights to these biological materials, it is just that they restrict them to the researcher and the pharmaceutical companies, not to Moore.151 402

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Some commentators have agreed with the California Supreme Court. Physician and bioethicist Robert Levine has argued that there is little reason to start making arrangements for payment to donors of biological materials. He argues that after people abandon human material to advance their own personal good—through urination as much as through a splenectomy (eg, they loose all interest in the material except privacy). He has said that materials removed from patients for their own well being “... should be seen as passing into the public domain...”152 The only caveat is that these materials should not be used in ways that threaten the interests of the patient. To make this point, Levine noted that “to learn the structure of adrenocorticotropic hormone (ACTH), Dr Aaron Lerner and his colleagues had to first purify the hormone. This required taking the pituitary gland from approximately 7000 dead human beings. Are their estates,” he asked, “entitled to a share in the proceeds?” He has also gone on to say: “the average number of patients participating in phase I–III drug studies is about 3000. They all give their blood, their urine, and much more to participate in such development. Are they entitled to an opportunity to negotiate for their share of the market?” Other commentators have also raised these same kinds of concern, maintaining that a market in tissue/cell research works against the development of an energetic biotech industry.153,154 When it comes to thinking through what arrangements would look like if donors did in fact receive payment for their biological materials, Levine notes that potential donors are usually at a serious disadvantage when it comes to such negotiations. A great deal of research does not require specific individuals or specific biological samples. For the most part, tissues and organs are highly replaceable; even if there were to be negotiations about their compensation for their biological materials, the sheer number of potential donors would keep values very low. This kind of scenario is in fact more than hypothetical. A case involving exactly this kind of negotiation fell through when a family found that researchers would not meet their demands for genetic samples. In 2000, the Beth Israel Deaconess Hospital in Boston turned away research subjects who were said to have asked for compensation far above that normally given to research participants.155 In this case, researchers had approached a particular family because of their longevity. The family members had long life spans, and a gerontologist thought these people might possess a gene predisposing to long life. It would be of keen scientific interest and perhaps of significant commercial gain to identify such a gene. The medical center declined to meet the family’s demands for payment, however: “The center denied their request and, to date, this Curr Probl Surg, July 2003

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research has not been conducted.”155 That said, one official acknowledged that the Medical Center might have come to a different conclusion about compensation had there been an advocacy group that could have made more effective demands than a single family was able to do.148 In justifying its decision, a representative of the medical center did acknowledge the legitimacy of compensating donors, but said that compensation was restricted to matters of time and inconvenience. Officials also said that they were uncomfortable paying this family while other families were donating their tissues free of charge.148 The justification of this decision also invoked the notion of tissue donation as an altruistic gift to society. The authors of the public justification of this decision also raised concern about providing inappropriate incentives in particular settings, wanting to avoid the possibility of coercion. The authors also pointed out that payment for blood has produced the undesirable result that, compared with blood obtained without monetary compensation, the process leads to unwanted and unusable blood. Lastly, the authors cited as precedent for their decision the case of John Moore. They endorsed the view that entering into arrangements over and above compensation could interfere with downstream commercial development. In response to this set of justifications, some commentators argued that excluding donors altogether from any potential commercial gain might increase mistrust of medical researchers.156 In other words, the perception that researchers can achieve windfall profits to the exclusion of the donors of unique tissues may undercut the donors’ willingness to donate. These commentators also noted that worries about coercion could be kept under control by ensuring an appropriate scale between the compensation and the donors’ situations. For example, some commentators have proposed paying research subjects for their involvement, and they have argued that because of the low-skill effort involved that payment should be on the order of a minimum wage.156 Although this kind of payment scale would not satisfy all parties who wanted to capitalize on their donated materials, it could nevertheless silence the criticism that donors are completely excluded from any economic gain made through research on their biological materials. It has also been pointed out that although there is a high hepatitis infection rate of blood obtained with payments rather than donation it is unclear that compensation would produce unusable and pathogenic tissue samples across all domains of medical research: “tissue samples from patients with particular disorders or genetic 404

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markers are not as ubiquitous as blood and are not as easily retrieved. Compensation might even work to boost supplies.”156 Certainly it would be very undesirable to negotiate individual contracts about payment with each and every donor of biological materials, especially if many of those donors were in fact dead and one had to negotiate with estates. However, with reasoning similar to that of Justice Broussard, it should be asked whether compensation must always interfere with downstream commercial development. For example, donors of tissue might be given some flat fee (the exact amount might be linked to the expectation of commercial benefit) and asked to sign a waiver of all future claims.157 It is also possible that the researchers might tie payment to actual commercial success. In other words, the researchers might not make any kind of payment to the parties whose biological materials are used unless there is some kind of financial profit. And the payment need not even go to the donor. The researcher could, for example, route payment to organizations designated by the donors. For example, some donors might designate the American Cancer Society or the American Foundation for AIDS Research as recipients should the researcher actually obtain some measure of commercial success with a new biological product. In ways such as these donor altruism would be rewarded and respected, without crippling innovation in biomedical research. To say that some compensation might be given to the donors of biological materials is not to say that this compensation should be high or that it must necessarily be dictated by a single formula. Compensation could be governed by several principles. One way to decide how much to compensate donors would be to turn the matter over to the market. “Donors” could sell their biological materials for whatever price they wished. If they had rare traits of interest to researchers, they could presumably hold out for higher compensation than if they had common traits. Other than that, researchers might offer a take-it-or-leave it flat fee or, compensation might be tied to actual financial profits. And in all cases, the compensation might go to a charity or nonprofit organization designated by the source of the biological materials. These schemes of compensation are speculative at present. Consideration of these options would become more urgent if the political or legal landscape were to change in any significant way.

Informed Consent for Research Uses of Biological Materials It is a cornerstone of research ethics that researchers should involve human participants only with their informed consent, unless certain exceptions apply. The post-World War II Nuremberg Code is explicit on this point: “the voluntary consent of the human subject is absolutely Curr Probl Surg, July 2003

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essential.”158 This ethical imperative was formulated in a context, however, that was primarily concerned with persons, not with pathological tissues removed from persons and with donated materials such as tissue, blood, skin, and gametes. It is not always clear how standards put in place to govern research on persons should be interpreted in terms of research on biological materials. By the estimates of the National Bioethics Advisory Commission (N.B.A.C.), there may be as many as 300 million stored human tissue samples in the United States.159 It is hard to know how many samples there might be worldwide, but the figure will certainly be enormous. Even if researchers are fully prepared to observe strict standards of consent, it remains true that many biological samples may have been banked under conditions that did not take into account future uses. In addition, therefore, to the question of what donors of biological materials should be told in the present day, there is also the vexing question of what standard of consent to apply to materials banked in the past but only now of research interest. In one view, it might be argued that no research should be conducted on tissues except that to which the subject has specifically consented. This strict approach is unattractive for the reason that biological materials banked in the past become of interest to researchers for reasons that were unforeseeable at the time of the original sampling and storage. For example, researchers found blood samples banked in the 1960s and 1970s particularly useful for tracking the emergence of HIV infection in the 1980s. It could be argued on a strict interpretation of consent that this material should not be available for research because, at the time of the donation, nothing was known about HIV, and testing for this disease could not have been predicted. It is for reasons like these that researchers may wish to obtain blanket consent to research uses of the samples. However, some ethical difficulties do emerge with this approach. For example, the privacy of the research subjects may be invaded in ways that could not have been imagined at the time of the original consent. As an example, testing biological specimens for HIV 10 years after the original sampling and banking could expose individuals to a kind of unwanted consequence that might have (if it had been known at the time) led the donor to reject the agreement. To afford researchers broad access to stored biological materials and to protect donors at the same time, the N.B.A.C. has recommended that consent be waived for studies of banked biological materials if the research does not involve greater than minimal risk. The Code of Federal Regulations defines minimal risk: to mean “that the probability and magnitude of harm or discomfort anticipated in the research are not 406

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greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”160 It is, of course, a matter of debate about what exactly this may mean in a particular environment or for a particular group of subjects. If the risks of the research do exceed the threshold of minimal risk, the N.B.A.C. has recommended that consent be obtained from the original donors. As an example of how this might work, in the 1990s researchers wanted to study samples of breast tissue banked before the identification of BRCA genes. Obviously, the women in the original study could not have consented to the study of a genetic condition not known at the time their tissue samples were taken. Obtaining consent from all the donors would be laborious and some of the women might be impossible or locate or even have died. On the other hand, there could be risks to the original donors if their predisposition to breast cancer became known to parties in a position to curtail employment, insurance, etc. In this particular case, the researchers advised the original subjects, as best they could locate them, of the genetic study, advised them of the risks of genetic studies, and allowed them to opt out. Moreover, the samples were anonymized before being analyzed. Along with other groups, the N.B.A.C. has called for greater attention to the informed consent process in regard to the banking and use of biological materials. At the very least, people should be advised that their biological materials may be used for research and commercial development and given the option to decide against such uses. As a matter of law, this was one of the key lessons of the John Moore case. Therefore, the N.B.A.C. identified several ways in which the consent process could be improved. For example, the Commission recommends that IRBs require researchers to provide a description of the process by which biological materials will be obtained. They also recommend that “when informed consent to the research of human biological materials is required, it should be obtained separately from informed consent to clinical procedures.”159 In clinical settings, researchers should also make clear that refusal to consent to these research purposes will not jeopardize patients’ clinical care. One of the more interesting recommendations from the Commission is that the informed consent process should provide potential subjects with enough options to help them understand their decision clearly. For example, the informed consent mechanism should make it plain that subjects could: (1) refuse any role in research, (2) permit unidentified or unlinked uses of their biological materials, (3) permit certain research but Curr Probl Surg, July 2003

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accept or decline future contacts about consent to further studies, (4) permit research only in specific studies, (5) permit coded use of biological materials in all future studies, and so on.159 These recommendations do not have the force of policy or law, but they provide an interesting benchmark by which to evaluate the way in which donors should be apprised about research and commercial uses of biological materials. The focus on informed consent brings with it certain cautions, too. Although there has been some study about the way in which research subjects understand the research options offered to them (ie, the informed consent process) this field is far from well-studied.161 More study is certainly warranted to examine how the way in which information is presented shapes decisions that donors make. It is one thing for researchers to understand the importance of informed consent; it is another thing to appreciate the ways in which that process actually goes forward and shapes decisions to donate. It should also be mentioned that there have been several proposals about ways in which biological samples could be stored to make samples available while protecting donors at the same time. One proposal has been made to establish “tissue trustees” whose primary purpose would be to allow researchers access to biological samples of interest while at the same time observing standards that would protect donors from any loss of rights.155 Another proposal has involved setting up repositories as legal trusts. Legal trusts confer duties on their trustees to protect the interests of those involved with the trust while working toward the stated goal of the trust.162 The establishment of repositories along these lines could go a long way toward ensuring high standards of informed consent and release of materials in ways that protects donors.

The Relationship between Researcher and the Public From a certain perspective, the use of biological materials excised in the course of medical treatment may look like nothing more than the salvaging of some value from what would otherwise be incinerated. The use of these materials in research might even be viewed as a social activity of the highest importance. Research with these materials contributes to new techniques for the treatment of disease and disorders. Even the importance of biomedical research does not, however, permit the relaxation of ethical concerns about how biological materials are obtained and used. As the Moore case has made clear, the role of physician and researcher can sometimes come into conflict. It is an abiding ethical concern that researchers, especially physicians, do not compromise a subject’s inter-

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ests for reasons related to the needs of the research or to the researcher’s financial gain. In the worst cases, this conflict can lead to deception, poor medical treatment, and a coarsening of attitudes toward patients. There is no doubt that informed consent is essential in maintaining good relationships between physician-researchers and their subjects. That said, considerable empirical study will be necessary to ensure that subjects do understand their options in regard to the disposition of biological materials and that they in fact exercise them in ways that are meaningful to their core values. Good informed consent procedures will not, however, by themselves resolve the debate about returning some degree of economic benefit to the donors of the biological materials necessary to research and commercial development. Good informed consent may prevent donors from having inaccurate expectations, but they may still feel offended at being excluded from profits gained by researchers. One of the worst uses of medical ethics is to identify possible horrible outcomes of any proposed course of action and to use those possibilities as a way of vetoing proposal. It is a legitimate worry that involving the people who are the sources of biological materials in commercial arrangements will impede the swift advance of biomedical research. This would be especially true, for example, if donors were involved in every intimate detail of the research options and if subjects could negotiate individual contracts with researchers about what they required as remuneration for their samples. Nevertheless, it is an open question whether the status quo works for or against a relationship of reciprocity between donors of biological materials and the researchers who profit from them. Bioethicist Thomas Murray has noted that we mostly think and act as if our organs and tissues are gifts. The assertion of property rights and increasing commercialization of biological materials undercuts this view. What he worries about especially is an issue of perception: “if the public perceives that scientists are taking advantage of people who have made such gifts, their sense of justice will be offended, and they will expect some kind of restitution.”152 The elaboration of consent forms will only provide short-term resolution, he thinks, to more basic questions of social justice. He has said further that “since the gift [of tissues and organs] was originally given in the spirit of public service, some part of the profits should be returned to a similar goal. In addition, the person should be justly compensated.” At the present time, there is no obvious political movement afoot to restructure the consensus that people should donate their biological materials to researchers for altruistic reasons and without expectation of economic benefit. That said, there does seem to be increased ethical sensitivity to the Curr Probl Surg, July 2003

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matter, which in time may turn into a political consensus. The larger ethical issue at stake here is what sorts of relationships we want to have with one another and in what kind of communities do we want to live. Do we want to have “donors” systematically excluded from any kind of economic benefit achieved through biomedical research using their biological materials? Do we accept the view that some researchers using these materials may achieve windfall profits? Do we accept that the current system does enough to dignify the givers of biological materials? Or is it important to return some economic value to donors to avoid a sense of their alienation from the research process? As this set of questions makes clear, much more debate and discussion is necessary to find the way to protect researchers from undue regulatory burdens while at the same time affirming for all subjects the meaning and value of participation in biomedical research.

Allocation of Health Care Resources

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Policies of just access to and financing of health care, together with the strategies of efficiency in health care institutions, dwarf in social importance every other issue considered in this book.

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The book referred to in the above statement is Principles of Biomedical Ethics (5th ed) by Beauchamp and Childress and the quotation occurs near the end of their comprehensive chapter on health care allocation and justice.163 Although issues of health care allocation do not initially have the same appeal as some of the other traditional areas of biomedical ethics (such as informed consent, end-of-life issues, and confidentiality), they represent some of the most basic ethical issues facing society within the context of health care. Issues of health care allocation, moreover, have taken on an increasing importance as health care costs increase disproportionately to other societal costs. Health care is driven by expensive technologies and the costs associated with its provision are staggering. In 1965 health care costs in the United States totaled approximately $1 billion and in 1993 they were approximately $750 billion, an increase of 75,000%.164 Even if that chocolate bar which cost 5 cents in 1965 now costs $1, that is still only an increase of 20-fold, compared with a 750-fold increase in health care expenditures. These increases are explained by 2 developments: the advent of new expensive technologies and the explosion in medical knowledge. In the 1960s, for example, there was really not much one could offer a woman with breast cancer other than a mastectomy and close follow-up. In 2002, the options for women with breast cancer are breathtaking: mammo410

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graphic screening, various biopsy modalities, breast-preserving surgery, radiotherapy, chemotherapy, sentinel node sampling, reconstructive surgery, hormone suppression, and more. Although there have always been limitations to the amount society will spend on health care, as our costly diagnostic and treatment modalities proliferate, decisions must be made with respect to how to allocate resources. Allocation of health care resources is about much more than money. It is also about issues of justice, equality, freedom, and autonomy. An in-depth examination of resource allocation in health care explores issues such as whether there is a right to health care, whether there should be a basic minimum of health care for each individual in society, whether individuals should be responsible for their health, how should health care be funded, and how to fairly distribute our limited resources.164 Ultimately, a discussion of resource allocation in health care requires consideration of the basic issues of justice. It is important to distinguish macroallocation from microallocation. Macroallocation refers to decisions, often at the federal or state level, regarding how much of our common resources should be allocated to health care versus, say, education or security. The decisions regarding budgets for Medicare and Medicaid, for example, are issues of macroallocation, as are decisions regarding how much to invest in research and how much in clinical care. Although decisions of macroallocation are often made at by state and federal agencies, private foundations and health insurance companies may also make them. Microallocation refers to the allocation of resources within the health care system. It is often construed on an individual level, but it may be quite broad. It may involve decisions about whether to fund more preventative care or more acute care. Should money be put into treating heart disease or into neonatal care? There are many levels of microallocation, right down to the level of the hospital where administrators may decide to allocate more money to intensive care and less to ambulatory care. There is even a level on which physicians participate in microallocation, since they make decisions all the time as to whether a test or treatment is worthwhile or not. Although they might not want to acknowledge it, physicians and nurses, especially those working in HMOs, make decisions of microallocation all the time. The distinction between macro- and microallocation is necessarily somewhat gray and exactly where macro- becomes microallocation is hard to say. Nonetheless, the terms are useful and employed regularly in discussion of health care resources. One additional issue should be clarified: private versus public health care. When discussing resource allocation in the context of health care, Curr Probl Surg, July 2003

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we often presume that most of these decisions are made by government agencies for programs such as Medicare and Medicaid. In the United States, however, the majority of health care expenditures (60%) occur privately, through health insurance. In this situation, the allocation of health care resources occurs through the free market and is determined primarily by the ability of individuals to pay. In countries such as Canada, in contrast, there is minimal private health care and the government as a single payer makes the vast majority of health expenditures. The private versus public health care issue illuminates many aspects of health care allocation. The concept of “justice” plays an important role in considerations of resource allocation. Part of the problem with a discussion of the term “justice” is the fact that it has different meanings in different contexts. Within the criminal justice system, for example, it refers to the meting out of appropriate punishment for people who break the law. Within the business community, justice represents the attempt to provide fair procedures and permit fair competition. Within the area of education, justice refers to impartial evaluation of academic performance. With respect to health care allocation, justice implies the fair and equitable distribution of health care resources among those entitled to them. It is often referred to as “distributive justice” in this context. In its larger sense, distributive justice refers to the fair and equitable distribution of most societal goods including political rights, responsibilities, and social and economic goods. For example, the grounding of individual rights is a matter of distributive justice, as is the fair collecting of taxes or the requirement for military duty. A theory of distributive justice, for example, will attempt to justify and provide a foundation for many of the various rights which most of us take for granted in our society, such as the right to associate freely, to free speech, to education, to express our opinions, to vote, and to religious belief. It will also try to provide a basis for the fair allocation of our common resources, such as parks, roads, air, water, and our social services. There are many different theories of distributive justice which attempt to ground or anchor what is felt to be the fair distribution of rights and benefits in society. Some authorities emphasize personal freedom and autonomy and others emphasize more equality among members (more typical of Canadian or British society). Regardless, there are several principles that are central to most theories of distributive justice. These are often referred to as material principles Table 2. No society or theory is based exclusively on 1 of these principles to define justice. Instead, it is a matter of balancing the various principles, 412

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TABLE 2. Principles central to theories of distributive justice 1) 2) 3) 4) 5) 6)

To To To To To To

each each each each each each

an equal share. according to need. according to free market. according to social contributioin. according to effort. according to merit.163

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although there may be a primary emphasis on 1 or 2 of them. One can see immediately how these principles might inform various ideologies. For example, ‘to each an equal share’ was clearly the defining principle in the ideology of the old Soviet Union, at least with respect to economic goods. In the United States, of course, merit and free market principles are more prominent. This is not to suggest, however, that the principle of equal share is not important in the United States, because there is a strongly held conviction there that all members of society should have equal civil and political rights. Although there are many different theories of distributive justice, there are 3 classic ones that we will discuss briefly here: (1) egalitarian, (2) utilitarian, and (3) libertarian.

An egalitarian theory of justice stresses an equal distribution of benefits and burdens in society. This does not mean simply that all members should have the same income, drive the same vehicles, and get the same education. Instead, it means that there should be a “fair equality of opportunity.” The most prominent advocate of this theory is John Rawls, whose book A Theory of Justice has had enormous influence over the past 30 years. Rawls’s argument, in short, starts out by recognizing that all individuals in society are subject to 2 sets of forces which confer advantage and disadvantage on them: the natural and social lotteries. The natural lottery refers to personal characteristics or qualities of an individual, which provide him with advantage or disadvantage through no merit or fault of his own. Height and good hand-eye coordination, for example, may be attributes, which confer advantage on an individual in regard to being a successful basketball or baseball player. With respect to health, it refers to the luck of having been born with what we colloquially call “good genes.” Losers at this lottery may develop diabetes, heart disease, cancer, multiple sclerosis, arthritis, etc. Losing at the natural lottery, needless to say, can have devastating consequences on one’s life. The social lottery refers to those social circumstances that are conferred Curr Probl Surg, July 2003

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on us by good or bad luck, such as wealth, social status, or educational opportunity. Just being born in a time when there is no war represents good luck in the social lottery. The influence of the social lottery is equally profound. Someone of only modest abilities who is born into social circumstances that provide great opportunity may become very successful and wealthy. Others, who may have considerable personal ability, but fewer social resources, may not be as successful. In relation to health, we can easily appreciate how someone’s health would be promoted or affected adversely by social circumstances. Recognizing the arbitrariness of these lotteries, Rawls argues that a just society is one which would distribute most of its benefits and burdens among its constituents to optimize the equality of opportunity. In essence, he argues that life may not be fair, but a just society strives to make it fairer by attempting to minimize the advantages and disadvantages of the natural and social lotteries. In so doing a just society strives to establish equality of opportunity, by removing or minimizing barriers to opportunity. Norman Daniels has been the primary proponent of Rawlsian theory in the area of health care allocation. He does not simply argue that health care resources should be equally distributed among members of society, but rather they should be distributed in such a way as to optimize equal opportunity.165,166 There are clearly situations when some persons may warrant a larger piece of the health care pie to achieve equal opportunity. This view regards disease (and an individual’s lack of resources to treat it) as an unfair barrier to opportunity in society. Daniels is a strong proponent, therefore, of a minimum adequate health care coverage for all citizens and he argues that the goal of social institutions dealing with health care should be to allocate resources in such a manner as to establish equal opportunity. This ‘equality of opportunity’ view might explain why we often are inclined to give preference to children over the elderly when it comes to allocating our health care resources. We intuitively sense that the elderly have already had most of their opportunities and children are in a position where they have many of their opportunities ahead of them. With respect to the material principles mentioned above, we can see that the egalitarian theory includes several of them. ‘Equal share’ plays a role in the attempt to provide an equal share of opportunity. The principle of ‘to each according to need’ is also included, since persons who are arbitrarily disadvantaged by the natural and social lotteries (ie, are in need) are recognized as needing extra resources to achieve equal and fair opportunity. The Rawlsian theory also acknowledges merit and effort, in that it not only establishes a level playing field, but allows those who work 414

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harder, who achieve more, to excel and benefit from it. Of course, purists might argue that the ability to work hard and make a concerted effort are qualities that are unfairly conferred by the natural or social lotteries and that those who are ‘lazy’ should be given resources to help overcome their laziness. But, of course, when it comes to human behavior, the question of where personal responsibility begins and arbitrary luck ends is a thorny issue.

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Utilitarianism owes its most classic formulation to John Stuart Mill in his short volume Utilitarianism. Utilitarians argue that justice can and should be achieved by general application of the principle of utility that states: Actions are right in proportion as they tend to promote happiness; wrong as they tend to produce the reverse of happiness.

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In short, an action or practice is right or good in utilitarianism if it tries to maximize the good and minimize the bad. It is sometimes summarized as the “greatest good for the greatest number.” It is ultimately a theory of consequentialism; that is, the moral value of an action or practice is determined primarily by the consequences of that action. The utilitarian believes, for example, that stealing and lying are generally wrong because they have a negative effect on the overall happiness of society with only a minimal good impact on the persons who do the stealing and lying. It is important to point out that the utilitarian does not think stealing or lying is wrong because there is something intrinsically wrong about these activities. This allows the utilitarian to justify stealing or lying in certain cases for the greater good. Imagine that an evil genius is working on building a nuclear bomb and you have the opportunity to steal the plans. According to the utilitarian, there would be little difficulty justifying your action. Of course, there are lots of examples where actions have both good and bad effects. The building of a new stadium or highway may be good for the community at large, but be devastating for the few who lose their homes or livelihoods as a result. In the case of health care, utilitarians believe that justice is served by allocating resources in society to maximize good and minimize the amount of suffering. This initially seems like a pretty common-sense approach to allocating resources. But the problem for the utilitarian, of course, is to figure out a way to value the various goods and bads. In other words, utilitarians must somehow quantify the interests of the various parties and weigh them accordingly. How much suffering by how many people does it take to balance the good of building a new highway? Or, within a medical context, how much and how many people should suffer during the experimental phase of a new Curr Probl Surg, July 2003

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drug to justify its good in the future. Although we may feel comfortable stealing from an evil genius, would we be willing to sacrifice the lives of a dozen children to produce a vaccine that would help millions? Although there is much more to say about utilitarianism, it is rarely endorsed as an exclusive theory of justice, although its principles and ideas have been influential.

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Libertarianism is often held up as the antithesis of egalitarianism. It places respect for individual freedom, autonomy, and private property as its primary ideals. Libertarians reject the egalitarian view that justice requires the redistribution of wealth based on need or bad luck in life’s lotteries. They place a premium on individual freedom and believe that health care is best left to free market forces. The primary role of government in this situation is to ensure that the procedures of competition are fair, but it should have no role in trying to achieve equal distribution of wealth, resources, or opportunities. Taxation and the redistribution of wealth, according to a strict libertarian, are coercive and infringe on the rights of citizens to freely choose what to do with their wealth. This is not to say that in a libertarian’s world it is only survival of the fittest, but rather that they place their emphasis on freedom and autonomy. From a health care perspective, this means that health insurance should, for the most part, be private and purchased voluntarily by citizens. A strict libertarian would reject programs such as Medicare and Medicaid and argue that maximal justice and efficiency is achieved by letting the market determine how health care is allocated. There are several objections to the libertarian view. First, on prima facie grounds, it seems simply unfair that people without the natural or social resources should be without any supplemental help. Second, many authorities argue that overall wealth in society is not simply the sum of individual wealth; instead, it is a communal product and even if an individual did not specifically contribute, for example, to Bill Gates’ wealth, society as a whole did. Third, health care, as in many other economic arenas, does not always follow simple economic rules such as supply and demand. Health care demand is elastic (ie, if you build the beds, they will come). Moreover, health care is a necessity. But unlike other necessities such as food, water, and shelter, the need for health care is often unpredictable and potentially catastrophic. As one author writes: “No one wakes up needing $10,000 worth of food.” But it is not unusual to wake up needing $10,000 in medical care.

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United States versus Canada in Health Care: A Contrast in Justice

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No country embraces one theory of justice exclusively. Many countries represent a comingling of various concepts and theories. However, it is clear that individual societies or countries have different accents. In the United States, for example, there is a strong tradition of libertarianism, which protects the rights of individuals and champions individual freedom. It is not surprising to see that individuals and businesses, therefore, privately purchase the majority of health care insurance in America. It is also not surprising to learn that some members of society, without adequate natural or social advantages, are unable to obtain insurance. At the same time, the United States has a long history of egalitarianism and has demonstrated this emphasis in programs like Medicare and Medicaid. These ostensibly contradictory forces are not really at odds with one another. They represent the varied forces in a diverse and multifarious society. On the topic of universal access to health and the provision of basic health care to all members of society, there are many legislators and citizens in the United States who believe it is the right thing to do. In fact, the 1983 “Presidents Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research” concluded that there should be an “adequate” level of health care provided to all members of society. Indeed, that was an important plank of the Clinton platform in the 1992 election. There are many who believe that the United States would have a universal access health care system today, were it not for the disproportionate lobbying power of various interests groups, notably the health insurance industry, professional medical organizations, and the like.167 In contrast to the United States, Canada has implemented a single payer universal health care system. It is administered by the various provinces and territories with legislative supervision from the federal government. It is not linked to employment or the ability to pay in any way. Regardless of age, wealth, or social status, every Canadian has equal health insurance, funded the same way. Canadians have unlimited hospital, physician, and ancillary service coverage and there are few extra costs. There are no copayments and the entire system is funded primarily through tax revenues. These qualities of the Canadian system highlight some of the significant advantages of a central single payer system. It is clearly more efficient and cost-effective. A single payer system has considerably fewer adminCurr Probl Surg, July 2003

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istrative costs. There are none of the expensive utilization management issues which private insurance carries out, such as preauthorizing care and limiting coverage. There is also less duplication and less waste. Since there is no competition between insurance plans, there is little money spent on marketing and sales. And there is no bureaucracy needed to screen out ‘high risk’ individuals. Everyone is covered, equally and comprehensively. The single payer system is also more circumspect about the adoption of new, expensive technologies until they have been shown to be effective. There is also a competitive benefit to Canadian business, since business is not responsible for providing health insurance. The proof of this greater efficiency is evident in the fact that Canada, which provides comprehensive health care coverage for 100% of its citizens, spends approximately 10% of its GDP on health care-related services, whereas in the United States, this amount is 13.6% and there remains 15% of the population without any health care insurance and another 15% to 20% who are significantly underinsured.168 Indeed, compared with every other developed country that has a universal public health care system, the percent of GDP spent on health care is significantly lower than in the United States [eg, Germany (8.7%), Japan (6.9%), France (9.4%), U.K. (7.1%), Netherlands (8.6%), Sweden (7.9%)]. According to the Organization for Economic Cooperation and Development, in 1995 the United States spent 80% more per capita on health care than Canada.169 These advantages come at a price to Canadians, however. To make the system work, Canadians tolerate considerable restriction on their liberties. They pay higher taxes and appear to wait in line more. They are also prohibited from purchasing most health care privately. The small private health insurance industry in Canada is only allowed to provide coverage for services which are not covered by their provincial health care plans (which, in effect, is almost nothing). It is prohibited in Canada to charge a patient directly for health services, which are provided by the provincial health plan. It is also against the law for an individual to purchase health care which is provided by the provincial health care plans. Regardless of how wealthy a Canadian might be, he cannot seek out a doctor and pay him to fix his hernia or bypass his blocked coronary arteries. Nobody is supposed to jump the queue. All such services are administered exclusively through the provincial health care plan and fairness dictates that everyone is treated equally, regardless of economic or social status. In theory, whether one is Bill Gates or is living below the poverty line, he is supposed to be treated equally. This is theory, of course, and in reality money and status have influence in Canada, as they do everywhere. An in-depth contrast between the Canadian and American health care 418

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systems is not feasible here. The point of this contrast is not to praise or recommend 1 system over the other, but rather to point out some of the obvious differences in each system and highlight the differing conceptions of justice. Both health care systems have advantages and disadvantages and both systems represent, in part, the respective approaches to justice in each country. All 3 theories of justice have pros and cons. They all contain elements that correspond to our intuitive beliefs about justice and fairness. This short description of them helps to clarify some of the issues which play a role and will come to light when we discuss transplantation and rationing.

Transplantation

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Organ transplantation touches on perhaps more issues in biomedical ethics than any other area of medicine. Here, we focus on the issues of resource allocation involved in transplantation. There are 2 main issues of resource allocation involved in organ transplantation. First there is the issue of economic resources. Although many aspects of health care are costly, organ transplantation is uniquely expensive and resource intensive. Not only are there the costs involved in the actual operation, such as retrieval of the organ from the donor (often requiring a separate surgical team and a private jet to transport the organ) and the transplantation into the recipient, there are also the extensive preoperative and postoperative ongoing costs associated transplantation. Around most transplantation programs there is a huge network of supporting services, including social work, psychology, rehabilitation, and others, which enable the entire program to function. In the United States, a liver transplant exceeds $300,000 in resources in the first year of care alone, assuming there are no significant complications, such as rejection requiring repeat transplant.170 Cardiac and lung transplants are almost as costly. Although kidney transplantation is less expensive (approximately $100,000 per transplant) it is considerably more frequent. Regardless, in 1996 the estimated cost for all solid organ transplants in the United States was $3.06 billion to care for 19,366 individuals. This works out to approximately $158,000 per transplant. This sum is remarkable when one considers that the per capita amount spent on health care is one fiftieth as much ($3000 per year).170 Because of the extreme expense of transplantation, and the relatively few who individuals benefit from it, the argument is often made that money would be better put into areas where one gets more ‘bang for the buck.’ How many millions of people could benefit if that money were Curr Probl Surg, July 2003

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used to improve education or basic health? From a utilitarian point of view, organ transplantation can be difficult to justify, since it burdens a great many financially and benefits only a few. Of course, those it does help are helped enormously. Transplantation is in some ways comparable to the U.S. space program. It is very costly and its overall benefits to society are debatable, but it represents unique, cutting-edge scientific development at the extreme of our abilities. Its real benefit to society may lie in the psychological boost it gives society. Furthermore, the decision to fund transplantation (like the space program) has never been purely economic, but rather strongly political. The second issue of resource allocation in organ transplantation is the unique problem of how to fairly distribute the organs. In addition to its exceptional expense, transplantation is unique because it deals in organs— commodities that are termed absolutely scarce. Livers, kidneys, lungs, and hearts are absolutely scarce resources (ie, the number of available organs cannot be increased no matter how much money is spent or invested). Parenthetically, blood is actually the most commonly transplanted organ, but because it is effectively a renewable resource and its procurement is relatively benign it is not included when speaking of organ transplantation. This is why we often refer to “solid” organ transplantation when discussing the topic. In contrast to kidney failure, where dialysis can prolong life indefinitely, there is no comparable temporizing measure for liver, lung, and most heart disease. In the case of liver disease, when an individual’s liver fails, either he gets a new liver or he dies. Because the number of individuals waiting for a liver transplant at any given time is greater than the number of livers becoming available, it is a fact of liver transplantation that some people will die because they cannot get a liver. This is also the case for heart and lung disease.

Fairness in Allocation of Organs Before 1984 there were no specific laws in the United States governing transplantation and allocation of organs. A transplant center could choose to perform a transplant in whomever they wanted, using whatever criteria was felt to be appropriate. In the early 1980s the heart transplant program at Stanford University, for example, had a policy that precluded people with a history of alcoholism, unreliable employment, antisocial behavior, and psychiatric illness from receiving a heart transplant. There was also no compromise on the cost and their policy effectively precluded people without significant economic resources. Because of these and other allocation problems surrounding organ transplantation, Congress in the United States passed the National Organ Transplant Act in 1984. This Act

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legislated efficiency and equity in organ allocation. Shortly thereafter, the United Network for Organ Sharing (UNOS) was designated as the body that would administrate the donation, matching, and allocation of all organs. UNOS is a private, nonprofit charitable organization, to which every transplant program, Organ Procurement Organization (OPO), and tissue-typing laboratory in the United States must belong. Every single transplant in the United States is administered through UNOS and UNOS is responsible not only for matching organs, but for creating transplantation policy. With respect to organ allocation, UNOS has decided that only medical criteria should play a role in the way organs are allocated. UNOS has complex formulae, of which severity of illness (ie, need), time on the waiting list, and probability of successful outcome are the key criteria. The category of ‘probability of successful outcome’ includes several prognostic factors such as blood and tissue type, organ size, and the distance between donor and recipient (cold ischemia time). There are other factors that play a role, such as whether an individual has already had a transplant and the likelihood of finding a suitable donor in the future. In any given year, there will be approximately 3 times as many people waiting for an organ compared with the number of people who will receive one. For example, there are approximately 4,500 liver and 12,000 kidney transplants performed annually and there will be approximately 13,000 and 42,000 people on the waiting lists, respectively. Patient suitability and compliance is also considered a relevant factor in transplantation. Patients will not be accepted into a program unless they demonstrate the ability to be compliant with the treatment and have social supports in place. Although this may appear to be a nonmedical criterion, compliance and support affect the likelihood of success and are, therefore, considered medically relevant. It is occasionally perceived as bias against people with vices (eg, alcoholics) or poor social background (ie, criminals). The most obvious example of this is the requirement on the part of liver transplant programs that individuals considered for transplant must be abstinent from alcohol for at least 6 months or longer. Notably missing from the allocation formula is age and individual responsibility for disease. In a country that allows the wealthy to purchase almost anything, it is a notable exception that one cannot purchase an organ or influence the organ transplant waiting list in the United States. No matter how wealthy you are, how well-connected you are, how famous you are, according to the UNOS guidelines, you are not allowed to influence the allocation process. Curr Probl Surg, July 2003

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Personal Responsibility and Organ Transplantation

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Because of the acute shortage of organs, some degree of rationing must occur. One recent and controversial approach to rationing is to consider personal responsibility for disease as a criterion in the way we allocate organs. Although there are many examples, such as smoking and lung disease or cocaine/drug use and heart failure, the most written about and discussed is the question of whether individuals with alcohol-related liver disease (ARLD) should have the same access to a new liver as a patient whose liver failure is in no way related to personal behavior or practices. For the initial 20 years of liver transplant surgery after Starzl did the first transplant in 1963, it was felt that alcoholics were unsuitable because of poor prognosis and high recidivism rates. Since the early 1980s, however, there have been a series of studies which show that transplantation for ARLD is associated with comparable success rates and, moreover, very low recidivism rates. Since 1985, there has been general consensus that patients with alcoholic cirrhosis can be candidates for transplantation if they meet certain minimal criteria, such as abstinence for at least 6 months, a sincere acknowledgment of their disease, and a desire to maintain sobriety and undergo rehabilitation.171,172 Most centers have a patient compliance agreement, which, if broken, can result in loss of eligibility for transplantation. In 1990, the Health Care Financing Administration, the body which establishes the coverage for Medicare in the United States, recommended that “coverage for liver transplantation be offered to patients with alcoholic cirrhosis who are abstinent.”171 There are several arguments presented for considering alcoholics a lower priority for transplantation. From a distributive justice point of view, which emphasizes equality of opportunity, patients with ARLD have had 1 normal liver that they damaged by their own activity and as a result they have used up their opportunity. On the other hand, an individual with sclerosing cholangitis, whose disease is not related to any personal activity, has not had that opportunity and has a better claim to a liver. In other words, if one construes the Federal transplant allocation program as a form of health insurance, it is unfair to ask members of a health risk pool to indemnify others for a cost that they could have avoided. This, of course, presumes that alcoholism is a voluntary behavior, which could be stopped by the individual. Although this topic is large enough to fill a separate volume, as a society we generally hold alcoholics responsible for their behavior. For one, we hold drunk drivers culpable as well as criminals who commit crimes such as rape while under the influence. Second, transplant programs insist on a minimum

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period of abstinence before acceptance into a program, indicating the fact that drinking must be voluntary to some extent. They do not ask of patients with other forms of liver disease that they halt the progression of their disease to be considered for transplantation. Even organizations like Alcoholics Anonymous demand as the first step that people acknowledge responsibility for their disease. Because of these unique circumstances, several authors have argued that there is good reason to give patients with ARLD lower priority on transplant lists.172-175 Veatch, for example, while arguing from a distributive justice point of view, takes this position.173 He points out that no matter how one regards the disease “alcoholism,” the individual must bear some responsibility for the results: ...alcoholism [is] a complex phenomenon with some causal factors well beyond the control of the alcoholic. At the same time....to preserve their dignity as human agents, alcoholics must be viewed as significantly responsible for their behavior, that there is a voluntary element in it.173

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He concludes that suitable candidates for transplantation who have ARLD should still be considered for transplantation, but that they should be given a modest decreased priority in the allocation process. At a minimum, he argues, a history of alcoholism should be a “tiebreaker” for situations in which 2 candidates appear to have equal claim for an organ. Whether one agrees with Veatch’s view or not, the point of this review is to demonstrate how we might take into account individual responsibility for a disease.

Foreign Nationals and Other Moral Problems in Organ Allocation The issue of foreign nationals underscores the distinction between economic cost and absolute scarcity of the organ. Wealthy business people from developing countries may come to the United States and have no trouble paying cash for a transplant. But the issue is: should they get the organ? At present, UNOS allows transplant centers to carry out 5% of their transplants on foreign nationals. It is a question of justice to ask whether the wealthy businessman from, say, Indonesia should get access to a national resource such as a liver. Clearly other factors (especially economic) play a role. Transplant centers are limited in what they can charge Americans, but foreign nationals can be charged whatever the market will take. It would not be surprising to learn that a foreign national pays over a $1 million for a liver transplant. At the same time, however, one can argue that it is unfair to preclude foreign nationals who come from developing countries that do not have the resources for transplantation. Another allocation dilemma is whether people who represent the more

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unpleasant side of society such as convicts, should have equal access. Should a convicted rapist or child molester have the same claim to an organ as a mother of 3 young children? Do people forfeit their right to equality under the UNOS criteria if they break the laws? If so, what about people who don’t break the law, but are of dubious value (eg, mobsters, prostitutes)? What about people who make important social contributions to society, such as a minister or an important politician? Should social contribution play a role? The answer to this, according to the UNOS, is a definite “no.” What about people themselves who are not willing to donate their organs in the event they suffer a premature death? Should they have access to a liver? Or should only people willing to share in the provision of the resources have access to the pool? The countries of the European community, for example, participate in an organ-sharing network. However, some countries were recently dropped from the network because of low rates of organ donation. The rationale was that because they did not contribute their fair share to the common pool, their citizens were ineligible to access this pool.176

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To some extent the entire topic of resource allocation is really just the topic of rationing and priority setting. But what exactly is rationing and how it is performed are questions that are filled with misconceptions. Rationing means a “conscious policy of equitably distributing needed resources in limited supply.”167,177 It is important to clarify that rationing of health care resources is nothing new, whether in the United States or elsewhere. We may not like to think that decisions about who has access to care or who receives life-saving treatment occur in our societies. But since all societies have always had and always will have finite resources, some degree of rationing must occur. As Victor Fuchs says: “the United States has always rationed health care...[N]o nation can provide ‘presidential medicine’ for all its citizens.” When we think of rationing health care, most people think of programs like Medicare and Medicaid. Such programs have limited funding and as the demand increases and technology costs skyrocket, decisions about what forms of treatment and who gets them must be made. Both Medicare and Medicaid have specific criteria for coverage and this represents rationing according to need (determined, ultimately, by income level, disability, or age). They also limit to some extent the amount and type of care they will provide. One of the most original and comprehensive 424

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attempts to implement fair rationing is the Oregon Medicaid Plan of the late 1980s. What most people do not realize is that in the United States most rationing occurs implicitly, almost silently, within the free market system. Rationing occurs either through an individual’s or an employer’s ability to pay for insurance or actual treatment. It also occurs within the insurance industry itself, which is illustrated by the extensive bureaucracy associated with preauthorization and utilization management. Insurance companies are rationing. They do so every day, based on what they have determined is appropriate treatment of medical conditions and how much money they are willing to spend. They will not, for example, pay for a colonoscopy, unless they feel that the indications to do so are appropriate. One unfortunate outcome of this form of rationing is the fact that individuals with genetic, familial, or congenital health problems may not be able to obtain adequate coverage, even if they have the financial resources to purchase insurance. Many people do not appreciate that Health Maintenance Organizations (HMOs), often seen as the scourge of modern health care in America, are at their basis just rationing structures—mechanisms designed to keep health care costs under control.178 In the case of a socialized health care system, such as in Canada’s, much rationing is explicit, although rarely appreciated by its citizens. And although it may ultimately be fiscal in origin, much rationing in Canada occurs in the form of commodity scarcity (ie, limited beds, physicians, CT scanners, etc.). It may occur on a federal or provincial level, when the government decides what services are covered by the health care plans. For example, treatment for infertility is not usually covered whereas treatments such as birth control (ie, tubal ligation) and therapeutic abortion are insured services. Rationing in Canada may also be on the basis that a town or community simply does not have a local hospital. But much rationing also occurs within hospitals. Because most hospitals in Canada receive a global annual budget, hospitals must occasionally limit the amount of service they can provide, or otherwise run a deficit. This approach occasionally limits the number of elective operations, forces closing of beds, or delays updating technologies. Given that rationing of health care is ubiquitous, regardless of what health care system is at play, the question which arises is: are there criteria or principles of rationing that we can apply throughout society and which are fair to as many people as possible? There is a large amount of information written on this topic, but for the purposes of this discussion, we will concentrate on 2 examples: age-based rationing and cost-effective rationing as in the Oregon Medicaid Plan. Curr Probl Surg, July 2003

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Age-Based Rationing

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Many authorities have suggested that it is not unreasonable to weight health care rationing according to age. We are all familiar with the statistics that the majority of health care expenditures appear to occur during the final year of life, usually in the elderly. If we were to limit the amount spent on the elderly and resist the attempt to prolong life, but simply minimize suffering, we would save considerable amounts with no expense of justice. Moreover, with the presence of Medicare in the United States, seniors already receive substantial rationing subsidies. A well-known example of age-based rationing occurred in the United Kingdom, where for many years dialysis was withheld from people over age 55. There is also an implicit rationing in much organ transplantation. Not many 75 year olds will receive a new kidney or heart, even if their prognosis is good. There is also an explict policy in the United States favoring younger individuals with respect to kidney transplantation. Patients under 18 years are given various advantages as well as extra points in the allocation formula.163 There are several arguments to support rationing based on age. First, in general, one can argue that age is an independent prognostic factor for most diseases and treatments. Older people generally do not fare as well and if the prognosis is an important factor, then age should play a role. Second, if one employs the criteria of quality-adjusted life-years (QALY), one might argue that the elderly will get less benefit because they will not live as long after the intervention. A 20 year old patient with cardiac surgery may live 50 more years whereas a 75 year old patient might live only another 10 years. Other arguments in favor of age-based rationing are rooted in theories of justice. Daniels argues that prudent individuals would “choose... to distribute health care over a lifetime in a way that improved our chances of attaining a normal life span” and we would therefore reject the notion that the vast majority of our health care resources be spent in the final days of our lives.163 Other authorities argue that if we conceive of life as a baseball game, then everyone is entitled to the same number of innings. Once you have had your 9 innings, everything else is “gravy.” But for those who have not had their share of innings, they warrant extra resources to achieve them. In this argument, 1 inning might represent 7.5 years. From an equality of opportunity point of view, we might similarly argue that the goal of justice is to provide as many people as possible with the opportunity to live a normal life span and not spend disproportionate amounts on people who have already achieved a normal life span.

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One of the primary justifications of age-based rationing is that it does not unfairly discriminate, as would rationing based on race, wealth, etc. Everyone has equal opportunity, since nobody is born at 65 years of age. However, there are many objections to rationing on the basis of age. First, there is no proof that withholding expensive interventions would be any cheaper than providing basic supportive care. For example, it may be cheaper to remove the colon cancer in an 85 year old patient and have him live another 5 years relatively pain free, than to withhold surgery and have him suffer miserably for 2 years using up expensive support services. Second, rationing explicitly on the basis of age may have significant social costs, such as animosity between age groups, stereotyping of age groups, and more. It may be easy to imagine withheld health care services as a faceless statistic, but it may be significantly more difficult if it is your own parents or grandparents. Third, as Beauchamp and Childress point out, the elderly might argue with considerable force that the advances in technologies and treatments were made on the basis of their tax dollars and their hard work. Finally, unless such a form of aged based rationing were applied uniformly throughout society, those with wealth would easily be able to get what they need and ultimately such a policy would discriminate on the basis of wealth in old age. A formal policy of ageist rationing is generally distasteful to most members of democratic developed societies. It is hard to imagine how a formal age-rationing policy would look. The notion of withholding health care from a World War II veteran, who fought for our freedom, would be hard to swallow. To some extent there is a certain amount of natural implicit rationing which occurs, based on prognostic issues and just the fact that many elderly individuals recognize that quality is more important than quantity. What the discussion about age-based rationing does, however, is highlight the myriad of problems associated with any formal, systematic rationing scheme.

The Oregon Plan: CEA, QALYs, and Common Sense The Oregon Medicaid Plan represents 1 of the first and most comprehensive attempts to ration health care systematically and fairly in the United States. In the face of increasing costs and what appeared to be arbitrary and inconsistent application of the Medicaid rules, the Oregon state legislature passed the Basic Health Services Act in 1989. This Act established a Health Services Commission to “develop...a priority list of health services, ranging from the most important to the least important for the entire population to be served.”179 The impetus behind the Oregon plan was to provide all citizens living below the poverty line with a basic, Curr Probl Surg, July 2003

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adequate amount of health care coverage. This plan would only apply to people who are eligible for Medicaid. But the plan also accounted for escalating expenditures. Because Medicaid was on a fixed budget, the rationing would take place based on the rank-list of services it would provide. In other words, based on the priority ranking of the Health Services Committee, Oregon would provide funding for the services on the list, starting from highest to lowest priority, until all the funds were exhausted. At some point there would be a cut-off line below which services would not be covered. To some extent, this plan was an attempt to promote strong egalitarianism, since it did not change anyone’s eligibility for Medicaid, and provided everyone eligible with equal access to services. It would be bad luck if you suffered from an ailment that was not on the covered list, but it was not necessarily unfair. The trick, of course, was to establish a list which was equitable and fair. Cost-effectiveness analysis (CEA) was the initial principle that would determine the rankings on this list.180 CEA is a method which quantitatively measures costs and benefits associated with various services and, therefore, allows comparisons between various disparate health care services. CEA would provide a way to compare the costs and benefits of, say, yearly pap smears with regular ophthalmologic exams, or liver transplantation with treatment of ear infections, based on the overall cost and effectiveness to society. In some ways, CEA is the utilitarian’s tool to try to maximize the good in society that a certain amount of money will bring. In essence, CEA was supposed to be a methodology to determine which services gave the most ‘bang for your buck.’ The common unit of measurement in CEA analysis was called a quality-adjusted life-year (QALY). A QALY was an attempt to measure the quality of a person’s life for 1 year. If you cured a person of cancer and they lived 5 more years relatively free of disability, this would count as 5 QALYs. If you cured a person of a troublesome back ache, this might add a QALY of 0.25 per year. Oregonians were subsequently surveyed with respect to various ailments to get a sense of what significance various diseases had and the commission tabulated the results. If you are vaguely repulsed by such a crude method of quantifying human life, you are not alone. All stakeholders considered the initial list of 1600 medical procedures and interventions as a complete failure. The bizarre results of the ranking are well known. Capping a tooth and splinting someone for temporomandibular joint pain were ranked higher than surgery for appendicitis in the original ranking scheme. After acknowledging that CEA was far too crude a methodology, the authors 428

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subsequently tossed out the original list and sought further input from stakeholders. The revised list was divided into categories of care, such as maternity care, life-threatening illnesses, preventive care and each category was ranked according to its value to individuals, to society, and whether it was deemed medically necessary. A final list, according to categories, was created and obvious misplacements were considered individually by the commission. The list contained 709 services. It was implemented in 1994. The subsequent history of the Oregon Medicaid Program is interesting, but not relevant to our present discussion about rationing. The Oregon Medicaid Plan helped partially to elucidate some of the major problems with attempting to ration health care. Although we may be tempted to measure health as we do other commodities, such as widgets, customers, or dues, we instinctively sense that there is something about health and illness that resists simple quantitative summarization. In the same way we find it awkward to measure love, religion, and freedom objectively, health and suffering are not really amenable to numerical quantification. True, we can measure the number of people treated and lives prolonged by a particular intervention, but we cannot really measure the significance of what each of these lives mean and what would have been had we not done so. The effect of treating 10 people with arthritis probably has 10 different results. To ask how many hip operations equal one liver transplant starts to sound like the old question of how many angels can dance on the tip of a pin. The initiative to put a value on treating appendicitis, such that we can compare it to the benefit of providing palliative care for a terminal cancer patient is, in retrospect, crude. Although the original CEA of the Oregon plan represented a valiant attempt to understand and implement justice logically, in the final analysis, it appeared to lose the qualities which any such approach and theory must have: common sense and reasonableness. In this regard it is reminiscent of Jonathan Swift’s satirical essay, “A Modest Proposal,” in which he suggests that an optimal way to deal with the burden of children of the poor in Ireland is to use them as a source of food, thereby relieving famine as well as decreasing the number of mouths to feed.181 The Oregon plan also exemplified another misconception about health care allocation. It made decisions of health care allocation appear unrealistically stark, unrealistically black and white. The metaphor on which it was based was one of people lined up to enter a movie theater. When all the seats are full, entry is stopped and those in line are left outside. The truth is that health care allocation decisions are rarely, if Curr Probl Surg, July 2003

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ever, this stark. There are always gray areas, and health care budgets, as with most budgets, always have a degree of elasticity. Moreover, it does not take into account the fact that there are people with tenacity and energy who will push and pull the system. Despite the many problems raised by the Oregon plan, it still provoked many important questions about health care and allocation. It helped further the discussion of what constitutes an adequate level of health care and how we should make these decisions. Although the original scheme for the plan turned out to be a great mistake, like many great experiments much was learned from its failure.

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Although almost all rationing is ultimately economic in origin (except for a few select scenarios such as organ transplantation), we can say that rationing actually occurs in 3 different ways. First, there is what we might call natural rationing, which occurs when access to health care goods are limited by financial or other economic means. This occurs when people do not have the resources to purchase the health care or insurance for it. The forces at play in this type of rationing are natural and greatly influenced by one’s luck at the natural and social lotteries. This is 1 of the primary forms of rationing in United States. Second, there is what we might call commercial or insurable rationing. This is rationing at the level of the insurance industry. It represents decisions such as whether and how to provide coverage for various services and whether to provide coverage for specific individuals. Although it is fiscal at its base, the forces governing this type of rationing are a combination of how to appease the participants in the insurance plan while maximizing efficiency and fiscal responsibility. This is the form of rationing that goes on in HMOs and insurance policies. Its primary force is to try to satisfy the customer. The final way that rationing occurs is what we might call social or governmental rationing. This is rationing which occurs usually through government agencies, and is manifested by decisions of not just how much to put into programs like Medicaid and Medicare, but what specific coverage such programs should provide. Most countries with a social health care system, such as Canada, utilize this type of rationing. Although fiscal considerations are never far away, the force informing this type of rationing is primarily justice. It represents an attempt to maximize fairness on the part of society. Economic efficiency and satisfying the most customers is not the primary goal of this type of rationing. It represents the attempt to mete out justice in rationing, despite all the constraining forces which governments face. This classification of ration-

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ing may have some weaknesses, but it represents 1 way to try to understand the issue and how it plays out in society. As we indicated above, any discussion about health care allocation is ultimately just a discussion about rationing.

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The discussion above regarding justice, transplantation, and rationing highlights the significance of the opening quotation of this chapter. Issues of health care allocation are among the most significant and complicated issues in contemporary medical bioethics. The forces which inform health care allocation are diverse and often difficult to discern. A full discussion of the topic demands knowledge of economic, political, and ethical issues. The topic is vast, unruly, and highly politically charged. Nonetheless, the matters at stake are profound and go to the heart of what we consider a just society. Health care is not like many other commodities in society. Whether everyone should have a right to a television or a car may be an interesting debate, but whether everyone should have a right to adequate health care is a fundamentally more important question. However we wish to allocate health care resources, whether it is by a free market system in the United States or by a socialized system such as Canada’s, it is important to distinguish between outcomes that are unfortunate but not necessarily unfair. The American conception of justice in health care emphasizes liberty and merit, and manifests this through a primarily free market, private property approach to health care. If, for example, an individual has a family history of a genetic disease, such as Huntington’s chorea, and is unable to obtain health care coverage as a result, this is certainly unfortunate, but not necessarily unfair. It is the nature of a strongly libertarian conception of justice. In Canada, where there is a more egalitarian bent manifested in a socialized health care system (and hence, limited budgets), if an individual cannot get timely heart surgery and dies while waiting, because a decision has been made to put extra resources into immunizations or neonatal care, this is also unfortunate, but not unfair. The Canadian conception of justice is at work here. With respect to health care allocation, regardless of the country and the system of justice that is at play, there will always be limits to what coverage is possible. Some decisions and consequences will not be particularly pleasant. Some may be downright unfortunate. But as Tristam Engelhardt says: To live with circumstances we must acknowledge as unfortunate but not unfair is the destiny of finite men and women who have neither the financial nor moral resources of gods and goddesses.182

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Ethical Issues in Surgical Education and Training Ethical Issues in Educating Surgeons

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Any consideration of ethical issues in surgery is incomplete without attention to the ethical issues central to surgical education and training. This topic covers 2 interrelated issues: (1) the moral behavior of surgical residents and surgeons; and (2) the teaching of ethical issues to surgical residents. Although much of the writing in medical ethics that focuses on education addresses the second category, when considering ethics in surgical education, one must consider the first category as well. Little is known about the moral development of individuals during a surgical residency. It is clear that ethical issues are not commonly addressed explicitly during residencies. In fact, many surgical residents express discomfort in addressing ethical issues in patient care.183 Nevertheless, whether surgical residents advance in their thinking and acting according to moral norms is unknown. Several philosophers have suggested that all people move through stages of moral development as they age and mature.184,185 When tests of moral development have been administered to medical students, most students either fail to advance in moral development or else show declines during medical school.186 Regardless of the weaknesses that one might see with research such as this, one can scarcely doubt that medical school is unlikely to make a moral person out of an immoral one. By the time one has graduated from medical school and entered a surgical residency, one’s moral character is already well established. Therefore, if one goal of surgical residencies is to train moral surgeons, there must be careful attention to selecting moral persons to enter surgical residencies. Unfortunately, if it is true that medical students do not advance in moral development, then the complexities of considering morality in the selection process must also extend to the medical school admissions process. Moving beyond the selection process, how should unethical behaviors, so-called moral lapses, be addressed in a surgical residency? This is a difficult question to answer. If a psychological problem is identified in a resident, a program director might mandate that the resident undergo psychological counseling to treat the problem. In contrast, when a moral lapse is identified, there is no “ethical therapy” that can be prescribed to “cure” the immoral resident. In fact, it is often difficult to get faculty to agree on what exactly would constitute the moral or ethical standards of a residency program. Despite these difficulties in addressing moral problems exhibited by 432

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residents, surgical residencies do have some responsibilities to the residents for fostering moral behavior. Although surgical faculty may not reasonably be expected to teach a resident right from wrong, the faculty should be expected to encourage residents to do those things that the residents already know are right. The importance of moral and ethical issues in surgical programs is not a new one. In his sociological study of medical error in surgical residency programs entitled Forgive and Remember, Charles Bosk identified 4 potential errors that residents can commit.187 Technical errors occur when the surgeon is performing a role conscientiously, but his or her skills fall short of what the task requires. For example, if a resident breaks the suture when ligating a blood vessel, a technical error has been committed. Judgmental errors occur when an incorrect strategy of treatment is chosen. For example, if a resident chooses to administer anticoagulants to a patient immediately after a thyroidectomy and a neck hematoma develops, he has committed a judgmental error. The third category of errors, normative errors, occur when a surgeon has, in the eyes of others, failed to discharge his role obligations conscientiously. In other words, if a resident has lied about a patient’s physical examination, she has violated a norm or standard of behavior that considers lying to be immoral. It is within this third category that moral and ethical concerns or problems are placed. Bosk identifies a fourth category of errors, the quasi-normative errors. Quasi-normative errors are breaches of standards of performance that are physician-specific. For example, if a surgeon always closes the skin with a particular suture material and the resident ignores that dictum and closes with a different suture, the surgical resident has committed a quasi-normative error. In other words, such behavior is considered an error for only that particular surgeon who closes in a particular way. Although technical and judgmental errors are certainly significant, these tend to raise fewer concerns among surgical educators because residency programs are designed to teach residents how to avoid these errors. In fact, surgical textbooks are written primarily to help surgeons understand diseases so that judgmental and technical errors can be minimized. Normative errors, on the other hand, are particularly problematic in that they are often less readily identified and more difficult to avoid. When a normative error has occurred, Bosk has correctly argued that a double error has occurred.187 Not only have standards of clinical care been breached when a normative error occurs, but the ethical standards governing the interactions of doctors and patients have also been breached. As such, it is critical to the success of surgical training Curr Probl Surg, July 2003

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programs that such errors are identified and attempts made to ensure that a pattern of such errors do not continue. Despite attempts to minimize normative errors, situations will unfortunately still arise when a surgical resident behaves in a manner that goes outside the acceptable ethical norms. Certainly a single instance of immoral behavior does not make an immoral person. Yet, repeated such moral lapses may be indicative of serious character flaws. Part of the reason for the difficulty with changing moral character is that it is impossible to define a complete set of ethical norms that will be acceptable to all. What, then, can be reasonably expected of a residency program? Certainly, faculty must ensure that residents understand that standards of ethical behavior exist and are to be taken seriously. Such standards of behavior are best set by the faculty of individual residency programs based on societal norms and made explicit to residents. Programs must ensure that the faculty act according to these moral norms and thereby provide appropriate role modeling behavior. Faculty must point out problems to residents when they occur so that repeated moral lapses are not ignored. To meet this responsibility, faculty must be in close communication about resident behavior. Everybody involved must realize that a moral lapse does not make an immoral person. Whenever possible, faculty should provide residents opportunities for explicit attention to ethical standards either through case discussions or formal conferences. Because of the responsibility to society that surgical residencies have, if a resident is not able to act according to moral norms, the resident should not be allowed to complete the residency program successfully. Faculty of individual programs must carefully identify what are acceptable norms for behavior. These norms should then be attended to by each individual faculty member so that residents have the opportunity to see these behaviors in action. When residents are not able to abide by these norms, the faculty must be clear to point out the problems to the resident. Faculty should communicate freely among one another to ensure that repeated small infractions which might identify a disturbing pattern of behavior are not ignored. Although an immoral action does not make an immoral person, when repeated infractions are made, surgical faculty must take seriously their responsibility to protect the public from immoral practitioners of surgery. Ultimately, decisions to fire a resident who cannot act in a moral and ethical fashion must be made. Although difficult, such decisions can only be performed if careful evaluation and documentation has been undertaken. 434

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All surgical faculty must ensure that residents understand that despite the problems inherent in clearly defining norms, standards of ethical behavior do exist. The faculty should strive to provide opportunities for explicit attention to ethical standards whenever possible. Because of the significant responsibility that residency programs have to society, if a resident has a consistent pattern of disregard for moral norms despite efforts to change behavior, the resident should not be allowed to finish a residency program successfully. The moral standards of surgical practice must be upheld by taking immoral actions seriously. Although a surgical residency cannot make a moral person out of an immoral one, programs can encourage ethical behavior and discourage the opposite. Surgical educators must take this responsibility to society and to the profession seriously.

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The Accreditation Council for Graduate Medical Education (ACGME) has endorsed the importance of addressing the ethical issues in medical practice by stating that residents must show competency in the domain of professionalism and ethics. It will not be enough to say that residents witnessed thoughtful doctors making good decisions in conjunction with their patients. Residents will be expected to demonstrate their competency in professionalism and ethics. Exactly how one can demonstrate such competency is unclear. However, there is no question but that more attention must be directed to these issues in the future. Commentators have sometimes debated whether professionalism and ethics are completely overlapping terms. Rather than using these terms as synonyms, it is helpful to consider them as complementary topics. A central issue in professionalism is treating others with respect. “Professionalism” as a concept applies, therefore, to respectful interactions with a physician’s peers as well as with patients. Much of what is generally considered to be mainstream medical ethics is related to the issue of treating patients with respect. For example, the doctrine of informed consent can be derived from the importance of respecting the patient’s wishes. The ACGME has gone beyond this focus only on patients, however, and included a broader set of issues that has roots in Thomas Percival’s concepts of “etiquette.”188 Residents are expected to respect their peers in addition to their patients to exhibit professionalism. This extension beyond the narrow physician-patient relationship, broadens the focus to include the physician’s relationships with others who may be caring for the patient. Especially in the modern team-oriented approach to illness, this concept of professionalism is a welcome addition to some of Curr Probl Surg, July 2003

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the narrow issues in medical ethics that have previously attracted so much attention.

Challenges to Teaching Ethics to Contemporary Surgical Residents

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As contemporary surgical residents strive to become ethical surgeons, they face greater challenges than have previous generations of surgical residents. To begin with, several decades ago, the overriding paradigm of medical decision-making was that of paternalism. This view suggested that physicians knew best what was good for their patients. Having this greater knowledge than their patients, physicians treated their patients much as a father treats a young child.189 The physician made unilateral decisions about what would be best for the patient. For many reasons, this paradigm has changed in recent decades. Now, with the importance of patient autonomy, the paradigm in medical decision-making has shifted to one of “shared decision-making.” This more complicated relationship with the patient requires the physician to be sensitive to the patient’s values and consider them in making recommendations for therapy. In addition to the complexities noted above in the interactions of physicians and patients, contemporary surgical patients also have many more options available in their treatment. The advances in technology have made it possible to keep many critically ill patients alive longer than could be done in the past. Surgical residents are then involved in caring for this sicker group of patients for whom the central question may not be, “what can be done?” but rather “what should be done?” This latter question is more complex because it involves the values of the patient. In contexts such as these, the issues of futility are often raised. Contemporary surgical residents are now faced with more and more patients for whom the question of whether there is acceptable value in continuing treatment can be raised. Inherent in addressing such difficult ethical questions as these will be the potential conflicts among physician, patient, and family members about what is “best” for the patient. An additional set of challenges to teaching ethics to contemporary surgical residents revolves around the changes in the way that surgical care is provided today compared with even 2 decades ago. Currently, patients spend relatively little time in the hospital. Much more surgery is performed on an outpatient basis or with a very short postoperative stay. Consider that the routine hospital stay for virtually all surgical procedures has decreased dramatically in the last 20 years. As a result, patients are often sent home before pathology reports are available and diagnoses are known. This change has made it much less likely that surgical residents, 436

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who spend the majority of their time in the hospital, will have the opportunity to witness their faculty having discussions with patients about treatment options. Similarly, the often-difficult discussions about an unexpected finding on a pathology report, for example, will rarely take place in the hospital. Therefore, surgical residents have progressively less exposure to the faculty having such interactions with patients and families. If one assumes that the faculty has something to teach on these issues, then this change in the location of such discussions will negatively impact the opportunities for surgical residents to see faculty addressing ethical issues in patient care. One potential response to this change has been the effort in many surgical residencies to shift more of the resident’s time into the outpatient setting where the resident can witness the many ethical issues inherent in interacting with patients. Despite the clear benefits to having residents spend time in the outpatient setting, the realities of treating many very sick patients in the hospital makes the competition for the residents’ time intense. This is an area where the faculty can have a significant influence on resident behavior if the outpatient experience is thought to be valuable.

Options for Teaching Ethics in Surgery

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In response to the challenges noted previously to teaching ethics to surgical residents, surgical faculty members have several options. Ethics can be taught formally or informally in many different fashions. The traditional way that ethics has been taught to generations of surgeons was informally as residents observed faculty members. This approach is dependent on the surgical faculty being good role models in acting in moral and ethical ways. This approach also depends on the residents having the opportunity to witness the interaction between faculty and patients when ethical issues are being addressed. Such an informal approach may be ideal for several reasons. In many cases, when the faculty member is especially experienced in addressing the clinical issues that arise in the care of patients, the residents will see real-life examples of how to address clinical issues skillfully. Often these “clinical” issues have significant ethical components, but they were rarely identified separately as ethical. For example, an attending surgeon’s conversation about a finding of metastatic cancer during an abdominal exploration might not be identified as a potential ethical issue in truth telling. Unfortunately, this approach is also dependent on the residents having the opportunity to witness these interactions, which might be difficult. Furthermore, if the resident is purely a passive bystander watching an interaction, the lessons learned might be readily forgotten. Yet another

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potential drawback of this approach is that each resident’s exposure to ethical issues will be completely dependent on the patients that are being cared for. As a result, significant ethical issues may be completely ignored if there are not patients who present with those dilemmas. An alternative approach to teaching ethics is to teach informally as ethical situations arise in the care of specific patients. Insofar as the resident is more fully engaged if the patient is known to the resident, this approach is also likely to provide more memorable lessons for residents. The ethical issues addressed are not artificial constructs, but grounded in the actual issues that arise in the care of specific patients. Often the most memorable teaching points are those that develop out of the actual problems encountered with patients and family members. Unfortunately, the resident experience is again dependent on what types of patients are actually cared for on any surgical service. A third possible approach to teaching ethics to surgical residents is formally as a lecture series. The benefit of such an approach is that a comprehensive set of topics can be covered. Since the subject matter of the ethical issues does not depend on the patients who happen to be seen, a large variety of topics can be reviewed. Despite this benefit, the passive nature of a lecture series makes it less likely that residents will remember the topics covered. The fourth possibility for teaching ethics is formally in an interactive fashion. Angelos and colleagues have described such an approach that depends on cases, debates, role simulations, and quiz game formats to maintain resident interest.183 Such interactive formal approaches to teaching ethics will be increasingly important in upcoming years because the ACGME has mandated that residents show competency in professionalism and communication skills. At this point no rigorous means of showing competency in ethics have been described. The development of methods to assess the ethical competency of residents will be critical in upcoming years.

Ethical Issues Inherent in Surgical Training A largely unexplored ethical issue that underlies surgical training is the question of who is actually “doing” the operation when a surgical resident is involved. The question may seem like a trivial one, but it is significant for many patients. Patients who are to have an operation at a teaching hospital not infrequently ask the attending surgeon, “will you be doing the surgery?” In situations where the attending surgeon is not scrubbed in the operating room, it is clear that the attending cannot be performing the operation. Similarly, in circumstances where the attending surgeon is 438

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operating with no involvement from any surgical trainees, the attending is clearly “doing” the operation. The difficulty revolves around the majority of operations at teaching hospitals where the attending and resident are both participating in the operation. When the attending surgeon is scrubbed and actively involved in the conduct of the operation, it is particularly unclear who is doing the operation. In other words, does the attending “doing the operation” mean that the attending is physically performing each of the tasks involved (eg, incising the skin, dissecting out each structure, and ligating each blood vessel)? Or alternatively, is the attending surgeon “doing the operation” if he or she is directing each and every step of the procedure even if the surgical resident is actually physically performing each of those actions? Although there is no clear answer to these questions, it is helpful to consider the issue of robotic surgery to illuminate these questions. Several companies have recently developed surgical robots that are currently being used to varying degrees by medical centers around the globe. A surgical robot can be directed to perform each of its movements by the surgeon either in the same room or at a distant location. The surgeon can move his or her arms and in turn the arms of the robot move the surgical instruments. Although no one yet has a large experience with such surgical robots, few would argue that the robot is actually performing the operation. Instead, most would agree that the robot is merely an instrument used in doing the operation and that the attending is actually performing the operation. In a similar fashion, if the surgical attending is directing the resident in each of the steps of the operation, one could argue that the surgery attending is “doing the operation.” The surgical resident cannot be seen as purely an extension of the attending surgeon. The attending surgeon may direct the resident to do a task, but either through the lack of skill or by choice, the resident might not complete the task successfully. In such cases, most would agree that the resident is “doing” that particular task. But it remains to be seen how many (or which) such tasks are necessary to credit the resident with “doing the operation.” Another topic that will need more attention in the future is how can the service and educational demands of a surgical residency be balanced in an ethical manner. With the advent of residency work hour restrictions, the longstanding problem of chronic sleep deprivation and overwork will likely be improved for surgical residents. Nevertheless, the ethical question remains how much service to require of residents in relation to their educational needs. From a purely ethical perspective, one would have to argue that the primary goal of a surgical residency should be to Curr Probl Surg, July 2003

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meet the educational needs of those individuals who seek to become surgeons. The challenge for surgical educators in upcoming years will be to determine what are the critical educational needs of residents so that these needs can be met appropriately. In the past, surgical residents spent so much time in the hospital taking care of surgical patients that even if the activities they were performing had little educational value, the shear volume of these activities would lead to adequate educational experiences. In the current environment, as residents will spend less time in hospitals, there must be attention directed toward what educational advantage can be gleaned from the more limited time spent in the hospital.

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REFERENCES

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