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Committee on EthicsEducation Reflections on Informed Consent: 40 Years After its Birth Jay Katz, MD I am a physician who has practiced psychiatry and psychoanalysis for 45 years. I am not a lawyer, although I have lived in the world of law for the last 39 years as a full-time faculty member at Yale Law School. I also am not a bioethicist; indeed, I began my work in law and medicine at a time when bioethics had not yet been discovered. I mention all this to convey to you that I consider myself a physician, proud of being a member of an honorable profession that has contributed so much to ministering to the sick entrusted to its care. I am also a professor of law, and my exposure to law has had a significant impact on my thinking about physicians and patients who, after all, are also citizens of a democratic society. My topic is informed consent. All of you have formed your own opinions about this legal doctrine, and I suspect that many of you consider it absurd, irrelevant, or even dangerous to the responsible practice of medicine. While reading this article, I invite you to banish these thoughts from your mind and to consider whether a good case can be made for informed consent, albeit not the kind of informed consent that is the norm in today's medical practice. Most of what I shall set forth here is based on my reflections about history, both medical and legal, and I shall conclude with some recommendations of what we must do ifwe want to take informed consent seriously. My emphasis on history is particularly appropriate today because it was 40 years ago—on October 22, 1957, to be precise—that the doctrine was promulgated in case law. Many colleagues have expressed surprise about this date, ascribing the emergence of the doctrine to a later or an earlier time. To be sure, two famous earlier cases—Pratt v. Davis in 19051 and Schloendorff v. The Society of New York Hospital in 19142—had addressed the question of surgery without patient consent. But in these cases, the patient had given no consent whatsoever to the operation. The surgeons did not contest that fact; instead they asserted that the beneficent interventions were necessary to protect the health of the patient. Thus, the legal issue was lack of consent, not informed consent. In Pratt, Justice Brown wrote that "under a free government ... the free citizen's first and greatest right, which underlies all others—the right to the inviolability of his person, in other words, his right to himself—is the subject of universal acquiescence, and [it] forbids [a surgeon] to violate the bodily integrity of his patient ... without his consent or knowledge."1 And in Schloendorff, Justice Cardozo had asserted that " [e]very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent, commits an assault ...."2 The claim that both Justices made was unqualified: Citizen-patient rights to bodily integrity are inviolable in a democratic society. The jurisprudential principle set forth in these two cases served decades later as the foundation for a new doctrine—informed consent. It was at that later date that the principle of "inviolability of person" required exegesis for medical practice and judicial adjudication; for example, the justices did not delineate the quality of information that physicians must provide so that patients could give meaningful consent that comported with the requirements of law. This issue will soon preoccupy us. But here I only want to point to an inherent tension between law and Hippocratic ethics: law's insistence on disclosure, and medicine's admonition to Hippocratic physicians that they "Perform [their duties] calmly and adroitly, concealing most things from the patient ... revealing nothing of the patient's future or present condition."3 The doctrine of informed consent, with its initial, though most tentative, pronouncements on patient roles in medical decision making, surfaced in Salgo v. Leland Stanford jr. University Board of7rustees in 1957.4 Martin Salgo's surgeon had suspected that the patient suffered from an obstruction in his abdominal aorta and recommended aortography to identify its precise location. The contemplated procedure required the injection of a dye, sodium urokon, which in 1954 had not "been used enough in the Bay area to constitute routine procedure." Salgo suffered a permanent paralysis. Although this was a rare complication, it was then considered a risk inherent in the procedure. The physicians admitted that they had not warned their patient of that risk. At the end of a lengthy opinion that dealt largely with standard negligence doctrines, Justice Bray of the California Court of Appeals, seemingly coming out of nowhere, delivered a brief discourse on disclosure and consent.4 What he said was confusing, but it ushered in the age of informed consent. By way of introduction, he averred that "[a] physician violates his duty to his patient ... if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment."4 Any facts? Consider Justice Bray's first formulation of the new legal doctrine: [I]n discussing the element of risk a certain amount of discretion must be employed consistent with the full disclosure of facts necessary to an informed consent."4 This was a startling piece of work. By going in two opposite directions—discretion and full disclosure—Bray's formulation went nowhere. I would like to recount a piece of detective work before turning to two subsequent cases that expanded on Justice Bray's pronouncements. For years I wondered where the doctrine had come from. The cases Bray cited made no reference to it. My students, research assistants, colleagues, and I conducted an intensive search, lasting many years, which did not unearth any prior case law on informed consent. Finally, it occurred to me that the amicus briefs, submitted to the District Court of Appeals, might aid my search. They were hard to obtain, but I succeeded. I was surprised to learn that justice Bray had adopted the entire paragraph on informed consent verbatim from the brief submitted by the lawyers for the American College of Surgeons.5 Thus, the American College of Surgeons is informed consent's godparent! Salgo was followed by Natanson v, Kline in 19606 and by Canterbury v. Spence in 1972.7 Mrs. Natanson had suffered severe injuries from cobalt radiation administered after a radical mastectomy. Cobalt radiation then was new to Wichita, KS, and both parties agreed that she had not, been informed of its hazards or the availability of alternative treatments. In this, the first extensive opinion on informed consent, justice Schroeder of the Kansas Supreme Court instructed physicians that from now on, they were under "the obligation to disclose and explain to the patient in language as simple as necessary the nature of the ailment, the nature of the proposed treatment, the probability of success or of alternatives, and perhaps the risks of unfortunate results and unforeseen conditions within the body. . ."6 Three points deserve attention. 1) Informed consent is all too often misunderstood (and judges have contributed to this confusion) to require a patient's "intelligent" or, as Franz Ingelfinger put it, "educated consent." This is not necessarily so. Surprisingly enough, the legal definition of consent remains remarkably unclear. It is important, however, to appreciate that informed consent is a hybrid concept, with "informed" addressing physicians' disclosure obligation and "consent" denoting the patient's response to the information provided. Thus, fidelity to informed consent requires, to begin with, informed and informing physicians. And, here too, as with consent, law has not clearly defined what constitutes disclosure, or how thoroughly the quality of patient understanding has to be probed. For example, physicians' obligation to provide information "in language as simple as necessary," as Justice Schroeder put it, gives physicians some, but, I believe, insufficient legal guidance about the quality of disclosure they are now obliged to make. (2) The reexamination of millennia-old patterns of communication between doctors and patients began not in medicine, but in law. I have often wondered whether the birth of informed consent was directly related to the remarkable advances in medical technology during the mid-20th century. Justices Bray and Schroeder might have felt uneasy that these novel and awe-inspiring medical procedures had injured patients rather than healed and, particularly, that this possibility had not been discussed with the patients. Thus, the judges might have wanted only to instruct physicians that, whenever great benefits may be associated with formidable and uncontrollable risks, such procedures should not be administered without prior conversation and consent. (3) The common-law judges who formulated the doctrine proceeded slowly; they did not want to burden physicians with too many new legal obligations because they were unsure how far they should intrude on the practice of medicine, about which they believed they knew little. Indeed, in Natanson, despite the amicus brief of the Kansas Medical Society that admitted the lack of disclosure, and then justified it on customary professional grounds, justice Schroeder limited the duty "to those disclosures which a reasonable medical practitioner would make .... "6 The law giveth and the law taketh away: Schroeder knew, or should have known, that physicians were not accustomed to sharing the burdens of decision making with patients. It took another 12 years for Judge Robinson of the D.C. Court of Appeals to observe in Canterbury v. Spence that "the reality of any discernible custom reflecting a professional consensus on communication of option and risk information to patients is open to serious doubt."7 He went on to assert without equivocation that "respect for the patient's right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves."7 Yet, it must not be overlooked that Judge Robinson and subsequent common-law judges restricted their task by and large to articulating new and more stringent standards of liability whenever physicians withheld what the law calls "material information" from patients. They did not set forth, in any depth, the nature and quality of disclosure and consent that would satisfy legal requirements. Moreover, the novel informed-consent doctrine created problems for judges. Theoretically, going back to Pratt and Schloendorf lack of informed consent should have been construed as battery, as trespass—an uninformed, and therefore, unauthorized invasion of a patient's bodily integrity—but if that had become the legal rule, doctors would have been limited to one defense, that is, that they had provided full disclosure. Instead, judges adjudicated allegations of lack of informed consent under negligence rather than battery law (trespass). Negligence law favored physicians by permitting them to invoke many defenses, including the "therapeutic privilege" not to disclose when in their judgment disclosure could prove harmful to the welfare of the patient. Courts have generally paid great deference to doctors' practices. This was recently expressed by the California Supreme Court when it overruled, wrongly I believe, its Court of Appeals' decision that had insisted that a terminal patient who was unlikely to benefit from further treatment must be informed of his dire prognosis.9 Instead, the Supreme Court ruled that " [w]e decline to intrude further, either on the subtleties of the physician-patient relationship or in the resolution of claims that the physician's duty of disclosure was breached, by requiring the disclosure of information that may or may not be indicated in a given treatment context."10 Note the tentative and deferential language of the Court: "We decline to intrude." Let me conclude my comments on the legal history of informed consent with one crucial observation: The doctrine was not designed to serve as a medical blueprint for interactions between physicians and patients. At best, judges wanted to prod physicians to articulate medical standards of disclosure practices that would conform better with basic legal principles. The medical profession did not do this, and we still face the task of fashioning a "doctrine" that is responsive to the realities of medical practices in an age of science and to the requirements of law in an age of informed consent. As I said years ago, "translating the ingredients of [the informed consent] process into legal and useful medical prescriptions that respect patients' wishes to maintain and surrender autonomy, as well as physicians' unending struggles with omnipotence and impotence in the light of medical uncertainty, is a difficult task [that the medical profession] has not pursued ... in any depth."11 Instead, physicians limited their new disclosure obligations to informing patients about the risks of a proposed intervention that often, but not always, have proved sufficient to escape legal liability. Physicians were not inspired to reconsider what patients ought to know, not only in an age of informed consent but also in an age when medicine had been radically transformed by its scientific revolution. This brings me to the history of medicine. Throughout the millennia of recorded medical history, and at least until the beginnings of the 20th century, physicians inevitably had to make unilateral treatment decisions on behalf of their patients. As expressed in the Hippocratic Oath: "I swear by Apollo and Aesculapius [that] I will follow that system of regimen which according to my ability and judgment I consider for the benefit of my patients . . . ." The patient was not mentioned as a person whose ability and judgment also deserved consideration. Nor did the first 1847 Code of Ethics of the American Medical Association address this issue.12 Instead, it admonished patients that their "obedience ... to the prescriptions of [their] physician should be prompt and implicit. [They] should never permit [their] own crude opinions ... to influence [their] attention to [their physicians]."12 Lest I be misunderstood, I am not critical of these ancient pronouncements. On the contrary, they were crucial to cure. In those days, faith, obedience, and the likelihood of cure were interconnected, as the French surgeon Henri de Mondeville recognized in the 14th century: "The surgeon ... should promise that if the patient can endure his illness and will obey the surgeon for a short time he will soon be cured .... If the patient is defiant, seldom will the result be successful."13 Until the 20th century, physicians could rarely even explain to themselves and, thus, to their patients which of their recommendations were curative and which were not. To be sure, careful bedside observation assisted doctors in doing their level best "to abstain from what [was] deleterious and mischievous, to help if they could, and most of all to be available for comforting reassurance. Doing more curatively, with a greater awareness of what they were doing, became possible only with the advent of the age of medical science. The introduction of scientific reasoning into medicine, aided by the results of carefully conducted research, permitted doctors for the first time to discriminate better among knowledge, ignorance, and conjecture in their recommendations for or against treatment. Moreover, the spectacular technologic advances in the diagnosis and treatment of disease, spawned by medical science and technology, provided patients and doctors with ever-increasing therapeutic alternatives, each having its own particular benefits and risks and, in turn, far-reaching consequences for quality of life. Physicians also began to understand these matters better. I want to underscore "better" because a new problem arose: "medical uncertainty." As the physician-scientist Lewis Thomas aptly put it: "It is [the] sudden confrontation with the depth and scope of our ignorance that represents the most significant contribution of twentieth-century science to the human intellect. "And he added, "we are at least facing up to it." But we rarely faced up to it with our patients, believing instead that knowledge of uncertainty in our treatment recommendations was not in their best interests. Moreover, we have not faced up All this notwithstanding, for the first time in medical history it has become possible to invite patients to participate in medical decision making, although we must learn not to replace our traditional authoritarian ways of interacting with patients with an unwarranted scientific authoritarianism. Yet, there has been progress, and it is an achievement that, beginning with the promulgation of the doctrine of informed consent and the emeraine literature on autonomy and self-determination, the selfconsciousness of physicians has been raised about the rights of patients to be better informed. The fact that self-consciousness has only begun to affect our practices is another matter. I have been chided that my recent writings are dated: that informed consent is no longer a problem. From what I have said already, I of course disagree. From another perspective, Sherwin Nuland, the distinguished surgeon and equally distinguished author, in his recent book, How We Die, supports my position: "A surgeon, though he be kind and considerate of the patient he treats ... allows himself to push his kindness aside because the seduction of the Riddle [ie, the quest for diagnosis and cure] is so strong and the failure to solve it renders him so weak, [that at times he convinces] patients to undergo diagnostic or therapeutic measures at a point in illness so far beyond reason that The Riddle might better have remained unsolved."16 Speaking then about the kind of doctor he will seek out when afflicted with a major illness, Nuland writes that he does not expect him to "understand my values, my expectations for myself... my philosophy of life. That is not what he is trained for and that is not what he will be good at. Doctors can impart information, but [i]t behooves every patient to study his or her own disease and learn enough about it. [Patients] should no longer expect from so many of our doctors what they cannot give .... "16 Although I do not share his judgment that physicians cannot do better, Nuland's views, supported by a great many poignant clinical vignettes, sensitively and forthrightly describe the current state of physician-patient decision making, so dominated by physicians'judgments as to what is best. Nuland presents many reasons for this state of affairs. One is based on physicians' "fear of failure, [and, in turn] a need ... to maintain control [which], usually without being aware of it, [leads him to convince] himself that he knows better than the patient what course is proper. He dispenses only as much information as he deems fit, thereby influencing a patient's decision making in ways he does not recognize as selfserving."16 I have presented Nuland's observations at some length because they illustrate and support my contention that joint decision making between doctors and patients still eludes us. During the decades of my work on the physician-patient relationship, my conviction has only increased that patients must play a more decisive role in decisions that can affect their lives and well-being in such important ways. And physicians now can attend to the task of making this possible. Medicine has begun to emerge from its prescientific past in wondrous ways. It now can offer many more treatment modalities and it can do so not by intuition, but with greater understanding of the alternatives and their consequences. At one time in our history, "patient" and "person" were interchangeable, but thanks to our accomplishments, this is no longer necessary. Persons become patients only after they have agreed to entrust their bodies to our care. And trust requires that they know what they are trusting. Thus, when a person enters our office for the first time, he or she is a person who may become a patient, but only if, after an exploration of what both medicine and we can offer, that new status has been mutually agreed upon. Persons may want something else, and then they cannot become our patients. To put this another way, we continue to homogenize the concept of person and patient and then take ownership of the patient's body that belongs to the person and not to us. Not to merge person and patient prematurely is a difficult undertaking, and we have only begun to consider its complexities. Our Hippocratic history, as I have suggested, makes such distinctions difficult. It requires conversation between doctors and personpatients that for millennia was beyond our grasp. Now managed care may reverse the progress we have made of talking with patients, and Hippocratic authoritarianism may resurface under a new guise: managerial authoritarianism. In my view, patient autonomy and self-determination, which underlie informed consent, are crucial to the physician-patient relationship. You may not agree with my vision of informed consent, but then consider whether the mindset you bring to informed consent limits the information you provide and the consent the patient gives. At least you will then not deceive yourselves. The danger that current informed-consent discussions pose for physicians and patients is this: The parties believe that they are informing and being informed about diagnosis and treatment options to a greater extent than is the case. To put this another way, the illusion of informed consent inheres in our current practices. In my work on the physician-patient relationship, the principle of autonomy is the Ariadne's thread that has guided my way. (And I want to underscore that I limit myself here to the individual interactions between physicians and patients and leave unconsidered, for example, inroads on autonomy for societal considerations; eg, the rationing of expensive medical services.) Although I believe that abstract principles are important starting points, they are only starting points. Abstractions in the world of medicine, as elsewhere, require commentary that, with fidelity to principle, give a human dimension to the intertwined lives of physicians and patients. Thus, I developed a new concept—"psychological autonomy." By psychological autonomy, I wanted to convey that human beings'—including patients' and physicians'—capacity for autonomy is fragile and that its optimal, never perfect, exercise requires nurture and support in the context of a relationship and not in the isolation of silencing authoritarianism and silent acquiescence or noncompliance. Both physicians and patients must pay caring attention to each others' real, although precarious, endowment for reflective thought and decision making. This is why I place so much emphasis on conversation. Conversation is essential to enhancing psychological autonomy, not only for patients' sake but for physicians' sake as well; for during such conversations, physicians may also recognize how vulnerable they are. Recall Nuland's cogent observations about surgeons' quest to solve "the Riddle" and their "fear of failure," which can drive them to "convince patients to undergo [procedures] far beyond reason."16 Remaining fixed in the Hippocratic tradition of "doctors' orders" can hide physicians' appreciation of the many ways in which "the good of medicine" can be achieved from the perspective of patients who may value some goods more than others. Conversation can illuminate these perspectives, and during such conversations doctors must discuss with patients not only risks and benefits, but also alternatives to, and uncertainties inherent in, their recommendations. And in these conversations, they must also allow patients to clarify what they want: how they want to manage their medical lives in light of the extent and limits of what medicine can offer. My emphasis on conversation has been misunderstood to require a, lengthy, even psychoanalytic, exploration of patients' minds. This has not been my intention. I merely wished to suggest that it is possible to go to some length in subjecting physicians' and patients' thoughts and contemplated actions to clarification through dialogue which, in turn, may lead to a better understanding of what is at stake in the medical decisions to be made. Doing more is impossible, and doing that much may not persuade patients to choose a course of action that is "in their best interests." But as Supreme Court justice John Stevens once put it, "it is far better to permit some individuals to make incorrect decisions than to deny all individuals the right to make decisions that have a profound effect upon their destiny."17 The obligation to converse is bilateral between physician and patient. I have been criticized that my postulated obligation for patients to participate in conversation with their physicians reintroduces paternalism into the physician-patient relationship and also constitutes an invasion of patient privacy. But absent such an obligation, psychological autonomy is reduced to an abstraction, akin to autonomy, that is inattentive to the reality of both the strength and fragility of the human mind. Jennifer Nedelsky put it well when she wrote that "autonomy ... takes its meaning [not only] from the recognition [and respect for] the inherent individuality of each person, [but also] from the recognition that individuality cannot be conceived of in isolation from the social context in which that individuality comes into being. The value of autonomy will at some level be inseparable from the relations that make it possible . . . . "18 The obligation to converse and the value I place on autonomous choice do not preclude patients from requesting that doctors make decisions for them. Autonomy must respect a patient's waiver of decisionmaking authority. I only argued, and still do, that the physician is obliged to make a searching inquiry into why patients have so decided and to reassure them that he or she is willing to converse with them. The history of the physician-patient relationship bears testimony to the fact that doctors have discouraged such conversations and that patients have been afraid to "waste" doctors' time and incur their displeasure for "imposing" on them. If it is "for the good of the patients" to participate in decision making—not only because law encourages it, but also because it is good medical practice—then doctors must recognize that while neediness invites passivity, doctors must caringly try to reverse it. In my previous writing I have said little about beneficence, a principle deeply ingrained in the conscience of physicians. Throughout most of medical history, that principle served patients well, for until the age of medical science, as I have repeatedly emphasized, many therapeutic interventions were useless, often dangerous, and Aesculapian power and faith in the physician were major ingredients of "cure." In those days, admonitions to physicians to be beneficent, to do no harm, and to do whatever they could for the good of the patient carefully and selflessly cannot be faulted. But we live in a different age now, and we should not transport ancient justifications for beneficence, silently bestowed, into this century. For todays medical world, a new question has surfaced: Whose articulated version of the "good": the patient's or the physician's? In their remarkable book For the Patient's Good, Edmund Pellegrino and David Thomasma tackle this question, and I agree with much that they set forth there. They give considerable weight to the importance of autonomy and almost totally reject paternalism. Although they are unpersuaded "that [any] one principle of ethics could govern all health care practice," 19 they nevertheless propose one, by collapsing two principles into one—"beneficence-intrust"—which "conflates two very important ethical concerns in medicine autonomy and beneficence." 19 Coming from two distinguished and respected persons, one a physician and the other a bioethicist, their statement about the importance of autonomy is a significant advance. But I have problems with their conceptualization, particularly because of the history of beneficence in medical practice, where beneficence can so readily shade over into paternalism. If they needed a new concept, I wish they had called it not "beneficence-in-trust" but "autonomy-in-trust." I remain concerned that beneficence as a first principle may overwhelm autonomy; beneficence is freighted with too much history of interacting with patients in terms of what physicians think is best for them. Moreover, as I have already suggested, in today's world physicians differ radically about what is best, and advances in medical technology offer many options, each with their own impact on quality of life. Thus, the principle of autonomy emerged not only because of Law's commitment to patient selfdetermination, but also because what is in a patient's best interest in this modern age should not be left without question to the differing views of doctors as to what they believe is best. Pellegrino and Thomasma recognize that "beneficence can be and has been subverted into paternalism,"19 and they make a commendable effort to distinguish between the two. But it is the alliance between beneficence and paternalism that continues to haunt beneficence. Paternalism still has its advocates. As one distinguished physician argued: "Paternalism exists in medicine ... to fulfill a need created by illness. [The physician who] witnesses the trajectory of illness and dying [should] use [his or her] experience to anticipate and advise regarding the outcome of illness and [sustain patients] in the agony of illness."20 But, how often will patients not heed a doctor's advice to persevere when he or she can reassure them "that the trajectory of the illness will have a positive outcome?"20 In my view, under these circumstances, patients will either (and most likely) join forces with physicians, for the will to live is strong; or they will advance good reasons why they are ready to give up and, if so, their reasons deserve respect. It is dangerous in the name of the moral authority of physicians to abrogate the moral authority of patients to make their own decisions because "patients' best interests" require it. Consider how often the interests of vulnerable individuals and groups have been violated by protective actions justified as being in their best interest: Slaves, women, the mentally ill, and patients as well are examples of such "protected groups." Rather than cede the moral authority of patients to the physician by virtue of the physician's knowledge and expertise, I would contend that we 20th-century physicians, by virtue of our increased capacity to communicate our knowledge about health and disease, should lead the way in implementing the idea that patients must ultimately decide what is in their best interests. In 1984, the judicial Council of the AMA, in its commentaries on the AMA's Code of Medical Ethics, briefly addressed informed consent. I was struck that almost 30 years after its promulgation, the Council called (as it still does today) informed consent "basic social policy"21 (emphasis added) and not basic medical policy. Thus, it is not surprising that the Council briefly highlighted patients' rights to self-determination but did not provide any commentary on how physicians should deal with the complex disclosure and consent issues that they will now encounter in their medical practices. I urge the AMA and the various specialty organizations to establish committees that will attend to the task of giving meaning to the requirement of informed consent for doctors' varied prototypical practices. Membership of these committees should be limited to physicians because it is they who work in the trenches. Academic medicine also must get more involved by establishing, side by side with anatomy, pathology, pharmacology, and other disciplines, a department that pursues these medical-legal-ethical problems in depth. Publications of such research by faculty and students could make significant contributions to resolving these complex issues. Among the many matters to be considered is a suggestion I once made that the unitary scope of the informed-consent doctrine requires reexamination in light of the diversity of medical practices. It does not make sense to encompass all that medicine does under a monolithic rule on disclosure. Physicians have complained about this but have made no remedial proposals. I suggested that disclosure requirements be adapted to at least four subgroups of practice.22 1) For acute disorders (eg, myocardial infarctions or impending perforating ulcers) that require immediate intervention as well as keeping the patient as free of anxiety as possible, disclosures may have to be limited to the most essential facts. 2) For elective procedures (eg, hysterectomies, tonsillectomies, and cholecystectornies) for which a variety of treatment options (including no treatment) may be indicated and there is no rush to proceed, the fullest disclosures should be stringently enforced and shared decision making should be an absolute, requirement. 3) For conditions in which the prognosis is dire (eg, cancers) and a fatal outcome is likely, the pace of disclosure may have to be slower so that patients' reactions to learning about their disease or life expectancies can first be ascertained. Here, at least some delay may be justifiable, yet eventually physicians should be guided by the presumption of disclosure and consent that cannot easily be overridden. 4) For relatively minor, time-limited disorders for which treatments expose patients to minimal risks (eg, the common cold, nonspecific headaches, or certain dermatologic disorders), informed consent could be dispensed with, if the patient agrees. These are among the issues that the medical profession must consider carefully. Eventual proposals could serve judges as guides to evaluate, and rule on, the limits of accommodations to the realities of medical decision making in an age of informed consent. This is the 40th anniversary of the birth of informed consent. We still have a long way to go to translate theory into practice. To this pursuit I have devoted decades of work, now endangered by the age of managed care. Although the evolution of managed care is still sufficiently in flux to preclude any final judgment, evidence is accumulating that the practice of medicine, as we have known it, is endangered. These new developments have their own history. The profit motive began already in the mid- 1940s to infiltrate the practice of medicine to an extent unknown in earlier centuries. The venerable distinctions between medicine and business, or as Talcott Parsons once put it,23 the differences between professionalism and commercialism that distinguished medicine from business, were already eroding before the advent of managed care. But now corporate entities, with highly paid administrators and profit-seeking stockholders, could undermine as never before professional practices deeply ingrained in our tradition. In reflecting on managed care's darker side, it occurred to me that informed consent could serve a purpose not envisioned at the time of its birth. We are now beleaguered by merchants, including, alas, physicians turned merchants, a new development in the history of medicine. We need help, and this help could come from our patients. If we are willing to take informed consent seriously, and decide to take patients into our confidence about the ends of medicine when they seek our help, and do so by conversing with them about available options, risks, benefits, quality of future life, and medical uncertainty—that is, by sharing with them our knowledge, ignorance, and frustrations over being unable to provide diagnostic tests and treatments because managed care will not authorize them—then we can create an unaccustomed partnership with our patients and enlist them in a common cause for their good and for the good of medicine. After all, patients are citizens, and an aroused citizenry can make its dissatisfactions known at the ballot box. But this will happen only if we first learn to treat patients as persons. To put this another way, the doctrine of informed consent, which began with safeguarding patient rights to self-determination in their interactions with doctors, now could also protect doctors from unwarranted intrusions by business and insurance companies into the practice of medicine. The great Harvard Medical School physician, Francis Peabody, in his famous lecture on "The Care of the Patient," told us that "one of the essential qualities of the clinician is his interest in humanity, for the secret of the care of the patient is caring for the patient."24 I puzzled for years over his repetition of the word patient. After many rereadings of his lecture, I was struck by his appeal to the physician's humanity as a counterpoint to objectifying patients. Thus, I changed one word in his last sentence: " [T] he secret of the care of the patient is Caring for the person." In our interactions with patients, we must learn to respect the autonomous person before us and we must learn to listen to the person-in-the-patient while deciding jointly what course of action to follow. In 1957, informed consent, I believe, served the important purpose of beginning to redress the power imbalance between physicians and patients. In the waning years of the 20th century, informed consent may serve us well to tame the onslaught of commerce. Now, more than ever before, we require informed citizen-patients so that they will help us to maintain and secure the caring dimension of medicine. How surprising a development: Am I dreaming when I wonder whether caring for patients, caring for persons, and caring for medicine are now more closely intertwined than we had ever envisioned? References 1. Pratt v. Davis, 118 111. App. 161 (1905). 2. Schloendorff v. The Society of New York Hospital, 105 N.E. 92 (1914). 3. Hippocrates: Decorum. (Jones W, Trans.). Cambridge: Harvard University Press; 1967:297. 4. Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170 (1957). 5. American College of Surgeons. Brief as Amicus Curiae in Support of Defendant and Appellant Frank Gerbode (1956). 6. Natanson v. Kline, 350 P.2d 1093 (1960). 7. Canterbury v. Spence, 464 F.2d 772 (1972). 8. Ingelfinger FJ. Informed (but uneducated) consent. N Engl J Med 1972;287:465-466. 9. Arato v. Avedon, 11 Cal. Rptr. 2d 169, 181 (1992). 10. Arato v. Avedon, 858 P.2d 598, 607 (1993). 11. Katz J. The Silent World of Doctor and Patient. New York: The Free Press; 1984:84. 12. American Medical Association. Code of ethics (1847). Reprinted in Katz J. The Silent World of Doctor and Patient. New York: The Free Press; 1984:230-236. 13. de Mondeville H. Chirurgie de maitre Henri de Mindeville. ca. early 14th century. In: Welborn MC. The Long Tradition—A Study in Fourteenth Century Medical Dermatology. Reprinted in Burns CR, ed. Legacies in Ethics and Medicine. New York: Science History Publications; 1977:213. 14. Thomas L. The Medusa and the Snail—More Notes of a Biology Watcher. New York: Viking Press; 1979:73-74. 15. Smith R. The ethics of ignorance, J Med Ethics 1992;18:117,118. 16. Nuland SB. How We Die. New York: Alfred A. Knopf; 1994:249-266. 17. Tbornburgh v. American College of Obstetricians & Gynecologists, 476 U.S. 747, 781 (1986). 18. Nedelsky J. Reconceiving autonomy: sources, thoughts and possibilities. Yale J of Law and Feminism 1989;1:7,36. 19. Pellegrino ED, and Thomasma DC. For the Patient's Good. New York: Oxford University Press; 1988:54,36. 20. Duffy TP. Agamemnon's fate and the medical profession. Western New England Law Rev 1987;9:21,26-27. 21. Judicial Council of the American Medical Association. Current Opinions of the Judicial Council of the American Medical Association. 1981:25. 22. Katz J. Physician-patient encounters "on a darkling plain." Western New England Law Rev 1987;9:207,221-222. 23. Parsons T. The Social System. Free Press of Glencoe; 1951:471-472. 24. Peabody F. The care of the patient. JAMA 1927;88:877,882. Received November 18, 1997; Revised January 13, 1998; Accepted for publication January 13, 1998. From Elizabeth K. Dollard Professor Emeritus of Law, Medicine, and Psychiatry, and Harvey L. Karp Professorial Lecturer in Law and Psychoanalysis, Yale Law School, New Haven, CT. © 1998 by the American College of Surgeons Published by Elsevier Science Inc. Ethics and Philosophy Lectures
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