6
An Ethical Framework for CAM Research, Practice, and Policy

The statement of task given to the committee necessarily involves consideration of ethical issues. The exploration of the “scientific, policy, and practice questions that arise from the significant and increasing use of complementary and alternative medicine (CAM) therapies by the American public” and “the translation of validated therapies into conventional practice” require that the ethics of medicine be probed in two domains. The first is the individual provision of personal health services; the second is the profession’s social advocacy for public health. The statement of task also addresses the development of “models and frameworks” that would be appropriate for the translation of CAM therapies. Ethical models and frameworks for human subjects research as they apply to CAM are an essential part of this development.

VALUE COMMITMENTS THAT INFORM THIS CHAPTER

To accomplish its task, the committee addressed the ethical questions in CAM research, practice, and policy. Yet, even undertaking this task required that some ethical assumptions be made. The committee believes that five major ethical commitments must be embraced. These deserve explicit acknowledgment because they serve as presuppositions or premises of this chapter. The first three are more familiar and will be discussed briefly. The last two receive more expansive treatment because they are less familiar and because they are central to a fair and comprehensive understanding of CAM therapies.



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Complementary and Alternative Medicine in the United States 6 An Ethical Framework for CAM Research, Practice, and Policy The statement of task given to the committee necessarily involves consideration of ethical issues. The exploration of the “scientific, policy, and practice questions that arise from the significant and increasing use of complementary and alternative medicine (CAM) therapies by the American public” and “the translation of validated therapies into conventional practice” require that the ethics of medicine be probed in two domains. The first is the individual provision of personal health services; the second is the profession’s social advocacy for public health. The statement of task also addresses the development of “models and frameworks” that would be appropriate for the translation of CAM therapies. Ethical models and frameworks for human subjects research as they apply to CAM are an essential part of this development. VALUE COMMITMENTS THAT INFORM THIS CHAPTER To accomplish its task, the committee addressed the ethical questions in CAM research, practice, and policy. Yet, even undertaking this task required that some ethical assumptions be made. The committee believes that five major ethical commitments must be embraced. These deserve explicit acknowledgment because they serve as presuppositions or premises of this chapter. The first three are more familiar and will be discussed briefly. The last two receive more expansive treatment because they are less familiar and because they are central to a fair and comprehensive understanding of CAM therapies.

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Complementary and Alternative Medicine in the United States 1. A social commitment to public welfare. In terms of medical therapies, a commitment to public welfare is the obligation to generate and provide to health care practitioners, policy makers, and the public access to the best information available on the efficacy of CAM therapies. This is a duty of beneficence (Beauchamp and Childress, 1994; Churchill, 1995). 2. A commitment to protect patients and the public generally from hazardous medical practices and to inform practitioners, policy makers, and the public of select therapeutic modalities that are potentially injurious or deleterious to health. This commitment is closely related to the first one and is often expressed in the bioethics literature as a duty of nonmaleficence, and by physicians as primum non nocere—first, do no harm, which comprises the Hippocratic Oath from the sixth century B.C.E. (Beauchamp and Childress, 1994). As will be discussed in this chapter, nonmaleficence in approaching CAM therapies by individual practitioners includes respecting divergent cultural beliefs; creating an emotionally safe environment for the discussion of CAM; and appreciating how CAM may fit into a patient’s larger social, familial, or spiritual life (Adams et al., 2002; Cohen, 2003). Nonmaleficence in policy decisions includes such things as devising appropriate research strategies and labeling and advertising policies that protect the public. 3. A respect for patient autonomy (or in social terms, a commitment to consumer choice in health care). Autonomy expresses the interest in allowing and actively enabling individuals to make knowing and voluntary choices in health care, in accord with their own values. Such choices cannot be made without the provision of information regarding benefits and risks that are implied in the first two commitments, so in this way respect for the autonomy of patients (and choice for consumers) is possible only when individuals and social agencies exercise beneficence and nonmaleficence when they are in the position to do so (Beauchamp and Childress, 1994). 4. Recognition of medical pluralism (Callahan, 2002; Kaptchuk and Eisenberg, 2001). Serious consideration of the safety, efficacy, and potential integration of CAM therapies into conventional medicine means acknowledgement of multiple valid modes of healing and a pluralistic foundation for health care. Many CAM practices (such as chiropractic, acupuncture, naturopathy, and homeopathy) are rooted, at least in part, in forms of evidence and logic other than those used in biomedical sciences, often with long traditions and theoretical systems of interpretation divergent from those used in biomedicine. Investigation of CAM practices entails a moral commitment of openness to diverse interpretations of health and healing, a commitment to finding innovative ways of obtaining evidence, and an expansion of the knowledge base relevant and appropriate to medical practice. This commitment to openness also includes reconsideration of

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Complementary and Alternative Medicine in the United States the meaning and the relevance of ethical norms that guide various research and clinical activities, as discussed below. The recognition of medical pluralism is one way to honor social pluralism, that is, the broad differences in preferences and values expressed through the public’s prevalent use of CAM modalities. From a societal perspective, the effort to investigate CAM practices sensitively and analytically means acknowledging that social norms and expectations for medicine have always been in transition, such as an increased focus on dealing with illness experiences, the importance of holistic, healing interactions with clinicians and providers, and wellness and health promotion as goals (Ritvo et al., 1999; Truant and McKenzie, 1999). A focus on organ function, biological markers, and disease-related variables is restrictive and is no longer an adequate reflection of the social values of patients or the public’s expectations for effective health care (Glik, 2000; Jonas, 1998; Mike, 1999; Thorne at al., 2002). Importantly, recent studies suggest that some conventional physicians no longer conceive of their practices as limited by their biomedical training and that some practitioners are discussing, referring to or practicing some of the more prominent forms of CAM and believe them to be useful or efficacious (Astin, 1998). Yet, care must be taken not to assume compatibility where none exists. Medical pluralism should be distinguished from the cooptation of CAM therapies by conventional medical practices (Kaptchuk and Eisenberg, 2001). Although some conventional medical practices may seek and achieve a genuine integration with various CAM therapies, the hazard of integration is that certain CAM therapies may be delivered within the context of a conventional medical practice in ways that dissociate CAM modalities from the epistemological framework that guides the tailoring of the CAM practice. If this occurs, the healing process is likely to be less effective or even ineffective, undermining both the CAM therapy and the conventional biomedical practice. This is especially the case when the impact or change intended by the CAM therapy relies on a notion of efficacy that is not readily measurable by current scientific means. A commitment to medical pluralism also has major implications for how research is conducted. Howard Brody puts the problem succinctly: “Therapies that might be highly effective within the proper cultural and belief context might prove to be totally ineffective within the foreign environment required for and created by the conduct of an RCT [randomized controlled trial]” (Brody, 2002). Thus, medical pluralism requires a commitment to finding innovative ways to assess efficacy, in accord with its multiple meanings and the diverse contexts in which it may occur. In sum, the practice of medical pluralism will mean moving beyond any medicocentric claims for the ultimate ability of biomedicine to incorporate

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Complementary and Alternative Medicine in the United States all CAM therapies that are of use while discarding the rest. This will require suspending any categorical disbelief in CAM therapies, at least long enough to consider the evidence for safety and efficacy dispassionately (and sometimes innovatively) and in their appropriate contexts rather than only within the framework of conventional medicine practice or the usual scientific norms. Thus, the committee suggests that the proper attitude is one of skepticism about any claim that conventional biomedical research and practice exhaustively account for the human experiences of health and healing, combined with diligent efforts to discern the significance, safety, and efficacy of CAM therapies. 5. The first four ethical commitments (to personal and public beneficence, to protection, to patient autonomy and consumer choice, and to medical pluralism in the service of these aims) provide the general framework for this chapter and inform the committee’s selection of areas that require more extensive exploration. In explicitly stating these commitments, the committee also implies a fifth commitment, namely, public accountability, both for this report and its findings and for the health care system in the United States. Were medical research and health care a private matter paid for by private funds and with few social consequences, such public accountability would not be required. Yet, health care, as well as the medical research that supports it, is a public trust that is largely funded with common resources and that has broad societal consequences. Accountability to the public for prudent and fair assessment and use of medical and health care resources is a necessary component of this report. The committee recognizes the complexity of a commitment to public accountability for CAM therapies. For example, many consumers access CAM therapies outside the context of primary or other medical care; pay for such therapies out of pocket; do not consult with their physicians regarding such care; and use CAM therapies for relaxation, wellness, spiritual awareness, or reasons other than biomedical disease management (Eisenberg et al., 1993, 1998). Similarly, many CAM therapies are offered as part of a healing process that involves meaning and is attentive to the illness experience and perceptions of risk and vulnerability. Many CAM providers regard their therapeutic regimens to be other than and outside systems of conventional medical care, reimbursement, or even licensure, and are concerned with healing as distinct from curing (Young, 1982; Eisenberg et al., 2002). The question of whether licensure, reimbursement, and inclusion within hospital-based, integrative models of care would be a socially desired good or an undesirable compromise (or even a dilution of healing traditions) becomes especially significant when one considers that prayer, meditation, and other forms of spiritual healing exist within the rubric of CAM therapies. For many CAM providers offering services in these do-

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Complementary and Alternative Medicine in the United States mains (and their patients), the significance of a given therapeutic intervention may be less about efficacy on the physiological level and more about emotional health, coping, psychological growth, transformation, and self-actualization (Maslow, 1968). Likewise, therapeutic efficacy may involve such arguably vague but no less powerful spiritual themes as reconciliation with the divine or other formulations of “at-one-ment” and wholeness, or simply, perhaps, a renewed or more expanded sense of self (Astin and Astin, 2002). Stated in these terms, providers offering (and clients availing themselves of) some of these therapies may focus less on the kind of physiological results validated by evidence in medicine and public health and more on intangible, yet nonetheless compelling, personal benefits. Such services may have less kinship with technologically oriented, biomedical interventions and greater kinship with therapies at the borderland of psychological and spiritual care that are offered in professions such as pastoral counseling and hospice. Stated slightly differently, by virtue of their overtly psychological or spiritual aspirations, some of these therapies may have less to do with outer results and may have more to do with a kind of “inner revolution.” For example, Robert Thurman links inner spiritual evolution and outer social change through Tibetan Buddhist psychological and religious teachings (Thurman, 1998). In the Western traditions, philosophers and religious thinkers as diverse as Plato and Mary Baker Eddy have ascribed to linkages between health and various ritual practices, beliefs, or ways of thinking. Thus, although physicians or public health professionals may speak in terms of morbidity, mortality, and risk factors, other kinds of clinicians and therapists may think in terms of healing the shadow self and increasing the capacity for intimacy and mature love (Fromm-Reichmann, 1960) or the growth of (and care for) the soul (Ingerman, 1991). Some physicians would even link these two domains (Ornish, 1998). In other words, public accountability, like medical pluralism, must include some consideration of the vast array of perspectives that constitute the national (and even international) heritage of healing traditions. In this light, some CAM providers would prefer that their healing traditions remain outside conventional systems of care and reimbursement and beyond the reach of efforts at integration (Cohen, 1998; Eisenberg et al., 1998). The complexity and persistence of such issues are evident not only in the domain of licensure and credentialing but also in the domain of herbal products. Questions have arisen, for example, who can own the knowledge of indigenous herbal traditions; who should own such knowledge; and under what conditions (or even whether at all) may such knowledge be transferred, developed, commercialized, or maintained as private (or in some traditions, sacred, and thereby beyond public dissemination)?

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Complementary and Alternative Medicine in the United States Such questions also touch on the nature of scientific evidence and whether methodologies appropriate to these issues of accountability can be designed. An additional complicating factor in public accountability is that companies that have successfully marketed a CAM product may have not only philosophical reservations but also little or no financial incentive to have their product tested in independent settings. Perhaps only those companies that strongly believe in their products and that are willing to risk the revealing of evidence contrary to their convictions about their products (and those of loyal practitioners and customers) would willingly participate in research on their products. An additional financial disincentive is the difficulty in securing a patent on many of these products. Yet, insofar as these products are part of health care practices and are labeled or used as such by the American public, the manner is which they are regulated should account for all five of the ethical commitments outlined here, including accountability. Accountability thus includes a sensitivity to the complex needs and desires of multiple constituents within the public sector (e.g., licensed clinicians and other healers, patients, professional organizations, regulatory boards, and other government authorities) and at the same time a recognition of the heterogeneity of communities and interests within each set of constituents (e.g., multiple regulatory boards with overlapping or intersecting authorities; multiple professional groups with competing theories, definitions of practice, lineages of tradition, and legislative goals; multiple patient and consumer protection groups, each balancing the paternalism-autonomy dilemma in different ways; and multiple stakeholders within the federal government and state governments). Accountability also includes a sensitivity to the blurring of boundaries that increasingly occurs not only between the legally authorized scope of practice for different professions (for example, the overlap between professions such as chiropractic, physical therapy, and massage therapy) (Cohen, 1998) but also between emerging (or frontier) practices in medicine, the mental health professions, CAM professions that use bioenergetic or biofield approaches to therapy (NIH, 1995; Jonas and Chez, 2003), and various forms of spiritual care (Cohen, 2003). For example, hypnosis and guided imagery are related therapies that may cross the chasm between the physical and the metaphysical realms, as both can be used for different purposes by surgeons, dentists, and massage therapists, as well as in clinics for smoking cessation and weight loss and in hospice. Moreover, therapeutic goals can range from pain reduction and accelerated healing to the kind of growth envisioned in fields such as transpersonal psychology (Rosen, 1982). Sensitivity to all the complexities described above will be evident in the committee’s approach, the ethical commitments highlighted, and the recommendations.

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Complementary and Alternative Medicine in the United States VALUE JUDGMENTS IN DEFINING CAM Value judgments are implicit in the term CAM itself. Just deciding what should be categorized as a CAM therapy—as distinct from a religious ritual or a cultural practice—from among the dozens of alternative practices is a decision with important value implications. The reasons for defining modalities as “CAM therapies” are not only scientific but also political, social, and conceptual (Jonas, 2002). These include a lack of a generally accepted explanatory model; the fact that the origin of the practice (e.g., acupuncture) is outside of the dominant system; the amount of data or the type of data is considered insufficient or otherwise inadequate (e.g., herbalism and megavitamin therapy); the use of the practice is marginalized in that it is not widely available within conventional hospitals (e.g., chiropractic); the teaching of the practice is marginalized in that it is not generally taught within medical, nursing, or graduate schools of the dominant institutions (e.g., nutritional therapy); the amount of research funding, infrastructure, and capacity for investigating the practice is low (e.g., massage); reimbursement for the practice is not provided by insurance companies and third-party payers; the practice is not readily used for feasibility, acceptability, or other reasons (e.g., clinical ecology and complex lifestyle programs); the practice is not regulated or licensed in most states (e.g., naturopathy); and an aspect of the therapy is marginalized, even though it is studied under other names or subdivisions (e.g., antineoplastons and shark cartilage). In brief, when something is labeled “CAM”: and when “CAM therapies” are sorted and differentiated, it is important to recognize the diverse social and political value judgments at work. These value judgments are sometimes embedded in the scientific, medical, and educational rationales for health taxonomies. Attending to these implicit value components will reduce the likelihood of miscategorization and misunderstanding. The following sections address three sets of ethical issues in CAM research and practice: ethical issues in CAM research; ethical issues in the integration of CAM therapies into conventional practice; and related legal and regulatory issues. Some of the conclusions from this chapter are included in the recommendations of other chapters of the report. An additional aim of this chapter is to raise questions and flag areas that practitioners, researchers, and policy makers believe will need to be considered in greater depth. ETHICAL ISSUES IN CAM RESEARCH Over the past 60 years the major sources for guidance on the ethics of research with human subjects in the United States have been the Nuremberg Code (1946), the Declaration of Helsinki (1964, revised in 1996), the Inter-

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Complementary and Alternative Medicine in the United States national Ethical Guidelines for Biomedical Research Involving Human Subjects (1982, revised in 1993), the Belmont Report of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (1979), and the federal Common Rule, (U.S. Department of Health and Human Services, 45 CFR 46, 1991). Emanuel and colleagues (2000) have proposed a consolidation and synthesis of the diverse principles and norms in these various codes and statements into seven requirements which, if satisfied, “make clinical research ethical.” Their synthesis provides a useful beginning point for considering the ethical challenges raised by CAM research. Social or Scientific Value The value of a research project is the extent to which it holds the promise of improving health or increasing knowledge important to health, when it is judged on either social or scientific grounds. Social or scientific value must be considered because resources available for research are scarce and should be expended wisely. It is also ethically imperative that subjects enrolled in clinical trials not be placed at risk except in the search for socially or scientifically important results. The placement of subjects at risk for an insignificant outcome is exploitation. Here the challenge for CAM research will be to select for investigation those therapies that have the greatest social or scientific significance. Yet, CAM therapies do not constitute a consistent or unified set of practices but constitute a wide-ranging set of highly variable practices, valued in different ways by the constituencies that deliver and receive them. This is a difference in degree, but not in kind, from the decisions that policy makers and researchers already face, for example, when they are faced with decisions about whether to fund more research on hypertension, cancer, or depression. Such decisions, however, may be more complex when CAM therapies are considered, precisely because there may be no common standard for adjudicating the relative value of various CAM therapies, except perhaps by recourse to conventional biomedical definitions and rankings of health and disease. Yet exclusive recourse to conventional definitions and rankings would challenge the commitment to pluralism. Thus, even in the selection of which CAM remedies to investigate, there is the need for negotiation about the relative social and scientific values of therapies. There is also a risk, common to many areas of medical research, that the commercial interest of providers and manufacturers will dominate over public interests and health needs (Hilts, 2003). Ensuring that social and scientific values prevail over commercial ones will be an ongoing ethical task.

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Complementary and Alternative Medicine in the United States Scientific Validity Validity results when scientific principles and methods are used to produce reliable outcomes. Ethically, the same considerations that endorse social or scientific value also underwrite scientific validity. Research that is underpowered, that does not have a testable hypothesis, or that cannot otherwise achieve its purpose is a waste of resources and constitutes the exploitation of human subjects, who are placed at risk for no beneficial purpose. For CAM research, it is important to ask about the range of scientific validity that is appropriate and what should count as a validated therapy. Because it entails social values, this is as much an ethical as an epistemological question. For example, should a “validated therapy” mean one that can be adequately explained in terms of the conventional biomedical model or, more simply, one that can be shown to provide benefit, even in the absence of a scientific explanation of its mechanism of action? Ethically, this presents a value-based choice between a more conventional scientific understanding of a validated CAM therapy and a more pragmatic stance that may not be consistent with current research standards for conventional medicine. In a parallel but slightly different context, regulations such as disciplinary provisions in medical licensing statues that divide the world of CAM therapies into such categories as “validated,” “invalidated,” and “nonvalidated” and do so partly in terms of theoretical “plausibility” should also be examined for both epistemological and ethical assumptions. Fair Subject Selection The ethical principle at play in fair subject selection is justice. Putting justice to work in clinical research means selecting subjects so that there is an equitable distribution of benefits and burdens. This means attending to the relative vulnerability of subjects for certain kinds of high-risk research, making sure that there is equity in subject selection along the lines of racial-ethnic socioeconomic status, gender, and other factors. More generally, fair subject selection means that those who bear the risks of research should be among those who reap the benefits and that those populations who enjoy the fruits of research should also share in the risks. There is no simple formula for how to achieve fair subject selection, but there are federal requirements both for protecting certain categories of vulnerable populations (e.g., pregnant women, children, and prisoners) and for including women and children unless they are inappropriate to the study. If CAM therapies generally were used predominantly by indigent populations or by certain ethnic or racial minorities, justice would require, other things being equal, that the subject populations be drawn from these groups and that these groups be among the first to receive whatever benefits were available

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Complementary and Alternative Medicine in the United States from any newly validated therapies. The United States has yet to enact policies that ensure justice in the distribution of the fruits of research, even for conventional medical research. The stipulation of such goals for CAM would be a good precedent, although awaiting the adoption of such standards of justice will require major policy changes and the absence of such standards should not delay research on CAM. Favorable Risk-Benefit Ratios The ethical norm of risk-benefit contains several principles, some of which were discussed above. These include the obligation to minimize risks to subjects during the trial (nonmaleficence), to enhance potential benefits (beneficence), and to ensure that the benefits to subjects or society, or both, are worth the risks incurred (proportionality and nonexploitation). For many CAM practices the absence of standardization among practitioners, combined with imprecise measures of outcomes, could make the risk-benefit ratio more difficult to assess when subjects are enrolled in a trial and thereby make the informed-consent process more vague and fragile. For example, many CAM therapies emphasize a concept of wellness that is more holistic and inclusive than typical outcomes research. Whether and how to include this more imprecise aspect of health into a clinical trial is a question of both epistemology and ethics, that is, both the research methodology and the ends that are valued and sought through research. Informed Consent Considered by many as the heart of research ethics, informed consent expresses the obligation of researchers to inform potential subjects of the purpose of research, its risks and benefits, along with the alternatives, in a manner that ensures that the participants understand these elements of research and can act freely to enroll or decline. Informed consent is one of the chief ways of promoting subject autonomy, or self-determination, which is the right of free choice based on one’s own values. Some of those designated as vulnerable in the federal Common Code are categorized as such precisely because of their diminished capacity to give consent. More generally, it is now well recognized that subjects who are ill and who participate in research in a clinical setting, often with their regular doctors acting as researchers, are likewise in a vulnerable position with regard to informed consent (Appelbaum et al., 1987; U.S. Advisory Committee on Human Radiation Experiments, 1996). Here the issue is not subjects’ mental capacities, but their expectations, with the subjects often attributing more therapeutic potential to a research project than the evidence or the trial design warrants. This has been termed the “therapeutic misconception,”

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Complementary and Alternative Medicine in the United States and it is a known hazard for both subjects and investigators, and perhaps also for others in the research process, such as sponsors and institutional review boards (IRBs) (Dresser, 2002; Henderson and King, 2003; Miller, 2000). It may be an especially vexing issue for trials involving CAM therapies, especially those CAM therapies that rely on the expectancy of patients or on close practitioner-patient relationships for a substantial part of their efficacy. In other words, working to correct the therapeutic misconception in clinical trials of CAM therapies may undermine precisely those elements of belief and expectancy on which some CAM therapies rely. Therefore, care should be taken to design protocols that can take account of this component of expectancy (without vitiating it). In this regard CAM therapies differ only in degree, and not in kind, from research with conventional remedies. Investigators and sponsors should be vigilant about expectancy factors in themselves, as well as in subjects and in the informed consent process as CAM therapies are tested. Independent Review Independent review means a review of the research design, subject population, risk-benefit ratio, and so forth, by persons with expertise in these facets of research and not affiliated with the trial in question. The aim here is to minimize conflicts of interests, ensure objectivity, and enhance public accountability. Independent review of CAM trials may pose challenges in terms of finding reviewers who are knowledgeable about the modalities under investigation and about research procedures and yet who are sufficiently disinterested about the outcomes. Respect for Potential and Enrolled Subjects This last, catchall category of respect incorporates several requirements: (1) permitting subject withdrawal from the research; (2) protecting subject privacy through confidentiality; (3) informing subjects of changes in risks and benefits during the trial; (4) making the research results available to the subjects of that research; and (5) generally, maintaining the welfare of the subjects throughout the trial. Here CAM therapies pose a potential issue of expertise in research oversight. Typically, IRBs consist of individuals with knowledge and expertise in conventional medicine modalities and research. Thus, it will be necessary to identify and recruit reviewers who have knowledge of CAM therapies and who are well versed in both the standard protocols and any innovative features involved in CAM protocols. Beyond these more particular areas for ethical inquiry, it is important to acknowledge the powerful role of social perceptions and values in shap-

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Complementary and Alternative Medicine in the United States care, referral to a more like-minded physician who can continue to monitor the patient is warranted (Adams et al., 2002). Although physicians should be clear about the ethical duty of nonabandonment, they should also “take the initiative to proactively steer the patient away from treatments that are known to be dangerous or have been associated with clinically significant adverse interactions with other supplements or medications” (Adams et al., 2002). Moreover, when there is no evidence either for or against a given CAM therapy, physicians “can choose to tolerate and monitor or actively discourage use of CAM treatments” (Adams et al., 2002; Cohen and Eisenberg, 2002). In so doing, physicians should consider such factors as the severity and acuteness of the illness; the manageability or curability of the illness by conventional forms of treatment; the degree of invasiveness, associated toxicities, and side effects of the conventional treatment; the availability and quality of evidence of the utility and safety of the desired CAM treatment; the level of understanding of the risks and benefits of the CAM treatment combined with the patient’s knowledge and voluntary acceptance of those risks; and the patient’s persistence of intention to use CAM therapies (Adams et al., 2002). By following this procedure, clinicians can formulate a plan that is “clinically sound, ethically appropriate, and targeted to the unique circumstances of individual patients” even in the absence of scientific evidence (Adams et al., 2002). The ensuing discussions between physicians and patients not only are the “heart of informed consent,” but also are “often the beginning rather than the ending” of the conversation (Adams et al., 2002). The best approach should take into consideration the unique circumstances of the individual patient. While some tension between medical pluralism and an evidence-based approach is likely inevitable and probably productive, the committee suggests that some of this tension can be resolved by CAM research and that the concept of evidence-based medicine will need to be modified to accommodate the multiple approaches inherent within a pluralistic understanding of health care. Finally, when a clinician decides whether to offer, recommend, discourage, or accept a patient’s use of CAM therapies or refer patients to CAM providers, ethical obligations and legal duties (or at least liability considerations) may diverge (Cohen, 2003). For instance, it may be legal, but perhaps not ethical, for a physician with minimum training in acupuncture to provide the patient such treatment (Cohen, 2003). Conversely, it may be ethically compelling, but legally risky, to have an unbiased discussion with a terminally ill patient who is suffering from an incurable brain tumor yet who is ineligible for available clinical trials and who is interested in trying a treatment not accepted as safe and effective by the Food and Drug Administration (Cohen, 2003; U.S. House of Representatives, 1996; United States v. Rutherford, 1979). In this situation the physician may face a conflict of

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Complementary and Alternative Medicine in the United States values or at least a worldview divergent from that of the patient, who may not share with the physician an understanding of the role and the value of scientific evidence (or the lack thereof) with the same intensity. Any collision of values requires sensitivity to the patient’s expression of interests that goes well beyond the legalistic requirements of informed consent, as well as attention to the malleable but important fabric of the therapeutic encounter. In this respect, the ethical commitment to medical pluralism should be considered as the physician wrestles with conversations involving patient decision making. Similarly, a physician may ethically support a patient’s stated desire to try yoga, colonics, or reiki for a limited period rather than surgery, yet the clinician might be concerned about potential liability if he or she accepts the patient’s choice (Adams et al., 2002). Alternatively, the clinician may be sensitive to the potential for unwarranted professional discipline, based on the use of therapies not generally accepted within the profession (Cohen, 1998). Likewise, a hospital administrator may wish to limit potential liability exposure by introducing only those CAM therapies that have been demonstrated to be safe and effective to the satisfaction of a hospital committee, the Food and Drug Administration, or a medical specialty group; yet ethically, denying patients access to a larger range of therapies could conceivably contravene interests in beneficence (e.g., by depriving patients of potential therapeutic benefit), justice (e.g., by ensuring access to therapies), and autonomy (e.g., respecting the patient’s interest in therapies and choice of treatment). As well, once a therapy becomes generally medically accepted, failure to provide adequate informed consent can result in potential malpractice liability (Ernst and Cohen, 2001; Moore v. Baker, 1993). On a broader level, legal and ethical issues often arise, and sometimes conflict, with CAM therapies because the decision facing a clinician (or institution) may engender a conflict between medical paternalism (the desire to protect patients from foolish or ill-informed, although voluntary, decisions) and patient autonomy (Cohen 1998, 2003). As suggested, the conflict between paternalism and autonomy can be accentuated by the patient’s selection of therapies that may, at the moment of choice, lack general medical acceptance or a sufficiently recognized evidentiary base (Cohen, 2003a). Whether strong paternalism—which would violate a patient’s informed, voluntary, and autonomous choice—is justified depends on a number of factors, including the possibility that the projected benefits of the paternalistic action will outweigh its risks to the patient and the possibility that the least autonomy-restrictive alternative that will secure the benefits and reduce the risks is selected (Beauchamp and Childress, 1994; Cohen, 1995, 1998). Yet, the exercise of strong paternalism should be a rare event (even if it is not so rare in practice), and patient autonomy (for competent adults) is the presumptive norm for all medical care. This is

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Complementary and Alternative Medicine in the United States because achieving genuine patient autonomy always involves information giving, discussion with the patient, and other enabling actions. Precisely because it involves dialogue on perspectives other than those of the provider, including interpreting the facts and probing the meaning of choices, autonomy for patients normally implies the best standard for medical decision making. The challenge for practitioners in achieving and honoring such autonomy may well be greater when patients are considering CAM therapies than when they are considering conventional medical therapies. Practitioners not only may have less information about CAM modalities, but they also may be uncomfortable in the discussion of CAM therapies, since information on CAM is often couched in more analogical and metaphorical language than the mechanistic cause-and-effect imagery typical of the remedies offered by conventional medicine. Regulatory structures increasingly acknowledge the need for weighing and balancing of differing standards. For example, Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice, promulgated by the Federation of State Medical Boards (FSMB, 2002), explicitly allow for “a wide latitude in physicians’ exercise of their professional judgment,” recognize that “patients have a right to seek any kind of care for their health problems,” and aim to create rules that are “clinically responsible and ethically appropriate.” Although the model guidelines as a whole may or may not balance or even explicitly address the five ethical commitments enumerated earlier, the quoted language at least establishes a greater balance between physician and patient preferences than has historically been supposed. Similarly states are considering whether revisions to their own medical disciplinary provisions require amendment to more appropriately balance one or more of the ethical commitments outlined earlier in this chapter. A number of legal rules also attempt to balance these competing interests and values and to protect patients by combating fraud and enhancing quality assurance while offering access to therapies and honoring medical pluralism in creating models of integrative care. Complex combinations of such rules may govern decisions by clinicians and health care institutions that seek to integrate CAM therapies into conventional medical settings (Cohen, 1998). In addition to informed consent, these rules include licensure and scope of practice, malpractice liability, professional discipline, food and drug law, health care fraud, and rules pertaining to third-party reimbursement (Cohen, 1998) and to spirituality in clinical settings (Cohen, 2003). These rules often work to elaborate and complement the five principal ethical commitments discussed at the beginning of this chapter: beneficence, nonmaleficence, protection and enablement of autonomy, medical pluralism, and public accountability. A brief discussion of these rules may be helpful, as they frequently dovetail with clinical decisions to recommend,

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Complementary and Alternative Medicine in the United States tolerate or accept, or discourage patient use of CAM therapies and visits to CAM providers (Cohen and Eisenberg, 2002). First, licensure is a matter of state law, since states have the power to license (or decline to license) any class of health care providers. This is because the Tenth Amendment to the U.S. Constitution provides that the powers not delegated to the federal government by the Constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people, and this reserved power includes regulation of health care licensure. In each state, the medical licensing statute (or medical practice act) prohibits the unlicensed practice of medicine, whereas other statutes license allied health professionals, such as nurses, physical therapists, and optometrists, and CAM providers such as chiropractors (Cohen, 1998; Eisenberg et al., 2002). Licensure varies by state and profession, and ranges from mandatory licensure to title licensure and registration of the providers with a state agency (Cohen, 1998). Many CAM-related professional organizations are developing national standards for examination and licensure and legally authorized scopes of practice boundaries, ethics, and clinical practice (Eisenberg et al., 2002). Encouraging the continuing development and enhancement of such standards can help facilitate “collaboration and referral; offer more authoritative, consistent, and generalizable clinical and financial research; minimize access to unqualified CAM providers; and help … hospital credentialing and … risk management” (Eisenberg et al., 2002). Yet, “greater homogeneity may undermine the diversity of education, training, and skill, which historically have characterized many CAM professions,” resulting in “excessive standardization, rigid scope of practice boundaries, excessive utilization standards … and fee schedules, increases in patient volume, decreases in individualization of services, a decrease in time spent per patient, and a perceived decrease in satisfaction by both patients and CAM practitioners” (Eisenberg et al., 2002). In any event, policies involving licensure, scope of practice and credentialing, and their relation to malpractice liability and risk management must be addressed creatively if health care institutions are to respond to patient interest in CAM therapies in ways that provide therapeutic benefit yet that satisfy liability concerns (Cohen and Ruggie, 2004). Malpractice liability and professional discipline are intertwined, as a claim of negligence against a clinician could trigger civil liability through the former mechanism and the loss of licensure or some other sanction through the latter. In Schneider v. Revici the patient sued Dr. Revici for malpractice using a nutritional protocol to treat cancer. Dr. Revici offered a successful defense against the charge on the basis of the fact that the patient had signed an assumption of risk form (Cohen and Eisenberg, 2002). The caveat to this is that not all states accept assumption of risk as a

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Complementary and Alternative Medicine in the United States defense, and its application can vary depending on the facts of the case. Likewise, a health care institution can be liable in malpractice cases for direct negligence (such as negligent credentialing or negligent failure to supervise a provider) or vicarious negligence (e.g., liability for the act of an employee or agent) (Cohen, 2000). Medical malpractice (negligence), whether it involves biomedical or CAM therapies, is generally defined as unskillful practice that fails to conform to a standard of care in the profession and that results in patient injury. CAM providers, like physicians and allied health care providers, can also be sued for negligence. The application of liability (or discipline) becomes problematic if a conventional-medicine clinician’s inclusion of CAM therapies is itself considered a deviation from prevailing and acceptable standards of care, as this could result in a conclusion of negligence, without necessarily finding evidence of wrongful conduct that caused patient injury (Cohen, 1999a,b, 2000). In Charell v. Gonzales the patient sued Dr. Gonzales for substituting a nutritional protocol for cancer care. The jury found Dr. Gonzales not only negligent but also reckless; however, the patient had implied consent to the protocol and, therefore, was deemed 49 percent responsible; liability was thus reduced accordingly (Cohen and Eisenberg, 2002). Once research establishes that a specific CAM therapy is within biomedical standards of care (e.g., the determination by a National Institutes of Health Consensus Panel that acupuncture is effective for the relief of nausea following chemotherapy [National Institutes of Health, 1997]), failure to recommend (or refer a patient for) such a therapy potentially could be considered malpractice (or could lead to professional discipline) if it results in patient injury (Cohen, 1998). In the case of Moore v. Baker (1993), a patient who received cardiac bypass surgery sued for malpractice, alleging inadequate informed consent because of the physician’s failure to disclose the possibility of EDTA (ethylenediaminetetraacetic acid) chelation therapy as a less invasive alternative. The 11th Circuit Court held that if EDTA chelation therapy were generally accepted within the medical community, the patient might have an actionable claim. As part of malpractice law, a nonphysician (whether he or she is an allied health care or CAM provider) has a legal (and ethical) duty to refer the patient to a medical doctor if the patient’s condition exceeds the provider’s training, skill, and competence or is not responding to the nonmedical treatment (Cohen, 1998). Similarly, the provider who makes a grossly exaggerated claim that induces reliance on a particular therapy potentially could be liable for fraud or misrepresentation (Cohen, 1998). Such legal rules frequently correspond with ethical provisions in the codes of some CAM professions and help protect patients against overzealous or overreaching practitioners (Cohen, 1998, 2000). It may be helpful for physicians to remember that CAM providers have a legal and ethical duty to

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Complementary and Alternative Medicine in the United States refer a patient for conventional medical care when the patient’s condition requires such referral. Regarding referrals to CAM providers, the general legal rule is that physicians are not liable merely for referring the patient to another provider—whether that provider is a conventional medical or CAM practitioner—who turns out to be negligent. On the other hand, physician liability for “joint treatment” of the patient with a CAM provider, one notable exception to the general legal rule, may expand as integrative care results in greater coordination between biomedical and CAM providers (Cohen and Eisenberg, 2002) and the level of “claims consciousness” by patients of CAM providers increases (Studdert et al., 1998). Although such liability considerations continue to be unsettled, they should not necessarily preclude clinically sensible referrals, based on an awareness of what CAM providers can and cannot offer the patient, and a shared conversation regarding the objectives (and limits) of any one form of care (Cohen and Eisenberg, 2002). Such conversations, indeed, can help further a more pluralistic vision of health care, while offering the physician sufficient information to help navigate unwarranted liability concerns. Although clinicians and institutions can continue to be guided by considerations of safety and efficacy (Cohen and Eisenberg, 2002), as well as relevant ethical considerations (Adams et al., 2002), legal rules and institutions may continue to grow in their understanding of integrative health care practices as the field emerges. Another emerging area, food and drug law, is complex and exists at the state as well as federal level. It also impacts the balance between paternalism and autonomy interest, as well the ethical commitment to medical pluralism. For example, Congress, in enacting the Dietary Supplement Health and Education Act (DSHEA), observed that the federal government “should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers” (DSHEA, 1994). The DSHEA has received extensive criticism within the medical community for leaving consumers without sufficiently accurate disclosure to make informed decisions regarding herbal products. A secondary criticism has been that the DSHEA allows patients to purchase medicinal substances without prior proof of safety or efficacy. Such criticisms are warranted and have led to calls for increased vigilance—and regulation—to help ensure product safety. At the same time, however, the DSHEA expressly articulates a public policy tilt by the Congress, in the domain of dietary supplements, toward consumer autonomy and away from government regulation. Future regulation concerning dietary supplements should account for all the ethical commitments articulated earlier, balancing the interests of competing stakeholders and better accounting for

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Complementary and Alternative Medicine in the United States public safety, while enhancing the disclosure necessary to facilitate informed, autonomous choices. Health care fraud, another important area of legal concern, also is embedded in both federal and a variety of state statutes (such as consumer fraud laws), both civil and criminal, and common-law rules (such as the proscription against misrepresentation). Legally, fraud requires deception as well as the intent to deceive (Cohen, 1995). The concern for fraud pervades regulation of CAM therapies and, indeed, was part of the early rationale for physician licensure (Cohen, 2003). Yet, because the label of “fraud” often has been concluded rather than proven by law and evidence, Congress (in legislative history) has clarified in at least one context—submission of claims for reimbursement by federal and other funds—that the practice of CAM therapies “itself would not constitute fraud” (Report, 1996). Of course, if a practitioner engages in conduct that exploits patients or unjustifiably diverts them from necessary conventional care, such conduct may lead to malpractice liability, professional discipline, or other legal action, even if not necessarily actionable or fraud. Third-party reimbursement also implicates legal rules, as notions of “medical necessity” and what constitutes “experimental treatments” may change as integrative health care unfolds (Cohen, 1998). Finally, the use of spirituality in clinical settings, whether through biomedical or CAM therapies, also implicates liability and other legal as well as ethical considerations (Cohen, 2003) and requires sensitivity, professionalism, and care to ensure that patients are offered opportunities to draw on spiritual support without being unduly coerced thereby (Koenig, 2002; Cohen, 2003). Once again, considerations of spirituality in clinical settings should be guided by considerations of nonmaleficence, beneficence, autonomy, pluralism, and accountability. Notably, in reviewing the complex interaction of preeminent ethical commitments and relevant legal rules, the existing legal and regulatory framework emerged from late-nineteenth century rivalries between the “regular” physicians and their economic and ideological competitors (mainly, chiropractors and homeopaths) in the provision of health care services (Kaptchuk and Eisenberg, 2001; Rothstein, 1972; Shryock, 1967; Stevens, 1971; Starr, 1982). These sectarian rivalries shaped a regulatory environment in which CAM providers often struggled for legal acceptance, and in which CAM providers, and physicians utilizing CAM therapies, found varying levels of regulatory oversight and tolerance (Cohen, 1998). A more balanced perspective must incorporate notions of medical pluralism (Kaptchuk and Eisenberg, 2001) in a way that assures more unbiased consideration of other medical traditions and enables more complete representation by consumers and the various professional groups. In sum, to the extent that the medical, social, political, and public health environments are

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Complementary and Alternative Medicine in the United States changing, legal and regulatory structures also are changing and may further evolve (Cohen, 2000; Callahan, 2002; Cohen, 2003). The sectarian rivalries that have shaped the regulatory and legal environment have also been at play in the formation of conventional medicine’s ethical precepts. Medicine is and has always been permeated with the culture and values of its time and place, and hence is constantly shaping and being shaped by the larger social, cultural, and political forces of its era. The history of medical ethics over the past 2,500 years is vivid testimony to the ways this has occurred. The prevalence and persistence of CAM therapies is another juncture in this evolution. Without rejecting what has been of great value and service in the past, it is important that ethical norms are brought under critical scrutiny and evolve, along with medicine’s expanding knowledge base and the larger social aims and meanings of medical practice. REFERENCES AANP (American Association of Naturopathic Physicians). 1990. Naturopathic Code of Ethics. [Online]. Available at: http://www.naturopathic.org/positions/ethics.html [accessed June 17, 2004]. ACA (American Chiropractic Association). 1996. Code of Ethics. [Online]. Available at: http://www.acatoday.com/about/ethics.shtml [accessed June 17, 2004]. Adams KE, Cohen MH, Eisenberg D, Jonsen AR. 2002. Ethical considerations of complementary and alternative medical therapies in conventional medical settings. Ann Intern Med 137(8):660–664. American College of Physicians, Ad Hoc Committee on Medical Ethics. 1998. Kitchens LW, Snyder L, Morin K, eds. Ethics Manual. 4th ed. Philadelphia, PA: American College of Physicians. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. 1987. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep 17(2):20–24. Astin JA. 1998. Why patients use alternative medicine: Results of a national study. JAMA 279(19):1548–1553. Astin JA, Astin AW. 2002. An integral approach to medicine. Alternative Therapies in Health & Medicine 8(2):70–75. Beauchamp TL, Childress JF. 1994. Principles of Biomedical Ethics. 4th ed. New York: Oxford University Press. Bratman S. 1997. Alternative medicine: How well does it live up to its own ideals? Altern Ther Health Med 3(6):128, 127. Brody H. 2002. The placebo effect: Implications for the Study and Practice of Complementary and Alternative Medicine. In: Callahan D, ed. The Role of Complementary and Alternative Medicine: Accommodating Pluralism. Washington, DC: Georgetown University Press. Pp. 74–83. Callahan D. 1996. Specifying the goals of medicine. Hastings Center Report supplement:(9–14). Callahan D. 2002. The Role of Complementary and Alternative Medicine Accommodating Pluralism. Washington, DC: Georgetown University Press. Churchill LR. 1995. Beneficience. In: Reich WT, ed. Encyclopedia of Bioethics. Vol. 1. Revised ed. New York: Simon & Schuster, McMillan. Pp. 243–247.

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