Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical, and Clinical Issues in Decision-Making

DEFINING CAM

Defining CAM is difficult, particularly because of the wide range of different therapies, products, and approaches to healing that the term encompasses. For the purposes of this study, we have adopted the definition of CAM offered by the US Office of Alternative Medicine CAM Research Methodology Group, which is also used by the Cochrane Collaboration: “Complementary and alternative medicine is a broad domain of healing resources that encompasses all health care systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. CAM includes all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being. Boundaries within CAM and between the CAM domain and that of the dominant system are not always sharp or fixed.”⁹

Other definitions of CAM, such as that used by the National Center for Complementary and Alternative Medicine (a component of the National Institutes of Health in the United States) and the one adopted by the Institute of Medicine in its 2005 report on CAM, have considerable currency as well.^10,11

However, this definition, which was adopted by major reports on CAM in Canada, and in the United States and elsewhere,^12,–,16 has a number of advantages. It is broad enough to encompass both CAM practices and products. It moves beyond early efforts to define CAM in terms of medical interventions that are neither taught in medical schools nor available in hospitals^17,18; the increasing use of CAM and its introduction into some medical schools' curricula^19,20 diminish the utility of such a definition. In addition, this definition acknowledges the role played by political, social, cultural, and historical forces, which can exert a powerful influence on determinations about what is considered acceptable within a health care system. It also recognizes that boundaries between CAM and conventional medicine are fluid and that as a given CAM therapy gains research acceptance and clinical use, it may move into the medical mainstream.

OVERVIEW: THE CASE SCENARIOS

In this supplemental issue of Pediatrics, we present the results of our research as a series of 8 case scenarios and commentaries. The scenarios were developed to act as a practical anchor in the exploration of CAM policy issues and to illustrate the application of and shortcomings in existing guidance and intervention principles. These case scenarios deliberately involve a range of ages (infant to adolescent), clinical conditions (acute to chronic, health prevention and promotion to treatment of specific illnesses), settings (outpatient and inpatient), and levels of care (primary care and consultation) to more fully explore the impact of current guidelines, principles, and law.

The case scenarios address the following issues and areas of focus:

• physician/parent conflict about care (vaccination):

• clinician and patient/parental responsibilities to take CAM into account (natural health product/drug interactions);

• adolescent decision-making and parent/child conflict (CAM alternative to conventional treatment);

• informed consent when CAM could complement conventional care (chemotherapy-induced nausea);

• hospital policies about CAM;

• determining best interests of the child, limits on parental decision-making authority (life-threatening illness), and CAM as an alternative treatment;

• managing referrals to and shared or collaborative care with CAM practitioners (condition unresponsive to conventional treatment); and

• CAM practitioners' standard of care (diagnosis, monitoring, referral).

In this introductory article we briefly review the underlying ethical and legal principles and then outline general considerations in clinical decision-making.

ETHICAL PRINCIPLES

The bioethics literature frequently considers issues in health care treatment decision-making for children, but primarily in the context of conventional care. Issues may be categorized as those related to (1) who the appropriate decision-makers are (eg, parents, health care professionals, the child), (2) according to what ethical principles, standards, and rules decisions ought to be made, and (3) special obligations of physicians. Although there has not been an extensive addition to the pediatric bioethics literature addressing issues specifically related to CAM and children, there have been some attempts to identify relevant ethical issues and analyze them in light of existing models.^21,22

LAW: SETTING STANDARDS AND ESTABLISHING LIABILITY

CAM use has seldom led to litigation. Legal analysis in this project was informed by the few cases of relevant judicial decisions, but most often, the issues had not yet been considered by courts in the context of CAM, and general legal principles provided the starting point for analysis. Judicial decisions not only determine liability for harm caused by deficient care but also, together with statutory and regulatory regimes, set legal standards that practitioners and health facilities must meet. Most lawsuits about health care are based on allegations of negligence (ie, claims that providers failed to meet the applicable standard of care and caused harm). Depending on factual circumstances, claims for battery, breach of contract, and breach of fiduciary duty may also be advanced.

Because they are the most common, we focused on civil lawsuits that allege negligence. To succeed in a negligence claim, a plaintiff must prove on a balance of probabilities that (1) the health care provider owed him or her a duty of care, (2) the provider breached the legal standard of care, (3) the provider's breach caused injury or loss to the plaintiff, and (4) the plaintiff's damages are not too remote to be recoverable in law. Liability can arise from substandard care and from a failure to obtain informed consent to treatment.

In addition to civil liability, regulated health professionals can be subject to disciplinary proceedings and sanctioned by their governing bodies for professional misconduct if they fail to maintain standards of practice.^43,–,47 Finally, all health care providers are bound by laws of general application, including criminal law, consumer-protection laws, and laws that prohibit unauthorized provision of health services.^48,–,51

CLINICAL CONSIDERATIONS

Relatively limited research on the efficacy and safety of CAM, especially in children, means that decisions must frequently be made in conditions of uncertainty. As with conventional therapies, even when risks and benefits are known, practitioners, parents, and patients may weigh them differently. Decisions are to be made in the child's best interests, but these interests may be contentious, especially if conventional treatment offers few or uncertain benefits or has serious adverse effects. Consequently, decision-makers (parents, providers, and institutions) are often left in a quandary. Disputes may arise about who can decide, the latitude allowed decision-makers (primarily parents in the first instance), when institutional or state intervention is appropriate, and how decisions should be made. For health care facilities, questions arise about how to respond to increasing use of and growing demand for CAM by patients and families.

When considering what advice to give about using CAM, some authors have suggested a framework to guide decision-making based on available evidence of safety and efficacy: “If evidence supports both safety and efficacy, the physician should recommend the therapy but continue to monitor the patient conventionally. If evidence supports safety but is inconclusive about efficacy, the treatment should be cautiously tolerated and monitored for effectiveness. If evidence supports efficacy but is inconclusive about safety, the therapy still could be tolerated and monitored closely for safety. Finally, therapies for which evidence indicates either serious risk or inefficacy obviously should be avoided and patients actively discouraged from pursuing such a course of treatment.”^52(p662)

This framework can be helpful when there is adequate reliable evidence,⁵³ but it is less helpful when evidence is lacking or limited, as is often the case with CAM.^52(p660) In addition, formulating a treatment plan generally entails weighing alternatives; treatment is not assessed in a vacuum. Balancing known risks and benefits of conventional therapies with unknown risks and benefits of CAM therapies poses significant challenges. Information about the safety and efficacy of CAM therapies is increasing all the time, but there are still large gaps in knowledge. Uncertainty is compounded by disagreements about the level and reliability of evidence needed. Decision-making in conditions of uncertainty is not uncommon in health care, especially in pediatrics, and it is not unique to CAM. Conventional therapies, too, may not have not been fully assessed, or at least not in similarly complex circumstances (eg, a child on multiple therapies or with concurrent morbidities). However, the lack of evidence about many CAM therapies and products can make assessing CAM options particularly difficult. Thus, although the framework can assist decision-making, the questions that remain outstanding often require a return to first principles in decision-making.