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Integration of divergent philosophies, paradigms, and practices requires responsible investigation, informed judgment, and open-minded yet critical study and analysis of various systems of healing. Michael H. Cohen offers providers and policymakers vitally important information by addressing questions such as credentialing, malpractice, informed consent, and liability for referrals. He describes both practical strategies for minimizing liability, as well as the necessary future evolution of the legal and regulatory structure.
Cohen also probes uncharted ethical and bioethical issues in complementary medicine and integrative health care. He further explores the connection between law, medicine, and spirituality and the role of this connection in human evolution. The book's range mirrors the integrative process itself, a process of grappling with, and meaningfully assimilating, disparate traditions and unfamiliar ways of thinking about the significance of health, body, and being.
Beyond Complementary Medicine is required reading for anyone involved in health care, including executives, insurers, managed care organizations, attorneys, ethicists, and lawmakers; physicians integrating complementary and alternative therapies; complementary and alternative medicine practitioners; medical schools, law schools, and educational institutions offering programs in health care, public health, and complementary therapies; companies manufacturing herbs and dietary supplements; and most of all, patients and their families.
Michael H. Cohen is President of the Institute for Integrative and Energy Medicine, a nonprofit organization in health care policy, ethics, and legal and regulatory affairs, and an attorney with an international practice in integrative health care.
Legal and regulatory structures governing complementary and alter- native medicine emerged out of the sectarian factionalism, competition, and professional monopolies of the nineteenth and twentieth centuries. Expulsion of nonconforming providers from medical societies, public campaigns against such "irregular" practitioners, ethical codes forbidding association and consultation with these providers, and the establishment of the American Medical Association as the dominant voice in U.S. health care all contributed to the suppression or decline of health care practices outside the stream of scientific medicine (or biomedicine). These activities coincided with the rise of regulation insulating the "regular" physicians from their economic and philosophical competitors through medical licensure.
The medical licensing laws, ostensibly aimed solely at protecting the public from untrained physicians, ensured that only those meeting the criteria set by practitioners of scientific medicine could legally practice. All others-such as naturopaths, homeopaths, chiropractors, massage therapists, and even spiritual healers-could be prosecuted under these laws and jailed for practicing "medicine" without a license. Biomedicine thus established legal as well as political dominance, and it suppressed rivals through enforcement of the regulatory structures it had encouraged or created.
By the early twentieth century, "Go to jail for chiropractic!" was a popular slogan for the profession, and chiropractors earned political mileage largely by performing spinal manipulations on fellow prisoners, on their wardens, and, upon release from prison, on legislators. Other providers were less successful in achieving legislative recognition, and although naturopaths, acupuncturists, massage therapists, and others ultimately earned licensure in many states, prosecution for the unlicensed medical practice of such diverse providers as midwives, hypnotherapists, iridologists, and even those offering such services as ear piercing and tattooing continued well into the end of the twentieth century.
Most medical practice acts have provided limited exemptions for those engaged in healing services of a religious nature. The exemption, however, typically has been limited to those practicing under the tenets of an established church and has not been extended to complementary and alternative medicine providers. Indeed, some claims by providers purporting to be practicing "religion" rather than "medicine" have been rejected, on the grounds that patients have come seeking health improvement and that the concepts of "diagnosis" and "treatment" in the definition of practicing "medicine" are broad enough to encompass such providers. Moreover, while spirituality plays an important role in many complementary and alternative medicine therapies, typically it is neither necessary nor appropriate to relegate a specific therapy or complementary and alternative medicine in general to the realm of belief (religion) rather than health care.
The law provides no standard definition of the term complementary and alternative medicine. No court or legislature has defined the practice of complementary and alternative medicine or set its legal parameters and boundaries generally. Rather, individual groups of providers are subject to different licensing laws, and providers and practices fall within several interlocking areas of law. While there has been no systematic attempt to bring unity and coherence to these different aspects of regulation, debates have continued regarding the appropriateness and efficacy of credentialing rules and other methods of regulating various complementary and alternative medicine providers.
Three levels of analysis can help frame the assessment of any form of regulation or policy relevant to clinical integration of complementary and alternative medicine. The first is paradigmatic: how do these diagnostic and therapeutic systems fit into health care as a whole? How do we assess safety and efficacy, when some therapies lack the kind of rigorous research base to which we are accustomed, while some even challenge conventional paradigms? More important, how do, or how should, these methodological and paradigmatic issues affect regulatory perspectives, such as the desire for reliable credentialing?
The second level involves consumer protection concerns. Typically, legal rules have been concerned with preventing fraud, abuse, and mistreatment of patients who trust in therapies outside biomedicine. Can this goal be achieved while still permitting appropriate clinical exploration of complementary and alternative therapies and keeping the patient's best interest in mind? Does existing law satisfactorily control dangerous or deviant practitioners, or does it stifle health care freedom and the health care system's ability to adapt and innovate to changing perceptions of disease and health? In general, should regulatory controls be loosened or tightened? To what extent should legal rules grant less deference to medical paternalism-the notion that patients must be protected against their own ill-advised choices? To what extent does the advent of complementary and alternative medicine herald a final shift from paternalism toward the recognition of deep autonomy as an important and countervailing, if not overarching, value?
The third level deals with the evolution of legal authority. How are courts and legislatures handling the integration of complementary and alternative medicine into mainstream health care? How can they continue to protect patients from dangerous practitioners and treatments yet allow access to a fuller range of therapies than conventional medicine to date has found comfortable?
These three levels of analysis can begin to open some of the ethical, legal, and even perceptual issues arising when health care paradigms of different cultures and subcultures clash. While these questions are pertinent to each area of law, this chapter focuses on the credentialing process for nonphysician providers of complementary and alternative medicine.
Regulators increasingly have looked to provider credentialing, primarily through state licensure, as a means of ensuring that health care professionals outside the biomedical paradigm have sufficient levels of training and competency to provide the public with safe, effective, and appropriate health care services. Adequate credentialing gives assurance to regulators as well as health care executives, insurance companies, clinicians, and patients that such providers have authority and capability to practice within definitely circumscribed, legally sanctioned boundaries. The effectiveness and appropriateness of such regulatory controls, however, must be scrutinized in the context of a larger shift from a health care system based on biomedicine to one moving toward integration of complementary and alternative medicine.
Shifting Paradigms and Regulatory Values
With its emphasis on standardized, quantifiable, objectively validated methods of diagnosis and treatment, the biomedical orientation toward health and disease has been characterized by mechanism-the notion of the body as a machine composed of separate parts-and reductionism, the reduction of illness to a set of physical symptoms. Mechanism and reductionism tend to separate diagnosis and treatment from the patient's subjective and social experience of disease, distance patient from caregiver, and sever personal meaning from the process of healing. On the whole, complementary and alternative therapies aim toward an opposite ideal, holism. This view attempts to account for patients as whole persons, exercising autonomous choices and seeking health in terms of a larger pursuit toward an irreducible, unified, physical, emotional, mental, and spiritual wholeness.
Although biomedicine historically regarded usage of complementary and alternative medicine as marginal or fringe, a 1993 study in the New England Journal of Medicine challenged this assumption, reporting that one American out of every three uses complementary and alternative medicine. Five years after this survey, a 1998 Landmark Healthcare study showed the figure was up to 42 percent of Americans; the 40 percent range was confirmed in a follow-up survey to the 1993 study. A follow-up to the Journal study revealed a 47.3 percent increase in total visits to complementary and alternative medicine practitioners, from 427 million in 1990 to 629 million in 1997, with total 1997 out-of-pocket expenditures relating to alternative therapies estimated at 27.0 billion dollars. The study suggested that use of complementary and alternative medicine is likely to continue to increase, particularly as insurance reimbursement for alternative therapies grows. Further, the study suggested that complementary and alternative therapies displace biomedicine, or at least become the preferred first route of diagnosis and treatment, for many patients with chronic disease, back problems, anxiety and depression, and other conditions.
These and other surveys have demonstrated that attitudes that dominated medical control of regulatory and reimbursement structures in the twentieth century no longer accord with patient values, attitudes, beliefs, and desires. Medical sectarianism no longer provides an adequate model for regulation of health in this country, and the notion that extreme medical paternalism should dominate legal rules and liability surrounding, as well as patient access to, therapies outside of biomedicine is anachronistic. Moreover, such paternalism demonstrates medical chauvinism: worldwide, some 80 percent of the world's population relies on non-Western, "traditional medicine" (such as acupuncture and traditional oriental medicine, Ayurvedic medicine, and folk medicine) and considers biomedicine to be "alternative" health care. To respect the patient, as person, the legal system, like medicine, must engage with paradigms beyond mechanism and reductionism and move toward a holistic understanding of the human being's journey toward health on all levels.
Legal authority can draw on efforts within the government and health care communities to obtain a fuller understanding of complementary and alternative medicine than has been traditionally canvassed. One foundational effort occurred during a meeting of leaders of complementary and alternative medicine in 1992, which culminated in the publication of what has come to be known as the Chantilly Report, a document bearing the parenthetical subtitle A Report to the National Institutes of Health on Alternative Medical Systems and Practices in the United States.
Although the report is not definitive, it represents a preliminary, quasi-governmental effort to systematically catalog fields of practice for complementary and alternative medicine. The seven major fields (and some of the subfields) include (1) mind-body interventions (including psychotherapy, support groups, meditation, imagery, hypnosis, biofeedback, yoga, dance therapy, music therapy, art therapy, and prayer and mental healing); (2) bioelectromagnetics applications in medicine (including applications of nonthermal, nonionizing electro-magnetic fields for bone repair, nerve stimulation, wound healing, treatment of osteoarthritis, electroacupuncture, tissue regeneration, immune system stimulation, and neuroendocrine modulations); (3) alternative systems of medical practice (including home health care, traditional oriental medicine, acupuncture, Ayurveda, homeopathic medicine, anthroposophically extended medicine, naturopathic medicine, environmental medicine, Native American medicine, and Latin American community-based practices); (4) manual healing methods (including osteopathic medicine, chiropractic science, massage therapy, and biofield therapeutics); (5) pharmacological and biological treatments not yet accepted by mainstream medicine (including anti-neoplastons, cartilage products, EDTA chelation therapy, and immunoaugmentative therapy); (6) herbal medicine (including European phytomedicines, Chinese herbal remedies, Ayurvedic herbal medicines, and Native American herbal medicines); and (7) treatments focusing on diet and nutrition in the prevention and treatment of chronic disease. Chapter 6 will reexamine this classification by using the concept of the biofield (here in category 4, under manual healing) as a unifying concept for some of the groupings.
While addressing some of the complex methodological issues involved in researching such therapies, the Chantilly Report's detailed exploration of these therapies also suggested the difficulty that legal authority must encounter in generalizing regarding proof, efficacy, and overall relevance to prevention and treatment of disease. The report noted that while many therapies are backed by solid research, some therapies continue to challenge conventionally accepted models of health and disease or even purport to render conventional categories dubious. As one example, according to Chinese medicine, chi circulates through channels in the body known as "meridians," yet the meridians have no known anatomical counterpart in Western science. Even if some anatomical correlations can be found or appropriate mechanisms of action adduced, theories of chi are not expressed in Western terms and purport to transcend mechanistic and reductionistic explanations of acupuncture's effects. Although traditional oriental medicine has earned legislative recognition by virtue of organized lobbying in many states, acupuncture has not received general medical acceptance beyond a narrow range of uses; the legislatively authorized scope of practice varies widely across the states; and many licensing statutes require referral from or supervision by a medical doctor in order for the patient to receive acupuncture and other traditional oriental medicine modalities.
A second example comes from Tibetan medicine. Tibetan physicians place little emphasis on Western scientific methods of analysis, technology, and proof, but Western physicians have little awareness of Tibetan knowledge of subtle energies and the role of consciousness in the creation and maintenance of health. Thus, at the outset, the clash in culture and temperament raises barriers to the possibility of dialogue, then research, then acceptance, and finally, integration. The more estoteric therapies within complementary and alternative medicine face significant hurdles when judged by the standards of biomedicine. Ethnocentrism is particularly acute when dealing with such a foreign medical tradition as Tibet's-yet this is one world medical tradition against whose longevity biomedicine seems hardly a blip on the screen.
While a Western scientist might attempt to match a Tibetan doctor's pulse and tongue diagnosis against a diagnosis made with sophisticated modern instrumentation-assuming a translation of disease categories is possible-much of Tibetan medicine remains esoteric, mysterious, and impervious to mechanistic, conventional explanations. For instance, the Tibetan Book of the Dead is written as a manual for how to help the soul on its journey immediately following death. Although Western scientists may consider this unprovable religion, Tibetans view the book as a code or protocol, establishing specific steps for postdeath care as an integral part of their medicine.
Therapies that challenge Western medical convention raise an important question for regulatory bodies: should the regulatory system solely be based on the evaluation of these therapies by dominant medical communities and scientific paradigms? Or should regulatory bodies take into account the historical, economic, political, and paradigmatic differences between these various systems and providers? Moreover, to what extent should paradigmatically foreign therapies and biomedicine's unreadiness, inability-or outright lack of competence-to comprehend such therapies influence legal rules and regulatory structures? For example, what light can Tibetan medicine's views of immediate postdeath procedures shed on legal rules governing end-of-life decision making or even on such seemingly mundane details as how many days the corpse should be left in the hospital bed before being disturbed? Such questions frame legal and ethical explorations in this chapter and in succeeding chapters.
Excerpted from Beyond Complementary Medicine by Michael H. Cohen
Copyright © 2000 by University of Michigan . Excerpted by permission.
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