Foreword

Preface

Executive Summary

Major Contributors

Foreword

The Office of Alternative Medicine (OAM) was established in 1991, with the appropriation of $2 million for an office "to more adequately explore unconventional medical practices." The Senate Appropriations Committee report acknowledged that "many routine and effective medical procedures now considered commonplace were once considered unconventional and counterindicated. Cancer radiation therapy is such a procedure that is now commonplace but once was considered to be quackery."


One of the first goals of the OAM was to develop a baseline of information on the state of alternative medicine in the United States. To accomplish this, a series of workshops were held in 1992. The first, a public meeting on June 17-18 in Bethesda, Maryland, included presentations from more than 80 speakers who detailed issues and concerns of importance to the alternative medicine community. On September 14-16, a second workshop was convened in Chantilly, Virginia, with a total of more than 200 participants who discussed the state of the art of the major areas of alternative medicine and to direct attention to priority areas for potential future research activities. Cochairs of the workshop working groups organized writing teams to collect and synthesize the available research in their respective fields and to develop recommendations to the National Institutes of Health (NIH).


This document represents the report of these meetings to the NIH, and includes the input of more than 200 practitioners and researchers of alternative medicine from throughout the United States. The hard work of the speakers, panel members, authors of working papers, and editors in putting this report together is gratefully acknowledged.


As the Office of Alternative Medicine proceeds to carry out its congressional mandate, the recommendations for future research in the report will be carefully considered. However, it should be pointed out that this document does not reflect endorsement of these therapies or recommendations for research by the NIH, the U.S. Public Health Service, or the U.S. Department of Health and Human Services. It reports on a series of opinions expressed by nongovernment participants in the workshops described above and is published for the purpose of furthering the dialogue between the alternative-complementary medicine communities and the biomedical research establishment.


The NIH cautions readers not to seek the therapies described in this document for serious health problems without consultation with a licensed physician. The NIH further cautions that many of the therapies described have not been subjected to rigorous scientific investigation to prove safety or efficacy; and many have not been approved by the U.S. Food and Drug Administration.

Preface

Because of the increasing sophistication of the U.S. health care system, its increasing administrative costs, and the exponentially expanding degree of training and specialization required by the health care practitioners who administer it, health care costs in this country have skyrocketed in the past few decades. Indeed, in 1940, health care absorbed $4 billion, a mere 4 percent of the U.S. gross national product (GNP); by 1992, health care costs had ballooned to more than $800 billion, or almost 14 percent of GNP._ Experts predict these costs will exceed $1 trillion this year.


Despite these expenditures, many Americans currently have little or no access to adequate health care. In fact, 37 million Americans have no health insurance at all; another 22 million have inadequate health care coverage. To increase access to basic health care, individuals and organizations from many sectors of society are now calling for reform of the present health care system. To date, this debate has focused mainly on making the current system less expensive through capping the amount of damages that can be awarded because of medical malpractice, limiting physician and hospital fees, further regulating the pharmaceutical companies, and controlling the misuse of health insurance.


Unfortunately, this debate has failed to take into account the fact that the current health care crisis is primarily a crisis of chronic disease. Today almost 33 million Americans are functionally limited in their daily activities by chronic, debilitating conditions such as arthritis, allergies, pain, hypertension, cancer, depression, cardiovascular disease, and digestive problems. More than 9 million, or almost one-third, of these individuals have limitations so severe that they cannot work, attend school, or maintain a household. The U.S. Public Health Service (PHS) estimates that 70 percent of the current health care budget is spent on the treatment of these individuals; as the population grows older, such conditions will continue to consume an even larger proportion of national health care expenditures. Furthermore, the worldwide pandemic of acquired immunodeficiency syndrome is threatening to completely overwhelm the health care delivery systems in certain areas of the United States.


While the dominant system of health care in the United States--often called "conventional medicine," or biomedicine--is extremely effective for treating infectious diseases and traumatic injuries, it is often ill equipped to handle complex, multifaceted chronic conditions. One reason is that over the years, conventional medicine has increasingly emphasized finding a single "magic bullet" solution for each condition or disease it confronts. The reality is that many chronic conditions are not amenable to such one-dimensional solutions.


Rather, such complex conditions require equally multifaceted treatment approaches. Furthermore, it is far less expensive to prevent them from occurring in the first place than to attempt to treat the symptoms and consequences with surgery and expensive drugs, which often offer only short-term solutions. For example, coronary artery disease affects approximately 7 million Americans and causes about 1.5 million heart attacks and 500,000 deaths a year. Approximately 300,000 coronary artery bypass graft operations are performed in the United States each year at a cost of about $30,000 each, or $9 billion total. Yet coronary artery bypass surgery prevents premature death in only a few patients with the most serious main coronary or multiple-vessel heart disease. On the other hand, heart disease is almost entirely attributable to poor diet (i.e., high fat intake) and unhealthy lifestyle decisions (alcohol consumption and smoking), and thus can be avoided. For those who already have heart disease, an extremely low-fat diet combined with exercise and other therapies may actually start unclogging blocked arteries and significantly extend life.


Thus, for health care reform truly to succeed at reducing costs and increasing access, disease prevention must be the ultimate focus of the primary health care system rather than disease treatment. This change in emphasis can be accomplished only by restructuring the current system so that people learn that they are far better off staying healthy than relying on high technology to rescue them from a lifetime of unhealthy living. In addition, to care adequately and cost-effectively for those who already have chronic illnesses, health care reform must incorporate multifaceted approaches to the treatment of these patients, approaches that control the symptoms while alleviating the underlying causes.


In 1990, PHS recognized the need to completely revamp the current approach to health and illness when it released a 700-page report called Healthy People 2000. This report enumerated the challenges and goals for improving the Nation's collective health by the year 2000 and challenged the Nation to move beyond merely saving lives. It explained that "the health of a people is measured by more than death rates. Good health comes from reducing unnecessary suffering, illness, and disability. It comes from an improved quality of life. Health is thus measured by citizens' sense of well-being. The health of a Nation is measured by the extent to which the gains are accomplished for all the people." To reach this goal, the report called for "mobilizing the considerable energies and creativity of the Nation in the interest of disease prevention and health promotion" as an economic imperative.


This report was developed in the spirit of Healthy People 2000. Its purpose is to investigate which "alternative" health care options might best be mobilized to help in the fight against the major diseases and conditions that are robbing so many Americans of their quality of life. The individuals who helped write it comprised members of systems of medicine and therapies that emphasize improving quality of life, disease prevention, and treatments for conditions for which conventional medicine has few, if any, answers. Therefore, the popular term alternative has been chosen to describe these medical systems and therapies. Another term for these systems and therapies, which is preferred in Europe, is complementary medicine.


This report establishes a baseline of information on alternative medicine, which may be used to direct future research and policy discussions. Specifically, this report will aid OAM in its mandate to establish an information clearinghouse on alternative medicine so that the public, policymakers, and public health experts can make informed decisions about their health care options. The goal of OAM is to speed the discovery, development, and validation of potent treatments that may be added to the complementary wheel of alternatives currently available to patients and practitioners. Ultimately, it may provide the foundation for the development of a whole new system of medicine, one that incorporates the best of conventional and alternative medicines.


Brian M. Berman, M.D.

David B. Larson, M.D., M.P.H.

Cochairs, Editorial Review Board

December, 1994

Executive Summary

Introduction

Medicine in the United States evolved from a mix of Native American, Eastern, and European botanical traditions. In the mid-1800s, the medical system called biomedicine began to dominate. Biomedicine was shaped by the observations that bacteria were responsible for producing disease and characteristic pathological damage and that antitoxins and vaccines could improve a person's ability to ward off the effects of pathogens. With this knowledge, biomedical investigators and clinicians began to conquer devastating infections and to perfect effective surgical procedures.


Thus biomedicine became the "conventional," or mainstream, health care system and began setting the standards for the diagnosis and treatment of every facet of illness. Several decades ago, however, consumer trust in conventional medicine began to falter, and many Americans sought alternative treatments outside conventional medicine. Today, alternative medicine constitutes a significant portion of Americans' health care expenditures.


A number of barriers are preventing promising alternative therapies from being investigated and developed. Structural barriers are caused by problems of classification, definition, culture, and language. Regulatory and economic barriers include legal and cost implications of complying with Federal and State regulations. Belief barriers have been caused by constraining ideologies, misconceptions, and myths.


In late 1992, Congress established the Office of Alternative Medicine (OAM) within the Office of the Director, National Institutes of Health (NIH), to facilitate the fair, scientific evaluation of alternative therapies that could improve many people's health and well-being. OAM, as a de facto intermediary between the alternative medical community and the Federal research and regulatory communities, seeks to reduce barriers that may keep promising alternative therapies from coming to light.


Part I of this report examines six fields of alternative medicine: mind-body interventions, bioelectromagnetics applications in medicine, alternative systems of medical practice, manual healing methods, pharmacological and biological treatments, herbal medicine, and diet and nutrition in the prevention and treatment of chronic disease. Part II deals with a number of cross-cutting issues germane to all six fields, including research infrastructure, research databases, research methodologies, the peer review process, and public information activities. The major recommendations from all chapters are included at the end of this executive summary.

Major Contributors

Editorial Review Board

Other Board Members

NIH Project Officer

Science Editors

Managing Editor

Associate Editor

Contributing Editors

Editorial Assistants

Other Major Contributors_

• Most of the statistics cited in this preface can be found in the publication Healthy People 2000: National Health Promotion and Disease Prevention Objectives, U.S. Department of Health and Human Services (DHHS Pub. No. PHS-91-50212), Washington, DC, 1990. Healthy People 2000 is the latest in a series of reports that have been developed by the U.S. Public Health Service since the early 1970s dealing with issues that affect the health of the Nation.





• This list includes the names of those individuals who made significant writing contributions to the report and/or were consistently involved with the report over the many months required to complete it. Many others at the Chantilly, Virginia, workshop also contributed to the initial discussions and development of broad outlines for various chapters.