Interim Progress Report

White House Commission on Complementary

and Alternative Medicine Policy

September 18, 2001

 

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I.  Introduction

                                                                                                                                                               

The White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) was established by Executive Order 13147 on March 7, 2000, to develop legislative and administrative policy recommendations that will maximize the benefits of complementary and alternative medicine (CAM) practices and products for the general public.

The President and Congress created the Commission in response to the public’s interest in and use of CAM modalities and approaches and in a variety of self-care practices. The Commission is charged with submitting a final report to the President and Congress by March 7, 2002.

This Interim Progress Report provides a brief overview of CAM as well as the Commission and its activities. It also discusses the Commission’s progress to date on developing recommendations around the four major topic areas outlined in the President’s Executive Order.  Individuals and organizations are encouraged to provide written comments on this Interim Progress Report for consideration by the Commission through its website or by letter to the Commission staff.

The Commission’s Charge

The President’s Executive Order (see Appendix 1) charged the Commission to consider four broad topics related to CAM:

·        Coordinated research to increase knowledge about CAM practices and products;

·        The provision to health care professionals of reliable and useful information about CAM that can be made readily accessible and understandable to the general public;

·        Guidance for appropriate access to and delivery of CAM; and

·        The education and training of health care practitioners in CAM.

The Commission’s role is to recommend policies that ensure the public’s health and safety when  accessing CAM practices and products and the practitioners who offer them.  The Commission will also recommend strategies to increase the availability of authoritative information about the safety and efficacy of  CAM practices, techniques, practitioners, and products.

A. Overview of CAM

Definitions of complementary and alternative medicine (CAM) continue to evolve.  CAM generally refers to modalities, practices, techniques, and systems of healing that are used together with (“complementary to”) or instead of (“alternative to”) conventional medicine. Among the modalities that are associated most often with the term CAM are chiropractic, acupuncture, massage therapy, mind-body techniques (e.g., biofeedback, guided imagery, yoga, and meditation), some forms of nutritional therapy, dietary supplements (including herbs), as well as homeopathy, naturopathic medicine, various forms of energy healing, and the indigenous healing systems of the many ethnic groups in the United States.

Over the past decade, several nationwide surveys have documented a substantial and growing usage of CAM practices and products by the American public.1-4 These surveys have found that most CAM users seek out conventional medical treatment first, and then turn to CAM practitioners. Most people appear to use CAM in conjunction with, not as a replacement for, conventional medical therapy, and many seek out care that integrates the best of a variety of approaches.1 The use of CAM modalities, practices, and products by the general population varies in the published literature, ranging from 6.5 percent6 to 42 percent3,8 depending on the population studied and the criteria used to define CAM.  Other studies have documented even higher use of CAM therapies among people with chronic and life-threatening conditions.5,7 For example, a recent study at a major cancer center indicated that 69 percent of patients included CAM approaches as part of their cancer care.7

B.  An Overview Of The Commission: Its Membership and Activities To Date

Commission Membership

The Commission includes twenty members representing a diverse range of expertise in biomedical research, medical and CAM fields.  The Commissioners include the Chair, James S. Gordon, M.D.; George M. Bernier, Jr., M.D.; David E. Bresler, Ph.D.; Thomas M. Chappell; Effie Poy Yew Chow, Ph.D.; George T. DeVries, III; William R. Fair, M.D.; Joseph J. Fins, M.D.; Veronica Gutierrez, D.C.; Wayne B. Jonas, M.D.; Charlotte R. Kerr, R.S.M., R.N., M.P.H., M.Ac.; Linnea S. Larson, LCSW; Tieraona Low Dog, M.D., A.H.G.; Dean Ornish, M.D.; Conchita M. Paz, M.D.; Joseph E. Pizzorno, Jr., N.D.; Buford L. Rolin; Julia Scott; Xiaoming Tian, M.D.; and Donald W. Warren, D.D.S.  (Appendix 2)

Activities To Date


 

The Commission has held seven formal meetings in Washington D.C., all of which have included sessions for open public comment, and four Town Hall meetings, where hundreds of people gave testimony.  In total, the Commission has heard from more than 1,000 speakers and received nearly 2,000 individual comments and recommendations from the public. In the coming months, the Commission plans to review reports from previous commissions and authoritative bodies on the topics identified in its charge and to solicit additional written comments and suggestions from the general public by e-mail, fax, and mail.

Each of the Commission meetings have focused on one or more of the four major topics in the Presidential Executive Order, as follows:

·        July 13-14, 2000: Planning Meeting

·        October 5-6, 2000: Coordination of CAM Research

·        December 4-5, 2000: Access and Delivery of CAM Services and Products 

·        February 22-23, 2001: Education, Training and Credentialing for CAM Practices

·        March 26-27, 2001: Wellness, Self-Care, and Prevention and the Development and Dissemination of CAM Information to the Public

·        May 14-16, 2001: Coverage and Reimbursement of CAM Services and Coordination of CAM Research 

·        July 2-3, 2001: Discussion of the Interim Progress Report and Draft Recommendations

At the four Town Hall meetings held in San Francisco, Seattle, New York City and Minneapolis, testimony was presented on subjects related to all four topics.  Appendix 3 contains a detailed description of the subjects discussed during the Commission and Town Hall meetings.  The transcripts, agenda, and other information pertaining to all Commission Meetings and Town Hall Meetings are available on the Commission’s website,    Additional information, such as Commissioner biographies and a schedule of future meetings, also is readily available at the website which is periodically updated to reflect ongoing activities. Comments, recommendations, and suggestions can be sent though the website, or to .

II.  The Commission’s Progress To Date

The Commission supports the promotion of rigorous science and the appropriate use of the scientific method in research studies.  The Commission recognizes the major ongoing contributions in this area by the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health.  The Commission also supports making the current evidence for CAM practices and products more widely and easily available to the public and health care providers. The Commission recognizes that recommendations in the Final Report about the appropriate use of safe and effective CAM practices and products must be grounded in sound scientific and ethical principles. 

Other principles that will guide the Commission in its deliberations include: an emphasis on health promotion and wellness in addition to disease prevention and the treatment of illness; a recognition that the body has a remarkable capacity for healing that can be facilitated by addressing the underlying causes of illness and suffering; an attention to all aspects of life that can impact health—physical, mental, emotional, environmental, and spiritual; an understanding that each person has unique needs that must be attended to in every therapeutic setting and encounter; and a belief that self-care is integral to our nation’s  healthcare and should be taught to  health professionals and the public.

The Commission also is focused on maximizing the potential benefits of CAM by considering recommendations that promote collaborations between conventional and CAM health care professionals and researchers, and by encouraging the integrated delivery of CAM along with conventional medicine, where appropriate.  Furthermore, the Commission recognizes that consumers have a basic right to choose freely among qualified CAM practitioners and safe products they believe are beneficial to their health, and must be included as partners in any policy or regulatory decisions about CAM access, delivery, and research

The Commission’s recommendations will be formed by the evidence presented and gathered during its deliberations. The diverse perspectives reflected in the testimony heard from advocates, critics and other expert witnesses will be considered in the context of these principles and the potential benefits and risks of CAM use in this country.  This interim report provides an overview of the issues presented to the Commission, including the need for Federal efforts to ensure access by the public to safe and efficacious CAM services and products, and for reliable and timely information.

A number of speakers noted that many CAM systems of practice place an emphasis on promoting wellness in addition to treating illness and dysfunction.  There was considerable public support for the Federal government to help shape health promotion initiatives and disseminate information to the public on CAM as well as conventional approaches to wellness and disease prevention.

A.  Coordination Of Complementary And Alternative Medicine Research 

Americans are seeking out and using CAM practices and products.  In many cases, people are using these practices and products without the scientifically-based information necessary to make informed choices about their safety and efficacy. Individuals who testified, from both the CAM and conventional medical communities, agreed that the public’s health and safety calls for more rigorous scientific research and more readily available information on the results of CAM research that already exist.  Underlying all research is the paramount goal of producing dependable and relevant information for practitioners and the public.

Testimony to the Commission described a growing interest in and support for CAM research, not only on the part of the CAM community and the public, but also at the Federal level, in academic health centers, in community hospitals, and in mainstream private practices.  This interest has further stimulated CAM professional schools and manufacturers of CAM products to enhance their own research capacity.  The NIH research Institutes and Centers, including the NCCAM, plans to fund over $220 million for CAM research and research training in Fiscal Year 2002.  The importance of public input into the research agenda was discussed often during testimony.

Speakers identified several types of evidence-based medical research they believe are needed, such as studies on the basic mechanisms of action; clinical safety and efficacy; treatment outcomes; and health services, including cost-effectiveness and health care delivery.  Speakers and Commissioners agreed that to be methodologically sound, CAM-related studies must have a clear question (hypothesis); a sound study design; a qualified research team; objective, verifiable data; and balanced conclusions that meet acceptable standards of evidence.  There was general agreement that the research should meet high standards of design and execution consistent with the type of information being sought; that strategies be applied that appropriately incorporate step-wise approaches to research sequence and design, as is done in many areas of conventional medical research; and that clinical research comply with human subject protections and appropriate institutional review board guidelines.

Many of those who testified agreed that CAM research might be best served by collaborations between conventional and CAM researchers and clinicians.  One goal of these collaborations is to produce research results that meet the rigorous publication requirements of published and on-line peer-reviewed journals that already set standards for the conventional medical community. Testimony also emphasized the need for continued support for training conventional and CAM researchers to study CAM therapies; increased support for developing research infrastructures at accredited CAM and conventional institutions; and for developing funding initiatives to study promising nonpatentable products.

Support and coordination of CAM activities by agencies of the Federal government were seen as essential to ensure the types and quality of studies needed as key elements in achieving research progress in these areas.  Numerous speakers identified strong and continued support for agencies involved in CAM research and related activities and support for all other Federal agencies with research or related responsibilities.  (See Appendix 4)  In addition, there was considerable public support for encouraging the private sector--foundations, product manufacturers, and pharmaceutical companies--to support CAM research and collaborate with the Federal sector in strengthening research efforts.

Regulatory Activities

Effective regulations serve and protect the public by ensuring compliance with standards that are shaped by good research, and removing harmful products from the marketplace.  Public testimony supported the importance of the Federal government’s role in ensuring that CAM products are safe.  Testimony also expressed concern that the content and purity of some CAM products, such as dietary supplements, are inconsistent and could potentially have negative health consequences.  Testimony indicated that the Food and Drug Administration (FDA) has authority, through the Dietary Supplement Health and Education Act (DSHEA), to ensure product safety but FDA’s resources have not been commensurate with these responsibilities.  In the testimony, there was strong support to fully implement DSHEA, provide adequate funding for its full implementation, and ensure that the FDA has adequate professional staff with expertise in dietary supplements, particularly botanical products.

A number of speakers, including many from the dietary supplement industry, asked that the FDA establish regulations on Good Manufacturing Practices (GMPs) for quality control and  guidelines on processing and production as approaches to ensuring the safety and integrity of all products during manufacture.  They also called upon Federal agencies and the private sector to coordinate efforts to establish and implement guidelines standardizing the composition and purity of products, and to address possible contaminants and adulterants.  Researchers asked for standards that will result in a readily available supply of products with consistent composition to assure reliable research results.  There was also support for the establishment of a dedicated CAM-related office and/or CAM-related core review teams to facilitate the regulatory review of CAM products.

Although the number of adverse events reported from the use of dietary supplements is relatively  small, any adverse event can become a public health issue. Several speakers asked for a strengthening and expansion of the FDA’s adverse event reporting (AER) system and for this information to be made widely available.  This is consistent with a recent report from the Office of the Inspector General of the Department of Heath and Human Services that describes the current limitations of the AER system for all products and provides recommendations to improve it.9

Testimony focused on the need for manufacturers to make information on the benefits and risks of herbs and dietary supplements readily available to consumers and health care professionals through methods such as improved labeling, package inserts, and information at points-of-sale.  This information should include any limitations; known interactions with drugs, foods, and other health products; and possible risks to vulnerable populations, including children, the elderly, pregnant and nursing women, and those with certain health conditions or compromised immune systems. 10

B.   Providing Reliable, Useful Information on CAM to Healthcare Professionals and the Public

The Commission heard testimony that the quality, accuracy, accessibility, and timeliness of information on CAM practices and products vary greatly, and there is a significant need for accurate, authoritative, and up-to-date information about CAM.  People want to know which CAM approaches might work for them, where they can find professionals qualified to provide these services, and how CAM therapies might interact with their conventional treatments. Clinicians, likewise, need information on the safety and efficacy of various CAM approaches so that they can converse with their patients about CAM and make appropriate and authoritative recommendations and referrals.

Internet, Radio, Television, and Print Media

The Internet has emerged as a major source of health care information, including information related to CAM, for both consumers and health care providers. The Federal Trade Commission (FTC) predicts that 30 million Americans will seek health information online in 2001 and that this number is increasing dramatically.11 There are numerous CAM-specific websites as well as a variety of general health information sites that include some CAM information. According to public testimony, some of these sites provide accurate and current information, while many others contain inaccurate, misleading, self-serving, or outdated information.

The Commission heard that for people without access to the Internet or the skills to use the Internet, the National Library of Medicine and the public libraries, through the American Library Association, are training librarians to help people gain access to health information on the Internet.  It was suggested that these efforts also could be used to help people gain access to information on CAM practices and products. 

Similarly, the Commission heard testimony that television, radio, and print media coverage of CAM benefits and safety issues is often uneven, incomplete, or biased.  Media representatives, health professionals, and the general public said that several Federal agencies provide important and useful resources for information on the benefits and safety of CAM.  However, they said they are still hampered in their efforts to obtain objective, comprehensive information about CAM by the lack of a central, authoritative resource within the Federal government that can quickly and reliably answer questions on a variety of CAM issues. 

Many people from the conventional and CAM professional communities, the public, and the media asked the Federal government to assume a greater leadership role in providing and coordinating authoritative information about CAM practices and products in an easily accessible form that ensures consistent, quality information.

Public testimony described indigenous systems of healing and the use of culturally based CAM therapies among people of different racial and ethnic groups.  Community leaders called for the development and promotion of information on the appropriate use of CAM therapies that would be targeted to diverse population groups in the United States.

Public testimony suggested that the Federal government establish a public education campaign that teaches consumers how to evaluate and assess information on treatments that have not been evaluated by the FDA.  It also was suggested that a public-private partnership be created to establish a voluntary code of standards for information available on the Internet and through other media, including standards for ethics and disclosure of conflicts of interest.

 

Advertising, Marketing, and Labeling Regulatory Activities

Advertising, marketing, and labeling are important mechanisms for disseminating information to the public about products.  The Commission heard testimony that there is a significant amount of false and misleading advertising, marketing, and labeling of CAM products and practices, especially herbal and dietary supplements. Of particular concern is the marketing of products or services that may be unnecessary, harmful, or otherwise detrimental to the general public, including low-income populations, the elderly, and non-English speaking people.  False and misleading advertising may lead people to seek treatments that are not only costly, but also may delay or interfere with more appropriate or effective treatments. 

The Commission heard about the role of the FTC in identifying false and deceptive CAM-related health claims, and their efforts to minimize the occurrence of these claims.  There was public support for sufficient resources for Federal agencies such as the FTC and the Consumer Product Safety Commission to improve oversight of CAM products and services.  Testimony also underscored the need for increased consumer education in identifying deceptive and unsubstantiated claims in all forms of marketing and advertising, and the importance of involving trusted community leaders in developing successful strategies to prevent consumer exploitation.

 

C.  Access to and Delivery of Complementary and Alternative Medicine

 

Access to and delivery of health care services affect health care utilization and health outcomes.  Many factors influence access to and delivery and utilization of health care services. These factors may include quality of care; distribution and availability of local providers; licensing, certification, and credentialing of providers; coverage and reimbursement; characteristics of the health care delivery system; and consumer outreach, education, and satisfaction. The Commission heard testimony that, as with conventional care, these factors often are more problematic for rural, uninsured, underinsured, and diverse populations.

Consumers, health care professionals, and representatives of professional organizations and educational institutions told the Commission that Americans want to be able to choose from conventional and CAM practices and products, and they want assurances that practitioners are qualified and products are safe.  According to testimony, many Americans have neither this choice nor these assurances.

Testimony described how States regulate health care practitioners by helping to assure quality and accountability of professions and providing a process for professional conduct review and disciplinary action.  Information provided to the Commission illustrates State-by-State variability in regulatory approaches to licensure and scope of practice.  This information shows that chiropractors are licensed in all States, while acupuncturists, massage therapists, and naturopathic physicians are licensed in 40, 30, and 11 states, respectively.  These variations impact access to and delivery of CAM by limiting practitioners’ ability to practice lawfully and obtain malpractice insurance. 

While some CAM professions endorse licensure and certification to participate more fully in the health care delivery system, several witnesses testified that licensure or certification is not feasible for some categories of CAM practitioners such as Native American and other traditional healers.  Some CAM practitioners consider their disciplines to be educational (Alexander Technique) or spiritual (Reiki) and have expressed concerns about licensing as health professionals.  The Commission also heard from several conventional practitioners who incorporate CAM modalities in their practices and are concerned that their integrative approach does not lend itself to the licensure process.  Some, but not all, of the conventional practitioners who testified recommended that scope of practice laws be broadened to allow latitude for CAM modalities to be used. 

The Commission heard about several models of delivery of CAM services.  These included solo CAM practitioners, freestanding CAM facilities offering multiple CAM approaches; collaborative models that support referrals, consultation, and co-management; and a variety of integrative models in which CAM practitioners work with conventional practitioners. There has been little evaluation of the effect on access, clinical outcomes, or cost-effectiveness of these models.

While many of those testifying supported integrative models of delivery, a perspective of some CAM practitioners was that the integrity, philosophy, and standards of CAM disciplines may be compromised, and the effectiveness of CAM practices may be diminished or lost, as various integrative approaches are explored.  Other CAM practitioners suggested that if integration occurs, it should include entire systems of care and healing rather than only selective incorporation of CAM modalities that fit into the biomedical model.  The importance of educating conventional practitioners in the philosophical and historical roots of CAM disciplines was cited as an important step in preserving the integrity of these other systems of care and healing.

Testimony indicated variation in use of CAM among people of different racial, ethnic, and cultural backgrounds, as well as geographic, economic, and condition-specific variations. However, testimony provided little information regarding factors that determine consumer choice of CAM practices and products.  Obtaining this information is important in the appropriate design, development, and implementation of policies and programs. 

Coverage And Reimbursement Of CAM Practices And Products 

The Commission heard from a spectrum of experts on health care financing, the insurance and managed care industries, and other issues regarding coverage and reimbursement of CAM practices and products.  Employers and other health plan sponsors are the major purchasers of health coverage and, in conjunction with insurance companies and managed care organizations, they determine which health benefits are covered and how the services are reimbursed for most Americans. 

Testimony indicated increasing interest in and coverage of CAM services by employer-sponsored health plans in direct response to employee requests.  They also are increasingly adding CAM benefits to attract and retain employees, improve health, and comply with State mandates.  Various employer-sponsored health plans were described, including:  limited coverage for certain CAM services (e.g. chiropractic care) as part of a basic benefit package; information-only programs (e.g. Internet-based programs related to CAM modalities); on-site services (e.g. yoga classes); a CAM benefit account (e.g. a $500 annual maximum benefit, with employee co-payments), discount programs (employees may receive CAM services and pay a discounted fee by using a pre-screened panel of CAM providers), or benefit riders (employees may opt to participate in a CAM managed care plan that offers certain services through a credentialed network of CAM providers and with utilization controls).

Federal and State governments are also major purchasers of health care.  The Federal government, often through Congressional legislation, makes decisions regarding the health benefits for Medicare, Medicaid, the military, veterans, Federal employees, and others, including funding for the State Children’s Health Insurance Program.  Some Federally-sponsored sites, such as military and veterans’ treatment facilities, are beginning to make some CAM benefits available.  States establish health plans for their employees and share responsibility with the Federal government for the Medicaid program and the State Children’s Health Insurance Program.  States usually enhance the Federally mandated benefits available under Medicaid and extend Medicaid coverage to the medically indigent. 

Despite such programs, an overwhelming majority of Americans do not have coverage or reimbursement for CAM services or products. They must pay out-of-pocket for CAM treatment of diseases and for prevention and wellness services. Thus, access to CAM products and practices appears to be limited largely by the ability to pay.  Other witnesses noted that limited access to CAM practices and products is part of the larger problem of limited access to all health care.

Representatives of the insurance and managed care industries told the Commission that they are interested in adding covered benefits provided that the services and products are safe, of consistently high quality, are no longer investigational, and that criteria exist for determining medical necessity.  They also want standards of practice to guide utilization, assure quality care, and manage financial risk (in view of the potential for malpractice/medical liability suits).  Another requirement they specified is that practitioners are adequately educated, trained, and qualified by licensure and/or certification. 

Those health care purchasers who are interested in offering CAM services often must base their decisions on incomplete information on safety, efficacy, and cost-effectiveness.  They also expressed a strong interest in research on determining whether CAM services and products would be replacements for or additions to conventional services and products.  Purchasers testifying before the Commission identified a need for the development of appropriate coding for CAM services, improvement of the collection of claims data, and the development of databases for managing information and conducting research on the cost-effectiveness and utilization of CAM.  It was suggested that public agencies and private organizations co-sponsor conferences on the development of data on CAM services and products to address issues of coding and building claims databases, and to identify what decision-makers need regarding utilization and cost information.

Public testimony recommended that health services research and demonstration projects be funded by public, private and joint public-private sources to provide information on the efficacy, cost-effectiveness, and cost-benefits of CAM practices and products.  It was also requested that the Federal government establish and adequately fund efforts to make CAM research results more available and accessible to the public and to industry, particularly employers, insurers, and policymakers at the Federal and State levels.

D. The Education and Training of Health Care Practitioners in CAM

Testimony underscored the importance of increasing the knowledge and understanding of CAM among conventional health care practitioners to enhance and protect the public’s health. It was suggested that a basic or core CAM curriculum for conventional health care professionals be developed at the professional schools, in postgraduate training programs, and at continuing education programs.  It also was suggested that these curricula in CAM fundamentals and principles should be developed in conjunction with CAM experts.  The curricula should establish, to the extent possible, an evidence-based foundation for conventional health professionals to discuss CAM use with their patients, to make referrals to appropriately trained CAM professionals, and to develop an understanding of the interactions, either therapeutic or harmful, between conventional and CAM treatments to improve and safeguard their patients’ health.

Consumer testimony revealed that many people are reluctant to disclose their CAM use to their conventional health care providers whom they believe are not knowledgeable about CAM or interested in CAM approaches to healing. This represents a potential health hazard because conventional practitioners often do not know that their patients may be taking dietary supplements or using CAM practices and products which may interact with medical treatments, 9,12,13or perioperative care associated with anesthesia or surgical procedures.13,14,15 

 Another issue that emerged during testimony was the need to educate CAM practitioners in the basics of conventional health care so that they can recognize the limits of their clinical expertise and potential complications of their interventions, and make appropriate referrals to conventional health care providers. It was suggested that a basic curriculum for CAM students and practitioners should include information about evidence-based conventional medicine, conventional health care, and other CAM modalities and systems of heath care.  The Commission learned about innovative models of cooperative and collaborative CAM training programs, which expose conventional medical and CAM students to each other’s philosophies and practices.  Continuing education programs exist for audiences composed of both conventional and CAM practitioners.

A number of CAM representatives reported that there is a need for access to funding and other resources for faculty, curricula, and program development as well as for student access to loan and scholarship opportunities. Testimony also suggested that training of CAM professionals should include high quality postgraduate and continuing education programs that resemble those currently available to conventional health care providers.

E.  Coordinating And Centralizing Federal CAM  Efforts 

The Commission heard testimony recommending a centralized process at the Federal level to coordinate CAM activities to ensure optimal access to safe and effective CAM products, services and modalities. The Commission will continue to consider a range of administrative options to promote this level of coordination, including the creation of a centralized Federal office.  The Office on Women’s Health, or the Office on Minority Health, both established within the Office of the Secretary for Health and Human Services, may provide useful models from which the Commission can develop an operational proposal.  These Offices primarily serve to coordinate, support, and enhance ongoing and new Federal efforts relevant to their missions at all levels of the Federal sector.  Thus, a centralized coordinating entity for CAM would neither preempt nor supplant those Federal efforts already in place, particularly the research activities or agenda of the NIH’s National Center for Complementary and Alternative Medicine.  Nor would it supplant the responsibilities of regulatory agencies, such as the Food and Drug Administration and the Federal Trade Commission. 

F. CAM In Wellness, Self-Care, Health Promotion And Disease Prevention

The role of CAM in wellness, self-care, health promotion and disease prevention was a frequently emphasized topic throughout the testimony provided to the Commission, including areas where CAM may assist in achieving the Nation’s health promotion and disease prevention goals.  Since the publication of  Healthy People: The Surgeon General’s Report on Health Promotion and Disease in 1979, goals and objectives for the Nation’s health have been defined and monitored.  The most recent report, Healthy People 2010, includes the involvement of all of the agencies within the Public Health Service, as well as State and local health departments and a wide range of private sector health organizations.  Witnesses testified that the integration of CAM in health promotion and disease prevention could have profound positive consequences for the wellness and quality of life of individuals, and may impact on the health care delivery system of the United States.  

Many CAM disciplines are derived from cultural traditions and practices that are rooted in connections between the body, mind, and spirit and between individual health and the community’s well being.  Public testimony recommended that CAM principles and practices of health promotion be taught at all levels of the educational system, and that methods be explored  to integrate CAM principles (e.g. connection of body, mind and spirit) and practices (e.g. stress reduction techniques and nutrition) into a national health and wellness initiative.

In the testimony presented to the Commission, the current health care system was described as primarily disease-focused, with most of research, education, training, reimbursement, and information development and dissemination directed toward identifying and treating diseases and conditions.  Some who testified believe that the incorporation of CAM principles and practices into the current health care system would improve the emphasis on wellness, self-care, health promotion and disease prevention.  Many feel that one of the most important and enduring contributions of CAM will be its emphasis on maintaining wellness and the important role of self-care.

Witnesses described programs in schools, the workplace, geriatric centers, and other institutions that are integrating CAM approaches to wellness, self-care, and prevention into their activities, and recommended that these programs be studied and expanded.  It was also emphasized that conventional health professionals need to have some training in the role of CAM in wellness, self-care, and prevention, and that a multi-disciplinary team approach, with CAM and conventional providers working together, may be a very effective way to promote health and enhance self-care and wellness.

III.  Conclusion

The Commission continues to deliberate on all of the issues discussed in the Interim Progress Report and others to fully comply with the Executive Order.  The Commission continues to study working models from many sources, including those from other countries. The Final Report will provide detailed recommendations regarding the four topics identified in the Executive Order: coordinating research on CAM; providing access to and delivery of CAM practices and products; developing and providing reliable information on CAM; and educating all health care practitioners in CAM.  The recommendations will reflect principles that guide good health care; promote sound scientific inquiry related to CAM; maximize access and delivery of safe and efficacious health care; and promote health and prevent illness by encouraging the well-being of the whole person.  As the Commission develops final recommendations and proposals for legislative and administrative actions, it will continue to solicit and consider the advice of the public.


 

References:

1.      Astin JA. Why patients use alternative medicine: results of a national study JAMA 1998; 279: 1548—53.

2.      Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR. Delbianco TL. Unconventional medicine in the United States. New Engl J Med 1993:328:246—52.

3.      Eisenberg DM, Davis RB, Ettner SL, et al. Trends in CAM use in the United States 1990—1997, Results of a follow-up national survey. JAMA 1998;280:1569—75.

4.      Paramore, LC. The use of alternative therapies: Estimates from the 1994 Robert Wood Johnson Foundation National Access to Care Survey. J Pain Sympt Manage 1997;13(2):83-89.

5.      Rao JK, Mihaliak K, Kroenke K, Bradley J, Tierney WM, Weinberger M. Use of complementary therapies for arthritis among patients of rheumatologists. Ann Intern Med 1999;131:409—16.

6.      Druss BG and Rosenheck RA. Association between use of unconventional therapies and conventional medical services, JAMA 1999; 282: 651-656

7.      Richardson MA, Sanders T, Palmer JL, et al. Complementary/alternative medicine use in a comprehensive cancer center and implications for oncology. J Clin Oncol 2000;18(13):2501-2504.

8.      Fairfield KM, Eisenberg DM, Davis RB, Libman H, Phillips RS. Patterns of use, expenditures, and perceived efficacy of complementary and alternative therapies in HIV-infected patients. Arch Intern Med 1998;158:2257-64.

9.      Office of Inspector General, Department of Health and Human Services, Adverse Event Reporting for Dietary Supplements: An Inadequate Safety Valve, OEI-01-00-00180, April 2001.

10.  Blendon R, et al. American’s views on the use and regulation of dietary supplements. Arch Intern Med 2001; 161:805-810.

11.  Federal Trade Commission, Protecting Consumers Online: A FTC Report on the First Five Years of Its Internet Law Enforcement Program, Dec 1999

12.  Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J. Indinavir concentrations and St John's wort.  Lancet. 2000;355(9203):547-8.

13.  Fugh-Berman A. Herb-drug interactions. Lancet 2000; 355:134-138

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Appendix 1

THE WHITE HOUSE

 EXECUTIVE ORDER 13147

WHITE HOUSE COMMISSION ON COMPLEMENTARY

AND ALTERNATIVE MEDICINE POLICY

     By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Federal Advisory Committee Act, as amended (5 U.S.C. App.), and in order to establish the White House Commission on Complementary and Alternative Medicine Policy, it is hereby ordered as follows:

     Section 1.  Establishment.  There is established in the Department of Health and Human Services (Department) the White House Commission on Complementary and Alternative Medicine Policy (Commission).  The Commission shall be composed of not more than 15 members appointed by the President from knowledgeable representatives in health care practice

and complementary and alternative medicine.  The President shall designate a Chair from among the members of the Commission.  The Secretary of Health and Human Services (Secretary) shall appoint an Executive Director for the Commission.

     Sec. 2.  Functions.  The Commission shall provide a report, through the Secretary, to the President on legislative and administrative recommendations for assuring that public policy maximizes the benefits to Americans of complementary and alternative medicine.  The

recommendations shall address the following:

(a)  the education and training of health care practitioners in complementary and alternative medicine;

(b)  coordinated research to increase knowledge about complementary and alternative medicine practices and products;

(c)  the provision to health care professionals of reliable and useful information about complementary and alternative medicine that can be made readily accessible and understandable to the general public; and

(d)     guidance for appropriate access to and delivery of complementary and alternative medicine.

            Sec. 3.  Administration.  (a)  To the extent permitted by law, the heads of executive departments and agencies shall provide the Commission, upon request, with such information and assistance as it may require for the purpose of carrying out its functions.

(b)  Each member of the Commission shall receive compensation at a rate equal to the daily equivalent of the annual rate specified for Level 1V of the Executive Schedule (5 U.S.C. 5315) for each day during which the member is engaged in the performance of the duties of the Commission.  While away from their homes or regular places of business in the performance of the duties of the Commission, members shall be allowed travel expenses, including per diem in lieu of subsistence, as authorized by law for persons serving intermittently in Government service (5 U.S.C.  5701-5707).

(c)  The Department shall provide the Commission with funding and with administrative services, facilities, staff, and other support services necessary for the performance of the Commission's functions.

(d)  In accordance with guidelines issued by the Administrator of General Services, the Secretary shall perform the functions of the President under the Federal Advisory Committee Act, as amended (5 U.S.C. App.), with respect to the Commission, except that of reporting to the Congress.

(e)  The Commission shall terminate 2 years from the date of this order unless extended by the President prior to such date.

WILLIAM J. CLINTON

THE WHITE HOUSE,

March 7, 2000.

           

                                                                


 

 

 THE WHITE HOUSE

                       

September 15, 2000

EXECUTIVE ORDER

AMENDMENT TO EXECUTIVE ORDER 13147, INCREASING THE MEMBERSHIP OF THE WHITE HOUSE COMMISSION ON COMPLEMENTARY AND ALTERNATIVE MEDICINE POLICY

     By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Federal Advisory Committee Act, as amended (5 U.S.C. App.), and in order to increase the membership of the White House Commission on Complementary and Alternative Medicine Policy from not more than 15 members to up to 20 members, it is hereby ordered that the second sentence of section 1 of Executive Order 13147 of May 7, 2000, is amended by deleting "not more than 15" and inserting "up to 20" in lieu thereof.

                                                           

WILLIAM J. CLINTON

THE WHITE HOUSE,

September 15, 2000.

Appendix 2          

White House Commission on Complementary and Alternative

Medicine Policy

COMMISSION ROSTER


 

CHAIRPERSON

James S. Gordon, M.D.          

Director

The Center for Mind-Body Medicine

2934 Macomb Street, N.W.   

Washington, D.C.  20008                  

COMMISSIONERS

George M. Bernier, Jr., M.D.             

Vice President for Education, Emeritus

University of Texas

2424 Sydnos Lane

Galveston, Texas   77554

David Bresler, Ph.D, LAc, OME,

Dipl.Ac. (NCCAOM)

Founder and Executive Director

The Bresler Center, Inc.

30765 Pacific Coast Hwy #355

Malibu, California  90265

                                               

Thomas Chappell

Co-Founder and President

Tom’s of Maine, Inc.

P.O. Box 710

Kennebunk, Maine  04043

Effie Poy Yew Chow, Ph.D., R.N.,

DiplAc (NCCA), Qigong Grandmaster

President

East West Academy of Healing Arts

530 Bush Street, Suite 104-202

San Francisco, California  94108

 George T. DeVries, III          

CEO/President

American Specialty Health Plans

777 Front Street

San Diego, California   92101

William R. Fair, M.D.

Attending Surgeon, Emeritus

Memorial Sloan-Kettering Cancer Center

435 L’Ambiance Drive, #806

Longboat Key, Florida, 34228

Joseph J. Fins, M.D., F.A.C.P.

Associate Professor of Medicine

Weill Medical College of Cornell University

Director of Medical Ethics

New York Presbyterian Hospital-Cornell Campus

525 East 68th Street, F-173

New York, New York  10021

Veronica Gutierrez, D.C.

Gutierrez Family Chiropractic

3704 172nd Street, NE-Suite N

Arlington, Washington  98223

Wayne B. Jonas, M.D.

The Samueli Institute

Director

5411 West Cedar Lane

Suite 205A

Bethesda, Maryland   20814

Linnea Signe Larson, LCSW, LMFT

455 Washington Boulevard

Oak Park, Illinois 60302-4030

Tieraona Low Dog, M.D., A.H.G.

President, Chief Medical Officer

Integrative Medicine Education

   Associates, LLC

353 Loma Larga NW

Corrales, New Mexico  87048

Charlotte R. Kerr, R.S.M.

Traditional Acupuncture Institute, Inc.

American City Building

10227 Wincopin Circle, Suite 100

Columbia, Maryland  21044

Dean Ornish, M.D.

President and Director

Preventive Medicine Research Institute

Clinical Professor of Medicine

University of California, San Francisco

900 Bridgeway, Suite 2

Sausalito, California   94965

Conchita M. Paz, M.D.

1510 Altura Avenue

Las Cruces, New Mexico  88001

Joseph E. Pizzorno, Jr., N.D.

President Emeritus, Bastyr University

4220 NE 135th St

Seattle, WA  98125

Buford L. Rolin

Poarch Band of Creek Indians

308 Forest Avenue

P.O. Box 19

Atmore, Alabama   36504

Julia R. Scott

1306 Palmyra Lane

Bowie, Maryland 20716

Xiaoming Tian, M.D., L.Ac

Director, Wildwood Acupuncture Center

Director, Academy of Acupuncture & Chinese Medicine

Wildwood Medical Center

10401 Old Georgetown Road

Suites 102/104

Bethesda, Maryland  20814

Donald W. Warren, D.D.S.

Diplomate of the American

Board of Head, Neck & Facial Pain

390 Factory Road

Clinton, Arkansas 72031

EXECUTIVE STAFF

White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP)

6707 Democracy Boulevard

Room 880, MSC-5467                       

Bethesda, Maryland  20892-5467

TEL: 301-435-7592 or 1-866-373-1124

FAX: 301-480-1691

E-MAIL:

WEBSITE:

Stephen C. Groft, Pharm.D.

Executive Director

E-MAIL:

Michele M. Chang, C.M.T, M.P.H.

Executive Secretary

E-MAIL:

Corinne Axelrod, M.P.H., L.Ac.

Senior Program Analyst

E-MAIL:

Joseph M. Kaczmarczyk, D.O., M.P.H.

Senior Medical Advisor

E-MAIL:

Doris A. Kingsbury

Program Assistant

E-MAIL:

                       

Geraldine B. Pollen, M.A.

Senior Program Analyst

E-MAIL:

CONSULTANT STAFF

Kenneth D. Fisher, Ph.D.

Senior Scientific Advisor

E-MAIL:

Maureen Miller, R.N., M.P.H.           

Senior Policy Advisor

E-MAIL: 

James Swyers

Writer/Editor

E-MAIL: 



 

 

Appendix 3      Schedule of Commission Meetings and Material Subjects Reviewed

Commission Meetings

July 13-14, 2000 - Planning Meeting

·        Discussion of Vision, Issues and Concerns of the Commission Members on Issues Presented in Executive Order

·        Development of Meeting Schedule

·        Discussion of Website Development and Content

October 5-6, 2000 - Coordination of CAM Research & Achievements, Opportunities, Obstacles and Solutions

·        Public Input and Research Priorities

·        Federal Support for CAM Research

·        Academic Centers and Support for CAM Research

·        Research Support and Collaborations at the NIH

·        Facilitating CAM Research and Regulatory Challenges

·        Research in the Regulatory Framework

·        Outcomes Research - Interface between CAM Research and Regulatory Agencies

·        Outcomes Research - CAM Research and Experimental Study Design

·        Guiding Principles of CAM Perspectives and Practices

·        Support for CAM Research - The Not-for-Profit Sector

·        Support for CAM Research - The Private Sector

·        Support for CAM Research - Federal Agency Support

December 4-5, 2000 - Access and Delivery of CAM Services

·        Utilization of CAM Services and Products

·        Cost Effectiveness of Selected CAM Services

·        Clinical Effectiveness of Selected CAM Services

·        Use of CAM for Selected Health Conditions

·        Issues in Integrating CAM in Service Delivery

·        Meeting Public Needs: Systems of CAM Delivery at Community Health Clinics, in Private Practice and Hospital-based Centers, in Hospice Care, at Academic Research Centers and in Managed Care Organizations.

February 22–23, 2001 - Training, Education, Credentialing and Licensing of CAM Practices

·        CAM Education and Training: Establishing Educational Programs

·        Continuing CAM Education and Training - Building Knowledge and Skills

·        CAM Credentialing and Licensure - Assuring Quality and Accountability in CAM Practices

March 26-27, 2001 - Development and Dissemination of CAM Information

·        CAM in the Media - Newspapers, Magazines, Television and Radio

·        CAM in the Media - The Internet

·        Evaluation of available CAM Information

·        Marketing and Advertising of CAM Services and Products

           

March 27, 2001 - CAM in Wellness and Self Care

·        Integrative Approaches to Wellness - Children, Families and Communities

·        Integrative Approaches to Wellness - Nutrition

·        Integrative Approaches to Wellness with Self-Care

May 14-15, 2001 - Coordination of CAM Research

·        Not-for-Profit Support for CAM Research

·        Investigating the Scientific Bases of CAM Practices

·        Approaches to Evaluating CAM Research Literature

·        Challenges of CAM Research and Research Training

·        Peer Reviews of CAM Research Results in the Published Literature

May 15-16, 2001 - Coverage and Reimbursement of CAM Services

·        Health Care Financing in the United States

·        Federal Purchasers

·        State Perspectives

·        Employer Coverage

·        The Underinsured, Uninsured and Minorities

·        Health Plans and CAM Benefits

·        Healthcare Insurance - Providers Perspectives

·        Evolving Health Care Systems

July 2-3, 2001 – Discussion of Interim Progress Report

Town Hall Meetings

September 8, 2000      - San Francisco, CA

October 30-31, 2000   - Seattle, WA

January 23, 2001         - New York City, NY

March 16, 2001           - Minneapolis, MN

Topics Discussed

·        Access, Financing and Reimbursement of CAM Practices and Products

·        Integration of CAM into Health Care Delivery Systems

·        Dietary Supplements and Herbal Products

·        Education of CAM Providers

·        Education of Health Professionals

·        Culturally - Based Healing Traditions

·        Regulation of CAM Practices and Products

·        Washington State and Minnesota State Legislation of CAM Practices and Products

·        Development and Dissemination of CAM-Related Information

·        Accountability of CAM Providers

           

Future Meeting Dates of the Commission

·        October 4-6, 2001 Bethesda, MD

·        December 6-7, 2001 Washington, DC

 

Appendix 4

FEDERAL AGENCIES WITH HEALTH RESEARCH AND/OR RELATED ACTIVITIES

Department of Health and Human Services

National Institutes of Health (NIH)

Agency for Healthcare Research and Quality (AHRQ)

Food and Drug Administration (FDA)

Health Resources and Services Administration (HRSA)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Centers for Disease Control and Prevention (CDC)

Centers for Medicare and Medicaid Services (CMS)

   (formerly the Health Care Financing Administration)

Indian Health Service (IHS)

 

department of agriculture

Department of Defense

department of education

department of energy

department of labor

Department of Veterans Affairs

Independent Agencies

 

Consumer Product Safety Commission

Environmental Protection Agency

Federal Trade Commission

National Aeronautics and Space Administration

National Science Foundation