Interim Progress
Report
White House
Commission on Complementary
and Alternative
Medicine Policy
September 18, 2001
To leave feedback on this report contact WHCCAMP
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
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.
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
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, http://whccamp.hhs.gov.
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 whccamp@mail.nih.gov.
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.
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
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
14. Ang-Lee MK, Moss J, Yuan C. Herbal medicines and perioperative care. JAMA 2001;286:208-216.
15. Baede-van Dijk, PA. et al. Drug interactions of Hypericum perforatum (St. John's wort) are potentially hazardous. Ned Tijdschr Geneeskd. 2000;144(17):811-2.
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
James S. Gordon, M.D.
Director
The Center for Mind-Body Medicine
2934 Macomb Street, N.W.
Washington, D.C. 20008
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
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: WHCCAMP@mail.nih.gov
WEBSITE: http://whccamp.hhs.gov
Stephen C. Groft, Pharm.D.
Executive Director
E-MAIL: GroftS@mail.nih.gov
Michele M. Chang, C.M.T, M.P.H.
Executive Secretary
E-MAIL: ChangM@mail.nih.gov
Corinne Axelrod, M.P.H., L.Ac.
Senior Program Analyst
E-MAIL: Axelrodc@mail.nih.gov
Joseph M. Kaczmarczyk, D.O., M.P.H.
Senior Medical Advisor
E-MAIL: Kaczmajo@mail.nih.gov
Doris A. Kingsbury
Program Assistant
E-MAIL: kingsbud@mail.nih.gov
Geraldine B. Pollen, M.A.
Senior Program Analyst
E-MAIL: PollenG@mail.nih.gov
CONSULTANT STAFF
Kenneth D. Fisher, Ph.D.
Senior Scientific Advisor
E-MAIL: fisherk@mail.nih.gov
Maureen Miller, R.N., M.P.H.
Senior Policy Advisor
E-MAIL: millemau@mail.nih.gov
James Swyers
Writer/Editor
E-MAIL: jpswyers@starpower.net
Appendix 3
Schedule of Commission Meetings and Material Subjects
Reviewed
·
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
·
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.
·
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
·
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
·
Integrative
Approaches to Wellness - Children, Families and Communities
·
Integrative
Approaches to Wellness - Nutrition
·
Integrative
Approaches to Wellness with Self-Care
·
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
·
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
September
8, 2000
- San Francisco, CA
October
30-31, 2000
- Seattle, WA
January 23,
2001
- New York City, NY
March 16,
2001
- Minneapolis, MN
·
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