How NCCAM's "Real World" Congressional Mandate is Optimal for NCCAM's 2010-2015 Strategic Plan
Written by John Weeks
Friday, 06 November 2009
How NCCAM's "Real World" Congressional Mandate is Optimal for NCCAM's 2010-2015 Strategic Plan
Summary: This
article aims to help you respond, as a stakeholder, to the next
NCCAM strategic plan. Responses are due November 30. I first analyze the 1998 Congressional mandate relative to this
most important issue that will face the integrative practice community
in the coming 5 years; namely, the prioritization of $600-million the NIH NCCAM will spend. The mandate will surprise you: prioritized were outcomes research, exploration of "prevention modalities,
disciplines and systems" and evaluation of "integration ... into delivery systems" rather than the basic research and RCTs that
dominated NCCAM under its first director. Now, as NCCAM seeks your input, even as it is being reasonably challenged
for having created limited value to date, might NCCAM be served to
embrace what Congress originally mandated? I offer 14 trends in the
healthcare and policy worlds and inside the integrative healthcare
community that make the direction Congress' mandated 11 years ago even
more auspicious at this time. This article is background for submitting
your own stakeholder inputs on the NCCAM strategic plan. Get your
comments in by November 19!
Note: NCCAM's mandate from Congress is analyzed below,
then, following some trend, information printed in full at the bottom.
It is also available as pages 388-390 of this 920 page Federal document.
Congress mandates an exploration of real world outcomes, disciplines, systems and integration
What is startling is how significantly Congress focused NCCAM on real
world outcomes given that NCCAM, under founding director Stephen
Straus, MD devoted just 0.4%-1.13% of its funding to effectiveness and
cost-effectiveness research. (See Making Amends: Studies of Effectiveness and Cost-Effectiveness Represent <1% of NCCAM Budget.) The question before us now is: Might NCCAM's work be more valuable if the next strategic plan embraced this Congressional charge?
This article begins with a section by section look at the brief 2 pages of NCCAM's Congressional mandate. (The entire document is appended at the bottom of this article, unmixed with my
opinions.) I
then list 14 healthcare, research and policy trends and changes that argue
that the time is even more auspicious in 2010 for moving in the
direction Congress, in its wisdom, urged in 1998. After you reflect on these - or before you do! - please weigh in. You are an NCCAM stakeholder. Be heard. Click here at the NCCAM strategic planning site.
________________________
Part I: Analysis of NCCAM's 1998 Congressional Mandate
Note: NCCAM's first of 3 white papers on its current strategic plan focuses on Mandate and Mission.
The paper directly cites subsections (a), (c) and (g) of the
Congressional mandate, leaving sections (b), (d), (e), (f) and (h). I
bolded the portions not included in the 2009 NCCAM white paper.
NCCAM -- Included some but not other sections of the mandate
NCCAM's Introductory Comment from the 2009 NCCAM Strategic Planning White Paper #1: "The legislative mandate of NCCAM has
remained constant since the Center was created in 1998. Specifically, Congress
felt that the public health and policy implications of the widespread use of
complementary and alternative medicine (CAM) by the American public warranted a
focused effort at the National Institutes of Health (NIH). In 1998, NCCAM was
established through legislation as an independent Center with an Advisory
Council and grant-making authorities (Public Law 105–277, Title VI, Sec. 601).[1] The
1998 statute tasked NCCAM with the following specific major responsibilities
(among others):
"(a) The
general purposes of the National Center for Complementary and Alternative
Medicine are the conduct and support of basic and applied research (including
both intramural and extramural research), research training, the dissemination
of health information, and other programs with respect to identifying,
investigating, and validating complementary and alternative treatment,
diagnostic and prevention modalities, disciplines and systems. The Center shall
be headed by a director, who shall be appointed by the Secretary. The Director
of the Center shall report directly to the Director of NIH."
Comment: Note these foci: "treatment,"
"disciplines" and "systems." This language continues like a refrain
throughout the mandate, continuously calling a reader to the broader,
real world questions suggested by these research directions. Note also
the focus on "prevention" in the phrase "prevention modalities,
disciplines and systems." Congress knew that these "CAM" practices
promised a preventive focus in treatment. Congress told NCCAM to go and learn
about it. This language is repeated, in a similar form, 6 times in the
9 subsections of the mandate.
NCCAM, in its 2009 white paper, cites just 3 of the subsections, leaving out these that I include here in bold.
"(b)
Advisory Council.-The Secretary shall establish an advisory council for
the Center in accordance with section 406, except that at least half of
the members of the advisory council who are not ex officio
members shall include practitioners licensed in one or more of the
major systems with which the Center is concerned, and at least 3
individuals representing the interests of individual consumers of
complementary and alternative medicine."
US Senator Tom Harkin: key visionary on the NCCAM mandate
Comment: Notable
here is that Congress wished to set a very high level of influence from
clinician-researchers as differentiated from PhD basic science
researchers on the National Advisory Council for Complementary and Alternative Medicine.
Such a block of CAM-experienced clinicians might keep NCCAM focused on
the practical, clinical agenda described in the rest of the mandate,
and protect it from the predispositions of business-as-usual basic
scientists. (Interestingly, just 3 of NCCAM'S 18 members are presently
from the licensed CAM disciplines, which would seem to be the main
discipline and systems NCCAM was charged to explore, particularly since
"integrative medicine" was merely emerging at the time.) Congress also
wanted NCCAM well-connected with consumers and their practical
questions, reinforcing this through the requirement for 3
consumer representatives. In short, subsection (b) may be viewed as an
effort to protect this new entity from the customary, basic-science
orientation of NIH culture.
"(c) Complement to Conventional Medicine [This heading is in bold as it was not in the NCCAM white paper.] - In carrying out subsection (a), the Director of the
Center shall, as appropriate, study
the integration of alternative treatment, diagnostic and prevention systems,
modalities, and disciplines with the practice of conventional medicine as a
complement to such medicine and into health care delivery systems in the United
States."
Comment:Again we see an extraordinary, practical, real world focus: " ... the integration of alternative treatment ... into healthcare delivery systems in the United States." Congress
knew that CAM was already a $33-billion industry, and that hospitals,
health systems and insurers across the US were asking questions about
how to integrate these therapies and disciplines. Similarly, the
charge, repeated elsewhere, to look at "prevention systems" was because
Congress knew these fields claimed expertise in this area and that the
nation was in need of a shift in that direction. The research challenges are clearly in the outcomes and health-services arena as prioritized in (f) below. The 2009 NCCAM white paper
does not cite the following sub-sections (d), (e) and (f), all of which
indicate Congress' clarity that non-conventional expertise needed to
inform the new Center's mission.
"(d) Appropriate Scientific
Expertise and Coordination With Institutes and Federal Agencies.- The
Director of the Center, after consultation with the advisory council
for the Center and the division of research grants, shall ensure that
scientists with appropriate expertise in research on complementary and
alternative medicine are incorporated into the review, oversight and
management processes of all research projects and other activities
funded by the Center. In carrying out the subsection, the Director of
the Center, a necessary, may establish review groups with appropriate
scientific expertise. The Director of the Center shall coordinate
efforts with other Institutes and Federal agencies to ensure
appropriate scientific input and management."
Comment: Finding such "appropriate
expertise" was a challenge in 1998 as few federal funds had supported
research in CAM and integrative practice prior to that date; thus there
was not a readily available infrastructure for accessing such
expertise. The challenge was similar to that in naming members to
NACCAM in subsection (b) above. Yet
now, as we move into the
2010-2015 strategic plan, thanks to the experience of the last decade,
we have available subsets of new researchers from the licensed CAM
fields to fill these positions. We also have a few score of
clinically-experienced MDs from the field of integrative medicine which
has emerged in this past decade, as well as integratively-oriented
nurses with significant
clinical experience in integrative practice. NCCAM can more readily
find the "appropriate expertise" to inform the real world charge in the
1998 Congressional
prioritization as noted in (f).
"(e) Evaluation of Various Disciplines and Systems.-
In carrying out subsection (a), the Director of the Centers shall
identify and evaluate alternative and complementary medical treatment,
diagnostic and prevention modalities in each of the disciplines and
systems which the Center is concerned, including each discipline and
system in which accreditation, national certification, or a State
license is available."
Comment: Notably, in 1998, "integrative
medicine" was an emerging phrase but did not yet exist as an organized
field. Therefore the chief disciplines that fit the description of "accreditation, national certification, or a State license is available" are chiropractic medicine, acupuncture and Oriental medicine, naturopathic
medicine, massage therapy and direct-entry (homebirth) midwifery and
the hundred of thousands of licensed practices these professions
represented. (For more information on these professions and their
recognized agencies, go to the Organizational Members page of the Academic Consortium for Complementary and Alternative Health Care
and click into the member names or click on the logos on the left
side.) A very few among NCCAM's hundreds of grants directly explore
the whole practices of these licensed disciplines even as a limited
number were granted to explore the whole practices engaged by
integrative medical doctors, in integrative clinics and in hospitals
and community clinics. NCCAM has generated very little cost or clinical
evidence about the disciplines and systems which can give the delivery
systems, noted in (c) above, information about optimal use of these
practitioners and integrative practices.
"(f) Ensuring High Quality,
Rigorous Scientific Review.- In order to ensure high quality, rigorous
scientific review of complementary and alternative, diagnostic and
prevention modalities, disciplines and systems, the Director of the
Center shall conduct or support the following activities:
(1) Outcomes research and investigations. (2) Epidemiological studies. (3) Health services research. (4) Basic science research. (5) Clinical trials. (6) Other appropriate research and investigational activities."
Congress knew that integration begged cost issues
Comment: Congress, in its wisdom, listed
these types of investigations in this order. This list does not follow
the classic sequence of basic research then clinical trials then
effectiveness and outcomes and costs. Nor is it alphabetical. Rather,
Congress deliberately expressed its mandate in this order. In essence,
Congress urged NCCAM to jump, with both feet, into the real world of
effectiveness (#1) and cost (a likely interpretation of #3, especially
if NCCAM takes seriously the mandate to explore "integration ... into
delivery systems"). This focus may explain why NACCAM was to be loaded
with experienced clinicians. In practice, NCCAM has not prioritized
this order of research investment, nor has it made an attempt to even
give each equal measure. Rather, the types of research listed as #4 and
#5 have dominated, as is typical the NIH Institutes.
Most important for our purposes is to consider what the exclusion of this section (f) from Paper #1
means about NCCAM's anticipated direction for 2010-2015. Certainly, if
one were attempting to build a case for moving to a real world and
outcomes focus, as Briggs has sometimes articulated,
bringing this portion of Congressional intent forward would be
supportive. However, the list of "promising leads" for future research
in 2009 Paper #2: NCCAM Priority Setting-Framework and Other Considerations,
shows just how far from this Congressional prioritization NCCAM
anticipates sending its money in 2010-2025. These are the leads as
listed:
"Potential application of specific CAM approaches
to management of chronic pain
"Molecular targets of dietary small molecules
(e.g., quercetins, curcumin, and other polyphenols and flavonoids)
"Anti-inflammatory actions of omega-3 fatty acids
at clinically relevant concentrations
"Effects of cranberry juice on bacterial
adherence
"Availability of tools and methods to study the
effects of probiotics on the human microbiome
"Apparent relationships between acupuncture or placebo
analgesia and known and well-characterized endogenous opioid pathways
"Apparent engagement of major pathways of emotion
regulation by meditative practices
"Importance of the practitioner-patient interaction,
context effects, and the placebo response."
Bullet #1 on pain is potentially on target,
depending on how "specific" (read "reduced to something other than real
world practices") the strategy is. Bullets #2, #3, #4 and #5 are all
basic science questions relative to natural products. Bullet #6 and #7
both look like examinations of treatments but are basic science rather
than real-world outcomes oriented. The last bullet engages some
questions of the "whole system of care," though without a focus on
effectiveness or cost-effectiveness and the integration into the
current delivery system. The suggestion from this list, and the
exclusion of (f) from Paper #1, is that the momentum inside NCCAM on
the 2010-2015 strategic plan is not presently toward the outcomes and
health services prioritization Congress urged.
"(g) Data System; Information Clearinghouse.—
(1) Data Systems.—The Director of the Center shall establish a bibliographic system for
the collection, storage, and retrieval of worldwide research relating to complementary
and alternative treatment, diagnostic and prevention modalities, disciplines
and systems. Such a system shall be regularly updated and publicly accessible.
(2)
Clearinghouse.—The Director of the Center shall establish an information
clearinghouse to facilitate and enhance, through the effective dissemination of
information, knowledge and understanding of alternative medical treatment,
diagnostic and prevention practices by health professionals, patients,
industry, and the public."
(h) Research Centers.- The
Director of the Center, after consultaton with the advisory council for
the Center, shall provide support for the development and operation of
multipurpose centers to conduct research and other activities describes
in subsection (a) with respect to complementary and alternative
treatment, diagnostic and prevention modalities, disciplines and
systems. The provision of support for the development and operation of
such centers shall include accredited complementary and alternative
medicine research and education facilities.
Comment: The Center approach has recently been downplayed,
strategically, as I understand it, in recent years. Part of what is
important here, again, is the way Congress specifically included
language that some of the centers shall be at accredited CAM
facilities. Just two of over two dozen listed here were. Also notable is the inclusion of language that all centers, regardless of location, shall focus
on "diagnostic and prevention modalities,
disciplines and systems," not merely individual agents. Of the other
centers established, to my understanding, few engaged these areas of
inquiry to a significant extent.
(i) Availability of
Resources.-After consultation with the Director of the Center, the
Director of NIH shall ensure that resources of the National Institutes
of Health, including laboratory and clinical facilities, fellowships
(including research training fellowships and junior and senior clinical
fellowships), and other resources are sufficiently available to enable
the Center to appropriately and effectively carry out its duties as
described in subsection (a). The Director of the NIH, in coordination
with the Director of ht Center, shall designate specific personnel in
each Institute to serve as full-time liaisons with the Center in
facilitiating appropriate coordination and scientific input.
Comment: Credit NCCAM for creating an
array of grant programs and fellowships which have been made available
to support new researchers in the CAM fields, both from the distinctly
licensed CAM disciplines and from conventional academic centers. They
have also funded a series of R-25 education grants which directly
supported the development of research culture in the accredited CAM
schools, and another set of R-25 grants through which relationships
were created between accredited CAM schools and conventional academic
health centers. These directions, while relatively minor portions of
NCCAM's funding, need to be enhanced and carried forward. It would
serve Congressional intent if new fellowships particularly targeted
developing the kinds of expertise needed to do the outcomes and health
services research on disciplines, systems and integration into delivery
systems which Congress intended.
The final section (j) was not included in 2009 NCCAM Paper #1 and is
not important for our purposes, referring as it does only to mechanisms
of 1998 appropriations.
____________________________
Part II: 14 Reasons Why 2010 is Auspicious for a Real World NCCAM Agenda
NCCAM's Briggs: Will she put real money behind Congress' real world agenda?
Numerous developments this past decade in healthcare, in
research and in the complementary and alternative medicine and
integrative healthcare world make 2010 even more auspicious than 1998
for the approach Congress mandated. Here are 14.
Cost crisis in
US medicine As the portion of the GNP which is consumed by
medical expenditures grows, all research which helps us understand costs and
particularly potential contributions to cost savings rises in priority.
Comparative
effectiveness research This field, slowly emerging in recent years, gained
a huge boost through its embrace by the Obama administration and signals a
focus on findings which will influence decision processes on inclusion. The
orientation toward comparative research strategies is aligned with the real
world questions that are asked if NCCAM follows the Congressional mandate to
evaluate CAM integration into conventional medicine and mainstream delivery
systems. Decisions about integration are typically about comparative
effectiveness, and comparative cost-effectiveness. One good sign: NCCAM director Briggs is on a key NIH committee on the topic.
Growing respect
for the multi-factorial treatment of chronic diseases The scientific
and clinical community is increasingly aware that the optimal treatment plans
for individuals with the chronic conditions which are the most significant
contributors to the cost crisis integrate diverse inputs (diet, exercise,
pharmacological interventions, etc.) and typically various practitioners. From
the perspective of research methodology, these multi-factorial approaches ask
similar questions as must be asked to evaluate the disciplines and systems
involved in integrative healthcare and integrative medical practices. NCCAM’s strategies
for examining whole practices or whole systems can both advance, and gain from
the parallel efforts to develop appropriate research modeling for chronic
conditions.
Prevention, and
creating a “society of wellness”A sub-conversation among leading
healthcare reform advocates in Congress is the assertion that controlling costs
must begin with focusing more on prevention and, more generally, building what US Senator Tom Harkin calls a
society of wellness.NCCAM’s engagement of the mandate to evaluate “prevention" as it relates to "modalities,
disciplines and systems” presently enjoys a heightened profile as part of the
general health care dialogue.
Appreciation
that the best prevention is the same as the best treatment for chronic
conditions in primary care Researcher-clinician Edward Wagner, MD, the developer
of the chronic care model, argues that primary care must “increasingly
recognize that, for the 40 to 50% of the population suffering from chronic
conditions, the distinctions between prevention and treatment begin to break
down since the interventions are much the same.”(As paraphrased in Integrative Medicine and the Health of the Public: A Summary
of the February 2009 Summit, Institute of
Medicine, November 2009, page11.) This perspective is philosophically aligned with the clinical approach in
integrative practice/integrative medicine which has been articulated as
treating disease by restoring health. The research needs in the chronic care
model, and the related medical home model would both inform, and be informed
by, a prioritization of research on whole disciplines and whole systems.
New employer initiatives
relative to integrative medicine In the last decade, two significant
employer initiatives began focusing on the potential value of complementary,
alternative and integrative medicine in their efforts to create health in their
workforces. The most significant is the Corporate Health Improvement Program,
based at the Arizona Center for Integrative Medicine, which is focusing on
integrative medicine in its present, third phase. The other is the Institute
for Health and Productivity Management. These initiatives combine interest in
outcomes, cost and health creation and may create additional stakeholder
partners for NCCAM health services research relative to effectiveness, cost and
productivity gains.
Emergence of the
dialogue on whole systems research Another factor which supports increased
focus on the exploration of whole disciplines and systems in the 1998 mandate
is the emergence of a formal dialogue in the integrative medicine community
over what is generally known as “whole systems research.”
The dialogue and limited, funded research experience are creating a
community of scientists in integrative medicine and in the licensed CAM
disciplines who are readily available to help shape and carry out a
research focus on “prevention modalities, disciplines and systems.”
Easy
availability of resources on outcomes research Researchers on CAM and integrative
healthcare/integrative medicine who are targeting the #1 research activity
identified in the Congressional mandate, outcomes research, now have resources
available which were not in 1998, including the rich set of instruments and
dialogue developed by IN-CAM and available at www.outcomesdatabase.org.
Emergence of the
field of “integrative medicine” NCCAM’s white paper #1 includes a
significant section on the emergence of the field of integrative medicine, and
in particular “integrative medicine centers located at research-intensive
institutions can be important venues for the collaborative multidisciplinary
approaches needed to fully investigate and develop promising CAM interventions.”
This emergence is of a significant new stakeholder which is philosophically and
clinically committed to clinical prevention, whole practices (integrative medicine MDs who use a
combination of conventional and complementary and alternative modalities and
agents in their individual practices) and whole systems (integrative medicine
MDs who work in systems that integrate an array of conventional and CAM
practitioners). The field speaks of a preventive focus in clinical practice and
is also challenged with proving its value economically in order to gain coverage.
Deepening
dialogue on the need for more appropriate research methodology A 2009 report
from the British King’s Fund links the challenges in researching complementary
and alternative medicine with those for health enhancement: "It is our
belief that the specific difficulties we grappled with (relative to
complementary practices) reflect a more generic challenge: the challenge to use
a scientific approach to understand and test those things that we, as members
of the public, do to manage our health." A similar theme was repeated in
the IOM February 2009 Summit on Integrative Medicine and the Health of the Public.
This emerging consensus underscores the potential value of
NCCAM leadership in exploring the health-focused whole practice model.
Creation of CAM
and integrative medicine oriented practice-based research networks Another part of
the landscape which is in early stages of development, but which support the
effectiveness and cost agenda is the beginning of the development of
practice-based research networks in integrative medicine, via the Bravewell
Collaborative, a chiropractic network, via a HRSA grant, and a development of such a network in the naturopathic medical profession.
Emergence of
research capacity and advanced expertise in the licensed CAM disciplines Finally, a
significant trend in the last decade which can support the real world focus of the Congressional
mandate, is the maturation of the research community inside the CAM
disciplines. This decade of first significant NIH investment in the CAM
institutions, researchers and institutes associated with CAM schools, and the
inclusion of researchers from these fields and review panels has created a body
of recognized leaders and a shift in the culture of all the disciplines.
(The member of the Research Working Group of the Academic Consortium for Complementary and Alternative Health Care
have been investigators on over 50 NCCAM grants.) While NCCAM’s minimal
investment in effectiveness and cost-effectiveness research has limited
the experience of the this research community in carrying out studies
on outcomes, such an investment is believed by most to quickly draw
significant interest and increased participation from the integrative
practice fields.
Closing comments
– weighing NCCAM’s futures
As
noted in NCCAM’s white paper #1,
the Center is pulled in many different
directions amidst a “spectrum of political opinion.” On one side are
conservative, skeptical, conventional academic medical critics. The
strategic plan through which NCCAM can best please these critics is to
shut its door; short of that, try to get along by going along. The
strategy would be to adopt an
agenda which looks like the basic science and RCT approach which has
dominated NCCAM investment in the first decade.
Yes, at the "other end of the spectrum" are those who ask NCCAM to
engage the real world agenda which Congress mandated.
We need to prioritize this agenda with a fixed allocation of at least 45% of NCCAM funds.
Yet what has this Straus program got us? The child of these 10 years of chosen parenting is a paradoxical
creature. On one hand, the Straus method is saluted by the NIH
establishment and certain academics for giving CAM research legitimacy.
Note that it is "research legitimacy" rather than legitimacy as a part
of health care. For on the other hand, the outcomes of Straus strategy
suggest that the 40% of adult Americans who spend these billions on
these therapies and practitioners are utterly loony. As MSNBC routinely
editorializes in recent months: "Ten years and $2.5 billion in research have found no
cures from alternative medicine."NCCAM's antagonists still want to shut it down.
In truth, there can be great value from basic sciences. For instance, a
leading researcher, on hearing my rant, recently used this argument:
"Basic science
of
acupuncture, including neuroimaging etc. has done more to get people to
accept
the value of acupuncture than all the interventional trials to date."
But we really don't have to worry whether basic science research will be in the next
strategic plan. It will be. The question is “at the other end of the spectrum,” in the words of the 2009 NCCAM white paper, where we find those
who believe that:
“ ... NCCAM research fails to evaluate CAM as it is actually used in
‘real-world’ CAM practice settings, that there is insufficient support of CAM
practitioner involvement in the research process, that the field is dominated
by reductionist scientific approaches or inappropriate methodology, that the
peer-review process is biased against CAM … and that there has been
insufficient focus on health and wellness.”
By prioritizing this agenda, NCCAM can involve
itself, and CAM, in some
of the most exciting and potentially
valuable health care
initiatives
of our time.
I would reframe this statement this way: At the other end of the spectrum are those who ask NCCAM to
engage the real world agenda which Congress mandated. We need to prioritize this agenda with a fixed target of at least 45% of NCCAM funds.
By prioritizing this agenda, NCCAM can involve
itself, and CAM, in some of the most exciting and potentially valuable health care
initiatives of our time: the chronic care model, medical homes, comparative
effectiveness, multi-factorial and team care strategies, lifestyle change, prevention
and health creation. Such an agenda is likely to prove a
more direct path toward proving NCCAM’s value as an agency, and for drawing
more resources to it, than to embrace a strategic plan which is reduced to a few limited,
if important, questions.
Send your comments to
for inclusion in a future Integrator. More importantly,
send your stakeholder comments to NCCAM.
Part III: The NCCAM Mandate Straight Up
112 STAT. 2681–387 PUBLIC LAW 105–277—OCT. 21, 1998
TITLE VI—NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE
SEC. 601. ESTABLISHMENT OF NATIONAL CENTER FOR COMPLEMENTARY
AND ALTERNATIVE MEDICINE.
IN GENERAL.—Title IV of the
Public Health Service Act (42 U.S.C. 281 et seq.) is amended—(1) by
striking section 404E; and (2) in part E, by adding at the end the
following:‘‘Subpart 5—National Center for Complementary and Alternative Medicine
‘‘SEC. 485D. PURPOSE OF CENTER.
‘‘(a)
IN GENERAL.—The general purposes of the National Center for
Complementary and Alternative Medicine (in this subpart referred to as
the ‘Center’) are the conduct and support of basic and applied research
(including both intramural and extramural research), research training,
the dissemination of health information, and other programs with
respect to identifying, investigating, and validating complementary and
alternative treatment, diagnostic and prevention modalities,
disciplines and systems. The Center shall be headed by a director, who
shall be appointed by the Secretary. The Director of the Center shall
report directly to the Director of NIH.
‘‘(b)
ADVISORY COUNCIL.—The Secretary shall establish an advisory council for
the Center in accordance with section 406, except that at least half of
the members of the advisory council who are not ex officio members
shall include practitioners licensed in one or more of the major
systems with which the Center is concerned, and at least 3 individuals
representing the interests of individual consumers of complementary and
alternative medicine.
‘‘(c)
COMPLEMENT TO CONVENTIONAL MEDICINE.—In carrying out subsection (a),
the Director of the Center shall, as appropriate, study the integration
of alternative treatment, diagnostic and prevention systems,
modalities, and disciplines with the practice of conventional medicine
as a complement to such medicine and into health care delivery systems
in the United States.
‘(d)
APPROPRIATE SCIENTIFIC EXPERTISE AND COORDINATION WITH INSTITUTES AND
FEDERAL AGENCIES.—The Director of the Center, after consultation with
the advisory council for the Center and the division of research
grants, shall ensure that scientists with appropriate expertise in
research on complementary and alternative medicine are incorporated
into the review, oversight, and management processes of all research
projects and other activities funded by the Center. In carrying out
this subsection, the Director of the Center, as necessary, may
establish review groups with appropriate scientific expertise. The
Director of the Center shall coordinate efforts with other Institutes
and Federal agencies to ensure appropriate scientific input and
management.
‘‘(e)
EVALUATION OF VARIOUS DISCIPLINES AND SYSTEMS.—In carrying out
subsection (a), the Director of the Center shall identify and evaluate
alternative and complementary medical treatment, diagnostic and
prevention modalities in each of the disciplines and systems with which
the Center is concerned, including each discipline and system in which
accreditation, national certification, or a State license is available.
‘‘(f)
ENSURING HIGH QUALITY, RIGOROUS SCIENTIFIC REVIEW.— In order to ensure
high quality, rigorous scientific review of complementary and
alternative, diagnostic and prevention modalities, disciplines and
systems, the Director of the Center shall conduct or support the
following activities: ‘‘(1) Outcomes research and investigations. ‘‘(2) Epidemiological studies. ‘‘(3) Health services research. ‘‘(4) Basic science research. ‘‘(5) Clinical trials. ‘‘(6) Other appropriate research and investigational activities. The
Director of NIH, in coordination with the Director of the Center, shall
designate specific personnel in each Institute to serve as full-time
liaisons with the Center in facilitating appropriate coordination and
scientific input.
‘‘(g) DATA SYSTEM; INFORMATION CLEARINGHOUSE.— ‘‘(1) DATA SYSTEM.—The Director of the Center shall establish a bibliographic system for the collection, storage, and
retrieval of worldwide research relating to complementary and
alternative treatment, diagnostic and prevention modalities,
disciplines and systems. Such a system shall be regularly updated and
publicly accessible. ‘‘(2) CLEARINGHOUSE.—The Director of the Center shall establish an information clearinghouse to facilitate and
enhance, through the effective dissemination of information, knowledge
and understanding of alternative medical treatment, diagnostic and
prevention practices by health professionals, patients, industry, and
the public.
‘‘(h) RESEARCH
CENTERS.—The Director of the Center, after consultation with the
advisory council for the Center, shall provide support for the
development and operation of multipurpose centers to conduct research
and other activities described in subsection (a) with respect to
complementary and alternative treatment, diagnostic and prevention
modalities, disciplines and systems. The provision of support for the
development and operation of such centers shall include accredited
complementary and alternative medicine research and education
facilities.
‘‘(i)
AVAILABILITY OF RESOURCES.—After consultation with the Director of the
Center, the Director of NIH shall ensure that resources of the National
Institutes of Health, including laboratory and clinical facilities,
fellowships (including research training fellowship and junior and
senior clinical fellowships), and other resources are sufficiently
available to enable the Center to appropriately and effectively carry
out its duties as described in subsection (a). The Director of NIH, in
coordination with the Director of the Center, shall designate specific
personnel in each Institute to serve as full-time liaisons with the
Center in facilitating appropriate coordination and scientific input.
‘‘(j)
AVAILABILITY OF APPROPRIATIONS.—Amounts appropriated to carry out this
section for fiscal year 1999 are available for obligation through
September 30, 2001. Amounts appropriated to carry out this section for
fiscal year 2000 are available for obligation through September 30,
2001.’’.
(k) TECHNICAL AND
CONFORMING AMENDMENT.—Section 401(b)(2) of the Public Health Service
Act (42 U.S.C. 281(b)(2) is amended by adding at the end the following:
112 STAT. 2681–389 PUBLIC LAW 105–277—OCT. 21, 1998 ‘‘(F) The National Center for Complementary and Alternative Medicine.’’’.
