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Minutes of the Third Meeting - May 8-9, 2000
National Advisory Council for Complementary and
Alternative Medicine (NACCAM)
On this page:
- Call to Order and Meeting Procedures
- Introduction of Members
- Future Meeting Dates
- Review of Confidentiality and Conflict of Interest
- Director’s Report and Overview of Draft Strategic Plan
- Development of a Trans-NIH Health Disparities Agenda
- Public Comment
- Proposed Program Initiatives
- Call to Order
- Review of Applications
- Adjournment
The National Advisory Council for Complementary and Alternative Medicine
(NACCAM) convened at 8:30 a.m. on May 8, 2000, at the National Institutes
of Health (NIH) Neuroscience Office Building in Rockville, Maryland. Richard
Nahin, Ph.D., M.P.H., Executive Secretary of NACCAM, called the meeting
to order. The meeting was open to the public from 8:30 a.m. until 5:15
p.m. on May 8. The meeting was closed to the public on May 9 from 8:30
a.m. until adjournment as provided in Sections 552b(c)(4) and 552b(c)(6),
Title 5 U.S. Code, and section 10(d) of Public law 92-463, for the review,
discussion, and evaluation of grant applications and related information.
NACCAM Members Present (1)
- Dr. Brian Berman
- Dr. Michael Cantwell
- Dr. Richard Grimm
- Ms. Susan Holloran
- Dr. Janet Kahn
- Dr. Konrad Kail
- Dr. Ted Kaptchuk
- Dr. Dana Lawrence
- Ms. Diana Manley
- Dr. William Meeker
- Dr. Karen N. Olness
- Dr. Everett Rhoades
- Dr. Marilyn Schlitz
- Dr. Leanna Standish
- Col (ret) James E. Williams, Jr.
NACCAM Members Absent
- Ms. Mary Chung
- Dr. Herbert Pardes
- Dr. Gilbert Ramirez
NIH Staff Members
- Dr. Sheryl Brining, NCCAM
- Dr. John Chah, NCCAM
- Ms. Marguerite Evans, M.S., R.D., NCCAM
- Ms. Anita Greene, M.S., NCCAM
- Dr. Eugene Hayunga, NCCAM
- Ms. Christine Hollingsworth, M.B.A., NCCAM
- Mr. Doug Hussey, NCCAM
- Dr. Yvonne Maddox, NIH OD
- Mr. Steve LeBlanc, NCCAM
- Dr. Kim Pham, NCI
- Mr. Charles Sabatos, NCCAM
- Dr. Stephen Straus, M.D., NCCAM
- Dr. Christine Swanson, ODS
- Ms. Shirley Villone, NCCAM
- Dr. Neal West, NCCAM
- Dr. Jeffrey White, NCI
- Ms. Suzanne White, NHLBI
- Mr. Patrick Williams, NIH OD
DAY ONE - MAY 8, 2000
I. Call to Order and Meeting Procedures
The meeting was called to order at 8:30 a.m. by Dr. Richard Nahin, Executive
Secretary, NACCAM. He
introduced Brian Berman, M.D., who was serving on the Council as an ad
hoc member. Dr. Nahin
discussed the procedures NACCAM council members must abide by and addressed
the requirements of
working under federal laws regarding open and closed sessions. The Monday
session was to be open to
the public, while the Tuesday session, during which individual grant applications
would be reviewed, was to
be closed and the material discussed confidential. Closed sessions were
to follow federal guidelines. There
would be an opportunity for public comment, as required by law. Dr. Nahin
then gave a brief overview of
the conference’s agenda, including discussion of the National Center for
Complementary and Alternative
Medicine draft strategic plan, the NIH’s Health Disparities initiative
and numerous concept clearances.
II. Introduction of Members
Council members introduced themselves and stated their areas of expertise.
III. Future Meeting Dates
Dr. Nahin reminded members that the dates for the next council meeting
are August 28 and 29. At the
January Council, there had been a discussion of having mail reviews in
lieu of a fall meeting. At that time
Council had determined it would continue to meet in person for second
level peer-review. Therefore, a
meeting has been scheduled for November 13 and 14. Meeting dates have
been established through
August 2002.
IV. Review of Confidentiality and Conflict of Interest
Dr. Nahin reviewed conflict of interest and confidentiality requirements
in brief, stating that they would go
over this issue again on Tuesday, before the actual review of applications.
A conflict of interest may occur
when any of the following exist: (1) the member has a designated role
in the research; (2) the member has a
self-interest—professional or financial—in the research results;
(3) there is even an appearance of conflict
stemming from participation of a family member or associate of the NACCAM
member. In addition, when
an institution with which the reviewer is affiliated has an application
under review, there is the appearance
of conflict of interest even if the reviewer will not benefit financially
and knows none of those involved in the
proposed project. If any of these conditions were present, the NACCAM
member was to withdraw from
the discussion to prevent the proceedings from having an appearance of
bias. Members are to refrain from
discussing meeting topics outside the forum of NACCAM meetings. The review
process should not be
discussed with applicants; to do so would be a disservice to them and
other applicants. If reviewers are
contacted by applicants, the reviewers should refer them to NCCAM staff.
Furthermore, committee
members must not keep any materials distributed in a closed session. These
materials must be left behind
since they contained confidential information.
V. Director’s Report and Overview of Draft Strategic Plan
Dr. Straus presented an overview of the NCCAM draft strategic plan.
The draft plan was to be posted on the NCCAM web site for six weeks, starting
May 10, in order for the public to make comments.
NCCAM staff will then assemble the comments.
At this time, there are research opportunities in the area of public
health since complementary and
alternative medicine (CAM) practices are increasingly available to the
public. Some of these practices may
sustain or improve health, while some may not. The public deserves definitive
guidance as to which
practices are safe and effective.
As mandated in the establishing legislation, P.L. 105-277, NCCAM is
charged with the "conduct and
support of basic and applied research (intramural and extramural), research
training, and disseminate health
information and other programs with respect to identifying, investigating,
and validating CAM treatments,
diagnostic and prevention modalities, disciplines and systems." The
mandate has been supported by
increasing funding, which has gone from $2 million in 1993 for the Office
of Alternative Medicine to $68.7
million for NCCAM in fiscal year 2000.
NCCAM must engage in a proactive planning process by creating opportunities,
rather than setting up
hoops for investigators to jump through. In being proactive, NCCAM must
solicit the best ideas from
stakeholders, including Council, and from within NCCAM, give the best
ideas a chance to mature,
organize and rank these best ideas, tie the priorities to a rational budget,
and secure buy-in from stakeholders.
There are many stakeholders, with much external input into NCCAM decision-making.
NCCAM staff
hears from the White House, Congress, consumers, medical, industry, researchers,
CAM practitioners,
advocacy groups, and other NIH institutes. These interactions have helped
NCCAM staff to outline the
strategic plan and set goals. The priority-setting process moves from
the strategic plan to the annual
research plan to research initiatives to specialized research plans.
Dr. Straus explained how the annual plan reflects the NIH planning cycle
by presenting a hypothetical cycle
leading to awards in a "Fiscal Year 4." In Fiscal Year (FY)
1, there is a July planning retreat for NCCAM
staff where research opportunities are discussed; the following January
(FY2), there is a program review to
firm-up which research opportunities will be developed into concept clearances
for FY4 funding. In of
FY2, NCCAM staff submits a preliminary budget to the NIH Office of the
Director for FY4. In May of
FY2, Council conducts concept clearance reviews. In July of FY2, the concept
clearances approved by
Council are reviewed at a staff planning retreat, then worked into initiatives
to be released in FY3. Finally,
awards are made in FY4. All this time, staff are getting stakeholder input.
Therefore, the strategic plan plays a critical role as a guiding document.
Elements of a strategic plan include
the following:
Mission: What is our fundamental purpose?
Customers: To whom are we accountable?
Vision: What is our direction?
Goals: How do we get there over a period of time?
Objectives: What short term priorities will move us toward our goals?
Actions: What efforts are required to move us forward?
Results: How will we determine our progress?
NCCAM strategic areas include: investing in research; training CAM investigators;
expanding outreach;
facilitating integration of safe and effective practices and eliminating
unsafe practices; and practicing
responsible stewardship. The research aspect reflects that this is an
NIH organization, for research is an
NIH priority. Training is important because CAM is a new area of investigation.
The results of CAM
research need to be articulated clearly to public, which leads to outreach.
This in turn will lead to the
integration of safe and effective CAM practices into traditional medicine.
Responsible stewardship is the
overall NCCAM responsibility.
Investing in research involves acquiring more high-quality applications
in priority areas; expanding the
NCCAM research portfolio; establishing a global NCCAM research enterprise;
creating an NCCAM
intramural research program; and encouraging the participation of diverse
consumers in clinical studies. The
portfolio should be broad. Global reach is necessary because some research
will be done in other
countries. The intramural research program is one of the key elements
of the federal science enterprise.
In science, the hierarchy of evidence moves from anecdotes to case studies,
observational studies,
uncontrolled trials, small Random Controlled Trials (RCTs), systematic
reviews, and large RCTs. The goal
is to move through the hierarchy, from good ideas to compelling ideas,
with proof as a critical element.
In setting research priorities, NCCAM considers a number of criteria,
which include examining
interventions with the most credible preliminary data; using the simplest
study designs; considering the
ability to learn new science; looking at use by the U.S. public; considering
the public health impact;
acquiring adequate patient volunteers; determining the availability of
methodological expertise; and keeping
the study cost reasonable.
Scientific opportunities abound. Current and planned RCTs can also be
used to: (1) develop information
on the natural history of disease; (2) test biomarkers as more rigorous
outcome measures than subjective
rating scales; (3) define drug pharmokinetics; (4) identify the active
components of natural products; (5)
determine underlying mechanisms for action; and (6) study the placebo
effect. It was noted by Council that
a two-day workshop was planned for November 20 and 21 to promote greater
understanding of placebo effects.
Dr. Straus continued his presentation by highlighting several of the
current NCCAM program areas. The
first program area, the Frontier Medicine research program, is a mechanism
to identify and test CAM
modalities for which there is little formal evidence for benefit, but
for which there is substantial public interest.
Training was the second program area discussed by Dr. Straus. Training
of CAM investigators involves
increasing the number, quality, and diversity of such researchers. The
training strategy incorporates
individual and institutional awards while supporting careers from predoctoral
to midcareer. There will be
mentored and independent research covering basic and clinical research.
Dr. Straus then discussed outreach by NCCAM staff. Outreach involves
establishing a dialogue with
stakeholders and making information available to the public. Means for
the latter include the NCCAM
website, an information clearinghouse, CAM consumer and scientific databases,
the NCCAM newsletter,
and town meetings. Stewardship necessitates development of NCCAM human
resources, effective
management practices, and efficiency.
Dr. Straus turned the presentation over to Camille Hoover, Executive
Officer of NCCAM, to discuss
administrative stewardship. Concerning human resources, the NCCAM priority
is to recruit and retain a
qualified workforce that has the authority, accountability, and autonomy
necessary to meet the demands of
a growing organization. In order to bring in the best possible personnel
for the organization, NCCAM must
emphasize career development, the quality of the work life at NCCAM, and
diversity practices. Having the
right staff in place is critical to moving the organizational mission
forward. Therefore, leadership and
management practices must be based on an administrative infrastructure
that supports the science,
enhances services, and fosters a team environment. NCCAM staff must also
be efficient, in order to
accommodate rapid growth. This entails evaluating standards, streamlining
the work flow, establishing
service agreements with other Institutes and Centers (ICs), and encouraging
innovation and creativity. As
an example, Ms. Hoover discussed past problems with Council reimbursement
and how NCCAM might
rectify this issue.
Dr. Nahin spoke about stewardship of the NCCAM research portfolio. The
role of the scientific staff is to:
(1) identify scientific research needs; (2) identify and fund the best
science; (3) safeguard scientific
productivity; and (4) protect the NIH investment. In arranging to receive
applications, NCCAM must
consider that many potential investigators have never submitted proposals
to NIH before. Therefore,
NCCAM staff must help applicants understand how to apply while taking
into account the needs and
experience of potential applicants.
In receiving and assigning applications, the scientific review administrators
take great pains to guarantee
that the reviews provide high quality feedback to applicants. It is of
special important to ensure the
accuracy of the assignment to the Initial Review Group (IRG). Before Council
review, NCCAM staff must
identify applications requiring special actions. "Special actions"
might be required by size, funding, animal
testing, or gender or minority aspects. For second-level peer review,
staff tries to match each application to
a Council member with appropriate expertise.
Dr. Straus resumed with his presentation. The NCCAM budget is being
apportioned differently as the
funding levels increase. Some components are stabilizing, some are growing,
and some are dropping, by
percent. There will be a disproportionate growth of investigator-initiated
projects, and centers will account
for a smaller percentage of the total budget, bringing NCCAM more in line
with the NIH averages.
Investigator-initiated grants are expected to make up much of the increase.
Dr. Straus asked the Council for questions and comments on the strategic
plan. Dr. Herbert Pardes, who
was unable to attend but who was available via conference call, stated
that he endorsed the plan, finding it
in good balance. Dr. Berman said that the plan was excellent and innovative.
He suggested that when
looking at stewardship, NCCAM note the need for self-care by NCCAM’s own
people. Dr. Straus noted
that they have some quality of life initiatives within the range of what
the government allows, but they are
open to additional ideas. Dr. Berman then suggested that they focus on
definitions, starting with CAM and
allopathic or conventional medicine. Dr. Cantwell had no comments. Dr.
Grimm found the plan balanced,
although he did feel that in the area of CAM, the emphasis on training
should be stronger than in other
institutes because of need to develop trained investigators. Dr. Straus
agreed that this would be happening.
Ms. Holloran had a number of comments. She felt that the definitions
should be more precise, in terms of
what was meant by "visions," "goals," and the like.
She thought that the document had pieces of strategy
but was more of a plan. Her other main issue was with the cover statement
("From Many Traditions -
Toward One Medicine"). She did not agree with this statement and
noted that the Council had not agreed
upon it. She suggested that since the Council is relatively new, they
have their own meeting. Dr. Kahn said
that the procedure felt odd, as though no dialogue were taking place.
She, too, wanted to discuss
definitions, including that of conventional medicine. She also wanted
to see more emphasis on training. She
found that the studies thus far tend to fund what can be readily investigated,
which did not reflect her sense
of the public interest. She therefore wanted to see the agenda broadened.
Dr. Kail wanted an idea of the percentages of areas funded, specific
diseases addressed, and so forth. Dr.
Nahin commented that some of these data would be presented later in the
meeting. He found the second
iteration of the plan to be a great improvement. His main concern was
the mandate and what had been
funded. Although he found a good congruence between the two, he did not
think the plan reflected the
mandate precisely. He was also concerned that the topic of integration
was being addressed more in terms
of the interests of the allopathic community rather than the CAM community.
He noted that the obligation is
to look at whole protocols, expressing concern that if they dissected
down to single agents, they would
miss what was really happening in alternative medicine. He added that
he believed some of the concepts
they would be addressing for clearance later in the day should really
be with other agencies.
Dr. Kaptchuk had no comment. Mr. Williams agreed with Dr. Kail to a
certain extent, but he was waiting
to see what would evolve. He thought they were doing the best they could,
but he was not sure yet. He
noted that they should think outside the box. Dr. Schlitz was satisfied
with the process of developing the
plan, as well as the feedback process. She agreed with Dr. Kail regarding
some of the particular initiatives,
and said she wanted to take a more holistic approach, with an emphasis
on the goals of the healer-patient
interactions. She agreed with the shift in emphasis regarding investigator-initiated
programs and training.
She wanted to know the role of the White House task force on CAM and wanted
to look more at
prevention. She had some concerns regarding definitions, particularly
of the word "energy."
Dr. Standish found the plan to be a compelling document. Her main concern
was that they risked losing the
best and most complex ideas by depending on the conventional medicine
community to do evaluations. She
also wanted to see them focus less on "hardware" and more on
"software" such as the patient-healer
relationship. Dr. Straus noted that NCCAM responds to the best applications
it gets; as competition in
field increases, good applications will be submitted that address whole
systems. He reiterated his wish that
if members of the Council have concepts of what they want to pursue, they
inform the NCCAM staff, and
that they assert themselves when they review applications.
Dr. Meeker added that the Council is a recommending body, not policy
making body. He believed the
NCCAM staff was responsive, and that they can only evaluate the applications
they receive. He added
that it may be impossible to settle all the definition issues to the satisfaction
of everyone. Ms. Manley
expressed concerns about definitions, but stated that she thought the
draft strategic plan was a good
beginning. Dr. Lawrence felt the draft had improved from the first version.
He added that strategic plans
are general by nature and do not provide specifics, but rather provide
frameworks. Dr. Olness observed
that NCCAM has a unique opportunity to set the standard in cross-cultural
collaboration, and requested
sensitivity training on that issue.
Dr. Straus asked the Council if they had any more specific comments.
Dr. Berman suggested that they
would need to have some early successes while making room in the portfolio
for research in more
innovative areas. He perceived a need to examine both single agents and
whole systems. Dr. Cantwell
raised concerns about being co-opted in the course of integration. He
stated that patients care whether
medicine works, not of its origin. He suggested that NCCAM try to make
a "larger tent" with room for
individual systems. He emphasized that the public cares about getting
better more than anything else.
Ms. Holloran questioned whether or not they had a consensus on the cover
statement; she did not believe
there was one. She did not like the notion that integration would occur
in terms of a merger of CAM and
allopathic medicine. She also disliked the implication of co-optation,
with CAM elements added to
allopathic medicine; she said this would be counter-productive, and wondered
whether CAM modalities
would continue to exist. Dr. Meeker agreed there were concerns in this
area, but in his view, patients want
value, access to information, and choice. He stated that NCCAM would not
be making policy, but rather
helping policymakers come up with decisions.
Dr. Kail explained that many CAM practitioners would see the strategic
plan in terms of the Flexner
report. His concern was that the plan could be seen as exclusionary, not
inclusionary. Dr. Kail stated that
NCCAM cannot lose the trust of the CAM community. In order to avert a
problem, NCCAM needs to
assure that research support is provided to the CAM community. Dr. Straus
agreed that it is necessary that
all healing communities be able to contribute. Dr. Schlitz said that they
need to make the distinction
between diversity and pluralism: diversity is reality, pluralism is a
philosophy that appreciates differences
and the benefits of coexisting. She would like to see more of an "umbrella"
approach, rather than
integration. Dr. Lawrence added that the mission statement addresses this
very explicitly.
Dr. Kahn urged the Council to look at multiple models for patient opportunities.
Dr. Grimm noted that their
job is to evaluate treatments, and since CAM is a shifting target, they
need to take a treatment perspective.
Rather than get involved in territorial jockeying, their goal should be
to evaluate treatments with measurable outcomes.
Dr. Kaptchuk agreed, noting that politics and power issues are inevitable.
But the NIH mandate is to do
science, so a focus on treatment is the best idea. The issue of who owns
medicine is really one of who has
the power to allocate resources. He believed the plan tried to deal with
that in constructive way. Dr.
Cantwell suggested altering the title to something like "from many
traditions toward optimal health" as more
reflective of the NCCAM goal. Altering the phrase to "toward one
healing" would address concerns of the
CAM community.
Dr. Straus pointed out that in terms of priorities, the document lacked
specificity, and that was by design. If
they focused on one priority, they would come under criticism for neglecting
another. Dr. Kaptchuk
suggested they have nurses read the document. Dr. Straus explained that
they had done that already. In the
six weeks that the draft plan would be online for comment, anyone could
examine it and present their observations.
VI. Development of a Trans-NIH Health Disparities Agenda
Dr. Straus introduced Dr. Yvonne Maddox, Acting Deputy Director of NIH,
who discussed how NIH is
dealing with health disparities. She is leading a trans-NIH initiative
on this topic. NIH has identified six
high-priority areas with a view to eliminate racial and ethnic disparities
by 2010: infant mortality, cancer
screening and management, cardiovascular and diabetes, HIV/AIDS, and immunizations.
Dr. Maddox
reviewed the history of this issue, dating back to a scathing report on
health disparities from 1985. The
NIH group charged with this mission presented a strategic research agenda
report to the NIH Director in
December of 1999. The new acting Director of NIH wanted all IC directors
to be active partners on this
topic. Dr. Maddox is co-chair with Dr. Anthony Fauci, Director of the
National Institute of Allergies and
Infectious Disease. Each institute now has a strategic plan; all but four
were delivered in early April.
Health disparities are differences in the incidence, prevalence, mortality,
and burden of diseases and other
adverse health conditions that exist among specific population groups
in the United States. The domestic
focus is on socioeconomic subpopulations and ethnic minorities: black,
Hispanic, Native American, Asian,
and Pacific Islanders. They have found, for example, that Asian Americans
are more prone to cancer, and
asthma is significantly more prevalent among black children than white.
The plan of action involves: developing a 5-year strategic research
agenda; recruiting and training minority
investigators; advancing community outreach; bridging and forming partnerships;
evaluating progress; and
enhancing public awareness. NIH needs to make sure these populations understand
that clinical trials are
not only experiments, but also sources of excellent care. The plan of
action will address research on
diseases and conditions associated with health disparities, while expanding
recruitment of minorities in
clinical research and clinical trials, and on the NIH campus as well.
Another goal is the training and career
development of more minority scientists, which will entail building new
partnerships with minority
institutions; increased representation of minorities on peer review panels;
and enhanced recruitment of
minorities on positions on NIH campus. Meanwhile, the plan calls for establishing
new partnerships with
industry, foundations, and other federal agencies to advance progress
in eliminating health disparities, and
enhanced dissemination of public information and outreach. Dr. Maddox
explained that the plan had been
reviewed by advisory councils, professional societies, and advocacy groups.
The draft plan was to be
posted on the NIH web site for comments that week.
Dr. Nahin stated that Morgan Jackson, M.D., has been identified to develop
the NCCAM Office for
Special Populations starting this summer. Dr. Kaptchuk raised the issue
of accountability in this project. He
noted that informed consent did not exist in this country until 1966.
Prior to that, minorities were often
victims of scientific experiments, which has subsequently resulted in
their reluctance to participate.
Therefore, Dr. Kaptchuk maintained, there must first be accountability
of those who misused minorities in
this sense. Dr. Maddox agreed that the informed consent form must focus
on the knowledge of the patient,
and that more structure is necessary.
Dr. Standish asked if there was guidance on how to recruit more minorities
into clinical trials. Dr. Maddox
responded that there were several models, such as the study on heart disease
and stroke in African
Americans in Jackson Mississippi. Not only did the investigators present
seminars to minority populations,
they also went door-to-door to discuss the study and to make sure that
patients didn’t forget their
appointments. The investigators even provided transportation. But trust
remained a factor, and there is still
a need to build trust. Dr. Maddox said their office will incorporate additional
recruiting and maintaining
mechanisms such as town meetings and regional workshops. If the target
population is not on board, it
doesn’t matter how well a study is designed. It would help to give indigenous
investigators ownership of
these projects. Therefore, community outreach and community involvement
are necessary elements in good
trial design.
Council adjourned for lunch at 12:30 p.m.
VII. Public Comment
The meeting resumed at 1:30 p.m., and began with the period set aside
for public comment. The first
speaker was Beth Clay, a professional staff member for the Government
Reform Committee of the U.S.
House of Representatives. She stated that NCCAM could do a better job
of informing the public of the
meetings, possibly via e-mail. Her committee wanted to know where the
investment in NCCAM had gone,
and would like to see that on the web site. She also wondered whether
NCCAM was being kept current
about relevant activities by other institutes; the Council and the public
need to know what else is going on
at NIH. She asked if NCCAM had been working with the White House Commission
on CAM. She
suggested that NCCAM use means in addition to the web site to make the
strategic plan available to those
wanting to comment. One concern of her committee is how to pay for alternative
care for patients.
Dr. Sandra McLanahan, a physician in integrative medicine, spoke next.
The most interesting questions,
she suggested, are who are we and what are we doing with our time on earth.
Most people are sick
because of cigarettes, alcohol, bad diet, and stress. She would like to
see NCCAM review grant
applications with that in mind. She added that love is the most important
thing in the world. The idea of
spirituality is hard to grasp as scientists, but it is part of their job.
She has worked on bringing
compassionate care to dying people, which is what the whole journey is
about. She would like to see the
use of CAM therapies in that setting, and she would like to see an examination
of the healing power of
music for those in comas and in surgery. She would like to see NCCAM bring
in all our traditions, catch
up to what the general public is doing, and look at creating something
new. She suggested adding these
words to the cover statement: "integrating health." She also
stated that the NCCAM budget is less than
one-half of one percent of the total NIH budget, although more than forty
percent of Americans are using
alternative medicines.
Dr. Leila Saldanha, Vice President of Nutritional Sciences for the Consumer
Healthcare Products
Association, was the final speaker from among the public. Her recommendation
for the title of the strategic
plan was "from many practices to one goal," which would cover
all the traditions leading to safe, effective
outcomes. She recommended the plan be designated as a five-year strategic
plan. She believed that a
limitation in the plan is that it does not address current marketplace
concerns about the industry, especially
a negative backlash toward CAM. She feels that industry is not being represented
well at these meetings.
The public is concerned about safety and efficacy data. The previous year
saw a decline in the growth of
botanicals. She would like to see language supporting and promoting the
safe and effective use of these products.
Ms. Holloran suggested that Council perhaps have time to address comments
from the public. She noted
that there is a subcommittee for dissemination, and they are open to input.
Dr. Kail said that he would like
to see the herbal products companies become involved in these studies
like the drug companies do in the
traditional medicine areas. He maintained that herbal companies should
have a larger presence and should
share expenses, as they are making a lot of money from their products.
Dr. Saldanha explained that there is
concern about the ownership of data; if they share, it becomes public
data. Dr. Kail explained that some
natural products have patents, so protection is available. Dr. Straus
added that NCCAM is very interested
in working with industry. Dr. Cantwell, addressing Dr. McLanahan’s comments,
noted that there are
studies on love, and it can be studied.
VIII. Proposed Program Initiatives
Before discussing the specific concepts for clearance, Dr. Nahin spoke
about where the various concepts
fall in an overview of the CAM continuum. Frontier therapies, which are
the least validated, have few, if
any, random controlled trials (RCTs), and the mechanisms under which they
work are unknown. Thus far,
NCCAM has cleared concepts for several studies in this area, including
the Traditional, Indigenous
Systems of Medicine; Traditional Medicine in Developing Countries; and
Frontier Medicine. Emerging
therapies are characterized by small RCTs and mechanisms that are proposed
and under study. The
example given was that of Mind-Body therapies for the treatment of disease.
Transitional therapies are the
most validated, with definitive trials underway or completed and mechanisms
that are well-studied.
Acupuncture for management of acute pain is an example of a transitional
therapy; several concepts to be
presented at the current meeting, for example chromium to treat diabetes
and magnesium to treat asthma,
would be considered transitional. The goal is to fund protocols along
the whole spectrum from frontier to
transitional therapies. Dr. Nahin noted that the chromium and magnesium
studies are part of the heath
disparity initiative, since the diseases affect minorities more than whites.
Dr. Nahin finished by stating that
the continuum is just one possible way to categorize CAM and is not intended
as a definitive statement.
Dr. Kahn questioned the placement of acupuncture in the transition category.
Dr. Nahin observed that
there is a fair amount of information on the use of acupuncture for pain
management. These data do not
affect the placement on the continuum of acupuncture in other capacities.
Dr. Grimm questioned the use of
mechanisms as a qualifier, and Dr. Nahin noted that, right or wrong, CAM
treatments are held to the
highest level of proof. Dr. Grimm added that not all FDA-approved drugs
meet that level of proof. Dr.
Schlitz endorsed the construct, adding that standard NIH peer- review
groups have dismissed CAM
studies out of hand because they lacked a mechanistic paradigm.
Dr. Marguerite Evans of NCCAM presented the concept review for chromium
to treat diabetes. Most
studies thus far show that chromium supplements lowers the blood sugar
of those without diabetes. For
those with diabetes, studies so far indicated that chromium had a positive
impact. Most studies with no
effect have used low doses of chromium, or there were issues with the
study duration or the causes of
diabetes. Overall, chromium appears to be safe and to have a positive
affect on people with diabetes.
NCCAM plans to move beyond previous studies.
Dr. Kail stated that he would vote against doing this study. He believes
it should be done, but not by
NCCAM. He does not want NCCAM to be doing single agent trials, and will
hold that position on other
project concepts. This is a simple drug study. NCCAM has few funds; other
institutes have more money
for this kind of thing. Dr. Kail reiterated his belief that NCCAM should
look at whole protocols.
Dr. Grimm liked the concept, but was concerned about what other therapies
the patients would follow. He
cautioned that insulin sensitivity can be very difficult to gauge. He
also wanted to know what kind of center
would do this—a clinical center? He suggested they look at the National
Heart, Lung and Blood Institute
model, in which centers apply to do the work in conjunction with a data
collection center; which would
allow for some training. Dr. Evans said that they have not decided how
to measure insulin, and will take his
recommendations under consideration.
Ms. Holloran agreed with Dr. Kail that there are other things NCCAM
could do. This appears to be a
study from the conventional medicine point of view. She wondered if it
would be possible to study the
at-risk population that is not being treated, to see what chromium does
for them. Dr. Evans said they will
consider that.
Dr. Cantwell thought the project was very reductionistic. He would prefer
that they examine something like
supplements, rather than just look at chromium. Brewers yeast might be
better, for example. He agreed
with Dr. Kail, that this would be more appropriate for other institutes
to fund. Dr. Straus told them that the
NIDDK would be interested in partnering on such a study, but would not
fund it alone. The best design
would come from investigators in their applications. He added that a study
of multiple supplements could
become extraordinarily complicated, and there is no ethical way to withhold
insulin from those who need it.
Dr. Kail asked if they could develop step-wise protocols in which they
keep adding agents. Dr. Straus
would like to know how chromium works as a step added to conventional
medicine. Dr. Kail suggested
that a next step might be to add vanadium. Dr. Meeker asked why this is
considered a CAM therapy. It
struck him as more conventional. Dr. Nahin explained that by the NIH taxonomy,
this therapy is not
conventional. He added that all institutes have different definitions
of what they do and what they do not
do. Dr. Meeker remained concerned that this was not appropriate for NCCAM.
Dr. Straus reminded the Council members that they were allowed to reject
concepts. He added that
Congress has demanded a substantial rise in diabetes research, and that
NIDDK has asked for an
NIH-wide effort. This concept responds to Congress and NIDDK. Dr. Nahin
added that not every
concept that is cleared will actually be funded, because funds are limited.
They wanted to get this concept
in the pipeline for when the money is available. Dr. Lawrence noted that
the concept also addressed the
health disparities issue, which was a reason to approve it. As a chiropractor,
he felt that Dr. Kail’s
argument would preclude research into chiropracty, because it might not
be viewed as broad enough. The
chromium project would not be a limited study of chromium, but it would
be a study of chromium in
relation to something else. Dr. Grimm stated that he did not believe they
could do a project the way Dr.
Cantwell proposed, because it would be too big. This project could save
people from harm by studying to
see what chromium really does.
Dr. Kail offered a compromise. He said that while this work needs to
be done, NCCAM should not give
the message that they study single agents. He proposed studying the way
in which treatment is done, rather
than just chromium as a single agent. Dr. Standish felt that NCCAM should
make a contribution to
diabetes research in some kind of concept clearance, while making extreme
efforts to work with other
institutions on such studies. She suggested a parallel concept or Request
for Application (RFA) to contrast
how Chinese medicine looks at diabetes. Dr. Meeker wondered if they were
picking up definitions of
CAM from other agencies, which would make NCCAM a clean-up operation,
something he disliked. Dr.
Straus noted that each institute defines its own mission and work. His
concern was that some research
might fall through the cracks. He was also concerned that the public would
chastise them if they allowed
important needs to go unmet. He added that co-funding in an area of joint
interest discounts the cost. Dr.
Kaptchuk stated that many important single agents fall under the category
of CAM, such as St. John’s
wort. The reason this particular concept was problematic was that there
was the perception of NCCAM
as "a dumping ground." But his belief was that the most important
issue was useful treatments that were
dispossessed in conventional health care, so if they are to take orphans
from other institutes, they should do it.
Dr. Nahin noted that the $10 million dollar estimate was very much a
ballpark figure, and would have to be
adjusted later.
Dr. Straus asked for a vote, adding that NCCAM staff welcomed written
comments on proposals. The
first vote was for approval of the concept as originally written. There
were five votes in favor, four against,
and four abstentions. Because there was no majority, the concept as written
would not be funded. A
second vote was taken for approval of the concept with the understanding
that staff would seek
co-funding. This vote was 12 to 1, which meant that it passed with the amendment.
The second concept presented for clearance was EDTA Chelation Therapy
for Coronary Artery
Disease, presented by Dr. Christine Goertz. Chelation therapy is popular
among the public; a
conservative estimate is that in 1997, there were 800,000 visits for chelation
therapy in the United States,
despite the fact that it has not been studied. The concept was for RCTs
to strengthen the knowledge base
regarding the efficacy and safety of this treatment.
Dr. Kail noted that this concept was for an entire protocol, which he
liked. Dr. Grimm agreed that it was a
good topic, with a relatively low budget. Dr. Kaptchuk noted that they
could find the equivalent of the
placebo effect at work here, but both could be more beneficial than conventional
therapies. Dr. Nahin
added that they expect a long trial of four to five years and $10 to $15
million total. The vote was 11 in
favor, none opposed, and two abstentions, so the concept passed for funding.
Dr. Neal West presented a project concept to study botanical/drug interactions.
A number of studies
have shown that botanicals have an impact on the efficacy of conventional
medications, some detrimental
and some beneficial. This study would aim to prevent adverse interactions,
to establish possible synergistic
combinations, and to increase the knowledge base regarding the mechanisms
of action of botanicals. Dr.
Kail noted that although the proposal had merit, a possible stumbling
block would be the lack of
standardized products on the market. Dr. West agreed that there may be
a need to do some purification
before mixing and matching treatments. General Council opinion was that
the study should start with actual
marketplace botanicals. Standardization was also an issue in studying
botanical/botanical interactions,
which would be beyond the scope of this study. Dr. Leila Saldanha, in
the audience, stated that the industry
is trying to standardize compounds. The vote was unanimous in favor of
moving forward with the concept.
Dr. Nahin and Dr. Mary Ann Richardson of NCCAM presented the proposal
to study magnesium to
treat asthma. Dr. Nahin noted that asthma is associated with more severe
outcomes in minority
populations. He presented data supporting the use of intravenous magnesium
to treat severe acute asthma.
Although there is one recent study which examined the use of dietary magnesium
to control mild to
moderate asthma, the most compelling data are from studies of intravenous
magnesium use in emergency
room settings. Dr. Nahin noted that the previous studies were straightforward,
with the primary outcome
usually being some measure of bronchiodilation. Subjects for these studies
were often limited to those
patients in whom standard treatment had failed. Dr. Nahin added that when
this therapy works, it appears
to work right away. Given Council’s reaction to the concept clearance
for chromium to manage diabetes,
Dr. Nahin asked the Council if the current concept fell within their definition
of CAM.
Dr. Cantwell observed that oral studies lacked data, but it should be
easy to recruit for the intravenous trial
and the outcome would be straightforward. He stated that it would be easy
to measure flows and the rate
of hospitalization. He saw the study as requiring only 1 year, while addressing
the health disparity issue.
Grimm stated his lack of enthusiasm for this study, for which he did not
see the necessity.
Dr. Kaptchuk expressed his opinion that there is a difference between
CAM and what he called "the
abused children of conventional medicine." He was concerned about
NCCAM investing in too many
orphans that other institutions have abandoned. At the least, these studies
should be co-funded. Dr. Nahin
said that the NCCAM staff would pursue co-funding with other NIH Institutes.
Dr. Kail added that this
study would be a rescue of a failed conventional treatment. Dr. Grimm
said that while he was being
convinced of the need for this study, an important aspect would be the
control group, so it would be
important to focus on "blinding," since hospitals could create
a bias.
A vote was taken, with 10 in favor, one opposed, and two abstaining.
Dr. Straus assured the Council that
they would continue seeking partners. Ms. Holloran asked to have the Council
on record as wanting
co-funding. Dr. Straus agreed that this was a good idea, but noted that
such a vote would not affect the
actions of other institutions within NIH.
Dr. Nahin introduced Dr. Kim Phan, a representative from the National
Cancer Institutes. Together they
presented the final concept for clearance, which dealt with expanding
CAM research at NCI cancer
centers. NCI has asked NCCAM to partner on research of CAM therapies in
treating cancer, cancer
symptoms, and side effects of conventional cancer therapy. There would
be a training component in this
project, geared specifically at getting CAM practitioners into these large
cancer centers, while growing the
interest of the centers in CAM so that their researchers would continue
to work in this area. Dr. Kahn liked
the idea of cross-pollination and wondered if there would be a way to
follow up on this aspect of the
project. Dr. Nahin assured her that there would be.
Dr. Phan stated that applicants would be evaluated on their commitment,
the space made available, and the
matching funding, which could triple the funds dedicated to the proposed
activities. NCI has 38 funded
cancer centers through the cancer center support grant (P30). Dr. Cantwell
observed that most cancer
patients use both conventional and CAM therapies. Dr. Nahin added that
cancer researchers want to
examine botanicals in conjunction with conventional medication. There
is also interest in Chinese traditional medicine.
The vote on proceeding with this concept was unanimous (13).
Dr. Straus noted that Council had worked on enough concepts to get a
feel for what was involved in them.
He suggested they rank the ones they had approved, so that they could
get a sense of where they had been
and so that NCCAM staff could develop a sense of Council priorities and
interests. Dr. Nahin noted that
this exercise would provide them with a sense of where to go in future,
since they will be evaluating four or
five concepts at every meeting for next couple of years. Since funding
cannot cover them all, this would
also help staff to decide which concepts to release in which order. Dr.
Straus added that, over the last
year, staff has been presenting concepts in the order of most perceived
urgency. Dr. Straus then asked
Council to rank the five concepts they evaluated that day.
The evaluation process showed that the first priority was the concept
to expand CAM research at NCI
cancer centers. Next was the EDTA chelation study; the drug interaction
study was third, and the
magnesium and chromium studies were last.
Ms. Holloran asked that the NCCAM staff develop a concept for clearance
in the area of hormone
replacement therapy for women going through the menopause. The concept
would look at CAM
alternatives in terms of safety and efficacy. Council decided that members
with concept proposals should
submit them during the coming months, to be reviewed by NCCAM prior to
the next meeting.
The meeting adjourned at 5:15 p.m.
DAY TWO - MAY 9, 2000
IX. Call to Order
At 8:30 a.m. on January 25, 2000, Dr. Nahin called the meeting to order.
X. Review of Applications
The session was closed for peer-review of applications. A total of 85
applications were assigned to
NCCAM. Of these, 53 were reviewed by NCCAM with the rest reviewed by the
Center for Scientific
Review. Applications that were noncompetitive, unscored, or were not recommended
for further
consideration by the initial review groups were not considered by Council.
Council reviewed 36
applications requesting $ 13,657,543 in total costs. Council concurred
with the initial review of 31 new
research grant applications for a total cost of $12,814,864.
XI. Adjournment
There being no further business, the meeting was adjourned at noon on
Tuesday, May 9,
We hereby certify that, to the best of our knowledge, the foregoing minutes
are accurate and complete.
Executive Secretary,
National Advisory Council for Complementary and Alternative Medicine
Chair,
National Advisory Council for Complementary and Alternative Medicine
Members absent themselves from the meeting
when Council discussed applications from their own institutions or when
a conflict of interest might occur. The procedure applies only to individual
applications discussed, not to en bloc actions.