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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:

  1. Call to Order and Meeting Procedures
  2. Introduction of Members
  3. Future Meeting Dates
  4. Review of Confidentiality and Conflict of Interest
  5. Director’s Report and Overview of Draft Strategic Plan
  6. Development of a Trans-NIH Health Disparities Agenda
  7. Public Comment
  8. Proposed Program Initiatives
  9. Call to Order
  10. Review of Applications
  11. 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.

Top

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.

Top

NACCAM Members Absent

  • Ms. Mary Chung
  • Dr. Herbert Pardes
  • Dr. Gilbert Ramirez

Top

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

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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.

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II. Introduction of Members

Council members introduced themselves and stated their areas of expertise.

Top

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.

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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.

Top

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.

Top

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.

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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.

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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

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IX. Call to Order

At 8:30 a.m. on January 25, 2000, Dr. Nahin called the meeting to order.

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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.

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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.

Richard L. Nahin, M.P.H., Ph.D.
Executive Secretary,
National Advisory Council for Complementary and Alternative Medicine
Stephen E. Straus, M.D.
Chair,
National Advisory Council for Complementary and Alternative Medicine


1.

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.

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