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Minutes of the Third Meeting - May 8-9, 2000

National Advisory Council for Complementary and Alternative Medicine (NACCAM)

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NACCAM Members Present
NACCAM Member Absent
NIH Staff Members Present
	I.	Call to Order and Meeting Procedures
	II.	Introduction of Members
	III.	Future Meeting Dates
	IV.	Review of Confidentiality and Conflict of Interest
	V.	Director's Report and Overview of Draft Strategic Plan
	VI.	Development of a Trans-NIH Health Disparities Agenda
	VII.	Public Comment
	VIII.	Proposed Program Initiatives
	IX.	Call to Order
	X.	Review of Applications
	XI.	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.

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