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Minutes of the First Meeting - August 31-September 1, 1999

National Advisory Council for Complementary and Alternative Medicine (NACCAM)

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Council Members Present
Council Member Absent
NIH Staff Members Present
	I.	Call to Order and Meeting Procedures
	II.	Introduction of Council Members
	III.	Upcoming Meetings
	IV.	Review of Confidentiality and Conflict of Interest
	V.	Director's Report - Presentation by Dr. William Harlan, Acting Director
	VI.	Proposed Initiatives
	VII.	Review of Applications
	VIII.	Call to Order
	IX.	Proposed Initiatives - Continued
	X.	Subcommittees
	XI	Public Comments
	XII.	Statement of Understanding
	XIII.	Adjournment

The National Advisory Council for Complementary and Alternative Medicine (NACCAM) convened its first meeting at 8:30 a.m. on August 31, 1999 at the DoubleTree Hotel in Rockville, Maryland. The meeting was open to the public from 8:30 a.m. until 1 p.m. on August 31. The meeting was closed to the public on August 31 from 1 p.m. until 7 p.m. 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. The meeting was reopened on September 1 from 8:30 a.m., until 1 p.m. William Harlan, M.D., Acting Director, National Center for Complementary and Alternative Medicine, presided.

Council Members Present ⁽¹⁾

Dr. Michael Cantwell
Mary Chung
Dr. Richard Grimm
Susan Holloran
Dr. Janet Kahn
Dr. Konrad Kail
Dr. Ted Kaptchuk
Dr. Dana Lawrence
Diana Manley
Dr. William Meeker
Dr. Karen N. Olness
Dr. Herbert Pardes
Dr. Gilbert Ramirez
Dr. Everett Rhoades
Dr. Leanna Standish
James E. Williams, Jr.

Council Members Absent

Dr. Herbert Pardes
Dr. Marilyn Schlitz

NIH Staff Members

Dr. John Chah, NCCAM
William Darby, NCCAM
Marguerite Evans, M.S., R.D., NCCAM
Anita Greene, M.S., NCCAM
Dr. William Harlan, Acting Director, NCCAM
Dr. Eugene Hayunga, NCCAM
Doug Hussey, NCCAM
Steve LeBlanc, NCCAM
Dr. Richard Nahin, NCCAM
Chuck Sabatos, NCCAM
Dr. Neal West, NCCAM
Dr. Jeffrey White, NCI
Suzanne White, NHLBI
Patrick Williams, NIH OD

DAY ONE - AUGUST 31, 1999

I. Call to Order and Meeting Procedures

Richard Nahin, M.P.H., Ph.D., Executive Secretary NACCAM, called the meeting to order at 8:30 a.m. Dr. Nahin discussed the procedures by which NACCAM council members must abide and specifically addressed the requirements of working under Federal laws regarding open and closed sessions. The morning session of August 31 was to be open to the public, while the closed session, during which individual grant applications would be reviewed, was to be closed and the material discussed was to be kept confidential.

Dr. Nahin then gave a brief overview of the meeting's agenda, and outlined the basic items to be discussed August 31: the director's report and initiatives for the forthcoming fiscal year. The September 1 session would be devoted to further discussion of the initiatives, along with the organization and appointment of members to NACCAM's four subcommittees: training; CAPCAM; information dissemination; and centers.

II. Introduction of Council Members

Council members introduced themselves and stated their areas of expertise.

III. Upcoming Meetings

Dr. Nahin instructed members to view the list of upcoming Council meetings, which he said were planned two years in advance and therefore could not be changed. He urged members to make those dates.

IV. Review of Confidentiality and Conflict of Interest

Dr. Nahin reviewed conflict of interest and confidentiality requirements. 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; or (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, Dr. Nahin said, the NACCAM member was to withdraw from the discussion to prevent the proceedings from having an appearance of bias. Reviewers would be asked to sign a no-conflict statement after the reviews were completed. Dr. Nahin also instructed members 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 applicants contact reviewers, the reviewers should refer them to Dr. Nahin or William Harlan, M.D., Acting Director, NCCAM. Furthermore, Council members must not keep any materials distributed in a closed session. These materials must be returned to NCCAM staff since they contain confidential information.

The Council is was required to comply with Freedom of Information Act (FOIA) rules that govern disclosure of NACCAM work to the public and set guidelines for which meetings should be open to the public. The Council is required to consider Privacy Act issues. Third parties may receive approved applications under FOIA, but they may not receive rejected applications under the Privacy Act. Principal investigators may seek information within limits. Questions should be referred to Dr. Nahin or Dr. Harlan.

V. Director's Report - Presentation by Dr. William Harlan, Acting Director

Dr. Harlan, Acting Director, made his presentation to the Council. It had been a very busy year for all of the staff, and he complimented them on the outstanding job they had done in transitioning from being the Office of Alternative Medicine (OAM) to becoming the NCCAM.

History of OAM
Dr. Harlan reviewed the period of 1992-1998, before the organization became a center. OAM carried an annual budget that grew from $2 million at its inception to $20 million by 1998. A centers program had developmental centers in 14 areas; each center was budgeted at approximately $300,000 direct costs per year. Emphasis was on small projects that served as pilots for larger studies; training that combined complementary and alternative medicine (CAM) with conventional lab and clinical techniques; dialogue with non-academic CAM practitioners and the academic community; informational databases and education; and recruiting interest and involvement in CAM. Dr. Harlan noted that both the public and traditional medical practitioners had shown tremendous interest in CAM.

The OAM also cofunded training and research grants with NIH ICs (institutes and centers). The opportunity for cofunding allowed the OAM to leverage a small amount of money across many research projects.
1. Systematic Reviews
  The OAM also supports systematic reviews, and has an interagency agreement with the Agency for Health Care Policy and Research (AHCPR) to carry out three such reviews through the AHCPR Evidence-based Practice Centers program. The Cochrane Group, an international organization that does systematic review of clinical trials, is also involved in reviews of CAM. The OAM and the Centers conducted Field studies of CAM practices for Disease Control and Prevention (CDC) through an interagency agreement. Results will be reported soon.
  
  There is an also an agreement with the National Cancer Institute (NCI) to do a population survey of cancer patients and their interest in and use of CAM. The first report will may be out in September 1999. Preliminary evidence suggests widespread use of CAM therapies by cancer patients.
  
  Dr. Harlan stated the Practice-based Outcomes and Evaluation System (POMES) meeting in the summer of 1997 brought together CAM practitioners and conventional oncologists; this early discussion built trust, which led to the subsequent creation of the Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM).
2. Large Clinical Trials
  Dr. Harlan noted that OAM also supported large clinical trials, including one on the use of St. John's Wort to treat depression. This study was solicited by an RFA cosponsored with the National Institutes for Mental Health (NIMH). The trial, which is still underway, compares the effectiveness of St. John's Wort to both traditional medicine's use of selective serotonin re-uptake inhibitor agents, which inhibit the uptake of the neurotransmitter, serotonin, and a placebo. Previous to the trial, a systematic review of St. John's Wort and depression was published in the British Medical Journal. This systematic review convinced the OAM and NIMH to develop the RFA.
3. Informational Systems
  The OAM set in place informational systems, including a bibliographic database and a public clearinghouse.
Establishment of the National Center for Complementary and Alternative Medicine
The NCCAM was established in February, 1999, and assumed review, award, and project management for most grants and contracts that had already been worked collaboratively with the other ICs. One exception was the St. John's Wort study, which continues under the general management of the NIMH. These assumed responsibilities include RFA/RFP planning and announcements in fall 1998 and winter 1999, and awards for Fiscal Year (FY) 1999 and FY 2000. The NCCAM also collaborates with other ICs.
White House Commission On CAM (Established Concurrently)
The legislative language establishing the Center also established the Commission, which would look into issues not traditionally examined by the National Institutes of Health. These include the training and the certification of CAM practitioners, and stronger engagement of private sector in research. The budget and logistical support is provided by the NCCAM. The Department of Health and Human Services will make appointments to and oversee the Commission.
The Budget
The budget for FY 99 is $48.9 million and provides for a carryover through FY 2001. The general activities of the NCCAM are the same as NIH's 25 other ICs. These include having an advisory council; awarding grants and contracts; overseeing projects, programs, and performances; arranging reviews; requesting funds in accord with the NIH budget request; and conducting inter- institutes and centers or inter-agency collaboration.
Building an Evidence Base for CAM
Dr. Harlan noted that much of the information used as an evidence base for CAM is from case studies by CAM practitioners, ranging from manual manipulation to spirituality to use of herbs. CAPCAM is a federally chartered committee that meets at least twice a year and works in close collaboration with the NCI. The CAPCAM looks at experiences that practitioners have had, organizes that set of experiences, reviews information, and decides what direction should be taken next. It does not make grants or fund project, but instead provides technical assistance and advice.

Dr. Harlan said that systematic reviews accomplish several things: they allow researchers to structure all information from various sources, as well as different outcomes, and give researchers the opportunity to make the best assessment based on that information. Over 90 percent of trials in the United Kingdom are preceded by systematic review. The trials must be large enough to determine what the reasonable effect would be in most people.

Dr. Harlan outlined program mechanisms for building an evidence base in CAM. They include: 1) large, often multisite, randomized, controlled trials (RCTs) solicited through NCCAM initiatives; 2) pilot studies, funded by investigator-initiated applications; 3) centers or program projects; 4) large observational studies, most efficiently done using established cohorts and surveys; 5) small controlled trials (centers, R-01, private sector); 6) characterization of products and approaches by P-50 botanical centers, CAM centers, and the private sector; and 7) individual observations.

Clinical trials now underway include investigation of St. John's Wort for depression, acupuncture for osteoarthritis, glucosamine and/or chondroitin sulfate for osteoarthritis, ginkgo biloba to prevent cognitive decline, shark cartilage for solid tumors, and the Gonzalez Regimen for pancreatic cancer.

Dr. Harlan said that he believed the large clinical trials were outstanding for a modest $50 million budget, and he expects to receive a similar amount plus a bit more next year, depending upon congressional action.

In discussions, Dr. Harlan noted that it is clear that people want more information on alternative therapies, and they want to see these therapies subjected to trials that are as rigorous as possible. Dr. Harlan did note that CAPCAM built a bridge between traditional and CAM medicine, but that the trust level in the cancer community was higher than in other areas of medicine.

Further discussion noted that there was a need for activity in the private sector. The question was asked whether there had been any evaluation of systematic review of the OAM process, and if so, what had been learned from it. Dr. Nahin said that the strategic planning initiative document addressed this; the document would be released pending the appointment of the new director.

Dr. Harlan added that over time he has seen a change of attitude in the scientific community, and that CAM investigators are now being sought.

Gilbert Ramirez, Dr.PH., suggested that the council revisit the issue of the strategic plan. Dr. Harlan explained that 2 1/2 years ago, the OAM began to develop a strategic plan that came into final form in November or December of 1998. It seemed inappropriate to release the report before the appointment of the new director.

Dr. Nahin said he had been asked by several Council members to define their roles in closed session peer review. Council members had each been assigned applications for which they would be the primary reviewers. They were to present strengths and weaknesses during the closed session. Council members may or may not make a recommendation. The are six possible recommendations for any given application were reviewed for the public's benefit.

VI. Proposed Initiatives

Dr. Nahin made a presentation on proposed initiatives for the coming year. He first reviewed the purpose of the NCCAM as defined by Congress: "The general purposes of the National Center for Complementary and Alternative Medicine (NCCAM) are the conduct and support of basic and applied research, research training, and other programs with respect to identifying, investigating, and validating complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems."

He then reviewed the budget history (starting as OAM) from 1993, when the budget was $2 million to 1998, when the budget was set at $48.9 million dollars. He mentioned CAM methods, which ranged from megavitamin and orthomolecular therapy to yoga, massage and neurobiofeedback, among other treatments.

Dr. Nahin noted that according to the NCCAM, the definition of CAM was: "Medical and health care practices that are not an integral part of conventional (Western) medicine." Based on its congressional mandate, NCCAM has developed four broad program areas: developmental grant programs, phase III trials, center grants, and training and career development for CAM practitioners. Training and career development was of great importance, because without a critical mass of investigators the field cannot move forward.

Three project concepts were presented to the Council for concept clearance. The Council was to consider four aspects of each concept presented: significance, relevance, direction, and practicality.

Project Concept Review: Traditional, Indigenous Systems of Medicine
Dr. Nahin presented the first proposed project, Traditional, Indigenous Systems of Medicine. The purpose of the initiative is to support developmental studies to establish the methodological feasibility and to strengthen the scientific rationale for conducting full-scale randomized clinical trials on the use of traditional, indigenous systems of medicine. These pilot trials should emphasize the development of appropriate study designs to investigate safety and efficacy. The objective is to increase the quality of clinical research evaluating the efficacy of traditional, indigenous systems of medicine for the treatment or prevention of disease and symptoms. Proposed studies must successfully incorporate creative and realistic solutions to difficult problems in clinical research for the disease or condition under study. Ultimately, the proposed project could identify and address difficult methodological and design issues particular to complex medical interventions, as well as allow for the development of contextually sensitive research more closely reflecting worldwide practice.

After Dr. Nahin's presentation, discussion focused on whether or not it is possible to review entire traditions of CAM using the scientific method that the West requires as a standard. For example, not all elements of alternative systems have corollaries (e.g., healing ceremonies, etc.) that lend themselves to placebo parallels that clinical research requires.

An example was given of the need for cooperation with those being studied. An NIH study at the National Heart, Lung, and Blood Institute is examining obesity prevention in Native American populations. One tribe and four academic institutions received awards, with a three to four year feasibility phase. This study is complex because it involves Anglo cultures, NIH culture, and tribal cultures. The key has been to work with, and listen to, communities and employ people from reservations. Researchers in this ongoing study trained Native Americans, who gathered qualitative data during the feasibility phase that was used to develop the intervention and measurement methodologies. All parties had to agree on this intervention.

Another discussion addressed the need for the NCCAM to do extensive literature reviews. It was suggested that, for example, it would be possible to do such a literature review of India's extensive research on that country's own medical system. It was noted that the University of Oregon submitted a literature review as part of its application for a large trial on the use of ginkgo biloba. It was further noted that some cultures believe their healing cannot work outside their culture or without their healers, making certain traditions difficult if not impossible to study.

There was also some interest in an initiative to evaluate Western-based whole systems, such as osteopathy, naturopathy, and other practices.

Several council members noted that when people migrate from one country to another, they take along only part of their system of medicine, or the system changes. For example, systems of medicine from Latin America do not always remain intact among those who migrate to this country. There was some interest in learning what is adapted and how it is used among immigrants. Other cultures mix their medicine with ours rather freely. Procedures migrate and change, and therefore transformation of cultures should be mentioned in any NCCAM initiatives. Nonetheless, a piecemeal review of other systems may lead to less-than-optimal piecemeal adoption of practices. This initiative to look at whole systems is therefore crucial, and principal investigators should, in their applications, be clear about where their research is leading. NCCAM must be careful to avoid funding "fishing expeditions."

Another concern was that of expected outcomes. One participant noted that Eastern medicine seeks balance, while Western medicine seeks outcomes. A project that examines outcomes only might lead researchers to overlook other efficacies, such as improved quality of life even where there is no cure or change in mortality. Nonetheless, the need exists to validate these systems in some kind of Western context.

In making comments prior to the vote on concept clearance, members of the panel recommended that transformation be considered as a variable, with focus on traditional practitioners. The vote was unanimous in favor of initiative.

The morning session adjourned at 11:45 a.m.

VII. Review of Applications

The afternoon closed session reopened at 1 p.m. A total of 72 applications were assigned to NCCAM. Of these, 15 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 53 applications requesting $ 49,752,287 in total costs. Council recommended 29 new research grant applications with a total cost of $ 18,078,385

The closed afternoon session was adjourned at 7:00 p.m.

DAY TWO - SEPTEMBER 1, 1999

VIII. Call to Order

NACCAM reconvened with an open session at 8:30 a.m. on September 1, 1999. Dr. Richard Nahin, Executive Secretary, called the meeting to order. Discussion resumed with presentation of a second proposed initiative.

IX. Proposed Initiatives - Continued

Project Concept Review: CAM Clinical Research Curriculum Award (K30)
Neal West, Ph.D., presented a proposed initiative to improve the quality of CAM clinical research by providing didactic courses in the fundamental skills needed for clinical research. The long-term goal is to produce clinical researchers who are knowledgeable about the complex issues associated with conducting sound clinical research and who are competitive in seeking research support. It would span a variety of fields of CAM research but include clinical research subjects such as biostatistics, bioethics, pharmacology and pharmacognosy, clinical trial design, observational study design, and Federal policies and regulations regarding research involving human subjects. Other advanced courses, such as outcomes research and pharmokinetics, may also be offered.

Dr. West said that the program announcement would provide five years of renewable support, with an annual total cost per program expected to be $200,000. That figure would also include eight percent targeted for indirect expenses. The program would have a three-year life span, and during that time, provide nine opportunities to apply. The program should be considered a tool to facilitate the development of clinical research.

During discussion, a question arose about the eligibility of institutions without a critical mass of investigators. It was suggested that such institutions would be unable to compete, since they did not have an established track record. The suggestion was made that such applicants form partnerships with institutions that had research departments in order to develop those programs. The concern was also expressed that the program would force focused programs to cover topics outside of their range. It was asked, as an example, if chiropractors would need to teach aromatherapy to qualify for this grant.

Dr. West replied that the curriculum should cover a variety of CAM research fields, and that he did envision that a consortium could come in to the program, as has happened with other K30 grants. As the program evolves, the NCCAM can amend definitions over time, and notify institutions to send in revised applications for the next round. As time goes by, schools will see what type of programs win the award, and will decide if that is something they wish to pursue.

It was also asked whether the concept was to train students or current practitioners. Dr. West replied that the training was for people who wanted to become clinical researchers, and students could get their own grants to cover merging CAM and non-CAM practices as a method of developing resources. While the grant would cover travel for participants to take courses at other institutions, it would not cover tuition at the parent institution. The program should be used to complemented other awards that support the student's stipend.

A long discussion among panelists followed about how stipends are necessary, because applying for other programs on top of applying for an NIH stipend is burdensome. The NIH position was that stipends, and advice on how to apply for them, are available separately.

One Council member asked if the program was limited to students. Dr. West answered that many of those who apply for the program will be faculty who see the need for clinical research. Another question was raised about the training of other CAM groups, such as massage therapists, who traditionally do not see themselves as part of a research team. Dr. West said NIH does have short- term training for students specializing in research, and that the panel should bear in mind that NIH does not support conventional medical students either.

After each member made a short statement, a vote was taken and the initiative was supported unanimously.

Project Concept Review: CAM Education Project Grant

A significant percentage of patients now undergoing conventional medical care are also concurrently receiving CAM treatment. Dr. West presented a proposed initiative for a new R25 CAM Education Project Grant, which would support medical, dental, and nursing schools as they incorporate CAM into their curriculum and continuing medical education (CME) courses. The grant will offer up to five years of renewable support, with an average total cost per award to be $200,000.

Dr. Kail recalled a survey on CAM courses taught in conventional medical schools; none of the 19 schools surveyed offered a credential at the end of the training, and none of the schools had a licensed CAM practitioner on staff. The student response, he said, was poor. Dr. West replied that the grant has a requirement that CAM practitioners should be on faculty. NCCAM staff developed the program initiative by looking at a similar NIH grant dealing with nutrition education. Allopathic schools will have to meet NCCAM criteria in order to be eligible for the NCCAM grant. The goal of the program is not to make traditional medical educators function as CAM practitioners; it is to help them understand and be comfortable with CAM practices.

In response to questions, Dr. West said that applicants will have to be specific about both the faculty and nature of the program as part of the process and that the curriculum can be web-based. Council members noted that there should be more and better communication between physicians of conventional medicine and CAM practitioners. Ignorance of CAM practices can be dangerous, and allopaths must be aware of possible interactions between therapies and what constitutes questionable practices.

After members each briefly gave their thoughts on the measure, the proposed initiative received unanimous approval.

X. Subcommittees

NACCAM has four subcommittees that address the following topics: information dissemination; CAPCAM; training; and centers. The Council had the task of assigning members to the subcommittees and setting their agendas for the next year. Dr. Nahin pointed out that it was required to have at least three members on each subcommittee, and that council members could volunteer for the subcommittees in which they were most interested. The subcommittees were to set goals to meet by the next meeting; their purpose is to analyze data and present information and recommendations to the entire council, which would make necessary decisions. Subcommittees can meet in open forum, by e-mail, and through open conference calls. By law, subcommittees must be as open as the full council, and all final documents must be made public, although working documents do not have to meet this requirement.

The first subcommittee to be discussed had to do with the CAM centers. Council members who volunteered for this subcommittee included Drs. Standish, Meeker, Cantwell, and Kahn; others may join later. It was decided that the agenda would address what is currently happening at the centers, and how research results are being presented. Dr. Nahin suggested that because center outcomes must eventually be presented to Congress, the subcommittee members should start thinking about this requirement now.

Members of the training subcommittee included Drs. Kail, Olness, Kaptchuk, Lawrence, and Grimm. This subcommittee will focus on the integration of various elements into the larger picture of CAM training. One of its goals is to develop a facilitated application procedure in which the NCCAM will present a decision tree, enabling institutions to determine which programs apply to which needs, thus making it easier for them to know which programs or combinations of programs they should apply for. While this is being done now on an ad hoc basis, the Council sees a need to formalize the process. Another issue is the development of a strategic plan that will encourage development of training. Members of the CAPCAM subcommittee will serve as liaisons to NACCAM. Dr. Kail has been serving in this function. Dr. Kail reported on the CAPCAM, which has been active already, with 12 members from various organizations. The CAPCAM is finding that the most effective CAM practitioners in cancer are in private practice rather than research, and thus most of them fall outside funding mechanisms. Some modalities are proving difficult to measure; researchers need to be creative, and practitioners should be highly involved in designing projects. A best-case protocol was developed so clinicians can fill out forms, which the CAPCAM assembles and evaluates. Practitioners can then present information for discussion and CAPCAM recommendations.

The CAPCAM has found problems in the research presented so far, including: no clear diagnosis in some cases; no objectivity; short follow-up time; missing data; and the possible effects of previous conventional therapy. For example, the CAPCAM examined 14 cases of cancer treated with homeopathy in India. Most cases had at least one of the problems listed above, but there were four cases in which patients clearly improved due to treatment. The CAPCAM has suggested a prospective follow-up study (with a minimum of 50 subjects) as the next research step, with NIH staff possibly visiting India to help develop a protocol. A second research project, regarding soy product use, had a small patient population and good results; the practice wants more guidance. The CAPCAM gave guidance to practitioners on how to meet clinical criteria when doing research.

Jeffrey White, M.D., of NCI, is coordinating activities with the homeopathic practitioners from India and is trying to identify research groups they can work with. Dr. White has already made good contacts in Bombay and is trying to find a similar situation in Calcutta. Dr. White is looking for MDs or RNs to track patients who visit the homeopathic clinic under consideration in India.

Dr. Kail noted that most on the panel are from conventional research institutions and were struck by the success of some CAM therapies, such as homeopathy. Additional NACCAM members who volunteered to join this subcommittee are Mr. Williams, Ms. Holloran and Drs. Ramirez, and Standish.

Members of the information dissemination subcommittee include Ms. Holloran, Ms. Chung, and Drs. Lawrence and Ramirez. In discussing possible topics, the state of the NCCAM web site came up. It was suggested that each council member have a friend try to find information about CAM via the NCCAM web site, as an exercise to evaluate the web site. Outreach efforts were also discussed; these included appearing at conventions; public presentations via known alternative providers; and programs, briefing books, or videos, organized by disease or condition, that are oriented to the public and go beyond fact sheets. In this discussion, the NCCAM was urged to develop a book, preferably online and downloadable, to give the public a starting point in finding CAM information. This publication must be made accessible in simple language and focus on what the public wants to know rather than what the NCCAM or the NIH thinks people should know. One of the subcommittee's goals is determining how to find out what members of the public want and how they want it. They were urged to keep in mind that not everyone has web access, and that regardless of how the information is presented, there is a strong need to ensure that it is current.

XI. Public Comments

The NACCAM set aside time for comments from members of the public. Three individuals spoke. The first, Dr. Sandra McLanahan of the University of Virginia Medical College, noted the need for more emphasis on prevention. She had two recommendations: first, for the NIH to focus more on clinical research rather than basic research and "test tubes"; and second, to include the public in NIH studies. She closed by stating that there is a need for a larger context in which to view health. The second speaker, Dr. Barbara Mayerman, asked that the NCCAM focus on a nondisease-oriented center. She stated that double-blind research traditions don't always work for nontraditional methodologies. She also expressed some frustration with finding CAM information on the NCCAM web site. She felt that this site should have more links for members of the public to expand their own searches for nontraditional answers to health questions; she said that the NCCAM should focus on disseminating practical information through its web site. The final speaker, Ms. Beth Clay, emphasized that NCCAM's core purpose should be to inventory, evaluate, and present CAM information to the public.

XII. Statement of Understanding

The committee also made revisions to its Statement of Understanding, which would be finalized at the next NCCAM meeting.

XIII. Adjournment

There being no further business, the meeting was adjourned at 1 p.m. on Wednesday, September 1, 1999. The next meeting is scheduled for January 24-25, 2000.

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.	William Harlan, 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.