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Minutes of the Fifth Meeting - November 13, 2000

National Advisory Council for Complementary and Alternative Medicine (NACCAM)

On this page

On this page:

  1. Call to Order, Introductory Remarks, and Meeting Procedures
  2. Future Meeting Dates
  3. Minutes
  4. Review of Confidentiality and Conflict of Interest
  5. Director's Comments
  6. Proposed Program Initiatives
  7. View from Another NIH Institute
  8. Public Comment
  9. Review of Applications
  10. Adjournment

The National Advisory Council For Complementary and Alternative Medicine (NACCAM) convened at 8:30 a.m. on November 13, 2000 at the Neuroscience Office Building in Rockville, Maryland. Richard Nahin, MPH, Ph.D., Executive Secretary, called the meeting to order. The meeting was closed to the public on November 13 from 1:00 p.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. Michael Cantwell
  • Dr. Haile T. Debas*
  • Ms. Susan Holloran
  • Dr. Janet Kahn
  • Dr. Konrad Kail
  • Dr. Ted Kaptchuk
  • Dr. Dana Lawrence
  • Ms. Diana Manley
  • Dr. William Meeker*
  • Dr. Anna McIntosh*
  • Dr. Everett R. Rhoades
  • Dr. Marilyn J. Schlitz*
  • Dr. Leanna Standish*
  • Mr. James E. Williams, Jr.

*via speakerphone

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NACCAM Members Absent

  • Dr. Richard Grimm
  • Dr. Karen Olness
  • Dr. Herbert Pardes

NIH Staff Members Present

  • Dr. Sheryl Brining, NCCAM
  • Dr. John Chah, NCCAM
  • Ms. Linda Engel, NCCAM
  • Ms. Marguerite Evans, NCCAM
  • Ms. Carol Fitzpatrick, NCCAM
  • Dr. Christine Goertz, NCCAM
  • Ms. Anita Greene, NCCAM
  • Dr. Eugene Hayunga, NCCAM
  • Dr. Richard Hodes, NIA
  • Ms. Christine Hollingsworth, NCCAM
  • Ms. Camille Hoover, NCCAM
  • Mr. Doug Hussey, NCCAM
  • Dr. Morgan Jackson, NCCAM
  • Ms. Kathleen Madden, NCCAM
  • Dr. Richard Nahin, NCCAM
  • Dr. Mary Ann Richardson, NCCAM
  • Mr. Charles Sabatos, NCCAM
  • Dr. Stephen Straus, NCCAM
  • Ms. Shirley Villone, NCCAM
  • Dr. Neal West, NCCAM
  • Dr. Jeffrey White, NCI

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I. Call to Order, Introductory Remarks, and Meeting Procedures

Richard Nahin, Ph.D., MPH, Executive Secretary, NCCAM, opened the meeting by noting that there would be enough members for a quorum, and that Drs. Standish, Debas, and Schlitz would take part via speakerphone. Continuing the practice of having other institute directors from the National Institutes of Health (NIH) speak to NCCAM, Richard Hodes, M.D., Director of the National Institute on Aging (NIA), was on the agenda to discuss NIA's activities in complementary and alternative medicine (CAM). There would also be an opportunity for public comment. Today's meeting would have both an open and a closed session. Law 92-409 requires that federal advisory panel meetings be open to the public. The closed portion was to be held in accordance with the provisions of Section 552b(c)(4) and 552b(c)(6), Title 5, U.S.C. and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), so that the council could discuss, review, and evaluate applications. Dr. Nahin then asked the members to introduce themselves.

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II. Future Meeting Dates

The next council meeting will be February 5 and 6, 2001, in the Neuroscience Office Building. Subsequent meetings are scheduled for May 31 and June 1, 2001; August 27 and 28, 2001; January 28 and 29, 2002; May 27 and 28, 2002; and August 26 and 27, 2002. NCCAM will determine at a later date if a November 2001 meeting is necessary.

Council members received a folder with a number of items, including the minutes from the last meeting, information about some letters of appeal, and one of the summary statements.

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III. Minutes

Dr. Nahin reminded Council that he had e-mailed them a draft of the last meeting's minutes. He asked for any remaining comments by Council. Ms. Holloran had a question about a statement in the minutes attributed to her. Dr. Nahin said he would clarify the statement in the current minutes: Review of Council transcripts revealed that the statement in question was in response to a presentation by Linda Engel, Special Assistant to the NCCAM Director for Program Development, on the final NCCAM Strategic Plan. Ms. Engel stated that NCCAM had not received any comments on the definition of CAM that was presented in the Plan. Ms. Holloran responded that it was a major step forward that there is a common understanding of the definition of CAM.

IV. Review of Confidentiality and Conflict of Interest

Dr. Nahin said that he would discuss confidentiality and conflict of interest at the beginning of the closed session.

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V. Director's Comments

Dr. Straus welcomed the council and briefly reviewed center activities. There have been major organizational changes and appointments within the Department of Health and Human Services (DHHS) and NIH that will affect NCCAM. The first of these was the creation of a new Office for Human Research Protection (OHRP) within DHHS, and the appointment of Greg Kosky, M.D. as the director. This new office has expanded authority over human subjects research than its predecessor, which was under NIH. Goals of the office include working with NIH and Food and Drug Administration (FDA) to carry out new patient protection initiatives. First among these is education and training of investigators and staff. It is increasingly important that clinical investigators have some baseline level of knowledge and experience with the federal regulations regarding human subjects. Training has begun at NIH, and Institutional Review Boards (IRBs) will have an expanded training function. In addition, there will be new guidance and procedures relating to informed consent, so that all human subjects are fully informed. The office hopes to improve the monitoring of researchers and sponsors to ensure safety and to detect problems quickly. Finally, there will be clarification of conflict of interest issues. The development of this new office will affect how clinical research is conducted in the United States.

Reynard Kington, M.D. has been appointed Director, NIH Office of Behavioral and Social Science Research. This office coordinates NIH research on mind/body medicine, and funds five mind/body centers across the country. Dr. Straus has talked with Dr. Kington on several occasions about shared interests. In another organizational development, both houses of Congress have approved establishment of a Center for Minority Health and Health Disparities at NIH. This Center evolved from the former Office of Research on Minority Health. The director of the office is now the designated director of the new center.

While there is still uncertainty regarding the Presidential election, both Governor Bush and Vice President Gore support the continued doubling of the NIH budget. In addition, there are important changes afoot in Congress. Of great significance is that there will be new chairs for both the House and Senate Appropriations Committees. Those stepping down Representative Porter and Senator Specter were strong advocates of NCCAM. As of November 13, NIH was funded under continuing resolution, which restricts operations to a percentage of the previous year's budget. It remained unclear whether and when an appropriations bill would be passed. The large growth in NCCAM's portfolio during Fiscal Year 2000 means that there are substantial out-year commitments for the next 2-3 years. Because of this, the final FY 2001 budget will determine NCCAM's capacity to fund new initiatives.

NCCAM continued recruiting new personnel aggressively, and recently hired a new Grants Management Officer, Ms. Victoria Putprush Carper. Interviews for the intramural program's Clinical Director have been completed, and a panel would soon review the applications for the Director, Office of International Health Research. NCCAM is also in the process of hiring more program officers. The ability to hire these people and expand the research platform requires that there not be a hiring freeze in government, which occasionally occurs with new administrations. Such a freeze would hurt NCCAM's progress tremendously. Leanna Standish, N.D., Ph.D., noted that the Council should be mindful of what they can do to help in any of these situations.

Dr. Debas asked for more explanation about the monitoring of researchers by OHRP. Dr. Straus explained that this is evolving, with changes in many areas. There has been an international dialogue about the use of placebos in research and whether it is ethical to withhold proven therapies in favor of placebos. NIH already requires external data safety and monitoring boards for clinical trials, which provide independent evaluation. The unresolved issue is how to encourage robust research while ensuring the greatest safety? Another issue under discussion is financial conflict of interest by NIH grantees. NIH researchers have always been held to stringent standards. The sense is that there should be a realistic appreciation of the fact that some of these scientists also hold patents and have proprietary interests. New regulations should not prohibit investigator ideas from flowing into the research pipeline. At the same time, there needs to be assurance that personal profit does not drive decisions, which should be made for the good of science and the subjects. Dr. Straus added that the changes enacted by OHRP will not prohibit research, but clarify possible conflicts of interest.

IRBs will likely need to have greater community representation in the future, and it is likely that all members of IRBs will have to go through training programs. There will probably be increased oversight of the IRB processes, and more auditing by OHRP and the FDA. This will affect NIH-funded research because of the increased costs of managing IRBs and the increased professionalization of IRBs. It will affect the funding of research.

IRBs do not review the science of clinical protocols; they consider the ethics. However, there are ethical issues if an IRB does not understand the therapies or how they are delivered. As such, new IRBs will require more community membership.

VI. Proposed Program Initiatives

The Council reviewed three concepts for clearance. The first, presented by Marguerite Evans, M.S., was entitled "Popular Diet Therapy for Obesity, Diabetes, and Coronary Heart Disease Risk Factors in Adults: Safety and Efficacy." The specific purpose is to study unconventional diets for obesity, diabetes, and cardiovascular disease risk factors. At present, little research verifies the effects of these diets. This initiative would increase the amount and quality of research evaluating the safety and efficacy of these diets in adults. There would be two types of studies: one would address safety and efficacy, and the other would examine methodology. The concept allowed the use of both R21 and R01 mechanisms.

Ms. Holloran asked for a clarification, as there seemed to be two purposes to this project concept methodologies, and development of more data. She suggested that developing methodology should come first. Ms. Evans replied that there are many types of diets, and while some have had no research, some have had a lot. For those with none, there may be a need to develop a methodology. Ms. Evans wanted to leave this project open for any diet, regardless of whether previous studies had been conducted.

Dr. Schlitz agreed that sometimes a test of methodology is part of a larger study, but she thought that this proposal pushed the limits of CAM. She wanted a definition of "an unconventional diet" and asked if a low fat diet is to be considered alternative medicine. Ms. Evans said that NCCAM's categorization of alternative treatments has listed "special diets" without a definition since the inception of the Office of Alternative Medicine (OAM). Therefore, she would leave the definition of an alternative diet to the investigators. An unproven diet that has not been endorsed by medical groups might qualify as CAM. Dr. Kahn also felt that this was an issue for clarification. She did not want NCCAM to become a place that did whatever research other NIH institutes do not want to fund. Dr. Kahn would prefer that this initiative look at diets emerging from a system of medicine, such as macrobiotic or Chinese medicine. To accept any unconventional diet for investigation seemed off the mark to her.

Dr. Kail said that he believed the intent of the proposal was to investigate diets with some basis in practice. Diets are seldom a single modality, as they are usually done with exercise and other activities aimed at achieving health goals. A diet must be used along with other components of lifestyle management. He felt that the proposed research would investigate a single agent versus a comprehensive approach, although he agreed that these diets do need to be investigated. Dr. Kahn asked if the emphasis would be on safety or on finding good treatments. Ms. Evans replied that there was no focus in that respect. Dr. Kaptchuk liked the concept, in that it responds to a real consumer issue. The public demand for diets is strong. The public believes in these diets, like they believe in CAM. Therefore, he saw the project as very related to CAM and felt that consumers have a right to have these kinds of interventions investigated on their behalf.

Dr. Schlitz noted that she liked the initiative, but she was unsure about its boundaries. She asked if there were a way to ensure it had a strong CAM aspect, rather than simply being a nutrition study. Ms. Evans replied that the investigators would need to provide evidence of prior use in their proposals. She was also thinking in terms of whole foods or combinations of foods, not supplements. Dr. Kail added that he favored the concept, but he would like it limited to looking at very popular diets with potential for danger or diets that have not been fully explored. Low fat diets have already been studied, and he would consider that duplicative. Ms. Evans agreed that programmatic relevance could be an element in evaluating applications. Ms. Holloran suggested that they tighten the concept to address Council concerns.

Dr. Kail said that he believed NCCAM has a responsibility to study this area, as other institutes will not. There is an obligation for someone to look at diets and apply science to them. Dr. Cantwell observed that in dietary research, trials are large and expensive; in order to undertake something of that scale, NCCAM would need to collaborate with another organization. Another concern, was that the concept was both too broad and too narrow. Dr. Cantwell liked the notion of investigating diets coming from CAM sources, but he thought the proposal was too restrictive by looking at only three diseases. Dr. Cantwell suggested opening the initiative to all diets originating from a CAM system or diets that no other organization will support. Mr. Williams agreed, noting that NCCAM is bound to be the watchdog for some popular therapies. Dr. Rhoades remained unpersuaded, but said that if the NCCAM staff can tease out a CAM-related topic having to do with diets, he might then go along with the concept.

Ms. Holloran was still concerned about inviting applicants to do a tremendous amount of work when NCCAM has not even defined what is wanted. She would prefer that NCCAM take the time to develop a narrow definition up front. Dr. Nahin explained that the full announcement is longer and much more explicit. It may contain input from co-sponsoring institutes. Moving from concept clearance to a solicitation for applications is a multi-month process. What has been done thus far is a small fraction of the total work. The sense of the council directs the future work on a concept. Dr. Kaptchuck was concerned that the highest scores would go to those applicants having the most preliminary data. He would like to restrict the RFA to R21s in order to encourage smaller applicants. He also felt that the larger NIH institutes should be picking up more of this work.

Dr. Kahn was still concerned that they might get some excellent proposals on diets without a strong CAM element, which would put NCCAM in the position of struggling to decide whether or not to accept the proposals despite their excellence. This is a situation she would like to avoid. Therefore, she felt a need to have a better definition of CAM. Dr. Nahin offered that staff could come back with a more refined definition of a "special diet." He then asked Council to vote on the initiative as presented, including the disease limitation, with the understanding that staff would clearly define "special diet" in the final RFA. Council would see this definition before the concept moved forward. He reminded the Council that they were not obligated to approve the concept, then called for a motion. There was some discussion as to what the motion really meant. Drs. Nahin and Straus both stated that the motion was to support the initiative as presented. If Council was not content with the current initiative, they should vote against the motion. A negative vote would signal to staff that they would have to substantially rework the initiative while considering Council's comments. With this clarification, the vote was taken. The motion was rejected by a split vote of Council, six to four.

Dr. Richardson presented the second project concept, titled Phase I/II Trials: CAM and Cancer. This initiative would facilitate the development and conduct of studies of promising CAM cancer treatments. Objectives are to conduct Phase I and II clinical trials to assess dosing, pharmacology, safety, and biological efficacy, which will in turn justify more definitive trials; support the characterization, standardization, and preparation necessary for IND development, as well as production of materials suitable for testing in NIH-sponsored trials; and to determine the pharmacodynamics, pharmacokinetics, and toxicology of these agents in animal and/or clinical studies. There will be two funding mechanisms: R21s for the smaller, early Phase I studies, and R01s for larger, more advanced studies. Funds could be used to support preclinical toxicology studies in animals. Proposed studies must have sufficient data from other sources to demonstrate potential efficacy, however. The studies must also address ethical considerations in using alternative treatment options and must justify use of these agents in the proposed patient population. NCCAM has been in contact with the National Cancer Institute (NCI) about a possible collaboration.

Dr. Cantwell said that he was assuming that energy medicine and qi gong would not be included in this project. Therefore, the project title should be refined to exclude these types of therapies, and the words "biological effect" should be added to the title. Dr. Standish asked how NCCAM staff developed the budget. Dr. Nahin said that staff was responding to the types of proposals they have been hearing about from investigators and practitioners who have been approaching NCCAM. In addition, the initiative should fill gaps in NCCAM's portfolio. For instance, NCCAM has yet to establish a bridging step to follow the Cancer Advisory Panel best case series; this initiative would fill that need.

Ms. Holloran said that she thought the budget was too low given the public's need from information on this topic. Dr. Richardson said that NCCAM was seeking additional support from other institutes, particularly the NCI. Dr. Schlitz moved to approve the concept. The vote on the motion was unanimous for approval.

The third project for concept clearance was entitled "Complex Botanical Interactions." Neal West, Ph.D., explained that many indigenous systems use multiple remedies involving complex botanicals. The underlying systems of belief hold that the polypharmacy of complex botanicals provides distinct advantages over single-ingredient drugs, but there is little research to support these beliefs. One underlying theoretical paradigm is that primary active ingredients in complex botanicals act synergistically with secondary compounds. A second paradigm is that secondary compounds mitigate the undesirable side effects caused by the predominant active ingredients. Another possibility is that the multiple ingredients act through multiple discrete pathways to therapeutically effect the host, and that lower concentrations of each of the botanicals can therefore be more efficacious when used together than when used individually. Studies are needed to demonstrate the mechanisms of action and to verify the efficacy. Studies can compare complexes versus single agents. The use of complex botanicals has historically been based on empirical observation. This concept will help determine which combinations are truly likely to be efficacious.

Dr. Cantwell pointed out that the public mixes treatments in eclectic ways. This project seems to study traditional systems and combinations, rather than the unsystematic mixing. Dr. West agreed, explaining that the thinking was that this project could address technology development. Dr. West was struck by the small number of published research papers in this area, even within communities that use these therapies. He had little success in finding information, so he felt comfortable in stating that this is a new area of research. Dr. Schlitz agreed that there has been little research in this area, and thought that innovative methodological development could be very helpful. Dr. Kail thought that the project would be very important, in that it reflects what happens in the field and what the public is getting. He felt that this is the first NCCAM concept to examine the complexity of botanical treatments. Dr. Cantwell asked if the use of Chinese herbs would be considered in the realm of this project. Dr. West said that it would. Dr. Cantwell also asked if INDs would be required. Dr. West replied that animal in vitro studies could proceed without INDs, but INDs might be required for human subjects research; the FDA would make that determination on an individual basis.

Dr. Straus noted that while INDs are often viewed as bureaucratic obstacles, they are easier to obtain than most people think, especially for very early phase studies. They are also easier to obtain for small studies than for larger trials. He suggested that INDs be viewed in a more favorable light. An IND should be seen as an important protection to human subjects. If some researchers find they cannot guarantee the required level of safety, the American public should not support the study. Dr. Kail motioned to adopt the project concept as written. The council voted unanimously to do so.

Next, Dr. Nahin led a discussion on how Council could best convey its ideas to NCCAM. He noted that five research topics suggested by Council Members are working their way through the NCCAM planning process. Dr. Schlitz noted that it might be convenient to send in suggestions via email. Ms. Holloran felt that Council needed more time to discuss their own objectives as a Council. She suggested that Council should remain two days in length, so that several hours each meeting could be used to discuss issues important to Council. Dr. Kahn added that she would prefer having the agenda ahead of time, with an opportunity to suggest additional items within a set time frame. Dr. Debas said that he liked the idea of having time for member discussion, but he did not like the idea of an open agenda. Dr. Rhoades observed that NCCAM is still a work in progress. He suggested a retreat for council members to discuss some of the important issues among themselves. Dr. Straus explained that council meetings must be announced in the Federal Register and must be open to the public unless specific criteria are met. Dr. Nahin added that even closed sessions must be announced in the Federal Register. Council members should not be meeting as Council outside of their official duties, although they could meet as individuals. Dr. Straus said that the council has a lot of work at each meeting, and the council mandate is to develop concepts, consider approaches, and provide advice on the prioritization of grants and contracts, which taken together is a large task. Within the confines of their time frame, the Council needs to work at maximum efficiency. Dr. Straus noted that most NIH Institutes have very focused one day meetings. Dr. Straus closed by noting that some day, the NCCAM portfolio may have to be broken into segments and reviewed by subcommittees as done at other NIH Institutes. Dr. Kail and Ms. Holloran both stressed that NCCAM has a different mandate and different issues then other NIH Institutes. Dr. Kail suggested that NCCAM should think outside the box. Ms. Holloran also emphasized that NACCAM should not get bogged down in procedural issued, but should concentrate on how Council relates to the work before it. She noted that NCCAM's particular mission may require that it not look or function exactly like the other NIH Institutes and Centers. Dr. Straus reiterated that NCCAM is interested in Council ideas and said that staff will seek Council input on future agendas. However, Council needed to remember that successful agendas focused on core issues for which there is broad appeal for discussion.

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VII. View from Another NIH Institute

Dr. Straus introduced Richard Hodes, M.D., Director of the National Institute on Aging (NIA). Dr. Hodes explained that NIA shares some characteristics with NCCAM, having a wide mandate beyond a specific disease or organ. Like NCCAM, NIA was established by Congress.

Dr. Hodes outlined the NIA mission, which is to support and conduct research on the aging process, age-related diseases, and the special problems and needs of the aged; train and develop research scientists; provide research resources; and disseminate information on health and research advances. Among its many research activities, NIA has a number that relate to CAM.

Currently, NIA is collaborating with NCCAM on a clinical trial investigating the role of ginkgo biloba in preventing or delaying dementia in older adults. NIA also has behavioral studies that are looking at patient/provider relationships; religion, aging, and health; and medication use and outcomes. Basic research involving animals are studying the effects of soybeans on bone and reproductive tissue. NIA is a member of the NIH end-of-life interest group.

In a longitudinal health and retirement study, NIA has tracked respondent use of certain CAM therapies, including alternative services, diet supplements, prayer, and meditation. Another longitudinal study of perimenopausal women has gathered information about respondent use of nutritional remedies, herbal remedies, psychological methods, physical methods, and folk remedies, comparing the prevalence of these methods among various ethnic groups while also relating them to symptoms.

Finally, NIA supports CAM-related intervention studies. One of these compares phytoestrogens to progestrogens, with another examining the effects of Tai Chi on VZV immunity.

Dr. Kail asked if there is an effort to look at organ dysfunction in menopause. Dr. Hodes explained that the challenge of discovering the differences between normal aging and the disease process has been quite difficult. For example, loss of cognitive function as experienced with Alzheimer's disease was presumed to accompany normal aging as recently as the 1970s. Now this is understood to be distinct from normal aging. The question remains as to what non-disease changes the "normal" group experiences. The reasons for these changes are unclear, but NIA's research will help create interventions for those changes.

Dr. Straus asked Dr. Hodes to comment on other CAM issues of aging, such as the use of hormonal supplements. Dr. Hodes explained that it is clear that there is a striking decrease in hormone production with age, and these changes are not limited to those of menopause. The question arises as to whether these decreases contribute to adverse conditions and if so, how they should be addressed. Even after decades of studying hormone replacement therapy, for example, much remains unknown. There are also questions about risks. Dr. Straus noted that one of the reasons he invited Dr. Hodes to speak was to highlight that sister institutes have great depth and expertise in other areas, yet still grapple with many of the same issues as NCCAM.

Dr. Kail said that he would like to see a study that looked at hormone replacement versus hormone stimulation. Dr. Hodes agreed that this is an important issue. One question is whether the target of the intervention should be to restore youthful body levels. There is much to be done here and a large number of permutations. Dr. Cantwell said that it is difficult to get normative data about digestive function, an area in which naturopathic medicine often does interventions. He has only seen small studies and would like to see normative data. Dr. Hodes agreed that this was not studied enough. Dr. Nahin asked if NIA is following up on the health and retirement survey. Dr. Hodes noted that this has not yet been decided. Longitudinal data are more useful than cross-sectional in this context. Dr. Straus added that NCCAM is co-funding those studies. Dr. Cantwell observed that the intervention with the greatest reported use in the survey is prayer. He would like to see NCCAM and NIA partner in the area of spirituality, and he applauded NIA's efforts in that area. Dr. Hodes added that one important limitation is the development of measures of what ought to be monitored. Dr. Straus thanked Dr. Hodes for coming and said that the two centers will continue the dialogue.

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VIII. Public Comment

The NCCAM held a session for public comment. Kathy Fomous, Ph.D., spoke on behalf of her organization, the Council for Responsible Nutrition, which represents manufacturers of supplements. She commended NCCAM for its broad research agenda and Dr. West for the initiatives targeting botanicals. These studies reflect what the public is using. Ephedra in particular needs to be addressed. Consumers take three billion doses of this supplement each year. A Harvard study showed an acceptable risk and good weight loss results from ephedra. Her organization would like to see an NIH consensus conference on ephedra, and would like NCCAM to include industry in the process.

Dr. Kail asked if the NCCAM portfolio had any initiative pending on ephedra. Dr. Nahin replied that research on ephedra could be submitted under the botanical-drug interaction RFA or as an investigator-initiated grant application. Dr. Straus added that discussions have been held with the Office of Dietary Supplements (ODS) and some other concerned parties, including industry. They are putting together a colloquium. Ephedra is a very difficult issue. Weight loss is not a traditional target for ephedra treatment, but is a huge contemporary use by the American public. It is important to consider meaningful study designs. The main concern is the long-term safety and efficacy of the supplement. Ms. Holloran asked if there had been a definitive literature review on ephedra. Dr. Straus said that ODS has been considering such a review. Dr. Fomous added that her association contracted with an independent risk assessment organization in Canada, which did an extensive literature search. The final draft should be ready this winter. Once released, they will share it with ODS, NCCAM, or other NIH institutes. Dr. Straus noted that in these reviews, it is important to have experienced impartial scientists. Private parties doing reviews are not always as impartial. The question also arises as to how to study public health aspects. Dr. Kail said that the ephedra question raises the issue of how to study toxic botanicals in general. Dr. Straus closed by saying he looks to the Council for guidance on issues like this.

The public session of the meeting ended, and the closed session began once the room was cleared of unauthorized individuals.

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IX. Review of Applications

The closed session began at 2:00 p.m. A total of 120 applications were assigned to NCCAM. Of these, 86 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 74 applications requesting $ 49,891,981 in total costs. Council concurred with 74 new research grant applications for a total cost of $49,891,981; five of these were deemed as having high program relevance.

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X. Adjournment

There being no further business, the meeting was adjourned at 5:00 p.m.

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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