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Minutes of the Thirteenth Meeting - January 27, 2003
National Advisory Council for Complementary and Alternative Medicine (NACCAM)
On this page:
- Closed Session
- Open Session/Approval of Prior Meeting Minutes
- Overview of Activities at the National Institute of Mental Health
- Annual State of the Center Report
- 2003 Report: Compliance with the NIH Policy on Inclusion Guidelines—Overview
- 2003 Report: Compliance with the NIH Policy on Inclusion Guidelines—NCCAM Report
- Council Operating Procedures
- Concept Clearances
- Public Comment Session
NACCAM Members Present
- Dr. Zang-Hee Cho, Irvine, CA
- Dr. Kristina Collins, McLean VA
- Dr. Mahlon DeLong, GA*
- Dr. Murray Goldstein, Washington, DC
- Dr. Richard H. Grimm, Jr., Minneapolis, MN
- Dr. Michael Irwin, Los Angeles, CA
- Dr. Janet Kahn, Burlington, VT
- Dr. Konrad Kail, Phoenix, AZ
- Dr. Ted Kaptchuk, Boston, MA
- Dr. Eric Lien, CA*
- Dr. William Meeker, Davenport, IA
- Dr. Joost Oppenheim, MD*
- Dr. Jesse Roth, NY*
- Dr. Barbara Timmerman, Tucson, AZ
- Col. James Williams (Ret), Camp Hill, PA
- Dr. Benjamin Yang, San Francisco, CA
*Ad hoc members
NACCAM Members Absent
- Dr. Haile T. Debas, San Francisco, CA
- Dr. Herbert Pardes, New York, NY
NIH Staff Present
National Center for Complementary and Alternative Medicine (NCCAM)
- Mr. Howard Baldwin
- Ms. Willer Batten
- Dr. Josh Berman
- Dr. Marc Blackman
- Mr. Brian Campbell
- Ms. Victoria Carper
- Mr. Steve Casady
- Dr. John Chah
- Dr. Margaret Chesney, Deputy Director
- Ms. Mimi Choi
- Ms. Alyssa Cotler
- Ms. Linda Engel
- Ms. Carol Fitzpatrick-Mulligan
- Dr. Christine Goertz
- Dr. Martin Goldrosen
- Ms. Anita Greene
- Ms. Carolyn Hodgkins
- Ms. Mary Jo Hoeksema
- Ms. Camille Hoover
- Dr. Morgan Jackson
- Dr. William Kachadorian
- Ms. Jenna Khan
- Dr. Jane Kinsel
- Mrs. Marguerite Klein
- Ms. Catherine Law
- Dr. Patrick Mansky
- Ms. Ilze Mohseni
- Dr. Richard Nahin
- Ms. Ellen O'Donnell
- Dr. Nancy Pearson
- Mr. Marc Pitts
- Dr. Carol Pontzer
- Ms. Linda Rich
- Ms. Andra Standberry
- Dr. Stephen Straus, Director
- Ms. Jennifer Sutton
- Ms. Jennifer Tisch
- Ms. Shirley Villone
- Ms. Dawn Wallerstedt
- Ms. Allison Wise
- Dr. Shan Wong
Other NIH Employees
- Dr. Heather Burns, National Cancer Institute (NCI)
- Dr. Thomas R. Insel, Director, National Institute of Mental Health (NIMH)
- Dr. Richard Nakamura, Deputy Director, NIMH
- Dr. Moo Park, National Institute on Drug Abuse
- Dr. Wendy Smith, NCI
- Dr. Christine Swanson, Office of Dietary Supplements
- Dr. Jeffrey White, NCI
Members of the Public
- Mr. Bryna Block
- Ms. Kysa Christie
- Dr. Steven Dentali
- Mrs. Melinna Giannini
- Mr. Anthony Kinyua
- Mr. Harold Madison
- Ms. Michel Marcoux
- Ms. Elizabeth McIntyre
- Ms. Synthia Laura Molina
- Ms. Nancy Moy
- Ms. Joan Ordman
- Ms. Georgia Persus
- Mr. Barry Schnetter
- Ms. Elizabeth Sheley
- Mr. William Spun
- Mr. Kurt Thurber
- Ms. Marissa Valeri
The National Advisory Council for Complementary and Alternative Medicine (NACCAM) convened at 8:30 a.m. on January 27, 2003, at the NIH Neuroscience Conference Center in Rockville, Maryland. Dr. Jane Kinsel, Executive Secretary, called the meeting to order.
The first portion of the meeting was closed to the public in accordance with the provisions set forth in 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).
A total of 145 applications were assigned to NCCAM. Of these, 86 were reviewed by NCCAM, 53 by Center for Scientific Review, and 6 by other institutes. Applications that were noncompetitive, unscored, or were not recommended for further consideration by the scientific review groups were not considered by Council. Council reviewed and did not recommend 1 application and concurred with 112 applications requesting $18,114,885 in total costs.
II. Open Session/Approval of Prior Meeting Minutes
The open session of the NACCAM convened at 12:30 p.m. Dr. Jane Kinsel, Executive Secretary, called the meeting to order and reviewed the agenda for the open session. The members voted unanimously to approve the minutes of the previous meeting on August 26, 2002.
III. Overview of Activities at the National Institute of Mental Health
Dr. Stephen Straus, Director of the National Center for Complementary and Alternative Medicine (NCCAM), introduced Dr. Thomas Insel, Director of the National Institute of Mental Health (NIMH).
Dr. Insel explained that the mission of NIMH is a public health mission: to reduce the burden of mental illness and behavioral disorders through research on the mind, the brain, and behavior. He discussed a number of areas that are important priorities for NIMH, including suicide, depression, and the increasing use of psychoactive medications without proper evaluation. Dr. Insel also noted the importance of these issues in light of data showing the tremendous economic, social, and personal costs of untreated mental illnesses such as depression and schizophrenia.
NIMH is the seventh largest Institute at NIH, with a budget in FY 2003 of $1.3 billion. Dr. Insel described highlights of the research the institute supports: over 4,000 research projects through three extramural divisions—Division of Neuroscience and Basic Behavioral Science; Division of Services and Intervention Research; and Division of Mental Disorders, Behavioral Research, and AIDS—and a Division of Intramural Research, as well as communications, education, and outreach efforts.
There is fragmentation of mental health care in the United States, and our knowledge of treatment is greater than our capacity to deliver it. NIMH looks at not just efficacy but at real-world effectiveness of treatments. Large pharmaceutical companies support research to develop new treatments but have focused on efficacy in very tightly controlled populations. NIMH has launched large, multi-site studies that are currently using a range of measures that now include improvement in function rather than just reduction of symptoms. NIMH is interested in looking at complementary and alternative medicine treatments where there is little outside support for research and development.
NIMH and NCCAM have some common interests and have already collaborated on several research activities. For example, they co-sponsored the recently completed clinical trial of St. John's Wort for major depression of moderate severity, are co-funding a clinical trial of St. John's Wort for the treatment of minor depression, and in 2002 jointly issued two Requests for Applications (RFAs) on the placebo effect. There are other opportunities to explore for continuing these synergistic collaborations, for example in the area of psychoneuroimmunology.
NIMH assesses its portfolio and future research activities within the context of a matrix system introduced by Dr. Elias Zerhouni, Director of NIH. The axes of the matrix are increasing risk and increasing time. Dr. Insel stated that discussion among two or more NIH Institutes/Centers would be helpful in accomplishing concepts that are identified in the matrix. Dr. Straus concurred that the collaboration is a very important aspect and he expects a fruitful dialogue, given the background of NCCAM's new deputy director and the expertise of members of NACCAM.
One Council member inquired about approaches to research on depression. Dr. Insel stated that researchers are thinking about depression as more than a mental disorder: it also affects bones, the cardiovascular system, and the endocrine system. Although it has been defined by the mental symptoms, those are not always the most profound.
IV. Annual State of the Center Report
Dr. Straus began his remarks by introducing NCCAM's new deputy director, Dr. Margaret Chesney. Dr. Chesney, the first NCCAM Deputy Director and new Director of the Division of Extramural Research and Training, hails from the University of California, San Francisco (UCSF) where she was professor of medicine and epidemiology at the UCSF School of Medicine and co-director of the Center for AIDS Prevention Studies and director of the behavioral medicine and epidemiology core of the UCSF Center for AIDS Research. Dr. Chesney will partner with Dr. Straus assisting with planning, directing, and managing the Center's programs and resources. He also introduced the meeting's participating ad hoc Council members: Drs. Mahlon DeLong, Eric Lien, Joost Oppenheim, and Jesse Roth. In addition, Dr. Straus thanked three members of the Council—Drs. Pardes, Grimm, and Cantwell—for extending their service, pending appointment of the new slate of nominees.
The first set of slides focused on a historical review of the Center's budget. Between Fiscal Year (FY) 1999 and FY 2003, the NIH budget doubled. During that same time, NCCAM's budget increased at a slightly greater rate. Yet, the estimated figure for FY 2003 suggests that NCCAM's rate of increase will begin to slow due to the Center's growing commitment base and its anticipated FY 2003 funding level. At the time of the meeting, there was wide uncertainty about FY 2003; the NIH and its constituent parts were operating under a continuing resolution, which supports the agency at its FY 2002 funding level and precludes it from initiating new projects or activities.
Following his discussion of the Center's recent appropriations history, Dr. Straus presented trend data on the Center's success rates. He noted that NCCAM's success rate in 2002 (14 percent) is considerably lower than NCCAM's success rate in 1999 (56 percent). A lower success rate means NCCAM has been funding fewer projects as compared to the number of applications it has received. If the rate of funding awards continues to decrease, NCCAM may have to consider taking steps to ensure it is able to support a respectable level of high quality awards and other critical research activities. The possible implications of slower growth in funding include fewer new awards, initiatives, and pivotal clinical trials; it may also discourage experienced applicants from applying and lead to an overall lower quality of applications. Specific actions NCCAM could take in response to slower growth include evaluating grants by mechanism, awarding fewer large grants, reducing the length and amount of awards, and prioritizing disease targets and prioritizing awards among CAM domains.
NCCAM's investment in research project grants (RPGs) has increased five-fold in five years, from $10 million in 1999 to $50 million in 2003 (est). Both the quantity and quality of RPGs that NCCAM is funding has increased. In 2000, approximately 48 percent of NCCAM applications were unscored. In 2002, 35 percent of NCCAM applications were unscored, and 2.3 percent of applications received priority scores in the range of 100 to 120—a feat not accomplished prior to 2002. These accomplishments demonstrate how NCCAM is maturing as an institution. Another indicator of NCCAM's maturity is the size of its overall research project portfolio.
In 2002, NCCAM supported 9 new and 61 active R01 awards, 33 new and 73 active R21 awards, and 12 Small Business awards.
NCCAM's investment in its research centers program has not fluctuated as much as the Center's investment in RPGs. Given that the research centers are re-competing in FY 2003, NCCAM convened an expert panel meeting in 2002 to reassess the role of the centers. The report issued by the panel led Council to approve an initiative for centers using the P01 and U19 award mechanisms. A reassessment of NIH's botanical centers will be completed during 2003, with a report to the Advisory Council in September 2003.
With respect to NCCAM's Intramural Research Program, its expenditures increased from zero in 1999 to $5 million in 2003 (est).
Dr. Straus then summarized NCCAM's clinical research activities. Dr. Straus stated that while NIH funds a higher percentage of its budget on pre-clinical research than does NCCAM, which funds mostly clinical research, this ratio is likely to change in the future. In FY 2002, the five CAM domains comprising the Center's research portfolio are biologically based systems (56 percent); alternative medical systems (18 percent); mind-body medicine (12 percent); manipulative and body-based systems (8 percent); and energy therapies (6 percent). An ongoing challenge for NCCAM is achieving balance among these five domains. Dr. Straus speculated that, in the future, the percentage of biologically based projects would likely decrease, while the percentage of mind/body projects could increase.
Dr. Straus reported on the status of eight of NCCAM's major Phase III clinical trials. Most are proceeding according to plans. However, the St. John's Wort for minor depression trial has been delayed due to problems with acquiring standardized product. Nonetheless, patient enrollment will begin this year. He discussed the significance of the Ginkgo biloba for dementia trial (the largest herbal medicine study ever conducted)–particularly in light of recent NCCAM-supported findings regarding the cellular mechanisms of Ginkgo biloba.
A measure of NCCAM's success is the number of publications its grantees have authored. A total of 138 OAM/NCCAM grants have published 335 manuscripts. NCCAM has had a number of other accomplishments. For example, in 2002, the Center supported seven workshops. NCCAM is planning a State of the Science meeting with the Office of Medical Applications and Research and the National Institute on Aging to address the management of menopausal symptoms. This meeting will incorporate discussions of CAM results and future research directions. In 2002, NCCAM secured the support of 16 other federal agencies to co-sponsor an Institute of Medicine (IOM) study on the scientific and policy implications of CAM use by the public.
This two-year study will provide an overview of usage of CAM therapies by the American public, while identifying significant scientific and policy issues related to CAM research.
NCCAM has experienced dramatic growth in its training and career awards. In fact, since 1999, expenditures in this area have grown ten fold. In the communications area, NCCAM also achieved numerous goals. In 2002, the Center redesigned its web site, held its third national town meeting, established a distinguished lecture series, and arranged to co-sponsor a six-week lecture series with the Smithsonian Institution. The statistics suggest that the public is responding enthusiastically to NCCAM's outreach efforts. The web site logged more than 1.3 million visitors last year, while the information clearinghouse experienced a 35 percent increase in inquiries. More than 80 new fact sheets are now available on the web site. In 2002, NCCAM staff presented more than 60 lectures on CAM. As part of outreach to CAM and minority institutions, NCCAM staff delivered keynote addresses and attended the annual meetings of professional societies, while also apprising investigators of minority research supplements and visiting two historically black colleges to encourage potential grant applicants.
One of NCCAM's most recent organizational accomplishments is the start-up of its intramural research program. Dr. Marc Blackman, NCCAM Clinical Director, launched the program's first protocol in June 2002. Also in 2002, NCCAM appointed Dr. Michael Quon as the intramural program's first tenured scientist. In addition, last year, NCCAM's extramural program established the Office of Clinical and Regulatory Affairs (ORCA). ORCA is developing guidelines to govern the quality of botanical products used by investigators, as well as defining terms of awards for clinical trials. The Office will also conduct biostatistical review of all NCCAM-sponsored trials. Finally, NCCAM recruited its first Deputy Director in 2002.
Comments and Questions
Dr. Goldstein suggested that NCCAM exercise caution when selecting very specific research priorities. NCCAM might want to consider the best way to handle research proposals that grant the Center maximum flexibility and the ability to respond to changing scientific opportunities and emerging targeted research areas. The R01 should continue to serve as the heart of the science; other mechanisms all feed into the R01 mechanism. NCCAM should consider ways to preserve R01 projects under any budget restrictions. The system must have flexibility and use specific administrative mechanisms to enable the Center to address a constantly changing research environment. All NIH Institutes have grown over time, but those that received the largest funding increases were linked to a specific research area. NCCAM may be approaching the point where it can identify an area of promise and will, therefore, need to bring in additional resources to supports its work in this area.
Dr. Roth said that NCCAM differs from other Institutes. Most Institutes/Centers focus on specific diseases and/or conditions. NCCAM has a fragmented constituency. If NCCAM had a disease, it would have a more natural constituency. NCCAM has thematic issues, however, and has been very successful at attracting collaborators. NCCAM should not give away research opportunities to other institutes. The Center needs a track record of accomplishment beyond pilot studies. Co-funding is good, but the Center should be able to cite accomplishments that it has solely supported.
Dr. Lien said that the implications of increasing longevity will become an issue of concern, and it cannot be addressed with a short-term study. Dr. Straus replied that it is a multi-faceted issue, one that NIH supports and NCCAM embraces as a priority area of scientific inquiry. Dr. Oppenheim noted that a number of professional and interest societies might be able to play a more active role in helping achieve mutual goals. Dr. Meeker added that the efforts by chiropractic and other professions have facilitated legislative action, including the creation and continued funding of NCCAM. There is not strong organization across groups, however, which might warrant a greater effort.
Dr. Cantwell said that selected parts of the portfolio seemed under-represented, especially mind/body medicine. He urged NCCAM to work with NIMH to increase its investment in that area. NCCAM is the only organization that will investigate whole systems, such as homeopathy and naturopathy. NCCAM's unique interests should be a consideration in constructing the portfolio. Research on energy medicine, for example, will only happen at NCCAM.
V. 2003 Report: Compliance with the NIH Policy on Inclusion Guidelines—Overview
Dr. Straus next introduced Dr. Vivian Pinn, Associate Director for Research on Women's Health at NIH, who discussed the NIH policy on the recruitment and retention of women and minorities in clinical research. She presented a history of events that led to the current policy.
In 1990, the U.S. General Accounting Office (GAO) examined whether NIH could document how many women were included in clinical trials and if there was a consistent policy in place across NIH. The GAO report led to a requirement that NIH-funded clinical trials include women and minorities. NIH issued revised guidelines in 1993 and 1994. The National Institutes of Health Revitalization Act of 1993 (PL 103-43) stated what was already becoming policy: that NIH ensure the inclusion of women and minorities in all human subject research where appropriate; include women, minorities, and subpopulations in Phase III clinical trials in sufficient numbers to accomplish a valid analysis of any differences; not allow cost as a rationale for excluding these groups; and initiate and support outreach in recruitment of women and minorities into clinical trials.
The Act also mandated that “[t]he Advisory council of each national research institute (and center) shall prepare biennial reports describing the manner in which the institute (center) has complied” with the requirements. The Office of Research on Women's Health (ORWH) compiles the information provided by each institute and center into a biennial report from the NIH Director to Congress.
In 2000, GAO conducted another study, which showed that NIH had strengthened its efforts, but which also identified some remaining issues: some scientific publications did not include analysis by gender. NIH does not dictate the journals' editorial policies, and therefore could not obligate them to include the data. Since the concerns were raised, NIH is redoubling the efforts to verify data.
Failure to include women and minorities in a grant application to NIH on human subjects research results in the application being returned prior to review or deferred from further review. The sections of applications discussing the plans for inclusion of women and minorities must address subject selection criteria and rationale; rationale for any exclusion; the start and end dates for enrollment; outreach plans for recruitment; and proposed composition tables. Peer review groups must ensure that each of these features is present in the applications they consider. Unacceptable plans must be reflected in the priority score and documented in the minutes of the review section. The Advisory Council also ensures that a grant is not approved for funding if a plan is unacceptable.
The NIH inclusion policy requires compliance from everyone involved in the research, from the PIs to program staff to the public. The 2001 ORWH report, on the ORWH page of the NIH Web site, shows the data for Fiscal Years (FY) 1999 and 2000. ORWH has begun to collect data on FY 2001 and 2002 from the Advisory Councils for inclusion in the next report.
The aggregate NIH data from the 2001 report show more women than men in both Phase III clinical trials and in all human subject trials. Excluding sex-specific studies, however, there is no significant difference. Some gender-specific studies are revisiting prior studies in which women were left out.
Dr. Pinn further explained that while the guidelines apply to all human subject research, the analysis requirement is limited to Phase III studies. In response to a question about the definition of “minority,” in view of the increasing number of interracial marriages and other factors, Dr. Pinn explained that the definitions come from the Office of Management and Budget (OMB) and are in the ORWH reports.
VI. 2003 Report: Compliance with the NIH Policy on Inclusion Guidelines—NCCAM Report
Dr. Josh Berman, Director of the Office of Clinical and Regulatory Affairs, next presented NCCAM's inclusion report for 2000 and 2001. He showed tables summarizing information about individuals enrolled in NCCAM-sponsored clinical research.
In 2000, 6,160 patients participated in NCCAM studies. The female and male percentages were 52 percent and 48 percent for all NCCAM extramural clinical research and 51 percent and 49 percent for phase III research. To summarize the racial/ethnic characteristics of patients in all clinical research: 85 percent were white, 9 percent were black, 3 percent were Hispanic, 1 percent were Asian, and 0.1 percent were American Indian/Alaskan native.
In 2001, the number of patients approximately doubled to 11,772, but the distribution across populations was similar. The female and male percentages were 52 percent and 48 percent for all NCCAM extramural clinical research and for phase III clinical trials. In terms of racial data: 84 percent were white, 10 percent were black, 2 percent were Asian, 0.4 percent were American Indian/Alaskan native, and 0.1 percent were Hawaiian/Pacific Islander. In terms of ethnic data: 6 percent were Hispanic or Latino.
A motion was made to accept the data in the report that Dr. Berman presented. The motion passed unanimously.
VII. Council Operating Procedures
Dr. Kinsel presented a draft Council operating procedures document, summarizing the role of the Council in advising NCCAM. There were two main areas discussed. The first is what is commonly called the “closed session” of the Council meeting, which provides second level peer review of research applications assigned to NCCAM. The document lists the options that Council has in grant review, and contains a section regarding administrative decisions and actions that do not require Council approval. The second area, topics discussed during the open session of Council meetings, includes concepts for research initiatives, policy and research priorities, and NCCAM reports to Council. Because NCCAM is committed to keeping the Council informed, the Council will be asked to review the operating procedures on an annual basis.
Dr. Cantwell asked if there is a guideline for the composition of the Council. Dr. Straus replied that there is a matrix that guides the nomination and appointment of members to all NIH advisory committees. NCCAM has complied with these guidelines. One challenge is defining “CAM practitioner,” since licensure varies from state to state. Dr. Kail noted that continuity is a concern since a number of Council members are due to rotate off the committee. Dr. Straus explained that the nomination package has been sent to DHHS and stated his hope that the new slate will be approved before the June Council meeting. A motion was made to accept the document and the vote was unanimous in favor.
VIII. Concept Clearances
Probiotics for the Prevention and Treatment of Pediatric Illnesses
Marguerite Klein, NCCAM, presented the first research concept on the use of probiotics to treat and prevent pediatric illnesses. Only a few grants at NIH have been awarded in this area. Probiotics are living organisms that, when administered in sufficient quantities, may improve health by altering microflora. Routes of administration can be oral (e.g., food, dietary supplements), parenteral, injection, or suppository.
Benefits may include treatment of antibiotic-related side effects and diarrhea, prevention and treatment of diarrhea and gastroenteritis, treatment of inflammatory bowel disease, enhancement of oral vaccine administration, and treatment and prevention of allergies and atopic eczema.
The proposed Request For Applications (RFA) would solicit research through R21s and R01s, with the goal of studying mechanisms of action, creating pilot data for future research, establishing dosing levels, determining safety and efficacy, and comparing various agents. This initiative would also expand NCCAM's small pediatric portfolio.
There was much discussion for and against the concept. One question concerned the need for NCCAM to get involved, since this is also an area of interest in the conventional medical community. In response to a comment that conventional medical practitioners use probiotics, it was pointed out that there is a need to conduct good research to demonstrate whether or not the approach is effective. Other NIH institutes have expressed interest in the concept.
A vote was taken on developing the concept as an RFA. The initial vote was five in favor, five opposed, and two abstentions. Dr. Straus proposed that the initiative be announced as a Program Announcement with no set-aside funds to simply encourage applications. On a vote on this proposal the concept passed, with the majority in favor.
Dietary Supplement Analytical Resource Center
Ms. Klein next presented a concept to establish an analytical resource center, using a contract mechanism, to ensure the quality of products used by NCCAM grantees. This multi-disciplinary center would assure the character and quality of biologically active agents used in NCCAM studies. Certain products are already being standardized by NCCAM-funded grants. The testing would cover product composition and contamination, along with a variety of characteristics such as bioavailability and stability. Tested products would remain in a library for reference purposes.
Ms. Klein added that while costs have not yet been determined for this specific contract, there would be developmental costs. The Office of Dietary Supplements has indicated an interest in cosponsoring the initiative. The vote in favor of approving the concept was unanimous.
CAM Research Planning Grants
Dr. Goertz of NCCAM presented the final project concept, CAM Research Planning Grants. This proposal follows a previous discussion at the August 2002 Council meeting regarding Centers concepts. The proposed Program Announcement is designed to solicit grants to help develop a plan to build research infrastructure via partnerships between conventional and CAM institutions. Only CAM institutions would be eligible.
The grants would lead to further definition of research to be proposed in subsequent competitive grant applications, and develop an infrastructure plan that would address personnel and other resource needs so that future research can be conducted successfully and ethically. Funding would be through the R03 mechanism, with no set-aside funds.
Dr. Straus added that this proposal follows an analysis of activities in this area and interest from the research community. The applications would be limited to 10 pages to reduce the paperwork. Dr. Goertz explained that approximately two dozen institutions would qualify, such as colleges of chiropracty and naturopathy, as well as schools of acupuncture, massage, and Oriental medicine. The assumption is that the CAM institution would have contacts and would be working with a conventional institution already. The concept was approved, with 10 in favor of the concept, and two abstentions.
IX. Public Comment Session
Dr. Steven Dentali of the American Herbal Products Association spoke about the concept for the analytical resource center. Quality control is important, but must be tailored to meet the requirements of each product. The complete standardization of many products will be fully developed only over a period of time.
Dr. Straus adjourned the meeting at 4:50 p.m.
We hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.
Jane F. Kinsel, Ph.D.
National Advisory Council for Complementary and Alternative Medicine
Stephen E. Straus, M.D.
National Advisory Council for Complementary and Alternative Medicine