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Minutes of the Eighth Meeting - August 27, 2001
National Advisory Council for Complementary and Alternative Medicine (NACCAM)
On this page:
- Call to Order
- Opening Remarks
- Overview of NHLBI Activities
- Interim Report: White House Commission on Complementary and Alternative Medicine Policy
- Initiative Update
- Concept Clearances
- Public Comment
- Concept Clearances (continued)
- Council-Initiated Discussion
- Closed Session
- *Dr. Brian Berman, Department of Complementary Medicine, Kernan Hospital, Baltimore, MD
- Dr. Michael Cantwell, Complementary Medicine Research Institute, California Pacific Medical Center, San Francisco, CA
- *Dr. Zang-Hee Cho, Professor, Radiological Sciences, Psychiatry and Human Behavior, and Ophthalmology, University of California at Irvine, CA
- Dr. Haile T. Debas, Dean, School of Medicine, University of California, San Francisco, CA
- *Dr. Murray Goldstein, UCP Research and Educational Foundation, Washington, DC
- Dr. Richard H. Grimm, Director, Department of Internal Medicine, Berman Center for Outcomes and Clinical Research, Minneapolis, MN
- *Dr. Michael Irwin, San Diego Veterans Affairs Medical Center, San Diego, CA
- Dr. Janet Kahn, Peace Village Projects, Burlington, VT
- Dr. Konrad Kail, Naturopathic Physician, Naturopathic Family Care, Phoenix, AZ
- Dr. Ted Kaptchuk, Asst. Prof. of Medicine, Harvard Medical School, Boston, MA
- Ms. Diana C. Manley, Massage Therapist, New Bern, NC
- Dr. William Meeker, Director of Research, Palmer Chiropractic University Foundation, Davenport, IA
- Dr. Everett R. Rhoades, University of Oklahoma College of Public Health, Oklahoma City, OK
- *Dr. Connie Weaver, Department of Foods and Nutrition, Purdue University, West Lafayette, IN
- Col. James Williams (Ret), Pennsylvania Prostate Cancer Coalition, Camp Hill, PA
*Ad Hoc members
- Ms. Julia Arnold, National Center for Complementary and Alternative Medicine (NCCAM)
- Mr. Christopher Baron, NCCAM
- Ms. Willer Batten, NCCAM
- Dr. Mark Blackman, NCCAM
- Mr. Brian Campbell, NCCAM
- Ms. Victoria Carper, NCCAM
- Dr. John Chah, NCCAM
- Ms. Karen Dunlap, NCCAM
- Ms. Marguerite Evans, NCCAM
- Ms. Carol Fitzpatrick-Mulligan, NCCAM
- Dr. Christine Goertz, NCCAM
- Dr. Martin Goldrosen, NCCAM
- Ms. Nicole Gottlieb, National Cancer Institute (NCI)
- Ms. Anita Greene, NCCAM
- Dr. Peter Greenwald, NCI
- Dr. Stephen Groft, WHCCAMP
- Mr. Lawrence Haller, NCCAM
- Dr. Nancy Hazelton, NCCAM
- Mr. Earl Hodgkins, NCCAM
- Ms. Camille Hoover, NCCAM
- Dr. Morgan Jackson, NCCAM
- Dr. Jane Kinsel, NCCAM
- Dr. Claude Lenfant, Director, National Heart Lung and Blood Institute (NHLBI)
- Ms. Irene Liu, NCCAM
- Dr. Patrick Mansky, NCCAM
- Dr. Richard Nahin, NCCAM
- Ms. Ellen O’Donnell, NCCAM
- Ms. Katharine Pabst, NCCAM
- Dr. Nancy Pearson, NCCAM
- Mr. Marc Pitts, NCCAM
- Ms. Aurora Ramos-Castillo, NCCAM
- Dr. Mary Ann Richardson, NCCAM
- Dr. Joana Rosario, NCCAM
- Ms. Andra Standberry, NCCAM
- Dr. Stephen Straus, Director, NCCAM
- Ms. Jennifer Tisch, NCCAM
- Dr. Neal West, NCCAM
- Ms. Kerry Whichard, NCCAM
- Dr. Jeffrey White, NCI
- Ms. Allison Wise, NCCAM
- Dr. Shan Wong, NCCAM
- James Bernstein, ASPET
- E. Borehini, DHHS/HRSA
- Hannah Bradford
- Dr. Jerry Cott
- William J. Cutts, Cranberry Institute
- Dr. Cathy Fomous, CFN
- Dr. James Gordon
- Marsha Holton, CCRN
- Scott Jenkins, FDC
- Yoshi Kato, SKK
- Dr. Freddi Kronenberg, NYC
- Jennifer Kurde, AADS
- Jeffrey Lafler, Cranberry Associates
- Linda Lazanaere, DOE
- Corey Mackison, Aspens
- Michael Marcoux, FDC
- Nancy Moy, SRI
- Michael Musent, Alternative Therapy
- Sean O’Shea, Ocean Spray
- George Persons, PG Associates
- P. Seefield, Florida
- Yamamoto Shintaro, SKK
- Joe Spereri, Ocean Spray
- Edith Taylor
- Mary Wang
- Wotton, AMFI
- Meshe Zilberst, FDA
The National Advisory Council for Complementary and Alternative Medicine (NACCAM) convened at 8:30 a.m. on August 27, 2001, at the NIH Neuroscience Conference Center in Rockville, Maryland. Dr. Jane Kinsel, Executive Secretary, called the meeting to order and reviewed the agenda: presentations by Dr. Claude Lenfant of the National Heart, Lung, and Blood Institute (NHLBI), and Drs. James Gordon and Stephen Groft of the White House Commission on Complementary and Alternative Medicine; a public comment session; presentation of four concepts; an opportunity for Council-initiated discussion; and a closed session at the end of the day.
A November conference call to discuss grants and other business was being scheduled to replace the October Council meeting. Dr. Kinsel reviewed the general rules under which Council must operate. The general public may attend the open session; as required by law, there was an opportunity for public comment. The closed session 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).
Dr. Stephen Straus thanked Dr. Kinsel for taking on the role of Council executive secretary and thanked Dr. Richard Nahin for his prior service in that role. He welcomed the ad hoc members: Drs. Weaver, Goldstein, Berman, Cho, and Irwin.
Dr. Straus introduced new NCCAM staff. Chris Thomsen heads NCCAM’s office of communications and public liaison. Prior to coming to the center, she headed the National Cancer Institute (NCI) Cancer Information Service, where she strengthened outreach and communications. She has collaborated with many cancer organizations worldwide. Dr. Patrick Mansky is the first staff clinician in the intramural program. He trained in medicine in Germany, where he did clinical rotations in several CAM areas. He is board-certified in the United States in internal medicine, pediatrics, and oncology.
DHHS Secretary Thompson is spending one week at each health agency; he visited NIH the previous week, visiting many facilities and meeting with institute/center directors, including Dr. Straus. Secretary Thompson is enthusiastic about what NCCAM is doing.
For several months, the administration froze hiring at NIH. The freeze has been partially lifted and NCCAM can resume hiring. Since Council members are special government employees, the approval of new Council members was postponed by the freeze. The nomination slates for new Council members are now moving forward.
On May 14, 2001, NCCAM and the Office of Dietary Supplements (ODS) held an industry colloquium with over 200 government and industry representatives. This meeting included raw material suppliers, manufacturers, and organizations that develop standards to determine the safety of these products. The major talks can be accessed on the NCCAM web site (www.nccam.nih.gov). A meeting summary was published in the October issue of the Journal of Complementary and Alternative Medicine.
Dr. Straus introduced Dr. Claude Lenfant, director of the National Heart, Lung, and Blood Institute (NHLBI). Dr. Lenfant explained that NHLBI is one of the oldest NIH institutes, created in 1948 with the mandate to improve the health of the people of the U.S. through the conduct of research, investigations, experiments, and demonstrations relating to the cause, prevention, and methods of diagnosis and treatment of disease of the heart and circulation. The mission has evolved over time; for example, NHLBI conducts sleep research now. In this regard, Dr. Lenfant suggested that NCCAM join the trans-NIH sleep advisory committee. The Institute has contributed to considerable increases in life expectancy, much of which is due to the decrease in cardiovascular disease brought about by the improvements in lifestyle, diet, diagnostic and treatment modalities developed by NHLBI-funded investigators.
NHLBI has been doing behavioral research since the early 1970s, and the financial commitment to behavioral research has been impressive. NHLBI considers behavioral medicine to be an integral part of medicine. Such research has resulted in a better understanding of the relationship between high stress-related systolic blood pressure and the likelihood of stroke, the hyperactivation of specific areas of the brain during mental stress in coronary heart disease patients, and the relationship between impaired cardiac function during mental stress and the increased likelihood of death within five years.
NHLBI has supported work by Dr. Dean Ornish. Other relevant examples of NHLBI projects include a center for mind/body interactions and health, trials of hypertension prevention through stress management, biofeedback for Raynaud’s disease, cognitive behavior therapy for depression, the benefits of soy phytoestrogens, and traditional cultures’ treatments of cardiovascular disease. NHLBI has supported studies of CAM treatments for asthma, including acupuncture, hypnosis, herbal remedies, dietary supplements, and homeopathy.
Dr. Lenfant highlighted an example of how NHLBI and NCCAM are collaborating to support research in the cardiopulmonary area. The chelation therapy workshop was successful, resulting in a joint request for applications (RFA) on chelation therapy that will be funded in FY2002.
In response to a question about asthma, Dr. Lenfant noted that the same number of people suffer from asthma and cardiovascular disease, but the latter is more lethal. NIH supports numerous research projects on asthma, from basic through applied research. NHLBI has an education program on asthma, leads the national program on asthma, and supports international activities. Self-management can play a major role in ameliorating symptoms. Dr. Straus added that NCCAM is committed to studying CAM approaches to asthma and called twice for proposals for asthma centers but did not receive applications that were deemed sufficiently meritorious. In response to a comment about dietary approaches to asthma, Dr. Straus referred to a dietary concept that the Council had rejected. NCCAM remains interested in this research area.
In response to a question about how patient advocates are integrated into NHLBI programs, Dr. Lenfant explained that the Institute convenes an annual meeting of groups that are interested in its work. Over 100 voluntary and professional organizations and support groups for all diseases of interest to NHLBI meet with staff to discuss areas of potential research. This has resulted in some extraordinarily successful studies. In addition, patient advocates are included as lay members on NHLBI’s advisory council.
Dr. Kinsel introduced Dr. James Gordon, chair of the White House Commission on Complementary and Alternative Medicine Policy, and Dr. Stephen Groft, executive director of the Commission.
Dr. Groft thanked Dr. Straus for providing critical financial and administrative support for the Commission. A decade ago, Congress first included language in an NIH authorization for studying unconventional medical practices. Nine years later, he found himself preparing the agenda for the White House Commission. The Commission expects to issue its final report by March 2002.
Dr. Gordon noted that the Commission has heard testimony from over 1,000 people in six Commission meetings and four town hall meetings across the country. This has involved a large cross-section of people, ranging from those who’ve spent their entire lives in CAM to solo practitioners to patients to conventional practitioners and scientists. Much of the testimony is posted on the web site (www.whccamp.hhs.gov).
There is a deep interest in an integrated approach to medicine and an acknowledgment that people need to be treated as unique. There has been a growing appreciation toward the importance of self-healing, and an emphasis on the engagement of people in health care at all levels.
Coordination of research is another area of focus by the Commission. The Commission is interested in the research efforts of and collaborations among agencies, such as the Veterans Administration and the Defense Department. Regarding education and training, it is clear from the input received that there is a need for more education about CAM practices for health professionals at all levels of their training. There is also interest in promoting CAM education at the post-graduate and continuing medical education levels. On the other side, it is important that CAM professionals understand the basic vocabulary of conventional scientific professionals so that the two groups better understand each other.
There are limitations of access to CAM therapies, many of which are economic. There are also limitations of information about CAM. Nor are there many models of successful integrative practice and outreach to the community. Therefore, the Commission hopes to encourage development of these models. The Commission has an interest in developing and researching models as a major focus—insurers are very interested in this and want to know how to do demonstration programs.
The Commission is developing an algorithm for coverage and reimbursement. The Commission would like to see demonstration projects at the Federal level to show how these approaches can work and if they present cost savings. Wellness, self-care, health promotion, and disease prevention together form an area about which the Commission is passionate, since these are among the highest goals of CAM. They want greater Federal/private sector coordination, through a central office or mechanism.
Dr. Gordon invited the Council members to attend the October meeting, which would address draft recommendations for the final report.
Dr. Goldstein asked if any of the recommendations might lead to the establishment of human population labs. His concern was how to study wellness, prevention, and similar concerns. He noted that it is easy to study disorders, but it is difficult to study health. Many elderly people are living in retirement communities; Dr. Goldstein suggested that they might constitute such a lab.
Mr. Williams suggested a marketing campaign on the national level, for example, health and wellness commercials instead of beer commercials at sports events to reach men. Dr. Kail said that the entitlement language in Medicare and other programs seems to be tied to the outcomes of research projects. He was concerned, since it takes time to establish outcomes. He encouraged the Commission to emphasize demonstration projects as a way to encourage access.
In response to a question about the interaction between the Commission and NCCAM, Dr. Gordon said that NCCAM’s work has informed much of what the Commission has done. Dr. Straus added that the Commission provides a unique opportunity to hear very broadly from stakeholders. The Commission’s work will inform the evolution of NCCAM programs.
Concerning implementation of the report recommendations, Dr. Groft noted that there will be a continuum. The Commission will speak with federal agencies to see if the recommendations are feasible, how to improve them, and how to move them forward. The recommendations include legislative and administrative activities, which will take time. Dr. Gordon added that this document will provide a blueprint for what should happen. He hopes their document will be used as a basis for organizing CAM activities. Dr. Straus invited Drs. Gordon and Groft back to a future Council meeting to discuss the final recommendations.
Dr. Nahin discussed a handout that summarized NCCAM’s initiatives. He reminded the Council members of the criteria used to assess initiatives: preliminary data of reasonable quality and quantity; use by the public; mortality and chronic disabling impact; the cost of a study; the existence of a scientific community qualified to conduct the investigation; and the existence of a patient community to study.
NACCAM approved 16 initiatives in FY2000. NCCAM is trying to balance workloads for Council and staff. The plan is to bring one or two initiatives for review per Council round. In terms of modalities, through May 2001, NACCAM had approved one initiative in the energy modality, two for alternative systems, three for mind/body, seven for biologics, and nine in mixed modality. The latter include integrated medicine and education.
In terms of diseases or other areas covered, there is one initiative each for AIDS, asthma, cardiovascular disease, diabetes, and musculo-skeletal; three for training and education; four for cancer; and 10 in mixed areas. The latter includes initiatives that cover multiple diseases.
A handout listed each individual initiative. Only five initiatives have resulted in funded grants to date because of the time it takes between concept clearance to Council review of applications, which is usually a year or more.
In response to a question about how staff decides which mechanisms to use for an initiative, Dr. Nahin replied that there are budgetary and scientific/programmatic considerations. A program announcement (PA) is active for 3 years with no budget set aside. RFAs have specific money set aside for a one-time solicitation. Scientifically, a program announcement is less specific, while an RFA is more specific. For an extremely directed project, NCCAM may use an RFP to solicit contract applications.
Ms. Marguerite Evans presented the first concept, “Cranberry (Vaccinium macrocarpon) and Urinary Tract Infection (UTI).” The purpose of this initiative is to support basic and clinical research on the role of cranberry in the prevention and treatment of UTI. There is accumulating evidence from small, non-controlled and controlled clinical trials suggesting that cranberry may relieve symptoms and may reduce the need for antibiotics. Although studies reported in the literature suffer from major limitations, the findings from the preliminary research provide reasons to support the conduct of small-scale, focused clinical studies, but not a Phase III trial. In addition, emerging evidence indicates that cranberry may be useful in treating other conditions. NCCAM will seek collaboration with other institutes. This could broaden the scope of the concept as presented. NCCAM elevated the priority of this initiative due to language in the legislation directing NCCAM to support research on cranberry.
Discussion of the concept was primarily supportive. Suggestions included the need for a Phase III trial, product standardization, and studies with animal models to determine threshold levels. Ms. Evans stated that the literature, including the Cochrane reviews, did not support conduct of a Phase III trial at this time. NCCAM shared the concern about product standardization; plans are underway to provide well-characterized products (e.g., juice, concentrate or supplement) to the grantees. In response to the third comment, the solicitation will allow studies of efficacy and safety of varying dosage levels.
One Council member raised concern about the type of solicitation, e.g., PA vs. RFA, since this could affect NCCAM’s budget, which is beginning to level off. Collaboration with other institutes could include financial support. It will be easier to handle out-year costs resulting from an RFA soliciting R01s and R21s than one soliciting a Phase III trial. Responses to PAs are less predictable, but NCCAM may be using this mechanism more as future funding increases diminish and out-year commitments increase. There was a concern about the market driving NCCAM’s agenda. It would not serve NCCAM well to have many calls to study specific products. However, in this case, before congressional language was written, NCCAM was already looking at cranberry.
Council approved the concept.
A public comment session was held, as required by law.
Dr. Cathy Fomous, of the Council for Responsible Nutrition, made an announcement about a meeting to be held September 28 and 29 on performance enhancing products such as sports supplements. Senator Hatch was scheduled to attend. The conference was co-sponsored by the Office of Dietary Supplements. Further information was available at the ODS web site or at www.crnusa.org/pep.html.
Ms. Marsha Holton from HMP Communications noted that her organization has a session teaching people to become more aware that patients and staff are using CAM on a daily basis. As health care professionals, nurses need to be aware of what patients are taking and doing.
Dr. Neal West presented a concept entitled “Basic and Pre-clinical Research on Complementary and Alternative Medicine (CAM).” The purpose of this concept is to stimulate the quantity and elevate the quality of basic, mechanistic, and pre-clinical research in all domains of CAM in order to provide a stronger foundation for ongoing and planned clinical studies. A number of examples were given, including mechanisms of neuroprotective effects of herbals and other natural products in neurodegenerative diseases; chemical and physical reactions during the dilution process and the principles of physics underlying homeopathy; and basic biological mechanisms and processes underlying acupuncture. The proposed initiative will help raise researcher awareness of and interest in pursuing basic, mechanistic, and pre-clinical CAM research. A program announcement will raise NCCAM’s visibility across broad communities and will simultaneously help to erase the misperception that NCCAM is primarily a clinical research institution.
A concern was expressed that there are other initiatives already approved which may be precluded by this broad program announcement. Dr. West said that at any one time, there may be several initiatives in various stages of preparation, and that the final timing and specific goals of each RFA or PA are adjusted based on budgetary and scientific needs at the time of release. What this concept and the proposed more general PA attempt to say is that applicants need not wait for an RFA or more narrowly drawn PA to apply to the NCCAM for basic, mechanistic, or pre-clinical research grant support. For instance, the Frontier Medicine initiative supports basic research, but only in the context of a relatively few multi-project centers which must also include clinical studies. A Council member added that basic science will save money for clinical research in the long run.
Several members said that they thought it was an excellent concept, and expressed the view that basic scientists are interested in this field, but need encouragement and funding. In response to a question about how the broadest possible basic and pre-clinical research communities will know about this initiative, Dr. Straus explained that in this particular case the NCCAM will go beyond the standard means of publicizing initiatives. NCCAM is advertising this initiative in major scientific journals.
The Council unanimously approved the concept.
Dr. Morgan Jackson presented a concept, “Botanical/drug interactions and HIV.” Persons with HIV have a higher use of CAM compared with the general public. A quarter of them use botanicals; prescribing physicians often do not know of this. Concurrent use of herbs and highly active anti-retroviral therapy (HAART) can have potentially harmful interactions. With the numerous herbs used by persons living with HIV/AIDS, research is needed to identify additional herb/drug combinations that may pose risks or that may afford beneficial synergistic effects. The main objectives of this initiative are to gain information that can help prevent adverse interactions, to establish possible synergistic combinations, and to increase knowledge of the mechanisms of action of botanicals. The proposal will use R21 (2 years) and R01 (4 years) funding mechanisms.
The Council approved the concept.
Dr. Joana Rosario presented a concept, “International Collaborative Research Program (ICReP).” Its purpose would be to develop an international site of CAM research replicable to other locations; to strengthen international research collaborations with U.S. investigators; and to increase the quality and number of international research applications to NCCAM. This initiative would help create programs to attract the best and brightest overseas researchers to CAM. It will provide opportunities for U.S. investigators to help improve understanding of health disparities. It will include multiple interrelated research projects, each with an international and U.S. investigator, conducted at an international site for up to five years. They will be joint PIs, and will share resources. There will be annual evaluations, enrichment activities, and peer review.
Training will be a key element of the program. International investigators could acquire or enhance specific research skills in the research institutions of their U.S. collaborators, and each project could provide research training opportunities at diverse levels of training. The funding mechanism will be the U19 cooperative agreement, which supports research programs of multiple projects directed toward a specific major program goal. Substantial NCCAM staff involvement will be necessary.
Several key concerns were brought up by Council members during a lengthy discussion: 1) whether the international community was allowed to participate in the development of this concept; 2) restriction of the initiative to developing countries in which basic research infrastructure may be lacking and the political/economic status unstable could lead to preprogrammed failure of the grantees; 3) there has been a brain drain to developing countries over the last 20 years, such that there may not be a sufficiently large, well-trained group of foreign investigators in one location to compete successfully for one of these U19 grants; and 4) the goals and outcomes of the concept were not clearly stated. However, Council also noted substantial strengths that outweighed the potential weaknesses: 1) the concept was seen as very exciting, visionary and timely, and an important tool to increase the research capacity and quality of research in developing counties; 2) potential benefits are enormous by tapping into the traditional medicine expertise, both clinician and scientist, in many developing countries; and 3) the point was made that a similar OAM program in the early and mid 1990’s, the U24 program, had been used successfully to stimulate research on CAM at major academic centers.
Council approved the concept.
During the time reserved for Council-initiated discussion, Dr. Goldstein raised a topic that seems to be gaining interest with the public despite little supporting information. Hyperbaric oxygen has been useful in some areas, such as the bends. There are dangers, however. Persons at high risk of convulsive disorders may have seizures, although this is rare. Hyperbaric oxygen has become a popular intervention for people with stroke and children with cerebral palsy. Anecdotal evidence is varied. The chambers are relatively inexpensive and easy to use, but not controlled by the FDA. Storefronts are being set up with advertisements to come in for this “cure.” The mechanistic logic behind it is that after a cerebral infarction, cells in the area are on the metabolic edge. In about three weeks, according to a good Swedish study, the cells either recover or they stay impaired. The theory for those who five years ago had stroke or cerebral palsy is that the cells are still there and can be rejuvenated. The use of technologies such as PET scans might facilitate such a study. There was a recent controlled clinical trial in Canada published in Lancet. Dr. Straus mentioned that NCCAM has funded the University of Pennsylvania to study a hyperbaric approach to cancer. It was suggested that consideration be given to developing a concept for an initiative that would include both pre-clinical and clinical research.
The remainder 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).
The closed session began at 3:00 p.m. A total of 134 applications were assigned to and reviewed by NCCAM. Applications that were noncompetitive, unscored, or were not recommended for further consideration by the initial review groups were not considered by Council. Council reviewed and concurred with 87 applications requesting $47,018,428 in total costs. Of the 87 grant applications, 20 were reviewed by mail ballot in September.
There being no further business, the meeting was adjourned at 5:30 p.m.
We hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.
National Advisory Council for Complementary and Alternative Medicine
National Advisory Council for Complementary and Alternative Medicine