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Minutes of the Fourth Meeting - August 28 - 29, 2000
National Advisory Council for Complementary and Alternative Medicine (NACCAM)
On this page:
- Call to Order, Introductory Remarks and Meeting Procedures
- Introduction of Members
- Future Meeting Dates
- Review of Confidentiality and Conflict of Interest
- Director's Report
- View from another NIH Institute
- Report on the White House Commission
- Overview of the NCCAM Planning and Budget Process
- Public Comment
- Proposed Program Initiatives
- Call to Order
- Review of Applications
The National Advisory Council For Complementary and Alternative Medicine (NACCAM) convened at 8:30 a.m. on August 28, 2000 at the Doubletree Inn in Rockville, Maryland. Richard Nahin, MPH, Ph.D., Executive Secretary, called the meeting to order. The meeting was closed to the public on August 29 from 8:30 a.m. until adjournment as provided in Sections 552b(c)(4) and 552b(c)(6), Title 5 U.S. Code, and section 10(d) of Public law 92-463, for the review, discussion, and evaluation of grant applications and related information.
NACCAM Members Present (1)
- Dr. Michael Cantwell
- Ms. Mary K. Chung
- Dr. Haile T. Debas
- Dr. Richard Grimm
- Ms. Susan Holloran
- Dr. Janet Kahn
- Dr. Konrad Kail
- Dr. Ted Kaptchuk
- Dr. Anna Macintosh
- Ms. Diana Manley
- Dr. William Meeker
- Dr. Karen N. Olness
- Dr. Herbert Pardes
- Dr. Everett R. Rhoades
- Dr. Marilyn J. Schlitz
- Dr. Leanna Standish
- Mr. James E. Williams
- Dr. Dana Lawrence
- Dr. Sheryl Brining, NCCAM
- Ms. Linda Engel, NCCAM
- Ms. Marguerite Evans, NCCAM
- Ms. Carol Fitzpatrick, NCCAM
- Dr. Christine Goertz, NCCAM
- Ms. Christine Hollingsworth, NCCAM
- Ms. Camille Hoover, NCCAM
- Mr. Doug Hussey, NCCAM
- Ms. Kathleen Madden, NCCAM
- Dr. Richard Nahin, NCCAM
- Dr. Mary Ann Richardson, NCCAM
- Mr. Charles Sabatos, NCCAM
- Dr. Stephen Straus, NCCAM
- Dr. Neal West, NCCAM
- Ms. Shirley Villone, NCCAM
- Ms. Anita Greene, NCCAM
- Dr. Stephen Katz, NIAMS
- Ms. Anita Linde, NIAMS
- Dr. Jeffrey White, NCI
- Dr. Christine Swanson, ODS
- Dr. Paul Coates, ODS
- Dr. Stephen Groft, White House Commission
- Hanah Bafal
- Ellen Berman
- Jim Bernstein
- Catherine Campbell-Meshkin
- Beth Clay
- Dr. Jerry Cott
- Anita Cowan
- Alan Dumoff
- Catherine Eliot
- Judy Emery
- Martin Fisher
- Robin Gilmore
- Karen Hagerty
- Kurt Hegetschweilen
- Ann Jamison
- Jennifer Kunde
- Zhaneta Mansake
- Dr. Sandra McLanahan
- Nobuyuki Mizuki
- Dr. Roscoe M. Moore
- Al Nugent
- William Offit
- Richard Pavek
- Georgia Persinos
- Chris Peterson
- Steve Rafferty
- Neil Rosenberg
- Maury Silverman
- Jamie Stulin
- Jane Twitmyer
- Tao Wang
- Jim Zumwalt
OPEN SESSION - AUGUST 28, 2000
The meeting was called to order at 8:30 a.m. by Dr. Richard Nahin, Executive Secretary NACCAM. He introduced the two new members of the Council, Dr. Debas and Dr. Macintosh. Dr. Nahin discussed the procedures NACCAM council members must abide by and addressed the requirements of working under federal laws regarding open and closed sessions. The Monday session was to be open to the public, while the Tuesday session, during which individual grant applications would be reviewed, was to be closed and the material discussed confidential. Closed sessions were to follow federal guidelines. There would be an opportunity for public comment. Dr. Nahin then gave a brief overview of the meeting agenda. A sixth concept clearance was passed out just before the meeting. Among the materials in the council member folders was a letter of appeal from an applicant, to be discussed Tuesday. Another item was a copy of ethics rules for federal advisory panel members, which council members were required to read as part of annual ethics training.
Council members introduced themselves and stated their areas of expertise.
Dr. Nahin reviewed the meeting schedule. The next meeting will be November 13, 2000. In addition to the meetings on the list, there is a possibility of a November 2001 meeting; that decision will be made later. The dates for the 2002 meetings may change slightly.
Dr. Nahin reviewed conflict of interest and confidentiality requirements. A conflict of interest may occur when any of the following exist: (1) the member has a designated role in the research; (2) the member has a self-interest— professional or financial —in the research results; (3) there is even an appearance of conflict stemming from participation of a family member or associate of the NACCAM member. In addition, when an institution with which the reviewer is affiliated has an application under review, there is the appearance of conflict of interest even if the reviewer will not benefit financially and knows none of those involved in the proposed project. If any of these conditions were present, the NACCAM member was to withdraw from the discussion to prevent the proceedings from having an appearance of bias. Members are to refrain from discussing meeting topics outside the forum of NACCAM meetings. The review process should not be discussed with applicants; to do so would be a disservice to them and other applicants. If reviewers are contacted by applicants, the reviewers should refer them to NCCAM staff. Furthermore, committee members must not keep any materials distributed in a closed session. These materials must be left behind since they contained confidential information.
Dr. Straus noted that the NCCAM staff had been very busy, and they are likely to remain so. Eventually, both staff and council will have to be creative in reviewing the large number of applications they anticipate receiving. Dr. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), will be among those helping NCCAM broaden its scope. Dr. Straus noted that while he was about to report on recent activities, he hopes to give a more formal “state of the center” address each January.
As noted, the Center has been very busy; the staff has tripled, with much growth in the extramural program, review, communications, and other areas. More growth is necessary, for the present staff is working too hard. Major recruiting is occurring in several areas, including the intramural program and the international program. If candidates are not the best, however, they will start over with the search; he does not intend to compromise, although he does intend to keep things moving. They have been growing so rapidly that it has become hard to do space planning. Some staff will be moving to an off-site building, as there is not sufficient space on the NIH campus.
Growth is responsible for much of the increased spending. This year's budget was about $69 million plus almost $10 million in carry-over funds; they have spent all of the budget plus most of the carry-over. This represents a large increase in research. Congress is interested in supporting further growth, and at the time of the meeting was contemplating budget numbers between $78 and $100 million. This is exciting, but they should not grow faster than NCCAM's ability to manage and fund the best science. As the organization progresses, however, the science is getting better and better.
Dr. Straus cautioned that the numbers he had were rough, but the information he had at the time of the meeting indicated that while in 1999, NCCAM received 78 grant applications, in 2000 the Center had already received four times that many, and he expects a doubling of that number next year. As the rate of applications increases, so does funding, and at the same time, the overall quality of applications are higher. The Council's responsibility is now to fund the best of the best, not just the good or very good. Their efforts in this area will become increasingly important.
NCCAM is seeking assistance from around NIH. NCCAM has built support for technology transfer, working with other NIH organizations by sharing staff and resources in a variety of ways. They have been able to look at best practices at various other institutes and take advantage of that by seeking assistance from those institutes. What this means in reality is that NCCAM staff and resources are larger than what appears.
One area of responsibility is in communications with practitioners. NCCAM is also working to improve its web site and expanding the quantity and quality of the fact sheets. Another goal is to further develop the citation database. NCCAM will be calling for a new communications contract soon, to replace the current contract, which was issued in 1996. This will involve calling for competitive bids for contracts to help with the web site, the clearinghouse, correspondence, and other aspects of communications. Dr. Straus has testified before Congress and the House of Lords in London. The latter is putting together recommendations for activities in the United Kingdom similar to what NCCAM is doing. In addition, there was a town meeting in Boston, and NCCAM staff are planning another one in Tucson early next year. Another communications activity involved a competition to develop a new logo, which will be translated into all documents as time goes on. Finally, Dr. Straus will be speaking to the White House Commission on Complementary and Alternative Medicine Policy in October; Dr. Stephen Groft of the Commission would be speaking to the NCCAM Council later this morning.
Dr. Straus then introduced Ms. Engel, who discussed the strategic plan.
Ms. Engel noted that the strategic plan spanned the years 2001 to 2005. She provided background, summarized the input received, indicated how the document changed in response to comments, and outlined the next steps in plan evolution.
In terms of background, successive drafts built on the OAM draft plan and were reviewed by NCCAM staff, Council, and others. The draft was posted on the NCCAM web site for public comment for six weeks; NCCAM advertised broadly to direct people to this site. While the data are still soft, the initial profile of respondents was that there were 210 individuals, 111 form letters from one organization, and 25 organizations providing comments. Respondents placed themselves in multiple categories. The overwhelming number came from a CAM orientation rather than a conventional medicine background, and most (106) were CAM practitioners. Organizational responses were categorized as 21 CAM and four conventional medicine. The form letters came from the World Chiropractic Association, whose members felt they were inaccurately characterized.
Comments indicated overarching support despite some specific concerns. There were only a few naysayers. NCCAM staff received three types of comments: those on philosophical issues; policy questions; and notes about errors of omission and commission. An example of a philosophical comment was a suggestion to not dissect systems of medicine. Policy questions addressed insurance, cost-benefit analyses, and other issues that were not in NCCAM's venue; these were forwarded to the White House Commission. Citations of errors mostly noted the way things were portrayed or categorized.
The main strategic areas that were commented upon included the following: investing in research; training CAM investigators; expanding outreach; and facilitating integration. Many comments canceled each other out, in that some supported an action while others were opposed to it.
In finalizing the plan, the draft was rewritten in response to the many comments, then professionally edited. NCCAM added definitions and information on such topics as applying for grants. The editor amplified some points and ensured that all audiences could read and understand the document.
Immediate next steps are to take the document to a graphic arts department and have it printed. NCCAM will continue its planning process; this is a concept document only. On a continuing basis, NCCAM will take stock of goals; rank goals; and determine what is necessary to work towards goals.
Ms. Holloran asked if there were any themes in the comments, and what we might have learned from the process. Ms. Engel noted that she had touched on examples of themes. The process revealed what points were not made clearly enough, and what required clarification and amplification. Dr. Straus added that the draft had gone through various iterations. Comments were both general and specific. Some were skeptical that science could be done in this area, or they were advocates. By and large, however, there were few global issues mentioned that were in NCCAM's purview. Many comments were helpful in being specific about points that required clarification. Some of these comments were outstanding in that they provided better phrasing of points NCCAM was trying to make in the draft. There was little questioning of goals, however. Ms. Engel pointed out that some comments offered more sensitive ways of saying things. Some comments required us to more accurately portray various practices and practitioners.
Ms. Holloran observed that the definition of CAM was not challenged. Dr. Straus said that a few comments, from both conventional and CAM perspectives, challenged whether NCCAM should exist. Ms. Engel added that there were few responses from the public — only 15.
Dr. Debas asked about the funding balance. Dr. Straus explained that NIH funding for extramural research has grown, while intramural has not. NCCAM currently funds some intramural research projects, with the National Cancer Institute, for example. However, NCCAM is actively recruiting a director of intramural clinical research, and 5 to 8 percent of the budget is projected for intramural research in the coming few years.
Dr. Kahn said that she received a packet from the Alexander Institute a few weeks before the meeting. They were concerned about how they were perceived. She noted that the strategic plan did not include a CAM taxonomy. The categories in Appendix 1 seemed broad enough, but she wanted to know if NCCAM shared a view with certain organizations as to how they are perceived. Ms. Engel explained that the Alexander Institute staff had been looking at an old OAM document not the NCCAM plan. In addition, one thing they clarified in the final version was that some techniques or approaches might cross over into more than one area. Dr. Straus said that issues like this one go back to the fundamental question of who and what is CAM? There are many definitions, and some organizations do not want to be part of it. Some do not perceive themselves as CAM, some think they do not receive proper respect, and others do not want to be considered as conventional medicine. It is impossible to make everyone happy, and he would like the Council to offer advice as they see fit. One consideration is whether there is a need for certain projects in the portfolio, and if certain projects are “CAM-my” enough. Ms. Engel added that the way NCCAM defines a group may be different from how they define themselves. Dr. Straus noted that there are also different schools within various CAM areas.
Dr. Rhoades said that he thought the plan was excellent, in that it embraces an open look at a variety of areas while tying NCCAM to the rest of NIH. Ms. Chung asked what timetable NCCAM would be using for implementing the plan. Dr. Straus said that NCCAM staff members have been looking at the timing. The types of projects NCCAM funds and the priorities in recruitment reflect the plan and plan priorities. Implementation is already ongoing. He believes the activities of NCCAM reflect the plan. But a slightly harder task beyond the day-to-day functioning of NCCAM is long-term planning, like staffing needs and space and communications tools. Drs. Straus and Nahin have on several occasions revised their projections, then talked to Ms. Hoover about space and planning. A more difficult task is analysis of how well NCCAM is succeeding. Dr. Straus wants to shape NCCAM's course rather than passively react to what comes to it. He wants to do not just the best science, but also the most ethical research. NCCAM has a great responsibility to do this. The Center is dealing with treatments that have been in the field for many years and usually lack the pre-clinical safety data that is the norm in conventional medicine. Therefore, NCCAM must build its structure with this responsibility in mind.
Dr. Cantwell praised the plan as being a good, readable document. He thought that one emerging point was that the plan is a structure and that NCCAM is already putting meat on it. There will need to be more openness to the public, however. Straus noted that the process is open. He meets frequently with various organizations; part of what he does routinely is talk to people and get feedback.
Dr. Straus introduced Dr. Stephen Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). In the future, Dr. Straus plans to have other leaders of NIH research present to Council, because collaborations are important to NCCAM.
Dr. Katz explained that NIAMS efforts cover a broad array of diseases and concerns. He focused his presentation on two areas: how organizations work together within NIH, and some potential areas of collaboration. He has been interested in alternative medicine for a number of years and has talked to the medical community about areas of broad interest, such as acupuncture for arthritis. Many NIAMS program announcements have encouraged the chiropractic community to respond. A significant collaboration is in the area of osteoarthritis. Osteoarthritis is caused by the breakdown of cartilage, affecting the hands and weightbearing joints, and can be very disabling. People with osteoarthritis have long been interested in glucosamine and chondroitin. A study of these treatments has been jointly funded by NIAMS and NCCAM and will start soon. This study presents many challenges for the two organizations. The primary outcomes will be alleviation of pain, first, and improvement of function, second. This is a real partnership between the two organizations.
In addition, there are some promising new areas for research. NIAMS has a new director of intramural research, Dr. Peter Lipsky. Dr. Lipsky has long studied Chinese medicine in the areas of lupus and osteoarthritis, which will be of interest to NCCAM. Another significant problem being addressed by NIAMS is low back pain, which is a very challenging area to undertake. NIAMS is looking at opportunities in this area, and will try to identify CAM areas that have promise in this area. Another trial currently being supported addresses conventional and surgical treatments. One cohort in the study is receiving CAM treatments alongside conventional treatments. Also of interest is the area of repetitive motion disorders. NCCAM could join NIAMS on these studies, for there are no proven treatments, and the public is currently accessing many CAM treatments. Another possible project is a public-private partnership to develop a research resource that will generate biomarkers for osteoarthritis. At this point, there are no intermediate markers, and it is hard to assess this area quantitatively. The goal is to determine the markers, and also gauge whether or not current interventions are effective. He would also like to see joint work with NCCAM on bone treatments, such as the effects of different forms of vibration on osteoporosis. The bone is a very dynamic organ, and the public uses many CAM treatments. For skin diseases, Chinese herbal teas are being used to treat atopic dermatitis. Aloe vera is used commonly for skin problems, but there has been little study of it. Electric fields and ultraviolet light have been also used in treating skin disease and he would be interested in studying these. Dr. Katz said that he hoped these examples have illustrated areas for potential interaction between NCCAM and NIAMS.
Dr. Kail asked if there was someone within NIAMS responsible for CAM issues and working proactively. Dr. Katz replied that NIAMS is organized by programs, and the directors for each program look for opportunities for collaboration. They are responsible for looking at CAM issues. The director of bone programs has recommended CAM-related studies, as have others in skin and arthritis programs. He would rather have each program director work in his or her area of specialty to see what can be done with CAM rather than have a CAM specialist. Dr. Meeker noted that pain is a significant problem, and NIH can be confusing in terms of how it addresses this issue. Dr. Katz said that the two leads on pain are in the dental institute and the neurology institute, which may direct projects to other institutes. The concern is not so much overlap as what falls through the cracks.
Dr. Standish asked how likely it is that NIAMS will introduce initiatives that have a CAM interest. For example, there are CAM treatments for atopic dermatitis. Dr. Katz said that NIAMS has already moved in that area in clinical trials. So far, they have looked for feasibility studies that are not geared to NCCAM proposals. However, for example, the glucosamine was their idea first, and they then started interacting with NCCAM. If something like that came up again, NIAMS would work in partnership with NCCAM. Just as NIAMS has expertise in certain areas, NCCAM has expertise with CAM. So it is unlikely NIAMS would do these studies in any way other than a partnership. Dr. Standish noted that he had mentioned challenges with the glucosamine trial, and wondered what those might be. Dr. Katz explained that some issues had to do with a medication that is being used but that does not come from a pharmaceutical company. There was a question about how to obtain the medication and how many arms the study should include. Dr. Straus added that this issue is very technical. The receptiveness of NIAMS has made it a better study. While the two organizations were working out details, they were committed to making it a better scientific study. This is an example of how collaboration made a good idea better.
Dr. Rhoades asked if the NIAMS council has discussed CAM as a topic. Dr. Katz answered that while the larger issue of CAM has not been a council topic, they did discuss the study of glucosamine, and Dr. Straus will talk to the council at their fall meeting. Ms. Holloran asked about the funding of the glucosamine study. Dr. Straus explained that NCCAM had already agreed to fund a four-arm clinical trial. However, an additional arm and ongoing x-rays would improve the study, and NIAMS agreed to pick up some of those costs.
Dr. Nahin introduced Steve Groft, Pharm.D., who in addition to heading the White House Commission on Complementary and Alternative Medicine Policy, was also the first acting director of OAM. Dr. Groft explained that he and his staff have been busy publicizing the existence of the Commission and its activities. The first meeting, in July, was a planning meeting. There is tremendous support for NCCAM in Congress and in the Department of Health and Human Services (DHHS), where everyone thinks highly of NCCAM and its staff. NCCAM has made tremendous strides, the result of much hard work.
The White House Commission is looking at many different areas. One thing the Commission will not do is to establish a research agenda for NCCAM; that is NCCAM's responsibility. The Commission will look at other issues as laid out by the White House executive order. Some of these issues include interactions, coordination, private sector activities, access to and delivery of CAM interventions, reimbursement, training, education, licensure, and certification of CAM practitioners. For example, if there is to be reimbursement of CAM therapies, certification of practitioners will be necessary. The Commission will have an interim report next summer and hopes to complete its work by March of 2002. Current plans are to put the interim report on the web for comment, then shape it, according to comments, into a final report by December 2002. There will be no long-term studies. Instead, the Commission will rely on testimony, published information, and town meetings. The first town meeting is scheduled for September in San Francisco. The White House wants to expand the Commission by five more members, to a total of twenty, and the executive order needed to accomplish that is in the pipeline. Each meeting will look at one of the major issues. Dr. Groft noted that he looks forward to NCCAM Council member participation at town meetings and general meetings. The issues that come before the Commission will shape CAM activities for many years.
Dr. Grimm pointed out that an important issue is the problem of manufacturer cooperation in studying herbal products. Whereas the pharmaceutical industry has incentives to participate in studies, manufacturers of herbal products do not, and they believe they can only lose by participating. Therefore, someone needs to come up with incentives that would gain the cooperation of herbal product companies. Dr. Groft agreed that this is an important issue. The Commission will have some manufacturers at their meetings to discuss this, and will take this up with the FDA. Dr. Kail noted that there were virtually no alternative medicine providers on the Commission, and expressed his hope that the five new members will be CAM practitioners. Dr. Groft said that they probably will be, and that the right balance on the Commission is a concern. But many of those already on the Commission who have M.D.s are also CAM practitioners. Dr. Kail said that there is still a difference between physicians who switch to CAM and those who have only been CAM practitioners. Dr. Groft replied that some of those on the Commission have more depth of experience than is evident at first glance.
Dr. Nahin introduced Mr. Charles Sabatos and Ms. Christine Hollingsworth, who gave an overview of the NCCAM planning and budget process. Mr. Sabatos explained that NCCAM is always taking input into the decision-making process. Those who provide input include the council; medical community; White House; industry; researchers; advocacy groups; DHHS/NIH/ICs; advisory committees; federal agencies; congress; consumers; and CAM practitioners. NCCAM has the following strategic areas to consider: investing in research; training CAM investigators; expanding outreach; facilitating integration; and practicing responsible stewardship. NCCAM plans in order to be proactive; solicit the best ideas from stakeholders and from within NCCAM; give the best ideas a chance to mature; organize and rank the best ideas; tie priorities to a rational budget; and secure buy-in from stakeholders.
Mr. Sabatos detailed the NCCAM priority setting process, in which the Center receives stakeholder input throughout the process. The process begins with a planning retreat, at which staff members review changing policies; identify scientific gaps and new opportunities in broad terms; discuss paradigm-defining and breaking research; review the best ideas from stakeholders; try to think outside box. During the program review process, staff provides input on the development of NCCAM research initiatives and policies; advises the NCCAM director on research priorities; and synchronizes budget development and priority setting. The priority setting process grows out of the planning retreat. Staff members review the initiatives list, and adjust priorities to reflect changes in prevailing scientific and policy issues.
Ms. Hollingsworth explained that there are four phases to the budget process: planning sessions; budget formulation; presentation and Congressional process; and budget execution. In the course of turning plans into program results, many factors interact in a variety of ways. The first part of the budget process is input from stakeholders, which results in the planning and analysis process. This process produces the scientific opportunities and concept clearances that are elements in the NCCAM budget. NIH, DHHS, and the Office of Management and Budget (OMB) review the budget. The resulting version becomes part of the President's budget, which is presented to Congress. The House and Senate each hold hearings as they see fit, then confer to determine the final budget, which is crafted into an appropriations bill. Once the President signs the bill, NCCAM has access to the funds, which are then allocated according to the details of the budget. Ms. Hollingsworth presented a graph illustrating how the planning and budget process spool out over the course of a four-year cycle.
Dr. Straus added that, as part of start-up, NCCAM has been forced to telescope much budget and planning activity into the first year, and the telescoping process has had its costs. There has not been sufficient time for all the background study and planning. But there is flexibility up until the decision is made to fund an activity. For example, the West Nile virus appeared last summer, and NIH is already funding studies, showing that the process is fluid enough to respond to immediate needs of this nature. Similarly, NCCAM may end up having to shuffle priorities at some point. In addition, they cannot count on the remarkable generosity of Congress towards NCCAM lasting indefinitely. If the budget were to cap, that would affect flexibility changes, and NCCAM is bound by the out-year costs of funding commitments. So the process begins with the strategic plan and a sense of global philosophy. Once they know what Congress will give them, NCCAM staff can look at priorities and decide what to fund. Now, with the strategic plan, they have to be more proactive and less reactive, and the Council role becomes more and more important. They cannot fund all of the applications the Council likes.
Ms. Holloran noted that an essential part of any process is monitoring and evaluation, and she would like to see qualitative and quantitative evaluation established as part of NCCAM's process. Mr. Sabatos explained that he is also the evaluation officer. Anything that proceeds from planning must be evaluated. Dr. Straus added that staff has spent much time benchmarking NCCAM in comparison to other institutes, and NCCAM already adopted the software used by some other institutes to help in the benchmarking process. The evaluation process will help NCCAM diversify rather than concentrate research efforts, and will keep the organization operating according to the strategic plan. Dr. Straus added that evaluation of published studies takes a long time, since most studies are multi-year. However, NCCAM is prepared for this work, and welcomes feedback from the scientific community as to what is effective and what is not. Dr. Nahin added that part of evaluation is determining whether the researchers are living up to their commitments. Some studies change; NCCAM program staff must monitor the studies to make sure they do not get too far away from the original, approved project. Dr. Schlitz asked if there are efforts to develop new research strategies. Dr. Straus explained that there are philosophical issues in terms of trying to develop new designs. Some treatments are difficult to control for. Dr. Nahin said that there is a line in the strategic plan about how observational trials might be more worthwhile than double-blind under certain circumstances. Staff will continue to examine methodologies and refinements of methodologies to best fit the needs of CAM studies.
Dr. Macintosh asked about institutional review boards, or IRBs. Dr. Straus explained that NCCAM does not conduct those reviews. All NIH clinical studies are reviewed by IRBs, and larger studies are monitored by data safety and monitoring boards. In general, these bodies are concerned about ethical issues; program officers keep in touch with investigators about these issues. There are times when program staff members go back to investigators with concerns. Dr. Macintosh said that she was interested in the notion that IRBs will have more input than in past in suggesting research protocols. Dr. Straus noted that NIH has always been a place for policy discussions. IRB procedures have been strengthened in certain areas, and there is a greater mandate for certain types of documentation. But IRB members, who are volunteers, have complained that they are overtasked. To reduce this burden “just-in-time” IRB approval has been implemented DHHS-wide. Formerly, an IRB had to approve each clinical protocol before it was reviewd by NIH. Now this approval is not required until just before NIH funds the grant. Then the investigator gets IRB approval before receiving funding. Dr. Nahin pointed out that this places more of a burden on NIH staff to ensure that projects do not change substantially through the IRB. Dr. Debas commented that it would be a mistake for an IRB to recommend study design. Dr. Straus agreed that the responsibility of the IRBs is to review ethics, not science.
After breaking for lunch, the Council heard comments from the public. The first speaker was Mr. William Offitt, a small business consultant who has gone through the NIH Small Business Innovative Research (SBIR) process. He had many concerns with the process. The scientific review process is new to him in many respects, and he sees the use of human subjects as a red flag. He asked how the research process will be different at NCCAM, and if animal testing will be necessary in all CAM research studies. He observed that all of the major centers seem concerned with it. He thought that recommendations from a conference with the Heart, Lung, and Blood institute should be shared with the Council. The conference cited a study in Germany in which CAM products were standardized; there is a much higher rate of CAM use in Germany.
The next speaker was Mr. Maury Silverman. He commended NCCAM for the type of research the Center is doing, as well as the research potential. He would like to see the next NIH director have a strong background in clinical research. NCCAM's clinical research is very important, for the Center can and does exert leadership and build bridges to other institutes. This is positive, because their findings will go out to the medical community. NCCAM's work reflects back on the original NIH mandate to improve the health of the American citizen. NCCAM needs to look at problems of delivery systems in American medicine. NCCAM could be instrumental in the foundation of getting many therapies online. Mr. Silverman is concerned with the high prevalence of stroke and brain injury among the elderly. He would love to see NCCAM look for proposals on hyperbaric oxygen, for the best results in healing stroke and brain injury come from hyperbaric oxygen. He attended a conference a few years ago where people were looking to study hyperbaric oxygen and acute stroke. The problem in the delivery system in that people are sometimes not treated. There is much talk about better access to healthcare. NCCAM already has a track record of building bridges, and in this area has an opportunity to do tremendous good by funding clinical research that reaches further than most other research. He hopes NCCAM will seize the opportunity and look in different directions to solve problems.
The next speaker, Ms. Jane Twitmyer, introduced herself as a consumer of alternative medicine. She said that NCCAM has a unique opportunity to affect the lives of many people. In the area of addiction, many clinicians are doing good work, but not all of their work is finding its way into the literature. There is high recidivism in addiction. The old scientific assumption is that the connections in the brain are set, but new information indicates otherwise. A new approach to treatment will consider that time is a fluid variable. We still look at addiction as having an element of weak will. We cannot neglect research of the physical interfaces of addition, nutrition, and other elements. She therefore would like NCCAM to consider doing work in the area of addiction, and would be like to discuss this further with the Center. As there is now a concerted effort to deal with this problem, it would be a good time for NCCAM to join in.
Mr. Richard Pavek addressed the topic of touch therapies, from the laying on of hands to magnetic and mechanical therapies. A line in the strategic plan says this field has not been proven effective. The medical profession tends to be antagonistic to this area and views it as problematic. Mr. Pavek would like to see basic science studies in this regard. Studies thus far have all been done by skeptics, and the medical profession has even advised against the laying on of hands. He has spent considerable effort looking for flaws in one of these studies, which he has redone, proving that the basic physics work. There is a need for more basic science in physics laboratories. This kind of work must be studied.
The next speaker was Ms. Beth Clay, who is with the Government Reform Committee in the U.S. House of Representatives and who also worked in OAM some years ago. She questions the notion that the dietary supplement industry does not want to do research. NCCAM should find ways to do specific research on specific therapies with specific supplements, and be careful about making broad statements about how this industry does not want to do research. She also has an issue regarding the charter for NCCAM. The charge was to build on their work year upon year. Field investigations and the challenges involved were discussed some time ago, but it is unclear what happened with that. Is there a report on evaluating it? She also agrees with Dr. Straus that there are not sufficient fact sheets of sufficient quality. This should be fixed soon so the public can go to the NCCAM web site and learn about what to do and where to go. She is hoping their budget for next year will be the $100 million mentioned earlier. She wants to see much of that money used on areas very specific to CAM. Conversations are beginning in regard to licensing practitioners. When that happens, NCCAM will need to have the research to back up the criteria. She wants them to be bold.
Dr. Sandra McLanahan was the final speaker from the public. She has worked with Dr. Dean Ornish. As she sees it, CAM is following the same evolution as natural childbirth, which went from being strange to being the standard option. She believes that CAM will follow the same path. Elements of alternative medicine that have been taught separately are coming together. A hospital should offer all the health-related information available. We should think about how much health we can create with all the money that goes into research. Less than 1 percent of the NIH budget goes to NCCAM. We should think about why people get sick. We get sick because of cigarettes, alcohol, bad diet, stress, and lack of exercise. She would like to see NCCAM focus on these. Dr. Ornish's program is being offered and even run by Blue Cross/Blue Shield in some places. They have found that teaching patients to relax and be healthy is more cost effective than operating on them. The patients feel better, look better, and live longer. We need to bring these issues into end-of-life care. She would like to see NCCAM emphasize prevention. If NIH devoted 95 percent of its resources to prevention, we could have a significant shift in the nation's health.
Dr. Goertz presented a new project concept titled the “Prevention of Onset, Progression, and Disability of Osteoarthritis” (OA). OA is the most common form of arthritis, occurring late in life and commonly affecting the hands and weight-bearing joints. It is characterized by pain, deformity, enlargement of the joints, and limitation of motion. NCCAM is already supporting research on two CAM interventions to treat OA symptoms: acupuncture, and glucosamine alone or in conjunction with chondroitin. There are other CAM interventions that have been under-researched, however. The proposed initiative would explore the entire repertoire of CAM strategies used as OA treatments in the United States. The research would identify which interventions are safe and effective, and which are not, allowing patients to make more informed choices. The initiative will be funded jointly with NIAMS under R01 and R21 grants.
Dr. Cantwell asked whether these grants would be to study prevention alone or in conjunction with treatment. Dr. Goertz explained that the initiative does not dictate the proportion; it involves treatment as well as prevention. Dr. Pardes stated his approval of the collaborative aspect and the project as a whole. Dr. Standish agreed, and asked how OA came to be identified as a high priority. Dr. Goertz explained that this is a huge public health problem, and it will become more of one as the baby boomers age. In addition, OA can be very debilitating, yet there are no adequate therapies at this point. Dr. Standish noted that the initiative also mentioned manual manipulation, magnet therapies, and SAM-e. Dr. Nahin said that NIAMS has found that these are the most-used alternative therapies for OA. Dr. Kaptchuk suggested listing other therapies as well, such as awareness therapies.
Dr. Meeker asked if there would be a preference for biological markers versus outcomes. Dr. Goertz said there would be no a priori priorities. Dr. Macintosh noted that we do not yet know whether or not OA can be cured. Dr. Kahn asked Dr. Meeker if he had a preference between biomarkers or outcomes. He said that he would like patient-oriented outcomes. He also noted that OA is not defined, or not defined well, in the concept. He asked if this would also cover basic science studies. Dr. Goertz said that they would look at mechanism-of-action elements as well as the effects on humans. Dr. Nahin added that NIAMS would primarily do that. Dr. Pardes suggested that the Institutes and NCCAM consider which of the many therapies would be best to fund. As far as outcomes between bio-indicators and people's responses, he would be interested in both. Ms. Holloran asked what criteria would be used to determine what are good applications. Dr. Goertz said that the study section that reviews the application would consider every hypothesis that comes in. Ms. Holloran asked if there is preliminary data. Dr. Straus explained that a hypothesis is based on background data. When applications for this project are received, they will be peer reviewed by experts who will know how to evaluate hypotheses and study design. Ms. Holloran asked how something that has been demonstrated is evaluated. Dr. Goertz explained that they use certain criteria for evaluation; applicants are expected to address their specific aims, what they plan to do, and how that will support the project goals. The R21 program is designed to provide a forum for developmental research where not much has been done yet.
Dr. Debas suggested that NCCAM and the Institutes could be overwhelmed in this large topic area. He suggested that perhaps they support preliminary studies. Dr. Goertz explained that these grants are not intended for large-scale undertakings; they only cover preliminary studies. Dr. Kahn noted that there are skilled CAM practitioners who have good ideas but who have no idea how to partner with a clinical researcher. They keep turning to NCCAM to learn how to find each other. She wondered if there is a way to address this. Dr. Straus pointed out that investigators have been succeeding in this area. Applications are coming in now that reflect such partnerships. Peer reviewers will examine applications from a CAM perspective and other experts will examine other aspects of the proposal. Dr. Kail noted that more and more groups are considering submitting proposals to NCCAM, and he believes that NCCAM is doing what it needs to do to bring these people in.
Dr. Pardes motioned for approval. The concept passed unanimously.
Dr. Standish asked how the Center is conceptualizing these proposals so that there is an overview. Dr. Nahin said that the Council is generating some ideas, and Dr. Straus said that his discussions with other directors carry considerable weight.
Dr. Morgan Jackson of NCCAM presented the second new concept for review, “Epidemiologic Studies of CAM in Racial and Ethnic Minority Populations.” This project is related to the DHHS initiative to eliminate racial and ethnic disparities in health care. Some CAM modalities practiced in this country have arisen from the traditional healing practices of other nations. Others have evolved or have been adapted to work within the context of the U.S. majority culture. These practices and systems are not well-documented within their native communities, nor are they understood within the context of our community. Therefore, studies of minority populations will help improve understanding of the extent of CAM use by various populations, the variations in use, and the conditions for which CAM is used. This initiative would advance the understanding of CAM use by racial and ethnic minorities, which would in turn provide NCCAM with the information it needs to determine its role in implementing the DHHS initiative. The initiative will provide support for surveys to collect data relevant to this goal.
Dr. Schlitz asked about how grantees would collaborate if they are initially submitting individual proposals. Dr. Jackson explained that the chosen funding mechanism allows heavy federal involvement, which would allow NCCAM to help match up potential partners. NCCAM will only fund proposals of sufficient excellence. Dr. Schlitz asked if applicants would modify their proposals in response to NCCAM's suggestions. Dr. Jackson said that the proposal will be written so that applicants will understand that this will occur. Dr. Kail said that this seemed like a difficult project, possibly an intramural project. They could end up with 25 ways to ask the same question. Therefore, they should be more specific about what information they want, instead of having people submit applications first. Otherwise, NCCAM could receive conflicting information. Dr. Jackson explained that he is not sure that a single form would address all modes of CAM. So he would like to see standardizing those portions of a survey that can be standardized, and they would expect a high degree of specificity.
Dr. Kaptchuk said that it is nice to see the extension of CAM to patient populations other than just rich whites or ethnic groups, and he would like to see more of this orientation. Mr. Williams added that his concern is that there is a need to prime the pump. Some populations distrust the federal government and therefore might not participate. This can be a very frustrating thing. He is optimistic, yet still worried that there will not be a good response. Dr. Nahin explained that Dr. Jackson will be a conduit to minority populations and leaders. Dr. Grimm cautioned that they should be careful about sampling. Geographic location might be as important as ethnicity. Dr. Jackson said that they are hoping that there may be overlap in the focus of individual applications that would bring coherence among geographical populations. Dr. Straus added that the White House Commission may ultimately affect access to CAM care. So there is a need to have some sense of what people are already using and how. This translates into baseline information, which is a first step. It would not be right to assume that previous studies are representative. Ms. Holloran asked if the Census Bureau collected useful information along these lines; Dr. Straus said that they are not. Dr. Pardes suggested that the ability of those doing the research be a criteria in evaluation. Dr. Rhoades added that the difficulties noted are magnified many fold in the case of Native Americans, which is both heterogenous and standoffish about dealing with the federal government. Some will not want to talk about traditional modalities—they may feel sworn to secrecy. A motion was made to accept the concept, and the council voted unanimously to pass it.
Dr. Mary Ann Richardson presented the third new concept, for clinical trials of phytoestrogens for breast cancer. Because of its association with breast cancer, women in the United States often avoid taking estrogen replacement therapy (ERT) even though it has many benefits. Instead, many women turn to herbs and vitamins without knowing their effects. It is difficult to determine the effects of some of these substances, and some are dose dependent. NCCAM is already sponsoring a study on soy isoflavones, looking at the effects on breast and bone health. This initiative would support Phase II trials to assess the impact of phytoestrogen supplements on the health of women after a breast cancer diagnosis. Emphasis will be on dosing trials, and preference will be given to clinical trials that include laboratory studies. The primary objective is to evaluate the role of phytoestrogens alone versus diet, standard ERT, ERT with phytoestrogens, and/or multifaceted CAM interventions. Secondary objectives could include assessment of the impact of phytoestrogens on estrogen-responsive tissues, and determination of bioavailability, intermediate outcomes, and toxicity of phytoestrogen supplements.
Dr. Standish noted that there is a dearth of useful scientific information in this area. Ms. Holloran had questions about the appropriateness of the approach. Women want to know what to do when faced with breast cancer and estrogen issues. They want to know if they should go to a CAM practitioner and get herbs, or consult a Chinese medicine practitioner to get herbs and acupuncture. NCCAM should be sensitive to responding to the public; she questioned the utility of doing a study like this. Dr. Richardson explained that this is not a single substance study and it specifically includes the option of multiple combinations. The study would also examine efficacy in reducing symptoms. This study would try to look at phytoestrogens in various forms and see how they affect individuals. Dr. Standish suggested that one of biggest challenges is the tendency for people to take these matters into their own hands. Dr. Kail added that what we do not know matters. Dr. Richardson said that NCCAM is trying to collaborate and fund some substantial RO1s with a solid lab component. Dr. Olness said that there seemed to be intrinsic problems with the study as written, for these trials would use women who already had a breast cancer diagnosis. The concept passed on vote, with one vote in opposition. Dr. Macintosh explained that her opposition was that the study seems too focused on phytoestrogens as drugs. A study of what women are using should be worded differently. Dr. Nahin said that there will be language like that in the final RFA.
Dr. Goertz presented a new project concept entitled “Biology of Acupuncture.” Each year, over one million people receive acupuncture in the United States. Practitioners range from physicians to traditional Chinese medicine healers. Acupuncture is based on the premise that energy, called Qi, travels along prescribed pathways in the body, maintaining good health. Acupuncture techniques stimulate specific points on the body in order to regulate this energy flow. Acupuncture is used to treat conditions such as pain, nausea, headache, heart disease, and asthma, among others. Studies addressing biological explanations for acupuncture's treatment effects have established that the treatment stimulates the release of endogenous opioids, among other effects. This proposal would invite applications to elucidate the basic biological mechanisms and processes underlying acupuncture. The goal of the initiative is to promote innovative research along these lines, facilitating improved clinical trials that could lead to improved clinical applications. The research would fill gaps in the knowledge base.
Mr. Williams observed that other concepts have higher levels of funding, and the amount suggested seemed low for a study that comes close to integrating conventional and CAM therapies. Dr. Goertz said that some aspects of study could be extremely expensive. Dr. Straus added that in looking at the entire NCCAM portfolio, they found they were investing more in acupuncture than in any other single modality. So the implications of this study would be enormous. It is important to note that this study will pull in three or four other institutes, which will add funding. Dr. Kail also questioned the funding level and suggested that they increase the funding. He was also concerned about evidence that the neurobiological event of acupuncture is secondary to changes in energy. Dr. Pardes wanted to relate this to an earlier request for more modality-based study. Ms. Holloran noted that the modality would be traditional Chinese medicine. Dr. Pardes also asked about the difference between an electrical event and a neurobiological event. Dr. Kail explained that the electrical event could create the neurobiological event.
Dr. Debas said that this could be an important initiative that would do a lot for the whole field. Dr. Kahn said that the proposal seemed to over-reach, with too much in a single initiative. She suggested they separate the proposal into at least two initiatives. Chinese medicine would define events a certain way. It is important to know if they want to talk about meridians, as in Chinese medicine, or western biomarkers. Dr. Goertz said that they would like both perspectives. Dr. Meeker wondered if the proposal could be expanded to cover other areas, such as hands-on therapies. Dr. Katpchuk suggested that they change the term to “practitioners of East Asian medicine” instead of referring to “traditional Chinese medicine.” These practitioners are sometimes treated in a racist manner, and it is important to be culturally sensitive. Dr. Macintosh also wanted to split the concept into two studies. She noted that the definition of acupuncture is problematic here. She felt that the term referred to a treatment within a whole system of medicine, but the proposal broke it out as a procedure. There is a difference between “acupuncture” and inserting needles into certain points of body. Dr. Goertz said that in this case, the definition depends on the research question asked; she would like to leave the proposal broad. Dr. Pardes said that acupuncture has been around for some time, and he wanted to get the best applications and see how they elaborate on the ideas in the initiative. He did not want to split the proposal.
Dr. Schlitz liked the initiative, but she felt that it did not reflect that acupuncture comes from a different base of belief and practice. Biology is “boxed” and she would like NCCAM to acknowledge that it is not only way that we can understand healing. Dr. Cantwell asked Dr. Goertz to add a few words about energy, which NCCAM has been shy about addressing so far. This would be a good place to start, in that they could get studies back to measure Qi. Dr. Straus said that they will look at hypotheses, then in subsequent trials look at correlates with patient improvement. If it were possible to measure and reproduce Qi, it could be built upon in later studies. This proposal makes no assumptions. Dr. Kaptchuk said that there is a tendency on the Council to either put proposals into our own ideological belief systems or declare it not a good proposal. If acupuncture is going to advance, or CAM in general, there may be value in making this study. They should let investigators come in with their ideas. Qi is important, but the Council should not wave banners of belief. Even if it is too broad and general, the initiative works. Before voting, Dr. Kahn wanted to know if the Council would be interested in separating the initiative into two issues, of acupuncture both in its own framework and separately. Dr. Nahin explained that NCCAM was trying to partner with the rest of NIH. There was concern about marginalizing NCCAM initiatives by making them too narrow. Broad concept proposals are better for collaboration and for increased buy-in from other institutes to CAM in general. Dr. Standish said that two initiatives would be inefficient as well. Dr. Kahn observed that if the motive for keeping the initiative broad is political, that will discourage some investigators from applying. She was also concerned about the influence other partner institutes have when they participate. Dr. Nahin said that they would not take out things, but could add or elaborate. Each institute picks up applications that address their own areas of interest. On the vote, there were two abstentions, with all others voting to pass.
The next concept presented for review was “NCCAM Institutional Research Training Program (T32) for Minority Researchers.” Dr. Jackson explained that to deal with the well-documented underrepresentation of racial and ethnic minority investigators, NCCAM seeks to help develop a cohort of minority scientists capable of investigating CAM. At the same time, NCCAM hopes to enhance the ability of minority institutions and minority-serving institutions to support CAM research. The proposed program would attract students in their developmental stages, increase their awareness of CAM research, and encourage them to pursue research careers in this area. Applications would be limited to minority institutions and minority-serving institutions. The grantee institution must identify among its own faculty or that of a collaborating institution appropriately trained and experienced CAM researchers capable of mentoring trainees.
Dr. Kail suggested that the dearth of qualified CAM researchers made that requirement a difficult one to meet. Dr. Jackson said that perhaps a focused individual, such as a CAM practitioner, would be better than a CAM researcher. Dr. Grimm asked for the definition of a “minority-serving institution.” Dr. Jackson said that this is becoming increasingly difficult to define, but that other NIH institutes use a definition of 50 percent or greater minority students at the school. There is a problem in that Hispanic students are not concentrated at certain schools the way African American students often are. The thought was that the review committee could determine whether the applying institution shows a commitment to the education of minority students. Dr. Pardes suggested they be more encompassing, for this definition might be seen as too restrictive, excluding students and good centers. He would modify the criteria to make it more facilitative of a variety of applications. Dr. Jackson said that a few institutions would be considered Hispanic-serving health professions schools. The challenge is in providing opportunities for minority institutions to have a place at the table. The criteria allow for collaboration between minority institutions and others institutions, where the latter would provide experience in this area to help bring minority institutions along. They will let each applicant institution make the case for its own record. Dr. Pardes would prefer a clear record of intent and action in training minority students.
Dr. Straus asked about participation by African Americans. Dr. Jackson said that they could turn to the historically black colleges, among others. They do not have demographic information on the matriculation rates for all American institutions. Some are obvious in their commitment to train minority students, and some are not. Dr. Straus suggested that the criteria be clear in advance so that unqualified institutions do not apply. Ms. Holloran asked if they could separate the initiative into two: one to train minority researchers anywhere, and one focused on institutional capacity and development. Dr. Jackson said that this would require an administrative decision. Dr. West added that NIH has a series of pre- and post-doctoral fellowships for minorities, and NCCAM already had one. Ms. Holloran suggested separating the institutional focus from the researcher focus.
Mr. Williams wondered if Supreme Court decisions on affirmative action might preclude them from giving money to minority students at a non-minority school. Ms. Chung asked how they would define an Asian American university. Dr. Jackson said that it would be problematic. While African Americans and Hispanics are easy to track, other minority groups are not. Dr. Kail suggested that they put together a think tank of CAM practitioners and experts to advise researchers. Dr. Pardes observed that with another mechanism in place to help individual students, this is really an institutional project. He would like to let the institutions show their own record on their minority recruitment and support efforts.
Dr. Straus noted that everyone seemed to think the proposal was a good idea, and said that NCCAM staff would adjust the wording to address Council issues. Dr. Jackson added that he would be happy to talk with Council members about language changes or preferences. Dr. Cantwell noted that the degrees listed in the proposal were all allopathic. Dr. Jackson explained that those were examples, not an exhaustive list, and he would change wording. Dr. Straus said that the mentor should be a seasoned researcher, regardless of title. Dr. Meeker cautioned that NCCAM was too physician-oriented and should be more specific in including others. Dr. Schlitz asked if the proposal should be put back on the table at next session after a rewrite, but Dr. Jackson thought that the comments would not require substantial changes. The differences seemed to be of degree more than anything. Dr. Nahin asked each Council member to express his or her concerns, then vote with the understanding that the concerns would be addressed in the final document. After going around the room, most Council members had no additional comments. Mr. Williams asked that they define minority institution and minority-serving institution, and Dr. Cantwell asked that they specifically expand the degrees allowed. In the vote, there was one abstention, and all others voted in favor.
Dr. Richardson presented the final proposed initiative, entitled “Palliative CAM for Advanced Cancer and HIV/AIDS.” The goal of palliative care is to provide for the various needs of terminally ill patients and their families. The initiative was developed in response to calls Dr. Richardson has gotten from people searching for palliative care. Many terminally ill individuals with cancer and/or HIV/AIDS use CAM therapies that have yet to be investigated. The initiative would expand the range of current treatment options by supporting developmental and Phase I-II clinical trials that would lead to the development of new therapeutic approaches. Ultimately, terminally ill patients might benefit from a broader range of effective treatments.
Dr. Kail suggested that the initiative be retitled from “palliative” to “end-of-life care,” and Dr. Richardson agreed. Dr. Standish asked if there was also a subagenda to investigate CAM treatments in the cancer realm, to see if the treatments would be useful in increasing the length of life and reversing the progression of disease. Dr. Straus noted that NCCAM has an important responsibility to identify novel primary therapies, but that is not the essence of this initiative. A call for proposals that could also focus on lengthening life and reversing disease would confuse the investigator and dilute the focus of the study by dissipating resources. The initiative focus is on people who are going to die and ways to make them feel better. End-of-life care is a complex area. Dr. Standish replied that she agreed, but would still like to see an initiative examining cancer and HIV/AIDS therapies. Dr. Nahin said that such a proposal is likely at the next council. Dr. Cantwell noted that most people at the end-of-life turn to spiritual care. His institute works with guided imagery that can be applied in spiritual ways. At this point of life, spiritual discovery is important. Ms. Holloran asked how they would measure study results. Dr. Richardson said that they would look at pain and side effects, among other elements. The initiative passed unanimously.
Before adjourning for the day, Council noted the difference between the ways CAM is used in real practice and the way it is applied in clinical trials. Dr. Macintosh expressed concern that there are many ethical issues in withholding a proven treatment. Dr. Olness noted that there are countries where cancer is addressed with CAM therapies only. Dr. Schlitz observed that there are thousands of case studies of full remissions based on only CAM treatments. Dr. Straus noted that the Gonzalez regimen has many cases of cancer remission, and that the regimen is being studied at Colombia University. Even if it proves ineffective, there will always be people who choose that regimen for various reasons. When NCCAM asks for data, many practitioners do not provide it. So part of NCCAM's work is to move from practitioners saying that they think they have a solution to getting reasonable information that backs up their statements in a reliable way.
The meeting adjourned at 5:30 p.m.
CLOSED SESSION - AUGUST 29, 2000
At 8:30 a.m. on August 29, 2000, Dr. Nahin called the meeting to order.
The session was closed for per-review of applications. A total of 74 applications were assigned to NCCAM. Of these, 73 were reviewed by NCCAM with one was 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 65 applications requesting $201,656,771 in total costs. Council recommended 41 new research grant applications with a total cost of $111,452,368.
There being no further business, the meeting was adjourned at noon on Tuesday, August 29, 2000. The next meeting is scheduled for November 13-14.
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
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.