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Minutes of the Second Meeting - January 24-25, 2000
National Advisory Council for Complementary and Alternative Medicine (NACCAM)
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On this page The National Advisory Council for Complementary and Alternative Medicine (NACCAM) convened at 8:30 a.m. on January 24, 2000 at the National Institutes of Health (NIH) Neuroscience Office Building in Rockville, Maryland. Stephen Straus, M.D., Chair, called the meeting to order. The meeting was open to the public from 8:30 a.m. until 12:45 p.m. on January 24. The meeting was closed to the public on January 24 from 1:45 p.m. until 6 p.m. as provided in Sections 552b(c)(4) and 552b(c)(6), Title 5 U.S. Code, and section 10(d) of Public law 92-463, for the review, discussion, and evaluation of grant applications and related information. The meeting was reopened on January 25 from 8:30 a.m., until noon. Council Members Present (1)
Council Memebers Absent
NIH Staff Members
DAY ONE - JANUARY 24, 2000I. Call to Order and Meeting ProceduresThe meeting was called to order at 8:30 a.m. by Dr. Stephen Straus, Director of NCCAM, who turned the proceedings over to Richard Nahin, Ph.D., Executive Secretary NCCAM. Dr. Nahin discussed the procedures NCCAM council members must abide by and addressed the requirements of working under federal laws regarding open and closed sessions. The morning session was to be open to the public, while the afternoon 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 at the end of the second morning of the meeting. Dr. Nahin then gave a brief overview of the conference's agenda, including concept clearance and a presentation of the complementary and alternative medicine (CAM) citation index (CCI). II. Introduction of MembersCouncil members introduced themselves and stated their areas of expertise. III. Future Meeting DatesDr. Nahin reminded members that the dates for the next council meeting are May 8 and 9; the following meeting will be August 28 and 29. NCCAM staff will schedule dates for Fiscal Year 2001. While there is no scheduled meeting for November, staff will add one if necessary. IV. Review of Confidentiality and Conflict of InterestDr. 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; and 3) there is even an appearance of conflict stemming from participation of a family member or associate of the Council 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 are present, Dr. Nahin said, the Council member is to withdraw from the discussion to prevent the proceedings from having an appearance of bias. Dr. Nahin also instructed members to refrain from discussing meeting topics outside the forum of NACCAM meetings. The review process should not be discussed with applicants; to do so would be a disservice to them and other applicants. If Council members are contacted by applicants, they should refer the applicants to NCCAM staff. Furthermore, Council members must not keep any materials distributed in a closed session. These materials must be left with NCCAM staff since they contained confidential information. V. Introductory RemarksDr. Ruth Kirchstein, Acting Director of NIH, arrived at the meeting and spoke. Back when the organization was still an office (Office of Alternative Medicine, or OAM), Dr. Kirchstein attended a number of the OAM Council meetings and was involved in most of OAM's early activities. She observed that the organization has come a long way since then, and it is a pleasure to have it organized and moving along. NIH as a whole is in a transition period. She has been acting director since December 1999 and has been preparing for the congressional appropriations process. Congress and the administration have treated NIH extremely well over the last two years. Dr. Kirchstein said she believes NIH has used and will use the funds of the American people extremely well. The current state of science is exciting, and the opportunities to be translated into medical advances are great. It is incumbent on all parties, including the NCCAM council and staff, to make sure they have appropriate answers to indicate the priorities for using these funds appropriately and advance the public's wishes for priorities. She believes NIH and NCCAM have worked in that direction. About a year ago, NIH convened a group of patient advocates to come and help with decision-making. Each NIH institute now has a public liaison representative. This has worked extremely well. A mandated database of all clinical trials was scheduled to launch in early February 2000. The database would include not only NIH and other Federal clinical trials, but also private clinical trials. NIH is responding to the public in many ways and will continue doing so. Dr. Kirchstein added that she is open to listening to all suggestions and has an open door policy. In response to Council questions, Dr. Kirchstein noted that the list of clinical trials was to include those in the area of alternative medicine, although it was possible some would be missed at first. In terms of international trials, the NIH database would focus on U.S.-based trials, which is a formidable task in and of itself. Dr. Kirchstein added that an area of current emphasis at NIH is the disparity in health status of individuals in different strata in society — the poor, people with disabilities, minorities, etc. She planned to ask NIH offices for a strategic plan dealing with these health disparities; each institute would prepare its own strategic plan. On the topic of bringing more credibility to CAM practitioners and scientists, and encouraging work between them and conventional practitioners, Dr. Kirchstein observed that it seems to be happening on its own. Many hospitals are now applying a holistic approach to patient care. More medical professionals recognize the need to address all aspects health care. NIH is addressing this. She noted that when NCCAM was still OAM, the other NIH Institutes were spending several times the annual OAM budget on their own CAM activities. VI. Statement of UnderstandingThe revised Statement of Understanding was discussed, since there was no quorum to approve or disapprove it at the August meeting. Council suggested that the Statement quote the Congressional mandate establishing NCCAM and that such language be used wherever applicable, instead of paraphrasing. Regarding Section 4, which addresses expedited awards on meritorious applications, the issue of whether Council understood NCCAM priorities was raised. Dr. Nahin explained that the Statement does not define priorities, but rather sets paradigms for the peer review process itself. Under the expedited review process, any Council member can request full discussion on any application. Applications are only expedited when all Council members agree. Dr. Straus added that the process would become clearer once the Council had gone through it. In brief, independent scientists determine the score during the initial peer-review; the Council assists in deciding the relative importance of an application that has been determined to be "good science." In this way, scientific merit and NCCAM priorities are simultaneously considered in assessing programmatic priorities. Dr. Nahin noted that the process and priorities will evolve over time. The question was asked as to who reviews the applications during the initial peer- review, and what their qualifications regarding complementary and alternative medicine (CAM) are. Dr. Nahin explained that NIH seeks individuals with appropriate CAM expertise. The NIH Center for Scientific Review includes ad hoc reviewers in a study section as appropriate, in consultation with NCCAM staff. One problem is that the summary statement system doesn't recognize all of the standard CAM practitioner abbreviations (e.g., L.Ac., N.D, D.C., etc.); NIH is working to add these to the system. In addition, ad hoc advisors are not always identified in the study section roster. Some Council members had been discussing the Statement of Understanding and had no sense of how restrictive it will be. Dr. Nahin explained that the Statement must be in the official record as the contract between the Council and NCCAM. He offered to make adjustments, but emphasized the need for a vote on the document at this meeting. He suggested that the vote occur later, with the understanding that comments would be incorporated. It was suggested that the title of the document be changed to "Statement of Understanding Concerning Peer Review", and Dr. Nahin agreed to make the change. VII. Director's Report and Overview of NCCAM's Research StrategyDr. Straus discussed the first year of NCCAM in an address accompanied by slides. In discussing public health opportunities, Dr. Straus noted that CAM practices are increasingly available to Americans. Some CAM practices may sustain and improve health, while some may not; the public deserves definitive guidance as to which practices are safe and effective. The existing body of evidence may be entirely anecdotal or unrecorded, consisting of retrospective and biased case reviews; foreign language books and periodicals; limited circulation monographs; proprietary information; studies that are small, non-randomized, and/or unblinded; evidence-based reviews and meta-analyses. It is important to examine how to move the data beyond this state. Dr. Straus emphasized that NCCAM authorization carried with it a number of obligations, including the following tasks:
Before discussing his own background, Dr. Straus acknowledged NCCAM's first "heroes" including William Harlan, M.D., Dr. Richard Nahin, Mr. Patrick Williams, and Mr. Douglas Hussey. Dr. Straus said that during his 28 years as a practicing physician who cared for patients on a daily basis, it became clear to him that despite helpful advances, science has not addressed all patient needs. Access to a more complete range of options became important to him. This is where NCCAM has a great opportunity to affect public health. He has come up to speed with help from the following: 1) briefings by key NIH leaders, including Dr. Harlan, Dr. Kirschstein, and IC directors and administrators; 2) congressional visits; 3) sessions of the Trans-Agency CAM Coordinating Committee and the Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM); 4) visits with leading CAM investigators and advocates; 5) introductory calls to Council members; 6) extremely patient training from NCCAM colleagues; and 7) a review of the NCCAM research portfolio. Dr. Straus stated that the NCCAM mission is to prevent and alleviate human suffering through rigorous research on the safety and effectiveness of CAM modalities, and through research training, and information dissemination for healthcare providers and consumers. He went on to say that NCCAM's strategic areas include: 1) investing in research; 2) training CAM investigators; 3) expanding outreach; 4) facilitating integration; and 5) practicing responsible stewardship. In setting research priorities, NCCAM considers: 1) the most credible preliminary data; 2) the ability to learn new science; 3) use by the U.S. public; 4) public health impact; 5) adequate patient volunteers; 6) availability of methodological expertise; and 7) study cost. There is a hierarchy of evidence, progressing from anecdotes through case studies, observational studies, uncontrolled trials, small random controlled trials (RCTs) and systematic reviews to reach the gold standard of clinical research, large RCTs. The following are key principles of CAM research: 1) use the same designs and outcome instruments as for definitive studies of conventional practices; 2) randomized, double-blind controlled trials are the "gold standard"but some modalities cannot be blinded; 3) studies of whole CAM "systems" require creativity and flexibility; and 4) CAM experts and patient advocates should be included in study design and oversight. Dr. Straus then began an overview of the NCCAM Division of Extramural Research, Training and Review (DERTR). DERTR has four areas of primary responsibility: 1) research program development; 2) international and traditional health; 3) research training and career development; and 4) scientific review. Program areas within DERTR include: 1) investigator- initiated research; 2) centers; 3) developmental grants; 4) phase III clinical trials; and 5) meeting and conference support. The CAM centers program focuses on: 1) categorical disease/condition areas; 2) Phase I and II studies leading to RCTs; 3) exploring mechanisms of action; 4) training and career development; 5) integration of CAM practices; and 6) community outreach and education. Dr. Straus noted that this portfolio is a compromise; NCCAM should expand in areas that take progressively more advantage of the CAM research centers' strengths and expertise. The future portfolio will afford broader expertise, beyond those of the nine centers. The nine current specialized CAM research centers around the country include:
Dr. Straus presented a graphic of NCCAM research mechanism emphasis. This schematic showed budgets relative to 1998; the budget has increased 3 ½ fold during the last three fiscal years. There has been carryover money from Fiscal Year 1999, which is a unique, onetime opportunity; NCCAM will invest this money in the research portfolio. Dr. Straus explained the use of systematic reviews in the NCCAM decision- making process. Systematic reviews allow for a structured appraisal of data regarding a given CAM modality including: 1) a well-formulated research question; 2) predetermined criteria for data quality; 3) a comprehensive literature review; 4) an unbiased selection and abstraction process; 5) the critical appraisal of data; and 6) a synthesis of the data. This process expands our understanding of all the available literature. In selecting materials for clinical trials, as a rule, NCCAM finds that chemical and biological materials used in CAM are neither well-standardized nor made under general manufacturing principle (GMP) conditions; these materials lack purity, stability, bioavailability. or any other preclinical data. Such data are needed since NIH-sponsored trials must be conducted under a Food and Drug Administration (FDA) Investigational New Drug (IND) application. Thus, a challenge to prioritizing and conducting CAM trials is the ability to obtain clinical trial material with the requisite qualities. To some degree, the Botanical Centers Program addresses issues of product quality and standardization. The program attempts to: 1) identify and characterize botanicals; 2) assess bioavilability and activity; 3) explore mechanisms of action; 4) conduct preclinical and clinical evaluations; 5) offer training and career development; and 6) help select the product to be tested in RCTs. The program was developed with the NIH Office of Dietary Supplements (ODS). Dr. Straus then described NCCAM's clinical trials program. There are currently five RCTs being conducted in conjunction with other NIH Institutes: Hypericum for depression (Duke University; cosponsored the National Institute of Mental Health). Depression affects an estimated 19 million people at a cost of $44 billion per year; Ginkgo biloba to prevent dementia (University of Pittsburgh; cosponsored by the National Institute on Aging). Dementia affects an estimated 4 million, with 22,000 deaths, at a cost of $100 billion; Acupuncture for osteoarthritis pain (University of Maryland; cosponsored by the National Institute of Arthritis, Musculoskeletal and Skin Diseases - NIAMS). Pain affections 7.5 million, and costs $100 billion annually; Glucosamine/chondroitin sulfate for osteoarthritis (University of Utah; cosponsored by the NIAMS). Osteoarthritis affects an estimated 21 million people, with associated costs of $65 billion each year; and Shark cartilage for lung cancer (M.D. Anderson Cancer Center; cosponsored by the National Cancer Institute). Besides addressing the efficacy and safety of an intervention, RCTs offer several other opportunities including the ability to: 1) collect data on the natural history of disease presentation and progression; 2) test biomarkers as more rigorous outcome measures than subjective rating scales; 3) define drug pharmacokinetics; 4) determine underlying mechanisms of action; and 5) study the "placebo effect." NCCAM is sponsoring a fall workshop on the placebo effect in conjunction with the National Institute of Diabetes, Digestive Disorders and Kidney Disease and several other NIH Institutes. Next on the agenda was an oveview of the proposed NCCAM intramural research program. The program will consist of the following: 1) clinical research; 2) collaborative preclinical research; 3) clinical epidemiology and biostatistics (NCCAM is seeking a person with appropriate expertise to help with field studies and formalize processes); and 4) research training. A new program, the frontier medicine research program, will incorporate a mechanism to identify and test CAM modalities for which there is little evidence of benefit, but for which there is substantial public interest. This program will support institutions: 1) with records of clinical research excellence; 2) that possess adequate infrastructure, and 3) that can incorporate relevant CAM expertise into the selection, design, and overview of studies. Next, Dr. Straus outlined the various NCCAM outreach activities including: 1) the NCCAM Clearinghouse, Web-site, and fact sheets; 2) CAM component of the Combined Health Information Database; 3) the CAM Citation Index; 4) the NCCAM quarterly newsletter; and 5) town meetings. The NCCAM Web-site gets about 460,000 hits per month. NCCAM intends to improve the clearinghouse, step up the pace in issuing fact sheets, and improve the Web-site to reflect public comments. The database will interpret information for lay persons. The first Town meeting is in conjunction with Harvard University in March. NCCAM partnership activities include: 1) the Trans-Agency (federal) CAM Coordinating Committee, to promote collaborative CAM studies; 2) clinical trials and SBIR/STTR projects conducted with industry; 3) a dialogue on research and training issues with professional associations; and 4) town meetings and representation on oversight committees for patient groups. In facilitating integration, NCCAM will be conducting research that provides compelling evidence of efficacy and safety. The findings will be publishing in widely circulated, peer-reviewed journals. NCCAM also will initiate studies of the factors that promote integration of CAM and conventional medicine, support educational programs for students and practitioners, and inform the public about research findings in a clear and definitive manner. CAM modalities that are now accepted in mainstream medicine include hypnosis, biofeedback, support groups, aerobic exercise, vitamin and mineral supplements, acupuncture for pain, behavioral therapy, spiritual counseling, low-fat and low-cholesterol diets, physical medicine, and allergen desensitization. Dr. Straus stressed that a critical NCCAM responsibility is proper stewardship of federal resources. This stewardship requires that NCCAM align and properly manage human and physical resources in accord with fiscal resources to meet its mission. This includes recruiting, training, and retaining an excellent and diverse workforce, including CAM-experienced personnel. Proper stewardship also requires that NCCAM prepare for rapid growth, as well as strive for, and reward, staff excellence. CAM funding has risen exponentially. Dr. Straus expects the budget for the center program to decrease, proportionally, over the coming years, while that for research project grants (RPGs) is expected to rise; these budgets currently account for 26 and 37 percent of the total, respectively. In closing, Dr. Straus outlined NCCAM's first year accomplishments including: 1)establishing NCCAM's structure and recruiting effective leaders for each of its functional components; 2) beginning development of first five-year strategic plan; 2) expanding the extramural research program; 3) initiating the first large and well-designed phase III clinical trials for a number of CAM therapies; 4) sponsoring national conferences on critical areas of CAM practice and research; 5) increasing the quality of the Specialized Research Centers Program; 6) funding a broad portfolio of high-quality, investigator-initiated research projects; 7) beginning a national CAM research training program; 8) establishing critical advisory bodies, including the Council, the Cancer Advisory Panel, and the trans- agency coordinating committee; and 9) supporting the establishment of the White House Commission on Complementary and Alternative Medicine Policy. Next followed a question and answer period between Dr. Straus and member of Council. Opening the discussion, Dr. Schlitz requested more information about the new frontier medicine program. Dr. Straus replied that the first iteration will not be a center, but he does feel the capacity to derive reasonable initial knowledge has to come from those who know how to do research. He sees clusters of projects within a particular institution; one project can inform another. What he doesn't anticipate is inefficient little grants scattered around country. Dr. Schlitz also asked if everything on his list qualified as CAM modalities and wondered how they were defining CAM. Dr. Straus answered that CAM is in the eye of the beholder. He spends a lot of time trying to define it. Largely, it depends on whether everyone agrees something is CAM or allopathic. For example, every hospital has clergy on staff, but that doesn't rule out a study of spirituality. He would be interested in anyone's discrete definition. Dr. Kail suggested there was confusion between what is accepted and what is integrated. For example, support groups are accepted but not integrated into allopathic medicine. Scientific evidence alone won't integrate a CAM therapy into the mainstream. Dr. Straus agreed. Research can provide a clearer set of answers. Some practitioners will decide which options to pursue based on what works; some will decide on market processes. Dr. Kaptchuk noted that the priorities will change and noted the existence of the original nine OAM-funded centers. Six of these centers were not successful in their competitive renewal. Dr. Kaptchuk suggested that reconfiguring several of these unsuccessful center applications might be prudent, given their history and infrastructure. He also speculated that some compromise would help these centers become eligible for funding while fitting the congressional mandate. Dr. Straus answered that the growth of NCCAM is difficult, with much change. Areas of expertise are very important. While he does not want to discard established domains of expertise, the centers must meet high standards. Therefore, compromising might be counterproductive. There is a need to support research from many different areas. There is always a compromise in the scheme of things, more so for NCCAM than other NIH Institutes because of the evolving expertise and expectations. NCCAM has offered to help several of those centers that did not recompete successfully. There are other mechanisms under which they can apply, and NCCAM will provide transition support. The NIH funding stream is never guaranteed; periodic reviews are part of it and there are no entitlements. The only thing that counts is excellence. If those organizations that have fallen out could present better applications the next time, it would benefit everyone. Ms. Holloran asked about development of CAM from an institutional standpoint. She thought centers were to create a capacity to provide a place for study and was concerned about breaking that up. Straus said they are slowing the rate of growth for centers, which are heavily promoted, and they are trying to build expertise in the centers and elsewhere. NIH has no responsibility for funding development of a discipline. The responsibility is to promote research. The research portfolio emphasizes what can be researched now. However, NCCAM is also interested in studies of more complex modalities. Dr. Nahin added that at the August meeting, staff presented a concept clearance on "Traditional, Indigenous Systems of Medicine" that is specifically designed to address complex systems of medicine. Dr. Kahn brought up the issue of priorities. She fundamentally agreed that the relative emphasis on centers should diminish, but CAM is in a different developmental stage from many other NIH disciplines, so for the next 5 to10 years, they might want to support more centers in order to have a critical mass of expertise. Dr. Straus stated that NCCAM will be adding more centers over time, which is a big investment. His concern was that expectations overpower the capacity for NCCAM to support a broader research agenda. Budgets ebb and flow, and it is important not to get too locked in. Dr. Cantwell asked what percentage of the research portfolio should be carried out by conventional institutions, CAM institutions, and consortia of the two. Dr. Straus noted that they can only fund what comes in and meets their standards for excellence. Conventional institutions have a tradition of this research and are now waking up to these opportunities. They want to know how to get in on CAM research. However, they have disadvantages because they lack expertise in the topics, despite expertise in the process. Nontraditional institutions have the reverse situation. For example, Maharishi University in Iowa is funded because they had a good application containing both rigorous methodology and CAM expertise. Dr. Kaptchuk would like to see placebos on the agenda as a direct focus. Dr. Straus said that NCCAM will lead a workshop on this suggestion with other NIH Institutes. They are just beginning the background work on this and will have experts on various topics. Multiple institutes will then join together to fund the workshop. NCCAM will fund the portion of these studies having to do with CAM. Dr. Schlitz observed that OAM had a previous placebo workshop. Dr. Straus agreed that there have been many such projects. They will focus on what the research agenda could be for this workshop. A report is not adequate; he wants a series of actionable recommendations. Dr. Kahn asked what definition of placebo they would use. Dr. Straus said that the definition is part of what they are researching. Dr. Grimm said that 80% of what is done in regular medicine is not based on "good science," either. He wants NCCAM to think in terms of treatments. Dr. Kail suggested putting together a meeting on the issue of methodology around multivariant protocols. They need to define the best tools and get to the crux of the major difference of protocols vs. single agents. Dr. Straus suggested they ask how to discover if there is a particular individual from the large group under study who truly benefits for a particular treatment. There may be an individual who benefits more than the aggregate, but standard scientific methodology seldom answers this. If they knew this, practitioners and patients could select their own actions. Designing complex modality studies is another story. Some people say it cannot be done. But Dr. Straus believes it is possible to apply rigor, even outside of a double-blind trial. For example, there might be a situation in which a particular way of using Chinese medicine has practitioners prescribing differently. They could have a center with a cadre of experts and let them prescribe as they will, and patients would get either a prescription or a placebo. A large enough patient population would allow them to see if results are generalizable. Dr. Cantwell asked about the vision for the intramural program. Dr. Straus explained that it provides an opportunity to do research in a rich environment in unique way; it allows risk-taking. The biggest difficulty will be in setting priorities. Dr. Schlitz asked about the role of prevention. Dr. Straus noted that the Ginkgo biloba trial is a prevention trial. They will do such studies where possible. Steve Rafferty of ITTRI (NCCAM's information technology contractor) demonstrated the Complementary and Alternative Medicine Citation Index (CCI). CCI began in 1998, with 92,000 records in a flawed data set. ITTRI began anew, with 182,000 in September 1998; monthly updates began a year later. The CCI is moving to a new server. The CCI used a Boolean search engine at first, but that requires knowledge of the appropriate terminology. So ITTRI developed a vector space retrieval mode, which produces good results. It addresses scalability; it is more flexible; and it looks and feels like the familiar Web search engine. The theory is that documents with the same words are on the same topic. Users can enter queries in "natural language," choosing up to three fields in combination, with a date limit option. There is a CAM menu. ITTRI will track peoples' interests and set the menu criteria accordingly. The CCI will be accessed through the NCCAM Web-site once it has been approved; the previous version is up now. VIII. Proposed Program Initiatives
Project Concept Review: Integrated Medicine
So the issue is, what are barriers to CAM use, how can they overcome the barriers, and what is the best way to monitor patterns of use once the barriers are overcome? NCCAM proposes to fund 7 to 10 proposals for up to $500,000 each, some in co-sponsor relationships. These will be 4-year projects that will be evaluated at the end and may be re-funded at that time. It is important to note that this must all occur within the NIH structure. Dr. Meeker noted the emphasis on integrating CAM into conventional medicine rather than the other way around. An initiative like this speaks to social and health policy issues on how health care is delivered. He suggested they look at the larger picture. Dr. Nahin said the applicants will have to incorporate practitioners of alternative medicine because it is unlikely medical physicians will also be acupuncturists, for example. Dr. Kail said that most care is being referred and picked up via insurance rather than being done side-by-side. His experience is that a referral to him results in him reporting back but no follow-through after that by the medical physician. He wondered if insurance companies will want others looking at this proprietary information. Dr. Nahin explained that at an October meeting, insurance professionals were asking questions about what to do with this type of information, how to use it, etc. Dr. Grimm advised thinking about outcomes. Some CAM practitioners will see certain patients that are hard to treat because they are worse off in the first place. There are many ways of confounding and confusing information coming out of such studies. Dr. Kahn agreed, wanting to see more emphasis on integration process than on outcomes. Dr. Kaptchuk suggested that NCCAM not prejudge the best way to integrate CAM and traditional therapies. It may be that CAM has a heightened placebo effect, so is there benefit in the patient going outside conventional medicine to find it? Dr. Standish brought up the insurance issue. Although Washington State in 1995 mandated coverage of CAM, which lends itself to this concept as a venue, it was not obvious when she read the proposal; she would like it rewritten to make that part of it more obvious. She also requested, and Dr. Nahin agreed, to have a definition of "efficacious" in the proposal. In addition, she was concerned about mainstreaming CAM practices; she suggested they be careful about the proposal language being one-sided. Dr. Nahin explained that the proposal did not preclude something like chiropractors using acupuncture. Dr. Meeker suggested replacing "standard" with the word "interdisciplinary." Dr. Nahin reminded them that they could not see the draft of the RFA because it would create a conflict. The source of the conflict is that some panelists might want to apply for these grants, and if they saw the draft RFA, they would be precluded from participating. Panel members could, however, receive copies of RFAs when they come out. Dr. Cantwell suggested the document focus carefully on barriers to integration and utilization of CAM rather than outcomes. Dr. Nahin added that they will be looking at behavioral changes, so likely applicants will be health services researchers. Dr. Cantwell said they should include finding out why the referral occurs. Dr. Kaptchuk added that there could be adverse effects that might not be reported. Dr. Kahn suggested the language focus on the institutional level, and Dr. Grimm advised that the outcomes be phrased as "cost description" as opposed to "cost effectiveness." Others mentioned patient demand, which Dr. Nahin agreed to describe more fully in the final RFA. Ms. Holloran asked Dr. Nahin to review what it is that they will know after this initiative is completed. He replied that they want to know if there are barriers or incentives that are unique or identical to conventional medicine. They want to identify issues unique to CAM and develop solutions as a second step. Once they know what the barriers are, they can set up systems to overcome them. Finally, they want to know if, incorporating CAM into standard care changes patient outcomes. The vote to approve was unanimous. At that point, the public portion of the meeting ended for the day, and the session adjourned at 12:45 p.m. IX. Review of ApplicationsThe afternoon closed session reopened at 1:45 p.m. A total of 115 applications were assigned to NCCAM. Of these, 44 were reviewed by NCCAM with the rest reviewed by the Center for Scientific Review. Applications that were noncompetitive, unscored, or were not recommended for further consideration by the initial review groups were not considered by Council. Council reviewed 39 applications requesting $ 65,069,771 in total costs. Council concurred with 37 new research grant applications for a total cost of $ 61,847,192. The closed afternoon session was adjourned at 6:00 p.m. DAY TWO - JANUARY 25, 2000X. Call to OrderNACCAM reconvened with an open session at 8:30 a.m. on January 25, 2000. Dr. Richard Nahin, Executive Secretary, called the meeting to order. Discussion resumed with presentation of proposed initiatives. XI. Proposed Program Initiatives, ContinuedProject Concept Review: Frontier Medicine Neal West, Ph.D., presented the "Frontier Medicine" concept clearance proposal. He defined frontier medicine as those CAM practices for which there is no plausible biomedical explanation. Examples include bioelectromagnetic therapy, energy healing, homeopathy, and therapeutic prayer. Despite the fact that the U.S. public uses these therapies extensively, there is very little high quality data available to elucidate or demonstrate safety, efficacy, effectiveness, and the mechanism underlying these approaches. Frontier medicine practitioners are generally isolated from the kind of infrastructure that conventional medicine and academic institutions provide. This proposed initiative would establish a program that would include a stable infrastructure to provide institutional support and resources to carry out the kind of rigorous scientific investigation that is the NIH standard. The program will have several focal points. One is to have a synergistic collaboration among smaller, exploratory, developmental research projects. NCCAM wants to provide enriched training and a career development environment. NCCAM also wants to include the possibility of small pilot research projects. They also hope to increase the probability that some of these new approaches will contribute to standard medical practice. Eventually, NCCAM expects the resulting data will serve as the basis for more ambitious research studies. The proposed funding mechanism is the P20, the Exploratory Grants Program. The idea is to have about three P20 projects that are funded at about $600,000 each, per year. Exploratory grants exist to support planning new programs; expansion or modification of existing resources; and feasibility studies that examine approaches to development of interdisciplinary programs. The requirement for background data would not be as rigorous as for some other projects. The idea is that the programs will last for three years; after that, they are unsure of the direction of the program. This is an intermediate step to build infrastructure and bring people together. The expectation is that at some point, the successful P20 applicant will be ready to compete in a larger environment. There was some discussion of whether the P20 program would address a disease or condition across disciplines, or whether there would be a homeopathy project, for example. NCCAM has not yet ruled out various permutations. Dr. Nahin added that they did not intend to narrow topic areas as with the other initiatives. For any multiproject grant, even a P20, there must be something that unites the projects together, however. Dr. Standish wondered if any one city in the United States would have the critical mass of scientists to create a center. She assumed that the best projects would be consortia efforts. Dr. West discussed the pros and cons of distance collaborations. The important thing is to have individuals who are accustomed to working together. Dr. Nahin reiterated that these projects would not be renewable like P50s. The hope is that the data would be the foundation for some other mechanism. In terms of the peer review process, Dr. West assured the council that the review team would work from the RFA, which would define the program. Ms. Holloran expressed concern that investigators not use methodologies that will end up going nowhere. Some attention must be paid to methodological issues. Dr. West agreed, suggesting that a focused research team working together will generate a theoretical foundation, along with the practical aspects of conducting disciplined research. In terms of reaching the practitioners, many of whom are scattered geographically, Dr. West noted that all announcements appear on the Web-site the day they are issued; the staff is open to other ways of spreading the word. The fact that the practitioners may be isolated is something they have considered. The P20 projects would address that by forming collaborations among practitioners and established researchers, although it obviously won't work with everyone. Dr. Olness suggested they include diagnostic strategies as well as treatment strategies, which Dr. West said they had not ruled out. Discussion turned to the pros and cons of bringing personnel from the various P20s together for an annual meeting. Dr. Nahin suggested a workshop as a possibility the staff could investigate. Dr. West also proposed a potential applicant information meeting that would facilitate networking among those who had not yet formed groups. It was also pointed out that these are not resource grants, they are research grants, and the NCCAM staff did not expect them to fund much equipment, if any. In addition, individual institutions could send in multiple applications. A vote was taken; support for clearance was unanimous.
Project Concept Review: Natural Products Development
To highlight some of the issues, Ms. Evans noted that feverfew has been demonstrated to be effective in reducing migraines. But the results conflict, possibly because of a critical variation in the formulation of the extracts. By contrast, valerian root, used for insomnia, might produce an effect based on several types of constituents. Echinacea epitomizes the problem — there are nine species of the plant; the extracts cannot be clearly distinguished from one another and have unequal distribution in the various parts of the plant; there are variations by season, soil type, and climate. Milk thistle is much closer to being standardized. The initiative, therefore, would support projects that could lead to the development of appropriate standardized products and provide reliable and constant supplies of the source material that will assure the quality of study outcomes. Each grantee will be asked to review the literature to determine the appropriate product for each of these four herbs. The purpose is to: 1) identify the species of plant and describe its physical characteristics; 2) describe and provide high quality source material; 3) identify the constituent profile; 4) assess bioavailability and pharmacokinetics; 5) conduct stability testing; 6) develop procedures for assuring the standardization of the product; 7) develop the capability to provide the standardized herbal product in sufficient amounts for trials; 8) develop a drug master file at the FDA. NCCAM expects to spend $2 million in the first year, with project periods up to three years. Similar RFAs may be released in the future as other herbs appear ready for trial testing. This grant would cover the four herbs listed, though they are open to suggestions for others. Garlic was suggested, but a systematic review on garlic is already underway at the University of Texas. They will then know whether or not to pursue garlic further. Dr. Grimm wondered if it might be a good idea to identify the major sellers already in the community, and check what people are actually taking. Dr. Kail said that whole plant substances are synergistic, with multiple variables interacting together. An attempt to isolate an active substance might be a disservice to the plant. It might be better to look at whole plant substances. Ms. Evans agreed, as did Dr. Standish. Dr. Nahin reminded them that the purpose is not to judge single isolates, but rather to find botanical products that can be standardized and made available to researchers throughout the country. These would be national resources for the particular products; the standardized products would allow for comparisons across studies. Dr. Kail suggested that manufacturers would compare their products to the "fingerprint" and possibly promote their own products as superior to the fingerprint. Dr. Straus said that the marketplace will cause industry to compare their products and say that it meets the national reference standard, then advertise it as such, thus moving them all toward the standard. Ms. Holloran asked about the role of the FDA. Dr. Kail said that this would be a very elegant way of solving the problem of the industry fighting standardization as being restrictive and reducing access. Dr. Nahin reminded them that the FDA does not normally regulate these products, and would allow investigations to occur with federal money. Dr. Straus added that the FDA's only responsibility would be to remove a product if there is evidence that it is unsafe. The vote for concurrence was unanimous.
Project Concept Review: Traditional Medicine in Developing Countries
Although there have been successes during the past 30 years in improving the health of women and children worldwide, there remains an unfinished agenda of unnecessary, preventable deaths, illness, and disability that disproportionately affects poor women and children, especially in the developing regions of the world. Research is urgently needed to help improve the health of women and children in these developing countries, making the current initiative important and timely. It is suggested that this initiative support independent research projects using the cooperative agreement mechanism, the U01. The various projects would be joined through a coordinating center to form a loose network of research sites around the world. Sites could be in Africa, Asia, India, or in any developing country. The coordinating center would be established by NICHD. All the various sites would use this data coordination site to manage their trials, analyze trial data, and allow cooperation and collaboration among investigators. The data collection site would facilitate comparisons across trials by using common outcome measures. There are two overall objectives. The first is to establish a research base for studying traditional medicine in the countries of their origin. NCCAM would look at systems of medicine practiced within the cultural context of their country of origin. This might eventually allow comparisons about efficacy of the medicine as practiced in the United States versus the country of origin. The other goal is to develop low-cost, effective, accessible intervention or prevention methods for women and children in these developing countries where conventional medicine is not available or understood. Initiatives with other NIH Institutes are planned for the future. Ms. Holloran noted that the Agency for International Development (AID) has been funding this kind of project heavily for years, and they have rich literature on the topic. Dr. Nahin observed that NICHD has ongoing communications with researchers and investigators, and they have been picking up ideas already. Dr. Olness suggested that in reality, in many of these situations, there is a mixing of medications and herbs, so that patients are not using just one method or the other. Dr. Nahin explained that in partnering with NICHD, the RFA would likely state specific disease areas. NCCAM will only fund CAM projects. There would be a special emphasis panel to review applications submitted under this RFA, and NCCAM would have input into adding traditional medicine experts. Proposed funding is $500,000 per year for up to five years, for each of two to four projects; NICHD would fund two or three times that amount. In answer to a question by Dr. Kahn, Dr. Nahin explained that U.S. and Canadian tribal groups would not be considered as eligible for this initiative. Studies on these populations would be done in collaboration with the Indian Health Service; other current NCCAM initiatives specifically include Native American medicine. The concept was approved unanimously. XII. Public CommentThere was no public comment. XIII. General DiscussionThe Council discussed some business matters before adjourning. It is likely that some of the concepts will be out by spring, and some by the end of summer. The goal is to get them going out at a regular rate, which has not been possible while NCCAM has been staffing up. Regarding the Statement of Understanding, Dr. Nahin asked to confirm that the Council wanted him to put "regarding peer review" in the title, so that it is clear what the statement is about. He also understood the panel to want him to include the 1999 appropriations language, as well as language from the charter. Dr. Straus noted that there was discussion on the program significance of many of the ratings given to certain research projects. He would be in favor of striking the expedited clause for the time being. He also got the sense that the Council members feel they should look at projects in Council because some of those projects with high ratings did not have much program relevance. Dr. Meeker suggested that at one of the meetings they discuss program relevance. He would like NCCAM staff to indicate where they think proposals fit into the overall scheme of things. He also did not feel they had yet come together in terms of agreeing what should be high or low priority, causing more discussion of proposals than is actually necessary. Dr. Straus explained that at other NIH Institutes and C enter council meetings, there are presentations of different parts of the program, something that might be two years down the line for NCCAM. He also suggested that they could pull together an overarching discussion of what is in their portfolio. Dr. Meeker said he did not have a good sense of what projects are in the portfolio, although it's probably available on the Web site. Dr. Straus replied that NCCAM's first year was responsive and reactive rather than proactive, which they are trying to change. So far, they have been funding the best of the applications that have come in, without trying to direct the application stream. The initiatives discussed at this meeting will help them move in that direction. Ms. Holloran noted that the Expedited Award of Meritorious Applications section of the statement changed. Dr. Nahin replied that under NIH policy, it must be a single reviewer who speaks for the entire council. Ms. Holloran suggested that they are not ready to expedite, and Dr. Nahin agreed, hoping that they could begin this process in October. There may need to be a meeting in October or November, since the August meeting will have too much work associated with it as the NCCAM portfolio increases. Under the single reviewer policy established by NIH, all grants go to all council members, who then convey their concerns to the official reviewer. He, in turn, will convey the overall council recommendation to NIH staff. There was some discussion of taking this process to e-mail via a list server. Dr. Nahin explained that there is something called Electronic Council Books, in which everything is sent to council members electronically. Council has its own chat room associated with the Electronic Council Books. This will probably not happen before October, if then. The chat room will allow Council members to discuss their concerns about applications with each other, and NCCAM staff will be able to view those comments as well. The Council members present voted on adopting the Statement of Understanding with the amendments. The vote was unanimous in favor of the Statement. Dr. Kahn raised the issue of initiatives or concepts emerging from the Council itself. The subcommittees would see to that once they become functional. They need chairs, however. The Information Dissemination subcommittee has been meeting informally by e-mail, and the CAPCAM subcommittee had a meeting. Dr. Nahin noted that at other institutes, subcommittees divide up the applications according to the research program to avoid having all Council members deal with an enormous number of applications. The subcommittee members conduct a preliminary review, then make recommendations back to the full Council. XIV. AdjournmentThere being no further business, the meeting was adjourned at noon on Tuesday, January 25, 2000. The next meeting is scheduled for May 8-9, 2000. We hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.
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. 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. |
