Date: May 22, 2006
Place: Building 31, Conference Room 10
National Institutes of Health
Bethesda, Maryland
U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
The 182nd meeting of the National Advisory Dental and Craniofacial Research Council (NADCRC) was convened on May 22, 2006, at 8:40 a.m., in Building 31, Conference Room 10, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:40 a.m. to 11:40 a.m., followed by the closed session for Council business and consideration of grant applications from 1:00 p.m. until adjournment at 3:30 p.m. Dr. Lawrence A. Tabak presided as Chair.
Members Present:
Dr. Matthew J. Doyle
Dr. Marianne Bronner-Fraser
Dr. Augusto R. Elias-Boneta
Dr. Linda G. Griffith
Dr. Mark C. Herzberg
Dr. Josephine Lai
Dr. Jon D. Levine
Dr. Anne S. Lindblad
Dr. Michael Reed
Dr. Philip Stashenko
Dr. George Taylor
Members of the Public Present:
Mr. Jack Bresch, Associate Executive Director, American Dental Education Association (ADEA), Washington, DC
Dr. Aida A. Chohayeb, Women Network Collective Research, Washington, DC
Dr. Christopher Fox, Executive Director, International Association for Dental Research (IADR) & American Association for Dental Research (AADR), Alexandria, VA
Dr. Frank A. Kyle, Jr., Manager, Legislative and Regulatory Policy, American Dental Association (ADA), Washington, DC
Ms. Gina Luke, Director, State Government Relations and Advocacy Outreach, ADEA, Washington, DC
Ms. Monette McKinnon, Director, Grassroots Advocacy and State Issues, ADEA, Washington, DC
Dr. Steven Q. Morefield, Scientific and Medical Strategic Initiatives, CONSTELLA Group, Rockville, MD
Ms. Myla Moss, Director, Congressional Relations, ADEA, Washington, DC
Dr. Daryl Pritchard, Director of Legislative Affairs, IADR & AADR, Alexandria, VA
Dr. Richard Valachovic, Executive Director, ADEA, Washington, DC
Federal Employees Present:
National Institute of Dental and Craniofacial Research:
Dr. Lawrence A. Tabak, Director, NIDCR
Dr. Albert Avila, Extramural Training Officer, Office of the Director (OD)
Dr. Robert C. Angerer, Scientific Director, Division of Intramural Research (DIR)
Dr. Sangeeta Bhargava, Program Director, Immunology and Immunotherapy Program, Center for Integrative Biology and Infectious Diseases (CIBID)
Dr. Henning Birkedal-Hansen, Associate Director for Program Development, NIDCR
Ms. Karina Boehm, Chief, Health Education Branch, Office of Communications and Health Education (OCHE), OD
Dr. Norman S. Braveman, Executive Secretary, NADCRC, and NIDCR Board of Scientific Counselors, and Assistant to the Director, OD
Dr. Patricia A. Bryant, Program Director, Basic and Applied Behavioral/Social Science Research Program, Center for Health Promotion and Behavioral Research (CHPBR)
Dr. María Teresa Canto, Program Director, Health Promotion and Community-Based Research Program, CHPBR
Mr. Hong T. Cao, Grants Management Specialist, Grants Management Branch (GMB), Division of Extramural Activities (DEA)
Dr. Lois K. Cohen, Associate Director for International Health, NIDCR, and Director, Office of International Health (OIH)
Mr. George J. Coy, Chief, Financial Management Branch (FMB), Office of Administrative Management (OAM)
Ms. Mary Daley, Chief Grants Management Officer, GMB, DEA
Ms. Yvonne H. du Buy, Associate Director for Management, and Director, OAM
Dr. Isabel Garcia, Acting Director, Office of Science Policy and Analysis (OSPA), and Co-Director, Residency Program in Dental Public Health at NIDCR
Dr. Kevin Hardwick, Extramural Training Officer, NIDCR
Dr. Rosemarie Hunziker, Program Director, Technology Development and Industrial Relations Program, Center for Biotechnology and Innovation (CBI)
Dr. Timothy Iafolla, Research Consultant, OSPA
Dr. Lynn M. King, Scientific Review Administrator, Scientific Review Branch (SRB), DEA
Dr. Dushanka V. Kleinman, Deputy Director, NIDCR, and Acting Director, CHPBR
Dr. Eleni Kousvelari, Acting Director, CBI
Dr. John W. Kusiak, Director, Molecular and Cellular Neuroscience Program, CIBID
Ms. Carol Loose, Budget Analyst, FMB, OAM
Dr. Nadya Lumelsky, Program Director, Tissue Engineering and Regenerative Dental Medicine Program, CBI
Mrs. Jayne Lura-Brown, Program Analyst, CHPBR
Dr. Dennis F. Mangan, Program Director, Microbiology Program, CIBID
Ms. Amy McGuire, Grants Management Specialist, GMB, DEA
Dr. Pamela McInnes, Director, CIBID
Dr. Richard L. Mowery, Program Director, Epidemiology Program, Center for Clinical Research (CCR)
Dr. Mostafa Nokta, Program Director, AIDS and Immunosuppression Program, CIBID
Dr. Ruth Nowjack-Raymer, Program Director, Health Disparities Research Program, CCR
Ms. Helen Pham, Grants Management Specialist, GMB, DEA
Dr. Bruce Pihlstrom, Acting Director, CCR, and Program Director, Clinical Trials Program, CCR
Dr. Yasaman Shirazi, Program Director, Epithelial Cell Regulation and Transformation Program, CIBID
Dr. Lillian Shum, Program Director, Mineralized Tissue and Salivary Gland Physiology Program, CIBID
Dr. Rochelle Small, Program Director, Developmental Biology and Genetics Program, CIBID
Ms. Ruth Dianne Thorpe, Administrative Officer, OAM
Ms. Traci Walker, Committee Management Assistant, OD
Other Federal Employees:
Dr. Clifton M. Carey, Director of Administration, ADA Foundation’s Paffenbarger Research Center, National Institute of Standards and Technology, Department of Commerce, Gaithersburg, MD
Mr. William Foley, Extramural Support Assistant, Division of Extramural Activities Support (DEAS), Office of the Director (OD), NIH
Dr. John P. Kim, Office of Policy for Extramural Research Administration, Office of Extramural Research, OD, NIH
Dr. William Maas, Director, Division of Oral Health, Centers for Disease Prevention and Control, Chamblee, GA
Mr. Jeffrey M. Ortiz, Extramural Support Assistant, DEAS, OD
Dr. Ravi K. Sawhney, Office of Science Policy and Planning, Office of Science Planning, OD, NIH
OPEN PORTION OF THE MEETING
I. WELCOME AND INTRODUCTIONS
Dr. Lawrence A. Tabak, Director, NIDCR, called the meeting to order and welcomed everyone. He extended a special welcome to Dr. Marianne Bronner-Fraser, a new Council member, and invited all guests to introduce themselves.
Dr. Tabak announced the departure of three staff members from the NIDCR. Dr. Richard L. Mowery, Program Director, Epidemiology Program, Center for Clinical Research, is retiring from government service on July 31. Dr. Dennis F. Mangan, Program Director, Microbiology Program, Center for Integrative Biology and Infectious Diseases, is leaving the government on June 24 to become Associate Dean for Research, University of Southern California School of Dentistry. Dr. Lois K. Cohen, Associate Director for International Health, and Director, Office of International Health, is retiring from government service on June 2 and will continue at NIDCR as a consultant and advisor.
II. APPROVAL OF MINUTES
The minutes of the Council’s meeting on January 23, 2006, were considered and unanimously approved.
III. FUTURE COUNCIL MEETING DATES
The following dates for future Council meetings were confirmed:
September 18, 2006
January 22, 2007
May 18, 2007
September 24, 2007
January 25, 2008
June 6, 2008
September 26, 2008
IV. CONCEPT CLEARANCES
Dr. Norman S. Braveman, Executive Secretary, NADCRC, introduced the presentation of five concepts for Council’s approval. For each concept, two Council members served as leads for the discussion and presented in-depth reviews of the concept. Detailed, written concepts were provided to the Council.
During the discussion periods, the Council suggested that, for each concept, the NIDCR convey deliberately and directly its interests in supporting the proposed research. Members suggested that all written concepts include (i) a bulleted list of specific objectives, (ii) an annotated list of examples of proposed research activities, and (iii) a statement of outcomes expected by the NIDCR.
Health Promotion Research: Oral Health Promotion across the Life Span
Dr. María Teresa Canto, Program Director, Health Promotion and Community-Based Research Program, Center for Health Promotion and Behavioral Research (CHPBR), presented a proposed initiative to stimulate and support meritorious population research to improve health and prevent diseases and/or their sequelae through three life stages: maternal and child health, adolescents and young adults, and adults with complex chronic diseases. The research objectives are to (a) develop and test oral health promotion strategies that apply or adapt existing, or develop new, behavioral theories and planning research models for known risk factors and lifestyle aspects of oral diseases and conditions; (b) promote optimal oral health of individuals, families, and communities; and (c) integrate oral health promotion into general health promotion programs.
The proposed initiative would be announced in three Funding Opportunity Announcements (FOAs), to invite applications at different stages of research development. Research applications would be sought for (i) pilot data grants for health promotion research, for 2 years, to conduct epidemiological, social, and environmental needs assessments; (ii) planning data grants for health promotion research, for 1 year, to build partnerships and coalitions among stakeholders and to develop a plan for research based on the data collected; and (iii) research grants for health promotion research, for up to 5 years, to conduct and test research interventions. The proposed approach is consistent with the model used for the NIDCR clinical trials program.
The Council leads agreed that the proposed initiative would fill a research need, have a potential impact on health outcomes, and engage the research community in translating basic knowledge to preventive interventions. The leads suggested that the NIDCR convene workshops and symposia to address the existing research portfolio, identify research areas of potential high impact, and engage dental and behavioral scientists to partner in this research. The leads encouraged the NIDCR to explore cofunding relationships with other institutes and centers (ICs) that have a strong interest in behavioral and health promotion research and to peruse the findings of other ICs’ workshops addressing similar research. Dr. Canto noted that the NIDCR is planning to convene a technical assistance workshop on the NIDCR health promotion program, in the fall of 2006, as well as a symposium for the annual meetings of the International Association for Dental Research, American Association of Public Health Dentistry, and the National Oral Health Conference.
The Council unanimously approved the concept.
Health Promotion Research: Health Promotion Research Directed to Improving
the Oral Health of Women and Their Infants
Dr. Canto presented a proposed initiative to support health promotion research directed at women before, during, and after pregnancy to improve the well-being of themselves and of their infants. The research could encompass (i) testing of behavioral theories and/or health promotion models to encourage preventive activities of oral health; (ii) development, implementation, and evaluation of oral health promotion research specific to the targeted population; and (iii) research on how to integrate oral health into existing health promotion programs for women before, during, and after pregnancy.
Dr. Canto noted that most of the research related to maternal and child oral health in the NIDCR portfolio focuses on two major areas: the relationship between periodontal disease during pregnancy and infants’ low birthweight, and the prevention of early childhood caries. Most NIDCR projects are directed toward the child and, yet, to prevent early childhood caries, health promotion interventions are needed before a child is born. Maternal and infant oral health problems may be preventable by changing a mother’s lifestyles and behaviors while she is pregnant. An area little explored is the relationship between an infant’s oral health and a mother’s oral health status, needs, and behaviors before and during pregnancy. Enhancing women’s knowledge of nutrition and ways to prevent dental caries, periodontal diseases, and craniofacial anomalies is essential.
The Council leads noted the importance of this research initiative to improve the oral health of women and their infants. They encouraged the NIDCR to convene a symposium of clinical researchers and behavioral scientists to address the status and future directions of this research and to foster collaborative interdisciplinary research. The leads noted the need to design a strategy to link and “market” the two oral health promotion research initiatives which Dr. Canto presented and to encourage other ICs to participate in funding this research. The Council suggested that the NIDCR modify the wording of the concept to link the proposed research to emerging evidence on the transmissibility of cariogenic pathogens from mother to child and to ongoing trials of the relationship between mothers’ periodontal health and infants’ low birthweight.
The Council unanimously approved the concept.
Bisphophonates-associated Osteoneocrosis of the Jaw: Pathophysiology and Epidemiology
Dr. Lillian Shum, Program Director, Mineralized Tissue and Salivary Gland Physiology Program, Center for Integrative Biology and Infectious Diseases (CIBID), presented a proposed initiative to stimulate research to determine the pathophysiology and epidemiology of osteonecrosis of the jaw (ONJ), a morbid condition associated with bisphosphonate use. The initiative was jointly prepared by CIBID and the Center for Clinical Research (CCR). Dr. Shum noted that bisphosphonates are prescribed for two major indications: to alleviate bone pain in cancer patients with bone metastases and to reduce bone loss in individuals with osteoporosis. In the United States, approximately 1.8 million cancer patients are being treated with bisphosphonates and, in 2005, physicians wrote 36 million prescriptions for bisphosphonates to treat osteoporosis, mostly in women. The purpose of the initiative is to understand the development of ONJ, which occurs in a subset of these patients and which presents as non-healing or slow-to-heal bony lesions which are often complicated by oral infections.
Dr. Shum noted the strong evidence supporting the effectiveness of bisphosphonates for their intended use and also the significant gap in understanding whether bisphosphonates interfere with bone healing at the genetic, molecular, cellular, and tissue level. The goal of the initiative is to understand the prevalence, incidence, and risk factors of individuals’ susceptibility to ONJ and to characterize the pathophysiological mechanisms underlying the development of ONJ. By accelerating research discovery, it may be possible to better predict which individuals may benefit from bisphosphonate treatment with and without risk of ONJ and how to overcome ONJ. The overall aim is to foster personalized recommendations for bisphosphonate therapies and new strategies for preventing and treating ONJ while also managing bone cancer pain and osteoporotic bone loss.
The Council leads stated that the proposed concept is timely and well-prepared. They commented on reports in the dental literature and public media concerning biphosphonate-associated ONJ and noted that the American Academy of Oral Medicine published guidelines for managing ONJ in December 2005. The leads commented that the target osteoporotic population is large although the incidence of ONJ in this population appears low and that the proposed combination of basic and epidemiological research is appropriate. They suggested a change in the wording of the concept to separate animal studies from NIDCR’s emphasis on human studies. The leads cautioned that researchers need to distinguish between clinically meaningful lesions and subclinical conditions.
The Council suggested that the NIDCR could broaden the initiative to consider the possible different effects of biphosphonates on jaw and skeletal bone. The members encouraged NIDCR to engage other ICs (especially the National Institute for Arthritis and Musculoskeletal and Skin Diseases) in this effort. Noting the low incidence and many variables pertaining to ONJ, the Council encouraged the NIDCR to work closely with epidemiologists to construct a valid design for the concept.
The Council unanimously approved the concept.
Immunology of Biofilms
Dr. Sangeeta Bhargava, Program Director, Immunology and Immunotherapy Program, CIBID, presented a proposed initiative to stimulate research on the host response to microbial biofilms leading to improved strategies to diagnose, prevent, and treat biofilm-associated infectious diseases. She noted that biofilms, accumulations of microorganisms embedded in a polysaccharide matrix and adherent to a solid biological or nonbiological surface, are clinically important and account for more than 80 percent of microbial infections in the body. Yet, despite continual exposure to commensal and pathogenic bacteria, normal mucosal surfaces resist biofilm infections. The rapid killing of organisms likely accounts for some of this resistance and suggests that mucosal surfaces may possess an anti-biofilm defense.
Dr. Bhargava noted that the NIDCR has invested significantly in research on biofilms, but does not currently support any studies on the host response to biofilms in animals or humans. Few studies have addressed the host response to polymicrobial biofilms, such as in periodontal diseases, or the specific role of biofilm resistance in the human immune system. Understanding the host response to bacterial biofilms was identified by participants at several symposia and workshops recently sponsored by the American Society for Microbiology and the NIH as a major gap in preventing biofilm formation. Accordingly, the goal of the proposed initiative is to better understand the host response to biofilms, the role of saliva and the innate immune system in oral biofilms, and the polymicrobial induction of cytokines and chemokines in the oral cavity of healthy persons and individuals with periodontal disease.
The Council leads noted that the proposed concept is important, timely, well-developed, and consistent with the NIDCR Strategic Plan. They suggested some changes in wording to clarify or modify points. The leads encouraged NIDCR to state clearly that the initiative is specifically focused on biofilms in the oral cavity, while research on other biofilms may be relevant for purposes of comparison. To encourage integration with other research on biofilms supported by the NIDCR, the leads suggested adding the following sentence: “Applicants are encouraged to partner with centers conducting research in these areas.” The Council encouraged NIDCR to link research on oral biofilms more broadly with other elements of the NIDCR research portfolio.
The Council unanimously approved the concept.
Oral Health Disparities Centers
Dr. Ruth Nowjack-Raymer, Program Director, Health Disparities Research Program, Center for Clinical Research, presented a proposed initiative to continue to stimulate research that will accelerate efforts to alleviate oral health disparities in disadvantaged and vulnerable populations (e.g., racial and ethnic minorities, low-income rural and urban communities/residents, and populations with special needs) through the NIDCR-supported Centers for Research to Reduce Oral Health Disparities (CRROHDs). She noted that elimination of health disparities continues to be a priority for the NIH and the NIDCR. The Institute of Medicine, U.S. Surgeon General, and other organizations also have highlighted the national significance of health disparities and the need for additional research. Several recent reports, emanating from the National Health and Nutrition Examination Survey, Indian Health Service, and the Surveillance, Epidemiology, and End Results Registry, have documented significant disparities in oral health, particularly dental caries, periodontal diseases, and oral and pharyngeal cancers.
The proposed initiative represents a competitive renewal of the FOA for CCROHDs. Applicants may include the five current CCROHDs as well as other proposed centers. Four of the current CCROHDs focus on early childhood caries, and one focuses on oral and pharyngeal cancers. Dr. Nowjack-Raymer noted that the CCROHD program has been very productive for the NIDCR. The five centers have undertaken more than 30 studies which include 9 interventions, 7 of which were randomized clinical trials. The research findings are receiving broad media attention. In January 2006, the Journal of Dental Research published the results of two studies, on xylitol and the efficacy of fluoride varnish, and the findings were reported subsequently in the public media. The CCROHDs are having an impact on clinical practice, public health policy, and the entire research enterprise, and they are increasing the cadre of diverse researchers in oral health.
The proposed initiative focuses on dental caries, periodontal diseases, and oral and pharyngeal cancers. It would support research to understand and intervene promptly in complex biological, behavioral, social, and environmental factors and to utilize an array of research approaches, with emphasis on community-based, tailored interventions and initiatives that move research findings into community action, clinical practice, personal skills development, environmental action, and public health policy. The centers would be expected to foster the organization of dedicated, multidisciplinary teams and the development and maintenance of community partnerships.
The Council leads supported the initiative and noted that the objectives are presented clearly. The Council suggested that the initiative be revised to (i) more clearly communicate the focus on the three oral disease areas; (ii) encourage communities and other ICs to participate in the research; (iii) add examples of specific research initiatives for the next 5 years (replacing the section on “Recommendations from Workshops”); and (iv) specify the positive outcomes expected by the NIDCR. The initiative also could include (v) comment and references on the impact of racism and discrimination on health disparities, and (vi) text on the broad, additional benefits of CCROHDs—for example, in stimulating community interactions, government policy, increased awareness of health disparities by dental practitioners, training of young investigators, and communication with other research centers.
The Council unanimously approved the concept.
V. NIH AT THE CROSSROADS: MYTHS, REALITIES, AND
STRATEGIES FOR THE FUTURE
Dr. Elias Zerhouni, Director, NIH, discussed several myths and realities about the NIH budget, the current “drivers” affecting the NIH, and strategies for the near future. He noted that the NIH is unique among Federal agencies for its reliance on more than 31,000 extramural advisors, councilors, and scientific reviewers. He thanked the NADCRC for its leadership and contribution to the NIDCR.
Dr. Zerhouni noted that a “perfect storm” of multiple factors is affecting the NIH budget. These factors include the Federal deficit, defense and homeland security priorities, the costs of Katrina and the potential flu pandemic, and domestic budget cuts. In addition, the NIH faces “post-doubling” effects (e.g., rising congressional expectations after the doubling of the budget), renewed congressional support for the physical sciences, and a biomedical research inflation factor higher than the general inflation.
In the midst of this perfect storm, NIH is confronting a number of myths about the NIH budget. Dr. Zerhouni documented the reality that belies three myths in particular— that NIH is placing more emphasis on applied research than on basic science; shifting support more toward solicited research at the expense of investigator-initiated research; and favoring NIH Roadmap activities. The NIH data which counter these myths clearly show that (i) the NIH is maintaining its historical balance of support for basic and applied research (58.9 percent and 40.5 percent, respectively, in FY 2007) ; (ii) unsolicited research grant awards continue to far outnumber solicited research grant awards (93 percent vs. 4 percent in FY 2005); and (iii) NIH Roadmap activities are, and will continue to be, a very small proportion of the overall NIH effort.
Dr. Zerhouni elaborated on the funding for the NIH Roadmap. He noted that, in FY 2005, Roadmap activities consumed approximately 0.8 percent of the NIH budget. This proportion increases in FY 2006 (to 1.2 percent) and FY 2007 and then levels off in FY 2008–09. Roadmap funding in FY 2005 supported more than 345 awards; of these, 40 percent were for basic research, 40 percent for translational research, and 20 percent for “high-risk” research. Dr. Zerhouni emphasized that the NIH Roadmap creates “incubator space” to accelerate critical interdisciplinary research that addresses major cross-cutting NIH priorities. This “incubator space” is now housed in the Office of Portfolio Analysis and Strategic Initiatives, within the Office of the Director.
Dr. Zerhouni noted that, as the NIH moves forward, three main “drivers” are affecting the biomedical research enterprise. These are (a) the large capacity building and dramatic increase in number of tenure-track faculty at U.S. universities and research institutions over the past 5 years, (b) the large increase in NIH applicants and applications occurring after FY 2003, and (c) budget cycling phenomenon. Dr. Zerhouni elaborated on the temporal shift in the supply of, and subsequent demand for, research dollars as a result of the 5-year doubling of the NIH budget. He noted that, by FY 2003, the NIH began to experience large increases in the number of research grant applicants and applications, and these increases were associated with a decline in the overall success rate of applications. In FY 1998, for example, the NIH received approximately 24,000 new grant applications, and the success rate was 31 percent; in FY 2007, the NIH expects to receive more than 49,600 new applications, and the success rate is projected at 19 percent. Dr. Zerhouni pointed out that, in FY 2003–04 (a 2-year period), the NIH had the same number of research grant applicants as it did in the full 5 years of the doubling phase (FY 1999–03) (8,359 and 8,303, respectively) and had approximately 10,000 new applicants.
The budget cycling phenomenon adds to these effects. Dr. Zerhouni noted that, in any given year, most NIH funds are committed funds from previous years and support continuing grants, while a relatively small proportion of funds from grants which are ending is available as uncommitted funds to support new awards. For example, in FY 2006, the source of much of the funding for continuing grants is the FY 2002 budget, and even though the budget is likely to be stable in FY 2007, the NIH will have uncommitted funds freed up from grants which were funded in previous years and are ending. By this recirculation of funds, from higher-budgeted years to lower-budgeted years, the NIH continues to benefit through FY 2007 from the earlier 5-year doubling of the budget.
Dr. Zerhouni commented on another misconception—that pay lines are equal to success rates. He noted that success rates are always higher than the pay lines. And, because the number of applications per applicant has increased, the success rate understates the funding rate. The chances of an applicant being funded remain good and increases significantly when an applicant applies for funding over two review cycles. In FY 2006, the success rates for applications and applicants are approximately 20 percent and 25 percent, respectively.
Dr. Zerhouni emphasized that biomedical research is a long-term “marathon,” not a “100-meter dash.” Three strategies that the NIH and its constituents can take are: (i) know the facts; (ii) develop adaptive strategies—that is, protect the essential core mission of advancing knowledge and discovery, support new investigators, and increase the number of competing grants; and (iii) convey a unified message and communicate the NIH vision for the future. Support for new investigators (e.g., through the NIH Pathway to Independence Award program and other IC efforts) is critical.
Dr. Zerhouni encouraged the Council members to help educate the public—at local, regional, and national levels—about the positive impact of the NIH on science and health and the need to sustain biomedical research for the long term. He emphasized that NIH is an investment, not a cost, and that the return on this investment cannot be overstated. Americans are living longer and healthier.
For example—
The NIH investment in research on coronary heart disease has led to a 63 percent decrease in mortality, 1 million fewer early deaths (and $2.6 trillion in economic return), new effective treatments, more effective prevention (including successful reduction of cholesterol levels across the population), and new discoveries which industry is developing—all for a 30-year investment of $110 per American, or an average of about $3.70 each year per American.
The NIH investment in cancer research has resulted in 10 million cancer survivors, more effective detection and screening, the first decline (in 2003) in annual cancer deaths, an abundance of new minimally invasive treatments, and new discoveries making it possible to personalize cancer treatment—all for a 30-year investment of approximately $260 per American, or an average of about $8.60 each year per American.
The NIDCR investment in research has saved the American public more than $39 billion in dental expenditures during the 1970s and 1980s and, in 2006, 17.6 million adults are being spared the consequences of losing all their teeth. The investment per American has been minimal—approximately $21 over 30 years, for an average of about $0.70 per year.
Dr. Zerhouni concluded by noting that NIH’s continued support of basic, translational, and clinical research is transforming medicine from a curative to a pre-emptive approach. The medicine of the future increasingly will be predictive, personalized, pre-emptive, and participatory.
Discussion
Dr. Zerhouni remarked that Dr. Tabak has been an outstanding leader at the NIH. He also recognized, and the Council applauded, Dr. Dushanka V. Kleinman, Deputy Director, NIDCR, for her operational direction of the NIH Roadmap while on detail to the Office of the Director, NIH.
The Council thanked Dr. Zerhouni for his informative perspective on the NIH and suggested that his remarks could be distilled and combined with a statement of exciting directions for the future for broad dissemination in the mass media. In response to Council’s request for examples of NIH materials that could be used to educate the public about the NIH, Dr. Zerhouni offered to provide a copy of his slide presentation and referred the Council to the Web sites of the NIH and Office of the Director. Dr. Zerhouni noted that surveys show that only 11 percent of the American public knows about the importance of NIH. Dr. Christopher Fox, Executive Director, International and American Association for Dental Research, offered the support of these associations in distributing facts about the NIH.
The Council asked Dr. Zerhouni to comment on NIH support of training. He noted that the NIH supports approximately 17,000 research fellows and 50,000–60,000 research trainees and is giving emphasis to initiatives (e.g., the NIH Roadmap, clinical research training) that transcend and break down the barriers of traditional research disciplines.
VI. REPORT OF THE DIRECTOR, NIDCR
Dr. Tabak highlighted several items from his written Director’s Report, which was provided to Council and was made available at the meeting (see Attachment III). Details on these and additional items are provided in the written report. Dr. Tabak also presented a detailed “environmental scan” of NIDCR challenges and actions in FY 2005–06.
PHS/NIH Update
Dr. Tabak reported that Dr. Christopher G. Halliday became Chief Dental Officer, U.S. Public Health Service (PHS), effective on May 1. Dr. Kleinman, who has served as Chief Dental Officer since 2001, has returned to full-time duties at the NIDCR. Dr. Kleinman expressed her appreciation to Dr. Tabak and the NIDCR for supporting her efforts as Chief Dental Officer and her activities on the NIH Roadmap initiative.
Dr. Tabak noted that, for a select group of FOAs with receipt dates of May and June 2006, the NIH is giving applicants the option of designating more than one principal investigator (PI) for an individual research award. Based on the experience with these pilot initiatives, the NIH may offer this option for additional initiatives that have an October 2006 receipt date for applications. Ultimately, the NIH anticipates that the multiple-PI option will be available for all NIH awards.
NIDCR Update
On April 25, the NIDCR hosted its seventh Patient Advocates Forum. Dr. Tabak noted that this important meeting was attended by 17 patient advocates who represented 13 organizations having an interest in oral health and disease.
Dr. Tabak stated that the NIDCR will inform the Council about comments received on the development of the institute’s FY 2008 research initiatives. The NIDCR had invited individuals and organizations to provide input on the NIDCR Web site, and staff are now compiling the comments.
Dr. Tabak reported that the NIDCR and the National Heart, Lung, and Blood Institute have announced the availability of the Nutrition Data System for Research with Fluoride (NDS-R Fluoride), a software module to assess total fluoride exposure of humans from both dietary and non-dietary sources. This module was developed collaboratively by the U.S. Department of Agriculture’s Nutrient Data Laboratory and the University of Minnesota’s Nutrition Coordinating Center. Dr. Tabak noted that this software is suitable for a wide range of applications. He encouraged researchers to take advantage of this opportunity.
Science Advances
Dr. Tabak noted that NIDCR-supported research is receiving much media attention. In addition to the publications noted by Dr. Nowjack-Raymer (see section IV above), the Journal of the American Medical Association (April 18, 2006) published on the results of two NIDCR-supported randomized controlled trials. Both studies—in Europe and in the United States—evaluated the health effects of dental amalgam fillings in children. Each team of researchers concluded that children whose cavities were filled with dental amalgam had no adverse health effects.
Environmental Scan, FY 2005–06
Dr. Tabak described the NIDCR “environment” in FY 2000 and FY 2005, the “perfect-storm” realities for NIDCR, and how the NIDCR will exploit research opportunities during the challenging budget times ahead. He suggested that NIDCR’s actions over the past 5 years have prepared the institute for a “soft landing.”
Comparing FY 2005–06 and FY 2000. Dr. Tabak noted that, over the past 5 years, the NIDCR has altered its portfolio to reduce the proportion of funds allocated to program project grants (from 13 percent to 5 percent), centers (from 10 percent to 4 percent), and contracts, while maintaining strong support for research project grants (78 percent in FY 2005). During these years, the NIDCR acted to meet the specific challenges of increasing clinical and community-based research and enhancing the pool of oral health researchers.
In specific actions, the NIDCR issued a moratorium on unsolicited program project grants, refocused the centers program to address oral health disparities, discontinued many contracts, and increased the number of community-based Phase III clinical trials. In addition, the NIDCR launched practice-based research networks, participated in the NIH Pathways to Independence Award and Loan Repayment programs, and developed mechanisms to support the strengthening of research infrastructures in dental schools. The NIDCR also launched formal prospective and retrospective evaluations of its portfolio and realigned the Council’s operating procedures with NIDCR guiding principles.
Facing a “Perfect Storm.” Dr. Tabak provided estimates analogous to the data presented by Dr. Zerhouni when he spoke of the perfect storm facing the NIH. The NIDCR estimates show that the institute continues to uphold the traditional proportions of basic and applied research. In FY 2005, 43.9 percent of the NIDCR extramural budget supported basic research (compared with 46.3 percent in FY 2000), and 51.5 percent supported applied research (compared with 50.0 percent in FY 2000). Other research represented 4.3 percent (3.7 percent in FY 2000) of the extramural funds.
The proportion of unsolicited and solicited research grants parallels that of the NIH. In FY 2005, the proportion of unsolicited grants increased to 85.2 percent (from 78.6 percent in FY 2000), while the proportion of solicited grants decreased to 14.8 percent (from 21.4 percent in FY 2000). The “drivers” for the NIDCR are also the same as those for the NIH. As the number of new applications increases, the overall success rate decreases. In FY 2005, the NIDCR received approximately 650 applications, and the success rate was 37 percent. In the past 2 years (FY 2003–05), the NIDCR received 102 new applications—more than in all 5 years of the doubling of the NIH budget, when NIDCR received 79 new applications.
Dr. Tabak noted that, in comparison with the NIH and larger ICs, the recirculation of committed funds is more modest at the NIDCR and other smaller ICs. The annual turnover (i.e., available uncommitted funds) for research project grants averages 27 percent. In FY 2005, the turnover was 16 percent, compared with 24 percent in FY 2003.
Exploiting the Research Opportunities. Dr. Tabak remarked that the opportunities for research are extraordinary, as evident from the concepts presented for Council’s approval (see section IV above), and have perhaps never been greater before. To accommodate these opportunities, the NIDCR must proactively plan and prioritize. Guiding this effort are the NIDCR Strategic Plan and the NIDCR Implementation Plan for FY 2003–08, both of which were developed in consultation with the broad extramural community and many scientific working groups.
Dr. Tabak noted that the NIDCR will be more proactive in managing its portfolio. As set forth in the NIDCR FY 2006 extramural funding plan, which is posted on the NIDCR Web site, the NIDCR will consider factors “in addition to the rated scientific merit, as reflected in the priority score or percentile, in making funding decisions.” The factors will include “the need to fill significant scientific gaps in the institute’s research portfolio, potential scientific overlap with grants already supported, whether the applicant is a new investigator, and the level of other support available to the applicant.” Dr. Tabak noted further that the NIDCR will exercise additional flexibility in making funding decisions in order to be responsive to budget challenges, emerging public health issues, and new scientific opportunities.
Discussion
The Council expressed concern about the determination of “potential scientific overlap.” Dr. Tabak clarified that this factor is applicable to the rare instances in which the NIDCR is supporting many grants in one research area. The NIDCR program officers will identify areas of potential scientific overlap based on the CRISP database and the NIH coding of research grant applications.
The Council unanimously approved the following motion: “The Council fully supports the addition, as described by Dr. Tabak, and the clarity and articulation of other priorities” as set forth in the FY 2006 extramural funding plan.
VII. POSTER SESSION
The Division of Intramural Research hosted a poster session, and the Council had an opportunity to visit with NIDCR intramural investigators and discuss their research. The 14 posters covered a wide range of dental, oral, and craniofacial research. Most of the investigators who presented posters are combining experimental, laboratory investigations with genetic and animal studies to gain new insights into craniofacial development, salivary gland function, oral cancer, and pain responses.
In basic research studies of craniofacial development, the investigators are examining the functions of a cloned protein in the development of teeth and hair follicles, the role of an evolutionarily conserved protein modification in epithelial tube formation, and the activities of an important gene family of proteins involved in the formation of bones, teeth, and other organs. The studies of salivary gland function concerned molecular mechanisms regulating cell volume in salivary glands, structure-function studies of certain cotransporters and the roles of other proteins in fluid secretion and other biological processes, the function of a newly discovered protein in signal transduction and generation of cytokines, the transduction of proteins and pathogens across epithelial and endothelial barriers, and molecular mechanisms of cell migration and adhesion. One poster concerned the enzyme imbalances associated with malignant transformation of squamous epithelium, and two other posters addressed the mechanisms of inflammatory pain and the genetic variation leading to differences in individuals’ perception of pain.
In clinical research studies, the investigators presented posters on a longitudinal evaluation of disease progression and functional outcome in patients with fibrous dysplasia of bone, the susceptibility of tonsils to HIV entry and infection, and the mechanisms of gingival fibromatosis associated with mutation of the son of sevenless-1 (SOS1) gene.
CLOSED PORTION OF THE MEETING
This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
Before closing the session, Dr. Braveman presented the guidelines pertaining to confidentiality of information and materials presented and conflict of interest. He noted that members are required to absent themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.
The Chairman, Board of Scientific Counselors, reported on the results of the review of the Craniofacial Skeletal Diseases Branch, Division of Intramural Research, by the Board of Scientific Counselors in May 2005. The Scientific Director, NIDCR, presented the NIDCR response to this report.
VIII. REVIEW OF APPLICATIONS
Grant Review
The Council considered 588 applications requesting $201,577,408 in total costs. The Council recommended 457 applications for a total cost of $158,828,683 (see Attachment II).
ADJOURNMENT
The meeting was adjourned at 3:30 p.m. on May 22, 2006.
CERTIFICATION
I hereby certify that the foregoing minutes are accurate and complete.
________________________ _________________________
Dr. Lawrence A. Tabak Dr. Norman S. Braveman
Chairperson Executive Secretary
National Advisory Dental and National Advisory Dental and
Craniofacial Research Council Craniofacial Research Council
ATTACHMENTS
I. Roster of Council Members
II. Table of Council Actions
III. Director’s Report to the NADCRC, May 2006
NOTE: A complete set of open-portion handouts is available
from the Executive Secretary.