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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Institutes of Health
John E. Fogarty International Center
for Advanced Study in the Health Sciences
Minutes of the Advisory Board
Fifty-seventh Meeting
Table of Contents
Attendance
- Call to Order
- Consideration of Minutes of Previous Meeting
- Review of Requirements for Confidentiality and Conflict
of Interest Procedures
- Future Meeting Dates
- Report of the Director
- U.S. and Global Trends in Obesity
- Discussion
- Public Trust Initiative
- Closed Portion of the Meeting
- Review of Application
- Adjournment
The John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) convened the fifty-seventh meeting of its Advisory Board on Tuesday, May 18, 2004, at 8:40 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:40 a.m. to 12:20 p.m., followed by the closed session, from 1:00 p.m. to adjournment at 2:15 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.[1] Dr. Sharon Hrynkow, Acting Director, FIC, presided as chair.
Board Members Present:
Dr. Patricia M. Danzon
Dr. Wafaie Fawzi
Dr. Douglas C. Heimburger
Dr. Yvonne T. Maddox (ex officio)
Mr. Dikembe Mutombo
Dr. Sharon L. Ramey
Dr. Lee W. Riley
Dr. Stephen E. Straus (ex officio)
Dr. May L. Wykle
Board Members Absent:
Dr. Elizabeth Barrett-Connor
Dr. Robert R. Redfield
Dr. Burton H. Singer
Dr. Jean A. Wright
Members of the Public Present:
Professor Malegapuru Makgoba, University of Kwazulu-Natal, Durban, South Africa
Ms. Angela L. Sharpe, Consortium of Social Science Associations, Washington, D.C.
Federal Employees Present:
Ms. Nalini Anand, FIC/NIH
Mr. Andrew Jones, FIC/NIH
Mr. Kevin Bialy, FIC/NIH
Dr. Craig Jordan, NIDCD/NIH
Ms. Danielle Bielenstein, FIC/NIH
Dr. Richard M. Krause, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Dr. Flora Katz, FIC/NIH
Ms. Ania Burczynska, FIC/NIH
Ms. Judy Levin, FIC/NIH
Dr. Lois K. Cohen, NIDCR/NIH
Ms. Sonja Madera, FIC/NIH
Mr. Gregg Davis, FIC/NIH
Dr. Jeanne McDermott, FIC/NIH
Dr. Liza Dawson, FIC/NIH
Mr. Richard Miller, FIC/NIH
Dr. Sherry Dupere, CSR/NIH
Mr. Richard Millstein, FIC/NIH
Ms. Irene Edwards, FIC/NIH
Dr. Rachel Nugent, FIC/NIH
Mr. Robert Eiss, FIC/NIH
Mr. Mark Pineda, FIC/NIH
Ms. Megan Englehart, FIC/NIH
Ms. Charlotte Quinn, FIC/NIH
Dr. Jean Flagg-Newton, FIC/NIH
Ms. Minerva Rojo, FIC/NIH
Ms. Mollie Fletcher, FIC/NIH
Dr. Joshua Rosenthal, FIC/NIH
Dr. Pierce Gardner, FIC/NIH
Ms. Laura Rowe, FIC/NIH
Dr. Dan Gerendasy, CSR/NIH
Dr. Chris Schonwalder, FIC/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Dr. Hilary Sigmon, CSR/NIH
Dr. Karen Hofman, FIC/NIH
Dr. Allen Spiegel, NIDDK/NIH
Dr. Sharon Hrynkow, FIC/NIH
Dr. Sandy Warren, CSR/NIH
Dr. Dean Jamison, FIC/NIH
Ms. Brinah White, FIC/NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Sharon Hrynkow called the meeting to order and welcomed everyone. She introduced two new Board members: Dr. Patricia M. Danzon, University of Pennsylvania, Philadelphia, and Dr. Douglas C. Heimburger, University of Alabama at Birmingham. A third new Board member, Dr. Elizabeth Barrett-Connor, University of California, San Diego, was unable to attend.
Dr. Hrynkow introduced and welcomed two guests: Professor Malegapuru Makgoba, University of Kwazulu-Natal, Durban, South Africa, and Dr. Allen Spiegel, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH. Each gave presentations later during the meeting. Dr. Hrynkow also welcomed other NIH staff attending the meeting: Dr. Lois K. Cohen, National Institute of Dental and Craniofacial Research; Dr. Ruth Johnsson Hegyeli, National Heart, Lung, and Blood Institute; Dr. Craig Jordan, National Institute of Deafness and Communicative Disorders; and Drs. Hilary Sigmon and Sandy Warren, Center for Scientific Review.
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II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING
The minutes of the Advisory Board meeting of February 10, 2004, were considered and accepted unanimously.
III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES
The rules and regulations pertaining to conflict of interest were reviewed.
IV. FUTURE MEETING DATES
The following meeting dates were confirmed:
Tuesday, September 14, 2004
Tuesday, February 8, 2005
Tuesday, May 24, 2005
Tuesday, September 13, 2005
All meetings of the Research Awards subcommittee of the Board take place on the Monday preceding each Board meeting. Dr. Hrynkow invited the Board members to join the Research Awards Subcommittee.
V. REPORT OF THE DIRECTOR
Dr. Hrynkow reported on recent personnel changes, programs and initiatives, outreach activities, and new areas of interest at FIC. She asked staff to elaborate on selected topics, which included the budget, the Fogarty-Ellison Fellowship Program, the Global Forum on Bioethics in Research, and Medical Reporting and Communications. The written Report of the Director, which was mailed to Board members, is appended to these minutes as Attachment 2. Additional details on most of the items summarized below are provided in Attachment 2, Written Report of the Director.
Personnel Changes
Dr. Hrynkow introduced two new FIC staff members: Mr. Gregg Davis, Program Officer for East Asia and the Pacific, Division of International Relations, and Dr. Jean Flagg-Newton, Special Assistant, Office of the Director. Mr. Davis will be managing the very active Asia and Pacific regional portfolio, which includes interactions with Japan and China. Dr. Flagg-Newton, who previously served at FIC in 1995-1997 and who has rejoined as a Special Assistant in the Office of the Director, will work with visiting fellows from the developing world, the NIH Public Trust Initiative (see section VIII below), outreach, and other activities.
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FIC Budget
Dr. Hrynkow reported that the President's Budget for Fiscal Year (FY) 2005 requests $67.182 million for FIC. Congressional hearings on this budget were held in April on both the House and Senate side. Dr. Hrynkow's statement for the Congress in support of the FIC FY 2005 Congressional Justification was available at the meeting and is on the FIC web-site.
Richard Miller, Executive Officer, FIC, said that, in the coming months, the appropriations subcommittees in the House and Senate will mark up the bill and confer on their respective markups. With the upcoming presidential elections, the timing for completion of this budget is uncertain. Preparations for the FY 2006 budget have begun.
Programs and Initiatives
International Collaborative Trauma and Injury Research Training Program.
Dr. Hrynkow reported that FIC launched this new program on April 7, to coincide with World Health Day 2004, which focused on road safety around the world. The new program is FIC's "flagship" activity for FY 2005. The Program Announcement requests applications by August 25, 2004 (see http://grants.nih.gov/grants/guide/pa-files/PAR-04-83.html), and first-year awards will be made during FY 2005. The program was developed with broad consultation across the NIH and is co-sponsored by seven other NIH institutes and centers (ICs) and offices, including NIAAA, NIBIB, NINR, NIMH, NHBLI; OBSSR, and ORWH; the Centers for Disease Control and Prevention (CDC); the Pan American Health Organization; and the World Health Organization (WHO). The program is modeled on FIC's successful paradigm for research training that links U.S. and foreign institutions. It is expected that research training applications will be submitted in a range of areas, including development of synthetic blood products, mental health, consequences of domestic violence, long-term civil strife and in low-cost imaging strategies.
Fogarty-Ellison Fellowship Program in Global Health and Clinical Research.
Dr. Pierce Gardner, Senior Advisor for Clinical Research and Training, Office of the Director, FIC, reported on the status of this program, which was announced by the NIH Director, Dr. Elias Zerhouni, at FIC's 35th Anniversary Symposium in May 2003. Modeled on other successful FIC research training programs, and similar to the Howard Hughes Clinical Research Training Program, the Fogarty-Ellison Fellowship Program supports 1 year of mentored clinical research for U.S. medical and graduate students in the health professions at an NIH-funded research center in a developing country. The program consists of a 3-week orientation in clinical research at NIH and a 10-month or more clinical research experience in a selected site in a low- or middle-income country. The eligibility requirements are stringent, and FIC contracts with two organizations (the Association of American Medical Colleges and the Association of Schools of Public Health) to identify the best possible candidates through a national search. From a large applicant pool, 35 finalists were selected this year to come to NIH and, of these, 20 have been awarded fellowships and will go on to their foreign sites in July. Accompanying the fellowships is a grant to the foreign institution to support graduate studies and a stipend for a candidate at the foreign site who will collaborate with the U.S. fellow and the foreign clinical research team. The "twinning" component of the program is key. Enthusiasm for the program has encouraged FIC to plan to expand the number of sites from 14 to 18 and the number of candidates from 20 to 25-30 in 2005.
Partnership with the National Center on Minority Health and Health Disparities (NCMHD).
Dr. Hrynkow noted that FIC is partnering with NCMHD in a new effort to support U.S. minority students in the health sciences who wish to pursue international health research that addresses global health disparities relevant to minority populations in the United States. NCMHD has made a commitment to this effort for FY 2004 and FY 2005. NCMHD also will partner on other FIC programs, including the International Research Scientist Development Award, and provide support for U.S. doctoral students planning to study HIV/AIDS or other high-priority research in developing countries that is relevant to health disparities in the United States.
Sex, Gender, and Global Health Forum.
On April 27, the FIC hosted the "Forum on Exploring Potential Collaborations for Sex and Gender and Global Health Research." The event culminated 18 months of collaboration between FIC and the other forum sponsors: the NIH Office of Research on Women's Health, and the Institute on Gender and Health of the Canadian Institutes of Health Research. The participants included representatives from 18 NIH components, European groups, and foundations. The discussions led to a realization that the issue of gender and global health is often overlooked by agencies that fund science. The participants identified actions for advancing an agenda in this area. One action will be to provide input to the United Nations Education, Scientific, and Cultural Organization (UNESCO) for its annual report next year on science around the world, which will highlight the issue of gender.
Global Forum on Bioethics in Research.
Dr. Karen Hofman, Director, Division of Advanced Studies and Policy Analysis, FIC, reported that the 5th Global Forum was hosted by INSERM-France on April 22-23, 2004, in Paris, France. The topic was benefit sharing in the context of intellectual property. FIC presented cases addressing this topic and highlighting key issues from developing countries. The presentations stimulated a high level of discussion and enthusiasm among the researchers, ethicists, lawyers, and funders who attended. At least 80 of the 120 participants came from developing countries.
Medical Reporting and Communications.
Dr. Hofman reported on two FIC activities. In October 2003, FIC sponsored a workshop at NIH for Latin American and Latino health reporters to provide them an opportunity to meet with scientists and learn how to improve their reporting on health topics using the results of medical research. Twenty-five journalists were invited and attended, out of 100 who applied to attend. An evaluation indicated that the workshop was highly rewarding for the participants and resulted in almost 50 articles on global health research subsequently written or broadcast by the reporters using information or tools acquired at the workshop. The National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS), and National Library of Medicine (NLM) were strong NIH partners in this very positive effort. In FY 2004, FIC is "taking the show on the road" and plans to offer a workshop in Panama City, Panama. As before, the International Center for Journalists in Washington, D.C., will select the journalists who will attend.
Also with NLM and NIEHS, FIC is supporting four partnerships between medical journal editors in Ghana, Mali, Malawi, and Uganda and counterparts in the United Kingdom and United States. The aim is to enhance and improve the quality and content of medical journals in Sub-Saharan Africa and to address publishing issues. The Council of Science Editors in Arlington, Virginia, is the secretariat for this project.
Israeli-Palestine Authority Science Organization (IPSO).
Dr. Hrynkow stated that FIC is involved in early discussions to launch IPSO as a new organization that will fund small grants for Israeli scientists to collaborate with scientists from the Palestine Authority. FIC is providing advice and lending its expertise on small grants programs to this effort, which it supports intellectually and morally as a potential bridge for peace.
WHO Advisory Committee for Health Research.
Dr. Hrynkow noted that Dr. Elias Zerhouni, Director, NIH, asked FIC to represent NIH as an observer on this advisory committee to the Director General of WHO. Dr. Flora Katz, Program Officer, Division of International Training and Research (DITR), FIC, represented FIC at a recent meeting of the committee on May 3-5, 2004, at WHO headquarters in Geneva, Switzerland. She reported that the agenda included discussions of the World Health Report for 2004 (WHR2004); national health delivery and research systems; preparations for the Ministerial Summit on Health Research, which will be held in November 2004 in Mexico City, Mexico; follow-up on the previous World Health Report, which focused on genomics and world health; and regional committee reports. FIC has contributed to the intended WHR2004, which was meant to reflect an analysis of national health research systems. This material will now form a basis for a World Report on Knowledge, and the WHR2004 will focus on HIV/AIDS. The World Report on Knowledge, which will be presented to the ministers of health at the Ministerial Summit will contain case studies of successful applications of research results to health interventions. Dr. Katz noted that the regional committee reports emphasized the need for developing research capacity in WHO member countries and that FIC was singled out as a very good example of an organization that develops and funds research training programs.
Outreach Activities
Dr. Hrynkow noted that FIC is enlarging its outreach to inform others about FIC's mission, programs, and partnerships across the NIH to advance global health. In this effort, FIC will call on the Board for its wisdom and advice. Two recent activities are as follows.
"Global Health Matters" – The FIC Newsletter.
Dr. Hrynkow referred the Board to the second issue of FIC's newsletter, dated April 2004. She noted that, through this communication tool, FIC is able to "tell its story" and engage a variety of audiences on the importance of global health and FIC's efforts. She invited the Board to comment on how FIC could continue to improve the newsletter. It is available on FIC's web-site.
Emerging Issues of Global Health.
FIC is organizing a series of conversations, or "Town Hall" meetings, on global health, the first of which will take place with congressional members and staff. This activity arose from a roundtable hosted by Senator Jack Reed (D-Rhode Island) at Brown University on December 18, which is reported in the April 2004 issue of "Global Health Matters." On June 9, FIC will give a briefing at the Capitol at the invitation of Congressman Jim Langevin (D-Rhode Island) and in honor of former Congressman John E. Fogarty. This briefing will focus on mental disorders. Dr. Thomas Insel, Director, National Institute of Mental Health, and Dr. Nora Volkow, Director, National Institute on Drug Abuse, will participate with FIC.
New Areas of Interest
Dr. Hrynkow noted two new areas of growing interest for FIC: the NIH Public Trust Initiative, and research capacity building and schools of public health. The first area is described more fully below (see section VIII). With regard to the second area, FIC plans to convene a consultation with counterparts at CDC and deans of schools of public health to address the nexus between FIC's research training programs and schools of public health internationally. Dr. Hrynkow said that FIC has a continuing interest in supporting good scientific research that would translate into good public policy and improved health and that many of FIC's research training programs have led to the establishment of schools of public health in developing countries.
Dr. Hrynkow welcomed the Board's participation in the consultation and in working groups that FIC will establish to address these new areas of interest.
Discussion
The Board noted the exciting promise of the Fogarty-Ellison Fellowship Program and suggested that the foreign graduate students also attend the 3-week training at NIH. Dr. Hrynkow mentioned that other ICs are enthusiastic about the program and anticipate providing co-funding next year. The "twinning" of U.S. and foreign students is an important and valuable aspect.
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VI. U.S. AND GLOBAL TRENDS IN OBESITY
Dr. Hrynkow introduced the topic of obesity as one in which the FIC was taking an increasing interest. Three presenters offered different perspectives on the topic. Dr. Allen Spiegel, Director, NIDDK, described the NIH agenda for obesity research; Dr. Rachel Nugent, Program Officer, DITR, FIC, summarized obesity issues in developing countries, with a particular focus on economic issues; and Professor Malegapuru Makgoba, Interim Vice Chancellor and Principal, University of Kwazulu-Natal, Durban, South Africa, shared perspectives from South Africa.
NIH Agenda for Obesity Research
Dr. Spiegel emphasized that obesity is a global problem and that NIH views obesity as a health problem, rather than a moral or cosmetic problem. Obesity relates to the body's intricate system of homeostasis, or regulation, to maintain itself. Much as it regulates its temperature, the body also regulates its energy balance, or body weight. Data from the CDC's National Health and Nutrition Examination Survey (NHANES) show that obesity has increased tremendously in the United States between 1981 and 2001 and that 30 percent of U.S. residents are now obese-defined as a body mass index (BMI) of 30 or greater. The increase in obesity among boys and girls ages 12-19 is particularly seen among non-Hispanic black and Mexican American youth. Dr. Spiegel noted that the bases for these trends are not understood because energy intake and expenditure are measured using dietary questionnaires and other imprecise tools.
Obesity is a worldwide event and similar trends can be seen in other countries. Increased BMI tracks directly and steeply with increased morbidity and mortality. The health consequences of obesity are considerable [e.g., increased type 2 (adult-onset) diabetes mellitus in children, hypertension, dyslipidemia, atherosclerosis, cancer, sleep disorders, liver disease], and the costs for health care because of obesity are tremendous. Dr. Spiegel emphasized that the rise in diabetes mellitus portends a "disaster of major proportion" worldwide. Estimates indicate that 18.2 million U.S. residents (approximately 6.2 percent of the population) already have diabetes mellitus and that another 40.0 million have pre-diabetes mellitus, or impaired glucose tolerance. The global prevalence of diabetes mellitus was estimated at 2.8 percent in 2000. The projections of number of individuals with diabetes mellitus by 2030 are staggering; the highest are 11.3 million in Brazil, 42.3 million in China, and 79.4 million in India. A major concern is the recent dramatic increases in the incidence of diabetes mellitus among younger age groups.
Demographic data on shifts in body weight in the United States and elsewhere suggest economic factors that affect individuals' energy intake and expenditure. For example, changes in diet (e.g., increased consumption, poor selection of foods) may increase energy intake, and changes in lifestyles and residence (e.g., urbanization) may foster physical inactivity and decrease energy expenditure. In the United States, low income correlates with obesity (i.e., states with the lowest per capita income have the highest rates of obesity); agricultural policies tend to favor production and distribution of low-cost, calorie-dense foods; and urbanization continues to increase. These economic trends are troublesome and are relevant globally.
Obesity is, above all, a biological issue. As a classic gene-environment disease, the predisposing factors are genetic, as well as environmental. Asian populations, for example, are at risk of diabetes mellitus, but at much lower BMI levels–a finding that points to genetic or biological factors in the interplay between diabetes mellitus and obesity. Dr. Spiegel noted that, for survival, evolution favored energy storage to avoid starvation. But, "that was then and this is now." The number of surgeries being performed on young, morbidly obese individuals in the United States each year–a related biological issue–is indicative of the failure to balance energy intake and expenditure in modern times. And, because obesity is a polygenic disease, the susceptibility of individuals to it varies.
Unraveling the complexity of genetic and environmental factors involved in obesity and the interplay between them is a major research challenge. Dr. Spiegel noted that much research information is emerging on the metabolic activity and regulation of fat as an endocrine organ. Researchers are studying the incredible interplay among the brain, gut, and fat and other hormone-secreting endocrine organs (e.g., pancreas). They are validating the hypothalamus as the "feeding center" in the brain, and they are honing in on the role of leptin, a hormone secreted from fat, and other hormones. The possibilities for treating obesity in the United States include promotion of environmental changes, development of safe and effective medications, and development of agents that reduce food intake and increase energy expenditure.
Dr. Spiegel noted that NIH has published an "NIH Strategic Plan for Obesity Research" and established an NIH Obesity Research Task Force consisting of representatives from all the ICs. The aim is to develop the science base for understanding the physiological, behavioral, and broad environmental aspects of obesity and for preventing obesity. NIH is engaged in a bidirectional interplay with many others who are focusing on the complex problem of obesity. Dialogues are under way with other Federal agencies; biotechnology, pharmaceutical, food, and exercise industries; foundations and other non-profit organizations; and local and state governments.
Obesity Issues in Developing Countries
Dr. Nugent expanded on the discussion to note differences in obesity observed in developing countries. She commented further that comprehensive surveillance data are not available and studies exist only for a select group of countries. In middle-income developing countries, obesity is increasing across all socioeconomic groups and is concentrated in urban areas. In low-income developing countries, obesity is more concentrated among high-income urban populations, and it co-exists with under-nutrition sometimes even within a household. Obesity is increasing both because of changing diets and reduced physical activity. The exceptions are countries in Sub-Saharan Africa and South Asia, where under-nutrition is still dominant.
Dr. Nugent noted that the overall shift in global burden of disease to non-communicable, chronic diseases relates to overweight and obesity, but not in a 1:1 ratio in all regions. In all developing countries, the trends in overweight and obesity, patterns of increased fat consumption, urban-rural differences, and co-existence of over- and under-nutrition vary and are not well understood. In countries with high mortality rates, nutritional deficiencies contribute to the burden of infectious diseases, and in countries with low mortality rates, over-nutrition contributes to the burden of chronic diseases.
Dr. Nugent outlined several factors that clearly influence overweight and obesity in developing countries. These factors include the globalization of food systems (i.e., increased packaged foods, supermarket purchases); freer flow of labor, information, and technologies such as television (which intensify the marketing of products); changes in consumer behavior (e.g., eating outside the home, dietary preferences such as "fast foods"); and increased mechanization and urbanization (i.e., increased stress, social changes, physical inactivity).
Dr. Nugent reported that the Trans-NIH Subcommittee on International Nutrition Research is considering a range of research and research training efforts that would add to the knowledge base, including (a) research on behavioral interventions (e.g., to modify lifestyle risk factors); (b) collection of data on food composition in developing countries; (c) studies of body composition and measurement; (d) training and education to raise knowledge among health care professionals about the risk factors for overweight and obesity; (e) research on obesity and specific diseases in diverse populations; and (f) collection of data on the effects of agricultural and nutrition policies (e.g., price of food, manufacturing, distribution) on food producers' and consumers' behaviors.
Perspectives from South Africa
Professor Makgoba suggested that the United States is the "center of the world" in many ways and for many people and that it reflects its disparities and inequities. He noted that his own experience of growing up in South Africa illustrates some of the issues raised concerning overweight and obesity. Fifty years ago, as a young child in rural South Africa, he ate the staple food maize and one meal a day of meat or vegetables. Moving to the city at age 20, his pattern of eating changed-to three meals a day of three courses each.
Professor Makgoba affirmed that overweight and obesity are increasing problems in South Africa and Sub-Saharan Africa. He stated that data from the South African demographic health survey show that approximately 19 percent of adult males and 25 percent of adult females were overweight in 1998 and that the percentages are increasing. Highlighting the importance of social factors and cultural beliefs, Professor Makgoba noted that the least educated groups have the largest discrepancies between perceived and actual overweight-a finding that may relate to males' preferences for overweight women as an indicator of their ability to take care of their wives. Professor Makgoba also noted several other findings: Obesity is more common in the richer and more urban provinces of South Africa; white South Africans are most obese and black South Africans are least obese; and urban residents are slightly more overweight than are rural residents.
Among adolescents in South Africa, 17 percent of high school males were overweight and 9 percent were underweight in 2002, according to a risk behavior survey report issued by the South African Medical Research Council and National Department of Health. Professor Makgoba suggested that the mix of overweight and underweight may be common to developing societies undergoing socioeconomic transitions and differs from nutritional transitions in industrialized societies. The survey also showed that the co-existence of under-nutrition and overweight differed significantly among older and younger, male and female teenagers. For example, black female teenagers tended to be more stunted, but had a significantly higher prevalence of overweight, and overweight increased with age among both males and females.
Data on overweight among young children in South Africa are documented in two studies conducted by researchers at the University of Kwazulu-Natal. The first study, in 1994, showed that a significant proportion of rural schoolchildren ages 8-11 were overweight. The percentages ranged from 11.9 percent (based on the International Obesity Task Force's criteria) to 13.3 percent (based on governmental criteria). This study was extended to survey a larger population from 1994 to 2000. The findings showed that the proportion of children who were overweight was approximately 10 percent for children ages 8-11, but 5 to 24 percent for children ages 4-5.
Professor Makgoba remarked that these findings-in adults, adolescents, and young children in South Africa-are indicative of the magnitude of the global epidemic of obesity. He cautioned that approximately 8 percent to 9 percent of children in South Africa continue to have under-nutrition and that the effects of HIV/AIDS in children and adults may cloud the data on obesity, resulting in a "false sense" that populations are healthier than they really are.
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VII. DISCUSSION
The Board applauded FIC for its timely consideration of the worldwide epidemic of obesity. The members urged that the international dimension of obesity be added to the domestic research agenda outlined in the NIH Strategic Plan for Obesity Research. Dr. Spiegel agreed that NIH's initial focus on a domestic agenda for obesity research needed to be expanded with participation of public health and global health experts. The Board suggested that FIC could integrate its international interest in obesity into the NIH agenda by (a) identifying international research gaps in obesity that would complement the ICs' domestic efforts; (b) supporting training of foreign scientists in obesity research and epidemiology; (c) leveraging research funds from other ICs to support international research in obesity; and (d) including obesity research in the supplemental grant program. FIC already participates actively in the trans-NIH Obesity Research Task Force. Dr. Spiegel commented that he co-chairs the task force with Dr. Barbara Alving, Acting Director, National Heart, Lung, and Blood Institute. He suggested that international aspects of obesity will be included on the agenda of the next task force meeting.
In further discussion, the Board considered different aspects of obesity around the world. Members suggested several opportunities for international research related to obesity, which include: (i) comparative studies of Asians and Asian Americans to better understand genetic factors involved in the predisposition of Asian populations to diabetes mellitus; (ii) epidemiological studies to clarify genetic and environmental factors responsible for the high incidence of kidney disease in African populations; (iii) clinical research on the relationship among infections (including HIV/AIDS), high blood pressure, kidney disease, and diabetes mellitus in African populations; (iv) development of interventions to encourage individuals to visit doctors and participate in screenings for diabetes mellitus; (v) elucidation of the mental health dimension of obesity (i.e., depression, high anxiety, socialization) in research and treatment; and (vi) organization of public health and operational research programs to distribute effective medications (e.g., penicillin) for post-streptococcal nephritis, which is still common in some developing countries.
The Board pointed out that the current international emphasis on under-nutrition is not balanced by sufficient focus on obesity. For example, the Millennium Development Goals for nutrition target gains to be made in reducing the percentage of children worldwide who are underweight, but do not address overweight or obesity. Similarly, in developing countries that are emphasizing universal feeding programs for children, interventions may be inappropriate for some groups (e.g., children already in school or with a tendency to high weight for height).
The Board noted that, without effective interventions, the worldwide epidemic of obesity will become a pandemic. The members emphasized the need for early prevention and better understanding of all the factors (genetic and environmental) involved in obesity. The National Children's Study, which is being organized by the National Institute of Child Health and Human Development (NICHD), could offer a venue for addressing aspects of obesity in children (e.g., fetal antecedents of obesity) that would be relevant worldwide.
The Board reiterated the importance of economic factors in accounting for obesity in populations. Members emphasized the need for sound social, economic, and agricultural policies regarding food production and consumption. Through agricultural policies, the world's nations have an opportunity to promote the availability of healthier food and to reduce health and economic disparities between population groups. Other strategies, to give incentives to individuals to modify their eating behaviors, could have broad effects as well. Some approaches are being discussed with the U.S. Department of Agriculture and could be as effective as, for example, taxes on tobacco.
Dr. Hrynkow thanked the Board for its comments and enthusiastic support of FIC's interest in obesity research and research training and concluded the session with a statement that FIC would report back on progress in the near term.
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VIII. PUBLIC TRUST INITIATIVE
Dr. Yvonne T. Maddox, Deputy Director, NICHD, described the NIH Public Trust Initiative, which Dr. Zerhouni announced on April 28 at a meeting of the Council of Public Representatives (COPR), an advisory group to the Director, NIH. The goal of the initiative is to improve the public's health by promoting public trust in biomedical and behavioral research. Dr. Maddox and Dr. Patricia A. Grady, Director, National Institute of Nursing Research, are co-chairing the NIH steering committee for this large, complex initiative.
Dr. Maddox noted that the Public Trust Initiative is critical to accomplishing the NIH Roadmap and extends beyond the specific objectives of the roadmap to encapsulate all NIH activities. While acknowledging that NIH cannot control public perceptions of research, the NIH-a research organization-is taking this step to improve NIH's communication and interaction with the public. NIH defines the public in this case as individuals, patients, families, and communities, and it defines trust as the confidence placed by people in an institution or process.
The activities undertaken will be guided by two frameworks: (i) the research spectrum (i.e., the process of scientific research) and the public's interface with the research process, from discovery to communication, dissemination, and translation; and (ii) the NIH Roadmap (i.e., the three themes of re-engineering clinical research, research teams of the future, and new pathways to discovery). Initial efforts are already centered on obtaining a baseline of information, specifically (a) an inventory of NIH's ongoing and planned activities to enhance public trust and research related to public trust, and (b) a national survey of the public to discern issues regarding public trust and the research enterprise. Dr. Maddox noted that the ICs have been asked to provide initial inventory information by May 7 and that Research!America will develop and conduct the national survey in collaboration with the steering committee and COPR. The results of the inventory and survey will be used to develop specific solicitations and initiatives to close gaps in public trust.
Dr. Maddox anticipated that the initiative will lead to specific actions on important issues related to the public's trust, such as recruitment and retention of patients in clinical research, involvement of patient advocacy groups in clinical trials, use of researchers to disseminate and communicate research information, inclusion of women and minorities in clinical research, and assurance of ethical clinical research studies. An international perspective will be important and will be assured by FIC's participation on the steering committee. For this reason, the co-chairs invited Dr. Hrynkow to serve on the steering committee.
Dr. Maddox noted that public trust in biomedical and behavioral research and in researchers may be impeded by the perceived alignment of research with a health care system that many individuals in the United States do not trust. She highlighted the efforts of one community clinic in New York City that successfully combines public health care and research by involving diverse local populations in the front-end design of projects undertaken at the clinic. Drawing on this example, Dr. Maddox emphasized that "in order for the public to trust what we do, it has to be an integral part of what we do."
Discussion
The Board congratulated NIH for launching an exciting, timely, and important initiative. Members encouraged NIH to consider international and global perspectives of public trust and to draw on the NIH advisory committees, researchers, and policymakers that are contributing to NIH-supported international research. The Board cautioned that NIH should be careful to assure the public that this initiative is not a token effort and to avoid a potential backlash from the public when relating research to U.S. health care and medical treatments.
Dr. Hrynkow commented that, at the first meeting of the NIH steering committee, she pointed to the need for (i) discussions with science-funding agencies abroad to communicate NIH's interest, and to stimulate other governments' interest, in issues of public trust, and (ii) discussions with the various "publics" in developing countries. She encouraged the Board to advise FIC on international issues to present to the NIH steering committee, and she announced that FIC would lead an ad hoc working group to consider the international dimensions of public trust. In its reporting of activities for the NIH inventory, FIC included the "town-hall" meeting on Capitol Hill, the Global Forum on Bioethics in Research, and FIC's emphasis on obtaining input from developing countries as early as possible when developing new programs.
Staff noted that the lessons learned from successes and failures in promoting public trust in ongoing activities could be instructive for identifying "best practices" and planning future activities. Several lessons learned from FIC's international activities are the importance of benefit sharing with developing countries; accurate and timely science reporting; creation of sustainable, in-country research enterprises; and translation of research findings to improve health and health care in communities. Dr. Maddox noted that these international lessons are applicable to the United States as well.
IX. 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).
There was a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions, and recommendations. Members absented 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.
X. REVIEW OF APPLICATION
Mr. Richard Millstein, Acting Deputy Director, chaired the remainder of the meeting during which the Research Awards Subcommittee reported on its activities. The FIC Advisory Board reviewed a total of 74 scored competing applications at its May 18 meeting. [2]
19 applications for the Fogarty International Research Collaboration Award (FIRCA) program, out of a total of 79 applications, for $779,000;
14 applications for the AIDS International Training and Research Program (AITRP), out of a total of 28 applications, for $5,078,240;
18 applications for the Global Infectious Diseases Research Training Program, out of a total of 27 applications, for $1,811,327;
13 applications for the Informatics Training for Global Health (ITGH) Program, out of a total of 28 applications, for $1,947,373;
10 applications for the International Bioethics Education and Career Development Award program, out of a total of 23 applications, for $1,802,661.
The Board concurred with the initial review group recommendations for the 74 applications
XI. ADJOURNMENT
There being no further business, the meeting was adjourned at 2:15 p.m. on May 18, 2004.
[1] Members absent themselves from the meeting when the Board discusses 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.
[2] Applications that were noncompetitive or unscored or were not recommended for further consideration by initial review groups were not considered by the Council.
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