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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
Forty-third 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
- Development of Stable Isotope Nutrition Research Networks Through the International Atomic Energy Agency
- Is There a Role for Studies of Diet and Disease in Developing Countries?
- Closed Portion of the Meeting
- Review of Application
- Adjournment
The meeting of the Advisory Board of the John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) was convened on Tuesday, September 28, 1999, at 8:38 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 8:38 a.m. to 12:35 p.m., followed by the closed session for consideration of grant applications until adjournment at 2:00 p.m. Dr. Gerald T. Keusch presided as Chair.
Board Members Present:
Dr. Barry R. Bloom
Dr. Marvin Cassman
Dr. Margaret A. Chesney
Dr. Ezekiel J. Emanuel
Dr. Cutberto Garza
Dr. Samuel L. Katz
Dr. Mary Claire C. King
Dr. Cora B. Marrett
Dr. Patricia Marshall
Dr. Donald O. Nutter
Board Members Absent:
Dr. Francisco J. Ayala
Dr. Thomas W. Cole, Jr.
Dr. Rita R. Colwell
Dr. Steven E. Hyman
Mr. Thomas J. McAndrew
Members of the Public Present:
Dr. Carla R. Fjeld, Fjeld and Associates, Bethesda, Maryland
Ms. Pamela Moore, Capitol Publications, Inc., Alexandria, Virginia
Dr. Walter C. Willett, Harvard School of Public Health, Boston, Massachusetts
Federal Employees Present:
Dr. David E. Barmes, NIDCR/NIH
Dr. Josefa Ippolito-Shepherd, FIC/NIH
Mr. Amar Bhat, FIC/NIH
Dr. Gerald T. Keusch, FIC/NIH
Dr. Joel Breman, FIC/NIH
Ms. Sylvia B. Kniel, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Dr. Richard Krause, FIC/NIH
Dr. Virginia S. Cain, OBSSR/NIH
Ms. Jordana Land, FIC/NIH
Ms. Kathryn Chantry, FIC/NIH
Dr. Kathleen Michels, FIC/NIH
Ms. Irene Edwards, FIC/NIH
Dr. Mark Miller, FIC/NIH
Mr. Robert Eiss, FIC/NIH
Mr. Richard Miller, FIC/NIH
Ms. Mollie Fletcher, FIC/NIH
Ms. Sharon Nieberding, FIC/NIH
Ms. Eileen Gardner, FIC/NIH
Ms. Sherri Park, NICHD/NIH
Ms. Lee Ann Gschwind, FIC/NIH
Ms. Cynthia Palmer, FIC/NIH
Mr. F. Gray Handley, NICHD/NIH
Ms. Mary Plummer, NICHD/NIH
Dr. Kevin S. Hardwick, NIDCR/NIH
Dr. Joshua Rosenthal, FIC/NIH
Ms. Susan E. Harrison, FIC/NIH
Dr. Barbara Sina, FIC/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Ms. Rita Singer, FIC/NIH
Dr. Karen Hofman, FIC/NIH
Ms. Natalie Tomitch, FIC/NIH
Dr. Allen Holt, FIC/NIH
Dr. Sandy Warren, CSR/NIH
Dr. Sharon Hrynkow, FIC/NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Gerald T. Keusch, Director, FIC, called the open session of the Advisory Board meeting to order at 8:38 a.m. on Tuesday, September 28, 1999. He welcomed all attendees and introduced five new Board members: Dr. Barry Bloom, from Harvard University; Dr. Ezekiel Emanuel (ex officio), from the Warren Grant Magnusen Clinical Center, NIH; Dr. Cutberto Garza, from Cornell University; Dr. Mary Claire King, from the University of Washington; and Dr. Patricia Marshall, from Loyola University of Chicago. These new members bring to the Board expertise in global health, immunology, bioethics, nutrition, and genetics.
Dr. Keusch noted that the terms of three Board members will expire before the next Board meeting: Dr. Marvin Cassman, Dr. Rita R. Colwell, and Dr. Samuel L. Katz. He noted the special contributions of each member and presented each with a certificate of appreciation and an FIC T-shirt.
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II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING
The minutes of the Advisory Board meeting of May 18, 1999, were considered and accepted unanimously.
III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES
Dr. Keusch thanked the Board members for providing their updated Confidential Financial Disclosure Reports to the FIC.
IV. FUTURE MEETING DATES
The following meeting dates were confirmed:
Tuesday, February 8, 2000
Tuesday, May 16, 2000
Tuesday, September 19, 2000
The proposed meeting dates for 2001 are:
Tuesday, February 6, 2001
Tuesday, May 22, 2001
Tuesday, September 11
Dr. Keusch asked Board members to inform Ms. Irene Edwards, Executive Secretary, of any scheduling conflicts they may have with the future dates. All subcommittees of the Board will meet on the Monday preceding each Board meeting.
V. REPORT OF THE DIRECTOR
Dr. Keusch noted that he has served as FIC Director for approximately 1 year. He presented a summary of FIC's progress during this year and indications for the future. He related his remarks to the analogy of "building a house," a schema for charting FIC's directions that he introduced when he became FIC Director.
Dr. Keusch welcomed the Board's advice on FIC's directions and said that the FIC would be meeting later in the day with representatives of public groups and organizations to elicit their views of FIC and NIH international activities. The written Report of the Director was distributed previously to Board members, was available at the meeting, and is appended to these minutes as Attachment 2.
FIC's Mission and Foundation
Dr. Keusch noted that the platform, or mission, for FIC's "house" has been twofold: to build international research capacity and to create collaborative research networks. Within the past several months, the FIC has begun to explore the addition of a third component to this mission, to promote in-house FIC research relevant to the other components of the mission. For this activity, the FIC has recruited Dr. Mark Miller, formerly of the Centers for Disease Control and Prevention (CDC), to serve as FIC's Associate Director for Research.
The FIC continues to develop four fundamental areas that serve as the foundation for FIC's "house." These areas are medical informatics; bioethics; clinical research; and molecular genetics, genomics, and other basic sciences.
Medical Informatics. Dr. Keusch reported that the International Training in Medical Informatics (ITMI) Program was expanded during fiscal year (FY) 1999 to include funding for six new awards to support training of scientists from both sub-Saharan Africa (three awards) and Latin America (three awards) in specific research areas. Previously, the FIC collaborated with the National Institute of Allergy and Infectious Diseases (NIAID) and the National Library of Medicine to support four initial awards, for training of scientists from sub-Saharan Africa. Most of the new awards relate to infectious and chronic diseases. Dr. Keusch said that the FIC will continue to emphasize and develop this program.
Bioethics. FIC staff and Board members are participating in various activities to develop or revise international guidelines. Dr. Keusch noted that bioethics is on the "front burner" of international research issues globally and that, for the NIH, two concerns are paramount: ensuring international compliance with regulations for U.S.-funded research, and matching international guidelines to ethical and cultural realities of conducting research in developing countries. On June 21-22, 1999, the FIC convened a Workshop on Biomedical Considerations in Cross-Cultural Research. Held at the NIH, the workshop included 36 participants from international and national organizations and from developing countries. Reporting on the workshop, Dr. Patricia Marshall noted that the participants agreed on the following: current mechanisms in countries with transitional economies do not guarantee that a high level of ethics will be applied in implementing health research; an ongoing global bioethics forum should be established and should meet regularly in different host countries; and a long-term, multicenter initiative is needed to support training in bioethics. The first Global Bioethics Forum will be held in Washington, D.C., on November 7-10, 1999.
Dr. Karen Hofman, Special Expert, FIC, elaborated on the organization of the forum, which is being cosponsored by various NIH institutes, the World Health Organization (WHO), the Pan American Health Organization, and, potentially, The Wellcome Trust. The goal is to have 150 participants, with at least half from developing countries. Discussions during the first 2 days will focus on obligations of sponsors of research and obligations of host countries to communities where research takes place. On the third day, the participants will focus on training issues and the need for a long-term, multicenter training program in bioethics. Dr. Hofman noted that the response to the planning of the forum has been positive and enthusiastic. Dr. Keusch emphasized that the Global Bioethics Forum must be a global effort and that the FIC is playing a catalytic role to initiate the first forum. He anticipated that the Global Bioethics Forum will be a seminal event in the history of bioethics. The WHO, which strongly supports the effort, is organizing the second forum, to be held in 2000.
Clinical Research and Molecular Genetics. Dr. Keusch said that the FIC has included training in clinical research methodology in its FY 2001 budget request. During FY 2000, FIC discussions will relate to the needs for clinical research and clinical research training in developing countries. The genetics area also will be emphasized by the FIC as a target area for FY 2001. Three areas of interest to the FIC are clinical genetics (the identification of individuals, families, and populations for gene studies), postgenome functional genetics (linkage between genes, proteins, and disease establishment or progression), and regulation of gene expression (by factors such as environment and nutrition). FIC is discussing its interests in this area with other NIH components, which have been very receptive to the possibility of collaboration. Dr. Keusch said that the FIC highlighted the clinical research and genetics areas as priorities for FY 2001 at a budget forum for NIH institute and center directors, held in June.
Current Programs
Dr. Keusch said that the five current program areas are functioning extremely well. The program areas are: biodiversity, medical informatics, environmental and occupational health, population and demography, and HIV and emerging infectious diseases.
Within the last program area, the FIC has targeted malaria as a specific disease focus. Recently, the NIH assumed responsibility for the secretariat of the Multilateral Initiative on Malaria (MIM), and Dr. Varmus appointed FIC to the leadership of MIM, on behalf of the NIH. The aim of MIM is to foster research on malaria. With support from MIM's partners, WHO recently developed a program to support research and training in malaria in Africa. The NIH provides about $1 million a year, or about 50 percent of the funding, for this program, which is administered through WHO's Tropical Diseases Research and Training Programme. During FY 1999, the FIC also will provide $250,000 for supplements to malaria-related research grants supported by the FIC and NIAID. Dr. Keusch noted that these supplements are the beginning of a free-standing malaria program for the FIC. Currently, the U.S. Government allocates about $80 million each year for research on malaria; about half of these funds are provided by the NIH.
New Initiatives
The FIC seeks strategic alliances to launch and support its new initiatives. Partners include other NIH components and Federal agencies, foundations, WHO and other multilateral organizations, The World Bank, and the U.S. Agency for International Development. Dr. Keusch highlighted the following areas as new initiatives for FY 2000: health and economic development; environment, ecology, and infectious diseases; tobacco prevention and control; maternal and child health; and career development and minority training.
Health and Economic Development. To stimulate discussion of the connections between health and economic development in low-income countries, the FIC convened a Workshop on Health and Economic Development, held at the NIH on June 2. Dr. Cora B. Marrett represented the Board at the workshop as one of about 12 attendees. She reported that the participants engaged in a wide-ranging discussion and emphasized the need for collaborations across disciplines, sectors, and national boundaries. Principal themes included the possible aggregate effects of disease burden on income growth and gross national product; the association between health, climate, and geography; the contributions of public expenditure, participation, and governance on life expectancy; the importance of both equity and efficiency measures; and the need for improved metrics and mathematical tools. Dr. Marrett said that the participants unearthed a number of unresolved questions and that there is no shortage of potential topics for research. She noted that the participants were particularly enthusiastic about the possibilities for collaboration and were clearly willing to develop this initiative further with the FIC. Ways to advance the agenda might include new forms of collaboration, linkage of specific research topics to ongoing programs (e.g., at The World Bank), encouraging exchange of information, and continued improvement of measurement methods.
Dr. Keusch noted that the FIC is continuing to pursue this initiative in collaboration with The World Bank and WHO's new Council of Economic Advisors. Ms. Cynthia Palmer, Special Expert, FIC, reported on plans for a larger follow-up meeting, to be held at the NIH on November 15-16. Approximately 175 participants, including government officials and scientists from developing countries, are expected to attend this International Conference on Health and Economic Development. The aim is to identify and address research questions involved in the relationship between health and economic development. The FIC anticipates development and issuance of an RFA in FY 2000 for research and research training support under a transdisciplinary program in economic development and public health. This program is being developed to explore the intersection between economic, social, and biomedical factors and to develop tools and data sets to optimize the effectiveness of public health interventions in developing and transitional economies. The FIC hopes, in particular, to support linkages between NIH biomedical investigations and studies to model and measure household economic outcomes.
Environment, Ecology, and Infectious Diseases. Dr. Joshua Rosenthal, Program Manager for FIC programs in Biodiversity and Medical Informatics, Division of International Training and Research (DITR), reported on the Ecology of Infectious Disease program. Drawing on the recommendations of a workshop held at the NIH this past April, the FIC is completing a Request for Applications (RFA) which is expected to be issued by the end of October. With a commitment of about $4 million in funds from NIAID, the National Institute of General Medical Sciences (NIGMS), the National Institute of Environmental Health Sciences, the National Science Foundation, the U.S. Department of Agriculture (USDA), and the National Aeronautics and Space Administration, the FIC anticipates supporting eight 5-year investigator-initiated (R01) awards. The purpose of the program is to promote broad interdisciplinary research on the relationship between anthropogenic changes in the environment and the dynamics of infectious diseases. Integration of landscape-level analyses with focused bench studies will be encouraged. In discussion, the Board suggested that the FIC encourage inclusion of social and behavioral aspects of disease in this research.
Tobacco Prevention and Control. The FIC also has been developing a strategic alliance with the CDC and the WHO in tobacco prevention and control, a topic of increasing importance internationally. Dr. Keusch noted that estimates of the global burden of disease suggest that most deaths in developing countries in the next two to three decades will be smoking-related, but the research capacity in these countries to address this problem is limited. Working closely with the director of WHO's Tobacco Free Initiative, the FIC is addressing the possibility of developing a research training program in this area. On September 30, the FIC will convene a trans-NIH planning meeting to discuss the development of an NIH international research and training initiative for tobacco control. The FIC anticipates development of a training program tied to international research supported by the institutes. Specific linkages with the CDC and WHO also will be explored. In discussion, the Board noted the importance of social and behavioral aspects of tobacco control and suggested that the FIC encourage the NIH institutes to stimulate social and behavioral research in this area in collaboration with organizations (e.g., the Robert Wood Johnson Foundation) that are sponsoring multilevel interventions.
Maternal and Child Health. Dr. Kenneth Bridbord, Director, DITR, FIC, reported that 24 applications were received for the International Maternal and Child Health Research and Training (IMCHRT) Program, supported by the FIC in collaboration with the National Institute of Child Health and Human Development (NICHD). The applications have been reviewed and, with additional support from Dr. Varmus's discretionary fund and the Office of Research on Minority Health (ORMH), the FIC will be making seven awards in FY 1999.
Career Development and Minority Training. Dr. Keusch noted that the FIC has announced its support of four International Research Scientist Development Awards (K01s) in FY 1999. These 3-year awards are available to U.S. postdoctoral scientists who are committed to a career in international health research. The requirements include having strong mentors at both a U.S. institution and a foreign site and a commitment to spend at least 2 years at the foreign site. Awardees can apply for an additional 2 years of faculty support on their return to their home institution. Dr. Keusch noted that the FIC hopes to continue to develop and enlarge the program.
Dr. Barbara Sina, Health Scientist Administrator, FIC, reported that the FIC will be supporting 17 institutional Minority International Research and Training (MIRT) programs in FY 1999. Using some remaining funds, the FIC also will support the travel of about 15 students to an international ethnomedicine conference and another 20 students to an international AIDS meeting.
Future Prospects
Dr. Keusch highlighted three of the areas which the FIC is addressing for the future: nutrition, chronic diseases, and the research-policy interface. To help address FIC's role in nutrition research, Dr. Cutberto Garza was invited to join the Board and the meeting agenda includes two presentations on nutrition (see sections VI and VII below). As chronic diseases become more prominent with aging of the population, greater attention will need to be focused on them. As part of the NIH, FIC's concerns ultimately relate to the impact of research on health, that is, the interface between health research and policy. Dr. Keusch noted that the FIC is undertaking two activities in this regard. The first is FIC co-sponsorship, with the Pediatric AIDS Foundation, of a funder's conference, entitled "Synergy Between Research, Implementation, and Evaluation: A Paradigm Lost?," to be held at the NIH on December 14-15, 1999. The objective of the meeting is to reemphasize the importance of research in the context of implementation programs.
The second effort is the development of a plan for a study to assess the impact of NIH's international research investments over the past decade on science and health in the United States and countries where the research was conducted. The FIC has asked Dr. David J. Rothman, Professor of Social Medicine, Columbia University, to develop this plan for presentation to interested parties at the NIH. At a previous meeting of the Board, in February 1999, Dr. Rothman summarized the history of medical bioethics. Such an assessment will be useful for NIH planning and for NIH's participation in an international conference to be convened under the auspices of WHO, the Council on Health Research for Development, and the Global Forum, scheduled for October 2000 in Bangkok, Thailand.
Discussion
Dr. Marvin Cassman described several NIGMS activities related to FIC's initiatives. He noted that NIGMS recently convened two advisory committees which addressed ethical issues of research involving human populations. The first considered issues related to NIGMS's Chorio Cell Bank in Camden, New Jersey, which collects cell and DNA samples for distribution to researchers. The second set forth ethical guidelines for population-based studies; the report of this committee will be disseminated to the Board. In FY 1999, NIGMS also launched a new pharmacogenetics initiative to support research on the underlying molecular mechanisms involved in individuals' different responses to drugs. Based on the recommendations of a group of public representatives convened by NIGMS to comment on this initiative, NIGMS established a variety of focus groups to better understand the public's concerns with population-based research. Dr. Cassman also noted that NIGMS has one of the largest NIH programs for increasing the participation of underrepresented minorities in research. Recently, NIGMS and the Indian Health Service cosponsored a meeting to specifically address ways of improving the participation of Native Americans in research; the report of this meeting will be disseminated to the Board. Dr. Keusch noted that the FIC has been discussing with ORMH the organization of a research ethics course for participants in FIC's MIRT Program.
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VI. DEVELOPMENT OF STABLE ISOTOPE NUTRITION RESEARCH NETWORKS THROUGH THE INTERNATIONAL ATOMIC ENERGY AGENCY
Dr. Carla R. Fjeld, Fjeld and Associates, Bethesda, Maryland, summarized the characteristics and advantages of a nutrition research network and some of the "lessons learned" about strategies for successful networks. She drew on her experience from organizing programs for the International Atomic Energy Agency (IAEA) in which high-tech research methodologies were applied to address basic problems in nutrition in developing countries. Dr. Fjeld said that the IAEA has a mandate to transfer and support the peaceful use of nuclear techniques to its member countries and, in that context, supports various studies on nutrition using isotopic techniques in developing countries.
In one IAEA program, an international network of nutrition researchers from Guatemala, India, Jamaica, Malawi, Pakistan, Peru, and the United States jointly developed, implemented, and evaluated a generic research protocol that involved the use of stable isotopes to measure the effect of unhygienic environments on health and disease. The main hypothesis for the study was that subclinical infection, associated with unhygienic environments, alters the way in which the body uses amino acids for protein synthesis. Findings showed that, under conditions of marginal nutrition, muscle protein is broken down at rates required to provide amino acid building blocks for new protein synthesis. This and other studies of nutrition are described in an IAEA publication entitled Targeting Malnutrition, Isotopic Tools for Evaluating Nutrition Worldwide (96-02531 IAEA/PI/A48E, July 1996).
The opportunity to develop networks among researchers and between researchers and their respective governments arose from an untimely budget cut for a research program which Dr. Fjeld had come to the IAEA to organize. To regain funding, the perceived value of the program had to be enhanced for a heterogeneous group of decision-makers (engineers, physicists, and government planners) around the world. The key was to focus on outcomes that would be perceived as relevant by these decision-makers for their countries and regions. A new paradigm was needed, and networks became a key component.
Dr. Fjeld defined a network as a continuum of interaction, from information exchange to collaborative research, that builds on a division of labor and the comparative advantages of each member of the network. The aims of the IAEA international networks were expanded from applying scientific tools for research to understand the challenges to applying research outcomes to human health within the context of physical, social, and political environments.
Two important benefits of the networks were their ability to adapt the protocols to the particular needs of each site and their role in developing solidarity among scientists and between scientists and policymakers at these sites. There were many challenges, including how to measure program impact and accomplishments and how to relate findings to health policymaking.
Some of the "lessons learned" from overcoming these challenges are as follows. Generic protocols developed jointly with scientists in developing countries build capacity; science-based programs may remain an "island" if the larger social, cultural, economic, and political context is not considered; research programs to improve health must include links to policymakers and other important constituencies; programs should include a protocol for evaluating the economic impact of the program and the reduction in global burden of disease; and the institutional capacity for change varies among organizations. Dr. Fjeld emphasized that factors such as human well-being and growth mediate long-term consequences of economic investments in developing countries and must be a component of development initiatives in order to maximize the benefits of these investments.
Based on the understanding gained from the international network studies, subsequent IAEA activities, conducted mainly in Latin America, have partnered nutrition and health with other sectors of development (e.g., energy, education, social welfare). They also have become increasingly demand driven, focusing on the needs of the country and thereby catalyzing greater participation of scientists in national and regional policy development. Capacity building (e.g., joint development of protocols and methodology) is receiving greater attention, and evaluation of a program's effect is performed jointly by north-south participants and by nutrition, economic, and development experts.
In closing, Dr. Fjeld noted that the research networks have not been the only step necessary for switching from purely science-based programs to broader efforts to improve health and quality of life, but they have been extremely important for capturing information, strengthening the participation of scientists in developing countries' programs and policies, and monitoring local changes.
VII. IS THERE A ROLE FOR STUDIES OF DIET AND DISEASE IN DEVELOPING COUNTRIES?
Dr. Walter C. Willett, Chair, Department of Nutrition, Harvard School of Public Health, Boston, Massachusetts, reviewed data on the relationship between diet and disease, obtained from studies in developed countries, and commented on the advantages of large cohort studies for clarifying this relationship. He noted that researchers have traditionally viewed nutrition in developing countries as a problem of malnutrition and deficiencies of well-recognized micronutrients (e.g., iron, iodine). He emphasized that the scope of this research needs to be expanded significantly in response to the projected major increases in deaths from noncommunicable (chronic) diseases in these countries, accompanied by a decline in deaths from communicable diseases and overt nutritional problems.
Few data are available on the relationship between diet and disease in developing countries. The two major sources of information in developed countries are the Nurses' Health Study, beginning in 1976 and including more than 121,000 participants, and the Health Professionals Follow-up Study, beginning in 1986 and including 52,000 participants. Dr. Willett noted that dietary data are being collected in both studies and indicate major nutritional problems in both populations, even though they are relatively well-nourished and educated about nutrition. The studies also have demonstrated the usefulness of a simple, structured, food intake questionnaire as a method for measuring the nutrient intake of individuals.
Reviewing findings from the studies, Dr. Willett noted the positive effects of various foods and supplements in reducing risk of disease (e.g., folic acid, for colon or breast cancer, and spinach, for cataracts); the relationship among genes, diet, and disease (e.g., colorectal cancer and genetic polymorphisms affecting the metabolism of folic acid); and the detrimental effects of specific foods (e.g., trans fatty acids or high-glycemic and low-fiber foods, for coronary heart disease and non insulin-dependent diabetes mellitus). Dr. Willett noted that coronary heart disease rates are increasing dramatically in developing countries, concomitant with increased intake of trans fatty acids (e.g., in vegetable ghee, inexpensive cooking oils) and reduced levels of physical activity, which can make individuals more susceptible to the effects of foods with a high glycemic load.
Dr. Willett cautioned that the standard medical model used in the United States to prevent diet-related diseases (e.g., use of statin drugs to prevent potentially fatal coronary heart disease) is a costly approach with very modest results, usually benefiting only those at very high risk. A 12-year follow-up of 90,000 women in the Nurses' Health Study indicates that diet is relevant to prevention of chronic disease. For example, over 80 percent of coronary heart disease can be readily prevented by diet, exercise, and not smoking. The follow-up also showed a lack of relationship between onset of major chronic disease and the high Healthy Eating Index, a "yardstick" developed by USDA for nutritional programs in the United States, suggesting that current U.S. dietary guidelines may be misleading.
Commenting on undernutrition among children, Dr. Willett noted that community-based studies have shown that vitamin A supplementation can substantially reduce infant mortality in some circumstances and is an important variable to consider in addition to height and weight for children who do not have overt signs of nutritional deficiency. An active program is now under way internationally to address the role of micronutrients in relation to mortality and other health outcomes. Careful analysis of food components will be needed to clarify the associations found between food intake, as documented in dietary questionnaires, and risk of disease and mortality.
In sum, the data obtained from well populations indicate that the varied nutritional intakes of individuals in developing countries are likely to have major consequences for the development of chronic diseases and for childhood mortality, particularly from infectious disease. Investigations of large population cohorts could help identify the major determinants of morbidity and mortality, evaluate the impact of policy recommendations and interventions, and identify subgroups for more detailed studies and trials. Large cohort studies also would provide a resource for research training and create a focus for multidisciplinary research. Dr. Willett noted that although such investigations may be expensive, they are cost effective in comparison to the support of numerous, unconnected small studies.
Currently, at least 33 large cohort studies are being conducted internationally. They range in size from 6,000 to 500,000 participants, for a total of about 3 million individuals in 18 different countries, and include collection of blood samples from more than 800,000 persons. Dr. Willett noted, however, that no countries from Africa, Latin America, or South Asia are participating in these studies. Major issues in designing these studies relate to the selection of populations to study, the inclusion of biological specimens, follow-up mechanisms, and funding.
DISCUSSION
The Board emphasized the importance of having accurate scientific data, integrating research and policymaking in the application of science to improve health, and understanding the "science" of information dissemination to the public. The Board noted that women's magazines are a primary source of public information on nutrition and preventive medicine, although these subjects are being incorporated into the medical school curriculum. It was suggested that the FIC could foster the translation of technical information to the public by supporting fellowships for the training of journalists.
Dr. Keusch asked for comment on the appropriateness for the FIC of the two models of study presented by the speakers: high-tech studies of small population groups, and low-tech studies of large population cohorts. Drs. Fjeld and Willett agreed that emphasis should be given to identifying priority health questions and then selecting the technology and approach that would be most useful and appropriate for addressing each question.
VIII. 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.
IX. REVIEW OF APPLICATION
A total of 91 applications requesting $10,821,167 in FY 1999 funds were reviewed by the FIC Advisory Board as follows:
7 applications for Senior International Fellowship (SIF) awards requesting $239,500;
25 applications for Fogarty International Research Collaboration Awards (FIRCAs) requesting $885,731;
3 applications for AIDS-FIRCA awards requesting $131,815;
26 applications for MIRT awards requesting $5,001,603;
16 applications for IMCHRT awards requesting $3,035,834;
7 applications for ITMI awards requesting $999,078; and
7 applications for K01 awards requesting $527,606.
The Board concurred with the initial review group recommendations for 91 proposals, recommending $10,821,167.
X. ADJOURNMENT
The meeting was adjourned at 2:00 p.m. on September 28, 1999.
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