The John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) convened the fifty-third meeting of its Advisory Board on Tuesday, February 11, 2003, at 8:50 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 8:50 a.m. to 12:50 p.m., followed by the closed session, from 1:30 p.m. to adjournment at 3:00 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. Gerald T. Keusch, Director, FIC, presided as chair.  

Board Members Present:

Dr. Cutberto Garza
Dr. Yvonne T. Maddox (ex officio)
Dr. Sharon L. Ramey
Dr. Robert R. Redfield
Dr. Jaime Sepulveda
Dr. Robert E. Shope
Dr. Stephen E. Straus (ex officio)

Board Members Absent:

Mr. Dikembe Mutombo
Dr. Theodore Reich
Dr. Burton H. Singer
Dr. Catherine M. Wilfert

[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.

Members of the Public Present:

Ms. Nobayeni Dladla, Health Attaché, Embassy of South Africa, Washington, D.C.
Professor Michael Friedlander, Professor and Chairman, Department of Neurobiology, and Director, CIVITAN International Center, University of Alabama at Birmingham
Dr. Thor Haugstad, Head of Secretariat, Health and Values, Ministry of Health, Oslo, Norway Professor Are Holen, Head of Neurosciences, University of Trondheim Medical School, Norway
Dr. Jostein Mykletun, Science Counsellor, Royal Norwegian Embassy, Washington, D.C.
Professor Ursula Sonnewald, Neurobiology, University of Trondheim, Norway
Dr. Miriam Stewart, Scientific Director, Institute of Gender and Health, Canadian Institutes of Health Research, Edmonton, Alberta
Dr. William Tatum, Consortium of Social Science, Associations, Washington

Federal Employees Present:

OPEN PORTION OF THE MEETING

I. CALL TO ORDER

Dr. Gerald T. Keusch called the meeting to order.  He said that the agenda had changed because the three speakers initially invited were unable to attend the meeting.  Dr. Keusch noted that four new members had been appointed to the Advisory Board.  Two new members, Dr. Sharon L. Ramey and Dr. Robert R. Redfield, were in attendance, and two, Mr. Dikembe Mutombo and  Dr. Burton H. Singer, were unable to attend because of previous commitments.

Dr. Keusch welcomed and introduced the invited speakers for the meeting.  He also welcomed the following guests: Ms. Nobayeni Dladla, Embassy of South Africa, Washington, D.C.; Dr. Melinda Moore, Department of Health and Human Services (DHHS); Dr. Ross Cox, Centers for Disease Control and Prevention (CDC); Dr. Sandy Warren, Center for Scientific Review, NIH; and Dr. Tony Demsey, Office of Extramural Research, NIH.

Later during the meeting, Dr. Keusch welcomed and introduced the following attendees from Norway:  Professors Are Holen and Ursula Sonnewald, University of Trondheim; Dr. Thor Haugstad, Ministry of Health, Oslo; and Dr. Jostein Mykletun, Royal Norwegian Embassy, Washington, D.C.

II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING

The minutes of the Advisory Board meeting of September 10, 2002, 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 maintained.

IV. FUTURE MEETING DATES

The following meeting dates were confirmed:

                      Tuesday, May 20, 2003
                      Tuesday, September 16, 2003

                      Tuesday, February 10, 2004
                      Tuesday, May 18, 2004
                      Tuesday, September 14, 2004

All subcommittees of the Board will meet on the Monday preceding each Board meeting.

Dr. Keusch asked the Board members to inform Ms. Irene Edwards, Executive Secretary, of any scheduling conflicts they may have with the future dates.

Dr. Keusch highlighted the May 20 Board meeting.  In conjunction with this meeting, FIC is hosting a 1.5-day Symposium on Global Health to celebrate FIC’s 35^th anniversary.  The symposium will begin on the afternoon of May 20 and continue through May 21, with a dinner on the evening of the 20^th.  FIC is finalizing the agenda for the symposium and will be sending out invitations shortly

V. REPORT OF THE DIRECTOR

Dr. Keusch reported on personnel changes, the FIC budget, FIC 35^th anniversary events, and FIC programs and initiatives.  He invited staff members to elaborate on several activities.  The written Report of the Director, which was mailed to Board members, is appended to these minutes as Attachment 2, Written Report of the Director.

Personnel Announcements

Dr. Keusch reported that Dr. Greg Koski, Director, Office of Human Research Protections (OHRP), DHHS, left this position at the end of 2002 to return to Boston.  The Acting Director, OHRP, is Dr. Bernie Schwetz, who was previously at the National Institute of Environmental Health Sciences and Acting Deputy Commissioner of the Food and Drug Administration.  Dr. Keusch noted that FIC hopes to continue its close interactions with OHRP on international research ethics. Dr. James Lavery, Bioethicist, Division of Advanced Studies and Policy Analysis, FIC, is leading a team that has prepared a draft report on the issue of equivalent protections.

Dr. Ruth Kirschstein has stepped down as Deputy Director, NIH, but will continue in that role until a new deputy is appointed, when she will become a senior advisor to the director, NIH.  A search committee is actively seeking candidates for the deputy director position.  Dr. Wendy Baldwin left her position as Deputy Director NIH for Extramural Research (DDER) in January to become Vice President for Research at the University of Kentucky, Lexington.  Dr. Belinda Seto is the Acting DDER until a new director is identified.

Dr. Margaret Chesney, a former Board member, has been named the first Deputy Director, National Center for Complementary and Alternative Medicine.  Dr. Alan Guttmacher is the new Deputy Director, National Institute of Human Genome Research, succeeding Dr. Elke Jordan, who is now Associate Director for Scientific Initiatives at the Foundation for the NIH.  Dr. Thomas Insel is the new Director, National Institute of Mental Health; Dr. Ting-Kai Li is the new Director, National Institute of Alcohol Abuse and Alcoholism; and Dr. Nora Volkow has been appointed Director, National Institute on Drug Abuse.

Within FIC, Ms. Judy Levin is now the Program Officer for Africa and the Middle East, Division of International Relations (DIR).  Dr. Andrea Egan, who was Coordinator of the Multilateral Initiative on Malaria (MIM) Secretariat, left FIC to become Malaria Action Coalition Manager at Management Sciences for Health, Arlington, VA.  Dr. Keusch noted that the MIM Secretariat was transferred to Sweden on January 1, 2003.

  FIC Budget

Dr. Keusch noted that the ability to fund FIC programs is a critical issue for FIC.  Since October 1, 2002 [the beginning of Fiscal Year (FY) 2003], NIH, including FIC, has been operating on a Continuing Resolution, pending congressional action on an appropriation for FY 2003. Dr. Keusch asked Mr. Richard Miller, Executive Officer, FIC, to present an update on the status of the budget for FY 2003 and FY 2004.

FY 2003.  Mr. Miller said that the current (eighth) Continuing Resolution extends through February 20 and will possibly be replaced by another Continuing Resolution.  He noted that the President recently submitted an amended budget that requests the same total amount for NIH (approximately $27.2 billion).  The amended budget redirects some program funds to buildings and facilities to complete the Porter Neuroscience Center, resulting in a reduction for FIC of about $300,000 (to a total of about $63.1 million).  Mr. Miller commented that the Senate Full Appropriations Committee had taken action in July 2002 to increase the NIH total by $25 million, but in a recent Senate Omnibus Appropriations Bill for all government agencies, reduced this total back to the original President’s Budget and proposed a 2.6-2.9 percent across-the-board reduction in all discretionary programs.  The House Appropriations Committee never took official action on the original President’s Budget, although the subcommittee proposed to reduce the total NIH budget by about $700 million.

FY 2004.  The President's Budget for FY 2004 requests an overall 1.8 percent increase for NIH, to approximately $27.7 billion.  The budget request includes a 4.5 percent increase for non-AIDS research and a 4.0 percent increase for AIDS-related research.  With the completion of the funding in FY 2003 for the Clinical Research Center and the Porter Neuroscience Center, the funds were redirected to research programs.  The FIC budget would increase overall by 4.0 percent, to approximately $64.3 million; the increase for non-AIDS research would be about 2.8 percent and for AIDS-related research, about 6.2 percent.  Among the other institutes and centers (ICs), most would increase by 3.5-4.0 percent; the National Institute for Allergy and Infectious Diseases (NIAID) would increase by 8.9 percent (mainly in the area of biodefense); and the National Center for Research Resources would decrease by 1.0 percent, basically due to previous one-time funding for extramural construction.

For the Office of the Director, NIH, the President’s Budget requests an increase of 16.1 percent.  This increase would include $35 million for subsequent distribution to the ICs to support projects under the “NIH roadmap”—the planning exercise initiated by Dr. Elias Zerhouni, NIH Director.  The three areas of support under the roadmap are: New Pathways to Discovery—New Approaches and Technologies; Multidisciplinary Research Teams of the Future; and Re-engineering the Clinical Research Enterprise.  The ICs can submit projects in these areas and compete for the funding available.

Mr. Miller noted the program expansions and initiatives highlighted in FIC’s congressional justification for the FY 2004 budget.  These include support of full grants for the International Clinical, Operational, and Health Services Research Training Award program focused on HIV/AIDS and Tuberculosis (ICOHRTA-AIDS/TB) (to follow up on FIC planning grants awarded in FY 2002), pilot international “glue” grants, and initiatives to improve health and medical reporting, focus on gender issues in global health, train U.S. medical and public health students in clinical research in developing countries, and reduce the burden of ill health due to trauma and injuries.

  FIC 35th Anniversary Events

Dr. Keusch noted that the first two lectures in FIC’s year-long 35^th Anniversary Global Health Lecture Series have already taken place.  On October 28, Dr. Nevin Scrimshaw, Institute Professor Emeritus at the Massachusetts Institute of Technology and Senior Advisor to the Food and Nutrition Programme of the United Nations University, spoke on “Determinants of Global Health: Nutrition, Immunity, and Infection”; and on January 28, Dr. D.A. Henderson, Distinguished Service Professor at Johns Hopkins University and Director of Research and Development for the Office of Public Health Preparedness, DHHS, spoke on “Dreams and Realities in Disease Eradication.”  Four additional lectures are scheduled, including two in April and one in June and September (see Attachment 2 for the list of lecturers and topics).

For FIC’s Symposium on Global Health on May 20-21, FIC hopes to accomplish the following: a review of the role of research in improving global health, and a sensitization of the NIH community and the wider Capital area (including the Congress) to major global health issues.

  FIC Programs and Initiatives

Dr. Keusch highlighted some of the programs and initiatives described in the Report of the Director.  Additional comments are noted below.

AIDS International Training and Research Program (AITRP).  This program, which has been a major factor in creating capacity across the world to address the global AIDS epidemic, has been re-announced as a Program Announcement and will now be competed yearly, rather than every several years as in the past.  This change was made in recognition of the need to “ratchet up” training and capacity building in research in developing countries.  The FIC has engaged a number of IC cofunders for this program, and applications will now be accepted in March each year.

International Cooperative Biodiversity Groups.  This innovative program, which involves many cosponsors within NIH, as well as the National Science Foundation and the U.S. Department of Agriculture, is being recompeted.  Applications for funding in FY 2003 are due February 17.

International Collaborative Genetics Research Training Program.  This program is under way.  The FIC and seven NIH partners announced six development awards in October and expect that awardees will compete for the larger awards in 2 years.  In addition to training in genetic sciences, the projects will emphasize ethical, social, and legal implications of performing genetics research in low- and middle-income countries.

Health, Environment, and Economic Development (HEED) Program.  In partnership with other ICs and the U.S. Geological Survey, FIC issued a Request for Applications (RFA) in November for the first phase of the HEED program.  This program is designed to support research on the health implications of investments in economic development that have significant implications for the environment.

Global Health Research Initiative Program for New Foreign Investigators (GRIP).  This re-entry program is entering its second year, and FIC issued a second RFA in November.  During the first round of this popular competitive, investigator-initiated (RO1) program, FIC made 17 awards, out of 60 applications.  The program is aimed at building research capacity in low- and middle-income countries while supporting productive international collaborative relationships begun during the U.S. training period of the foreign investigator.

ICOHRTA-AIDS/TB.  FIC issued an RFA in early January for Phase II of this program, the large implementation grant which follows on the initial, Phase I planning grants.  The program requires a linked submission of applications from the developing country and developed country partners, and the awards are divided between the two institutions so that both have separate budgets and can function more as equal partners.

Brain Disorders in the Developing World: Research Across the Lifespan.  The RFA for this program, which involves many cosponsors, has been announced, and the receipt date for applications is March 11.  FIC has already received many letters of intent to apply.

Stigma and Global Health Research Program.  FIC received many applications in response to the RFA issued in August 2002, for support of interdisciplinary research on stigma in health and interventions to prevent or mitigate its effects. Applications were due November 14, and the review of them will begin shortly.

Fourth Global Forum on Bioethics in Research.  The fourth forum was held in Brasilia, Brazil, October 29-30.  Plans are under way for the fifth forum, which will be held in Paris, France, in May 2004.  The topic will be intellectual property and indigenous knowledge.  The partners sponsoring the forums will meet later in February to discuss achieving sustainable support for the forums in the future.  Dr. Keusch noted that the partners are very pleased that FIC initiated this extremely useful global activity.

Intellectual Property Rights.  FIC hosted a meeting of senior academic leaders and university technology transfer managers on December 11 to discuss the balance between the roles and responsibilities of universities as creators and disseminators of knowledge and the new role of entrepreneurs in generating patents, licensing, and revenues.  A followup to these discussions is being planned.

Gates Foundation “Grand Challenges” in Global Health.  The Bill and Melinda Gates Foundation announced on January 26 that it is giving $200 million to establish the Grand Challenges in Global Health Initiative in partnership with NIH.  This fund will support innovative new approaches for addressing the major challenges of global health.  The aim is to “think out of the box” and to fund new ideas, solicited through RFAs.  Dr. Harold Varmus, President, Memorial Sloan-Kettering Cancer Center, New York, and Dr. Richard Klausner, Executive Director of Global Health, Bill and Melinda Gates Foundation, will cochair the board that will guide and direct the initiative.  Other NIH members of the board, which is being assembled, include Dr. Zerhouni; Dr. Anthony Fauci, Director, NIAID; and Dr. Keusch.

Additional details on these and other activities are provided in the written Report of the Director.

  Canadian Institutes of Health Research (CIHR) and Gender IssuesI

Dr. Miriam Stewart, Scientific Director, Institute of Gender and Health (IGH), Canadian Institutes of Health Research (CIHR), Edmonton, Alberta, presented an overview of the CIHR and IGH organizations and activities.  Her remarks, which she made by telephone from Canada, were followed by comments from Dr. Sharon Hrynkow, Deputy Director, FIC, and Dr. Vivian Pinn, Director, Office of Research on Women’s Health (ORWH), NIH.  Copies of Dr. Stewart’s slides were made available to all attendees.

Dr. Keusch noted that FIC is cooperating with IGH and ORWH to review global health issues through the lens of sex and gender and to determine whether programs, initiatives, and interventions should be tailored based on sex and gender to be more effective in addressing chief determinants of health outcomes.  FIC and IGH initiated discussion of their shared interests in global health and gender issues in July 2002.

Overview of CIHR and IGH

Dr. Stewart emphasized that IGH addresses health issues across the lifespan of men and women, boys and girls. It is one of 13 institutes within CIHR, all of which take an integrated and interdisciplinary approach to health research and link, not only among themselves, but also to researchers across Canada, as well as internationally, to address health priorities.  Established just 2 years ago, CIHR is “breaking new ground” in a variety of fields and is embracing the full spectrum of health research, including the four pillars of this research—biomedical, clinical, population health, and health services and health systems research.  CIHR currently supports more than 7,000 researchers and students in Canada and, for its second year, received a $55 million increase in its budget.

CIHR’s four priority directions are to build Canada’s international leadership, improve the health status of vulnerable populations, integrate various disciplines, and strengthen health research and the health system.  IGH’s vision is to transform the understanding of the impact of gender (sociocultural) and sex (biological) on health across the lifespan and ensure its application in health research.  Its objectives are to generate evidence, advance the gender and health perspective, enhance research capacity, exert international impact, and provide evidence to inform programs, policies, and practice.  The five research priorities are: access and equity for vulnerable populations, promoting health in the context of chronic conditions and disabilities, gender and health across the lifespan, promoting positive health behaviors and preventing addictions, and gender and environment.

Dr. Stewart elaborated on IGH’s strategic initiatives in research and research training for each of the five research priorities during the past 2 years, as well as those foreseen for 2003-04.  Like NIH, IGH issues RFAs to solicit research applications.  In the past 2 years, IGH has supported more than 40 grants, 15 new interdisciplinary research teams, 28 research program development grants, 29 CIHR research training and career development awards, and more than 40 workshops, conferences, and symposia, including a national workshop for trainees and students.  An important activity is the fostering of research careers of women.  IGF staff are meeting with women scientists and policymakers in Canada, contributing to international and NIH conferences, and creating linkages with other funding agencies in Canada to enhance women’s research careers and decisionmaking.

During the next year, IGH anticipates action on the following strategic initiatives: reducing health disparities and promoting the health of vulnerable populations; global health; gender, globalization, and health; cardiovascular health; tobacco control; environmental influences on health; and ethics/privacy.  Dr. Stewart noted that, for these initiatives, IGH is partnering with other agencies in Canada and pursuing collaborations with NIH, including FIC.

CIHR/FIC/ORWH Collaboration 

Dr. Hrynkow described the conceptualization of a CIHR/FIC/ORWH collaboration on global health and gender issues.  She noted that CIHR/IGH’s vision of creating an evidence-based research agenda that is policy relevant is of particular interest to FIC and ORWH.  She and Dr. Pinn attended a planning meeting in Ottawa, Canada, in December 2002 to discuss the impetus needed to organize such a research agenda in gender and global health.  At this meeting, a decision was made to convene a series of four symposia during 2003 to explore and develop a research agenda in this area.

The first symposium will take place during the CIHR/FIC/ORWH-sponsored international meeting on the Impact of Global Issues on Women and Children, to be held February 16-21, 2003, in Bangkok, Thailand.  This symposium, which is entitled “Gender and Health in the Global Context,” is being organized by CIHR and will bring together approximately 100 invited experts.  The experts will discuss and synthesize the views expressed by researchers and health professionals who will have met earlier during the meeting in informal focus groups to comment on research priorities linking global health, globalization, sex, and gender.  The results of this symposium will “feed into” the next symposium, which will be held at Harvard University in April 2003 and will include policymakers who will be asked to comment on the potential research agenda.  The third and fourth symposia, which are being planned for June 2003 at Yale University and September 2003 in Canada, respectively, will “drill down” the research topics and distill “nuggets” likely to be of interest to science-funding agencies.  CIHR anticipates that the resulting research agenda will become a strategic research initiative, endorsed by international partners, which science-funding agencies could incorporate into their own programs or collaborate on together.

Dr. Hrynkow presented two slides prepared by Dr. Stewart showing major areas of overlap in activity and interest between IGH and ORWH and between IGH and FIC.  Some of the priorities shared by IGH and ORWH include mental health, reproductive health, and health across the lifespan.  Some of the priority initiatives shared by IGH and FIC include maternal and child health, environmental influences on health, mental health, and tobacco control.

Dr. Hrynkow noted that FIC staff have identified three broad areas of interest for FIC that would “dovetail” the needs of low- and middle-income countries and gender issues: (i) the role of gender in health and economic development and, perhaps, tobacco control; (ii) potential obstacles and ethical issues pertaining to the inclusion of women in clinical trials in these countries; and (iii) identification and development of methodologies for measuring the impact of research and interventions related to gender in these countries.  FIC would use research project grants to support efforts in these areas.  Dr. Hrynkow welcomed the input of the Board on these proposed directions.

The ORWH Perspective

Dr. Pinn elaborated on the concept within the context of NIH.  She noted that research on sex and gender has been a focus of ORWH activities from the beginning, when the office was established within the Office of the Director, NIH, in September 1990.  The focus for NIH has changed over time from an initial interest in women’s health as compared with men to sex and gender factors that contribute to differences in health among different populations of women and/or men.  For an evidence-based summary of current concepts and the importance of addressing sex and gender in biomedical research, Dr. Pinn referred the Board to her article, “Sex and Gender Factors in Medical Studies: Implications for Health in Clinical Practice,” which was published in the January 22-29, 2003, issue of the Journal of the American Medical Association (JAMA).  For further perspective on the scientific directives for this research, she referred the Board to an Institute of Medicine report entitled “Exploring the Biological Contributions to Human Health: Does Sex Matter?”

Dr. Pinn emphasized that research on sex and gender is important at NIH, and she noted that ORWH shares many of the same priorities as IGH.  Three overarching priorities for ORWH are research on sex and gender, interdisciplinary research, and interdisciplinary career development.  These priorities are fulfilled through collaboration with the ICs; ORWH does not directly fund any activities.  In addition to ORWH’s stimulation and coordination of research in these priority areas, NIH has instituted policies that stipulate inclusion of women and men and minority populations in clinical research, as required by the NIH Revitalization Act of 1993.  Thus, the results of all clinical research supported by NIH must include analysis of the contributions of gender, race, and ethnicity, unless there is a compelling justification or scientific reason for not doing so.

Dr. Pinn also noted that, for the past 4 years, ORWH has emphasized interdisciplinary research and interdisciplinary career development.  In collaboration with the ICs, ORWH has established two major programs: Building Interdisciplinary Careers in Women’s Health Research (BIRCH), and Specialized Centers of Research (SCOR).  The BIRCH program, which is administered by the National Institute of Child Health and Human Development (NICHD), supports the development of young investigators into mature, independently funded researchers in interdisciplinary, mentored research environments.  The SCOR program, which is funded by most of the ICs and administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), fosters interdisciplinary research among senior investigators.  In addition, ORWH has established a number of career development programs to increase the recruitment, retention, advancement, and retention of women in biomedical research careers.  One example is the Achieving Excellence in Science (AXXS) program.  The aim of this program is to encourage professional societies to support career development for women within their organizational structures.

Dr. Pinn emphasized that all ORWH programs include men, as well as women, and that ORWH aims to encourage both women and men to research sex and gender issues.  She congratulated Dr. Stewart on her accomplishments at IGH in such a short period of time, and she welcomed the opportunity to collaborate with CIHR/IGH and colleagues in other countries.  Dr. Pinn, who served on the FIC Advisory Board when she was first appointed to ORWH, noted that ORWH will continue to participate in international activities through and with FIC.

Discussion

Commenting on methodologies for evaluating the success of interventions, the Board urged FIC to not rely on conventional indices (e.g., mortality, burden of disease, life expectancy), but to seek measures (e.g., sociocultural, socioeconomic) that would clarify the (a) contribution of gender to the extent and distribution of health inequalities in populations and (b) the allocation of resources to gender-related health problems.  For low- and middle-income countries, some of the main gender-related health problems for which reliable measures and data are needed include cervical cancer, problems associated with development (e.g., breast cancer, smoking), and domestic violence.  Dr. Keusch noted that, through the Stigma and Global Health Research Program, FIC is beginning begin to address gender and sex issues.

CDC International Research Activities

Dr. David Fleming, Deputy Director for Science and Public Health, CDC, presented an update on CDC activities, elaborated on the agency’s international activities, and encouraged dialogue on enhancing CDC–NIH collaborations.  He noted that the partnership between CDC and NIH, and particularly with FIC on international health issues, is critical.

Dr. Fleming said that CDC currently is inundated with issues related to bioterrorism, the response to bioterrorism, and preparedness and that the need to focus on these issues while continuing to do other important work is creating many changes in CDC’s organizational culture.  The aim is to implement bioterrorism preparedness as efficiently as possible and in a way that improves CDC’s abilities in public health, both domestically and internationally, while continuing to recognize that this activity should only be a part of CDC’s activities.  Other important issues for CDC currently include obesity, asthma, and HIV/AIDS—domestically and internationally. Dr. Fleming noted that the President’s Budget for FY 2004 requests increased resources to address each of these issues.  He also noted that, like other Federal agencies, CDC faces a fluid budget scenario owing to the lack of an appropriation yet for FY 2003 and other stresses on the Federal budget.  Dr. Fleming commented that, with respect to international health, CDC has made tremendous progress in the past 2 years to enhance and strengthen its affiliations with United Nations organizations and recognizes the increasing need to engage in bilateral relationships—a priority at DHHS.

Dr. Fleming emphasized the importance of building on the complementary interests and strengths of CDC and FIC.  He suggested that the two organizations share a “push–pull” relationship with respect to research—NIH conducts and enables basic research, pushing this research into the field, while CDC conducts applied research, pulling it into health care delivery.  Two concrete areas where NIH and CDC overlap and where CDC is now receiving dedicated resources for international activity that could be coordinated with FIC are the (i) Global AIDS Program (GAP) and (ii) eradication of polio.

Dr. Fleming noted that key areas for collaboration as HIV/AIDS becomes a chronic-disease epidemic include (a) research and clinical trials of vaccines against HIV infection; (b) prevention of mother-to-child transmission (MTCT) of HIV/AIDS; and (c) care and treatment of people living with HIV/AIDS, especially in sub-Saharan Africa.  In these key areas, some collaborations are already under way, resources have been committed, applied programmatic questions need to be addressed, pilot projects need to be evaluated and brought to scale, and efforts to build research capacity and the infrastructure to support interventions are needed in developing countries.

With respect to eradication of polio, Dr. Fleming noted the great success of this international effort and highlighted three post-eradication challenges: containment, certification, and cessation of immunization.  Areas for collaborative research to sustain a polio-free world include (a) determining a scientifically sound strategy to discontinue vaccination with the live oral poliovirus vaccine (OPV), (b) identifying the size and components of an adequate vaccine stockpile, (c) evaluating the risk factors for and frequency of vaccine-derived polioviruses, (d) conducting a decision analysis of post-certification immunization policy options, (e) determining the immunogenicity of the inactivated poliovirus vaccine (IPV) in combination with other antigens, and (f) evaluating environmental surveillance for enhanced early detection of poliovirus outbreaks.

Dr. Fleming commented that international issues are increasingly becoming part of all CDC programs.  Additional examples of areas ripe for collaboration between CDC and FIC include research on the prevalence and control of tobacco use, diabetes, birth defects, and obesity.

In closing, Dr. Fleming said that CDC is embarking on a different approach under its new director, Dr. Julie Gerberding, to give emphasis and priority to developing a stronger applied public health research program both domestically and internationally.  CDC aims to model NIH’s success and, in collaboration with external partners, develop a process similar to that at NIH to support peer-initiated and peer-reviewed research.  Dr. Fleming noted that, in addition, CDC needs to work internally, to articulate its international program-driven research priorities, and collaboratively with NIH to agree on a joint research agenda.  He welcomed questions about CDC’s directions and encouraged FIC and the Board to engage in a dialogue with CDC on how to begin to take the next steps.

Discussion

Dr. Keusch noted that FIC and CDC are already collaborating in several areas of HIV/AIDS research: HIV/AIDS vaccine trials, MTCT of HIV/AIDS, and support of the ICOHRTA-AIDS/TB program.  Dr. Kenneth Bridbord, Director, Division of International Training and Research, FIC, noted that Dr. Fleming had suggested many excellent opportunities for collaboration.  Dr. Bridbord cited the following specific possibilities for FIC–CDC collaboration on HIV/AIDS research: (a) joint funding and review of an annual competing supplement award to leverage the investment in AITRP and the ICOHRTA-AIDS/TB by providing funds for trainees on their return to their home countries for work on CDC in-country programs; (b) designation of a CDC staff person to interface with FIC on the GAP (perhaps detailed to FIC on a rotating basis); and (c) assignment of a second-year CDC preventive medicine resident to FIC to foster FIC–CDC interface and expanded collaborations in tobacco control, infectious diseases, and environment and occupational health.

Dr. Keusch noted, in addition, that both FIC and CDC are committed to polio eradication and that FIC and CDC’s synergy on a research agenda for a post-eradication polio program could be exceedingly important.  He noted that Dr. D.A. Henderson addressed some of these issues in his lecture at FIC on January 28 as part of FIC’s 35^th Anniversary Global Health Lecture Series (see section V above).

The Board strongly encouraged collaboration between FIC and CDC on HIV/AIDS research.  Members noted that the recent enormous increase in resources available for interventions against HIV/AIDS, particularly for resource-poor areas and especially for sub-Saharan Africa, makes it critically important for the agencies of the U.S. Public Health Service (PHS) to optimize their ability to exploit each agency’s strengths.  The Board called, however, for a broad debate within the public health community about the potential effects (e.g., development of drug resistance) of implementing sub-optimal treatments.  The Board also cautioned against extrapolating the U.S. experience with HIV/AIDS treatment broadly to other countries where HIV/AIDS is complicated by other factors (e.g., multiple micronutrient deficiencies) and may have evolved differently in relation to reproductive roles and where individuals’ response to antiretroviral therapy is not yet known and may differ significantly from that in the United States.

The Board urged FIC and CDC to develop a “progressively collaborative” relationship and to combine their strengths with those of other PHS agencies to support strategic operational research on these types of issues.  At the same time, the Board cautioned the scientific community, in its enthusiasm for the new possibilities, to remember the primary axiom of medicine—“do no harm.”

The Board emphasized a number of related points, as follows.  (i) Investments in global health are investments in domestic health, and investments in human capital in developing countries have long-term benefits for the United States as well.  For example, CDC’s long-term investment in its Field Epidemiology Training Program in developing countries has been extraordinarily successful in fostering more secure public health surveillance systems in both developing countries and the United States.  (ii) To avoid competition and confusion, an organized channel is needed for investing all the monies that are becoming available for HIV/AIDS programs from various sources.  (iii) Institutions supporting HIV/AIDS programs should continue to strive for balance across their agendas, for HIV/AIDS is not the only health problem and should not overshadow other global health issues.  (iv) Emphasis should be given to FIC–CDC collaborations on in-country programs.  (v) The PHS should adopt a strategic, coordinated, and proportional response to HIV/AIDS and to the global health disparities that have widened over the past 20 years as a result of HIV/AIDS. (vi) The pandemic of HIV/AIDS offers an enormous opportunity for promoting global health as a foreign investment tool and for aligning health with foreign policy, economic, and security interests.  (vii) If the commitment to HIV/AIDS fails globally (e.g., because of drug resistance, poor management, inadequate coordination), the overall effort to promote global health will suffer enormously.

In closing, Dr. Fleming emphasized the need to further institutionalize the CDC–FIC relationship in order to promote more in-depth discussions.  One way would be to include FIC, as well as other U.S. interests, within CDC’s emerging concept of field stations that cover multiple disciplines, rather than categorical programs, focused on health problems (e.g., chronic diseases, environmental conditions) and building capacity in country.  He invited FIC to brainstorm with CDC to identify opportunities for applied research in other countries that could answer practical public health questions (e.g., the relationship between thimerosal and vaccines, whether the hepatitis A vaccine is protective post-exposure, the need for a booster for the hepatitis B vaccine).

Dr. Keusch reiterated that FIC and CDC already collaborate in several cofunded programs and that CDC is a partner in the Global Forum on Bioethics in Research.  He welcomed additional opportunities for interaction.

NICHD International Research Activities

Dr. Yvonne T. Maddox, Deputy Director, NICHD, described the mission and international activities of NICHD.  She noted that collaboration with FIC enables NICHD to learn more about global health needs and to translate the NICHD mission into practice in the global community.  NICHD is one of 27 appropriated entities at NIH.  Its broad mission, which crosses the lifespan, is to ensure that all children are born wanted, free from disease and disabilities, and grow into healthy and productive adults.  Established in 1964, the Institute will celebrate its 40^th anniversary in 2004.

Dr. Maddox said that international activities have been part of NICHD’s program since the beginning and were significantly expanded in 1998 when NICHD established its Office of International Affairs.  Dr. Danuta Krotoski is the Acting Director of the office.  Mr. Gray Handley, the first Director of the office, currently serves as Health Attaché in Pretoria, South Africa.  The many factors that led NICHD to establish the office included the Administration’s strong interest in the international arena, a recognition that this arena was going to be “the wave of the future” for health, the pressing biomedical and behavioral research questions that required international study, and receipt of the first award to a Federal agency from the Bill and Melinda Gates Foundation to organize a global network.  In April 2002, Dr. Maddox was part of the U.S. delegation led by Secretary Thompson that visited four countries in sub-Saharan Africa.  She noted that the devastation she saw on this visit accentuated for NICHD the importance of international programs, and the role of FIC, at NIH.

At the directive of Congress, NICHD has plans to launch a National Children’s Study (NCS).  This study will complement NICHD’s ongoing national program in children’s research issues.  The NCS will focus on diseases and conditions of poor health, as well as socioeconomic influences, and involves 100,000 children and their families.  NICHD is already developing feasibility data and has established working groups for the international study.

NICHD has identified areas of global need that are similar to those of domestic need.  The global needs include maternal and infant mortality, HIV/AIDS, contraceptive microbicides, nutrition and growth, reproductive health, learning disabilities (including mental retardation), and medical rehabilitation (associated with stroke, trauma, and brain injury).  Dr. Maddox referred the Board to the Pediatric, Adolescent, and Maternal AIDS Branch Report which was recently issued by NICHD and contains informative data indicating the type of impact that has been made against HIV/AIDS within the United States and can be made internationally.

Dr. Maddox noted that NICHD’s role internationally is similar to that of other ICs and organizations.  NICHD collaborates in a number of FIC training programs to address global health disparities, and this collaboration is continuous and sustained.  In addition, NICHD partners with FIC on major initiatives; NICHD and FIC cochair a trans-NIH committee on international nutrition research, for example.  Several NICHD researchers participate in multinational studies for clinical trials (e.g., in HIV/AIDS, children’s education).  NICHD investigators serve on multinational committees and boards, including those at the World Health Organization (WHO).  NICHD has established several bilateral agreements, including two with India (contraceptive and reproductive health, maternal and child health).

Most recently, NICHD is interacting with FIC on the Global Network for Research on Mothers and Children which was established by NICHD with the $15 million awarded by the Bill and Melinda Gates Foundation and matching funds provided by NICHD, for a total of $30 million to support 5-year projects in HIV/AIDS research.  The Institute has already funded 8 cooperative agreements (U awards) with research institutions in South America and sub-Saharan Africa and plans to fund another 4 in FY 2003, for a total of 12 sites.  Of the 12 sites, 5 will be cofunded with FIC which will support critically needed training activities, and other ICs are participating as well.In addition, NICHD is collaborating with FIC on a new program, Partnerships for HIV/AIDS Research in African Populations.  This initiative supports exploratory grants (R21s) and is an outcome of the NICHD–FIC meeting, entitled “A Consultation for a Research Agenda for Mothers and Children with HIV/AIDS,” which was held in Botswana in February 2001.  FIC is cofunding several of the grants.  The NICHD has also collaborated with FIC to issue several RFAs and to cofund awards resulting from these RFAs.

In closing, Dr. Maddox noted that NICHD’s support for international activities has grown from $564,000 in FY 1964 to approximately $69 million in FY 2001 (to support 269 extramural and intramural projects) and an estimated $73 million in FY 2002.  NICHD has contributed almost $1.4 million to FIC for cofunded projects.  NICHD investigators are involved in 60 countries either through direct grants or through the intramural program.  Dr. Maddox welcomed the opportunity to converse with FIC, other ICs, and CDC on developing a coherent research agenda that would maximize the resources available to sustain research projects.

Perspectives on NORWAY-U.S. Cooperation

Dr. Jostein Mykletun, Science Counsellor, Royal Norwegian Embassy, Washington, D.C., conveyed greetings from the Ambassador of Norway and summarized the Government of Norway’s current mission regarding health.  He said that the mission is to enhance medical science cooperation with the United States by building on the good medical tradition in Norway and linking up with the best in the world.  The Government of Norway wishes to raise the quality of medical science cooperation, create partnerships, and identify potential joint ventures.  Dr. Mykletun noted that Norway has a long tradition of foreign assistance to several countries, is proud of the priority it places on foreign assistance, and has integrated health and medical aspects with social equity and economic development throughout its foreign assistance policy.  He noted that Dr. Gro Brundtland, Director General, WHO, exemplifies this tradition and has carried it forward to WHO. 

Professor Michael Friedlander, Professor and Chairman, Department of Neurobiology, and Director, CIVITAN International Center, University of Alabama at Birmingham (UAB), described UAB’s collaborations with Norway and the tremendous opportunity now to form new partnerships with Norwegian scientists, particularly in the neurosciences.  He noted that an expanded UAB–Norway collaboration developed from ongoing individual research exchanges at the grassroots level and was stimulated by the Government of Norway’s current initiative to enhance medical science cooperation.  Of particular interest to UAB are the neurosciences and brain research.  In this area, UAB and Norwegian scientists are focusing especially on disenfranchised populations (e.g., those with developmental disorders, mental retardation, psychiatric disorders, diseases associated with aging, traumatic brain injury, drug addiction)—individuals who have little influence on the policies of their governments.

Professor Friedlander commented on the benefits of the collaboration for both UAB and Norway.  He noted that UAB’s neuroscience research is supported by many ICs and that this wide support enables UAB to offer colleagues in Norway a breadth of cutting-edge, modern research that crosses many disciplines.  For UAB, Norway offers outstanding investigators with a long tradition of excellence in neuroscience.  Norway is partnering with UAB on research conducted at UAB’s Civitan International Center, which is participating in the development of an application to the FIC program, Brain Disorders in the Developing World: Research Across the Lifespan.  Professor Friedlander noted that Norwegian scientists are also collaborating with investigators at Johns Hopkins University under an agreement with the Government of Norway to facilitate a wide range of biomedical research and training interactions.

UAB is informing the entire U.S. medical neuroscience community in departments of neuroscience at medical schools about the opportunities for collaborative research with Norwegian scientists and the availability of funding from private foundations in Norway, the Government of Norway, and Royal Norwegian Embassy in Washington, D.C.  In closing, Professor Friedlander emphasized the opportunity for significantly expanding international cooperation in neuroscience research and the possibility of having a major impact on the health and economies of the world by addressing brain-related disorders.

VI. 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.

  VII. REVIEW OF APPLICATIONS

	30 applications for the Fogarty International Research Collaboration Award (FIRCA) program, out of a total of 66 applications;
	8 applications for the HIV-AIDS and Related Illnesses Collaboration Award (AIDS-FIRCA) program, out of a total of 8 applications;
	3 applications for the International Centers of Excellence in Research, Clinical Research and Management Training Program Award (ICER), out of a total of 4 applications.

The Board concurred with the initial review group recommendations for the 41 applications.

VIII. ADJOURNMENT

There being no further business, the meeting was adjourned at 3:00 p.m. on February 11, 2003.