September 14, 2004 Meeting Minutes

Public Health Service
National Institutes of Health
John E. Fogarty International Center
for Advanced Study in the Health Sciences

Board Members Present:

Dr. Wafaie Fawzi
Dr. Douglas C. Heimburger
Dr. Yvonne T. Maddox (ex officio)
Dr. Sharon L. Ramey
Dr. Robert R. Redfield
Dr. Stephen E. Straus (ex officio)
Dr. May L. Wykle
Dr. Jean A. Wright

Board Members Absent:

Dr. Elizabeth Barrett-Connor
Dr. Patricia M. Danzon
Mr. Dikembe Mutombo
Dr. Lee W. Riley
Dr. Burton H. Singer

Members of the Public Present:

Dr. Nelson Sewankambo, Dean, Faculty of Medicine, Makerere University, Uganda
Ms. Shirley Haley, Managing Editor, Washington Fax, Washington, DC
Ms. Nobayeni Dladla, Health Attache, Embassy of South Africa, Washington, DC
Ms. Mary Woolley, President, Research! America, Alexandria, VA

Federal Employees Present:

Dr. Amar Bhat, OGHA/DHHS
Ms. Leslie Magnuson, FIC/NIH
Mr. Kevin Bialy, FIC/NIH
Ms. Alisa A. McCullar, FIC/NIH
Dr. Joel Breman, FIC/NIH
Dr. Kathy Michels, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Dr. Mark Miller, FIC/NIH
Mr. Bruce Butrum, FIC/NIH
Mr. Richard Miller, FIC/NIH
Dr. Ana Chepelinsky, FIC/NIH
Mr. Richard Millstein, FIC/NIH
Mr. Robert Eiss, FIC/NIH
Ms. Sherri Park, NICHD/NIH
Dr. Anthony Fauci, NIAID/NIH
Dr. Aron Primack, FIC/NIH
Dr. Jean Flagg-Newton, FIC/NIH
Ms. Charlotte Quinn, FIC/NIH
Dr. Henry Francis, FIC/NIH
Dr. Joshua Rosenthal, FIC/NIH
Dr. Pierce Gardner, FIC/NIH
Ms. Julia Royall, FIC/NIH
Dr. Dan Gerendasy, CSR/NIH
Dr. Lone Simonsen, NIAID/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Dr. Barbara Sina, FIC/NIH
Dr. Karen Hofman, FIC/NIH
Ms. Natalie Tomitch, FIC/NIH
Mr. George Herrfurth, FIC/NIH
Dr. Sandy Warren, CSR/NIH
Dr. Sharon Hrynkow, FIC/NIH
Ms. Helen Wegman, NHLBI/NIH
Mr. Andrew Jones, FIC/NIH
Mr. Randolph Williams, FIC/NIH
Ms. Patricia Jordan-Williams, FIC/NIH
Dr. Flora Katz, FIC/NIH
Dr. Linda Kupfer, FIC/NIH
Ms. Sonja Madera, FIC/NIH

Personnel Changes

Dr. Hrynkow reported that FIC has used a new approach to bring staff members to FIC's Division of International Relations (DIR), namely to identify NIH staff members interested in gaining international experience through an assignment at FIC. At the same time, FIC gains insights and experience from the categorical institutes. Dr. Hrynkow introduced two individuals from other NIH components who recently joined FIC as DIR program officers: Dr. Henry "Skip" Francis, from the National Institute of Drug Abuse (NIDA), who is providing leadership for FIC's Sub-Saharan Africa portfolio, and Dr. Ana Chepelinsky, from the National Eye Institute, who is providing leadership for FIC's Latin America and Caribbean portfolio. A third individual, Dr. Zakir Bengali, from the CSR, has responsibility for FIC's South Asia portfolio and is currently in India on behalf of FIC.

Ms. Minerva Rojo, director of DIR, is on detail to the Office of the Director, NIH, to assess policies and practices related to dual-use technologies worldwide. Mr. Richard Millstein, Acting Deputy Director, FIC, served as Acting Director, DIR, in June-August, and Mr. Rob Eiss, Senior Advisor for Strategic Initiatives, FIC, is serving as Acting Director, DIR, in September.

Dr. Richard M. Krause, Senior Scientific Advisor, FIC, and National Institute of Allergy and Infectious Diseases (NIAID), has taken on an assignment to lead the newly established Regional Emerging Disease Intervention (REDI) Centre in Singapore until a permanent director is identified. The REDI Centre, a joint activity between the Singapore Ministry of Health and DHHS, will develop training in infectious disease surveillance and foster collaborative research in the region.

FIC Budget

Mr. Richard Miller, Executive Officer, FIC, reported on the status of the FIC budget. The President's Budget for Fiscal Year (FY) 2005 requests approximately $67.1 million for FIC, an increase of $1.8 million over the approximately $65.3 million appropriated in FY 2004. Mr. Miller noted that the Senate Appropriations Committee has not yet acted on the President's Budget request and that the House Appropriations Committee has provided the same amount as in the President's Budget. The full House is just beginning its appropriations debate. When FY 2005 begins, on October 1, 2004, the NIH expects to be operating on a continuing resolution.

Congressional Items

Dr. Hrynkow noted that Dr. Elias Zerhouni, Director, NIH, has devoted significant attention in the past months to working with Congress on the issue of conflict of interest. This issue is urgent and important for NIH, and policies concerning conflict of interest are evolving. Dr. Hrynkow emphasized that the ongoing discussions affect every NIH Institute and Center (IC).

On June 28, at the invitation of the Rhode Island delegation and Congressman Jim Langevin, in particular, FIC participated in a Capitol Hill briefing on global health. The specific focus of the briefing was the global burden of mental illness and approaches to address the burden through NIH activities. Dr. Hrynkow was joined at the briefing by Dr. Richard Nakamura, Deputy Director, National Institute of Mental Health, Dr. Nora Volkow, Director, NIDA, and an FIC grantee, Dr. Eric Caine, University of Rochester, to give presentations on "The Silent Epidemic of Mental Disorders: The Growing Global Burden." Dr. Hrynkow noted that Senators Chafee and Reed and Congressman Kennedy and Langevin showed great interest in and support for FIC activities and that the event resulted in requests for FIC information from various other offices on Capitol Hill.

Programs and Initiatives

Global Health Research

Ms. Woolley elaborated on data indicating the public's knowledge and attitudes about global health issues. These data were collected in spring 2004 in a survey commissioned by Research! America with support from the Ellison Foundation. The data indicate that the American public is aware of differences in the leading causes of death in the United States compared with poor or developing countries (for the latter, 70 percent cited malnutrition and famine and 51 percent cited HIV/AIDS as the first and second leading causes of death, respectively). Most of the Americans surveyed (61 percent) said they are somewhat familiar with health problems facing the world and almost one-half said they are concerned about these problems--findings that indicate opportunities for advocacy for global health research. The survey respondents expressed concern about infectious diseases (specifically, HIV/AIDS, influenza, tuberculosis, and Severe Acute Respiratory Syndrome, or SARS) as a first priority, and most of the respondents (81 percent) strongly or somewhat agreed that infectious diseases cannot be contained within national borders and thus are a problem for all countries.

Among the respondents, 35 percent cited medical and health research as a top priority for U.S. Government spending around the world. Disease prevention is a priority for Americans, as evident from the percentage of respondents who cited the following efforts as a somewhat or top priority for U.S. Government spending around the world: education (86 percent), medical and health research (82 percent), training of doctors and health professionals (81 percent), and provision of health care services (70 percent). More than three-fourths of the respondents said that the United States should be involved in improving health around the world because it is a world leader in scientific expertise and medical research; the same proportion noted that improving health will prevent future health crises. The smallest percentage (52 percent) said that improving health would help in the fight against the terrorism and political instability.

When asked about U.S. spending for global health research, 71 percent of the respondents said that one cent on every one dollar is too little, and 25 percent said that the United States should spend more than 10 cents on every one dollar (19 percent said between six cents and nine cents). Ms. Woolley suggested that these findings indicate that the public would support substantial increases in funding for global health research.

Ms. Woolley noted that other survey data complement the findings of the Research! America survey. For example, data collected in the Pew Global Attitudes Project show that AIDS and infectious diseases is a top concern globally (in 17 of 44 countries). Pointedly, the Pew data also show that the perceived greatest threat to the world varies widely--for example, nuclear weapons is cited most often in the United States, whereas infectious diseases/AIDS is cited most often in Africa. The Pew data were collected in interviews of 38,000 individuals in 44 countries and are presented in a report entitled What the World Thinks in 2002 (The Pew Research Center, December 2002).

What Can Researchers Do?

Ms. Woolley emphasized that researchers must be accessible and accountable to the public. They can foster public support of health and medical research by assuming the role of "citizen scientist" and inviting the public to communicate and converse with them about their research. An effective message is: "I work for you." Researchers could talk with the public about the value of research in improving global health, give examples of research that supports global health, and link their examples to the public's top concerns. Researchers also could develop alliances with voluntary health organizations, which are skilled in making the case for research and have enormous political power. Researchers must value engagement with the public and find ways to foster and reward researchers who engage the public.

As The Honorable John Edward Porter said, when recently speaking to scientists, "...your voice, your effort, your participation...are essential and vitally needed to influence positively the public policies affecting science." And, as The Honorable Paul G. Rogers emphasized during FIC's 35th Anniversary Symposium, "Without research, there is no hope."

Discussion

Ms. Woolley encouraged the Board members to access poll data and other material on Research! America's web-site at www.researchamerica.org . Dr. Hrynkow noted the excellent data and practical wisdom developed by Research! America should be made available to all FIC grantees and trainees. Ms. Woolley noted that accountability is a great concern among the public, and she encouraged all stakeholders in the research enterprise to acknowledge this concern and to communicate examples of researchers' being accountable to the public. Elaborating on public trust issues, Ms. Woolley highlighted the role of voluntary health organizations in communicating to patients the success and challenges of research and need for the media to inform the public about opportunities to participate in clinical trials and research. Additional data are needed to clarify the reasons for the large difference between the percentage of Americans willing to support clinical research (approximately 65 percent) and the percentage willing to participate in this research (approximately 50 percent). Public participation in clinical research and in decision making on the design and conduct of research must be valued.

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HIV/AIDS

One of the greatest scourges of history, HIV/AIDS already is responsible for 23 million deaths worldwide. In 2003 alone, the number of new infections approached five million and the number of deaths approached three million. Two-thirds of the people living with HIV/AIDS (PLWHA) reside in Sub-Saharan Africa, and the next epicenter is likely to be in Asian countries (e.g., China, India) where even a small percentage affected can be tens of millions of people. In the United States, almost 900,000 cases and approximately 500,000 deaths have been reported through 2002, and almost one million are PLWHA. The 12-year plateau of new infections continues, one at which approximately 40,000 new cases of HIV are diagnosed each year, with one-half under age 25.

The funding for research on antiretroviral (ARV) treatment has had high payoffs, and the Food and Drug Administration (FDA) has approved more than 20 ARVs--more than for all other viruses combined. Because of the availability of treatments, the number of PLWHA will continue to increase. A major issue globally is the disparity in access to treatments, as highlighted at the 14th International AIDS Conference, in Durban, South Africa, in 2000. While 84 percent of PLWHA in the United States are receiving the drugs they need, only two percent of those in Africa are. Dr. Fauci noted that this disparity is rapidly changing, largely because of three collaborative mechanisms: the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria; the President's Emergency Plan for AIDS Relief (PEPFAR); and bilateral agreements with non-governmental organizations (NGOs).

Dr. Fauci noted the need for a comprehensive strategy of prevention for HIV disease that includes prevention of mother-to-child transmission, education and behavioral modification, and use of condoms. He also emphasized the importance and difficulty of developing an effective vaccine. Obstacles in this effort are operational, social, and financial, and the most significant factor is the uniqueness of the microbe and scientists' inability to delineate correlates of immunity. To accelerate development of a preventive vaccine, researchers are organizing the virtual Global HIV Vaccine Enterprise, first described in Science in June 2003. Dr. Fauci noted that collaboration, cooperation, and transparency are essential in all international health efforts.

Malaria

For decades, malaria has been a major cause of morbidity and mortality globally, with 1.5 million to 2.7 million deaths annually and 300-500 million new infections each year. Every 30 seconds, a child dies from malaria. Dr. Fauci noted that scientists have sequenced the genomes of the three acting partners in malaria: Plasmodium falciparum, the major microbial species causing malaria; the vector mosquito; and humans. The challenge now is to use the genomic tools available to translate findings in the functional genomics of malaria to diagnostics, therapeutics, and vaccines.

TB

An estimated one-third of the world's population is infected with TB; a new infection occurs every second; nine million individuals develop active TB each year; and 300,000 new cases of multidrug-resistant TB arise each year. In 2002 alone, eight million individuals died of TB. Dr. Fauci noted that, for the first time in 60 years, trials of new candidate vaccines for TB are under way.

Influenza

Influenza is perhaps the most worrisome emerging and re-emerging infection. The annual burden of influenza is very high globally. In the United States alone, approximately 200,000 individuals are hospitalized with influenza each year and 36,000 die from influenza each year. The threat of a major pandemic is ever present and could result in more than 500,000 deaths in the United States, as occurred in the influenza pandemic of 1918-19. The possibilities of a major antigenic shift or a jumping of species (e.g., from birds to humans, as with H5N1) are great concerns. Dr. Fauci noted that companies have not been given adequate incentives to develop products such as vaccines, which have low economic payoffs, and that NIAID is becoming very actively involved in "pushing the envelope" for development of influenza vaccines.

SARS

The combination of epidemiology research and public health measures to identify the microbe responsible for SARS and to control its transmission is an extraordinary success story. This microbe has been held in check since the first year when it emerged and caused 8,000 cases and 800 deaths. Yet, the underlying conditions of human-animal interactions are essentially the same and scientists must remain vigilant and maintain their collaboration, cooperation, and transparency in confronting this disease. Dr. Fauci noted that researchers have created animal models, established correlates of immunity, and developed vaccines that are protective in mice.

West Nile Virus

This virus has appeared in almost every U.S. state since first identified in 1999. In 2004, more than 1,300 U.S. residents were diagnosed with West Nile Virus and 35 individuals died from the disease through September 10. The virus illustrates well the fundamental epidemiology principles of infectious diseases--emerging from a combination of the "right host," the "right vector," and the "right conditions" to spread predictably over time and place. Dr. Fauci noted that scientists have used clever approaches to advance toward developing a vaccine against West Nile Virus. They are testing chimeric vaccines in a Phase I clinical trial, with more trials planned, and have launched a treatment trial involving 60 U.S. sites and use of passive transfusion of antibodies from individuals who have been exposed and recovered from West Nile Virus.

Bioterrorism Agents--Anthrax

Dr. Fauci noted that the September 11 attack and the subsequent deliberate spread of anthrax in letters mailed in the United States galvanized U.S. attention on the vulnerability of its population to bioterrorism and fostered greater appreciation of naturally occurring emerging and re-emerging infections. The NIAID and other ICs realized an enormous boost in NIH funding (greater than $1.5 billion each year from FY 2003 and FY 2005) for fundamental basic and applied research on biodefense, and NIAID prepared the NIAID Strategic Plan for Biodefense Research and research agendas for category A agents and for category B and C agents. NIAID has argued that biodefense research and research priorities must span, and must be incorporated into, the full intellectual spectrum of research on emerging and re-emerging infections, from basic to applied and translational research and to product development.

To stimulate research across the spectrum and to expand the physical capabilities for this research, NIH funded eight Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research. Dr. Fauci noted that the research in these centers and in related NIAID and IC programs focuses on the three key countermeasures against infectious diseases: diagnostics, therapeutics, and vaccines. Already, researchers are making significant advances, for example, in developing safe vaccines against smallpox that could be used in all segments of the population and against Ebola Virus and anthrax.

In closing, Dr. Fauci commented that increased funds for biodefense have been a boon for public health. He referred the Board to Dr. Krause's 1981 book, The Restless Tide: The Persistent Challenge of the Micobial World (Washington, D.C.: The National Foundation of Infectious Diseases), which made the point, now long understood, that humans and microbes will never be able to completely eliminate each other. To maintain the delicate balance, humans must rely on their wits, scientific capability, and commitment to public health and biomedical research.

Discussion

Dr. Fauci noted that the infusion of funds for biodefense not only is having an impact on research and research training supported by NIH, but also is being used by DHHS to strengthen the public health infrastructure in the United States, including at state and local levels. Dr. Hrynkow thanked Dr. Fauci and NIAID for their past and continuing support of FIC's research and research training programs. She noted that these programs are helping to provide the "bedrock" for many public health infrastructures worldwide. Dr. Fauci noted that FIC is intimately connected with the broad global issue of emerging and re-emerging infectious diseases and that NIH's strategic plan and research agenda for biodefense offer an umbrella and a door for FIC's continued efforts in this area.

In response to questions, Dr. Fauci highlighted the experience with SARS as an excellent model for international collaboration, cooperation, and transparency on global health issues. He noted that chronic diseases are also major global health issues and that NIAID is partnering with other ICs and the World Health Organization to consider possible links between infectious diseases and chronic diseases such as cancer and cardiovascular disease. Dr. Fauci said that NIAID is enthusiastic about placing his staff in key countries to serve full-time as international representatives "on the ground" (similar to CDC's in-country representatives). He noted that this action is essential, but will be difficult to accomplish given the current limitations on the NIH budget.

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Abbreviations Used in the Minutes

AIDS

Acquired Immunodeficiency Syndrome

AITRP

AIDS International Training and Research Program

ARV

Antiretroviral

CDC

Centers for Disease Control and Prevention

CSR

Center for Scientific Review

DHHS

U.S. Department of Health and Human Services

DIEPS

Division of International Epidemiology and Population Studies

DIR

Division of International Relations

FDA

Food and Drug Administration

FIC

John E. Fogarty International Center for Advanced Study in the Health Sciences

FIRCA

Fogarty International Research Collaboration Award

FY

Fiscal Year

HIV

Human immunodeficiency virus

ICs

Institutes and Centers

IRSDA

International Research Scientist Development Award

ISHED

International Studies on Health and Economic Development

ITREID

International Training and Research in Emerging Infectious Disease

NCI

National Cancer Institute

NCMHD

National Center on Minority Health and Health Disparities

NGOs

Non-governmental organizations

NHLBI

National Heart, Lung, and Blood Institute

NIAID

National Institute of Allergy and Infectious Diseases

NICHD

National Institute of Child Health and Human Development

NIDA

National Institute on Drug Abuse

NIEHS

National Institute of Environmental Health Sciences

NIH

National Institutes of Health

OGHA

Office of Global Health Affairs

PEPFAR

President's Emergency Plan for AIDS Relief

PLWHA

People living with HIV/AIDS

REDI

Regional Emerging Disease Intervention (Centre)

SARS

Severe Acute Respiratory Syndrome

TB

Tuberculosis

Yvonne T. Maddox, Ph.D.

Deputy Director
National Institute of Child Health and Human Development
National Institutes of Health

Stephen Strauss, M.D.

Director
National Center for Complementary and Alternative Medicine
National Institutes of Health