February 7, 2006 Meeting Minutes

February 7, 2006 Meeting Minutes

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
Sixty-second Meeting

Table of Contents

    1. Call to Order, Welcome
    2. The Disease Control Priorities Project: An Update
    3. NIAAA International Research Activities
    4. Minutes of Previous Meeting
    5. Review of Confidentiality and Conflict of Interest
    6. Dates of Future Board Meetings
    7. Report of the Director
    8. Review of Applications
    9. Adjournment

The John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) convened the sixty-second meeting of its Advisory Board on Tuesday, February 7, 2006, at 8:40 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:40 a.m. to 12:25 p.m., followed by the closed session, from 1:00 p.m. to adjournment at 2:30 p.m., as provided in Sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code, and Section 10 (d) of Public Law 92-463, for the review, discussion, and evaluation of grant applications and related information. [1] Dr. Sharon Hrynkow, Chair, Fogarty International Center Advisory Board, and Acting Director, FIC, presided. The Board roster is appended as Attachment 1.

Board Members Present:

Dr. Elizabeth Barrett-Connor
Dr. Patricia M. Danzon
Dr. Douglas Heimburger
Dr. Arthur Kleinman
Dr. Sharon L. Ramey
Dr. Lee W. Riley
Dr. William A. Vega
Dr. May L. Wykle
Dr. Ting-Kai Li, Ex officio

Board Members Absent:

Dr. Wafaie Fawzi
Dr. Robert R. Redfield

Federal Employees Present:

Mr. Kevin Bialy, FIC/NIH
Dr. Joel Breman, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Mr. Bruce Butrum, FIC/NIH
Dr. Faye Calhoun, NIAAA/NIH
Ms. Tina Chung, FIC/NIH
Dr. Jean Flagg-Newton, FIC/NIH
Dr. Henry Francis, FIC/NIH
Dr. Dan Gerendasy, CSR/NIH
Dr. James Herrington, NCI/NIH
Dr. Karen Hofman, FIC/NIH
Dr. Sharon Hrynkow, FIC/NIH
Mr. Andrew Jones, FIC/NIH
Dr. Richard M. Krause, FIC/NIH
Mr. John Makulowich, FIC/NIH
Dr. Mark Miller, FIC/NIH
Mr. Richard Miller, FIC/NIH
Ms. Sherri Park, NICHD/NIH
Dr. Aron Primack, FIC/NIH
Dr. Joshua Rosenthal, FIC/NIH
Dr. Christopher Schonwalder, FIC/NIH
Mr. Randolph Williams, FIC/NIH

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OPEN SESSION

I. CALL TO ORDER, WELCOME

Dr. Sharon Hrynkow called the meeting to order and welcomed the Board members and attendees. She extended a special welcome to Dr. Ting-Kai Li, Director, National Institute on Alcohol Abuse and Alcoholism (NIAAA), NIH, and Dr. Fayee Calhoun, Deputy Director, NIAAA. Dr. Li is a new ex officio member of the Board. He gave a presentation on NIAAA international research activities later during the meeting (see section III below).

II. THE DISEASE CONTROL PRIORITIES PROJECT: AN UPDATE

Dr. Sharon H. Hrynkow, Acting Director, FIC
Dr. Joel G. Breman, Senior Scientific Advisor, Division of International Epidemiology and Population Studies (EPS), FIC

Drs. Hrynkow and Breman presented an update of the Disease Control Priorities Project (DCPP). Dr. Hrynkow described the objectives, history, and leadership of the DCPP; and Dr. Breman discussed the key findings and current status. A similar presentation was recently given at the monthly meeting of NIH institute and center (IC) directors.

Objectives, History, and Leadership

Dr. Hrynkow described DCPP as an alliance of four organizations [the FIC, World Bank, World Health Organization (WHO), and Bill & Melinda Gates Foundation] that is supporting the review, development, and dissemination of information on improving health in developing countries. The aim is to decrease illness, disability, death, and economic burden by pursuing two objectives: (i) develop a scientific evidence base to inform decision-making (i.e., estimate the cost-effectiveness of interventions, define disease burdens, and summarize experience with implementation) and (ii) communicate major findings (i.e., suggest “best buys” and “worst buys” in interventions, disseminate the results widely, and stimulate priority setting and program implementation nationally).

The first edition of Disease Control Priorities in Developing Countries, largely a World Bank effort tied to the Bank’s 1993 World Development ReportM, was published in 1993. This was the first time the Bank considered health as a topic in economic development. In 2001, FIC conceptualized DCPP, a 4-year project that reflects a convergence of epidemiology and economics, and mobilized its partners. The Bill & Melinda Gates Foundation awarded the first of two grants to FIC to support the effort in January 2002; and, in April 2002, the work began, with consultations and selection of authors to contribute to a Working Paper Series. Dr. Dean T. Jamison, Fellow, Division of Advanced Studies and Policy Analysis (DASPA), FIC, is senior editor for the DCPP. Dr. Breman and Dr. Anthony R. Measham, the World Bank’s former Health, Nutrition, and Population Advisor at the Resident Mission, New Delhi, India, are co-managing editors.

FIC has served as secretariat for the project and has provided space and staff support. FIC staff has been critical to the management of DCPP; and several staff members have coordinated and authored chapters for the final publications.

Key Findings

Focusing on the epidemiology and burden of disease, Dr. Breman summarized data on the following topics.

Burden of Disease

DCPP relies on data collected by the World Bank and WHO and on two metrics for burden of disease: (i) death and (ii) disability-adjusted life years (DALYs). The data show that cardiovascular disease was the leading cause of death in both developed and developing regions in 2001. For developed regions, cancer was the second leading cause of death, followed by pulmonary disease; for developing regions, infections were the second leading cause of death. In developed or developing regions, the top 10 conditions accounted for more than 50 percent of all deaths worldwide and for more than 40 percent of all DALYs worldwide.

The three leading causes of DALYs lost globally in 2000 were perinatal conditions, lower respiratory infections, and HIV/AIDS. These were followed by unipolar depressive disorders, diarrheal diseases, cardiovascular disease [i.e., ischemic heart disease (IHD)], cerebrovascular disease, malaria, road traffic accidents, and tuberculosis (TB).

The overall burden of disease in low- and middle-income countries (in 2001) was largely attributable to three selected causes: infections (i.e., HIV/AIDS, malaria, TB), non-communicable diseases (i.e., malignant neoplasms, IHD, cerebrovascular disease), and injuries (i.e., road traffic accidents, suicide). These selected causes accounted for almost 50 percent of all deaths and almost 30 percent of all DALYs.

Cost Effectiveness

The DCPP established an incremental cost-effectiveness ratio for 185 personal interventions and 93 population-based interventions; and its analyses are based on broad ranges of available data and on qualitative data accumulated by DCPP teams and authors. Cost-effectiveness ratios were established for different interventions against malaria and HIV/AIDS in Sub-Saharan Africa. The data show, for example, that intermittent preventive treatment of malaria during pregnancy with sulfadoxine pyrimethamine (to prevent low birthweight in infants) and insecticide residual spraying are very cost-effective, but are less cost-effective than insecticide-treated bed nets or intermittent preventive treatment during pregnancy using chloroquine and other drugs. For HIV/AIDS, many interventions are far more cost-effective than antiretroviral treatment (ART) (e.g., prevention of mother-to-child transmission, prevention and treatment of co-infection with TB, assuring safety of blood and needles, promotion and distribution of condoms, diagnosis and treatment of sexually transmitted infections, voluntary counseling and testing, and peer programs).

Cost of Health

A question to consider is “how much health will a million dollars buy?” In the prevention and treatment of non-communicable diseases, the two interventions that are most beneficial (in terms of DALYs averted) and least costly are taxation of tobacco products and treatment of heart attacks with inexpensive drugs. In contrast, coronary artery bypass surgery and treatment with more expensive drugs are comparatively very costly per DALYs averted.

Best and Worst Buys

“Best Buys.” Selected “best buys” (i.e., neglected, low-cost opportunities) for reducing the burden of disease in terms of DALYs were highlighted in two regions: Sub-Saharan Africa and South East Asia. Childhood immunization is the most cost-effective of all interventions. Other best interventions include speed bumps, roundabouts, and increased penalties (for traffic accidents); training of ambulance personnel, lay responders, and paramedics (for surgical services and emergencies); substitution of trans-fatty acids with polyunsaturated fatty acids (for primary prevention of cardiovascular disease); and coverage for primary health care, quality general obstetrical care, and neonatal packages of care (for maternal and neonatal care). Maternal and neonatal care is exceedingly important because more than 75 percent of deaths in children under age 5 in low- and middle-income countries occur within the first year of life, with more than 50 percent being stillbirths and neonatal deaths.

“Worst Buys.” Examples of higher-cost (and therefore cost-ineffective) interventions in Sub-Saharan Africa and South East Asia are oral rehydration therapy (for diarrheal diseases); home care or ART with low adherence (for HIV/AIDS); anti-TB drugs (for TB not manifested in patients without HIV); and streptokinase or tissue plasminogen activators (for cardiovascular disease).

Main Messages

The DCPP has yielded dozens of “messages” about reducing the burden of illness, disability, death, and costs of disease. For example: (1) Life expectancy in low- and middle-income countries is increasing dramatically (rising by 5 years over the past decade), whereas health inequalities across countries are decreasing. (2) Four critical challenges facing developing countries and the world are the high levels and rapid increase in non-communicable conditions, the unchecked HIV/AIDS pandemic, the possibility of a successor to the 1918 influenza pandemic, and preventable death and disability from common diseases and conditions (malaria, TB, diarrhea, pneumonia, micronutrient malnutrition, childbirth). (3) There are some very good “buys” in interventions, some of which are familiar (e.g., micronutrient fortification), whereas others are less well known (e.g., secondary prevention of vascular disease). (4) With regard to health services, increased provision of surgical facilities in district hospitals is a highly attractive intervention, and increased public-sector financing is needed. (5) Generation and diffusion of new knowledge and products have underpinned enormous improvements in health in the 20th century, and continued progress will continue to depend on new knowledge. (6) Improved health is contributing significantly to economic welfare (i.e., 10–15 percent of economic growth in developing countries results from improvements in population health).

Current Status

The three DCPP publications will be launched in Beijing, China, on April 3–6, 2006, at a meeting organized by the DCPP, U.S. Institute of Medicine, Chinese Academy of Engineering, Chinese Academy of Sciences, and Inter-Academies Medical Panel. The three publications are: Disease Control Priorities in Developing Countries, 2nd edition, and Global Burden of Disease and Risk Factors (Oxford University Press) and Priorities in Health (World Bank). These books also will be available electronically on the National Library of Medicine (NLM) Web site.

As follow up to the publications, the Bill & Melinda Gates Foundation is funding a collaborative 18-month dissemination effort by the Population Reference Bureau, FIC, and the World Bank. The aim is to support implementation activities and encourage countries to utilize the published findings and define their own priorities for health. Dr. Breman anticipated that the publications will enhance debate on the contribution of health to economic welfare and stimulate more investments in health.

Additional information about DCPP is on the FIC Web site (www.fic.nih.gov/dcpp). In addition, the DCPP anticipates having its own Web site by April 2006 (see www.dcp2.org).

Dr. Breman highlighted the importance of incorporating research into the DCPP, noting that the DCPP captures interventions studied in both the laboratory and the field and focuses on dissemination of proven interventions. The 1993 publication on disease control priorities did not address research. Dr. Breman also noted that all research is global; that health is a global public good; and that research priorities for the future must include utilization of the fast-growing field of information technology to disseminate knowledge, as well as development of a critical mass of leaders in science and public health. In the DCPP publications, five chapters directly address research issues, every chapter includes a research agenda, and a separate research paper will summarize the research agendas.

Discussion

DCPP Design

The Board raised various concerns about the metrics used to weigh the cost-effectiveness of interventions. A member spoke concerning the difficulty of separating out the contributions of multiple interventions used simultaneously (e.g., for HIV/AIDS and TB). The Board particularly noted the limitations of DALYs which, as a measure applicable to individuals, do not account for the broader socioeconomic costs and benefits of interventions or the burden of diseases (e.g., Alzheimer’s disease, depression) for families. Members concluded that, for these reasons, estimates of DALYs must be viewed as an undercount of the costs and benefits of disease.

DCPP Data

The Board noted that although health inequalities may be decreasing across countries, they are, in fact, increasing across populations in countries that are undergoing rapid social change (e.g., China). Members raised questions about the validity and reliability of the data on burden of disease and all causes of death. They noted, for example, that data on the often large subpopulations that live in urban slums are sparse and that underlying diseases or co-morbid conditions may not be considered. Commenting on the reported dramatic increase in life expectancy in low- and middle-income countries, a member noted that life expectancy in Sub-Saharan Africa has decreased dramatically, which would suggest that the reported data may be too “rosy.” Another member noted that, in general, much of the epidemiology data on Africa is extrapolated from studies in Nigeria, and a member cautioned that most of the data on cost-effectiveness has been generalized from small field epidemiology studies to obtain regional and national averages.

The Board particularly focused on mental disorders and diabetes. One member noted that capturing the costs of a mental disorder such as depression is difficult because depression both causes significant morbidity and contributes to suicide as well. The relationship between depression and suicide occurs worldwide, but has not been documented statistically. Another member remarked that diabetes, which is listed as the 8th leading cause of death in developed regions, has become a worldwide epidemic and underpins cardiovascular disease in many parts of the world such as Asia and India.

Proposed Follow-up Action

The Board asked whether any centralized effort is planned to monitor the effects of DCPP recommendations on low- and middle-income countries’ decision-making on disease interventions and treatments. FIC staff noted that centralized monitoring is included in the DCPP recommendations, but no funds have been allocated for this effort thus far.

FIC Response

Dr. Breman agreed with the Board's concerns expressed during the discussion. He said that DCPP authors debated many of the same issues and address these issues in various chapters of the publication. He particularly noted the tension between epidemiologists and health economists arising from their different foci and perspectives. He also noted that the concerns raised by the Board are scientific opportunities that need to be addressed through research, particularly longitudinal, population-based field studies.

Dr. Hrynkow said that FIC will send all three DCPP publications to the Board members when they become available. In addition, FIC will plan to have a follow-up discussion of the DCPP at the Board’s September 2006 meeting.

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III. NIAAA INTERNATIONAL RESEARCH ACTIVITIES

Dr. Ting-Kai Li, Director, NIAAA

Dr. Li told the Board members that he was honored to be invited to join them and then began his presentation. Dr. Li summarized the history of NIAAA, defined alcohol use disorders, shared selected data and findings on alcohol use in the United States and other countries, and highlighted ongoing NIAAA international efforts. The 2001 data from the DCPP list alcohol use as the 7th risk factor contributing to cardiovascular disease mortality in low- and middle-income countries, just after smoking. Dr. Li noted that alcohol is human’s most primitive intoxicant. Studies of archeological sites document the use of barley beer in Egypt in 4200 BC and the production of prehistoric fermented beverages in China in 7000 BC.

History of NIAAA

NIAAA was legislatively created in 1970; its mission was primarily focused on service. From 1973 to 1992, NIAAA was part of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). The Institute became entirely a research institute in 1981 with the transfer of its service components to other parts of the ADAMHA organization; in 1992, it became an NIH institute. Dr. Li noted that the current mission of NIAAA is to provide leadership in the national effort to reduce alcohol-related problems—by conducting and support research; coordinating and collaborating with other research institutes and Federal programs; collaborating with international, national, state, and local organizations; and translating and disseminating research findings.

Definitions

Alcohol abuse and alcoholism are collectively termed Alcohol Use Disorders (AUDs); however, they are separate diagnostic categories in the 4th edition of the Diagnostic and Statistical Manual (DSM) of the American Psychiatric Association (DSM-IV) and are defined differently. “Alcohol abuse” is defined as a pattern of high-risk drinking that results in recurring personal, interpersonal, and societal problems (e.g., driving under the influence of alcohol), whereas “alcoholism or alcohol dependence” is defined as loss of control, preoccupation with drinking, compulsive drinking, and physical dependence (i.e., addiction). Dr. Li noted that a large body of genetic and epidemiological research shows that about 50 percent of the risk for developing alcohol dependence is genetic, complicated by other biological and environmental risk factors.

Selected Data and Findings

The Burden of AUDs

Currently, AUDs are largely a problem of well-developed countries. The extent of AUDs is well documented in the United States. Data show that 18 million Americans (i.e., 8.5 percent of the population 18 years and older) suffer from alcohol abuse, alcohol dependence, or both; alcohol problems cost U.S. society an estimated $185 billion annually; and alcohol was the third leading cause of death in 2000 (with an estimated 85,000 deaths annually). Dr. Li noted that the global prevalence of AUDs is much lower (estimated at 1.7 percent in 2003) than in the United States and accounts for 1.4 percent of the total burden of disease worldwide. However, the difficulties in collecting and reporting alcohol-related data across countries may lead to underestimates of these global data.

In the United States, AUDs account for approximately 50 percent of all motor vehicle accidents, which are the 6th leading cause of death in the United States. WHO data show that the burden of disease (i.e., percent of DALYs) attributable to alcohol is greatest in Central and South America and in Ukraine and Eastern Europe (5–15.9 percent); the next greatest burden is in Canada and the United States (4–7.9 percent). Dr. Li noted that WHO data, which differ from data reported by the DCPP, also show that alcohol is the 3rd leading risk factor for burden of disease in developed countries, after tobacco and blood pressure.

Alcohol Consumption

A 2001–02 epidemiological survey of approximately 45,000 individuals in the United States indicates that 65 percent of the U.S. population are drinkers (i.e., report drinking at least one drink in the past 12 months) and that males consume three times more alcohol than do females. Dr. Li highlighted a very important finding with reference to mortality and cost—that is, 73 percent of the alcohol is consumed by 10 percent of the population.

From 1960 to 2000, per capita consumption of alcohol among adults, ages 15 years and older, steadily increased in developing countries to approximately 1.5 liters per year; in China and countries of the former Soviet Union, which are undergoing major economic and demographic changes, the increases were much greater (to approximately 4.5 liters per year). In contrast, adult per capita consumption in developed countries declined to approximately 5 liters per year, except for Japan where per capita consumption rose to almost 8 liters per year before rapidly decreasing in recent years.

Patterns of Drinking

Health and personal and social problems related to alcohol use arise from certain patterns centered around quantity, frequency, and duration—for example: “too much too fast” and “too much too often.” Dr. Li noted that frequency of drinking is usually overlooked in diagnosing alcohol abuse or dependence; and, yet, it is an important measure for determining risk for complications from drinking (i.e., alcohol abuse and alcohol dependence). For example, in the United States, the limits determining hazardous versus non-hazardous drinking are 14 drinks for men and 7 for women in a typical week and 4 drinks for men and 3 for women in a day. An individual who exceeds both the weekly and daily limits (quality, frequency, and duration) once a week or more is 219.4 times more likely to develop alcohol dependence than is an individual who does not exceed these limits.

Recent population data on the prevalence of alcohol abuse and alcohol dependence in the United States confirm that these are a disease of youth; the highest prevalence of diagnosable alcohol dependence occurs between the ages of 18 and 24, with sharp declines in the onset of alcohol dependence symptoms thereafter. Dr. Li emphasized that the view of alcoholism as a young person’s illness is one that contrasts with the medical school focus on alcoholism as a chronic, recurring disorder occurring primarily in middle to late life. Data on the prevalence of alcohol abuse and alcohol dependence, by sex and gender, vary among countries. For example, in China, alcohol abuse among males is much lower than in the United States, while alcohol dependence among males is higher. Both alcohol use and alcohol dependence are very low among females in China. Dr. Li suggested that important insights could be gained by monitoring changes in these data as China develops.

Binge drinking, defined as five drinks for males and four drinks for females within 2 hours, is the most dangerous of all drinking patterns, and it is a very common pattern among young people. For the period 1975 to 2002, the trend in the United States regarding the percent of students in grades 8, 10, and 12 who reported binge drinking has seen modest declines since the late 1980s when the drinking age was raised from18 to 21 in all states. Still, the drinking patterns during this time period for monthly, yearly, and binge drinking among U.S. high school seniors have been very at high, albeit stable, rates. Dr. Li observed that although binge drinking is not uncommon among adults, particularly young adults, underage youth are more likely to engage in this hazardous drinking pattern than are adults, who drink more frequently than underage youth but have fewer drinks per drinking occasion.

Age of Onset of Alcohol Dependence and Co-occurring Conditions. Dr. Li highlighted two main risk factors for alcohol dependence: the age a person starts drinking and co-morbid conditions. Longitudinal studies indicate that the earlier an individual starts to drink (e.g., at ages 13–14), the greater the likelihood the individual will become alcohol dependent. This likelihood is even greater for individuals who have a positive family history of alcohol dependence, compared with those who do not. In addition, the onset of AUDs (and drug disorders) from age 10 onward coincides with the age of onset for brain disorders such as obsessive compulsive disorders, eating disorders, bipolar or panic disorders, and social phobias. Dr. Li noted that many of these conditions are co-morbid with AUDs. There is a critical window of opportunity for preventing the onset of alcohol problems and co-occurring conditions in adolescence; and understanding the developmental trajectory of these disorders will provide the basis for evidence-based approaches for effective prevention and intervention.

Alcohol Consumption and Youth—A Global Health Problem. Dr. Li stated that alcohol consumption by youth is a global problem. For example, in Europe, contrary to popular opinion, family drinking, which begins at an early age, does not appear to protect European youth against binge drinking, which is much more frequent in most European countries than it is in the United States for both males and females. Dr. Li further noted that, in Japan, where there are 3 million problem drinkers, alcohol abuse and dependence are particular problems; WHO data on alcohol show that 60 percent of high school juniors and 70 percent of seniors report having drinking experiences, which include drinking one or more times a week (reported by 5 percent of juniors and 10 percent of seniors); and individuals ages 20–34 have nearly twice the rate of alcohol dependence as older individuals.

NIAAA International Collaborations

Dr. Li reported that NIAAA has signed letters of intent for international collaborations with research organizations in China (Beijing, Shanghai), Japan, and Taiwan. The collaborations involve basic research (e.g., pharmacogenetics, pharmacogenomics, psychiatric genetics), clinical studies and trials, prevention and treatment strategies, epidemiology studies (e.g., gene–environment interactions), research training, and workshops. NIAAA is also supporting collaborative studies of fetal alcohol syndrome in Russia and South Africa and staff members have met with counterparts at L’Institut National de la Santé et de la Recherche Médicale (INSERM), France, to discuss mutual interests in the genetics of alcohol abuse and dependence.

Dr. Li concluded that AUDs and their consequences are health problems of sizable dimensions globally and that conditions which are highly co-morbid with AUDs (e.g., nicotine dependence, antisocial personality, and mood and anxiety disorders) are significant health burdens. He noted that there are many opportunities for international collaboration, and he focused on two specific areas of research opportunity—underage and binge drinking, and alcohol and co-occurring disorders.

Discussion

The Board asked a number of questions that touched on critical areas such as the identification of factors, genetic and environmental, that lead to lifetime alcohol dependence; genetic variances protective against alcohol dependence; population variants in alcohol dehydrogenase and aldehyde dehydrogenase, two key enzymes related to alcohol use and abuse; and gender effects on alcohol use. Additional research opportunities which were mentioned include studies of the relationship of alcohol dependence to lifetime expectancy (e.g., in Japan) and comorbid effects of life changes (e.g., loss of spouse or children, inactive retirement) on alcohol dependence.

Responding to the Board’s suggestion that the cultural dimensions of drinking need to be better understood, Dr. Li reported his observation that cultural barriers (e.g., admitting to drinking) may impede studies of alcohol use. He noted, however, that policy changes such as the establishment of legal drinking age and/or laws against selling alcohol to minors as well as preventive interventions in primary and secondary schools have been effective in reducing alcohol use among youth.

Dr. Li concluded by saying that alcohol use, alcohol use disorders (including dependence), and recovery are complex processes and that the factors that affect an individual’s decisions regarding use of alcohol are unknown. Further, alcohol dependence is heterogeneous within populations and includes many different subtypes. Whereas most studies of alcohol abuse and dependence have been clinical and individually focused, longitudinal and population-based epidemiology studies linked to preventive interventions are needed.

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IV. MINUTES OF PREVIOUS MEETING

The minutes of the Advisory Board meeting of September 13, 2005, were considered and approved unanimously.

V. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST

The rules and regulations pertaining to conflict of interest were maintained.

VI. DATES OF FUTURE BOARD MEETINGS

The following meeting dates are confirmed:

Tuesday, May 23, 2006
Tuesday, September 12, 2006

Tuesday, February 6, 2007
Tuesday, May 22, 2007
Tuesday, September 11, 2007.

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

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VII. REPORT OF THE DIRECTOR

Dr. Sharon H. Hrynkow, Acting Director, FIC

Dr. Hrynkow reported on personnel changes, activities across NIH, and FIC program-related activities. Mr. Richard Miller, Executive Officer, FIC, reported on the Fiscal Year (FY) 2006 and FY 2007 budgets and 20-year budget trends at FIC. FIC division directors reported on their division activities. The roster of the Board members is appended to these minutes as Attachment 1 and the written Report of the Director is appended as Attachment 2.

Personnel Changes

NIH

Dr. Hrynkow reported that the National Institute of Allergy and Infectious Diseases (NIAID) restructured its Office of the Director with the appointment of five senior managers. Among these, Dr. Hugh Auchincloss, Jr., has been named Principal Deputy Director; Dr. Clifford Lane has been named NIAID Deputy Director for Clinical Research and Special Projects; and Dr. John J. McGowan has been appointed to the new position of NIAID Deputy Director for Science Management.

FIC

Dr. Hrynkow said that Ms. Natalie Tomitch, Program Officer for Russia, FIC, has joined the NIH Office of AIDS Research (OAR) where she is responsible for the OAR international portfolio. Ms. Rita Singer, Lawton Chiles International House Manager, retired from Federal service at the end of December 2005.

FIC Budget

FY 2006

Mr. Miller noted that, on December 30, 2005, the President signed the FY 2006 Labor and Health and Human Services appropriations bill, which includes NIH. On the same day, the President signed the Defense appropriation bill, which included a provision to reduce all non-emergency discretionary funds by 1 percent. The net effect of this provision for NIH was an FY 2006 budget of approximately $28.5 billion, or about 2 percent less than the NIH budget for FY 2005.

The FIC budget for FY 2006 is $66.3 million, or about 0.4 percent less than in FY 2005 ($66.6 million). Mr. Miller remarked that FY 2006 is a very tight budget year and that FIC has to make difficult decisions as it reviews each program and, particularly, new and competing grant applications. He noted that NIH policy requires that the funding of each non-competing research project grant be reduced by 2.35 percent and that, in addition, FIC may decrease its funding of other research grants (i.e., research training) by an average of 5 percent in order to “free up” monies that could be used to enhance other existing programs.

For FY 2006, FIC is continuing and emphasizing the following programs: the Framework Programs for Global Health and the Fogarty International Collaborative Trauma and Injury Research Training Program, both of which were initiated in FY 2005 and will be recompeted in FY 2006; the Global Health Research Initiative Program for New Foreign Investigators (GRIP); and leadership training and Internet mentoring for women scientists. Mr. Miller said that FIC is being aggressive in encouraging its co-funding partners (other ICs, agencies) to continue their support of FIC programs.

FY 2007

The President’s Budget for FY 2007, which was released on February 6, requests essentially the same level of funding for NIH as in FY 2006. Mr. Miller noted that the NIH Director has proposed a number of new initiatives, which include a large increase of approximately 6 percent for biodefense research. For FIC, the budget request is for approximately $66.68 million, or an increase of approximately 0.5 percent, mostly for AIDS research and training. Mr. Miller noted that the average budget reduction across ICs is approximately 0.6 percent and that the only increases, which are slight, are for NIAID and FIC.

Programs that FIC proposes to highlight in FY 2007 include AIDS research and training; planning grants for the International Clinical, Operational, and Health Services Research Training Program in Malaria (ICOHRTA-Malaria); Ecology of Infectious Diseases (EID) program; and health research on indigenous peoples issues. In addition, FIC will contribute, as will all other ICs, to expansion of NIH Roadmap initiatives and two new NIH programs—the Pathway to Independence Program, for new investigators, and the NIH Genes and Environment Initiative. Mr. Miller anticipated that Senate and House hearings on the FY 2007 budget will occur in mid-March, with subsequent action taken throughout the summer of 2006.

Dr. Hrynkow commented that FIC grantees are successful in applying for and obtaining awards under NIH Roadmap initiatives, and she noted the need to be vigilant about reminding grantees of these NIH opportunities. Mr. Miller commented that an FIC grantee received an NIH Director’s Pioneer Award in FY 2005.

20-Year Trends

Mr. Miller displayed the FIC budget trends from FY 1988 to FY 2007, which include the doubling of the NIH (and FIC) budget beginning in FY 1999 and the leveling of the budget beginning in FY 2004. He noted that the FIC budget is augmented significantly by co-funding from other ICs and agencies, which amounted, for example, to approximately $23 million in FY 2005.

Activities across NIH

Office of Portfolio Analysis and Strategic Initiatives (OPASI)

Dr. Hrynkow reported that Dr. Zerhouni created OPASI within the Office of the Director, NIH, and has launched a national search for a director for the new office. The purpose of OPASI, which is a next step in the evolution of the NIH Roadmap, is to identify research gaps and to functionally integrate the ICs around key topics. The decision-making process to identify research gaps will involve NIH advisory councils and boards, IC directors, and the extramural community. IC commitments to the NIH Roadmap will be used to fund 5- to 10-year research projects in selected areas. Dr. Hrynkow noted that a Board member will be asked to represent FIC on an NIH “council of councils.”

Global Health at NIH

Dr. Hrynkow said that FIC continues to be vigilant about keeping global health on the NIH screen. One approach is to organize and support global health lectures. On October 7, 2005, FIC and NICHD were two co-sponsors for the annual Lawton Chiles Lecture on Maternal and Child Health in the Americas. The guest speaker, Dr. Jose Santos of Mexico, spoke about child health priorities.

On November 15, FIC and the National Institute of Dental and Craniofacial Research cosponsored the annual David E. Barmes Global Health Lecture at NIH. This year’s lecture was given by Dr. Rita R. Colwell, former Director, National Science Foundation, and former Board member. She addressed the merging of physical, life, and social sciences in cholera research and interventions.

FIC Activities

Upcoming Events

Dr. Hrynkow invited Board members to attend two upcoming events. On February 14, 2006, FIC will host “Millions Saved,” a presentation based on a publication that documents case studies of effective low-cost interventions applied on a large scale. The presenter will be Dr. Ruth Levine, Director of Programs and Senior Fellow, Center for Global Development, and author of the publication, which is entitled Millions Saved: Proven Successes in Global Health. The event will take place at the Lawton Chiles International House. Dr. Hrynkow said that FIC will send copies of the publication to the Board.

On March 8, at the Lawton Chiles International House, FIC will celebrate International Women’s Day. For the third consecutive year, foreign women scientists working in the NIH intramural laboratories will describe their research and share their perspectives on career paths.

Global Health Research and Training

Consultations/Symposia: Dr. Hrynkow noted that FIC convenes consultations to explore critical issues and inform program development at FIC. On November 7–9, in Rockville, Maryland, FIC teamed with the National Institute on Drug Abuse to conduct an international consultation on Inhalant Abuse among Children and Adolescents: Building an International Research Agenda. Dr. Karen Hofman, Director, DASPA, reported that FIC and the National Institute on Mental Health conducted five panel discussions/workshops at the XXIII International Association for Suicide Prevention Congress, held in Durban, South Africa, on September 8–18, 2005. Dr. Hofman noted that the principal panel involved several FIC grantees and focused on the translation of basic science findings to prevention of suicide. This was well received. In addition, FIC convened discussions on NIH international grant opportunities and on Arctic health issues.

Network Meetings: Dr. Hrynkow noted that FIC continues to hold network meetings for FIC grantees in various FIC programs. These network meetings are a hallmark of FIC programs. Dr. Joshua Rosenthal, Deputy Director, Division of International Training and Research (DITR), reported on the 4th Network Meeting of the Ecology of Infectious Diseases Program. The meeting was held in conjunction with the Annual Meeting of the Society for Tropical Medicine and Hygiene (ASTMH), held in Washington D.C. at the Hilton Hotel, December 15–16, 2005. Dr. Rosenthal noted that more than 100 U.S. and foreign scientists and graduate students attended the network meeting, which included a symposium on FIC-sponsored research on the ecology of infectious diseases held during the ASTMH general meeting. The network meeting included grantees from approximately 35 projects and featured the work of graduate students. Dr. Rosenthal remarked that ecology of infectious diseases is a growing and exciting research field and that a number of new faculty positions are open.

Dr. Hrynkow commented that FIC highlighted the EID program in its congressional justification for the FY 2007 President’s Budget, in part because of the emerging avian flu problem and to emphasize the need to develop knowledge, beyond surveillance, to predict and prevent emergence of diseases.

In December 2005, FIC also convened a network meeting of leaders in the FIC International Collaborative Genetics Research Training Program.

Leadership Training and Mentoring for Women Scientists: Dr. Hrynkow provided a historical perspective and update on this FIC activity. In October 2003, FIC partnered with the Office of Research on Women’s Health and the National Institute of Environmental Health Sciences to host a colloquium on career paths for women in science in the developing world. Approximately 60 individuals from around the world attended and shared their experiences and discussed obstacles for women in science.

Several recommendations emerged from the colloquium, and FIC has acted on three of them—to provide leadership training to women in science, use the Internet for mentoring of women in science, and gather data on the status of women scientists in universities. In June 2005, FIC conducted a pilot leadership training session for women who had received the FIC GRIP award, and the enthusiastic response to this pilot led to development of a broader FIC program to train women from developing countries who are involved in any FIC training programs. In collaboration with the United Nations Educational, Scientific, and Cultural Organization (UNESCO) Regional Chair for Women, Science, and Technology in Latin America, FIC is developing a curriculum for mentoring junior women scientists, and the first-time-ever Internet mentoring session for women in Latin America will take place shortly, utilizing Elluminate software technology. FIC also is collaborating with UNESCO to develop and conduct a survey of women scientists in Latin America.

Dr. Hrynkow noted that momentum is building on the issue of women in science. She thanked FIC staff, and particularly Drs. Hofman and Ana Chepelinksy, Program Director for Latin America, for forging forward on this issue.

Diplomatic Outreach and International Relations

Embassy Science Fellows Program (ESFP): Dr. Hrynkow reported that FIC initiated NIH participation in this new Department of State program. The ESFP places U.S. Government (USG) scientists at overseas embassy posts for periods of 1–3 months to provide expertise, advice, and assistance on issues relating to the environment, science and technology, and health. The program also provides a valuable mechanism through which experts from USG technical agencies can assist posts on country-specific scientific issues. This year, NIH will send an expert to Laos, Portugal, and possibly Indonesia. The Department of State has Environment, Science, and Technology (EST) Officers in the larger embassies abroad; smaller embassies do not have such dedicated science officers.

International Visits: Dr. Hrynkow noted that an FIC goal is to work as closely as possible with the NIH Director on the international agenda. In December 2005, she joined Dr. Zerhouni for a series of site visits in Shanghai, China, at institutions of the Chinese Academy of Sciences (CAS). In subsequent meetings in Beijing, China, the NIH Director signed an Amendment to the NIH–CAS Agreement to expand cooperation in the behavioral sciences, research training, and life sciences. Dr. Hrynkow noted that the largest number of foreign scientists in the NIH intramural program is from China.

In January 2006, Dr. Hrynkow and Ms. Judy Levin, Program Officer for the Middle East and North Africa, Division of International Relations (DIR), FIC, were part of an NIH delegation led by Dr. Zerhouni that met with senior government officials and biomedical researchers in Algeria, Tunisia, and Morocco to discuss potential areas of mutual cooperation. Dr. Hrynkow commented that NIH has little activity in North Africa and that the three countries recently graduated from being recipients of significant funds from the U.S. Agency for International Development. Planned activities following the January meetings include an NICHD-supported regional conference on newborn screening and a regional workshop on HIV/AIDS.

Coordination of NIH International Efforts: Dr. Hrynkow noted that FIC continues to serve as the “glue” for NIH international functions and activities. Every 2 months FIC convenes meetings of the NIH International Representatives across the ICs to address common issues and concerns. A representative of the Centers for Disease Control and Prevention also attends these meetings. At the most recent meeting, in January 2006, Dr. Jamison presented an update on DCPP.

Staff Publications

Dr. Hrynkow referred the Board to the recent, peer-reviewed staff publications listed in the written Director’s Report. She noted, in addition, that The Lancet is devoting an upcoming issue to stigma and global health which will contain the papers presented at the FIC-sponsored international conference on Stigma and Global Health: Developing a Research Agenda, held in September 2001 at NIH [see The Lancet vol. 367, no. 9509, February 11, 2006]. Dr. Hrynkow thanked Dr. Arthur Kleinman for helping FIC explore this issue, helping to organize the 2001 conference, and guiding the publication effort.

Division Activities

DITR: Dr. Kenneth Bridbord, Director, DITR, reported that DITR staff have been exceptionally busy with the recompetition of awards in many FIC programs. He noted that FIC will convene a network meeting on TB for grantees across the FIC programs, in San Diego, California, February 8–10, 2006. The meeting is being linked with the National Heart, Lung, and Blood Institute-funded National Tuberculosis Curriculum Consortium; and Dr. Lee W. Riley will represent the Board at the meeting. Dr. Bridbord noted, in addition, that DITR staff are working with other division staff at FIC to identify potential FIC contributions to the Federal Avian Flu Initiative.

DIR: Dr. James Herrington, Director, DIR, presented a brief update of staff activities. DIR staff are contributing veterinarian expertise to international efforts (e.g., in zoonoses and avian flu, the International Polar Year, Arctic concerns), planning and organizing international visits and meetings, interfacing with multilateral organizations, guiding FIC efforts in women’s health, and coordinating information on NIH activities under the U.S.–Russia Science and Technology Agreement.

Dr. Herrington noted that DIR staff, working with all ICs, recently developed the NIH response to policy documents for the upcoming World Health Assembly. DIR is also leading FIC’s effort with the Japan Society for the Promotion of Science to host a symposium for Japanese scientists in the NIH intramural program, to be held in November 2006 at NIH. In addition, DIR staff will participate in the Global Health, Women and Children conference, to be held in Bangladesh February 13–17, 2006. Dr. Herrington noted that a particular interest is the need for research on the health effects of contaminated groundwater in Bangladesh, as well as other areas of the world.

DASPA: Dr. Hofman noted that DASPA activities include preparing FIC responses to requests from Congress, developing the FIC congressional justification for the President’s Budget, garnishing success stories from FIC grantees, and conveying the effectiveness of FIC programs to a range of audiences. She commented that FIC efforts (e.g., in bioethics, HIV/AIDS) have made enormous differences worldwide and are a testament to FIC involvement in the global health arena and that individuals who have participated in FIC training programs are having a large impact on policy efforts in many areas (e.g., Sub-Saharan Africa). DASPA continues to evaluate key FIC programs, including currently the AITRP.

EPS: Dr. Mark Miller, Director, EPS, reported that, within the past 2 years, EPS staff has produced approximately 60 published papers and 10 book chapters on subjects as diverse as malaria, influenza, vaccine development, ecology of infectious diseases, and economics. He noted that, 5 years ago, EPS initiated a multinational influenza seasonal mortality study, which now involves approximately 12 nations, including 6 of the 8 G-8 countries. The participants are reviewing secondary source data on vaccine effects and strategies and publishing findings on the impact of influenza vaccine on various target groups.

In partnership with the Bill & Melinda Gates Foundation, EPS staff are studying two issues—diarrhea and the ecology of organisms, and the role of zinc in health. In collaboration with other ICs, specifically NIAID and NICHD, staff are focusing on translational research in vaccine development. Dr. Miller noted that EPS often catalyzes broader NIH efforts, such as the Modeling of Infectious Diseases (MIDAS) effort at the National Institute of General Medical Sciences and the genomics of influenza project at NLM and the National Center for Biotechnology Information. For MIDAS, two EPS staff members serve on the steering committee, including one member who chairs the committee.

Discussion

Dr. Hrynkow thanked the division directors for their reports. Dr. Richard M. Krause, Senior Scientific Advisor, FIC, noted that he visited a FIC-supported HIV/AIDS training site in India where he met three Fogarty/Ellison fellows. He was greatly impressed by the efforts of that program—reaching out into the community with prevention programs, treating patients, and carrying out research—and suggested that Board members take time in their international travels to visit FIC-supported programs and grantees and to provide feedback to FIC. Dr. Hrynkow encouraged the Board members to inform FIC of their travel schedules so that staff could facilitate these visits. She thanked all FIC staff for their efforts.

VIII. REVIEW OF APPLICATIONS

Dr. Hrynkow chaired the remainder of the meeting during which the Research Awards Subcommittee reported on its activities. The FIC Advisory Board reviewed a total of 45 scored competing applications at its February 7 meeting. [2] The applications were in the following programs:

  • 11 applications for the Fogarty International Research Collaboration Award (FIRCA), out of a total of 38 applications, for $1,075,575;
  • 10 applications for the Fogarty International Collaborative Trauma and Injury Research Training Program (TRAUMA), out of a total of 13 applications, for $1,294,914;
  • 24 applications for the Brain Disorders in the Developing World: Research Across the Lifespan (BRAIN) program, out of a total of 68 applications, for $10,255,353.

The Board concurred with the initial review group recommendations for 45 out of 45 applications.

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IX. ADJOURNMENT

There being no further business, the meeting was adjourned at 2:30 p.m. on February 7, 2006.

Abbreviations Used in the Minutes

ADAMHA

Alcohol, Drug Abuse, and Mental Health Administration

AIDS

Acquired Immunodeficiency Syndrome

ART

Antiretroviral treatment

ASTMH

Annual Meeting of the Society for Tropical Medicine and Hygiene

AUDs

Alcohol Use Disorders

BRAIN

Brain Disorders in the Developing World: Research Across the Lifespan

CAS

Chinese Academy of Sciences

CSR

Center for Scientific Review

DALYs

Disability-Adjusted Life Years

DASPA

Division of Advanced Studies and Policy Analysis

DCPP

Disease Control Priorities Project

DIR

Division of International Relations

DITR

Division of International Training and Research

DSM

Diagnostic and Statistical Manual

EID

Ecology of Infectious Diseases

EPS

Division of International Epidemiology and Population Studies

ESFP

Embassy Science Fellows Program

EST

Environment, Science, and Technology

FIC

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

FIRCA

Fogarty International Research Collaboration Award

FY

Fiscal Year

GRIP

Global Health Research Initiative Program for New Foreign Investigators

HIV

Human immunodeficiency virus

IC

Institute and Center

ICOHRTA-Malaria

International Clinical, Operational, and Health Sciences Research Training Award Program for Malaria

TRAUMA

International Collaborative Trauma and Injury Research Training Program

IHD

Ischemic heart disease

INSERM

L'Institut National de la Sante et de la Recherche Medicale

MIDAS

Modeling of Infectious Diseases

NIAAA

National Institute of Alcohol Abuse and Alcoholism

NIAID

National Institute of Allergy and Infectious Disease

NICHD

National Institute of Child Health and Human Development

NIH

National Institutes of Health

OAR

Office of AIDS Research

OPASI

Office of Portfolio Analysis and Strategic Initiatives

TB

Tuberculosis

UNESCO

United Nations Educational, Scientific, and Cultural Organization

USG

U.S. Government

WHO

World Health Organization

Fogarty International Center Advisory Board Roster

(All terms end January 31)

February 2006

Sharon Hrynkow, Ph.D. (Chair)

Acting Director
Fogarty International Center

Douglas C. Heimburger, M.D., M.S. (2008)

Professor, Division of Clinical Nutrition and Dietetics
Departments of Nutrition Sciences and Medicine
University of Alabama at Birmingham
Birmingham, AL 35294-3360

Lee W. Riley, M.D. (2007)

Professor of Infectious Diseases and Epidemiology
School of Public Health
University of California Berkeley
Berkeley, CA 94720

Elizabeth Barrett-Connor, M.D. (2008)

Professor and Division Chief
Division of Epidemiology
Department of Family and Preventive Medicine
University of California, San Diego
La Jolla, CA 92093-0607

Arthur Kleinman, M.D., M.A. (2009)

Esther and Sidney Rabb Professor and Chair
Department of Anthropology
Harvard University
Cambridge, MA 02138

William A. Vega, Ph.D. (2009)

Professor Psychiatry
Robert Wood Johnson Medical School
Piscataway, NJ 08854

Patricia M. Danzon, Ph.D. (2008)

Ceilia Moh Professor
Health Care Systems Department
The Wharton School
University of Pennsylvania
Philadelphia,PA 19104-6218

Sharon L. Ramey, Ph.D. (2006)*

Susan H. Mayer Professor of Child and Family Studies
Georgetown University School of Nursing and Health Studies, and
Founding Director, Georgetown Center on Health and Education
Washington, D.C. 20057-1107

May L. Wykle, Ph.D. (2007)

Dean
Frances Payne Bolton School of Nursing
Case Western University
Cleveland, OH 44106

Wafaie Fawzi, M.D., Dr. P.H. (2007)

Associate Professor of Nutrition and Epidemiology
Department of Nutrition
Harvard School of Public Health
Boston, MA 02115

Robert R. Redfield, M.D., 2006*

Professor of Medicine
University of Maryland, Baltimore
Baltimore, MD 21201-1192

*Extended term of 180 days will end on July 31, 2006.

EX-OFFICIO Member

Ting-Kai Li, M.D. (2010)

Director
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, Bethesda, MD

EXECUTIVE SECRETARY

Jean Flagg-Newton, Ph.D.

Office of the Director
FIC International Center
National Institutes of Health
Bethesda, MD 20892

[1] Members absent themselves from the meeting when the Board discusses applications from their own institutions or when a conflict of interest might occur. The procedure applies only to individual applications discussed, not to en bloc actions.

[2] Applications that were noncompetitive, unscored, or not recommended for further consideration by initial review groups were not considered by the Board.