FY 2011 House Appropriations Testimony
Witness appearing before the
House Subcommittee on Labor-HHS-Education Appropriations
JACK E. WHITESCARVER, PH.D.
Director for AIDS Research
April 21, 2010
Mr. Chairman and Members of the Committee:
I am pleased to present the Fiscal Year (FY) 2011 President's budget request for the trans-NIH AIDS research program, which is $3,184,336,000. This amount is an increase of $98,739,000 over the FY 2010 Enacted level. It includes the total trans-NIH funding for intramural and extramural research, research management support, research centers, basic and clinical research on HIV/AIDS. The NIH AIDS budget also includes funding for research on the wide spectrum of HIV-associated malignancies, opportunistic infections, co-infections, and clinical complications.
NIH-funded AIDS research has led to: the critical discovery of antiretroviral therapies and regimens that have resulted in improved life expectancy for those with access to and who can tolerate these drugs; the development of treatments for many HIV-associated co-infections, malignancies, and clinical manifestations; and advances in HIV prevention, including groundbreaking strategies for the prevention of mother-to-child transmission. Despite these important advances, the epidemic continues to expand, and improved prevention strategies and therapeutic regimens are urgently needed.
The AIDS Pandemic
AIDS remains a global scourge that affects people in nearly every country worldwide. UNAIDS estimated that in 2008, more than 33 million people were living with HIV/AIDS; 2.7 million were newly infected; and 2 million people died of AIDS-related illnesses. More than 25 million men, women, and children worldwide have already died. The pandemic affects the future of families, communities, military preparedness, national security, political stability, economic growth, agriculture, business, health care, child development, and education in countries around the globe.
In the United States, HIV/AIDS continues to be an unrelenting public health crisis. CDC reports that over 1.1 million people are infected with the virus; approximately 56,300 new infections occur each year; and someone is infected with HIV every nine and a half minutes. The epidemic disproportionately affects racial and ethnic populations, women of color, young adults, and men who have sex with men. The number of individuals aged 50 years and older living with HIV/AIDS is increasing, due in part to antiretroviral therapy, which has made it possible for many HIV-infected persons to live longer, but also due to new infections in individuals over the age of 50. The most recent CDC data show that persons aged 50 and older accounted for: 15% of new HIV/AIDS diagnoses; 24% of persons living with HIV/AIDS (increased from 17% in 2001); 19% of all AIDS diagnoses; and 35% of all deaths of persons with AIDS. One out of every 20 individuals in the District of Columbia is estimated to be HIV-infected — a vivid example of the impact of AIDS on racial and ethnic populations in the United States.
The Trans-NIH AIDS Research Program
To address this pandemic, NIH has established the largest and most significant AIDS research program in the world, a comprehensive program of basic, clinical, translational, and behavioral research in domestic and international settings – a multi-disciplinary, global research program carried out by every NIH institute and center in accordance with their mission. This diverse research portfolio requires an unprecedented level of trans-NIH planning, scientific priority-setting, and resource management. The Office of AIDS Research (OAR) was authorized to plan, coordinate, evaluate, and budget all NIH AIDS research, functioning as an “institute without walls,” to identify the highest priority areas of scientific opportunity, enhance collaboration, minimize duplication, and ensure that precious research dollars are invested effectively and efficiently.
The Trans-NIH AIDS Research Program
To address this pandemic, NIH has established the largest and most significant AIDS research program in the world, a comprehensive program of basic, clinical, translational, and behavioral research in domestic and international settings – a multi-disciplinary, global research program carried out by every NIH institute and center in accordance with their mission. This diverse research portfolio requires an unprecedented level of trans-NIH planning, scientific priority-setting, and resource management. The Office of AIDS Research (OAR) was authorized to plan, coordinate, evaluate, and budget all NIH AIDS research, functioning as an “institute without walls,” to identify the highest priority areas of scientific opportunity, enhance collaboration, minimize duplication, and ensure that precious research dollars are invested effectively and efficiently.
The Trans-NIH Plan and Budget Based on Scientific Priorities
OAR’s trans-NIH strategic planning process, involving both government and non-government experts, results in the identification of clear, overarching AIDS-research priorities and specific research objectives and strategies. The priorities of the annual strategic Plan (http://www.oar.nih.gov/strategicplan/) guide the development of the trans-NIH AIDS research budget. OAR develops each IC’s AIDS research allocation based on the Plan, scientific opportunities, and the IC’s capacity to absorb and expend resources for the most meritorious science – not on a formula. This process reduces redundancy, promotes harmonization, and assures cross-Institute collaboration.
FY 2008 Priorities
The overarching research priorities of the FY 2011 Trans-NIH Strategic Plan that frame the budget will establish the scientific foundation to achieve the goals of the President’s National AIDS Strategy. These priorities are also aligned with the NIH Director’s themes. They are:
Expanding Basic Discovery Research: NIH will continue its strong commitment to basic science, which is fundamental to the mission of NIH and essential to enable innovation, address critical gaps, and capitalize on emerging scientific opportunities. Research is needed to better understand the virus and how it causes disease, including studies to delineate how gender, age, ethnicity, and race influence vulnerability to infection and HIV disease progression. OAR has provided increased support for genomics studies and breakthroughs in sequencing the human genome, and for new opportunities to apply these valuable tools to the search for new HIV prevention and therapeutics strategies.
Reducing New Infections: Prevention of new HIV infections remains a top priority for NIH research. A vaccine that prevents the acquisition of HIV is our best hope for ending the pandemic, but we also must work with and improve the many HIV prevention tools currently available, and add new ones to the toolbox. The key areas of prevention research include: vaccines, microbicides, and behavioral and social science. A critical new area is the study of treatment strategies as a method to prevent new infections. These include: post-exposure prophylaxis, the use of treatment to prevent HIV infection after exposure, including in a healthcare environment; pre-exposure prophylaxis (PreP), the long-term use of treatment regimens for high-risk uninfected populations to prevent HIV acquisition; and a potential prevention strategy known as “test and treat,” to determine whether a community-wide testing program with immediate treatment can decrease the overall rate of new HIV infections in that community.
Improving Disease Outcomes: A growing proportion of patients receiving long-term antiretroviral therapy (ART) are demonstrating treatment failure, experiencing serious drug toxicities and side effects, and developing drug resistance. Recent studies have shown an increased incidence of malignancies, as well as cardiovascular and metabolic complications, and premature aging associated with long-term HIV disease and ART. NIH research will address the need to develop better, less toxic treatments and to investigate how genetic determinants, sex, gender, race, age, pregnancy status, nutritional status, and other factors interact to affect treatment success or failure and/or disease progression.
Reducing HIV-Related Disparities: NIH-funded research is needed to address the causes of HIV-related health disparities, their role in disease transmission and acquisition, and their impact on treatment access and effectiveness. These include disparities among racial and ethnic populations in the U.S.; between developed and resource-constrained nations; between men and women; between youth and older individuals; and disparities based on sexual identity. NIH will support research training for new investigators from racial and ethnic communities, development of research infrastructure, community outreach, information dissemination, workshops, leadership development, and research collaborations to help reduce these disparities.
Translating Research from Bench to Bedside to Community: OAR has provided funds to the Institutes and Centers to focus on analyses of the feasibility, effectiveness, and sustainability required for the scale-up and implementation of interventions from a structured behavioral or clinical study to a broader "real world" setting; These include critical epidemiologic and natural history studies to evaluate various operational strategies that can be employed to scale up and evaluate ART programs and successful prevention interventions in communities at risk. Effective information dissemination approaches are integral to HIV prevention and treatment efforts and critical in light of the continuing advent of new and complex antiretroviral treatment regimens, issues related to adherence to prescribed treatments, and the need to translate behavioral and social prevention approaches into practice.
Global Health
Research to address the global HIV pandemic is essential. Since the early days of the epidemic, beginning in 1983 with a research project in Haiti and the establishment of Project SIDA in 1985 in what was then Zaire, NIH has maintained a strong international AIDS research portfolio. NIH has expanded this effort to encompass projects in approximately 100 countries around the world.
Summary
The NIH investment in AIDS research is reaping even greater dividends in unraveling the mysteries surrounding many other cardiovascular, malignant, neurologic, autoimmune, metabolic, and infectious diseases as well as complex issues of aging and dementia. For example, AIDS research has provided an entirely new paradigm for drug design, development, and clinical trials to treat viral infections. Drugs developed to prevent and treat AIDS-associated opportunistic infections also benefit patients undergoing cancer chemotherapy or receiving anti-transplant rejection therapy; and AIDS research is providing a new understanding of the relationship between viruses and cancer.
The AIDS pandemic, the deadliest epidemic of our generation, will continue to wreak devastating consequences around the world for decades to come in virtually every sector of society. The OAR has utilized its unique authorities to shift AIDS research program priorities and resources to meet the changing epidemic and scientific opportunities. This investment in AIDS research has produced groundbreaking scientific advances. However, serious challenges lie ahead. NIH will continue to focus on the need for comprehensive strategies to decrease HIV transmission and improve treatment options and treatment outcomes in affected vulnerable populations in the U.S. and in international settings.
We are deeply grateful for the support the Administration and this Committee have provided to our efforts.
Jack E. Whitescarver, Ph.D.
Director
Office of AIDS Research
National Institutes of Health
Dr. Whitescarver received his doctorate in medical microbiology in 1974 from the University of Medicine and Dentistry of New Jersey (UMDNJ), Graduate School of Biomedical Sciences. He pursued his post-doctoral research at the Harvard School of Public Health, focusing on immunopathogenesis of rickettsia infection. In his position as a Research Associate at the Harvard School of Public Health and Medical School, Dr. Whitescarver’s research interests included obligate intracellular parasites. His published research results include in vitro studies on breast tumors, spirochetes, mycoplasmas, and rickettsia.
In 1977, Dr. Whitescarver completed a year in the Grants Associates Program at the National Institutes of Health (NIH) and became the Special Assistant to the Director of the National Institute of Allergy and Infectious Diseases (NIAID). In that position he was responsible for assisting the Director in policy, planning and budget issues. It was during this tenure that Dr. Whitescarver first reported to the NIAID on the possibility of the emergence of a new infectious disease, now known as AIDS, and he helped develop the initial federal response for research on AIDS.
From 1984 to 1988, Dr. Whitescarver held the positions of Associate Dean for Research Development and Assistant Professor of Pathology at Emory University School of Medicine. His duties as Associate Dean included directing the M.D. /Ph.D. training program and facilitating new research initiatives, particularly in AIDS.
In 1988, the new Office of AIDS Research (OAR) at the NIH was established, and Dr. Whitescarver was recruited as the Deputy Director. He served as Acting Director of the OAR from October 2000 until June 2002, when he was named permanent Director. Under his leadership, OAR has launched a number of innovative domestic and international initiatives. It is the role of the OAR to plan and coordinate the trans-NIH research program sponsored by all of the more than twenty NIH Institutes and Centers. Dr. Whitescarver is a member of several professional societies including the American Academy of Allergy and Immunology, Infectious Diseases Society of America, the Royal Society of Medicine, and the International AIDS Society. He has received numerous honors and awards including the Alumnus of the Year Award from the UMDNJ Graduate School of Biomedical Sciences and the Award for Distinguished Service from the Secretary of the Department of Health and Human Services.