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FY 2010 Congressional Testimony

Witness appearing before the
Senate Subcommittee on Labor-HHS-Education Appropriations

NIH Associate Director for AIDS Research and
Director, Office of AIDS Research

May 21, 2009


Mr. Chairman and Members of the Committee:

I am pleased to present the President’s Fiscal Year 2010 Budget request for the trans-NIH AIDS research program of the National Institutes of Health (NIH). The FY 2010 budget includes $3,055,494,000, which is $45,155,000 more than the FY 2009 appropriation of $3,010,339,000.

The AIDS Pandemic

More than 33 million people around the world are estimated to be currently living with HIV/AIDS infection. More than 25 million men, women, and children have already died. The pandemic affects the future of families, communities, military preparedness, national security, political stability, national economic growth, agriculture, business, health care, child development, and education in countries around the globe. As a result of multilateral and bilateral programs in low- and middle-income countries, almost three million people now have access to antiretroviral drug treatment. However, for every one person who starts taking antiretroviral drugs, another three become infected.

In the United States, HIV/AIDS remains an unrelenting public health crisis. CDC reports over 1.1 million people are infected with the virus, with approximately 56,300 new infections each year. According to CDC statistics, African American men and women and gay and bisexual men of all races and ethnicities are the most affected groups in the United States. It is estimated that one out of every 20 individuals in the District of Columbia is HIV-infected – a vivid example of the impact of AIDS on minority populations in the United States.

The Trans-NIH AIDS Research Program

The NIH AIDS research program is the largest in the world – a unique and complex multi-Institute, multi-disciplinary, global research program. Perhaps no other disease so thoroughly transcends every area of clinical medicine and basic scientific investigation. AIDS research is carried out by nearly all of the NIH institutes and centers in accordance with their mission. This diverse research portfolio requires an unprecedented level of scientific coordination and management of research. The Office of AIDS Research (OAR) was authorized to plan, coordinate, evaluate, and budget all NIH AIDS research, functioning as an “institute without walls,” allowing NIH to pursue a unified research program to prevent and treat HIV infection and its associated complications. OAR has established comprehensive trans-NIH planning, portfolio analysis, and budgeting processes 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 research priorities that frame this trans-NIH budget request were established through the annual OAR strategic planning process, involving scientists from NIH, other government agencies, academia, industry, and non-governmental organizations, as well as community representatives.

FY 2010 Research Priorities: Prevention Research

Prevention of HIV infection is NIH’s highest priority for HIV-related research. Disappointing results from recent clinical studies of HIV vaccine and microbicide candidates underscore the need for additional discovery (basic) research on HIV and the host immune response. Biomedical and behavioral interventions are urgently needed to reach individuals at risk, particularly in racial and ethnic populations in the United States, in international settings, among women, and among men who have sex with men. Priority areas include:

FY 2010 Priorities: Therapeutics Research

Antiretroviral treatment has resulted in improved immune function in patients who are able to adhere to the treatment regimens and tolerate the toxicities associated with antiretroviral drugs; and it has delayed the progression of HIV disease, extending the time between initial infection and the development of AIDS. However, a growing proportion of patients receiving therapy are demonstrating treatment failure, experiencing serious drug toxicities and side effects, and developing drug resistance. A critical area of research is the use of antiretroviral therapy as prevention. This includes evaluating the use of therapeutic regimens after exposure to HIV (post-exposure prophylaxis), as well as testing the concept of the use of antiretroviral therapy in high risk individuals prior to HIV exposure (pre-exposure prophylaxis).

Epidemiologic studies have revealed a number of co-infections and co-morbidities associated with long-term HIV disease, including tuberculosis, hepatitis C, malignancies, metabolic disorders, cardiovascular disease, and neurologic disorders. A better understanding of the underlying etiology of these HIV-associated conditions will lead to better prevention and treatment strategies. NIH supports a comprehensive therapeutics research program to design, develop, and test drugs and drug regimens to prevent and treat HIV infection and its associated co-infections and co-morbidities.

Translational and clinical studies also are needed to transform fundamental research results into improved strategies for preventing and treating these HIV-associated complications, including research on drug resistance, drug toxicities, pharmacogenomics, adherence, and the interrelatedness of HIV and nutrition.

Discovery Research: Enabling Innovation

A renewed emphasis on discovery research is essential to enable innovation, address critical gaps, and capitalize on emerging scientific opportunities. Ground-breaking strides have been made towards understanding the fundamental steps in the life-cycle of HIV, the host-virus interactions, and the clinical manifestations associated with HIV infection and AIDS. However, additional research is needed to further the understanding of 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. NIH-supported genomics studies and breakthroughs in sequencing the human genome provide new opportunities to apply these valuable tools to the search for new HIV prevention and therapeutics strategies. OAR proposes to capitalize on those opportunities by providing funds for new, exciting areas of investigation, including studies utilizing genomics tools to investigate the immune response to HIV infection.

Research Training and Community Outreach

NIH must continue to support training programs for U.S. and international researchers to build the critical capacity to conduct AIDS research both in racial and ethnic communities in the United States and in developing countries. NIH-funded programs have increased the number of training positions for AIDS-related research, including programs specifically designed to recruit individuals from underrepresented populations into research careers and to build research infrastructure at minority-serving institutions in the United States. The changing pandemic and the increasing number of HIV infections among women and in racial and ethnic populations of the United States, particularly in African American and Latino/Hispanic communities, also underscore the need to disseminate HIV research findings and other related information to communities at risk.


NIH-sponsored HIV/AIDS research continues to provide the important scientific foundation necessary to design, develop, and evaluate new and better vaccine candidates, therapeutic agents and regimens, and prevention interventions. 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. These interventions will address the co-occurrence of other sexually transmitted diseases, hepatitis, drug abuse, and mental illness; and consider the role of culture, family, and other social factors in the transmission and prevention of these disorders.

The NIH investment in AIDS research is reaping even greater dividends in unraveling the mysteries surrounding many other infectious, malignant, neurologic, autoimmune, and metabolic diseases. 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 provide benefit to patients undergoing cancer chemotherapy or receiving anti-transplant rejection therapy. AIDS research also is providing a new understanding of the relationship between viruses and cancer. We are deeply grateful for the support the Administration and this Committee have provided to our efforts.

Jack E. Whitescarver, Ph.D.

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 nearly all of the more than twenty NIH Institutes and Centers.

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