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FY 2009 Congressional Testimony

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

JACK WHITESCARVER, PH.D.
NIH Associate Director for AIDS Research and
Director, Office of AIDS Research

March 5, 2008

Accompanied by Richard J. Turman, Deputy Assistant Secretary, Budget

 

Mr. Chairman and Members of the Committee:

I am pleased to present the Fiscal Year 2009 President's budget request for the trans-NIH AIDS research program, which is $2,913,345,000. This amount is unchanged from the FY 2008 Enacted level, and includes the total trans-NIH funding for intramural and extramural research, research management support, research centers, basic and clinical research on HIV/AIDS, as well as research on the wide spectrum of its associated malignancies, opportunistic infections, co-infections, and clinical complications.

The Worldwide AIDS Pandemic

The United Nations General Assembly's Declaration of Commitment on HIV/AIDS states, “...the global HIV/AIDS epidemic, through its devastating scale and impact, constitutes a global emergency and one of the most formidable challenges to human life and dignity, as well as to the effective enjoyment of human rights, which undermines social and economic development throughout the world and affects all levels of society…”

In the United States, CDC reports over a million people are infected with the virus, and the rate of new infections has not declined for more than a decade. HIV infection rates are continuing to climb among women, racial and ethnic minorities, young men who have sex with men, individuals with addictive disorders, and people over 50 years of age. It is estimated that one out of every 20 individuals in the District of Columbia is HIV-infected -- providing a vivid example of the impact of AIDS on minority populations in the United States. This staggering rate is similar to that of nations in sub-Saharan Africa.

The Trans-NIH AIDS Research Program

In response to this pandemic, the NIH has made the largest and most significant public investment in AIDS research 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, crossing the boundaries of the NIH Institutes and Centers (ICs). This diverse research portfolio demands an unprecedented level of scientific coordination and management of research. This is recognized in the unique role given the Office of AIDS Research (OAR), which was authorized to plan, coordinate, and evaluate all AIDS research conducted or supported by NIH, allowing NIH to pursue a coordinated and unified research program aimed at developing ways to prevent and treat HIV infection and its associated complications.

FY 2009 Research Priorities

The coordination and harmonization of NIH research efforts are even more critical in order to preserve and maintain support for the highest scientific priorities in a time of fiscal constraint. The research priorities that frame this budget request were established through the annual OAR strategic planning process, involving scientists from NIH, other government agencies, and non-governmental organizations, as well as community representatives. The annual process culminates with the identification of the top strategic priorities and critical research needs. Two critical priorities emerged during the strategic planning process and shaped the development of the FY 2009 budget request:

OAR shifted funds across activities to ensure that these priorities are supported in FY 2009, and in particular, to support the necessary basic science base, including a new focus utilizing genomics tools to investigate the immune response to HIV infection. This budget request represents a philosophical shift and redirection of focus necessitated by recent research results, scientific opportunities, and financial constraints.

Prevention Research

Microbicides: Microbicides, antimicrobial products that can be applied topically for the prevention of HIV and other sexually transmitted infections, may offer one of the most promising primary preventive interventions. NIH supports a comprehensive microbicide research program that includes the screening, discovery, development, preclinical testing, and clinical evaluation of microbicide candidates, as well as fundamental research aimed at understanding how HIV transverses mucosal membranes and infects cells. In addition, NIH supports behavioral and social science research on the acceptability and use of microbicides among different populations. However, recent clinical trial results of microbicide candidates have been disappointing, and demonstrate the need for renewed and intensified efforts to fund additional research to understand basic science questions and develop new approaches to designing microbicides. NIH has initiated a series of administrative steps to increase the level of awareness and focus on microbicide research, including: the establishment of a Microbicide Research Working Group, comprised of non-government experts who will play a unique and critical role in guiding the formulation of the NIH microbicide agenda; establishment of a new microbicide research branch at NIAID; and the Microbicide Innovation Program, designed to accelerate the discovery and development of single and/or combination microbicides.

Vaccines: The best long-term hope for controlling the AIDS pandemic is the development of safe, effective, and affordable HIV vaccines. AIDS vaccine research remains a high priority to ensure that new and innovative concepts continue to advance through the pipeline. NIH supports a broad HIV vaccine research portfolio encompassing basic, preclinical, and clinical research. In FY 2007, NIH supported a number of Phase I, II, and IIb clinical trials. Two large studies conducted by NIH in partnership with Merck & Co., Inc. were halted by the Data and Safety Monitoring Board after interim analyses of data because the vaccine candidate did not prevent HIV infection. Although disappointing, the results from these clinical studies underscore the critical need to invest in basic research on the virus and host immune responses that can inform the development of new and innovative vaccine concepts; as well as the development of improved animal models to conduct pre-clinical evaluations of vaccine candidates. One such important study is ongoing at the NIH Dale and Betty Bumpers Vaccine Research Center (VRC). NIH intramural scientists at the VRC determined the long-sought picture of the precise interaction of the HIV surface protein gp120 as it looks when bound to an infection-fighting antibody, a finding that could have profound implications for HIV vaccine design. In addition, researchers at the NIH-sponsored Center for HIV/AIDS Vaccine Immunology (CHAVI) recently reported significant findings from genomics experiments comparing the genome of long-term non-progressors to those who experienced rapid disease progression. These results highlight the urgent need for an increased emphasis on genomic studies of the human immune system.

Behavioral Research: NIH supports research to further our understanding of how to change the behaviors that lead to HIV acquisition, transmission, and disease progression—including preventing their initiation—and how to maintain protective behaviors once they are adopted. In addition, NIH supports research aimed at better understanding the social and cultural factors associated with HIV risk or protection, particularly in communities at high risk of HIV acquisition. This research will contribute to the implementation of a broader range of preventive and/or therapeutic strategies.

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. 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.

Funding for therapeutics research will be decreased in FY 2009 in order to increase funding for HIV prevention research, which was determined through the OAR FY 2009 trans-NIH strategic planning process to be NIH’s top priority for HIV-related research. A realignment of funding between research program areas is necessary in order to fund top priority HIV-related research. Therefore in FY 2009, funds will be re-allocated to support HIV prevention research, which includes the microbicide, vaccine, and behavioral and social science research programs.

Discovery Research: Enabling Innovation

As mentioned above, the results from recent microbicide and vaccine clinical studies have revealed gaps in knowledge and understanding of HIV etiology and pathogenesis, particularly with regard to host immune responses and how HIV interacts with and transverses mucosal surfaces. Although 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; 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. At the same time, 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. Thus, OAR proposes to capitalize on those opportunities by providing funds for new, exciting areas of investigation, including a new program to utilize genomics tools to investigate the immune response to HIV infection. Maintaining essential AIDS research programs while attempting to address new scientific opportunities, most notably the tools developed in the human genome studies, presents a daunting challenge. A renewed emphasis on discovery research is essential to enable innovation, address critical gaps, and capitalize on emerging scientific opportunities.

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. In response to the AIDS pandemic, NIH has developed a comprehensive biomedical and behavioral research program to better understand the basic biology of HIV, develop effective therapies to treat it, and design interventions to prevent new infections from occurring. It is the role of the OAR to plan and coordinate this 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, 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.

Department of Health and Human Services
Office of Budget
Richard J. Turman

Mr. Turman is the Deputy Assistant Secretary for Budget, HHS. He joined federal service as a Presidential Management Intern in 1987 at the Office of Management and Budget, where he worked as a Budget Examiner and later as a Branch Chief. He has worked as a Legislative Assistant in the Senate, as the Director of Federal Relations for an association of research universities, and as the Associate Director for Budget of the National Institutes of Health. He received a Bachelor’s Degree from the University of California, Santa Cruz, and a Masters in Public Policy from the University of California, Berkeley.

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