FY 2008 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 6, 2007
Mr. Chairman and Members of the Committee:
I am pleased to present the Fiscal Year 2008 President's budget request for the trans-NIH AIDS research program is $2,905,219,000. This amount 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 Pandemic
The AIDS pandemic will continue to wreak devastating consequences around the world for decades to come in virtually every sector of society, affecting the future of families, communities, agriculture, business, healthcare, child development, education, national security, military preparedness, political stability, and national economic growth in countries around the globe. 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 addition to the OAR total, the NIH will contribute $300 million to the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria in FY 2008. In the United States, CDC reports that 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. The use of antiretroviral therapy is now associated with a series of side effects and long-term complications that may have a negative impact on mortality rates. The appearance of multi-drug resistant strains of HIV presents an additional serious public health concern. According to CDC reports, approximately one quarter of the HIV-infected population in the United States also is infected with hepatitis C virus (HCV). These data forebode an epidemic of even greater magnitude in the coming years.
The Trans-NIH AIDS Research Program
NIH is the world’s leader in AIDS research, representing the largest and most significant public investment in AIDS research in the world. Our response to the pandemic requires a unique and complex multi-institute, multi-disciplinary, global research program. NIH supports a comprehensive program of basic, clinical, and behavioral research on HIV infection, its associated co-infections, opportunistic infections, malignancies, and other complications. Perhaps no other disease so thoroughly transcends every area of clinical medicine and basic scientific investigation, crossing the boundaries of nearly every NIH Institute and Center (IC). This diverse research portfolio demands an unprecedented level of scientific coordination and management of research funds. The Office of AIDS Research (OAR), located within the Office of the Director, coordinates the scientific, budgetary, and policy elements of NIH AIDS research. Through its unique, trans-NIH planning, budgeting, and portfolio assessment processes, OAR ensures that research dollars are invested in the highest priority areas of scientific opportunity. As such, the OAR represents the roadmap for NIH AIDS research, allowing NIH to pursue a united research front against the pandemic.
Setting Research Priorities: Unique Trans-NIH Processes
OAR develops the annual Trans-NIH Plan for HIV-Related Research, in collaboration with the ICs, non-government experts from academia, foundations, and industry, as well as community representatives. The Plan and the unique processes instituted by OAR to ensure its implementation allow NIH to pursue a united research front against the global AIDS epidemic. The Plan serves as the framework for developing the annual NIH AIDS budget; for determining the use of NIH AIDS-designated dollars; for tracking and monitoring expenditures; and for informing the scientific community, the public, and the AIDS-affected community about NIH AIDS research priorities. The over-arching themes of the AIDS research plan are: a strong foundation of basic science; research to prevent and reduce HIV transmission, including microbicides, vaccines, and behavioral interventions; research to develop better therapies for those who are already infected; research in international settings, particularly to address the pandemic in developing countries; and research targeting the disproportionate impact of AIDS on minority populations in the United States. The ICs submit their AIDS budget requests to OAR, and OAR allocates budgets to the ICs at each step of the budget development process based not on a formula, but on the priorities of the Plan, scientific opportunities, and the IC’s capacity to absorb and expend resources for the most meritorious science. As part of the annual planning process, OAR conducted a multi-tiered trans-NIH review of all grants and contracts supported with AIDS-designated funds scheduled to recompete in FY 2008. OAR convened a group of eminent non-government experts to assist in this task to identify those grants that are now of lower priority based on the current state of the epidemic and scientific opportunities.
FY 2008 Priorities
As a result of these trans-NIH planning, budget, and portfolio analysis processes, OAR shifted funds across ICs and across activities to ensure that the highest scientific priorities are supported in FY 2008. These priorities are primarily in the area of HIV prevention research, particularly the development of microbicides and vaccines. The AIDS pandemic continues to expand worldwide, and will only be slowed or halted through these critical prevention strategies. Within the total budget request, the funding priorities are microbicides and vaccine research. In order to provide increases for these activities, funding for the areas of behavioral and social science, and for etiology and pathogenesis are maintained; and funds have been reduced for all other activity areas.
Prevention Research
Microbicides: The vulnerability of women to acquiring HIV infection requires the development of safe, effective, and acceptable female-controlled chemical and physical barrier methods, such as topical microbicides, to reduce HIV transmission. In addition to providing increased funding in this area of science, OAR will use its authorities to improve NIH management and support for microbicide research. A separate division of OAR now will be dedicated to microbicide research and other issues relevant to women. OAR is convening a newly constituted NIH Microbicide Research Coordinating Committee with members from the ICs with significant microbicide portfolios, as well as CDC and USAID. The Committee will assist in the development of the microbicides component of the Plan, foster information-sharing and trans-NIH coordination, and help identify scientific opportunities and gaps for increased attention. A Microbicide Research Working Group is being established of non-government experts to advise the OAR, the National Institute of Allergy and Infectious Diseases (NIAID), the NIH, and other government and non-government entities in this priority area. In addition, the NIAID Division of AIDS (DAIDS) is developing a new Prevention Sciences Program, which will include a Microbicide Research Branch. NIH will increase collaborations with academia, industry, and foundations to identify and explore new and existing compounds as potential topical microbicidal agents.
Vaccines: Safe and efficacious vaccines are essential for global control of the AIDS pandemic. AIDS vaccine research has been the highest priority for the past several years, and has received significant increases to ensure that new and innovative concepts continue to advance through the pipeline. This request places highest priority on the discovery, development, and testing of additional HIV vaccine candidates, including funding to move promising vaccine candidates into large-scale clinical trials to evaluate their potential for safety and efficacy.
Behavioral Research: Behavioral research priorities include studies to develop and test effective HIV-related interventions that build on studies of substance addiction and the complex interaction of alcohol use, drug use, and disinhibition, as well as research issues associated with adherence to therapies. To support these behavioral research priorities, OAR has redirected funds from expiring grants in lower priority areas.
Therapeutics Research
Important challenges still remain in the area of therapeutics research. A high priority of NIH-sponsored AIDS therapeutics research continues to be the development of better drugs and therapeutic regimens that are less toxic and have fewer side effects, limit the development of drug resistance, enter viral reservoirs to inhibit viral replication, promote easier adherence, and are more readily accessible. A growing proportion of patients receiving therapy are demonstrating treatment failure, experiencing serious drug toxicities and side effects, and developing drug resistance. The increasing incidence of metabolic disorders, cardiovascular complications, major organ dysfunction, and physical changes associated with current antiretroviral drugs underscores the critical need for new and better treatment regimens. NIH is continuing to develop regimens to prevent mother-to-child transmission that can be implemented in resource-constrained nations, including strategies to prevent transmission associated with breast-feeding. A restructured clinical trials network for the conduct of perinatal, pediatric, and maternal clinical studies will place a greater emphasis on sites in developing countries. To support these initiatives, funds will be redirected from expiring grants that supported basic research on coinfections and opportunistic infections. Those studies provided important findings that contributed to the development of regimens for the prevention and treatment of these infections; however, the incidence of these infections in HIV-infected individuals in the U.S. has diminished as a result of the effectiveness of antiretroviral treatments.
Research in Specific Populations
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, including women, minority populations in the U.S., and in international settings. These interventions will address the co-occurrence of other STDs, 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.
Summary
OAR is enhancing trans-NIH collaboration, minimizing duplication, and ensuring that research dollars are invested in the highest priority areas of scientific opportunity that will lead to new tools in the fight against AIDS. The legislative authorities of the OAR allow NIH to pursue a united research front against the global AIDS epidemic.
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.