FY 2012 Congressional Appropriations Testimony
Witness appearing before the
Senate Subcommittee on Labor-HHS-Education Appropriations
Jack Whitescarver, Ph.D., Director
Office of AIDS Research
May 11, 2011
Mr. Chairman and Members of the Committee:
I am pleased to present the Fiscal Year (FY) 2012 President's budget request for the trans-NIH AIDS research program, which is $3,159,531,000. This amount is an increase of $100,254,000 over the FY 2011 Enacted level. It includes the total NIH funding for research on HIV/AIDS and the wide spectrum of AIDS-associated malignancies, opportunistic infections, co-infections, and clinical complications; intramural and extramural research; research management support; research centers; and training. It also includes a transfer of approximately $27 million to the HHS Office of the Assistant Secretary of Health to foster collaborations across HHS agencies and finance high priority initiatives in support of the President’s National HIV/AIDS Strategy.
The AIDS Pandemic
Nearly 30 years since the recognition of AIDS and the identification of HIV as its causative agent, the HIV/AIDS pandemic remains a global scourge. UNAIDS reports that in 2009, more than 33 million people were estimated to be living with HIV/AIDS; 2.6 million were newly infected; and 1.8 million people died of AIDS-related illnesses. The majority of cases worldwide are the result of heterosexual transmission, and women represent more than 50% of HIV infections worldwide. More than 1,000 children become infected each day, most of them as newborns. More than 25 million men, women, and children worldwide have already died.
In the United States, CDC reports that more than 1.1 million people are estimated to be HIV-infected; approximately 56,300 new infections occur each year; and someone is infected with HIV every nine and a half minutes. HIV/AIDS continues to be an unrelenting public health crisis, disproportionately affecting 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.
NIH AIDS Research Program
To address this pandemic, NIH has established the 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.
New Scientific Advances and Opportunities
The past year has been a significant one for AIDS research. The NIH investment in the priority areas of HIV prevention research and in basic science over the past several years has resulted in important progress in critical areas of the NIH AIDS research program. Recent research advances by NIH intramural and extramural investigators have opened doors for new and exciting research opportunities in the search for strategies to prevent, treat, and ultimately cure HIV infection. These advances include:
- Technologies to accelerate discovery – (1) Vaccines: A team of scientists led by researchers at the NIAID Vaccine Research Center discovered two potent human antibodies that can stop more than 90 percent of known global HIV strains from infecting human cells in the laboratory and determined the structural analysis of how they work. The novel techniques used in this research may accelerate HIV vaccine research as well as the development of vaccines for other infectious diseases. An HIV vaccine clinical trial conducted in Thailand by NIH and the Department of Defense demonstrated the first indication of a modest but positive effect in preventing HIV infection. The trial marked the first step in proving the concept that a vaccine to prevent HIV infection is feasible.
- (2) Microbicides: For the first time in nearly 15 years of research, scientists discovered a vaginal microbicide gel that gives women a level of protection against HIV infection. The study, sponsored by USAID and conducted by the Centre for the AIDS Programme of Research in South Africa (CAPRISA), found that the use of a microbicide gel containing the antiretroviral drug tenofovir resulted in 39 percent fewer HIV infections compared with a placebo gel. NIH provided substantial support and resources to establish the infrastructure and training for CAPRISA. Ongoing and future NIH clinical trials will build on these study results with the goal of bringing a safe and effective microbicide to licensure.
- (3) Basic Science: This past year, using genome-wide association studies, NIH-sponsored researchers made an important discovery related to the genetics of an individual’s immune system. These genes appear to be involved in the control of HIV disease progression among a group of individuals considered “elite controllers,” who have been exposed to HIV over an extended period, but whose immune systems have controlled the infection without therapy and without symptoms. These findings will contribute to the development of potential HIV prevention strategies.
- Translational sciences and therapeutic development: New lymphoma regimens have been developed that can be tailored to specific tumor types. This development has markedly improved the therapeutic outcome and survival of patients with AIDS-related lymphoma. In addition, progress in both basic science and treatment research aimed at eliminating viral reservoirs has been significant enough that scientists are now, for the first time, planning to conduct research aimed at a cure. NIH has announced several initiatives to generate new ideas for curing HIV infection through domestic and international partnerships among government, industry, and academia.
- Enhancement of evidence-base for health care decisions: In the critical area of treatment as prevention, two recent studies have demonstrated the effectiveness of new multi-drug antiretroviral regimens for the prevention of mother-to-child-transmission of HIV during pregnancy and breastfeeding. In addition, a large international NIH clinical trial provided strong evidence that the use of pre-exposure prophylaxis (PrEP), that is, the use of antiretroviral treatment before exposure to prevent infection, can reduce risk of HIV acquisition in men who have sex with men. Additional and continued research is needed to determine whether PrEP will be similarly effective at preventing HIV infection in other at-risk populations and assist health care workers in providing these potential options.
Trans-NIH Plan and Budget
These advances, while preliminary and incremental, provide the groundwork for further scientific investigation and the building blocks for the development of the trans-NIH AIDS strategic Plan, developed by OAR in collaboration with both government and non-government experts. The priorities of the strategic Plan 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. The priorities of the Plan will establish the biomedical and behavioral research foundation necessary to implement the major goals of the President’s National HIV/AIDS Strategy and to implement the NIH Director’s themes.
FY 2012 Scientific Priorities
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.
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. In addition, specific FY 2012 research priorities include:
- biomedical and behavioral research focused on the domestic AIDS epidemic, particularly in racial and ethnic populations of the U.S.;
- research to build on important research advances in prevention research in the past year in the areas of microbicides, vaccines, and treatment as prevention;
- research to prevent and treat HIV-associated co-morbidities, malignancies, and clinical complications;
- research to address the complex issues around AIDS and aging;
- research to better understand the issues of adolescents and AIDS;
- basic and therapeutic research focused on elimination of viral reservoirs leading toward a cure;
- genetic studies to delineate the genetic basis for immune responses to HIV and to sequence HIV-associated tumors; and
- research on feasibility, effectiveness, and sustainability required for the scale-up and implementation of interventions in communities at risk.
Summary
The OAR has utilized its 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. AIDS research also is helping to unravel the mysteries surrounding many other cardiovascular, malignant, neurologic, autoimmune, metabolic, and infectious diseases as well as the complex issues of aging and dementia. Despite these advances, however, AIDS has not been conquered, and serious challenges lie ahead. The HIV/AIDS pandemic will remain the most serious public health crisis of our time until better, more effective, and affordable prevention and treatment regimens are developed and universally available. NIH will continue its efforts to prevent, treat, and eventually cure AIDS.
Thank you for your continuing support for our efforts.
Jack E. Whitescarver, Ph.D.
Associate Director for AIDS Research and
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. 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. Last year he was awarded the first International AIDS Society Presidential Award for his commitment to the global fight against HIV and his pioneering work in the field.