DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Statement by
Anthony S. Fauci, M.D.
Director
National Institute of Allergy and Infectious Diseases
To the U.S. House Appropriations Subcommittee
on Labor, HHS, & Education
March 18, 1998
Mr. Chairman and Members of the Committee:
I am pleased to present the President’s budget request for the National Institute of Allergy and Infectious Diseases (NIAID) for Fiscal Year 1999. The President proposes that the NIAID receive $702 million, an increase of 8.0 percent for NIAID non-AIDS research activities. Including the estimated allocation for AIDS research activities, total support proposed for the NIAID is $1.47 billion, an increase of 8.6 percent over the comparable FY 1998 appropriation. Funds for NIAID AIDS research efforts are included in the Office of AIDS Research budget request.
The activities of the NIAID are covered by the NIH-wide Annual Performance Plan required under the Government Performance and Results Act (GPRA). The FY 1999 performance goals and measures for NIH are detailed in this performance plan and are linked to the HHS GPRA Strategic Plan which was transmitted to Congress on September 30, 1997. The NIAID is anxious to meet the challenges set forth in this plan and we look forward to continued support from Congress that will facilitate our achieving these goals.
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Fifty Years: Advancing Knowledge, Improving Health
This year, the NIAID celebrates fifty years of progress in understanding, treating and preventing infectious and immunologic diseases. During the past five decades, NIAID-supported research in fields such as microbiology and immunology has led to new therapies, vaccines and diagnostic tools that have profoundly benefited global health. Capping this remarkable half-century are recent advances and initiatives that promise to further reduce the burden of disease in this country and around the world. Meanwhile, new challenges to the public health continue to emerge, underscoring the need for continued progress in our fight against infectious microbes and diseases of the immune system.
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Immunologic Tolerance
A long-standing goal of NIAID-supported immunology research is the development of new and better ways to prevent the rejection of transplanted organs and tissue "grafts" by the immune system. While current immunosuppressive drugs have greatly reduced graft rejection, these agents are highly toxic and increase a patient's risk of infection, cancer and other complications. In addition, despite major improvements in immunosuppressive therapy, 10 to 50 percent of transplanted organs and tissues are rejected by patients' immune systems within the first year. Even with the latest immunosuppressive drugs, approximately 60 percent of transplanted kidneys, the organ most often transplanted, are rejected within 10 years.
As we work to improve this record, we are encouraged by new findings, underpinned by years of basic immunology research, that show the feasibility of a totally new approach to preventing graft rejection. NIAID-supported researchers have demonstrated that it is possible to induce immunologic "tolerance" to a graft by turning off the specific immune responses that would otherwise attack it. Promising results in animal models have been achieved with transplanted kidneys and livers; early human studies suggest that long-term tolerance of transplanted bone marrow may be achieved with appropriate therapy.
One approach to inducing tolerance is to block the second of two signals needed by T cells to become activated and orchestrate an attack on a foreign tissue or organ. In this regard, several different blocking molecules have shown considerable promise. Other approaches to inducing tolerance involve manipulating immune system molecules called cytokines, or inducing the suicide of the immune cells that otherwise would attack a graft. The refinement of strategies for inducing tolerance could revolutionize the field of transplantation and benefit the tens of thousands of patients whose lives could be saved or improved by a donated organ. In addition, our growing knowledge of immune tolerance will help in understanding and treating other conditions such as cancer, autoimmune conditions, and allergic and infectious diseases.
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The Burden of Infectious Diseases
It is underappreciated that infectious diseases remain the leadingkiller of people globally and the third leading cause of death in the United States. Of the approximately 52 million deaths worldwide in 1996, more than 17 million were due to infectious diseases, including approximately 9 million among children. In addition, a growing number of cancers and other chronic conditions have been attributed to infectious agents. For example, the bacterium Helicobacter pylori causes ulcers and stomach cancer, and Chlamydia pneumoniae has been implicated as a cause of artery-clogging plaques. Both hepatitis B virus and hepatitis C virus (HCV) can lead to liver cancer, and human papillomavirus is responsible for most cases of cervical cancer. In addition to their human toll, the financial burdens of infectious diseases are enormous. In the United States alone, costs associated with infectious diseases exceed an estimated $120 billion annually.
In the face of the enormous challenges posed by infectious diseases, the sustained commitment of NIAID to basic and applied research has paid enormous dividends against newly recognized pathogens--such as human immunodeficiency virus (HIV) and HCV--and scourges which have long plagued humanity, including malaria, tuberculosis and life-threatening infant diarrhea.
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Progress Against HIV/AIDS
HIV, the cause of the acquired immunodeficiency syndrome (AIDS), remains one of the greatest threats to global health. More than 30 million people worldwide are living with HIV/AIDS, a number expected to reach 40 million by the year 2000. In the 17 years since AIDS was recognized, an estimated 11.7 million people with HIV worldwide have died, including approximately 380,000 in the United States. Despite the mounting toll of HIV, recent developments have provided a measure of optimism. In the United States, AIDS deaths dropped 44 percent from the first six months of 1996 to the first six months of 1997; new AIDS diagnoses declined by 12 percent during the same period. These encouraging trends are probably due to several factors, notably the increased use of potent combinations of anti-HIV drugs, and our growing ability to prevent and treat the many secondary infections associated with HIV disease.
Basic research into the structure of HIV and how it interacts with the immune system led to the development of the 12 antiretroviral drugs now licensed in this country. Various combinations of these drugs, as well as several investigational drugs now in clinical trials, have helped restore the health of many patients, dramatically reducing the amount of HIV in their bodies and lowering their risk of secondary infections, hospitalizations and death. In addition, new insights into the pathogens that prey on the weakened immune systems of HIV-infected individuals have led to improved prophylactic and curative therapies.
Unfortunately, many HIV-infected individuals have not benefited from the currently available drugs, cannot tolerate their side effects, or have difficulty complying with complex treatment schedules that may require them to take 30 or more pills a day. In addition, the ability of HIV to mutate and become resistant to the current drugs is a persistent threat. Therefore, the development of the next generation of therapies--well-tolerated, effective drugs that can be administered with a minimum of doses for prolonged periods--remains a priority. Together with partners in academia and industry, NIAID-supported scientists are pursuing many new treatment strategies and exploring ways to boost an HIV-infected person's immune system.
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HIV Vaccine Research
In many developing countries, where health care spending may be only a few dollars per person each year, such therapies will probably remain beyond the reach of all but the most privileged. Therefore, continued research into an HIV vaccine and other means of preventing HIV infection is crucial to slowing the epidemic in these settings, as well as in our own country. To speed the pace of discovery, NIAID has strengthened its efforts in HIV vaccine research. Among recent initiatives are 58 new grants to foster innovative research on HIV vaccines and the establishment of a Vaccine Research Center within the NIH intramural research program.
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Hepatitis C
Another recently recognized pathogen of great concern is hepatitis C virus (HCV), identified in 1989. HCV is a leading cause of cirrhosis, liver cancer, and a major reason for liver transplants. Worldwide, more than 170 million people are chronically infected with HCV, including 4 million individuals in the United States. Annual HCV-related deaths number approximately 8,000 to 10,000 people in this country, a figure projected to reach 24,000 deaths/year by 2017 if effective therapies are not found. To combat this epidemic, NIAID recently established a network of Hepatitis C Research Centers to study the virus and how it causes disease. In the past year, researchers at one of the new centers reported a major breakthrough: the construction of functional, infectious clones of HCV, using genetic engineering techniques. This advance has facilitated HCV studies in cell cultures and animal models.
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Response to the Threat of H5N1 Avian Influenza
We have come to understand that the emergence of previously unrecognized pathogens such as HIV and HCV is a continual process. As further evidence of this, the first known cases of human influenza caused by a virulent bird virus known as H5N1 avian influenza were identified in Hong Kong in 1997. Given the possibility that this avian virus might combine with a human influenza strain and become more readily transmissible, possibly resulting in a pandemic, NIAID moved quickly with our colleagues at the Centers for Disease Control and Prevention, World Health Organization and other agencies in addressing research questions and public health needs associated with the outbreak. Fortuitously, as part of our long-standing research into respiratory viruses, we had in our repository the specific antisera needed to quickly develop test kits for detecting the avian influenza virus. NIAID has also supported the production of a recombinant vaccine for use in at-risk laboratory and health care personnel, as well as a surveillance effort in Hong Kong to identify and characterize the source of the avian virus.
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A Commitment to Malaria Research
More than 40 percent of the world's population lives in areas at risk for malaria transmission. Approximately 300 to 500 million cases of malaria occur worldwide each year; every 20 seconds, a child dies of the disease. In the past year, the National Institutes of Health, together with research organizations and donor agencies from around the world, have worked to mobilize the scientific resources and political will needed to control this dread disease. The extraordinary interest among scientists, political leaders, the media and the general public in this new partnership, called the Multilateral Initiative on Malaria, is strong evidence that the global community has recognized the magnitude of the malaria problem.
At NIAID, we have strengthened our long-term commitment to malaria research. NIAID-supported malaria projects--many in collaboration with other government and international agencies--include a new repository of malaria research materials that are available to researchers worldwide; basic, field-based and clinical research on all phases of malaria research; and projects to determine the genetic sequences of important malaria species. In addition, new collaborations between intramural and extramural scientists on malaria vaccine research, production and evaluation are underway.
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Diarrheal Diseases
Like malaria, diarrheal diseases are leading killers of children, resulting in about 2.5 million childhood deaths each year. At least a third of these deaths are probably due to rotavirus, a disease for which NIAID researchers have developed an effective, orally administered vaccine. As recently reported in The New England Journal of Medicine, this vaccine, the culmination of more than 20 years of research, reduced severe diarrheal illness by 88 percent in a study of infants in Venezuela, a country where rotavirus circulates year round. The vaccine is nearing licensure in the United States and other countries, and promises to have a major impact on the health of children worldwide. In the United States alone, widespread use of the NIAID-developed rotavirus vaccine could greatly reduce the 500,000 doctor visits and 100,000 hospitalizations related to rotavirus each year, as well as the $1.4 billion in direct and indirect costs associated with the illness.
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The Promise of New Technologies
Many of the advances I have described have been facilitated by rapid advances in molecular biology, notably the development of fast and accurate methods for sequencing the genomes of disease-causing microbes. Sequence information can be used in many ways, such as finding targets for therapies, identifying antigens to incorporate into vaccines, detecting mutations that cause drug resistance, and determining the factors that influence the virulence of a microbe.
The success of the first microbe sequencing project--the delineation of the complete Haemophilus influenzae genome in 1995--encouraged the Institute's current efforts to sequence the full genomes of eight other medically important bacteria. NIAID also supports projects to provide complete or partial genome sequences of large parasitic protozoa.
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Maintaining A Research Base
The burden of infectious and immunologic diseases, in human and economic terms, is enormous. It is critical that we maintain a strong scientific infrastructure in core disciplines such as infectious diseases, immunology and microbiology to meet the challenges of these diseases. With skillful use of the increasingly powerful tools of molecular biology, by identifying research opportunities and priorities and vigorously pursuing them, and by sustaining a strong research base, we will be well-positioned to make further progress against current disease threats as well as the new diseases that will inevitably emerge.
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Posters Accompanying Dr. Fauci's Testimony
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