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Testimony on Global Health: the United States Reponse to Infectious Diseases by Anthony Fauci, M.D.
Director, National Institute of Allergy and Infectious Diseases
National Institutes of Health
U.S. Department of Health and Human Services

Before the Senate Committee on Labor and Human Resources, Subcommittee on Public Health and Safety
March 3, 1998

Senator Frist and members of the Subcommittee, I am pleased to appear before you today to discuss the role of the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institutes of Health (NIH) in developing better means of preventing, diagnosing and treating infectious diseases, and the importance of basic and clinical research to our preparedness for emerging and re-emerging infections.

As you know, in this century vaccines, drugs, improved sanitation and control of disease-transmitting insects have made enormous contributions to the public health. Smallpox has been eradicated. Polio has been eliminated from the western hemisphere, and the goal of worldwide polio eradication is within our grasp. Diseases such as rubella, measles, cholera, typhoid fever and diphtheria, once major killers in this country, are now rare.

The burden of infectious diseases

Despite significant progress, infectious diseases remain the world's leading cause of death, and the third leading cause of death in the United States. In 1996 alone, an estimated 3 million deaths worldwide were attributed to tuberculosis (TB), 2.5 million to diarrheal diseases, 1.5 to 3.0 million to malaria (including one million children under age five), and 1.2 million to chronic hepatitis B virus infection. In addition to their human toll, the financial and psychological burdens of infectious diseases on families and communities are enormous.

Drug resistance: a growing problem

Many serious infections are becoming increasingly resistant to standard antibiotics, making treatment difficult and in some cases impossible. For example, drug-resistant tuberculosis has now been found in virtually every country surveyed. Worldwide, more than ten percent of TB cases are resistant to one or more of the four first-line anti-TB drugs. In the United States, more than one-third of hospital-acquired infections with Staphylococcus aureus are resistant to penicillin-like drugs, leaving vancomycin as the only available drug that reliably eradicates them. We were given pause in recent months when S. aureus isolates with increased resistance to vancomycin were identified for the first time in Japan and the United States. Many other diseases, including enterococcal infections and pneumococcal pneumonia, are increasingly problematic because of the development of drug resistance.

Emerging and re-emerging diseases

Superimposed on these concerns are more than three dozen diseases and syndromes newly recognized since the mid-1970s. This list, which includes AIDS; liver disease due to hepatitis C virus; a new form of cholera; tick-transmitted Lyme disease and ehrlichiosis; foodborne illness caused by E. coli 0157:H7 and Cyclospora; waterborne disease due to Cryptosporidium; and the hantavirus pulmonary syndrome, continues to grow. For example, in 1997 the first known cases of human influenza caused by a virulent bird virus known as H5N1 avian influenza were identified in Hong Kong.

The link between microbes and chronic diseases

In recent years, it also has become clear that many cancers and other chronic conditions can be attributed to infectious diseases. For example, both hepatitis B virus and hepatitis C virus can lead to liver cancer, and human papilloma virus is responsible for most cases of cervical cancer. Chlamydia pneumoniae has been implicated as a cause of atherosclerosis, and we now know that the bacterium Helicobacter pylori causes ulcers and stomach cancer. In addition, certain autoimmune diseases, including Reiter's syndrome, are linked to infectious microbes.

The importance of research

Clearly, we remain vulnerable to infectious diseases, old and new. We face a difficult challenge: coping with ongoing problems, and preparing for the inevitable emergence of diseases that are currently unknown or under control. In this regard, the early detection and tracking of pathogens, a function primarily of the Centers for Disease Control and Prevention (CDC), is critical. Equally important is the basic and clinical research conducted by NIH and our sister agencies. Historically, basic research has led to important, often unpredictable, advances that have illuminated the etiology of sometimes mysterious diseases and facilitated the development of diagnostics, therapies and vaccines.

Basic research and HIV/AIDS

Rapid advances in HIV/AIDS research have been possible because of the foundation in basic science developed over the past decades. In the 1960s and 1970s, before the identification of HIV as the cause of AIDS, a number of top cancer researchers were working on viruses known as RNA tumor viruses. Among this group were two investigators who discovered the reverse transcriptase enzyme, an accomplishment for which they later won the Nobel Prize. This discovery facilitated the identification in 1983 of HIV, which also contains reverse transcriptase. Without basic research, we might still be wondering what caused the AIDS epidemic.

More recently, fundamental research into the structure and function of the HIV protease enzyme led to the development of a powerful new class of anti-HIV medications that block this enzyme and hence the replication of the virus. Protease inhibitors are now widely prescribed as part of combination treatment regimes for HIV-infected people, and have helped dramatically reduce the number of deaths due to HIV in this country.

The development of diagnostic tools also is closely linked to basic research, and critically important in this era of economic constraint and emphasis on cost-effective technologies. Thanks largely to research by virologists at the NIH, we have had a useful diagnostic kit for HIV since 1985. The development of a technology called the polymerase chain reaction, based on fundamental research into the bacterium Thermus acquaticus, has led to sensitive and non-invasive diagnostic tools for many diseases, including chlamydia and other sexually transmitted diseases. These tests can help clinicians detect and treat asymptomatic infections before they cause serious health problems.

A rapid response to avian H5N1 influenza

As mentioned above, an outbreak of an avian influenza in people in Hong Kong recently alarmed the medical community. Fortuitously, as part of NIAID's long-standing research into respiratory viruses, we had in our reagent repository the specific antisera needed to quickly develop test kits for detecting the avian influenza virus. We also have supported the rapid production of a recombinant vaccine against the avian influenza virus for use in at-risk laboratory and health care personnel. Thus, building on years of research, we were able to move quickly in concert with our colleagues at the CDC, the World Health Organization (WHO) and other agencies to address the critical public health needs associated with the outbreak.

New initiatives in NIAID's 50th year

This year, as the NIAID prepares to celebrate our 50th anniversary, we have enhanced our efforts in finding new tools for the diagnosis, treatment, prevention and control of infectious diseases, especially emerging diseases and those with potential for re-emergence. For instance, the Institute is developing research and training programs to build a critical mass of scientists with expertise in diseases of importance to global health. NIAID also supports numerous studies -- domestically and internationally -- on topics related to disease emergence, such as the molecular basis of drug resistance and the mechanisms of pathogen virulence. The Institute sponsors five international programs in tropical infectious diseases, most of which have components both in the United States and at institutions in developing countries.

Defining priorities

With the help of our advisory panels, we have defined infectious disease priorities in three broad areas:

  • Expanding basic and applied research to advance our understanding of infectious agents, our susceptibility and immune responses to them, and the environmental factors that influence their emergence and spread.

  • Strengthening our ability to develop and validate new tools, including therapies, diagnostics, and vaccines, to prevent and control infectious diseases.

  • Ensuring that support for training and research is sufficient for building and maintaining the scientific expertise and resources needed to control emerging infectious diseases.
Malaria research

An important focus of these efforts is research into malaria, a disease of enormous importance, particularly to the 40 percent of the world's population living in malaria-endemic regions. The WHO estimates that 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, we have worked with research organizations and donor agencies from around the world to form a coalition called the Multilateral Initiative on Malaria to enhance international collaborations, encourage the involvement in malaria research of scientists from malaria-endemic countries, and identify additional malaria research resources.

In addition, we have bolstered 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.

Hepatitis C

Another priority of the NIH is research into the hepatitis C virus (HCV), 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, NIH 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 critical to the development of effective therapies and a vaccine.

The importance of vaccines

With malaria, hepatitis C and many other diseases, an important goal of the NIH is the development of vaccines. The impact and importance of vaccines cannot be overstated -- these powerful public health tools provide safe, cost effective and efficient means of preventing illness, disability and death from infectious diseases. Perhaps the greatest triumph of public health -- the global eradication of smallpox -- resulted from widespread immunization programs with an inexpensive, effective, easily administered vaccine.

Basic research drives vaccine development

Historically, scientific advances in microbiology and related disciplines have led to the development of new vaccines. For example, the identification of microbial toxins, as well as methods to inactivate them, allowed the development of some of our earliest vaccines, including those for diphtheria and tetanus. In the 1950s, new tissue culture techniques ushered in a new generation of vaccines, including those for measles, mumps and rubella. In recent years we have seen rapid advances in our understanding of the immune system and the complex interactions between pathogens and the human host, as well as extraordinary technical advances such as recombinant DNA technology, gene sequencing and peptide synthesis. These developments have created opportunities for improving the safety and efficacy of existing vaccines as well as for developing vaccines for diseases for which no vaccines are currently available.

Vaccines: recent successes

Widespread use of vaccines based on technology developed by NIH-supported researchers has resulted in the virtual elimination of meningitis caused by Haemophilus influenza type B (Hib) wherever the vaccine has been used. Prior to the availability of an effective Hib vaccine, at least 10,000 U.S. infants suffered invasive Hib disease annually, 10 percent of whom died and 20 to 30 percent of whom were left with long-term neurologic sequelae. Today, Hib meningitis is virtually unknown in the United States, and the Hib vaccine saves $400 million for each cohort of children vaccinated. Building on the precedent set with vaccines against smallpox and polio, widespread use of the Hib vaccine could one day eradicate Hib meningitis in this country.

We now have a safe and effective hepatitis A vaccine developed by NIH researchers, which has reduced the burden of this food- and water-borne disease. Another vaccine developed by NIH scientists has proven safe and effective in preventing the severe diarrheal illnesses caused by rotavirus, which kill over 870,00 children worldwide every year. The successful development of these vaccines exemplifies the synergy between basic and applied research, as well as the fruitful collaborations that are possible between the private and public sectors.

HIV vaccine development

Although recent treatment advances have led to an encouraging downturn in the number of new AIDS cases and AIDS-related deaths in this country, the epidemic continues to accelerate elsewhere in the world. In 1997 alone, approximately 5.8 million people globally were newly infected with HIV, including approximately 590,000 children under age 15. More than 90 percent of these new infections -- approximately 16,000 each day -- occurred in developing countries. By the end of 1997, an estimated 30.6 million people were living with HIV/AIDS, a figure projected to reach 40 million by the year 2000. These trends underscore the importance of vigorously pursuing HIV vaccine research and other prevention efforts to slow the spread of the epidemic, in addition to finding new and better ways to treat those already infected with HIV.

Last year, the participants in the Denver Summit of Eight stressed their shared commitment to developing an HIV vaccine. President Clinton, through the President's Vaccine Initiative, has made HIV vaccine development a top priority, with the goal of having a useful HIV vaccine within ten years. At NIH, we have increased our support for a range of basic, preclinical and clinical research activities to improve upon the vaccine candidates that were the first to reach clinical trials. As part of our expanded effort in HIV vaccine research, we recently awarded 58 grants to foster innovative research on HIV vaccines. In addition, the NIH has begun development of a Vaccine Research Center (VRC) within the intramural research program, co-sponsored by NIAID and the National Cancer Institute, to stimulate multidisciplinary research into basic and clinical immunology and virology, and ultimately vaccine design and production. Concomitant with efforts in HIV vaccine development, the NIH and our sister agencies within DHHS have taken a leadership role in developing other approaches to HIV prevention, such as behavioral modification, the development of topical microbicides that women can use to protect themselves from HIV and other infections, and new ways to prevent maternal-fetal transmission. Such interventions promise to have an important impact in fighting HIV in both the developed and developing world.

Toward a tuberculosis vaccine

As noted above, TB exacts an enormous toll worldwide. Resistance to TB drugs is widespread; even when effective, four of these drugs generally must be taken for at least six months in order to cure the disease, often in the setting of directly observed therapy. Clearly, an effective TB vaccine is needed. NIH is working to develop a TB vaccine with a two-tiered approach: basic research into the mechanisms of the disease and the response of the immune system to the infection; and applied research into developing vaccine candidates. Several candidates appear promising in pre-clinical studies, including live-but-weakened strains of the TB bacterium, vaccines based on components of the organism, and so-called "naked DNA vaccines"

Improving current vaccines

Substantial NIH resources are also devoted to developing improved vaccines that are more effective or easier to administer than current vaccines while having fewer side effects. The prototype of this kind of research is the NIH program to develop acellular pertussis vaccines. In two seminal NIH-sponsored trials in Italy and Sweden, researchers conclusively demonstrated that acellular pertussis vaccines were highly effective in protecting infants against whooping cough, with fewer side-effects than a whole-cell pertussis vaccine that had been in use for many years. The positive results of these trials, the culmination of more than 15 years of NIH efforts in the development of acellular pertussis vaccines, have helped define acellular vaccines as the new "gold standard" in pertussis immunization. We anticipate that the availability of acellular pertussis vaccines will break down a significant barrier to pertussis immunization --the reactogenicity of the whole cell vaccine by improving vaccine coverage and thereby reducing pertussis-related disease and death.

In the past few months, researchers in NIAID's Vaccine and Treatment Evaluation Units have reported promising results with a new influenza vaccine, given as a nasal spray. The new vaccine promises to be easier to administer and more acceptable than injections, thereby increasing vaccine coverage. The nasal flu vaccine has proven safe and effective in children; large-scale trials, now underway, will determine whether it protects older people most at risk of serious influenza disease and if, as hoped, it reduces influenza-related health care costs and absenteeism in adults.

Developing research infrastructure

As we proceed with our efforts to conduct research on infectious diseases with global impact, it is essential to engage scientists in other countries and work collaboratively. Particularly in developing countries where the burden of infectious diseases has extraordinary impact, the development of research infrastructure is an important component of our efforts. To address this need, the Fogarty International Center and the NIAID collaborate to carry out training and research programs intended to enhance the skills of developing country scientists and foster collaborations with our foreign partners.

The promise of new technologies

We now have at our disposal remarkably fast and accurate methods for sequencing the genomes of disease-causing microbes, tools that are a boon to vaccine development, studies of drug resistance, and many other areas of research. The success of the first microbe sequencing project -- the delineation of the complete Haemophilus influenzae genome in 1995 -- encouraged our current efforts to sequence the full genomes of several other medically important pathogens.

Other technologies of great importance to our mission fall outside the disciplines traditionally associated with infectious disease research. For example, in partnership with the National Aeronautics and Space Administration, NIH-funded scientists are using satellite-based remote sensing technology and geographic information systems to identify ecologic conditions associated with infectious disease outbreaks. This approach could help predict potential disease outbreaks and identify regions where intervention programs should be targeted.


Using modern technologies, NIH continues to build a solid research foundation in immunology, microbiology and related disciplines that drive the development of new treatments, vaccines and diagnostic tools for infectious diseases.

With a strong research infrastructure in these areas, our ability to do battle with infectious microbes -- known and unknown -- is greatly enhanced.

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