Good morning. I am Dr. David Satcher, Assistant Secretary for Health, Department of Health
and Human Services and Surgeon General. I want to thank you, Mr. Chairman and members of
the Subcommittee, for your invitation to testify at this important hearing on "Antimicrobial
Resistance: Solutions to a Growing Public Health Problem." I will briefly address issues related
to resistance, discuss the associated public health problems, and describe the targeted public
health messages for the public and medical community. In addition, you have asked me to
describe the President's FY 2000 budget for public health initiatives, which I will highlight at the
end of my statement.
Emerging infectious diseases are a continuing threat to the health of U.S. citizens and people
around the world. They cause suffering and death and impose an enormous financial burden on
society. Antimicrobial drugs have saved the lives of millions of people. However, the
emergence of drug resistance in bacteria, parasites, viruses, and fungi is threatening to reverse
medical progress of the past 50 years.
Background
Tremendous strides have been made in medicine and science to combat infectious diseases. The
development and widespread use of antibiotics and vaccines, coupled with earlier improvements
in urban sanitation and water quality, have dramatically lowered death and disability from
infectious diseases. Progress had been so great that three decades ago some experts predicted we
would soon see the end of infectious diseases as a significant problem.
However, our optimism, though understandable, was premature. Today, we see a global
resurgence of infectious diseases, including the identification of new infectious agents, the
reemergence of old infectious diseases such as tuberculosis and the rapid spread of antimicrobial
resistance. As we approach the 21st century, many important drug choices for the treatment of
common infections are becoming increasingly limited and expensive and, in some cases, non-existent.
In 1995, I had the honor of chairing a working group on emerging infectious diseases for a
Committee of the National Science and Technology Council (NSTC), which was charged with
conducting a government-wide review of our ability to protect our citizens from emerging
infectious diseases. The NSTC Committee -- the Committee on International Science,
Engineering and Technology (CISET) -- was staffed by the Department of State. The issue of
emerging infectious diseases was regarded as urgent by many U.S. agencies, and more than 20
agencies ultimately participated in the working group.
In September 1995, the Committee issued a report which concluded that existing mechanisms for
surveillance, response to, and prevention of outbreaks of new and reemerging infectious diseases
were inadequate, both at home and abroad. The report described the seriousness of infectious
diseases and problems of antimicrobial resistance in the United States
and made specific
recommendations that became the basis of a 1996 Presidential Decision Directive (PDD) that
established a new national policy. The Directive called for a coordinated U.S. government
response to address the growing health threats posed by infectious diseases including those
caused by pathogens that are resistant to antimicrobial drugs.
The PDD calls for the establishment of an Emerging Infectious Diseases (EID) Task Force,
which I co-chaired with Dr. Kerri-Ann Jones, the former Associate Director for National Security
and International Affairs of the White House Office of Science and Technology Policy (OSTP).
The President charged the EID Task Force with implementing the PDD. The lead agencies on
the Task Force include three agencies within the Department of Health and Human Services
(DHHS): the Centers for Disease Control and Prevention (CDC), the Food and Drug
Administration (FDA) and the National Institutes of Health (NIH); as well as the U.S. Agency
for International Development (USAID) and the Department of Defense (DOD). The U.S.
Department of Agriculture (USDA) has also played an increasingly important role. In addition
to OSTP, the Department of State, the National Oceanic and Atmospheric Administration
(NOAA) of the Department of Commerce, the National Aeronautics and Space Administration
(NASA), and the Department of Veterans Affairs are also active participants. In working toward
the goals of the Task Force, USAID, CDC, and other agencies are also supporting the efforts of
the World Health Organization to improve communications networks and build regional centers
for surveillance of and response to infectious diseases.
Agency Collaboration
From the beginning, the basic principles of the EID Task Force and the work group on emerging
diseases have been collaboration and coordination. We know that the challenge ahead outstrips
the means available to any one agency or organization, and various DHHS agencies' missions are
relvant to the issues of antimicrobial resistance.
CDC addresses antimicrobial resistance as a major focus area in its plan, Preventing Emerging
Infectious Diseases: A Strategy for the 21st Century. CDC's programs include activities that
focus on working with other Federal agencies, State and local health departments, academic
centers, health care providers and networks, international organizations, and other partners to
conduct surveillance and identify infectious disease problems. CDC combines its strengths in
epidemiology and laboratory sciences to solve problems that cannot be solved by either
discipline alone, such as developing new laboratory tests to improve the timeliness and accuracy
of detecting antimicrobial resistance and developing and disseminating practical
recommendations and guidelines for the prudent use of antimicrobial drugs.
The National Institutes of Health funds a diverse portfolio of grants and contracts to study
antimicrobial resistance in major viral, bacterial, fungal, and parasitic pathogens. This support
includes investigator-initiated and solicited research on microbial pathogenesis and host-pathogen interactions, molecular mechanisms responsible for drug resistance, as well as research
to develop and evaluate new or improved products for disease diagnosis, intervention, and
prevention. Numerous genome projects seek to identify new gene targets for the development of
drugs and vaccines. Pathogens that have developed resistance and are being studied include:
HIV and other viruses; nosocomial bacteria such as staphylococci, enterococci, and E. coli;
bacteria that cause respiratory diseases such as pneumonia and tuberculosis; foodborne bacteria
such as Salmonella and Campylobacter; organisms that cause sexually transmitted diseases;
Candida and other fungi; and parasites of international importance such as Plasmodium
falciparum, a cause of malaria.
Other NIH sponsored activities with relevance to antimicrobial resistance include physician and
research training and education and the conduct of workshops and symposia. The National
Institute of Allergy and Infectious Disease has a lead role in many of the resistance-related
activities but numerous other agencies also support and participate in these activities. Expanded
research on microbial changes influencing disease emergence, such as the evolution of drug
resistance, was a major emphasis of the 1996 Research Agenda for Emerging Infectious Diseases
of the National Institute of Allergy and Infectious Diseases.
The FDA also has a critical role in addressing the growing public health problem of
antimicrobial resistance and has been working with CDC, NIH, and industry to help meet this
threat. FDA is committed to the development and approval of new drugs and vaccines to treat or
prevent antimicrobial resistant infections and to the appropriate labeling, promotion, and use of
approved antimicrobials for both humans and food animals in order to protect the safety and
efficacy of these antimicrobials and the public's health. Examples of recent or ongoing FDA
activities include devising plans to include information on antibiotic resistance and prudent use
of antimicrobials in product labeling and exploring other options for encouraging appropriate use
of antimicrobials, such as working with industry to include messages about appropriate antibiotic
use in their consumer advertising campaigns.
There is growing scientific evidence that certain uses of antimicrobials in food-producing
animals can lead to antibiotic resistance in intestinal bacteria that are then transmitted to people,
causing treatment-resistant illness. Recent FDA actions in response to these concerns include
proposing a new framework for antimicrobial drug use in food-producing animals in order to
protect human health and prolong the period of usefulness of antimicrobials; working with the
American Veterinary Medicine Association to develop and implement educational programs for
the judicious veterinary use of prescription antimicrobials; implementing and interagency
coordination of the National Antimicrobial Resistance Monitoring System for Enteric Bacteria,
(NARMS:EB), to monitor antimicrobial resistance in man and other animals for specific
pathogens that are predominantly acquired from food-producing animals; and research to
understand the mechanisms of resistance development in food-producing animals in order to
better address human health concerns.
Overview of Antimicrobial Resistance
Drug resistance is a serious clinical and public health problem in the United States
and globally.
Although we have been using antibiotics for more than 50 years, the extent of resistance is much
greater than ever before, and the number of new drugs in the late stages of testing is limited. In
past years serious problems of drug resistance tended to involve a small number of pathogens,
and new drugs were continually being developed and replacing drugs that were no longer
effective because of resistance. But today, the frequency of drug resistance is increasing in
virtually all hospital- and community-acquired pathogens. In part, this is because resistance is a
consequence of the selective pressure exerted by widespread antimicrobial drug use.
Antimicrobial drugs kill the sensitive pathogens, but the resistant ones survive, and with time the
resistant ones become predominant. Antimicrobial drugs have been used extensively and often
inappropriately, with little concern about resistance as an adverse effect. We now face the
consequences.
The Public Health Problem
In a report released last year, "Antimicrobial Resistance: Issues and Options Workshop Report"
from its Forum on Emerging Infections, the Institute of Medicine (IOM) noted that while the
phenomenon of antimicrobial resistance is neither surprising nor new, it is newly worrying
because the problem is spreading rapidly. In some areas of the United States
, up to 30 percent of
infections with Streptococcus pneumoniae, the most common cause of bacterial pneumonia,
meningitis, and ear infections, are no longer susceptible to penicillin. Many of these infections
are resistant to other common antibiotics as well. For some pathogens, we have reached the
point where there are virtually no available drugs left to treat them, such as vancomycin-resistant
enterococci acquired by patients in U.S. hospitals.
Data from intensive care unit patients in the United States
indicate that more than 25 percent of
the bacteria that most frequently cause hospital-acquired infections are resistant to the preferred
antibiotic for treatment. One organism of particular concern is Staphylococcus aureus, the most
common cause of hospital-acquired infections. Approximately 35 percent of S. aureus infections
acquired in United States
hospitals are resistant to the drug methicillin, and the rate of resistance
to this drug has risen 15 fold in the last 20 years. Serious infections caused by resistant S. aureus
frequently require treatment with vancomycin, which is the last uniformly effective available
drug against S. aureus, and some strains of S. aureus with diminished susceptibility to
vancomycin have been identified recently.
The ramifications of antimicrobial resistance are becoming more serious for a wider range of
diseases. Resistance has become a serious problem for pathogens that cause tuberculosis, AIDS,
salmonellosis, gonorrhea, malaria, and other common infections. Individuals infected with
resistant pathogens may experience more and longer hospital stays due to resistance, and
mortality rates are estimated to be more than twice as high for these patients than those with
antimicrobial-susceptible infections.
Economic Costs of Drug Resistance
A recent study conducted in New York City by the Lewin Group estimated that resistant
infections due to Staphylococcus aureus cost an additional $2500 per infected patient, or $7
million annually in New York City alone. A 1995 Office of Technology Assessment (OTA)
report, "Impacts of Antibiotic-Resistant Bacteria," estimated that the emergence of antimicrobial
resistance among six common bacteria in hospitals adds approximately $661 million per year in
hospital charges. This estimate does not include indirect costs or costs of infections caused by
other resistant pathogens. OTA also noted that as the spread of resistance continues, these costs
can be expected to increase. This points to great potential for economic savings from preventing
resistance and the resulting infections.
Public Health Messages
As is the case with most public health issues, effective prevention programs will require strong
linkages between public health practitioners and those involved in clinical practice. One
approach to preventing the spread of drug resistance is developing and disseminating practical
public health messages to the medical community and the public regarding the scope of the
problem and the prudent use of antimicrobial drugs. CDC estimates that more than 100 million
courses of antibiotics are provided by office-based physicians each year. Based on preliminary
analysis, many of those are unnecessary, being prescribed for colds, coughs, and other viral
infections such as influenza against which antibiotics are not effective. Prudent use of antibiotics
is the key to decreasing, or even reversing, the spread of resistance. Although the solution to the
problem of antibiotic resistance is complex, we do know that when communities have decreased
antibiotic use, they also have decreased resistance.
One important tool in decreasing antibiotic use is assuring that people at greatest risk of
influenza and pneumonia, including the elderly and those with chronic illnesses, are vaccinated
against those diseases. Unfortunately, many of these at-risk adults do not receive an annual
influenza vaccine, and most adults at risk for pneumonia have not received pneumococcal
vaccine. If they did, it could not only prevent serious illness and save lives, but also greatly
reduce the use of antibiotics otherwise needed to treat pneumonia.
Physicians should prescribe antimicrobial drugs only when they will be beneficial and, when
possible, prescribe drugs that are specific for the bacteria causing the infection. The public needs
to be aware that antimicrobial drugs offer no benefit for colds, the flu, most sore throats, and
other illnesses caused by viruses. If a patient takes an antibiotic when it is not necessary, such as
for a cold, there is an increased risk of developing an infection caused by antibiotic-resistant
bacteria. Infections caused by resistant bacteria may be difficult or impossible to cure with
antibiotics and could even spread to others. Patients should avoid requesting their doctors to
prescribe antibiotics; however, when an antibiotic is prescribed, it should be taken exactly as
directed. The public should be made aware of the appropriate use for antibiotics so that
infections remain treatable and antimicrobial drugs remain effective for as long as possible.
Preventing and controlling antimicrobial resistance is not just a problem for doctors and
scientists; we all must do our part.
Additionally, the pharmaceutical industry has an important role to play in developing new drugs
that will treat strains of bacteria that have become resistant to conventional antibiotics.
Pharmaceutical companies have an important educational opportunity to include messages about
antibiotic resistance and to discourage unneeded or inappropriate use of their products.
Global Implications
In order to be successful, efforts to address antimicrobial resistance must be undertaken on a
global scale, since resistant organisms can spread quickly in our global village. Drug resistance
is an emerging problem throughout the world--not only for the infections that are common in the
United States
and other developed countries, but also for others such as malaria and typhoid
fever that are becoming increasingly difficult to treat in many countries due to drug resistance.
CDC is working with the US Agency for International Development, the World Health
Organization, the Pan American Health Organization, the European Union, and many other
partners to improve global coordination, offer technical assistance, training, and assist in
developing surveillance and prevention and control measures internationally.
Tuberculosis provides a striking example. In this decade, we have had to aggressively combat a
resurgence of TB in the United States
. We have made extraordinary progress, with the number
of cases declining dramatically.
New York City was among the hardest hit by the resurgence of TB. Although cases are down in
New York City, in 1997, a majority of new TB cases were found among the city's foreign born
population - among people who were exposed elsewhere, emphasizing the need to work globally
to sustain further declines in U.S. TB cases.
Overview of the FY 2000 Budget Request for Public Health Initiatives
When I was invited to appear before the Subcommittee today, I was asked to provide an
overview of the President's fiscal year 2000 budget with respect to federal initiatives to improve
our public health infrastructure. The following overview highlights several of our most
important activities.
As we enter the 21st century, new threats to our public health are continually emerging. From the
challenge of confronting infectious diseases, to the possibility of a bioterrorist attack and the
ongoing problems of foodborne illness, we must constantly be vigilant. The only way to
successfully combat the public health problems of tomorrow is by investing today in the
necessary medical research and public health and disaster response infrastructure.
International trade, commerce, and tourism have truly created a global village. Because
infectious diseases do not recognize borders, it is increasingly necessary to protect the health and
safety of American citizens by investing in a global public health strategy.
Working in partnership with the WHO, and providing the necessary resources, we can develop
the global strategy that is critical to protecting our citizens and people around the world.
Terrorism represents a serious threat to the peace and prosperity of our nation. While terrorist
attacks can take numerous forms, the threat posed by bioterrorism is particularly deadly, because
it can affect a large population, remain undetected for some time, and cause secondary illness or
death if the agent is communicable. As the lead federal agency responsible for preparing for and
responding to the medical and public health consequences of a bioterrorist event, we are
mounting a comprehensive public health effort to combat this deadly threat.
The President's Budget includes $230 million for the Department to undertake a coordinated,
four-pronged initiative to prepare for the medical needs and health consequences resulting from a
potential terrorist use of biological weapons. First, our budget invests in the infectious disease
surveillance infrastructure needed to detect the occurrence of a bioterrorist attack and to
determine its cause, including improvements in case reporting, epidemiological and laboratory
capacity, and the development of information technology to allow coordination among Federal,
State and local public health officials. Second, it funds the purchase of a stockpile of the
vaccines needed to treat the most likely biological agents. Third, the budget invests in
developing the medical response capability at the local level to respond to an outbreak by
training local health providers and supporting the creation of 25 Metropolitan Medical Response
Systems. Finally, it provides funds for research and development activities to develop and
expedite review of new vaccines and therapeutics and new rapid screens for diagnosing chemical
agents.
Our nation needs a high quality surveillance system to collect and analyze epidemiologic
information if we are to be able to respond effectively to a future outbreak of disease. The
President's budget proposes to strengthen our surveillance system by providing a total of
$65 million to support the implementation of a National Electronic Disease Surveillance
Network Initiative (NEDSNI) at the Centers for Disease Control and Prevention. This Initiative
would integrate electronic communications related to surveillance for the Emerging Infectious
Diseases ($15 million), Bioterrorism ($40 million), and Food Safety ($10 million) programs and
will establish communication links with the public health and medical communities to enable
them to furnish timely information on outbreaks of communicable diseases to State and local
public health departments and assure better communications among public health entities. It will
also help address problems such as the emergence of drug resistance.
Surveillance is just one of the keys to fighting outbreaks of foodborne illness. Food-related
hazards are responsible for as many as 33 million illnesses and up to 9,000 deaths each year. To
combat these outbreaks, the budget seeks $29.5 million for the CDC, a $10 million increase, to
expand the PulseNet network of health labs which perform DNA "fingerprinting" of disease
causing bacteria. In addition, FDA is seeking $188 million to support its food safety efforts.
Biomedical research has been the foundation of the unprecedented gains we have made in
improving the health of both Americans and the world. Last year, the President made a
commitment to increase the budget for the National Institutes of Health, the world's largest and
most distinguished organization for biomedical research, by nearly 50 percent over five years,
and Congress responded by passing an increase of almost $2 billion. This year's budget
continues the President's commitment and keeps us on the path set last year with an investment
of $15.9 billion, an increase of $320 million. The FY 2000 request, combined with last year's 14
percent increase, represents a 17 percent increase over two years. This year's request will enable
NIH to fund over 30,000 research projects grants, the highest total in history.
Along with his commitment to increase funding for biomedical research, the President last year
also made a commitment to ensuring that scientific advances are translated into better health care
for the American people. The President's budget honors this commitment as well, providing an
increase of $35 million for the Agency for Health Care Policy and Research. These funds will be
spent on health care research that will enhance knowledge about how to improve outcomes and
quality of medical treatment and how to best translate research results into daily practice to
improve health care for all Americans.
Conclusions
While issues of antimicrobial resistance are multifaceted, complex, and serious, much work is
being done by the various agencies of the Public Health Service to develop and implement
prevention initiatives to address the problem. There is much more to accomplish. Combating
resistance requires that antimicrobial drugs are used only when necessary, that new drugs and
vaccines are developed, and that infection control measures are used appropriately in hospitals,
day care centers, and long-term care facilities. Combating resistance will also require Federal
leadership, outreach and partnerships in the public and private sectors, both domestically and
internationally, and collaboration between public health and medical care sectors.
The rapid spread of resistance demands an aggressive response, and the challenges ahead demand
our continued attention. By collaboratively addressing the issues, we can prolong the
effectiveness of currently available drugs and reduce the threat of resistance for patients today
and in future generations. Our goal is to ensure that we are able to protect ourselves and the
global community from emerging pathogens and emerging resistance to antimicrobial drugs
whenever and wherever they may arise.
Thank you for the opportunity to testify before the Subcommittee. I will be happy to answer any
questions you may have.
