ISSUE REPORT

Germs Go Global:
WHY EMERGING INFECTIOUS
DISEASES ARE A THREAT TO AMERICA

OCTOBER 2008

PREVENTING EPIDEMICS.
PROTECTING PEOPLE.
Trust for America’s Health is TFAH BOARD OF DIRECTORS Kimberly Elliott, MA
a non-profit, non-partisan Deputy Director
organization dedicated Lowell Weicker, Jr. Trust for America’s Health
to saving lives and making President
Former 3-term U.S. Senator and Governor Lynora Williams, MA
disease prevention a
of Connecticut Consultant, and
national priority.
Principal, Lyric Editorial Services
This issue brief is supported Cynthia M. Harris, PhD, DABT
by a grant from the de Vice President CONTRIBUTORS
Beaumont Foundation. Director and Associate Professor
Institute of Public Health, Florida A & M Laura Segal, MA
The opinions expressed are University Director of Public Affairs
those of the authors and do Trust for America’s Health
not necessarily reflect the Margaret A. Hamburg, MD
Secretary Serena Vinter, MHS
views of the Foundation. Senior Research Associate
Senior Scientist
TFAH wishes to express Nuclear Threat Initiative (NTI) Trust for America’s Health
special appreciation to the
U.S. Centers for Disease Patricia Baumann, MS, JD PEER REVIEWERS
Control and Prevention and Treasurer TFAH thanks the reviewers for their time, expertise,
to the National Institute of President and CEO and insights. The opinions expressed in this report do
Allergy and Infectious Bauman Foundation not necessarily represent the views of these individuals
Diseases for expert review Gail Christopher, DN or the organizations with which they are affiliated.
and helpful suggestions. Vice President for Health Edward A. Belongia, MD
WK Kellogg Foundation Director, Epidemiology Research Center
John W. Everets Marshfield Clinic Research Foundation

David Fleming, MD Luciana L. Borio, MD

Director of Public Health Senior Associate
Seattle King County, Washington Center for Biosecurity
University of Pittsburgh Medical Center
Arthur Garson, Jr., MD, MPH
Executive Vice President and Provost and the Robert J. Guidos, JD
Robert C. Taylor Professor of Health Science and Director, Public Policy & Government Relations
Public Policy Infectious Diseases Society of America
University of Virginia James Hughes, MD
Robert T. Harris, MD Professor of Medicine and Public Health
Former Chief Medical Officer and Senior Vice School of Medicine; Rollins School of
President for Healthcare Public Health; Emory University, and
BlueCross BlueShield of North Carolina Former Director
National Centers of Infectious Diseases; U.S.
Alonzo Plough, MA, MPH, PhD Centers for Disease Control and Prevention
Vice President of Program, Planning and Evaluation
The California Endowment Kathleen F. Gensheimer, MD, MPH
State Epidemiologist
Theodore Spencer Maine Department of Health and
Project Manager Human Services
National Resources Defense Council
James Lawler, MD, MPH, FACP
REPORT AUTHORS CDR MC U.S. Navy; Chief Medical Officer
Integrated Research Facility at Fort Detrick
Margaret A. Hamburg, MD Division of Clinical Research, National
Senior Scientist Institute of Allergy and Infectious Diseases;
Nuclear Threat Initiative (NTI) National Institutes of Health
Jeffrey Levi, PhD Ruth Lynfield, MD
Executive Director State Epidemiologist
Trust for America’s Health, and Minnesota Department of Health
Associate Professor in the Department of Health Policy
The George Washington University School Michael Mair, MPH
of Public Health and Health Services Associate
Center for Biosecurity
University of Pittsburgh Medical Center
Germs Go Global:
WHY EMERGING INFECTIOUS
DISEASES ARE A THREAT TO AMERICA
An Issue Brief from Trust for America’s Health
Funded by a Grant from the de Beaumont Foundation

“ THE HEALTH OF U.S. CITIZENS IS INEXTRICABLY LINKED TO THE HEALTH OF

OTHER PEOPLE IN OTHER PARTS OF THE WORLD: MICROORGANISMS CAN AND DO

CROSS BORDERS EASILY AND OFTEN WITHOUT RECOGNITION.

”
1

-- SCIENCE

OVERVIEW
Despite remarkable breakthroughs in medical impact Americans, with far-reaching conse-
research and advancements in immunization quences for the U.S. public health system, the
and treatments during the 20th century, delivery of medical care, and the economy.
infectious diseases are undergoing a global According to a National Intelligence Estimate,
resurgence that threaten everyone’s health. “newly emerging and re-emerging infectious
diseases, many of which are likely to continue
Worldwide, infectious diseases are the leading
to originate overseas, will continue to kill at
killer of children and adolescents, and are
least 170,000 Americans annually. Many more
one of the leading causes of death for adults.
could perish during a severe influenza pan-
The range of infectious threats includes:
demic or yet-unknown disease.”2
I The emergence of new infectious diseases,
Intelligence analysts argue that “newly
severe acute respiratory syndrome (SARS)
emerging and re-emerging infectious dis-
and the H5N1 avian influenza virus;
eases will pose a rising global health threat
I The resurgence of known infectious dis- and will complicate U.S. and global security
eases, such as measles and pertussis over the next 20 years. These diseases will
(whooping cough); endanger U.S. citizens at home and abroad,
threaten U.S. armed forces deployed over-
I The persistence and spread of certain
seas, and exacerbate social and political
“neglected” infectious diseases, like
instability in key countries and regions in
dengue fever;
which the U.S. has significant interests.”3
I The potential deliberate use of deadly
Federal support for identifying, preventing,
bioterrorism agents, such as smallpox
containing, and treating emerging infectious
virus or anthrax; and
diseases varies widely. The U.S. government has
I The growing rise and spread of antimicro- invested significantly in the pursuit of drugs
bial resistance has led to the development and vaccines that could counter an intentional
of resistant pathogens and allowed many biological attack. For example, the Strategic
diseases formerly treatable with drugs, like National Stockpile (SNS) has enough smallpox
tuberculosis (TB) and malaria to resurge vaccine to protect every man, woman, and child
and take hold with new vigor. in America and over 41 million treatment regi-
mens for anthrax.4 Along with vaccine manu-
The impact of emerging infectious diseases in
facturers, the federal government has invested
developing countries is well known and well
heavily in developing new vaccine technologies
documented. But these diseases can also
1
 for influenza and vaccines that are effective tackling polio in this country during the last
against the H5N1 avian influenza virus. In the century. Americans need and deserve a
past few years, stockpiles of antiviral medica- national game plan to protect them from
tions and vaccines that may be deployed dur- the wide range of infectious diseases that
ing a pandemic flu outbreak have been added threaten their well-being.
to the SNS.
Policymakers must start thinking of U.S.
On the other hand, many other emerging and contributions to prevent, treat, and cure
re-emerging diseases have received far less emerging infectious diseases as a national
attention. In the U.S., the private sector health imperative rather than as interna-
research and development pipeline for most tional good-will gestures. Leaders also must
emerging infectious diseases is stagnant or non- recognize that efforts to address biodefense
existent. Lack of action is fostered by a com- and emerging infections are mutually sup-
mon view that many of these diseases are limit- portive and that compartmentalizing these
ed to the developing world, and that vaccine efforts is arbitrary and counterproductive.
development and treatment options are not The response to emerging, re-emerging,
seen as profitable for U.S. pharmaceutical and deliberately-introduced infectious dis-
firms. Companies have found that the market eases requires a well-funded federal effort;
for new antibiotics, medications, and vaccines coordination with international initiatives;
for many infectious diseases is not as profitable and incentives that stimulate breakthroughs
as developing drugs to treat chronic conditions in research, surveillance, next-generation
like high cholesterol. Therefore, diagnostics diagnostics, treatments, and vaccines.
and treatment are outdated for infectious dis-
This issue brief examines what is currently
eases like TB and Staphylococcus aureus (often
known about a range of emerging infectious
referred to as “staph”). According to the U.S.
diseases and why they are potential threats
Food and Drug Administration (FDA), “devel-
to Americans. It also reviews the tools -- sur-
oping products targeted for ... less common dis-
veillance, diagnostics, vaccines, and thera-
eases, prevalent third world diseases, preven-
peutics -- that exist or are in development
tion indications, or individualized therapy is
and explores government incentives for
becoming increasingly challenging.”5
enhancing them. Finally, it recommends
The U.S. government should lead efforts to increased action to protect the nation from
detect and conquer emerging infectious dis- deadly and debilitating infectious diseases.
eases with the same energy it devoted to

Scanning electron micrograph of

HIV-1 budding from cultured
lymphocyte.

2
 U.S. INVESTMENTS IN INFECTIOUS DISEASE CONTROL IN OTHER
COUNTRIES PAY OFF
The U.S. cannot protect the health of its citizens without addressing infectious disease prob-
lems that are occurring elsewhere in the world. Helping other countries to control disease
outbreaks prevents those diseases from spreading to the U.S., saving lives and dollars.

Smallpox
The global eradication of smallpox in 1980, with support from the U.S. Department of Health
and Human Services and the U.S. Agency for International Development proved to be a pru-
dent economic investment for the nation’s health. In 1968, the U.S. spent $92.8 million on
smallpox vaccinations and revaccinations for Americans, or about $6.50 per vaccination.6
The U.S. spent a total of $32 million over a 10-year period in the global campaign to eradicate
smallpox -- the first and only infectious disease to be eradicated through human intervention.7
For all developed countries, the economic benefits of contributing to the WHO global small-
pox eradication program were substantial because costs associated with smallpox vaccine
preparation and administration, medical care, and quarantine were eliminated. The U.S., the
largest donor to the WHO effort, is estimated to save the total of all its contributions to the
smallpox eradication effort every 26 days.8
Over time, these savings are impressive. According to a General Accounting Office (GAO)
report, Infectious Diseases: Soundness of World Health Organization Estimates for Eradication or
Elimination, the cumulative savings from smallpox eradication for the U.S. was $17 billion
through April 1998.9

TB
A study published in the New England Journal of Medicine in September 2005 found that U.S.-
funded efforts to expand TB control programs in Mexico, Haiti, and the Dominican Republic
could reduce TB-related morbidity and mortality among migrants to the U.S. and produce net
cost savings for the federal government.10 The research team predicted the number of cases,
deaths and costs using the traditional U.S. approach of screening immigrants and refugees for
TB using chest X-rays obtained before or on arrival and subsequent treatment when detect-
ed, with expected outcomes if the U.S.-funded TB diagnosis and treatment programs in the
home country.
Particularly striking were the findings regarding Mexico, which is the single largest source of
immigrants to the U.S. The study found that if the U.S. government spent $35 million to
strengthen Mexican TB control, there would be a net savings of $108 million for the federal
government over 20 years.11
The study also predicted that there would be 2,591 fewer TB cases in the U.S., and 349
fewer TB-related deaths over the same time period, than if the current approach were con-
tinued. And these figures do not even account for the fact that preventing these cases will
prevent transmission of TB from immigrants to other U.S. citizens.
Similar U.S. government assistance for TB control in Haiti and the Dominican Republic would
also lead to long-term savings. A $9.4 million investment to expand TB diagnosis and treat-
ment programs in these Caribbean nations would result in a net saving for the U.S. of $20
million over a 20-year period.12

3
 1. WHAT ARE EMERGING AND RE-EMERGING
INFECTIOUS DISEASES?
In 1992, the Institute of Medicine (IOM) experts. For example, in the past 2
issued a landmark report, Emerging Infections: decades, countries in the Americas,
Microbial Threats to Health in the United States, Southeast Asia, and Western Pacific have
which defined the concept of emerging and witnessed a resurgence of dengue fever
re-emerging infections. It identified factors and its most serious manifestation, dengue
contributing to disease emergence and re- haemorrhagic fever.18 This past year, Brazil
emergence, and emphasized current and reported its first outbreak of yellow fever in
future challenges posed by infectious dis- urban areas since the 1940s.19
eases. The report broadly defined emerging
Malaria, nearly eliminated in the U.S., is ram-
infections as new, re-emerging, or drug-resist-
pant in developing countries, particularly in
ant infections whose incidence in humans
sub-Saharan Africa and South Asia. In 2003,
has increased within the past 2 decades or
the most recent year for which there are reli-
whose incidence threatens to increase in the
able data, there were 408 million malaria
near future.13 Recognition of an emerging
cases worldwide and 1.2 million deaths. No
disease occurs when the disease is identified
deaths were reported in the U.S., although
in humans or another species for the first
there have been sporadic cases reported.20
time or because links between an infectious
agent and a chronic disease or a syndrome More than one-third of the global popula-
have only recently been identified.14 tion is infected with TB and TB disease
remains one of the world’s leading causes of
In 1994, the U.S. Centers for Disease Control
disease and death. In 2006, there were 14.4
and Prevention (CDC) issued a strategic
million people living with active TB world-
plan emphasizing surveillance, research,
wide and approximately 2 million people
and prevention activities necessary to main-
die from the disease annually. The U.S.
tain a strong defense against infectious dis-
accounted for 9,842 of those cases in 2006.21
eases that affect, or threaten to affect, the
public’s health. It has become a roadmap for TB disease is usually treated with a regimen of
governmental infectious disease prevention drugs taken for 6 months to 2 years depend-
and control. Plan updates and progress ing on the type of infection. It is imperative
reports have been issued periodically.15 that people who have TB disease finish the
course of medicine, and take the drugs exact-
HIV/AIDS is an example of an emerging
ly as prescribed. If they stop taking the drugs
infectious disease that sparked a worldwide
too soon or do not take the drugs correctly,
pandemic. Globally, in 2007, nearly 33 mil-
they can become ill again and the infection
lion people were reported to be living with
may become more drug resistant.22
HIV.16 More than 980,000 cases of AIDS have
been reported in the U.S. since it was first There is a growing concern among public
reported in this country in 1981. Many more health officials about a continuum of drug-
Americans are infected with the virus but do resistant TB infections, which means that the
not have disease manifestations. Nearly 30 TB bacteria can no longer be killed by com-
years after emerging as a deadly infectious monly used antibiotics. As a result, the drug-
disease, there is still no vaccine or cure for resistant forms of the disease are more diffi-
HIV. While a combination of pharmaceuti- cult to treat than ordinary TB and require as
cal interventions, when used correctly, can much as 2 years of multidrug treatment, or
mitigate the effects of the disease and allow more in extreme cases.23
those infected to live many years with HIV, its
Recently, several U.S. states experienced
cost to society -- in terms of health care costs
measles outbreaks, which is particularly
and quality of life -- is enormous.
troubling because transmission of the dis-
Other new diseases recognized in the past ease was thought to be largely eliminated
few decades include SARS, hepatitis C, thanks to immunization. More than 130
H5N1 avian influenza viruses, Lyme disease, cases have been reported in the U.S. so far
and Legionnaire’s disease.17 this year, which constitutes the largest num-
ber since 2001. At least 15 patients, includ-
Re-emerging or resurging infectious dis-
ing 4 children have been hospitalized. In
eases are also of growing concern to health
4
the decade before the measles vaccination cant cause of vaccine-preventable death
program began, an estimated 3-4 million among children. In 2005, 311,000 children
persons in the U.S. were infected each year. under age 5 died from the disease globally.25
Of these, 400-500 died, 48,000 were hospi-
Additional information on several of the
talized, and another 1,000 developed chron-
world’s deadliest infectious diseases can be
ic disability from measles encephalitis.24
found in Appendix A. Descriptions of ani-
Worldwide, 20 million cases of measles still
mal-borne and foodborne diseases can be
occur each year, and the disease is a signifi-
found in Appendix B.

TABLE 1: Leading Infectious Causes of Death Worldwide, 2002

Cause Rank Estimated Number of Deaths
Respiratory infections 1 3,871,000
HIV/AIDS 2 2,866,000
Diarrheal diseases 3 2,001,000
Tuberculosis 4 1,644,000
Malaria 5 1,224,000
Measles 6 645,000
Pertussis 7 285,000
Tetanus 8 282,000
Meningitis 9 173,000
Syphilis 10 167,000
Source: WHO 2004 World Health Report

The potential deliberate use of pathogens tion in the future because of availability;
as agents of bioterrorism is of special con- ease of production and dissemination; and
cern in the post-9/11 world. CDC classifies potential for high morbidity and mortality
biological agents that could be used for an rates and major health impact. Hantavirus
intentional bioattack into 3 categories. is an example of a Category C agent.26
I Category A, or “High-Priority Agents,” is Developing effective medical countermea-
considered the most dangerous and sures against deliberately emerging diseases
includes: Anthrax, botulism, plague, has become a national priority. Congress
smallpox, tularemia, and viral hemor- and the Bush Administration have taken
rhagic fevers ( e.g., Ebola, Marburg). measures to encourage the stockpiling of
vaccines and medications to counter delib-
I Category B, or “Second-highest Priority
erately emerging infectious diseases. Project
Agents,” includes food safety threats (e.g.,
BioShield and the Biomedical Advanced
Salmonella and E. coli), ricin toxin, Typhus
Research and Development Authority
fever, and viral encephalitis, among others.
(BARDA) were created to stimulate private
I Category C, or “Third-highest Priority sector investment with direct federal sup-
Agents” include emerging pathogens that port for product development.
could be engineered for mass dissemina-

5
 ANTHRAX AS A BIOLOGICAL WEAPON
Anthrax is a potentially lethal infection caused by the bacterium Bacillus anthracis. Outside of a
host, this bacterium normally resides as a spore -- a hardy, dormant cell that may become
active (germinate) in the right conditions. Anthrax generally affects large grazing animals, but it
can also infect humans who handle products of infected animals. However, deliberate expo-
sure to aerosolized anthrax spores also is a highly effective means of transmission.27
That is why anthrax is considered by many to be the ideal bioweapon. It is extremely stable
and can be stored almost indefinitely as a dry powder. The costs of producing anthrax mate-
rial are relatively low and knowledge about production is widely available and does not
require high degrees of technology. According to the U.S. Department of Defense (DOD),
anthrax is easy to weaponize and can be loaded, in a freeze-dried condition, in munitions or
disseminated as an aerosol with crude sprayers.28 Currently, detection of this silent, invisible
killer is limited. In 1999, CDC classified anthrax as a Category A bioterrorism agent, which
means it poses the highest level of threat to national security. However, unlike some other
Category A agents (e.g. smallpox), anthrax does not spread from person to person, thus limit-
ing the risk to those directly exposed in an attack.29
Historically, numerous nations have experimented with anthrax as a biological weapon, includ-
ing the U.S. offensive biological weapons program that was disbanded in 1969.30 The worst
documented outbreak of inhalation anthrax in humans occurred in Russia in 1979, when
anthrax spores were accidentally released from a military biological weapons facility near the
town of Sverdlovsk, killing at least 66 people. In the fall of 2001, lethal anthrax bacteria were
spread deliberately through the U.S. Postal Service. Seventeen people became ill, and 5 died.

SMALLPOX AND BIOTERRORISM

Although the World Health Organization (WHO) declared that smallpox was eradicated in
1980, this contagious and deadly infectious disease caused by the Variola major virus, remains
high on the list of possible bioterror threats.
The last naturally occurring case of smallpox was reported in 1977. Currently, there is no evi-
dence of naturally occurring smallpox transmission anywhere in the world. Although a world-
wide immunization program eradicated smallpox disease decades ago, small quantities of
smallpox virus officially still exist in research laboratories in Atlanta, Georgia, and in
Novosibirsk, Russia.31 There is a fear there may be other unknown sources of smallpox virus
that could fall into the hands of terrorists.
In January 2003, the Bush Administration declared smallpox the “number one bio-threat fac-
ing the country” and made planning for an attack a top priority.32 The Administration
launched a national smallpox vaccination initiative with the goal of immunizing 500,000 health
care workers in 30 days and 10 million emergency response personnel within a year.
Immunization rates fell well-below that target level with approximately 40,000 people actually
vaccinated. The plan faced obstacles, including unexpected side effects, worker compensation
issues, and liability concerns that precluded its full implementation.33

6
 NEGLECTED TROPICAL DISEASES
Recently, neglected tropical diseases have garnered increasing international attention. The
leaders of Canada, France, Germany, Italy, Japan, Russia, the United Kingdom, and the U.S.
met at the G8 Summit in Japan in July 2008. Japan’s Prime Minister, Yasuo Fukuda, summa-
rized their position on neglected tropical diseases:
“We ... agreed to support the control or elimination of neglected tropical diseases (NTDs) to
reach at least 75 percent of the people with NTDs. We also discussed the timeframe to provide
US$ 60 billion to fight infectious diseases and strengthen health, and agreed to do so over 5 years,
while some countries will provide additional resources for health systems including water.”34
Health officials estimate that one billion people -- one sixth of the world’s population -- suffer
from one or more neglected tropical disease. Extreme poverty, war and civil conflicts, and
natural disasters aggravate conditions that are conducive to the spread of these diseases. Lack
of comprehensive surveillance, unreliable statistics, and the diseases’ obscure names con-
tribute to their low profile and status among global public health priorities.
WHO considers the following to be neglected tropical diseases: Buruli ulcer, dengue/dengue
haemorrhagic fever, dracunculiasis (guinea-worm disease), fascioliasis, human African try-
panosomiasis (sleeping sickness), leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis,
schistosomiasis, soil-transmitted helminthiases, trachoma, and yaws.35

2. FACTORS CONTRIBUTING TO THE EMERGENCE

OF INFECTIOUS DISEASES
Emerging and re-emerging infectious dis- complacency ... Infectious diseases unknown
eases pose serious threats to the health of in this country just a decade ago, such as West
the American people. In 2003, the IOM Nile encephalitis and hantavirus pulmonary
issued Microbial Threats to Health: Emergence, syndrome, have emerged to kill hundreds of
Detection, and Response, an important follow Americans -- and the long-term consequences
up to the 1992 IOM report on emerging for survivors of the initial illnesses are as yet
infectious diseases. The 2003 IOM report unknown. Other known diseases, including
assessed the threats of emerging infectious measles, multidrug-resistant tuberculosis, and
diseases to the U.S. and warned: even malaria, have been imported and trans-
mitted within the United States in the last 10
“While dramatic advances in science and med-
years... Compounding the threat posed by
icine have enabled us to make great strides in
these infectious diseases is the continuing
our struggle to prevent and control infectious
increase in antimicrobial resistance.”36
diseases, we cannot fall prey to an illusory

TABLE II: FACTORS OF EMERGENCE

I Microbial adaptation and change I International travel and commerce
(i.e., drug resistance) I Technology and industry
I Human susceptibility to infection I Breakdown of public health measures
I Climate and weather I Poverty and social inequality
I Changing ecosystems I War and famine
I Human demographics and behavior I Lack of political will
I Economic development and land use I Intent to harm
Source: 2003 IOM Report: Microbial Threats to Health: Emergence, Detection, and Response.

7
 Antimicrobial (Drug) Resistance

“ IN THEIR ONGOING WAR AGAINST ANTIBIOTICS, THE BACTERIA SEEM TO BE

WINNING, AND THE DRUG PIPELINE IS VERGING ON EMPTY...THE LAST DECADE HAS

SEEN THE INEXORABLE PROLIFERATION OF A HOST OF ANTIBIOTIC-RESISTANT BACTERIA,

OR BAD BUGS, NOT JUST MRSA BUT OTHER INSIDIOUS PLAYERS AS WELL.

”
37

-- SCIENCE

Antimicrobial resistance is a serious patient that can identify infectious agents, poor infec-
safety and public health issue. According to the tion control in health care and community set-
National Institute of Allergy and Infectious tings, and poor hand hygiene. The use of
Diseases (NIAID), “antimicrobial drug resist- antibiotics in agriculture and aquaculture also
ance is the ability of a microbe to grow in the contributes significantly to antimicrobial
presence of a chemical that would normally kill resistance.40 Preventing infection and decreas-
it or limit its growth.”38 Disease-causing ing inappropriate antibiotic use are important
microbes that have become hard to treat with strategies for controlling resistance.
antibiotic drugs include E. coli, Salmonella,
Staphylococcus aureus, and those causing TB,
gonorrhea, and malaria, among others. People Difference Between Non-Drug Resistant
infected with antimicrobial-resistant organisms And Drug Resistant Bacteria
are more likely to have longer hospital stays and
may require more complicated treatment.
A class of drug resistant bacteria known as
“gram-negative” is particularly hard to treat.
One strain, acinetobacter baumannii, has
threatened the lives, limbs, and organs of
hundreds of U.S. forces fighting in Iraq and
Afghanistan. According to DOD documents,
more than 250 patients at U.S. military hos-
pitals were infected with a highly resistant
strain of acinetobacter between 2003 and
2005, with 7 deaths as of June 2006, linked to
acinetobacter-related complications.39
Antimicrobial resistance is exacerbated by the
overuse and misuse of antibiotics in people Source: National Institute of Allergy and Infectious
and animals, the lack of rapid diagnostic tests Diseases, www.niaid.nih.gov

2005 colorized scanning electron

micrograph (SEM) depicts
numerous clumps of methicillin-
resistant Staphylococcus aureus
(MRSA) bacteria. Methicillin-
resistant Staphylococcus aureus
infections, e.g., bloodstream,
pneumonia, bone infections,
occur most frequently among
persons in hospitals and health-
care facilities, including nursing
homes, and dialysis centers.

8
 MRSA
Methicillin-resistant Staphylococcus aureus (MRSA) infection is caused by Staphylococcus aureus
bacterium. Often called “staph,” this organism is a common cause of serious skin, soft tissue,
and bloodstream infections. The advent of antibiotics revolutionized the treatment of staph
infections, greatly reducing morbidity and mortality. MRSA is a strain of staph that is resistant to
broad-spectrum antibiotics commonly used to treat it. MRSA is a growing cause of fatal staph
infections,41 causing potentially life-threatening infections in bones, joints, surgical wounds, the
bloodstream, heart valves, and lungs.42
In the past, most invasive MRSA infections occurred in hospitals or other health care settings,
such as nursing homes and dialysis centers. This is known as health care-associated MRSA, or HA-
MRSA. Older adults and people with weakened immune systems are at most risk of HA-MRSA.43
More recently, community-associated MRSA, or CA-MRSA, has become increasingly responsible
for serious skin and soft tissue infections and for a serious form of pneumonia among previously
healthy persons.44 The deaths of 2 previously healthy school children in October 2007 -- one in
Virginia and the other in New York -- have significantly increased public awareness about this
serious public health concern. CA-MRSA rates continue to rise at an alarming rate, now
accounting for more than half of community-acquired staff infections in many communities.45
Both HA- and CA-MRSA infections are painful, difficult to treat, and cost the U.S. health care
system many billions of dollars annually. While both types of MRSA still respond to a few
medications, intravenous vancomycin is the mainstay for treating severe MRSA infections and
there are growing concerns that this medication may be losing its effectiveness. Some U.S.
hospitals report seeing strains of MRSA that are less easily killed by vancomycin, and 7 cases of
complete resistance were reported in this country between 2000-2006.46

Globalization
Globalization, the worldwide movement Lower cost and efficient means of interna-
toward economic, financial, trade, and com- tional transportation allow people to travel
munications integration, has impacted pub- to more remote places and potential expo-
lic health significantly. Technology and eco- sure to more infectious diseases. And the
nomic interdependence allow diseases to close proximity of passengers on passenger
spread globally at rapid speeds. Experts planes, trains, and cruise ships over the
believe that the increase in international course of many hours puts people at risk for
travel and commerce, including the increas- higher levels of exposure. If a person con-
ingly global nature of food handling, pro- tracts a disease abroad, their symptoms may
cessing, and sales contribute to the spread not emerge until they return home, having
of emerging infectious diseases.47 Increased exposed others to the infection during their
global trade has also brought more and travels. In addition, planes and ships can
more people into contact with zoonosis -- themselves become breeding grounds for
diseases that originated in animals before infectious diseases.
jumping to humans. For example, in 2003,
The 2002-2003 SARS outbreak spread quickly
the monkeypox virus entered the U.S.
around the globe due to international travel.
through imported Gambian giant rats sold
SARS is caused by a new strain of coronavirus,
in the nation’s under-regulated exotic pet
the same family of viruses that frequently
trade. The rats infected pet prairie dogs,
cause the common cold. This contagious and
which passed the virus along to humans.48
sometimes fatal respiratory illness first
International smuggling of birds, brought
appeared in China in November 2002. Within
into the U.S. without undergoing inspection
6 weeks, SARS had spread worldwide, trans-
and/or quarantine, is of particular concern
mitted around the globe by unsuspecting trav-
to public health experts who worry that it
elers. According to CDC, 8,098 people were
may be a pathway for the H5N1 “bird flu”
infected and 774 died of the disease.49
virus to enter the country.

9
 SARS represented the first severe, newly ruption and economic losses. Schools, hos-
emergent infectious disease of the 21st cen- pitals, and some borders were closed and
tury.50 It illustrated just how quickly infec- thousands of people were placed in quaran-
tion can spread in a highly mobile and inter- tine. International travel to affected areas
connected world. SARS was contained and fell sharply by 50 - 70 percent. Hotel occu-
controlled because public health authorities pancy dropped by more than 60 percent.
in the communities most affected mounted Businesses, particularly in tourism-related
a rapid and effective response. areas, failed. According to a study by Morgan
Stanley, the Asia-Pacific region’s economy
SARS also demonstrated the economic con-
lost nearly $40 billion due to SARS.51 The
sequences of an emerging infectious disease
World Bank found that the East Asian
in closely interdependent and highly mobile
region’s GDP fell by 2 percent in the second
world. Apart from the direct costs of inten-
quarter of 2003.52 Toronto experienced a
sive medical care and disease control inter-
13.4 percent drop in tourism in 2003.53
ventions, SARS caused widespread social dis-

10
Environmental Factors
Geophysical phenomena such as shifts in
temperature, wind, and rainfall patterns can
precipitate the appearance of new diseases in
new places. Weather and climate affect dif-
ferent diseases in different ways. For exam-
ple, diseases transmitted by mosquitoes, such
as dengue fever, Rift Valley fever, and yellow
fever are associated with warm weather (addi-
tional information on these diseases can be
found in Appendix B) and experts believe
that an El Niño occurrence (a fluctuation of
the ocean-atmosphere system in the tropical
Pacific having important consequences for
weather around the globe), may be a factor
in the resurgence of malaria and cholera.54
On the other hand, influenza becomes epi-
demic primarily during cool weather.
Meningococcal meningitis is associated with
dry environments, while cryptosporidiosis
outbreaks are associated with heavy rainfall,
which can overwhelm sewage treatment
plants or cause lakes, rivers and streams to
become contaminated by runoff which con-
tains waste from infected animals.
Climate changes in North America are
believed to be responsible for the growing
populations of 2 new species of mosquitoes,
including Asian tiger mosquitoes, in the
continental U.S. These insects, which are
believed to be successful bearers, or “vec-
tors,” of diseases like LaCrosse encephalitis,
yellow fever, dengue fever, and West Nile
virus, now infest more than 30 states.55
Large scale climatic change may also have an
effect on the timing of migration of wild
birds, which in turn can impact the move- rates of deforestation have grown signifi-
ment of other species such as ticks and lice. cantly since the beginning of the 20th cen-
Wild birds are important to public health tury. Driven by rapidly increasing human
because they can be infected by a number of population numbers, large areas of tropical
microbes that can then be transmitted to and temperate forests, as well as prairies,
humans. In addition, birds migrating across grasslands, and wetlands, have been con-
national and intercontinental borders can verted to agricultural and ranching uses.
become long-range carriers of any bacteria, The result has been an upsurge of certain
virus, parasite, or drug-resistant organism infectious diseases, as the relationships
they harbor.56 Wild birds are believed to be between humans and disease vectors (carri-
key to the rapid spread of West Nile virus ers) shift. Deforestation, with subsequent
across the entire country just 3 years after the changes in land use and human settlement
first case was identified in New York in 1999. patterns, has coincided with increased
Similarly, migratory birds are being closely malaria prevalence in Africa, Asia, and Latin
observed by human health and veterinary America.58 Conversely, reforestation in the
health officials as they monitor the spread of Northeastern and the upper Midwest
the H5N1 avian influenza virus worldwide.57 regions of the U.S. has promoted an
Deforestation and reforestation also can be increase in the population of the white-
factors in the spread and prevalence of cer- tailed deer, an important host for the ticks
tain emerging infectious diseases. Globally, that carry Lyme disease.59

11
 Social Inequities, Geopolitical Events, and Human Behavior
A number of societal factors contribute to with diarrhea, can lead to malnutrition in
the emergence and re-emergence of infec- young children, so that diarrheal illness is
tious disease. Poverty, lack of access to health both a cause and an effect of malnutrition.61
care, poor sanitation, unsafe water, and a lack
War and civil strife generally result in a
of proper hygiene all contribute to the
breakdown of domestic stability, food and
expanding impact of infectious diseases.
water shortages, and destruction of the
Overcrowded and poor living conditions medical infrastructure, including existing
make people living in poverty especially vul- vaccination programs. Refugee camps often
nerable to communicable diseases such as TB are crowded and dirty, with little or no
and cholera. Limited access to health care access to medical care or protection from
and medicine can render otherwise treatable disease transmission.62
conditions such as malaria and TB fatal for
High-risk behaviors continue to be an
those living in poverty. Urban decay and
important factor in the transmission of
squalid living conditions and the presence of
some infectious diseases. Sexual behavior
vermin also contribute to the spread of infec-
and use of intravenous drugs continue to be
tions, such as plague. Meanwhile, contami-
primary modes of HIV transmission, and
nated water and inadequate sewage treatment
public health efforts over the last few
systems in impoverished nations contribute to
decades have demonstrated how difficult
the spread of infectious diseases like cholera.60
such behaviors are to change. In developing
Poor nutrition and compromised immune nations, ignorance of preventive measures
systems are also key risk factors for several and the absence of social agencies to teach
major diseases including lower respiratory the avoidance of risky behaviors exacerbate
infections, TB, and measles. There is the problem. Once diagnosed with a partic-
increasing evidence that suggests that mal- ular disease, failure to comply with pre-
nutrition is the underlying reason for scribed treatment regimens is another fac-
increased susceptibility to infectious dis- tor of transmission. The emergence of drug-
eases especially in children. At the same resistant TB can be attributed in large part
time, infections, especially those associated to poor patient compliance with therapy.63

PARASITIC DISEASES AND POVERTY IN THE U.S.

Parasitic diseases are rare in the U.S. However, these diseases have been found in certain low-
income communities. Researchers find at-risk populations to include “people of color living in
the Mississippi Delta and elsewhere in the American South, in disadvantaged urban areas, and
in the U.S.-Mexico borderlands, as well as in certain immigrant populations and disadvantaged
white populations living in Appalachia.”64 Natural disasters, compounded by poverty, can also
lead to spikes in these diseases, as was the case post-Hurricane Katrina along the Gulf Coast.
Some of the top exiting parasitic threats currently in the U.S. include:
I Ascariasis -- the most common worm infection in humans. It is caused by a parasitic worm
that lives in the intestine, and infected just under 4 million people in 1974 according to the
last survey, in the South and Appalachia.
I Toxocariasis -- a roundworm parasite transmitted in dog droppings. It has the potential to
cause intestinal illness and blindness, according to the CDC, and infect up to 14 percent of
the U.S. population. So far, this parasite has infected up to 2.8 million poor black children in
inner cities, the South and Appalachia.65
I Strongyloidiasis -- caused by a threadworm that lives throughout the body and can cause
hyper-immune reactions, and infects 68,000 to 100,000 people each year.
I Cysticercosis -- associated with the pork tapeworm.
I Giardiasis -- diarrheal illness caused by a one-celled parasite.
Not all of these diseases are life-threatening, but they can lead to symptoms and complications
that make the lives of people in poverty even harder. Chronic conditions that can develop
from these diseases include asthma, epilepsy, diarrhea, fever and heart disease, which can
adversely affect child development and hearing, as well as professional and financial stability.

12
3. IMPACT OF EMERGING INFECTIOUS DISEASES
AT HOME
Emerging infectious diseases already pose a are increasingly commonplace. And, the U.S.
domestic health crisis. has experienced its first deliberate and lethal
attack using a biological agent as a weapon.
West Nile virus is now endemic in the U.S.
American troops are returning from Iraq and Emerging and re-emerging infectious dis-
Afghanistan with highly drug resistant bacte- eases pose risks for all Americans. For exam-
rial infections. Increasingly, locker rooms ple, if a severe infuenza outbreak were to
and gymnasiums are sources of staph infec- occur, the U.S. government estimates that as
tions. A heretofore unknown pathogen -- many as 90 million Americans could become
SARS -- emerged, causing illness, death, and sick and 2 million might die.66 The conse-
economic mayhem. Public health officials quences of a bioterror attack involving small-
remain on high alert for the first sign that the pox or anthrax are almost unfathomable.
deadly H5N1 avian influenza virus has
While U.S. public health officials must be
breached U.S. borders. An American citizen
prepared for such scenarios, they remain
thought to have XDR-TB exposed the vul-
hypothetical. There are, however, a number
nerability of the U.S. public health system.
of emerging and re-emerging infections that
Deadly foodborne disease outbreaks from
are real threats to the health of Americans as
domestic and imported agricultural products
well as the U.S. economy today.

High Prevalence Rates and High Costs

There are 1.2 million people living with of the American Medical Association estimated
HIV/AIDS in the U.S., including more than that MRSA infects more than 94,000 people
440,000 with AIDS.67 There are an estimated and kills nearly 19,000 annually nationwide.73
56,300 new cases of HIV diagnosed in this That makes it the sixth leading cause of death
country every year.68 Nearly 566,000 in the U.S. MRSA-specific studies suggest that
Americans have died of AIDS since 1981.69 the additional cost of treating an antibiotic-
African Americans accounted for 49 percent resistant staph infection versus one that is not
of new HIV infections diagnosed in the U.S. resistant range from a minimum of $3,000 to
in 2006, although they comprise only 13.8 more than $35,000 per case. In 2005, such
percent of the population. The HIV infec- infections cost the health care system
tion rate among African Americans is 7 (patients and hospitals) an extra $830 million
times higher than the rate among whites. to $9.7 billion, before taking into account
The infection rate among Latinos is 3 times indirect costs related to patient pain, illness,
higher than the rate among whites.70 and time spent in the hospital.74
As devastating as the health consequences of Hepatitis C is a liver disease caused by HCV
this infectious disease may be, the costs of treat- and is transmitted through blood or other
ing HIV/AIDS are equally staggering. The body fluids. These infections sometimes result
annual per-patient medical expenses associated in an acute illness, but most often become a
with doctor appointments, laboratory tests, and chronic condition that can lead to cirrhosis of
drugs to prevent or treat HIV-related oppor- the liver and liver cancer.
tunistic infections average from $18,000 -
In 2006, there were an estimated 19,000 new
$20,000, with even higher costs for those with
hepatitis C virus infections in the U.S. and an
more advanced HIV-related illness. These costs
estimated 3.2 million Americans have chronic
do not include those related to lost productivity.
hepatitis C virus infection. Approximately 8,000-
The costs to the American taxpayer are also 10,000 people die every year from hepatitis C
high. In Fiscal Year 2007, total federal spending related liver disease.75 It is the leading cause of
on HIV/AIDS-related medical care, research, cirrhosis and liver cancer and the most com-
prevention, and other activities in the U.S. was mon reason for liver transplantation in the U. S.
$23.3 billion.71 Additionally, during the same
According to the American Liver Foundation,
time period, the share of state-Medicaid spend-
medical expenditures for people with hepati-
ing on AIDS was estimated to be $5.5 billion
tis C are estimated to be $15 billion annually.
and states reported spending $294 million on
The projected direct and indirect costs of
their AIDS Drug Assistance Programs.72
hepatitis C will be $85 billion for the years
The MRSA numbers are alarming too. A 2007 2010-2019, as the number of people chroni-
CDC-supported study published in the Journal cally infected will likely continue to increase.76
13
 HEPATITIS C OUTBREAK IN LAS VEGAS
In February 2008, CDC investigators responded to a request from the Nevada health officials
to help investigate 3 cases of hepatitis C (HCV) in people who had undergone procedures at
the same Las Vegas endoscopy clinic. Three additional cases were identified later. During the
investigation of the clinic, where routine colonoscopies were performed, health officials found
that the re-use of syringes was the likely cause of transmission. Forty-thousand people were
then notified that they might have been exposed to HIV and HCV, in what a federal health
official called the largest notification of its kind in U.S. history.77 The clinic was subsequently
shut down by city officials.

Infections Making a Comeback

In addition to emerging infections, Americans tions occurred among immigrants, refugees,
also are increasingly at risk from re-emerging and foreign visitors, compared with a little
infectious diseases. For example, after seeing a more than 4 percent of U.S.-born residents
decline in TB cases in the U.S. over the last with active TB infection.79
decade, this contagious airborne disease
Additional information on latent TB and
could be on an upswing
active TB infection can be found in
Of particular concern is the number of cases Appendix A.
of drug-resistant TB found in foreign-born
Other infectious diseases, once thought to be
individuals now residing in the U.S. According
under control, have experienced recent out-
to a study conducted by CDC researchers, 57
breaks in the U.S. They include pertussis
percent of all TB cases in the U.S. were among
(especially among adolescents), mumps, and
foreign-born individuals in 2006.78 Approx-
measles, all of which are vaccine-preventable.
imately 10 percent of drug-resistant TB infec-

AN INTERNATIONAL TB SCARE
The threats posed by XDR-TB garnered public attention in May 2007, when Andrew Speaker, a
U.S. citizen with drug-resistant tuberculosis, led public health officials on a trans-Atlantic chase.
The incident began when Speaker flew to Europe on a commercial airline for his wedding and
honeymoon. He was aware that he had an active case of drug-resistant TB, but it was not
until he was out of the U.S. that tests suggested he had XDR-TB. CDC officials tracked
Speaker down in Rome and asked him to turn himself into Italian health officials. Instead, he
and his wife flew commercially to Prague, then on to Montreal, and drove by car back into
the U.S. Speaker claims he took these actions because CDC indicated that he would be held
in Italian quarantine for up to 2 years.
Out of concern that Speaker could have infected fellow travelers with the disease, health offi-
cials advised anyone who flew with him on the trans-Atlantic flights to be tested.
Subsequently, Speaker was treated at the National Jewish Medical and Research Center in
Denver, where it was announced that Speaker’s earlier diagnosis was incorrect and that he
instead had the more treatable MDR-TB. CDC later confirmed this diagnosis.
The incident raised serious questions about the effectiveness and timeliness of TB testing, U.S.
border security, and the practicality of international restrictions on travel by people with infec-
tious diseases. A Congressional investigation into the incident found significant security gaps,
heightening concern about vulnerability to potential cases of pandemic influenza or smallpox.

14
 DENGUE FEVER NIPPING AT OUR BORDERS
Dengue fever is a flu-like illness that can be painful and debilitating and is sometimes referred to
as “break bone” fever that is transmitted by mosquitoes. The more severe dengue hemorrhagic
fever and dengue shock syndromes can be fatal.80
Most common in tropical and subtropical regions, public health experts believe that dengue is
one of the world’s most important re-emerging diseases. Worldwide, 50 to 100 million cases
of dengue infection occur each year. This includes 100 to 200 cases in the U.S., mostly in peo-
ple who have recently traveled abroad. Many more cases likely go unreported because some
health care providers do not recognize the disease.
Mosquitoes that can transmit the illness have been found in 36 U.S. states and are of particu-
lar concern along the U.S.-Mexico border and in Puerto Rico.81 In 2001, there was a dengue
fever epidemic in Hawaii that sickened at least 120 people.82

Food-Related Infectious Diseases on the Rise

“ FOODBORNE ILLNESSES ARE DEFINED AS DISEASES, USUALLY EITHER INFECTIOUS

OR TOXIC IN NATURE, CAUSED BY AGENTS THAT ENTER THE BODY THROUGH THE

INGESTION OF FOOD. EVERY PERSON IS AT RISK OF FOODBORNE ILLNESS.

”
83

-- WORLD HEALTH ORGANIZATION

Infectious diseases transmitted by foods an outbreak of bloody diarrhea traced to

have become a major public health concern hamburgers from a fast-food chain.86
in recent years. It seems that hardly a Cyclospora emerged in 1992 as a foodborne
month goes by without the report of a food- pathogen, and was later traced to outbreaks
borne illness outbreak in the U.S. in the U.S. from imported Guatemalan rasp-
berries.87 In March 2008, melons imported
Approximately 76 million Americans -- nearly
from Honduras caused Salmonella infections
one-quarter of the U.S. population -- are sick-
in 16 states; and beginning in April 2008, a
ened by foodborne disease each year. Of these,
Salmonella outbreak, thought to be associat-
an estimated 325,000 are hospitalized and
ed with jalapeño and Serrano peppers
5,000 die. Medical costs and lost productivity
imported from Mexico, sickened at least
due to foodborne illnesses are estimated to
1,400 Americans in 43 states.88 In 2007, the
cost $44 billion annually.84 Major outbreaks can
U.S. Department of Agriculture issued 20
also contribute to significant economic losses
separate meat recalls due to potential E. coli
in the agriculture and food retail industries.85
contamination, and in February 2008, the
Several new foodborne pathogens have department issued its largest beef recall in
emerged over the last few decades. E. coli history -- 143 million pounds of beef -- from
O157:H7 was first identified in 1982 during a California meatpacking company.89

“I, for the life of me, cannot understand why the terrorists have not attacked our
food supply, because it is so easy to do.”
-- FORMER U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES SECRETARY, TOMMY THOMPSON,
DECEMBER 2004.
Agroterrorism is the “deliberate introduction of an animal or plant disease with the goal of
generating fear, causing economic losses, and/or undermining stability.”90
The deliberate contamination of our nation’s food supply is a serious threat that could have a
quick, widespread impact. In January 2004, the Bush Administration responded to this very
real threat with Homeland Security Presidential Directive/HSPD- 9, “Defense of United States
Agriculture and Food.”91 This directive calls for a coordinated national approach to countering
threats to the food supply.

15
 4. THE NEED TO IMPROVE INFECTIOUS
DISEASE PREVENTION
Scientists worldwide -- government and aca- and should, improve and expand its diagnos-
demic, together with their industry partners tic and disease surveillance capabilities, and
and international collaborators -- have made dramatically increase its investment in devel-
great strides in understanding emerging and oping new treatments and vaccines. Scientists
re-emerging infectious diseases. Many of also need to better understand mechanisms
these discoveries have resulted in novel diag- of drug resistance and develop new ways to
nostics, anti-infective therapy, and vaccines. circumvent this growing public health threat.
Yet, much remains to be done. The U.S. can,

Surveillance
Disease surveillance is defined as the “system- 2008 multi-state foodborne outbreak, which
atic collection and analysis of data and the pro- initially implicated tomatoes before identify-
vision of information which leads to action to ing the source as peppers. Or consider the
prevent and control a disease, usually of an possibility of a domestic outbreak of a new
infectious nature.”92 The primary purpose of strain of influenza virus.
disease surveillance is to predict, observe, and
That is why CDC should make it a priority to
minimize harm caused by outbreaks, pan-
ensure that every state and local health depart-
demics, and pandemic situations, as well as to
ment in the U.S. is part of a 21st-century dis-
better understand what factors might con-
ease surveillance system that is interoperable
tribute to the spread of the disease. In the
among jurisdictions and agencies to ensure
U.S., state and local health departments, in
rapid information sharing. Surveillance sys-
collaboration with CDC, are responsible for
tems should be able to detect and characterize
disease surveillance. The National Electronic
known infectious disease outbreaks, new syn-
Disease Surveillance System (NEDSS), a com-
dromes (e.g., SARS in 2003), or a bioterrorist
ponent of the Public Health Information
attack. Plans should ensure adequate labora-
Network (PHIN), is a CDC-led initiative that
tory surveillance of influenza and other infec-
was developed to integrate and standardize
tious diseases, as well as testing for pathogens
the tracking of infectious diseases at the local
such as E. coli and XDR-TB.
level. Additionally, BioSense, another compo-
nent of PHIN, collects syndromic surveillance, Furthermore, CDC should consider how
like patients’ symptoms, quantities and types health information technology (HIT) can be
of prescriptions, and emergency room visits to mobilized far more effectively to improve sur-
alert health officials to possible disease out- veillance capability and overall public health
breaks or health emergencies. preparedness. When coordinated, HIT sys-
tems can facilitate data exchange among
The U.S. government also implements or par-
public health partners and facilitate the man-
ticipates in more than 25 specialized systems
agement of data from health care delivery
for monitoring diseases. The networks include
facilities, laboratories, and health agencies.
the Global Emerging Infectious Diseases
Sentinel Network, also known as GeoSentinel; At the same time the U.S. needs to be a
EMERGEncy ID NET; the Foodborne Dis- leader in efforts designed to accurately
eases Active Surveillance Network (FoodNet); assess the burden of infectious diseases in
the Active Bacterial Core Surveillance System; developing countries, detect the emergence
the National Respiratory and Enteric Virus of new microbial threats, and direct global
Surveillance System; the National Tuber- prevention and control efforts. The
culosis Genotyping and Sur veillance Network; nation’s endorsement and subsequent com-
and the National Influenza Surveillance pliance with the 2005 revisions to the
Systems, among others. International Health Regulations (IHR),
which encourage nations to work together
Despite this proliferation of networks, the
to take preventive measures against, as well
overall system of disease surveillance in the
as detect, report on, and respond to, public
U.S. has not developed into a robust, coor-
health emergencies of international con-
dinated capability. Consider for example,
cern, is a step in the right direction.
the delay in identifying the source of the
16
Most traditional global disease surveillance infectious disease threats. Many public health
programs target only specific diseases (e.g., officials support expansion of these existing
influenza or polio) and the infrastructure systems because infectious diseases -- often of
and support is relatively weak for the more animal origin -- are a major cause of morbid-
difficult task of tracking emerging and re- ity and mortality in poorer populations, and
emerging infectious diseases. This is espe- such environments frequently serve as incu-
cially true in developing countries, where bators for emerging pathogens.93
scarce human and material resources may
The U.S. should enhance its commitment to
not support even routine surveillance tasks,
the 2005 IHR revisions by increasing support
such as the recording of births and deaths.
for CDC’s Coordinating Office for Global
Recent international initiatives to expand
Health, including expanding the number of
capacity for the detection and surveillance of
its Global Disease Detection Centers.
HIV/AIDS and avian influenza have not
Similarly, DOD and NIH should expand and
been broadened to enable a look at all major
increase overseas program sites and research.

INTERNATIONAL HEALTH REGULATIONS (2005)

The International Health Regulations (2005) (IHR) govern the roles of WHO and 194 nations
(Member States) with respect to disease outbreaks and other public health events with inter-
national impact. The regulations update the previous version of the IHR, which was adopted
in 1969. They are designed to prevent and protect against the international spread of diseases
while minimizing interference with world travel and trade.
The revised IHR, which became effective in 2007, gives WHO clearer authority to recommend
to its Member States measures that will help contain the international spread of disease, including
public health actions at ports, airports, and land borders, and on means of transport that involve
international travel. The revised regulations include a list of 4 diseases -- smallpox, polio, SARS,
and human cases of new subtypes of human influenza -- that Member States must immediately
report to WHO. The U.S. government began complying with the revised IHR on July 18, 2007.94

Diagnostics
New rapid diagnostic tests are needed across A focus on point-of-care testing is particu-
the spectrum of emerging infectious dis- larly important. Developments in nanotech-
eases. Many existing diagnostic tools are nology have the potential to improve sensi-
outdated and difficult to use. For example, tivity and specificity of point-of-care, hand-
the standard test for diagnosing active TB in held diagnostics over time and at a potential
most of the world is smear microscopy, gen- cost-savings over current technology. This
erally of s sputum sample. Quality samples type of diagnostic tool would be particularly
are hard to obtain; moreover, this test is over useful during an influenza pandemic.
100 years old and is only 50 percent accu-
The next generation of effective diagnostic
rate, and cannot determine drug suscepti-
tools needs to be made available worldwide
bility. Failure to quickly and accurately
for use by a workforce that has been ade-
detect infections, such as TB, can be deadly
quately trained in their use. Also, given that
and costly. There is more opportunity for an
35 of the most recent emerging diseases,
infection to spread that longer that it goes
including avian influenza, monkeypox, West
undetected. In addition, the infection is
Nile Virus and SARS, have been zoonotic
more likely to be treated with a broad spec-
(animal-borne) in origin,96 updated diag-
trum drug, which increases the risk for
nostic tools to improve disease detection in
resistance and adverse outcomes.
animals should also be a priority.

17
 CLINICAL TRIALS FOR NEW ANTIBIOTICS ARE CHALLENGING
A clinical trial is the scientifically controlled study of the safety and effectiveness of a drug or
vaccine, using consenting human subjects.
Clinical trials for new antibiotics are complicated and time consuming. Finding enough
patients to enroll in clinical trials of new drugs to treat resistant pathogens is not easy. For
many resistant pathogens, there are no rapid diagnostic tests available to help researchers to
identify patients who would be eligible for their studies. By contrast, when enrolling patients
in a clinical trial to test a new cancer drug, researchers know from the start whether a specific
patient has the specific type of cancer they are targeting. With antibiotic clinical trials, that is
not necessarily the case. As one industry consultant explained, in order to test a drug that is
intended to treat resistant strains, “You have to wait for epidemics to break out in hospital
wards, and you can’t predict when that will happen. It may take 5 years to complete a clinical
study.”97 That is one of the reasons that the need for new rapid diagnostics to detect drug
resistant bacteria infections is particularly acute.

Treatment
While dramatic advances in science and action, with no cross-resistance with other
medicine have enabled scientists, medical antibiotics). In 2002, among 89 new medi-
practitioners, and public health officials to cines emerging on the market, none was an
make great strides in the struggle to control antibiotic.”99 This trajectory needs to change.
and treat infectious diseases, there is a sig-
The development of new, improved thera-
nificant amount of research, development,
pies to treat drug resistant bacterial infec-
and testing that remains to be done.
tions, as well as for influenza and other virus-
Once considered “miracle drugs,” antibi- es is essential. According to FDA, because of
otics successfully treat a range of bacterial rising costs, innovators often concentrate
infections, such as strep throat, ear infec- their efforts on products with potentially
tions, urinary tract infections, and pul- high market return. Developing counter-
monary infections. However, overconfi- measures and medicines targeted for impor-
dence in existing antibiotics, over-reliance tant public health needs (e.g., drug resist-
on them, disincentives for industry to devel- ance, counterterrorism), less common dis-
op new antibiotics (because a drug that takes eases, diseases prevalent in the developing
decades to develop might be useful clinically world, or individualized therapy is becoming
for only a few years), lack of sufficient diag- increasingly challenging.100 That is why addi-
nostic tools, and competition from more tional incentives may be necessary to foster
highly profitable opportunities for pharma- the development of treatment medications
ceutical development and sale of medicines for those diseases that do not represent large
to treat chronic diseases, has resulted in a lag market opportunities but have high rates of
in the production of new classes of antibi- morbidity and mortality. The threat of cer-
otics. According to the Infectious Diseases tain drug resistance and viruses as agents of
Society of America, “the end result of the biological terrorism emphasizes the
decline in antibiotic discovery research is increased need for the development of new
that U.S. Food and Drug Administration counter-measures, as well as broad-spectrum
(FDA) is approving few new antibiotics. antibiotics, antivirals, and immunomodula-
Since 1998, only 12 new antibiotics have tors, especially for those agents for which
been approved, 2 of which are truly novel there are no vaccines.101
(i.e., defined as having a new target of

18
Vaccines
The success of vaccines in preventing infec- production methods and a pricing structure
tious diseases has been profound. The that may not adequately compensate indus-
childhood diseases of diphtheria, tetanus, try for development costs in the years imme-
and polio are relatively rare in the devel- diately following licensure.102
oped world and are controlled in many
Cultural obstacles, religious and ethical con-
developing countries. Smallpox, one of the
cerns, and misinformation about the safety
most horrific killers in human history, was
and efficacy of vaccines can impact market
eradicated through the employment of an
size and increase the likelihood of vaccine-
effective vaccine. However, despite some
preventable diseases in those who are not
progress and the dedication of scientists
immunized. For example, of the 95 patients
worldwide, there still are no highly effective
who contracted measles during the 2008
vaccines available to prevent 3 of the world’s
outbreak in the U.S. and were eligible for
largest killers: HIV/AIDS, TB, and malaria.
vaccination (over 12 months of age), 63
And, a large proportion of the world’s chil-
were unvaccinated because of their or their
dren do not have access to currently-avail-
parents’ philosophical or religious beliefs.103
able, highly effective vaccines.
The U.S. must continue to modernize its
As science and medicine progress, sometimes
approach to vaccine production and delivery,
at lightening speed, opportunities for major
increase domestic capacity to manufacture
breakthroughs in vaccine development are
vaccines, and recognize that it has a responsi-
very promising. Scientists have made signifi-
bility to help assure that all the people of the
cant advances in genomics, immunology, and
world have access to vaccines. This is both a
biotechnology, including discoveries in
moral responsibility and a practical necessity;
reverse genetics methods for faster develop-
in a highly interdependent world, mitigating
ment of influenza vaccines and for new vac-
the impact of any infectious disease pandem-
cines such as Gardasil and Cervarix, which
ic requires that all corners of the globe are
protect against certain types of the human
protected equally. As part of this effort, the
papillomavirus (HPV) infection that can cause
U.S. government must coordinate activities
cervical cancer in girls and young women.
between the public and private sectors, and
Vaccine development and production is with academia. To effectively harness the sci-
complex and is dictated by a set of variables, entific expertise potentially available for this
including the translation of basic research endeavor, vaccine development and modern-
into the development of effective vaccines, ization efforts must be open and transparent
regulatory requirements, liability concerns, to ensure that experts from government,
and market forces, which include market industry, and academia from around the
disincentives for developing new vaccine world have access to vital information.

New Technology
Geographers are contributing to the fight surface temperature patterns in the Indian
against emerging infectious diseases by and Pacific oceans, scientists now believe
turning satellite imaging and global posi- they have found a way to predict outbreaks
tioning systems into tools to help prevent up to 5 months in advance. By predicting
infection. In the early 2000s, scientists pre- the likely onset of an outbreak, the geogra-
dicted an outbreak of the mosquito-borne phers prompted local public health officials
Rift Valley fever in Kenya by using these to implement prevention strategies.104
devices. Scientists at the Goddard Earth
Hantavirus outbreaks in the U.S. Southwest
Sciences and Technology Center and at the
could also be monitored in this way. The virus
Walter Reed Army Institute of Research
is carried by deer mice and can kill people
have discovered that outbreaks of Rift Valley
who have been exposed to it. Like Rift Valley
fever follow sudden floods triggered by El
fever, Hantavirus is correlated with rainfall, so
Niño and a similar (yet lesser-known) cli-
the same kind of bioclimatic rhythms can be
mate disturbance called the “Indian Ocean
used to predict an outbreak.105
Dipole.” Using weather satellites to track sea

19
 5. FINANCIAL INCENTIVES ARE CRITICAL
If the demand for new diagnostics, therapeu- date drugs. But these are still few for each
tics and vaccines to combat emerging infec- disease, and success may rest on the fate of
tions is so urgent, why has industry not one or 2 products. New types of products
answered the call? The answer requires a clos- also require new delivery systems (e.g., “gene
er look at market forces and business strategy. gun” system for administering DNA vac-
cines) and new production systems (e.g.,
The development of new medical technolo-
cell-based production systems for influenza
gies is a long and expensive process.
vaccine) that carry their own development
Pharmaceutical industry standards for new
risks and costs. Finally, many emerging dis-
drug development are a good example.
eases are currently uncommon in the U.S. or
These standards predict, on average, a 10-year
are treated with short-course therapy, thus
development period from drug discovery to
creating a small market for their sales.
licensure at a price tag around $1 billion.106 A
significant proportion of the time and fund- When a large pharmaceutical or biotechnolo-
ing required comes in advanced develop- gy company is faced with the choice of pursu-
ment. In addition, the expected failure rate is ing a new drug for TB or the next multi-billion
high; only 10 percent of candidate drugs in dollar statin, shareholders are much less inter-
Phase I trials ever make it to licensure.107 ested in altruism than in a wise investment
that minimizes opportunity costs. As a result,
In order to maintain profitability in a highly
a significant proportion of product develop-
competitive market, pharmaceutical and
ment for biodefense or emerging infectious
biotechnology companies must minimize
diseases rests with small companies. Many of
the risk of development while maximizing
these are supported by venture capital, and
the reward (profit) potential for products.
they lack institutional experience of carrying a
Risk is minimized by spreading it among
product from discovery to licensure.
multiple drug candidates, pursuing class
analogs similar to already successful prod- Advocates, policymakers, pharmaceutical
ucts, and utilizing existing and proven sys- companies, and researchers debate ways in
tems for developing and manufacturing. which research and development of vaccines,
Reward is maximized by targeting diseases treatments and diagnostic tools can be accel-
with proven high returns. Generally drugs erated, but most agree that a combination of
treating chronic and highly prevalent dis- initiatives is needed to fight emerging infec-
eases create the best sales opportunities. tious diseases. No one-size-fits-all approach
will spur adequate investment in biomedical
Unfortunately, most countermeasures for
research and development on emerging
emerging infectious diseases present an
infectious diseases. Different medications,
unfavorable risk-reward balance for industry.
vaccines, diagnostic tools, and surveillance
NIAID funding has strengthened the aca-
systems have different market potential and
demic research base for emerging infectious
require varying levels of up-front investment.
diseases and has produced promising candi-

Public-Private Partnerships
Public-private partnerships are proving to strains, be compatible with antiretroviral
be effective in the search for new vaccines therapies for those HIV-TB patients current-
and drugs. Treatments for dengue fever, ly on such therapies, and improve treatment
malaria, and MDR-TB are under develop- of latent infection.109 The GAVI Alliance’s
ment through the Novartis Institute for (formerly the Global Alliance for Vaccines)
Tropical Diseases, a public-private partner- Accelerated Development and Introduction
ship involving the Swiss-based Novartis phar- Plans (ADIPs) have promoted research and
maceutical company and the Singapore “negotiation with the pharmaceutical and
Economic Development Board.108 Working public health sectors to achieve rapid, suc-
with public and private research laborato- cessful introduction of the pneumococcal
ries worldwide, the Global Alliance for TB and rotavirus vaccines.”110 Proponents of
Drug Development is committed to acceler- public-private partnership urge greater sup-
ating the discovery and development of new port of initiatives that involve small-scale
TB drugs that will shorten treatment, be commercial endeavors.
effective against susceptible and resistant
20
A massive infusion of philanthropic funds is Global Fund to Fight AIDS, Malaria and
also stimulating investment in research and Tuberculosis. Former President Bill Clinton is
development for vaccines and medicines, pro- supporting the Sabin Vaccine Institute’s “Stop
fessional training, and public education Neglected Tropical Disease Campaign.”111
efforts. The Bill and Melinda Gates British Prime Minister Gordon Brown recent-
Foundation is spearheading large global ly committed his nation to buying 20 million
health initiatives, including support for the mosquito nets for malaria-ravaged nations.

U.S. Government Programs to Spur Investment

The U.S. government has several measures may be able to take advantage of existing pro-
already in place to encourage private sector grams that are well established. For instance,
investment for the development of vaccines, the far-reaching global HIV vaccine trial infra-
medicines and diagnostics. In addition to the structure may be a useful model for testing
specific measures described below, researchers tuberculosis treatments or vaccines.

Orphan Drug Act

The Orphan Drug Act (P.L. 97-414, as amend- For the purposes of the Act, an “orphan
ed) includes various incentives that have stim- drug” is one that would treat or prevent a rare
ulated a considerable amount of interest in disease or condition that affects fewer than
the development of orphan drug and biolog- 200,000 persons in the U.S., or that may affect
ical products. The incentives include tax more than 200,000 persons in the U.S., but
credits for clinical research undertaken by a for which there is no reasonable expectation
sponsor to generate required data for mar- that the cost of developing and producing the
keting approval, and 7 years of marketing drug would be recovered from its U.S. sales.112
exclusivity for a designated drug or biological
product approved by FDA.

Project BioShield and BARDA

In 2004, Congress passed the Project fessionals are working together to meet the
BioShield Act to jump-start the nation’s abili- threat of bioterrorism -- we’re making the
ty to develop, purchase, and deploy cutting- American people more secure.”113
edge countermeasures against a bioterrorism
In 2006, Congress enacted the Pandemic and
attack. The law also granted the federal gov-
All-Hazards Preparedness Act (PAHPA), which
ernment new authority to expedite research
in part, directed HHS to establish the Biomed-
and development on the most promising and
ical Advanced Research and Development
time-sensitive medicines to defend against
Authority, or BARDA, and authorized funding
bioterror. Congress authorized $5.6 billion
of advanced development of medical counter-
for Project BioShield over 10 years so that the
measures, such as vaccines, drugs, and diag-
government could purchase and stockpile
nostic tools for public health emergencies
vaccines and drugs to fight anthrax, small-
affecting national security.114
pox, and other potential agents of bioterror.
However, funding for Project BioShield has BARDA is the umbrella organization within
been significantly lower than the level the Office of the Assistant Secretary for
authorized. For example, the program was Preparedness and Response at HHS that pro-
authorized at $1.07 billion for Fiscal Years vides an integrated, systematic approach to
2006-08, but received an appropriation of the development and purchase of the med-
only $102 million in Fiscal Year 2008. ical countermeasures, treatments, and diag-
nostic tools for public health medical emer-
In signing the bill into law, President Bush
gencies. Upon its creation, BARDA assumed
acknowledged the vital role that the private
responsibility for 2 existing separate, but
sector plays in biodefense efforts by taking
complementary projects: The Public Health
risks to bring new treatments to the market.
Emergency Medical Countermeasures Enter-
He said, “By acting as a willing buyer for the
prise (PHEMCE) and Project BioShield.
best new medical technologies, the govern-
ment ensures that our drug stockpile There is some expectation among
remains safe, effective, and advanced. The researchers and government officials that
federal government and our medical pro- the establishment of BARDA and its over-
21
 sight of Project BioShield may improve the such a dedicated mechanism could allow
chances of success during the development countermeasures to further mature through
phase of countermeasures. According to the development process longer before
the Congressional Research Service, “one of competing for a Project BioShield contract.
BARDA’s roles is to support the advanced This could reduce the risk that a counter-
research and development of promising measure will fail while under a Project
countermeasures. In theory, funding this BioShield contract.”115
part of the development process through

Priority Review Voucher for Neglected Tropical Diseases

In September 2007, Congress approved an owner of the voucher can sell it to another
amendment sponsored by Senators Sam company on the open market.117 New drugs
Brownback (R-KS) and Sherrod Brown (D- or treatments for neglected tropical diseases
OH) to the Food and Drug Administration may also qualify for market exclusivity and
Revitalization Act, which created a transfer- tax credits under the Orphan Drug Act.
able voucher to “encourage treatments for
Unlike many other incentive mechanisms,
tropical diseases.”116 The amendment allows
the voucher program does not require any
the sponsor of a newly approved drug or
up-front financial outlays by governments or
vaccine, which prevents or treats an eligible
donors, and no budgetary provisions are
tropical or neglected disease, to receive a
required. However, some worry that while
priority review voucher, which can then be
developing new drugs and treatments is a cru-
applied to another product.
cial step to alleviating the burden of tropical
Priority review reduces the time it takes FDA diseases, the voucher program does not guar-
to assess a product submitted for approval antee that producers will make new treat-
from an average of 18 months to “no ments available in sufficient quantities or at
longer” than 6 months. The company prices that will be affordable to individuals.118
obtaining the voucher can use it for anoth- Vouchers, which are not universally support-
er human drug submission, affording an ed by medical experts or the pharmaceutical
opportunity to get that product to market industry, could be worth as much as $500 mil-
many months sooner. Alternatively, the lion according to some estimates.119

Strategies to Address Antimicrobial Resistance (STAAR) Act

Introduced in 2007 by Senators Sherrod HHS agencies as well as across multiple fed-
Brown (D-OH) and Orrin Hatch (R-UT) eral departments, including Agriculture,
and Representatives Jim Matheson (D-UT) Veterans Affairs, Labor, and Defense, as well
and Michael Ferguson (R-NJ), the STAAR as the Environmental Protection Agency.
Act is designed to enhance the U.S. ability to
The STAAR Act would also provide new
respond to the antimicrobial resistance
opportunities to address the global antimi-
problem. The bill would provide compre-
crobial resistance problem. The STAAR Act
hensive strategies to strengthen federal
includes a comprehensive set of specific
antimicrobial resistance surveillance, pre-
actions to avoid a public health crisis that is
vention and control, and research efforts.
taking and/or debilitating the lives of hun-
The legislation would authorize new fund-
dreds of thousands of Americans annually.120
ing and strengthen coordination within

22
6. RECOMMENDATIONS
The magnitude and urgency of addressing ration, and coordination with industry, aca-
emerging and resurging diseases demand demia, private organizations, and founda-
renewed attention, dedication, and sus- tions. Additional investments should take
tained resources to ensure the health and the form of financial and technical assis-
safety of the nation and of the world. tance, operational research, enhanced sur-
veillance, and efforts to share both knowl-
U.S. policy makers must abandon a point of
edge and best public health practices across
view that emerging infectious diseases in the
national boundaries. The U.S. should exert
developing world are a back-burner con-
its leadership in setting global goals for
cern for Americans. And the nation’s com-
elimination or eradication of diseases where
mitment to eliminating these diseases, or
this is possible, such as malaria and tubercu-
mitigating their impact on global mortality
losis. In addition, the President should
and morbidity, can no longer be based on
appoint a distinguished public health offi-
international goodwill alone. Emerging and
cial to a new high-level position responsible
re-emerging diseases, especially those relat-
for coordinating the U.S. effort and for serv-
ed to potential bioterror threats, are a mat-
ing as a point of contact for public, private,
ter of national security.
and public-private efforts.
Trust for America’s Health (TFAH) recom-
mends the following actions, many of which 3. The U.S. should enhance its leadership
mirror those made by the Board on Global role in promoting the implementation
Health and the IOM in their 2003 report, of a comprehensive system of surveil-
Microbial Threats to Health: Emergence, lance for global infectious diseases that
Detection, and Response.121 builds on the current global capacity of
infectious disease monitoring.
1. U.S. federal, state, and local govern- This multinational effort will require region-
ments should allocate the necessary al and global coordination, expertise, and
resources to build and sustain the financial resources from participating
nation’s public health capacity to nations. A comprehensive system is needed
respond to emerging diseases that are to accurately assess the burden of infectious
naturally occurring or intentional. diseases in developing countries, detect the
The nation’s public health capacity must be emergence of new threats, and direct pre-
enhanced to respond quickly to emerging vention and control efforts. Sustainable
disease threats and to monitor infectious progress in these efforts will require health
disease trends. Prevention and control agencies to broaden partnerships to include
capacity should be expanded at the local, philanthropic foundations and international
state, and national levels and be executed by institutions such as the World Bank and the
an adequately trained and competent work- United Nations. At the same time, infectious
force. Examples include enhancing surveil- disease surveillance systems in developed
lance (medical, veterinary, and entomologi- nations will require sustained investments to
cal [related to insects]); augmenting labora- strengthen their capacity and make them
tory facilities; building epidemiological, sta- more effective, accurate, and timely.
tistical, and communication skills among
the workforce; and implementing informa- 4. The U.S. government should develop a
tion and logistical systems to ensure the comprehensive, multi-year, government-
rapid utility and sharing of information wide research agenda for emerging infec-
among the public, industry, health care tious disease prevention and control in
facilities, and all levels of government. collaboration with state and local public
health partners, academia, and industry.
2. The U.S. should further its leadership This agenda should be designed to investi-
role in enhancing the global capacity to gate the role of genetic, biological, social,
respond, control, and eliminate infec- economic, political, ecological, and physical
tious disease threats. environmental factors in the emergence of
The U.S. should continue efforts to coordi- infectious diseases in the U.S. and through-
nate with key international agencies such as out the world. This agenda should also
WHO, with active communication, collabo- include the development and assessment of

23
 public health measures to address emerging longing the use of existing pesticides is
and re-emerging diseases, including the paramount in the absence of vaccines to
intentional use of biological agents. The prevent most vector-borne diseases.
research agenda should be flexible enough
to permit rapid assessment of new and 5. The U.S. government, professional
emerging threats, and should be rigorously health organizations, academia, health
reevaluated every 5 years to ensure that it is care delivery systems, and industry
addressing areas of highest priority. should expand efforts to decrease the
inappropriate use of antimicrobials in
Components of the research agenda should
human medicine, agriculture and
include:
aquaculture through:
I A national vaccine strategy for protecting I Expanded outreach and better education
the U.S. population from emerging and of health care providers, veterinarians,
re-emerging infectious diseases. The fed- drug dispensers, the food industry, and the
eral government should explore innova- general public on the inherent dangers
tive mechanisms, such as cooperative associated with the inappropriate use of
agreements between government and antimicrobials.
industry or consortia of government,
industry, and academia, to accelerate I Increased use of diagnostic tests, as well
research and development efforts. as the development and use of rapid
diagnostic tests, to determine the nature
I A national strategy for developing new of the infection and drug sensitivity,
antimicrobials, as well as producing an thereby ensuring a more appropriate use
adequate supply of approved antimicro- of antibiotics.
bials. This strategy should include plans
for stockpiling and distributing antibi- 6. The U.S. government should work
otics, antivirals, and antitoxins for natu- with academia, private organizations,
rally occurring or intentionally intro- and foundations to recruit, retain, and
duced disease threats. train public health professionals
I A national strategy to better understand the capable of identifying, verifying,
mechanisms of antibiotic resistance and to preventing, controlling, and treating
develop and evaluate interventions to pre- emerging infectious diseases.
vent and control resistance in human, ani- I Training should combine field and labo-
mal and agricultural environments. ratory approaches to infectious disease
prevention, diagnosis, and control.
I A national strategy for developing new
Federal agencies should develop these
rapid, cost-effective sensitive diagnostics
programs in close collaboration with state
to identify targeted pathogens, ensure
and local public health partners and aca-
appropriate use of existing antimicrobials
demic centers and should include an edu-
in the clinical setting, and reduce the cost
cational, hands-on experience at state
of clinical trials for new antimicrobials
and local public health departments.
thereby serving as an incentive for greater
industry research and development.
7. The U.S. government should support
Development of rapid, point-of-care diag-
intensified public health education
nostic tests for TB, including drug-resist-
efforts to prevent the spread of
ant TB; health care associated bacterial
infectious diseases.
infections; and various strains of the
influenza virus, should be priorities. I The U.S. should launch public education
campaigns on hand hygiene and cough eti-
I Research on innovative systems of surveil- quette, as well as the importance of com-
lance that capitalize on advances in health plying with the recommended schedule of
information technology. Integration of elec- childhood and adult vaccines, including
tronic medical records into public health seasonal influenza vaccines. Additionally,
surveillance systems should be pursued. disseminating information to the general
I Research on vector control. The develop- public about the appropriate use of antibi-
ment of safe and effective pesticides and otics should be a priority for the nation’s
repellents, as well as strategies for pro- public health departments.

24
8. The U.S. Congress should: investment in TB research could have a
I Amend the Orphan Drug Act to explicitly significant impact on disease control
address infectious diseases like MRSA, or and mitigation globally, including vac-
create a parallel incentive system to cine development.
address the unique concerns in this area. I Enhance appropriations for ongoing emer-
Specially tailored incentives are needed to ging infectious disease programs at NIH,
spur the development of new antimicro- CDC, DOD, the Department of Agriculture,
bials, vaccines, and diagnostics. and the Department of Homeland Security.
I Fully fund BARDA, which was authorized I Increase appropriations for global surveil-
at $1.07 billion for Fiscal Years 2006-08, lance efforts, including an increase in fund-
but was funded in Fiscal Year 2008 at ing to $45 million for the CDC’s Global
$102.1 million. Disease Detection program, which was
I Enact the Strategies to Address Antimicro- funded at $31 million in Fiscal Year 2008.
bial Resistance (STAAR) Act to strengthen I In light of the threat emerging and re-
the U.S. response to the increasing antimi- emerging diseases pose to Americans,
crobial resistance crisis through enhanced Congress should fully fund CDC’s pro-
coordination, leadership, research, pre- grams to support state and local public
vention and control, and surveillance. health departments’ all-hazards pre-
I Request a professional judgment budget paredness activities. At a minimum, fund-
for a comprehensive, multi-year, govern- ing should be restored to the Fiscal Year
ment-wide research agenda for emerg- 2005 level of $919 million. In Fiscal Year
ing infectious disease prevention and 2008, programs to upgrade the capacity
control and fully fund it. For example, of state and local public health depart-
according to the professional judgment ments were funded at $746 million.
of senior NIH researchers, a $50 million

Colorized transmission electron

micrograph of Avian influenza A
H5N1 viruses (seen in gold)
grown in MDCK cells (seen in
green).

25
 APPENDIX A: THE WORLD’S DEADLIEST
INFECTIOUS DISEASES
Many of the global efforts to reduce the bur- lion or more illnesses a year and at least 6 mil-
den of infectious diseases are concentrated on lion deaths.122 Also, hepatitis C (HCV) infec-
HIV/AIDS, TB, and malaria. Combined, these tions are pervasive worldwide -- an estimated
3 diseases account for approximately 500 mil- 200 million people have the virus.

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency

Syndrome (AIDS)
AIDS is a chronic, life-threatening condition for stemming the spread of HIV is to focus
caused by the human immunodeficiency on prevention, treatment, and education.
virus (HIV). By damaging or destroying the
The U.S. commitment to the global battle
cells of the body’s immune system, HIV
against HIV/AIDS has been impressive. In
interferes with the ability to effectively fight
2003, President Bush launched the
off viruses, bacteria, and fungi that cause
President’s Emergency Plan for AIDS Relief
disease. This makes individuals with HIV
(PEPFAR), committing $15 billion over 5
more susceptible to certain types of cancers
years to combat global HIV/AIDS -- the
and to opportunistic infections that the
largest international health initiative in his-
body would normally resist, such as pneu-
tory to fight a single disease. In July 2008,
monia, TB, and meningitis.123 The virus
the U.S. Congress reauthorized PEPFAR
itself is known as HIV. The term acquired
and increased its funding level to $39 billion
immunodeficiency syndrome (AIDS) is used
over the next 5 years.126 In addition, the new
to mean the later stages of an HIV infection.
law provides funding to fight the diseases
An individual can become infected with that complicate HIV/AIDS. It commits $4
HIV in several ways, including unprotected billion to fight tuberculosis -- which is the
sex; transfusion of infected blood; transmis- leading killer of Africans living with HIV --
sion through needle sharing or accidental and pledges an additional $5 billion to com-
needle sticks; re-use of syringes in a medical bat malaria.
setting, especially where the medical infra-
According to the White House, PEPFAR has
structure is lacking; or transmission from
already helped bring life-saving treatments to
mother to child during pregnancy, delivery,
millions of people worldwide. For example,
or through breast feeding. In rare cases, the
at of the end of Fiscal Year 2007, PEPFAR was
virus may be transmitted through organ or
supporting life-saving antiretroviral treat-
tissue transplants or unsterilized dental or
ment for approximately 1.7 million people
surgical equipment.124
living with HIV/AIDS in the 15 focus coun-
In the nearly 3 decades since the first tries in Sub-Saharan Africa, Asia, and the
reports of the disease, AIDS has become a Caribbean. When the President announced
global pandemic. Worldwide, an estimated PEPFAR in 2003, only 50,000 people in all of
38.6 million people are living with HIV, sub-Saharan Africa were receiving treatment.
nearly half of them women and girls PEPFAR has also supported treatment and
between the ages of 15 and 24. And though care for nearly 7 million people, including
the spread of the virus has slowed in some millions of orphans and vulnerable children.
countries, it has escalated or remained At the signing of the PEPFAR reauthoriza-
steady in others. In 2007, more than 2.7 mil- tion, President Bush observed that the initia-
lion people were newly infected with HIV; tive had allowed nearly 200,000 children in
25 million have died of AIDS since the pan- Africa to be born HIV-free.127
demic began, 2 million in 2007 alone.125
There are 1.2 million people living with
Despite improved treatments and better HIV/AIDS in the U.S., including more than
access to care for people in the hardest-hit 440,000 with AIDS.128 There are an estimat-
parts of the world, most experts agree that ed 56,300 new cases of HIV diagnosed in
the pandemic is still in the early stages. With this country every year.129 Nearly 566,000
a vaccine probably years away, the best hope Americans have died of AIDS since 1981.130

26
Hepatitis C (HCV)
Hepatitis C is a contagious liver disease that I Sharing needles, syringes, or other equip-
ranges in severity from a mild illness lasting a ment to inject drugs.
few weeks to a serious, lifelong illness. It results
I Exposure to needle stick injuries in
from infection with the hepatitis C virus
healthcare settings.
(HCV), which is spread primarily through
contact with the blood of an infected person. I Exposure to unclean tattooing or body-
Hepatitis C can be either “acute” or “chronic.” piercing instruments.
Acute hepatitis C virus infection is a short- I Being born to a mother who has hepatitis C.
term illness that occurs within the first 6
Less commonly, a person can also get hepa-
months after someone is exposed to the hep-
titis C virus infection through:
atitis C virus. Approximately 75 to 85 percent
of people who become infected with hepati- I Sharing personal care items that may have
tis C virus develop chronic infection. come in contact with another person’s
blood, such as razors or toothbrushes.
Chronic hepatitis C virus infection is a long-
term illness that occurs when the hepatitis C I Having sexual contact with a person
virus remains in a person’s body. HCV can infected with the hepatitis C virus.131
last a lifetime and lead to serious liver prob-
Globally, 200 million people, or more than 3
lems, including cirrhosis (scarring of the
percent of the world’s population are infect-
liver) or liver cancer.
ed with HCV.132 CDC estimates that 3.2 mil-
People can become infected with the hepa- lion Americans have chronic HCV infection,
titis C virus by: and approximately 10,000 die each year
from HCV liver disease.133

Malaria
Although malaria has been virtually elimi- A malaria infection is generally character-
nated in developed nations with temperate ized by recurrent attacks, each of which has
climates, it is still prevalent in tropical and 3 stages -- chills, followed by fever, and then
subtropical countries in Africa, Asia, the sweating. Along with chills, the person is
Middle East, South America, and Central likely to have headache, malaise, fatigue,
America. Evolving strains of drug-resistant muscular pains, occasional nausea, vomit-
parasites and insecticide-resistant mosqui- ing, and diarrhea. Within an hour or 2 of
toes continue to make this emerging infec- the initial symptoms, the body temperature
tious disease a global health threat. rises, and the skin feels hot and dry.
Subsequently, as the body temperature falls,
Malaria is caused by a single-celled parasite
a drenching sweat begins.135
from the genus Plasmodium and is typically
transmitted to humans by mosquitoes. Malaria Doctors can treat malaria effectively with
can also be transmitted through blood trans- several medications, which are known col-
fusions, organ transplants, or contaminated lectively as “antimalarial drugs.” However,
needles or syringes. “Congenital” malaria there is increasing worry about drug-resist-
refers to the transmission from a mother to ant parasites that have rendered some of
her fetus before or during childbirth.134 these medicines ineffective.

QUICK FACTS ON MALARIA

I More than 40 percent of the world’s pop- I Approximately 300-500 million cases of
ulation lives in areas where there is a risk clinical malaria occur each year.
of contracting malaria.
I Malaria accounts for at least $12 billion in
I A child dies of malaria every 30 seconds. economic losses each year in Africa, and a
reduction in annual economic growth esti-
I More than one million people die of malaria
mated at 1.3 percent.
every year, mostly infants, young children, and
pregnant women; most of them live in Africa. Source: World Health Organization

27
 Tuberculosis (TB)
Tuberculosis has plagued mankind for cen- People with weakened or compromised
turies. Today, despite advances in treatment, immune systems - - individuals with HIV dis-
TB is a global pandemic, fueled by the ease, those receiving chemotherapy, preg-
spread of HIV/AIDS, poverty, a lack of nant women - - are at a much greater risk for
health services, and the emergence of drug- developing active TB disease. When these
resistant strains of the bacterium that causes people breathe in TB bacteria, the bacteria
the disease.136 settle in the lungs and start growing because
the individual’s immune system cannot fight
Every year, about 9 million people develop
the bacteria. In these people, TB disease
active TB disease, and TB kills nearly 2 mil-
may develop within days or weeks after the
lion people worldwide. The infection is
infection. In 2006, CDC reported 9,842
common - - about one-third of the human
cases of active TB in the U.S.141
population is infected with TB, with one
new infection occurring every second.137 The most common method for detecting
TB infection is a tuberculin skin test, which
TB is a contagious airborne disease caused
is performed by injecting a small amount of
by infection with Mycobacterium tuberculosis.
tuberculin antigen under the skin in the
TB typically affects the lungs; however it also
lower part of the arm. A person given the
may affect any other organ of the body, such
tuberculin skin test must return within 48 to
as the brain, the kidneys, or the spine.
72 hours to have a trained health care pro-
There is a difference between latent TB fessional look for a reaction on the arm. A
infection and active TB disease, which positive tuberculin skin test only indicates
makes people sick and can be spread to oth- that a person has been infected with TB
ers. One-third of the world’s population has germs. It does not confirm that the individ-
the TB bacterium in their bodies, and they ual has progressed to active TB disease. The
are considered to have a TB infection. presence of symptoms and additional tests,
Those who do not get sick are known to such as a chest x-ray and a sample of spu-
have latent TB infection, which is not conta- tum, are needed to determine whether the
gious. TB bacteria can remain in this dor- individual has active TB disease.142
mant state for months, years, and even
TB disease usually can be cured with prompt
decades without increasing in number and
and appropriate treatment, but it remains a
without making the person sick. Most peo-
major cause of death and disability in the
ple with latent TB infection will test positive
world. It is usually treated with a regimen of
on the tuberculin skin test, or their chest X-
drugs taken for 6 months to 2 years depend-
ray will show signs of latent TB, but will not
ing on the type of infection. It is imperative
develop active TB disease, may never get
that people who have TB disease finish the
sick, may never show any symptoms, and
medicine, and take the drugs exactly as pre-
may never spread the bacteria to others.138
scribed. If they stop taking the drugs too
However, approximately one in 10 people soon or do not take the drugs correctly, they
infected with TB bacteria develop active TB can become ill again and the infection may
disease. When an individual develops active become more drug resistant.143
TB, it means the TB bacteria are multiplying
Public health officials are particularly con-
and attacking the lung(s) or other parts of
cerned about 2 forms of TB disease that are
the body. Symptoms of active disease include
drug resistant. According to NIAID, mul-
cough, loss of weight and appetite, fever,
tidrug-Resistant Tuberculosis (MDR-TB) is a
chills, and night sweats as well as symptoms
form of drug-resistant TB in which the TB bac-
from the specific organ or system that is
teria can no longer be killed by at least the 2
affected; for example, coughing up blood or
best antibiotics, isoniazid (INH) and rifampin
sputum in TB of the lungs or bone pain if the
(RIF), commonly used to cure TB. As a result,
bacteria have invaded the bones.139 TB germs
this form of the disease is more difficult to treat
spread when a person infected with active TB
than ordinary TB and requires up to 2 years of
disease in the lungs or throat coughs or
multidrug treatment. Extensively drug-resist-
sneezes.140 People with active TB disease are
ant tuberculosis (XDR-TB) is a less common
most likely to spread it to people they spend
form of multidrug-resistant TB in which the
time with every day. This includes family
TB bacteria have changed enough to circum-
members, friends, and coworkers.

28
vent not only INH and RIF, but also most of the Susceptibility testing for TB is time-consum-
alternative drugs used against MDR-TB. These ing, resource-intensive, and not well-validat-
second-line drugs include any fluoro- ed. Few laboratories are able to conduct the
quinolone, and at least one of the other 3 tests, which dramatically complicates the
injectable anti-TB drugs: amikacin, kanamycin, ability of public health officials to deter-
or capreomycin. As a result, XDR-TB generally mine whether a patient is infected with the
needs at least 2 years of extensive drug treat- standard variety TB, MDR-TB, or XDR-TB.
ment and is very challenging to treat.144

MILLENNIUM DECLARATION AND MILLENNIUM DEVELOPMENT GOALS

Since their adoption by 189 nations in September 2000, the Millennium Declaration and the
Millennium Development Goals (MDGs) have become a universal framework for develop-
ment and a means for developing countries and their development partners to work together
in pursuit of shared commitments to reduce poverty and hunger, and to tackle major health
issues, gender inequality, lack of education, lack of access to clean water and environmental
degradation. Together, the 8 MDGs represents a compact that recognizes the contribution
that developed countries can make through trade, development assistance, debt relief, access
to essential medicines, and technology transfer.
Goal 6 is directly related to infectious diseases. The following lists the targeted outcomes for
the goal and how progress will be measured.

GOAL 6: Combat HIV/AIDS, Malaria & Other Diseases

Target 6A: By 2015, halt and begin to reverse the spread of HIV/AIDS.
I HIV prevalence among population aged 15-24 years
I Condom use at last high-risk sexual encounter
I Proportion of population aged 15-24 years with comprehensive correct knowledge of
HIV/AIDS
I Ratio of school attendance of orphans to school attendance of non-orphans aged
10-14 years
Target 6B: Achieve, by 2010, universal access to treatment for HIV/AIDS for all
those who need it.
I Proportion of population with advanced HIV infection with access to antiretroviral drugs
Target 6C: By 2015, halt and begin to reverse the incidence of malaria and other
major diseases.
I Incidence and death rates associated with malaria
I Proportion of children under 5 sleeping under insecticide-treated bednets
I Proportion of children under 5 with fever who are treated with appropriate
anti-malarial drugs
I Incidence, prevalence, and death rates associated with tuberculosis
I Proportion of tuberculosis cases detected and cured under directly observed treatment
short course
Source: United Nations Development Programme.

29
 APPENDIX B: EMERGING INFECTIOUS DISEASE
THREATS TO THE U.S.
ANIMAL-BORNE DISEASES
Bolstering defenses against emerging human gence of zoonotic diseases worldwide can be
infections of animal origin, also known as attributed to population displacement,
zoonoses or zoonotic diseases, is crucial to urbanization and crowding, deforestation,
improving global public health. More than 35 of and globalization of the food supply.146
the most recent emerging diseases, including
The following are descriptions of emerging
H5N1 avian influenza, monkeypox, West Nile
or re-emerging zoonotic diseases that are
virus, and SARS, have been zoonotic in origin.145
endangering or may endanger the health of
The link between animal and human health Americans. CDC, NIAID, and WHO have
is not novel and has been studied for cen- thorough and accessible information on the
turies. In 1967, a landmark study undertaken symptoms, transmission, treatments (if any),
by the United Nation’s Food and Agriculture and epidemiology of these and many other
Organization and WHO documented more animal-borne diseases, including yellow
than 150 zoonotic diseases. By 2000, more fever, hantaviruses, Japanese encephalitis
than 200 diseases occurring in humans were virus, and rabies. Anthrax and SARS, which
known to be transmitted through animals. are described in earlier sections, also are
Experts believe that the increased emer- considered zoonotic diseases.

Avian Influenza in Humans

Most Americans have had some experience H5N1 virus mutates into a form that can
with seasonal influenza, a respiratory illness spread more easily from person to person. The
that strikes annually. Seasonal flu is not a grimmest scenario would be a global outbreak
benign illness -- it kills an average of 36,000 to rival the flu pandemic of 1918 and 1919,
and hospitalizes over 200,000 people in the which claimed millions of lives worldwide.
U.S. every year.147 Most experts generally
Because the H5N1 virus does not commonly
regard it as a manageable public health
infect humans, there is little or no immune
problem, since many people have some
protection against it in the human population.
form of immunity, and a new vaccine is avail-
At present, 2 antiviral medicines used to treat
able each year.
seasonal influenza -- oseltamivir (Tamiflu) and
Fears about pandemic influenza have intensi- zanamivir (Relenza) -- may be treatment
fied in recent years with the emergence of a options should an H5N1 or another influenza
deadly strain of avian (bird) influenza. Avian virus spark a pandemic.150 However, there
influenza is an infection caused by avian remains uncertainty about their utility in a
influenza (flu) viruses. One such virus, influen- pandemic: Access may be limited, resistance
za A, subtype H5N1, has scientists and public may develop, and additional barriers may pre-
health officials especially concerned. H5N1 vent the rapid administration after the onset
originated in Asia, but has spread through of symptoms necessary for optimal benefit.
Europe, Africa, and the Middle East, with cases
In April 2007, FDA approved the first human
in birds reported as far north as England and
vaccine to prevent infection from one strain of
human cases reported as far south as Nigeria.
H5N1 bird flu virus. This vaccine is not avail-
H5N1 has led to the deaths of hundreds of able to the public, but the U.S. government is
millions of wild and domestic birds and as of stockpiling it and may distribute it if it is close-
August 15, 2008, 243 human fatalities.148 ly matched to the influenza virus that sparks
Currently, however, bird flu remains diffi- the next pandemic. Additional research and
cult for humans to contract. Most people clinical trials are being supported by NIAID
who have developed symptoms have had and vaccine manufacturers, including studies
close contact with sick birds, though in a few on the use of an adjuvant -- something that
cases, bird flu has been transmitted from helps a vaccine provoke stronger immunity in
one person to another.149 the human body -- in candidate H5N1 vac-
cines.151 Adjuvants also are important because
Health officials are concerned that a major
they can extend the available vaccine supply.
bird flu outbreak could occur in humans if the
30
H5N1 viruses, however, are not the only viruses and avian H7N2, H7N3, and H9N2,
pandemic influenza threat. Other influenza highlighting the need for continued vigi-
A viruses that have jumped from animals to lance in monitoring for influenza viruses
cause illness in people include swine H1N1 with the potential to cause a pandemic.

Lyme Disease
Lyme disease (borreliosis) is the most prevalent system. About 10 to 20 percent of untreated
tick-borne infectious disease in the U.S. The people develop chronic arthritis.155
disease is caused by a spiral-shaped bacteri-
Lyme disease can also affect the nervous sys-
um, Borrelia burgdorferi, and transmitted to
tem, causing such symptoms as stiff neck, Bell’s
humans by the bite of the black-legged tick.
palsy, and numbness in the limbs. Less com-
Typical symptoms include fever, headache,
monly, untreated people can develop heart
fatigue, and a characteristic skin rash. The
problems, hepatitis, and severe fatigue.156
telltale rash starts as a small red spot at the site
of the tick bite and expands over time, form- According to CDC, in 2006, there were 19,931
ing a circular or oval-shaped rash. cases of Lyme disease reported in the U.S., yield-
ing a national average of 8.2 cases per 100,000
As infection spreads, rashes can appear at
persons. In the 10 states where Lyme disease is
different sites on the body. It is often accom-
most common, the average was 30.2 cases per
panied by symptoms such as fever,
100,000 persons.157 The disease continues to
headache, stiff neck, body aches, and
spread geographically and increases in intensity
fatigue. If left untreated, infection can
in areas in which it had already been found.
spread to joints, the heart, and the nervous

Rift Valley Fever

Rift Valley Fever (RVF) is a serious, fever- tissues of infected animals. Individuals with
causing viral disease that affects domestic RVF typically have either no symptoms or a
animals (such as cattle, buffalo, sheep, and mild illness associated with fever and liver
goats) and humans. RVF is most commonly abnormalities. Patients who develop symp-
associated with mosquito-borne epidemics toms usually experience fever, generalized
during periods of unusually heavy rainfall. weakness, back pain, dizziness, and extreme
Generally found in regions of eastern and weight loss at the onset of the illness. However,
southern Africa where sheep and cattle are in some patients the illness can progress to
raised, a RVF outbreak was reported in Saudi hemorrhagic fever (which can lead to shock
Arabia in 2000 and subsequently in Yemen. or hemorrhage), encephalitis (inflammation
of the brain, which can lead to headaches,
Bites from infected mosquitoes are generally
coma, or seizures), or ocular disease (includ-
the means of transmission of RVF to humans,
ing blindness). Typically, patients recover with-
although people can also get the disease if
in 2 days to one week after onset of illness.158
they are exposed to the blood, body fluids, or

This is a transmission electron

micrograph (TEM) of the West
Nile virus (WNV).

31
 West Nile Virus
West Nile Virus (WNV) first emerged in the mation of the brain and spinal cord.159 In
Western Hemisphere in 1999 in the New 2007, CDC reported 3,630 cases of WNV in
York City area and spread rapidly through- the U.S. and 124 deaths from the disease.160
out the U.S. The virus is transmitted to
Licensed WNV vaccines exist for horses, but
humans by mosquitoes.
there are no specific vaccines or treatments
In general, most human infections are mild, for human WNV disease. According to
causing fever, headache, and body aches, NIAID, “Faced with a potentially deadly ill-
often accompanied by a skin rash and ness spreading quickly across the U.S., sci-
swollen lymph glands. If the virus crosses the entists and public health officials have accel-
blood-brain barrier, however, it can cause life- erated research on developing tools to pre-
threatening conditions that include inflam- vent and treat WNV disease.”161

THE ONE HEALTH INITIATIVE

The One Health Initiative, designed to foster greater collaboration between physicians and
veterinarians, is a direct response to increasing concerns about the threat of emerging dis-
eases worldwide and the significant threats such outbreaks pose to the health of humans and
domesticated animals.
Created in July 2007, a major goal of One Health is the integration of educational systems within
and among medical schools, veterinary schools, and schools of public health. The cross-disciplinary
project will promote increased research on cross-species disease transmission and the integration
of human, veterinary, and wildlife disease surveillance and control systems. The initiative also will
encourage comparative research on diseases affecting both humans and animals, including diabetes,
cancer, autoimmune disorders, and obesity.162

FOODBORNE ILLNESSES
Foodborne disease is caused by consuming have contaminated the food, for example, poi-
contaminated foods or beverages. According sonous mushrooms. These different diseases
to CDC, more than 250 different foodborne have various symptoms, and although they are
diseases have been identified.163 Most of these often referred to as “food poisoning,” there is
diseases are infections, caused by a variety of not a single “syndrome” that constitutes food-
bacteria, viruses, and parasites that can be borne illness. However, nausea, vomiting,
foodborne. Other diseases are poisonings, abdominal cramps, and diarrhea are common
caused by harmful toxins or chemicals that symptoms in many foodborne illnesses.164

Botulism
Botulinum toxins are the most poisonous sub- within 18 to 36 hours after eating contami-
stances known to humans. They are derived nated food, but can occur in as few as 6 hours
from bacteria called Clostridium botulinum. or as long as 10 days afterward.167
The toxins affect the nerves and, if untreated,
Of particular concern to public health officials
can cause paralysis and respiratory failure.
are ongoing attempts by a number of coun-
Exposure to the toxins can be fatal.165
tries to develop these toxins into bioweapons.
Foodborne botulism is caused by eating foods This poses a major threat because of its lethal-
that contain botulism toxin. Although deadly, ity and relative ease of production.
botulism is not contagious.166 Signs and symp-
A supply of antitoxin against botulism is main-
toms include difficulty swallowing or speak-
tained by CDC. The antitoxin is effective in
ing, facial weakness, double vision, trouble
reducing the severity of symptoms if adminis-
breathing, nausea, vomiting and abdominal
tered early in the course of the disease.168
cramps and paralysis. Symptoms usually begin

32
E. coli O157:H7
The Escherichia coli (E. coli) group of bacteria with E. coli infections develop a potentially life-
includes numerous strains and most are threatening complication known as hemolytic
harmless. However, in 1982, scientists identi- uremic syndrome (HUS). Symptoms include
fied the first harmful foodborne strain of E. decreased frequency of urination, extreme
coli in the U.S. -- O157:H7, which lives in the fatigue, and pallor. People with HUS should
intestines of ruminants, sheds in their feces, be hospitalized because their kidneys may stop
and is a leading cause of foodborne illness in working and they may develop other serious
this country. Most often, people are exposed problems. Most persons with HUS recover
to the E. coli bacteria through food or water, within a few weeks, but some suffer permanent
especially from undercooked ground beef damage or die.170
and contaminated raw vegetables or unpas-
For most people with an E. coli infection, the
teurized apple cider. In the U.S., about
best treatment option is to rest and drink
75,000 people each year become ill after
plenty of fluids to help with dehydration and
being infected with E. coli O157:H7.169
fatigue. People are advised to avoid taking
The main symptoms of E. coli O157:H7 are anti-diarrheal medications, which can slow
diarrhea, which may range from mild and the digestive system down, making it more
watery to severe and bloody, and abdominal difficult to get rid of the toxins. According to
cramping, pain, or tenderness. Some people CDC, antibiotics should not be used to treat
also may have a low-grade fever and others this infection. There is no evidence that treat-
experience nausea or vomiting. Approximately ment with antibiotics is helpful, and taking
5 to 10 percent of people who are diagnosed antibiotics may increase the risk of HUS.171

Salmonella
Salmonellosis, or Salmonella infection, is one avoid circulatory collapse. Life-threatening
of the most common bacterial infections of complications may also develop should the
the intestinal tract. Salmonella typically live in infection spread beyond the intestines. In
the intestines of animals and humans and most otherwise healthy people, diarrhea and
are shed through feces, where the bacteria abdominal pains subside within several days
remain highly contagious. Humans become to 2 weeks without specific treatment.
infected most frequently through the inges-
An antibiotic-resistant strain of S. typhimuri-
tion of contaminated food sources, such as
um, first found in the United Kingdom and
poultry, meat, raw dairy products, and chick-
then in the U.S., poses a major public health
en eggs. Salmonella can survive for months in
threat because it is resistant to several antibi-
water, ice, sewage, and frozen meat.172
otics normally used to treat people with
Typically, people with Salmonella infection Salmonella disease.174
develop diarrhea, fever and abdominal
Salmonella may occur in small, contained
cramps within 12 to 72 hours. Signs and
outbreaks in the general population or in
symptoms of Salmonella infection generally
large outbreaks in hospitals, restaurants, or
last 4 to 7 days. Most healthy people recover
institutions housing children or the elderly.
without specific treatment.173
Every year, CDC receives reports of 40,000
In some cases, diarrhea can cause severe fluid cases of Salmonellosis in the U.S.175
loss, requiring prompt medical attention to

33
 ENDNOTES 13 Lederberg, J., R. E. Shope, Oaks S.C., and the
Committee on Emerging Microbial Threats to
Health, Institute of Medicine, eds. Emerging
1 Berkelman, R.L., R.T. Bryan, M.T. Osterholm, Infections: Microbial Threats to Health in the United
J.W. LeDuc, J.M. Hughes. “Infectious Disease States. Washington, D.C.: The National
Surveillance: A Crumbling Foundation.” Science Academies Press, 1992.
264, no. 5157 (April 15, 1994): 369.
14 Ibid.
2 Gordon, D. National Intelligence Estimate 99-17D:
The Global Infectious Disease Threat and Its 15 U.S. Centers for Disease Control and
Implications for the United States. Washington, D.C.: Prevention. “Preventing Emerging Infectious
The National Intelligence Council, 2000. Diseases: A Strategy for the 21st Century --
http://www.fas.org/irp/threat/nie99-17d.htm Overview of the Updated CDC Plan.” Morbidity
(accessed May 18, 2008). and Mortality Weekly Report 47, no. RR-15
(September 11, 1998). http://www.cdc.gov/
3 Gordon, D. National Intelligence Estimate 99-17D: mmwr/PDF/rr/rr4715.pdf (accessed August
The Global Infectious Disease Threat and Its 4, 2008).
Implications for the United States. Washington, D.C.:
The National Intelligence Council, 2000. 16 UNAIDS. “2008 Report on the Global AIDS
http://www.fas.org/irp/threat/nie99-17d.htm Epidemic.” Joint United Nations Programme on
(accessed May 18, 2008). HIV/AIDS. http://data.unaids.org/pub/
GlobalReport/2008/jc1510_2008_global_repor
4 Trust for America’s Health. Ready or Not 2007: t_pp29_62_en.pdfIbid. (accessed July 30, 2008).
Protecting the Public’s Health from Diseases, Disasters,
and Bioterrorism. Washington, D.C.: Trust for 17 National Institute on Allergy and Infectious
America’s Health, 2007: 22. Diseases. “Emerging and Re-emerging infec-
tious Diseases.” U.S. Department of Health and
5 U.S. Food and Drug Administration. Human Services. http://www3.niaid.nih.gov/
Innovation/Stagnation: Challenge and Opportunity research/topics/emerging/list.htm (accessed
on the Critical Path to New Medical Product. June 11, 2008).
Washington, D.C.: U.S. Department of Health
and Human Services, March 2004. 18 Ibid.

6 Sencer, J.D. and N.W. Axnick. “Cost-Benefit 19 World Health Organization. “Outbreak News:
Analysis.” Presented at the International Yellow Fever, Brazil,” Weekly Epidemiological
Symposium on Vaccination against Commun- Record 83, no. 7 (February 15, 2008): 61.
icable Diseases, Monaco, March 14-17, 1973. http://www.who.int/wer/2008/wer8307.pdf

7 Satcher, David. “Eradication of Polio and 20 World Health Organization. “Malaria.”

Control or Elimination of Measles.” Testimony http://www.who.int/topics/malaria/en/
presented before the Senate Committee on (accessed June 11, 2008).
Appropriations, Subcommittee on Labor, Health 21 GlobalHealthFacts.com “TB.”
and Human Services, Education and Related http://www.globalhealthfacts.org/topic.jsp?i=1
Agencies, September 23, 1998. 7 (accessed June 11, 2008).
http://www.hhs.gov/asl/testify/t980923a.html
22 Ibid.
(accessed September 17, 2008).
23 National Institute of Allergy and Infectious
8 Brilliant, L.B. The management of smallpox eradi-
Diseases. “Tuberculosis (TB): Detailed
cation in India: A case study and analysis. Ann
Description of TB.” U.S. Department of Health
Arbor, University of Michigan Press, 1985: 10,
and Human Services.
15, 28, 311.
http://www3.niaid.nih.gov/topics/tuberculosis
9 U.S. General Accounting Office. Infectious /Understanding/description.htm (accessed
Diseases: Soundness of World Health Organization June 17, 2008).
Estimates for Eradication or Elimination.
24 U.S. Centers for Disease Control and Prevention.
Washington, D.C.: U.S. General Accounting
“Most U. S. Measles Cases Reported since 1996,
Office, April 1998. http://pdf.usaid.gov/
Many Unvaccinated because of Philosophical
pdf_docs/PCAAB126.pdf (accessed September
Beliefs.” U.S. Department of Health and Human
17, 2008).
Services. <http://www.cdc.gov/vaccines/vpd-
10 Scwartzman, Kevin, et. al. “Domestic Returns vac/measles/default.htm> (accessed August 21,
from Investment in the Control of 2008).
Tuberculosis in Other Countries.” New England
25 U.S. Centers for Disease Control and
Journal of Medicine 353, no. 10. (September 8,
Prevention. “Measles Update: Outbreaks Continue
2005): 1008-1018.
in U.S.” U.S Department of Health and Human
11 Ibid. Services. http://www.cdc.gov/Features/Measles
12 Ibid. Update/ (accessed July 14, 2008).

34
26 U.S. Centers for Disease Control and Preven- Diseases. “The History of Antimicrobial (Drug)
tion. “Bioterrorism Agents/Diseases by Resistance.” U.S. Department of Health and
Category.” U.S. Department of Health and Human Services. http://www3.niaid.nih.gov/
Human Services. topics/antimicrobialResistance/Understanding
http://www.emergency.cdc.gov/agent/agentlis /history.htm (accessed June 12, 2008).
t-category.asp (accessed July 18, 2008). 39 Henry, C. “Insurgents in the Bloodstream.”
27 Mayo Clinic. “Anthrax.” Proceedings 134, no 2. (February 2008).
http://www.mayoclinic.com/health/anthrax/D http://www.usni.org/magazines/proceedings/
S00422/DSECTION=1 (accessed June 16, 2008). archive/story.asp?STORY_ID=1354
28 U.S. Department of Defense. “Information 40 National Institute of Allergy and Infectious
Paper: Anthrax as a Biological Warfare Agent.” Diseases. “Antimicrobial (Drug) Resistance: A
http://www.defenselink.mil/other_info/agent. Growing Health Issue.” U.S. Department of
html (accessed August 1, 2008). Health and Human Services.
29 National Institute of Allergy and Infectious http://www3.niaid.nih.gov/topics/antimicrobi
Diseases. “Anthrax: Cause.” U.S. Department of alResistance/Understanding/healthIssue.htm
Health and Human Services. (accessed June 12, 2008).
http://www3.niaid.nih.gov/healthscience/heal 41 Mayo Clinic. “MRSA Infection.”
thtopics/anthrax/prevention.htm (accessed http://www.mayoclinic.com/health/mrsa/DS0
June 16, 2008). 0735/DSECTION=8 (accessed June 16, 2008).
30 Kissinger, H. National Security Decision 42 Ibid.
Memorandum 35: United States Policy on Chemical 43 Ibid.
Warfare Program and Bacteriological/Biological
Research Program. Washington, D.C.: National 44 Ibid
Security Council, November 15, 1969. 45 Tillotson, G.S., D.C. Draghi, D.F. Sahm, K.M.
(Declassified on September 10, 1977). Tomfohrde, T. del Fabro, and I.A. Critchley.
31 National Institute of Allergy and Infectious “Susceptibility of Staphylococcus aureus
Diseases. “Smallpox: Overview.” U.S. Isolated from Skin and Wound Infections in
Department of Health and Human Services. the United States 2005-07: Laboratory-based
http://www3.niaid.nih.gov/healthscience/heal Surveillance Study.” Journal of Antimicrobial
thtopics/smallpox/overview.htm (accessed Chemotherapy 62, no. 1. (July 2008): 109-15.
June 17, 2008). http://jac.oxfordjournals.org/cgi/content/sho
rt/62/1/109 (accessed August 12, 2008).
32 Raub, W. Smallpox Vaccination Campaign: A
Federal Perspective. Washington, D.C.: U.S. 46 Sievert, D.M., J.T. Rudrik, J.B. Patel, L.C.
Department of Health and Human Services, McDonald, M.J. Wilkins, and J.C. Hageman.
March 3, 2003. <http://www.ahrq.gov/news/ “Vancomycin-Resistant Staphylococcus aureus in
ulp/smpoxtele/sess1/raubtxt.htm> (accessed the United States, 2002-2006.” Clinical Infectious
June 17, 2008). Diseases 46, no. 5. (March 1, 2008): 668-74.
http://www.journals.uchicago.edu/doi/full/10
33 National Institute of Allergy and Infectious .1086/527392 (accessed August 12, 2008).
Diseases. “Smallpox: Research.” U.S.
Department of Health and Human Services. 47 World Health Organization. “Communicable
http://www3.niaid.nih.gov/healthscience/heal Disease Prevention and Control: New, Emerg-
thtopics/smallpox/resarch.htm (accessed June ing, and Re-emerging Infectious Diseases.”
17, 2008). http://www.who.int/communicablediseaseprev
entionand controldiseases/en/ (accessed June
34 G8 Hokkaido Toyako Summit. Chair’s Summary. 11, 2008).
Hokkaido Toyako, Japan: Ministry of Foreign
Affairs of Japan, July 9, 2008. 48 Trust for America’s Health. Animal-Borne
http://www.g8summit.go.jp/eng/doc/doc0807 Epidemics Out of Control: Threatening the Nation’s
09_09_en.html (accessed July 9, 2008) Health. Washington, D.C.: Trust for America’s
Health, 2003: 2.
35 World Health Organization. “Control of
Neglected Tropical Diseases.” 49 U.S. Centers for Disease Control and
http://www.who.int/neglected_diseases/diseas Prevention. “Frequently Asked Questions about
es/en/alth (accessed June 11, 2008). SARS.” U.S. Department of Health and Human
Services. http://www.cdc.gov/ncidod/sars/
36 Smolinski, M.S., M.A. Hamburg, and J. faq.htm (accessed June 16, 2008).
Lederberg. Microbial Threats to Health:
Emergence, Detection, and Response. Washington, 50 Fauci, Anthony S. “NIH’s Research Response to
D.C.: The National Academies Press, 2003. Emerging and Re-emerging Infections Diseases:
http://www.nap.edu/catalog.php?record_id=1 Implications for Global Health.” Testimony
0636 (accessed June 18, 2008). before the House Subcommittee on Labor,
Health and Human Services, Education and
37 Taubes, G. “The Bacteria Fight Back.” Science Related Agencies, April 28, 2004.
321, no. 5887. (July 18, 2008): 356. http://www.hhs.gov/asl/testify/t040428a.html
38 National Institute of Allergy and Infectious (accessed June 16, 2008). 35
 51 Matsu, J. “Pandemic Fallout.” Presented at the 63 Osterholm, M.T. “Emerging Infectious Diseases:
Morgan Stanley, Global Economic Forum, A real public health crisis?” Postgraduate
February 28, 2006. Medicine Online 100, no 5. (November 1996).
http://www.morganstanley.com/views/gef/arc http://www.postgradmed.com/issues/1996/11
hive/2006/20060228-Tue.html#anchor0 _96/ed_nov.shtml (accessed July 21, 2008).
(accessed June 16, 2008). 64 Hotez, Peter J. Neglected Infections of Poverty in the
52 World Health Organization. “Epidemic and United States of America. Washington, D.C. Public
Pandemic Alert Response: Summary of Prob- Library of Science, 2008.
able SARS Cases with Onset of Illness from 1 http://www.plosntds.org/article/info%3Adoi%
November 2002 to 31 July 2003.” Based on data 2F10.1371%2Fjournal.pntd.0000256 (accessed
as of December 31, 2003. http://www.who.int/ September 5, 2008).
csr/sars/country/table2004_04_21/en/index.h 65 Ibid.
tml. (accessed June 17, 2008)
66 U.S. Homeland Security Council. National
53 Cooper, S. The Avian Flu Crisis: An Economic Strategy for Pandemic Influenza. Washington, D.C.:
Update. Toronto, Ontario: BMO Nesbitt Burns, The White House, May 2006.
March 13, 2006.
67 U.S. Centers for Disease Control and
54 Morens, D.M., G.K. Folkers and A.S. Fauci. Prevention. HIV/AIDS Surveillance Report, 2006.
“Challenge of Emerging and Re-emerging Volume 18. Atlanta: U.S. Department of Health
Infectious Diseases,” Nature 240, no. 6996 (July and Human Services, 2008.
8, 2004): 245. http://www.nature.com/nature/ http://www.cdc.gov/hiv/topics/surveillance/re
journal/v430/n6996/full/nature02759.html;jse sources/reports/ (accessed August 13, 2008).
ssionid=3A8F663E1F8A7226F80476B764533F7F
(accessed June 11, 2008). 68 U.S. Centers for Disease Control and
Prevention. “Estimates of New HIV Infections
55 Ellis, K.H. “Experts Warn of Potential Dengue in the United States.” U.S. Department of
Fever Outbreak in the United States.” Infectious Health and Human Services. August 2008.
Disease News, February 2008. http://www.cdc.gov/hiv/topics/surveillance/re
http://www.infectiousdiseasenews.com/200802 sources/factsheets/incidence.htm (accessed
/dengue.asp (accessed June 12, 2008). August 22, 2008).
56 Reed, K.D., J.K. Meece, J.S. Henkel, and S.K. 69 U.S. Centers for Disease Control and
Shukla. “Birds, Migration and Emerging Prevention. HIV/AIDS Surveillance Report, 2006.
Zoonoses: West Nile Virus, Lyme Disease, Volume 18. Atlanta: U.S. Department of Health
Influenza A and Enteropathogens.” Clinical and Human Services, 2008.
Medicine and Research 1, no. 1. (January 2003). http://www.cdc.gov/hiv/topics/surveillance/re
http://www.pubmedcentral.nih.gov/articleren sources/reports/ (accessed August 13, 2008).
der.fcgi?artid=1069015 (accessed July 21, 2008).
70 Kaiser Family Foundation. “HIV/AIDS.”
57 Ibid. http://www.kff.org/ (accessed August 13, 2008).
58 Patz, J.A., P. Daszak, G.M. Tabor et. al. 71 Kaiser Family Foundation. “Fact Sheet: U.S.
“Unhealthy Landscapes: Policy Federal Funding for HIV/AIDS: The FY 2009
Recommendations on Land Use Change and Budget Request.” April 2008.
Infectious Disease Emergence.” Environmental http://www.kff.org/hivaids/upload/7029-
Health Perspectives 112, no. 10 (July 2004): 1092. 041.pdf (accessed August 13, 2008).
http://www.ehponline.org/docs/ 2004/112-
10/toc.html (accessed July 21, 2008). 72 Kaiser Family Foundation. “Medicaid Spending
and Enrollment: State and National Data
59 Osterholm, M.T. “Emerging Infectious Diseases: Update.” http://www.kff.org/medicaid/
A Real Public Health Crisis?” Postgraduate (accessed August 13, 2008).
Medicine Online 100, no 5. (November 1996).
http://www.postgradmed.com/issues/1996/11 73 U.S. Centers for Disease Control and
_96/ed_nov.shtml (accessed July 21, 2008). Prevention. “CDC Estimates 94,000 Invasive
Drug-resistant Staph Infections Occurred in the
60 Global Health Council. “Infectious Diseases.” U.S. in 2005: Study Establishes Baseline for
http://www.globalhealth.org/view_top.php3?id MRSA Infection Estimates.” Press Release,
=228 (accessed July 22, 2008). October 16, 2007. http://www.cdc.gov/media/
61 Smolinski, M.S., M.A. Hamburg, and J. pressrel/2007/r071016.htm (accessed August
Lederberg. Microbial Threats to Health: 5, 2008).
Emergence, Detection, and Response. Washington, 74 Klein, E., D.L. Smith, and R. Laxminarayan.
D.C.: The National Academies Press, 2003: 63. “Hospitalizations and Deaths Caused by
http://www.nap.edu/catalog.php?record_id=10 Methicillin-Resistant Staphylococcus aureus,
636 (accessed June 18, 2008). United States, 1999-2005.” Emerging Infectious
62 Ibid, p. 125. Diseases 13, no.12. (December 2007).

36
75 U.S. Centers for Disease Control and 86 Tauxe, R.V. “Emerging Foodborne Diseases: An
Prevention. “Hepatitis C Information for the Evolving Public Health Challenge.” Emerging
Public.” U.S. Department of Health and Infectious Diseases 3, no. 4. (October - November
Human Services. http://www.cdc.gov/ 1997). http://www.cdc.gov/ncidod/eid/vol3
hepatitis/C/cFAQ.htm#cFAQ04 (accessed no4/tauxe.htm#table1 (accessed August 14, 2008).
August 14, 2008). 87 Ibid.
76 American Liver Foundation. “Hepatitis C.” 88 U.S. Centers for Disease Control and
http://www.liverfoundation.org/about/news/ Prevention. “Investigation of Outbreak of
(accessed August 14, 2008). Infections Caused by Salmonella Saintpaul.”
77 U.S. Centers for Disease Control and U.S. Department of Health and Human
Prevention. “Hepatitis C Investigation in a Las Services. http://cdc.gov/salmonella/
Vegas, Nevada Endoscopy.” U.S. Department of saintpaul/ (accessed August 15, 2008).
Health and Human Services. 89 U.S. Department of Agriculture. “Food
http://www.answers.com/topic/entomology Inspection Safety Service Recalls.”
(accessed August 14, 2008). http://www.fsis.usda.gov/FSIS_RECALLS/
78 Cain, K.P., S.R. Benoit, C.A. Winston, and W.R. (accessed August 15, 2008).
MacKenzie, “Tuberculosis Among Foreign- 90 Monke, J. Agroterrorism: Threats and Preparedness.
Born Persons in the United States.” Journal of Washington, D.C.: Congressional Research
the American Medical Association 300, no. 4. (July Service, 2004.
2008): 405-412. http://jama.ama-
assn.org/cgi/content/abstract/300/4/405 91 U.S. Homeland Security Council. Homeland
(accessed August 15, 2008). Security Presidential Directive/HSPD-9: Defense of
United States Agriculture and Food. Washington,
79 Ibid. D.C.: The White House, 2004.
80 National Institute of Allergy and Infectious 92 Webster’s New World Medical Dictionary, Fully
Diseases. “Dengue Fever: Overview.” U.S. Revised and Updated, 3rd Edition. Hoboken, New
Department of Health and Human Services. Jersey, Wiley Publishing, May 2008.
http://www3.niaid.nih.gov/healthscience/heal
thtopics/dengue/overview.htm (accessed June 93 Choffnes, E.R. “Improving Infectious Disease
12, 2008). Surveillance.” Bulletin of the Atomic Scientists.
Web edition, April 2008.
81 Ibid. http://www.thebulletin.org/web-edi-
82 Effler, P., L. Pang, P. Kitsutani, V. Vorndam, M. tion/features/improving-infectious-disease-sur-
Nakata, T. Ayers, et. al. “Dengue Fever, Hawaii, veillance. (accessed June 18, 2008).
2001-2002.” Emerging Infectious Diseases [serial on 94 U.S. Department of Health and Human
the Internet], May 2005. Services. “New International Health
http://www.cdc.gov/ncidod/EID/vol11no05/0 Regulations Enter into Force in the United
4-1063.htm. (accessed June 12, 2008). States.” News Release, July 18, 2007.
83 World Health Organization. “Food Safety and http://www.hhs.gov/news/press/2007pres/07/
Foodborne Illness.” WHO, March 2007, pr20070718a.html. (accessed July 15, 2008).
http://www.who.int/mediacentre/factsheets/fs 95 Young, D.B., M.D. Perkins, K. Duncan, and C.E.
237/en/ (accessed August 11, 2008). Barry. “Confronting the Scientific Obstacles to
84 World Health Organization. “Food Safety and Global Control of Tuberculosis.” The Journal of
Foodborne Illness.” WHO, March 2007, Clinical Investigation 118, no. 4 (April
http://www.who.int/mediacentre/factsheets/fs 2008):1255-1265.
237/en/ (accessed February 11, 2008). 96 Ellis, K. “One Health Initiative Will Unite
Medical costs and lost productivity due to food- Veterinary, Human Medicine: Experts Urge
borne illnesses were estimated to cost $35 bil- Collaboration Between Veterinarians, Physicians
lion annually in 1997. TFAH adjusted this fig- in Wake of Emerging Zoonotic Diseases, Potential
ure for inflation for 2007, the most recent year Epidemics.” Infectious Disease News. February 2008.
for which comparisons can be made. TFAH http://www.infectiousdiseasenews.com/200802/
used the Consumer Price Index calculation, veterinary.asp (accessed July 15, 2008).
which is the inflation measure cited by the U.S.
Department of Labor, Bureau of Labor 97 Ibid, p. 25.
Statistics. http://data.bls.gov/cgi-bin/cpicalc.pl 98 Infectious Diseases Society of America. “Bad
(accessed February 11, 2008). Bugs, No Drugs: As Antibiotic Discovery
85 Trust for America’s Health. Fixing Food Safety: Stagnates ...A Public Health Crisis Brews.” (July
Protecting America’s Food Supply from Farm-to-Fork. 2004): 18. http://www.idsociety.org/Work
Washington, D.C.: Trust for America’s Health, Area/showcontent.aspx?id=5554 (accessed
April 2008. http://healthyamericans.org/ August 5, 2008).
reports/foodsafety08/FoodSafety08.pdf 99 Idid. Content updated during a conversation
(accessed August 11, 2008). with IDSA staff member on August 4, 2008.
37
 100 U.S. Food and Drug Administration. White House, July 21, 2004. Remarks by the
Innovation/Stagnation: Challenge and Opportunity President at the Signing of S.15 - Project
on the Critical Path to New Medical Product. BioShield Act of 2004.
Washington, D.C.: U.S. Department of Health http://www.whitehouse.gov/news/releases/200
and Human Services, March 2004. 4/07/20040721-2.html (accessed June 18, 2008).
http://www.fda.gov/oc/initiatives/criticalpath 114 Assistant Secretary for Preparedness and
/whitepaper.html Response. “Biomedical Advanced Research
101 Smolinski, M.S., M.A. Hamburg, and J. and Development Authority.” U.S.
Lederberg. Microbial Threats to Health: Department of Health and Human Services.
Emergence, Detection, and Response. Washington, http://www.hhs.gov/aspr/barda/index.html
D.C.: The National Academies Press, 2003. (accessed July 3, 2008).
http://www.nap.edu/catalog.php?record_id= 115 Gottron, F. Project BioShield: Appropriations,
10636 (accessed June 18, 2008). Acquisitions, and Policy Implementation Issues for
102 Kaper, J., R. Rappuoli, and M. Buckley. Vaccine Congress. Washington, D.C.: Congressional
Development: Current Status and Future Trends. Research Service, March 8, 2007.
Washington, D.C.: American Academy of 116 Specifically, the legislation lists the following as
Microbiology, 2005: 6. diseases: tuberculosis, malaria, blinding tra-
103 U.S. Centers for Disease Control and Prevention. choma, buruli, ucler, cholera, dengue/
“Most U. S. Measles Cases Reported since 1996, dengue, haemorrhagic fever, Dracunculiasis
Many Unvaccinated because of Philosophical (guinea worm disease) Fascioliasis, Human
Beliefs.” U.S. Department of Health and Human African trypanosomiasis, Leishmaniasis,
Services. <http://www.cdc.gov/vaccines/vpd Leprosy, Lymphatic filariasis, Onchocerciasis,
vac/measles/default.htm> (accessed August 21, Schistosomiasis, Soil transmitted helmithiasis,
2008). Yaws; or any other disease for which there is
104 Miller, K. “Rift Valley Fever.” Science @ NASA, no significant market in developed nations
April 17, 2002. http://www.science.nasa.gov/ and disproportionately affects poor and mar-
headlines/y2002/17apr_rvf.htm (accessed ginalized populations.
May 18, 2008). 117 International AIDS Vaccine Initiative. “U.S.
105 Ibid. FDA Priority Review Vouchers: An Effective
Incentive to Develop Drugs and Vaccines for
106 Matheny, J., M. Mair, A. Mulcahy, and B.T. Neglected Diseases?” https://www.iavi.org/
Smith. “Incentives for Biodefense file.cfm?fid=47963 (accessed June 18, 2008).
Countermeasure Development.” Biosecurity
and Bioterrorism 5, no. 3. (2007). 118 Ibid.

107 Ibid. 119 Jack, A. “FDA to Stimulate Tropical Disease

Research.” Financial Times, May 1, 2008.
108 Novartis Pharmaceutical Corporation. http://www.ft.com/cms/s/0/6eb40e90-1716-
“Novartis Institute for Tropical Diseases.” 11dd-bbfc-0000779fd2ac.html (accessed May
http://www.nitd.novartis.com/corporate_rese 19, 2008).
arch/index.shtml (accessed May 19, 2008).
120 Library of Congress. “S. 2313: A Bill to Amend
109 The Global Alliance for TB Drug the Public Health Service Act to Enhance
Development. “Mission & History.” Efforts to Address Antimicrobial Resistance.”
http://www.tballiance.org/about/mission.php U.S. Congress. http://thomas.loc.gov/cgi-
. (accessed August 4, 2008) bin/bdquery/z?d110:s.02313: (accessed
110 GAVI Alliance (formerly the Global Alliance August 5, 2008).
for Vaccines and Immunization). “Fact Sheet.” 121 Smolinski, M.S., M.A. Hamburg, and J.
http://www.gavialliance.org/resources/3_EN_ Lederberg. Microbial Threats to Health:
GAVI_alliance.pdf (accessed April 13, 2008). Emergence, Detection, and Response. Washington,
111 Sabin Vaccine Institute. “Press Release: D.C.: The National Academies Press, 2003.
President Bill Clinton Inaugurates Sabin http://www.nap.edu/catalog.php?record_id=1
Vaccine Institute’s ‘Stop Neglected Tropical 0636 (accessed June 18, 2008).
Disease’ Campaign.” Released at the 2007 122 Ibid, p. 63.
Clinton Global Initiative, September 27, 2007.
http://www.stopntds.org (accessed January 123 National Institute on Allergy and Infectious
21, 2008). Diseases. “HIV/AIDS Overview.” U.S.
Department of Health and Human Services.
112 U.S. Food and Drug Administration. “Office http://www3.niaid.nih.gov/healthscience/hea
of Orphan Products Development Overview.” lthtopics/HIVAIDS/overview.htm (accessed
U.S. Department of Health and Human June 11, 2008).
Services. http://www.fda.gov/orphan/
progovw.htm (accessed June 18, 2008).
113 The White House. President Bush Signs Project
38 BioShield Act of 2004. Washington, D.C.: The
124 Mayo Clinic. “HIV/AIDS.” 135 National Institute of Allergy and Infectious
http://www.mayoclinic.com/health/hiv- Diseases. “Malaria: Symptoms.” U.S.
aids/DS00005/DSECTION=causes (accessed Department of Health and Human Services.
July 22, 2008). http://www3.niaid.nih.gov/topics/Malaria/u
125 UNAIDS. “2008 Report on the global AIDS nderstandingMalaria/transmission.htm
epidemic.” Joint United Nations Programme (accessed June 16, 2008).
on HIV/AIDS. http://data.unaids.org/pub/ 136 Ibid
GlobalReport/2008/jc1510_2008_global_rep 137 Mayo Clinic. “Tuberculosis: Introduction.”
ort_pp29_62_en.pdfIbid. (accessed July 30, http://www.mayoclinic.com/health/tuberculo
2008). sis/DS00372/DSECTION=1 (accessed June
126 The White House. President Bush Signs H.R. 17, 2008)
5501, the Tom Lantos and Henry J. Hyde United 138 National Institute of Allergy and Infectious
States Global Leadership Against HIV/AIDS, Diseases. “Tuberculosis (TB): Detailed
Tuberculosis and Malaria Reauthorization Act of Description of TB.” U.S. Department of
2008. Washington, D.C.: The White House, Health and Human Services.
July 30, 2008. http://www.whitehouse.gov/ http://www3.niaid.nih.gov/topics/tuberculosi
news/releases/2008/07/20080730-12.html s/Understanding/description.htm (accessed
(accessed July 31, 2008). June 17, 2008).
127 Ibid. 139 Ibid.
128 U.S. Centers for Disease Control and Preven- 140 National Institute of Allergy and Infectious
tion. HIV/AIDS Surveillance Report, 2006. Volume Diseases. “Tuberculosis (TB): Overview.” U.S.
18. Atlanta: U.S. Department of Health and Department of Health and Human Services.
Human Services, 2008. http://www.cdc.gov/ http://www3.niaid.nih.gov/topics/tuberculosi
hiv/topics/surveillance/resources/reports/ s/Understanding/overview.htm (accessed
(accessed August 13, 2008). June 17, 2008).
129 U.S. Centers for Disease Control and 141 National Institute of Allergy and Infectious
Prevention. “Estimates of New HIV Infections Diseases. “Tuberculosis (TB): Overview.” U.S.
in the United States.” U.S. Department of Department of Health and Human Services.
Health and Human Services. August 2008. http://www3.niaid.nih.gov/topics/tuberculosi
http://www.cdc.gov/hiv/topics/surveillance/ s/Understanding/overview.htm (accessed
resources/factsheets/incidence.htm June 17, 2008).
(accessed August 22, 2008).
142 U.S. Centers for Disease Control and Preven-
130 U.S. Centers for Disease Control and Preven- tion. “Tuberculosis: General Information.”
tion. HIV/AIDS Surveillance Report, 2006. U.S. Department of Health and Human
Volume 18. Atlanta: U.S. Department of Health Services. http://www.cdc.gov/tb/pubs/
and Human Services, 2008. tbfactsheets/tb.htm (accessed June 17, 2008).
http://www.cdc.gov/hiv/topics/surveillance/r
esources/reports/ (accessed August 13, 2008). 143 Ibid.

131 U.S. Centers for Disease Control and 144 National Institute of Allergy and Infectious
Prevention. “Hepatitis C Information for the Diseases. “Tuberculosis (TB): Detailed
Public.” U.S. Department of Health and Description of TB.” U.S. Department of
Human Services. http://www.cdc.gov/ Health and Human Services.
hepatitis/C/cFAQ.htm#cFAQ04 (accessed http://www3.niaid.nih.gov/topics/tuberculosi
August 14, 2008). s/Understanding/description.htm (accessed
June 17, 2008).
132 The C. Everett Koop Institute at Dartmouth
Medical School. Hepatitis C: An Epidemic 145 Ellis, K. “One Health Initiative Will Unite
for Anyone. Hanover, NH: The Trustees of Veterinary, Human Medicine: Experts Urge
Dartmouth College, 2008. Collaboration Between Veterinarians,
http://www.epidemic.org/theFacts/theEpide Physicians in Wake Of Emerging Zoonotic
mic/worldPrevalence/ (accessed July 7, 2008). Diseases, Potential Epidemics.” Infectious
Disease News. February 2008.
133 U.S. Centers for Disease Control and Preven- http://www.infectiousdiseasenews.com/20080
tion. “Hepatitis C Information for the Public.” 2/veterinary.asp (Accessed July 15, 2008).
U.S. Department of Health and Human
Services. http://www.cdc.gov/hepatitis/C/ 146 Ibid.
cFAQ.htm#cFAQ04 (accessed August 14, 2008). 147 U.S. Centers for Disease Control and
134 National Institute of Allergy and Infectious Prevention. “Influenza: Questions and
Diseases. “Malaria: Transmission.” U.S. Answers: The Disease.” U.S. Department of
Department of Health and Human Services. Health and Human Services.
http://www3.niaid.nih.gov/topics/Malaria/u http://www.cdc.gov/flu/about/qa/disease.ht
nderstandingMalaria/transmission.htm m 8 July 2007. (accessed June 16, 2008).
(accessed June 16, 2008).
39
 148 World Health Organization. “Cumulative 161 National Institute of Allergy and Infectious
Number of Confirmed Human Cases of Avian Diseases. “West Nile Virus: Research.” U.S.
Influenza A/(H5N1) Reported to WHO.” Department of Health and Human Services.
http://www.who.int/csr/disease/avian_influe http://www3.niaid.nih.gov/topics/westNile/u
nza/country/cases_table_2008_05_28/en/ind nderstanding/reserach.htm (accessed June
ex.html (accessed June 16, 2008). 17, 2008).
149 U.S. Centers for Disease Control and 162 Ellis, K. “One Health Initiative Will Unite
Prevention. “Questions and Answers About Veterinary, Human Medicine: Experts Urge
Avian Influenza (Bird Flu) and Avian Collaboration Between Veterinarians,
Influenza A (H5N1) Virus.” U.S. Department Physicians in Wake Of Emerging Zoonotic
of Health and Human Services. Diseases, Potential Epidemics.” Infectious
http://www.cdc.gov/flu/avian/gen- Disease News. February 2008.
info/qa.htm. (accessed June 16, 2008). http://www.infectiousdiseasenews.com/20080
150 Ibid. 2/veterinary.asp (accessed July 15, 2008).

151 National Institute of Allergy and Infectious 163 U.S. Centers for Disease Control and
Diseases. “Avian Influenza Trials.” U.S. Prevention. “Foodborne Illness.” U.S.
Department of Health and Human Services. Department of Health and Human Services.
http://www3.niaid.nih.gov/news/.htm. http://www.cdc.gov/ncidod/dbmd/diseaseinf
(accessed June 16, 2008). o/foodborneinfections_g.htm#typeschanging
(accessed July 22, 2008).
152 National Institute of Allergy and Infectious
Diseases. “Dengue Fever: Overview.” U.S. 164 Ibid.
Department of Health and Human Services. 165 National Institute of Allergy and Infectious
http://www3.niaid.nih.gov/healthscience/hea Diseases. “Botulism: Cause.” U.S. Department
lthtopics/dengue/overview.htm (accessed of Health and Human Services.
June 12, 2008). http://www3.niaid.nih.gov/healthscience/hea
153 Ibid. lthtopics/botulism/cause.htm (accessed June
17, 2008).
154 Effler, P., L. Pang, P. Kitsutani, V. Vorndam, M.
Nakata, T. Ayers, et. al. “Dengue Fever, Hawaii, 166 U.S. Centers for Disease Control and
2001-2002.” Emerging Infectious Diseases [ser- Prevention. “Facts about Botulism.” U.S.
ial on the Internet], May 2005. Department of Health and Human Services.
http://www.cdc.gov/ncidod/EID/vol11no05/ http://www.bt.cdc.gov/agent/botulism/factsh
04-1063.htm. (accessed June 12, 2008). eet.asp (accessed June 17, 2008).

155 National Institute of Allergy and Infectious 167 Ibid.

Diseases. “Lyme Disease.” U.S. Department of 168 Ibid.
Health and Human Services. 169 U.S. Centers for Disease Control and
http://www3.niaid.nih.gov/topics/lymeDiseas Prevention. “Escherichia coli O157:H7.” U.S.
e/understanding/intro.htm (accessed June Department of Health and Human Services.
16, 2008). http://www.cdc.gov/NCIDOD/DBMD/diseas
156 Ibid. einfo/escherichiacoli_g.htm#What%20is%20
157 Ibid. Escherichia%20coli%20O157:H7 (accessed
June 16, 2008).
158 U.S. Centers for Disease Control and
Prevention. “Questions and Answers about 170 Ibid.
Rift Valley Fever.” U.S. Department of Health 171 Ibid.
and Human Services. http://www.cdc.gov/ 172 Mayo Clinic. “Salmonella Infection.”
ncidod/dvrd/spb/mnpages/dispages/rv http://www.mayoclinic.com/health/salmonell
f/rvf_qa.htm (accessed July 22, 2008). a/DS00926 (accessed June 17, 2008).
159 National Institute of Allergy and Infectious 173 Ibid.
Diseases. “West Nile Virus: Symptoms.” U.S.
Department of Health and Human Services. 174 National Institute of Allergy and Infectious
http://www3.niaid.nih.gov/topics/westNile/ Diseases. “Salmonellas: Cause.” U.S.
understanding/symptoms.htm (accessed June Department of Health and Human Services.
17, 2008). http://www3.niaid.nih.gov/healthscience/hea
lthtopics/salmonellosis/Cause.htm (accessed
160 U.S. Centers of Disease Control and June 17, 2008).
Prevention. “2007 West Nile Virus Activity in
the United States.” U.S. Department of Health 175 National Institute of Allergy and Infectious
and Human Services. http://www.cdc.gov/ Diseases. “Salmonellas: Overview.” U.S.
ncidod/dvbid/westnile/surv&controlCaseCou Department of health and Human Services.
nt07_detailed.htm (accessed August 13, 2008). http://www3.niaid.nih.gov/healthscience/hea
lthtopics/ salmonellosis/Overview.htm
(accessed June 17, 2008).
40
1730 M Street, NW, Suite 900
Washington, DC 20036
(t) 202-223-9870
(f) 202-223-9871