Progress in Combating Neglected Tropical Diseases (NTDs): U.S. and Global Efforts from FY2006 to FY2015

Congressional research reportMay 28, 2014

Ask Donna

What actually matters in this document.

Text

Progress in Combating Neglected Tropical

Diseases (NTDs): U.S. and Global Efforts

from FY2006 to FY2015

(name redacted)

Specialist in Global Health

May 28, 2014

Congressional Research Service

7-....

www.crs.gov

R42931

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Summary

The term “neglected tropical diseases” (NTDs) was coined by the World Health Organization

(WHO) in 2003 to describe a set of diseases that are ancient, worsen poverty, and typically impair

health and productivity while carrying low death rates. While the use of the term “NTDs” has

helped to raise awareness about these long-standing health challenges, its use risks simplifying a

complicated health challenge. Some of the diseases are treatable with drugs that can be

administered by lay health workers irrespective of disease status, while others require diagnosis

and can be treated only by trained health professionals who have access to appropriate equipment,

electrical power, and refrigeration (to store the temperature-sensitive therapies).

Neglected tropical diseases primarily plague the poorest people in developing countries. Changes

in the environment and population flows, however, make industrialized countries, including the

United States, increasingly vulnerable to some NTDs, particularly dengue haemorrhagic fever,

which can cause death and has no cure. Health interventions to address the array of NTDs vary,

but a common factor to an enduring solution to these illnesses is economic development.

Industrialized countries, including the United States, have controlled these diseases in their

territories by combining drug treatment with the construction and use of improved sanitation,

modernization of agricultural practices, and utilization of improved water systems.

The international community has made substantial progress in combating select NTDs, though

some have been tackled more effectively than others. Guinea worm disease, for example, is on

the cusp of eradication. More generally, expanding access to mass drug administration is

contributing to decreases in prevalence of several NTDs, particularly across Latin America.

Despite these advances, WHO cautions that these diseases cannot be banished without improving

global access to clean water and sanitation, strengthening local health capacity (veterinary as well

as human), and intensifying case detection and management. Making improvements in these areas

will require long-term investments that are complex and may entail facing thorny issues such as

addressing corruption, transferring ownership of health programs from donors to recipient

countries, and evaluating the impact of political and economic policies on health programs (e.g.,

international lending requirements).

The United States has played an important role in combating NTDs. Congressional interest in

NTDs has been growing. Appropriations for NTD programs have steadily increased from $15

million in FY2006 to $100 million in FY2014. In May 2014, President Barack Obama announced

that the U.S. Agency for International Development (USAID) had supported the delivery of the

one billionth NTD treatment and had reached nearly half a billion people. The Administration

requested $86.5 million to support NTD programs in FY2015. Between FY2006 and FY2012,

U.S. funding has supported the delivery of nearly 585 NTD treatments, reaching 258 million

people. This report discusses the prevalence of NTDs, U.S. and global actions to address them,

and options the 113th Congress might consider. For additional background on NTDs, including

photographs and discussions about transmission of NTDs, descriptions of activities to combat

NTDs by other agencies, and additional policy issues, see CRS Report R41607, Neglected

Tropical Diseases: Background, Responses, and Issues for Congress.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Contents

Introduction...................................................................................................................................... 1

NTD Control.............................................................................................................................. 2

Global Progress in Combating NTDs .............................................................................................. 3

International Pledges to Combat NTDs ..................................................................................... 4

Funding and Resource Gaps ...................................................................................................... 5

Research and Development Needs ............................................................................................ 6

U.S. Efforts to Tackle NTDs ............................................................................................................ 8

The USAID NTD Program ........................................................................................................ 8

Issues for Congress ........................................................................................................................ 10

Accessing Clean Water and Sanitation .................................................................................... 10

Integrating the U.S. NTD Program.......................................................................................... 11

Strengthening Health Systems ................................................................................................. 12

Addressing Research and Development Needs ....................................................................... 13

Figures

Figure 1. Global NTD Burden Map ................................................................................................. 1

Figure 2. Share of NTD Burden by Disease .................................................................................... 2

Figure 3. Timeline of Key Global Actions to Address NTDs .......................................................... 3

Figure 4. Global Guinea Worm Disease and HAT

Cases: 1995-2012 ......................................... 4

Figure 5. Donated NTD Treatments, 2009-2013 ............................................................................. 5

Figure 6. Numbers of People Needing and Receiving Treatment for Key NTDs............................ 6

Figure 7. Global Progress on 2020 Goals ........................................................................................ 7

Figure 8. USAID NTD Program: FY2007-FY2013 ........................................................................ 9

Figure B-1. NTD Program Countries ............................................................................................ 19

Figure B-2. Deworming Treatment Access Trends: 2003-2012 .................................................... 20

Tables

Table 1. 17 Neglected Tropical Diseases ......................................................................................... 2

Table A-1. London Declaration: Table of Donor Commitments.................................................... 15

Appendixes

Appendix A. London Declaration: Table of Donor Commitments ................................................ 15

Appendix B. Map of USAID NTD Program ................................................................................. 19

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Contacts

Author Contact Information........................................................................................................... 21

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Introduction

Over the past decade, global health has become a priority in U.S. foreign policy, and U.S.

appropriations for global health-related efforts have more than tripled. Neglected tropical diseases

(NTDs) have become an important part of these efforts.1 Congressional appropriations for NTDs

have grown from $15 million in FY2006 to $100 million in FY2014. The Administration

requested $86.5 million to support NTD programs in FY2015. Heightened congressional interest

in combating NTDs has been reflected not only in higher appropriation levels but also in the

development of caucuses on these issues. In October 2009, the House Malaria Caucus expanded

its purview to include NTDs, and in September 2012, the Senate Malaria Caucus did the same.

Tropical diseases encompass all diseases that occur solely, or principally, in the tropics. Of these,

the World Health Organization (WHO) describes 17 as “neglected,” since resources for curing,

controlling, and researching improved treatments for these were limited until recently. The 17

NTDs are found mostly among the poorest people in 149 countries and territories (Figure 1),

primarily where access to clean water, sanitation, and health services is limited. Some NTDs are

transmitted by people; others are spread by vectors like snails, flies, or mosquitoes; and several

others proliferate in soil or water. Among the 17 NTDs, 7 account for roughly 90% of the global

NTD burden (Table 1). These are the three soil-transmitted helminths (intestinal worms),

schistosomiasis (snail fever), lymphatic filariasis (elephantiasis), trachoma, and onchocerciasis

(river blindness). Intestinal worms, or STH, account for roughly 80% of the seven most common

NTDs (Figure 2).

Figure 1. Global NTD Burden Map

Source: Adapted by CRS from Uniting to Combat NTDs, http://unitingtocombatntds.org/sites/default/files/

resource_file/ntd_event_burden_map_updated.pdf, May 6, 2014.

For additional background information on NTDs, see CRS Report R41607, Neglected Tropical Diseases:

Background, Responses, and Issues for Congress, by (name redacted).

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Table 1. 17 Neglected Tropical Diseases

Seven Most Common NTDs (90% of all NTDs)

Other NTDs

Lymphatic Filariasis (Elephantiasis)

Buruli Ulcer

Onchocerciasis (River Blindness)

Chagas Disease

Schistosomiasis (Snail Fever)

Cysticercosis/Taeniasis

Soil-Transmitted Helminthiases (STH)

Dengue

• Hookworm

Dracunculiasis (Guinea worm disease)

• Whipworm

Echinococcosis

• Roundworm

Foodborne Trematode Infections

Trachoma

Human African Trypanosomiasis (Sleeping Sickness)

Leishmaniasis

Leprosy

Rabies

Yaws

Source: Created by CRS from WHO website on NTDs, http://www.who.int/neglected_diseases/diseases/en/,

November 7, 2012.

NTD Control

Figure 2. Share of NTD Burden by Disease

NTD control efforts are

grouped into two categories:

those that require individual

treatment and those that can be

addressed by mass drug

administration (MDA).

Several NTDs can be

addressed through MDA,

when an entire community

with known cases is treated

irrespective of individual

disease status.2 Of the 17

NTDs, 8 can be treated with

MDA. These include the seven

most common NTDs as well

as foodborne trematode

infections.3

Source: Adapted by CRS from WHO fact sheets on NTDs. WHO, “Sustaining

The Drive To Overcome The Global Impact Of Neglected Tropical Diseases,”

Second WHO Report on Neglected Tropical Diseases, 2013.

Although the seven most

common NTDs can be treated with MDA, complex transmission cycles complicate efforts to

eliminate or eradicate4 them. STH, for example, is contracted through contact with or ingestion of

WHO, “Sustaining The Drive To Overcome The Global Impact Of Neglected Tropical Diseases,” Second WHO

Report on Neglected Tropical Diseases, 2013, pp. 114.

Ibid., pp. 18-106.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

worm eggs that lie in soil. The eggs are deposited in the soil through fecal matter and can remain

there for several years. Access to adequate sanitation facilities is a critical component of

interrupting the STH transmission cycle, as the STH medicines kill the adult worms, but not the

eggs. Due to the limitations of drugs, WHO recommends a five-pronged strategy:5

• mass drug administration

• innovative and intensified diseasemanagement;

Figure 3. Timeline of Key Global Actions to

Address NTDs

• vector control and pesticide

management;

• safe-drinking water, basic sanitation and

hygiene services, and education; and

• veterinary public-health services.

Global Progress in

Combating NTDs

Since WHO coined the phrase “neglected

tropical diseases” in 2003, global efforts to

address these ailments have accelerated. In

2007, WHO released the Global Plan to

Combat Neglected Tropical Diseases, which

outlined several goals and targets to reach by

2015 for global control, elimination, and

eradication of NTDs (Figure 3).6 In 2012,

WHO released a report, widely known as the

Roadmap, which highlighted progress in

reaching the 2015 goals and established new

ones for 2020.7 One year later, it released a

report outlining progress in achieving the

2020 goals, as described in the Roadmap.

According to the reports, guinea worm

disease has been nearly eliminated and was

endemic in only four countries by 2012:

Chad, Ethiopia, Mali, and South Sudan.

Source: Created by CRS.

(...continued)

Eradicate means to end all transmission of a disease worldwide by exterminating the agent. Eliminate means to

reduce transmission of a disease (not necessarily zero) with the aim of interrupting the transmission cycle.

WHO, “Sustaining The Drive To Overcome The Global Impact Of Neglected Tropical Diseases,” Second WHO

Report on Neglected Tropical Diseases, 2013, p. 113-129.

WHO, Global Plan to Combat Neglected Tropical Diseases 2008-2015, 2007.

Ibid., Accelerating Work to Overcome the Global Impact of Neglected Tropical Diseases: A Roadmap for

Implementation, 2012.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Nearly 97% of the 542 cases identified in 2012 occurred in South Sudan, where instability

remains a key threat to eradication. Since the 2012 report was released, WHO has noted further

progress in addressing guinea worm disease, with 148 cases reported in 2013 and only 10 cases

reported from January 1, through April 30, 2014.8 WHO has also since noted progress in other

areas. Annual sleeping sickness cases, for example, fell by more than 70% from 1995 through

2012 (Figure 4).9

Figure 4. Global Guinea Worm Disease and HAT Cases: 1995-2012

(millions)

Source: Created by CRS from WHO, Accelerating Work to Overcome the Global Impact of Neglected Tropical

Diseases: A Roadmap for Implementation, 2012, p. 76 and WHO, Control and Surveillance of Human African

Trypanosomiasis, WHO Technical Report Series, Number 984, 2013, pp. 16 and 18.

International Pledges to Combat NTDs

In January 2012, representatives from endemic countries, the private sector, and donor nations

convened in London, England, to affirm their commitment to combatting NTDs. Participants

signed the London Declaration on Neglected Tropical Diseases, which highlighted the role each

signatory would play in reaching the 2020 goals outlined in the Roadmap. Appendix A lists

donor commitments.10 These pledges included the following:

WHO, Reaching WHO Roadmap Targets Is Top Priority In A Changing NTD Landscape, press release, May 1, 2014.

WHO, Control and Surveillance of Human African Trypanosomiasis, WHO Technical Report Series, Number 984,

2013, pp. 16 and 18.

http://www.unitingtocombatntds.org/downloads/press/ntd_event_table_of_commitments.pdf.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

•

$785 million (includes preexisting commitments) to strengthen drug distribution

and program implementation;

•

1.4 billion drug treatments annually;

•

access to drug compound libraries to identify new treatments;

•

increased financial support for NTD programs (some of which amended previous

commitments to ongoing efforts), such as:

•

commitments by the governments of Bangladesh, Brazil, Mozambique, and

Tanzania to devote political and financial resources to combat endemic NTDs.

Funding and Resource Gaps

Annual donations of NTD

treatments have continued to

grow (Figure 5). In 2013,

donors provided nearly 1.35

billion NTD treatments, up

from 995 million in 2011.

Nonetheless, these treatments

are expected to reach only

36% of those who need them,

with some 1.4 billion people

lacking access.11 Treatment

access rates vary per disease

and region. For example,

roughly 37% of children with

STH in need of deworming

received treatment in 2012

(Figure 6).12 Regional

treatment rates ranged from

7% in the Middle East to 47%

in Southeast Asia.13

Pharmaceutical companies

have donated sufficient

supplies of medicines for most

NTDs, yet a $1.4 billion

funding gap persists.14 Health

analysts assert that an

additional $200 million is

needed annually between 2014

Figure 5. Donated NTD Treatments, 2009-2013

(thousands)

Source: Adapted by CRS from Uniting to Combat NTDs, Delivering on

Promises and Driving Progress, 2014, p. 14.

Uniting to Combat NTDs, Delivering on Promises and Driving Progress, 2014, p. 9.

WHO, “Preventive Chemotherapy, Planning, Requesting Medicines, and Reporting,” Weekly Epidemiological

Record, (February 21, 2014), Number 8, Volume 89, pages 61-72.

WHO, “Soil-transmitted helminthiases: number of children treated in 2012,” Weekly Epidemiological Record, 2014,

volume 89, number 13, pp. 133-140.

Uniting to Combat NTDs, Delivering on Promises and Driving Progress, 2014, p. 18.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

and 2020 to deliver the donated drugs and meet other programming costs. The $1.4 billion does

not include additional resources needed for research and development (R&D) of new treatments,

vaccines, and testing supplies.

Figure 6. Numbers of People Needing and Receiving Treatment for Key NTDs

(thousands and percent)

Source: WHO, “Preventive Chemotherapy, Planning, Requesting Medicines, and Reporting,” Weekly

Epidemiological Record, (February 21, 2014), Number 8, Volume 89, pages 61-72.

Research and Development Needs15

NTD experts maintain R&D is vital. Some observers are troubled by emerging evidence that

hookworm, one of the STHs (that comprise 80% of all NTDs), may be developing resistance to

existing medication.16 In addition, the international community cannot meet 2020 goals with

existing tools (Figure 7). There is an urgent need for additional drug treatments and vaccines for

those NTDs that are difficult to treat, are costly to manage, and can have severe clinical outcomes

if left untreated.17 These are Buruli ulcer, Chagas disease, human African trypanosomiasis, the

leishmaniases, leprosy and yaws. Given the complexity of these diseases, patients must be seen at

well-equipped health facilities by well-trained, specialized technicians; these types of facilities

may not be available in many of the affected countries. Additionally, exposed populations need to

Judith Glassgold, former Specialist in Health Policy, contributed to this section.

Hotez, Peter “Mass Drug Administration and Integrated Control for the World’s High-Prevalence Neglected Tropical

Diseases,” Clinical Pharmacology & Therapeutics, vol. 85, no. 6 (June 2009), pp. 659-664.

WHO, “Sustaining The Drive To Overcome The Global Impact Of Neglected Tropical Diseases,” Second Report on

Neglected Tropical Diseases, 2013, p. 119.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

be systematically screened because these diseases are generally asymptomatic during the periods

when treatments would be most effective and carry the least dangerous side-effects.18

In addition to the above-mentioned diseases, dengue has become a growing global health

problem.19 Dengue is the leading cause of serious illness and death among children in some Asian

and Latin American countries. More than 2.5 billion people are now at risk of infection, close to

40% of the world’s population. Of these, between 50 million and 100 million contract the disease

annually. Before 1970, only nine countries had experienced severe dengue epidemics. The disease

is now endemic in more than 100 countries. Dengue has been detected in a number of U.S. states

and territories, including Florida, Texas, and Puerto Rico.20 There is no specific treatment or

vaccine for dengue, which can lead to death if left untreated. Early detection and proper care can

reduce fatality rates from about 20% to less than 1%.

Figure 7. Global Progress on 2020 Goals

Source: Adapted by CRS from Uniting to Combat NTDs, October 25, 2012.

Notes: “Possible progress with existing tools” predicts advancement of elimination and control efforts without

development of new tools. “Possible progress with new tools” predicts advancements that could be made if new

tools were developed, such as more effective treatments and vaccines.

* Guinea worm disease is targeted for eradication.

Acronyms: Lymphatic Filariasis (LF), Human African Trypanosomiasis (HAT), Soil-Transmitted Helminths (STH).

Congress has taken steps to encourage drug development for certain diseases; some NTDs are

among them. Two pieces of legislation established a framework for incentivizing drugs for rare

diseases or disorders: The Orphan Drug Act of 1983, P.L. 97-414, followed by the Rare Diseases

Ibid., p. 116.

Information in this paragraph was summarized from WHO, Dengue and Severe Dengue, fact sheet, number 117,

November 2012.

G. Vaidyanathan, “Dengue Re-emerges in the U.S., Spurring Race for Vaccine,” New York Times, June 28, 2012; M.

McKenna, “Dengue, aka ‘Breakbone Fever,’ is back,” Slate, December 12, 2012. See also, Centers for Disease Control

and Prevention http://diseasemaps.usgs.gov/del_us_human.html.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Act of 2002, P.L. 107-280. These acts defined rare diseases or disorders as those that affect fewer

than 200,000 individuals in the United States. This definition includes NTDs and other rare or

orphan conditions.21 Through these programs, 26 drugs received a new drug approval (NDA) or a

biologic license application in 2012.22

The FDA Amendments Act of 2007 (P.L. 110-85) created a priority review voucher (PRV) to

incentivize the development of drugs and biologic products for tropical diseases. The applicant

would receive a voucher at the time of approval of certain tropical disease products that “offer

major advances in treatment where no adequate therapy exists.”23 This voucher would allow the

applicant a priority review of another drug product. This voucher could be transferred (sold) to

one other sponsor. The draft guidance issued by the FDA describes the diseases and conditions

covered by the PRV.

The act also permits the Secretary to designate other diseases by regulation, which could include

“any infectious disease for which there is no significant market in developed nations and that

disproportionately affects poor and marginalized populations.... ”24 The list includes tropical

diseases beyond the 17 NTDs, namely cholera, malaria, and tuberculosis (TB). At the same time,

the act excludes some NTDs listed by WHO, including rabies, cysticercosis/taeniasis, and Chagas

disease.

U.S. Efforts to Tackle NTDs

A variety of U.S.-based institutions support global efforts to control NTDs. These institutions

include the federal government, pharmaceutical companies, philanthropic organizations, and

NGOs. Key U.S. government players include the U.S. Agency for International Development

(USAID), U.S. Centers for Disease Control and Prevention (CDC), National Institutes of Health

(NIH), and Department of Defense (DOD).25 NGOs include groups like the Carter Center and

RTI International; philanthropic organizations include the Gates Foundation and the Sabin

Vaccine Institute; and private companies include Merck, Johnson & Johnson and Pfizer. While

each of these plays an important role in combating NTDs, this section focuses exclusively on the

USAID-managed NTD Program.26

The USAID NTD Program

In 2006, the Bush Administration launched the Neglected Tropical Disease Control Program, the

first U.S. effort to address a group of NTDs. The program was created in response to language in

the FY2006 Foreign Operations Appropriations Act, which made available up to $15 million “to

Information from the FDA on orphan and rare conditions is available at http://www.fda.gov/ForIndustry/

DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm216147.htm, including

a database or rare conditions.

Email from FDA Office of Legislation on March 8, 2013.

See FDA “Guidance for Industry: Tropical Disease Priority Review Vouchers, October 2008, p.3.

Ibid.

For more information on related efforts by these agencies, see CRS Report R41607, Neglected Tropical Diseases:

Background, Responses, and Issues for Congress, by (name redacted).

See respective websites of each organization for additional information on their NTD Programs.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

support an integrated response to the control of neglected diseases including intestinal parasites

[STH], schistosomiasis, lymphatic filariasis, onchocerciasis, trachoma and leprosy.”27 The

language signaled congressional support for calls to integrate and expand access to drugs for the

seven most common NTDs. Until that time, most countries and their implementing partners

focused on tackling a single NTD. The NTD Program sought to document the feasibility of

integrating treatment for several NTDs and expanding this strategy. At the outset, the NTD

program aimed to support the provision of 160 million NTD treatments to 40 million people in 15

countries. In 2008, President George W. Bush reaffirmed his commitment to the program and

proposed spending $350 million over six years (from FY2008 through FY2013) on expanding the

program to 30 countries.28

Source: Created by

CRS from NTD

Program website at

http://www.neglecte

ddiseases.gov/

approaches/

index.html, May 9,

2014.

Figure 8. USAID NTD Program: FY2007-FY2013

During his first term,

President Barack

Obama named the

NTD Program a

priority. The Obama

Administration

announced several

goals for addressing

NTDs, including

• administer 1

billion NTD

treatments,

• halve the prevalence of the seven most common NTDs by 2013,

• eliminate leprosy in all endemic countries and onchocerciasis in Latin America by

2016, and

• eliminate lymphatic filariasis globally by 2017.

On May 8, 2014, the Obama Administration announced that it had administered its one billionth

NTD treatment, reaching 465 million people and surpassing one of its goals.29 From FY2007

through FY2013, USAID spent more than $370 million on global NTD programs (Figure 8). In

FY2014, Congress appropriated $100 million for NTD programs and the Administration requests

$86.5 million for NTD programs in FY2015. A map of the countries receiving USAID support for

combating NTDs is in Appendix B.

Section 593, P.L. 109-102, FY2006 Foreign Operations Appropriations.

See White House, “President Bush Announces New Global Initiative To Combat Neglected Tropical Diseases,”

press release, February 20, 2008.

USAID NTD website, http://www.neglecteddiseases.gov/, May 9, 2014.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Issues for Congress

The international community has made substantial progress in combating select neglected tropical

diseases. Some NTDs have been tackled more effectively than others. Guinea worm disease, for

example, is on the cusp of eradication and with expanding mass drug administration campaigns,

the prevalence of several NTDs is declining, particularly in Latin America. Despite these

advancements, WHO cautions in the 2020 Roadmap that these diseases cannot be banished

without expanding global access to clean water and sanitation, improving hygiene practices,

strengthening local health capacity (veterinary as well as human), and intensifying case detection

and management.

The United States has played an important role in combating NTDs and will likely be a central

player in global efforts to advance the 2020 NTD goals. The section below discusses a range of

issues U.S. and international organizations may face as they attempt to reach the WHO 2020

goals, as well as those set by the Administration (see “U.S. Efforts to Tackle NTDs”). Some of the

discussion includes an analysis of steps the 113th Congress might consider.

Accessing Clean Water and Sanitation

Transmission of most NTDs is facilitated by insufficient access to clean water, sanitation, and

hygiene (WASH).30 An estimated 880 million children are carrying soil-transmitted helminths, for

example, which are spread primarily through openly defecating on the ground. Eggs of these

intestinal worms, which account for roughly 80% of NTDs, can persist in the environment for

many years.

Experts at the CDC assert that WASH should be a central component of any effective and

sustainable approach to controlling NTDs.31 One estimate indicates that improved sanitation and

water safety can reduce the prevalence rates of other NTDs as well, including schistosomiasis and

blinding trachoma.32 Water and sanitation improvement are particularly important when

addressing pathogens that cannot be eliminated by drugs alone, such as STH and schistosomiasis.

Several experts urge greater investments in water and sanitation and see attainment of global

water and sanitation goals as an important step towards eliminating NTDs.33 Through the

Millennium Development Goals (MDGs), the international community sought to halve the share

of people without access to clean water and basic sanitation by 2015.34 WHO estimated that

For more information on U.S. and international efforts to improve access to clean water and sanitation, see CRS

Report R42717, Global Access to Clean Drinking Water and Sanitation: U.S. and International Programs, by (name

redacted).

See CDC, WASH Away Neglected Tropical Diseases, Activity Summary, June 2010, http://www.cdc.gov/

healthywater/pdf/global/programs/wash-away-ntd-summary.pdf and CDC, WASH Away Neglected Tropical Diseases,

Program in Brief, June 2010.

Philip Musgrove and Peter Hotez, “Turning Neglected Tropical Diseases Into Forgotten Maladies,” Health Affairs,

vol. 28, no. 6 (November/December 2009), p. 1698.

Burton Singer, “Viewpoint by Burton Singer: Bring Back Primary Prevention for Relieving the Burden of NTDs,”

PLoS Medicine, vol. 7, no. 5 (May 2010), p. e1000255; and TR Burkot et al., “The Argument for Integrating Vector

Control with Multiple Drug Administration Campaigns to Ensure Elimination of Lymphatic Filariasis,” Filaria

Journal, vol. 5, no. 10 (August 2006).

The United Nations (U.N.) General Assembly adopted a declaration in 2000, which among other things, committed

(continued...)

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

between 2005 and 2015, it would cost $72 billion annually to implement and maintain enough

water and sanitation schemes to meet global water and sanitation targets, of which $54 billion

would need to be spent on maintaining the systems.35 In 2010, members of the Organization for

Economic Cooperation and Development (OECD) committed $7.8 billion towards improving

global access to clean drinking water and sanitation.36 U.S. and global investments in sanitation

would need to increase significantly to meet this funding gap.

Integrating the U.S. NTD Program

Investments in WASH are considered important, as mass drug administration campaigns cannot

be used in isolation to eliminate NTDs. The process of combating diseases by combining

responses by practitioners across sectors, particularly those related to health, agriculture, water,

construction, and waste disposal, is known as integrated vector management. Indeed, the United

States was unable to control hookworm (an STH) within its own borders until the early 1900s,

when an integrated vector management (IVM) approach was applied.37

Documents by the Administration maintain the NTD Program is part of a complete package of

services the United States provides to improve the health of women and children across sectors.38

The Administration intends, for example, to expand the provision of drugs that treat STH in

children within USAID-supported education programs.39 Similarly, the Obama Administration

underscores the intersection between water and sanitation and categorizes it as a “cross-cutting

area” under global health. Nonetheless, in reports to Congress on progress towards advancing

global health (through congressional budget justifications, for example) the Administration

provides little information about how water and sanitation programs advance global health efforts

or how they are integrated within global health projects.

The structure of the FY2013 Foreign Operations budgetary request suggests some separation

between these activities. Requests for water programs are made across a variety of accounts,

(...continued)

member states to advance health development around the world. See, United Nations Millennium Declaration,

September 18, 2000, http://www.un.org/millennium/declaration/ares552e.pdf. Shortly thereafter, delegates developed

the Millennium Development Goals (MDGs) to guide attainment of the priorities outlined in the Millennium

Declaration. The eight MDGs are: (MDG1) eradicate poverty and hunger, (MDG2) achieve universal primary

education, (MDG3) promote gender equality and empower women, (MDG4) reduce child mortality by two-thirds,

(MDG5) reduce maternal mortality by two-thirds, (MDG6) combat HIV/AIDS, malaria, and other diseases, (MDG7)

ensure environmental sustainability, and (MDG8) develop a global partnership for development. MDG7 includes the

water and sanitation targets.

Guy Hutton and Jamie Bartram, Regional and Global Costs of Attaining the Water Supply and Sanitation Target of

the Millennium Development Goals, WHO, 2008, p. iv, http://www.who.int/water_sanitation_health/

economic_mdg_global_costing.pdf.

OECD, Aid Activity Database, http://stats.oecd.org/Index.aspx, July 31, 2012. For more information on U.S.

spending on improving global access to water and sanitation, see CRS Report R42717, Global Access to Clean

Drinking Water and Sanitation: U.S. and International Programs, by (name redacted).

In the early 1900s, the Rockefeller Foundation and its implementing partners combined wide-scale sanitation projects

with drug administration and public education to eliminate hookworm infections, which plagued much of the

southeastern United States at the time. For more on this approach, see E.A. Alderman et al., The Rockefeller Sanitary

Commission for the Eradication of Hookworm Disease (Washington, DC: Offices of the Commission, 1915). This book

is available on-line at http://www.archive.org/details/cu31924005710839.

Department of State, Implementation of the Global Health Initiative: Consultation Document, February 2010, p. 20.

Ibid., p. 15.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

primarily Development Assistance (DA) and Economic Support Fund (ESF). In FY2013, for

example, the Administration requested only 12% of water and sanitation funds through the Global

Health Programs account and 76% through the DA and ESF accounts. These two accounts

support a wide range of governance and economic development activities, which do not typically

focus on health objectives.

Despite the limitations of mass drug administration, the U.S. NTD Program focuses almost

exclusively on MDA. Administration officials recognize the importance of a comprehensive NTD

Program, but maintain that “the directive from Congress was to focus on mass drug

administration. [G]iven the limited resources, [MDA] is the most efficient and cost-effective way

to control [and] eliminate these diseases.”40 The 113th Congress might debate the merits of

applying an intersectoral approach to the NTD Program. Broadening the U.S. approach may not

necessarily entail raising spending, but could involve improving the integration of U.S. health and

development programs. The 113th Congress could, for example, request information on how key

leaders at USAID (e.g., the Deputy of the Global Health Initiative and the Water Coordinator)

coordinate their programs.

Strengthening Health Systems

Although pharmaceutical companies have donated sufficient supplies of NTD medicines, more

than 60% of those in need of NTD treatment lack access to the drugs. Broader issues associated

with weak health systems within endemic countries can affect the delivery of drugs and the

effectiveness of NTD programs.41 Since many endemic countries are largely responsible for

disseminating the donated medicines, human resource constraints and supply chain deficiencies

inhibit supply of the drugs and leave many without access to treatment. Streamlining and

simplifying treatments are becoming increasingly important.42 The international community is

increasingly integrating treatments and services, particularly for multiple diseases that can be

treated with one pill. Lymphatic filariasis and the three most common intestinal worms, for

example, can be treated with the same medication. Health providers are partnering with schools to

couple LF and STH treatment with school feeding programs. Some are concerned, however, that

deworming treatment rates are declining among children who are not yet old enough to attend

school (Figure B-2).

Weak veterinary and public health systems limit the ability of several affected countries to

enhance NTD programs or maintain them after international support wanes. Many critics of

“vertical” or “disease-specific” programs see the poor conditions of health systems in several

developing countries as an outcome of the burgeoning investments in vertical disease programs.

One argument is that disease-specific efforts divert investments from the very public health

systems that are needed to support vertical programs. Supporters of disease-specific initiatives

argue, on the other hand, that such activities facilitate dramatic, measurable progress. Advocates

of this approach point to dramatic reductions in recent years of deaths associated with HIV/AIDS

and malaria. The merits of vertical disease programs have been long debated in the global health

community and evidence supports both sides of the debate.

Emily Wainwright, USAID, Senior Operations Advisor, Neglected Tropical Diseases Program, December 27, 2012.

See WHO Report on Infectious Diseases, “Removing Obstacles to Healthy Development,” http://www.who.int/

infectious-disease-report/pages/textonly.html. For more information on these issues see CRS Report R41607, Neglected

Tropical Diseases: Background, Responses, and Issues for Congress, by (name redacted).

Ibid.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Addressing Research and Development Needs43

Despite support by health analysts and scientists for increasing drug and vaccines for NTDs,44

funding for pharmaceutical R&D is considered by many to be insufficient.45 To date, efforts to

encourage private development of NTD vaccines and drugs have met tepid responses, due in part

to the belief that there is no viable commercial market for these products.46 It is widely

understood that NTDs affect primarily the poorest in developing countries, most of whom lack

resources to afford drugs. Without guarantees of cost recovery, drug manufacturers appear

reluctant to initiate the lengthy, and potentially costly, discovery process.47 Estimates indicate that

the average time for a drug to reach approval in the United States ranges from 6 to 10 years.48

Some analysts question whether the PRV provides sufficient financial incentives for NTD

products.49 To date, only two companies have received the voucher, Novartis (for the drug

Coartem, which treats malaria) and Johnson and Johnson (for the drug Sirturo, which treats drugresistant TB). Novartis failed to see any market return on its voucher as it used the voucher for a

product whose new drug application failed to win FDA approval.50 Johnson & Johnson has not

yet used its voucher, which it earned in 2012. Some market analysts believe that the utility of the

voucher will remain uncertain until a PRV is sold and has a clear market value.51 It remains to be

seen whether the PRV, on its own, will provide a strong enough incentive to encourage drug

development.52 For example, in the development of Sirturo, Johnson and Johnson applied for a

PRV as well as two other FDA development incentives.53

Congressional interest in this issue may focus on the strategic investments that could spur added

drug treatments, vaccines, and diagnostic tools. For example, some might prioritize NTDs with

serious clinical outcomes that are difficult to treat and manage (e.g., Buruli ulcer, Chagas disease,

Judith Glassgold, former Specialist in Health Policy, contributed to this section.

P. Hotez et al., “Control of Neglected Tropical Disease,” New England Journal of Medicine, vol. 357, no 10, (2007),

pp. 1018-1027.

Global Challenges in Global Health, “New Approaches in Model Systems, Diagnostics, and Drugs for Specific

Neglected Tropical Diseases,” September 2012.

A.S. Robertson et al., “The Impact of the US Priority Voucher on Private Sector Investment in Global Health

Research and Development,” PLOS Neglected Tropical Diseases, vol. 6, no. 8 (August, 2012), pp. 1750-1755; P.

Trouiller et al., “Drug Development for Neglected Diseases: A Deficient Market and a Public-Health Failure,” Lancet,

vol. 359, no. 9324 (2002), pp. 2188-2194.

Ibid.

R. Stefanakis et al., “Analysis of Neglected Tropical Disease Drug and Vaccine Development Pipelines to Predict

Issuance of FDA Priority Review Vouchers over the Next Decade,” PLOS Neglected Tropical Diseases, October 25,

2012.

W. Noor, Placing Value on FDA’s Priority Review Vouchers,” In Vivo, vo. 27, no. 9, (September 2009),

http://www.imshealth.com/imshealth/Global/Content/Document/Placing_Value_on_FDA_Priorities.pdf; A.S.

Robertson et al., “The Impact of the US Priority Voucher on Private Sector Investment in Global Health Research and

Development,” PLOS Neglected Tropical Diseases, vol. 6, no. 8 (August, 2012), pp. 1750-1755.

A.S. Robertson et al., “The Impact of the US Priority Voucher on Private Sector Investment in Global Health

Research and Development,” PLOS Neglected Tropical Diseases, vol. 6, no. 8 (August, 2012), pp. 1750-1755.

Ibid.

A.S. Robertson et al., “The Impact of the US Priority Voucher on Private Sector Investment in Global Health

Research and Development,” PLOS Neglected Tropical Diseases, vol. 6, no. 8 (August, 2012), pp. 1750-1755.

Sirturo used the fast track program, PRV, and orphan-product designation. See http://www.fda.gov/NewsEvents/

Newsroom/PressAnnouncements/ucm333695.htm.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

human African trypanosomiasis, the leishmaniases, leprosy and yaws). Others might focus on

diseases that lack any drug treatment, such as dengue, or diseases that affect the greatest number

of individuals, such as STH. Vaccines do not exist for NTDs except for rabies, and diagnostic

measures are limited, so that vaccines could be prioritized. There is a case for developing

diagnostic tools for diseases that are difficult to detect, such as Buruli ulcer.54 Finally, another

potential investment could advance promising treatments that are already in development, such as

a vaccine for certain filarial infections (onchocerciasis and lymphatic filariasis).55

WHO, see http://www.who.int/mediacentre/factsheets/fs199/en/.

G. Dakshinamoorthy et al., “Multivalent Fusion Protein Vaccine for Lymphatic Filariasis,” Vaccine, vol. 31, no. 12,

(March 15, 2012), pp. 1616-1622; S. A. Babayan, J.E. Allen, and D.W. Taylor, “Future Prospects and Challenges of

Vaccines Against Filariasis,” Parasitic Immunology, vol. 34, no. 5 (May 2012), pp. 243-253.

Congressional Research Service

Appendix A. London Declaration: Table of Donor Commitments

Table A-1. London Declaration: Table of Donor Commitments

NTD Disease

Activity

Financial Commitment

Outline disease-specific goals and strategies for control and elimination

Multiple NTDs

World Health Organization (WHO)

Research and develop new programs and country-specific approaches for combating Guinea worm

disease, lymphatic filariasis, river blindness, schistosomiasis, blinding trachoma, visceral leishmaniasis

£195 million 2011-2015

U.K. Department for International

Development (DFID)

Maintain support in over 20 countries; expand support to include Mozambique, Senegal, Cambodia

Build on U.S. $301 million

investment since 2006

U.S. Agency for International

Development (USAID)

Overcome barriers to success to achieve the control and elimination of targeted NTDs by 2020

$363 million over five years

Bill and Melinda Gates Foundation

Expand work in NTD control and program enhancement

$5 million to selected sites in

the Americas and Africa

Mundo Sano

Country level: build stronger community health systems and integrate NTD elimination and control.

Regional level: oversee finances for trust fund to fight river blindness in Africa and partner with other

entities to expand trust fund to eliminate or control preventable NTDs in Africa

$120 million

World Bank

Apply WHO recommendations for implementing coordinated NTD plan

Brazil

Implement fully integrated, multi-sectoral NTD plan; reach full geographic coverage of all endemic

areas for lymphatic filariasis, STH, and schistosomiasis; map and reach full geographic coverage of

trachoma by 2018; build capacity for surveillance and action to sustain gains from PC

Mozambique

Implement integrated plan to control and eliminate NTDs

Tanzania

Implement integrated plan to control and eliminate NTDs

Bangladesh

Consider use of Ivermectin for other NTDs

Merck

Provide third parties, including Drugs for Neglected Diseases initiative (DNDi), access to selected

substances out of compound libraries to find new NTD treatments

Bayer

Provide third parties, including DNDi, access to selected proprietary compound libraries to develop

new medicines for certain NTDs

Bristol-Myers Squibb

Donate Azithromycin to a study on the potential for the drug to reduce mortality in young children

Pfizer

Mobilize resources from individual, foundation, and corporate donors to fund NTD treatments, fund

mapping initiatives, and fill programming gaps

CRS-15

Contributor

$30 million

END Fund

NTD Disease

Blinding

Trachoma

Chagas Disease

Guinea worm

disease

Leprosy

Lymphatic

Filariasis

Lymphatic

Filariasis and

Onchocerciasis

CRS-16

Activity

Financial Commitment

Contributor

Elimination of trachoma in China

$6.9 million

Pfizer

Continued donation of Azithromycin for blinding trachoma until at least 2020

$4 million

Lions Clubs International

Foundation

Elimination of trachoma in Commonwealth countries

$60 million

Queen Elizabeth Diamond Jubilee

Trust

Elimination of trachoma

$12 million

Conrad N. Hilton Foundation

Double existing annual donation of Nifurtimox to 1 million tablets through 2020

Bayer

Provide DNDi targeted access to proprietary compound libraries to develop new medicines

Abbot, AstraZeneca, Eisai,

GlaxoSmithKline, MSD, Novartis,

Pfizer, and Sanofi

Fill global funding gap

Gates Foundation ($23.3

million); DFID (£20million);

United Arab Emirates ($10

million); Children’s

Investment Fund Foundation

($6.7 million)

DFID, Gates Foundation, United

Arab Emirates, Children’s

Investment Fund Foundation

Extend existing donation of rifampicin, clofazimine, and dapsone through 2020 in quantities requested

by WHO

Novartis

Organize multi-stakeholder initiative to intensify leprosy control efforts

Novartis

Provide 120 million DEC tablets to WHO for its Global Lymphatic Filariasis Elimination program;

ensure a sufficient supply of DEC from 2012 through 2020

Gates Foundation, Eisai, and Sanofi

Donate 2.2 billion tablets of DEC from 2014-2020

Eisai

Maintain annual donation of 600 million tablets of Albendazole indefinitely

GlaxoSmithKline

Repurpose Flubendazole to kill adult worms associated with lymphatic filariasis and river blindness;

conduct drug reformulation studies; provide expertise for pre-clinical development and provide

technical and supply assistance. If pre-clinical development is successful, Johnson & Johnson will cofund clinical development; obtain regulatory approval; provide technical support

Abbot, DNDi, Johnson & Johnson,

Pfizer

Provide DNDi with access to proprietary compound libraries to develop new medicines that kill adult

worms associated with lymphatic filariasis and river blindness

AstraZeneca, Johnson & Johnson,

Novartis, Sanofi

NTD Disease

Activity

Financial Commitment

Increase annual donation of Praziquantel from 25 million to 250 million tablets/year indefinitely

Contributor

Merck KGaA

Develop child-friendly formulation of Praziquantel

Onchocerciasis

End onchocerciasis transmission in Cameroon

River Blindness

Maintain unlimited donation of Ivermectin indefinitely

MSD

Schistosomiasis

Provide financial support for a WHO school-based schistomiasis program

Merck KGaA

Extend existing donations of related treatments through 2020

Sanofi

Extend existing donations of related treatments through 2020

Bayer

Provide DNDi with access to proprietary compound libraries to develop new medicines

Abbot, AstraZeneca, Eisai,

GlaxoSmithKline, MSD, Novartis,

Pfizer and Sanofi

Partner with DNDi to develop a new oral drug candidate for sleeping sickness

Sanofi

Human African

Trypanosomiasis

$1 million

Lions Club International Foundation

Logistical support to ensure drugs reach patients at point of care free of charge

Soil-Transmitted

Helminthiases

Visceral

Leishmaniasis

CRS-17

Extend donation of 400 million Albendazole tablets/year through 2020

GlaxoSmithKline

Extend donation of 200 million Mebendazole tablets/year to 2020

Johnson & Johnson

Support programs, partnerships, and research to address intestinal worms

$120 million and technical

assistance

Global Partnership for Education

Technical assistance to national deworming programs, including improved monitoring and

evaluation and operational research aimed at exploring the possibility of elimination beyond 2020

$50 million

Children’s Investment Fund

Foundation

Explore the feasibility of blocking transmission and mitigating the risks of drug resistance, as well

as helping build the evidence base for effective cross-sector approaches

$50 million

Gates Foundation

Test strategies in partnership with local governments for deworming and combination treatments,

$8 million

particularly in the Americas

Mundo Sano

Scale up deworming with vitamin A distributions and provide implementation support through

local partners to eligible pre-school children

Vitamin Angels

Provide DNDi with access to proprietary compound libraries to develop new medicines

$4.5 million

Abbot, AstraZeneca, Eisai, Novartis,

Pfizer, Sanofi, GlaxoSmithKline, and

MSD

NTD Disease

Activity

Financial Commitment

Contributor

Partner with DNDi to transform drug currently in trials for Chagas Disease as a new treatment for

leishmaniasis

Eisai

Donate AmBisome for 50,000 patients in South Asia and East Africa from 2012-2017; continue

program to offer VL at cost; investigate and invest in technologies and process to reduce cost of

Ambisone in resource-limited countries

Gilead

Develop new training tools for leishmaniasis care for health care providers and patients

Sanofi

Source: Adapted by CRS from Uniting to Combat Neglected Tropical Diseases, Table of Commitments, January 30, 2012, http://www.unitingtocombatntds.org/

downloads/press/ntd_event_table_of_commitments.pdf.

CRS-18

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Appendix B. Map of USAID NTD Program

Figure B-1. NTD Program Countries

Source: Adapted by CRS from USAID website on NTDs, http://www.neglecteddiseases.gov/countries/index.html, May 29, 2014.

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Figure B-2. Deworming Treatment Access Trends: 2003-2012

Source: Created by CRS from WHO, “Soil-Transmitted Helminthiases: Number of Children Treated in 2012,”

Weekly Epidemiological Record, (March 28, 2014), Volume 13, Number 89, pp. 133-140.

Notes: Coverage refers to the percent of people who are in need of treatment who receive it.

Acronyms: lymphatic filariasis (LF).

Congressional Research Service

U.S. and Global Progress in Combating Neglected Tropical Diseases (NTDs)

Author Contact Information

(name redacted)

Specialist in Global Health

[redacted]@crs.loc.gov, 7-....

Congressional Research Service

EveryCRSReport.com

The Congressional Research Service (CRS) is a federal legislative branch agency, housed inside the

Library of Congress, charged with providing the United States Congress non-partisan advice on

issues that may come before Congress.

EveryCRSReport.com republishes CRS reports that are available to all Congressional staff. The

reports are not classified, and Members of Congress routinely make individual reports available to

the public.

Prior to our republication, we redacted names, phone numbers and email addresses of analysts

who produced the reports. We also added this page to the report. We have not intentionally made

any other changes to any report published on EveryCRSReport.com.

CRS reports, as a work of the United States government, are not subject to copyright protection in

the United States. Any CRS report may be reproduced and distributed in its entirety without

permission from CRS. However, as a CRS report may include copyrighted images or material from a

third party, you may need to obtain permission of the copyright holder if you wish to copy or

otherwise use copyrighted material.

Information in a CRS report should not be relied upon for purposes other than public

understanding of information that has been provided by CRS to members of Congress in

connection with CRS' institutional role.

EveryCRSReport.com is not a government website and is not affiliated with CRS. We do not claim

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.