U.S. GOVERNMENT PUBLISHING OFFICE

30–710PDF WASHINGTON : 2018

COMBATING TUBERCULOSIS IN SOUTHERN AFRICA

HEARING

BEFORE THE

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, 

GLOBAL HUMAN RIGHTS, AND 

INTERNATIONAL ORGANIZATIONS

OF THE

COMMITTEE ON FOREIGN AFFAIRS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED FIFTEENTH CONGRESS

SECOND SESSION

JULY 12, 2018

Serial No. 115–156

Printed for the use of the Committee on Foreign Affairs

(

Available: http://www.foreignaffairs.house.gov/, http://docs.house.gov,

or http://www.gpo.gov/fdsys/

(II)

COMMITTEE ON FOREIGN AFFAIRS 

EDWARD R. ROYCE, California, Chairman 

CHRISTOPHER H. SMITH, New Jersey 

ILEANA ROS-LEHTINEN, Florida 

DANA ROHRABACHER, California 

STEVE CHABOT, Ohio 

JOE WILSON, South Carolina 

MICHAEL T. MCCAUL, Texas 

TED POE, Texas 

DARRELL E. ISSA, California 

TOM MARINO, Pennsylvania 

MO BROOKS, Alabama 

PAUL COOK, California 

SCOTT PERRY, Pennsylvania 

RON DESANTIS, Florida 

MARK MEADOWS, North Carolina 

TED S. YOHO, Florida 

ADAM KINZINGER, Illinois 

LEE M. ZELDIN, New York 

DANIEL M. DONOVAN, JR., New York 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

ANN WAGNER, Missouri 

BRIAN J. MAST, Florida 

FRANCIS ROONEY, Florida 

BRIAN K. FITZPATRICK, Pennsylvania 

THOMAS A. GARRETT, JR., Virginia 

JOHN R. CURTIS, Utah 

ELIOT L. ENGEL, New York 

BRAD SHERMAN, California 

GREGORY W. MEEKS, New York 

ALBIO SIRES, New Jersey 

GERALD E. CONNOLLY, Virginia 

THEODORE E. DEUTCH, Florida 

KAREN BASS, California 

WILLIAM R. KEATING, Massachusetts 

DAVID N. CICILLINE, Rhode Island 

AMI BERA, California 

LOIS FRANKEL, Florida 

TULSI GABBARD, Hawaii 

JOAQUIN CASTRO, Texas 

ROBIN L. KELLY, Illinois 

BRENDAN F. BOYLE, Pennsylvania 

DINA TITUS, Nevada 

NORMA J. TORRES, California 

BRADLEY SCOTT SCHNEIDER, Illinois 

THOMAS R. SUOZZI, New York 

ADRIANO ESPAILLAT, New York 

TED LIEU, California

AMY PORTER, Chief of Staff THOMAS SHEEHY, Staff Director

JASON STEINBAUM, Democratic Staff Director 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND

INTERNATIONAL ORGANIZATIONS

CHRISTOPHER H. SMITH, New Jersey, Chairman 

MARK MEADOWS, North Carolina 

DANIEL M. DONOVAN, JR., New York 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

THOMAS A. GARRETT, JR., Virginia 

KAREN BASS, California 

AMI BERA, California 

JOAQUIN CASTRO, Texas 

THOMAS R. SUOZZI, New York 

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C O N T E N T S 

Page

WITNESSES 

Rebecca Martin, Ph.D., Director, Center for Global Health, U.S. Centers for 

Disease Control and Prevention ......................................................................... 4

The Honorable Deborah L. Birx, M.D., U.S. Global AIDS Coordinator, U.S. 

Special Representative for Global Health Diplomacy, U.S. Department of 

State ...................................................................................................................... 11

Ms. Irene Koek, Senior Deputy Assistant Administrator, Global Health Bureau, U.S. Agency for International Development ............................................ 20

LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING 

Rebecca Martin, Ph.D.: Prepared statement ......................................................... 6

The Honorable Deborah L. Birx, M.D.: Prepared statement ............................... 13

Ms. Irene Koek: Prepared statement ..................................................................... 22

APPENDIX 

Hearing notice .......................................................................................................... 44

Hearing minutes ...................................................................................................... 45

The Honorable Christopher H. Smith, a Representative in Congress from 

the State of New Jersey, and chairman, Subcommittee on Africa, Global 

Health, Global Human Rights, and International Organizations: 

Statement of the Honorable Eliot L. Engel, a Representative in Congress 

from the State of New York ............................................................................. 46

Statement of the American Thoracic Society ..................................................... 48

Written responses from the witnesses to questions submitted for the record 

by: 

The Honorable Eliot L. Engel, a Representative in Congress from the State 

of New York ...................................................................................................... 54

The Honorable Ami Bera, a Representative in Congress from the State 

of California ...................................................................................................... 60

The Honorable Joaquin Castro, a Representative in Congress from the 

State of Texas ................................................................................................... 73

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COMBATING TUBERCULOSIS IN SOUTHERN 

AFRICA 

THURSDAY, JULY 12, 2018

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH,

GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS,

COMMITTEE ON FOREIGN AFFAIRS,

Washington, DC. 

The subcommittee met, pursuant to notice, at 3:00 p.m., in room 

2255 Rayburn House Office Building, Hon. Christopher H. Smith 

(chairman of the subcommittee) presiding. 

Mr. SMITH. The subcommittee will come to order, and good afternoon to everyone. Thank you for being here. 

Today’s hearing will address the persistent and too often underestimated threat to global public health posed by tuberculosis. This 

brutal contagious disease killed 1.7 million people in 2016—the 

most recent data available—making it the deadliest infectious disease in the world, killing more than both HIV/AIDS and malaria 

combined. 

TB is devastating for many people globally but it impacts the 

people of Africa, especially southern Africa, disproportionately. 

In 2016, 44 percent of all TB deaths occurred in the Africa region, in spite of accounting for only 25 percent of all new TB cases. 

Africans die at a rate of 72 per 100,000 infected, compared with 35 

per 100,000 in Southeast Asia and 13 per 100,000 in the eastern 

Mediterranean region. 

Those infected with HIV/AIDS are particularly vulnerable to TB 

and nearly three-quarters of those co-infected with HIV and TB in 

2016 lived in sub-Saharan Africa. 

Thankfully, most cases of TB are curable if patients are diagnosed and adhere to a proper treated regimen. However, millions 

of newly-infected people go undiagnosed and without treatment 

each year, and the global spread of multiple drug resistant, or 

MDR, or extensively drug resistant—XDR TB—which emerges 

when patients receive inappropriate or incomplete treatment, poses 

and even greater and more costly threat. 

In 2016, roughly, 490,000 people develop MDR TB. An additional 

110 new cases were resistant to the most effective treatment. Not 

only is treating MDR and XDR TB a grueling process for the patient, it also costs far more to treat than the other manifestation 

of the disease. 

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One study by the Stop TB Partnership estimated that drug-resistant TB could kill up to 2.5 million people annually and cost the 

global economy $16.7 trillion if left unchecked. 

The dangerous potential of a drug-resistant TB outbreak is evident in the South African mining sector where exposure to silica 

dust, crowded poor living conditions, and high HIV prevalence created an incubator for disease and heightened the risk of contracting TB. 

Further complicating the problem, approximately 40 percent of 

mine workers are migrants who frequently move across borders 

and don’t receive consistent medical treatment from public health 

systems in the region that do not coordinate sufficiently. 

This further increases the risk of MDR and XDR TB infections. 

I am encouraged to see that U.S. funding for combating TB in- creased to $261 million in 2018, which is $20 million more than 

was allocated in 2017, and more than $82 million higher than the 

administration’s request. 

This shows that my colleagues and I and all of us are taking this 

threat seriously and I think that is a positive step on our part. 

But we must not stop there or become complacent in any way. The World Health Organization anticipates a $7.4 billion budget 

shortfall for the global plan to end TB if the international community does not significantly increase funding. 

We must encourage our international partners to step up to this 

challenge and take the opportunity of the U.N. General Assembly 

high level meeting on ending TB this September to do so. 

But even more, we must explore more innovative and holistic approaches to eliminating this disease. We must work from a regional 

perspective and increase coordination among health systems. 

We must pay special attention to the mines in South Africa. We 

must redouble our efforts to diagnose and treat every person infected with TB and we must pull out all the stops when it comes 

to preventing MDR or XDR TB infections. 

We must also encourage the World Health Organization to stop 

being overly bureaucratic when it comes to battling TB. There are 

bottlenecks in the WHO approval process for new treatments and 

new diagnostic tests which need to be fixed. 

I am looking forward to hearing from our very distinguished 

panel, which I’ll introduce shortly. I would like to welcome Tommy 

and Amanda Russo, distinguished guests who are here visiting, 

and their parents from Howell Township in my district. 

Thank you for coming, Tommy and Amanda, and I would like to 

yield to my good friend and colleague, the ranking member, Ms. 

Bass. 

Ms. BASS. Thank you, Mr. Chairman. 

I want to thank you for convening today’s hearing on combating 

tuberculosis in southern Africa. We know this is an issue that is 

important to all of us with global dimensions that impact everyone. 

I want to thank our witnesses for taking the time to testify before this committee today. We know that you have dedicated your 

life to addressing the great public health challenges and we thank 

you. 

I also want to thank Ranking Member Engel, who might be here. 

He has consistently championed several health priorities and, in 

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particular, the spread of tuberculosis, both multi-drug resistant 

and extensively drug resistant TB. 

In 2016, 25 percent of all new TB cases developed in Africa and 

2.5 million people—44 percent of all TB deaths—occurred in the region. Meanwhile, we know that TB cases are both preventable and 

curable. 

But we are here today because the southern African region has 

the highest incidence of TB in the world. The association with 

HIV/AIDS and co-infection has made TB one of the leading killers 

of HIV/AIDS-positive people globally, and southern Africa has one 

of the highest burdens of TB and the highest burdens of HIV. 

Defeating TB requires expanding access to affordable treatment 

but also prevention of TB in the first place. 

I look forward to hearing on how the U.S. is supporting more effective treatment as well as prevention. 

Thank you. 

Mr. SMITH. Thank you, Ranking Member. 

I now would like to introduce our distinguished panel, beginning 

first with Dr. Rebecca Martin, who is the director of the Center for 

Global Health at the U.S. Centers for Disease Control and Prevention, CDC. 

With over 18 years of experience working with immunization, 

HIV, and health system strengthening, Dr. Martin is a leading expert in the field of international health. 

She has worked extensively in Africa to measure and evaluate 

the HIV/AIDS epidemic and equip nations to respond effectively. 

As director of the Center for Global Health, Dr. Martin leads the 

CDC’s global effort to protect and improve health globally through 

science, policy, partnership, and evidence-based health action. We 

are delighted that she is here today to provide her expert insights. 

Ambassador Deborah Birx, a medical doctor, is the coordinator 

for the United States Government Activities to Combat HIV/AIDS 

and U.S. Special Representative for Global Health Diplomacy. 

Over her 30-year career, she has focused on HIV immunology, 

vaccine research, and global health. Ambassador Birx oversees the 

implementation of the U.S. President’s Emergency Plan for AIDS 

Relief, or PEPFAR, and all U.S. Government engagement with the 

Global Fund to fight AIDS, tuberculosis, and malaria. 

In her role as U.S. Special Representative for Global Health Diplomacy, she works to align the U.S. Government’s diplomacy with 

foreign assistance programs and address global health challenges 

and move toward achieving goals, including eliminating AIDS, ending preventable child and maternal deaths, and combating infectious disease threats. 

We will then hear from Irene Koek, who is the senior deputy assistant administrator in USAID’s Global Health Bureau. Previously, she was the senior infectious disease advisor for the Global 

Health Bureau and the Global Health Security Agenda led at 

USAID. 

From 2010 to 2014, she was director of the Health Office in 

USAID Indonesia, where she also served as the health attache and 

PEPFAR coordinator. During her 32-year career with USAID, Ms. 

Koek has also worked as a health advisor to the Policy and Program Coordination Bureau, and as chief of infectious disease diviVerDate 0ct 09 2002 08:41 Sep 25, 2018 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 Z:\WORK\_AGH\071218\30710 SHIRL
4

sion in the Global Health Bureau helped start the President’s malaria initiative and served as chair of the Stop TB coordinating 

board. 

Ms. Koek, thank you for being here as well, and without objection, your full resumes will be made a part of the record. 

Dr. Martin, the floor is yours. 

STATEMENT OF REBECCA MARTIN, PH.D., DIRECTOR, CENTER 

FOR GLOBAL HEALTH, U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION 

Ms. MARTIN. Thank you, Chairman Smith and Ranking Member 

Bass. 

My name is Dr. Rebecca Martin and I serve as the director for 

the Center for Global Health within the U.S. Centers for Disease 

Control and Prevention. 

I appreciate the opportunity to be here today to discuss the global health security threat of drug resistant tuberculosis and CDC’s 

critical role in preventing and stopping it. 

It is a pleasure to join my friends and colleagues, Ambassador 

Birx and Deputy Assistant Administrator Koek. 

In 1973, my older sister was exposed to TB and infected and had 

to undergo 9 months of treatment, a practice still valid today in 

many countries, nearly 50 years later. 

In 1991, I worked in Haiti to set up a cutting-edge laboratory for 

TB with fluorescent microscopy, still in use nearly 30 years later 

in resource-constrained countries. 

HIV drives the TB epidemic in southern Africa with the co-infection rate of 60 percent. While we have benefitted from innovations 

to fight HIV, innovations for TB have not kept pace. We must fight 

these two diseases together. 

I want to emphasize three points about CDC’s work in combatting TB. First, CDC leads the U.S. domestic TB program that supports states and large cities, and conducts clinical and epidemiologic and laboratory public health research. 

Our success in domestic elimination is dependent upon our work 

in global TB. 

Secondly, a disease threat anywhere is a disease threat everywhere, and there is no greater example than this than drug-resistant TB. 

Thirdly, to succeed in controlling TB, we need to develop new 

tools, scale up existing tools in prevention, and enhance political 

will. 

Today, tuberculosis, although preventable and treatable, is the 

world’s leading infectious disease killer, taking the lives of nearly 

1.7 million people each year. 

Over 25 percent of these deaths occurred in Africa in 2016 with 

southern Africa as the epicenter. One-quarter of the world’s population—nearly 2 billion—is infected with TB. 

Among those individuals who become ill with TB disease, approximately 4 million go undiagnosed and untreated. TB drug resistance first develops when patients receive incomplete or inadequate treatment. 

Drug-resistant TB can then spread from person to person, making the disease an even greater threat to global health security. 

5

Globally, in 2016, there were 600,000 new TB cases resistant to 

first line drugs and 80 percent of them were resistant to multiple 

drugs. 

Drug resistant infections are extremely costly to treat and manage, cause intense suffering, strain fragile health systems, and result in death at much higher rates than drug-susceptible TB, with 

only one in 10 being cured to date. 

A hundred and five countries, including the United States, have 

also reported cases of extensively drug-resistant TB, an even more 

severe form of the disease, which is at least 17 times more expensive to treat than medication-responsive TB strains. 

I want to talk for a moment about the connection between CDC’s 

global and domestic TB efforts. Over the past two decades, TB 

cases in the United States have decreased by 75 percent, and U.S. 

now has one of the lowest cases in the world. 

Yet, there is still work to be done here and abroad. People born 

outside the U.S. make up 70 percent of the total TB cases in the 

U.S. Nearly all of these people arrived in the U.S. over 10 years 

ago. 

To control TB and prevent drug resistance in the United States, 

we must work outside of our borders. For example, CDC works 

with our counterparts—ministries of health—in more than 25 countries to combat TB, including those countries from which most U.S. 

TB cases originate. 

In South Africa, CDC has used molecular fingerprinting to determine that multi-drug-resistant TB cases were primarily due to person-to-person spread and not due to problems adhering to treatment regimens. 

Also, CDC is a co-lead in addressing TB-HIV co-infection in high 

burden countries through PEPFAR. Despite recent success, stopping TB will require that we scape up access to existing tools and 

redouble our efforts to develop the next generation of drugs and 

technologies to accelerate our impact. 

Importantly, expanding TB-preventive therapy, which is up to 90 

percent effective in protecting people with latent TB infection from 

progressing to active disease could change the trajectory of the TB 

epidemic. 

In the coming years, continued U.S. leadership will be essential 

to eliminating TB domestically and in the international community 

mobilizes to address this threat. 

We have an opportunity to demonstrate our leadership at the upcoming United Nations General Assembly in September and we 

need champions like the Honorable Minister Motsoaledi, who could 

not be here with us today, and each of you. 

In closing, I’d like to leave you with a quote from Nelson 

Mandela, who said, ‘‘It always seems impossible until it’s done.’’

At CDC, we embrace the impossible. 

Thank you for the opportunity to appear before you today and I 

look forward to answering your questions. 

[The prepared statement of Ms. Martin follows:]

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HEARING TESTIMONY 

House Foreign Affairs Committee 

Subcommittee on Africa, Global Health, Human Rights, & International Organizations 

The Threat of Drug-Resistant TB in Southern Africa 

Dr. Rebecca Martin, Director, Center for Global Health, Centers for Disease Control & Prevention 

Chairman Smith, Ranking Member Bass, and members of the Subcommittee-my name is Dr. Rebecca 

Martin, and I serve as the Director of the Center for Global Health within the Centers for Disease 

Control and Prevention (CDC). Thank you very much for the opportunity to be here today to discuss the 

global threat of drug-resistant tuberculosis (TB) and CDC's critical role in the fight against this deadly 

epidemic. 

Tuberculosis and the Scourge of Drug-Resistant TB 

Tuberculosis is a disease caused by the bacterium Mycobacterium tuberculosis, which spreads from 

person to person through the air. As TB disease progresses, it attacks the lungs and can damage the 

brain, kidneys, and spine. TB can lead to premature death if untreated. 

Despite being preventable and treatable, TB has surpassed HIV/AIDS as the world's leading infectious 

disease killer, taking the lives of 1.7 million people each year. TB is also the leading cause of death 

among people living with HIV. One quarter of the world's population- nearly 2 billion people- is 

infected with TB bacteria, and over 10 million of these latent infections progress to active TB disease 

each year and become transmissible. Among individuals who become ill with TB, approximately four 

million people go undiagnosed and untreated, allowing further transmission. 

TB drug resistance develops when patients receive incomplete or inadequate treatment. Treatment of 

drug-susceptible TB requires at least six months of treatment with four different antibiotics. This 

regimen was developed to assure that all the bacteria in the person's system are killed. However, if this 

regimen is interrupted, only some of those TB bacteria are killed. Other TB bacteria are able to 

withstand the partial treatment and continue to grow. Patients whose treatment is not completed can 

relapse, die, or develop drug-resistant strains of bacteria that can then be transmitted to others. 

CDC is focused on drug-resistant TB as a leading health security threat to the U.S. and countries around 

the world. The World Health Organization (WHO) estimates there were 600,000 new cases with 

resistance to first-line drugs in 2016, of which 490,000 cases were multi-drug resistant (MDR). A total 

of 105 countries, including the United States, have reported cases of extensively drug-resistant (XDR) 

TB, an even more severe form of the disease. Drug-resistant infections are extremely costly to treat 

and manage, cause intense suffering, strain already fragile health systems, and results in mortality at 

much higher rates than drug-susceptible TB. TB drug resistance accounts for approximately 30 percent 

of all antimicrobial resistance worldwide. 

CDC's Role in Combating TB 

CDC is a leader in the fight against TB in the U.S. and around the globe. Our efforts to combat TB are 

helping to ensure a safer America and a safer world. CDC leads the U.S. national TB program, providing 

technical and financial support to all state TB programs, and conducting clinical 1 epidemiologic and 
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laboratory research. Findings from this research influence treatment, diagnostics, programs, and 

laboratory services throughout the world. CDC's domestic investment in TB elimination protects 

Americans' health. Over the past two decades, TB case rates in the United States decreased by 75 

percent, and the U.S. now has one of the lowest case rates in the world. Despite these gains, we still 

have tremendous work ahead. 

To eliminate TB in the United States we must work outside of our borders to control TB and prevent 

drug-resistance. People born outside the U.S. rnake up 70 percent of the total TB cases in the United 

States-nearly all of these people came to the U.S. with the bacteria that cause TB living inside them 

but not causing illness. 

CDC works with the State Department to ensure that licensed, and experienced medical doctors 

practicing overseas screen and treat immigrants and refugees for active TB, according to CDC 

guidelines, and are cured, before entry into the United States. Under the authority of the Immigration 

and Nationality Act {INA), the CDC provides the technical instructions for the required medical 

screening exam. The INA defines medical conditions for inadmissibility, which by regulation, include TB. 

Globally, CDC works to find, cure, and prevent TB worldwide, through on-the-ground interventions and 

global leadership in operational research and technical expertise. CDC works to improve basic TB 

prevention and infection control efforts to break the cycle of transmission and prevent drug resistance. 

We are developing innovative approaches to find and treat the roughly 4 million people each year who 

develop TB disease and go undiagnosed, unreported, or inappropriately treated. Our experts 

strengthen lab networks and surveillance systems for faster and more accurate diagnosis, and we assist 

health facilities to implement best practices to end TB transmission. CDC also conducts operational 

research to identify better, less toxic treatment regimens that cure patients faster and invests in 

understanding epidemiological factors that drive the spread ofTB, HIV-associated TB, and MDR TB. In 

addition, CDC conducts clinical, epidemiologic, and laboratory research that has led to safer, more 

effective latent TB regimens, improved tests for latent TB infection, and better methods of detection of 

drug resistance. 

CDC works closely with ministries of health through strong, peer-to-peer working relationships. We 

work with countries that are most directly connected to our domestic TB epidemics, and we help to 

strengthen their national TB programs and reduce their TB burden. These global efforts protect U.S. 

citizens from TB transmission domestically and during travel to foreign countries. 

CDC is also a lead implementer of programs to address TB/HIV co infection in high-burden countries 

through the U.S. President's Emergency Plan for AIDS Relief (PEP FAR). We provide HIV testing to TB 

patients and support HIV treatment for people living with HIV/TB co-infection, whose weakened 

immune systems make them more vulnerable to becoming ill from TB. CDC works in more than 25 

countries to combat TB, including ten PEP FAR Priority Countries that account for 80 percent of HIV/TB 

treatment. In Kenya, India, Mexico, China, and Vietnam, CDC has TB experts in CDC country offices to 

provide direct technical assistance to governments. 

CDC's Collaboration across U.S. Agencies and International Organizations 
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Globally, fewer than one in five people with MDR TB receive the drugs they need to combat the 

disease, and less than half of those that do are cured. CDC is a lead implementer of the National Action 

Plan for Combating Multidrug-Resistant Tuberculosis (NAP), which builds on the National Action Plan 

to Combat Antibiotic-Resistant Bacteria (CARB). CARB focuses on preventing the spread of resistant 

pathogens and includes activities to prevent the spread of MDR-TB around the world. The NAP is a 

five-year plan that builds on and contributes to the U.S. Government's domestic and global TB 

strategies, as well as the WHO's END TB Strategy. CDC supports, together with the U.S. Agency for 

International Development (USAID) and the National Institutes of Health (NIH), the three goals of the 

NAP: 1) Strengthening domestic capacity to combat MDR TB; 2) Improving international capacity and 

collaboration to combat MDR TB; and 3) Accelerating basic and applied research and development to 

combat MDR TB. 

CDC works closely with our interagency partners to implement PEPFAR and global TB initiatives. The 

U.S. Global TB Strategy focuses on the comparative advantages and strengths of all federal agencies to 

control TB globally. For example, CDC coordinates with USAID at headquarters and in the field to 

strengthen capacity to combat MDR TB in countries with the highest TB burden. In Uganda and other 

African countries, CDC strengthens national TB laboratory networks to diagnose TB and MDR TB. To 

accelerate basic and applied research and development to combat MDR TB, CDC works with USAID and 

the NIH to assess the effectiveness of therapeutic regimens combining licensed and novel drugs that 

may result in fewer serious side effects and shorter treatment durations for patients with MDR TB. 

U.S. Government agencies hold monthly Global TB Coordination teleconference calls to share 

information and plan collective approaches. CDC and USAID field teams also collaborate to support 

Global Fund TB grants. 

CDC's work supports and contributes to the WHO's END TB Strategy (2015-2035), the Stop TB 

Partnership's Global Plan to End TB (2016-2020), and the USG's Global TB Strategy (2015-2019). CDC 

collaborates with these technical organizations, ministries of health, the Global Fund to Fight AIDS, 

Tuberculosis and Malaria, and other U.S. agencies to find, cure, and prevent TB, HIV-associated TB, and 

drug-resistant TB. 

As a new frontier in the fight against TB, CDC focuses on expanding the use ofTB preventive therapy 

(TPT), which works by attacking latent TB bacteria before they can multiply to cause active disease, 

spread, and develop resistance. TPT can dramatically reduce latent TB cases, preventing TB disease and 

transmission. In people on TPT, it is 90 percent effective in protecting people with latent TB infection 

from progressing to TB disease. In the United States, more than 80 percent of active TB cases stem 

from reactivation of past latent TB infection. Therefore, expanding testing and treatment of persons at 

risk for latent TB infection, in addition to active case-finding and treatment, is key to eliminating TB. 

CDC is taking these evidence-based data and implementing programmatic changes to amplify public 

health impact. Through PEPFAR, CDC is leading the aggressive scale-up to more than triple access to 

TPT to prevent TB disease among people living with HIV in southern Africa and beyond. CDC also 

supports innovative operational research to improve diagnosis ofTB in persons living with HIV. 

CDC and TB in Africa 
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Africa remains a global TB hotspot. WHO reports that over 400,000 people died from TB in Africa in 

2016, representing nearly 25 percent of global TB deaths. South Africa, Mozambique, and Zimbabwe 

are among the highest burden countries in the world for drug-resistant TB. Africa lacks sufficient 

facilities to provide rapid diagnosis, care, and treatment to patients where they live, and high rates of 

HIV infection suppress immune systems and fuel TB transmission in all its forms. Mining and other 

cross-border seasonal work can interrupt TB treatment, leading to resistance and increasing 

opportunities for transmission. 

CDC works closely with ministries of health and other partners to scale-up existing tools. In Uganda, 

Mozambique, and Kenya, CDC is expanding access to rapid testing and rapid treatment by mapping 

access points for TB care. Through PEPFAR, CDC works to find and treat those with latent TB infection 

in Africa and deliver preventive therapy to interrupt the cycle of TB transmission. CDC works with 

several countries including Botswana, Ethiopia, Mozambique, Nigeria, Rwanda, Zambia, Zimbabwe, and 

Lesotho to implement innovative and effective TB infection control practices in healthcare settings. 

CDC partnered with Zimbabwe to implement a national policy for annual TB screening and treatment 

for all health care workers, which has reduced TB rates. 

In Zambia, Lesotho, and Mozambique, CDC is developing novel approaches to provide seasonal 

mineworkers and their families with diagnosis, care, and treatment services both at work and in home 

communities. To address the need for better, faster diagnostics and shorter, safer treatment regimens 

for drug-resistant TB, CDC is working through the AIDS Clinical Trial Group in South Africa to identify 

the best approach for preventing MDR TB among exposed children and family members. 

South Africa has been a pioneer in these efforts. CDC works closely with the Ministry of Health in South 

Africa to combat TB, and they have been a strong and effective partner. In 2006, an outbreak of XDR TB 

in KwaZulu-Natal devastated the state's population, demonstrating the catastrophic toll caused by 

drug-resistant strains. A ground-breaking study revealed that MDR TB spread from person-to-person in 

hospitals and did not emerge solely from incomplete drug regimens. The outbreak killed 52 of 53 

patients who developed TB disease, and we learned more about how easily drug-resistant TB spreads 

to persons living with HIV and we learned more about the transmissibility and high mortality of drug 

resistant TB among people living with HIV. Since this experience, South Africa has scaled up testing for 

drug resistance, tested new drug regimens to cure drug-resistant TB faster with fewer side effects, and 

implemented effective infection control programs in hospitals. Globally and in its own region, South 

Africa is leading by example to tackle the enormous challenges of these dual epidemics of HIV and TB. 

Momentum in the Fight against TB 

Infectious disease threats do not respect borders, so a disease threat anywhere is a threat everywhere. 

Like other infectious threats, TB (and especially drug-resistant TB) jeopardizes the health, security, and 

prosperity of America and our partners. 

The world has made great strides against TB- with more than 53 million lives saved since 2000- but 

we cannot win the battle against this disease unless we find more cases, expand access to diagnosis 

and treatment, stop transmission, and effectively prevent the development and spread of drug4 
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resistant TB. Further, we will not eliminate TB in the United States unless we control TB and prevent 

drug-resistance internationally. 

To do this, we must scale up access to the effective tools we have and redouble efforts to develop the 

next generation of technologies to accelerate our impact. Beyond this, we must look for new ways to 

hold ourselves and others accountable for progress, which can begin with an effective accountability 

framework-an independent mechanism to track commitments and progress for all nations. 

Political will is critical from every country combatting TB. As the Subcommittee is aware, heads of state 

will gather in September 2018 at the United Nations General Assembly for the first-ever high-level 

meeting on TB, which could lead to new commitments from countries and accelerate progress where it 

is needed most. The world is focused on the TB epidemic, and we must seize the moment together to 

halt this global threat in its tracks. 

Thank you for your support of CDC's global TB efforts, and I would be pleased to answer your 

questions. 
11

Mr. SMITH. Dr. Martin, thank you so very much. 

Dr. Birx. 

STATEMENT OF THE HONORABLE DEBORAH L. BIRX, M.D., U.S. 

GLOBAL AIDS COORDINATOR, U.S. SPECIAL REPRESENTATIVE FOR GLOBAL HEALTH DIPLOMACY, U.S. DEPARTMENT 

OF STATE 

Dr. BIRX. Thank you, Chairman Smith, Ranking Member Bass. 

Thank you for your continued incredible vision and support for 

PEPFAR and let me again thank your staff, who have been really 

instrumental in the work that we do every day, and to the rows 

behind me who are so extraordinarily dedicated for TB. There’s a 

lot of people in the audience today who are very much committed 

to our response globally to TB/HIV. 

I am not going to repeat many of the numbers that were just presented. If we can have the first graphic—I think, hopefully, shows 

you the absolute ramp up of both TB and HIV concomitantly in 

southern Africa. And so picking this as a focus of southern Africa 

was really brilliant because it shows if we control the HIV pandemic, we return to those much lower and we control the TB pandemic in southern Africa. 

Our goal in PEPFAR has always been to provide the best care, 

and part of that best care now requires us to dramatically expand 

our TB activities, which we have done over the last 2 years. 

We’ve invested about $1.5 billion within PEPFAR on TB and TB/

HIV but we are really focused on increasing and accelerating our 

impact. 

We’ve taken a three-prong approach. One is ensuring that all TB 

cases are tested for HIV and then those cases that are found to be 

dually infected start on HIV treatment immediately. 

We are also focused, number two, on preventing TB from developing in the first place in HIV positive clients and this is by treating them early before their immune system begins to deteriorate. 

Third, we are screening our HIV-infected clients for TB and ensuring that those who have active disease are treated immediately 

and those who don’t have active disease are immediately put on 

TB-preventive therapy, which is a new addition to our program 

with a clear indicator. 

In our first focus area, and, you know, at PEPFAR we always try 

to be honest with ourselves, so in the first focus area of ensuring 

that every TB client is tested for HIV. We are at about a 95 percent success rate in our most recent data, and in getting those individuals on treatment we are at a 95 percent success rate. 

This makes sense because TB clients are often seen frequently, 

and so missing that opportunity of getting them on HIV drugs 

would be inexcusable. 

In the second area, which is really preventing deterioration of 

the immune system, we haven’t done as well, and this is—really, 

we haven’t been able to prevent the new cases of TB because countries have been delayed in often starting immediate treatment. 

But through sub-Saharan Africa, with the leadership of our Ambassadors in countries and the leaderships of ministers of health, 

many countries have gone to what we call test and start. 

12

So upon immediate diagnosis of HIV they started on TB—started 

on HIV therapy. Allowing them to thrive and not transmit the 

virus but also preventing opportunistic infection and, therefore, TB. 

If we can see the next graphic, I wanted to be honest also with 

who we are missing. The blue bars are men, the green bars are 

women, divided by age groups. 

These are the impact surveys that we have in the field. This is 

a summary of seven countries in sub-Saharan Africa clearly showing that we are missing men between age zero and 34 and we are 

missing women between zero and 24. 

It makes sense because we implemented what we call B+, to ensure all women that are pregnant immediately have access to lifelong treatment about 4 years ago, and you can see that almost 

every woman over 25 has been diagnosed and is on treatment. 

It’s really missing the healthy individuals. We know when people 

are infected with HIV they have a long prodrome of asymptomatic 

where their immune system is constantly under destruction. 

If we can find them early when they are perceived to be healthy, 

we can prevent the consequences of these opportunistic infections. 

So we are very much dedicated to finding these missing healthy 

children, missing healthy men, and missing healthy women, long 

before their immune system deteriorates. 

If we are able to do this, we’ve created a community of practice 

that not only is strengthening the health system for everyone but 

also provides the platform to find other communicable, noncommunicable, and future disease threats in the communities because the 

communities will see themselves within the health system and 

health-seeking behavior. 

Our third area of focus—the early diagnosis and treatment of TB 

in our HIV positive clients is also slowly improving. 

We are now up to about 76 percent of our clients are screened 

for TB when they come in to our PEPFAR HIV clinics and that has 

been a big change over the last 2 years. 

Where we are failing our clients is taking the ones that have 

been screened negative for active disease and getting them what 

we call preventive therapy. 

We were in the single digits and we are beginning to make 

progress quarter over quarter as we measure our progress in that 

indicator. 

We are beginning to see a real impact from our joint efforts of 

combatting HIV and TB together. The death rates have, remarkably, declined and in Botswana, Namibia, and a whole series of 

countries who had gone to earlier treatment there’s been a dramatic decline in the number of TB cases. 

I really—if immediate therapy for anti-retro viral therapy is the 

cornerstone of PEPFAR, both the active TB case findings and the 

preventive therapy will be our capstone. 

And so although we are behind compared to our other areas of 

work, we are very much focused on these areas and we’d appreciate 

your attention to this critical issue for us. 

Thank you. 

[The prepared statement of Dr. Birx follows:]

13


30710a-1.eps

Written Testimony 

Ambassador-at-Large Deborah L. Birx, M.D. 

Coordinator of the United States Government Activities to Combat HIV/AIDS and 

U.S. Special Representative for Global Health Diplomacy 

House Foreign Affairs Committee 

Subcommittee on Africa, Global Health, Global Human Rights, and International 

Organizations 

"The Threat of Drug-Resistant TB in Southern Africa" 

July 12, 2018 

Thank you Chairman Smith, Ranking Member Bass, and other distinguished members of this 

Subcommittee. I am deeply honored to appear before the House Foreign Affairs Committee 

and your Subcommittee, which have provided such visionary leadership and remarkable 

support for the U.S President's Emergency Plan for AIDS Relief (PEPFAR) since its inception 

in 2003. Thank you very much for the opportunity to be here today to discuss global TB/HIV 

co-infection and PEPFAR's critical role in the fight against this deadly epidemic. 

It has been estimated that a quarter of the world's population is infected with Mycobacterium 

tuberculosis, the organism that causes TB disease. Infection precedes the development of TB 

disease, sometimes by decades, and is clinically latent Only about ten percent of infected 

people with functioning immune systems will develop active, symptomatic TB disease in their 

lifetimes. People whose immune systems are impaired from conditions like malnutrition and 

especially HIV infection are at particular risk of, and from, active TB disease. Persons living 

with HIV are 20-30 times more likely than people without HIV to develop TB disease, and when 

they do, they are much more likely to die. Your focus on this particular alignment of HIV and 

TB in Southern Africa is timely and critical for both diseases. In Africa, the prevalence of TB 

surged dramatically through the 1990s, driven by the HIV epidemic (see graphic). 
14


30710a-2.eps

:;; 900 

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6 30 

~ 700 :; 25 8:' 

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- TB incide nee Antenatal HIV seroprevalenc.-e 

Churchyard et al, "Tuberculosis control in South Africa: successes, challenges and 

recommendations." South African Medical Journal; 2014 

In Southern Africa, the two diseases are so entwined that they are best considered as a 

syndemic- synergistically interacting epidemics, each worsening the other. In some 

communities in Africa with high burdens of HIV, rates of TB are literally hundreds of times 

higher than they are in the United States. 

In 2016 alone, an estimated 2.5 million people in Africa developed TB disease, 30 percent of 

whom were HIV infected, resulting in an estimated 764,000 new cases of TB among persons 

living with HIV. TB is also a relentless killer of persons with HIV; it is the leading cause of 

hospitalization, and far and away the leading cause of death, responsible for approximately 40 

percent of deaths in people with HIV. In Africa in 2016, there were almost 417,000 TB deaths, 

320,000 of which were in persons with HIV. HIV patients are more likely to have extrapulmonary TB, which is often harder to diagnose, and more likely to develop resistance to TB 

drugs, which makes TB extremely difficult to treat. The TB case fatality ratio is approximately 

20 percent in most African countries- many times higher than in Europe and the United 

States. This is particularly concerning since we have the tools we need to cure and prevent 

TB- which means that those deaths arguably could have been avoided. 

The persistent incidence and mortality of TB disease highlights two things: that TB remains an 

urgent public health concern in Africa and that we haven't yet done enough. Our goal is to 

provide the best care possible for our patients living with HIV and we are focused in three 

areas: (1) ensuring all TB cases are tested for HIV and treated for both infections, (2) 

preventing TB from developing in our HIV-infected clients by ensuring they are treated for HIV 

before their immune system deteriorates, and (3) screening our HIV infected clients for TB and 
15


30710a-3.eps

curing them when they are diagnosed or ensuring that they are given a course of TB 

preventive therapy. These efforts will interrupt transmission, lower TB prevalence, and help 

end this epidemic. In regions of the world where TB and HIV are tied together, HIV programs 

play a pivotal role in implementing the strategy to reduce TB through these focused 

interventions. As I will discuss, PEPFAR has committed to addressing TB in Africa by 

dramatically increasing HIV/TB investments and activities over the past decade and more 

recently by aggressively scaling up antiretroviral therapy for all persons living with HIV and 

accelerating the roll-out of TB preventive therapy. 

Since 2005, PEP FAR has invested over 1.5 billion dollars on TB/HIV programming, and as a 

result, PEPFAR-supported countries around the world have made substantial gains in TB 

control. So let's review our progress. In focus area (1), testing all TB patients for HIV and 

ensuring rapid initiation of antiretroviral therapy for those that test positive, we are doing well. 

This intervention dramatically lowers the risk of death and has been a focus of PEPFAR for 

several years. In PEP FAR-supported countries in the second quarter of FY 2018, the 

proportion of TB patients with documented HIV status was approximately 95 percent, and the 

proportion of those with H IV infection who were started on ART exceeded 95 percent. 

In focus area (2), ensuring everyone is begun on antiretroviral treatment immediately upon 

diagnosis to prevent the destruction of their immune system and prevent opportunistic 

infections including TB, we have not done as well- and this has been a core focus of the 

program over the past 2 years While finding and curing TB in our patients is a critical 

strategy, preventing TB from developing in the first place is the ultimate goal. Providing 

antiretroviral therapy to all HIV-infected patients before impairment of their immune systems is 

the single most impactful intervention possible: antiretroviral therapy for those that are HIV 

infected bolsters the immune system and reduces the risk of developing TB disease by about 

65 percent, and it reduces mortality in those who already have the disease. We have seen 

that Option B+ - antiretroviral therapy for expectant mothers- when offered to all pregnant 

women, regardless of CD4 cell count, dramatically reduced the risk of TB reactivation and 

death in women. Clinical trial and modeled data strongly suggest that wide-scale 

implementation of antiretroviral therapy will sharply reduce TB incidence and transmission in 

communities with high burdens of both diseases. Early antiretroviral therapy also protects 

communities by decreasing both HIV and TB transmission within those communities. By 

lowering the number of hospitalizations and preventing deaths, we are preserving the integrity 

and economic capacity of families and communities. 

We constantly seek more accurate data, at national and sub-national levels, to better track our 

progress and more precisely identify and address the key gaps and obstacles. We have 

conducted comprehensive community-level impact surveys (PHIAS) to better understand the 

gaps in achieving our goals, as demonstrated in this graphic below: 
16


30710a-4.eps

Progress and S Towards Epidemic on rol : 

Who is and who isn't virally suppressed 

100 

70 

lO 

10 

10 

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-

l n 

I ' I I I I 

1~ '~ 

~ !li 

'~9 

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" 

' 

! ---- L- ----- '----

(1...14 15-lot 25-34 35-44 45-59 0-U 15-24 25-34 :!5-44. 45-59 

111¥ir<~llySuppreSllt!rt itii1l% VLS :: ~OIJo/,: 'iLS 

"Pook?d data from Lesotho, Mala,"! NRmrb1a, Swazrland Tanzama, Uganda, Zambra and Zimbabwe 

n-c,nPHIAprojeGIS 

We are missing HIV-positive individuals among males 0-34 years old and females 0-24- these 

are mostly "healthy" individuals infected with HIV, but the virus is quietly destroying their 

immune system and if we don't find and treat them now, early in their disease, they will present 

later, sick with opportunistic infections, including TB. This is a core focus of the PEP FAR 

program; if we meet this challenge, stable health systems in Africa and health-seeking 

behaviors of communities will follow, Such systems and behaviors are needed to combat all 

the non-communicable diseases and ensure early identification of new infectious diseases and 

zoonotic events (critical for the global health security agenda) will be there. 

Scaling up antiretroviral therapy is the cornerstone of PEPFAR's TB/HIV efforts, and for the 

past two years, we have been insisting that programs start antiretroviral therapy in all people 

living with HIV (PLHIV) as soon as possible after confirmation of HIV status, regardless of CD4 

cell count This Test and Start policy is now the standard of care, and we are aggressively 

pursuing implementation of this policy and practice in all countries where we work, 

We are seeing the effects of the scale-up, Rates of TB increased starkly across Africa after 

HIV exploded in the 1990s; we are now seeing the reverse of this trend the World Health 

Organization has reported falling TB incidence as antiretroviral therapy is expanded where 

there is a high dual burden, and published data from Eswatini, Kenya, and Malawi clearly show 

decreases in new TB cases in the areas where HIV scale-up has been most effective. The 

effect of antiretroviral therapy on mortality is equally evident: UNAIDS has reported that AIDSrelated deaths have fallen by 48 percent since the peak in 2005, and deaths specifically 

attributed to TB among people living with HIV fell by 33 percent These effects will be 

amplified as we further scale up antiretroviral therapy to all PLHIV. And this success actually 

comes with a cost-saving: modeling data from Botswana show that in addition to preventing 

4 
17


30710a-5.eps

tens of thousands of TB cases, antiretroviral therapy given to all PLHIV will save tens of 

millions of dollars in TB treatment costs over the next 15 years 

In order to accommodate the increase in the number of patients who are being treated with 

antiretroviral therapy as a result of Test and Start, we are decongesting the healthcare facilities 

by spacing out follow-up appointments for the vast majority of PLHIV who are doing well and 

shifting monitoring of adherence and symptoms to community health workers. This will not 

only free up clinic appointments for those that are newly registering, it will also develop 

healthcare infrastructure in the communities where TB and HIV patients live, facilitating 

treatment adherence and diagnostic evaluation of those with symptoms and those who were 

exposed to either disease. 

The third area of focus is the early diagnosis of TB in persons with HIV and increasing access 

of TB preventive therapy. By emphasizing routine screening for the symptoms of TB disease 

in all PLHIV at every visit to a PEPFAR-supported facility, we are able to find TB disease early 

and refer directly for diagnostic workup and treatment, key to preventing drug resistance. Our 

recent data show that 76 percent of our patients were screened for TB at their last visit We 

remain focused on improving the frequency and quality of TB screening and are collecting sitelevel data to focus our interventions. 

We are using sensitive diagnostic technology followed by effective treatment to save more 

lives and lower TB transmission. The GeneXpert platform is a cartridge-based diagnostic tool 

that uses molecular technology to diagnose TB disease. It doesn't require a laboratory setting, 

and can be placed at or near the point of care. It is much more sensitive than traditional 

diagnostic methods, and the newest cartridge is as sensitive as the best laboratory-based 

tests. In 2012, PEP FAR partnered with USAID and the Bill and Melinda Gates Foundation to 

reduce the cost of each test from 17 to 10 dollars, and has directly funded the purchase of 

more than 500 GeneXpert machines in over 20 countries and well over 100,000 cartridges. 

The GeneXpert platform can now be leveraged to document and monitor HIV viral load, which 

is especially important and lifesaving for early infant diagnosis, amplifying the effect of this 

considerable investment PEP FAR continues to play a critical role in providing technical 

assistance to ensure that this platform is efficiently scaled up in a coordinated manner. 

PEPFAR is also making treatment more accessible by pushing to integrate clinical care for TB 

and HIV. In the countries where we work, TB and HIV are often separate programs with 

separate clinic systems that are frequently not co-located. This means that historically, 

patients with HIV and TB disease needed to engage two different and often uncoordinated 

care and treatment systems. As recommended by the World Health Organization, PEPFAR is 

integrating TB/HIV care by providing care for both diseases in one clinic. We are building 

capacity in partner governments through effective policy change and focused training, which 

will allow treatment of HIV in TB clinics, greatly diminishing the burden put on patients and 

promoting adherence and retention in care. 

The risk of TB disease and its attendant mortality can be further reduced by adding TB 

preventive therapy to antiretroviral therapy. This is a key intervention. The combination of TB 
18


30710a-6.eps

preventative therapty and antiretroviral therapy has been shown to reduce the risk of TB 

disease by almost 95 percent, and TB preventative therapy has been shown to reduce 

mortality in PLHIV by 37 percent, independent of antiretroviral therapy and CD4 cell count. 

If immediate antiretroviral therapy is the cornerstone of PEPFAR's TB/HIV efforts, then TB 

infection control and TB preventive therapy are the capstones. We are actively monitoring all 

PEPFAR-supported facilities to ensure that they each have and are compliant with policies for 

preventive therapy and infection controL TB preventive therapy for people living with HIV has 

been a World Health Organization recommendation for years, but with the newer global targets 

and the ambition to end the TB epidemic, it has become a more prominent component of TB 

control efforts. PEPFAR has always recommended TB preventive therapy for our patients, but 

in the past, most countries did not have a specific policy, and we did not closely follow how 

well preventive therapy programs were implemented. That has changed. Almost all of the 

countries in which we work now have national guidelines recommending preventive therapy for 

PLHIV. 

In 2016, PEPFAR revised the suite of TB indicators and now mandates reporting on initiation 

and completion of TB preventive therapy as well as TB screening and initiation of TB therapy 

in those diagnosed with the disease. These additions were part of a deliberate attempt to drive 

programming and encourage fully integrated TB/HIV care in PEP FAR countries. In the past 

year, we have seen a remarkable increase in PEPFAR targets for TB preventive therapy 

despite limited advanced planning and no requirements for targets for FY 2018, 21 countries 

have initiated or expanded TB preventive therapy programming, and the targets for FY 2019 

are substantially higher in almost every country 

A number of markedly successful programs have been introduced: the Democratic Republic of 

Congo, Malawi, Mozambique, and South Africa have all had steady progress incorporating TB 

preventive therapy into routine care with approaches that are well documented and replicable. 

More notably, Kenya had tremendous rapid success rolling out TB preventive therapy through 

a well-designed, carefully crafted collaboration between the country's national TB and HIV 

programs Their approach resulted in an increase in the number of PLHIV who initiated TB 

preventive therapy from a total of 10,000 PLHIV in 2014 to more than 880,000 by this year, 

with treatment completion rates approximating 90 percent for most implementing partners. We 

are promoting TB preventive therapy in all of the countries where PEP FAR is implementing 

programs and will continue to monitor and expand to ensure that all of our patients have been 

treated. 

With correct application of sufficient resources, the fight against TB/HIV is a battle we can win. 

We must make a commitment to finding and treating all persons with HIV before they have 

immune impairment and get clinically sick, and we must find and effectively treat all persons 

with TB disease -we simply cannot afford not to. We need to facilitate effective treatment to 

unburden our patients. Care should be integrated and mainstreamed, and adherence should 

be promoted in ways that do not require patients to report for observation. Inadequate or 
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30710a-7.eps

erratic treatment has led to the development of drug-resistant disease, which now threatens to 

undermine the progress that is being achieved. 

Once it develops, drug-resistant TB spreads exactly the same way as drug-susceptible TB to 

anyone who shares air with a sick patient It is expensive and extremely difficult to treat 

patients with drug-resistant TB on a large scale- but the financial and public health 

consequences of our failure to do so will be devastating. It is an imminent and growing threat 

to public health. Recent reports suggest that by 2050, the consequences of drug-resistant 

microbes, most importantly multi-drug-resistant TB, could have a more catastrophic impact on 

global financial mechanisms than the 2008 housing crisis. 

But such a crisis can be avoided. All the interventions I've mentioned are proven conceptsnone are controversial or questionable, they simply need to be fully scaled. Effective scale-up 

of these interventions will allow us to gain control of the TB epidemic in high H IV settings. The 

goal of PEP FAR is to save lives and, by doing so, revive communities afflicted with a high 

burden of HIV. By greatly expanding antiretroviral and TB preventive therapy, while 

diminishing the burdens placed on patients, we are cutting transmission of both diseases and 

getting ever closer to realizing a world free of HIV and TB. The continued focus on effective 

and innovative TB/HIV programming will help consolidate those achievements and further 

global efforts to end the TB pandemic. 

Chairman Smith, Ranking Member Bass, and other distinguished members of this 

Subcommittee, thank you for the opportunity to appear before you today. We are profoundly 

grateful for the ongoing support and engagement of the House Foreign Affairs Committee and 

this Subcommittee for PEPFAR's work. 

Thank you I look forward to your questions. 
20

Mr. SMITH. Dr. Birx, thank you very much. 

Ms. Koek. 

STATEMENT OF MS. IRENE KOEK, SENIOR DEPUTY ASSISTANT 

ADMINISTRATOR, GLOBAL HEALTH BUREAU, U.S. AGENCY 

FOR INTERNATIONAL DEVELOPMENT 

Ms. KOEK. Thank you very much, Chairman Smith, Ranking 

Member Bass. Thank you very much for your leadership and support for the work the U.S. Government does to advance global 

health and your commitment to fight tuberculosis. 

I am very honored to be here today with my U.S. Government 

colleagues to discuss our collective efforts against this deadly disease. 

TB has long been an important issue for me. As chief of the infectious diseases division I helped start USAID’s program 20 years 

ago and watched it grow the first part of its existence. 

Thanks to the support of Congress, the U.S. Government is the 

single largest donor to TB programs globally. Collectively, we share 

a vision of a world free from TB. 

The collaboration and complementary efforts of USG departments and agencies is reflected in our implementation of U.S. Government global TB strategy and the MDR national action plan. 

USAID leads USG global TB efforts through our support for 

high-quality diagnosis, treatment, prevention, and care services for 

millions of people who are at risk or suffer from MTB and MDR 

TB. 

We focus in 22 high-burden countries including five in southern 

Africa. We also support an additional 32 countries through targeted 

technical assistance primarily in support of Global Fund TB grants. 

Our efforts are designed to accelerate and optimize implementation of country-owned and led national TB programs. In order to 

achieve the greatest impact on the TB epidemic, we focus on the 

areas with the greatest burden of disease and on ensuring that the 

innovations with the highest potential are rapidly identified and 

widely implemented. We focus in countries with the highest burden 

of TB, of drug-resistant TB, and HIV-associated TB. 

We use data to target our interventions to benefit the majority 

of those suffering from TB. TB predominantly affects the poorest 

and most vulnerable with approximately 95 percent of TB deaths 

occurring in low and middle income countries. 

Each day, more than 4,600 individuals die from this curable disease. The majority of the TB burden is in Asia. Almost 60 percent 

of all TB cases are found in India, Indonesia, China, Pakistan, and 

the Philippines. 

Although while HIV-associated TB only accounts for one-tenth of 

the world’s TB cases, it has a disproportionate impact in Africa, 

which is home to 75 percent of the global TB-HIV cases. 

The investments on TB have paid off. Since 2000, our support in 

USAID priority countries contributed to a 40 percent decrease in 

TB-related mortality and a 27 percent decrease in TB prevalence. 

In the last 2 years, USAID has helped provide high-quality TB 

treatment for 6 million TB patients including 150,000 MDR TB patients. USAID investments over the past 20 years have dramatically improved global and national TB surveillance systems, which 

21

have enabled better targeting of interventions at the global and 

country level, and improved data for decision making. 

At the country level, USAID works with national TB programs 

and local partners to scale up and accelerate implementation of 

new tools and approaches, focusing on four pillars. 

The first is person-centered care. TB care has evolved to embrace 

a human rights approach that is focused on meeting the individual 

needs of each person so they are able to access timely quality diagnosis, care, and treatment regardless of where they seek services. 

Typically, this is through primary health care in community settings. USAID increasingly works with faith-based and community 

organizations to provide the support needed, improved treatment 

outcomes, and combat the stigma so often borne by TB patients, 

particularly among women and children. 

Secondly, access to early diagnosis and initiation of quality treatment is one of the best ways to prevent the transmission of active 

TB disease as well as the development of MDR TB. 

We leverage American innovation in industry to scale up new 

tools for better diagnosis and treatment. With Johnson & Johnson, 

for example, we’ve introduced bedaquiline, a new TB option for people with drug resistance in more than 70 countries for 25,000 people often providing the only treatment option. 

USAID is also partnering with diagnostic companies such as 

Cepheid and Becton Dickinson to expand access to rapid TB and 

drug-resistant testing. 

The third pillar is preventing the development of active TB disease. USAID works to prevent both the transmission of TB from 

one person to another and the progression from latent TB infection 

to active TB disease. 

The combination of TB preventive therapy and anti-retroviral 

therapy reduced the risk of developing active TB disease and people living with HIV by up to 90 percent. 

As Ambassador Birx has already noted, scaling up TB-preventive 

therapy among people with HIV is critical and requires a strengthened and more focused approach. 

Fourth is accelerating research and innovation. USAID’s research portfolio has been a key component of our TB program since 

its inception. In close cooperation with USG partners, USAID has 

supported several late-stage research cities that have led to major 

policy changes, including a standardized fixed dose combination TB 

regimen and a shortened MDR TB treatment regimen. 

The U.N. High Level Meeting on TB later this year will provide 

a much-needed opportunity to bring global attention to a disease 

that, despite its horrific impact is all too often ignored or unseen. 

It is critical that we continue to maximize investments and leverage additional resources to bring self-reliant sustainable TB responses within countries. 

We stand at a pivotal juncture, but with your steadfast support, 

we can help the world take the right path. With increased political 

commitment, we can and will end TB. 

Thank you again for your support. I look forward to your questions. 

[The prepared statement of Ms. Koek follows:]

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30710b-1.eps

Irene Koek 

Senior Deputy Assistant Administrator 

Bureau for Global Health, United States Agency for International Development 

House Committee on Foreign Affairs 

Subcommittee on Africa, Global Health, Global Human Rights, and International 

Organizations 

July 12, 2018 

Introduction 

Chairman Smith, Ranking Member Bass and members of the Subcommittee, thank you for 

inviting me to testify on the US Agency for International Development (USAID) response to 

the tuberculosis (TB) epidemic in southern Africa and globally. 

As South Africa Minister of Health Aaron Motsoaledi has so aptly said of death by 

tuberculosis "[it] happens very slowly, maybe in a corner somewhere, in an isolated hospital 

ward, with nobody watching, so it doesn't evoke any emotion. Maybe that's what's at play 

around the entire world." 

For more than 20 years, the US Government (USG) has been a leader in the global effort to 

increase access to TB diagnosis, treatment, prevention and care, particularly in countries with 

the highest burden of disease. Thanks to the generosity of the American people and the strong 

support of the US Congress, USAID is the largest bilateral donor in the fight against TB. We 

work in partnership with national TB programs (NIPs) in Ministries of Health (MoHs), the 

Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund), the World Health 

Organization (WHO), the Stop TB Partnership, technical assistance organizations, civil society 

including faith-based organizations, as well as affected people and communities. USAID has 

driven and funded interventions, tools, and technologies that have helped save 53 million lives 

from 2000 to 2016. Our efforts to build partnerships with national governments, multilateral 

organizations, and departments and agencies across the US Government have developed and 

strengthened country capacity to end the TB epidemic around the world. 

TB has long been an issue of particular concern for me. Twenty years ago, I was privileged to 

play a key role in the creation of USA !D's TB program. During my tenure as head of the 

USAID's Infectious Disease Division, the USAID TB program grew to be a major component 

of USA !D's health portfolio. 1 was also heavily engaged in the creation of the Global Drug 

Facility (GDF) and the Stop TB Partnership, a unique international organization comprised of 

1,500 partners dedicated to work collectively to end TB. 

U.S. Government collaborative efforts to end TB globally 

The U.S. Government's global TB strategy leverages interagency strengths and innovations to 

endeavor to reach every person with TB, cure those in need of treatment, and prevent the spread 

of the disease and new infections. 

The vital collaboration and complementary efforts across the USG are reflected in our shared 

successes through the implementation of the U.S. Government Global TB Strategy (20 15-20 19) 

and the National Action Plan for Combating Multidrug-Resistant TB (2016-2020) as we work 

together to save lives and protect America's global health security. The U.S. Government 
23


30710b-2.eps

Global TB Strategy outlines clear roles and responsibilities for each federal partner. Among 

them, USAID leads international TB etTorts to increase access to high quality, person-centered 

diagnosis, treatment, and care for TB and multidrug-resistant (MDR) TB. The Office of the 

Global AIDS Coordinator leads international HIV/AIDS etl'orts, including TB/HIV. The 

Centers for Disease Control and Prevention (CDC), within the Department of Health and 

Human Services (HHS), works domestically and globally on TB, including through PEPF AR, 

on research, surveillance, diagnostic and laboratory capacity, and treatment. The National 

Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases 

(NIAlD), also within HHS, conducts biomedical TB research that infonns the overall TB effort; 

and the Department of Defense supports TB diagnosis and operational research through 

international laboratories. With the U.S. Government as the largest contributor to the Global 

Fund, combined with USAID's bilateral etTorts, resources dedicated to TBIHN coinfection 

efforts through the President's Emergency Plan for AIDS Relief(PEPFAR), and NIH and CDC 

investments in research, the U.S. is by far the leader in work to end TB worldwide. 

The National Action Plan promotes greater coordination to reduce the domestic and global risk 

ofMDR-TB; increases the American public's awareness of the threats posed by the disease; and 

serves as a call to action to all stakeholders on this worldwide concern. Similar to the U.S. 

Government Global TB Strategy, the three goals of the National Action Plan are implemented 

through a collaborative effort by multiple US. Government departments and agencies, with 

USAID leading the second goal of improving international capacity and collaboration to combat 

MDR-TB. 

USAID leads U.S. Government global TB efforts through its support for high-quality diagnosis, 

treatment, prevention, and care services for millions of people with TB and at risk for TB and 

MDR-TB. The Agency bilateral TB program works with MoHs in 22 high-burden countries 

including Malawi, Mozambique, South Africa, Zambia, and Zimbabwe in southern Africa to 

produce sustainable results. USAID investments in TB save lives by improving the capacity of 

NTPs to introduce and expand access to new tools and high-quality TB services. In addition to 

USAID's bilateral programming, the Agency supports an additional 32 countries through 

targeted technical assistance and support for Global Fund grants including Angola, Botswana, 

Lesotho, Madagascar, Namibia, and Swaziland in southern Africa. In all, the Agency provides 

focused assistance to 54 countries, including II in southern Africa, to optimize implementation 

of country-owned and led national TB programs. 

Global TB situation 

TB is the leading infectious cause of death, ninth leading cause of all deaths worldwide, and the 

most common cause of death in people with HIV. Each day, more than 4,600 individuals die of 

this curable disease, culminating in 1.7 million deaths each year--for context, that's more than 

twice the size of the population of the Chairman's congressional district in New Jersey. In 

2016, approximately 10.4 million people developed TB, including 3.7 million women and I 

million children. Worldwide, more than two billion people are infected with Mycobacterium 

tuberculosis, the bacterium that causes TB. Those at greatest risk of developing active TB 

disease are those with compromised immune systems, including HIV, diabetes, and 

malnutrition. The disease predominantly affects the poorest and most vulnerable, with about 95 

percent ofTB deaths occurring in low- and middle- income countries. The majority of the 

global TB burden is in Asia. More than 55 percent of all TB cases are found in India, Indonesia, 

China, Pakistan, and the Philippines. If we don't solve TB in these countries, we cannot end TB. 

Every year, about 60 percent of individuals with active TB disease are officially reported as 

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diagnosed and initiated on treatment. The remaining "missing" 40 percent--4.1 million people--

do not receive services that meet international standards, which can lead to significant 

morbidity, drug-resistant (DR) TB, and even death. Unfortunately, the longer people with active 

TB disease remain untreated, whether it is drug-susceptible (DS) or DR, the more likely they are 

to spread the disease, infecting their families and communities. People with active TB disease 

can infect up to 10 to 15 other people over the course of a year. 

Mrica's estimated 2.6 million annual cases ofTB comprise 25 percent of the world's TB 

burden. 1n Mrica, the TB mortality rate in both those who are HlV-negative and people living 

with HlV (PLHIV) is, respectively, more than two and six times higher than the global average. 

The TB epidemic in the African region, as in other regions, is driven by a variety of factors, 

including weak health systems, but is exacerbated by the high prevalence of HIV, particularly in 

southern Mrica. 

TB is the leading killer ofPLHIV, accounting for 40 percent of all HIV deaths worldwide. In 

2016, almost 400,000 of the one million people with HIV-associated TB died ofT B. As one of 

PEPF AR' s main implementers, US AID works to mal<e sure that countries receiving both 

PEPFAR funds and TB funds are coordinated, to ensure that patients have access to quality 

services for TB and HIV regardless of where they receive their care 

USAID's bilateral TB program is working with countries to mal<e certain every TB patient is 

being tested for HIV. In 2016, 82 percent ofTB patients in the Africa region had a documented 

HIV test. PEPFAR data indicate that about half of eligible patients on antiretroviral treatment 

(ART) were screened for TB in 2017. Screening for active TB disease among PLHIV is 

important not only to identify individuals who would benefit from TB treatment for active 

disease, but because it can also identify individuals who would benefit from TB preventive 

therapy (TPT), which can greatly reduce the risk of developing active TB disease. When TPT is 

used as an adjunct to HIV treatment, the risk of active TB disease in PLHIV can be reduced by 

up to 90 percent. Screening for TB among PLHIV and scaling up TPT requires a strengthened 

and more focused response. 

While HIV has the greatest impact on the TB epidemic in Africa, DR-TB is a major public 

health concern globally. DR-TB threatens to reverse progress made in combating the TB 

epidemic throughout the world. Experts have determined that by 2050, 75 million people will 

lose their lives to DR-TB and that the disease could cost the global economy $17 trillion. 

Weal< TB programs contribute to the development and spread of DR-TB which, like DS-TB, is 

transmitted through the air from person to person. MDR-TB, a form ofTB that is resistant to 

two of the most efilcacious medicines used to treat DS-TB, is present in every country in the 

world; extensively drug-resistant (XDR) TB, which is resistant to even more drugs, has been 

reported in more than 100 countries. In 2016, there were an estimated 600,000 cases ofMDRTB worldwide, accounting for more than four percent of all new TB cases; 93,000 (16%) were 

in Africa. 

Despite the continuing and devastating impact of TB around the globe, considerable progress is 

being made. Since 2000, the TB mortality rate decreased by about 37 percent and the incidence 

rate declined by about 19 percent. Recent innovations have dramatically expanded our ability to 

rapidly diagnose all forms of TB and provide appropriate, life-saving treatment and care to 

those in need. 

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USAJD response to the global TB situlltion 

USAID works in most of the countries with the highest burdens ofTB, MDR-TB, and TB/HIV 

to strengthen health systems and increase country capacity to provide high-quality TB services. 

Since 2000, our contributions have helped priority countries achieve an almost 40 percent 

decrease in TB-related mortality and a 20 percent decrease in TB incidence. USAID has helped 

provide high-quality TB treatment for almost 6 million TB patients, including almost 150,000 

MDR-TB patients, in just the last two years. Over the past 20 years, USAID investments have 

also improved international and national TB surveillance systems, which have enabled better 

targeting of interventions at the global and country level, and identified trends in TB and MDRTB which have infonned policies, research, and response. 

USAID has been a catalyst for investment and change in high burden TB countries. Over 80 

percent of funding to support the TB response is financed through national domestic resources. 

With the majority of the world's TB cases in middle income countries, and with the limited 

international TB resources available, USAID has played a critical role in accelerating and 

enhancing the TB response in supported countries by influencing national and subnational 

clinical and technical policies and guidelines to improve the quality of care and introduce new 

approaches and tools, and has helped ensure coordination to maximize efforts. The Agency 

continues to work with governments and major partners to mobilize domestic resources and 

drive quality improvements for sustainable, multi sectoral, person-centered TB programs. 

The Agency's commitment to a person-centered approach requires a multi sectoral response that 

includes ministries and sectors other than those directly related to health care. For example, 

USAID engages Ministries of Labor to reach manufacturers and workers, Ministries of 

Education to reach teachers and children, correctional agencies to reach prisoners and guards, 

faith-based and community organizations to reach families and communities, and the corporate 

sector to reach companies ranging from mining enterprises to the phannaceutical industry and 

private health care providers. At the country level, USAID works with NTPs and local partners 

to scale up and accelerate implementation of the following tools and approaches: 

Person-centered care: To improve quality of care and TB outcomes, USAID works with a 

range of organizations to ensure services are tailored to the needs of individuals and their 

communities. TB care has evolved to embrace a human rights approach that is focused on 

meeting the individual needs of each person so that they are able to access timely, quality 

diagnosis, care, and treatment in a supportive environment that is based on respect for patient 

autonomy, physical comfort, and psychosocial support. Individuals receiving TB treatment face 

months of therapy; those requiring treatment for DR-TB not only face months of therapy but 

toxic and often painful regimens. Person-centered care has been shown to reduce stigma, and 

increase patient satisfaction as well as treatment adherence. USAID has pioneered country- and 

population-specific interventions in all priority countries. 

Pub1ic-privale partnerships: USAID continues to leverage American innovation and leadership 

in an effort to scale up new tools to improve the quality of diagnosis and treatment. In a joint 

effort with Johnson and Johnson, the Agency has introduced bedaquiline, the first new TB drug 

approved by the Food and Drug Administration (FDA) in more than 50 years. More than 

25,000 treatment courses are now available in more than 70 countries to treat people with DRTB. USAID led the successful effort that resulted in rapid global introduction and scale-up of 

this new drug regimen. In addition, USAID has been instrumental in the introduction of the 

shortened MDR-TB treatment regimen (which can reduce the duration of treatment by more 

than 50 percent, from at least 20 months to 9 months) in all priority countries. Some USAID 

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countries with intensified support are enrolling almost 80 percent of those eligible on the 

regimen, improving treatment outcomes and saving precious resources. USAID is also 

partnering with diagnostic companies such as Cepheid and Becton Dickinson to expand access 

to quality rapid testing for TB and DR-IB. fu FY 2016, USAID reduced the number of 

"missing" TB cases by I 0 percent in priority countries by strengthening screening and the 

diagnostic network, to find people earlier so that they can initiate treatment more rapidly, not 

only improving the health of these individuals, but decreasing transmission to others. 

Prerenting the deve1opment ofacth·e TB disease: USAID programs work to prevent both the 

transmission ofTB from one person to another, and the progression from latent TB infection 

(LTBI) to active TB disease in those who become infected. Access to early diagnosis and 

quality treatment is one of the best ways to prevent the transmission of active TB disease, as 

well as the development ofMDR-TB. In addition, TPT, a critical intervention, particularly for 

contacts of individuals with active TB disease and PLHIV, is being expanded in countries. 

F:ngaging the primte health sector: USAID partners with the private sector and affected 

communities to expand their engagement in the delivery of TB services. Across our bilateral TB 

programs, USAID enables providers outside the government system, such as faith-based 

organizations, to care for patients as recommended by national guidelines, and to facilitate their 

inclusion in local planning activities. For example, Ethiopia established a new public-private 

platform within the Federal Ministry of Health to improve the provision of TB care. Through 

USAID technical support, facility standards were finalized and health facility inspectors trained, 

and a learning community for private health businesses was created. In India, US AID trained a 

group of private providers in an urban population of West Bengal to provide quality TB 

services. Although this urban population represented only 15 percent of the total population of 

West Bengal, the project was able to double the TB cases detected by the private sector in the 

state. 

Management of dmgs and commodities: USAID continues to be a major supporter of the GDF. 

The GDF is a pooled procurement mechanism that provides a package of services, including 

technical assistance in TB drug management and monitoring of drug use, as well as 

procurement of high-quality TB drugs at low cost. As the largest supplier ofTB medicines and 

diagnostics, GDF ensures the availability, affordability and quality of TB medicines. Since 

2012, GDF interventions have led to a price reduction in MDR-TB treatment regimens by more 

than 60 percent and several individual drugs by 70 percent. Earlier this year, the GDF 

announced 28 newly signed agreements with manufacturers for 83 products that will result in 

additional savings of approximately $31 million. The price reductions are particularly valuable 

to high-burden, middle-income countries such as South Africa and India, as it is imperative that 

they realize high returns on their domestic investments, ensuring increased and continued selfreliance. 

Monitoring and ~·valuation: USAID provides global technical leadership and country-level 

support to improve the collection, analysis, and use ofTB data to inform policies and programs 

and customize interventions to those most at risk for TB. Timely, accurate, and complete data 

are required for NTPs to make strategic decisions and prioritize services. In addition, the 

Agency provides technical assistance to support the development of global guidance and the 

implementation ofTB prevalence surveys, drug resistance surveys, and quality service 

assessments. For example, the recent prevalence survey in Kenya showed prevalence was three 

times higher in males than females. Not only do males have a higher disease burden, but they 

are also two times more likely to be missed. The survey also revealed that in Kenya, the highest 

prevalence age group among women was 65 and over. This survey provided essential data that 

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is being used to infonn evidence-based, tailored TB programming 

Research and lnnoPalion: USAID's research portfolio has been a key component of its TB 

program since inception. In close cooperation with USG partners, the Agency supports latestage research studies and ensures the uptake of early-stage research supported by departments 

and agencies. Our research focuses on improving the treatment of DS-TB and MDR-TB, 

preventing progression from infection to disease as well as transmission from person to person, 

and building capacity to conduct operational research that improves the perfonnance of TB 

programs. One of the studies currently supported by USAID is the S.tandardized Ireatment 

REgimen of Anti-tuberculosis drugs for patients with Multi-drug resistant Tuberculosis 

(STREAM) study, the first rigorously conducted global trial to test new drug regimens for the 

treatment of MDR-TB that are that are less than half as long as the current regimen (6-9 vs 20-

24 months), eliminate the need for painful injections, and do not cause debilitating conditions 

such as loss of hearing and psychosis. 

Looking ahead 

USAID is committed to accelerating progress toward ending tuberculosis. The Agency 

continues to mobilize increased commitments and funding from high-burden countries and 

other donors in support of this goal. The United Nations High-Level Meeting on TB (UNHLM) 

later this year will provide a much needed opportunity to support these objectives and bring 

global attention to a disease that, despite its horrific impact, is all too often ignored or unseen. 

It is critical we continue to maximize existing resources and leverage additional resources to 

build self-reliant TB responses. The first UNHLM on TB in September this year will provide 

an historic opportunity to galvanize the political commitment needed to step up the battle 

against TB and put the world and individual countries on the path to ending the epidemic. 

With increased political commitment, we will have the opportunity to accelerate action on TB, 

prioritizing domestic resource mobilization, increased early diagnosis and treatment ofTB and 

DR-TB, person-centered care, rapid development and introduction of new tools through 

collaborative research efforts, and furthering of private sector partnerships. 

USATD will continue its work with other USG departments and agencies to maximize our 

investments by leveraging the collective resources of partner governments as well as other key 

stakeholders. In particular, the Agency will continue to expand person-centered approaches to 

TB services; active detection by reaching out to contacts of TB patients; scaling up TB services 

in coordination with HIV programs; expanding engagement with the private sector including 

private practitioners and faith-based organizations; and forging partnerships with the corporate 

sector. In addition, the Agency will continue to advance novel approaches and evidence-based 

interventions to inform global policy t,>uidelines and improve programs. 

USAID remains committed to ending TB. Administrator Mark Green has declared TB, "a fight 

we can win" and has actively engaged to bring greater attention and resources to the issue. The 

Agency has been successfully implementing the USG's Global TB Strategy and looks forward 

to continuing to build upon these achievements. 

Thank you again to Chairman Smith, Ranking Member Bass, and the members of the 

Subcommittee for calling this timely hearing. We stand at a critical juncture in the road between 

the path of ending the epidemic and letting the disease continue to kill more people than any 

other infectious disease each year. With your support, we can help the world take the right path, 

and end TB. 

6 
28

Mr. SMITH. Thank you, Ms. Koek. Thank you very much. 

Thank you all for your testimonies and, again, most importantly, 

for your extraordinary leadership. 

Let me just ask you, now, one of those reasons why drug resistance in all diseases including TB has increased across many diseases—infectious diseases—is the misuse of antibiotics, not completing the regimen as prescribed. 

How are the physicians and the dispensers, the health care professionals—has the education of those individuals and especially 

those who are affected then been as robust as it could be to mitigate that problem? 

Ms. MARTIN. Thank you for the question. I will start off and 

happy to hand over. But, definitely, with the work that we have 

been doing in training health care providers, also working through 

the clinical trials consortium, which engages other countries as 

well, the opportunity to create centers of excellence for training is 

very critical. 

CDC’s efforts as well in combatting anti-microbial resistance has 

taken on these efforts and been ensuring that we are working toward the efforts of addressing, as you have mentioned, both the 

leadership and the use of anti-microbial resistant agents but also 

the importance of making sure that people complete treatment. 

And this is something within TB that we have been working on 

to ensure looking at how to improve regimens for treatment so that 

they can be shorter courses and also less harmful side effects so 

that people will finish and less drug resistance will form. 

Mr. SMITH. Yes. 

Ms. KOEK. If I could just add to what Dr. Martin just talked 

about. 

One of the areas that’s been a real focus for our programs is 

reaching all clinicians and throughout the system. I mean, very 

often what we see at a number of countries is people will go to 

their regular doctor—their private provider, for example—who may 

or may not be trained on tuberculosis or recognize it right away. 

So they may just prescribe some antibiotics or a piece of it. 

So it’s been really important and a real focus to try to reach all 

providers, whether they be in the public sector or the private sector 

and try to make sure that particularly private sector providers—

and we see this often in a number of countries—may not at the 

outset provide the right treatment but to make sure they really understand what the appropriate treatment regimen is and do the diagnosis before they begin treatment. 

And that’s been a really important area of support for us and 

something we really need to continue to get the word out and make 

sure all providers are part of the network and are connected to the 

public system so you can get the reporting up through the—

through the systems. 

Mr. SMITH. You know, the High Level Meeting that’s slated for 

September 26th at the United Nations—which could be a true pivot 

point for all governments, including our own, to have a more cohesive plan—could you perhaps fill us in on where we are in terms 

of—obviously, they will show up—the delegates—on September 

26th with a plan largely intact. 

29

How well along are you in those preparations? What does it look 

like? I don’t think this is the Manhattan Project where we’ve got 

secrets that can’t be conveyed. Could you give us a good insight as 

to where we are right now? 

Ms. KOEK. Let me start and ask my colleagues to add on. 

So there’s been much, much discussion around what really do we 

need to get out of the High Level Meeting and this—actually, this 

meeting is the culmination of years and years of effort to really get 

it on the agenda, and we really owe a big thanks to Minister 

Motsoaledi, who’s been a tremendous champion, to make this happen. 

So what we are really hoping is will come out of this is a very 

high level goal of getting—targeting 40 million people on treatment 

by 2022. So 40 by 2022 is the very high level ask. 

But part of that, and this is one of the things that is being 

pushed through the development of the communique is about making sure there’s an accountability framework. 

So in order to reach that goal, what every country really needs 

to do and using the kind of data that we’ve been talking about, 

that there is an accountability for every country about what they 

need to do to reach those patients who are not yet diagnosed and 

put on treatment and supported throughout treatment. 

We are also really pushing for an independent body to monitor 

that, much like has been done for polio and done so successfully to 

really make sure that there is—that not only is there accountability but there’s a oversight about accountability. 

And then also working with faith-based and civil society groups, 

making sure they’re part and parcel of the commitment and the instruction and also private sector as well. 

Mr. SMITH. Has the outreach to faith-based groups been as robust as it should be? 

Ms. KOEK. I think it’s underway, and this is where the Stop TB 

partnership has been playing a really important role of reaching 

civil society and trying to reach the outreach. 

I think that we can do a lot more and that would be a really high 

priority over the coming months to make sure the faith-based community is absolutely——

Mr. SMITH. I raise that—you know, in my early career in the 

1980s—early in the ’80s—I authored the Child Survival Amendment, which put $50 million into immunizations, and went to Central America several times including to El Salvador when they had 

Days of Tranquility and the FMLN and the Duarte government 

ceased all fighting so kids could be immunized against polio, diphtheria, pertussis, and the like. 

And it was the church that made that happen. They admonished 

mothers, families, to bring their children for the immunization. 

Many of the vaccination sites were church sites. 

I know USAID and Mark Green get it. I know all of you get it, 

how important it is to have a partner that has such a low cost overhead that can get volunteers. 

We’ve done it with HIV/AIDS for years with PEPFAR. But I just 

hope in this mobilization there’s a full inclusion of faith-based entities. 

30

Ms. KOEK. No, I couldn’t agree with you more, sir. The faithbased community is a tremendously important voice on this, and 

as you have described, they’ve been so involved. Members of that 

community have been so involved in health issues but certainly TB 

as well, and I think can be an extraordinarily powerful force at the 

U.N. High Level Mission and it’s part of our engagement. 

And, as you noted, Administrator Green is very, very committed 

to this and we have regular conversations with that community 

and continue to make sure that TB is on their agenda as well. 

Mr. SMITH. Let me ask you—first of all, I want to thank Dr. Birx 

for holding that meeting that we had in New York with Dr. Aaron 

Motsoaledi. We had hoped that he would be here and he had to 

cancel due to other pressing issues. 

But that meeting was extraordinary, so I want to thank Dr. Birx 

for putting that meeting together. 

Let me ask you—for many of our pharmaceutical companies, developing drugs to combat or to, hopefully, cure TB, is a high bar 

because the rate of return is just not there for them and I am wondering if there are incentives—any recommendation you can make 

to try to get even further buy-in on the R&D side with our pharmaceuticals who do amazing work. 

Like on neglected tropical diseases, I mean, they have been leaders and have provided enormous amount of research with very little or no return because it’s the right thing to do, and I am wondering on the TB issue if you could speak to that. 

Dr. BIRX. I will just open on this one because I think one of the—

the important part we have from the program side is as new 

drugs—and we saw the new CDC recommendation in the MMWR 

for a 1-month short course on treatment—our job is that as we 

have these new drugs new regimens available is to get them into 

program, because nothing is more encouraging to the pharmaceutical industry to take their hard-earned research and clinical 

trials and translate that into client care and I think that’s part of—

that’s part of our job to really ensure not only that there’s incentives but that the drugs get utilized quickly when they’re shown to 

be effective. 

This new preventive therapy going to 1 month will be—it’s a 

huge breakthrough for clients. That’s a game changer when they 

know they only have to take a medicine for 30 days. 

We do have supposed to remind people curative drugs available 

today for each of these different entities, we would love that in HIV 

if we had a curative drug. 

So I think for us not to do everything to utilize them effectively 

is really a tragedy. So I think we want to be really committed to 

translating new drugs into action immediately. 

Ms. KOEK. Just to add to that, I think the—you know, we—in the 

last couple of years there finally has been a new drug that has 

come out for TB—bedaquiline and some other—for the first time in 

over 40 years. 

And so the investments in research that have happened over the 

last 10 or 15 years are finally paying off after long, long neglect. 

There are a few more, I think, in the research pipeline and we’ve 

been really fortunate for bedaquiline. Johnson & Johnson, which 

31

has been behind this, is really committed to making sure that it’s 

available. 

We have a memorandum of understanding with J&J to do donation of bedaquiline as it goes through the final stages of research. 

It’s already been approved actually by WHO even ahead of being 

approved by the FDA, which is quite a groundbreaking effort, if 

you will. 

So as we go through the donation program and they move to 

market in the final stages, it will be available and it really has 

made a huge difference on the treatment of MDR TB. 

But there are more drugs needed in the pipeline and we need to 

continue the research pipeline. I know that NIH and it looks like 

the TB Alliance for Drug Development are after it and it’s a hugely 

important part of what we do in TB overall. 

Mr. SMITH. Yes, Dr. Martin. 

Ms. MARTIN. If I could just add to this. I think as well the work 

that is being done, especially in finding the missing cases so the 

active case finding, also makes and closes the gap by 40 percent 

of those who don’t complete treatment, and this will also make the 

market more viable once you see the ability to be able to use the 

drugs and to close the gap for ensuring people are treated. 

Mr. SMITH. Ranking Member Bass. 

Ms. BASS. I want to thank the three of you again for testifying 

today but way more important than that, for your dedication and 

your work. 

Unfortunately, I am doing double duty in two hearings and will 

have to run out. But I did want to ask just a few quick questions. 

You know, you mentioned, Dr. Birx, about diagnosing and treating people right away and I was just curious how is TB diagnosed 

in Africa? I mean, I certainly know how—I worked in the medical 

field for many years. 

We do a skin test or an x-ray. But that also takes time to get 

the results back. So you can’t just see a patient and then give 

treatment. So how is it diagnosed? 

Dr. BIRX. So we are very fortunate in collaborating both with the 

TB program and the HIV program to rapidly get gene experts in 

the field so that we can rapidly diagnosis. 

Now, this gene expert machine is molecular in basis and can be 

used for HPV. It can be used for new zoonotic events. So it is a 

technology that’s now available throughout sub-Saharan Africa. 

We spent the last year mapping where every single gene expert 

machine is, and interestingly, we found that we have more gene expert machines than we need. 

So the good news is that the equipment is not the limiting factor. 

It’s utilizing it effectively. So if we want to test every TB client we 

have enough gene expert machines available in the country and I 

think that’s really reassuring to everybody. 

Until we map them, you know, everybody wasn’t communicating 

but we’ve had this great collaboration between the TB program and 

the HIV program because we were each buying them, and now 

when we put them together we see that there’s a capacity there to 

test everyone and provide that rapid diagnosis and get people on 

treatment immediately. And as you said, that is the key——

Ms. BASS. Right. 

32

Dr. BIRX [continuing]. To the health and welfare of our clients in 

the long run and also the key to creating nontransmissability at 

the household level, and to the health care providers, which we 

have to remember—and thank you for bring that up—it’s really not 

only important that we train the health care provider on how to diagnose TB but also how they can protect themselves with infection 

control. 

Ms. BASS. You were also mentioning a percentage of patients 

that are diagnosed with TB and you test them immediately for 

HIV. What’s the percent? 

Dr. BIRX. Ninety-five. We are up to 95 percent of the TB cases 

are tested for HIV. 

Ms. BASS. No. What’s the percent of HIV—that are HIV positive? 

Dr. BIRX. It changes by country. In South Africa, some places 

it’s—so that graphic where I showed you where we are missing 

men, it’s higher the more people you’re missing early in the early 

stages. 

So as we find ways to find men and well children early, the TB 

cases should plummet. So a TB case and that percentage—having 

a high percentage of HIV and the TB is a reference point for us 

not doing as well as we should——

Ms. BASS. I see. 

Dr. BIRX [continuing]. Because that shouldn’t happen. So we 

want that to be zero. But right now, it’s everywhere from 5 percent 

to probably 60 percent. 

Ms. BASS. Wow. 

Dr. BIRX. But that’s our failure on the HIV side to not getting 

people on HIV treatment early so that there’s no dual infection. 

Ms. BASS. And you mentioned—thank you. Thank you. 

And, Dr. Martin, you were mentioning other countries. You said 

that there are several countries where people come into the United 

States and TB is spread. 

I am used to seeing in Los Angeles a lot of our TB cases were 

in the homeless population. It didn’t impact—it wasn’t from people 

coming in the country but what are those countries that you were 

referring to? 

Ms. MARTIN. Thank you, and just to note too, while they may not 

be U.S. born, it’s not that it’s they’re first arriving with TB. It’s 

more that we are seeing that after a year or 50 percent after 10 

years may move on to active TB disease. 

Ms. BASS. I see. 

Ms. MARTIN. And those countries that we are seeing them are 

India, Vietnam, China, Philippines—I am missing one—Mexico. 

Ms. BASS. Oh, the countries that Dr. Koek was mentioning. I see. 

Ms. MARTIN. And we are seeing, as Irene Koek mentioned, it’s 

with the middle income countries where they’re seeing these as 

well. It’s not just low income countries but middle income countries 

that need to be able to stop and detect diseases where they are occurring—the TB—and stop it before it comes and be able to spread 

or create drug resistance. 

Thank you. 

Ms. BASS. I see. Dr. Koek, did you want to respond to that as 

well? 

33

Ms. KOEK. Yes, just to add on to that, because I think the burden 

is indeed in a number of those countries and in addition to a very 

high burden in southern Africa, particularly where the co-infection 

issue is, as Dr. Birx talked about, but there is a big burden in other 

countries in Africa, which is less driven by HIV, and then as we 

talked about earlier, also in Asia where you do have the largest 

number—countries with the largest numbers and they are these 

lower middle income countries. 

And so our work in those countries is really catalytic because the 

resources to pay for the TB programs or pay for the health systems 

is really coming from the countries but our work is catalytic to 

make sure that—to get the right treatment, make sure the right 

treatment and diagnosis is happening. 

Mr. SMITH. Mr. Garrett. 

Mr. GARRETT. So, obviously, a little late getting to the table here. 

But on the subject matter of tuberculosis, I pulled up the 

Chemonics site. I want to thank you all and your staff. 

I believe that Dr. Birx, you were present on the Chemonics hearing and we got a wonderfully detailed series of responses from you 

all, which I would like to pretend happens all the time that we ask 

for them, but it doesn’t, and I am grateful for that. 

And as soon as I got it, I sat down and looked up Chemonics to 

see if they were doing TB work in sub-Saharan Africa, which 

they’re not. So that abates a potential line of questioning. 

But, you know, I guess what I am most interested in is the costbenefit analysis as it relates to fostering desirable outcomes for 

global stability, minimum basis global human opportunity as within the scope of this committee and how addressing something that 

was largely eradicated, largely, in the United States three generations ago—my father’s mother had tuberculosis that she contracted 

as a nurse during the Great Depression—what the cost benefit 

analysis is for us getting involved in this realm now. 

What’s the good that we are—and this is in no way, shape, or 

form a skeptical question but just an opportunity to tell the story 

that we are able to do and at what cost and are we having success—and, again, I apologize for my tardiness—bang-for-the-buck 

wise. 

Again, PEPFAR is a success story as it relates to HIV in Africa, 

et cetera. We talked about that in a previous hearing. 

What are we doing in this realm that we need to know about, 

that we need to trumpet? When I go tell my constituents of why 

foreign aid dollars matter, why U.S. global health involvement 

matters? 

Dr. BIRX. I just want to thank you for your line of questioning 

during the Chemonics group to really talking about efficiencies and 

effectiveness in programming because that is a very critical component to our work at all times. 

And I think the work that we described within the tuberculosis 

field is—we’ve done analysis not only cost savings for the United 

States but cost savings to the health programs in every one of 

these countries so they can invest dollars in their new and burgeoning issues that are going to come up. 

We know that there’s this youth bulge, and so if we have co-infection of TB or HIV—we had a slide up before you came in about 

34

the undiagnosed HIV cases are all in healthy people now and those 

healthy people are all under 35, and 60 percent of sub-Saharan Africa will be under 20 by 2020. 

So we see that confluence of those two pieces that by preventing 

the next cycle of either HIV or TB the cost savings not only to us 

but to the health system in general for sub-Saharan Africa so that 

they can invest more and more dollars into their new and burgeoning, we hope, growing age expectancy into the 60s in the 

NCDs. 

Ms. MARTIN. Could I add to that question. 

Thank you very much, Congressman. I wanted to just add for our analysis we’ve done. For every $1 invested there’s $43 return on 

the investment for investing in reduction of mortality for TB. 

In addition, we do see multi drug-resistant in TB as one of the 

largest global health security threats in national security to countries both economically and in terms of trade. So I just wanted to 

mention that. Thank you. 

Mr. GARRETT. Yes, ma’am. 

Ms. KOEK. If I could just add one——

Mr. GARRETT. I knew you were ready. 

Ms. KOEK. I hate to beat this horse to death, but just one more 

piece. The other thing about TB is a part of the global efforts and 

the global assistance that the U.S. does provide is more—our resources are relatively small to what countries are putting into their 

own TB programs. 

So our pieces of money, they are really catalytic and it really is 

that 80 percent of the costs are borne by countries——

Mr. GARRETT. And you’re—you’re literally getting buy-in and, 

again, I am a fiscal hawk who leans toward shrinking government 

but I am a big advocate for foreign aid where it’s done properly. 

And so what I want to see, and I think we are seeing here—and 

PEPFAR, again, is the great example—is the good will that we can 

export by virtue of, for lack of a better expression, giving a darn 

that manifests itself, and there are a lot of things that need to happen. That 60 percent of sub-Saharan Africa under the age of 20 by 

2020 is scary in and of itself. 

Having said that, with increased education, for example, you see 

decreased birth rates. Right now, the United States can’t, with $21 

trillion in debt, shoulder this entire burden. 

But somebody’s got to lead. The Chinese foreign aid model is give 

money to the oligarchs and the dictators and ours is to help people. 

But we need to brand it so it’s clear I am asking—there’s a question mark coming—that these are the efforts of the United States—

that this leadership, this seed money, this 20 percent that begets 

the 80 percent, is—essentially got a red, white, and blue USAID—

not literally—label on it. 

Ms. KOEK. Yes, it is, and there’s a lot of recognition for the work 

we do at country level through the TB programs, in addition, that’s 

complementary to the work through PEPFAR because it really is 

recognized that this is coming from the American people and the 

engagement from the U.S. Government. 

Mr. GARRETT. I would commend that to continue and that you 

guys are not the enemy. We are on the same team here. 

Ms. KOEK. Yes. 

35

Mr. GARRETT. That’s so important. I think you stem 

radicalization and there’s certainly a lot of messaging, some of it 

within this country. Have you gone all this time without talking 

about Russian meddling? 

I am trying to identify us as something that I hope we are not. 

We need to be clear on what we are and this is a good way to do 

it. And, again, when I get with my fiscal sort of budget hawk 

crowd, I need to be able to say here’s why this matters—that we 

are quantifying lives saved not just in sub-Saharan Africa but 

around the world by virtue of creating outcomes wherein there’s 

hope, right, I would argue, and Chris has probably heard me do 

this 100 times, that a young person who wants to go to med school 

usually doesn’t strap on a bomb vest. 

But when there’s no hope, the 14-year-old will pick up the AK47 for a meal. So thank you, and please continue to make sure that 

folks know not that we are, you know, hegemonic and all-knowing, 

because arrogance precedes resentment, right, but that we give a 

darn. 

So thank you. 

Ms. MARTIN. If I could add on that, too. I think the other value 

is the lessons that we’ve learned here in the U.S., being one of the 

lowest cases—countries in the world—the lessons we’ve learned in 

how to deal with latent TB infection and how we’ve been able to 

test and how to be able to identify. 

These are practices and opportunities we can share with other 

countries as well our experiences that can then be tailored, and 

this is something as well that gives us an opportunity to share this 

information. Thank you. 

Mr. GARRETT. Thanks for what you do. 

Thank you, Mr. Chairman. 

Mr. SMITH. Thank you. 

Dr. Martin, you had said in an article that you published on 

World Tuberculosis Day that every dollar spent on TB results in 

a $43 economic benefit to society. And, of course, if you’re diseaseor parasite-free—that’s incalculable and we all want to be healthy. 

But in the actual dollars and cents world, we often have to make 

an argument as to why spending that next dollar or dollars is justifiable and that kind of analysis is helpful in prying loose those 

additional dollars. 

So if you could speak to that calculation, if you would. Secondly, 

let me ask, if I could, you know, more than half of the funds—

roughly, $16 billion—for the global plan to eliminate TB by 2035 

are anticipated to be raised by affected countries, and I am wondering if you could speak to—you know, are we talking about greater burden sharing and those countries picking up more of a piece? 

If they don’t, obviously, there has to be a safety net so that sick 

people don’t continue to be sick. So if you could speak to that. 

What countries are doing the best? I mean, we know some of the 

countries are doing the worst. We look at North Korea where the 

President just visited just recently. 

I remember being in South Korea many years ago meeting with 

a priest who actually had access to Pyongyang to treat and help tuberculosis patients including those who were suffering from drug 

resistance. Our Government was supportive—not to overtly beVerDate 0ct 09 2002 08:41 Sep 25, 2018 Jkt 000000 PO 00000 Frm 00039 Fmt 6633 Sfmt 6633 Z:\WORK\_AGH\071218\30710 SHIRL
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cause—but it was like an open secret that they’re there just to help 

the people, and I am wondering, a country like North Korea where 

the health care grid is invisible. 

It doesn’t get much worse, and the prioritization given by Kim 

is probably nonexistent. But, you know, as this drug resistance 

breaks out, obviously there are pockets. Speak to the worst countries of the world, if you would, as well as this idea of the burden 

sharing to meet the goals by 2035. 

Let me also ask you, if I could, what would you like to see included in new TB legislation? Where are the gaps, what haven’t we 

met before? 

You do so much and do it so extraordinarily well by administrative action when there are gaps. But there probably are some authorities and statutory changes that you would find to be helpful. 

What needs to be updated in the national action for combatting 

MDR TB of 2015? Again, that would be a similar issue of what we 

can do—and what you’re doing that we need to catch up on—if you 

would. 

And, again, I did ask before—maybe you can elaborate a little 

further, if you would, for the upcoming U.N. meeting, what does it 

look like? What will the plan, in your view—if you can share that 

with us—look like or is it still in a stage where it’s not ready for 

publication? 

Ms. MARTIN. Maybe you answer this. 

Okay. I will start with the first question. On that, as we’ve said, in terms of doing the analysis of looking, that for every $1 that’s 

invested in reducing mortality due to TB we do find a $43 savings. 

Now, this—in looking at return on investments for other infectious diseases, this is very comparable, but actually one of the 

higher ones in terms of being able to invest. 

And I think as Irene Koek has mentioned, we do see that countries are shouldering most of the burden and the cost of this—of 

80 percent of the cost for TB are paid for by the countries that have 

the disease burden as well and that this will continue. 

To your point then about what’s going to be needed and looking 

at to shoulder this, going forward, and what are we expecting countries to do, I think one of the biggest things that’s important, and 

it leads into the U.N. General Assembly, is the political will—creating that political will and having that—those champions to be 

able to make sure that this is taken on as a serious issue and 

brought forward. 

We’ve seen this in some countries and you asked for some good 

examples. Looking at India—one country where we work—we’ve 

been working at looking at how to improve air control and air quality in some of the facilities. 

The model that was seen did lead to good success for infection 

prevention and control and the states has now been expanded to 

an additional seven states in India. But the government is picking 

this up and doing it themselves. 

So as we see good practices and the governments being able to 

take them on and to scale them up, our funds are seen—our activities are catalytic in moving forward a lot of these efforts. 

In thinking about what are some of the—what post-UNGA looks 

like and thinking about this, I think Irene Koek has mentioned 

37

very well the need for an accountability framework, and this is to 

look at progress being made globally but also the resources that are 

being tracked and being followed. 

The mention of an independent monitoring board such as exists 

for polio eradication is one example of moving this effort forward. 

But it would have to make sure that there is some accountability 

and I think U.S. leadership in this is critical and appreciate you 

keeping this on the agenda to move these efforts forward, and 

thank you for your work in that. 

The other big piece, I think, as we’ve mentioned, is engaging the 

civil society, the faith-based organizations, and really looking at 

well, how U.S. commitment can be leveraged by other countries to 

get them more engaged as well as to step up and ensure that we 

continue our resources globally for the efforts that are needed. 

I will stop there for now. Thank you. 

Ms. KOEK. Just building on some of your questions, on the $16 

billion I don’t have the global plan in front of me and we’d be 

happy to share that. But exactly as Dr. Martin said, 80 percent of 

it does come from countries. 

Now, a significant share from the administrative health budget, 

if you will, but there’s also a concern that a fair bit of that also 

comes from out-of-pocket expenditures, and since TB really does affect the poorest of the poor, we want to make sure that they’re not 

being driven into complete poverty by TB. 

So looking at those details at a country level is really, really important. But I would be happy to share what we have on that, as 

we go forward. 

Mr. GARRETT. Yes, if you don’t mind. You have really given me 

a great segue. So we know that TB affects the poorest of the poor 

and we know that we try to tie our aid to the economic achievement in a country because it’s more reasonable to demand that, 

say, South Africa chip in than maybe one of their neighbors to the 

north who might not have the opportunity toward economic prosperity that, say, the mining has perpetually sort of brought to 

South Africa. 

But all fruit aren’t apples and so in South Africa, for example, 

in the Rand buildup around Pretoria you have got sort of a transient population based on economic opportunity that exists within 

the mining employment community and therefore a heightened risk 

of transmission and then travelling outward. 

How do you make sure we are not doing a one-size-fits-all and 

saying well, South Africa has achieved this level of economic 

achievement, therefore, they need to carry this burden, when perhaps we might be more effective in addressing the spread if we target sort of the hotbeds of transmission, right, which exists there. 

And then, secondarily and tangentially, I’ve been—the health 

minister in South Africa has kind of taken a role here. If you can 

sort of tie that in in your response. I was going to say Aaron’s last 

name but then I would say it wrong and——[laughter]—we learned 

it by reading. 

Ms. KOEK. Thank you, because that actually leads into an answer to one of Chairman Smith’s other questions because——

Mr. GARRETT. Teamwork. 

38

Ms. KOEK [continuing]. South Africa is a really good example 

both of a success story and given the strong leadership we’ve seen 

from Mr. Motsoaledi in the government and even courteous I’ve 

had practice, sir, on it—[laughter]—and they’ve worked—the government and the minister of health has worked really closely with 

the mining industry to make sure that because it is—mines are a 

hotbed of TB, right, and miners do go back to their homes where—

which might be much poorer—so making sure they’re—the miners 

are tested and started on treatment and the treatment is followed 

as they go home so they’re not taking TB back to their communities. So we have a very, very strong program on that partnership 

with the mining industry. 

Our work in South Africa is, you know, minuscule compared to—

in terms of dollar amount. You know, it builds on the work that 

Ambassador Birx is doing through PEPFAR around TB—that it 

really is that kind of partnership Ambassador Birx talks about before—that it is meant to catalyze what the Government of South 

Africa is doing. 

And exactly as you say, that work in South Africa is much more 

catalytic and much smaller relative to what we might need to do 

in a much more poorer country. We are trying to work also with 

the global fund grants in those countries to make sure they’re——

Mr. GARRETT. And one of the problems of government inherently, 

in my experience—and I think you guys do a bang-up job here—

but is that we do create a one-size-fits-all paradigm wherein sometimes we let things fall out. 

So that’s to be commended you have identified really the problem 

and—because, yeah, I mean, on an economic achievement scale and 

by virtue of natural resources that are really, in certain areas, unparalleled, but and—so yes. 

Ms. KOEK. Just on that——

Mr. GARRETT. Avoiding the ‘‘this is the way we do it so this is 

the way we should do it’’ thing, which I think you’re doing. 

Ms. KOEK. On that point because it’s really an important one, 

and one-size-fits-all really doesn’t work for something like TB as it 

does for anything else. 

So we work really closely with our counterparts at country for—

they’ll have a strategy for how to deal with TB—where are the—

where is the burden the greatest—where are the patients most—

where do we need to do the most work. So working within that——

Mr. GARRETT. Now if we could just get you guys——

Ms. KOEK [continuing]. Country level strategy is what happens, 

and it really does vary from one country to another. 

Mr. GARRETT. We just need to get you guys to work on K-12 out 

here in the states. 

Dr. BIRX. Just quickly, because I think it ties some of your pieces 

together and you talk about what things should look like. 

I mean, what we’ve learned in PEPFAR is this political will and 

transcending that political and to really focusing domestic and 

global resources where the need is the greatest. And I think you 

point out a really critical issue. 

Oftentimes, in opposition areas, in informal settlements, there is 

not that same attention to the most vulnerable who are at higher 

risk for HIV and TB, and we need to link our catalytic funds to 

39

these kind of policy changes and investments that are linked to 

where the need is the greatest and I think holding countries accountable to investing in this accountability framework needs to be 

linking where diseases are and where investments are because we 

often see that those aren’t always in complete alignment and I 

think that’s really important. 

And I think when you talked about education of the health care 

workers and that importance, the piece of this within the FBOs 

that I think we haven’t paid enough attention to in the last decade 

is the alignment with the churches and engagement with the 

churches. 

We have to get education back into the churches around these 

core diseases. They can be critical and identify the most vulnerable 

in the community that aren’t getting adequate access to either 

health care or the resources that they need and I think the FBOs 

have been tremendous but we need to engage directly the pastors 

in the churches in a real way. 

Mr. SMITH. Before I yield to Mr. Castro, on that point—on one 

trip to Nigeria that I made during the previous administration, we 

had about $500 million health care budget. So I asked how much 

of that in Nigeria, like much of Africa if not all of sub-Saharan Africa is being allocated toward faith-based entities. 

I had just left Jos, where churches have been firebombed and 

Archbishop Kaigama had a HIV/AIDS or a PEPFAR program 

pulled from him, which was absolutely inexplicable for orphans—

100 orphans—and all of a sudden there’s no more money. 

I never got an answer, ever. But I asked how much of that money—the $500 million—has been broken out for faith-based 

work in Nigeria, and it was about 7 percent, 8 percent. Just that 

has to change and is changing, like I know. 

I would like to yield to Mr. Castro. 

Mr. CASTRO. Thanks. Thank you for your testimony and thank 

you for being here and for all the work that you’re doing in Africa 

and, I am sure, in different parts of the world. 

I am told by my grandmother—I was told back then that her 

mother died of tuberculosis in Mexico around 1922—early 1920, 

and I notice that there has been about a 26 percent cut in the 

President’s budget request in 2018 from 2017. 

And so let me ask you what would be the impact—the human 

impact of the work that you do and how many more people 

wouldn’t get served if that in fact ends up being the cut that we 

sustain? 

Ms. KOEK. Thank you, sir, and I really do want to appreciate and 

thank the strong support we’ve received from Congress for the TB 

program. So I think you’re aware the budget request did reflect an 

overall constrained budget environment. 

However, the resources that were in that even reduced request 

would be targeted to the highest priority countries for us where the 

biggest burden is. 

So I can’t quite do the calculation on how many people would not 

do services, but given that our work really is catalytic, meant to 

be for—at country level, we would really try to prioritize among 

those high burden countries and try to really make sure that the 

resources went as far as they could. 

40

Mr. CASTRO. But you agree that less people will get served? 

Ms. KOEK. I would imagine so. It would have to be a calculation. 

We’d have to. 

Mr. CASTRO. Sure. Yes, I guess I can submit for the record an 

analysis, I mean, if there’s 400,000 people each year in Africa that 

die from tuberculosis. So I will submit a question for the record on 

the human impact of the 26 percent cut if it in fact goes through. 

Let me ask you, the chairman sent out a memo that has the 

rankings of the top 10 causes of death worldwide and but do you 

know with respect to Africa where TB ranks? This is a worldwide 

ranking, but do you know where it ranks in terms of Africa? 

Dr. BIRX. Right now, it’s the primary infectious disease cause of 

death because of the high HIV-driving component to that. So we 

believe, as we control the HIV pandemic, we will control the TB 

pandemic in sub-Saharan Africa in those countries where it’s being 

dual driven. 

Ms. MARTIN. I was just going to add as well, I think the other 

piece that we see is that the increased drug resistance occurring as 

well and also the importance of as we see it being one of the leading causes that as well is if people are not treated and if people 

don’t finish treatment, the opportunity for drug resistance to grow 

and to increase and the impact of that as well increases in terms 

of being able to treat them and the cost to treat them as well. 

Mr. CASTRO. All right. Thank you. 

I yield back. 

Mr. SMITH. Thank you, Mr. Castro. 

Let me just ask one final question. You know, there is an enhanced vulnerability of women who are pregnant to TB and, you 

know, from my point of view, I believe that there are two patients 

when the woman is pregnant—both the unborn child and the mother—and everything humanly possible should be done to enhance 

their health. 

That’s why this committee and I and my staff are so absolutely 

committed to the first 1,000 days from conception to the second 

birthday so the children and the women—the mothers—are as 

healthy as humanly possible. 

And I am wondering, is there any special protocol necessary to 

ensure that the woman’s health is protected and strengthened if 

she were to get TB while she’s pregnant? 

And, of course, what are the vulnerabilities to the baby in terms 

of transfer of the disease? 

Dr. BIRX. I will start. I am glad you picked up on that because 

we’ve also noticed that within HIV. There’s a unique high rate of 

susceptibility—it was just published in an abstract at CROI just a 

few months ago—of women in their last tri semester and in those 

first 6 months after delivery, and we are trying to really understand that. 

And so this increased intensity of oversight and screening both 

for TB and HIV will be absolutely critical because, obviously, it’s 

much more important to the pregnant woman to prevent the disease from ever occurring because the drugs, as all drugs, have toxicity across the board and, certainly, MDR drugs have particularly 

toxicity. 

41

So it’s more about making sure that women remain healthy be 

ensuring they come into the pregnancy healthy and their immune 

system is intact so that you can prevent the occurrence of reactivation of TB. 

Mr. SMITH. Thank you. Okay. 

Anything further any of you would like to say? And, again, your 

recommendations on legislation would be very well appreciated. 

Yes, Dr. Martin. 

Ms. MARTIN. Thank you. 

I just wanted to respond to Congressman Garrett’s question too 

about not one-size-fits-all and how do you identify those areas, and 

I think this is the importance of surveillance and the importance 

of being able to hone in and know what’s happening, having those 

data to be able to use in real time to know where those hot spots 

are—to know what we can then do to focus as opposed to blanketing everywhere how you can really hone in, and that requires 

that we have and that countries have those data available and the 

importance of surveillance to be able to detect and the laboratory 

work to be able to know the confirmation. 

Thank you. 

Mr. SMITH. I just—oh, yes, Ms. Koek. 

Ms. KOEK. I would just say one thing on legislation. I think the 

most important thing from legislation would be it’s the signal it 

sends of the importance of something like TB, and just as this 

hearing has been a really important signal about why this is such 

an issue that requires the attention. 

So we very much appreciate your time on that. 

Mr. SMITH. Thank you. 

Your testimonies and the information as well as the questions 

and those that we’ll submit we do share with the appropriators 

who are always looking for insights, so we will expand this to other 

Members of Congress so that they know just how important this 

is. 

But, again, thank you for your leadership. I would just conclude 

by saying that sustainable political will coupled with compassion 

and competent leadership is the reason, I believe, why the 

HIV/AIDS pandemic, which Henry Hyde, the author of that legislation—it was George Bush and Henry Hyde and all of us behind 

them, but they were the leaders—I remember Henry Hyde telling 

all of us in a Republican caucus that he did it frequently from the 

chair that this is the equivalent of bubonic plague—that unless 

very, very aggressive actions are taken, this will get—it’s already 

awful—it will get far worse. 

And he was a driver like no other, as Bush was right there, of 

course, leading, and it shows that where there’s a political will, 

where that compassion exists and you have competent leadership 

like you, it makes all the difference in the world. 

So thank you. You have friends here on the Hill. It’s bipartisan, 

and we’ll do everything we can to support you, following your lead. 

The hearing is adjourned. 

[Whereupon, at 4:08 p.m., the committee was adjourned.] 

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SUBCOMMITTEE HEARING NOTICE 

COMMITTEE ON FOREIGN AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

WASHINGTON, DC 20515-6!28 

Subcommittee ou Africa, Global Health, Global Human Rights, and International Organizations 

Christopher H. Smith (R-NJ), Chairman 

July 9. 2018 

TO: MEMBERS OF THE COMMITTEE ON FOREIGN AFFAIRS 

You arc respectfully requested to attend an OPEN hearing of the Committee on Foreign Affairs to be 

held by the Subcommittee on Africa. Global Health. Global Human Rights. and International Organizations in 

Room 2255 of the Rayburn House Office Building (and available live on the Committee website at 

http://v .. vnY.ForcignAtfairs.housc.gm--): 

DATE: 

TIME: 

SUBJECT: 

WITNESSES: 

Thursday. July 12. 20 18 

3:00p.m. 

Combating Tuberculosis in Southern Africa 

TI1e Honorable Deborah L. Birx, M.D. 

U.S. Global AIDS Coordinator 

U.S. Special Representative for Global Health Diplomacy 

U.S. Department of State 

Ms. Irene Koek 

Senior Deputy Assistant Administrator 

Global Health Bureau 

U.S. Agency for lntemational Development 

Rebecca Martin, Ph.D. 

Director 

Center for Global Health 

U.S. Centers for Disease Control and Pre\-ention 

By Di.-ection of the Chairman 

c>/ "'''""' •cccmmwJ""""' 1J!eavc' Gul/202 225-5(1]/ ul 

m·allai:!I!Jt\ r.{('amnJJIJce 
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COMMITTEE ON FOREIGN AFFAIRS 

MINUTES OF SUBCOl'vfMITTEE ON. Africa, Global Health~ Global Human Rights, mul JnternationalOrganizatiom HEARING 

Day _ _:cT:c.::7•c.::u:.:rs:.:d:=ay,_· __ Datc~_::_J::::u~V...:l:.:2:z.,.=2::_0=-18:.__Room ___ =.22:::-::.:>5:__ __ 

Starting Time __1,:{/(/[ll!L___.Ending Time ~{j§jJtrl___ 

Recesses .--· {__to __ ) ( __ to __ ) L__to __ )( __ to __ )( __ to __ ) L__to ___) 

Presiding Member(s) 

Chairman Smith 

Check all '!flhefollowing that app(v: 

Open Session G'J 

Executive ~sed) Session 0 

Teleyised U 

TITLE OF HEARING: 

Combating Tuberculosis in Southem Africa 

SUBCOMMITTEE MEMBERS PRESENT: 

Ranking Member Bas.<; Rep. Garrell, Rep. Castro 

Rlectronically Rccord£!!jtaped) D 

Stenographic Record LLJ 

NON-SUBCOMMITTEE MEMBERS PRESKNT: (!vfark with an "if'they are not members olfuli committee.) 

HEARING WJTNESSF,S: Same as mecling notice attached? Yes m NoD 

(lj "no", please list below and include title, agency, department, or organizalion.) 

STATEMENTS FOR THE RECORD: (List any statements submitted for the record) 

Rep. Smith: Statement by Ranking Member of the House Foreign Affairs Committee, Eliot Engel 

Rep Smith: Statement of the American Thomcic Society 

TIME SCHEDULED TO RECONVENE---~ 

or 

TIME AD.JOURNED_~~~-

/J1/) / 

--·~---·~-,--,------

Yv 

SuJ>committee Staff Associate 
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MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS


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an essential global health priority-for the United States and our partners around 

the world. 

Thank you to our witnesses for being here, and I look forward to hearing from you. 
48

MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS


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The American Thoracic Society is a 16,000 member international professional and scientific 

society dedicated to the prevention and treatment of lung diseases, critical illness and sleep 

disorders. The Society was founded in 1905 as the American Sanitorium Association focused on 

the prevention and treatment of tuberculosis and maintains a strong area of interest in domestic 

and global tuberculosis control and related research The ATS thanks Chairman Smith and 

Ranking Member Bass for this important hearing on tuberculosis in Southern Africa. 

TB Globally 

Tuberculosis (TB), an airborne infectious disease, is the leading global infectious killer, ahead of 

HlV/ AIDS, claiming 1.7 million lives each year. 1 In 2016, 10.4 million people became ill with 

TB, 10 percent of whom were children. TB is among the top five causes of death for women of 

reproductive age in low-income countries. While most TB cases are both preventable and curable 

when international guidelines are used, many parts of the world-- such as Africa-- are 

struggling to implement global recommendations, giving rise to drug resistant TB. As the top 

killer of people living with HTV/ AIDS, TB is also undermining the substantial contributions in 

controlling AIDS made by the US government through PEPF AR. 

TB in the US 

Tn the U.S., every state reports cases of TB annually and in 2017, twenty states reported TB 

increases. 2 California, Texas, New York, Hawaii and Alaska are the most highly burdened states. 

TB outbreaks continue to occur across the U.S, outstripping local public health department 

budgets. There are also an estimated 13 million people in the U.S. with latent TB infection.' In 

2013, drug resistant tuberculosis was identified as a serious public health threat to the U.S in 

CDC's 2013 report on antimicrobial resistance 4 Drug-resistant TB poses a particular challenge 

to domestic TB control due to the high costs of treatment, intensive health care resources and 

burden on patients. 

Drug Resistant TB 

Globally there are about 500,000 cases of multi-drug resistant (MDR) annually but only about 

25% of persons with MDR-TB are identified and treated5 MDR-TB is very complex and 

expensive to treat and as a result of these factors, fatality rates from MDR-TB in developing 

countries are high. Extensively drug resistant (XDR) TB, which has been identified in most 

countries, most strikingly in South Africa, is even deadlier. The prevention of new MDR and 

XDR-TB cases as well as finding and successfully treating current cases must be a top priority to 

reduce further deaths and disability. 

TB in the Southern African Development Community (SA DC) 

1 World Health Organization (WHO). Global TB Report 2016.www.who.int. 2 Stewart RJ, Tsang CA, Pratt RH, Price SF, Langer AJ. Tuberculosis- United States, 2017. MMWR Morb Mortal 

Wkly Rep 2018;67:317-323. DOl: http.//dx.doi.org/10.15585/mmwr.mm6711a2 3 National Health and Nutrition Examination Survey, 2011-2012. Htp://www.ncbi.nlm.nih.gov/pmc/arti:les/PMC4b331611 4 Antibiotic Resistance Threats in the United States, 2013. U.S. Dept. of Health and Human Services, Centers for 

Disease Control and Prevention. bJJJ2.~.1lwww.gic.gov/dru_[@sist91]_fJ:i.t!Jreat-repot1:.2013/pdf/ar-thr_eats-2QJ)_: 

508.pdf#page=112 

5 lbid. 
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The countries in the SADC, especially South Africa, have long had very high rates of TB, and 

more recently, have also been hard hit by HlV/AlDS, causing TB rates to increase enonnously. 

Of the 30 high TB burden countries globally, based on either the absolute number of TB cases or 

rates per 100,000 population in 2016, 9 are SADC countries. South Africa has the largest number 

of new cases, 438,000, of whom 59% have HTV/ATDS, and a case rate of 781/100,000 

population. South Africa also has the largest number of MDR cases, 19,000 or an MDR rate of 

34/100,000. Case rates among the other SADC countries range from 728/100,000 in Lesotho to 

208/100,000 in Zimbabwe. ln addition to HlV/AlDS, an important risk factor for TB in SDAC 

countries is underground mining. Again, South Africa has the largest number of cases among 

miners. 

South Africa As a Model for TB Care and Investment 

XDR-TB was brought to the world's attention by a 2005 outbreak in rural K waZulu-Natal, South 

Africa. The strain, which was resistant to almost all anti-TB drugs in the country, occurred in an 

HIV-positive population and had a shocking mortality rate, killing 52 out of 53 patients, half of 

them within one month of diagnosis. By late 2006, XDR-TB cases were increasing throughout 

South Africa. In response, clinicians and public health staff in KwaZulu-Natal and at the local 

Church of Scotland Hospital developed and implemented a set of community-based care 

interventions that have become a global best practices model for drug -resistant TB care. The 

province's "Community Management ofMDR-TB Programme" used intensive case-finding of 

household contacts of patients and in congregate settings such as prisons and schools and 

specialist outreach teams to care for patients in their homes and screen and educate family 

members. South Atrica's tirst MDR-TB decentralized hospital was opened in KwaZulu-Natal 

region in 2007. This followed the opening of other specialized MDR-TB hospitals throughout 

South Africa with the goals of alleviating hospital bed shortages for MDR and XDR-TB patients 

and discharging patients to intensive community-based care within weeks. 

Very much to its credit, the South African government and researchers within the country have 

taken a proactive approach to addressing the TB epidemic and in this regard, are providing 

global leadership in research and in implementation of programmatic innovations. For example, 

South Africa now the majority of providers use rapid molecular testing to diagnose TB and to 

identify drug resistance. Moreover, the country has officially implemented one of the 2 new anti-
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TB drugs, bedaquiline, in the drug regimen for MDR TB, thereby avoiding the use of a highly 

toxic injectable drug. 

Although South Mrica continues to be one of the most highly burdened countries, including for 

drug resistant TB, under the leadership of Minister of Health Aaron Motsoaledi, the 

development and implementation of best practices throughout the country coupled a high level of 

political commitment and significant increase in funding for TB control and research and 

development, South Africa is a leader in global efforts to halt the TB pandemic. 

Internationally, as the Chair of the Stop TB Partnership Coordinating Board, Minister Motsoaledi 

was in large part responsible for a remarkable convening of ministers of health from most of the 

world's countries to focus on TB in Moscow in November 2017. This was an important step 

leading to the UN High Level Meeting on TB on September 26, 2018. Thus, South Africa is 

proving to be a leader not only of SADC countries but of the world in its aggressive approach to 

the TB epidemic. 

Need for New TB Tools 

Although effective drugs, and accurate diagnostic tests for TB exist, these technologies are 

inadequate for controlling the global epidemic. The World Health Organization, though the 

"End TB Strategy" has set the ambitious goal of ending TB as a disease of public health 

significance by 2035. This goal will not be reached without new tools, especially drug regimens 

for preventing TB that can be implemented in low resource settings and a vaccine that will 

protect against the disease. In addition there is an urgent need for new anti-TB treatments, 

particularly for shorter drug regimens with less toxic drugs for both drug-sensitive and especially 

drug resistant TB. Patients with MDR and XDR TB must be treated for up to two years with 

toxic drugs that can cause hearing loss and other severe side effects leading to low treatment 

success rates Although rapid molecular tests are available for diagnosing TB, their deployment 

has been limited by cost and complexity; thus, what is needed is a rapid, accurate point-of-care 

test suited to use in first level facilities where persons seek care. 

lJN High Level Meeting on Tuberculosis 

The September 26, 2018 United Nations High-Level Meeting on Tuberculosis (lJNHLM), the 

first-ever such meeting to be focused on the TB, is a unique opportunity to obtain commitments 

from heads of state to the ambitious global targets set by WHO to eliminate TB by 2035. The 

commitment requires that there be sufficient funding and high-level accountability to achieve the 

global goals. The ATS urges the U.S. to ensure robust funding commitments from countries, 

including for TB research and development and a strong accountability framework including the 

appointment of an independent eminent individual or panel appointed by the U.N. to oversee the 

publishing of an annual report on progress towards goals. Additionally, we urge the U.S. to send 

a high level U.S delegation to the UNHLM, that will include the Secretary of Health and Human 

Services and Directors of the National Institute of Allergy and Infectious Diseases and Centers 

for Disease Control and Prevention. 

Funding 
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The U.S. is providing strong global leadership on tuberculosis through the U.S. Agency for 

International development (USAID), Centers for Disease Control and Prevention (CDC), 

PEPFAR and the National Institutes of Health. But TB's position as a global health security 

threat requires increased commitment and investment. TB control, including research and 

development efforts, has historically been severely underfunded. FY2018 USAID global TB 

funding is $261 million, which is disproportionally low relative to other global health priorities 

and TB 's burden as the leading infectious killer. The Lantos-Hyde PEPF AR reauthorization, 

passed in 2008, authorized $4 billion over 5 years for TB, but annual funding appropriated has 

not come close to this. 

In December, 2015, the U.S. government released the inter-agency National Action Plan to 

Combat Multi-Drug Resistant (MDR) Tuberculosis (National Action Plan). The National Action 

Plan provides a comprehensive plan for combating drug resistant TB in the U.S. and abroad and 

for accelerating research and development to develop new TB diagnostic, treatment and 

prevention tools, but no funding was ever appropriated for its implementation. USATD has 

reached the key MDR-TB treatment targets for years one and two of the plan but has indicated 

that reaching year three to year five goals is not achievable under current funding. The continued 

global pandemic of this airborne infectious disease and spread of drug resistant TB demand that 

the U.S. strengthen our investment in global and domestic TB control and research to develop 

new TB diagnostic, treatment and prevention tools through USAID, CDC and NIH. 

Recommendations 

The A TS recommends the following: 

1) The U.S. should provide leadership to secure robust global targets for the detection, 

treatment and prevention of TB and funding and accountability political commitments 

from countries in the political declaration to be finalized at the September 26 2018 United 

Nations High-Level Meeting on Tuberculosis, including the appointment of an 

independent eminent individual or panel appointed by the U.N. to oversee the publishing 

of an annual report on progress towards the TB Political Declaration's goals. 

2) In order to begin to halt the TB pandemic and implement the National Action Plan we 

urge Congress to provide $400 million for USAID's TB program in FY2019. 

3) In order to provide a coordinated global TB investment, we recommend that Congress 

provide $21 million in specific line-item funding for CDC's global TB program 

4) Accelerate research and development efforts, including research goals under the National 

Action Plan, to develop new TB diagnostic, treatment and prevention tools by providing 

increased funding for NTH and CDC TB research efforts. 

5) Congress should direct the Biomedical Advanced Research and Development Authority 

(BARDA) to support late-stage TB diagnostic, treatment and prevention tool 

development. 

6) Enact the Comprehensive TB Elimination Act, H.R. 5794/S. 2506, to strengthen U.S TB 

control and implement the U.S. goals of the National Action Plan and put the U.S. on the 

path to TB elimination. 
53

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The A TS appreciates the opportunity to submit this statement to the subcommittee. For more 

information, please contact Nuala S. Moore with the American Thoracic Society at (202) 

296.9770 or Nmoore@thoracic.org 
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Questions for the Record- Ranking Member Eliot Engel 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

Answered by Ms. Irene Koek 

I. Is the US. on track to meet the goals of the US Government Global TB Strategy (2015-

2019) and the National Action Plan for Combating Multidrug-Resistant TB (2016-2020)? 

If not, what obstacles remain? 

Between 2000-2016, a 20% reduction in the TB incidence rate and a 30% reduction in the 

TB mortality rate was achieved in USAID's TB priority countries. These are significant 

achievements towards meeting the goals of the US. Government Global TB Strategy and 

the National Action Plan for Combating Multidrug-Resistant TB (MDR-TB). However, 

there are a number of obstacles that will likely prevent us from fully realizing all of the 

goals set forth in these strategies. One of the main obstacles is the lack of access to TB 

services beyond the government facilities to find all of the people with TB, MDR-TB, 

and TB/HIV quickly, particularly in the private, non-governmental and community 

sectors. Another obstacle is the lack of tools and technologies to better address the 

epidemic such as a point-of-care diagnostic, new and less toxic drugs, and a vaccine. 

USAID continues its etJorts to address these challenges. 

2. You note in your testimony that "[TB] predominantly atl'ects the poorest and most 

vulnerable, with about 95 percent of TB deaths occurring in low- and middle- income 

countries," and ''the longer people with active TB disease remain untreated, whether it is 

drug-susceptible (DS) or DR, the more likely they are to spread the disease, infecting 

their families and communities." Is it fair to say that the absence of atl'ordable treatments 

could hinder efforts to control TB? 

Current efl'orts to control TB are hindered by insufficient access to services and the 

appropriate tools to diagnosis and treat the disease. Treatment has become more 

affordable. Through the Global Drug Facility (GDF), supported by USAID, countries 

have access to high-quality and afl'ordable TB treatment GDF has worked diligently to 

negotiate price reductions in treatment for both drug-susceptible and drug-resistant TB. 

Last month, GDF announced 28 newly-signed agreements with manufacturers for 83 

products that will result in a savings of approximately $31 million in one year. The price 

of MDR-TB treatment regimens has declined more than 60 percent since 2012, while the 

price of some of the medicines to treat MDR-TB has fallen by 70 percent. By the end of 

2017, GDF had delivered more than 30 million treatment courses to 139 countries. GDF 

is the largest global provider of quality-assured tuberculosis medicines, diagnostics, and 

laboratory supplies to the public sector. 
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Questions for the Record- Ranking Member Eliot Engel 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

USAID's partnerships with the private sector have also played a key role in increasing 

rapid access to the few promising new tools entering the TB market For example, 

USAID has partnered with Johnson and Johnson to introduce bedaquiline, the first new 

TB drug approved by the Food and Drug Administration (FDA) in more than 50 years. 

USAID is also partnering with diagnostic companies such as Cepheid and Becton 

Dickinson to expand access to quality rapid testing for TB and drug resistant TB 

3. You note in your testimony that "In 2016, 82 percent of TB patients in the Africa region 

had a documented HIV test PEPF AR data indicate that about half of eligible patients on 

antiretroviral treatment (ART) were screened for TB in 2017'' What are the barriers to 

scaling these rates up to 100%? 

There has been remarkable progress in scaling up HIV testing of TB patients in the 

Atfican region. In the last ten years, HIV testing among TB patients has increased from 

40 percent to 82 percent. We expect this number to continue to increase as we continue 

to prioritize testing, especially in areas of high burdens ofH1V and TB. 

As an implementing agency ofPEPFAR, USAID is addressing the key barriers to scaling 

up TB screening and treatment of people living with HIV (PLHIV), as approximately half 

ofPLHIV on ART are currently screened for TB. All PLHIV that present for HIV care 

should be screened for TB and, if diagnosed with active TB disease, referred for 

immediate initiation of TB treatment PLHIV that do not have active TB disease should 

be immediately started on TB preventive treatment and then subsequently screened at 

every HIV care visit TB, as the leading killer ofPLHIV, requires intensive screening and 

treatment to reduce HIV mortality. 

4. According to the World Health Organization, there is an annual $2.3 billion gap between 

the resources needed for successful implementation of tuberculosis programs and what is 

currently being spent worldwide. However, the President's FY 2019 budget request 

included an $83 million cut to bilateral tuberculosis funding (compared with the FY 2018 

enacted level). How many fewer people would USAID be able to test for tuberculosis or 

treat for tuberculosis if this cut went into effect? 

USAID has been a catalyst for investment and change in high burden TB countries. Over 

80 percent offunding to support the TB response is financed through these countries' 

national domestic resources. We continue to work with all partners, including ministries 

of health; multilateral, private, non-profit, and faith-based organizations; and civil society 

to provide resources, expertise, and services to individuals with TB and those at risk of 
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Questions for the Record- Ranking Member Eliot Engel 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

1B. US AID views the control of TB as an important milestone on the journey to country 

self-reliance, and will be seeking opportunities to raise additional private capital to match 

USAID's investments. 

The focus of our available funding even in constrained scenarios is to provide support for 

the 22 high priority countries. With fewer resources, USAID would invest less in nonpriority countries, the roll-out of new tools, research and development, and direct less 

funding to enhance efforts by national governments to find missing TB patients among 

vulnerable and hard-to-reach populations. 

Answered by the Honorable Deborah L. Birx 

I. You note in your testimony that "PEPF AR has committed to addressing TB in Africa by 

dramatically increasing HIV/TB investments and activities over the past decade and more 

recently by aggressively scaling up antiretroviral therapy for all persons living with HIV 

and accelerating the roll-out ofTB preventive therapy." Will the PEPF AR Strateb'Y for 

Accelerating HIV I AIDS Epidemic Control (20 17 -2020) allow for these scale-ups to 

continue in all countries served by the PEPF AR program? 

PEPF AR remains committed to addressing TB as a top policy and programmatic priority. 

There has been an increase in the provision of TB preventive therapy to persons newly 

enrolling in HIV care, driven largely by the programmatic activities ofPEPF ARsupported countries. PEPF AR continues efforts to support the scale-up of the Cepheid 

GeneXpert M1B/RIF test, a fully automated, molecular diagnostic test for TB. This test 

enables programs to diagnose TB quickly, which can help reduce transmission and 

decrease mortality. 

PEPF AR recently revised its suite of 1B indicators and now requires our country teams 

to report on initiation and completion of TB preventive therapy as well as TB screening 

and initiation of TB therapy in those diagnosed with the disease. These additions were 

part of a deliberate attempt to drive programming and encourage fully integrated TBIHIV 

care in PEPF AR countries. Encouraging! y, despite no requirements for targets or 

advanced planning, I 7 countries initiated or expanded TB preventive therapy 

programming in FY 2017. 

We can prevent cases ofTB in the first place by scaling up antiretroviral therapy (ART), 

which reduces the risk that a person living with HlV will develop TB by around 65 

percent, and the addition ofTB preventive therapy to ART reduces the risk by 97 percent. 
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Questions for the Record- Ranking Member Eliot Engel 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

Among people living with HIV who do develop TB, early ART can halve the mortality 

rate, which is why testing for HIV and initiating ART are key interventions. 

2. You note in your testimony that "As recommended by the World Health Organization, 

PEPF AR is integrating TB/lllV care by providing care for both diseases in one clinic." In 

the event that integrated services are scaled back, or clinics that provide integrated care 

are closed, how might patient adherence to treatment regimens and care retention be 

affected? 

We are working to ensure that these integrated services are not scaled back From a 

country perspective, integration makes sense as care is provided in one of the two 

existing national program clinics (HIV or TB), so no new facilities are required; overall 

costs are lower and patient satisfaction is higher. Patient adherence for both HIV and TB 

is also supported by community healthcare workers and family members who are 

sometimes enlisted to support treatment adherence. We are developing cost-efl'ective 

interventions to help promote HIV adherence and community treatment, such as 

Community ART Refills Groups and Viremia clinics that focus on improving adherence 

in those with unsuppressed viral loads. These interventions will decongest clinics, 

allowing for greater numbers of patients enrolled into care within the same infrastructure. 

These interventions can also be used to support adherence to TB treatment 

3. You note in your testimony that "People whose immune systems are impaired from 

conditions like malnutrition and especially HIV infection are at particular risk of, and 

from, active TB disease." Is it fair to say that activities to prevent HIV infections may 

have the added efl'ect of reducing rates of active TB disease? 

Yes. HIV mal<es it much more likely that a person who is infected with the 

Mycobacterium tuberculosis (the organism that causes TB) will develop TB disease. 

This has epidemiologic implications; in Southern Africa, the HIV epidemic was a 

dramatic driver of the TB epidemic. Anything that reduces HIV transmission would be 

expected to lower the incidence of TB disease. Scale-up of antiretroviral therapy (ART) 

would lower the overall TB incidence rates by bolstering immune system functioning in 

those with HIV, thereby reducing the individual risk of developing TB disease, and by 

lowering HIV transmission, reducing the overall pool of people at enhanced risk. Our 

focus on dramatic scale-up of ART would be expected to reduce the incidence rates of all 

opportunistic infections. 
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Questions for the Record- Ranking Member Eliot Engel 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

4. You have made the use of data a cornerstone of your stewardship ofPEPFARspecifically, using data to pinpoint areas of greatest need and allocating funds 

accordingly. Is it fair to say that this use of data has helped improve the allocation of 

funds for TB!HIV care? 

Yes, we use our data to identify programs and specific sites that are performing below par 

and that require additional support and focused intervention. We are also able to identify 

programs (and sites) that are performing well in similar contexts, which allow us to elicit 

and share "best practices" with under-performing sites. We have also conducted 

mapping exercises to enable us to strategically place diagnostic equipment, enhancing 

capacity across all PEPF AR-supported countries. 

Answered by Dr. Rebecca Martin 

1. You note in your testimony that "CDC is a lead implementer of the National Action Plan 

for Combating Multidrug-Resistant Tuberculosis (NAP), which builds on the National 

Action Plan to Combat Antibiotic-Resistant Bacteria (CARB). CARB focuses on 

preventing the spread of resistant pathogens and includes activities to prevent the spread 

ofMDR-TB around the world." However, it is my understanding that the Biomedical 

Advanced Research and Development Authority (BARD A) and the Combating 

Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) have never 

otiered funding opportunities to product developers working on MDR-TB medical 

countermeasures, including drugs, diagnostics or vaccines. How could CDC work with 

BARD A to ensure that DR-TB is included as part ofBARDA's essential work on 

medical countermeasure development? 

The Centers for Disease Control and Prevention (CDC) is a lead implementer of the 

National Action Plan to Combat Antibiotic-Resistant Bacteria (CARB) alongside many 

operating divisions and agencies across the Department of Health and Human Services 

and the U.S. Government. In 2013, CDC published the Antibiotic Resistance Threats in 

the United States, 2013 report (https://www.cdc.gov/drugresistance/threat-report20 13/index.html), which provides information on the burden and threats posed by the 

antibiotic-resistant germs having the most impact on human health. Drug-resistant TB is 

highlighted in this report as a serious threat to the United States. 

The Office of the Assistant Secretary for Preparedness and Response (ASPR), through 

the Biomedical Advanced Research and Development Authority (BARD A) invests in the 

development of products to address antimicrobial resistance. BARD A has largely 
59

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Questions for the Record- Ranking Member Eliot Engel 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

focused on the research and development of novel antibiotics to stem the tide of 

antimicrobial resistant infections in both hospitals and in communities across the United 

States. These antibiotics are typically derivatives of existing classes of antibiotics that 

overcome known drug resistance mechanisms while also targeting one or more of the 

bioterrorism agents BARD A is tasked with addressing as part of its core 

mission. Additionally, the overall stratee\Y is to leverage the development of products for 

routine clinical use as a means of having products "at the ready" in the event of a 

bioterrorism event 

Many of the products that would be developed to prevent or treat TB do not possess the 

dual purpose of also addressing a bioterrorism pathogen. For example, bedaquilin, the 

most recently approved TB drug, is not predicted to have any activity against the five 

bioterrorism bacteria (anthrax, plague, tularemia, glanders, melioidosis) for which 

BARD A is tasked with developing medical countermeasures. 

Re-directing resources to address TB would come from an expense to other programs that 

address chemical, biological, radiological, and nuclear threats, pandemic int1uenza, and 

other emerging infectious diseases. 

In regard to CARB-X, TB is not currently in the scope ofCARB-X. However, in 

addition to substantial research investments by NT AID, there are other important groups 

with particular expertise addressing this challenge, including the Bill and Melinda Gates 

Foundation and TB Alliance. 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

Answered by Ms.lrene Koek: 

1. Deputy Administrator Koek The continued spread of drug resistant TB is a threat to 

global health security, with 480,000 cases of multi-drug resistant TB reported globally. 

Yet the WHO estimates that only about 25% of people with multi-drug (MDR) resistant 

TB globally are getting appropriately treated. Drug resistant TB is a problem for the US. 

too as in 2017 my state of CA reported 29 cases ofMDR-TB The National Action Plan 

to Combat MDR-TB, released in December 2015, provides a comprehensive roadmap for 

combating TB in the US., internationally and for accelerating research and development 

of new TB diagnostic, treatment and prevention tools. Is US AID on track to meet its 

overall target for treating 200,000 MDR-TB cases by 2020? What challenges exist that 

might make meeting this target difficult? 

While we have seen some progress, the proportion of people infected with MDR-TB who 

have not yet been diagnosed remains below what it should be, as are the number of 

patients who successfully completing their treatment The National Action Plan to 

Combat MDR-TB target is to treat an additional 200,000 MDR-TB builds upon a target 

of treating 360,000 MDR-TB patients in the US. Government Global TB Strategy. In 

the past year, USAID has seen a significant increase in improving the quality ofMDRTB treatment with the rapid uptake of new drugs and the shortened TB regimen. USAID 

did meet the Year 1 milestones but observed detection and treatment rates remained 

relatively unchanged in Year 2, in line with the global trends observed in 2017. Increased 

political will within the target countries and access to additional resources will be 

required for the rapid scale-up needed in 2018, and through the rest of the Plan to achieve 

the milestones laid out for Year 3. 

We are working with our partners to reach the goals developed in a collaborative effort 

across the US. Government Our work is focused on finding the missing TB cases 

globally, scaling up access to rapid MDR-TB diagnostic services, and enrolling patients 

on effective treatment In India, USAID piloted and scaled-up the first-ever use of 

GeneXpert to diagnose TB and MDR-TB in adults and children, leading to a new 

national policy. The support to pediatric case tinding with GeneXpert in India showed a 

4-fold increase in case detection ofMDR-TB in children- a disease that would otherwise 

have never been detected or detected too late for these children. USAID designed and 

implemented a Joint TB Diagnostic Network Assessment to identify interventions and 

priorities to assist the Government of India in operationalizing the diagnostic targets and 

goals in their National TB Strategic Plan. In addition, this assessment supports India's 

MDR-TB infrastructure expansion plan. On the treatment side, US AID supported the 

introduction ofbedaquiline for MDR- and XDR-TB patients in India. The introduction of 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

this life-saving medicine was done through a comprehensive package of support to 

clinicians and patients in facilities throughout India. The lack of access to quality TB 

services as well as the lack of point-of-care diagnostics and shorter and less toxic 

treatment are key barriers that prevent us from meeting our targets. We are working with 

partners including Cepheid and Becton Dickinson to address these challenges through 

increasing access to TB diagnostic services. For example, in India, our new Partnership 

with Becton Dickinson is helping to optimize testing for second-line drug resistance 

which is critically important to ensure that MDR-TB patients are placed on appropriate 

treatment Our partnership with Johnson and Johnson supports the roll-out of new 

treatments. 

2. A subsequent May 2018 report ±rom US AID on the National Action Plan for Combating 

Multi-Drug Resistant Tuberculosis states that in 2017 the rate of increase in expanding 

access to MDR-TB diagnosis and treatment has "remained relatively unchanged" and that 

"additional resources will be required" to reach further milestones. This is very 

concerning, since MDR-TB is a global health security threat For FY 18, Congress has 

provided an 8% increase to USAID's TB program, a boost of$20 million. For all the 

witnesses: What can be done to accelerate access to diagnosis and treatment for drug 

resistant TB, and what level of resources is required? 

Diagnosing MDR-TB starts with finding TB cases. Globally, we are only finding about 

two-thirds of estimated TB cases. The remaining one-third of TB cases are either not 

diagnosed or diagnosed but not reported. With the resources that are already available, 

USAID is supporting interventions to accelerate the detection ofMDR-TB, starting with 

finding the missing cases and improving access to drug susceptibility testing (DST). 

Through our person -centered approach, we are increasing awareness and addressing 

factors that are preventing persons with TB symptoms ±rom accessing TB diagnostic and 

treatment services. We are increasing active screening of TB and MDR-TB among 

vulnerable groups using ditl'erent strategies, including community-based screening, 

universal screening, and DST at health facilities using GeneXpert. Even though 

GeneXpert is not a point-of-care diagnostic test, countries can improve systems to allow 

every person with signs and symptoms ofMDR-TB access to GeneXpert testing. 

Improvements in systems like specimen referral and transport and diagnostic data 

management enable countries to use existing rapid molecular tests, like GeneXpert, to 

accurately diagnose MDR-TB and start appropriate treatment in much less time than 

traditional tests. By investing in these supportive systems, countries will be prepared to 

introduce new MDR-TB diagnostic tools, like sequencing, when they become available. 

However, in the long run, given the cost and infrastructure requirements of X pert, there is 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

a need to continue to invest in new, rapid and practical point-of-care TB screening and 

diagnostic tools. 

People with drug-resistant TB (DR-TB) can be deterred from starting treatment as DRTB treatment regimens are long, difficult and can involve serious side effects. To address 

this issue, USATD is supporting the development of new TB treatment regimens which 

are shorter and more tolerable to patients. These regimens are expected to result in 

increased treatment adherence and higher cure rates. Additional funds will continue to 

support clinical trials to evaluate new drugs and ensure that the drugs are accessed by 

those most in need. 

3. When a woman becomes pregnant her chance of developing TB doubles. People who are 

malnourished, including children, are also known to be much more vulnerable to TB. For 

Ambassador Birx and Deputy Administrator Koek, how are your agencies working to 

integrate TB screening and other TB services into programs meeting the needs of orphans 

and vulnerable children and pregnant women? How are your programs working to break 

down siloed health programs and integrate TB into other global health programs? 

Finding all people without access to services (the missing TB patients) is a priority for 

USAID's TB program. We are supporting interventions to reach vulnerable and 

marginalized populations including people living with or affected by HIV, mine workers, 

pregnant women and children. 

We have integrated TB screening services within primary health care services and 

maternal and child health services, including antenatal clinics and child and well-baby 

clinics. Diagnosis of TB in children remains more ditlicult than in adults. However, we 

are using evidence from recent studies to improve our ability to identify the disease in 

children, and we have supported the development of new pediatric fonnulations to make 

appropriate treatment widely available. 

With regard to pregnant women, we have engaged with partners from USAID's 

reproductive health programs to advocate and promote TB screening during pregnancy 

and after childbirth. We are supporting the gathering of evidence on the efficacy and 

safety of new TB drugs to inform future treatment guidelines for this population. 

We are supporting the screening of people living with HlV (PLHlV) for TB as part of 

ongoing, routine care and addressing barriers/challenges to TB screening for PLHlV. 

Current guidelines delineate procedures for PLHIV who screen positive for TB. If 

further evaluation indicates active TB disease, treatment is initiated as soon as possible. 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

Tfthe evaluation does not indicate active disease, providers are directed to begin TB 

preventive therapy. 

We are working with a wide range offaith-based and community organizations to reach 

families and communities, and prioritizing finding "missing" TB patients among 

vulnerable, hard-to-reach and marginalized populations, including people living with 

HTV, mineworkers, pregnant women, and children. And we are reaching beyond 

Ministries of Health to include Ministries of Labor to reach manufacturers and workers, 

Education for teachers and children, correctional agencies for prisoners and guards, faithbased and community organizations to reach families and communities, and the corporate 

sector to include mining enterprises, the pharmaceutical industry and private healthcare 

providers. 

4. Private sector companies have been reluctant to make risky investments in researching 

new TB cures. The market dynamics of TB -a disease that affiicts mainly the poormake it likely that companies won't be able to recoup their R&D investments. 

For all the witnesses, given this situation, what more should we do to incentivize private 

sector companies to invest in TB research? 

USAID continues to leverage American innovation and leadership to improve the 

quality of diagnosis and treatment through the scale-up of new tools. In a joint effort 

witb Johnson and Johnson, the Agency has utilized its extensive delivery platform to 

increase the introduction and scale-up of bedaquiline in over 70 countries. In addition, 

Johnson and Johnson is utilizing USAID's research platform for the Phase III clinical 

trial of bedaquiline, maximizing limited TB tun ding. US AID is also partnering with 

diagnostic companies, such as Cepheid and Becton Dickinson, to expand access to 

quality, rapid testing for TB and drug resistant -TB. These type of partnerships are a 

win-win for the private and the public sectors. 

5. For all the witnesses, to what degree do you think the price of medicines is a factor 

driving the overall cost of treating TB? How signit!cant are drug costs compared to other 

barriers to access of treatment? 

With significant USAID support, the Global Drug Facility has changed the landscape of 

TB care since its creation in 200 I by increasing access to high quality and affordable 

TB treatments and diagnostics for populations in need. By the end of2017, GDF 

delivered more than 30 million treatment courses to 139 countries. The average price 

for a six-month course of quality-assured drug-susceptible TB treatment from GDF is 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

$35 The price of some medicines for drug-susceptible TB has fallen by 70 percent 

GDF is the largest global provider of quality-assured tuberculosis medicines, 

diagnostics, and laboratory supplies to the public sector. The GDF is a pooled 

procurement mechanism that provides a package of services, including technical 

assistance in TB drug management and monitoring of drug use, as well as procurement 

of high-quality TB drugs at low cost. As the largest supplier ofTB medicines and 

diagnostics, GDF ensures the availability, affordability and quality ofTB medicines 

The MDR-TB drug supply is considered a fragile and orphan market because of its 

small size and low profit. It is further hampered by the fact that each patient requires 

many drugs for a long period of time. Despite this, last month GDF announced 28 

newly-signed agreements with manufacturers for 83 products that will result in a 

savings of approximately $31 million in one year. The price of MDR-TB treatment 

regimens has declined by more than 60 percent since 2012. These price reductions are 

only possible because GDF serves as a pooled procurement mechanism for qualityassured tuberculosis medicines, diagnostics, and laboratory supplies globally. By the 

end of 2017, GDF delivered more than 30 million treatment courses to 139 countries. 

The small number of new TB drugs coming to market in recent decades is very 

concerning, and I would like to know how it affects your programmatic work. 

6. For all the witnesses, how would you describe and characterize the current situation of 

available TB treatments as well as what you see as the prospects for new treatments and 

their availability? 

The current TB treatment landscape has been composed of old and toxic generic drugs 

for many years. Particularly for MDR-TB, the situation has been quite dire, since most of 

the drugs, until recently, were not initially developed for that purpose. The long duration 

ofMDR-TB treatment and severe adverse events associated with these drugs are major 

barriers to treatment success. There have been two new drugs developed (bedaquiline and 

delamanid) and until recently they were only internationally recommended for a small 

number of drug-resistant patients. The broader availability of these drugs and their use 

have offered life-saving treatment options to those with the worst types of drug 

resistance. USA !D's support has made these drugs available through the Global Drug 

Facility (GDF). As more data become available, countries will update their treatment 

guidelines to recommend broader use for these new drugs. In addition, USAID and 

others are supporting clinical trials to determine the most optimal regimen using existing 

and new drugs. 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

There has been a decrease in the number of private pharmaceutical companies that are 

investing in developing new TB drugs given that the TB market is considered to be less 

profitable. Nevertheless, we are seeing a small increase in the number of new compounds 

that are being evaluated for their efficacy against TB, though these compounds will likely 

take more than 5 years to be approved for use in TB treatment. 

Answered by the Honorable Deborah L. Birx 

1. A subsequent May 2018 report from US AID on the National Action Plan for Combatting 

Multi-Drug Resistant Tuberculosis states that in 2017 the rate of increase in expanding 

access to MDR-TB diagnosis and treatment has ''remained relatively unchanged" and that 

"additional resources will be required" to reach turther milestones. This is very 

concerning, since MDR-TB is a global health security threat. For FY 18, Congress has 

provided an 8% increase to USAID's TB program, a boost of$20 million. For all the 

witnesses: What can be done to accelerate access to diagnosis and treatment for drug 

resistant TB, and what level of resources is required? 

PEPF AR collaborates with USAID on TB programming, and we can leverage etTorts to 

maximally impact the MDR-TB epidemic. Access to diagnosis and access to etTective 

treatment are two critical bottlenecks. Molecular testing that can detect both TB disease 

and rifampicin-resistance, the hallmark ofMDR-TB, is an important focus for PEPF AR, 

and we are currently working with USAID to improve access to, and maintenance of, 

such platforms in all of our countries. We are optimizing the use of these platforms (e.g., 

the GeneXpert platform), but still need to ensure that all HIV facilities have access to 

molecular testing, and this will require strategic development of specimen transportation 

systems as well as procurement of additional machines- both of which require resources. 

Based on results from USAID-supported studies, PEPF AR supports the use of the 

shorter, less expensive and less toxic treatment regimens for MDR-TB, and we will be 

promoting these regimens for our patients with MDR-TB. 

2. When a woman becomes pregnant her chance of developing TB doubles. People who are 

malnourished, including children, are also known to be much more vulnerable to TB. For 

Ambassador Birx and Deputy Administrator Koek, how are your agencies working to 

integrate TB screening and other TB services into programs meeting the needs of orphans 

and vulnerable children and pregnant women? How are your programs working to breal< 

down siloed health programs and integrate TB into other global health programs" 

All persons living with HIV, including and especially pregnant women, are reb•t!larly 

screened for symptoms ofTB disease at each visit. We follow this indicator closely, and 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

work to improve screening when performance is sub-par. Outside of those in HTV 

treatment, we include educational programming on TB for orphans and vulnerable 

children and for the adolescent girls and young women who participate in our DREAMS 

programs. We are actively working to integrate TB and HIV programs, which are still 

separate, even at the clinical level, in many of the countries where we work. 

3. Private sector companies have been reluctant to make risky investments in researching 

new TB cures. The market dynamics of TB- a disease that affiicts mainly the poormake it likely that companies won't be able to recoup their R&D investments. For all the 

witnesses, given this situation, what more should we do to incentivize private sector 

companies to invest in TB research? 

There is a potentially robust market for TB diagnostics, and we should try to incentivize 

the development of new products by demonstrating the size of the market (-20 million 

people living with HIV [PLHIV] on treatment, and growing). It is also worth 

highlighting that both PEPF AR and Global Fund funding can be used for TB diagnosis 

and treatment among PLHIV. Additional support for non-profit enterprises could greatly 

accelerate progress in both TB diagnosis and treatment 

4. For all the witnesses, to what degree do you think the price of medicines is a factor 

driving the overall cost of treating TB? How significant are drug costs compared to other 

barriers to access of treatment? 

The drug costs for drug-resistant TB are indeed prohibitive, and probably one of the 

biggest barriers to treatment The drug costs for drug-susceptible TB (DS-TB) are not a 

significant barrier; forDS-TB, the biggest barrier is finding the undiagnosed cases that 

are in the community. Many patients, particularly men, do not come to care unless they 

are disabled or unremitting! y ill; those that have TB often have infectious disease for 

many months before they come for care. The cost of community screening and casefinding is significantly higher and more prohibitive than the drug costs for DS-TB 

treatment 

5. The small number of new TB drugs coming to market in recent decades is very 

concerning, and 1 would like to know how it affects your programmatic work. We are 

somewhat encouraged to see a handful of new drugs making their way through 

development, but certainly the pace has not kept up with the need. We still have 60-yearold regimens that require 6 months of up to 4 drugs, and we are in urgent need of shorter, 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

more effective regimens. The pill burden introduced by TB disease can diminish 

treatment adherence for both TB and HIV, as patients get overwhelmed and weary from 

taking so many medicines, and this has impacted our programmatic work in the TB!HIV 

population. Furthermore, there is a growing concern about multidrug-resistant TB, which 

is an increasing threat in Southern Africa. Without new drugs, we will most certainly 

have an increasing number of patients demonstrating resistance to all available drugs who 

we will not be able to treat These patients are at very high risk of death and pose 

immediate threats to their families and communities. 

6. For all the witnesses, how would you describe and characterize the current situation of 

available TB treatments as well as what you see as the prospects for new treatments and 

their availability? How does the environment for new TB drugs challenge the programs 

you oversee in Southern Africa? Finally, how do these same challenges affect our own 

ability to treat TB, including virulent and drug resistant strains? 

Response: TB is, by far, the biggest killer of people living with HIV (PLHIV), especially 

in Southern Africa; this presents a direct challenge for PEPF AR, the purpose of which is 

to save the lives ofPLHIV and restore communities devastated by the HIV. Unless we 

have shorter, more etl'ective regimens against TB disease, TB will remain an enormous 

obstacle to achieving our goals. It is encouraging that there are a number of TB drugs in 

the pipeline, and there is emerging evidence that new combinations of currently available 

drugs are highly effective, and may allow for all oral, short duration treatment for many 

patients with drug resistant TB. But almost all of the new drugs are years away from 

being widely available, and we have patients with extensive drug resistance patterns that 

are untreatable by currently available drugs. These patients are often actively 

transmitting disease, so the current situation of drug-resistant TB is an urgent one. We 

need additional research to bring more drugs under investigation and to accelerate the 

timeline to drug availability and we need pricing that makes these drugs accessible to 

countries with limited tinancial capacity. 

Answered by Dr. Rebecca Martin 

1. A subsequent May 2018 report from US AID on the National Action Plan for Combatting 

Multi-Drug Resistant Tuberculosis states that in 2017 the rate of increase in expanding 

access to MDR-TB diagnosis and treatment has "remained relatively unchanged" and that 

"additional resources will be required" to reach further milestones. This is very 

concerning, since MDR-TB is a global health security threat. For FY 18, Congress has 

provided an 8% increase to USAID's TB program, a boost of$20 million. For all the 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

witnesses: What can be done to accelerate access to diagnosis and treatment for drug 

resistant TB, and what level of resources is required? 

The US Government released the National Action Plan for Combating MultidrugResistant (MDR) TB in 2015, laying out ambitious targets for accelerating etl'orts to find, 

cure, and prevent MDR TB through on-the-ground service delivery, technical support to 

Ministries of Health, and through research and innovation. The National Action Plan 

identifies areas where the U.S. Government can leverage its demonstrated experience and 

expertise to have the highest impact on the global epidemic. 

Fighting TB is considered one of the "best buys" in public health and development 

because of the expected $43 return on investment in improved health outcomes for every 

dollar spent Governments of high-burden countries have recognized this, contributing 

80 percent of the total global funding for addressing TB. The US. Government remains 

the largest international donor through bilateral and multilateral funding arrangements. 

However, there remains a global funding shortfall for all fonns of TB. The World Health 

Organization (WHO) estimates that there is an annual funding gap for TB interventions 

of $2.3 billion. If filled, this gap would enable full treatment for 17 million TB and 

MDR-TB patients and save six million lives over three years. 

2. Dr. Martin, given the ongoing TB challenge within the US, with more than 9,000 cases 

this past year, are the CDC resources for both global and domestic TB adequate? 

Funding for global and domestic TB supports the priority areas of enhancing TB treatment, 

diagnostic tools, prevention, and program delivery. Global Tuberculosis activities are 

supported by funding from CDC'S HNI AIDS, Viral Hepatitis, Sexually Transmitted 

Infections, and Tuberculosis budget Tn addition, CDC leverages its work in PEPFAR to 

address HIV/TB coinfection CDC will continue to strategically direct its resources to seek 

new innovative activities to advance the priority areas and prevent the spread of TB. CDC 

will target funding for global TB to finding cases, particularly for high-risk populations, and 

improving diagnostic algorithms; curing TB by optimizing TB and MDR-TB treatment 

regimens; improve linkage to care and treatment, especially among people living with HIV 

and preventing TB through implementing etl'ective TB infection control practices in health 

facilities and congregate settings and scaling-up preventive therapy for people living with 

HIV and children. 

3. Private sector companies have been reluctant to make risky investments in researching 

new TB cures. The market dynamics of TB- a disease that afflicts mainly the poormake it likely that companies won't be able to recoup their R&D investments. For all the 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

witnesses, given this situation, what more should we do to incentivize private sector 

companies to invest in TB research? 

The major disincentives to TB drug development are a small domestic market, a 

reasonably large global market but with most of the disease occurring in low income 

individuals in developing countries and a fixed treatment course (usually months as 

compared to lifetime treatment for other diseases such as diabetes and asthma). As 

indicated in the question, the high costs of R&D coupled with the high costs of regulatory 

approval relative to potential revenue in the current market make it difficult to recoup 

these investments. Directly or indirectly subsidizing R&D and regulatory approval costs 

could make TB drug development more attractive. Indirect subsidization through 

government funding of clinical trials and other research already occurs. For example, the 

CDC Tuberculosis Trials Consortium conducts clinical treatment trials ofTB drugs that 

have led to new treatment regimens and have been used as evidence necessary for 

regulatory approvaL Continuing these types of activities could help to increase 

opportunities for private sector development 

4. For all the witnesses, to what degree do you think the price of medicines is a factor 

driving the overall cost of treating TB? How signif!cant are drug costs compared to other 

barriers to access of treatment? 

Overall, TB is costly to treat In the US., a case of drug susceptible TB costs $18,000 to 

treat; multi drug-resistant TB costs $160,000 to treat, and extensively drug-resistant TB 

costs $513,000. Drug costs are a significant driver of the treatment costs for multi drug 

and extensively drug-resistant TB compared to drug-susceptible TB. Local and state 

health departments serve as the provider of last resort for these drugs. The cost of drugs 

for drug-resistant TB can have a substantial impact on health department budgets. The 

cost to treat TB internationally varies by location. 

The length ofTB treatment (6-9 months) requires substantial public health resources to 

ensure completion of treatment Additional services and testing necessary to ensure 

treatment to cure, including clinic visits, directly observed therapy, transportation, 

housing, hospitalization, x-rays, blood tests, cultures and drug susceptibility testing, 

account for the remainder of costs beyond drugs. Drug-resistant treatment is even longer 

(18-24 months).Toxicity of current drugs also adds to costs by causing interruption and 

extension ofTB treatment, potential need to change to more costly second-line drugs and 

interventions to address the toxicity that could include hospitalization. Local and state 

health departments work to overcome barriers to access domestically by ensuring 

necessary treatments and services are available regardless of a patient's financial or social 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

situation. Without this dedicated public health infrastructure, the burdens for access to 

care would likely include more barriers in addition to cost (drugs and other) as mentioned 

above. In many low and middle-income countries, other factors such as stigma, lack of 

knowledge about TB, extreme poverty, opportunity cost to access health services, lack of 

high quality drugs and diagnostics, inequality in access to the health services, and distrust 

with the health system become critical barriers to treatment. 

5. The small number of new TB drugs coming to market in recent decades is very 

concerning, and I would like to know how it affects your programmatic work. For all the 

witnesses, 

a) How would you describe and characterize the current situation of available TB 

treatments as well as what you see as the prospects for new treatments and their 

availability? 

Both domestically and globally, the treatment for drug-susceptible TB is very effective if 

administered correctly, achieving 95% cure. However, the regimen is relatively long, at 

least 6 months, and requires multiple drugs that have potential significant toxicity, such 

as liver damage. The length and complexity of the regimen require substantial ancillary 

services to ensure completion and cure because treatment failure is often associated with 

acquisition of drug resistance and transmission of disease to others. Regimens for 

multidrug-resistant TB are less effective, more toxic, take much longer (18-24 months) 

and are substantially more expensive. Therefore, patients and TB programs would benefit 

greatly from new drugs that allowed a much shorter treatment with less toxicity, which 

ideally could be used for drug-susceptible and drug-resistant TB. Also of concern, many 

TB drugs have a single U.S. manufacturer, making them vulnerable to shortages. When 

patents expire, manufacturers may sell the license or discontinue making the drug 

altogether. 

There are several new regimens that are being studied by various research entities 

including CDC. Studies include new drugs, new combinations of drugs and repurposing 

of older drugs. It is hoped that some new regimens will be available within the next five 

years. However, the overall pipeline of potential new drugs is sparse and clinical trials 

capacity is limited. More candidate drugs and research capacity are needed to transform 

TB treatment as happened with HIV treatment. 

CDC has ongoing activities addressed at both the development of new drug regimens and 

mitigating drug shortages. The former activity includes research on both treatment for 

latent TB infection to prevent progression to TB disease and treatment ofTB disease. 
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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

• CDC conducts clinical, operational, and laboratory research to develop better tools 

and operationalizing their use in TB programs. For example, CDC's TB Trials 

Consortium identified a shortened regimen for preventing TB disease among people 

who have latent TB infection and is now being used in the US and globally. In June 

2018, based on new CDC research, CDC updated guidelines for expanding use of this 

regimen for children over 2, people with HIV infection, and delivery by either selfadministration or directly observed therapy. 

• CDC is working with TB programs and private healthcare providers to offer shortcourse LTBl treatment to people at risk for developing TB disease. The regimen is 

easier to tolerate and more likely to be completed by patients and is far less costly 

than treating a case of TB disease ($600 for testing and treatment of latent TB 

infection as opposed to $18,000 to treat TB disease) 

• CDC is currently conducting a study of two new regimens for TB disease that would 

cut the duration of treatment by one third to 4 months. Enrollment in the study should 

be completed at the end of2018 with results being available in 2020. 

b) How does the environment for new TB drugs challenge the programs you oversee in 

Southern Africa" 

The standard treatment regimen for drug-resistant TB is long, toxic, and costly. The 

treatments often can last up to two years with daily injections that can cause severe 

side effects at a cost of up to $500,000 for a single case in the United States. Such 

treatments also drain health resources, requiring long hospital stays and years-long 

community care. Recently approved new drugs- Delaminid and Bedaquiline- offer 

the potential for shorter regimens with higher treatment success rates. Several clinical 

trials, including most recently in South Africa, have shown regimens including 

Bedaquiline to be more efficacious with fewer side effects, higher completion, and 

lower mortality rates than the standard regimen. These drugs have not been tested for 

use in children, and there remain no pediatric formulations for the 33,000 children 

globally who develop drug-resistant TB each year. Moreover, overall treatment costs 

remain a challenge in high-burden countries-- even though the individual drugs are 

generally available at low cost at present Because treatment involves multiple drugs, 

and also involves careful supervision, in part due to concerns that widespread use 

could lead to resistance if not administered properly, quality care can be a relatively 

expensive proposition in many settings. Clinicians and TB programs worldwide are 

weighing the risk of widespread use of these new drugs. In June 2018, South Africa, 

working with international partners, became the first country to replace the standard 

MDR-TB regimen with the shorter MDR-TB regimen incorporating Bedaquiline. 

These are promising developments in addressing treatment for drug-resistant TB, but 
72

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Questions for the Record- Rep. Bera 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

further research and development efforts for new innovative tools for both prevention 

and treatment is needed. 

c) Finally, how do these same challenges affect our own ability to treat TB, including 

virulent and drug resistant strains? 

Most domestic TB programs have faced challenges obtaining drugs for treating 

patients with drug resistant TB. These include nationwide shortage, shipping delays, 

and expense to programs and patients. Locating the appropriate drugs as rapidly as 

possible is imperative in order to halt transmission of drug resistant TB and to cure 

the patient CDC established a TB emergency drug stockpile to aid TB programs 

atfected by drug shortages. CDC activated this stockpile in March 2018 in response to 

a rupture in rifapentine supply at several U.S. distributors that threatened to interrupt 

treatment for patients on latent TB infection therapy. Since partial treatment is 

ineffective these patients would have needed to restart their regimens once supplies 

were re-established--a net loss for them and the TB programs. Partial treatment also 

could lead to the development of resistance to these first line treatments. Therefore, 

CDC provided rifapentine from the stockpile to affected programs, enabling over 530 

patients in 12 states to complete therapy, alleviating this critical shortage. 
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Questions for the Record- Rep. Castro 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

Answered by Ms. Irene Koek 

1. How many individuals do current US. global health programs support? 

Multiple agencies contribute to the implementation of U.S. global health programs. 

Currently, CDC works in more than 60 countries with over 1700 staff, collaborating with 

a wide array of partners to coordinate global health strategies, tactics and priorities with a 

sole focus on global health. Our global programs are run by world experts in 

epidemiology, surveillance, informatics, laboratory systems, and other essential 

disciplines to provide strong global health leadership capacity The work of these experts 

strengthen critical public health services around the world. Our global programs address 

more than 400 diseases, health threats, and conditions that are a major source of death, 

disease, and disability- building upon our U.S. public health program expertise and 

knowledge of these diseases to help protect Americans from major health threats, 

wherever they arise. CDC's National Center for Immunization and Respiratory Diseases 

cooperates with more than 50 countries to improve surveillance and response for 

influenza, both seasonal viruses and novel viruses with pandemic potential, and works in 

dozens of countries to promote introduction of vaccines for diseases including HPV and 

rotavirus. Within the CDC's Center for Global Health (CGH), the Global Immunization 

Division (GlD) works through partners across the world to protect against contagious and 

life-threatening vaccine-preventable diseases- saving an estimated 2 to 3 million lives 

each year. The Division of Global Health Protection (DGHP) collaborates with global 

partners to protect the U.S. from deadly and costly public crises by strengthening the 

capacity of other countries to prevent, detect, and respond to disease threats. Moreover, 

the Division of Parasitic Diseases and Malaria (DPDM) works to reduce the threat of 

parasitic diseases and to eliminate the global burden of malaria and neglected tropical 

diseases. This includes co-implementation of the President's Malaria Initiative (PMI). In 

addition, through PEPFAR, CDC and the Division of Global HTV/TB (DGHT) has 

supported 7.3 million people on antiretroviral therapy, TB screening for 4.7 million 

people living with HlV (PLHlV), including 400,000 children. ln 2017, PEPFAR 

provided 650,000 PLHIV with TB Preventive Treatment (TPT). 

2. How many fewer individuals would US. global health programs support, if funding 

levels and prioritization reflected the President's budget request? 

CDC works to provide the highest quality global health programs to achieve the greatest 

impact on reducing uncontrolled outbreaks of infectious diseases. Should the funding 

levels and prioritization reflected in the 2019 President's Budget become enacted, CDC 
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Questions for the Record- Rep. Castro 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

will continue to leverage its resources and support critical global health programs at a 

reduced scope. 

3. Which individual at your agency currently coordinates your agency's participation in the 

Global Health Security Agenda (GHSA) and with which individual and office at NSC 

does your agency coordinate with on matters related to the GHSA? 

ln pattnership with U.S. government agencies, other nations, international organizations, 

public and private stakeholders, CDC seeks to accelerate progress toward a world safe 

and secure from infectious disease threats. CDC has a number of staff across programs 

that work on GHSA. Within the Center for Global Health (CGH), the Associate Director 

for Global Health Security coordinates with subject matter and technical experts 

throughout the agency to implement GHSA. It is the role of the Associate Director for 

Global Health Security to coordinate both efforts within CGH and across the agency. The 

Associate Director for Global Health Security also coordinates CDC cooperation with the 

Weapons of Mass Destruction & Biodefense office within the NSC. 

4. What efforts, if any, do you cooperate or collaborate with the Global Development Lab at 

USAID on? 

CDC currently does not collaborate with US AID's Global Development Lab. 

Answered by the Honorable Deborah L. Birx 

How many individuals do current US global health programs support? 

Today, after 15 years, PEPF AR supports more than 14 million men, women, and children 

with lifesaving HIV treatment- more than twice as many as 4.5 years ago. When 

PEPF AR began, only 50,000 people in Atrica were on lifesaving HIV treatment 

PEPF AR is not only saving lives by treating HIV, but also by stopping transmission 

before it happens, including through three primary prevention interventions 

PEPF AR continues to be the driving force in preventing mother-to-child transmission. 

To date, PEPF AR has enabled more than 2.2 million babies to be born HIV -negative to 

HIV-positive mothers and kept their mothers alive through t provision oflifesaving 

antiretroviral treatment 

To prevent new infections in boys and men, PEPF AR has supported more than 15.2 

million of them through the provision of voluntary medical male circumcision (VMMC), 
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Questions for the Record- Rep. Castro 

Combatting Tuberculosis in Southern Africa 

July 12, 2018 

including through the largest single-year increase (nearly 3.5 million) in VMMC results 

during fiscal year (FY) 2017, since the beginning of PEPF AR 

To prevent infection in adolescent girls and young women, PEPF AR designed the 

groundbreaking DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, 

and Safe) public-private partnership. In nearly two-thirds of PEPFAR-supported 

DREAMS districts in 10 African countries, new HIV diagnoses are down 25-40 percent 

or more among adolescent girls and young women since 2015. 

2. How many fewer individuals would U.S. global health programs support, iffunding 

levels and prioritization reflected the President's budget request? 

With the President's budget request the United States will continue to be the single 

largest donor to global HIV/ AIDS relief efforts The requested levels will allow 

PEPF AR to maintain all patients currently on antiretroviral treatment (ART). It will 

support the continuation of US. HIV/AIDS relief efforts in more than 50 countries 

through direct bilateral and regional programs, and the Global Fund. 

Tn addition to maintaining the current ART service delivery levels across PEPFAR 

countries, PEPFAR will continue to work toward achieving epidemic control in 13 high 

HIV/AIDS burden countries, in line with the Administration's new PEPF AR Strategy for 

Accelerating HIV/ AIDS Epidemic Control (2017-2020). In addition to saving millions of 

lives, this strategy will reduce the future costs required to sustain the HIV/AIDS 

response. 

3. Which individual at your agency currently coordinates your agency's participation in the 

Global Health Security Agenda (GHSA) and with which individual and office at NSC 

does your agency coordinate with on matters related to the GHSA? 

Tn my role as Coordinator of the United States Government Activities to Combat 

HIV/ATDS and US Special Representative for Global Health Diplomacy Twork closely 

with the Bureau of Oceans and International Environmental Scientific Affairs and 

Department leadership to ensure all Global Health Security issues are coordinated with 

the NSC. 

The health systems supported by PEPFAR are on the front lines of"detecf' within the 

global health security agenda. PEPFAR has built health infrastructure and strengthened 
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capacity through an emphasis on sustainability. This infrastructure and capacity not only 

support people living with HIV I AIDS, but also are leveraged for maternal and child 

health, tuberculosis, malaria, immunizations, and emergency disease outbreak responses. 

We invest in robust laboratories and well-trained laboratory specialists critical to wellfunctioning health systems, enabling clinicians and health workers to better diagnose and 

treat a range of diseases and conditions. PEPF AR has trained nearly 250,000 health care 

workers to deliver and improve HTV care and other health services, creating a lasting 

infrastructure that enables partner countries to address all health challenges of today and 

tomorrow. 

In 2017 alone, through PEPFAR's COPs/ROPs, we invested nearly $600 million in 

health system strengthening investments, including nearly $100 million to strengthen 

laboratory systems. These efforts have also strengthened the ability of countries with 

sizable HTV/ATDS burdens to swiftly address other outbreaks, such as Ebola, avian flu, 

and cholera, ultimately enhancing global health security and protecting America's 

borders. These critical health systems investments have enabled PEPF AR to directly 

support the global health security agenda. 

4. What efforts, if any, do you cooperate or collaborate with the Global Development Lab at 

USATD on? 

PEPF AR has cooperated over the years in a variety of capacities with the Global 

Development Lab. A few years ago when PEPF AR convened subject-specific 

interagency Technical Working Groups (TWGs), there was a representative from the Lab 

on the Public Private Partnership TWG. While the TWG structure is no longer active, we 

often still consult with the Lab on various partnerships and innovations. More recently, 

when PEPF AR was in the early stages of launching the DREAMS Innovation Challenge, 

we consulted with the Lab on the structure, design, process, criteria, and timelines of 

running an innovation challenge/prize competition. 

Additionally, PEPFAR is an active participant every year in Global Partnership Week 

(GPW), which is co-hosted by the Secretary's Office of Global Partnerships at the US 

Department of State, the Global Development Lab, Concordia, and Peace Tech Lab. 

GPW brings together leaders and practitioners from multilateral organizations, civil 

society, and corporations to celebrate uncommon solutions to accelerating public-private 

partnerships from start to scale. Finally, PEPF AR has participated in several events 

hosted by the Lab, including those related to the Global Innovation Exchange. Overall, 
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the relationship between PEPF AR and the Global Development Lab is strong and we 

look forward to continued collaboration. 

Answered by Dr. Rebecca Martin 

1. How many individuals do current U.S. global health programs support? 

Multiple agencies contribute to the implementation of U.S. global health programs. 

Currently, CDC works in more than 60 countries with over 1700 staff, collaborating with 

a wide array of partners to coordinate global health strategies, tactics and priorities with a 

sole focus on global health. Our global programs are run by world experts in 

epidemiology, surveillance, informatics, laboratory systems, and other essential 

disciplines to provide strong global health leadership capacity The work of these experts 

strengthen critical public health services around the world. Our global programs address 

more than 400 diseases, health threats, and conditions that are a major source of death, 

disease, and disability- building upon our U.S. public health program expertise and 

knowledge of these diseases to help protect Americans from major health threats, 

wherever they arise. CDC's National Center for Immunization and Respiratory Diseases 

cooperates with more than 50 countries to improve surveillance and response for 

influenza, both seasonal viruses and novel viruses with pandemic potential, and works in 

dozens of countries to promote introduction of vaccines for diseases including HPV and 

rotavirus. Within the CDC's Center for Global Health (CGH), the Global lmmunization 

Division (GID) works through partners across the world to protect against contagious and 

life-threatening vaccine-preventable diseases - saving an estimated 2 to 3 million lives 

each year. The Division of Global Health Protection (DGHP) collaborates with global 

partners to protect the U.S. trom deadly and costly public crises by strengthening the 

capacity of other countries to prevent, detect, and respond to disease threats. Moreover, 

the Division of Parasitic Diseases and Malaria (DPDM) works to reduce the threat of 

parasitic diseases and to eliminate the global burden of malaria and neglected tropical 

diseases. This includes co-implementation of the President's Malaria Initiative (PMI). In 

addition, through PEPF AR, CDC and the Division of Global HIV /TB (DGHT) has 

supported 7.3 million people on antiretroviral therapy, TB screening for 4.7 million 

people living with HIV (PLHIV), including 400,000 children. In 2017, PEPF AR 

provided 650,000 PLHIV with TB Preventive Treatment (TPT). 

2. How many fewer individuals would U.S global health programs support, if funding 

levels and prioritization reflected the President's budget request? 

CDC works to provide the highest quality global health programs to achieve the greatest 

impact on reducing uncontrolled outbreaks of infectious diseases. Should the funding 

levels and prioritization reflected in the 2019 President's Budget become enacted, CDC 
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will continue to leverage its resources and support critical global health programs at a 

reduced scope. 

3. Which individual at your agency currently coordinates your agency's participation in the 

Global Health Security Agenda (GHSA) and with which individual and office at NSC 

does your agency coordinate with on matters related to the GHSA? 

In partnership with U.S. government agencies, other nations, international organizations, 

public and private stal<eholders, CDC seeks to accelerate progress toward a world safe 

and secure from infectious disease threats. CDC has a number of staff across programs 

that work on GHSA. Within the Center for Global Health (CGH), the Associate Director 

for Global Health Security coordinates with subject matter and technical experts 

throughout the agency to implement GHSA. It is the role of the Associate Director for 

Global Health Security to coordinate both efforts within CGH and across the agency. The 

Associate Director for Global Health Security also coordinates CDC cooperation with the 

Weapons of Mass Destruction & Biodefense office within the NSC. 

4. What efforts, if any, do you cooperate or collaborate with the Global Development Lab at 

USAID on? 

CDC currently does not collaborate with USAID's Global Development Lab.