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DRUG-RESISTANT TUBERCULOSIS:

THE NEXT GLOBAL HEALTH CRISIS?

BRIEFING AND 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 FOURTEENTH CONGRESS

FIRST SESSION

DECEMBER 8, 2015

Serial No. 114–171

Printed for the use of the Committee on Foreign Affairs

(

Available via the World Wide Web: http://www.foreignaffairs.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 

MATT SALMON, Arizona 

DARRELL E. ISSA, California 

TOM MARINO, Pennsylvania 

JEFF DUNCAN, South Carolina 

MO BROOKS, Alabama 

PAUL COOK, California 

RANDY K. WEBER SR., Texas 

SCOTT PERRY, Pennsylvania 

RON DESANTIS, Florida 

MARK MEADOWS, North Carolina 

TED S. YOHO, Florida 

CURT CLAWSON, Florida 

SCOTT DESJARLAIS, Tennessee 

REID J. RIBBLE, Wisconsin 

DAVID A. TROTT, Michigan 

LEE M. ZELDIN, New York 

DANIEL DONOVAN, New York 

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 

BRIAN HIGGINS, New York 

KAREN BASS, California 

WILLIAM KEATING, Massachusetts 

DAVID CICILLINE, Rhode Island 

ALAN GRAYSON, Florida 

AMI BERA, California 

ALAN S. LOWENTHAL, California 

GRACE MENG, New York 

LOIS FRANKEL, Florida 

TULSI GABBARD, Hawaii 

JOAQUIN CASTRO, Texas 

ROBIN L. KELLY, Illinois 

BRENDAN F. BOYLE, Pennsylvania

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 

CURT CLAWSON, Florida 

SCOTT DESJARLAIS, Tennessee 

DANIEL DONOVAN, New York 

KAREN BASS, California 

DAVID CICILLINE, Rhode Island 

AMI BERA, California 

(III)

C O N T E N T S 

Page

BRIEFER 

The Honorable Eric P. Goosby, M.D., Special Envoy on Tuberculosis, United 

Nations .................................................................................................................. 3

WITNESSES 

Tom Frieden, M.D., Director, Centers for Disease Control and Prevention ....... 19

The Honorable Ariel Pablos-Mendez, M.D., Assistant Administrator, Bureau 

for Global Health, U.S. Agency for International Development ....................... 30

LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE RECORD 

The Honorable Eric P. Goosby, M.D.: Prepared statement .................................. 7

Tom Frieden, M.D.: Prepared statement ............................................................... 22

The Honorable Ariel Pablos-Mendez, M.D.: Prepared statement ........................ 34

APPENDIX 

Briefing and hearing notice .................................................................................... 54

Briefing and hearing minutes ................................................................................. 55

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 American Thoracic Society ..................................................... 56

Statement of Aeras .............................................................................................. 60

(1)

DRUG-RESISTANT TUBERCULOSIS:

THE NEXT GLOBAL HEALTH CRISIS? 

TUESDAY, DECEMBER 8, 2015

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 2:01 p.m., in room 

2200 Rayburn House Office Building, Hon. Christopher H. Smith 

(chairman of the subcommittee) presiding. 

Mr. SMITH. Our briefing and hearing today is extremely urgent, 

focused on addressing what may very well be the next global health 

crisis: drug-resistant tuberculosis. 

Just as Ebola surprised many at the ferocity with which it 

spread, all of us must be concerned that the world is not currently 

prepared to meet the threat from this highly contagious airborne 

disease which killed 11⁄2 million people last year and that translates to about 4,000 people a day—4,000 lives that ended prematurely including many young children. 

The World Health Organization released its global tuberculosis 

report just over a month ago and appealed to the world to beef up 

efforts to combat TB, and yesterday in Cape Town, South Africa 

the International Union Against Tuberculosis and Lung Disease 

concluded its annual meeting as they gathered experts in fighting 

TB through all of the world. 

There are positive signs showing—these are positive signs showing that the global community continuous to surge toward ending 

TB by 2035 or sooner. 

While most TB is curable if diagnosed patients strictly adhere to 

a treatment regimen, some 6 million new cases of TB were reported 

to the WHO in 2014. 

However, it is likely the number is far higher. Some put it at approximately 9.6 million people. These individuals need to be diagnosed with a diagnostic that is fast and reliable and able to detect 

drug resistance and treated so that they can lead healthy and productive lives. 

On a myriad of the fronts there is reason for hope. For example, 

the Xpert MTB/RIF can diagnose TB and resistance to rifampicin 

within 2 hours and Dr. Frieden, in his testimony, elaborates on 

that—which is an amazing breakthrough. 

2

As Dr. Frieden will testify today, this new diagnostic holds great 

promise, enabling rapid detection of drug resistance and the U.S. 

Government has led the global effort to scale up access to this test. 

The increase in the proportion of drug-resistant TB cases diagnosed and started on treatment over the past several years is 

largely attributable to this kind of test. 

Yet, the tragic fact remains that some 480,000 new cases—of 

hard to treat cases of multi-drug resistant TB, a disease which 

often—far too often—hits the poorest of the poor—are estimated to 

have occurred in 2014. 

Yet, only about 25 percent of those cases, or 123,000 individuals, 

were detected and reported, leaving a whopping 75 percent undetected and untreated. 

Given the means at which TB can spread through the air, especially through coughing, and the fact that people with weakened 

immune systems are more susceptible, one can see how left untreated MDR–TB and its even more pernicious cousin, XDR—or extensively drug-resistant TB—can be absolutely catastrophic to individuals and wreak havoc on public health and public health systems. 

To illustrate how fragile health systems can be overrun, a course 

of treatment for normal drug-susceptible TB costs, roughly, between $100 and $500, depending on the country. For MDR–TB, the 

cost is roughly $5,000 to $100,000 and some put the numbers at 

far, far higher than that. To respond fully to the TB crisis, WHO estimates that some $8 

billion per year is needed. Unfortunately, there is a global budget 

shortfall of about $1.4 billion. 

We need to lead not only in terms of providing funding but also 

in terms of encouraging others—other countries but also the private sector and foundations in meeting this need by closing that 

gap. 

Now is the time for a significantly enhanced response to build on 

the tremendous work that people like Dr. Goosby and others have 

been doing. 

A sustained focus on tuberculosis prevention today will save lives 

and many tomorrow, helping people the world over as well as protecting their homelands from what otherwise could be a global pandemic. 

Our briefer and two witnesses today are extraordinary leaders in 

the health field and experts on TB. They, like many others on the 

subcommittee, believe we can at least mitigate TB in the short 

term and eliminate this deadly infectious disease by 2035, just as 

the global community successfully fought polio and other debilitating and deadly diseases. 

It takes political will, however, and an investment of resources 

that will pay dividends for healthier people in the long run. 

The subcommittee will continue to work hard in combating TB 

along with members of the House Tuberculosis Elimination Caucus, whose co-chair, Eliot Engel, will be here shortly to join us. I 

would like to now yield to Dr. Bera for any comments he might 

have. 

Mr. BERA. Thank you, Mr. Chairman, and thanks for convening 

this briefing and hearing and I want to thank the witnesses as 

3

well—a great panel. I will keep my comments short so we can hear 

from the witnesses. 

But as a physician and public health expert, the scourge of tuberculosis is one that we constantly have to be vigilant on and, certainly, I do worry that we are falling behind, given our arsenal and 

what medications we have and, certainly, having multi-drug resistant tuberculosis emerging and extremely multi-drug resistant tuberculosis is a global challenge. 

It is not just limited to developing countries. As we think about 

the interconnected nature of the world, we clearly have to be concerned about it, combating extremely drug-resistant tuberculosis in 

the countries where it is starting to become endemic but then also 

knowing that we have got to invest the money and the dollars in 

research and coming up with those next therapies and so forth and 

I think we are falling behind there. 

So with that, I am excited about the topic and look forward to 

hearing from the witnesses. 

Mr. SMITH. Thank you, Dr. Bera. 

I would like to now introduce our briefer, Dr. Eric Goosby, who 

currently serves as U.N. Special Envoy on Tuberculosis, a position 

he was appointed to in January by Secretary General Ban Kimoon. 

In this capacity as Special Envoy, Dr. Goosby works toward raising the profile in the fight against TB and promoting the adoption, 

financing and implementation of the World Health Organization’s 

global End TB Strategy while pursuing tuberculosis 2015 targets 

described in the Millennium Development Goals, which soon will be 

supplanted by the post-2015 goals, beginning January 1st. 

He previously served 4 years in U.S. State Department as Ambassador-at-Large and U.S. Global AIDS Coordinator and is no 

stranger to this subcommittee. I want to thank him for his availability as well as his exemplary work over the years. 

But in that position he oversaw the implementation of the President’s Emergency Plan for AIDS Relief. Ambassador Goosby returned to the University of California, San Francisco where he is 

Professor of Medicine and Director of Global Health Delivery and 

Diplomacy, Global Health Sciences. 

Dr. Goosby, the floor is yours. 

STATEMENT OF THE HONORABLE ERIC P. GOOSBY, M.D., 

SPECIAL ENVOY ON TUBERCULOSIS, UNITED NATIONS 

Dr. GOOSBY. Well, thank you, Mr. Chairman, acting Ranking 

Member Bera. 

It is a privilege to be with you today at this important briefing 

and hearing on drug-resistant tuberculosis and its potential to turn 

into the next global health crisis. 

TB is now the number-one infectious disease killer in the world, 

surpassing HIV/AIDS, according to the latest World Health Organization report on TB. 

We have a visual here to help you understand that. In this case, 

being number one is not an achievement. There is no trophy for 

taking more lives than any other disease. 

4

As Chairman Smith said, 4,100 people a day die from TB. Of the 

estimated 9 million annual deaths from all infectious causes, 11⁄2

million are attributed to tuberculosis. 

That translates into one out of six deaths of all infectious diseases. An estimated 1 million children became ill with TB and 

140,000 children died in 2014. 

Today, we can prevent, treat, and cure tuberculosis. The world 

has joined together to set the goal to end TB by 2035. But we will 

not do so without radically changing the path we are on. 

At the current rate, reducing incidence by 11⁄2 percent per year, 

it will take nearly 200 years to achieve this goal. Putting in place 

universal health coverage for an essential set of healthcare interventions including TB diagnosis and treatment will be of great importance if we want to successfully combat TB and other infectious 

and noncommunicable diseases. 

The problem of TB is not evenly distributed around the world. 

Today, there are 22 high-burden countries that account for 83 percent of the cases. 

That said, the problem we have to come to discuss, namely, 

multi-drug resistant TB, varies dramatically by geography in terms 

of the concentration of cases and the severity of resistance. 

While major strides have been made in the effort to reduce the 

burden of TB, the emergence of drug-resistant organisms presents 

a major challenge to patients and doctors. 

Of the 480,000 cases of multi-drug resistant TB (MDR–TB) estimated to have occurred in 2014, only about a quarter of these, as 

the chairman said, were detected and reported. 

In addition, treatment success rates are very low at less than 50 

percent. Most cases come from previously treated TB patients who 

developed resistance but this year the WHO reported a 50-percent 

increase in the percentage of patients who contract the disease directly from infected individuals. 

Remember, this is as an airborne disease. Many countries that 

bear the largest burden of MDR–TB are important strategic partners to the United States. 

More than half of the global burden of MDR–TB is carried by the 

BRICS countries and other emerging economies. The Russian Federation and Ukraine have the highest proportions among all new 

MDR cases. 

India, China, and the Russian Federation consist of over 45 percent of all the globally estimated numbers of MDR cases. An estimated 9.7 percent of people with MDR–TB have XDR–TB and 

countries like India, Ukraine, and South Africa reported the highest number of XDR–TB cases. 

With our current drug regimens we only succeed in treating 20 

percent successfully of XDR patients. Chairman Smith rightly 

warned last month that we must not allow multi-drug resistance 

to develop further as the climb to successfully combatting TB becomes much steeper. 

Left unchecked, drug-resistant TB alone could account for one in 

four deaths from antibiotic infections by 2050. Drug-resistant TB 

services for addressing drug-resistant TB in the U.S. and abroad 

must be scaled up immediately. 

5

Serious detection and treatment gaps for drug-resistant TB re- main. Of the $13 billion in TB funding required in 2015, about twothirds are for the detection and treatment of drug-susceptible TB 

and one-third for MDR–TB treatment. 

Today, only $6 million is funded and recent plans indicate that 

greater funding is required for MDR–TB globally as well for the capacity-building for healthcare workers to provide high-quality care. 

We need to find new resources to not only prevent this disease 

from shattering lives but also invest in research that will enable 

us to save more lives. 

It is imperative that we focus our efforts on calling out the tragedy which often strikes the voiceless. Those who suffer do so in silence. We need to be their voice. 

We need to unleash the outrage. We need to accelerate the political backing and momentum to make the bold strides needed to 

drive down the epidemic. 

While the call is urgent, there are signs of hope. Death rates 

from tuberculosis have dropped by nearly one-half since 1990 and 

the MDG target calling for halting and reversing TB incidents by 

2015 has been achieved globally. 

I applaud these achievements. It took many governments worldwide that have large-scale and sustainable programs providing 

basic TB care in their primary health services, and many countries 

with high TB/HIV burdens are mounting a solid response to the 

joint epidemics with prevention and care being scaled up but not 

yet with full coverage. 

It is also critical to note that TB interventions are cost effective 

and save lives. TB is the most effective health, intervention bearing 

a $43 return for every $1 invested. 

I know firsthand the experience of having to tuberculosis. When 

I was a young doctor I was diagnosed with latent TB. I was fortunate. 

I was diagnosed, active disease was ruled out and treatment with 

INH for 6 months was initiated, which successfully rid my body of 

the disease. 

Unfortunately, as you know, this is not the case for everyone. 

Some people remain undiagnosed. Some find the regimen too difficult to follow, particularly in the developing world, too expensive 

for active TB, and others become resistant to the drugs they are 

using. 

It is these people who drive me to work on this issue just as I 

am sure they drive you. The world owes a great deal of thanks to 

Congress and to the Obama administration for making global 

health a priority. 

I want to personally thank the subcommittee for its efforts to 

provide generous resources in the fight against TB. But this fight 

must also be a shared responsibility among all partners. 

Last week at a global summit on TB in Cape Town, mentioned 

by the chairman, I challenged all of the global health players involved with TB to take a hard look at their resources and how they 

are being used. 

We need to better understand what is being spent on TB and 

match our funding against the unmet needs. By doing this, we not 

only can fill in the gaps, we can eliminate duplication and parallel 

6

systems and identify and engage synergies that ensure resources 

are truly additive. 

In other words, let us ensure that low-income and the most vulnerable communities worldwide are first, not last, in our efforts to 

fight TB. 

Let us also ensure that we are not pitting one disease against 

another. It does not do any good to rob Peter to pay Paul. We can’t 

save children from malaria and have them die from TB. 

We need investments across the board in global health. Investments bent the incidence curve on HIV. It was dramatic and we 

saw this, and we can do the same for tuberculosis. 

Mr. Chairman, I would like to leave you with a story. In last 

month’s Tampa Bay Times, Dr. Jennifer Furin, a senior lecturer at 

Harvard Medical School, wrote an op-ed about her firsthand experience in dealing with children with TB in Lesotho. 

She writes,

‘‘I cannot forget seeing an 8-year-old boy as he crawled across 

to play with his friends. Being on all fours was not part of the 

fun but his only means of mobility. An infection in his knees 

caused by multi-drug resistant TB left him unable to walk or 

to stand. Resilient in the face of his illness, he looked to the 

sky with a shy grin as the other children shouted, ‘Crab, crab, 

come and get us, crab.’ But the playful laughter was soon replaced by silence. The young boy was killed by MDR–TB, and 

his sister and mother are also ill with the disease now.’’

Sadly, this story is heard all too often. We can prevent, diagnose, 

and cure drug-sensitive TB. But MDR–TB increasingly presents a 

serious challenge. We can and must do better. 

I thank you for your time. 

[The prepared statement of Dr. Goosby follows:]

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Mr. SMITH. Dr. Goosby, thank you so much for your very powerful insights and, again, your tremendous leadership over the years. 

With regards to new drugs and new diagnostics, I would note 

that bedaquiline is new yet it has a high toxicity, particularly toward the liver. 

And my question is, what can be done to incentivize pharmaceuticals here and anywhere else in the world, particularly in Europe where there is a highly sophisticated pharmaceutical industry, 

given this explosion of cases? 

Are there many ideas in the pipeline or compounds that are 

being looked at? And secondly, in the diagnostics—the Xpert MTB/

RIF—I know that the U.S. Government, and Dr. Frieden speaks 

about this in his testimony—and is being exported but waiting 

weeks or months for a diagnosis could lead to more drug resistance 

and a false diagnosis because that might be missed, the resistance 

part. 

For instance, an example at your meeting you just had in South 

Africa, was there an emphasis on new drugs and diagnostics and 

getting some of these very important new initiatives out? 

Dr. GOOSBY. Well, Chairman, I think you really hit one of the 

sensitive areas in the response to global TB burden, having adequate drug treatment is critical. 

As we have said, you can diagnose and treat tuberculosis for 

drug-sensitive TB. Eighty-seven percent of the time, people who 

take these medications correctly are cured with that engagement. 

It requires a 6-month treatment course but it requires, to do it 

safely, that the person be in care, linked to a monitoring and delivery system that can monitor the effects of the drugs on especially 

the liver and kidney, and have been part of the problem in identifying, entering and retaining people effectively in care for the duration of the need. 

That has been aided by two new drugs that, again, require continued monitoring, that have been approved by our FDA for drug 

treatment for multi-drug and XDR resistance. 

Interestingly, they are also effective in drug-sensitive treatment 

but are being reserved for the multi-drug XDR moment. 

The ability to get people in delivery systems that can diagnose, 

resist an organism, and not inappropriately start drug-sensitive 

medications at the first initiation of treatment is the critical piece 

that must be focused on. 

The pressure to generate multi-drug resistant and XDR–TB 

comes out of individuals who take the medication inappropriately, 

go on and off of one or two of the drugs and put an environmental 

pressure on the organism to favor the resistant outbreak. 

That can be changed by better retention and better education 

continuously throughout their treatment period and the strategies 

for that have been identified but have not been brought to scale or 

sustained in the manner that is needed to prevent MDR/XDR development. 

The Gene Xpert is a remarkable thing. Tom will speak to this. 

It has allowed us not to have to grow and culture an organism that 

grows very slowly and takes up to 6 to 8 weeks for us to actually 

get it to grow out of culture so we can identify it and then identify 

12

whether or not it contains resistance to the effective microbactericidal drugs, INH and rifampin. 

The ability to do that with the Gene Xpert is in about 2 hours 

what had been 6 weeks routinely, plus the patient stays in front 

of you. You don’t have them go off, have to find them to bring them 

back, to interpret the results and initiate the appropriate treatment. 

So Gene Xpert is a sea change in our ability to minimize the 

pressures in the system that favored the development of resistance. 

Mr. SMITH. In terms of the sea change, how many diagnostic kits 

do you think can be supplied worldwide? What is the capability? 

Dr. GOOSBY. I think some of my colleagues may have an answer 

to that. They are at a fraction of what they are needed in any given 

country. 

Many of the U.S. systems—PEPFAR, the USAID systems on tuberculosis—have invested early on in the Gene Xpert machine to 

make their availability wider. But it is a fraction of what the total 

amount is. 

Mr. SMITH. And does it detect for other antibiotics as well or just 

the one? 

Dr. GOOSBY. It looks for resistance to rifampin, one of the bactericidal antibiotics, and in the new formulations it will look for 

INH, rifampin and they have formulations now, cassettes that are 

being set up to look for other forms of antibiotic resistance that 

would give you a diagnosis for multi-drug and XDR–TB. 

Mr. SMITH. You mentioned that more than half of the global burden of MDR–TB is borne by the BRICS countries and other emerging economies. You didn’t mention Brazil. Do you have some insights on Brazil? 

Dr. GOOSBY. Brazil is a country that is heavily burdened with 

the response to tuberculosis, again, something that is known but 

has not moved to scale yet in the country. 

They are struggling with the knowledge of how to diagnose and 

treat but not having it available to all of those in the population 

that need it. 

Their economic wobble that they are on now has created an interval in their ability to invest in it as a country and they are now 

in need of support globally to try to get over this period of economic 

decline. 

Mr. SMITH. Let me just ask you with regards to so many people 

with compromised immune systems which seems to be in ascendancy——

Dr. GOOSBY. Yes. 

Mr. SMITH [continuing]. My wife has an autoimmune disease and 

it seems it is—there are growing numbers of those cases, which 

makes, obviously, she and so many others more susceptible. 

Do you see—as Dr. Frieden points out, there—92, I think it was, 

was the point where we hit—you know, that we have gone down 

ever since here in the United States. 

If you could speak to this trend, it seems to be, of autoimmune 

diseases that are throughout the country, and secondly, the—if you 

could answer that and then I will do my final question and then 

go to Dr. Bera. 

Dr. GOOSBY. Sure. 

13

Well, Mr. Chairman, I think you are right to point out that the 

susceptibility to tuberculosis goes across a spectrum of diseases 

that engage or diminish your immune system’s ability to respond 

to an infectious agent, identify the organism and clear it. 

The identification often is not the difficult part but having the 

ability for your white cells and so-called cell-mediated response to 

come in and clear that organism from the body, to sterilize it, has 

been a big part of why individuals who are immunochallenged, 

immunocompromised like with HIV, those with collagen vascular 

diseases, those who have had chemotherapy, the third trimester of 

pregnancy, and just aging as your immune system wanes, increases 

your vulnerability to developing active disease with the same exposure. 

The defect in cell-mediated response is especially bad for those 

who are HIV positive. The susceptibility to gaining an active disease from the same exposure in an HIV-infected person has been 

estimated to be over 100 times that of the HIV negative individual 

and explains why tuberculosis remains the leading killer for HIVinfected people on the planet. 

Mr. SMITH. I have a question. Excuse me. 

Dr. GOOSBY. I was just going to say the ability to identify those 

aspects of the immune response that makes them susceptible to active TB is a critical target for research and our ability to understand this is well within our realm of our understanding of immunology. 

But we have not applied our immunologic tools to characterize 

the more subtle responses that individuals have when exposed to 

TB in their immune system. 

NIH is now primed, as is CDC, to take those studies through to 

completion because in many ways they follow the same path that 

was used to characterize the immunologic response description of 

the natural history pathophysiology for HIV. So those labs are set 

up and ready to turn to TB. 

Mr. SMITH. Last question. Since 2007, we, in the United States, 

as you know so well, have been doing very aggressive screening 

among the immigrant population—legal immigrants this is—and 

the refugees, the 450,000 immigrants and 70,000 refugees annually, and as a matter of fact, it is so stringent that if somebody has 

TB they have to come in without it or they are inadmissible to the 

United States. 

Seven weeks ago, I held a hearing on Syrian refugees and we 

had the regional representative for the UNHCR as one of our witnesses, Pitterman, who did a wonderful job and he talked about the 

fact that the gross underfunding of the refugees including the appeals—we have more people who are displaced—IDPs or genuine 

refugees—than ever before, and yet the appeals go out for the 

UNHCR and 41, 44, 43 percent comes back so we are underfunding 

it, and that the trigger for this mass exodus into Europe and someday to the United States was, frankly, the World Food Programme 

cut of 30 percent, which put a number of people to flight, thinking 

that they were hopeless. 

Huge migrations of people across borders. Many people are sick, 

compromised immunity, I would think, as a result. Since we are 

doing such robust screening on at least legal immigrants, what is 

14

the U.N. looking to do with all of these mass flows of individuals 

who could be carrying these horrific diseases, putting themselves, 

their families and then anyone else with whom they have come in 

contact with at risk of getting TB? 

Dr. GOOSBY. Well, Chairman, you bring a terrific point forward. 

Our colleagues in the European sector as this immigration occurs 

are scrambling to try to mount a humane and responsive screening 

mechanism that allows those individuals who are suffering from 

underlying diseases that can be diagnosed and treated, those that 

indeed may afford a risk to their new population that they are entering but also afford a risk to themselves and their families, need 

to be screened for, identified, diagnosed, and treated. 

Mr. SMITH. Are any countries doing that, particularly European 

countries, Germany, for example? Are they screening for TB? 

Dr. GOOSBY. They are doing it once people get to the country but 

are not doing it in a refugee status to the degree that they need 

to. They are at a very early stage in mounting that response. 

On the down side, they need to do more. On the up side is they 

realize that and are really working to gain a global awareness that 

results in, hopefully, investment by the global community in trying 

to put a screening capability in place. 

Mr. SMITH. Is there any preliminary data from, like, Germany or 

any of the other countries that suggest that——

Dr. GOOSBY. You know, I am not aware of any, Mr. Chairman, 

that I would be willing to give to you at this point. But I will look 

into that and come back to you with it. 

Mr. SMITH. Appreciate that. 

Dr. Bera. 

Mr. BERA. Thank you, Mr. Chairman, and again, thank you for 

your testimony, Dr. Goosby. 

As one of those young interns who started my residency negative 

on my skin tests and turned positive, I was grateful for that surveillance program. 

I was grateful that I was able to have the latent TB infection 

treated and it does talk about the importance of surveillance. 

In my public health career as chief medical officer to the programs that I directed for Sacramento County was the refugee 

screening program, which was exactly that. 

We have a large Eastern European refugee population in the 

Sacramento area. You would have rudimentary screening in their 

country of origin so we would certainly do much more robust 

screening on arrival and, obviously, tuberculosis was one of the entities that we were looking for. 

A second program that we treated, that we had under my jurisdiction, was the chest clinic, which was our TB surveillance program in Sacramento County. 

And as you have rightfully pointed out, a key component of treating tuberculosis is not just making the diagnosis of active TB, getting the patient on the right therapy, but then making sure, and 

our program was a directly observed therapy program where you 

were sending public health nurses out there on a regular basis, observing them take their medications, because that is the risk that 

we run—folks starting the medications, not completing therapy, 

and then we run into this issue of a limited arsenal. 

15

A couple questions. You talked about Gene Xpert and the ability 

to better sort out susceptibility and sensitivity to the arsenal. I 

may have missed it. I think Chairman Smith asked the cost of 

Gene Xpert. 

Dr. GOOSBY. So there were the research and development costs 

and then there was the initial kind of formulation of the machinery, all of that now being tucked and settled. 

The cartridge costs started at about $24 for each sputum examined to determine whether it was resistant, had microbacterium, 

and whether or not there was rifampin resistance. 

That now went down to $10 with investments from USAID and 

PEPFAR back in 2013 and now it is down to below $8 and with 

kind of unit price, scale-up will actually drop below that. 

Mr. BERA. And the actual machinery is of a size that you can 

have out in the field with you so if you were to take this to a refugee camp, let’s say. 

Dr. GOOSBY. It is of the size that you could take out in the field. 

It is the size of a small computer about this high down there, about 

that wide. 

The cartridges, you stick them into the machine and literally it 

won’t evaluate sputum only, but spit will be good enough because 

it is a PCR-generated test. 

So you don’t have to induce sputum like you do for a normal 

smear positivity and staining exercise and that advantage alone 

makes it hugely impactful. It can run on solar power and we have 

many examples of that and doesn’t require a cold chain to keep 

specimens and store specimens. 

There is also a whole technology trying to look at how to preserve specimens without a cold chain for days that will allow for 

a pooling and aggregation of specimens so you can run batches. 

All of that technology has been worked out but has not been 

brought to scale. 

Mr. BERA. So there is a urgency of getting this to scale and getting this out to the field as quick as possible. If we think about the 

11⁄2 million cases of tuberculosis, what percentage would you say 

are INH- and rifampin-sensitive versus not sensitive? 

Dr. GOOSBY. So of the initial cases of tuberculosis, less than 3 

percent actually are carrying MDR in the whole pool of TB and of 

the 3 percent that develop MDR about 10 percent of those cases 

can develop XDR–TB. 

Mr. BERA. Well, again, if we are thinking about a global strategy 

here, it is incredibly important that we don’t overuse our arsenal. 

Dr. GOOSBY. Yes. 

Mr. BERA [continuing]. Our superantibiotics here and that we actually—again, if what you are saying is 97 percent are still sensitive to INH and rifampin, the danger we run into is that we just 

treat everything with our most effective medications and then we 

start losing those. 

And so the starting point is really getting to scale, getting this 

Gene Xpert out there into the field and recognizing that, you know, 

here is the 97 percent of folks that we can treat with our usual 

medications so we just save our latest medications for those that 

are multi-drug resistant or extremely multi-drug resistant. 

16

We have seen what has happened in general as antibiotic use 

over time where we go to the next latest and greatest antibiotic 

therapy and we start to develop this drug resistance whereas we 

have got to be vigilant so, certainly, is where investing in those 

next therapies and so forth. 

We still got a good arsenal in INH and rifampin. Doesn’t mean 

we shouldn’t be investing in the next generation and the next arsenal and staying ahead of this but we should make sure we are 

using the appropriate medications. 

Dr. GOOSBY. Your background speaks to your wisdom with that. 

You are absolutely right. 

Part of our task is to be excellent in making the diagnosis and 

identifying those who are carrying a resistant organism and then 

putting them on the appropriate medication, not inappropriately or 

unnecessarily using the medication that we want to reserve for 

those who, indeed, hold a resistant organism. 

I think that your time in Sacramento showed you how easy and 

with all the well meaning in the world you can do that and I believe that the widely available ability to diagnose MDR or XDR–

TB will preempt that evolution. 

Right now, we have a moment to prevent that evolution from 

going is your point. I completely agree with you, and the urgent 

need for drugs in the pipeline and for other diagnostics to continue 

to be on the working table is also evident to all of us who have 

done this a long time and that we see how fragilely we are standing on a precipice that we could go over and never be able to recover from. 

Mr. BERA. Chairman Smith alluded to the fact that we have gotten ahead of this in the United States. But would you articulate 

why folks here domestically have to be concerned with, you know, 

the emergence and escalation of TB around the world? 

Dr. GOOSBY. Well, I think the next two speakers are expert in 

this threat. Our ability to move people in hours from one area of 

the world to another is well established—airplanes—and an airborne disease such as tuberculosis is in its ability to spread affords 

a real threat in that regard. 

It is shortsighted to think that we need to wait until a person, 

a patient, comes in from a foreign life where TB is endemic and 

they are infected and then manifest with symptoms here in this 

country. 

We have to be vigilant but compassionate in our ability to identify, enter and retain these patients and people in care and services. 

Our country has open arms in the immigration sense. This is a 

threat that makes us question if we are doing this correctly. But 

we are smart enough to figure out how to do it safely. 

Mr. BERA. Great. And, again, just for the domestic audience, 

while we may think of tuberculosis as a disease that infects lowerincome immigrant populations, et cetera, what we know, since it is 

an airborne disease, having done some of these epidemiologic surveys, when you get these outbreaks it is not limited to those populations. 

It spreads, and it is much better to prevent and get ahead of this. 

It can affect anyone. 

17

Dr. GOOSBY. Absolutely right. Absolutely right. 

Mr. BERA. Well, thank you for being here. 

Mr. SMITH. Mr. Engel. 

Mr. ENGEL. Thank you. Okay. That is better. 

Thank you. Thank you, Mr. Chairman, and I also want to thank 

our ranking member, Congresswoman Bass, and our witnesses for 

appearing here today. 

I am the ranking member of the entire committee of the House 

Committee on Foreign Affairs but also have done a lot of work on 

the fight against tuberculosis. It has been a priority for me for a 

long time. 

So many people around the world needlessly suffer from this disease and investing in diagnosis and treatment helps build healthier 

communities in the developing world, something I tried to achieve 

through the Stop TB Now Act, much of which became law in 2008. 

We know that healthier communities are stronger and more 

prosperous, so for me this is a foreign policy priority as well as a 

global health priority. 

We like to think of tuberculosis as a disease quickly becoming 

part of the past and, after all, we have made wonderful strides in 

the fight against TB. But between 2000 and 2014, effective diagnosis and treatment accounted for 43 million lives saved. That is 

great. 

Since I came to Congress nearly 27 years ago, the worldwide TB 

death rate has dropped by nearly 50 percent and here in the U.S., 

the number of annual deaths due to TB has dropped by two-thirds 

just since 1992. 

And we know how to diagnose this disease. We know how to cure 

it. So in some ways we seem to be headed in the right direction 

when it comes to wiping out tuberculosis. 

But the reality, however, is that TB has become the number one 

infectious killer worldwide. One and a half million people, including 140,000 children, died from TB last year, and during that same 

period, nearly 10 million people became infected with the disease, 

and nearly 1⁄2 million developed multi-drug resistant TB, and we 

know people fighting HIV/AIDS also are very prone to getting TB 

as well. 

So while we have made real progress fighting tuberculosis, we 

need to stay focused and finish the job. So I thank you, Doctor, for 

all the good work that you do. 

Obviously, we need to be clear-eyed about the challenge that remains, set ambitious goals and do what it takes to reach these 

aims. For example, I am glad that the U.N. included the fight 

against TB in its sustainable development goals. 

Ending the global TB epidemic by 2030 won’t be easy but it is 

a good first step that the U.N. is prioritizing this effort. And let me 

just say finally as the co-chair of the TB Elimination Caucus, I will 

continue talking about this issue and pushing for robust investment in TB research and treatment. 

I am pleased that this subcommittee is taking the time to examine this problem. I look forward to a good discussion. I thank you 

for your partnership. 

Doctor, thank you and all the other people, even in the audience, 

who have worked so hard and made this a priority in their lives. 

18

I yield back. Thank you for giving me the opportunity today. 

Mr. SMITH. Thank you very much, Ranking Member Engel, and 

another example where there is just close bipartisanship, cooperation and support, the way it ought to be, and I want to thank my 

good friend for his leadership for these many, many years. 

I would like to ask you just finally, and maybe you can get back 

to us on this, but as you come across members of Parliament, executive branch members that you think we might liaison with and 

talk to and try to get a stronger concerted effort, please let us 

know. 

I chair the delegation to the Organization for Security and Cooperation in Europe Parliamentary Assembly. I work on trafficking 

and a whole host of issues, and I often find when you bring up an 

issue like this they say oh, Joe or Jim or Mary, they work on this 

too—you ought to talk to them. 

And since you are in contact with them all the time it would be 

an open door invitation for us to work with like-minded parliamentarians. 

Thank you again. 

Dr. GOOSBY. It was a pleasure, Chairman. Thank you so much. 

Mr. SMITH. Thank you, Dr. Goosby. 

The briefing now comes to an end and pursuant to notice now 

call to order the hearing. Let me now invite to the witness table 

our second panel, beginning with Dr. Tom Frieden, who has been 

the Director of the Centers for Disease Control and Prevention 

since June 2009 and has dedicated his career to fighting infectious 

and chronic diseases both here in the United States and abroad. 

He led New York City’s program that controlled tuberculosis and 

reduced multi-drug resistant cases by 80 percent. He worked in 

India as well for 5 years helping to build a tuberculosis control program that has saved nearly 3 million lives. 

As the commissioner of New York City’s Health Department Dr. 

Frieden led programs that reduced illness and death and increased 

life expectancy substantially. 

He is a recipient of numerous awards and honors, has published 

more than 200 scientific articles, has previously testified before this 

subcommittee and we welcome him back. 

And then we will go to the Honorable Ariel Pablos-Mendez, who 

is the Assistant Administrator for Global Health in USAID, a position he assumed in August 2011. 

Dr. Pablos-Mendez joined USAID’s leadership team with a vision 

to shape the Bureau for Global Health’s efforts to accomplish a 

measurable and sustainable impact on the lives of people in developing countries, and he has been doing that and doing it extremely 

well. 

Prior to joining USAID, he worked on global health strategy and 

the transformation of health systems in Africa and Asia. 

He has also served as the Director of Knowledge Management at 

the World Health Organization. Dr. Pablos-Mendez is a board-certified internist and until recently was a professor of clinical medicine and epidemiology at Columbia University. 

Dr. Frieden, the floor is yours. 

19

STATEMENT OF TOM FRIEDEN, M.D., DIRECTOR, CENTERS 

FOR DISEASE CONTROL AND PREVENTION 

Dr. FRIEDEN. Thank you very much, Chairman Smith and Congressman Engel, for your interest and leadership addressing this 

and other critically important global health issues. 

I am here as CDC Director but I have spent much of my career 

working on the issue of tuberculosis and support for tuberculosis 

patients. I would like to tell you about one of them. 

In the early 1990s, while I was working as an epidemic intelligence service officer and then director of the Bureau of Tuberculosis Control program in New York City, I treated a young man 

from Kerala, India. 

He had what we would now call extensively drug-resistant tuberculosis, or XDR–TB. I treated him for close to 2 years. He required 

the resection of part of his lung, experimental treatment, and treatment with injectable antibiotics, which his wife, fortunately a 

nurse, was able to provide for him for a period of well over 18 

months. 

Fortunately, he was able to be cured of his disease. At that time 

many years ago it cost over $100,000 for his care. Years later, 

while working on secondment from CDC to the World Health Organization in India, I was able to go to his home village in Kerala 

where we were able to establish a program that would have prevented his case of multi-drug resistant tuberculosis for $10. 

In New York City, we documented the largest outbreak of multidrug resistant tuberculosis to have ever occurred in this country 

and we also documented its very rapid control, and that brings me 

to the three key points I would like to make about tuberculosis. 

First, it is a big problem, second, we can stop it, and third, the 

CDC plays a pivotal role in that global effort. It is a big problem, 

as you know. Last year, 11⁄2 million people died from a disease that 

is virtually 100 percent curable. 

In addition, we are seeing increase in drug-resistant strains of 

the organism and this is a reflection not only of a failure of effective programs but also of a failure of a investment and coordination. 

Tuberculosis affects society and increases poverty. It is also a reflection of challenges that countries have to support patients and 

effective health systems. 

If you look at the countries where tuberculosis is spreading most 

widely, they have the combination of poverty, HIV, in some cases 

a government system that is not providing as effective care as it 

can, in some cases a private healthcare system that is providing 

chaotic and irrational treatments for tuberculosis. 

And as a result of that, you are seeing lots of spread in communities in the healthcare systems. And one thing to really emphasize 

is the risk of spread within healthcare facilities. 

Both Dr. Bera and Dr. Goosby commented on having become infected with tuberculosis during their training. I have too, I mentioned that I am a member of that club as well, having become infected working in a tuberculosis clinic in New York City. Again, 

preventive treatment has greatly reduced my risk of ever developing the disease in the future. 

20

But that is just an example of what happens. Around the world, 

people with HIV get infected in hospitals and go on to develop disease. 

In New York City in the early 1990s, we were able to show with 

one of the first molecular epidemiological studies ever done of tuberculosis that a large proportion of cases—in fact, perhaps even 

more than half of all of the multi-drug resistant cases in New York 

City at that time, were picked up in the hospital. 

So the first point is it is a big problem. The second point is that 

we can stop TB. We need political will. We need to build on momentum. We need investment. We need commitments that are 

matched by resources, both from within countries multilaterally 

and bilaterally. 

We also have better diagnostics now and as I, and as you mentioned, Mr. Chairman, we have gone from 2 months to 2 days to 

the diagnosis of multi-drug resistant tuberculosis and there are 

many different technologies. 

Gene Xpert is one very strong one that is being used for TB and 

other pathogens. There are others as well and there will be others 

coming down the pike. 

In the U.S., we are using forms of sequencing large parts of the 

TB genome to be able to get resistance testing to first- and secondline drugs, at least on a preliminary basis, in real-time throughout 

the U.S. and that has been a very successful pilot. 

We also need to improve the treatment and the treatment of patients as the VIP of the program. TB patients all over the world 

don’t get the services they need to complete treatment and that is 

not just bad for them and their families. 

That is bad for all of us. That is why the TB patient has to be 

the VIP of the program and effectively manage programs to treat 

them as such. 

We also need to ensure that there is effective supervision and the 

core technical excellence continues. We continue to hear all too 

often about medications not being available, diagnostics not being 

available, patients not being supported through the course of their 

treatment. 

And, of course, we need continuous innovation. We have the tools 

we have today because of innovations. We will have better tools if 

we continue to innovate. 

At CDC within this country we coordinate a network of experts 

in the treatment of multi-drug resistant tuberculosis with extensive 

experience. This includes physicians, laboratory workers, public 

health outreach workers, public health nurses, implementation experts, and others. 

We have a very successful program, as you mentioned, Mr. 

Chairman, on refugee and immigrant screening. It is really a triple 

win. 

What we have done is to strengthen the diagnostic and treatment capacity in countries all over the world. That means that not 

just for immigrants and refugees but for other people in those 

countries there is the better opportunity to be accurately diagnosed 

and effectively treated. 

It is a win for these individuals because they are more likely to 

be cured and it is a win for the U.S. because we have been able 

21

to treat just over the last 2 years close to 3,000 patients around 

the world who didn’t come here with tuberculosis. This is a very 

successful and cost-effective program. 

We also have at CDC unique expertise in areas such as infection 

control where we are hoping to reduce the risk that people will pick 

up tuberculosis in clinics and hospitals all around the world and 

a unique opportunity to advance research. 

We have been in our laboratory validating and extending and 

creating some new tools for diagnostics. Some of the drugs that are 

currently being used were first studied in our own laboratory and, 

of course, we all hope that at some point in the future there will 

be a vaccine for tuberculosis, although at present we have nothing 

to offer beyond a vaccine that protects children against some forms 

of TB. 

Also, with support from Congress we are expanding the Global 

Health Security Agenda and in this regard expanding programs to 

track and stop drug-resistant bacteria, including tuberculosis. 

And, of course, the PEPFAR program, which Dr. Goosby ran for 

many years, is critically important in providing treatment for HIV, 

which will reduce the rate of TB, and for TB, which is the most 

deadly opportunistic infection among people living with HIV, killing nearly one-third of the people with HIV who die each year. 

In conclusion, there is one core fact I would like us always to remember about multi-drug resistant tuberculosis and drug-resistant 

tuberculosis in general, and it is this: No program can treat drugresistant tuberculosis faster than a poorly organized program can 

spread and create drug-resistant tuberculosis. 

Therefore, it is essential that we focus on the core aspects of providing high-quality diagnosis and treatment to all patients with tuberculosis, those susceptible to tuberculosis, and those with drugresistant tuberculosis. 

TB is nearly 100 percent curable, but the biggest challenge to tuberculosis control and prevention and elimination efforts is the 

challenge of persistence—that individual patients, when their 

symptoms resolve, programs when it is no longer on the headlines, 

physicians when they are no longer thinking of it, will not sustain 

the programs needed to sustain the progress which we can achieve 

to stop tuberculosis. 

And we look forward at CDC to continuing to work with Congress, with our agency partners from throughput the U.S. Government, and with partners from affected countries and around the 

world to accelerate the cure and eventual elimination of tuberculosis. 

Thank you. 

[The prepared statement of Dr. Frieden follows:]

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

Dr. Pablos-Mendez. 

STATEMENT OF THE HONORABLE ARIEL PABLOS-MENDEZ, 

M.D., ASSISTANT ADMINISTRATOR, BUREAU FOR GLOBAL 

HEALTH, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT 

Dr. PABLOS-MENDEZ. Thank you very much, Chairman Smith, 

Congressman Bera, and Engel, my own Representative. 

Thank you for being champions for global health for tuberculosis 

and for allowing us into this room to testify on our work in tuberculosis and MDR–TB work that USAID has been doing for many, 

many years. 

I also want to thank Dr. Eric Goosby for his leadership and passionate comments. I guess all the four doctors in the room with Dr. 

Bera have been infected with tuberculosis so we all have personal 

experience. 

But also we go back a long way. When I was training in New 

York in the 1980s, we began to notice MDR–TB among the homeless, and it was through tuberculosis that I think many of us got 

into the global health space. 

I worked with Tom Frieden turning the tide of what at the time 

was a big outbreak of MDR–TB accelerated by HIV. 

You will recall that people have forgotten tuberculosis in the 

United States by the 1980s and now we had an incredible flare. We 

did turn the tide in New York and we feel confident we can also 

beat the disease globally. 

Since that situation in New York, the World Health Organization 

declared a global emergency and a lot of effort has been going on 

in the international community that we didn’t have in the 1980s. 

So the 1990s began to have a transformation. 

The U.S. Government stepped up to the plate; all of the agencies 

began to work. In the last 20 years, plenty has been happening. 

Plenty has been accomplished. 

I was in 1997, I went to WHO for the first time where we produced the first global report on MDR–TB. I came to testify on what 

was the first piece of evidence on MDR–TB around the world. We 

showed a big, big problem, of course, in Eastern Europe, hot spots 

also in other parts of the world. 

When I joined the Rockefeller Foundation, I was very engaged in 

public-private partnerships, working with the NIH and the pharmaceutical companies to create a new partnership, the Global Alliance for TB Drug Development, to begin the development of new 

drugs. 

None had been developed over 50 years and we needed new 

drugs to fight the disease, not only to have new drugs against 

MDR–TB but also to shorten—to make the treatment of tuberculosis shorter and simpler, because as Tom has stated, if we can 

control TB in the right way we can prevent the emergence and 

spread of MDR–TB. 

We also worked together in the year 2000, a pivotal year for global TB control, in the establishment of the Global TB Drug Facility 

which the U.S. Government supported. 

USAID supported the first global surveillance report and since 

has supported the Alliance for TB Drug Development, has supVerDate 0ct 09 2002 13:40 Jul 28, 2016 Jkt 000000 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 F:\WORK\_AGH\120815\97856 SHIRL
31

ported now the Global TB Drug Facility, which is a platform that 

allow us to procure prequalified drugs and make it available to expand international TB programs around the world. 

A lot has been done. I am very proud of the work of the USAID 

and the U.S. Government, but we need to do more and in new 

ways, no doubt. 

The problem that we are addressing—MDR–TB—is a big, big 

challenge. Tuberculosis is now, as you heard, the leading infectious 

killer in the world and I think that that is a very important signal. 

This year’s report is an important piece of evidence that will help 

us rally attention and support in the fight against tuberculosis. 

In those 20 years where, thanks to your support, the commitments of the U.S. Government have increased. We started with 

about $10 million 20 years ago to fight tuberculosis. 

We now, of course, have far more than that. That period of time, 

in that 20 years, tuberculosis was growing and then was stopped 

and has begun to decline at a 10-percent decline in the incidence 

of tuberculosis worldwide. 

Tuberculosis mortality, as we heard from the introductory commentary, has been nearly halved in these 20 years. So about 43 

million lives have been saved by treating tuberculosis—quite an 

impressive accomplishment in these 20 years—and there is no 

doubt the U.S. Government in particular to all of our agencies and 

USAID, as the lead international agency for TB control, has been 

truly the champions in this campaign. 

We think we are doing okay, but not on MDR–TB. We need to 

do a lot more. We have put together the U.S. Government across 

the agencies a new strategy for the U.S. Government Global TB 

strategy, which aims to reach, cure, and prevent tuberculosis. 

As we know, there are many patients who cannot, at present, be 

detected and we have to decrease that; our goals by 2019 are to reduce the incidence further by 25 percent, maintain the success rate 

of those patients who are now being detected at 90 percent, successfully treat 13 million patients directly by our efforts, and initiate the treatment of 360,000 MDR–TB patients as well as reaching all of the people who have HIV and TB with antiretroviral 

treatment. 

Our work is focused in about 54 countries but we also extend the 

reach of the U.S. Government commitment through the Global 

Fund, which reaches about 100 countries, providing more focused 

technical assistance to ensure that those resources are matched by 

others in the fight against tuberculosis. 

MDR–TB itself is, of course, the big challenge and we heard before about the Xpert DNA testing system. It has been really a 

transformation in this decade and it is the fruit of research, the 

fruit of the cooperation with the private sector. 

In the year 2011, there were about 1⁄2 million cartridges distributed around the world; in the last year, 5 million, so a tenfold increase in the spread of the Xpert system reached around the world. 

Quite significant, not only for the MDR–TB detection and treatment, but also for the regular TB among children that have more 

difficulty in being diagnosed with the traditional methodologies. 

Likewise, just since 2010 the treatment of MDR–TB has been tripled. There were about 20,000 patients put on MDR–TB treatment 

32

in the year 2010. Now we have tripled that and with the Global 

Fund we are doubling that. Still, it is not enough. 

We have many more patients that we need to diagnose and treat. 

But it gives you a sense of the great progress that we have had recently thanks, again, to the bipartisan support of Congress and the 

work of the interagency in the United States but also working with 

many partners. 

Our work is, clearly, leveraging the World Health Organization 

guidance to countries and the countries’ own ability to pay for tuberculosis control. 

Scaling up the treatment of MDR–TB will require more resources 

than we have at the moment. There is no doubt about that. But 

it also requires better ways to do what we do with the resources 

we do have. 

We have been working on investing in new diagnosis and new 

drugs, and new drugs are finally coming online though they are not 

great yet. 

Indeed, we are working with bedaquiline, for example—a drug 

Congressman Smith noted is, indeed, not a perfect drug it is a drug 

that has been approved by the FDA, the first such approved TB 

drug in 50 years, and is part of the development of new drugs coming in the pipeline. 

We are working on bedaquiline with Johnson & Johnson and 

Janssen Pharmaceuticals to begin to introduce. More than 4,000 

patients have now been treated. We are learning. We are following 

the research guidance carefully to learn further as we expand donation programs and others. 

It is a new drug. We have to be careful. We don’t want to lose 

it. As Congressman Bera said, we have to be careful with those 

drugs both in monitoring and toxicity. 

There are two things that many of the drugs we use today in tuberculosis had they gone through the FDA approval today may not 

have gone through. But they have been quite successful over the 

last 50 years and we have to still do better in this regard. 

And as I said, MDR–TB will be important. We have been working and I am very proud of the work the team has been doing. As 

someone who has been quite involved in drugs for tuberculosis—

the development, purchasing, and so on—there have been clever 

ways to work with the manufacturers because we need to have 

drugs. 

And I remember in New York, Tom, that the manufacturers were 

not there. So working with the manufacturers to ensure that we 

have prequalified MDR–TB drugs has been very important. There 

were not many in 1993. 

We have been working with many of them. Now we have over 30 

manufacturers capable of producing the drugs that we are using 

and also working with them and exchanging technical assistance 

for price reductions that have led to a 50-percent reduction in the 

cost of MDR–TB regimes in the last 10 years. 

We need to do more. We need to do better. USAID is also working on the cutting edge of research. The NIH invests significantly. 

It is the leading organization investing in research for the U.S. 

Government and we are working on the implementation side in the 

later phases of randomized clinical trials, working also on how we 

33

implement and expand treatment and diagnosis, and working to 

support most of the guidance that the WHO has put out have been 

the result of the support that we are doing, working with them 

technically and financially. 

We are in the midst now of the STREAM clinical trial, which is 

the first randomized clinical trial of MDR–TB long term. We have 

been doing lots of pieces of that but this is going to be a very significant effort for us going forward. However, we agree we need to 

do more. 

I think that the cost of TB control will run from $8 billion cited 

by Chairman Smith to about $13 billion by 2030 and so we need 

to almost double the commitments that we have today. 

But most of the high-burden countries in tuberculosis pay for 80 

percent of the cost. So we have been quite focused. We are working 

on domestic resource mobilization. 

We want to make sure those governments supplement the taxpayers’ money that we are bringing in with technical assistance 

with international partnerships and so on for them to take more 

ownership of that and they are doing very well. 

I think South Africa, with the Xpert system for diagnosis, has 

been a great example—India doubling their budgets for TB control, 

many others—like Indonesia, where we have been working to expand a nationwide MDR–TB diagnostic and treatment. So, clearly, 

we need to continue to do that. 

In conclusion, tuberculosis has been around for awhile. We have 

done a lot of good work recently but it is now the leading infectious 

killer in the world. 

And MDR–TB is like Ebola with wings. Indeed, it is something 

that can be as easy to acquire in a way as Ebola—as a percentage 

over time—and has equivalent mortality untreated and it can be 

transmitted—it is airborne. So we are—you are right to be calling 

this attention to this important program. 

The U.S. Government, the USAID efforts in the fight will be 

maintained with the strategy that we have right now for 2019 as 

well as a part of the global effort for TB. 

I think, importantly, we have stopped TB from growing. It is now 

declining. We need to do the same thing with MDR–TB. We can do 

it. 

Thank you. 

[The prepared statement of Dr. Pablos-Mendez follows:]

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Mr. SMITH. Thank you so very much, Doctor. 

Just let me begin the questioning. In talking about the 

diagnostics, if you are talking about Lyme disease or any other disease out there, the response is only as good as the diagnostics. 

And so the Gene Xpert that has been talked about by all of you: 

How much does it cost, who manufactures it, and are orders coming in or requests coming in all over the world for it, to put it into 

this healthcare setting or that? 

And what kind of infrastructure does that require? Is it adaptable to a very rural situation in a developing country? 

Dr. FRIEDEN. Maybe I will start and then Dr. Pablos-Mendez will 

continue. 

As you point out, Chairman Smith, the key is a laboratory network. A laboratory network includes a national lab. That might be 

a reference lab, sometimes a supranational lab. 

At CDC, we have been able to support, for example, the African 

Society for Laboratory Medicine, which has strengthened laboratory systems in dozens of countries around Africa. 

And then within countries, you need to have the diagnosis at the 

point of care or diagnosis at an intermediate level and then at referral levels. 

Different tests are appropriate and effective for different levels of 

the healthcare system. We don’t yet have the ideal test for tuberculosis. 

Today in west Africa we are using point of care tests for Ebola 

that give us a preliminary result in 20 minutes. We don’t have that 

for TB. 

But the Gene Xpert is a major advance as are other rapid molecular diagnostic tools which allow us to get in a few hours at least 

a preliminary result or, in the case of Gene Xpert, a definitive result about the presence of resistance mutations or the presence of 

tuberculosis bacteria. 

There are some requirements, some of them more fixed than others in terms of refrigeration and electrical supply, and I would emphasize that it doesn’t replace the need to have and strengthen 

core diagnostic systems including microscopy, sputum collection, 

sputum referral, specimen transport, and follow-up. 

But it is a very important new tool that has allowed us to greatly 

increase the diagnosis of drug-resistant TB which is a preliminary 

step to improving the treatment of drug-resistant TB. 

Dr. PABLOS-MENDEZ. Thank you. 

Indeed, I think the laboratory structure Tom alluded to and as 

we spoke of, the overall surveillance of MDR–TB, all this network 

of global reference—regional reference level to a national reference 

laboratory is, indeed, one of the best in class. 

I think in bacterial it has been an incredible accomplishment. 

USAID has been a proud supporter of that global network of reference laboratories for surveillance. 

As you go down, indeed, and as you go into the clinical phase it, 

indeed, depends on the network of laboratories on the ground. 

On the Xpert system, I think that we feel it really has been a 

game changer and it is in the process of scaling up and, Chairman 

Smith, I noted that in the year 2011 there were 500,000 cartridges. 

43

The cartridges are really straightforward and in 2 hours you can 

get a result that used to take 6 weeks or more in the regular laboratory. 

Now, from 500,000 we have increased tenfold by as of last year 

to about close to 5 million cartridges, which is quite significant, 

and this is being driven now by the demand of countries themselves. 

We are working with WHO, with CDC to provide us the technical 

guidance, technical assistance and the cartridges themselves are 

increasingly adopting these. India is now also working to develop 

even cheaper alternatives and maybe they will succeed. 

But they have been good to do other things and I think that that 

will add. The price of the cartridge itself came down from over $20 

apiece to less than $10 and that alone has helped us save over $50 

million in the last year or so. 

So I think that the economics of this system will allow us to continue the expansion and the demand because it is performing. 

Mr. SMITH. Let me just ask, the—2035—and this is not, why—

end TB by 2035. Alzheimer’s is 2025. The post-2015 so, say, the 

Sustainable Development Goals are 2030. Was that arrived at with 

some realistic set of benchmarks that might be achievable or is it 

aspirational? 

Dr. FRIEDEN. I would say it is aspirational. Fundamentally, we 

need to do two things in tuberculosis. First, implement what we 

know how to do but isn’t getting well implemented everywhere, and 

there is still a big gap between what we could be doing and what 

we are doing. 

Far too many patients are not getting promptly diagnosed, not 

getting effectively treated and far too much tuberculosis is spreading in healthcare facilities and elsewhere. 

We also need to continue to innovate. We need better diagnostics. 

We need better treatment and, ideally, we would need a vaccine. 

So I don’t see a clear pathway with the tools at hand to get to that 

goal. 

It is aspirational, but I do see a real urgency of doing those two 

things now—implementing what we know, better, for more patients 

and continuing to learn more. 

Dr. PABLOS-MENDEZ. Congressman, if I may add, TB is different 

than most other infectious diseases and you are really an expert 

because you have been looking to so many of them. 

But in many other diseases, as the problem of the disease 

shrinks and the manifestations shrink, usually the problem, indeed, is smaller and over time it is ended. 

With tuberculosis, because 2 billion people are estimated to be already infected, about 10 percent of which will activate the disease, 

as we heard earlier from Dr. Goosby, even if we could totally perfectly treat all cases of TB and MDR–TB today, you will still see 

TB coming up for decades to come. 

So, indeed, I think while it is a fact that we have moved from 

the control to stop as we now begin to see the declining incidence 

and dramatic declines in mortality, we can now move to a vision 

of elimination and to end tuberculosis. The tail end is going to be 

longer than some of the other diseases we are fighting today. 

44

Mr. SMITH. Bedaquiline, the first new drug in 40 years or 50 

years, you mentioned some others are in the pipeline. 

Now, is that just the U.S. pipeline or is it, as I suspect, the European pipeline as well and how less rigorous might their standards 

be vis-a-vis FDA that might get it onto the market sooner? 

Dr. FRIEDEN. There is a global collaboration to develop new 

drugs, and Dr. Pablos-Mendez can speak more about this. At CDC, 

we have participated in clinical trials in many countries. 

Tuberculosis control is interesting in that there really has been 

a global collaboration. The U.S. Public Health Service, the Medical 

Research Council of the United Kingdom, the Japanese, Hong 

Kong, many other countries have done some of the best studies of 

the drug efficacy for any disease ever over a period of decades. 

There is good global collaboration and there are definite standards 

for efficacy. 

One of the challenges with some of the newer drugs is that there 

may not be a large number of patients with drug resistance to be 

tested and that the outcomes may not be as good as we would like. 

But there are trials underway and there have been trials underway for some time to look at what may work better. The new drugs 

are encouraging, but exactly as was stated earlier, at this point 

their role is a reserve role for when the tried and true drugs that 

are so well documented to be both effective and safe are no longer, 

unfortunately, effective. 

Dr. PABLOS-MENDEZ. Well, the modern era of antibiotic randomized clinical trial started with tuberculosis streptomycin back in 

1948. 

We had a period of a lot of products coming in the 1950s and 

1960s and then we stopped and we have been using those which, 

when well deployed correctly can be very effective. 

But resistance is natural when you use an antibiotic and, indeed, 

that was the wake-up call back in the year 2000. 

In the last 15, indeed, the PPPs for tuberculosis: The NIH at the 

basic research levels, companies sharing their chemical libraries 

showing you companies who came with innovation. 

So now we have a richer pipeline. Tuberculosis is slow. The nature of the disease means the clinical trials are more complicated, 

as Tom alluded, and so we have a tradition of that partnership to 

tackle this. 

MDR–TB is particularly challenging but, nonetheless, so we are 

proud now we are entering an era of randomized clinical trials with 

new drugs for MDR–TB as well. 

Mr. SMITH. Let me ask you, Dr. Frieden, in your testimony you 

spoke of the 450,000 immigrants and 70,000 refugees who are rigorously screened and before entry into the United States have to 

be cured prior to entry. 

Since we do have a very sizeable number of people who are not 

legal, what can be done, what is being done to ensure that they are 

not carrying this disease? 

Similar to that with war and conflict being ever present in so 

many parts of the world, especially in the Middle East and Syria 

and Iraq, I am always reminded that more people died of the misnamed Spanish Flu than from World War I, and who knows if that 

was the proximate cause, but a lot of experts have suggested it 

45

probably was laying a groundwork for that terrible disease or that 

pandemic to occur. 

Is there a risk of a huge exponential explosion because of what 

is happening in places like Syria and Iraq? That would be global 

I am talking about, but especially in the maleffected area. 

Dr. FRIEDEN. In the United States currently, about two-thirds of 

all of our tuberculosis cases are among people who were born 

abroad. 

Those cases include people from China, from India, from Vietnam, Philippines, from South Korea, and many of them occur in 

people in who have been here for many years because, as has been 

discussed earlier, tuberculosis resides in your body and can be 

there for many years before you develop active tuberculosis. 

There are several things that we are doing to advance this and 

make further progress. You mentioned the program we have for 

immigrants and refugees. We think that is a highly successful program. 

It has been great for the immigrants and refugees. It has been 

great for their host countries, which have better services, and great 

for us in this country. 

One of the components of the antibiotic resistance proposal, 

which is now under consideration in Congress as part of the Fiscal 

Year 2016 budget, would expand some of that screening program 

for countries with very high rates of tuberculosis and high numbers 

of people coming into this country to long-term visitors such as people coming on certain kinds of work visas or student visas. 

In addition, it is very important that the services for tuberculosis 

patients in this country are provided to all patients with tuberculosis because it is in everybody’s interest that they get treated 

quickly and completely, and that is one of the things that we work 

very closely with health departments throughout the United States 

for. 

Our budget in the U.S. for tuberculosis control is a little bit over $140 million a year and with that we make sure that funds are 

available to treat every patient from a public health standpoint—

not just clinically, but to make sure that contacts are followed, that 

they are provided with support, that they receive directly their 

treatment to maximize the likelihood that they will be cured and 

not develop drug-resistant tuberculosis here because we know that 

if that were to happen it would cost us far more than the prevention costs us today. 

Mr. SMITH. In terms of ensuring that U.S. personnel and other 

healthcare workers around the world are properly protected, two of 

you today have said you have TB only because you cared enough 

to deal with patients who had TB. 

What could be done to protect our USAID people, our healthcare 

professionals, the NGO community? Is there enough being done 

along those lines? 

Secondly, I was concerned that the administration’s budget had a $45 million cut for TB. I am absolutely sure people in this room 

are no way a part of that. 

I will never forget when I was chairman of the House Committee 

on Veterans Affairs I asked Tony Principi, who was then the Secretary, who came in with a budget that OMB had slashed to bits 

46

and they said how much did you ask for that you didn’t get and 

he said about $1 billion, and we immediately moved the goalpost 

to include that $1 billion and got it, and he was raked over the 

coals. 

So I don’t want any of you to get raked over the coals, but if you had additional resources, $236 million is what is likely to be in the 

2016 budget. Is it enough? Not taking to task the proposed cut of $45 million 

but, Congress, in a bipartisan way said no, not going to happen, 

we at least want to get up to $236 million. 

How much more should be provided, in an ideal world where you 

really can say look, this is what we will do. We know, you know, 

Dr. Goosby, it is over $1 billion globally. If you could maybe speak 

to that. 

Dr. FRIEDEN. Let me take your first question first, Mr. Chairman. 

There are three things we can do to protect Americans working 

overseas from tuberculosis. The first is to improve the tuberculosis 

treatment programs in those countries because TB rates can actually come down quite rapidly. 

The study that I was part of in India, funded by USAID, done 

at what is now called the National Institute for Research on Tuberculosis, showed that you could get a very rapid control of tuberculosis prevalence by treating effectively and if you have got half 

as many patients around in just 5 years you have half the risk of 

getting infected. 

So the first thing is to help those countries have effective programs. The second is to improve infection and control in healthcare 

facilities. There is still far too much TB being spread in healthcare 

facilities all over the world and there are a series of things and at 

CDC we have launched a program called TB BASICS on infection 

control that has resulted in very rapid improvements in Nigeria, 

India and elsewhere in infection control in healthcare facilities so 

that it is less likely that any healthcare workers, U.S. or others, 

will get infected. 

The third is on a matter of personal health. It is very important 

for healthcare workers to be tested periodically to see if they have 

become infected with either the tuberculosis skin test or another 

more sophisticated or separate test that would look at whether or 

not you are infected and if you are infected to get preventive treatment. 

On your second question of resources, exactly 100 years ago in 

1915 one of the great public health leaders in New York City wrote 

that public health is purchasable. Within natural limitations, a 

community can determine its own death rate. 

That was Herman Biggs and he actually made his career on tuberculosis, establishing rapid diagnostic facilities throughout the 

city in the 1890s. 

So some things never change and some things do. But, clearly, 

there is a need for more resources to expand programs that are effective and also to offer countries around the world matching funds 

so that they will increase their expenditure as well and to advance 

innovation so that we have new tools to fight tuberculosis in the 

coming years. 

47

Dr. PABLOS-MENDEZ. Chairman Smith, thank you again, and you 

are right about our own staff facing risks and we do, of course, follow the guidance of those who interact with communities who are 

in difficult settings or who have themselves some vulnerabilities to 

follow guidance that exists to protect them against getting infected 

and against reactivating disease, and this is one of the many reasons you allow me. 

I will also—on Saturday—just on Saturday a special service to 

one of the staff of our partners implementing work in Mali, Anita 

Datar, was killed in the terrorist attack at the Radisson Blu Hotel. 

She represents the best of an American hero and we have many 

American heroes who have faced the ultimate sacrifice. But when 

you face the ultimate sacrifice by helping save the lives and improve the lives of others it deserves our greatest respect and recognition. 

On the budget question, you are right—and Tom has already 

made the point; the United States is right now the largest donor 

in the fight against tuberculosis and that is something we can feel 

very proud of not only through the bilateral line, the USAID budget, also through PEPFAR, through the NIH, through the Global 

Fund and I am going to talk to you next week when we will begin 

the replenishment conversation. 

We need to make sure all the countries remain committed also 

to the fight against AIDS, TB, and malaria. And we have seen the 

results of that commitment. As we said before, almost cutting mortality by half. 

Incidence was now reversed down and the diagnostic kits going 

fivefold, tenfold, and in treatment of MDR–TB threefold. We can 

and we need to do more. We need new tools. The current tools will 

get us into other trouble. 

That is, you treat a patient with MDR–TB, you develop total resistance, et cetera. But more importantly, we will continue to work 

in domestic resource mobilization. 

So we appreciate the support that you have entrusted in us. We 

are doing very well with those but we will need more. We will need 

more for the other countries to also come in. 

Mr. BERA. This is great bipartisan teamwork, Democrats and Republicans working together. I think both of you in your testimony, 

and Dr. Goosby, certainly talked about this. 

We can win this. We can eliminate tuberculosis, right. It does 

take a concerted effort and we just have to look at our own history. 

If we think about smallpox in the 20th century killed hundreds of 

millions of individuals just in the 20th century. 

But we came together as a world, as multiple countries, to eliminate smallpox and the last natural occurring case of smallpox was 

1977, I believe, in Somalia. 

We are close on polio. Now, it’s not apples to apples. We had a 

very effective vaccine for both polio and smallpox. But it took a focused worldwide effort to say we are going to eliminate this and 

we did it. 

So it is going to take that effort because the downside of not 

doing it is going to cost us exponentially much more money in resources and lives lost in morbidity. 

48

If—and maybe I will start with Dr. Frieden—if we are, you 

know, thinking about this, obviously, we don’t have a vaccine similar to what we had as a tool to fight against smallpox and what 

we are using to fight against polio. 

I do know that in Europe they use BCG a fair bit and, certainly, 

in endemic countries they use the tuberculosis vaccine for kids and 

others. Efficacy of that vaccine, you know, how does that fit into 

the arsenal? 

Dr. FRIEDEN. BCG is the world’s most widely used vaccine. It is 

used at birth in most of the world. It is effective at reducing two 

particular serious forms of tuberculosis in children—TB meningitis 

and miliary tuberculosis. 

Unfortunately, it has a very little effectiveness at reducing tuberculosis overall in children or in adults. There have been many efforts to develop better vaccines but they are challenging, and as 

you point out, with smallpox and polio we have had the benefit of 

vaccines. 

With tuberculosis, think of the world as those with healthy immune systems and those without healthy immune systems. Among 

those with healthy immune systems, tuberculosis control program 

can result in 95 percent cure rates and can cut the rate of tuberculosis in half in a decade or less. 

In the context of HIV and other immunosuppressive conditions, 

we have many more challenges and we have seen, of course, exponential increases in Africa. 

As we expand HIV treatment reconstituting the immune systems 

of whole communities, there is the documentation of a modulation 

and a reduction in the rate of tuberculosis. 

But right now, the goal to eliminate tuberculosis globally is aspirational and relies on new technologies. 

Dr. PABLOS-MENDEZ. Mr. Bera, first, I share the spirit that you 

alluded to and all our history. So I am thinking the big picture 

here and as you did with smallpox or now in the middle of polio. 

We are in the midst of a historical transition in the traditional 

challenges of global health. We have to always keep our guard up. 

That has been one of the key lessons of tuberculosis. 

But it is also beyond smallpox or now polio, which is close at 

hand, and thanks to Tom also for the leadership on that space. The 

reduction in measles over 80 percent, reduction in leprosy over 90 

percent. 

Many of the NTDs are now slotted for eradication as well. We 

are in a period of which it is possible. We have shown it is possible 

because we invested resources, the partnerships and the commitments. 

We can indeed roll back many of these things. The idea to end 

tuberculosis, while aspirational at this point, is directionally correct. 

As I said before, a few years ago we were still growing. Now we 

are going down and that is a very significant shift. We need to continue to make sure that we treat tuberculosis right. DOTs has been 

the most cost effective intervention that we have for 25 years. 

In SDGs, the Copenhagen Consensus lists the no-brainers and 

DOTs remains one of the no-brainer investments for regular TB for 

49

mortality among the poor and to prevent MDR–TB when done 

right. 

So I think that even though it will have a longer tail to end for 

the reasons we explained earlier about the infections—the long termination of the infection—that, indeed, the vision is correct, the direction is correct and I think this generation will get us to a point 

we couldn’t have imagined possible 20 years ago. 

Mr. BERA. Absolutely. So again, there is not enough aspirational 

thinking in this town. So let us aspire to what we don’t know exactly how to do today but we know that if we don’t think about it, 

if we don’t think about this in terms of elimination, we won’t get 

there. 

So if we are going to continue on this theme of kind of the aspirational goals, if we are laying out where we make our investments 

hypothetically, obviously, vaccine development, vaccine research is 

important, continuing to have therapies in our arsenal for the existing cases, et cetera. 

Tom, you touched on the fact that we can’t think about this in 

isolation because with healthy populations, you have got one approach. But as we saw in the 1980s and 1990s as HIV emerged, 

you saw this reemergence of tuberculosis. 

How would you go about treating these co-morbid conditions? 

Dr. FRIEDEN. If you go back 100 years, the TB social reformers 

talked about clearing out the crowded slums where there was no 

ventilation and people were together—the isolated people who were 

sick—and they went for better nutrition. 

Ironically, we have kind of come full circle. We recognize that 

while TB can be cured, we also have to try to improve the social 

context in which it occurs because that will reduce the rates—

something like expanding ARV—antiretroviral treatment—to all 

people who are HIV positive will dramatically reduce TB rates. 

But in terms of your question about prioritization, I would think 

of, broadly, four categories—diagnosis, treatment of disease, treatment of latent TB infection, and then vaccines. 

Vaccines are challenging since it is hard for us to do better with 

the vaccine than Mother Nature does and since we don’t have great 

immunity from tuberculosis from infection that makes it challenging but still well worth doing. A TB vaccine would be worthy 

of a Nobel Prize. 

For diagnosis we have lots of advances and the really exciting developments with molecular diagnosis are changing the way we do 

this. 

We now can identify most of the mutations that lead to resistance to first- and second-line drugs within a couple of days in sequencing in the laboratory and that is getting less expensive, more 

accessible, quicker. The computing power is big but we are learning 

more about that. 

In terms of treatment, we are looking at new regimens. One of 

the areas that I think is particularly exciting is the idea of improving the treatment of latent tuberculosis infection. 

At CDC, our clinical trials consortium working with others has 

identified a 12-dose regimen of weekly isoniazid and rifapentine directly observed as equivalent to other preventive regimens. 

50

So you have now got a 12-dose regimen completed in 3 months. 

If we could add that to studies that would help us identify which 

of the people with infection are most likely to progress the disease 

because currently it is 5 or 10 percent. 

So you are treating 85, 90, 95 people to prevent those five cases. 

And if we could identify those individuals then we could target preventive or treatment of latent TB infection there we might be able 

to drive down future cases quite substantially. 

So there are lots of really exciting areas for research in investigation and innovation and, of course, the way innovation works it 

may be something totally different from these that makes the difference. 

Dr. PABLOS-MENDEZ. Thank you. 

Indeed, the U.S. Government strategy on TB control that was released earlier this year that really brings all of the agencies together has clearly stated goals. It is to reach, to cure, to prevent. 

And to reach means, indeed, to go for those who currently are not 

being diagnosed and so improving the diagnosis is very important 

and we are doing that. 

Then to treat, cure is paramount. DOTs remains the basis, I 

think, for most of what we do in the TB control, but now MDR–

TB is very important. 

And then prevent—the vaccine, as you just heard the discussion 

on vaccines, but also infection control—very important. When we 

were in New York and the crisis that we had in Eastern Europe 

in prisons, New York hospitals, Eastern Europe prisons, if you 

don’t isolate patients, you just spread the disease. 

And so I will just stress that it is reaching, curing, and preventing disease is indeed where we are putting our money. It is 

working. 

We need to do more and we need to do better and the investments in research remains significant. We couldn’t be here without 

the research that we invested 10, 20 years ago. 

Mr. BERA. Talk about those investments and have outlined the 

U.S. investments in terms of combating tuberculosis as well as on 

many other conditions. 

Who are the big foundational players in philanthropy? Are Gates 

and others investing? 

Dr. FRIEDEN. Gates has done quite a bit in tuberculosis control 

as they have in other areas and they have done the whole gamut 

of research from vaccines to diagnostics to treatments to programmatic initiatives in both India and China as well as elsewhere. 

One of the challenges we have is that although we wish we had 

better tools and we hope we will have better tools soon, our currently existing tools are not being used for a large proportion of patients and that is something that we really need to urgently address. Other countries such as Japan also have traditionally invested substantially in tuberculosis control globally. 

Mr. BERA. So, first making sure the tools that we have available 

are actually available to the countries that need them, right. 

So, again, it brings us back to Gene Xpert, which really seems 

like—yes, try to get that out there as much as possible and get 

51

folks using it while we are discovering the next generation of diagnostic and therapies. 

Thank you. 

Mr. SMITH. Let me just ask one final question. 

The National Action Plan to Combat Drug-Resistant TB, is that 

soon going to be announced or has it? I might have missed it. 

Dr. PABLOS-MENDEZ. It is a very important plan and it is under 

development. We don’t have a date yet for the release. But you can 

see we are all champions and we have been working on it. 

Mr. SMITH. Finally, I just want to say, again, I think it has been 

very clear that our efforts are bipartisan and very strong. 

If there is a way this subcommittee could be of help, we are in 

constant contact with our friends on the appropriations side, Kay 

Granger and, of course, over on the Senate side as well. 

If there is a way we can be helpful let me know, let us know so 

we can rally the troops, so to speak. And is there any authority, 

any legal authority that you are lacking or a push that in legislation that might be helpful? 

Dr. Pablo-Mendez, you have been very helpful in helping us on 

our neglected tropical disease legislation, which I think will make 

a difference. You are doing a magnificent job on it but we always 

need to do more. 

So many people are walking around with parasites and worms. 

So if we could be of help, this subcommittee will have your back 

as best we can to push this. And it is an open door, obviously, because you are leaving. 

But I think the game changer, frankly, was in terms of getting 

people’s attention in Congress was that report from about a month 

ago, which you really just put in neon lights that this is the leading 

killer of people by infectious disease in the world. 

So if there is any specific authority you need or anything along 

those lines. 

Dr. PABLOS-MENDEZ. I will say that, first of all, thank you again 

because I know that you have been great champions across our programs in global health and for tuberculosis in particular and bringing attention with this hearing also. 

So it is part of what we need and it is very helpful. It has been 

helpful to our agencies. It is helpful in the U.S. Government as a 

whole. 

We have a coordination effort across the USG. CDC, of course, 

has been a partner all along and we have worked with CDC for 

many years, even before I was at USAID. 

We have a particular responsibility domestically but also great 

technical partners in the fights against TB globally. 

The NIH is the lead for research in tuberculosis. The USAID has 

the lead when it comes to the international TB control efforts and 

funding us on. PEPFAR, very important when it comes to TB, HIV. 

And so I think we have, as you can see in the plan, a coordination 

platform for efforts and domestically I think Tom can speak to us 

to how much more we will need. 

But I like the idea that you have for Dr. Goosby earlier of linking 

the parliamentarians to make sure that the voice of tuberculosis is 

heard across many other halls because we really need the support 

52

not only for my own taxpayers, as we said before, but also from 

others. 

Dr. FRIEDEN. Thank you, Mr. Chairman, for all of your support 

for issues to support people with tuberculosis as well as global 

health in general, and Dr. Bera, for your deep knowledge and experience with public health and your commitment to it. 

To answer your specific question about authorities, I think this 

is something about which we will be having discussions over the 

coming months. 

One of the things that we have thought about coming out of the 

Ebola response was are there things that would have allowed us 

to be even quicker in our response, even more effective than we 

were. 

So that is one area that we will be looking at and possibly coming back to you on. 

Mr. SMITH. Thank you. On that very thing, I recently met with 

a group that actually makes emergency vehicles that can carry 

Ebola patients. Turns out it is my district. 

I have no financial connection whatsoever. But when I sat with 

a great deal of attention, which I will convey to you, but it certainly 

would have applicability here as well. 

And we are told——

Dr. PABLOS-MENDEZ. I am happy to hear. 

Mr. SMITH [continuing]. That Liberia is very interested in this. 

So if our witness wanted to——

Dr. PABLOS-MENDEZ. We’re with you——

Mr. SMITH. Yes. 

Dr. PABLOS-MENDEZ [continuing]. We were here together in August the year before when it was really depth of the fear of Ebola. 

But, really, safe transportation was a big, big issue. And so any 

technology, any innovations that help us in that is certainly welcome. 

Mr. SMITH. Thank you. 

Dr. Bera, thank you, and thank you, gentlemen, and Dr. Goosby, 

thank you. 

Without objection, the hearing record will stay open for 5 legislative days. There are a number of people who would like to submit 

testimony and we have one from the American Thoracic Society. 

Without objection, so ordered, and the hearing is adjourned and 

I thank you very much. 

[Whereupon, at 3:39 p.m. the committee was adjourned.] 

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