```

[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]

                     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
        
        
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                      COMMITTEE ON FOREIGN AFFAIRS

                 EDWARD R. ROYCE, California, Chairman
CHRISTOPHER H. SMITH, New Jersey     ELIOT L. ENGEL, New York
ILEANA ROS-LEHTINEN, Florida         BRAD SHERMAN, California
DANA ROHRABACHER, California         GREGORY W. MEEKS, New York
STEVE CHABOT, Ohio                   ALBIO SIRES, New Jersey
JOE WILSON, South Carolina           GERALD E. CONNOLLY, Virginia
MICHAEL T. McCAUL, Texas             THEODORE E. DEUTCH, Florida
TED POE, Texas                       BRIAN HIGGINS, New York
MATT SALMON, Arizona                 KAREN BASS, California
DARRELL E. ISSA, California          WILLIAM KEATING, Massachusetts
TOM MARINO, Pennsylvania             DAVID CICILLINE, Rhode Island
JEFF DUNCAN, South Carolina          ALAN GRAYSON, Florida
MO BROOKS, Alabama                   AMI BERA, California
PAUL COOK, California                ALAN S. LOWENTHAL, California
RANDY K. WEBER SR., Texas            GRACE MENG, New York
SCOTT PERRY, Pennsylvania            LOIS FRANKEL, Florida
RON DeSANTIS, Florida                TULSI GABBARD, Hawaii
MARK MEADOWS, North Carolina         JOAQUIN CASTRO, Texas
TED S. YOHO, Florida                 ROBIN L. KELLY, Illinois
CURT CLAWSON, Florida                BRENDAN F. BOYLE, Pennsylvania
SCOTT DesJARLAIS, Tennessee
REID J. RIBBLE, Wisconsin
DAVID A. TROTT, Michigan
LEE M. ZELDIN, New York
TOM EMMER, MinnesotaUntil 5/18/
    15 deg.
DANIEL DONOVAN, New YorkAs 
    of 5/19/15 deg.

     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         KAREN BASS, California
CURT CLAWSON, Florida                DAVID CICILLINE, Rhode Island
SCOTT DesJARLAIS,                    AMI BERA, California
    Tennessee
TOM EMMER, MinnesotaUntil 5/18/
    15 deg.
DANIEL DONOVAN, New YorkAs 
    of 6/2/15 deg.
                            
                            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

 
                     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 1\1/2\ 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.
    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 
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 Ki-moon.
    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.
    As Chairman Smith said, 4,100 people a day die from TB. Of 
the estimated 9 million annual deaths from all infectious 
causes, 1\1/2\ 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 1\1/2\ 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.
    Serious detection and treatment gaps for drug-resistant TB 
remain. Of the $13 billion in TB funding required in 2015, 
about two-thirds 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 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:]
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
     
                              ----------                              

    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 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.
    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 HIV-infected 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 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.
    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 1\1/2\ 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.
    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 lower-income 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.
    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.
    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.

 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 
multi-drug 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, 1\1/2\ 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.
    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 second-line 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 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 drug-resistant 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 drug-resistant 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:]
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
     
                              ----------                            

    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 
supported 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 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 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.
    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.
    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 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 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.
    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.
    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 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.
    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 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 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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