[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]



 
               FIGHTING MALARIA: PROGRESS AND CHALLENGES

=======================================================================

                               HEARING

                               BEFORE THE

                 SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH,

                            AND HUMAN RIGHTS

                                 OF THE

                      COMMITTEE ON FOREIGN AFFAIRS

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                               __________

                            DECEMBER 5, 2011

                               __________

                           Serial No. 112-113

                               __________

        Printed for the use of the Committee on Foreign Affairs


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




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                                 ______


                      COMMITTEE ON FOREIGN AFFAIRS

                 ILEANA ROS-LEHTINEN, Florida, Chairman
CHRISTOPHER H. SMITH, New Jersey     HOWARD L. BERMAN, California
DAN BURTON, Indiana                  GARY L. ACKERMAN, New York
ELTON GALLEGLY, California           ENI F.H. FALEOMAVAEGA, American 
DANA ROHRABACHER, California             Samoa
DONALD A. MANZULLO, Illinois         DONALD M. PAYNE, New Jersey
EDWARD R. ROYCE, California          BRAD SHERMAN, California
STEVE CHABOT, Ohio                   ELIOT L. ENGEL, New York
RON PAUL, Texas                      GREGORY W. MEEKS, New York
MIKE PENCE, Indiana                  RUSS CARNAHAN, Missouri
JOE WILSON, South Carolina           ALBIO SIRES, New Jersey
CONNIE MACK, Florida                 GERALD E. CONNOLLY, Virginia
JEFF FORTENBERRY, Nebraska           THEODORE E. DEUTCH, Florida
MICHAEL T. McCAUL, Texas             DENNIS CARDOZA, California
TED POE, Texas                       BEN CHANDLER, Kentucky
GUS M. BILIRAKIS, Florida            BRIAN HIGGINS, New York
JEAN SCHMIDT, Ohio                   ALLYSON SCHWARTZ, Pennsylvania
BILL JOHNSON, Ohio                   CHRISTOPHER S. MURPHY, Connecticut
DAVID RIVERA, Florida                FREDERICA WILSON, Florida
MIKE KELLY, Pennsylvania             KAREN BASS, California
TIM GRIFFIN, Arkansas                WILLIAM KEATING, Massachusetts
TOM MARINO, Pennsylvania             DAVID CICILLINE, Rhode Island
JEFF DUNCAN, South Carolina
ANN MARIE BUERKLE, New York
RENEE ELLMERS, North Carolina
ROBERT TURNER, New YorkAs 
    of October 5, 2011 deg.
                   Yleem D.S. Poblete, Staff Director
             Richard J. Kessler, Democratic Staff Director
                                 ------                                

        Subcommittee on Africa, Global Health, and Human Rights

               CHRISTOPHER H. SMITH, New Jersey, Chairman
JEFF FORTENBERRY, Nebraska           DONALD M. PAYNE, New Jersey
TOM MARINO, Pennsylvania             KAREN BASS, California
ANN MARIE BUERKLE, New York          RUSS CARNAHAN, Missouri
ROBERT TURNER, New York As 
    of October 11, 2011 

                            C O N T E N T S

                              ----------                              
                                                                   Page

                               WITNESSES

The Honorable Mark Green, Senior Director, U.S. Global Leadership 
  Coalition......................................................     6
Dennis Schmatz, Ph.D., President of the Board, Medicines for 
  Malaria Venture North America, Inc.............................    12
Regina Rabinovich, M.D., Director, Infectious Diseases, Global 
  Health Program, Bill & Melinda Gates Foundation................    20
Mr. Roger Bate, Legatum Fellow in Global Prosperity, American 
  Enterprise Institute...........................................    26
David Bowen, Ph.D., Chief Executive Officer, Malaria No More.....    36
Richard W. Steketee, M.D., Science Director, Malaria Control 
  Program, Program for Appropriate Technology in Health..........    49

          LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING

The Honorable Mark Green: Prepared statement.....................     9
Dennis Schmatz, Ph.D.: Prepared statement........................    15
Regina Rabinovich, M.D.: Prepared statement......................    23
Mr. Roger Bate: Prepared statement...............................    29
David Bowen, Ph.D.: Prepared statement...........................    39
Richard W. Steketee, M.D.: Prepared statement....................    52

                                APPENDIX

Hearing notice...................................................    82
Hearing minutes..................................................    83
The Honorable Jeff Fortenberry, a Representative in Congress from 
  the State of Nebraska: Prepared statement......................    84
Mr. Roger Bate: Material submitted for the record................    86


               FIGHTING MALARIA: PROGRESS AND CHALLENGES

                              ----------                              


                        MONDAY, DECEMBER 5, 2011

              House of Representatives,    
         Subcommittee on Africa, Global Health,    
                                   and Human Rights
                              Committee on Foreign Affairs,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 3 p.m., in 
room 2172, Rayburn House Office Building, Hon. Christopher H. 
Smith (chairman of the subcommittee) presiding.
    Mr. Smith. The subcommittee will come to order, and good 
afternoon to everyone. I want to thank you for joining us for 
this very important hearing on malaria, one of the most serious 
health issues facing the developing world and particularly 
Africa today.
    For the last century America has been a leader in the fight 
against malaria. While the United States and several other 
countries have been able to eliminate malaria, this deadly 
disease still persists and presents a serious challenge to 
other parts of our world. The World Health Organization 
estimates that 781,000 people died from malaria in 2009, and 
that 225 million people have suffered from infection. Malaria 
is the fifth leading cause of death from infectious disease 
worldwide. It inflicts a particularly severe toll on people of 
sub-Saharan Africa where 90 percent of the deaths caused by 
malaria occur.
    Moreover, approximately 85 percent of malaria deaths occur 
in children under the age of five. Every 45 seconds a mother 
and father in Africa lose their child to malaria.
    There is also a far-reaching impact on the wealth and the 
development of countries with endemic malaria. Africa may lose 
up to $12 billion in productivity due to malaria each year to 
the disease, while the disease in turn consumes about 40 
percent of Africa's public health expenditures. These numbers 
and statistics are staggering, but they have a greater impact 
when one has been to Africa and met the individuals who must 
live with this dreaded disease.
    Anyone who spends any meaningful time in Africa and mingles 
with the African people notices the prevalence of malaria. When 
you ask someone whether he or she has ever had malaria, they 
will likely respond not with a yes, but with how many times 
they have suffered from it. More astounding than the sad 
reality that malaria is killing or harming so many millions of 
people is the reality that malaria is preventable and 
treatable. The world has the tools to prevent and to treat 
malaria. No one in the 21st century should have to suffer from 
it, let alone die from it.
    When I last visited Uganda, I visited several homes 
including a home in the remote region of Bushenyi. The three-
room dwelling of white-washed walls and dirt floors was 
particularly empty, and this made the insecticide-treated 
mosquito net over the floor mats all the more striking. These 
nets may seem like insignificant items when listed on paper, 
but they are noticeably visible in the modest homes of these 
families who rely on them for protection from this ravaging 
disease.
    What began in the United States as an effort to protect our 
troops abroad and citizens here at home has become for us a 
larger global health objective. In the last decade we have seen 
a renewed commitment by the United States, international 
organizations, and private foundations to eliminate all malaria 
deaths. The effort received a notable boost in 2007 when Bill 
and Melinda Gates renewed the challenge of worldwide malaria 
eradication.
    While much progress has been made in combating malaria, as 
we have seen from past eradication efforts, malaria can resurge 
when treatment becomes ineffective through drug resistance. 
While the global commitment remains to beat this disease, and 
to beat it as soon as possible, the stakes are too high to bet 
it all on doing so before the tools we have lose their impact.
    At today's hearing the subcommittee will receive an update 
on the progress toward malaria elimination in the most endemic 
countries with a focus on the vitality and the effectiveness of 
the treatment component. The hearing will examine the future of 
antimalarial drugs, vaccine development, and challenges in 
ensuring an adequate supply of effective medicines. We also 
will hear about the continued availability, affordability, and 
safe distribution of quality antimalarial medicines.
    I look forward to hearing the testimony of our very 
distinguished panel, all of whom have made and are making an 
enormous difference in the lives of people who are being 
ravaged by this disease.
    With that, I would now like to yield to my friend and 
colleague Mr. Payne for any opening comments he may have.
    Mr. Payne. Thank you very much, Mr. Chairman, and let me 
commend you for calling this very important hearing on the 
international community's progress toward eradicating malaria. 
I would also like to thank our distinguished panel who are here 
with us for agreeing to come to testify and to give us an 
update of the current state of the epidemic.
    I think you have heard the statistics just given by the 
chairman: 225 million cases, 781,000 deaths in over 100 
countries. It is an area that we wonder why it took so long for 
the world to really get serious about malaria. But of course, 
we know that because malaria impacted on areas where there was 
not considered to be a return on the investment, many 
pharmaceutical companies just did not spend time trying to come 
up with a cure or a prevention, because they figured if they 
did, who could pay for it?
    And so we have seen a sea change, though, in what is going 
on in the world today. We see many organizations now changing 
the manner in which they do, the fact that still though every 
45 seconds malaria claims the life of an African child. The 
fact that even in our country many years ago when our Nation 
first began, ambassadors from foreign countries were paid 
hazardous pay to come to Washington, DC, as ambassadors because 
of the problem of malaria, but we dealt with malaria and we 
eliminated malaria.
    However, there are a number of unintended consequences with 
global warming going on, although people are saying it is not 
man-made, we still don't have the science, et cetera. With the 
climates warming up again, we may see the fact that malaria 
will once again start to come into temperate zone countries 
because of the global warming, and the whole question of 
malaria could once again become an issue in the Western 
Hemisphere.
    The global fight against malaria is daunting, but it is 
winnable. This year I am pleased to welcome Congressman 
Fortenberry as my new co-chair of the Malaria Neglected 
Tropical Disease Caucus. We now have close to 60 Members in the 
House. Several years ago we were very excited when then-
Congressman Boozman became co-chair and we launched the Malaria 
Caucus with Ms. Laura Bush coming to the House on one of her 
very few appearances here. And we launched the Malaria Caucus 
with a great deal of bipartisan support, and he is still 
continuing to fight the good fight over in the Senate.
    The Senate Malaria Working Group led by Senator Coons and 
Senator Wicker, another former member of the House, is also 
enjoying bipartisan support. When we get bipartisan support we 
can conquer anything. I think we are doing that when we 
approach this question of malaria. In this time of difficult 
discussions on U.S. foreign assistance reform our malaria 
control and prevention commitments represents some of the 
strongest returns on investment for foreign assistance dollars.
    In the last few years through proven effective and low-cost 
intervention, the global community has been able to slash 
disease burdens and deaths in Africa and elsewhere in the 
world. Over the last decade, Zanzibar has managed to reduce 
both the number of confirmed malaria cases, as well as malaria 
deaths by 81 percent.
    Rwanda and Zambia have seen positive results through 
malaria control interventions as well, with Rwanda increasing 
the percentage of its population using net beds by 70 percent. 
Efforts to provide bed nets, indoor residential spraying 
treatment, and education are making a dramatic difference.
    As our global partners are working to address drug quality 
and control concerns, World Health Organization 
prequalifications of essential medicines has been shown to be 
an effective mechanism to reduce the abundance of substandard 
drugs on the market in countries that have a weak domestic 
regulatory authority. In response to the findings of 
substandard quality and antimalarials in Africa, WHO had 
suggested and assisted in implementing key recommendations to 
empower countries to improve regulations at the country level. 
All of the tremendous progress we have made in the fight 
against malaria will not be possible without the United States' 
leadership and our global partnership. However, all of the 
groundwork that the United States and the international 
community has made in this fight currently is at risk. There 
are those in Congress who feel that the United States should 
cut back our already modest investment in life-saving global 
health programs.
    I strongly disagree. The U.S. has a moral responsibility to 
be a leader in the fight and suffering worldwide through the 
Global Fund Initiative, the President's Malaria Initiative. And 
let me just mention we have so many great organizations--Roll 
Back Malaria, Medicines for Malaria Ventures, the Malaria 
Vaccine Initiative, the Abuja Declaration, the Global Fund to 
Fight AIDS, Tuberculosis and Malaria, The Global Fund, One 
World Health, the President's Malaria Initiative, Malaria 
Control and Evaluation Partnership in Africa, the World Bank 
Booster Program for Malaria Control in Africa, Malaria No More, 
Malaria Vaccine Technology Roadmap of 2006, the Global Malaria 
Action Plan, the Affordable Medicines Facility, and the African 
Leaders Malaria Alliance--all are working together in a 
coordinated effort.
    I have to commend Ray Chambers from my City of Newark who 
is the Special Envoy to the United Nations Secretary General 
for Malaria, and he and Peter Churnin are the ones who started 
Malaria No More; but Ray Chambers has done a fantastic job 
working on this, and of course, the Bill & Melinda Gates 
Foundation. Mr. Gates is involved in several of these 
organizations that I mentioned, and without him--I had the 
privilege to be at a meeting, it was like a fly on the wall, at 
the meeting with Mr. Gates and a number of people about 3 weeks 
ago, where they just talked about a war on malaria and the 
vision that there will be a vaccine created in our time in the 
future, in the near future.
    And so once again there is nothing that is passionate as 
this to me, and I commend the chairman for calling this 
important hearing. Thank you, I yield back.
    Mr. Smith. Thank you very much. Mr. Turner.
    Mr. Turner. Thank you, Mr. Chairman. I am interested in 
hearing what our distinguished and expert panel has to say. I 
yield back.
    Mr. Smith. Thank you, Mr. Turner.
    Without objection, I ask that the full remarks of Vice 
Chairman Jeff Fortenberry be made a part of the record. I would 
note for the record that he co-chairs the Congressional Malaria 
and Neglected Tropical Diseases Caucus, as noted by Mr. Payne. 
But he also authored an amendment to the State Department 
authorization bill that reaffirms our commitment to end malaria 
deaths by 2015. He is unable to be here today and his full 
statement will be made a part of the record.
    I would like now to introduce our distinguished witnesses 
and again thank them for the Herculean efforts they have 
expended in trying to eradicate this vicious disease. Beginning 
first, welcoming back Ambassador Mark Green, former Member of 
the House, who served with great distinction here. Ambassador 
Green is a senior director of the U.S. Global Leadership 
Coalition and has had an extensive career in public office. He 
served as U.S. Ambassador to Tanzania from 2007 to 2009, where 
he worked closely with Tanzanian leaders to combat diseases 
such as malaria and HIV/AIDS. From 1999 to 2007 he served in 
the House of Representatives as a member of the International 
Relations Committee. He played a leading role in crafting the 
Millennium Challenge Act as well as other key legislation that 
addressed the global struggle to eradicate malaria. Ambassador 
Green has also served as managing director of the Malaria No 
More Policy Center right here in Washington, DC.
    We will then hear from Dr. Dennis Schmatz who is president 
of the U.S. Board of Medicines for Malaria Venture, and has 
over 30 years of drug discovery experience. He was formerly the 
vice president of infectious disease research at Merck Research 
Laboratories. Dr. Schmatz has been involved with malaria 
research for his entire research career. He has served on and 
chaired a number of scientific advisory boards for the World 
Health Organization, including the tropical disease research 
program, and was founding member of the Medicines for Malaria 
Venture Expert Scientific Advisory Committee. He has a proven 
track record in managing large research teams across diverse 
therapeutic areas toward the successful delivery of novel 
medicines.
    We will then hear from Dr. Regina Rabinovich, who is 
currently the director of Global Health Infectious Diseases at 
the Bill & Melinda Gates Foundation, where she oversees the 
development and implementation of strategies for the 
prevention, treatment, and control of malaria. Dr. Rabinovich 
joined the Foundation in 2003. She previously served in various 
positions at the U.S. National Institute of Allergy and 
Infectious Diseases, where she participated in Children's 
Vaccine Initiative, and served as liaison to the National 
Vaccine Program Office. Dr. Rabinovich has also served as chief 
of the Clinical and Regulatory Affairs Branch of the Division 
of Microbiology and Infectious Diseases.
    Then we will hear from Dr. Roger Bate who is the Legatum 
Fellow in Global Prosperity at the American Enterprise 
Institute and a founding director of Africa Fighting Malaria. 
He researches international health policy with special interest 
in counterfeit medicines and malaria control. Dr. Bate has 
conducted extensive research in India and numerous African 
countries on the public health consequences of the counterfeit 
drug trade. He writes extensively on topics such as endemic 
diseases in developing countries as well as access and 
innovation in pharmaceuticals and international health 
agreements. He is author or editor of 14 books, 2 dozen peer-
reviewed journal articles, and hundreds of newspaper articles.
    We will then hear from Dr. David Bowen who is currently the 
CEO of Malaria No More. Until November 2011, Dr. Bowen served 
as the deputy director for Global Health Policy and Advocacy at 
the Bill & Melinda Gates Foundation. In this role he had the 
responsibility for interactions between the Foundation and 
governments worldwide on global health. Dr. Bowen was 
previously staff director for health of the Senate Committee on 
Health, Education, Labor and Pensions. From 2000 to 2002, he 
held a joint appointment as a visiting fellow in the Department 
of Health Care Policy at Harvard Medical School.
    And finally, we will hear from Dr. Richard Steketee, who is 
the science director for the Malaria Control Program at PATH. 
He previously served as an active-duty member of the U.S Public 
Health Service and has served in a number of positions at the 
Centers for Disease Control and Prevention. These positions, 
including chief of the Malaria Epidemiology Section, branch 
chief of the Prevention Services Branch, and chief of CDC's 
Malaria Branch. During his tenure with CDC, he lived in Malawi 
for 4 years working on malaria research. Dr. Steketee also 
provided expertise on malaria to a number of international 
consortia.
    Without objection, the fuller resumes of our very 
distinguished panel will be made a part of the record.
    I would like to now yield to my good friend and colleague, 
Ambassador Green, for such time as he may consume.

 STATEMENT OF THE HONORABLE MARK GREEN, SENIOR DIRECTOR, U.S. 
                  GLOBAL LEADERSHIP COALITION

    Ambassador Green. Thank you, Mr. Chairman and Ranking 
Member Payne and members of the subcommittee. I am truly 
honored to be appearing before this subcommittee and to have 
this chance to talk with you about an underpublicized success 
story, a great success story in American development policy. I 
also want to respectfully commend you for holding this hearing, 
because the final chapters in that story have yet to be 
written. As lawmakers such as yourselves, who obviously care 
deeply about Africa and the developing world, you are going to 
be the ones with pen in hand as we go forward in writing the 
final chapters.
    Very quickly, in terms of my own background, I myself 
suffered from malaria when I served as a teacher in Kenya in 
the mid-1980s. One of my students died from malaria shortly 
before I came back. I have also had the honor of helping to 
craft malaria policy from my days as your colleague on this 
committee, to my days as Ambassador to Tanzania, which is one 
of the original President's Malaria Initiative Focus countries. 
I have also had the privilege of advocating for malaria 
programs as a member of Malaria No More, and you will hear 
shortly from that organization's distinguished new CEO, Dr. 
David Bowen.
    Since you will be hearing from experts like Dr. David Bowen 
who are far more conversant than I am on the numbers and 
research associated with this great success story, I will try 
to confine my remarks to what I believe is in many respects the 
most exciting development in this long battle, and that is 
leadership, leadership right here in the U.S. and, more 
importantly, exciting leadership in Africa itself.
    As you have laid out very well, Mr. Chairman, malaria has 
been with us for centuries and it has claimed millions of 
lives. And there have been times when the world has scored 
remarkable victories, truly important victories, eliminating 
the killer disease from places like the U.S. and Europe. There 
have been times when it seemed that victory was in sight in 
some of the world's hardest-hit regions. Only to fall short.
    Members of the subcommittee, I honestly believe that this 
time the fight is different. These days the world is making 
real and sustainable progress. We have never been this close 
and we have never come this far in providing hope for 
generations of children and families all across the sub-Saharan 
Africa. Millions of lives have been saved and millions of lives 
can be saved in the years ahead. Most importantly, a new 
generation of strong African leaders is rising to take on the 
malaria challenge. While it is true that Africa cannot conquer 
malaria alone, it is just as true that the killer disease 
cannot be defeated unless Africans lead the way, and they are.
    At the 2009 United Nation's General Assembly, 14 African 
heads of state in government came together to rededicate 
themselves to the goal of ending malaria deaths by 2015. They 
launched a new coalition called the Africa Leaders Malaria 
Alliance, or ALMA. Just 2 years later, ALMA has grown to 41 
heads of state and government, including membership by the 
African Union itself. It has become an invaluable forum for 
leaders to share ideas and best practices and to collaborate on 
common challenges.
    In just its first year of existence, ALMA tackled important 
issues like securing universal access to artemisinin-based 
combination therapies to prevent drug resistance, removing 
taxes and tariffs on essential antimalarial products, 
increasing local production of high-quality, safe and effective 
antimalaria interventions, and the banning of monotherapies. 
That would not have been possible just 4, 5, 6 years ago.
    As you will hear today, the world's public health experts 
are armed with effective new tools and technologies. Just as 
with man's struggle against killers like smallpox and polio, 
our scientists have labored long and hard in pursuit of a 
vaccine against malaria. While, as you will hear more today, 
researchers can now report historic progress. The first ever 
large-scale phase 3 trial of a malaria vaccine is underway 
right now in Africa.
    Some of the most exciting developments in our drive to end 
malaria deaths come not from new technology, but new uses of 
existing technology, and that to me is truly exciting. Take the 
example of the simple mobile phone, something that I think all 
of us here take for granted. Mobile phones are commonplace in 
sub-Saharan Africa. In fact, most experts tell you that is the 
great growth market. But now, thanks to innovative ingenious 
leaders in both the public and private sector in Africa, they 
have become not just simple mobile phones but amazing 
logistical and analytical tools to address global health 
challenges. Perhaps one of the best examples is the Malaria 
Early Epidemic Detection System, known as MEEDS, which is 
funded in part by the American people through USAID, the 
Centers for Disease Control, and PMI.
    The islands of Zanzibar, as you probably know, are part of 
Tanzania. They have almost eliminated malaria from their 
shores. To help them cross the finish line of totally breaking 
malaria's death grip, the tool called MEEDS was created. 
Working with the Zanzibar Malaria Control Program, it was 
developed to detect the early stages of an epidemic within 2 
weeks of onset. Every single Monday, health leaders from 53 
different stations in Zanzibar use text-messaging technology to 
send into an automated server any positive tests that they have 
of malaria. If in fact there is a positive test or a tick up, 
if you will, they pounce on the epidemic with all of the 
interventions that we know about and work to erase it, to wipe 
it out. It is a partnership between pubic health leaders and 
Selcom Wireless. It is a remarkable example of taking an 
existing technology, bringing together the public sector, 
bringing together the private sector, and putting it to work. 
That is great leadership.
    Leadership in the fight is also coming from communities of 
faith. Nowhere in the world are faith networks more important 
or more influential than in Africa. Faith institutions, 
Christian and Muslim in particular, can reach towns and 
villages that are cut off all too often from limited 
infrastructure. And the message is that faith leaders express--
well, let's face it, they carry a lot more weight than any of 
us as politicians could ever hope to do.
    With one-fourth of the world's malaria deaths occurring in 
Nigeria, a coalition of interfaith groups, international 
organizations, and Nigerian health officials are working hard 
to deliver interventions.
    The Sultan of Sukoto, the most powerful Islamic leader, who 
represents 70 million Muslims, and the Catholic Archbishop of 
Abuja, his counterpart among Christians, launched an effort to 
train 300,000 imams, priests, pastors and ministers to carry 
the malaria prevention message to villages throughout the 
country. I don't have to tell you how important this unity is, 
not only for public health reasons and in fighting malaria, but 
quite frankly for what it means for our national security 
interests.
    In 2002 world leaders created the Global Fund to Fight 
AIDS, Tuberculosis and Malaria. The Global Fund now funds 
nearly two-thirds of the world's malaria projects. Launched in 
2005, the President's Malaria Initiative has increased funding 
from $30 million to $618 million. These extraordinary 
investments have enabled a rapid scale-up of proven 
interventions such as insecticide-treated nets and rapid 
diagnostic tests. That is American leadership that works, and 
it is American leadership that shows the world what we stand 
for, and it shows the best that America has to offer.
    You have tough choices to make, obviously, in the months 
and years ahead, but what I can say to you is investments we 
make in malaria are working, their success is measurable, 
verifiable, and predictable. We know these tools work, we know 
how to conquer malaria, a disease that has killed so many 
millions.
    In the last 5 years deaths from malaria have fallen by over 
20 percent, and malaria cases have dropped by 50 percent in 
over 40 countries worldwide, and that translates into millions 
of lives saved. There are always challenges and malaria is not 
exempt, but I continue to be impressed by the innovative 
efforts from the public sector and private sector. It is a 
remarkable success story.
    One last success story I wanted to point out to you that 
again shows the strength of leadership, public and private, and 
that is the challenge that Tanzania faced in trying to take 
care of its logistical challenge, how you actually get those 
interventions, those medical supplies, out to different parts 
of the country.
    The Global Fund helped the Government of Tanzania reach out 
to the private sector, and the result was a public-private 
partnership with an American organization that knows a thing or 
two about getting effective supply chains in place, an 
organization called Coca-Cola. Now Coca-Cola is providing 
technical expertise to individuals in Tanzania to develop 
stronger, more effective, and more extensive supply chains, 
better delivery to more places. That is a great success story 
that we can celebrate.
    So as we look to the future it is with a sense of great 
hope. We have come a long way in this fight. And those of us 
who were in the field 20 and 30 years ago, quite frankly if you 
would have told us then about the success that we would see, I 
am not sure that we would have believed you. This is a story of 
Republicans and Democrats coming together, this is a story of 
Americans working together with African leaders. This is a 
story of security experts, faith leaders, the world, truly 
coming together and it is a story to celebrate and to publicize 
because it is absolute proof that we can make a difference. 
Thank you, Mr. Chairman.
    [The prepared statement of Ambassador Green follows:]
    
    
    
    
    
    
                              ----------                              

    Mr. Smith. Thank you very much for your very encouraging 
testimony, but also the focus you put on leadership, and when 
that leadership is truly creative and determined, the huge 
benefits and consequences it actually yields. So thank you so 
very much.
    And personally, I want to thank you again for your personal 
leadership on this. You know how this place works, you know how 
the executive branch works, and you having lived in Africa both 
before and during your ambassadorship, you know what really 
works there. So your advice and counsel has been very, very 
helpful to the committee, to the Congress, and to the executive 
branch. Thank you.
    I would like to now yield such time as he may consume to 
Dr. Schmatz. Please proceed.

  STATEMENT OF DENNIS SCHMATZ, PH.D., PRESIDENT OF THE BOARD, 
       MEDICINES FOR MALARIA VENTURE NORTH AMERICA, INC.

    Mr. Schmatz. Mr. Chairman, Congressman Payne, and members 
of the subcommittee, my name is Dennis Schmatz. I am president 
of Medicines for Malaria Venture's U.S. Board, and I chair the 
MMV Expert Scientific Advisory Committee. Thank you for the 
opportunity to testify on the role that drug development plays 
in combating malaria in Africa and around the world.
    Since World War II when malaria disabled hundreds of 
thousands of our troops, the United States has been a key 
player in the development of malaria drugs. Those treatments 
originally deployed for our troops were used in the 1950s and 
1960s to assist in the first global wave of malaria 
eradication. As those drugs became less and less effective due 
to growing resistance to the parasite, the U.S. again became 
involved with malaria drug development for our troops in Korea 
and Southeast Asia.
    Since then, the United States has continued its leadership 
role in malaria drug research, in part to protect our continued 
interests around the world and in part to care for the greater 
than 200 million people who contract the disease each year. 
When these people sicken, they are unable to earn wages, unable 
to care for their children, and countries lose billions of 
dollars in GDP per year. Over 800,000 die each year, the most 
vulnerable being children under 5, and pregnant women in 
Africa.
    Continued investment in malaria drug research benefits both 
the U.S. and its allies, both troops and civilians, around the 
world. MMV receives funding from the U.S. Government from USAID 
and NIH, as well as from other foreign governments, including 
the United Kingdom, Switzerland, and Ireland.
    MMV is a private-public partnership based in Switzerland 
and registered as a 501(c)(3) in the U.S. Our mandate is to 
discover, develop, and deliver effective and affordable 
medicines to those who need them most. We need lead 
collaborations around the world to protect the most vulnerable, 
and to find new treatments that make management of malaria 
better, cheaper and easier, and to prevent transmission and 
relapse of malaria to finally help eradicate this disease.
    Protecting the most vulnerable, MMV can point to two recent 
successes. First, in 2009 we launched Coartem Dispersible in 
partnership with Novartis. Coartem D is a cherry-flavored 
pediatric formulation of the effective but bitter adult drug, 
Coartem. Before the development of this pediatric medicine, 
adult tablets were crushed and given to children, and dosing 
was approximate since children often spit or vomit it up, 
leading to suboptimal treatment.
    Since the launch of Coartem D, over 92 million doses have 
been distributed in 35 countries and it is rapidly becoming the 
preferred treatment for young children in Africa.
    MMV also partnered to manufacture and deliver injectable 
artesunate to treat severe malaria. Studies published in the UK 
journal, ``The Lancet,'' demonstrated that there were 
significantly fewer deaths using injectable artesunate versus 
the commonly used IV quinine. It is also much easier to 
administer than quinine and it has fewer side effects. Because 
of these other factors, Doctors Without Borders independently 
estimates that this drug could save some 195,000 lives each 
year.
    Since its launch in January, our partnership has been 
responsible for delivering over 1.1 million vials of this 
lifesaving drug, enough for 237,000 severely ill patients. 
However, there is still a number of unmet medical needs. 
Resistance to artemisinin, the primary compound in all the 
front-line drugs, appears to be developing along the Thai-
Cambodian border, the same location where the last great wave 
of malaria resistance to chloroquine developed.
    The last time this happened, the world was caught empty-
handed, with millions of people exposed to malaria and with no 
effective drug to cure their disease, our citizens among them. 
We simply cannot be caught empty-handed again. We must have new 
drugs at the ready to combat resistance when it develops. Those 
drugs simply are not there right now and should resistance 
emerge with no treatment to combat it, we will lose much of the 
successful work that has been accomplished to roll back malaria 
around the globe.
    Unfortunately, today's drugs are imperfect, either because 
the full treatment takes too long to complete or the cost of 
treatment prohibitive for those who need it the most. To solve 
this dilemma, MMV is working on a single-dose cure that is not 
based on artemisinin, and it could dramatically change the way 
that malaria is treated throughout the world.
    Such a drug, known as OZ439, is now in phase 2 studies. 
OZ439 originated from an MMV-sponsored partnership in Nebraska, 
also in collaboration with other partners around the world. If 
it lives up to its promise, OZ439 could be one of the most 
valuable gifts the United States has brought to the fight 
against malaria. In truth, though, because drug development is 
a complex scientific process and because there are often 
unexpected events during clinical development, neither MMV nor 
its partners can take the risk of depending on just one new 
molecule. Therefore, we are nurturing a portfolio of promising 
projects around the world, including several in the U.S., which 
can supply the next two generations of drugs to combat malaria.
    My distinguished colleagues on the panel will discuss the 
crucial places that preventions, such as nets and vaccines, 
vector control such as insecticides, and diagnostics play in 
fighting against malaria. These interventions and the continued 
development of new drugs against this parasite would be crucial 
in order to eradicate the disease. If there is anything the 
world learned in the last great foray into eradication is that 
overreliance on too few tools to fight this disease quickly led 
to defeat.
    The United States Congress and the executive branch to the 
President's Malaria Initiative, USAID, NIH, CDC and the Walter 
Reed are all key players in this arena. A future without 
malaria is within reach, but only if we stay vigilant. Without 
a continuous supply of innovative medicines, defeating malaria 
will not be possible.
    Thank for the opportunity to testify.
    [The prepared statement of Mr. Schmatz follows:]
    
    
    
    
    
    
    
    
    
    
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    Mr. Smith. Thank you very much, Dr. Schmatz. Thank you for 
the encouraging news but also telling us about the ongoing 
challenges faced by all of us in finding the drugs that will 
truly mitigate and hopefully eradicate and treat this disease.
    I would note parenthetically that sitting right behind you 
is Mark Tavlarides. As Ambassador Green said earlier, he once 
served up here where Mark used to sit right here as chief of 
staff for the human rights subcommittee under Gus Yatron. He 
did a great job. He was Democrat staffer, worked very well with 
the minority. We became great friends over the years, and I 
want to thank him for his leadership in helping this hearing 
come into fruition.
    Dr. Rabinovich, you are next.

  STATEMENT OF REGINA RABINOVICH, M.D., DIRECTOR, INFECTIOUS 
     DISEASES, GLOBAL HEALTH PROGRAM, BILL & MELINDA GATES 
                           FOUNDATION

    Dr. Rabinovich. I want to thank you, Mr. Chairman, Mr. 
Payne, Mr. Turner, and other members of the subcommittee for 
taking the time to focus on malaria and for your commitment 
over the years to robust U.S. investment in global health and 
development.
    We have come a long way in malaria from just 10 years ago. 
Since 2000, more than 1 million African children have been 
saved from malaria. Approximately half of all countries with 
malaria have reduced malaria cases and deaths by 50 percent or 
more. This tremendous progress against malaria has been due to 
innovation and prevention and treatment, increased funding, and 
political will.
    New tools such as long-lasting insecticide-treated bed 
nets, and artemisinin-based and combination therapy, along with 
prevention during pregnancy, and indoor residual spraying, all 
of these have made this progress possible.
    The U.S. President's Malaria Initiative, the Global Fund to 
Fight AIDS, TB and Malaria, and the World Bank are essential to 
the remarkable successes in malaria control. The Global Fund 
alone has distributed 190 million bed nets to protect families 
from malaria.
    I was trying to think about how big you would require a 
container to hold 190 million, to make that clear, but it is a 
tremendous effort and one that is worthy of note.
    The President's Malaria Initiative provides lifesaving 
prevention and treatment to millions of people in Africa and 
Southeast Asia. However, even today, malaria has a 
disproportionate impact on the world's poorest and most 
vulnerable individuals and still kills far too many children 
each year. Our children here in the U.S. do not have to suffer 
from malaria. No child anywhere should.
    Maintaining the gains achieved today in malaria control is 
essential, but it is not assured without the continued 
commitment of multiple partners, including the U.S. Government. 
Guided by the principle that all lives have equal value, the 
Bill & Melinda Gates Foundation works to help all people lead 
healthy and productive lives. Our Global Health Program seeks 
to ensure that lifesaving advances are developed and that they 
reach those who need the most.
    In malaria we focus our efforts on improving existing 
tools, on discovering new ones to reduce and prevent malaria 
transmission, and, in the long term, to eradicate malaria 
worldwide.
    Existing interventions have contributed to a 20-percent 
decline in mortality due to malaria. We must continue to 
improve access to intervention like long-lasting insecticide-
treated bed nets, indoor residual spraying, and treatments that 
save lives. The impact of tools available right now is very 
real. However, the malaria parasite has a history of adapting 
to drugs and adapting to insecticides. Drug resistance to the 
most effective drug available, artemisinin-based and 
combination therapy, is developing and has been recognized in 
Southeast Asia.
    Research and development is essential because the 
preventive tools available today that are so effective at 
controlling malaria are not sufficient to control malaria in 
the long term or for eradication, due in part to the 
development of the resistance. Today the world has the 
strongest research and development pipeline for malaria that 
has ever existed, and we must ensure that it stays this way. 
Significant credit goes to the National Institutes of Health, 
which is one of the primary funders of malaria research and 
development.
    When I left the National Institutes of Health to join the 
Malaria Vaccine Initiative, I was asked why I would bet my 
career in creating a malaria vaccine, something that did not 
exist and which had been troubling to many initiatives 
previously. At the time, I didn't really have an answer based 
on impact. Most researchers were not convinced that the 
scientific path to a malaria vaccine was clear. And even if our 
work resulted in promising candidates, we did not know how we 
would finance or how we would deliver them. After all, at the 
time, which was about a decade ago, even the cheap and broadly 
available measles vaccine was not being used worldwide.
    In the last 10 years a lot has changed. We are much closer 
to having a malaria vaccine that works, through significant 
efforts by the PATH Malaria Vaccine Initiative and by many 
partners. It is possible a malaria vaccine will be available by 
2015. We have seen interim results for the RTS,S malaria 
vaccine, which were announced in October and published in the 
``New England Journal of Medicine.'' It showed that that 
vaccine, so far, prevents clinical malaria in 56 percent of the 
trial participants over a period of 1 year, and these are the 
first results. Those results are exciting. We now have proof it 
is possible to create a vaccine that is effective against 
malaria.
    The U.S. Government, through funding through the Department 
of Defense and USAID, has played an important role in 
development of this vaccine.
    Research is also underway on other vaccine candidates, 
including transmission-blocking vaccines which would prevent 
people infected with the malaria parasite from passing the 
disease on to mosquitoes, who would then infect other people, 
or, if vaccinated, not infect other people. In the effort for 
malaria eradication, these vaccines will ultimately be 
invaluable. However, significant work is still needed on the 
development of vaccines, and the U.S. Government will continue 
to play an important role in supporting these efforts.
    The Gates Foundation also invests in development of new 
drugs and methods to control mosquitoes. And there are today 
significant potential on both fronts. Medicines for Malaria 
Venture, as we heard from the previous speaker, is developing 
new drugs with entirely new classes of action, including a 
potential single-dose cure which would radically improve our 
ability to treat malaria in the field.
    The Innovative Vector Control Consortium and other partners 
are working on new insecticides for bed nets and entirely new 
methods to control mosquitoes that could look like the mosquito 
coils we use in our backyards or wall linings, with 
insecticides that are easier to use than bed nets. We must 
continue to support the development of new treatment and 
preventive measures to ensure that we stay a step ahead of the 
evolving parasite.
    We have reached an inflection point, a moment in which we 
either forge ahead and ensure permanent progress in the fight 
against malaria, or we slide back and run the risk of losing 
much of what we have already achieved. This is not the time to 
relax our guard. We cannot afford to accept partial success. To 
fight malaria we have to maintain momentum. We are either 
gaining ground or we are losing it. Resistance to drugs and 
insecticides is a very real threat. We have come too far to 
accept backsliding in the fight against malaria.
    In the face of today's challenges, there is one primary 
reason that I am optimistic for the future of malaria, and that 
is the commitment and dedication of so many people here in the 
U.S. and around the world, from scientists and researchers, 
program managers in the field, political leaders, and 
partnerships faith-based organizations and nongovernmental 
organizations that have emerged to fight this disease. I am 
optimistic that we must face the current situation with 
urgency. Malaria fights back and recent gains could be lost. We 
need to be smarter, we need to act faster. We must continue to 
fund the President's Malaria Initiative and the Global Fund. 
This funding saves the lives of children, women, and entire 
families.
    We also recognize funding is needed to develop new 
treatments and methods of prevention and to deliver more 
effective and affordable interventions. The Gates Foundation's 
long-term objective is the eradication of malaria, but we can 
only achieve eradication if we act urgently and maintain 
attention and funding today. We are committed to fighting 
malaria for the long haul. Commitment and leadership by diverse 
partners, including the U.S. Government, African leaders, 
nongovernmental and faith-based organizations, and the private 
sector is critical.
    It has been an honor to appear before you today. I 
appreciate your time and I look forward to a productive 
conversation.
    Mr. Smith. Thank you very much for your testimony and 
leadership.
    [The prepared statement of Dr. Rabinovich follows:]
    
    
    
    
    
    
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    Mr. Smith. We now turn to Dr. Bate.

     STATEMENT OF MR. ROGER BATE, LEGATUM FELLOW IN GLOBAL 
           PROSPERITY, AMERICAN ENTERPRISE INSTITUTE

    Mr. Bate. Mr. Chairman, members of the committee, thank you 
very much for inviting me to testify on this extremely 
important topic. Just over 7 years ago, I testified before the 
committee on what was then a relatively weak effort against 
malaria. The United States Government and other donors were not 
funding all viable control measures. The most politically 
charged was the lack of the use of insecticide DDT, but, as 
important, was the lack of support for the best malaria drugs.
    Not long after that hearing, the reforms and funding began 
in earnest. The U.S. Government started implementing all 
interventions. The Global Fund ramped up spending on both 
preventative and treatment efforts, including the best drugs to 
fight malaria the artemisinin combination therapies (ACTs), 
which have already been mentioned.
    Progress was swift and impressive, particularly in 
locations targeted by the President's Malaria Initiative, 
particularly the island the Zanzibar. And for those efforts and 
other efforts, the President's Malaria Initiative in my 
estimation is deserving of continued, even increased, support.
    The Southern African Development Community is targeting 
malaria elimination in eight countries, starting with Botswana, 
Namibia, South Africa, and Swaziland. With enough political 
will, elimination is a real possibility relatively soon. So 
overall there is good news. I would echo every comment that has 
been made by every speaker so far. And I stress it is good 
news, because I intend on spending the bulk of my time 
discussing some of the significant challenges that I see that 
remain. And those discussions are going to revolve around 
problems related to drug resistance. There are others I could 
mention; mission creep in certain agencies, and procurement 
problems which is increasing mortality in certain occasions. We 
may get to those in questions.
    But as has already been mentioned, the artemisinin 
combination therapies are the best treatment available. 
Resistance is being noticed on the Thai-Cambodian-Burmese 
borders, and resistance is likely to increase.
    I am going to cover a few reasons as to why I see that to 
be the case. The first is fake and substandard antimalaria 
medications are a significant, and probably a growing, problem. 
It is uncertain how many poor-quality antimalarials there are 
on the market in Africa, but it is certainly not a negligible 
amount. Many of these inferior-quality products are not illegal 
in the countries in question.
    Of the sampling that my research team and colleagues around 
the world have done, we found that roughly about half the drugs 
that failed quality control contain artemisinin, so they are 
directly contributing to resistance. There is also an 
increasing proliferation of brands, legitimate and otherwise, 
in many countries in the world. Nigeria has already been 
mentioned. Nigeria and Kenya have over 200 different brands of 
artemisinin therapy on sale.
    Working with the American Enterprise Institute, you would 
not be surprised to know that I am in favor of free trade and 
open markets, but this is not a controlled market. There is a 
considerable free-for-all in these markets and its quality 
control is bad because the medical regulation authorities in 
those countries have limited capacity.
    There is a significant positive note that the U.S. 
Government is supporting via the U.S. Agency for International 
Development--the very excellent program on quality medicines at 
U.S. Pharmacopeia, which is combating fake and substandard 
drugs, and helping developing-country medical regulatory 
authorities to identify unregistered illegal medicines and 
whether they cause problems. Most will on the market.
    Again, from different research that colleagues of mine have 
undertaken, unregistered medicines on the whole fail quality 
control tests five times more often than registered medicines. 
So simply getting the medical regulatory authorities to control 
what is on the market for antimalarials, I think, is important. 
The U.S. Pharmacopeia program, to the tune of $35 million, is 
in my opinion deserving of continued and increased support.
    The second major problem related to increasing resistance 
has already been mentioned. That is the sale of monotherapies. 
Coordinated action and attempts for the last 6 years to remove 
these from the markets, in Africa in particular, have had some 
success. But there are still some companies, a few companies in 
China, Vietnam, and to a lesser extent India, that are still 
producing them. This is a major contributor to resistance.
    In order to combat those monotherapy sales and replace them 
with ACTs, a team at the Institute for Medicine suggested 
subsidizing ACTs in the private sector, where most people buy 
their drugs. In the poorer regions, probably around 70 percent 
of drugs are bought privately.
    The Affordable Medicine Facility for Malaria is currently 
being piloted by the Global Fund in eight countries. This is an 
interesting idea. It may have a significant impact where it 
works well, but from my assessment of it, this is a project 
that has run ahead of itself. It is not achieving its aim. Even 
though we are in the first year and the first pilot phase, we 
are already beginning to see significant problems. For 
instance, the AMFm is exacerbating existing problems with 
diagnosis. This is not unique by any means to the AMFm, but it 
is increasing the number of people being treated with malaria 
drugs who do not have malaria.
    Secondly, there are ordering practices going on. We have 
already heard Zanzibar has almost eliminated the disease, yet 
243,000 ACT treatments were authorized by the Global Fund for 
Zanzibar, and 70 percent of all of the orders for AMFm are for 
adult treatment. Malaria is primarily a childhood disease.
    So there are significant problems that we are noticing out 
there. The subsidy is supposed to massively reduce the price of 
these drugs. Looking in 37 pharmacies in Nigeria and Ghana, my 
research team found that the drugs were two to five times 
higher in price than had been expected. Yes, they are lowering 
the price of ACTs, which is good. They are driving out some of 
the monotherapies. But the impact is still very worrying. 
Perhaps most worrying of all is that four pilot countries--
Kenya, Nigeria, Ghana, Tanzania--account now for 80 percent of 
the annual global ACT production capacity if all of those 
orders are fulfilled. That is a major problem.
    The United States Government so far has boycotted the AMFm, 
and I think for good reason. And you might wonder why I am 
mentioning the AMFm if the U.S. Government isn't funding it. 
Well, I think the U.S. Government procurement program of 
malaria treatments are going to be seriously curtailed. I 
already know that there will be serious problems in procuring 
medicines over the next 6 months.
    All in all, the AMFm is disrupting distribution systems and 
causing medicine procurement to operate on a first come/first 
served basis, creating huge problems. The Global Fund already 
doesn't have enough funding to fund its round 11, and it is 
probably short of funding for the AMFm. In my opinion, it 
should probably be stopped now before it completes the initial 
phase. I like experiments, I like to try and find out when 
things work. This is an innovative idea. If it continues 
through the first phase, we might learn enormously interesting 
information. In my opinion, the U.S. Government should work 
harder to end the AMFm, or at least limit its scope, before 
even greater damage is done to distribution systems, and it has 
a harmful effect on drug resistance.
    I could go on on other potential challenges, but I will end 
there, thank you.
    Mr. Smith. Dr. Bate, thank you very, very much.
    [The prepared statement of Mr. Bate follows:]
    
    
    
    
    
    
    
    
    
    
    
    
    
    
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    Mr. Smith. Dr. Bowen, please proceed as you would like.

   STATEMENT OF DAVID BOWEN, PH.D., CHIEF EXECUTIVE OFFICER, 
                        MALARIA NO MORE

    Mr. Bowen. Chairman Smith, Ranking Member Payne, Mr. 
Turner, and members of the subcommittee, thank you for the 
opportunity to testify on the great strides we have made and 
are making toward eliminating malaria as a public health 
threat. Members of this committee on both sides of the aisle 
have been great champions in the fight against malaria and your 
support has helped save countless lives.
    I would like to echo Ambassador Green's comment that this 
is an under-publicized and under-appreciated success story 
against a disease literally as old as humanity itself.
    I am David Bowen, the CEO of Malaria No More, an advocacy 
organization which was established 5 years ago, at the White 
House Summit on Malaria. Thank you, Ambassador Green, for that 
very generous introduction. Yours are very, very big shoes to 
fill.
    Malaria No More works to raise awareness and build support 
for the fight against malaria among policymakers, the public, 
businesses, and we have helped provide 2.7 million lifesaving 
mosquito nets. Thanks to a global partnership of government, 
the private sector, faith-based organizations, and community 
leaders across the world, there have been remarkable advances 
in the fight against malaria. Global malaria deaths have fallen 
by over 20 percent, and in less than 5 years malaria cases have 
been halved in over 40 countries, and childhood deaths from 
malaria fell by over 200,000. Yet the fact remains, the 
unacceptable fact remains that malaria still kills a child 
every 45 seconds.
    To address this major health threat, the President's 
Malaria Initiative was launched in 2005 by President George W. 
Bush, with strong bipartisan support from Congress, and has 
been continued and expanded under President Obama. Since its 
founding, PMI has distributed over 30 million insecticide-
treated mosquito nets, provided over 67 million lifesaving 
antimalarial treatments, and protected more than 27 million 
people as a result of indoor residual spraying.
    The successes of PMI have been many, and a fuller list of 
examples is provided in my written testimony. But here I will 
mention just two. In Senegal, PMI documented a 40 percent 
reduction in child deaths between 2005 and 2010; and in 
Tanzania, child deaths fell by 28 percent in the same period.
    The success of PMI is inextricably linked to the efforts of 
the Global Fund. In his annual report the leader of PMI, 
Admiral Ziemer, stated, ``Coordinating PMI investments with 
local initiatives financed by the Global Fund is critical to 
the success of both the Global Fund and PMI.''
    Under the leadership of George W. Bush and with bipartisan 
support in Congress, the U.S. pledged the founding donation to 
the Global Fund in 2001, and the U.S. continues to be its 
largest single donor. By law, the U.S. does not contribute more 
than 33 percent of the total funding, thereby leveraging $2 
from other donors for every $1 invested by the U.S. taxpayer. 
The Global Fund provides nearly two-thirds of all malaria 
funding and has provided approximately 200 million bed nets and 
treated 230 million cases of malaria.
    Through PMI and its contributions to the Global Fund, the 
U.S. is helping win the battle against malaria today. And U.S. 
support is just as indispensable to the effort to develop new 
ways of fighting malaria in the days to come. A remarkable 
innovation in this fight, as you have heard and you will hear 
further, is the RTS,S vaccine which has proven that additional 
protection against malaria is possible.
    Since the days of Walter Reed himself, the U.S. has been a 
leader in malaria research. And this proud tradition has been 
carried on with distinction by the Walter Reed Army Institute 
of Research which worked with GlaxoSmithKline and PATH to 
develop this impressive new vaccine. Sustained support for 
malaria R&D is crucial in developing new ways to prevent and 
treat malaria, as well as in combating the threat of drug and 
insecticide resistance.
    The remarkable progress made in recent years is critically 
dependent on robust funding. We are making major progress 
toward the day in which the world can say that malaria, like 
smallpox, is a disease of the past. This dream cannot be 
realized unless U.S. bilateral and multilateral funding remains 
strong. Through an investment of less than 1 percent of our 
budget, the U.S. saves and improves millions of lives, helps 
build robust current and future trading partners around the 
world, and contributes to our national security.
    Just this week AFRICOM published a statement indicating 
that malaria remains a direct threat to the health of U.S. 
personnel in that command. More indirectly, but just as 
crucially, widespread disease can contribute to the 
destabilization of a society, leading to failed states. 
According to the National Intelligence Strategy published under 
President Bush in 2005, ``Failed states are a refuge and 
breeding ground of extremism.''
    Investing in global health is critical to advancing our 
economic interests and building jobs at home. History has shown 
us that today's aid recipients often become tomorrow's 
consumers of American goods.
    Eleven of the 15 largest importers of American goods and 
services are former recipients of U.S. foreign aid, including 
South Korea, Taiwan and Brazil.
    A recent African Development Bank report states that 
Africa's income is expected to triple in the next 50 years. 
African countries as potential markets for American products 
can only be successful if their consumers are healthy and 
productive.
    The road to eliminating malaria deaths will not be easy. A 
fundamental requirement is the proper use of taxpayer funds. We 
must and will work against misuse of funds in any form and must 
also employ every feasible mechanism to guard against 
counterfeit or substandard medication.
    Malaria No More is dedicated to achieving measurable 
results. That is why we have partnered with the African Leaders 
Malaria Alliance, ALMA, through which African nations are 
holding themselves accountable by scoring their progress on 
country led efforts and sharing best practices.
    You have already heard from Ambassador Green about the 
leadership ALMA has shown in the fight against malaria. I just 
want to highlight one thing, which is the scorecard that ALMA 
has produced, ranking each country on their progress against 
definable measures.
    These kinds of scorecards provide clear public evidence 
about who is doing well and who needs to improve. We are 
optimistic that with robust support from the U.S. Government, 
we can continue the remarkable momentum of the last 5 years and 
bring forward the day which no child dies of this preventable 
disease. As a result of U.S. leadership, more children than 
ever before are surviving to see their fifth birthday and 
spending more time in school, giving them hope for a brighter 
tomorrow. More parents are able to spend time working to 
improve the lives of their children, their families and their 
communities. Thank you for the opportunity to testify, and I 
would be happy to take any questions.
    [The prepared statement of Mr. Bowen follows:]
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
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    Mr. Smith. Dr. Bowen, thank you very, very much.
    Now our final witness. I do thank for your leadership as 
well, so please proceed.

   STATEMENT OF RICHARD W. STEKETEE, M.D., SCIENCE DIRECTOR, 
MALARIA CONTROL PROGRAM, PROGRAM FOR APPROPRIATE TECHNOLOGY IN 
                             HEALTH

    Dr. Steketee. Thank you very much, Chairman Smith and 
Ranking Member Payne and Mr. Turner and other members of the 
subcommittee.
    It is a real pleasure to be here and I appreciate following 
a number of strong reports from each of my colleagues here at 
the table. Let me highlight a couple of things. One is that 
this progress has also shown us the incredible speed of change 
and innovation as we have gone forward, and it has been done 
through a remarkable partnership both within this country and 
across many nations. The second issue that I will come to, 
though, is that this progress is fragile and we need to pay 
attention because while there is speed in change and progress, 
holding that and going forward with it is and will be the true 
test for all of us.
    So just a little history: 1,000 years ago, we had just a 
name for this. Malaria comes from mal air or bad air, and that 
is what we thought caused it. It was just over 100 years ago 
that we actually identified the parasite and recognized that 
humans transmit them to mosquitoes and those mosquitoes 
transmit them to other humans. It was just over 50 years ago 
that we embarked upon a malaria eradication program globally. 
With actually huge success--and you may hear different stories 
about that--but included in that was the United States 
eliminated malaria. And I was 19 years old when it certified 
its malaria eradication in the United States with the World 
Health Organization.
    Since that time, we actually had a hiatus after that global 
malaria eradication program. The scientists didn't stop 
working, but there were essentially no resources. And in 
addition to that, the global malaria eradication program had 
never really gone to Africa. It had left out the hardest place 
in the world.
    At the end of the 1990s, particularly with the attention 
from leadership in Africa, we ended up with new leadership 
amongst the U.N. agencies and then that followed with 
resources. So this last decade, the first 5 years was 
essentially countries coming together and getting better plans, 
and we have that documented actually quite nicely.
    But the subsequent 5 years mark when the money came, the 
Global Fund was developed, the U.S. President's Malaria 
Initiative and the World Bank Booster Program all came together 
and funding went from about $100 million a year of external 
assistance to malaria in 2000 to $1.6 billion in 2009 and 2010. 
Unfortunately, $1.6 billion is actually still relatively small, 
but it has made an enormous difference in what has occurred.
    That is a more than tenfold increase in the funding and 
that has been followed by essentially a tenfold reduction in 
the incidence of infection and that has led to the saving of 
essentially 1.1 million child lives in sub-Saharan Africa in 
the last decade, almost all of which has occurred since 2007. 
The hospitalizations and the outpatient visits for malaria have 
been reduced by 50 percent in at least 10 African countries and 
essentially almost all of the countries outside of Africa.
    That burden of all of those health visits actually saves 
money. The number of blood transfusions has markedly reduced; 
and to walk into a ward that used to be full of children 
getting blood transfusions and today seeing that work with one 
or two patients, sometimes empty, is the remarkable progress 
that has occurred. The countries show their ability to deliver 
this, and that is part of the partnership that has gone 
forward.
    So we have had many interventions out there, and we have 
always had concerns about whether or not this could go forward 
with actual country leadership and countries demonstrating that 
they could do the work. And as Dr. Rabinovich mentioned, the 
concept of 190 million bed nets into homes is a remarkable 
logistics effort. It is not perfect. There is still much work 
to be done, but that is truly remarkable.
    Another issue in this is the fact that this money has gone 
widely, and it has come from wide places. So U.S. leadership in 
this and particularly the President's Malaria Initiative and 
the combined contribution also to the Global Fund have allowed 
us to do the right thing as Americans and the right thing to 
influence global donors because it is through the Global Fund 
that we have additional leverage to encourage other donors to 
come forward. And that has proven to be remarkable.
    In addition to that, the Global Fund has reached out and 
essentially supported programs in, I believe, 82 countries for 
the malaria control and that is 82 out of the 100 nations that 
have malaria. With all due respect to the 18 that didn't get 
resources, they are the ones that are almost ready to 
eliminate.
    So, in addition to saving more than 1 million child lives 
in this last decade, we also have eliminated malaria 
transmission in four countries and certified that under WHO 
leadership. We have set goals between now and 2015 to eliminate 
in 10 additional countries, all of which is thought to be 
entirely doable as long as resources are available.
    Another aspect to be aware of is that some companies have 
invested in this, and we have actually been able to document 
that. Sugar industries in these countries, some mining 
companies, both for copper or for precious metals. Where the 
company provided prevention to their workforce and the families 
of their workforce, and then realized that the decreased number 
of health visits and the improved productivity of their workers 
meant that they got a return for every dollar invested. They 
essentially made back an additional dollar in lower costs and 
improved productivity. And that is a pretty good return on 
investment. So there has been a huge amount of work and 
investment by many people.
    The financing nations, ours included, the many agencies, 
the scientists and the countries themselves, where we have a 
little bit of trouble counting the money that individual 
countries have put into malaria control. That is a hard number 
to come up with because they pay the salaries of all their 
health workers. They support the facilities that they work in. 
And it is through that and the logistics systems that are 
supported by external funding and the commodities that are 
supported that actually allow them to deliver really important 
services.
    This demonstrated and remarkable success is just as fragile 
as it has been innovative and fun. What we do today is actually 
categorically different than what we did just one decade ago. 
We didn't use insecticide-treated nets in hardly any homes. 
While we knew about indoor residual spraying, we weren't doing 
it. We didn't actually have ACTs to provide as the best drug. 
And we didn't have a good rapid diagnostic test which we have 
today. We actually have many of them today that we can take out 
into communities and know where malaria is. And as was 
mentioned earlier, we have cell phones that allow people to 
send text messages and either alert us of outbreaks or tell us 
about cases and their needs for the supplies that are so 
important. But that progress is incredibly fragile and while 
the speed of change is remarkable, if we let our guard down and 
stop the resource flow, the speed of reversion will be, I am 
afraid, in our face. So, as has been mentioned, this has been 
through bipartisan leadership in our country. It has actually 
been bipartisan leadership across the globe or multipartisan 
leadership across the globe it has been an incredible health 
success.
    And let me just highlight the Roll Back Malaria Partnership 
produced and launched just 2\1/2\ months ago this document on a 
decade of partnership and results in malaria control. And I 
refer the committee to this should there be additional 
questions about the extent and the numbers related to the 
success. We do this as people and the number of us have 
actually come down from the American Society of Tropical 
Medicine and Hygiene annual meeting being held in Philadelphia. 
That is actually a remarkable meeting. Many of the people there 
are malaria experts, certainly not all of them. A number of 
them work in other--particularly the neglected tropical 
diseases. But they provide huge leadership and have for a 
generation now and will continue to do so for subsequent 
generations.
    That leadership on the science side has finally turned to 
incredible success on the program side. And that is what makes 
me proud as a scientist, as somebody who cares about malaria 
and as an American citizen about our country's investment in 
this because I don't think there is any better. Thank you very 
much.
    [The prepared statement of Dr. Skeketee follows:]
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
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    Mr. Smith. Thank you very much, Doctor.
    Let me begin with the questions. And again, I want to thank 
all of you.
    Your full testimonies, without objection, will be made a 
part of the record, and they are very much filled with 
recommendations and good data that this subcommittee, and all 
interested parties here in Congress, ought to become very well 
acquainted with.
    Let me begin with Ambassador Green, if I could. You spoke 
of leadership, the importance of it, and others who might want 
to step in and speak to this as well, please do. How much U.S. 
funding is needed in the immediate term, this fiscal year, and 
going out into the near term, to ensure that there is no speed 
of reversion that I think we have to be very concerned about. 
We are in combat, as Dr. Rabinovich said, with the danger that 
this terrible parasite, as you put it, malaria, fights back and 
recent gains could be lost. I thought that was very telling and 
obviously very true.
    So if you could start with that. And secondly, Ambassador 
Green, you talked about the malaria early epidemic detection 
system. You talked about how MEEDs has been created and how 
well it worked. And I am wondering if this best practice is 
being replicated--and if anyone else would like to touch on it? 
Anywhere else, it seems to me when you prove something and 
prove it well, it ought to be rolled out as quickly as 
possible.
    Then you also spoke about the importance of faith-based 
collaboration, and I, too, believe that with the HIV/AIDS 
pandemic, without full cooperation with the faith-based 
community, particularly in Africa, where it represents 70 
percent of all health care that is delivered via a health care 
institution or clinic. To bypass that would mean that fewer 
people get antiretrovirals, in the case of HIV/AIDS, as well as 
testing and all the other important things. You highlighted how 
the Catholics and the Muslims are working so well together to 
train 300,000 imams, priests, pastors and ministers to carry 
out the malaria prevention message to villages throughout 
Nigeria.
    If you could maybe elaborate on that a bit, because it 
seems to me that is not only an important health care 
initiative but also mitigates some of the unnecessary and 
deleterious animosity between Muslims and Christians in 
Nigeria, where there has been a flare up, as we know, in recent 
months and years.
    Ambassador Green. Well, thank you, Mr. Chairman.
    I will attempt to partially duck the first two questions 
you asked, particularly with respect to funding. What I would 
rather do is defer to my colleagues. And Dr. Bowen can talk to 
you a bit about the state of funding and the funding request. 
What I can say is that what separates the malaria challenge and 
our approach to it from some of the other challenges and 
choices that, respectfully, you face and you face here in 
Congress is, again, we know precisely what to do; that this is 
a question of our willingness to invest the necessary 
resources. Again, technologies are fairly proven. It is a 
financial challenge and a challenge in our commitment and 
leadership.
    A name that has come up a couple of times in the testimony 
that I would commend to you is Rear Admiral Tim Ziemer, the 
head of the President's Malaria Initiative, who I believe is an 
outstanding leader in not just global health, but also in 
logistics. And what he can tell you is, take a look at the map 
of Africa and tell you in those countries in which PMI is 
operating, precisely what we--we being the world community--
will get for the investment of resources. In other words, you 
can boil down to the bed nets that can be purchased, the rounds 
of indoor residual spraying that can be purchased, precisely 
what we will be able to get with resources invested.
    He can also tell you geographically, and one of the things 
that I think is remarkable about his leadership is when he 
takes a look at that map, he is able to tell you precisely what 
we need to be able to go into certain countries and add them to 
the list of those nations that will see a reduction in malaria 
of 50 percent or more.
    And the same is true with respect to your second question. 
MEEDs was a project that was developed and piloted in 
cooperation between the President's Malaria Initiative, the 
country director, Dr. McElroy, working in Tanzania with public 
health leaders in Tanzania and Zanzibar, in particular. And it 
was launched just a couple of years ago but, again, has already 
shown remarkable progress. One thing you can count on from 
Admiral Ziemer is that he will, in fact, take and use those 
best practices and spread them wherever we can.
    One of the things that maybe--one of the reasons it was 
pioneered in Zanzibar--is because we had seen such progress 
down to the point of below 1 percent infection rate. And the 
question was, what does success look like? You know, when is it 
that we can say we have crossed the goal line. MEEDs is an 
effort to do just that. MEEDs is an effort to take the 
remarkable efforts that have been made, lock them in and to 
take those final steps to stamp out whatever, God willing, 
minor infection outbreaks that we see.
    With respect to the faith-based story, Nigeria in 
particular, but in other parts of Africa, it really is 
remarkable, just as you pointed to. It is remarkable for two 
reasons, or its advantages are really twofold. In terms of 
being able to deliver a product, I was always amazed as 
Ambassador when organizations from the West would come to me 
and talk about reaching out to other parts of the country and 
having no concept whatsoever about the logistical challenges 
that that presents. These are remote areas that are oftentimes 
completely cut off in terms of modern media access, in terms of 
the traditional infrastructure that, you know, we have become 
accustomed to. Faith leaders, of course, are well established 
in every corner of the land. So when you are able to enlist the 
armies of compassion that come from our faith leaders, you have 
a built-in distribution network that can move product very 
quickly.
    But the other part to it, that I really want to focus on, 
is faith leaders are able to pierce through the lack of 
education and knowledge that in some ways is the most daunting 
challenge that you face in some countries. When I taught school 
in Kenya, my students were absolutely convinced you got malaria 
from rain. And you could see how they would jump to that 
conclusion, and that would be relatively harmless, except if it 
comes from rain, why would you sleep under a bed net? So 
enlisting respected faith leaders, whose voice and opinion is 
held in high regard and trusted and listened to, they are able 
to pierce through that.
    I faced a similar situation last year when I went to 
Liberia, and part of the reason for that was with Malaria No 
More, where we did a focus group and asked young mothers why 
they didn't sleep under a bed net. And a lady said to me that 
she couldn't sleep under a bed net because at night when her 
spirit left her body and went out into the village, that if she 
slept under a bed net, it might not be able to come back. An 
American recovering politician can say over and over again, 
that is not what happens, and that of course is to no avail. 
But when the local faith leader comes and says, this is why we 
need to do this, that is the voice that makes a difference.
    The Nigeria story is the most remarkable in terms of 
numbers, and it really is a model to hold up as a success. And 
I think we all owe a debt of gratitude to the Center For 
Interfaith Action Against Global Poverty, another Gates funded 
institution, which has spearheaded this from our perspective. 
But the best news is it is not just confined to Nigeria. The 
story is in many other parts of the continent as well.
    Mr. Bowen. If I might just pick up on two points from 
Ambassador Green. First, very briefly, on the faith-based 
organizations. I, until quite recently, worked for the Gates 
Foundation. And one of my most memorable experiences there was 
traveling to northwest Nigeria and working with the sultan and 
the amirs. And I had the privilege of being able to address a 
meeting called by the amir of Gwandu in a room that felt like 
it was about 120 degrees, where the entire leadership from 
northwestern Nigeria was there. And when the amir said, you 
know, please cooperate with the polio vaccination campaign, 
that message went from the amir, to the district's head, to the 
village heads. It is an extraordinary reach. Just on the 
funding.
    We certainly strongly support the President's request of 
$691 million for PMI and $1.3 billion for the Global Fund. And 
the math here is grim, but inescapable. For every $50 million 
cut under the 2011 levels, that means a million fewer bed nets 
distributed and 2.5 million fewer combination therapies.
    Mr. Bate. I would concur with my panelists that the funding 
request from the PMI should indeed be met as best as possible. 
I think we also need to think tangentially about funding 
efforts that will improve malaria treatment.
    And so I will refer to the remarks I made before about 
USAID's funding of the U.S. Pharmacopeia project on quality 
medicines, an extremely important role in building up. They 
have the competence to help the medical regulator authorities 
in these countries that is very important to control for 
quality of drugs.
    Where I may part company is on the funding of the Global 
Fund. I think the Global Fund is a fantastic organization, but 
recently, the high level independent review panel recommended 
that the Global Fund--and I quote--``mandate the outsourcing of 
drug storage and delivery as the norm, except where the fund 
certifies a local institution according to international 
standards.'' At the Global Fund's 24th board meeting, it merely 
decided to give consideration to this recommendation rather 
than begin its implementation.
    In certain parts of Africa, where my colleagues and myself 
to a certain extent, have looked at the private sector ACTs 
markets. In one study we published in the peer-reviewed 
literature, 28 percent of the drugs on sale, the ACTs on sale 
in the private sector, were stolen and diverted from the public 
sector. That is because of poor management.
    Now, I think that the U.S. should be pressuring the Global 
Fund as far as it can to not only look into the recommendations 
of that high-level panel but actually enact them or perhaps 
potentially restrict the funding from the U.S. Government.
    Mr. Smith. Dr. Schmatz, you identified, as did other 
panelists, the growing threat of resistance to artemisinin as a 
key challenge to controlling malaria.
    Dr. Bate, you talked about monotherapies, and that 6 years 
ago the WHO demanded that manufacturers stop making and selling 
artemisinin monotherapies. And you point out that producers in 
China, India, and Vietnam in particular, ignored WHO policies 
and demands and continue manufacturing these drugs.
    And, Dr. Bowen, you also talk about drug quality in your 
testimony, and you note, I think, some progress being made. But 
what about those countries that continue? It seems to me that 
China, which increasingly is garnering the market on the 
manufacture of drugs of all types, you know, this could be a 
serious detrimental effect of trying to use the ACTs, as you 
talked about in your testimony? Why are the WHO policies being 
ignored and resisted by these manufacturing countries?
    Mr. Bate. The extremely good manufacturers in China and 
India and perhaps in Vietnam--I know them less well--are 
brilliant at getting their products into the market. And that 
is one of the reasons why there are so many different brands 
and so many good antimalarials out there. And that needs to be 
stressed. And I probably should have stressed that before.
    The problem that you identified correctly is that they are 
not adhering--some of the manufacturers are not adhering to 
that. The only immediate thing I can think of doing is to in 
every sense limit donor support for any manufacturer that is 
selling a monotherapy, even if it is also selling an ACT. So do 
not fund the ACTs from those manufacturers that still are in 
breach of the guidelines. That is the only short-run thing I 
can think of doing.
    Mr. Schmatz. One aspect of that that I think does work is 
that for the Global Fund and other donor organizations, in many 
cases, countries cannot buy drugs that are not pre-qualified by 
WHO. And so I think that is a really important standard to set 
and to stick with. I mean, not that you can totally enforce 
that everywhere. But the funding that is used from these donor 
organizations, if it can't be used for those other products, it 
won't be. And at least they will focus you toward the ones that 
are quality drugs.
    Our mandate in everything we do is to focus on quality 
drugs that are approved by rigorous regulatory agencies, like 
the FDA or the DMA, and all the things we are bringing forward 
in the future and make sure those quality standards are met and 
that again those drugs would be pre-qualified by the World 
Health Organization to be the ones that could be bought with 
those funds. It is much more difficult, of course, in country 
to deal with drugs coming from other sources.
    Mr. Bowen. And I would add just one comment which is that 
the ultimate response to resistance is really two-prong. One 
prong is to implement the safeguards that were identified 
against the use of counterfeit and substandard medications, but 
this is ultimately an arms race with the disease itself. And 
you can slow the pace of that through adequate controls, and we 
certainly should. But the other prong of the response is robust 
research and development so there is a constant stream of new 
approaches and new treatments.
    Ambassador Green. Mr. Chairman, just a couple of quick 
additional thoughts.
    You have put it the right way with respect to 
monotherapies, and that is focusing on the producers. Some 
might be tempted to ask, why can't we ban these in-country? Of 
course, the difficulty is if you are a poor family in Tanzania 
and you have access to a monotherapy of artemisinin, which you 
are told will, in fact, address malaria for you, although in 
the future, it may lead to resistance, but it is much less 
expensive; it is very difficult to expect that family not to 
take the less expensive drug because, of course, in so many 
cases, they have profound challenges of poverty. So you are 
focusing on this issue in the right way.
    Secondly, I would hearken back to ALMA, the African Leaders 
Malaria Alliance, and really the banding together of heads of 
state from all across Africa has been a remarkable development 
and I think offers great hope in this area. Dr. Bowen put up 
the scorecard.
    I have been very impressed with how strongly they have 
tried to share best practices and quite frankly hold themselves 
and their colleagues accountable for those standards. So, 
again, I think the emerging African leadership does offer some 
real hope in this area.
    Mr. Smith. Dr. Steketee, in your testimony you raise so 
many questions. You all do. Time does permit--we will submit a 
number of written questions for all of you. But, Dr. Steketee, 
you, in your Message No. 3, talk about prevention in pregnancy 
and you point out that coverage of women with intermittent 
preventive treatment for pregnant women has been slower and not 
as well supported as might have been possible. Efforts in this 
area need to be redoubled to protect susceptible women and 
their newborns. We all know that malaria contributes to 8-14 
percent of low birth weight in malaria endemic countries. 
Obviously, that decreases significantly the child's chances of 
survival. And I am wondering what your recommendations would be 
there. Is that something that from a policy point of view has 
not been emphasized?
    Dr. Steketee. Thank you very much for that question. I 
actually spent much of my science career looking at malaria and 
pregnancy and its prevention. It is interesting. This is 
actually a relatively easy and low-hanging fruit, and where 
people have paid attention to it, the programs have done quite 
well. That is, we have gotten both the insecticide-treated nets 
and the intermittent preventive treatment to those pregnant 
women.
    It is typically administered through existing antenatal 
clinics, and antenatal clinics actually are some of the best 
attended health facilities by the target population. So the 
women come, and one of the challenges has been that it has been 
just a little off the radar. It hasn't been quite as important 
as the insecticide-treated nets or indoor residual spraying. 
And everybody, of course, needs drugs to treat the acute 
infection. And it is relatively inexpensive because it is two 
doses, maybe three doses in the course of a pregnancy of 
sulfadoxine/pyrimethamine, which is one of our least expensive 
drugs out there. And we are looking for new drugs as well.
    But in the scheme of things, having said that, this was 
actually raised at the Gates Malaria Forum last month. And it 
was highlighted, and there is a process underway as we speak 
about looking at some of those policy issues and some of the 
performance issues in solving them, and experience says that 
they are relatively easily solved. It is just a bit more 
attention that needs to be paid.
    Mr. Smith. Dr. Rabinovich.
    Dr. Rabinovich. Yes, actually, tomorrow morning at 7 
o'clock o'clock in the morning, in Philadelphia, a meeting of 
the partners will occur because I think this one fell off the 
radar due to lack of attention. The drug is cheap. This is 
really doable. Prenatal care is happening. It should be 
delivered, and the resources exist because of the Global Fund 
and PMI funding in country. So we just need to make sure we pay 
attention, work with the leaders and hold ourselves 
accountable. And tomorrow morning we are on our way.
    Mr. Smith. Thank you.
    Mr. Schmatz. I just want to comment on the resistance 
question that you asked earlier, and that is I think one of the 
big problems we have with the current resistance we are 
starting to see in the ACTs now is the drugs that are--the 
combinations in those, those fixed-dose combination drugs, all 
of those components at one time were used as monotherapy well 
before the time when people decided--actually it was HIV that 
kind of led into the understanding that putting two different 
drugs and two different mechanisms together, you can delay 
resistance against both of them and extend the life of both of 
those drugs.
    We unfortunately didn't have that luxury in the malaria 
world because the ones we had available to do these 
combinations with had already been used quite frequently before 
that for many years as monotherapy, leading to resistance of 
both of them in the parasite population. So when you put them 
together, there is still that potential for that. The goal now 
going forward is the new drugs we develop need to be made as 
fixed-dosed combination immediately and never be sold and 
available as single entities. That would definitely extend the 
life of any of those new drugs that we develop going forward.
    Mr. Smith. Dr. Rabinovich, you mentioned that we are much 
closer to having a malaria vaccine that works through 
significant efforts by the Malaria Vaccine Initiative and many 
partners. You said it is possible that the malaria vaccine will 
be available by 2015. Now is that possible or probable? And how 
far are we in terms of--and, Dr. Bate, you talked about this 
and all of you did really--the whole resistance problem? At 
what point does our current ACT treatment, or whatever the best 
treatment is, become obsolete? We are in a race with time. How 
much of a race are we in?
    And finally, to Dr. Rabinovich, if I could, you said the 
Gates Foundation also invests in the development of new drugs 
and methods to control mosquitoes. The BBC in August--and I am 
sure you all saw it--did an article about a spermless mosquito 
holding the promise to stop malaria. And, of course, it talked 
about developing 10,000 mosquito embryos with tiny fragments of 
RNA designed to turn off the gene that is essential for normal 
sperm development in mosquitoes. Is this something that is 
promising? Do we give much weight to this as a way of 
controlling the very population of mosquitoes?
    Dr. Rabinovich. Thank you for those questions. Let me take 
them one at a time. The first question you asked is about a 
vaccine. And the results that were published in October are the 
preliminary results, just the 1-year result of the RTS,S 
vaccine, which has been tested in--at 11 sites, 7 countries in 
Africa. That trial is ongoing. And I think for full 
transparency, the first year results were presented. But really 
we need the full results, not only from the toddlers but from 
the babies that were just recruited. And we are going to have 
those results able to look at in 2014. Now, it needs to be 
evidenced-based. If it works and it protects children for a 
number of years, we want to make sure there is no rebound. It 
is something that the advisory committees, the WHO and the 
countries will consider for use.
    But it is not a perfect vaccine. The evidence so far is 
that it is about 50, 55 percent efficacious at preventing 
malaria and preventing clinical illness from malaria. So we are 
going to have figure out how that compares and how it adds to 
bed nets and to the other measures that are available when 
those data are available. So the story still is still to be 
told, but it is the first time that we have really shown in a 
large enough population is that you can have an impact with a 
vaccine.
    The second question you asked was about resistance. And the 
place where resistance has been shown has not been in Africa. 
We are all scared to death that it will actually move over to 
Africa. Historically, resistance for reasons that are not 
totally clear to us I think have begun in Vietnam, Thailand, 
Cambodia and Asia and then migrated over to India and then 
hopped right over into Africa. It was recognized by planned 
studies looking for resistance. These have to be small piloted 
studies to evaluate how well the drugs are working, recognized 
along the Thai-Cambodia border. And the partners of bilaterals 
have gotten together to actually work to decrease the amount of 
malaria there, ideally eliminate it, because of fear it would 
move onward, and that really is a global crisis if it did. We 
would lose ACTs.
    We are very excited about the portfolio that sits at MMV. 
You call it OS. I call it ``Oz'' because it would really be a 
wonderful thing to have. But they are not available yet, and so 
we really have to pay attention to resist intense ACTs today. 
The third thing you asked was about mosquitoes. And I think it 
is important to consider innovation, not only in new drugs and 
vaccines but also in ways to control mosquitoes, because we 
know that bed nets right now--bed nets and indoor residual 
spraying are at the core of our impact in Africa today. And 
there are several approaches.
    The one that you refer to is they have genetically modified 
the mosquito so that it cannot be reproduced. That is one idea 
that is being tested.
    Another is to have ways of having a Wolbachia, which is 
actually an infection within the mosquito that requires to 
attack it through Wolbachia-based approaches. There may be 
other innovative approaches, not just insecticides that would 
ultimately help us in the fight of decreasing the risk of 
getting bit by an infected mosquito.
    And all I can say is we need to look at their safety. We 
need to make sure that they work and then evaluate them to see 
which one gets introduced. And there will be concerns in the 
global stage about genetically modified organisms, and I think 
that is why I am saying that the data needs to drive their full 
evaluation for inclusion in the global program.
    Thank you.
    Mr. Smith. Yes, Dr. Bate.
    Mr. Bate. Just one point on the research agenda. Although 
this is a hearing primarily about treatment, I think it is 
somewhat worrying that only about 4 percent of the global 
malaria budget is spent on areas of insecticide research. And 
regardless of whether it is indoor residual spraying or bed 
nets, we are going to need better insecticides, and with the 
exception of the Gates Foundation, which funds the IVCC, there 
is very little effort in that area.
    It is probably more contentious and people don't like 
insecticides. But I think that is going to be an area in the 
short run that needs to be ramped up because until we have--
this is not to downplay the vaccine. I think it would be 
fabulous. Until we have a much more effective vaccine, then I 
think we are going to continue to need insecticides and new 
ones at that.
    Mr. Smith. Just one last question before yielding to my 
friend, Mr. Payne. With regards to vector control, which Dr. 
Steketee also spoke about in his testimony, are malaria-bearing 
mosquitoes spreading, despite all of our efforts? Obviously, 
bed nets protect individuals during the most fearful times, at 
night, during sleep, when children and adults could get bit. 
But are the mosquitoes that bear and carry malaria spreading in 
their borders? I chair the Lyme Disease Caucus here in the 
United States Congress, and we know that the Lyme disease-
bearing tick, particularly the deer tick, just every year 
expands, and, unfortunately, mal-affects people with disease. 
Should Americans be concerned that malaria has come to our 
shores, for example, from countries that are in Africa and 
other endemic areas?
    Dr. Steketee. Thank you very much for that question. You 
also raise the issue of borders and which becomes an 
interesting thing. This is--and I just highlight this because I 
think one of the potential progresses here and particularly 
with ALMA, the idea of African leaders actually banding 
together for leadership purposes and allowing them to cross 
their own borders with the right ideas. So I just put that 
aside as really a critical issue.
    Most mosquitoes actually would like to move as little as 
possible. It is a pretty tough life out there for them. It is a 
fragile little woman mosquito, because those are the ones we 
care about. She would like to go and find a very close body of 
water to lay her eggs in and then return to the house where she 
came from. So she has very little incentive to go across 
borders. So, for the most part, the mosquito itself will not be 
the big transmitter going across the borders.
    It is actually us people that move the parasite and make us 
concerned about that.
    Having said that, we think of populations of mosquitoes. 
And if you have a very good intervention, which we do with 
insecticide-treated nets and indoor residual spraying, that 
intervention has been shown to essentially kill all of that 
population that have the particular behavior of feeding indoors 
and on those people sleeping at night and essentially kills all 
of those. Now there may be in the midsts of that population a 
few that didn't read the textbook, and they go out, and they 
bite somebody outside, and they get their blood meal and they 
are able to continue, and they stay outside of that immediately 
targeted area of insecticide. So we end up with actually an 
evolving population because of how good our intervention is. We 
have left remaining those few that don't have that behavior, 
and they start to look like we have created the wrong thing, 
that is we now have allowed them to survive, but we have killed 
all the others. Mind you, those are the ones that are a little 
less likely to bite indoors, and they are a little less likely 
to transmit ongoing. So they actually become a weaker and 
weaker transmission for the malaria. We may need to go after 
those.
    And as insecticide resistance evolves in a population, it 
evolves because we are using just one, and we are learning to 
do and discussing, and it is going on again as we speak, there 
is a--WHO has produced a draft document for controlling 
insecticide resistance, which includes the idea of rotating, 
which is a lot like using combination therapy for drugs, but of 
rotating insecticides so that we are not allowing a population 
of resistant mosquitoes to evolve.
    So I think there is actually a lot of work being done on 
that. And as long as we don't lose sight, and I will highlight 
the idea that research ongoing on insecticide is actually 
critical in the midst of this. We do need that.
    Mr. Smith. Thank you.
    Dr. Bowen, did you want to comment?
    Mr. Bowen. Just one very brief comment. A lot of the 
previous comments have focused on sort of the high-tech methods 
for mosquito control, and those are all very, very important 
but there is a lot of low-tech work that can be done. For 
example, we are working with an organization in Senegal with a 
French acronym of PECADOM, which trains people to be community 
leaders and just do very simple things to stop mosquitoes from 
breeding; making sure that there aren't tires lying around that 
can serve as pools of standing water and that sort of thing. So 
it really is a partnership of both the very high tech, the 
transgenic mosquitoes, with the very low tech of just making 
sure there aren't tires lying around in the village.
    Mr. Smith. Mr. Payne.
    Mr. Payne. Thank you very much.
    It is a very in-depth discussion.
    According to WHO--and anyone can answer--insecticide-
treated nets that were distributed between 2007 and 2008 need 
to be replaced. What steps does your organization take to 
ensure that the nets will be replaced as needed? And in your 
opinion, what steps should the donor community take to ensure 
that the nets are replaced? And also if you could even, 
preceding that question, there was always some question about 
the treated nets, and there was, I think, initial opposition in 
some countries. Could you tell me how that has been overcome? I 
suppose it has been. But do you still find some resistance to 
that? And secondly, how do you keep a count of the replacement 
needs for the nets after several years of use?
    Dr. Steketee. Let me take that question on. We have 
actually worked with a number of countries now in that process, 
and this is where the country logistic systems have really 
dramatically changed in the last few years. I would say that 
from 2005 to 2007, we had a hard time understanding exactly 
where the nets were needed, where they were, where they weren't 
and how to understand when to replace them.
    We have now gotten to the point where almost village by 
village in many countries, they have a roster of nets in 
households, which ones are short of nets, which ones are--ways 
of measuring--picking up on who lost a net, maybe it burned 
last night under the stove for the kitchen; maybe it is just 
now torn too much and registering its loss. So the systems are 
categorically better. For example, we have been working in 
Zambia a lot. Zambia has district-by-district, regularly-
updated numbers as to how many nets they have in stock, how 
many nets are in households, how many they anticipate needing 
to replace in the coming year and what the resources are.
    I will just highlight one challenge in the midst of that, 
and that is, unfortunately, the ups and downs of funding that 
determine that tranche of insecticide-treated nets comes to the 
country. If the country doesn't have the money to procure, they 
hold off. And because this is so seasonally tied in many 
places, if you miss one season, you allow your entire 
population to just be inadequately protected for that season.
    So one of the challenges for the countries has been to take 
that information and to try to match it with some consistent 
funding so that they have supplies when they need them.
    Mr. Payne. Thank you very much.
    So the question, just listening to your answer, really has 
a lot to do with the manner in which the individual countries 
have worked on their health systems, delivery systems and--how 
have your--any of your organizations worked with the basic 
things that you mentioned, keeping inventory, making sure that 
people know that a program is going to start? Are there any 
programs--I am sure you do have that--that go into communities 
to build that kind of very basic infrastructure up?
    Mr. Bowen. One of the areas that we are working in is--
again, innovation doesn't just happen in the lab. We are trying 
to find innovative ways to communicate with communities, and 
having cell phone technology and other kind of mass media to 
let people know about the need to use bed nets properly is 
another way to just make sure that families are using the bed 
nets every night and are using them adequately. And I am sure 
others can comment on some other things that are being done to 
build up the health systems.
    But also, I think your question highlights the fact that 
ongoing funding really is needed because it is not adequate 
simply to buy one tranche of bed nets, as you pointed out. 
There is an ongoing need to replace as they get worn and as the 
long-lasting insecticide ultimately wears out.
    Ambassador Green. I think, first off, the most important 
thing to remember is that no program, no plan will be 
successful if it isn't a partnership between donors and leaders 
in-country.
    I mean, I think a basic rule is you can't want it more than 
they do. In other words, these programs have to be built around 
in-country, innovative leadership that is committed, top to 
bottom, to getting this done. And when I do take a look at 
those countries where the success has taken place, those are 
the countries.
    In Tanzania, when President Kikwete talks publicly about 
sleeping under a bed net himself, when he takes to the stage at 
concerts with malaria messages, when that kind of leadership is 
shown and when clear signals are sent throughout the ministry 
of health and leadership all over the country, where faith 
leaders are enlisted, that is where success takes place.
    Also, in terms of our response to malaria interventions, I 
think a very innovative program that really hasn't gotten 
enough attention is the involvement of the Peace Corps. Peace 
Corps volunteers--in some ways, this was pioneered in Senegal, 
and Malaria No More played a huge role in that. Peace Corps 
volunteers have been very effective in using the typical 
volunteer's ingenuity and sense of can-do in malaria messaging, 
in working with leaders, in keeping track on the logistics 
front. So it is partnerships across borders and across oceans, 
and it is partnerships across cultural sectors inside the 
country that is making the difference.
    Mr. Payne. There is the debate I think in the millennium 
development goals on the question of control versus 
elimination. And when we get into, you know, limited funding, 
especially now that we understand that the Global Health Fund, 
a number in Spain and Italy, some are going to be unable to 
reach their goals because of their financial situation. We have 
the two to one--and by us actually reducing our appropriations 
proposal, we restrict how much the others can give. How do you 
see this--us being able to kind of get through with the 
combination of the European problem and the possibility for the 
Global Fund in particular of the cut in funding?
    Dr. Rabinovich. I think there are a number of things that 
can be done and are being done. The first is to look for 
efficiencies in countries, and the Global Fund has prioritized 
this and they call it value for money. But it is actually 
looking for the most efficient way to use the dollars and to 
make sure that you are getting the impact that you want. The 
second is--and I think was announced at the Global Fund board a 
couple of weeks ago, which is to focus on the most fragile 
countries so that lower-middle-income countries are no longer--
or fewer of them are receiving funding; Brazil offered not to 
receive funding, China will not receive funding--allowing them 
to focus on the poorest countries that actually don't have a 
lot of alternative ways of funding the sustainability of bed 
nets and of treatment. I think those things go part of the way 
toward dealing with the temporary gap in any single country to 
give. But I think we have to look at the bigger picture, given 
the impact not only on malaria, but HIV and TB, that this is a 
priority program that has really been recognized for its 
effectiveness and for its impact and to figure out how to 
sustain it for the longer term. And I think that must be a 
priority.
    Mr. Payne. Yes.
    Mr. Bate. Looking whether it is nets or spraying or 
treatment, it is a bit like removing garage; it is only 
sustainable if it is paid for. And the real question is how it 
is paid for. And whilst I actually do concur with nearly every 
remark that has been made in answer to these questions, I do 
think there are some African countries that are in a parlous 
state and really not that able to contribute as much. But some 
of the countries have significant wealth and have significant 
corruption problems. Maybe we have an opportunity here--I am 
thinking of Nigeria and Angola with their considerable oil 
wealth--to step up a little more than is currently the 
situation.
    That is not to deny that there aren't major problems and 
that the aid community should not do what it can. But given 
strained conditions, these may be opportunities to press harder 
for the nations most affected to step up a little more 
themselves.
    Mr. Payne. Yes, Dr. Bowen.
    Mr. Bowen. Just to pick up briefly on that. There clearly 
is a great need for financial transparency. That is why one of 
the things that ALMA is doing, the measures are not just about 
public health measures. They are things like financial 
transparency, removal of tariffs on antimalarial goods and 
preventive bed nets and products such as that. So I couldn't be 
more supportive of Ambassador Green's comments about the 
leadership of President Kikwete, and we are delighted that 
Ellen Johnson Sirleaf is coming in as the leader of ALMA.
    And I would also agree with Dr. Rabinovich's comments, that 
it is important to get the most--to squeeze the most valuable 
for money out of every dollar, euro, yen that goes into the 
Global Fund. But ultimately, of course, the United States is 
the indispensable nation in this. If the United States isn't 
there, the effort there will be significantly imperiled.
    Ambassador Green. If I can, just a couple of thoughts I 
think are important to put on the record. Remember, this 
challenge is unlike some of the other development challenges 
that we are taking on. Half measures don't work. This is not a 
situation where you can extend out, you know, filling the jar 
with pebbles over more years. There really is a premium on the 
mobilization of resources. You either do it, or you don't do 
it. But sort of crawling along slowly, you won't get the return 
on investment.
    One of the remarkable things about the malaria challenge 
is, again, we know what to do. And in Zanzibar and other parts 
of the world, there is clear evidence of that. And one of the 
things that we have learned is an integrated mobilization of 
resources is what makes the difference. And so one of the 
things I admire about what PMI is doing is when they take a 
look at those countries, they can go into, they don't simply 
take their resources and divide it up by 50. They instead look 
and say, okay, here is leadership; here is a definable 
challenge. You know, we look at the math. We can do this. Let's 
do it.
    And what that means in some cases is there are terribly 
impoverished countries where there are huge problems that we 
would like to go into and try to make a difference, but we are 
resource constrained. There are other countries that we look at 
and perhaps they aren't as poor, but we look and we say, okay, 
we can do this, you know, we can defeat this here. And as you 
take a look at the overall challenge, those are the choices you 
have to make. But it is important that we understand you have 
got to mobilize, you have got to mobilize fully, you can't 
simply extend this out and go on the cheap. If you do, sadly, 
we won't get there. We won't be able to fill the promise.
    Mr. Payne. With the new ALMA project that you mentioned--
and I was very impressed with just looking at the schematic 
there--how long have they been putting out that report that 
complicated--I mean, that thorough?
    Mr. Bowen. This is the initial scorecard, but the plan is 
to keep it going and to use this as a touchstone for 
responsibility for accountability in the fight.
    Mr. Payne. I think that measures like that--NEPAD was 
supposed to be a move in that direction, and it has kind of had 
some stumbling blocks. But I think that once nations are held 
accountable, that they are compared to others--I think what Mo 
Ibrahim is doing with his whole question of rating, you know, 
heads of state I think is really putting the spotlight on, and 
I do believe that we will get to the point where, you know, 15, 
10 years ago, people didn't even discuss corruption and these 
things that had been going on, you know, for decades.
    And of course, we also have to work more on the European 
countries. As many of you may know, the corruption has not been 
illegal in most of those countries, and as a matter of fact, I 
think it was in Germany, you could make it a tax deductible 
item; you just had to declare it. But it was not--it was not 
considered criminal. It was considered the cost of doing 
business. So if we can work more on the corrupters, you know, 
it is a two-way street, it doesn't condone those who take 
corruption, but I think that those who are offering it and like 
I said, I travelled in Africa for decades and decades, and it 
seemed like a practice that was just a part of a business 
portfolio for a number of the European countries. So I think 
that it is a two-way fight. We have got to continue to work in 
exposing it, having reporting, have things that are verifiable, 
having things that are out in the public so that people can be 
judged on what they do or do not do.
    Just lastly, how rife as a problem is the sale of 
counterfeited or adulterated or poor quality drugs? Do we have 
any fix on that? Is there anyone who is really monitoring that? 
Do we really know how bad it is.
    Mr. Bate. Yes. The short answer is, no, we don't have a 
good handle on the size of the problem. A lot of the data that 
has been collected is not easily comparable. There is no doubt 
that there is a significant both substandard and falsified drug 
problem, products which are either intentionally there to 
mislead people or, more likely I think in the poorest countries 
in Africa, drugs which have been made legally but are just not 
up to the standards. And also, in addition to that, you have a 
problem with storage, transportation, which leads to 
degradation of products.
    So it depends how you define it as to the numbers you get, 
but most of the studies that have been published which do any 
level of comparison from one location to another, follow 
reasonably tight protocols, you are seeing at least 10 percent 
of the products failing in quality control. And in some markets 
for some drugs and antimalarials, it is considerably higher 
than that, but we don't really have a good handle on the exact 
numbers.
    Mr. Payne. Yes, Doctor.
    Dr. Rabinovich. If I could give you an example from the 
diagnostic field, we funded the Foundation For Innovative New 
Diagnostics to work with WHO to evaluate how good were the 
diagnostics. And of the first more than 100 diagnostics, only 
about a third were working the way that they should.
    Now that information was fed back to the Global Fund and 
PMI and other funders so that they focused on the use of good 
diagnostics which then becomes the basis for credible diagnosis 
at the field level which is necessary for adequate and 
appropriate use of drugs. But it is these quality systems, not 
only for--I mean, the same thing can be said for vector control 
tools. Do they really have an insecticide that will really 
least 3 or 4 or whatever the advertised number of years? These 
regulatory systems and validation systems are really important 
to the ongoing credibility of the program and really needs to 
be part of what is maintained.
    Mr. Payne. Well, let me thank you very much. We will 
certainly continue to focus on this issue. Actually, Thursday 
of this week we are going to be cohosting an event with PATH 
and Roll Back Malaria, where the whole question of RTS,S, the 
discussion about malaria vaccination that continues on and was 
really at the 15th anniversary celebration of IABI, where Mr. 
Gates and some of his folks were about a month ago--where the 
whole question, as you may you recall, dealing with the 
vaccine, I think that is the goal that we really need to 
continue to move forward on, and then we won't have the debate, 
the question that I almost asked about, you know, should we 
spend money on trying to prevent, or should we put it on 
research? We get a vaccine, and we don't have to worry about 
it. So, once again, let me thank you all, and I yield back to 
the chairman.
    Mr. Smith. Thank you very much, Mr. Payne.
    Just a few follow-up questions and final questions if I 
could.
    Dr. Schmatz, could you discuss more the single-dose cure 
for malaria that was in your testimony that is in development? 
How long are the clinical trial phases?
    Mr. Schmatz. Currently in phase 2A, getting prepared to do 
bigger trials now. And the projection is that if everything 
goes smooth, which in our discovery that is not always the 
case, but we are very hopeful here from what we are seeing, 
that that product could be potentially available around 2016, 
going through all the steps along the way in the regulatory 
process and pulling all the stops out as well to get there.
    Mr. Smith. Let me ask Dr. Steketee, you in your testimony 
point out that four countries over the past 4 years--United 
Arab Emirates, Morocco, Turkmenistan, and Armenia--certified by 
WHO as having eliminated malaria, are the first countries to 
achieve this distinction in 20 years. Are there other nations 
that may be getting close to that distinction? Are any of those 
nations in sub-Saharan Africa? And if anyone would like to talk 
about this, which countries in Africa--and I know Dr. Bowen, 
you did raise up a very detailed chart, which I will read very 
carefully later, as I am sure others will--but which countries 
are doing the best across the whole broad range of strategies 
to combat malaria and who are the laggards? Dr. Steketee?
    Dr. Steketee. Well, thanks very much. Because this issue of 
eliminating malaria is obviously where many, many nations have 
put that in their current plans, that is what they are wanting 
to do. In the discussions that led to the updated Roll Back 
Malaria goals for 10 countries to eliminate in the coming 5 
years, they actually did that because there are nine countries 
that are in the WHO European region--this is not only Western 
Europe. This is a set of relatively small countries that have 
almost no malaria, but they have little pockets of it. And 
those are slated within the next 5 years to hopefully eliminate 
malaria. Armenia was actually part of that group and just 
declared elimination 2 months ago. So, yes, there are a number 
of countries in that stage.
    In terms of other places, you ask specifically about 
Africa, as Ambassador Green has mentioned, a small part of 
Tanzania, that is the islands off the coast, are actually not 
very far away. And this is the case of making a decision, do 
you go for it, and when do you go for it? In that sort of sub-
national setting, but because they are islands, clearing 
islands tends to be both easier and something that you can 
continue to sustain.
    Now among the other places in sub-Saharan Africa, first of 
all, South Africa still has transmission, but in focal areas 
along its boarders with Zimbabwe and Swaziland and Mozambique. 
And that is a lot because, not the mosquitoes moving across the 
border, but people move across those borders. And they are in 
particular trying to pay attention to whether or not they can 
eliminate it. And this is actually a pretty important 
discussion because that southern cone of Africa--Botswana, 
Namibia, Zimbabwe--once it gets beyond its political strife, 
has an incredibly strong health system, or did, and it has been 
hampered in the recent years, particularly from the political 
strife, but that could turn around. And if that does, you could 
have Namibia, Botswana, Zimbabwe, South Africa, and Swaziland 
actually quite close to eliminating malaria.
    Just north of that, I mentioned we had worked a fair amount 
in Zambia. There are parts of Zambia where you can now count 
cases in districts on hands and maybe hands and toes, and that 
is new. And that is why I am talking about the speed of change 
here and the innovation has gotten us thinking and gotten 
countries talking about what it takes to do elimination.
    The other places in sub-Saharan Africa are in West Africa. 
Particularly Senegal and Gambia have recently shown remarkable 
progress. Northern Senegal has districts where over the past 
year they have had trouble finding any malaria. So this 
elimination happens in these countries step by step, district 
by district, but both Senegal and Gambia are now meeting and 
talking about how they can work both across their boards and 
jointly against the parasite.
    And lastly, I will mention, outside of Africa, in the 
Americas, we have--the Americas have made incredible progress. 
And if you look country by country, particularly in Central 
America, but also in South America, they are not very far away. 
We are talking about a few deaths left. Just as an aside, 
Mexico is a huge place for U.S., you know, visitors to go on 
holiday. And we used to identify that we would recommend from 
the U.S. that our citizens take prophylaxis when they go to 
Mexico, and that was actually the largest number of use of 
prophylaxis for the citizens of our country. And that malaria 
in Mexico is almost gone.
    So the progress and the possibilities out there are really 
exciting, and they take attention, but that group of South 
American countries, they formed a coalition to try to do this, 
and they are close. And whether it is just moral support and 
applause from the sidelines or ways of figuring out how to 
emphasize that would be hugely helpful.
    Lastly, out in, again, back to the island issue in the 
Western Pacific, there are a number of islands that are working 
toward elimination. So while we haven't called those countries 
out for the next 5 years, it is--this is what is in abeyance 
here, that is if the global community backs off of malaria as a 
priority, then you can imagine that these places will say, hmm, 
not sure where the help is coming from and maybe we have to go 
do something different now.
    Mr. Smith. Thank you very much for that very extensive 
answer.
    We have talked a lot today about the importance and 
efficaciousness of insecticide-treated bed nets, indoor 
residual spraying and intermittent preventive treatment for 
pregnant women, three of the best tools that we have for 
prevention.
    And I am reminded, Dr. Steketee, that you mentioned earlier 
that the treated bed nets actually help kill the mosquitoes, 
which I think is a very important point to underscore. It 
reminds me in the whole fight against the pandemic of HIV/AIDS 
that antiretrovirals, ARVs, actually have capability of 
reducing the viral load, which becomes a way of defeating that 
terrible virus. Here we are defeating the actual parasite and 
the carrier of parasite.
    But let me ask anyone who would like to answer this, how 
and by whom are decisions made regarding what prevention 
strategies to promote in any particular region or country or 
even a specific area within that country? Who makes those 
decisions right now? Is it the Health Department? Is it the 
collaboration of the partners, or what?
    Dr. Rabinovich. I think any of us could answer. There is a 
global process, and WHO is entrusted with technical assessment 
of the data and making policy recommendations for the 
countries. But then there are regional WHO offices. And the 
responsibility really sits with the country to figure out how 
it is and what it is going to implement.
    And there are differences. Malaria is not a single disease. 
It demonstrates and has different patterns of transmission and 
different things that must be emphasized in different places. 
Trying to segment that into a pattern that would be easier to 
attack is something WHO is doing.
    But it really is a partnership between the many partners, 
including WHO, the Roll Back Malaria Partnership, which brings 
everyone to the table, and most important of all is the 
countries, because that is where the key decisions, not only at 
the national level but down to the district level, must be 
made. I don't know if anyone has anything to add. It is a 
little complicated, but it works.
    Dr. Steketee. I will just add this as an example where the 
U.S. President's Malaria Initiative sits with the country, 
country by country where they work and look at their plans and 
then look to see how they can help support the implementation 
of those plans. And it has been that set of years actually 
where there was very little money where people spent a lot of 
time figuring what the strategy should be that got us a solid 
set of national programs that could speak to this is our 
strategy.
    And then those evolve over time as we get new information. 
And so, for example, if we got a new vaccine or if we got a new 
drug that was a single-dose therapy with high cure rates, those 
would be rapidly discussed at WHO. And they would be rapidly 
discussed with the regional offices and then country by 
country. And experience has shown that we now have enough 
people with enough knowledge at country level that the uptake 
of that information is both thoughtful and relatively 
expeditious. 
    Mr. Schmatz. If I could add to that, the immediate approach 
and reaction to dealing with malaria is procurement, optimizing 
the current interventions you have, and in-country activities, 
and all of those are critical and have made a huge impact 
already. The long gain is clearly going to come from R&D. And 
when you look at the actual investment that is made in R&D, it 
is a long sustained expensive process. But I would argue, and I 
think most of the people in the room would agree with me, 
without that, the end game--you won't win the end game. So 
while the immediate interventions are critical, you are saving 
lives today with the tools you have now; you won't win that 
long game without sustained effort to really support the R&D 
that is out there. That is a very small component of the 
investment that is made today on the actual R&D part.
    Mr. Smith. I just want to note for the record, and mention 
was made of the $691 million request for Fiscal Year 2012. But 
in 2004, it was $89 million; 2005, $99.9 million up to $111 
million; in 2007, $256 million; $358 million in 2008; $391 
million in 2009; and it went up rather significantly in 2010 to 
$594 million. So the glide slope is a build out that needs to 
be sustained, and I think all of you have made your cases 
extremely persuasively, backed by your knowledge and your 
expertise, and very, very important information.
    I have a final question, and Mr. Payne may have a final 
question as well.
    Ambassador Green, again getting back to your original point 
about leadership and the importance of it, you did talk about 
how Coca-Cola is partnering with the Global Fund on a technical 
assistance project with regards to supply chains. I would note 
parenthetically that I travel often to Africa and elsewhere 
often to places that are way out of the way. All of you do even 
more so, I am sure. I am always amazed because once I am jet 
lagged by day 2, I drink a Coca-Cola for breakfast, and there 
is always one available at the hotel wherever I may be. So 
their supply chain is second to none. Could you elaborate on 
how well that is working and whether or not that expertise will 
be shared as a best practice for others?
    Ambassador Green. Yes, it is quite extraordinary, you can 
get a Coca-Cola just about anywhere in the world and certainly 
all over Africa. The early returns are good. But I want to 
build on that, and it is not just Coca-Cola. I want to point 
out another remarkable project that is current currently run by 
Barbara Bush, President George W. Bush's daughter, in which she 
came up with the idea, gee, we have lots of business expertise 
here in the U.S. and we have lots of young business executives 
who are dedicated to changing the world, so we have got 
expertise, we have got challenges, what do we do? And the 
Global Health Fellows, which is the name of her organization, 
matches up young business executives with development 
opportunities overseas.
    On Zanzibar, a young executive from The Gap spent a year 
helping the ministry of health in Zanzibar doing supply chain 
management on meds and was able to put his expertise and 
experience to work in remarkable ways. So have you Coca-Cola, 
which is doing things on a grand scale, and you have young 
entrepreneurs, business executives, doing it on a microscale. 
And the combination of those is truly uplifting. Because at the 
end of the day, it is going to be leadership. It is going to be 
that can-do sense that I think we are all very proud of, and 
that will make all the difference. Thank you.
    Mr. Smith. Thank you.
    Mr. Payne.
    Mr. Payne. Just that I really appreciate the fine work that 
all of you do.
    I agree that it is the will of the individual country and 
the community. About 3 or 4 years ago, I went to Rwanda, where 
they were starting this big initiative, maybe 2 years ago, and 
they started in the churches and in the community centers. And 
they had someone discussing it every week that this event was 
going to start. I happened to be there when we were out in a 
village where they were starting. Everyone had to take their 
furniture out of the house. They had to put their curtains up. 
I put on a suit. They thought I was a guy that had the job, but 
they were worried because they knew a local guy was supposed to 
do the job, so they thought I came and bumped him out or 
something. But I put on my suit, and we did the spraying around 
the house, and it was just like a community event. Everybody 
was involved. They knew what was going on. They were alerted. 
They knew when they had to have things out. They knew how long 
it had to be, have the kids out while the spraying went on. 
They put the nets up, and so I think it is very important how 
we work on the very local communities.
    One other issue that shows how I think it is catching on, I 
was in Djibouti at a military installation and there was a 
border dispute with the other country--I won't mention because 
they deny there was a border dispute. But there were 21 
prisoners of war from the opposite country. And I wanted to 
meet them to see how they were being treated, and they were all 
being treated okay, well and so forth, and we had a 
conversation with them. But the thing that was most impressive 
is when I went into their housing facility, lo and behold, they 
had bed nets. And that really said something, that they, in 
Djibouti, the government felt it was important enough to have 
bed nets around prisoners of war. You know, then, they thought 
this was an important issue. Same way in Rwanda where we have 
seen--I have talked to Ray Chambers. As I mentioned he is from 
Newark, New Jersey, and he talks about going to some of those 
pediatric wards and infant--in Rwanda where they used to be 
packed with kids, and now they have virtually no one there, 
which shows that in certain parts, it is really working.
    So what you are doing is fantastic and I commend the 
chairman for having this very important hearing, and we will 
keep pushing for elimination with the vaccine. Thank you very 
much.
    Mr. Smith. Would any of you like to make a final comment? 
You have been very gracious with your time. This couldn't come 
at a more timely period during consideration of the 2012 
budget, so thank you for that.
    Yes, Dr. Rabinovich.
    Dr. Rabinovich. On behalf of this group, I would like to 
thank you for holding this session. We are but a fraction of 
the partners that are involved in this. And as I think about 
the Rotarians in Zambia, the Methodists as principal; recipient 
of the Global Fund Award, Exxon Mobil talking about malaria at 
the Olympics, Nothing But Nets bringing in every sport that has 
a net of any kind into the fight. Under the partnership model, 
this has really been already an incredible decade, but there is 
really so much more that needs to be done over the next decade. 
When I visited the Gambia 10 years ago, there were three 
children to a bed for a disease that has almost disappeared 
from the Gambia 10 years later. This is possible. This is 
possible, but it really takes that kind of partnership, 
commitment, and steadfast attention to make it happen. Thank 
you.
    Mr. Smith. On that final very wise note, the hearing is 
adjourned.
    [Whereupon, at 5:23 p.m., the subcommittee was adjourned.]
                                     

                                     

                            A P P E N D I X

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     Material Submitted for the Hearing RecordNotice deg.




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Material submitted for the record by Mr. Roger Bate, Legatum Fellow in 
            Global Prosperity, American Enterprise Institute














                                 
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