    [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:]

                                  ----------

        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:]

                                  ----------

        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:]

                                  ----------

        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:]

                                  ----------

        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:]

                                  ----------

        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