    [Senate Hearing 108-848]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 108-848

      NEGLECTED DISEASES IN EAST ASIA: ARE PUBLIC HEALTH PROGRAMS WORKING?

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

                                    HEARING

                                   BEFORE THE

                           SUBCOMMITTEE ON EAST ASIAN
                              AND PACIFIC AFFAIRS

                                     OF THE

                         COMMITTEE ON FOREIGN RELATIONS
                              UNITED STATES SENATE

                          ONE HUNDRED EIGHTH CONGRESS

                                 SECOND SESSION

                                   __________

                                OCTOBER 6, 2004

                                   __________

           Printed for the use of the Committee on Foreign Relations

     Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                     senate

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                         COMMITTEE ON FOREIGN RELATIONS

                      RICHARD G. LUGAR, Indiana, Chairman

    CHUCK HAGEL, Nebraska                JOSEPH R. BIDEN, Jr., Delaware
    LINCOLN CHAFEE, Rhode Island         PAUL S. SARBANES, Maryland
    GEORGE ALLEN, Virginia               CHRISTOPHER J. DODD, Connecticut
    NORM COLEMAN, Minnesota              JOHN F. KERRY, Massachusetts
    GEORGE V. VOINOVICH, Ohio            RUSSELL D. FEINGOLD, Wisconsin
    LAMAR ALEXANDER, Tennessee           BARBARA BOXER, California
    JOHN E. SUNUNU, New Hampshire        BILL NELSON, Florida
    LISA MURKOWSKI, Alaska               BARACK OBAMA, Illinois
    MEL MARTINEZ, Florida
                     Kenneth A. Myers, Jr., Staff Director
                  Antony J. Blinken, Democratic Staff Director

                                     ------

                           SUBCOMMITTEE ON EAST ASIAN
                              AND PACIFIC AFFAIRS

                        LISA MURKOWSKI, Alaska, Chairman

    LAMAR ALEXANDER, Tennessee           JOHN F. KERRY, Massachusetts
    CHUCK HAGEL, Nebraska                JOSEPH R. BIDEN, Jr., Delaware
    LINCOLN CHAFEE, Rhode Island         RUSSELL D. FEINGOLD, Wisconsin
    GEORGE ALLEN, Virginia               BARACK OBAMA, Illinois

                                      (ii)

    ?

                                C O N T E N T S

                                  ----------
                                                                       Page

    Hon. Sam Brownback, U.S. Senator from Kansas, opening statement..     1
    Dr. Robert Desowitz, Adjunct Professor of Epidemiology, School of
      Public Health, University of North Carolina, Chapel Hill, NC...    32
        Prepared statement...........................................    34
    Dr. Anne Peterson, Assistant Administrator for Global Health,
      U.S. Agency for International Development, Washington, DC......     4
        Prepared statement...........................................     8
    Dr. Donald Roberts, Professor, Department of Preventive Medicine
      and Biometrics, Uniformed Services, University of Health
      Sciences, Bethesda, MD.........................................    23
        Prepared statement...........................................    25

                                     (iii)

      NEGLECTED DISEASES IN EAST ASIA: ARE PUBLIC HEALTH PROGRAMS WORKING?

                                  ----------

                           WEDNESDAY, OCTOBER 6, 2004

                                   U.S. Senate,
        Subcommittee on East Asian and Pacific Affairs,
                                Committee on Foreign Relations,
                                                        Washington, DC.
        The subcommittee met at 2:36 p.m., in room SD-419, Dirksen
    Senate Office Building, Hon. Sam Brownback, chairman of the
    subcommittee, presiding.
        Present: Senator Brownback.

      OPENING STATEMENT OF HON. SAM BROWNBACK, U.S. SENATOR FROM
                                 KANSAS

        Senator Brownback. We'll call the hearing to order.
        Thank you all for joining us today. Appreciate your being
    here.
        The purpose of the hearing is to discuss ongoing efforts to
    control malaria and what the U.S. Government is doing, what the
    international community is doing, and what is taking place.
        I am delighted to have Dr. Peterson here with us, and we
    will also have some testimony from other witnesses as well.
    Also, I want to note your personal service in the region, in
    Africa, as a physician and the work that you have done
    previously, and that is quite noteworthy and highly
    appreciated.
        I was saying to Dr. Peterson before we started the hearing,
    this has really attracted my attention from the standpoint of
    the number of deaths and morbidity that has been going on due
    to malaria. This is something that we can deal with and I do
    not think we have dealt with effectively.
        I want to go through a few charts that we have.
        The burden of malaria: This disease is a huge killer and
    much more common than anything else that is out there. As I
    understand, it is the leading killer of children in Africa and
    third leading in the world.
        If we compare what has taken place globally, we have got
    some charts to show some of what happened during the global
    eradication campaign years. When we used a very aggressive
    application of pesticide--in this case DDT--we had some very
    promising historical trends regarding what was taking place in
    treatment and dealing with the disease of malaria. This is a
    chart that shows global rates, and I do not think, Dr.
    Peterson, you can probably see the years very well, but this is
    1900 here and it goes to 1990. We can see that when we really
    got aggressive on dealing with this and using all the tools
    available, particularly in this case, pesticides, DDT, global
    rates went down aggressively. But they are spiking back up. The
    red line here, which is Africa, is spiking up aggressively,
    which to me is an area of great concern--that we see that rate
    jumping back up, where it has not shown a similar spike in
    other countries in Asia, Central and South American countries.
        Here we see rates in some Asian countries. I have a chart
    up next that focuses on the same sort of thing. It shows much
    the same issue. These are Asian countries: Bhutan, Burma, Sri
    Lanka, India. We have got a rate here in 1965 to 1969 where
    there was aggressive spraying taking place, a multifaceted
    approach, very low infection rates, and then when that lost
    favor, the rates go up very high in these selective countries.
        In South American countries, we show some of the same
    things. I have a comparison chart of 1960 to 1995. Here are the
    1960's charts of malaria rates in South America. You can see
    the continent was really doing very well on infections on a per
    capita basis. By 1995, spraying is out of vogue, out of favor,
    and the rates go up dramatically in South America. This then
    puts, obviously, people there at much greater potential for
    their own harm, but also infection possibilities back into the
    United States.
        The next chart. Resurgence is directly linked to DDT
    spraying or the lack thereof. As the number of sprayed
    households in South America increases, the excess cases over
    the amount seen during spraying exponentially increases. And
    this is just one of those inverse relationships where the
    numbers of cases were going down, but then when you stopped
    spraying, and the cases took off.
        Even when DDT was being phased out internationally for
    agricultural use, Secretary Powell emphasized the dire
    humanitarian need for DDT to control malaria. We all know the
    difficulties of DDT and that the removing of it in this country
    is one of the things that brought the bald eagle back after
    numbers of eagles were down due to widespread agricultural
    spraying. But what we are talking about here is much more
    targeted spraying, household spraying, not the broad
    agricultural spraying that was used with DDT, that brought the
    weakening of the eggshell around the eagles' eggs that caused
    so much trouble here in this country.
        But what we are talking about is a targeted spraying, to
    what the Secretary is referring, in recognition of the dire
    humanitarian need for DDT to fight malaria in Africa, an
    exception will be made for those purposes and should be. I
    think this is one of those cases where you have got a clear
    need and we have a targeted basis to be able to use it, and we
    can save a lot of lives.
        But the WHO and other donors ignored this call. Some Asian
    countries and South Africa were able to keep spraying with DDT
    without those donor funds. They did it without donor funds, and
    we can see from South Africa's experience that Secretary Powell
    was absolutely right. Here we can see the South African model,
    what went wrong when they stopped DDT and the wrong medicine.
    Cases skyrocket. They said, we have got to stop. They went the
    other way. Cases of malaria go down.
        South Africa had been controlling its malaria for years
    with DDT. Environmental activists pressured the government the
    following year to stop these measures, prioritizing
    hypothetically unproven environmental concerns over the many
    lives of tiny children and moms. And we can see then what
    happens in that situation.
        Again, I want to emphasize we are not talking about the
    agricultural use, widespread use of DDT. This is household
    spraying, very narrow, very targeted.
        So the government reinstated DDT spraying, the effective
    drug therapy of the ACT drug, and its cases fell again. It is a
    tried and true approach to conquering malaria.
        The donor community, which launched the Roll Back Malaria
    program, did not support these measures, the DDT and ACT drug
    measures. And since the Roll Back Malaria promise to reduce the
    malaria burden by half, the trend has actually gone in the
    other direction, and we have seen that take place now.
        We have another chart. And we will provide all these to you
    as handouts, but I wanted to get them out and for those that
    were in attendance.
        We can actually see the Roll Back Malaria campaign coming
    in and actually numbers have gone up. The Roll Back Malaria has
    failed. Millions of deaths have resulted each year since the
    Roll Back Malaria made its promise. Not only has the donor
    community failed to incorporate the proven DDT intervention,
    but they have refused to support effective treatments. In fact,
    today UNICEF is handing out pills that do not work to Sudanese
    refugees in Darfur. We all know the situation in Darfur. But to
    give them the medicines that do not work, I think, to me, is a
    double tragedy.
        The USAID record is one, I am afraid, that is not that
    good. Many words have been said that we need to do things, but
    effective interventions have been few and the dollars have
    been, I do not believe, effectively targeted. You can see that
    AID has put forward statements that it wants to step its
    efforts up, but they have not included funding real
    interventions in suffering countries. It refuses to fund drug
    purchases that actually will work, is requiring Africans to buy
    the bednets, and is not supporting the use of DDT.
        I do want to note a good story on this, though. The Global
    Fund is an exception to some of the trends we have seen of the
    public sector entities, like USAID and the Roll Back campaign.
    The Global Fund, after public pressure earlier this year,
    reversed its drug policy and it does support some DDT targeted
    spraying and is moving in the right direction.
        I put this all forward because I look at this and I just
    think we are putting some money forward, we are putting some
    effort forward, but if we do not get the policy right on it, we
    are going to keep getting people dying of this and having
    morbidity as a result of malaria, which is something that we
    can handle in today's day and age. We are seeing the impact in
    Africa. It does not need to take place.
        I do realize it will take some difficult political
    decisions because there is going to be a fair pushback from
    some activists that do not want anything to do with DDT and do
    not want these drugs used. Yet, if that is the effective way
    and we can get these trend lines going back in the right
    direction, I would urge us to do that with U.S. Government
    funds. I think you will find a lot of support here if the
    Government gets on programs that do work and we do get these
    deaths and morbidity by malaria moving in the right direction.
        We will have two panels today. We do have a series of votes
    this afternoon. I am hopeful we are going to be able to get all
    of this together and into the record. Dr. Anne Peterson is the
    Assistant Administrator for Global Health, U.S. Agency for
    International Development. That will be the first panel
    presentation. Then we have two expert witnesses that will be
    presenting afterwards.
        I did have a staff member just come back from a conference
    in Africa, meeting with a number of recipient countries who
    were begging her that they be allowed--and they are getting
    funding from us and from other international groups--for that
    funding to go toward intervention strategies, use of pesticides
    and the application of pesticides, use of effective drug
    regimes, and not be used for technicians, conferences, experts.
    They want help actually putting the medicine in the hands of
    people, buying the medicines, and using the pesticides
    directly. They want intervention strategies, not technicians.
    They were really pleading with her and through her, with me,
    that they be helped on these effective strategies.
        So, Dr. Peterson, I know you bring a lot of personal
    experience and knowledge to these issues and to Africa, and I
    hope that this is one where we can work closely to get on a
    policy track that starts reducing these cases of malaria
    instead of the continued growth.
        Thank you for joining us today. I will take your full
    testimony into the record. You can summarize. You can present
    it, whatever you would like to do. But delighted to have you
    here.

      STATEMENT OF DR. ANNE PETERSON, ASSISTANT ADMINISTRATOR FOR
       GLOBAL HEALTH, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT,
                             WASHINGTON, DC

        Dr. Peterson. Thank you, Senator. I really appreciate your
    convening this important hearing. I get to talk very often
    about HIV/AIDS and not so often about malaria, and as I think
    you pointed out very nicely, this is an area that is out of
    control. It is growing and it needs the attention of Congress.
    So I am very pleased that you have convened this hearing and
    invited me.
        You talked about the impact of malaria on the families, on
    women and children. I would add that we have a newly identified
    population that is at risk. Those who are HIV-positive are at
    much higher risk of dying of malaria because of their
    compromised immune system. As we are looking at the growth of
    malaria, we have a new and large vulnerable population that is
    getting larger by the minute. So coinfection is a big issue.
        I appreciate your understanding of the issues and you have
    raised a number of very deep concerns that I hope I will begin
    to address, as I give my opening statement and in answering
    some of the specific questions for you.
        We do know that most of the people who are affected are
    women and children. And the U.S. Government has been a leading
    force in the worldwide battle against malaria. Just this year
    we had $80 million for malaria. This is a four-fold increase
    over the past 4 years. This is the kind of scale-up that is
    necessary to begin to curb the kinds of trends that you have
    just shown to reach national level impact instead of small-
    scale projects. We are moving toward better policies and
    visibly stronger programs. You talked about getting drugs into
    the hands of people, but also meeting that need based on strong
    policies. That is part of the leadership that the U.S.
    Government has been doing in the past years.
        Seven countries, specifically in Asia, receive support for
    malaria with a major focus on limiting the emergence and spread
    of drug-resistant forms of malaria in the Mekong subregion of
    Southeast Asia, including Afghanistan, Cambodia, India,
    Indonesia, Philippines, Nepal, and Thailand.
        We provide support to national malaria programs in 20
    countries in sub-Saharan Africa where the burden of deaths is
    the highest.
        The international experts have identified a policy of three
    priority interventions that together reduce the deaths of
    illness from malaria. There is not a single bullet. Because of
    the complex nature of malaria, its transmission, and the people
    at risk, you need a comprehensive package.
        The first component of the package is prompt and effective
    treatment with an antimalarial drug within 24 hours of the
    onset of fever.
        The second component is prevention of malaria through the
    use of insecticide-treated bednets for young women and
    children.
        And the third component is provision of intermittent
    preventive treatment for pregnant women as part of their
    antenatal services.
        Other parts of an integrated program, depending on the
    epidemiology and the mosquito characteristics, are indoor
    residual spraying and the use of insecticides and environmental
    cleanup.
        We know that a comprehensive approach that includes
    prevention, an effective and prompt treatment, and research for
    better tools is the most effective strategy for saving lives.
    We have seen this in Asia with the recent emergence and spread
    of multidrug-resistant malaria. There has been a threat to
    reverse the gains that we have seen in malaria. We have been
    very concerned about this increase and invested significant
    resources into documenting the speed and the scope of the
    developing antimalarial drug resistance and the burgeoning
    deaths due to malaria.
        Because of the cross-border nature of the drug-resistant
    malaria problem, surveillance and disease control capacity are
    needed in Southeast Asia. We have been supporting a coordinated
    approach since 1999, together with the World Health
    Organization, to monitor drug resistance. The U.S. Centers for
    Disease Control and Prevention have been a very close colleague
    in our efforts to do the surveillance. As a result of the drug
    resistance data, USAID, the other donors, and the national
    governments themselves can bring forward the appropriate
    policies and, in fact, have updated a number of the East Asian
    countries' malaria treatment policies. So again, the right
    policy is what is needed. You need to have the right data to
    make that happen.
        The malaria programs in many of the Mekong Delta region now
    use combination therapy which includes the new artemisinin-
    based drugs. USAID has played a major role to change national
    malaria policy to ACT in three of the six countries in the
    Mekong region. We know from many infectious diseases that
    simultaneous use of multiple drugs instead of a single drug
    regimen slows the development of resistance. In fact, a fair
    amount of the change in trends of malaria that you showed is
    due to increasing resistance and the fact that we had single
    drug regimen in the past.
        The World Health Organization and Roll Back Malaria,
    including USAID, now recommend that all countries experiencing
    resistance should move from a first-line single therapy to
    combination therapy, ideally including artemisinin drugs. In
    fact, USAID is working in a number of countries to grow more of
    the plant from which artemisinin is derived in order to
    increase the supply of the artemisinin drugs.
        We predict that there will be a need for almost 300 million
    treatments annually by 2008, and the majority of those drugs
    are likely to be needed in Africa. Therefore, it is very
    important to expand the production of the artemisinin.
        We have also been working with global partners to increase
    the pharmaceutical producers to gauge their interest and
    willingness to scale up production. We have been working with
    financial institutions like the World Bank and the Global Fund
    to see if they are willing to mobilize sufficient support for
    financing of ACTs, and we have worked with the technical
    agencies to prepare countries for effective application of
    those resources.
        We have been working with 11 of the East Asian countries
    that have received the Global Fund awards for malaria to make
    sure that the policies and the technical assistance that they
    need are in place to retrain the physicians, the health care
    providers, and the providers of the drug itself to be ready to
    move to the new drug regimens.
        Just last week in Nairobi at a Global Fund programming
    meeting, USAID and HHS provided technical support to 25
    recipient countries, including Pakistan and Indonesia, to pave
    the way for ACT introduction, including addressing drug
    management, policy reform, and appropriate use.
        But we need to remember that even if we get ACTs out to all
    of the countries and if everyone uses them properly, malaria
    parasites can still grow in patients if we have poor drug
    quality or wrong formulations. Unlike in developed countries,
    poor quality medicines, either produced intentionally as
    counterfeits or accidentally because of poor quality control,
    are readily available on the open market and often are visually
    indistinguishable from the genuine product. USAID has been very
    involved in looking at the drug quality issue especially for
    malaria drug products. In one study in East Asia, 38 percent of
    artesunate samples from drug shops in Burma, Cambodia, Laos,
    Thailand, and Vietnam contained insufficient or no active
    ingredient. Other studies have detected other poor quality
    antimalarials, including chloroquine, mefloquine, and quinine.
        Besides contributing to the drug resistance, which will
    exacerbate the trends in malaria, poor drug quality is equally
    dangerous for the individual patient. In 1999, at least 30
    people in Cambodia died after taking SP, an older and less
    effective antimalarial drug, which was sold to them as
    artesunate. Poor quality drugs sometimes also contain toxic
    products that can be lethal.
        USAID is strengthening national drug regulatory
    authorities. The aim is to improve the manufacturing of
    pharmaceuticals through good manufacturing practices, including
    drug quality control in national programs. Across the Mekong
    Delta region, USAID provides support for 37 sentinel
    surveillance sites for monitoring drug resistance. These sites,
    the national malaria control programs, and drug regulatory
    authorities will be linked to create a regional warning system
    for poor quality drugs found in the market. USAID is also
    working to build similar sentinel surveillance systems in
    Afghanistan, Bangladesh, Nepal, and India.
        Prevention, though, is still the key and use of insecticide
    at the household level is the mainstay of prevention. There are
    two main ways to administer insecticide treatment at the
    household level: Through indoor residual spraying, as you
    talked about, which was the centerpiece of the eradication
    campaign of the fifties and sixties, or through the more recent
    advent of insecticide-treated nets, ITNs. For those individuals
    at risk for malaria, ITNs are still the most practical and
    effective means for protecting the largest percentage of
    populations, and consistent use of ITNs has been shown to
    decrease severe malaria by 45 percent, reduce premature births
    by 42 percent, and cut all-cause mortality by 17 to 63 percent.
    In Cambodia, where malaria was a major problem among rural
    populations, with strong USAID support, a twin strategy of
    deploying ITNs and effective treatment reduced malaria
    incidence by more than 70 percent.
        USAID does provide free nets and promotes targeting for
    heavily subsidized ITNs to the most vulnerable populations,
    pregnant women and children under 5, and the poorest
    populations. Nets can be deployed now in desperately poor
    countries where malaria-related deaths are highest and can be
    put into the hands of parents who want to protect their
    children instead on relying on government systems that, as you
    pointed out, in the past have not taken care of their
    populations.
        The other way to bring insecticide into play in preventing
    malaria is through IRS, indoor residual spraying. Contrary to
    popular belief, USAID does support the use of DDT in its
    malaria control programs. We are fully supportive of careful
    use of DDT through indoor spraying of the interior walls. It
    has a potential role in malaria prevention in some countries in
    certain circumstances, but a global one-size-fits-all strategy
    that requires the use of DDT might be counterproductive.
        Last December, I visited Ethiopia as they were responding
    to an unprecedented wave of malaria deaths. USAID was
    supporting Save the Children in the provision of both nets and
    indoor residual spraying. In the Cambodia example I just
    mentioned, they chose and were successful at turning around a
    malaria upsurge using bednets plus ACTs.
        As we consider the plight of those who face these deadly
    diseases, we must act rapidly with the most effective methods
    of treatment and prevention. We must and are responding to this
    challenge, but I must emphasize that there is no silver bullet,
    no single intervention that is the answer to malaria. We must
    support a comprehensive approach that includes prevention,
    effective treatment, and research for better tools.
        The session was to talk a little bit about TB, and I will
    just say that TB, like malaria, is on the upsurge. It has some
    of the same problems of old drugs and too little attention for
    the scope of the epidemic.
        Similarly, when we look at the child survival strategies
    overall, malaria is one of the major killers and we have great
    opportunities to do more in these areas of international health
    than we have been doing. USAID is spending a lot of time trying
    to prioritize where the scarce resources that we have can make
    the most difference for women and children. If we only have the
    resources before us, what are the biggest priorities? Where can
    we make the most difference with the interventions that we
    have, which are the most cost effective, and which will save
    the most lives? Public health is always about balancing
    competing goods, and in malaria, both in treatment and
    prevention, we have competing interventions, we have competing
    goods, and it is a balance for each country, for each place,
    and for each circumstance. It really needs a comprehensive
    strategy.
        Thank you.
        [The prepared statement of Dr. Peterson follows:]

     Prepared Statement of Dr. Anne Peterson, Assistant Administrator for
     Global Health, U.S. Agency for International Development, Washington,
                                       DC

        Thank you, for convening this important hearing and for inviting me
    to testify on a very deadly disease, malaria.
        Malaria affects the health and wealth of nations and individuals
    alike around the world. It is not only a disease of poverty but also a
    disease that causes poverty and is a major constraint to economic
    development.
        As a public health physician who has worked internationally and
    domestically for more than 20 years, I am very pleased at the growing
    interest and response to the challenge malaria poses. The international
    community has mobilized funding and action recently to develop and
    implement sustainable actions against malaria. I will address the
    burden and suffering caused by malaria with a special focus on East
    Asia and outline what USAID is doing to save lives now and in the
    future.
    Malaria
        Worldwide, it is estimated that malaria kills more than one million
    people each year, making it the world's third deadliest infectious
    disease, after AIDS and tuberculosis. But malaria--spread by
    mosquitoes--is the most common of the three diseases, with more than
    500 million persons experiencing acute malaria illness annually,
    compared with 5.3 million for AIDS and 8.8 million for TB. Each year
    there are about 3.6 million confirmed malaria cases and 6,000 malaria
    deaths in Asia and the Near East. However, there are probably many more
    unreported cases and deaths given that malaria occurs mostly in rural
    areas where health services and surveillance are weak. Malaria also
    accounts for a loss of approximately $12 billion a year in gross
    domestic product in Africa alone.
        Eighty-five percent of malaria deaths occur in Africa, while about
    eleven percent of the deaths occur in Asia and the Near East. In
    Africa, malaria's greatest impact is felt by very young children and
    pregnant women because of their reduced immunity to the malaria
    parasite. As many as a quarter of childhood deaths in endemic areas of
    Africa are attributable to malaria. But infection of African women
    during pregnancy also takes a huge toll, both on the health of the
    mother as well as on the development of her unborn child. Placental
    infection in Africa is a significant contributor to low birthweight and
    subsequent neonatal death. In areas of unstable or epidemic malaria
    such as Asia, all persons are also at risk of serious illness and
    death. The drain on the physical and financial resources of households
    and communities of the disease, as well as the often ineffective
    attempts to respond to it, is well documented.
    Scope of USAID Role in Battling Malaria
        The United States is and has been a leading force worldwide in the
    battle against malaria. USAID has directed and supported critical
    research that forms the backbone of some of the most effective
    interventions, including insecticide-treated mosquito nets (ITNs),
    rapid diagnostics, and drugs. It is also studying ways to identify and
    deal with increasing drug resistance. Our technical and financial
    resources are being brought to bear around the world and leveraged to
    increase global commitments to reduce illness and death. This year
    USAID committed over $80 million for malaria programs--a nearly four-
    fold increase since 1998 when USAID's Infectious Disease Initiative was
    launched. These new and expanded resources have allowed for a
    significant scaling-up of malaria activities to have national level
    impact and have led to increased coverage with interventions, better
    policies and visibly stronger programs. Many countries in Asia are also
    receiving support for malaria from the Global Fund to Fight AIDS, TB,
    and Malaria. I will say more about the Global Fund later.
        Seven countries in Asia receive USAID support for malaria, with a
    major focus on limiting the emergence and spread of drug-resistant
    forms of malaria in the Mekong subregion of Southeast Asia. These
    include Afghanistan, Cambodia, India, Indonesia, Philippines, Nepal and
    Thailand. Activities supported are determined by local priorities,
    resource availability, and complementary activities by other donors and
    multinational institutions.
        The international efforts to fight malaria are largely coordinated
    by a global partnership that includes leaders from across Asia, local
    health institutions, the World Health Organization (WHO), UNICEF, World
    Bank, UNDP, multilateral agencies, the Department of Health and Human
    Services (HHS), specifically the Centers for Disease Control and
    Prevention (CDC), international, national and local NGOs, and the
    private sector. USAID is a key partner in the Roll Back Malaria
    Partnership.
    Integrated Flexible Program Approach Saves Most Lives
        International experts have identified three priority interventions
    to reduce deaths and illness from malaria, each of which is backed by
    solid evidence of their effectiveness. These three interventions are
    consistent with USAID's priority areas for investment in malaria. They
    are:

              1. Provision of prompt and effective treatment with an
            antimalarial drug within 24 hours of onset of fever;
              2. Prevention of malaria primarily through the use of
            insecticide-treated mosquito nets (ITNs) by young children,
            pregnant women, and other high-risk populations; and
              3. Provision of intermittent preventive treatment (IPT) for
            pregnant women as a part of the standard antenatal services--
            proper use of which can reduce overall child deaths by up to 30
            percent and significantly reduce sickness in children and
            pregnant women [this one is not really a focus in Asia since
            little has been documented on malaria in pregnancy].

        Other parts of an integrated program--based on appropriate
    epidemiology and mosquito characteristics--are:

              a. Indoor Residual Spraying and use of insecticides, and
              b. Environmental Clean-up to remove mosquito breeding sites.

        The three interventions to reduce deaths and illness from malaria
    are internationally agreed upon and can be adapted to the local context
    depending on the needs and priorities.
    Improving Treatment With Effective Drugs
        Historically, national malaria control programs have relied
    primarily on monotherapy with drugs, such as chloroquine, amodiaquine,
    or sulfadoxine-pyrimethamine SP (Fansidar). These are the
    first-line treatment for Plasmodium falciparum infections, which are
    responsible for the vast majority of deaths due to malaria. However,
    many of these drugs are no longer useful in Southeast Asia as well in
    other parts of the world including Africa because of widespread drug
    resistance among P. falciparum parasites. Malaria programs in many of
    the Mekong countries now use a combination therapy which includes one
    of the newer artemisinin-based drugs. In Cambodia, Indonesia, and
    Thailand, USAID has been supporting efforts to improve rapid diagnosis
    and treatment of malaria, particularly in poor, underserved populations
    or where the disease is reemerging. Although prohibited from providing
    assistance to Burma, USAID is providing support to nongovernmental
    organizations (NGOs) in western Thailand to address malaria and other
    priority infectious diseases among Burmese migrants.

    USAID Instrumental in Tracking Spread of Resistance--Documenting Need
            for Better Drugs
        Like many infectious diseases such as TB, gonorrhea, and pneumonia,
    resistance to antimalarial drugs can develop and spread in areas where
    these medicines are not used properly or where their quality is poor.
    In Southeast Asia, strains of P. falciparum have developed resistance
    over the past 20 years to multiple antimalarial agents and very few
    drugs remain effective.
        Because of the cross-border nature of the drug-resistant malaria
    problem and the need for improved surveillance and disease-control
    capacity in Southeast Asia, USAID has been supporting since 1999 a
    coordinated, regional approach led by the World Health Organization to
    monitor drug-resistant malaria in East Asia and, more recently, in
    South Asia and limit its spread. The U.S. Centers for Disease Control
    and Prevention have also been involved in these efforts. As a result of
    drug-resistance data collected with the assistance of USAID and other
    donors and partners, malaria treatment policies have recently been
    updated in a number of East Asian countries including Cambodia and
    Thailand.
        At the country level, USAID is working with national malaria
    programs to: Improve the diagnosis of P. falciparum; providing
    effective combination therapies to vulnerable populations; expanding
    the use of insecticide-impregnated mosquito nets to limit transmission
    of malaria and the need for antimalarial drugs; and monitoring drug
    resistance, drug-use practices, and drug quality.

    Drug Resistant Strains Present Additional Challenges
        East Asia and the Pacific include Burma, Cambodia, China, East
    Timor, Indonesia, Laos, Mongolia, Philippines, Thailand and Vietnam.
    Populations at risk for severe disease and death in East Asia include
    children, pregnant women, people routinely in contact with forested
    areas where malaria-transmitting mosquitoes live, and rural and mobile
    populations with limited access to health services. While improved
    access to prompt diagnosis and effective treatment has contributed to a
    decrease in the number of malaria deaths here over the past decades,
    the recent emergence and spread of multi-drug-resistant (MDR) malaria
    threatens to reverse these gains as treatments become more complicated
    and costly.
        USAID has been instrumental in documenting the extent of the drug-
    resistance problem as well as studying the factors--such as poor drug
    use and poor drug quality--that are contributing to the emergence and
    spread or resistance. This information is critical for focusing
    interventions on priority areas in order to preserve the effectiveness
    of current antimalarial drugs that are safe and affordable. Only a
    limited number of alternative drugs are available if the current
    therapies fail and there is little economic incentive for new drug
    discovery and development, given its high cost and the fact that
    malaria predominantly affects the world's poorest nations. Newer drugs
    are also likely to be significantly more expensive which can limit
    people's access to them, especially in poor, rural communities. If
    steps are not taken immediately to address the root causes of drug
    resistance, these drug combinations will also lose their effectiveness
    in the near future.

    Identifying Factors Contributing to Drug Resistance
        There are two main factors that are driving the emergence of drug-
    resistant malaria in East Asia and elsewhere. They are: poor use of
    antimalarial drugs; and use of poor-quality antimalarial drugs. Both
    result in under-dosing which can allow malaria parasites to survive and
    adapt while exposed to sub-lethal amounts of the medicines. On the
    issue of poor drug use, health care providers and drug sellers can
    contribute to the problem in several ways, including: prescribing/
    dispensing the wrong drug when a patient has malaria; and prescribing/
    dispensing the proper drug, but in an incorrect dosage. Patients can
    assist the development of drug resistance by failing to complete the
    full drug course when they are ill. This may occur because they only
    had enough money to buy a partial treatment or because they stopped
    treatment once they started feeling better. Self diagnosis and
    medication can also lead to the wrong drug being used and/or the wrong
    dose. This occurs frequently as people go to traditional healers and
    drug sellers first before visiting trained health providers, especially
    if the official sources are not always stocked with the first-line
    therapy. Since prescriptions are rarely required for obtaining
    antimalarial drugs in the private and informal sector, patients have
    easy access to medicines. This may be especially common in
    international border areas where patients are poor and they may be
    avoiding the public health care system because they are in the country
    illegally or they do not speak the local language.
        USAID has been instrumental in documenting the extent of the drug-
    resistance problem in the Mekong region, as well as studying the
    factors--such as poor drug use and poor drug quality--that are
    contributing to the emergence and spread or resistance. This three
    pronged approach in the Mekong is unique in allowing decision-makers to
    more broadly understand factors that affect community behaviors and to
    monitor their impact on drug resistance. Documentation of changes in
    drug resistance, quality and use will enhance the ability of countries
    to evaluate their national malaria drug policy and to introduce changes
    from a more informed perspective. This information is critical for
    focusing interventions on priority areas in order to preserve the
    effectiveness of current antimalarial drugs that are safe and
    affordable. A recent study of antimalarial drug use in western Cambodia
    revealed that only 11 percent of people who had malaria were using the
    recommended first-line therapy of artesunate+mefloquine, despite
    efforts by health officials to make the drug combination widely
    available through both the public and private sector. Moreover, 41
    percent of people receiving treatment for malaria did not take the full
    course of the medicine. And 50 percent of people were self-prescribing
    with medications obtained in the private market.
        Even if everyone in East Asia uses antimalarial drugs properly,
    malaria parasites can still be exposed to sub-lethal doses of
    antimalarial medicines if poor quality drug formulations are used to
    treat the disease. Unlike in developed countries, poor-quality
    medicines--either produced intentionally as counterfeits or
    accidentally because of poor quality control--are readily available on
    the open market and often visually indistinguishable from the genuine
    products. In one study in East Asia, 38 percent of ``artesunate''
    samples from drug shops in Burma, Cambodia, Laos, Thailand, and Vietnam
    contained insufficient or no active ingredient. Other studies have
    detected other poor-quality antimalarial drugs, including chloroquine,
    mefloquine and quinine. Besides contributing to drug resistance, poor
    drug quality has real health implications for the individual patient.
    In 1999, at least 30 people in Cambodia died after taking SP (an older,
    less effective antimalarial drug) which was sold to them as artesunate.
    Poor-quality drugs can also contain toxic products which can be lethal
    if ingested.

    Ensuring Drug Quality and Appropriate Drug Use
        USAID is strengthening national drug regulatory authorities. The
    aim is to improve the manufacturing of pharmaceuticals through good
    manufacturing practices, including drug quality control in national
    malaria programs. At 17 sentinel surveillance sites in six countries in
    Southeast Asia and Africa, the United States Pharmacopeia Program (USP
    DQI) has trained staff of national malaria programs to collect and test
    drugs for quality, using low technology screening methods. Sentinel
    surveillance sites, national malarial control programs and drug
    regulatory authorities will be linked to create regional warning
    systems for poor quality drugs found in the market. USP DQI has also
    provided technical assistance in good manufacturing practices to
    selected producers of malaria drugs in Cambodia, Laos, and Vietnam. At
    the same time, USAID is also working with the Management Sciences for
    Health (MSH) Rational Pharmaceutical Management (RPM) Plus program to
    identify household and provider drug management and use problems, and
    to strengthen the capacity of local health officials and partners in
    East Asia to utilize this information to improve access to high-quality
    antimalarial drugs in the public and private sectors and to ensure
    their appropriate use. RPM Plus is also working with WHO and other
    partners to develop and implement a standardized methodology for
    monitoring the extent of ACT introduction as first line therapy in
    several Mekong countries.

    Mainstreaming Rapid Diagnostics
        New community-based approaches to diagnostics, including rapid
    diagnostics tests, can help overcome insufficient laboratory capacity
    or resources so that disease surveillance information can be rapidly
    used for action. USAID is working to develop diagnostics tests for both
    P. falciparum and P. vivax infections and assisting in mainstreaming
    their use around the world. In Southeast Asia, artemisinin-based
    combination therapies (ACTs) are routinely deployed with rapid
    diagnostic test kits so that these newer and more-costly therapies are
    used only when needed. USAID has also been supporting the development
    of quality assurance system to allow countries in East Asia to verify
    that their rapid tests are not degrading over time under normal field
    conditions.

    Combination Therapy Recommended by WHO, Roll Back Malaria and USAID
        We know from many infectious diseases that simultaneous use of
    multiple drugs instead of a single regimen slows development of
    resistance. The World Health Organization (WHO) and the Roll Back
    Malaria partnership (including USAID as one of the partners) now
    recommend that all countries experiencing resistance to their current
    first-line, single-drug therapy should change to a combination therapy,
    ideally including an artemisinin drug. The rationale for using
    combination therapy for malaria is similar to that for the treatment of
    tuberculosis, cancer, and HIV infections. When used alone, antimalarial
    drugs are more likely to select resistant parasites. The addition of a
    rapidly-acting and highly effective second drug, such as artemisinin or
    one of its derivatives, greatly reduces the probability of selecting
    parasites that are resistant to both drugs. This should prolong their
    useful therapeutic lifetimes. The WHO and Roll Back Malaria (RBM)
    recommend several ACT options: artemether/lumefantrine
    (Coartem) or artesunate plus either amodiaquine, sulfadoxine-
    pyrimethamine, or mefloquine. USAID has supported the development and
    critical research for ACTs.
        Over the past year the RBM partnership has developed a
    comprehensive ``roadmap'' on how best to ensure access to and effective
    use of ACTs. The roadmap highlights major milestones and potential
    barriers towards achieving full access to and appropriate use of ACTs--
    and more importantly, establishes a framework for prioritizing the
    actions of the RBM partnership.
        USAID and our global partners have worked with endemic countries
    over the past several months to assess their treatment needs. We are
    working with pharmaceutical producers to gauge their interest,
    willingness, and ability to scale-up production of ACT as well as with
    financial institutions to determine their ability to mobilize
    sufficient support for the financing of ACTs. We are also seeking help
    from development and technical support agencies to ensure in-country
    support for effective application of these resources.
        We have identified four potential ``bottlenecks'' or barriers that
    hinder access to and effective use of ACTs:

       The capacity of agricultural producers to increase their
            yields of the plant Artemisia annua, the source of artemisinin;
       The number and capacity of pharmaceutical industry to
            produce high quality ACTs;
       The availability of resources to finance their procurement;
            and
       The availability of training and capacity to build support
            in country for widespread and appropriate use.

        The identification of these potential bottlenecks in turn has led
    to an agreement within the RBM partnership of the key actions needed
    for their resolution.

    Enhancing Production Quality and Capacity
        Ensuring high quality and low cost ACTs requires an adequate pool
    of qualified ACT producers. Currently, there is only one pharmaceutical
    company which has been ``prequalified'' by WHO as a manufacturer of
    quality ACTs. USAID in 2004 and 2005 will continue to work with WHO to
    maximize the number of ``prequalified'' companies. USAID's support will
    target both upgrading the production capacity of pharmaceutical
    companies to meet WHO's standards for prequalification and will assist
    the WHO in expediting the evaluation process. USAID and its partners in
    Roll Back Malaria are currently working with legitimate local producers
    in Asia to assist them in incorporating Good Manufacturing Practices
    into their drug production facilities. This will help reduce the number
    of poor-quality antimalarial drugs available on the market, improve
    cure rates, and slow the emergence of drug resistance.

    Financing ACTs
        USAID and RBM partnership is taking a two-pronged strategy: (1) To
    identify financing over the next 18-24 months for country procurement
    of ACTs; and (2) to address the longer-term financing of ACTs. To meet
    the long-term demand, USAID has commissioned the Institute of Medicine
    to convene an expert panel to study options for funding ACTs from 2007
    and beyond. This study has just been released and provides a clear and
    practical ``roadmap'' for the long-term financing of ACTs.
        While recent public discussions of malaria treatment have largely
    focused on which drugs to use, the real challenge to providing
    effective treatment is in the ``nuts and bolts'' of delivering these
    drugs to those in need: Enabling policies must be in place; logistic
    and management capabilities need to be upgraded; health workers need to
    be appropriately trained and supported; and communities and households
    need to be knowledgeable and cognizant of appropriate services. USAID
    is working with partners in the public and private sector in all of
    these areas to ensure that effective, affordable, and safe antimalarial
    drugs get to the patients who need them.
        With these and other similar challenges in mind, USAID is bringing
    the full weight of its technical and programmatic resources in support
    of those countries that have made changes in their policies to ACTs to
    ensure that they have adequate support in procurement and management of
    ACTs, training of health workers in diagnosis and use of ACTs for
    treatment of malaria, and mobilizing communities and households. USAID
    is also presently working with 25 Global Fund recipient countries--11
    in East Asia have received GFATM awards for malaria--in preparing
    detailed plans for the introduction of ACT over the next year.

    Prevention of Malaria
        For those individuals at risk from malaria, insecticide treated
    nets (ITNs) are the most practical and effective means for protecting
    the largest percentage of populations. Consistent use of an ITN has
    been shown to decrease severe malaria by 45 percent, reduce premature
    births by 42 percent and cut all-cause child mortality by 17-63
    percent. In most settings, ITNs are unquestionably the most effective
    way that families can protect themselves from malaria.

    Free Nets to Those Most in Need
        USAID promotes targeting free or heavily subsidized ITNs to the
    most vulnerable (pregnant women and children under five years) and
    poorest populations--thus ensuring economics is not a barrier to net
    ownership. For example, USAID support in Indonesia helped the Ministry
    of Health to respond to malaria outbreaks and distribute 95,000 long-
    lasting insecticide treated bednets which provided protection for
    approximately 500,000 people in high-risk malaria areas of Central
    Java, and in Bali, Aceh and Lombok.
        New technologies now provide long-lasting nets and treatments that
    remove the necessity for retreatment. These technical developments, the
    product of committed commercial sector engagement with Roll Back
    Malaria partners, render ITNs even more affordable, more easily used,
    and more effective. ITNs also have an additional advantage. Studies
    show some protection of children who live nearby a net, as opposed to
    IRS where there is no added protection.

    DDT
        Contrary to popular belief, USAID does support use of DDT in its
    malaria control programs. We are supportive of careful use of DDT for
    malaria control through the spraying of interior house walls--Indoor
    Residual Spraying, or (IRS). DDT is only used for malaria control
    through this spraying method. The spraying of pesticides which may
    include DDT does have a potential role in malaria prevention in some
    countries under certain circumstances. A number of other insecticides
    can also be used for IRS, and are in many countries when those
    alternative insecticides are safer and equally effective. IRS, when
    efficiently conducted in appropriate settings, is considered to be as
    efficacious as ITNs in controlling malaria.
        From a purely technical point of view in terms of effective methods
    of addressing malaria, USAID and others have not seen IRS as the
    highest priority component of malaria programs for many reasons. In
    many cases, indoor residual spraying of DDT, or any other insecticide,
    is not practical, cost-effective and is very difficult to maintain. IRS
    requires major infrastructure, including a high level of organization,
    geographic coverage, application personnel and financial resources,
    regardless of what insecticide is used. To be effective, IRS needs 80
    percent community compliance. It is also more expensive in rural or
    peri-urban than in urban areas.
        In most countries in Africa where USAID provides support to malaria
    control programs, it has been judged more cost-effective and
    appropriate to put U.S. government funds into other malaria control
    activities than IRS. However, in countries in which circumstances
    support the use of IRS (including DDT) USAID has funded and supported
    such malaria control programs.
        USAID regulations (22 CFR 216) require an assessment of potential
    environmental impacts of supporting either the procurement or use of
    pesticides in any USAID assisted project, but if the evidence assembled
    in preparing such an environmental review indicates that DDT is the
    only effective alternative and it could be used safely (such as in
    interior wall spraying undertaken with WHO application protocols), then
    that option would be considered. The U.S government is signatory to the
    Stockholm Convention on Persistent Organic Pollutants (the POPs
    treaty), which specifically allows an exemption for countries to use
    DDT for public health use in vector control programs, as long as WHO
    guidelines are followed and until a safer and equally effective
    alternative is found.
        The United States voted in favor of this exemption. For example,
    this exemption was used to spray DDT and other insecticides in South
    Africa when certain mosquitoes developed resistance to the major
    alternative class of insecticides, the synthetic pyrethroids. Such
    situations are relatively rare, however, and demonstrate the value of
    the provisions of the POPs Treaty, which restrict and document use of
    DDT, but provide for its use when appropriate.

    Prevention of Malaria in Pregnancy
        While preventing malaria in pregnancy is not a major focus of work
    in Asia, it is in Africa. Each year, more than 30 million African women
    become pregnant in malaria-endemic areas and are at risk for Plasmodium
    falciparum malaria infection during pregnancy. Most women live in areas
    with relatively stable malaria transmission, where the major impact of
    infection during pregnancy is related to anemia in the mother and the
    presence of parasites in the placenta. The resulting impairment of
    fetal nutrition contributing to low birth weight (LBW) is a leading
    cause of poor infant survival and development in Africa. HIV infection
    diminishes even more a pregnant woman's ability to control P.
    falciparum infections. The prevalence and intensity of malaria
    infection during pregnancy is higher in women who are HIV-infected.
    Women with HIV infection are more likely to have symptomatic infections
    and to have an increased risk for malaria-associated adverse birth
    outcomes.
        WHO has recommended intermittent preventive treatment (IPT) using
    the antimalarial drug, sulfadoxine-pyrimethamine (SP), as the preferred
    approach to reduce the adverse consequences of malaria during pregnancy
    in areas with stable transmission. Since more than 70 percent of
    pregnant women in Africa attend antenatal clinics, IPT provides a
    highly effective base for programmes through use of safe and effective
    antimalarial drugs in treatment doses which can be linked to antenatal
    clinic visits. The potential of IPT to attain high levels of program
    coverage and its benefit in reducing maternal anemia and LBW makes it a
    preferred strategy in sub-Saharan Africa. In HIV-negative pregnant
    women, two doses of IPT provide adequate protection, but a minimum of
    three doses appears to be necessary in HIV positive women. Outside of
    areas with stable transmission in Africa and in other regions of the
    world, while malaria in pregnancy is a risk for both the mother and
    fetus, there is no evidence that IPT is worthwhile.
        USAID played a key role in supporting the original studies in
    Africa that documented the efficacy of IPT in preventing the impact of
    malaria on both HIV positive and HIV negative pregnant women and their
    offspring. Many countries have already changed their malaria in
    pregnancy policies. Currently, through a coalition of partners, USAID
    is assisting ministries of health in about 10 African countries to
    implement IPT and distribute ITNs as part of a package of health
    interventions at the antenatal clinic level. Over the last year this
    technical assistance has contributed significantly to revision of
    outdated policies in Senegal, Ghana, Rwanda, and Zambia and to
    increased implementation of revised policies in DRC, Tanzania, and
    Kenya. Among women attending antenatal services in Tanzania, delivery
    of intermittent preventive therapy has increased from below 30 percent
    to over 60 percent.

    Expanding Global Network
        Multilaterals, bilaterals . . . no one agency can do it all. Roll
    Back Malaria partners--leaders from across Asia, health institutions,
    WHO, UNICEF, World Bank, bi-lateral agencies, international, national
    and local NGOs, and the private sector are engaged in the fight against
    malaria. One ``home-grown'' partnership in East Asia is the Asian
    Collaborative Training Network for Malaria which focuses on training
    and information sharing. This organization was created by countries to
    deal with common issues related to malaria control. Both USAID and HHS
    have participated in the development of training strategies and
    curriculum development.

    Global Fund
        Through the Global Fund to Fight AIDS, Tuberculosis, and Malaria,
    USAID, HHS and international partners have come together to combine
    financial, technical, management, and other expertise to reduce the
    public health impact of malaria. Over the past three years, the U.S.
    government has contributed $623 million to the Global Fund, and has
    appropriated for a FY 2004 contribution of up to $547 million this
    year. USAID and HHS are presently working with 25 Global Fund recipient
    countries--11 in East Asia have received GFATM awards for malaria--some
    proposals specifically focus on drug resistant malaria and include
    efforts to address drug quality and drug management.
        We have some of the best malaria experts in the world who have been
    requested to be on technical review panels for the Global Fund for
    malaria and USAID provides in-country technical assistance to assist in
    the development of Global Fund proposals. Strategically, there is a
    rapidly evolving partnership between the Global Fund and USAID's
    malaria program. With USAID providing critical technical ``know how''
    and the Global Fund providing the resources for the procurement of key
    commodities for the prevention and control of malaria there is a
    growing optimism that malaria endemic countries can soon begin turning
    the tide against malaria.

    Partnerships
        These actors are playing unique roles--roles only they can perform
    due to their expertise, positions and responsibilities.
        Research institutions and pharmaceutical companies can develop
    improved treatments and interventions to help protect us against
    malaria and its impacts. USAID works closely with the HHS, which, with
    USAID support, provides technical assistance to the World Health
    Organization and ministries of health in a variety of areas related to
    malaria diagnosis and treatment, prevention of malaria in pregnancy,
    use of insecticide-treated mosquito nets (ITNs), indoor residual
    spraying (IRS), and monitoring and evaluation of malaria programs.
    USAID also provides funding to NIH for work on a malaria vaccine.
        Community- and faith-based organizations and other NGOs extend
    deeply into many of the most rural areas, reaching societies and
    cultures to ensure health care services and malaria treatments and
    interventions get to hard-to-reach populations.
        National governments have especially important roles to play with
    specific, attainable steps to reducing the impacts of malaria--steps
    that only they can take. The international donor community, in
    partnership with developing country partners, can ensure that technical
    and financial resources are allocated where they will be most
    effective.
        USAID is committed to working with these important partners to turn
    the tide against malaria and other infectious diseases.
        And with so many new partners, the coordination of our efforts
    becomes even more critical. This is as true among the U.S. government
    agencies as it is among our international partners, including the new
    Global Fund. Coordination efforts must occur at two levels: At
    headquarters and in the countries we are assisting.

    Research
        USAID has also targeted the creation of a vaccine for malaria. A
    vaccine candidate against malaria is currently being tested in Kenya
    and Mali where the disease disables or kills hundreds of thousands of
    people each year.
        After initial safety trials in the United States, clinical trials
    jointly supported by the Gates Foundation, the Malaria Vaccine
    Initiative began last year in Kenya with a safety study on some 50
    adults.
        The tests showed that the vaccine was safe in adults in Kenya, so
    this year testing was extended to about 50 children aged 1 to 4 years.
    The National Institute of Allergy and Infectious Diseases (NIAID), a
    component of the National Institutes of Health (NIH), is now working
    with USAID in testing the vaccine on some 40 adults in Mali to obtain
    safety data in a different epidemiological setting.
        While ACTs are now effective, we know that won't last. Research on
    new and better drugs is absolutely critical and another important part
    of USAID's strategy. We are supporting Medicines for Malaria Venture
    (MMV) and WHO in new drug development.

    Tuberculosis (TB) Background
        Tuberculosis (TB) is an ancient disease. While a cure has been
    available for over fifty years, TB still kills more than two million
    people every year. Each day, nearly 25,000 people develop active TB and
    5,000 die from their disease. Approximately one-third of the world's
    population or two billion people are infected with TB. According to the
    2004 WHO Global Report on TB, in 2002 there were an estimated 8.8
    million new cases of TB, of which 3.9 million were sputum smear
    positive (sputum smear positive TB cases affect the lungs, are the most
    infectious and therefore the most responsible for transmission of the
    disease (SS+) or ``infectious'' TB). In 2002, the global incidence rate
    (per capita) of TB was growing at a rate of 1.1 percent per year, and
    the number of cases was growing at 2.4 percent. Asia leads the world in
    terms of burden of TB--of the 22 high burden countries in the world
    today (accounting for 80 percent of the world TB cases), 11 are in
    Asia, including 4 out of the top 5, (India, China, Indonesia, and
    Bangladesh).
        The global resurgence of TB has been fueled by increasing HIV/AIDS
    prevalence, inadequate public health systems, and emerging resistance
    to anti-TB drugs. Persistent poverty, crowded living conditions, and
    delayed diagnosis and treatment contribute to transmission of the
    disease.
        TB threatens the poorest and most marginalized groups, disrupts the
    social fabric of society, and slows or undermines gains in economic
    development. An overwhelming 98 percent of the two million annual TB
    deaths--and 95 percent of the new TB cases each year--occur in
    developing countries. On average, TB causes three to four months of
    lost work time and lost earnings of 20-30 percent of household income.
    For families of persons who die from the disease, the impact of TB is
    even greater as about 15 years of income is lost due to premature
    death. In developing countries, the impact of TB on the family is even
    more important as TB generally afflicts the most economically active
    segment of the population between the ages of 15 and 54.

    Treating TB Through the Directly Observed Treatment, Short-Course
            (DOTS)
        Much progress has been made since The Stop TB Partnership (of which
    USAID is a member) was launched in 1998. The Amsterdam Ministerial
    Conference on Tuberculosis and Sustainable Development held in March
    2000 established global targets of 70 percent TB case detection and 85
    percent treatment success rates in SS+ pulmonary TB cases to be
    achieved by the year 2005 in the 22 High Burden Countries (HBCs). These
    countries together account for 80 percent of the world's estimated
    cases, and served to catalyze governments and donors to address TB.
        The Stop TB partners and countries have endorsed The Directly
    Observed Treatment, Short-Course strategy as the most effective
    strategy available for the treatment and control of TB. The DOTS
    Strategy has five components: Political commitment; passive case
    detection among patients seeking care at health facilities and
    diagnosis using sputum smear microscopy; standardized short-course
    treatment with direct observation of therapy at least in the initial
    phase; assurance of an uninterrupted supply of high quality drugs.
        The number of countries implementing DOTS increased from 112 in
    1998 to 180 in 2002 and one high burden country (Peru) reduced TB
    incidence sufficiently to graduate from the list of 22 HBCs. The
    Partnership has grown to include over 200 donors, nongovernmental
    organizations (NGOs) and other institutions, which demonstrates the
    strong global commitment to combat TB and to collaboration in that
    effort.
        However, recent analysis of global TB trends and progress in DOTS
    implementation indicates that without an acceleration of DOTS expansion
    and program strengthening, these global targets will not be achieved
    for many years to come. Reported global DOTS coverage of 69 percent
    masks the reality that many people, even in areas where DOTS is
    reportedly available, lack true access to DOTS. While the overall
    treatment success in DOTS areas is 82 percent (2001 cohort) about 31
    percent of the world's population resides in non-DOTS areas where
    treatment success averages just 40 percent.

    USAID's Response
        USAID currently supports programs to expand and strengthen DOTS in
    34 countries worldwide, including eight in Asia--Afghanistan,
    Bangladesh, Cambodia, Egypt, India, Indonesia, Pakistan and the
    Philippines. Illustrative activities supported in these countries
    include training of health personnel, strengthening of laboratory
    services and provision of laboratory equipment, development of
    guidelines and training materials, and technical assistance to
    strengthen program planning, monitoring, evaluation, and supervision.
        For example, in India, USAID has been a major supporter of the very
    successful national TB program--where DOTS coverage reached 71 percent
    of the population by the end of September 2003--774 million people. The
    death rate among TB patients nationally has dropped to less than 5
    percent. In Indonesia, which is another of USAID's major TB programs,
    USAID has provided critical support to the expansion of DOTS in two
    major provinces, and provided the technical support for the national TB
    program's implementation of a Global Fund grant for TB. In the
    Philippines, USAID is not only providing critical support to the
    national public sector TB program, contributing to a 10-percent
    increase in coverage but has pioneered an innovative private sector
    program. This program is designed to ensure that private sector
    services follow appropriate regimens and are coordinated with the
    public sector. This is critically important in a place like the
    Philippines, where people with TB symptoms are more likely to seek
    treatment from private providers than from the public sector.

    USAID's Technical Leadership
        In addition to our direct support for improving TB treatment
    programs at the country level, USAID also provides assistance to
    support DOTS programs worldwide through several global mechanisms and
    partners such as the STOP TB Partnership and the Global TB Drug
    Facility (GDF). USAID is actively involved in the STOP TB Partnership--
    the Agency is a member of the Partnership coordinating board and USAID
    technical personnel are members of all STOP TB technical working
    groups.
        The Agency provides funding and technical support to the GDF, and
    we are the second largest donor to the GDF. Since it was launched in
    2001, the GDF has raised and committed $39 million for grants for anti-
    TB drugs. Through the GDF and USAID's technical assistance programs
    countries and NGOs also receive technical assistance and training to
    strengthen the management of anti-TB drugs. They can also purchase
    anti-TB drugs through the GDF direct procurement mechanism, and
    therefore take advantage of the highly competitive pricing and good
    quality products that are available through the GDF.
        In this respect, the GDF is a perfect partner to the GFATM. Using
    funding provided by Global Fund grants for TB, countries and
    organizations can purchase TB drugs through the GDF direct procurement
    service.

    Battling Multi-Drug Resistance
        USAID is also working to address the problem of multi-drug
    resistant TB (MDR TB). We support country surveys to measure the
    magnitude of TB drug resistance as part of the on-going WHO/IUATLD
    Global Project on Anti-TB Drug Resistance Surveillance. To date, USAID
    has supported surveys in 15 countries or sites (including 3 provinces
    in China), with studies in 16 more countries ongoing or planned
    (including Indonesia and India). We also support an effective response
    to MDR TB by funding DOTS Plus for MDR TB pilot projects in a number of
    countries and settings, focusing on countries with the most serious MDR
    TB problem such as Russia (Orel and Ivanovo oblasts), and the Baltics
    (Latvia, Estonia, and Lithuania), and Kazakhstan. We provide funding to
    support the work of the STOP TB Green Light Committee (GLC). The GLC
    provides technical assistance and monitoring of DOTS Plus for MDR TB
    pilot projects. So far, the GLC has approved DOTS Plus pilot projects
    in 11 countries and another 14 applications are under review. DOTS plus
    projects that are approved by the GLC are eligible to purchase second-
    line anti-TB drugs at lower prices than on the open market. Finally, we
    support a network of supra-national reference laboratories that provide
    the necessary quality control for anti-TB drug susceptibility testing,
    and we are supporting training and operations research in hospital
    infection control to help reduce the risk of transmission of MDR TB in
    clinic or hospital settings.

    USAID and Global Fund Support
        USAID missions work closely with the Global Fund to Fight AIDS, TB
    and Malaria (GFATM) by leveraging mission funded programs with the
    substantial funding provided by the GFATM. USAID missions participate
    in the Country Coordinating Mechanisms, assist with grant proposal
    writing, and help countries prepare implementation and monitoring and
    evaluation plans for these grants. Through USAID technical partners
    such as the TBCTA and others, USAID missions provide support for
    technical assistance, capacity building and monitoring and evaluation
    to help the grant-recipient countries to effectively implement and
    manage GFATM grant-funded programs and activities. A total of $422
    million has been awarded to 21 countries in the ANE region for TB
    control.

    Investing in Disease Detection and Control
        Drug-resistant malaria and tuberculosis are just two examples of
    the many public health problems that exist in East Asia. However, the
    basic approaches just mentioned--including capacity building,
    partnerships, developing new tools--also apply to other infectious
    diseases as well. As you know, East Asia has been in the spotlight over
    the past few years with outbreaks of new diseases including SARS and
    bird flu. While their mortality has been relatively low compared to
    diseases such as HIV/AIDS, TB, and malaria, these new diseases have had
    a major economic impact on trade, tourism, and foreign investment.
    First-response organizations such as the World Health Organization and
    the U.S. HHS have been providing key support to track these epidemics
    and identify ways to limit their spread and impact. In addition,
    USAID's Office of Foreign Disaster Assistance has provided emergency
    assistance to affected countries. As part of longer-term development
    efforts, USAID is also working to strengthen human and institutional
    capacity in disease surveillance and response so that new diseases can
    be rapidly detected and stopped before they spread widely.

    Next Steps
        There is much to do. If we are to meet our goal of halving malaria
    by 2010, and of achieving global program targets for TB, all of us, our
    esteemed partners from Asian governments, health institutions and our
    global partners must act together through the opportunity offered by
    the Global Fund and through the Roll Back Malaria and Stop TB
    partnerships at all levels, most importantly in countries, to deliver
    the tools we have in hand, to develop new tools, and to fulfill the
    promise of coordinated and concerted support to countries.

        Senator Brownback. Thank you, Dr. Peterson. I will go
    through a series of questions, if I can, with you.
        Could you put that chart back up that showed the number of
    deaths by malaria just over a period of time? Did you get a
    chance to look at that or was it up too fast for you? Do those
    track with your trend lines? They may not be with the exact
    numbers, but do they track with your trend lines? Are we seeing
    a big increase in malaria infections and deaths in Africa?
        Dr. Peterson. I think those do track. In fact, in
    accordance with the worldwide eradication initiative, we truly
    hoped in the fifties and sixties that we would be able to
    eradicate malaria. We made huge progress, as you show, but the
    single intervention using one modality did not work. We were
    not able to completely eradicate malaria, and if you do not
    eradicate it completely, as we are seeing with polio right now,
    then it can begin to surge up again. So we could, and should,
    expect that if we do not continue to work at a communicable
    disease, we will see it come back.
        And what has happened is not just whether there has been
    spraying with DDT or not or whether it could have been
    completely eradicated. We were not successful in the fifties
    and sixties using only the insecticide.
        Senator Brownback. But you really drove that thing down.
        Dr. Peterson. We did.
        Senator Brownback. And let us get the South African chart
    up there. You tell me where the analysis is wrong on this.
    South Africa said, OK, I will agree with you, we will stop
    using DDT, we will go with your drug regime. Their deaths and
    incidence of malaria skyrocketed. They said, OK, we are backing
    away from this stuff and we are going to go back to what we
    know worked, which is, we are going to use DDT. We are going to
    use a particular set of drugs. A dramatic fall, a dramatic
    fall. It looks like to me we have tried this a couple of times.
    We pretty well do know what the silver set of bullets are. I
    mean, there are a couple of them here. They have got to be used
    in tandem, and used in tandem, you can drive those numbers down
    hard and fast. It just seems like we are not using the set
    strategy that we know will work.
        Dr. Peterson. What you will see in South Africa is that
    they use two strategies. They used DDT and an effective drug
    treatment. And that is really what we are talking about, that
    you need to use more than one strategy. The reason we were not
    successful in the fifties and sixties is we had a single
    intervention. What we realize now is that when we do treatment,
    we need, whenever we can, to use more than one drug at a time
    to stop drug resistance. In fact, that is where a lot of the
    upsurge has happened, because we have had developing drug
    resistance over the last 20 to 30 years.
        The issue is not: DDT or not DDT. It is: What is the most
    effective way to use insecticide to reach the greatest number
    of people? It can be DDT or it can be another insecticide, and
    it can be through spraying or it can be through bednets. They
    both have their place, and there are different reaches with the
    different modalities. The important thing is to be able to use
    the prevention strategies, the right one for the right place,
    and the treatment strategies and bring them both forward
    together in an integrated package.
        Senator Brownback. OK. Then why are we not doing that?
        Dr. Peterson. We are.
        Senator Brownback. Why are these numbers doing this on
    these other cases in Africa then? If we are doing it right, why
    are these numbers going up?
        Dr. Peterson. South Africa is a country with a small amount
    of malaria, mainly in circumscribed areas. It has a lot of
    funding itself, and it is using an integrated package. And it
    has done very nicely with a good push of resources and an
    integrated package to take care of a small epidemic.
        Other parts of Africa don't have the infrastructure to do
    national level indoor spraying, like South Africa has done, and
    they have much larger burdens of malaria in much more
    impoverished countries. So you are talking about a much greater
    scope of work in a country that has less capacity.
        So we are doing the right things and we are making a
    difference. We have seen in places where we have changed the
    drug treatment policy, where we are doing programs for
    treatment of pregnant women, that we can bring down the death
    rates and the impact on children. We do not have the resources
    to do programming in all of the countries at national scale.
    This is where you will begin to see a change as USAID funding
    has gone up in the last 4 years. That is a very short period of
    time.
        Senator Brownback. Well, it takes a year on this. You saw
    that South African program.
        Dr. Peterson. Yes.
        Senator Brownback. Let me ask you this very directly on it.
    You have got $80 million, is what you have said, in your
    budget. Does any of that go for indoor spraying of DDT?
        Dr. Peterson. Yes. We are supporting indoor spraying in
    five or six countries.
        Senator Brownback. Do you know how many dollars you are
    putting into that? And are you providing the money to buy the
    DDT? What are you providing?
        Dr. Peterson. Usually, we have been providing the training
    and the assistance for the programs to go forward. You have to
    train the people. You have got to provide the logistics systems
    and put it together with the rest of the program.
        Senator Brownback. Is that what you are funding then?
        Dr. Peterson. Yes.
        Senator Brownback. So you are not buying DDT.
        Dr. Peterson. To my understanding, we are not buying the
    DDT, but we generally work in partnership with the countries
    and with our local partners. So the Save the Children Program
    that I mentioned in Ethiopia was being funded by USAID, but we
    did not actually buy the DDT ourselves. But it did include
    indoor residual spraying with DDT. It has included bednets to
    50,000 women and children.
        Senator Brownback. Zambian health officials reported to my
    staff that they have repeatedly asked USAID for DDT funding for
    spraying and repeatedly been refused in that effort.
        I do not want this to be a gotcha hearing. What I want to
    do is work with you. I look at these numbers and they make me
    cry because this does not need to be this way. In the world
    today, if we were able to drive those numbers like that in the
    fifties and sixties, we know how to do this. I want to make
    sure if we move forward on this--and I think we will, and we
    have tried to get some additional funding in this appropriation
    bill for malaria. It would be nearly double what you have now--
    that we are not scared of DDT. I understand the problem. I come
    from a farm background. I am used to using pesticides. I
    understand both the good and the problem with it.
        The bednets I can see some usefulness, but also you cannot
    be under that net all night long. If you have got to get up and
    get around to get something or go to the bathroom, you are out
    from under the net. Mosquitoes are still around. I think it can
    work and be helpful.
        And we are getting complaints that we are not supporting
    the effective drug strategy, but rather we are supporting
    cheaper drug strategies on this.
        If we could, what is your breakdown of how the $80 million
    is being spent? Can you put it in categories for me or do you
    have that available to you now?

        [The information requested was submitted and has been made
    part of the committee's permanent record.]

        Dr. Peterson. I do not have that available. I can get it
    for you. I will say that it includes research in new malaria
    drugs, research on vaccines, the surveillance, the assistance
    in policy change, and we have been actively moving countries to
    the new drugs. It includes this partnership with the
    agricultural sector to grow more of the new drug so that the
    supply will be available as we scale up the programs. It
    includes the training of people to use new medicines, to know
    that they should be integrating it into their pregnancy
    programs, and to begin to put malaria programs into our HIV/
    AIDS programs. Those are the kinds of things that we are doing,
    including moving whole countries from a policy of one drug to
    the more effective combination drugs.
        As we look at the insecticide, we are not afraid of using
    the DDT. But it is very clear that there are places where it
    works better. If you are in an urban setting or a peri-urban
    setting where people are close together, it is much easier to
    go from house to house to house and do the spraying. But in the
    far rural reaches of any State in the United States or any
    country that we are talking about where people are spread out,
    then teams going from house to house, having to revisit houses
    because people are not home, takes more time, more money, and
    more teams to reach them. That is why having both modalities is
    so important. When you use the bednets, they can go out through
    normal commercial sector routes like Coca Cola, like flour and
    sugar go out, and it is available to the families where they
    can reach them. If we are relying on government sector
    infrastructure, it will work better in places where people live
    close together in areas where malaria is upsurging, where you
    go in for a short-term need.
        What we really need to do is have the flexibility to
    address the epidemic, as it is changing, and deal with each
    country's needs, which will be different. South Africa is very
    different than Zambia, than Uganda, or than Cambodia. And we
    need to bring all of the modalities, not limit ourselves to
    just one.
        Senator Brownback. Are you considering in your current
    funding that you have, purchasing DDT or direct purchases of
    DDT by your recipients to distribute it? Are you considering
    that in your expenditures right now?
        Dr. Peterson. We certainly can consider it. We also are a
    major funder of the Global Fund, and I sit on the Global Fund
    board. The moneys are going for malaria in all of these
    different countries, which as you pointed out, are purchasing
    DDT. They are also the major purchasers of the drugs
    themselves. That is U.S. dollars leveraging other donors to buy
    commodities and drugs. And so our bilateral programs really
    serve a unique purpose. When I meet with other donors, often
    U.S. Government--our bilateral programs are the only ones still
    providing technical assistance on policies, on how to make
    things happen, on how to get drugs from one place to another.
        Senator Brownback. So you are not considering it. You
    could, but you are not currently considering purchasing DDT by
    USAID funds.
        Dr. Peterson. We could consider it. I think the role that
    the U.S. Government is playing in our bilateral foreign aid
    programs is a special role. When we go and help countries get
    to the right policies or do the technical assistance----
        Senator Brownback. I understand that point. I am really
    trying to get to a narrow point here and then to understand why
    it is that you are not, when you acknowledge this is an
    effective strategy. It is a good strategy. It is part of the
    strategy, but we are not funding it. I want the other funds to
    do that and we are just going to provide technical assistance
    or bednets. If that is the deal, OK, that is the deal. I do not
    agree with it, but I just want to really try to understand why,
    when this is such an effective part of the strategy, we are not
    funding it.
        Dr. Peterson. Because, I think we have another mechanism
    that the United States is participating in, through the Global
    Fund and our other partnerships, that is set and ready to buy
    large amounts of commodities. What is unique about our
    bilateral programs that the other donors are not doing, is the
    assistance to make those programs work. The Global Fund is a
    financing institution and it is buying the commodities. Forty-
    five percent of what they are buying is commodities, including
    malaria treatments and DDT. They are having trouble making it
    work without our assistance.
        Senator Brownback. I understand that point and I appreciate
    it.
        I want you to know we are receiving complaints about that;
    that these countries do not want the sort of things that we are
    funding; that I am getting. We can provide you names. Here are
    people who are saying, ``look, I do not need another
    conference. I do not need another technician. I do not need
    another contractor. I need these drugs and this spray.'' They
    are willing to do it on their own in their distribution systems
    and the way they will go at it.
        Obviously, we were able to figure out in the past how you
    could get some of this stuff distributed, at least the sprays
    and some of the drugs, where we drove this thing down so hard,
    so fast, in the fifties and sixties where your distribution
    problems would have been infinitely more difficult than those
    now in more remote areas.
        I will look more at here, why we are just providing
    technical assistance in these areas rather than these items. I
    will look at it, and then maybe we need to respond here by
    saying, OK, then we need to fund the other programs rather than
    this one because that is where we actually get the delivery of
    the goods that the countries are asking for to actually drive
    the numbers down. And we can do that. We can go that route.
        Dr. Peterson. We have not heard these complaints from the
    countries. We would be very pleased to hear any specifics that
    you have. We try and always be responsive to the country's
    needs, their decisions, and the route that they would want to
    go.
        I often get ministers of health or ministries saying,
    please, would you just give the government the money or just
    buy us this. And when I say, well, does that mean you do not
    want this group providing this technical assistance to help you
    with your policies, they say, oh, no, no, we do want that and
    you are the only one still providing it for us. So I am happy
    to respond to specific country issues, but I often find that
    when they have to have a choice between what we are currently
    providing and something else, what they really want is both.
        Senator Brownback. I would like, if you would, for you to
    provide to the committee your breakdown of how you are spending
    the current allocation of funds.
        I appreciated your hitting on tuberculosis. At another
    time, I would like to catch you more on other disease issues in
    developing countries and get from you your list of top five,
    top ten. I think we are hitting pretty hard the HIV/AIDS issue
    and are starting to be effective, and we are putting in
    billions on that. We have really stepped up. The
    administration, the President, has pushed this. It has been a
    great initiative. So they are really hitting strong.
        My focus is to say, OK, what is the next level of issues
    that are there that we have not effectively addressed and we
    have not put near the focus on and let us start looking at that
    series of items. So we would like it if you could provide, when
    you get back, your top five or ten. Here are the ones that I am
    most concerned about and they do not gather as many headlines.
        Do you have on the top of your head on what you focus on
    your top three or four that you believe, OK, these are the
    ones, if you would give me resources, that I would focus on?
        Dr. Peterson. AIDS, TB, and malaria are sort of the ones
    that have captured most of the attention, and we have touched
    on malaria and a little bit on TB today. But I think the
    equivalent area like malaria and TB, where we were making some
    great progress and have not done so well in the past, probably
    because we are focused on these other three diseases, is the
    child survival package of interventions. We still have 11
    million children who die every year, and we could prevent
    probably two-thirds of them. We could prevent almost 7 million
    deaths. Malaria is one of the big killers within that group,
    but it is also diarrhea, pneumonia, malnutrition, and the
    vaccine-preventable diseases. Those are all things that we are
    working on but we are not making progress anymore. They are
    cheap. We know what works and we just need to do them at scale.
    So child survival is an area to balance with AIDS, TB, and
    malaria priorities. We talk a lot about HIV/AIDS, but in fact,
    it is the children who are orphaned by AIDS who are now dying
    of malnutrition and pneumonia and malaria because they are the
    most impoverished with the least access to the services. So
    that is my number one area of concern.
        And within each country, it is a little different spectrum
    of what their needs are for that country. Cambodia is different
    than Ethiopia, two of the top countries for child survival
    problems. But that would be my other one, packaging the
    priority interventions by country needs.
        Senator Brownback. Well, thank you very much. If you have a
    chance, I would appreciate it--and I do not know if you can--if
    you would stick around to hear, at least, the presentation of
    the next two presenters. I think they are pretty thoughtful on
    this. Hopefully then, we will all be able to work together
    toward what we can see as effective strategy. I do appreciate
    both your public and private service because you have done this
    before in a private setting, and I appreciate that and I
    appreciate your doing it in a public setting.
        Dr. Peterson. Thank you very much.
        Senator Brownback. Thank you.
        The second panel will be Dr. Donald Roberts and Dr. Robert
    Desowitz. Dr. Roberts is a professor of tropical health at the
    Uniformed Services University for the Health Sciences. He has
    conducted extensive international research on malaria. He
    currently operates an NIH-funded research program focusing on
    developing chemicals to replace DDT for preventing the spread
    of malaria.
        Dr. Robert Desowitz is a renowned researcher, lecturer, and
    professor. He has published numerous books and articles,
    including ``The Malaria Capers: Tales of Parasites and
    People.'' Dr. Desowitz has held faculty positions at
    universities around the world, including Singapore and Nigeria.
    He is currently professor emeritus of tropical medicines and
    medical microbiology at the University of Hawaii, and an
    adjunct professor of epidemiology at the University of North
    Carolina at Chapel Hill.
        I am delighted, gentlemen, that both of you could be here
    to join us today with your expertise and background. I
    appreciate your testimony. Your written statement will be
    included in the record. If you would like to summarize, that
    would be fine. So, whatever route you would like to take. Dr.
    Roberts, let us start with you.

       STATEMENT OF DR. DONALD ROBERTS, PROFESSOR, DEPARTMENT OF
        PREVENTIVE MEDICINE AND BIOMETRICS, UNIFORMED SERVICES,
              UNIVERSITY OF HEALTH SCIENCES, BETHESDA, MD

        Dr. Roberts. Thank you, Chairman Brownback, for the
    opportunity to present my views on malaria control today.
        Asia does not present us with the worst of malaria control
    problems, but this does not mean that there are no problems of
    malaria control in Asia. As you will see in my written
    testimony, conditions in many Asian countries are far worse
    today than they were decades ago when a systematic approach to
    indoor spraying of insecticides was used to combat malaria. The
    return of malaria to the country of South Korea is symbolic of
    the reversals that have occurred in the global strategy to
    control malaria. However, the malaria problem in South Korea is
    more than symbolic. There were 115,000 cases in North Korea in
    2001, and malaria now poses a risk to our military.
        The malaria control community around the world is presently
    locked into several different debates on best practices for
    dealing with a continuing and, in some areas, a worsening
    problem of a very preventable disease, which is the topic of
    today's meeting, and that is malaria. One part of the debate is
    whether to use insecticide-treated nets as the only preventive
    measure or to use nets and indoor spraying of small quantities
    of insecticide on house walls. Real differences exist between
    these methods. Nets protect only those under the nets, whereas
    indoor spraying protects all within the household 7/24. The
    option of using one or the other is an important debate. If the
    decision is to go with nets alone, then public funds will
    continue to be used to pressure countries to abandon their uses
    of indoor spraying.
        In a larger context, I am surprised that we have this
    debate at all. There is no scientific basis for stopping or
    preventing indoor spraying. On the contrary, replacing indoor
    spraying with nets defies a fundamental lesson of preventive
    medicine. Clearly delineated within the annals of occupational
    preventive medicine is the fundamental truth that the least
    desirable preventive measure for reducing environmental risk is
    reliance on personal protective measures. We have certainly
    learned this lesson over and over again in the military. This
    principle is expressed in the form of patients failing to take
    a full course of drugs, failure of troops to properly wear
    uniforms to prevent insect bites, or failure to properly apply
    topical repellents, or failure to use their bednets.
        It is also a fundamental truth that proper use of nets
    requires user compliance. The user must be educated on the
    proper use and must then be highly disciplined in proper use
    night after night. Additionally, the user must be conscientious
    and follow a routine of repairing those nets and retreating
    those nets with insecticides. If we could be certain that there
    would be full and proper user compliance, we would still need
    to determine whether the practice would truly deliver a
    meaningful level of disease prevention. Let me present one
    single study to illustrate why we should worry about that
    specific issue.
        A bednet study was conducted in the small and highly
    malarious Phan Tien village in southern Vietnam from 1995 to
    1999. Case treatment and net use was supervised and monitored.
    Malaria was reduced but rose again in the last year. The
    investigators stated that after malaria was reduced, the
    population lost interest in the intervention. Basically after 5
    years of costly effort, malaria in the last year had declined
    only 2 percent from numbers of cases in the beginning year.
    While this is not the best that we can expect, it certainly
    indicates that in the long term disease prevention can be very
    low indeed.
        To repeat, the fundamental lessons of occupational
    preventive medicine is that use of personal protective measures
    is the least desirable of methods for reducing environmental
    risk. The flip side of this principle is that the most
    desirable method for reducing environmental risk is to engineer
    risk out of the human environment. The use of indoor spraying
    is absolutely consistent with that fundamental principle of
    preventive medicine, and let me explain why.
        Most cases of malaria are acquired inside houses.
    Mosquitoes that aggressively enter and bite indoors transmit
    the infections. Indoor residual spraying can act to prevent
    mosquitoes from entering houses in the first place. If they
    still enter, then chemical contact indoors can cause the
    mosquitoes to exit without biting. If they remain indoors, the
    chemical can, with longer contact, kill the mosquitoes. In
    other words, the chemical applied to house walls exerts
    multiple and sequential actions to prevent indoor transmission
    of malaria and other diseases.
        These relationships explain why indoor spraying has been so
    wonderfully effective in combating malaria and other diseases.
    I want to emphasize that lack of effectiveness is not the
    reason that the World Health Organization and bilateral and
    multilateral donors have pressed countries to stop spraying
    programs. To the contrary, indoor spraying has been and
    continues to be the most highly effective preventive measure
    yet discovered for preventing malaria.
        WHO, USAID, and others argue that spraying should not be
    used because it requires a strong and well-developed public
    health infrastructure. I would respond to that assessment by
    saying that spraying was used to reduce or eliminate malaria in
    many countries of the world long before WHO defined the
    organizational structures needed for indoor spraying programs.
    The countries accomplished these great achievements on their
    own. I can think of two remarkable examples. One is Guyana and
    another is Taiwan. Guyana began experimenting with indoor
    spraying in 1946. In that year, the country instituted a
    national program of spraying and reduced their malaria problems
    by 99 percent in 3 years, and they used no therapeutic drugs.
    Malaria treatments were not part of that program. Taiwan began
    a national program in 1952 and had reduced numbers of cases
    from 1.2 million cases to 676 in 1956. In comparison, during
    the last 20 years, treated nets have been pilot tested in many,
    many countries. There is not one result from those studies that
    can compare with the performance of indoor spraying of DDT in
    Guyana or Taiwan.
        The statement was made earlier that countries have failed
    to protect their populations, and for that, they need to have
    training and encouragement to do so. The fact is that many of
    these countries have been pressured to stop those programs, and
    your graph shows the results of the pressures to change those
    programs.
        To sum up my oral testimony, during the last 24 years, many
    developing countries have been pressed to stop programs of
    indoor spraying due to an environmental ideology that strives
    for an environmental utopia, an environment free of manmade
    chemicals. This ideology is strong and pervasive. It
    prioritizes scientifically unfounded risk of environmental harm
    over the basic health needs of the world's poorest and most
    vulnerable people. Countries need the freedom to return to the
    use of indoor spraying if they so desire. Today, due to
    pressure from WHO and bilateral and multilateral donors,
    developing countries really do not have that freedom.
        Thank you.
        [The prepared statement of Dr. Roberts follows:]

    Prepared Statement by Donald R. Roberts, Ph.D., Professor, Division of
         Tropical Public Health, Department of Preventive Medicine and
      Biometrics, Uniformed Services, University of the Health Sciences,
                                  Bethesda, MD

        Thank you Chairman Brownback and members of the Subcommittee on
    East Asian and Pacific Affairs for the opportunity to present my views
    on malaria control.
        Asia does not present us with the worst of malaria control
    problems; but this does not mean that there are no problems of malaria
    control in Asia. Conditions in many Asian countries are far worse today
    than they were decades ago when insecticides were sprayed on house
    walls to combat malaria. The return of malaria to the countries of
    North Korea and South Korea is symbolic of the reversals that have
    occurred.\1\ However the malaria problem in South Korea is much more
    than symbolic, 115,000 cases of malaria occurred in North Korea in
    2001,\2\ and malaria along the demilitarized zone now poses a risk to
    U.S. military personnel.
    ---------------------------------------------------------------------------
        \1\ ProMed Notice ``Malaria Reemerges-Korea,'' http://
    www.tmd.ac.jp/med/mzoo/ProMed/
    971118.html. Also: Ree, HI. Unstable vivax malaria in Korea. Korean J
    Parasitology 38(3):119-138.
        \2\ Malaria profile DPR Korea, http://w3.whosea.org/malaria/
    profile-dprk.htm.
    ---------------------------------------------------------------------------
        Today, the malaria control community around the world is locked
    into several different debates on best practices for dealing with
    continuing and, in some areas, worsening malaria problems.\3\ One part
    of the debate is efficacy of different preventive measures, and this
    debate narrows to the issue of whether to use insecticide treated nets
    as the only preventive measure or whether to open the field to both the
    use of insecticide treated nets and indoor spraying of small quantities
    of insecticide on house walls. This is an important debate, because if
    the decision is to go with the former approach, then aid agencies will
    continue to use public funds to press countries to abandon their uses
    of indoor spraying to control malaria.
    ---------------------------------------------------------------------------
        \3\ Attaran and Maharaj. Ethical debate: doctoring malaria, badly:
    the global campaign to ban DDT.BMJ. 2000 Dec 2; 321 (7273):1403-5.
    ---------------------------------------------------------------------------
        To gain a historical perspective, if we were to look from our 2004
    vantage point back over the history of global strategies to control
    malaria, we would see a period of failure followed by a period of great
    success followed by a period of failure.
        The first period covers the years before the mid-1940s. In this
    era, public health officials tried many methods of malaria control.
    Most of these methods failed, and malaria remained largely unabated.
    The second period, the era of intensive household spraying programs,
    came after the mid-1940s. Health officials sprayed small quantities of
    DDT on the interior walls of a house, a process known as indoor
    residual spraying (IRS). To contrast the small quantity on walls with
    agricultural usage, the amount used on just ten acres of cotton during
    a growing season would be sufficient for spraying enough houses to
    protect 4,500 people. Additionally, agricultural use puts the chemical
    directly into the environment and the food chain. When used in malaria
    control, the chemical is put only on house walls.
        House spraying controlled malaria and even eradicated it in some
    regions. The period of spraying and its intensive control of malaria
    lasted for about 33 years, ending in 1979. In 1979, the World Health
    Organization strategy for malaria control changed to de-emphasize
    indoor spraying.\4\ In 1985 WHO further distanced itself from indoor
    spraying in a World Health Assembly resolution (38.24) that directed
    countries to decentralize malaria control programs.\5\ Those changes in
    global strategies brought most effective spraying programs to an end.
    Instead of spraying, WHO and donors like USAID place an emphasis on
    case treatment, community participation, and integrated vector
    management.\6\ This modem strategy for malaria control has failed.\7\
    Since the startup of the ``Roll Back Malaria'' initiative in 1985,
    malaria rates have actually increased.\8\
    ---------------------------------------------------------------------------
        \4\ Seventeenth Report, WHO Expert Committee on Malaria. WHO Tech.
    Rep. Ser. No. 640 (1979).
        \5\ H. Gilles, D. Warrell, Bruce-Chwatts' essential malariology.
    Edward Arnold, Boston (1993).
        \6\ Implementation of the global malaria control strategy. WHO
    Tech. Rep. Ser. 1993, no. 839 (1993).
        \7\ http://www.rbm.who.int/amd2003/amr2003/chl.htm.
        \8\ G. Yamey. British Medical Journal: Roll Back Malaria: a failing
    global health campaign.
    8 May 2004: http://www.accessmed-msf.org/prod/
    publications.asp?scntid=13520041552454
    &contenttype=PARA&.
    ---------------------------------------------------------------------------
        In contrast to the results of WHO's current malaria control
    strategy, results with indoor spraying, and especially spraying with
    DDT, were spectacular. Almost without exception, when DDT was sprayed
    on interior house walls, it rapidly brought malaria rates down or
    completely eradicated the disease.
        Just as the use of DDT in house spraying brought spectacular
    reductions in malaria, declining use of house spraying brought
    spectacular increases in malaria.\9\ Data from countries of the
    Americas clearly document changes in malaria rates that coincide with
    changes in house spraying rates (Figure 1). Data \10\ from Asian
    countries show similar relationships. Figures 2-5 contrast malaria
    rates in recent years with the years when DDT was used. The data
    represent annual parasite indexes (a population-based index of malaria
    prevalence) during the period from 1995-99 compared with identical data
    from 1965-69. Differences in rates for the two performance periods are
    stunning.
    ---------------------------------------------------------------------------
        \9\ D. Roberts, et al., DDT, global strategies, and a malaria
    control crisis in South America. Emerg. Inf. Dis. 3:297 (1997). Also:
    Roberts, Manguin, Mouchet. 2000. DDT house spraying and re-emerging
    malaria. Lancet 356:330-332.
        \10\ Data presented in graphs were extracted from WHO reports: WHO,
    malaria profile:
    http://w3.whosea.org/malaria/pdf/ino.pdf.

        Today, out of 30 countries in Asia, Bhutan, Myanmar, and Sri Lanka
    are the three most malarious.\12\ In Bhutan, the malaria burden has
    grown 17.5-fold since the period when DDT was sprayed on house walls.
    For the countries of Myanmar, Sri Lanka, and India, malaria rates have
    grown 6.7-, 6.4-, and 807-fold, respectively.
    ---------------------------------------------------------------------------
        \11\ Data extracted from: PAHO reports ``Status of Malaria In the
    Americas.'' Calculations of numbers of cases derived by standardizing
    slide positive rates per 1000 population according to a standardized
    annual blood examination rate. Standardized rate was calculated as
    average for each country during period of 1965 to 1979. Adjustments
    were made for differences in size of population across 5 countries.
        \12\ Malaria rate by country: http://www.overpopulation.com/faq/
    health/infectious_diseases/malaria/asia.html.
        \13\ Data presented in graphs were extracted from WHO reports: WHO,
    malaria profile:
    http://w3.whosea.org/malaria/pdf/ino.pdf.

        WHO, however, touts one Asian country as a success story of its
    modem malaria control strategy, Vietnam. A WHO report \15\ entitled ``A
    Story to Be Shared: The Successful Fight Against Malaria in Vietnam''
    recounts the story of this success. The report describes Vietnam's
    transition from a program based on indoor spraying using DDT to a
    program of spraying with Icon (a pyrethroid) and treated nets, as well
    as changes in strategies of case detection and case treatment. If this
    is the success story that is the basis for USAID's and WHO's current
    strategies for malaria control, they need to re-evaluate the lessons
    this story teaches.
    ---------------------------------------------------------------------------
        \14\ Data presented in graphs were extracted from WHO reports: WHO,
    malaria profile:
    http://w3.whosea.org/malaria/pdf/ino.pdf.
        \15\ WHO WPRO. 2000. A Story to be Shared: The Successful Fight
    Against Malaria in Vietnam. l5pp.
    ---------------------------------------------------------------------------
        The story begins in 1991, when over a million cases of malaria
    occurred in Vietnam, and ends in 1999, when the number of cases of
    malaria dropped to under 400,000. The report's overview states that the
    government completely changed the malaria control strategy in 1991 away
    from use of DDT, implying that this was a voluntary change. In fact, I
    visited Vietnam's control program in the early 1990s. Government
    officials told me that they wanted to use DDT, because it still worked
    well in Vietnam, but Vietnam had long ago used most of its DDT stocks.
    The government had been trying to get DDT for several years. However
    international agencies and foreign donors refused to help the
    government make those purchases. Vietnam didn't choose to switch to
    another insecticide. It had no choice but to switch. I have heard this
    same story of international agencies and donors like USAID blocking use
    of DDT in country after country, in both Asia and the Americas.
        Despite its unwilling switch, Vietnam did have significant
    reductions in malaria between 1991-1999, brought about by the use of
    indoor spraying, effective case treatment, and the use of treated nets.
    When indoor spraying is used, malaria cases drop immediately, which is
    fortunate as the use of nets grew slowly in Vietnam. The costs of the
    program however skyrocketed. In 1991, malaria control cost US$540,000.
    From then to 1999, the malaria program cost US$28 million (about US$3.5
    million per year), and it didn't yield as large a decline in malaria
    cases as control programs had in the past. In earlier years when the
    country carried out DDT spraying, malaria declined by a factor of 20-
    fold (2000%) in the north and 4-fold in the south. In 1999, Vietnam
    reported 350,000 cases, representing a 2.9-fold decline from number of
    cases in 1991. In areas where malaria is brought under control, treated
    nets are the primary preventive measure. House spraying remains the
    primary means of control in remote areas, areas of persistent malaria,
    and in outbreak areas. Although Vietnam has enjoyed some success, the
    350,000 cases in 1999 represents a lot of malaria, making Vietnam the
    fourth most malarious country in Asia.\16\
    ---------------------------------------------------------------------------
        \16\ Malaria rate by country: http://www.overpopulation.com/faq/
    health/infectious_diseases/malaria/asia.html.
    ---------------------------------------------------------------------------
        WHO and others seem to overlook the fact that effectiveness of the
    Vietnam system seems dependent on the authoritarian rule of a socialist
    system and its extensive network of rural communes. The report states
    that once a year re-treatment of nets is not adequate and nets must be
    retreated every 6 months, which requires an extensive network of
    trained malaria control workers. Additionally, Vietnam workers declared
    in ``final words of wisdom'' that control requires a strong national
    program, one with a dedicated team, a high level of support and a fair
    amount of vertically controlled components. Ironically, WHO has worked
    diligently to eliminate the vertical components of malaria control
    programs, going so far as to direct countries to eliminate those
    infrastructures,\17\ which Vietnam thinks were so critical to its
    success.
    ---------------------------------------------------------------------------
        \17\ World Health Assembly adopted resolution 38.24 in 1985 calling
    on countries to decentralize their malaria control programs by moving
    malaria control into primary health care systems.
    ---------------------------------------------------------------------------
        It is in fact quite peculiar that WHO and aid agencies such as
    USAID tout Vietnam's control effort as such a success story. The
    program bucks WHO policy in that house spraying remained a key part of
    control and the community participation, which WHO considers such a
    triumph, was not the result of the spontaneous embrace of the people,
    but rather directed by a strong centralized, authoritarian government.
        Vietnam however is not the only country in Asia to control malaria.
    Thailand, a nearby country with similar vectors, environments, and
    malaria problems, has not embraced treated nets and community
    participation to the extent as has Vietnam. Indoor spraying remains, as
    it has for decades, the mainstay of Thailand's preventive measures. In
    1999, out of the 30 Asian countries, Thailand was the 11th most
    malarious country in Asia; Vietnam was the 4th. Yet even though
    Thailand has similar conditions and far lower malaria rates \18\ than
    Vietnam and has consistently maintained those lower rates for decades
    (see Figure 6, malaria rates for the comparison periods of 1995-99 and
    1965-69), WHO and other aid agencies consider Vietnam the success story
    in Asia, not Thailand.
    ---------------------------------------------------------------------------
        \18\ WHO, malaria profile: http://w3.whosea.org/malaria/pdf/
    ino.pdf.

        Since the shift in malaria control policies that began in 1979
    occurred, malaria has increased greatly in countries outside Africa
    (see Figures 1-5). In Africa, which had been excluded from the malaria
    eradication campaign of the l950s and 60s, there is almost no evidence
    that malaria rates are changing for the better as a result of
    implementing the WHO program of case treatment, community
    participation, integrated vector management, and treated nets, but not
    indoor spraying.\19\ On the other hand, countries in Africa that have
    gone against WHO doctrine and used indoor spraying, such as Madagascar
    \20\ and Zambia,\21\ have seen large declines in malaria rates.
    ---------------------------------------------------------------------------
        \19\ G. Yamey. British Medical Journal: Roll Back Malaria: a
    failing global health campaign. 8 May 2004: http://www.accessmed-
    msf.org/prod/publications.asp?scntid=13520041552454
    &contenttype=PARA&.
        \20\ Description of DDT use in Madagascar described on the Malaria
    Foundation International website: http://www.malaria.org/
    DDTEconomist14_XII_00.html.
        \21\ Sharp, et al. (2002), ``Malaria control by residual
    insecticide spraying in Chingola and Chililabombwe, Copperbelt
    Province, Zambia'' Tropical Medicine and International Health, 7, no.
    9:732-36.
    ---------------------------------------------------------------------------
        One fascinating aspect of attempts to implement WHO's current
    strategy for malaria control is that countries of Africa are the focal
    point of these efforts. This is doubtless due to Africa having the
    worst malaria problems in the world.\22\ These countries were excluded
    from global eradication efforts and so have had limited experience
    successfully controlling their malaria problems. In this regard African
    nations are unlike many countries in the Americas and Asia that enjoyed
    high levels of success during the eradication era. Curiously countries
    that have had more experience with successful malaria control are less
    likely to adopt the use of treated nets. The Pan American Health
    Organization, for example, won't recommend them for malaria control in
    the Americas. Although donors provide generous funds for net use, nets
    are only now gaining a foothold in control programs outside Africa. As
    this occurs, the countries of Africa, frustrated by their continuing
    high malaria rates, are expressing interest in using indoor spraying.
    ---------------------------------------------------------------------------
        \22\ Ranking of countries by malaria mortality: http://
    www.overpopulation.com/faq/health/infectious_diseases/malaria/
    asia.html.
    ---------------------------------------------------------------------------
        As I stated at the beginning of this testimony, a large part of the
    debate about best practices for preventing malaria is whether to use
    insecticide treated nets as the only preventive measure or whether to
    open the field to both the use of insecticide treated nets and the
    indoor spraying of small quantities of insecticide on house walls.
    Frankly, I am surprised that we are having this debate at all. There is
    no scientific basis for stopping or preventing indoor spraying of
    insecticides. On the contrary, replacing spraying with nets defies a
    fundamental lesson of preventive medicine.
        Clearly delineated within the annals of occupational preventive
    medicine is the fundamental truth that the least desirable preventive
    measure for reducing environmental risk is reliance on personal
    protective measures.\23\ We have certainly learned this lesson over and
    over again in the military. This principle is expressed in the form of
    patients failing to take a full course of drugs, failure of troops to
    wear uniforms properly to prevent insects from biting, or failure to
    properly apply topical repellents, or failure to use their bednets.
    ---------------------------------------------------------------------------
        \23\ Rom, WN. Editor. Environmental and Occupational Medicine,
    Third Edition. Lippincott-Raven Publishers, Philadelphia, PA:1753-1755.
    Also: Olishifaki, JB, Editor-in-Chief. Fundamental of Industrial
    Hygiene, Second Edition. National Safety Council. Section on
    Fundamental Concepts, pages 35-39.
    ---------------------------------------------------------------------------
        It is a fundamental fact that proper use of nets requires user
    compliance. The user must be educated into proper use and must then be
    highly disciplined in proper use, night after night after night.
    Additionally, the user must be conscientious and follow a routine of
    repairing nets and retreating nets with insecticides. Another
    fundamental aspect of personal protective measure is that the measure
    may not lower overall environmental risk. For example, placing infants
    or pregnant women under treated nets may do little to lower risk for
    others in the household. For these reasons, even if we were certain of
    full user compliance, we would still need to be certain the practice
    would truly deliver a meaningful level of disease prevention. This is
    an important question, and I will present one single study to
    illustrate why we should worry about that specific issue opposed to
    blanket acceptance of treated nets as the only approach to malaria
    prevention.
        A bednet study was conducted in the small and highly malarious Phan
    Tien village in southern Vietnam from 1995 to 1999.\24\ Case treatment
    and treated net use was closely supervised and tightly monitored.
    Malaria was reduced, but, as stated by the investigators, ``The number
    of passive cases [cases coming to the clinic for diagnosis and
    treatment] had dropped steadily from year to year (despite an increase
    in population), but rose again in 1999.'' The investigators also stated
    ``After 1997, when malaria incidence had started to decline, the
    population became less interested in participating.'' This is a very
    telling statement that confirms the weakness of methods that require
    sustained user compliance. My summary of this study is that at the
    beginning in 1995 there were 104 cases of falciparum malaria, in the
    last year of the study, in 1999, there were 102 cases. So, after five
    years of costly effort, there had been a 2 percent drop in falciparum
    malaria, a difference of 104 cases versus 102.
    ---------------------------------------------------------------------------
        \24\ Hung, LQ, et al., Control of malaria: a successful experience
    from Vietnam. Bulletin of the World Health Organization 2002;80:660-
    666.
    ---------------------------------------------------------------------------
        To iterate, the fundamental lessons of occupational preventive
    medicine is that use of personal protective measures is the least
    desirable of methods for reducing environmental risk. The flip side of
    this principle is that the most desirable method for reducing
    environmental risk is to engineer risk out of the human
    environment.\25\ The use of indoor spraying is absolutely consistent
    with that fundamental principle of preventive medicine. Let me explain
    why.
    ---------------------------------------------------------------------------
        \25\ Rom, WN. Editor. Environmental and Occupational Medicine,
    Third Edition. Lippincott-Raven Publishers, Philadelphia, PA:1753-1755.
    Also: Olishifaki, JB, Editor-in-Chief. Fundamental of Industrial
    Hygiene, Second Edition. National Safety Council. Section on
    Fundamental Concepts, pages 35-39.
    ---------------------------------------------------------------------------
        Most cases of malaria are acquired inside houses. Mosquitoes that
    aggressively enter and bite indoors transmit the infections. Indoor
    residual spraying can act to prevent mosquitoes from entering houses in
    the first place. If they still enter, then chemical contact indoors may
    stimulate mosquitoes to exit without biting, or if they remain indoors,
    the chemical can, with longer contact, kill the mosquitoes. In other
    words, the chemical applied to house walls exerts multiple and
    sequential actions to prevent indoor transmission of malaria and other
    diseases.\26\
    ---------------------------------------------------------------------------
        \26\ Roberts, DR, et al., 2000. A probability model of vector
    behavior: Effects of DDT repellency, irritancy and toxicity in malaria
    control. J. Vector Ecol. 25(l):48-61.
    ---------------------------------------------------------------------------
        These relationships explain why indoor spraying has been so
    wonderfully effective in combating malaria and other diseases. I want
    to emphasize that lack of effectiveness is not the reason that WHO and
    bilateral and multilateral donors have pressed countries to stop indoor
    spraying. To the contrary, indoor spraying has been and continues to be
    the most highly effective measure yet discovered for malaria
    prevention. WHO, USAID and others argue that indoor spraying should not
    be used because it requires a strong and well-developed public health
    infrastructure. This is a contrived argument that ignores the lessons
    from the history of malaria control. House spraying was used to
    dramatically reduce malaria in many countries of the world long before
    WHO defined the organizational structures for malaria eradication by
    use of indoor spraying. The countries accomplished those great
    achievements largely on their own accord. I can think of two remarkable
    examples, one is Guyana and another is Taiwan. Guyana began
    experimenting with indoor spraying in 1946. The country quickly
    instituted a national program of indoor spraying and reduced malaria by
    99 percent within 3 years.\27\ Taiwan began a national program in 1952
    and had reduced numbers of cases from 1.2 million per year to just 676
    in 1956.\28\ These accomplishments predated the beginning of malaria
    eradication. In comparison, during the last 20 years treated nets have
    been pilot tested in many countries. There is not one result that is
    even remotely comparable with the performance of indoor spraying in
    Guyana or Taiwan.
    ---------------------------------------------------------------------------
        \27\ Giglioli, G. 1951. Eradication of Anopheles darlingi from the
    inhabited areas of British Guiana by DDT residual spraying. J. National
    Mal. Soc. 10:142-161.
        \28\ Department of Health, Republic of China, Malaria eradication
    in Taiwan (Department of Health, Republic of China), p. 183.
    ---------------------------------------------------------------------------
        The infrastructure argument against indoor spraying also ignores
    the fact that WHO, bilateral, and multilateral agencies have
    implemented policies and strategies under a 1985 WHA resolution that
    have effectively eliminated infrastructures they claim are needed for
    indoor spraying. So it is extremely disingenuous to say a method cannot
    be used because infrastructure does not exist, when those who oppose
    using the method are directly responsible for eliminating the needed
    infrastructures in the first place.
        What I have described in the preceding text and figures is a
    struggle between public health science and an environmental ideology.
    It is an ideology that strives for an environmental utopia, an
    environment free of man-made chemicals. The ideology is strong,
    pervasive and extremely destructive. It prioritizes a scientifically
    unfounded risk of environmental harm over the basic health needs of the
    world's poorest and most vulnerable people. As the driving force behind
    the modern policies for malaria control, it ignores the time honored
    practice of malaria control to use all available measures to curb the
    disease, and replaces it instead with partial control measures adopted
    because they are apparently more palatable to those living in developed
    countries. Our national and international bureaucracies put this
    ideology over the needs of poor people in developing countries. I,
    along with many others in the malaria control community, do not agree
    with this ideology. This ideology has created a colossal public health
    and humanitarian disaster. In particular, we object to the use of
    public funds to pressure developing countries to comply with policies
    and strategies that increase the risk of disease and death. It is an
    irrefutable fact that for over two decades WHO, bilateral and
    multilateral donors, and other international agencies have been
    pressing countries to abandon indoor spray programs. The world has
    already paid an enormous price in lost life, lost economic vitality,
    and lost human welfare as a result of those practices. It is time to
    stop this flagrant use of public funds to force compliance with a
    scientifically fraudulent and immoral ideology.

        Senator Brownback. Thank you, Dr. Roberts. I look forward
    to questioning.
        Dr. Desowitz, thank you for being here and your years of
    service. In reading your resume and background, that is quite
    impressive.

        STATEMENT OF DR. ROBERT DESOWITZ, ADJUNCT PROFESSOR OF
      EPIDEMIOLOGY, SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF NORTH
                       CAROLINA, CHAPEL HILL, NC

        Dr. Desowitz. Thank you, Senator Brownback. Welcome to our
    magic circle of malariologists. [Laughter.]
        I think everything I wanted to say has already been said,
    but I will begin with the conventional malariological plea that
    there is a carnage every year of 2 million to 3 million
    children and pregnant women. This is usually followed by ``send
    more money.''
        I would depart from that in expressing my feeling that for
    the last 50 years, no child, no pregnant woman, no transmigrant
    need have died of malaria. We disparage the pharmaceutical
    industry for not being attentive to Third World needs, but in
    actual fact we have had therapeutic drugs that could cure each
    and every malarious person, again for the last 50 years, or if
    you want to look in the longer perspective, practically for the
    last 400 years, with quinine always being the bulwark.
        Today, there is present a number of therapies that act
    quickly, they act effectively, and they will act against
    multidrug-resistant strains of falciparum, the killer malaria.
    Foremost of those drugs is Coartem. This is a modern drug that
    is 2,000 years old, as you know. It is an extract of Artemisia
    annua, the sweet wormwood; China, I think first used for
    hemorrhoids 2,000 years ago, but it seems to be better for
    malaria. [Laughter.]
        It is produced extensively in China.
        A late-night thought occurred to me that--I think it was in
    part of the debate the other night where they were talking
    about Afghanistan and opium poppy growing--Artemisia would be a
    marvelous replacement crop for that.
        Senator Brownback. There is a good idea.
        Dr. Desowitz. Actually there is only one drug that is being
    used now, and this is a drug put together by Novartis. It is
    called Coartem and it is a combination of artemisinin, which
    acts very quickly but has a very short half-life, and a drug
    called lumefantrine, which is terrific. It sort of mops up the
    rest of the parasites. Coartem, as far as I know, is the only
    one of the combined artemisinin therapeutics that is
    commercially available and standardized. It is produced by
    Novartis.
        Now, Novartis is selling Coartem. If you go to your
    friendly Swiss drugstore, it is $52. You might get it at your
    friendly Swiss Wal-Mart, if there is such a thing, for maybe
    $30.
        At a consultative meeting that I attended last year--I
    think it was last year--Novartis was trying to introduce
    Coartem into Africa. They said we have enough of the drug--in
    fact, they gave us these things, ballpoint pens and a little
    thing as they sell it. It is a beautiful packaging for the
    whole therapy. They said, yes, we sell it for $50, but we will
    give it to Africa for our manufacturing costs, which was 90
    cents which, to a naive person like myself, was a rather
    startling insight into the pharmaceutical industry. Where that
    is going I am not sure.
        In June of this year, I had the privilege and delight to be
    faculty at American Fogarty-sponsored, along with the Gates
    Foundation, workshop in Tanzania on malaria pregnancy. We had
    21 young Africans, a third women, Ph.D.s, physicians, terrific
    kids, who gave great hope for Africa, along with one of the
    great African men himself, Dr. Mutabingwa, as faculty. They
    have found and declared that Coartem is the only thing that
    works. We had been trying to peddle artemisinin plus
    amodiaquine, which was sort of a chloroquine. It has not
    worked. They are going completely to Coartem now. West Africans
    are a little more uncertain about this, but they are coming
    around to it as well.
        The question is: Can we get Coartem to the Africans? Can we
    get Coartem and we diminish the malaria problem in Southeast
    Asia, but it is growing and it is terrible. Areas on the
    Burma--thank you, Ms. French, for telling me it is still Burma
    because I never know how to spell Myanmar--on the Burmese-Thai
    border. In Cambodia it is a tremendous problem. They have had
    outbreaks, pitiful outbreaks even in India again. Asia is
    feeling a real brunt again of malaria. We do not know what is
    happening in the fertile crescent called Iraq, but that used to
    be a terribly malarious area.
        Whether USAID directly can buy a drug that is not approved
    by FDA I do not know. Whether other arrangements--Novartis have
    no desire whatsoever to license this in the United States, but
    it is approved by the European Union, their equivalent of FDA.
        So, for the moment, with falciparum malaria, I think we
    have to go with Coartem. At $1, people object. They say it is
    too expensive. It is inconceivable to me that we would allow a
    child to die for what would cost us a bottle of aspirin at a
    discount store.
        There are other drugs, malarone, mefloquine, which is
    losing its effectiveness, but we do have backup drugs.
        Nobody has to die. I put to you, I think we have the money.
    Everybody decries that there is not enough funds. You put it
    all together and there is enough funding to save every child if
    we can get the drugs to them.
        Let me depart from that a bit and let me speak to DDT. The
    passions are running very, very high once again and always
    excited since St. Rachel wrote her book. It has produced some
    of the most violent discourse I have ever heard. I will tell
    you a story about Alan Ginsburg, which is in the book, going
    down University King Street when he had a very drunken evening
    with us actually saying, I am the bald eagle, when I was trying
    to describe the effect of DDT on him.
        But it is coming back. We have just had a very productive
    meeting last month, Don? July. Time passes. From the National
    Academy of Sciences on DDT, which they now tell me that there
    is not going to be any report forthcoming because NAS is
    beginning to feel the heat.
        I have always been a great advocate of DDT. It is a unique
    drug. It is the best thing since sliced bread. It is terrific.
    There is nothing like it. My concern is that in our fervor to
    reintroduce it, we may overstate the case.
        Don, who is a card-carrying entomologist, knows more than I
    do about it. But I was taught that there are about 50 or 60
    anopheline vectors of malaria and each one of them has
    characteristics that are genetically ingrained and they carry
    their genetic behavior out like a 2-year-old kid. Some of them
    will fly indoors, some will bite indoors, some will bite
    outdoors. They will have different feeding preferences.
        In the fifties and sixties, when they were formulating the
    great global eradication of malaria, which we put $800 million
    into in 1960 dollars, which was neither global nor eradicating,
    we had great intelligence at that point. We knew where to use
    DDT, how to spray it, and where to spray it. And DDT, as we
    have seen, particularly used with Coartem--Coartem I might
    mention also kills the stage of the malaria parasite which is
    transmitted through the mosquitoes. So there is a synergistic
    effect, and that is why it was so effective. And it is a unique
    drug.
        But what we are lacking today--again, if I might say sort
    of a rye joke of age, but the only thing the global eradication
    scheme eradicated was the malariologists. The malaria did fine.
    And I do not think we have the intelligence today to be able to
    pinpoint exactly where and how we must use DDT. I think somehow
    we must gain this even if it means--sorry--taking the money
    from vaccine researchers.
        In this last month or so or 2 months, I have been surprised
    and rather amazed by the, again, various strong feelings on the
    USAID program. Again, I suggested in my report that what I
    think is needed for the general intelligence of where we are
    going to go and what we are going to do, is an independent body
    of people, completely independent, to try to sort out what they
    are doing, how they are doing, and what the malaria situation
    is today. Some of those people are still around. We could still
    do it and they are still independent.
        [The prepared statement of Dr. Desowitz follows:]

    Prepared Statement of Robert Desowitz, PhD., D.Sc., Emeritus Professor
     of Tropical Medicine and Medical Microbiology, University of Hawaii;
    Adjunct Professor of Epidemiology, University of North Carolina, Chapel
                                    Hill, NC

        The manner in which an industrialized nation comes to the
    assistance of the tropical third world's health problems is a faithful
    representation of its economic and diplomatic policies. It is also a
    reflection of its moral and ethical values. In turn, malaria has
    traditionally been the ``epidemiological metaphor'' to analyze and
    assess donor health programs and strategies. But malaria, especially in
    its most lethal guise caused by Plasmodium falciparum is more than a
    metaphor. It is estimated to kill between 2 and 3 million each year;
    young children and pregnant women being its chief victims. It is a
    major cause in hyperendemic regions of spontaneous abortion and low
    birth weight babies. Billions of tropical and subtropical peoples are
    at risk, hundreds of millions are infected. Even in its non-lethal
    form, caused by Plasmodium vivax, it is responsible for untold sickness
    with the debilities of anemia and recurrent fevers. Populations
    burdened with malaria suffer from the lethargy and cognitive defects
    that inhibit economic, technological and cultural progress.
        Our country has had a long, and continuing interest in malaria.
    First, because of our epidemiologic history in which from about 1542 to
    1942 we have been a ``tropical'' country with entrenched ``tropical
    diseases.'' Malaria, which in my 1995 Gorgas Memorial Lecture at the
    National Institutes of Health I characterized as being ``as American as
    the heart attack,'' was entrenched in a vast zone between Florida and
    New York. Second, malaria has been a major factor in the prosecution of
    our tropical wars with, for example, as many troops in Vietnam being
    disabled from combat by malaria as by the wounds of war. The military
    has responded since the 1940s through their medical research
    establishments at home and abroad which continue to be highly
    productive. The Army, at Walter Reed Army Institute of Research with
    its satellite laboratories in endemic sites such as Thailand, Kenya,
    and Malaysia. The Navy at its Medical Research Center in Bethesda and
    satellite units in Egypt and Indonesia. I would particularly note the
    military's contributions to medical entomology and discoveries of new
    antimalarial therapies.
        In the civilian research arena the National Institutes of Health's
    Malaria and Parasitic Diseases Laboratories are internationally
    renowned for their basic research on the malaria parasites. There has
    also been a long and large body of federally funded research coming
    from universities and institutions. The Center for Diseases Control
    have continuing activities in malaria, their great strength being
    epidemiological and operational studies in endemic settings. There have
    also been American organizations to promote the public understanding of
    malaria and facilitate interchange of ideas and knowledge between
    malaria researchers throughout the world. The Malaria Foundation
    International, based in Atlanta with its founder Dr. Mary Galinski of
    Emory University at the helm is the most notable organization and has
    the great potential ability to be a non-biased, non-government
    instrument to organize working parties for strategy sessions. More
    recently the Bill Gates Foundation is funding malaria projects with a
    generosity reminiscent of the Rockefeller Sanitary Commission and
    Foundation of the early 20th century.
        Our government has also had a long history of contributing to
    international malaria endeavors. There is the $800 million, in 1960-
    1970 dollars, we gave to the World Health Organization for their Global
    Eradication of Malaria program--that was neither global nor
    eradicating. The international malaria activities of our own Agency for
    International Development is now, quite properly, under scrutiny by
    this and other congressional committees. It is estimated that the USAID
    annual budget for malaria is $85 million. In addition, since 1972 when
    USAID embarked on their malaria vaccine project I estimate a further
    $250 million has been spent. The project has produced 5 convictions for
    criminal felonies but no vaccine.
        It is the inherent nature of the scientific establishment to
    complain that there is never enough money to make the progress they
    envision to bestow the benefits of research on suffering humanity.
    Malariologists, basic ``molecular'' laboratory-based researchers and
    applied ``field hands'' alike are given to much hand wringing and in
    supplicating for more funding invariably citing the 2-3 million annual
    malaria death rate. From my now comfortable position of retirement--
    free at last from grant writing, I would offer the, no doubt
    challengeable, opinion that the total monies, from American and
    international sources are adequate to bring the malaria carnage to an
    end. That malaria is an eminently treatable disease and no child, born
    and unborn, no pregnant woman, no non-immune adult transmigrant need
    suffer or die of malaria.
        1. Prevention, let alone eradication, is problematic. There are the
    means to reduce transmission, notably DDT and insecticide-treated
    bednets which I will speak to later. Priority should be to furnish and
    deploy appropriate, effective antimalarial chemotherapy in the endemic
    areas of South/SE Asia (as well as in Africa and other regions such as
    Melanesia).
        The cheap, former sheet-anchor of antimalarial therapy and
    prophylaxis, chloroquine, is now virtually useless, because of parasite
    multi-drug-resistant strains of Plasmodium falciparum and to a growing
    extent against Plasmodium vivax. Furnishing of chloroquine by donor
    agencies is useless--and dangerous. Childhood mortality can rise as
    much as eleven-fold when it is not replaced. Until recently the Global
    Fund on the advice of the WHO representatives in Africa (and
    elsewhere?) were still buying chloroquine to distribute to the health
    services of sub-Saharan nations. The overall and nation-specific
    antimalarial drug policy(s), if any, of USAID must be scrutinized by
    unaffiliated experts as expeditiously as possible.
        The antimalarial of choice is the artemisinin combined therapeutic
    (ACT) Coartem (artemisinin+lumefantrine) which rapidly resolves
    parasitemia and fever in severe, multi-drug-resistant falciparum
    malaria. It also has the unique property of acting against the
    gametocytes (the stages responsible for transmission through the
    Anopheles mosquitoes) and thus has a useful transmission-lowering
    action, especially when used in conjunction with DDT spraying. Most
    sub-Saharan African nations have now designated Coartem as the
    antimalarial of national policy and its purchase is being funded by the
    Global Fund and other donor agencies. Coartem is also being used, to an
    increasing degree, in SE Asia, especially in the hyperendemic areas of
    the Thai-Myanmar border, Cambodia, Vietnam and Laos. It is essential
    that USAID adhere to and support these national policies for Coartem's
    use in the treatment of falciparum malaria.\1\ Recent work by Dr.
    Francois Nosten and his colleagues on treating pregnant women in the
    unstable situation on the Thai-Burma border indicates that Coartem is
    safe when used to treat malaria of pregnancy. Coartem is relatively
    expensive but the day of the 10 cents chloroquine treatment is over--
    gone! finished!--and I believe no American would deny a child to his or
    her life for what would be the cost a bottle of aspirin.
    ---------------------------------------------------------------------------
        \1\ Coartem is the only ACT formulation that is produced
    commercially. It is an approved drug in Europe but Novartis has no
    intention of seeking FDA approval in the United States (can USAID
    directly or indirectly purchase a FDA unapproved drug for overseas
    distribution?). The Coartem treatment pack of 24 tablets sells for $30
    to $50 in Europe; however at the 2003 consultative meeting, which I
    attended, called by Novartis, the company declared that as a
    responsible global industrial citizen they would sell it to Africa at
    their manufacturing cost--$1.
    ---------------------------------------------------------------------------
        2. DDT has once again returned to become once again a contentious
    issue as an anti-malarial strategy. A product of World War II research
    (in Switzerland) it remains the unique insecticide by virtue of its
    long residual (up to 6 months) activity, its safety for humans, and its
    dirt-cheapness.
        There is now a coterie of American scientists and science
    journalists who are vigorously advocating--demanding--that DDT be
    returned to the antimalarial armamentarium. Indeed, countries such as
    Ethiopia and South Africa have effectively deployed DDT to combat
    recent malaria epidemics. Several months ago the National Academy of
    Sciences/Institute of Medicine convened a meeting to reconsider the
    introduction of DDT. A report of the meeting has not been forthcoming
    and may never be forthcoming as the NAS feels the heat from the
    ``Silent Springers.'' At that meeting I voiced my belief that DDT is
    incomparably useful--where it is useful. And I voiced my concern that
    the new combative passion for DDT may unrealistically overstate the
    case. An axiom of malaria control is that each of the 50, or so,
    Anopheles species that are malaria vectors has genetically determined
    characteristics (biting preferences, breeding-water preferences, post-
    feeding behaviors, insecticide resistence) that make it a target or
    non-target for attack by DDT. A wry ``in'' joke amongst the surviving
    ``field hands'' malariologists is that the only thing the WHO global
    malaria eradication program eradicated was the malariologists. A real
    problem, as I see it, is that we do not have the contemporary
    epidemiological/entomological intelligence from this absent/diminished
    expertise to formulate region-specific logical strategies for malaria
    control.
        3. Insecticide treated nets (ITNs) are a favorite antimalarial
    strategy of donors. They are easy to buy, easy to distribute (for
    free). Pilot studies have resulted in a 30 percent reduction in
    malaria-caused mortality. Other pilot studies have shown little or no
    effect and a few studies, mortality has actually risen. Going against
    convention I would give ITNs lower priority for funding if it competes
    with chemotherapeutic needs.
        4. Again, contrary to fashionable molecular frontier malariology I
    offer my opinion that the much heralded malaria vaccine is a goal, an
    illusion, that has not been realized and may never be realized in
    combating the disease at a population level.
        Research on the vaccine has been pursued for over 70 years with
    increasing intensification of the effort during the past 30 years.
    Hundreds of millions of dollars, the energies and resources of some of
    our best scientific minds have been, and are, devoted to vaccine
    research. It would be appropriate to now reexamine the overall malaria
    vaccine programs and determine whether some of those resources,
    intellectual and financial, should be redirected to applied
    malariology.
        Some recommendations for the committee's consideration:
        1. We urgently need an independent American panel of experienced
    malaria experts who can speak with authority to authority (this
    committee?).
        2. The panel should have a relatively long term working life,
    probably over several years and be funded for their various
    investigatory and administrative needs. There was such an assemblage in
    the early 1970s, the Effect of Herbicides in Vietnam Committee (in
    which I headed the epidemiological investigations) under the
    administration of the National Academies of Sciences and funded by
    Congress that worked very well. The malaria panel could similarly be
    organized by, and work under NAS, possibly in collaboration with the
    Malaria Foundation.
        3. The panel should critically examine American malaria programs
    and American programs that interface with international programs such
    as the WHO Roll Back Malaria. This is especially true in respect of
    USAID's malaria, funding, policies and activities. The panel would
    therefore need authority to speak with USAID personnel within the
    United States and at their overseas postings, and have access to their
    records (much in the manner that the herbicide committee had in respect
    to military personnel and their spraying records).
        4. The current lack of good malaria-entomological intelligence
    should be addressed by the panel and have the funding to act on this.
    The appropriate experts of the panel (and the experts they would need
    to co-opt) should be able to obtain country-by-country inventory on
    vectors, their behaviors, and suitability for attack by DDT as well as
    the suitability of ITN distribution.
        5. USAID should carefully consider, if not be obliged to follow,
    the expert panel's finding and decisions--especially in respect of
    chemotherapeutic and DDT deployments. There should be a reevaluation of
    United States obligations and interactions with international bodies,
    notably the WHO, on the basis of the panel's findings.
        6. The guiding principle of America's malaria activities should be
    to save lives as expeditiously as possible--to drug malaria into
    submission, to end the carnage of the young and pregnant in the malaria
    regions.

        Senator Brownback. Dr. Desowitz, let me make sure I
    understand this point. You are talking about, I guess, a global
    malaria survey. Am I understanding you correctly?
        Dr. Desowitz. Yes.
        Senator Brownback. Of both cases and vectors.
        Dr. Desowitz. Cases and vectors. We must know where the
    cases are, what they are responding to, what the vectors are,
    and as we knew in the fifties, what their behavior is. Are they
    still DDT-resistant? It may be foolish to spray in some areas.
    I do not know. I do not think anybody else does now. We did 50
    years ago, but we do not now.
        Senator Brownback. Why did we know it 50 years ago and we
    do not know it now?
        Dr. Desowitz. We went at this like gangbusters, sir. In
    1955 when they were beginning the global eradication scheme,
    there were extremely well-trained entomologists and
    malariologists. The whole idea, then, was to carefully evaluate
    all the vectors and to carefully evaluate the epidemiology.
    They did not always act on that knowledge because it became
    very politicized, but it was there. If we had that knowledge
    today, I think we would be in a much better position and we
    would not have to be arguing with each other as well.
        Senator Brownback. Dr. Roberts, what do you think of the
    survey? Do you believe we need that today?
        Dr. Roberts. I do believe we need more medical intelligence
    on a variety of issues in this regard. I think, for example, we
    do not have a really good handle on how bednets, for example,
    actually work and how the different insecticides in these
    bednets actually work. But if we had a good handle on that and
    we had good intelligence on vectors and vector behaviors and
    vector susceptibilities to insecticides in various regions, it
    would certainly be beneficial. However, I do believe we have
    the tools.
        I would also like to emphasize that we are not really
    talking about going back to the silver bullet days of just DDT.
    The struggle is not that. The struggle is to be able to use it
    at all. I think if we could use all of the tools that we have
    available today, they will work in one configuration or another
    in practically any place in the world. That is just my opinion.
        Senator Brownback. Dr. Desowitz, you made a very bold
    statement that there is no child, no woman, no person in this
    world that should have died of malaria over the past--did you
    say 50 years?
        Dr. Desowitz. Yes.
        Senator Brownback. That must make you terribly frustrated
    to see these numbers go up then. I mean, if you are saying that
    50 years ago nobody should have died--we are in 2004 and you
    still have a million annual deaths from malaria.
        Dr. Desowitz. Yes. The simple fact is that each and every
    case of malaria, if you got to it in time or you had proper
    medical administration, is and was treatable. If you did not
    get the drugs, if you faked the drugs, if you sold the drugs,
    if you purloined the drugs, or if you did not have the
    administrative infrastructure to get the drugs to the people,
    that is another thing again. But the drugs were there. Malaria
    was always treatable.
        Senator Brownback. Dr. Roberts, I have received reports
    from individuals, not just on DDT, saying that the U.S.
    Government is pushing some ineffective drugs. Not that they are
    counterfeit or poorly made drugs, but they are just ineffective
    drug regimes that we are supporting. Have you heard that? Is
    there any accuracy to these reports?
        Dr. Roberts. I have heard that. I think there is some
    documentation for that. I believe there was an article
    published in the Lancet not too long ago that would document
    that that indeed is occurring. But to be honest with you, sir,
    I am not an expert in the area of drugs for malaria control.
        Senator Brownback. Dr. Desowitz, have you heard this
    charge?
        Dr. Desowitz. I have correspondence from many parts of the
    world on this. And I do not know. I do not know whether it is
    true or not true.
        Senator Brownback. Are there ineffective drug regimes out
    there that are being pushed by governmental entities?
        Dr. Desowitz. Up until a year ago, they were still pushing
    chloroquine. It was a kind of a chloroquine addiction. They
    were killing people with this. Who was buying it? Certainly WHO
    was pushing it. The Fansidar kind of combination was being used
    and it again was useless in many places. But the Global Fund,
    as I understand it, was buying it.
        Now, I think, they have seen the justice in it and they are
    going to the artemisinin combinations. Whether they are going
    to the only effective one I do not know, and I do not know
    whether Novartis will be selling it to Asian governments with
    the same concessionary price. I do not know.
        Senator Brownback. Dr. Peterson, you have been very kind to
    stay through this, and I appreciate that. May I invite you back
    up to the table? Is there any response you would care to give
    to these two expert witnesses? I would like to give you that
    chance so that we have your response to some of the input from
    these experts, as we try to formulate the right answers and the
    sort of policy issues to put forward.
        Dr. Peterson. Thank you very much, Senator. I appreciate
    the chance to respond.
        First, let me say, I think they are both correct that
    during the eradication effort of the fifties and sixties, the
    thing that died was the malaria expertise. We do not have the
    entomologists and the malariologists that we used to have when
    there was such a huge push, when it was really the single, big
    public health endeavor that was happening at that time.
        We have been tracking the drug resistance in doing the
    surveillance for where drugs are working and where they are not
    working. That is a lot of what you will see, when we do the
    breakdown, that we have been spending our money to be able to
    track how fast it is moving, where, and which are the priority
    countries to try and get the artemisinin drugs into.
        We have good entomologists and good malaria folks at CDC,
    but there are few. I have worked in that branch at CDC, but
    there is not a lot there. I did a little consultation, and my
    understanding is that we probably do not have the world mapped
    out to the extent that we did in the fifties or sixties as far
    as the mosquito vectors, which ones are still transmitting
    malaria of all of the different kinds, which ones are still
    resistant to DDT, and which ones are not resistant. So there
    are some holes that could be fixed and some expertise that we
    need to have.
        On the drugs, we are moving to the combination therapy, and
    together with the surveillance work, we have been pushing very
    hard for moving countries. We have actively helped specific
    countries, as they have shown that they have got significant
    resistance, to be some of the first ones to move to the
    combination therapy.
        I am not sure if Coartem, the Novartis product, is the only
    effective one. That is probably something we need to look at.
    We are sure that we need to be working and bringing countries
    to combination therapies and that one of the combinations
    should probably be the artemisinin.
        It is wonderful that Novartis is willing to provide for
    Africa, but it always better if you have multiple providers.
    Right now, China is the only place that is growing the
    artemisinin, and Novartis is really the sole provider of the
    Coartem.
        What we would like to do is to broaden that. I do not know
    if it has been tried in Afghanistan. I have seen and been in
    the poppy fields myself, and we would love to see them growing
    something different, I promise.
        We have been working in Tanzania and in Ethiopia so that
    Africa can begin to grow the drug that is needed for its own
    malaria. That would bring income to Africa and then they would
    have the solution to their malaria problem in their own
    countries. So that is part of what we have been trying to move
    forward so that there will be an adequate supply of the drug as
    we expand the capability of responding with the combination
    therapies.
        Senator Brownback. Dr. Peterson, what about Dr. Roberts'
    comment about the Vietnamese study on bednets? When you were
    presenting--or was it you or Dr. Desowitz--the 5-year study
    that showed that at the end of the 5 years you did not have any
    significant difference in malaria infections. In my experience
    I have run a little agency that supervised insecticides in the
    State of Kansas. I had entomologists working in the agency.
    Just the idea that you are going to be surrounded by mosquitoes
    and if you stay under the bednets, you will be all right, and
    if you get out you are not, seems like a really crazy strategy
    to me. What if, in the middle of the night, you have to do
    something. You are not going to take the bednet with you and in
    that system you would subject yourself to exposure to the
    mosquitoes. This does not seem to me that this system works
    over a period of time. Yet, it is where we are putting, it
    appears, most of our effort.
        Dr. Peterson. We are putting a fair amount of effort there.
    We do have studies that show that they do work. In fact, with
    the malaria bednets, you do not even have to get as high a
    community coverage as you do for indoor residual spraying. If
    you do community spraying with the indoor residual spraying, in
    order to get collateral benefit, you have to cover 80 percent
    of the homes in that community. With bednets, if you have them
    in a community--and we have got studies that have shown this--
    you not only protect the person who is under the bednet, you
    begin to protect others in the household who are----
        Senator Brownback. How?
        Dr. Peterson. Because it does kill the mosquitoes that land
    on the net. It is some of the same kind of things that he
    talked about for indoor residual spraying, but you have to get
    a higher coverage in the community with the indoor residual
    spraying.
        The doctor talked about the----
        Senator Brownback. Dr. Roberts, respond to that, would you
    please?
        Dr. Roberts. Actually, I do not agree with that assessment
    at all. It really comes down to some very basic relationships.
    If a house is sprayed, the residents of that house are
    protected. If an individual is inside of a bednet, that
    individual inside the bednet is protected. For the bednets, we
    use pyrethroids. For indoor residual spraying, we have in the
    past, at least, used DDT. DDT is the most potent spatial
    repellent we have yet tested.
        The pyrethroids exert no spatial repellent action. They are
    powerful contact irritants and they are potent toxins, but they
    exert no spatial repellency action at all. And that separates
    them from DDT. If you sprayed a house wall with the pyrethroid,
    the mosquitoes will enter. We know that. We have tested it in
    the field. We have tested it in the laboratory. When the
    mosquitoes enter the house, they will bite. The pyrethroid is a
    powerful locomotor stimulant, and so in some cases, it could
    even increase the biting because they are agitated. They are
    highly agitated. With DDT, they will not enter the house.
        So there are major, major differences between modes of
    action of these chemicals. And, of course, as you commented on,
    there are differences in the way they are being used.
        Senator Brownback. Plus, it just seemed to me that instead
    of having individual protection, you try to expand your sphere
    so that people within the sphere are protected--that seems to
    make a lot of sense to me.
        Dr. Peterson. I agree it does make sense, and in fact, that
    is part of what we have seen with the bednets. They are a
    protection also for people who are not covered by the bednets.
    We can get the studies for you.

        [The information requested was submitted and has been made
    part of the committee's permanent record.]

        In outbreak situations, there have been a number of times
    when we have provided both strategies in a household, both the
    spraying of the walls and the bednets around the individual
    person, and that combination is very effective.
        Senator Brownback. And that is great. Let us keep going
    that way.
        Dr. Peterson. I think that is my major point, that we have
    two modalities that provide protection. We need to try and use
    both.
        Senator Brownback. That is my major point. I see you
    funding one, but not the other.
        Dr. Peterson. We are both providing bednets and trying to
    build the capacity of the local systems themselves to produce
    and to distribute the bednets.
        Senator Brownback. OK, not spraying or using DDT.
        Dr. Peterson. We are equivalently encouraging the systems
    to provide the DDT as well.
        Senator Brownback. I do not understand the hesitancy to use
    DDT other than the really strong philosophy and difficulty you
    might encounter from some people on the use of DDT. I
    understand that, I understand that completely. But I do not
    understand why there would be any hesitancy to using or
    supplying DDT other than, I understand, a strong pushback from
    the environmental community or others that do not like DDT. I
    do not like it at all. I have seen that war and I understand
    that philosophical position and I respect it, but as somebody
    who is trying to pay for treatments, I do not understand why
    you would not be using DDT.
        Dr. Peterson. We have no opposition, and in fact, through
    the Global Fund and other moneys, we are supporting it and we
    are supporting programs that have incorporated it.
        I think, again, there are rural areas where it is going to
    be harder to reach, and the doctor talked about the compliance,
    the staying under the bednet. We have equivalent situations
    with people willing to have their homes sprayed with
    insecticides, but not liking the color that it changes it and
    repainting it. We have compliance issues in all of these areas,
    and therefore, we need to have both available in the places
    where it is most appropriate.
        Senator Brownback. I agree with that.
        Thank you. Thank you, gentlemen, for being here, for your
    years of work and expertise and effort. I look forward to the
    day when that number starts going way down. Maybe we do not get
    to zero soon, but we really start to drive those numbers down
    hard and fast. I do think it is within our capacity to do it.
    Thank you all for being here.
        The hearing is adjourned.
        [Whereupon, at 4:05 p.m., the subcommittee was adjourned.]