[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/
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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

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                                                                   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.
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    \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.
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    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.]
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