<DOC>
[109 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:26748.wais]
S. Hrg. 109-614
BILATERAL MALARIA ASSISTANCE: PROGRESS AND PROGNOSIS
=======================================================================
HEARING
before the
FEDERAL FINANCIAL MANAGEMENT, GOVERNMENT
INFORMATION, AND INTERNATIONAL
SECURITY SUBCOMMITTEE
of the
COMMITTEE ON
HOMELAND SECURITY AND
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
JANUARY 19, 2006
__________
Printed for the use of the Committee on Homeland Security
and Governmental Affairs
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COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
SUSAN M. COLLINS, Maine, Chairman
TED STEVENS, Alaska JOSEPH I. LIEBERMAN, Connecticut
GEORGE V. VOINOVICH, Ohio CARL LEVIN, Michigan
NORM COLEMAN, Minnesota DANIEL K. AKAKA, Hawaii
TOM COBURN, Oklahoma THOMAS R. CARPER, Delaware
LINCOLN D. CHAFEE, Rhode Island MARK DAYTON, Minnesota
ROBERT F. BENNETT, Utah FRANK LAUTENBERG, New Jersey
PETE V. DOMENICI, New Mexico MARK PRYOR, Arkansas
JOHN W. WARNER, Virginia
Michael D. Bopp, Staff Director and Chief Counsel
Joyce A. Rechtschaffen, Minority Staff Director and Chief Counsel
Trina Driessnack Tyrer, Chief Clerk
FEDERAL FINANCIAL MANAGEMENT, GOVERNMENT INFORMATION, AND INTERNATIONAL
SECURITY SUBCOMMITTEE
TOM COBURN, Oklahoma, Chairman
TED STEVENS, Alaska THOMAS CARPER, Delaware
GEORGE V. VOINOVICH, Ohio CARL LEVIN, Michigan
LINCOLN D. CHAFEE, Rhode Island DANIEL K. AKAKA, Hawaii
ROBERT F. BENNETT, Utah MARK DAYTON, Minnesota
PETE V. DOMENICI, New Mexico FRANK LAUTENBERG, New Jersey
JOHN W. WARNER, Virginia
Katy French, Staff Director
Sheila Murphy, Minority Staff Director
John Kilvington, Minority Deputy Staff Director
Liz Scranton, Chief Clerk
C O N T E N T S
------
Opening statements:
Page
Senator Coburn............................................... 1
Senator Carper............................................... 18
WITNESSES
Thursday, January 19, 2006
Michael Miller, Deputy Assistant Administrator for Global Health,
U.S. Agency for International Development...................... 7
Simon Kunene, Malaria Program Manager, Swaziland Ministry of
Health......................................................... 24
Donald R. Roberts, Ph.D., Professor, Division of Tropical Public
Health, Department of Preventive Medicine and Biometrics,
Uniformed Services University of Health Sciences, Bethesda,
Maryland....................................................... 26
Andy Arata, Vector Control Specialist............................ 27
Alphabetical List of Witnesses
Arata, Andy:
Testimony.................................................... 27
Prepared statement........................................... 63
Kunene, Simon:
Testimony.................................................... 24
Prepared statement........................................... 38
Miller, Michael:
Testimony.................................................... 7
Prepared statement........................................... 35
Roberts, Donald R., Ph.D.:
Testimony.................................................... 26
Prepared statement with an attachment........................ 48
APPENDIX
Two charts submitted by Senator Coburn entitled ``USAID Malaria
Spending for FY04''............................................ 65
Article submitted by Mr. Roberts entitled ``Overcoming Regulation
Based on Innuendo and Litigation''............................. 67
Questions and responses for the Record from:
Mr. Miller................................................... 69
Mr. Roberts.................................................. 79
Roger Bate, Resident Fellow, American Enterprise Institute and
Director, Africa Fighting Malaria, and Richard Tren, Director,
Africa Fighting Malaria, prepared statement.................... 84
BILATERAL MALARIA ASSISTANCE: PROGRESS AND PROGNOSIS
----------
THURSDAY, JANUARY 19, 2006
U.S. Senate,
Subcommittee on Federal Financial Management,
Government Information, and International Security,
of the Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:30 p.m., in
room SD-342, Dirksen Senate Office Building, Hon. Tom Coburn,
Chairman of the Subcommittee, presiding.
Present: Senators Coburn and Carper.
OPENING STATEMENT OF SENATOR COBURN
Senator Coburn. The Subcommittee will come to order.
I would like to thank our witnesses for taking the time to
testify and the tremendous effort that some of them made to get
here, the long distances they traveled.
This is a follow-up hearing to a hearing we had some 6
months ago, and it is important for America to realize that
malaria sickens somewhere around 500 million people a year. It
kills nearly 2 million people every year. Of those, 85 percent
of the victims reside in Sub-Saharan Africa. As we sit here for
the next 2 hours, 240 more children will die from malaria. The
United States will spend $105 million to fight malaria this
year, and the President has a new initiative where he has
committed $1.2 billion over the next 5 years to fight this
dreaded disease. With plans to scale up spending so
dramatically and in such a short period of time, it is all the
more important that we get it right, that our program saves
lives in a measurable way.
After our hearing on this subject last year, U.S. Agency
for International Development (USAID) went through its books
and reported that less than 8 percent of the bilateral malaria
budget went toward life-saving commodities such as $2 drugs
that cure the disease, insecticides to kill the mosquitoes that
carry the disease, and nets to keep the insects off people
while they are sleeping. What is worse is that the majority of
that 8 percent was spent to sell bed nets rather than to give
them to the people who could not afford to buy them.
When we brought some sunshine to the budget on this
project, we discovered that the vast majority of the malaria
money was going to advice-giving programs, administrative
overhead, travel, and conferences. In other words, we spent
most of our money telling people how to use the cheap and
effective tools to fight malaria and very little money actually
providing them those tools and very little money actually
saving lives.
Despite good intentions all around by those dedicated
workers at USAID, our priorities have been out of whack. But
things are changing, and I want to commend President Bush and
those at USAID for recognizing the problem and announcing the
major reforms over the past 6 months to change course. The
President's plan targets a few focus countries at a time for
nationwide coverage with life-saving interventions, including
insecticide spraying in homes and drug procurement. But even in
countries not initially targeted, USAID recently announced an
overhaul of its malaria programming so that by next year 50
percent of its budget in those areas will go towards purchasing
commodities and 25 percent of its budget will be spent on
spraying. This is ground-breaking movement, and I am encouraged
to think how many children and pregnant women might be spared
death from this preventable and curable disease.
I want to congratulate the President for his leadership,
and especially Assistant USAID Administrator Kent Hill and his
deputy, Michael Miller, who is here today, for their courage
and commitment in the face of the grueling task of implementing
reforms at the programmatic level. It is very easy for Members
of Congress to throw stones and criticize. It is quite another
thing to actually turn a program around and change an
international bureaucracy and move it in a different direction.
We are having a follow-up hearing today because the sound
policy and planning that have been achieved so far are only the
beginning. So what I would like to do is get into some of the
details of what we will be looking for over the coming months
to carry out the new initiatives:
Accountability. One of the first principles we aim for here
is transparency. We have been assured that a website would be
launched that tracks all the money and the progress made with
that money toward measurable indicators. So far, the website is
not up and is not running, but I will be interested to hear a
firm date for that launch so that taxpayers and congressional
overseers can perform our job of seeing where the U.S. dollars
are actually carried out in action.
Second, the President's initiative sets an ambitious goal:
85 percent coverage in focus countries of vulnerable
populations with life-saving interventions, as appropriate. And
it is that ``as appropriate'' that provides wiggle room, some
of which is very legitimate. But we do not want to open
loopholes that allow for those who are content with the status
quo to rest on their laurels. So far I haven't seen any of the
technical guidelines or the criteria that govern when, where,
and for whom certain interventions should and should not be
used. It seems that these decisions are being made on an ad hoc
basis for each country, which makes it difficult to compare the
results across countries, to assess the scientific soundness of
those decisions, and also for other donors and other countries
who are looking to us for guidance about how to fight malaria
in other countries and to imitate what we hope may be the most
successful anti-malaria campaign since the world eradication
effort last century.
Let me outline some of the basics we are looking for:
Insecticide spraying in homes virtually everywhere; the use of
the cheapest and most effective insecticide, which almost
always turns out to be DDT. The World Health Organization (WHO)
and others have stigmatized DDT long enough, even as
environmental groups now concede that the chemical should be
used for malaria control. No human or wildlife harm has ever
been demonstrated when DDT is used for spraying of homes. The
unnecessary death toll caused by a bias against DDT needs to
end right here and right now. I will be expecting USAID to
reverse years of damage caused by an anti-DDT message by
enthusiastic and vocal support with dollars and words for
spraying with DDT.
Next, a bed net distribution strategy that can
realistically reach 85 percent coverage for vulnerable
populations. Since almost every household contains a child
under five or a woman of child-bearing age, that means you have
to get at least one, maybe two or three bed nets into most
houses in focus countries. That is going to involve a lot of
free bed net distribution, and not a marketing campaign to sell
nets.
We will want to see artemisinin-based combination
chemotherapy used where there is resistance to older drugs
greater than 10 percent. If we do not know what the resistance
levels are in a given area, we should use artemisinin until we
can establish what those resistant levels are.
USAID can streamline the use of indoor insecticide spraying
through lifting of regulatory barriers. Massive environmental
impact assessments for public health initiatives were never the
intent of Congress in the National Environmental Policy Act. I
suggest that USAID carefully review these laws and regulations.
Rather than trying to justify the onerous regulations as not as
problematic as they seem, I would rather see the Acting
Administrator of USAID exercise his authority to remove the
barriers altogether.
Finally, setting numerical goals for commodity allocations
will further validate this Administration's commitment to
saving the lives of Africans. While a commitment was made for
countries not targeted by the President's initiative, I would
like to see some targets set for the President's focus
countries as well. You see, what we saw and what we do does
echo around the world. We are only one player vitally concerned
with the welfare and health of those on the continent of
Africa. But we are the biggest player when you count both our
bilateral and multilateral contributions to malaria control. If
our message and our money go out in a science-based,
unapologetic, reformist way, the whole world will change with
us.
Given the death toll from this disease, nothing short of
dramatic change by every donor and every host country's malaria
program is necessary. We are losing generations in the
meantime.
You will see on this other photograph a few of the children
who died in one year at one school in Uganda from malaria.
Tremendous potential wasted because we have not been effective
in helping those that are dependent upon us. Every minute we
take to get these programs up and running is precious time lost
for millions of children just like them.
[The prepared statement of Senator Coburn follows:]
[GRAPHIC] [TIFF OMITTED] T6748.001
[GRAPHIC] [TIFF OMITTED] T6748.002
[GRAPHIC] [TIFF OMITTED] T6748.003
Senator Coburn. I know our witnesses today share my
passion, and I am grateful for their time and their hard work
to end the scourge of malaria on the world's children and
families. And I want to thank you for being here.
Michael Miller has been with USAID in his present capacity
since 2004. We welcome him back to the Subcommittee for the
second time. He serves in various interagency capacities for
USAID in the implementation of the President's Emergency Plan
for AIDS Relief, PEPFAR, and is directing the implementation of
the President's Malaria Initiative.
Mr. Miller, you are welcome. Your testimony has been read.
It will be introduced into the record as submitted, and you
will be recognized for 5 minutes. And thank you again,
personally, for being here.
TESTIMONY OF MICHAEL MILLER,\1\ DEPUTY ASSISTANT ADMINISTRATOR
FOR GLOBAL HEALTH, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT
Mr. Miller. Senator, it is my pleasure to be back, and we
really appreciate your support and your interest in this. When
we make big changes like that with any institution, it is never
easy. And having the support of Congress is going to be
essential as we go forward to maintaining those and building on
those successes.
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\1\ The prepared statement of Mr. Miller appears in the Appendix on
page 00.
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Since this Subcommittee's last hearing on the topic, the
President has changed our global malaria strategy fundamentally
in scope, size, and structure. Additionally, USAID has
implemented necessary, complementary changes to its ongoing
malaria programs. These changes, I believe, ensure greater
effectiveness and accountability, provide critically needed
global leadership, and will ultimately save more lives.
The most important development is the President's Malaria
Initiative--or PMI, as we call it--which is a multi-agency
program led by USAID. The PMI will reduce significantly the
number of Africans who die from malaria and will challenge
other donors to make similar commitments. President Bush's
commitment of an additional $1.2 billion over the next 5 years
is unprecedented in the fight against malaria. Accordingly, the
goals of PMI are ambitious: Reduce by 50 percent the number of
deaths from malaria in target countries. The program will
eventually include up to 15 countries and benefit 175 million
Africans.
The speed with which we have begun to implement the PMI is
also unprecedented. In less than 6 months after the President's
announcement, USAID was already in the field implementing
programs that differ considerably in scope and size and focus
from their predecessors. Right now, the PMI is conducting an
indoor residual spraying campaign in southern Angola to protect
over 500,000 people from epidemic malaria outbreaks. We
recently distributed 130,000 long-lasting insecticide-treated
nets in Zanzibar, which we will also follow up with indoor
residual spraying. And in about a week, we will begin the
distribution of 270,000 free long-lasting insecticide-treated
nets in war-ravaged northern Uganda, among many other
activities.
PMI is a very different way of doing business than past
practice. The hallmarks of the PMI are first and foremost
programming based on clearly defined numerical targets for
outcomes. Second is transparency in how the money is being
spent. Third is a robust and effective monitoring and
evaluation plan to make sure that we are, in fact, reaching our
goals. This approach provides assurances that taxpayers' money
is being spent effectively.
PMI's size and structure also provide opportunities to
fight malaria in Africa in ways we could not just imagine a few
years ago. In the past, USAID used the relatively small amount
of funds to implement programs focused on issues such as
policies to adopt artemisinin combination therapies over
failing treatments, among other things. Much of that work is
now done. With the PMI, we have the opportunity to design and
implement many simultaneous, large-scale, comprehensive--
meaning providing commodities as well--country-wide programs
throughout Africa.
But that opportunity also necessitated changes to the
programs currently outside the PMI, as we call it, the non-PMI,
the existing USAID malaria programs. These are the structural
changes we announced in December. One of the most visible
changes is the elimination of programs that were simply too
small to be effective on a scale we require. That was set at
$1.5 million for this year. It will go up to $2.5 million for
next year. Second is a correction of the imbalance between
technical assistance and commodities, which we spoke about at
length. Third is the opportunity to push the dialogue and think
about indoor residual spraying as a frontline tool for fighting
malaria in Africa, and we believe it has been under utilized.
The rapid scale-up of PMI means that next year more
resources and more coverage of people will be inside the
program than outside the program, since there is a very rapid
graduation in. As a consequence, having two parallel but
different programs side by side is as impractical as it is
undesirable. Because PMI will expand rapidly, any real
distinction between the two has to be temporary, and the
programs that now fall outside the PMI have to start making
critical adjustments now, including emphasis on life-saving
commodities, reporting on planned activities and allocations,
and programming more money.
In the case of Indoor Residual House Spraying (IRHS), this
year we will spend approximately $20 million on spraying, and I
would note that is two times the entire amount of the global
malaria programs in 1997 just on spraying alone this year, and
about a 20-fold increase over fiscal year 2004. In at least
three of the eight countries where USAID will support IRHS this
year, DDT will be the primary insecticide. As some countries
move into the matrix of PMI countries--in other words, they
move off the list of outside PMI and into PMI--the specific
numerical targets and the monitoring and evaluation regime will
also apply to them as well. In short, the changes we instituted
to the non-PMI are part and parcel of the creation of a single,
large-scale, target-driven strategy to fight malaria in Africa
and to demonstrate those results.
What we have begun to do with PMI, as we have done with the
President's Emergency Plan for AIDS Relief, PEPFAR, is to judge
and plan our programs based on outcomes, not simply on how much
money we put in at the beginning. The difference is simple but
profound in terms of how we plan and how we go about it. It
demands a level of new programmatic transparency and
documentation that in turn provides confidence in the
effectiveness that allows the President to make the multi-year
commitments and ramp up funding accordingly. Targets keep
agencies, individuals, and entire governments focused. With
accurate data, targets provide unambiguous measures of success
or failure and allow informed judgments about whether the
program is effective, whether it should continue to be funded
or not, or that money should be moved elsewhere. Ultimately,
that not only makes for good management and good governance, it
is much more satisfying for those of us who are charged with
implementing the programs. It also makes them more effective.
In the case of the PMI, that means the opportunity for the
United States to fill a global leadership role in the fight
against malaria and to save millions of lives that might
otherwise have been lost to a preventable and curable disease.
Thank you.
Senator Coburn. Thank you so much for coming. One of the
things you alluded to was the transparency and accountability
of this new program, and we have talked about having a way for
the American public to track that. And this is not just with
USAID. The American people ought to be able to see where all
their money is going all the time, except in national security
issues. And the idea of having that available to the American
public, when do you perceive that will be available?
Mr. Miller. I will make a distinction between the fiscal
year 2004 data and the fiscal year 2005 data, because we have
collected them at different times. The fiscal year 2004 data is
complete. We have put what we call the aggregate or the
composite spread sheet of expenditures up on the website
yesterday or the day before. And then as we actually make the
typed corrections, if you will, to the data sheets that we
corrected by hand as we conferred with the field, did
mathematical corrections and things like that, those will be
posted subsequently. I think the last time I asked the staff
was doing it. There were five up.
So the 2004 data is complete, and it is starting to be
posted. The 2005 data is going to take a little longer simply
because when the fiscal year ended, we sent out the
questionnaire, I believe, on October 31. So the missions
received it presumably that day and were able to start
collecting that data themselves and sending it out to their
grantees for them to return data back to the mission.
That will take a while because of a couple factors: Simply
because they have not closed their books, they are still
spending some 2005 money. They have to rely on the grantees to
send the information back, which, of course, you cannot always
guarantee. Not much happens over Christmas in many of these
countries, including here.
Senator Coburn. Well, the point I am getting to is there is
going to be created a continual expectation that there is going
to be data collection and transparency, where the money is
spent and the results of the money.
Mr. Miller. Absolutely. Our goal is to have by February 10
the complete 2005 data. If it is not accurate, we will not post
it. We will continue to go back and make sure it is accurate.
We do not want to rush it. But 2006 and beyond, it is built
into the system, and that is the benefit that we do not have to
do a retrospective.
Senator Coburn. Under the President's Malaria Initiative,
the goal is 85 percent coverage of vulnerable populations as
appropriate. How would you define ``vulnerable populations''?
Mr. Miller. Children under five, people living with HIV/
AIDS in malarious areas, and pregnant women.
Senator Coburn. OK. And what four interventions are
essential to achieve malaria control?
Mr. Miller. Insecticide-treated nets and indoor residual
spraying as prevention measures at the household level;
treatment, ACTs, and treatment of expectant mothers with
intermittent preventive treatment. That is four.
Senator Coburn. When we go back to the goal of 85 percent
coverage of vulnerable populations as appropriate, can you
define to me what criteria you all are going to use for this
``as appropriate''?
Mr. Miller. There will be some cases where--it is rare, but
in general you can say in most areas in tropical Africa, in the
countries that we are focusing on this year and next year,
everybody within those categories will be vulnerable; almost
100 percent in Angola I think you can say. There will be parts
of--well, almost 100 percent, but there are parts of Angola, in
the highlands, where it may not be. There are parts of--people
who live in the cities perhaps are not vulnerable. But, in
general, I think you can say almost anybody who fits in those
three categories of HIV/AIDS positive, children under five, or
pregnant women is more than likely going to be in the
vulnerable population.
Senator Coburn. The ultimate goal is to fund adequately all
four interventions.
Mr. Miller. Right.
Senator Coburn. How are you going to make the decisions for
priority, for which comes first?
Mr. Miller. Well, the idea is to do all simultaneously. We
want those levels of coverage on all of them. The one
distinction I will make is between nets and spraying. Whereas,
at the home level, if you can achieve coverage of one of those
two at 85 percent, we believe we will be meeting our targets.
Now, there are cases where, in fact, in Zanzibar, we will
do what we call the suspenders-and-belt approach, which is
spraying and nets made available. And we will see what the
effect of that is. What we do know is in the case of if you
have proper and effective use of a net or the proper and
effective use of IRHS, you can reduce the incidence of malaria
for the protected person by 90 percent.
Senator Coburn. But the difference is you can do IRHS once
a year and have a variable use of net of not use of net, where
somebody takes the net and goes fishing with it instead of
using the net for prevention. So I guess I presume by your
answer you all have scientific data to say that nets, if you
get an 85-percent coverage, are just as effective as IRHS?
Mr. Miller. The way I would characterize it is we do know
that nets are effective, we do know that IRHS is effective.
What I don't think we, the world, really have a sense of is
exactly what the distribution should be, how much IRHS versus
how much nets.
Now, there are practical considerations as well, some areas
where it would be conceivable that it simply just becomes cost-
ineffective to do IRHS, which does have a logistical train
along with it. You do have to have acceptance rates and stuff
like that. But you are correct, there are clear advantages in
some cases of IRHS over nets. And what we hope to find out is--
take the issue of IRHS, which we believe has been
underutilized, and start to push the issue to have people
asking the question how much IRHS can we do, where is it cost-
effective to really get the data on this, we have some data,
and we know from places like South Africa, and I am sure in
Swaziland, a place like that, that it can be very cost-
effective. But what we don't know in these countries that are
hyperendemic countries like Uganda, where 95 percent of the
country has transmission almost all year round and they have
not done spraying in decades. Where is it that we can cost-
effectively do spraying before we start running out of money or
where in the case--or if that is the case, where nets would be
more appropriate.
Additionally, we also have net distribution networks up and
running. One of the tragedies, if you think of IRHS, is because
it has been underutilized--and it is not just DDT. I think it
is IRHS across the board. There is very little institutional
capacity in these countries. For the case of Uganda, I had a
very interesting conversation with the National Malaria Control
Program and with the Vice President himself, who is also a
physician like you. They are very inclined to use IRHS. They
are leaning heavily towards DDT. But in this first year, they
have chosen, under the PMI, in fact, to choose one district,
Kabali District, do spraying in one district, and then see
how--get their feet under them, essentially, start moving out
to the other 14 districts that they have targeted, and then
make a decision as to whether they think in that case they can
rotate DDT in instead of synthetic pyrethroid. Their preference
would be to use DDT simply because it is more effective in
their case.
Senator Coburn. It is also markedly less expensive.
Mr. Miller. It is a fourth of the cost, is what they told
me.
Senator Coburn. For the same amount of dollars, you get
four times the amount of coverage. Once you have the
infrastructure there.
Mr. Miller. Right. I don't think the math would work out
exactly, but, yes, you can presumably get much more coverage
because the largest single cost in that program, speaking of
Uganda specifically, if I remember right, it was the
insecticides. So if you cut that by a fourth--now you do have
additional transportation costs. DDT is bulkier, but you also
have cost savings where DDT can have a longer residual effect--
--
Senator Coburn. It is twice as long.
Mr. Miller. Yes, and that is also the case in some other
countries. We found that you could spray once a year with DDT
or potentially----
Senator Coburn. Well, I think that is pretty well known. We
are going to have some testimony today about that, and the fact
is it is significantly less in cost, it lasts twice as long,
and it is more effective. They are not equal in effectiveness.
Mr. Miller. Right. And there are cases where the building
material, if it is a finished wall or a painted wall, you
really have to make a judgment because there are adherence
issues, residual issues, and streaking apparently is a problem
when they wipe it off the wall.
Senator Coburn. Is there still a plan in the new Malaria
Initiative to subsidize nets rather than just giving them out?
Mr. Miller. The principle that USAID has established that
economics should never be a barrier to net ownership, I think,
is a sound principle. It is not the only--that in itself is not
a net plan. It is a good principle, and we will stick to it.
But my personal belief is at the levels of coverage we are
looking at and the fact that so many people in malarious areas,
particularly in rural areas, people who are destitute, who
simply never will be able to afford a net under any
circumstances, or people who possibly could but will have no
exposure to a socially marketed message or very little contact
with a formal marketplace, that those people--we cannot
realistically expect that we can reach the kind of levels we
want to by selling nets alone. And, yes, I think we will have
to--we are prepared to, as the situation warrants, provide free
nets, as we are in Uganda already, in large amounts.
Senator Coburn. Other than infrastructure to do indoor
residual spraying, the infrastructure limitations to be able to
train people to do it, when is IRHS inappropriate in your view?
I am hearing that bed nets equal IRHS, and from what I have
read, I do not read that in the literature.
Mr. Miller. No.
Senator Coburn. I am going to learn some of that today, but
from what I have heard from you--and I have a little bit of
concern--is that we are liable to not use the most effective,
and the variable is if you have a bed net in your home and you
don't use it, you don't have coverage.
Mr. Miller. You don't have coverage, yes.
Senator Coburn. If your home has been sprayed with DDT, you
have coverage for a year.
Mr. Miller. Correct.
Senator Coburn. There is a big difference. You take a
variable out of the equation.
Mr. Miller. Yes, I agree that IRHS has many advantages in
many situations. What we do not know--generally, IRHS has been
underutilized. I think there is a big question mark about how
much we can get--the cost-effectiveness, what kind of coverage
levels--with the money we have. I think that just requires
doing a lot more of it. I think we have commissioned a study
that will look at all the available data on cost-effectiveness,
but I do not have confidence that alone will really give us the
picture. I think we have to put more money against it and see
what the data is, because there are a lot of questions about
how effectively we can use it. And I think we can use it much
more effectively, and that is sort of less of a question. But
in the single home--I should clarify. What I meant is in a
controlled situation, if you are using a net properly in a
controlled situation, if you are in a home that has been
sprayed properly, that individual, that vulnerable individual,
can enjoy certain amounts of coverage. Now, I suspect that
there are situations--and from past experience people say in
urban areas, in peri-urban areas, there are these sort of
diffuse, quasi-urban areas around the big cities in Africa,
that spraying is much more advantageous. And that is what we
are really aiming to find out, is put money behind that and see
what really are the cost-effectiveness numbers that we can take
to the bank and really plan against in future years.
Senator Coburn. In November of this year, the South African
Health Ministers, it was resolved that member states should
support IRHS with insecticides. And, recently, Ugandan
scientists urged their government to support IRHS with DDT. Is
there some outside barrier to indoor residual spraying with
DDT?
Mr. Miller. With DDT? Yes, I think there is. There is a lot
of ignorance about DDT, as I think we have seen. People are
afraid of it, and that is not just here. Again, I will go back
to my Ugandan experience. I had a very fascinating conversation
with Vice President Bukenya, who said they, for example, have
started a net retreatment program in the area around where he
is originally from, and they had very little uptake--uptake
meaning people actually accepting the service for free. And
they found out a rumor had gone around that the retreatment was
with DDT, which, of course, first, is false, we don't treat
nets with DDT; and, second, it is false that it is harmful to
humans in indoor residual spraying.
So there is ignorance we have to fight and----
Senator Coburn. So do you all have a plan to address that
in terms of remove the barriers to IRHS with DDT?
Mr. Miller. Absolutely. Well, the first part of the plan is
simply do more of it. In fact, in the non-PMI programs, when we
dedicated that 25 percent to IRHS, what we were able to do is
go through and essentially cherrypick countries where we knew
they had very robust IRHS plans and national malaria control
plans, which is not true for every country, and where we had a
reasonable number of them that would use DDT.
Now, one of the main ones that does not in that roster of
four--five if you count Madagascar, and I will come back to
that--Kenya does not. And they have the same problem that
Uganda does, which is essentially if I--this is my own
characterization. They feel like they are over the barrel in
terms of exports, particularly to the EU, and they think it is
a real concern, and I think it is, that the standard is very
high that if there is any DDT detected in the cut flower
industry, in the vegetable exports, freshwater fisheries, all
of which are common to those countries and to Tanzania, then
they face potentially a ban to exports to the EU. That would
cripple their economies. In their minds, there would be no
advantage.
In Uganda, DDT is not illegal. But as I mentioned, they are
essentially going to get themselves back into the IRHS program,
understand what they want to do, make sure there is no seepage
out in the agricultural community, make sure the security
around sprays are adequate. In Kenya, they still have a ban. We
have not had any dialogue with them as to whether they would
lift that. I think they are going to have to make that decision
on their own.
But to answer your question, yes, there are. There are many
considerations for them.
Senator Coburn. I am going to turn this over to Senator
Carper, but it is interesting when you look at the signs and
you look at the death rate in Africa and you look at the
effectiveness of DDT, and we are going to hold people hostage
to not do the most effective, the most efficacious treatment
and public health strategy because we are going to threaten
them with poor science because we don't understand the poor
science. And I think there is an obligation on your part to
bear the pressure to change that with the EU. When 500,000 kids
die a year because there is not IRHS and there is not
artemisinin and there is not the medicines made available, and
the IRHS isn't there because somebody is afraid--not on the
basis of scientific but on the basis of emotion--that it is
going to have an impact on somebody, that is hijacking the
world's poorest people in the worst way.
[The prepared statement of Senator Carper follows:]
[GRAPHIC] [TIFF OMITTED] T6748.004
[GRAPHIC] [TIFF OMITTED] T6748.005
[GRAPHIC] [TIFF OMITTED] T6748.006
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. Thank you, Mr. Chairman. Good to be with
you again. And, Mr. Miller, thank you for joining us.
I think you were before us back in May. Is that right?
Mr. Miller. I was.
Senator Carper. I thought so. If you would start with a
little bit of a timeline for me, please, and take it from May
when we had our hearing, and I think the President maybe
offered his initiative in, I want to say, early summer, maybe
June, can you walk me through the timeline from where we were
back in May and sort of chronologically what is different today
and when did that occur.
Mr. Miller. Yes, sir. I believe the hearing was May 12. By
that time, we were already in very early planning stages with
the White House in terms of what kind of program we could
potentially propose to the President in the lead-up to the G-8.
And a lot of the planning around the President's Malaria
Initiative really was from the G-8. As you know, last year at
the Gleneagles Summit, the United Kingdom had as their theme,
if you will, global health. And so one of the global health
initiatives we had was a series of options on what we thought
we could do in malaria. Ultimately, the President chose it
because it could be--it is doable. Malaria is beatable. There
is plenty of room for global leadership on this. And it is
something we can do--with relatively reasonable amounts of
money, we can have a huge impact. And that is why he chose it.
He chose that leading up to the G-8, and by June 30, we had
a completed proposal that he had approved, and he announced on
June 30. We were up and running pretty fast. Certainly by
December we had the spraying program started in Angola. We had
net distribution started in Tanzania, and we will start the
programs in--the jump-starts in Uganda as well.
Also by December, we had our country teams make two trips
to the region. The first was to make a needs assessment, and
that is an assessment where a team, some of the malariologists
that are with me here, went to Tanzania, Angola, and Uganda,
and along with other donors, with the World Health
Organization, and with the governments of those countries, the
National Malaria Control Programs, made an assessment of who is
doing what where and who is not doing what where and where we
can start planning to put our resources against that. That was
in August. The second would be a series of planning trips, both
by country staff that is already there and our expertise here
going out as needed, to pull together a country proposal,
essentially. This is modeled, if you are familiar with PEPFAR
COPs, the country plans that they submit every year, which show
what they are going to do, with who, and where. We had a small
version of that submitted to us. We had an interagency team
that included Secretary Leavitt's office, the Centers for
Disease Control, DOD, State Department, Office of Management
and Budget, the White House, the National Security Council, and
us.
We reviewed those and approved them in large part on
December 20. So just in that 6-month period or so, less than 6
months, we actually had approved programs, money behind them,
and activities going on in the field.
Senator Carper. That is pretty fast.
Mr. Miller. Very fast, yes. And I should add----
Senator Carper. Do you think it was largely instigated by
our hearing, probably? [Laughter.]
That is probably giving us more credit than we deserve.
Mr. Miller. It certainly did not hurt.
Senator Coburn. Let me answer that. There are a lot of
people that are interested in this. Senator Brownback has been
working in this area for a long time. There are people in USAID
that want to see it more--the people that work at USAID want to
see success. And so highlighting it helps raise the pressure on
it, but the leadership, both in USAID and at the President's
level, is responsible for this change, not us. And you did not
hear my opening statement, but I said that.
Mr. Miller. But we do certainly appreciate your interest
and support on that.
I should also add that also in December Administrator
Natsios signed a fairly comprehensive and fundamental
restructuring of our programs, malaria programs within USAID
that currently fall outside the President's Malaria Initiative
but are in the process of graduating in. So that was all within
a 6-month period. We started the Presidential initiative, got
it up and running, and independently made pretty fundamental
reforms internally.
I do have to give a tip of the hat to PEPFAR. The fact that
we in the U.S. Government, we had exceptionally good leadership
within PEPFAR from Ambassador Tobias, so we are very pleased to
hear the news about him today--that is right, if the Senate
confirms him, of course. And we also had the benefit of seeing
where the barriers were, where things were easy, what kind of
numbers we had to collect, what kind of data we needed in the
end to prove that we were meeting our goals. And then the most
basic point is that you have a program that is based on
targets. You set a target that is realistic, you say how you
are going to get there, and then you start programming against
that with a program that can prove it is getting there. And
that is the real innovation with PMI that PEPFAR really led the
way on, and we have benefited tremendously. The people in the
countries that have already gone through the process of making
a country plan and that kind of planning and that kind of
reporting was much easier for them and much easier for us. We
have already been through that. So very much benefited from
that.
Senator Carper. Just take a very short while on this one,
and I know you spoke of this in your statement, but how are we
doing? It has been 6 months since the President unveiled the
initiative.
Mr. Miller. I think we are doing great. I am very
satisfied----
Senator Carper. How are we doing and how do you measure
success?
Mr. Miller. We measure success in lives saved at the end of
the day. The end of the day is actually at the end of 5 years,
but we do have within that 5-year period ways to measure our
progress. And it is very important.
At the end of year two, or halfway in--first we establish
baselines, what the coverage is in a country, what gaps we need
to fill, what the mortality is from malaria, particularly in
children under five. And halfway in, about the end of year two,
we make an assessment of what our coverage rates are with
preventions and with treatments. That data also provides for us
what the deaths are within that sample area, what the under-
five deaths are. And halfway through, we can go through and
send people out to track down those deaths and do what we call
a verbal autopsy. In other words, you take an expert that goes
back to those homes where the child died and ask the mother a
series of questions, because a child in Africa to have a fever,
it can be any number of things. Half the time it is going to be
malaria in these areas. But it could be meningitis, it could be
any number of things, so they ask: Was the child vomiting? Did
their neck hurt? Were they stiff? And they collect that data,
they send it back to a panel of experts, who will do what
they--that is part of the verbal autopsy, who make a pretty
accurate determination of whether they think it was a malaria
death or not.
With that data, what we can--coverage data, is IRHS being
implemented effectively? Is the insecticide being watered down,
diverted, or are people missing, are people not understanding
what we are doing? Are people using their nets for other
things? Sometimes people leave nets in the bags. It is the only
thing they own. It is the only thing that has been produced
that is new, and they would rather keep it than use it because
they don't have the education. So we make sure people
understand how they have to do this on their own. We can make
corrective adjustments then, and also at the end of the year
three, we can also go back and do another assessment of what
the coverage issues are, whether IRHS, nets, and the treatments
are doing what we say we need.
So we have several chances within that time to make
corrective actions, so that plus the surveillance data, which
will take a little more time to explain, we have a pretty good
sense of where we are. So by the end of year five, at the end
of the day, I think we can say with a pretty high level of
confidence if we are meeting those targets or not, or even at
the end of year two, if we need to take corrective actions that
soon.
Senator Carper. All right. Thanks very much.
Mr. Miller. You are welcome.
Senator Carper. Thanks, Mr. Chairman.
Senator Coburn. I have three real quick additional
questions. You related to our staff that the programmatic
environmental assessment should be completed in March, and you
still feel comfortable with that? The programmatic
environmental assessment?
Mr. Miller. Right, we do, yes, and that is probably worth
explaining real quickly. That is, in the environmental
assessment period for leading up to spraying, what we have
decided to do is try to make life a little easier on these
country plans and take and do one large assessment, the types
of assessments that we need across the board, a toxicity,
chances of leakage--we use international standards--potential
harm to fisheries, things like that. So the country plans can
go and have a greatly reduced assessment burden.
Senator Coburn. Right.
Mr. Miller. So, yes, we are still sticking by that.
Senator Coburn. And I understand there is underway a search
for a malaria czar, somebody to take charge of this. As a
country, we are going to have three times the investment on an
average. We are going to go to about $350 million a year in
terms of malaria.
I am wondering, what are the characteristics for the person
that you are going to fill that? I sit and look as a physician
at the failed strategies in Africa, and I am wondering if we
ought to be choosing an infectious disease expert that was not
associated with a failed strategy.
Mr. Miller. Right.
Senator Coburn. I would just put that out as a comment. If
we go from back inside of the failed strategies, I think we
lose confidence, first. I can tell you I will lose confidence.
Second, is new ideas, fresh ideas, and new invigoration will be
helpful. So I am interested in that.
Then, finally, my final question is one of the other big
problems that we are facing in Africa is tuberculosis. And can
you relate to me--and I know this hearing is not on that, but
are there plans ongoing in USAID to expand our help on that
dreaded disease?
Mr. Miller. I will start backwards, on the TB. I can't tell
you off the bat what our projections are on TB. But I agree
that, when we were planning PEPFAR--I was actually in a
different position at that time--and also here on the Hill,
people identified--we used to call them ``the big three'' in
Africa. They are very commonly associated with each other. If
someone has HIV, there is a good chance you are going to die of
TB or malaria. So it is very reasonable to say that as we are
dealing with AIDS and malaria, we would also benefits from
taking a look at TB. I am not offering any criticisms right off
the bat, but I do want to recognize that, yes, it makes sense.
Now, on the coordinator, I agree with you. We are not
looking to enforce or reinforce the status quo. We are looking
to change the way Americans view our role in fighting malaria
worldwide, the way the world views our role. So we have to have
a leader. Someone with public health expertise I think would be
helpful, but as we have seen with many leaders in public
health, it is not necessary. I do not come from a public health
background. My boss does not. Ambassador Tobias does not. So it
is not required. If you surround yourself with real
professionals--and we do--it is really qualities of leadership,
someone who understands opportunity, someone who can push the
issues for IRHS, for example, someone who can do that not just
here within USAID or within an interagency but also globally.
That search is ongoing. There are some candidates, but
presumably we have our own leadership change coming up, and it
will have to be at least connected to that.
So I would have liked to have had one by now. That is not
for lack of trying. And certainly by next year, when we ramp up
to $135 million within the PMI and go up to presumably--
potentially up to $200 million overall, it is an incredible
amount of responsibility. We have to staff up some more
internally. We will want somebody that has leadership and has
the experience, and our job now, I think we see it as we get a
program up and running that we can hand over to that person,
that there is minimal distractions, minimal corrective action
that will have to be taken.
Senator Coburn. All right. Thank you. I am going to have
about four or five other questions that I will submit to you in
writing, if you would get those back to us in a couple of
weeks.
Mr. Miller. I would be happy to, yes.
Senator Coburn. I would appreciate it
Senator Carper, do you have additional questions?
Senator Carper. Just one, if I could.
In your opinion, what role should malaria experts and
African governments be playing in defining where house spraying
should be used? But before you answer, let me give you sort of
a second part. Do you have any concerns that legislating that a
percentage of U.S. funding be for spraying, taking out of the
equation both African governments who may better understand
logistics in their particular part of the world, and experts
who may best understand which sprays or which nets or other
tools may work best?
Mr. Miller. I think in any circumstances, answering
generically, we want to have experts as closely associated with
the planning as possible. I think the best way to go about it
is to start with the idea that we believe spraying has been
underutilized in Africa. Personally, I believe everything has
been underutilized in Africa. That is part of the problem.
In the 1950s, when a panel of experts, a WHO panel of
experts, and the donors decided that Africa was simply too
difficult to undertake the eradication--and eradication was the
aim then--to undertake the eradication programs in Africa, as
we did on many other continents, we were literally decades
behind. And what we found is in these countries, as the
Ugandans told us very clearly, there is very little expertise
on indoor residual spraying. Some people remember it. Some
people are very enthusiastic about it. A lot of people don't
know about it. And the expertise within the National Malaria
Control Programs varies quite a bit. And I think the attitudes
toward indoor residual spraying varies quite a bit.
One thing that we have observed internally is that the
National Malaria Control Programs' posture toward indoor
residual spraying very often reflects the prevailing opinions
of outside experts who are hired as consultants to help write
them. So it's going to be a real grab bag of opinions.
Predominantly, the opinion is that IRHS does not have a role.
We don't agree with that. Most Africans don't agree with that.
It is not universal.
In the case of Tanzania, for example--Zanzibar, rather, it
was USAID staff that said, Why don't we try an indoor residual
spraying campaign here as well? They said that is a good idea.
In Uganda they have a very clearly defined plan where they have
planned over long periods what to do, and we come in behind
that without much questioning. It can be expanded or it can be
limited, depending on it. But I think it is fair to say that
the level of expertise on IRHS worldwide, particularly in
Africa, is pretty spotty, and we need to support that. We need
to support more interventions across the board, not just IRHS
but more interventions, more attention on malaria from all
donors.
Senator Carper. All right. Thank you very much. And thank
you for the report.
Mr. Miller. Thank you.
Senator Coburn. I would just note that there is great
scientific data that proved the effectiveness of IRHS in terms
of controlling malaria.
Mr. Miller. I agree.
Senator Coburn. Reductions by 50 percent in the death rate
among those where it has been utilized properly. And that is
what we are talking about. We are talking about saving those
kids' brothers' and sisters' lives. And it is effective. And it
is not about mandating the percentage. It is about having more
than 8 percent of the budget go to actually making an impact in
the disease.
Mr. Miller. Right.
Senator Coburn. That is what it is about. Mr. Miller, thank
you very much.
Mr. Miller. My pleasure, sir.
Senator Coburn. We will submit some questions. Thank you
for coming before us, and congratulations on a job well done.
Mr. Miller. Thank you very much. Thank you, Senator.
Senator Coburn. I would like to thank our next panel. We
have three witnesses. I want to personally express my
appreciation for you coming. We have Simon Kunene, Malaria
Program Manager, Swaziland Ministry of Health. Mr. Kunene has
directed Swaziland's National Malaria Program since 1993. He is
the Chairperson of the Southern African Development Community
Subcommittee on Malaria. He also serves as a consultant to the
World Health Organization on vector control and indoor residual
spraying for malaria control. I appreciate very much the
distance that he has traveled to come to be with us. I know
what that long ride is like, and to share the lessons that you
have learned from being involved with this in the field.
Next is Dr. Don Roberts, Professor at the Uniformed
Services University of the Health Sciences. Since 1986 Dr.
Roberts has been a professor at the Division on Tropical Public
Health. He has authored over 100 peer review publications. Much
of his research is focused on malaria control methods,
specifically on indoor residual spraying. I appreciate the
scientific expertise he will share with the Subcommittee.
Next is Dr. Andy Arata, Vector Control Specialist. Dr.
Arata serves as a consultant to USAID and the World Bank
projects involving vector-borne disease and their control. He
has previously held a post as professor in the Department of
International Health and Development at the Tulane School of
Public Health and Tropical Medicine. He has served as the
Deputy Project Director of the Environmental Health Project
funded by USAID, and has over 30 years of experience
consulting, managing, teaching, and researching in the field of
tropical diseases and vector control. I look forward to hearing
about lessons learned from his extensive career.
I want to welcome you all. Your full testimony will be made
a part of the record, and you will be recognized. We would like
for you to limit to 5 minutes. If you go over, we are OK. We do
not have any votes that we are going to have to worry about
today.
Mr. Kunene.
TESTIMONY OF SIMON KUNENE,\1\ MALARIA PROGRAM MANAGER,
SWAZILAND MINISTRY OF HEALTH, AND CHAIRMAN OF THE SOUTHERN
AFRICAN DEVELOPMENT COMMUNITY SUBCOMMITTEE ON MALARIA
Mr. Kunene. Thank you, Mr. Chairman. Thank you very much
for inviting me to give this testimony today, and I hope this
hearing will lead to a better understanding of what Swaziland
is doing or has done in malaria control, and how the U.S.
Government can better assist other African countries, including
Swaziland, to save lives.
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\1\ The prepared statement of Mr. Kunene appears in the Appendix on
page 00.
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As my written testimony explains, Swaziland's main
intervention in malaria control is indoor residual house
spraying, and this method of control has been highly effective
for many years, and was first introduced shortly after the end
of the Second World War.
As a result of the successes and a reduced pattern of
malaria, funding for malaria control was reduced significantly
in the 1980s. Indoor residual house spraying coverage declined,
and malaria cases and deaths increased.
In 1986 and 1987, the government of Swaziland, along with
some partners, which included the World Health Organization,
the South African Trade Mission and USAID, reinvigorated
malaria control. This relaunched program was, and is still,
mainly based on indoor residual house spraying and provision of
effective drugs. And recently we have introduced insecticide
treated nets in our program.
We now have a very wide coverage, Mr. Chairman, of IRHS,
and with more than 90 percent in targeted areas is now coverage
achieved. We use DDT and synthetic pyrethroids, which continue
to be highly efficacious and cost effective.
An innovation of our program is to use geographical
positioning system, GPS, to enhance planning, monitoring and
evaluation of our malaria control activities. The introduction
of GPS in our program ensures that limited resources are put to
the best possible use. With support from the Global Fund we
recently introduced ITNs, targeting pregnant women and children
under five years of age.
To ensure that we achieve the appropriate targets, these
nets are distributed to the high risk groups free of charge. We
strongly believe that IRHS and ITNs complement each other. In
other words, ITNs are not a replacement for IRHS and vice
versa.
Malaria case management remains very critical if we are to
reduce malaria morbidity and mortality. This requires that
health personnel are properly trained in the management of the
disease, and there should be a consistent supply of drugs. The
Kingdom of Swaziland, over the years, ensured that all anti-
malarial drugs are available at health facilities, and the
distribution and administration of these drugs remains the
responsibility of health professionals.
The consistent implementation of IRHS and the limitation of
antimalarial drugs to health professionals have probably
contributed to the slow development and spread of chloroquine
resistance in the country. It is against this background that
the chloroquine remains the drug of choice. However, the
country has taken a decision to introduce ACT in the country,
not because of resistance, but because of the added advantages
of ACTs.
Malaria is very unstable in Swaziland and epidemics are
very common in the years of favorable conditions for
transmission. It is, therefore, crucial that we have a very
sound disease surveillance system in place to pick up any
abnormal situations.
Our decisions on malaria control are based on scientific
evidence. Therefore, we monitor drug and insecticide
resistance, and we work with international institutions in this
regard.
The effective implementation of the above has ensured that
the pattern of disease is maintained at acceptable levels. For
example, clinical malaria cases have been reduced from 45,000
in 2000 to over 5,000 in 2004. Malaria admissions have fallen
from about 1,800 in 2001 to fewer than 200 in 2004. There were
less than 10 malaria deaths in 2005. We now have a situation
where a single malaria death becomes a news item.
The Kingdom of Swaziland works closely with other partners
in the Southern African Development Community. An important
factor in our success has been the inter-country collaboration
with South Africa and Mozambique in Lubombo Spatial Development
Initiative. This is an initiative that has been highly
successful and is based on IRHS, effective drugs, good disease
surveillance and capacity building. These interventions have
resulted in significant reduction in the pattern of the disease
in the three countries.
The inter-country collaboration shows what can be achieved
when the right interventions are chosen, and when good
operational research supports decisionmaking.
We would like to see a situation where a far greater
proportion of U.S. Government support for malaria control goals
on commodities. That will have an immediate impact on malaria
cases and deaths. We would also like the U.S. Government to
promote policies that will provide essential commodities, such
as ITNs, free of charge to the vulnerable groups. I would also
like to see the U.S. Government taking a more active role in
positively promoting this intervention, which has been degraded
over the years. We also need a clear position on the use of
DDT, whether or not U.S. funds can be used to purchase this
insecticide. We also would like to appreciate U.S. support in
the research, development of alternatives to DDT.
Finally, Mr. Chairman, we strongly believe that U.S.
Government supported malaria initiative should fit with
country's own strategic framework instead of being imposed on
them for sustainability.
Thank you for the opportunity to give evidence today, and
for your interest and leadership on this issue. I thank you.
Senator Coburn. Thank you very much. Dr. Roberts.
TESTIMONY OF DONALD R. ROBERTS, Ph.D.,\1\ PROFESSOR, DIVISION
OF TROPICAL PUBLIC HEALTH, DEPARTMENT OF PREVENTIVE MEDICINE
AND BIOMETRICS, UNIFORMED SERVICES UNIVERSITY OF THE HEALTH
SCIENCES, BETHESDA, MARYLAND
Mr. Roberts. Thank you, Chairman Coburn, for the
opportunity to present my views on malaria and DDT this
afternoon. As a government employee, I am required to state
that my comment should not be construed as reflecting the
opinions of my university, the Department of Defense, or the
U.S. Government.
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\1\ The prepared statement of Mr. Roberts appears in the Appendix
on page 00.
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In preparing my comments I was reminded of a statement
often used in discussions of controversial issues, namely, that
each of us is entitled to our own interpretations, opinions,
and ideologies, but we are not entitled to our own facts.
Certain basic facts about DDT and malaria control might help
focus our thoughts and discussions.
DDT is sprayed on the inner walls of houses to control
malaria, and this is referred to as indoor residual house
spraying, or IRHS. When sprayed on walls, DDT acts primarily as
a spatial repellent. This spatial repellent action stops
mosquitoes from entering houses and transmitting malaria while
people sleep. DDT is moderately toxic to mosquitoes, but
toxicity is not its primary mode of action. Our research shows
that mosquito resistance to DDT toxic actions does not
neutralize DDT's spatial repellent action. Thus, DDT is
effective in the control of malaria even when the mosquitoes
are resistant to its toxicity.
Some people argue against house spray programs and the use
of DDT solely on the basis that poor or less developed
countries do not have the infrastructure or people trained to
administer such programs.
To the contrary, many malaria endemic countries started
malaria control program operations on their own initiative in
the 1940s. Those pioneering programs were quick-starts, and the
managers learned valuable lessons as the programs progressed,
and the programs progressed quickly. It seems reasonable to me
that if poor countries created such programs 60 years ago,
governments can do the same thing today.
Another argument against indoor spraying is expense, that
it's OK for urban areas, but that indoor spraying is just too
expensive for rural areas. Well, malaria is a rural disease.
The truly significant value of DDT in the 1940s was that it
offered, for the very first time, an affordable method of
protecting rural households from malaria. In fact, any claim
that indoor spraying is ineffective or cannot be used in rural
areas because of cost, is simply not consistent with the
historical experience.
There has been a lot of discussion about DDT's usefulness
in areas where mosquito vectors show variable levels of
resistance. I have already explained that DDT does not function
by killing mosquitoes, so DDT resistance does not impair its
mode of action, that of spatial repellency.
Regardless, let us assume there is evidence that DDT
resistance is a problem. The best way to evaluate the problem
is to spray DDT and monitor its effect on malaria cases. I
suppose we could call this a trial and error method. If DDT
does not control disease, then use another chemical. If it
controls disease, then it works, regardless of any finding of
resistance.
I propose a similar method to address claims that DDT is
not effective under some epidemiological conditions. This trial
and error method is consistent with advice of one of the
world's most famous malariologist. In a presentation before the
Royal Society of Tropical Medicine and Hygiene in 1949, Dr.
Arnoldo Gabaldon admonished the audience that DDT's
effectiveness should be judged on reducing malaria cases, not
on reducing mosquitoes.
Additionally, this trial and error method is in line with
funding objectives of the President's Malaria Initiative, that
is, disease control, not mosquito control.
I will end my testimony with a historical perspective on
leadership for USAID's new malaria program. Before DDT house
spraying began, almost 2 billion lived in malaria endemic areas
and were at risk of malaria. Even before the global malaria
eradication became functional in 1959, DDT house spraying freed
roughly a third of a billion people from endemic malaria. By
1969, only 9 years later, DDT house spraying had freed another
two-thirds of a billion people from endemic malaria, almost one
billion people living without the daily threat of endemic
malaria.
Now, let's look at the Roll Back Malaria Initiative, which
began in May 1998 and is now in its eighth year. I cannot
figure out what the initiative has accomplished, and numbers of
malaria cases have actually increased during the last 8 years.
Eight years is a precious long time for those who are at
constant risk of disease and death from malaria.
In concluding my comments, I want to say that I hope the
person selected to lead USAID's malaria program will not be wed
to the Roll Back Malaria approaches to malaria control.
Thank you.
Senator Coburn. Thank you, Dr. Roberts. Dr. Arata.
TESTIMONY OF ANDY ARATA,\1\ VECTOR CONTROL SPECIALIST
Mr. Arata. Thank you, Chairman Coburn and Members of the
Subcommittee on Federal Financial Management, Government
Information and International Security, for the opportunity to
speak before you today and to present my perspective on malaria
control and progress in malaria control programs.
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\1\ The prepared statement of Mr. Arata appears in the Appendix on
page 00.
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As you mentioned in your statement, I have spent over 35
years working in malaria and vector-borne disease control,
working for a number of international organizations in over 30
different countries.
I began my WHO career at the actual peak of the Malaria
Eradication program in the 1960s, and worked for WHO on new
control methods, particularly biological control in the 1970s,
and I have served as a consultant evaluating malaria control
programs in Africa, Latin America and Asia, for USAID, WHO, and
the World Bank.
I am really quite pleased to see that U.S. foreign aid in
malaria control is reconsidering the use of indoor residual
spraying and DDT. For a number of years I have felt that the
almost sole approach to vector control through the employment
of insecticide treated nets, the ITNs, was very shortsighted,
producing positive, but limited, results.
In general, I and many field-oriented colleagues have
proposed integrated control measures, employing more than one
approach to vector control, depending upon the ecology of the
vectors in each specific area. This approach is employed not
only for malaria control but for the control of other vector-
borne diseases such as dengue, yellow fever, West Nile, as well
as nuisance insects. Integrated control is also used
extensively in agriculture, and we have a lot to learn from
that. For malaria vectors, integrated control may include
larval control by chemical or biological insecticides,
elimination of breeding sites, especially man-made, in
irrigation ditches, ponds, rice paddies, etc., housing
improvements, ITNs, depending on the characteristics in vector
ecology in a given area.
Malaria is a very variable disease. There are four
different parasitic species and numerous anopheline vectors--
40-50 vectors more or less, and a range of transmission
intensities from endemic to stable to unstable, to variable
biting patterns in terms of where and when the mosquitoes
prefer to bite, resistance potential for both the parasites to
anti-malarial drugs and the vectors to insecticides. We also
have both forest and urban transmission patterns. In other
words, measures that work in Southern Africa may not
necessarily work in the Congo. The variety of circumstances
facing the control program manager in the field is huge. On top
of these factors, there are other complexities; differences in
housing construction material, whether wood, mud, etc. These
will modify the efficacy of any insecticide, so depending on
only a single compound or a single method of application is, in
my opinion, a recipe for failure.
My career in malaria control has spanned from the
eradication era through the reemergence of IRHS as a major
control measure. To my mind, the overriding lesson of the
malaria eradication period, has been that there was no ``magic
bullet.'' Local variations mattered, and a flexible approach,
what I have called ``integrated control'' was the most
effective. In many instance malaria programs of the past were
problematic and what we might refer to as cookie-cutter. They
tried the same thing in country after country without any
variation or consideration of local problems.
Sole reliance on IRHS with DDT did not work well, and we
now have more tools available to us than we did earlier. The
bed nets and the newer drugs for malaria treatment offer new
opportunities for effective control measures using integrated
approaches tailored to local circumstances and vector-specific
variables. Integrated control also implies the development of
infrastructure and management practices, as well as community
participation, and even appropriate diagnosis and treatment.
I hope that those charged with the development of new
malaria control programs will see their way to employ DDT as
they would any other insecticide, to be tested and evaluated
for efficacy, for safety and cost in each situation. I think
DDT has a role to play in malaria vector control, and if it is
used particularly as a component in integrated control systems.
Thank you, sir.
Senator Coburn. Thank you, Dr. Arata.
Mr. Kunene, you have an integrated program, do you not? You
have impregnated nets and indoor residual spraying. We saw from
the data you presented to the Subcommittee this marked
reduction in infection, marked reduction in hospitalization and
marked reduction in deaths. Is that correct?
Mr. Kunene. Yes.
Senator Coburn. When Dr. Arata talks about an integrated,
would you describe the system in your country as an integrated
system?
Mr. Kunene. Yes. I think we fully support an integrated
approach. As I mentioned in my presentation, we use IRHS, then
we use ITNs. ITNs are targeting pregnant women, which are
considered a vulnerable group, and children under five. So if
we were to use ITNs and ignore IRHS, we probably would be
covering about 20 percent of the total population at risk
because pregnant women plus children under five, I think they
contribute about 20 percent. So you will have about 80 percent
of the population not covered or not protected.
So with the IRHS we are able to cover the 80 percent, which
is not covered by the ITN program. So integrated, we fully
support.
Senator Coburn. And it is true, the same program you are
using has been used in South Africa as well. Where you have
countries today, where we are not doing anything, we are not
seeing anything done, does it makes sense to apply what is
being done until we figure out an integrated strategy? Nobody
is wanting to use a cookie-cutter approach, we understand that,
but we also understand that a lot of the buildings in your
country have disparate different materials that are part of it,
and there is no question they absorb at a different rate, it
lasts varying lengths of times in terms of the application of
indoor residual spraying with DDT. But the fact is it acts as
an irritant and repellent in very small quantities. Is that
true?
Mr. Kunene. Yes.
Senator Coburn. So what is working somewhere now is better
than nothing happening where people are dying by the thousands.
Mr. Kunene. I think there is attempts--as the Chairman has
mentioned, we are treating it as a solution, that these two
interventions will never replace each other. They complement
each other. And as the region, South Africa, I strongly believe
that is what even our minister has decided, and DDT remains the
insecticide of choice, not only for South Africa, Botswana and
Namibia. Zambia has just relaunched IRHS, and they have seen
significant results in terms of reduction of malaria mortality
and morbidity.
We are now moving towards maybe Malawi, Tanzania, the whole
sort of region, I think will move towards IRHS, IRHS as method,
that the choice of insecticide, we leave that to the countries.
They can do their own recommendations. What would be affordable
to us, and what would be more effective, but IRHS as the
method.
Senator Coburn. Thank you.
Dr. Roberts, Dr. Arata asserted that DDT should be tested
like other insecticides and evaluated. Do you have any comment
on that?
Mr. Roberts. I do believe that there is a role for pilot
testing in areas where there are no recent test data for the
effectiveness of DDT in an indoor residual spray program. So it
seems to me that would be an intelligent way to proceed, doing
pilot testing.
On the other hand, it is somewhat difficult to reconcile a
slow approach in a setting where just literally thousands of
people are dying. So it seems to me that this is one of those
situations where outsiders should step back and let the
countries make those decisions, how do they want to proceed,
and then support them in any way possible, whether it is DDT or
another insecticide.
Senator Coburn. Mr. Kunene, you testified that DDT has been
your primary insecticide, is that correct?
Mr. Kunene. Yes.
Senator Coburn. And how many years since your program
began? That is 6, 7 years ago; is that correct?
Mr. Kunene. It was introduced in 1946.
Senator Coburn. I understand that, but the reuse of it
really started, your numbers started coming down starting in
2000, correct?
Mr. Kunene. Yes.
Senator Coburn. Have you all seen adverse health impacts
from the use of DDT in your country?
Mr. Kunene. As I mentioned, we are working in collaboration
with the Swaziland Environmental Authority, which is a
government wing, and they are the ones monitoring our
responsible use of the product. And over the years they have
not indicated that there are any adverse health effects as a
result of the use of DDT in the country.
Senator Coburn. Dr. Roberts, do you know of any publication
of scientific data, peer-reviewed, that shows adverse health
effects from indoor residual spraying of DDT?
Mr. Roberts. I do not. Could I amplify?
Senator Coburn. Sure.
Mr. Roberts. I do not know of a published peer-reviewed
article that shows that there is an adverse human health effect
from indoor residual spraying with DDT. But I would like to add
to that that I have actually been told by, for example, the
head of the NIH in Mexico, that they have looked at that
extensively because of the very considerable environmental
pressures that were applied in Mexico to stop the use of DDT in
malaria control. His comment to me--this was March of last
year--was that they have found nothing.
Senator Coburn. Dr. Arata, are you familiar with any peer-
reviewed scientific data that would suggest that?
Mr. Arata. No, I am not. We do know, of course, from an
environmental standpoint, there are risks to be taken, but even
there, the vast majority of the problems are associated with
excessive use in agriculture, forestry, and the like. In
general, public health use of insecticides in most of the
countries that I am familiar with, developing countries,
usually amounts to only about 10 percent of what is used in
agriculture, and used within the houses in IRHS. It is really
unlikely that it would cause any environmental damage.
Senator Coburn. So you would agree with the program. There
is not any peer-reviewed literature out there on DDT when used
in indoor residual spraying offers any threat to the
environment?
Mr. Arata. Not that I know of.
Senator Coburn. There is not any. We have looked at it.
Mr. Arata. There is none.
Senator Coburn. There is no search that would show that.
So one of the things I wanted to establish for this hearing
is, we do not want to use DDT because it is cheap and because
it works if it harms the environment and truly will make things
worse; we want to use DDT is because it is very effective in
certain areas at controlling the disease. And we have to get
over the hump of the environmental bias against it because of
the lack of understanding of the confined use of this and the
diluted quantities that are used compared to what our
experience was in this country.
When I was a young boy, they used to come down the streets
spraying. The fogs would be out and they would be spraying it.
As a young boy I can remember the massive use of it, and the
massive use of it in terms of agriculture for cotton, things
like that.
Mr. Kunene, would you comment on the importance, what would
it mean in the continent of Africa if America would
aggressively support indoor residual spraying?
Mr. Kunene. Mr. Chairman, I think we would see a
significant reduction of mortality and morbidity as a relate of
malaria in the country. Just IRHS as a principal. If you add
the DDT, I think that will even make it even more successful,
Mr. Chairman.
Senator Coburn. From your perspective, is there something
that our USAID folks can do as they roll out this new program,
looking at it from Africa, what can they do to be quicker, more
efficacious, more effective, and attain greater results other
than what you've heard here today? If you were to sit down and
had a chance to give them advice, what advice would you give
them?
Mr. Kunene. I do not know what the approach is now--I
strongly believe that for when you put money, you must be able
to evaluate whether you are making success or not. Baseline
surveys I think are critical. We do not just come and spray,
then start evaluating later. Let us determine the situation now
from an etymological perspective. What species or vector
species are available, and what is the parasite prevalence for
now, the hospital data? Then will come in with the
interventions.
But when it comes to IRHS implementation, as my colleagues
say, that initial cost will be on the high side considering the
equipment, considering the recruitment of personnel, and we
must invest on personnel. People must be properly trained. I
think in Africa we have the expertise now. And since we are
using some of the insecticides which are very sensitive like
DDT, the responsible use remains very critical, so that is why
the training of personnel is critical.
Ensuring that you establish a very good database. You
should know where to spray. We have moved a step forward
because we are now on GPS. We are plotting all homesteads or
all houses that are sprayed, but that is a very good planning,
monitoring and evaluation tool.
Insecticides, equipment and human resource, that is where
most of the money will come. So I am happy when--I was happy
when I looked at the fact that USAID or the U.S. Government is
considering increasing the cake for IRHS. That is welcome.
Thank you.
Senator Coburn. Thank you.
Dr. Roberts, in your testimony you talked about what
history has taught us what happened in the 1940s and 1950s and
the effective use. And your proposition was, let us do it and
see what happens with the trial and error approach. One of the
things I have heard, as I followed this issue for a couple of
years, is integrated control sometimes is a code word for
everything except IRHS. We will do everything, but we are not
going to do indoor residual spraying. When you hear the words
``integrated program,'' what comes to mind?
Mr. Roberts. Unfortunately, that is what comes to mind,
that it is a code word for let us do anything but IRHS. And
there are some examples out there that vividly illustrate that.
There is a program going on in Central America. The Global
Environment Facility funds, I think it is a $7 million project.
There is no question, if you read through the document for the
GEF project in Central America, there is no question that the
design and the goal of that project is to eliminate the use of
insecticides in malaria control.
And there have been statements even in WHO literature, and
the WHO staff, in exchange of communications with me, that show
very clearly that the goal is with integrated vector
management, IVM, is that the goal is to reduce the use of
insecticides for disease control.
Furthermore, there is a World Health Assembly resolution
that specifically calls on the countries to reduce their
reliance on the use of insecticides for disease control.
My own personal opinion is that it is an awful resolution,
and I do not understand how it was ever adopted by the World
Health Assembly. That is the ultimate governing body for the
World Health Organization, a decisionmaking body, so the World
Health Organization is functioning under a resolution that
calls on countries to reduce reliance on the use of
insecticides.
Senator Coburn. I would like all of you to answer this,
given your extensive experience. If we had a program as
outlined--it looks like we are going to--which is really going
to be a balanced program to use for interventions to impact
this, and it would end up being dominated by impregnated nets
and IRHS and then treatment, would the rest of the world
follow? What do you think?
Mr. Roberts. I will comment. I think so. I gave a
presentation before the Ministry of Health in Thailand in
November, and I was talking about the need for the use of DDT.
This is not a specific answer to your question, but in general
I think it is, and an individual from the political section of
the Ministry of Health stood up and said that the world is not
going to make any move at all to restarting the use of DDT in
these critical programs unless the United States shows
leadership. I take it from that, is that it will make a
difference if we can show change and flexibility.
Senator Coburn. I think Dr. Kunene testified to the fact
that you have to have--we are not talking about indiscriminate
use of DDT, we are talking about trained use and utilization of
DDT in terms of indoor residual spraying. I believe you also
testified earlier that we saw tremendous results from the use
of DDT in the rural areas in terms of IRHS in the 1940s, 1950s
and 1960s. Dr. Arata, would you want to comment?
Mr. Arata. Regarding the role and the position of WHO, I do
not speak for WHO, but I might mention a couple of things. The
resolution reducing the amount of insecticide usage has to be
taken into context. For one thing, programs like the
onchocerciasis control program (OCP), used a large amount of
insecticides, which was replaced by ivermectin as a drug, so
therefore, they no longer needed the same amounts of
insecticides. The same thing is happening with control of other
filarial diseases, with diethylcarbamazine being used for
treatment in urban areas, for example, rather than vector
control, so no need to specify which vector-home diseases that
may also use insecticides are we talking about.
Integrated programs do not come as code words to me, nor to
most of the people that I work with. Integrated vector control
just means using more than one type of vector control measure.
Then you can have integrated malaria control, which integrates
vector control and the diagnosis and treatment. And then you
can have integrated health programs where through sentinel
sites and through clinics, one treats a multitude or a number
of different problems.
So really, integration is, for me at least, not a code word
for not using something, but rather a very positive thing, and
is really copied after some of the integrated control measures
in agriculture, which are very advanced in terms of economic
analysis and economic modeling, which is a level we have not
reached in public health at the present time.
As far as whether other countries will follow us, I think
that there is a very good chance that they will, but I think
the only way they will do that is if we give them an
opportunity to get involved fairly early in the game, rather
than sending them a program of saying, ``This is what we are
going to do now. Come and join us.'' So I think if we ask for
some cooperation and collaboration in some of the planning, at
least opinions, then I think we will have the leadership role
that we would like. So thank you.
Senator Coburn. Dr. Roberts, one last question. What
happens when we replace IRHS with drugs only? What is the
natural history of that? We do not see resistance for parasites
to ivermectin yet, but it does not mean we will not, correct?
Mr. Roberts. Right. We could look back at our uses, for
example, chloroquinized salt. That has been tried in more than
one location in the world. The one that I am most familiar with
was in Surinam and Guyana and Brazil. The result was almost
immediate resistance to chloroquine, and in that case it was
falciparum malaria, which is the more deadly form.
When you start suppressing the use of insecticides in
malaria control, the truth is, we really only have one major
option for preventing malaria transmission, and that is the use
of insecticides, and breaking man/vector contact inside of
house. And when you eliminate that as an option, really the
government will have only one option or alternative, and that
will be to go with mass drug distribution, what I refer to as
chemoprophylaxis, and that is precisely what has happened in
Central America with this GEF project.
Senator Coburn. Then you have the propensity to develop
resistance.
Mr. Roberts. Exactly.
Senator Coburn. Could I also comment? In many ways I agree
with Andy about integrated vector management. The problem that
we have with the concept of integrated vector management is
that it has, in fact, been used in the wrong way. The concept
is valid. The concept is good, but it has been used to
eliminate the use of insecticides.
Senator Coburn. That has been the goal, rather than to
eliminate disease?
Mr. Roberts. Right.
Senator Coburn. I want to thank each of you. There will be
several questions that will be directed to you. If you would be
so kind as to respond to those, we will not take more time in
the hearing. Our goal is to not see a picture like that, where
it is not there. And if there is anything, $2 for ACT
treatment, $2 to cure somebody of a disease, to spray a room
for a buck, fully absorbed cost, we do not have any reason not
to be successful. I will assure you that we will follow up. I
am very pleased with USAID's response.
Just so they will know, and the others, we had 21
Subcommittee hearings on ineffective spending of the Federal
Government's money last year. We are going to have over 40 this
year in terms of the follow up, and the whole goal is not to be
critical, but to make sure that when we intend to help
somebody, that we really help them, and that we get the most
value for every dollar that the American taxpayer pays, because
in the long run what it does, it makes a difference in those
people's lives. You can see those young children, we did not
make a difference. We did not impact. If 98 percent of what we
spend ends up impacting somebody, then we are the better for it
and so are they.
I thank you for coming, appreciate it very much. Mr.
Kunene, again, the long trip here, thank you for the testimony
of what you are doing in your country, and we congratulate you
on your success. Thank you.
The hearing is adjourned.
[Whereupon, at 4:07 p.m., the Subcommittee was adjourned.]
A P P E N D I X
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