[Senate Hearing 105-520]
[From the U.S. Government Printing Office]
S. Hrg. 105-520
COMBATING INFECTIOUS DISEASES
=======================================================================
HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARING
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/senate
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington DALE BUMPERS, Arkansas
MITCH McCONNELL, Kentucky FRANK R. LAUTENBERG, New Jersey
CONRAD BURNS, Montana TOM HARKIN, Iowa
RICHARD C. SHELBY, Alabama BARBARA A. MIKULSKI, Maryland
JUDD GREGG, New Hampshire HARRY REID, Nevada
ROBERT F. BENNETT, Utah HERB KOHL, Wisconsin
BEN NIGHTHORSE CAMPBELL, Colorado PATTY MURRAY, Washington
LARRY CRAIG, Idaho BYRON DORGAN, North Dakota
LAUCH FAIRCLOTH, North Carolina BARBARA BOXER, California
KAY BAILEY HUTCHISON, Texas
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
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Subcommittee on Foreign Operations, Export Financing, and Related
Programs
MITCH McCONNELL, Kentucky, Chairman
ARLEN SPECTER, Pennsylvania PATRICK J. LEAHY, Vermont
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
RICHARD C. SHELBY, Alabama FRANK R. LAUTENBERG, New Jersey
ROBERT F. BENNETT, Utah TOM HARKIN, Iowa
BEN NIGHTHORSE CAMPBELL, Colorado BARBARA A. MIKULSKI, Maryland
TED STEVENS, Alaska PATTY MURRAY, Washington
ROBERT C. BYRD, West Virginia
(Ex officio)
Professional Staff
Robin Cleveland
Tim Rieser (Minority)
C O N T E N T S
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Page
Opening remarks of Senator Patrick Leahy......................... 1
Prepared statement........................................... 3
Opening remarks of Senator Mitch McConnell....................... 4
Statement of Barry R. Bloom, Ph.D., investigator, Howard Hughes
Medical Institute, and professor of microbiology and
immunology, Albert Einstein College of Medicine................ 5
Prepared statement........................................... 9
Statement of David Heymann, M.D., director, Division of Emerging
and Other Communicable Diseases Surveillance and Control, World
Health Organization............................................ 14
Prepared statement........................................... 17
Statement of Nils Daulaire, M.D., Chief Health Policy Advisor,
U.S. Agency for International Development...................... 21
Prepared statement........................................... 24
Statement of Gordon Douglas, M.D., president, Merck Vaccines,
Merck, & Co.................................................... 28
Prepared statement........................................... 31
Strengthening infrastructure..................................... 34
Statement of John Sbarbaro, M.D., professor of medicine and
preventive medicine, school of medicine, University of Colorado
Health Sciences Center......................................... 34
Prepared statement........................................... 36
Seed money....................................................... 39
Additional committee questions................................... 47
Questions submitted by Senator Campbell.......................... 48
COMBATING INFECTIOUS DISEASES
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THURSDAY, MAY 15, 1997
U.S. Senate,
Subcommittee on Foreign Operations,
Export Financing, and Related Operations,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:41 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Patrick J. Leahy presiding.
Present: Senators McConnell and Leahy.
NONDEPARTMENTAL WITNESSES
STATEMENT OF BARRY R. BLOOM, Ph.D., INVESTIGATOR,
HOWARD HUGHES MEDICAL INSTITUTE, AND
PROFESSOR OF MICROBIOLOGY AND IMMUNOLOGY,
ALBERT EINSTEIN COLLEGE OF MEDICINE
opening statement of senator patrick j. leahy
Senator Leahy. Good morning. This happens with all of us.
Senator McConnell has the usual five different hearings and
meetings going on at the same time and will join us in a bit.
But I do want to note my appreciation to him as the
chairman of this subcommittee for scheduling this hearing. It
is good to have you here, Dr. Heymann. You have come all the
way here from Geneva, and we appreciate that. The fact that you
have done this demonstrates the World Health Organization's
recognition of the need to discuss these issues, which have
been virtually ignored by the Congress.
I looked back 10 years and found one hearing that looked at
the problem of infectious disease from a global perspective.
That is pretty alarming when you consider the regularity of
devastating epidemics throughout history, the potential threat
to the health and economic well-being of millions of Americans
and vast numbers of others, tens of millions more, people all
over the world.
Senator McConnell has pointed out this is an economic
issue, a national security issue, when you consider the threat
of biological warfare and terrorism. And it is of course a
humanitarian issue, and anybody who has traveled around the
world and seen the devastation of some of these epidemics would
know that. I have. My staff has. My wife, who is a registered
nurse, sees more and more patients with infectious diseases,
like tuberculosis, that she did not see 10, 15 years ago.
I also want to welcome the others who are here. Dr. Barry
Bloom cochaired the 1997 institute of medicine study entitled
``America's Vital Interest in Global Health,'' which was very
helpful in preparing for this hearing. Dr. Gordon Douglas, who
brings the perspective of the pharmaceutical industry as
president of Merck Vaccines, has seen the difficulties facing
us especially as more and more diseases become resistant to
drugs we have used in the past.
Dr. Nils Daulaire, is from my own State of Vermont, and Dr.
Don Sbarbaro. You each have a great deal of experience from
your work in public health--you, Dr. Sbarbaro in tuberculosis,
most recently at the University of Colorado School of Medicine;
and Dr. Daulaire from 20 years in primary health care in West
Africa and the Himalayas, now at the Agency for International
Development [AID].
Ms. Laurie Garrett could not be here today because she is
out of the country, but she is the author of the book ``The
Coming Plague,'' which was also the subject of a recent four-
part television series, that has helped spotlight the urgency
of this.
You know, I remember as a child when you worried about
smallpox. I remember as a child growing up in the small city of
Montpelier, VT, when the swimming pool would be closed during
polio scares. But we do not think of these things today. We got
rid of smallpox, we got rid of polio. We thought we had
eliminated all infectious diseases forever. As Laurie Garrett
said:
The world was a very optimistic place on September 12,
1978, when the Nations' representatives signed the Declaration
of Alma Ata. By the year 2000 all of humanity was supposed to
be immunized against most infectious diseases, basic health
care was to be available to every man, woman and child
regardless of economic class, race, religion, or place of
birth.
But as the world approaches the millennium, it seems from
the microbes' point of view as if the entire planet, occupied
by nearly 6 billion mostly impoverished people, is like the
city of Rome in 5 B.C. Our tolerance of disease in any place in
the world is at our peril and, while the human race battles
itself, the advantage moves to the microbes' court.
They are predators and they will be victorious if we, homo
sapiens, do not learn to live in a rational world that affords
the microbes few opportunities. Either that or we brace
ourselves for the coming plague.
aids virus
Mr. Chairman, that plague is already here. By the year
2000, 12 million people will be infected with the AIDS virus in
India alone, 40 million people worldwide. Over 100,000 people
were infected by HIV by 1980, before AIDS was even discovered,
and 3 million people die every year worldwide from
tuberculosis, a curable disease, and now a multi-drug-resistant
form of TB poses a new, even more serious threat.
Each year there are 250 million new cases of malaria, and 2
million deaths. New drug-resistant forms are being transported
around the world.
The ebola virus, if it were to spread beyond isolated
areas, think what it could do. We saw recently the panic in
this city when somebody sent a few overripe strawberries
through the mail. Imagine what would happen if the same amount
of anthrax was scattered from the top of the Washington
Monument.
Over 2 million people each day cross our national borders.
Since 1973 more than 30 new infectious diseases have been
identified.
We need the attention of Congress. America's pharmaceutical
companies can make an enormous contribution to global health,
but they face many obstacles. We need to hear from them what
can be done. We sometimes think that technology can solve any
problem, but it is not that easy.
prepared statement
Mr. Chairman, we have lots of hearings to determine how
many battleships to buy, how many aircraft carriers we need,
how many wings of aircraft we need for our national security.
But there are other threats that cross our borders, and
everybody else's borders. Microbes do not worry about how many
missiles you have aimed at them. They just go right past them.
Thank you, Mr. Chairman.
[The statement follows:]
Prepared Statement of Senator Patrick Leahy
Mr. Chairman, thank you very much for scheduling this hearing. It
deals with issues I have been very concerned about for some time, and I
appreciate the interest you have shown.
I want to welcome our witnesses. Dr. Heymann, you get the prize for
coming all the way from Geneva, and we appreciate that. Your being here
demonstrates the World Health Organization's recognition of the need to
discuss these issues, which incidently have been virtually ignored by
the Congress.
I searched back 10 years, and found only one hearing that looked at
the problem of infectious diseases from a global perspective, which
Senator Kassebaum held two years ago.
That is pretty alarming when you consider the regularity of
devastating epidemics throughout history, and the potential threat to
the health and economic well-being of millions of Americans and vast
numbers of people around the world. As you have pointed out, this is an
economic issue, a national security issue when you consider the threat
of biological warfare and terrorism, and a humanitarian issue.
I also want to thank our other witnesses for being here. They bring
a wealth of expertise, and each has made major contributions in the
field of public health.
Dr. Barry Bloom co-chaired the 1997 Institute of Medicine study
entitled ``America's Vital Interest in Global Health.''
Dr. Gordon Douglas brings the perspective of the pharmaceutical
industry, as President of Merck Vaccines.
Dr. Nils Daulaire and Dr. John Sbarbaro each have a great deal of
experience from their work in the field of public health--Dr. Sbarbaro
on tuberculosis, most recently at the University of Colorado School of
Medicine, and Dr. Daulaire after 20 years in primary health care in
West Africa and the Himalayas, now at the Agency for International
Development.
I also want to mention Ms. Laurie Garrett, who because she is out
of the country could not be here today. But as the author of the book
``The Coming Plague,'' which was also the subject of a recent four-part
public television series, her efforts to focus attention on the urgency
and complexity of the threat of infectious diseases deserves special
recognition.
Mr. Chairman, some of us are old enough to remember the terrifying
days when anyone could wake up infected with smallpox or polio. You can
speak from personal experience. Yet just twenty short years ago, with
the eradication of smallpox and the discovery of the polio vaccine,
people actually thought we were on the verge of eliminating infectious
disease forever.
As Laurie Garrett wrote: ``The world was a very optimistic place on
September 12, 1978, when the nations' representatives signed the
Declaration of Alma Ata. By the year 2000 all of humanity was supposed
to be immunized against most infectious diseases, basic health care was
to be available to every man, woman, and child regardless of their
economic class, race, religion, or place of birth.
But as the world approaches the millennium, it seems, from the
microbes' point of view, as if the entire planet, occupied by nearly 6
billion mostly impoverished people, is like the city of Rome in 5 B.C.
Our tolerance of disease in any place in the world is at our peril.
While the human race battles itself * * * the advantage moves to the
microbes' court. They are our predators and they will be victorious if
we, Homo sapiens, do not learn to live in a rational world that affords
the microbes few opportunities. It's either that or we brace ourselves
for the coming plague.''
Mr. Chairman, in many respects, that plague is already here.
--By the year 2000, twelve million people will be infected with the
AIDS virus in India alone, and there will be forty million
cases worldwide. Over 100,000 people were infected with HIV by
1980, before AIDS was even discovered.
--Each year, 3 million people die worldwide from tuberculosis, a
curable disease, and multidrug-resistant forms of TB pose a
new, even more serious threat. After years of decline, TB re-
emerged as a major public health problem in this country just a
few years ago.
--Each year, there are some 250 million new cases of malaria, and 2
million deaths. New drug resistant forms are being transported
around the world.
--The ebola virus, were it to spread beyond isolated rural parts of
Africa, could cause a similar catastrophe as the AIDS virus.
--And we saw recently the panic caused by a few ripe strawberries
sent through the mail in Washington, DC. One can only imagine
what might result if the same amount of anthrax was scattered
from the top of the Washington Monument.
The cost of stopping these microbial threats at our borders is no
longer a realistic option. To quote from the 1997 Institute of Medicine
study:
``The movement of 2 million people each day across national borders
and the growth of international commerce are inevitably associated with
health risks * * *. Poverty and violence impose major burdens on
health, burdens that are shared by people in developing countries and
in the inner cities of the industrial world alike. Due to the ease of
rapid international travel, emerging and drug-resistant infectious
diseases in one country represent a threat to the health and economies
of all countries.''
Since 1973, more than 30 new infectious diseases have been
identified, and numerous known diseases have re-emerged as serious
public health threats. Our failure to maintain and strengthen our
ability to control the spread of these diseases has recently received
attention, thanks in part to Laurie Garrett's book and films like
``Outbreak.'' Last June, President Clinton announced a national policy
to address the threat of emerging infectious diseases through improved
domestic and international surveillance, prevention, and response
measures.
Other government-funded studies over the past several years have
also warned of the dangers, and made numerous recommendations. However,
as so often happens, many of those recommendations were ignored.
Frankly, I am amazed that this topic has not received greater
attention in the Congress. The Government has a responsibility to
protect its citizens. America's pharmaceutical companies could make an
enormous contribution to global health, but they face many obstacles.
We know what needs to be done, yet we continue to treat one of the most
serious threats we face with the same kind of naive optimism as we did
20 years ago.
Perhaps it is because microbes are invisible to the naked eye, and
we assume that technology can defeat any disease, that we have not done
more about it. I hope our witnesses will explain why things have not
turned out as was predicted back in 1978, what dangers infectious
diseases pose today, and what this subcommittee should do about it.
Thank you.
opening statement of senator mitch mc connell
Senator McConnell [presiding]. Thank you, Senator Leahy.
The reason for our hearing today really is Senator Leahy's
interest on this subject, and he is to be commended for
suggesting it and deserves the credit for this public
discussion today. Having been a victim of polio as a child, I
have a personal interest in this area. I believe we are finally
close to eliminating polio from the face of the Earth, in part
due to a dedicated effort by international health
organizations, bilateral aid programs, and active involvement
of nongovernment organizations and community activists.
But polio should not be the only targeted disease. We need
to see the same kind of effort concentrated on tuberculosis,
malaria, diphtheria, to name just a few. Senator Leahy has
already mentioned this. From my perspective, there are several
reasons to focus our attention and resources on the problem of
infectious disease.
First, it is consistent with our humanitarian traditions.
Right now one person dies every 15 seconds from malaria. Of
those deaths, 85 percent are children under 5 years old. We
need to add malaria, measles, and polio to the short list of
fatal diseases, including smallpox, which we have essentially
erased from the Earth.
This is not just an issue of saving children. The spread of
infectious diseases directly affects both our personal safety
as well as our economic and national security. We need an
effective surveillance system to assure our blood supply is not
contaminated by emerging deadly microbes. At this point we can
screen out well-known bacteria or viruses, but I am not
confident we have the national or international mechanisms in
place to protect us from emerging deadly agents.
We need to coordinate prevention, diagnosis, and treatment
programs for TB, which by some estimates is harbored by more
than 2 billion people worldwide, the majority of whom are in
Mexico, China, and Russia.
Last year we provided emergency assistance to combat the
diphtheria epidemics in Russia and Ukraine. While I think this
aid was helpful, it was a stopgap measure, not a part of a
comprehensive strategy for the NIS.
These epidemics have a human face, but economic cost. Just
as one example, 1995 estimates of health care and lost
production in tropical Africa from malaria run nearly $2
billion, a staggering toll for a destitute continent.
Finally, while some may still be indifferent to the human
or economic interests at stake, there is no question that
improving surveillance, control, and treatment of these
diseases have real national security implications. A few weeks
ago 100 people were quarantined for 8 hours in northwest
Washington in response to an anthrax scare. Pat mentioned that.
While it turned out to be a sadistic hoax, the drill was a live
demonstration of the problems we may face in the future.
In spite of a global convention banning the production,
distribution, or acquisition of biological weapons, 10
countries are suspected of having just such programs. Iraq has
acknowledged manufacturing 25,000 liters of an anthrax
bacterium, which is sufficient to kill the Earth's population
three times over.
I certainly hope we get a better sense today of the
commercial and government research programs which may be
developing vital antidotes, antibiotics, and vaccines to this
threat.
Our panel of experts represents a unique spectrum of
expertise on the extent of the threat and medical and
organizational responses. I understand that Dr. Heymann, who
represents the World Health Organization, is not permitted to
formally testify, so we will accommodate his agency rules by
allowing him to brief us.
I will be leaving for a meeting around 11:30 a.m. Senator
Leahy is going to conduct the hearing and finish it up. Now we
would like to lead off with Dr. Bloom.
summary statement of barry bloom
Dr. Bloom. Thank you, Mr. Chairman, Senator Leahy. It is a
great privilege to be here to talk about infectious diseases in
this committee. I would like to use my testimony to address
three questions to set the background for the discussion of my
colleagues that I hope will follow. The first is: Are
infectious diseases really important? Second: What do we have
to offer to address them and the problems of health of
developing countries? And the third is: What do we have to gain
by it? What is our self-interest?
If one looks at the question of any disease and its
importance, perhaps the best place to look is a comparison of
the global burden of disease, which I have illustrated here.
The bar graphs indicate how many people die of what kinds
of diseases. It makes two simple points. The largest cause of
death in the world is not heart disease, cancer, or injuries;
it is communicable diseases. And the second point is the deaths
are not equitably distributed between the industrialized and
the developing world, but fall predominantly on people who live
in the developing countries.
If one looks then at the burden of infectious diseases in
developing countries and looks in fact at the total burden of
disease, of the eight major causes of death and disability in
developing countries, six of them--respiratory, diarrheal,
perinatal, tuberculosis, measles, and malaria--are the largest
burdens of disease. And if one asks what is the impact of
infectious diseases on the future generation of developing
countries, one finds that 70 percent of the causes of death of
children under the age of 5 are caused by infectious diseases.
So the burden of ongoing infectious diseases is enormous and it
is the major health burden in developing countries.
You have read a lot of media, I am certain, about emerging
infections. The question is is this a major problem or is this
an epidemic of the media? I would simply show you that, if one
looks through history, this is a constant and grim battle
between microorganisms and the human hosts for survival.
These are epidemics that wiped out vast numbers of people
in Europe that have been recorded in history from the Black
Death to 40,000 deaths in Italy to malaria. This is a
continuing evolutionary struggle, not a transient epidemic of
the press.
The second major concern in the area of emerging infections
is drug resistance. Unless there are health infrastructures to
properly use the drugs, we already know resistance is
developing to pneumonia, malaria, TB, HIV, and all of those
resistant organisms threaten the armamentarium at home and our
ability to address these problems.
The final concern that was mentioned in the introductory
remarks is biological terrorism. I could make up a scenario. I
think it is just easier to show a historical scenario, not
intentionally introduced, but could be done by genetic
engineering or by natural evolution. In September 1918 there
was a single case at Fort Devens, MA; 5 days later there were
almost 7,000 cases; 10 days later there were 12,000 cases; 25
percent of the civilian population in the United States was
infected and in fact 40 million people died from that outbreak.
That is not able to be precluded on scientific grounds.
Numbers reflect one aspect. This is a child with cerebral
malaria. This is the kind of malaria that kills children, over
1 million kids each year. That child was too late for medical
help and succumbed.
And 200 million people, as you know, over 1 million kids,
and resistance is dramatically rising.
The first resistance was detected in 1910. It took 60 years
or 50 years for the resistance to chloroquine. We now have
resistance in 4 years in Asia to the only drug available, and
it is my understanding, Senators, that there is not a single
major pharmaceutical company in the world developing drugs
against this disease.
AIDS, as you know, affects a vast number of people and is
the most serious new threat to the health of people in
developing countries. The numbers are staggering. The two that
I would reflect are that 3 million kids have this disease and
have died, and there are at least 9 million children that have
lost at least one parent or are orphaned by this disease, so
that the long-term social as well as health consequences,
particularly in developing countries, are enormous.
This is a disease that affects equal numbers of women and
men in the developing countries, and also children.
And the impact already is that the life expectancy in five
sub-Saharan countries is declining, the first time we have ever
seen a decline in recent years due to a health epidemic.
I am not sure we can get past that.
OK, great.
Finally, there is the problem of tuberculosis. It is the
largest cause of death in the world from any infectious
diseases. It is responsible for 18 percent of adult premature
mortality that could be prevented, and it is emerging as
resistant to drugs and requires major attention.
Senator Leahy. Let me just note Dr. Bloom, that my wife is
a nurse at nearby hospital. She said, in the last 5 years there
has been a steady increase in TB patients. And of course, that
means increased precautions they have to take with special
rooms and care and everything else.
She said that, talking with some of the other nurses of her
age, they have gone for 20 years almost never seeing a
tuberculosis patient.
Dr. Bloom. That is right.
Senator Leahy. And now they are just a very common thing.
Dr. Bloom. And it is sad when it is drug-resistant and we
have no tools to deal with it, so it has to be dealt with. I am
pleased to say the numbers in the United States for the first
time have begun to decline.
What I have said is to argue that infectious diseases are a
major burden in the world and the major burden in the
developing countries. What do we have to offer? I would argue
with a single bit of evidence: this is what we have best to
offer. These are data from the World Bank and they compare per
capita income and life expectancy, and they show two things:
If you are very, very poor, a very small increase in per
capita income, on the left side of that chart, gives you a very
significant increase in life expectancy. Any interventions that
help self-reliance of the poorest will lead to an increase in
life expectancy.
But what we have uniquely to offer in addition is seen on
the right side of the chart. If you lived in 1900, no matter
how much money you had, you could not buy 25 years of life that
we have available to us for the same income in 1990. And since
these are income-adjusted figures, what it says is that
difference, 25 years of life, has to be derived from, in the
broadest sense, public health and medical knowledge. What we
have to offer is a unique expertise in medical knowledge that
buys life.
The Board of International Health then asked the third
question in its report, ``America's Vital Interest in Global
Health'': What is in it for the United States? There were four
reasons that we believe it is within the national interest.
One is, as you well know, a great humanitarian tradition in
this country. And I will not deal with it now, but we could
discuss it later. Many polls indicate the American people are
very supportive of foreign aid if it goes to the neediest, if
it is to increase self-reliance, and if it is to get the job
done that we are trying to get done.
On the other hand, we are concerned, as I am sure you are,
that foreign aid in this country and globally has declined for
6 years and that this may not be a sufficient justification. So
there are three other arguments we have tried to educe.
One is to protect our people.
Some 25 million travelers travel each year; 2 million go
across borders; 148 million are refugees; 10 countries each
have 70,000 refugees each on a permanent basis from foreign
countries and 70 million people work across national borders.
There are infectious diseases. There is urban crowding, and
there is the transport of health hazards, including toxins.
There are three reasons, then, to protect the American
people. I will only mention two. One is the need for
surveillance that you will hear about later, to identify what
the threats are in infection. But the one that I think is the
least understood is value for money.
We tested whopping cough vaccine, not in the United States
but in Scandinavia, because we could get value for money. They
have more cases that we could evaluate. We studied cancer in
China because they have more esophageal cancer than we have
here and we get value for money. That is not foreign aid. That
is common sense.
I will argue in my professional judgment the most important
thing in AIDS that the NIH and Government have recognized is
the need for a vaccine. I believe for ethical reasons we cannot
test any vaccine for AIDS for efficacy in the United States. We
will need to test it in countries that have the highest disease
rates, that cannot afford the drugs that are available. That is
in our vital interest.
Second, prevention is the name of infectious diseases and
prevention not only helps people, it saves money. We save a
vast amount of money not having to vaccinate against smallpox.
We will do the same for polio. Measles is on the agenda. We
save money as we vaccinate our kids here. For every dollar we
put in, we gain in spared health costs $21 to $29. This makes a
lot of sense.
The second--the third argument that the Board on
International Health educed is that the global health economy
is $1.6 trillion. That is 8 percent of the world's economic
product. We are the leader in development of science and new
products. We are not the leader, however, in sales and exports
to developing countries. The Europeans have 75 percent of that
market, and there are major legislative, congressional and
economic constraints to allowing American industry to compete
effectively abroad. And I should also add, there are 2 billion
people in developing countries that have no expertise--no
access to the drugs that are available to people in this
country.
Finally, the last is that we have an opportunity to
increase U.S. global influence in the world. We have the
greatest amount of science and technology. It should be based
on that. That is our comparative advantage. It should be put
into educating people to help upgrade infrastructures in health
abroad. It should be put into organizing and coordinating the
many agencies that have statutory responsibility in the Federal
Government, but, in an uncoordinated way without that
leadership, are unable to deliver that leadership.
prepared statement
If we want to influence the global health community, such
as the World Health Organization, through the United Nations
system, we really ought to pay our dues so that we can be taken
seriously as a leader in that regard.
I have tried to argue simply three points: infectious
diseases are important, enormously important globally; the
United States has unique strengths and capability to make a
contribution; and we have much to gain.
Thank you very much for your attention.
[The statement follows:]
Prepared Statement of Barry R. Bloom, Ph.D.
I am Dr. Barry R. Bloom, an Investigator at the Howard
Hughes Medical Institute and Professor of Microbiology and
Immunology at the Albert Einstein College of Medicine in New
York. At the present time I serve as Co-Chair of the Board on
International Health of the Institute of Medicine of the
National Academy of Sciences, and as Chairman of the Vaccines
Advisory Committee to UNAIDS. I am most grateful for the
opportunity to make a presentation on the importance of global
infectious diseases and international health to this committee.
My testimony will seek to address two questions relevant to
these hearings: What is the global context for the major
infectious disease challenges which my colleagues will discuss
here today? and, Why is it in America's vital interest to
engage in global health activities?
the global burden of infectious diseases
To evaluate the importance of any particular health
problem, it is useful to consider the global burden of
mortality and disease. The major cause of death in the world is
not cardiovascular disease, cancer or injuries, but infectious
disease. [1] If one combines the burden of premature mortality
together with long-term disability, a useful metric can be
derived for measuring the burden of disease and disability,
known as disability adjusted life years or DALYS [2].
Table 1.--The global burden of disease, DALYS
Billions
Established market economies plus former Socialist economies...... 0.161
Developing countries.............................................. 1.220
-----------------------------------------------------------------
________________________________________________
Global total, 1990.......................................... 1.381
Note.--Disability adjusted life years lost (DALYS) equals premature
mortality plus long-term disability.
Using either metric, it becomes immediately apparent that
the global burdens of mortality or disease are not equitably
distributed. The vast burden of premature mortality and
disability falls disproportionately upon people in developing
countries. If one focuses directly on the health problems of
the developing countries themselves, almost 50 percent of the
burden of disease and disability is accounted for by
communicable perinatal and maternal mortality, all of which are
ultimately caused by infectious diseases.
Table 2.--Burden of disease developing countries, 1990
Percent DALYS \1\
Communicable, perinatal........................................... 48.7
Cardiovascular.................................................... 8.2
Neoplastic........................................................ 4.0
Injuries.......................................................... 15.2
\1\ Disability adjusted life years lost.
Of the eight leading causes of death and disability in developing
countries, six are directly or indirectly caused by infectious
diseases, lower respiratory infectious, diarrhoeal diseases, perinatal
conditions, tuberculosis, measles, and malaria. HIV infection is the
disease most rapidly increasing in developing countries.
Of the eight leading causes of death and disability in developing
countries, six are directly or indirectly caused by infectious
diseases, lower respiratory infectious, diarrhoeal diseases, perinatal
conditions, tuberculosis, measles, and malaria. HIV infection is the
disease most rapidly increasing in developing countries.
Table 3.--Global burden of disease and disability ranking causes in
developing countries, 1990 [2]
(1) Lower Respiratory Infections
(2) Diarrhoeal Diseases
(3) Perinatal Conditions
(4) Unipolar Depression
(5) Tuberculosis
(6) Measles
(7) Malaria
(8) Ischemic Heart Disease
If one considers only the burden of mortality on the future
generation of developing countries, children under five years of age,
infectious diseases represent the cause of 70 percent of deaths. Thus,
for the 85 percent of the world's population living in developing
countries, infectious diseases remain a major burden and priority; yet
the scientific and technical means for addressing these problems lie in
the hands and expertise of the 15 percent of the world's population
living in the industrialized world.
The atomic physicist, Leo Szilard, once defined an optimist as,
``one who believes the future is uncertain.'' In addition to the major
infectious diseases that have burdened humanity for centuries, the
media and public have become aware of new and emerging infectious
diseases. To address any concerns that the emerging infectious disease
are a recent invention, or an epidemic of the press, let me remind you
that the grim evolutionary battle between the pathogens and their human
hosts for survival has endured from historic times, and that emerging
infections are not a phenomenon only of recent years.
Table 4.--Emerging infectious diseases--a historical perspective
Epidemic Year
Leprosy........................................................... 644
Smallpox (Rhazes)................................................. 900
Black Death (plague).............................................. 1348
The great pox (syphilis).......................................... 1495
The red sickness (scarlet fever).................................. 1510
Jail fever (typhus)............................................... 1546
Malaria........................................................... 1557
Smallpox.......................................................... 1567
These are but a few of the terrible epidemics of Europe that have
been recorded, that establish the continuing threat of new and emerging
infections entering the human population. Among the newest and most
serious threats are microbes developing resistance to antimicrobial
drugs, often due to their inappropriate use. The drug resistant
organisms are increasingly causing pneumonia, meningitis, malaria,
tuberculosis, sexually transmitted diseases, particularly gonorrhea,
and HIV.
the importance of three major infectious diseases of developing
countries
Of the infectious diseases that are particular burdens for
developing countries, I would like to focus attention on three. Malaria
is a major parasitic disease transmitted by mosquitoes that infects
over 200 million people each year in Africa, Asia and Latin America. It
affects citizens of the United States largely through its importation
with travelers and is a major threat the military stationed in tropical
countries. Malaria kills a million children each year, and resistance
to drugs is rapidly rising. Resistance to quinine developed in 1910,
resistance to chloroquine was reported in 1967 and four years after the
introduction of mephloquine, the newest antimalarial drug, resistance
has developed particularly in Asia. On the ThaiCambodian border, over
60 percent of malaria is resistant to all the anti-malarial drugs.
Because malaria is a disease primarily of developing countries, there
are virtually no new drugs in the pipeline, and it is my understanding
that not a single major pharmaceutical company worldwide is engaged in
developing new drugs for this disease.
AIDS is the recently emergent virus infection that is devastating
the poorest countries in the world, and will continue to do so for the
foreseeable future. UNAIDS estimates that there are 22.6 million people
infected with HIV and 6.4 million have already died of AIDS, including
3 million children. Almost 100 million children have lost a mother or
are orphaned from AIDS. It is a tragic fact that 90 percent of HIV-
infected people live in developing countries that cannot afford the new
and expensive drugs that cost perhaps $15,000 per year. UNAIDS
estimates that 40 million people will have died from AIDS by the end of
this decade. In United States, where the Centers for Disease Control
(CDC) has excellent surveillance figures, HIV is the most rapidly
rising and now leading cause of death of men aged 25-44, and the
picture in developing countries is that women share 46 percent of the
burden of HIV. The devastation of this disease in sub-Saharan Africa is
reflected by the fact that life expectancy in sub-Saharan countries
which had been steadily rising from the mid-1970's has started to
decline and will continue to decline because of the impact which this
disease is having on its young and most productive people.
The third disease is tuberculosis, which remains the largest cause
of death in the world from any single infectious disease. There are
over 7 million new cases each year of tuberculosis, 2 million deaths
annually. In Africa, it is the most common cause of death in people
whose immune system is weakened by HIV infection, and the attributable
cause of death of over 30 percent of AIDS patients there. Particularly
ominous, as we learned recently in New York, is the emergence of
multidrug resistance. We have learned that unless drug treatment is
properly supervised, tuberculosis rapidly becomes resistant to the only
effective drugs available. The lesson was learned originally in
Tanzania and replicated in New York, and showed that directly observed
treatment (DOTS) both prevents emergence of resistance and leads to
cures in over 85 percent of tuberculosis patients rendering them non-
infectious within a month. For malaria and AIDS afflicting people in
developing countries, for which drugs are either not available or
prohibitively expensive, and for tuberculosis where treatment is long,
the long-term hope is for development of preventive vaccines.
four major who extra budgetary programs that can make a difference
For each of these diseases I would suggest that extra budgetary
programs at the World Health Organization, specifically the Tropical
Disease Research (TDR) Program, Global Program for Tuberculosis (GTB),
and the new Programme on Emerging Infections, and the UNAIDS Programma
that unifies efforts of all the UN Agencies, have the potential to make
an enormous difference, and would urge you to give them consideration
for increased financial support. Over 30 years, I have served all but
one of these programs. As Chairman of the Scientific and Technical
Advisory Committee to the Tropical Disease Research Program I was
responsible for reporting to the donor group and the co-sponsors, the
United Nations Development Program (UNDP) and The World Bank, on the
scientific progress and integrity of that program. In my judgment, and
in the words of the representative from the British Overseas
Development Agency, ``there is no program in foreign assistance that
receives a higher level of technical expertise or more stringent
review''. In terms of capacity building, the WHO TDR program has
trained more scientists working in biomedical research in developing
countries than any other program, and over 90 percent of those trained
have returned to their countries. TDR has developed new packages, such
as a Fever Package that can be administered within households, or the
Sick Child Package, that integrates treatment of children with fever
that will prevent deaths from severe malaria, pneumonia and meningitis,
and a package for removing the burden of helminths (worms) that afflict
school children and retards their growth and academic performance, but
they do not have the resources even to test them on a sufficient scale
in developing countries.
I would like to emphasize the work that the new United Nations
Program on HIV/AIDS (UNAIDS) is helping to address the greatest
infectious disease challenge in this era. UNAIDS was established in
1996 to bring together the efforts of six UN agencies and The World
Bank in a common effort to address the international response to HIV/
AIDS:, including the United Nations Children's Fund (UNICEF), United
Nations Development Program (UNDP), United Nations Population Fund
(UNFP), United Nations Education, Scientific and Cultural Organization
(UNESCO) and the World Health Organization (WHO). Although only two
years old, UNAIDS has made a significant impact in disease prevention,
policy development and public-private sector partnerships. There is
encouraging evidence that well defined prevention efforts can lead to
substantial progress in reducing HIV transmission. Declines in HIV
prevalence in military recruits in Thailand and among pregnant women in
Uganda indicates that with a well designed and organized program can
achieve significant progress in reducing HIV infection and
transmission. UNAIDS work in Vietnam, Ukraine and Pakistan has
encouraged these governments to undertake large scale AIDS prevention
programs, and UNAIDS has helped national partners to plan and carry-out
programs to improve blood supply safety and institute medical care for
curable sexually transmitted diseases. Because of increased awareness
generated by UNAIDS efforts, some major companies in the private sector
are working to protect and educate their work forces, especially in
emerging markets. Shell Oil for example is assisting the Botswana
national HIV/AIDS educational program, Levi Strauss is working on a
major AIDS education program for supplying communities in Southeast
Asia.
The Global Program on Tuberculosis at WHO has introduced directly
observed therapy (DOTS) into China, Bangladesh and several countries in
Latin America with dramatic results. Reported cure rates have been over
85 percent, and transmitting the design and operation of such programs
is strengthening the healthcare infrastructures in those countries in a
sustainable way. Without such carefully designed programs drug
resistance will increase. Because of the cost-effectiveness of
prevention through immunization, the GTB has a major need for increased
resources in strengthening the longer term effort to develop and test
vaccines that can prevent infection or disease.
Finally, vaccines represent the most cost-effective known medical
intervention to prevent disease and death. In the United States, we
save $32 million every 20 days by not having to vaccinate against
smallpox [3]. For every dollar invested in measles, mumps and rubella,
$2 dollars is saved in direct and indirect medical costs. For
diphtheria, whooping cough and tetanus, that savings is $29 dollars for
each dollar expended. We know from the Global Programme on Vaccines
deriving from the Expanded Program for Immunization at WHO/UNICEF, that
vaccines can be delivered to children in virtually every corner of the
world. In 1975 fewer than 15 percent of the world's children received
their childhood vaccines. In 1996 83 percent of the world's children
have received childhood immunizations, resulting in the saving of at
least 4.6 million lives. Thanks to partnership of WHO, UNICEF and the
Pan American Health Organization with Rotary International in effecting
polio vaccination in Latin America, the most astonishing result is that
there have been no cases of paralytic poliomyelitis reported in the
entire Western Hemisphere in the past four years. The next target is
the global elimination of polio and initiating a comparable attack on
measles.
why should the united states take a more active role in global health?
The Board on International health of the Institute of Medicine of
the National Academy of Sciences has, over the past year and a half,
examined the role of United States in international health [3]. It
recommended strongly that it was in America's vital interests to engage
more actively in global health activities. In this context, global
health is defined as ``health problems, issues and concerns that
transcend national boundaries and may best be addressed by cooperative
actions''. The Board presented four sets of arguments to support its
recommendation: (i) To fulfill a genuine humanitarian tradition; (ii)
to protect our people; (iii) to enhance our economy; and (iv) to
advance our international interests. A number of recent polls, [4] [5]
have indicated that there is greater than generally perceived public
support for international health and overseas humanitarian assistance
provided, that it goes to those most in need, and accomplishes what it
is intended to do. Those same polls reveal, on the other hand,
widespread misperceptions among the public that the United States is
spending a great deal more on foreign aid than is the case. For
example, the majority of respondents believed the federal government
was spending more on foreign aid (1 percent of the budget) than on
Medicaid (13 percent of the budget). When informed of the true
circumstance, most favored spending more in foreign assistance that is
the current state. In fact, of the 20 OEDC countries, the United States
ranks last in percentage of gross domestic product expended on foreign
aid, and fourth in the absolute dollar amount [6]. In the global
context, support for foreign assistance has declined for the past
several years, declining from about $83 million to about $71 million
from 1993 to 1993 [1]. Of total foreign aid funds, only about 10
percent is spent on health. The Board on International Health report
argues that with the enormously rapid globalization of trade and
commerce, there is a globalization of risks [3] [7]. Currently, there
are 23 million international travelers each year; 2 million people move
across national boundaries each month. There are 45 million refugees
who are dislocated from their countries or homes, and 70 countries have
more than 70,000 refugees. Over 120 million people live outside their
country of birth, and 70 million people work legally or illegally in
other countries. The impact of this new circumstance is increasing
health risks of transfer of infectious agents for both human and animal
diseases, increased risk of epidemics and outbreaks because of
urbanization and crowding, increased risks through transport and
traffic in toxic substances, including drugs, pesticides, pollutants
and tobacco. And there is the risk of biological and chemical
terrorism.
In fulfilling the government's responsibility to protect our
people, the Board believed that the U.S. must be more active in
supporting a global network for infectious disease surveillance, and in
protecting against existing and emergent infectious diseases in humans
and in animals. Perhaps one example of the actual historical impact of
the influenza epidemic of 1918 will serve to indicate the potential
threat we face from evolutionary or terrorist induced emergence of
infectious disease.
Table 5.--The dynamics of a global epidemic: Influenza, 1919
Cases
Camp Devens, MA:
September 12.................................................. 1
September 18.................................................. 6,674
September 23 (727 deaths).....................................12,604
Note.--In the United States: 25 percent of the civilian population
infected in 2 years. The fatality rate was 4,000/100,000.
Globally: In 6 months there were 40,000,000 deaths. (In contrast,
in the 4 years of World War I, there were 15 million deaths).
This can clearly best be done by supporting the WHO Emerging
Infections Program and enabling it to develop a useful global
surveillance system for early warning of new and drug resistant
infectious pathogens.
In the interest of protecting our people, another reason must be
considered for the United States to be actively engaged in
international health activity. Because of unique opportunities abroad
for gaining medical knowledge or testing new interventions, for example
for testing vaccines against pertussis in Scandinavia, or against
malaria in Africa or AIDS in Thailand, the United States can obtaining
greater value-for-money by trials abroad where the incidence rates of
disease are greater and the time required to obtain a statistically
significant endpoint are greater. In perhaps the most pressing case,
AIDS, most experts in the field agree that, at a time when we do not
yet know how effective the new and expensive drugs will be against HIV
in this country, or whether resistance will emerge to them, it is
essential to develop vaccines, even with significantly lower protective
efficacy than we are accustomed to in measles or polio vaccines, to
combat HIV and AIDS. It is my professional judgment that, because of
the ethical need to offer any individuals in this country who show
evidence of HIV in the blood the opportunity for combined drug therapy,
it is no longer possible to carry out meaningful clinical trials to
determine the efficacy trials of candidate HIV vaccines in the United
States. Hence we are all dependent for such knowledge enhancing the
health and scientific infrastructure in disease endemic countries.
The third set of reasons the Board on International Health adduced
to support increased engagement in global health was its importance to
enhancing our economy. The global health market itself represents $1.7
trillion, that is the equivalent of 8 percent of the entire world
economic output. The global pharmaceutical and medical device markets
represented in 1992 over $220 billion in drugs and $71 billion in
devices [8]. Of that, $44 billion was sold in developing countries.
Despite the fact the U.S. creates more new patents for new drugs and
devices, the European Union had 73 percent of drug exports in
developing countries in 1992. Clearly there are economic and regulatory
barriers to allowing American pharmaceutical and vaccine and medical
device industries to gain access to emerging and developing markets,
and more importantly, preventing the people of developing countries to
obtain access to lifesaving drugs at a price that can be afforded.
There are currently 2 billion people who do not have access to
essential drugs. Social and economic studies by WHO-TDR and others in
Africa have indicated that mothers of children with malaria spend up to
30 percent of their annual disposable income for treatments of their
child's illness, yet fewer than half of the treatments purchased would
be expected, on medical grounds, to provide any benefit whatsoever.
There are major economic constraints that need to be addressed.
Finally, the Board believes that U.S. engagement in global health
provides an important opportunity to advance the United States global
interests. The United States is by any standard the world's leader in
science and technology, and produces more knowledge, publications, and
new medical interventions than any other country in the world. We need
to provide more resources to train the leadership in health in
developing countries, to enable the development of health
infrastructures to make a significant contribution to improving the
quality of lives of people in developing countries, and that will take
continued commitment and support. Despite our scientific and technical
expertise, multiple agencies within the government have statutory
responsibilities for aspects of international health, and there is no
coherent strategy or obvious focus leadership within the United States
government. The Board on International Health recommended an inter-
government agency task force, given the limited and scarce resources
available for global health, to coordinate and focus the activities of
each of the agencies in a more coordinated and effective fashion. In
addition, because the problems in global health are likely to be more
technically and scientifically demanding, and because of the strengths
of the National Institutes of Health and the Centers for Disease
Control within DHHS, the Board recommended further that authorization
and support be provided to DHHS for new initiatives in global health
and coordination between academic institutions, industry, NGO's and
international organizations such as WHO. In this context, the Board
recommended undertaking a significant effort to establish global
surveillance for infectious diseases. Finally, the Board argued that it
is very difficult for the U.S. to exert the global leadership in health
that it could, or even to be taken seriously as a leader in global
health within international organizations, if the United States was
hundreds of millions of dollars in arrears in its treaty-obligations to
the World Health Organization and the United Nations system in general.
Because of our leadership in medical science and technology, the United
States has an important opportunity to influence the international
community, international organizations and developing and
industrialized countries alike to address the health problems of those
most in need. Greater U.S. engagement would serve both the global
health needs, and our own our enlightened self-interest. As the poet
John Donne long ago wrote,
``No man is an iland, entire of itselfe.
Every man is a piece of the continent, a part of the maine * * *.
Any man's death diminishes me,
Because I am involved in Mankind.''
References
[1] World Bank, 1993. World Development Report: Investing in
Health, New York. Oxford University Press.
[2] WHO. Investing in Health Research and Development. Report of
the Ad Hoc Committee on Health Research Relating to Future Intervention
Options. Geneva. World Health Organization, 1996.
[3] Institute of Medicine. 1997. America's Vital Interest in Global
Health, Washington, DC. National Academy Press.
[4] CSPA (Center for the Study of Policy Attitudes). 1995.
Americans and Foreign Aid: A Study of American Public Attitudes.
Baltimore. University of Maryland.
[5] The Washington Post, Kaiser Family Foundation, and Harvard
University. 1996. Reality Check: The Politics of Mistrust. Why Don't
Americans Trust the Government. The Washington Post, 29 January, 4
February, 1996.
[6] OECD (Organization for Economic Cooperation and Development).
1996. New Release 11 June, 1196, Paris: OECD Communications Division.
[7] Wilson, M.E. Travel and the emergence of infectious diseases.
Emerg. Infec. Dis. 1:39-45, 1995.
[8] Ballance, R. Pogany, J. and Forstner, H. The World's
Pharmaceutical Industries. An International Perspective on Innovation,
Competition and Policy. Prepared for the United Nations Industrial
Development Organization (UNIDO). United Kingdom. Edward Elgar. 1992.
STATEMENT OF DAVID HEYMANN, M.D., DIRECTOR, DIVISION OF
EMERGING AND OTHER COMMUNICABLE DISEASES
SURVEILLANCE AND CONTROL, WORLD HEALTH
ORGANIZATION
Senator McConnell. Dr. Heymann.
Dr. Heymann. Thank you, Mr. Chairman and Senator Leahy. WHO
appreciates the opportunity to provide information to the
committee on the critical importance of strengthening
international cooperation and participation in the surveillance
and control of communicable diseases.
In my written statement I have laid out the details of the
global framework for surveillance and control of communicable
diseases. WHO, at the request of its 191 member countries, is
putting this framework in place. Many partners are involved in
this effort--countries, international organizations, business
and industry, national nongovernmental organizations,
scientific laboratories, research institutions, universities,
and the monitoring group of the Biological Warfare Convention.
Page 2 of my written statement outlines four major areas
which are top priority for worldwide attention. They are:
strong national infectious diseases surveillance and control;
global monitoring and alert systems with electronic access to
the WHO information highways on infectious diseases; and
international preparedness.
This first chart shows you that in 1996, just a 12-month
period, 27 infectious diseases outbreaks have added to the
heavy burden of underlying diseases, such as malaria, diarrhea,
respiratory disease, and AIDS. Some of these diseases create
ominous associations, such as TB, which is facilitated by HIV.
Others suggest that infectious agents can effectively jump the
species barrier from animal to man, such as is the case of BSE,
or mad cow disease, in the United Kingdom.
Over one-half million cases of dengue, a viral disease
carried by mosquitoes, have been reported from Latin America
during the past 2 years. During 1996, a tourist to Latin
America returned to Tennessee with yellow fever. There have
been an average of 954 imported cases of malaria each year,
some of which have taken up residence in U.S. mosquito
populations and been transmitted to persons who have never
traveled internationally.
This next chart shows you the distribution of malaria in
the United States 50 years ago. Malaria was eradicated from the
United States in the 1950's and 1960's, but mosquitoes that can
carry malaria and mosquitoes that can also carry dengue and
yellow fever remain. They move north to the great metropolitan
areas in the summer.
Strong surveillance and control of dengue, yellow fever,
and malaria in developing countries where they are occurring
will lead to prevention and containment where they occur.
The next chart shows you cholera, which is on the increase
throughout the world, but as you can see in the green bars,
mostly in Latin America. Over 1.4 million cases of cholera have
been reported from Latin America since 1991. Up to 10 percent
of those who develop cholera died in some areas.
Cholera costs countries in human suffering and death, in
patient care, in lost economic output, and in trade sanctions.
Peru just $770 million in 1991 because of bans of its seafood
exports because cholera had been imported to the country.
Cholera could have posed a real threat to the United States
if unsuspecting authorities had not been alerted by information
from WHO and if WHO through its Baja regional office had not
worked intensively with Latin American countries to stop the
spread.
The next chart reminds us that international travel spreads
infectious diseases. It also spreads microorganisms that have
developed resistance to antibiotics. Strains of the bacteria
that cause common pneumonia resist both old and new
antibiotics. In the early 1990's, during a period of weeks
multiresistant streptococcus pneumoniae, shown on this chart,
spread from Spain throughout the world. Man, like the mosquito,
is a vector of infectious diseases.
Antibiotic resistance spreads rapidly. Death occurs when
antibiotics no longer work effectively and costs for treating
patients increase.
WHO works with developing countries to ensure that
antibiotic resistance is tracked, that prescribing practices
are correct, and that resistant organisms are contained at
their source.
This chart shows you the new WHO network of laboratories
for monitoring antibiotic resistance, which helps countries
develop effective treatment policies. Last year eight
developing countries in Asia and in Africa were brought into
the system, with support from Japan, the United States
Pharmaceutical Research and Manufacturers Association, which
supported activities in Africa, and CDC.
The network must be expanded to other developing countries
in Africa and Latin America, to both human and veterinary
laboratories, and linked electronically to industrialized
country networks.
This chart shows you the WHO network for monitoring
influenza. Laboratories are located throughout the world. Each
year information from this network is provided to the
pharmaceutical industry for development of vaccines which
prevent influenza the following year in our aging populations.
This network must be expanded, especially in southern China,
where new influenza viruses frequently jump the gap between
animals and humans and cause epidemics such as Dr. Bloom
described in 1918, when at least 20 million people were killed
from influenza.
This chart shows the WHO laboratory network for monitoring
and alert of bacterial, viral, and veterinary diseases. These
are strong national laboratories that collaborate with WHO and
use WHO norms to ensure early detection of infectious diseases
in those countries and regions. Information from these
laboratories is used nationally and provided directly to WHO.
The network must be expanded to more developing countries,
especially in Africa and Latin America, and linked
electronically.
prepared statement
Finally, I would just like to go back to the first chart
again, to remind you that infectious diseases occur throughout
the world. They are increasing because of weakened public
health infrastructure and are linked to behavior,
deforestation, climate change, and social upheaval. It is in
the interest of the world community to strengthen WHO's
programs to strengthen national capacity to detect and control
infectious diseases so that we can ensure their containment
where they are occurring. And it is in the interest of the
world community to expand WHO's existing infectious diseases
monitoring networks and electronic information systems.
United States support could make the decisive difference in
how rapidly and how well the job is done.
Thank you very much.
Senator McConnell. Thank you Dr. Heymann.
[The statement follows:]
Prepared Statement of David L. Heymann, M.D.
Mission: To strengthen national and international capacity in the
surveillance and control of communicable (infectious) diseases,
including those that represent new, emerging and re-emerging public
health problems.
the changing picture of infectious diseases: the problem
Few public health concerns today carry as much sense of urgency and
importance as emerging and re-emerging communicable (infectious)
diseases. Many factors contribute to these diseases, including
population growth, migration, urbanization and poverty compounded by
inadequate or deteriorating public health infrastructures for disease
control. Changes in human behaviour and alteration in land use,
agricultural practices, climate and environmental conditions contribute
to increased exposure to and spread of infectious disease agents.
Humans, through world travel and trade unprecedented in history, have
themselves become a principal vector of infectious diseases,
transporting them easily from one country to another within periods
less than 24 hours. Fresh concerns have arisen about the ability of
infectious agents of animal origin to cross the species barrier from
animal to man. Not least, resistance of microorganisms to the drugs
used to combat them and resistance of vectors to pesticides used to
control them have profound implications for our ability to deal
effectively with infectious diseases. Resistance threatens the very
base of infectious disease control. Furthermore, infectious diseases
can have many sources, from natural human or animal occurrences due to
the changing world environment just described to potentially
intentional release of pathogens with the objective of harming human
health or the health of animals and plants on which humans depend.
The urgency and importance for public health of emerging and re-
emerging infectious diseases create an urgent need to monitor the
situation nationally and globally and to respond in a rapid and
effective manner. Effective monitoring and response can only be ensured
by international collaboration and the solidarity of many different
partners ranging from countries and international organizations to non-
governmental organizations, business and industry, government and
private public health and laboratory systems, and universities.
global framework for communicable disease control: the response
The World Health Organization is uniquely capable of putting in
place a truly global framework for communicable disease surveillance
and control activities because of its universal membership of 191
Member States. As the Specialized Agency of the United Nations system
with responsibility for the direction and coordination of international
health work, its Member States have requested WHO to coordinate
intensified efforts to improve global surveillance and control,
especially for the newly emerging, re-emerging and other communicable
diseases.
WHO has identified many partners with the same vision, and its
strategy is to work with these partners within a cooperative global
framework to reshape and strengthen national and international networks
for infectious disease surveillance and control. Laboratory-based
surveillance, international communication networks, national
surveillance systems and a strong national and international public
health infrastructure form the basis of this strategy. Areas of
concentration are:
--Global monitoring and alert systems to bring together laboratories
and disease surveillance systems from all countries to share
information through electronic and printed media;
--Global information systems to ensure that information collected
through global monitoring and alert can be rapidly and widely
disseminated;
--Strong national surveillance and control to detect and decrease or
eliminate infectious diseases; and
--International preparedness to provide strong, coordinated and
engaged response at the international level to provide the
environment necessary for countries to improve their
surveillance and control capacities.
global monitoring and alert systems
Five global monitoring and alert systems are being strengthened by
WHO:
The International Health Regulations (IHR) are the only
international public health legislation which requires mandatory
reporting of infectious diseases. Currently the IHR cover cholera,
plague and yellow fever, though countries often refuse to report these
diseases because of the resulting negative impacts on trade and
tourism. Under the direction of the World Health Assembly, and in order
that the IHR may serve as a working global alert system, WHO is
revising them to make them more effective and comprehensive. Through
electronic links with quarantine officers in the 191 WHO member
countries the system will become proactive, providing immediate reports
of disease and syndrome outbreaks of international importance and
permitting timely provision of recommendations on what measures should
and should not be taken in response.
WHO Collaborating Centers on communicable and zoonotic diseases
already comprise more than 200 institutions worldwide--mainly human and
veterinary microbiological laboratories. These laboratories are centers
of excellence which provide reference services for verifying the
diagnosis of bacterial, viral and zoonotic diseases and/or training or
epidemiological services for WHO Member States. Linking all Centers
electronically will ensure regular exchange of information on
infectious diseases and permit timely identification of problems and
needs so that the necessary training, supplies and/or reagents may be
provided. Information from this system is regularly used to update the
WHO World Wide Web site at . Current efforts are
underway to widen the geographic coverage of the network of WHO
Collaborating Centers to include more developing country laboratories.
Additional military laboratories are also being solicited to join the
WHO networks.
Antimicrobial Resistance Monitoring Networks are an expanding group
of medical and veterinary laboratory centers which perform antibiotic
sensitivity testing on bacteria which cause diseases ranging from
gonorrhea and other sexually transmitted diseases to tuberculosis. The
national data are used for antimicrobial policy formulation and feed
electronically into the WHO regional and global networks for monitoring
of drug resistance and into geographical displays on the World Wide Web
site. Expansion of these networks in developing countries is currently
underway.
WHO Rumour/Disease Outbreak List contains unconfirmed rumours of
communicable and zoonotic disease outbreaks worldwide, which are
received from various sources outside of WHO. This ``rumour'' list is
distributed electronically to key public health policy makers in each
country and to UN agency and NGO collaborators to consider relevant
policy implications prior to actual confirmed reporting of those
diseases by countries. Once confirmation is received, it is published
on the WHO World Wide Web site.
Other Active Global Surveillance Systems which collect information
for action include the influenza network, which collects information
from more than 130 participating laboratories worldwide that is used to
make a decision on influenza vaccine composition for the following
year, and the HIV/AIDS network, which provides information from more
than 90 sentinel sites that is used to monitor the AIDS situation
worldwide. The influenza network is the first of these active systems
to go online with direct electronic data entry by participants, and
with global access via the WHO World Wide Web site for queries to the
database and for the generation of comparative charts and maps. WHO is
in the process of building other global disease databases similar to
this influenza prototype.
To strengthen sites participating in these five systems and to
expand them to those developing countries which are not yet
incorporated WHO and its partners will need to provide intensive
training and some basic laboratory equipment and supplies.
global information access
Developments in electronic communications in recent years have
enhanced national public health surveillance systems and enabled
revolutionary progress in surveillance that crosses national
boundaries. WHO is paving the way in international surveillance by
using communication networks to facilitate rapid collection and
analysis of data using standardized case definitions, transmission of
information for the prevention of communicable diseases, and promotion
of effective public health practice.
WHO provides a focal point for global data and information
exchange. It is working to ensure the timely worldwide dissemination of
information obtained from its monitoring and alert systems and other
information relevant to infectious diseases through the Weekly
Epidemiological Record, WHO publications, the Internet's World Wide
Web, and other media available to the program. WHO is focused above all
on the value of the information being delivered--its quality, accuracy,
relevance and reliability. Electronic communications can make that
information available at any time and place.
The participants of the WHO monitoring and alert systems have been
targeted by WHO as priority sites for electronic linkages. Electronic
linkages under the WHO Global Information Access project are being
developed within the framework of a joint WHO/UNAIDS/World Bank project
which will also link other sites for information exchange. These other
sites include the WHO country representatives, the country/regional
representatives of the UNAIDS program, and the World Bank's projects in
health.
To provide electronic linkage for the developing country sites,
computer software and in some instances hardware, along with
connectivity to the Internet, are required.
strong national surveillance and control
Strong national surveillance systems are at the heart of national
infectious disease control programs. Relevant, accurate and timely
information permits action that decreases or eliminates infectious
diseases, can avert a local or national outbreak, and at the same time
prevent a crisis at the international level. Strong surveillance and
control systems in countries help to identify areas of high risk for
infectious disease, guide immunization and other prevention strategies,
and detect and control the re-emergence of infectious diseases. To
strengthen the national infrastructure in order to recognize, report
and respond to infectious diseases, WHO provides technical guidance
using international consensus policies on surveillance and control
strategies, facilitates activities of governments and non-governmental
organizations to train epidemiologists and public health specialists,
provides minimal support for supplies and equipment, and advocates for
government support of these efforts.
To strengthen national infectious disease surveillance and control,
WHO and its partners will need to supply routine national, regional and
interregional training of trainers and provision of minimal supporting
infrastructure.
international preparedness
International preparedness requires a concerted effort to ensure
that various resources and necessities for communicable disease
surveillance and control are available and adequately operationalized.
This includes ensuring that vaccines, drugs and other supplies
necessary to prevent or treat infectious diseases are available in
sufficient quantity at the international level. It also requires that
expert advice is available when and where needed, and that operational
research continues to identify and operationalize the most efficient
and cost-effective disease surveillance and control strategies. At
times, international preparedness also involves provision of WHO staff
and international partners to work with national health authorities at
the time of epidemics and immediately afterwards in control activities
and in developing plans to prevent future occurrences.
To ensure international preparedness, normative activities such as
support for priority operational research and development of
international consensus strategies for surveillance and control,
laboratory norms and diagnosis must be continued by WHO. In addition,
through continued dialogue and meetings with representatives of the
pharmaceutical and other medical supply industries, issues concerning
availability of drugs, vaccines, and diagnostic tests must be
addressed.
a role for the united states of america
If the world is to respond effectively to emerging and re-emerging
infectious diseases we must do so locally, nationally and
internationally. Whether we are dealing with the complexities of
establishing national surveillance and effective disease control, or
are in the front lines of a response to an outbreak, we need good
laboratory facilities and technicians, people well trained in
epidemiology and disease control, and solid and reliable communication
networks. We must rebuild the infrastructure of public health, and
continue to support it internationally.
Despite gains made in recent decades, many national surveillance
and control programs are still fragile. The world will continue to
battle against infectious diseases for years to come and the costs of
inaction are high. The challenge will be to find the balance of
resources that will preserve and build on what has been accomplished by
WHO and its Member countries and partners. The global framework for
surveillance and control of infectious diseases which WHO is putting in
place will ensure cost-effective and non-duplicative investment in
developing countries in order to rebuild and strengthen capacity to
detect and control infectious diseases. The United States has been one
of WHO's important partners in infectious diseases surveillance and
control, including the global eradication of smallpox in the 1970s and
polio eradication in the 1990s. To tackle the newest challenges in
infectious disease surveillance and control successfully, WHO and the
developing countries will need the United States to continue its
support to form even stronger links in its partnership with WHO. The
report of the National Science and Technology Council Committee on
International Science, Engineering, and Technology (CISET) Working
Group on Emerging and Re-emerging Infectious Diseases has documented
why it is in the vital interest of the United States to contribute to
WHO's activities to strengthen disease detection and containment in
developing countries. Such an investment will further decrease the risk
of the international spread of infectious diseases and antimicrobial
resistance and the associated costs for every nation.
______
Forty-Eighth World Health Assembly--Agenda Item 19--May 12, 1995
communicable diseases prevention and control: new, emerging, and re-
emerging infectious diseases
The Forty-eighth World Health Assembly, having considered the
report of the Director-General on new, emerging, and re-emerging
infectious diseases; \1\
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\1\ Document A48/15.
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Recalling resolutions WHA39.27 on rational use of drugs, WHA44.8
and WHA46.36 on tuberculosis, WHA45.35 on human immunodeficiency virus,
WHA46.31 on dengue prevention and control, WHA46.32 on malaria, and
WHA46.6 on emergency and humanitarian relief;
Aware that with the increasing global population many are forced to
live under conditions of overcrowding, inadequate housing, and poor
hygiene; that more frequent international travel leads to rapid global
exchange of human pathogens; that changes in health technology and food
production, as well as its distribution (including international trade)
and handling, create new opportunities for human pathogens; that human
behavioural changes expose large segments of the global population to
diseases not previously experienced; that expanding areas of human
habitation expose thousands of people to enzootic pathogens previously
unknown as causes of human disease; and that microbes continue to
evolve and adapt to their environment, leading to the appearance of new
pathogens;
Aware also of the continued threat of well-known diseases such as
influenza and meningococcal infections, and of tuberculosis, cholera
and plague, once thought to be conquered, and the growing danger of
diseases transmitted by vectors no longer controlled, such as dengue
haemorrhagic fever and yellow fever;
Concerned at the lack of coordinated global surveillance to
monitor, report and respond to new, emerging, and re-emerging
infectious diseases, by the general absence of the diagnostic
capabilities necessary to identify accurately pathogenic microorganisms
and the insufficient numbers of trained health care professionals to
investigate these infectious diseases;
Alarmed by the increasing frequency of antimicrobial resistance in
bacterial pathogens, which can make some diseases such as tuberculosis
virtually untreatable with currently available antibiotics,
1. URGES Member States:
--(1) to strengthen national and local programmes of active
surveillance for infectious diseases, ensuring that efforts are
directed to early detection of outbreaks and prompt
identification of new, emerging and re-emerging infectious
diseases;
--(2) to improve routine diagnostic capabilities for common microbial
pathogens so that outbreaks due to infectious diseases may be
more easily identified and accurately diagnosed;
--(3) to enhance, and to participate actively in, communications
between national and international services involved in disease
detection, early notification, surveillance, control and
response;
--(4) to encourage routine testing of antimicrobial sensitivity, and
to foster practices for rational prescription, availability and
administration of antimicrobial agents in order to limit the
development of resistance in microbial pathogens;
--(5) to increase the number of staff skilled in both epidemiological
and laboratory investigations of infectious diseases and
promotion in such specialization;
--(6) to foster more applied research in areas such as the
development of sensitive, specific and inexpensive diagnostics,
the setting of standards for basic public health procedures,
and the establishment of fundamental disease prevention
strategies;
--(7) to control outbreaks and promote accurate and timely reporting
of cases at national and international levels;
2. Urges other specialized agencies and organizations of the United
Nations system, bilateral development agencies, nongovernmental
organizations and other groups concerned to increase their cooperation
in the recognition, prevention and control of new, emerging and re-
emerging infectious diseases both through continued support for general
social and health development and through specific support to national
and international programmes to recognize and respond to new, emerging,
and re-emerging infectious diseases;
3. Requests the Director-General:
--(1) to establish, in consultation with Member States, strategies to
improve recognition and response to new, emerging and re-
emerging infectious diseases in a manner sustainable by all
countries and prompt dissemination of relevant information
among all Member States;
--(2) to draw up plans for improved national and international
surveillance of infectious diseases and their causative agents,
including accurate laboratory diagnosis and prompt
dissemination of case definition, surveillance information, and
to coordinate their implementation among interested Member
States, agencies and other groups;
--(3) to increase WHO's capacity, within available resources, for
directing and strengthening applied research for the prevention
and control of these diseases, and to ensure that reference
facilities remain available for safely characterizing new or
unusual pathogens;
--(4) to establish strategies enabling rapid national and
international responses to investigate and to combat infectious
disease outbreaks and epidemics including identifying available
sources of diagnostic, preventive and therapeutic products
meeting relevant international standards. Such strategies
should involve active cooperation and coordination among
pertinent organizational programmes and activities including
those of the Global Programme for Vaccines, the Action
Programme on Essential Drugs, and the Division of Drug
Management and Policy;
--(5) to coordinate WHO's initiative on new, emerging and re-emerging
infectious diseases in cooperation with other specialized
agencies and organizations of the United Nations system,
bilateral development agencies, nongovernmental organizations,
Member States, and other groups concerned;
--(6) to improve programme monitoring and evaluation at national,
regional and global levels;
--(7) to keep the Executive Board and the Health Assembly informed of
progress in the implementation of this resolution.
STATEMENT OF NILS DAULAIRE, M.D., CHIEF HEALTH POLICY
ADVISOR, U.S. AGENCY FOR INTERNATIONAL
DEVELOPMENT
ACCOMPANIED BY DENIS CARROLL, M.D., AID
infectious diseases
Senator McConnell. Would you help me with the pronunciation
of your name?
Dr. Daulaire. Doctor ``DeLare.''
Dr. Heymann. ``DeLare.'' Dr. Daulaire, you are up.
Dr. Daulaire. Thank you. I appreciate the opportunity,
Senator McConnell and Senator Leahy. This is an exciting day
for those of us who have devoted our professional careers to
addressing the issues of infectious diseases.
From my own personal training as a family physician and
subsequently as a public health specialist, I learned that the
best way to ensure good health is not simply to treat the
symptoms of illness, but to systematically address the
underlying causes. Today we call this wellness, and prevention
is at its core.
We all recognize infectious diseases as a very serious
problem, causing 17 million deaths per year and hundreds of
millions of new infections. We can respond by chasing endlessly
after the symptoms of this disease--outbreaks of ebola in
Africa, of plague in Asia, of dengue fever in Latin America,
diphtheria in the former Soviet Union--or we can help the
international community in surveillance and response, as my
colleague Dr. Heymann has just been describing, but focus
ourselves on prevention, on addressing the root causes for the
spread of infectious diseases.
It is my professional judgment that the latter approach is
the best investment we can make in global health and a vital
role for the United States. Therefore, the Agency for
International Development's approach consists of four closely
linked elements. I will describe them briefly.
First, basic prevention through changing conditions that
allow infectious diseases to flourish and spread;
Second, secondary prevention through improving health
systems in developing countries so they are themselves able to
prevent and control infectious diseases within their borders;
Third, targeted disease-specific prevention and control
efforts focused on priority diseases; and
Fourth, response to emergency situations.
That is an intentional ordering.
In terms of basic prevention, the 1992 report of the
Institute of Medicine on emerging infections, which was really
a seminal work for much of what we do here, cited six
underlying factors responsible for the spread of infectious
diseases. Most of these factors cited in the Institute of
Medicine report are addressed not by health interventions, but
by development.
For instance, they talked about crowded megaslums which are
the ideal breeding ground for infectious diseases. We address
these through programs aimed at poverty reduction and at
slowing explosive population growth. They talked about the
undernourished, especially children, who have far lower
resistance to disease and, therefore, serve as incubators, if
you will, and spreaders of infection. We address these through
programs aimed at improved nutrition and food security. They
talked about polluted waters and unchecked breeding sites for
mosquito vectors of disease that are the highways, if you will,
of disease transmission. We address these through our
environmental programs.
The Institute of Medicine also cited the breakdown of
public health measures as a fundamental cause for the spread of
infectious diseases. We all recognize that countries must be
able to provide their own first line of defense, what Dr. Bloom
referred to as self-reliance. Therefore, our focus on the
second part of the four-part strategy I talked about, secondary
prevention, is aimed at rebuilding and strengthening the
fragile health systems of developing countries so they can be
run and managed by their own people.
At AID we focus our efforts on the fundamental building
blocks of health systems--training, supervision systems, drug
supply and logistics, information systems, communications, and
budget and finance. These may seem sometimes arcane, but they
are the basic blocks that will allow all countries to
systematically protect their own people against infectious
diseases threats and, thereby, serve as the first line of
defense for our own country.
Third, far from neglecting targeted disease-specific
prevention and control programs, these have in fact over the
past several years constituted the core of AID's health
programs. In fact, in 1996 approximately $320 million to
activities directly addressing infectious diseases of major
public health importance. I think that is a fact that is not
often recognized, the degree of our investment. And in fact,
this is far greater than any other bilateral donor.
These efforts were principally encompassed within two
groups of activities, child survival and HIV-AIDS. As you are
aware and as has been cited earlier, most of the world's
infectious diseases deaths occur among children. Pneumonia and
diarrhea lead the list, and we have active and effective
programs in these areas.
Malaria kills mostly children. It is estimated about 85
percent of all deaths, as you mentioned yourself, Senator
McConnell, from malaria are among children. And this has been
increasingly incorporated into our child survival programs.
We are also addressing the threat discussed a few moments
ago of antibiotic resistance through these programs,
particularly our pneumonia control programs, where timely and
appropriate treatment with antibiotics is the key to effective
solutions.
I would also mention, Senator McConnell, from your own
experience that starting in the early 1980's AID pioneered the
efforts in the Western Hemisphere to eradicate polio. In fact,
I think we gave the very first grant to Rotary International
that got them into this, which I think was probably the very
best public health investment we have ever made.
Of course, since the 1980's we have also led the world in
programs to address AIDS in the developing world. As we heard,
AIDS is one of the truly emerging disease threats of the world.
Finally, while we recognize--and I mentioned the first
three factors, the first three activities--we recognize that
you do not want to start a health care system by building
emergency rooms, we do recognize that you have to have
emergency response. And we have been actively involved in a
system with response to outbreaks, such as the ebola outbreak
in Zaire, where I believe we were the principal funder of the
immediate response.
Now, that leaves two important issues that were discussed
earlier, malaria and tuberculosis. I have mentioned malaria. We
have invested over the years--and I was quite surprised when I
saw these figures myself--over $1 billion in malaria prevention
and control. In recent years we focused our efforts on malaria
vaccine development, something we call the Africa integrated
malaria initiative, and incorporating malaria treatment into an
integrated case management of childhood illness, which is at
the heart of our child survival program.
Finally, TB. TB remains a major challenge, and we have
focused the resources we have on addressing coinfection with TB
and AIDS because of the enormous risk that this poses. While an
effective approach, technical approach to TB control treatment,
directly observed therapy short [DOTS] course, now exists--
there continue in fact to be major hurdles to be overcome
before this can be widely applied in the developing world, and
I would be happy to address those in followup questions.
Without good program management, supply, and supervision,
WHO has noted that no TB program is better than a poorly
functioning TB program. It encourages the development of
multidrug resistance, and that is what turns a treatable
disease into an untreatable deadly disease.
Is USAID doing enough to address infectious diseases in the
world? Of course we are not. The needs are many times greater
than the resources we have available to them. And yet AID today
devotes a greater proportion of our development assistance
funds than ever before to health, and we do not think it would
be wise to further cut back on our corollary efforts in
agriculture, combating poverty and hunger, basic education,
environmental protection--all issues that I mentioned earlier
as key factors in helping to prevent the spread of infectious
diseases.
prepared statement
Over the past decade, as you are well aware, Senator Leahy,
our development assistance budget has been cut in approximately
50 percent, a 21-percent decline in the past 2 years alone. If
we are going to continue making progress combating infectious
diseases and providing a first line of prevention and defense
for the American people, it is critical in our opinion that the
Congress approve the administration's full budget request for
sustainable development for this coming fiscal year.
Thank you.
[The statement follows:]
Prepared Statement of Nils Daulaire, M.D., M.P.H.
Thank you Mr. Chairman for giving me an opportunity to present to
this Committee information on global needs for the control of
infectious diseases and on what the U.S. Agency for International
Development is doing to address this challenge in the developing world.
key health issues in development
Just two principal health issues in the developing world account
for most of the gap between the health of their citizens and ours. Both
are of direct importance to the development of their countries and to
the continued security of ours. These two issues are the prevention and
control of infectious diseases, and the promotion of reproductive
health through family planning, safe pregnancy and delivery services,
and prevention and control of sexually transmitted infections. Today I
will address infectious diseases. But I would remind you of the
continued importance of reproductive health, with its direct effect on
decreasing the toll of injury and death to women and children, on
allowing the poor--especially poor women--the opportunity to break free
from the cycle of poverty, and on helping societies to escape from the
trap of unsustainable population growth.
The threat posed by infectious diseases to the security and well-
being of the global community is very real. Today we understand that
national borders are irrelevant to microbes, and that in an
interconnected world no disease is more than a day away from our own
shores. We have learned that infectious diseases, and the conditions
that engender them, must be dealt with at their source.
While public attention has focused on acute outbreaks of exotic
viral diseases such as Ebola, age-old bacterial diseases such as
plague, and even new categories of ``prion'' diseases such as Mad Cow
Disease (BSE), the larger infectious threats to human health are more
commonplace and therefore less publicized. Deaths from outbreaks of the
high-visibility diseases that I have mentioned number in the hundreds.
Meanwhile, each year 17 million people die around the world as a
consequence of more routine infectious diseases, principally vaccine
preventable and bacterial diseases. This is where the true threat lies.
USAID has contributed directly to control efforts for the rare and
high-visibility outbreaks, but it is the large-scale threats to public
health which are at the core of our health programs around the world.
Let me stress that this is already a considerable part of USAID's
budget--in fiscal year 1996, we estimate that USAID devoted
approximately $320 million dollars to the direct prevention, control
and treatment of infectious diseases, making us by a considerable
margin the largest bilateral donor for this area.
However, we do not consider a dollar comparison with other donors
as the most appropriate yardstick of U.S efforts, and share the belief
that the world's only superpower has good reason to do more.
usaid's approach to infectious diseases
Let me share with this Committee USAID's view of how infectious
diseases should be addressed, where we have made our principal
investments, and where we have been unable to do as much as we would
like.
The simple view of infectious diseases is that you wait for an
outbreak, then go in with massive resources to stop it. Yet this is
neither good resource management nor good public health--this must be
our last resort, rather than our first line of defense. Prevention of
disease is far more cost-effective than treatment and emergency
response.
In contrast, USAID's approach consists of four elements:
--1. Basic prevention through changing the conditions that allow
infectious diseases to flourish and spread.
--2. Secondary prevention through improving health systems so they
are themselves able to prevent and control infectious diseases.
--3. Targeted prevention and control through specific focused
programs tailored to individual high priority diseases.
--4. Response to emergency situations.
Let me address each in turn.
Basic prevention through changing the conditions that allow infectious
diseases to flourish and spread
The Institute of Medicine's groundbreaking 1992 report on emerging
infectious diseases highlighted six underlying factors responsible for
the spread of infectious diseases. They were:
Human demographics and behavior; Technology and industry; Economic
development and land use; International travel and commerce; Microbial
adaptation and change; and Breakdown of public health measures.
Ever-increasing international travel and commerce are the defining
reality of today's global economy. They are responsible for much of the
economic growth and vitality of virtually all of the world's countries.
Yet they are also the principal conduits for the rapid spread of
infectious diseases. Similarly, developments in technology and industry
can also serve as spurs to the spread of disease. Other agencies are
addressing these areas.
USAID's work makes a vital difference in efforts directed at all of
the other factors.
We work to stem rapid population growth leading to overcrowded
mega-slums, the true breeding grounds that allow diseases to reach a
critical mass, through our efforts at family planning.
We work to improve nutrition, and thereby strengthen resistance to
the spread of diseases, through our efforts in economic development,
agriculture and food security.
We work to provide clean drinking water, reducing the transmission
of deadly pathogens, through our efforts in both urban and rural water
and sanitation programs.
We work to enhance sustainable agricultural practices and natural
resource management, reducing the growth of vectors and disease
organisms, through our environmental programs.
And last but by no means least, we work to improve public health
measures and decrease the chances of dangerous microbial changes
through our support of health systems.
These efforts are the essential aspects of a true long-term
prevention strategy. The fact that they have other equally important
benefits outside the area of infectious diseases makes them even more
valuable as essential elements of our integrated approach to
sustainable development.
Secondary prevention through improving health systems so they are
themselves able to prevent and control infectious diseases
While it is appealing to think of American doctors coming to the
aid of countries around the world, the growing reality of the world is
that countries must provide their own first line of defense. They must
be able to manage, run and support their own health systems if they are
to control infectious diseases. A great deal of USAID's assistance in
health over the past several decades has been directed at key elements
of sustainable health systems. This is not only more cost-effective,
but is an investment which bears long-lasting results.
We work to develop the capacity of host-country nationals to carry
out their own training, supervision, logistics, information systems,
communications, and budgetary management.
We assist in reforming health system policies and financing
mechanisms to encourage collaboration between public and private sector
health providers.
We work to reform national pharmaceutical policies, regulations,
training, and provider and client practices to ensure appropriate (and
minimize inappropriate) use of antimicrobials and other drugs and to
improve the quality of pharmaceuticals that people use.
We assist health systems in applying more effective epidemiologic
surveillance systems for detecting and responding to outbreaks, and
health information systems for monitoring trends of disease over time
and for tracking progress in targeted disease control programs.
We assist in the development of new low-cost preventive,
diagnostic, and treatment technologies, and in the use of information
and communications technologies to enhance health programs and health
education efforts.
Ultimately, we look to leaving successful and workable health
systems in place when USAID assistance has come to an end, as we have
done in countries as diverse as Thailand and Costa Rica. These systems
serve as the true first line of defense against infectious diseases.
Targeted prevention and control through specific focused programs
tailored to individual high priority diseases
USAID's health programs also target specific infectious diseases
which are the principal contributors to death and illness around the
world. Of the 17 million annual infectious disease deaths, the majority
are among children, and the large majority of child deaths are caused
by infections. Therefore, most of our child survival efforts are
specifically targeted against major infectious disease threats. These
efforts have already resulted in 3 million fewer deaths per year
according to UNICEF. They include:
--Diarrheal disease control, including cholera and dysenteries, all
caused by infectious microbes and causing more than 3 million
annual deaths and hundreds of millions of infections.
--Prevention and control of pneumonia, the cause of more than 4
million deaths each year.
--Immunizations against the major vaccine preventable diseases of
childhood, especially measles, tetanus, diphtheria, and polio--
diseases which cause nearly 2 million deaths.
--Prevention, control and treatment of malaria, responsible for over
2 million deaths, more than 90 percent of which are among
children primarily in sub-Saharan Africa.
--Efforts within treatment programs, such as against pneumonia, to
assure appropriate and full courses of antimicrobial treatment
to minimize the likelihood of antibiotic resistance.
--Targeted research in testing new vaccines, technologies and
treatments against the major childhood killers.
In addition to our child survival efforts, the other major targeted
component of our current infectious disease efforts is directed at the
prevention and control of today's most threatening and costly newly
emerged infectious disease: HIV/AIDS. For the past decade, USAID has
played a leading role in developing the tools needed to combat this
epidemic, and in helping countries to apply these tools.
USAID also actively supports applied research on a range of
infectious disease issues. These include:
--Development of more effective, safe, and less expensive vaccines,
and strengthened systems for their delivery.
--Strengthening systems for early case detection; diagnostics and
treatment protocols that are more effective, easy-to-use, and
less expensive; behavioral research and change in key aspects
of disease risk and in how families seek and access appropriate
care.
Response to emergency situations
As I noted earlier, USAID was a major contributor to the emergency
response to the Ebola outbreak in Zaire and played a smaller role in
responding to the plague panic in India; we have played a similar role
over the years in numerous emergencies around the world. However, we
strongly believe that responding to emergencies should be our last
recourse, not our first, and we worry that essential prevention and
control efforts may inadvertently be undermined by a diversion of
resources to whatever has most recently appeared on CNN.
issues relating to malaria and tuberculosis
As I have described, USAID's efforts in addressing infectious
diseases over the span of several decades have been and continue to be
considerable. This is not to argue that they have always been
sufficient. As resources for development assistance have declined, so
has our ability to mount major efforts targeted at specific infectious
diseases.
I would like to highlight two important infectious disease threats
which pose particular challenges to the world community: malaria and
tuberculosis. Malaria kills more than 2 million people each year,
principally children. Tuberculosis is responsible for more than 3
million deaths, the majority of whom are adults in their working years.
Malaria
Over the decades, USAID has devoted substantial resources to
malaria control--more than $1 billion since the 1950's. In recent
years, with the considerable success of these efforts in countries of
Latin America and Asia which were the principal focus of our efforts,
we have moved to a more targeted approach.
Currently, we focus our malaria efforts around our child survival
activities. We recognize that malaria, particularly in Africa, is a
major killer of children. Indeed, approximately a third of all deaths
of children under age five in Africa are related to malaria. To
maximize our investment, we have focused on a few key areas.
--USAID's Malaria Vaccine Development Program (MVDP) is now focused
on finding a vaccine that is effective for children in high
endemic areas. We have partnered closely with the National
Institutes of Health (NIH) and the Walter Reed Institute of
Research (WRAIR) to maintain a substantial U.S. effort in all
of the necessary stages of malaria vaccine development, and
coordinate well with WHO, EU and other donors. This enables us
to translate current knowledge into experimental vaccines which
can be tested in humans. In fiscal year 1996, initial safety
studies of a new USAID initiated experimental malaria vaccine
were conducted in cooperation with other USG Agencies, and a
second experimental vaccine is scheduled for testing this year.
--Last year, USAID established the Africa Integrated Malaria
Initiative (AIMI) to apply the technologies now known for
combating malaria. AIMI promotes a comprehensive ``package'' of
approaches, including the first large scale, sustainable
impregnated mosquito net program in Africa.
--Extensive malaria control activities take place under other USAID
programs. We are the lead bilateral donor and have played an
important technical leadership role in WHO's initiative for the
Integrated Management of Childhood Illness (IMCI), which sets
clear clinical standards for treating malaria and its
complications. Our support for the development of new
technologies has produced two promising diagnostic tests that
health workers in the field can use to rapidly confirm malaria
parasite infection in a cost-effective manner. USAID continues
to train national malaria program managers, in Africa
especially, in information systems and operations research.
More needs to be done, however, in terms of investments in vaccine
development and testing, in efforts directed at controlling the
mosquito vectors of malaria, in developing innovative new approaches in
malaria prevention and in assuring that these approaches are both
practical and sustainable.
Tuberculosis
TB is today reemerging as a leading infectious scourge of mankind
after years of decline. USAID's principal efforts, outside childhood
BCG immunization (which provides modest protection against new TB
infection), have been in support of programs aimed at developing a
rational approach to managing TB among people with HIV infection. Since
the chance of rekindling an active case of TB rises by a factor of ten
as a result of the immunosuppression that comes with HIV, we believe
this is a critical area for action.
While the global need for stronger efforts directed at TB is
obvious, practical solutions in the reality of most developing
countries are less apparent. WHO has recommended that widescale TB
control efforts not be initiated in the absence of confirmable and
strong program management and oversight. The principal risk of a
widespread poorly run program is the high likelihood that multi-drug
resistance will develop, transforming TB into an untreatable deadly
disease.
It has been our experience that health service delivery systems in
developing countries are generally not well prepared to attack TB
systematically and on the scale which is required. TB experts have
recognized that treatment and control of TB is among the most labor-
intensive of health interventions; current protocol calls for direct
health provider contact with each TB patient several times a week
during the entire eight months of short course therapy.
We have found that in most of the developing world where TB is most
prevalent we have had to start more or less at the foundation of
building a health care delivery system before it would be appropriate
or effective to launch an effective program for a nation-wide treatment
of this health problem. In fact, a considerable portion of USAID's
health budget, over $27 million each year, is aimed directly at health
systems development and strengthening. Without this, efforts at TB
control would be futile.
While we do not ``count'' this health systems funding as TB-related
because it has effects on the control of virtually all major public
health problems, our successes in establishing improved public health
systems mean that the more closely targeted TB efforts of others have a
far better chance of succeeding. USAID's involvement has made an
important difference.
It is clear that the resource needs of a truly global effort to
address TB are enormous, in all likelihood dwarfing today's AIDS
control efforts. This is unquestionably the biggest unmet need among
infectious diseases today. Nonetheless, I would argue that in terms of
resource prioritization, our continued emphasis on health systems
development and other important and more easily addressed infectious
diseases is appropriate. The former because TB control efforts will
only work once operational health service delivery systems, well-
managed and well-supplied, are in place. And the latter because we have
proven, cost-effective technologies ready for delivery to save lives.
conclusion
Is USAID doing enough to address infectious diseases around the
world? Of course not--the needs are many times greater than the
resources we have available to apply to them. Yet USAID devotes a
greater proportion of our Development Assistance funds than ever before
to health, and we do not think it would be wise to further cut back our
efforts in agriculture, combating poverty and hunger, basic education,
environmental protection--all, as I have mentioned, key factors in
helping to prevent the spread of infectious diseases. We would urge
this Committee not to cut these critical budgets below the President's
request level.
We continue our efforts to meet this challenge, recognizing the
greater need before us, and working to make the most efficient use of
the resources the Congress has made available to us to improve both
human health and the human condition in the countries of the developing
world. These efforts are broader than USAID or any single agency. In
June 1996, President Clinton released a policy directive that
recognizes emerging infectious diseases as both a domestic and an
international threat. The policy directive calls for improved
international cooperation, training, surveillance, research and public
awareness of these diseases. The President's directive grew out of an
initiative of the National Science and Technology Committee on
International Science, Engineering, and Technology, which created the
report, Infectious Disease--A Global Health Threat. USAID has been a
key participant in the CISET initiative, and USAID's programs of
prevention and cooperation are an integral part of the President's
strategy to protect the health of U.S. citizens and the global
community.
In giving top priority to prevention, and in helping countries to
develop their own capacities to prevent and control infectious
diseases, USAID continues to play an essential role in this effort,
consistent with the requirements of sustainable development and the
long-term interests of the American people.
STATEMENT OF GORDON DOUGLAS, M.D., PRESIDENT, MERCK
VACCINES, MERCK & CO.
Senator Leahy [presiding]. Dr. Douglas.
Dr. Douglas. Senator, it is a pleasure for me to be here
and have an opportunity to address this question, which is very
important to me personally as well as to the company I
represent, which is Merck. I am the president of the Vaccine
Division at Merck & Co., Inc., and I am by background a medical
doctor and a specialist in infectious diseases.
We believe that an increased effort--and I emphasize,
increased--on the part of the United States to understand and
control infectious diseases in developing countries is both
vital to our national interest and it constitutes good public
health policy as well. I think you should recognize it as not
only support through the various agencies that you support, but
with good policies you can enlist the help of the medical
schools and universities in the United States, private
industry, certain scientific and philanthropic foundations as
well.
What I would like to address in my comments is what you can
do to help us, and there are really two things you can do.
First, you can support adequate medical infrastructure in the
poorest countries in the world so that drugs and vaccines can
be used--and I will come back to that in a little bit more
detail--and second, create a business climate so that U.S.
vaccine and drug companies can operate effectively.
I want to do this with a story from our experience with
Mectizan, which has been a very successful program in public
health, because we can learn something about what is possible
and what are the limitations and barriers to being successful.
In the 1970's we developed a drug which we refer to as
Mectizan, and we developed it in a program where we were
looking for remedies for parasitic diseases in large farm
animals, such as horses.
It turned out that this drug was unique and was the most
effective antiparasitic drug that had ever been developed to
that time. And it was noticed that it was effective against a
parasite in horses which closely resembled a parasite which
infected humans and caused a disease which is known as river
blindness, or onchocerciasis. People inside the company and
outside the company persuaded the company to develop it for
that use, that is for river blindness, and we began our first
human trials in Senegal and realized that this disease
afflicted about 20 million people in the poorest countries in
the world, in the remotest regions of the world, and with
either very primitive or absent health care systems.
It became obvious there was no international market for
this drug and that the proper solution was to donate it for use
in river blindness, and so that Merck did this. Our biggest
concern immediately when we got into the issue was the lack of
medical infrastructure in the countries where persons were
affected with river blindness.
Now, you have to remember that this is a very, very simple
regimen. One pill taken once a year is sufficient to cure this
disease. It is a remarkable drug. However, in the countries
which we were dealing with there was no mechanism of assuring
that that could be done. One has to make a diagnosis in a
patient, make sure that that is the right patient to treat. You
have to persuade the patient that the drug is safe. They are
not used to modern medicines. You have to get the drug to the
patient. You have to make sure when patients line up that you
are not treating the same person over and over again because
they do not know the difference. You have to maintain records
therefore. You have to assure treatment of all the patients
with the disease.
These are major issues that have to be solved, and you need
at least a basic medical infrastructure in place for that to
happen. And finally, you have to secure funding for the
distribution of the drug.
We first had to convince people at the tropical research
program at the WHO that this was important. Previously they had
emphasized a program of spraying for black flies. The black
flies transmit this parasite from person to person. And that
program faced all the problems with spraying for mosquitoes for
malaria, for example, and it was doomed to failure. Our drug
worked against the microfilaria, which was the organism which
actually caused the disease.
The solution we came up with was to set up a Mectizan
expert committee, which established criteria and reviewed
applications from countries and regions from people who wanted
to use the drug. And we put in charge of this Bill Fagey, the
former head of the CDC, who is now the executive director of
the Carter Center. With the cooperation of the Carter Center,
the Mectizan expert committee, plus the donation of the drug,
we have had a very, very successful program, and I am pleased
to report that about 20 million people are currently under
treatment and have been getting treatment repeatedly on an
annual basis with this drug.
The point is that having the drug is not enough. Access to
health care or at least an adequate health care infrastructure
is essential for administration of either a vaccine, because
remember this is a vaccine-like drug in that it requires a
single medical intervention once a year in a person, those
appropriate services have to be available. You have to have
full cooperation with the government at all levels in the donor
country.
Senator Leahy. That is once a year as long as the person is
in the area where they are at risk?
Dr. Douglas. Presumably, yes.
And it is essential that this cooperative atmosphere was in
place and the infrastructure was in place and the assurance the
drug could be given.
Now, if you magnify this problem just a little bit and
think about the example about tuberculosis that has just been
described here and will be described some more, remember that
in tuberculosis it is several drugs given several times a week
over an extended period of time. It is a much more difficult
problem.
And if you take it one step further, in the United States
today with the advent of the protease inhibitors--and Merck
developed one of them, Crixivan--we have changed AIDS into a
disease that was life-threatening in all individuals to one
that looks today as if it can be chronically medically managed,
which is an enormous change. It is a very complex regimen. It
is multiple pills, multiple times a day, up to eight pills per
day, many given at points of dietary restriction, and making
the diagnosis, monitoring therapy, monitoring for side effects,
is critical to making this drug successful.
In addition, if it is not done in both tuberculosis and in
AIDS, if inadequate therapy is given, it leads to the emergence
of resistant strains. And it is going to happen in AIDS just as
it has happened in tuberculosis, and that is a threat to people
in the developed world, including the United States.
The goal in HIV therapy is to drive down the virus load
with the persistent giving of multiple drugs, and if you cannot
assure that then drug therapy cannot be given.
Finally, I would like to turn to my last comment, which has
to do with the barriers to American vaccine and pharmaceutical
companies to participating in the lower economic markets in the
world. These are listed in my written--I have listed eight such
barriers, such as inadequate protection of intellectual
property and parallel trade in patent product medicines,
government price controls, et cetera. Those are listed there. I
would be happy to discuss those in more detail during the
question and answer period.
prepared statement
I would just finally like to conclude by saying that if you
can help us in these two areas, that is building up the medical
infrastructure in the poorest countries in the world so that
our drugs and the vaccines which we invent--what a company like
Merck can do best is to discover, develop, produce, and
distribute new and innovative medicines that can help solve
some of these worldwide infectious diseases problems.
Thank you.
[The statement follows:]
Prepared Statement of R. Gordon Douglas
Good morning Mr. Chairman and members of the Committee. My name is
Dr. Gordon Douglas.
I am a medical doctor and a specialist in infectious diseases and
President of Merck Vaccines.
Merck believes that an increased effort on the part of the United
States to understand and control infectious diseases in developing
countries is both vital to our national interest and constitutes good
public health policy.
The discovery of penicillin more than 60 years ago instilled
Americans with a level of confidence in our battle against infectious
diseases that no longer applies. It is all too apparent today that
resistant bacteria, antiviral-resistant viruses, and ``new'' infections
resulting from ecological changes threaten our society. Indeed,
infectious diseases are an increasing cause of death in the United
States.
This nation's renewed war against infectious diseases should not
fall on the shoulders of our government alone. Private industry,
medical schools and other academic institutions, and scientific and
philanthropic foundations can and do have a role to play. Nor should we
view this as a problem exclusive to the U.S. On an international level,
we should build on the solid base of experience provided through the
ongoing work of the World Health Organization (WHO), the World Bank and
United Nations' Children Fund (UNICEF).
barriers to controlling infectious diseases in developing countries
Solutions to controlling infectious diseases include more than just
direct spending by various government agencies. Providing access to
comprehensive health services in developing nations presents a unique
set of challenges including, poor nutrition and sanitation, lack of
trained medical staff, minimal medical facilities (particularly in
rural areas), lack of disease awareness, poor or non-existent medical
recordkeeping capability or capacity. We need a comprehensive public
policy that addresses issues ranging from research initiatives to
health-care delivery infrastructure, and whose implementation depends
on strategic partnership efforts between government and other segments
in society. A recent loan condition adopted by the World Bank is a good
example of such policy. For a nation to secure World Bank resources, it
must demonstrate compliance with the WHO's Expanded Program of
Immunization.
Mr. Chairman, Merck's own involvement with infectious diseases over
the last century illustrates the range of contributions that you should
anticipate from the private sector as a result of our long-range
commitment to better health worldwide.
First is our commitment to--and success in--the discovery and
distribution of vaccines as a preventive weapon against infectious
diseases. Measles, mumps, rubella, hepatitis, Haemophilus influenza
type B, varicella (or chickenpox)--all can be prevented through
immunization with Merck vaccines.
In our pipeline we are developing preventions against rotavirus, a
potentially deadly disease for children in developing nations, and
against otitis media.
Second, with our research in antibiotics, we've made major
contributions in the treatment of infectious diseases. Streptomycin--
which Merck discovered and developed in collaboration with scientists
at Rutgers University in the 1940's--was one of the first important
drugs for the treatment of tuberculosis and is still used in many parts
of the world today.
lessons from the mectizan story
Our experience with the donation of our drug, mectizan, to prevent
onchocerciasis, or river blindness, offers several key lessons for
policies and programs designed to deal with infectious diseases in
developing countries. River blindness is a disease that affects
approximately 20 million people, mostly in sub-Saharan Africa.
During the 1970's, Merck researchers pursued the development of a
new, powerful anti-parasitic compound that proved effective in the
prevention of parasites in horses. While testing the drug on animals,
our researchers noticed that it was effective against a parasite that
resembled the one that causes river blindness.
An infectious disease doctor working in Africa who had seen, first-
hand, the ravages of river blindness, championed further investigation
of the potential human applications for Merck's animal drug.
Human clinical trials were begun in Senegal. But even as we
proceeded with our research , it became very clear that the need for
mectizan was limited to a narrow band of countries and that the
communities in need of the drug are among the very poorest in the
world, in the most remote areas, with only the most primitive of
healthcare services available. Far from anticipating an international
market, Merck recognized that the target population probably could not
afford to pay for the drug at any price and decided to donate the drug.
Our biggest concern with donating mectizan was the lack of a
medical infrastructure and a commitment at every level of government to
get the drug to the people. Absent these, a donation was valueless.
Even though mectizan involves only minimal medical care--just one pill,
once a year--there was no possibility that Merck alone could establish
a delivery and monitoring system that would assure the drug was used
successfully. The product is relatively easy to handle, store and
transport. Yet the significant challenges to delivering it and getting
it administered--establishing a system of identifying potential
patients, persuading them the drug was safe to take, getting the
patients to the drug or the drug to the patients, maintaining records
of the drug's administration and securing a source of funding to cover
distribution--cannot be overstated.
Ironically, one of the major challenges involved convincing experts
at the WHO's Tropical Disease Research program to make distribution of
mectizan a priority. Their focus had been on eradicating the blackflies
that carry the disease and killing the adult worms that cause it,
whereas mectizan was particularly effective against the microfilariae,
or larvae.
The solution was to create an independent committee of experts in
tropical medicine--The Mectizan Expert Committee (MEC)--to establish
criteria for mectizan treatment programs, and to review applications
for free supplies of the medicine. This procedure allowed the orderly
development of guidelines for distribution, the monitoring of any
adverse reactions, and record keeping. The MEC was headed by Dr.
William Foege, executive director of the Carter Center--the institution
created by President Jimmy Carter to promote third-world development.
Having drugs for infectious disease is not enough, as the mectizan
experience demonstrates. Access to adequate health care infrastructure
and appropriate medical services, having the full cooperation,
participation and commitment of all levels of government, including the
activities of international agencies in the areas where river blindness
occurs, has been critical to the successful use of mectizan--a drug
that is relatively easy to distribute and monitor. These challenges
pale in comparison to those we face in successfully tackling TB and
HIV/AIDS.
Despite availability of several effective anti-TB drugs, millions
of people suffer from TB worldwide. Failure to use these therapies
appropriately has led to the widespread emergence of TB strains that
are resistant to existing antibiotics. Furthermore, the HIV/AIDS
pandemic has provided a fertile breeding ground for the spread of
multi-drug resistant TB.
You are probably aware of the remarkable progress that is being
made toward turning HIV infection into a chronic, manageable disease
with the advent of combination drug anti-HIV therapy and the growing
use of a new class of compounds, the HIV protease inhibitors. But these
new drugs are extremely complicated to take.
Merck developed one of these new HIV protease inhibitors, Crixvan,
after a ten-year intensive research effort. Thousands of people with
HIV now are coming forward for treatment, challenging the capacity of
the HIV drug budgets in the public and private sectors in the U.S. and
Europe. The bigger challenge is how such therapies can be used in
developing nations, which bear the burden of over 90 percent of all HIV
infections worldwide.
Clearly, the challenges of HIV/AIDS treatment in these nations are
magnified many times over by the requirements of a complex drug
regimen--multiple doses of multiple drugs that must be taken every day,
most with dietary restrictions. For example, many patients are taking
eight or more different drugs every day. In addition, these patients
must undergo stringent monitoring that requires regular laboratory
tests. This, in turn, requires the clinical laboratory capacity to
perform and evaluate these tests.
A major goal in the use of these new HIV therapies is to drive down
and keep the virus at undetectable levels, but this must be done in a
manner to prevent the emergence of an AIDS virus that is resistant to
treatment with the new therapies. Patients must adhere to a strict
schedule, for instance Crixvan must be taken every eight hours on an
empty stomach or with a low-fat meal. They must have continued,
uninterrupted access to therapy and must have overall comprehensive
AIDS care, that is, access to drugs to treat the opportunistic
infections (such as TB), and access to sophisticated laboratory tests
to monitor the response to therapy. Unfortunately, relatively few
places outside of the OECD countries can offer a critical mass of HIV
care to benefit the patient and protect the public health from the
development of drug-resistant HIV.
barriers to international participation
Merck annually dedicates thousands of research hours and millions
of dollars toward the discovery, development and production of new
vaccines and medicines targeting the prevention and treatment of
infectious diseases. And we welcome the opportunity to work with this
Committee, and others, to formulate public policies that will provide
true benefits.
But we face some significant barriers, Mr. Chairman, barriers which
are shared by other U.S. pharmaceutical and vaccine companies that want
to supply developing countries. These barriers include, but are not
limited to:
--Inadequate protection of intellectual property--specifically, that
countries are failing to meet the Trade Related Intellectual
Property Sections (TRIPS) of the GATT agreement designed to
protect our patent's confidential data and trade secrets, and
even to accept that TRIPS should remain in force.
--Parallel trade in patent-protected medicine also serves to
undermine our property rights--property rights that fuel
research and development for tomorrow's medicines. Parallel
importing arises when different prices are set by governments
among price-controlled markets. A wholesaler purchases drugs in
a market with a low price and then resells the product in
markets with a higher price, pocketing the profits.
--Government price and profit controls that limit research incentives
and the revenues needed to invest in high-risk development
programs.
--Black market sales that often divert products from those who need
them most.
--The lack of quality assurance and the willingness to compromise on
quality to achieve cost savings.
--Inadequate resources for countries to acquire effective therapies
and newer vaccines which necessarily cost more than older
vaccines.
--Epidemiology gaps, by which I mean inadequate data to assess the
occurrence or incidence of an infectious disease in a given
country.
--And finally, as explained more fully above, the lack of health
system infrastructures that can support rigorous treatment
regimens.
An environment enabling U.S. drug and vaccine companies to operate
effectively is needed to ensure delivery of the best quality, most
effective products. For the poorest countries, however, even this is
not enough. These countries need more resources to carry out even
minimal care programs and thus the involvement of agencies such as the
WHO, the World Bank and UNICEF. Clearly vaccines, which may require
only one interaction with a patient, offer much greater hope for these
parts of the world than do complex treatment regimens.
Mr. Chairman, without question the issues surrounding global
infectious disease warrant this Committee's attention. They are serious
issues--they are growing issues--and they represent a clear threat to
the United States. By promoting an environment in which U.S. industry
can operate most effectively overseas, and ensuring adequate funding
for key international agencies, Congress maximizes America's ability to
contain this threat.
I thank you for the opportunity to share these thoughts with you
today and I look forward to your questions.
strengthening infrastructure
Senator Leahy. Believe me, Dr. Douglas, you have a lot of
people in this room on both sides of this dais who would like
to see how best to strengthen that infrastructure. A lot of it
comes down just to one thing, money. That is also why I made
the comment I did earlier, that the nations of the world can
spend hundreds of billions, even trillions, of dollars a year
on defense. A lot of it may well be justified. But we have got
to realize that this is part of our national security and the
amounts of money that we are talking about are so infinitesimal
compared to what we spend on armaments and standing armies,
navies, and air forces.
You have millions, tens of millions, hundreds of millions
of people traveling every day around the world, crossing
borders. That is the guided missiles coming in, the viruses
that travel with them.
And there is the humanitarian aspect. You mentioned river
blindness. I was born blind in one eye and I know how
frustrating that has been to me throughout my life. But I do
not have to work at a job where I need both eyes.
When I hear about river blindness I instinctively shudder.
I think of somebody who has lost both eyes in a place where
they are not a U.S. Senator with a staff and everything
available to them, but somebody who has got to go out and grow
their crops, make their living off their land, sometimes the
most difficult things. And to think that it can be easily
prevented.
And river blindness is not, I would assume, going to affect
us here in the United States. But if we live in the wealthiest
nation history has ever known, 5 percent of the world's
population using 25 percent of the world's resources, then
something ought to tell us we have a moral responsibility, a
very great moral responsibility to help those people.
STATEMENT OF JOHN SBARBARO, M.D., PROFESSOR OF MEDICINE
AND PREVENTIVE MEDICINE, SCHOOL OF
MEDICINE, UNIVERSITY OF COLORADO HEALTH
SCIENCES CENTER
Senator Leahy. Dr. Sbarbaro.
Dr. Sbarbaro. Senator, you just kind of summarized
everything I was going to say and I will make this very
comfortable for you.
Senator Leahy. Go ahead and say it anyway.
Dr. Sbarbaro. It was really insightful.
I was asked to come up with a disease that kind of
exemplified what all my colleagues, the points that they have
made. The obvious answer is tuberculosis. I was thinking how
best to do this, so to make it personal for everybody in this
room I would kind of like you to assume that I have pulmonary
active tuberculosis. And it is a bacteria, and unfortunately it
is one of those bacteria that can stay alive outside the human
body and it is spread basically through the air.
If you all take a deep breath. The group behind me has just
breathed in one bacteria, OK. That is going to grow in their
body over the next 6 to 8 weeks, spread throughout their body,
and then 1 out of 20 sitting in the room right now will
progress on to active pulmonary tuberculosis and share their
disease with somebody else.
Now, the other ones, the 19 out of 20, are going to put
that bacteria into a dormant state, but it is going to stay
alive in their body. And another one, 1 out of 10, is going to
develop the disease in the rest of their life and then they are
going to share that with somebody else.
So if you will all just take a deep breath now. OK, got it?
Senator Leahy. They have been holding their breath ever
since you coughed. I am waiting for them to start passing out
back there.
Dr. Sbarbaro. This is why your wife is noticing the panic
in hospitals, because this is a disease that you cannot protect
yourself from. It is spread through the air. And I just do not
see everybody back here wearing masks. And unfortunately, the
ones that get the disease the most are those age 18 to 40, and
that is the economic base of a country, and when they die,
because when you get the disease prior to chemotherapy, prior
to us developing any drugs, what do you think your chance of
survival, guys, is? Two out of three people died within 5
years.
I mean, you want to talk about an epidemic that scared the
hell out of people. Two out of three people dying within 5
years. And that is why we put them in TB sans. You did not
notice them dying and they were not around.
When chemotherapy came along, drugs, the problem was all
over, and we said: Good deal, that is great. Unfortunately, if
you look at the rest of the world, as Barry Bloom said, you
have 7 to 8 million new cases a year. You have 2 to 3 million
deaths a year. You are going to have 30 in the next decade, 30
million in the next decade.
But what really bothers me is that one out of three people
in the world are walking time bombs like the people just behind
me, harboring live TB bugs. And we have kind of got a huge
stake in this thing because, if you think about all these
folks, where do you spread TB the most? In confined areas. How
do we travel? In airplanes. We have international trade. We
have international students. We have multinational companies.
We have immigrants.
And if you will notice, in our own country a great deal of
our disease comes from folks coming on in, because we have
managed to control this disease, we got rid of it, and so most
of our people--the good news is that most of our people under
the age of 40 have never had contact with TB and are,
therefore, not infected.
The bad news is that most of our people under the age of 40
have never had contact with TB, are not infected, and when
somebody comes in with a drug-resistant organism because we
have treated people poorly in other countries, we are now
susceptible. One of our kid gets the disease, we then spread it
to the rest of our kids, and what you have is a new epidemic in
our country and we are back to the era of sanitariums.
So comes the question, is there a solution that can work?
And yes, there is. WHO has actually come up with a program that
works. As mentioned by the AID groups, it is called DOTS,
directly administered therapy. And what it requires, all it
requires, is that somebody watch the patient take the drugs.
That means the patient has to take all the drugs and cannot
take only one or the other, and if they are not there they do
not take it and, therefore, you do not get drug resistance.
Now, as Dr. Douglas pointed out, what you need is a health
structure. What has been unique is that they have introduced
DOTS into 70 countries already and it does not require changing
the health structure. What you have is primary health care
workers in many of these countries, just village workers, and
when they start giving medications out it actually increases
their status.
What is interesting is that when people start to get well,
other folks come on over to them, and suddenly you have created
a health system. You have enhanced the health system of the
country, not had to go and create a whole new program.
So if you take a look at what has happened in the 70
countries where they have introduced it, you have cure rates in
China, India, Bangladesh, Nepal, and Peru where it has been
implemented of 90 to 95 percent. That is compared to 40 percent
anywhere else. In Russia where they have not done this, you
have gone from 50,000 cases in 1991 to 85,000 new active cases
in 1995. If you are wandering through Russia, do not breathe.
Specifically what can be done? Well, I thought about this a
great deal, and WHO has started to move TB toward the top of
its priority. It has got good wisdom. No. 1, I would actually
encourage, ask the Senate to encourage, WHO to move TB up a
little higher and to use some of their assessed moneys toward
that program.
No. 2, encourage the World Bank to continue what it started
to do, and that is lend money for the specific purpose of
controlling TB. Why? Because it hits the economic base of the
country, the folks age 18 to 40.
No. 3, we really, really need the leadership and strength
of the USAID. They made TB a focus as part of AIDS. I would
love to see them make TB as a focus for TB.
prepared statement
Finally, if we could put some of our own money into WHO's
DOT program and not to go out there and treat everybody, but
what has been very apparent is that WHO uses it as seed money.
They go in, they start a program, it becomes very convincing to
that government, and that country puts their own money into it.
So I do not want to see us--I do not think we can take care of
the entire world, but we can certainly use our money as seed
money to make things happen.
So we have the cure. We can stop the disease, and all we
need is the will, the commitment. You know, it is the old
story: Pay now or pay later.
Thank you, sir.
[The statement follows:]
Prepared Statement of John Sbarbaro, M.D., M.P.H.
My name is John Sbarbaro and I am M.D., M.P.H. affiliated with the
University of Colorado Health Sciences Center and the medical adviser
to the Global TB Education Fund. The witnesses who have come before me
have told a compelling story of the threat infectious diseases pose for
the United States and people around the world. Now I want to tell you
the story of one infectious disease in particular--tuberculosis.
The reality of controlling tuberculosis is that the answer is not
waiting in a lab. We have had a cure for tuberculosis for over forty
years. We're ready to go. Controlling this deadly epidemic rests in the
hands of policymakers such as yourselves.
TB is the leading infectious disease killer of adults worldwide:
One out of every three people in the world today carry live TB bacteria
in their body--walking time bombs--with 8 million new cases of
contagious TB emerging every year. And that number is increasing.
TB kills more people than AIDS and all the other infectious
diseases combined: 3 million deaths per year--hitting especially hard
those between the ages of 18 and 40, which most often means income-
earning parents, giving tuberculosis the morbid distinction of being
the disease that creates more orphans and condemns more children to
poverty than any other; and 30 million deaths will occur in the next
decade from what is right now, in most cases, is still a treatable
disease.
And TB constitutes a clear, present, and continuing danger to U.S.
citizens for the simple reason that it is: spread through the air;
fatal if not properly treated and perhaps worst of all, mistreatment
accelerates the emergence of virtually untreatable drug resistant; and
strains that threaten us all and raises the specter of a return to era
of sanitariums.
The U.S. has a huge stake in this epidemic and must take action
The U.S. overcame its TB epidemic in the mid-fifties by combining
the discovery of effective antibiotics with well directed government TB
control programs. It then packed its bags and checked out of the TB
control effort.
While we were able to close our nationwide collection of
sanitariums, TB-related medical school curricula, funding for TB
research and government programs also disappeared.
The good news is that most of our citizens under the age of 40 have
had no contact with TB and therefore are not infected.
The bad news is that most of our citizens under the age of 40 have
had no contact with TB and therefore are at risk of new infection in
this world of increasing international travel, immigration, trade, and
the growth of multi-national companies. And if we continue to let TB
treatment in the epidemic countries be done poorly, the new TB
infections will be caused by untreatable, drug resistant organisms.
Since we cannot prevent the disease from coming into our country,
its clear that we have to control the epidemic at its source--the
poorer countries of this world.
Practically speaking, it is much more cost effective in the long
run to contribute to controlling TB in another country than to treat
just the citizens and visitors of our country when they fall sick as a
result of a TB infection acquired elsewhere.
Morally speaking--this is a disease that right now we can actually
cure. Treatment is effective and of equal importance, treatment is the
best prevention available today as it stops the spread of the disease.
Treatment not only helps the sick individual but it protects families
and the community.
This is one fight that the U.S. should lead; but to date, as a
nation, we've hardly even been involved.
Today's TB epidemic is not a failure of science, it is as failure of
public policy
Today's TB epidemic is not the result of a failure of science; it
results from a failure of public policy. The disease can be controlled
and yet more people will die this year than in any other year in
history.
Years ago we found the cure for tuberculosis, but we have not
focused on continuing to apply it. It is a lack of political will that
has allowed TB to return and it will take the full force of political
determination to bring this epidemic back into check.
In a perverse and deadly irony, the more we allow tuberculosis to
spread, the more deadly the disease becomes as a result of poor and
partial treatment. It is estimated that there may be as many as 50
million people infected with drug-resistant TB in the world today.
Drug-resistant strains of TB are a man-made phenomena and can be
prevented--they are created through public and medical malpractice
which result in intermittent or ineffective TB treatment.
The U.S. is proof that tuberculosis can be managed. During the
1980's we ignored TB in this country and beginning in 1989 we
experienced mini-TB epidemics in our large cities. We responded by re-
building our TB control programs and our TB rates are again falling at
about 6 percent a year. But we are a well organized, well funded
country.
Can this be done in poor countries? The answer is a resounding yes.
A small but dynamic unit at the World Health Organization--The
Global Tuberculosis Programme--has not only redirected world wide
attention to TB--but has actually come up with a control strategy that
works in poor countries.
Their program is simple, cost effective, doesn't require big
bureaucracy and most importantly, it cures people. They call it DOTS--
``directly administered treatment--short course''--similar to DOT in
this country but with a simple management system which even the poorest
countries can use to prove they are making progress.
The program can work in any health care system--it has been proven
effective everywhere from New York City to China--but requires that the
patient be directly observed whenever taking their TB drugs--thereby
minimizing the potential for premature discontinuation of treatment and
at the same time, leaving no chance for the development of drug
resistant organisms.
This small WHO unit has already convinced 70 of the world's 216
countries to begin using this DOTS TB control strategy--these nations
encompass 23 percent of the world's population, but the DOTS approach
has not yet been spread to all who need it in these countries.
In New York City where the U.S. DOT program has been instituted,
new TB cases have fallen 46 percent and new drug resistant cases have
dropped 82 percent.
In only 4 years, in 9 TB epidemic countries, 1.2 million TB cases
have been entered into the WHO DOTS programs and 85 percent of them
have been cured compared to less then 40 percent cure in areas where
the DOTS program is not being used.
WHO has documented a 95 percent cure rate in China where over
90,000 new infectious cases were treated with DOTS in 1995. Over
150,000 infectious cases were under DOTS treatment in 1996 and will
show similarly high cure rates.
Similar cure rates have been documented in Bangladesh, Nepal, Peru
and parts of Africa, and small areas in Indonesia and India, where DOTS
programs are starting.
On the other hand in Russia where the DOTS program has not been
implemented, the number of TB cases has grown from 50,000 in 1991 to
85,000 in 1995. I would predict that drug resistance rates in that
country are also soaring as they are in Latvia and Lithuania, where the
prevalence of multi-drug resistant TB is already above a terrifying 10
percent level.
Overall, sadly, and frankly inexcusably, as a result of too little
being done too late by those with the money and power to act, only 10
percent of the world's population suffering from active tuberculosis is
being treated with DOTS right now. While this is an enormous advance
from just a few years ago, it is grossly inadequate and definitely not
in U.S. national interests.
The U.S. can make a difference
The U.S. can make a difference. And not just by spending more money
in the U.S. At this point in time, the U.S. is basically in control of
its TB problem. It must have the same impact throughout the world or
the TB problem will return to our shores.
We should insist that the World Health Organization leadership
place TB control and the use of the DOTS strategy near the top of its
priority list and insist that it support this priority with more of its
own WHO funds.
We should urge multi-lateral institutions like the World Bank to
devote at least 5 percent of their lending towards controlling
infectious diseases--with an appropriate emphasis on tuberculosis--and
this commitment should be at least for the next two decades. This is
not an esoteric illness, it has real economic implications. Remember,
TB hits the working age group--the economic base of a developing
country.
We need the strength and leadership of the USAID to really focus on
TB itself--not just as a complication of HIV/AIDS. USAID should be in
front of good global tuberculosis control, not behind. This is
something America can do that is good for the world and good for
America. Not many foreign assistance programs can draw such a
connection.
And, we should commit some of our own money to advance a unified
worldwide TB control program by financially supporting WHO's Global TB
Programme (which functions in the same way as our CDC TB Elimination
Division) and by supporting the division's NGO partners--for example:
the International Union Against TB.
Simply put: We need to expand the worldwide implementation of the
DOTS strategy.
Finally: As has been noted by previous speakers, we are going to
need funding for additional research--there's no doubt about that. But
right now we already have the tools to save lives today. If we properly
treat someone with TB today, they will begin getting better tomorrow
and we will have prevented the disease from spreading or worse yet,
mutating into a potentially incurable drug-resistant form.
What we really need is the will, the commitment, and the leadership
to get the job done.
If we don't, we'll see a continuation of what presently exists--too
little, too late, and too timid--and the result is an epidemic that
threatens us all.
seed money
Senator Leahy. Using it as seed money, how do you choose
where to plant the seed?
Dr. Sbarbaro. The country has got to be interested. You
have got to convince it that, No. 1, it is a problem. And
that--you know, as soon as a government realizes that even the
elite are not protected--you know, I have got somebody who
helps me in my home. Is that person coughing? Well then, your
kids and you are at risk. It suddenly becomes very apparent
that this is a disease that knows no class, it is not
economically based, although it is spread in poorer areas, as
Dr. Bloom pointed out. But those poor areas mingle with
everybody.
They have been able to convince 70 countries to start. Once
you start that, the economic advantage both to the country and
the reduction in disease burden helps.
All these folks are going to bring this disease into our
country. We have a real--we really have got something at stake
here. To help them is to also help us, and I think that has
been made by all four of my colleagues.
Senator Leahy. So much of this is interrelated. It is
caught up in everything from civil wars and the mass movement
of refugees that we see in Rwanda, to a chaotic society like
Nigeria today.
Earlier this morning I was speaking to a group about
antipersonnel landmines, and the effort that I have been
involved in and so many others have been involved in around the
world, to ban antipersonnel landmines.
I recall where we used the Leahy War Victims Fund to
provide prosthetics for victims of landmines in Uganda. I was
there with my wife, Marcelle, Tim Rieser, and others. We were
looking at people who had been injured by landmines, and my
wife was helping one of the medical people with a young child,
to bathe him and dress him. He was horribly crippled.
We asked the translator, what had happened? It was from
polio. She was saying to me afterward: Do we not--for God's
sakes, polio is so easy to get rid of. Do we not have a
program? Do we not give them money? Do we not help? It turned
out we did. But the people who had to administer the vaccine
could not get to the village because of the landmines.
So this little boy never stepped on a landmine, but he was
crippled as much as if he had.
The reason I asked the question of how you pick the seed or
where do you plant the seed, is there enough stability, so that
WHO or AID or anybody else can operate there?
We have this problem even here at home. My kids are growing
up, just out of law school and struggling to make ends meet,
like everybody else. But you just assume of course--the kid is
coming along, the pediatrician says you come in at such and
such a time and you get these shots, and you come in, you just
do it.
But now we are finding even in our country, where there are
programs and everything else, people are not doing it.
Dr. Sbarbaro. To give you some hope, Senator, I have to
point out we did this in New York, and if you can do it in New
York you can do it anywhere. And we actually cut the rates down
by 45 percent.
Senator Leahy. Well, let us say that--we do not have all
the money in the world, but let us say--well, actually we do
have all the money in the world. We just do not want to spend
it. [Laughter.]
But let us say we had an additional $50 million a year for
5 years to devote to this problem. What would you do? I ask
anybody in the panel who wants to answer. Do you try to wipe
out one or two of the priority diseases, or do you build the
infrastructure to be able to identify and contain diseases
before they become epidemics? How would you use the money? Dr.
Bloom?
Mr. Bloom. I do not see those as alternatives. I think you
have to do both, and you have to ask where you get the most
return. I think that one of the places you get returns from is
knowledge, public goods. There are programs at WHO that deal
with infectious diseases that I think do an extraordinary job
of not only acquiring knowledge and transmitting it to
developing countries, as you heard in the TB program, but they
actually show that they can work.
An example is when it was proposed that we vaccinate all
the world's children, all the wise people figured that could
not be done: too expensive; how are we ever going to get it out
there? Well, in 1992--I can tell you what the 1992 figures were
very well. Some 80 percent of the kids in the world got
vaccines, and 36 percent in New York. So we can get vaccines
out there and, as you know, to wipe it out in the hemisphere.
That happened because it was done in a single country and
shown to work. So if it is done and done well, it has an
impact, creates a competition, and other countries will want
it.
WHO extra-budgetary programs, the tropical disease research
program, for example, on malaria; the United Nations AIDS
Program on setting up areas to test vaccines in AIDS that will
be as important to us as it is to the people in those
countries; the emerging infectious program of David Heymann to
link surveillance centers around the world. These will provide
vast knowledges, amounts of knowledge that countries can use,
and then to target those that are willing to use them through
AID to actually get it done.
Thank you.
Senator Leahy. If I could just follow up on that, Dr. Bloom
and maybe with Dr. Heymann. You have got an organization, WHO,
and one of the ones you hear, is that you have 200 bosses--the
member countries and Dr. Bloom from country A has this
priority, Dr. Daulaire from country B has another priority, and
on and on.
WHO tries to do everything because everybody wants you to
do everything. But don't you have to do some kind of a triage?
I mean, if there are six or seven diseases that cause 70
percent of the deaths, is it not better to go after those six
or seven diseases, even if it means others are left out?
Of course, if you are part of the ones with that disease
No. 9 or 10 that has only 5 percent, but you are in that 5
percent, that is the one most important to you. How do you do
this?
Dr. Heymann. Thank you for that question. I think first of
all, I think the number of countries that belong to WHO,
essentially all countries in the world, are a reinforcing
factor for such underlying activities as we are trying to
develop now, which is stronger surveillance and control within
countries.
What I have shown you in my briefing paper is that WHO is
setting up a framework which meets the needs of countries in
the north which want to contribute to the south. It sets up a
framework where they can work bilaterally, and it also
strengthens underlying surveillance and control activities.
Each country does have different priorities. Each country
must address these priorities. But they can address them with
certain generic things, as Dr. Daulaire said also,
strengthening those surveillance systems and detection systems
and control systems, so that the health care system is
available and able to do what is necessary to fight the local
priority diseases.
It is true that WHO at headquarters has a diverse program.
WHO is refocusing. I am pleased to tell you that 12 percent of
budget in the next biennium will be reallocated to what our
executive board has said are priority programs, which includes
infectious diseases.
We have tried to estimate a budget for the next 2 years of
what WHO would need to set up this surveillance network, so
that we would have a framework which would include the global
monitoring and alert systems, the laboratories in countries,
global information access electronically, national and regional
strength in surveillance and control, that underlying
preparedness to face, detect and face epidemic diseases and
routine infectious diseases such as AIDS, diarrhea, and
malaria, and finally an international preparedness that will
make sure there are enough vaccines, that will make sure there
are enough drugs which are necessary to take care of these
programs.
We have estimated $26 million in 2 years to set up the
framework. That framework then permits USAID, the European
Union, United States Task Force, the European-Japan Common
Agenda on Emerging Diseases, to build within that framework
bilaterally to strengthen global surveillance and national
surveillance and control.
Thank you.
Senator Leahy. Dr. Daulaire, what would you do with that
$50 million?
Dr. Daulaire. Well, let me answer your question in two
parts, Senator Leahy. First, the issue that we have been faced
with repeatedly over the past 4 years has been that the
Congress has come to us with money for specific reasons--polio
eradication is one example--but it has been one of these shell
game procedures in which we are given the money, but that money
then is removed from the rest of our budget. So my first plea
would be, if we were to get $50 million----
Senator Leahy. Make it a real $50 million.
Dr. Daulaire. Make it real, that is right. Do not just put
it underneath everything else.
Second, what we have also found is that the more we get
micromanaged--you have to spend it on--for instance, going back
to the polio initiative, the first legislation for that stated
that we could only use that money to purchase polio vaccine.
With all due respect to my colleague on the left who produces
vaccines, this is not where we had a comparative advantage, nor
was it where the greatest need was in terms of the polio
eradication effort worldwide. And we discussed it with the
Congress and were able to get that lifted.
I think the key issue needs to be to focus on where we are
going to have the major impact, broadly speaking, on public
health. So the third part of my response would be, if you were
to give me $50,000 today personally and ask me to invest it, I
would not put it all in Microsoft. Maybe I should, but I would
not.
Senator Leahy. No; you would have done that 15 years ago.
Dr. Daulaire. That is right.
But what I would do and what we would do at AID is to put
it into a portfolio. We would be looking for some things with
short-term quick returns--eradication efforts in specifically
targeted diseases where we could get a quick bang for the buck.
We would be putting some things into longer term payoffs, such
as research, moving the technology forward. And we would be
putting most of it into the application of existing technology
in disease control programs.
I think that TB, as Dr. Sbarbaro has said, is really the
key unresolved issue in public health in the world today. We
could certainly do more in that area. We would have to do it
through the strengthening of health systems and integrating it
into the systems that are already there.
Senator Leahy. Dr. Douglas, would you like to add to this?
Mr. Bloom. Yes; I would. I think you have heard that you
could do a lot in terms of building up infrastructure with a
fairly small amount of money, and I think that I support what
Dr. Daulaire and others have said, is that you really should
not try and micromanage this, but rather let the experts make
sure that the money is going to the most important diseases and
ways of handling the most important diseases, whether it is--it
may well not be purchase of medication. It may be setting up a
structure in which that can be used, which was my Mectizan
story.
Let me give you another example of something that is
needed, and that is epidemiology. That is the study of a
disease in a population, whether or not it exists. We have
developed, as have several other companies, a vaccine which is
called a HIB, vaccine, which is now one of the routine vaccines
administered to children in the United States and Western
Europe. It has virtually eliminated childhood meningitis in
this country in the 1990's. It is one of the medical miracles
of the 1990's and you never hear about it. It is an amazing
achievement.
It is not available in most of the poorer countries of the
world. A study was recently done in Gambia which showed that
not only was meningitis eliminated from these kids, but a
significant segment of pneumonia. And if you remember Dr.
Bloom's pie chart, that acute respiratory disease in childhood
is one of the three or four largest killers in the world.
We need to understand whether that problem exists
worldwide. If it does, you have today a vaccine infrastructure
worldwide that immunizes 80 percent of the world's kids with
all the appropriate vaccines. HIB could be added to that for a
very low cost to the world, or to the United States or
something. We are not talking about megadollars to do that, and
that would be a wonderful achievement if the epidemiological
base for going forward was there. And the epidemiology could be
done for a very small amount of money, and it is not being done
today.
Dr. Sbarbaro. Senator, I noticed you looked at me, but one
aspect of a wise person is to know when he has got real
expertise on his right. I am not going to second-guess Daulaire
and Heymann, no way.
If you could nooge them to take care of TB a little bit
more, I would sure like their expertise, though.
Senator Leahy. I think of some of the things that happen in
this country. You go and get your sprained ankle taken care of
in a hospital and you end up with some kind of an infection,
staph infection or something else, resistant to penicillin. I
see more and more resistant infections, and I also see that we
are using more and more antibiotics for a whole lot of things.
They pass them out like chewing gum in some places. We add them
to animal feed all over the world.
Are we creating our own monster?
Dr. Sbarbaro. Yes.
Dr. Douglas. Of course. Yes; we are. I will take at least a
first crack at that. There is no question that the widespread
use and overuse and abuse of antibiotics is one of the reasons
for the emergence or the rapid emergence of resistant strains.
It has happened with viruses, it has happened with bacteria. It
is going to happen with the AIDS drugs. It is a natural
phenomenon.
There are certain settings in which it occurs. If you
inadequately treat, underdose, patients, give small doses of
drugs or skip doses, that is a situation in which emergence of
resistance will occur.
What is the ultimate solution? One of the ultimate
solutions that everybody always jumps at is we should invent
more drugs. It is harder and harder to invent new antibiotics
and it is a very expensive process.
Another solution is to develop vaccines so that you do not
even get these infections in the first place. The example of
streptococcus pneumonia, for example, is a wonderful one. It
was mentioned earlier by one of our speakers, the major cause
of pneumonia. There is a vaccine for older persons which will
prevent pneumococcal infection and in development for younger
persons, again, a vaccine that could be used worldwide will
prevent the occurrence of that infection, and then you do not
have to worry about the emergence of antibiotic-resistant
strains.
Dr. Daulaire. Let me add to that, Senator. Mistreatment and
inadequate treatment are at the root of the widespread
development of antibiotic resistance. Throughout the developing
world today you can go to almost any street stall pharmacy and
purchase almost any pharmaceutical product, certainly almost
any antibiotic. The common way in which illnesses are treated,
and often it is the common cold, is with a day or two of an
antibiotic, because it is readily accessible in that context
and it is reasonably inexpensive. People go and they use their
own money for it.
Often it is promoted and enhanced by poorly trained
physicians in these countries. I have actually seen this in our
own country, so it is not restricted to the developing world,
where people make hip-pocket decisions on treatment. And again,
a poor patient who has to shell out money for a drug, they may
be able to buy a few days supply, but very often what they will
do is they will save--once they are starting to feel a little
bit better, and this is particularly true with TB, they will
save their medicine for another time.
This is an enormous contributor. And what we have found in
our programs--I cut my teeth in a field trial on treatment of
childhood pneumonia. What we found is that it took real
assiduous followup with patients to make sure that they took
their entire course of antibiotics. That is how you both treat
the disease effectively and prevent the development of
antibiotic resistance among the organisms.
Senator Leahy. Yes?
Dr. Heymann. Thank you, Senator.
I would just like to add that it is not only a problem in
developing countries, misuse of antibiotics; in countries like
the United States and Canada as well. Canada just published an
article in ``The Lancet,'' a well known medical journal,
where--I cannot quote the exact figure, but between 30 and 40
percent of antibiotics were used when they should not have been
used. It happens in this country as well for influenza, because
a patient demands an antibiotic when he sees or she sees a
physician. Physicians and others must educate the public that
antibiotics are not always indicated.
I would like to just address also the issue of antibiotic
resistance in animals, because this is an issue which must be
studied more. What we do know is that antibiotics are used
increasingly in animal husbandry. And if you look at a graph,
for example, of salmonella in the Netherlands, an organism
which causes typhoid, you can see it is a normal inhabitant in
certain animals, and you can see that resistance to antibiotics
is increasing in those animals.
If you look at resistance of the same organisms in the
human population, there is a parallel increase in resistance.
Now, these are not necessarily linked, but they are
circumstantial evidence that there is a parallel increase in
resistance in both animals and in humans which are infected
with organisms which also infect animals. Now, bacteria have a
means of transferring resistance from one to another outside a
human body. So this may be occurring in the environment or it
may be occurring within animals and then transferred to humans.
But there is a parallel increase in the Netherlands which
shows clearly the same trend in human and animal infections of
one organism.
Senator Leahy. What about, you talk about a global system
for surveillance and control. If that had been in place, 15 or
20 years ago, would we have identified an AIDS epidemic, No. 1?
No. 2, is it conceivable that it could have been isolated?
Dr. Heymann. I would like to take a crack at that, Senator.
In the first ebola outbreak in 1976 in Zaire, specimens were
collected from villages around the outbreak site, many, many
blood specimens. These were stored at CDC. Some 10 years later
when there was a test for HIV and when HIV had been recognized,
because in 1976 it was not yet recognized, but 10 years later
those bloods were screened for HIV, and already they had a
level of HIV of 1 percent of HIV in 1976.
AIDS was a rural disease in Africa which was not spreading.
We know it did not spread greatly because 10 years later in
1986 when those bloods were screened that had been collected in
1976, bloods were also collected again from those same
villages. HIV remained 1 percent.
What happened to HIV was, it was not recognized in rural
areas of Zaire or other places where it was occurring. It got
into major metropolitan areas, where behavior encouraged an
amplification of that disease, and the disease amplified and
spread worldwide.
If there had been systems which could have detected
something unusual even in 1 percent of the population in 1976,
we may have been able to understand that there was a disease
which was present, which maybe was present, many, many years
before that and which could be contained. So I think the answer
is strong surveillance systems in countries can help to
identify diseases early and permit a response and possibly
containment where they are occurring.
Dr. Daulaire. Let me add, Senator, there is no question but
that early identification would have had a considerable impact
on the dynamics of the HIV-AIDS pandemic. I also very much
doubt that we could have contained it at that point. By the
time that HIV began its incursions into Asia, we knew about the
disease very well. We had good tracking mechanisms, and that
has certainly helped to slow its spread, although Asia is today
the site of the largest number of new infections of HIV per
year in the world, surpassing Africa.
What we could have done by an earlier detection and by a
better surveillance mechanism was to change the dynamics of
this epidemic, slow it and give us more time to get it under
control rather than letting it get out of control, as it has.
Senator Leahy. Let us take a situation closer to home. In
September 1995 the New York Times stated, ``There is a new
virus attacking thousands of people less than 10 miles from our
borders. Yet we greet this nearby epidemic with an eery
silence.'' They were talking about dengue.
Then look at some other numbers I have here: Nicaragua,
35,000 cases of malaria, 17,000 cases of dengue, 2,000 cases of
dengue haemorrhagic fever.
I look at cities like New Orleans or Houston, where you
could replicate some of the situation that might raise that.
Now, does this strike us as something where AID should put up
our first line of defense, or who does? Or are we? Maybe we
are?
Dr. Daulaire. We are in fact involved in this. I should
mention, Senator Leahy, that I personally had dengue fever, if
not the dengue haemorrhagic fever. It is an unpleasant thing to
have, but I had a mild case.
Senator Leahy. Somebody described it to me, they call it
the broken bone.
Dr. Daulaire. Break-bone fever.
Senator Leahy. Break-bone fever.
Dr. Daulaire. Mine did not break.
Senator Leahy. But it felt like it did?
Dr. Daulaire. Oh, yes.
First of all, we have to recognize, AID actually is
spending about $1 million a year strengthening programs in
Central and South America dealing with dengue fever. So yes, we
do have a response.
On the other hand, is this one of the leading public health
challenges in the world today? We think it probably is not.
There are about 200 people--I mentioned earlier 17 million
people die of infectious diseases around the world. About 200
die of dengue haemorrhagic fever in Latin America each year.
Now, that does not minimize the problem. There are hundreds
of thousands who get infected annually and it has the potential
to become a real problem for us as well. So our approach is to
deal with environmental issues, because it is a mosquito-vector
disease, and also to deal again with the health systems,
because with proper case management the case fatality, the
number of deaths for every 100 cases of dengue haemorrhagic
fever, is less than 1 percent. So it is something that can be
dealt with at the health systems level without this enormous
case fatality.
Senator Leahy. Well, let us take one that many people are
more apt to get, and that is malaria. There are one-quarter of
a billion people contracting it each year and a couple million
people dying of malaria. I remember on a trip to Africa taking
some malaria prevention medicine which had such terrible side
effects that one of our pilots became suicidal, not the sort of
thing you want to have happen to the pilot of your airplane.
You want pilots to have a good attitude toward life and a
strong sense of self-preservation, especially as they are
landing at about 200 miles an hour.
My wife became sick and we realized it was the medication.
She stopped the medication and was fine. I see Dr. Denis
Carroll here, who works with malaria at AID.
I have seen these mosquito nets. They are insecticide-
impregnated mosquito nets. I am told they cost about $5, which
for those of us in this room is nothing, but in many parts of
the world you want to use it the $5 is an enormous amount of
money. Do we have a program to get these things to people who
need them? Second, if we start making enough of them does the
price go down? Third, are we ever going to see a vaccine for
malaria? That's three questions.
I bet you are glad you are here.
Dr. Carroll. Thank you, Senator Leahy.
Actually, I am glad I am here. And it is worth noting that
particular bednet you have there comes from a program that AID
has carried out in central African republic. What is worth
noting about the bednet is that it is a technology which, with
impregnation using insecticides for treating that netting
material, the World Health Organization over the last several
years has shown dramatic impact on the health and well-being of
children in sub-Saharan Africa.
In large portions of the areas that have been tested,
survival rates of up to 30- to 40-percent reduction in child
mortality by appropriate use of the bednet. You however point
out one of the real problems associated with the bednet, and
that is the cost, $5. And that is $5 for a single net, and we
do know from the studies that we have done and from our field
experience that you are likely to have to deal with three or
more nets per household. So you are talking about a much larger
bite out of the personal income of families. And on top of
that, you are talking about a recurring cost of about $1 to $2
a year for retreating that net with the insecticide.
So it is not free and it is not certainly an easy economic
challenge to the populations. We do not have the answer right
now as to how you deal with that. We are concerned about the
high cost.
We are right now supporting and beginning to undertake the
first large-scale voluntary use programs in Africa in two
African countries right now, and we are hoping to, through
these experiences, better understand how to address the issue
of affordability, among other possible problems associated with
it.
Senator Leahy. This is an area where private industry could
come in and help, too.
Dr. Carroll. I can note that in these areas where we are
working we have the benefit of a partnership with Bayer, which
is, in much the way that Merck has made Mectizan available for
purposes of the onchocerciasis control activities in Africa,
Bayer is joining with us in making available the insecticides
that we need in order to move forward with these trials right
here.
So that we are exploring, we are testing how we can work
with the private sector and how we can create appropriate
private-public sector partnerships to address the issues of
affordability.
Senator Leahy. Unfortunately, I have to leave for a meeting
with the President at the White House, who is then going to be
in about 30 minutes up here on the Hill.
I have many more questions. I look at some of the facts
that staff prepared for me in getting ready for this. They
talked about after the collapse of the Soviet Union the public
health system fell apart. I guess by 1995 there were 25,000
cases of diphtheria, 5,000 people died.
Diphtheria is something we have had a vaccine for, I do not
know, certainly all my lifetime, I guess most of this century.
So it disappears, and then you let down your guard, and, boom,
it is right back there again.
additional committee questions
Could I suggest this to each of you. You could probably
think of more questions than I could. If there are further
items that you think we should have covered but did not here,
further thoughts you have--all your statements will be part of
the record--send them to me, and we will include them in the
record.
We do not think of these things affecting us, but I hope
that everybody who has listened today realizes there is nobody
in this room who is immune from the issues we are talking
about. We may be immune from river blindness as Americans, but
we are not immune from many other diseases. I said before that
we have a moral responsibility on river blindness.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Campbell
tuberculosis
Question. Rates of Tuberculosis infection are extremely high among
the poor in developing countries, but the United States also has its
share of cases. Wherever people are impoverished, lacking proper
medical care and living in overcrowded conditions, the disease may be
found.
Frighteningly, the strains of TB found today are becoming
increasingly drug-resistant. Medical costs to cure tuberculosis
skyrocket once resistant strains emerge. The cost of treating a TB
patient in the United States can jump from several thousand dollars for
outpatient treatment to $250,000 to treat multi-drug resistant TB.
(A) In what ways can we seek to ensure that U.S. foreign aid
funding used to fight tuberculosis is having the most on-the-ground
impact in the countries with high incidence of TB?
Answer. USAID has sought to ensure that the funds available for
tuberculosis programs are used most effectively. The majority of funds
($7.5 million) have been allocated to purchase infant BCG vaccine
(Bacillus-Calmette-Guerin), which minimizes the complications and
shortens the course of pediatric tuberculosis. USAID has also supported
operations research and evaluations of national TB control programs to
determine the most cost-effective methods to accurately diagnose and
treat patients. This research has helped to identify a broad range of
health providers (in addition to hospital-based physicians) who can
care for patients in remote and underserved areas. USAID is also
developing a CD-ROM-based interactive computer program to optimize TB
case management. By increasing the number of providers capable of
providing care to tuberculosis patients, standardizing and streamlining
optimal training of providers, and ensuring the availability of
services to those in need, USAID hopes to improve and shorten the
course of treatment of TB patients, and maximize resources so that more
patients can be appropriately treated.
Additionally, USAID works to maximize the on-the-ground impact of
efforts to fight TB through our health systems development and
strengthening programs, which represent about 9 percent of our health
care budget. While we do not ``count'' this funding as TB-related since
it impacts the control of virtually all major public health problems,
our efforts in system strengthening mean that the more closely targeted
TB efforts have a chance of succeeding where they otherwise would not.
immunizations
Question. Immunizations are a simple and cost effective way to save
children's lives--it costs as little as $17 to immunize a child for
life against measles and five other deadly diseases.
Reports indicate that the United States could save millions of
dollars in treatment and prevention costs if these diseases were
completely eradicated around the world. For example, the total amount
of external aid needed for a five year period to eradicate polio is
approximately $130 million per year. Reports indicate the U.S. alone
could save twice that much a year once the virus is eliminated.
(A) Can you talk a little about the progress that has been made in
terms of vaccinating against easily preventable diseases, and how much
more still needs to be done?
Answer. Globally, today, immunization rates approach 80 percent,
compared with only 44 percent in 1985 when USAID launched its Child
Survival Program. In many USAID-assisted countries, immunization rates
are even higher. A 1995 survey in Honduras, for example, showed that 94
percent of children less than one year old were vaccinated for all
immunopreventable diseases (measles, polio, DPT, and BCG) by 1993.
Worldwide, an estimated three million lives of children are saved
annually as a result of immunization against childhood diseases, and
one half million cases of polio are avoided.
In 1994, polio was officially declared eradicated in the Western
Hemisphere. USAID, the largest external donor to this effort,
concentrated particularly in the poorest countries such as Bolivia and
Haiti where vaccination rates lagged seriously behind those across the
rest of the continent. Worldwide, as coverage rates have doubled over
the past decade, polio cases have been cut by two-thirds. USAID's new
Polio Eradication Initiative is now focusing on sub-Saharan African and
South Asia.
Since more than 100 million infants a year need immunizing, much
remains to be done, particularly in Africa where immunization coverage
averages under 50 percent. Although immunizations are an effective and
efficient tool for saving children's lives, access to health care is
still difficult for rural populations in many of the least developed
countries. For example, delivering immunizations on a sustainable basis
is problematic in the middle of the new Democratic Republic of the
Congo. USAID is working with both public and private sector systems to
strengthen immunization systems and their outreach in such situations.
Certification of a ``polio free'' developing world (notably Africa) is
especially challenging. With that in mind, we need to be prudent in
anticipating the ``eradication'' or ``elimination'' of other diseases,
such as measles.
(B) How can we best ensure that our investment results in programs
which reach poor people in their communities and programs with the
highest possible impact? What are your views on current ways to measure
the impact of these programs on-the-ground to be sure we are investing
wisely and effectively?
Answer. USAID has focused its efforts on reaching the poor in
developing countries. We work with grassroots organizations such as
NGO's to deliver rural services. We work with governments on policy
reform to shift resources and attention to basic care and prevention.
We work with our donor colleagues to help build systems which reach the
poor, strengthen management and referral capabilities, and which help
assure sustainability.
USAID promotes impact monitoring and evaluation in all of its
projects. We work with host country governments and NGO's to develop
monitoring and evaluation systems designed to track indicators at the
grassroots level, such as children immunized, persons receiving
``quality care,'' women understanding how to recognize infection, and
people knowing when to immunize their children.
(C) One hundred million infants per year need immunizations. Can
you tell me a little about the progress made in vaccine self-
sufficiency on the part of developing countries?
Answer. Significant improvement has taken place in the number of
countries that are now paying for all or part of their vaccines. At
least 20 developing countries are now paying their entire vaccine bill.
Fifteen more pay more than half of their own vaccine costs. But in many
of the least developed countries, host country resources cover only 5
to 25 percent of the costs of their total vaccine needs.
To promote vaccine self-sufficiency, USAID is working with host
countries to strengthen their capabilities to (1) issue tenders to
procure vaccines competitively on the international market; (2)
regulate vaccine quality at the national level; (3) improve vaccine
handling and delivery; (4) improve and introduce more efficient
schedules for vaccination; and (5) reduce vaccine wastage. This
strategy--which focuses on strengthening the capacity of local
governments and non-governmental organizations--is one of the main
reasons for the continued high immunization coverage levels in most
developing countries since 1990.
Vaccine self-sufficiency is, however, a multi-faceted goal. USAID
has directly promoted vaccine self-sufficiency by helping host
countries develop strategies for reducing waste and inefficiency. For
example:
--In Krygystan, changes in vaccination guidelines and practices
between 1995 and 1996 reduced wastage of DPT vaccine by almost
50 percent;
--Introduction of vaccine vial monitors, which indicate whether
vaccines exposed to excessive heat and therefore possibly
damaged are still effective, have helped to reduce wastage of
oral polio vaccine by up to 30 percent, saving an estimated $10
million a year globally;
Implementation of improved schedules for immunization in the five
Central Asian Republics is estimated to save $1 million a year.
vitamin and mineral deficiencies
Question. Deficiencies in essential vitamins and minerals can lead
to blindness, mental retardation, physical deformities and even death.
Yet treatment of these deficiencies can be simple and inexpensive.
(A) Among the most cost-efficient interventions available is the
administration of vitamin A, either orally or through fortified foods.
Can you tell me more about efforts underway in this endeavor? How can
we help to ensure that the limited foreign aid funding for vitamin A
programs is actually used as appropriated?
Answer. USAID is spending more than $20 million annually on
interventions to address micronutrient deficiencies in populations in
need. More than one-half of the Agency's sub-earmark for micronutrients
is spent to reduce vitamin A deficiency.
USAID-supported research was key in proving that vitamin A improves
child survival dramatically, by 20 to 30 per cent in deficient
populations. USAID has agreed to ``push the envelope for vitamin A
delivery to children in need.'' Over the next five to seven years, we
will focus our efforts in three to four countries where vitamin A
deficiency is a problem and where we believe that U.S. government
resources can make a real difference to child survival. We will also
coordinate with our bilateral and multilateral donor colleagues to
promote and deliver vitamin A to vulnerable populations.
We are presently helping to fortify foodstuffs in Bolivia (sugar),
Guatemala (sugar), El Salvador (sugar), Sri Lanka (flour), and
anticipate supporting future fortification efforts in Zambia and the
Philippines. These activities will dramatically improve vitamin A
sufficiency in needy populations and are expected to improve child
survival dramatically.
Use of Funding: By working with public and private sector entities
on fortification efforts, we are helping to create an internal market
which will improve distribution and limit inappropriate use of U.S.
government resources. Public-private partnerships, which are built on
the local economy and focus on creating local demand, are self-
sustaining. Vitamin A fortification, along with iron and iodine
fortification of foods can help to foster widely sustainable ways of
reducing micronutrient deficiencies.
(B) What types of efforts are underway to add vitamin A to foods
that are regularly traded to the developing world?
Answer. At present, USAID is not exploring efforts to fortify foods
that are traded to the developing world. Our approach is to focus on
locally produced foods and add fortificants appropriately so they will
be routinely consumed by the local population, and thus be a more
sustainable effort.
aids/hiv
Question. AIDS/HIV is one of the most frightening of the new
diseases encountered in the last 20 years. The rate of infection among
developing countries is staggering; everyday more than 6,000 new people
are infected, half of whom are adolescents. The disease is rapidly
spreading to the heterosexual population, with new infections
concentrated in 15 to 25 year olds.
(A) What is the best way for the U.S. to efficiently utilize global
AIDS funding to prevent the further spread of this terrible virus, both
at home and abroad?
Answer. USAID, working closely with host country governments,
indigenous NGO's, the private sector, and the international donor
community, has been the world's leader in developing state-of-the-art
prevention interventions, and is the world's largest donor to this
effort. In the past year, USAID, in collaboration with its partners,
has redesigned its portfolio to respond to the growing and changing
worldwide epidemic. This has resulted in an expanded strategy which
will incorporate successful programs developed over the past several
years, as well as strategies which address new and developing aspects
of the epidemic such as the surging tuberculosis, childhood mortality
and orphan rates. This expanded response will focus on:
--(1) Field support to missions (technical assistance, training,
materials production, support of communication campaigns and
delivery of STI clinical services) to implement interventions
which reduce sexually transmitted infections and high risk
behaviors.
--(2) Field support to missions to implement condom distribution
interventions for HIV/AIDS prevention and control.
--(3) Identification, refinement, and improvement of ``best
practices'' through operations research, field testing of
program interventions, and the review of scientific studies and
publications.
--(4) Field support in the design, monitoring, and evaluating of
programs; collection and dissemination of technical lessons
learned to field missions, cooperating agencies, governments
and international donors to ensure the understanding and use of
successful strategies.
USAID will also support activities to establish and improve HIV/STI
surveillance systems, build local PVO/NGO capacity, conduct selected
biomedical research (specifically to support the development of a
vaginal microbicide, inexpensive STI diagnostics, and potentially to
adopt a proven vaccine for use in resource-poor settings). We will also
provide technical assistance and operations research to assist Missions
in the development of rational, strategically sound basic care
alternatives for HIV infected persons and support for the survivors
which would enhance their prevention goal, promote policy dialogue, and
support UNAIDS and the six cosponsoring agencies of the United Nations.
To maximize the impact of these primary prevention interventions,
USAID's revised strategic approach will insure that:
--(1) the most appropriate countries, settings, and vulnerable
populations are reached;
--(2) the number of beneficiaries of behavior change and STI
interventions is increased;
--(3) programs focus more closely on how to renew and refresh
behavior change interventions to maintain long term behavior
change for safer sex practices;
--(4) partners at country level (mainly indigenous NGO and CBO's who
perform the bulk of the most effective interventions)
collaborate closely to increase technical and management
capacity, and ultimately achieve autonomy and long term
sustainability.
(B) What measures have been shown to be most effective and cost-
efficient in educating people and preventing the spread of HIV in
developing countries?
Answer. More than 70 percent of HIV transmission is through
heterosexual contact. USAID's strategy, therefore, focusses primarily
on preventing sexual transmission. Over the past five years, the
effectiveness of the three primary interventions to reduce sexual
transmission, cited below, has been dramatically proven:
--(1) Reducing the prevalence of other sexually transmitted
infections. In Tanzania and Malawi, studies have documented a
42-percent decrease in new HIV infections after the
implementation of proper clinical management of sexually
transmitted infections.
--(2) Increasing the distribution of condoms. In Thailand, increasing
the use of condoms in commercial sex establishments has led to
a decrease in HIV prevalence from 3.6 percent in 1993 to 2.5
percent in 1995 (a 30-percent drop).
--(3) Changing high risk sexual behavior through behavior change
communication. In Uganda, this approach has resulted in a 35-
percent reduction in HIV prevalence in young women aged 15-24
through a program encouraging delayed onset of sexual activity
and safer sexual practices.
Overall, since 1989, USAID-funded programs have educated over 15
million persons, trained over 150,000 persons as educators, improved
STI programs in 19 countries, and distributed over 200 million condoms.
surveillance
Question. The Institute of Medicine reported in its 1992 ``Emerging
Infections'' report that the surveillance of diseases needs to be
improved both within the U.S. and overseas. Of the 15 recommendations
made in the IOM report,the first five are all related to improving
disease surveillance. It also recommends that the National Institutes
of Health, the Department of Defense and the Centers for Disease
Control all work together toward this goal.
(A) Could you please take a moment to discuss what the U.S.
currently does to monitor the outbreaks of infectious diseases abroad
and what U.S. agencies are involved?
Answer. Several U.S. Government agencies are involved in
surveillance, including the Department of Defense (DOD); the Department
of Health and Human Services (DHHS), including the Centers for Disease
Control and Prevention (CDC); the Department of State; USAID; and to a
lesser degree, the U.S. Customs Service, and Departments of Agriculture
and Transportation.
To focus on the major players, the Department of Defense monitors
outbreaks through its own extensive system of reporting, which includes
its laboratories overseas. The Department of Health and Human Services,
especially through the Centers for Disease Control and Prevention, has
an extensive informal network of epidemiology and laboratory
connections, with reporting channels for the World Health Organization
as well. USAID's Office of Foreign Disaster Assistance is also involved
in surveillance as well, although primarily at a second stage; that is,
in keeping up with outbreak situations, including notifications from
embassies, and from its networks of emergency and disaster relief
organizations.
USAID's focus in surveillance is in the development of host country
capabilities in surveillance, a critical element in assuring
sustainable and effective surveillance over the long run. USAID is
particularly active today in supporting polio surveillance which may
serve as the foundation for integrated surveillance in some African
countries.
(B) What are your views on what can be done to improve monitoring
capabilities and prevent a widespread epidemic?
Answer. Inadequate in-country capabilities for epidemiologic
surveillance and inadequate incorporation of epidemiologic principles
into health systems' operations are major hindrances to the recognition
and timely control of infectious diseases, including Emerging,
Reemerging and Infectious Diseases (ERID's).
Acute outbreak epidemiologic investigations are invaluable tools
when they are required. At least equally important, however, but
sometimes overlooked, are systems to monitor epidemiologic trends over
time--for example, changing patterns of antimicrobial resistance,
changing risk groups for illnesses, new population groups being
affected, etc.
Health systems which lack systems to identify and monitor ``usual''
patterns of disease often will not be able to recognize ``unusual''
events or outbreaks of new problems, or changes in the patterns of
previously ``controlled'' diseases. Therefore, health systems without
routinely available and applied epidemiologic expertise, without the
interest and mandate to monitor diseases and investigate outbreaks, and
without budget, support-staff, and transport for epidemiologic
activities will, predictably, have difficulties recognizing and
containing ERID's.
To have adequate in-country epidemiologic capabilities requires not
only specialized, epidemiologically-sophisticated professional staff,
but also dedication of substantial health system resources to support
routine as well as ``emergency'' epidemiologic work.
Note: Each country needs, at the very least, a core group of well-
trained epidemiologists. In smaller countries, it may be wishful
thinking that the rare, trained epidemiologist(s) will be able to work
full-time on epidemiology; however, it is important that this highly
trained resource should be immediately available, and used, at least
for urgent work on putative outbreaks.
To sustain this commitment over time (i.e., between emergencies)
requires health system managers, and political leaders, to understand
and accept the value of investments in epidemiologic work. Competent
epidemiologic capacity cannot be established on an emergency basis in
response to sudden crises. Competent epidemiologic capacity must pre-
exist outbreaks. Few developing country governments judge the
expenditures and efforts to maintain competent epidemiology systems to
be worthwhile investments when compared to other demands. USAID plays a
critical role in building this capacity through training and
institutional strengthening.
In addition, a portion of USAID's funding is made available to deal
rapidly with potentially catastrophic or epidemiologically important
outbreaks, ranging in scale from such circumstances as the Ebola
outbreak in 1995, to recent investigations of the potentially
important, resurgences of monkeypox and O'nyong-nyong fever in central
Africa.
conclusion of hearing
Senator Leahy. So I thank all five of you or all six of
you who have testified here today or who have briefed us, as
Dr. Heymann has today, and thank you very much for being here.
The subcommittee will stand in recess subject to the call
of the Chair.
[Whereupon, at 12:15 p.m., Thursday, May 15, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]