U.S. GOVERNMENT PRINTING OFFICE

44–070 cc WASHINGTON : 1998

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

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(II)

COMMITTEE ON APPROPRIATIONS

TED STEVENS, Alaska, Chairman

THAD COCHRAN, Mississippi

ARLEN SPECTER, Pennsylvania

PETE V. DOMENICI, New Mexico

CHRISTOPHER S. BOND, Missouri

SLADE GORTON, Washington

MITCH MCCONNELL, Kentucky

CONRAD BURNS, Montana

RICHARD C. SHELBY, Alabama

JUDD GREGG, New Hampshire

ROBERT F. BENNETT, Utah

BEN NIGHTHORSE CAMPBELL, Colorado

LARRY CRAIG, Idaho

LAUCH FAIRCLOTH, North Carolina

KAY BAILEY HUTCHISON, Texas

ROBERT C. BYRD, West Virginia

DANIEL K. INOUYE, Hawaii

ERNEST F. HOLLINGS, South Carolina

PATRICK J. LEAHY, Vermont

DALE BUMPERS, Arkansas

FRANK R. LAUTENBERG, New Jersey

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

BYRON DORGAN, North Dakota

BARBARA BOXER, California

STEVEN J. CORTESE, Staff Director

LISA SUTHERLAND, Deputy Staff Director

JAMES H. ENGLISH, Minority Staff Director

SUBCOMMITTEE ON FOREIGN OPERATIONS, EXPORT FINANCING, AND RELATED

PROGRAMS

MITCH McCONNELL, Kentucky, Chairman

ARLEN SPECTER, Pennsylvania

JUDD GREGG, New Hampshire

RICHARD C. SHELBY, Alabama

ROBERT F. BENNETT, Utah

BEN NIGHTHORSE CAMPBELL, Colorado

TED STEVENS, Alaska

PATRICK J. LEAHY, Vermont

DANIEL K. INOUYE, Hawaii

FRANK R. LAUTENBERG, New Jersey

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

PATTY MURRAY, Washington

ROBERT C. BYRD, West Virginia

(Ex officio)

Professional Staff

ROBIN CLEVELAND

TIM RIESER (Minority)
(III)

CONTENTS

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
(1)

COMBATING INFECTIOUS DISEASES

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
2

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,
3

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.’’
4

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.
5

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 wellknown 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 ques-
6

tions 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.
7

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 subSaharan 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
8

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
9

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
10

by communicable perinatal and maternal mortality, all of which are ultimately

caused by infectious diseases.

TABLE 2.—Burden of disease developing countries, 1990

Percent DALYS1

Communicable, perinatal ...................................................................................... 48.7

Cardiovascular ....................................................................................................... 8.2

Neoplastic ............................................................................................................... 4.0

Injuries .................................................................................................................... 15.2

1Disability 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 importa-
11

tion 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
12

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 publicprivate 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 for-
13

eign 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

Camp Devens, MA: Cases

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 ma-
14

laria 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.
15

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
16

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.
17

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.
18

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 <http://www.who.ch>.

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
19

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
20

1Document A48/15.

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

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
21

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 symp-
22

toms 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 fourpart 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
23

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
24

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 treat-
25

ment 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
26

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 pre-
27

vention 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
28

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 con-
29

trol 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.
30

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.
31

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.
32

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.
33

Merck developed one of these new HIV protease inhibitors, Crixvan, after a tenyear 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 ensur-
34

ing 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
35

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 pa-
36

tient 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.
37

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.
38

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.
39

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.
40

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?
41

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.
42

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 shortterm 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,
43

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
44

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 hippocket 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?
45

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.
46

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.
47

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.
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[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.
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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 onthe-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
50

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:
51

—(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).
52

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.]

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