[Senate Hearing 105-520]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 105-520


 
                     COMBATING INFECTIOUS DISEASES

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

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

                      COMMITTEE ON APPROPRIATIONS
                          UNITED STATES SENATE

                       ONE HUNDRED FIFTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                               __________

         Printed for the use of the Committee on Appropriations




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

                                 ______

                     U.S. GOVERNMENT PRINTING OFFICE
 44070 CC                 WASHINGTON : 1998
_______________________________________________________________________
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                           ISBN 0-16-057141-3



                      COMMITTEE ON APPROPRIATIONS

                     TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington             DALE BUMPERS, Arkansas
MITCH McCONNELL, Kentucky            FRANK R. LAUTENBERG, New Jersey
CONRAD BURNS, Montana                TOM HARKIN, Iowa
RICHARD C. SHELBY, Alabama           BARBARA A. MIKULSKI, Maryland
JUDD GREGG, New Hampshire            HARRY REID, Nevada
ROBERT F. BENNETT, Utah              HERB KOHL, Wisconsin
BEN NIGHTHORSE CAMPBELL, Colorado    PATTY MURRAY, Washington
LARRY CRAIG, Idaho                   BYRON DORGAN, North Dakota
LAUCH FAIRCLOTH, North Carolina      BARBARA BOXER, California
KAY BAILEY HUTCHISON, Texas
                   Steven J. Cortese, Staff Director
                 Lisa Sutherland, Deputy Staff Director
               James H. English, Minority Staff Director
                                 ------                                

   Subcommittee on Foreign Operations, Export Financing, and Related 
                                Programs

                  MITCH McCONNELL, Kentucky, Chairman
ARLEN SPECTER, Pennsylvania          PATRICK J. LEAHY, Vermont
JUDD GREGG, New Hampshire            DANIEL K. INOUYE, Hawaii
RICHARD C. SHELBY, Alabama           FRANK R. LAUTENBERG, New Jersey
ROBERT F. BENNETT, Utah              TOM HARKIN, Iowa
BEN NIGHTHORSE CAMPBELL, Colorado    BARBARA A. MIKULSKI, Maryland
TED STEVENS, Alaska                  PATTY MURRAY, Washington
                                     ROBERT C. BYRD, West Virginia
                                       (Ex officio)
                           Professional Staff
                            Robin Cleveland
                         Tim Rieser (Minority)



                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening remarks of Senator Patrick Leahy.........................     1
    Prepared statement...........................................     3
Opening remarks of Senator Mitch McConnell.......................     4
Statement of Barry R. Bloom, Ph.D., investigator, Howard Hughes 
  Medical Institute, and professor of microbiology and 
  immunology, Albert Einstein College of Medicine................     5
    Prepared statement...........................................     9
Statement of David Heymann, M.D., director, Division of Emerging 
  and Other Communicable Diseases Surveillance and Control, World 
  Health Organization............................................    14
    Prepared statement...........................................    17
Statement of Nils Daulaire, M.D., Chief Health Policy Advisor, 
  U.S. Agency for International Development......................    21
    Prepared statement...........................................    24
Statement of Gordon Douglas, M.D., president, Merck Vaccines, 
  Merck, & Co....................................................    28
    Prepared statement...........................................    31
Strengthening infrastructure.....................................    34
Statement of John Sbarbaro, M.D., professor of medicine and 
  preventive medicine, school of medicine, University of Colorado 
  Health Sciences Center.........................................    34
    Prepared statement...........................................    36
Seed money.......................................................    39
Additional committee questions...................................    47
Questions submitted by Senator Campbell..........................    48
  



                     COMBATING INFECTIOUS DISEASES

                              ----------                              


                         THURSDAY, MAY 15, 1997

                           U.S. Senate,    
        Subcommittee on Foreign Operations,
          Export Financing, and Related Operations,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:41 a.m., in room SD-138, Dirksen 
Senate Office Building, Hon. Patrick J. Leahy presiding.
    Present: Senators McConnell and Leahy.

                       NONDEPARTMENTAL WITNESSES

STATEMENT OF BARRY R. BLOOM, Ph.D., INVESTIGATOR, 
            HOWARD HUGHES MEDICAL INSTITUTE, AND 
            PROFESSOR OF MICROBIOLOGY AND IMMUNOLOGY, 
            ALBERT EINSTEIN COLLEGE OF MEDICINE


             opening statement of senator patrick j. leahy


    Senator Leahy. Good morning. This happens with all of us. 
Senator McConnell has the usual five different hearings and 
meetings going on at the same time and will join us in a bit.
    But I do want to note my appreciation to him as the 
chairman of this subcommittee for scheduling this hearing. It 
is good to have you here, Dr. Heymann. You have come all the 
way here from Geneva, and we appreciate that. The fact that you 
have done this demonstrates the World Health Organization's 
recognition of the need to discuss these issues, which have 
been virtually ignored by the Congress.
    I looked back 10 years and found one hearing that looked at 
the problem of infectious disease from a global perspective. 
That is pretty alarming when you consider the regularity of 
devastating epidemics throughout history, the potential threat 
to the health and economic well-being of millions of Americans 
and vast numbers of others, tens of millions more, people all 
over the world.
    Senator McConnell has pointed out this is an economic 
issue, a national security issue, when you consider the threat 
of biological warfare and terrorism. And it is of course a 
humanitarian issue, and anybody who has traveled around the 
world and seen the devastation of some of these epidemics would 
know that. I have. My staff has. My wife, who is a registered 
nurse, sees more and more patients with infectious diseases, 
like tuberculosis, that she did not see 10, 15 years ago.
    I also want to welcome the others who are here. Dr. Barry 
Bloom cochaired the 1997 institute of medicine study entitled 
``America's Vital Interest in Global Health,'' which was very 
helpful in preparing for this hearing. Dr. Gordon Douglas, who 
brings the perspective of the pharmaceutical industry as 
president of Merck Vaccines, has seen the difficulties facing 
us especially as more and more diseases become resistant to 
drugs we have used in the past.
    Dr. Nils Daulaire, is from my own State of Vermont, and Dr. 
Don Sbarbaro. You each have a great deal of experience from 
your work in public health--you, Dr. Sbarbaro in tuberculosis, 
most recently at the University of Colorado School of Medicine; 
and Dr. Daulaire from 20 years in primary health care in West 
Africa and the Himalayas, now at the Agency for International 
Development [AID].
    Ms. Laurie Garrett could not be here today because she is 
out of the country, but she is the author of the book ``The 
Coming Plague,'' which was also the subject of a recent four-
part television series, that has helped spotlight the urgency 
of this.
    You know, I remember as a child when you worried about 
smallpox. I remember as a child growing up in the small city of 
Montpelier, VT, when the swimming pool would be closed during 
polio scares. But we do not think of these things today. We got 
rid of smallpox, we got rid of polio. We thought we had 
eliminated all infectious diseases forever. As Laurie Garrett 
said:

    The world was a very optimistic place on September 12, 
1978, when the Nations' representatives signed the Declaration 
of Alma Ata. By the year 2000 all of humanity was supposed to 
be immunized against most infectious diseases, basic health 
care was to be available to every man, woman and child 
regardless of economic class, race, religion, or place of 
birth.
    But as the world approaches the millennium, it seems from 
the microbes' point of view as if the entire planet, occupied 
by nearly 6 billion mostly impoverished people, is like the 
city of Rome in 5 B.C. Our tolerance of disease in any place in 
the world is at our peril and, while the human race battles 
itself, the advantage moves to the microbes' court.
    They are predators and they will be victorious if we, homo 
sapiens, do not learn to live in a rational world that affords 
the microbes few opportunities. Either that or we brace 
ourselves for the coming plague.

                               aids virus


    Mr. Chairman, that plague is already here. By the year 
2000, 12 million people will be infected with the AIDS virus in 
India alone, 40 million people worldwide. Over 100,000 people 
were infected by HIV by 1980, before AIDS was even discovered, 
and 3 million people die every year worldwide from 
tuberculosis, a curable disease, and now a multi-drug-resistant 
form of TB poses a new, even more serious threat.
    Each year there are 250 million new cases of malaria, and 2 
million deaths. New drug-resistant forms are being transported 
around the world.
    The ebola virus, if it were to spread beyond isolated 
areas, think what it could do. We saw recently the panic in 
this city when somebody sent a few overripe strawberries 
through the mail. Imagine what would happen if the same amount 
of anthrax was scattered from the top of the Washington 
Monument.
    Over 2 million people each day cross our national borders. 
Since 1973 more than 30 new infectious diseases have been 
identified.
    We need the attention of Congress. America's pharmaceutical 
companies can make an enormous contribution to global health, 
but they face many obstacles. We need to hear from them what 
can be done. We sometimes think that technology can solve any 
problem, but it is not that easy.

                           prepared statement

    Mr. Chairman, we have lots of hearings to determine how 
many battleships to buy, how many aircraft carriers we need, 
how many wings of aircraft we need for our national security. 
But there are other threats that cross our borders, and 
everybody else's borders. Microbes do not worry about how many 
missiles you have aimed at them. They just go right past them.
    Thank you, Mr. Chairman.
    [The statement follows:]
              Prepared Statement of Senator Patrick Leahy
    Mr. Chairman, thank you very much for scheduling this hearing. It 
deals with issues I have been very concerned about for some time, and I 
appreciate the interest you have shown.
    I want to welcome our witnesses. Dr. Heymann, you get the prize for 
coming all the way from Geneva, and we appreciate that. Your being here 
demonstrates the World Health Organization's recognition of the need to 
discuss these issues, which incidently have been virtually ignored by 
the Congress.
    I searched back 10 years, and found only one hearing that looked at 
the problem of infectious diseases from a global perspective, which 
Senator Kassebaum held two years ago.
    That is pretty alarming when you consider the regularity of 
devastating epidemics throughout history, and the potential threat to 
the health and economic well-being of millions of Americans and vast 
numbers of people around the world. As you have pointed out, this is an 
economic issue, a national security issue when you consider the threat 
of biological warfare and terrorism, and a humanitarian issue.
    I also want to thank our other witnesses for being here. They bring 
a wealth of expertise, and each has made major contributions in the 
field of public health.
    Dr. Barry Bloom co-chaired the 1997 Institute of Medicine study 
entitled ``America's Vital Interest in Global Health.''
    Dr. Gordon Douglas brings the perspective of the pharmaceutical 
industry, as President of Merck Vaccines.
    Dr. Nils Daulaire and Dr. John Sbarbaro each have a great deal of 
experience from their work in the field of public health--Dr. Sbarbaro 
on tuberculosis, most recently at the University of Colorado School of 
Medicine, and Dr. Daulaire after 20 years in primary health care in 
West Africa and the Himalayas, now at the Agency for International 
Development.
    I also want to mention Ms. Laurie Garrett, who because she is out 
of the country could not be here today. But as the author of the book 
``The Coming Plague,'' which was also the subject of a recent four-part 
public television series, her efforts to focus attention on the urgency 
and complexity of the threat of infectious diseases deserves special 
recognition.
    Mr. Chairman, some of us are old enough to remember the terrifying 
days when anyone could wake up infected with smallpox or polio. You can 
speak from personal experience. Yet just twenty short years ago, with 
the eradication of smallpox and the discovery of the polio vaccine, 
people actually thought we were on the verge of eliminating infectious 
disease forever.
    As Laurie Garrett wrote: ``The world was a very optimistic place on 
September 12, 1978, when the nations' representatives signed the 
Declaration of Alma Ata. By the year 2000 all of humanity was supposed 
to be immunized against most infectious diseases, basic health care was 
to be available to every man, woman, and child regardless of their 
economic class, race, religion, or place of birth.
    But as the world approaches the millennium, it seems, from the 
microbes' point of view, as if the entire planet, occupied by nearly 6 
billion mostly impoverished people, is like the city of Rome in 5 B.C. 
Our tolerance of disease in any place in the world is at our peril. 
While the human race battles itself * * * the advantage moves to the 
microbes' court. They are our predators and they will be victorious if 
we, Homo sapiens, do not learn to live in a rational world that affords 
the microbes few opportunities. It's either that or we brace ourselves 
for the coming plague.''
    Mr. Chairman, in many respects, that plague is already here.
  --By the year 2000, twelve million people will be infected with the 
        AIDS virus in India alone, and there will be forty million 
        cases worldwide. Over 100,000 people were infected with HIV by 
        1980, before AIDS was even discovered.
  --Each year, 3 million people die worldwide from tuberculosis, a 
        curable disease, and multidrug-resistant forms of TB pose a 
        new, even more serious threat. After years of decline, TB re-
        emerged as a major public health problem in this country just a 
        few years ago.
  --Each year, there are some 250 million new cases of malaria, and 2 
        million deaths. New drug resistant forms are being transported 
        around the world.
  --The ebola virus, were it to spread beyond isolated rural parts of 
        Africa, could cause a similar catastrophe as the AIDS virus.
  --And we saw recently the panic caused by a few ripe strawberries 
        sent through the mail in Washington, DC. One can only imagine 
        what might result if the same amount of anthrax was scattered 
        from the top of the Washington Monument.
    The cost of stopping these microbial threats at our borders is no 
longer a realistic option. To quote from the 1997 Institute of Medicine 
study:
    ``The movement of 2 million people each day across national borders 
and the growth of international commerce are inevitably associated with 
health risks * * *. Poverty and violence impose major burdens on 
health, burdens that are shared by people in developing countries and 
in the inner cities of the industrial world alike. Due to the ease of 
rapid international travel, emerging and drug-resistant infectious 
diseases in one country represent a threat to the health and economies 
of all countries.''
    Since 1973, more than 30 new infectious diseases have been 
identified, and numerous known diseases have re-emerged as serious 
public health threats. Our failure to maintain and strengthen our 
ability to control the spread of these diseases has recently received 
attention, thanks in part to Laurie Garrett's book and films like 
``Outbreak.'' Last June, President Clinton announced a national policy 
to address the threat of emerging infectious diseases through improved 
domestic and international surveillance, prevention, and response 
measures.
    Other government-funded studies over the past several years have 
also warned of the dangers, and made numerous recommendations. However, 
as so often happens, many of those recommendations were ignored.
    Frankly, I am amazed that this topic has not received greater 
attention in the Congress. The Government has a responsibility to 
protect its citizens. America's pharmaceutical companies could make an 
enormous contribution to global health, but they face many obstacles. 
We know what needs to be done, yet we continue to treat one of the most 
serious threats we face with the same kind of naive optimism as we did 
20 years ago.
    Perhaps it is because microbes are invisible to the naked eye, and 
we assume that technology can defeat any disease, that we have not done 
more about it. I hope our witnesses will explain why things have not 
turned out as was predicted back in 1978, what dangers infectious 
diseases pose today, and what this subcommittee should do about it.
    Thank you.

             opening statement of senator mitch mc connell

    Senator McConnell [presiding]. Thank you, Senator Leahy.
    The reason for our hearing today really is Senator Leahy's 
interest on this subject, and he is to be commended for 
suggesting it and deserves the credit for this public 
discussion today. Having been a victim of polio as a child, I 
have a personal interest in this area. I believe we are finally 
close to eliminating polio from the face of the Earth, in part 
due to a dedicated effort by international health 
organizations, bilateral aid programs, and active involvement 
of nongovernment organizations and community activists.
    But polio should not be the only targeted disease. We need 
to see the same kind of effort concentrated on tuberculosis, 
malaria, diphtheria, to name just a few. Senator Leahy has 
already mentioned this. From my perspective, there are several 
reasons to focus our attention and resources on the problem of 
infectious disease.
    First, it is consistent with our humanitarian traditions. 
Right now one person dies every 15 seconds from malaria. Of 
those deaths, 85 percent are children under 5 years old. We 
need to add malaria, measles, and polio to the short list of 
fatal diseases, including smallpox, which we have essentially 
erased from the Earth.
    This is not just an issue of saving children. The spread of 
infectious diseases directly affects both our personal safety 
as well as our economic and national security. We need an 
effective surveillance system to assure our blood supply is not 
contaminated by emerging deadly microbes. At this point we can 
screen out well-known bacteria or viruses, but I am not 
confident we have the national or international mechanisms in 
place to protect us from emerging deadly agents.
    We need to coordinate prevention, diagnosis, and treatment 
programs for TB, which by some estimates is harbored by more 
than 2 billion people worldwide, the majority of whom are in 
Mexico, China, and Russia.
    Last year we provided emergency assistance to combat the 
diphtheria epidemics in Russia and Ukraine. While I think this 
aid was helpful, it was a stopgap measure, not a part of a 
comprehensive strategy for the NIS.
    These epidemics have a human face, but economic cost. Just 
as one example, 1995 estimates of health care and lost 
production in tropical Africa from malaria run nearly $2 
billion, a staggering toll for a destitute continent.
    Finally, while some may still be indifferent to the human 
or economic interests at stake, there is no question that 
improving surveillance, control, and treatment of these 
diseases have real national security implications. A few weeks 
ago 100 people were quarantined for 8 hours in northwest 
Washington in response to an anthrax scare. Pat mentioned that. 
While it turned out to be a sadistic hoax, the drill was a live 
demonstration of the problems we may face in the future.
    In spite of a global convention banning the production, 
distribution, or acquisition of biological weapons, 10 
countries are suspected of having just such programs. Iraq has 
acknowledged manufacturing 25,000 liters of an anthrax 
bacterium, which is sufficient to kill the Earth's population 
three times over.
    I certainly hope we get a better sense today of the 
commercial and government research programs which may be 
developing vital antidotes, antibiotics, and vaccines to this 
threat.
    Our panel of experts represents a unique spectrum of 
expertise on the extent of the threat and medical and 
organizational responses. I understand that Dr. Heymann, who 
represents the World Health Organization, is not permitted to 
formally testify, so we will accommodate his agency rules by 
allowing him to brief us.
    I will be leaving for a meeting around 11:30 a.m. Senator 
Leahy is going to conduct the hearing and finish it up. Now we 
would like to lead off with Dr. Bloom.

                    summary statement of barry bloom

    Dr. Bloom. Thank you, Mr. Chairman, Senator Leahy. It is a 
great privilege to be here to talk about infectious diseases in 
this committee. I would like to use my testimony to address 
three questions to set the background for the discussion of my 
colleagues that I hope will follow. The first is: Are 
infectious diseases really important? Second: What do we have 
to offer to address them and the problems of health of 
developing countries? And the third is: What do we have to gain 
by it? What is our self-interest?
    If one looks at the question of any disease and its 
importance, perhaps the best place to look is a comparison of 
the global burden of disease, which I have illustrated here.
    The bar graphs indicate how many people die of what kinds 
of diseases. It makes two simple points. The largest cause of 
death in the world is not heart disease, cancer, or injuries; 
it is communicable diseases. And the second point is the deaths 
are not equitably distributed between the industrialized and 
the developing world, but fall predominantly on people who live 
in the developing countries.
    If one looks then at the burden of infectious diseases in 
developing countries and looks in fact at the total burden of 
disease, of the eight major causes of death and disability in 
developing countries, six of them--respiratory, diarrheal, 
perinatal, tuberculosis, measles, and malaria--are the largest 
burdens of disease. And if one asks what is the impact of 
infectious diseases on the future generation of developing 
countries, one finds that 70 percent of the causes of death of 
children under the age of 5 are caused by infectious diseases. 
So the burden of ongoing infectious diseases is enormous and it 
is the major health burden in developing countries.
    You have read a lot of media, I am certain, about emerging 
infections. The question is is this a major problem or is this 
an epidemic of the media? I would simply show you that, if one 
looks through history, this is a constant and grim battle 
between microorganisms and the human hosts for survival.
    These are epidemics that wiped out vast numbers of people 
in Europe that have been recorded in history from the Black 
Death to 40,000 deaths in Italy to malaria. This is a 
continuing evolutionary struggle, not a transient epidemic of 
the press.
    The second major concern in the area of emerging infections 
is drug resistance. Unless there are health infrastructures to 
properly use the drugs, we already know resistance is 
developing to pneumonia, malaria, TB, HIV, and all of those 
resistant organisms threaten the armamentarium at home and our 
ability to address these problems.
    The final concern that was mentioned in the introductory 
remarks is biological terrorism. I could make up a scenario. I 
think it is just easier to show a historical scenario, not 
intentionally introduced, but could be done by genetic 
engineering or by natural evolution. In September 1918 there 
was a single case at Fort Devens, MA; 5 days later there were 
almost 7,000 cases; 10 days later there were 12,000 cases; 25 
percent of the civilian population in the United States was 
infected and in fact 40 million people died from that outbreak. 
That is not able to be precluded on scientific grounds.
    Numbers reflect one aspect. This is a child with cerebral 
malaria. This is the kind of malaria that kills children, over 
1 million kids each year. That child was too late for medical 
help and succumbed.
    And 200 million people, as you know, over 1 million kids, 
and resistance is dramatically rising.
    The first resistance was detected in 1910. It took 60 years 
or 50 years for the resistance to chloroquine. We now have 
resistance in 4 years in Asia to the only drug available, and 
it is my understanding, Senators, that there is not a single 
major pharmaceutical company in the world developing drugs 
against this disease.
    AIDS, as you know, affects a vast number of people and is 
the most serious new threat to the health of people in 
developing countries. The numbers are staggering. The two that 
I would reflect are that 3 million kids have this disease and 
have died, and there are at least 9 million children that have 
lost at least one parent or are orphaned by this disease, so 
that the long-term social as well as health consequences, 
particularly in developing countries, are enormous.
    This is a disease that affects equal numbers of women and 
men in the developing countries, and also children.
    And the impact already is that the life expectancy in five 
sub-Saharan countries is declining, the first time we have ever 
seen a decline in recent years due to a health epidemic.
    I am not sure we can get past that.
    OK, great.
    Finally, there is the problem of tuberculosis. It is the 
largest cause of death in the world from any infectious 
diseases. It is responsible for 18 percent of adult premature 
mortality that could be prevented, and it is emerging as 
resistant to drugs and requires major attention.
    Senator Leahy. Let me just note Dr. Bloom, that my wife is 
a nurse at nearby hospital. She said, in the last 5 years there 
has been a steady increase in TB patients. And of course, that 
means increased precautions they have to take with special 
rooms and care and everything else.
    She said that, talking with some of the other nurses of her 
age, they have gone for 20 years almost never seeing a 
tuberculosis patient.
    Dr. Bloom. That is right.
    Senator Leahy. And now they are just a very common thing.
    Dr. Bloom. And it is sad when it is drug-resistant and we 
have no tools to deal with it, so it has to be dealt with. I am 
pleased to say the numbers in the United States for the first 
time have begun to decline.
    What I have said is to argue that infectious diseases are a 
major burden in the world and the major burden in the 
developing countries. What do we have to offer? I would argue 
with a single bit of evidence: this is what we have best to 
offer. These are data from the World Bank and they compare per 
capita income and life expectancy, and they show two things:
    If you are very, very poor, a very small increase in per 
capita income, on the left side of that chart, gives you a very 
significant increase in life expectancy. Any interventions that 
help self-reliance of the poorest will lead to an increase in 
life expectancy.
    But what we have uniquely to offer in addition is seen on 
the right side of the chart. If you lived in 1900, no matter 
how much money you had, you could not buy 25 years of life that 
we have available to us for the same income in 1990. And since 
these are income-adjusted figures, what it says is that 
difference, 25 years of life, has to be derived from, in the 
broadest sense, public health and medical knowledge. What we 
have to offer is a unique expertise in medical knowledge that 
buys life.
    The Board of International Health then asked the third 
question in its report, ``America's Vital Interest in Global 
Health'': What is in it for the United States? There were four 
reasons that we believe it is within the national interest.
    One is, as you well know, a great humanitarian tradition in 
this country. And I will not deal with it now, but we could 
discuss it later. Many polls indicate the American people are 
very supportive of foreign aid if it goes to the neediest, if 
it is to increase self-reliance, and if it is to get the job 
done that we are trying to get done.
    On the other hand, we are concerned, as I am sure you are, 
that foreign aid in this country and globally has declined for 
6 years and that this may not be a sufficient justification. So 
there are three other arguments we have tried to educe.
    One is to protect our people.
    Some 25 million travelers travel each year; 2 million go 
across borders; 148 million are refugees; 10 countries each 
have 70,000 refugees each on a permanent basis from foreign 
countries and 70 million people work across national borders. 
There are infectious diseases. There is urban crowding, and 
there is the transport of health hazards, including toxins.
    There are three reasons, then, to protect the American 
people. I will only mention two. One is the need for 
surveillance that you will hear about later, to identify what 
the threats are in infection. But the one that I think is the 
least understood is value for money.
    We tested whopping cough vaccine, not in the United States 
but in Scandinavia, because we could get value for money. They 
have more cases that we could evaluate. We studied cancer in 
China because they have more esophageal cancer than we have 
here and we get value for money. That is not foreign aid. That 
is common sense.
    I will argue in my professional judgment the most important 
thing in AIDS that the NIH and Government have recognized is 
the need for a vaccine. I believe for ethical reasons we cannot 
test any vaccine for AIDS for efficacy in the United States. We 
will need to test it in countries that have the highest disease 
rates, that cannot afford the drugs that are available. That is 
in our vital interest.
    Second, prevention is the name of infectious diseases and 
prevention not only helps people, it saves money. We save a 
vast amount of money not having to vaccinate against smallpox. 
We will do the same for polio. Measles is on the agenda. We 
save money as we vaccinate our kids here. For every dollar we 
put in, we gain in spared health costs $21 to $29. This makes a 
lot of sense.
    The second--the third argument that the Board on 
International Health educed is that the global health economy 
is $1.6 trillion. That is 8 percent of the world's economic 
product. We are the leader in development of science and new 
products. We are not the leader, however, in sales and exports 
to developing countries. The Europeans have 75 percent of that 
market, and there are major legislative, congressional and 
economic constraints to allowing American industry to compete 
effectively abroad. And I should also add, there are 2 billion 
people in developing countries that have no expertise--no 
access to the drugs that are available to people in this 
country.
    Finally, the last is that we have an opportunity to 
increase U.S. global influence in the world. We have the 
greatest amount of science and technology. It should be based 
on that. That is our comparative advantage. It should be put 
into educating people to help upgrade infrastructures in health 
abroad. It should be put into organizing and coordinating the 
many agencies that have statutory responsibility in the Federal 
Government, but, in an uncoordinated way without that 
leadership, are unable to deliver that leadership.

                           prepared statement

    If we want to influence the global health community, such 
as the World Health Organization, through the United Nations 
system, we really ought to pay our dues so that we can be taken 
seriously as a leader in that regard.
    I have tried to argue simply three points: infectious 
diseases are important, enormously important globally; the 
United States has unique strengths and capability to make a 
contribution; and we have much to gain.
    Thank you very much for your attention.
    [The statement follows:]

              Prepared Statement of Barry R. Bloom, Ph.D.

    I am Dr. Barry R. Bloom, an Investigator at the Howard 
Hughes Medical Institute and Professor of Microbiology and 
Immunology at the Albert Einstein College of Medicine in New 
York. At the present time I serve as Co-Chair of the Board on 
International Health of the Institute of Medicine of the 
National Academy of Sciences, and as Chairman of the Vaccines 
Advisory Committee to UNAIDS. I am most grateful for the 
opportunity to make a presentation on the importance of global 
infectious diseases and international health to this committee. 
My testimony will seek to address two questions relevant to 
these hearings: What is the global context for the major 
infectious disease challenges which my colleagues will discuss 
here today? and, Why is it in America's vital interest to 
engage in global health activities?

                the global burden of infectious diseases

    To evaluate the importance of any particular health 
problem, it is useful to consider the global burden of 
mortality and disease. The major cause of death in the world is 
not cardiovascular disease, cancer or injuries, but infectious 
disease. [1] If one combines the burden of premature mortality 
together with long-term disability, a useful metric can be 
derived for measuring the burden of disease and disability, 
known as disability adjusted life years or DALYS [2].

Table 1.--The global burden of disease, DALYS

                                                                Billions

Established market economies plus former Socialist economies...... 0.161
Developing countries.............................................. 1.220
                        -----------------------------------------------------------------
                        ________________________________________________
      Global total, 1990.......................................... 1.381

Note.--Disability adjusted life years lost (DALYS) equals premature 
mortality plus long-term disability.

    Using either metric, it becomes immediately apparent that 
the global burdens of mortality or disease are not equitably 
distributed. The vast burden of premature mortality and 
disability falls disproportionately upon people in developing 
countries. If one focuses directly on the health problems of 
the developing countries themselves, almost 50 percent of the 
burden of disease and disability is accounted for by 
communicable perinatal and maternal mortality, all of which are 
ultimately caused by infectious diseases.

Table 2.--Burden of disease developing countries, 1990

                                                       Percent DALYS \1\

Communicable, perinatal...........................................  48.7
Cardiovascular....................................................   8.2
Neoplastic........................................................   4.0
Injuries..........................................................  15.2

\1\ Disability adjusted life years lost.

    Of the eight leading causes of death and disability in developing 
countries, six are directly or indirectly caused by infectious 
diseases, lower respiratory infectious, diarrhoeal diseases, perinatal 
conditions, tuberculosis, measles, and malaria. HIV infection is the 
disease most rapidly increasing in developing countries.
    Of the eight leading causes of death and disability in developing 
countries, six are directly or indirectly caused by infectious 
diseases, lower respiratory infectious, diarrhoeal diseases, perinatal 
conditions, tuberculosis, measles, and malaria. HIV infection is the 
disease most rapidly increasing in developing countries.
  Table 3.--Global burden of disease and disability ranking causes in 
                     developing countries, 1990 [2]
(1) Lower Respiratory Infections
(2) Diarrhoeal Diseases
(3) Perinatal Conditions
(4) Unipolar Depression
(5) Tuberculosis
(6) Measles
(7) Malaria
(8) Ischemic Heart Disease

    If one considers only the burden of mortality on the future 
generation of developing countries, children under five years of age, 
infectious diseases represent the cause of 70 percent of deaths. Thus, 
for the 85 percent of the world's population living in developing 
countries, infectious diseases remain a major burden and priority; yet 
the scientific and technical means for addressing these problems lie in 
the hands and expertise of the 15 percent of the world's population 
living in the industrialized world.
    The atomic physicist, Leo Szilard, once defined an optimist as, 
``one who believes the future is uncertain.'' In addition to the major 
infectious diseases that have burdened humanity for centuries, the 
media and public have become aware of new and emerging infectious 
diseases. To address any concerns that the emerging infectious disease 
are a recent invention, or an epidemic of the press, let me remind you 
that the grim evolutionary battle between the pathogens and their human 
hosts for survival has endured from historic times, and that emerging 
infections are not a phenomenon only of recent years.

Table 4.--Emerging infectious diseases--a historical perspective

        Epidemic                                                    Year

Leprosy...........................................................   644
Smallpox (Rhazes).................................................   900
Black Death (plague)..............................................  1348
The great pox (syphilis)..........................................  1495
The red sickness (scarlet fever)..................................  1510
Jail fever (typhus)...............................................  1546
Malaria...........................................................  1557
Smallpox..........................................................  1567

    These are but a few of the terrible epidemics of Europe that have 
been recorded, that establish the continuing threat of new and emerging 
infections entering the human population. Among the newest and most 
serious threats are microbes developing resistance to antimicrobial 
drugs, often due to their inappropriate use. The drug resistant 
organisms are increasingly causing pneumonia, meningitis, malaria, 
tuberculosis, sexually transmitted diseases, particularly gonorrhea, 
and HIV.
    the importance of three major infectious diseases of developing 
                               countries
    Of the infectious diseases that are particular burdens for 
developing countries, I would like to focus attention on three. Malaria 
is a major parasitic disease transmitted by mosquitoes that infects 
over 200 million people each year in Africa, Asia and Latin America. It 
affects citizens of the United States largely through its importation 
with travelers and is a major threat the military stationed in tropical 
countries. Malaria kills a million children each year, and resistance 
to drugs is rapidly rising. Resistance to quinine developed in 1910, 
resistance to chloroquine was reported in 1967 and four years after the 
introduction of mephloquine, the newest antimalarial drug, resistance 
has developed particularly in Asia. On the ThaiCambodian border, over 
60 percent of malaria is resistant to all the anti-malarial drugs. 
Because malaria is a disease primarily of developing countries, there 
are virtually no new drugs in the pipeline, and it is my understanding 
that not a single major pharmaceutical company worldwide is engaged in 
developing new drugs for this disease.
    AIDS is the recently emergent virus infection that is devastating 
the poorest countries in the world, and will continue to do so for the 
foreseeable future. UNAIDS estimates that there are 22.6 million people 
infected with HIV and 6.4 million have already died of AIDS, including 
3 million children. Almost 100 million children have lost a mother or 
are orphaned from AIDS. It is a tragic fact that 90 percent of HIV-
infected people live in developing countries that cannot afford the new 
and expensive drugs that cost perhaps $15,000 per year. UNAIDS 
estimates that 40 million people will have died from AIDS by the end of 
this decade. In United States, where the Centers for Disease Control 
(CDC) has excellent surveillance figures, HIV is the most rapidly 
rising and now leading cause of death of men aged 25-44, and the 
picture in developing countries is that women share 46 percent of the 
burden of HIV. The devastation of this disease in sub-Saharan Africa is 
reflected by the fact that life expectancy in sub-Saharan countries 
which had been steadily rising from the mid-1970's has started to 
decline and will continue to decline because of the impact which this 
disease is having on its young and most productive people.
    The third disease is tuberculosis, which remains the largest cause 
of death in the world from any single infectious disease. There are 
over 7 million new cases each year of tuberculosis, 2 million deaths 
annually. In Africa, it is the most common cause of death in people 
whose immune system is weakened by HIV infection, and the attributable 
cause of death of over 30 percent of AIDS patients there. Particularly 
ominous, as we learned recently in New York, is the emergence of 
multidrug resistance. We have learned that unless drug treatment is 
properly supervised, tuberculosis rapidly becomes resistant to the only 
effective drugs available. The lesson was learned originally in 
Tanzania and replicated in New York, and showed that directly observed 
treatment (DOTS) both prevents emergence of resistance and leads to 
cures in over 85 percent of tuberculosis patients rendering them non-
infectious within a month. For malaria and AIDS afflicting people in 
developing countries, for which drugs are either not available or 
prohibitively expensive, and for tuberculosis where treatment is long, 
the long-term hope is for development of preventive vaccines.
   four major who extra budgetary programs that can make a difference
    For each of these diseases I would suggest that extra budgetary 
programs at the World Health Organization, specifically the Tropical 
Disease Research (TDR) Program, Global Program for Tuberculosis (GTB), 
and the new Programme on Emerging Infections, and the UNAIDS Programma 
that unifies efforts of all the UN Agencies, have the potential to make 
an enormous difference, and would urge you to give them consideration 
for increased financial support. Over 30 years, I have served all but 
one of these programs. As Chairman of the Scientific and Technical 
Advisory Committee to the Tropical Disease Research Program I was 
responsible for reporting to the donor group and the co-sponsors, the 
United Nations Development Program (UNDP) and The World Bank, on the 
scientific progress and integrity of that program. In my judgment, and 
in the words of the representative from the British Overseas 
Development Agency, ``there is no program in foreign assistance that 
receives a higher level of technical expertise or more stringent 
review''. In terms of capacity building, the WHO TDR program has 
trained more scientists working in biomedical research in developing 
countries than any other program, and over 90 percent of those trained 
have returned to their countries. TDR has developed new packages, such 
as a Fever Package that can be administered within households, or the 
Sick Child Package, that integrates treatment of children with fever 
that will prevent deaths from severe malaria, pneumonia and meningitis, 
and a package for removing the burden of helminths (worms) that afflict 
school children and retards their growth and academic performance, but 
they do not have the resources even to test them on a sufficient scale 
in developing countries.
    I would like to emphasize the work that the new United Nations 
Program on HIV/AIDS (UNAIDS) is helping to address the greatest 
infectious disease challenge in this era. UNAIDS was established in 
1996 to bring together the efforts of six UN agencies and The World 
Bank in a common effort to address the international response to HIV/
AIDS:, including the United Nations Children's Fund (UNICEF), United 
Nations Development Program (UNDP), United Nations Population Fund 
(UNFP), United Nations Education, Scientific and Cultural Organization 
(UNESCO) and the World Health Organization (WHO). Although only two 
years old, UNAIDS has made a significant impact in disease prevention, 
policy development and public-private sector partnerships. There is 
encouraging evidence that well defined prevention efforts can lead to 
substantial progress in reducing HIV transmission. Declines in HIV 
prevalence in military recruits in Thailand and among pregnant women in 
Uganda indicates that with a well designed and organized program can 
achieve significant progress in reducing HIV infection and 
transmission. UNAIDS work in Vietnam, Ukraine and Pakistan has 
encouraged these governments to undertake large scale AIDS prevention 
programs, and UNAIDS has helped national partners to plan and carry-out 
programs to improve blood supply safety and institute medical care for 
curable sexually transmitted diseases. Because of increased awareness 
generated by UNAIDS efforts, some major companies in the private sector 
are working to protect and educate their work forces, especially in 
emerging markets. Shell Oil for example is assisting the Botswana 
national HIV/AIDS educational program, Levi Strauss is working on a 
major AIDS education program for supplying communities in Southeast 
Asia.
    The Global Program on Tuberculosis at WHO has introduced directly 
observed therapy (DOTS) into China, Bangladesh and several countries in 
Latin America with dramatic results. Reported cure rates have been over 
85 percent, and transmitting the design and operation of such programs 
is strengthening the healthcare infrastructures in those countries in a 
sustainable way. Without such carefully designed programs drug 
resistance will increase. Because of the cost-effectiveness of 
prevention through immunization, the GTB has a major need for increased 
resources in strengthening the longer term effort to develop and test 
vaccines that can prevent infection or disease.
    Finally, vaccines represent the most cost-effective known medical 
intervention to prevent disease and death. In the United States, we 
save $32 million every 20 days by not having to vaccinate against 
smallpox [3]. For every dollar invested in measles, mumps and rubella, 
$2 dollars is saved in direct and indirect medical costs. For 
diphtheria, whooping cough and tetanus, that savings is $29 dollars for 
each dollar expended. We know from the Global Programme on Vaccines 
deriving from the Expanded Program for Immunization at WHO/UNICEF, that 
vaccines can be delivered to children in virtually every corner of the 
world. In 1975 fewer than 15 percent of the world's children received 
their childhood vaccines. In 1996 83 percent of the world's children 
have received childhood immunizations, resulting in the saving of at 
least 4.6 million lives. Thanks to partnership of WHO, UNICEF and the 
Pan American Health Organization with Rotary International in effecting 
polio vaccination in Latin America, the most astonishing result is that 
there have been no cases of paralytic poliomyelitis reported in the 
entire Western Hemisphere in the past four years. The next target is 
the global elimination of polio and initiating a comparable attack on 
measles.
 why should the united states take a more active role in global health?
    The Board on International health of the Institute of Medicine of 
the National Academy of Sciences has, over the past year and a half, 
examined the role of United States in international health [3]. It 
recommended strongly that it was in America's vital interests to engage 
more actively in global health activities. In this context, global 
health is defined as ``health problems, issues and concerns that 
transcend national boundaries and may best be addressed by cooperative 
actions''. The Board presented four sets of arguments to support its 
recommendation: (i) To fulfill a genuine humanitarian tradition; (ii) 
to protect our people; (iii) to enhance our economy; and (iv) to 
advance our international interests. A number of recent polls, [4] [5] 
have indicated that there is greater than generally perceived public 
support for international health and overseas humanitarian assistance 
provided, that it goes to those most in need, and accomplishes what it 
is intended to do. Those same polls reveal, on the other hand, 
widespread misperceptions among the public that the United States is 
spending a great deal more on foreign aid than is the case. For 
example, the majority of respondents believed the federal government 
was spending more on foreign aid (1 percent of the budget) than on 
Medicaid (13 percent of the budget). When informed of the true 
circumstance, most favored spending more in foreign assistance that is 
the current state. In fact, of the 20 OEDC countries, the United States 
ranks last in percentage of gross domestic product expended on foreign 
aid, and fourth in the absolute dollar amount [6]. In the global 
context, support for foreign assistance has declined for the past 
several years, declining from about $83 million to about $71 million 
from 1993 to 1993 [1]. Of total foreign aid funds, only about 10 
percent is spent on health. The Board on International Health report 
argues that with the enormously rapid globalization of trade and 
commerce, there is a globalization of risks [3] [7]. Currently, there 
are 23 million international travelers each year; 2 million people move 
across national boundaries each month. There are 45 million refugees 
who are dislocated from their countries or homes, and 70 countries have 
more than 70,000 refugees. Over 120 million people live outside their 
country of birth, and 70 million people work legally or illegally in 
other countries. The impact of this new circumstance is increasing 
health risks of transfer of infectious agents for both human and animal 
diseases, increased risk of epidemics and outbreaks because of 
urbanization and crowding, increased risks through transport and 
traffic in toxic substances, including drugs, pesticides, pollutants 
and tobacco. And there is the risk of biological and chemical 
terrorism.
    In fulfilling the government's responsibility to protect our 
people, the Board believed that the U.S. must be more active in 
supporting a global network for infectious disease surveillance, and in 
protecting against existing and emergent infectious diseases in humans 
and in animals. Perhaps one example of the actual historical impact of 
the influenza epidemic of 1918 will serve to indicate the potential 
threat we face from evolutionary or terrorist induced emergence of 
infectious disease.

Table 5.--The dynamics of a global epidemic: Influenza, 1919

                                                                   Cases
Camp Devens, MA:
    September 12..................................................     1
    September 18.................................................. 6,674
    September 23 (727 deaths).....................................12,604

    Note.--In the United States: 25 percent of the civilian population 
infected in 2 years. The fatality rate was 4,000/100,000.
    Globally: In 6 months there were 40,000,000 deaths. (In contrast, 
in the 4 years of World War I, there were 15 million deaths).

    This can clearly best be done by supporting the WHO Emerging 
Infections Program and enabling it to develop a useful global 
surveillance system for early warning of new and drug resistant 
infectious pathogens.
    In the interest of protecting our people, another reason must be 
considered for the United States to be actively engaged in 
international health activity. Because of unique opportunities abroad 
for gaining medical knowledge or testing new interventions, for example 
for testing vaccines against pertussis in Scandinavia, or against 
malaria in Africa or AIDS in Thailand, the United States can obtaining 
greater value-for-money by trials abroad where the incidence rates of 
disease are greater and the time required to obtain a statistically 
significant endpoint are greater. In perhaps the most pressing case, 
AIDS, most experts in the field agree that, at a time when we do not 
yet know how effective the new and expensive drugs will be against HIV 
in this country, or whether resistance will emerge to them, it is 
essential to develop vaccines, even with significantly lower protective 
efficacy than we are accustomed to in measles or polio vaccines, to 
combat HIV and AIDS. It is my professional judgment that, because of 
the ethical need to offer any individuals in this country who show 
evidence of HIV in the blood the opportunity for combined drug therapy, 
it is no longer possible to carry out meaningful clinical trials to 
determine the efficacy trials of candidate HIV vaccines in the United 
States. Hence we are all dependent for such knowledge enhancing the 
health and scientific infrastructure in disease endemic countries.
    The third set of reasons the Board on International Health adduced 
to support increased engagement in global health was its importance to 
enhancing our economy. The global health market itself represents $1.7 
trillion, that is the equivalent of 8 percent of the entire world 
economic output. The global pharmaceutical and medical device markets 
represented in 1992 over $220 billion in drugs and $71 billion in 
devices [8]. Of that, $44 billion was sold in developing countries. 
Despite the fact the U.S. creates more new patents for new drugs and 
devices, the European Union had 73 percent of drug exports in 
developing countries in 1992. Clearly there are economic and regulatory 
barriers to allowing American pharmaceutical and vaccine and medical 
device industries to gain access to emerging and developing markets, 
and more importantly, preventing the people of developing countries to 
obtain access to lifesaving drugs at a price that can be afforded. 
There are currently 2 billion people who do not have access to 
essential drugs. Social and economic studies by WHO-TDR and others in 
Africa have indicated that mothers of children with malaria spend up to 
30 percent of their annual disposable income for treatments of their 
child's illness, yet fewer than half of the treatments purchased would 
be expected, on medical grounds, to provide any benefit whatsoever. 
There are major economic constraints that need to be addressed.
    Finally, the Board believes that U.S. engagement in global health 
provides an important opportunity to advance the United States global 
interests. The United States is by any standard the world's leader in 
science and technology, and produces more knowledge, publications, and 
new medical interventions than any other country in the world. We need 
to provide more resources to train the leadership in health in 
developing countries, to enable the development of health 
infrastructures to make a significant contribution to improving the 
quality of lives of people in developing countries, and that will take 
continued commitment and support. Despite our scientific and technical 
expertise, multiple agencies within the government have statutory 
responsibilities for aspects of international health, and there is no 
coherent strategy or obvious focus leadership within the United States 
government. The Board on International Health recommended an inter-
government agency task force, given the limited and scarce resources 
available for global health, to coordinate and focus the activities of 
each of the agencies in a more coordinated and effective fashion. In 
addition, because the problems in global health are likely to be more 
technically and scientifically demanding, and because of the strengths 
of the National Institutes of Health and the Centers for Disease 
Control within DHHS, the Board recommended further that authorization 
and support be provided to DHHS for new initiatives in global health 
and coordination between academic institutions, industry, NGO's and 
international organizations such as WHO. In this context, the Board 
recommended undertaking a significant effort to establish global 
surveillance for infectious diseases. Finally, the Board argued that it 
is very difficult for the U.S. to exert the global leadership in health 
that it could, or even to be taken seriously as a leader in global 
health within international organizations, if the United States was 
hundreds of millions of dollars in arrears in its treaty-obligations to 
the World Health Organization and the United Nations system in general. 
Because of our leadership in medical science and technology, the United 
States has an important opportunity to influence the international 
community, international organizations and developing and 
industrialized countries alike to address the health problems of those 
most in need. Greater U.S. engagement would serve both the global 
health needs, and our own our enlightened self-interest. As the poet 
John Donne long ago wrote,

``No man is an iland, entire of itselfe.
Every man is a piece of the continent, a part of the maine * * *.
Any man's death diminishes me,
Because I am involved in Mankind.''
                               References
    [1] World Bank, 1993. World Development Report: Investing in 
Health, New York. Oxford University Press.
    [2] WHO. Investing in Health Research and Development. Report of 
the Ad Hoc Committee on Health Research Relating to Future Intervention 
Options. Geneva. World Health Organization, 1996.
    [3] Institute of Medicine. 1997. America's Vital Interest in Global 
Health, Washington, DC. National Academy Press.
    [4] CSPA (Center for the Study of Policy Attitudes). 1995. 
Americans and Foreign Aid: A Study of American Public Attitudes. 
Baltimore. University of Maryland.
    [5] The Washington Post, Kaiser Family Foundation, and Harvard 
University. 1996. Reality Check: The Politics of Mistrust. Why Don't 
Americans Trust the Government. The Washington Post, 29 January, 4 
February, 1996.
    [6] OECD (Organization for Economic Cooperation and Development). 
1996. New Release 11 June, 1196, Paris: OECD Communications Division.
    [7] Wilson, M.E. Travel and the emergence of infectious diseases. 
Emerg. Infec. Dis. 1:39-45, 1995.
    [8] Ballance, R. Pogany, J. and Forstner, H. The World's 
Pharmaceutical Industries. An International Perspective on Innovation, 
Competition and Policy. Prepared for the United Nations Industrial 
Development Organization (UNIDO). United Kingdom. Edward Elgar. 1992.
STATEMENT OF DAVID HEYMANN, M.D., DIRECTOR, DIVISION OF 
            EMERGING AND OTHER COMMUNICABLE DISEASES 
            SURVEILLANCE AND CONTROL, WORLD HEALTH 
            ORGANIZATION
    Senator McConnell. Dr. Heymann.
    Dr. Heymann. Thank you, Mr. Chairman and Senator Leahy. WHO 
appreciates the opportunity to provide information to the 
committee on the critical importance of strengthening 
international cooperation and participation in the surveillance 
and control of communicable diseases.
    In my written statement I have laid out the details of the 
global framework for surveillance and control of communicable 
diseases. WHO, at the request of its 191 member countries, is 
putting this framework in place. Many partners are involved in 
this effort--countries, international organizations, business 
and industry, national nongovernmental organizations, 
scientific laboratories, research institutions, universities, 
and the monitoring group of the Biological Warfare Convention.
    Page 2 of my written statement outlines four major areas 
which are top priority for worldwide attention. They are: 
strong national infectious diseases surveillance and control; 
global monitoring and alert systems with electronic access to 
the WHO information highways on infectious diseases; and 
international preparedness.
    This first chart shows you that in 1996, just a 12-month 
period, 27 infectious diseases outbreaks have added to the 
heavy burden of underlying diseases, such as malaria, diarrhea, 
respiratory disease, and AIDS. Some of these diseases create 
ominous associations, such as TB, which is facilitated by HIV. 
Others suggest that infectious agents can effectively jump the 
species barrier from animal to man, such as is the case of BSE, 
or mad cow disease, in the United Kingdom.
    Over one-half million cases of dengue, a viral disease 
carried by mosquitoes, have been reported from Latin America 
during the past 2 years. During 1996, a tourist to Latin 
America returned to Tennessee with yellow fever. There have 
been an average of 954 imported cases of malaria each year, 
some of which have taken up residence in U.S. mosquito 
populations and been transmitted to persons who have never 
traveled internationally.
    This next chart shows you the distribution of malaria in 
the United States 50 years ago. Malaria was eradicated from the 
United States in the 1950's and 1960's, but mosquitoes that can 
carry malaria and mosquitoes that can also carry dengue and 
yellow fever remain. They move north to the great metropolitan 
areas in the summer.
    Strong surveillance and control of dengue, yellow fever, 
and malaria in developing countries where they are occurring 
will lead to prevention and containment where they occur.
    The next chart shows you cholera, which is on the increase 
throughout the world, but as you can see in the green bars, 
mostly in Latin America. Over 1.4 million cases of cholera have 
been reported from Latin America since 1991. Up to 10 percent 
of those who develop cholera died in some areas.
    Cholera costs countries in human suffering and death, in 
patient care, in lost economic output, and in trade sanctions. 
Peru just $770 million in 1991 because of bans of its seafood 
exports because cholera had been imported to the country.
    Cholera could have posed a real threat to the United States 
if unsuspecting authorities had not been alerted by information 
from WHO and if WHO through its Baja regional office had not 
worked intensively with Latin American countries to stop the 
spread.
    The next chart reminds us that international travel spreads 
infectious diseases. It also spreads microorganisms that have 
developed resistance to antibiotics. Strains of the bacteria 
that cause common pneumonia resist both old and new 
antibiotics. In the early 1990's, during a period of weeks 
multiresistant streptococcus pneumoniae, shown on this chart, 
spread from Spain throughout the world. Man, like the mosquito, 
is a vector of infectious diseases.
    Antibiotic resistance spreads rapidly. Death occurs when 
antibiotics no longer work effectively and costs for treating 
patients increase.
    WHO works with developing countries to ensure that 
antibiotic resistance is tracked, that prescribing practices 
are correct, and that resistant organisms are contained at 
their source.
    This chart shows you the new WHO network of laboratories 
for monitoring antibiotic resistance, which helps countries 
develop effective treatment policies. Last year eight 
developing countries in Asia and in Africa were brought into 
the system, with support from Japan, the United States 
Pharmaceutical Research and Manufacturers Association, which 
supported activities in Africa, and CDC.
    The network must be expanded to other developing countries 
in Africa and Latin America, to both human and veterinary 
laboratories, and linked electronically to industrialized 
country networks.
    This chart shows you the WHO network for monitoring 
influenza. Laboratories are located throughout the world. Each 
year information from this network is provided to the 
pharmaceutical industry for development of vaccines which 
prevent influenza the following year in our aging populations. 
This network must be expanded, especially in southern China, 
where new influenza viruses frequently jump the gap between 
animals and humans and cause epidemics such as Dr. Bloom 
described in 1918, when at least 20 million people were killed 
from influenza.
    This chart shows the WHO laboratory network for monitoring 
and alert of bacterial, viral, and veterinary diseases. These 
are strong national laboratories that collaborate with WHO and 
use WHO norms to ensure early detection of infectious diseases 
in those countries and regions. Information from these 
laboratories is used nationally and provided directly to WHO. 
The network must be expanded to more developing countries, 
especially in Africa and Latin America, and linked 
electronically.

                           prepared statement

    Finally, I would just like to go back to the first chart 
again, to remind you that infectious diseases occur throughout 
the world. They are increasing because of weakened public 
health infrastructure and are linked to behavior, 
deforestation, climate change, and social upheaval. It is in 
the interest of the world community to strengthen WHO's 
programs to strengthen national capacity to detect and control 
infectious diseases so that we can ensure their containment 
where they are occurring. And it is in the interest of the 
world community to expand WHO's existing infectious diseases 
monitoring networks and electronic information systems.
    United States support could make the decisive difference in 
how rapidly and how well the job is done.
    Thank you very much.
    Senator McConnell. Thank you Dr. Heymann.
    [The statement follows:]
              Prepared Statement of David L. Heymann, M.D.
    Mission: To strengthen national and international capacity in the 
surveillance and control of communicable (infectious) diseases, 
including those that represent new, emerging and re-emerging public 
health problems.
        the changing picture of infectious diseases: the problem
    Few public health concerns today carry as much sense of urgency and 
importance as emerging and re-emerging communicable (infectious) 
diseases. Many factors contribute to these diseases, including 
population growth, migration, urbanization and poverty compounded by 
inadequate or deteriorating public health infrastructures for disease 
control. Changes in human behaviour and alteration in land use, 
agricultural practices, climate and environmental conditions contribute 
to increased exposure to and spread of infectious disease agents. 
Humans, through world travel and trade unprecedented in history, have 
themselves become a principal vector of infectious diseases, 
transporting them easily from one country to another within periods 
less than 24 hours. Fresh concerns have arisen about the ability of 
infectious agents of animal origin to cross the species barrier from 
animal to man. Not least, resistance of microorganisms to the drugs 
used to combat them and resistance of vectors to pesticides used to 
control them have profound implications for our ability to deal 
effectively with infectious diseases. Resistance threatens the very 
base of infectious disease control. Furthermore, infectious diseases 
can have many sources, from natural human or animal occurrences due to 
the changing world environment just described to potentially 
intentional release of pathogens with the objective of harming human 
health or the health of animals and plants on which humans depend.
    The urgency and importance for public health of emerging and re-
emerging infectious diseases create an urgent need to monitor the 
situation nationally and globally and to respond in a rapid and 
effective manner. Effective monitoring and response can only be ensured 
by international collaboration and the solidarity of many different 
partners ranging from countries and international organizations to non-
governmental organizations, business and industry, government and 
private public health and laboratory systems, and universities.
    global framework for communicable disease control: the response
    The World Health Organization is uniquely capable of putting in 
place a truly global framework for communicable disease surveillance 
and control activities because of its universal membership of 191 
Member States. As the Specialized Agency of the United Nations system 
with responsibility for the direction and coordination of international 
health work, its Member States have requested WHO to coordinate 
intensified efforts to improve global surveillance and control, 
especially for the newly emerging, re-emerging and other communicable 
diseases.
    WHO has identified many partners with the same vision, and its 
strategy is to work with these partners within a cooperative global 
framework to reshape and strengthen national and international networks 
for infectious disease surveillance and control. Laboratory-based 
surveillance, international communication networks, national 
surveillance systems and a strong national and international public 
health infrastructure form the basis of this strategy. Areas of 
concentration are:
  --Global monitoring and alert systems to bring together laboratories 
        and disease surveillance systems from all countries to share 
        information through electronic and printed media;
  --Global information systems to ensure that information collected 
        through global monitoring and alert can be rapidly and widely 
        disseminated;
  --Strong national surveillance and control to detect and decrease or 
        eliminate infectious diseases; and
  --International preparedness to provide strong, coordinated and 
        engaged response at the international level to provide the 
        environment necessary for countries to improve their 
        surveillance and control capacities.
                  global monitoring and alert systems
    Five global monitoring and alert systems are being strengthened by 
WHO:
    The International Health Regulations (IHR) are the only 
international public health legislation which requires mandatory 
reporting of infectious diseases. Currently the IHR cover cholera, 
plague and yellow fever, though countries often refuse to report these 
diseases because of the resulting negative impacts on trade and 
tourism. Under the direction of the World Health Assembly, and in order 
that the IHR may serve as a working global alert system, WHO is 
revising them to make them more effective and comprehensive. Through 
electronic links with quarantine officers in the 191 WHO member 
countries the system will become proactive, providing immediate reports 
of disease and syndrome outbreaks of international importance and 
permitting timely provision of recommendations on what measures should 
and should not be taken in response.
    WHO Collaborating Centers on communicable and zoonotic diseases 
already comprise more than 200 institutions worldwide--mainly human and 
veterinary microbiological laboratories. These laboratories are centers 
of excellence which provide reference services for verifying the 
diagnosis of bacterial, viral and zoonotic diseases and/or training or 
epidemiological services for WHO Member States. Linking all Centers 
electronically will ensure regular exchange of information on 
infectious diseases and permit timely identification of problems and 
needs so that the necessary training, supplies and/or reagents may be 
provided. Information from this system is regularly used to update the 
WHO World Wide Web site at . Current efforts are 
underway to widen the geographic coverage of the network of WHO 
Collaborating Centers to include more developing country laboratories. 
Additional military laboratories are also being solicited to join the 
WHO networks.
    Antimicrobial Resistance Monitoring Networks are an expanding group 
of medical and veterinary laboratory centers which perform antibiotic 
sensitivity testing on bacteria which cause diseases ranging from 
gonorrhea and other sexually transmitted diseases to tuberculosis. The 
national data are used for antimicrobial policy formulation and feed 
electronically into the WHO regional and global networks for monitoring 
of drug resistance and into geographical displays on the World Wide Web 
site. Expansion of these networks in developing countries is currently 
underway.
    WHO Rumour/Disease Outbreak List contains unconfirmed rumours of 
communicable and zoonotic disease outbreaks worldwide, which are 
received from various sources outside of WHO. This ``rumour'' list is 
distributed electronically to key public health policy makers in each 
country and to UN agency and NGO collaborators to consider relevant 
policy implications prior to actual confirmed reporting of those 
diseases by countries. Once confirmation is received, it is published 
on the WHO World Wide Web site.
    Other Active Global Surveillance Systems which collect information 
for action include the influenza network, which collects information 
from more than 130 participating laboratories worldwide that is used to 
make a decision on influenza vaccine composition for the following 
year, and the HIV/AIDS network, which provides information from more 
than 90 sentinel sites that is used to monitor the AIDS situation 
worldwide. The influenza network is the first of these active systems 
to go online with direct electronic data entry by participants, and 
with global access via the WHO World Wide Web site for queries to the 
database and for the generation of comparative charts and maps. WHO is 
in the process of building other global disease databases similar to 
this influenza prototype.
    To strengthen sites participating in these five systems and to 
expand them to those developing countries which are not yet 
incorporated WHO and its partners will need to provide intensive 
training and some basic laboratory equipment and supplies.
                       global information access
    Developments in electronic communications in recent years have 
enhanced national public health surveillance systems and enabled 
revolutionary progress in surveillance that crosses national 
boundaries. WHO is paving the way in international surveillance by 
using communication networks to facilitate rapid collection and 
analysis of data using standardized case definitions, transmission of 
information for the prevention of communicable diseases, and promotion 
of effective public health practice.
    WHO provides a focal point for global data and information 
exchange. It is working to ensure the timely worldwide dissemination of 
information obtained from its monitoring and alert systems and other 
information relevant to infectious diseases through the Weekly 
Epidemiological Record, WHO publications, the Internet's World Wide 
Web, and other media available to the program. WHO is focused above all 
on the value of the information being delivered--its quality, accuracy, 
relevance and reliability. Electronic communications can make that 
information available at any time and place.
    The participants of the WHO monitoring and alert systems have been 
targeted by WHO as priority sites for electronic linkages. Electronic 
linkages under the WHO Global Information Access project are being 
developed within the framework of a joint WHO/UNAIDS/World Bank project 
which will also link other sites for information exchange. These other 
sites include the WHO country representatives, the country/regional 
representatives of the UNAIDS program, and the World Bank's projects in 
health.
    To provide electronic linkage for the developing country sites, 
computer software and in some instances hardware, along with 
connectivity to the Internet, are required.
                strong national surveillance and control
    Strong national surveillance systems are at the heart of national 
infectious disease control programs. Relevant, accurate and timely 
information permits action that decreases or eliminates infectious 
diseases, can avert a local or national outbreak, and at the same time 
prevent a crisis at the international level. Strong surveillance and 
control systems in countries help to identify areas of high risk for 
infectious disease, guide immunization and other prevention strategies, 
and detect and control the re-emergence of infectious diseases. To 
strengthen the national infrastructure in order to recognize, report 
and respond to infectious diseases, WHO provides technical guidance 
using international consensus policies on surveillance and control 
strategies, facilitates activities of governments and non-governmental 
organizations to train epidemiologists and public health specialists, 
provides minimal support for supplies and equipment, and advocates for 
government support of these efforts.
    To strengthen national infectious disease surveillance and control, 
WHO and its partners will need to supply routine national, regional and 
interregional training of trainers and provision of minimal supporting 
infrastructure.
                       international preparedness
    International preparedness requires a concerted effort to ensure 
that various resources and necessities for communicable disease 
surveillance and control are available and adequately operationalized. 
This includes ensuring that vaccines, drugs and other supplies 
necessary to prevent or treat infectious diseases are available in 
sufficient quantity at the international level. It also requires that 
expert advice is available when and where needed, and that operational 
research continues to identify and operationalize the most efficient 
and cost-effective disease surveillance and control strategies. At 
times, international preparedness also involves provision of WHO staff 
and international partners to work with national health authorities at 
the time of epidemics and immediately afterwards in control activities 
and in developing plans to prevent future occurrences.
    To ensure international preparedness, normative activities such as 
support for priority operational research and development of 
international consensus strategies for surveillance and control, 
laboratory norms and diagnosis must be continued by WHO. In addition, 
through continued dialogue and meetings with representatives of the 
pharmaceutical and other medical supply industries, issues concerning 
availability of drugs, vaccines, and diagnostic tests must be 
addressed.
                a role for the united states of america
    If the world is to respond effectively to emerging and re-emerging 
infectious diseases we must do so locally, nationally and 
internationally. Whether we are dealing with the complexities of 
establishing national surveillance and effective disease control, or 
are in the front lines of a response to an outbreak, we need good 
laboratory facilities and technicians, people well trained in 
epidemiology and disease control, and solid and reliable communication 
networks. We must rebuild the infrastructure of public health, and 
continue to support it internationally.
    Despite gains made in recent decades, many national surveillance 
and control programs are still fragile. The world will continue to 
battle against infectious diseases for years to come and the costs of 
inaction are high. The challenge will be to find the balance of 
resources that will preserve and build on what has been accomplished by 
WHO and its Member countries and partners. The global framework for 
surveillance and control of infectious diseases which WHO is putting in 
place will ensure cost-effective and non-duplicative investment in 
developing countries in order to rebuild and strengthen capacity to 
detect and control infectious diseases. The United States has been one 
of WHO's important partners in infectious diseases surveillance and 
control, including the global eradication of smallpox in the 1970s and 
polio eradication in the 1990s. To tackle the newest challenges in 
infectious disease surveillance and control successfully, WHO and the 
developing countries will need the United States to continue its 
support to form even stronger links in its partnership with WHO. The 
report of the National Science and Technology Council Committee on 
International Science, Engineering, and Technology (CISET) Working 
Group on Emerging and Re-emerging Infectious Diseases has documented 
why it is in the vital interest of the United States to contribute to 
WHO's activities to strengthen disease detection and containment in 
developing countries. Such an investment will further decrease the risk 
of the international spread of infectious diseases and antimicrobial 
resistance and the associated costs for every nation.
                                 ______
                                 
    Forty-Eighth World Health Assembly--Agenda Item 19--May 12, 1995
  communicable diseases prevention and control: new, emerging, and re-
                      emerging infectious diseases
    The Forty-eighth World Health Assembly, having considered the 
report of the Director-General on new, emerging, and re-emerging 
infectious diseases; \1\
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    \1\ Document A48/15.
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    Recalling resolutions WHA39.27 on rational use of drugs, WHA44.8 
and WHA46.36 on tuberculosis, WHA45.35 on human immunodeficiency virus, 
WHA46.31 on dengue prevention and control, WHA46.32 on malaria, and 
WHA46.6 on emergency and humanitarian relief;
    Aware that with the increasing global population many are forced to 
live under conditions of overcrowding, inadequate housing, and poor 
hygiene; that more frequent international travel leads to rapid global 
exchange of human pathogens; that changes in health technology and food 
production, as well as its distribution (including international trade) 
and handling, create new opportunities for human pathogens; that human 
behavioural changes expose large segments of the global population to 
diseases not previously experienced; that expanding areas of human 
habitation expose thousands of people to enzootic pathogens previously 
unknown as causes of human disease; and that microbes continue to 
evolve and adapt to their environment, leading to the appearance of new 
pathogens;
    Aware also of the continued threat of well-known diseases such as 
influenza and meningococcal infections, and of tuberculosis, cholera 
and plague, once thought to be conquered, and the growing danger of 
diseases transmitted by vectors no longer controlled, such as dengue 
haemorrhagic fever and yellow fever;
    Concerned at the lack of coordinated global surveillance to 
monitor, report and respond to new, emerging, and re-emerging 
infectious diseases, by the general absence of the diagnostic 
capabilities necessary to identify accurately pathogenic microorganisms 
and the insufficient numbers of trained health care professionals to 
investigate these infectious diseases;
    Alarmed by the increasing frequency of antimicrobial resistance in 
bacterial pathogens, which can make some diseases such as tuberculosis 
virtually untreatable with currently available antibiotics,
    1. URGES Member States:
  --(1) to strengthen national and local programmes of active 
        surveillance for infectious diseases, ensuring that efforts are 
        directed to early detection of outbreaks and prompt 
        identification of new, emerging and re-emerging infectious 
        diseases;
  --(2) to improve routine diagnostic capabilities for common microbial 
        pathogens so that outbreaks due to infectious diseases may be 
        more easily identified and accurately diagnosed;
  --(3) to enhance, and to participate actively in, communications 
        between national and international services involved in disease 
        detection, early notification, surveillance, control and 
        response;
  --(4) to encourage routine testing of antimicrobial sensitivity, and 
        to foster practices for rational prescription, availability and 
        administration of antimicrobial agents in order to limit the 
        development of resistance in microbial pathogens;
  --(5) to increase the number of staff skilled in both epidemiological 
        and laboratory investigations of infectious diseases and 
        promotion in such specialization;
  --(6) to foster more applied research in areas such as the 
        development of sensitive, specific and inexpensive diagnostics, 
        the setting of standards for basic public health procedures, 
        and the establishment of fundamental disease prevention 
        strategies;
  --(7) to control outbreaks and promote accurate and timely reporting 
        of cases at national and international levels;
    2. Urges other specialized agencies and organizations of the United 
Nations system, bilateral development agencies, nongovernmental 
organizations and other groups concerned to increase their cooperation 
in the recognition, prevention and control of new, emerging and re-
emerging infectious diseases both through continued support for general 
social and health development and through specific support to national 
and international programmes to recognize and respond to new, emerging, 
and re-emerging infectious diseases;
    3. Requests the Director-General:
  --(1) to establish, in consultation with Member States, strategies to 
        improve recognition and response to new, emerging and re-
        emerging infectious diseases in a manner sustainable by all 
        countries and prompt dissemination of relevant information 
        among all Member States;
  --(2) to draw up plans for improved national and international 
        surveillance of infectious diseases and their causative agents, 
        including accurate laboratory diagnosis and prompt 
        dissemination of case definition, surveillance information, and 
        to coordinate their implementation among interested Member 
        States, agencies and other groups;
  --(3) to increase WHO's capacity, within available resources, for 
        directing and strengthening applied research for the prevention 
        and control of these diseases, and to ensure that reference 
        facilities remain available for safely characterizing new or 
        unusual pathogens;
  --(4) to establish strategies enabling rapid national and 
        international responses to investigate and to combat infectious 
        disease outbreaks and epidemics including identifying available 
        sources of diagnostic, preventive and therapeutic products 
        meeting relevant international standards. Such strategies 
        should involve active cooperation and coordination among 
        pertinent organizational programmes and activities including 
        those of the Global Programme for Vaccines, the Action 
        Programme on Essential Drugs, and the Division of Drug 
        Management and Policy;
  --(5) to coordinate WHO's initiative on new, emerging and re-emerging 
        infectious diseases in cooperation with other specialized 
        agencies and organizations of the United Nations system, 
        bilateral development agencies, nongovernmental organizations, 
        Member States, and other groups concerned;
  --(6) to improve programme monitoring and evaluation at national, 
        regional and global levels;
  --(7) to keep the Executive Board and the Health Assembly informed of 
        progress in the implementation of this resolution.
STATEMENT OF NILS DAULAIRE, M.D., CHIEF HEALTH POLICY 
            ADVISOR, U.S. AGENCY FOR INTERNATIONAL 
            DEVELOPMENT
ACCOMPANIED BY DENIS CARROLL, M.D., AID

                          infectious diseases

    Senator McConnell. Would you help me with the pronunciation 
of your name?
    Dr. Daulaire. Doctor ``DeLare.''
    Dr. Heymann. ``DeLare.'' Dr. Daulaire, you are up.
    Dr. Daulaire. Thank you. I appreciate the opportunity, 
Senator McConnell and Senator Leahy. This is an exciting day 
for those of us who have devoted our professional careers to 
addressing the issues of infectious diseases.
    From my own personal training as a family physician and 
subsequently as a public health specialist, I learned that the 
best way to ensure good health is not simply to treat the 
symptoms of illness, but to systematically address the 
underlying causes. Today we call this wellness, and prevention 
is at its core.
    We all recognize infectious diseases as a very serious 
problem, causing 17 million deaths per year and hundreds of 
millions of new infections. We can respond by chasing endlessly 
after the symptoms of this disease--outbreaks of ebola in 
Africa, of plague in Asia, of dengue fever in Latin America, 
diphtheria in the former Soviet Union--or we can help the 
international community in surveillance and response, as my 
colleague Dr. Heymann has just been describing, but focus 
ourselves on prevention, on addressing the root causes for the 
spread of infectious diseases.
    It is my professional judgment that the latter approach is 
the best investment we can make in global health and a vital 
role for the United States. Therefore, the Agency for 
International Development's approach consists of four closely 
linked elements. I will describe them briefly.
    First, basic prevention through changing conditions that 
allow infectious diseases to flourish and spread;
    Second, secondary prevention through improving health 
systems in developing countries so they are themselves able to 
prevent and control infectious diseases within their borders;
    Third, targeted disease-specific prevention and control 
efforts focused on priority diseases; and
    Fourth, response to emergency situations.
    That is an intentional ordering.
    In terms of basic prevention, the 1992 report of the 
Institute of Medicine on emerging infections, which was really 
a seminal work for much of what we do here, cited six 
underlying factors responsible for the spread of infectious 
diseases. Most of these factors cited in the Institute of 
Medicine report are addressed not by health interventions, but 
by development.
    For instance, they talked about crowded megaslums which are 
the ideal breeding ground for infectious diseases. We address 
these through programs aimed at poverty reduction and at 
slowing explosive population growth. They talked about the 
undernourished, especially children, who have far lower 
resistance to disease and, therefore, serve as incubators, if 
you will, and spreaders of infection. We address these through 
programs aimed at improved nutrition and food security. They 
talked about polluted waters and unchecked breeding sites for 
mosquito vectors of disease that are the highways, if you will, 
of disease transmission. We address these through our 
environmental programs.
    The Institute of Medicine also cited the breakdown of 
public health measures as a fundamental cause for the spread of 
infectious diseases. We all recognize that countries must be 
able to provide their own first line of defense, what Dr. Bloom 
referred to as self-reliance. Therefore, our focus on the 
second part of the four-part strategy I talked about, secondary 
prevention, is aimed at rebuilding and strengthening the 
fragile health systems of developing countries so they can be 
run and managed by their own people.
    At AID we focus our efforts on the fundamental building 
blocks of health systems--training, supervision systems, drug 
supply and logistics, information systems, communications, and 
budget and finance. These may seem sometimes arcane, but they 
are the basic blocks that will allow all countries to 
systematically protect their own people against infectious 
diseases threats and, thereby, serve as the first line of 
defense for our own country.
    Third, far from neglecting targeted disease-specific 
prevention and control programs, these have in fact over the 
past several years constituted the core of AID's health 
programs. In fact, in 1996 approximately $320 million to 
activities directly addressing infectious diseases of major 
public health importance. I think that is a fact that is not 
often recognized, the degree of our investment. And in fact, 
this is far greater than any other bilateral donor.
    These efforts were principally encompassed within two 
groups of activities, child survival and HIV-AIDS. As you are 
aware and as has been cited earlier, most of the world's 
infectious diseases deaths occur among children. Pneumonia and 
diarrhea lead the list, and we have active and effective 
programs in these areas.
    Malaria kills mostly children. It is estimated about 85 
percent of all deaths, as you mentioned yourself, Senator 
McConnell, from malaria are among children. And this has been 
increasingly incorporated into our child survival programs.
    We are also addressing the threat discussed a few moments 
ago of antibiotic resistance through these programs, 
particularly our pneumonia control programs, where timely and 
appropriate treatment with antibiotics is the key to effective 
solutions.
    I would also mention, Senator McConnell, from your own 
experience that starting in the early 1980's AID pioneered the 
efforts in the Western Hemisphere to eradicate polio. In fact, 
I think we gave the very first grant to Rotary International 
that got them into this, which I think was probably the very 
best public health investment we have ever made.
    Of course, since the 1980's we have also led the world in 
programs to address AIDS in the developing world. As we heard, 
AIDS is one of the truly emerging disease threats of the world.
    Finally, while we recognize--and I mentioned the first 
three factors, the first three activities--we recognize that 
you do not want to start a health care system by building 
emergency rooms, we do recognize that you have to have 
emergency response. And we have been actively involved in a 
system with response to outbreaks, such as the ebola outbreak 
in Zaire, where I believe we were the principal funder of the 
immediate response.
    Now, that leaves two important issues that were discussed 
earlier, malaria and tuberculosis. I have mentioned malaria. We 
have invested over the years--and I was quite surprised when I 
saw these figures myself--over $1 billion in malaria prevention 
and control. In recent years we focused our efforts on malaria 
vaccine development, something we call the Africa integrated 
malaria initiative, and incorporating malaria treatment into an 
integrated case management of childhood illness, which is at 
the heart of our child survival program.
    Finally, TB. TB remains a major challenge, and we have 
focused the resources we have on addressing coinfection with TB 
and AIDS because of the enormous risk that this poses. While an 
effective approach, technical approach to TB control treatment, 
directly observed therapy short [DOTS] course, now exists--
there continue in fact to be major hurdles to be overcome 
before this can be widely applied in the developing world, and 
I would be happy to address those in followup questions.
    Without good program management, supply, and supervision, 
WHO has noted that no TB program is better than a poorly 
functioning TB program. It encourages the development of 
multidrug resistance, and that is what turns a treatable 
disease into an untreatable deadly disease.
    Is USAID doing enough to address infectious diseases in the 
world? Of course we are not. The needs are many times greater 
than the resources we have available to them. And yet AID today 
devotes a greater proportion of our development assistance 
funds than ever before to health, and we do not think it would 
be wise to further cut back on our corollary efforts in 
agriculture, combating poverty and hunger, basic education, 
environmental protection--all issues that I mentioned earlier 
as key factors in helping to prevent the spread of infectious 
diseases.

                           prepared statement

    Over the past decade, as you are well aware, Senator Leahy, 
our development assistance budget has been cut in approximately 
50 percent, a 21-percent decline in the past 2 years alone. If 
we are going to continue making progress combating infectious 
diseases and providing a first line of prevention and defense 
for the American people, it is critical in our opinion that the 
Congress approve the administration's full budget request for 
sustainable development for this coming fiscal year.
    Thank you.
    [The statement follows:]
           Prepared Statement of Nils Daulaire, M.D., M.P.H.
    Thank you Mr. Chairman for giving me an opportunity to present to 
this Committee information on global needs for the control of 
infectious diseases and on what the U.S. Agency for International 
Development is doing to address this challenge in the developing world.
                    key health issues in development
    Just two principal health issues in the developing world account 
for most of the gap between the health of their citizens and ours. Both 
are of direct importance to the development of their countries and to 
the continued security of ours. These two issues are the prevention and 
control of infectious diseases, and the promotion of reproductive 
health through family planning, safe pregnancy and delivery services, 
and prevention and control of sexually transmitted infections. Today I 
will address infectious diseases. But I would remind you of the 
continued importance of reproductive health, with its direct effect on 
decreasing the toll of injury and death to women and children, on 
allowing the poor--especially poor women--the opportunity to break free 
from the cycle of poverty, and on helping societies to escape from the 
trap of unsustainable population growth.
    The threat posed by infectious diseases to the security and well-
being of the global community is very real. Today we understand that 
national borders are irrelevant to microbes, and that in an 
interconnected world no disease is more than a day away from our own 
shores. We have learned that infectious diseases, and the conditions 
that engender them, must be dealt with at their source.
    While public attention has focused on acute outbreaks of exotic 
viral diseases such as Ebola, age-old bacterial diseases such as 
plague, and even new categories of ``prion'' diseases such as Mad Cow 
Disease (BSE), the larger infectious threats to human health are more 
commonplace and therefore less publicized. Deaths from outbreaks of the 
high-visibility diseases that I have mentioned number in the hundreds. 
Meanwhile, each year 17 million people die around the world as a 
consequence of more routine infectious diseases, principally vaccine 
preventable and bacterial diseases. This is where the true threat lies.
    USAID has contributed directly to control efforts for the rare and 
high-visibility outbreaks, but it is the large-scale threats to public 
health which are at the core of our health programs around the world. 
Let me stress that this is already a considerable part of USAID's 
budget--in fiscal year 1996, we estimate that USAID devoted 
approximately $320 million dollars to the direct prevention, control 
and treatment of infectious diseases, making us by a considerable 
margin the largest bilateral donor for this area.
    However, we do not consider a dollar comparison with other donors 
as the most appropriate yardstick of U.S efforts, and share the belief 
that the world's only superpower has good reason to do more.
                usaid's approach to infectious diseases
    Let me share with this Committee USAID's view of how infectious 
diseases should be addressed, where we have made our principal 
investments, and where we have been unable to do as much as we would 
like.
    The simple view of infectious diseases is that you wait for an 
outbreak, then go in with massive resources to stop it. Yet this is 
neither good resource management nor good public health--this must be 
our last resort, rather than our first line of defense. Prevention of 
disease is far more cost-effective than treatment and emergency 
response.
    In contrast, USAID's approach consists of four elements:
  --1. Basic prevention through changing the conditions that allow 
        infectious diseases to flourish and spread.
  --2. Secondary prevention through improving health systems so they 
        are themselves able to prevent and control infectious diseases.
  --3. Targeted prevention and control through specific focused 
        programs tailored to individual high priority diseases.
  --4. Response to emergency situations.
    Let me address each in turn.
Basic prevention through changing the conditions that allow infectious 
        diseases to flourish and spread
    The Institute of Medicine's groundbreaking 1992 report on emerging 
infectious diseases highlighted six underlying factors responsible for 
the spread of infectious diseases. They were:
    Human demographics and behavior; Technology and industry; Economic 
development and land use; International travel and commerce; Microbial 
adaptation and change; and Breakdown of public health measures.
    Ever-increasing international travel and commerce are the defining 
reality of today's global economy. They are responsible for much of the 
economic growth and vitality of virtually all of the world's countries. 
Yet they are also the principal conduits for the rapid spread of 
infectious diseases. Similarly, developments in technology and industry 
can also serve as spurs to the spread of disease. Other agencies are 
addressing these areas.
    USAID's work makes a vital difference in efforts directed at all of 
the other factors.
    We work to stem rapid population growth leading to overcrowded 
mega-slums, the true breeding grounds that allow diseases to reach a 
critical mass, through our efforts at family planning.
    We work to improve nutrition, and thereby strengthen resistance to 
the spread of diseases, through our efforts in economic development, 
agriculture and food security.
    We work to provide clean drinking water, reducing the transmission 
of deadly pathogens, through our efforts in both urban and rural water 
and sanitation programs.
    We work to enhance sustainable agricultural practices and natural 
resource management, reducing the growth of vectors and disease 
organisms, through our environmental programs.
    And last but by no means least, we work to improve public health 
measures and decrease the chances of dangerous microbial changes 
through our support of health systems.
    These efforts are the essential aspects of a true long-term 
prevention strategy. The fact that they have other equally important 
benefits outside the area of infectious diseases makes them even more 
valuable as essential elements of our integrated approach to 
sustainable development.
Secondary prevention through improving health systems so they are 
        themselves able to prevent and control infectious diseases
    While it is appealing to think of American doctors coming to the 
aid of countries around the world, the growing reality of the world is 
that countries must provide their own first line of defense. They must 
be able to manage, run and support their own health systems if they are 
to control infectious diseases. A great deal of USAID's assistance in 
health over the past several decades has been directed at key elements 
of sustainable health systems. This is not only more cost-effective, 
but is an investment which bears long-lasting results.
    We work to develop the capacity of host-country nationals to carry 
out their own training, supervision, logistics, information systems, 
communications, and budgetary management.
    We assist in reforming health system policies and financing 
mechanisms to encourage collaboration between public and private sector 
health providers.
    We work to reform national pharmaceutical policies, regulations, 
training, and provider and client practices to ensure appropriate (and 
minimize inappropriate) use of antimicrobials and other drugs and to 
improve the quality of pharmaceuticals that people use.
    We assist health systems in applying more effective epidemiologic 
surveillance systems for detecting and responding to outbreaks, and 
health information systems for monitoring trends of disease over time 
and for tracking progress in targeted disease control programs.
    We assist in the development of new low-cost preventive, 
diagnostic, and treatment technologies, and in the use of information 
and communications technologies to enhance health programs and health 
education efforts.
    Ultimately, we look to leaving successful and workable health 
systems in place when USAID assistance has come to an end, as we have 
done in countries as diverse as Thailand and Costa Rica. These systems 
serve as the true first line of defense against infectious diseases.
Targeted prevention and control through specific focused programs 
        tailored to individual high priority diseases
    USAID's health programs also target specific infectious diseases 
which are the principal contributors to death and illness around the 
world. Of the 17 million annual infectious disease deaths, the majority 
are among children, and the large majority of child deaths are caused 
by infections. Therefore, most of our child survival efforts are 
specifically targeted against major infectious disease threats. These 
efforts have already resulted in 3 million fewer deaths per year 
according to UNICEF. They include:
  --Diarrheal disease control, including cholera and dysenteries, all 
        caused by infectious microbes and causing more than 3 million 
        annual deaths and hundreds of millions of infections.
  --Prevention and control of pneumonia, the cause of more than 4 
        million deaths each year.
  --Immunizations against the major vaccine preventable diseases of 
        childhood, especially measles, tetanus, diphtheria, and polio--
        diseases which cause nearly 2 million deaths.
  --Prevention, control and treatment of malaria, responsible for over 
        2 million deaths, more than 90 percent of which are among 
        children primarily in sub-Saharan Africa.
  --Efforts within treatment programs, such as against pneumonia, to 
        assure appropriate and full courses of antimicrobial treatment 
        to minimize the likelihood of antibiotic resistance.
  --Targeted research in testing new vaccines, technologies and 
        treatments against the major childhood killers.
    In addition to our child survival efforts, the other major targeted 
component of our current infectious disease efforts is directed at the 
prevention and control of today's most threatening and costly newly 
emerged infectious disease: HIV/AIDS. For the past decade, USAID has 
played a leading role in developing the tools needed to combat this 
epidemic, and in helping countries to apply these tools.
    USAID also actively supports applied research on a range of 
infectious disease issues. These include:
  --Development of more effective, safe, and less expensive vaccines, 
        and strengthened systems for their delivery.
  --Strengthening systems for early case detection; diagnostics and 
        treatment protocols that are more effective, easy-to-use, and 
        less expensive; behavioral research and change in key aspects 
        of disease risk and in how families seek and access appropriate 
        care.
Response to emergency situations
    As I noted earlier, USAID was a major contributor to the emergency 
response to the Ebola outbreak in Zaire and played a smaller role in 
responding to the plague panic in India; we have played a similar role 
over the years in numerous emergencies around the world. However, we 
strongly believe that responding to emergencies should be our last 
recourse, not our first, and we worry that essential prevention and 
control efforts may inadvertently be undermined by a diversion of 
resources to whatever has most recently appeared on CNN.
              issues relating to malaria and tuberculosis
    As I have described, USAID's efforts in addressing infectious 
diseases over the span of several decades have been and continue to be 
considerable. This is not to argue that they have always been 
sufficient. As resources for development assistance have declined, so 
has our ability to mount major efforts targeted at specific infectious 
diseases.
    I would like to highlight two important infectious disease threats 
which pose particular challenges to the world community: malaria and 
tuberculosis. Malaria kills more than 2 million people each year, 
principally children. Tuberculosis is responsible for more than 3 
million deaths, the majority of whom are adults in their working years.
Malaria
    Over the decades, USAID has devoted substantial resources to 
malaria control--more than $1 billion since the 1950's. In recent 
years, with the considerable success of these efforts in countries of 
Latin America and Asia which were the principal focus of our efforts, 
we have moved to a more targeted approach.
    Currently, we focus our malaria efforts around our child survival 
activities. We recognize that malaria, particularly in Africa, is a 
major killer of children. Indeed, approximately a third of all deaths 
of children under age five in Africa are related to malaria. To 
maximize our investment, we have focused on a few key areas.
  --USAID's Malaria Vaccine Development Program (MVDP) is now focused 
        on finding a vaccine that is effective for children in high 
        endemic areas. We have partnered closely with the National 
        Institutes of Health (NIH) and the Walter Reed Institute of 
        Research (WRAIR) to maintain a substantial U.S. effort in all 
        of the necessary stages of malaria vaccine development, and 
        coordinate well with WHO, EU and other donors. This enables us 
        to translate current knowledge into experimental vaccines which 
        can be tested in humans. In fiscal year 1996, initial safety 
        studies of a new USAID initiated experimental malaria vaccine 
        were conducted in cooperation with other USG Agencies, and a 
        second experimental vaccine is scheduled for testing this year.
  --Last year, USAID established the Africa Integrated Malaria 
        Initiative (AIMI) to apply the technologies now known for 
        combating malaria. AIMI promotes a comprehensive ``package'' of 
        approaches, including the first large scale, sustainable 
        impregnated mosquito net program in Africa.
  --Extensive malaria control activities take place under other USAID 
        programs. We are the lead bilateral donor and have played an 
        important technical leadership role in WHO's initiative for the 
        Integrated Management of Childhood Illness (IMCI), which sets 
        clear clinical standards for treating malaria and its 
        complications. Our support for the development of new 
        technologies has produced two promising diagnostic tests that 
        health workers in the field can use to rapidly confirm malaria 
        parasite infection in a cost-effective manner. USAID continues 
        to train national malaria program managers, in Africa 
        especially, in information systems and operations research.
    More needs to be done, however, in terms of investments in vaccine 
development and testing, in efforts directed at controlling the 
mosquito vectors of malaria, in developing innovative new approaches in 
malaria prevention and in assuring that these approaches are both 
practical and sustainable.
Tuberculosis
    TB is today reemerging as a leading infectious scourge of mankind 
after years of decline. USAID's principal efforts, outside childhood 
BCG immunization (which provides modest protection against new TB 
infection), have been in support of programs aimed at developing a 
rational approach to managing TB among people with HIV infection. Since 
the chance of rekindling an active case of TB rises by a factor of ten 
as a result of the immunosuppression that comes with HIV, we believe 
this is a critical area for action.
    While the global need for stronger efforts directed at TB is 
obvious, practical solutions in the reality of most developing 
countries are less apparent. WHO has recommended that widescale TB 
control efforts not be initiated in the absence of confirmable and 
strong program management and oversight. The principal risk of a 
widespread poorly run program is the high likelihood that multi-drug 
resistance will develop, transforming TB into an untreatable deadly 
disease.
    It has been our experience that health service delivery systems in 
developing countries are generally not well prepared to attack TB 
systematically and on the scale which is required. TB experts have 
recognized that treatment and control of TB is among the most labor-
intensive of health interventions; current protocol calls for direct 
health provider contact with each TB patient several times a week 
during the entire eight months of short course therapy.
    We have found that in most of the developing world where TB is most 
prevalent we have had to start more or less at the foundation of 
building a health care delivery system before it would be appropriate 
or effective to launch an effective program for a nation-wide treatment 
of this health problem. In fact, a considerable portion of USAID's 
health budget, over $27 million each year, is aimed directly at health 
systems development and strengthening. Without this, efforts at TB 
control would be futile.
    While we do not ``count'' this health systems funding as TB-related 
because it has effects on the control of virtually all major public 
health problems, our successes in establishing improved public health 
systems mean that the more closely targeted TB efforts of others have a 
far better chance of succeeding. USAID's involvement has made an 
important difference.
    It is clear that the resource needs of a truly global effort to 
address TB are enormous, in all likelihood dwarfing today's AIDS 
control efforts. This is unquestionably the biggest unmet need among 
infectious diseases today. Nonetheless, I would argue that in terms of 
resource prioritization, our continued emphasis on health systems 
development and other important and more easily addressed infectious 
diseases is appropriate. The former because TB control efforts will 
only work once operational health service delivery systems, well-
managed and well-supplied, are in place. And the latter because we have 
proven, cost-effective technologies ready for delivery to save lives.
                               conclusion
    Is USAID doing enough to address infectious diseases around the 
world? Of course not--the needs are many times greater than the 
resources we have available to apply to them. Yet USAID devotes a 
greater proportion of our Development Assistance funds than ever before 
to health, and we do not think it would be wise to further cut back our 
efforts in agriculture, combating poverty and hunger, basic education, 
environmental protection--all, as I have mentioned, key factors in 
helping to prevent the spread of infectious diseases. We would urge 
this Committee not to cut these critical budgets below the President's 
request level.
    We continue our efforts to meet this challenge, recognizing the 
greater need before us, and working to make the most efficient use of 
the resources the Congress has made available to us to improve both 
human health and the human condition in the countries of the developing 
world. These efforts are broader than USAID or any single agency. In 
June 1996, President Clinton released a policy directive that 
recognizes emerging infectious diseases as both a domestic and an 
international threat. The policy directive calls for improved 
international cooperation, training, surveillance, research and public 
awareness of these diseases. The President's directive grew out of an 
initiative of the National Science and Technology Committee on 
International Science, Engineering, and Technology, which created the 
report, Infectious Disease--A Global Health Threat. USAID has been a 
key participant in the CISET initiative, and USAID's programs of 
prevention and cooperation are an integral part of the President's 
strategy to protect the health of U.S. citizens and the global 
community.
    In giving top priority to prevention, and in helping countries to 
develop their own capacities to prevent and control infectious 
diseases, USAID continues to play an essential role in this effort, 
consistent with the requirements of sustainable development and the 
long-term interests of the American people.
STATEMENT OF GORDON DOUGLAS, M.D., PRESIDENT, MERCK 
            VACCINES, MERCK & CO.
    Senator Leahy [presiding]. Dr. Douglas.
    Dr. Douglas. Senator, it is a pleasure for me to be here 
and have an opportunity to address this question, which is very 
important to me personally as well as to the company I 
represent, which is Merck. I am the president of the Vaccine 
Division at Merck & Co., Inc., and I am by background a medical 
doctor and a specialist in infectious diseases.
    We believe that an increased effort--and I emphasize, 
increased--on the part of the United States to understand and 
control infectious diseases in developing countries is both 
vital to our national interest and it constitutes good public 
health policy as well. I think you should recognize it as not 
only support through the various agencies that you support, but 
with good policies you can enlist the help of the medical 
schools and universities in the United States, private 
industry, certain scientific and philanthropic foundations as 
well.
    What I would like to address in my comments is what you can 
do to help us, and there are really two things you can do. 
First, you can support adequate medical infrastructure in the 
poorest countries in the world so that drugs and vaccines can 
be used--and I will come back to that in a little bit more 
detail--and second, create a business climate so that U.S. 
vaccine and drug companies can operate effectively.
    I want to do this with a story from our experience with 
Mectizan, which has been a very successful program in public 
health, because we can learn something about what is possible 
and what are the limitations and barriers to being successful. 
In the 1970's we developed a drug which we refer to as 
Mectizan, and we developed it in a program where we were 
looking for remedies for parasitic diseases in large farm 
animals, such as horses.
    It turned out that this drug was unique and was the most 
effective antiparasitic drug that had ever been developed to 
that time. And it was noticed that it was effective against a 
parasite in horses which closely resembled a parasite which 
infected humans and caused a disease which is known as river 
blindness, or onchocerciasis. People inside the company and 
outside the company persuaded the company to develop it for 
that use, that is for river blindness, and we began our first 
human trials in Senegal and realized that this disease 
afflicted about 20 million people in the poorest countries in 
the world, in the remotest regions of the world, and with 
either very primitive or absent health care systems.
    It became obvious there was no international market for 
this drug and that the proper solution was to donate it for use 
in river blindness, and so that Merck did this. Our biggest 
concern immediately when we got into the issue was the lack of 
medical infrastructure in the countries where persons were 
affected with river blindness.
    Now, you have to remember that this is a very, very simple 
regimen. One pill taken once a year is sufficient to cure this 
disease. It is a remarkable drug. However, in the countries 
which we were dealing with there was no mechanism of assuring 
that that could be done. One has to make a diagnosis in a 
patient, make sure that that is the right patient to treat. You 
have to persuade the patient that the drug is safe. They are 
not used to modern medicines. You have to get the drug to the 
patient. You have to make sure when patients line up that you 
are not treating the same person over and over again because 
they do not know the difference. You have to maintain records 
therefore. You have to assure treatment of all the patients 
with the disease.
    These are major issues that have to be solved, and you need 
at least a basic medical infrastructure in place for that to 
happen. And finally, you have to secure funding for the 
distribution of the drug.
    We first had to convince people at the tropical research 
program at the WHO that this was important. Previously they had 
emphasized a program of spraying for black flies. The black 
flies transmit this parasite from person to person. And that 
program faced all the problems with spraying for mosquitoes for 
malaria, for example, and it was doomed to failure. Our drug 
worked against the microfilaria, which was the organism which 
actually caused the disease.
    The solution we came up with was to set up a Mectizan 
expert committee, which established criteria and reviewed 
applications from countries and regions from people who wanted 
to use the drug. And we put in charge of this Bill Fagey, the 
former head of the CDC, who is now the executive director of 
the Carter Center. With the cooperation of the Carter Center, 
the Mectizan expert committee, plus the donation of the drug, 
we have had a very, very successful program, and I am pleased 
to report that about 20 million people are currently under 
treatment and have been getting treatment repeatedly on an 
annual basis with this drug.
    The point is that having the drug is not enough. Access to 
health care or at least an adequate health care infrastructure 
is essential for administration of either a vaccine, because 
remember this is a vaccine-like drug in that it requires a 
single medical intervention once a year in a person, those 
appropriate services have to be available. You have to have 
full cooperation with the government at all levels in the donor 
country.
    Senator Leahy. That is once a year as long as the person is 
in the area where they are at risk?
    Dr. Douglas. Presumably, yes.
    And it is essential that this cooperative atmosphere was in 
place and the infrastructure was in place and the assurance the 
drug could be given.
    Now, if you magnify this problem just a little bit and 
think about the example about tuberculosis that has just been 
described here and will be described some more, remember that 
in tuberculosis it is several drugs given several times a week 
over an extended period of time. It is a much more difficult 
problem.
    And if you take it one step further, in the United States 
today with the advent of the protease inhibitors--and Merck 
developed one of them, Crixivan--we have changed AIDS into a 
disease that was life-threatening in all individuals to one 
that looks today as if it can be chronically medically managed, 
which is an enormous change. It is a very complex regimen. It 
is multiple pills, multiple times a day, up to eight pills per 
day, many given at points of dietary restriction, and making 
the diagnosis, monitoring therapy, monitoring for side effects, 
is critical to making this drug successful.
    In addition, if it is not done in both tuberculosis and in 
AIDS, if inadequate therapy is given, it leads to the emergence 
of resistant strains. And it is going to happen in AIDS just as 
it has happened in tuberculosis, and that is a threat to people 
in the developed world, including the United States.
    The goal in HIV therapy is to drive down the virus load 
with the persistent giving of multiple drugs, and if you cannot 
assure that then drug therapy cannot be given.
    Finally, I would like to turn to my last comment, which has 
to do with the barriers to American vaccine and pharmaceutical 
companies to participating in the lower economic markets in the 
world. These are listed in my written--I have listed eight such 
barriers, such as inadequate protection of intellectual 
property and parallel trade in patent product medicines, 
government price controls, et cetera. Those are listed there. I 
would be happy to discuss those in more detail during the 
question and answer period.

                           prepared statement

    I would just finally like to conclude by saying that if you 
can help us in these two areas, that is building up the medical 
infrastructure in the poorest countries in the world so that 
our drugs and the vaccines which we invent--what a company like 
Merck can do best is to discover, develop, produce, and 
distribute new and innovative medicines that can help solve 
some of these worldwide infectious diseases problems.
    Thank you.
    [The statement follows:]
                Prepared Statement of R. Gordon Douglas
    Good morning Mr. Chairman and members of the Committee. My name is 
Dr. Gordon Douglas.
    I am a medical doctor and a specialist in infectious diseases and 
President of Merck Vaccines.
    Merck believes that an increased effort on the part of the United 
States to understand and control infectious diseases in developing 
countries is both vital to our national interest and constitutes good 
public health policy.
    The discovery of penicillin more than 60 years ago instilled 
Americans with a level of confidence in our battle against infectious 
diseases that no longer applies. It is all too apparent today that 
resistant bacteria, antiviral-resistant viruses, and ``new'' infections 
resulting from ecological changes threaten our society. Indeed, 
infectious diseases are an increasing cause of death in the United 
States.
    This nation's renewed war against infectious diseases should not 
fall on the shoulders of our government alone. Private industry, 
medical schools and other academic institutions, and scientific and 
philanthropic foundations can and do have a role to play. Nor should we 
view this as a problem exclusive to the U.S. On an international level, 
we should build on the solid base of experience provided through the 
ongoing work of the World Health Organization (WHO), the World Bank and 
United Nations' Children Fund (UNICEF).
  barriers to controlling infectious diseases in developing countries
    Solutions to controlling infectious diseases include more than just 
direct spending by various government agencies. Providing access to 
comprehensive health services in developing nations presents a unique 
set of challenges including, poor nutrition and sanitation, lack of 
trained medical staff, minimal medical facilities (particularly in 
rural areas), lack of disease awareness, poor or non-existent medical 
recordkeeping capability or capacity. We need a comprehensive public 
policy that addresses issues ranging from research initiatives to 
health-care delivery infrastructure, and whose implementation depends 
on strategic partnership efforts between government and other segments 
in society. A recent loan condition adopted by the World Bank is a good 
example of such policy. For a nation to secure World Bank resources, it 
must demonstrate compliance with the WHO's Expanded Program of 
Immunization.
    Mr. Chairman, Merck's own involvement with infectious diseases over 
the last century illustrates the range of contributions that you should 
anticipate from the private sector as a result of our long-range 
commitment to better health worldwide.
    First is our commitment to--and success in--the discovery and 
distribution of vaccines as a preventive weapon against infectious 
diseases. Measles, mumps, rubella, hepatitis, Haemophilus influenza 
type B, varicella (or chickenpox)--all can be prevented through 
immunization with Merck vaccines.
    In our pipeline we are developing preventions against rotavirus, a 
potentially deadly disease for children in developing nations, and 
against otitis media.
    Second, with our research in antibiotics, we've made major 
contributions in the treatment of infectious diseases. Streptomycin--
which Merck discovered and developed in collaboration with scientists 
at Rutgers University in the 1940's--was one of the first important 
drugs for the treatment of tuberculosis and is still used in many parts 
of the world today.
                    lessons from the mectizan story
    Our experience with the donation of our drug, mectizan, to prevent 
onchocerciasis, or river blindness, offers several key lessons for 
policies and programs designed to deal with infectious diseases in 
developing countries. River blindness is a disease that affects 
approximately 20 million people, mostly in sub-Saharan Africa.
    During the 1970's, Merck researchers pursued the development of a 
new, powerful anti-parasitic compound that proved effective in the 
prevention of parasites in horses. While testing the drug on animals, 
our researchers noticed that it was effective against a parasite that 
resembled the one that causes river blindness.
    An infectious disease doctor working in Africa who had seen, first-
hand, the ravages of river blindness, championed further investigation 
of the potential human applications for Merck's animal drug.
    Human clinical trials were begun in Senegal. But even as we 
proceeded with our research , it became very clear that the need for 
mectizan was limited to a narrow band of countries and that the 
communities in need of the drug are among the very poorest in the 
world, in the most remote areas, with only the most primitive of 
healthcare services available. Far from anticipating an international 
market, Merck recognized that the target population probably could not 
afford to pay for the drug at any price and decided to donate the drug.
    Our biggest concern with donating mectizan was the lack of a 
medical infrastructure and a commitment at every level of government to 
get the drug to the people. Absent these, a donation was valueless. 
Even though mectizan involves only minimal medical care--just one pill, 
once a year--there was no possibility that Merck alone could establish 
a delivery and monitoring system that would assure the drug was used 
successfully. The product is relatively easy to handle, store and 
transport. Yet the significant challenges to delivering it and getting 
it administered--establishing a system of identifying potential 
patients, persuading them the drug was safe to take, getting the 
patients to the drug or the drug to the patients, maintaining records 
of the drug's administration and securing a source of funding to cover 
distribution--cannot be overstated.
    Ironically, one of the major challenges involved convincing experts 
at the WHO's Tropical Disease Research program to make distribution of 
mectizan a priority. Their focus had been on eradicating the blackflies 
that carry the disease and killing the adult worms that cause it, 
whereas mectizan was particularly effective against the microfilariae, 
or larvae.
    The solution was to create an independent committee of experts in 
tropical medicine--The Mectizan Expert Committee (MEC)--to establish 
criteria for mectizan treatment programs, and to review applications 
for free supplies of the medicine. This procedure allowed the orderly 
development of guidelines for distribution, the monitoring of any 
adverse reactions, and record keeping. The MEC was headed by Dr. 
William Foege, executive director of the Carter Center--the institution 
created by President Jimmy Carter to promote third-world development.
    Having drugs for infectious disease is not enough, as the mectizan 
experience demonstrates. Access to adequate health care infrastructure 
and appropriate medical services, having the full cooperation, 
participation and commitment of all levels of government, including the 
activities of international agencies in the areas where river blindness 
occurs, has been critical to the successful use of mectizan--a drug 
that is relatively easy to distribute and monitor. These challenges 
pale in comparison to those we face in successfully tackling TB and 
HIV/AIDS.
    Despite availability of several effective anti-TB drugs, millions 
of people suffer from TB worldwide. Failure to use these therapies 
appropriately has led to the widespread emergence of TB strains that 
are resistant to existing antibiotics. Furthermore, the HIV/AIDS 
pandemic has provided a fertile breeding ground for the spread of 
multi-drug resistant TB.
    You are probably aware of the remarkable progress that is being 
made toward turning HIV infection into a chronic, manageable disease 
with the advent of combination drug anti-HIV therapy and the growing 
use of a new class of compounds, the HIV protease inhibitors. But these 
new drugs are extremely complicated to take.
    Merck developed one of these new HIV protease inhibitors, Crixvan, 
after a ten-year intensive research effort. Thousands of people with 
HIV now are coming forward for treatment, challenging the capacity of 
the HIV drug budgets in the public and private sectors in the U.S. and 
Europe. The bigger challenge is how such therapies can be used in 
developing nations, which bear the burden of over 90 percent of all HIV 
infections worldwide.
    Clearly, the challenges of HIV/AIDS treatment in these nations are 
magnified many times over by the requirements of a complex drug 
regimen--multiple doses of multiple drugs that must be taken every day, 
most with dietary restrictions. For example, many patients are taking 
eight or more different drugs every day. In addition, these patients 
must undergo stringent monitoring that requires regular laboratory 
tests. This, in turn, requires the clinical laboratory capacity to 
perform and evaluate these tests.
    A major goal in the use of these new HIV therapies is to drive down 
and keep the virus at undetectable levels, but this must be done in a 
manner to prevent the emergence of an AIDS virus that is resistant to 
treatment with the new therapies. Patients must adhere to a strict 
schedule, for instance Crixvan must be taken every eight hours on an 
empty stomach or with a low-fat meal. They must have continued, 
uninterrupted access to therapy and must have overall comprehensive 
AIDS care, that is, access to drugs to treat the opportunistic 
infections (such as TB), and access to sophisticated laboratory tests 
to monitor the response to therapy. Unfortunately, relatively few 
places outside of the OECD countries can offer a critical mass of HIV 
care to benefit the patient and protect the public health from the 
development of drug-resistant HIV.
                barriers to international participation
    Merck annually dedicates thousands of research hours and millions 
of dollars toward the discovery, development and production of new 
vaccines and medicines targeting the prevention and treatment of 
infectious diseases. And we welcome the opportunity to work with this 
Committee, and others, to formulate public policies that will provide 
true benefits.
    But we face some significant barriers, Mr. Chairman, barriers which 
are shared by other U.S. pharmaceutical and vaccine companies that want 
to supply developing countries. These barriers include, but are not 
limited to:
  --Inadequate protection of intellectual property--specifically, that 
        countries are failing to meet the Trade Related Intellectual 
        Property Sections (TRIPS) of the GATT agreement designed to 
        protect our patent's confidential data and trade secrets, and 
        even to accept that TRIPS should remain in force.
  --Parallel trade in patent-protected medicine also serves to 
        undermine our property rights--property rights that fuel 
        research and development for tomorrow's medicines. Parallel 
        importing arises when different prices are set by governments 
        among price-controlled markets. A wholesaler purchases drugs in 
        a market with a low price and then resells the product in 
        markets with a higher price, pocketing the profits.
  --Government price and profit controls that limit research incentives 
        and the revenues needed to invest in high-risk development 
        programs.
  --Black market sales that often divert products from those who need 
        them most.
  --The lack of quality assurance and the willingness to compromise on 
        quality to achieve cost savings.
  --Inadequate resources for countries to acquire effective therapies 
        and newer vaccines which necessarily cost more than older 
        vaccines.
  --Epidemiology gaps, by which I mean inadequate data to assess the 
        occurrence or incidence of an infectious disease in a given 
        country.
  --And finally, as explained more fully above, the lack of health 
        system infrastructures that can support rigorous treatment 
        regimens.
    An environment enabling U.S. drug and vaccine companies to operate 
effectively is needed to ensure delivery of the best quality, most 
effective products. For the poorest countries, however, even this is 
not enough. These countries need more resources to carry out even 
minimal care programs and thus the involvement of agencies such as the 
WHO, the World Bank and UNICEF. Clearly vaccines, which may require 
only one interaction with a patient, offer much greater hope for these 
parts of the world than do complex treatment regimens.
    Mr. Chairman, without question the issues surrounding global 
infectious disease warrant this Committee's attention. They are serious 
issues--they are growing issues--and they represent a clear threat to 
the United States. By promoting an environment in which U.S. industry 
can operate most effectively overseas, and ensuring adequate funding 
for key international agencies, Congress maximizes America's ability to 
contain this threat.
    I thank you for the opportunity to share these thoughts with you 
today and I look forward to your questions.

                      strengthening infrastructure

    Senator Leahy. Believe me, Dr. Douglas, you have a lot of 
people in this room on both sides of this dais who would like 
to see how best to strengthen that infrastructure. A lot of it 
comes down just to one thing, money. That is also why I made 
the comment I did earlier, that the nations of the world can 
spend hundreds of billions, even trillions, of dollars a year 
on defense. A lot of it may well be justified. But we have got 
to realize that this is part of our national security and the 
amounts of money that we are talking about are so infinitesimal 
compared to what we spend on armaments and standing armies, 
navies, and air forces.
    You have millions, tens of millions, hundreds of millions 
of people traveling every day around the world, crossing 
borders. That is the guided missiles coming in, the viruses 
that travel with them.
    And there is the humanitarian aspect. You mentioned river 
blindness. I was born blind in one eye and I know how 
frustrating that has been to me throughout my life. But I do 
not have to work at a job where I need both eyes.
    When I hear about river blindness I instinctively shudder. 
I think of somebody who has lost both eyes in a place where 
they are not a U.S. Senator with a staff and everything 
available to them, but somebody who has got to go out and grow 
their crops, make their living off their land, sometimes the 
most difficult things. And to think that it can be easily 
prevented.
    And river blindness is not, I would assume, going to affect 
us here in the United States. But if we live in the wealthiest 
nation history has ever known, 5 percent of the world's 
population using 25 percent of the world's resources, then 
something ought to tell us we have a moral responsibility, a 
very great moral responsibility to help those people.
STATEMENT OF JOHN SBARBARO, M.D., PROFESSOR OF MEDICINE 
            AND PREVENTIVE MEDICINE, SCHOOL OF 
            MEDICINE, UNIVERSITY OF COLORADO HEALTH 
            SCIENCES CENTER
    Senator Leahy. Dr. Sbarbaro.
    Dr. Sbarbaro. Senator, you just kind of summarized 
everything I was going to say and I will make this very 
comfortable for you.
    Senator Leahy. Go ahead and say it anyway.
    Dr. Sbarbaro. It was really insightful.
    I was asked to come up with a disease that kind of 
exemplified what all my colleagues, the points that they have 
made. The obvious answer is tuberculosis. I was thinking how 
best to do this, so to make it personal for everybody in this 
room I would kind of like you to assume that I have pulmonary 
active tuberculosis. And it is a bacteria, and unfortunately it 
is one of those bacteria that can stay alive outside the human 
body and it is spread basically through the air.
    If you all take a deep breath. The group behind me has just 
breathed in one bacteria, OK. That is going to grow in their 
body over the next 6 to 8 weeks, spread throughout their body, 
and then 1 out of 20 sitting in the room right now will 
progress on to active pulmonary tuberculosis and share their 
disease with somebody else.
    Now, the other ones, the 19 out of 20, are going to put 
that bacteria into a dormant state, but it is going to stay 
alive in their body. And another one, 1 out of 10, is going to 
develop the disease in the rest of their life and then they are 
going to share that with somebody else.
    So if you will all just take a deep breath now. OK, got it?
    Senator Leahy. They have been holding their breath ever 
since you coughed. I am waiting for them to start passing out 
back there.
    Dr. Sbarbaro. This is why your wife is noticing the panic 
in hospitals, because this is a disease that you cannot protect 
yourself from. It is spread through the air. And I just do not 
see everybody back here wearing masks. And unfortunately, the 
ones that get the disease the most are those age 18 to 40, and 
that is the economic base of a country, and when they die, 
because when you get the disease prior to chemotherapy, prior 
to us developing any drugs, what do you think your chance of 
survival, guys, is? Two out of three people died within 5 
years.
    I mean, you want to talk about an epidemic that scared the 
hell out of people. Two out of three people dying within 5 
years. And that is why we put them in TB sans. You did not 
notice them dying and they were not around.
    When chemotherapy came along, drugs, the problem was all 
over, and we said: Good deal, that is great. Unfortunately, if 
you look at the rest of the world, as Barry Bloom said, you 
have 7 to 8 million new cases a year. You have 2 to 3 million 
deaths a year. You are going to have 30 in the next decade, 30 
million in the next decade.
    But what really bothers me is that one out of three people 
in the world are walking time bombs like the people just behind 
me, harboring live TB bugs. And we have kind of got a huge 
stake in this thing because, if you think about all these 
folks, where do you spread TB the most? In confined areas. How 
do we travel? In airplanes. We have international trade. We 
have international students. We have multinational companies. 
We have immigrants.
    And if you will notice, in our own country a great deal of 
our disease comes from folks coming on in, because we have 
managed to control this disease, we got rid of it, and so most 
of our people--the good news is that most of our people under 
the age of 40 have never had contact with TB and are, 
therefore, not infected.
    The bad news is that most of our people under the age of 40 
have never had contact with TB, are not infected, and when 
somebody comes in with a drug-resistant organism because we 
have treated people poorly in other countries, we are now 
susceptible. One of our kid gets the disease, we then spread it 
to the rest of our kids, and what you have is a new epidemic in 
our country and we are back to the era of sanitariums.
    So comes the question, is there a solution that can work? 
And yes, there is. WHO has actually come up with a program that 
works. As mentioned by the AID groups, it is called DOTS, 
directly administered therapy. And what it requires, all it 
requires, is that somebody watch the patient take the drugs. 
That means the patient has to take all the drugs and cannot 
take only one or the other, and if they are not there they do 
not take it and, therefore, you do not get drug resistance.
    Now, as Dr. Douglas pointed out, what you need is a health 
structure. What has been unique is that they have introduced 
DOTS into 70 countries already and it does not require changing 
the health structure. What you have is primary health care 
workers in many of these countries, just village workers, and 
when they start giving medications out it actually increases 
their status.
    What is interesting is that when people start to get well, 
other folks come on over to them, and suddenly you have created 
a health system. You have enhanced the health system of the 
country, not had to go and create a whole new program.
    So if you take a look at what has happened in the 70 
countries where they have introduced it, you have cure rates in 
China, India, Bangladesh, Nepal, and Peru where it has been 
implemented of 90 to 95 percent. That is compared to 40 percent 
anywhere else. In Russia where they have not done this, you 
have gone from 50,000 cases in 1991 to 85,000 new active cases 
in 1995. If you are wandering through Russia, do not breathe.
    Specifically what can be done? Well, I thought about this a 
great deal, and WHO has started to move TB toward the top of 
its priority. It has got good wisdom. No. 1, I would actually 
encourage, ask the Senate to encourage, WHO to move TB up a 
little higher and to use some of their assessed moneys toward 
that program.
    No. 2, encourage the World Bank to continue what it started 
to do, and that is lend money for the specific purpose of 
controlling TB. Why? Because it hits the economic base of the 
country, the folks age 18 to 40.
    No. 3, we really, really need the leadership and strength 
of the USAID. They made TB a focus as part of AIDS. I would 
love to see them make TB as a focus for TB.

                           prepared statement

    Finally, if we could put some of our own money into WHO's 
DOT program and not to go out there and treat everybody, but 
what has been very apparent is that WHO uses it as seed money. 
They go in, they start a program, it becomes very convincing to 
that government, and that country puts their own money into it. 
So I do not want to see us--I do not think we can take care of 
the entire world, but we can certainly use our money as seed 
money to make things happen.
    So we have the cure. We can stop the disease, and all we 
need is the will, the commitment. You know, it is the old 
story: Pay now or pay later.
    Thank you, sir.
    [The statement follows:]
           Prepared Statement of John Sbarbaro, M.D., M.P.H.
    My name is John Sbarbaro and I am M.D., M.P.H. affiliated with the 
University of Colorado Health Sciences Center and the medical adviser 
to the Global TB Education Fund. The witnesses who have come before me 
have told a compelling story of the threat infectious diseases pose for 
the United States and people around the world. Now I want to tell you 
the story of one infectious disease in particular--tuberculosis.
    The reality of controlling tuberculosis is that the answer is not 
waiting in a lab. We have had a cure for tuberculosis for over forty 
years. We're ready to go. Controlling this deadly epidemic rests in the 
hands of policymakers such as yourselves.
    TB is the leading infectious disease killer of adults worldwide: 
One out of every three people in the world today carry live TB bacteria 
in their body--walking time bombs--with 8 million new cases of 
contagious TB emerging every year. And that number is increasing.
    TB kills more people than AIDS and all the other infectious 
diseases combined: 3 million deaths per year--hitting especially hard 
those between the ages of 18 and 40, which most often means income-
earning parents, giving tuberculosis the morbid distinction of being 
the disease that creates more orphans and condemns more children to 
poverty than any other; and 30 million deaths will occur in the next 
decade from what is right now, in most cases, is still a treatable 
disease.
    And TB constitutes a clear, present, and continuing danger to U.S. 
citizens for the simple reason that it is: spread through the air; 
fatal if not properly treated and perhaps worst of all, mistreatment 
accelerates the emergence of virtually untreatable drug resistant; and 
strains that threaten us all and raises the specter of a return to era 
of sanitariums.
The U.S. has a huge stake in this epidemic and must take action
    The U.S. overcame its TB epidemic in the mid-fifties by combining 
the discovery of effective antibiotics with well directed government TB 
control programs. It then packed its bags and checked out of the TB 
control effort.
    While we were able to close our nationwide collection of 
sanitariums, TB-related medical school curricula, funding for TB 
research and government programs also disappeared.
    The good news is that most of our citizens under the age of 40 have 
had no contact with TB and therefore are not infected.
    The bad news is that most of our citizens under the age of 40 have 
had no contact with TB and therefore are at risk of new infection in 
this world of increasing international travel, immigration, trade, and 
the growth of multi-national companies. And if we continue to let TB 
treatment in the epidemic countries be done poorly, the new TB 
infections will be caused by untreatable, drug resistant organisms.
    Since we cannot prevent the disease from coming into our country, 
its clear that we have to control the epidemic at its source--the 
poorer countries of this world.
    Practically speaking, it is much more cost effective in the long 
run to contribute to controlling TB in another country than to treat 
just the citizens and visitors of our country when they fall sick as a 
result of a TB infection acquired elsewhere.
    Morally speaking--this is a disease that right now we can actually 
cure. Treatment is effective and of equal importance, treatment is the 
best prevention available today as it stops the spread of the disease. 
Treatment not only helps the sick individual but it protects families 
and the community.
    This is one fight that the U.S. should lead; but to date, as a 
nation, we've hardly even been involved.
Today's TB epidemic is not a failure of science, it is as failure of 
        public policy
    Today's TB epidemic is not the result of a failure of science; it 
results from a failure of public policy. The disease can be controlled 
and yet more people will die this year than in any other year in 
history.
    Years ago we found the cure for tuberculosis, but we have not 
focused on continuing to apply it. It is a lack of political will that 
has allowed TB to return and it will take the full force of political 
determination to bring this epidemic back into check.
    In a perverse and deadly irony, the more we allow tuberculosis to 
spread, the more deadly the disease becomes as a result of poor and 
partial treatment. It is estimated that there may be as many as 50 
million people infected with drug-resistant TB in the world today. 
Drug-resistant strains of TB are a man-made phenomena and can be 
prevented--they are created through public and medical malpractice 
which result in intermittent or ineffective TB treatment.
    The U.S. is proof that tuberculosis can be managed. During the 
1980's we ignored TB in this country and beginning in 1989 we 
experienced mini-TB epidemics in our large cities. We responded by re-
building our TB control programs and our TB rates are again falling at 
about 6 percent a year. But we are a well organized, well funded 
country.
    Can this be done in poor countries? The answer is a resounding yes.
    A small but dynamic unit at the World Health Organization--The 
Global Tuberculosis Programme--has not only redirected world wide 
attention to TB--but has actually come up with a control strategy that 
works in poor countries.
    Their program is simple, cost effective, doesn't require big 
bureaucracy and most importantly, it cures people. They call it DOTS--
``directly administered treatment--short course''--similar to DOT in 
this country but with a simple management system which even the poorest 
countries can use to prove they are making progress.
    The program can work in any health care system--it has been proven 
effective everywhere from New York City to China--but requires that the 
patient be directly observed whenever taking their TB drugs--thereby 
minimizing the potential for premature discontinuation of treatment and 
at the same time, leaving no chance for the development of drug 
resistant organisms.
    This small WHO unit has already convinced 70 of the world's 216 
countries to begin using this DOTS TB control strategy--these nations 
encompass 23 percent of the world's population, but the DOTS approach 
has not yet been spread to all who need it in these countries.
    In New York City where the U.S. DOT program has been instituted, 
new TB cases have fallen 46 percent and new drug resistant cases have 
dropped 82 percent.
    In only 4 years, in 9 TB epidemic countries, 1.2 million TB cases 
have been entered into the WHO DOTS programs and 85 percent of them 
have been cured compared to less then 40 percent cure in areas where 
the DOTS program is not being used.
    WHO has documented a 95 percent cure rate in China where over 
90,000 new infectious cases were treated with DOTS in 1995. Over 
150,000 infectious cases were under DOTS treatment in 1996 and will 
show similarly high cure rates.
    Similar cure rates have been documented in Bangladesh, Nepal, Peru 
and parts of Africa, and small areas in Indonesia and India, where DOTS 
programs are starting.
    On the other hand in Russia where the DOTS program has not been 
implemented, the number of TB cases has grown from 50,000 in 1991 to 
85,000 in 1995. I would predict that drug resistance rates in that 
country are also soaring as they are in Latvia and Lithuania, where the 
prevalence of multi-drug resistant TB is already above a terrifying 10 
percent level.
    Overall, sadly, and frankly inexcusably, as a result of too little 
being done too late by those with the money and power to act, only 10 
percent of the world's population suffering from active tuberculosis is 
being treated with DOTS right now. While this is an enormous advance 
from just a few years ago, it is grossly inadequate and definitely not 
in U.S. national interests.
The U.S. can make a difference
    The U.S. can make a difference. And not just by spending more money 
in the U.S. At this point in time, the U.S. is basically in control of 
its TB problem. It must have the same impact throughout the world or 
the TB problem will return to our shores.
    We should insist that the World Health Organization leadership 
place TB control and the use of the DOTS strategy near the top of its 
priority list and insist that it support this priority with more of its 
own WHO funds.
    We should urge multi-lateral institutions like the World Bank to 
devote at least 5 percent of their lending towards controlling 
infectious diseases--with an appropriate emphasis on tuberculosis--and 
this commitment should be at least for the next two decades. This is 
not an esoteric illness, it has real economic implications. Remember, 
TB hits the working age group--the economic base of a developing 
country.
    We need the strength and leadership of the USAID to really focus on 
TB itself--not just as a complication of HIV/AIDS. USAID should be in 
front of good global tuberculosis control, not behind. This is 
something America can do that is good for the world and good for 
America. Not many foreign assistance programs can draw such a 
connection.
    And, we should commit some of our own money to advance a unified 
worldwide TB control program by financially supporting WHO's Global TB 
Programme (which functions in the same way as our CDC TB Elimination 
Division) and by supporting the division's NGO partners--for example: 
the International Union Against TB.
    Simply put: We need to expand the worldwide implementation of the 
DOTS strategy.
    Finally: As has been noted by previous speakers, we are going to 
need funding for additional research--there's no doubt about that. But 
right now we already have the tools to save lives today. If we properly 
treat someone with TB today, they will begin getting better tomorrow 
and we will have prevented the disease from spreading or worse yet, 
mutating into a potentially incurable drug-resistant form.
    What we really need is the will, the commitment, and the leadership 
to get the job done.
    If we don't, we'll see a continuation of what presently exists--too 
little, too late, and too timid--and the result is an epidemic that 
threatens us all.

                               seed money

    Senator Leahy. Using it as seed money, how do you choose 
where to plant the seed?
    Dr. Sbarbaro. The country has got to be interested. You 
have got to convince it that, No. 1, it is a problem. And 
that--you know, as soon as a government realizes that even the 
elite are not protected--you know, I have got somebody who 
helps me in my home. Is that person coughing? Well then, your 
kids and you are at risk. It suddenly becomes very apparent 
that this is a disease that knows no class, it is not 
economically based, although it is spread in poorer areas, as 
Dr. Bloom pointed out. But those poor areas mingle with 
everybody.
    They have been able to convince 70 countries to start. Once 
you start that, the economic advantage both to the country and 
the reduction in disease burden helps.
    All these folks are going to bring this disease into our 
country. We have a real--we really have got something at stake 
here. To help them is to also help us, and I think that has 
been made by all four of my colleagues.
    Senator Leahy. So much of this is interrelated. It is 
caught up in everything from civil wars and the mass movement 
of refugees that we see in Rwanda, to a chaotic society like 
Nigeria today.
    Earlier this morning I was speaking to a group about 
antipersonnel landmines, and the effort that I have been 
involved in and so many others have been involved in around the 
world, to ban antipersonnel landmines.
    I recall where we used the Leahy War Victims Fund to 
provide prosthetics for victims of landmines in Uganda. I was 
there with my wife, Marcelle, Tim Rieser, and others. We were 
looking at people who had been injured by landmines, and my 
wife was helping one of the medical people with a young child, 
to bathe him and dress him. He was horribly crippled.
    We asked the translator, what had happened? It was from 
polio. She was saying to me afterward: Do we not--for God's 
sakes, polio is so easy to get rid of. Do we not have a 
program? Do we not give them money? Do we not help? It turned 
out we did. But the people who had to administer the vaccine 
could not get to the village because of the landmines.
    So this little boy never stepped on a landmine, but he was 
crippled as much as if he had.
    The reason I asked the question of how you pick the seed or 
where do you plant the seed, is there enough stability, so that 
WHO or AID or anybody else can operate there?
    We have this problem even here at home. My kids are growing 
up, just out of law school and struggling to make ends meet, 
like everybody else. But you just assume of course--the kid is 
coming along, the pediatrician says you come in at such and 
such a time and you get these shots, and you come in, you just 
do it.
    But now we are finding even in our country, where there are 
programs and everything else, people are not doing it.
    Dr. Sbarbaro. To give you some hope, Senator, I have to 
point out we did this in New York, and if you can do it in New 
York you can do it anywhere. And we actually cut the rates down 
by 45 percent.
    Senator Leahy. Well, let us say that--we do not have all 
the money in the world, but let us say--well, actually we do 
have all the money in the world. We just do not want to spend 
it. [Laughter.]
    But let us say we had an additional $50 million a year for 
5 years to devote to this problem. What would you do? I ask 
anybody in the panel who wants to answer. Do you try to wipe 
out one or two of the priority diseases, or do you build the 
infrastructure to be able to identify and contain diseases 
before they become epidemics? How would you use the money? Dr. 
Bloom?
    Mr. Bloom. I do not see those as alternatives. I think you 
have to do both, and you have to ask where you get the most 
return. I think that one of the places you get returns from is 
knowledge, public goods. There are programs at WHO that deal 
with infectious diseases that I think do an extraordinary job 
of not only acquiring knowledge and transmitting it to 
developing countries, as you heard in the TB program, but they 
actually show that they can work.
    An example is when it was proposed that we vaccinate all 
the world's children, all the wise people figured that could 
not be done: too expensive; how are we ever going to get it out 
there? Well, in 1992--I can tell you what the 1992 figures were 
very well. Some 80 percent of the kids in the world got 
vaccines, and 36 percent in New York. So we can get vaccines 
out there and, as you know, to wipe it out in the hemisphere.
    That happened because it was done in a single country and 
shown to work. So if it is done and done well, it has an 
impact, creates a competition, and other countries will want 
it.
    WHO extra-budgetary programs, the tropical disease research 
program, for example, on malaria; the United Nations AIDS 
Program on setting up areas to test vaccines in AIDS that will 
be as important to us as it is to the people in those 
countries; the emerging infectious program of David Heymann to 
link surveillance centers around the world. These will provide 
vast knowledges, amounts of knowledge that countries can use, 
and then to target those that are willing to use them through 
AID to actually get it done.
    Thank you.
    Senator Leahy. If I could just follow up on that, Dr. Bloom 
and maybe with Dr. Heymann. You have got an organization, WHO, 
and one of the ones you hear, is that you have 200 bosses--the 
member countries and Dr. Bloom from country A has this 
priority, Dr. Daulaire from country B has another priority, and 
on and on.
    WHO tries to do everything because everybody wants you to 
do everything. But don't you have to do some kind of a triage? 
I mean, if there are six or seven diseases that cause 70 
percent of the deaths, is it not better to go after those six 
or seven diseases, even if it means others are left out?
    Of course, if you are part of the ones with that disease 
No. 9 or 10 that has only 5 percent, but you are in that 5 
percent, that is the one most important to you. How do you do 
this?
    Dr. Heymann. Thank you for that question. I think first of 
all, I think the number of countries that belong to WHO, 
essentially all countries in the world, are a reinforcing 
factor for such underlying activities as we are trying to 
develop now, which is stronger surveillance and control within 
countries.
    What I have shown you in my briefing paper is that WHO is 
setting up a framework which meets the needs of countries in 
the north which want to contribute to the south. It sets up a 
framework where they can work bilaterally, and it also 
strengthens underlying surveillance and control activities.
    Each country does have different priorities. Each country 
must address these priorities. But they can address them with 
certain generic things, as Dr. Daulaire said also, 
strengthening those surveillance systems and detection systems 
and control systems, so that the health care system is 
available and able to do what is necessary to fight the local 
priority diseases.
    It is true that WHO at headquarters has a diverse program. 
WHO is refocusing. I am pleased to tell you that 12 percent of 
budget in the next biennium will be reallocated to what our 
executive board has said are priority programs, which includes 
infectious diseases.
    We have tried to estimate a budget for the next 2 years of 
what WHO would need to set up this surveillance network, so 
that we would have a framework which would include the global 
monitoring and alert systems, the laboratories in countries, 
global information access electronically, national and regional 
strength in surveillance and control, that underlying 
preparedness to face, detect and face epidemic diseases and 
routine infectious diseases such as AIDS, diarrhea, and 
malaria, and finally an international preparedness that will 
make sure there are enough vaccines, that will make sure there 
are enough drugs which are necessary to take care of these 
programs.
    We have estimated $26 million in 2 years to set up the 
framework. That framework then permits USAID, the European 
Union, United States Task Force, the European-Japan Common 
Agenda on Emerging Diseases, to build within that framework 
bilaterally to strengthen global surveillance and national 
surveillance and control.
    Thank you.
    Senator Leahy. Dr. Daulaire, what would you do with that 
$50 million?
    Dr. Daulaire. Well, let me answer your question in two 
parts, Senator Leahy. First, the issue that we have been faced 
with repeatedly over the past 4 years has been that the 
Congress has come to us with money for specific reasons--polio 
eradication is one example--but it has been one of these shell 
game procedures in which we are given the money, but that money 
then is removed from the rest of our budget. So my first plea 
would be, if we were to get $50 million----
    Senator Leahy. Make it a real $50 million.
    Dr. Daulaire. Make it real, that is right. Do not just put 
it underneath everything else.
    Second, what we have also found is that the more we get 
micromanaged--you have to spend it on--for instance, going back 
to the polio initiative, the first legislation for that stated 
that we could only use that money to purchase polio vaccine. 
With all due respect to my colleague on the left who produces 
vaccines, this is not where we had a comparative advantage, nor 
was it where the greatest need was in terms of the polio 
eradication effort worldwide. And we discussed it with the 
Congress and were able to get that lifted.
    I think the key issue needs to be to focus on where we are 
going to have the major impact, broadly speaking, on public 
health. So the third part of my response would be, if you were 
to give me $50,000 today personally and ask me to invest it, I 
would not put it all in Microsoft. Maybe I should, but I would 
not.
    Senator Leahy. No; you would have done that 15 years ago.
    Dr. Daulaire. That is right.
    But what I would do and what we would do at AID is to put 
it into a portfolio. We would be looking for some things with 
short-term quick returns--eradication efforts in specifically 
targeted diseases where we could get a quick bang for the buck. 
We would be putting some things into longer term payoffs, such 
as research, moving the technology forward. And we would be 
putting most of it into the application of existing technology 
in disease control programs.
    I think that TB, as Dr. Sbarbaro has said, is really the 
key unresolved issue in public health in the world today. We 
could certainly do more in that area. We would have to do it 
through the strengthening of health systems and integrating it 
into the systems that are already there.
    Senator Leahy. Dr. Douglas, would you like to add to this?
    Mr. Bloom. Yes; I would. I think you have heard that you 
could do a lot in terms of building up infrastructure with a 
fairly small amount of money, and I think that I support what 
Dr. Daulaire and others have said, is that you really should 
not try and micromanage this, but rather let the experts make 
sure that the money is going to the most important diseases and 
ways of handling the most important diseases, whether it is--it 
may well not be purchase of medication. It may be setting up a 
structure in which that can be used, which was my Mectizan 
story.
    Let me give you another example of something that is 
needed, and that is epidemiology. That is the study of a 
disease in a population, whether or not it exists. We have 
developed, as have several other companies, a vaccine which is 
called a HIB, vaccine, which is now one of the routine vaccines 
administered to children in the United States and Western 
Europe. It has virtually eliminated childhood meningitis in 
this country in the 1990's. It is one of the medical miracles 
of the 1990's and you never hear about it. It is an amazing 
achievement.
    It is not available in most of the poorer countries of the 
world. A study was recently done in Gambia which showed that 
not only was meningitis eliminated from these kids, but a 
significant segment of pneumonia. And if you remember Dr. 
Bloom's pie chart, that acute respiratory disease in childhood 
is one of the three or four largest killers in the world.
    We need to understand whether that problem exists 
worldwide. If it does, you have today a vaccine infrastructure 
worldwide that immunizes 80 percent of the world's kids with 
all the appropriate vaccines. HIB could be added to that for a 
very low cost to the world, or to the United States or 
something. We are not talking about megadollars to do that, and 
that would be a wonderful achievement if the epidemiological 
base for going forward was there. And the epidemiology could be 
done for a very small amount of money, and it is not being done 
today.
    Dr. Sbarbaro. Senator, I noticed you looked at me, but one 
aspect of a wise person is to know when he has got real 
expertise on his right. I am not going to second-guess Daulaire 
and Heymann, no way.
    If you could nooge them to take care of TB a little bit 
more, I would sure like their expertise, though.
    Senator Leahy. I think of some of the things that happen in 
this country. You go and get your sprained ankle taken care of 
in a hospital and you end up with some kind of an infection, 
staph infection or something else, resistant to penicillin. I 
see more and more resistant infections, and I also see that we 
are using more and more antibiotics for a whole lot of things. 
They pass them out like chewing gum in some places. We add them 
to animal feed all over the world.
    Are we creating our own monster?
    Dr. Sbarbaro. Yes.
    Dr. Douglas. Of course. Yes; we are. I will take at least a 
first crack at that. There is no question that the widespread 
use and overuse and abuse of antibiotics is one of the reasons 
for the emergence or the rapid emergence of resistant strains. 
It has happened with viruses, it has happened with bacteria. It 
is going to happen with the AIDS drugs. It is a natural 
phenomenon.
    There are certain settings in which it occurs. If you 
inadequately treat, underdose, patients, give small doses of 
drugs or skip doses, that is a situation in which emergence of 
resistance will occur.
    What is the ultimate solution? One of the ultimate 
solutions that everybody always jumps at is we should invent 
more drugs. It is harder and harder to invent new antibiotics 
and it is a very expensive process.
    Another solution is to develop vaccines so that you do not 
even get these infections in the first place. The example of 
streptococcus pneumonia, for example, is a wonderful one. It 
was mentioned earlier by one of our speakers, the major cause 
of pneumonia. There is a vaccine for older persons which will 
prevent pneumococcal infection and in development for younger 
persons, again, a vaccine that could be used worldwide will 
prevent the occurrence of that infection, and then you do not 
have to worry about the emergence of antibiotic-resistant 
strains.
    Dr. Daulaire. Let me add to that, Senator. Mistreatment and 
inadequate treatment are at the root of the widespread 
development of antibiotic resistance. Throughout the developing 
world today you can go to almost any street stall pharmacy and 
purchase almost any pharmaceutical product, certainly almost 
any antibiotic. The common way in which illnesses are treated, 
and often it is the common cold, is with a day or two of an 
antibiotic, because it is readily accessible in that context 
and it is reasonably inexpensive. People go and they use their 
own money for it.
    Often it is promoted and enhanced by poorly trained 
physicians in these countries. I have actually seen this in our 
own country, so it is not restricted to the developing world, 
where people make hip-pocket decisions on treatment. And again, 
a poor patient who has to shell out money for a drug, they may 
be able to buy a few days supply, but very often what they will 
do is they will save--once they are starting to feel a little 
bit better, and this is particularly true with TB, they will 
save their medicine for another time.
    This is an enormous contributor. And what we have found in 
our programs--I cut my teeth in a field trial on treatment of 
childhood pneumonia. What we found is that it took real 
assiduous followup with patients to make sure that they took 
their entire course of antibiotics. That is how you both treat 
the disease effectively and prevent the development of 
antibiotic resistance among the organisms.
    Senator Leahy. Yes?
    Dr. Heymann. Thank you, Senator.
    I would just like to add that it is not only a problem in 
developing countries, misuse of antibiotics; in countries like 
the United States and Canada as well. Canada just published an 
article in ``The Lancet,'' a well known medical journal, 
where--I cannot quote the exact figure, but between 30 and 40 
percent of antibiotics were used when they should not have been 
used. It happens in this country as well for influenza, because 
a patient demands an antibiotic when he sees or she sees a 
physician. Physicians and others must educate the public that 
antibiotics are not always indicated.
    I would like to just address also the issue of antibiotic 
resistance in animals, because this is an issue which must be 
studied more. What we do know is that antibiotics are used 
increasingly in animal husbandry. And if you look at a graph, 
for example, of salmonella in the Netherlands, an organism 
which causes typhoid, you can see it is a normal inhabitant in 
certain animals, and you can see that resistance to antibiotics 
is increasing in those animals.
    If you look at resistance of the same organisms in the 
human population, there is a parallel increase in resistance. 
Now, these are not necessarily linked, but they are 
circumstantial evidence that there is a parallel increase in 
resistance in both animals and in humans which are infected 
with organisms which also infect animals. Now, bacteria have a 
means of transferring resistance from one to another outside a 
human body. So this may be occurring in the environment or it 
may be occurring within animals and then transferred to humans.
    But there is a parallel increase in the Netherlands which 
shows clearly the same trend in human and animal infections of 
one organism.
    Senator Leahy. What about, you talk about a global system 
for surveillance and control. If that had been in place, 15 or 
20 years ago, would we have identified an AIDS epidemic, No. 1? 
No. 2, is it conceivable that it could have been isolated?
    Dr. Heymann. I would like to take a crack at that, Senator. 
In the first ebola outbreak in 1976 in Zaire, specimens were 
collected from villages around the outbreak site, many, many 
blood specimens. These were stored at CDC. Some 10 years later 
when there was a test for HIV and when HIV had been recognized, 
because in 1976 it was not yet recognized, but 10 years later 
those bloods were screened for HIV, and already they had a 
level of HIV of 1 percent of HIV in 1976.
    AIDS was a rural disease in Africa which was not spreading. 
We know it did not spread greatly because 10 years later in 
1986 when those bloods were screened that had been collected in 
1976, bloods were also collected again from those same 
villages. HIV remained 1 percent.
    What happened to HIV was, it was not recognized in rural 
areas of Zaire or other places where it was occurring. It got 
into major metropolitan areas, where behavior encouraged an 
amplification of that disease, and the disease amplified and 
spread worldwide.
    If there had been systems which could have detected 
something unusual even in 1 percent of the population in 1976, 
we may have been able to understand that there was a disease 
which was present, which maybe was present, many, many years 
before that and which could be contained. So I think the answer 
is strong surveillance systems in countries can help to 
identify diseases early and permit a response and possibly 
containment where they are occurring.
    Dr. Daulaire. Let me add, Senator, there is no question but 
that early identification would have had a considerable impact 
on the dynamics of the HIV-AIDS pandemic. I also very much 
doubt that we could have contained it at that point. By the 
time that HIV began its incursions into Asia, we knew about the 
disease very well. We had good tracking mechanisms, and that 
has certainly helped to slow its spread, although Asia is today 
the site of the largest number of new infections of HIV per 
year in the world, surpassing Africa.
    What we could have done by an earlier detection and by a 
better surveillance mechanism was to change the dynamics of 
this epidemic, slow it and give us more time to get it under 
control rather than letting it get out of control, as it has.
    Senator Leahy. Let us take a situation closer to home. In 
September 1995 the New York Times stated, ``There is a new 
virus attacking thousands of people less than 10 miles from our 
borders. Yet we greet this nearby epidemic with an eery 
silence.'' They were talking about dengue.
    Then look at some other numbers I have here: Nicaragua, 
35,000 cases of malaria, 17,000 cases of dengue, 2,000 cases of 
dengue haemorrhagic fever.
    I look at cities like New Orleans or Houston, where you 
could replicate some of the situation that might raise that. 
Now, does this strike us as something where AID should put up 
our first line of defense, or who does? Or are we? Maybe we 
are?
    Dr. Daulaire. We are in fact involved in this. I should 
mention, Senator Leahy, that I personally had dengue fever, if 
not the dengue haemorrhagic fever. It is an unpleasant thing to 
have, but I had a mild case.
    Senator Leahy. Somebody described it to me, they call it 
the broken bone.
    Dr. Daulaire. Break-bone fever.
    Senator Leahy. Break-bone fever.
    Dr. Daulaire. Mine did not break.
    Senator Leahy. But it felt like it did?
    Dr. Daulaire. Oh, yes.
    First of all, we have to recognize, AID actually is 
spending about $1 million a year strengthening programs in 
Central and South America dealing with dengue fever. So yes, we 
do have a response.
    On the other hand, is this one of the leading public health 
challenges in the world today? We think it probably is not. 
There are about 200 people--I mentioned earlier 17 million 
people die of infectious diseases around the world. About 200 
die of dengue haemorrhagic fever in Latin America each year.
    Now, that does not minimize the problem. There are hundreds 
of thousands who get infected annually and it has the potential 
to become a real problem for us as well. So our approach is to 
deal with environmental issues, because it is a mosquito-vector 
disease, and also to deal again with the health systems, 
because with proper case management the case fatality, the 
number of deaths for every 100 cases of dengue haemorrhagic 
fever, is less than 1 percent. So it is something that can be 
dealt with at the health systems level without this enormous 
case fatality.
    Senator Leahy. Well, let us take one that many people are 
more apt to get, and that is malaria. There are one-quarter of 
a billion people contracting it each year and a couple million 
people dying of malaria. I remember on a trip to Africa taking 
some malaria prevention medicine which had such terrible side 
effects that one of our pilots became suicidal, not the sort of 
thing you want to have happen to the pilot of your airplane. 
You want pilots to have a good attitude toward life and a 
strong sense of self-preservation, especially as they are 
landing at about 200 miles an hour.
    My wife became sick and we realized it was the medication. 
She stopped the medication and was fine. I see Dr. Denis 
Carroll here, who works with malaria at AID.
    I have seen these mosquito nets. They are insecticide-
impregnated mosquito nets. I am told they cost about $5, which 
for those of us in this room is nothing, but in many parts of 
the world you want to use it the $5 is an enormous amount of 
money. Do we have a program to get these things to people who 
need them? Second, if we start making enough of them does the 
price go down? Third, are we ever going to see a vaccine for 
malaria? That's three questions.
    I bet you are glad you are here.
    Dr. Carroll. Thank you, Senator Leahy.
    Actually, I am glad I am here. And it is worth noting that 
particular bednet you have there comes from a program that AID 
has carried out in central African republic. What is worth 
noting about the bednet is that it is a technology which, with 
impregnation using insecticides for treating that netting 
material, the World Health Organization over the last several 
years has shown dramatic impact on the health and well-being of 
children in sub-Saharan Africa.
    In large portions of the areas that have been tested, 
survival rates of up to 30- to 40-percent reduction in child 
mortality by appropriate use of the bednet. You however point 
out one of the real problems associated with the bednet, and 
that is the cost, $5. And that is $5 for a single net, and we 
do know from the studies that we have done and from our field 
experience that you are likely to have to deal with three or 
more nets per household. So you are talking about a much larger 
bite out of the personal income of families. And on top of 
that, you are talking about a recurring cost of about $1 to $2 
a year for retreating that net with the insecticide.
    So it is not free and it is not certainly an easy economic 
challenge to the populations. We do not have the answer right 
now as to how you deal with that. We are concerned about the 
high cost.
    We are right now supporting and beginning to undertake the 
first large-scale voluntary use programs in Africa in two 
African countries right now, and we are hoping to, through 
these experiences, better understand how to address the issue 
of affordability, among other possible problems associated with 
it.
    Senator Leahy. This is an area where private industry could 
come in and help, too.
    Dr. Carroll. I can note that in these areas where we are 
working we have the benefit of a partnership with Bayer, which 
is, in much the way that Merck has made Mectizan available for 
purposes of the onchocerciasis control activities in Africa, 
Bayer is joining with us in making available the insecticides 
that we need in order to move forward with these trials right 
here.
    So that we are exploring, we are testing how we can work 
with the private sector and how we can create appropriate 
private-public sector partnerships to address the issues of 
affordability.
    Senator Leahy. Unfortunately, I have to leave for a meeting 
with the President at the White House, who is then going to be 
in about 30 minutes up here on the Hill.
    I have many more questions. I look at some of the facts 
that staff prepared for me in getting ready for this. They 
talked about after the collapse of the Soviet Union the public 
health system fell apart. I guess by 1995 there were 25,000 
cases of diphtheria, 5,000 people died.
    Diphtheria is something we have had a vaccine for, I do not 
know, certainly all my lifetime, I guess most of this century. 
So it disappears, and then you let down your guard, and, boom, 
it is right back there again.

                     additional committee questions

    Could I suggest this to each of you. You could probably 
think of more questions than I could. If there are further 
items that you think we should have covered but did not here, 
further thoughts you have--all your statements will be part of 
the record--send them to me, and we will include them in the 
record.
    We do not think of these things affecting us, but I hope 
that everybody who has listened today realizes there is nobody 
in this room who is immune from the issues we are talking 
about. We may be immune from river blindness as Americans, but 
we are not immune from many other diseases. I said before that 
we have a moral responsibility on river blindness.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
                Questions Submitted by Senator Campbell
                              tuberculosis
    Question. Rates of Tuberculosis infection are extremely high among 
the poor in developing countries, but the United States also has its 
share of cases. Wherever people are impoverished, lacking proper 
medical care and living in overcrowded conditions, the disease may be 
found.
    Frighteningly, the strains of TB found today are becoming 
increasingly drug-resistant. Medical costs to cure tuberculosis 
skyrocket once resistant strains emerge. The cost of treating a TB 
patient in the United States can jump from several thousand dollars for 
outpatient treatment to $250,000 to treat multi-drug resistant TB.
    (A) In what ways can we seek to ensure that U.S. foreign aid 
funding used to fight tuberculosis is having the most on-the-ground 
impact in the countries with high incidence of TB?
    Answer. USAID has sought to ensure that the funds available for 
tuberculosis programs are used most effectively. The majority of funds 
($7.5 million) have been allocated to purchase infant BCG vaccine 
(Bacillus-Calmette-Guerin), which minimizes the complications and 
shortens the course of pediatric tuberculosis. USAID has also supported 
operations research and evaluations of national TB control programs to 
determine the most cost-effective methods to accurately diagnose and 
treat patients. This research has helped to identify a broad range of 
health providers (in addition to hospital-based physicians) who can 
care for patients in remote and underserved areas. USAID is also 
developing a CD-ROM-based interactive computer program to optimize TB 
case management. By increasing the number of providers capable of 
providing care to tuberculosis patients, standardizing and streamlining 
optimal training of providers, and ensuring the availability of 
services to those in need, USAID hopes to improve and shorten the 
course of treatment of TB patients, and maximize resources so that more 
patients can be appropriately treated.
    Additionally, USAID works to maximize the on-the-ground impact of 
efforts to fight TB through our health systems development and 
strengthening programs, which represent about 9 percent of our health 
care budget. While we do not ``count'' this funding as TB-related since 
it impacts the control of virtually all major public health problems, 
our efforts in system strengthening mean that the more closely targeted 
TB efforts have a chance of succeeding where they otherwise would not.
                             immunizations
    Question. Immunizations are a simple and cost effective way to save 
children's lives--it costs as little as $17 to immunize a child for 
life against measles and five other deadly diseases.
    Reports indicate that the United States could save millions of 
dollars in treatment and prevention costs if these diseases were 
completely eradicated around the world. For example, the total amount 
of external aid needed for a five year period to eradicate polio is 
approximately $130 million per year. Reports indicate the U.S. alone 
could save twice that much a year once the virus is eliminated.
    (A) Can you talk a little about the progress that has been made in 
terms of vaccinating against easily preventable diseases, and how much 
more still needs to be done?
    Answer. Globally, today, immunization rates approach 80 percent, 
compared with only 44 percent in 1985 when USAID launched its Child 
Survival Program. In many USAID-assisted countries, immunization rates 
are even higher. A 1995 survey in Honduras, for example, showed that 94 
percent of children less than one year old were vaccinated for all 
immunopreventable diseases (measles, polio, DPT, and BCG) by 1993. 
Worldwide, an estimated three million lives of children are saved 
annually as a result of immunization against childhood diseases, and 
one half million cases of polio are avoided.
    In 1994, polio was officially declared eradicated in the Western 
Hemisphere. USAID, the largest external donor to this effort, 
concentrated particularly in the poorest countries such as Bolivia and 
Haiti where vaccination rates lagged seriously behind those across the 
rest of the continent. Worldwide, as coverage rates have doubled over 
the past decade, polio cases have been cut by two-thirds. USAID's new 
Polio Eradication Initiative is now focusing on sub-Saharan African and 
South Asia.
    Since more than 100 million infants a year need immunizing, much 
remains to be done, particularly in Africa where immunization coverage 
averages under 50 percent. Although immunizations are an effective and 
efficient tool for saving children's lives, access to health care is 
still difficult for rural populations in many of the least developed 
countries. For example, delivering immunizations on a sustainable basis 
is problematic in the middle of the new Democratic Republic of the 
Congo. USAID is working with both public and private sector systems to 
strengthen immunization systems and their outreach in such situations. 
Certification of a ``polio free'' developing world (notably Africa) is 
especially challenging. With that in mind, we need to be prudent in 
anticipating the ``eradication'' or ``elimination'' of other diseases, 
such as measles.
    (B) How can we best ensure that our investment results in programs 
which reach poor people in their communities and programs with the 
highest possible impact? What are your views on current ways to measure 
the impact of these programs on-the-ground to be sure we are investing 
wisely and effectively?
    Answer. USAID has focused its efforts on reaching the poor in 
developing countries. We work with grassroots organizations such as 
NGO's to deliver rural services. We work with governments on policy 
reform to shift resources and attention to basic care and prevention. 
We work with our donor colleagues to help build systems which reach the 
poor, strengthen management and referral capabilities, and which help 
assure sustainability.
    USAID promotes impact monitoring and evaluation in all of its 
projects. We work with host country governments and NGO's to develop 
monitoring and evaluation systems designed to track indicators at the 
grassroots level, such as children immunized, persons receiving 
``quality care,'' women understanding how to recognize infection, and 
people knowing when to immunize their children.
    (C) One hundred million infants per year need immunizations. Can 
you tell me a little about the progress made in vaccine self-
sufficiency on the part of developing countries?
    Answer. Significant improvement has taken place in the number of 
countries that are now paying for all or part of their vaccines. At 
least 20 developing countries are now paying their entire vaccine bill. 
Fifteen more pay more than half of their own vaccine costs. But in many 
of the least developed countries, host country resources cover only 5 
to 25 percent of the costs of their total vaccine needs.
    To promote vaccine self-sufficiency, USAID is working with host 
countries to strengthen their capabilities to (1) issue tenders to 
procure vaccines competitively on the international market; (2) 
regulate vaccine quality at the national level; (3) improve vaccine 
handling and delivery; (4) improve and introduce more efficient 
schedules for vaccination; and (5) reduce vaccine wastage. This 
strategy--which focuses on strengthening the capacity of local 
governments and non-governmental organizations--is one of the main 
reasons for the continued high immunization coverage levels in most 
developing countries since 1990.
    Vaccine self-sufficiency is, however, a multi-faceted goal. USAID 
has directly promoted vaccine self-sufficiency by helping host 
countries develop strategies for reducing waste and inefficiency. For 
example:
  --In Krygystan, changes in vaccination guidelines and practices 
        between 1995 and 1996 reduced wastage of DPT vaccine by almost 
        50 percent;
  --Introduction of vaccine vial monitors, which indicate whether 
        vaccines exposed to excessive heat and therefore possibly 
        damaged are still effective, have helped to reduce wastage of 
        oral polio vaccine by up to 30 percent, saving an estimated $10 
        million a year globally;
    Implementation of improved schedules for immunization in the five 
Central Asian Republics is estimated to save $1 million a year.
                    vitamin and mineral deficiencies
    Question. Deficiencies in essential vitamins and minerals can lead 
to blindness, mental retardation, physical deformities and even death. 
Yet treatment of these deficiencies can be simple and inexpensive.
    (A) Among the most cost-efficient interventions available is the 
administration of vitamin A, either orally or through fortified foods. 
Can you tell me more about efforts underway in this endeavor? How can 
we help to ensure that the limited foreign aid funding for vitamin A 
programs is actually used as appropriated?
    Answer. USAID is spending more than $20 million annually on 
interventions to address micronutrient deficiencies in populations in 
need. More than one-half of the Agency's sub-earmark for micronutrients 
is spent to reduce vitamin A deficiency.
    USAID-supported research was key in proving that vitamin A improves 
child survival dramatically, by 20 to 30 per cent in deficient 
populations. USAID has agreed to ``push the envelope for vitamin A 
delivery to children in need.'' Over the next five to seven years, we 
will focus our efforts in three to four countries where vitamin A 
deficiency is a problem and where we believe that U.S. government 
resources can make a real difference to child survival. We will also 
coordinate with our bilateral and multilateral donor colleagues to 
promote and deliver vitamin A to vulnerable populations.
    We are presently helping to fortify foodstuffs in Bolivia (sugar), 
Guatemala (sugar), El Salvador (sugar), Sri Lanka (flour), and 
anticipate supporting future fortification efforts in Zambia and the 
Philippines. These activities will dramatically improve vitamin A 
sufficiency in needy populations and are expected to improve child 
survival dramatically.
    Use of Funding: By working with public and private sector entities 
on fortification efforts, we are helping to create an internal market 
which will improve distribution and limit inappropriate use of U.S. 
government resources. Public-private partnerships, which are built on 
the local economy and focus on creating local demand, are self-
sustaining. Vitamin A fortification, along with iron and iodine 
fortification of foods can help to foster widely sustainable ways of 
reducing micronutrient deficiencies.
    (B) What types of efforts are underway to add vitamin A to foods 
that are regularly traded to the developing world?
    Answer. At present, USAID is not exploring efforts to fortify foods 
that are traded to the developing world. Our approach is to focus on 
locally produced foods and add fortificants appropriately so they will 
be routinely consumed by the local population, and thus be a more 
sustainable effort.
                                aids/hiv
    Question. AIDS/HIV is one of the most frightening of the new 
diseases encountered in the last 20 years. The rate of infection among 
developing countries is staggering; everyday more than 6,000 new people 
are infected, half of whom are adolescents. The disease is rapidly 
spreading to the heterosexual population, with new infections 
concentrated in 15 to 25 year olds.
    (A) What is the best way for the U.S. to efficiently utilize global 
AIDS funding to prevent the further spread of this terrible virus, both 
at home and abroad?
    Answer. USAID, working closely with host country governments, 
indigenous NGO's, the private sector, and the international donor 
community, has been the world's leader in developing state-of-the-art 
prevention interventions, and is the world's largest donor to this 
effort. In the past year, USAID, in collaboration with its partners, 
has redesigned its portfolio to respond to the growing and changing 
worldwide epidemic. This has resulted in an expanded strategy which 
will incorporate successful programs developed over the past several 
years, as well as strategies which address new and developing aspects 
of the epidemic such as the surging tuberculosis, childhood mortality 
and orphan rates. This expanded response will focus on:
  --(1) Field support to missions (technical assistance, training, 
        materials production, support of communication campaigns and 
        delivery of STI clinical services) to implement interventions 
        which reduce sexually transmitted infections and high risk 
        behaviors.
  --(2) Field support to missions to implement condom distribution 
        interventions for HIV/AIDS prevention and control.
  --(3) Identification, refinement, and improvement of ``best 
        practices'' through operations research, field testing of 
        program interventions, and the review of scientific studies and 
        publications.
  --(4) Field support in the design, monitoring, and evaluating of 
        programs; collection and dissemination of technical lessons 
        learned to field missions, cooperating agencies, governments 
        and international donors to ensure the understanding and use of 
        successful strategies.
    USAID will also support activities to establish and improve HIV/STI 
surveillance systems, build local PVO/NGO capacity, conduct selected 
biomedical research (specifically to support the development of a 
vaginal microbicide, inexpensive STI diagnostics, and potentially to 
adopt a proven vaccine for use in resource-poor settings). We will also 
provide technical assistance and operations research to assist Missions 
in the development of rational, strategically sound basic care 
alternatives for HIV infected persons and support for the survivors 
which would enhance their prevention goal, promote policy dialogue, and 
support UNAIDS and the six cosponsoring agencies of the United Nations.
    To maximize the impact of these primary prevention interventions, 
USAID's revised strategic approach will insure that:
  --(1) the most appropriate countries, settings, and vulnerable 
        populations are reached;
  --(2) the number of beneficiaries of behavior change and STI 
        interventions is increased;
  --(3) programs focus more closely on how to renew and refresh 
        behavior change interventions to maintain long term behavior 
        change for safer sex practices;
  --(4) partners at country level (mainly indigenous NGO and CBO's who 
        perform the bulk of the most effective interventions) 
        collaborate closely to increase technical and management 
        capacity, and ultimately achieve autonomy and long term 
        sustainability.
    (B) What measures have been shown to be most effective and cost-
efficient in educating people and preventing the spread of HIV in 
developing countries?
    Answer. More than 70 percent of HIV transmission is through 
heterosexual contact. USAID's strategy, therefore, focusses primarily 
on preventing sexual transmission. Over the past five years, the 
effectiveness of the three primary interventions to reduce sexual 
transmission, cited below, has been dramatically proven:
  --(1) Reducing the prevalence of other sexually transmitted 
        infections. In Tanzania and Malawi, studies have documented a 
        42-percent decrease in new HIV infections after the 
        implementation of proper clinical management of sexually 
        transmitted infections.
  --(2) Increasing the distribution of condoms. In Thailand, increasing 
        the use of condoms in commercial sex establishments has led to 
        a decrease in HIV prevalence from 3.6 percent in 1993 to 2.5 
        percent in 1995 (a 30-percent drop).
  --(3) Changing high risk sexual behavior through behavior change 
        communication. In Uganda, this approach has resulted in a 35-
        percent reduction in HIV prevalence in young women aged 15-24 
        through a program encouraging delayed onset of sexual activity 
        and safer sexual practices.
    Overall, since 1989, USAID-funded programs have educated over 15 
million persons, trained over 150,000 persons as educators, improved 
STI programs in 19 countries, and distributed over 200 million condoms.
                              surveillance
    Question. The Institute of Medicine reported in its 1992 ``Emerging 
Infections'' report that the surveillance of diseases needs to be 
improved both within the U.S. and overseas. Of the 15 recommendations 
made in the IOM report,the first five are all related to improving 
disease surveillance. It also recommends that the National Institutes 
of Health, the Department of Defense and the Centers for Disease 
Control all work together toward this goal.
    (A) Could you please take a moment to discuss what the U.S. 
currently does to monitor the outbreaks of infectious diseases abroad 
and what U.S. agencies are involved?
    Answer. Several U.S. Government agencies are involved in 
surveillance, including the Department of Defense (DOD); the Department 
of Health and Human Services (DHHS), including the Centers for Disease 
Control and Prevention (CDC); the Department of State; USAID; and to a 
lesser degree, the U.S. Customs Service, and Departments of Agriculture 
and Transportation.
    To focus on the major players, the Department of Defense monitors 
outbreaks through its own extensive system of reporting, which includes 
its laboratories overseas. The Department of Health and Human Services, 
especially through the Centers for Disease Control and Prevention, has 
an extensive informal network of epidemiology and laboratory 
connections, with reporting channels for the World Health Organization 
as well. USAID's Office of Foreign Disaster Assistance is also involved 
in surveillance as well, although primarily at a second stage; that is, 
in keeping up with outbreak situations, including notifications from 
embassies, and from its networks of emergency and disaster relief 
organizations.
    USAID's focus in surveillance is in the development of host country 
capabilities in surveillance, a critical element in assuring 
sustainable and effective surveillance over the long run. USAID is 
particularly active today in supporting polio surveillance which may 
serve as the foundation for integrated surveillance in some African 
countries.
    (B) What are your views on what can be done to improve monitoring 
capabilities and prevent a widespread epidemic?
    Answer. Inadequate in-country capabilities for epidemiologic 
surveillance and inadequate incorporation of epidemiologic principles 
into health systems' operations are major hindrances to the recognition 
and timely control of infectious diseases, including Emerging, 
Reemerging and Infectious Diseases (ERID's).
    Acute outbreak epidemiologic investigations are invaluable tools 
when they are required. At least equally important, however, but 
sometimes overlooked, are systems to monitor epidemiologic trends over 
time--for example, changing patterns of antimicrobial resistance, 
changing risk groups for illnesses, new population groups being 
affected, etc.
    Health systems which lack systems to identify and monitor ``usual'' 
patterns of disease often will not be able to recognize ``unusual'' 
events or outbreaks of new problems, or changes in the patterns of 
previously ``controlled'' diseases. Therefore, health systems without 
routinely available and applied epidemiologic expertise, without the 
interest and mandate to monitor diseases and investigate outbreaks, and 
without budget, support-staff, and transport for epidemiologic 
activities will, predictably, have difficulties recognizing and 
containing ERID's.
    To have adequate in-country epidemiologic capabilities requires not 
only specialized, epidemiologically-sophisticated professional staff, 
but also dedication of substantial health system resources to support 
routine as well as ``emergency'' epidemiologic work.
    Note: Each country needs, at the very least, a core group of well-
trained epidemiologists. In smaller countries, it may be wishful 
thinking that the rare, trained epidemiologist(s) will be able to work 
full-time on epidemiology; however, it is important that this highly 
trained resource should be immediately available, and used, at least 
for urgent work on putative outbreaks.
    To sustain this commitment over time (i.e., between emergencies) 
requires health system managers, and political leaders, to understand 
and accept the value of investments in epidemiologic work. Competent 
epidemiologic capacity cannot be established on an emergency basis in 
response to sudden crises. Competent epidemiologic capacity must pre-
exist outbreaks. Few developing country governments judge the 
expenditures and efforts to maintain competent epidemiology systems to 
be worthwhile investments when compared to other demands. USAID plays a 
critical role in building this capacity through training and 
institutional strengthening.
    In addition, a portion of USAID's funding is made available to deal 
rapidly with potentially catastrophic or epidemiologically important 
outbreaks, ranging in scale from such circumstances as the Ebola 
outbreak in 1995, to recent investigations of the potentially 
important, resurgences of monkeypox and O'nyong-nyong fever in central 
Africa.

                         conclusion of hearing

    Senator Leahy.  So I thank all five of you or all six of 
you who have testified here today or who have briefed us, as 
Dr. Heymann has today, and thank you very much for being here.
    The subcommittee will stand in recess subject to the call 
of the Chair.
    [Whereupon, at 12:15 p.m., Thursday, May 15, the hearing 
was concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]