[Senate Hearing 108-139]
[From the U.S. Government Printing Office]




                                                        S. Hrg. 108-139

      GLOBAL HIV/AIDS AND SEVERE ACUTE RESPIRATORY SYNDROME (SARS)

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

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                     APRIL 8, 2003--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations


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


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                      COMMITTEE ON APPROPRIATIONS

                     TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky            TOM HARKIN, Iowa
CONRAD BURNS, Montana                BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama           HARRY REID, Nevada
JUDD GREGG, New Hampshire            HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah              PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado    BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio                    TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas                MARY L. LANDRIEU, Louisiana
                    James W. Morhard, Staff Director
                 Lisa Sutherland, Deputy Staff Director
              Terrence E. Sauvain, Minority Staff Director
                                 ------                                

 Subcommittee on Departments of Labor, Health and Human Services, and 
                    Education, and Related Agencies

                 ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
JUDD GREGG, New Hampshire            ERNEST F. HOLLINGS, South Carolina
LARRY CRAIG, Idaho                   DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas          HARRY REID, Nevada
TED STEVENS, Alaska                  HERB KOHL, Wisconsin
MIKE DeWINE, Ohio                    PATTY MURRAY, Washington
RICHARD C. SHELBY, Alabama           MARY L. LANDRIEU, Louisiana
                           Professional Staff
                            Bettilou Taylor
                              Jim Sourwine
                              Mark Laisch
                         Sudip Shrikant Parikh
                             Candice Rogers
                        Ellen Murray (Minority)
                         Erik Fatemi (Minority)
                      Adrienne Hallett (Minority)

                         Administrative Support
                             Carole Geagley


                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening statement of Senator Arlen Specter.......................     1
Statement of Julie Gerberding, M.D., M.P.H., Director, Centers 
  for Disease Control and Prevention, Department of Health and 
  Human Services.................................................     2
    Prepared statement...........................................     4
Statement of Hon. Elias Zerhouni, M.D., Director, National 
  Institutes of Health, Department of Health and Human Services..     8
Statement of Hon. Anthony S. Fauci, M.D., Director, National 
  Institute of Allergy and Infectious Diseases, National 
  Institues of Health, Department of Health and Human Services...     9
    Prepared statement...........................................    12
Opening statement of Senator Thad Cochran........................    21
    Prepared statement...........................................    23
Questions submitted by Senator Arlen Specter.....................    29

 
      GLOBAL HIV/AIDS AND SEVERE ACUTE RESPIRATORY SYNDROME (SARS)

                              ----------                              


                         TUESDAY, APRIL 8, 2003

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:03 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter, Cochran, Harkin, and Murray.


               opening statement of senator arlen specter


    Senator Specter. Good morning, ladies and gentlemen. The 
Appropriations Subcommittee on Labor, Health, Human Services, 
and Education will proceed.
    I walked into the hearing room and saw all of the directors 
of the National Institutes of Health. I had a strong sense that 
we ought not to have called you to Capitol Hill today but ought 
to have left you in your research institutes to proceed with 
your important work. But funding is a very big part of your 
work. So we welcome you here.
    The funding stream for the NIH has been the envy of, I 
think, every other federally-funded organization, which would 
include the Department of Defense. Nobody has had a doubling of 
funding over such a brief period of time. And that is in 
recognition of the outstanding work which NIH has done on 
making such unique advances on so many of the dreaded diseases.
    With the funding has come, I think, a higher visibility for 
NIH. It is hard to give NIH higher visibility than it always 
has had. But I think that is true. And that has raised 
expectations so that the number of people who come to you and 
candidly who come to this subcommittee is enormous, telling us 
about their children's ailments principally, their ailments, 
their parents' ailments. And they want to know why more is not 
being done.
    So that puts a very heavy burden on the National Institutes 
of Health to do more. But there is--as individuals, we have 
nothing, if we do not have our health. We all know that. Dr. 
Zerhouni is too young to really be focused on that in this 
point in his career.
    We had added to the hearing today the age issue and brought 
in the Centers for Disease Control. And in their intervening 
time, the issue has arisen on the epidemic on SARS. The morning 
media is filled with the specification on that problem, as 
articulated yesterday by Dr. Gerberding, Dr. Fauci at another 
Senate hearing. We are calling on the CDC to do more and more 
with less and less. I do not know how that works out 
mathematically. Perhaps the subcommittee can be informed today 
by the astute and brilliant witnesses whom we have here.
    But the SARS issue is very, very pressing on the world and 
on the United States and more so soon on the United States. And 
we are asking the CDC to do a great deal on the AIDS issue. We 
are asking the CDC to do a great deal on homeland security. And 
for some inexplicable reason, there is a reduction in the CDC 
request by $152 million. So I am sure Dr. Gerberding can tell 
us how everything can be accomplished, more and more with less 
and less.
    Our distinguished ranking member will be joining us 
shortly. He has been delayed. But we will proceed at this time. 
And our initial focus is on the AIDS issue, but we will want to 
talk about SARS as well. Our first witness is Dr. Julie 
Gerberding, Director of the Centers for Disease Control. She 
also serves as associate clinical professor of medicine at 
Emory University. Her B.A. and M.D. degrees are from Case 
Western, her internship, residency, and served as chief medical 
resident at the University of California, San Francisco, and 
her masters of public health at the University of California, 
Berkeley.
STATEMENT OF JULIE GERBERDING, M.D., M.P.H., DIRECTOR, 
            CENTERS FOR DISEASE CONTROL AND PREVENTION, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Senator Specter. Welcome, Dr. Gerberding. We are going to 
use the lights, which are 5-minute lights. More recently, I 
have been recounting, when talking about time limitations, 
about a recent memorial service held for Ambassador Annenberg. 
And the time limit for the speakers, including Former President 
Gerald Ford and Secretary of State Colin Powell and Arlen 
Specter and others, was set at 3 minutes. So I want you to know 
how generous a 5-minute allocation is.
    Dr. Gerberding, if you run over, we will not flash any 
lights. The floor is yours.
    Dr. Gerberding. Thank you. I am really pleased to be here 
this morning. I think it is an honor to be able to provide this 
information and perspective on the important issues that are 
facing CDC and the Nation. But I also think it is remarkable 
that I am sitting here with Dr. Zerhouni from the NIH and my 
colleague, Dr. Fauci, and all of the other institute directors.
    Secretary Thompson has put a large emphasis on trying to 
get better horizontal integration in HHS. And we truly are 
working together collaboratively as a team. So some of the 
things I am talking about this morning are certainly not just 
CDC issues. They are issues that we are working on side by 
side, day to day. And there are many others that we could tell 
you about in the future.
    I am going to start by talking a little bit about SARS, the 
global epidemic that we are dealing with right now. The cases 
internationally continue to mount. We have more than 2,600 
cases. In the United States as of the end of the day yesterday, 
we had 148 cases that were suspected. We have had no deaths in 
the United States. But, of course, we are concerned that we may 
see people with the more severe end of the spectrum of the 
illness.
    We are working very fast and very hard at CDC to understand 
where this came from and where it is going to go. The leading 
hypothesis still is that it is caused by a corona virus, a new 
agent that is genetically dissimilar from the other known 
corona viruses that usually cause the common cold in people and 
more serious disease in veterinary animals and birds.
    But the corona virus does appear to have a genetic sequence 
that is unique. We are finding it in more and more patients. We 
are seeing that people who are sick are developing antibodies 
to corona virus, which is really strong evidence that it is 
causing the condition. And we are releasing test results now 
for corona virus to the state health departments that are 
taking care of the suspected patients. Actually, in just a 2-
week period of time from isolating the virus until the present 
time, we have been able to develop three potentially useful 
diagnostic tests that will help us a lot in understanding who 
really has it and how it is being transmitted.
    This is a problem that in the United States is still 
primarily among people who have traveled to the parts of Asia 
where the disease is prevalent. You can see that it is a global 
distribution in large part because of the travelers. But we 
have had now five cases spread here domestically to household 
contacts of travelers and three cases in healthcare workers who 
have taken care of these patients.
    We have put out a great deal of guidance. Our communication 
system has had more calls a day from the public than we ever 
did at the peak of anthrax. On some days, we have more than 
1,500 calls for information and requests on this topic. So we 
are working very hard.
    The two main things that we are doing right now to prevent 
transmission are, number one, alerting travelers that when they 
return to the United States, that they should see a doctor if 
they are ill within 10 days of their arrival. And second, we 
are alerting all clinicians that if they see a patient with an 
unexplained respiratory illness who has traveled to Asia or 
other areas where this is endemic, that they need to think 
about SARS and isolate the patient until they have evidence to 
suggest that this is not the case.
    So this is a global emerging infectious disease. We see 
this pattern of emergence time and time again. But this one is 
particularly noteworthy because it does appear, at least in 
some cases, to spread very efficiently from person to person.
    We learned our lesson with HIV infection. And if I can show 
the next graphic, the President in his 2004 budget made an 
announcement about an extremely important global HIV 
initiative, to really prevent HIV and to provide care and 
treatment to the some 40 million people internationally who 
have this condition. CDC has a very important role to play in 
this. We have $294 million in the President's 2004 request for 
our global AIDS programs, in particular for the maternal to 
child transmission prevention work that we will be doing in 14 
countries, in Africa, in the Caribbean, and in Asia.
    This a program to, first of all, identify mothers who are 
infected with HIV and to get them on drug treatment, so that 
their children are not infected. We have some very specific 
goals there and are interested in moving that along.
    On the next graphic--I think we can just go to the last 
graphic. I could not finish testimony here without appreciating 
how much you, Mr. Chairman, and Senator Harkin have done to 
support the buildings and facilities at CDC to make all this 
good work possible. On this slide, this building right here is 
the building that is currently undergoing completion as the new 
bioterrorism laboratory facility where we will be able to do 
state-of-the-art work in the best possible, high-level 
containment facilities.


                           PREPARED STATEMENT


    The building next to it is where we are now working on 
anthrax and SARS and some of the other emerging infectious 
diseases. So we really appreciate so much the support you have 
given. And the Secretary and the President in the 2004 budget 
have continued to understand how important these buildings and 
facilities are to us.
    Thank you.
    [The statement follows:]
             Prepared Statement of Dr. Julie L. Gerberding

                              INTRODUCTION

    Mr. Chairman, Senator Harkin, other distinguished members of the 
Subcommittee, I am Julie L. Gerberding, Director of the Centers for 
Disease Control and Prevention, and Administrator of the Agency for 
Toxic Substances and Disease Registry. Thank you for the opportunity to 
appear before you today on behalf of the Centers for Disease Control 
and Prevention (CDC). Our mission is to protect the health and safety 
of the American people through activities that range from combating 
global HIV/AIDS, to preparing our public health system for public 
health emergencies like bioterrorism, to controlling the spread of 
infectious diseases like severe acute respiratory syndrome (SARS). 
These responsibilities require an aggressive approach to leadership and 
management that allows CDC to balance emerging issues with our vision 
for safer, healthier people in every community.

                          GLOBAL AIDS PROGRAM

    Under the leadership of the White House Office of National AIDS 
Policy and with other parts of HHS, and the U.S. Agency for 
International Development (USAID), CDC is working to implement the 
President's International Mother and Child HIV Prevention Initiative, 
announced last summer. We are also prepared to lend our assistance to 
support the President's Emergency Plan for AIDS Relief, announced in 
the State of the Union address in January. These initiatives are 
vitally important.
    CDC is one of three HHS operating divisions actively involved in 
fighting AIDS worldwide. The National Institutes of Health (NIH) has a 
strong portfolio of basic research in the areas of HIV and 
tuberculosis, including vital efforts to develop a vaccine to prevent 
HIV infection and new treatment technologies and strategies. NIH also 
trains United States and foreign scientists as a critical part of its 
mission. HRSA, with its leadership in care and treatment and rich 
experience in professional education, through an interagency agreement 
with CDC, works internationally to train health care providers to care 
for people living with HIV and AIDS. CDC has engaged in international 
applied AIDS research and programmatic efforts since the beginning of 
the pandemic.
    From Tanzania to Vietnam to Haiti, CDC employees are on the ground, 
working with Ministries of Health, nongovernmental organizations (NGO), 
faith-based groups, and with other U.S. government entities, such as 
the Department of State and the USAID, to develop country-specific 
solutions to the ravages of AIDS.
    Under the HHS Global AIDS Program, CDC works directly with 25 
countries in Africa, Asia, Latin America, and the Caribbean to prevent 
new infections, provide care and treatment to those already infected 
and develop the capacity and infrastructure needed to support these 
programs. We calculate that these 25 countries account for more than 90 
percent of the world's AIDS burden, based on prevalence estimates 
released at the end of last year by the WHO and UNAIDS. Targeting our 
resources to those countries most in need makes sense, and allows us to 
achieve the greatest results for our investment. For fiscal year 2004, 
the budget for the Global AIDS Program is $294 million, including $150 
million for the President's International Mother and Child HIV 
Prevention Initiative, jointly implemented by HHS and USAID. The fiscal 
year 2004 Budget for CDC also includes $11 million for international 
applied prevention research.
    The Global AIDS Program was first funded in fiscal year 2000. It 
builds on HHS's long and successful history of global initiatives to 
promote health, in areas such as immunization. As part of the global 
AIDS program in Thailand, CDC staff worked with the Thai government to 
develop a national mother-to-child HIV prevention program, the first of 
its kind in the developing world. As a result of this effort, testing 
has been implemented in all public hospitals, and it is estimated that 
perinatal transmission has been reduced to less than 10 percent, 
preventing more than 1,000 HIV infections in children each year.
    Today, our highly trained physicians, epidemiologists, virologists 
and other laboratory scientists, and public health advisors are 
providing technical assistance to host-country governments and others 
working to prevent and control HIV/AIDS. CDC staff are often located 
directly in host-country Ministries of Health or their affiliated 
National AIDS Control Programs. Working in close proximity with public 
health and medical colleagues allows CDC experts to enhance their 
services to host-country programs. Staff are also co-located with USAID 
colleagues, promoting complementary programming between the two U.S. 
agencies.
    In addition to HHS employees, the Global AIDS Program currently has 
nearly 400 locally employed staff, who serve in a range of capacities, 
from research scientists, laboratory technicians, nurses and midwives 
to computer specialists, statisticians, sociologists, and support 
staff. One of the primary goals of the Global AIDS Program is to 
develop in-country capacity to address HIV/AIDS. Local staff are 
employed to form a national cadre of trained professionals who can 
share their knowledge with others, developing an ever-growing cadre of 
trained personnel.
    Great progress has been made to date. For example, CDC staff in 
Uganda are helping expand public health and medical information 
systems. Services have dramatically improved thanks to our technical 
and financial support. At The AIDS Support Organization, or TASO, 
essential program information, such as the number of male versus female 
patients, how many patients have active tuberculosis, how many are 
practicing safer sexual behaviors, and so on, is now readily available 
from a CDC database. With specialized training and software, local 
epidemiologists, public health and medical professionals can easily 
produce epidemiologic statistics, surveillance information and data. 
This improved informatics capability provides essential information to 
target prevention services to uninfected partners and children of HIV-
infected persons and to provide needed treatment and care services to 
those living with HIV and AIDS.
    CDC has also improved care and treatment of opportunistic 
infections, tuberculosis being the single most significant culprit. 
Worldwide, one third of AIDS deaths are due to tuberculosis. Although 
globally there has been significant progress with tuberculosis control 
efforts, current trends may be stalling, in part, due to lack of access 
to care and treatment of persons with HIV/AIDS. CDC's successful work 
with the Botswana Ministry of Health serves as an excellent model for 
more broadly integrating HIV and TB care and treatment. The project, 
labeled ``BOTUSA''-for Botswana-USA, aims to develop integrated 
services, while supporting national tuberculosis control. It has 
prevented significant mortalitydeath and morbidity, including the 
prevention of multi-drug resistant tuberculosis, in the face of 
explosive HIV and TB co-epidemics. Lessons learned from this work are 
now being translated to other African GAP country settings.
    All of this work now forms the foundation for HHS support for and 
involvement in the President's Emergency Plan for AIDS Relief, which is 
focused on 14 of the hardest-hit nations, accounting for 50 percent of 
all HIV infections. This five-year plan is expected to prevent seven 
million new infections--60 percent of the projected new infections in 
the targeted countries. Up to two million HIV-infected people will be 
treated with anti-retrovirals, and care will be provided to 10 million 
HIV-infected individuals and AIDS orphans. Implementation will be based 
on a ``network model'' being employed in countries such as Uganda: a 
layered network of central medical centers that support satellite 
centers and mobile units, with varying levels of medical expertise as 
treatment moves from urban areas to rural communities. The model will 
employ uniform prevention, care, and treatment protocols and prepared 
medication packs for ease of drug administration. It will build 
directly on clinics, sites, and programs established through USAID, 
HHS, non-governmental organizations, faith-based groups, and willing 
host governments.
    The first stage of the unprecedented President's Emergency Relief 
Plan is his International Mother and Child HIV Prevention Initiative, 
which has already begun in the same 14 countries and is jointly 
implemented by HHS and USAID. CDC's budget request for fiscal year 2004 
contains $150 million to support this initiative, an increase of $110 
million over the fiscal year 2003 enacted level.
    HHS and USAID staff have worked with host governments and NGO's to 
develop preliminary country-specific plans of action that will target 
one million HIV-infected women annually within 5 years or less, provide 
them with HIV counseling and voluntary testing, essential prenatal care 
and support services and--most importantly--with the life-saving drugs 
that will help their babies be born free of HIV infection. We expect 
that this initiative will reduce mother-to-child HIV transmission by 40 
percent among the women treated. A second goal of the initiative is to 
improve health care systems to provide care and treatment not only to 
mothers and babies, but to fathers, other children, and the broader 
community as well. Strengthening health care systems is essential to 
the success of the President's broader Emergency Relief Plan. Every 
day, an estimated 2,000 infants are born with HIV. Inexpensive, 
feasible treatments are available to save infants from this deadly 
infection, and appropriate care and treatment for family members can 
prevent them from being orphaned. Through the Mother and Child 
Prevention Initiative, we are working to make those treatments 
available in the countries where they are most needed. At the same 
time, we are putting into place the infrastructure that will serve as 
the foundation for the broader care and treatment programs envisioned 
in the President's Emergency Plan for AIDS Relief. We look forward to 
continuing to work with our United States and international partners to 
provide the essential training, technical assistance and financial 
support to governments and scientific institutions around the globe to 
help them help their people.

                SEVERE ACUTE RESPIRATORY SYNDROME (SARS)

    Just as we are committed to combating the growing epidemic of HIV/
AIDS around the world, CDC is engaged in combating emerging infectious 
diseases, as well. Since late February 2003, CDC has provided support 
to WHO in the investigation of a multi-country outbreak of unexplained 
atypical pneumonia referred to as severe acute respiratory syndrome 
(SARS).
    On April 4, 2003, President Bush issued an Executive Order to 
update the list of communicable diseases that are quarantinable, to 
include SARS. The Order also delegated to Secretary Thompson the 
authority to approve Surgeon General regulations designed to prevent 
introduction of communicable diseases into the United States and to 
approve quarantine sites selected by the Surgeon General. While we have 
no plans at this time to seek any use of the expanded authority, we 
took the step of issuing the Executive Order as a prudent precaution, 
so that we would be ready to meet a severe public health risk involving 
SARS in the event that one should develop in the future--which we are, 
of course, working to prevent.
    On Friday, March 14, CDC activated its Emergency Operations Center 
(EOC) in response to reports of increasing numbers of cases of SARS in 
several countries. On Saturday, March 15, CDC issued an interim 
guidance for state and local health departments to initiate enhanced 
domestic surveillance for SARS; a health alert to hospitals and 
clinicians about SARS; and a travel advisory suggesting that persons 
considering nonessential travel to Hong Kong, Guangdong, or Hanoi 
consider postponing their travel. HHS Secretary Tommy Thompson and I 
conducted a telebriefing to inform the media about SARS developments.
    Of the 115 reported suspected cases among U.S. residents, 109 have 
traveled to mainland China, Hong Kong, Singapore, or Hanoi, Vietnam, 4 
had household contact with a suspected case, and 2 are healthcare 
workers who provided medical care to a suspected case. Cases in the 
United States have had relatively less severe manifestations of SARS, 
compared to cases reported in other countries. Forty-three of the 115 
cases have been hospitalized. As of April 3, 2003, twelve remain in the 
hospital, and none have died.
    Cases of SARS continue to be reported from around the world. The 
disease is still primarily limited to travelers to Hong Kong, Hanoi, 
Singapore, and mainland China; to health care personnel who have taken 
care of SARS patients; and to close contacts of SARS patients. Based on 
what we know to date, we believe that the major mode of transmission is 
through droplet spread when an infected person coughs or sneezes.
    CDC is participating on teams assisting in the investigation in 
mainland China, Hong Kong, Taiwan, Thailand, and Vietnam. In the United 
States, we are conducting active surveillance and implementing 
preventive measures, working with numerous clinical and public health 
partners at state and local levels. CDC has deployed approximately 30 
scientists and other public health professionals internationally and 
has assigned almost 300 staff in Atlanta and around the United States 
to work on the SARS investigation.
    CDC has issued interim guidance to protect against spread of this 
virus for close contacts of SARS patients, including in health care 
settings or in the home. We have also issued interim guidance for 
management of exposures to SARS and for cleaning airplanes that have 
carried a passenger with suspected SARS. We have issued travel 
advisories and health alert notices, which are being distributed to 
people returning from China, Hong Kong, Singapore, and Vietnam. We have 
distributed more than 200,000 health alert notice cards to airline 
passengers entering the United States from these areas, alerting 
passengers that they may have been exposed to SARS, should monitor 
their health for 10 days, and if they develop fever or respiratory 
symptoms, they should contact a physician.
    WHO is coordinating daily communication between CDC laboratory 
scientists and scientists from laboratories in Asia, Europe, and 
elsewhere to share findings, which they are posting on a secure 
Internet site so that they can all learn from each other's work. Our 
evidence and that of many of our partners indicate that a new 
coronavirus is the leading candidate for the cause of this infection.
    Rapid and accurate communications are crucial to ensure a prompt 
and coordinated response to any infectious disease outbreak. In the 
past three weeks, CDC has held multiple teleconferences with state 
health officials to provide them the latest information on SARS spread, 
implementation of enhanced surveillance, and infection control 
guidelines and to solicit their input in the development of these 
measures and processes. Secretary Thompson and I, as well as other 
senior scientists and leading experts at CDC, have held numerous media 
telebriefings to provide updated information on SARS cases, laboratory 
and surveillance findings, and prevention measures. CDC is keeping its 
website current, with multiple postings daily providing clinical 
guidelines, prevention recommendations, and information for the public.
    Currently, CDC is recommending that persons postpone non-essential 
travel to mainland China, Hong Kong, Singapore, and Hanoi, Vietnam. 
Persons who have traveled to affected areas and experience symptoms 
characteristic of SARS should contact a physician. Health care 
facilities and other institutional settings should implement infection 
control guidelines that are available on CDC's website. SARS patients 
should not go to work, school, or other public places until at least 
ten days after they are fully asymptomatic. If a SARS patient is 
coughing or sneezing, he should use common-sense precautions such as 
covering his mouth with a tissue, and, if possible and medically 
appropriate, wearing a surgical mask to reduce the possibility of 
droplet transmission to others in the household. It is very important 
for SARS patients and those who come in contact with them to use good 
hand hygiene: washing hands with soap and water or using an alcohol-
based hand rub frequently and after any contact with body fluids.
    For people who are living in a home with SARS patients, and who are 
otherwise well, there is no reason to limit activities currently. 
Contacts with SARS patients must be alert to the earliest symptom of a 
respiratory illness, including fatigue, headache or fever, and the 
beginnings of an upper respiratory tract infection, and they should 
contact a medical provider if they experience any symptoms. The 
experience in the United States has not demonstrated spread of SARS 
from household contacts into the community.
    The SARS experience reinforces the need to strengthen global 
surveillance, to have prompt reporting, and to have this reporting 
linked to adequate and sophisticated diagnostic laboratory capacity. It 
underscores the need for strong global public health systems, robust 
health service infrastructures, and expertise that can be mobilized 
quickly across national boundaries to mirror disease movements. A 
strong and flexible public health infrastructure is the best defense 
against any disease outbreak.

                        BUILDINGS AND FACILITIES

    Our efforts to combat SARS illustrate the critical need for a 
strong public health infrastructure and strong physical infrastructure 
at CDC. As CDC Director, I place the highest priority on rebuilding our 
physical infrastructure. CDC has made substantial progress on master 
planning efforts related to buildings and facilities for its Atlanta-
based headquarters. The following examples illustrate the progress we 
will continue to make in fiscal year 2003 and plan for in fiscal year 
2004.

                       ROYBAL CAMPUS/CLIFTON ROAD

    The new Emerging Infectious Diseases Laboratory currently under 
construction is anticipated to replace 5 existing Roybal Campus lab 
buildings. It will feature a rapid response laboratory for bioterrorism 
events and other public health emergencies; additional ``hot lab'' 
space for esearching the most deadly pathogens; a new training lab; 
and, other infectious disease laboratory space. We expect to occupy 
this key facility in mid-2005.
    A new West Campus Central Utility Plant is under construction. This 
urgently required facility will provide utility support for the new 
Emerging Infectious Disease Laboratory and other facilities.
    The new Scientific Communications Center will allow CDC to much 
more effectively and directly communicate essential scientific 
information to the public health community worldwide. Construction is 
expected to be completed in late 2004, with commissioning and occupancy 
completed by mid-2005.
    Design for a new Headquarters and Emergency Operations Center is 
almost complete. This facility will house CDC's leadership in a secure 
location, provide secure strategic command, control and communications 
during emergencies, house the Agency's permanent Emergency Operations 
Center and bioterrorism personnel, and provide a new data center for 
CDC scientists.
    Design for the new Transshipping Facility and Campus Infrastructure 
Upgrades is underway. This project is intended to provide a single 
point of entry for freight, mail, and packages to the Roybal campus. 
This project will relocate this critical function from the laboratory 
core to outside the security setback zone.
    Detailed project planning is underway for the East Campus Lab 
Consolidation Project. This project consists of a new lab and lab 
support tower to house BioSafety Level two-third lab space, a new 
vivarium, a new insectary, and expanded and modernized central lab 
support functions.

                            CHAMBLEE CAMPUS

    CDC owns 50 acres of property in Northeast Atlanta, approximately 8 
miles from the Roybal Campus. This is the site of the infamous army 
barracks and wooden structures that house important environmental 
health and parasitology work for CDC. To date, eight huts have been 
bulldozed and several new structures are underway or complete. 
Construction for the Environmental Toxicology Lab began in 2002. We 
expect to occupy the building in early 2005.

                               CONCLUSION

    I would like to reiterate my thanks for the opportunity to be here 
to discuss CDC's efforts to combat global HIV/AIDS and to prevent the 
spread of SARS, as well as our progress in updating our buildings and 
facilities. I would like to express my thanks to you, Mr. Chairman, and 
to the members of this Subcommittee, for your continued support of our 
activities to enhance the public's health and safety. I look forward to 
working with Congress to fulfill CDC's essential public health mission, 
and I would be happy to answer any questions you might have.

    Senator Specter. Thank you very much, Dr. Gerberding.
    I am going to yield to my distinguished colleague, Senator 
Harkin, for his opening statement.
    Senator Harkin. Thank you very much, Mr. Chairman. I will 
have some questions about SARS when we get to questions.
    Senator Specter. Thank you very much, Senator Harkin.

STATEMENT OF HON. ELIAS ZERHOUNI, M.D., DIRECTOR, 
            NATIONAL INSTITUTES OF HEALTH, DEPARTMENT 
            OF HEALTH AND HUMAN SERVICES

    Senator Specter. Dr. Zerhouni, Director of the NIH, had 
been the Executive Vice Dean of Johns Hopkins University School 
of Medicine, Chair of the Department of Radiology and 
Radiological Science, and Professor of Radiology and Professor 
of Biomedical Engineering. His M.D. is from the University of 
Algiers School of Medicine. And he completed his residency in 
diagnostic radiology at Johns Hopkins.
    Dr. Zerhouni, we know your participation on this panel is 
brief. And we will be calling on you more extensively on the 
NIH portion of the hearing. But we are interested in your views 
on the AIDS issue and SARS issue, if you wish to proceed.
    Dr. Zerhouni. Well, thank you, Mr. Chairman, thank you, 
Senator Harkin, for your support of NIH. You mentioned it. And 
I would like to really thank you and the committee and your 
leadership for accomplishing the doubling of the NIH budget. 
And I can assure you that all the directors and myself are 
committed to making sure the expectations that have been raised 
are met.
    I would like to be very brief. NIH has worked extensively 
with CDC over the past 2 months on the SARS epidemics. And we 
have mobilized all of our resources across NIH, including 
resources of NHLBI in the clinical center to help and support 
the effort of CDC and the WHO. Dr. Fauci will go into the 
details of our actions.
    In terms of global AIDS, we have also worked very closely 
with the administration and the entirety of NIH to expend our 
efforts in the global scene, because we believe that security 
for our Nation will involve our ability to develop responses 
the world over. SARS is one example of how quickly we can 
respond to emergencies when the investments underneath, the 
investments in research, and the investment also in 
bioterrorism that we have been able to make over the past 2 
years in bioterrorism, the past many years in AIDS, are paying 
off in the absolute incredible speed with which the virus was 
identified and the measures that we are taking that will be 
expounded upon by Dr. Fauci to respond through research to the 
epidemics.
    Senator Specter. Thank you very much, Dr. Zerhouni.

STATEMENT OF HON. ANTHONY S. FAUCI, M.D., DIRECTOR, 
            NATIONAL INSTITUTE OF ALLERGY AND 
            INFECTIOUS DISEASES, NATIONAL INSTITUES OF 
            HEALTH, DEPARTMENT OF HEALTH AND HUMAN 
            SERVICES

    Senator Specter. We turn now to Dr. Anthony S. Fauci. Dr. 
Fauci has appeared so frequently before this subcommittee in 
recent years that we are about to make you an honorary member 
of the subcommittee, Dr. Fauci.
    We ask you to come to this side of the podium to give your 
testimony soon.
    Dr. Fauci is the Director of the NIH Allergy and Infectious 
Disease Institute. He came to NIH in 1968, after completing his 
residency at the New York Hospital Cornell Medical Center. A 
native of Brooklyn, he received his M.D. degree from Cornell 
Medical College.
    Thank you for joining us, Dr. Fauci. And we again look 
forward to your testimony.
    Dr. Fauci. Thank you very much, Mr. Chairman, Senator 
Harkin. It is a pleasure to be here with you again today. 
Before I start, I want to reiterate what Dr. Zerhouni and Dr. 
Gerberding said about the extraordinary collaboration and 
collegiality that has gone between the CDC and NIH, not only in 
HIV, but most recently SARS.
    I also want to take this opportunity to congratulate Dr. 
Gerberding and her colleagues at CDC for the enormous effort 
that they have put into controlling this epidemic, even though 
it is still in its incipient phase. I think we are where we are 
right now because of the extraordinary work of the CDC. And I 
wanted to take this opportunity to mention that to you 
publicly.
    Let me just take a few minutes to talk to you first about 
the international HIV/AIDS epidemic. As you can see from this 
poster, the epidemic is truly global with 42 million living 
with HIV and over 60 million having been infected. In 1984, the 
NIH did their first international HIV/AIDS work in Haiti. And 
then in 1985, in collaboration with the CDC, the very earliest 
collaboration, in Projet SIDA in the former Zaire.
    Since that time, the international HIV/AIDS research 
activity has expanded enormously. As you can see from this map 
with the countries in red in which we have international HIV 
activity, we now have 85 countries with 278 international 
research projects, 28 training grants. Of note and importance 
is that although NIAID is the major player because this is an 
infectious disease, 15 NIH institutes are involved in this 
collaborative effort. So it is truly an NIH effort.
    Some of the activities that have gone on in these projects 
are briefly outlined here. I do not have time to go through all 
of them. But as you can see, they cover the spectrum from 
community-based programs to training and infrastructure, 
therapeutic approaches, vaccine development, and prevention.
    With regard to the prevention effort, we have efforts that 
are quite complementary to what is going on with the CDC with 
their global AIDS program. We have our prevention trials 
network, our vaccine trials network. And now, given the 
President's Emergency Plan for AIDS Relief to provide therapy, 
care, and prevention, we will be doing research in the arena of 
therapy, which we hope will inform the best way to treat 
individuals within the context of their own country and to 
build the infrastructure so that they can carry it out 
themselves without us. That is our ultimate goal, to create a 
situation where there will be a lasting infrastructure within 
the country. By infrastructure, I mean intellectual capital and 
the skills to treat individuals.
    Let me quickly go on to spend a minute on SARS, which you 
mentioned and for which Dr. Gerberding has described the work 
of the CDC. This is a slide, Mr. Chairman, that I have shown on 
multiple occasions to this committee. And I keep adding 
diseases to it. It is a map of this country showing just within 
the last 20 years reemerging and emerging diseases. Emerging 
disease is a disease like HIV/AIDS, in which there is no prior 
experience, Reemerging is something that we have experienced 
over the past few years, such as West Nile Virus. It is a 
disease we knew about, but not in this part of the world. And 
now it is in this country. SARS is an example of truly an 
emerging new disease.
    Many of these have very minor impact. You might have cases 
that are dozens, handfuls, that are restricted to a geographic 
area. Every once in a while, you have an emerging or reemerging 
disease that has global impact. Clearly, SARS has already 
graduated to that point. But as Dr. Gerberding said, we are not 
clear at this point in time where it is going to go, because it 
is truly an evolving epidemic.
    Dr. Gerberding mentioned the prevailing evidence, very 
strong evidence, that this is a corona virus. We, as 
researchers at the NIH, are assuming that this is true, and I 
believe it is true. And we are now performing accelerated 
research in order to develop the countermeasures against this 
particular disease.
    Prior to this, there were already at least 20 NIH grantees 
involved in corona virus research. Because, after all, corona 
virus are very common groups of virus. The one we are seeing 
now with SARS is much different, although it falls within that 
class.
    Then finally, this is just a brief sketch of some of the 
NIH research endeavors that have already started. The CDC 
isolated the virus, and gave it to the NIH investigators. And 
now we have started on everything from the basic research in 
understanding how this virus works, to the sequencing of the 
virus, to the determinations of its pathogenic capabilities. Of 
importance is that although the virus itself may damage the 
body and the lungs, there may be an immunological component, 
because we know that there are many viruses--not many, but at 
least a few--whose damage to the body is not only the virus 
pathogenesis, but an immune response, such as respiratory 
syncytial virus and measles.
    The most important work right now is going on with 
vaccines. We took the virus that Dr. Gerberding and her 
colleagues gave to the NIH. We are growing it very vigorously 
in culture, which in some respects is quite good news, because 
the fact that you can grow it means that you can then go to a 
first generation of a vaccine, namely a killed, inactivated 
vaccine, which we will be putting into an animal model, I would 
predict, within the next few months, so that hopefully within a 
year or a little bit more we will have at least proved the 
concept in an animal model that a vaccine might be able to 
work. How long it will take to get a vaccine that will be 
useable in humans will obviously be subject to the vicissitudes 
of the science.
    Then there is drug screening, on which we are collaborating 
with the CDC, and USAMRIID. Immune-based therapy, for example, 
taking people who have recovered from infection, isolating 
their immunoglobulins that have shown that they can protect or 
at least recover the person from SARS and using passive 
infusion. These protocols are now being developed at the NIH in 
collaboration with the CDC.
    Finally, we have clinical research, which we will be 
conducting at the clinical center in much the same way as we 
did in the very early years of HIV/AIDS.

                           PREPARED STATEMENT

    So in summary, Mr. Chairman and Senator Harkin, I provided 
you with briefly two cogent examples of emerging infectious 
diseases that have important international implications. 
Together with HHS and our other partners, particularly the CDC, 
the NIH is poised and eager to meet these domestic and 
international threats to the public health. And I want to close 
by thanking you and this committee for your vision and 
generosity in providing for us, over so many years, the 
resources to meet these critical challenges.
    Thank you.
    Senator Specter. Thank you very much, Dr. Fauci.
    [The statement follows:]

               Prepared Statement of Dr. Anthony S. Fauci

    Mr. Chairman and members of the Committee, thank you for inviting 
me here today to discuss two global health threats, HIV/AIDS and Severe 
Acute Respiratory Syndrome, or SARS. These are just two among many 
threats we face from emerging and re-emerging infectious diseases--
which include the threat of bioterrorism. I will first discuss the 
international aspects of the NIH research program on HIV/AIDS. I will 
then outline how NIH has responded to SARS in the six weeks that have 
passed since this disease was first recognized. I will close with a few 
thoughts on how the United States can strengthen its ability to react 
effectively to global emerging or re-emerging disease threats.

                            GLOBAL HIV/AIDS

    HIV, the emerging virus that causes AIDS, was identified just 20 
years ago. Today, approximately 42 million people worldwide are living 
with HIV/AIDS. HIV/AIDS is truly a global pandemic with no end in 
sight. Sub-Saharan Africa is hardest hit, with more than 29 million 
people infected. South and South-East Asia together account for more 
than 6 million infected people, with 1.2 million more in Eastern Europe 
and Central Asia, and 1.9 million in Latin America and the Caribbean. 
During the past year, approximately 14,000 people worldwide were 
infected with HIV every day. Over the next seven years, it is projected 
that approximately 45 million more people will become infected. Without 
the implementation of effective prevention and treatment measures, it 
is anticipated that by the year 2020 approximately 70 million people 
will have died of AIDS.
    The global impact of HIV/AIDS demands a global response. The 
President's overall budget request for AIDS research at NIH for fiscal 
year 2004 is $2.9 billion, of which $274.7 million will be used for 
research in countries other than the United States. Of course, the 
progress NIH makes in the arena of HIV research will benefit the entire 
world, whether the research is conducted in this country or abroad. 
However, collaborative research conducted in developing countries 
seriously afflicted with HIV/AIDS is highly focused on specific health 
issues that are most critical to the countries in question.
    The NIH international HIV/AIDS research portfolio addresses a broad 
range of HIV-related health issues. NIH currently supports 260 
international AIDS research projects in over 80 countries, as well as 
more than 30 clinical network sites. The NIH international HIV/AIDS 
research agenda includes the development of vaccines and other 
prevention strategies, identification of culturally appropriate social 
and behavioral interventions to stop transmission of HIV, testing of 
therapeutic approaches for HIV and common co-infections such as 
tuberculosis and malaria, discovery of new ways to prevent HIV 
transmission at birth and through breast-feeding, and basic research. 
All of these international AIDS research projects require the direct 
involvement of foreign researchers as equal partners in their design, 
conduct, and analysis. NIH also helps to strengthen research in 
resource-poor countries by training scientists, clinicians, and health 
care workers in research techniques, and by enhancing local laboratory, 
clinical, and data management capabilities. In this regard, in 1999, 
NIH established two large international networks for clinical HIV 
research. One of these, the HIV Vaccine Trials Network (HVTN) evaluates 
vaccines for safety and efficacy, and works to ensure that vaccine 
candidates are appropriate to the regions where they will be used. This 
network currently has sites in 13 countries and soon will be expanding. 
The HIV Prevention Trials Network (HPTN), which currently operates in 
14 countries, evaluates the safety and efficacy of other prevention 
strategies, such as cost-effective drug therapies to reduce mother-to-
infant transmission, behavioral interventions to help prevent sexual 
transmission of HIV, prevention and control of sexually transmitted 
diseases that increase the probability of HIV transmission, and topical 
microbicides that provide a chemical barrier to transmission. In 
addition to these two major international efforts, other NIH-supported 
clinical HIV research networks also are being expanded internationally, 
and are working in close collaboration with the HPTN and the HVTN
    As another example of our global outreach, NIAID in 2001 launched 
an innovative program called the Comprehensive International Program of 
Research on AIDS (CIPRA) to help investigators in developing countries 
carry out comprehensive, long-term HIV/AIDS research tailored to the 
needs of the local population. In order to be eligible, researchers 
must conduct the work in a country with a per capita income less than 
$5,000. CIPRA is specifically structured to allow applicants to build 
comprehensive, multidisciplinary projects from the ground up. The 
program initially helps these scientists to plan a research program, 
establish collaborations, and build administrative and research 
infrastructure. As their research capacity grows, they can seek 
additional CIPRA funding. CIPRA now has three multidisciplinary 
research projects--one in Beijing, China, and two in South Africa. 
Planning and organizational grants have been awarded in Trinidad and 
Tobago, Peru, Zambia, Russia, and Vietnam, among other countries.
    The single most important tool that is needed to fight this 
epidemic is an effective vaccine. One of the most serious obstacles 
that vaccine developers face is the ability of HIV to rapidly mutate, 
which leads to a great deal of heterogeneity in the virus. Thus, a 
vaccine that might work in a part of the world where one form of the 
virus predominates would not necessarily work in another region. NIAID 
recently has developed a candidate HIV vaccine that addresses this 
problem directly. The candidate is designed to induce antibodies that 
can bind to proteins from the three most prevalent HIV subtypes, or 
``clades.'' It is hoped that this new vaccine candidate will provide 
broad protection against all three of these subtypes, which together 
are responsible for approximately 90 percent of HIV infections 
worldwide. A pilot safety trial of this vaccine already is under way, 
and expanded tests conducted through NIAID's HVTN are planned for 
several U.S. sites, as well as sites in Haiti and South Africa. Many 
other vaccine candidates are in various stages of clinical development.
    In addition to vaccines, we are pursuing many other strategies to 
prevent HIV transmission. Some of these have begun to produce results. 
For example, a pivotal NIH-supported study conducted in Uganda 
demonstrated that a single dose of the drug nevirapine given to an HIV-
infected woman at the onset of labor, combined with a single dose for 
the infant just after birth, was 50 percent more effective in 
preventing transmission to the baby than was a short course of the drug 
AZT. Research is now underway to determine if the use of nevirapine or 
other drugs can prevent transmission through breastfeeding, a major 
mode of mother-to-infant transmission. Other HIV prevention strategies 
include development of effective chemical and physical barrier methods, 
research on the use of these methods among different populations, and a 
study of how antiretroviral therapy might prevent transmission by 
reducing how much virus a patient sheds in their genital track or in 
breast milk.
    In the United States and other western countries, potent 
combinations of anti-HIV drugs (highly active antiretroviral therapy, 
or ``HAART'') have dramatically reduced the numbers of new AIDS cases 
and deaths due to HIV/AIDS. Meanwhile, the toll of AIDS has accelerated 
elsewhere in the world, especially in poor countries where expensive 
HAART regimens are beyond the reach of all but a privileged few. 
Fortunately, this disparity in access to life-saving medications may be 
changing. Building on the research infrastructure that NIH has helped 
establish in Africa and elsewhere in the developing world, we are 
actively working with our international colleagues to link the 
provision of anti-HIV therapies to efforts in prevention research, with 
the goal of facilitating a comprehensive approach to the AIDS pandemic 
in poor countries. Implementation of this strategy will be considerably 
enhanced by the recently announced President's Emergency Plan for AIDS 
Relief, which will create an opportunity for us to address important 
operational research questions within the context of the treatment, 
prevention and care components of the President's Plan.
    The development of research infrastructure in the resource-poor 
countries with whom we collaborate is critical to the NIH mission in 
NIH international HIV/AIDS research. Specific international needs 
include the establishment of representative and stable groups of 
volunteers for safety and efficacy studies, as well as increasing the 
number of workers trained in basic, clinical and behavioral research, 
data management, and clinical bioethics. NIH international programs, 
such as the Fogarty International Center's AIDS International Training 
and Research Program, provide traineeships at U.S. academic and medical 
schools. In-country training also is provided in many host nations 
through these programs. A new initiative recently was launched to 
provide foreign researchers who have been trained in the United States 
with pilot funds upon their return to their own country in order to 
ensure their continued capability to conduct AIDS research and continue 
collaborations with their U.S. counterparts. Another new initiative is 
the targeting of training in the area of clinical operational health 
services research on AIDS and tuberculosis. All of these examples 
underscore our belief that the best way to meet the global pandemic of 
HIV/AIDS is through global outreach and collaboration.

                                  SARS

    The world currently is facing a new, evolving and potentially very 
serious infectious disease threat--the Severe Acute Respiratory 
Syndrome or SARS. Only six weeks have passed since SARS was first 
recognized but it already has become a worldwide health emergency, with 
quarantines, travel disruptions, widespread fear, and the threat of 
serious economic damage. As of April 5, 2003, the World Health 
Organization (WHO) had reported more than 2,400 SARS cases in 18 
countries, including 89 deaths. In the United States, 115 suspected 
cases in 28 states had been reported to the Centers for Disease Control 
and Prevention (CDC) as of that date. Since the epidemic is still 
evolving, it is impossible at this time to predict its ultimate outcome 
this year or its potential in future years. However, an effective 
response to this threat must involve both public heath measures and 
biomedical research.
    As a result of the work of the CDC and WHO, as well as NIH and 
other organizations around the world, scientific progress on SARS has 
been swift and impressive. Research led by CDC strongly implicates as 
the cause of SARS a new coronavirus that may have recently crossed 
species from an animal to humans. The suspect virus has been grown in 
the laboratory in cell culture, its genetic sequence has been 
determined, and that sequence has been used to help develop a specific 
diagnostic test.
    NIAID is the NIH institute with primary responsibility for research 
on emerging infectious diseases. In the short time since SARS came to 
the attention of the world, NIAID has made significant contributions, 
many of which were facilitated by the flexibility of NIAID biodefense 
efforts to include work on emerging acute viral diseases. It is clear 
that naturally emerging infectious diseases can be no less a threat to 
global health than the deliberately released microbes of a bioterror 
attack. NIAID efforts related to SARS include the following:
    Surveillance and epidemiology.--NIAID supports a research team in 
Hong Kong dedicated to the surveillance of emerging infectious, 
especially influenza viruses. This group also has identified a 
coronavirus in association with SARS and has been complementary to the 
CDC's efforts. In addition, at the request of WHO, NIAID assigned a 
staff epidemiologist to provide epidemiological and logistical 
assistance in Geneva during the early stages of the SARS epidemic.
    Vaccine Research.--NIAID's intramural research laboratories, 
including the Vaccine Research Center, are already working to develop a 
vaccine to prevent the disease. Of note, researchers in the NIAID 
Laboratory of Infectious Diseases are now actively growing the SARS 
coronavirus in tissue culture for the purpose of developing a vaccine. 
Furthermore, NIAID is collaborating with CDC, FDA, the United States 
Army Medical Research Institute of Infectious Diseases (USAMRIID), and 
other agencies to develop strategies for SARS coronavirus vaccine 
development. NIAID also is consulting with companies and other 
organizations that have reagents, cell lines, animal models, and other 
technologies relevant to vaccine development.
    Therapeutics Research.--NIAID responded rapidly to a request from 
CDC to evaluate candidate antiviral therapeutic agents through a 
collaborative antiviral drug-screening project at USAMRIID. NIAID also 
has initiated discussions with pharmaceutical companies on candidate 
antiviral drugs, and is reviewing a proposal for a clinical trial of 
antiviral therapy to be conducted by members of the Institute's 
Collaborative Antiviral Study Group and the NIH Clinical Center. 
Furthermore, NIAID-supported researchers at Utah State University will 
evaluate the efficacy of existing antiviral drugs against SARS using a 
cell-culture system and similar coronaviruses that infect the human 
respiratory tract, but do not cause disease.
    Clinical Research.--In collaboration with the CDC, NIAID is 
prepared to accept patients with SARS for evaluation and treatment at 
the NIH Clinical Center. Moreover, NIAID-funded extramural research 
laboratories, such as the Respiratory Pathogens Research Unit at the 
Baylor College of Medicine in Houston, have molecular and cell-based 
diagnostic tests for known coronaviruses. The already planned expansion 
of these laboratories in 2003 will increase our capacity to address 
emerging acute viral diseases, such as SARS. NIAID also will support 
clinical trials of candidate vaccines and drugs that are active against 
coronaviruses as they become available.
    Basic Research.--NIAID has a long-standing interest and involvement 
in basic research on coronaviruses (see above) and currently funds 18 
projects in this area; we plan to expand this effort in response to the 
recent outbreak. Also, the study of SARS patients, as well as patient 
laboratory specimens in NIAID laboratories, will be important in 
illuminating the natural history of the SARS agent, its potential 
animal reservoir, its pathogenic mechanisms and its basic biology. 
These studies will in turn help to identify targets for antiviral 
drugs, diagnostic tests, and vaccines.
    Other Activities.--NIAID, together with the NIH Clinical Center 
staff, are collaborating with CDC on technical approaches to confirming 
the identity of the new virus, as well as the clinical management and 
care of SARS patients.

                      BUILDING RESPONSE CAPABILITY

    SARS is only the latest in a long series of emerging and re-
emerging infectious diseases to confront us. We can be quite certain it 
will not be the last. In order to meet these challenges successfully in 
the future, we need a vigorous research program in infectious diseases 
supported by a robust national research infrastructure--including 
strong scientific expertise. Because basic research findings contribute 
to the development of better tools to identify and interdict microbial 
threats, we need our research program to be well integrated with public 
health surveillance and response systems. In order to accomplish these 
ends, NIAID works constantly to strengthen our basic and applied 
research programs on the many host, pathogen, and environmental factors 
that influence disease emergence, while supporting the development of 
diagnostics, vaccines, and therapies necessary to detect and control 
diseases as they appear.
    It is important to make two specific points concerning how we can 
strengthen our ability to respond to emerging infectious disease 
threats.
    First, these threats are global, and modern air travel has 
effectively made the world considerably smaller than it once was. It is 
therefore essential that we work collaboratively with scientists in 
other countries, particularly in developing countries where the burden 
of emerging infectious diseases has an extraordinary impact. NIAID 
funds research on emerging and global infectious disease threats in 120 
countries around the world, and works through the NIH Fogarty 
International Center to carry out training and research programs to 
enhance the skills of scientists in developing countries. Support for 
this kind of international effort is a productive investment that will 
greatly improve our chances of meeting emerging threats quickly.
    Second, research on many diseases must be conducted in specialized 
containment facilities to obviate the threat to laboratory personnel 
and nearby communities. NIAID has established a comprehensive plan for 
building the needed facilities. This plan calls for a national network 
consisting of several Regional Centers of Excellence for Biodefense and 
Emerging Diseases Research, one to two National Biocontainment 
Laboratories with BSL-4 capability, and eight or nine Regional 
Biocontainment Laboratories, rated at the BSL-3 level. NIAID also plans 
to expand BSL-3 and BSL-4 capacity within its own facilities, both on 
the NIH campus in Bethesda and at the Rocky Mountain Laboratory 
facility in Montana. Together, these facilities will provide state-of-
the-art laboratory space to support biodefense and emerging disease 
research, and will allow for a greater ``surge'' research capacity in 
the event of an unanticipated public health threat.

                               CONCLUSION

    After the emergence of SARS, HIV/AIDS, West Nile Virus, drug 
resistant bacteria and other infectious disease threats--including 
bioterrorism--it is clear that emerging or re-emerging infectious 
diseases pose serious threats to global public health and security. At 
NIAID, we accept the challenges that countering these threats pose, and 
are committed to basic and applied research to strengthen the nation's 
ability to cope with both known infectious diseases and those that will 
inevitably emerge in the future.
    Thank you for the opportunity to testify. I would be happy to 
answer any questions you may have.

    Senator Specter. Dr. Gerberding, you were quoted in the 
morning press as saying that the main reason for the low death 
rate in the United States is probably that we have a much 
broader case definition in this country. What do you mean by a 
much broader case definition? And had there been a different 
definition, would there be a difference in reporting death 
cases in the United States?
    Dr. Gerberding. You know, the syndrome, Severe Acute 
Respiratory Disease, has been defined as the pneumonia that is 
caused by this virus. But we know that there is a spectrum of 
illness. And some people who have the infection do not progress 
to that very severe form where they have to be hospitalized and 
often ventilated.
    So our goal was to first of all understand all of the 
people who were carrying it and contain the spread from those 
people. In order to do that, we needed to not just count the 
sickest ones, but we needed to find anybody who had traveled to 
this part of the country and had a fever and unexplained 
respiratory illness. So we have included in our 148 people 
folks who have traveled to Asia and have a fever and a mild 
cough or other respiratory illness, but do not meet the full 
syndrome of the severe pneumonia.
    We did this very purposefully so that we would have the 
broadest net and capture the most people that needed to be 
isolated to protect others. But we know that we have some 
people on this list who probably do not have SARS at all. And 
obviously, by definition, they are less sick than the people 
that are being reported by WHO. On the WHO list, the World 
Health Organization is listing the people who have the severe 
pneumonia. So that is----
    Senator Specter. For people who might be concerned that 
they might have SARS, give us a statement as to what the 
symptoms are, what people should be looking out for, if they 
find certain symptoms that they note about themselves.
    Dr. Gerberding. The most important question is, have you 
traveled to Asia, to the parts of the world where this disease 
is spreading? The second question is, have you had contact with 
somebody who has traveled there or who is known to have SARS in 
the last 10 days? If the answer to either of those----
    Senator Specter. When you say 10 days, if it were a 
different period of time, would there be a different conclusion 
as to exposure?
    Dr. Gerberding. Thank you. Yes. We think the incubation 
period is somewhere between 2 and 10 days, possibly 10 to 12 
days. So if you have not come down with the illness within, 
say, 10 days of your travel, you do not have it.
    Senator Specter. So you either get it within that period or 
you have not.
    Dr. Gerberding. Right. If you are outside of that period, 
you can relax. So if you have been exposed and you have a fever 
or you develop the stuffy nose, headache, tiredness, fatigue 
syndrome that we see with early virus infections, and 
especially if you develop a cough or difficulty breathing or 
shortness of breath, then you should be concerned. Ten days of 
exposure and any kind of fever plus respiratory symptoms is a 
strong indication that you need to contact your clinician and 
get evaluation.
    Senator Specter. The morning press cites the health 
officials as expressing a dual view as to uncertainty about 
whether the epidemic was coming under control or would continue 
to spread. Is there any reason to think that this epidemic is 
coming under control?
    Dr. Gerberding. When you look at the global map and you see 
that the virus is already in so many countries, it means that 
the public health systems in all of those countries would have 
to implement effective containment measures. Here in the United 
States so far, our system has risen to the occasion. And we 
have been doing a good job of preventing spread.
    But in Hong Kong and probably in China, virus has already 
spread in the population. It is going to be very difficult to 
contain it.
    Senator Specter. How have we in the United States done a 
good job in containing the spread?
    Dr. Gerberding. We have done two things. First of all, we 
have alerted incoming travelers. And I can give you a copy of 
this. This is a card that everybody arriving from Asia gets 
that says if you develop any illness within 10 days of arrival, 
you need to get to your clinician. So we are trying to put the 
word out widely among all travelers to that area, that they 
could potentially have been exposed.
    The second thing we are doing is alerting all clinicians. 
On Friday, we had a satellite broadcast, an international live 
broadcast, that included CDC experts, WHO experts, and doctors 
in Asia all talking about SARS to get clinicians educated, to 
think about this illness when they see a traveler coming in 
with a respiratory illness, and to act very quickly to isolate 
them so they do not spread the infection to others.
    Senator Specter. My red light is on. So let me just ask you 
one final question. Dr. Heymann, David L. Heymann was quoted as 
saying we have to be ready for the worst. Dr. Gerberding, what 
is the worst?
    Dr. Gerberding. The worst case scenario that I can imagine 
would be a global pandemic of this illness, which means that it 
would be spreading in the communities in all of the countries 
of the world. We know we are dealing with a virus that can be 
transmitted extremely efficiently from person to person. Some 
people we call super transmitters look like they are especially 
contagious.
    So the worst case scenario would be that we would have 
rapid spread throughout the world before we get the NIH vaccine 
or before we get antiviral therapy to treat people. I do not 
think that is going to happen. But we are looking at that as 
the worst case. And we are doing the things that we need to be 
doing now as fast as we can do them to try to prevent that.
    Senator Specter. Senator Harkin.
    Senator Harkin. Thank you very much, Mr. Chairman.
    Can I go back a step? Dr. Fauci, one question that I was 
asked this weekend was--they heard about SARS. And they said, 
``Well, where did it come from?'' And I said, ``Well, China.'' 
No, that was not what they meant. The question they were asking 
me was, how do these new viruses develop? I mean, how does 
something like this happen? Do they mutate or what? And I said, 
``Well, I will ask the guy who knows.''
    Dr. Fauci. It is not at all an uncommon phenomena that 
diseases that ultimately infect man are diseases that jump 
species from an animal to a man. And when they jump species, 
they have a relatively naive host, at least for the period of 
time until the civilization or the population gets used to it. 
We have not yet definitively proven that that has happened. But 
it is highly likely. There are three known groups of corona 
viruses. Two infect humans, and one is a veterinary type of a 
virus, which we call zoonotic. It infects fowl. It infects 
pigs. It infects dogs and cats. It is likely, and we will know 
that when the full sequencing can be matched, that that is 
exactly what happened.
    We have seen that with HIV/AIDS from chimpanzees to man. We 
see that with influenza that goes generally from fowl and pigs 
to man. It would not at all be an unusual situation.
    Now two things can happen, Senator Harkin, when something 
jumps species. We saw that with the H5N1 in Hong Kong a few 
years ago and most recently where it goes from an animal to a 
human, but it does not have good capability of spreading from 
human to human. So it is a dead end. People can get sick from 
the animal to human, but they do not spread it. We dodged the 
bullet with the H5N1 in Hong Kong, because we could have had a 
serious flu epidemic from that.
    In this situation, it is likely that this jumped from 
animal to human. But the one thing that it did have, the bad 
news about all of this, it now has the capability of spreading 
and spreading relatively well under certain circumstances from 
human to human.
    So that is the reason why we are concerned. There is really 
no need to panic; but we really need to take this very 
seriously, because we are still in the evolving stage of the 
epidemic. And we are not sure entirely where it is going to go, 
what direction, iit will take.
    Senator Harkin. But if the gestation period is 2 to 10, 12 
days, something like that, it would seem to me that that kind 
of lends itself to focusing on where it really started from and 
where it is most concentrated.
    Dr. Fauci. Right.
    Senator Harkin. And I assume that is what is being done 
right now.
    Dr. Fauci. Exactly. Exactly. And that is the reason why the 
individuals who are being--well, there are a couple things that 
are going on. Clearly you need significant precautions, because 
it is very tend--it tends very heavily to go from a patient to 
a healthcare worker or from a person who is in close family 
contact, even though there is some good evidence now that it 
can go beyond that and spread much more easily under certain 
circumstances, as Dr. Gerberding mentioned, with some very 
efficient transmitters.
    But in terms of public health measures, when you have 
someone who is sick, you want to get them to a point where you 
can isolate them so that they do not--or at least make sure 
that they are in a medical facility in which the spread is not 
easily accomplished. The yellow card that Dr. Gerberding 
mentioned to you, as I mentioned in my opening statement, I 
believe is a very important mechanism that has curtailed what 
might otherwise have been even more spread within this country.
    Senator Harkin. Again, I always feel that sometimes when 
these things happen, you have to be careful that you do not 
overblow them. But then you do not want to estimate it either. 
I mean, you have to kind of keep this thing in balance. I do 
not want to--unduly want to get people alarmed. I just--in 
putting this in perspective, how many people die of flu in this 
country every year, Dr. Gerberding?
    Dr. Gerberding. We say that approximately 15,000 people 
die, annually, at least in part due to flu infection or 
complications of flu. So in terms of the magnitude of effect 
right now, we are not seeing anything anywhere near influenza. 
But of course with influenza, we do have a vaccine. And we have 
treatment. And there are things that we can do to protect 
people. With this new corona virus, or whatever it is that is 
causing SARS, we do not have that backup in our system yet. And 
we are just at the very beginning, you know, just a few weeks 
into our experience with it. So we do need to take it very 
seriously.
    Senator Harkin. But 15,000 people die of flu every year in 
this country, right?
    Dr. Gerberding. Correct.
    Senator Harkin. And more in other countries, I assume. I do 
not know what the data is from other countries.
    Dr. Gerberding. Flu is clearly a very prevalent, very 
common respiratory illness during the winter months. And 
unfortunately, not everyone who should get their flu vaccine 
does. And so we continue to see a lot of illness and death from 
it.
    Senator Harkin. I see my red light is on. Thank you very 
much.
    Thank you, Mr. Chairman.
    Senator Specter. Dr. Fauci, when we project the President's 
allocation of $15 billion for AIDS over the next 5 years, what 
is your expectation as to where that money will be spent?
    Dr. Fauci. According to the President's plan, about 52 or 
so percent of it will be on treatment, about 33 percent will be 
on prevention, and about 15 percent on care. It will be 
channeled, according to the----
    Senator Specter. 15 percent where?
    Dr. Fauci. Would go to care of patients.
    Senator Specter. Any of that $15 billion on research?
    Dr. Fauci. The research will not be included in that $15 
billion. The NIH is poised to seize the opportunity of people 
being treated in these developing countries to utilize our 
research funds to be able to inform better how one can treat 
these individuals. And for that reason, we are starting, we 
actually have, our international networks in the countries that 
are targeted countries.
    Senator Specter. Research funds to inform better? What do 
you mean by that?
    Dr. Fauci. Yes. We know in this country the clinical 
networks that we set up years ago, Mr. Chairman, have been very 
influential in allowing us in this country and developed 
nations to understand how to use these drugs, the 
complications, how you can best approach an individual, when to 
start therapy, when to modify therapy. It is unclear how 
populations that have other diseases, that have different types 
of health problems, when you introduce a rather sophisticated 
regime of therapy into that population, how you can best use 
it.
    So the research endeavors that will be performed will be 
performed in order to better inform the clinicians about how to 
use these drugs.
    Senator Specter. Dr. Gerberding, when we take a look at 
your budget, we see the allocation on your buildings being cut 
by $152 million. This subcommittee took the lead 4 years ago, 
after visits by some of us to Atlanta, to see the deplorable 
conditions. And we then added in fiscal year 2001 $175 million 
and supplemented that with $250 million in 2002 and $266 
million in 2003. And I think it is important to note that we 
never heard from the Secretary of Health and Human Services in 
that period of time that there was a problem at CDC in Atlanta. 
It was only when we made the trips there.
    How are you going to get along on $114 million on CDC 
construction allocation which is currently in the budget?
    Dr. Gerberding. First of all, again, we are just very 
grateful for the committee's support of buildings and 
facilities. We know that we would not be where we are today 
without your help. But----
    Senator Specter. Well, are you grateful for the--coming to 
the point, are you grateful for the $152 million cut?
    Dr. Gerberding. We have a 10-year plan. And we have looked 
at that plan at a rate of about $250 million a year. So when we 
do not have the $250 million, it means that we have to slow 
down the pace of accomplishing our master plan. What is the 
good news about the $114 million is that it does allow us to 
build our permanent emergency operations center and/or 
terrorism issues, as well as some of the redundancies in power 
and electricity and basic core functions at CDC where we are 
really vulnerable right now. So we are very appreciative of the 
support for that.
    Senator Specter. And the balance of your budget was cut by 
some $8 million. Aside from the $152 million cut on 
construction, the balance of your budget on the allocation by 
the administration is $8 million less. And you are being asked 
to do more and more and more on AIDS and SARS and homeland 
defense and on the next problem that is going to arise and the 
one after that. Can you handle it with less money?
    Dr. Gerberding. Well, one of the things that we are being 
asked to do, which I really agree with, is we are being asked 
to work more efficiently. And the reductions in the budget 
lines that you do see are reductions in the administration and 
management side, not in programs. So my----
    Senator Specter. So if you increase your efficiency, we can 
reduce budgets.
    Does that go for NIH, Dr. Zerhouni?
    Dr. Zerhouni. Do you want me to----
    Senator Specter. Yes. That was a question, Dr.
    Dr. Zerhouni. Well, clearly, I think from our standpoint, 
we work very closely with the Department and the Office of 
Management and Budget. Obviously, the final calls are always 
made by the President. And we work within the constraints of 
that for----
    Senator Specter. No, they are not, Dr. Zerhouni. They are 
made by the Congress.
    Dr. Zerhouni. I understand, but----
    Senator Specter. The Constitution says the Congress makes 
the appropriations.
    Dr. Zerhouni. I understand. So what we are doing is really 
planning for the maximum impact, if you will, on our primary 
missions and try to in fact find deficiencies in areas that 
could be made more efficient. So I think the efficiency 
approach is certainly something that allows us to look at how 
to deploy the resources given to us in the most mission-
critical areas of the agency.
    Senator Specter. Well, my red light is on, so I will not 
ask another question before yielding to Senator Cochran. But I 
would note this observation. This subcommittee has an overall 
budget for three departments--Health and Human Services, and 
Education, and Labor, so that we are balancing all funds for 
the National Institutes of Health and CDC against programs like 
Head Start and against worker safety on construction jobs and 
on many, many other health items, like rural health.
    So that when this subcommittee gets a total budget, and we 
are going to come to NIH, which has had a very, very modest 
increase, we have to reassess priorities. And it is becoming 
more and more difficult to do. When we started the upward 
spiral of NIH back in 1995, we asked the Budget Committee for 
an additional billion dollars and got turned down and got 
turned down on the floor. And then we found it other places on 
priorities. So having lost on our application for $1 billion, 
we decided the next year to ask for $2 billion. That is the way 
you operate in the Congress. We got turned down again. We again 
found the money.
    But we said to Secretary of Health and Human Services 
Thompson that he is going to have to be a tougher advocate. He 
is going to have to be a tougher advocate. And if you can solve 
the problems on efficiencies, that is great, should have been 
doing that a long time ago, if you can be more efficient.
    But where these funds are indispensable, you are going to 
have to make your case, Dr. Zerhouni, and you are going to have 
to make your case, Dr. Gerberding and Dr. Fauci and all the 
rest of you. And I know it is not easy within the 
administration circles with the controls of the Office of 
Management and Budget. But there was only so much stretch that 
this subcommittee can initiate on the funds we have.
    It is an overall process. And you have to be advocates and 
so do your patients and so do the people who are looking to you 
for help, as part of the overall political process to bring the 
kinds of funds which are indispensable for you to carry on your 
job. This subcommittee is determined not to see you have a cut 
of $152 million on your building program. It is going to bring 
it to a halt. Or $8 million less on operations.
    But advocacies are going to have to be exercised at all 
levels. And you are doubtless the most effective advocates for 
your own program.
    Senator Cochran.

               OPENING STATEMENT OF SENATOR THAD COCHRAN

    Senator Cochran. Mr. Chairman, thank you very much.
    I notice that in the memorandum we have here that our staff 
has prepared, we are given information about the need for 
improving the physical facilities in Atlanta, particularly 
because of obsolete laboratories that need to be replaced or 
modernized and that CDC has implemented a construction master 
plan to consolidate the Atlanta operations into two campuses. 
And we have estimated costs at about $250 million per year.
    Dr. Gerberding, is it your expectation that the budget 
request will be sufficient to meet the needs for this next 
physical year, or should we look to increasing that in order to 
meet this construction master plan that has been developed?
    Dr. Gerberding. I really thank you for the question. Your 
Honor, this is a year of really tough priorities for everyone. 
And we were very grateful that there was a budget line for 
buildings and facilities, because we know how easy it is to 
take it out of the budget altogether. And I think it was a 
great thing to see that there was the support in there for the 
critical structures that we had asked for. And that was for our 
operations center and some of the other things for the physical 
security at CDC.
    When we have a 10-year master plan, if we do not get on 
target every year, that slows the plan down. And so we have to 
regroup and look at what are the options. If we do not get the 
full budget mark in a given fiscal year, that means we have to 
delay construction or accommodate it in some way. And so we are 
looking at ways to do that.
    Senator Cochran. Before the budget submission was prepared 
by the administration, we did not know what SARS stood for. But 
now we do. I think I have it right now, Severe Acute 
Respiratory Syndrome. Well, I notice that yesterday you were 
here testifying in the Senate before the committee chaired by 
Senator Judd Gregg of New Hampshire. And I think that was the 
main focus of that hearing was to look at what was being done 
and what the threat is to the population of the United States.
    In the budget submission, should we look to provide 
additional funding for CDC to be used for work in this area?
    Dr. Gerberding. Right now what we are doing is 
accommodating the SARS outbreak in the United States on sort of 
the foundation of the investments that we have made in 
terrorism and public health preparedness. So we are using the 
operations center that we built for terrorism to coordinate 
this effort. We are using the laboratory surveillance systems 
that we built for terrorism to support this.
    Right now the problem is small enough where we can handle 
the emergency or the crisis with the resources that we have for 
public health preparedness. If this scales up, we are going to 
have to keep a real track of the budget implications, because 
we do not know where it is going to go. And we will need to do 
a good job of documenting what we need or what we have spent in 
order to deal with it.
    Senator Cochran. Well, I know that as we proceed through 
the appropriations process, we will stay in touch with you and 
your staff and be sure that whatever amount we recommend for 
CDC contains funds sufficient to deal with this outbreak.
    Dr. Gerberding. Thank you.
    Senator Cochran. Dr. Zerhouni, welcome. It is good to see 
you again. The last time we were together you were in 
Mississippi. And we appreciated the honor of your visit to our 
State, the first time a director of the National Institutes of 
Health had ever been to our State. So we felt particularly 
grateful for your being there.
    One of the things we talked about and reviewed during that 
meeting was the Jackson Heart Study, which is a step toward 
trying to identify what we can do about health disparities and 
why the African-American community in that part of Mississippi 
has more incidence and problems with heart disease, 
hypertension, and related cardiovascular problems.
    I think I understood from your remarks when you were in 
Mississippi that this is one of the major initiatives of NIH, 
to look at disparities and try to develop a strategy for 
dealing with them. With that in mind, do you expect there is a 
possibility that we could increase review so that it would 
include other areas of the United States, like the Mississippi 
Delta or other places in the United States where research is 
really needed on this subject if we are to deal effectively 
with the problem?
    Dr. Zerhouni. Well, I think--thank you, Senator, for the 
question. And thank you for your hospitality in Mississippi. I 
have to say that Southern hospitality deserves all the good 
words that I heard about it before.
    We wanted to make sure that our health disparities 
portfolio responded to the priorities and to the emerging 
challenge that we see in health disparities. When you look at 
all the progress we have made, we have made tremendous progress 
across diseases, across the population groups of our country. 
But when you look, for example, at a decrease in cardiovascular 
mortality, you realize that even though a decrease in all 
population groups, there still remains a significant difference 
in particular in the African-American populations for heart 
disease. But then when you look at certain regions of the 
country, Southeastern United States suffers from a much higher 
rate of stroke, for example, cardiovascular disease, diabetes, 
and so on.
    As a strategy for NIH, we want to review the entire 
infrastructure for health disparity research in the country. 
And two components of that are going to be very critical. 
Number one is to build the scientific infrastructure that needs 
to be there in the communities that are affected to be able to 
enlighten and inform the best interventions. And the Jackson 
Heart Study is a prototype of that. This is a study conducted 
within the community, in partnership with all the institutions. 
And it is a successful study. It is really a good example of 
how we could do this.
    Now you were referring to the Mississippi Delta and other 
regions. We also are investing, for example, in the stroke belt 
with Morehouse College, for example, and the National Center 
for Primary Care, where we are in fact developing an entire 
network of 136 community centers that could conduct research 
for, in fact, reducing health disparities. The major issues 
that we have is to build the infrastructure as well in the 
areas where health disparities are a problem, as well as 
address the issues from the research standpoint so that we can 
then convey the actions that need to be taken with our partners 
at CDC and others.
    So that is the strategy. And we are looking at the entire 
country in that regard. And we are investing increasingly in 
the infrastructure for research on health disparities.
    Senator Cochran. Thank you very much.

                           PREPARED STATEMENT

    Thank you, Mr. Chairman. Mr. Chairman, I would like for my 
statement to be printed in the record.
    Senator Specter. Without objection, Senator Cochran, your 
full statement will be made a part of the record.
    [The statement follows:]

               Prepared Statement of Senator Thad Cochran

    Mr. Chairman, thank you for holding this hearing on a number of 
very crucial issues. At this important time in our nation, we must 
assure that we are setting clear priorities and investing wisely in the 
health and safety of all Americans. The emergence of Severe Acute 
Respiratory Syndrome (SARS) and the continuing role of America in the 
Global HIV epidemic are evidence that the work of the NIH and CDC is 
critical to the well-being of America and the world.
    The $30 billion proposed in the fiscal year 2004 budget for the NIH 
and CDC to conduct biomedical research and provide public health 
infrastructure is a wise investment because both infrastructure and 
research increase our understanding of disease, improve our ability to 
respond to naturally occurring disease outbreaks, and protect our 
nation from terrorist attacks.
    In funding the NIH and CDC, we must anticipate and plan for events 
such as the SARS virus. We know that we will constantly face 
unanticipated threats and we should be prepared for them. When we do 
not provide adequate funding, our public health officials cannot 
respond as quickly as is needed and are forced to shift resources.
    We have also found that these unanticipated issues do not go away. 
We are still dealing with the West Nile Virus and will likely deal with 
SARS for years to come. I am pleased that the committee is examining 
these issues and I hope we will continue to provide the resources for 
research and facilities that are needed to prepare for and respond to 
whatever threats may emerge.
    I am pleased that funding for the National Institutes of Allergy 
and Infectious Disease has increased from the 2002 level of $2.5 
billion to a proposed level of $4.3 billion in fiscal year 2004. This 
investment in research will result in the knowledge and understanding 
that will lead to new treatments for infectious diseases such as HIV/
AIDS, West Nile Virus and SARS.
    However, over that same time frame, funding for HIV/AIDS and other 
infectious disease research funding at the CDC has grown at a much 
slower rate. [HIV/AIDS funding increased by about $53 million from a 
fiscal year 2002 level of $835 million to $887 million in fiscal year 
2003. In addition, funding levels for the National Center for 
Infectious Disease at the CDC have slightly decreased from the fiscal 
year 2002 level of $348 million to just over $343 million in fiscal 
year 2003. The fiscal year 2004 proposed level is $332 million.]
    We must adequately fund both public health infrastructure and basic 
research in order to counter infectious disease threats. We know these 
two components work together. It is my hope that we will increase 
funding for all of these vital activities. Thank you.

    Senator Specter. Senator Harkin.
    Senator Harkin. Just a couple follow-up questions on the 
global AIDS situation. Dr. Gerberding, do you have any data on 
how much different organizations are spending for the drugs 
that keep people healthy, the retroviral-type drugs that keep 
healthy? There is like three drugs that go into kind of a 
cocktail or something like that that people take in this 
country and it has shown to be effective for keeping HIV under 
control. Do we have any idea about how much we are spending 
globally to administer all the people, like in sub-Saharan 
Africa? How much did we say, about 29 million persons living 
with HIV right now? Do we have any idea how much we are 
spending just on healthcare?
    Dr. Gerberding. We can get you information about what is 
being spent right now. I will be happy to do that for the 
record. I think in this country we have many drugs to choose 
from. And the combination therapy that you mentioned for 
treatment of AIDS is the standard of care. And it is quite 
expensive. But the pharmaceutical companies have made the 
decision to work toward lowering drug prices so that drugs can 
be equitably purchased and be made available at prices that are 
affordable, even in developing countries.
    There has been a huge change in philosophy and direction. 
And it is exactly that change in the pricing structure that 
allows us to be optimistic that the President's initiative 
really can get in there and include, as Dr. Fauci said, not 
just prevention services, but also care and treatment. But we 
can get you the specifics on that.
    [The information follows:]

                Anti-Retroviral (ARV) Treatment Programs

    Implementing successful ARV programs require much more than simply 
purchasing the drugs themselves. Drug regimens associated with ARV are 
very complicated often requiring taking multiple pills, multiple times 
a day. In addition, medical monitoring is necessary to ensure that ARV 
therapies are effective. To successfully implement ARV programs, 
countries require both a physical and medical infrastructure. Related 
costs in supporting anti-retroviral treatment programs include but are 
not limited to the following: development of guidelines for safe and 
effective ARV therapies and patient monitoring; hiring and training 
qualified health care workers; and implementing distribution systems 
including transportation, storage facilities, quality controls and 
systems to track inventory, etc. One of the key elements of CDC's 
Global AIDS Program is to build infrastructure and capacity to support 
comprehensive programs of HIV/AIDS prevention, care and treatment. In 
fiscal year 2002, CDC spent approximately 11.4 percent of its global 
AIDS budget on care and treatment activities, including care and 
treatment for TB and other opportunistic infections. In addition, 47.5 
percent of the budget was spent on building infrastructure and capacity 
in countries to deliver successful programs.
    In fiscal year 2003, CDC is supporting pilot projects to determine 
how best to meet infrastructure needs in individual countries and be 
able to implement ARV therapy in the most effective way. CDC funds 
partners who purchase ARV therapy, and therefore, CDC does not pay for 
it directly. Their negotiations with suppliers result in various 
prices.

    Senator Harkin. I would like to delve into that.
    Dr. Fauci, do you have something to add?
    Dr. Fauci. Yes, Senator Harkin. Currently in sub-Saharan 
Africa, as an example, there are only about 50,000 people that 
are under therapy. Most of that comes from the purchase of 
people who can afford it. And the prices now in the area that 
we are talking about generally are either generics or markedly 
reduced price. So, for example, in the Uganda situation, where 
there are about 7,000 people who are under therapy, the average 
that they pay for a triple combination that you mentioned is 
between $350 and $450.
    There are also some programs in which the----
    Senator Harkin. That is per year.
    Dr. Fauci. Yes, per year, per year, which is considerably 
less than the drug prices in a developed Nation like the United 
States and in Western Europe. But, for example, as a Nation, 
there are very few programs that are organized programs in 
which treatment is being distributed. And that actually is the 
rationale for the President's Emergency Fund for AIDS Relief, 
which would get 52 percent of that $15 billion into the actual 
treatment of people, at least in the targeted 14 countries, 12 
in sub-Saharan Africa and 2 in the Caribbean.
    Senator Harkin. I am told by the AIDS Healthcare Foundation 
that you are right, that in Uganda and places like that, they 
could get this anti-retroviral drug for about $300 a year, 
maybe $350, I do not know, but around $300 a year; that in 
other parts of the country, it is up to $1,500, same drugs, and 
it costs $15,000 a year here for the same drugs in the United 
States. Does that sound right?
    Dr. Fauci. $15,000 may be a little high, somewhere around 
$12,000, if you include some of the----
    Senator Harkin. $12,000. If someone has HIV in the United 
States, they are paying $12,000 a year for an anti-retroviral 
drug that people--that could be made generically and that could 
be and is being administered in Africa for $300 to $350 a year.
    Dr. Fauci. Right.
    Senator Harkin. That is true.
    Dr. Fauci. That is true. And that is the difference 
perennially between a generic----
    Senator Harkin. Well, I mean, that just really--this is a 
question you should not have to answer. Maybe I will just make 
the statement. That just seems to me to be outlandish, that 
someone in the United States who is suffering from HIV, has to 
pay $12,000 to $15,000 a year for a drug that is readily 
available for $300 a year. Something is wrong. And if we could 
get it for $300 a year, it would seem to me--what I want to get 
a handle on is how much money are our taxpayers, I assume the 
worldwide community, putting into healthcare on AIDS? And are 
they buying the drugs for $15,000 or $5,000 or $10,000 when 
they could be getting them for $300 a year? And we have to get 
a handle on this, because I take it from our dialogue here that 
those drugs are available at that price, at around $350 or $400 
a year or something like that, they are available.
    Dr. Fauci. They are available either as generics or as out-
of-patents drugs. And that gets into the argument, as you know, 
very complicated, that at least in NIH and CDC is not something 
that we can get involved with----
    Senator Harkin. I understand that.
    Dr. Fauci [continuing]. That has all to do with the 
relationship between generic drugs and their prices and then 
what would the drug companies do if all of a sudden they had no 
profit margin? They would stop making drugs. It is that balance 
that we keep hearing about back and forth.
    Senator Harkin. Well, somebody is making them for $300 or 
$400.
    Dr. Fauci. Yes.
    Senator Harkin. And I cannot imagine they are making them 
and losing money.
    Dr. Fauci. Yes. But the problem is they do not make the 
investment of the hundreds and hundreds of millions of dollars 
to develop the drug. The generics just produce them. And that 
is the perennial argument between the big companies and the 
generics.
    Senator Harkin. But the generics cannot do it until the 
patent runs out.
    Dr. Fauci. Right. Right. Well----
    Senator Harkin. They have had the patent protection, Mr. 
Fauci.
    Dr. Fauci. Yes. But the--for example, the group in India, 
the Sipler Group, that is using the drugs, those patents have 
not run out yet. And they are still making them in generic.
    Senator Harkin. Thank you, Senator.
    Senator Specter. Thank you, Senator Harkin.
    Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman. I know 
you want to go to the second panel. I just wanted to ask a 
couple questions about SARS.
    As you know, Washington State is a gateway to Asia. And we 
are very concerned about a lot of what we are hearing. A lot of 
my constituents travel back and forth there several times a 
year. And we are concerned about the health impact and the 
potential economic impact in Washington State. And I know that 
CDC has issued warnings to many passengers who may have 
traveled to a particular region or country. But as you know, 
when you get on a plane, you do not know where it has been 
before.
    I am just curious if CDC is working with the international 
air carriers and talking with them about how they can reduce 
the spread of SARS.
    Dr. Gerberding. Yes, we are. First of all, WHO has issued 
an alert to the departure airports in Asia to screen passengers 
for any respiratory illnesses that could be consistent with 
SARS. And I do not know to what extent those countries have 
been able to implement the advice yet, but there is an effort 
under way to alert not just the passengers when they arrive 
here, but passengers before they get on a plane in the first 
place, which really makes a lot of sense.
    We are doing a number of things to assess the health status 
of airplanes. And we have just completed or are about to 
distribute a short video for passengers that you will be able 
to watch on an international flight that explains what SARS is 
and what to do. We are working with the airline industry about 
should they detect somebody in flight, what are the sensible 
precautions that could be taken until you get the plane on the 
ground and alert the quarantine officer in the port of entry.
    Then finally, should you have a patient with SARS on a 
plane, what is the appropriate way to disinfect the airplane 
and so on and so forth. And then that also leads to concerns 
among the crew of airplanes about their own personal safety and 
what kind of precautions do they need and what is really the 
air quality on airplanes. So these are all questions that we 
are aggressively pursuing answers to and doing the best we can 
to build up sensible precautions in the interim.
    Senator Murray. And you are working with international air 
carriers, as well as----
    Dr. Gerberding. Yes. We are working with international air 
carriers and the International Association of Flight 
Attendants. And we are also doing some research, looking at 
cohorts of people who have traveled on planes with someone in 
retrospect who is recognized to have SARS so that we can 
understand among the passengers who were potentially exposed, 
does anybody get SARS? If so, where were they in the airplane, 
what kind of exposure did they have, and so forth.
    So we are doing that with international partners through 
WHO. And I think that will really help give us the science base 
from making additional recommendations.
    Senator Murray. And you are following the planes as well as 
the passengers.
    Dr. Gerberding. Exactly.
    Senator Murray. The other question I had has to do with 
healthcare workers. I have noticed that many of the individuals 
who have contracted SARS are healthcare workers. What are you 
doing within our own country to notify emergency room 
personnel, doctors and others, so that they are watching for 
this?
    Dr. Gerberding. We are doing a number of things. We did 
do--on the 14th of March, CDC activated its operations center 
to step in and deal with this epidemic. On the 15th, we issued 
the initial alert to clinicians across the United States and 
the initial guidance on how to isolate patients and how to 
protect themselves. And we have been updating that regularly. 
You can find that on our web page.
    In addition, we have set up a series of regular conference 
calls with clinician professional organizations around the 
country to give them the latest updates so that they can 
redistribute it to their members. Many of us are going around 
the country speaking to clinician groups. For example, I was 
just at the American College of Physicians, where I addressed 
5,000 internists, sort of the kind of people that an adult with 
a respiratory illness might seek attention from.
    Friday we did a global satellite video conference for 
clinicians around the world to tell them about recognizing SARS 
and how to isolate and take care of the patients. So--we also 
operate a hotline for clinicians in the United States. They can 
call up and get information from CDC experts on how to manage a 
patient and so forth. So we are being as aggressive as we can 
to put the word out, take a travel history if you see someone 
with a respiratory illness. And if there is any question, 
isolate the patient until you have additional information to 
show that it is not necessary.
    Senator Murray. And one last question. Oftentimes us 
getting information to minority populations is difficult, 
especially with something like this. We want to make sure the 
Asian communities are aware. Are we doing language, different 
language, information pamphlets or information so that we make 
sure everybody has all the information they need here?
    Dr. Gerberding. Yes, we are. There are several things 
happening. That travel alert that I am sorry you do not have a 
copy of, but we will get you one, is in several Asian 
languages. And we will be adding Spanish to that, also.
    We have just last week established something that we are 
calling sort of the Asian community team at CDC to pull in our 
in-house experts with language skills and cultural experience 
in various Asian communities to try to help us assess how can 
we do a better job of targeting our communication, but also 
being sensitive to the potential for bias or stigma attached 
with this.
    The last thing that we want to have happen here is that our 
Asian communities would suffer unfair prejudice as a 
consequence of this illness. This is not an illness of Asians. 
It is an illness of people who have been in a particular part 
of the world where the virus is spreading.
    So we will be expanding on our Web site more information in 
additional languages. And the WHO Web site is translated into 
several Asian, at least some Asian languages to help people get 
information off the Internet that way. There is a lot more we 
can do.
    Senator Murray. Okay. Very good. Thank you very much, Dr. 
Gerberding.
    Senator Specter. Thank you, Senator Murray.
    Dr. Gerberding, we thank you for your participation. If you 
would like to be a director of the NIH or one of the 
institutes, you may stay.
    If you choose to retain your current position at CDC, you 
are free to excuse yourself. Thank you very much for joining 
us.
    Dr. Gerberding. Thank you. I think I will keep to my 
present job.
    Dr. Zerhouni. We would not mind having her as a director at 
NIH.
    Dr. Gerberding. Thank you.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Specter. There will be some additional questions 
which will be submitted for your response in the record.
    [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 Arlen Specter
               cdc global aids program and arv treatment
    Question. What percentage of the GAP budget of $184 million in the 
current year is dedicated to operational research on life-saving 
antiretroviral treatment?
    Answer. Approximately 13 percent of the fiscal year 2003 budget for 
the Global AIDS Program (GAP) [excluding the $40 million earmarked by 
Congress for the President's mother-to-child HIV prevention initiative] 
is directed to care and treatment efforts, including operations 
research on antiretroviral therapy (ART). GAP is supporting or 
initiating pilot HIV care and treatment projects that include ART in a 
number of countries in Africa and Asia. These pilot projects, which 
have been developed in collaboration with the Ministry of Health of 
each country could, given adequate funding and expanded infrastructure, 
be rapidly expanded to provide care and treatment for large numbers of 
HIV-infected persons in the next few years. They will provide 
operational research data to develop antiretroviral treatment programs.
    Question. How much of the $40 million increase in the current 
year's appropriations is supporting operational research on ARV 
treatment delivery?
    Answer. Since all of the $40 million increase is earmarked for the 
International Mother and Child HIV Prevention Initiative, none is 
budgeted for operational research on antiretroviral treatment delivery. 
Some of the funds will be used to support HIV care for women and their 
family members who receive services to prevent mother-to-child HIV 
transmission. Country program plans are in development and budgets will 
be allocated after plans are approved by the Initiative Steering 
Committee, headed by the White House Office of National AIDS Policy.
    Question. Should that percentage be higher, given the urgency of 
President Bush's goal of bringing 2 million people in developing 
nations into treatment?
    Answer. The goal of providing ART to 2 million people is part of 
the larger initiative President Bush announced in the State of the 
Union in January. The initiative will be based on a ``network model'' 
being employed in countries such as Uganda. This involves a layered 
network of central medical centers (CMCs) that support satellite 
centers and mobile units, with varying levels of medical expertise as 
treatment moves from urban to rural communities. The model will employ 
uniform prevention, care, and treatment protocols and prepared 
medication packs for ease of drug administration. It will build 
directly on clinics, sites, and programs established through the U.S. 
Agency for International Development, the Department of Health and 
Human Services, non-governmental organizations, faith-based groups, and 
willing host governments. Operational research will inform 
implementation of this model.
    Question. President Bush has included an additional $110 million 
next year for CDC GAP. What percentage of that do you anticipate would 
go to operational research on ARV treatment?
    Answer. These funds have been requested for the International 
Mother and Child HIV Prevention Initiative, which includes care and 
treatment of mother and child following birth and, where capacity 
exists, providing care and treatment for eligible family members. While 
we don't anticipate spending any of this funding directly on 
operational research, we anticipate spending about 10-15 percent of 
MTCT funding for monitoring and evaluation, which will provide data for 
operational research.
    Question. What is the status of current ARV operational research 
efforts?
    Answer. CDC staff are currently working with Ministries of Health 
in GAP-affiliated countries to conduct operational research to address 
country-specific questions about scaling up pilot programs to the 
national level. The majority of these programs are still in 
development. A program in Kenya recently began treating patients. 
Programs in Uganda and Thailand will begin treating patients in the 
next few months.
    Question. How many pilot ARV clinics do you have in your program?
    Answer. Currently, CDC supports four pilot clinics in the treatment 
programs, one that has begun in Kenya and one in Uganda and two in 
Bangkok, Thailand that will begin soon. In addition, CDC has been 
supporting the U.N. Drug Access Initiative (DAI) in Abidjan, Cote 
d'Ivoire, since 1998. The DAI continues to provide antiretroviral 
therapy to more than 2,000 HIV-infected adults and children in six 
clinics in Abidjan, despite the ongoing civil wars in the northern and 
western parts of the country.
    Question. What was the selection process used in choosing those 
partners?
    Answer. CDC collaborates with the Ministry of Health in each 
country to identify sites in which to develop and implement HIV care 
and treatment projects. Most of these projects include several other 
collaborators. For example, the HIV care and treatment pilot program 
for residents of the Kibera Slums in Nairobi, Kenya, is a collaborative 
project with the Kenya Ministry of Health, KEMRI (the Kenya Medical 
Research Institute), KICOSHEP (Kibera Community Self Help Programme, a 
community-based organization in Kibera since 1991), AMREF (the African 
Medical and Research Foundation), Mbagathi Hospital, and GAP/Kenya.
    Question. Where are those clinics, and what is their current 
patient census overall?
    Answer. The clinics for the HIV care and treatment pilot are 
located in:
  --The Kibera Slums in Nairobi, Kenya
  --The Tororo Health District in rural Uganda (near the southern 
        border with Kenya)
  --The Drug Relief Center at the BMA College & Vajira Hospital and the 
        methadone maintenance outpatient clinics at Taksin Hospital in 
        Bangkok, Thailand
    The patients for the program in Nairobi are being selected from 
voluntary counseling and testing sites in Kibera, which has a 
population of more than 500,000. The patients for the project in rural 
Uganda will be selected from more than 2,000 participants in an ongoing 
safe water vessel and cotrimoxazole project, while the patients for the 
project in Bangkok will be selected from participants attending 
methadone maintenance clinics located in two large hospitals.
    Question. How many patients in these clinics are now in ARV 
treatment?
    Answer. The only GAP-supported pilot HIV care and treatment program 
providing ART is the Kibera Project in Kenya, where approximately 200 
(as of May 2003) patients have started ART.
    Question. How many patients are scheduled for ARV treatment this 
year?
    Answer. In CDC funded projects, during the next 12 months, the care 
and treatment project in Kenya plans to enroll 500-1,000 patients, the 
project in Uganda about 1,000, and the one in Thailand approximately 
150. By the end of 2003, more than 1,000 total patients could be 
enrolled in these three programs, depending upon when the projects in 
Uganda and Thailand begin.
    Question. What is the overall time frame for the operational 
research on ARV treatment through GAP?
    Answer. The funding cycle for HIV care and treatment projects is 
usually 3 years, but CDC plans to continue supporting these 
antiretroviral therapy programs and collecting operational research 
data through monitoring and evaluating these programs for the 
foreseeable future.
    Question. Who will pay for purchase of medications at these sites--
antiretroviral medications as well as opportunistic infection 
medications?
    Answer. CDC provides funding and technical support for these HIV 
care and treatment pilot programs. For the three projects described 
above, CDC provides funding for medications, including antiretroviral 
therapy and those for opportunistic infections, to selected 
collaborating organizations, which in turn purchases drugs for the 
program. In Kenya, AMFAR purchases drugs for the program. In Thailand, 
the Bangkok Metropolitan Administration (BMA) will purchase the 
medications for the project. In Uganda, TASO (The AIDS Support 
Organization), the first indigenous AIDS organization in Africa and a 
major collaborator in the project, will purchase the drugs.
    Question. Who will pay for staff and laboratory costs?
    Answer. In most of these projects, the collaborating organizations 
or institutions provide staff, but CDC often supports additional staff, 
as well as most, if not all, of the laboratory testing.
    Question. What effort was made to draw on expertise from ARV 
treatment programs in the United States, particularly those developed 
under the CARE Act?
    Answer. CDC has drawn heavily on the experience with treatment 
programs in the United States. Many technical staff working on CDC's 
Global AIDS Program (GAP) worked on U.S. HIV care-related projects 
before joining GAP. Moreover, CDC collaborates with Health Resources 
and Services Administration (HRSA), the government agency that 
administers the Ryan White CARE Act. In particular, CDC funds a HRSA-
managed program (I-TECH) to provide training and technical assistance 
for international HIV care programs that CDC supports. I-TECH is 
designed to draw on expertise from the network of AIDS Education and 
Training Centers in the United States. CDC has also initiated 
partnerships with 10 universities to provide technical assistance. 
Collaborators from these universities (Harvard Medical School; Baylor 
College of Medicine; Howard University; University of North Carolina at 
Chapel Hill; University of California, San Francisco; Tulane 
University; University of Medicine and Dentistry in New Jersey; 
University of Maryland; Columbia University; and Johns Hopkins 
University) have extensive experience with ARV programs in the United 
States. Finally, CDC funds other U.S. national organizations, such as 
the National Alliance of State and Territorial AIDS Directors (NASTAD) 
and the Association of Public Health Laboratories (APHL) that have 
provided support related to HIV care, such as program management and 
laboratory services.

                          UGANDA ARV TREATMENT

    Question. What plans does CDC GAP have to study and support through 
operational research ``ramp up'' of ARV treatment delivery to large 
numbers of Ugandans? How many patients there are now on ARV's?
    Answer. The number of HIV-infected persons in Uganda has been 
estimated between 800,000 to 1.9 million. Of these, only 5,000-10,000 
are estimated to be receiving ART (antiretroviral therapy) in the whole 
country. The CDC-Uganda Program is currently providing both financial 
and technical support at two important institutions for HIV care in 
Uganda: the Mildmay Center, located in the outskirts of Kampala; and 
the Mulago Hospital in Kampala. CDC has provided financial support and 
technical assistance to the Mildmay Center over the past two years to 
build capacity of health care providers working at the Mildmay Center 
and from health care venues throughout the country. In the past year, 
approximately 70 percent of the support that this facility receives was 
provided by the CDC. Between 5,500 and 6,000 HIV-positive persons are 
cared for at the Mildmay Center, including approximately 1,000 
children. Approximately 750 persons are receiving ART at this center. 
The facility not only acts as a state-of-the art HIV/AIDS clinic, but 
also a training center in HIV care and laboratory diagnostics. CDC-
Uganda has recently supported the development of a model Pediatric HIV 
outpatient clinic and training center at the Mulago Hospital, which is 
the National Referral Hospital for Uganda. The model facility involves 
collaboration between the CDC, its University Technical Assistance 
Program (UTAP) partner the Baylor College of Medicine, and the 
Government of Uganda. These two projects aim to improve and expand 
access to care for HIV-positive patients residing in Kampala and the 
immediate surrounding area and to serve as centers for training and 
referral. Furthermore, CDC, in conjunction with The AIDS Support 
Organization (TASO), will soon launch a rural ART pilot project in the 
districts of Tororo and Busia. The Home-Based AIDS Care Project (HBAC) 
is a pilot project that aims to provide comprehensive treatment, 
including ART and TB care, to 1,000 HIV-infected persons and their 
families, including children with HIV. This project is the outgrowth of 
the Safe Water Vessel Project, a two-year-old collaboration between CDC 
and TASO-Tororo, which provides safe water and cotrimoxazole to 750 
households of HIV-positive persons living in the district of Tororo. 
HIV-positive persons and their families currently participating in the 
Safe Water Vessel Project will be among the first evaluated for 
enrollment into the Home-Based AIDS Care Project. This program will 
provide comprehensive care and ART treatment to HIV-infected persons 
and will serve as a model for expanding ART care to rural communities 
in Africa. New patients, referred to the CDC Clinic in Tororo by TASO, 
will also be considered for enrollment.
    We estimate that CDC-implemented programs will increase the total 
number of people on ART in Uganda by 20 percent in the next year. 
Moreover, the CDC/TASO Tororo pilot program has been designed to answer 
fundamental questions to inform ART scale-up efforts for Uganda in 
particular and Africa in general.
    Question. Is CDC's AIDS clinic with UNAIDS in Uganda operational?
    Answer. CDC has worked closely with the UNAIDS Drug Access 
Initiative since its inception. The success of this program has been 
documented in published articles in scientific journals as well as 
through meetings in Uganda and internationally. The program supports 
the use of ART at five centers in Uganda. Although CDC provided free 
testing for CD4 cell counts and viral loads to accurately monitor 
patient care, participants purchased the medications themselves. All of 
the centers involved in this initial pilot project are currently 
providing ART care and have greatly expanded service in the last 2 
years.
    Question. There are other major community-based pilot treatment 
sites in Uganda, such as AIDS Health care Foundation's Masaka clinic 
with 200 patients in care. Have they and others been invited to 
participate in the GAP Program?
    Answer. Since 1998, CDC has collaborated with other organizations 
in Uganda working on ART-based care for persons with HIV/AIDS. As a 
partner in the UNAIDS Drug Access Initiative, CDC provided technical 
support to the Joint Clinical Research Center, Mildmay, Mulago 
Hospital, Mengo Hospital, Nsambya Hospital, and the Ministry of Health, 
which together provide almost all of the ART care outside of private 
clinics in Uganda. CDC has provided advice to the AIDS Healthcare 
Foundation's Masaka clinic since its origin, and communicates regularly 
regarding technical matters of providing ART care, including laboratory 
testing to its 100 patients on ART. CDC has a similar relationship with 
the Academic Alliance for AIDS Care and Prevention in Africa, a U.S. 
and Canadian university collaboration with Mulago Hospital and Makerere 
University to improve training related to HIV/AIDS care in Uganda. CDC 
as well as the other major partners working in HIV/AIDS care, are a 
part of the national committee developing ART guidelines.
    Recently CDC, through the University Technical Assistance Program 
and the International Training and Education Center on HIV (I-TECH), 
which is funded by CDC and administered by the Health Resources and 
Services Administration, has expanded its resource base to include 
leading academic institutions from the US, including Baylor College of 
Medicine; the University of Washington; and the University of 
California, San Francisco. Collaborations with these U.S.-based 
institutions, and the Mulago Teaching Hospital, the Tororo District 
Hospital, TASO-Tororo and the Mildmay Center, allow CDC to be at the 
forefront of advancing programs for the care of children and adults 
with HIV/AIDS both in urban and rural environments. CDC supports many 
other HIV/AIDS-related projects and programs in Uganda, often through 
direct collaborations with WHO, UNAIDS, UNICEF, USAID, the AIDS 
Information Centre, Makerere University and others.
    Question. What role will CDC GAP's pilot ARV projects play bringing 
large numbers of patients into treatment?
    Answer. The pilot ARV projects supported by CDC are playing an 
important role in bringing large numbers of patients into care and 
treatment. Through pilot projects like these, Ministries of Health 
gain: (1) critical information about how to establish and manage large 
HIV care programs, (2) an experienced cadre of clinicians, program 
managers, and other staff who will become trainers and technical 
assistance providers in their countries as programs expand, and (3) 
strengthened critical human and physical infrastructure and referral 
patterns needed to provide expanded services.
    Question. Dr. Gerberding was asked at the hearing how much CDC is 
paying for anti-retroviral medications deployed overseas compared to 
U.S. pricing for such medications: She said she did not have that data, 
that the pharmaceutical industry was doing a good job at lowering 
prices, and she promised to provide data. How soon will we have such 
data?
    Answer. CDC does not pay for these commodities directly, but rather 
funds partners, e.g., BMA, TASO, Univ/MOH, to purchase them. Their 
negotiations with suppliers result in various prices. Therefore, we do 
not have access to their pricing data. Through the President's Mother 
and Child HIV Prevention Initiative and the larger Emergency Plan for 
AIDS Relief, we hope to have access to therapies at sharply reduced 
costs, due to economies of scale and negotiated agreements.

                         HONDURAS ARV TREATMENT

    Question. Does GAP have any presence in Central America? If not, 
why not? Honduras seems a particularly compelling area in need. It 
accounts for more than half of the AIDS cases in all of Central 
America. The official government estimated countrywide HIV prevalence 
is 1.9 percent in 2001 although surveillance studies in SPS in 2002 
revealed almost a 7 percent rate among pregnant women, a 12 percent 
rate among commercial sex workers and a 15 percent rate among men 
having sex with men. The estimated overall prevalence in the San Pedro 
Sula area per local experts is 7 to 10 percent. The estimated number of 
adults and children living with AIDS in Honduras at the end of 2001 was 
57,000 with 14,000 current living orphans. Why has Honduras not been 
prioritized?
    Answer. CDC has not been active in Honduras, but expects to open a 
regional office by the end of the year to provide technical assistance, 
especially regarding surveillance, in Central America, including 
Honduras. That office will be located in Guatemala and is a cooperative 
effort of both CDC and the United States Agency for International 
Development (USAID). Collectively, the needs of developing countries in 
preventing HIV infection and in providing care and treatment for those 
already infected far outstrip the fiscal and human capacity of CDC's 
Global AIDS Program. Providing substantial financial support for 
national ART programs is beyond our capacity at this time; therefore, 
collaboration with others, including USAID and the Global Fund To Fight 
AIDS, TB, and Malaria (GFATM) is essential. The GFATM is funding a 
number of ARV treatment projects, including projects in Honduras.
  --The government of Honduras has been granted $26 million from the 
        Global Fund for AIDS/TB/Malaria, of which it states it will 
        decrease by at least 50 percent AIDS mortality and 
        hospitalizations (source ). CDC's website says it will identify countries 
        with an expressed interest in ARV deployment (). 
        Since Honduras has need for assistance and has financial 
        resources through the fund for ARV deployment, has CDC GAP 
        considered Honduras? If not, how soon can it do so?
    Honduras was approved by the Global Fund for a grant of $20.5 
million over five years to undertake a major scaling-up of the 
country's campaign against HIV/AIDS, tuberculosis and malaria. The 
United Nations Development Programme, the UN's global development 
network, will implement and oversee the venture. CDC will provide 
technical assistance to Honduras in this effort as requested, through 
its regional office in Guatemala, when that office is operational later 
this year.

                         CONCLUSION OF HEARING

    Senator Specter. Thank you all very much for being here. 
That concludes our hearing.
    [Whereupon, at 10 a.m., Tuesday, April 8, the hearing was 
concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]